36-Item Short-Form General Health Research Articles

Hiatal Hernia Repair With Tension-Free Mesh or Crural Sutures Alone in Antireflux Surgery

Antireflux surgery is an effective treatment of gastroesophageal reflux disease (GERD), but the durability of concomitant hiatal hernia repair remains challenging. Previous research reported that the use of a mesh-reinforced, tension-free technique was associated with more dysphagia for solid foods after 3 years without reducing hiatal hernia recurrence rates compared with crural sutures alone, but the long-term effects of this technique have not been assessed. To assess the long-term anatomical and functional outcomes of using a mesh for hiatal hernia repair in patients with GERD. A double-blind, randomized clinical trial was performed at a single center (Ersta Hospital, Stockholm, Sweden) from January 11, 2006, to December 1, 2010. A total of 159 patients were recruited and randomly assigned. Data for the current analysis were collected from September 1, 2021, to March 31, 2022. All analyses were conducted with the intention-to-treat population. Closure of the diaphragmatic hiatus with crural sutures alone vs a tension-free technique using a nonabsorbable polytetrafluoroethylene mesh (Bard CruraSoft). The primary outcome was radiologically verified recurrent hiatal hernia after more than 10 years. Secondary outcomes were dysphagia scores (ranging from 1 to 4, with 1 indicating no episodes of dysphagia and 4 indicating more than 3 episodes of dysphagia per day) for solid and liquid foods, generic 36-Item Short Form Health Survey and disease-specific Gastrointestinal Symptom Rating Scale symptom assessment scores, proton pump inhibitor consumption, and reoperation rates. Intergroup comparisons of parametric data were performed using t tests; for nonparametric data, Mann-Whitney U, χ2, or Fisher exact tests were used. For intragroup comparisons vs the baseline at follow-up times, the Friedman test was used, and post hoc analysis was performed using Wilcoxon matched pairs. Of 145 available patients, follow-up data were obtained from 103 (response rate 71%; mean [SD] age at follow-up, 65 [11.3] years; 55 [53%] female), with 53 initially randomly assigned to mesh reinforcement, and 50 to crural suture alone. The mean (SD) follow-up time was 13 (1.1) years. The verified radiologic hiatal hernia recurrence rates were 11 of 29 (38%) in the mesh group vs 11 of 35 (31%) in the suture group (P = .61). However, 13 years postoperatively, mean (SD) dysphagia scores for solids remained significantly higher in the mesh group (mean [SD], 1.9 [0.7] vs 1.6 [0.9]; P = .01). Findings from this long-term follow-up of a randomized clinical trial suggest that tension-free crural repair with nonabsorbable mesh does not reduce the incidence of hiatal hernia recurrence 13 years postoperatively. This finding combined with maintained higher dysphagia scores does not support the routine use of tension-free polytetrafluoroethylene mesh closure in laparoscopic hiatal hernia repair for treatment of GERD. ClinicalTrials.gov Identifier: NCT05069493.

Psychometric study of the SF-36v2 in hereditary angioedema due to C1 inhibitor deficiency (C1-INH-HAE)

BackgroundThe generic 36-item Short-Form Health Survey (SF-36v2) has been used to assess health related quality of life in adult patients with hereditary angioedema due to C1-inhibitor deficiency (C1-INH-HAE) even though it has not yet been validated for use in this specific disease.ObjectiveThis study aims to validate the SF-36v2 for use in adult patients with C1-INH-HAE.ResultsThere was a very low item non-response rate (1–3.4%), with a high ceiling effect in 25/35 items and a low floor effect in 3/35 items. A moderate ceiling effect was observed in 5/8 dimensions of the SF-36v2, whereas no floor effect was noticed in any of the dimensions. Internal consistency was good to excellent with Cronbach's alpha coefficient ranging between 0.82 and 0.93 for the different dimensions. Construct validity was good: seven out of the 8 hypotheses defined on clinical criteria were confirmed, discriminant validity assessment showed significant differences among patients with different C1-INH-HAE severity, convergent validity showed a good correlation among the physical and mental component summaries of the SF-36v2 and the HAE-QoL total score (0.45 and 0.64 respectively, P < 0.001). Test–retest reliability was high with intraclass correlation coefficient varying from 0.758 to 0.962. The minimal clinically important difference was calculated by distribution methods and small differences in the domain scores and in the component summaries scores were shown to be meaningful. ConclusionsThe psychometric properties of the SF-36v2 show it can be a useful tool to assess HRQoL in adult patients with C1-INH-HAE, although with some content validity limitation.MethodsThe psychometric properties of the SF-36v2 were evaluated in an international setting based on responses from 290 adult C1-INH-HAE patients in 11 countries.

