Finding the guideline that fits the study
The appropriate reporting guideline depends on the research question, study design and part of the report being prepared. A general study-type checklist may need an extension or more specialised guidance.
Research question and study design
Guideline selection needs to be tailored to the research topic and the particular study rather than answered by one recommendation for every non-interventional study or clinical investigation plan. Writers need to know the available guidelines and practise choosing and using those that fit their needs. Guidance exists for observational studies and particular observational designs, nonrandomised trials, case reports or series, and diagnostics.
Older guidance can remain useful where the methodology has not changed. The EQUATOR resource centre offers links to relevant reporting guidelines across medical research. Some guidance is still under development and needs to be sought online.
Study-type checklists
The following checklist guidelines cover different study types.
| Guideline | Study type |
|---|---|
| CONSORT and its extensions | Randomised controlled trials |
| STROBE | Observational studies |
| PRISMA, including a flow diagram | Systematic reviews and meta-analyses |
| MOOSE | Systematic reviews and meta-analyses of observational studies |
| SQUIRE | Quality-improvement studies |
| STARD | Diagnostic studies |
| ORION | Infection-control interventions |
| TREND | Nonrandomised evaluations of behavioural and public health interventions |
The CONSORT statement is intended for randomised trials but can be adapted to other designs. PRISMA was described in 2012 as mainly intended for reviews and meta-analyses of randomised clinical studies, with adaptation possible for other study types. At that time, MOOSE had not been updated since its original publication in 2000, so referring to PRISMA as well was suggested to help ensure completeness when reporting reviews or meta-analyses of observational studies.
Specialised guidance and extensions
Guidance need not have an accompanying checklist to be useful. Two examples identified in 2010 were “Setting the Bar in Phase II Trials: The Use of Historical Data for Determining ‘Go/No Go’ Decisions for Definitive Phase II Testing” for historical controls, and “Good Research Practices for Cost-Effectiveness Analysis Alongside Clinical Trials” for economic studies conducted alongside trials.
RECORD addresses studies using observational routinely collected health data and extends STROBE. CONSORT extensions published in 2008 covered abstracts in journals and conference proceedings and trials assessing nonpharmacologic treatments, including surgery, rehabilitation, psychotherapy, medical devices and complementary medicine. The abstract guidance applies to randomised trials, so work across other designs needs additional guidance.