Predictive Tool Use and Willingness for Surgery in Patients With Knee Osteoarthritis: A Randomized Clinical Trial.

Importance: Despite the increasing number of tools available to predict the outcomes of total knee arthroplasty (TKA), the effect of these predictive tools on patient decision-making remains uncertain. Objective: To assess the effect of an online predictive tool on patient-reported willingness to undergo TKA. Design, Setting, and Participants: This parallel, double-masked, 2-arm randomized clinical trial compared predictive tool use with treatment as usual (TAU). The study was conducted between June 30, 2022, and July 31, 2023. Participants were followed up for 6 months after enrollment. Participants were recruited from a major Australian private health insurance company and from the surgical waiting list for publicly funded TKA at a tertiary hospital. Eligible participants had unilateral knee osteoarthritis, were contemplating TKA, and had previously tried nonsurgical interventions, such as lifestyle modifications, physiotherapy, and pain medications. Intervention: The intervention group was provided access to an online predictive tool at the beginning of the study. This tool offered information regarding the likelihood of improvement in quality of life if patients chose to undergo TKA. The predictions were based on the patient's age, sex, and baseline symptoms. Conversely, the control group received TAU without access to the predictive tool. Main Outcomes and Measures: The primary outcome measure was the reduction in participants' willingness to undergo surgery at 6 months after tool use as measured by binomial logistic regression. Secondary outcome measures included participant treatment preference and the quality of their decision-making process as measured by the Knee Decision Quality Instrument. Results: Of 211 randomized participants (mean [SD] age, 65.8 [8.3] years; 118 female [55.9%]), 105 were allocated to the predictive tool group and 106 to the TAU group. After adjusting for baseline differences in willingness for surgery, the predictive tool did not significantly reduce the primary outcome of willingness for surgery at 6 months (adjusted odds ratio, 0.85; 95% CI, 0.42-1.71; P = .64). Conclusions and Relevance: Despite the absence of treatment effect on willingness for TKA, predictive tools might still enhance health outcomes of patients with knee osteoarthritis. Additional research is needed to optimize the design and implementation of predictive tools, address limitations, and fully understand their effect on the decision-making process in TKA. Trial Registration: ANZCTR.org.au Identifier: ACTRN12622000072718.

Patients' Views on AI for Risk Prediction in Shared Decision-Making for Knee Replacement Surgery: Qualitative Interview Study.

BACKGROUND: The use of artificial intelligence (AI) in decision-making around knee replacement surgery is increasing, and this technology holds promise to improve the prediction of patient outcomes. Ambiguity surrounds the definition of AI, and there are mixed views on its application in clinical settings. OBJECTIVE: In this study, we aimed to explore the understanding and attitudes of patients who underwent knee replacement surgery regarding AI in the context of risk prediction for shared clinical decision-making. METHODS: This qualitative study involved patients who underwent knee replacement surgery at a tertiary referral center for joint replacement surgery. The participants were selected based on their age and sex. Semistructured interviews explored the participants' understanding of AI and their opinions on its use in shared clinical decision-making. Data collection and reflexive thematic analyses were conducted concurrently. Recruitment continued until thematic saturation was achieved. RESULTS: Thematic saturation was achieved with 19 interviews and confirmed with 1 additional interview, resulting in 20 participants being interviewed (female participants: n=11, 55%; male participants: n=9, 45%; median age: 66 years). A total of 11 (55%) participants had a substantial postoperative complication. Three themes captured the participants' understanding of AI and their perceptions of its use in shared clinical decision-making. The theme Expectations captured the participants' views of themselves as individuals with the right to self-determination as they sought therapeutic solutions tailored to their circumstances, needs, and desires, including whether to use AI at all. The theme Empowerment highlighted the potential of AI to enable patients to develop realistic expectations and equip them with personalized risk information to discuss in shared decision-making conversations with the surgeon. The theme Partnership captured the importance of symbiosis between AI and clinicians because AI has varied levels of interpretability and understanding of human emotions and empathy. CONCLUSIONS: Patients who underwent knee replacement surgery in this study had varied levels of familiarity with AI and diverse conceptualizations of its definitions and capabilities. Educating patients about AI through nontechnical explanations and illustrative scenarios could help inform their decision to use it for risk prediction in the shared decision-making process with their surgeon. These findings could be used in the process of developing a questionnaire to ascertain the views of patients undergoing knee replacement surgery on the acceptability of AI in shared clinical decision-making. Future work could investigate the accuracy of this patient group's understanding of AI, beyond their familiarity with it, and how this influences their acceptance of its use. Surgeons may play a key role in finding a place for AI in the clinical setting as the uptake of this technology in health care continues to grow.

