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How do we know? Reported Trials of China, RCTs, the CONSORT Statement

A recent "Trials" paper (authors from China, UK )

[critically evaluates] RCTs conducted in China based on studies published in 2004... to describe their general characteristics, evaluate the quality of their reporting and evaluate their conduct where adequately reported.(1)
The paper observes that China is a developing country with the largest population in the world, research in China has been rapidly gaining momentum but as yet there is no systematic evaluation of the current standard of trials conducted there.
'Randomized controlled trials' (RCTs) are considered the 'gold standard' for assessing the effectiveness of pharmacological and other interventions in the field of medicine and are widely accepted as the best research design because they distribute both known and unknown prognostic factors between treatment groups by the play of chance thereby minimizing the possibility that any treatment effect is due to bias or confounding and providing the basis for valid statistical comparison. However RCTs vary in their methodology rigor and it is well known that poor quality studies tend to produce systematically different results from larger better quality studies, often erroneously showing larger treatment effects. The conduct of studies cannot be assessed without clear reporting.
RCTs published in 2004 were reviewed--as identified through PubMed database, and on-line versions of main medical journals in China-- about 71 journals.
A 2008 JAMA Editorial discusses requirements for publication of clinical trials in JAMA
-all RCTs to be registered in a public trials registry that is acceptable to the International Committee of Medical Journals and that requires the minimum registration data set as described by the ICMJE,
-authors of clinical trials should follow the CONSORT guidelines for reporting RCT results, and
-for all RCTs data anaylsis must be conducted by an academic statistician.(2)
Authors from the UK, Canada, USA published a recent paper in "Trials" entitled: "Endorsement of the CONSORT Statement by high impact factor medical journals: a survey of journal editors and journal 'Instructions to Authors' "(3) which indicates that the CONSORT Statement provides recommendations for reporting RCTs, and Journals should be more explicit in their recommendations and expectations for authors regarding the CONSORT Statement and related CONSORT extensions papers.
CONSORT (Consolidated Standards of Reporting Trials)
encompasses various initiatives developed by the CONSORT Group to alleviate the problems arising from inadequate reporting of RCTs. The CONSORT Statement, is an evidence-based, minimum set of recommendations for reporting RCTs. (4) ...It offers a standard way for authors to prepare reports of trial findings, facilitating their complete and transparent reporting, and aiding their critical appraisal and interpretation. The CONSORT Statement comprises a 22-item checklist and a flow diagram, along with some brief descriptive text... The CONSORT Statement is available in 10 different languages other than English.

See also AHRQ 's "Systems to Rate the Strength of Scientific Evidence" (5)- a description of systems used to rate the strength of scientific evidence. Valuable information gleaned from 1602 articles, reports,... indicates that overall many systems covered most of the domains that are considered generally informative for assessing study quality.
Some background: From a 2000 JAMA article "Meta-analysis of Observational Studies in Epidemiology-a Proposal for Reporting", by the MOOSE group
,...because of pressure for timely and informed decisions in public health and medicine and the explosion of information in scientific literature, research results must be synthesized to answer urgent questions. Principles of evidence-based methods to assess the effectiveness of health care interventions, set policy, are cited increasingly
.(6)
(1) http://www.trialsjournal.com/content/pdf/1745-6215-9-22.pdf
"Trials" via BIOMED Central on line: "An Assessment of the quality of randomized controlled trials (RCTs) conducted in China" by authors from China and the UK" D. Zhang, P. Yin, N. Freemantle, R. Jordan, N. Zhong,l K. Cheng
(2) http://jama.ama-assn.org/cgi/reprint/299/1/95?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=JAMA+Instructions+for+Authors+2006&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT
http://jama.ama-assn.org/cgi/reprint/295/1/103?maxtoshow=&HITS=10&hits=10&RESULTFORMAT=&fulltext=JAMA+Instructions+for+Authors+2006&searchid=1&FIRSTINDEX=0&resourcetype=HWCITJAMA Jan 4 2006 vol 295 no 1 instructions to authors
(3)http://www.trialsjournal.com/content/pdf/1745-6215-9-20.pdf authors S. Hopewell, D. Altman, D. Moher, K.Schulz
(4) http://www.consort-statement.org/index.aspx?o=1056 who is
(5)http://www.fda.gov/ohrms/dockets/dockets/04q0083/04q-0083-pdn0001-03-Tab-01-AHRQ-vol9.pdf
(6) http://jama.ama-assn.org/cgi/reprint/283/15/2008? JAMA Vol 283, No 15

One of many observations: only 10.8 % of the included Chinese trials reported approval by an ethics committee. The majority of the study reports did not provide any information about informed consent although 17.6% of the papers stated that the participants did give consent.

The CONSORT Group (see website for supporters/funding info) announced the publication of a new extension to the CONSORT Statement for reporting randomized controlled trials (RCTs) assessing non-pharmacologic treatments (NPT). NPT concerns a wide range of treatments such as surgery, technical interventions, rehabilitation, psychotherapy, behavioral interventions, implantable and non-implantable devices and complementary medicine. Assessing these treatments raises specific issues such as difficulties of blinding, complexity of the intervention and influence of care providers’ expertise and volume of care of centers on treatment effect. These issues are inadequately reported in published RCTs.
2006 JAMA article "JAMA Instructions for Authors-'Reports of Clinical Trials'" (2) indicates that:
manuscripts reporting results of RCTs should include the CONSORT flow diagram showing the progress of the patient throughout the trial. The CONSORT checklist should also be completed and submitted with the manuscript. http://jama.ama-assn.org/cgi/content/full/2951/1/103/DC1 and submitted with the manuscript.
Meta-analysis is a systematic approach to identifying, appraising, synthesizing and, if appropriate, combining results of relevant studies to arrive at conclusions about a body of research has been applied with increasing frequency to RCTs which are considered to provide the strongest evidence regarding an intervention. However in many situations RCT designs are not feasible and only data from observational studies are available. They propose a checklist containing specifications for reporting of meta analyses of observational studies in epidemiology
.

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