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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 sub-scales 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 two years after surgery, but not at one 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 two 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. CONCLUSION: 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: Variations in defining poor response to total knee arthroplasty (TKA) impede comparisons of response after TKA over time and across hospitals. This study aimed to compare the prevalence, overlap, and discriminative accuracy of 15 definitions of poor response after TKA using 2 databases. METHODS: Data of patients one year after primary TKA from the Dutch Arthroplasty Register (n = 12,275) and the Osteoarthritis Initiative database (n = 204) were used to examine the prevalence, overlap (estimated by Cohen's kappa), and discriminative accuracy (sensitivity, specificity, positive predictive value, negative predictive value, and Youden index) of 15 different definitions of poor response after TKA. In the absence of a gold standard for measuring poor response to TKA, the numeric rating scale satisfaction (≤ 6 'poor responder') and the global assessment of knee impact (dichotomized: ≥ 4 'poor responder') were used as anchors for assessing discriminative accuracy for the Dutch Arthroplasty Register and Osteoarthritis Initiative dataset, respectively. These anchors were chosen based on a prior qualitative study that identified (dis)satisfaction as a central theme of poor responses to TKA by patients and knee specialists. RESULTS: The median (25th to 75th percentile) prevalence of poor responders in the examined definitions was 18.5% (14.0 to 25.5%), and the median Cohen's kappa for the overlap between pairs of definitions was 0.41 (0.32 to 0.59). Median (25th to 75th percentile) sensitivity was 0.45 (0.39 to 0.54), specificity was 0.86 (0.82 to 0.94), positive predictive value was 0.45 (0.34 to 0.62), negative predictive value was 0.89 (0.87 to 0.89), and the Youden index was 0.36 (0.20 to 0.43). CONCLUSIONS: This study found a lack of overlap between different definitions of poor response to TKA. None of the examined definitions adequately classified poor responders to TKA. In contrast, the absence of a poor response could be classified with confidence.
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BACKGROUND: Opioids are commonly used both before and after total joint arthroplasty (TJA). OBJECTIVE: The objective of this study was to estimate the long-term effects of pre- and perioperative opioid use in patients undergoing TJA. METHODS: We used linked population datasets to identify all (n =18,666) patients who had a publicly funded TJA in New Zealand between 2011 and 2013. We used propensity score matching to match individuals who used opioids either before surgery, during hospital stay, or immediately post-discharge with individuals who did not based on a comprehensive set of covariates. Regression analysis was used to estimate the effect of opioid use on health and socio-economic outcomes over 5 years. RESULTS: Opioid use in the 3 months prior to surgery was associated with significant increases in healthcare utilization and costs (number of hospitalizations 6%, days spent in hospital 14.4%, opioid scripts dispensed 181%, and total healthcare costs 11%). Also increased were the rate of receiving social benefits (2 percentage points) and the rates of opioid overdose (0.5 percentage points) and mortality (3 percentage points). Opioid use during hospital stay or post-discharge was associated with increased long-term opioid use, but there was little evidence of other adverse effects. CONCLUSIONS: Opioid use before TJA is associated with significant negative health and economic consequences and should be limited. This has implications for opioid prescribing in primary care. There is little evidence that peri- or post-operative opioid use is associated with significant long-term detriments.
Opioids are commonly used both before and after total joint replacement surgery to manage pain in patients with osteoarthritis. This study investigates the long-term consequences of opioid use around total joint replacement surgery in New Zealand during 20112013 using administrative data. We compare the outcomes of surgery patients who used opioids (treatment group) to those who did not (control group) but who had very similar pre-surgery characteristics as the treatment cohort. We find that opioid use in the months prior to surgery was associated with significant increases in healthcare utilization and costs, higher likelihood of receiving social benefits, and higher risk of opioid overdose and mortality 5 years post-surgery. Opioid use during hospital stay or post-discharge was associated with increased long-term opioid use, but there was little evidence of other adverse effects. These results highlight the importance of ongoing efforts to reduce opioid use before surgery.
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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.
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Diversidad Cultural , Ejercicio Físico , Femenino , Embarazo , Humanos , Adolescente , Lenguaje , Australia , Investigación CualitativaRESUMEN
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.