Process of change for people with knee osteoarthritis undergoing cognitive functional therapy: a replicated single-case experimental design study.

PURPOSE: To examine the applicability and process of change of Cognitive Functional Therapy (CFT) in the management of pain and disability in people with knee osteoarthritis who were offered knee replacement surgery and had risk factors for poor response to surgery. METHODS: Single-case experimental design with a mixed-methods, repeated measures approach was used to investigate the process of change through CFT in four participants. Qualitative interviews investigated beliefs, behaviours and coping responses, and self-reported measures assessed pain, disability, psychological factors, and function at 25 timepoints. Study registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12619001491156). RESULTS: Qualitative data indicate that CFT promoted helpful changes in all participants, with two responses observed. One reflected a clear shift to a biopsychosocial conceptualisation of osteoarthritis, behavioural re-engagement and the view that a knee replacement was no longer necessary. The other response reflected a mixed conceptualisation with dissonant beliefs about osteoarthritis and its management. Psychological and social factors were identified as potential treatment barriers. Overall, quantitative measures supported the qualitative findings. CONCLUSION: The process of change varies between and within individuals over time. Psychological and social barriers to treatment have implications for future intervention studies for the management of knee osteoarthritis.IMPLICATIONS FOR REHABILITATIONCognitive Functional Therapy is applicable in the management of knee osteoarthritis.Reconceptualisation of osteoarthritis reflected a helpful change.Psychological and social factors emerged as barriers to recovery.

Research Buddy partnership in a MD-PhD program: lessons learned.

BACKGROUND AND AIMS: There is increasing recognition of the importance of patient involvement in research. In recent years, there has also been growing interest in patient partnerships with doctoral studies students. However, it can be difficult to know where to start and how to go about such involvement activities. The purpose of this perspective piece was to share experiential insight of the experience of a patient involvement program such that others can learn from this experience. BODY: This is a co-authored perspective piece centred on the experience of MGH, a patient who has had hip replacement surgery, and DG, a medical student completing a PhD, participating in a Research Buddy partnership over the course of over 3 years. The context in which this partnership took place was also described to facilitate comparison with readers' own circumstances and contexts. DG and MGH met regularly to discuss, and work together on, various aspects of DG's PhD research project. Reflexive thematic analysis was conducted on reflections from DG and MGH regarding their experience in the Research Buddy program to synthesise nine lessons which were then corroborated with reference to published literature on patient involvement in research. These lessons were: learn from experience; tailor the program; get involved early; embrace uniqueness; meet regularly; build rapport; ensure mutual benefit; broad involvement; regularly reflect and review. CONCLUSIONS: In this perspective piece, a patient and a medical student completing a PhD reflected upon their experience co-designing a Research Buddy partnership within a patient involvement program. A series of nine lessons was identified and presented to inform readers seeking to develop or enhance their own patient involvement programs. Researcher-patient rapport is foundational to all other aspects of the patient's involvement.

The importance of patient involvement in research is gaining recognition. Existing research centres, as well as those that are just getting started, need to find their own way to involve patients and community members. However, learning from the experience of others is crucial to ensure every effort is made to do this in a fruitful way. Therefore, we aimed to share our experience and provide a list of lessons learned to help other researchers and patients get started and work together effectively. Our research centre developed a framework for involving patients in joint replacement research. Part of this framework is a 'Research Buddy' program, where a research student partners with a patient so that the research they conduct is more relevant and applicable to the target population. In our case, the research student partnered with someone who had a hip replacement to develop and test a questionnaire for an interview study about artificial intelligence in shared decision-making. The student and patient worked together and wrote this perspective piece outlining nine lessons so readers can learn from their experience of this program. The lessons were: learn from experience, tailor the program, get involved early, embrace uniqueness, meet regularly, build rapport, ensure mutual benefit, broad involvement, regularly reflect and review. People interested in starting, or improving, their own patient involvement activities can learn from our experience. These lessons will need to be adapted to fit the purpose and unique situation of other researchers and patients who have different needs and circumstances.

