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NHMRC Information Paper : Evidence on the effectiveness of homeopathy for treating health conditions

9781925129298 (ISBN)

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National Health and Medical Research Council (Australia), author, issuing body. (2015). NHMRC Information Paper : Evidence on the effectiveness of homeopathy for treating health conditions Retrieved August 28, 2024, from http://nla.gov.au/nla.obj-788185887

National Health and Medical Research Council (Australia), author, issuing body. NHMRC Information Paper : Evidence on the effectiveness of homeopathy for treating health conditions Canberra ACT 2601, ACT: National Health and Medical Research Council, 2015. Web. 28 August 2024 < http://nla.gov.au/nla.obj-788185887 >

National Health and Medical Research Council (Australia), author, issuing body. 2015, NHMRC Information Paper : Evidence on the effectiveness of homeopathy for treating health conditions National Health and Medical Research Council, Canberra ACT 2601, ACT viewed 28 August 2024 http://nla.gov.au/nla.obj-788185887

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How to use the evidence: assessment and application of scientific evidence

  • P. Glasziou , L. Irwig , +1 author G. Colditz
  • Published 1999

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The Australian report

In March 2015, the Australian National Health and Medical Research Council (NHMRC) published an Information Paper on homeopathy, commonly referred to as ‘The Australian Report’. 1

This document concluded that “… there are no health conditions for which there is reliable evidence that homeopathy is effective” . 2

The report triggered headlines around the world suggesting NHMRC had found that homeopathy does not work for any condition. 3

However, on 26 August 2019 NHMRC CEO Prof Anne Kelso provided the following clarification on the findings of the 2015 Homeopathy Review:

“Contrary to some claims, the review did not conclude that homeopathy was ineffective.”

An extensive investigation by the Australian Homeopathic Association (AHA) into NHMRC’s conduct, combined with an in-depth scientific analysis of the review by HRI, revealed evidence of serious procedural and scientific misconduct, including the fact that the published report was NHMRC’s second attempt – a first report written in 2012 was never disclosed to the public.

Rachel Roberts, HRI Chief Executive  says: “The public has a right to know that there are high quality studies showing homeopathy works for some medical conditions, such as hay fever, sinusitis and diarrhoea in children – information that was lost only due to NHMRC’s mishandling of the evidence. If the evidence on conventional medicine was treated this way there would be an outcry – and rightly so. NHMRC’s job was to accurately summarise the body of evidence for homeopathy for the public, a task in which they categorically failed.”

Missing first report finally released

After an ongoing campaign by stakeholders and the general public, in August 2019 NHMRC finally released the draft 2012 report in which the author concluded that there is “encouraging evidence for the effectiveness of homeopathy” in five medical conditions.

Why is this First Report important? Less

The First Report   was funded by the Australian taxpayer, yet its existence was never disclosed by NHMRC, let alone its ‘encouraging’ positive findings for five medical conditions.

Patients suffering from these conditions deserve to know that research suggests homeopathy may help them. This draft report found encouraging evidence for the effectiveness of homeopathy for fibromyalgia, otitis media (ear infections), upper respiratory infections in adults and post-operative ileus (first time to flatus after surgery), and for side-effects of cancer treatment (prevention of acute dermatitis during radiotherapy and chemotherapy-induced stomatitis).

Researchers also need to know which avenues are most promising in terms of identifying new clinically effective treatments; reports such as this are extremely important for identifying which medical conditions and treatments have been found to be effective in some studies and are therefore worthy of further investigation.

Research requires significant funding and resources. NHMRC’s false claim in the 2015 Homeopathy Review that no good trials have found homeopathy to be effective has unfairly damaged the reputation of homeopathy, making it far harder for new research studies in this field to be carried out due to the misperception created that it is a ‘therapeutic dead end’.

The ‘encouraging’ evidence that exists for some medical conditions, some of which was already evident in 2012, is simply not consistent with the premise that homeopathy is ‘impossible’ – it indicates that homeopathy warrants further research.

Full First Report Q+As .

