Visual narratives in medicine - Bridging the gap in graphic medicine with an illustrated narrative of osteoarthritis.

Objective: Visual narratives have been used in medicine to share information in the form of stories with the potential to improve understanding of conditions and change behaviours. One genre of visual narratives is "graphic medicine", which integrates comics into medical education and the delivery of healthcare. Graphic medicine can maximise the impact of research findings by presenting them in a more accessible format, which may be particularly useful in certain populations, such as those with low levels of health literacy. Those with lower health literacy levels and osteoarthritis (OA) are less likely to manage their condition with guideline recommended management strategies, experience a higher burden of disease, and have lower access to care. Our objectives were to review the current visual narratives in the field of and create a graphic medicine visual narrative based on existing research. Design: This paper summarises the current visual narratives in OA and presents a graphic medicine visual narrative to illustrate the experience of living with OA. Considerations for the dissemination of visual narratives to target audiences are also discussed. Results: The most common visual narratives in are infographics, videos, and graphic medicine. A graphic medicine visual narrative, based on previous qualitative work and informed by a framework, was created to illustrate two distinct narratives - impairment and participatory. Conclusion: Visual narratives remain an emerging field in OA but may serve as a useful resource for patients or clinicians to discuss various aspects of OA management. Future research should evaluate and validate the use of visual narratives in OA.

Influences on clinical trial participation: Enhancing recruitment through a gender lens - A scoping review.

Background: Suboptimal clinical trial recruitment contributes to research waste. Evidence suggests there may be gender-based differences in willingness to participate in clinical research. Identifying gender-based differences impacting the willingness of trial participation may assist trial recruitment. Objectives: To examine factors that influence the willingness of men and women to participate in clinical trials and to identify modifiable factors that may be targeted to optimise trial participation. Material and methods: Electronic databases were searched with key words relating to 'gender', 'willingness to participate' and 'trial'. Included studies were English language and reported gender-based differences in willingness to participate in clinical trials, or factors that influence a single gender to participate in clinical trials. Studies were excluded if they described the demographic factors of trial participants or if the majority of participants were pregnant. Extracted data were coded, categorized, analysed thematically and interpreted using Arksey and O'Malley's framework. Results: Sixty-three studies were included. Two main themes were identified: trial characteristics and participant characteristics. A number of gender-based differences moderating willingness to participate were observed although only one, 'concern for self' was found to influence actual trial participation rates between genders. Conclusion: The relationship between factors influencing willingness to participate in clinical trials is complex. The influence of gender on willingness to participate, while important, may be moderated by other factors including socioeconomic status, ethnicity and health condition. Exploring factors that influence willingness to participate specific to a study cohort likely offers the most promise to optimise trial recruitment of that cohort.

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.

Trauma-informed physiotherapy and the principles of safety, trustworthiness, choice, collaboration, and empowerment: a qualitative study.

INTRODUCTION: Trauma is common and may lead to lasting adverse effects on health. Trauma-informed practice does not treat trauma but uses a strengths-based approach to encourage engagement in services. OBJECTIVE: To understand how physiotherapy attends to trauma-informed principles. METHODS: This qualitative ethnographic study was set in an Australian hospital. Three data collection methods were used, including observations of clinical practice, interactive reflexive group discussions with physiotherapists, and interviews with patients. Data analysis included an initial inductive phase followed by thematic mapping to trauma-informed principles. Critical reflexivity was used throughout to examine how the authors' perspectives and assumptions affected the analysis. RESULTS: Twelve observations of consultations, ten interviews with people receiving physiotherapy, and five group discussions with physiotherapists were conducted. Themes produced within each of five principles of trauma-informed care included: Safety: not just a number, uncertainty beyond managing physical risks, upbeat approach as default needs balance, pragmatic environments inadequate; Trustworthiness: touch needs further consideration, assumed consent; Choice: limited options; Collaboration: let's do it together, variable consideration of the patient as expert, task focus, pushing the "right" treatment, missing insight into power imbalance; Empowerment: extending function and independence, building nonphysical skills but lack of clarity. CONCLUSION: Physiotherapy incorporates crucial aspects of trauma-informed care, but opportunities exist to enhance physiotherapists' skills and knowledge, particularly in relation to non-physical safety considerations.

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.

Broken Machines or Active Bodies? Part 2. How People Talk About Osteoarthritis and Why Clinicians Need to Change the Conversation.

