scholarly journals Realist randomised controlled trials: A new approach to evaluating complex public health interventions

2012 ◽  
Vol 75 (12) ◽  
pp. 2299-2306 ◽  
Author(s):  
Chris Bonell ◽  
Adam Fletcher ◽  
Matthew Morton ◽  
Theo Lorenc ◽  
Laurence Moore
Keyword(s):  
Public Health ◽  
Randomised Controlled Trials ◽  
Health Interventions ◽  
Controlled Trials ◽  
Public Health Interventions ◽  
New Approach ◽  
Randomised Controlled

scholarly journals Beyond Interviews and Focus Groups: Mapping New Ways to Integrate Innovative Qualitative Methods into Randomised Controlled Trials of Complex Public Health Interventions

2018 ◽  
Author(s):  
Katherine Davis ◽  
Nicole Minckas ◽  
Virginia Bond ◽  
Cari Jo Clark ◽  
Tim Colbourn ◽  
...  
Keyword(s):  
Public Health ◽  
Qualitative Methods ◽  
Randomised Controlled Trials ◽  
Consort Statement ◽  
Ease Of Use ◽  
Health Interventions ◽  
Controlled Trials ◽  
Public Health Interventions ◽  
Effective Interventions ◽  
Randomised Controlled

Abstract Background: Randomised controlled trials (RCTs) are widely used for establishing evidence of the effectiveness of interventions, yet public health interventions are often complex, posing specific challenges for RCTs. While there is increasing recognition that qualitative methods can and should be integrated into RCTs, few frameworks and practical guidance highlight which qualitative methods should be integrated and for what purposes. As a result, qualitative methods are often poorly or haphazardly integrated into existing trials and researchers rely heavily on standard interviews and focus group discussions. To improve current practice, we propose a framework for innovative qualitative research methods that can help address the challenges of RCTs for complex public health interventions. Methods: We used a stepped approach to develop a practical framework for researchers, which included: (1) a systematic review of the innovative qualitative methods mentioned in the health literature, (2) in-depth interviews with 23 academics from different methodological backgrounds working on RCTs of public health interventions in 11 different countries, and (3) framework development and group consensus-building process. Results: The findings are presented according to the CONSORT Statement categories for ease of use. The main challenges of RCTs for public health interventions are identified alongside each of the CONSORT categories and potential innovative qualitative methods that overcome each challenge are listed as part of a Framework for the Integration of Innovative Qualitative Methods into RCTs of Complex Health Interventions. Innovative qualitative methods raised in the interviews and discussed in detail include: rapid ethnographic appraisals, document analysis, diary methods, interactive voice responses and SMS, community mapping, spiral walks, public randomisation, pair interviews, visual participatory analysis, among others. Conclusions: The findings of this study point to the usefulness of observational and participatory methods for trials of complex public health interventions, offering a novel contribution to the broader literature about the need for mixed methods approaches. Integrating a diverse toolkit of qualitative methods can enable appropriate adjustments during RCTs, which in turn create more sustainable and effective interventions. However, this will require a cultural shift including the adoption of method-neutral research approaches, transdisciplinary collaborations, and a shift in publishing regimes.

scholarly journals Beyond interviews and focus groups: a framework for integrating innovative qualitative methods into randomised controlled trials of complex public health interventions

2019 ◽  
Author(s):  
Katy Davis ◽  
Nicole Minckas ◽  
Virginia Bond ◽  
Cari Jo Clark ◽  
Tim Colbourn ◽  
...  
Keyword(s):  
Public Health ◽  
Qualitative Methods ◽  
Randomised Controlled Trials ◽  
Consort Statement ◽  
Ease Of Use ◽  
Health Interventions ◽  
Controlled Trials ◽  
Public Health Interventions ◽  
Effective Interventions ◽  
Randomised Controlled

