Framework for design and evaluation of complex interventions to improve health

Campbell, Marion K

doi:10.1136/bmj.321.7262.694

Cited by 2,851 publications

(2,521 citation statements)

References 13 publications

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“…As such, it provides not only important information for national policy developments but also the opportunity for a cross-cultural comparison of universal free breakfast provision in the UK and USA, where a similar initiative has been evaluated using a comparable design (30) . The current trial design was in part determined by policy and practice constraints, rather than by conforming to evaluation frameworks (49) that recommend theory, modelling and exploratory trial phases before the conduct of a definitive trial. Nevertheless, the present study addressed a number of methodological shortcomings identified in previous UK studies, including a lack of randomisation, the provision of appropriate control groups and contamination between trial arms (35) .…”

Section: Resultsmentioning

confidence: 99%

Free healthy breakfasts in primary schools: a cluster randomised controlled trial of a policy intervention in Wales, UK

Murphy

Moore

Tapper

et al. 2010

Public Health Nutr.

102

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Objective: The present study evaluated the impact of a national school programme of universal free healthy breakfast provision in Wales, UK. Design: A cluster randomised controlled trial with repeated cross-sectional design and a 12-month follow-up. Primary outcomes were breakfast skipping, breakfast diet and episodic memory. Secondary outcomes were frequency of eating breakfast at home and at school, breakfast attitudes, rest-of-day diet and class behaviour. Setting: Primary schools in nine local education authority areas. Subjects: A total of 4350 students (aged 9-11 years) at baseline and 4472 at follow-up in 111 schools. Results: Students in intervention schools reported significantly higher numbers of healthy food items consumed at breakfast and more positive attitudes towards breakfast eating at 12 months. Parents in intervention schools reported significantly higher rates of consumption of breakfast at school and correspondingly lower rates of breakfast consumption at home. No other significant differences were found. Conclusions: The intervention did not reduce breakfast skipping; rather, pupils substituted breakfast at home for breakfast at school. However, there were improvements in children's nutritional intake at breakfast time, if not the rest of the day, and more positive attitudes to breakfast, which may have implications for lifecourse dietary behaviours. There was no impact on episodic memory or classroom behaviour, which may require targeting breakfast skippers.

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Section: Resultsmentioning

confidence: 99%

Free healthy breakfasts in primary schools: a cluster randomised controlled trial of a policy intervention in Wales, UK

Murphy

Moore

Tapper

et al. 2010

Public Health Nutr.

102

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“…Future developments may consider incorporating PEI as a usual component of practice and evaluating its clinical effects through a phase IV study. 40 In view of the generally poor health status of subjects, it was important that outcome measures were concise so as not to overburden patients. Therefore, the current study focused on symptom intensity; other dimensions such as distress, and the impact of symptom cluster on patients' overall quality of life, were not measured.…”

Section: Discussionmentioning

confidence: 99%

Managing Symptoms in Patients with Advanced Lung Cancer During Radiotherapy: Results of a Psychoeducational Randomized Controlled Trial

Chan

Richardson

2011

Journal of Pain and Symptom Management

126

114

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(250 words)Context: Breathlessness, fatigue, and anxiety are distressing symptoms for patients with advanced lung cancer. Usually managed as isolated symptoms, they can often occur simultaneously. Previous research has often addressed management of discrete symptoms rather than considering them as a cluster, which in reality is the situation faced by patients.Objectives: This study aims to examine the effectiveness of a psychoeducational intervention (PEI) on the symptom cluster of anxiety, breathlessness and fatigue, compared with usual care. Methods:A pre-test post-test 2-group randomized controlled trial was conducted.Education on symptom management and coaching in the use of progressive muscle relaxation were delivered to patients one week prior to commencing radiotherapy (RT), and repeated 3 weeks after the first. Symptom data were collected at 4 time points: prior to the intervention, 3 weeks, 6 weeks, and 12 weeks post intervention.Results: 140 lung cancer patients receiving palliative RT were recruited from a public funded hospital in Hong Kong. Doubly multivariate MANOVA revealed a significant difference (Time *group interaction effect, p = .003) over time between the PEI and usual care control group on the pattern of change of the symptom cluster. Significant effects on the patterns of changes in breathlessness (p = .002), fatigue (p = .011), anxiety (p = .001) and functional ability (p = .000) were also found. 4Conclusions: PEI was a promising treatment for relieving the symptom cluster and each of the individually assessed symptoms. More effort needs to be directed at studying impact of interventions on common symptom clusters.

