Life Measures Research Articles

Using random forest to identify correlates of depression symptoms among adolescents.

Adolescent depression is a significant public health concern, and studying its multifaceted factors using traditional methods possess challenges. This study employs random forest (RF) algorithms to determine factors predicting adolescent depression scores. This study utilized self-reported survey data from 56,008 Canadian students (grades 7-12) attending 182 schools during the 2021/22 academic year. RF algorithms were applied to identify the correlates of (i) depression scores (CESD-R-10) and (ii) presence of clinically relevant depression (CESD-R-10 ≥ 10). RF achieved a 71% explained variance, accurately predicting depression scores within a 3.40 unit margin. The top 10 correlates identified by RF included other measures of mental health (anxiety symptoms, flourishing, emotional dysregulation), home life (excessive parental expectations, happy home life, ability to talk to family), school connectedness, sleep duration, and gender. In predicting clinically relevant depression, the algorithm showed 84% accuracy, 0.89 sensitivity, and 0.79 AUROC, aligning closely with the correlates identified for depression score. This study highlights RF's utility in identifying important correlates of adolescent depressive symptoms. RF's natural hierarchy offers an advantage over traditional methods. The findings underscore the importance and additional potential of sleep health promotion and school belonging initiatives in preventing adolescent depression.

Quality of life measures with etripamil self-administration for acute episodes of paroxysmal supraventricular tachycardia in a medically unsupervised setting: patient-reported outcomes from NODE-303

Abstract Background Etripamil nasal spray (NS) is a fast-acting, self-administered calcium-channel blocker in development for the conversion of AV-nodal dependent paroxysmal supraventricular tachycardia (PSVT) in a medically unsupervised setting. Prior studies show favorable safety and efficacy in converting single episodes of PSVT to sinus rhythm (SR). Purpose In NODE-303, patient-reported outcome (PRO) instruments assessed quality of life (QoL) over multiple etripamil-treated episodes of PSVT. Methods NODE-303 was an event-driven, multi-center, open-label Phase 3 study in North and South American patients with documented PSVT that evaluated the safety and efficacy of etripamil in PSVT termination, over multiple episodes and without the need for prior test dosing. Enrolled patients who perceived PSVT symptoms applied an ambulatory ECG cardiac monitoring system (CMS), performed a pre-trained vagal maneuver and, if symptoms persisted, self-administered etripamil NS 70 mg. A study amendment allowed a repeat dose (etripamil NS, 70 mg) if symptoms persisted 10 min after the first dose. Each patient could self-treat up to 4 episodes. Safety was assessed through adverse events, clinical data, and ECG CMS recordings. The Treatment Satisfaction Questionnaire for Medication (TSQM; validated for acute episodic assessments) and other PROs were administered, and healthcare utilization data were acquired. Patients completed PROs at baseline (BL), monthly, and per PSVT episode, which collected information on symptoms, episode characteristics, rescue medications, and emergency room visits. Additional PROs were the Brief Illness Perception Questionnaire (BIPQ), Cardiac Anxiety Questionnaire (CAQ), and 36-Item Short Form Health Survey (SF-36). Results There were higher proportions of patients reporting mild, minimal or no disease severity, every 6 months, than at BL; extremely severe, severe, and moderate disease severity was reported by smaller proportions of patients than at BL, though incomplete surveys at later visits may limit this analysis. Anxiety and stress about future PSVT episodes were consistently reduced from BL. Measures of treatment satisfaction, effectiveness, and convenience were consistent across multiple episodes, and were at levels considered favorable for the TSQM instrument (Table 1). Rates of emergency-room visits and hospital admissions across multiple, treated PSVT episodes were similar to those observed in trials assessing single episodes (Table 2). The BIPQ, CAQ or SF-36 had no notable changes from BL. Conclusions Etripamil self-administration was associated with patient-reported improvements in degree of disease severity, decreased anxiety and stress over future PSVT episodes, and levels of treatment satisfaction, effectiveness, and convenience considered favorable for respective PRO instrument. Using a symptom-prompted, self-administered treatment for PSVT could potentially improve QoL measures and reduce healthcare resource utilization.