Wood smoke exposure affects lung aging, quality of life, and all-cause mortality in New Mexican smokers

BackgroundThe role of wood smoke (WS) exposure in the etiology of chronic obstructive pulmonary disease (COPD), lung cancer (LC), and mortality remains elusive in adults from countries with low ambient levels of combustion-emitted particulate matter. This study aims to delineate the impact of WS exposure on lung health and mortality in adults age 40 and older who ever smoked.MethodsWe assessed health impact of self-reported “ever WS exposure for over a year” in the Lovelace Smokers Cohort using both objective measures (i.e., lung function decline, LC incidence, and deaths) and two health related quality-of-life questionnaires (i.e., lung disease-specific St. George's Respiratory Questionnaire [SGRQ] and the generic 36-item short-form health survey).ResultsCompared to subjects without WS exposure, subjects with WS exposure had a more rapid decline of FEV1 (− 4.3 ml/s, P = 0.025) and FEV1/FVC ratio (− 0.093%, P = 0.015), but not of FVC (− 2.4 ml, P = 0.30). Age modified the impacts of WS exposure on lung function decline. WS exposure impaired all health domains with the increase in SGRQ scores exceeding the minimal clinically important difference. WS exposure increased hazard for incidence of LC and death of all-cause, cardiopulmonary diseases, and cancers by > 50% and shortened the lifespan by 3.5 year. We found no evidence for differential misclassification or confounding from socioeconomic status for the health effects of WS exposure.ConclusionsWe identified epidemiological evidence supporting WS exposure as an independent etiological factor for the development of COPD through accelerating lung function decline in an obstructive pattern. Time-to-event analyses of LC incidence and cancer-specific mortality provide human evidence supporting the carcinogenicity of WS exposure.

Associations between the Severity of Sarcopenia and Health-Related Quality of Life in Community-Dwelling Middle-Aged and Older Adults

(1) Background: The aim of this study was to analyze the associations between severity of sarcopenia and health-related quality of life (HRQoL) among community-dwelling middle-aged and older adults. (2) Methods: A cross-sectional study involving 304 older-adult participants was used to assess the severity of sarcopenia by measuring muscle strength (handgrip dynamometer), muscle mass (bioelectrical impedance analysis), and physical performance (Timed Up-and-Go test). The generic 36-item Short-Form Health Survey (SF-36) was used to evaluate HRQoL. Anxiety and depression (Hospital Anxiety and Depression Scale) as well as age were considered as possible confounders. Probable sarcopenia was determined by low muscle strength; confirmed sarcopenia was defined by the presence of both low muscle strength and muscle mass; and severe sarcopenia was defined by low muscle strength and mass along with poor physical performance. (3) Results: The linear regression analysis showed that the presence of probable sarcopenia was associated with the SF-36 domains physical role (adjusted R2 = 0.183), general health (adjusted R2 = 0.290), and social functioning (adjusted R2 = 0.299). As for the SF-36 mental (MCS) and physical (PCS) component summary scores, probable sarcopenia, as well as depression and anxiety, remained associated with MCS (adjusted R2 = 0.518), and these three variables, together with age, were linked to PCS (adjusted R2 = 0.340). (4) Conclusions: Probable sarcopenia, but not confirmed or severe sarcopenia, was independently associated with poor HRQoL. More precisely, it was related to PCS and MCS, as well as to the physical role, general health, and social functioning of SF-36 domains.

