scholarly journals Can patient decision aids reduce decisional conflict in a de-escalation of breast radiotherapy clinical trial? The PRIMETIME Study Within a Trial implemented using a cluster stepped-wedge trial design

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Indrani S. Bhattacharya ◽  
Joanne S. Haviland ◽  
Lesley Turner ◽  
Hilary Stobart ◽  
Ada Balasopoulou ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Patient Information ◽  
Trial Design ◽  
Decision Aids ◽  
Decisional Conflict ◽  
Stepped Wedge ◽  
Patient Decision ◽  
Study Within A Trial ◽  
Information Group ◽  
Stepped Wedge Trial

Abstract Background For patients with early breast cancer considered at very-low risk of local relapse, risks of radiotherapy may outweigh the benefits. Decisions regarding treatment omission can lead to patient uncertainty (decisional conflict), which may be lessened with patient decision aids (PDA). PRIMETIME (ISRCTN 41579286) is a UK-led biomarker-directed study evaluating omission of adjuvant radiotherapy in breast cancer; an embedded Study Within A Trial (SWAT) investigated whether PDA reduces decisional conflict using a cluster stepped-wedge trial design. Methods PDA diagrams and a video explaining risks and benefits of radiotherapy were developed in close collaboration between patient advocates and PRIMETIME trialists. The SWAT used a cluster stepped-wedge trial design, where each cluster represented the radiotherapy centre and referring peripheral centres. All clusters began in the standard information group (patient information and diagrams) and were randomised to cross-over to the enhanced information group (standard information plus video) at 2, 4 or 6 months. Primary endpoint was the decisional conflict scale (0–100, higher scores indicating greater conflict) which was assessed on an individual participant level. Multilevel mixed effects models used a random effect for cluster and a fixed effect for each step to adjust for calendar time and clustering. Robust standard errors were also adjusted for the clustering effect. Results Five hundred twenty-one evaluable questionnaires were returned from 809 eligible patients (64%) in 24 clusters between April 2018 and October 2019. Mean decisional conflict scores in the standard group (N = 184) were 10.88 (SD 11.82) and 8.99 (SD 11.82) in the enhanced group (N = 337), with no statistically significant difference [mean difference − 1.78, 95%CI − 3.82–0.25, p = 0.09]. Compliance with patient information and diagrams was high in both groups although in the enhanced group only 121/337 (36%) reported watching the video. Conclusion The low levels of decisional conflict in PRIMETIME are reassuring and may reflect the high-quality information provision, such that not everyone required the video. This reinforces the importance of working with patients as partners in clinical trials especially in the development of patient-centred information and decision aids.

scholarly journals A regional systems intervention for suicide prevention in the Netherlands (SUPREMOCOL): study protocol with a stepped wedge trial design

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
Emma Hofstra ◽  
Iman Elfeddali ◽  
Margot Metz ◽  
Marjan Bakker ◽  
Jacobus J. de Jong ◽  
...  
Keyword(s):  
Mental Health ◽  
Suicidal Ideation ◽  
The Netherlands ◽  
Suicide Prevention ◽  
Study Protocol ◽  
Collaborative Care ◽  
Trial Design ◽  
Stepped Wedge ◽  
Health Institutions ◽  
Stepped Wedge Trial

Abstract Background In the Netherlands, suicide rates showed a sharp incline and this pertains particularly to the province of Noord-Brabant, one of the southern provinces in the Netherlands. This calls for a regional suicide prevention effort. Methods/design Study protocol. A regional suicide prevention systems intervention is implemented and evaluated by a stepped wedge trial design in five specialist mental health institutions and their adherent chain partners. Our system intervention is called SUPREMOCOL, which stands for Suicide Prevention by Monitoring and Collaborative Care, and focuses on four pillars: 1) recognition of people at risk for suicide by the development and implementation of a monitoring system with decision aid, 2) swift access to specialist care of people at risk, 3) positioning nurse care managers for collaborative care case management, and 4) 12 months telephone follow up. Eligible patients are persons attempting suicide or expressing suicidal ideation. Primary outcome is number of completed suicides, as reported by Statistics Netherlands and regional Public Health Institutes. Secondary outcome is number of attempted suicides, as reported by the regional ambulance transport and police. Suicidal ideation of persons registered in the monitoring system will, be assessed by the PHQ-9 and SIDAS questionnaires at baseline and 3, 6, 9 and 12 months after registration, and used as exploratory process measure. The impact of the intervention will be evaluated by means of the RE-AIM dimensions reach, efficacy, adoption, implementation, and maintenance. Intervention integrity will be assessed and taken into account in the analysis. Discussion The present manuscript presents the design and development of the SUPREMOCOL study. The ultimate goal is to lower the completed suicides rate by 20%, compared to the control period and compared to other provinces in the Netherlands. Moreover, our goal is to provide specialist mental health institutions and chain partners with a sustainable and adoptable intervention for suicide prevention. Trial registration Netherlands Trial Register under registration number NL6935 (5 April 2018). This is the first version of the study protocol (September 2019).