The impact of a dedicated heart failure clinic on patients with heart failure with reduced ejection fraction

Abstract Introduction Heart failure (HF) is not a diagnosis but rather a syndrome with a variety of potential causes and once a patient has been diagnosed as having HF, the underlying etiology should be sought and treated. Thus, patients with HF should be engaged in a disease management program that includes a dedicated wider healthcare team which is critical for delivering the best care for patients. A dedicated HF clinic is one of the cornerstones of this ultimate management program. This clinic is specifically made to make sure of the proper management and follow-up of those patients. There is a scarce evidence of weather a dedicated HF clinic can alter the long-term outcomes of HF patients or not. Thus, the aim of this study is to search for the impact of a dedicated HF clinic on patients with HF with reduced ejection fraction (HFrEF) regarding the symptoms, management received according to latest guidelines, the patients’ quality of life and impact on health care resources. Patients and Methods This is a single center retrospective study that included patients presented to a dedicated heart failure clinic at a secondary care hospital through a one-year period. The study group included patients with diagnosis of HFrEF only who had one or more visit to the HF clinic. These patients served as their own control. Hospital admissions and emergency room visits in the 12-month period preceding enrollment was compared to the number in the following year after enrollment. Patients with incomplete data and those with ejection fraction >40% were excluded. Results The study included 48 patients with a mean age of 65 years, 70.8% of them were males. Most of the patients were hypertensive (77.1%), diabetic (75%) and with history of coronary artery disease (60.4%). Symptoms improved significantly in all patients, left ventricular volumes and ejection fraction improved (31±8.1% vs 40.7±10.5%) (P<0.0001). NT-ProBNP level improved significantly (5927 ng/L vs 3135 ng/L) (P = 0.03). The guideline directed medical therapy was used properly before and after the clinic. There was a significant improvement in the quality of life where the KCCQ-12 score improved from 71.25±13.2 to 83.3±13.3 (P<0.0001), six-minute walk test also improved significantly from 362±184 meters to 479±211 meters (P = 0.005). Regarding the economic impact, there was no significant difference in the number of unplanned visits (20.8% vs 10.4%) (P = 0.16) but there was a significant reduction in the number of HF hospitalizations within one year (20.8% vs 6.25%) (P = 0.038) Conclusion Dedicated HF clinics are very important now for the proper management of HF patients where it is proved that it can improve HF symptoms, improve the quality of life measurements, maintain the proper guideline directed therapy and reduce the economic burden of HF through reducing the number of HF hospitalizations.Clinical dataOutcomes

The Short Form 6 Dimensions (SF-6D): Development and Evolution.

This paper considers the development and evolution of the short-form 6 dimensions (SF-6D), a generic preference-weighted measure consisting of a health classification with accompanying value set that was developed from one of the widest used health related quality of life measures, the SF-36 health survey. This enabled health state utility values to be directly generated from SF-36 and SF-12 data for a range of purposes, including to produce quality adjusted life years for use in economic evaluation of healthcare interventions across a range of different conditions and treatments. This paper considers the rationale for the development of the measure, the development process, performance and how the SF-6D has evolved since its conception. This includes the development of an updated version, SF-6D version 2 (SF-6Dv2), which was generated to deal with some criticisms of the first version, and now includes a standalone version for inclusion in studies without relying on use of SF-36 or SF-12. Valuation methods have also evolved, from standard gamble in-person interviews to online discrete choice experiment surveys. International work related to the SF-6Dv1 and SF-6Dv2 is considered. We also consider recommendations for use, highlighting key psychometric evidence and reimbursement agency recommendations.

Determining the Severity of Benign Urologic Health States in Men Using Utilities Measures

ObjectivesTo assess a population level perceived health status of common reconstructive urologic conditions using health utilities. MethodsHealth utilities are generic quality of life measures that can help describe overall health status and can quantitatively compare different disease states and the perceived benefits of various interventions. An a priori determined, representative sample of adult men were recruited by Qualtrics™ to review standardized scenarios describing typical patients with reconstructive urologic conditions, surgeries to treat conditions, and control conditions (e.g. blindness, osteoarthritis). Condition-specific health status was measured using four tools: visual analog scale, standard gamble, time-trade off and willingness-to-pay and reported in Quality-adjusted Life Years (QALY; range 0.0 (death) to 1.0 (perfect health)). ResultsWe analyzed 562 completed surveys from condition-naive participants. Condition-specific health status ranged from a mean of 0.52 QALY to 0.66 QALY, with all reconstructive conditions perceived to be worse than osteoarthritis and monocular blindness (QALY 0.68). Health status was lowest for adult acquired buried penis (0.52 QALY) and pelvic radiation disease (0.53 QALY), comparable to binocular blindness (QALY 0.52). Treatment of erectile dysfunction with inflatable penile prosthesis (∆QALY +0.02; p<0.001) and stress urinary incontinence with artificial urinary sphincter (∆QALY +0.04; p<0.001) offered only nominal perceived gain in health status. ConclusionsHealth utilities may improve the ability to discriminate between heterogeneous reconstructive urologic disease states. For non-oncologic disease states in which mortality is not measured, health utilities could improve the ability to measure societal impact and justification for clinical and research investment.

