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PloS One 2024Co-design methodology seeks to actively engage end-users in developing interventions. It is increasingly used to design stroke interventions; however, limited guidance... (Review)
Review
BACKGROUND
Co-design methodology seeks to actively engage end-users in developing interventions. It is increasingly used to design stroke interventions; however, limited guidance exists, particularly with/for individuals with stroke who have diverse cognitive, physical and functional abilities. Thus, we describe 1) the extent of existing research that has used co-design for stroke intervention development and 2) how co-design has been used to develop stroke interventions among studies that explicitly used co-design, including the rationale, types of co-designed stroke interventions, participants involved, research methodologies/approaches, methods of incorporating end-users in the research, co-design limitations, challenges and potential strategies reported by researchers.
MATERIALS AND METHODS
A scoping review informed by Joanna Briggs Institute and Arksey & O'Malley methodology was conducted by searching nine databases on December 21, 2022, to locate English-language literature that used co-design to develop a stroke intervention. Additional data sources were identified through a hand search. Data sources were de-duplicated, and two research team members reviewed their titles, abstracts and full text to ensure they met the inclusion criteria. Data relating to the research objectives were extracted, analyzed, and reported numerically and descriptively.
RESULTS
Data sources used co-design for stroke intervention development with (n = 89) and without (n = 139) explicitly using the term 'co-design.' Among studies explicitly using co-design, it was commonly used to understand end-user needs and generate new ideas. Many co-designed interventions were technology-based (65%), and 48% were for physical rehabilitation or activity-based. Co-design was commonly conducted with multiple participants (82%; e.g., individuals with stroke, family members/caregivers and clinicians) and used various methods to engage end-users, including focus groups and workshops. Limitations, challenges and potential strategies for recruitment, participant-engagement, contextual and logistical and ethics of co-designed interventions were described.
CONCLUSIONS
Given the increasing popularity of co-design as a methodology for developing stroke interventions internationally, these findings can inform future co-designed studies.
Topics: Humans; Research Design; Focus Groups; Data Management; Stroke
PubMed: 38354160
DOI: 10.1371/journal.pone.0297162 -
PloS One 2021Many healthcare interventions are complex, consisting of multiple, possibly interacting, components. Several methodological articles addressing complex interventions in... (Review)
Review
Many healthcare interventions are complex, consisting of multiple, possibly interacting, components. Several methodological articles addressing complex interventions in the meta-analytical context have been published. We hereby provide an overview of methods used to evaluate the effects of complex interventions with meta-analytical models. We summarized the methodology, highlighted new developments, and described the benefits, drawbacks, and potential challenges of each identified method. We expect meta-analytical methods focusing on components of several multicomponent interventions to become increasingly popular due to recently developed, easy-to-use, software tools that can be used to conduct the relevant analyses. The different meta-analytical methods are illustrated through two examples comparing psychotherapies for panic disorder.
Topics: Animals; Data Analysis; Delivery of Health Care; Humans; Meta-Analysis as Topic; Research Design; Software
PubMed: 33556155
DOI: 10.1371/journal.pone.0246631 -
International Journal of Environmental... Apr 2020It is widely recognized that public health interventions benefit from community engagement and leadership, yet there are challenges to evaluating complex, community-led...
It is widely recognized that public health interventions benefit from community engagement and leadership, yet there are challenges to evaluating complex, community-led interventions assuming hierarchies of evidence derived from laboratory experimentation and clinical trials. Particular challenges include, first, the inconsistency of the intervention across sites and, second, the absence of researcher control over the sampling frame and methodology. This report highlights these challenges as they played out in the evaluation of a community-organized health project in South London. The project aimed to benefit maternal mental health, health literacy, and social capital, and especially to engage local populations known to have reduced contact with statutory services. We evaluated the project using two studies with different designs, sampling frames, and methodologies. In one, the sampling frame and methodology were under community control, permitting a comparison of change in outcomes before and after participation in the project. In the other, the sampling frame and methodology were under researcher control, permitting a case-control design. The two evaluations led to different results, however: participants in the community-controlled study showed benefits, while participants in the researcher-controlled study did not. The principal conclusions are that while there are severe challenges to evaluating a community-led health intervention using a controlled design, the measurement of pre-/post-participation changes in well-defined health outcomes should typically be a minimum evaluation requirement, and confidence in attributing causation of any positive changes to participation can be increased by use of interventions in the project and in the engagement process itself that have a credible theoretical and empirical basis.
