research paper on medical negligence

Medical negligence in healthcare organizations and its impact on patient safety and public health: a bibliometric study

Affiliations.

• 1 Department of Environmental Health, College of Public Health, Imam Abdulrahman Bin Faisal University, Dammam 31441, P.O. Box 1982, Saudi Arabia.
• 2 Forensic Medicine Division, Department of Pathology, College of Medicine, Imam Abdulrahman Bin Faisal University, Dammam 31441, P.O. Box 1982, Saudi Arabia.
• 3 Deanship of Library Affairs, Imam Abdulrahman Bin Faisal University, Dammam 31441, P.O. Box 1982, Saudi Arabia.
• PMID: 34113436
• PMCID: PMC8156516
• DOI: 10.12688/f1000research.37448.1

Background : Medical negligence is an increasing public health concern among healthcare providers worldwide as it affects patient safety. It poses a significant risk of patient injury, disease, disability, or death. The WHO has recognized deficiencies in patient safety as a global healthcare issue to be addressed. This study aimed to analyze various components of medical negligence research literature. Methods : Bibliographic data visualizations tools like Biblioshiny (RStudio) and VOSviewer were used besides MS Excel to examine the types of documents, annual scientific production, top contributing authors and their impact, authorship patterns and collaboration, top contributing countries and organizations, most significant sources of publication, most cited documents, and most frequently used keywords. Bibliometric methods were used to analyze the bibliographic records of research output on medical negligence downloaded from the Web of Science Core Collection. Results : The annual productivity of medical negligence research was increasing gradually. The most productive period for medical negligence research was 2011-2020. Bird contributed the highest number of publications to medical negligence literature while Brennan emerged as the highly cited author. Single-authored publications on medical negligence were not highly cited. The United States was the highest contributing country and the University of South Florida was the highest contributing organization while Harvard University was a highly cited organization. Nine out of the top ten contributing organizations were academic institutions and most of them belonged to the United States. The most important sources of publication on this topic were The Lancet and British Medical Journal. Localio et al . was the most important research article on medical negligence research. Conclusion : Due to increasing attention on this topic, there was a sharp increase in the research output on medical negligence. This is of significance as the WHO set in motion a patient safety program almost two decades ago.

Keywords: Medical negligence; bibliometric; medical errors; medical malpractice; patient safety; scientometric.

Copyright: © 2021 Dahlawi S et al.

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• Malpractice*
• Patient Safety
• Public Health*
• United States

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Malpractice Liability and Health Care Quality

Michelle m. mello.

Stanford Law School, Stanford University School of Medicine, Stanford, CA

Department of Medicine, Stanford University School of Medicine, Stanford, CA

Michael D. Frakes

Duke Law School

Erik Blumenkranz

David m. studdert, associated data.

The tort liability system is intended to serve three functions: compensate patients who sustain injury from negligence, provide corrective justice, and deter negligence. Deterrence, in theory, occurs because clinicians know that they may experience adverse consequences if they negligently injure patients.

To review empirical findings regarding the association between malpractice liability risk (i.e., the extent to which clinicians face the threat of being sued and having to pay damages) and healthcare quality and safety.

Data sources and study selection

Systematic search of multiple databases for studies published between January 1, 1990 and November 25, 2019 examining the relationship between malpractice liability risk measures and health outcomes or structural and process indicators of healthcare quality.

Data extraction and synthesis

Information on the exposure and outcome measures, results, and acknowledged limitations was extracted by 2 reviewers. Meta-analytic pooling was not possible due to variations in study designs; therefore, studies were summarized descriptively and assessed qualitatively.

Main outcomes and measures

Associations between malpractice risk measures and healthcare quality and safety outcomes. Exposure measures included physicians’ malpractice insurance premiums, state tort reforms, frequency of paid claims, average claim payment, physicians’ claims history, total malpractice payments, jury awards, the presence of an immunity from malpractice liability, the Centers for Medicare and Medicaid Services’ Medicare Malpractice Geographic Practice Cost Index, and composite measures combining these measures. Outcome measures included patient mortality; hospital readmissions, avoidable admissions, and prolonged length of stay; receipt of cancer screening; Agency for Healthcare Research and Quality Patient Safety Indicators and other measures of adverse events; measures of hospital and nursing home quality; and patient satisfaction.

Thirty-seven studies were included; 28 examined hospital care only and 16 focused on obstetrical care. Among obstetrical care studies, 9 found no significant association between liability risk and outcomes (such as Apgar score and birth injuries) and 7 found limited evidence for an association. Among 20 studies of patient mortality in non-obstetrical care settings, 15 found no evidence of an association with liability risk and 5 found limited evidence. Among 7 studies that examined hospital readmissions and avoidable initial hospitalizations, none found evidence of an association between liability risk and outcomes. Among 12 studies of other measures (e.g., Patient Safety Indicators, process-of-care quality measures, patient satisfaction), 7 found no association between liability risk and these outcomes and 5 identified significant associations in some analyses.

Conclusions and Relevance

In this systematic review, most studies found no association between measures of malpractice liability risk and healthcare quality and outcomes. Although gaps in the evidence remain, the available findings suggested that greater tort liability, at least in its current form, was not associated with improved quality of care.

The medical liability system is intended to serve three functions: compensate patients injured by negligence, promote corrective justice by providing a mechanism to rectify wrongful losses caused by defendants, and deter negligence. 1 Deterrence is the notion that liability can make healthcare safer. Theoretically, clinicians will respond to the threat of being held liable for malpractice. Because evidence suggests that the tort system performs poorly as a means of providing patients with compensation for injuries related to negligence 2 and rarely provides meaningful corrective justice, 2 , 3 a belief in deterrence motivates many defenders of the tort system. 4

Whereas deterrence leads clinicians to calibrate safety responses so that the costs do not exceed the benefits, a related phenomenon, defensive medicine, reflects responses that are costly and provide little or no clinical benefit. Evidence of defensive medicine is common, 5 whereas evidence of deterrence is more elusive. The standard approach in deterrence studies is to compare levels of healthcare quality across environments with relatively high and low liability risk. This approach cannot evaluate what healthcare quality would be like in the absence of liability risk, but can reveal whether the extent of liability risk is related to health care outcomes.

Does malpractice liability risk—that is, the extent to which clinicians face the threat of being sued and having to pay damages—contribute to improvements in the quality and safety of healthcare? The question is relevant to assessing the role of the liability system in the patient safety movement. Because malpractice litigation might inhibit error disclosure, clinicians may view tort litigation as counterproductive to quality improvement; 6 yet, legal practitioners view injury prevention as one of the fundamental functions of tort law. The question matters for tort reform efforts, as skepticism about the deterrent effect of malpractice litigation reinforces arguments that liability can be limited without risking the quality of care.

The objective of this systematic review was to evaluate the association between malpractice liability risk and healthcare quality and safety, and thereby assess the evidence for deterrence as it relates to clinicians.

Search Strategy and Study Eligibility

We performed a systematic review in July 2018 of articles published or otherwise made public from January 1, 1990 to July 10, 2018; results were subsequently updated with an additional search through November 25, 2019. The search protocol was registered on PROSPERO ( https://www.crd.york.ac.uk/prospero/ , number CRD42018103723) and is provided in sections S1 and S2 of the Supplemental Appendix . We searched 5 databases (Web of Science, MEDLINE/PubMed, Westlaw, EconLit, and SSRN) using combinations of keywords related to liability risk (e.g., malpractice, liability, tort, deter, negligence, defensive, litigation) and measures of health-related outcomes (e.g., outcome, quality, safety, care, deter, patient) (exact strings for each database provided in Supplemental Appendix section S3 ). For example, the search string used for Web of Science was “TI=(malpractice OR liab* OR tort OR deter OR deterren* OR negligen* OR defensive OR litigation) AND TS=(physician OR doctor OR hospital OR clinic OR provider OR practitioner) AND TS=(quality OR safety OR deter* OR outcome OR care OR patient) AND CU=(USA)”. We also examined the bibliographies of relevant articles for citations to additional papers, and included relevant working papers known to us through conference presentations and personal contacts with colleagues; together these methods added 5 studies to the sample.

After eliminating duplicate articles, we reviewed the articles retrieved and applied prespecified inclusion criteria. These criteria identified original empirical studies of the association between indicators of malpractice liability risk and indicators of healthcare quality and safety that used study approaches (e.g., multivariable regression analysis) designed to address potential sources of confounding. To identify healthcare quality measures, we used the Donabedian framework 7 and included measures of structure, process, and outcomes that unambiguously reflect good or poor quality care. Thus, services such as prenatal care and receiving beta blockers after myocardial infarction met our criteria (process), as did nurse staffing ratios (structure). Studies that examined the relationship between liability risk and measures that are more reflective of costs than quality were not included. For these reasons, studies focusing on caesarean deliveries and most types of diagnostic tests were excluded. Such services are considered overutilized, due in part to defensive medicine. Unless studies accounted for clinical circumstances that distinguished appropriate from inappropriate use (for example, separating elderly from young patients in examining screening mammography 8 ), they were deemed unhelpful in assessing deterrence. If a study examined multiple outcome measures, we included only analyses of outcomes that met our criteria.

