Randomised controlled trial of a behaviour change physiotherapy intervention to increase physical activity following hip and knee replacement: the PEP-TALK trial.

OBJECTIVE: To test the effectiveness of a behaviour change physiotherapy intervention to increase physical activity compared with usual rehabilitation after total hip replacement (THR) or total knee replacement (TKR). DESIGN: Multicentre, pragmatic, two-arm, open, randomised controlled, superiority trial. SETTING: National Health Service providers in nine English hospitals. PARTICIPANTS: 224 individuals aged ≥18 years, undergoing a primary THR or TKR deemed 'moderately inactive' or 'inactive'. INTERVENTION: Participants received either six, 30 min, weekly, group-based exercise sessions (usual care) or the same six weekly, group-based, exercise sessions each preceded by a 30 min cognitive behaviour discussion group aimed at challenging barriers to physical inactivity following surgery (experimental). RANDOMISATION AND BLINDING: Initial 75 participants were randomised 1:1 before changing the allocation ratio to 2:1 (experimental:usual care). Allocation was based on minimisation, stratifying on comorbidities, operation type and hospital. There was no blinding. MAIN OUTCOME MEASURES: Primary: University of California Los Angeles (UCLA) Activity Score at 12 months. Secondary: 6 and 12-month assessed function, pain, self-efficacy, kinesiophobia, psychological distress and quality of life. RESULTS: Of the 1254 participants assessed for eligibility, 224 were included (139 experimental: 85 usual care). Mean age was 68.4 years (SD: 8.7), 63% were women, 52% underwent TKR. There was no between-group difference in UCLA score (mean difference: -0.03 (95% CI -0.52 to 0.45, p=0.89)). There were no differences observed in any of the secondary outcomes at 6 or 12 months. There were no important adverse events in either group. The COVID-19 pandemic contributed to the reduced intended sample size (target 260) and reduced intervention compliance. CONCLUSIONS: There is no evidence to suggest attending usual care physiotherapy sessions plus a group-based behaviour change intervention differs to attending usual care physiotherapy alone. As the trial could not reach its intended sample size, nor a proportion of participants receive their intended rehabilitation, this should be interpreted with caution. TRIAL REGISTRATION NUMBER: ISRCTN29770908.

Statistical analysis plan for a pragmatic phase III randomised controlled trial examining behaviour change physiotherapy intervention to increase physical activity following hip and knee replacements: the PEP-TALK trial.

BACKGROUND: Total hip (THR) and total knee replacements (TKR) are two highly successful orthopaedic procedures that reduce pain for people with osteoarthritis. Previous evidence suggests that physical activity, at best, remains the same pre- to post-operatively, and in some instances declines. The PEP-TALK trial evaluates the effects of a group-based, behaviour change intervention on physical activity following a THR or TKR. METHODS: PEP-TALK is an open, phase III, pragmatic, multi-centre, parallel, two-arm, two-way superiority randomised controlled trial investigating the effectiveness of usual care plus a behaviour change therapy compared with usual care alone following primary THR or TKR. The primary outcome is the UCLA Activity Score at 12 months post-randomisation which will be analysed using a linear mixed effects model. Secondary outcomes measured at 6 months and 12 months after randomisation include the UCLA Activity Score, Lower Extremity Functional Scale, Oxford Hip/Knee Score, Numerical Rating Scale for Pain, Generalised Self-Efficacy Scale, Tampa Scale for Kinesiophobia, Hospital Anxiety and Depression Scale, EuroQoL EQ-5D-5L index and EQ-VAS and complications or adverse events. Full details of the planned analysis approaches for the primary and secondary outcomes, as well as the planned sensitivity analyses to be undertaken due to the COVID-19 pandemic, are described here. The PEP-TALK study protocol has been published previously. DISCUSSION: This paper provides details of the planned statistical analyses for the PEP-TALK trial. This is aimed to reduce the risk of outcome reporting bias and enhance transparency in reporting. TRIAL REGISTRATION: International Standard Randomised Controlled Trials database, ISRCTN Number: 29770908 . Registered on October 2018.

A Hybrid Virtual Fracture Clinic is Safe and Efficacious in the COVID-19 Era: Stay at Home and Save Lives.

Introduction The coronavirus disease 2019 (COVID-19) pandemic necessitated a change in the manner outpatient fracture clinics are conducted due to the need to reduce footfall in hospitals. While studies regarding virtual fracture clinics have shown these to be useful and effective, they focus exclusively on remote consultations. However, our service was bespoke to the patient - either a face-to-face, a telephone consultation or both, depending on patient need - a 'hybrid virtual fracture clinic' (HVFC). We report patient satisfaction and outcomes with this service from the first wave of the pandemic. Methods We retrospectively interviewed patients who availed of the HVFC service at our institution during the first two weeks of national lockdown in England from March 23 to April 5, 2020. The number and type of consultations, patient vulnerability to COVID-19, and type of management (surgical vs non-surgical) were among the factors taken into consideration. Patient experience was assessed using the Net Promoter Score (NPS), Customer Effort Score (CES), and Customer Satisfaction Score (CSS) on a scale of 0-10. Patient-reported outcomes were assessed using the EuroQol-5D-5L score (including EQ Visual Analogue Scale {EQ-VAS} scoring on a scale of 0-100). Results The mean overall NPS, CES, and CSS for the service were 7.32, 7.24, and 7.49, respectively. The mean self-reported EQ-VAS rating was 77.5. Of 442 consultations, 246 were conducted virtually; 10% were face-to-face, 29% virtual, and 61% were hybrid consultations. The HVFC resulted in a 55.65% reduction in footfall. Statistical analysis showed no significant difference across any outcome measure when compared between hybrid, virtual, and face-to-face consultations. Patients vulnerable to COVID-19 and those who did not require surgery tended to report better overall scores. Conclusion Our study indicates that the HVFC format can reduce patient footfall significantly (>50%) while providing effective and satisfactory outpatient care. There appears to be no difference in patient-reported outcomes between face-to-face consultations and hybrid or virtual consultations. Patients would recommend HVFC to family and friends, found it was easy to use, and reported good satisfaction with the service.