scholarly journals Protocol for the development of a core outcome set for evaluating mixed-diagnosis falls prevention interventions for people with Multiple Sclerosis, Parkinson’s Disease and stroke

2021 ◽  
Vol 4 ◽  
pp. 123
Author(s):  
Nicola O'Malley ◽  
Susan Coote ◽  
Amanda M Clifford
Keyword(s):  
Multiple Sclerosis ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Core Outcome Set ◽  
Delphi Survey ◽  
Falls Prevention ◽  
Core Outcome ◽  
Policy Makers ◽  
Outcome Set ◽  
Prevention Interventions

Background: Given the high incidence of falls and their associated negative effects, the development of effective falls prevention interventions for people with Multiple Sclerosis (MS), Parkinson's Disease (PD) and stroke is a priority. Currently the implementation of condition-specific falls prevention interventions is challenging in the community due to lack of participants and resources. Given the similarities in falls risk factors across stroke, PD and MS, the design of mixed-diagnosis interventions for groups comprising of people with these three neurological conditions may solve these implementation challenges. Having a core outcome set (COS) for evaluating these interventions would enable the comparison and combination of data, thereby facilitating progress in this research area. Therefore, the aim of this research study is to develop a COS for evaluating mixed-diagnosis falls prevention interventions for people with MS, PD and stroke. Methods: This will be a mixed-methods, international, multi-perspective Delphi consensus study with five stages. Stage one will involve the identification of potential outcomes through a systematic literature search, patient focus groups, and consultation with our Public and Patient Involvement (PPI) panel. The second stage will be the development of the Delphi survey using the outcomes elicited from stage one. Stage three will be the prioritisation of outcomes using a two-round online Delphi survey involving patients, clinicians, researchers and policy-makers/service-planners. The fourth stage will be to identify and recommend outcome measures and definitions. The final stage will be a consensus meeting with representatives from each stakeholder group to agree upon the final COS. Discussion: Adoption of this COS in future trials investigating the effectiveness of mixed-diagnosis falls prevention interventions for people with MS, PD and stroke will facilitate the comparison and combination of research findings. This should translate into improved decision-making by service-planners/policy-makers and clinicians regarding the implementation of evidence-based falls prevention interventions into practice.

scholarly journals Effectiveness of non-pharmacological falls prevention interventions for people with Multiple Sclerosis, Parkinson’s Disease and stroke: protocol for an umbrella review

2020 ◽  
Vol 3 ◽  
pp. 17
Author(s):  
Nicola O'Malley ◽  
Amanda M. Clifford ◽  
Laura Comber ◽  
Susan Coote
Keyword(s):  
Multiple Sclerosis ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Systematic Reviews ◽  
Neurological Diseases ◽  
Evaluation Framework ◽  
Falls Prevention ◽  
Umbrella Review ◽  
Prevention Interventions

Background: Falls are common among people with neurological diseases and are associated with many negative physical, psychosocial and economic consequences. Implementation of single diagnosis falls prevention interventions is currently problematic due to lack of participants and resources. Given the similarities in falls risk factors across stroke, Parkinson’s Disease (PD) and Multiple Sclerosis (MS), the development of an intervention designed for mixed neurological populations seems plausible and may provide a solution to current implementation challenges. This umbrella review aims to summarise the totality of evidence regarding the effectiveness of non-pharmacological falls prevention interventions for people with MS, PD and stroke and to identify the commonalities and differences between interventions that are effective for each disease to inform the development of an intervention for mixed diagnoses. Methods: This umbrella review will be conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Electronic databases and grey literature will be searched. Systematic reviews of randomised controlled trials (RCTS) and studies investigating the effects of non-pharmacological falls prevention interventions on falls outcomes among people with MS, PD and stroke will be included. Methodological quality of included reviews will be assessed using the Assessment of Multiple Systematic Reviews 2 tool. The Grading of Recommendations Assessments, Development and Evaluation framework will be used to rate the quality of evidence. A summary of evidence table and narrative synthesis will be utilised to clearly indicate the findings. Discussion: This umbrella review presents a novel and timely approach to synthesise existing falls literature to identify effective non-pharmacological interventions for people with MS, PD and stroke. Of importance, this umbrella review will use a robust methodology to explore the key differences and similarities in effective interventions for individuals with these neurological diseases to facilitate the development of an intervention for mixed neurological groups.