The psychometric properties of Chinese version of the Gilles de la Tourette syndrome-quality of life scale (GTS-QOL) for children and adolescents

BackgroundGilles de la Tourette syndrome (GTS) is a persistent neurological disorder that profoundly affects the quality of life for afflicted individuals, however, tailored health-related quality of life (QOL) measures for Chinese pediatric GTS patients are lacking. This pioneering study aims to develop a QOL scale for Chinese children with GTS.MethodsA cohort of 1,121 children (aged 6–16 years) diagnosed with GTS participated in scale development. Internal consistency was evaluated using Cronbach’s alpha. Exploratory factor analysis (EFA) and confirmatory factor analysis (CFA) were performed to assess the factor structure of the GTS-QOL-Chinese, examining goodness-of-fit indices, factor loadings of individual items, and covariances between factors. Validity was determined through interscale correlations and comparisons with external measures to establish convergent and discriminant validity.ResultsFollowing reliability and validity analyses, a Chinese version of the 24-item GTS-specific quality of life scale was conclusively established, encompassing five subscales (psychological, compulsive, cognitive, physical, social). The scale demonstrated high internal consistency with a Cronbach’s alpha coefficient of 0.93, and validity was substantiated through interscale correlations ranging from 0.46 to 0.68. EFA identified five factors, explaining 61.26% of the total variation. CFA further confirmed the scale’s robustness, with all goodness-of-fit indicators meeting acceptable criteria (AGFI = 0.86, PCFI = 0.78, GFI = 0.89, CFI = 0.89, RMSEA = 0.07, SRMR = 0.06).ConclusionsThe Chinese version of the GTS-QOL scale has exhibits robust reliability and validity and is valuable for assessing the quality of life of Chinese children and adolescents with GTS. This scale may assist in tailoring interventions and improving patient care.

Ventral hernia repair with permanent mesh for non-Hispanic black versus white patients: access and post-operative outcomes in the era of robotic surgery.

Robotic ventral hernia surgery may provide better patient outcomes. Whether it is provided equitably based on race remains unknown. We examined whether patients from the Abdominal Core Health Quality Collaborative who were Black had equitable access to robotic surgery for ventral hernia repair with permanent mesh compared to white counterparts from 2013 to 2023. We performed propensity-score matching to address confounding and then chi-squared testing to examine access to robotic, laparoscopic, and open approaches. Secondary outcomes included 30-day readmissions, complications, and death and 1- and 2-year hernia recurrence and quality of life measured by HerQLes Summary and PROMIS Pain T-Scores analyzed with chi-squared, Fisher exact, and Wilcoxon testing. 2397 patients identified as Black, and 21,900 identified as white. Our propensity-score matched cohort included 2374 Black patients and 7122 white. Black and white groups had the same rates of laparoscopy (15% vs 15%). Patients who identified as Black were more likely to undergo robotic surgery (36% vs 32%). Open approach was 49% for Black and 53% for white (p = 0.005). For 30-day complications, we found Black patients were more likely to experience reoperation (2% vs 1%, p = 0.005) and less likely surgical site infection (1% vs 2%, p < 0.001). Hernia recurrence scores and perceived abdominal health based on HerQLes were not statistically significantly different. At 2years, absolute reported T-Scores were higher for Black patients (median 40 (IQR 31-49) vs 36 (31-46), p = 0.031). This is the first large-scale study examining access to robotic surgery, complications, and quality of life measures. We found patients who identified as Black were more likely than white counterparts to undergo robotic surgery, but they were more likely to require reoperation and had higher pain scores. Our data suggest equitable access still may not translate to equitable patient outcomes.

Associations between oral health impacts attributed to malocclusion and normative and self-perceived orthodontic treatment need in Turkish adolescent patients.

