Literature DB >> 16973532

Pragmatic randomised controlled trials in parenting research: the issue of intention to treat.

Karen Whittaker1, Chris Sutton, Chris Burton.   

Abstract

STUDY
OBJECTIVE: To evaluate trials of parenting programmes, regarding their use of intention to treat (ITT).
DESIGN: Individual trials included in two relevant Cochrane systematic reviews were scrutinised by two independent reviewers. Data on country of origin, target audience, trial type, treatment violations, use of ITT, and the management of missing data were extracted. MAIN
RESULTS: Thirty trial reports were reviewed. Three reported the use of an ITT approach to data analysis. Nineteen reported losing subjects to follow up although the implications of this were rarely considered. Insufficient detail in reports meant it was difficult to identify study drop outs, the nature of treatment violations, and those failing to provide outcome assessments. In two trials, study drop outs were considered as additional control groups, violating the basic principle of ITT.
CONCLUSIONS: It is recommended that future trial reports adhere to CONSORT guidelines. In particular ITT should be used for the main analyses, with strategies for managing treatment violations and handling missing data being reported a priori. Those conducting trials need to acknowledge the social nature of these programmes can sometimes result in erratic parent attendance and participation, which would only increase the chances of missing data. The use of approaches that can limit the proportion of missing data is therefore recommended.

Mesh:

Year:  2006        PMID: 16973532      PMCID: PMC2566053          DOI: 10.1136/jech.2005.044214

Source DB:  PubMed          Journal:  J Epidemiol Community Health        ISSN: 0143-005X            Impact factor:   3.710


  37 in total

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Authors:  D Moher; K F Schulz; D G Altman
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Review 2.  What is meant by intention to treat analysis? Survey of published randomised controlled trials.

Authors:  S Hollis; F Campbell
Journal:  BMJ       Date:  1999-09-11

3.  Intention to treat analysis is related to methodological quality.

Authors:  M Ruiz-Canela; M A Martínez-González; J de Irala-Estévez
Journal:  BMJ       Date:  2000-04-08

4.  Commentary: the Journal of Pediatric Psychology should adopt the CONSORT statement as a way of improving the evidence base in pediatric psychology.

Authors:  Patrick J McGrath; Jennifer Stinson; Karina Davidson
Journal:  J Pediatr Psychol       Date:  2003 Apr-May

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6.  Attitudes in clinical trials.

Authors:  P Armitage
Journal:  Stat Med       Date:  1998-12-15       Impact factor: 2.373

7.  Are community health interventions evaluated appropriately? A review of six journals.

Authors:  P J Smith; M E Moffatt; S C Gelskey; S Hudson; K Kaita
Journal:  J Clin Epidemiol       Date:  1997-02       Impact factor: 6.437

8.  Improving mental health through parenting programmes: block randomised controlled trial.

Authors:  J Patterson; J Barlow; C Mockford; I Klimes; C Pyper; S Stewart-Brown
Journal:  Arch Dis Child       Date:  2002-12       Impact factor: 3.791

9.  Effects of an educational intervention on mothers of male children with attention deficit hyperactivity disorder.

Authors:  S E Odom
Journal:  J Community Health Nurs       Date:  1996       Impact factor: 0.974

10.  The role of parent training in treatment of preschoolers with ADDH.

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4.  Improving the reporting of pragmatic trials: an extension of the CONSORT statement.

Authors:  Merrick Zwarenstein; Shaun Treweek; Joel J Gagnier; Douglas G Altman; Sean Tunis; Brian Haynes; Andrew D Oxman; David Moher
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  4 in total

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