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Artroplastia de Reemplazo de Rodilla , Procedimientos Ortopédicos , Humanos , Femenino , Masculino , Anciano , Inteligencia Artificial , Toma de Decisiones Clínicas , ComunicaciónRESUMEN
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: Previous research has focused on the perioperative or short-term (<1 year) mortality rate of total knee arthroplasty (TKA), leaving the long-term (>1 year) mortality rate unresolved. In this study, we calculated the mortality rate up to 15 years after primary TKA. METHODS: Data from the New Zealand Joint Registry from April 1998 to December 2021 were analyzed. Patients aged 45 years or older who underwent TKA for osteoarthritis were included. Mortality data were linked with national records from births, deaths, and marriages. To determine the expected mortality rates in the general population, age-sex-specific life tables from statistics New Zealand were used. Mortality rate was presented as standardized mortality ratios (SMRs) - a comparison of relative mortality rate between the TKA and general populations. In total, 98,156 patients with a median follow-up of 7.25 years (range, 0.00 to 23.74) were included. RESULTS: Over the entire follow-up period, 22,938 patients (23.4%) had died. The overall SMR for the TKA cohort was 1.08 (95% confidence interval (CI): 1.06 to 1.09), suggesting that TKA patients have an 8% higher mortality rate compared to the general population. However, a reduction in short-term mortality rate was observed for TKA patients up to 5 years post TKA (SMR 5 years post TKA; 0.59 95% CI: 0.57 to 0.60]). On the contrary, a significantly increased long-term mortality rate was observed in TKA patients with greater than 11 years of follow-up, particularly in men over the age of 75 years (SMR 11 to 15 years post TKA for males ≥ 75 years; 3.13 [95% CI: 2.95 to 3.31]). CONCLUSION: The results suggest a reduction in short-term mortality rate for patients who undergo primary TKA. However, there is an increased long-term mortality rate particularly in men over the age of 75 years. Importantly, the mortality rates observed in this study cannot be causally attributed to TKA alone.
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Artroplastia de Reemplazo de Rodilla , Osteoartritis de la Rodilla , Osteoartritis , Femenino , Humanos , Masculino , Artroplastia de Reemplazo de Rodilla/métodos , Predicción , Nueva Zelanda/epidemiología , Osteoartritis/cirugía , Osteoartritis de la Rodilla/cirugía , Sistema de Registros , Persona de Mediana Edad , AncianoRESUMEN
BACKGROUND: Conflicting reports exist about the effect of offset variation on functional outcomes following total hip arthroplasty. Reproducing native hip offset is thought to optimize function by restoring biomechanics and appropriately tensioning the hip abductor muscles. The aim of this study is to assess the effect of failing to restore global hip offset in comparison to the native contralateral hip. METHODS: A retrospective analysis of a prospective patient cohort was performed on patients undergoing an elective primary total hip arthroplasty. A total of 414 patients who had a minimum of 12 months of follow-up were included. Postoperative plain radiographs were analyzed for offset and compared to the contralateral native hip. Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Veterans RAND 12 (VR-12) scores were assessed preoperatively and at 12 months postoperatively. RESULTS: Regression analyses indicated that a reduction in offset of >20 mm resulted in worse WOMAC pain (P = .005) and motion (P = .015) scores compared to those with maintained offset. WOMAC function (P = .063), global (P = .025), and VR-12 scores were not affected (physical P = .656; mental P = .815). Reduction in offset up to 20 mm and increased offset were not significantly associated with patient-reported outcome measures (P-values ranged from .102 to .995). CONCLUSION: This study demonstrated an association between reduction in offset by >20 mm and worse WOMAC pain and motion scores following total hip arthroplasty. Surgeons should avoid decreases in offset >20 mm in order to optimize functional outcomes.
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Artroplastia de Reemplazo de Cadera , Humanos , Artroplastia de Reemplazo de Cadera/métodos , Estudios Retrospectivos , Estudios Prospectivos , Resultado del Tratamiento , DolorRESUMEN
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.
