risk assessment research activities

• Research article
• Open access
• Published: 12 April 2021

A risk assessment tool for resumption of research activities during the COVID-19 pandemic for field trials in low resource settings

• Suzanne M. Simkovich   ORCID: orcid.org/0000-0003-2462-0856 1 , 2 , 3 ,
• Lisa M. Thompson 4 ,
• Maggie L. Clark 5 ,
• Kalpana Balakrishnan 6 ,
• Alejandra Bussalleu 7 , 8 ,
• William Checkley 1 , 2 ,
• Thomas Clasen 9 ,
• Victor G. Davila-Roman 10 ,
• Anaite Diaz-Artiga 11 ,
• Ephrem Dusabimana 12 ,
• Lisa de las Fuentes 10 ,
• Steven Harvey 2 , 13 ,
• Miles A. Kirby 14 ,
• Amy Lovvorn 9 ,
• Eric D. McCollum 15 ,
• Erick E. Mollinedo 16 ,
• Jennifer L. Peel 5 ,
• Ashlinn Quinn 17 ,
• Ghislaine Rosa 18 ,
• Lindsay J. Underhill 1 , 2 ,
• Kendra N. Williams 1 , 2 ,
• Bonnie N. Young 5 ,
• Joshua Rosenthal 17 &

HAPIN Investigators

BMC Medical Research Methodology volume  21 , Article number:  68 ( 2021 ) Cite this article

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The spread of severe acute respiratory syndrome coronavirus-2 has suspended many non-COVID-19 related research activities. Where restarting research activities is permitted, investigators need to evaluate the risks and benefits of resuming data collection and adapt procedures to minimize risk.

In the context of the multicountry Household Air Pollution Intervention (HAPIN) trial conducted in rural, low-resource settings, we developed a framework to assess the risk of each trial activity and to guide protective measures. Our goal is to maximize the integrity of reseach aims while minimizing infection risk based on the latest scientific understanding of the virus.

We drew on a combination of expert consultations, risk assessment frameworks, institutional guidance and literature to develop our framework. We then systematically graded clinical, behavioral, laboratory and field environmental health research activities in four countries for both adult and child subjects using this framework. National and local government recommendations provided the minimum safety guidelines for our work.

Our framework assesses risk based on staff proximity to the participant, exposure time between staff and participants, and potential viral aerosolization while performing the activity. For each activity, one of four risk levels, from minimal to unacceptable, is assigned and guidance on protective measures is provided. Those activities that can potentially aerosolize the virus are deemed the highest risk.

Conclusions

By applying a systematic, procedure-specific approach to risk assessment for each trial activity, we were able to protect our participants and research team and to uphold our ability to deliver on the research commitments we have made to our staff, participants, local communities, and funders. This framework can be tailored to other research studies conducted in similar settings during the current pandemic, as well as potential future outbreaks with similar transmission dynamics.

The trial is registered with clinicaltrials.gov NCT02944682 on October 26. 2016 .

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The spread of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and resulting coronavirus disease 2019 (COVID-19) has led to the temporary suspension of many non-COVID-19 related research activities worldwide. Where feasible, studies are considering remote data collection by telephone or web-based conferencing [ 1 , 2 , 3 ]. However, this approach is often not possible when performing anthropometric measurements, specimen collection, or when investigators need to make other direct observations. Even temporary suspension of research activities can potentially cause harm if investigators are evaluating an intervention that is hypothesized to be beneficial. Further, the suspension of data collection could result in loss of study power and potentially introduce bias. Every day, we are gaining a greater understanding of the transmissibility of SARS-CoV-2, and this knowledge increases our ability to safely resume a wide variety of non-COVID-19 related research activities [ 3 , 4 ]. Where local law or institutional regulations permit activities to restart, investigators need to evaluate the risks and benefits to both research staff and participants of resuming data collection. To safely conduct study activities, researchers need to develop standardized procedures that are based on realistic assessment of these risks, provide guidance on where and when they are manageable, as well as how to minimize the risk with physical distance measures and appropriate personal protective equipment (PPE).

Investigators in the Household Air Pollution Intervention Network (HAPIN) trial initially suspended data collection due to the pandemic in March 2020 and have since restarted collection of behavioural, environmental, biological and clinical measurements during the fifth year of a five-year, multi-country trial [ 5 , 6 , 7 , 8 ]. HAPIN is a randomized controlled trial in rural areas of Guatemala, India, Peru, and Rwanda that is assessing the health benefits of providing liquefied petroleum gas (LPG) stoves and an 18-month supply of free LPG to 3200 households that otherwise depend on solid biomass fuel (wood, animal dung, or crop residue) for cooking. Measurements of cooking behavior, personal and in-home exposure to air pollution, biological samples and clinical measurements are being collected longitudinally from pregnant women and their newborns in every household, along with an older, non-pregnant adult woman, if she resides in the house [ 5 , 6 , 7 , 8 ]. Our study involves home visits, as well as visits to health centers and hospitals during the woman’s pregnancy and the first year of the child’s life.

As SARS-CoV-2 spread globally, governments in all four countries implemented public safety restrictions that limited activities to those designated as essential. Essential activities varied across settings and during the initial period of restrictions. Research activities were not considered essential. However, LPG delivery for cooking was considered essential in all four countries. In Guatemala and Rwanda, our research teams were permitted to continue delivering LPG to study households without disruption. In India, the gas companies continued to deliver refill tanks to study participants. In Peru, our team was limited in its ability to deliver gas during the initial weeks of the restrictions, but we were later able to re-establish services with a local gas company for delivery.

With permission to continue delivery of the LPG intervention, we immediately implemented changes in our delivery protocols to minimize SARS-CoV-2 risk. Further, in anticipation of the additional easement of movement restrictions in countries around the world, we reviewed the literature for guidance on strategies researchers have used for assessing the risk of activities during COVID-19 or other pandemics, and found a dearth of available guidance. Perhaps the most relevant existing framework is that proposed by Lumeng and colleagues, which was designed for research focused in clinical settings in the U.S.A. Thus, we developed a risk assessment tool with the guiding principle of ethical research to minimize the potential risks to research staff, participants and rural communities participating in the HAPIN trial research settings. We wanted our risk assessment tool to allow researchers to assess the risk of each study activity utilizing the same general criteria to support management decisions across this large multinational, multi-disciplinary study with both competing and complementary activities. Although our risk assessment tool has been designed within the framework of specific activities of the HAPIN trial, we report here on our approach, which can be applied to other research contexts and questions in similar settings.

In developing our risk assessment tool, we drew on a combination of expert consultations, government regulations, national and local expertise, institutional guidance and review of emerging literature. We queried our multi-national panel of investigators and field team leaders from across the trial with expertise in the disciplines of clinical medicine and imaging, nursing, environmental science, epidemiology, behavioral science, community engagement and statistics, along with the trial funders who provide scientific guidance to the HAPIN trial. We sought input from local community leaders, the Ministries of Health, universities and non-governmental organizations regarding appropriate operations and safety concerns. We consulted with the Institutional Review Boards (IRBs) and Data and Safety Monitoring Board (DSMB) presiding over the trial regarding resumption of activities. We drew upon historical occupational health frameworks for infectious disease biosafety and risk assessment and the most recent peer-reviewed and grey literature about infection dynamics. We also considered staff experience. Using all of these inputs, we built a framework to evaluate risk of exposure to SARS-CoV-2 [ 3 ]. Our intent was to develop criteria that were clear, simple and actionable for field managers and staff to implement, and to recommend appropriate practices and materials, in accordance with the risk level of each procedure and perceived risk threshold.

While SARS-CoV2 research findings are still emerging, our assessment is based on the consensus that aerosolization and droplet carriage of virus, primarily from coughing, sneezing, singing, crying, talking, are the predominant modes of infection. It is unclear how long the virus remains in the air. Fomites from surface contact may also contribute to transmission, but are likely a smaller risk. Evidence of SARS-CoV-2 presence has been detected in urine, stool, breast milk, semen and blood, but we are not aware of documented transmission through these bodily fluids at the time of this publication. Furthermore, the risk of transmission is greatest in the two days preceding onset of symptoms and continues afterward for at least ten days, and up to twenty days in immunosuppressed patients. Because documented asymptomatic carriage has been widely reported, we assumed that any staff member, collaborator or community participant might be shedding the virus. Small children (especially infants) appear to be infected at the same rate as adults, but have more mild disease and thus may be unknowingly spreading disease. We agreed that viral transmissibility and the true prevalence of COVID-19 are not clearly known in any of our study sites due to limited testing. We also note that recent seroprevalence studies have reported that case burdens are likely underreported. As such, we chose to err on the side of caution and assume moderate to substantial incidence of disease in all our settings. Therefore, risk was defined as large-scale, uncontrolled community transmission. When widespread vaccination has been achieved in our settings and/or when there are other indications of lower prevalence of disease in our sites, we may adjust our risk levels accordingly.

We assessed each HAPIN data collection activity among each group of participants (pregnant woman /new mother, infant, or non-pregnant older adult woman) because the risks may vary with each participant group. Data collection activities were graded and agreed upon by our team of scientists. Local site investigators were asked to report perceived concerns by staff and participants in their communities. Risk factors and definitions were presented to the HAPIN steering committee, which met weekly, for feedback before adoption. Even with adoption by the steering committee, if local community risk factors at the sites did not allow continued trial activities, the activity was stopped until safety could be ensured. Standard Operating Procedures were developed for the resumption of study activities and included guidance on screening staff and participants for Covid-19 symptoms, transporting staff in project vehicles, cleaning equipment and surfaces, conducting home visits and health facility survelliance, and quarantining for suspected exposures to the virus. These documents are reviewed monthly by two assigned investigators on the trial to reflect they reflect the most up to date knowledge of transmission dynamics and local risk.

Evaluation of risk criteria for each procedure included the age of participant, location, required physical proximity, exposure time, aerosolization potential, and criteria for use of PPE (Table  1 ). Using these criteria we established a four level schedule that ranged from minimal to unacceptably high risk (Table  2 ). We then proceeded to assess each research activity according to the criteria outlined in Table 1 and assigned a risk level and appropriate PPE to each of these. We assessed research activities that included LPG fuel delivery, administration of tablet-based surveys (e.g. questionnaires asked of mothers about their children’s health), data downloads from environmental monitors, personal exposure assessment to household air pollution, biological sample collection (e.g. urine, nasal swabs, venous blood) and lab processing of biological samples in the field laboratories, clinical measures (e.g. newborn birth weight, lung ultrasound, blood pressure), observations in homes of pregnant women/new mothers, children, and vascular procedures in adults (Additional file 1 ).

Protective measures available in our settings were: a) where feasible, data collection was completed by telephone; b) where possible, face-to-face activities were conducted outside; c) when inside homes, clinics or offices, staff and participants minimized the number of people in the room; d) rigourous hygiene for staff, materials, equipment and surfaces were employed at all times; e) appropriate PPE was used based on the context and activity; f) under very high risk conditions, the visit or the procedure was suspended.

Using this assessment and taking necessary measures for protection, almost all of our research activities were deemed to pose potentially manageable risks. Biological sample collection spanned a range of assigned risk due to differences in participant-staff interaction. The activities with the highest level of risk were those that potentially aerosolize the virus during the procedure. For example, urine collection requires minimal contact (i.e., field workers instruct the participant to collect and store the urine sample until it can be retreived) resulting in low risk to both the participant and the study staff. However, dried blood spot collection from capillary blood draws from infants (who are unable to wear a mask and often cry during the procedure) could feasibly put field workers at high risk (examples of two procedures are provided in Table 1 ; all procedures are described in the Additional file 1 ). To illustrate Level 4 activities, we identified several activities that were not part of our protocol, but that could pose unmanageable risks (e.g. bronchoscopy, sputum inducting procedures, cardiopulmonary resusitation) for routine research in the pandemic context (Table 2 ).

Our risk assessment framework uses a four-level risk schedule that is flexible, allowing adjustment for changes to risk measures and definitions as new evidence emerges about virus transmission. The approach and risk assessment tool we present here can be adapted by other investigators who are assessing and managing the risk posed in their own research during the coronavirus pandemic. However, prior to the deployment of risk assessment tools such as ours, researchers, in association with community members, IRBs, DSMBs, and grant funders need to evaluate the importance of any activity related to the primary aims of a trial weighed against the associated risk of performing the research activity. Obviously, local health regulations related to mobility, home or clinic visits by researchers supersede any of these judgments.

The framework offers a way to systematically evaluate diverse research activities involving different disciplines using the same basic criteria and a scoring system to compare associated risk for a given procedure. It also provides clear guidance for field teams on the appropriate PPE and practices in the context of limited resource environments, and thus appropriately utilizes limited PPE where it may be scarce and expensive. Despite these strengths, there are limitations. Our framework does not make recommendations on whether or not to continue an activity – e.g. through an explict cost-benefit algorithm. Decisions on what research should be continued in the presence of risk also require a careful assessment of benefits. We chose to make the risk-benefit calculation and decisions regarding which activities to suspend an independent process from assessment of risk. In our context, an efficacy trial, we are in equipoise regarding the potential benefits of the intervention to participants. Thus, analysis of benefits can only be honestly assessed in terms of the potential benefit of a given activity to the integrity of the trial, not to trial participants as maybe the case for other kinds of clinical research. Among the criteria we used to examine potential benefits of risk in the HAPIN trial were whether or not the aim of any given procedure supports a primary, secondary or tertiary (exploratory) outcome of the trial protocol. This evaluation is made by the HAPIN Steering Committee.

Furthermore, we do not factor in specific local regulations into the matrix in an a priori fashion, and thus leave it to local investigators and study teams to adjust for these [ 9 ]. Because of this, our framework specifications may need to be adjusted to meet local institutional or government regulations regarding PPE or other safety practices. Finally, our framework is limited by the current evidence regarding transmission risk and should be reevaluated and updated as our understanding grows. Such updates will require evaluation by scientists who are up to date on the current literature and recommendations regarding transmission and appropriate PPE, and must be sensitive to changes in local practices. While the recently discovered variants of the SARS-COV-2 suggests higher transmission risk, we do not have experimental or observation evidence at this time that our framework should be significantly changed [ 10 ]. However, should evidence emerge that for example, cloth masks are less protective or residual survival of the virus on surfaces is greater, we would need to make changes to our protocols [ 11 ].

Of note, the most relevant existing framework we are aware of for resumption of research in the COVID-19 pandemic context is that published by Lumeng and colleagues designed for U.S. clinical research. Our framework was developed independently and for a different context, but their basic approach is similar to ours in that it provides for a high level set of principles, a tiered framework, and risk evaluation that includes factors such as duration and distance of contact between researchers and patients. Our framework adds a great detail to risk evaluation in more complex and varied environments, and outlines how these can apply to specific and diverse research tasks (See Additional file 1 : Tables 1–5). Our framework also differs from Lumeng et al’s in that we have not included an explict benefit analysis, as described in the preceding paragraphs.

This risk analysis takes place in the dynamic context of a global pandemic. We plan to reassess each activity using our tool at least monthly as more information about SARS-CoV-2 transmission and the local epidemics becomes available. While the pandemic has been disruptive to our research, we believe there may also be some benefits from the shift in some data collection methods. For example, collecting data via telephone instead of visiting in-person increases time use efficiency for staff and decreases the burden of household visits on participants. Costs are lower, with less fuel used to travel via truck or motorbike to distant participant homes. On the other hand, telephone surveys may introduce uncertainty, if questions are complex in nature and may lead to poor response rates or lower quality data [ 12 ]. We acknowledge that we have been able to resume study activities in some of our research sites, and attribute this to building relationships with participants over the past several years and the commitment of our local teams and collaborating institutions.

For researchers now facing the need to resume activities that may lead to risk of exposure to staff and participants, we offer the following advice. First, evaluate any scientific developments about risk of infection or severity of disease that might change the calculus fundamentally. Second, convene representatives of your research teams, IRB members, relevant patient groups, stakeholders, and infectious disease experts to evaluate research activities against our framework and risk schedule, and then adapt as necessary with broad input. Third, while the field, clinical and laboratory activities we presented (Tables 1-2, Additional file 1 ) may be similar in scope to other research activities, we have obviously not presented all of the potential scenarios. Research activities should be adapted to fit individual research needs, reviewed repeatedly by stakeholder groups until consensus is reached, and operationalized using Standard Operating Procedures for each activity stream.

Beyond the risk assessment tool we have outlined above, we offer the following brief description of how we deployed these rules for field teams that may have similar needs. At the beginning of the pandemic, we temporarily suspended all activities except for LPG fuel delivery until risk of the measurements could be assessed and procedures put into place to ensure safety. We continued collecting data by telephone when possible. When in-person contact was permitted by local authorities and local institutional IRBs, we used our framework to guide the appropriate protocols. If designated PPE was not available or could not be used properly at any time, we postponed the activity. Similarly, our rules required goggles or face shields for certain procedures, but participants (especially children) may find these terrifying, especially when combined with masks and gloves. In these situations, it may not be possible to complete the work as planned, and local staff had the autonomy and responsibility to decide whether any activity should proceed.

Finally, our guidance is based on expert opinion and has not been empirically verified at this time. Importantly, our framework does not substitute for the need for coordination and approval of IRBs when protocols are modified.

We are optimistic that by applying this systematic, procedure-specific approach to risk assessment for each research activity, we will minimize the disruption in our trial due to the pandemic and support the completion of our primary outcomes. Our framework can be applied to other field trials in low-resource settings to guide investigators in assessing the risk of each trial activity and implementing appropriate safety measures, where the level of risk is acceptable. While no activity in the current context is completely without risk of infection, utilizing a systematic approach is the optimal way to safeguard research activities, protect research staff and participants, and comply with the ethical obligations to those that have agreed to participate in trials, along with the communities and funders that have supported these efforts.

Availability of data and materials

Data sharing is not applicable to this article as no datasets were generated or analyzed during the current study.

Abbreviations

Severe acute respiratory syndrome coronavirus-2

Coronavirus disease 2019

Personal protective equipment

Household Air Pollution Intervention Network

Institutional Review Boards

Data and Safety Monitoring Board

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Acknowledgements

A multidisciplinary, independent Data and Safety Monitoring Board (DSMB) appointed by the National Heart, Lung, and Blood Institute (NHLBI) monitors the quality of the data and protects the safety of patients enrolled in the HAPIN trial. NHLBI DSMB: Nancy R. Cook, Sc.D.; Stephen Hecht, Ph.D.; Catherine Karr, M.D., Ph.D.; Katie H. Kavounis, M.P.H.; Dong-Yun Kim, Ph.D.; Joseph Millum, Ph.D.; Lora A. Reineck, M.D., M.S.; Nalini Sathiakumar, M.D., Dr.P.H.; Paul K. Whelton, M.D.; Gail G. Weinmann, M.D.