In the socio-dental approach, the integration of normative oral health-related quality of life (OHRQoL) and behavioral propensity measures should be considered when assessing treatment needs and planning oral services. Therefore, this study aimed to evaluate the relationship between oral health impacts attributed to malocclusion and normative and self-perceived orthodontic treatment needs in adolescent patients and to determine the clinical, sociodemographic, and behavioral factors affecting their OHRQoL. This cross-sectional study was conducted using a convenience sample size of 105 adolescent patients aged 11-14 years who were referred to the Orthodontics Clinic in the Faculty of Dentistry, Istanbul. Data were collected using clinical examinations and a self-reported questionnaire, including the condition-specific Child Oral Impact on Daily Performances (CS-COIDP) attributed to malocclusion and sociodemographic, clinical, and behavioral factors. The index of complexity, outcome, and need (ICON), gingival index, and Decayed, Missing, Filled Teeth index was used to assess oral health status. Descriptive statistics and bivariate and multivariate regression analyses were used for the data analyses. A total of 70 patients (66.7%) reported at least one impact. Furthermore, 47% of the adolescents had very difficult and difficult complexity grades. The most affected performances were "emotional (52.4%) and smiling (40%)". No significant differences were found in the total CS-COIDP scores according to caries experience; however, the gingival status was associated with the total OHRQoL. Lower tooth brushing frequency, increased malocclusion complexity, and subjective treatment need were the most important predictors of worse OHRQoL, accounting for 39.3% of the variance in the scores. ( R2 = 0.422; p < 0.001) CONCLUSIONS: Oral health professionals should consider oral behaviors, malocclusion complexity, and subjective treatment need when planning orthodontic treatment plans. Integrating ICON, CS-COIDP, and behavioral assessment will help identify adolescents who should be prioritized for treatment.

Effectiveness of a 12-week combining tai chi and yoga program on pulmonary function and functional fitness in COPD patients

BackgroundChronic obstructive pulmonary disease (COPD) poses significant challenges to both patients and healthcare providers due to its progressive nature and adverse impact on respiratory function and quality of life (QoL). While pulmonary rehabilitation remains a cornerstone of non-pharmacological COPD management, additional interventions are needed to address patients' diverse needs and preferences. AimThis study investigated the feasibility and potential benefits of a 12-week combining Tai Chi and Yoga (TY combining) program on cardiorespiratory and lung functions, functional fitness, and QoL in older males diagnosed with COPD. MethodsTwenty-four male COPD patients (age: 70 ± 6 years) with moderate to severe disease were recruited and randomized into the TY combining group (n = 12) or control group (n = 12). Assessments were conducted at baseline and at week 12, including pulmonary function tests, quality of life measures, dyspnea, and fatigue. Functional fitness tests were assessed at baseline, week 4, week 8, and week 12. ResultsThe TY combining program significantly improved pulmonary functions, functional fitness, quality of life, and fatigue over the 12-week intervention period. Notably, improvements in functional fitness parameters were observed after just four weeks of training, emphasizing the rapid benefits of the intervention. Moreover, the program exhibited high safety and feasibility, with no reported complications. ConclusionThe 12-week TY combining program represents a safe, feasible, and effective adjunctive therapy for COPD management in older male patients. By addressing multiple dimensions of health and functioning, including pulmonary and cardiovascular health, functional fitness, and quality of life, this holistic approach holds promise for optimizing outcomes in COPD patients. Further research is warranted to validate these findings and explore optimal implementation strategies in clinical practice.

Chronic Overlapping Pain Conditions in people with Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS): a sample from the Multi-site Clinical Assessment of ME/CFS (MCAM) study

BackgroundChronic overlapping pain conditions (COPCs), pain-related conditions that frequently occur together, may occur in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and could impact illness severity. This study aimed to identify comorbid COPCs in patients with ME/CFS and evaluate their impact on illness severity.MethodsWe used data from 923 participants in the Multi-Site Clinical Assessment of ME/CFS study, conducted in seven U.S. specialty clinics between 2012 and 2020, who completed the baseline assessment (595 ME/CFS and 328 healthy controls (HC)). COPCs included chronic low back pain (cLBP), chronic migraine/headache (cMHA), fibromyalgia (FM), interstitial cystitis/irritable bladder (IC/IB), irritable bowel syndrome (IBS), temporomandibular disorder (TMD). Illness severity was assessed through questionnaires measuring symptoms and functioning. Multivariate analysis of variance and analysis of covariance models were used for analyses. Log-binomial regression analyses were used to compute prevalence of COPCs and prevalence ratios (PR) between groups with 95% confidence intervals. Both unadjusted and adjusted results with age and sex are presented.Results76% of participants with ME/CFS had at least one COPCs compared to 17.4% of HC. Among ME/CFS participants, cMHA was most prevalent (48.1%), followed by FM (45.0%), cLBP (33.1%), and IBS (31.6%). All individual COPCs, except TMD, were significantly more frequent in females than males. The unadjusted PR (ME/CFS compared to HC) was highest for FM [147.74 (95% confidence interval (CI) = 20.83-1047.75], followed by cLBP [39.45 (12.73-122.27)], and IC/IB [13.78 (1.88-101.24)]. The significance and order did not change after age and sex adjustment. The COPC comorbidities of cLBP and FM each had a significant impact on most health measures, particularly in pain attributes (Cohen’s d effect size 0.8 or larger). While the impact of COPC comorbidities on non-pain attributes and quality of life measures was less pronounced than that on pain, statistically significant differences between ME/CFS participants with and without COPCs were still evident.ConclusionsMore than 75% of ME/CFS participants had one or more COPCs. Multiple COPCs further exacerbated illness severity, especially among females with ME/CFS. Assessment and management of COPCs may help improve the health and quality of life for patients with ME/CFS.

