Feasibility of conducting a cohort randomised controlled trial assessing the effectiveness of a nurse-led package of care for knee pain.

OBJECTIVE: To evaluate the feasibility of conducting a cohort randomised-controlled trial (RCT) of a nurse-led package of care for knee pain and determine treatment sequence for use in a future trial. METHODS: Open label, three-arm, single-centre, mixed-methods, feasibility cohort RCT. Adults aged ≥40 years with moderate-to-severe knee pain for ≥3 months were eligible. Participants were randomised into groups A (non-pharmacological treatment first), B (pharmacological treatment first), or group C (usual care). The intervention was delivered over 26-weeks. Outcomes were dropout rate, recruitment rate, intervention fidelity, ability to collect outcome data and treatment acceptability. RESULTS: Seventeen participants were randomised and enrolled into each of groups A and B (5.2% recruitment rate), and 174 randomised to group C. Participant characteristics at randomisation were comparable across the three arms. COVID-19 paused the study from March-November-2020. Participants enrolled in groups A and B before March-2020 were withdrawn at restart. Of the 20 participants enrolled after restart, 18 completed the study (10% dropout). The nurse reported delivering most aspects of the intervention with high fidelity. Participants viewed the package of care as structured, supportive and holistic, they learnt about self-managing knee pain, and could engage with and follow the non-pharmacological treatment. Most found the non-pharmacological treatment more useful than the pharmacological treatment, preferring to receive it before or alongside analgesia. Many self-reported questionnaires were not fully completed. CONCLUSIONS: The nurse-led package of care for knee pain was acceptable with low dropout, although the cohort RCT design may not be feasible for a definitive trial. TRIAL REGISTRATION: clinicaltrials.gov; NCT03670706.

Inter-rater reliability of physiotherapists using the Action Research Arm Test in chronic stroke.

OBJECTIVES: The purpose of this study is to establish whether physiotherapists' ratings are consistent, when using the Action Research Arm Test (ARAT) to score a chronic stroke patient. METHODS: This was part of a large project establishing the reliability in chronic stroke. This study used a correlational design comparing the association between physiotherapist scores of the same patient, to establish the ARAT's inter-rater reliability. The COSMIN checklist was followed to enhance the methodology of the study. RESULTS: Twenty physiotherapists (8 female and 12 male) aged between 25 and 53 years were selected. There were no participant dropouts or withdrawals. The sample size was normally distributed. The physiotherapists appeared representative of the UK physiotherapy population, with the exception of gender. The distribution of scores showed a normal distribution with standard deviation of score of 1.9. The Kendall's W test showed 0.711 of agreement between the raters. The scores achieved statistical significance showing consistency between physiotherapists' scores with chronic stroke. Limitations of the study were the use of a small single center convenience sample that may reduce the generalizability of the findings. CONCLUSIONS: The ARAT is consistent when scored by physiotherapists in a chronic stroke population. The inter-rater reliability range was (0.70 to 0.90) which is categorized as good.

Test-retest reliability of physiotherapists using the action research arm test in chronic stroke.

[Purpose] The aim of this study was to determine whether physiotherapists (PT) scores are consistent over time when using Action Research Arm Test (ARAT) to assess upper limb (UL) function on a videotaped chronic stroke patient. [Participants and Methods] Quantitative correlational study. A convenience-snowball sample of 20 international PT (mean age and experience=32 ± 6.8 and 7.55 ± 7.4 years) used ARAT to score chronic stroke patient's UL function, observing a video at baseline and again ≈ 2 weeks later. Two sets of non-parametric ordinal data were assessed with Spearman's (rho) and the alpha (a) value was set at 0.01. Line of equality, Bland-Altman plots and Wilcoxon signed rank test were also considered. [Results] Spearman's rho was found ≈ 0.78 at a significance level of 0.00. ARAT was scored with a mean difference of 16.6 days and a mean change of 0.6 points was observed. Limits of agreement and coefficient of reproducibility were ± 2.3 and ± 2.6 respectively. The patient's arm impairment was categorised as moderate and floor or ceiling effects were not detected. [Conclusion] The results suggest that ARAT is consistent, valid and should be used by PT in chronic stroke.

An Exploration of Student Perception Toward Interprofessional High-Fidelity Clinical Simulation.