Abstract Background: Randomised controlled trials (RCTs) are widely used for establishing evidence of the effectiveness of interventions, yet public health interventions are often complex, posing specific challenges for RCTs. While there is increasing recognition that qualitative methods can and should be integrated into RCTs, few frameworks and practical guidance highlight which qualitative methods should be integrated and for what purposes. As a result, qualitative methods are often poorly or haphazardly integrated into existing trials, and researchers rely heavily on interviews and focus group discussions. To improve current practice, we propose a framework for innovative qualitative research methods that can help address the challenges of RCTs for complex public health interventions. Methods: We used a stepped approach to develop a practical framework for researchers. This included: (1) a systematic review of the innovative qualitative methods mentioned in the health literature; (2) in-depth interviews with 23 academics from different methodological backgrounds working on RCTs of public health interventions in 11 different countries; and (3) a framework development and group consensus-building process. Results: The findings are presented according to the CONSORT Statement categories for ease of use. We identify the main challenges of RCTs for public health interventions alongside each of the CONSORT categories and potential innovative qualitative methods that overcome each challenge are listed as part of a Framework for the Integration of Innovative Qualitative Methods into RCTs of Complex Health Interventions. Innovative qualitative methods described in the interviews include: rapid ethnographic appraisals, document analysis, diary methods, interactive voice responses and SMS, community mapping, spiral walks, pair interviews and visual participatory analysis. Conclusions: The findings of this study point to the usefulness of observational and participatory methods for trials of complex public health interventions, offering a novel contribution to the broader literature about the need for mixed methods approaches. Integrating a diverse toolkit of qualitative methods can enable appropriate adjustments to the intervention and/ or process of data collection during RCTs, which in turn can create more sustainable and effective interventions. However, such integration will require a cultural shift towards the adoption of method-neutral research approaches, transdisciplinary collaborations, and publishing regimes.

scholarly journals Beyond interviews and focus groups: a framework for integrating innovative qualitative methods into randomised controlled trials of complex public health interventions

2019 ◽  
Author(s):  
Katy Davis ◽  
Nicole Minckas ◽  
Virginia Bond ◽  
Cari Jo Clark ◽  
Tim Colbourn ◽  
...  
Keyword(s):  
Public Health ◽  
Qualitative Methods ◽  
Randomised Controlled Trials ◽  
Consort Statement ◽  
Ease Of Use ◽  
Health Interventions ◽  
Controlled Trials ◽  
Public Health Interventions ◽  
Effective Interventions ◽  
Randomised Controlled

Abstract Background: Randomised controlled trials (RCTs) are widely used for establishing evidence of the effectiveness of interventions, yet public health interventions are often complex, posing specific challenges for RCTs. While there is increasing recognition that qualitative methods can and should be integrated into RCTs, few frameworks and practical guidance highlight which qualitative methods should be integrated and for what purposes. As a result, qualitative methods are often poorly or haphazardly integrated into existing trials, and researchers rely heavily on interviews and focus group discussions. To improve current practice, we propose a framework for innovative qualitative research methods that can help address the challenges of RCTs for complex public health interventions. Methods: We used a stepped approach to develop a practical framework for researchers. This included: (1) a systematic review of the innovative qualitative methods mentioned in the health literature; (2) in-depth interviews with 23 academics from different methodological backgrounds working on RCTs of public health interventions in 11 different countries; and (3) a framework development and group consensus-building process. Results: The findings are presented according to the CONSORT Statement categories for ease of use. We identify the main challenges of RCTs for public health interventions alongside each of the CONSORT categories and potential innovative qualitative methods that overcome each challenge are listed as part of a Framework for the Integration of Innovative Qualitative Methods into RCTs of Complex Health Interventions. Innovative qualitative methods described in the interviews include: rapid ethnographic appraisals, document analysis, diary methods, interactive voice responses and SMS, community mapping, spiral walks, pair interviews and visual participatory analysis. Conclusions: The findings of this study point to the usefulness of observational and participatory methods for trials of complex public health interventions, offering a novel contribution to the broader literature about the need for mixed methods approaches. Integrating a diverse toolkit of qualitative methods can enable appropriate adjustments to the intervention and/ or process of data collection during RCTs, which in turn can create more sustainable and effective interventions. However, such integration will require a cultural shift towards the adoption of method-neutral research approaches, transdisciplinary collaborations, and publishing regimes.

scholarly journals The Effect of Perioperative E-Health Interventions on the Postoperative Course: A Systematic Review of Randomised and Non-Randomised Controlled Trials

PLoS ONE ◽  
2016 ◽  
Vol 11 (7) ◽  
pp. e0158612 ◽  
Author(s):  
Eva van der Meij ◽  
Johannes R. Anema ◽  
René H. J. Otten ◽  
Judith A. F. Huirne ◽  
Frederieke G. Schaafsma
Keyword(s):  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Health Interventions ◽  
Controlled Trials ◽  
Postoperative Course ◽  
Randomised Controlled

scholarly journals Effects of COVID-19 Mental Health Interventions among Community-based Children, Adolescents, and Adults: A Living Systematic Review of Randomised Controlled Trials

2021 ◽  
Author(s):  
Olivia Bonardi ◽  
Yutong Wang ◽  
Kexin Li ◽  
Xiaowen Jiang ◽  
Ankur Krishnan ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trials ◽  
Risk Of Bias ◽  
Health Interventions ◽  
Controlled Trials ◽  
Post Intervention ◽  
Community Based ◽  
Adolescents And Adults ◽  
Mental Health Interventions ◽  
Randomised Controlled