Analysis of Rates of Completion, Delays, and Participant Recruitment in Randomized Clinical Trials in Surgery.

Importance: Discontinuation and nonpublication are established sources of avoidable waste among surgical trials, but rates of delayed completion and recruiting shortfalls remain unclear. Objectives: To examine the rate of delayed completion, incomplete enrollment, and discontinuation among randomized clinical trials in surgical populations and the duration of delays and extent of recruiting shortfalls among these trials. Design, Setting, and Participants: This cross-sectional study examined randomized clinical trials in surgical populations registered on ClinicalTrials.gov between January 1, 2010, and December 31, 2014. Analysis was conducted between October 27, 2021, and June 30, 2022. Main Outcomes and Measures: The main outcomes were the percentages of trials completed on time or with full enrollment. Delays and recruiting shortfalls were identified by comparing projected enrollment and study timeframes prespecified at the time of registration with the actual study duration and enrollment reported on completion or discontinuation. Absolute and relative differences between planned and actual trial conduct were presented for discontinued trials and those completed with delays or recruiting shortfalls. Results: In total, 2542 randomized clinical trials in surgical populations were included in the study sample, of which 370 (14.6%; 95% CI, 13.2%-15.9%) were completed both on time and with full enrollment. Approximately 1 in 5 trials (20.4%; 95% CI, 18.9%-22.0%) were completed within their planned timeframe, and 1166 trials (45.9%; 95% CI, 43.9%-47.8%) met their prespecified enrollment target. The median delay among completed trials was 12.2 months (IQR, 5.1-24.3 months) or 66.7% (IQR, 30.1%-135.8%) longer than planned. Among completed trials that did not meet their prespecified enrollment target, the median recruiting shortfall was equivalent to 31.0% (IQR, 12.7%-55.5%) of the planned study sample. A total of 546 trials (21.5%; 95% CI, 19.9%-23.1%) were discontinued. The median time to discontinuation was 26.4 months (IQR, 15.2-45.7 months), and the median recruiting shortfall among discontinued trials was equivalent to 92.7% (IQR, 65.0%-100.0%) of the trial's prespecified enrollment target. Conclusions and Relevance: This cross-sectional study found that delayed completion, recruiting shortfalls, and untimely discontinuation were common among surgical trials. These findings highlight the importance of ensuring that investigators and funders do not overestimate the feasibility of planned trials.

An Economic Model for Estimating Trial Costs with an Application to Placebo Surgery Trials.

BACKGROUND AND OBJECTIVE: Waste in clinical trials remains rife. We developed an economic model to predict the cost of trials based on input costs, duration, power, number of sites, recruitment eligibility and consenting rates. METHODS: We parameterised the model for three proxy placebo-controlled surgical trials using data from a systematic review, a bespoke cost survey, and from the literature. We used the model to compare target and actual trial performance for (i) a trial that was completed on time but with more sites, (ii) a trial that completed after a time extension, and (iii) an incomplete trial. RESULTS: Successful trials more accurately anticipated the true recruitment rate that they achieved and those that overestimated this were most likely to fail. The costs of overestimating recruitment rates were dramatic: all proxy trials had significantly higher costs than planned, with additional funding of at least AUD$600,000 (50% above budget) required for trials that completed after adding more sites or more time, and over AUD$2 million (260% above budget) for incomplete trials. CONCLUSIONS: This model shows the trade-offs between time and cost, or both, when recruitment is lower than anticipated. Greater consideration is needed to improve trial planning, reviewing, and funding of these trials to avoid costly overruns and incomplete trials.

Peoples' beliefs about their chronic hip pain and its care: a systematic review of qualitative studies. "I'm just getting old and breaking down".

ABSTRACT: To enhance patient-centred care of people with hip pain, we need a comprehensive understanding of peoples' beliefs about their hip pain. This systematic review explored the beliefs and expectations of middle-aged and older adults about chronic hip pain and its care across different healthcare settings and contexts. This review was a synthesis of qualitative studies using a framework synthesis approach. We searched 5 databases: MEDLINE, CINAHL, The Cochrane Central Register of Controlled Trials, EMBASE, and PsycINFO. Two reviewers independently screened the studies for eligibility. We included qualitative studies that included people with a mean age of older than 45 years and 80% or more of the participants had chronic hip pain, or if they reported the data about participants with chronic hip pain who were 45 years or older separately. We excluded studies of people with systemic conditions and studies not published in English. We included 28 studies involving 352 participants with chronic hip pain. We generated 5 themes: (1) biomedical causes (subtheme 1: scary pathoanatomical labels, subtheme 2: information needs); (2) negative impacts on physical, social, and mental health; (3) activity avoidance or modification and rest; (4) treatment failures (subtheme: information and support were helpful); (5) surgery is inevitable. Middle-aged and older adults labelled their hip joint damaged and attributed their hip pain to age, and wear and tear. People coped with their hip pain by avoiding or modifying activity. People were not educated about treatments or used treatments that failed to improve their hip pain. People believed that surgery for their hip was inevitable.