Program Coordination: Gail Rodgers, M.D., Bill & Melinda Gates Foundation; Claudia L. Thompson, Ph.D., National Institute of Environmental Health Science (NIEHS); Mark J. Parascandola, Ph.D., M.P.H., National Cancer Institute (NCI); Danuta M. Krotoski, Ph.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Joshua P. Rosenthal, Ph.D., Fogarty International Center (FIC); Conception R. Nierras, Ph.D., NIH Office of Strategic Coordination Common Fund; Antonello Punturieri, M.D., Ph.D. and Barry S. Schmetter, B.S., National Heart, Lung, and Blood Institute (NHLBI).

The findings and conclusions in this report are those of the authors and do not necessarily represent the official position of the U.S. National Institutes of Health or Department of Health and Human Services.

HAPIN Investigators: Vigneswari Aravindalochanan, Kalpana Balakrishnan, Dana Boyd Barr, Vanessa Burrowes, Devan Campbell, Julia McPeek Campbell, Eduardo Canuz, Adly Castañaza, Howard Chang, William Checkley, Yunyun Chen, Marilú Chiang, Maggie L. Clark, Thomas Clasen, Rachel Craik, Mary Crocker, Victor Dávila-Román, Lisa de las Fuentes, Oscar De Léon, Anaité Diaz-Artiga, Ephrem Dusabimana, Lisa Elon, Juan Gabriel Espinoza, Irma Sayury Pineda Fuentes, Sarada Garg, Dina Goodman, Savannah Gupton, Meghan Hardison, Stella Hartinger, Steven A. Harvey, Mayari Hengstermann, Phabiola Herrera, Shakir Hossen, Penelope Howards, Lindsay Jaacks, Shirin Jabbarzadeh, Michael A. Johnson, Abigail Jones, Katherine Kearns, Miles Kirby, Jacob Kremer, Margaret Laws, Patricia M. Lenzen, Jiawen Liao, Amy Lovvorn, Fiona Majorin, Eric McCollum, John P. McCracken, Rachel M. Meyers, J. Jaime Miranda, Erick Mollinedo, Lawrence Moulton, Krishnendu Mukhopadhyay, Luke Naeher, Abidan Nambajimana, Florien Ndagijimana, Azhar Nizam, Jean de Dieu Ntivuguruzwa, Aris Papageorghiou, Jennifer Peel, Ricardo Piedrahita, Ajay Pillarisetti, Naveen Puttaswamy, Elisa Puzzolo, Ashlinn Quinn, Sarah Rajkumar, Usha Ramakrishnan, Davis Reardon, Ghislaine Rosa, Joshua Rosenthal, P. Barry Ryan, Zoe Sakas, Sankar Sambandam, Jeremy Sarnat, Suzanne Simkovich, Sheela Sinharoy, Kirk R. Smith, Kyle Steenland, Damien Swearing, Gurusamy Thangavel, Lisa M. Thompson, Ashley K. Toenjes, Lindsay Underhill, Jean Damascene Uwizeyimana, Viviane Valdes, Amit Verma, Lance Waller, Megan Warnock, Kendra Williams, Wenlu Ye, Bonnie N. Young.

The Healthcare Delivery Network at Medstar Health Research Institute supported the submission of this manuscript as Suzanne M. Simkovich transferred her affiliation.

Role of study sponsor

Program officials from all of the above listed organizations participated in regular conference calls, made recommendations about study design and participated in final decision-making on the trial study protocol for the overall HAPIN trial; program officials from the National Heart, Lung and Blood Institute, National Institute of Environmental Health Sciences, and the Bill & Melinda Gates Foundation commented on drafts of this substudy; however, no program officials had a role in the writing of this report or decision to submit it for publication. The corresponding authors share final responsibility for the decision to submit for publication.

This study is funded by the U.S. National Institutes of Health (cooperative agreement 1UM1HL134590) in collaboration with the Bill & Melinda Gates Foundation (OPP1131279). Participating NIH organizations include the National Heart, Lung and Blood Institute, National Institute of Environmental Health Sciences, National Cancer Institute, National Institute of Child Health and Human Development, Fogarty International Center, and the NIH Common Fund. Suzanne M. Simkovich was supported by funding from the National Heart, Lung and Blood Institute U., the National Heart, Lung, and Blood Institute 1F32HL143909–01, the National Heart, Lung, and Blood Institute K12HL137942. Lindsay J. Underhill and Kendra Williams were supported by Research Training Grant D43TW009340 (MPIs: Buekens, Checkley, Chi, Kondwani) funded by United States National Institutes of Health through the following Institutes and Centers: Fogarty International Center, National Institute of Neurological Disorders and Stroke, National Institute of Mental Health, National Heart, Lung, and Blood Institute and the National Institute of Environmental Health Sciences along with the National Heart, Lung, and Blood Institute 1F32HL143909–01.

Author information

Authors and affiliations.

Division of Pulmonary and Critical Care, School of Medicine, Johns Hopkins University, Baltimore, USA

Suzanne M. Simkovich, William Checkley, Lindsay J. Underhill & Kendra N. Williams

Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, USA

Suzanne M. Simkovich, William Checkley, Steven Harvey, Lindsay J. Underhill & Kendra N. Williams

MedStar Health Research Institute, Hyattsville, USA

Suzanne M. Simkovich

Nell Hodgson Woodruff School of Nursing, Emory University, Atlanta, USA

Lisa M. Thompson

Department of Environmental and Radiological Health Sciences, Colorado State University, Fort Collins, USA

Maggie L. Clark, Jennifer L. Peel & Bonnie N. Young

Department of Environmental Health Engineering, ICMR Center for Advanced Research on Air Quality, Climate and Health, Sri Ramachandra Institute for Higher Education and Research (Deemed University), Chennai, India

Kalpana Balakrishnan

A.B. PRISMA, San Miguel, Peru

Alejandra Bussalleu

CLIMA – Latin American Center of Excellence in Climate Change and Health; and Intercultural Citizenship and Indigenous Health Unit, Faculty of Public Health and Administration, Universidad Peruana Cayetano Heredia, Lima, Peru

Gangarosa Department of Environmental Health, Rollins School of Public Health, Emory University, Atlanta, USA

Thomas Clasen & Amy Lovvorn

Cardiovascular Division, Department of Medicine, Washington University School of Medicine, St. Louis, USA

Victor G. Davila-Roman & Lisa de las Fuentes

Center for Health Studies, Universidad del Valle de Guatemala, Guatemala City, Guatemala

Anaite Diaz-Artiga

Eagle Research Center, Kigali, Rwanda

Ephrem Dusabimana

Department of International Health, Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University, Baltimore, USA

Steven Harvey

Department of Global Health and Population, Harvard T.H. Chan School of Public Health, Boston, MA, USA

Miles A. Kirby

Global Program for Respiratory Sciences, Eudowood Division of Pediatric Respiratory Sciences, Department of Pediatrics, School of Medicine, Johns Hopkins University, Baltimore, USA

Eric D. McCollum

Department of Environmental Health Science, College of Public Health, University of Georgia, Athens, USA

Erick E. Mollinedo

Division of International Epidemiology and Population Studies, Fogarty International Center, National Institutes of Health, Bethesda, USA

Ashlinn Quinn & Joshua Rosenthal

Faculty of Infectious and Tropical Diseases, London School of Hygiene and Tropical Medicine, London, UK

Ghislaine Rosa

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• Vigneswari Aravindalochanan
• , Kalpana Balakrishnan
• , Dana Boyd Barr
• , Vanessa Burrowes
• , Devan Campbell
• , Julia Mc Peek Campbell
• , Eduardo Canuz
• , Adly Castañaza
• , Howard Chang
• , William Checkley
• , Yunyun Chen
• , Marilú Chiang
• , Maggie L. Clark
• , Thomas Clasen
• , Rachel Craik
• , Mary Crocker
• , Victor Dávila-Román
• , Lisa de las Fuentes
• , Oscar De Léon
• , Anaité Diaz-Artiga
• , Ephrem Dusabimana
• , Lisa Elon
• , Juan Gabriel Espinoza
• , Irma Sayury Pineda Fuentes
• , Sarada Garg
• , Dina Goodman
• , Savannah Gupton
• , Meghan Hardison
• , Stella Hartinger
• , Steven A. Harvey
• , Mayari Hengstermann
• , Phabiola Herrera
• , Shakir Hossen
• , Penelope Howards
• , Lindsay Jaacks
• , Shirin Jabbarzadeh
• , Michael A. Johnson
• , Abigail Jones
• , Katherine Kearns
• , Miles Kirby
• , Jacob Kremer
• , Margaret Laws
• , Patricia M. Lenzen
• , Jiawen Liao
• , Amy Lovvorn
• , Fiona Majorin
• , Eric McCollum
• , John P. McCracken
• , Rachel M. Meyers
• , J. Jaime Miranda
• , Erick Mollinedo
• , Lawrence Moulton
• , Krishnendu Mukhopadhyay
• , Luke Naeher
• , Abidan Nambajimana
• , Florien Ndagijimana
• , Azhar Nizam
• , Jean de Dieu Ntivuguruzwa
• , Aris Papageorghiou
• , Jennifer Peel
• , Ricardo Piedrahita
• , Ajay Pillarisetti
• , Naveen Puttaswamy
• , Elisa Puzzolo
• , Ashlinn Quinn
• , Sarah Rajkumar
• , Usha Ramakrishnan
• , Davis Reardon
• , Ghislaine Rosa
• , Joshua Rosenthal
• , P. Barry Ryan
• , Zoe Sakas
• , Sankar Sambandam
• , Jeremy Sarnat
• , Suzanne Simkovich
• , Sheela Sinharoy
• , Kirk R. Smith
• , Kyle Steenland
• , Damien Swearing
• , Gurusamy Thangavel
• , Lisa M. Thompson
• , Ashley K. Toenjes
• , Lindsay Underhill
• , Jean Damascene Uwizeyimana
• , Viviane Valdes
• , Amit Verma
• , Lance Waller
• , Megan Warnock
• , Kendra Williams
•  & Bonnie N. Young

Contributions

SS & JR conceptualized design of the tool, built the tool, completed the risk assessment of each activity, provided scientific input to assess each activity and wrote the manuscript. LT and MC built the tool, provided scientific input to assess each activity and participated in the writing of the manuscript.TC, WC, AL, JP oversaw the trial’s decisions in risk and benefit and the building of the risk assessment tool and provided comments to the writing of the manuscript. KB, AB, WC, TC, VDR, ADA, LF, SH, MK, AL, EM, EM, ED, JP, AQ, GR, provided scientific input into the design of the tool, reviewed and provided input on each activity, and provided comments to the writing of the manuscript. LU, KW, BY provided scientific input into the design of the tool, completed the assessment of activities, provided scientific input on the tool and provided comments to the writing of the manuscript. All Authors have reviewed and approved the final manuscript.

Corresponding author

Correspondence to Suzanne M. Simkovich .

Ethics declarations

Ethics approval and consent to participate.

This project is a component of a larger clinical trial. The overall study protocol was reviewed and approved by institutional review boards (IRBs) or Ethics Committees at Emory University (00089799), Johns Hopkins University (00007403), Sri Ramachandra Institute of Higher Education and Research (IEC-N1/16/JUL/54/49) and the Indian Council of Medical Research – Health Ministry Screening Committee (5/8/4–30/(Env)/Indo-US/2016-NCD-I), Universidad del Valle de Guatemala (146–08-2016/11–2016) and Guatemalan Ministry of Health National Ethics Committee (11–2016), A.B. PRISMA (CE29841.17), the London School of Hygiene and Tropical Medicine (11664–5) and the Rwandan National Ethics Committee (No.357/RNEC/2018), and Washington University in St. Louis (201611159). Written consent was obtained from all participants.

Consent for publication

Not applicable.

Competing interests

No authors have competing interests.

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Publisher’s note.

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Suzanne M. Simkovich - Change in institution

Ashlinn Quinn and Joshua Rosenthal - the views expressed in this publication are those of the investigators and do not reflect official statements or policy of the National Institutes of Health.

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Simkovich, S.M., Thompson, L.M., Clark, M.L. et al. A risk assessment tool for resumption of research activities during the COVID-19 pandemic for field trials in low resource settings. BMC Med Res Methodol 21 , 68 (2021). https://doi.org/10.1186/s12874-021-01232-x

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DOI : https://doi.org/10.1186/s12874-021-01232-x

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• Risk assessment

BMC Medical Research Methodology

ISSN: 1471-2288

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A Risk Assessment Tool for Resumption of Research Activities During the COVID-19 Pandemic

Affiliations.

• 1 MedStar Health Research Institute.
• 2 Emory University Nell Hodgson Woodruff School of Nursing.
• 3 Colorado State University.
• 4 Sri Ramachandra Institute for Higher Education and Research.
• 5 Universidad Peruana Cayetano Heredia.
• 6 Johns Hopkins: Johns Hopkins University.
• 7 Emory University School of Public Health.
• 8 Washington University In St Louis: Washington University in Saint Louis.
• 9 Universidad del Valle de Guatemala.
• 10 Johns Hopkins University.
• 11 Harvard University.
• 12 Emory University.
• 13 National Institutes of Health.
• 14 London School of Hygiene & Tropical Medicine.
• PMID: 33200126
• PMCID: PMC7668754
• DOI: 10.21203/rs.3.rs-103997/v1

Rationale: The spread of severe acute respiratory syndrome coronavirus-2 has suspended many non-COVID-19 related research activities. Where restarting research activities is permitted, investigators need to evaluate the risks and benefits of resuming data collection and adapt procedures to minimize risk.

Objectives: In the context of the multicountry Household Air Pollution Intervention (HAPIN) trial, we developed a framework to assess the risk of each trial activity and to guide protective measures. Our goal is to maximize integrity of reseach aims while minimizing infection risk based on the latest understanding of the virus.

Methods: We drew on a combination of expert consultations, risk assessment frameworks, institutional guidance and literature to develop our framework. We then systematically graded clinical, behavioral, laboratory and field environmental health research activities in four countries for both adult and child subjects using this framework.

Results: Our framework assesses risk based on staff proximity to the participant, exposure time between staff and participants, and potential aerosolization while performing the activity. One of of four risk levels, from minimal to unacceptable, is assigned and guidance on protective measures is provided. Those activities which can potentially aerosolize the virus are deemed the highest risk.

Conclusions: By applying a systematic, procedure-specific approach to risk assessment for each trial activity, we can compare trial activities using the same criteria. This approach allows us to protect our participants and research team and to uphold our ability to deliver on the research commitments we have made to our participants, local communities, and funders. The trial is registered with clinicaltrials.gov ( NCT02944682 ).

Publication types

Associated data.

• ClinicalTrials.gov/NCT02944682

Grants and funding

• F32 HL143909/HL/NHLBI NIH HHS/United States
• K12 HL137942/HL/NHLBI NIH HHS/United States
• D43 TW009340/TW/FIC NIH HHS/United States
• UM1 HL134590/HL/NHLBI NIH HHS/United States
• T32 HL007534/HL/NHLBI NIH HHS/United States

Understanding Potential Risks for Human Subjects Research

As part of their ethical duty to participants, all researchers are required to properly identify, minimize, and disclose any potential harm or discomforts that may come to participants. These harms and discomforts are labeled as “ risks, ” and should be minimized, according to the beneficence principle of the Belmont Report . Any risks that may potentially befall participants must be disclosed in the informed consent , and participants should be given the choice of whether or not to participate in research. 

Additional risks may also be encountered in light of a catastrophic event (e.g., a natural disaster, epidemic, terrorist attack, pandemic, etc.). During these times, researchers with active protocols must review their study activities to identify and mitigate any new risk. For example, prior to the COVID-19 pandemic and depending on the topic, TC IRB typically considered in-person surveys with adults competent to consent as low risk. Under COVID-19 circumstances, however, studies with in-person components are now reviewed as higher risk, as person-to-person exposure is the most frequent route of transmission for infectious viruses. The IRB is required to assess the level of risk involved in a research study when making a determination for review requirements. Some items factoring into the IRB’s risk assessment include possible risk to a subject’s psychological wellbeing, or the risk to a subject if their confidentiality is compromised. The more risk involved in a study, the higher the level of review and the more human subject protections required by the IRB.

Examples of Potential Risks & Suggestions for Mitigation

Reviewing potential risks to participants requires a knowledge of various types of harm or discomfort that participants may encounter. The Teachers College research community is largely composed of behavioral and social researchers. The following examples and suggestions for minimizing risks are likely to be encountered in behavioral science research, though they may also extend to biomedical and other types of research as well. 

Loss of Time : Researchers are required to include the estimated time of each study activity and the total time of completion on the informed consent (parent permission or assent form). Researchers should: 

• Estimate study completion time based on pilot tests.
• Consider the reading level of participants (e.g., 3rd grade readers vs. post-secondary students) when calculating the time necessary to complete the study.
• Reasonably overestimate times to account for participants that may take longer.
• Prepare for potential time delays when using online software (e.g., Zoom ) or introducing new activities.

Traumatic Events: Recalling traumatic or distressing events can be uncomfortable, and in some cases, harmful to an individual.  Traumatic events are defined as events that are shocking, scary, or dangerous (e.g., natural disasters, acts of violence, accidents, etc.). While it is not always possible to identify what types of questions may trigger participants, researchers should identify and disclose questions or activities pertaining to traumatic events. Researchers should: 

• Disclose any topics, study activities, or questions that may be triggering in the informed consent. For example, if the study includes questions about a traumatic event (e.g., 9/11), provide a trigger warning such as “The next section will include questions that may be uncomfortable to you. This study is voluntary. You can choose to stop the study at any time or skip any question.” 
• Monitor the participant during each study activity and after, if possible. While the participant may appear fine during a study,  recalling traumatic events may lead to flashbacks, insomnia, trouble concentrating, or higher levels of anxiety, sadness, or anger for a prolonged period of time.
• Provide participants with a list of community resources, or offer free counseling services (if appropriate), should the need arise.
• Consider options such as recruiting a trained professional to be available to help debrief the participants if they start to experience symptoms of distress.

