The shortcomings of cluster-randomized controlled trials for the assessment of complex interventions in general practices: a systematic review

Project Summary Title and Description

The shortcomings of cluster-randomized controlled trials for the assessment of complex interventions in general practices: a systematic review
Authors of Report
Methodology description
PMID: 29111470
Funding Source
This review will be funded by German Federal Ministry of Education and Research (FKZ: 01KG1504); approval date: 05/2015

Key Questions

1. The primary objective of the study is to assess outcomes and methodological bias when cluster randomized controlled trials are used to examine complex interventions versus routine care in a general practice setting, irrespective of the disease, by: Summarizing the evidence from c-RCTs to describe the distribution of estimates of treatment effect with respect to direction (in favour of the complex intervention or the routine care treatments), magnitude (size of the effect) and statistical significance (or confidence interval). Evaluating how frequently complex interventions in c-RCTs are shown to be statistically superior to routine care. Exploring the extent to which methodological (e.g. power calculations and intraclass correlation coefficients (ICC)) and other factors (e.g. ethical approval, sponsorship) might explain differences in the distribution of c-RCTs that reach or do not reach statistical significance.

Associated Extraction Forms

Associated Studies (each link opens a new tab)

Chronic care clinics: a randomized controlled trial of a new model of primary care for frail older adults.1999
Economic evaluation of a primary care-based education programme for patients with osteoarthritis of the knee.1999
Chronic care clinics for diabetes in primary care: a system-wide randomized trial.2001
Self-management of asthma in general practice, asthma control and quality of life: a randomised controlled trial.2003
A pragmatic cluster randomized controlled trial of an educational intervention for GPs in the assessment and management of depression.2004
A chronic disease management programme can reduce days in hospital for patients with chronic obstructive pulmonary disease.2004
Self-management plans in the primary care of patients with chronic obstructive pulmonary disease.2006
Case management for depression by health care assistants in small primary care practices: a cluster randomized trial.2009
Implementation of self management support for long term conditions in routine primary care settings: cluster randomised controlled trial.2013
Effect of tailored practice and patient care plans on secondary prevention of heart disease in general practice: cluster randomised controlled trial.2009
Should treatment of (sub)acute low back pain be aimed at psychosocial prognostic factors? Cluster randomised clinical trial in general practice.2005
Effectiveness of counselling patients on physical activity in general practice: cluster randomised controlled trial.2003
General practice based intervention to prevent repeat episodes of deliberate self harm: cluster randomised controlled trial.2002
Randomised controlled trial of structured personal care of type 2 diabetes mellitus.2001
Improving the health behaviours of elderly people: randomised controlled trial of a general practice education programme.1999
Preventing injuries in children: cluster randomised controlled trial in primary care.1999
Primary care management of major depression in patients aged > or =55 years: outcome of a randomised clinical trial.2008
Exploratory cluster randomised controlled trial of shared care development for long-term mental illness.2004
Effectiveness of integrated disease management for primary care chronic obstructive pulmonary disease patients: results of cluster randomised trial.2014
Effectiveness of a training course for general practice nurses in motivation support in type 2 diabetes care: a cluster-randomised trial.
The Teamwork Study: enhancing the role of non-GP staff in chronic disease management in general practice.2013
The at-risk registers in severe asthma (ARRISA) study: a cluster-randomised controlled trial examining effectiveness and costs in primary care.2012
Dementia care in the general practice setting: a cluster randomized trial on the effectiveness and cost impact of three management strategies.2012
Effect of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with type 2 diabetes detected by screening (ADDITION-Europe): a cluster-randomised trial.2011
Systematic care for asthma in Australian general practice: a randomised controlled trial.2010
Educational outreach to general practitioners reduces children's asthma symptoms: a cluster randomised controlled trial.2007
A randomized controlled trial of brief training in the assessment and treatment of somatization in primary care: effects on patient outcome.2007
Effectiveness of interdisciplinary primary care approach to reduce disability in community dwelling frail older people: cluster randomised controlled trial.2013
Effect of a comprehensive intervention program targeting general practice staff on quality of life in patients at high cardiovascular risk: a randomized controlled trial.2004

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