Experiences of participant and public involvement in an international randomized controlled trial for people living with dementia and their informal caregivers.

BACKGROUND: This study was initiated and co-designed by a Participant and Public Involvement (PPI) group attached to HOMESIDE, a randomized controlled trial that investigated music and reading interventions for people living with dementia and their family caregivers across five countries: Australia, Germany, Norway, Poland, and the UK. The aim was to capture experiences of PPI across the five countries, explore the benefits and challenges of PPI in dementia research, and identify contributions made to the study. METHODS: We surveyed PPI members and academic researchers who collaborated on the HOMESIDE study. The survey was co-designed through consultation with PPI members and academics, alongside a small scoping literature review. Survey questions covered four topics: (1) expectations for PPI, (2) perceived contributions of PPI to the research study, (3) benefits and challenges of PPI, and (4) recommendations for future PPI in dementia research. RESULTS: There were 23 responses, representing 50% of the PPI members (n = 16) and 29% of academics (n = 7). PPI was found to be beneficial to the research and individuals involved. Contributions to the research included supporting recruitment and publicity, advising on the design of participant-facing materials, guiding the design and delivery of the interventions, and identifying cultural differences affecting research delivery. PPI members benefited from building connections, sharing experiences and receiving support, learning about dementia and research, and gaining new unexpected experiences. Academics learned about the realities of living with dementia, which they felt informed and grounded their work. Several challenges were identified, including the need for clear expectations and objectives, inconsistency of PPI members across research stages, limitations of meeting online versus in-person, scheduling difficulties, and language barriers. CONCLUSIONS: This study identifies important considerations for implementing PPI within dementia studies and international healthcare research more broadly. Our findings guided the development of five recommendations: (1) involve PPI members as early as possible and throughout the research process; (2) create a space for constructive criticism and feedback; (3) have clear tasks, roles, and expectations for PPI members; (4) involve PPI members with a diverse range of experiences and backgrounds; and (5) embed infrastructure and planning to support PPI.

Participant and Public Involvement (PPI) brings the knowledge of those with lived experience into research to improve research relevance and delivery. Our international study, called HOMESIDE, explored the benefits of music and reading activities for people with dementia and their family caregivers across five countries: Australia, Germany, Norway, Poland, and the UK. The study's PPI members included people with dementia, family carers, and healthcare professionals, who met regularly with the research team throughout the 3-year study. The current article reports the findings of a co-designed survey about PPI within HOMESIDE. Initiated by the HOMESIDE PPI members, we carried out a survey of PPI members and academics who worked on the study to learn about the unique experiences, perspectives, and contributions of PPI across the international research team.Our findings show that PPI helped to publicize the study, improved recruitment of research participants, and informed delivery of the interventions. Another important outcome was learning from each other; PPI members learned about dementia research and academics learned about the realities of living with dementia. However, the survey also highlighted challenges, including managing expectations, scheduling difficulties, and language barriers.To support PPI in future dementia research, we highlight five recommendations: (1) involve PPI members as early as possible and throughout the research process; (2) create a space for constructive criticism and feedback; (3) have clear tasks, roles, and expectations for PPI members; (4) involve PPI members with a diverse range of experiences and backgrounds; and (5) embed infrastructure and planning to support PPI.

PREHAB FAI- Prehabilitation for patients undergoing arthroscopic hip surgery for Femoroacetabular Impingement Syndrome -Protocol for an assessor blinded randomised controlled feasibility study.

BACKGROUND: The past decade has seen an exponential growth of minimally invasive surgical procedures. Procedures such as hip arthroscopy have rapidly grown and become the standard of care for patients with Femoroacetabular Impingement Syndrome (FAIS). Although, the results of such procedures are encouraging, a large proportion of patients do not achieve optimal outcomes due to chronicity and deconditioning as a result of delay in diagnosis and increased waiting times amongst other factors. In a recent systematic review and meta-analysis of randomised control trials, moderate certainty evidence supported prehabilitation over standard care in optimising several domains including muscle strength, pain and health related quality of life in patients undergoing orthopaedic surgical interventions. However, the role of prehabilitation in patients with FAI syndrome undergoing hip arthroscopy has received little attention. AIM: To evaluate the feasibility, suitability, acceptability and safety of a prehabilitation programme for FAI to inform a future definitive randomised control trial to assess effectiveness. METHODS: A systematically developed prehabilitation intervention based on a literature review and international consensus will be utilised in this study. A mixed methodology encompassing a two-arm randomised parallel study alongside an embedded qualitative component will be used to answer the study objectives. Patients will be recruited from a tertiary referral NHS centre for young adult hip pathology in the UK. Patient reported outcomes such as iHOT-12, Brief Pain Inventory Scale (Short form), Hospital Anxiety and Depression Scale and Patient Global Impression of Change score will be obtained alongside objective measurements such as Muscle Strength and Star Excursion Balance Test at various time points. Outcome measures will be obtained at baseline (prior to prehabilitation intervention), after prehabilitation before surgery, and at 6 weeks+/- 4 weeks and 6 months +/- 4 weeks (planned primary endpoint for definitive RCT) postoperatively when participants attend the research site for clinical care and remotely at 12 months +/- 4 weeks postoperatively. Mean change and 95% CI, and effect size of outcome measures will be used to determine the sample size for a future RCT. For the qualitative component, in depth face-to-face semi-structured interviews with physiotherapists and focus groups with participants will be conducted to assess the feasibility, suitability, and acceptability of the prehabilitation intervention using a predetermined success criteria. All qualitative data will be recorded, transcribed verbatim and thematically analysed. DISCUSSION: This study will be first of its kind to evaluate a systematically developed prehabilitation intervention for patients with FAIS undergoing hip arthroscopy. This study will provide important preliminary data to inform feasibility of a definitive RCT in the future to evaluate effectiveness of a prehabilitation intervention. TRIAL REGISTRATION: ISRCTN 15371248, 09/03/2023. TRIAL PROTOCOL: Version 2.3, 26th June 2023.

