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OBJECTIVES: The minimal important change (MIC) reflects what patients, on average, consider the smallest improvement in a score that is important to them. MIC thresholds may vary across patient populations, interventions used, posttreatment time points and derivation methods. We determine and compare MIC thresholds for the Oxford Knee Score and Oxford Hip Score (OKS/OHS) at 3 months postoperatively to 12- and 24-month thresholds in patients undergoing knee or hip arthroplasty. STUDY DESIGN AND SETTING: This cohort study used data from patients undergoing total knee arthroplasty (TKA), unicompartmental knee arthroplasty (UKA), or total hip arthroplasty (THA) at a public hospital between February 2016 and February 2023. At 3, 12, and 24 months postoperatively, patients responded to the OKS/OHS and a 7-point anchor question determining experienced changes in knee or hip pain and functional limitations. We used the adjusted predictive modeling method that accounts for the proportion improved and the reliability of the anchor question to determine MIC thresholds and their mean differences between time points. RESULTS: Complete data were obtained from 695/957 (73%), 1179/1703 (69%), and 1080/1607 (67%) patients undergoing TKA, 474/610 (78%), 438/603 (73%), and 355/507 (70%) patients undergoing UKA, and 965/1315 (73%), 978/1409 (69%), and 1059/1536 (69%) patients undergoing THA at 3, 12, and 24 months, respectively. The median age ranged from 68 to 70 years and 55% to 60% were females. The proportions improved ranged between 83% and 95%. The OKS/OHS MIC thresholds were 0.1, 4.2, and 5.1 for TKA, 1.8, 5.6, and 3.4 for UKA, and 1.3, 6.1, and 6.0 for THA at 3, 12, and 24 months postoperatively, respectively. The reliability ranged between 0.64 and 0.82, and the MIC values increased between three and 12 months but not between 12 and 24 months. CONCLUSION: Any absence of deterioration in pain and function is considered important at 3 months after knee or hip arthroplasty. Increasing thresholds over time suggest patients raise their standards for what constitutes a minimal important improvement over the first postoperative year. Besides improving our understanding of patients' views on postoperative outcomes, these clinical thresholds may aid in interpreting registry-based treatment outcome evaluations.
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Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Humanos , Femenino , Masculino , Anciano , Persona de Mediana Edad , Estudios de Cohortes , Diferencia Mínima Clínicamente Importante , Reproducibilidad de los Resultados , Resultado del Tratamiento , Factores de TiempoRESUMEN
BACKGROUND: Patient-reported outcome measures such as the Oxford Hip Score (OHS) can capture patient-centered perspectives on outcomes after total hip arthroplasty (THA). The OHS assesses hip pain and functional limitations, but defining interpretation threshold values for the OHS is warranted so that numerical OHS values can be translated into whether patients have experienced clinically meaningful changes. Therefore, we determined the minimal important change (MIC), patient acceptable symptom state (PASS), and treatment failure (TF) threshold values for the OHS at 12 and 24-month follow-up in patients undergoing THA. METHODS: This cohort study used data from patients undergoing THA at 1 public hospital between July 2016 and April 2021. At 12 and 24 months postoperatively, patients provided responses for the OHS and for 3 anchor questions about whether they had experienced changes in hip pain and function, whether they considered their symptom state to be satisfactory, and if it was not satisfactory, whether they considered the treatment to have failed. The anchor-based adjusted predictive modeling method was used to determine interpretation threshold values. Baseline dependency was evaluated using a new item-split method. Nonparametric bootstrapping was used to determine 95% confidence intervals (CIs). RESULTS: Complete data were obtained for 706 (69%) of 1,027 and 728 (66%) of 1,101 patients at 12 and 24 months postoperatively, respectively. These patients had a median age of 70 years, and 55% to 56% were female. Adjusted OHS MIC values were 6.3 (CI, 4.6 to 8.1) and 5.2 (CI, 3.6 to 6.7), adjusted OHS PASS values were 30.6 (CI, 29.0 to 32.2) and 30.5 (CI, 29.3 to 31.8), and adjusted OHS TF values were 25.5 (CI, 22.9 to 27.7) and 27.0 (CI, 25.2 to 28.8) at 12 and 24 months postoperatively, respectively. MIC values were 5.4 (CI, 2.1 to 9.1) and 5.0 (CI, 1.9 to 8.7) higher at 12 and 24 months, respectively, in patients with a more severe preoperative state. CONCLUSIONS: The established interpretation threshold values advance the interpretation and clinical use of the OHS, and may prove especially beneficial for registry-based evaluations of treatment quality. LEVEL OF EVIDENCE: Prognostic Level IV . See Instructions for Authors for a complete description of levels of evidence.
