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Improving the reporting of pragmatic trials: an extension of the CONSORT statement
Background The CONSORT statement is intended to improve reporting of randomised controlled trials and focuses on minimising the risk of bias (internal validity). The applicability of a trial’s results (generalisability or external validity) is also important, particularly for pragmatic trials. A pragmatic trial (a term first used in 1967 by Schwartz and Lellouch) can be broadly defined as a randomised controlled trial whose purpose is to inform decisions about practice. This extension of the CONSORT statement is intended to improve the reporting of such trials and focuses on applicability. Methods At two, two-day meetings held in Toronto in 2005 and 2008, we reviewed the CONSORT statement and its extensions, the literature on pragmatic trials and applicability, and our experiences in conducting pragmatic trials. Recommendations We recommend extending eight CONSORT checklist items for reporting of pragmatic trials: the background, participants, interventions, outcomes, sample size, blinding, participant flow, and generalisability of the findings. These extensions are presented, along with illustrative examples of reporting, and an explanation of each extension. Adherence to these reporting criteria will make it easier for decision makers to judge how applicable the results of randomised controlled trials are to their own conditions. Empirical studies are needed to ascertain the usefulness and comprehensiveness of these CONSORT checklist item extensions. In the meantime we recommend that those who support, conduct, and report pragmatic trials should use this extension of the CONSORT statement to facilitate the use of trial results in decisions about health care.
Journal Article
Community-Partnered Cluster-Randomized Comparative Effectiveness Trial of Community Engagement and Planning or Resources for Services to Address Depression Disparities
ABSTRACT
BACKGROUND
Depression contributes to disability and there are ethnic/racial disparities in access and outcomes of care. Quality improvement (QI) programs for depression in primary care improve outcomes relative to usual care, but health, social and other community-based service sectors also support clients in under-resourced communities. Little is known about effects on client outcomes of strategies to implement depression QI across diverse sectors.
OBJECTIVE
To compare the effectiveness of
Community Engagement and Planning (CEP)
and
Resources for Services (RS)
to implement depression QI on clients’ mental health-related quality of life (HRQL) and services use.
DESIGN
Matched programs from health, social and other service sectors were randomized to community engagement and planning (promoting inter-agency collaboration) or resources for services (individual program technical assistance plus outreach) to implement depression QI toolkits in Hollywood-Metro and South Los Angeles.
PARTICIPANTS
From 93 randomized programs, 4,440 clients were screened and of 1,322 depressed by the 8-item Patient Health Questionnaire (PHQ-8) and providing contact information, 1,246 enrolled and 1,018 in 90 programs completed baseline or 6-month follow-up.
MEASURES
Self-reported mental HRQL and probable depression (primary), physical activity, employment, homelessness risk factors (secondary) and services use.
RESULTS
CEP was more effective than RS at improving mental HRQL, increasing physical activity and reducing homelessness risk factors, rate of behavioral health hospitalization and medication visits among specialty care users (i.e. psychiatrists, mental health providers) while increasing depression visits among users of primary care/public health for depression and users of faith-based and park programs (each
p
< 0.05). Employment, use of antidepressants, and total contacts were not significantly affected (each
p
> 0.05).
CONCLUSION
Community engagement to build a collaborative approach to implementing depression QI across diverse programs was more effective than resources for services for individual programs in improving mental HRQL, physical activity and homelessness risk factors, and shifted utilization away from hospitalizations and specialty medication visits toward primary care and other sectors, offering an expanded health-home model to address multiple disparities for depressed safety-net clients.
Journal Article
Women's Health Research
Even though slightly over half of the U.S. population is female, medical research historically has neglected the health needs of women. However, over the past two decades, there have been major changes in government support of women's health research-in policies, regulations, and the organization of research efforts. To assess the impact of these changes, Congress directed the Department of Health and Human Services (HHS) to ask the IOM to examine what has been learned from that research and how well it has been put into practice as well as communicated to both providers and women.