Australian Report key facts

  • NHMRC did the homeopathy review twice,  producing two reports, one in July 2012 and the one released to the public in March 2015.
  • The existence of the first report was not disclosed to the public – it was only discovered through Freedom of Information (FOI) requests.
  • NHMRC say they rejected the first report because it was poor quality despite it being undertaken by a reputable scientist  and author of NHMRC’s own guidelines on how to conduct evidence reviews.
  • FOI requests have revealed that a member of NHMRC’s expert committee overseeing the review process – Professor Fred Mendelsohn –  confirmed the first review to be high quality  saying –   “I am impressed by the rigor, thoroughness and systematic approach given to this evaluation [….] Overall, a lot of excellent work has gone into this review and the results are presented in a systematic, unbiased and convincing manner.” 
  • NHMRC said the results of the second  report published in 2015 were based on a “rigorous assessment of over 1800 studies”. In fact results were based on only 176 studies .
  • NHMRC used a method that has never been used in any other review , before or since .  NHMRC decided that for trials to be ‘reliable’ they had to have at least 150 participants and reach an unusually high threshold for quality . This is despite the fact that NHMRC itself routinely conducts studies with less than 150 participants .
  • These unprecedented and arbitrary rules meant the results of 171 of the trials were completely disregarded as being ‘unreliable’ leaving only 5 trials NHMRC considered to be ‘reliable’ . As they assessed all 5 of these trials as negative, this explains how NHMRC could conclude that there was no ‘reliable’ evidence.
  • Professor Peter Brooks, Chair of the NHMRC committee that conducted the 2015 review, signed conflict of interest form declaring he was not “affiliated or associated with any organisation whose interests are either aligned with or opposed to homeopathy”, despite being a member of anti-homeopathy lobby group ‘Friends of Science in Medicine’
  • NHMRC’s guidelines state that such committees must include experts on the topic being reviewed, yet there was  not one homeopathy expert  on this committee.

Complaint submitted to Commonwealth Ombudsman

In August 2016, the Australian Homeopathic Association (AHA) made a formal complaint to the Commonwealth Ombudsman against the National Health and Medical Research Council (NHMRC). The complaint, investigated under the PID (aka ‘Whistle-blower) Act”, aimed to hold NHMRC accountable for bias, misconduct and ultimately misleading the public in their inaccurate 2015 report on homeopathy.

The Homeopathy Research Institute (HRI) provided expert input to the investigation detailing the flawed scientific methods used by NHMRC to produce their homeopathy review.

The Ombudsman’s Office publicly announced on 4 August 2023 that the seven-year investigation had been closed, stating that: “ Despite our best efforts, it was not possible to engage an expert (or experts) to provide independent advice to our Office on this subject. In the absence of independent, expert scientific expertise we have not been able to conclusively determine those matters of scientific methodology.”

Rachel Roberts, Chief Executive of HRI, said:

“The use of unprecedented and flawed scientific methods by NHMRC is at the very heart of this case. It is therefore extremely disappointing that the Ombudsman could not find any scientific experts, sufficiently free from bias – either for or against homeopathy – who were willing to take on the role of judging the validity of the methods used by NHMRC.

Since the NHMRC report on homeopathy has been widely quoted, it is profoundly regrettable that, despite a seven-year investigation, the scientific misconduct case against NHMRC remains unanswered.”

Download the  Executive Summary of the Ombudsman submission   here . Download the Office of the Commonwealth  Ombudsman’s final statement   here . Download the HRI Statement on Closure of the Ombudsman Complaint here .

Roberts says, “NHMRC’s review is a shocking example of misreporting. Decision-makers and the scientific community rely on these kinds of reports and need to trust their accuracy. This is not about anyone’s personal opinion as to whether homeopathy works or not. It is about the importance of evidence being reported objectively, whatever it says, and NHMRC did not do that.”

The complainants are now waiting to hear back from the Ombudsman regarding their submission. As NHMRC’s inaccurate Homeopathy Review has had a significant impact on the field of homeopathy research worldwide, HRI will share any news regarding the complaint as the case progresses.

The missing first report

NHMRC’s investigation into Homeopathy ran from 2010 to 2015. NHMRC initially worked with an external contractor at the University of South Australia (UniSA) – from April 2012-August 2012 – to produce a review of the evidence on Homeopathy to inform the Australian public.

