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Purpose: This study aimed to (1) analyze the Coronal Plane Alignment of the Knee (CPAK) classification in patients undergoing unicompartmental knee arthroplasty (UKA), (2) assess whether UKA can restore pre-arthritic coronal alignment by utilizing the arithmetic hip-knee-ankle angle (aHKA), and (3) evaluate the relationship between patient-reported outcome measures (PROMs) and postoperative alignment following UKA. Methods: We retrospectively analyzed 152 consecutive patients who underwent fixed-bearing medial UKA. A radiological analysis was conducted using an EOS imaging system. Postoperative alignment was classified as neutral (varus ≤ 3°), mild varus (3° < varus ≤ 7°), or marked varus (varus > 7°) based on the mechanical hip-knee-ankle angle (mHKA). The aHKA was calculated and the CPAK classification was used to categorize knee phenotypes. The PROMs were obtained both before and after the surgery. Results: A total of 152 knees from 113 patients were included with a mean two-year follow-up. The mean difference between the postoperative mHKA and the estimated aHKA was 0.80° (90% CI 0.35 to 1.24; P = 0.003). Postoperatively, 63 (41.45%) of the 152 knees were in neutral group, 54 (35.53%) mild varus, and 35 (23.03%) marked varus. The neutrally aligned cohort did not exhibit significantly higher scores in range of motion, VAS, HSS, WOMAC, or FJS-12 scores compared to the mild or marked varus cohort (P = 0.205, 0.118, 0.076, 0.140, and 0.788, respectively) during the short-term follow-up. Conclusion: Non-robotically assisted, fixed-bearing medial UKA can restore pre-arthritic coronal alignment and achieve satisfactory PROMs. Fixed-bearing medial UKA aims to restore the pre-arthritic alignment rather than achieving neutral mechanical alignment. [ABSTRACT FROM AUTHOR]

ABSTRACT Background Objective Search Strategy Selection Criteria Data Collection and Analysis Main Results Conclusion Patient‐reported outcome measures (PROMs) are recommended to measure the impact of a health condition or intervention effectiveness as they aim to capture what is most meaningful to patients. Several PROMs are used to evaluate pelvic organ prolapse (POP)‐related domains, yet the measurement properties of these instruments have not been fully explored with a rigorous analysis of the methodological quality and quality of evidence.To conduct a systematic review reporting on the measurement properties of PROMs used for the assessment of POP‐related domains in accordance with the COSMIN guidelines.Five databases were searched from inception to December 2023.Studies were eligible if they involved (1) at least one group of female adults diagnosed with or presenting with symptoms of POP; (2) a self‐reported outcome measure (PROMs, questionnaires) to evaluate POP‐related domains; and (3) at least one measurement property.Methodological quality and measurement quality were assessed using the COSMIN risk of bias (ROB) checklist and the COSMIN criteria for good measurement properties.A total of 13 PROMs were included. The BIPOP had the lowest ROB for Content Validity. The POP‐SS was the only PROM with sufficient evidence of adequate construct validity and responsiveness to be used in both surgical and conservative management settings.This original work identified a gap in evidence regarding the measurement qualities of identified PROMs used in the POP population. [ABSTRACT FROM AUTHOR]

Background: Isokinetic torque in shoulder internal rotation (IR) and external rotation (ER) can be considered as potential indicators for dynamic stability of the glenohumeral joint. Purpose: To assess the efficacy of 4-month isokinetic testing in predicting the 6-month return-to-sports (RTS) status after Latarjet surgery, explore its correlations with testing parameters, and identify optimal thresholds to ensure a safe RTS. Study Design: Cohort study; Level of evidence, 2. Methods: The study assessed athletes who underwent the Latarjet stabilization procedure between January 2022 and June 2023. The primary outcome was RTS at 6 months after surgery. The primary examined predictors were isokinetic testing metrics at 4 months postoperatively. Secondary outcomes comprised the modified Closed Kinetic Chain Upper Extremity Stability Test (mCKCUEST) and several patient-reported outcome measures, including the Walch-Duplay score, the Western Ontario Shoulder Instability Index (WOSI), and the Shoulder Instability–Return to Sports after Injury scale. To assess the predictors, patients were divided into those who returned to any level of sports compared with those who did not return to sports. The correlation between isokinetic testing results and other outcome scores was also analyzed. Results: A total of 71 patients (mean age, 27.43 ± 9.09 years) were included in the study. Of these, 23.61% did not return to sports, 38.89% returned at a lower level, and 37.50% returned to the same level. Significant rotational strength disparities were noted. Patients who did not return to sports at 6 months demonstrated inferior strength in concentric ER at 60 deg/s, concentric ER at 240 deg/s, concentric IR at 240 deg/s, and eccentric IR at 30 deg/s (P <.05). Similar trends appeared for all studied patient-reported outcome measures and the mCKCUEST (P <.05). Receiver operating characteristic analysis emphasized the significance of isokinetic testing in concentric ER at 240 deg/s (area under the curve = 0.759; P =.001; cutoff = 0.32 N·m/kg; sensitivity = 100.0%; specificity = 49.1%) and eccentric ER at 30 deg/s (area under the curve = 0.760; P =.001; cutoff = 0.51 N·m/kg; sensitivity = 94.1%; specificity = 49.1%) for RTS prediction. Additionally, ER strength moderately correlated with the Walch-Duplay score across all examined velocities (r = 0.26-0.34; P <.05). The modified WOSI score was weakly linked to ER strength at 240 deg/s and 30 deg/s (r = 0.24-0.25; P <.05) as well as moderately linked to the limb symmetry index in ER at 60 deg/s and 30 deg/s (r = 0.30-0.38; P <.05). Conclusion: Isokinetic testing can act as an independent predictor of successful RTS after Latarjet surgery, with concentric ER at 240 deg/s, concentric IR at 240 deg/s, eccentric ER at 30 deg/s, and eccentric IR at 30 deg/s showing the most accuracy. Strength recovery in ER was associated with better Walch-Duplay and modified WOSI scores. [ABSTRACT FROM AUTHOR]

Purpose: To establish a psychometric validated pelvic fracture-urethral injury postoperative erectile function patient reported outcome measure (PFUI pEF PROM). We also aim to explore PFUI patients' potential classification and suitable postoperative erectile function assessment pattern. Methods: A total of 93 PFUI patients who treated by excision and primary anastomotic (EPA) urethroplasty from January 2020 to August 2022 were enrolled to this study. Patients who had intercourse completed the IIEF-5, those who had sexual stimulation other than intercourse finished PFUI pEF PROM, and those who performed both completed the IIEF-5, and PFUI pEF PROM. Erection Hardness Score (EHS) was completed by all patients. This PROM was performed psychometric validation and used to find PFUI patients potential classification through latent class analysis. Then, we determined the cut-off value though receiver-operating characteristic (ROC) curve and performed univariate analysis subgroups feature. Results: The PFUI pEF PROM demonstrated high reliability and validity with a Cronbach's alpha of 0.928. It correlated significantly with IIEF-5 (r = 0.550, p < 0.001) and EHS (r = 0.909, p < 0.001). The latent class analysis identified three patient subgroups, with 14.5 as the subgroup cut-off value. Urethral stricture length, IIEF-5, and EHS score were identified as influence factors for maximal erection potential. An assessment pattern combining IIEF-5, EHS, and the PFUI pEF PROM covered 92.5% of patients. Conclusion: This PROM effectively addresses the current limitation in assessing erectile function in PFUI patients. This study provides a promising tool for stratified assessment, prediction erection recovery, and treatment guidance in the PFUI Erectile dysfunction field. [ABSTRACT FROM AUTHOR]

Aims: The Single Assessment Numerical Evalution (SANE) score is a pragmatic alternative to longer patient-reported outcome measures (PROMs). The purpose of this study was to investigate the concurrent validity of the SANE and hip-specific PROMs in a generalized population of patients with hip pain at a single timepoint upon initial visit with an orthopaedic surgeon who is a hip preservation specialist. We hypothesized that SANE would have a strong correlation with the 12-question International Hip Outcome Tool (iHOT)-12, the Hip Outcome Score (HOS), and the Hip disability and Osteoarthritis Outcome Score (HOOS), providing evidence for concurrent validity of the SANE and hip-specific outcome measures in patients with hip pain. Methods: This study was a cross-sectional retrospective database analysis at a single timepoint. Data were collected from 2,782 patients at initial evaluation with a hip preservation specialist using the iHOT-12, HOS, HOOS, and SANE. Outcome scores were retrospectively analyzed using Pearson correlation coefficients. Results: Mean raw scores were iHOT-12 67.01 (SD 29.52), HOS 58.42 (SD 26.26), HOOS 86.85 (SD 32.94), and SANE 49.60 (SD 27.92). SANE was moderately correlated with the iHOT-12 (r = -0.4; 95% CI -0.35 to -0.44; p < 0.001), HOS (r = 0.57; 95% CI 0.53 to 0.60; p < 0.001), and HOOS (r = -0.55; 95% CI -0.51 to -0.58; p < 0.001). The iHOT-12 and HOOS were recorded as a lower score, indicating better function, which accounts for the negative r values. Conclusion: This study was the first to investigate the relationship between the SANE and the iHOT-12, HOS, and HOOS in a population of patients with hip pain at the initial evaluation with an orthopaedic surgeon, and found moderate correlation between SANE and the iHOT-12, HOS, and HOOS. The SANE may be a pragmatic alternative for clinical benchmarking in a general population of patients with hip pain. The construct validity of the SANE should be questioned compared to legacy measures whose content validity has been more rigorously investigated. Cite this article: Bone Jt Open 2024;5(10):904–910.

