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BACKGROUND: Depression is associated with inferior outcomes following hip or knee arthroplasty, though it remains unclear if this relationship is modifiable. This study examined the association between pharmacologic treatment of depression and patient-reported outcomes. METHODS: This retrospective cohort study of 1,651 total hip arthroplasty (THA) and 1,792 total knee arthroplasty (TKA) procedures between October 2012 and June 2019 used institutional registry data linked to nationwide pharmaceutical claims. The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) global score, with pain and function subscales assessed as secondary outcomes. The TKA and THA patients were analyzed separately via mixed-effect linear regression to compare patients who had depression treated with antidepressants (TKA, n = 210; THA, n = 150) to those who had untreated depression (TKA, n = 43; THA; n = 50), and those who did not have depression (TKA, n = 1,539; THA, n = 1,451). RESULTS: Among patients who had depression, not receiving preoperative antidepressant therapy was associated with smaller improvements in WOMAC global scores (TKA, adjusted mean difference [MD]: -13.1 points, 95% CI [confidence interval]: -21.4 to -4.8; THA, MD: -8.5 points, 95% CI: -15.7 to -1.2) at 2 years after surgery, but not at 1 year (TKA, MD: -5.4 points, 95% CI: -12.9 to 2.1; THA, MD: -6.3 points, 95% CI: -12.9 to 0.3). Those who did not have depression had similar improvements in WOMAC global scores to those who had treated depression at both one (TKA, MD: 0.8 points, 95% CI: -2.7 to 4.4; THA, MD: 1.8 points, 95% CI: -1.8 to 5.4) and 2 years (TKA, MD: -1.1 points, 95% CI: -4.9 to 2.7; THA, MD: -1.6 points, 95% CI: -5.6 to 2.3). The findings were consistent with secondary outcomes. CONCLUSIONS: Among patients who have depression, antidepressant therapy before TKA or THA is associated with improved outcomes. Additional studies are needed to establish the impact of interventions to address untreated depression before surgery.
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BACKGROUND: Patient-reported outcome measure (PROM) questionnaires in national arthroplasty registries often have low response rates leading to questions about data reliability. In Australia, the SMART (St. Vincent's Melbourne Arthroplasty Outcomes) registry captures all elective total hip (THA) and total knee (TKA) arthroplasty patients with an approximate 98% response rate for preoperative and 12-month PROM scores. This high response rate is due to dedicated registry staff following up patients who do not initially respond (subsequent responders). This study compared initial responders to subsequent responders to find differences in 12-month PROM outcomes for THA and TKA. METHODS: All elective THA and TKA patients for osteoarthritis from 2012 to 2021 captured by the SMART registry were included. In total, 1,333 THA and 1,340 TKA patients were included. The PROM scores were assessed using the Veterans-RAND 12 (VR12) and Western Ontario and McMasters Universities Arthritis Index (WOMAC) questionnaires. The primary outcome was differences in mean 12-month PROM scores between initial and subsequent responders. RESULTS: Baseline characteristics and PROM scores were similar between initial and subsequent responders. However, 12-month PROM scores varied significantly. The adjusted mean difference showed that for the WOMAC pain score, subsequent responders scored 3.4 points higher in the THA cohort and 7.4 points higher in the TKA cohort compared to initial responders. Significant differences were also found in other WOMAC and VR12 scores for both THA and TKA cohorts at the 12-month timepoint. CONCLUSION: This study found that significant differences in PROM outcomes postsurgery occurred in THA and TKA patients based on response to PROM questionnaires, suggesting that loss to follow-up in PROM outcomes should not be treated as missing completely at random (MCAR).
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Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Humanos , Reproducibilidad de los Resultados , Australia/epidemiología , Encuestas y Cuestionarios , Sistema de Registros , Resultado del TratamientoRESUMEN
BACKGROUND: This study aimed to evaluate the month-to-month prevalence of antibiotic dispensation in the 12 months before and after total knee arthroplasty (TKA) and total hip arthroplasty (THA) and to identify factors associated with antibiotic dispensation in the month immediately following the surgical procedure. METHODS: In total, 4,115 THAs and TKAs performed between April 2013 and June 2019 from a state-wide arthroplasty referral center were analyzed. A cross-sectional study used data from an institutional arthroplasty registry, which was linked probabilistically to administrative dispensing data from the Australian Pharmaceutical Benefits Scheme. Multivariable logistic regression was carried out to identify patient and surgical risk factors for oral antibiotic dispensation. RESULTS: Oral antibiotics were dispensed in 18.3% of patients following primary TKA and 12.0% of patients following THA in the 30 days following discharge. During the year after discharge, 66.7% of TKA patients and 58.2% of THA patients were dispensed an antibiotic at some point. Patients with poor preoperative health status were more likely to have antibiotics dispensed in the month following THA or TKA. Older age, undergoing TKA rather than THA, obesity, inflammatory arthritis, and experiencing an in-hospital wound-related or other infectious complications were associated with increased antibiotic dispensation in the 30 days following discharge. CONCLUSION: A high rate of antibiotic dispensation in the 30 days following THA and TKA has been observed. Although resource constraints may limit routine wound review for all patients by a surgeon, a select cohort may benefit from timely specialist review postoperatively. Several risk factors identified in this study may aid in identifying appropriate candidates for such changes to follow-up care.