Clinical Equipoise in the Management of Patients With Femoroacetabular Impingement Syndrome and Concomitant Tönnis Grade 2 Hip Osteoarthritis or Greater: An International Expert-Panel Delphi Study.

PURPOSE: To gather global-expert opinion on the management of patients with femoroacetabular impingement syndrome (FAIS) and Tönnis grade 2 hip osteoarthritis (OA) or greater. METHODS: An internet-based modified Delphi methodology was used via an online platform (Online Surveys) using the CREDES (Conducting and Reporting Delphi Studies) guidelines. The expert panel comprised 27 members from 18 countries: 21 orthopaedic surgeons (78%), 5 physiotherapists (18%), and 1 dual orthopaedic surgeon-sport and exercise medicine physician (4%). Comments and suggestions were collected during each round, and amendments were performed for the subsequent round. Between each pair of rounds, the steering panel provided the experts with a summary of results and amendments. Consensus was set a priori as minimum agreement of 80%. RESULTS: Complete participation (100%) was achieved in all 4 rounds. A final list of 10 consensus statements was formulated. The experts agreed that there is no single superior management strategy for FAIS with Tönnis grade 2 OA and that Tönnis grade 3 OA and the presence of bilateral cartilage defects (acetabular and femoral) is a contraindication for hip preservation surgery. Nonoperative management should include activity modification and physiotherapy with hip-specific strengthening, lumbo-pelvic mobility training, and core strengthening. There was no consensus on the need for 3-dimensional imaging for initial quantification of joint degeneration. CONCLUSIONS: There is clinical equipoise in terms of the best management strategy for patients with FAIS and Tönnis grade 2 OA, and therefore, there is an urgent need to perform a randomized controlled trial for this cohort of patients to ascertian the best management strategy. LEVEL OF EVIDENCE: Level V, expert opinion.

Prehabilitation for Patients Undergoing Orthopedic Surgery: A Systematic Review and Meta-analysis.