Aims: The aim of this study was to determine whether obesity had a detrimental effect on the long-term performance and survival of medial unicompartmental knee arthroplasties (UKAs). Methods: This study reviewed prospectively collected functional outcome scores and revision rates of all medial UKA patients with recorded BMI performed in Christchurch, New Zealand, from January 2011 to September 2021. Patient-reported outcome measures (PROMs) were the primary outcome of this study, with all-cause revision rate analyzed as a secondary outcome. PROMs were taken preoperatively, at six months, one year, five years, and ten years postoperatively. There were 873 patients who had functional scores recorded at five years and 164 patients had scores recorded at ten years. Further sub-group analysis was performed based on the patient’s BMI. Revision data were available through the New Zealand Joint Registry for 2,323 UKAs performed during this time period. Results: Obese patients (BMI > 30 kg/m2) were 3.1 years younger than non-obese patients (BMI < 30 kg/m2) at the time of surgery (mean age of obese patients 65.5 years (SD 9.7) and mean age of non-obese patients 68.6 years (SD 10.1)). Preoperatively, obese patients tended to have significantly lower functional scores than non-obese patients, which continued at five and ten years postoperatively. At these timepoints, obese patients had significantly lower scores for most PROMs measured compared to non-obese patients. However, there was no significant difference in the improvement of any of these scores after surgery between obese and non-obese patients. There was no significant difference in revision rates between obese and non-obese patients at any time. All-cause revision rate for obese patients was 0.73 per 100 observed component years compared to 0.67 in non-obese patients at ten years. There was also no significant difference in the aseptic loosening rate between groups. Conclusion: Our study supports the use of UKAs in obese patients, with similar benefit and survival compared to non-obese patients at ten years.

Abstract Purpose This study aimed to (1) analyze the Coronal Plane Alignment of the Knee (CPAK) classification in patients undergoing unicompartmental knee arthroplasty (UKA), (2) assess whether UKA can restore pre-arthritic coronal alignment by utilizing the arithmetic hip-knee-ankle angle (aHKA), and (3) evaluate the relationship between patient-reported outcome measures (PROMs) and postoperative alignment following UKA. Methods We retrospectively analyzed 152 consecutive patients who underwent fixed-bearing medial UKA. A radiological analysis was conducted using an EOS imaging system. Postoperative alignment was classified as neutral (varus ≤ 3°), mild varus (3° < varus ≤ 7°), or marked varus (varus > 7°) based on the mechanical hip-knee-ankle angle (mHKA). The aHKA was calculated and the CPAK classification was used to categorize knee phenotypes. The PROMs were obtained both before and after the surgery. Results A total of 152 knees from 113 patients were included with a mean two-year follow-up. The mean difference between the postoperative mHKA and the estimated aHKA was 0.80° (90% CI 0.35 to 1.24; P = 0.003). Postoperatively, 63 (41.45%) of the 152 knees were in neutral group, 54 (35.53%) mild varus, and 35 (23.03%) marked varus. The neutrally aligned cohort did not exhibit significantly higher scores in range of motion, VAS, HSS, WOMAC, or FJS-12 scores compared to the mild or marked varus cohort (P = 0.205, 0.118, 0.076, 0.140, and 0.788, respectively) during the short-term follow-up. Conclusion Non-robotically assisted, fixed-bearing medial UKA can restore pre-arthritic coronal alignment and achieve satisfactory PROMs. Fixed-bearing medial UKA aims to restore the pre-arthritic alignment rather than achieving neutral mechanical alignment.

Aims: Patient dissatisfaction following primary total knee arthroplasty (TKA) with manual jig-based instruments has been reported to be as high as 30%. Robotic-assisted total knee arthroplasty (RA-TKA) has been increasingly used in an effort to improve patient outcomes, however there is a paucity of literature examining patient satisfaction after RA-TKA. This study aims to identify the incidence of patients who were not satisfied following RA-TKA and to determine factors associated with higher levels of dissatisfaction. Methods: This was a retrospective review of 674 patients who underwent primary TKA between October 2016 and September 2020 with a minimum two-year follow-up. A five-point Likert satisfaction score was used to place patients into two groups: Group A were those who were very dissatisfied, dissatisfied, or neutral (Likert score 1 to 3) and Group B were those who were satisfied or very satisfied (Likert score 4 to 5). Patient demographic data, as well as preoperative and postoperative patient-reported outcome measures, were compared between groups. Results: Overall, 45 patients (6.7%) were in Group A and 629 (93.3%) were in Group B. Group A (vs Group B) had a higher proportion of male sex (p = 0.008), preoperative chronic opioid use (p < 0.001), preoperative psychotropic medication use (p = 0.01), prior anterior cruciate ligament (ACL) reconstruction (p < 0.001), and preoperative symptomatic lumbar spine disease (p = 0.004). Group A was also younger (p = 0.023). Multivariate analysis revealed preoperative opioid use (p = 0.012), prior ACL reconstruction (p = 0.038), male sex (p = 0.006), and preoperative psychotropic medication use (p = 0.001) as independent predictive factors of patient dissatisfaction. Conclusion: The use of RA-TKA demonstrated a high rate of patient satisfaction (629 of 674, 93.3%). Demographics for patients not satisfied following RA-TKA included: male sex, chronic opioid use, chronic psychotropic medication use, and prior ACL reconstruction. Patients in these groups should be identified preoperatively and educated on realistic expectations given their comorbid conditions. Cite this article: Bone Jt Open 2024;5(9):758–765.

Aims: It is well described that patients with bone and joint infections (BJIs) commonly experience significant functional impairment and disability. Published literature is lacking on the impact of BJIs on mental health. Therefore, the aim of this study was to assess health-related quality of life (HRQoL) and the impact on mental health in patients with BJIs. Methods: The AO Trauma Infection Registry is a prospective multinational registry. In total, 229 adult patients with long-bone BJI were enrolled between 1 November 2012 and 31 August 2017 in 18 centres from ten countries. Clinical outcome data, demographic data, and details on infections and treatments were collected. Patient-reported outcomes using the 36-Item Short-Form Health Survey questionnaire (SF-36), Parker Mobility Score, and Katz Index of Independence in Activities of Daily Living were assessed at one, six, and 12 months. The SF-36 mental component subscales were analyzed and correlated with infection characteristics and clinical outcome. Results: The SF-36 physical component summary mean at baseline was 30.9 (95% CI 29.7 to 32.0). At one month, it was unchanged (30.5; 95% CI 29.5 to 31.5; p = 0.447); it had improved statistically significantly at six months (35.5; 95% CI 34.2 to 36.7; p < 0.001) and at 12 months (37.9; 95% CI 36.4 to 39.3; p < 0.001). The SF-36 mental component summary mean at baseline was 42.5 (95% CI 40.8 to 44.2). At one month, it was unchanged (43.1; 95% CI 41.4 to 44.8; p = 0.458); it had improved statistically significantly at six months (47.1; 95% CI 45.4 to 48.7; p < 0.001) and at 12 months (46.7; 95% CI 45.0 to 48.5; p < 0.001). All mental subscales had improved by the end of the study, but mental health status remained compromised in comparison with the average USA population. Conclusion: BJIs considerably impact HRQoL, particularly mental health. Patients suffering from BJIs reported considerable limitations in their daily and social activities due to psychological problems. Impaired mental health may be explained by the chronic nature of BJIs, and therefore the mental wellbeing of these patients should be monitored closely. Cite this article: Bone Jt Open 2024;5(9):721–728.

Aims: The paediatric trigger thumb is a distinct clinical entity with unique anatomical abnormalities. The aim of this study was to present the long-term outcomes of A1 pulley release in idiopathic paediatric trigger thumbs based on established patient-reported outcome measures. Methods: This study was a cross-sectional, questionnaire-based study conducted at a tertiary care orthopaedic centre. All cases of idiopathic paediatric trigger thumbs which underwent A1 pulley release between 2004 and 2011 and had a minimum follow-up period of ten years were included in the study. The abbreviated version of the Disabilities of Arm, Shoulder and Hand questionnaire (QuickDASH) was administered as an online survey, and ipsi- and contralateral thumb motion was assessed. Results: A total of 67 patients completed the survey, of whom 63 (94%) had full interphalangeal joint extension or hyperextension. Severe metacarpophalangeal joint hyperextension (> 40°) was documented in 15 cases (22%). The median QuickDASH score was 0 (0 to 61), indicating excellent function at a median follow-up of 15 years (10 to 19). Overall satisfaction was high, with 56 patients (84%) reporting the maximal satisfaction score of 5. Among 37 patients who underwent surgery at age ≤ two years, 34 (92%) reported the largest satisfaction, whereas this was the case for 22 of 30 patients (73%) with surgery at aged > two years (p = 0.053). Notta’s nodule resolved in 49 patients (73%) at final follow-up. No residual triggering or revision surgery was observed. Conclusion: Surgical release of A1 pulley in paediatric trigger thumb is an acceptable procedure with excellent functional long-term outcomes. There was a trend towards higher satisfaction with earlier surgery among the patients. Cite this article: Bone Jt Open 2024;5(9):736–741.

