While some of the missing detail is intrinsic to the complexity of certain treatments, providing some additional and readily available information would allow a greater use of published research in clinical practice. Many authors were willing to provide extra details and materials so that their treatment could be used, but clearly this had not been required by most journals.
So how might reporting be improved? For trials, the CONSORT statement asks for “Precise details of the treatments intended for each group and how and when they were actually administered,”10
but further guidance would be helpful. A more detailed checklist about the “who, what, when, and where” of the treatment is desirable but may need to be tailored to different types of interventions. For non-pharmacological treatments the details are often complex, and a recent extension to CONSORT (available at www.consort-statement.org/index.aspx?o=1068
) requests extra details on the components, the procedure, including tailoring to individuals, standardisation, and adherence.
Full descriptions of treatment should include any procedures used; the timing of treatment, including duration and intervals of dosing or sessions; any materials needed (such as patient handouts or devices); and accessibility of any materials or instructions, including overcoming language barriers. This may need to be supplemented with graphical methods for depicting the flow and timing of sessions of treatment11
and copies of materials or handouts used. Electronic publishing provides the ideal format for distributingsuch extra material.12
For systematic reviews, statistical and clinical approaches need to be integrated to help reviewers select the most appropriate treatment(s) from among those included in the review.
In systematic reviews, the high level of abstraction used in selecting “similar” treatments causes a problem. Even when reviews and trials include enough details of the treatment, the clinical reader may find it difficult to select the version to adopt in practice, especially if there is heterogeneity of effect among the treatments. Several formal and informal options can be used to decide the appropriate treatment in practice. For example, selecting the treatment with the largest apparent benefit seems sensible but has several dangers. In particular, a small trial may have a large effect by chance. The treatment used in the largest trial is not necessarily the most effective one. The QUOROM statement asks reviewers to report “details of intervention” of trials,13
and the Cochrane Handbook
provides more on how to describe complex interventions (Section 7.3.4) and their fidelity,14
but neither currently gives guidance on how to select and report the appropriate versions of the treatments reviewed.
Access to such complete descriptions should not be restricted. Development of a repository of treatment descriptions, particularly for non-drug treatments, would help clinicians and be supported by many authors. An example of such a process is the Centers for Disease Control and Prevention’s Replicating Effective Programs (www.cdc.gov/hiv/projects/rep
), which aims to provide detailed packages and resources in HIV prevention. Without such descriptions and programmes, tens of millions of pounds of research effort could be wasted each year because effective treatments can’t be implemented or will lack fidelity when applied.
- To use treatments tested in trials, clinicians need sufficient details of the “how to”
- Many current trials and reviews often omit crucial details of treatments
- Providing some additional treatment details could improve the uptake of trial results in clinical practice