Total joint replacement may be a valuable treatment for Aboriginal and Torres Strait Islander people with osteoarthritis, but uptake is low.

BACKGROUND: Despite bearing a higher burden of osteoarthritis, little research has examined disparities in the access, utilisation and surgical outcomes associated with total joint replacement (TJR) among Aboriginal and Torres Strait Islander people. METHODS: We conducted a retrospective cohort study to compare the sociodemographic and clinical characteristics of all Aboriginal and Torres Strait Islander and non-Aboriginal patients who underwent primary hip and knee replacement at St Vincent's Hospital Melbourne between 1996 and 2019. RESULTS: A total of 10 277 primary total knee or hip replacements were performed in the 1996-2019 study period, of which 49 (0.5%) patients identified as either Aboriginal and/or Torres Strait Islander. Aboriginal and Torres Strait Islander patients were younger (61.7 ± 11.8 vs. 68.3 ± 10.3 years; P < 0.001), recorded higher Body Mass Index scores (median (IQR), 36.0 (29.5-41.4) vs. 30.8 (27.0-35.3); P < 0.001) and were more likely to experience multiple co-morbidities at the time of surgery. Despite these findings, Aboriginal and Torres Strait Islander patients did not experience higher complication rates and experienced comparable, clinically meaningful quality of life improvements 12-months post-surgery. CONCLUSIONS: TJR appears to be a valuable treatment option for Aboriginal and Torres Strait Islander people with end-stage osteoarthritis. Our study was limited by the small number of procedures conducted in patients who identify as Aboriginal and Torres Strait Islander. Further research is needed to understand why uptake of TJR by Aboriginal and Torres Strait Islander people is low.

The role of digital health interventions to improve health literacy in surgical patients: a narrative review in arthroplasty.

BACKGROUND: Arthroplasty is a high-volume but costly treatment option for advanced osteoarthritis. Health literacy and patient education are modifiable factors that can improve patient outcomes in arthroplasty. Digital technologies show potential as an instrument for providing patients with reliable information. This narrative review aimed to identify the current evidence for how effective digital health interventions (DHIs) are in targeting health literacy and related constructs (including knowledge, decision-making and self-efficacy) in arthroplasty. METHODS: Six databases were searched for published studies comprising health literacy and related constructs, arthroplasty, and DHIs. The main outcome measure was health literacy. Two reviewer-authors independently screened studies according to predefined inclusion criteria and performed data extraction. Data was analysed and summarized in tabular and narrative form. RESULTS: Two thousand seven-hundred and sixty-four titles and abstracts were screened. One hundred and sixty-seven papers underwent full-text analysis. No studies used health literacy as an outcome measure; therefore, the outcome measure was broadened to include its constructs, and the full-text analysis was repeated. Thirteen studies were included. No study following a structured design for their DHI. Eleven studies demonstrated participant improvement in constructs of health literacy, including knowledge, decision-making and self-management. CONCLUSION: Current evidence suggests digital technology may provide new means of educating patients and improving aspects of their health literacy. More research digital technology with a structured approach, framework and standardized measures is required. Well-designed digital technology may become a useful adjunct to future patient care.

Patient and clinician characteristics and preferences for increasing participation in placebo surgery trials: a scoping review of attributes to inform a discrete choice experiment.

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.

Evaluating willingness for surgery using the SMART Choice (Knee) patient prognostic tool for total knee arthroplasty: study protocol for a pragmatic randomised controlled trial.

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.

How do middle-aged and older adults with chronic hip pain view their health problem and its care? A protocol for a systematic review and qualitative evidence synthesis.

