Search

Uniportal video-assisted thoracoscopic surgery (U-VATS) can achieve traditional clinical outcomes comparable to those of multiportal video-assisted thoracoscopic surgery (M-VATS). This study aimed to compare patient-reported outcomes between U-VATS and M-VATS for lung cancer lobectomy in the early postoperative period.This comparative analysis used data from a longitudinal prospective study (Perioperative Symptom Study of Lung Cancer [CN-PRO-Lung 1]). Symptom severity, functional status, and quality of life were compared between groups using generalized estimation equation models. Symptom severity and functional status were reported as proportion of patients with clinically meaningful severe scores on 0- to 10-point scales assessed using the MD Anderson Symptom Inventory-Lung Cancer module.Of the 174 patients included, 102 (58.6%) underwent U-VATS lobectomy and 72 (41.4%) underwent M-VATS lobectomy. After adjusting for confounders, patients in the U-VATS group reported less severe pain (P = .02), fatigue (P = .001), constipation (P = .01), coughing (P = .003), shortness of breath (P.001), and disturbed sleep (P = .007) during the 6-day postoperative hospitalization than did patients in the M-VATS group. Moreover, fewer patients reported severe impairment in walking (P = .033) or their capacity to enjoy life (P = .027) in the U-VATS group. Meanwhile, there were no significant between-group differences in the quality of life scores, operative time, chest tube duration, length of hospital stay, or early complication rate (grade II or higher) (all P.05).U-VATS may produce fewer severe symptoms and better functional status than M-VATS for lung cancer lobectomy in the early postoperative period.

Background:The Utrecht Scale for Evaluation of Rehabilitation-Participation Restrictions scale (USER-P-R) is a promising patient-reported outcome measure, but has currently not been validated in a hospital-based stroke population. Objective:To examine psychometric properties of the USER-P-R in a hospital-based stroke population 3 months after stroke onset. Methods:Cross-sectional study including 359 individuals with stroke recruited through 6 Dutch hospitals. The USER-P-R, EuroQol 5-dimensional 5-level questionnaire (EQ-5D-5 L), Patient Reported Outcomes Measurement Information System 10-Question Global Health Short Form (PROMIS-10), modified Rankin Scale (mRS) and two items on perceived decrease in health and activities post-stroke were administered in a telephone interview 3 months after stroke. The internal consistency, distribution, floor/ceiling effects, convergent validity and discriminant ability of the USER-P-R were calculated. Results:Of all participants, 96.9% were living at home and 50.9% experienced no or minimal disabilities (mRS 0-1). The USER-P-R showed high internal consistency (alpha = 0.90) and a non-normal left-skewed distribution with a ceiling effect (21.4% maximum scores). A substantial proportion of participants with minimal disabilities (mRS 1) experienced restrictions on USER-P-R items (range 11.9-48.5%). The USER-P-R correlated strongly with the EQ-5D-5 L, PROMIS-10 and mRS. The USER-P-R showed excellent discriminant ability in more severely affected individuals with stroke, whereas its discriminant ability in less affected individuals was moderate. Conclusions:The USER-P-R shows good measurement properties and provides additional patient-reported information, proving its usefulness as an instrument to evaluate participation after 3 months in a hospital-based stroke population.

Background Retrospective auditing identified the need to implement a client centered tool to measure occupational performance and re engagement in activities after burn injury. The Canadian Occupational Performance Measure (COPM) was chosen as it has a broad focus on occupational performance across the lifespan. However, given the time constraints that acute care clinicians work within in a tertiary teaching hospital, a feasibility study was warranted to identify the time to complete the COPM and any potential barriers which may arise in order to evaluate the appropriateness of using this tool. Methods This project was a prospective cohort study. All patients presenting to the ward and the Specialist Burns Outpatient Clinic were consecutively enrolled in this study. Information was collected regarding administration of the COPM including administration time, number of interruptions and reasons for non-completion of the outcome measure e.g. wound dressing procedures, surgery, scheduling conflicts. A survey method was used to explore the perceptions of Occupational Therapy clinicians regarding use of the COPM in clinical practice. Results Over the course of the study period 70 COPM’s were administered. The average time for administration across both settings was 9 min. Individually the average time taken for administration of the COPM with inpatients was 11.21 min, in the outpatient setting 7.85 min. The Survey Monkey questionnaire was emailed to 58 occupational therapy clinicians working at the facility associated with the study. The response rate was 41.4% (24). Discussion Patient reported outcome measures are central to patient centred care which is a core element of health care provision. Results from this study found that the COPM took approximately 9 min to administer, which is suitable within the time constraints of an acute tertiary environment and would be feasible in our setting. Fifty one percent of the participants identified return to work as the activity of daily living most impacted by their burn injury. As burn injuries impact all domains of daily life the use of patient reported outcome measures to direct goal orientated care is imperative. Conclusion This study found that the time to administer the COPM is feasible within the acute tertiary setting. Perceived barriers identified can be overcome with increased knowledge of client centred practice and the importance of goal directed care. The use of patient reported outcome measures in clinical practice empowers consumers to identify what goals they would like to achieve.

Patients treated with palliative radiotherapy may experience symptoms decreasing their quality of life. Electronic patient-reported outcome measures (ePROMs) could provide an opportunity to follow-up patients after treatment.A mixed-method study was performed using self-constructed questionnaires, focus groups and interviews with patients and health care professionals (HCP). A qualitative approach was used to code the data.Forty-two patients, 21 radiation-oncologists, 15 general practitioners (GPs) and 24 home-care nurses completed a questionnaire. Ten patients, 6 radiation-oncologists, 14 GPs and 5 nurses were interviewed or participated in a focus group. Although patients and HCP are satisfied with current care, they believe ePROMs could improve follow-up, communication, continuity of care and self-management of symptoms. An easy to use, versatile ePROM platform seems to be important for successful implementation. Self-care tips and contact information should be added to relevant ePROM-questions, on both physical and psychological symptoms.Patients and HCP agree that ePROMs could improve systematical clinical follow-up after palliative radiotherapy, with self-management support being the primary objective of such a system. Practice implications ePROMs after palliative radiotherapy seem feasible, the exact patient population that could benefit the most will need to be explored further; as the palliative population is very diverse.

Objectives We investigated whether work participation is affected in patients with arthralgia during transition to RA. Arthralgia patients with symptom resolution and early RA patients at diagnosis were used as a reference. Methods Three groups of patients were studied: arthralgia patients converting to RA (n = 114), arthralgia patients with spontaneous symptom resolution (n = 57), and early RA patients (n = 617). Both presenteeism (i.e. working while sick, scale 0–10) and absenteeism (i.e. sick leave) were taken into account. Work ability 1 year prior to clinical arthritis was estimated (in absolute numbers). The course of work restriction over time was studied using linear mixed models (β coefficient; delta per month) within each patient group. Results One-year prior to the development of clinical arthritis, mean presenteeism was 7.0 (95% CI 5.8, 8.1) in patients with arthralgia, indicating 30% loss, and further worsened to 6.1 (95% CI 5.3, 6.6) at RA diagnosis, thus indicating 39% loss. In early RA patients, presenteeism improved over time after DMARD initiation (β 0.052 per month 95% CI 0.042, 0.061, P Conclusion In the months preceding RA, presenteeism was already apparent, and it worsened further during progression to clinical arthritis and diagnosis. This underlines the relevance of the symptomatic pre-RA phase for patients. The observed reversibility in arthralgia patients with symptom resolution may suggest that intervention in pre-RA could improve work participation.

Evaluating outcome in osteoarthritis (OA) clinical research and practice requires reliable, valid and responsive patient-reported outcome measures (PROMs) and functional tests that reflect important problems experienced by people with OA. The goal of this work is to provide information to start to guide the reader in selecting measures for people with OA. In this narrative review, we begin by providing an overview of measurement properties that can help clinicians and researchers in making decisions about whether a measure might be appropriate for use in their research or clinical context. We then report evidence supporting the use of measures of pain (e.g., Pain Visual Analogue (VAS), Numeric Pain Rating Scale (NPRS), Intermittent and Constant Osteoarthritis Pain, PROMIS Pain Interference, and, for screening in research, the painDETECT and the Self-report Leeds Assessment of Neuropathic Symptoms and Signs) and fatigue (e.g., PROMIS-Fatigue) at a group level in clinical research. Several multi-dimensional joint-specific measures (e.g., Western Ontario McMaster Universities' Osteoarthritis Outcomes Scale, Knee/Hip Injury and Osteoarthritis Outcome Score, Oxford Hip/Knee Scale) also have evidence for group-level use. Functional tests (e.g., timed walk tests, 30 Second Chair Stand, Timed Up and Go, etc.) have measurement properties supporting their use at the group level in clinical research and at the individual patient level as do the pain VAS and NPRS. Other generic and disease-specific PROMs have been used in or could be used in OA studies but their measurement properties require further evaluation in people with OA.

Clinician-reported outcome measures (ClinRO measures) play a fundamental role in quality assurance throughout healthcare systems. With commissioners turning ever more frequently to ClinRO data to evaluate and compare individual hospital performance and casemix, and funding decisions increasingly relying on these data, agreed core outcome sets (COS) are essential for the collection of standardised specialty-specific outcomes. Beyond their role in service commissioning, COS enable standardisation of outcomes in clinical studies, allowing comparisons to be drawn between similar trials as well as pooling of data for systematic reviews and metaanalyses. This review explores those ClinRO measures most commonly reported in the third molar literature, highlighting inconsistencies in ClinRO selection, measurement and reporting among researchers. We recognise here a prime opportunity for the specialty to address this lag in COS relative to other surgical specialties. With the Quality Outcomes in Maxillofacial Surgery (QOMS) overseeing the institution of many subspecialty-specific national databases in recent years, OMFS is well placed to develop a series of COS for each subspecialty domain for the benefit of researchers, clinicians and ultimately, patients.

