Methodological issues in pragmatic trials of complex interventions in primary care

Foster, Nadine E; Little, Paul

doi:10.3399/bjgp12x616238

Cited by 32 publications

(20 citation statements)

References 13 publications

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“…Only two trials used an active comparison group, and neither of these showed any advantage for Triple P in terms of child-based outcomes. Trials with waiting list controls or usual care provide intervention estimates which reflect the combined specific and non-specific effects that will accrue in practice, and are more likely to show between-group differences than trials with active controls [35]. …”

Section: Discussionmentioning

confidence: 99%

How evidence-based is an 'evidence-based parenting program'? A PRISMA systematic review and meta-analysis of Triple P

Wilson

Rush

Hussey³

et al. 2012

BMC Med

138

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BackgroundInterventions to promote positive parenting are often reported to offer good outcomes for children but they can consume substantial resources and they require rigorous appraisal.MethodsEvaluations of the Triple P parenting program were subjected to systematic review and meta-analysis with analysis of biases. PsychInfo, Embase and Ovid Medline were used as data sources. We selected published articles reporting any child-based outcome in which any variant of Triple P was evaluated in relation to a comparison condition. Unpublished data, papers in languages other than English and some book chapters were not examined. Studies reporting Eyberg Child Behavior Inventory or Child Behavior Checklist scores as outcomes were used in the meta-analysis.ResultsA total of 33 eligible studies was identified, most involving media-recruited families. Thirty-one of these 33 studies compared Triple P interventions with waiting list or no-treatment comparison groups. Most papers only reported maternal assessments of child behavior. Twenty-three papers were incorporated in the meta-analysis. No studies involved children younger than two-years old and comparisons of intervention and control groups beyond the duration of the intervention were only possible in five studies. For maternally-reported outcomes the summary effect size was 0.61 (95%CI 0.42, 0.79). Paternally-reported outcomes following Triple P intervention were smaller and did not differ significantly from the control condition (effect size 0.42 (95%CI -0.02, 0.87)). The two studies involving an active control group showed no between-group differences. There was limited evidence of publication bias, but there was substantial selective reporting bias, and preferential reporting of positive results in article abstracts. Thirty-two of the 33 eligible studies were authored by Triple-P affiliated personnel. No trials were registered and only two papers contained conflict of interest statements.ConclusionsIn volunteer populations over the short term, mothers generally report that Triple P group interventions are better than no intervention, but there is concern about these results given the high risk of bias, poor reporting and potential conflicts of interest. We found no convincing evidence that Triple P interventions work across the whole population or that any benefits are long-term. Given the substantial cost implications, commissioners should apply to parenting programs the standards used in assessing pharmaceutical interventions.See related commentary: http://www.biomedcentral.com/1741-7015/10/145

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Section: Discussionmentioning

confidence: 99%

How evidence-based is an 'evidence-based parenting program'? A PRISMA systematic review and meta-analysis of Triple P

Wilson

Rush

Hussey³

et al. 2012

BMC Med

138

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“…Current methodology has made popular the pragmatic randomized trial (Foster & Little, 2012) and has led to an acknowledged growth of high-quality research in the 'new generation' of psychosocial interventions in dementia care (Orrell, 2012). However, many trials of psychosocial interventions in dementia lack impact.…”

Section: Introductionmentioning

confidence: 99%

“…This has often relied on the Medical Research Council's (MRC) Framework for complex interventions and its iterations (Campbell et al, 2000;Craig et al, 2008;Craig & Petticrew, 2013). Foster and Little (2012) pinpoint an important obstacle to improving clinical practice as the legacy of 'simple' drug therapy evaluations which are engrained in the design and conduct of the pragmatic trial, a view that can also be extended more generally to the interpretation and conduct of the MRC framework for complex interventions and its methodologies. The advantage of pragmatic trials is their proximity to daily practice in routine health care settings.…”

Section: Introductionmentioning

confidence: 99%

Raising the standard of applied dementia care research: addressing the implementation error

Vernooij‐Dassen

Moniz-Cook

2014

Aging & Mental Health

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“…43 A range of tools for assessing bias are available. 43,49 However many of these biases can be mitigated during the analysis of data.…”

Section: Variablementioning

confidence: 99%

What evidence is good evidence? A Masterclass in critical appraisal

Fawkes

Ward

Carnes

2015

International Journal of Osteopathic Medicine

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Methodological issues in pragmatic trials of complex interventions in primary care

Cited by 32 publications

References 13 publications

How evidence-based is an 'evidence-based parenting program'? A PRISMA systematic review and meta-analysis of Triple P

How evidence-based is an 'evidence-based parenting program'? A PRISMA systematic review and meta-analysis of Triple P

Raising the standard of applied dementia care research: addressing the implementation error

What evidence is good evidence? A Masterclass in critical appraisal

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