Aims: The Oxford Shoulder Score (OSS) is a 12-item measure commonly used for the assessment of shoulder surgeries. This study explores whether computerized adaptive testing (CAT) provides a shortened, individually tailored questionnaire while maintaining test accuracy. Methods: A total of 16,238 preoperative OSS were available in the National Joint Registry (NJR) for England, Wales, Northern Ireland, the Isle of Man, and the States of Guernsey dataset (April 2012 to April 2022). Prior to CAT, the foundational item response theory (IRT) assumptions of unidimensionality, monotonicity, and local independence were established. CAT compared sequential item selection with stopping criteria set at standard error (SE) < 0.32 and SE < 0.45 (equivalent to reliability coefficients of 0.90 and 0.80) to full-length patient-reported outcome measure (PROM) precision. Results: Confirmatory factor analysis (CFA) for unidimensionality exhibited satisfactory fit with root mean square standardized residual (RSMSR) of 0.06 (cut-off ≤ 0.08) but not with comparative fit index (CFI) of 0.85 or Tucker-Lewis index (TLI) of 0.82 (cut-off > 0.90). Monotonicity, measured by H value, yielded 0.482, signifying good monotonic trends. Local independence was generally met, with Yen’s Q3 statistic > 0.2 for most items. The median item count for completing the CAT simulation with a SE of 0.32 was 3 (IQR 3 to 12), while for a SE of 0.45 it was 2 (IQR 2 to 6). This constituted only 25% and 16%, respectively, when compared to the 12-item full-length questionnaire. Conclusion: Calibrating IRT for the OSS has resulted in the development of an efficient and shortened CAT while maintaining accuracy and reliability. Through the reduction of redundant items and implementation of a standardized measurement scale, our study highlights a promising approach to alleviate time burden and potentially enhance compliance with these widely used outcome measures. Cite this article: Bone Joint Res 2024;13(8):392–400.

Aims: To systematically review the predominant complication rates and changes to patient-reported outcome measures (PROMs) following osteochondral allograft (OCA) transplantation for shoulder instability. Methods: This systematic review, following PRISMA guidelines and registered in PROSPERO, involved a comprehensive literature search using PubMed, Embase, Web of Science, and Scopus. Key search terms included “allograft”, “shoulder”, “humerus”, and “glenoid”. The review encompassed 37 studies with 456 patients, focusing on primary outcomes like failure rates and secondary outcomes such as PROMs and functional test results. Results: A meta-analysis of primary outcomes across 17 studies revealed a dislocation rate of 5.1% and an increase in reoperation rates from 9.3% to 13.7% post-publication bias adjustment. There was also a noted rise in conversion to total shoulder arthroplasty and incidence of osteoarthritis/osteonecrosis over longer follow-up periods. Patient-reported outcomes and functional tests generally showed improvement, albeit with notable variability across studies. A concerning observation was the consistent presence of allograft resorption, with rates ranging from 33% to 80%. Comparative studies highlighted similar efficacy between distal tibial allografts and Latarjet procedures in most respects, with some differences in specific tests. Conclusion: OCA transplantation presents a promising treatment option for shoulder instability, effectively addressing both glenoid and humeral head defects with favourable patient-reported outcomes. These findings advocate for the inclusion of OCA transplantation in treatment protocols for shoulder instability, while also emphasizing the need for further high-quality, long-term research to better understand the procedure’s efficacy profile. Cite this article: Bone Jt Open 2024;5(7):570–580.

Aims: The primary aim of this study was to assess the feasibility of recruiting and retaining patients to a patient-blinded randomized controlled trial comparing corticosteroid injection (CSI) to autologous protein solution (APS) injection for the treatment of subacromial shoulder pain in a community care setting. The study focused on recruitment rates and retention of participants throughout, and collected data on the interventions’ safety and efficacy. Methods: Participants were recruited from two community musculoskeletal treatment centres in the UK. Patients were eligible if aged 18 years or older, and had a clinical diagnosis of subacromial impingement syndrome which the treating clinician thought was suitable for treatment with a subacromial injection. Consenting patients were randomly allocated 1:1 to a patient-blinded subacromial injection of CSI (standard care) or APS. The primary outcome measures of this study relate to rates of recruitment, retention, and compliance with intervention and follow-up to determine feasibility. Secondary outcome measures relate to the safety and efficacy of the interventions. Results: A total of 53 patients were deemed eligible, and 50 patients (94%) recruited between April 2022 and October 2022. Overall, 49 patients (98%) complied with treatment. Outcome data were collected in 100% of participants at three months and 94% at six months. There were no significant adverse events. Both groups demonstrated improvement in patient-reported outcome measures over the six-month period. Conclusion: Our study shows that it is feasible to recruit to a patient-blinded randomized controlled trial comparing APS and CSI for subacromial pain in terms of clinical outcomes and health-resource use in the UK. Safety and efficacy data are presented. Cite this article: Bone Jt Open 2024;5(7):534–542.

Abstract Background There has long been discussion regarding the impact of medial malleolar osteotomies (MMO) as an adjunctive treatment for osteochondral lesions of the talus (OCLT). MMO may improve the visibility and accessibility of the talus, but they also pose a risk of periprocedural morbidity. There is a lack of research about the prevalence and consequences of MMO in the surgical treatment of OCLT. Methods This study retrospectively evaluated data from the German Cartilage Register (KnorpelRegister DGOU) from its implementation in 2015 to December 2020. The impact of MMO on patient-reported outcome measures (PROMs) was investigated. Wherever possible, subgroups were built and matched using a propensity score which matched a group undergoing OCLT without MMO. Matching included age, sex, weight, localization of the OCLT, the international cartilage repair society (ICRS) grading, surgical procedure and preoperative symptoms using the Foot and Ankle Ability Measure (FAAM) and the Activities of Daily Living Subscale (ADL). Results The prevalence of MMO in the operative treatment of OCLT was 15.9%. Most of the osteotomies were performed in OCL of the medial talar dome (76.8%) and in more serious lesions with an ICRS grade of III (29.1%) and IV (61.4%). More than half of the osteotomies (55.6%) were performed during revision surgery. A matched pair analysis of n = 44 patients who underwent AMIC® via arthrotomy and MMO vs. arthrotomy alone showed no significant differences in patient-reported outcome measures (PROMs, i.e. FAAM-ADL, and FAOS) at 6,12 and 24 months. Conclusions MMO are mostly used in the treatment of severe (≥ ICRS grade 3) OCL of the medial talar dome and in revision surgery. Functional and patient-reported outcome measures are not significantly affected by MMO compared to arthrotomy alone. Trial registration The German Cartilage Register (KnorpelRegister DGOU) was initially registered at the German Clinical Trials Register ( https://www.drks.de , register number DRKS00005617, Date of registration 03.01.2014) and was later expanded by the ankle module.

In patients with spinal cord injury (SCI), patient-reported outcomes (PROMs) and experience of care measures (PREMs) are extremely relevant for the prognosis. However, there is a paucity of research on these topics. We conducted a cross-sectional study to investigate the relationships between these patient outcomes and other demographic and clinical variables in adult SCI patients discharged from the intensive care unit of an Italian tertiary rehabilitation hospital. We administered the Consultation and Relational Empathy (CARE) for perceived relational empathy, the Spinal Cord Independence Measure III self-report (SCIM-SR) for functional autonomy, the Numeric Rating Scale (NRS) for pain, and the Connor–Davidson Resilience Scale (CD-RISC-10) for resilience. Study participants consisted of 148 adults with SCI; 82.4% were male, with a mean age of 49.9 years (SD = 16.6). The lesion was traumatic in 82.4% and complete in 74.3% of cases. The median length of hospital stays was 35 days (interquartile range—IQR = 23–60). Perceived relational empathy was positively associated with resilience (r = 0.229, p = 0.005) and negatively associated with the length of the stay and lesion completeness. Resilience had a weak negative association with pain (r = −0.173, p = 0.035) and was unrelated to other variables. Clinicians should consider the routine assessment of PREMs and PROMs in order to personalize post-discharge therapeutic plans and identify appropriate measures to ensure continuity of care. [ABSTRACT FROM AUTHOR]

