SF-36 Data Research Articles

Quality of life of patients with neurofibromatosis 1-Physical disability does not necessarily result in poor mental health.

Neurofibromatosis 1 (NF1) is a chronic neurocutaneous disease known to profoundly affect quality of life (QoL). We have performed an analysis of disease severity, mental and physical QoL and compare the different subclasses among patients with neurofibromatosis 1 (NF1). We conducted a prospective analysis of 89 NF1 patients between January 2016 and March 2018. Data sourced from local records including demographic information, employment status, education level, and marital status. All patients completed 36-Item Short Form Health Survey (SF-36) and additionally the numerical pain rating scale (NPS). Patients were stratified based on severity of NF1, visibility and disease severity. Among 89 patients, severity was classified as grade 4 was identified in 42 (47.2%), moderate in 17 (19.1%), mild in 23 (25.8%) and minimal in 7 (7.9%) cases. According to visibility scale, severe grade 3 was found in 28 (31.5%), moderate grade 2 in 26 (29.2%) and mild grade in 35 (39.3%) cases. SF-36 data, except for pain, showed significantly lower values, if compared to the standard German population (P < 0.001, physical component summary P = 0.045). Sex, marital status and education level did not significantly influence results. Employment was significantly associated with better mental and physical status (P = 0.028 and P = 0.01 respectively) and age >40 was linked to lower physical (P = 0.027) but not mental component scores (P = 0.362). The numerical pain rating scale indicated pain levels of 7-10 in 9 cases (10,1%), 5-6 in 10 patients (11.2%), 1-4 in 26 patients (29.2%) and no pain in 44 cases (49.4%). Physical component scores significantly differed across different NPS grades (P < 0.001) but not in mental component scores (P = 0.06). Finally, no significant differences were found in mental component scores across severity or visibility grades. Severity and visibility grades of patients with NF1 may not necessarily result in poor mental health. Symptomatic treatment should be considered even for severely disabled patients as they may have comparable QoL to less severely affected patients with NF1. Employment was linked to better quality of life outcomes in our findings.

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.

Impact of COVID-19 on quality of life in survivors with pulmonary sequelae

SARS-CoV-2 respiratory infection is still under study today, mainly because of its long-term effects. This study aims to analyse health status and health-related quality of life (HRQoL) in survivors of coronavirus pneumonia (COVID-19) who have developed pulmonary sequelae. Prospective observational study of patients diagnosed with COVID-19 pneumonia between February and May 2020. Reviews were conducted at 3 and 12 months after hospital discharge. HRQoL was assessed by administration of the SF-36 questionnaire and data related to medical records and physical examination were also collected. In addition, chest X-ray, computed tomography and pulmonary function test were included as additional tests. 305 patients were admitted for COVID-19 pneumonia of which 130 (42.6%) completed follow-up. The mean age of the enrolled group was 55.9 ± 15.9 years. The most prevalent persistent symptoms were dyspnea (37.3%) and asthenia (36.9%). Pulmonary sequelae were detected in 20.8% of participants. The most frequent alteration was ground ground glass opacities (GGO) (88.9%), with mild extension. Fibrotic changes were found in only 2% of cases. When comparing the two groups, at 3 and 12 months of evolution, lower scores in the vitality (VT) and mental health (MH) domains were found only in the group without sequelae. Days of hospitalisation and Charlson index acted as influential factors on HRQoL. Minimal or mild pulmonary sequelae of SARS-CoV-2 do not cause further deterioration of HRQoL. Repeated medical care and pulmonary rehabilitation are effective tools to improve HRQoL.

Health-related quality of life after 12 months post discharge in patients hospitalised with COVID-19-related severe acute respiratory infection (SARI): a prospective analysis of SF-36 data and correlation with retrospective admission data on age, disease severity, and frailty

Long-term outcome and ‘health-related quality of life’ (HRQoL) following hospitalisation for COVID-19-related severe acute respiratory infection (SARI) is limited.ObjectiveTo assess the impact of HRQoL in patients hospitalised with COVID-19-related SARI...