Unwanted Stimuli: Exposure to unwanted or distressing stimuli during a study’s activities may bring harm and discomfort. Participants should not be exposed to distressing stimuli (e.g., pornography, smoking, suicide) without first providing their clear consent. Researchers should:

• Know the risks associated with exposing participants to unwanted stimuli (e.g., increased sadness or irritability), and implement additional safeguards throughout their study, such as debriefing participants after the study activities are finished.
• Refrain from exposing high-risk groups to unwanted stimuli. For example, study activities including heavy drinking or intoxication should screen out recovering substance users.  

Labeling: Participants unfamiliar with clinical terminology may begin to identify with disorders or personalities outlined in study measures. For example, someone taking a scale labeled “Depression Scale” may begin to identify as having depression without receiving a clinical diagnosis. Researchers should:

• Reduce participant confusion by appropriately and clearly naming scales or removing measure names altogether. 
• Examine tiles of studies for potential bias and risk to participants.

Environmental Stimuli: Environmental stimuli, such as the research location, building layout, lighting, or external noise, is not always considered in the research design. However, some stimuli may be triggering for participants, and should be eliminated, if possible. Researchers should:

• Examine their research space for any environmental allergens or health issues, such as dust and flickering lights, prior to inviting participants.
• Remain mindful of possible food allergies (e.g., nuts, shellfish, gluten) when serving snacks or refreshments.
• Ensure that the space is safe, secure, hygienic , and, if applicable, private.
• Review the CDC's detailed instructions on how to clean and disinfect workspaces, along with their list of EPA-approved disinfectants .

Minor Emotional Risk: Typical common, but minor, risks include mental fatigue, embarrassment, discomfort, or frustration. Researchers should:

• Review their study activities from the perspective of the participant in order to determine if these emotions might be encountered. For example, a 5-minute survey on personal food preferences is unlikely to cause frustration. However, a study activity in which participants must solve complex mathematical equations in front of peers may cause embarrassment or frustration. 
• Always disclose any anticipated distressing emotions in the consent form.

Participant Relationships: Putting strain on participants’ relationships (e.g., causing a fight between a dating couple) will likely cause harm or discomfort to a participant. Researchers should: 

• Disclose study activities in the consent form that may cause relationship distress.
• Distinguish between study activities that may cause relationship distress  (e.g., this study will examine household spending habits between partners) from unintentional relationship distress perpetuated in error by the researcher. In the latter’s case, the researcher should gauge the situation and take steps to ensure respect, participant autonomy, and care.

Exercise & Repetitive Movements : Studies involving exercise or movement have an inherent risk of physical injury to the participants. Researchers should:

• Disclose all activities at the beginning of the study that may cause physical discomfort.
• Evaluate or discuss the participants’ physical health and ability based on the study activity (e.g., able to lift 20 pounds without assistance).
• Gauge the health of the participant to engage in the activities. For example, does the participant have any underlying health conditions that might impact their ability to participate? (e.g., a study requiring intense cardio exertion might want to screen for asthmatic participants).
• Disclose health risks on the consent form.

Personal Information: A sking questions about private information such as income, health habits, illegal substance use, etc. may be distressing for participants. Inclusion of these types of questions should be clearly justified to the IRB. Researchers should:

• Clarify confidentiality policies.
• Disclose what identifiers may be disclosed, or are at risk of disclosure (e.g., during focus group sessions, researchers cannot guarantee confidentiality).
• Review  Certificates of Confidentiality (CoC) for human subjects, if applicable.

Viral Illnesses, Spreads, or Pandemics: With the COVID-19 pandemic, person-to-person contact is the most frequent route of viral transmission. Researchers with in-person components in their study must evaluate study activities for points of contact. Exposure is at its highest when people are within approximately 6 feet of one another, and in close contact for 15 minutes or more. Shared spaces, equipment, and surfaces (e.g., office keyboards, writing utensils, etc.) can also be contaminated. To reduce the risk of infection, researchers should:

• Wash hands with soap and water for 20 seconds. If soap and water are not available, use a hand sanitizer that contains at least 60% alcohol.
• Avoid touching one’s face.
• Use face coverings when around other people.
• Cover coughs and sneezes.
• Throw used tissues in the trash.
• Practice social distancing, if possible.
• Clean and disinfect high-touch surfaces daily. This may include tables, doorknobs, light switches, countertops, handles, desks, phones, keyboards, toilets, faucets, and sinks.
• Restrict in-person interactions to ventilated areas, or outside when possible.
• Remain vigilant about taking the steps that reduce exposure.

Requirements for Mitigating Research Risks

When assessing risk and benefits in a study, the IRB can support researchers in determining if a risk is justifiable or should be removed. Generally, risks to participants must be minimized, and any risks in the study should be reasonable when compared to the benefits of the study. 

The IRB also requires that each individual participant provides their informed consent. All consent must be documented and available for review if requested. If a participant is unable to provide their consent (e.g., a minor), their guardian must provide consent, and the participant’s assent should be sought. If a participant is likely to be vulnerable to coercion (e.g., prisoners, cognitively impaired persons, etc.), additional safeguards must be outlined in the IRB application. Additionally, researchers must justify the rationale for conducting their study with vulnerable populations as opposed to general populations (e.g., the study provides an intervention which fills a need for that specific population). For sample consent and application language, please visit our  TC IRB Submission Document Templates & Samples guide.

In the informed consent, the privacy and confidentiality of the participants must be appropriately documented. TC IRB recommends that all data be  de-identified prior to the start of analysis. Finally, the research plan must make provisions for the secure collection and monitoring of data (visit our Data Sharing, Requests, & Encryption  for more information). TC IRB has worked closely with TC Information Technologies (IT) to support researchers working remotely with limited resources and technological capabilities. TC IT should be consulted as the first point of contact if data cannot be secured to the standards outlined in the data security plan.

For COVID-19 related information, risks, and preparation please visit  here.

Institutional Review Board

Address: Russell Hall, Room 13

* Phone: 212-678-4105 * Email:   [email protected]

Appointments are available by request . Make sure to have your IRB protocol number (e.g., 19-011) available.  If you are unable to access any of the downloadable resources, please contact  OASID via email [email protected] .

A complete guide to the risk assessment process

Lucid Content

Reading time: about 7 min

Mark Zuckerberg, the founder of Facebook, once said, “The biggest risk is not taking any risk. In a world that's changing really quickly, the only strategy that is guaranteed to fail is not taking risks.”

While this advice isn't new, we think you’ll agree that there are some risks your company doesn’t want to take: Risks that put the health and well-being of your employees in danger.

These are risks that aren’t worth taking. But it’s not always clear what actions, policies, or procedures are high-risk. 

That’s where a risk assessment comes in.

With a risk assessment, companies can identify and prepare for potential risks in order to avoid catastrophic consequences down the road and keep their personnel safe.

What is risk assessment?

During the risk assessment process, employers review and evaluate their organizations to:

• Identify processes and situations that may cause harm, particularly to people (hazard identification).
• Determine how likely it is that each hazard will occur and how severe the consequences would be (risk analysis and evaluation).
• Decide what steps the organization can take to stop these hazards from occurring or to control the risk when the hazard can't be eliminated (risk control).

It’s important to note the difference between hazards and risks. A hazard is anything that can cause harm , including work accidents, emergency situations, toxic chemicals, employee conflicts, stress, and more. A risk, on the other hand, is the chance that a hazard will cause harm . As part of your risk assessment plan, you will first identify potential hazards and then calculate the risk or likelihood of those hazards occurring.

The goal of a risk assessment will vary across industries, but overall, the goal is to help organizations prepare for and combat risk. Other goals include:

• Providing an analysis of possible threats
• Preventing injuries or illnesses
• Meeting legal requirements
• Creating awareness about hazards and risk
• Creating an accurate inventory of available assets
• Justifying the costs of managing risks
• Determining the budget to remediate risks
• Understanding the return on investment

Businesses should perform a risk assessment before introducing new processes or activities, before introducing changes to existing processes or activities (such as changing machinery), or when the company identifies a new hazard.

The steps used in risk assessment form an integral part of your organization’s health and safety management plan and ensure that your organization is prepared to handle any risk.  

Preparing for your risk assessment 

Before you start the risk management process, you should determine the scope of the assessment, necessary resources, stakeholders involved, and laws and regulations that you’ll need to follow. 

Scope: Define the processes, activities, functions, and physical locations included within your risk assessment. The scope of your assessment impacts the time and resources you will need to complete it, so it’s important to clearly outline what is included (and what isn’t) to accurately plan and budget. 

Resources : What resources will you need to conduct the risk assessment? This includes the time, personnel, and financial resources required to develop, implement, and manage the risk assessment. 

Stakeholders: Who is involved in the risk assessment? In addition to senior leaders that need to be kept in the loop, you’ll also need to organize an assessment team. Designate who will fill key roles such as risk manager, assessment team leader, risk assessors, and any subject matter experts. 

Laws and regulations: Different industries will have specific regulations and legal requirements governing risk and work hazards. For instance, the Occupational Safety and Health Administration (OSHA) sets and enforces working condition standards for most private and public sectors. Plan your assessment with these regulations in mind so you can ensure your organization is compliant. 

5 steps in the risk assessment process

Once you've planned and allocated the necessary resources, you can begin the risk assessment process.

Proceed with these five steps.

1. Identify the hazards

The first step to creating your risk assessment is determining what hazards your employees and your business face, including:

• Natural disasters (flooding, tornadoes, hurricanes, earthquakes, fire, etc.)
• Biological hazards (pandemic diseases, foodborne illnesses, etc.)
• Workplace accidents (slips and trips, transportation accidents, structural failure, mechanical breakdowns, etc.)
• Intentional acts (labor strikes, demonstrations, bomb threats, robbery, arson, etc.)
• Technological hazards (lost Internet connection, power outage, etc.)
• Chemical hazards (asbestos, cleaning fluids, etc.)
• Mental hazards (excess workload, bullying, etc.)
• Interruptions in the supply chain

Take a look around your workplace and see what processes or activities could potentially harm your organization. Include all aspects of work, including remote workers and non-routine activities such as repair and maintenance. You should also look at accident/incident reports to determine what hazards have impacted your company in the past.

Use Lucidchart to break down tasks into potential hazards and assets at risk—try our free template below.

2. Determine who might be harmed and how

As you look around your organization, think about how your employees could be harmed by business activities or external factors. For every hazard that you identify in step one, think about who will be harmed should the hazard take place.

3. Evaluate the risks and take precautions

Now that you have gathered a list of potential hazards, you need to consider how likely it is that the hazard will occur and how severe the consequences will be if that hazard occurs. This evaluation will help you determine where you should reduce the level of risk and which hazards you should prioritize first.

Later in this article, you'll learn how you can create a risk assessment chart to help you through this process.

4. Record your findings

If you have more than five employees in your office, you are required by law to write down your risk assessment process. Your plan should include the hazards you’ve found, the people they affect, and how you plan to mitigate them. The record—or the risk assessment plan—should show that you:

• Conducted a proper check of your workspace
• Determined who would be affected
• Controlled and dealt with obvious hazards
• Initiated precautions to keep risks low
• Kept your staff involved in the process

5. Review your assessment and update if necessary

Your workplace is always changing, so the risks to your organization change as well. As new equipment, processes, and people are introduced, each brings the risk of a new hazard. Continually review and update your risk assessment process to stay on top of these new hazards.

How to create a risk assessment chart

Even though you need to be aware of the risks facing your organization, you shouldn’t try to fix all of them at once—risk mitigation can get expensive and can stretch your resources. Instead, prioritize risks to focus your time and effort on preventing the most important hazards. To help you prioritize your risks, create a risk assessment chart.

The risk assessment chart is based on the principle that a risk has two primary dimensions: probability and impact, each represented on one axis of the chart. You can use these two measures to plot risks on the chart, which allows you to determine priority and resource allocation.

Be prepared for anything

By applying the risk assessment steps mentioned above, you can manage any potential risk to your business. Get prepared with your risk assessment plan—take the time to look for the hazards facing your business and figure out how to manage them.

Now it's time to create your own risk management process, here are five steps to get you started.

About Lucidchart

Lucidchart, a cloud-based intelligent diagramming application, is a core component of Lucid Software's Visual Collaboration Suite. This intuitive, cloud-based solution empowers teams to collaborate in real-time to build flowcharts, mockups, UML diagrams, customer journey maps, and more. Lucidchart propels teams forward to build the future faster. Lucid is proud to serve top businesses around the world, including customers such as Google, GE, and NBC Universal, and 99% of the Fortune 500. Lucid partners with industry leaders, including Google, Atlassian, and Microsoft. Since its founding, Lucid has received numerous awards for its products, business, and workplace culture. For more information, visit lucidchart.com.

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The Essentials of Effective Project Risk Assessments

By Kate Eby | September 19, 2022

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Performing risk assessments is vital to a project’s success. We’ve gathered tips from experts on doing effective risk assessments and compiled a free, downloadable risk assessment starter kit. 

Included on this page, you’ll find details on the five primary elements of risk , a comprehensive step-by-step process for assessing risk , tips on creating a risk assessment report , and editable templates and checklists to help you perform your own risk assessments.

What Is a Project Risk Assessment?

A project risk assessment is a formal effort to identify and analyze risks that a project faces. First, teams identify all possible project risks. Next, they determine the likelihood and potential impact of each risk.

During a project risk assessment, teams analyze both positive and negative risks. Negative risks are events that can derail a project or significantly hurt its chances of success. Negative risks become more dangerous when teams haven’t identified them or created a plan to deal with them.

A project risk assessment also looks at positive risks. Also called opportunities, positive risks are events that stand to benefit the project or organization. Your project team should assess those risks so they can seize on opportunities when they arise.

Your team will want to perform a project risk assessment before the project begins. They should also continually monitor for risks and update the assessment throughout the life of the project.

Some experts use the term project risk analysis to describe a project risk assessment. However, a risk analysis typically refers to the more detailed analysis of a single risk within your broader risk assessment. For expert tips and information, see this comprehensive guide to performing a project risk analysis. 

Project risk assessments are an important part of project risk management. Learn more from experts about best practices in this article on project risk management . For even more tips and resources, see this guide to creating a project risk management plan .

How Do You Assess Risk in a Project?

Teams begin project risk assessments by brainstorming possible project risks. Avoid missing important risks by reviewing events from similar past projects. Finally, analyze each risk to understand its time frame, probability, factors, and impact.  

Your team should also gather input from stakeholders and others who might have thoughts on possible risks. 

In general terms, consider these five important elements when analyzing risks:

• Risk Event: Identify circumstances or events that might have an impact on your project. 
• Risk Time Frame: Determine when these events are most likely to happen. This might mean when they happen in the lifecycle of a project or during a sales season or calendar year. 
• Probability: Estimate the likelihood of an event happening. 
• Impact: Determine the impact on the project and your organization if the event happens. 
• Factors: Determine the events that might happen before a risk event or that might trigger the event.

Project Risk Assessment Tools

Project leaders can use various tools and methodologies to help measure risks. One option is a failure mode and effects analysis. Other options include a finite element analysis or a factor analysis and information risk.

These are some common risk assessment tools:

• Process Steps: Identify all steps in a process.
• Potential Problems: Identify what could go wrong with each step.
• Problem Sources: Identify the causes of the problem.
• Potential Consequences: Identify the consequences of the problem or failure.
• Solutions: Identify ways to prevent the problem from happening.
• Finite Element Analysis (FEA): This is a computerized method for simulating and analyzing the forces on a structure and the ways that a structure could break. The method can account for many, sometimes thousands, of elements. Computer analysis then determines how each of those elements works and how often the elements won’t work. The analysis for each element is then added together to determine all possible failures and the rate of failure for the entire product.
• Factor Analysis of Information Risk (FAIR): This framework helps teams analyze risks to information data or cybersecurity risk.

How to Conduct a Project Risk Assessment

The project manager and team members will want to continually perform risk assessments for a project. Doing good risk assessments involves a number of steps. These steps include identifying all possible risks and assessing the probability of each.

Most importantly, team members must fully explore and assess all possible risks, including risks that at first might not be obvious.

“The best thing that a risk assessment process can do for any project, over time, is to be a way of bringing unrecognized assumptions to light,” says Mike Wills , a certified mentor and coach and an assistant professor at Embry-Riddle Aeronautical University’s College of Business. “We carry so many assumptions without realizing how they constrain our thinking.”

Steps in a Project Risk Assessment

Experts recommend several important steps in an effective project risk assessment. These steps include identifying potential risks, assessing their possible impact, and formulating a plan to prevent or respond to those risks.

Here are 10 important steps in a project risk assessment:

Step 1: Identify Potential Risks

Bring your team together to identify all potential risks to your project. Here are some common ways to help identify risks, with tips from experts:

• Review Documents: Review all documents associated with the project.
• Consider Industry-Specific Risks: Use risk prompt lists for your industry. Risk prompt lists are broad categories of risks, such as environmental or legal, that can occur in a project.
• Revisit Previous Projects: Use checklists from similar projects your organization has done in the past. 

• “What I like to do for specific types of projects is put together a checklist, a taxonomy of old risks that you've identified in other projects from lessons learned,” says Wendy Romeu, President and CEO of Alluvionic . “Say you have a software development program. You would pull up your template that includes all the risks that you realized in other projects and go through that list of questions. Then you would ask: ‘Do these risks apply to our project?’ That's kind of a starting point.” “You do that with your core project team,” Romeu says, “and it gets their juices flowing.” Learn more about properly assessing lessons learned at the end of a project in this comprehensive guide to project management lessons learned .
• Consult Experts: Conduct interviews with experts within and, in some cases, outside your organization.
• Brainstorm: Brainstorm ideas with your team. “The best scenario, which doesn't usually happen, is the whole team comes together and identifies the risks,” says Romeu.
• Stick to Major Risks: Don’t try to identify an unrealistic or unwieldy number of risks. “You want to identify possible risks, but you want to keep the numbers manageable,” says Wills. “The more risks you identify, the longer you spend analyzing them. And the longer you’re in analysis, the fewer decisions you make.”
• Look for Positive Risks: Identify both positive risks and negative ones. It’s easy to forget that risks aren’t all negative. There can be unexpected positive events as well. Some people call these opportunities , but in a risk assessment, experts call them positive risks. 

• “A risk is a future event that has a likelihood of occurrence and an impact,” says Alan Zucker, founding principal of Project Management Essentials , who has more than two decades of experience managing projects in Fortune 100 companies. “Risks can both be opportunities — good things — and threats. Most people, when they think about risk assessment, they always think about the negatives. I really try to stress on people to think about the opportunities as well.” Opportunities, or positive risks, might include your team doing great work on a project and a client wanting the team to do more work. Positive risks might include a project moving forward more quickly than planned or costing less money than planned. You’ll want to know how to respond in those situations, Zucker says. Learn more about project risk identification and find more tips from experts in this guide to project risk identification .