Stepped-wedge trial design to evaluate Ebola treatments

2015 ◽  
Vol 15 (7) ◽  
pp. 762-763 ◽  
Author(s):  
Jolanta Piszczek ◽  
Eric Partlow
Keyword(s):  
Trial Design ◽  
Stepped Wedge ◽  
Stepped Wedge Trial

scholarly journals Clarifying Values: An Updated and Expanded Systematic Review and Meta-Analysis

2021 ◽  
Author(s):  
Holly O. Witteman ◽  
Ruth Ndjaboue ◽  
Gratianne Vaisson ◽  
Selma Chipenda Dansokho ◽  
Bob Arnold ◽  
...  
Keyword(s):  
Decision Analysis ◽  
Decision Aids ◽  
Decisional Conflict ◽  
Multicriteria Decision Analysis ◽  
Values Clarification ◽  
Patient Decision Aids ◽  
Multicriteria Decision ◽  
Patient Decision ◽  
Chi Squared ◽  
Decisional Regret

AbstractBackgroundPatient decision aids should help people make evidence-informed decisions aligned with their values. There is limited guidance about how to achieve such alignment.PurposeTo describe the range of values clarification methods available to patient decision aid developers, synthesize evidence regarding their relative merits, and foster collection of evidence by offering researchers a proposed set of outcomes to report when evaluating the effects of values clarification methods.Data SourcesMEDLINE, EMBASE, PubMed, Web of Science, the Cochrane Library, CINAHLStudy SelectionWe included articles that described randomized trials of one or more explicit values clarification methods. From 30,648 records screened, we identified 33 articles describing trials of 43 values clarification methods.Data ExtractionTwo independent reviewers extracted details about each values clarification method and its evaluation.Data SynthesisCompared to control conditions or to implicit values clarification methods, explicit values clarification methods decreased the frequency of values-disgruent choices (risk difference -0.04 95% CI [-0.06 to -0.02], p<.001) and decisional regret (standardized mean difference -0.20 95% CI [-0.29 to -0.11], p<0.001). Multicriteria decision analysis led to more values-congruent decisions than other values clarification methods (Chi-squared(2)=9.25, p=.01). There were no differences between different values clarification methods regarding decisional conflict (Chi-squared(2)=6.08, p=.05).LimitationsSome meta-analyses had high heterogeneity. We grouped values clarification methods into broad categories.ConclusionsCurrent evidence suggests patient decision aids should include an explicit values clarification method. Developers may wish to specifically consider multicriteria decision analysis. Future evaluations of values clarification methods should report their effects on decisional conflict, decisions made, values congruence, and decisional regret.

Development and evaluation of a consumer information resource, including Patient Decision Aid, for lung cancer screening: a quasi-experimental study

2019 ◽  
Vol 10 (2) ◽  
pp. 404-412 ◽  
Author(s):  
David Manners ◽  
Simone Pettigrew ◽  
Fiona R Lake ◽  
Francesco Piccolo ◽  
Annette M McWilliams ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Cancer Screening ◽  
Decision Aids ◽  
Lung Cancer Screening ◽  
Lung Cancer Mortality ◽  
Decisional Conflict ◽  
Consumer Information ◽  
Post Exposure ◽  
Patient Decision ◽  
Quasi Experimental

Abstract Lung cancer screening of high-risk individuals with computed tomography is a promising intervention to reduce lung cancer mortality. Patient Decision Aids (PtDAs) may assist eligible individuals assess the risks and benefits associated with screening. Screening preference is high among lower-risk, screening-ineligible individuals and strategies are needed to reduce screening demand among this group. We developed and evaluated a resource comprising a recruitment pamphlet combined with either a PtDA for screening-eligible individuals or an education pamphlet for screening-ineligible individuals. Quasi-experimental pre-post pamphlet exposure design. Ever-smokers aged 55–80 years attending hospital outpatient clinics were invited. Among screening-eligible participants, the assessed outcome was change in score on the Decisional Conflict Scale (DCS). Among screening-ineligible participants, the assessed outcomes were change in screening preference. In the study 51% (55/107) of invited individuals participated, with mean ± standard deviation age 66.9 ± 6.4 years, 53% (29/55) male, and 65% (36/55) eligible for screening. Median (interquartile range) DCS among screening-eligible participants reduced from 28.9 (22.7–45.3) pre-PtDA to 25 (1.6–29.7) post-PtDA (p &lt; .001), but there was no significant change in the proportion that reached the accepted threshold for decisional certainty (DCS &lt; 25, 10/36 [28%] pre-exposure vs. 14/36 [39%] post-exposure, p = .1). Screening preference among screening-ineligible individuals reduced after viewing the screening-ineligible brochure (pre-exposure median of “Prefer” to post-exposure median of “Unsure,” p = .001). Our consumer information pamphlets about lung cancer screening may reduce decisional conflict and improve alignment of screening preference with eligibility.

scholarly journals swCRTdesign: An RPackage for Stepped Wedge Trial Design and Analysis

2020 ◽  
Vol 196 ◽  
pp. 105514
Author(s):  
Emily C. Voldal ◽  
Navneet R. Hakhu ◽  
Fan Xia ◽  
Patrick J. Heagerty ◽  
James P. Hughes
Keyword(s):  
Trial Design ◽  
Stepped Wedge ◽  
Stepped Wedge Trial

scholarly journals Go to the Hospital or Stay Here?: A Randomized Clinical Trial

2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 760-760
Author(s):  
Sarah Worch ◽  
Ruth Tappen
Keyword(s):  
Clinical Trial ◽  
Decision Aid ◽  
Long Term Care ◽  
Decision Aids ◽  
Decisional Conflict ◽  
Term Care ◽  
Patient Decision Aids ◽  
Patient Decision ◽  
Initial Clinical Trial

Abstract With the exception of guides for making end of life choices, there are very few if any patient decision aids created for residents of long-term care facilities. Further, only half of patient decision aids produced for any purpose have actually been field tested with patients and even fewer have been evaluated by providers other than the developers of the decision aid. Development of Go to the Hospital or Stay Here? was based on expert experience combined with extensive input from over 270 long-term care residents, their families and their caregivers. The initial clinical trial of this decision aid is reported in this presentation. Increased knowledge, reduced decisional conflict, increased preference for care in the nursing home when possible and a high rating of the helpfulness of the Guide were found in those who received the Guide (n=97) compared to those who did not (n=95).

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