gms | German Medical Science

Background: There are numerous methodological challenges in the development of guidelines for complex interventions. Complex interventions involve different objectives, components and actions. Temporal aspects can be present and actions can be independent or inter-dependent. As a consequence there are challenges in the synthesis and use of evidence. There has been limited discourse on these challenges among guideline developers.

Objectives: To describe some of the methodological challenges that arise when developing guidelines for complex interventions and present practical solutions using examples from guidelines on the management of return to work following injury, case management and wheelchair prescription.

Methods: Over 6 years, solutions for scoping, synthesising and grading the body of evidence were explored during the development of guidelines for complex interventions for people with traumatic brain or spinal cord injury, or rotator cuff injury. Examples include: 'unpacking' intervention components, expanding database searches and including 'grey' literature from regulatory authorities, and using mixed methodology studies.

Results: Several solutions were adopted to develop actionable recommendations. An adapted recommendation grading scale to synthesise mixed methodology studies and specific recommendation grades to accommodate 'grey' literature were developed, research evidence results were categorised, clinical tools or checklists were developed and linked to consensus methodology.

Discussion: Health interventions are increasingly complex with a focus on health domains and the person's context. Guideline methodology and transparency is paramount to ensure consistency with methodological principles and quality.

Implications: Developing guidelines on complex interventions demands creative solutions consistent with guideline development methodology. Some of the solutions could be trialled and further developed by guideline developers.