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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]

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]

The general objectives of spine surgery are to alleviate pain, restore neurologic function, and prevent or treat spinal deformities or instability. The accumulating expanse of outcome measures has allowed us to more objectively quantify these variables and, therefore, gauge the success of treatments, ultimately improving the quality of the delivered health care. It has become increasingly evident that spinal conditions and their accompanying interventions affect all aspects of a patient's life, including their physical, mental, emotional, and social well-being. This underscores the challenge of creating clinically relevant and accurate outcome measures in spine care, and the reason why there is a growing recognition of the importance of subjective measures such as patient-reported outcome measures, that consider a patients' health-related quality of life. Subjective measures provide valuable insights into patient experiences and perceptions of treatment outcomes, whereas objective measures provide a reproducible glimpse into key radiographic and clinical parameters that are associated with a successful outcome. In this narrative review, we provide a detailed analysis of the most common subjective and objective outcome measures employed in spine surgery, with a special focus on their current role as well as the possible future of outcome reporting. [ABSTRACT FROM AUTHOR]

Patient-reported outcome measures (PROMs) quantify patient perspectives to measure outcomes that matter to patients. The aim of this study was to assess the reporting of appropriateness and quality of PROM selection in plastic surgery randomized controlled trials (RCTs). MEDLINE, Embase, and CENTRAL were searched from January 1, 2000, to June 5, 2022, to identify published RCTs within the plastic surgery literature. Included studies were categorized as follows: 1) a clearly defined patient-reported primary outcome; 2) a primary outcome could be inferred; or 3) no clear or implied primary outcome. The Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) database was consulted to assess the available literature on the PROMs. There were 130 plastic surgery RCTs identified. Of the 43 studies with a clear or inferred primary outcome, the percentage of studies that commented with supporting references on the PROM's appropriateness for the population, disease/condition, and outcome were 20.9% (n = 9/43), 18.6% (n = 8/43), and 27.9% (n = 12/43), respectively. The percentage of studies that commented on the PROM's validity, reliability, and responsiveness with supporting references were 34.9% (n = 15/43), 14.0% (n = 6/43), and 11.7% (n = 5/43), respectively. There were 21 unique PROMs identified; 28.6% (n = 6/21) were available in the COSMIN database. The majority of plastic surgery RCTs assessing patient-reported primary outcomes lack transparency surrounding PROM selection and quality. We recommend investigators conducting plastic surgery clinical research report explicitly why they used a particular PROM and support its appropriateness and psychometric properties with supporting references. Finally, they should familiarize themselves with the COSMIN initiative. [ABSTRACT FROM AUTHOR]

• The AO-Trauma Italy council has encouraged the development of a national fracture registry in Italy (RIFra). • Thirteen AO-Trauma Italy members, chairmen of Level-I orthopaedic and trauma centres, diffused throughout Italy, were involved in the RIFra project. • The RIFra form, developed between November 2019 and March 2020, consists of 5 main sections, namely: epidemiologic data, previous surgical procedure (if any), patient and fracture features, surgical procedure, surgical implant details. • This study constitutes the first step to start, the bureaucratic procedure leading to the final establishment of a national fracture registry in Italy. In recent years, there has been an increasing interest in the development of arthroplasty registries, therefore, in our country, the Italian Arthroplasty Registry (RIAP), was issued by the National Law No. 221/2012. In the last decade, however, some European countries -namely Sweden, Denmark, Norway, and Germany (in development)- have introduced another nationwide orthopaedic registry than arthroplasty registers: the fracture registry. The development of this new tool aims to improve quality and safety in fracture management, thus trying to provide a better postoperative quality of life in trauma patients. Based on these findings, the AO-Trauma Italy Council encouraged the development of a national fracture registry in Italy. The present study aims to (1) provide an overview of the fracture registries in Europe and (2) to develop, for the first time, a pilot Italian Fracture Registry (RIFra). Thirteen AO-Trauma Italy members, chairmen of Level-I orthopaedic and trauma centres, diffused throughout Italy, were involved in the RIFra project. The RIFra form, developed between November 2019 and March 2020, consists of 5 main sections, namely: epidemiologic data, previous surgical procedure (if any), patient and fracture features, surgical procedure, surgical implant details. This study constitutes the first step to start, in future years, the bureaucratic procedure leading to the final establishment of a RIAP-like fracture registry in Italy. [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). [Display omitted] • PRO-CTCAE allow patients' self-reporting of adverse events. • Convergent validity of selected PRO-CTCAE items with HADS and BR-23 was good. • Responsiveness to patients' impression of change was good. [ABSTRACT FROM AUTHOR]