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Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Antibacterianos/uso terapéutico , Artroplastia de Reemplazo de Cadera/efectos adversos , Artroplastia de Reemplazo de Rodilla/efectos adversos , Australia/epidemiología , Estudios Transversales , Humanos , Pacientes Ambulatorios , Complicaciones Posoperatorias/etiología , Factores de RiesgoRESUMEN
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).
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Ensayos Clínicos Controlados como Asunto/métodos , Placebos , Procedimientos Quirúrgicos Operativos , HumanosRESUMEN
PURPOSE OF REVIEW: We provide an overview of recent research into the relationship between preoperative opioid use and total joint replacement outcomes. RECENT FINDINGS: Recent findings indicate that total joint replacement patients with a history of preoperative opioid use experience higher rates of infection, revision, short-term complications, and prolonged postoperative opioid use, along with fewer improvements in pain and function following surgery. These risks are particularly pronounced among chronic opioid users. While the baseline risk profiles of these patients may contribute to higher rates of adverse outcomes, it is also plausible that certain outcomes are directly impacted by opioid use through mechanisms such as opioid-induced hyperalgesia and immunosuppression. There is little available data on the efficacy of interventions that aim to mitigate these risks. Well-designed clinical trials are needed to evaluate the efficacy of targeted perioperative interventions that aim to improve outcomes for this high-risk surgical population. Where such trials are not feasible, additional high-quality observational studies are necessary to further our understanding of the mechanisms underlying the relationships between opioid use and specific adverse outcomes.
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Analgésicos Opioides/administración & dosificación , Analgésicos Opioides/efectos adversos , Artroplastia de Reemplazo/efectos adversos , Artropatías/cirugía , Trastornos Relacionados con Opioides/complicaciones , Humanos , Artropatías/complicaciones , Trastornos Relacionados con Opioides/epidemiología , Atención Perioperativa , Pautas de la Práctica en Medicina/estadística & datos numéricos , Periodo Preoperatorio , Factores de Riesgo , Estados Unidos/epidemiologíaRESUMEN
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.
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Presupuestos , Modelos Económicos , Humanos , Análisis Costo-BeneficioRESUMEN
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.
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Investigadores , Humanos , Estudios Transversales , Ensayos Clínicos Controlados Aleatorios como Asunto , Sujetos de InvestigaciónRESUMEN
BACKGROUND: The influence of sex on the failure of débridement antibiotics and implant retention (DAIR) for treating prosthetic joint infection (PJI) is important for decision-making, patient counseling, and equitable health care. However, very few studies in the orthopaedic literature conduct sex-specific analyses. AIM: The primary aim was to determine whether sex influences treatment success after DAIR. METHODS: A systematic review and individual patient data (IPD) meta-analysis was conducted. MEDLINE (Ovid), EMBASE (Ovid), Web of Science, and Google Scholar were searched, and IPD was requested via e-mail. Patients who underwent DAIR after developing PJI within 12 months of a primary total hip or knee arthroplasty were included in the analysis. Treatment failure was defined by the Delphi International Consensus criteria. Adjusted odds ratios for treatment failure were calculated using a mixed-effects logistic regression. RESULTS: The study collected and analyzed IPD of 1,116 patients from 21 cohorts. The odds of treatment failure were 29% lower in women (odds ratio, 0.71; 95% CI 0.54 to 0.017; P = 0.017), after adjusting for duration of symptoms >7 days and Staphylococcus aureus infection (methicillin-susceptible Staphylococcus aureus or any infection with S aureus). None of the 64 studies included in the systematic review conducted a sex-specific analysis. CONCLUSION: For patients who developed a PJI within 1 year postsurgery, females have lower odds of DAIR failure than males. Other factors also have varying effects on outcome for men and women. It is essential to implement sex-specific analysis in orthopaedic research.
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Antibacterianos , Infecciones Relacionadas con Prótesis , Masculino , Humanos , Femenino , Antibacterianos/uso terapéutico , Desbridamiento , Estudios Retrospectivos , Infecciones Relacionadas con Prótesis/tratamiento farmacológico , Resultado del Tratamiento , Staphylococcus aureusRESUMEN
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.