Preparing for responsive management versus preparing for renal dialysis in multimorbid older people with advanced chronic kidney disease (Prepare for Kidney Care): Study protocol for a randomised controlled trial.

BackgroundChronic kidney disease (CKD) prevalence is steadily increasing, in part due to increased multimorbidity in our aging global population. When progression to kidney failure cannot be avoided, people need unbiased information to inform decisions about whether to start dialysis, if or when indicated, or continue with holistic person-centred care without dialysis (conservative kidney management). Comparisons suggest that while there may be some survival benefit from dialysis over conservative kidney management, in people aged 80 years and over, or with multiple health problems or frailty, this may be at the expense of quality of life, hospitalisations, symptom burden and preferred place of death. Prepare for Kidney Care aims to compare preparation for a renal dialysis pathway with preparation for a conservative kidney management pathway, in relation to quantity and quality of life in multimorbid, frail, older people with advanced CKD.MethodsThis is a two-arm, superiority, parallel group, non-blinded, individual-level, multi-centre, pragmatic trial, set in United Kingdom National Health Service (NHS) kidney units. Patients with advanced CKD (estimated glomerular filtration rate < 15 mL/min/1.73 m2, not due to acute kidney injury) who are (a) 80 years of age and over regardless of frailty or multimorbidity, or (b) 65–79 years of age if they are frail or multimorbid, are randomised 1:1 to ‘prepare for responsive management’, a protocolised form of conservative kidney management, or ‘prepare for renal dialysis’. An integrated QuinteT Recruitment Intervention is included. The primary outcome is mean total number of quality-adjusted life years during an average follow-up of 3 years. The primary analysis is a modified intention-to-treat including all participants contributing at least one quality of life measurement. Secondary outcomes include survival, patient-reported outcomes, physical functioning, relative/carer reported outcomes and qualitative assessments of treatment arm acceptability. Cost-effectiveness is estimated from (i) NHS and personal social services and (ii) societal perspectives.DiscussionThis randomised study is designed to provide high-quality evidence for frail, multimorbid, older patients with advanced CKD choosing between preparing for dialysis or conservative kidney management, and healthcare professionals and policy makers planning the related services.Trial registrationISRCTN, ISRCTN17133653 (https://doi.org/10.1186/ISRCTN17133653). Registered 31 May 2017.

Iontophoresis Improves the Impact on the Quality of Life of Children with Primary Hyperhidrosis-A Prospective Study and a Short Review.

Primary hyperhidrosis (PH) is a somatic and idiopathic pediatric skin disease. The eccrine glands are tiny and very numerous, with approximately 3 million distributed throughout the skin. There is no commonly accepted amount of sweating to define hyperhidrosis, but people with this disease suffer real limitations integrating into society, which can be quantified through quality of life measurement scales. We want to draw attention to this disease and its impact on children's quality of life because it is significant and there are no studies conducted on groups consisting solely of children. There are various quality of life evaluation questionnaires for hyperhidrosis. We studied 103 children with hyperhidrosis by monitoring their sweat severity and its impact on quality of life, using the Hyperhidrosis Disease Severity Scale. We compared the scale results before and after 10 days of iontophoresis. This study includes only children under 18 years old, treated with iontophoresis. The average age of the group is 11.84 ± 2.89 years. Treatment success is recorded in 68 (66.02%) children, but a change in the score is recorded in 74 (71.84%) children. The average HDSS score at T0 is 2.95 ± 0.70, compared to the HDSS score at T1 of 1.92 ± 0.86. Hyperhidrosis has a negative impact on daily life, especially self-esteem, occupational productivity, emotional well-being, and interpersonal relationships. Iontophoresis is a safe and effective treatment method that reduces the severity of hyperhidrosis and increases the quality of life.

A Core set of patient-reported outcome measures to measure quality of life in obesity treatment research.