Background: Patient-reported allergies (PRAs) are associated with suboptimal orthopaedic surgery outcomes and may serve as a proxy for mental health. While mental health disorders are known risk factors for increased opioid use, less is known about how PRAs impact opioid use after orthopedic surgery. The purpose of this study was to investigate the association between PRAs and postoperative opioid use, pain, and satisfaction following hand surgery. Methods: Patients who underwent ambulatory hand surgery at a single institution from May 2017 to March 2019 were retrospectively reviewed. Various scores, including the Mindfulness Attention Awareness Scale (MAAS), were collected preoperatively. Postoperatively, patients completed a 2-week pain diary, satisfaction, and visual analog scale (VAS) pain scores. Opioid consumption was converted to oral morphine equivalents (OMEs) using standard conversions. Results: A total of 137 patients were divided into 2 groups based on presence (≥1) (n = 73) or absence (0) (n = 64) of PRAs. At baseline, the ≥ 1 PRA group had significantly higher female composition ( P < .001) and pain ( P < .001) and lower PROMIS mental health scores ( P = .044). Postoperative OME consumption averaged 42.5 (range 0-416) in the entire cohort, with no differences between groups. Among patients with ≥ 1 PRA, increasing number of allergies significantly correlated with increasing OME consumption across all time points (week 1, P = .016; week 2, P = .001; total, P = .005). Conclusions: The presence of PRAs did not impact postoperative narcotic usage, pain, or satisfaction. Increasing numbers of PRAs did, however, significantly correlate with higher narcotic use. These results may have implications for postoperative pain management in this population.

Background: There is a paucity of research examining the impact of social deprivation on the level of symptom severity at presentation, including in common hand conditions like carpal tunnel syndrome. We aimed to determine whether patient deprivation is associated with worse Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity (UE), Physical Function (PF), Pain Interference (PI), and Depression scores. Methods: Patients presenting to an academic hand clinic from December 2016 to December 2018 for a new patient visit for carpal tunnel syndrome completed PROMIS UE, PF, PI, and Depression Computer Adaptive Tests. Bivariate analyses were done to compare patient variables between the least and most deprived thirds, as measured by Area Deprivation Index (ADI), at the state (New York) and national levels. Multivariable linear regression was used to determine whether there was an association between social deprivation and PROMIS UE, PF, PI, and Depression scores. Results: All PROMIS domain scores were significantly worse in the most deprived cohort at the national level ( P < .05) but not at the state level ( P > .05). In multivariable regression at the national level, ADI values were associated with PROMIS UE (β = −0.06, P < .01) and PROMIS PI (β = .05, P < .01) but not PROMIS PF or PROMIS Depression. In multivariable regression at the state level, ADI values were associated with PROMIS UE (β = −0.79, P = .03) and PROMIS PI (β = 0.58, P < .05) but not PROMIS PF or PROMIS Depression. Conclusions: Higher levels of social deprivation are associated with worse PROMIS UE and PROMIS PI scores on both the state and national levels when initially seeking care for carpal tunnel syndrome.

Background -- The definition of population-specific outcomes is an essential precondition for the implementation of value-based health care. We developed a minimum standard outcome set for overall adult health (OAH) to facilitate the implementation of value-based health care in tracking, comparing, and improving overall health care outcomes of adults across multiple conditions, which would be of particular relevance for primary care and public health populations. Methods -- The International Consortium for Health Outcomes Measurement (ICHOM) convened an international panel (patients, clinicians, and topic experts). Following the development of a conceptual framework, a modified Delphi method (supported by public consultations) was implemented to identify, in sequence, the relevant domains, the best instruments for measuring them, the timing of measurement, and the relevant adjustment variables. Findings -- Outcomes were identified in relation to overall health status and the domains of physical, mental, and social health. Three instruments covering these domains were identified: PROMIS Scale v1.2—Global Health (10 items), WHO Wellbeing Index (5 items), and the WHO Disability Assessment Schedule 2.0 (12 items). Case-mix variables included a range of sociodemographic and biometric measures. Yearly measurement was proposed for all outcomes and most case-mix variables. Interpretation -- The ICHOM OAH Standard Set has been developed through consensus-based methods based on predefined criteria following high standards for the identification and selection of high-quality measures The involvements of a wide range of stakeholders supports the acceptability of the set, which is readily available for use and feasibility testing in clinical settings.

Symptom and functional assessment is challenging in geriatric oncology care. This multicenter cross-sectional study examined the use of a multiple-symptom assessment tool, the MD Anderson Symptom Inventory (MDASI), on Chinese patients with cancer aged 65 years and older.Patient-rated symptoms and functioning were assessed using MDASI and the European Organization for Research and Treatment of Cancer quality-of-life questionnaire.The most severe symptoms were fatigue and poor appetite. The older group (75-84 years old, n = 224) reported a more severe difficulty remembering (effect size [ES] 0.32; P.001), shortness of breath (ES 0.20; P = .020), and interference with general activity (ES 0.14; P = .027), with significantly worse physical functioning (ES -0.33; P.001) and cognitive functioning on the European Organization for Research and Treatment of Cancer quality-of-life questionnaire (ES 0.20; P .001) than the younger group (65-74 years old, n = 555). For MDASI measures of the core symptoms and total interference with daily activity, Cronbach α coefficients were 0.90 and 0.93, respectively, for the younger group; and 0.93 and 0.94 for the older group, respectively. Moderate to severe (score ≥4) interference with general activity and walking on MDASI accurately indicated poor performance status (area under the curve 0.8089 and 0.7969, respectively) and lack of independence status of Activities of Daily Living (area under the curve 0.7993 and 0.8304, respectively).MDASI is psychometrically reliable, valid, and clinically sensitive for the measuring symptom burden and functional status of Chinese patients with cancer aged 65 years and older. MDASI could be adopted to measure multiple symptoms and physical functioning outcomes in geriatric oncology practice as well as for research on treatment benefits.

Objective To develop an item response theory (IRT)–calibrated, patient-reported outcome measure (the PROMIS Cancer Function Brief 3D Profile) of physical function, including associations with fatigue and social participation, in cancer rehabilitation patients. Design Large-scale field testing, graded response model IRT analyses, and multivariate regression analysis. Setting Six cancer rehabilitation clinics associated with cancer centers across the United States. Participants Adults (N=616) treated in outpatient cancer rehabilitation medicine clinics. Intervention Not applicable. Main Outcome Measures: The PROMIS(r) Cancer Function 3D Profile (including existing items from PROMIS(r) item banks). Results A total of 616 patients completed 21 items in the initial item pool. Nine items were removed because of comparatively lower information that they provide according to the IRT item calibrations, low item-total correlations, or bimodal distributions. The remaining items generated a 12-item short form. Regression analyses determined that the items were responsive to and representative of the patient population across trait ranges and multiple domains and subdomains of function. Conclusions This psychometric investigation supports the use of the PROMIS Cancer Function Brief 3D Profile for evaluating function in outpatient cancer rehabilitation patients.

To identify discrete clusters of systemic lupus erythematosus (SLE) patients based on symptoms and investigate differences across clusters.Data were collected in the US and 5 European countries via the Adelphi Real World Lupus Disease Specific Programme, a cross-sectional survey. Rheumatologists provided data for 5 consecutively consulting adult patients with SLE, who were invited to participate. Identified SLE symptoms were reduced to factors based on commonly concurrent symptoms, using principal-component factor analysis. Factors were used as covariates in a latent-class cluster analysis to identify discrete patient clusters. Patient-reported outcomes and physician-reported data were compared across clusters.Among 1,376 patients, 87% were female and 74% were White. We identified 4 patient clusters (very mild, mild, moderate, and severe) based on 39 signs/symptoms. Physician-reported symptom burden, organ involvement, disease activity, and the number of flares increased with increasing cluster severity (P 0.0001). Patient-reported impact (health status, fatigue, work productivity impairment, anxiety/depression, and emotional impact) increased with increasing cluster severity (P 0.0001). Glucocorticoid and immunosuppressant use increased, and antimalarial use decreased, with increasing cluster severity. In all clusters,20% of patients received biologics;15% of patients not receiving biologics were considered eligible for treatment by their physician. The proportion of physicians and patients satisfied with treatment decreased with increasing cluster severity (P 0.0001).Our large, international, real-world survey of SLE patients and physicians demonstrated strong associations between increased impairment, organ involvement, and humanistic burden in SLE, highlighting an unmet need for effective treatment options in patients with high disease activity.

