Trial reportBMJ open2021
Fidelity assessment of nurse-led non-pharmacological package of care for knee pain in the package development phase of a feasibility randomised controlled trial based in secondary care: a mixed methods study.
Trial report in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03670706 (The East-Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study), which is not on this map. Cited by 6 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The East-Midlands Knee Pain Multiple Randomised Controlled Trial Cohort Study: Cohort Establishment and Feasibility Cohort-randomised Controlled Trial
Who cites it
6 citing papers in PubMed, 7 citations in OpenAlex.
- Feasibility of conducting a cohort randomized controlled trial assessing the effectiveness of a nurse-led package of care for knee pain.Rheumatology (Oxford, England) · 2024Trial
- Feasibility of a school-based peer-led high-intensity interval training intervention: the Young Fitness Leaders project.BMC public health · 2026Article
- Consolidated guidance for behavioral intervention pilot and feasibility studies.Pilot and feasibility studies · 2024Article
- Expert Perspectives on Pilot and Feasibility Studies: A Delphi Study and Consolidation of Considerations for Behavioral Interventions.Research square · 2023Article
- Article
- Acceptability of a nurse-led non-pharmacological complex intervention for knee pain: Nurse and patient views and experiences.PloS one · 2022Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 1 institution in 1 country.
Funding
Abstract
objectivesTo evaluate fidelity of delivery of a nurse-led non-pharmacological complex intervention for knee pain.
settingSecondary care. Single-centre study. STUDY
designMixed methods study.
participantsEighteen adults with chronic knee pain. INCLUSION CRITERIA: Age >40 years, knee pain present for longer than 3 months, knee pain for most days of the previous month, at least moderate pain in two of the five domains of Western Ontario and McMaster Universities Osteoarthritis Index pain scale.
interventionsNurse-led non-pharmacological intervention comprising assessment, education, exercise, use of hot/cold treatments, footwear modification, walking aids and weight-loss advice (if required). OUTCOMES: Primary: fidelity of delivery of intervention, secondary: nurses' experience of delivering intervention.
methodsEach intervention session with every participant was video recorded and formed part of fidelity assessment. Fidelity checklists were completed by the research nurse after each session and by an independent researcher, after viewing the video-recordings blinded to nurse ratings. Fidelity scores (%), percentage agreement and 95% Confidence Intervals (CI) were calculated. Two semi-structured interviews were conducted with the research nurse.
resultsFourteen participants completed all visits. 62 treatment sessions took place. Nurse self-report and assessor video rating scores for all 62 treatment sessions were included in fidelity assessment. Overall fidelity was higher on nurse self-report (97.7%) than on objective video-rating (84.2%). Percentage agreement between nurse self-report and video-rating was 73.3% (95% CI 71.3 to 75.3). Fidelity was lowest for advice on footwear and walking aids. The nurse reported difficulty advising on thermal treatments, footwear and walking aids, and did not feel confident negotiating achievable and realistic goals with participants.
conclusionsA trained research nurse can deliver most components of a non-pharmacological intervention for knee pain to a high degree of fidelity. Future research should assess intervention fidelity in a routine clinical setting, and examine its clinical and cost-effectiveness. TRIAL REGISTRATION NUMBER: NCT03670706.
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Registered trials
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