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Background: Orthopaedic surgeries include some of the highest volume surgical interventions globally; however, studies have shown that a significant proportion of patients report no clinically meaningful improvement in pain or function after certain procedures. As a result, there is increasing interest in conducting randomised placebo-controlled trials in orthopaedic surgery. However, these frequently fail to reach recruitment targets suggesting a need to improve trial design to encourage participation. The objective of this study was to systematically scope the available evidence on patient and clinician values and preferences which may influence the decision to participate in placebo surgery trial., Methods: A systematic review was conducted via a literature search in the MEDLINE, Embase, PsycInfo, CINAHL, and EconLit databases as of 19 July 2021, for studies of any design (except commentaries or opinion pieces) based on two key concepts: patient and clinician characteristics, values and preferences, and placebo surgery trials., Results: Of 3424 initial articles, we retained 18 eligible studies. Characteristics, preferences, values, and attitudes of patients (including levels of pain/function, risk/benefit perception, and altruism) and of clinicians (including concerns regarding patient deception associated with placebo, and experience/training in research) influenced their decisions to participate in placebo-controlled trials. Furthermore, some aspects of trial design, including randomisation procedures, availability of the procedure outside of the trial, and the information and consent procedures used, also influenced decisions to participate., Conclusion: Participant recruitment is a significant challenge in placebo surgery trials, and individual decisions to participate appear to be sensitive to preferences around treatment. Understanding and quantifying the role patient and clinician preferences may play in surgical trials may contribute to the optimisation of the design and implementation of clinical trials in surgery., (© 2022. The Author(s).)

Background: Approximately 1 in 5 patients feel unsatisfied after total knee arthroplasty (TKA). Prognostic tools may aid in the patient selection process and reduce the proportion of patients who experience unsatisfactory surgery. This study uses the prognostic tool SMART Choice (Patient Prognostic Tool for Total Knee Arthroplasty) to predict patient improvement after TKA. The tool aims to be used by the patient without clinician input and does not require clinical data such as X-ray findings or blood results. The objective of this study is to evaluate the SMART Choice tool on patient decision making, particularly willingness for surgery. We hypothesise that the use of the SMART Choice tool will influence willingness to undergo surgery, especially when used earlier in the patient TKA journey., Methods: This is a multicentred, pragmatic, randomised controlled trial conducted in Melbourne, Australia. Participants will be recruited from the St. Vincent's Hospital, Melbourne (SVHM) Orthopaedic Clinic, and the client base of HCF, Australia (private health insurance company). Patients over 45 years of age who have been diagnosed with knee osteoarthritis and considering TKA are eligible for participation. Participants will be randomised to either use the SMART Choice tool or treatment as usual. The SMART Choice tool provides users with a prediction for improvement or deterioration / no change after surgery based on utility score change calculated from the Veterans-RAND 12 (VR-12) survey. The primary outcome of the study is patient willingness for TKA surgery. The secondary outcomes include evaluating the optimal timing for tool use and using decision quality questionnaires to understand the patient experience when using the tool. Participants will be followed up for 6 months from the time of recruitment., Discussion: The SMART Choice tool has the potential to improve patient decision making for TKA. Although many prognostic tools have been developed for other areas of surgery, most are confined within academic bodies of work. This study will be one of the first to evaluate the impact of a prognostic tool on patient decision making using a prospective clinical trial, an important step in transitioning the tool for use in clinical practice., Trial Registration: Australia and New Zealand Clinical Trials Registry (ANZCTR) - ACTRN12622000072718 . Prospectively registered - 21 January 2022., (© 2022. The Author(s).)

Background: Placebo-controlled surgical trials are recognised as the gold standard way to test the efficacy of a surgical procedure. Despite a rise in arthroscopic subacromial decompression (ASD) surgeries for the treatment of shoulder pain, only two placebo-controlled surgical trials have been conducted. These trials encountered significant recruitment challenges, threatening the external validity of findings. Difficulties with recruitment are common in clinical trials and likely to be amplified in placebo-controlled surgical trials. This mixed method feasibility trial aims to address the following questions: (i) Feasibility: What proportion of patients who have consented to undergo ASD report that they would be willing to enrol in a placebo-controlled trial for this procedure? (ii) Optimisation: Can patients' willingness to enrol in, or understanding of, such a trial be improved by supplementing written consent materials with a brief visual animation that outlines the details of the trial? And (iii) exploration: What factors influence patients stated willingness to enrol in such a trial, and how do they believe the recruitment process could be improved?, Methods: This study aims to recruit 80 patients on the waiting list for ASD. Participants will be randomised (1:1) to either view a brief video animation explaining the hypothetical placebo-controlled trial in addition to written information or to written information only. Participants in both groups will be required to state if they would be willing to opt-in to the hypothetical ASD trial after immediately being presented with the consent material and again 1 week after completion of the consent process. Patients in both groups will also be required to complete a measure of trial literacy. Twenty participants will be purposively sampled to take part in an embedded qualitative study exploring understanding of trial concepts and factors contributing to willingness to opt-in., Discussion: This feasibility study will provide evidence for optimising participant recruitment into a placebo-controlled trial of ASD by consenting patients using animated trial information in addition to written information. This pilot and feasibility data may also be relevant to placebo-controlled surgical trials more broadly, which are characterised by recruitment challenges., Trial Registration: ANZCTR, ACTRN12620001132932 , date October 30, 2020.