Each study was reviewed for potential inclusion by 1 reviewer. When review of the title and abstract alone was insufficient to reach a decision about the eligibility of the study for inclusion, the full text was reviewed. If the reviewer remained uncertain as to whether a study met inclusion criteria, all 3 reviewers reviewed the full text of the study and resolved the issue through discussion.

To update the search results prior to publication of this review, supplemental searches using the same protocol with date range July 2018 to November 25, 2019 were performed.

Data Extraction and Synthesis

For each eligible study, we extracted into an Excel spreadsheet information on the authors, year published or released, exposure measures, outcome measures, data sources, sample size, level of analysis (patient, facility, physician, or geographic unit), results (direction and magnitude of association with malpractice risk variables), authors’ conclusions, and acknowledged limitations. The reported findings were considered to be in the direction of deterrence if greater liability risk was associated with better outcomes, whereas reported findings were considered to be in an anti-deterrence or reverse deterrence direction if greater liability risk was associated with worse outcomes. Study type is not reported because all but one study (a case-control analysis of emergency physicians) 9 took the same basic approach of using multivariable regression analysis to examine a retrospective sample of one or more years of data.

Meta-analytic pooling was not possible due to variations in study features, especially the large number of different exposures and outcome measures modeled. Consequently, studies were summarized descriptively. We characterized as statistically significant those associations reported in the sampled studies that achieved the 0.05 significance level, except that we used significance levels corrected for multiple comparisons for studies that reported them. To avoid replicating possible bias in study authors’ selective emphasis of particular study results, we examined tables of regression results rather than relying on summaries from the study authors.

Quality Assessment

Because of the nature of the study designs, it was not possible to use existing instruments to assess the risk of bias in research. Existing tools for assessing observational studies (for example, Newcastle-Ottawa and ROBINS-I) were designed for clinical and epidemiologic studies, and no comparable tool is used in the field of econometrics. For that reason, we performed an independent, qualitative risk-of-bias assessment, summarizing the strengths and weaknesses of the study. To ensure rigor, each article was reviewed by 2 team members with training in econometrics who were not involved in the study being evaluated. In addition to extracting limitations acknowledged by the study authors, reviewers noted strengths and weaknesses pertaining to the data source (e.g., sample size, population covered, range of covariates incorporated, usefulness of measures, whether the data could support individual-level models), model estimation methods (e.g., identification strategy, control for confounders, potential endogeneity, robustness checks), and any concerns about the accuracy of the study authors’ characterizations of the study findings.

Study Characteristics

The original search identified 1949 unique studies as potentially eligible for inclusion; 1821 of these were screened out after review of the article title and abstract and another 128 were deemed ineligible after review of the full text ( Figure 1 ; details in Supplemental Appendix section S3 ). Thirty-three studies met our inclusion criteria, 4 of which were unpublished. The supplemental update search added 4 eligible studies. Selected characteristics of the final sample of 37 studies are presented in Table 1 and additional details are in Supplemental Appendix eTable 2 .

Study Identification and Selection

Selected Characteristics of the 37 Studies Included in the Qualitative Synthesis a

Abbreviations: MI, myocardial infarction; IHD, ischemic heart disease; PSI, Agency for Healthcare Research and Quality Patient Safety Indicator; RN, registered nurse; ADL, activities of daily living; UTI, urinary tract infection; CHD, coronary heart disease; VTE, venous thromboembolism; PSA, prostate-specific antigen; HCAHPS, Hospital Consumer Assessment of Healthcare Providers and Systems.

All studies used multivariable regression analysis to assess the association between the exposure and outcome variables in a longitudinal or cross-sectional sample. Because studies varied in their unit of analysis, from patient or physician to county, region, or state, the number of observations per study ranged from 50 to more than 132 million ( Table 1 ). For example, Dhankhar and Khan 10 analyzed 100 state-year observations and Yang et al. 11 analyzed 2,354,561 births.

Exposure Measures

The studies measured the extent of malpractice liability risk in a given environment in several ways ( Table 1 ). Physicians’ malpractice insurance premiums and the presence of liability-limiting tort reforms in the state were the most common exposure measures (n=21 studies). Other measures included the frequency of paid claims in the state or county (n=13), insurance premiums (n=7), average payment per paid claim (n=8), physicians’ claims history (n=5), total malpractice payments in the state or county (n=2), jury awards in the county (n=1), immunity from malpractice liability (n=1), the Centers for Medicare and Medicaid Services’ (CMS) Medicare Malpractice Geographic Practice Cost Index (MGPCI) (a measure of premium costs to physicians in local liability insurance markets) (n=1), and composite measures incorporating more than one of the foregoing (n=3). Data sources for exposure measures included the National Practitioner Data Bank (a national repository of information on paid malpractice claims), insurance industry rate surveys, the Centers for Medicare and Medicaid Services, jury awards databases, and 50-state summaries of state legal reforms.

Outcome Measures

Outcome measures included patient mortality; hospital readmissions, avoidable admissions, and prolonged length of stay; receipt of cancer screening services; Agency for Healthcare Research and Quality Patient Safety Indicators (PSIs) and other measures of adverse events and postoperative complications; measures of hospital and nursing home quality; and patient satisfaction (see Table 1 for measures used in each study). Three quarters of the studies (28/37) focused on hospital care only, and nearly half (16/37) focused on obstetrical care. Studies outside the obstetrics context commonly measured associations between liability risk and patient mortality, although more recent studies examined associations with PSIs. Data sources for outcome measures included Medicare and other claims data, vital statistics records, physician practice group databases, cancer registries, and surveys.

Evidence Relating to Obstetrical Care

Of the 16 studies examining obstetrical care, 9 identified no significant associations between liability risk and quality in the direction of deterrence ( Table 2 ). Seven studies found limited evidence of associations, i.e., the statistical significance, direction, or both of the associations were sensitive to the model specification used, the patient group studied, or the outcome measure examined.

Studies Examining Associations Between Malpractice Liability Risk Measures and Obstetrical Care, 1990–2019 (n=16) a

PSI = Patient Safety Indicator; JSL = joint-and-several liability rule reform; CSR = collateral-source offset rule reform

Several studies found no significant association between liability measures and outcomes in the direction of deterrence. Entman et al 12 found that obstetricians’ personal history of malpractice claims was not associated with quality of care or frequency of adverse events. Three studies using malpractice premiums as the exposure measure found no associations with Apgar scores, low birthweight, preterm birth, or birth injury. 11 , 13 , 14 In a study of military physicians, who are immune from malpractice litigation related to their care of active-duty servicemembers (but not other patients), Frakes and Gruber 15 found no association between immunity and several adverse birth outcomes (preventable delivery complications, neonatal mortality, neonatal trauma, and maternal trauma in vaginal deliveries). Two studies by Dubay et al 13 , 14 found that tort reforms were not associated with prenatal health care utilization, low birthweight, or Apgar scores. Frakes 16 also found no association between tort reforms and Apgar scores. Frakes and Jena 17 did not find tort reforms to be associated with any of several obstetrical PSIs. Kim 18 found neither claim frequency nor average claims payments were associated with prenatal care utilization or use of cesarean delivery in patients with breech presentation. Malak and Yang 19 found no association between tort reforms and infant mortality or preventable birth complications.

Several studies identified limited evidence of an association between liability measures and outcomes in the deterrence direction. Sloan et al 20 found a significant association between liability risk and birth outcomes in the direction of deterrence in 2 of 23 models tested. In county-level analyses using survey data, both claim frequency and total claims payments were associated with reduced risk of fetal mortality. However, these associations did not achieve statistical significance in physician-level models, and neither liability measure showed significant associations with any of the other 4 outcome variables (low Apgar score, 5-day neonatal mortality, infant mortality, or death or permanent impairment at age 5) in any model. In analyses using a larger sample of county birth records, no associations between liability risk measures and birth outcomes were significant at the p<0.05 level.

A subsequent study by Sloan et al 21 found claim frequency to be significantly associated with prenatal care utilization in the direction of deterrence in 1 of 8 models tested. In physician-level models, claim frequency was significantly associated with greater use of alpha-feto protein tests, but not with greater use of ultrasound or diabetes tests. The relationship between claim frequency and use of amniocentesis was significant in the direction opposite of deterrence (i.e., claim frequency was associated with less use of amniocentesis). In county-level models, no significant associations were observed between claim frequency and any of 4 measures of patient satisfaction (doctor is interested in your and your baby, doctor fully explained the reason for each test and procedure, doctor ignored what you told him/her, and you felt you could call doctor with questions).

