Cluster Randomised Trials: Sources of Bias. Ada Keding Professor David Torgerson

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1 Cluster Randomised Trials: Sources of Bias Ada Keding Professor David Torgerson

2 Problems with Cluster Randomisation Possible Selection Bias; Inadequate uptake of intervention by either group reduces study power; Sample size needs to be increased (typically between 50% to 100%), which will often increase the cost and complexity of a trial.

3 Selection Bias in Randomised Trials This should not occur in an individually randomised trial unless the randomisation has been subverted. However, in cluster trials it is possible for selection bias to occur after successful cluster randomisation. This defeats the objective of randomisation.

4 Selection Bias in Cluster Trials Randomisation abolishes selection bias in a cluster trial ONLY if all eligible cluster members, or a random sample, within the cluster are included in the trial.

5 Recruitment into cluster trials A key issue is individual participant recruitment into cluster trials. There are a number of ways where biased participant recruitment can occur, which can lead to baseline imbalances in important prognostic factors.

6 UK BEAM Trial The UKBEAM pilot study used a cluster design. Eligible patients were identified by GPs for trial inclusion. GP practices were randomised to usual care or extra training. The primary care team were trained to deliver active management of backpain.

7 UK BEAM Selection bias The pilot showed that practices allocated to active management were more adept at identifying patients with low back pain and including them in the trial. Patients had different characteristics in one arm than the other.

8 UK BEAM participant recruitment 26 Practices Type title here 13 Active Management 102,063 registered patients 13 Usual Care 106,834 registered patients 165 Recruited Participants 66 Recruited Participants Roland = 8.9 Aberdeen = 28.6 SF36 = 61.8 P = P = P = 0.03 Roland = 10.3 Aberdeen = 34.2 SF36 = 55.2

9 UKBEAM pilot study. Recruitment by Practice Status Number of participants Apr 98 May 98 Jun 98 Jul 98 Aug 98 Sep 98 Oct 98 Nov 98 Dec 98 Jan 99 Feb 99 Mar 99 Apr 99

10 Another musculoskeletal trial SAPPHIRE trial of guidelines educating GPs on identification and management of shoulder pain Very similar design to UKBEAM At first TMC evidence of recruitment bias occurring independent members of TSC recommended continuation of trial

11 Num bers recruited 120 Cumulative actual - untrained 100 Cumulative actual - trained Fe b Ma r Apr il Ma y Jun e Jul y Cumulative actual - untrained Cumulative actual - trained Au g Se pt Oct No v De c Jan Fe b Ma r Apr il Ma y Jun e Jul y Month of recruitment

12 Review of Cluster Trials Because of the BEAM problem York Trials Unit decided to undertake a methodological review of cluster trials. They identified all cluster trials published in the BMJ, Lancet, NEJM since Puffer et al. BMJ 2003;327:785.

13 Results We identified 36 relevant trials. ONLY 13 had identified participants prior to randomisation. Of the 23 not identifying participants a priori 7 showed evidence of differential recruitment or consent. Other biases included differential of inclusion criteria or attrition. In total 14 (39%) showed evidence of bias.

14 Misleading trial One trial (Jorhdoy, Lancet 2000) where there was no evidence of biased recruitment was later found to have suffered recruitment bias in another publication. This was an RCT for home care for terminally ill patients. There was, no evidence, in the Lancet paper of a problem. BUT

15 Baseline Characteristics Intervention Control Live in Flat 40% 23% P < Married 67% 59% P = 0.07 Access to help P values adjusted for clustering. 80% 70% P = 0.04 Jordhoy Palliative Medicine :43-49.

16 2008 cluster trials Study Were patients identified prior to randomisation? Identification prior to randomisation possible? Althabe w1 No No Not likely Baqui w2 No No Not likely Bellary w3 Yes Yes Not possible Campbell w4 No Yes - Possible Cheyne w5 No Yes Possible Is recruitment bias likely? Clarke w6 No Yes - Possible Cumming w7 No No Not likely Davies w8 No No Possible Doig w9 No No Not likely Hiscock w10 Yes Yes Not possible Jewkes w11 No Yes Possible Jeyaratnam w12 No No Possible Kerse w13 Yes Yes Not possible Kumar w14 Unclear No Unclear Melese w15 Yes Yes Not possible Moet w16 Yes Yes Not possible Pasanen w17 Yes Yes Not possible Rahman w18 No No Not likely Ruel w19 No Yes Not likely Soligard w20 Yes Yes Not possible SUMMIT w21 Yes Yes Not possible Tol w22 No Yes. Possible Wood w23 No Yes Possible Zeng w24 Yes Yes Not possible

17 Summary of 2008 trials Of the 24 trials, eight could have used individual randomisation as an alternative to cluster allocation. Seven studies could have recruited participants prior to cluster randomisation but did not. In 8 studies where recruitment bias was possible more than half (5) demonstrated some evidence of differential recruitment rates. Brierley et al, 2012 J Eval in Clin Prac 18:878.

18 Fig 1 Trial profile of clusters, all women and women with six week EPDS score >=12 in control and intervention groups. Note: 597 women were not sent 12 month questionnaire as their baby was <12 months, and 1879 women were not sent 18 month questionnaire as their baby was not 18 months when follow-up interval ended Note: 35 per cluster for control group and 44 per cluster for intervention 26% difference Copyright 2009 BMJ Publishing Group Ltd. Morrell, C J. et al. BMJ 2009;338:a3045

19 Continuing evidence of a problem In 2018 is there still a problem with cluster randomised trials? Let s look at the latest research on this from Dept of Health Sciences at York.

20 Meta-analysis of age for individually randomised trials Difference = (95% CI to 0.035) I 2 = 0%

21 Meta-analysis of cluster trials of age Difference in age: (95% CI to ) I 2 = 93.2% Bolzern et al 2018 J Clin Epi in press

22 Hip Protector Trial 1725 eligible participants 8 Clusters 15 Clusters 650 in hip protector group 1075 in control group At this point trial is balanced for all co-variates Kannus. N Eng J Med 2000;343:1506.

23 Hip Protector Trial 1725 eligible participants 8 Clusters 15 Clusters 650 in hip protector group 1075 in control group 204 refused (31%) 94 refused (9%) 446 At baseline 69% 981 At baseline 91% Selection Bias

24

25 Figure 2 The Lancet , DOI: ( /S (16) ) Copyright 2016 Elsevier Ltd Terms and Conditions

26 Figure 1 The Lancet , DOI: ( /S (16) ) Copyright 2016 Elsevier Ltd Terms and Conditions

27

28 Summary Cluster trials are open to bias and too many researchers do not design them sufficiently well to avoid their vulnerability to selection bias. Stepped wedge studies will probably be more at risk than normal cluster trials as it may be more difficult to recruit before randomisation.

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