Health-Related Quality of Life Outcomes for Patients with Transfusion-Dependent Beta-Thalassemia Treated with Luspatercept in the Believe Trial

Health-Related Quality of Life Outcomes for Patients with Transfusion-Dependent Beta-Thalassemia Treated with Luspatercept in the Believe Trial

Ixekizumab Improves Functioning and Health in the Treatment of Radiographic Axial Spondyloarthritis: Week 52 Results from 2 Pivotal Studies.

This study evaluated the effect of ixekizumab (IXE) on self-reported functioning and health in patients with radiographic axial spondyloarthritis (r-axSpA) who were either biological disease-modifying antirheumatic drug (bDMARD)-naïve or failed at least 1 tumor necrosis factor inhibitor (TNFi). In 2 multicenter, randomized, double-blind, placebo-controlled, and active-controlled (bDMARD-naïve only) trials, patients with r-axSpA were randomly assigned to receive 80 mg of IXE [every 2 weeks (Q2W) or every 4 weeks (Q4W)], placebo (PBO), or adalimumab (ADA; bDMARD-naïve only). After 16 weeks, patients who received PBO or ADA were rerandomized to receive IXE (Q2W or Q4W) up to Week 52. Functioning and health were measured by the generic 36-item Short Form Health Survey (SF-36) and the disease-specific Assessment of Spondyloarthritis international Society Health Index (ASAS HI). Societal health utility was assessed by the 5-level EuroQol-5 Dimension (EQ-5D-5L). At Week 16, both doses of IXE in bDMARD-naïve and TNFi-experienced patients resulted in larger improvement in SF-36, ASAS HI, and EQ-5D-5L versus placebo. For SF-36, the largest improvements were seen for the domains of bodily pain, physical function, and role physical. A larger proportion of patients reaching improvement in ASAS HI ≥ 3 as well as an achievement of ASAS HI good health status was reported in patients treated with IXE. Improvements were maintained through Week 52. IXE significantly improved functioning and health as assessed by both generic and disease-specific measures, as well as societal health utility values in patients with r-axSpA, as measured by SF-36, ASAS HI, and EQ-5D-5L at Week 16, and improvements were sustained through 52 weeks.

Changes in Physical Performance and Their Association With Health-Related Quality of Life in a Mixed Nonischemic Cardiac Population That Participates in Rehabilitation.

Exercise-based cardiac rehabilitation improves physical performance and health-related quality of life (HRQoL). However, whether improvements in physical performance are associated with changes in HRQoL has not been adequately investigated in a nonischemic cardiac population. Patients who were ablated for atrial fibrillation, who underwent heart valve surgery or who were treated for infective endocarditis, and who participated in 1 of 3 randomized controlled rehabilitation trials were eligible for the current study. Change in physical performance and HRQoL were measured before and after a 12-wk exercise intervention. Physical performance was assessed using a cardiopulmonary exercise test, a 6-min walk test, and a sit-to-stand test. Health-related quality of life was assessed using the generic 36-Item Short Form Health Survey and the disease-specific HeartQoL questionnaire. Spearman correlation coefficient (ρ) and linear regressions quantified the association between changes in physical outcome measures and changes in HRQoL. A total of 344 patients were included (mean age: 60.8 ± 11.6 yr and 77% males). Associations between changes in physical outcome measures and HRQoL ranged from very weak to weak (ρ = -0.056 to 0.228). The observed associations were more dominant within physical dimensions of the HRQoL compared with mental or emotional dimensions. After adjusting for sex, age, and diagnosis, changes in physical performance explained no more than 20% of the variation in the HRQoL. The findings show that the positive improvement in HRQoL from exercise-based cardiac rehabilitation cannot simply be explained by an improvement in physical performance.

Psychometric Properties of the Spanish Version of the Sarcopenia and Quality of Life, a Quality of Life Questionnaire Specific for Sarcopenia.