Dhankhar and Khan 10 also examined claim frequency, along with mean payment amounts per paid claim. Among 56 models (in which patients with Medicaid coverage and those with private insurance, and births involving necessary and unnecessary cesarean sections, were analyzed separately), 53 models found no significant associations with the 7 birth outcomes examined. Two models found a significantly lower risk of neonatal respiratory distress among patients with private insurance and unnecessary c-sections. One model found a reverse deterrence association (i.e., increased claim frequency was associated with an increased risk of neonatal respiratory distress) for Medicaid patients with necessary c-sections.

Three studies that examined tort reforms also found no evidence of an association between liability risk and health outcomes in the direction of deterrence in most models. Klick and Stratmann 22 studied 7 tort reforms in relation to mortality among black and white infants (modeled separately) and found no significant deterrence associations in 25 of 28 models. Only collateral-source rule reform (which consists of deducting from plaintiffs’ malpractice awards amounts already reimbursed by insurance and other sources) was consistently associated with mortality across model specifications in the direction of deterrence (i.e., tort reform was associated with increased infant mortality), although this association was observed only among black infants. Joint-and-several liability reform (which consists, in cases involving multiple defendants, of limiting the damages each must pay to an amount proportional to that defendant’s percentage fault for the injury) was associated with increased mortality for white infants in 1 of 2 model specifications, but was not significant in either model specification for black infants. Two models produced reverse deterrence findings, i.e., greater liability was associated with worse outcomes. Currie and Macleod studied 4 tort reforms in relation to preventable birth complications and low Apgar scores, and found that noneconomic damages caps were associated with an increase in the preventable complication rate but were not associated with Apgar score. Joint-and-several liability reform was associated with a decrease in preventable complications, which is a reverse deterrence finding because that reform limits defendants’ liability. There was no significant association between joint-and-several liability reform and low Apgar score, or between the other tort reforms examined (punitive damages caps and collateral-source rule reform) and either of the outcomes. Iizuka 23 examined 4 tort reforms and 4 birth-related PSIs, modeling them at both the hospital and patient levels, and found that only collateral-source rule reform was significant in a direction consistent with deterrence, and only in hospital-level models that examined injuries to neonates (2.36 more injuries per hospital-year when collateral-source rule reform was implemented to reduce liability, p<0.01) and mothers (5.7 more injuries per hospital-year, p<0.05); neither of those associations was significant in the patient-level models.

In an analysis that examined the relationship between noneconomic damages caps and 3 PSIs plus a pooled PSI, Zabinski and Black 24 found more consistent associations in the direction of deterrence across model specifications, but only for maternal outcomes. In a model examining all states, the coefficient was significant and positive (i.e., in the direction of deterrence) for the pooled measure and 1 PSI (representing a 7% increase in the rate of maternal trauma in vaginal deliveries when noneconomic damages were capped), but not for the other 2 PSIs (neonatal injury and maternal trauma in deliveries without instruments). In single-state models, the association between noneconomic damages caps and outcomes was significant for the pooled measure and 1 PSI in 4 of 5 states, significant in 1 state for 1 PSI, and significant in 2 states for the other PSI.

Overall, studies found very limited or no evidence of associations between liability risk and outcomes in obstetrical care that indicate deterrence. The variations in findings were not clearly correlated with the choice of either the exposure measure or the outcome measure, although only 1 of the 6 studies that examined mortality as an outcome found any evidence of an association.

Evidence Concerning Patient Mortality

Twenty studies examined the relationship between liability risk and patient mortality (in settings other than obstetrical care) and 15 found no statistically significant associations in the direction of deterrence ( Table 3 ). Three studies reached different conclusions about deterrence depending on the liability measure modeled and states investigated, 24 – 26 and 2 studies yielded less equivocal evidence of deterrence. 27 , 28

Studies Examining Associations Between Malpractice Liability Risk Measures and Patient Mortality in Non-Obstetrical Contexts, 1990–2019 (n=20) a

MI = myocardial infarction; IHD = ischemic heart disease; CHD = coronary heart disease; CMS = Centers for Medicare and Medicaid Services

Of the 15 studies that reported no significant associations between liability measures and mortality in the deterrence direction, 9 used tort reforms as the measure of liability risk and 6 used claim frequency, average payment per paid claim, jury awards, or other measures ( Table 3 ). These studies were also diverse in the patient populations studied, ranging from narrowly defined disease groups (e.g., patients with bladder cancer, 29 patients undergoing cranial neurosurgery 30 ) to wide patient populations (e.g., all Medicare patients 31 , 32 ).

Two of the 3 studies that found limited evidence of deterrence used tort reforms as the measure of liability risk. Zabinski and Black 24 focused on noneconomic damages caps and found no significant deterrence relationships in 14 of 18 models tested, including all models that pooled data from more than one state. In 2 of 5 single-state models, damages caps were significantly associated with higher mortality for 2 of the 3 mortality measures (one individual PSI and a measure pooling 2 death PSIs). Shepherd 26 modeled 6 tort reforms and found that 2 (total damages caps and collateral-source rule reform) were significantly associated with state-level, non-motor-vehicle-related deaths in the direction of deterrence (i.e., deaths increased when liability was limited), whereas 2 (noneconomic damages caps and punitive damages reform) were significantly associated with mortality in a reverse-deterrence direction (deaths decreased when liability was limited), and 2 (periodic payment and joint-and-several liability reform) had nonsignificant results. A study by Dhankhar et al 25 that used claim frequency and average payments per paid claim as the liability risk measures found that an increase in the number of paid claims by one case per 100,000 population was associated with a statistically significant, 13% lower risk of in-hospital mortality among patients with myocardial infarction, but found no association between mean payment amounts and mortality.

Two studies found more consistent evidence of an association between liability risk and outcomes in the direction of deterrence. Lakdawalla and Seabury 27 estimated that a doubling of a county’s jury award dollars per capita in malpractice cases was associated with a 2% decrease in the county’s all-cause mortality rate; this is a surprisingly large effect size considering that only a small fraction of deaths were due to medical injury. Bilimoria et al 28 examined 3 measures of liability risk in a model of 30-day mortality for hospitalized patients with myocardial infarction, heart failure, and pneumonia. The authors found that claim frequency was not significantly associated with mortality, although higher Medicare Malpractice Geographic Practice Cost Index was significantly associated with lower mortality for all 3 conditions, and a composite liability measure was significantly associated with lower mortality for patients with heart failure. However, most studies found no evidence of an association between higher liability risk and lower patient mortality.

Evidence Relating to Avoidable Hospitalizations and Readmissions

Six studies examined the relationship between liability risk and hospital readmissions and a seventh examined associations with avoidable hospitalizations ( Table 4 ). All 6 studies found no significant association between liability risk and readmissions, despite testing diverse liability measures and patient populations ranging from narrow (e.g., patients undergoing colorectal surgery 33 ) to broad (e.g., patients seeing military physicians 15 ). In an analysis of avoidable hospitalizations, Frakes and Jena 17 found no significant association between 4 tort reforms (noneconomic damages caps, punitive damages caps, collateral-source rule reform, and joint-and-several liability reform) and hospital readmissions. 17

Studies Examining Associations Between Malpractice Liability Risk Measures and Readmissions and Avoidable Hospitalizations, 1990–2019 (n=7) a

MI = myocardial infarction; IHD = ischemic heart disease; CMS = Centers for Medicare and Medicaid Services

Evidence Concerning PSIs and Postoperative Complications

Six studies examined the association between liability risk and rates of PSIs or other measures of postoperative complications outside the obstetrical care context ( Table 5 ). Of these, 4 studies found no evidence of deterrence, 15 , 30 , 33 , 34 1 found evidence in only a small number of the many models included in the study, 28 and 1 found evidence in the majority of models tested. 24

Studies Examining Associations Between Malpractice Liability Risk Measures and Other Outcomes, 1990–2019 (n=12) a

PSI = patient safety indicator; CMS = Centers for Medicare and Medicaid Services; HCAHPS = Hospital Consumer Assessment of Healthcare Providers and Systems.

The variation in results across studies is not clearly attributable to the choice of exposure or outcome measures. 28 However, although the 4 studies that found no significant association between liability risk measures and health outcomes included a wide range of liability measures (claim frequency, average payments, premiums, legal immunity, and composite measures), none used tort reforms as the exposure measure. The study that reported limited evidence of deterrence, Bilimoria et al, 28 included tort reforms as an exposure measure and concluded there was no “consistent pattern of association” with 5 PSIs across the reforms (quantitative results were not reported). The same study found, in 15 other models testing the association of 3 other types of liability measures with each of the 5 PSIs, that findings were significant in the deterrence direction in 2 models (MGPCI and iatrogenic pneumothorax; and MGPCI and unintentional punctures/lacerations). Two models had significant results in the reverse deterrence direction, and 11 other models found no significant association between liability measures and outcomes.