Background This study investigated the completeness, accuracy, quality and clinical outcomes of the British Orthopaedic Foot and Ankle Society (BOFAS) registry - Ankle Arthrodesis pathway. Methods An observational study using retrospective data derived from the BOFAS registry. Adults aged ≥18 years with a record of undergoing ankle arthrodesis in the UK from 2014 to 31/10/2019 were included. Accuracy of data capture and completeness were explored using means, SD, medians and IQR for continuous variables and frequencies for categorical variables. The pre and post treatment pathway was evaluated by analysing Patient Reported Outcome Measures (PROMs) including MOXF-FQ scores for pain/walking/standing/social interaction; NRS pain; EQ-5D-5L; and EQ-5D-5L-Health VAS at baseline, 6 months, and 12 months. Results Mean age of the study population (n = 186) was 62.3 (±12.9) years and 65% of the study cohort were male. Completeness of data collection was disappointing but variables such as BMI (62.4%) smoking status (82.3%) were reasonably well recorded. PROMs scores were well recorded at baseline but rapidly declined at 6 and 12-months intervals. Reductions in MOXFQ and NRS pain scores by 12 months following surgery were statistically significant (p = 0.001 and p = 0.008), illustrating that most patients demonstrated reductions in pain intensity, improved walking/standing ability, and social interaction. Conclusion These findings illustrate the potential effectiveness of surgery on all outcomes following ankle arthrodesis that merits evaluation in a clinical trial; but also demonstrated the difficulties in obtaining representative data sets. The analyses strongly suggest that with the improvements in data quality greater resources would bring, the BOFAS registry would become a valuable tool.

Objectives Many trials conclude “no clinically meaningful detriment” to health-related quality of life (HRQL) or function between arms, even when notable differential toxicity is observed. Mean change from baseline analyses of function or HRQL can possibly obscure important change in subgroups experiencing symptomatic toxicity. We evaluate the impact of diarrhea, a key treatment arm toxicity, on patient-reported HRQL and functioning in clinical trials submitted to US Food and Drug Administration. Methods This study used 4 randomized, breast cancer trials (adjuvant to late-line metastatic) as case examples. Diarrhea, physical functioning (PF), and global health status and quality of life (GHS/QoL) from the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30 were analyzed at baseline and approximately 3 and 6 months. Results Generally, patients reporting very much diarrhea at months 3 and 6 had worse PF (9-19 points lower) and GHS/QoL (16-19 points lower) than patients reporting no diarrhea regardless of treatment arm. In the change from baseline analysis, patients reporting very much diarrhea also experienced a greater decrease in PF (6-13 points) and GHS/QoL (6-16 points) versus patients reporting no diarrhea in both arms. Conclusions In trials with moderate to large differences in symptomatic toxicity by arm, reporting “no meaningful difference in functioning and HRQL between arms” based on mean change from baseline analysis is insufficient and may obscure important impacts on subgroups experiencing symptomatic adverse events. Additional exploratory analyses with simple data visualizations evaluating functioning or HRQL in patient subgroups experiencing expected symptomatic toxicities can further inform the safety and tolerability of an investigational agent.

Introduction Depression and pain are common, disabling, mutually exacerbating conditions. Many patients living with these conditions present to community pharmacies on a regular schedule to purchase both prescribed and over-the-counter medications. Community-pharmacy based programs have been developed to improve depression and pain outcomes. Methods The PRISMA guidelines were utilized to answer the following question: In patients with depression and/or pain, what is the effect of the existing community pharmacy programs on depression and/or pain outcomes. Queried databases included Pubmed, EMBASE, and PsychINFO. DistillerSR was used to organize the screening, abstraction, and review of data. All potential articles were evaluated by two authors, and conflicts were discussed to achieve resolution. In addition to primary outcomes, sources of potential bias and quality indicators were abstracted for every article. Results Three thousand nine hundred and twenty articles were reviewed, and 13 studies met eligibility criteria (n = 7 for depression; n = 6 for pain). Most studies demonstrated improvement in measures of depression or pain. However, compared to usual care or other control conditions, most of the depression and pain-specific interventions did not provide additional symptomatic benefit. The community pharmacy-based interventions were superior for other outcomes including medication adherence, reducing stigma, improvement in self-efficacy, and improvement in general management of disease. Conclusion Community pharmacies may be uniquely positioned to deliver interventions that improve outcomes associated with successful depression and pain treatment outcomes. However, the benefits of published community pharmacy-based treatments for actually improving depression and pain severity has not yet been established. Innovative interventions and additional research may be needed to achieve clinical success for pharmacy interventions for depression and pain.

BACKGROUND A number of patient-reported outcome measure (PROMs) instruments are used to assess shoulder pain, function, and postoperative satisfaction. Computer adaptive tests (CAT) have been developed in an effort to tailor question delivery, decrease time to completion and floor/ceiling effects, and increase compliance. Previous investigations have demonstrated excellent correlation between Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity CAT (UE-CAT) and American Shoulder and Elbow Surgeons (ASES) instruments, indicating that the PROMIS UE-CAT may be an acceptable alternative to the ASES. Prior to widespread adoption, however, rigorous psychometric validation must be performed. Thus, the purpose of this study was to evaluate the psychometric properties of PROMIS UE-CAT relative to the ASES score in patients undergoing primary rotator cuff repair (RCR). METHODS A retrospective study of an institutional RCR registry was performed from July 2018 through March 2019. Preoperative PROMIS UE-CAT and ASES scores were collected. Floor and ceiling effects were determined, and convergent validity was established through Pearson correlations. Rasch partial credit modeling was used for psychometric analysis of the validity of PROMIS UE-CAT and ASES question items, a previously established methodology for assessing shoulder PROMs. Person-item maps were generated to characterize the distribution of question responses along the latent dimension of shoulder disability. RESULTS Responses from 107 patients (107 shoulders) were included. PROMIS UE-CAT had a strong correlation to ASES (r=0.684; P

OBJECTIVES To report functional outcomes of unilateral sacral fractures treated both operatively and nonoperatively. DESIGN Prospective, multicenter, observational. SETTING 16 level 1 trauma centersPatients/participants: Skeletally mature patients with unilateral zone 1 or 2 sacral fractures categorized as: displaced nonoperative (DN), displaced operative (DO), nondisplaced nonoperative (NN), nondisplaced operative (NO). MAIN OUTCOME MEASUREMENTS Pelvic displacement was documented on injury plain radiographs. Short Musculoskeletal Function Assessment (SMFA) scores were obtained at baseline and 3, 6, 12, and 24 months following injury. Displacement was defined as greater than 5 mm in any plane at the time of injury. RESULTS 286 patients with unilateral sacral fractures were initially enrolled, mean age 40 and mean Injury Severity Score (ISS) 16 were included. One hundred twenty-three patients completed 2 year follow up as follows; 29 DN, 30 DO, 47 NN, and 17 NO with 56% loss to follow-up at 2 years. Highest dysfunction was seen at 3 months for all groups with mean SMFA dysfunction scores; 25 DN, 28 DO, 27 NN, 31 NO. Mean SMFA scores at 2 years for all groups were 13 DN, 12 DO, 17 NN, 17 NO. CONCLUSIONS All groups (operative/nonoperative and displaced/non-displaced) reported worst function 3 months following injury and all but (DN) continued to recover for 2 years following injury, with peak recovery for DN seen at 1 year. No functional benefit was seen with operative intervention for either displaced or non-displaced injuries at any time point. LEVEL OF EVIDENCE Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

( limit 350 words) Objective To determine which patient reported symptoms best distinguishes patients with and without glaucoma and explains the most variance in visual field (VF) damage, and compare the amount of variance that can be explained by symptoms vs. retinal nerve fiber layer (RNFL) thickness. Design Cross-sectional study. Participants Adults diagnosed with glaucoma or suspicion of glaucoma (controls). Methods Worse-eye VF damage was defined based on perimetric testing. RNFL thickness was defined by OCT imaging. Patients rated their visual symptoms on questions collated from several published questionnaires, rating the frequency and severity of 28 symptoms on a scale of 1 (never/not at all) to 4 (very often/severe). Multivariable regression models identified patient reported symptoms that contributed the highest variance in VF damage. Main Outcome Measures Patient reported symptoms that explained the most variance in VF damage; amount of variance in VF damage explained by patient reported symptoms and RNFL Results A total of 170 patients (mean age= 64; 58% female; 47% employed) completed testing, including 95 glaucoma suspects and 75 glaucoma patients. In glaucoma patients, median mean deviation of VF damage in the worse eye was -19.3 and ranged from -5.3 to -34.7 dB. Symptoms more common amongst glaucoma patients compared to glaucoma suspects included better vision in one eye, blurry vision, glare, sensitivity to light, cloudy vision, and little peripheral vision. Worse severity ratings for the symptom ‘little peripheral vision’ explained the most variance in VF damage (43%). A multivariable model including the frequency of cloudy vision, severity of having little peripheral vision, missing patches, one eye having better vision, and vision worsening, plus sociodemographic features explained 62% of the variance in VF damage. Comparatively, a multivariable model of worse-eye RNFL thickness and sociodemographic features explained 42% of the variance in VF damage, while a model including only sociodemographic features explained 8% of the variance in VF damage. Conclusions Five patient reported symptoms explain a significant amount of the variance in VF damage. Asking patients about their symptoms may optimize patient-physician communication and be a useful adjunct to clinical testing in some patients to estimate disease severity.

