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[PDF] Top 20 Sample size calculation for a stepped wedge trial

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Sample size calculation for a stepped wedge trial

Sample size calculation for a stepped wedge trial

... In our study, the stepped wedge design was found to be relatively insensitive to variations in the ICC, a find- ing reported previously in [14]. We also found that in the case where measurements are taken ... See full document

15

HELP! Problems in executing a pragmatic, randomized, stepped wedge trial on the Hospital Elder Life Program to prevent delirium in older patients

HELP! Problems in executing a pragmatic, randomized, stepped wedge trial on the Hospital Elder Life Program to prevent delirium in older patients

... priori sample size needed was 940 patients equally distributed over the control group “pre-HELP” and the intervention group “the HELP condition” (see design paper [11] for the full sample size ... See full document

12

Protocol for a phase III pragmatic stepped wedge cluster randomised controlled trial comparing the effectiveness and cost effectiveness of screening and guidelines with, versus without, implementation strategies for improving pain in adults with cancer at

Protocol for a phase III pragmatic stepped wedge cluster randomised controlled trial comparing the effectiveness and cost effectiveness of screening and guidelines with, versus without, implementation strategies for improving pain in adults with cancer attending outpatient oncology and palliative care services: the Stop Cancer PAIN trial

... To assess the appropriate study sample size and compute study power, we used a computer simulation allowing for 20% dropout by both services and patients. Drawing on data from 1612 consecutive patients ... See full document

13

Improving the implementation of perioperative safety guidelines using a multifaceted intervention approach: protocol of the IMPROVE study, a stepped wedge cluster randomized trial

Improving the implementation of perioperative safety guidelines using a multifaceted intervention approach: protocol of the IMPROVE study, a stepped wedge cluster randomized trial

... This study comprises nine hospitals in the Netherlands: two academic, four tertiary teaching, and three regional hospitals, with 200 to up to more than 1,300 beds each. Eight hospitals have a NIAZ accreditation. This ... See full document

11

PARROT Ireland: Placental growth factor in Assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial Research Study Protocol

PARROT Ireland: Placental growth factor in Assessment of women with suspected pre-eclampsia to reduce maternal morbidity: a Stepped Wedge Cluster Randomised Control Trial Research Study Protocol

... To provide protection for study participants an inde- pendent data monitoring committee (DMC) has been appointed for this trial. The DMC comprises four members who are not involved with any other aspect of the ... See full document

14

Effectiveness and cost effectiveness of routine third trimester ultrasound screening for intrauterine growth restriction: study protocol of a nationwide stepped wedge cluster randomized trial in The Netherlands (The IRIS Study)

Effectiveness and cost effectiveness of routine third trimester ultrasound screening for intrauterine growth restriction: study protocol of a nationwide stepped wedge cluster randomized trial in The Netherlands (The IRIS Study)

... our trial is its large sample ...current trial is adequately powered to exam- ine whether third trimester ultrasound screening can reduce severe adverse perinatal ...our trial examines the ... See full document

11

A systematic review of randomised controlled trials in rheumatoid arthritis: the reporting and handling of missing data in composite outcomes

A systematic review of randomised controlled trials in rheumatoid arthritis: the reporting and handling of missing data in composite outcomes

... outcomes, trial design; sample size calcula- tion and whether this calculation included a dropout rate; amount of missing information (proportion of missing out- come data in each treatment ... See full document

8

Early and comprehensive care bundle in the elderly for acute heart failure in the emergency department: study protocol of the ELISABETH stepped wedge cluster randomized trial

Early and comprehensive care bundle in the elderly for acute heart failure in the emergency department: study protocol of the ELISABETH stepped wedge cluster randomized trial

... small sample of patients (less than 200 in total) [13, ...prospective trial on AHF management failed to report a clinically significant improvement of ... See full document

8

Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow 1 trial): study protocol for a pragmatic, stepped wedge, cluster randomized controlled registry

Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow 1 trial): study protocol for a pragmatic, stepped wedge, cluster randomized controlled registry

... Our sample size of six clusters (10,500 patients in total) achieves 80% power to detect a 10% absolute difference assuming a control pro- portion of ...Our calculation assumes an intracluster ... See full document

13

The PULSAR primary care protocol: a stepped wedge cluster randomized controlled trial to test a training intervention for general practitioners in recovery oriented practice to optimize personal recovery in adult patients

The PULSAR primary care protocol: a stepped wedge cluster randomized controlled trial to test a training intervention for general practitioners in recovery oriented practice to optimize personal recovery in adult patients