The lack of standardization in patient-reported outcome measures (PROMs) has made measurement and comparison of quality of life (QoL) outcomes in research focused on obesity treatment challenging. This study reports on the results of the second and third global multidisciplinary Standardizing Quality of life measures in Obesity Treatment (S.Q.O.T.) consensus meetings, where a core set of PROMs to measure nine previously selected patient-reported outcomes (PROs) in obesity treatment research was established. The S.Q.O.T. II online and S.Q.O.T. III face-to-face hybrid consensus meetings were held in October 2021 and May 2022. The meetings were led by an independent moderator specializing in PRO measurement. Nominal group techniques, Delphi exercises, and anonymous voting were used to select the most suitable PROMs by consensus. The meetings were attended by 28 and 27 participants, respectively, including a geographically diverse selection of people living with obesity (PLWO) and experts from various disciplines. Out of 24 PROs and 16 PROMs identified in the first S.Q.O.T. consensus meeting, the following nine PROs and three PROMs were selected via consensus: BODY-Q (physical function, physical symptoms, psychological function, social function, eating behavior, and body image), IWQOL-Lite (self-esteem), and QOLOS (excess skin). No PROM was selected to measure stigma as existing PROMs deemed to be inadequate. A core set of PROMs to measure QoL in research focused on obesity treatment has been selected incorporating patients' and experts' opinions. This core set should serve as a minimum to use in obesity research studies and can be combined with clinical parameters.

Long-term patient reported outcomes after robotic, laparoscopic, and open ventral hernia repair.

Current evidence demonstrates questionable incremental benefit of robotic abdominal wall (ventral) hernia repair when compared to other approaches. However, data are mainly limited to 30-day outcomes and do not capture long-term patient reported outcomes (PROs) where the robotic may provide distinct advantages. We analyzed patients who underwent ventral hernia repair from January 2020-September 30, 2022 in the Michigan Surgical Quality Collaborative Core Optimization Hernia Registry (MSQC-COHR). Validated PROs included the Ventral Hernia Recurrence Inventory (VHRI), PROMIS Pain Intensity 3a (Pain 3a), and HerQLes quality of life measures. Survey weighting was employed to reduce non-response bias and balance respondents with the overall COHR population. Logistic regression was used to assess the relationship of operative approach with answering "Yes" to the 3 VHRI questions, reporting a worse than average Pain 3a score, and reporting a below median HerQLes score. Models accounted for patient, hernia, and operative characteristics. Our sample included 1583 patients undergoing hernia repair, of which 507 (32.0%) were robotic, 202 (12.8%) were laparoscopic, and 874 (55.2%) were open. Median follow up time was 1.3years (IQR 1.2-1.5). Patient characteristics were similar across approaches. Robotic repairs were more often performed electively, on larger hernias, and with mesh. After controlling for covariates, a robotic approach was associated with a lower predicted probability of reporting a bulge [19.5% (95% CI 15.7-23.2%)] than a laparoscopic approach [26.8% (95% CI 20.4-33.2%)], but was no different than an open approach [18.8% (95% CI 16.1-21.6%)]. No other differences in PROs were found by approach. We found a lower likelihood of reporting a bulge after robotic ventral hernia repair when compared with a laparoscopic approach, but no difference when compared with an open approach. No other differences in long-term PROs were found when comparing robotic to laparoscopic or open approaches.

"Ups and Downs, Joys and Sorrows" - Assessment and Clinical Relevance of Patient Priorities in an Interdisciplinary Parkinson's Disease Clinic.

Barriers to communication and inaccurate provider assumptions about patient priorities limit the delivery of comprehensive, high-quality, patient-centered care (PCC) to people with Parkinson's (PWP). This study aimed to analyze priorities of PWP using a qualitative, unstructured single-question survey and to test associations with validated quality of life (QOL) measures. During appointments at a subspecialty, interdisciplinary clinic, PWP (n=139) provided written responses to the prompt: "What is important for your care team to know about you?" Patient Health Questionnaire, Montreal Cognitive Assessment, and Hoehn and Yahr scales were obtained through retrospective chart review. Key qualitative themes were identified through grounded theory analysis, and associations with quantitative health measures were tested with correlation analyses. Common themes included participant health (eg, PD-related goals and comorbidities), non-illness identities (eg, family or community role), and the psychosocial impact of PD (eg, losing independence and uncertainty). Positive sentiments (n=73), such as motivation and optimism, were more common than negative sentiments (n=45), such as loss and fear. There was moderate concordance between worsened mental health and uncertainty (rho=0.206, p=0.02) and inverse concordance between worsened mobility and gratitude (rho=-0.174, p=0.04). The range of priorities that PWP want to share with their care team is more diverse than that of common provider assumptions, is correlated with clinical outcomes such as mental health and mobility, and may not be captured by existing QOL assessment tools. An open-ended, qualitative prompt should be incorporated into routine specialist care for PWP as a valuable QOL indicator.

