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Background: Approximately 3 million people in the United Kingdom are currently living with or beyond cancer. People undergoing treatment for cancer are at risk of complications following treatment. Increasing evidence supports the role of rehabilitation (including prehabilitation) in enhancing psychological and physical well-being in patients with cancer and improving outcomes. Active Together is an evidence-based, multimodal rehabilitation service for patients with cancer, providing support to help patients prepare for and recover from treatment. This paper presents the evaluation protocol for the Active Together service, aiming to determine its impact on patient-reported outcomes and clinical endpoints, as well as understand processes and mechanisms that influence its delivery and outcomes. Methods: This evaluation comprises an outcome and process evaluation, with service implementation data integrated into the analysis of outcome measures. The outcome evaluation will assess changes in outcomes of patients that attend the service and compare health care resource use against historical data. The process evaluation will use performance indicators, semistructured interviews, and focus groups to explore mechanisms of action and contextual factors influencing delivery and outcomes. Integrating psychological change mechanisms with outcome data might help to clarify complex causal pathways within the service. Conclusions: Evidence to support the role of multimodal rehabilitation before, during, and after cancer treatment is increasing. The translation of that evidence into practice is less advanced. Findings from this evaluation will contribute to our understanding of the real-world impact of cancer rehabilitation and strengthen the case for widespread adoption of rehabilitation into routine care for people with cancer. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To evaluate the role of psychosocial well-being on perioperative pain and opioid use among patients with cleft lip and palate (CLP) undergoing alveolar bone grafting (ABG). DESIGN: Retrospective review. SETTING: Tertiary level craniofacial clinic. PARTICIPANTS: 34 patients with CLP (median age: 11.7 years), including 25 (73.5%) unilateral CLP and 9 (26.5%) bilateral CLP, who underwent ABG from 2015 to 2022. INTERVENTIONS: ABG using iliac crest bone graft. Patients were prospectively administered four patient-reported psychosocial instruments from the Patient-Reported Outcomes Measurement Information System. MAIN OUTCOME MEASURES: Perioperative opioid use in morphine equivalent dosage/kilogram, patient-reported pain scores, and length of hospital stay after ABG. RESULTS: Patient-reported anxiety (r = 0.41, p = 0.02) and depressive symptoms (r = 0.35, p = 0.04) correlated to higher perioperative opioid usage. Multivariable regression models including psychosocial scores, total acetaminophen usage, length of surgery, and other simultaneous surgeries were developed for total opioid usage, patient-reported pain, and length of hospital stay. Patient-reported anxiety was independently predictive of higher perioperative opioid use (β=0.36, p = 0.01) and higher pain scores (β=0.39, p = 0.02), but not length of hospital stay. CONCLUSIONS: We identified an association for patient-reported anxiety and perioperative opioid use and pain in a CLP cohort undergoing ABG. Future considerations in preoperative patient and family consultation may be indicated in patients self-reporting higher anxiety in an effort to minimize perioperative opioid usage.

BackgroundIn contrast to prior research, our study presents longitudinal comparisons of the EQ-5D-5L and Patient-Reported Outcomes Measurement Information System (PROMIS) preference (PROPr) scores. This fills a gap in the literature, providing a much-needed understanding of these preference-based measures and their applications in healthcare research. Furthermore, our study provides equations to estimate one measure from the other, a tool that can significantly facilitate comparisons across studies.MethodsWe administered a health survey to 4,098 KnowledgePanel® members living in the United States. A subset of 1,256 (82% response rate) with back pain also completed the six-month follow-up survey. We then conducted thorough cross-sectional and longitudinal analyses of the two measures, including product-moment correlations between scores, associations with demographic variables, and health conditions. To estimate one measure from the other, we used ordinary least squares (OLS) regression with the baseline data from the general population.ResultsThe correlation between the EQ-5D-5L and PROPr scores was 0.69, but the intraclass correlation was only 0.34 because the PROPr had lower (less positive) mean scores on the 0 (dead) to 1 (perfect health) continuum than the EQ-5D-5L. The associations between the two preference measures and demographic variables were similar at baseline. The product-moment correlation between unstandardized beta coefficients for each preference measure regressed on 22 health conditions was 0.86, reflecting similar patterns of unique associations. Correlations of change from baseline to 6 months in the two measures with retrospective perceptions of change were similar. Adjusted variance explained in OLS regressions predicting one measure from the other was 48%. On average, the predicted values were within a half-standard deviation of the observed EQ-5D-5L and PROPr scores. The beta-binomial regression model slightly improved over the OLS model in predicting the EQ-5D-5L from the PROPr but was equivalent to the OLS model in predicting the PROPr.ConclusionDespite substantial mean differences, the EQ-5D-5L and PROPr have similar cross-sectional and longitudinal associations with other variables. We provide the OLS regression equations for use in cost-effectiveness research and meta-analyses. Future studies are needed to compare these measures with different conditions and interventions to provide more information on their relative validity.

PurposeLongitudinal patient tolerability data collected as part of randomized controlled trials are often summarized in a way that loses information and does not capture the treatment experience. To address this, we developed an interactive web application to empower clinicians and researchers to explore and visualize patient tolerability data.MethodsWe used adverse event (AE) data (Common Terminology Criteria for Adverse Events) and patient-reported outcomes (PROs) from the NSABP-B35 phase III clinical trial, which compared anastrozole with tamoxifen for breast cancer-free survival, to demonstrate the tools. An interactive web application was developed using R and the Shiny web application framework that generates Sankey diagrams to visualize AEs and PROs using four tools: AE Explorer, PRO Explorer, Cohort Explorer, and Custom Explorer.ResultsTo illustrate how users can use the interactive tool, examples for each of the four applications are presented using data from the NSABP-B35 phase III trial and the NSABP-B30 trial for the Custom Explorer. In the AE and PRO explorers, users can select AEs or PROs to visualize within specified time periods and compare across treatments. In the cohort explorer, users can select a subset of patients with a specific symptom, severity, and treatment received to visualize the trajectory over time within a specified time interval. With the custom explorer, users can upload and visualize structured longitudinal toxicity and tolerability data.ConclusionWe have created an interactive web application and tool for clinicians and researchers to explore and visualize clinical trial tolerability data. This adaptable tool can be extended for other clinical trial data visualization and incorporated into future patient-clinician interactions regarding treatment decisions.

PurposeAnterior urethral stricture disease (aUSD) is a complex, heterogeneous condition that is idiopathic in origin for most men. This gap in knowledge rarely affects the current management strategy for aUSD, as urethroplasty does not generally consider etiology. However, as we transition towards personalized, minimally invasive treatments for aUSD and begin to consider aUSD prevention strategies, disease pathophysiology will become increasingly important. The purpose of this study was to perform a deep phenotype of men undergoing anterior urethroplasty for aUSD. We hypothesized that unique biologic signatures and potential targets for intervention would emerge based on stricture presence/absence, stricture etiology, and the presence/absence of stricture inflammation.Materials and methodsMen with aUSD undergoing urethroplasty were recruited from one of 5 participating centers. Enrollees provided urethral stricture tissue and blood/serum on the day of surgery and completed patient-reported outcome measure questionnaires both pre- and postoperatively. The initial study had 3 aims: (1) to determine pediatric and adult subacute and repeated perineal trauma (SRPT) exposures using a study-specific SRPT questionnaire, (2) to determine the degree of inflammation and fibrosis in aUSD and peri-aUSD (normal urethra) tissue, and (3) to determine levels of systemic inflammatory and fibrotic cytokines. Two controls groups provided serum (normal vasectomy patients) and urethral tissue (autopsy patients). Cohorts were based on the presence/absence of stricture, by presumed stricture etiology (idiopathic, traumatic/iatrogenic, lichen sclerosus [LS]), and by the presence/absence of stricture inflammation.ResultsOf 138 enrolled men (120 tissue/serum; 18 stricture tissue only), 78 had idiopathic strictures, 33 had trauma-related strictures, and 27 had LS-related strictures. BMI, stricture length, and stricture location significantly differed between cohorts (P < .001 for each). The highest BMIs and the longest strictures were observed in the LS cohort. SRPT exposures did not significantly differ between etiology cohorts, with > 60% of each reporting low/mild risk. Stricture inflammation significantly differed between cohorts, with mild to severe inflammation present in 27% of trauma-related strictures, 54% of idiopathic strictures, and 48% of LS strictures (P = .036). Stricture fibrosis did not significantly differ between cohorts (P = .7). Three serum cytokines were significantly higher in patients with strictures compared to stricture-free controls: interleukin-9 (IL-9; P = .001), platelet-derived growth factor-BB (P = .004), and CCL5 (P = .01). No differences were observed in the levels of these cytokines based on stricture etiology. However, IL-9 levels were significantly higher in patients with inflamed strictures than in patients with strictures lacking inflammation (P = .019). Degree of stricture inflammation positively correlated with serum levels of IL-9 (Spearman's rho 0.224, P = .014).ConclusionsThe most common aUSD etiology is idiopathic. Though convention has implicated SRPT as causative for idiopathic strictures, here we found that patients with idiopathic strictures had low SRPT rates that were similar to rates in patients with a known stricture etiology. Stricture and stricture-adjacent inflammation in idiopathic stricture were similar to LS strictures, suggesting shared pathophysiologic mechanisms. IL-9, platelet-derived growth factor-BB, and CCL5, which were elevated in patients with strictures, have been implicated in fibrotic conditions elsewhere in the body. Further work will be required to determine if this shared biologic signature represents a potential mechanism for an aUSD predisposition.

BACKGROUND: Primary sclerosing cholangitis (PSC) is a progressive immune-mediated liver disease, for which no medical therapy has been shown to slow disease progression. However, the horizon for new therapies is encouraging, with several innovative clinical trials in progress. Despite these advancements, there is considerable heterogeneity in the outcomes studied, with lack of consensus as to what outcomes to measure, when to measure and how to measure. Furthermore, there has been a paradigm shift in PSC treatment targets over recent years, moving from biochemistry-based endpoints to histological assessment of liver fibrosis, imaging-based biomarkers and patient-reported outcome measures. The abundance of new interventional trials and evolving endpoints pose opportunities for all stakeholders involved in evaluating novel therapies. To this effect, there is a need to harmonise measures used in clinical trials through the development of a core outcome set (COS). METHODS AND ANALYSIS: Synthesis of a PSC-specific COS will be conducted in four stages. Initially, a systematic literature review will be performed to identify outcomes previously used in PSC trials, followed by semistructured qualitative interviews conducted with key stakeholders. The latter may include patients, clinicians, researchers, pharmaceutical industry representatives and healthcare payers and regulatory agencies, to identify additional outcomes of importance. Using the outcomes generated from the literature review and stakeholder interviews, an international two-round Delphi survey will be conducted to prioritise outcomes for inclusion in the COS. Finally, a consensus meeting will be convened to ratify the COS and disseminate findings for application in future PSC trials. ETHICS AND DISSEMINATION: Ethical approval has been granted by the East Midlands-Leicester Central Research Ethics Committee (Ref: 24/EM/0126) for this study. The COS from this study will be widely disseminated including publication in peer-reviewed journals, international conferences, promotion through patient-support groups and made available on the Core Outcomes Measurement in Effectiveness Trials (COMET) database. TRIAL REGISTRATION NUMBER: 1239.