Plain English Summary: Involving consumers and community members in the research process is an important step towards developing and delivering effective, person-centered health care. The National Health and Medical Research Council have provided recommendations for involving consumers and community members in research; however, definitive actions to implement these are not well defined.To address this, an established research centre in Melbourne, Australia, has developed a consumer and community involvement framework to incorporate the national recommendations into their research program. This paper describes the framework the research centre has employed, in the hope that other researchers can adapt this approach and learnings to their own research practices.The framework described in this paper aims to foster partnerships between consumers, community members and researchers, and in doing so, encourages consumers to be actively involved in research to help improve future outcomes for those living with musculoskeletal conditions. Simultaneously, the framework encourages researchers to value the consumer voice in their research to ensure they yield meaningful research outcomes for those living with musculoskeletal conditions., Abstract: Background The value of involving consumers and community members in every stage of the research process is gaining recognition as an important consideration in the wider research landscape. The National Health and Medical Research Council (NHMRC) has provided general recommendations for involving consumers and community members in research, although the translation of these recommendations into tangible actions has not yet been well defined. In light of these recommendations, many research institutions are now seeking to incorporate the voices of consumers and community members in their research practices. Methods The consumer and community involvement framework described in this paper incorporates the NHMRC's recommendations to produce a four-tiered model where consumer participants nominate their level of involvement depending on their research interests and preferred level of commitment. In ascending order, the tiers are: Consumer Subscriber, Document Reviewer, Research Buddy and Consumer Advocate.The success of this framework depends upon the implementation of effective governance and access to appropriate infrastructure. A Consumer and Community Advisory Group and a designated Consumer and Community Liaison Officer will take responsibility for ensuring appropriate interactions between consumers, researchers, and the research center's executive team. The framework aims to apply suitable support structures in place to manage expectations and minimize barriers to effective involvement, whilst ensuring that consumer contributions are appropriately valued and incorporated in the research. Discussion Involving consumers and community members in the research process is an important step towards developing and delivering effective, person-centered health care. While consumer and community involvement offer researchers invaluable perspectives on their research program, it provides an opportunity for consumers and community members to be actively involved in health research and improve the health and wellbeing for those living with health conditions., Competing Interests: Competing interestsThe authors declare that they have no competing interests., (© The Author(s) 2020.)

Background: Osteoarthritis is a debilitating condition as well as a growing global health problem, and total knee arthroplasty is an effective treatment for advanced stages of disease. Unplanned 30-day hospital readmission is an indicator of complications, which is a significant financial burden on healthcare systems. The objective is to perform a systematic review of patient-related factors associated with unplanned 30-day readmission following total knee arthroplasty. This information will inform future strategies to improve health outcomes after knee arthroplasty surgery., Methods: MEDLINE and EMBASE will be systematically searched using a comprehensive search strategy. Studies of higher quality than case series will be included, in order to optimise the quality of the findings of this review. We will include studies reporting on patient-related risk factors for unplanned 30-day readmission following primary or revision total knee arthroplasty for any indication. Case series will be excluded, as will studies reporting exclusively on intraoperative, clinician, hospital, and health system risk factors. The reference lists of selected papers will then be screened for any additional literature. Two reviewers will independently apply stringent eligibility criteria to titles, abstracts, and full texts of studies identified in the literature search. They will then extract data from the final list of selected papers according to an agreed-upon taxonomy and vocabulary of the data to be extracted. Assessment of risk of bias and quality of evidence will then take place. Finally, the effect size of each identified risk factor will be determined; meta-analysis will be performed where adequate data is available., Discussion: The findings of this review and subsequent meta-analysis will aid clinicians as they seek to understand the risk factors for 30-day readmission following total knee arthroplasty. Clinicians and patients will be able to use this information to align expectations of the postoperative course, which will enhance the recovery process, and aid in the development of strategies to mitigate identified risks. Another purpose of this review is to assist policy-makers in developing quality indicators for care and provide insights into the drivers of health costs., Systematic Review Registration: PROSPERO CRD42019118154.

Background: A patient- and surgeon-Delphi-derived Outcome Measures in Rheumatology (OMERACT) draft core domain set for total joint arthroplasty (TJR) trials was recently developed. Our objective was to obtain further patient stakeholder endorsement of draft core domain set for TJR clinical trials., Methods: We surveyed two patient groups: (1) OMERACT patient partners; and (2) patients who had undergone hip or knee TJR. Patients received an introductory email with explanations about the core domain set and instructions to rate the core domains, i.e., important aspects, of OMERACT TJR clinical trial draft core domain set. Rating was on a nominal scale, where 1-3 indicated a domain of limited importance, 4-6 an important, but not critical domain, and 7-9 a critical domain. We used Mann-Whitney test (a non-parametric test) to compare the distribution of ratings between the two groups., Results: Thirty one survey participants from the OMERACT patient partner group and 118 knee/hip TJR patients responded with response rates of 66 and 80%, respectively. Majority of the survey respondents were female, 87 vs. 53%, and were 55 years or older, 57 vs. 94%. Median (interquartile range [IQR]) scores for six core domains by OMERACT and knee/hip TJR patient groups were, respectively: pain, 8 [8, 9] and 9 [8, 9]; function, 9 [8, 9] and 9 [8, 9]; patient satisfaction, 8 [8, 9] and 8 [7, 9]; revision surgery, 7 [7, 8] and 7 [5, 9]; adverse events, 8 [7, 9] and 8 [6, 9]; and death, 9 [6, 9] and 9 [4, 9]. No statistically significant differences in rating were noted for any of the six core domains between the two groups (p ≥ 0.31). Among the additional domains, ratings for patient participation did not differ by group (p = 0.98), but ratings for cost were significantly different (p = 0.005). Patients provided qualitative feedback regarding core domains, and did not propose any modifications to the draft core domain set., Conclusions: Two separate patient stakeholder groups endorsed the OMERACT TJR draft core domain set for TJR trials.