Step 2: Determine the Probability of Each Risk

After your team has identified possible risks, you will want to determine the probability of each risk happening. Your team can make educated guesses using some of the same methods it used to identify those risks.

Determine the probability of each identified risk with these tactics:

• Brainstorm with your team.
• Interview experts.
• Review similar past projects.
• Review other projects in the same industry.

Step 3: Determine the Impact of Each Risk

Your team will then determine the impact of each risk should it occur. Would the risk stop the project entirely or stop the development of a product? Or would the risk occurring have a relatively minor impact?

Assessing impact is important because if it’s a positive risk, Romeu says, “You want to make sure you’re doing the things to make it happen. Whereas if it's a high risk and a negative situation, you want to do the things to make sure it doesn't happen.”

There are two ways to measure impact: qualitative and quantitative. “Are we going to do just a qualitative risk assessment, where we're talking about the likelihood and the probability or the urgency of that risk?” asks Zucker. “Or are we going to do a quantitative risk assessment, where we're putting a dollar figure or a time figure to those risks?”

Most often, a team will analyze and measure risk based on qualitative impact. The team will analyze risk based on a qualitative description of what could happen, such as a project being delayed or failing. The team may judge that impact as significant but won’t put a dollar figure on it.

A quantitative risk assessment, on the other hand, estimates the impact in numbers, often measured in dollars or profits lost, should a risk happen. “Typically, for most projects, we don’t do a quantitative risk assessment,” Zucker says. “It’s usually when we’re doing engineering projects  or big, federal projects. That’s where we're doing the quantitative.”

Step 4: Determine the Risk Score of Each Event

Once your team assesses possible risks, along with the risk probability and impact, it’s time to determine a risk score for each potential event. This score allows your organization to understand the risks that need the most attention.

Often, teams will use a simple risk matrix to determine that risk score. Your team will assign a score based on the probability of each risk event. It will then assign a second score based on the impact that event would have on the organization. Those two figures multiplied will give you each event or risk a risk score.

Zucker says he prefers to assign the numbers 1, 5, and 10 — for low, medium, and high — to both the likelihood of an event happening and its impact. In that scenario, an event with a low likelihood of happening (level of 1) and low impact (level of 1) would have a total risk score of 1 (1 multiplied by 1). An event with a high likelihood of happening (level of 10) and a large impact (level of 10) would have a total risk score of 100.

Zucker says he prefers using those numbers because a scale as small as one to three doesn't convey the importance of high-probability and high-impact risks. “A nine doesn't feel that bad,” he says. “But if it's 100, it's like, ‘Whoa, I really need to worry about that thing.’”

While these risk matrices use numbers, they are not really quantitative. Your teams are making qualitative judgments on events and assigning a rough score. In some cases, however, teams can determine a quantitative risk score.

Your team might determine, based on past projects or other information, that an event has a 10 percent chance of happening. For example, if that event will diminish your manufacturing plant’s production capacity by 50 percent for one month, your team might determine that it will cost your company $400,000. In that case, the risk would have a risk score of $40,000.

At the same time, another event might have a 40 percent chance of happening. Your team might determine the cost to the business would be $10,000. In that case, the risk score is $4,000.

“Just simple counts start to give you a quantifiable way of looking at risk,” says Wills. “A risk that is going to delay 10 percent of your production capacity is a different kind of risk than one that will delay 50 percent of it. Because you have a number, you can gather real operational data for a week or two and see how things support the argument. You can start to compare apples to apples, not apples to fish.”

Wills adds, “Humans, being very optimistic and terrible at predicting the future, will say, ‘Oh, I don't think it'll happen very often.’ Quantitative techniques help to get you away from this gambler fallacy kind of approach. They can make or break your argument to a stakeholder that says, ‘I've looked at this, and I can explain mechanically, count by the numbers like an accountant, what's going on and what might go wrong.’”

Step 5: Understand Your Risk Tolerance

As your team considers risks, it must understand the organization’s risk tolerance. Your team should know what kinds of risks that organizational leaders and stakeholders are willing to take to see a project through.

Understanding that tolerance will also help your team decide how and where to invest time and resources in order to prevent certain negative events.

Step 6: Decide How to Prioritize Risks

Once your team has determined the risk score for each risk, it will see which potential risks need the most attention. These are risks that are high impact and that your organization will want to work hard to prevent.

“You want to attack the ones that are high impact and high likelihood first,” says Romeu. 

“Some projects are just so vital to what you do and how you do it that you cannot tolerate the risk of derailment or major failure,” says Wills. “So you're willing to spend money, time, and effort to contain that risk. On other projects, you're taking a flier. You're willing to lose a little money, lose a little effort.”

“You have to decide, based on your project, based on your organization, the markets you're in, is that an ‘oh my gosh, it's gonna keep me up every night’ kind of strategic risk? Or is it one you can deal with?” he says.

Step 7: Develop Risk Response Strategies

Once your team has assessed all possible risks and ranked them by importance, you will want to dive deeper into risk response strategies. That plan should include ways to respond to both positive and negative risks.

These are the main strategies for responding to threats or negative risks:

• Mitigate: These are actions you will take to reduce the likelihood of a risk event happening or that will reduce the impact if it does happen. “For example, if you’re building a datacenter, we might have backup power generators to mitigate the likelihood or the impact of a power loss,” says Zucker. You can learn more, including more tips from experts, about project risk mitigation .
• Avoid: If a certain action, new product, or new service carries an unacceptably high risk, you might want to avoid it entirely. 
• Transfer: The most common way that organizations transfer risk is by buying insurance. A common example is fire insurance for a building. Another is cybersecurity insurance that would cover your company in the event of a data breach. An additional option is to transfer certain risks to other companies that can do the work and assume its risks for your company. “It could be if you didn't want to have the risk of running a datacenter anymore, you transfer that risk to Jeff Bezos (Amazon Web Services) or to Google or whoever,” Zucker says.

These are the main strategies for responding to opportunities or positive risks:

• Share: Your company might partner with another company to work together on achieving an opportunity, and then share in the benefits.
• Exploit: Your company and team work hard to make sure an event happens because it will benefit your company.
• Enhance: Your company works to improve the likelihood of something happening, with the understanding that it might not happen.

These are the main strategies for responding to both threats and opportunities, or negative and positive risks:

• Accept: Your company simply accepts that a risk might happen but continues on because the benefits of the action are significant. “You're not ignoring the risks, but you're saying, ‘I can't do anything practical about them,’” says Wills. “So they're there. But I'm not going to spend gray matter driving myself crazy thinking about them.”
• Escalate: This is when a project manager sees a risk as exceptionally high, impactful, and beyond their purview. The project manager should then escalate information about the risk to company leaders. They can then help decide what needs to happen. “Some project managers seem almost fearful about communicating risks to organization leaders,” Romeu says. “It drives me nuts. It's about communicating at the right level to the right people. At the executive level, it’s about communicating what risks are happening and what the impact of those risks are. If they happen, everybody knows what the plan is. And people aren't taken by surprise.”

Step 8: Monitor Your Risk Plans

Your team will want to understand how viable your organization’s risk plans are. That means you might want to monitor how they might work or how to test them.

A common example might be all-hands desktop exercises on a disaster plan. For example, how will a hospital respond to a power failure or earthquake? It’s like a fire drill, Zucker says. “Did we have a plan? Do people know what to do when the risk event occurs?”

Step 9: Perform Risk Assessments Continually

Your team will want to continually assess risks to the project. This step should happen throughout your project, from project planning to execution to closeout. 

Zucker explains that the biggest mistake teams tend to make with project risk assessment: “People think it's a one-and-done event. They say, ‘I’ve put together my risk register, we’ve filed it into the documents that we needed to file, and I'm not worrying about it.’ I think that is probably the most common issue: that people don't keep it up. They don't think about it.”

Not thinking about how risks change and evolve throughout a project means project leaders won’t be ready for something when it happens. That’s why doing continual risk assessment as a primary part of risk management is vital, says Wills.

“Risk management is a process that should start before you start doing that activity. As you have that second dream about doing that project, start thinking about risk management,” he says. “And when you have completely retired that thing — you've shut down the business, you've pensioned everybody off, you’re clipping your coupons and working on your backstroke — that's when you're done with risk management. It's just a living, breathing, ongoing thing.”

Experts say project managers must learn to develop a sense for always assessing and monitoring risk. “As a PM, you should, in every single meeting you have, listen for risks,” Romeu says. “A technical person might say, ‘Well, this is going to be difficult because of X or Y or Z.’ That's a risk. They don't understand that's a risk, but as a PM, you should be aware of that.”

Step 10: Identify Lessons Learned

After your project is finished, your team should come together to identify the lessons learned during the project. Create a lessons learned document for future use. Include information about project risks in the discussion and the final document.

By keeping track of risks in a lessons learned document, you allow future leaders of similar projects to learn from your successes and failures. As a result, they can better understand the risks that could affect their project.

“Those lessons learned should feed back into the system — back into that original risk checklist,” Romeu says. “So the next software development project knows to look at these risks that you found.”

How to Write a Project Risk Assessment Report

Teams will often track risks in an online document that is accessible to all team members and organization leaders. Sometimes, a project manager will also create a separate project risk assessment report for top leaders or stakeholders.

Here are some tips for creating that report:

• Find an Appropriate Template for Your Organization, Industry, and Project: You can find a number of templates that will help guide you in creating a risk assessment report. Find a project risk assessment report template in our project risk assessment starter kit.
• Consider Your Audience: As you create the report, remember your audience. For example, a report for a technical team will be more detailed than a report for the CEO of your company. Some more detailed reports for project team members might include a full list of risks, which would be 100 or more. “But don't show executives that list; they will lose their mind,” says Romeu.

Project Risk Assessment Starter Kit

Download Project Risk Assessment Starter Kit

This starter kit includes a checklist on assessing possible project risks, a risk register template, a template for a risk impact matrix, a quantitative risk impact matrix, a project risk assessment report template, and a project risk response table. The kit will help your team better understand how to assess and continually monitor risks to a project.

In this kit, you’ll find: 

• A risk assessment checklist PDF document and Microsoft Word to help you identify potential risks for your project. The checklist included in the starter kit is based on a document from Alluvionic Project Management Services.
• A project risk register template for Microsoft Excel to help you identify, analyze, and track project risks.
• A project risk impact assessment matrix for Microsoft Excel to assess the probability and impact of various risks.
• A quantitative project risk impact matrix for Microsoft Excel to quantify the probability and impact of various risks. 
• A project risk assessment report template for Microsoft Excel to help you communicate your risk assessment findings and risk mitigation plans to company leadership.
• A project risk response diagram PDF document and Microsoft Word to better understand how to respond to various positive and negative risks.

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The Smartsheet platform makes it easy to plan, capture, manage, and report on work from anywhere, helping your team be more effective and get more done. Report on key metrics and get real-time visibility into work as it happens with roll-up reports, dashboards, and automated workflows built to keep your team connected and informed. 

When teams have clarity into the work getting done, there’s no telling how much more they can accomplish in the same amount of time.  Try Smartsheet for free, today.

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• v.16(2); May-Aug 2012

Risk assessment: A neglected tool for health, safety, and environment management

Damodar vishnu lele.

Retired Occupational Health Physician, HUL, A-6, Bhagirath Society, Plot no 8, Jayaprakash Nagar, Goregaon (E), Mumbai, India

Risk assessment has become a standard phrase in health, safety, and environment (HSE) management over the last couple of decades. Although many people have heard of it, not so many know what it really means.

Risk assessment is nothing more than a careful examination of what, in our work, could cause harm to people, so that we can weigh up whether we have taken enough precautions or should do more to prevent harm. The aim is to make sure that no one gets hurt or becomes ill. It involves identifying the hazards present in any undertaking (whether arising from work activities or from other factors, e.g. the layout of the premises) and then evaluating the extent of the risks involved, taking into account existing precautions.

Unknown, hidden, undetected or unrelated risks cause more uneasiness. Moreover, employees use their own procedures when not being directed or when not being supervised. We look for unsafe conditions but not for unsafe acts, may be because of ignorance, arrogance, apathy or complacency. We need to uncover unsafe practices during our rounds to understand the reasons for such practices. What we find depends upon what we look for.

The results of a suitable and sufficient risk assessment would help users to choose which good preventive / corrective practice measures are most appropriate.

The main use of quantitative analysis is to understand risk and how best to reduce it and not to prove that something is safe.

Our ability to eliminate or control risks depends entirely on our ability to identify/anticipate them. Risk cannot be managed or addressed unless it is first identified. Risk assessment is a proactive process, not a reactive one—prepare for risks before they happen. Identify risks and develop appropriate risk mitigating strategies before things go wrong.

WE CAN CHANGE THE CONDITIONS UNDER WHICH PEOPLE WORK

It is important for all of us to be aware of the intentions behind risk assessment. Many employers view risk assessment as mere legal/statutory requirement or as a certification requirement and are contented to have few pieces of paper with a few notes on it. This is not sufficient.

It should also be understood that severity of a risk cannot be reduced. We can only bring down the probability or likelihood down to an acceptable level.

WHY IS RISK ASSESSMENT IMPORTANT?

It is a first step towards systematic, successful occupational HSE management. We start of by getting basics right.

The only alternative to risk management is crisis management and crisis management is more expensive, time consuming, and embarrassing. A risk is something that can be a problem in the future. Risks may turn into problems. We can reduce or avoid future problems by reducing their probabilities or consequences.

It is important to know the risks and to ensure that there is a real reduction in the exposure of workers and we are just not replacing one risk with another.

There is a risk in everything we do. As individuals we carry out risk assessments subconsciously all the time, for example, where, how, and when to cross the road. We do these assessments quickly, and we base them on experience, the available information, common sense, and our own judgment.

Risk assessment is a continuous process!

IT IS NOT ABOUT: Stopping people from doing things, Creating long, complex, and bureaucratic arrangements.

IT IS ABOUT: Identifying ways of enabling people to do things in a safe way, Identifying practical steps to protect people from the risks that cause real harm and suffering.

Quality of risk assessment will depend upon resources availability, information, training, experience, support, time devoted, involvement, motivation and interest of the team, and its composition.

Employees, at times, out of helplessness, voluntarily or habitually accept risks and suffer unnecessarily. Risks also creep in when they are accepted due to familiarity or saturation.

Ignorance and indifference are the worst enemies which can be corrected only by raising awareness and by continuous training. Ignorance, apathy, “Chalata hai” attitude,” not my job” philosophy, and poor motivation create problems during effective management of HSE.

“In most disasters there was obvious prior warning of what could occur but management failed to act. Most root causes are associated with weaknesses, defects, or breakdowns in Management Systems. “Accidents are not due to lack of knowledge, but failure to use the knowledge we have.”

Many businesses think that undertaking risk assessment is a difficult and complicated process, and as a result, it is often misunderstood. For this reason many companies employ third party consultants to complete a series of assessments and prepare the required documentation, which is neither understood nor read by anybody in the company and is finally deposited in a remote cupboard/bookshelf never to be opened/read till next audit.

Hazard identification and risk assessment methodologies vary greatly across industries, ranging from simple assessment to complex quantitative analyses with extensive documentation. Individual hazards may require that different methods be used, e.g. an assessment of long term exposure to chemicals may need a different method than that taken for equipment safety or for assessing an office workstation. Each organization should choose approaches that are appropriate to its scope, nature, and size, and which meet its needs in terms of detail, complexity, time, cost, and availability of reliable data. Taken together, the chosen approaches should result in a comprehensive methodology for the ongoing evaluation of the organization's risk.

BUT WHAT IF THE ASSESSMENT IS FLAWED? WHERE DO WE FAIL?

What should we do after we have carried out a risk assessment.

Take Action!

A risk (high, medium or low) is the chance that somebody will be harmed by the hazard (e.g. the likelihood of somebody falling off a ladder or suffering an electric shock).

Interventions should be agreed with the workforce (either directly or through worker safety representatives). The agreed solutions should be carefully implemented, monitored, and evaluated. The information arising from the risk assessment must be shared with the appropriate persons.

MONITOR AND REVIEW THE FINDINGS

It is important to perform and use evaluation as a way to assess which aspects of the interventions were successful and which were not, and to see what works best for the specific establishment.

Assess the effectiveness of the control measures ensure that the risks have been appropriately reduced and that other hazards have not been created. Ways of working change, and so do hazards and risks. When a significant change takes place, check to make sure that there are no new hazards that need addressing. Repeat the risk assessment when necessary.

COMMUNICATE

The biggest problem with communication is the illusion that it has been accomplished. Tell people what you are doing. Talk to the worker representatives. Involve them in the risk assessment process and tell them what you are doing to reduce risk. Participation makes them accountable as well.

THE NEED FOR REGULAR MANAGEMENT REVIEWS AND LOOK FOR CHANGING RISKS

The tone from the top is important with appropriate decisions based on regular review. Risk assessment is not a one-off event. It is (or should be) a continuous event that reacts to change.

CONDUCT REVIEW IF: There is a reason to believe that it is no longer valid, There has been a significant change in the matters to which it relates.

It is good practice for assessments to be reviewed at regular intervals as well to ensure that changes have not slipped through.

Most systems fail not because of inherent flaws but because nobody is making sure they are maintained and linked to all other programs and systems.

Consequences of failure are becoming less and less permissible due to enormous repercussions.

We are creatures of habit; find a way to sustain the focus and it will become second nature.

It is a nonstop race where newer and newer hazards are introduced every day with changes in technology and with newer inventions. We may have to look at newer developments such as nanotechnology, biotechnology, communications technology, etc. carefully and understand them better to proactively work for eliminating/reducing their risks.

The causes of tomorrow's events exist today!

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Research risk assessment

It's the responsibility of the principal investigators (PI) and researchers to identify reasonably foreseeable risks associated with their research and control the risks so far as is reasonably practicable.

All participants and research assistants have the right to expect protection from physical, psychological, social, legal and economic harm at all times during an investigation. Certain research may also present reputational, legal and / or economic risks to the University.

As part of the ethical approval process for research involving human participants you are required to identify potential risks associated with your research and the action you will take to mitigate risk. You may be asked to submit your risk assessment.

The risk assessment process is a careful examination of what could cause harm, who/what could be harmed and how. It will help you to determine what risk control measures are needed and whether you are doing enough. 