OBJECTIVES: Interprofessional education is recognized for its potential for collaboration and teamwork, reflecting clinical practice; however, existing literature for simulation-based interprofessional education does not include Physician Associate (PA) students. This initiative aimed to explore the students' perception of interprofessional clinical simulation for PA students and allied health professional (AHP) students as part of our program development. METHODS: A high-fidelity simulation session was designed and conducted for volunteering students from the PA, paramedic science, and physiotherapy courses. We used a mixed-method electronic questionnaire consisting of 15 statements rated on a numerical rating scale (0-5) and four open-ended questions with unlimited free-text responses to explore student perceptions. Inductive thematic analysis was used for qualitative analysis. The session design was underpinned by Allport's (intergroup) contact hypothesis with an emphasis on mutual intergroup differentiation. RESULTS: Forty-six students participated in the simulation teaching, with 48% (n = 22) providing feedback. Overall student perception was mainly positive toward the interprofessional simulation; however, some barriers to learning were recognized. Based on the evaluation of our initiative and existing literature, we propose 5 top tips to promote an effective learning experience for students. (1) Understand the importance of interprofessional collaboration. (2) Establish clear roles. (3) Plan the scenarios in advance. (4) Maintain equal status between groups. (5) Provide clear instructions and expectations. CONCLUSION: To our knowledge, this is the first study of high-fidelity interprofessional simulation involving PA and AHP students. We successfully explored student perception which highlighted aspects that can impact learning. This pilot study demonstrated that interprofessional simulation is a feasible and acceptable form of learning for our students and highlighted how to improve future interprofessional simulation teaching sessions.

Acceptability of a nurse-led non-pharmacological complex intervention for knee pain: Nurse and patient views and experiences.

OBJECTIVES: The overall purpose of this research programme is to develop and test the feasibility of a complex intervention for knee pain delivered by a nurse, and comprising both non-pharmacological and pharmacological interventions. In this first phase, we examined the acceptability of the non-pharmacological component of the intervention; issues faced in delivery, and resolved possible challenges to delivery. METHODS: Eighteen adults with chronic knee pain were recruited from the community. The intervention comprised holistic assessment, education, exercise, weight-loss advice (where appropriate) and advice on adjunctive treatments such as hot/cold treatments, footwear modification and walking aids. After nurse training, the intervention was delivered in four sessions spread over five weeks. Participants had one to one semi-structured interview at the end of the intervention. The nurse was interviewed after the last visit of the last participant. These were audio recorded and transcribed verbatim. Themes were identified by one author through framework analysis of the transcripts, and cross-checked by another. RESULTS: Most participants found the advice from the nurse easy to follow and were satisfied with the package, though some felt that too much information was provided too soon. The intervention changed their perception of managing knee pain, learning that it can be improved with self-management. However, participants thought that the most challenging part of the intervention was fitting the exercise regime into their daily routine. The nurse found discussion of goal setting to be challenging. CONCLUSION: The nurse-led package of care is acceptable within a research setting. The results are promising and will be applied in a feasibility randomised-controlled trial.

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.

OBJECTIVES: To evaluate fidelity of delivery of a nurse-led non-pharmacological complex intervention for knee pain. SETTING: Secondary care. Single-centre study. STUDY DESIGN: Mixed methods study. PARTICIPANTS: Eighteen 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. INTERVENTIONS: Nurse-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. METHODS: Each 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. RESULTS: Fourteen 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. CONCLUSIONS: A 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.

East Midlands knee pain multiple randomised controlled trial cohort study: cohort establishment and feasibility study protocol.

INTRODUCTION: Knee pain due to osteoarthritis (OA) is a common cause of disability. The UK National Institute for Health and Care Excellence OA guidelines recommend education, exercise and weight loss advice (if overweight) as core interventions before pharmacological adjuncts. However, implementation of these in primary care is often suboptimal. This study aims to develop a complex intervention with non-pharmacological and pharmacological components that can be delivered by nurses. The feasibility and acceptability of the intervention, and feasibility of undertaking a future cohort randomised controlled trial (RCT) will be explored. METHODS AND ANALYSIS: In phase 1, we will develop a training programme for nurses and evaluate the fidelity and acceptability of the non-pharmacological element of the intervention. Fidelity checklists completed by the nurse will be compared with video analysis of the treatment sessions. Patients and nurses will be interviewed to determine the acceptability of the intervention and explore challenges to intervention delivery. The non-pharmacological component will be modified based on the findings. In phase 2, we will assess the feasibility of conducting a cohort RCT comprising both the pharmacological and modified non-pharmacological components. We will compare three groups: group A will receive the non-pharmacological components delivered before pharmacological components; group B will receive pharmacological components followed by the non-pharmacological components; and group C (control arm) will continue to receive usual care. Study outcomes will be collected at three time points: baseline, 13 and 26 weeks after randomisation. Qualitative interviews will be conducted with a sample of participants from each of the two active intervention arms. ETHICS AND DISSEMINATION: This protocol was approved by the East Midlands-Derby Research Ethics Committee (18/EM/0288) and registered at ClinicalTrials.gov (protocol v4.0, 10/02/2020). The study will be reported in accordance with the Consolidated Standards of Reporting Trials guidance and standards. The results will be submitted for publication in peer-reviewed academic journals. TRIAL REGISTRATION NUMBER: NCT03670706.