Patient and public involvement in health care is considered indispensable in the way we conduct daily pediatric neurology practice, and in the development and utilization of health outcome measurements. This essay examines what meaningful quality evaluations and measurements are, describes the development of approaches to measuring health and outcomes, explores the potential applications of patient-reported outcome measures in pediatric neurology, and identifies opportunities and challenges in using patient-reported outcome measurements in our daily clinical practice. Recent developments have transformed our attitude on how to help children with neurological and developmental conditions and their families: specifically, (1) the recognition of the fundamental rights of children with disabilities; (2) the application of the framework of the International Classification of Functioning, Disability and Health by the World Health Organization that views health from the perspective of both biopsychosocial strengths and functional abilities; (3) the application of qualitative research methodologies to children with neurological conditions and their caregivers to elucidate what they consider essential for their own good health and well-being; and (4) the development of core outcome measurements sets for children and adults with various neurological and developmental conditions. In summary, supporting patients in their role as full partners in clinical care and research enables them to contribute their experiential knowledge and helps ensure that results are relevant and address patient needs, preferences, and priorities. Recognizing the importance of involving young people in their health management decisions has become central in contemporary medicine and needs to be part of the curriculum of all health care professionals. [ABSTRACT FROM AUTHOR]

Patient-reported outcomes measures (PROMs) are an increasingly recognised end point of radiotherapy studies. We hypothesised that the baseline PROMs score is the strongest predictor for acute and late scores after treatment. We assessed the strength of association of baseline MD Anderson Symptom Inventory (MDASI) scores, alongside other known factors for patient- or clinician-reported toxicity, with acute (6-week) and late (12-month) scores in head and neck cancer (HNC) patients following (chemo)radiotherapy. This was a retrospective analysis of longitudinal MDASI scores for 247 patients receiving (chemo)radiotherapy for HNC via multivariable linear regression. The factors investigated were: baseline symptom score, age, sex, concurrent chemotherapy, disease stage, radiotherapy fractionation, prior definitive surgery and performance status. Patients with a baseline score >4 in any item were defined as symptomatic in that category. Patients rated symptomatic for an MDASI item pre-treatment on average reported statistically (P < 0.0005) and clinically (>–1.5) significant reductions in scores 6 weeks and 12 months after (chemo)radiotherapy for all considered sub-items except taste, dryness of mouth and problems with teeth. Conversely patients asymptomatic at baseline reported a worsening of scores at both time points. Other investigated factors showed little association with changes in MDASI scores following treatment. Our data show that baseline MDASI scores are strongly associated with patient-reported toxicity 6 weeks and 12 months after (chemo)radiotherapy for HNC. Patients who are symptomatic at baseline can experience an early and durable benefit from treatment. This finding can inform discussions with patients before therapy and has implications for use of PROMs scores for the assessment of toxicity in randomised trials. • Predictive factors for MDASI evolution after (chemo)radiotherapy for head and ceck cancer assessed. • Baseline MDASI score the only factor associated with score evolution up to 1 year post-therapy. • Symptomatic patients experience an early and durable benefit to symptoms from treatment. • Finding has implications use of patient-reported outcome measures as end points of clinical trials. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcome measures (PROMs) have recently been considered as indicating clinical outcomes after total hip arthroplasty (THA). Although various factors are reportedly associated with post-THA and PROMs, the relationship with gait parameters, which are objective assessment factors after THA, remains unclear.Research Question: What is the relationship between PROMs and gait biomechanical factors four weeks after THA?Methods: Forty-five patients (six men and 39 women) who underwent THA were included. Three-dimensional gait analysis was performed four weeks post-THA; joint angle, internal moment, and power of the lower extremity at the first and second peaks of the vertical component of the floor reaction force were assessed for the operated side. PROMs were evaluated using the Japanese Orthopedic Association Hip Disease Evaluation Questionnaire (JHEQ). The relationship between the JHEQ score and extracted gait parameters was analyzed using gender and gait speed as control factors.Results: For the JHEQ sub-domain, movement was positively correlated with the internal knee extension moment values at the first peak (r = 0.347). There was no significant correlation between JHEQ and the internal hip abduction moment value at the first peak. Mental status was negatively correlated with the hip flexion angle value at the second peak (r = -0.373), and positively correlated with the hip flexion moment value (r = 0.348). Total JHEQ scores and mental status were negatively correlated with the power of hip flexion value at the second peaks, respectively (r = -0.316, -0.444).Significance: The results of this study may provide recovery guidelines to be used as an index for gait assessment in the early post-THA period. Further studies are needed to verify whether gait parameters can improve PROMs in the early post-THA period. [ABSTRACT FROM AUTHOR]