P1050 A cost-utility analysis of ferric derisomaltose versus ferric carboxymaltose in patients with inflammatory bowel disease and iron deficiency anaemia in Finland

Abstract Background Anaemia is a common extraintestinal manifestation of inflammatory bowel disease (IBD), with iron deficiency being the most common cause. Iron deficiency anaemia (IDA) can be treated with oral iron, but where oral administration is contraindicated, not tolerated, or proves to be ineffective, intravenous (IV) iron is the preferred treatment option, facilitating rapid iron replenishment. Ferric derisomaltose (FDI) and ferric carboxymaltose (FCM) are two high-dose, rapid-infusion, IV iron formulations that have recently been compared in three head-to-head randomized controlled trials (RCTs), with FCM administration resulting in significantly higher hypophosphataemia incidence versus FDI, and phosphate monitoring after repeat FCM infusions is now recommended in the FCM product information (PI). Between 2000 and 2020, Finland has seen the average incidence of IBD increase by 2.4% annually, accompanied by a commensurate increase in sequelae such as IDA. The objective of the present study was therefore to evaluate the cost-utility of FDI versus FCM in patients with IBD and IDA in Finland. Methods A published patient-level simulation model was used to evaluate the cost-utility of FDI versus FCM in Finland. The model captured quality of life differences based on SF-36 data from the PHOSPHARE-IBD RCT and differences in the number of FDI and FCM infusions required. A Finnish societal perspective was adopted and the analysis was conducted over a five-year time horizon. Unit costs were obtained from publicly available Finnish sources. Costs were reported in 2022 Euros and a discount rate of 3% per annum was applied to future costs and effects. Results Over the five-year time horizon, patients received 3.95 courses of iron treatment on average, requiring 1.63 fewer infusions of FDI than FCM (5.57 versus 7.20). This resulted in iron procurement and administration cost savings of EUR 471 with FDI versus FCM (EUR 2,286 versus EUR 2,757). Differences in health-related quality of life and the number of IV iron infusions resulted in an increase of 0.076 quality-adjusted life years with FDI versus FCM. Further cost savings of EUR 273 over five years were also realised with FDI versus FCM, driven by reduced need for phosphate testing (saving EUR 90) and reduced travel and productivity loss (saving EUR 183). Total cost savings were EUR 745 (Figure) and FDI was therefore the dominant intervention. Conclusion Relative to FCM, FDI resulted in improvements in quality-adjusted life expectancy in Finnish patients with IBD and IDA. FDI also resulted in cost savings, arising from reduced infusion frequency, phosphate monitoring, patient travel, and productivity loss. FDI therefore represents the dominant choice of IV iron in Finnish patients with IBD and IDA.

MP48-11 A SYSTEMATIC REVIEW AND META-ANALYSIS OF HEALTH-RELATED QUALITY OF LIFE AFTER GENDER-AFFIRMING PELVIC SURGERY IN TRANSGENDER PATIENTS

You have accessJournal of UrologyCME1 Apr 2023MP48-11 A SYSTEMATIC REVIEW AND META-ANALYSIS OF HEALTH-RELATED QUALITY OF LIFE AFTER GENDER-AFFIRMING PELVIC SURGERY IN TRANSGENDER PATIENTS Kevin Hakimi, Cathrine Keiner, Kyle Okamuro, Isabella Dolendo, and Jennifer Anger Kevin HakimiKevin Hakimi More articles by this author , Cathrine KeinerCathrine Keiner More articles by this author , Kyle OkamuroKyle Okamuro More articles by this author , Isabella DolendoIsabella Dolendo More articles by this author , and Jennifer AngerJennifer Anger More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003294.11AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: With new legislation put forth targeting the ability of transgender individuals to seek gender-affirming care, we sought to explore outcomes of bottom surgery (phalloplasty, metoidioplasty, vaginoplasty, vulvoplasty) and its effect on health-related quality of life. METHODS: Utilizing Meta-analysis of Observational Studies in Epidemiology (MOOSE) criteria, we performed a search of major biomedical databases for all relevant literature published from 1995 to 2021. Inclusion criteria were original research articles, studies of transgender patients receiving pelvic gender affirming surgery, and use of the SF-36 survey. We excluded case reports, analyses of clinical outcomes following non-pelvic gender-affirming surgery, or nonsystematic review articles. Following this, data were pooled where appropriate. Data was compiled using a comprehensive meta-analysis software (Revman). RESULTS: Our literature search identified 56 titles and 7 full articles that were included in the final review. Three studies provided SF-36 data scores including the general population and transgender patients without bottom surgery. Our analysis of 11,186 patients showed SF-36 scores were significantly higher in the general population in comparison to transgender patients without a history of gender-affirming surgery [0.25 (CI 0.17, 0.33), p<0.001). Seven studies provided SF-36 data scores including the general population and transgender patients after bottom surgery, with our analysis of 16,450 patients showing no significant difference in SF-36 scores between the general population and transgender patients post gender-affirming pelvic surgery [0.02 (CI -0.05, 0.09; p=0.55]. Lastly, of these studies, four provided SF-36 data on transgender patients before and after gender-affirming pelvic surgery. Our meta-analysis of 677 participants showed that bottom surgery resulted in significant improvements in overall SF-26 scores [-0.39 (CI -0.51, -0.27); p<0.001]. CONCLUSIONS: Gender-affirming surgery was associated with significant improvements in mental and physical health outcomes. Our meta-analysis supports the role of bottom surgery in improving health-related quality of life back to normal range. Source of Funding: UC San Diego School of Medicine Research Award © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e659 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Kevin Hakimi More articles by this author Cathrine Keiner More articles by this author Kyle Okamuro More articles by this author Isabella Dolendo More articles by this author Jennifer Anger More articles by this author Expand All Advertisement PDF downloadLoading ...