Soft tissue facial injuries (STFI) constitute a huge portion of craniofacial trauma, but the risk of surgical site infection (SSI) and patient-reported outcomes (PROs) following surgical management of STFI are unknown. A PRISMA-compliant search was conducted from January 1990 until March 2023, and meta-analysis was performed using R. Pooled effects of the outcomes were estimated using the DerSimonian and Laird random-effects model or generalised linear mixed model, when feasible. Among the 8897 screened studies, 38 were included. Twelve studies reported PROMs (n = 985), whereas 28 studies reported SSI rates (n = 10,996) following operative treatment for STFI. The pooled SSI rate (n = 28) was 3.30 % (95 % CI 1.89 %–5.71 %). Surgical and non-surgical closure did not differ significantly in SSI rate. PROs focused on scar outcomes, cosmetic outcomes, quality of life and psychological impact. Subgroup analysis showed lower SSI risk in operative repair for general facial trauma compared to primary repair, and in general facial trauma compared to other aetiologies. The pooled patient scar assessment scale, score at 6–12 months post-intervention (5 studies, n = 217) was 16.16 (95 % CI 15.34–16.97). Limited evidence is available on the effect and superiority of surgical treatment in cosmetic outcomes, quality of life and psychological impact. Our findings emphasise the limited and unreliable evidence available on PROs following operative treatment for STFI. Future studies employing robust methodologies are needed to investigate optimal approaches for managing STFI. [ABSTRACT FROM AUTHOR]

The International Patient Organisation for Primary Immunodeficiencies (IPOPI) held its second Global Multi-Stakeholders’ Summit, an annual stimulating and forward-thinking meeting uniting experts to anticipate pivotal upcoming challenges and opportunities in the field of primary immunodeficiency (PID). The 2023 summit focused on three key identified discussion points: (i) How can immunoglobulin (Ig) therapy meet future personalized patient needs? (ii) Pandemic preparedness: what’s next for public health and potential challenges for the PID community? (iii) Diagnosing PIDs in 2030: what needs to happen to diagnose better and to diagnose more? Clinician-Scientists, patient representatives and other stakeholders explored avenues to improve Ig therapy through mechanistic insights and tailored Ig preparations/products according to patient-specific needs and local exposure to infectious agents, amongst others. Urgency for pandemic preparedness was discussed, as was the threat of shortage of antibiotics and increasing antimicrobial resistance, emphasizing the need for representation of PID patients and other vulnerable populations throughout crisis and care management. Discussion also covered the complexities of PID diagnosis, addressing issues such as global diagnostic disparities, the integration of patient-reported outcome measures, and the potential of artificial intelligence to increase PID diagnosis rates and to enhance diagnostic precision. These proceedings outline the outcomes and recommendations arising from the 2023 IPOPI Global Multi-Stakeholders’ Summit, offering valuable insights to inform future strategies in PID management and care. Integral to this initiative is its role in fostering collaborative efforts among stakeholders to prepare for the multiple challenges facing the global PID community. [ABSTRACT FROM AUTHOR]

Simple Summary: Breast cancer is one of the most diagnosed malignancies among women worldwide, affecting 18,000 women annually in the Netherlands. As life expectancy increases, monitoring quality of life (QoL) using Patient-Reported Outcome Measures (PROMs) becomes more important. The EQ-5D-5L and the EORTC QLQ-C30 are two widely used PROMs in the Netherlands. For utilizing PROMs in research and clinical care, internal responsiveness is key. Given the broad application of these PROMs in the Netherlands and the fact that internal responsiveness varies based on the disease, treatment regime, and geographical factors, this study assesses and compares the internal responsiveness of the EQ-5D-5L and the EORTC QLQ-C30 among Dutch breast cancer patients during the first year post-surgery. The results demonstrated that the EQ-5D-5L and the EORTC QLQ-C30 have small internal responsiveness (<0.5) at 6- and 12 months post-surgery. These findings provide crucial insights for interpreting outcomes from both PROMs in research and clinical practice. The EuroQoL 5-Dimension 5-Level questionnaire (EQ-5D-5L) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30) are commonly used Patient-Reported Outcome Measures (PROMs) for breast cancer. This study assesses and compares the internal responsiveness of the EQ-5D-5L and EORTC QLQ-C30 in Dutch breast cancer patients during the first year post-surgery. Women diagnosed with breast cancer who completed the EQ-5D-5L and EORTC QLQ-C30 pre-operatively (T0), 6 months (T6), and 12 months post-surgery (T12) were included. Mean differences of the EQ-5D-5L and EORTC QLQ-C30 between baseline and 6 months (delta 1) and between baseline and 12 months post-surgery (delta 2) were calculated and compared against the respective minimal clinically important differences (MCIDs) of 0.08 and 5. Internal responsiveness was assessed using effect sizes (ES) and standardized response means (SRM) for both deltas. In total, 333 breast cancer patients were included. Delta 1 and delta 2 for the EQ-5D-5L index and most scales of the EORTC QLQ-C30 were below the MCID. The internal responsiveness for both PROMs was small (ES and SRM < 0.5), with greater internal responsiveness for delta 1 compared to delta 2. The EQ-5D-5L index showed greater internal responsiveness than the EORTC QLQ-C30 Global Quality of Life scale and summary score. These findings are valuable for the interpretation of both PROMs in Dutch breast cancer research and clinical care. [ABSTRACT FROM AUTHOR]

Background: There has long been discussion regarding the impact of medial malleolar osteotomies (MMO) as an adjunctive treatment for osteochondral lesions of the talus (OCLT). MMO may improve the visibility and accessibility of the talus, but they also pose a risk of periprocedural morbidity. There is a lack of research about the prevalence and consequences of MMO in the surgical treatment of OCLT. Methods: This study retrospectively evaluated data from the German Cartilage Register (KnorpelRegister DGOU) from its implementation in 2015 to December 2020. The impact of MMO on patient-reported outcome measures (PROMs) was investigated. Wherever possible, subgroups were built and matched using a propensity score which matched a group undergoing OCLT without MMO. Matching included age, sex, weight, localization of the OCLT, the international cartilage repair society (ICRS) grading, surgical procedure and preoperative symptoms using the Foot and Ankle Ability Measure (FAAM) and the Activities of Daily Living Subscale (ADL). Results: The prevalence of MMO in the operative treatment of OCLT was 15.9%. Most of the osteotomies were performed in OCL of the medial talar dome (76.8%) and in more serious lesions with an ICRS grade of III (29.1%) and IV (61.4%). More than half of the osteotomies (55.6%) were performed during revision surgery. A matched pair analysis of n = 44 patients who underwent AMIC® via arthrotomy and MMO vs. arthrotomy alone showed no significant differences in patient-reported outcome measures (PROMs, i.e. FAAM-ADL, and FAOS) at 6,12 and 24 months. Conclusions: MMO are mostly used in the treatment of severe (≥ ICRS grade 3) OCL of the medial talar dome and in revision surgery. Functional and patient-reported outcome measures are not significantly affected by MMO compared to arthrotomy alone. Trial registration: The German Cartilage Register (KnorpelRegister DGOU) was initially registered at the German Clinical Trials Register (https://www.drks.de, register number DRKS00005617, Date of registration 03.01.2014) and was later expanded by the ankle module. [ABSTRACT FROM AUTHOR]

Patient‐reported outcomes (PROs) are closely related to the delivery of high‐quality care and services. Patient‐reported outcome measures (PROMs) are the tools used to measure the PROs. Despite the challenges and barriers associated with using PROs and PROMs, measuring PROs is valuable for a patient's health status and advancing evidence‐based medicine. Real‐world implementation of PROMs may especially open possibilities for healthcare systems under reform, such as Saudi Arabia. This paper highlights the concepts of PROs and PROMs. Moreover, it distinguishes between PROs and other concepts such as patient experience, quality of life, and patient satisfaction. It also explores the available literature in Saudi Arabia and the world regarding PROs and their role in improving healthcare systems. Last, this paper advocates for utilizing the national and comprehensive tools of PROMS in different levels and disciplines. Key points: Patient‐reported outcomes provide an opportunity to engage patients in their care, enhance shared decision making, and improve care effectively and safely.Integrating patient‐reported outcome measures (PROMs) in patient care has been associated with improving patient safety and patient experience and helping achieve more patient‐centered care.Related literature demonstrated some limitations that might hinder the effective implementation of PROMs, related to the integrity of data and lack of methodological standardization of PROMs data.Patient‐reported outcomes are poorly addressed within the Saudi literature, and the utilization of PROs is also underdeveloped and needs further consideration.There is an excellent opportunity for researching and implementing PROMs in the healthcare setting in Saudi Arabia, which is currently undergoing a major transformation. [ABSTRACT FROM AUTHOR]

Patients’ self-reporting is increasingly considered essential to measure quality-of-life and treatment-related side-effects. However, if multiple patient-reported instruments are used, redundancy may represent an overload for patients.Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) are a tool allowing direct patients’ reporting of side-effects.We tested psychometric properties of a selected list of PRO-CTCAE items, in a cohort of 303 breast cancer patients, using validated instruments for quality of life assessment as anchors.The analysis of convergent validity with HADS (Hospital Anxiety and Depression Scale) and EORTC BR-23 sub-scales, and the analysis of responsiveness with the PGIC (Patients Global Impression of Change) score supported that a selected list of PRO-CTCAE symptoms might represent a standardized, agile tool for both research and practice settings to reduce patient burden without missing relevant information on patient perceptions.Among patients using digital devices, those with a higher education levels required shorter time to fulfil questionnaires.In conclusion, a selected list of PRO-CTCAE items can be considered as a standardized, agile tool for capturing crucial domains of side-effects and quality of life in patients with breast cancer.The study is registered on clinicaltrials.gov (NCT04416672).

