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- Chen, Kenneth, et al.
(författare)
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Recommendations for Core Outcome Domain Set for Whiplash Associated Disorders (CATWAD)
- 2019
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Ingår i: Clinical Journal of Pain. - : Lippincott Williams & Wilkins. - 0749-8047 .- 1536-5409. ; 35:9, s. 727-736
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Tidskriftsartikel (refereegranskat)abstract
- Objective: Inconsistent reporting of outcomes in clinical trials of treatments for Whiplash Associated Disorders (WAD) hinders effective data pooling and conclusions that can be drawn about the effectiveness of tested treatments. The aim of this study was to provide recommendations for core outcome domains that should be included in clinical trials of WAD. Methods: A three-step process was used. 1) A list of potential core outcome domains were identified from the published literature; 2) Researchers, health care providers, patients and insurance personnel participated and rated the importance of each domain via a three round Delphi survey. A priori criteria for consensus were established; 3) Experts comprising researchers, health care providers and a consumer representative participated in a multidisciplinary consensus meeting that made final decisions on the recommended core outcome domains. Results: The literature search identified 63 potential core domains. 223 participants were invited to partake in the Delphi surveys with 41.7% completing Round 1, 45.3% Round 2 and 51.4% Round 3. Eleven core domains met the criteria for inclusion across the entire sample. After the expert consensus meeting, six core domains were recommended: Physical Functioning, Perceived Recovery, Work and Social Functioning, Psychological Functioning, Quality of Life and Pain. Discussion: A 3-step process was used to recommend core outcome domains for clinical trials in WAD. Six core domains were recommended: Physical Functioning, Perceived Recovery, Work and Social Functioning, Psychological Functioning, Quality of Life and Pain. The next step is to determine the outcome measurement instruments for each of these domains.
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| 2. |
- Jones, Kelly M., et al.
(författare)
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Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context : a randomized controlled pilot study
- 2018
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Ingår i: Clinical Rehabilitation. - : SAGE Publications. - 0269-2155 .- 1477-0873. ; 32:8, s. 1086-1097
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To assess the feasibility of conducting a randomized controlled trial of an instructional and educational stroke DVD and determine the feasibility and preliminary efficacy of this intervention in a multinational context. Design: Non-funded, pilot randomized controlled trial of intervention versus usual care. Setting: International, multicentre, community-based. Participants: Community-living adults up to three years post stroke with moderate to severe disability and their nominated informal caregivers. Interventions: Intervention patients viewed and practised rehabilitation techniques demonstrated in the DVD over six weeks. Main measures: Trial feasibility by number of active recruitment sites, recruitment efficiency, randomization and follow-up. Intervention feasibility by patient and caregiver impressions. Preliminary efficacy by the quality of life – 5-level EuroQol-5D (EQ-5D) health status measure, General Health Questionnaire and Centre for Epidemiological Studies–Depression at two months. Results: In total, 14 recruitment sites were established across eight countries. Recruitment was achieved at nine (64%) sites. Over 16 months, 66 participants were recruited (mean (SD) age = 63.5 (12.47) years) and randomized to intervention (n = 34) and control (n = 32) groups. In total, 54 (82%) completed a follow-up assessment. Patient and/or caregiver comments about the benefits and barriers to accessing the intervention were mixed. There were no significant between-group differences in outcomes at two months (P > 0.05). Conclusion: Conducting a multinational trial of a stroke DVD requires full funding. The intervention was acceptable to some patients and their caregivers, yet a generalized education approach did not fully meet their needs and/or expectations. A more individualized method may be required to meet peoples’ changing needs during stroke recovery.
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