Importance: Prehabilitation programs for patients undergoing orthopedic surgery have been gaining popularity in recent years. However, the current literature has produced varying results. Objective: To evaluate whether prehabilitation is associated with improved preoperative and postoperative outcomes compared with usual care for patients undergoing orthopedic surgery. Data Sources: Bibliographic databases (MEDLINE, CINAHL [Cumulative Index to Nursing and Allied Health Literature], AMED [Allied and Complementary Medicine], Embase, PEDRO [Physiotherapy Evidence Database], and Cochrane Central Register of Controlled Trials) were searched for published trials, and the Institute for Scientific Information Web of Science, System for Information on Grey Literature in Europe, and European clinical trials registry were searched for unpublished trials from January 1, 2000, to June 30, 2022. Study Selection: Randomized clinical trials (RCTs) comparing prehabilitation with standard care for any orthopedic surgical procedure were included. Data Extraction and Synthesis: Two independent reviewers screened trials. Data were pooled using a random-effects model. Recommendations were determined using the Grading of Recommendations Assessment, Development and Evaluation system and the study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline. Main Outcomes and Measures: Pain, function, muscle strength, and health-related quality of life (HRQOL). Results: Forty-eight unique trials involving 3570 unique participants (2196 women [61.5%]; mean [SD] age, 64.1 [9.1] years) were analyzed. Preoperatively, moderate-certainty evidence favoring prehabilitation was reported for patients undergoing total knee replacement (TKR) for function (standardized mean difference [SMD], -0.70 [95% CI, -1.08 to -0.32]) and muscle strength and flexion (SMD, 1.00 [95% CI, 0.23-1.77]) and for patients undergoing total hip replacement (THR) for HRQOL on the 36-item Short Form Health Survey (weighted mean difference [WMD], 7.35 [95% CI, 3.15-11.54]) and muscle strength and abduction (SMD, 1.03 [95% CI, 0.03-2.02]). High-certainty evidence was reported for patients undergoing lumbar surgery for back pain (WMD, -8.20 [95% CI, -8.85 to -7.55]) and moderate-certainty evidence for HRQOL (SMD, 0.46 [95% CI, 0.13-0.78]). Postoperatively, moderate-certainty evidence favoring prehabilitation was reported for function at 6 weeks in patients undergoing TKR (SMD, -0.51 [95% CI, -0.85 to -0.17]) and at 6 months in those undergoing lumbar surgery (SMD, -2.35 [95% CI, -3.92 to -0.79]). Other differences in outcomes favoring prehabilitation were of low to very low quality of evidence. Conclusions and Relevance: In this systematic review and meta-analysis of RCTs, moderate-certainty evidence supported prehabilitation over usual care in improving preoperative function and strength in TKR and HRQOL and muscle strength in THR, high-certainty evidence in reducing back pain, and moderate-certainty evidence in improving HRQOL in lumbar surgery. Postoperatively, moderate-certainty evidence supported prehabilitation for function following TKR at 6 weeks and lumbar surgery at 6 months. Prehabilitation showed promising results for other outcomes, although high risk of bias and heterogeneity affected overall quality of evidence. Additional RCTs with a low risk of bias investigating preoperative and postoperative outcomes for all orthopedic surgical procedures are required.

No evidence exists on outcomes of non-operative management in patients with femoroacetabular impingement and concomitant Tönnis Grade 2 or more hip osteoarthritis: a scoping review.

PURPOSE: The purpose of this scoping review was to assess the outcomes of all the non-operative modalities of management for femoroacetabular impingement (FAI) and concomitant osteoarthritis (OA) Tönnis Grade 2 or more. METHODS: A systematic search of PubMed was performed from inception to December 1st 2021 for literature on outcomes of non-operative management strategies for young adults with symptomatic FAI using the PRISMA Extension for Scoping Reviews guidelines. Cohorts investigating FAI and concomitant hip OA Tönnis Grade 2 or more were considered eligible. Studies not written in English or German, below level 4 evidence, and reviews were excluded. A secondary analysis for FAI without OA stratification was conducted after the initial screening to allow identification of available non-operative interventions. RESULTS: No study reported outcomes separately for non-operative management of FAI with Tönnis Grade 2 OA or more and as such, did not fulfil the inclusion criteria. A secondary analysis included 24 studies that reported on outcomes for non-operative interventions for FAI irrespective of the degree of degeneration. Three studies investigated the efficacy of hyaluronic acid injection, 5 reports investigated corticosteroid injections, 2 studies evaluated the outcomes of hip bracing and 16 studies included a physiotherapy programme. Associations between the aforementioned interventions were analysed. There is level I evidence supporting the efficacy of activity modification and hip-specific physiotherapy for FAI and mild OA. Core-strengthening exercises are prevalent amongst successful regimens in the literature. Contradictory evidence questions the efficacy of hip bracing even for short-term outcomes. Corticosteroid injections have mostly failed in intention-to treat analyses but may be valuable in delaying the need for surgery; further studies are warranted. Reports on outcomes following hyaluronic acid injections are contradictory. CONCLUSION: No evidence exists on outcomes following non-operative management of FAI with concomitant Tönnis Grade 2 or more OA of the hip. Further studies are required and should explore the non-operative interventions that were employed for FAI and milder OA. There is strong evidence for a hip-specific physiotherapy program including activity modification and core strengthening exercises. Adjunct interventions such as corticosteroid injections and NSAID consumption may be valuable in delaying the need for surgery. LEVEL OF EVIDENCE: Level IV.

Validating the Cambridge Protocol: Reliability of Hip Muscle Strength Measurements Using a Motorized Dynamometer and Electromyography.