The Sarcopenia and Quality of Life questionnaire (SarQol®) is a self-administered multidimensional sarcopenia-specific tool designed for community-dwelling subjects aged 65years and older. The purpose of the present study was to evaluate the psychometric properties of the Spanish version of the SarQoL®. A total of 252 participants aged ≥ 65years voluntarily participated in this cross-sectional study. Handgrip strength and bioelectrical impedance analysis were used for sarcopenia screening. Discriminative power, internal consistency, test-retest reliability, and floor and ceiling effects were analyzed. The generic 36-item Short-Form Health Survey (SF-36), the European Quality of Life 5-Dimension-3 Level (EQ-5D-3L), and the Hospital Anxiety and Depression Scale (HADS) were also used for convergent and divergent validity. Significant differences between sarcopenic (n = 66) and non-sarcopenic participants were observed for SarQoL® total score (p = 0.008) and for all domains except D2-locomotion. A high internal consistency of SarQoL® total score (Cronbach's alpha = 0.904) was found, and significant domain-to-total score correlations were obtained (all p < .001). Test-retest data showed excellent reliability for SarQoL® total score (ICC = 0.99; 95%CI 0.98-0.99) and in all dimensions, except for D6-leisure and D7-fears activities (substantial). No floor and ceiling effects were observed for SarQoL® total score. SarQoL® total score showed good and acceptable correlations(p < 0.001) with the selected domains of the SF-36 and EQ-5D-3L which have similar dimensions (convergent validity). Low and non-significant correlations existed with anxiety, depression, and EQ-5D-3L self-care and pain/discomfort domains (divergent validity). The Spanish SarQoL® shows satisfactory general psychometric properties in Spanish-speaking older adults from Spain and is able to discriminate between older adults with and without sarcopenia.

Predictors of health related-quality of life among elderly with disabilities.

There have been no previous studies of health-related quality of life (HRQOL) among adults aged 65 years and older with disabilities in Serbia. The aim of study was to identify predictors of HRQOL in the context of sociodemographic characteristics, disability aetiology, comorbid diseases, indices of comorbidities, realization of social rights, and domestic violence. The cross-sectional study involved 275 consecutive elderly outpatients with disabilities. They were recruited by general practitioners at Primary Health Centers in Belgrade, Serbia, from March to May 2015. Data were acquired through face-to-face interviews and general practitioners' charts, while the generic 36-item Short Form Health Survey was used to assess HRQOL. In statistical analysis, Student's t-test, Z-test, Spearman's correlation test, and both univariate and multivariate linear regression were performed. Multivariate analysis revealed that a higher Functional Comorbidity Index (β = -0.194, P < 0.01) and not asking for realization of right to assistance and care financial benefits (β = -0.142, P < 0.05) were predictors of a lower scores Mental Composite Score (F = 9.262; P < 0.001). Not asking for realization of right to assistance and care financial benefits (β = -0.187, P < 0.01), congestive heart failure (β = -0.123, P < 0.05), and stroke (β = -0.120, P < 0.05) were predictors of a lower Physical Composite Score (F = 7.169, P < 0.001). This study provides valuable data for better understanding the underlying factors associated with the HRQOL of elderly persons with disabilities, and currently, these are the only available data of their kind in Serbia. National authorities could identify predictors of HRQOL as a basic starting point for improving the social welfare and health-care systems. Better prevention and management of clinical factors, increased access to social services, and enhanced delivery of social services will improve the ageing process and HRQOL of this vulnerable population.

