(Non-illness specific) Reporting bias in medical research - a narrative review

[Dolphin]

[This is not about ME/CFS specifically. It is about "reporting bias" where people may not get to know the correct results of trials for one reason or another e.g. the trial was never published, what was published was misleading or harms were hidden, etc. They give lots and lots of examples of this which might be of interest to people. Note this is different to a previous paper I highlighted which talked about types of bias http://forums.aboutmecfs.org/showth...lains)-27-types-of-publication-reporting-bias (see Tables 1 & 2 in that). People may have particular type(s) of drugs or illness they are interested in so could just look at those sections. People could skip the paper if they wanted and go straight to the list: http://bit.ly/eDSA2a i.e. http://www.trialsjournal.com/content/supplementary/1745-6215-11-37-s1.doc . A lay journalist of course would probably make the items more readable. There are probably lay articles with more details out on the internet if people wanted more details on any one example. No questions to me please!]
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Free full text: http://www.trialsjournal.com/content/11/1/37

Additional file with a list: http://bit.ly/eDSA2a i.e.
http://www.trialsjournal.com/content/supplementary/1745-6215-11-37-s1.doc

Trials. 2010 Apr 13;11:37.

Reporting bias in medical research - a narrative review.

McGauran N, Wieseler B, Kreis J, Schler YB, Klsch H, Kaiser T.

Institute for Quality and Efficiency in Health Care, Dillenburger Str 27,
51105 Cologne, Germany. n.mcgauran@iqwig.de


[I have given each line a paragraph]

Abstract

Reporting bias represents a major problem in the assessment of health care interventions.

Several prominent cases have been described in the literature, for example, in the reporting of trials of antidepressants, Class I anti-arrhythmic drugs, and selective COX-2 inhibitors.

The aim of this narrative review is to gain an overview of reporting bias in the medical literature, focussing on publication bias and selective outcome reporting.

We explore whether these types of bias have been shown in areas beyond the well-known cases noted above, in order to gain an impression of how widespread the problem is.

For this purpose, we screened relevant articles on reporting bias that had previously been obtained by the German Institute for Quality and Efficiency in Health Care in the context of its health technology assessment reports and other research work, together with the reference lists of these articles.

We identified reporting bias in 40 indications comprising around 50 different pharmacological, surgical (e.g. vacuum-assisted closure therapy), diagnostic (e.g. ultrasound), and preventive (e.g. cancer vaccines) interventions.

Regarding pharmacological interventions, cases of reporting bias were, for example, identified in the treatment of the following conditions:
depression, bipolar disorder, schizophrenia, anxiety disorder, attention-deficit hyperactivity disorder, Alzheimer's disease, pain, migraine, cardiovascular disease, gastric ulcers, irritable bowel syndrome, urinary incontinence, atopic dermatitis, diabetes mellitus type 2, hypercholesterolaemia, thyroid disorders, menopausal symptoms, various types of cancer (e.g. ovarian cancer and melanoma), various types of infections (e.g. HIV, influenza and Hepatitis B), and acute trauma.

Many cases involved the withholding of study data by manufacturers and regulatory agencies or the active attempt by manufacturers to suppress publication.

The ascertained effects of reporting bias included the overestimation of efficacy and the underestimation of safety risks of interventions.

In conclusion, reporting bias is a widespread phenomenon in the medical literature.

Mandatory prospective registration of trials and public access to study data via results databases need to be introduced on a worldwide scale.

This will allow for an independent review of research data, help fulfil ethical obligations towards patients, and ensure a basis for fully-informed decision making in the health care system.

PMID: 20388211 [PubMed - indexed for MEDLINE]