Accounting for intraclass correlations and controlling for baseline differences in a cluster-randomised evidence-based practice intervention study.

Background: In health care and community-based intervention studies, cluster-randomised designs have been increasingly used because of administrative convenience, a desire to decrease treatment contamination, and the need to avoid ethical issues that might arise. While useful, cluster-randomised des...

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Published in:Worldviews on Evidence-Based Nursing (Wiley-Blackwell) Vol. 5; no. 2; pp. 95 - 102
Main Authors: Xie X, Titler MG, Clarke WR
Format: clinical trial equations & formulas research Journal Article
Published: Wiley-Blackwell 2008 2nd Quarter
Online Access:View this record in EBSCOhost
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      pub: Wiley-Blackwell
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        10.1111/j.1741-6787.2008.00125.x
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        atl: Accounting for intraclass correlations and controlling for baseline differences in a cluster-randomised evidence-based practice intervention study.
      aug:
        au:
          Xie X
          Titler MG
          Clarke WR
        affil: Assistant Professor, Department of Clinical Sciences-Division of Biostatistics and Simmons Comprehensive Cancer Center, University of Texas Southwestern Medical Center, Dallas, Texas
      sug:
        subj:
          Intraclass Correlation Coefficient
          Pain Drug Therapy
          Professional Practice, Evidence-Based
          Aged, 80 and Over
          Clinical Trials
          Data Analysis Software
          Descriptive Research
          Female
          Funding Source
          Hospitals
          Male
          Meperidine Administration and Dosage
          Midwestern United States
          Nurses
          Physicians
          Human
          Aged, 80 & over
          Female
          Male
      ab: Background: In health care and community-based intervention studies, cluster-randomised designs have been increasingly used because of administrative convenience, a desire to decrease treatment contamination, and the need to avoid ethical issues that might arise. While useful, cluster-randomised designs present challenges for data analysis. First, because of dependencies that exist among subjects within a cluster, methods that account for intra-class correlations have to be used. Second, on many occasions, because of unavailability of large numbers of clusters, lack of balance on baseline measures has to be carefully examined and appropriately controlled for. Aim/Methodology: Two strategies are presented that can be used when analysing data from a cluster-randomised design; both account for baseline differences. Examples of these challenges are provided by a pain management intervention study designed to promote the adoption of evidence-based pain management practices. One approach involves use of a mixed model via SAS PROC MIXED. The other approach involves use of a marginal model: Generalised estimating equations using SAS PROC GENMOD. Implications: In cluster-randomised design, one must adjust for intra-class correlation when evaluating the intervention effect. Although the parameter estimates and their standard errors might be comparable with both random effect and marginal strategies for certain link functions (identity link or log link only), the interpretations are quite different and the two approaches are suitable for indicating answers to different questions. If differences are present concerning baseline measures between experimental and control groups, accounting for baseline measures is important. The choice between a mixed model or marginal approach should be dictated by whether the primary interest is a population or individual.
      pubtype: Academic Journal
      doctype:
        clinical trial
        equations & formulas
        research
        Journal Article
      ougenre: Article
    language: English
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