Context: Breakthrough pain (BTP) is common in cancer and other conditions yet there is a lack of validated BTP measurement tools.Objectives: We aimed to identify all tools assessing or characterising BTP in patients of any age with any condition, and to critically appraise their psychometric properties.Methods: The Cochrane Library, PROSPERO, Embase, CINAHL, Medline, PsycINFO, Web of Science, Google Scholar, ProQuest, Evidence Search and OpenGrey were searched to identify all available tools used to assess BTP. A second search identified studies that had evaluated psychometric properties of tools identified in Search 1. Databases were searched from inception to November 2020. Studies were assessed using COSMIN criteria and GRADE guidelines.Results: Search 1 found 51 tools used to assess BTP. Search 2 found six tools that had a development study and/or a study evaluating a tool psychometric property. No tool had more than one study evaluating psychometric properties so a meta-analysis could not be conducted. Studies were of inadequate to very good quality. Only the Breakthrough Pain Assessment Tool (BAT) had sufficient content validity and at least low-quality evidence for sufficient internal consistency.Conclusion: The BAT is recommended to characterise BTP in adults with cancer; its applicability to other conditions is unknown. The remaining tools need further evaluation. Only the Breakthrough Pain Questionnaire for Children was designed for children with cancer, but no psychometric properties were evaluated. There is a need for a tool to assess and characterise BTP in children with non-cancer diagnoses and those who cannot self-report. [ABSTRACT FROM AUTHOR]

Several functional outcome scores have been proposed for the evaluation of shoulder instability. Most are multiple-item questionnaires, which can be time-consuming and difficult for patients to understand, as well as leading to lack of compliance. The Single Assessment Numeric Evaluation (SANE) score is a single question that has recently gained widespread acceptance based on its simplicity and correlation with more complex scoring systems. The purpose of this study was to assess the correlation of a new modified version of the SANE score, the SANE-instability score, with the Rowe score after treatment for shoulder instability. We prospectively evaluated a consecutive series of 253 patients (268 shoulders) treated surgically or nonoperatively for shoulder instability between November 2017 and November 2019, for whom the Rowe and SANE-instability scores were collected before treatment and/or after treatment. The SANE-instability score was assessed with the following question: "What is the overall percent value of your shoulder if a completely stable shoulder represents 100%?" Correlations were tested using the Pearson coefficient (r) and interpreted as very high (r = 0.90-1.00), high (r = 0.70-0.89), moderate (r = 0.50-0.69), low (r = 0.30-0.49), or negligible (r = 0.00-0.29). Subgroup analyses were also performed to observe correlation variations according to follow-up length (before treatment and at 6, 12, 26, 52, and 104 weeks after treatment), patient age (<20, 20-29, 30-39, or ≥40 years), and type of treatment (nonoperative or surgical). The overall correlation between the SANE-instability and Rowe scores was high (r = 0.85, P <.001). Subgroup analyses revealed that the correlation between the 2 scores was high before treatment (r = 0.74); moderate at 6 and 12 weeks after treatment (r = 0.66 and r = 0.57, respectively); and then high at 26, 52, and 104 weeks after treatment (r = 0.75, r = 0.75, and r = 0.78, respectively) (P <.001). The correlation was high across all types of treatment (r = 0.76-0.85), high for patients aged ≥ 20 years (r = 0.80-0.86), and very high for patients aged < 20 years (r = 0.93) (P <.001). This study demonstrated a significant correlation between the SANE-instability and Rowe scores before and after treatment, as well as across all patient age groups and treatments. Owing to its high simplicity, the SANE-instability score could be used as an alternative to the Rowe score for patient follow-up at various time points. [ABSTRACT FROM AUTHOR]