scholarly journals Effectiveness of non-pharmacological falls prevention interventions for people with Multiple Sclerosis, Parkinson’s Disease and stroke: protocol for an umbrella review

2020 ◽  
Vol 3 ◽  
pp. 17
Author(s):  
Nicola O'Malley ◽  
Amanda M. Clifford ◽  
Laura Comber ◽  
Susan Coote
Keyword(s):  
Multiple Sclerosis ◽  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Systematic Reviews ◽  
Evaluation Framework ◽  
Falls Prevention ◽  
Umbrella Review ◽  
Effective Interventions ◽  
Prevention Interventions

Background: Falls are common among people with neurological diseases and have many negative physical, psychosocial and economic consequences. Implementation of single-diagnosis falls prevention interventions is currently problematic due to lack of participants and resources. Given the similarities in falls risk factors across stroke, Parkinson’s Disease (PD) and Multiple Sclerosis (MS), the development of an intervention designed for mixed neurological populations seems plausible and may provide a pragmatic solution to current implementation challenges. This umbrella review aims to summarise the totality of evidence regarding the effectiveness of non-pharmacological falls prevention interventions for people with MS, PD and stroke and identify the commonalities and differences between effective interventions for each disease to inform the development of an evidence-based intervention that can be tailored for people with mixed diagnoses. Methods: This umbrella review will be conducted and reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. 15 electronic databases and grey literature will be searched. Systematic reviews of randomised controlled trials and studies investigating the effects of non-pharmacological falls prevention interventions on falls outcomes among people with MS, PD and stroke will be included. Methodological quality of included reviews will be assessed using the Assessment of Multiple Systematic Reviews 2 tool. The Grading of Recommendations Assessments, Development and Evaluation framework will be used to rate the quality of evidence. A summary of evidence table and narrative synthesis will be utilised to clearly indicate the findings. Discussion: This umbrella review presents a novel and timely approach to synthesise existing falls literature to identify effective non-pharmacological interventions for people with MS, PD and stroke. Of importance, a robust methodology will be used to explore the differences and similarities in effective interventions for individuals with these neurological conditions to facilitate the development of an intervention for these mixed neurological groups.

scholarly journals Development of a core outcome set for diabetes after pregnancy prevention interventions (COS-DAP): a study protocol

Trials ◽  
2018 ◽  
Vol 19 (1) ◽  
Author(s):  
Karoline Kragelund Nielsen ◽  
Sharleen O’Reilly ◽  
Nancy Wu ◽  
Kaberi Dasgupta ◽  
Helle Terkildsen Maindal
Keyword(s):  
Study Protocol ◽  
Core Outcome Set ◽  
Pregnancy Prevention ◽  
Core Outcome ◽  
Outcome Set ◽  
Prevention Interventions

scholarly journals Choosing outcomes for a core outcome set: does provision of feedback between delphi survey rounds help prioritise items?

Trials ◽  
2015 ◽  
Vol 16 (S2) ◽  
Author(s):  
Karen Coulman ◽  
Sara Brookes ◽  
Katy Chalmers ◽  
James Hopkins ◽  
Noah Howes ◽  
...  
Keyword(s):  
Core Outcome Set ◽  
Delphi Survey ◽  
Core Outcome ◽  
Outcome Set

scholarly journals Development of a Core Outcome Set for Effectiveness Studies of Breech Birth at Term (Breech-COS)- An International Multi-Stakeholder Delphi Study: Study Protocol

2021 ◽  
Author(s):  
Shawn Walker ◽  
Tisha Dasgupta ◽  
Andrew Shennan ◽  
Jane Sandall ◽  
Catey Bunce ◽  
...  
Keyword(s):  
Literature Review ◽  
Core Outcome Set ◽  
Delphi Survey ◽  
Neonatal Outcomes ◽  
Core Outcome ◽  
Care Providers ◽  
Outcome Set ◽  
Increased Risk ◽  
Breech Birth ◽  
Effectiveness Studies