A study by Zabinski and Black, 24 which tested noneconomic damages caps only, was an outlier in terms of findings, and identified evidence of deterrence in most (62/93) models tested. For example, in models that pooled multiple PSIs and all states, the authors found that caps were associated with a 0.16 percentage point increase in the incidence of any PSI (p<0.05) and a 0.04 percentage point increase in the incidence of operating room PSIs (p<0.05). The findings concerning deterrence were relatively consistent across pooled models, but were mixed for models of individual PSIs and single states.

Overall, most studies found that higher liability risk was not associated with improved performance on PSIs or decrease rates of postoperative complications.

Evidence Relating to Other Quality Measures

Two studies investigated the relationship between liability risk and rates of clinically appropriate cancer screening ( Table 5 ). Baicker and Chandra 8 identified significant associations between liability risk and mammography rates in models using mean malpractice claim payments as the exposure measure, but no significant associations in models using claim frequency or insurance premiums. Frakes and Jena 17 found no relationship between tort reforms and cancer screening rates.

Three studies examined process-of-care measures of quality ( Table 5 ). The study by Bilimoria et al 28 of 17 Hospital Compare measures found no significant associations in the direction of deterrence between the state malpractice environment and process-of-care quality measures. Stevenson et al 35 examined the relationship between a nursing home’s claims experience and 9 process and outcome measures of quality and also found no significant deterrence relationships. In analyses of nursing home quality, Konetzka et al 36 found a significant association in a deterrence direction in 1 of 3 models. Claim frequency was significantly associated with a more favorable ratio of registered nurse to total staffing hours, although the effect size was small (2.4% increase in the ratio for a 1-standard-deviation increase in claim frequency).

Two studies found no significant association between liability risk and patient satisfaction, although a third study found evidence of deterrence ( Table 5 ). Sloan et al 21 found no relationship between claim frequency and obstetrical patients’ satisfaction ratings, and Bilimoria et al 28 found that MGPCI, claim frequency, tort reforms, and a composite measure were not associated with Hospital Consumer Assessment of Healthcare Providers and Systems ratings. However, Carlson et al 9 found that emergency physicians who experienced a claim had significantly higher patient experience scores after the claim was filed (increase of 6.52 in Press Ganey percentile rank, 95% CI 0.67–12.38).

Qualitative Risk-of-Bias Assessment

Study-specific assessments of risk of bias are provided in Supplemental Appendix eTable 2 . Although the quality of these articles could not be assessed using standard quality assessment tools, the methodological assessment we conducted revealed that, with few exceptions, 10 , 25 , 26 most studies included in this review used appropriate analytical methods, including good controls for confounding and exploration of the robustness of results to changes in model specification. The varied study results were not evidently attributable to the choice of measures, analytic approaches, or sample sizes. Although all of the studies in this review have limitations, none can be dismissed as methodologically unsound. The study that had outlier findings, Zabinski and Black, 24 did not have obvious weaknesses other than its narrow focus on noneconomic damages caps.

However, the quality assessment identified several methodological limitations that may affect the ability of some studies to accurately measure the extent and nature of associations between the exposure and outcome measures. First, a general limitation of the evidence base examined is that all studies but one 15 examined that extent of change in the outcome measures when liability risk was higher versus lower, rather than the absolute effect associated with tort liability risk. Second, although studies that examined what happened during hospitalization may find no evidence of deterrence, it is possible that liability risk affects inpatient mix. In areas with high liability risk, physicians who are concerned about liability might be more inclined to admit to the hospital patients whose need for hospitalization is less clear (i.e., these patients may be healthier than other admitted patients on average). After tort reform is passed, there may be lower tendency to admit such patients, in which case the average admitted patient would have higher severity of illness and be more prone to poor outcomes. The most likely consequence of such selection effects would be spurious positive findings of deterrence; they are less likely to invalidate null findings.

Third, in some studies that used tort reforms as the exposure measure, only a few states adopted reforms during the study period. For example, in the study by Zabinski and Black 24 only 5 states changed their noneconomic damages caps laws in the years studied. In such circumstances, regression estimates may have low precision and be subject to confounding by unobserved, time-varying effects. 37

Fourth, some analyses may have unexplored problems of two-way causation. For instance, adverse events are an established risk factor for malpractice claims. 36 , 38 , 39 A regression model that evaluates the relationship between adverse event rates and claim frequency without accounting for this cannot support the kind of causal inference a firm conclusion about deterrence requires.

Fifth, some studies relied on state- or county-level outcomes data. For instance, Klick and Stratmann 22 used state infant mortality rates, Baicker and Chandra 8 used state-level mammography rates for Medicare patients, Shepherd 26 used state mortality rates for non-motor-vehicle accidents, and Lakdawalla and Seabury 27 used county all-cause mortality rates. Drawing causal inferences with such measures can be problematic because group aggregation reduces information and may mask important differences between individuals in the group. 40

Sixth, aggregation was also common in construction of exposure variables. Most studies measured liability risk indicators at the state or county level, rather than the level of the individual physician, and no studies measured physicians’ perceived levels of liability risk. Physicians may have different awareness of and reactions to such environmental indicators, making physician-level analyses preferable. More studies should examine whether particular physicians change their clinical behavior after they have been sued and, ideally, parse sued physicians according to the subjective intensity of their liability experience.

Seventh, some studies were narrow in focus. Kessler and McClellan 41 , 42 examined only patients hospitalized with 2 cardiac conditions; Konety et al 29 focused solely on patients with bladder cancer; Avraham and Schanzenbach 43 only studied deaths due to coronary heart disease; Missios and Bekelis 44 only included patients who had spine surgery; Bekelis et al 30 focused on patients who had undergone cranial neurosurgery; and Bilimoria et al 33 only included patient who had colorectal surgery. Findings from these distinct analyses may or may not replicable in broader samples.

This review of 37 studies of malpractice deterrence conducted since 1990 found that most studies suggest that higher risk of malpractice liability is not significantly associated with improved healthcare quality. Studies that examined obstetrical care were most likely to have identified some significant associations, but even in that domain there was inconsistency across analyses, including analyses within the same study, and most analyses did not identify evidence of deterrence. Notwithstanding some methodological shortcomings, collectively this body of evidence is sufficient to support a conclusion that higher tort liability risk was not systematically associated with safer or higher-quality care in the hospital setting. Because only a limited number of studies addressed care delivered in other settings, it is not possible to draw conclusions about deterrence in those clinical contexts.

In theory, the deterrence effect of malpractice liability risk could proceed through three mechanisms. The first is economic: malpractice claim payments impose a direct financial sanction. Most physicians are well insured for malpractice 45 and awards rarely exceed coverage limits, 46 but physicians may experience economic effects if their insurance premiums increase or their medicolegal track record adversely affects their clinical income. 47 Healthcare facilities may be affected by economic sanctions more readily than physicians because their insurance generally involves greater experience rating, meaning that premiums are determined in part based on how costly the facility’s claims were in a prior period. The second mechanism (which is less applicable to healthcare facilities) is that the psychological stress and trauma of litigation can be severe, and physicians will endeavor to avoid experiencing them. 48 , 49 The third mechanism is informational. Not all malpractice claims are meritorious, but some convey information about deviations from standards of care. Individual clinicians, healthcare facilities, health insurers, and regulators may then respond to those signals in ways that may prevent harm.

Our systematic review suggests that notwithstanding these theoretical mechanisms, malpractice liability risk may not be effective in preventing substandard care. One possible explanation relates to the etiology of medical error. Some errors involve momentary or inadvertent lapses at the individual clinician level. 50 , 51 Although hospitals might be able to implement systems to identify some such errors before they cause harm, other errors are not amenable to the kind of conscious precaution taking (at either the hospital or the physician level) on which the deterrence model relies.

Previous reports have identified 3 other problems, which have continuing relevance. 45 The first (and perhaps largest problem) is that most instances of medical negligence that cause harm never become malpractice claims, whereas many claims of uncertain or no merit are filed. The poor fit between claims and negligence introduces noise into the deterrent signal, reinforcing physicians’ perceptions that claims do not convey valid information about their quality of care.

Insurance is a second contributing factor. Unlike causing a motor vehicle crash, causing a malpractice injury does not ordinarily result in higher insurance premiums for the involved individual. It is actuarially difficult for insurers to apply experience rating at the physician level, so paid claims do not tend to manifest as direct economic sanctions for the physician. This is less of a problem at the facility level, where self-insurance and experience rating are common.

A third issue is uncertainty about the legal standard of care. Physicians complain that they do not know what “negligence” is—i.e., precisely what the law requires in a given clinical situation. Such uncertainty may contribute to undercutting the desired behavioral change.