ObjectivesThis study aimed to explore the acceptability, feasibility, usability, and preliminary effect of an electronic patient-reported outcome (ePRO) intervention for patients with breast cancer in Mexico.DesignWe conducted a multimethod non-randomised pilot study. We used a pre-test/post-test design for quantitative assessment of the intervention's effect on patients' supportive care needs and quality of life. We conducted in-depth interviews (IDIs) with participants and healthcare workers to explore the intervention's benefits and barriers and understand its feasibility.Participants50 women aged 20-75 diagnosed with stage I-III breast cancer were enrolled within 2 weeks of starting neoadjuvant or adjuvant treatment with chemotherapy or radiotherapy. We excluded illiterate women and those with visual impairment, cognitive disability or severe depression. IDIs were conducted with 18 participants and 10 healthcare providers.SettingOncology services in three public hospitals of the Mexican Social Security Institute.InterventionThe ePRO intervention consisted of a responsive web application for weekly symptom reporting combined with proactive follow-up by nurses guided by predefined clinical algorithms for 6 weeks.Results50 women were enrolled out of 66 eligible patients approached (75.8%). All 50 completed the 4-week follow-up assessment (100% retention). Completion of the symptom registry declined from 100% in week 1 to 66% in week 6. Participants experienced decreases in supportive care needs and increased quality of life. The ePRO application was rated highly usable. Participants and health professionals both perceived intervention benefits. Drawbacks included poor fit for women receiving radiotherapy and challenges using the application for women with low digital literacy or experiencing severe symptoms.ConclusionsThis pilot study provided evidence of the high usability and potential efficacy of a web-based ePRO intervention. We revised recruitment during the pilot to include multiple facilities, and we will further revise for the randomised trial to address barriers to successful ePRO implementation.Trial registration numberClinicalTrials.gov ID: NCT05925257.

INTRODUCTION: Person-centred care (PCC) is provision of care that is respectful of and responsive to individual patient preferences, needs and values, and ensures that patient values guide all clinical decisions. While there is a large body of evidence on the benefits of PCC in high-income countries, little research exists on PCC in Ghana and Sub-Saharan Africa at large. Most studies on PCC have focused on maternity care as part of the global movement of respectful maternity care. The few studies on patient experiences and health system responsiveness beyond maternal health also highlight gaps in patient experience and satisfaction as well as discrimination in health facilities, which leads to the most vulnerable having the poorest experiences. The protocol for this scoping review aims to systematically map the extent of literature focused on PCC in Ghana by identifying patient expectations and preferences, barriers and facilitators, and interventions. METHODS AND ANALYSIS: The protocol will be guided by the Arksey and OMalley methodological framework and recommendations by Levac et al. A comprehensive search strategy will be used to search for published articles in PubMed, EMBASE, Web of Science and the African Journals Online from their inception to August 2022. Grey literature and reference lists of included studies will also be searched. Two independent reviewers will perform the literature search, eligibility assessments and study selection. Any disagreements will be resolved through discussion with a third reviewer. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses flow diagram for the scoping reviews will be used to outline the study selection process. Extracted data from the included articles will be synthesised and reported under key concepts derived from the outcomes of the scoping review. ETHICS AND DISSEMINATION: This scoping review does not require ethical approval. The findings will be disseminated through publications and conference presentations. SCOPING REVIEW REGISTRATION: OSF Registration DOI 10.17605/OSF.IO/ZMDH9.

BACKGROUND: This post-hoc retrospective study describes long-term patient-reported outcomes (PROs) for REarranged during Transfection (RET)-altered non-small-cell lung cancer (NSCLC), medullary thyroid cancer (MTC), non-MTC thyroid cancer (TC), and tumor agnostic (TA) patients (Data cut-off: January 2023) from the LIBRETTO-001 trial. PATIENTS AND METHODS: Patients completed the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30). Patients with MTC also completed a modified version of the Systemic Therapy-Induced Diarrhea Assessment Tool (mSTIDAT). The proportion of patients with improved, stable, or worsened status after baseline was reported. PROs were summarized at 3 years (cycle 37) post-baseline for the NSCLC and MTC cohorts, and at 2 years (cycle 25) post-baseline for the TC and TA cohorts. Time-to-event outcomes (time to first improvement or worsening and duration of improvement) were reported. RESULTS: The baseline assessment was completed by 200 (63.3%), 209 (70.8%), 50 (76.9%), and 38 (73.1%) patients in the NSCLC, MTC, TC, and TA cohorts, respectively. The total compliance rate was 80%, 82%, 70%, and 85%, respectively. Approximately 75% (NSCLC), 81% (MTC), 75% (TC), and 40% (TA) of patients across all cohorts reported improved or stable QLQ-C30 scores at year 3 (NSCLC and MTC) or year 2 (TC and TA) with continuous selpercatinib use. Across cohorts, the median time to first improvement ranged from 2.0 to 19.4 months, the median duration of improvement ranged from 1.9 to 28.2 months, and the median time to first worsening ranged from 5.6 to 44.2 months. The total compliance rate for the mSTIDAT was 83.7% and the proportion of patients with MTC who reported diarrhea on the mSTIDAT was reduced from 80.8% at baseline to 35.6% at year 3. CONCLUSIONS: A majority of patients with RET-driven cancers improved or remained stable on most QLQ-C30 domains, demonstrating favorable health-related quality of life as measured by the QLQ-C30 during long-term treatment with selpercatinib.

PURPOSE: Locally advanced/metastatic urothelial cancer (la/mUC) affects patients quality of life (QOL) and functioning. We describe the impact of first-line (1L) enfortumab vedotin (EV) alone or with pembrolizumab (P) on QOL/functioning/symptoms in patients with la/mUC who were cisplatin-ineligible from EV-103 Cohort K. METHODS: In this phase Ib/II trial, patients were randomly assigned 1:1 to EV + P or EV monotherapy (mono). Exploratory patient-reported outcomes (PROs) were assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core Questionnaire (EORTC QLQ-C30) and Brief Pain Inventory Short Form (BPI-SF) at baseline, once per week for cycles 1-3, and then in every cycle through the end of treatment. Changes in scores from baseline to week 24, reported as least squares mean (standard error), were assessed by mixed models for repeated measures. There were no formal statistical comparisons between treatment arms. RESULTS: Of 149 patients treated, 65 (EV + P) and 63 (EV mono) comprised the PRO analysis set. For EV + P, EORTC QLQ-C30 QOL was maintained through week 24 with improvements in emotional functioning, pain, and insomnia. Clinically meaningful improvements were seen in EORTC QLQ-C30 pain after EV + P at weeks 12 (-14.41 [3.14]) and 24 (-14.99 [3.56]) and BPI-SF worst pain at week 24 (-2.07 [0.37]). For EV mono, EORTC QLQ-C30 QOL remained stable with clinically meaningful improvements in EORTC QLQ-C30 pain (-12.55 [4.27]), insomnia (-14.46 [4.69]), and constipation (-10.09 [4.35]) at week 24. There were small-to-moderate improvements in BPI-SF worst pain at week 24. CONCLUSION: EV + P in patients with la/mUC who were cisplatin-ineligible was associated with preservation or improvement of QOL/functioning/symptoms. Improvement in pain was seen in both PRO instruments and treatment arms. These data complement clinical outcomes of 1L EV + P.

PURPOSE: The OlympiA randomized phase III trial compared 1 year of olaparib (OL) or placebo (PL) as adjuvant therapy in patients with germline BRCA1/2, high-risk human epidermal growth factor receptor 2-negative early breast cancer after completing (neo)adjuvant chemotherapy ([N]ACT), surgery, and radiotherapy. The patient-reported outcome primary hypothesis was that OL-treated patients may experience greater fatigue during treatment. METHODS: Data were collected before random assignment, and at 6, 12, 18, and 24 months. The primary end point was fatigue, measured with the Functional Assessment of Chronic Illness Therapy-Fatigue scale. Secondary end points, assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 item, included nausea and vomiting (NV), diarrhea, and multiple functional domains. Scores were compared between treatment groups using mixed model for repeated measures. Two-sided P values

AIM: This paper describes the trajectory during 1 year of four patient-reported outcomes (PROs), namely, sleep, depressive symptoms, health-related quality of life (HrQoL), and well-being, in patients with heart failure (HF), their relationship and the patient characteristics associated with changes in these PROs. METHODS AND RESULTS: Data analyses of PROs from 603 patients (mean age 67 years; 29% female, 60% NYHA II) enrolled in the HF-Wii study. On short term, between baseline and 3 months, 16% of the patients experienced continuing poor sleep, 11% had sustained depressive symptoms, 13% had consistent poor HrQoL, and 13% consistent poor well-being. Across the entire 1-year period only 21% of the patients had good PRO scores at all timepoints (baseline, 3, 6, and 12 months). All others had at least one low score in any of the PROs at some timepoint during the study. Over the 12 months, 17% had consistently poor sleep, 17% had sustained symptoms of depression, 15% consistently rated a poor HrQoL, and 13% poor well-being. Different patient characteristics per PRO were associated with a poor outcomes across the 12 months. Age, education, New York Heart Association, and length of disease were related to two PRO domains and submaximal exercise capacity (6 min test), co-morbidity, and poor physical activity to one. CONCLUSION: In total, 79% of the patients with HF encountered problems related to sleep, depressive symptoms, HrQoL, and well-being at least once during a 1-year period. This underscores the need for continuous monitoring and follow-up of patients with HF and the need for dynamic adjustments in treatment and care regularly throughout the HF trajectory.

PURPOSE: The Patient-Reported Outcomes Measurement and Information System (PROMIS®): includes the PROMIS-29 physical and mental health summary and the PROMIS global physical and mental health scores. It is unknown how these scores coincide with one another. This study examines whether the scores yield similar or different information. METHODS: The PROMIS-29 and the PROMIS global health items were administered to 5804 adults from Amazons Mechanical Turk (MTurk) in 2021-2022 and to 4060 adults in the Ipsos KnowledgePanel (KP) in 2022. RESULTS: The median age of those in MTurk (KP) was 36 (54) and 53% (50%) were male. Mean T-scores on the PROMIS-29 and PROMIS global physical health scales were similar, but PROMIS global mental health was 3-4 points lower than the PROMIS-29 mental health summary score. Product-moment correlations ranged from 0.69 to 0.81 between the PROMIS-29 physical health and PROMIS global physical health scales and 0.56-0.69 between the mental health scales. Multi-trait multimethod analyses indicated that only a small proportion of the correlations between the two methods of measuring mental health were significantly more highly correlated with one another than correlations between physical and mental health. CONCLUSIONS: PROMIS-29 and PROMIS global mental health scales provide different information and, therefore, study conclusions may vary depending on which measure is used. Interpretation of results needs to consider that the PROMIS-29 mental health scale is a weighted combination of specific domains while the PROMIS global mental health scale is based on general mental health perceptions. Further comparisons of methods of assessing mental health are needed.