Topics: Case-Control Studies; Community Health Services; Community Participation; Female; Health Literacy; Humans; London; Maternal Health; Mental Health; Research Design; Social Capital
PubMed: 32272680
DOI: 10.3390/ijerph17072523 -
BMJ Open Oct 2022An impoverished medical workforce is a global phenomenon, which can impact patient care significantly. Greater flexibility in working patterns is one approach...
INTRODUCTION
An impoverished medical workforce is a global phenomenon, which can impact patient care significantly. Greater flexibility in working patterns is one approach policy-makers adopt to address this issue, and the expansion of less than full-time (LTFT) working forms part of this. Studies suggest that LTFT working has the potential to improve recruitment and retention by aligning with how doctors increasingly want to balance their careers with other commitments and interests. What is less well understood are the influencing factors and outcomes related to LTFT working among doctors. This protocol outlines the methodology for a systematic review that will evaluate existing knowledge on LTFT working in the medical profession.
METHODS AND ANALYSIS
The Preferred Reporting Items for Systematic Reviews and Meta Analyses guidelines will be followed. Embase, MEDLINE, PsycINFO, Health Management Information Consortium, Web of Science, Cochrane Library, Healthcare Administration, and Applied Social Sciences Index and Abstracts will be searched for studies published up to March 2022. Unpublished literature from EThos and ProQuest Dissertations & Theses Global will also be searched. Bibliographic searching, citation searching and handsearching will be used to retrieve additional papers. Authors will be contacted for data or publications if necessary. Two independent reviewers will undertake study screening, data extraction and quality assessment, with disagreements resolved by consensus or by a third reviewer if necessary. Data synthesis will be by narrative synthesis and meta-analysis if possible.
ETHICS AND DISSEMINATION
The proposed study does not require ethical approval; however, it forms part of a larger body of research on the impact of LTFT working on the medical workforce for which ethics approval has been granted by the Research Ethics Committee at University College London. Findings will be published in a peer-reviewed journal and will be presented at national and international conferences.
PROSPERO REGISTRATION NUMBER
CRD42022307174.
Topics: Health Personnel; Humans; London; Meta-Analysis as Topic; Research Design; Systematic Reviews as Topic
PubMed: 36229152
DOI: 10.1136/bmjopen-2022-062356 -
Transplant International : Official... Aug 2016The number of clinical trials in solid organ transplantation is progressively increasing year on year, but the quality of design and reporting still varies considerably.... (Review)
Review
The number of clinical trials in solid organ transplantation is progressively increasing year on year, but the quality of design and reporting still varies considerably. The constraints on organ availability, improving short-term outcomes, ethics and timescales involved in organ transplantation present unique challenges for trials in this field. An understanding of the methodology and potential pitfalls in clinical research is essential both to interpret trial results and to design robust studies. This review summarizes the scope and quality of reporting in existing transplant clinical trials and details aspects of clinical trial methodology with particular relevance to transplantation. We highlight initiatives designed to improve the quality of this process to ensure that the results of clinical trials are robust, well reported and of use in everyday clinical practice.
Topics: Clinical Trials as Topic; Endpoint Determination; Evidence-Based Medicine; Graft Survival; Humans; Organ Transplantation; Random Allocation; Research Design; Time Factors
PubMed: 26749215
DOI: 10.1111/tri.12743 -
Health Expectations : An International... Aug 2018A significant challenge in Patient and Public Involvement and Engagement (PPIE) in health research is to include a wide range of opinions and experiences, including from...