Diabetic foot infections (DFI) are an increasingly common cause of hospitalizations. Once hospitalized with DFI, many patients require some level of amputation, often undergoing multiple operations. With increasing importance on patient-centered metrics, self-reported health-related quality of life (HRQOL) tools have been developed. This prospective cohort study aimed assessed the impact of DFI on HRQOL. Two hundred twenty-four patients completed the 29-item Patient-Reported Outcome Measurement Information System (PROMIS) and 12-Item Short Form (SF-12) survey. Secondary outcomes using the Foot and Ankle Ability Measures survey were obtained and included in the analysis. The study group was comprised of hospitalized patients with DFIs (n = 120), and the control group was comprised of patients with diabetes who were evaluated for routine outpatient foot care (n = 104); diabetic foot screening, wound care, onychomycosis, and/or callosities. Using this cohort, a propensity score-matched sample of hospitalized patients with DFI (n = 35) and control group patients (n = 35) was created for comparative analysis. The 2-independent sample t test was used to test for group differences on each of the PROMIS subscale outcomes. Using PROMIS, we found that hospitalized patients with DFI reported significantly worse HRQOL in 6 of 7 subscales (physical function, anxiety, depression, fatigue, social role, pain intensity; p value range: .0001-.02) compared to outpatients with diabetes evaluated for routine foot care. There was no significant difference between the 2 groups on sleep disturbance (p = .22). Patients hospitalized for DFI report lower HRQOL compared to patients with diabetes receiving routine outpatient foot care.

Introduction: Little data have been reported about the patient experience during curative radiotherapy for lung cancer in routine clinical practice, or how this relates to treatment toxicity reported by clinicians. The purpose of this study was to compare clinician-reported adverse events (AEs) with patient-reported outcomes (PROs) including both specific symptoms/side effects as well as overall quality of life (QOL) during and after definitive radiotherapy (RT) for locally advanced lung cancer (LALC) in a large statewide cohort. Methods and Materials: Patient-reported outcomes (PROs) were prospectively collected from patients treated with definitive radiotherapy for LALC at 24 institutions within the XXXX Radiation Oncology Quality Consortium between 2012-2018 using the Functional Assessment of Cancer Therapy Trial Outcome Index (FACT-TOI). Physicians prospectively recorded adverse events (AEs) using CTCAE version 4.0. Patient-reported quality of life (QOL) changes from baseline were assessed during and after radiotherapy using the FACT-TOI. Spearman correlation coefficients were calculated for AEs and similar PROs, and multivariable analysis was used to assess associations with QOL. Results: 1361 patients were included and 53% of respondents reported clinically meaningful declines in QOL at the end of RT. Correlation between clinician-reported esophagitis and patient-reported trouble swallowing was moderate (R=0.67) while correlations between clinician-reported pneumonitis and patient-reported shortness of breath (R=0.13) and cough (R=0.09) were weak. Clinician-reported AEs were significantly associated with clinically meaningful declines inpatient-reported QOL, with R=-0.46 for a summary AE-score. QOL was more strongly associated with fatigue (R=-0.41) than lung-specific AEs. Conclusions: AEs are associated with clinically meaningful declines in QOL during and after RT for LALC, but associations between AEs and QOL are only modest. This highlights the importance of PRO data, and future research should assess whether earlier detection of PRO changes could allow for interventions that reduce the frequency of treatment-related clinically meaningful declines in QOL.

Background Open radical cystectomy (ORC) is still considered the reference approach for RC, although robot-assisted RC (RARC) has recently gained in popularity. There are literature reports on perioperative and oncologic outcomes of RARC, but functional outcomes and aspects related to health-related quality of life (HRQoL) remain unexplored. Objective To report an interim analysis of 1-yr HRQoL outcomes from an ongoing randomised controlled trial comparing ORC and RARC with totally intracorporeal urinary diversion (iUD) (ClinicalTrials.gov NCT03434132). Design, setting, and participants Patients with cT2–4N0M0 non–muscle-invasive bladder cancer or bacillus Calmette-Guerin failure who were candidates for cystectomy with curative intent without absolute contraindications to robotic surgery were included. A covariate adaptive randomisation based on the following variables was used: body mass index, American Society of Anesthesiologists score, preoperative haemoglobin level, cT stage, type of UD, and neoadjuvant chemotherapy. Intervention ORC or RARC with iUD. Outcome measurements and statistical analysis Data from patient-reported European Organization for Research and Treatment of Cancer QoL questionnaires (QLQ-C30 and QLQ-BLM30) were collected at baseline and 1 yr. Continuous variables were compared using the Student t test. Results and limitations At interim analysis, 51 patients (24 RARC, 27 ORC) were analysed. Overall, both groups reported significant worsening of body image and physical and sexual functions (all p ≤ 0.012). Patients receiving ORC were more likely to report significant 1-yr impairment of role functioning, symptoms scales and bowel symptoms (all p ≤ 0.048). Patients receiving RARC reported significant impairment of urinary symptoms and problems (p = 0.018). Conclusions This study suggests equivalence between RARC-iUD and ORC for most HRQoL domains. Notwithstanding, after 1 yr patients receiving ORC were more likely to experience a decline in role functioning and higher symptoms scale, while RARC-iUD patients were more likely to report significant increases in urinary symptoms and problems. Patient summary We analysed 1-year data for health-related quality of life from an ongoing trial comparing open and robotic surgery for removal of the bladder in patients with bladder cancer. Robotic surgery seems to provide benefits for most quality-of-life items on patient-reported questionnaires. This trial is registered at ClinicalTrial.gov as NCT03434132.

Background Despite exercise being one of few strategies to improve outcomes for individuals with heart failure with preserved ejection fraction (HFpEF), exercise clinical trials in HFpEF are plagued by poor interventional adherence. Over the last 2 decades, our research team has developed, tested, and refined Heart failure Exercise And Resistance Training (HEART) Camp, a multicomponent behavioral intervention to promote adherence to exercise in HF. We evaluated the effects of this intervention designed to promote adherence to exercise in HF focusing on subgroups of participants with HFpEF and heart failure with reduced ejection fraction (HFrEF). Methods and Results This randomized controlled trial included 204 adults with stable, chronic HF. Of those enrolled, 59 had HFpEF and 145 had HFrEF. We tested adherence to exercise (defined as ≥120 minutes of moderate-intensity [40%–80% of heart rate reserve] exercise per week validated with a heart rate monitor) at 6, 12, and 18 months. We also tested intervention effects on symptoms (Patient-Reported Outcomes Measurement Information System-29 and dyspnea-fatigue index), HF-related health status (Kansas City Cardiomyopathy Questionnaire), and physical function (6-minute walk test). Participants with HFpEF (n = 59) were a mean of 64.6 ± 9.3 years old, 54% male, and 46% non-White with a mean ejection fraction of 55 ± 6%. Participants with HFpEF in the HEART Camp intervention group had significantly greater adherence compared with enhanced usual care at both 12 (43% vs 14%, phi = 0.32, medium effect) and 18 months (56% vs 0%, phi = 0.67, large effect). HEART Camp significantly improved walking distance on the 6-minute walk test (η2 = 0.13, large effect) and the Kansas City Cardiomyopathy Questionnaire overall (η2 = 0.09, medium effect), clinical summary (η2 = 0.16, large effect), and total symptom (η2 = 0.14, large effect) scores. In the HFrEF subgroup, only patient-reported anxiety improved significantly in the intervention group. Conclusions A multicomponent, behavioral intervention is associated with improvements in long-term adherence to exercise, physical function, and patient-reported outcomes in adults with HFpEF and anxiety in HFrEF. Our results provide a strong rationale for a large HFpEF clinical trial to validate these findings and examine interventional mechanisms and delivery modes that may further promote adherence and improve clinical outcomes in this population. Clinical Trial Registration : URL: https://clinicaltrials.gov/. Unique identifier: NCT01658670

Objective: The aim of this study was to explore the changes in nutritional status before dialysis initiation and to identify modifiable risk factors of nutritional status decline in older adults with advanced renal disease.& nbsp;Design and Methods: The European Quality Study on treatment in advanced chronic kidney disease (EQUAL) is a prospective, observational cohort study involving six European countries. We included 1,103 adults > 65 years with incident estimated glomerular filtration rate < 20 mL/min/1.73 m(2) not on dialysis, attending nephrology care. Nutritional status was assessed with the 7-point Subjective Global Assessment tool (7-p SGA), patient-reported outcomes with RAND-36 and the Dialysis Symptom Index. Logistic regression was used to estimate the associations between potential risk factors and SGA decline.& nbsp;Results: The majority of the patients had a normal nutritional status at baseline, 28% were moderately malnourished (SGA = 2 points). The proportion of patients with low SGA (

Background Appropriate collection of quality of life (QOL) measurements for left ventricular assist device (LVAD) patients is challenging. Patient-Reported Outcomes Measurement Information System (PROMIS) is a popular tool that has been validated across multiple disciplines, but its applicability to the LVAD population remains unknown. Methods This single-center, retrospective review included LVAD patients that completed a PROMIS assessment and Kansas City Cardiomyopathy Questionnaire (KCCQ-12) survey at clinical encounters postoperatively. Patients completed computer adaptive PROMIS assessments for physical function, pain interference and depression. All PROMIS domains are designed to follow a normal distribution (mean T-score 50, standard deviation 10) in the general population. Assessments were aggregated over time and correlation between the KCCQ-12 summary score and each PROMIS domain was assessed individually. Results A total of 178 LVAD patients were included in the study. The median time between LVAD implantation and PRO collection was 16.5 [interquartile range, 7.9-37.8] months. Patients typically had worse physical function (T-score 38.8 [33.6-44.2]) but comparable pain (51.1 [38.7-59.2]) and depression (49.9 [41.7-57.5]) as the general population. The KCCQ-12 was more strongly correlated to PROMIS physical function (Spearman’s ρ = 0.746) than pain (ρ = -0.539) or depression (ρ = -0.591). Conclusions PROMIS provides a robust QOL data collection system that can be implemented in a clinical setting without imposing a significant burden. Using this more holistic system may allow for better patient-centered care in order to address QOL limitations imposed by LVAD support that are not directly related to heart failure symptoms.