SYNOPSIS: How people talk about osteoarthritis may impact outcomes, including uptake of guideline recommendations related to activity-based lifestyles and interventions. In this editorial, we describe 2 key ways of talking, based on findings from our systematic review of 62 qualitative studies exploring the perceptions of people with knee osteoarthritis (n = 1208), their carers (n = 28), and clinicians (n = 2403). Among raw quotes extracted from the studies, we observed a dominant impairment-based way of talking and a participatory based way of talking. These ways of talking form a novel framework to help clinicians understand what people think and do about osteoarthritis. J Orthop Sports Phys Ther 2023;53(6):325-330. doi:10.2519/jospt.2023.11880.

Physical activity amongst culturally and linguistically diverse communities in Australia: a scoping review.

BACKGROUND: Australia's overseas-born population continues to grow. This population is disproportionately affected by chronic, non-communicable diseases. Physical activity is the cornerstone of all chronic disease management. Engaging people from culturally and linguistically diverse (CALD) backgrounds in physical activity is an important public health objective. The purpose of this scoping review was to examine the factors that shape physical activity participation among people from CALD backgrounds in Australia. METHODS: This scoping review followed Arksey and O'Malley's framework. Medline, Embase and CINAHL were searched with key words relating to 'physical activity', 'CALD' and 'Australia' in July 2021 and again in February 2022 for qualitative studies published in English since 2000. Exclusion criteria were: participants < 18 years old, studies specifically focusing on populations with health issues, pregnant or postpartum states. Methodological quality of included studies was evaluated using the Critical Appraisal Skills Programme with the purpose of informing future research. Data extracted from each study were analysed thematically and results were interpreted using Acculturation theory. RESULTS: Of the 1130 studies, 17 met the inclusion criteria. Findings from each study were captured in three themes: Perceptions of physical activity; Acceptability and Appropriateness; and Access. Following migration, a decrease in physical activity, especially leisure-time activity, was reported. Common factors influencing physical activity engagement included perceptions of physical activity and wellbeing; language, financial and environmental barriers; as well as social, cultural, and religious considerations. CONCLUSION: This review identified several factors which may interact and contribute to the decline in self-reported physical activity upon migration. Findings from this review may be used to inform future health promotion initiatives targeting people from CALD backgrounds. Future research may benefit from devising a shared definition of physical activity and studying different CALD communities over time.

What are the core recommendations for gout management in first line and specialist care? Systematic review of clinical practice guidelines.

BACKGROUND: Gout is the most common inflammatory arthritis, increasing in prevalence and burden. Of the rheumatic diseases, gout is the best-understood and potentially most manageable condition. However, it frequently remains untreated or poorly managed. The purpose of this systematic review is to identify Clinical Practice Guidelines (CPG) regarding gout management, evaluate their quality, and to provide a synthesis of consistent recommendations in the high-quality CPGs. METHODS: Gout management CPGs were eligible for inclusion if they were (1) written in English and published between January 2015-February 2022; focused on adults aged ≥ 18 years of age; and met the criteria of a CPG as defined by the Institute of Medicine; and (2) were rated as high quality on the Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument. Gout CPGs were excluded if they required additional payment to access; only addressed recommendations for the system/organisation of care and did not include interventional management recommendations; and/or included other arthritic conditions. OvidSP MEDLINE, Cochrane, CINAHL, Embase and Physiotherapy Evidence Database (PEDro) and four online guideline repositories were searched. RESULTS: Six CPGs were appraised as high quality and included in the synthesis. Clinical practice guidelines consistently recommended education, commencement of non-steroidal anti-inflammatories, colchicine or corticosteroids (unless contraindicated), and assessment of cardiovascular risk factors, renal function, and co-morbid conditions for acute gout management. Consistent recommendations for chronic gout management were urate lowering therapy (ULT) and continued prophylaxis recommended based on individual patient characteristics. Clinical practice guideline recommendations were inconsistent on when to initiate ULT and length of ULT, vitamin C intake, and use of pegloticase, fenofibrate and losartan. CONCLUSION: Management of acute gout was consistent across CPGs. Management of chronic gout was mostly consistent although there were inconsistent recommendations regarding ULT and other pharmacological therapies. This synthesis provides clear guidance that can assist health professionals to provide standardised, evidence-based gout care. TRIAL REGISTRATION: The protocol for this review was registered with Open Science Framework (DOI https://doi.org/10.17605/OSF.IO/UB3Y7 ).

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.

What are the core recommendations for rheumatoid arthritis care? Systematic review of clinical practice guidelines.