Policy levers exist that could address these problems. For example, adopting enterprise liability, a reform that shifts the primary locus of liability from individual practitioners to larger organizations such as hospitals or accountable care organizations, would be helpful. 45 Organizations experience the economic aspect of deterrence more strongly than physicians because they are sued more often and have experience-rated insurance. 45 Organizations are also better positioned to effectuate changes in care that transcend individual practitioners. Another pertinent lever would be widespread implementation of communication-and-resolution programs (CRPs), through which healthcare facilities disclose adverse events to patients, rapidly investigate them, and offer proactive compensation when deviations from the standard of care have caused harm. 52 These programs could result in a higher proportion of negligent events receiving compensation, thereby reinforcing the economic and psychological mechanisms of deterrence. Further, under CRPs, injuries that are not due to negligence are less likely to become claims because facilities explain to patients what happened; preventing such claims strengthens the informational function of litigation because claims more reliably point to actual quality problems.

Limitations of the Systematic Review

This systematic review has several limitations. First, because studies of deterrence in the malpractice context are published in journals in a wide range of disciplines, there is a risk that some studies were missed. To minimize this risk, we searched multiple databases spanning the medical, public health, economics, business, and legal literatures. Second, some articles reported incomplete or vague information. Articles varied in the amount of detail provided about the data sources, data years analyzed, and model estimation methods employed. Additionally, some did not report full quantitative results for some models, and articles varied in how quantitative results were reported (e.g., with beta coefficients or odds ratios). Third, some articles reported the results of a very large number of different models and model specifications (for example, one reported 84 models 34 ). These circumstances complicated our effort to summarize studies and provide quantitative results that are interpretable and comparable across studies. Fourth, no validated instrument was available for assessing quality or risk of bias in studies of the type included in this review; consequently, this assessment has greater subjectivity than is optimal.

Conclusions

Is greater risk of malpractice liability associated with better quality of care?

In this systematic review of 37 studies of obstetrical care outcomes, patient mortality, hospital readmissions, avoidable hospitalizations, and other measures, statistically significant associations between liability risk and quality-related outcome measures were rarely observed. Most studies focused on inpatient care.

Most studies in this review found no association between greater risk of malpractice liability and healthcare quality.

Supplementary Material

Supplemental appendix, acknowledgments.

Dr. Frakes reported support from the National Institute on Aging, grant R01-AG049898. Dr. Studdert reported receiving grants from the Stanford University Medical Indemnity and Trust Insurance, which is wholly owned by Stanford Hospital and Clinics and Lucile Packard Children’s Hospital. Dr. Mello had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis. The data analysis was performed by M.M., M.F., E.B., and D.S.

Contributor Information

Michelle M. Mello, Stanford Law School, Stanford University School of Medicine, Stanford, CA. Department of Medicine, Stanford University School of Medicine, Stanford, CA.

Michael D. Frakes, Duke Law School.

Erik Blumenkranz, Stanford Law School, Stanford University School of Medicine, Stanford, CA.

David M. Studdert, Stanford Law School, Stanford University School of Medicine, Stanford, CA. Department of Medicine, Stanford University School of Medicine, Stanford, CA.

• Research article
• Open access
• Published: 25 April 2018

The struggle against perceived negligence. A qualitative study of patients’ experiences of adverse events in Norwegian hospitals

• Gunn Hågensen   ORCID: orcid.org/0000-0002-8332-5083 1 ,
• Gudrun Nilsen 1 ,
• Grete Mehus 1 &
• Nils Henriksen 2  

BMC Health Services Research volume  18 , Article number:  302 ( 2018 ) Cite this article

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A Correction to this article was published on 14 March 2019

This article has been updated

Every year, 14 % of patients in Norwegian hospitals experience adverse events, which often have health-damaging consequences. The government, hospital management and health personnel attempt to minimize such events. Limited research on the first-hand experience of the patients affected is available. The aim of this study is to present patients’ perspectives of the occurrence of, disclosure of, and healthcare organizations’ responses to adverse events. Findings are discussed within a social constructivist framework and with reference to principles of open disclosure policy.

This qualitative study with an explorative descriptive design included fifteen in-depth interviews with former patients recruited by the Health and Social Services ombudsmen in the two northernmost counties of Norway. Inclusion criteria were as follows: 1) experience of adverse events in connection with surgical, orthopedic or medical treatment in general hospitals; 2) men and women; 3) aged 20–70; and 4) a minimum of one year since the event occurred. Transcribed audio-recorded interviews were analyzed through qualitative content analysis.

The analysis revealed three main topics regarding patients’ experiences of adverse events: 1) ignored concerns or signs of complications; 2) lack of responsibility and error correction; and 3) lack of support, loyalty and learning opportunities. Patients had to struggle to demonstrate the error that had occurred and to receive the necessary treatment and monitoring in the aftermath of the events.

Conclusions

Patient narratives reveal a lack of openness, care and responsibility in connection with adverse events. Conflicting power structures, attitudes and established procedures may inhibit prevention, learning and patient safety work in spite of major efforts and good intentions. Attitudes in day-to-day patient care and organizational procedures should be challenged to invite patients into open disclosure processes and include them in health and safety work to a greater extent. The study’s small sample of self-selected participants limits the generalizability of the findings, and future studies should include a larger number of patients as well as professional perspectives.

Peer Review reports

Illness and health problems shock people out of their natural rhythm by placing their life and health at risk [ 1 ]. People utilize health services to regain their health and welfare to the greatest extent possible and expect that their care will be performed in a safe and beneficial manner. Norway’s health service is considered high quality. However, calculations show that 13–14% of patients experience adverse events (AEs) from hospital treatments [ 2 ], and this value corresponds to international figures found in recent decades [ 3 ]. The World Health Organization (WHO) has defined an AE as “An injury related to medical management, in contrast to complications of disease. Medical management includes all aspects of care, including diagnosis and treatment, failure to diagnose or treat, and the systems and equipment used to deliver care” [ 4 ]. Patients are affected by AEs in two different ways: partly by the injury itself and partly by the hospital’s responses before, during and after the incident [ 5 , 6 ].

In line with increasing international focus on the issue of AEs, Norwegian public investigations and consultations have indicated the need to develop a culture guided by principles of open disclosure in the health service. Key elements of such a culture include care for patients and their families after an injury, documentation of organizational responsibility, registration and reporting systems, investigations of undesirable incidents, systems for measuring patient safety and risk, and the involvement of patients and their families [ 7 , 8 ]. Legislation has included internationally recognized principles of open disclosure [ 9 ] to ensure that injured patients receive information and help with follow-up care after incidents have occurred [ 10 ]. The Norwegian Ministry of Health and Care Services emphasizes the increasing need to account for patient perspectives in the planning and implementation of patient treatment as well as in systematic quality and safety activities [ 11 ].

Thus far, hospital responses to AEs have been deficient. An Australian study based on “100 patient stories” found a lack of open disclosure and follow-up after the occurrence of AEs [ 12 ]. These findings corroborate an American study of cancer patients’ views on apologies and open disclosure when an error occurs [ 13 ] and studies of injured patients from the UK [ 14 , 15 ]. All of these results suggest a lack of recognition of patients’ need for an explanation of the event that has occurred, acceptance of responsibility, corrective apologies and initiation of measures to prevent the occurrence of similar incidents in the future. This issue is identified as the “disclosure gap” [ 16 ] or the “disclosure dilemma” [ 17 ]. Research has suggested that clinicians often avoid openness to protect their professional integrity and prevent personal consequences of an emotional, career or legal nature [ 17 , 18 ]. A publication from the Harvard Medical Practice Study III concluded that “Medical-malpractice litigations infrequently compensates patients injured by medical negligence and rarely identifies, and holds providers accountable for, substandard care” [ 19 ].

To date, patient safety activities and research on AEs have largely followed a system-based and biomedical perspective [ 20 ], which has been subject to critique as a top-down approach that often excludes patient voices from patient safety research and programs [ 21 ]. Within the sociotechnical systems tradition, the Systems Engineering Initiative for Patient Safety represents a person-centered model that incorporates human factors and stands out as an alternative to more limited traditional approaches [ 22 ]. However, the authorities and health personnel appear to have prioritized clinical, efficiency-related, financial and legal perspectives [ 23 , 24 ].

Scholars have critiqued these perspectives for potentially obscuring a range of social processes that affect AEs [ 14 , 20 ], and have argued for closer investigation of the multiple perspectives and different versions of events that may exist [ 25 , 26 ]. Ocloo states that it is time to re-identify the challenges and recognize the experiences of harmed patients as essential to patient safety efforts [ 14 ].