Aims: The primary objective of this registry-based study was to compare patient-reported outcomes of cementless and cemented medial unicompartmental knee arthroplasty (UKA) during the first postoperative year. The secondary objective was to assess one- and three-year implant survival of both fixation techniques. Methods: We analyzed 10,862 cementless and 7,917 cemented UKA cases enrolled in the Dutch Arthroplasty Registry, operated between 2017 and 2021. Pre- to postoperative change in outcomes at six and 12 months’ follow-up were compared using mixed model analyses. Kaplan-Meier and Cox regression models were applied to quantify differences in implant survival. Adjustments were made for patient-specific variables and annual hospital volume. Results: Change from baseline in the Oxford Knee Score (OKS) and activity-related pain was comparable between groups. Adjustment for covariates demonstrated a minimally greater decrease in rest-related pain in the cemented group (β = -0.09 (95% confidence interval (CI) -0.16 to -0.01)). Cementless fixation was associated with a higher probability of achieving an excellent OKS outcome (> 41 points) (adjusted odds ratio 1.2 (95% CI 1.1 to 1.3)). The likelihood of one-year implant survival was greater for cemented implants (adjusted hazard ratio (HR) 1.35 (95% CI 1.01 to 1.71)), with higher revision rates for periprosthetic fractures of cementless implants. During two to three years’ follow-up, the likelihood of implant survival was non-significantly greater for cementless UKA (adjusted HR 0.64 (95% CI 0.40 to 1.04)), primarily due to increased revision rates for tibial loosening of cemented implants. Conclusion: Cementless and cemented medial UKA led to comparable improvement in physical function and pain reduction during the initial postoperative year, albeit with a greater likelihood of achieving excellent OKS outcomes after cementless UKA. Anticipated differences in early physical function and pain should not be a decisive factor in the choice of fixation technique. However, surgeons should consider the differences in short- and long-term implant survival when deciding which implant to use. Cite this article: Bone Jt Open 2024;5(5):401–410.

Background: Unhelpful illness perceptions can be changed by means of interventions and can lead to improved outcomes. However, little is known about illness perceptions in patients with chronic kidney disease (CKD) prior to kidney failure, and no tools exist in nephrology care to identify and support patients with unhelpful illness perceptions. Therefore, this study aims to: (1) identify meaningful and modifiable illness perceptions in patients with CKD prior to kidney failure; and (2) explore needs and requirements for identifying and supporting patients with unhelpful illness perceptions in nephrology care from patients' and healthcare professionals' perspectives. Methods: Individual semi-structured interviews were conducted with purposive heterogeneous samples of Dutch patients with CKD (n = 17) and professionals (n = 10). Transcripts were analysed using a hybrid inductive and deductive approach: identified themes from the thematic analysis were hereafter organized according to Common-Sense Model of Self-Regulation principles. Results: Illness perceptions considered most meaningful are related to the seriousness (illness identity, consequences, emotional response and illness concern) and manageability (illness coherence, personal control and treatment control) of CKD. Over time, patients developed more unhelpful seriousness-related illness perceptions and more helpful manageability-related illness perceptions, caused by: CKD diagnosis, disease progression, healthcare support and approaching kidney replacement therapy. Implementing tools to identify and discuss patients' illness perceptions was considered important, after which support for patients with unhelpful illness perceptions should be offered. Special attention should be paid towards structurally embedding psychosocial educational support for patients and caregivers to deal with CKD-related symptoms, consequences, emotions and concerns about the future. Conclusions: Several meaningful and modifiable illness perceptions do not change for the better by means of nephrology care. This underlines the need to identify and openly discuss illness perceptions and to support patients with unhelpful illness perceptions. Future studies should investigate whether implementing illness perception-based tools will indeed improve outcomes in CKD. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to explore ovarian cancer patients’ preferences regarding follow-up care and, in particular, the use of patient-reported outcome measures (PROMs) as an approach to personalise follow-up care. Methods: Between May and June 2021, semi-structured interviews were conducted with ovarian cancer patients, who had finished their primary treatment at least 6 months prior and were receiving follow-up care at our centre. Interviews were transcribed verbatim and analysed using an inductive thematic approach. A thematic flow chart was created describing interacting themes. Results: Seventeen patients were interviewed, of which 11 were familiar with PROMs. Two key themes emerged from the data: the need for reassurance and the wish for personalised care. A follow-up scheme using PROMs was identified as a separate theme with the potential to personalise care. Several barriers and facilitators of PROMs were mentioned. Conclusions: Ovarian cancer patients have a desire for personalised follow-up care and seek reassurance. PROMs may be able to support both of these needs. Future research is needed to determine the most effective, patient-centred way to implement them. Implications for cancer survivors: By understanding what patients’ preferences are regarding follow-up care, more initiatives can be set up to personalise follow-up care, through which patient anxiety and dissatisfaction can be reduced. [ABSTRACT FROM AUTHOR]

Purpose: This study examines providers’ and clinic staff’s perspectives on patient-reported outcomes (PROs) implementation at an academic medical center. Methods: An anonymous and voluntary survey was administered to Henry Ford Cancer providers and clinic staff 18 months after PROs program implementation in September 2020, to obtain their feedback on perceived barriers, impact on workflows, and PROs administration frequency in routine cancer care. Results: A total of 180 providers and 40 clinic staff were invited to complete the survey; 31% and 63% completed the survey, respectively. Approximately 68% of providers reported that electronically integrated PROs scores were either beneficial or somewhat beneficial to their patients, while only 28% of the clinic staff reported that PROs were beneficial or somewhat beneficial to patients. According to the clinic staff, the most common barriers to PROs completion included lack of patients’ awareness of the utility of the program with respect to their care, patients’ health status at check-in, and PROs being offered too frequently. Conclusion: There is favorable acceptance of the PROs program by providers, but clinic staff found it less favorable. Interventions to address barriers and improve program engagement are needed to ensure broad adoption of PROs in oncology practice. [ABSTRACT FROM AUTHOR]

Aims: The primary aim of this study was to report the radiological outcomes of patients with a dorsally displaced distal radius fracture who were randomized to a moulded cast or surgical fixation with wires following manipulation and closed reduction of their fracture. The secondary aim was to correlate radiological outcomes with patient-reported outcome measures (PROMs) in the year following injury. Methods: Participants were recruited as part of DRAFFT2, a UK multicentre clinical trial. Participants were aged 16 years or over with a dorsally displaced distal radius fracture, and were eligible for the trial if they needed a manipulation of their fracture, as recommended by their treating surgeon. Participants were randomly allocated on a 1:1 ratio to moulded cast or Kirschner wires after manipulation of the fracture in the operating theatre. Standard posteroanterior and lateral radiographs were performed in the radiology department of participating centres at the time of the patient’s initial assessment in the emergency department and six weeks postoperatively. Intraoperative fluoroscopic images taken at the time of fracture reduction were also assessed. Results: Patients treated with surgical fixation with wires had less dorsal angulation of the radius versus those treated in a moulded cast at six weeks after manipulation of the fracture; the mean difference of -4.13° was statistically significant (95% confidence interval 5.82 to -2.45). There was no evidence of a difference in radial shortening. However, there was no correlation between these radiological measurements and PROMs at any timepoint in the 12 months post-injury. Conclusion: For patients with a dorsally displaced distal radius fracture treated with a closed manipulation, surgical fixation with wires leads to less dorsal angulation on radiographs at six weeks compared with patients treated in a moulded plaster cast alone. However, the difference in dorsal angulation was small and did not correlate with patient-reported pain and function. Cite this article: Bone Jt Open 2024;5(2):132–138.

Aims: A novel enhanced cement fixation (EF) tibial implant with deeper cement pockets and a more roughened bonding surface was released to market for an existing total knee arthroplasty (TKA) system.This randomized controlled trial assessed fixation of the both the EF (ATTUNE S+) and standard (Std; ATTUNE S) using radiostereometric analysis. Methods: Overall, 50 subjects were randomized (21 EF-TKA and 23 Std-TKA in the final analysis), and had follow-up visits at six weeks, and six, 12, and 24 months to assess migration of the tibial component. Low viscosity bone cement with tobramycin was used in a standardized fashion for all subjects. Patient-reported outcome measure data was captured at preoperative and all postoperative visits. Results: The patient cohort mean age was 66 years (SD seven years), 59% were female, and the mean BMI was 32 kg/m2 (SD 6 kg/m2). Mean two-year subsidence of the EF-TKA was 0.056 mm (95% confidence interval (CI) 0.025 to 0.086) versus 0.006 mm (95% CI -0.029 to 0.040) for the Std-TKA, and the two-year maximum total point motion (MTPM) was 0.285 mm (95% upper confidence limit (UCL) ≤ 0.363) versus 0.346 mm (95% UCL ≤ 0.432), respectively, for a mean difference of -0.061 mm (95% CI -0.196 to 0.074). Inducible displacement also did not differ between groups. The MTPMs between 12 and 24 months for each group was below the published threshold of 0.2 mm for predicting early aseptic loosening (p < 0.001 and p = 0.001, respectively). Conclusion: Both the enhanced fixation and the standard tibial implant design showed fixation with a predicted low risk of long-term aseptic loosening. Cite this article: Bone Jt Open 2024;5(1):20–27.