Women's Health Research finds that women's health research has contributed to significant progress over the past 20 years in lessening the burden of disease and reducing deaths from some conditions, while other conditions have seen only moderate change or even little or no change. Gaps remain, both in research areas and in the application of results to benefit women in general and across multiple population groups. Given the many and significant roles women play in our society, maintaining support for women's health research and enhancing its impact are not only in the interest of women, they are in the interest of us all.
eBook
A methodological systematic review of meta-ethnography conduct to articulate the complex analytical phases
Background
Decision making in health and social care requires robust syntheses of both quantitative and qualitative evidence. Meta-ethnography is a seven-phase methodology for synthesising qualitative studies. Developed in 1988 by sociologists in education Noblit and Hare, meta-ethnography has evolved since its inception; it is now widely used in healthcare research and is gaining popularity in education research. The aim of this article is to provide up-to-date, in-depth guidance on conducting the complex analytic synthesis phases 4 to 6 of meta-ethnography through analysis of the latest methodological evidence.
Methods
We report findings from a methodological systematic review conducted from 2015 to 2016. Fourteen databases and five other online resources were searched. Expansive searches were also conducted resulting in inclusion of 57 publications on meta-ethnography conduct and reporting from a range of academic disciplines published from 1988 to 2016.
Results
Current guidance on applying meta-ethnography originates from a small group of researchers using the methodology in a health context. We identified that researchers have operationalised the analysis and synthesis methods of meta-ethnography – determining how studies are related (phase 4), translating studies into one another (phase 5), synthesising translations (phase 6) and line of argument synthesis - to suit their own syntheses resulting in variation in methods and their application. Empirical research is required to compare the impact of different methods of translation and synthesis. Some methods are potentially better at preserving links with the context and meaning of primary studies, a key principle of meta-ethnography. A meta-ethnography can and should include reciprocal and refutational translation and line of argument synthesis, rather than only one of these, to maximise the impact of its outputs.
Conclusion
The current work is the first to articulate and differentiate the methodological variations and their application for different purposes and represents a significant advance in the understanding of the methodological application of meta-ethnography.
Journal Article
Essentials of community-based research
\"Community-based research (CBR) is the most commonly used method for serving community needs and effecting change through authentic, ethical, and meaningful social research. In this brief introduction to CBR, the real-world approach of noted experts Vera Caine and Judy Mill helps novice researchers understand the promise and perils of engaging in this research tradition. This book -outlines the basic steps and issues in the CBR process-from collaboratively designing and conducting the research with community members to building community capacity; -covers how to negotiate complicated questions of researcher control and ethics; -includes a chapter written by community partners, among the examples from numerous projects from around the world\"-- Provided by publisher.
Book
Improving the normalization of complex interventions: part 2 - validation of the NoMAD instrument for assessing implementation work based on normalization process theory (NPT)
Introduction
Successful implementation and embedding of new health care practices relies on co-ordinated, collective behaviour of individuals working within the constraints of health care settings. Normalization Process Theory (NPT) provides a theory of implementation that emphasises collective action in explaining, and shaping, the embedding of new practices. To extend the practical utility of NPT for improving implementation success, an instrument (NoMAD) was developed and validated.
Methods
Descriptive analysis and psychometric testing of an instrument developed by the authors, through an iterative process that included item generation, consensus methods, item appraisal, and cognitive testing. A 46 item questionnaire was tested in 6 sites implementing health related interventions, using paper and online completion. Participants were staff directly involved in working with the interventions. Descriptive analysis and consensus methods were used to remove redundancy, reducing the final tool to 23 items. Data were subject to confirmatory factor analysis which sought to confirm the theoretical structure within the sample.
Results
We obtained 831 completed questionnaires, an average response rate of 39% (range: 22–77%). Full completion of items was 50% (
n
= 413). The confirmatory factor analysis showed the model achieved acceptable fit (CFI = 0.95, TLI = 0.93, RMSEA = 0.08, SRMR = 0.03). Construct validity of the four theoretical constructs of NPT was supported, and internal consistency (Cronbach’s alpha) were as follows: Coherence (4 items, α = 0.71); Collective Action (7 items, α = 0.78); Cognitive Participation (4 items, α = 0.81); Reflexive Monitoring (5 items, α = 0.65). The normalisation scale overall, was highly reliable (20 items, α = 0.89).
Conclusions
The NoMAD instrument has good face validity, construct validity and internal consistency, for assessing staff perceptions of factors relevant to embedding interventions that change their work practices. Uses in evaluating and guiding implementation are proposed.
Journal Article