Objectives: Patient-reported outcomes are increasingly recommended to guide patient care, develop and evaluate interventions, and modify health systems. However, not enough is known about whether and how children and adolescents, as "experts" in their own health and quality of life (QoL), are being engaged in the development of instruments. Our goals in this review were (1) to identify all QoL-related instruments that have included children and/or adolescents in the development of questionnaire content, including identification of themes and items; and (2) to report how this was done; and (3) to highlight those that used qualitative methods.Methods: MEDLINE and Embase were searched for child- or adolescent-completed QoL-related instruments, supplemented by hand-searching of relevant reviews until 2020. Original development papers were identified and retrieved when possible, from which instrument characteristics and details of qualitative development methods were extracted.Results: We identified 445 instruments, of which 88 used qualitative methods for content development. Interviews and focus groups were the most common methods. A variety of play techniques were used to engage the child and adolescent participants. The specific criteria for the inclusion of children and adolescents (age, developmental stage, duration, and nonclinical location) varied considerably.Conclusions: Researchers frequently involve children and adolescents in qualitative methods when developing QoL-related measures; however, there is little information about the methods used. Better reporting of methodology, improved dissemination of methods guidelines, and research into optimal ways of including children and adolescents in the process of instrument development would be useful. [ABSTRACT FROM AUTHOR]

Older women are increasingly undergoing surgery for gynaecological malignancies. Although survival data is available other outcomes such as functional recovery are less well described. This systematic review and narrative synthesis describes functional recovery after gynaeoncology surgery with respect to baseline characteristics. Systematic search of MEDLINE and EMBASE databases and Cochrane Library between 1974 to 2018. Two reviewers independently reviewed abstracts/papers for inclusion against the following criteria: - mean/median patient age >60 - gynaeoncology surgery - preoperative, post-operative and change in function evaluated using any validated tool containing items measuring functional ability (defined by WHO International Classification of Function). Results analysed and presented using narrative synthesis. Fifteen studies identified (8 Endometrial, 2 Ovarian, 2 Vulval, 3 mixed cancer types). 1/15 used a standalone functional assessment tool, 14/15 used Health-Related Quality of Life tools (EORTC QLQ C30 (8), FACT-G (3), SF-36 (3)) comprising items describing function. More studies showed full recovery to baseline (n = 13) than incomplete recovery (n = 2). Four studies reported a negative association between older age and functional trajectory. Recovery was more likely and occurred faster in minimally-invasive surgery. Few studies reported baseline characteristics including cognition, frailty or comorbidities and none examined associations with functional recovery. There is inadequate data on functional recovery of older women following gynaeoncology surgery. Future studies are needed to identify factors associated with poorer/better outcomes. This may enable identification of opportunities for risk reduction, improve equity of access and better shared-decision making. • Anticipated functional outcome influences older women's treatment choices. • Lesser functional decline often associated with minimally invasive surgery. • Older age & low baseline function negatively impact postoperative functional return. • Frailty, multimorbidity and cognition not routinely measured in existing research. • Future research may identify potential targets for intervention and improvement. [ABSTRACT FROM AUTHOR]

• SiCaP-packed 3D-printed lamellar titanium cages were studied in TLIF and LLIF. • Solid fusion was achieved in 92/93 (98.9%) patients with good integration of cages. • Pain/disability scores decreased and quality of life improved 1 year post-surgery. The synthetic bone graft material, silicate-substituted calcium phosphate (SiCaP), has been successfully used in spinal fusion surgery. The efficacy of SiCaP-packed 3D-printed lamellar titanium cages used in transforaminal lumbar interbody fusion (TLIF) and lateral lumbar interbody fusion (LLIF) requires investigation. This study evaluated the efficacy of this combination in TLIF and LLIF surgeries treating adult spinal deformities and degenerative disorders. We retrospectively analysed a consecutive case series of 93 adult patients with lumbar degenerative disease or deformity requiring interbody cages who underwent TLIF or LLIF surgery with SiCaP-packed 3D-printed lamellar titanium cages, performed by a single lead surgeon. The primary endpoint was solid fusion 12 months after surgery, assessed using computed tomography. Secondary endpoints were patient-reported outcomes; EuroQOL five dimensions (EQ-5D), visual analogue scale (VAS) for pain (EQ-5D VAS), VAS pain scores for leg and back, and Oswestry disability index (ODI). Complications were recorded. Computed tomography revealed solid fusion in 92/93 (98.9%) patients with good cage integration at the vertebral body interface and no evidence of screw loosening. Patient-reported outcomes significantly improved for all parameters 1 year post-operation. Mean VAS significantly declined 1 year following TLIF surgery (back: −5.5; leg: −6.7) and following LLIF surgery (back: −5.9; leg: −6.9). Mean ODI declined 1 year following TLIF surgery (−43.0) from crippled to minimal disability and following LLIF surgery (−41.2) from severe to minimal disability. SiCaP-packed 3D-printed lamellar titanium cages provided excellent rates of solid fusion in TLIF and LLIF surgeries with notable improvements in patient-reported outcomes. [ABSTRACT FROM AUTHOR]

