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Background Magnetic resonance imaging (MRI) T2 and T1ρ relaxation are increasingly being proposed as imaging biomarkers potentially capable of detecting biochemical changes in articular cartilage before structural changes are evident. We aimed to: 1) summarize MRI methods of published studies investigating T2 and T1ρ relaxation time in participants at risk for but without radiographic knee OA; and 2) compare T2 and T1ρ relaxation between participants at-risk for knee OA and healthy controls. Methods We conducted a systematic review of studies reporting T2 and T1ρ relaxation data that included both participants at risk for knee OA and healthy controls. Participant characteristics, MRI methodology, and T1ρ and T2 relaxation data were extracted. Standardized mean differences (SMDs) were calculated within each study. Pooled effect sizes were then calculated for six commonly segmented knee compartments. Results 55 articles met eligibility criteria. There was considerable variability between scanners, coils, software, scanning protocols, pulse sequences, and post-processing. Moderate risk of bias due to lack of blinding was common. Pooled effect sizes indicated participants at risk for knee OA had lengthened T2 relaxation time in all compartments (SMDs from 0.33 to 0.74; p  < 0.01) and lengthened T1ρ relaxation time in the femoral compartments (SMD from 0.35 to 0.40; p  < 0.001). Conclusions T2 and T1ρ relaxation distinguish participants at risk for knee OA from healthy controls. Greater standardization of MRI methods is both warranted and required for progress towards biomarker validation.

Background The International Knee Documentation Committee Subjective Knee Form (IKDC) is the most highly recommended patient reported outcome measure for assessing patients with anterior cruciate ligament (ACL) injuries and those undergoing ACL reconstruction (ACLR) surgery. The IKDC was developed as a unidimensional instrument for a variety of knee conditions. Structural validity, which determines how an instrument is scored, has not been definitively confirmed for the IKDC in respondents with ACL injuries, and in fact an alternative two-factor/subscale structure has been proposed in this population. The purpose of this study was to determine the most appropriate structure and scoring system for the IKDC in young active patients following ACL injury. Methods In total, 618 young patients deemed at high risk of graft rupture were randomized into the Stability 1 trial. Of the trial participants, 606 patients (98%) completed a baseline IKDC questionnaire used for this analysis. A cross sectional retrospective secondary data analysis of the Stability 1 baseline IKDC data was completed to assess the structural validity of the IKDC using exploratory and confirmatory factor analyses. Factor analyses were used to test model fit of the intended one-factor structure, a two-factor structure, and alternative four-factor and bifactor structures (i.e., a combination of a unidimensional factor with additional specific factors) of the IKDC, in a dataset of young active ACL patients. Results The simple one-factor and two-factor structures of the IKDC displayed inadequate fit in our dataset of young ACL patients. A bifactor model provided the best fit. This model contains one general factor that is substantially associated with all items, plus four secondary, more specific content factors (symptoms, activity level, activities of daily living, and sport) with generally weaker associations to subsets of items. Although the single-factor model did not provide unambiguous support to unidimensionality of the IKDC based on fit indices, the bifactor model supports unidimensionality of the IKDC when covariance between items with similar linguistic structure, response options, or content are acknowledged. Conclusions Overall, findings of a bifactor model with evidence of a reliable general factor well defined by all items lends support to continue interpreting and scoring this instrument as unidimensional. This should be confirmed in other samples. Clinically, based on these findings, the IKDC can be represented by a single score for young active patients with ACL tears. A more nuanced interpretation would also consider secondary factors such as sport and activity level. Trial registration The Stability 1 trial for which these data were collected was registered on ClinicalTrial.gov (NCT02018354).