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“…Most interventions aimed at changing health behaviours are complex in that they contain multiple components (Campbell et al ., 2000; Oakley et al ., 2006). The effectiveness of face‐to‐face interventions depends on providers delivering the intervention as intended and participants engaging with the intervention.…”

Section: Introductionmentioning

confidence: 99%

Measures of fidelity of delivery of, and engagement with, complex, face‐to‐face health behaviour change interventions: A systematic review of measure quality

Walton

Spector

Tombor

et al. 2017

British J Health Psychol

199

237

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PurposeUnderstanding the effectiveness of complex, face‐to‐face health behaviour change interventions requires high‐quality measures to assess fidelity of delivery and engagement. This systematic review aimed to (1) identify the types of measures used to monitor fidelity of delivery of, and engagement with, complex, face‐to‐face health behaviour change interventions and (2) describe the reporting of psychometric and implementation qualities.MethodsElectronic databases were searched, systematic reviews and reference lists were hand‐searched, and 21 experts were contacted to identify articles. Studies that quantitatively measured fidelity of delivery of, and/or engagement with, a complex, face‐to‐face health behaviour change intervention for adults were included. Data on interventions, measures, and psychometric and implementation qualities were extracted and synthesized using narrative analysis.ResultsSixty‐six studies were included: 24 measured both fidelity of delivery and engagement, 20 measured fidelity of delivery, and 22 measured engagement. Measures of fidelity of delivery included observation (n = 17; 38.6%), self‐report (n = 15; 34%), quantitatively rated qualitative interviews (n = 1; 2.3%), or multiple measures (n = 11; 25%). Measures of engagement included self‐report (n = 18; 39.1%), intervention records (n = 11; 24%), or multiple measures (n = 17; 37%). Fifty‐one studies (77%) reported at least one psychometric or implementation quality; 49 studies (74.2%) reported at least one psychometric quality, and 17 studies (25.8%) reported at least one implementation quality.ConclusionFewer than half of the reviewed studies measured both fidelity of delivery of, and engagement with complex, face‐to‐face health behaviour change interventions. More studies reported psychometric qualities than implementation qualities. Interpretation of intervention outcomes from fidelity of delivery and engagement measurements may be limited due to a lack of reporting of psychometric and implementation qualities. Statement of contribution What is already known on this subject? Evidence of fidelity and engagement is needed to understand effectiveness of complex interventionsEvidence of fidelity and engagement are rarely reportedHigh‐quality measures are needed to measure fidelity and engagement What does this study add? Evidence that indicators of quality of measures are reported in some studiesEvidence that psychometric qualities are reported more frequently than implementation qualitiesA recommendation for intervention evaluations to report indicators of quality of fidelity and engagement measures

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Framework for design and evaluation of complex interventions to improve health

Cited by 2,851 publications

References 13 publications

Free healthy breakfasts in primary schools: a cluster randomised controlled trial of a policy intervention in Wales, UK

Free healthy breakfasts in primary schools: a cluster randomised controlled trial of a policy intervention in Wales, UK

Managing Symptoms in Patients with Advanced Lung Cancer During Radiotherapy: Results of a Psychoeducational Randomized Controlled Trial

Measures of fidelity of delivery of, and engagement with, complex, face‐to‐face health behaviour change interventions: A systematic review of measure quality

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