Aims: We assessed the long-term outcomes of a large cohort of patients who have undergone a periacetabular osteotomy (PAO), and sought to validate a patient satisfaction questionnaire for use in a PAO cohort. Methods: All patients who had undergone a PAO from July 1998 to February 2013 were surveyed, with several patient-reported outcome measures (PROMs) and radiological measurements of preoperative acetabular dysplasia and postoperative correction also recorded. Patients were asked to rate their level of satisfaction with their operation in achieving pain relief, restoration of activities of daily living, ability to perform recreational activity, and their overall level of satisfaction with the procedure. Results: A total of 143 PAOs were performed between 1998 and 2013. Of those, 90 postoperative surveys were returned. Only 65 patients (73 hips) had both pre- and postoperative radiographs available for measurement. The mean time to follow-up was 15 years (6.5 to 20). Most patients were female (91%), with a mean age of 26.4 years (14.9 to 48.3) at the time of their surgery. A statistically significant improvement in radiological correction was detected in all hips (p < 0.001). A total of 67 patients (92.3%) remained either very satisfied or satisfied with their PAO. The internal consistency of the patient satisfaction questionnaire, measured using Cronbach’s α, ranged from 0.89 to 0.94 indicating ‘good’ to ‘excellent’ reliability. Conclusion: Outcomes of importance to patients undergoing a PAO include several key domains: pain relief, improve activities of daily living, and improve recreational ability. Our study demonstrates high rates of long-term patient satisfaction in all domains, and found the patient satisfaction questionnaire to be a valid and reliable instrument for use in this cohort. Cite this article: Bone Jt Open 2023;4(12):964–969.

Aims: With up to 40% of patients having patellofemoral joint osteoarthritis (PFJ OA), the two arthroplasty options are to replace solely the patellofemoral joint via patellofemoral arthroplasty (PFA), or the entire knee via total knee arthroplasty (TKA). The aim of this study was to assess postoperative success of second-generation PFAs compared to TKAs for patients treated for PFJ OA using patient-reported outcome measures (PROMs) and domains deemed important by patients following a patient and public involvement meeting. Methods: MEDLINE, EMBASE via OVID, CINAHL, and EBSCO were searched from inception to January 2022. Any study addressing surgical treatment of primary patellofemoral joint OA using second generation PFA and TKA in patients aged above 18 years with follow-up data of 30 days were included. Studies relating to OA secondary to trauma were excluded. ROB-2 and ROBINS-I bias tools were used. Results: A total of nine studies were included, made up of four randomized controlled trials (domain 1) and five cohort studies (domain 2). PROMs and knee function specific scores developed for reporting TKA were unable to detect any difference between PFA and TKA. There was no significant difference in complications between PFA and TKA. PFAs were found to have a better postoperative range of motion. Conclusion: TKA and PFA are both viable options for patients with primary PFJ OA. Over time, we have seen an emphasis on patient satisfaction and better quality of life. Recommending sacrificing healthy medial and lateral compartments to treat patellofemoral joint arthritis should be given further thought. Cite this article: Bone Jt Open 2023;4(12):948–956.

Abstract Background We recently developed a novel, preference-based method (Better-Worse, BW) for measuring health status, expressed as a single metric value. We have since expanded it by developing the Drop-Down (DD) method. This article presents a head-to-head comparison of these two methods. We explored user feasibility, interpretability and statistics of the estimated coefficients, and distribution of the computed health-state values. Methods We conducted a cross-sectional online survey among patients with various diseases in the USA. The BW and DD methods were applied in the two arms of the study, albeit in reverse order. In both arms, patients first performed a descriptive task (Task 1) to rate their own health status according to the 12 items (each with 4 levels) in the CS-Base health-outcome instrument. They then performed Task 2, in which they expressed preferences for health states by the two methods. We then estimated coefficients for all levels of each item using logistic regression and used these to compute values for health states. Results Our total sample comprised 1,972 patients. Completion time was

Background: The Phase 1/2 Treat_CCM randomized controlled trial for people with familial cerebral cavernous malformations (FCCMs) confirmed the safety of propranolol and suggested beneficial effects on intracerebral hemorrhage or new focal neurological deficits, but the effects on patient-reported outcome measures have not been reported. Methods: Participants completed self-reported questionnaires at baseline, 1 and 2 years. Depression was assessed with the Beck Depression Inventory-II (BDI-2); Anxiety with the State-Trait Anxiety Inventory X1 and X2 (STAI X-1 and STAI X-2); and Quality of Life with the Short Form 36 (SF-36), split into the physical and mental component scales (PCS and MCS). Differences between treatment groups and the general population were assessed. Change over time by treatment was assessed by means of mixed models. Results: In total, 71 participants (48 propranolol and 23 standard care) were enrolled, of whom 61 (73%) completed questionnaires at baseline and 2-year FU. At baseline, no differences between treatment groups for any of the questionnaires were present. Twenty (31.7%) patients were considered depressed at baseline, while this proportion was lower in the propranolol group after 2 years (28.6% vs. 55.5%, p = 0.047). The STAI X-1 and X-2 scores were stable over time. PCS was lower in FCCM patients as compared with the general Italian population, while the MCS was similar to the general population. No effect of propranolol was found for both PCS and MCS. Conclusion: Depression is common among patients with FCCM. Patients randomized to propranolol had a lower proportion of participants with depression after 2 years. [ABSTRACT FROM AUTHOR]

There is a growing awareness of the significance of using minimum clinically important differences (MCIDs) in stroke research. An MCID is the smallest change in an outcome measure that is considered clinically meaningful. This review is the first to provide a comprehensive summary of various scales and patient-reported outcome measures (PROMs) used in stroke research and their MCID values reported in the literature, including a concise overview of the concept of and methods for determining MCIDs in stroke research. Despite the controversies and limitations surrounding the estimation of MCIDs, their importance in modern clinical trials cannot be overstated. Anchor-based and distribution-based methods are recommended for estimating MCIDs, with patient self-evaluation being a crucial component in capturing the patient's perspective on their health. A combination of methods can provide a more comprehensive understanding of the clinical relevance of treatment effects, and incorporating the patient's perspective can enhance the care of stroke patients. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcome measures (PROMs) are increasingly being used as an assessment and monitoring tool in clinical practice. However, patient adherence to PROMs completions are typically not well documented or explained in published studies and reports. Through a collaboration between the International Society for Quality-of-Life Research (ISOQOL) Patient Engagement and QOL in Clinical Practice Special Interest Groups (SIGs) case studies were collated as a platform to explore how adherence can be evaluated and understood. Case studies were drawn from across a range of clinically and methodologically diverse PROMs activities. Results: The case studies identified that the influences on PROMs adherence vary. Key drivers include PROMs administeration methods within a service and wider system, patient capacity to engage and clinician engagement with PROMs information. It was identified that it is important to evaluate PROMs integration and adherence from multiple perspectives. Conclusion: PROM completion rates are an important indicator of patient adherence. Future research prioritizing an understanding of PROMs completion rates by patients is needed. [ABSTRACT FROM AUTHOR]

Background: We recently developed a novel, preference-based method (Better-Worse, BW) for measuring health status, expressed as a single metric value. We have since expanded it by developing the Drop-Down (DD) method. This article presents a head-to-head comparison of these two methods. We explored user feasibility, interpretability and statistics of the estimated coefficients, and distribution of the computed health-state values. Methods: We conducted a cross-sectional online survey among patients with various diseases in the USA. The BW and DD methods were applied in the two arms of the study, albeit in reverse order. In both arms, patients first performed a descriptive task (Task 1) to rate their own health status according to the 12 items (each with 4 levels) in the CS-Base health-outcome instrument. They then performed Task 2, in which they expressed preferences for health states by the two methods. We then estimated coefficients for all levels of each item using logistic regression and used these to compute values for health states. Results: Our total sample comprised 1,972 patients. Completion time was < 2 min for both methods. Both methods were scored as easy to perform. All DD coefficients were highly significant from the reference level (P < 0.001). For BW, however, only the second-level coefficient of "Cognition" was significantly different (P = 0.026). All DD coefficients were more precise with narrower confidence intervals than those of the BW method. Conclusions: Both the BW and DD are novel methods that are easy to apply. The DD method outperformed the BW method in terms of the precision of produced coefficients. Due to its task, it is free from a specific distorting factor that was observed for the BW method. [ABSTRACT FROM AUTHOR]