Risk assessment responsibility

The PI and researchers need to take responsibility for all assessments associated with their projects. Occasionally you may need research workers or students to risk assess an aspect of the work and you will need to check the assessments are adequate and sign them off.

Risk assessors need to be competent and you’ll need to ensure they have adequate training and resource to do the assessments. There is risk assessment training available and help and advice help and advice help and advice from your Health and Safety Advisory Service link advisor and safety specialists (for health and safety risks), or the REO Research Governance team for other risks. In some cases, the hazards are so unique to the research that the PI and their team might be the only people who know the work well enough to make valid judgements about the risk and justify their conclusions.

Risk assessment process

The risk assessment process is a careful examination of what could cause harm, who/what could be harmed and how. It will help you to determine what risk control measures are needed and whether you are doing enough.

To simplify the process you can use the health and safety risk assessment templates, risk estimation tool and guidance for all risks associated with your research project. Please refer to the research risk estimation guidance under how to carry out a risk assessment below to assist you. 

Research risks

Typical risks that need to be considered as part of research ethics are:

• Social risks: disclosures that could affect participants standing in the community, in their family, and their job.
• Legal risks: activities that could result in the participant, researchers and / or University committing an offence; activities that might lead to a participant disclosing criminal activity to a researcher which would necessitate reporting to enforcement authorities; activities that could result in a civil claim for compensation.
• Economic harm: financial harm to participant, researcher and / or University through disclosure or other event.
• Reputational risk: damage to public perception of University or the University/researchers’ reputation in the eyes of funders, the research community and / or the general public. 
• Safeguarding risks:   Risk to young people, vulnerable adults and / or researcher from improper behaviour, abuse or exploitation. Risk to researcher of being in a comprising situation, in which there might be accusations of improper behaviour.
• Health and safety risks: risks of harm to health, physical injury or psychological harm to participants or the researcher. Further information on health and safety risks is given below.

Health and safety risks

The potential hazards and risks in research can be many and varied. You will need to be competent and familiar with the work or know where to obtain expert advice to ensure you have identified reasonably foreseeable risks. Here are some common research hazards and risks:

• Location hazards Location hazards Location hazards and risks are associated with where the research is carried out. For example: fire; visiting or working in participant’s homes; working in remote locations and in high crime areas; overseas travel; hot, cold or extreme weather conditions; working on or by water. Also hazardous work locations, such as construction sites, confined spaces, roofs or laboratories. For overseas travel, you will need to check country / city specific information, travel health requirements and consider emergency arrangements as part of your research planning, by following the University’s overseas travel  health and safety standard .  
• Activity hazards Activity hazards Activity hazards and risks associated with the tasks carried out. For example: potentially mentally harmful activities; distressing and stressful work and content; driving; tripping, or slipping; falling from height; physically demanding work; lifting, carrying, pushing and pulling loads; night time and weekend working.
• Machinery and equipment Machinery and equipment Machinery and equipment . For example: ergonomic hazards, including computer workstations and equipment; contact with electricity; contact with moving, rotating, ejecting or cutting parts in machinery and instruments; accidental release of energy from machines and instruments.
• Chemicals and other hazardous substances . The use, production, storage, waste, transportation and accidental release of chemicals and hazardous substances; flammable, dangerous and explosive substances; asphyxiating gases; allergens; biological agents, blood and blood products. You’ll need to gather information about the amount, frequency and duration of exposure and carry out a COSHH or DSEAR assessment which will inform whether you may need health surveillance for yourself and / or your research participants.
• Physical agents Physical agents Physical agents . For example: excessive noise exposure, hand-arm vibration and whole body vibration; ionising radiation; lasers; artificial optical radiation and electromagnetic fields. You’ll need to gather information about the amount, frequency and duration of exposure inform whether you may need health surveillance for yourself and / or your research participants.

When to carry out a risk assessment

Carrying out initial risk assessments as part of the planning process will help you identify whether existing resources and facilities are adequate to ensure risk control, or if the project needs to be altered accordingly. It will also help you to identify potential costs that need to be considered as part of the funding bid.

Once the project is approved, research specific risk assessments need to be carried out before work starts.

The research may need ethical approval if there is significant risk to participants, researchers or the University.

How to carry out a risk assessment

The University standard on risk assessments provides guidance, tips on getting it right, as well as resources and the forms to help you produce suitable and sufficient risk assessments and must be used.

• Risk assessment template (.dotx)
• Flow chart to research risk assessment (.pdf)
• Research risk assessment: Risk estimation tool (.pdf)
• Example of a Social Science research risk assessment (.pdf)

Refer to carrying out a risk assessment carrying out a risk assessment carrying out a risk assessment for step by step guidance.

Risk assessments must relate to the actual work and must be monitored by the PI. If there are significant changes to the activities, locations, equipment or substances used, the risk assessment will need to reviewed, updated and the old version archived. Risk assessments should also consider the end of projects, arrangements for waste disposal, equipment, controlled area decommission and emergencies. 

Things to consider:

• The risks may be specialist in nature or general. Information can found from legislation, sector guidance, safety data sheets, manufacturers equipment information, research documents, forums and health and safety professionals.
• Practical research might involve less well-known hazards. Do you or your team have the expertise to assess the risk adequately? Do you know who to go to for expert advice?
• The capabilities, training, knowledge, skills and experience of the project team members. Are they competent or are there gaps?
• In fast changing research environments, is there a need to carry out dynamic risk assessments? Are they understood and recorded?
• The right personal protective equipment for the hazards identified and training in how to use it.
• Specific Occupational Health vaccinations, health surveillance and screening requirements identified and undertaken. With physical agents and substances you’ll need to make an informed decision about the amount, frequency and duration of exposure. If you need help with this contact HSAS.
• Associated activities: storage, transport/travel, cleaning, maintenance, foreseeable emergencies (eg spillages), decommissioning and disposal.
• The safe design, testing and maintenance of the facilities and equipment.
• Planned and preventative maintenance of general plant and specialist equipment.

These risk assessments relate to the actual work and must be monitored by the PI. If there are significant changes to the activities, locations, equipment or substances used, the risk assessment will need to reviewed, updated and the old version archived. Risk assessments should also consider the end of projects, arrangements for waste disposal, equipment and controlled area decommission and emergencies.

Training 

If you would like training on risk assessment, please book onto one of our courses:

• Research Risk Assessment (for research staff and students in Humanities and Social Sciences)
• Research Risk Assessment (for research staff and students in Faculty of Science of Health only)
• Carrying out a risk assessment Carrying out a risk assessment Carrying out a risk assessment
• People especially at risk People especially at risk People especially at risk
• IOSH/USHA/UCEA guidance on managing health and safety in research (.pdf) 
• Research governance: Ethical approval

• For enquiries contact your Student Services Hub
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Risk assessment keeps everyone safe

By David Paterson 2023-02-01T07:45:00+00:00

• No comments

Teach your students to recognise the dangers that can exist in the laboratory and how to combat them

Risk assessment is a process we all do in our everyday lives, often without realising.

When we cross a road, we make a risk assessment – identifying the hazard of crossing in traffic, the harm of being hit by a vehicle, the severity of that harm. We identify control measures of looking for traffic, selecting safer places to cross, moving across the road quickly.

All this might happen very quickly in our minds, so we don’t see it as a process. This comes from having internalised our training when we were younger, and applying the control measures frequently.

Students need to develop knowledge and skills in risk assessment

When we carry out practical work, we are risk assessing both in the situation and, more deliberately and formally, in our planning . As part of their scientific education, students need to develop knowledge and skills in risk assessment. This starts from their first day in the laboratory, right up to self-directed extended investigation. Knowing about hazards, risks and control measures is key to keeping themselves and others safe.

Exam specifications require students to be competent and safe at handling hazardous substances and apparatus, and to carry out experimental procedures with minimised risk. In their future study and careers, they will be in a world where health and safety procedures are a prominent part of their day-to-day lives.

Download this

Student risk assessment worksheets, for age range 14–16

Guide learners to recognise hazards, evaluate risks and identify control measures in a common core practical.

Download the student worksheets as MS Word or pdf and the teacher notes as MS Word or pdf .

Download the resources from the Education in Chemistry website: rsc.li/3Y9tlcN

Source: © Tobatron

Start simply

Start your students’ education with a fundamental piece of kit – the Bunsen burner. Discuss the safety features. Train students in setting up, using and clearing away the equipment. Guide them in identifying the hazards involved, and the control measures that we put in place to reduce the risks, and keep them and others safe. Provide students with a copy of Student safety sheet SSS092 , one of a range of information sheets from CLEAPSS written specifically for students. Teachers in Scotland can also access resources from SSERC ; their website has a number of activity sheets with risk assessments.  

As students develop their competencies in the laboratory, you use further SSSs to provide additional support and reference. Information on heating non-flammable and flammable substances, transferring solids and liquids, and handling hot liquids in beakers is available. Glossaries, waste disposal information and details of CLP (control, labelling and packaging) and other safety pictograms are included and can be used as ready reference material in the classroom.

Build knowledge and experience

As they progress through their education, give students the opportunity to assess risk more formally. Start with pre-practical activities of looking up the hazard information of substances that will be used in the upcoming practical. For example, SSS020 will quickly show students that hydrochloric acid is available at a range of concentrations, with hazards running from ‘DANGER: Corrosive’ to ‘Currently not classified as hazardous’. Discuss with your students the importance of assessing the risk based on what they will actually be using, rather than just imposing the strictest set of control measures possible.

When students start carrying out more detailed investigative work, use a risk assessment pro forma to help guide their thinking and decisions. Three different formats are available in the SSS pack, as well as an exemplar based on the common practical making copper sulfate crystals.

Recommended reading and resources

• Stay on top of your own risk assessments by  risk assessing your practicals . 
• Emphasise risk and working safely to your 14–16 students with this practical video on preparing a soluble salt .
• Show students how important understanding and mitigating risk is in the real world by sharing job profiles from  Nicholas, a toxicologist and Tim, a computational toxicologist .
• Stay on top of your own risk assessments by risk assessing your practicals: rsc.li/3w9G0AD
• Emphasise risk and working safely to your 14–16 students with a video on preparing a soluble salt practical: rsc.li/3WoCP2u
• Show students how important understanding and mitigating risk is in the real world by sharing job profiels from a toxicologist and a computational toxicologist: rsc.li/3ZJ6PZW; rsc.li/3WleRW1

Teachers remain responsible for the final risk assessment in our labs. However, involving students in the processes will make them think more carefully about what they are doing. Their learning in science lessons can also feed into other areas of study.

One final aspect of good risk assessment is to consider what happens in an emergency. As adults, we tend to respond better to emergencies, due to our training and experience. Help train your students by discussing situations that can occur, and how best to respond. The emergency actions document (SSS096b) provides a useful summary.

Risk assessment is a critical part of carrying out practical work in the chemistry classroom. By involving students in the process, by developing their knowledge and skills of hazards and risks, we prepare them better for activities both in and out of the science lab. Risk assessment helps our students to stay safe.

This article is part of our Teaching science skills series, bringing together strategies and classroom activities to help your learners develop essential scientific skills, from literacy to risk assessment and more.

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Risk assessment process and key points to risk identification in virtual interactions

Published: March 2023

Virtual interactions with people that access care and support are here to stay, in one form or another. Where it is appropriate and proportionate to interact with an individual in a way other than face to face, it is necessary to be confident and competent to practice in a way that recognises and works effectively with risk.

This guide will help social care practitioners to understand:

• The key principles of how to gather evidence and information, so they are able to identify and assess risks virtually when it is not necessary or appropriate to do so through face-to-face contact.
• The importance of being aware that our professional decisions may become more reliant on assumptions or information provided by others, as we may have less ability to observe and draw conclusions from direct observation. However, as with any social care practice, it is essential that we are able to defend any decision made with the evidence that underpins it.
• That regardless of the method of interaction we should always be mindful of situations that present risk and should try to gather as much information as possible about the individuals’ circumstances to ensure any risks are identified and looked at properly.
• The importance of clearly documenting the entirety of the risk assessment process and particularly evidence associated with risk.
• “Critical, reflexive and careful judgement … with the fully considered evidence of incomplete knowledge so that you can defend and justify your assessments, plans and interventions” (Cooper, 2011).

If the adult lacks capacity, some of the statements below will not apply, and decisions and agreements will be made with as much involvement as possible from the adult but not solely with them.

Risk assessment as a process

Risk assessment is an important process in adult social care as we work with individuals to enable them to achieve the outcomes that matter to them and promote their individual wellbeing.

The risk assessment process has four distinctive and  sequential  stages, and social care practitioners should go through each of them with the individual.

• Understanding the person’s circumstances
• Identifying risks
• Assessing impact and likelihood of risks
• Managing risks – risk enablement and planning

This framework is evident in a study undertaken by Clarke et al. (2011) which outlined a four-stage process for exploring risk with individuals and families living with dementia. However, this further guidance is equally as applicable for working with all individuals:

• Identify risks in the life-context of the individual and their circumstances (and therefore impact on quality of life and individual wellbeing).
• Identify risk perspectives from all the people involved.
• Identify weighting of risks (to establish high and low risk concerns, impact on emotional, social and psychological wellbeing).
• Identify current and past strategies for managing risks.

When we work with individuals during the risk assessment process it is important to remember that a person’s ability to engage can fluctuate either as a result of a cognitive impairment of the mind or brain or due to physical or emotional difficulties. In such circumstances it will be necessary to arrange conversations at times that are appropriate for them and/or provide additional support if required such as:

• Appropriate Person
• Independent Advocate, or
• Independent Mental Capacity Act Advocate.

What is risk?

Simply put, risk is:

• The probability that an event will occur with beneficial or harmful outcomes for a particular person or others with whom they come into contact.
• A product of the likelihood that an event will occur and the impact that it will have if it does occur.

The four stages of risk assessment as a process

Understanding the person’s circumstances (stage 1).

Risk is part of everyday life and “people with disabilities, both mental and physical, have the same human rights as the rest of the human race. It may be that those rights have sometimes to be limited or restricted because of their disabilities, but the starting point should be the same as that for everyone else” (Lady Hale, 2014).

When we work with individuals requiring support from Adult Social Care, we do so to promote choice and control for which there are likely to be elements of risk present. However, our practice is underpinned by strengths-based principles which recognises strengths, capabilities and potentials for self-directed support towards goals and outcomes that matters to the individual.

It may therefore be necessary and/or beneficial for some risk to be present but in such circumstances the decision should be made through,

Weighing up the potential benefits and harms of exercising one choice of action over another. This means identifying the potential risks involved, and developing plans and actions that reflect the positive potentials and stated priorities of the service user. It involves using available resources and support to achieve desired outcomes, and to minimise potential harmful outcomes.

Read  “principles of practice”  for some further guidance to help you understand the person’s circumstances.

Identifying risks and protective factors (Stage 2)

A social care practitioner’s role is to support an individual to identify, define and explore the beneficial or harmful outcomes of the identified activity/decision with the individual. This is to enable a thorough exploration which will allow consideration of the likelihood and impact and promote their ability to live the life they want and do the things that are important to them as independently as possible. Our role is not to stop people doing things but to trust people to make decisions and direct their own support, with help where they need and want it.

The first step of the risk assessment process is to jointly work with the individual, with or without the support of another person (for example an appropriate individual or independent advocate), to enable us to understand:

• what the activity means to them
• why is it important to them and for them
• what impact being able/unable to undertake the activity will have on their individual wellbeing.

It is important that when we engage in conversations, we begin from a position of strength, focusing on what is strong for the individual and not on what is wrong with the decisions they are wanting to make. We can learn from the principles of  appreciative inquiry  and rather than seeing the situation as a problem to be solved, consider it as a mystery to be embraced, utilising strengths, rather than seeking to overcome or minimise the weaknesses. We can, with an open mind, seek to explore and discover moments of strengths in the individual’s life, personal qualities and the networks around them. We can be open to seeing new potential and possibilities using the collective knowledge of the social care practitioner and the individual to whom the assessment belongs.

Once you have established a baseline understanding of the persons circumstances from their perspective, it is important to work with them to identify both the potential benefits and the potential harms of a given action, decision, behaviour, etc.

This enables us to support the individual to explore the risks that they are facing, or are likely to face, and the impact of the activity on them or others, now or in the future.

Working virtually with an individual will place a greater reliance upon the questions we ask in order to establish a baseline understanding of the person and find the answers to potential benefits or harms as we cannot use our other senses such as seeing for ourselves.

From the available information and initial contact with the individual, it should be possible to gauge a level of insight as to the potential harmful outcomes, likelihood of occurrence and potential impact. We should use this to determine which  method of interaction  is required, for example it is necessary to visit the individual in person or it is appropriate to, at least, start the risk assessment process virtually. It is important that we record our rationale for the chosen method(s) of interaction.

Pause for thought: Case study – about Amitesh

Amitesh is a 28-year-old male who lives with an acquired brain injury and limited use of his right side. He moved from residential care to supported living one year ago. He is unable to access the community without support which is authorised by a community Deprivation of Liberty Safeguard. (DOLiC)

You have arranged to review Amitesh’s care and support plan with his support worker and Mum, who is acting as his Appropriate Person. The appointment will be via video call. He has explained that he wants to discuss how he will be able go to the local supermarket without support.

Thinking about the first two steps of the risk process, what questions do you think you need to ask? SCIE will share its thoughts below to offer further guidance to shape your question creation.

SCIE’s thoughts

It is important that the conversations that we have enable us to evidence some key points, such as:

• What is it that is trying to be achieved and why?
• How will it be achieved and why will it be done this way?
• What are the potential benefits of the action being considered? To self, to others, from others, etc.
• What could go wrong? – what are the risks to self, to others, from others etc.

The answer to these questions:

• Must  be seen from the individual’s point of view, though we will support the individual in exploring and understanding all the potential benefits and harms.
• Should  include the individual wishes and aspirations.
• May  include potential benefits for others but  must  include any potential harm to others.

Potential prompts to go through with the individual are:

• What is the good thing about doing this?
• What will I get out of it?
• What could go wrong if I don’t do it?
• What could go wrong if I do it?

With support, Amitesh was able to identify that it was important for him to go to the shops by himself to buy chocolate. He wants to do this as his friends who lived around him did so and not being able to do it made him feel sad and frustrated and it made him feel like a child.

Being able to go to the shop when he wanted and by himself would help him feel independent and he could use the communal mobility scooter to help him get there because he cannot walk very far.