BACKGROUND: Dental Patient Reported Outcomes (PROs) relate to a dental patients subjective experience of their oral health. How practitioners and patients value PROs influences their successful use in practice. METHODS: Semi-structured interviews were conducted with 22 practitioners and 32 patients who provided feedback on using a mobile health (mHealth) platform to collect the pain experience after dental procedures. A themes analysis was conducted to identify implementation barriers and facilitators. RESULTS: Five themes were uncovered: (1) Sense of Better Care. (2) Tailored Follow-up based on the dental procedure and patients pain experience. (3) Effective Messaging and Alerts. (4) Usable Digital Platform. (5) Routine mHealth Integration. CONCLUSION: Frequent automated and preferably tailored follow-up messages using an mHealth platform provided a positive care experience for patients, while providers felt it saved them time and effort. Patients thought that the mHealth questionnaires were well-developed and of appropriate length. The mHealth platform itself was perceived as user-friendly by users, and most would like to continue using it. PRACTICAL IMPLICATIONS: Patients are prepared to use mobile phones to report their pain experience after dental procedures. Practitioners will be able to close the post-operative communication gap with their patients, with little interruption of their workflow.

BackgroundTools, such as the STarTBack Screening Tool (SBT), have been developed to identify risks of progressing to chronic disability in low back pain (LBP) patients in the primary care population. However, less is known about predictors of change in function after treatment in the specialty care population.ObjectiveWe pursued a retrospective observational cohort study involving LBP patients seen in a multidisciplinary specialty clinic to assess which features can predict change in function at follow-up.MethodsThe SBT was administered at initial visit, and a variety of patient characteristics were available in the chart including the presence of chronic overlapping pain conditions (COPCs). Patient Reported Outcomes Measurement Information System-10 (PROMIS-10) global physical health (PH) and global mental health (MH) were measured at baseline and at pragmatic time points during follow-up. Linear regression was used to estimate adjusted associations between available features and changes in PROMIS scores.Results241 patients were followed for a mean of 17.0 ± 7.5 months. Mean baseline pain was 6.7 (SD 2.1), PROMIS-10 global MH score was 44.8 (SD 9.3), and PH score was 39.4 (SD 8.6). 29.7% were low-risk on the SBT, 41.8% were medium-risk, and 28.5% were high-risk. Mean change in MH and PH scores from baseline to the follow-up questionnaire were 0.86 (SD 8.11) and 2.39 (SD 7.52), respectively. Compared to low-risk patients, high-risk patients had a mean 4.35 points greater improvement in their MH score (p= 0.004) and a mean 3.54 points greater improvement in PH score (p= 0.006). Fewer COPCs also predicted greater improvement in MH and PH.ConclusionsSBT and the presence of COPC, which can be assessed at initial presentation to a specialty clinic, can predict change in PROMIS following treatment. Effort is needed to identify other factors that can help predict change in function after treatment in the specialty care setting.

OBJECTIVE: To investigate the feasibility of pre- and post-encounter patient-reported outcome (PRO) measure collection within an outpatient integrative health and medicine (IHM) clinic and to characterize factors associated with successful completion. METHODS: We conducted a retrospective review of 27,464 outpatient IHM encounters including 9,520 chiropractic; 8,237 acupuncture; 5,847 massage; 2,345 IHM consultation; and 1,515 osteopathic manipulation treatment encounters at four clinics offering IHM over 18 months. Patients were asked to complete paper questionnaires rating pain, anxiety, and stress from 0-10 immediately pre- and post-encounter. Generalized linear mixed effect regression models were used to examine the relationship between demographic, clinical, and operational covariates and completing (1) pre-encounter and (2) paired (i.e., pre and post) PROs. RESULTS: Patients (N = 5587, mean age 49 years, 74% white, 77% female) generally presented for musculoskeletal conditions (81.7%), with a chief complaint of pain (55.1%). 21,852 (79.6%) encounters were among patients who completed pre-encounter PROs; 11,709/21,852 (53.6%) completed subsequent post-encounter PROs. Odds of PRO completion were more impacted by provider, operational, and clinical-level factors than patient factors. Covariates associated with increased odds of pre-encounter PRO completion included being female, having additional IHM encounters, and having a pain or anxiety complaint. Covariates associated with increased odds of paired PRO completion included being aged 31-40 vs. 51-60 years and having additional IHM encounters. CONCLUSION: Implementing a paper-based PRO collection system in outpatient IHM is feasible; however, collecting post-encounter PROs was challenging. Future endeavors should leverage the electronic health record and patient portals to optimize PRO collection and engage patients and clinical providers.

BACKGROUND: Acupuncture and chiropractic care are evidence-based pain management alternatives to opioids. The Veterans Health Administration (VA) provides this care in some VA facilities, but also refers patients to community providers. We aimed to determine if patient-reported outcomes differ for acupuncture and chiropractic care from VA versus community providers. MATERIALS AND METHODS: We conducted an observational study using survey outcome data and electronic medical record utilization data for acupuncture and chiropractic care provided in 18 VA facilities or in community facilities reimbursed by VA. Study participants were users of VA primary care, mental health, pain clinic, complementary and integrative therapies, coaching or education services in 2018-2019. Patients received 1) 4+ acupuncture visits (N = 201) or 4+ chiropractic care visits (N = 178) from a VA or community provider from 60 days prior to baseline to six-months survey and 2) no acupuncture or chiropractic visits from 1 year to 60 days prior to baseline. Outcomes measured included patient-reported pain (PEG) and physical health (PROMIS) at baseline and six-month surveys. Multivariate analyses examined outcomes at six months, adjusting for baseline outcomes and demographics. RESULTS: In unadjusted analyses, pain and physical health improved for patients receiving community-based acupuncture, while VA-based acupuncture patients experienced no change. Unadjusted analyses also showed improvements in physical health, but not pain, for patients receiving VA-based chiropractic care, with no changes for community-based chiropractic care patients. Using multivariate models, VA-based acupuncture was no different from community-based acupuncture for pain (-0.258, p = 0.172) or physical health (0.539, p = 0.399). Similarly, there were no differences between VA- and community-based chiropractic care in pain (-0.273, p = 0.154) or physical health (0.793, p = 0.191). CONCLUSIONS: Acupuncture and chiropractic care were associated with modest improvements at six months, with no meaningful differences between VA and community providers. The choice to receive care from VA or community providers could be based on factors other than quality, like cost or convenience.

Purpose: Outcome measurement provides clinicians, services and funders with useful information. However, little is known about the experience of participating in outcome measurement during lower limb prosthetic rehabilitation from the patient's perspective. Materials and methods: Thirty-two participants who underwent lower limb amputation within 5 years, and had experience of taking part in outcome measurement during prosthetic rehabilitation, were recruited from UK limb fitting centers and social media. Data were collected using focus groups and interviews and analysed using reflexive thematic analysis. Results: Four themes were identified. (1) How does participating in outcome measurement make me feel? (2) Do the outcome measures used in routine clinical care capture an accurate picture of my recovery? (3) Who is outcome measurement for? and (4) are prosthetic services measuring what is meaningful? These themes suggest outcome measurement is not a neutral activity for patients following lower limb amputation. Conclusions: Harnessing the positive impacts of measuring outcomes could be used for motivation, to support adjustment and recovery, to improve communication and to support shared decision-making. This could make outcome measurement more meaningful and patient-centered. However, there may be potential for patients to respond negatively to outcome measures and clinicians should consider their impact on psychosocial factors. IMPLICATIONS FOR REHABILITATION: Outcome measurement in prosthetic rehabilitation can provide clinicians, service providers and funders with important information. Adopting a patient-centred approach could make the process more meaningful and therefore beneficial for patients themselves. Measuring what is important to patients by considering a holistic approach beyond physical domains may make outcome measurement more meaningful. Patient centred approaches may include talking to patients about outcome measurement, using it to support motivation, goal setting and decision-making, as well as exploring outcome ranges to account for, or even capture variability. However, the potential for negative responses should not be overlooked, and clinicians should consider the psychosocial impact of outcome measurement on this patient group, especially when using performance-based measures. [ABSTRACT FROM AUTHOR]

Study Design. Retrospective review. Objective. The purpose of this study was to evaluate disparities in patient-reported outcome measures (PROM) completion rates and baseline function scores among newly presenting spine patients. Summary of Background Data. Prior studies have demonstrated that minority patients and those of low socioeconomic status may present with worse physical and mental health on PROMs. As PROMs are increasingly used in clinical care, research, and health policy, accurate assessment of health status among populations relies on the successful completion of PROM instruments. Methods. A retrospective review of 10, 803 consecutive new patients presenting to a single multidisciplinary spine clinic from June 2020 to September 2022 was performed. Univariate statistics were performed to compare demographics between patients who did and did not complete PROMs. Multivariable analysis was used to compare PROM instrument completion rates by race, ethnicity, and Social Vulnerability Index (SVI) and baseline scores among responders. Results. A total of 68.4% of patients completed PROMs at the first clinic visit. After adjusting for age, sex, body mass index, and diagnosis type, patients of non-White race (OR = 0.661, 95% CI = 0.599-0.729, P < 0.001), Hispanic ethnicity (OR = 0.569, 95% CI = 0.448-0.721, P < 0.001), and increased social vulnerability (OR = 0.608, 95% CI = 0.511-0.723, P < 0.001) were less likely to complete PROMs. In the multivariable models, patients of non-White race reported lower levels of physical function (β = -6.5, 95% CI = -12.4 to -0.6, P = 0.032) and higher levels of pain intensity (β = 0.6, 95% CI = 0.2-1.0, P = 0.005). Hispanic ethnicity (β = 1.5, 95% CI = 0.5-2.5, P = 0.004) and increased social vulnerability (β = 1.1, 95% CI = 0.4-1.8, P = 0.002) were each associated with increased pain intensity. Conclusions. Among newly presenting spine patients, those of non-White race, Hispanic ethnicity, and with increased social vulnerability were less likely to complete PROMs. As these subpopulations also reported worse physical function or pain intensity, additional strategies are needed to better capture patient- reported health status to avoid bias in clinical care, outcomes research, and health policy. Level of Evidence. 4. [ABSTRACT FROM AUTHOR]