BACKGROUND
A significant challenge in Patient and Public Involvement and Engagement (PPIE) in health research is to include a wide range of opinions and experiences, including from those who repeatedly find themselves at the margins of society.
OBJECTIVE
To contribute to the debate around PPIE by introducing a bottom-up methodology: cultural animation (CA). Cultural Animation is an arts-based methodology of knowledge co-production and community engagement which employs a variety of creative and participatory exercises to help build trusting relationships between diverse participants (expert and non-experts) and democratize the process of research.
DESIGN
Three CA full-day workshops for the research project "A Picture of Health."
PARTICIPANTS
Each workshop was attended by 20-25 participants including 4 academics, 5 retired health professionals who volunteered in the local community and 15 community members. Participants ranged in age from 25 to 75 years, and 80% of the participants were women over the age of 60.
RESULTS
The CA workshops unearthed a diversity of hidden assets, increased human connectivity, led to rethinking of and co-creating new health indicators and enabled participants to think of community health in a positive way and to consider what can be developed.
DISCUSSION
Cultural animation encourages participants to imagine and create ideal pictures of health by experimenting with new ways of working together.
CONCLUSION
We conclude by highlighting the main advantages to PPIE as follows: CA provides a route to co-produce research agendas, empowers the public to engage actively with health professionals and make a positive contribution to their community.
Topics: Aged; Community Participation; Community-Based Participatory Research; Cooperative Behavior; Empathy; Female; Focus Groups; Health Services Research; Humans; Male; Patient Participation; Research Design; Trust
PubMed: 29532582
DOI: 10.1111/hex.12677 -
Journal of Clinical Psychopharmacology Jun 2018Personalized (N-of-1) trials are single-patient, crossover-design trials that may be useful for personalizing the selection of depression treatments. We conducted a... (Review)
Review
PURPOSE/BACKGROUND
Personalized (N-of-1) trials are single-patient, crossover-design trials that may be useful for personalizing the selection of depression treatments. We conducted a systematic review of published N-of-1 trials for depression to determine the feasibility and suitability of this methodology for personalizing depression care.
METHODS/PROCEDURES
Electronic databases were searched from database inception through October 2016. Studies were selected if they enrolled depressed patients, included a within-subject crossover design, and systematically assessed depressive symptoms during the N-of-1 trial.
FINDINGS/RESULTS
Five eligible studies reporting on 47 depressed patients (range, 1-18 patients) were identified. Two studies were conducted among adults with treatment-resistant depression, 1 study among depressed inpatients, and 2 studies among patients from special populations (geriatric nursing home, human immunodeficiency virus-associated encephalopathy). All studies evaluated the effects of pharmacologic treatments (methylphenidate, D-amphetamine, ketamine, and sulpiride). Three studies compared an off-label treatment with placebo, 1 study compared 2 off-label treatments, and 1 study compared escalating doses of an off-label treatment with placebo. All 4 studies with more than 1 participant demonstrated heterogeneous treatment effects. All studies produced data that could personalize treatment selection for individual patients. No studies reported on recruitment challenges, compliance with self-tracking, or satisfaction with participation.
IMPLICATIONS/CONCLUSIONS
The feasibility of N-of-1 trials for depression was demonstrated for a limited number of second-line pharmacologic treatments in treatment-resistant patients or in patients with comorbidities that would have excluded them from conventional randomized controlled trials. Additional research is needed to determine whether N-of-1 trials are suitable for improving the selection of depression treatments in clinical practice.