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Total joint arthroplasty (TJA) is an effective treatment for end-stage osteoarthritis, which aims to alleviate pain and improve function and mobility. Despite the remarkable success of TJA, complications can arise, leading to unplanned hospital readmission, implant failure, morbidity and mortality. Recently, there has been a growing interest in analysing sex-based differences in diseases and response to medical interventions. This review summaries evidence pertaining to the widening gap between men and women regarding the utilization and outcome of TJA surgery. Interactions between sex and patient-reported outcome, implant failure and medical complication are complex and often demonstrate conflicting results. Significantly, there is a global consensus that men are at a higher risk of developing prosthetic joint infection following joint arthroplasty. Guided by the literature, there is a clear need for standardized methods of collecting, analysing and reporting sex-specific data to improve outcomes for both men and women who undergo TJA.
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Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Osteoartritis , Artroplastia de Reemplazo de Cadera/efectos adversos , Artroplastia de Reemplazo de Rodilla/efectos adversos , Femenino , Humanos , Masculino , Readmisión del Paciente , Resultado del TratamientoRESUMEN
BACKGROUND: The number of total joint arthroplasties (TJAs) being performed is increasing worldwide. To match this increasing demand, there has been focus on hastening patients' recovery of function. This effort has culminated in the formulation of enhanced recovery after surgery (ERAS) strategies. However, with evolving ERAS programs and new recommendations, a review of current evidence is required to provide clinicians with up-to-date information about its effect on outcomes for TJA. OBJECTIVE: The objective of this study is to assess the utility of ERAS programs on patient, health service, and economic outcomes for primary, elective total hip arthroplasty (THA) and total knee arthroplasty (TKA). METHODS: A systematic search will be conducted in Medline (Ovid), EMCARE (Ovid), EMBASE (Ovid), Web of Science, CINAHL, National Health Service Economic Evaluations Database, and the Cochrane Library. Analytical, observational, and experimental designs will be included in this systematic review. Only studies including patients undergoing primary TKA and THA comparing ERAS programs with conventional surgery and postoperative care will be included. Data related to patient outcomes, health service outcomes, safety, and economic evaluation will be extracted. RESULTS: The search terms and primary database searches have been finalized. Findings will be reported in narrative and tabular form. Where appropriate, random effects meta-analyses will be conducted for each outcome, and heterogeneity quantified with Cochran Q test and I2 statistic. Measures of effect or mean differences will be reported with 95% confidence intervals. The results of this systematic review will be disseminated in a peer-reviewed journal. CONCLUSIONS: This protocol will guide a systematic review assessing outcomes associated with ERAS surgery in primary THA and TKA. TRIAL REGISTRATION: Open Science Framework osf.io/y4bhs; https://osf.io/y4bhs. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/25581.
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PURPOSE: The St Vincent's Melbourne Arthroplasty Outcomes (SMART) Registry is an institutional clinical registry housed at a tertiary referral hospital in Australia. The SMART Registry is a pragmatic prospective database, which was established to capture a broad range of longitudinal clinical and patient-reported outcome data to facilitate collaborative research that will improve policy and practice relevant to arthroplasty surgery for people with advanced arthritis of the hip or knee. The purpose of this cohort profile paper is to describe the rationale for the SMART Registry's creation, its methods, baseline data and future plans for the Registry. A full compilation of the data is provided as a reference point for future collaborators. PARTICIPANTS: The SMART Registry cohort comprises over 13 000 consecutive arthroplasty procedures in more than 10 000 patients who underwent their procedure at St Vincent's Hospital Melbourne, since January 1998. Participant recruitment, data collection and follow-up is ongoing and currently includes up to 20 years follow-up data. FINDINGS TO DATE: SMART Registry data are used for clinical audit and feedback, as well as for a broad range of research including epidemiological studies, predictive statistical modelling and health economic evaluations. At the time of writing, there were 46 publications from SMART Registry data, with contributions from more than 67 coauthors. FUTURE PLANS: With the recent linking of the SMART Registry with Medicare Benefits Schedule and Pharmaceutical Benefits Scheme data through the Australian Institute of Health and Welfare, research into prescribing patterns and health system utilisation is currently underway. The SMART Registry is also being updated with the Clavien-Dindo classification of surgical complications.
