Objective. To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of d

http://www.immpact.org/static/publications/Turk%20et%20al.,%202003.pdf

Core outcome domains for chronic pain clinical trials: IMMPACT recommendations.

Randomised controlled trials are widely accepted as the most reliable method of determining effectiveness, but most trials have evaluated the effects of a single intervention such as a drug. Recognition is increasing that other, non-pharmacological interventions should also be rigorously evaluated.1-3 This paper examines the design and execution of research required to address the additional problems resulting from evaluation of complex interventions—that is, those “made up of various interconnecting parts.”4 The issues dealt with are discussed in a longer Medical Research Council paper (www.mrc.ac.uk/complex_packages.html). We focus on randomised trials but believe that this approach could be adapted to other designs when they are more appropriate.

#### Summary points

Complex interventions are those that include several components

The evaluation of complex interventions is difficult because of problems of developing, identifying, documenting, and reproducing the intervention

A phased approach to the development and evaluation of complex interventions is proposed to help researchers define clearly where they are in the research process

Evaluation of complex interventions requires use of qualitative and quantitative evidence

There are specific difficulties in defining, developing, documenting, and reproducing complex interventions that are subject to more variation than a drug. A typical example would be the design of a trial to evaluate the benefits of specialist stroke units. Such a trial would have to consider the expertise of various health professionals as well as investigations, drugs, treatment guidelines, and arrangements for discharge and follow up. Stroke units may also vary in terms of organisation, management, and skill mix. The active components of the stroke unit may be difficult to specify, making it difficult to replicate the intervention. The box gives other examples of complex interventions.

#### Examples of complex interventions

Service delivery and organisation:

Stroke units

Hospital at home

Interventions directed at health professionals' behaviour:

Strategies for implementing guidelines

Computerised decision support

Community interventions:

Community …

https://www.bmj.com/content/bmj/321/7262/694.full.pdf

Framework for design and evaluation of complex interventions to improve health

http://www.immpact.org/static/publications/Dworkin%20et%20al.,%202005.pdf

Topical Review and RecommendationsCore outcome measures for chronic pain clinical trials: IMMPACT recommendations

The prevention of injury associated with falls in older people is a public health target in many countries around the world. Although there is good evidence that interventions such as multifactorial fall prevention and individually prescribed exercise are effective in reducing falls, the effect on serious injury rates is unclear. Historically, trials have not been adequately powered to detect injury endpoints, and variations in case definition across trials have hindered meta-analysis. It is possible that fall-prevention strategies have limited effect on falls that result in injuries or are ineffective in populations who are at a higher risk of injury. Further research is required to determine whether fall-prevention interventions can reduce serious injuries. Prevention of Falls Network Europe (ProFaNE) is a collaborative project to reduce the burden of fall injury in older people through excellence in research and promotion of best practice (www.profane.eu.org). The European Commission funds the network, which links clinicians, members of the public, and researchers worldwide. The aims are to identify major gaps in knowledge in fall injury prevention and to facilitate the collaboration necessary for large-scale clinical research activity, including clinical trials, comparative research, and prospective meta-analysis. Work is being undertaken in a 4-year program. As a first step, the development of a common set of outcome definitions and measures for future trials or meta-analysis was considered.

Development of a Common Outcome Data Set for Fall Injury Prevention Trials: The Prevention of Falls Network Europe Consensus

Purpose—The aim of this guideline is to provide a synopsis of best clinical practices in the rehabilitative care of adults recovering from stroke. Methods—Writing group members were nominated by th...

Guidelines for Adult Stroke Rehabilitation and Recovery: A Guideline for Healthcare Professionals from the American Heart Association/American Stroke Association

s. Outcome research 249 Questionnaire 63,152 Would pick up refer-

Evaluating patient-based outcome measures for use in clinical trials.

https://njl-admin.nihr.ac.uk/document/download/2002723

Claire Davey

Papers

Evaluating patient-based outcome measures for use in clinical trials.

Evaluating patient-based outcome measures for use in clinical trials: a review

Criteria for Assessing Patient Based Outcome Measures for Use in Clinical Trials