The report produced was called The Effectiveness of Homeopathy: An overview review of secondary evidence .

This review, paid for by Australian tax payers, was never made public and NHMRC refused to release it for over three years, despite repeated Freedom of Information requests.

After terminating the contract with the first review team, a second external contractor – OptumInsight – was hired to do the Homeopathy review again from December 2012-March 2015.

HRI is not alone in criticising the accuracy of NHMRC’s findings

FOI requests have brought to light that two independent experts also raised concerns over the conclusions of the 2015 report  during peer review, prior to final publication. The Australasian Cochrane Centre commented that for some conditions, “…. ‘no reliable evidence’ does not seem an accurate reflection of the body of evidence”; a second expert felt “uncertain of the definitive nature of the Report’s conclusions”. NHMRC chose not to act on this feedback and did not amend their conclusions.

The real story behind the headlines

The Information Paper is designed for the general public and aims to provide a summary of the findings of a review of systematic reviews, carried out by NHMRC to assess the evidence base for effectiveness of homeopathy in humans. 2

Confusing ‘lack of evidence of effect’ with ‘evidence of a lack of effect’

The Report’s conclusion that there is ‘no reliable evidence’ that homeopathy works, has been widely misunderstood, with people believing it meant that the NHMRC found that homeopathy does not work for the conditions tested, which would be a completely different result.

This misunderstanding triggered widespread media coverage, propagating the inaccurate story that the NHMRC found homeopathy to be no better than placebo for all the conditions.

In fact, NHMRC concluded that homeopathy worked no better than placebo for only 13 of the 61 health conditions they investigated .

HRI’s in-depth scientific analysis of the Australian Report revealed multiple examples of bias and misreporting which explain how NHMRC arrived at such a definitive and negative position, at odds with the conclusions of the majority of other more academically rigorous  systematic reviews and meta-analyses  on homeopathy.

Most crucially, NHMRC’s findings hinge primarily on their definition of reliable evidence : for a trial to be deemed ‘reliable’ it had to have at least 150 participants and a quality score of 5/5 on the Jadad scale (or equivalent on other scales). Trials that failed to meet either of these criteria were dismissed as being of ‘ insufficient quality and/or size to warrant further consideration of their findings ’.

Setting such a high quality threshold is very unusual, but the N=150 minimum sample size criterion is arbitrary, without scientific justification, and unprecedented in evidence reviews .

Out of 176 individual studies the NHMRC included in the homeopathy review, only 5 trials met their definition of ‘reliable ‘, none of which, according to their analysis, demonstrated effectiveness of homeopathy. This explains why NHMRC concluded there is ‘no reliable evidence’ that homeopathy is effective.

Contrary to NHMRC’s findings, there are  ‘good quality, well-designed studies with enough participants for a meaningful result ‘ (to use NHMRC’s description of a reliable study) which show that certain homeopathic treatments are effective for certain conditions such as hay fever, sinusitis, upper respiratory tract infections, diarrhoea in children and lower back pain. The fact that the results of such studies were unjustifiably dismissed means that NHMRC have misled the public by misreporting the evidence for effectiveness of homeopathy.

Find out more on our Australian Report FAQs page

Document archive

Nhmrc publications 2014.

Draft Australian Report Overview Report Overview Report Appendices Review of Submitted Literature List of Submitted Evidence

HRI publications 2014-23

HRI Statement 2023 HRI analysis HRI response HRI submission to public consultation

References Less

1. NHMRC Information Paper: Evidence on the effectiveness of homeopathy for treating health conditions [March 2015] | Full text

2. Effectiveness of Homeopathy for Clinical Conditions: Evaluation of the Evidence. Overview Report. Prepared for the NHMRC Homeopathy Working Committee by Optum. October 2013 | Full text

3. Homeopathy is bunk, study says. The Guardian, 8 April 2014 | Article

Back to The homeopathy debate

Australian Report FAQs

HRI responses

  • HRI Statement 2023
  • HRI Analysis
  • HRI Statement 2019
  • First Report Q+A
  • Press Release 2017
  • Ombudsman 2016 Executive Summary