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Artroplastia de Reemplazo de Rodilla , Sistemas de Apoyo a Decisiones Clínicas , Osteoartritis de la Rodilla , Humanos , Articulación de la Rodilla/cirugía , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Osteoartritis de la Rodilla/diagnóstico , Osteoartritis de la Rodilla/cirugía , Pronóstico , Estudios Prospectivos , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del TratamientoRESUMEN
PURPOSE: It is difficult to counsel patients with bilateral osteoarthritis who are unsatisfied with their first knee replacement as to whether they are likely to have a better outcome after the contralateral knee is replaced. The purpose of this study was to determine whether predictive factors can be found to prognosticate outcome of the second-side knee replacement when a patient has an unsatisfactory response to the first, with the hypothesis that predictors, such as prosthetic factors and radiographic level of osteoarthritis, may be able to predict a satisfactory response to the contralateral knee replacement. MATERIALS AND METHODS: An analysis of staged bilateral knee replacements performed at a tertiary arthroplasty centre from 2012 to 2018 was undertaken. A total of 550 knee replacements in 275 patients were included in this study. The primary variable measured was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Satisfactory response to surgery was defined as a WOMAC score improved by 17 points or more, and 56 or greater. Patients who did not achieve a satisfactory response with their first knee replacement were further analysed for predictive factors (age, sex, pre-operative score, mental score, socioeconomic status, type of prosthesis, use of navigation, patella resurfacing and radiographic osteoarthritis) of an unsatisfactory response for their contralateral knee replacement. RESULTS: Overall, 44 (16%) patients failed to achieve a satisfactory response from both their first and contralateral knee replacements. The factor most predictive of an unsatisfactory response to their first knee replacement was pre-operative mental health score. However, in patients who did not achieve a satisfactory response with their first knee replacement, radiographic osteoarthritis, as measured by the Kellgren-Lawrence (KL) score was the main predictor of satisfactory response for their contralateral knee replacement. Only patients with KL grade 4 osteoarthritis were likely to have a satisfactory response with their contralateral knee replacements (KL4 versus KL3, Odds ratio 3.57 (CI 1.26-10.03) p = 0.016*). Patients with KL grade 3 osteoarthritis were unlikely to have a satisfactory response, and in this series, no patient with KL grade 2 osteoarthritis had a satisfactory response. CONCLUSION: In a patient who has an unsatisfactory response to their first knee replacement, the best predictor of achieving a satisfactory response to his/her contralateral knee replacement is the level of radiographic osteoarthritis in that knee. LEVEL OF EVIDENCE: IV: Retrospective Cohort study.
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Artroplastia de Reemplazo de Rodilla , Osteoartritis de la Rodilla , Femenino , Humanos , Articulación de la Rodilla/diagnóstico por imagen , Articulación de la Rodilla/cirugía , Masculino , Osteoartritis de la Rodilla/diagnóstico por imagen , Osteoartritis de la Rodilla/cirugía , Rótula/cirugía , Estudios Retrospectivos , Resultado del TratamientoRESUMEN
BACKGROUND: Computer navigation techniques can potentially improve both the accuracy and precision of prosthesis implantation in total knee arthroplasty (TKA) but its impact on quality-of-life outcomes following surgery remains unestablished. METHODS: An institutional arthroplasty registry was queried to identify patients with TKA performed between January 1, 2007 and December 31, 2019. Propensity score matching based on demographical, medical, and surgical variables was used to match computer-navigated to conventionally referenced cases. The primary outcomes were Veterans RAND 12 Item Health Survey scores (VR-12 PCS and MCS), Short Form 6 Dimension utility values (SF-6D), and quality-adjusted life years (QALYs) in the first 7 years following surgery. RESULTS: A total of 629 computer-navigated TKAs were successfully matched to 1,351 conventional TKAs. The VR-12 PCS improved by a mean of 12.75 and 11.94 points in computer-navigated and conventional cases at 12-month follow-up (P = .25) and the VR-12 MCS by 6.91 and 5.93 points (P = .25), respectively. The mean VR-12 PCS improvement at 7-year follow-up (34.4% of the original matched cohort) for navigated and conventional cases was 13.00 and 12.92 points (P = .96) and for the VR-12 MCS was 4.83 and 6.30 points (P = .47), respectively. The mean improvement in the SF-6D utility score was 0.164 and 0.149 points at 12 months (P = .11) and at 7 years was 0.115 and 0.123 points (P = .69), respectively. Computer-navigated cases accumulated 0.809 QALYs in the first 7 years, compared to 0.875 QALYs in conventionally referenced cases (P = .65). There were no differences in these outcomes among a subgroup analysis of obese patients (body mass index ≥ 30 kg/m2). CONCLUSION: The use of computer navigation did not provide an incremental benefit to quality-of-life outcomes at a mean of 2.9 years following primary TKA performed for osteoarthritis when compared to conventional referencing techniques.