Study Design. Multicenter, prospective registry study. Objective. To clarify minimal clinically important differences (MCIDs) for surgical interventions for spinal metastases, thereby enhancing patient care by integrating quality of life assessments with clinical outcomes. Background. Despite its proven usefulness in degenerative spinal diseases and deformities, the MCID remains unexplored regarding surgery for spinal metastases. Patients and Methods. This study included 171 (out of 413) patients from the multicenter "Prospective Registration Study on Surgery for Metastatic Spinal Tumors" by the Japan Association of Spine Surgeons. These were evaluated preoperatively and at 6 months postoperatively using the Face Scale, EuroQol-5 Dimensions-5 Levels (EQ-5D-5L), including the Visual Analog Scale, and performance status. The MCIDs were calculated using an anchor-based method, classifying participants into the improved, unchanged, and deteriorated groups based on the Face Scale scores. Focusing on the improved and unchanged groups, the change in the EQ-5D-5L values from before to after treatment was analyzed, and the cutof f value with the highest sensitivity and specificity was determined as the MCID through receiver operating characteristic curve analysis. The validity of the MCIDs was evaluated using a distribution-based calculation method for patient-reported outcomes. Results. The improved, unchanged, and deteriorated groups comprised 121, 28, and 22 participants, respectively. The anchor-based MCIDs for the EQ-5D-5L index, EQ-Visual Analog Scale, and domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression were 0.21, 15.50, 1.50, 0.50, 0.50, 0.50, and 0.50, respectively; the corresponding distribution-based MCIDs were 0.17, 15, 99, 0.77, 0.80, 0.78, 0.60, and 0.70, respectively. Conclusion. We identified MCIDs for surgical treatment of spinal metastases, providing benchmarks for future clinical research. By retrospectively examining whether the MCIDs are achieved, factors favoring their achievement and risks affecting them can be explored. This could aid in decisions on surgical candidacy and patient counseling. Level of Evidence. II. [ABSTRACT FROM AUTHOR]

Background: The purpose of this study was to identify and describe common views of people with lived experience of mental health challenges – consumers and carers, families and supporters – of what they consider the most important measures to include in health economic evaluations which assess the incremental value of competing options in mental health care. Methods: Participants (n = 111) were people living in the state of Victoria, Australia, who identified as consumers of mental healthcare (n = 38); carers, family members and/or supporters (n = 43); or both (n = 30). Factor analysis based on Q-Methodology was used to identify clusters of people who hold similar viewpoints. Common viewpoints were described in terms of the characteristics of the group, and a qualitative interpretation was conducted on the basis of distinguishing statements and quotes provided in participants' own words. Results: We identified four common views: (1) safety before all else, prioritizing physical, sexual and psychological safety; (2) hope and partnership in processes of care; (3) physical and emotional health and wellbeing; and (4) care access, continuity and partnership with families. Although different priorities were identified for each viewpoint, key priority areas that were common to all views were having an environment in the health service that fosters respect and dignity, and that consumers feel heard and listened to. In sub-group and qualitative analyses, differences were observed regarding the likelihood of consumers and carers holding each of the views, as well as by age group. Conclusions: While some differences were noted between the views of consumers and carers and different age groups, there was also common ground regarding what outcomes are of most importance to measure. Including these measures in evaluation frameworks would provide a way of focussing mental healthcare decisions on the aspects of mental healthcare that are of most value to consumers and carers, thereby addressing an important shortcoming of current approaches to decision-making in mental healthcare. Highlights: We identified four common viewpoints of consumers and carers in terms of what they consider the most important measures to include in health economic evaluations which asses the incremental value of competing options in mental health care: (1) safety before all else, prioritizing physical, sexual and psychological safety; (2) hope and partnership in processes of care; (3) physical and emotional health and wellbeing; and (4) care access, continuity and partnership with families. Key priority areas that were common to all views were having an environment in the health service that fosters respect and dignity, and that consumers feel heard and listened to. After these, each view was characterized by a different level of priority on additional areas of health and wellbeing, as well as processes and characteristics of care. Including the priority measures from each view within evaluation frameworks would start to incorporate the values and priorities of consumers and carers into mental healthcare decision-making, thereby addressing an important gap in current decision-making processes. [ABSTRACT FROM AUTHOR]

Background: The European Organization of Research and Treatment of Cancer (EORTC) has recently developed and validated a patient-reported outcome measure (PROM) for sexual health (SH) in cancer patients. Here, we present results from a secondary analysis of the EORTC QLQ-SH22 validation study. The objective was to investigate the impact of cancer treatment on SH over the disease trajectory into survivorship in patients who underwent curative treatment. Methods: Participants completed the EORTC QLQ-SH22 and the EORTC QLQ-C30 assessing SH and Quality of Life. We analyzed differences in SH of patients on active cancer treatment compared to patients off-treatment (cross sectional group comparison) as well as changes in SH during the course of treatment (from pre-treatment to follow-up). Results: Our sample consisted of n = 394 (66.2% females) curatively treated cancer patients with 34% of patients being on-treatment and 66% of patients being in their follow-up after primary treatment (off-treatment group). Compared to patients off- treatment, patients on active cancer treatment experienced less sexual satisfaction (p =.021, Cohen's d =.36) and libido (p <.001, d =.60) and had higher levels of fatigue (p <.001, d =.50). Importance of sexual activity, masculinity and femininity did not differ between groups. Treatment effects on sexual activity decreased with treatment completion (p <.001, d =.50). Patients undergoing intensified treatment (chemotherapy, radiation, or endocrine treatment) reported more treatment effects (subscale EORTC QLQ-SH22) compared to patients undergoing surgery only. Conclusion: Our results highlight the negative impact of oncological treatment on SH and how increasing treatment intensity further impair SH. Sexual satisfaction and libido improve after treatment completion while other aspects (e.g. masculinity/femininity) do not change during survivorship. We suggest monitoring of SH from the start of cancer treatment on and beyond into survivorship using PROMs as part of routine cancer care. Routine monitoring allows systematic identification of patient's SH problems and may improve awareness as well as target intervention for those in need of care. [ABSTRACT FROM AUTHOR]

Background: Incorporating backfill cohorts in phase I oncology trials is a recently developed strategy for dose optimization. However, the efficacy assessment window is long in general, causing a lag in identifying ineffective doses and more patients being backfilled to those doses. There is necessity to investigate how to use patient-reported outcomes (PRO) to determine doses for backfill cohorts. Methods: We propose a unified Bayesian design framework, called 'Backfill-QoL', to utilize patient-reported quality of life (QoL) data into phase I oncology trials with backfill cohorts, including methods for trial monitoring, algorithm for dose-finding, and criteria for dose selection. Simulation studies and sensitivity analyses are conducted to evaluate the proposed Backfill-QoL design. Results: The simulation studies demonstrate that the Backfill-QoL design is more efficient than traditional dose-expansion strategy, and fewer patients would be allocated to doses with unacceptable QoL profiles. A user-friendly Windows desktop application is developed and freely available for implementing the proposed design. Conclusions: The Backfill-QoL design enables continuous monitoring of safety, efficacy and QoL outcomes, and the recommended phase II dose (RP2D) can be identified in a more patient-centered perspective. [ABSTRACT FROM AUTHOR]

AbstractObjectiveMethodsResultsConclusion\nPLAIN LANGUAGE SUMMARYTo evaluate quality of life, migraine disability, and work productivity and activity impairment in patients with migraine who received preventive treatment by comparing standard of care preventive medications and calcitonin gene-related monoclonal antibodies (CGRP mAbs), including galcanezumab alone.This cross-sectional study conducted across the United States (US) and Europe used data from the Adelphi Migraine Disease Specific Programme. Physicians completed record forms for consecutive patients, who then completed self-report forms assessing patient-reported outcomes (PROs) such as quality of life, migraine disability, and work productivity and activity impairment. T-tests, Fisher’s exact test, and Mann–Whitney U test were used for analysis.From May 2022 to June 2023, 557 physicians submitted data for 6723 patients. A total of 4036 patients (US 956; Europe 3080) with a history of preventive treatment were included (>60% female, >80% White, mean [standard deviation] age range, 38.7 [12.8] to 46.3 [12.1]). Patients who received 3+ lines of preventive therapy and were receiving CGRP mAbs (including galcanezumab alone) had enhanced health-related quality of life (HRQoL) compared to those who received standard of care. Similar findings were observed across Europe; however, in the US, there was no significant difference in any PROs.Patients with migraine in the overall population and Europe who received 3+ lines of preventive migraine therapy and were receiving CGRP mAbs/galcanezumab demonstrated enhanced HRQoL compared to those who received standard of care.This study evaluated quality of life, migraine disability, and work productivity in patients with migraine who were treated with standard of care preventive medications or calcitonin gene-related monoclonal antibodies (CGRP mAbs), including galcanezumab alone. The study was conducted across the United States and Europe and included data from 557 physicians and 6723 patients. Results showed that patients with migraine who received 3+ lines of preventive therapy and were receiving CGRP mAbs in overall population and Europe demonstrated enhanced health-related quality of life (HRQoL) compared with those who received standard of care. However, in the US, there was no significant difference in HRQoL and migraine disability. The study concludes that CGRP mAb treatments, especially in patients requiring multiple lines of preventive therapy, are a viable approach for optimal migraine management. [ABSTRACT FROM AUTHOR]

Aim Method Results Conclusion While modern treatment has improved rectal cancer (RC) survival, it can cause late side effects that impact health‐related quality of life (HRQoL). The aim of this study was to evaluate HRQoL and late effects 1 year after diagnosis in patients who underwent major resection for Stage I–III RC.All patients with RC registered in the Cancer Registry of Norway between 1 January 2019 and 31 December 2020, aged ≥ 18 years, and a control group without colorectal cancer were invited to participate in the study by answering a questionnaire on HRQoL and late effects. Functional domains and symptoms were compared in different patient groups and between patients and controls.There were 558 patients and 1693 controls eligible for analysis. Response rates were 41% for patients and 23% for controls. Some differences in HRQoL were observed between treatment modalities. Major low anterior resection syndrome (LARS) was prevalent in 60.8% of patients, and was associated with lower functional and higher symptom scores compared with patients with no/minor LARS. Patients with major chronic pain [n = 86 (15.4%)] had significantly lower scores for most of the functional items and higher symptom scores than patients with no/minor chronic pain. Patients had some lower functional scores and several higher symptoms score compared with controls.Patients who suffered from major LARS or major chronic pain had significantly impaired functions and more symptoms beyond change in bowel function and pain, respectively. Identification and treatment of these patient may hopefully be beneficial for their HRQoL. [ABSTRACT FROM AUTHOR]