Translations

  • Pressemitteilung
  • Zusammenfassung
  • エグゼクティブサマリー

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National Health and Medical Research Council (NHMRC)

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NHMRC, GPO Box 1421, Canberra, Australian Capital Territory, ACT,2601, Australia Tel: (61) 2 6217 9000 Fax: (61) 2 6217 9100 Email: [email protected] Website: www.nhmrc.gov.au Contact: Executive Director

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The National Health and Medical Research Council (NHMRC) (Australia) consolidates within a single national organization the often independent functions of research funding and development of advice. One of its strengths is that it brings together and draws upon the resources of all components of the health system, including governments, medical practitioners, nurses and allied health professionals, researchers, teaching and research institutions, public and private programme managers, service administrators, community health organizations, social health researchers and consumers.

Biomedical (C J Martin) Fellowships

Subjects: Biomedical sciences.

Purpose: To enable fellows to develop their research skills and work overseas on specific research projects within the biomedical sciences under nominated advisers.

Eligibility: Open to Australian citizens or graduates from overseas with permanent Australian resident status who are not under bond to any foreign government. Candidates should hold a Doctorate in a medical, dental or related field of research, be actively engaged in such research in Australia and have no more than 2 years postdoctoral experience at the time of application.

Level of Study: Postdoctorate

Type: Fellowship

Value: An allowance of Australian $5,000 per year is payable for research support, including conference travel, for the 2 year Australian portion of the Fellowship. Please check website for full detail

Length of Study: 4 years, the first 2 of which are to be spent overseas and the final 2 in Australia

Frequency: Annual

Study Establishment: Institutions approved by the NHMRC, such as teaching hospitals, universities and research institutes

Country of Study: Any country

No. of awards offered: Varies

Application Procedure: Application forms available from the website.

Closing Date: July 7th

Funding: Government

No. of awards given last year: 31

No. of applicants last year: 79

Additional Information: Please check website for more details.

Biomedical (Dora Lush) and Public Health Postgraduate Scholarships

Subjects: Biomedical sciences and public health.

Purpose: To encourage science Honours or equivalent graduates of outstanding ability to gain full-time health and medical research experience.

Eligibility: Open to Australian citizens who have already completed a science Honours degree (or equivalent) at the time of submission of the application, science Honours graduates and unregistered medical or dental graduates from overseas, who have permanent resident status and are currently residing in Australia. The scholarship shall be held within Australia.

Level of Study: Postgraduate

Type: Scholarship

Value: Varies

Length of Study: 1 year, renewable for up to 2 further years

Country of Study: Australia

Application Procedure: Applicants should visit the website at https://www.nhmrc.gov.au/grants-funding/apply-funding/postgraduate-scholarships/postgraduate-scholarships-categories-award for details.

Closing Date: Varies

No. of awards given last year: 51

No. of applicants last year: 133

For further information contact:

Centre for Research Management & Policy, NHMRC, GPO Box 9848, Canberra, Australian Capital Territory

Biomedical Australian (Peter Doherty) Fellowship

Purpose: To provide full-time training in basic biomedical sciences research in Australia.

Eligibility: Open to Australian citizens or graduates from overseas with permanent Australian resident status who are not under bond to any foreign government. Candidates should hold a Doctorate in a medical, dental or related field of research or have submitted a thesis for such by December in the year of application, be actively engaged in such research in Australia or overseas and have no more than 2 years postdoctoral experience at the time of application.

Value: Fellowship salary packages at the Training Support Package level 1 is $62,250. An allowance of $5,000 per year is payable for research support, including conference travel

Length of Study: 4 years

No. of awards given last year: 30

No. of applicants last year: 100

Career Development Fellowship

Subjects: Any human health-related research area.

Purpose: To help researchers to conduct research that is internationally competitive and to develop a capacity for independent research.

Eligibility: Open to Australian citizens or permanent residents, normally between 3 and 9 years postdoctoral experience.

Value: Australian $96,040–106,230 per year

Length of Study: 5 years

Study Establishment: Institutions approved by NHMRC, such as teaching hospitals, universities and research institutes

Application Procedure: Application forms available from the website www.nhmrc.gov.au .