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Artroplastia de Reemplazo de Cadera , Humanos , Femenino , Anciano , Masculino , Estudios de Cohortes , Encuestas y Cuestionarios , Medición de Resultados Informados por el Paciente , Dolor , Resultado del TratamientoRESUMEN
BACKGROUND: To investigate the effect of in-person delivered behavioural interventions in people with multimorbidity and which behaviour change techniques (BCTs), targeting lifestyle behaviours, are associated with better outcomes. METHODS: Systematic review of randomised controlled trials. We searched MEDLINE, EMBASE, CENTRAL, and CINAHL and screened reference list of reviews including people with multimorbidity, registries, and citation tracking of included studies. Meta-analyses using random-effects model to assess the effect of behavioural interventions and meta-regression analyses and effectiveness ratios to investigate the impact of mediators on effect estimates. Cochrane 'Risk of Bias Tool' 2.0 and the GRADE assessment to evaluate the overall quality of evidence. RESULTS: Fourteen studies involving 1,378 people. Behavioural interventions had little to no effect on physical activity (standardised mean difference 0.38, 95% CI -0.12-0.87) and the effect on weight loss was uncertain (BMI mean difference -0.17, 95% CI -1.1-0.83) at the end-treatment follow-up. Small improvements were seen in health-related quality of life (SMD 0.29, 95% CI 0.17-0.42) and physical function (SMD 0.42, 95% CI 0.12-0.73), and moderate improvements were seen for depression symptoms (SMD -0.70, 95% CI -0.97-0.42). Studies using the BCTs 'action planning' and 'social support (practical)' reported greater physical activity and weight loss. CONCLUSIONS: Behavioural interventions targeting lifestyle behaviours may improve health-related quality of life and physical function, and reduce depression, whereas little to no effect was achieved on physical activity and weight loss in people with multimorbidity. However, the evidence for physical activity and weight loss were of low quality and the end-treatment benefits diminished over time.
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Multimorbilidad , Calidad de Vida , Humanos , Estilo de Vida , Terapia Conductista , Ejercicio FísicoRESUMEN
BACKGROUND AND PURPOSE: Developing meaningful thresholds for the Oxford Knee Score (OKS) advances its clinical use. We determined the minimal important change (MIC), patient acceptable symptom state (PASS), and treatment failure (TF) values as meaningful thresholds for the OKS at 3-, 12-, and 24-month follow-up in patients undergoing unicompartmental knee arthroplasty (UKA). PATIENTS AND METHODS: This is a cohort study with data from patients undergoing UKA collected at a hospital in Denmark between February 2016 and September 2021. The OKS was completed preoperatively and at 3, 12, and 24 months postoperatively. Interpretation threshold values were calculated with the anchor-based adjusted predictive modeling method. Non-parametric bootstrapping was used to derive 95% confidence intervals (CI). RESULTS: Complete 3-, 12-, and 24-month postoperative data was obtained for 331 of 423 (78%), 340 of 479 (71%), and 235 of 338 (70%) patients, median age of 68-69 years (58-59% females). Adjusted OKS MIC values were 4.7 (CI 3.3-6.0), 7.1 (CI 5.2-8.6), and 5.4 (CI 3.4- 7.3), adjusted OKS PASS values were 28.9 (CI 27.6-30.3), 32.7 (CI 31.5-33.9), and 31.3 (CI 29.1-33.3), and adjusted OKS TF values were 24.4 (CI 20.7-27.4), 29.3 (CI 27.3-31.1), and 28.5 (CI 26.0-30.5) at 3, 12, and 24 months postoperatively, respectively. All values statistically significantly increased from 3 to 12 months but not from 12 to 24 months. INTERPRETATION: The UKA-specific measurement properties and clinical thresholds for the OKS can improve the interpretation of UKA outcome and assist quality assessment in institutional and national registries.