Bidirectional association between frailty and quality of life within English longitudinal study of aging.

The relationship between quality of life (QoL) and frailty has previously been investigated cross-sectionally and longitudinally as unidirectional where QoL depends upon frailty and where frailty depends on QoL. Here a bidirectional relationship is examined. This work uses a latent curve model with structured residuals to address the bidirectional association between QoL and frailty in older English people considering within-person and group levels. The study measures frailty using a functional frailty measure and quality of life using CASP-12. The sample size is 17,529. There is a strong relationship between QoL (Quality of Life) and frailty, which is almost linear and inversely proportional over time. Although the cross-lagged coefficients from QoL to frailty and vice versa showed statistical significance, the impact was found to be minimal. The time between assessments (which are two years apart) and/or the few observations available per individual may have impacted the effect of this relationship. When accounting for gender, age, net wealth, and multimorbidity, some variations in the results were observed at the group level but not at the within-person level. The study provides empirical evidence that supports a bidirectional association between QoL and frailty in older individuals who reside at home. These results offer valuable insights for healthcare providers, as participants did not exhibit an advanced need for health services. Additionally, involving participants in evaluating and assessing these services enhances their effectiveness and overall benefit.

Development and Validation of a Pediatric Celiac Disease-Specific Quality of Life Measure.

Quality of life (QOL) is critical in screening and management of chronic medical conditions, including celiac disease (CD). This project aimed to develop a CD-specific pediatric QOL measure ("CDLIFE") with parallel self- and parent-report forms by generating items through concept elicitation interviews, iterative refinement using cognitive debriefing interviews, and evaluating its psychometric properties and validity. Concept elicitation interviews were conducted to develop items (nine youth ages 8-19 with CD; 10 parents of youth with CD), followed by cognitive interviews with additional stakeholders (three youth with CD, three parents, and eight clinicians), and item administration (parent/youth reports: n=103/102). Analyses included response frequencies, internal consistency reliability, exploratory factor analyses, and correlations with related measures (PROMIS, PEDSQL, and GFD-VAS). From concept elicitation interviews, 42 youth and 45 parent items were developed. Cognitive debriefing interviews yielded 36 refined items. Psychometric analyses identified 15 items to remove due to ceiling/floor effects, poor item-to-test correlations; youth-parent mismatch or conceptual mismatch. Total score internal consistency was high (alphas=0.89-0.90). A four-factor model solution had the best fit (Social Impact, External Support, Adaptive Vigilance, Eating Behaviors/Adjustment) with a fifth single-item domain (Financial Resources). The final CDLIFE (21 items) total scores correlated with most related measures in expected directions for parent and youth forms. The CDLIFE may facilitate insight into CD-specific QOL for youth ages 2-18 years, capturing important dimensions of physical and socioemotional health. Administering the CDLIFE will help identify and track families needing support.

Quality of Life Effects of Renal Artery Stenting Versus Medical Therapy for Atherosclerotic Renal-Artery Stenosis: Results from the Randomized CORAL Trial.

Renal-artery stenosis can be associated with difficult to control hypertension, although renal-artery stenting has not been shown to improve clinical outcomes. Alternative antihypertensive medications could potentially result in quality of life benefits with renal-artery stenting. We performed a pre-specified quality of life sub-study of the CORAL trial-multicenter, randomized, open-label trial of renal-artery stenting versus medical therapy in patients with atherosclerotic renal-artery stenosis. Longitudinal growth curve models were used to compare the Physical Symptoms Distress Index (PSDI), SF-36, and EQ-5D scores over time between treatment groups. We also sought to validate the approach of assessing quality of life in hypertension studies. Among 906 patients (mean age 69.2±9.1years, 49.7% men), symptom frequency and distress due to side effects from antihypertensive medications changed minimally over time, with no significant differences between treatment groups. There were also no clinically significant differences between treatment groups for the SF-36 and its subscales or the EQ-5D. In internal validation of the quality of life measures, the PSDI correlated well with number/type of antihypertensive medications, and generic health status measures correlated with late clinical events. In a large, multicenter, randomized clinical trial, we found no significant benefit of routine renal-artery stenting over medical management for the treatment of atherosclerotic renal-artery stenosis in terms of disease-specific or generic quality of life measures. As these quality of life measures are important to patients and are associated with medication compliance, future studies of antihypertensive treatments should consider including these quality of life measures as secondary outcomes. Trial registration: ClinicalTrials.gov: NCT00081731.