Clinical practice evolve through developments in medical research and interactions and negotiations between people who act within specific organizational frames that shape through professional, scientific and political discourses and the enactment of power [ 27 , 28 , 29 , 30 ]. These discourses and processes define the context, content of and responses to AEs and patient injuries. Extended patient safety discourses should include how professional power and control affect the articulation of patient experiences [ 15 ].

Patients possess power in the form of knowledge of their own body and health issues. However, the balance of strength and power remain askew. From a social constructivist [ 31 ] and interactionist [ 32 ] perspective, the rules of situations and settings in which social practices unfold are frames that influence actors’ behaviors. How patients perceive and interpret these frames may contribute to a broader understanding of how encounters are constructed and how power is exercised in hospitals when AEs occur.

Patient perspectives have largely been investigated using survey questionnaires with predefined questions and limited opportunities for patients to provide detailed accounts of their experiences [ 33 ], while in-depth interviews, which provide more detailed knowledge, have rarely been used [ 12 , 13 , 14 ]. First-hand accounts can provide authentic perspectives that illustrate patients’ experiences. The aim of this article is to illuminate conditions surrounding AEs from the patient perspective. Key aspects include how patients perceive the occurrence of events and the responses from health personnel and the health service.

Study design and setting

This qualitative study with an explorative descriptive design is part of an independent Ph.D. project entitled Experiencing an Adverse Event and Life Afterwards . The researchers have a background in nurse education, nursing and healthcare research and sociology and are affiliated with the UiT, The Arctic University of Norway. Individual open-ended interviews were considered an appropriate method for collecting data to capture complementary thick descriptions from patients about their experiences of AEs. Explorative designs allow participants an opportunity to emphasize important issues narrated from their own perspectives [ 34 ]. An in–depth interview is a professional conversation that seeks deep information and understanding of lived experiences from the interviewee’s perspective [ 35 , 36 ].

Recruitment and the sample

In Norway, The Health and Social Services ombudsman in each county can support patients and clients who experience AEs or insufficient help for their needs. The ombudsmen in the two northernmost counties Troms and Finnmark receive approximately 430 complaints related to hospital care each year [ 37 ], and were asked to assist in recruitment of study participants. As a statistical generalization was not an issue, we instructed the ombudsmen to obtain a varied sample. They performed a non-random search in their archives using the following inclusion criteria: adults between 20 and 70 years; both male and female; experience of AEs attached to surgical, orthopedic or medical treatment at general hospitals; and at least one year had passed since the event, allowing sufficient time for participants to reflect on and process the event. For qualitative in-depth studies, 10–25 interviews are considered sufficient to provide adequate data related to the research question [ 34 ].

The ombudsmen posted sixty invitation letters that included information sheets and informed consent forms that were all prearranged by the first author. The researcher did not participate in the recruitment process until the informed consent forms arrived by mail. Participants were contacted via telephone, and interviews were arranged based on their preferences.

A total of 19 former patients responded to the invitation. Two of these patients chose not to participate because they had enough trouble caused by the event, one had moved to a different geographical area, and one was unable to focus on the event during the interview. Thus, the study included fifteen participants, nine females and six males, ranging from 43 to 70 years old (median = 61 years). The incidents had occurred across three local hospitals and one university clinic in Northern Norway and one national hospital and one private clinic in Southern Norway. The interviews were conducted one to ten years after the AE, with an average of four years (median = 4 years). A maximum time limit was not set, as such a limit was viewed as a potential obstacle to recruiting a satisfactory number of participants. At the time of the interview, some of the informants were still undergoing treatment. All participants had experienced an injury as patients and approached the Health and Social Services ombudsman but had not necessarily claimed compensation from the Norwegian System of Patient Injury Compensation (NPE) (Table  1 ).

Data collection

The first author conducted individual interviews during the period from September 2013 to January 2014. Based on her experience with interview research and to position herself, she informed the participants that she had a background in nursing, that the study was independent and that she had no obligation toward the hospitals or to the Health and Social Services ombudsmen.

The conversations took place in the informants’ homes or in a desired meeting place. The first language of all participants was Norwegian, and the conversations were held in Norwegian. Each interview began with the open question: Please tell me what happened to you ..., and the participants were given an opportunity to speak as freely as possible to emphasize their own reflections and understandings. The researcher took a listening role and asked follow-up questions to increase the richness and depth of the stories [ 34 ]. A thematic interview guide formulated from findings of previous research [ 5 , 6 , 12 , 13 , 14 ] was used as a supporting document (see Additional file  1 ). ZxXThis guide served to ensure coverage of main themes across patient stories and to obtain more details about statements or topics if necessary [ 34 ]. Examples of follow-up questions include: What do you mean by that? Can you explain more about that? Side notes were written during the interviews. As no substantial new information appeared during the last interviews, the sample size was considered adequate for research purposes. The interviews lasted 45–150 min, were recorded as sound files and were transcribed to text by the first author. Expressions such as silences, sighs, laughter, crying, etc. were noted because they may influence the underlying meaning [ 38 ]. Eight of the participants released their discharge reports as supporting material.

Ethical considerations

Ethical considerations corresponding with the Helsinki declaration and national research regulations were made throughout the entire project [ 39 , 40 ]. After receiving oral and written information about the design and goals of the study, all participants provided their voluntary approval for participation and publication by signing an informed consent form. The participants were informed about their right to withdraw at any time, without stating a reason, and were guaranteed confidentiality and the anonymous presentation of findings. Fictitious names are used in the presentation of the results.

Data analysis

In qualitative research, analysis involves hermeneutic processes in which a pre-understanding derived from personal experience, former research and theoretical perspectives meets data and produces a deeper understanding and new concepts [ 38 , 41 ]. All text from the interviews (approximately 141,600 words) was subjected to the analysis, which was inspired by Graneheim and Lundman’s inductive model of qualitative content analysis [ 38 ] and supported by Malterud’s approach [ 34 ]. Our analysis addressed the manifest content aspects and describes the visible, obvious components in the texts as well as the latent underlying meaning based on interpretation. The texts were reread a number of times (GH and GN all interviews; NH 5 interviews) to gain an overall understanding and to generate preliminary categories.

Next, we made thematic categories and categorized the material in the texts that addressed the experiences related to the event itself. We then analyzed this material closely for the current paper. Statements related to the same central meaning were converted into condensed meaning units, which were coded and further interpreted and categorized as sub-topics and finally collected into main topics without use of qualitative software. The manifest content addressed the event that occurred, where and when it occurred, who was involved, how it was handled, and the patients’ perception of the event. Additionally, latent content, e.g. cover up , arose ‘unexpectedly’ or inductively from interview statements and was subject to interpretation. Coding and interpretations were checked against original transcripts. An example of this analysis is provided in Table  2 .

Trustworthiness of the data was achieved through reading the manuscripts multiple times and discussing themes in a series of meetings, and the three researchers’ independent generation of topics and themes. Discrepancies were resolved through several discussions until consensus was reached. The authors had different levels of experience with AEs from their professional and personal backgrounds. Reflexivity, practiced by noting biases and prior expectations, was an important piece of the analysis process to elicit the new understandings. The discharge reports were analyzed in light of whether the events were described and how they were presented. All the authors discussed the topics in light of relevant theory and achieved overall agreement. The following main topics emerged from the data (Table  3 ): ignored concerns or signs of complication; lack of responsibility and error correction; and lack of support, loyalty and learning. All study participants ( n  = 15) reported experiences that related to each of the three themes.

Descriptions of events

The findings concern AEs in various stages of the treatment chain and cover a wide range of basic illnesses and degrees of severity at the time of the event. A common feature among the fifteen study participants was that they experienced that something or someone had failed. The accounts represent many common denominators with regard to the overall sequence of events; reaction patterns; and patients’ perceptions of health personnel, the system, the care provided, and follow-up afterwards. Failures and defects are found in medical treatment but also in communication, information and documentation. Six of the events were related to failures and defects before treatment began. In these cases, the patients received a delayed or incorrect cancer diagnosis, which postponed the start of cancer treatment.

Various forms of cancer were represented: breast, prostate, kidney and stomach/colon. The informants assessed the causes of the events as follows: incorrect medical assessment of clinical signs and symptoms, failure of diagnostic tests, notices of appointments that were sent incorrectly or were missing or test results/referrals that were put aside for later examination but were not assessed. According to the informants, the delays resulted in an increased spread of cancer; more severe complications, resulting in more complicated treatment regimens; and mental stress. The informants mentioned the stress involved in getting cancer but stated that the most difficult aspect was the perceived incorrect or deficient treatment, which they viewed as a sign that their lives and health were not sufficiently valued.

The other nine events represent experiences related to orthopedic conditions, such as hip or knee interventions; surgery on the cheek/neck; incorrect anesthesia; incorrect medication; radiation injury; and deficient stroke treatment.