Preoperative risk assessment in vascular surgery often relies on the clinical subjectivity of providers and assessment tools with poor discrimination. Patient-reported outcome measures (PROMs) may provide a more objective assessment of an individual's own health status before surgery and ability to recover after a vascular procedure. We designed this study to determine whether PROMs assessed for physical function (PROM-PF) prior to vascular surgery could be used to predict patient risk for postoperative complications and delayed recovery. We identified all patients who completed a PROM-PF survey prior to undergoing a vascular surgery procedure captured in the Society for Vascular Surgery-Vascular Quality Initiative registry (carotid endarterectomy, abdominal aortic aneurysm, endovascular aneurysm repair, thoracic endovascular aneurysm repair, peripheral vascular intervention, infra-inguinal bypass, and supra-inguinal bypass) at a single academic institution between January 2016 and June 2020. PROM-PF assessment was obtained electronically using the validated Patient-Reported Outcome Measurement Information System short form (v1.2) instrument. All patient demographics and comorbidities were collected as part of the Society for Vascular Surgery-Vascular Quality Initiative registry. After stratifying patients based on high vs low preoperative PROM-PF, multivariable regression models were used to assess the risk-adjusted odds ratios (ORs) for perioperative complications, extended hospital length of stay (LOS), and discharge to a care facility. A total of 240 patients (mean age, 68 years; 69% male; and 88% Caucasian) completed a PROM-PF assessment <30 days before a vascular surgery intervention, of which 54% had low PF. Patients with high PF were more likely than those with low PF to undergo an open vascular procedure (43% high PF vs 42% low PF; P <.001). Rates of perioperative complications and/or mortality were similar between groups, although patients with low-PF were more likely to have an extended hospital LOS (48% low PF vs 33% high PF; P <.05) and/or be discharged to a care facility (17% low PF vs 7% high PF; P <.05). These results were confirmed in risk-adjusted models showing that patients with low PF scores were significantly more likely to have an extended LOS (adjusted OR, 1.86; 95% confidence interval, 1.06-3.28) and be discharged to a care facility (adjusted OR, 2.72; 95% confidence interval, 1.06-7.00). Low preoperative PROM-PF was associated with a higher risk of extended inpatient LOS and discharge to a care facility following vascular surgery. PROMs allow patients to provide valuable presurgical information about their own health status that can be used to anticipate postoperative recovery. [ABSTRACT FROM AUTHOR]

Background: The aim of this systematic review and meta-analysis was to compare the clinical and patient-reported outcome measures (PROMs) of medial stabilized total knee arthroplasty (TKA) with non-medial stabilized TKAs.Methods: A systematic search of multiple databases was conducted in October 2019. A meta-analysis was conducted for the Knee Society Score (KSS), Knee Society Functional Score (KFS), range of motion (ROM), Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and Forgotten Joint Score (FJS).Results: A total of 857 articles yielded 21 studies eligible for inclusion with 13 studies used for quantitative analysis. The meta-analysis revealed that the medial stabilized group had a mean FJS that was 13.8 points higher than that of the non-medial stabilized TKA (mean difference [MD]: 13.83, P ≤ .0001, 95% confidence interval [CI]: 8.90-18.76, I2 = 0%) which was less than the minimal clinically important difference of 14. The medial stabilized group also demonstrated a statistically significant difference in the postoperative ROM (MD = 2.52, P = .05, 95% CI: -0.03 to 5.07, I2 = 85%) and OKS when compared with the non-medial stabilized group (MD = 1.25, P = .02, 95% CI: 0.17-2.33, I2 = 27%), but these were not clinically significant. There was no statistically or clinically significant difference in the KSS, KFS, and WOMAC scores.Conclusion: Medial stabilized knee prostheses demonstrated no clinically significant differences for the ROM, OKS, WOMAC, KSS, and KFS. The FJS demonstrated the greatest MD and warrants further investigation. Future research is required using patient-reported outcome measures with a lower ceiling effect such as the FJS. [ABSTRACT FROM AUTHOR]