Health‐related quality of life as a predictor of recurrent falling in Parkinson's disease: 1‐year follow‐up study

The aim of this study was to assess whether various domains related to health-related quality of life could be predictive of recurrent falls among persons with Parkinson's disease (PD) during a 1-year follow-up study. A total of 120 consecutive persons with PD who had denied falling in past 6 months were recruited at regular check-ups at the Department of Movement Disorders, Neurology Clinic, Clinical Center of Serbia in Belgrade, from 15 August 2011 to 15 December 2012. At baseline, study participants were clinically assessed. Health-related quality of life was evaluated with the generic 36-item Short Form Health Survey. Participants were prospectively followed for 1 year, and occurrence of falls was registered. The median age of subjects was 60.0 years, with a median disease duration of 4.0 years. Of 120 persons with PD, 42 (35%) experienced falls during the 12-month study period, including 23 (19.2%) who fell repeatedly. After adjustment for gender, age, PD duration, levodopa dosage, Hoehn and Yahr stage, Unified Parkinson's Disease Rating Scale I-IV, Hamilton Depression Rating Scale, and Hamilton Anxiety Rating Scales, we identified the 36-item Short Form Health Survey domains of role physical (P = 0.033) and vitality (P = 0.019) as being associated with recurrent falls of persons with PD within the 1-year follow-up period. Baseline 36-item Short Form Health Survey scores regarding both the physical and mental components of overall health may be related to recurrent falling among persons with PD. These HRQoL domains could be considered as potential markers for persons with PD who are prone to recurrent falls.

Health-related quality of life and emotional well-being in parents of children with epilepsy referred for presurgical evaluation in Sweden.

The purpose of this study was to assess and compare health-related quality of life (HRQoL) and emotional well-being in mothers and fathers of children with drug-resistant epilepsy, referred for presurgical evaluation in Sweden. Mothers (n=117) and fathers (n=102) of 122 children (0-18 years) completed the generic 36-item Short Form Health Survey (SF-36) and the Hospital Anxiety and Depression Scale (HADS). Mothers' and fathers' SF-36 scores were compared with age-adjusted Swedish population values using the independent t-tests. Differences in the proportions of mothers vs. fathers classified as 'noncases' or 'possible/probable' clinical cases of anxiety (HADS-A) and depression (HADS-D), respectively, were assessed with the chi-square test. Parents' HADS scores were also compared using independent t-tests. Mothers had significantly lower scores compared with norms on 6 of the 8 SF-36 domains (p<0.01), while fathers had significantly lower scores on 4 of the domains (p<0.01). Mothers had significantly lower scores than fathers on 4 of the SF-36 domains (p<0.05). Significantly more mothers than fathers scored below the population mean for the SF-36 Mental Component Summary score. A significantly larger proportion of mothers than fathers had 'possible/probable' anxiety (52% vs. 38%) but not depression (30% vs. 22%). Mothers had significantly worse scores than fathers on HADS-A (p<0.01) but not on HADS-D. Mothers and fathers of children with drug-resistant epilepsy have diminished HRQoL compared with population norms. Symptoms of anxiety appear to be more common than symptoms of depression. Mothers experienced higher levels of anxiety, but not depression, than fathers and scored lower than fathers on vitality, mental health, and Mental Component Summary of the SF-36. There is a need to identify contributory factors and interventions to ameliorate these difficulties.

Health‐related quality of life, mood, and patient satisfaction after epilepsy surgery in Sweden—A prospective controlled observational study

ObjectiveTo evaluate health-related quality of life (HRQOL), mood, and patient satisfaction in epilepsy surgery candidates before and 2 years after epilepsy surgery or presurgical investigation.MethodsIn this prospective study of 141 patients, 96 underwent surgery and 45 did not. Questionnaires at baseline and at 2-year follow-up included the generic 36-item Short Form Health Survey (SF-36), the Hospital Anxiety and Depression scale (HAD), and operated patients answered patient satisfaction questions. SF-36 scores were compared with scores from a matched sample from the Swedish norm population. Numbers were calculated of patients achieving a minimum important change (MIC) in the SF-36 Physical Composite Summary (PCS) and Mental Composite Summary (MCS).ResultsAt baseline, patients had significantly lower values than the norm on all SF-36 domains. At follow-up, operated patients were divided into seizure-free (International League Against Epilepsy [ILAE] class 1 and 2, n = 53) or with continued seizures (n = 43). No differences in baseline HAD or SF-36 values were found between these groups. Seizure-free patients reached the same levels as the norm in all SF-36 domains except Social Function. Operated patients with continued seizures and nonoperated patients had unchanged scores. Fifty-one percent of seizure-free patients had an improvement reaching MIC for PCS and 45% for MCS. Corresponding results for patients with continued seizures were 28% in PCS and 28% in MCS, for nonoperated 33% in PCS and 29% in MCS. HAD anxiety scores improved significantly in only the seizure-free patients. Of all operated patients, 80% were satisfied with having had surgery and 86% considered that they had benefited, whereas 20% thought that surgery caused some harm.SignificanceIn patients who were seizure-free after epilepsy surgery HRQOL normalized and anxiety decreased. Operated patients overwhelmingly considered epilepsy surgery to be beneficial. Nonetheless, only about half of the seizure-free patients achieved important HRQOL improvements, suggesting that seizure freedom does not in and of itself guarantee improved patient well-being.