Amitesh identified that it had been over 10 years since he had been out in the community without support, that he might get lost on the way to the shop and/or forget what he had gone to the shop for or not know if he has been given the right change.

To explore further the concern around not getting the right change and to ascertain if it is a risk, Amitesh was asked if he has any money close by and if he knows the value of the notes and coins that he had; simple questions were asked such as if he paid with a £5 note would he expect any change if the item cost 50 pence?

A balance sheet for supporting exploration of risk, protective factors and options

During the conversation we need to be able explore ways in which Amitesh could achieve the outcome he wishes to achieve, and a balance sheet tool may be a useful way of doing this.

The format of such a tool is not important but the detail which we add to it is key. A balance sheet:

• Provides an opportunity to work through and identify possible options for the person to achieve their desired outcome while minimising risk, where possible.
• Enables recording of the evidence gathered to demonstrate the advantages and disadvantages of the considered option which will be used to make decisions.
• Supports the analysis as to why it is or is not a realistic option, with reference to the facts that resulted in the decisions made.
• Enables the process to be open and transparent with the people we work with.

Activity: Getting to the shop

It may be necessary to have more than one interaction with Amitesh, to ascertain all the risks involved in relation to the decision to be made. These interactions can be using one or different methods.

The important thing is that we can evidence and define with clarity what the risks are from the perspective of the individual, the social care practitioner and any others as this will support the next stages or be affected by the decision. It is not possible to consider the impact and likelihood of a situation or take steps to manage it if we cannot define what the risk is first.

Assessing risks: impact and likelihood (stage 3)

Once the risk has been clearly defined and the potential beneficial and harmful effects identified, we will explore with the individual the impact and likelihood of each of the potential benefits and harms identified to assess the risk.

This stage is not:

• a method to prevent a person to achieve the outcomes that they would choose
• an opportunity to focus on the problem/s and things that are perceived to be a risk.

As a social care practitioner is not our responsibility to take the risk away. At this stage we should:

• Support the individual with their unique strengths, abilities and aspirations to make decisions that matter to them.
• Support the individual in understanding the likelihood and impact of all the identified potential benefits and harms, what is important for them alongside what is important to them and why.

It is essential that there is an evidenced based analysis of the severity and likelihood of harm which could arise.

When we assess risk, it is necessary to explore:

• How likely is this to occur? This  should  be proportionate to the potential consequences specified, and  must  be based on good information and evidence and consider the same factors – is the information up to date? Is it relevant? Can it be evidenced? What are the protective factors which could reduce the likelihood of the occurrence? Consider the strengths of the person’s current situation, the environment and what their family/friends/other support network are or can contribute. What additional actions would promote benefit and reduce the likelihood of the occurrence, for example the use of assistive technology, interventions to improve ability of the individual, maximising existing support networks?
• If something went wrong, what would the severity of the impact be? It is important to consider both a best-case and worst-case scenario, e.g. death, serious injury, admission to hospital, loss of accommodation. If it works, what is the level of benefit of the impact? It is important to consider equally the potential negative consequences and the potential benefits What are the protective factors which could reduce the severity of the impact? What additional actions would promote the benefit and reduce the severity of the impact, for example the use of assistive technology, interventions to improve ability of the individual, maximising existing support networks.

Thinking about the impact and likelihood that of the risk process, what questions do you think you need to ask based on the information you have?

It is important to have conversations that will enable us to evidence some key points, such as:

• The likelihood of risk (degree of intent; immediacy/frequency of its occurrence or re-occurrence; timing: do different times of day or different days elevate or reduce the risk?).
• The severity of risk (i.e. the impact it could have if it occurs).
• Has something like this happened before, what are the similarities and the differences, how were they managed and to what end? Use your knowledge and experience to explore if previous solutions could help in this case.
• What’s the worst that could happen? For whom?
• What’s the best that could happen? For whom?
• What could happen if we don’t support the person to take the risk?
• Must  be seen from individual’s point of view, though we will support the individual in exploring and understanding the likelihood and severity of the decision.

An example of a risk assessment for Amitesh

Low, medium, high

Unlikely, likely, very likely

What is the decision or choice to be made?  Is it safe for Amitesh to go to the shops alone?

What are the potential  benefits?

• Amitesh can be independent in going to the shops, his confidence will grow.
• Amitesh can feel like an adult and make his own decisions about when he goes to the shop.
• Amitesh will grow as an individual.
• It is something important for Amitesh and which he aspires to achieve.
• It is very likely that these benefits could be achieved.
• Amitesh’s confidence could be increased, and he may even be able to take a next step within time.
• Staff will be available to support other residents.

What are the potential  harms?

• Amitesh could get lost. This could stress him out and/or make him vulnerable to other risks.
• Amitesh may forget what he went to the shop for and get stressed or lose his way.
• Amitesh may not get the right change and lose some money.
• It is very likely that it will go wrong as Amitesh has not been out without support for 10 years and does not have the necessary skills to be able to do so at this time.
• It is very likely that Amitesh may get lost.
• It is very likely that Amitesh may not get the right change.
• The severity could be high as Amitesh may get scared about being lost and when he is overwhelmed his ability to cope with a situation is reduced.
• Amitesh lives in a supported living complex with staff on site 24 hours.
• Amitesh has a telephone and has the phone number of the complex on speed dial which he is able to use.
• Amitesh has been using the local community, with support, and so may have recollection of important landmarks which will help him to return home.
• Supporting Amitesh to undertake a period of travel training to enable him to develop skills required to access the shop independently.
• Not taking too much money to the shop.
• Preparing a shopping list with staff in advance of going to the shop.
• Using a phone to contact staff if he gets lost.
• Using a phone to check in with staff when he has got his change.
• If staff work with Amitesh in addressing the factors that increase the risk, the risk will be properly managed.
• If staff conclude that they can’t provide Amitesh with the necessary skills and support to be able to address the factors that increase the risk, a decision should be made as to whether the remaining risk should be taken.

Stages one through three of the risk assessment process will enable the social care practitioner, regardless of method in which the intervention is undertaken, to recognise and work effectively with risk. It will enable the social care practitioner to arrive at a decision which should include the following narrative elements:

• A statement of the decision.
• The reasons for the decision.
• A description of the main alternatives.
• Reasons why the alternative may not be the best option or why the alternative may be the best option.

When we are working virtually with individuals to explore risk it is important that we are confident with the information we have been able to gather to enable us to make an informed and defendable decision:

Decisions that will withstand the harsh scrutiny of hindsight bias in the event of a risk failure … informed, balanced, proportionate and just risk decisions.

Managing risks: risk enablement and positive risk-taking (stage 4)

Risk is part of everyday life and risk management is not about trying to eliminate risk but managing risks to maximise people’s choice and control over their lives. It is about weighing up the options and utilising the available resources to achieve the desired outcome. It is “not negligent ignorance of the potential risks … it is usually a very carefully thought-out strategy for managing a specific situation or set of circumstances” (Morgan, 2004).

Not all risk can be reduced or mitigated, but all can be managed if they have been properly identified and assessed. On some occasions the management of risks entail reduction or mitigation.

Individual choice* in risk enablement: It is the adult and/or carer’s right to make choices and take risks once they understand the information available and are aware of the risks.

Risk enablement: Risk enablement involves supporting adults and/or carers to identify and assess risks and then supporting them to take the risk they choose.

* unless assessed to lack capacity.

Key aims of positive risk-taking:

Some of the key aims of positive risk-taking are:

• Empowering people
• Working in partnership with adults and/or carers
• Developing trusting working relationships
• Supporting people to access opportunities and take worthwhile chances
• Learning from experiences
• Understanding consequences of different choices/actions
• Sometimes tolerating short-term risk for long-term gain
• Making decisions based on accurate/available choices.

Once the risks have been identified and assessed, the next step is to agree with the individual how the risks are going to be managed.

The goal of risk management

The goal of the management of risk is to develop contingency actions for any predicted pitfalls, in a way which improve the quality of life of the person, to promote their independence or to stop these deteriorating if possible. Please note that this may be just to make the individual aware of the potential consequences of the risk.

To manage risk effectively, it is important to:

• Develop and implement the action plan agreed with the adult/carer.
• Have clear monitoring and reviewing systems in place if appropriate.
• Ensure accurate documentation and sharing of risk assessment/action plan with relevant partners.
• Be ready to respond to the consequences.
• Agree risks owners – who takes responsibility.

Risk action plan

A risk action plan should include:

• What actions have been agreed?
• How the actions will be carried out and their significance to success?

Who will be responsible for them?

• What is the time frame? Bear in mind that different aspects might have different time frames.

How will good communication be ensured?

• What could go wrong – and how to overcome?
• What could go well – and how to build onto it?
• Review plan and agree timescale.

Amitesh wished to be able to go to the shop without a support worker or his mum so that he could:

• be like his friends
• be more spontaneous about his day
• have his favourite chocolate bar when he wanted and not just when he had a scheduled shopping session
• have greater independence.

The assessment of risk concluded:

• There was a probability of a harmful outcome for Amitesh if he was to go to the shop alone as he could get lost, forget what he was going to the shop for and not be given the right change.
• The likelihood of the harmful outcome was high due to him having had protective oversight while accessing the community for the past 10 years.
• The impact if something goes wrong could be high as he is not able to cope with his emotions when he is feeling overwhelmed.

There are additional actions which would promote his ability to achieve his goal.

Using the information available what might the risk action plan include?

The Care Act 2014 is very clear that the starting point for care and support planning is the assumption that an individual can plan for themselves. This should be extended to the development of a risk action plan as should the notion that the plan is written in the first person to make it clear that it is the individual who owns it as it is there to support the individual to live a safer life.

Where possible, principles of co-production should be applied to support the individual to have as much control as possible over the choices that they can make.

What actions have been agreed

• I will be supported to try and learn how to get to the shop by myself.
• I will use pictures to build my shopping list so that I do not forget what I am going to the shop for.
• I will work with my support worker to learn about money and to try and understand how much money I will need for my shopping list and how much change I will get.

How the actions will be carried out and their significance to success

• I will work with my support worker for three hours each week.
• Support worker will plan the session with Amitesh.
• Support worker will notify social care practitioner of session plan and outcome.
• Support worker.
• Social care practitioner.

What is the time frame, bearing in mind that different aspects might have different time frames?

• I will work with my support worker until Christmas (three months).
• Review monthly.
• Weekly catch-up scheduled for use as required.
• My support worker will let the social care practitioner know how each session has gone.
• I can call the social care practitioner if I want to.

What could go wrong, and how to overcome it?

• The pace of activity may be overwhelming for Amitesh. Usual mood chart to be implemented before each session to enable support worker/Amitesh to gauge pitch of session and what the session will look like.
• Amitesh to be supported to use mood chart to explain feelings if it appears that he is becoming overwhelmed.
• Amitesh to be given opportunity to choose another activity to undertake if he is feeling overwhelmed.

Review plan and agree timescale

• Four-weekly.

How to work with risk virtually

During face-to-face interactions, we use our observation skills, amongst others, to understand any potential risks for the individual. Working virtually could reduce the opportunity to observe certain circumstances, behaviours, reactions, the non-verbal communication, the ability to see the unseen which could impact on evidence-based decision making.

Please note that whereas we have tried to include a wide range of risk factors there may be others not listed.

Working virtually places greater reliance on the use of effective strengths-based conversations, underpinned by open-ended questions and establishing  meaningful relationships . This will enable a two-way exploration of the presence of risk, risk identification, risk assessment, and risk management to explore how best to support the individual to achieve the outcomes that are important to them.

From the available information and initial contact with the individual, it should be possible to gauge a level of insight as to the potential risks. We should use this to determine which  method of interaction  is more suitable for example it is necessary to visit with the individual in person? Or is it appropriate to at least start the risk assessment process virtually?

Important considerations

If we are working with people virtually, we will:

• Need to use this information as a starting point to consider the conversations and the information we need to gather from the individual.
• Need to review historical/available information so that we are aware of what gaps in evidence we have.
• Consider what existing information needs to be checked out so that we do not make assumptions that the current circumstances are the same.
• Need to ensure that any sharing of data, via email for example, is done so in accordance with sharing of information and joint working protocols to prevent data breaches in line with the  Data Protection Act 2018 .
• Where possible always seek permission from the individual before requesting and sharing information but if it is necessary to facilitate the provision to the individual of health or social care services, section 2(3) of the  Health and Social Care (Safety and Quality) Act 2015  will limit repercussion.

If the adult lacks capacity, some statements will not apply, and decisions and agreements will be made with as much involvement as possible from the adult but not solely with them.

Please note that you can find information on Safeguarding risks with adults in  further reading .

What information can help social care practitioners in the identification and/or assessment of different types of risks when working virtually?

The below information is intended to support social care practitioners to ascertain which questions could be asked and/or considered to supplement the lack of opportunity to gather intelligence through observation when undertaking virtual interactions.

Please note that although we have included a wide range of risk factors, the list is not exhaustive.

The below indicators of higher risk should not be used to make assumptions, but to prompt questions and source evidence. The risks considered in this resource are those of:

• Personal/self-neglect
• Incontinence
• Environmental neglect

Carer breakdown

• Social isolation.

Examples of types of risks and factors that could increase the level of risk

Factors to increase risk of falls.

• Medical conditions
• Mobility, balance and gait
• Nutritional deficiencies
• Impaired cognition
• Visual impairments
• Foot problems
• Environmental hazards

What would be useful to know?

• Has anything changed?
• From when, why?
• Permanent or temporary?
• Previous history of falls over a 12-month period.
• What are the known side effects of medication being taken?

How might you find out if your interaction is not face-to-face?

• From the individual
• From family/friends
• From paid professionals, i.e. carers/personal assistants
• From health professionals
• From historical notes

Personal and self-neglect:

Factors to increase risk of self-neglect.

• Mental health
• Social circumstance

Signs of self-neglect

• Mouth hygiene
• Unkempt general appearance
• Visible dirt
• Sweating and body odour (especially sweat patches)
• Skin – spots
• Becoming ill often
• Not cleaning the toilet
• Not getting rid of rubbish
• Not washing clothes and bedding frequently
• Not storing food properly
• What is the person’s own perspective on their self-care?
• What are the hazards to wellbeing, mental and physical health?
• Are they able to seek help or access services to support them?
• Do they have income to resource their ability to care for themselves?

Read more:  Self-neglect at a glance .

Malnutrition:

Factors to increase risk of malnutrition.

• Mental health conditions

Signs of malnutrition

• Little or no appetite, a lack of interest in eating and drinking*
• Weight loss*
• Low energy and feeling tired
• Poor concentration
• Reduced physical ability
• Getting ill often and taking a long time to recover
• Wounds taking a long time to heal
• Feeling cold most of the time

*Can be difficult to determine if the person isn’t open and you are not seeing them face-to-face; therefore important to ask the question if other signs are flagged.

• Any known mental health conditions such as dementia, depression or eating disorders?
• Is there any social isolation?
• Is there enough income into the house, has anything recently changed?
• Are there any physical limitations, is this a recent change?
• Are there any long-term health conditions which affect appetite?
• Any issues with ability to swallow (i.e. dysphagia)?
• Any issues with ability to chew (i.e. dental issues)?

Environmental neglect and/or hoarding:

Factors to increase risk, signs of environmental neglect/hoarding.

• Unusually large number of items on furniture and/or on the floor
• Keep or collect items that may have little or no monetary value, such as junk mail and carrier bags
• Find it hard to categorise or organise items
• Have difficulties making decisions
• Struggle to manage everyday tasks, such as cooking, cleaning and paying bills
• Have poor relationships with family and/or friends
• Suspicion of other people touching items
• Obsessive thoughts and actions: fear of running out of an item or of needing it in the future; checking bins for accidentally discarded objects
• People who live alone, are unmarried
• Have had a deprived childhood (i.e. with lack of material objects)
• Has there been a change in income availability?
• Are there any long-term health conditions which is preventing them for keeping their home to their level of normal?
• Many people with hoarding disorders also experience other mental disorders, including depression, anxiety disorders, attention deficit/hyperactivity disorder or alcohol use disorder

What factors increase the risk of carer breakdown?:

Factors to increase risk of carer breakdown.

• Role confusion
• Unrealistic expectations
• Lack of control
• Unreasonable demands

Signs of carer breakdown

• Anxiety, depression, irritability
• Feeling tired and run down
• Difficulty sleeping
• Overreacting to minor nuisances
• New or worsening health problems
• Trouble concentrating and relaxing
• Feeling increasingly resentful and impatient
• Drinking, smoking, or eating more
• Neglecting own needs and responsibilities
• Cutting back on leisure activities
• Withdrawal from friends and family
• Carer’s life revolves around caregiving, but it gives them little satisfaction
• Feeling helpless and hopeless
• Is this a new behaviour?
• When did it start?
• Do they find they are irritated, angry or snappy?
• Do they feel emotional, are they anxious, worried, stressed?
• Have their food habits changed?
• Are they finding other ways to cope such as drinking or smoking more often?
• How well are they sleeping?
• How much energy do they have?
• How is their health?

Credit:  10 symptoms of carer stress – and how to beat them  (Live Better With).

What factors increase the risk of social isolation?

Factors to increase risk of social isolation.

• Living alone
• Limited finances
• Impaired mobility
• No family close by
• Sexual orientation issues
• Transportation challenges
• Divorced, separated, or widowed
• Inability to remain physically and mentally active
• Lack of access and inequality due to rural living or being part of a marginalised group
• Poor health and wellbeing including untreated hearing loss, frailty, substance abuse and poor mental health, including depression
• Societal barriers such as ageism and lack of opportunities for older adults to engage and contribute
• Unemployment
• Lack of an adequate social support network
• Bereavement
• Domestic violence
• Some mild forms of autism, such as Asperger’s Syndrome
• Dementia and Alzheimer’s

Signs of social isolation

• Deep boredom, general lack of interest and withdrawal
• Losing interest in personal hygiene
• Poor eating and nutrition
• Significant disrepair, clutter and hoarding in the house
• Strong difficulty in connecting with others in a non-superficial way
• Not having close friends, just mainly acquaintances or casual friends
• Low self-esteem and negative feelings of self-doubt
• When you try to connect or reach out, it’s not reciprocated, and you’re not seen or heard
• Leaving the house feels like stepping into the scary unknown
• Lack of motivation to arrange any calls or meetings

When exploring the suggestions, consider:

Other risks

There are other risks that social care practitioners should find out about, such as: cognitive deterioration, risk of hospital admission, risk of not taking prescribed medication, damage to equipment, lack of access to technology or the necessary skills need to use it effectively which should be addressed in line with the  Equality Act (2010) .

