Sample size determinations for group-based randomized clinical trials with different levels of data hierarchy between experimental and control arms

Statistical Methods in Medical Research

Volumn 26, Issue 1, 2017, Pages 399-413

  Heo, Moonseong ^a   Litwin, Alain H ^a   Blackstock, Oni ^a   Kim, Namhee ^a   Arnsten, Julia H ^a  

^a ALBERT EINSTEIN COLLEGE OF MEDICINE   (United States)

Author keywords

group based intervention; mixed effects model; multi level data; sample size; varying sizes

Indexed keywords

ARTICLE; CLUSTER ANALYSIS; DIABETES MELLITUS; HEALTH CARE POLICY; HEALTH CARE SYSTEM; HUMAN; RANDOMIZED CONTROLLED TRIAL (TOPIC); SAMPLE SIZE; SIMULATION; STANDARDIZATION; STATISTICAL DISTRIBUTION; STATISTICAL MODEL; PROCEDURES; REPRODUCIBILITY;

HUMANS; LINEAR MODELS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS; SAMPLE SIZE;

EID: 85008657262     PISSN: 09622802     EISSN: 14770334     Source Type: Journal    
DOI: 10.1177/0962280214547381     Document Type: Article

References (22)

1. Jaber R, Braksmajer A, Trilling JS,. Group visits: A qualitative review of current research. J Am Board Family Med 2006; 19: 276-290.
2. Drum D, Becker M, Hess E,. Expanding the application of group interventions: emergence of groups in health care settings. J Specialist Group Work 2011; 36: 247-263.
3. McCarthy C, Hart S,. Designing groups to meet evolving challenges in health care settings. J Specialist Group Work 2011; 36: 352-367.
4. Wagner EH, Grothaus LC, Sandhu N, et al. Chronic care clinics for diabetes in primary care-A system-wide randomized trial. Diab Care 2001; 24: 695-700.
5. Sadur CN, Moline N, Costa M, et al. Diabetes management in a health maintenance organization-Efficacy of care management using cluster visits. Diabetes Care 1999; 22: 2011-2017.
6. Burke RE, O'Grady ET,. Group visits hold great potential for improving diabetes care and outcomes, but best practices must be developed. Health Affairs 2012; 31: 103-109.
7. Stein MR, Soloway IJ, Jefferson KS, et al. Concurrent group treatment for hepatitis C: Implementation and outcomes in a methadone maintenance treatment program. J Substance Abuse Treatment 2012; 43: 424-432.
8. Moadel AB, Bernstein SL, Mermelstein RJ, et al. A randomized controlled trial of a tailored group smoking cessation intervention for HIV-infected smokers. JAIDS 2012; 61: 208-215.
9. Ickovics JR, Kershaw TS, Westdahl C, et al. Group prenatal care and perinatal outcomes: A Randomized controlled trial. Obstet Gynecol 2007; 110: 937-937.
10. Scott JC, Conner DA, Venohr I, et al. Effectiveness of a group outpatient visit model for chronically ill older health maintenance organization members: A 2-year randomized trial of the cooperative health care clinic. J Am Geriatrics Soc 2004; 52: 1463-1470.
11. Freitag CM, Cholemkery H, Elsuni L, et al. The group-based social skills training SOSTA-FRA in children and adolescents with high functioning autism spectrum disorder-study protocol of the randomised, multi-centre controlled SOSTA-net trial. Trials 2013; 14: 12-12.
12. Barlow J, Smailagic N, Huband N, et al. Group-based parent training programmes for improving parental psychosocial health. Cochrane Database Systematic Rev 2012, pp. 200-200.
13. Roberts C, Roberts SA,. Design and analysis of clinical trials with clustering effects due to treatment. Clin Trials 2005; 2: 152-162.
14. Bauer DJ, Sterba SK, Hallfors DD,. Evaluating group-based interventions when control participants are ungrouped. Multivariate Behavior Res 2008; 43: 210-236.
15. Baldwin SA, Bauer DJ, Stice E, et al. Evaluating models for partially clustered designs. Psychol Meth 2011; 16: 149-165.
16. Moerbeek M, Wong WK,. Sample size formulae for trials comparing group and individual treatments in a multilevel model. Stat Med 2008; 27: 2850-2864.
17. Cohen J,. Statistical power analysis for the behavioral science, Hillsdale, NJ: Lawrence Erlbaum Associates, 1988.
18. Kenward MG, Roger JH,. Small sample inference for fixed effects from restricted maximum likelihood. Biometrics 1997; 53: 983-997.
19. Diggle PJ, Heagerty P, Linag K-Y, et al. Analysis of longitudinal data, 2nd ed. New York: Oxford University Press, 2002.
20. Heo M, Leon AC,. Statistical power and sample size requirements for three level hierarchical cluster randomized trials. Biometrics 2008; 64: 1256-1262.
21. Teerenstra S, Moerbeek M, van Achterberg T, et al. Sample size calculations for 3-level cluster randomized trials. Clinical Trials 2008; 5: 486-495.
22. Davis K, Abrams M, Stremikis K,. How the affordable care act will strengthen the nation's primary care foundation. J Gen Intern Med 2011; 26: 1201-1203.