Background The content validity (appropriateness and acceptability) of patient-reported outcome (PRO) measures for scalp hair loss, eyebrow loss, eyelash loss, nail damage and eye irritation has been demonstrated in adults with alopecia areata (AA) but not adolescents. Objective To explore the content validity of the suite of AA PRO measures and accompanying photoguides in an adolescent sample. Methods Semi-structured, 90-minute, combined concept elicitation and cognitive interviews were conducted face-to-face with adolescents who experienced ≥50% AA-related scalp hair loss. Transcripts underwent thematic and framework analysis. Results Eleven adolescents (age 12-17 years, 55% female, 45% non-Caucasian/white) diagnosed with AA for 5.9 years (mean) participated. Participants had 69.6% scalp hair (mean) and current eyebrow (82%), eyelash loss (82%) and/or nail involvement (36%). Adolescents reported scalp, eyebrow and eyelash hair loss as their top three most bothersome signs/symptoms. Despite mostly accepting their AA, impacts related to visible areas of hair loss were prominent. Participants demonstrated good understanding and appropriate use of the PRO measures, and advocated including hair loss percentages alongside descriptive categories in the Scalp Hair Assessment PRO™. Results confirmed treatment success thresholds established with adults: achievement of ≤20% scalp hair loss, no/minimal eyebrow and eyelash loss, no/a little nail damage and eye irritation (PRO categories 0 or 1). Conclusions The Scalp Hair Assessment PRO™, PRO Measure for Eyebrows™, PRO Measure for Eyelashes™, PRO Measure for Nail Appearance™ and PRO Measure for Eye Irritation™ and accompanying photoguides are fit-for-purpose self-reported measures of AA signs/symptoms that are impactful to adolescents with AA.

OBJECTIVES Patient-reported quality of life (QOL) has become an important endpoint for arrhythmia surgery for atrial fibrillation (AF). While studies specifically evaluating the effect of arrhythmia surgery on QOL are scarce, we aimed to summarize current evidence of QOL following concomitant and stand-alone arrhythmia surgery for AF. METHODS All studies reporting on QOL using questionnaires from patients undergoing arrhythmia surgery for AF, both stand-alone and concomitant, were included in this systematic review. A meta-analysis was performed on inter-study heterogeneity of changes in QOL on 9 of 12 included studies that used the Short-Form 36 tool and meta-regression based on rhythm outcome after 1 year was executed. Finally, differences in QOL following stand-alone arrhythmia surgery and concomitant procedures were evaluated. RESULTS Overall, QOL scores improved 1 year after surgical ablation for AF evaluated by several questionnaires. In stand-alone arrhythmia procedures, meta-regression showed significant improvements in those who were in sinus rhythm compared to those in AF after 1 year. This association between an improved QOL and the procedural effectiveness was also suggested in concomitant procedures. However, when comparing QOL of patients undergoing cardiac surgery with and without add-on surgical ablation for AF, only the variable ‘physical role’ demonstrated a significant improvement. CONCLUSIONS In patients with AF, QOL improves after both stand-alone and concomitant arrhythmia surgery. In the concomitant group, this improvement can be attributed to both the cardiac procedure itself as well as the add-on arrhythmia surgery. However, both in stand-alone and concomitant procedures, the improvement in QOL seems to be related to the effectiveness of the procedure to maintain sinus rhythm after 12 months.

Functioning is an important outcome for the management of rheumatoid arthritis (RA). Heterogeneity of respective patient-reported outcome measures (PROMs) challenges direct comparisons between their results. This study aimed to standardize reporting of such PROMs measuring functioning in RA to facilitate comparability.Common-item nonequivalent group design with the Health Assessment Questionnaire (HAQ) as a common scale across data sets from various countries (including the UK, Turkey, and Germany) to establish a common metric was used. Other PROMs included are the physical function items of the Multidimensional HAQ (MDHAQ), the Disabilities of the Arm, Shoulder, and Hand questionnaire, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the World Health Organization Disability Assessment Schedule II (WHODAS II), the Medical Outcomes Study Short Form 36 (SF-36) health survey, and 4 short forms (20, 10, 6, and 4 physical function items) from the Patient-Reported Outcomes Measurement Information System. As the HAQ includes mobility, self-care, and domestic life items, this study focuses on these 3 domains. PROMs were described using standard error of measurement (SEM) and smallest detectable difference (SDD). A Rasch measurement model was used to create the common metric.The range of the SEM was 0.2 (MDHAQ) to 7.4 (SF-36 health survey physical functioning domain). The SDD revealed a range from 9.7% (WOMAC rating scale) to 33.5% (WHODAS physical functioning domain). PROMs co-calibration revealed fit to the Rasch measurement model. A transformation table was developed to allow exchange between PROM scores.Scores between the daily activity PROMs commonly used in RA can now be compared. Factors such as SEM and SDD help to determine the choice of a PROM in clinical practice and research.

OBJECTIVE To compare the prevalence of participants meeting different patient-reported criteria for early osteoarthritis (OA) illness after anterior cruciate ligament reconstruction (ACLR). METHODS Participants completed the Knee Injury and Osteoarthritis Outcomes Score (KOOS) at a single time-point at 5.0-7.9 months post-ACLR. We used established KOOS subscale criteria (i.e., Luyten_Original and Englund_Original) to define patient-reported early OA illness. A two-by-two contingency table and McNemar's test were used to compare the prevalence of participants that met the Luyten_Original versus Englund_Original KOOS criteria for early OA illness. These analyses were repeated using KOOS subscale thresholds based on established population-specific patient acceptable symptom state (PASS) within the Luyten and Englund KOOS criteria (i.e., Luyten_PASS and Englund_PASS). RESULTS A greater prevalence of participants with ACLR met the Luyten_Original criteria (n=165, 54%) compared to those who met the Englund_Original criteria (n=128, 42%; χ2 =19.3, p

Background Obese individuals are thought to be higher risk for complications after excisional abdominal body contouring (EAC) due to co-morbidities and significant tissue resection. Objectives We comparatively analyzed EAC patients with Body Mass Index (BMI) ≥35 kg/m2 and BMI Methods Patients ≥18 years-old undergoing EAC by a single surgeon from 01/2018-01/2020 were identified and separated into cohorts based on BMI ( Results 70 total patients with median BMIs of 30[26-32] and 41[37-45] kg/m2 in each cohort, were identified. Patients with BMI ≥35 kg/m2 were more likely to have higher ASA (P 0.05) between cohorts. Multivariate logistic regression showed that BMI ≥35 kg/m2, iNPWD and liposuction were not associated with the development of complications. PROs demonstrated improvement in multiple domains despite BMI. Conclusion There was no association with BMI ≥35 kg/m2 and the development of complications within our cohort. We encourage preoperative weight loss when possible, however these procedures can be performed safely with acceptable outcomes even in individuals who are obese and/or require extensive tissue removal.

This systematic review aims to provide an update on measurement properties of patient-reported outcome measures for pruritus. A Medline literature search was conducted to update the systematic review published by Schoch et al. in 2017 and to identify new validation studies published between October 2015 and July 2019. The methodological quality of validation studies was assessed based on the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) checklist and the measurement properties of patient-reported outcome measures were evaluated. Nineteen new studies were included and added to the 22 studies identified in the previously published review. Evidence from all 41 studies evaluating 38 different measures was summarized. Outcome measures were mapped to one of three constructs where possible: pruritus intensity, pruritus severity, pruritus-specific health-related quality of life. COSMIN rating revealed mixed results with deficiencies in methodological quality of many studies across all constructs. The most appropriate pruritus severity measure was the "Itch Severity Scale". "Itchy Quality of Life" and the disease-specific "Uremic Pruritus in Dialysis Scale" achieved most promising results considering the construct pruritus-specific health-related quality of life. For pruritus intensity, nine measures performed similarly well.

Purpose The purpose of this study was to evaluate the short-term patient-reported outcomes of superior capsular reconstruction (SCR) and identify factors contributing to the success or failure of the procedure at 2 years. Methods A retrospective review was performed on data prospectively collected from the Surgical Outcomes System database. Patient-reported outcomes (PROMs) including American Shoulder and Elbow Surgeons (ASES) score, Single Assessment Numeric Evaluation (SANE) score, visual analog scale for pain, and Veterans RAND 12-Item Health Survey (VR-12) were evaluated at a minimum of 2 years postoperatively and reported using a minimal clinically important difference (MCID) and the percent of maximal possible improvement (MPI). In addition, preoperative and intraoperative variables were evaluated in patients with and without a postoperative improvement in ASES and SANE scores meeting the threshold of MCID. Results Two-year follow-up data were available for 350 patients. Statistically significant improvements were noted in all PROMs at 2-year follow-up. In total, 240 patients (68.8%) achieved an MCID improvement of >17.5 in ASES score, and 185 patients (52.9%) achieved an MCID of >29.8 improvement in the SANE score. Primary SCRs were associated with a higher MPI in the ASES score (60.1% ± 39.8% vs 40.4% ± 47.9%; P = .025) and VR-12 physical score (14.0% ± 13.8% vs 8.0% ± 14.7%; P = .028) compared to revision repairs. Only diabetes was identified as a predictor of SANE score improvement (64.5% vs 62.2%; P = .041). Conclusions SCR is associated with improvement in patient-reported outcomes at short-term follow-up, with 53% to 69% of patients achieving an improvement considered to meet the MCID. Greater improvement is expected when SCR is performed as a primary procedure rather than as a revision procedure for failed rotator cuff repair. Level of Evidence Level III, retrospective comparative study.