The events include errors/failures that were discovered while the patient was in hospital as well as errors/serious complications that became evident after discharge. Several of the informants believed that medical assessments, test analyses or organizational/administrative systems did not function properly. According to the interviewee’s, the events resulted in functional impairment requiring further surgery or treatment, difficult rehabilitation, organs that failed, pain and a more complicated sequence of treatment.

Ignored concerns or signs of complications

All the informants understood that hospital treatment involves a certain degree of risk. They stated that information about operations, other treatments and delayed diagnosis was presented in a standardized and everyday manner. When an undesirable event occurred, the health personnel did not appear to relate to the event or come to grips with the problem that the patient experienced Health personnel were perceived as trivializing, rejecting, skeptical or doubtful.

Most of the respondents described a powerful inner concern that something was wrong but felt as though they were ignored or overlooked when they mentioned their concern. In the case of diagnostic errors, the concern was related to bodily symptoms or a long wait for or absence of further tests and treatment. A woman with a delayed diagnosis of breast cancer explained:

Eva: “ I didn’t like that lump, and I felt strongly that something wasn’t right ... The lump was visible and painful. I went to the doctor several times and tried to speak up ..., but mammography and tissue samples had been taken, and the specialist at the hospital had signed them as normal.”

It was later proven that an error had been committed with the samples and that the cancer had been discovered many months earlier. The test results had rested in a pile at the hospital for new assessment, but a review was not performed. Positive test results were found coincidentally.

The events that became evident during the hospital stay or after returning home concerned symptoms of errors or of complications assessed as normal issues or symptoms that would disappear over time.

Peter: “I asked how the operation had gone, and the doctor said that it had been a little more complicated than first envisioned, but everything had gone well. I had pains when discharged, but I could still manage to move my arm. At home, I suddenly could not hold my arm out. I contacted the doctor at the hospital; he said it was completely normal and I could relax. It would get better again. But it certainly did not: it got worse and worse. I spoke to the hospital again but got the same answer ...”

After a long struggle, neurological examinations found nerve damage that resulted in permanent pain, paralysis and loss of function.

When errors became visible, health personnel appeared unwilling to talk about the errors, support the patients during a difficult situation, or help with further follow-up and treatment.

Lack of responsibility and error correction

The informants reported their experiences of being in the middle of situations that were decisive for life and health. They had expectations that any damages and errors would be rapidly limited and corrected, but they were disappointed. Few of the informants received an apology or detailed explanation of the event that had occurred, and none of them had a meeting with those involved to clarify the situation afterwards. The two informants who received an apology and explanation viewed them as noncommittal because they were not invited to share their experiences with the staff in general. Most informants perceived that hospital staff denied responsibility by avoiding dialogue and not providing suggestions for correction and damage limitation. The informants clearly expressed their disappointment.

Kari: “The doctor held his head up and walked straight past me; I know he saw me - that was a really unpleasant feeling.” Tone: “I had gotten much worse, but the doctor just turned around and walked out. And that was that. It was this denial of responsibility; that you were not allowed to talk about it like ... it would have meant a lot to me to have a good discussion with someone...”

The accounts show that it was essentially the patients’ responsibility to prove the AE. They encountered a hospital culture that normalized and trivialized AEs by referring to the fact that current procedures and rules had been followed and/or that tests and examinations showed normal findings.

Bjørn: “Not very much I can do when the doctor says it looks fine. You have to be quite active and more or less healthy to be able to keep up with all this. I don’t know ... you feel almost like a scoundrel. Feel that you are being met with doubt the whole time.”

This was experienced as a challenge in that patients can refer to only unexpected symptoms and feelings. Patients experiencing pain, discomfort and vulnerability must struggle to ensure that their condition is re-assessed. In Camilla’s case, after a hip operation, the prosthesis came out of joint. She heard a click , which was followed by serious pains and mobility problems. The staff thought that the pains were normal postoperative pains, and the patient had to make a fuss to get a new X-ray, which confirmed the luxation. She then had to wait four painful days for reoperation, which revealed a splinter of bone that had remained in the hip joint. Other informants experienced similar difficulties with circumstantiation and clinicians who they perceived as rejecting and arrogant:

Nina: “I could see for myself that the muscle was just hanging, but they said it would get better.” “He (the doctor) said that everything was perfect without touching me. I couldn’t understand how ... he had just done perfect work.”

These deficiencies reinforced the informants’ feelings of discouragement, vulnerability, pain and bitterness. The interviewees perceived that those who were responsible did not wish to accept the consequences of their decisions and actions, while the patients had to struggle to receive further help and treatment. The informants felt that they were not prioritized and that the time between the discovery of the error and the start of treatment could be long.

Peter: “Everyone can be unlucky, but can’t they just be nice enough to say so. Say ‘we’ll help you’ -why can’t they do that?”

Responsibilities regarding follow-up appeared to be unclear, and the informants stated that they were placed on new waiting lists where they received little or no information about what was to be done and when.

Eva: “That was when the struggle began, and that was the worst. I was naive enough to think that once an error had been discovered then things would move quickly. Nothing could be done about what had happened, but they could come to grips with things quickly, but that didn’t happen ... I had to fight my way to treatment, pure and simple. I had to stay on the phone and ring, and ring, and ring ...”

Lack of support, loyalty and learning

All the informants felt alone with their problems. Admitted patients found that hospital personnel rarely noticed their need for physical or mental support.

Kari: “There has been no real follow-up with me as a person, and I don’t feel that I have had any support ...”

Nurses and other carers showed understanding related to the performance of concrete tasks such as pain relief, showering or toilet visits but were otherwise perceived to be silent and absent. However, there were references to nurses who expressed understanding and recommended that the patient seek help from the patient and services ombudsman or report the incident as a patient injury. Informants described physiotherapists as one professional group that was supportive and asked questions about the patients’ progress and if they could help in any way.

The informants described how errors and defects in case notes made the course of further treatment difficult. Hospital doctors, other health personnel and GPs did not have knowledge about earlier events or complications due to a lack of written documentation in patient records. Some of these professionals notice problems and support the patient, while others are more concerned about documentation in the medical records before they refer patients to new examinations, check-ups and rehabilitation. The released discharge reports confirm the lack of descriptions of events and complications. When new health professionals must refer to incomplete written records, it is difficult for the patient to gain acceptance of his or her version and participate in decision making that could correct the error or prevent a new error from occurring. Thus, reoperations or corrective treatments are viewed as new treatments without considering the situation as a whole. Informants perceived this view as problematic and expressed that clinicians and administrative systems should be aware of the event, facilitate better follow-up, and be more attentive to patient needs in the situation.

Several of the informants spoke of specialist assessments and second opinions that finally supported their assertion that an error had occurred. The feeling of being seen and cared for as a person was of great significance. Kari explained this when describing the surgeon who performed the reoperation.

Kari: “He has followed up, telephoned me and given me very good information. This is reassuring, and it is directed at me as a person, not just two knees.”

However, informants also found that verbal feedback did not necessarily correspond with written statements in the medical records.

Bjørn: “He actually saw what was wrong with me straight away. It was good to have it confirmed ... but he did not want to stab a colleague in his back, which is why the report is as it was. However, he would follow my case, and he was one hundred per cent behind me. Therefore, I imagine he has something of a bad conscience. This hierarchy is like nothing else in society. They can’t just sit and cover each other.” Mari: “The doctor I spoke to said that the first doctor had made an incorrect assessment but that the system then got involved. A cover-up begins, and there are rules about what they can say and what they can do. Anyway, I am glad he was honest enough to say that. It helps a little.”

The informants appeared to be strongly affected by the events and their impact on their lives. At the same time, they believed that health personnel and the health service at both the individual and system levels should learn from the events and prevent similar events in the future. They interpreted the experience of a lack of recognition, disclosure and understanding to imply that learning is hindered when events are trivialized to such an extent.

The struggle against perceived negligence

The purpose of this study was to illuminate patients’ experiences of AEs as bottom-up inputs in patient safety work. Our sample represents a variety of diagnoses and conditions. The fact that all the “before treatment” cases in our study involved cancer, in contrast to only one of the during/after treatment cases, was somewhat surprising. This may be due to the sample composition. However, we are unable to evaluate this issue further at this time. One major finding concerns patients’ struggle against perceived negligence by clinicians and hospitals when they present their anxiety and concerns or point out errors and deficiencies. In summary, these reports describe the clinicians’ and health service’s avoidance or lack of response, signs of denial of responsibility and use of loyalty systems to largely support and protect each other. In these cases, patients are shocked by illness [ 1 ], and this shock may double due to injury or even triple due to the lack of adequate follow-up and treatment. The descriptions reveal potential barriers to openness and indicate that these patients were not invited into processes of open disclosure. This finding is in line with results reported by Iedema et al. [ 12 ], Ocloo [ 14 ] and Mazor et al. [ 13 ], who found that patients clearly expressed that a patient-centered and respectful dialogue to promote healing, learning and safety should follow the disclosure of an AE. In our study, informants’ descriptions also revealed a practice that was not in line with Norwegian governmental policy statements regarding the promotion of trust and openness in patient safety work [ 7 ].