BACKGROUND: Muscle weakness is common after injury in athletes and in the presence of hip pathology. It will cause abnormal hip biomechanics and can predict future injury. However, objective measurement of hip muscle strength is difficult to perform accurately and reliably. Therefore, it is challenging to determine when an athlete has returned to preinjury levels of strength. In addition, there is currently no standardized method of obtaining measurements, which prevents the data being compared or shared between research centers. PURPOSE: The purpose of this study is to comprehensively assess the inter- and intraobserver reliability of our standardized muscle strength measurement protocol. STUDY DESIGN: Descriptive laboratory study. LEVEL OF EVIDENCE: Level 3, inception cohort study. METHODS: A total of 16 healthy male volunteers (age = 28.3 ± 7.9 years) were recruited. Those with a previous history of hip injuries or disorders were excluded. These volunteers underwent strength testing according to the Cambridge Protocol on 4 separate occasions, performed by 2 independent assessors. Maximal voluntary contractions, fatigue torque fluctuations, and electromyography measurements were recorded. Intra- and interobserver reliability was assessed using intraclass correlation coefficient (ICC). RESULTS: Good-to-excellent correlation was seen for both intra- and interobserver reliability across almost all hip movements for maximal contractions: ICC ranged 0.78 to 0.93 and 0.78 to 0.96, respectively. The standard error of the mean for all hip movements was also extremely low at 2% to 3%. CONCLUSION: The Cambridge Protocol is a highly reliable method for objective measurement of hip muscle strength. We recommend future studies use this protocol, or the principles underpinning it, to enable data sharing and comparison across different studies. CLINICAL RELEVANCE: This is a description and analysis of hip muscle strength measurement. If widely used, it will allow for accurate and objective strength assessment and closer monitoring of hip injuries and pathology.

Inconclusive and Contradictory Evidence for Outcomes After Hip Arthroscopy in Patients With Femoroacetabular Impingement and Osteoarthritis of Tönnis Grade 2 or Greater: A Systematic Review.

PURPOSE: To investigate whether hip arthroscopy (HA) is effective in patients with femoroacetabular impingement and concomitant hip osteoarthritis (OA) of Tönnis grade 2 or greater. METHODS: This review was registered in the International Prospective Register for Systematic Reviews and Meta-analysis (PROSPERO, CRD42020210936). It followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) guidelines and included multiple databases: MEDLINE, Embase, Web of Science Core Collection, and Cochrane Library. All studies in English or German from database inception to December 1, 2020, that investigated outcomes of HA in patients with OA of Tönnis grade 2 or greater were considered eligible. The risk of bias was assessed using the MINORS (Methodological Index for Non-randomized Studies) tool. Data heterogeneity was explored using the I2 test in a random-effects model. RESULTS: Eleven studies met the eligibility criteria. The MINORS (Methodological Index for Non-randomized Studies) score averaged 68% (range, 46%-81%). A total of 616 hips, consisting of 247 hips of interest (Tönnis grade 2 or greater) and 369 controls, were included. The weighted estimated follow-up averaged 29.1 months (range, 12-84 months). Data on patient-reported outcome measures (PROMs) could be extracted for 6 of 11 studies, and date on conversion to total hip arthroplasty were available for 8 of 11. Four studies reported an overall improvement in PROMs after HA, and 2 highlighted a failure of improvement in PROMs. Failure of HA with conversion to total hip arthroplasty was observed at a rate of 0% to 9% in 4 studies, as opposed to proportions as high as 35% to 70% in the other 4 studies. There was a high level of heterogeneity, with a calculated I2 value of 89%. CONCLUSIONS: There is currently contradictory and insufficient evidence regarding the efficacy of HA for hips with femoroacetabular impingement and concomitant OA of Tönnis grade 2 or greater. This is in the context of data with low levels of evidence, mainly consisting of retrospective case series (Level IV) with a high risk of bias and high heterogeneity (I2 of approximately 90%). LEVEL OF EVIDENCE: Level IV, systematic review of Level III and IV studies.

Effectiveness of a treadmill-based aerobic exercise intervention on pain, daily functioning, and quality of life in women with primary dysmenorrhea: A randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness of a treadmill-based aerobic exercise intervention on pain and associated symptoms of primary dysmenorrhea. METHODS: Seventy women with primary dysmenorrhea were included in the study. The experimental group underwent supervised aerobic training for 4 weeks followed by unsupervised home exercise for the next 6 months. The control group continued usual care. The primary outcome was pain. Secondary outcomes included quality of life (QoL), daily functioning, and sleep. RESULTS: After the 4-week training, compared to the control group exercise significantly improved primary outcomes pain quality (mean difference (MD) -1.9, 95% CI 3.8 to -0.04, p < .05), and intensity (MD -4.7, 95% CI -9.3 to -0.09, p < .05), but not present pain. Significant effects were also reported for pain interference (MD -1.7, 95% CI -3.4 to -0.02, p < .05) at 4 weeks; the other outcomes did not significantly differ between groups at this time. During the follow-up period of 7-months, the effect on pain improved to 22 mm (95% CI 18 to 25). Significant benefits of exercise were maintained up to 7-months for present pain, QoL and daily functioning. CONCLUSION: Exercise has significant effects on primary dysmenorrhea-related pain, QoL and function. TRIAL REGISTRATION: ACTRN12613001195741.