An important aim of high tibial osteotomy (HTO) is to prevent or delay the need for total knee replacement (TKR). We sought to estimate the frequency and timing of conversion from HTO to TKR and the factors associated with it. We prospectively evaluated patients with osteoarthritis (OA) of the knee who underwent medial opening wedge HTO from 2002 to 2014 and analyzed the cumulative incidence of TKR in July 2019. The presence or absence of TKR on the HTO limb was identified from the orthopedic surgery reports and knee radiographs contained in the electronic medical records for each patient at London Health Sciences Centre. We used cumulative incidence curves to evaluate the primary outcome of time to TKR. We used multivariable Cox proportional hazards analysis to assess potential preoperative predictors including radiographic disease severity, malalignment, correction size, pain, sex, age, body mass index (BMI) and year of surgery. Among 556 patients who underwent 643 HTO procedures, the cumulative incidence of TKR was 5% (95% confidence interval [CI] 3%–7%) at 5 years and 21% (95% CI 17%–26%) at 10 years. With the Cox proportional hazards multivariable model, the following preoperative factors were significantly associated with an increased rate of conversion: radiographic OA severity (adjusted hazard ratio [HR] 1.96, 95% CI 1.12–3.45), pain (adjusted HR 0.85, 95% CI 0.75–0.96)], female sex (adjusted HR 1.67, 95% CI 1.08–2.58), age (adjusted HR 1.50 per 10 yr, 95% CI 1.17–1.93) and BMI (adjusted HR 1.31 per 5 kng/m2, 95% CI 1.12–1.53). We found that 79% of knees did not undergo TKR within 10 years after undergoing medial opening wedge HTO. The strongest predictor of conversion to TKR is greater radiographic disease at the time of HTO.

L’un des importants objectifs de l’ostéotomie tibiale haute (OTH) est de prévenir ou de retarder le recours à l’arthroplastie totale du genou (ATG). Nous avons voulu estimer la fréquence et le moment de la conversion de l’OTH vers l’ATG et dégager les facteurs associés. Nous avons évalué de manière prospective les patients atteints d’arthrose du genou, ou gonarthrose, ayant subi une OTH de valgisation par ouverture médiale entre 2002 et 2014 et nous avons analysé l’incidence cumulative des ATG en date de juillet 2019. La présence ou l’absence d’une ATG impliquant le membre soumis à l’OTH a été déterminée à partir des notes de chirurgie orthopédique et des rapports de radiographie des genoux versés au dossier médical électronique de chaque patient du Centre des sciences de la santé de London. Nous avons utilisé des courbes d’incidence cumulative pour évaluer le paramètre principal, soit le temps écoulé avant l’ATG. Nous avons effectué une analyse multivariée à risques proportionnels de Cox pour évaluer les prédicteurs préopératoires potentiels, y compris la gravité de la maladie à la radiographie, le désalignement, l’ampleur de la correction, la douleur, le sexe, l’âge, l’indice de masse corporelle (IMC) et l’année de la chirurgie. Sur 556 patients ayant subi 643 OTH, l’incidence cumulative des ATG était de 5 % (intervalle de confiance [IC] à 95 % 3 %–7 %) à 5 ans et de 21 % (IC à 95 % 17 %–26 %) à 10 ans. Avec le modèle multivarié à risques proportionnels de Cox, les facteurs préopératoires suivants ont été significativement associés à une augmentation du taux de conversion: gravité de l’arthrose à la radiographie (risque relatif [RR] ajusté 1,96; IC à 95 % 1,12–3,45), douleur (RR ajusté 0,85; IC à 95 % 0,75–0,96), sexe féminin (RR ajusté 1,67; IC à 95 % 1,08–2,58), âge (RR ajusté 1,50 par tranche de 10 ans; IC à 95 % 1,17–1,93) et IMC (RR ajusté 1,31 par tranche de 5 kg/m2; IC à 95 % 1,12–1,53). Nous avons constaté que 79 % des genoux n’ont pas nécessité une ATG dans les 10 années suivant l’OTH de valgisation par ouverture médiale. Le plus solide prédicteur de la conversion vers l’ATG était la gravité de la maladie à la radiographie faite au moment de l’OTH.