However, some informants reported positive experiences of health personnel who acknowledged their experiences, offered help related to their condition and supported them in reporting the incident.

On the other hand, health personnel have been described as the second victims and also experience great stress from AEs; these factors must be taken into consideration [ 42 ]. Furthermore, individual clinicians may lack communication skills and may generally find it easier to avoid difficult conversations [ 18 ]. Several informants referred to their perceptions of doctors’ reluctance to criticize colleagues openly. This reluctance could connect to the Medical Associations’ ethical rules [ 43 ] of the handling of such events between colleagues but could also indicate that professional codes of collegiality and loyalty exist within the medical profession and potentially hamper an open disclosure process [ 17 , 18 ].

At a more general level, the breaches may represent more or less latent and unrecognized driving forces against defining errors and serious complications in hospitals. Hospitals work hard to avoid negative figures in reports and/or to maintain their reputation and income; paradoxically, such efforts may tend to counteract openness about undesirable circumstances [ 17 ]. However, we have no data to evaluate the extent to which hospitals used the errors narrated by study participants in learning processes to improve patient safety. Nevertheless, our findings may be interpreted as signs of professional and organizational cultures that do little to communicate errors to patients and to include them in learning processes at any organizational level, which potentially impedes open disclosure and even hampers learning from AEs as outlined in high-quality guidelines, e.g. guidelines from Harvard hospitals [ 9 ]. This could contribute to the understanding of why patients struggle to obtain evidence that recognizes the event and promotes further support.

The discursive power

The participants’ perception of being ignored and that the definition of events was not in line with the personal consequences that they experienced, was problematic. Our findings indicate that practitioners and hospitals have discursive power in the form of expert knowledge , which determines and limits the prevailing definition of the truth in the situation [ 27 ]. In general, professional knowledge and the hospital environment give health personnel an authority to assess the best course of action in any patient situation. Participants reported lack of acknowledgement of their condition in the encounter with the experts. This finding corroborate results from Eriksson and Svedlund who studied patients’ dissatisfaction with hospital care [ 44 ]. The results further shows that patients did not experience to be part of assessment processes or in the social construction of categories that defined what was considered normal in the patient’s situation. Sharpe and Faden argue that the definition of medical injury is overly one-sided and tends to reflect a narrow clinical understanding that excludes non-clinical perspectives and outcomes that the patients experience as damaging [ 45 ]. In this sense, the understanding of AEs may be selective and contribute to disciplinary actions and stigmatization [ 30 ]. Events described as foreseeable complications, misunderstandings, organizational failure etc. place the responsibility outside the potential control of the health personnel and attribute the events to chance, natural surgical risk or patient factors.

Some informants reported feeling uneasy when asking questions. Patients who speak up and ask questions may thus be perceived as extra concerned, having a negative attitude, being bothersome, difficult to treat etc. When problem descriptions take little account of patient perspectives, there is a risk that general intentions about increased patient involvement, empowerment, openness and AE reduction are not spread downwards through the organization and do not make contact with the prevailing values of the professional and organizational cultures. In practice, this may imply that a number of patients do not receive the treatment and follow-up that they need and begin a difficult process to ensure that their condition is acknowledged. The patients in our study were not involved in designing measures to avoid incidents, and to their knowledge, their experiences were not pursued for subsequent learning. Thus, intentions regarding patient-centered care and patient participation in the development of safety efforts appeared to be practiced to a limited extent in the reported cases.

Patient safety within fixed frames

Patterns of action that replicate many times in organizations like hospitals, become typified and institutionalized as permanent attitudes, actions and methods that tend to be taken as a given [ 31 , 32 ]. Within these frames, social practice unfolds. In this way, awareness in the everyday understanding of patient treatment has become routine. This issue not only applies to individual errors or deficiencies related to everyday performance, but may also represent practice cultures in which the exclusion of patients and events becomes routine and maintained by the prevailing knowledge regimes and professional hierarchies. Changing these regimes requires increased awareness, not only in terms of the authorities’ intentions to increase patient safety but also in terms of the inclusion of both personnel and patients at all levels of professional and organizational cultures [ 31 ].

Learning processes can be inhibited if the goal, in this case, the reduction of AEs and improved follow-up with patients, does not coincide with other goals, such as maintaining professional autonomy, promoting the individual clinician’s career opportunities or earning the status of the professional center or hospital with the fewest reported errors. Argyris and Schӧn [ 46 ] refer to this dilemma as the differences between espoused theory and theory-in-use , where ideals and reality do not concur. Changing fixed attitudes and patterns requires obtaining information that includes all relevant perspectives, weighing alternative knowledge-based actions, continuously assessing the consequences of the action taken and questioning whether the action is congruent with governing values [ 46 ].

The study results show that patient experiences may serve to identify barriers to patient safety work that are necessary to overcome to prevent future AEs.

Strengths and limitations

The data are from interviews with a small, selected group of patients who had the energy and resources to contact the Health and Social Services ombudsman for assistance. Thus, the findings cannot be generalized to the entire population of patients who experience AEs in Norwegian hospitals. Personal stories might also be selective, exposed to recall bias and affected by a wish to narrate only aspects that favor the quest for some kind of compensation following an AE. In addition, the relatively long time span between the incidents and the interview may have provided informants with new contexts of interpretation due to their personal biography and the increased public attention toward patient safety issues. On the other hand, an expanded time frame may contribute to greater richness in terms of reflections on the event. Overall, the patient stories bear significant similarities and appear to be consistent across all subject areas and diagnoses, across a wide range of institutional settings, and regardless of whether the persons had applied for or received compensation. This consistency should contribute to the trustworthiness of results and indicates that the stories reveal important aspects of a widespread deep structure within hospitals that inhibits the realization of principles of open disclosure. Another important limitation is that the study does not include clinicians or health service providers’ perspectives of the events. Some of the events may expose grey areas between complications and AEs. Nevertheless, experiences of a struggle against perceived negligence are present across all stories.

Implications

Patients are in need of emphatic and professional acceptance of responsibility when an error occurs. Health personnel must listen to the patient and bear in mind that communication and open dialogue have great implications for the person’s evaluation of the event and future life and health. This qualitative study may promote reflection among care providers irrespective of professional area, hospital management and government. Acknowledging that patients are co-producers with important knowledge about their health situation is essential to the development of safer treatment. Future research should include a larger number of patients as well as organizational and professional perspectives. The impact of AEs on the daily lives of patients and their families should also be studied.

This small-scale, qualitative study shows that some patients experience a lack of care, openness and acceptance of responsibility when AEs occur. They perceived that their perspective was largely ignored. We have no data to evaluate whether their cases are used as input for learning and development in patient safety work. However, open disclosure guidelines advocate for the inclusion of patients at early stages and throughout the process. Our results indicate that the full potential of such learning and development is not realized in hospital units. Considerable cultural and attitudinal changes in day-to-day patient care are necessary. Patients exposed to AEs should be invited into open disclosure processes and included as fellow architects of their own health and safety.

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Acknowledgements

We are grateful to all the participants who shared their accounts with us. We also thank the Health and Social Services ombudsmen for their recruitment efforts.

This study was funded by UiT, The Arctic University of Norway.

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The dataset supporting the conclusions of this article is not made available to secure participant confidentiality and because of the consistency of a large amount of qualitative interview transcripts in Norwegian.

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Gunn Hågensen, Gudrun Nilsen & Grete Mehus

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GH was responsible for the conception and design of the study, the acquisition of data, the analysis and interpretation of data and the drafting of the manuscript. GN was involved with the design of the study, the analysis and interpretation of data, and the revision of the article. GM contributed to the refinement of the data analysis and the preparation of the manuscript. GM provided critical comments and suggestions for revisions. NH contributed to the conception and design of the study, the analysis of data, the incorporation of sociological theory, and the writing and critical revision of the manuscript. All authors read and approved the final version of the manuscript.

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The Norwegian Social Science Data Services (NSD) gave their approval (Reference number 34221), while the Regional Committee for Medical Research Ethics judged that the project did not require approval (REK North Reference number 2013/131), corresponding to the Norwegian regulations for ethical research practice and ethical principles stated in the Helsinki declaration. After receiving oral and written information about the design and goals of the study, all participants gave their voluntary approval for participation by signing an informed consent form.

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Hågensen, G., Nilsen, G., Mehus, G. et al. The struggle against perceived negligence. A qualitative study of patients’ experiences of adverse events in Norwegian hospitals. BMC Health Serv Res 18 , 302 (2018). https://doi.org/10.1186/s12913-018-3101-2

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DOI : https://doi.org/10.1186/s12913-018-3101-2

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