The article discusses the need for a population-based clinical quality registry for pancreatic cancer surgery in Australia and Aotearoa New Zealand (AANZ). It highlights the importance of registries in improving patient outcomes through standardization of care, adherence to guidelines, and research facilitation. The text addresses three fallacies hindering the establishment of a pancreatic cancer surgery registry and emphasizes the cost-effectiveness and benefits of such a registry. It also compares existing registries in Australia to international benchmarks, advocating for the development of a robust binational pancreatic surgery registry in AANZ. [Extracted from the article]

Background: Focal cartilage lesions (FCLs) are frequently found during knee arthroscopies and may impair quality of life (QoL) significantly. Several treatment options with good short-term results are available, but the natural history without any treatment is largely unknown. The aim of this study was to evaluate patient-reported outcome measures (PROMs), the need for subsequent cartilage surgery, and the risk of treatment failure 20 years after diagnosis of an FCL in the knee. Methods: Patients undergoing any knee arthroscopy for an FCL between 1999 and 2012 in 6 major Norwegian hospitals were identified. Inclusion criteria were an arthroscopically classified FCL in the knee, patient age of ≥18 years at surgery, and any preoperative PROM. Exclusion criteria were lesions representing knee osteoarthritis or "kissing lesions" at surgery. Demographic data, later knee surgery, and PROMs were collected by questionnaire. Regression models were used to adjust for and evaluate the factors impacting the long-term PROMs and risk factors for treatment failure (defined as knee arthroplasty, osteotomy, or a Knee injury and Osteoarthritis Outcome Score-Quality of Life [KOOS QoL] subscore of <50). Results: Of the 553 eligible patients, 322 evaluated patients (328 knees) were included and analyzed. The mean follow-up was 19.1 years, and the mean age at index FCL surgery was 36.8 years (95% confidence interval [CI], 35.6 to 38.0 years). The patients without knee arthroplasty or osteotomy had significantly better mean PROMs (pain, Lysholm, and KOOS) at the time of final follow-up than preoperatively. At the time of follow-up, 17.7% of the knees had undergone subsequent cartilage surgery. Nearly 50% of the patients had treatment failure, and the main risk factors were a body mass index of ≥25 kg/m2 (odds ratio [OR] for overweight patients, 2.0 [95% CI, 1.1 to 3.6]), >1 FCL (OR, 1.9 [CI, 1.1 to 3.3]), a full-thickness lesion (OR, 2.5 [95% CI, 1.3 to 5.0]), and a lower level of education (OR, 1.8 [95% Cl, 1.1 to 2.8]). Autologous chondrocyte implantation (ACI) was associated with significantly higher KOOS QoL, by 17.5 (95% CI, 3.2 to 31.7) points, and a lower risk of treatment failure compared with no cartilage treatment, microfracture, or mosaicplasty. Conclusions: After a mean follow-up of 19 years, patients with an FCL who did not require a subsequent knee arthroplasty had significantly higher PROM scores than preoperatively. Nonsurgical treatment of FCLs had results equal to those of the surgical FCL treatments except for ACI, which was associated with a better KOOS and lower risk of treatment failure. Full-thickness lesions, >1 FCL, a lower level of education, and a greater BMI were the main risk factors associated with poorer results. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence. [ABSTRACT FROM AUTHOR]

Background: Migraine is a neurological condition marked by frequent headaches, which tends to be accompanied by nausea and vomiting in severe instances. Injectable therapies for migraine, such as monoclonal antibodies that target calcitonin gene-related peptide (CGRP), have proven to be effective and safe. While various oral drugs are available, none have been developed for migraines. Patients prefer oral therapies because they are easier to use, making atogepant, an orally accessible small-molecule CGRP receptor antagonist, a possible alternative. Objectives: This systematic review and meta-analysis compared the safety and effectiveness of atogepant with placebo in treating migraine. Methods: Adhering to the PRISMA guidelines, we meticulously gathered randomized controlled trials (RCTs) from databases including the Cochrane Library, PubMed, Science Direct, and ClinicalTrials.gov. Studies comparing atogepant with placebo and reporting monthly migraine days (MMDs) as the primary outcome along with secondary outcomes such as monthly headache days and acute medication use days were included. Two independent reviewers conducted the data extraction and quality assessment. Statistical analyses were carried out using RevMan, utilizing risk ratios for dichotomous outcomes and mean differences for continuous outcomes, and a random-effects model. Results: Our primary outcome was the change in MMDs over 12 weeks, which showed a significant reduction with atogepant at dosages of 10, 30, and 60 mg. Secondary outcomes, such as monthly headache days, proportion of patients achieving a ≥ 50% reduction in MMDs, acute medication use days, and patient-reported outcomes, consistently showed that atogepant outperformed placebo, highlighting its effectiveness in reducing the migraine burden. Conclusion: Higher doses of atogepant are more effective in lowering migraine and headache-related days and increasing quality of life metrics. However, this is accompanied by an increased incidence of adverse events, suggesting the need for careful dose optimization to balance the benefits and risks. Systematic review registration: https://www.crd.york.ac.uk/PROSPERO/display%5frecord.php?RecordID=563395. Unique Identifier: CRD42024563395. [ABSTRACT FROM AUTHOR]

Purpose Methods Results Conclusion Level of Evidence To determine whether there is a correlation between preoperative coronal varus or valgus laxity and patient‐reported outcome measures (PROMs) 2 years after individualised total knee arthroplasty (TKA).Records of 150 consecutive patients who received individualised TKA were retrospectively analysed, and 126 with complete pre‐ and postoperative data were included. Preoperative coronal varus and valgus stress radiographs (15 N load) were taken using a telos stress device with the knee in 5°–10° of flexion. Varus stress angles were positive if the joint opened on the lateral side, and valgus stress angles were positive if the joint opened on the medial side. The sum of varus and valgus stress angles indicated total joint laxity. During surgery, cases that required tibial recuts to balance the joint were recorded. Patients completed three PROMs and rated their satisfaction. Correlations between laxity and PROMs were evaluated using Pearson's correlation.Stress radiographs revealed varus stress angles of 6.3° ± 3.5° (range, −4.5° to 14.1°), valgus stress angles of 0.1° ± 3.7° (range, −8.0° to 10.9°), and the sum of the varus and valgus stress angle of 6.4° ± 3.3° (range, 0.1° to 17.1°). There were no correlations between laxity and PROMs: r < 0.160 for varus stress angle, r < 0.180 for valgus stress angle and r < 0.160 for the sum of stress angles. There were no statistically significant or clinically relevant differences in PROMs between knees without and those with tibial recuts.Preoperative coronal varus or valgus laxity was not correlated with PROMs following individualised TKA at a minimum 2‐year follow‐up. Individualised TKA with personalised alignment enables adequate accommodation of a broad spectrum of preoperative coronal varus–valgus laxities.IV [ABSTRACT FROM AUTHOR]

Objective: To evaluate the psychometric properties of a patient-reported outcome measure, the Automated Insulin Delivery—Benefits and Burdens Scale (AID-BBS), which was designed to assess benefits and burdens of AID use in adults with type 1 diabetes (T1D). The measure was hypothesized to have validity, reliability, and clinical utility for predicting likelihood of continued use of an AID system. Research Design and Methods: A total of 217 adults with T1D (ages from 18 to 82 years) who were enrolled in an AID system research trial completed AID-BBS items at study midpoint (6 weeks) and at the end of the trial (13 weeks). Data were collected on pre-post glycemic outcomes. Participants completed other patient-reported psychosocial outcome measures (e.g., emotional well-being, diabetes distress, attitudes toward diabetes technology, diabetes treatment satisfaction) at Week 13. Likelihood of continued device use was assessed with three items at 13 weeks. Results: Exploratory factor analysis supported a one-factor structure for each subscale (15-item benefit and 9-item burden subscale) when evaluated separately. Convergent, discriminant, and predictive validity, internal consistency, and test–retest reliability were supported. Benefit and burden subscales at week 6 predicted usage intention above and beyond device impact on glycemic outcomes, also controlling for baseline glycemic outcomes. Conclusion: Findings support the AID-BBS as a psychometrically valid, reliable, and useful instrument for assessing burdens and benefits associated with AID system use in adults with T1D. The measure can be used to help health care providers set realistic expectations and proactively address modifiable burdens. Clinical Trial Registration Number: NCT04200313. [ABSTRACT FROM AUTHOR]

Objective: The development of adjacent segment disease or the progression of spondylosis following the surgical treatment of spinal stenosis and spondylolisthesis is well documented and can lead to subsequent functional decline after a successful index surgery. The early detection of negative inflection points during patients' functional recovery can improve timely intervention. In this study, we developed machine learning (ML) models to predict the occurrence of post-operative decline in patient mobility. Methods: Patients receiving spine surgery for degenerative spinal stenosis or spondylolisthesis were retroactively consented and enrolled. Activity data (steps-per-day) previously recorded across a 4-year peri-operative were collected alongside relevant clinical and demographic variables. Logistic regression (LR), random forest (RF), and extreme gradient boosting (XGBoost) ML models were constructed and trained on 80% of the dataset and validated using the remaining 20%. The study's primary endpoint was the models' ability to predict post-operative decline in patient mobility. Results: A total of 75 patients were included. Following training, RF and XGBoost models achieved accuracy values of 86.7% (sensitivity 80%, specificity 90%) and 80% (sensitivity 60%, specificity 90%), respectively, in predicting post-operative functional decline. The LR model was the least effective with an accuracy of 73.3% (sensitivity 50%, specificity 88.8%). Receiver operating characteristic curves showed an area under the curve of 0.80 for RF, 0.70 for XGBoost, and 0.69 for LR. Conclusions: ML models trained on activity data collected from smartphones successfully forecast functional decline in post-operative activity following spine surgery. These results lay the groundwork for the future integration of ML into the surgeon's toolbox for prognostication and surgical planning. [ABSTRACT FROM AUTHOR]

Background/Objectives: The optimal graft, particularly in combined anterior cruciate ligament (ACL) and medial collateral ligament (MCL) injuries, remains controversial. We evaluated the influence of graft choice between bone-patellar tendon-bone (BPTB) and hamstring autografts on clinical outcomes in combined ACL and MCL injuries. Methods: This retrospective analysis included patients with concurrent ACL and MCL injuries who underwent single-bundle ACL reconstruction with BPTB (group B) or hamstring (group H) grafts, between 2010 and 2019, with a ≥2-year follow-up. Patients were classified based on the MCL injury grade (I, II, or III). Clinical outcomes were assessed through knee stability evaluations using valgus stress radiographs and the KT-2000 arthrometer, patient-reported outcomes using the International Knee Documentation Committee (IKDC) subjective score and Lysholm score, and radiologic outcomes using the IKDC radiographic grade. Results: The study included 169 patients (group B, 92; group H, 77). No significant between-group differences in knee stability or functional outcomes were found after follow-up. Within the same MCL injury grade, particularly in high-grade MCL injuries, BPTB grafts resulted in significantly better medial stability (side-to-side difference in medial joint opening on valgus stress radiographs: grade II, p = 0.006; grade III, p = 0.039) and functional outcomes (IKDC subjective score: grade II, p = 0.045; grade III, p = 0.038) than hamstring grafts. In the hamstring group, higher-grade MCL injuries were associated with worse outcomes (Lysholm knee score, p = 0.009; IKDC subjective score, p = 0.015). Conclusions: Graft choice in ACL reconstruction with concomitant MCL injuries may affect clinical outcomes, particularly in high-grade MCL injuries. Although both graft types performed similarly overall, BPTB grafts provided superior medial stability and functional results in higher-grade MCL injuries. However, caution is needed when interpreting these results due to limitations such as the small sample size and the lack of randomization in graft selection. [ABSTRACT FROM AUTHOR]