Background: Mirikizumab is a humanized monoclonal antibody targeting interleukin 23p19 with demonstrated efficacy in psoriasis and ulcerative colitis. We investigated the safety and efficacy of mirikizumab in patients with moderate-to-severe Crohn's disease (CD). Methods: Patients (N = 191) were randomized (2:1:1:2) to receive placebo (PBO), 200, 600, or 1000 mg mirikizumab, administered intravenously (IV) every 4 weeks. Patients who received mirikizumab and achieved ≥1 point improvement in Simple Endoscopic Score-CD at Week 12 (rerandomized maintenance cohort) were rerandomized to continue their induction IV treatment (combined IV groups [IV-C]) or receive 300 mg mirikizumab subcutaneously (SC) every 4 weeks. Nonrandomized maintenance cohort included endoscopic nonimprovers (1000 mg) and PBO patients (PBO/1000 mg) who received 1000 mg mirikizumab IV from Week 12. The primary objective was to evaluate superiority of mirikizumab to PBO in inducing endoscopic response (50% reduction from baseline in Simple Endoscopic Score-CD) at Week 12. Results: At Week 12, endoscopic response was significantly higher by the predefined 2-sided significance level of 0.1 for all mirikizumab groups compared with PBO (200 mg: 25.8%, 8/31, 95% confidence interval [CI], 10.4–41.2, P = .079; 600 mg: 37.5%, 12/32, 95% CI, 20.7–54.3, P = .003; 1000 mg: 43.8%, 28/64, 95% CI, 31.6–55.9, P < .001; PBO: 10.9 %, 7/64, 95% CI, 3.3–18.6). Endoscopic response at Week 52 was 58.5% (24/41) and 58.7% (27/46) in the IV-C and SC groups, respectively. Frequencies of adverse events (AE) in the mirikizumab groups were similar to PBO. Through Week 52, frequencies of treatment-emergent AEs were similar across all groups. Frequencies of serious AE and discontinuations due to AE were higher in the nonrandomized maintenance cohort. Conclusion: Mirikizumab effectively induced endoscopic response after 12 weeks in patients with moderate-to-severe CD and demonstrated durable efficacy to Week 52. A detailed summary can be found in the Video Abstract. ClinicalTrials.gov, Number: NCT02891226

The MacNew questionnaire is a disease-specific quality of life measure that has been used in patients with myocardial infarction and heart failure. We aimed to investigate the impact of transcatheter aortic valve implantation (TAVI) on health-related quality of life (HRQoL) using MacNew Questionnaire and identify predictors associated with a change in its score. This was a prospective multi-center study performed across 5 National Health Service hospitals in the United Kingdom performing TAVI between 2016 and 2018. HRQoL was assessed using MacNew Questionnaire, Euro Quality of Life-5D-5L, and Short Form 36 questionnaires collected at baseline, 3-, 6- and 12 months after the procedure. Out of 225 recruited patients, 19 did not have TAVI and 4 withdrew their consent, and hence 202 patients were included. HRQoL was assessed in 181, 161, and 147 patients at 3, 6, and 12 months, respectively. Using MacNew, there was a significant improvement in all domains of HRQoL as early as 3 months after TAVI which was sustained up to 12 months with improved discrimination of change in HRQoL compared with other scales. Poor mobility at baseline and history of myocardial infarction were independent predictors of reduced improvement in HRQoL at 3 months. HRQoL increased in all subgroups of patients including frail ones. In conclusion, the MacNew assessment tool performed well in a representative TAVI cohort and could be used as an alternative disease-specific method for assessing HRQoL change after TAVI.

PURPOSE: Increased time after spinal cord injury (SCI) is associated with a migration to bladder managements with higher morbidity such as indwelling catheter (IDC). Still it is unclear how this affects bladder-related quality of life (QoL). We hypothesized that time from injury (TFI) would be associated with changes in bladder management, symptoms, and satisfaction. MATERIALS AND METHODS: Cross-sectional analysis of time-related changes in patient-reported bladder management, symptoms, and satisfaction, using the Neurogenic Bladder Research Group SCI Registry. Outcomes included: Neurogenic Bladder Symptom Score (NBSS) and bladder-related satisfaction (NBSS-satisfaction). Multivariable regression was performed to assess associations between TFI and outcomes, adjusting for participant characteristics, injury specifics, and psychosocial aspects of health-related QoL. Participants with TFI 20 years. RESULTS: Of 1420 participants, mean age at injury was 29.7(SD13.4) years and mean TFI was 15.2(SD11.6) years. Participants grouped by TFI included 298(21%) 1–5, 340(24%) 6–10, 198(14%) 11–15, 149(10%) 16–20, and 435(31%) >20 years. As TFI increased, clean intermittent catheterization (CIC) declined (55% 1–5 vs. 45% >20 years, p20 years, p20 years from injury (−3.21[CI-1.29,−5.14,p20 years −0.85[CI-1.07,−0.63

OBJECTIVE: We aimed to develop a parent-reported outcome measure for febrile infants ≤60 days of age evaluated in the emergency department. METHODS: We conducted a three-part study: 1) individual, semi-structured interviews with parents of febrile infants ≤60 days of age to generate potential items for the measure; 2) expert review with pediatric emergency medicine physicians and member-checking with parents, who rated each item’s clarity and relevance using 4-point scales; and 3) cognitive interviews with a new sample of parents, who gave feedback and rated the measure’s ease of use on a 4-point scale. The measure was iteratively revised during each part of the development process. RESULTS: In part one, we interviewed 24 parents of 21 infants. Interviews revealed several themes: parents’ experiences with medical care, communication, and decision-making; parents’ emotions, particularly worry, fear, and stress; the infant’s outcomes valued by parents; and the impact of the infant’s illness on the family. From these themes, we identified 22 potential items for inclusion in the measure. In part two, 10 items were revised for clarity based on feedback from physicians and parents, primarily under the domains of parents’ emotions and the infant’s outcomes. In part three, we further revised the measure for clarity and added an item. The final measure included 23 items and was rated as excellent in its ease of use. CONCLUSIONS: The 23-item parent-reported outcome measure includes the experiences and outcomes important to parents. Further studies are needed to evaluate the measure’s psychometric properties.

We sought to assess differences in patient-reported outcome measures (PROMs) between patients who do and do not follow up for 2 years after lumbar fusion.Primary, elective, single-level anterior lumbar interbody fusion, lateral lumbar interbody fusion, or transforaminal lumbar interbody fusion procedures were identified. Patients were grouped by 2-year PROM follow-up completion. Mean and delta PROM scores for visual analog scale (VAS) back and leg, Oswestry Disability Index (ODI), short-form (SF)-12 Physical Composite Score (PCS), and Mental Composite Score (MCS) were computed for both groups preoperatively and postoperatively. Minimum clinically important difference (MCID) achievement was determined for PROM scores using established threshold values. Linear and logistic regression assessed mean and ΔPROM scores as predictors of 2-year follow-up completion and compared MCID achievement between groups, respectively.We included 316 lumbar fusion patients. PROM scores were more favorable for complete follow-up patients for 6-month VAS back (P = 0.003), 6-month and 1-year ODI (P ≤ 0.027, both), and 6-week and 6-month SF-12 PCS (P ≤ 0.015, both). Six-month VAS back (P = 0.007); 6-month and 1-year ODI (P ≤ 0.028, both); 6-week, 6-month, and 1-year SF-12 PCS (P ≤ 0.041, all); and 6-week SF-12 MCS (P ≤ 0.028, both) significantly predicted 2-year follow-up. ΔPROMs significantly differed between groups at 1 year for ΔVAS leg (P = 0.029), ΔODI (P = 0.013), and ΔSF-12 MCS (P = 0.004). One-year ΔVAS leg (P = 0.035), ΔODI (P = 0.011), and ΔSF-12 MCS (P = 0.003) significantly predicted follow-up. MCID achievement for ΔPROMs significantly differed between groups for 6-week VAS leg (P = 0.035), overall ODI (P = 0.034), and SF-12 PCS from 12 weeks through 1 year (P ≤ 0.011, all) and overall (P0.001).Patients with full follow-up demonstrated significantly more favorable outcome scores and improvement in pain, disability, and physical function at several postoperative time points.