Ruxolitinib (RUX) is a Janus kinase 1/2 inhibitor (JAKi) approved in the EU for treating disease‑related splenomegaly or symptoms in adults patients with myelofibrosis (MF). This is an interim analysis of JAKoMo, a prospective, non‑interventional, phase IV study in MF. Between 2012–2019 (cutoff March 2021), 928 patients (JAKi-naïve and -pretreated) enrolled from 122 German centers. This analysis focuses on JAKi-naïve patients. RUX was administered according to the Summary of Product Characteristics. Compared to the COMFORT-I, -II, and JUMP trials, patients in JAKoMo were older (median 73 years), had poorer Eastern Cooperative Oncology Group (ECOG) performance statuses (16.5% had ECOG ≥ 2), and were more transfusion dependent (48.5%). JAKoMo represents the more challenging patients with MF encountered outside of interventional studies. However, patients with low-risk International Prognostic Scoring System (IPSS) scores or without palpable splenomegaly were also included. Following RUX treatment, 82.5% of patients experienced rapid (≤ 1 month), significant decreases in palpable spleen size, which remained durable for 24 months (60% patients). Symptom assessment scores improved significantly in Month 1 (median –5.2) up to Month 12 (–6.2). Common adverse events (AEs) were anemia (31.2%) and thrombocytopenia (28.6%). At cutoff, 54.3% of patients had terminated the study due to, death, AEs, or deterioration of health. No new safety signals were observed. Interim analysis of the JAKoMo study confirms RUX safety and efficacy in a representative cohort of real-world, elderly, JAKi-naïve patients with MF. Risk scores were used in less than half of the patients to initiate RUX treatment. Trial registration: NCT05044026; September 14, 2021. [ABSTRACT FROM AUTHOR]

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. 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. 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. 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). [ABSTRACT FROM AUTHOR]

BackgroundStroke incidence among young adults of working age (under 65 years of age) has significantly increased in the past decade, with major individual, social, and economic implications. There is a paucity of research exploring the needs of this patient population. This study assessed: (1) young adult stroke patients' physical, psychological, and occupational functioning and health-related quality of life (HRQoL); and (2) post-stroke care preferences using patient-reported outcome measures (PROMs), with attention to gender differences.MethodsA cross-sectional pilot study was conducted. Sociodemographic and clinical characteristics were collected through chart review and data on occupational function, physical, psychological, and social wellbeing >90 days post-stroke through a self-reported survey. Descriptive statistics, gender-based, and regression analyses were conducted.ResultsThe sample included 85 participants. Participants reported impairments in both, occupational functioning, with 58.7% not returned to work (RTW), and HRQoL, specifically with social activities (37%), anxiety (34%), and cognitive function (34%). Women had significantly (p < 0.05) worse physical symptoms (sleep disturbance and fatigue), emotional health (depression, stigma, emotional dyscontrol) scores, and sense of self-identify post-stroke. Over 70% of participants preferred in-person post-stroke care led by health care providers and felt they would have benefited from receiving information on physical health (71.4%), emotional and psychological health (56.0%), RTW (38.1%), and self-identity (26.2%) post-stroke. Women preferred cognitive behavioral therapy (p = 0.018) and mindfulness-based stress reduction therapy (p = 0.016), while men preferred pharmacotherapy (p = 0.02) for psychological symptoms.ConclusionThis is the first study to report impaired HRQoL, psychological and occupational functioning using PROMs, with significant gender differences and preferences for post-stroke care delivery among young adult stroke patients at >90 days after stroke. The findings highlight the importance of needs, gender, and age-specific post-stroke education and interventions.

Abstract Background The self-perceived health status of patients undergoing total hip and knee arthroplasty (THA and TKA) might differ post-operatively due to gender, age, or comorbidities. Patient-reported outcome measures (PROMs) such as the EQ-5D-5L measure the self-perceived health status. This study investigates whether the index score of the EQ-5D-5L is a valid tool for interpreting gender differences in outcomes for patients undergoing THA and TKA. Methods Routine and PROM-data of elective primary THA or TKA patients in two German hospitals between 2016 and 2018 were analyzed. Univariate analysis with Pearson’s chi-square was conducted to identify control variables for gender. To quantify the association between gender and the EQ-5D-5L dimensions, a cumulative odds ordinal logistic regression with proportional odds was conducted. Results Two thousand three hundred sixty-eight​​ THA patients (m = 978; f = 1390) and 1629 TKA patients (m = 715; f = 914) were considered. The regression analysis of the individual EQ-5D-5L dimensions showed that female gender was significantly associated with better self-care (THA and TKA) and better post-operative mobility (THA). In contrast, male gender was significantly associated with less pain/discomfort (TKA) and less anxiety/depression (THA) pre-surgery and 3-months post-surgery. Conclusion Our results confirmed that the self-perceived health status improved after surgery. However, due to the different associations of gender to the individual dimensions of the EQ-5D-5L, the weighted index score clouds the comparability between patients with different gender undergoing THA or TKA. Therefore, we argue to use the individual five dimensions for health status analysis, to reveal relevant additional information.

Aims: To evaluate mid-to long-term patient-reported outcome measures (PROMs) of endoprosthetic reconstruction after resection of malignant tumours arising around the knee, and to investigate the risk factors for unfavourable PROMs. Methods: The medical records of 75 patients who underwent surgery between 2000 and 2020 were retrospectively reviewed, and 44 patients who were alive and available for follow-up (at a mean of 9.7 years postoperatively) were included in the study. Leg length discrepancy was measured on whole-leg radiographs, and functional assessment was performed with PROMs (Toronto Extremity Salvage Score (TESS) and Comprehensive Outcome Measure for Musculoskeletal Oncology Lower Extremity (COMMON-LE)) with two different aspects. The thresholds for unfavourable PROMs were determined using anchor questions regarding satisfaction, and the risk factors for unfavourable PROMs were investigated. Results: The thresholds for favourable TESS and COMMON were 64.8 and 70.4 points, respectively. Multivariate analysis showed that age at surgery (p = 0.004) and postoperative leg length discrepancy (p = 0.043) were significant risk factors for unfavourable TESS results, while age at surgery (p < 0.001) was a significant risk factor for unfavourable COMMON-LE results. Following receiver operating characteristic analysis, the threshold for both TESS and COMMON-LE was 29 years of age at surgery. Additionally, a leg length discrepancy of 8.2 mm was the threshold for unfavourable TESS. Conclusion: Patients aged > 29 years at the time of surgery require appropriate preoperative counselling and adequate postoperative physical and socioemotional support. Reconstruction equivalent to the length of the resected bone can reduce the risk of functional disabilities in daily living. Cite this article: Bone Jt Open 2023;4(12):906–913.

Abstract Background Previous studies have assessed different aspects concerning the applications of i-PRF in the oral cavity. However, nothing is known regarding patients’ perceptions of the injection of autologous platelet-rich fibrin (i-PRF). Objectives To investigate patients’ perceptions after injecting platelet-rich fibrin (i-PRF) in the course of retracting upper canines. Methods Twenty-one patients, whose treatments required extractions of both upper first premolars, were recruited. Extraction side was randomly allocated to the intervention or control sides. After the alignment phase, i-PRF was injected twice with a one-month interval on the buccal and palatal aspects of the extraction sites (intervention side). Patients’ perceptions were evaluated with two questionnaires: the first was used to assess the level of pain, discomfort, swelling, eating and swallowing difficulties as well as jaw movement restriction after 1 h (T1), 2 h (T2), 6 h (T3), 24 h (T4) and 48 h (T5) of the second injection; the second questionnaire was used to assess the acceptance of the i-PRF injection and overall satisfaction with this technique at the end of canine retraction phase. Visual Analogue Scale (VAS) was adopted for this purpose. Wilcoxon Signed Rank Test was used to compare between both sides at all time points while Friedman’s Test was the selected test for detecting variables’ changes over time. Post-hoc Wilcoxon Matched-Pairs Signed-Rank Tests were applied when any of the results were significant. As to the multiplicity of tests, Bonferroni Correction was implemented. Results Pain and swelling levels were significantly higher on the experimental compared to the control sides at T1, T2, and T3 (P

Aims: To map the Oxford Knee Score (OKS) and High Activity Arthroplasty Score (HAAS) items to a common scale, and to investigate the psychometric properties of this new scale for the measurement of knee health. Methods: Patient-reported outcome measure (PROM) data measuring knee health were obtained from the NHS PROMs dataset and Total or Partial Knee Arthroplasty Trial (TOPKAT). Assumptions for common scale modelling were tested. A graded response model (fitted to OKS item responses in the NHS PROMs dataset) was used as an anchor to calibrate paired HAAS items from the TOPKAT dataset. Information curves for the combined OKS-HAAS model were plotted. Bland-Altman analysis was used to compare common scale scores derived from OKS and HAAS items. A conversion table was developed to map between HAAS, OKS, and the common scale. Results: We included 3,329 response sets from 528 patients undergoing knee arthroplasty. These generally met the assumptions of unidimensionality, monotonicity, local independence, and measurement invariance. The HAAS items provided more information than OKS items at high levels of knee health. Combining both instruments resulted in higher test-level information than either instrument alone. The mean error between common scale scores derived from the OKS and HAAS was 0.29 logits. Conclusion: The common scale allowed more precise measurement of knee health than use of either the OKS or HAAS individually. These techniques for mapping PROM instruments may be useful for the standardization of outcome reporting, and pooling results across studies that use either PROM in individual-patient meta-analysis. Cite this article: Bone Joint Res 2023;12(10):624–635.

