BIRCH recommends using internationally recognised, high-quality research frameworks, protocols and tools in the design and execution of your research. A selection is included below. Information and toolkits for codesign are also here.
SPIRIT (Standard Protocol Items; Recommendations for Interventional Trials) is an international collaboration that aims to improve the quality of clinical trial protocols through defining an evidence-based set of objectives that need to be addressed. These objectives include scientific, ethical and administrative elements that should be included in clinical trial protocols. The intention of SPIRIT 2013 is to promote transparency and a full description what is to occur as part of a particular trial. SPIRIT 2013 is not specific to clinical trials of drugs and devices and can be applied to all studies within its definition. SPIRIT is ICH-GCP consistent and supports international registration of clinical trials.
The STROBE statement is an international, collaborative initiative of epidemiologists, methodologists, statisticians, researchers and journal editors involved in the conduct and dissemination of observational studies, with the common aim of STrengthening the Reporting of OBservational studies in Epidemiology. STROBE publishes checklists for a number of observational methods: Cohort, case-control, and cross-sectional studies (combined), Cohort studies, Case-control studies,Cross-sectional studies. Although applied to observational research, the STROBE statement is set in a health research context and uses the language most commonly associated with qualitative research.
The CONSORT Statement is an evidence-based, minimum set of recommendations for reporting randomised trials using a 25-item checklist. It has been developed with a focus on randomised clinical research but is also useful for clinical trial reporting.
The CONSORT extension for randomized pilot and feasibility trials is meant to provide reporting guidance for any randomised study in which a future definitive RCT, or part of it, is conducted on a smaller scale, regardless of its design (eg, cluster, factorial, crossover) or the terms used by authors to describe the study (eg, pilot, feasibility, trial, study). There are some key differences in pilot and feasibility studies from standard randomized trials, particularly in the type of information that needs to be reported and in the interpretation of standard CONSORT reporting items.
There has been no single or well-accepted international standard for reporting of qualitative results therefore, the 32-item consolidated criteria for reporting qualitative research (COREQ) was developed through the consolidation of 76 items identified in partial checklists from literature reviews. The COREQ focuses on interviews and is largely referenced by health and medical literature. It sets standards across 3 domains: 1. research team and reflexivity, 2. study design, and 3. analysis of findings.
A note on biostatistics. Statistical concepts are complex, and require careful treatment in order to accurately share the results of any biomedical study. The following article outlines five of the most common mistakes made regarding statistical reporting.
Increasingly, researchers seeking competitive grants are required to engage in a codesign process. Members of the community who have experienced the health issue under consideration either as a patient, carer, or in another capacity, participate in designing how the research project is considered, constructed and rolled out. This is a collaboration between those members of the public, staff and researchers. Ideally, codesign is not a once-off consultation, but an ongoing process. What is required of codesign panel participants varies according to the size and scope of the research.
The following resources are freely available and can be used in codesign processes. Remember, BIRCH can assist you in executing research codesign.