Health-Related Quality of Life Profiles Among Family Caregivers of Patients With Schizophrenia

This cross-sectional study aims to determine and compare health-related quality of life profiles of schizophrenia family caregivers on the basis of their sociodemographic characteristics. Thirty outpatient family caregivers completed the generic 36-Item Short Form Health Survey instrument (male = 53.5%; mean age = 51 years; married = 76.7%). The highest mean score was reported for social functioning while role limitation-emotional was rated the worst. Significantly better health-related quality of life profiles were demonstrated by caregivers who were male, younger than 50 years, adequately educated, employed, and without health problems and were receiving monthly income. Understanding of on health-related quality of life matters for family caregivers is crucial to improve the quality of care for schizophrenia patients.

Validation Assessment of the Chinese (Taiwan) Version of the Gastrointestinal Quality of Life Index for Patients with Symptomatic Gallstone Disease

Symptomatic gallstone is one of the most common diseases in Taiwan. The aim of this study was to develop a Mandarin Chinese outcomes measure for the assessment on quality of life among gallstone patients. The Gastrointestinal Quality of Life Index (GIQLI) is a valid, disease-specific measure for the evaluation of health status and treatment effectiveness for adults with chronic gastrointestinal condition. The GIQLI was translated into Mandarin Chinese using a parallel model. The Chinese (Taiwan) version of the GIQLI (CGIQLI) was administered to 102 patients with symptomatic gallstone disease in a prospective manner; the CGIQLI then was validated according to established criteria for reliability, validity, and longitudinal sensitivity. The CGIQLI demonstrates good test-retest reliability (r = 0.92, P = 0.001) and internal consistency (Cronbach's alpha = 0.92). The CGIQLI significantly correlates with the Mandarin Chinese (Taiwan) version of the generic 36-Item Short-Form Health Survey (SF-36). The standardized response mean for the CGIQLI total score is 0.96, indicating excellent sensitivity to clinical change in the study group. This validation study demonstrated that the performance characteristics of the CGIQLI are equivalent to the English version, the GIQLI. This study demonstrates that the CGIQLI is a valid tool to evaluate adults with chronic gastrointestinal problems among the Chinese-speaking population.

Validation of outcomes survey for adults with chronic suppurative otitis media.

Currently, there is no valid, disease-specific outcomes measure to evaluate health impact and treatment effectiveness for patients with chronic suppurative otitis media (CSOM). The Chronic Ear Survey (CES) is a new, disease-specific outcomes measure for CSOM that was administered in a prospective manner to 91 patients with CSOM. It was then validated according to established criteria for reliability, validity, and sensitivity to clinical change by correlation with objective data and self-assessment questionnaires such as the Hearing Handicap Inventory for Adults (HHIA) and the generic 36-Item Short-Form Health Survey (SF-36). Significant correlations between subscale scores of the CES and audiometric data and between subscale scores of the HHIA and SF-36 were found. The standardized response mean for the CES total score was 0.42, indicating moderate sensitivity to clinical change. Overall, results demonstrated that the CES is a reliable and valid instrument for investigation of health status and health-related quality-of-life outcomes.