PURPOSE To compare Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) with traditional ("legacy") patient-reported outcome measures (PROMs) in regard to correlations, ease of use, and quality criteria for upper (UE) and lower extremity (LE) orthopaedic conditions. METHODS A systematic search of the PubMed/MEDLINE database was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to identify published articles that referenced the various PROMIS PF measures. Two authors independently reviewed selected studies. The search returned 857 studies, 85 of which were selected for independent review by 2 authors. Of these, 54 were selected for inclusion. Mixed linear models were performed to assess for differences between legacy PROMs and PROMIS measures. RESULTS The combined sample size of all included studies yielded 6,074 UE and 9,366 LE patients. Overall, PROMIS PF measures demonstrated strong correlations with legacy PROMs among UE (weighted Pearson correlation, 0.624, standard error [SE] = 0.042; weighted Spearman correlation, 0.566, SE = 0.042) and LE patients (weighted Pearson correlation, 0.645, SE = 0.062; weighted Spearman correlation, 0.631, SE = 0.041). PROMIS PF questionnaires completed by UE patients had fewer questions than legacy PROMs (5.9 vs 17.7, P = .0093) and were completed in less time (90.5 vs 223.8 seconds, P = .084). PROMIS PF questionnaires completed by LE patients had fewer questions than legacy PROMs (4.81 vs 15.33, P < .001) and were completed in less time (63.6 vs 203.2 seconds, P = .0063). The differences for the reliability measures were not significant. CONCLUSIONS PROMIS PF scores correlate strongly with commonly used legacy PROMs in orthopaedics, particularly in UE and LE patients. PROMIS PF forms can be administered efficiently and to a broad patient population while remaining highly reliable. Therefore, they can be justified for standardized use among orthopaedic patients with UE and LE conditions, improving the ability to aggregate and compare outcomes in orthopaedic research. LEVEL OF EVIDENCE Level IV, systematic review of Level I-IV evidence.

Context Systematic collection of patient-reported outcomes (PROs) reduces symptom burden and improves quality of life. The ability of older adults to complete PROs, however, has not been thoroughly studied. Objectives To determine whether older adults with advanced cancer received assistance completing PROs, the nature of the assistance, the factors associated with receiving assistance, and how the prevalence of assistance changed over time. Methods Data were obtained from a multisite cluster randomized controlled study of geriatric assessment (Clinicaltrials.gov: NCT02107443). Adults ≥70 years with advanced cancer completed multiple PROs at 4 time points (enrollment, 6 weeks, 3 months, 6 months). Factors associated with receipt of assistance were assessed with bivariate and multivariate analyses. Results The study included 541 adults (range 70-96 years, 49% female, mixed incurable cancer diagnoses). Twenty-eight percent (153/541) received assistance completing PROs. Of these, 42% received assistance from caregivers, 37% from research staff, and 15% from both. Factors associated with receiving assistance included older age [Adjusted Odds Ratio (AOR) 3.71, 95% Confidence Interval (CI) 1.03-13.38], lower education level (3.92, 2.11-7.29), impaired cognition (1.90, 1.23-2.93), impaired functional status (2.16, 1.33-3.52), and impaired hearing (1.38, 1.05-1.80). Eighty percent of individuals who received assistance were identified at study initiation. Receiving assistance decreased over time from 28% to 18%, partially due to drop-outs. Conclusion Over a quarter of older adults with advanced cancer in this study received assistance completing PROs. Completing PROs is a key aspect of many clinical programs and cancer trials; assistance in completing PROs should be offered and provided.

Objective The aim of the present study was to evaluate the psychological condition of patients with non-cured facial nerve palsy and to investigate whether their psychological condition is correlated with the degree of facial nerve palsy, synkinesis or quality of life. Methods Thirty patients with non-cured facial nerve palsy were enrolled in this study. Psychological conditions were evaluated by questionnaires including State-Trait Anxiety Inventory and Self-rating Depression Scale. Results Of the thirty patients with non-cured facial nerve palsy, 17 (56.7%) and 15 patients (50.0%) felt anxiety and depression, respectively. Although there were no significant correlations between their psychological condition and the degree of facial nerve palsy or that of sequelae, significant correlations were observed between psychological condition and the degree of QOL, especially in terms of social function. Conclusions and significance Disabilities associated with facial nerve palsy may be overlooked when evaluation is performed by physician-graded instruments alone. To resolve this problem, patients with non-cured facial nerve palsy should be evaluated by not only physician-graded tools but also patient-based assessment tools.

OBJECTIVES: This study aimed to determine whether responses to Patient-Reported Outcomes Measurement Information System Short Form v2.0 - Physical Function 8c (PROMIS PF8c) items differed when the use of a 7-day recall period was compared with no specified recall period.METHODS: Using a within-subject design, we surveyed 1810 individuals from the US general population, administering PROMIS PF8c at survey beginning and end. The order of measure presentation was randomly assigned. We calculated recall difference scores (RDSs) as no recall score minus 7-day recall score using both item response theory-based T scores and raw summed scores. We examined the distribution and created Bland-Altman plots for both RDS Tscore and RDS Raw. We also calculated correlations between no recall versus 7-day recall T score and raw scores. Finally, we determined whether differences in no recall versus 7-day recall scores were associated with patient-reported PF. RESULTS: RDS Tscore and RDS Raw had means (root mean square differences) of 0.00 (5.43) and -0.04 (3.79), respectively. The vast majority (%) of RDS Tscore and RDS Raw values fell between the Bland-Altman limits of agreement (-10.65 to 10.66 and -7.46 to 7.38, respectively). Pearson's correlations between no recall and 7-day recall for T scores and raw scores were 0.88 and 0.87, respectively. Effect sizes for mean RDS Tscore and RDS Raw compared across level of Eastern Oncology Cooperative Group performance status, patient global impression of PF severity, and single PF items were near 0. CONCLUSIONS: We did not find any significant recall period effect on PF8c responses. Therefore, we recommend the use of the PROMIS physical function standard, with no specified recall time period.

Purpose To compare minimum 2-year follow-up patient-reported outcome scores (PROs) in patients who underwent primary acetabular circumferential and segmental labral reconstruction for irreparable labral tears and femoroacetabular impingement syndrome (FAIS). Methods Data were reviewed from August 2010 to December 2017. Patients with primary labral reconstruction and minimum 2-year follow-up for the modified Harris Hip Score (mHHS), Non-Arthritic Hip Score (NAHS), Hip Outcome Score–Sports Specific Subscale (HOS-SSS), and visual analog scale (VAS) for pain were included. Circumferential and segmental reconstruction were selected in each case based on the extent of the labral pathology. Exclusion criteria were previous ipsilateral hip surgery/conditions, dysplasia, or Tonnis grade >1. Patients were propensity matched 1:1 based on age, sex, and body mass index. Secondary surgeries were reported. The P value was set at Results In total, 144 hips were eligible, and 17 hips were lost to follow-up, leaving 127 hips (88.2%) for analysis. Eighty hips underwent a segmental reconstruction, and 47 hips underwent a circumferential reconstruction. Forty-seven hips with circumferential reconstruction were matched to 47 hips with segmental reconstruction. The average follow-up and age for the segmental and circumferential groups were 29.0 ± 7.8 and 27.9 ± 7.0 months (P = .732) and 43.1 ± 9.4 and 44.7 ± 10.2 years (P = .442) respectively. The segmental and circumferential groups were 48.9% and 51.1% female, respectively. The groups achieved significant and comparable improvement for all PROs and rates of secondary surgeries. No differences were found for achieving the minimal clinically important difference (MCID) and the patient acceptable symptomatic state (PASS). The MCIDs for the segmental and circumferential groups were 76.7% and 77.8% for the mHHS, 64.9% and 77.8% for the HOS-SSS, 71.1% and 68.9% for the VAS, and 68.9% and 73.9% for the NAHS, respectively. The PASSs for the segmental and circumferential groups were 78.3% and 73.3% for the mHHS, 55.3% and 55.0% for the HOS-SSS, and 75.6% and 71.1% for the International Hip Outcome Tool 12, respectively. Conclusions At minimum 2-year follow-up, patients who underwent primary hip arthroscopy for either circumferential or segmental labral reconstruction for irreparable labra and FAIS reported significant improvement and similar postoperative scores for all PROs, with no difference in psychometric outcomes and rate of secondary surgeries. A customized approach, using the extent of the irreparable labral tear, seems to be an appropriate strategy. Level of Evidence Level III, retrospective comparative therapeutic trial.

BACKGROUND Many patient-reported outcome measures (PROMs) have been used to follow clavicle fractures, providing an objective means to track outcomes. However, lack of standardization of PROM usage makes cross-study comparison difficult. Therefore, we reviewed articles on clavicle fractures from 11 of the most influential orthopedic journals to assess trends in PROM usage over time and based on geographic location. METHODS A focused systematic review of 11 of the most influential orthopedic journals was performed using PubMed. All articles published between 1981 and 2020 with greater than 9 patients reporting clinical outcomes of clavicle fractures were included. For each article, patient demographics, treatment modality, geographic location, and outcome measures used were recorded. Temporal trends were identified using the Cochran-Armitage test for trend and linear regression. Pearson chi-square and Kruskal-Wallis tests were used to compare between journals, geographic location, study type, and fracture classification. RESULTS From the initial literature search of 623 articles, 151 studies reporting on 15,853 primary clavicle fractures were included. Fractures of the middle one-third of the clavicle were most studied in the included literature (71%). Seventeen different PROMs were used, with an average of 1.6 outcome measures per study, and there was a significant increase in the number of PROMs used per article over time (P < .001). The Constant-Murley score was the most-reported outcome measure (44%) followed by the Disabilities of the Arm, Shoulder, and Hand score (27%), visual analog scale for pain (23%), and American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES; 14%). There was a significant difference between the measures used based on geography (P = .002), the most notable being that North American authors use the ASES score more frequently. CONCLUSIONS The use of PROMs in studies evaluating clavicle fracture treatment outcomes has increased over time, with recent studies reporting more PROMs than older studies, and there are notable differences in usage of the various scores based on geography and journal. Although there is no consensus on the most reliable PROM for assessing clavicle fractures, we recommend the use of at least 2 of the commonly reported PROMs in future studies to facilitate cross-study comparisons.