Systematic r eview to evaluate the quality of the clinical practice guidelines (CPG) for rheumatoid arthritis (RA) management and to provide a synthesis of high-quality CPG recommendations, highlighting areas of consistency, and inconsistency. Electronic searches of five databases and four online guideline repositories were performed. RA management CPGs were eligible for inclusion if they were written in English and published between January 2015 and February 2022; focused on adults ≥ 18 years of age; met the criteria of a CPG as defined by the Institute of Medicine; and were rated as high quality on the Appraisal of Guidelines for Research and Evaluation II instrument. RA CPGs were excluded if they required additional payment to access; only addressed recommendations for the system/organization of care and did not include interventional management recommendations; and/or included other arthritic conditions. Of 27 CPGs identified, 13 CPGs met eligibility criteria and were included. Non-pharmacological care should include patient education, patient-centered care, shared decision-making, exercise, orthoses, and a multi-disciplinary approach to care. Pharmacological care should include conventional synthetic disease modifying anti-rheumatic drugs (DMARDs), with methotrexate as the first-line choice. If monotherapy conventional synthetic DMARDs fail to achieve a treatment target, this should be followed by combination therapy conventional synthetic DMARDs (leflunomide, sulfasalazine, hydroxychloroquine), biologic DMARDS and targeted synthetic DMARDS. Management should also include monitoring, pre-treatment investigations and vaccinations, and screening for tuberculosis and hepatitis. Surgical care should be recommended if non-surgical care fails. This synthesis offers clear guidance of evidence-based RA care to healthcare providers. TRIAL REGISTRATION: The protocol for this review was registered with Open Science Framework ( https://doi.org/10.17605/OSF.IO/UB3Y7 ).

Broken Machines or Active Bodies? Part 3. Five Recommendations to Shift the Way Clinicians Communicate With People Who Are Seeking Care for Osteoarthritis.

SYNOPSIS: In parts 1 and 2 of this series, we highlighted the dominant impairment way of talking about osteoarthritis: talking that frames osteoarthritis as a disease of cartilage worsened by physical activity that can only be "cured" by replacing the joint. An alternative understanding that counters common misconceptions about osteoarthritis, and links physical activity and healthy lifestyles to improvements in symptoms is likely a prerequisite for sustainable behavior change. It is insufficient to tell people with osteoarthritis that regular physical activity is important; people need to understand and experience how physical activity can help. Here, we offer suggestions for how clinicians can shift from focusing on what people cannot do because of osteoarthritis, toward focusing on what people can do to improve their health and maintain "active bodies." J Orthop Sports Phys Ther 2023;53(7):1-6. doi:10.2519/jospt.2023.11881.

Predicting 30-day readmission following total knee arthroplasty using machine learning and clinical expertise applied to clinical administrative and research registry data in an Australian cohort.

BACKGROUND: Thirty-day readmission is an increasingly important problem for total knee arthroplasty (TKA) patients. The aim of this study was to develop a risk prediction model using machine learning and clinical insight for 30-day readmission in primary TKA patients. METHOD: Data used to train and internally validate a multivariable predictive model were obtained from a single tertiary referral centre for TKA located in Victoria, Australia. Hospital administrative data and clinical registry data were utilised, and predictors were selected through systematic review and subsequent consultation with clinicians caring for TKA patients. Logistic regression and random forest models were compared to one another. Calibration was evaluated by visual inspection of calibration curves and calculation of the integrated calibration index (ICI). Discriminative performance was evaluated using the area under the receiver operating characteristic curve (AUC-ROC). RESULTS: The models developed in this study demonstrated adequate calibration for use in the clinical setting, despite having poor discriminative performance. The best-calibrated readmission prediction model was a logistic regression model trained on administrative data using risk factors identified from systematic review and meta-analysis, which are available at the initial consultation (ICI = 0.012, AUC-ROC = 0.589). Models developed to predict complications associated with readmission also had reasonable calibration (ICI = 0.012, AUC-ROC = 0.658). CONCLUSION: Discriminative performance of the prediction models was poor, although machine learning provided a slight improvement. The models were reasonably well calibrated, meaning they provide accurate patient-specific probabilities of these outcomes. This information can be used in shared clinical decision-making for discharge planning and post-discharge follow up.

Broken Machines or Active Bodies? Part 1. Ways of Talking About Health and Why It Matters.

SYNOPSIS: This editorial series raises awareness among clinicians about how ways of talking about orthopaedic conditions can influence what people who are seeking health care (1) think about their health and (2) what they do to manage their health. In part 1, we introduce you to ways of talking about health, using osteoarthritis as a case study. In part 2, we describe 2 contrasting ways of talking about osteoarthritis and how changing the way you share information and ideas with people seeking care may impact clinical decisions. In part 3, we offer strategies to help you shift the way you communicate with people with osteoarthritis to promote uptake of best practice recommendations and support healthy, active lifestyles. J Orthop Sports Phys Ther 2023;53(5):1-3. doi:10.2519/jospt.2023.11879.