• Gather as much evidence as possible through questions, asking for descriptions, examples of behaviours, etc.
• Ensure you go through the risk process stage-by-stage jointly with the adult and/or carer, if they have capacity.
• Record appropriately the existing risks, their potential benefits and/or harms, their assessment and how they will be managed, including if the adult and/or carer is taking responsibility – if there is capacity – of the potential harms to themselves.
• Ensure you have a person-centred and risk enabler approach.

Don’t:

• Make assumptions – the existence of a risk factor or indicator does not mean there is a risk.
• Allow your threshold for risk to draw you to conclusions.
• Underestimate the potential benefits of taking a risk.

Clarke, C.L., Wilkinson, H., Keady, J. & Gibb, C.E. (2011) Risk assessment and management for living well with Dementia, Jessica Kingsley Publishers

Cooper, B. (2011) ‘Criticality and reflexivity: best practice in uncertain environments’, in Seden, J., Matthews, S., McCormick, M. and Morgan, A. (eds) Professional Development in Social Work: Complex Issues in Practice, London, Routledge, pp. 17-23

Kemshall, H. (2009), Working with sex offenders in a climate of public blame and anxiety: How to make defensible decisions for risk, Journal of Sexual Aggression, 15:3. 331-343

Morgan, S. (2004) ‘Positive risk-taking: an idea whose time has come’ Health Care Risk Report, 10(10), pp.18-19

Further reading

Risk identification, assessment and management – positive risk-taking.

• Guides on ethics, risk assessments and virtual meetings  (Social Work England, 2020)
• Independence, choice and risk: a guide to best practice in supported decision making  (Department of Health, 2007)
• Managing risk positively: A guide for staff in health and social care  (Isle of Wight Council)
• Nothing ventured, nothing gained day  (summary slides) (Moriarty, J and Manthorpe, J, 2011)
• Nothing ventured, nothing gained: Risk guidance for people with dementia  (page 52) (Department of Health, 2010)
• Positive risk and shared decision-making  (Social Care Wales)
• Positive risk-taking policy  (Gateshead Council)
• Positive risk-taking policy  (Lancashire County Council Adult and Community Services)
• Positive risk-taking policy: Easy read version  (Cumbria Learning Disability Services)
• The common core principles to support self-care – A guide to support implementation  (Skills for Care, 2015)

Personal hygiene

• Dignity in care: Personal hygiene  (video) (SCIE, 2015)
• Social workers must address service users’ poor hygiene  (Community Care, 2011)
• Are you at risk of falling?  (NHS England, 2018)
• Falls – risk assessment  (NICE, 2019)
• What are the main risk factors for falls amongst older people and what are the most effective interventions to prevent these falls?  (WHO (Europe), 2004)

Malnutrition

• Assessing nutritional risk  (Royal Wolverhampton NHS Trust, 2016)
• Malnutrition: What you need to know (Medical News Today)
• 10 symptoms of carer stress – and how to beat them  (LiveBetterWith, 2020)
• Caregiver burnout  (Cleveland Clinic, 2019)
• Care stress and burnout  (Helpguide, 2020)

Social isolation

• Causes of social isolation in elderly adults  (Griswold Home Care, 2020)
• Do you recognise the early signs of social isolation?  (Mort, A)
• Recognising the signs of isolation  (Where You Live Matters)
• Signs and symptoms of chronic loneliness  (Cigna)
• Social isolation: symptoms and signs  (MedicineNet)
• Quiz – signs of social isolation  (UCLA Loneliness scale)

Hoarding and environmental neglect

• Clinical assessments for hoarding  (International OCD Foundation)
• Hoarding disorder  (NHS England, 2018)
• Hoarding: The basics  (Anxiety and Depression Association of America)
• Professional practice note: Hoarding and how to approach it, guidance for Environmental Health Officers and others  (Chartered Institute of Environmental Health, 2004)
• What is hoarding disorder?  (American Psychiatric Association, 2017)

Safeguarding

• COVID-19 and safeguarding adults: frequently asked questions  (LGA and ADASS, 2020)
• Guidance for safeguarding adults during Covid-19 pandemic: addendum: safeguarding adults in placements (BASW, 2020)
• Professional practice guidance for safeguarding adults during COVID-19 pandemic  (BASW, 2020)

Self-neglect

• Risk assessment and management of patients whom self-neglect: a ‘grey area’ for mental health workers  (Journal of Psychiatric and Mental Health Nursing. Volume 10, Issue 3, pages 287–296, June 2003)
• Self-neglect at a glance  (SCIE, 2018)

Development and Validation of a Nomogram for Predicting Nutritional Risk Based on Frailty Scores in Older Stroke Patients

• Original Article
• Open access
• Published: 18 May 2024
• Volume 36 , article number  112 , ( 2024 )

Cite this article

You have full access to this open access article

• Lei Liu 1 ,
• Chunyu He 1 ,
• Jiaxin Yang 1 ,
• Wenbo Chen 1 ,
• Yan Xie 1 &
• Xiaofang Chen 1  

In older stroke patients with frailty, nutritional deficiencies can amplify their susceptibility, delay recovery, and deteriorate prognosis. A precise predictive model is crucial to assess their nutritional risk, enabling targeted interventions for improved clinical outcomes.

To develop and externally validate a nutritional risk prediction model integrating general demographics, physical parameters, psychological indicators, and biochemical markers. The aim is to facilitate the early identification of older stroke patients requiring nutritional intervention.

This was a multicenter cross-sectional study. A total of 570 stroke patients were included, 434 as the modeling set and 136 as the external validation set. The least absolute shrinkage selection operator (LASSO) regression analysis was used to select the predictor variables. Internal validation was performed using Bootstrap resampling (1000 iterations). The nomogram was constructed based on the results of logistic regression. The performance assessment relied on the receiver operating characteristic curve (ROC), Hosmer–-Lemeshow test, calibration curves, Brier score, and decision curve analysis (DCA).

The predictive nomogram encompassed seven pivotal variables: Activities of Daily Living (ADL), NIHSS score, diabetes, Body Mass Index (BMI), grip strength, serum albumin levels, and depression. Together, these variables comprehensively evaluate the overall health and nutritional status of elderly stroke patients, facilitating accurate assessment of their nutritional risk. The model exhibited excellent accuracy in both the development and external validation sets, evidenced by AUC values of 0.934 and 0.887, respectively. Such performance highlights its efficacy in pinpointing elderly stroke patients who require nutritional intervention. Moreover, the model showed robust goodness of fit and practical applicability, providing essential clinical insights to improve recovery and prognosis for patients prone to malnutrition.

Conclusions

Elderly individuals recovering from stroke often experience significant nutritional deficiencies. The nomogram we devised accurately assesses this risk by combining physiological, psychological, and biochemical metrics. It equips healthcare providers with the means to actively screen for and manage the nutritional care of these patients. This tool is instrumental in swiftly identifying those in urgent need of targeted nutritional support, which is essential for optimizing their recovery and managing their nutrition more effectively.

Avoid common mistakes on your manuscript.

Introduction

Cerebrovascular events, commonly known as strokes, are characterized by acute neurological deficits due to localized or generalized cerebral tissue ischemia or hemorrhage. These neurological disruptions carry significant clinical implications for the affected individuals [ 1 ]. Statistics from the World Health Organization reveal that strokes impact approximately 15 million people worldwide every year, with a sobering 5.8 million resulting in death. These figures position strokes as the leading cause of disability and the second primary cause of death globally [ 2 ]. There is an undeniable escalation in the prevalence and associated disabilities of strokes, most saliently among the geriatric population—defined in this context as individuals aged 60 years and older. This upsurge detrimentally bears upon their life expectancy and overall quality of life. A nexus of physiological deficits, augmented disease severity, and psychological afflictions often fosters reduced resilience and augmented susceptibilities in stroke survivors, frequently converging to a state of frailty. The ramifications of this state are particularly trenchant among the old, critically impeding their functional rehabilitation and overall well-being [ 3 ]. In gerontological paradigms, frailty is emblematic of a marked functional regression, and it is inextricably associated with a spectrum of detrimental sequels. These encompass instances like inadvertent falls, functional debilitations, recurrent hospital readmissions, and an elevated risk of mortality [ 4 ]. Recent research insights delineate a significant correlation between frailty and nutritional status. In older adults, nutritional risk factors are closely associated with the decline in muscle mass and strength, directly influencing the onset and progression of frailty. This muscle loss significantly impacts their physical functionality, raising the risk of falls and contributing to other health challenges such as depression and cognitive decline. Aznar-Tortonda et al. emphasize the need for early detection of frailty, which can identified by physical parameters like muscle strength, a key aspect highlighted in the FRAIL scale. This connection between muscle loss and frailty underscores the importance of monitoring nutritional health to prevent frailty in older adults [ 5 , 6 ]. These factors also serve as risk determinants for the onset of frailty. Patients exhibiting frailty often present with pronounced malnutrition, which, in turn, can exacerbate the frail condition, creating a vicious cycle [ 7 ]. Consequently, the prognostication and intervention pertaining to nutritional risks in frail individuals are of paramount importance. Such strategies not only ameliorate the nutritional quality of life of patients but also impede the progression of frailty, diminishing the likelihood of unfavorable outcomes. At present, various nutritional risk assessment instruments—including the Subjective Global Assessment (SGA), Nutritional Risk Screening 2002 (NRS 2002), and Malnutrition Universal Screening Tool (MUST)—have gained widespread adoption [ 8 , 9 ]. However, the specificity and sensitivity of these tools in catering to the nuanced characteristics and requisites of frail older stroke survivors, particularly those inhabiting the Asia-Pacific region, remain contentious. Therefore, devising a nutritional risk predictive model tailored specifically for frail older stroke patients holds paramount clinical significance. By adeptly identifying individuals within this high-risk bracket, such a model can substantially enhance their clinical management and prognosis, offering both pragmatic implications and scholarly merit.

Materials and methods

Participants.

Using a convenience sampling method, we selected stroke inpatients from Class A tertiary hospital (It is a medical institution classified in accordance with the provisions of China's current "Hospital Classification and Management Measures", and is the highest level in the "three levels and six grades" classification of hospitals in mainland China.) in Chengdu who met the inclusion and exclusion criteria. We favored this sampling method for its efficiency in recruiting a specific patient population amidst resource constraints, offering a more direct and time-efficient approach compared to other methods.

The inclusion criteria included: (1) aged ≥ 60 years, meeting the diagnostic criteria for cerebrovascular disease from the Fourth National Conference [ 10 ], diagnosed by CT, and have a confirmed stroke diagnosis via MRI scans; (2) we reviewed the patient’s medical records and consulted with physicians to confirm that the patients did not have aphasia or dementia, could communicate effectively, and were willing to participate in the study; (3) FRAIL scale score ≥1; and (4) informed and voluntarily willing to participate in the study (Written informed consent was obtained from the patients themselves. In situations where the patient was unable to sign due to physical or cognitive limitations, their direct relatives provided consent, ensuring the patient's understanding of the study).

The exclusion criteria included: (1) patients with transient ischemic attack; (2) patients who underwent emergency surgery or received thrombolytic therapy; (3) presence of other severe comorbidities including but not limited to malignant tumors, significant hepatic or renal dysfunction, major trauma, respiratory failure, severe arrhythmia, frequent angina, heart failure, and myocardial infarction; (4) those who received enteral or parenteral nutritional support before their hospital admission; and (5) history of severe psychiatric symptoms.

Questionnaires that contained clear logical errors, had missing scale content, or exhibited outliers after data processing would be excluded.

Sample Size

Based on the predictive model sample size calculation proposed by Riley et al. [ 11 ], the study required a sample size ranging from 378 to 423 cases. Accounting for a potential 10% of ineffective cases, the minimum sample size was set at 416. The actual study included 434 cases. For a detailed description of the sample size calculation formula and method, see Supplementary Method S1.

Variable Selection

Predictive variables for the nutritional risk of stroke patients were identified through a literature review, group discussions, and consultations with experts in the fields of neurology and nutrition. The final set of variables selected for collection included: (1) Demographics: sex, age, educational level, marital status, family monthly income, stroke type, comorbidity of chronic diseases, consumption of ≥3 prescription medications, history of smoking, alcohol consumption, and falls. (2) Laboratory indicators such as albumin, total protein, triglycerides, cholesterol, and hemoglobin. These were sourced from the patient's medical records and the laboratory test results from the day of the assessment. If no tests were conducted on the assessment day, the most recent laboratory results prior to the assessment date were used. (3) Body Mass Index (BMI) calculation, measurements of upper arm circumference, triceps skinfold thickness, calf circumference, waist circumference, hip circumference, and mid-upper arm muscle circumference. (4) Utilized the National Institutes of Health Stroke Scale (NIHSS) which consists of 15 items, with a total score ranging from 0 to 42. Scores are categorized as: 0–1 divided into normal or near-normal, 2–4 in mild impairment, 5–15 in moderate impairment, and >15 in severe impairment. (5) The Barthel index is used to assess the ADL of patients. Includes 10 aspects, non-dependence 100 points, mild dependence 61 to 99 points, moderate dependence 41 to 60 points, and gravity dependence ≤40 points. (6) Depression is assessed using the Geriatric Depression Scale (GDS-15). It consists of 15 items with a maximum score of 15. Scores are interpreted as: 0 to 4 for normal, ≥5 indicative of depression. A higher score indicates more severe depression symptoms.

Frailty assessment

The FRAIL scale, endorsed by experts in care for older individuals from the International Association of Nutrition and Aging (IANA) and grounded in established frailty criteria and indices [ 12 ], consists of five straightforward self-reported questions addressing fatigue, resistance reduction, ambulation, illness, and weight loss. The scale totals a maximum of 5 points: scores of ≥3 indicate frailty, 1–2 suggest pre-frailty, and a score of 0 represents robustness or non-frailty.

Nutritional Risk Definition

The NRS-2002 is recommended by the European Society for Parenteral and Enteral Nutrition (ESPEN) [ 13 ] and is used to assess nutritional risks in adult inpatients. This tool has been proven to possess strong validity and reliability in prospectively gauging shifts in a patient's nutritional status. The scale consists of three distinct segments: the degree of influence of disease on nutritional status (up to 3 points), the level of malnutrition (comprehensive evaluation of changes in weight over the past 3 months, changes in dietary intake over the last 1 week and BMI values, up to 3 scores) and the age score (at 1 point for the age of ≥70 years). Cumulatively, these scores have a maximum total of 7. A score of ≥3 implies that a patient is at nutritional risk, while scores below 3 signify no immediate nutritional peril.

Data Collection Methodology

This study received ethical approval from the Ethics Committee of Chengdu Medical College (Approval number: 2022NO.22) and adheres to the principles set out in the Helsinki Declaration. Prior to participation, all participants furnished informed consent. General demographic details and the aforementioned scores were gathered on the day of admission, while laboratory indicators were extracted directly from the patient's medical records. To uphold the integrity of the data, trained investigators administered one-on-one, on-site questionnaire surveys. In situations where patients were unable to provide answers independently, their spouses or legal guardians were interviewed instead.

Data Preprocessing

Variables with missing values were removed to ensure data integrity. Outliers were identified using the Interquartile Range (IQR) method, and data entries with illogical anomalies were discarded. Such outliers typically arise from input errors or measurement inconsistencies and deviate significantly from the overall data distribution. To maintain the authenticity of the dataset while adjusting for unit differences, the data were standardized. For clinical applicability, BMI was transformed into a binary classification, but all other data remained in its original format.

Statistical Analysis

Data were input into Excel and then double-checked for accuracy, with corrections made as required. Data analysis was conducted using IBM SPSS Statistics 26.0 (IBM Corp., Armonk, NY) and R version 4.3.0 (R Foundation for Statistical Computing, Vienna, Austria). The specific methodologies employed included: (1) Count data were represented using rates and composition ratios. Measurement data that followed a normal distribution were described using the mean ± standard deviation. Non-normally distributed data were represented using the median and interquartile range. (2) The Chi-squared test and Fisher's exact test were applied to assess distribution differences for categorical variables. Ranked data differences between groups were analyzed using the Wilcoxon rank-sum test. The Mann–Whitney U test was used for non-normally distributed data. A p -value less than 0.05 was deemed statistically significant. (3) Preliminary factor screening for predictions was done using LASSO regression. The optimal penalty coefficient for the model was chosen based on the lambda value that corresponded to the cross-validated error within one standard deviation of the minimum error. Following this, a binary logistic regression analysis of variables filtered by the LASSO regression was conducted to discern the final predictors and construct a nomogram model; (4) Model discrimination was assessed with the Bootstrap-based Area Under the Curve (AUC). Model calibration was examined through the Hosmer–Lemeshow goodness-of-fit test, calibration plots, and the Brier score. The model's clinical utility was further evaluated using a Decision Curve Analysis (DCA) conducted with the rmda package in R.

1Participant Characteristics

A total of 570 patients were included in this study. Of these, 434 were allocated to the development set, while 136 served as the external validation set. The incidence of nutritional risk was 49.5% in the development set and 51.4% in the external validation set. The average age of patients in the development set was 72.03 years, with an age range of 60 to 90 years. For the external validation set, the average age was 70.53 years, spanning an age range of 60 to 89 years. The basic characteristics and univariate analysis results of the modeling set are presented in Table  1 . Details pertaining to the external validation set can be found in Supplementary material Table S1 .

In this analysis, nutritional risk presence served as the dependent variable. Statistically significant factors identified from the univariate analysis were integrated into the LASSO regression. A tenfold cross-validation, along with minimization criteria, was employed to ascertain the optimal coefficient λ (Fig.  1 a, b). The outcomes revealed that at a λ value of 0.056, seven variables were discerned with non-zero coefficients. These encompassed daily living activity capability, NIHSS score, diabetes, BMI, grip strength, serum albumin, and depression. The importance ranking of these variables can be found in Supplementary Figure S1 in the supplementary materials.