Purpose: Mapping or matching the items in a clinical outcome assessment (COA) to concepts that define a condition is a common method for evaluating a COA's concept coverage. The purpose of this research was to address the lack of formal guidance for conducting this task by developing a framework for best practices in COA concept mapping and applying it to a case study. Methods: To develop the framework, we examined the literature and created a draft set of best practices which was then reviewed by experienced researchers through focus groups before being finalized. To conduct the case study, we extracted data from a systematic review of knee osteoarthritis (KO) symptoms and impacts and used the framework to map relevant concepts to items in the SF-36v2® Health Survey (SF-36v2). Results: The framework guides researchers in defining the purpose of and data sources for the mapping, establishing guiding principles and decision-making thresholds, and conducting the mapping exercise. The results of the case study demonstrate the usefulness of the framework in identifying 27/36 items (75%) in the SF-36v2 that addressed concepts that define KO. Conclusion: This case study illustrates how the framework for best practices in COA concept mapping may be used, highlighting how establishing clear concept definitions and guiding principles and following a structured process throughout can help produce consistent, reliable, and reproducible results. The results from this rigorous approach can provide valuable evidence to support decisions about the appropriateness of a COA for the intended patient population. Plain English Summary: In health-related quality of life research, mapping items in a clinical outcome assessment (COA) to concepts that define a health condition is one way to evaluate an instrument's content validity (or, how well the instrument addresses the concepts it intends to measure). Without formal guidance on how to do this mapping, researchers can be inconsistent. This article describes the development of a framework for best practices in COA concept mapping. Informed by the literature and input from researchers with expertise in COA development and evaluation, the final framework guides researchers through the mapping process from start to finish, from helping to define the purpose of the task and identify the data sources, to establishing guiding principles and decision-making thresholds, conducting the mapping, and displaying the results. A case study—in which items from the SF-36v2® Health Survey were mapped to concepts from a systematic review of knee osteoarthritis symptoms and impacts—shows the framework in action, demonstrating how following the best practices can lead to consistent results that can support the evaluation of an instrument's content validity. [ABSTRACT FROM AUTHOR]

Purpose: Standardized patient-reported outcomes (PRO) monitoring during and after rectal cancer treatment provides insight into treatment-related toxicities patients experience and improves health-related quality-of-life as well as overall survival. We aimed to select a subset of the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for standardized monitoring of treatment-related symptomatic toxicities in rectal cancer. Methods: We used a mixed methods approach including a literature review, and semi-structured interviews with health care providers (HCPs) involved in rectal cancer care and rectal cancer patients. Results from literature and interviews were summarized and used in a modified Delphi procedure to select a PRO-CTCAE subset specific for rectal cancer. Results: Twenty-six PRO-CTCAE symptomatic toxicities were identified from literature. Fifteen HCPs from multiple disciplines (medical, radiation and surgical oncology), and a heterogeneous group of fifteen rectal cancer patients treated with chemotherapy and/or radiotherapy and/or surgery, participated in semi-structured interviews. Ten HCPs (67%) and nine patients (90%) participated in the first Delphi round. The final selected PRO-CTCAE core-subset contained 16 symptomatic toxicities: 'diarrhea', 'fecal incontinence', 'constipation','bloating of the abdomen', 'pain in the abdomen', 'vomiting', 'decreased libido', 'pain during vaginal sex', 'ability to achieve and maintain erection', 'fatigue', 'anxiety', 'feeling that nothing could cheer you up', 'urinary incontinence', 'painful urination', 'general pain', and 'hand-foot syndrome'. Conclusion: Based on a comprehensive mixed methods study, a PRO-CTCAE subset for standardized treatment-related symptomatic toxicity monitoring in rectal cancer was identified. Assessment of the effectiveness and compliance of symptomatic toxicity monitoring using this subset is recommended. [ABSTRACT FROM AUTHOR]

Purpose: Systematic reviews of patient-reported outcome measures (PROMs) are important tools to select the most suitable PROM for a study or clinical application. Conducting these reviews is challenging, and the quality of these reviews needs to be improved. We updated the COSMIN guideline for systematic reviews of PROMs, including the COSMIN Risk of Bias checklist, and the COSMIN criteria for good measurement properties. Methods: Adaptations to the methodology were based on our experience with applying the COSMIN guideline, through discussions among the authors, and results from two related Delphi studies. Results: The updated guideline places more emphasis on key aspects that are often missing or sub optimally conducted in published systematic reviews of PROMs, such as formulating a well-defined research question and developing a comprehensive search strategy, assessing risk of bias, applying criteria for good measurement properties, summarizing results, and grading the quality of the evidence. We also stress the importance of evaluating the measurement properties of each subscale of a PROM separately and evaluating content validity of all included PROMs. Conclusion: The quality of systematic reviews of PROMs can be improved by using this updated version of the COSMIN guideline for systematic reviews of PROMs. Improved quality will lead to better PROM selection and increased standardization of PROM use. Plain English summary: Patient-reported outcome measures (PROMs) are questionnaires that measure aspects of health from the patient perspective. To measure a specific health aspect, often dozens of PROMs are available. To choose the best PROM, a systematic review of PROMs can be conducted, in which all information on the quality and feasibility of each available PROM is collected, rated, and compared. Based on such a review a choice for the most suitable PROM for a certain study or clinical application can be made. However, conducting a systematic review of PROMs is very challenging, because nine quality aspects of PROMs need to be taken into account. In this article, we present an updated step-by-step guideline for conducting systematic reviews of PROMs. Each of these steps is described in detail in an accompanying manual. This updated guideline helps researchers to conduct systematic reviews of PROMs in a systematic and transparent way. It also helps readers of systematic reviews to understand how the review was conducted and to check the conclusions about which PROMs are recommended based on their quality. [ABSTRACT FROM AUTHOR]

Purpose: Brachial plexus birth injuries (BPBI) can have lifelong effects on the development and functional use of the upper extremity. Currently there is no agreement with regards to what patient-reported outcome (PRO) measures should be used. Therefore, the ability to compare the effects of treatment between individuals and institutions is challenging. This study aimed to achieve consensus among clinicians on the use of PRO measures within this patient group to allow for improved comparison of treatments and outcomes in the future. Materials and Methods: Online, a 3 round Delphi survey was completed by 35 international multi-disciplinary specialist centers. Results: All respondents (100%) agreed that PRO measures are useful for clinical evaluation and patient treatment. None of the outcome measures scored >75% agreement for ability to assess responsiveness and current state in children with BPBI as most outcome measures were judged as not specific for BPBI. Additionally, participant centers were asked their perspective on the best available PRO option for each of the 3 categories: functional use of the upper limb, quality of life and pain. This resulted in endorsement by the participant centers of the Brachial Plexus Outcome Measure – Self-Evaluation, the Pediatric Quality of Life Inventory, and Visual Analogue Scale/Brief Pain Inventory respectively. Conclusion: International specialists in BPBI agree that PRO measures are important to use both clinically and in research in children aged 5 years and above. IMPLICATIONS FOR REHABILITATION: Patient-reported outcome measures were judged as useful both in clinic and in research for brachial plexus birth injury (BPBI), according to a panel of specialized centers. Currently available outcome measures were judged as not specific for BPBI. The panel endorsed the following measures as best available: the Brachial Plexus Outcome Measure – Self-Evaluation scale for functional evaluation, the Pediatric Quality of Life Inventory for disease-related quality of life and the Faces Pain Scale - Revised/Visual Analogue Scale/Brief Pain Inventory for pain [ABSTRACT FROM AUTHOR]

AbstractObjectiveDesignSettingParticipantsResultsConclusionsTo explore the frequency of administration and the usage of the Hip Disability and Knee injury Osteoarthritis Outcome Scores (HOOS/KOOS) and their Physical function Short forms (HOOS-PS/KOOS-PS) by physiotherapists after total hip and knee arthroplasties (THA/TKA).A cross-sectional study using an open online survey.Primary care physiotherapy practices affiliated with the Dutch Association for Quality in Physiotherapy.Physiotherapists with experience treating over five patients with a THA or TKA within the past 5 years.One hundred and sixty-six physiotherapists completed the survey (median age: 40.0 years, female: 34%, median experience: 15.0 years). Of those, 32 did not administer the HOOS(-PS) or KOOS(-PS) (‘non-users’), 41 administered only due to organisational requirements or guideline recommendations (‘passive users’) and 93 actively used them for individual patient treatment purposes (‘active users’). ‘Treatment evaluation’, ‘diagnosis’, and ‘prognosis’ were most often reported as potential reasons to actively use the HOOS(-PS) or KOOS(-PS) for individual treatment purposes. Determinants associated with active use of the HOOS(-PS) or KOOS(-PS) appeared to be fewer years of experience as a physiotherapist, a larger treatment volume of THA/TKA, a younger age, and higher attitude scores regarding PROM use.Most responding physiotherapists administer the HOOS(-PS) or KOOS(-PS), but their use for individual treatment is limited. Active users appear to be less experienced, younger, treat larger volumes of THA/TKA, and possess a more positive attitude towards using patient-reported outcome measures. [ABSTRACT FROM AUTHOR]