Core Recommendations for Osteoarthritis Care: A Systematic Review of Clinical Practice Guidelines.

OBJECTIVE: To evaluate the quality of clinical practice guidelines (CPGs) for interventions in management of osteoarthritis (OA) and to provide a synthesis of high-quality CPG recommendations. METHODS: Five databases (OvidSP Medline, Cochrane, Cumulative Index to Nursing and Allied Health Literature [CINAHL], Embase, and the Physiotherapy Evidence Database [PEDro]) and 4 online guideline repositories were searched. CPGs for the management of OA were included if they were 1) written in English and published from January 2015 to February 2022, focused on adults age ≥18 years, and met the criteria of a CPG as defined by the Institute of Medicine; and 2) were rated as high quality on the Appraisal of Guidelines for Research and Evaluation II (AGREE II) instrument. CPGs for OA were excluded if they were available via institutional access only, only addressed recommendations for the system/organization of care and did not include interventional management recommendations, and/or included other arthritic conditions. RESULTS: Of 20 eligible CPGs, 11 were appraised as high quality and included in the synthesis. Of interest were the hip, knee, hand, and glenohumeral joints and/or polyarticular OA. Consistent recommendations were that care should be patient centered and include exercise, education, and weight loss (where appropriate). Nonsteroidal antiinflammatory drugs and surgical interventions were recommended for disabling OA that had not improved with nonsurgical care. Hand orthoses should be recommended for patients with hand OA. CONCLUSION: This synthesis of high-quality CPGs for OA management offers health care providers with clear, simple guidance of recommended OA care to improve patient outcomes.

Established and Novel Risk Factors for 30-Day Readmission Following Total Knee Arthroplasty: A Modified Delphi and Focus Group Study to Identify Clinically Important Predictors.

Thirty-day readmission following total knee arthroplasty (TKA) is an important outcome influencing the quality of patient care and health system efficiency. The aims of this study were (1) to ascertain the clinical importance of established risk factors for 30-day readmission risk and give clinicians the opportunity to suggest and discuss novel risk factors and (2) to evaluate consensus on the importance of these risk factors. This study was conducted in two stages: a modified Delphi survey followed by a focus group. Orthopaedic surgeons and anaesthetists involved in the care of TKA patients completed an anonymous survey to judge the clinical importance of risk factors selected from a systematic review and meta-analysis and to suggest other clinically meaningful risk factors, which were then discussed in a focus group designed using elements of nominal group technique. Eleven risk factors received a majority (≥50%) vote of high importance in the Delphi survey overall, and six risk factors received a majority vote of high importance in the focus group overall. Lack of consensus highlighted the fact that this is a highly complex problem which is challenging to predict and which depends heavily on risk factors which may be open to interpretation, difficult to capture, and dependent upon personal clinical experience, which must be tailored to the individual patient.

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.

Understanding the Impact and Tackling the Burden of Osteoarthritis for Aboriginal and Torres Strait Islander People.

OBJECTIVE: The aim of this study was to understand and describe the lived experience of Aboriginal and Torres Strait Islander people with osteoarthritis. METHODS: Qualitative study guided by cultural security, which ensures that research is conducted in a way that will not compromise the cultural values, beliefs, and expectations of Aboriginal and Torres Strait Islander people. Participants were purposively sampled through the networks of project staff. Research yarns (a cultural form of conversation used as a data gathering tool) were conducted with 25 Aboriginal and Torres Strait Islander adults with self-reported osteoarthritis in Western Australia and Victoria, Australia. Data were analyzed using a framework approach and presented through composite storytelling (hypothetical stories representing an amalgam of participants' experiences). RESULTS: Two composite stories were constructed to reflect themes relating to beliefs and knowledge, impact, coping, and health care experiences. Common beliefs held by participants were that osteoarthritis is caused by previous physically active lifestyles. Many participants feared for their future, increasing disability and needing a wheelchair. Pain associated with osteoarthritis impacted daily activities, sleep, work, family, and social life and cultural activities. Multidimensional impacts were often experienced within complex health or life circumstances and associated with increased anxiety and depression. Most participants reported negative health care experiences, characterized by poor patient-provider communication. CONCLUSION: Our findings highlight that osteoarthritis is a multidimensional issue for Aboriginal and Torres Strait Islander people that permeates all aspects of life and highlights the need for integrated, multidisciplinary care that is culturally informed and individualized to patient need.