LASSO regression screened 7 potential out of 38 candidate variables. Note: (a) Displays the distribution of LASSO regression coefficients for 38 characteristics, producing a logarithm (lambda) sequence coefficient profile graph; (b) Two vertical dashed lines from left to right represent lambda.min and lambda.1se, respectively. Lambda.min corresponds to the λ value that results in the smallest estimated model error, while lambda.1se corresponds to the λ value where the internal cross-validation error is at its maximum within one standard deviation. By determining the optimal λ, seven non-zero coefficients are derived

Model Development

Based on the seven pivotal variables identified through the LASSO regression, and using the presence of nutritional risk as the outcome event, logistic regression was employed (Table  2 ). In utilizing this nomogram (Fig.  2 ), scores associated with each predictive variable are combined to derive a comprehensive score. This consolidated score can then be used to estimate the likelihood of a patient having nutritional risk. To illustrate, consider a hypothetical patient with a moderate dependency in ADL (accruing 32 points), an NIHSS score of 7 (22 points), presence of diabetes (11 points), a BMI of 18.1 kg/m 2 (38 points), grip strength measuring 15 kg (20 points), serum albumin concentration of 35 g/dL (58 points), and absence of depression (0 points). The patient's aggregate score would be roughly 181 points, corresponding to a 95% chance of experiencing nutritional risks.

Nomogram for predicting nutritional risk in frail older stroke patients

Internal and External Model Validation

Using R 4.3.0, the ROC curve for the predictive model was generated. Bootstrap resampling was executed with 1,000 iterations for internal validation of the model. The post-calibration AUC was determined to be 0.934 (95% CI: 0.909 to 0.959) as depicted in Fig.  3 a, indicating a good distinction capability of the model. The model's accuracy in the development set was recorded as 89.17%, with a specificity of 0.874. With a Brier score of 0.088 and complemented by the calibration plot (Fig.  4 a) and the Hosmer–Lemeshow test (χ 2  = 12.398, P = 0.13), the model's predictive precision was evident. Furthermore, the Decision Curve Analysis (DCA) demonstrated in Fig.  5 a revealed that the model's net benefit surpassed that of "treat all" or "treat none" strategies.

Roc curve of nutrition risk model in training and validating cohorts

Calibration curve of nutrition risk model in training and validating cohorts

DCA curve of nutrition risk predictive nomogram in training and validating cohorts

For external validation, 136 stroke patients seen between May and July 2023 were utilized. The AUC of the model was 0.887 (95% CI 0.822 to 0.953) and is presented in Fig.  3 b. A Brier score of 0.106 was noted, and the results of the Hosmer–Lemeshow test were χ 2  = 13.634, P = 0.092. The accuracy and specificity of the model were 86.76% and 0.914, respectively, indicating that the model performed well in its predictive efficacy in the external validation set. Both the calibration curve (Fig.  4 b) and DCA (Fig.  5 b) further affirmed the model's discriminating ability and clinical utility.

Elevated Nutritional Risk in older Stroke Patients with Frailty

Nutritional risk goes beyond merely observing the occurrence of malnutrition. It is characterized by current or prospective nutrition-related factors that might predispose a patient to clinical adversities. Unlike malnutrition, nutritional risks underscore the clinical implications of undernourishment, exhibiting a higher prevalence than mere malnutrition itself [ 14 ]. Research indicates that the prevalence of malnutrition and nutritional risks in stroke patients can vary significantly, influenced by factors such as sample characteristics, regional differences, and assessment methodologies. Cui et al. reported that the incidence of malnutrition among hospitalized patients with neurological disorders is approximately 10%, while the proportion at nutritional risk is around 20% [ 15 ]. In contrast, studies employing the Global Leadership Initiative on Malnutrition (GLIM) criteria have documented higher malnutrition rates, with 43% reported by Sato K et al. [ 16 ], and 35.2% by Kobayashi D et al. [ 17 ]. Additionally, Nozoe M et al., using the Geriatric Nutritional Risk Index (GNRI) to evaluate the nutritional status of elderly stroke patients, found a 13.0% incidence of malnutrition risk [ 18 ]. This study discerned a nutritional risk incidence rate of 49.5% in older stroke patients exhibiting frailty, and 51.5% in the external validation cohort. These figures markedly surpass prior findings, insinuating that stroke patients with functional impairments confront more adverse nutritional statuses.

The literature emphasizes that malnutrition and frailty often coexist in hospitalized geriatric stroke patients [ 19 , 20 ]. This concomitance not only perpetuates each condition but also culminates in a detrimental feedback loop, posing amplified health risks. Such mutual exacerbation might stem from shared pathophysiological underpinnings, with both conditions impinging upon seniors' autonomy, life quality, and healthcare expenditure. Frailty, typified by a decline in functional capacity, often manifests as weight loss, muscle atrophy, and diminished appetite. Concurrently, strokes can induce metabolic alterations in patients. Therefore, the concurrence of frailty with stroke elevates the predisposition to nutritional risks. Elevated nutritional risks might exacerbate age-associated muscle atrophy and diminished strength, potentially leading to functional incapacitation, mood disorders, falls, compromised immune response, and cognitive impairments, thereby intensifying frailty [ 21 ].

Both the attenuated phenotype model and the holistic frailty conceptual model integrate nutrition as a pivotal explanatory factor. Frailty undergoes a dynamic evolutionary trajectory. Timely recognition and intervention can potentially decelerate the progression of frailty. Given that nutrition remains a modifiable determinant in the trajectory of frailty development, the early identification and management of nutritional risks in frail older stroke patients are paramount. Such interventions not only enhance patient recovery and mitigate complications but also augment patients' quality of life.

Analysis of Pertinent Risk Factors

This study established a model encompassing ADL, NIHSS scores, diabetes, BMI, grip strength, serum albumin levels, and depression to forecast the nutritional risk in frail older stroke patients. Previous research has demonstrated a bidirectional relationship between ADL and nutrition, while the ability to perform daily activities can predict nutritional status, nutrition which, in turn, significantly influences one's daily functioning. A compromised ability to conduct daily tasks might signify challenges related to feeding and other activities, resulting in inadequate nutritional intake and potential deterioration of a patient's nutritional status [ 22 , 23 ]. Furthermore, reduced motor function can impact muscle mass and metabolic rate, elevating nutritional risk.

NIHSS scores serve as indicators of neural damage severity. Elevated scores suggest pronounced neurological deficits, which might compromise eating abilities due to issues like mastication and dysphagia. Severe cases often coincide with inflammatory responses and metabolic disturbances, exacerbating nutritional inadequacies [ 24 ].

Many stroke patients concurrently present with diabetes, potentially stemming from the stroke's impact on neuroendocrine systems. This can diminish insulin sensitivity and elevate insulin resistance risk [ 25 ]. Insulin resistance can attenuate cellular insulin responsiveness, interfere with protein synthesis and degradation, and amplify nutritional risk. Concurrently, it jeopardizes peripheral systems by promoting free fatty acid circulation and deposition into myocytes, leading to intramuscular fat accumulation and perturbed muscle metabolism [ 26 ].

Physiologically, metrics like BMI and grip strength correlate with nutritional risk, reflecting body fat, muscle mass, and muscular strength—essential parameters for nutritional evaluation [ 27 ]. Post-stroke muscle and weight loss are frailty hallmarks and diminished BMI and grip strength might signify muscle and adipose tissue loss. These phenomena might be underpinned by metabolic disorders, inflammatory responses, and reduced motor function, exacerbating nutritional inadequacies [ 28 ].

Serum albumin, a standard nutritional marker, encapsulates a patient's nutritional health and protein metabolism dynamics. Protein deficits in stroke patients, often manifesting as hypoalbuminemia, could arise from inadequate intake, nutrient malabsorption, metabolic anomalies, or inflammatory processes. Depleted serum albumin levels might catalyze muscle atrophy, immunodeficiency, and accentuated malnutrition [ 29 ].

Mental health intricacies, particularly depression, have emerged as pivotal determinants in our predictive model. Through rigorous data analysis, we discerned a salient association between depressive states and amplified nutritional risk—a nexus that finds resonance with the seminal work of Kunugi et al. [ 30 ]. Individuals afflicted with depression often grapple with exacerbated negative affective states, a psychological milieu that invariably culminates in anorexic tendencies, thus leading to suboptimal caloric and essential nutrient intake. Persistently compromised dietary regimens predispose these individuals to multifarious metabolic dysregulations, amplifying the perturbations in their nutritional equilibrium. Our proposed model, in its essence, embodies an interdisciplinary paradigm, melding salient physiological, psychological, and biochemical indices tethered to nutritional precariousness. Each constituent element, though discrete, operates within a sophisticated, interconnected matrix, collectively modulating the patient's nutritional milieu. As clinicians and researchers, our purview necessitates a nuanced, multifactorial approach. Crafting bespoke nutritional interventions mandates a meticulous appraisal of this intricate interplay of determinants. By adopting such a granular, targeted approach, we can usher in interventions that are not only tailored but also potentiated for maximal efficacy, heralding enhanced patient prognostics and a marked elevation in their post-interventional quality of life.

Generalizability and Clinical Utility of the Model

Leveraging frailty scores and utilizing LASSO regression for variable selection, this study constructed a linear predictive model to assess the nutritional risk in older stroke patients. The model's efficacy was substantiated through the analysis of the ROC curve, calibration curve, and clinical decision curve. The findings indicate that the developed Linear Prediction Model possesses commendable clinical discrimination, predictive accuracy, and practical utility.

Furthermore, this research incorporated external validation involving patients from diverse time periods. In the external validation cohort, the model exhibited consistent performance, suggesting notable generalizability. This predictive model equips clinical healthcare professionals with a practical tool for nutritional risk assessment. After brief training, they can use this model to forecast the nutritional risk in stroke patients, accounting for the comprehensive distribution of all delineated risk factors. This proactive approach facilitates early risk identification, enabling timely interventions. Such early actions can mitigate deteriorations in patients' quality of life and nutritional status during preliminary or post-onset therapeutic procedures.

Limitations

First, this study employed a cross-sectional design, which inherently restricts the exploration of profound causal relationships. Future research could benefit from a longitudinal design, enabling continuous monitoring and dynamic observation of variations in patients' nutritional risks and associated variables. Second, while the model has undergone both internal and external validation, its applicability might still be susceptible to several influencing factors, including geographical variations, patient demographics, and the specificities of disease presentations. Lastly, despite the model demonstrating promising results during the validation process, it necessitates additional assessments to ascertain its efficacy and practicality within real-world clinical settings.

The incidence of nutritional risk is notably elevated among frail older individuals who have suffered from strokes. This risk is intricately associated with various factors, including the capacity to perform daily activities (ADL), NIHSS scores, the presence of diabetes, BMI, grip strength, serum albumin, and depression. By establishing a predictive model anchored on frailty scores, healthcare professionals can more precisely pinpoint patients at heightened risk. Such identification paves the way for tailored nutritional intervention strategies, essential for enhancing nutritional status, facilitating rehabilitation, and ultimately augmenting the quality of life for these older stroke patients.

Data availability

The data generated during this study are subject to third-party restrictions and therefore are not publicly available. The data were used under license for the current study, and so are not accessible. Further inquiries can be directed to the corresponding author.

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Acknowledgements

The work was supported by the Department of Science and Technology of Sichuan Province [20ZDYF2400], the Sichuan Nursing Association's Nursing Research Project (NO: H22014), the Joint Research Fund of Chengdu Medical College and the Second Affiliated Hospital of Chengdu Medical College (NO: 2022LHFSSYB-07), and the Graduate Student Research Innovation Fund of Chengdu Medical College (No: YCX2022-01-45). The authors extend their heartfelt gratitude to all participants and other stakeholders who contributed to the success of this study.

Department of Science and Technology of Sichuan Province (20ZDYF2400), Sichuan Nursing Association's Nursing Research Project (No: H22014), Joint Research Fund of Chengdu Medical College and the Second Affiliated Hospital of Chengdu Medical College (No: 2022LHFSSYB-07) and the Graduate Student Research Innovation Fund of Chengdu Medical College (No: YCX2022-01-45).

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Lei Liu, Chunyu He, Jiaxin Yang, Wenbo Chen, Yan Xie & Xiaofang Chen

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All procedures performed in studies involving human participants in this article were in accordance with the ethical standards and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. No animal studies were carried out by the authors for this article. This study has been approved by the Ethics Committee of Chengdu Medical College (Approval number: 2022NO.22).

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Liu, L., He, C., Yang, J. et al. Development and Validation of a Nomogram for Predicting Nutritional Risk Based on Frailty Scores in Older Stroke Patients. Aging Clin Exp Res 36 , 112 (2024). https://doi.org/10.1007/s40520-023-02689-0

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DOI : https://doi.org/10.1007/s40520-023-02689-0

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Venous Thromboembolism Risk Assessment Models for Acutely Ill Medical Patients—Back to the Drawing Board?

• 1 King’s Thrombosis Centre, Department of Haematological Medicine, King’s College Hospital NHS Foundation Trust, London, United Kingdom
• 2 Institute of Pharmaceutical Sciences, Faculty of Life Sciences and Medicine, King’s College London, London, United Kingdom
• Original Investigation Risk Assessment Models for VTE in Medical Inpatients Emmanuel Häfliger, MD; Basil Kopp; Pauline Darbellay Farhoumand, MD; Damien Choffat, MD; Jean-Benoît Rossel, PhD; Jean-Luc Reny, MD, PhD; Drahomir Aujesky, MD, MSc; Marie Méan, MD; Christine Baumgartner, MD, MAS JAMA Network Open

Hospital-associated venous thromboembolism (HA-VTE) remains a major public health issue, affecting an estimated 10 million patients per year. 1 The first step in prevention of HA-VTE is identifying patients at risk to appropriately prescribe thromboprophylaxis. Häfliger et al 2 evaluate the performance of 4 published risk assessment models (RAMs) for estimating risk of VTE in a prospectively recruited cohort of acutely ill medical patients from 3 Swiss hospitals from 2020 to 2022. Of 1352 patients with a median length of stay of 7 days (IQR, 5-11 days), with 51.6% receiving thromboprophylaxis on admission, 2.1% developed symptomatic VTE by 90 days. Data required for risk assessment were collected independently by study personnel to allow for categorization into groups at high risk and low risk of VTE using the original Geneva, simplified Geneva, Padua, and IMPROVE (International Medical Prevention Registry on Venous Thromboembolism) RAMs. The accuracy and discrimination of all studied tools were suboptimal, with the original Geneva model being the most sensitive (82.1%) and the IMPROVE model being the most specific (70.4%). The area under the receiver operator characteristic curve for all models ranged from 53.8% to 58.1%, highlighting the poor discrimination of the models and leading the authors to question their utility in clinical practice.

The use of VTE risk assessment at hospital admission is advocated to (1) identify patients at high VTE risk, enabling targeted thromboprophylaxis; (2) minimize the risk of bleeding in patients at low VTE risk; and (3) improve cost-effectiveness. A previous systematic review supports the findings of Häfliger et al 2 of weak predictive performance, 3 such that one RAM could not be recommended over another. However, there is evidence that the use of RAMs enhances provision of thromboprophylaxis, 4 with a systematic review of 13 randomized clinical trials of interventions to improve thromboprophylaxis reporting that alerts not only significantly improved the use of appropriate thromboprophylaxis by 16% (95% CI, 12%-20%) but also reduced hospital-associated thrombosis (relative risk reduction, 64% [95% CI, 47%-86%]). 5 In England, the implementation of mandatory VTE risk assessment (using a nonvalidated tool) of all patients admitted to the hospital, as part of a national VTE prevention program, was associated with a 16.2% reduction in postdischarge VTE-related mortality. 6

Häfliger et al 2 highlight the challenges with existing RAMs, particularly in evaluating predicted immobility. Immobility is a highly weighted component of all 4 RAMS, albeit with varying definitions between scores for a prespecified time of 3 to 7 days. They propose the use of accelerometers as a more objective measure of immobility, but this measure would still not allow for the assessment of the duration of immobility at the time of admission. A move to risk assessment with risk factors identifiable at admission has been proposed by Zakai and colleagues. 7 They developed and externally validated a new RAM for VTE prediction for medically ill patients comprising 7 risk factors readily available at hospital admission (active cancer, malnutrition, history of VTE, low hemoglobin level, increased creatinine level, hyponatremia, and increased red blood cell distribution width). 7 This model performed well in 3 external cohorts and warrants further evaluation.

In the present study, the use of thromboprophylaxis for 51.6% of patients at the clinician’s discretion is acknowledged as a limitation, and subgroup analysis of those not receiving thromboprophylaxis supported the overall study findings. Although no RAM was incorporated into electronic order sets, all participating sites had guidelines suggesting the use of either the Padua score or the simplified Geneva score. The undocumented use of these RAMs and clinical gestalt is likely to have influenced prescribing, along with concerns for bleeding risk (which is not incorporated into the VTE RAMs evaluated). We noted the low uptake of mechanical thromboprophylaxis (1.6%), possibly due to limited evidence to support their use, and that 10% of this cohort were considered at high risk of bleeding in an earlier publication. 8 The timing of HA-VTE is not reported in this study; previous studies suggest that two-thirds of HA-VTE occurred after hospital discharge. Venous thromboembolism risk factors at hospital discharge may differ from those collected at admission, and as noted by the authors, many participants had persistent VTE risk factors, including being older than 60 years of age (62.6%), obesity (19.9%), and active cancer (19.5%), which are associated with a higher persisting risk of VTE. The selection of patients who may benefit from extended duration or intensified regimens of thromboprophylaxis remains a research priority.

We congratulate Häfliger et al 2 on their important contribution to understanding the limitations of current strategies to evaluate VTE risk among acutely ill medical patients and agree that further study of VTE risk assessment models is warranted. In addition, emerging anticoagulant agents with a potentially lower bleeding risk, such as the factor XI inhibitors, are of great interest, and we anticipate the future evaluation of such agents in this patient group. In the interim, pragmatic selection of a VTE risk assessment model at the hospital (or national) level as a means for embedding a systematic approach to VTE prevention remains essential to improve patient safety.

Published: May 10, 2024. doi:10.1001/jamanetworkopen.2024.9952

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2024 Roberts LN et al. JAMA Network Open .

Corresponding Author: Roopen Arya, BMBCh(Oxon), MA, PhD, King’s Thrombosis Centre, Department of Haematological Medicine, King’s College Hospital NHS Foundation Trust, Denmark Hill, London SE5 9RS, United Kingdom ( [email protected] ).

Conflict of Interest Disclosures: Dr Roberts reported receiving personal fees from Chugai and Hemab outside the submitted work. Dr Arya reported receiving personal fees from Sanofi and Cardinal Health outside the submitted work. No other disclosures were reported.

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Roberts LN , Arya R. Venous Thromboembolism Risk Assessment Models for Acutely Ill Medical Patients—Back to the Drawing Board? JAMA Netw Open. 2024;7(5):e249952. doi:10.1001/jamanetworkopen.2024.9952

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