Accurate reporting is a prerequisite for critical interpretation of any research study and its findings. Without accurate reporting it is not possible to assess the merits of a study. Any positive findings of basic research experiments on high dilutions or potencies are likely to stir controversy in the academic community. If details in the publication (or an additional accessible report) are insufficient to allow repetition of experiments performed or to assess potential threats to validity, the value of a potentially important experiment is strongly compromised. In an 18-month Delphi process we have tried to come up with a checklist aimed at helping authors to prepare high quality manuscripts on their homeopathic basic research experiments, and at helping peer reviewers, editors and readers to check whether reporting accurately reflects their experiments.
Shortcomings in reporting experiments are not at all unique to homeopathy but a general phenomenon. The limited space in journals, specific style and editorial pressure often force authors to shorten their paper to an extent where a detailed description becomes impossible. However, even with limited space, a good manuscript can provide a lot of relevant details, and the internet makes it possible to make more detailed reports easily available to interested researchers. In clinical and epidemiological research several checklists to improve reporting quality have been developed within the last number of years. The first attempt to improve quality of reporting randomized clinical trials was the CONSORT statement in 1996 [14
]. This document has been revised in 2001 [12
] and 2005 [15
], and recently further documents have become available for improving the reporting of abstracts [16
], pragmatic trials [17
], non-pharmacological trials [18
] (see also http://www.consort-statement.org/
). The necessity of CONSORT was recently encouraged by the poor standards common in reporting RCTS in Tai Chi interventions [19
] as well as the poor standard of reporting in Chinese journals [20
QUORUM provides a guideline for reporting meta-analyses [21
]. An evolution of this guideline was developed by an international group: Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) [23
]. For observational studies, including cohort, case-control and cross-sectional studies STROBE emerged [13
], recently extended with STREGA (STRengthening the Reporting of Genetic Association studies) [24
]. Comparable lists are available for trials in acupuncture: STRICTA [25
] is already discussed [26
] and assessed [27
]. For complete and accurate reporting of studies of diagnostic accuracy (STARD) an item list was compiled [28
]. Standards for Quality Improvement Reporting Excellence (SQUIRE) were published to enhance reporting on quality improvement studies in health care [29
]. RedHot [30
], an unofficial extension for CONSORT, was established to assist reporting on homeopathic treatments in clinical trials. A further CONSORT statement was compiled [31
] concerning randomized, controlled trials of herbal interventions, evaluated in a systematic review of instruments developed to critically assess the quality of trials on the efficacy of natural health products [32
]. A complete collection of available reporting guidelines can be found at EQUATOR (Enhancing the QUAlity and Transparency Of health Research), a new international initiative based on a network concept [33
Basic research is different from clinical and epidemiological research, and reporting guidelines comparable to those described above for clinical research do not exist in this area outside of homeopathy. In biological sciences there are some groups working on standards of data presentation. These initiatives were derived from research groups dealing with microarray experiments and provide several checklists on how to report and deal with large numbers of data [34
]. An overview of these activities can be found at the homepage of MIBBI (Minimum Information for Biological and Biomedical Investigations) http://www.mibbi.org
or the MGED (Microarray Gene Expression Data
Our checklist is compiled for experiments on homeopathy and how to report each step of experiment which is important to understand and appreciate the results.
A first proposal for a reporting guideline in homeopathy was introduced in 1991 [35
]. It focused on experiments dealing with ultra low dose effects (serial dilutions and potencies).
The group refrained from establishing a score for assessing quality, as had been common in the past, in clinical research [36
]. In the current state it was thought that it is not feasible to propose clear-cut criteria for assessing what constitutes good and bad basic research beyond generally accepted standards. Furthermore, a lot of basic research experiments are explorative and often procedures cannot follow a predictable outline. Research questions tend to be more complex than the methodologically straightforward question of efficacy. Unexpected effects are common, either due to the potentization process, the level of potentization or the substance itself. In exploratory experiments it is often not obvious to which part of the intervention the effect refers to and to what extent. A precise description of the manufacturing and the Pharmacopoeias of the test and control substances are therefore indispensable. If the expected effect is caused by the succussion process only, unpotentized solvent is the adequate control. If the effect is expected to be caused by a potentized substance, a potentized solvent or another potentized substance (at the same potency level) is adequate. When investigation was performed on the Similia Principle, a variety of substances, which represent different degrees of similarity with the diseased state, can be chosen as control. It is important to explain why which control was selected relating to the underlying questions of research, for example, the Similia Principle or Isopathy. In this context the role of individualization in experiments performed about the Similia Principle or the definition of Isopathy should be taken into account.
Whether quality assessment scores make sense in the future remains to be discussed. In clinical research there is a clear trend to assess single components of quality and investigate their impact on outcomes instead of using questionable summary scores. “One commonly-used scale was developed by Jadad and colleagues for randomized trials in pain research [37
]. The use of this scale is explicitly discouraged. As well as suffering from the generic problems of scales, it has a strong emphasis on reporting rather than conduct, and does not cover one of the most important potential biases in randomized trials, namely allocation concealment." (Cochrane Handbook, Chapter 8.3.3) [10
REHBaR was developed with a standard consensus method among an international team of researchers with experience in basic and clinical research in homeopathy, experimental physiology, general research methodology and statistics. All members commented on intermediate and the final version of the checklist. Obviously, the team was a relatively small sample of individuals, and other researchers might have introduced other items. The current list has to be considered as a first try and it is hoped that it proves useful to enhance the quality of reporting basic research experiments in homeopathy. We encourage the use of the list, critical feedback and hope to be able to provide an improved version in a few years.