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Artroplastia de Reemplazo de Rodilla , Osteoartritis de la Rodilla , Anciano , Artroplastia de Reemplazo de Rodilla/métodos , Estudios de Cohortes , Femenino , Humanos , Masculino , Osteoartritis de la Rodilla/cirugía , Periodo Posoperatorio , Sistema de RegistrosRESUMEN
INTRODUCTION: The coronavirus outbreak causes postponement of elective surgery. We evaluated how pain, function and general health were impacted by postponing elective knee and hip arthroplasty in patients with knee and hip osteoarthritis with no known surgery rescheduling date due to the coronavirus outbreak. METHODS: This study included 194 patients from a Danish public hospital with postponed elective primary knee or hip arthroplasty due to the lockdown. Patients responded to questionnaires when their surgery was cancelled and before surgery. Changes in pain and function were evaluated with the Oxford Knee and Hip Scores (OKS, OHS) and their general health with the EuroQol 5-dimension scale (EQ5D). Additionally, we asked about the patients' concerns and whether they felt improved, unchanged or deteriorated during the waiting period. RESULTS: Complete data were obtained for 110 (57%) patients, 59 and 51 awaiting knee or hip arthroplasty (median age 71 years, 62% were female), respectively. Arthroplasty was postponed for a median (range) 98 (63-161) days. A total of 34% were concerned that the postponement would lead to a poorer outcome. Mean OKS and OHS differences were 0 (95% confidence interval (CI): -1-1) and -1 (95% CI: -2-0) from surgery cancellation to re-scheduled surgery. The mean EQ5D index difference was 0.0 (95% CI: 0.0-0.1) for both groups. A total of 75 (68%) patients felt an important deterioration of their condition. CONCLUSIONS: Pre-operatively, patients worried about experiencing an altered treatment outcome due to postponed surgery and felt that their condition had deteriorated during the waiting period although this was not reflected in patient-reported outcome measures. FUNDING: Department of Orthopaedic Surgery. TRIAL REGISTRATION: not relevant.
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Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Osteoartritis de la Cadera , Anciano , Femenino , Humanos , Masculino , Osteoartritis de la Cadera/cirugía , Dolor , Medición de Resultados Informados por el PacienteRESUMEN
AIM: To quantify recruitment, retention and differential retention rates and associated trial, participant and intervention characteristics in randomised controlled trials (RCTs) evaluating the effect of exercise therapy in people with multimorbidity. DATA SOURCES: MEDLINE, EMBASE, CINAHL and CENTRAL from 1990 to April 20, 2020. STUDY SELECTION: RCTs including people with multimorbidity comparing exercise therapy with a non-exposed comparator group reporting at least one of the following outcomes: physical function, health-related quality of life, depression symptoms, or anxiety symptoms. DATA EXTRACTION AND SYNTHESIS: Recruitment rates (proportion of people randomised/proportion of people eligible), retention rates (proportion of people providing the outcomes of interest/proportion randomised) and differential retention rates (difference in proportion of people providing the outcomes in the intervention group and comparator group) were calculated. Meta-analysis using a random-effects model was used to estimate pooled proportions. Methodological quality was assessed using Cochrane ´Risk of Bias tool 2.0´ for individual studies, and the GRADE approach was used to assess the overall quality of the evidence. RESULTS: Twenty-three RCTs with 3363 people were included. The pooled prevalence for recruitment rate was 75% (95%CI 66 to 84%). The pooled prevalence for retention rate was 90% (95%CI 86 to 94%) at the end of the intervention (12 weeks; interquartile range (IQR) (12 to 12)). Meta-regression analyses showed that increasing age and including a higher proportion of people with hypertension was associated with lower retention rates. Retention rates did not differ between the intervention and comparator groups. The overall quality of the evidence was deemed very low. CONCLUSION: Three in four eligible people with multimorbidity were randomised to RCTs using exercise therapy, of which nine out of 10 provided end of treatment outcomes with no difference seen between the intervention and comparison groups. However, the results must be interpreted with caution due to large differences between the included studies. TRIAL REGISTRATION: ClinicalTrials.gov CRD42020161329 . Registered on 28 April 2020.