Closing Date: March 19th

No. of awards given last year: 54

No. of applicants last year: 434

Clinical (Neil Hamilton Fairley) Fellowship

Subjects: All health-related fields.

Purpose: To provide training in scientific research methods.

Eligibility: Open to Australian citizens or graduates from overseas with permanent Australian resident status who are not under bond to any foreign government. Candidates should hold a Doctorate in a health-related field of research or have submitted a thesis for such by December of the year of application, be actively engaged in such research in Australia and have no more than 2 years postdoctoral experience at the time of application.

Value: Fellowship salary packages at the Training Support Package level 1 is currently at $62,250 and if appropriate, clinical loadings will be paid

Application Procedure: Application form available from the website.

No. of awards given last year: 4

No. of applicants last year: 10

Additional Information: For more information check website.

NHMRC Early Career Fellowship

Subjects: Scientific research, including the social and behavioural sciences, that can be applied to any area of clinical or community medicine.

Purpose: To undertake research that is both of major importance in its field and of benefit to Australian health.

Eligibility: Open to Australian citizens or graduates from overseas with permanent Australian resident status, who are not under bond to any foreign government. Candidates should hold a Doctorate in a health-related field of research or have submitted a thesis for such by December of the year of application, be actively engaged in such research in Australia or overseas and have no more than 2 years postdoctoral experience at the time of application.

Value: Funding is for 4 years at TSP1 Level, which currently is $67,508

Application Procedure: Application forms are available from the website.

Closing Date: May 1st

No. of awards given last year: 9

No. of applicants last year: 21

Additional Information: For more information check website www.nhmrc.gov.au/grants-funding/apply-funding/early-career-fellowships .

NHMRC Medical and Dental and Public Health Postgraduate Research Scholarships

Subjects: Medical, dental and public health research.

Purpose: To encourage medical and dental and public health graduates to gain full-time research experience.

Eligibility: Open to Australian citizens who are medical or dental and public health research graduates registered to practice in Australia, with the proviso that medical graduates can also apply during their intern year and that dental postgraduate research scholarships may be awarded prior to graduation provided that the evidence of high quality work is shown. Also open to medical and dental graduates from overseas who hold a qualification that is registered for practice in Australia, who have permanent resident status and are currently residing in Australia.

Study Establishment: Institutions approved by the NHMRC such as teaching hospitals, universities and research institutes

Application Procedure: Available from the website at www.nhmrc.gov.au/grants-funding/apply-funding/postgraduate-scholarships/postgraduate-scholarships-categories-award .

No. of awards given last year: 6

No. of applicants last year: 12

Additional Information: The award is divided into two categories: Medical and Dental Public Health Postgraduate Research Scholarships and Public HealthPostgraduate Research Scholarships.

NHMRC/INSERM Exchange Fellowships

Purpose: To enable Australian Fellows to work overseas on specific research projects in INSERM laboratories in France and vice versa.

Eligibility: Open to Australian citizens and permanent residents, who are not under bond to any foreign government, who hold a Doctorate in a medical, dental or related field of research or have submitted a thesis for such by December in the year of application, are actively engaged in such research in Australia and have no more than 2 years postdoctoral experience at the time of application.

Value: Fellowship stipend Australian $62,250. A maintenance allowance for research support of $5,000 per year For more information please check website www.nhmrc.gov.au/_files_nhmrc/file/grants/apply/training/insermfy.pdf

Length of Study: 4 years, the first 2 of which are to be spent in France and the final 2 in Australia

Study Establishment: Institutions approved by the NHMRC, such as teaching hospitals, universities and research institutes, and INSERM laboratories in France

Country of Study: France or Australia

No. of awards offered: 1

Application Procedure: Applications forms available from the website.

No. of awards given last year: 1

Additional Information: This fellowship is awarded in association with I’Institut National de la Santé et de la Recherche Médicale (INSERM), France.

Public Health Australian Fellowship

Subjects: Public health.

Purpose: To provide full-time training in public health research in Australia.

