Use of a randomized multiple baseline design: Rationale and design of the Spirited Life holistic health intervention study

Proeschold‐Bell, Rae Jean; Swift, Robin; Moore, H. Edgar; Bennett, Gary G.; Li, Xiangfang; Blouin, Rachel; Williams, Virginia P.; Williams, Redford B.; Toole, David

doi:10.1016/j.cct.2013.05.005

Cited by 16 publications

(18 citation statements)

References 82 publications

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“…The remainder used a variety of methods including generalised linear models (GLM) with robust variance estimators [ 46 – 48 ], Cox proportional hazards modelling [ 26 , 49 – 52 ], paired t-tests [ 53 , 54 ], χ 2 tests [ 54 , 55 ], McNemar’s test [ 56 ], Wilcoxon rank sum test/Mann-Whitney U test [ 57 , 58 ], Analysis of covariance (ANCOVA) [ 58 , 59 ], Analysis of variance (ANOVA) [ 60 ], Discourse mapping [ 61 ], GLM’s with cluster as a fixed effect [ 62 – 70 ] and GLM’s without any reported effort to adjust for clustering [ 71 – 75 ]. For some studies the method of analysis was unclear [ 14 , 76 – 79 ]. The potential confounding effect of time was explored in 61 of the 102 (60 %) studies and either adjusted for in the primary analysis or found not to be correlated with the outcome.…”

Section: Resultsmentioning

confidence: 99%

Stepped wedge cluster randomised trials: a review of the statistical methodology used and available

Barker

McElduff

DʼEste

et al. 2016

BMC Med Res Methodol

130

128

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BackgroundPrevious reviews have focussed on the rationale for employing the stepped wedge design (SWD), the areas of research to which the design has been applied and the general characteristics of the design. However these did not focus on the statistical methods nor addressed the appropriateness of sample size methods used.This was a review of the literature of the statistical methodology used in stepped wedge cluster randomised trials.MethodsLiterature Review. The Medline, Embase, PsycINFO, CINAHL and Cochrane databases were searched for methodological guides and RCTs which employed the stepped wedge design.ResultsThis review identified 102 trials which employed the stepped wedge design compared to 37 from the most recent review by Beard et al. 2015. Forty six trials were cohort designs and 45 % (n = 46) had fewer than 10 clusters. Of the 42 articles discussing the design methodology 10 covered analysis and seven covered sample size. For cohort stepped wedge designs there was only one paper considering analysis and one considering sample size methods. Most trials employed either a GEE or mixed model approach to analysis (n = 77) but only 22 trials (22 %) estimated sample size in a way which accounted for the stepped wedge design that was subsequently used.ConclusionsMany studies which employ the stepped wedge design have few clusters but use methods of analysis which may require more clusters for unbiased and efficient intervention effect estimates. There is the need for research on the minimum number of clusters required for both types of stepped wedge design. Researchers should distinguish in the sample size calculation between cohort and cross sectional stepped wedge designs. Further research is needed on the effect of adjusting for the potential confounding of time on the study power.

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Section: Resultsmentioning

confidence: 99%

Stepped wedge cluster randomised trials: a review of the statistical methodology used and available

Barker

McElduff

DʼEste

et al. 2016

BMC Med Res Methodol

130

128

View full text Add to dashboard Cite

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“…This study employed a staggered multiple baseline (pre-post) design to evaluate a pilot program integrating depression screening and treatment into routine HIV primary care using existing staff at two public health clinics in Lilongwe, Malawi [42]. Multiple baseline studies use a time-series design that can be used for studies with multiple sites in which each site intentionally receives the intervention at a different time point [42,43]. This design can also provide evidence of causal relationships where randomization is not possible and provides stronger control for temporal trends [42,43].…”

Section: Methodsmentioning

confidence: 99%

“…Multiple baseline studies use a time-series design that can be used for studies with multiple sites in which each site intentionally receives the intervention at a different time point [42,43]. This design can also provide evidence of causal relationships where randomization is not possible and provides stronger control for temporal trends [42,43]. As such, the program rolled out in two phases, a screening-only "control" phase and an active "intervention" phase.…”

Section: Methodsmentioning

confidence: 99%

The impact of an integrated depression and HIV treatment program on mental health and HIV care outcomes among people newly initiating antiretroviral therapy in Malawi

et al. 2020

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Background Depression is highly prevalent among patients newly starting antiretroviral treatment (ART) in Malawi and many other countries. Untreated depression at ART initiation can disrupt the HIV care continuum. Effective approaches for depression screening and treatment exist for low-resource settings, but they are rarely applied. Identifying effective implementation strategies are critical. Methods A pilot program integrated depression screening and treatment into routine HIV care using existing staff at two public health clinics in Malawi in two phases; a screening-only "control" phase and an active "intervention" phase. During the intervention phase, providers prescribed antidepressants or referred patients for Friendship Bench problem-solving therapy. We evaluated the program's impact on retention in HIV care, viral suppression, and depression remission at 6 months using tabular comparisons and log-binomial models to estimate adjusted risk ratios and mean differences among the intervention group relative to the control group. Results Nearly all consenting participants were screened for depression appropriately and 25% had mild to severe depressive symptoms. During the intervention phase, 86% of participants with mild depressive symptoms started Friendship Bench therapy and 96% of participants

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“…Pastors in this study and other studies (Meek et al, 2003) note the importance of family support in reducing their stress and helping them with work-life balance. Clergy health programs have recently begun to be developed (Proeschold-Bell et al, 2013; Wallace et al, 2012). However, only one program to-date has reported outcome evaluation data indicating that although a clergy health program improved markers of physical health (e.g., metabolic syndrome), it was not effective at improving self-reported stress or depression scores among clergy (Proeschold-Bell et al, 2017).…”

Section: Discussionmentioning

confidence: 99%

Leading God’s People: Perceptions of Influence Among African–American Pastors

et al. 2018

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Religious leaders, particularly African-American pastors, are believed to play a key role in addressing health disparities. Despite the role African-American pastors may play in improving health, there is limited research on pastoral influence. The purpose of this study was to examine African-American pastors' perceptions of their influence in their churches and communities. In-depth interviews were conducted with 30 African-American pastors and analyzed using a grounded theory approach. Three themes emerged: the historical role of the church; influence as contextual, with pastors using comparisons with other pastors to describe their ability to be influential; and a reciprocal relationship existing such that pastors are influenced by factors such as God and their community while these factors also aid them in influencing others. A conceptual model of pastoral influence was created using data from this study and others to highlight factors that influence pastors, potential outcomes and moderators as well as the reciprocal nature of pastoral influence.

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Use of a randomized multiple baseline design: Rationale and design of the Spirited Life holistic health intervention study

Cited by 16 publications

References 82 publications

Stepped wedge cluster randomised trials: a review of the statistical methodology used and available

Stepped wedge cluster randomised trials: a review of the statistical methodology used and available

The impact of an integrated depression and HIV treatment program on mental health and HIV care outcomes among people newly initiating antiretroviral therapy in Malawi

Leading God’s People: Perceptions of Influence Among African–American Pastors

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