Pain in recessive dystrophic epidermolysis bullosa (RDEB): findings of the Prospective Epidermolysis Bullosa Longitudinal Evaluation Study (PEBLES)

BackgroundPain is common in the genetic skin fragility disorder epidermolysis bullosa (EB), from skin and mucosal injury and inflammation as well as extra-mucocutaneous sites. Individuals living with EB have identified pain as a priority for better treatments.ObjectivesThe Prospective EB Longitudinal Evaluation Study (PEBLES) is a prospective register study exploring the natural history of RDEB across all ages from birth to death. Here, we investigated the characteristics and treatment of pain in different RDEB subtypes.MethodsInformation was collected from individuals with different RDEB subtypes over an 8-year period. Data included visual analogue scale (VAS) ratings of background and procedural pain, its location, intensity and impact on sleep, as well as pain medication. Disease severity scores and quality of life measures were correlated to pain scores.ResultsSixty-one participants (13 children, 48 adults) completed a total of 361 reviews. Pain was common, experienced by 93% of participants at index review, with 80% suffering both background and procedural pain. Across all RDEB patients, the median VAS for background pain was 40 (out of 100) [interquartile range 20,60] and for those having regular dressing changes, median procedural pain was 52 [40,80]. Severe (RDEB-S) and pruriginosa (RDEB-Pru) groups had the greatest increase in procedural compared to background pain of 20 and 22 VAS points, respectively. Correlations between disease severity and quality of life impairment were observed across most groups, particularly RDEB-S. Over half of those studied experienced pain frequently or constantly, and in one third pain disturbed sleep at least 4 nights per week. Skin was the commonest source of pain in all subtypes except inversa RDEB where the mouth was the main site. Despite frequent and severe pain, one third of participants used no medication for pain and, in those that did, pain levels remained high suggesting ineffectiveness of current pain management approaches and a significant unmet need in RDEB.ConclusionThe frequency, severity, and impact of pain in all RDEB patients is significant, particularly in RDEB-S and RDEB-Pru. Our findings highlight that current RDEB pain management is poorly effective and that further research is needed to address this symptom.

Transcatheter Aortic Valve Implantation by Valve Type in Women With Small Annuli

Historically, women with aortic stenosis have experienced worse outcomes and inadequate recognition compared to men, being both underdiagnosed and undertreated, while also facing underrepresentation in clinical trials. To determine whether women with small aortic annuli undergoing transcatheter aortic valve replacement have better clinical and hemodynamic outcomes with a self-expanding valve (SEV) or balloon-expandable valve (BEV). The Small Annuli Randomized to Evolut or SAPIEN Trial (SMART) was a large-scale randomized clinical trial focusing on patients with small aortic annuli undergoing transcatheter aortic valve replacement, randomized to receive SEVs or BEVs and included 716 patients treated at 83 centers in Canada, Europe, Israel, and the US from April 2021 to October 2022. This prespecified secondary analysis reports clinical and hemodynamic findings for all 621 women enrolled in SMART. Data for this report were analyzed from February to April 2024. Transcatheter aortic valve replacement with an SEV or a BEV. The composite coprimary clinical end point comprised death, disabling stroke, or heart failure-related rehospitalization. The coprimary valve function end point was the incidence of bioprosthetic valve dysfunction, both assessed through 12 months. Secondary end points included the incidence of moderate or severe prosthesis-patient mismatch. A total of 621 women (mean [SD] age, 80.2 [6.2] years; 312 randomized to the SEV group and 309 to the BEV group) were included in the present analysis. At 12 months, there were no significant differences in the coprimary clinical end point between the SEV and BEV groups (9.4% vs 11.8%, absolute risk difference -2.3%; 95% CI -7.2 to 2.5, P = .35). However, SEV implantation was associated with less bioprosthetic valve dysfunction (8.4% vs 41.8%; absolute risk difference, -33.4%; 95% CI, -40.4 to -26.4; P < .001). SEV implantation resulted in lower aortic valve gradients and larger effective orifice areas at 30 days and 12 months and less mild or greater aortic regurgitation at 12 months compared to BEV implantation. Prosthesis-patient mismatch was significantly lower with SEVs, regardless of the definition used and adjustment for body mass index. Use of SEVs was associated with better quality of life outcomes as assessed by the Valve Academic Research Consortium-3 ordinal quality of life measure. Among women with severe symptomatic aortic stenosis and small aortic annuli undergoing transcatheter aortic valve replacement, the use of SEVs, compared to BEVs, resulted in similar clinical outcomes and a markedly reduced incidence of bioprosthetic valve dysfunction through 12 months, including a lower risk of prosthesis-patient mismatch and better 12-month quality of life. ClinicalTrials.gov Identifier: NCT04722250.