• A patient-reported outcome measure (PROM) was developed to measure communication and language in MS. • This new PROM is called the: Communication and Language Assessment questionnaire for persons with Multiple Sclerosis (CLAMS). • Psychometric analysis showed the CLAMS has satisfactory reliability and validity. • The CLAMS can be used in clinical practice and research studies. There is growing recognition that communication and language can be compromised in persons with multiple sclerosis (MS). However, patient-reported outcome measures (PROMs) designed to measure communication and language function in MS are currently lacking. This study aimed to develop and validate a novel PROM, the Communication and Language Assessment questionnaire for persons with Multiple Sclerosis (CLAMS). One-hundred and ninety-nine participants were recruited internationally through online channels. Participants completed an online questionnaire consisting of 41-items generated from the: (1) La Trobe Communication Questionnaire (LCQ), (2) Speech pathology-specific questionnaire for persons with Multiple Sclerosis (SMS), and (3) published research describing communication and language in MS. These items were then submitted to preliminary psychometric evaluation, including principal component analysis, internal consistency, test-retest reliability, criterion validity, and analyses of floor and ceiling effects. Criterion validity was assessed by comparing the CLAMS with the Communication Participation Item Bank (CPIB). The final CLAMS contained 11-items. Internal consistency was high (α = 0.944) and test-retest reliability. All items produced an intra-class correlation coefficient ≥ 0.70. No floor or ceiling effects were present. A statistically significant strong correlation between the CLAMS and the CPIB was identified (r = -0.750, p = ≤ 0.001). The CLAMS is a reliable and valid PROM that assesses self-perceived communication and language function in MS. This tool can be used for research and clinical purposes to measure intervention outcomes, monitor symptom evolution, evaluate service delivery, facilitate patient-centred care, and as an adjunct to clinical assessment. [ABSTRACT FROM AUTHOR]

Objective: Individuals with immune-mediated inflammatory disease (IMID) have a higher prevalence of psychiatric disorders than the general population. We utilized machine-learning to identify patient-reported outcome measures (PROMs) that accurately predict major depressive disorder (MDD) and anxiety disorder in an IMID population.Methods: Participants with IMID were enrolled in a cohort study and completed a Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID), and multiple PROMs. PROM items were ranked separately for MDD and anxiety disorder by the standardized mean difference between individuals with and without psychiatric disorders. Items were added sequentially to logistic regression (LR), neural network (NN), and random forest (RF) models. Discriminative performance was assessed with area under the receiver operator curve (AUC) and calibration was assessed with Brier scores. Ten-fold cross-validation was used.Results: Of 637 participants, 75% were female and average age was 51 years. AUC and Brier scores respectively ranged from 0.87-0.91 and 0.07 (i.e., no variation) for MDD models, and from 0.79-0.83 and 0.09-0.11 for anxiety disorder models. In LR and NN, few PROM items were required to obtain optimal discriminatory performance. RF did not perform as well as LR and NN when few PROM items were included.Conclusions: Predictive model performance was respectable and revealed insight into PROM items that are predictive of MDD and anxiety disorder. Models that included only the items 'I felt depressed' and 'I felt like I needed help for my anxiety' performed similarly to models that included all items from multiple PROMs. [ABSTRACT FROM AUTHOR]

Abstract: The Work, Osteoarthritis or joint-Replacement Questionnaire (WORQ) was developed to assess physical difficulty experienced in work before or following total knee arthroplasty (TKA). Thirteen questions were designed. The WORQ was tested for internal consistency by factor analysis, internal reliability (Crohnbach's α), and construct validity. A test–retest reproducibility was performed for analyzing standard error of measurement (SEM agreement), reliability (ICC) and smallest detectable change (SDC) in individuals and groups. Lastly responsiveness (standardized response means [SRM]), floor and ceiling effects and interpretability (minimal important change [MIC]) were analyzed. It is shown that the WORQ is a reliable, valid and responsive questionnaire that can be used to evaluate the impact of knee complaints following TKA on patients' ability to work. [Copyright &y& Elsevier]