Treatment of Functional Dyspepsia in Outpatients after COVID-19 Infection

Aim: to compare the efficacy of different therapeutic regimens for managing functional dyspepsia in outpatients after COVID-19 infection.Materials and methods. 42 post-COVID-19 outpatients (age: 26–47 years) diagnosed with functional dyspepsia (FD) according to the Rome IV Criteria were enrolled in two parallel groups. All patients were divided in 2 groups by randomization: Group 1 received omeprazole at a dose of 80 mg/day, Group 2 received a combination of omeprazole and Kolofort® (a combined action drug product containing technologically processed antibodies to S100, TNF-alpha, and histamine) at a dose of 80 mg/day. At baseline and after treatment, a 10-point VAS was used to measure symptoms and an SF-36 questionnaire to evaluate the quality of life.Results. By Day 28 of the treatment, the intensity of epigastric pain (VAS score) in the group receiving proton-pump inhibitor (PPI) + Kolofort® was significantly lower. In both groups, fully resolved dyspeptic syndrome was observed in up to 90 % of patients, without significant differences (p &lt; 0.06). According to the SF-36 data, a combination treatment resulted in higher scores (pain and general health subscales) as compared to the PPI alone.Conclusion. Kolofort® relieves symptoms and improves the quality of life when added to the treatment regimen against functional dyspepsia in post-COVID-19 patients.

Long-Term Patient-Reported Outcomes Following Treatment with betibeglogene autotemcel in Patients with Transfusion-Dependent β-Thalassemia

Introduction: Patients (pts) with transfusion-dependent β-thalassemia (TDT) have increased morbidity and mortality and reduced quality of life (QoL) compared with the general population owing to the mental, physical, and time demands of chronic transfusions and iron chelation. Autologous gene therapy with betibeglogene autotemcel (beti-cel) therapy uses a modified β-globin gene that establishes stable production of functional adult hemoglobin (Hb), thus allowing for transfusion independence (TI). Pts with TDT were treated with beti-cel in 2 completed phase 1/2 studies (HGB-204, HGB-205) and 2 ongoing phase 3 studies as of Aug 2021 (HGB-207, HGB-212). After 2 years of follow-up, pts could enroll in a long-term follow-up study (LTF-303 [NCT02633943]) for up to an additional 13 years. QoL improvement in the 1-2 years post beti-cel treatment was previously described. Here, we evaluate long term (3 years post-treatment) patient reported outcomes after beti-cel treatment in pts with TDT enrolled in LTF-303. Methods: Pts with TDT underwent hematopoietic stem progenitor cell collection followed by myeloablative busulfan conditioning and beti-cel infusion. TI is defined as weighted average Hb ≥9 g/dL without packed red blood cell transfusions for ≥12 months. Generic health related QoL (HRQoL) over time was assessed using the Pediatric Quality of Life Inventory (PedsQL; range, 0-100) for pediatric and adolescent pts (<18 years old [YO]). Short Form-36 Health Survey Physical Component Summary and Mental Component Summary (SF-36 PCS and MCS, respectively; range 0-100), and the EuroQol (EQ-5D-3L) visual analog scale (VAS; range 0-100) composite index score (range 0-1) for adult (≥18 YO) pts. HRQoL was assessed at baseline (BL), Months (M) 6, 12, 18, 24 (in the parent HGB studies), and M 36, 48, and 60 (in LTF-303) after beti-cel infusion. Pts were excluded from HRQoL analyses if BL or M36 HRQoL assessment was missing as of data cut (Aug 2021). Higher scores indicated improvement in HRQoL. A bespoke questionnaire assessing β-thalassemia and pt-centric aspects of daily living (i.e., ability to work or attend school, physical activity, and perceived benefit from treatment) was completed at M 36. Results: As of August 18, 2021, 57 pts were enrolled in LTF-303 (phase 1/2: 22 pts; phase 3: 35 pts), of which 26 (45.6%) were pediatric / adolescent pts and 31 (54.4%) were adult pts. Among pts <18 YO with PedsQL data who achieved TI, the mean (standard error (SE)) PedsQL total score (population norm = 80.9) increased from 77.4 (3.4) at BL (n=19) to 92.1 (4.2) at M 36 (n=4). Among adult pts with SF-36 data who achieved TI, the mean (SE) SF-36 PCS and MCS scores (US general population norm = 50) increased from 53.8 (1.4) and 50.9 (1.7), respectively, at BL (n=12) to 55.7 (1.7) and 56.3 (1.4) at M 36 (n=9), respectively. The mean (SE) EQ-5D-3L Composite Index and VAS scores increased from 0.92 (0.04) and 85.2 (3.0), respectively, at BL (n=12), to 0.95 (0.03) and 91.4 (2.2) at M 36 (n=9) (Table 1). Data from the M 36 testimonial questionnaire (Figure 1) showed the ability to seek employment or be employed, increased from 68.8% (11/16) of pts at BL to 93.8% (15/16) at M 36. There was a reduction in school absences at M 36 (44.4% [4/9] missing school) compared with BL (83.3% [15/18] missing school). 50% (10/20) of pts still required management of disease symptoms at M 36. 80% (16/20) of pts reported improvement in physical activity at M 36. 100% (19/19) of pts reported an overall benefit from undergoing treatment with beti-cel. Conclusions: Published data shows beti-cel is potentially curative in pts with TDT, defined as having TI with normal or near-normal Hb. It was previously shown that with high-range QoL at BL, QoL improved at 1-2 years post-beti-cel. The updated data indicates durability of QoL improvement through year 3. A trend towards a positive impact on employment, school attendance, physical activity, and other aspects of life is also observed. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Physical Resilience Phenotype Trajectories in Incident Hemodialysis: Characterization and Mortality Risk Assessment