... is often missing from randomized controlled trials; how- ever, the UK Medical Research Council has provided use- ful guidelines for bringing rigor to the conduct of such evaluations. The value of process evaluation ... See full document

16

Sample size calculation in multi-centre clinical trials

Sample size calculation in multi-centre clinical trials

... tive sample size reestimation procedure could account for this problem as it has been applied for cluster ran- domized trials and the fixed effects multi-centre trial design ...of sample ... See full document

10

The Devon Active Villages Evaluation (DAVE) trial: Study protocol of a stepped wedge cluster randomised trial of a community level physical activity intervention in rural southwest England

The Devon Active Villages Evaluation (DAVE) trial: Study protocol of a stepped wedge cluster randomised trial of a community level physical activity intervention in rural southwest England

... true size of the differ- ence between intervention and control participants re- garding metabolic equivalent minutes per week (adjusted mean difference: 171; 95% CI: -16 to 358; p = ...between trial modes, ... See full document

12

Proceedings of the First International Conference on Stepped Wedge Trial Design

Proceedings of the First International Conference on Stepped Wedge Trial Design

... A stepped wedge (SW) design, comparing standard treatment (A) with a new treatment (B), can be thought of as allocating units to L sequences of treatments, with each sequence divided into T succes- sive ... See full document

6

Impact of early initiation versus national standard of care of antiretroviral therapy in Swaziland’s public sector health system: study protocol for a stepped wedge randomized trial

Impact of early initiation versus national standard of care of antiretroviral therapy in Swaziland’s public sector health system: study protocol for a stepped wedge randomized trial

... random sample of patients tested HIV-positive during the control phase and during the intervention phase at six and 12 months (T1, T2, T3, n = 380 per survey, 760 in ...random sample of HIV- positive ... See full document

10

Designing a stepped wedge trial: three main designs, carry over effects and randomisation approaches

Designing a stepped wedge trial: three main designs, carry over effects and randomisation approaches

... the trial could be designed with the maximum number of steps, and step length set simply with the total trial duration and hence sample size in ...the trial in one school year, and step ... See full document

12

Tight or less tight glycaemic targets for women with gestational diabetes mellitus for reducing maternal and perinatal morbidity? (TARGET): study protocol for a stepped wedge randomised trial

Tight or less tight glycaemic targets for women with gestational diabetes mellitus for reducing maternal and perinatal morbidity? (TARGET): study protocol for a stepped wedge randomised trial

... a stepped wedge, cluster randomised trial the 10 participating hospitals will be randomised to the timing of the change from the less tight to the tighter glycaemic target ...A sample ... See full document

6

Institutionalizing postpartum intrauterine device (IUD) services in Sri Lanka, Tanzania, and Nepal: study protocol for a cluster randomized stepped wedge trial

Institutionalizing postpartum intrauterine device (IUD) services in Sri Lanka, Tanzania, and Nepal: study protocol for a cluster randomized stepped wedge trial

... 55% sample of women enrolled at baseline who live within 24 h of the study hospital will be randomly selected to complete the two long-term follow up interviews at 9 months and 18 months ... See full document

11

An imbalance in cluster sizes does not lead to notable loss of power in cross sectional, stepped wedge cluster randomised trials with a continuous outcome

An imbalance in cluster sizes does not lead to notable loss of power in cross sectional, stepped wedge cluster randomised trials with a continuous outcome

... for sample size calculation then need to be developed to ensure that these SW-CRTs are appropriately powered, especially those using a cohort rather than cross-sectional ...the sample ... See full document

11

Stepped wedge cluster randomized controlled trial designs: a review of reporting quality and design features

Stepped wedge cluster randomized controlled trial designs: a review of reporting quality and design features

... on trial reports published from 2010 to ...to sample size ...to sample size calculation or trial analysis, remains an important step to be ... See full document

13

Promoting Recruitment using Information Management Efficiently (PRIME): statistical analysis plan for a stepped wedge cluster randomised trial within the REstart or STop Antithrombotics Randomised Trial (RESTART)

Promoting Recruitment using Information Management Efficiently (PRIME): statistical analysis plan for a stepped wedge cluster randomised trial within the REstart or STop Antithrombotics Randomised Trial (RESTART)

... closed-cohort, stepped wedge design whereby all participating sites are included from the start through to the end of the trial, and we are in- terested in assessing the recruitment rate within fixed ... See full document

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