Abstract Background: Women pregnant with a breech-presenting foetus at term are at increased risk of adverse pregnancy outcomes. The most common intervention used to improve neonatal outcomes is planned delivery by caesarean section. But this is not always possible, and some women prefer to plan a vaginal birth. A number of providers have proposed alternative interventions, such as delivery protocols or specialist teams, but heterogeneity in reported outcomes and their measurements prevents meaningful comparisons. The aim of this paper is to present a protocol for a study to develop a Breech Core Outcome Set (Breech-COS) for studies evaluating the effectiveness of interventions to improve outcomes associated with term breech birth.Methods: The development of a Breech-COS includes three phases. First, a systematic literature review will be conducted to identify outcomes previously used in effectiveness studies of breech birth at term. A focus group discussion will be conducted with the study’s pre-established Patient and Public Involvement (PPI) group, to enable service user perspectives on the results of literature review to influence the design of Delphi survey instrument. Second, an international Delphi survey will be conducted to prioritize outcomes for inclusion in the Breech-COS from the point of view of key stakeholders, including perinatal care providers and families who have experienced a term breech pregnancy. Finally, a consensus meeting will be held with stakeholders to ratify the Breech-COS and disseminate findings for application in future effectiveness studies.Discussion: The expectation is that the Breech-COS will always be collected in all clinical trials, audits of practice and other forms of observation research that concern breech birth at term, along with other outcomes of interest. This will facilitate comparing, contrasting and combining studies with the ultimate goal of improved maternal and neonatal outcomes. Trial registration: Core Outcome Measures in Effectiveness Trials (COMET): #1749; Core Outcomes in Women’s and Newborn Health (CROWN) Initiative.

scholarly journals Development of a core outcome set for the evaluation of interventions to enhance trial participation decisions on behalf of adults who lack capacity to consent: a mixed methods study (COnSiDER Study)

2021 ◽  
Author(s):  
Victoria Shepherd ◽  
Fiona Wood ◽  
Michael Robling ◽  
Elizabeth Randell ◽  
Kerenza Hood
Keyword(s):  
Outcome Measurement ◽  
Core Outcome Set ◽  
Consensus Meeting ◽  
Delphi Survey ◽  
Additional Patient ◽  
Trial Participation ◽  
Core Outcome ◽  
Capacity To Consent ◽  
Outcome Set ◽  
Participation Decisions

Abstract BackgroundTrials involving adults who lack capacity to provide consent for themselves rely on proxy or surrogate decision-makers, usually a family member, to make decisions about participation. Following decades of innovations to improve informed consent in trials, the first interventions to enhance proxy decisions about trial participation are now being developed. However, a lack of standardised outcome measurement in the evaluation of these novel interventions will impede comparisons between their effectiveness. The aim of this study was to establish an agreed standardised core outcome set (COS) for use when evaluating interventions to improve proxy decisions about trial participation on behalf of adults who lack capacity to consent.MethodsWe used established methods to develop the COS including a consensus study with key stakeholder groups comprising those who will use the COS in research (researchers and healthcare professionals) and patients or their representatives. Following a scoping review to identify candidate items, we used a modified two-round Delphi survey to achieve consensus on core outcomes, with equivocal items taken to a consensus meeting for discussion. The COS was finalised following an online consensus meeting in October 2020.ResultsA total of 28 UK stakeholders (5 researchers, 10 trialists, 3 patient/family representatives, 7 recruiters and 3 advisors/approvers) participated in the online Delphi survey to rank candidate items. Items were broadly grouped into three categories: how family members make decisions, their experiences of making decisions, and the personal aspects that influence the decision. Following the Delphi survey, 27 items were included and ten items exhibited no consensus which required discussion at the consensus meeting. Sixteen participants attended the meeting, including additional patient/family representatives invited to increase representation from this key group. We reached consensus for the inclusion of 28 outcome items, including one selected at the consensus meeting.ConclusionsThe study identified outcomes that should be measured as a minimum in all evaluations of interventions to enhance proxy decisions about trials. Further work is required to identify appropriate measures and timing of outcome measurement. Enhancing the quality of proxy decisions will help improve trial participation decisions for these vulnerable groups. Trial registration: The study is registered on the COMET database (https://www.comet-initiative.org/Studies/Details/1409)

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