Aims: This prospective study reports longitudinal, within-patient, patient-reported outcome measures (PROMs) over a 15-year period following cemented single radius total knee arthroplasty (TKA). Secondary aims included reporting PROMs trajectory, 15-year implant survival, and patient attrition from follow-up. Methods: From 2006 to 2007, 462 consecutive cemented cruciate-retaining Triathlon TKAs were implanted in 426 patients (mean age 69 years (21 to 89); 290 (62.7%) female). PROMs (12-item Short Form Survey (SF-12), Oxford Knee Score (OKS), and satisfaction) were assessed preoperatively and at one, five, ten, and 15 years. Kaplan-Meier survival and univariate analysis were performed. Results: At 15 years, 28 patients were lost to follow-up (6.1%) and 221 patients (51.9%) had died, with the mean age of the remaining cohort reducing by four years. PROMs response rates among surviving patients were: one-year 63%; five-year 72%; ten-year 94%; and 15-year 59%. OKS and SF-12 scores changed significantly over 15 years (p < 0.001). The mean improvement in OKS was 18.8 (95% confidence (CI) 16.7 to 19.0) at one year. OKS peaked at five years (median 43 years) declining thereafter (p < 0.001), though at 15 years it remained 17.5 better than preoperatively. Age and sex did not alter this trajectory. A quarter of patients experienced a clinically significant decline (≥ 7) in OKS from five to ten years and from ten to 15 years. The SF-12 physical component score displayed a similar trajectory, peaking at one year (p < 0.001). Patient satisfaction was 88% at one, five, and ten years, and 94% at 15 years. In all, 15-year Kaplan-Meier survival was 97.6% (95% CI 96.0% to 99.2%) for any revision, and 98.9% (95% CI 97.9% to 99.9%) for aseptic revision. Conclusion: Improvements in PROMs were significant and maintained following single radius TKA, with OKS peaking at five years, and generic physical health peaking at one year. Patient satisfaction remained high at 15 years, at which point 2.4% had been revised. Cite this article: Bone Jt Open 2023;4(10):808–816.

Aims: A substantial fraction of patients undergoing knee arthroplasty (KA) or hip arthroplasty (HA) do not achieve an improvement as high as the minimal clinically important difference (MCID), i.e. do not achieve a meaningful improvement. Using three patient-reported outcome measures (PROMs), our aim was: 1) to assess machine learning (ML), the simple pre-surgery PROM score, and logistic-regression (LR)-derived performance in their prediction of whether patients undergoing HA or KA achieve an improvement as high or higher than a calculated MCID; and 2) to test whether ML is able to outperform LR or pre-surgery PROM scores in predictive performance. Methods: MCIDs were derived using the change difference method in a sample of 1,843 HA and 1,546 KA patients. An artificial neural network, a gradient boosting machine, least absolute shrinkage and selection operator (LASSO) regression, ridge regression, elastic net, random forest, LR, and pre-surgery PROM scores were applied to predict MCID for the following PROMs: EuroQol five-dimension, five-level questionnaire (EQ-5D-5L), EQ visual analogue scale (EQ-VAS), Hip disability and Osteoarthritis Outcome Score-Physical Function Short-form (HOOS-PS), and Knee injury and Osteoarthritis Outcome Score-Physical Function Short-form (KOOS-PS). Results: Predictive performance of the best models per outcome ranged from 0.71 for HOOS-PS to 0.84 for EQ-VAS (HA sample). ML statistically significantly outperformed LR and pre-surgery PROM scores in two out of six cases. Conclusion: MCIDs can be predicted with reasonable performance. ML was able to outperform traditional methods, although only in a minority of cases. Cite this article: Bone Joint Res 2023;12(9):512–521.

In patients with spinal cord injury (SCI), patient-reported outcomes (PROMs) and experience of care measures (PREMs) are extremely relevant for the prognosis. However, there is a paucity of research on these topics. We conducted a cross-sectional study to investigate the relationships between these patient outcomes and other demographic and clinical variables in adult SCI patients discharged from the intensive care unit of an Italian tertiary rehabilitation hospital. We administered the Consultation and Relational Empathy (CARE) for perceived relational empathy, the Spinal Cord Independence Measure III self-report (SCIM-SR) for functional autonomy, the Numeric Rating Scale (NRS) for pain, and the Connor–Davidson Resilience Scale (CD-RISC-10) for resilience. Study participants consisted of 148 adults with SCI; 82.4% were male, with a mean age of 49.9 years (SD = 16.6). The lesion was traumatic in 82.4% and complete in 74.3% of cases. The median length of hospital stays was 35 days (interquartile range—IQR = 23–60). Perceived relational empathy was positively associated with resilience (r = 0.229, p = 0.005) and negatively associated with the length of the stay and lesion completeness. Resilience had a weak negative association with pain (r = −0.173, p = 0.035) and was unrelated to other variables. Clinicians should consider the routine assessment of PREMs and PROMs in order to personalize post-discharge therapeutic plans and identify appropriate measures to ensure continuity of care.

Abstract Background Implementing Patient-reported Outcome Measures (PROMs) and Patient-reported Experience Measures (PREMs) is an effective way to deliver patient- and family-centered care (PFCC). Although Alberta Health Services (AHS) is Canada's largest and fully integrated health system, PROMs and PREMs are yet to be routinely integrated into the pediatric healthcare system. This study addresses this gap by investigating the current uptake, barriers, and enablers for integrating PROMs and PREMs in Alberta's pediatric healthcare system. Methods Pediatric clinicians and academic researchers with experience using PROMs and PREMs were invited to complete a quantitative survey. Additionally, key stakeholders were qualitatively interviewed to understand current challenges in implementing pediatric PROMs and PREMs within AHS. Quantitative data gathered from 22 participants were descriptively analyzed, and qualitative data from 14 participants were thematically analyzed. Results Participants identified 33 PROMs and 6 PREMs showing diversity in the types of pediatric PROMs and PREMs currently being used in Alberta and their mode of administration. The qualitatively identified challenges were associated with patients, family caregivers, and clinicians. The absence of system-level support, such as integration within electronic medical records, is considered a significant system-level challenge. Conclusions The significant variation in the types of PROMs and PREMs used, the rationale for their use, and their mode of administration demonstrate the diverse and sporadic use of these measures in Alberta. These findings highlight the need for province-wide uniform implementation of pediatric PROMs and PREMs in Alberta. Our results could benefit healthcare organizations in developing evidence-based PROM and PREM implementation strategies in pediatrics.

BackgroundThe Phase 1/2 Treat_CCM randomized controlled trial for people with familial cerebral cavernous malformations (FCCMs) confirmed the safety of propranolol and suggested beneficial effects on intracerebral hemorrhage or new focal neurological deficits, but the effects on patient-reported outcome measures have not been reported.MethodsParticipants completed self-reported questionnaires at baseline, 1 and 2 years. Depression was assessed with the Beck Depression Inventory-II (BDI-2); Anxiety with the State–Trait Anxiety Inventory X1 and X2 (STAI X-1 and STAI X-2); and Quality of Life with the Short Form 36 (SF-36), split into the physical and mental component scales (PCS and MCS). Differences between treatment groups and the general population were assessed. Change over time by treatment was assessed by means of mixed models.ResultsIn total, 71 participants (48 propranolol and 23 standard care) were enrolled, of whom 61 (73%) completed questionnaires at baseline and 2-year FU. At baseline, no differences between treatment groups for any of the questionnaires were present. Twenty (31.7%) patients were considered depressed at baseline, while this proportion was lower in the propranolol group after 2 years (28.6% vs. 55.5%, p = 0.047). The STAI X-1 and X-2 scores were stable over time. PCS was lower in FCCM patients as compared with the general Italian population, while the MCS was similar to the general population. No effect of propranolol was found for both PCS and MCS.ConclusionDepression is common among patients with FCCM. Patients randomized to propranolol had a lower proportion of participants with depression after 2 years.Clinical trial registration: https://clinicaltrials.gov/, identifier (NCT03589014).

Activity trackers and wearables allow accurate determination of physical activity, basic vital parameters, and tracking of complex medical conditions. This review attempts to provide a roadmap for the development of these applications, outlining the basic tools available, how they can be combined, and what currently exists in the marketplace for spine patients.Various types of sensors currently exist to measure distinct aspects of user movement. These include the accelerometer, gyroscope, magnetometer, barometer, global positioning system (GPS), Bluetooth and Wi-Fi, and microphone. Integration of data from these sensors allows detailed tracking of location and vectors of motion, resulting in accurate mobility assessments. These assessments can have great value for a variety of healthcare specialties, but perhaps none more so than spine surgery. Patient-reported outcomes (PROMs) are subject to bias and are difficult to track frequently - a problem that is ripe for disruption with the continued development of mobility technology.Currently, multiple mobile applications exist as an extension of clinical care. These include Manage My Surgery (MMS), SOVINITY-e-Healthcare Services, eHealth System, Beiwe Smartphone Application, QS Access, 6WT, and the TUG app. These applications utilize sensor data to assess patient activity at baseline and postoperatively. The results are evaluated in conjunction with PROMs. However, these applications have not yet exploited the full potential of available sensors.There is a need to develop smartphone applications that can accurately track the functional status and activity of spine patients, allowing a more quantitative assessment of outcomes, in contrast to legacy PROMs.