Eligibility: Applicants should hold a Doctorate in a health-related field of research or have submitted a PhD by December in the year of application and have no more than 2 years postdoctoral experience. Applicant must also, for years 1 and 2, nominate a department [preferably institution] and research group other than that where the applicant’s doctoral qualifications were obtained. Open to Australian citizens or permanent residents.

Value: Australian $67,508 and $5,000

No. of awards given last year: 17

No. of applicants last year: 61

Public Health Overseas (Sidney Sax) Fellowships

Purpose: To provide full-time training overseas and in Australia in public health research.

Eligibility: Applicants should hold a Doctorate in a health-related field of research or have submitted a PhD by December in the year of application and have no more than 2 years postdoctoral experience. Open to Australian citizens or permanent residents.

Value: Fellowship salary support packages at the Training Support Package level 1, that is $62,250, will be paid. Minimum cost airfares for the Fellow and dependants will be provided for direct travel to, and return from, the overseas centre. Additional overseas and Australian allowances are also payable

No. of awards given last year: 3

No. of applicants last year: 11

Training Scholarship for Indigenous Health Research

Subjects: Indigenous Australian Health Research.

Purpose: To provide support for research training or training leading to research areas of particular relevance to Indigenous Australians.

Eligibility: Applicant must be an Australian citizen or Australian permanent resident, have made prior arrangements with the Head of Department or Institution in which they propose to study, provide a specific study plan within a clearly defined area and conduct research of potential benefit to Australia.

Value: Depends on the qualification and current registration. Please check website

Length of Study: 1 year, renewable up to further 2 years

Application Procedure: Available from the website at www.nhmrc.gov.au/grants-funding/directory-previous-nhmrc-grants/training-scholarships-indigenous-health-research .

Closing Date: August 4th

No. of applicants last year: 6

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Shekelle PG, Maglione MA, Luoto J, et al. Global Health Evidence Evaluation Framework [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Jan.

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Global Health Evidence Evaluation Framework [Internet].

Table b.9 nhmrc evidence hierarchy: designations of ‘levels of evidence’ according to type of research question (including explanatory notes).

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LevelIntervention Diagnostic Accuracy PrognosisAetiology Screening Intervention
I A systematic review of level II studiesA systematic review of level II studiesA systematic review of level II studiesA systematic review of level II studiesA systematic review of level II studies
IIA randomized controlled trialA study of test accuracy with: an independent, blinded comparison with a valid reference standard, among non-consecutive persons with a defined clinical presentation A prospective cohort study A prospective cohort studyA randomized controlled trial
III-1A pseudorandomized controlled trial (i.e. alternate allocation or some other method)A study of test accuracy with: an independent, blinded comparison with a valid reference standard, among non-consecutive persons with a defined clinical presentation All or none All or none A pseudorandomized controlled trial (i.e. alternate allocation or some other method)
III-2A comparative study with concurrent controls: A comparison with reference standard that does not meet the criteria required for Level II and III-1 evidenceAnalysis of prognostic factors amongst persons in a single arm of a randomized controlled trialA retrospective cohort studyA comparative study with concurrent controls:
III-3A comparative study without concurrent controls: Diagnostic case-control Study A retrospective cohort studyA case-control studyA comparative study without concurrent controls:
IVCase series with either post-test or pre-test/post-test outcomesStudy of diagnostic yield (no reference standard) Case series, or cohort study of persons at different stages of diseaseA cross-sectional study or case seriesCase series

Explanatory notes

Definitions of these study designs are provided on pages 7-8 How to use the evidence: assessment and application of scientific evidence (NHMRC 2000b) and in the accompanying Glossary.

These levels of evidence apply only to studies of assessing the accuracy of diagnostic or screening tests. To assess the overall effectiveness of a diagnostic test there also needs to be a consideration of the impact of the test on patient management and health outcomes (Medical Services Advisory Committee 2005, Sackett and Haynes 2002). The evidence hierarchy given in the ‘Intervention’ column should be used to assess the impact of a diagnostic test on health outcomes relative to an existing method of diagnosis/comparator test(s). The evidence hierarchy given in the ‘Screening’ column should be used to assess the impact of a screening test on health outcomes relative to no screening or opportunistic screening.