INTRODUCTION: Chronic hip pain in middle-aged and older adults is common and disabling. Patient-centred care of chronic hip pain requires a comprehensive understanding of how people with chronic hip pain view their health problem and its care. This paper outlines a protocol to synthesise qualitative evidence of middle-aged and older adults' views, beliefs, expectations and preferences about their chronic hip pain and its care. METHODS AND ANALYSIS: We will perform a qualitative evidence synthesis using a framework approach. We will conduct this study in accord with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement and the Enhancing Transparency in Reporting the synthesis of Qualitative research checklist. We will search MEDLINE, CINAHL, The Cochrane Central Register of Controlled Trials, EMBASE and PsycINFO using a comprehensive search strategy. A priori selection criteria include qualitative studies involving samples with a mean age over 45 and where 80% or more have chronic hip pain. Two or more reviewers will independently screen studies for eligibility, assess methodological strengths and limitations using the Critical Appraisal Skills Programme qualitative studies checklist, perform data extraction and synthesis and determine ratings of confidence in each review finding using the Grading of Recommendations Assessment, Development and Evaluation-Confidence in the Evidence from Reviews of Qualitative research approach. Data extraction and synthesis will be guided by the Common-Sense Model of Self-Regulation. All authors will contribute to interpreting, refining and finalising review findings. This protocol is registered on PROSPERO and reported according to the PRISMA Statement for Protocols (PRISMA-P) checklist. ETHICS AND DISSEMINATION: Ethics approval is not required for this systematic review as primary data will not be collected. The findings of the review will be disseminated through publication in an academic journal and scientific conferences. PROSPERO REGISTRATION NUMBER: PROSPERO registration number: CRD42021246305.

Life or limb: an international qualitative study on decision making in sarcoma surgery during the COVID-19 pandemic.

OBJECTIVES: The COVID-19 pandemic is unprecedented as a global crisis over the last century. How do specialist surgeons make decisions about patient care in these unprecedent times? DESIGN: Between April and May 2020, we conducted an international qualitative study. Sarcoma surgeons from diverse global settings participated in 60 min interviews exploring surgical decision making during COVID-19. Interview data were analysed using an inductive thematic analysis approach. SETTING: Participants represented public and private hospitals in 14 countries, in different phases of the first wave of the pandemic: Australia, Argentina, Canada, India, Italy, Japan, Nigeria, Singapore, Spain, South Africa, Switzerland, Turkey, UK and USA. PARTICIPANTS: From 22 invited sarcoma surgeons, 18 surgeons participated. Participants had an average of 19 years experience as a sarcoma surgeon. RESULTS: 17/18 participants described a decision they had made about patient care since the start of the pandemic that was unique to them, that is, without precedence. Common to 'unique' decisions about patient care was uncertainty about what was going on and what would happen in the future (theme 1: the context of uncertainty), the impact of the pandemic on resources or threat of the pandemic to overwhelm resources (theme 2: limited resources), perceived increased risk to self (theme 3: duty of care) and least-worst decision making, in which none of the options were perceived as ideal and participants settled on the least-worst option at that point in time (theme 4: least-worst decision making). CONCLUSIONS: In the context of rapidly changing standards of justice and beneficence in patient care, traditional decision-making frameworks may no longer apply. Based on the experiences of surgeons in this study, we describe a framework of least-worst decision making. This framework gives rise to actionable strategies that can support decision making in sarcoma and other specialised fields of surgery, both during the current crisis and beyond.

Gamifying health literacy: how can digital technology optimize patient outcomes in surgery?

The digital age is entrenched in our society, with constant innovation driving change in the way clinicians and patients manage their health concerns. Health literacy is emerging as an important modifiable factor that can affect clinical and patient outcomes, yet traditional forms of patient education have shown mixed results. Digital media and technologies, the concept of gamification as a means to improve patient health literacy, and its potential for misuse will be explored in this review, in the context of a digital, gamified tool that could support patients along their surgical journey.

The effect of animated consent material on participants' willingness to enrol in a placebo-controlled surgical trial: a protocol for a randomised feasibility study.

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.

Addressing surgical inequity for Aboriginal and Torres Strait Islander people in Australia's universal health care system: a call to action.

Aboriginal and Torres Strait Islander people continue to experience health inequity within the Australian health care system. Little research has examined how disparities in surgical care access and outcomes contribute to Aboriginal health. In this narrative review and call to action, we discuss five care points along the journey to high-quality surgical care: health care seeking, primary health care services, specialist services, surgery and surgical outcomes. We highlight barriers and disparities that exist along this journey, drawing examples from the field of joint replacement surgery. Finally, we present opportunities for change at the health system, health service and clinician level, calling upon researchers, clinicians and policy makers to confront the surgical disparities experienced by Aboriginal and Torres Strait Islander people.

