There are many useful published standards that improve the quality of all published biomedical research. One good source of information about them is the Equator Network. Many of them apply well to rehabilitation, but there has been some disquiet. The Cochrane Rehabilitation group has set up a special working party to review published standards and, if necessary, revise them. It is RCTRACK. It has just published three articles.
The first concerns the reporting of rehabilitation interventions. The approach was based closely on the existing TIDieR framework which was published in 2014. The article describes both a review and analysis of advice already published, and gives a set of specific recommendations in Table one.
From my perspective, as a researcher, as a clinician, and as a journal editor and potential reader, the level of specific detail recommended seems unrealistic. We publish descriptions using TIDieR, in our Rehabilitation in Practice series, but the detail required could not be achieved in any reasonable or readable journal article. The authors would also find it difficult to expend the time and effort.
The recommendations also make various assumptions that are not necessarily true:
- we know what the ‘active ingredient(s) of a complex intervention are;
- the classification system and theories underlying interventions are known and valid;
- readers will understand and replicate the description.
I think the effort is worthwhile, as a way of increasing thought about interventions and to help researchers and others when developing interventions. It will also greatly improve the critical evaluation of interventions, by reminding readers what needs to be considered. But it needs a warning, “what we have described may have missed many other vital ingredients, such as the personalties of the people involved and the environment involved.“
The second article concerns the quality of the reporting of outcomes. Note: this is much more than simply choosing a measures. After a review of existing work and discussion, the arrive at five key recommendations:
- “clearly describe the construct to be measured as outcome(s)“. This seems an important, relevant first step. Most people seem to start by considering specific measures, rather that what the want or need to measure. [Once, years ago, I was contacted to tell a researcher “what is the best outcome for measuring outcome in a trial on stroke patients?” and the questionnaire would not say what the intervention was, so I replied “The Frenchay Aphasia Screening Test”. After a silence, the questioner said “but we are studying physiotherapy for walking.”
- justify the selection by mapping to the WHO ICF framework. I would prefer it to say, “to the main domains within the holistic bio psychosocial model of illness”, primarily to avoid the researcher being bogged down in the details of the the classification system.
- justify the selection in terms of psychometric properties. This relates to the particular measure. When there is a choice, this seems reasonable, but it is more important to choose a measure that focuses on the data of interest that to choose a psychometrically sound measure that contains irrelevant items or is not usable.
- describe the timing of measurement, relating it to the conditions natural history of change. An eminently sensible item. Often authors assume prognosis is known by the reader.
- “complete and unselective reporting of outcome data.” Yes!
The third article concerns the framing of the research question. The authors reviewed published reports on randomised controlled trials from 11 journals. I was pleased to see that over one quarter were from Clinical Rehabilitation. The conclusion was that “that trialists in the rehabilitation field should pay attention to the proper fram- ing of the RQ using a structured approach, such as the PICO format. This should comprise a precise statement of the primary objective, ideally in a single sentence as suggested by Cochrane. “
I absolutely agree that more attention is needed to the research question. But I would add one particular question or preliminary consideration – “Is this question of any importance?” At the end of reading some well designed and well reported studies, I ask my self “but, so what?!“