If it is possible and/or ethical to determine a causal relationship using experimental evidence, then the ‘Intervention’ hierarchy of evidence should be utilised. If it is only possible and/or ethical to determine a causal relationship using observational evidence (eg. cannot allocate groups to a potential harmful exposure, such as nuclear radiation), then the ‘Aetiology’ hierarchy of evidence should be utilised.

A systematic review will only be assigned a level of evidence as high as the studies it contains, excepting where those studies are of level II evidence. Systematic reviews of level II evidence provide more data than the individual studies and any meta-analyses will increase the precision of the overall results, reducing the likelihood that the results are affected by chance. Systematic reviews of lower level evidence present results of likely poor internal validity and thus are rated on the likelihood that the results have been affected by bias, rather than whether the systematic review itself is of good quality. Systematic review quality should be assessed separately. A systematic review should consist of at least two studies. In systematic reviews that include different study designs, the overall level of evidence should relate to each individual outcome/result, as different studies (and study designs) might contribute to each different outcome.

The validity of the reference standard should be determined in the context of the disease under review. Criteria for determining the validity of the reference standard should be pre-specified. This can include the choice of the reference standard(s) and its timing in relation to the index test. The validity of the reference standard can be determined through quality appraisal of the study (Whiting et al 2003).

Well-designed population based case-control studies (eg. population based screening studies where test accuracy is assessed on all cases, with a random sample of controls) do capture a population with a representative spectrum of disease and thus fulfil the requirements for a valid assembly of patients. However, in some cases the population assembled is not representative of the use of the test in practice. In diagnostic case-control studies a selected sample of patients already known to have the disease are compared with a separate group of normal/healthy people known to be free of the disease. In this situation patients with borderline or mild expressions of the disease, and conditions mimicking the disease are excluded, which can lead to exaggeration of both sensitivity and specificity. This is called spectrum bias or spectrum effect because the spectrum of study participants will not be representative of patients seen in practice (Mulherin and Miller 2002).

At study inception the cohort is either non-diseased or all at the same stage of the disease. A randomised controlled trial with persons either non-diseased or at the same stage of the disease in both arms of the trial would also meet the criterion for this level of evidence.

All or none of the people with the risk factor(s) experience the outcome; and the data arises from an unselected or representative case series which provides an unbiased representation of the prognostic effect. For example, no smallpox develops in the absence of the specific virus; and clear proof of the causal link has come from the disappearance of small pox after large-scale vaccination.

This also includes controlled before-and-after (pre-test/post-test) studies, as well as adjusted indirect comparisons (ie. utilise A vs B and B vs C, to determine A vs C with statistical adjustment for B).

Comparing single arm studies ie. case series from two studies. This would also include unadjusted indirect comparisons (ie. utilise A vs B and B vs C, to determine A vs C but where there is no statistical adjustment for B).

Studies of diagnostic yield provide the yield of diagnosed patients, as determined by an index test, without confirmation of the accuracy of this diagnosis by a reference standard. These may be the only alternative when there is no reliable reference standard.

Note A : Assessment of comparative harms/safety should occur according to the hierarchy presented for each of the research questions, with the proviso that this assessment occurs within the context of the topic being assessed. Some harms (and other outcomes) are rare and cannot feasibly be captured within randomised controlled trials, in which case lower levels of evidence may be the only type of evidence that is practically achievable; physical harms and psychological harms may need to be addressed by different study designs; harms from diagnostic testing include the likelihood of false positive and false negative results; harms from screening include the likelihood of false alarm and false reassurance results.

Note B: When a level of evidence is attributed in the text of a document, it should also be framed according to its corresponding research question eg. level II intervention evidence; level IV diagnostic evidence; level III-2 prognostic evidence.

Note C: Each individual study that is attributed a “level of evidence” should be rigorously appraised using validated or commonly used checklists or appraisal tools to ensure that factors other than study design have not affected the validity of the results.

Source: Hierarchies adapted and modified from: NHMRC 1999; Bandolier 1999; Lijmer et al. 1999; Phillips et al. 2001.