Topics: Antidepressive Agents; Cross-Over Studies; Depression; Humans; Patient Selection; Precision Medicine; Research Design
PubMed: 29596148
DOI: 10.1097/JCP.0000000000000864 -
Journal of Prosthodontic Research Jan 2011The baseline standards for minimally acceptable science are improving as the understanding of the scientific method improves. Journals publishing research papers are... (Review)
Review
The baseline standards for minimally acceptable science are improving as the understanding of the scientific method improves. Journals publishing research papers are becoming more and more rigorous. For example, in 2001 a group of authors evaluated the quality of clinical trials in anesthesia published over a 20 year period [Pua et al., Anesthesiology 2001;95:1068-73]. The authors divided the time into 3 subgroups and analyzed and compared the quality assessment score from research papers in each group. The authors reported that the scientific quality scores increased significantly in this time, showing more randomization, sample size calculation and blinding of studies. Because every journal strives to have a high scientific impact factor, research quality is critical to this goal. This means novice researchers must study, understand and rigorously avoid the common mistakes described in this review. Failure to do so means the hundreds and hundreds of hours of effort it takes to conduct and write up a clinical trial will be for naught, in that the manuscript with be rejected or worse yet, ignored. All scientists have a responsibility to understand research methods, conduct the best research they can and publish the honest and unbiased results.
Topics: Biomedical Research; Clinical Protocols; Journal Impact Factor; Language; Meta-Analysis as Topic; Research Design; Sample Size; Statistics as Topic
PubMed: 21095178
DOI: 10.1016/j.jpor.2010.09.002 -
Orphanet Journal of Rare Diseases Oct 2018Where there are a limited number of patients, such as in a rare disease, clinical trials in these small populations present several challenges, including statistical... (Review)
Review
Where there are a limited number of patients, such as in a rare disease, clinical trials in these small populations present several challenges, including statistical issues. This led to an EU FP7 call for proposals in 2013. One of the three projects funded was the Innovative Methodology for Small Populations Research (InSPiRe) project. This paper summarizes the main results of the project, which was completed in 2017.The InSPiRe project has led to development of novel statistical methodology for clinical trials in small populations in four areas. We have explored new decision-making methods for small population clinical trials using a Bayesian decision-theoretic framework to compare costs with potential benefits, developed approaches for targeted treatment trials, enabling simultaneous identification of subgroups and confirmation of treatment effect for these patients, worked on early phase clinical trial design and on extrapolation from adult to pediatric studies, developing methods to enable use of pharmacokinetics and pharmacodynamics data, and also developed improved robust meta-analysis methods for a small number of trials to support the planning, analysis and interpretation of a trial as well as enabling extrapolation between patient groups. In addition to scientific publications, we have contributed to regulatory guidance and produced free software in order to facilitate implementation of the novel methods.
Topics: Humans; Rare Diseases; Research Design
PubMed: 30359266
DOI: 10.1186/s13023-018-0919-y -
Nutrition & Dietetics: the Journal of... Jul 2021Internal coherence in research refers to the alignment between ontology (nature of reality), epistemology (nature of knowledge), axiology (values), methodology and... (Review)
Review
AIM
Internal coherence in research refers to the alignment between ontology (nature of reality), epistemology (nature of knowledge), axiology (values), methodology and methods and is an important but often overlooked element of research quality. We therefore aimed to illustrate the concept of internal coherence in nutrition and dietetics research, and its importance beyond individual elements of study quality.
METHOD
A targeted literature search in Nutrition and Dietetics was used to identify research illustrating one example of three main approaches to research (scientific, interpretive and critical inquiry) published between November 2017 and November 2020. Studies were included if they related to education research based on the expertise of the authors, and illustrated diverse points about internal coherence. The authors independently critiqued included studies for internal coherence and synthesised their findings.
RESULTS
From 76 manuscripts, 14 were identified as describing education research. Of the three selected studies that were critiqued, all had elements of internal coherence, in particular alignment between epistemology and methodology. However, each had elements of misalignment too, specifically between epistemology, axiology and method. The results point to the profession's historical groundings privileging the scientific approach, showing how this can yield misalignments, particularly when describing the limitations of interpretive and critical inquiry approaches.
CONCLUSION
This review demonstrates the importance of internal coherence as a marker of quality, over and above existing quality assessment checklists for qualitative and quantitative methodologies. As such, it can help authors, reviewers and editors to improve the quality of nutrition and dietetics research and its reporting.
Topics: Dietetics; Humans; Nutritional Status; Research Design
PubMed: 34151511
DOI: 10.1111/1747-0080.12680