Factors Underlying Patient and Surgeon Willingness to Participate in a Placebo Surgery Controlled trial: A Qualitative Investigation.

Objective: To investigate the factors underlying willingness to participate in a hypothetical trial among patients and surgeons, to inform the design of future placebo surgery controlled trials. Background: Placebo surgery controlled trials are the gold standard for testing the efficacy of surgical procedures. However, these trials commonly fail to meet the target sample size and terminate underpowered. Methods: From October 2019 to July 2020, eligible patients were identified from the orthopedic waiting list at a single tertiary hospital and surgeons were identified from orthopedic clinics at three tertiary hospitals in Australia. Qualitative interviews explored factors underlying willingness to participate in a hypothetical trial, including understanding of trial concepts; attitudes; and trial design preferences. Data collection and analysis were conducted in parallel. Recruitment ceased when no new concepts emerged. Interview data were analyzed using reflexive thematic analysis. Results: The majority of surgeons and only a few patients indicated a willingness to participate in a placebo surgery controlled trial. Factors underlying willingness were captured in four themes: (1) Understanding and attitudes toward placebo; (2) Attitudes towards randomization/perception of equipoise; (3) Perception of risk; and (4) Ethical concerns. Conclusions: To optimize recruitment in the future, trialists may consider embedding strategies into the recruitment process that validate patients' symptoms, encourage an altruistic mindset, address surgeon biases, and involve surgeons in explaining trial concepts to patients. Trialists may also consider designing three arm trials that meet surgeons' preferences for a "low" and "high" fidelity placebo.

Placebo Surgery Controlled Trials: Do They Achieve What They Set Out To Do? A Systematic Review.

OBJECTIVE: To explore whether placebo surgery controlled trials achieve what they set out to do by investigating discrepancy between projected and actual design aspects of trials identified through systematic review methods. SUMMARY BACKGROUND: Interest in placebo surgery controlled trials is growing in response to concerns regarding unnecessary surgery and the societal cost of low-value healthcare. As questions about the justifiability of using placebo controls in surgery have been addressed, attention is now being paid to more practical concerns. METHODS: Six databases were searched from inception - May 2020 (MEDLINE, Embase, Emcare, APA PsycInfo, CINAHL, Cochrane Library). Placebo surgery controlled trials with a published protocol were included. Three authors extracted "projected" design aspects from protocols and "actual" design aspects from main findings papers. Absolute and relative difference between projected and actual design aspects were presented for each trial. Trials were grouped according to whether they met their target sample size ("completed") and were concluded in a timely fashion. Pairs of authors assessed risk of bias. RESULTS: Of 24 trials with data available to analyse; 3 were completed and concluded within target timeframe; 10 were completed and concluded outside the target timeline; 4 were completed without clear target timeframes; 2 were incomplete and concluded within the target framework; 5 were incomplete and concluded outside the target timeline. Trials which reached the recruitment target underestimated trial duration by 88% and number of recruitment sites by 87%. CONCLUSIONS: Trialists need to factor additional time and sites into future placebo surgery controlled trials. A robust reporting framework of projected and actual trial design is imperative for trialists to learn from their predecessors. REVIEW REGISTRATION: PROSPERO (CRD42019133296).

Arthroplasty information on the internet: quality or quantity?

AIMS: Total joint replacement (TJR) is a high-cost, high-volume procedure that impacts patients' quality of life. Informed decisions are important for patients facing TJR. The quality of information provided by websites regarding TJR is highly variable. We aimed to measure the quality of TJR information online. METHODS: We identified 10,800 websites using 18 TJR-related keywords (conditions and procedures) across the Australian, French, German and Spanish Google search engines. We used the Health on the Net (HON) toolbar to evaluate the first 150 websites downloaded for every keyword in each language. The quality of information on websites was inspected, accounting for differences by language and tertiles. We also undertook an analysis of English websites to explore types of website providers. RESULTS: 'Total joint replacement' had the most results returned (150 million websites), and 9% of websites are HON-accredited. Differences in information quality were seen across search terms (p < 0.001) and tertiles (p < 0.001), but not between languages (p = 0.226). A larger proportion of HON-accredited websites were seen from keywords in the condition and arthroplasty categories. The first tertile contained the highest number of HON-accredited websites for the majority of search terms. Government/educational bodies sponsored the majority of websites. CONCLUSION: Clinicians must consider the shortage of websites providing validated information, with disparities in both number and quality of websites for TJR conditions and procedures. As such, the challenge for clinicians is to lead the design of reliable, accurate and ethical orthopaedic websites online and direct patients to them. This stands to reward both parties greatly.