From: Appendix B, Using Six Different Frameworks To Assess the Evidence for Three Examples of Health Interventions or Programs

  • Cite this Page Shekelle PG, Maglione MA, Luoto J, et al. Global Health Evidence Evaluation Framework [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Jan. Table B.9, NHMRC Evidence Hierarchy: designations of ‘levels of evidence’ according to type of research question (including explanatory notes)
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Revision of the Australian guidelines to reduce health risks from drinking alcohol

Affiliations.

  • 1 Royal Prince Alfred Hospital, Sydney, NSW.
  • 2 University of Sydney, Sydney, NSW.
  • 3 University of Adelaide, Adelaide, SA.
  • 4 University of Melbourne, Melbourne, VIC.
  • 5 National Drug Research Institute, Curtin University, Perth, WA.
  • 6 Menzies School of Health Research, Darwin, NT.
  • 7 Centre for Primary Health Care and Equity, University of New South Wales, Sydney, NSW.
  • 8 Centre for Healthcare Transformation, Queensland University of Technology, Brisbane, QLD.
  • 9 Turning Point, Eastern Health, Melbourne, VIC.
  • 10 Monash Addiction Research Centre, Monash University, Melbourne, VIC.
  • 11 Telethon Kids Institute, Perth, WA.
  • 12 Office of the Chief Psychiatrist of Western Australia, Perth, WA.
  • 13 Drug Policy Modelling Program, Social Policy Research Centre, UNSW Sydney, Sydney, NSW.
  • 14 Aboriginal Drug and Alcohol Council SA, Aboriginal Corporation, Adelaide, SA.
  • 15 National Health and Medical Research Council, Canberra, ACT.
  • 16 National Centre for Epidemiology and Population Health, Australian National University, Canberra, ACT.
  • PMID: 34839537
  • PMCID: PMC9299166
  • DOI: 10.5694/mja2.51336

Introduction: The Australian guidelines to reduce health risks from drinking alcohol were released in 2020 by the National Health and Medical Research Council. Based on the latest evidence, the guidelines provide advice on how to keep the risk of harm from alcohol low. They refer to an Australian standard drink (10 g ethanol).

Recommendations: •Guideline 1: To reduce the risk of harm from alcohol-related disease or injury, healthy men and women should drink no more than ten standard drinks a week and no more than four standard drinks on any one day. The less you drink, the lower your risk of harm from alcohol. •Guideline 2: To reduce the risk of injury and other harms to health, children and people under 18 years of age should not drink alcohol. •Guideline 3: To prevent harm from alcohol to their unborn child, women who are pregnant or planning a pregnancy should not drink alcohol. For women who are breastfeeding, not drinking alcohol is safest for their baby.

Changes as result of the guideline: The recommended limit for healthy adults changed from two standard drinks per day (effectively 14 per week) to ten per week. The new guideline states that the less you drink, the lower your risk of harm from alcohol. The recommended maximum on any one day remains four drinks (clarified from previously "per drinking occasion"). Guidance is clearer for pregnancy and breastfeeding, and for people aged less than 18 years, recommending not drinking.

Keywords: Alcohol-related disorders; Health communication; Policy, drugs and alcohol; Prevention and control; Preventive medicine.

© 2021 The Authors. Medical Journal of Australia published by John Wiley & Sons Australia, Ltd on behalf of AMPCo Pty Ltd.

PubMed Disclaimer

Conflict of interest statement

Until December 2020, Michael Livingston was deputy director of the Centre for Alcohol Policy Research at La Trobe University, which received core funding from the Foundation for Alcohol Research and Education (FARE), a not‐for‐profit organisation working towards an Australia free from alcohol harms.

Source: National Health and Medical Research Council.

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  • 17 October 2022
  • Correction 19 October 2022

‘Game-changing’ gender quotas introduced by Australian research agency

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In an attempt to achieve gender equity, Australia’s leading health and medical research funding organization plans to award half of its research grants for its largest funding programme to women and non-binary applicants, starting next year.

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doi: https://doi.org/10.1038/d41586-022-03285-4

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Correction 19 October 2022 : An earlier version of this story left out that grants under the initiative will be fixed at Aus$400,000 each a year for five years.

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