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Artroplastia de Reemplazo de Rodilla , Osteoartritis de la Rodilla , Cirugía Asistida por Computador , Artroplastia de Reemplazo de Rodilla/efectos adversos , Computadores , Humanos , Osteoartritis de la Rodilla/etiología , Osteoartritis de la Rodilla/cirugía , Puntaje de Propensión , Calidad de Vida , Cirugía Asistida por Computador/métodos , 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
OBJECTIVE: To explore the ways in which people talk about knee osteoarthritis and how this may influence engagement in physical activity and activity-based interventions as recommended by clinical practice guidelines. DESIGN: A qualitative synthesis using discourse analysis methods. METHODS: Systematic review methods were used to identify qualitative studies exploring the perceptions of people with knee osteoarthritis, their carers, and/or clinicians. Methodological quality was evaluated through the use of the Critical Appraisal Skills Programme. Raw quotes extracted from each study were analyzed with inductive discourse analysis. RESULTS: A search of five electronic databases from inception until August 2019 yielded 778 articles. Sixty-two articles from 56 studies were included, reporting data (1,673 direct quotes) from people with knee osteoarthritis, carers, and clinicians in 16 countries. Two overarching discourses were identified-impairment and participation. The overarching impairment discourse prevailed in all participant groups and study settings. In this discourse, knee osteoarthritis was likened to a machine that inevitably wore down over time and required a doctor to repair. The overarching participatory discourse almost always coexisted alongside an impairment discourse. According to this discourse, a "busy body" was perceived as "healthy," and people could remain active despite knee osteoarthritis. CONCLUSION: The prevailing impairment discourse may potentially discourage people from using knees that have passed their "use-by date" and increase reliance on doctors to repair joint damage. Consistent with recommendations in clinical practice guidelines, a participatory discourse may provide an alternative way of communicating that may encourage people with knee osteoarthritis to continue to engage in physical activity by focusing on what they can do, rather than what they cannot do.
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Osteoartritis de la Cadera , Osteoartritis de la Rodilla , Ejercicio Físico , Humanos , Investigación CualitativaRESUMEN
BACKGROUND: The use of general practice electronic health records (EHRs) for research purposes is in its infancy in Australia. Given these data were collected for clinical purposes, questions remain around data quality and whether these data are suitable for use in prediction model development. In this study we assess the quality of data recorded in 201,462 patient EHRs from 483 Australian general practices to determine its usefulness in the development of a clinical prediction model for total knee replacement (TKR) surgery in patients with osteoarthritis (OA). METHODS: Variables to be used in model development were assessed for completeness and plausibility. Accuracy for the outcome and competing risk were assessed through record level linkage with two gold standard national registries, Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) and National Death Index (NDI). The validity of the EHR data was tested using participant characteristics from the 2014-15 Australian National Health Survey (NHS). RESULTS: There were substantial missing data for body mass index and weight gain between early adulthood and middle age. TKR and death were recorded with good accuracy, however, year of TKR, year of death and side of TKR were poorly recorded. Patient characteristics recorded in the EHR were comparable to participant characteristics from the NHS, except for OA medication and metastatic solid tumour. CONCLUSIONS: In this study, data relating to the outcome, competing risk and two predictors were unfit for prediction model development. This study highlights the need for more accurate and complete recording of patient data within EHRs if these data are to be used to develop clinical prediction models. Data linkage with other gold standard data sets/registries may in the meantime help overcome some of the current data quality challenges in general practice EHRs when developing prediction models.
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Exactitud de los Datos , Registros Electrónicos de Salud , Adulto , Australia , Medicina Familiar y Comunitaria , Humanos , Persona de Mediana Edad , Modelos Estadísticos , PronósticoRESUMEN
BACKGROUND: In deciding pharmacotherapy treatment, doctors have to balance the risks and benefits of treatment, and their preferences may not always align with patient preferences. AIM: A pilot study to explore decision-making regarding treatment with antipsychotic medications among doctors and patients. METHODS: A discrete choice experiment (DCE), comprised of systematically structured choice tasks, in which doctors and patients were asked to trade off between attributes of antipsychotic medications, each described in terms of mode of administration, effectiveness (on positive and negative symptoms) and side effect profiles. Participants also ranked different factors that they consider important when choosing an antipsychotic medication. RESULTS: 52 doctors and 49 patients completed the survey. Doctors accepted a higher risk of side effects than patients if it achieved better efficacy. Patients perceived long-acting injectables (LAIs) to be easier than taking tablets every day. Issues of embarrassment, pain and fear of needles were not rated as highly by patients, as anticipated by doctors. CONCLUSIONS: Doctors and patients demonstrated differences in decision-making about treatment with antipsychotic medications. Addressing these issues could facilitate shared decision-making, with the goal of improving patient adherence to antipsychotic medications, and thereby improve patient outcomes.