Background: Scalable interventions to address COVID-19 mental health are needed. Our objective was to assess effects of mental health interventions for community-based children, adolescents, and adults. Methods: We searched 9 databases (2 Chinese-language) from December 31, 2019 to March 22, 2021. We included randomised controlled trials with non-hospitalised, non-quarantined participants of interventions to address COVID-19 mental health challenges. We synthesized results descriptively but did not pool quantitatively due to substantial heterogeneity of populations and interventions and concerns about risk of bias. Findings: We identified 9 eligible trials, including 3 well-conducted, well-reported trials that tested interventions designed specifically for COVID-19 mental health challenges, plus 6 trials of standard interventions (e.g., individual or group therapy, expressive writing, mindfulness recordings) minimally adapted for COVID-19, all with risk of bias concerns. Among the 3 COVID-19-specific intervention trials, one (N = 670) found that a self-guided, internet-based cognitive-behavioural intervention targeting dysfunctional COVID-19 worry significantly reduced COVID-19 anxiety (standardized mean difference [SMD] 0.74, 95% CI 0.58 to 0.90) and depression symptoms (SMD 0.38, 95% CI 0.22 to 0.55) in Swedish general population participants. A lay-delivered telephone intervention for homebound older adults in the United States (N = 240) and a peer-moderated education and support intervention for people with a rare autoimmune condition from 12 countries (N = 172) significantly improved anxiety (SMD 0.35, 95% CI 0.09 to 0.60; SMD 0.31, 95% CI 0.03 to 0.58) and depressive symptoms (SMD 0.31, 95% CI 0.05 to 0.56; SMD 0.31, 95% CI 0.07 to 0.55) 6-weeks post-intervention, but these were not significant immediately post-intervention. No trials in children or adolescents were identified. Interpretation: Internet-based programs for the general population and lay- or peer-delivered interventions for vulnerable groups may be effective, scalable options for public mental health in COVID-19. More well-conducted trials, including for children and adolescents, are needed.

scholarly journals Impact of social distancing measures for preventing coronavirus disease 2019 [COVID-19]: A systematic review and meta-analysis protocol

2020 ◽  
Author(s):  
Krishna Regmi ◽  
Cho Mar Lwin
Keyword(s):  
Public Health ◽  
Systematic Review ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
World Health ◽  
Controlled Trials ◽  
List Type ◽  
Social Distancing ◽  
Randomised Controlled ◽  
The Impact

AbstractIntroductionSocial distancing measures (SDMs) protect public health from the outbreak of coronavirus disease 2019 (COVID-19). However, the impact of SDMs has been inconsistent and unclear. This study aims to assess the effects of SDMs (e.g. isolation, quarantine) for reducing the transmission of COVID-19.Methods and analysisWe will conduct a systematic review meta-analysis research of both randomised controlled trials and non-randomised controlled trials. We will search MEDLINE, EMBASE, Allied & Complementary Medicine, COVID-19 Research and WHO database on COVID-19 for primary studies assessing the effects of SDMs (e.g. isolation, quarantine) for reducing the transmission of COVID-19, and will be reported in accordance with PRISMA statement. The PRISMA-P checklist will be used while preparing this protocol. We will use Joanna Briggs Institute guidelines (JBI Critical Appraisal Checklists) to assess the methodological qualities and synthesised performing thematic analysis. Two reviewers will independently screen the papers and extracted data. If sufficient data are available, the random-effects model for meta-analysis will be performed to measure the effect size of SDMs or the strengths of relationships. To assess the heterogeneity of effects, I2 together with the observed effects (Q-value, with degrees of freedom) will be used to provide the true effects in the analysis.Ethics and disseminationEthics approval and consent will not be required for this systematic review of the literature as it does not involve human participation. We will be able to disseminate the study findings using the following strategies: we will be publishing at least one paper in peer-reviewed journals, and an abstract will be presented at suitable national/international conferences or workshops. We will also share important information with public health authorities as well as with the World Health Organization. In addition, we may post the submitted manuscript under review to bioRxiv, medRxiv, or other relevant pre-print servers.Strengths and limitations of this studyTo our knowledge, this study will be the first systematic review to examine the impact of social distancing measures to reduce transmission of COVID-19.This study will offer highest level of evidence for informed decisions, drawing a broader framework.This protocol reduces the possibility of duplication, provides transparency to the methods and procedures that will be used, minimise potential biases and allows peer-review.This research is not externally funded, and therefore time and resource will be constrained.If included studies will be variable in sample size, quality and population, which may open to bias, and the heterogeneity of data will preclude a meaningful meta-analysis to measure the impact of specific SDMs

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