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Terapia por Ejercicio , Multimorbilidad , Ansiedad , Humanos , Terapias Mente-Cuerpo , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
OBJECTIVES: To investigate the benefits and harms of exercise therapy on physical and psychosocial health in people with multimorbidity. DESIGN: Systematic review of randomised controlled trials (RCTs). Data sources MEDLINE, EMBASE, CENTRAL and CINAHL from 1990 to April 20th, 2020 and Cochrane reviews on the effect of exercise therapy for each of the aforementioned conditions, reference lists of the included studies, the WHO registry and citation tracking on included studies in Web of Science. ELIGIBILITY CRITERIA FOR STUDY SELECTION: RCTs investigating the benefit of exercise therapy in people with multimorbidity, defined as two or more of the following conditions: osteoarthritis (of the knee or hip), hypertension, type 2 diabetes, depression, heart failure, ischemic heart disease, and chronic obstructive pulmonary disease on at least one of the following outcomes: Health-related quality of life (HRQoL), physical function, depression or anxiety. SUMMARY AND QUALITY OF THE EVIDENCE: Meta-analyses using a random-effects model to assess the benefit of exercise therapy and the risk of non-serious and serious adverse events according to the Food and Drug Administration definition. Meta-regression analyses to investigate the impact of pre-specified mediators of effect estimates. Cochrane 'Risk of Bias Tool' 2.0 and the GRADE assessment to evaluate the overall quality of evidence. RESULTS: Twenty-three RCTs with 3363 people, testing an exercise therapy intervention (mean duration 13.0 weeks, SD 4.0) showed that exercise therapy improved HRQoL (standardised mean difference (SMD) 0.37, 95 % CI 0.14 to 0.61) and objectively measured physical function (SMD 0.33, 95 % CI 0.17 to 0.49), and reduced depression symptoms (SMD -0.80, 95 % CI -1.21 to -0.40) and anxiety symptoms (SMD -0.49, 95 % CI -0.99 to 0.01). Exercise therapy was not associated with an increased risk of non-serious adverse events (risk ratio 0.96, 95 % CI 0.53-1.76). By contrast, exercise therapy was associated with a reduced risk of serious adverse events (risk ratio 0.62, 95 % CI 0.49 to 0.78). Meta-regression showed that increasing age was associated with lower effect sizes for HRQoL and greater baseline depression severity was associated with greater reduction of depression symptoms. The overall quality of evidence for all the outcomes was downgraded to low, mainly due to risk of bias, inconsistency and indirectness. CONCLUSIONS: Exercise therapy appears to be safe and to have a beneficial effect on physical and psychosocial health in people with multimorbidity. Although the evidence supporting this was of low quality, it highlights the potential of exercise therapy in the management and care of this population.
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Terapia por Ejercicio , Multimorbilidad , Ejercicio Físico , Humanos , Calidad de VidaRESUMEN
AIM: The aim of this study is to investigate the benefits and harms of therapeutic exercise in people with multimorbidity defined as the combination of two or more of the following conditions: knee and hip osteoarthritis, hypertension, diabetes type 2, depression, heart failure, ischaemic heart disease and chronic obstructive pulmonary disease, by performing a systematic review of randomized controlled trials (RCTs). METHODS: This study will be performed according to the recommendations from the Cochrane Collaboration and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). We will search for RCTs investigating the effect of therapeutic exercise in multimorbidity, as defined above, in MEDLINE, EMBASE, CENTRAL and CINAHL from 1990. Cochrane reviews on the effect of therapeutic exercise for each of the aforementioned conditions and references of the included studies will be checked for eligible studies and citation tracking will be performed in Web of Science. We will assess the risk of bias of the included studies using the Cochrane 'Risk of Bias Tool' 2.0 and the Grading of Recommendations Assessment, Development and Evaluation assessment for judging the overall quality of evidence. Meta-analyses will be performed, if possible, using a random-effects model as heterogeneity is expected due to differences in interventions and participant characteristics and outcome measures. Subgroup and meta-regression analyses will be performed to explore potential predictors of outcomes. DISSEMINATION: The results of this systematic review will be published in a peer-review journal, presented at national and international conferences and made available to end users via infographics, podcasts, press releases and videos.