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Antipsicóticos , Médicos , Antipsicóticos/efectos adversos , Humanos , Prioridad del Paciente , Proyectos Piloto , Encuestas y CuestionariosRESUMEN
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
PURPOSE: As patient-reported outcome measures (PROMs) are increasingly integrated into clinical practice, there is a need to translate collected data into valuable information to guide and improve the quality and value of patient care. The purpose of this study was to investigate health-related quality-of-life (QoL) trajectories in the 5 years following total knee replacement (TKR) and the patient characteristics associated with these trajectories. The feasibility of translating QoL trajectories into valuable information for guiding patient-centered care was also explored. METHODS: Data on patients who underwent TKR between 2006 and 2011 from a single-institution registry were extracted including patient-reported QoL (captured using the Short Form Survey (SF-12) instrument) up to 5 years post-surgery. QoL trajectories were modelled using latent class growth analysis. Quality-adjusted life-years (QALYs) were calculated to illustrate longer term health benefit. Multinomial logistic regression analyses were performed to examine the association between trajectory groups and baseline patient characteristics. RESULTS: After exclusions, 1553 patients out of 1892 were included in the analysis. Six unique QoL trajectories were identified; with differing levels at baseline and improvement patterns post-surgery. Only 18.4% of patients were identified to be in the most positive QoL trajectory (low baseline, large sustainable improvement after surgery) associated with the greatest gain in QALY. These patients were likely to be younger, have no co-morbidities and report greater pain at pre-surgery than most in other QoL trajectories. CONCLUSIONS: Our findings demonstrate the importance of underlying heterogeneity in QoL trajectories, resulting in variable QALY gains. There is scope in translating routinely collected PROMs to improve shared decision-making allowing for more patient engagement. However, further research is required to identify suitable approaches of its implementation into practice to guide clinical care and maximize patient outcomes.
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Artroplastia de Reemplazo de Rodilla/psicología , Artroplastia de Reemplazo de Rodilla/rehabilitación , Medición de Resultados Informados por el Paciente , Atención Dirigida al Paciente/métodos , Calidad de Vida/psicología , Anciano , Comorbilidad , Femenino , Estado de Salud , Humanos , Masculino , Dolor , Años de Vida Ajustados por Calidad de Vida , Sistema de Registros , Encuestas y CuestionariosRESUMEN
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.
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Artroplastia de Reemplazo de Rodilla , Osteoartritis de la Rodilla/cirugía , Satisfacción del Paciente , Calidad de Vida , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Investigación Cualitativa , Sistema de Registros , Encuestas y CuestionariosRESUMEN
BACKGROUND: Although education, exercise, and weight loss are recommended for management of knee osteoarthritis, the additional benefits of incorporating weight loss strategies into exercise interventions have not been well investigated. The aim of this study is to compare, in a private health insurance setting, the clinical- and cost-effectiveness of a remotely-delivered, evidence- and theory-informed, behaviour change intervention targeting exercise and self-management (Exercise intervention), with the same intervention plus active weight management (Exercise plus weight management intervention), and with an information-only control group for people with knee osteoarthritis who are overweight or obese. METHODS: Three-arm, pragmatic parallel-design randomised controlled trial involving 415 people aged ≥45 and ≤ 80 years, with body mass index ≥28 kg/m2 and < 41 kg/m2 and painful knee osteoarthritis. Recruitment is Australia-wide amongst Medibank private health insurance members. All three groups receive access to a bespoke website containing information about osteoarthritis and self-management. Participants in the Exercise group also receive six consultations with a physiotherapist via videoconferencing over 6 months, including prescription of a strengthening exercise and physical activity program, advice about management, and additional educational resources. The Exercise plus weight management group receive six consultations with a dietitian via videoconferencing over 6 months, which include a very low calorie ketogenic diet with meal replacements and resources to support behaviour change, in addition to the interventions of the Exercise group. Outcomes are measured at baseline, 6 and 12 months. Primary outcomes are self-reported knee pain and physical function at 6 months. Secondary outcomes include weight, physical activity levels, quality of life, global rating of change, satisfaction with care, knee surgery and/or appointments with an orthopaedic surgeon, and willingness to undergo surgery. Additional measures include adherence, adverse events, self-efficacy, and perceived usefulness of intervention components. Cost-effectiveness of each intervention will also be assessed. DISCUSSION: This pragmatic study will determine whether a scalable remotely-delivered service combining weight management with exercise is more effective than a service with exercise alone, and with both compared to an information-only control group. Findings will inform development and implementation of future remotely-delivered services for people with knee osteoarthritis. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12618000930280 (01/06/2018).