Background The shortened version of the Western Ontario Rotator Cuff Index (Short-WORC) is a patient reported outcome measure that evaluates quality of life (QoL) of patients with rotator cuff pathology. However, formal content validation of the full or Short-WORC has not been reported. This study aims to understand how 1) people interpret and calibrate responses to items on the Short-WORC and 2) compensatory strategies that might enhance function and thereby affect responses. Methods This study uses cognitive interviewing, a qualitative methodology that focuses on the interpretation of questionnaire items. Patients with rotator cuff disorders ( n  = 10), clinicians ( n  = 6) and measurement researchers (n = 10) were interviewed using a talk aloud structured interview that evaluated each of the 7 items of the Short-WORC. All interviews were recorded and transcribed verbatim by one researcher (R.F). Analysis was done through an open coding scheme using a previously established framework. Results Overall, the items on the Short-WORC were well received by participants. Through the interviews, the 6 themes of: Comprehension, Inadequate response definition, Reference Point, Relevance, Perspective Modifiers and Calibration Across Items emerged. The items of working above the shoulder (90%), compensating with the unaffected arm (88%) and lifting heavy objects (92%) were the most relevant to participants. Participants calibrated their scores on the items of sleeping and styling (19%) the most. Perspective modifiers of gender, influenced the calibrations of items of styling your hair (30%) and dressing or undressing (19%). Compensatory strategies of task-re allocation and using assistive devices/resources were frequently mentioned by participants. Overall, participants had minor comprehension issues, but found the 7- items of the Short-WORC to be relevant to QoL. Conclusions Therefore, the findings demonstrate that the Short-WORC is not cognitively complex, but varies with patient perspectives. Overall, the Short-WORC provides evidence of demonstrating strong content validity when used for rotator cuff disorder patients.

Background To evaluate the translations, cross-cultural adaptation procedures and measurement properties of the Western Ontario Rotator Cuff Index (WORC), when it is adapted for different cultures. Methods A systematic review was performed, considering different cultural adaptions of the WORC accessible through MEDLINE, CINAHL, EMBASE and/or Google Scholar. Included were prospective cohort studies that used an adapted version of the WORC to measure QoL in patients with rotator cuff disorders. All studies were evaluated according to the current guidelines for cross-cultural adaptations and measurement properties. Results The search retrieved 14 studies that met the inclusion criteria. According to the recommended guidelines for cross-cultural adaptations, 8 studies performed 100% of the steps, 2 studies performed 80% of the steps and 4 studies used previously translated measures. When evaluating the studies’ psychometric properties based on the quality criteria, none of the studies reported all recommended measurement properties. All of the studies reported the measurement property of reliability, but none of the studies reported agreement. Internal consistency was fully reported by 15% of studies. Construct validity was reported by 43% of studies. Only one study reported 100% of the cross-cultural adaption guidelines and 83% of the quality criteria. Conclusions Although the majority of studies demonstrated proper adaptation procedures, testing of the measurement properties were inadequate. It is recommended that the current adapted versions of the WORC undergo further testing before use in clinical practise, and researchers continue to adapt the WORC for different cultures as it proves to be an appropriate instrument for assessing rotator cuff pathology.

Background A significant proportion of the overall cost of total hip arthroplasty (THA) results from the inpatient hospital stay following the procedure. Considering the substantial and increasing number of these procedures performed annually, shifting to an outpatient model of care where the patient is discharged home the same day as their surgery represents a potential for significant cost savings. The potential significant impact of an outpatient care model on constrained healthcare budgets and lack of high-quality evidence regarding its effectiveness warrants a rigorous comparative trial. The purpose of this prospective, randomized controlled trial is to evaluate outpatient care pathways for THA. Specifically, our objectives are to compare the rate of serious adverse events and estimate the cost-effectiveness of outpatient compared to standard inpatient THA. Methods We will include patients undergoing primary THA whom have an American Society of Anaesthetists status equal to or less than three, live within a 60-min driving distance of the institution and have an adult to accompany them home postoperatively and stay with them overnight. Consenting patients will be randomized to be discharged on the same day as surgery, as outpatients, or as inpatients according to standard of care (minimum of one night in hospital) using a modified Zelen consent model. The primary outcome measure is the incidence of serious adverse events at 30 days postoperative. Participants and their caregivers will complete secondary outcomes measures at each follow-up visit including patient-reported outcome measures and self-reported cost questionnaires. Discussion This protocol is the first randomized trial to use blinding to evaluate outpatient THA compared to standard overnight stay and first to prospectively perform a full economic evaluation. It is also the first adequately powered trial to prospectively assess the safety of outpatient THA. Successful completion of this study could have the potential to provide clinical evidence for the role of outpatient THA in current practice. Trial registration This study was retrospectively registered on ClinicalTrials.gov ( NCT03026764 ) on March 9th, 2016.

