The adapted Zelen was a feasible design to trial exercise in myeloma survivors

Abstract

Objectives We used a method rarely seen in cancer behavioral trials to explore methods of overcoming difficulties often seen in randomized controlled trials. We report our experiences of the adapted Zelen design, so that other researchers can consider this approach for behavioral trials. Study Design and Setting The adapted Zelen design was used to explore the effects of exercise on multiple myeloma patients fatigue, quality of life, and physical outcomes. All participants consented to an observational cohort study of lifestyle factors but were unaware of subsequent randomization to remain in cohort only group or be offered an exercise intervention requiring second consent. Results There was lower than expected uptake to the exercise offered group (57%), so the length of recruitment increased from 24 to 29 months to ensure power was reached. At enrollment, patients were unaware of the potential increased commitment, and as a result, 62% of participants allocated to the intervention declined because of the extra time/travel commitment required. This emulates clinical settings and suggests improvements in intervention delivery are required. Our findings suggest that the adapted Zelen design may be useful in limiting dropout of controls due to dissatisfaction from group allocation, or contamination of control arm. Conclusion Future use of this design warrants careful consideration of the study resources and recruitment time frames required but holds potential value in reducing contamination, control group dissatisfaction, and resulting dropout. Adapted Zelen design reduces selection bias and therefore gives clinicians a better understanding of acceptability in clinical settings. Future studies should evaluate control group experiences of the design and formally record contamination throughout the study to confirm its acceptability.

The effect of exercise and nutrition interventions on physical functioning in patients undergoing haematopoietic stem cell transplantation: a systematic review and meta-analysis

“…3. Randomization, concealment and the occurrence of baseline differences were adequately described and free of risk of bias in six studies [34,35,[37][38][39][40][41][42][43][44]46]. Three studies were at high risk of bias due to deviations from the intervention [45,46,49].…”

“…In five studies, (some) outcome assessors were clearly blinded [37-39, 41-45, 49]. The selection of the reported results was often not described; only two studies published a protocol describing the analysis plan [38,39,[41][42][43][44]. Two studies used multiple eligible analyses of the data that resulted in a high risk of bias [29-32, 34, 35].…”

“…Four studies reported a variety of outcome measurements accumulated by body composition measurement [37][38][39][40]46]. The effect on body fat was not significant (SMD 0.01, 95% CI − 0.30 to 0.31, Supplementary Fig.…”

“…2A). Weight was assessed by three studies [34,35,[37][38][39]. It decreased in the exercise group compared to the usual care group, but this effect was not significant (MD − 2.45 kg, 95% CI − 6.48 to1.59, Supplementary Fig.…”

E-health psychological intervention in pregnant women exposed to intimate partner violence (eIPV): A protocol for a pilot randomised controlled trial

“…To write the present protocol, the SPIRIT guidelines were followed (S1 and S2 Checklists). We will use a modified Zelen' design with a double consent process [22][23][24] and a delayed intervention for the control group. In the first stage, informed consent will be sought from all pregnant women to enter a cohort study.…”