What Influences Patient Satisfaction after TKA? A Qualitative Investigation.

BACKGROUND: Patient satisfaction is a common measure of the success of an orthopaedic intervention. However, there is poor understanding of what satisfaction means to patients or what influences it. QUESTIONS/PURPOSES: Using qualitative study methodology in patients undergoing TKA, we asked: (1) What does it mean to be satisfied after TKA? (2) What factors influence satisfaction levels after TKA? METHODS: People in a hospital registry who had completed 12-month follow-up questionnaires and were not more than 18 months post-TKA at the time of sampling were eligible (n = 121). To recruit a sample that provided insight into a range of TKA experiences, we divided eligible candidates on the registry into quadrants based on their responder status and satisfaction level. A responder was an individual who experienced a clinically meaningful change in pain and/or function on the WOMAC according to the Outcome Measures in Rheumatology-Osteoarthritis Research Society International (OMERACT-OARSI) responder criteria. Individuals were considered satisfied unless they indicated somewhat dissatisfied or very dissatisfied for one or more of the four items on the Self-Administered Patient Satisfaction Scale. From the resulting quadrants: responder satisfied, nonresponder satisfied, nonresponder dissatisfied, responder dissatisfied, we identified men and women with a range of ages and invited them to participate (n = 85). The final sample (n = 40), consisted of 10 responder satisfied, nine nonresponder satisfied, eight nonresponder dissatisfied, and 13 responder dissatisfied; 71% were women, with a mean age of 71 ± 7 years and a mean time since TKA surgery of 17 ± 2 months (range 13 to 25 months). Interview transcripts were analyzed by looking for factors in the participants' narrative that appeared to underscore their level of satisfaction and attaching inductive (data-derived, rather than a priori derived) codes to relevant sections of text. Coded data from participants who reported high and low levels of satisfaction were compared/contrasted and emerging patterns were mapped into a conceptual model. Recruitment continued until no new information was uncovered in data analysis of subsequent interviews, signalling to the researchers that further interviews would not change the key themes identified and data collection could cease. RESULTS: In those with high satisfaction levels, satisfaction was conceptualized as an improvement in pain and function. In those with low satisfaction levels, rather than an improvement, satisfaction was conceptualized as completely resolving all symptoms and functional limitations. In addition, we identified three pathways through which participants reached different levels of low and high satisfaction: (1) The full-glass pathway, characterized by no or minimal ongoing symptoms and functional deficits, which consistently led to high levels of satisfaction; (2) the glass-half-full pathway, characterized by ongoing symptoms and functional limitations, which led to high satisfaction; and (3) the glass-half-empty pathway, also characterized by ongoing symptoms and functional limitations, which led to low satisfaction levels. The latter two pathways were mediated by three core mechanisms (recalibration, reframing valued activities, and reconceptualization) influenced either positively or negatively by (1) a persons' thoughts and feelings such as optimism, self-efficacy, pain catastrophizing, external locus of control; and (2) social and contextual factors such as fulfilment of social roles, therapeutic alliance, lack of family/social support. CONCLUSIONS: This qualitative study suggests that for preoperative patients in whom unrealistically high hopes for complete symptom resolution and restoration of functional capacity persists, it may be appropriate to direct them away from TKA due to the risk of low satisfaction. For postoperative patients troubled by ongoing symptoms or functional limitations, clinicians may improve levels of satisfaction by targeting the three core mechanisms (recalibration, reframing valued activities, and reconceptualization) through addressing modifiable negative thoughts and feelings in interventions such as psychology or psychotherapy; and negative social and contextual factors by promoting a strong therapeutic alliance and engagement in community activities. Given that these factors may be identifiable preoperatively, future research is needed to explore if and how addressing them preoperatively may improve satisfaction post-TKA. LEVEL OF EVIDENCE: Level IV, therapeutic study.