BACKGROUND: In oncology, especially with accelerated regulatory approvals and niche populations, US payers appreciate all evidence that can help support formulary decision making, including evidenc...

Objective To estimate the association between discussion of all options (adoption, abortion, and parenting) in pregnancy options counseling and patient-reported experience with counseling. Study Design Patients (n = 316) who received a positive pregnancy test Oct 2018-June 2019 at one of 14 randomly selected clinics in a southern US publicly funded family planning system participated in an anonymous digital survey about their experience with counseling. The survey assessed which options (parenting, adoption, abortion) they discussed with their provider and how they rated their counseling experience using a 20-item scale based on validated measures of patient reproductive health counseling experience. We used Poisson regression to estimate the prevalence ratio for discussing all pregnancy options and rating their provider with a perfect score. Results Approximately 10% of patients reported their provider discussed all options. After adjustment for patient, provider, and clinic characteristics, patients were approximately 80% more likely to rate their counseling as “excellent” on all analyzed scale items when their provider discussed all options compared to when they did not (adjusted prevalence ratio [aPR] = 1.80, 95% CI: 1.43, 2.28). Discussion of all pregnancy options was associated with a more positive patient-reported experience among patients who planned to continue their pregnancy (aPR = 1.82, 95% CI: 1.37, 2.42) and among those who did not (aPR = 1.62, 95% CI: 1.08, 2.44). Patients whose provider had received options counseling training were more likely to report all options were discussed. Conclusion Discussion of all options during pregnancy counseling is associated with a more positive patient experience. These findings indicate patient preference for supportive, nondirective counseling on all pregnancy options. Implications Our study's findings support nondirective discussion of all pregnancy options (including parenting, abortion and adoption) as a best practice, and stand in contrast to regulations that restrict discussion of all options.

Purpose We estimated the minimal clinically important difference (MCID) for the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) and Pain Interference (PI) computer adaptive tests (CATs) following surgical treatment of distal radius fracture (DRF). Methods Adult patients surgically treated between November 2017 and November 2020 for isolated DRF were identified. Demographic and patient-reported outcome data were extracted from the electronic health record . Outcomes of interest were the PROMIS PF and PI CATs. Inclusion criteria were met if: (1) PROMIS PF and PI scores were available at preoperative and postoperative visits; and (2) a postoperative clinical anchor question asking about overall response to treatment was answered. An anchor-based MCID estimate was determined by calculating the average absolute score change in PROMIS PF and PI for patients who indicated a mild change to the anchor question. A distribution-based MCID estimate was also calculated using the standard error of measurement and effect sizes of change. Results The changes in PROMIS PF and PI scores were significantly different between patients who gave responses of much change (n = 73), mild change (n = 51), and no change (n = 19) to the clinical anchor question. The average score changes in the mild change group for PROMIS PF and PI were 5.2 (SD, 3.7) and 6.8 (SD, 4.3) points, respectively, representing the anchor-based MCID estimates. The PROMIS PI anchor-based estimate was moderately correlated with the preoperative score (r = −0.41), time between visits (r = −0.39), and age (r = 0.30). The distribution-based MCID estimates were 3.8 (SD, 1.3) and 3.7 (SD, 1.3) points for the PROMIS PF and PI, respectively. Conclusions The MCIDs were estimated as 5.2 and 6.8 for the PROMIS PF and PI CATs, respectively, following surgery for DRF. Clinical relevance As reports continue to publish a consistent range of MCID values, researchers can be confident in these values and begin using them across a broader spectrum of conditions treated by hand surgeons.

Background There are three patient reported outcome measure instruments (PROMs) that have adequate content validity for breast reconstruction, BREAST-Q, BRECON-31 and EORTC QLQ-BRECON-23, and they all have been robustly validated. The aim of this study was to systematically review scores giving meaning to validated PROMs for breast reconstruction after mastectomy and discuss methods to enable interpretation of them. Methods A systematic review was performed according to the recommendations of PRISMA. Prospero CRD42021255874. Included articles had to meet criteria defined in a SPIDER (Sample, Phenomenon of Interest, Design, Evaluation, Research type). The included studies were critically appraised using the GRADE approach. Results Three articles were finally included in the review: two studies on scores for healthy controls and one on minimally important differences (MIDs), both of BREAST-Q. All of the studies were performed in North America. Only MIDs based on statistical characteristics, and not on what constitutes a relevant change for the patient, exist. The risk of bias was evaluated as very high and moderate, respectively, of inconsistencies as low, of indirectness as high, of imprecisions as low, and of publication bias as probably low. Conclusions The overall certainty of evidence for scores giving meaning to PROMs for breast reconstruction is low (GRADE ƟƟОО). More studies are needed to establish relevant healthy control scores and what constitutes a relevant clinical difference for patient-reported outcome measures for breast reconstruction after mastectomy. Clinical implications of the findings and suggestions for further research are suggested in the article., Highlights • Patient reported outcome measurements have to be clinically interpretable to make sense. • Three articles on scores giving meaning to PROMs for breast reconstruction post-mastectomy exist. • More studies are needed to establish relevant controls and clinical differences in scores. • Clinical implications and suggestions for further research are discussed.

Background and purpose — Knowing how to interpret values obtained with patient reported outcome measures (PROMs) is essential. We estimated the substantial clinical benefit (SCB) and patient acceptable symptom state (PASS) for Forgotten Joint Score 12 (FJS) and explored differences depending on methods used for the estimates. Patients and methods — The study was based on 195 knee arthroplasties (KA) performed at a university hospital. We used 1 item from the Knee injury and Osteoarthritis Outcome Score domain quality of life and satisfaction with surgery, obtained 1-year postoperatively, to assess SCB and PASS thresholds of the FJS with anchor-based methods. We used different combinations of anchor questions for SCB and PASS (satisfied, satisfied with no or mild knee difficulties, and satisfied with no knee difficulties). A novel predictive approach and receiver-operating characteristics curve were applied for the estimates. Results — 70 and 113 KAs were available for the SCB and PASS estimates, respectively. Depending on method, SCB of the FJS (range 0–100) was 28 (95% CI 21–35) and 22 (12–45) respectively. PASS was 31 (2–39) and 20 (10–29) for satisfied patients, 40 (31–47) and 38 (32–43) for satisfied patients with no/mild difficulties, and 76 (39–80) and 64 (55–74) for satisfied patients with no difficulties. The areas under the curve ranged from 0.82 to 0.88. Interpretation — Both the SCB and PASS thresholds varied depending on methodology. This may indicate a problem using meaningful values from other studies defining outcomes after KA. This study supports the premise of the FJS as a PROM with good discriminatory ability in patients undergoing KA.

Objective Healthcare experiences, quality of life and psychosocial needs of patients with Neuroendocrine tumours (NETs) will be assessed to identify differences between NET sub-groups and inform the design of supportive care services. Methods This study constitutes phase one of a three-phase mixed-methods multi-site study with NET patients (n = 123). Demographic, clinical and patient reported outcome questionnaire data was collected. Results No differences in patient reported outcomes were found beyond symptoms of diarrhoea and flushing between NET sub-groups. For combined NET patients, the majority reported negative experiences in their understanding of the explanation of what was wrong with them (67%); receiving written information about their cancer (69%), their family/carer receiving all the information required to care for them (61%); and the usefulness of information about NETs online (66%). NET patients reported at least one moderate-to-high need for disease specific information (63%). Medium- to large-sized differences in quality of life subscales were also observed with the functioning group reporting more anxiety compared to population norms. Conclusions There is a need to improve the current provision of information for people with NETs. Practice implications These findings will inform the design and development of an informational resource to facilitate improved understanding for patients with NETs.

Purpose This study aimed to determine whether continual electronic patient-reported outcome (ePRO) measurements at home can capture the fluctuations in health-related quality of life (HRQOL) scores between visits. Methods We performed a randomized controlled trial to compare the scores obtained by standard practice (paper-based measurements in the hospital) to scores by continuous measurement of ePRO at home. Metastatic cancer patients were randomly assigned to either the paper-based ( n = 50) or the ePRO group ( n = 52). EQ-5D-5L and EORTC QLQ C-30 scores were obtained on 3 different chemotherapy days in the paper-based group. Meanwhile, scores were obtained on the chemotherapy day and on days 3, 7, 10, and 14 in the ePRO group during 2 cycles. The first hypothesis of our study was that both scores at the same time points would be equivalent despite different measurement frequency, place, or mode of measurement. The second hypothesis was that PRO score–adjusted time would be different between the groups. For equivalence, the endpoint was the mean EQ-5D-5L index value on the chemotherapy day before the outpatient treatment. Only if equivalence was shown, quality-adjusted life-days (QALDs) were considered using all the data. Results The adjusted mean difference in the EQ-5D-5L index was determined to be −0.013 (95% confidence interval [CI]: −0.049 to 0.022); the 95% CI did not exceed the equivalence margin. Similarly, the mean difference in global health status (2.28 [95% CI: −2.55 to 7.11]) also showed equivalence. However, the QALD by EQ-5D-5L was significantly lower in the ePRO group by 1.36 per 30 d (95% CI: −2.22 to −0.51; P = 0.0021). Conclusions Continual measurements of the HRQOL at home by ePRO may yield more detailed profiles of the HRQOL.