The Oswestry disability index (ODI) is widely utilized as a patient reported outcome (PRO) tool to assess patients presenting with low back pain (LBP) and following thoracolumbar spine surgery. No primary study has calculated the baseline range of ODI values in the diverse American population. Establishing age-adjusted normative values for ODI in the American population is crucial for assessing the utility of treatment strategies. The purpose of this study is to describe the baseline range of functional low back disability as measured by the ODI in an American population. Cross-sectional observational study. A total of 1214 participants were recruited from the United States in January 2024 using a combination of the Connect and PrimePanel platforms by CloudResearch to complete a survey administered on a RedCap online database. The survey consisted of 10 demographic questions and the 10 ODI survey questions. The distribution of the survey was designed to obtain approximately 100 respondents in each of the following age groups: 18–29, 30 to 39, 40 to 49, 50 to 59, 60 to 69, 70 to 79, and 80 to 89. The distribution of the sample was similarly designed to match the United States Census racial data with 78.1% White, 13.9% Black, and 7.9% other. Oswestry disability index (ODI). A crowd-sourcing platform called Cloudresearch was used to collect a representative sample of the US population by answering questions of the Oswestry disability questionnaire (ODQ), a 10-question survey. The final sample size was 797 participants including 386 (48.4%) males and 411 (51.6%) females; 169 participants were excluded that did not complete the survey and an additional 248 were excluded for failing attention check questions. The overall mean ODI score for the combined age groups was 14.35 (95% CI [13.33, 15.37]). The mean ODI scores increased with age, with the highest mean ODI in ages 70 to 79 at 18.0 (95% CI [14.76, 21.24]). Female participants reported higher mean ODI scores than their male counterparts in the 18 to 29 age group (p=.01), 50 to 59 age group (p=.01), and 60 to 69 age group (p=.02). Additionally, a weak positive correlation was found between Body Mass Index (BMI) and ODI scores (r = 0.22, p<.001). Our findings demonstrate a clear trend of increased disability with age. This study describes the baseline range of functional low back pain disability in the United States population. By defining these parameters, healthcare professionals can better tailor age and sex-specific interventions to manage disability in the aging US population, ultimately improving patient care and both operative and nonoperative treatment plans for LBP-related thoracolumbar pathology. [ABSTRACT FROM AUTHOR]

Purpose: This study aimed to conduct a comparative analysis of audiological and postoperative clinical outcomes between the endoscopic and microscopic stapedotomy approaches. Methods: This study employed a randomized, controlled design. Twenty-seven patients with bilateral otosclerosis underwent stapedotomy in both ears, with randomized allocation of the surgical technique (endoscopic vs. microscopic) for the first operated ear. Air-bone gap (ABG) and ABG gain were measured at least 12 months postoperatively. Postoperative outcomes including pain (Visual Analog Scale-VAS), dizziness, early-term (day 1) and late-term (6 months) dysgeusia were evaluated. The Glasgow Benefit Inventory (GBI) assessed health-related quality of life at one month postoperatively, and operative time was measured. Results: This study compared endoscopic (n = 27 ears) and microscopic (n = 27 ears) stapedotomy for otosclerosis. Both groups achieved similar hearing improvement with no significant differences in pre-operative and post-operative bone/air conduction thresholds, ABG, and ABG gain (all p > 0.05). The endoscopic stapedotomy group demonstrated reduced postoperative pain (lower VAS scores, p < 0.001), lower early dysgeusia (3.7% vs. 33.3%, p = 0.005), shorter operative time (47.3 vs. 75.4 min, p < 0.001) and improved patient-reported outcomes (higher GBI score, p = 0.014) when compared to microscopic stapedotomy group. No significant differences were observed in postoperative dizziness or late-term dysgeusia between groups. Conclusion: This study found similar hearing improvement with both endoscopic and microscopic stapedotomy for otosclerosis. However, the endoscopic approach showed advantages in reduced postoperative pain, early dysgeusia, and operative time, with improved patient-reported quality of life. These findings suggest endoscopic stapedotomy as a valuable alternative to the conventional microscopic approach. [ABSTRACT FROM AUTHOR]

Background: Service delivery of post-treatment surveillance in head and neck cancer (HNC) varies across institutions in Australia. To better understand current practices and develop protocols that maximize service capacity or incorporate emerging technologies, especially in under-resourced regional and remote communities, it is important to obtain the perspectives of clinicians that regularly manage patients with HNC. Design: This cross-sectional study utilized an online survey distributed via email to specialists recruited from HNC-associated networks across Australia. The survey captured information on current practices and explored clinician perspectives towards re-designing the current surveillance model to incorporate telehealth or patient-reported outcome measures (PROMs). Quantitative data was analyzed using descriptive statistics while open-ended survey comments were analyzed using a content analysis approach. Results: Forty participants completed the survey (25 surgeons, 9 medical oncologists, 5 radiation oncologists and 1 oral medicine specialist). Most clinicians used either institution-specific guidelines (44%) or National Comprehensive Cancer Network guidelines (39%), with the remaining 17% using surveillance intervals based on patient symptoms. Following treatment, 53% of participants imaged patients only when there was clinical suspicion of recurrence or new symptoms. Planned surveillance imaging was conducted at 6 or 12-monthly intervals based on the HNC subtype. Fifty-seven percent of clinicians were open to redesigning the surveillance model, specifically in low-risk patients who did not require nasoendoscopic examination. Seventy-one percent had concerns regarding the feasibility of telehealth appointments, citing disparities in digital health equity. Additionally, 61% felt PROMs are currently underutilized and were open to incorporating HNC-specific PROMS into surveillance. Open-ended responses indicated that within the current surveillance model, "fragmented service provision" and "administration issues" were significantly impacting on timing of care. Conclusion: Surveyed HNC clinicians feel that current post-treatment surveillance can be fragmented and potentially lead to delayed care. They are open to incorporating PROMS to assist in surveillance scheduling, especially in low-risk patients. [ABSTRACT FROM AUTHOR]

Objective: The Return of Answer ALS Results (RoAR) Study was designed to provide a mechanism for participants in Answer ALS, a large, prospectively designed natural history and biorepository study to receive select clinical genetic testing results and study participants' experience with the results disclosure. Methods: Participants consented to receive results of five ALS genes (C9orf72, SOD1, FUS, TARDP, TBK1) and/or 59 medically actionable genes as designated by the American College of Medical Genetics. Patient-reported genetic testing outcomes were measured via a post-disclosure survey. Results: Of 645 eligible Answer ALS enrollees, 143 (22%) enrolled and completed participation in RoAR. Pathogenic variants were identified in 22/143 (15.4%) participants, including 13/143 (9.0%) in ALS genes and 9/143 (6.3%) in ACMG genes. Participant-reported measures of result utility indicated the research result disclosure was as or more successful than published patient-reported outcomes of result disclosure the clinical setting. Conclusions: This study serves as a model of a "disclosure study" to share results from genomic research with participants who were not initially offered the option to receive results, and our findings can inform the design of future, large scale genomic projects to empower research participants to access their genetic information. [ABSTRACT FROM AUTHOR]

Endometriosis, a common cause for chronic pelvic pain, significantly affects quality of life, fertility, and overall productivity of those affected. Therapeutic options remain limited, and collating evidence on treatment efficacy is complicated. One reason could be the heterogeneity of assessed outcomes in nonsurgical clinical trials, impeding meaningful result comparisons. This systematic literature review examines outcome domains and patient-reported outcome measures (PROMs) used in clinical trials. Through comprehensive search of Embase, MEDLINE, and CENTRAL up until July 2022, we screened 1286 records, of which 191 were included in our analyses. Methodological quality (GRADE criteria), information about publication, patient population, and intervention were assessed, and domains as well as PROMs were extracted and analyzed. In accordance with IMMPACT domain framework, the domain pain was assessed in almost all studies (98.4%), followed by adverse events (73.8%). By contrast, assessment of physical functioning (29.8%), improvement and satisfaction (14.1%), and emotional functioning (6.8%) occurred less frequently. Studies of a better methodological quality tended to use more different domains. Nevertheless, combinations of more than 2 domains were rare, failing to comprehensively capture the bio–psycho–social aspects of endometriosis-associated pain. The PROMs used showed an even broader heterogeneity across all studies. Our findings underscore the large heterogeneity of assessed domains and PROMs in clinical pain-related endometriosis trials. This highlights the urgent need for a standardized approach to both, assessed domains and high-quality PROMs ideally realized through development and implementation of a core outcome set, encompassing the most pivotal domains and PROMs for both, stakeholders and patients. [ABSTRACT FROM AUTHOR]

Purpose: Systemic Lupus Erythematosus (SLE) significantly affects both the quality of life related to health and non-health aspects. This study aims to evaluate the psychometric properties of the Persian version of the Lupus_PRO questionnaire, version 1.7. The questionnaire serves as a specific self-report outcome scale for assessing the treatment outcomes of Lupus disease. Methods: The Lupus_PRO questionnaire, version 1.7, was translated into Persian using the standard forward-backward method. After being completed by 218 patients with Lupus, the psychometric properties of the instrument were examined. The Convergent and Discriminant Validity of the scale were assessed using Average Variance Extracted and Cross Loadings, respectively. The construct validity of the questionnaire was also evaluated through Confirmatory Factor Analysis (CFA). Cronbach's alpha was calculated to assess the reliability of the questionnaire dimensions. Findings: Out of the 218 patients with lupus who participated in the current study, 13 (6%) were male, and 205 (94%) were female. The mean (SD) age of participants was 40.29 (10.94) years. The Average Variance Extracted (AVE) for HRQOL and Non-HRQOL constructs, except for the Coping and Cognition dimension, was greater than 0.50, indicating satisfactory convergent validity. The interdimensional correlation coefficient (Discriminant Validity) for each dimension with other questionnaire dimensions was less than 0.10, indicating that the questionnaire has good convergent and discriminant validity. Additionally, the results of the Confirmatory Factor Analysis (CFA) indicated that the questionnaire was a suitable fit. In terms of reliability, Cronbach's alpha for the various questionnaire dimensions ranged from 0.51 to 0.91, indicating good internal consistency. Conclusion: The Persian version of the Lupus_PRO questionnaire, version 1.7, demonstrates acceptable validity and reliability in the Iranian population. This instrument can effectively measure various aspects of the quality of life in patients with lupus. [ABSTRACT FROM AUTHOR]

Background Numerous studies have shown that obesity is a risk factor for postoperative complications following breast reconstruction. Hence, obesity has traditionally been considered a relative contraindication to microsurgical breast reconstruction. In this study, we investigated the impact of obesity on outcomes following microsurgical breast reconstruction. Methods A retrospective analysis of 200 consecutive patients who underwent microsurgical breast reconstruction with free abdominal flaps was performed. Subjects were divided into Nonobese (body mass index [BMI] < 30 kg/m 2) and Obese (BMI ≥ 30 kg/m 2) cohorts. Univariate and multivariate analyses were performed to evaluate differences in patient characteristics, complication rates, and efficiency metrics between the two groups. Results Of the 200 subjects included in the study, 128 were Nonobese, 72 were Obese. The prevalence of diabetes (3.9 vs. 16.9%, p = 0.002) and hypertension (14.7 vs. 39.4%, p < 0.001) were significantly greater in the Obese cohort. Among unilateral reconstructions, postoperative length of stay (LOS) was longer among Obese patients (3.1 vs. 3.6 days, p = 0.016). Seroma occurred more frequently in Obese patients following bilateral reconstruction (5.7 vs. 0.0%, p = 0.047). Otherwise, there were no significant differences in complication rates between the groups. On multivariate analysis, BMI was not independently associated with complications, LOS, or operative time. Conclusion The improvements in clinical and patient-reported outcomes that have been associated with postmastectomy breast reconstruction do not exclude obese women. This study indicates that microsurgical breast reconstruction can be performed safely and efficiently in patients with obesity. [ABSTRACT FROM AUTHOR]