IntroductionOver 777 million COVID-19 infections have occurred globally, with data suggesting that 10%–20% of those infected develop Long COVID. Fatigue is one of the most common and disabling symptoms of Long COVID. We aim to assess the feasibility and safety of a new, remotely delivered, multimodal rehabilitation intervention, paced to prevent post-exertional malaise (PEM), to support the conduct of a future, definitive randomised trial.Methods and analysisWe will conduct a randomised, two-arm feasibility trial (COVIDEx intervention vs usual care). Sixty participants with Long COVID will be recruited and randomised prior to giving informed consent under a modified Zelen design using 1:1 allocation with random permuted blocks via central randomisation to receive either the COVIDEx intervention or usual care. The 50-minute, remotely delivered, COVIDEx intervention will occur twice weekly for 8 weeks. All participants will wear a non-invasive device throughout their entire study participation, to track heart rate, blood oxygen saturation, steps, sleep and monitor PEM. The primary feasibility objectives will be recruitment rates, intervention fidelity, adherence, acceptability (intervention and design), retention, blinding success and outcome completeness. Secondary objectives will include refined estimates for the standard deviation and correlation between baseline and follow-up measurements of fatigue. Feasibility and clinical outcomes will be collected at baseline, 4, 8, 12 and 24 weeks. Qualitative interviews with participants and physiotherapists will explore intervention acceptability and barriers/facilitators.Ethics and disseminationEthical approval for this study was obtained by the Western University Health Sciences Research Ethics Board (REB# 123902). Dissemination plans include sharing of trial findings at conferences and through open access publications and patient/community channels.Trial registration numberNCT06156176

To explore the theory of response shift in young athletes undergoing anterior cruciate ligament (ACL) reconstruction (ACLR) by investigating athletes’ conceptualisation of quality of life (QOL) across time following ACL injury. A mixed-methods study was conducted to understand young athletes’ perceived QOL through qualitative investigation of participant perspectives and quantitative self-reported QOL ratings. 20 young athletes were purposively sampled for semi-structured interviews at two timepoints: preoperatively following ACL injury, and 1 year after ACLR. During the interviews, participants also reported their QOL on a visual analogue scale from 0 to 100. Transcripts were coded by two independent researchers. Descriptive quantitative analyses of QOL ratings and thematic analysis of qualitative data were conducted to identify mechanisms of response shift. Self-reported ratings of QOL indicated a recalibration response shift. When recalled preoperative scores were used in place of actual preoperative ratings, improvement in self-reported QOL was larger (median change: 13, range −6 to 62 vs median change: 29, range 5 to 75, respectively). Postoperatively, three processes of reprioritisation related to sport were identified within 16 interviews 1 year after surgery: (1) early transition away from sport as a priority, (2) expected transition away from sport as a priority and (3) sport preserved as a priority. Athletes’ perception of overall QOL was influenced by the use of various coping strategies and engagement in self-reflection. QOL does not mean the same things to athletes before and after ACLR, and conceptualisations of QOL are influenced by complex factors. True change in patient-reported outcomes cannot be validly measured if the definitions of constructs are changing. We propose the SPARQ ACL Model of Sport Prioritisation and Athlete Reconceptualisation of Quality of life following ACL injury and reconstruction to help understand these changes.

To investigate the rationale, potential problems and solutions of using composite endpoints (CEPs) for the assessment of intervention effects. This study is a systematic review. We searched MEDLINE, EMBASE, and the Science Citation Index, for publications appearing between 1980 and September 2005, and reviewed potentially informative textbooks. Eligible articles provided a commentary, analysis, or discussion of CEPs for any of the following areas: (1) rationale, (2) interpretation or meaning, (3) advantages, (4) limitations or conceptual problems, and (5) recommendations for use. Seventeen articles and one textbook proved eligible. Decreases in sample size requirements and ability to assess the net effect of an intervention were the most commonly cited advantages. Authors noted the risk of misinterpretation when heterogeneity among components with respect to either patient importance or magnitude of treatment effects as the most salient disadvantage. There were discrepancies between authors concerning the usefulness of CEPs to avoid bias from competing risks and when the direction of the effect of therapy differs across components. Methodologists have given limited attention to CEPs and their views are sometimes contradictory. Further work is needed to establish the role of CEPs in research and in guiding clinical practice.