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Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Anciano , Australia , Humanos , Programas Nacionales de Salud , Sistema de RegistrosRESUMEN
Objective The aim of this study was to identify the challenges anticipated by clinical staff in two Melbourne health services in relation to the legalisation of voluntary assisted dying in Victoria, Australia. Methods A qualitative approach was used to investigate perceived challenges for clinicians. Data were collected after the law had passed but before the start date for voluntary assisted dying in Victoria. This work is part of a larger mixed-methods anonymous online survey about Victorian clinicians' views on voluntary assisted dying. Five open-ended questions were included in order to gather text data from a large number of clinicians in diverse roles. Participants included medical, nursing and allied health staff from two services, one a metropolitan tertiary referral health service (Service 1) and the other a major metropolitan health service (Service 2). The data were analysed thematically using qualitative description. Results In all, 1086 staff provided responses to one or more qualitative questions: 774 from Service 1 and 312 from Service 2. Clinicians anticipated a range of challenges, which included burdens for staff, such as emotional toll, workload and increased conflict with colleagues, patients and families. Challenges regarding organisational culture, the logistics of delivering voluntary assisted dying under the specific Victorian law and how voluntary assisted dying would fit within the hospital's overall work were also raised. Conclusions The legalisation of voluntary assisted dying is anticipated to create a range of challenges for all types of clinicians in the hospital setting. Clinicians identified challenges both at the individual and system levels. What is known about the topic? Voluntary assisted dying became legal in Victoria on 19 June 2019 under the Voluntary Assisted Dying Act 2017. However there has been little Victorian data to inform implementation. What does this paper add? Victorian hospital clinicians anticipate challenges at the individual and system levels, and across all clinical disciplines. These challenges include increased conflict, emotional burden and workload. Clinicians report concerns about organisational culture, the logistics of delivering voluntary assisted dying under the specific Victorian law and effects on hospitals' overall work. What are the implications for practitioners? Careful attention to the breadth of staff affected, alongside appropriate resourcing, will be needed to support clinicians in the context of this legislative change.
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Actitud del Personal de Salud , Personal de Salud/psicología , Suicidio Asistido/psicología , Humanos , Cultura Organizacional , Suicidio Asistido/legislación & jurisprudencia , Encuestas y Cuestionarios , VictoriaRESUMEN
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: BackgroundThe 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.MethodsThe 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.DiscussionInvolving 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.
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INTRODUCTION: Mounting evidence now indicates that preoperative opioid use is associated with an array of complications following total joint replacement (TJR). However, evidence of these risks remains fragmented. A comprehensive and well-integrated understanding of this body of evidence is necessary to appropriately inform treatment decisions, the allocation of limited healthcare resources, and the direction of future clinical research. The proposed systematic review and meta-analysis aims to identify and synthesise the available evidence of an association between opioid use prior to TJR and postoperative complications, categorised by complication type. METHODS AND ANALYSIS: We will search MEDLINE, EMBASE, CINAHL, PsycINFO, and Web of Science from inception to April 2020. Observational and experimental studies that compare preoperative opioid users who have undergone elective TJR to opioid naïve TJR patients will be included. The primary outcomes will be postoperative complications, which will be categorised as either mortality, morbidity, or joint-related complications. The secondary outcomes will be persistent postoperative opioid use, readmission, and length of stay. Individual study quality will be assessed using the relevant NIH-NHLBI study quality assessment tools. Findings will be reported in narrative and tabular form, and, where possible, odds ratios (dichotomous outcomes) or standardised mean differences (continuous outcomes) will be reported with 95% confidence intervals. Where appropriate, random effect meta-analyses will be conducted for each outcome, and heterogeneity will be quantified using the I2 statistic and Cochran's Q test. This study will be reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Meta-analyses Of Observational Studies in Epidemiology (MOOSE) guidelines. ETHICS AND DISSEMINATION: Ethics approval will not be required as no primary or private data are being collected. Findings will be disseminated through peer-reviewed publication and presentation at academic conferences. PROSPERO REGISTRATION NUMBER: CRD42020153047.
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Analgésicos Opioides/uso terapéutico , Artroplastia de Reemplazo , Dolor Postoperatorio/prevención & control , Analgésicos Opioides/efectos adversos , Humanos , Metaanálisis como Asunto , Complicaciones Posoperatorias/inducido químicamente , Cuidados Preoperatorios , Proyectos de Investigación , Revisiones Sistemáticas como AsuntoRESUMEN
Over the past two decades, there has been a sharp rise in the use of prescription opioids. In several countries, most notably the United States, opioid-related harm has been deemed a public health crisis. As surgeons are among the most prolific prescribers of opioids, growing attention is now being paid to the role that opioids play in surgical care. While opioids may sometimes be necessary to provide patients with adequate relief from acute pain after major surgery, the impact of opioids on the quality and safety of surgical care calls for greater scrutiny. This narrative review summarizes the available evidence on rates of persistent postsurgical opioid use and highlights the need to target known risk factors for persistent postoperative use before patients present for surgery. We draw attention to the mounting evidence that preoperative opioid exposure places patients at risk of persistent postoperative use, while also contributing to an increased risk of several other adverse clinical outcomes. By discussing the prevalence of excess opioid prescribing following surgery and highlighting significant variations in prescribing practices between countries, we note that there is a pressing need to optimize postoperative prescribing practices. Guided by the available evidence, we call for specific actions to be taken to address important research gaps and alleviate the harms associated with opioid use among surgical patients.