Background Muscles affected by postparetic synkinesis have imbalanced tonicity that limit perioral mimetic movement and inhibit the ability to smile. The depressor anguli oris (DAO) muscle has been a common myectomy target for the treatment of perioral synkinesis. While addition of buccinator myectomies to DAO myectomies has risen, no studies have analyzed the effects of buccinator myectomies. The goal of this study was to evaluate and compare the effects of a DAO myectomy with and without concomitant buccinator myectomy through objective facial metrics and subjective patient-reported outcomes. Methods This study is a retrospective review of patients with postparetic synkinesis who underwent DAO myectomy (DAO myectomy group) or DAO myectomy with buccinator myectomy (DAO + Buccinator myectomies group). Outcomes included postoperative differences in objective smile measures (smile angle, excursion, and dental show) using validated software and patient-reported outcomes using the Facial Disability Index (FDI) questionnaire and a myectomy-specific questionnaire. Results After chart review, 18 patients were included in the DAO myectomy group and 19 in the DAO + Buccinator myectomies group. There were no significant postoperative differences between the groups in (1) smile excursion, angle, or dental show at resting, closed smile, or open smile (p > 0.05), (2) FDI physical and social scores, p = 0.198 and 0.932, respectively, or (3) myectomy-specific questionnaire responses (p > 0.05). Conclusion The addition of a buccinator myectomy to a DAO myectomy does not provide significant clinical benefit when compared with an isolated DAO myectomy, based on objective measures and subjective patient-reported outcomes. [ABSTRACT FROM AUTHOR]

Aim: To characterize and stratify health‐related quality of life in individuals with type 1 diabetes (T1D) using body mass index (BMI) and clustering analysis. Material and Methods: Baseline data on individuals with T1D were pooled from two studies. A post hoc analysis of health‐related quality of life, measured using the 36‐item Short‐Form questionnaire, was performed, referenced to the 2010 US general population. Descriptive statistics were presented for the pooled cohort and per BMI category. K‐means clustering was performed. One‐way analysis of variance was conducted to examine differences in clinical characteristics between clusters. Results: The pooled cohort consisted of 2256 individuals with T1D (age: 45.4 ± 15.0 years, BMI: 26.2 ± 4.6 kg/m2, diabetes duration: 22.7 ± 13.5 years). All quality‐of‐life domains were slightly lower than 50(the general population's mean), except for vitality. Individuals with a BMI ≥30 kg/m2 reported lower scores for bodily pain, physical functioning, general health, and vitality. A first cluster with a high and a second cluster with a low quality of life were identified, with significant differences in the mental (Cluster 1: 53.8 ± 6.8 vs. Cluster 2: 39.5 ± 10.7; p < 0.001) and physical component summary scores (Cluster 1: 49.6 ± 6.3 vs. Cluster 2: 35.2 ± 12.0; p < 0.001), which exceeded differences found between BMI categories. Conclusions: In our population of people living with T1D, higher BMI may have adversely impacted physical domains of quality of life, but larger differences between the high‐ and low‐quality‐of‐life cluster indicate that more factors play a role. [ABSTRACT FROM AUTHOR]

Study Design: Multicenter prospective study. Objective: Patients with central sensitization (CS) are reported to be at high risk of poor outcomes after spinal surgery. However, the influence of CS on surgical outcomes for lumbar disc herniation (LDH) remains unknown. This study aimed to examine the association between preoperative CS and surgical outcomes in LDH patients. Methods: A total of 100 consecutive patients with LDH (mean age 51.2) who underwent lumbar surgery were included in this study. The extent of CS was evaluated using the central sensitization inventory (CSI), a screening tool for CS-related symptoms. The patients completed the following CSI and clinical outcome assessments (COAs) preoperatively and 12 months postoperatively: the Japanese Orthopaedic Association (JOA) score for back pain, JOA back pain evaluation questionnaire (JOABPEQ), and Oswestry Disability Index (ODI). The association between preoperative CSI scores, and preoperative and postoperative COAs was analyzed, and the postoperative changes were statistically evaluated. Results: The preoperative CSI score significantly decreased 12 months postoperatively. Preoperative CSI scores showed a significant correlation with most COAs; however, a significant correlation was only identified in the social function and mental health domains of JOABPEC postoperatively. Higher preoperative CSI showed worse preoperative COAs; however, all COAs significantly improved regardless of CSI severity. There were no significant differences in any COAs among the CSI severity groups 12 months postoperatively. Conclusions: The results of this study showed that lumbar surgeries significantly improved the COAs regardless of preoperative severity of CS in patients with LDH. [ABSTRACT FROM AUTHOR]

Study Design: Prospective, multicenter, international, observational study Objective: Identify independent prognostic factors associated with achieving the minimal clinically important difference (MCID) in patient reported outcome measures (PROMs) among adult spinal deformity (ASD) patients ≥60 years of age undergoing primary reconstructive surgery. Methods: Patients ≥60 years undergoing primary spinal deformity surgery having ≥5 levels fused were recruited for this study. Three approaches were used to assess MCID: (1) absolute change:0.5 point increase in the SRS-22r sub-total score/0.18 point increase in the EQ-5D index; (2) relative change: 15% increase in the SRS-22r sub-total/EQ-5D index; (3) relative change with a cut-off in the outcome at baseline: similar to the relative change with an imposed baseline score of ≤3.2/0.7 for the SRS-22r/EQ-5D, respectively. Results: 171 patients completed the SRS-22r and 170 patients completed the EQ-5D at baseline and at 2 years postoperative. Patients who reached MCID in the SRS-22r self-reported more pain and worse health at baseline in both approaches (1) and (2). Lower baseline PROMs ((1) – OR:.01 [.00-.12]; (2)- OR:.00 [.00-.07]) and number of severe adverse events (AEs) ((1) – OR:.48 [.28-.82]; (2)- OR:.39 [.23-.69]) were the only identified risk factors. Patients who reached MCID in the EQ-5D demonstrated similar characteristics regarding pain and health at baseline as the SRS-22r using approaches (1) and (2). Higher baseline ODI ((1) – OR: 1.05 [1.02-1.07]) and number of severe AEs (OR:.58 [.38-.89]) were identified as predictive variables. Patients who reached MCID in the SRS22r experienced worse health at baseline using approach (3). The number of AEs (OR:.44 [.25-.77]) and baseline PROMs (OR:.01 [.00-.22] were the only identified predictive factors. Patients who reached MCID in the EQ-5D experienced less AEs and a lower number of actions taken due to the occurrence of AEs using approach (3). The number of actions taken due to AEs (OR:.50 [.35-.73]) was found to be the only predictive variable factor. No surgical, clinical, or radiographic variables were identified as risk factors using either of the aforementioned approaches. Conclusion: In this large multicenter prospective cohort of elderly patients undergoing primary reconstructive surgery for ASD, baseline health status, AEs, and severity of AEs were predictive of reaching MCID. No clinical, radiological, or surgical parameters were identified as factors that can be prognostic for reaching MCID. [ABSTRACT FROM AUTHOR]

Importance: Many women report inadequate symptom control after sacral neuromodulation (SNM), despite 50% reduction in urgency incontinence episodes (UUIE) after test stimulation. Objective: To determine the ideal percent UUIE reduction after test stimulation that predicts 24‐month success. Study Design: Using data from a multicenter SNM trial, we constructed receiver operating characteristic curves to identify an ideal threshold of percent UUIE reduction after test stimulation. We defined 24‐month success as Patient Global Impression of Improvement of "very much better" to "better." We compared predictive accuracy of two models predicting success: (1) percent UUIE reduction alone and (2) with baseline characteristics. Results: Of 149 women (median [IQR] baseline daily UUIE 4.7 [3.7, 6.0]), the ideal threshold for 24‐month success was 72% (95% confidence interval 64,76%) UUIE reduction with accuracy 0.54 (0.42, 0.66), sensitivity 0.71 (0.56, 0.86) and specificity 0.27 (0.05, 0.55). The accuracy of the 50% reduction threshold was 0.60 (0.49, 0.71), sensitivity 0.95 (0.88, 1.0) and specificity 0.04 (0.0, 0.12). Percent reduction in UUIE was not better than chance in predicting 24‐month success (concordance index [c‐index] 0.47 [0.46, 0.62]); adding age, body mass index, diabetes mellitus and visual or hearing impairment the c‐index was 0.68 (0.61, 0.78). Conclusions: Among women who received an internal pulse generator (IPG) due to ≥50% UUIE reduction after test stimulation, we found no ideal threshold that better predicted 24‐month success. Percent reduction in UUIE after test stimulation poorly predicts 24‐month success with or without clinical factors. Given this, re‐evaluating how we determine who should receive an IPG is needed. [ABSTRACT FROM AUTHOR]

Aim: To determine outcome measurement when odontogenic sinusitis (ODS) is treated by Endoscopic Sinus Surgery (ESS). Materials and Methods: A PRISMA compliant systematic review using MeSH headings on Pubmed, Ovid and Embase. Inclusion criteria: Adults with odontogenic maxillary sinus disease undergoing ESS. Exclusion criteria: Adolescents, odontogenic disease related to; trauma, neoplasia, tumour resection, palatal cleft or fungal infection, previous sinus surgery, endoscopic surgery not involving the middle meatus. Results: A total of 1462 papers were identified, 68 eligible for review. No randomised controlled trials were identified. Twenty‐three papers (34%) reported a successful outcome as no disease at endoscopy and reduced sinonasal symptoms; 14 papers (21%) based outcomes on endoscopy, reduced symptoms and resolution of sinus opacification or reduced mucosal thickness; 1 paper established success on reduced symptoms only and 7 papers (10%) based outcomes on radiographic findings only. Other primary measures of success were excision and closure of oro‐antral fistula, 6 (9%), removal of odontogenic cysts, 5 (7%), removal of displaced dental implants, 4 (6%), removal of displaced root of tooth, 3 (4%). Five papers (7%) reported no outcome measure. Additional measures of outcome were; retention of dental implants perforating the sinus floor, survival of sinus floor grafting with subsequent implant placement and retention of teeth with persistent apical periodontitis. Conclusion: Reported outcome measures were very heterogeneous. In consideration of the weak evidence base for the role of ESS in ODS management, more consistent measurement and reporting of patient symptoms, clinical and radiological signs with endoscopic findings is recommended to enable meta‐analysis. [ABSTRACT FROM AUTHOR]