IntroductionAlthough life-saving, the physiologic stress of hemodialysis initiation contributes to physical impairment in some patients. Mortality risk assessment following hemodialysis initiation is underdeveloped and does not account for change over time. Measures of physical resilience, the ability of a physiologic state to overcome physiologic stressors, may help identify patients at higher mortality risk and inform clinical management.MethodsWe created 3 resilience categories (improving, stable, and declining) for trajectories of 4 phenotypes (physical function [PF], mental health [MH], vitality [VT], and general health [GH]) using SF-36 data collected the first year after hemodialysis initiation in the Choices for Healthy Outcomes in Caring for ESKD (CHOICE) study on 394 adults aged more than 55 years. Using mixed effects and Cox proportional hazard modeling, we assessed mortality following the first year on dialysis by resilience categories for each phenotype, adjusting for baseline phenotype and other confounders defined a priori over 4 years average follow-up.ResultsBased on global Wald tests, statistically significant associations of PF (P = 0.03) and VT (P = 0.0004) resilience categories with mortality were found independent of covariates. Declining PF trajectory was associated with higher mortality risk (hazard ratio [HR] = 1.32; 95% confidence interval [CI], 1.05–1.66), whereas improving VT trajectory was associated with lower mortality risk (HR= 0.73; 95% CI, 0.53 to 1.00), each as compared to stable trajectory.ConclusionDecreased resilience in PF and VT was independently associated with mortality. Phenotypic trajectories provide added value to baseline markers and patient characteristics when evaluating mortality. Hence, resilience measures hold promise for targeting population health interventions to the highest risk patients.

Stability of SF-36 profiles between 2007 and 2016: A study of 27,302 patients surgically treated for lumbar spine diseases

BackgroundPrevious studies have shown that patients with different lumbar spine diseases report different SF-36 profiles, but data on the stability of the SF-36 profiles are limited. The primary aim of the current study was to evaluate the stability of the SF-36 profile for lumbar spine diseases.MethodsPatients, surgically treated between 2007 and 2016 for three lumbar spine diseases, lumbar spinal stenosis (LSS) with degenerative spondylolisthesis (DS), LSS without DS, and lumbar disk herniations (LDH), were identified in the Swedish spine register. Preoperative and 1 year postoperative SF-36 data for a total of 27,302 procedures were available for analysis. The stability of the SF-36 profiles over the 10-year period was evaluated using graphical exploration, linear regression, difference in means, and 95% confidence intervals. The responsiveness of the SF-36 domains to surgical treatment was evaluated using the standardized response mean (SRM).ResultsLSS and LDH have different SF-36 profiles. LSS with DS and LSS without DS have similar SF-36 profiles. The preoperative and the 1 year postoperative SF-36 profiles were stable from 2007 to 2016 for all three diagnoses. There were no major changes in the effect size of change (SRM) during the study period for all three diagnoses. For LSS with DS, the number of fusions peaked in 2010 and then decreased. The postoperative SF-36 profiles for LSS with DS were unaffected by changes in surgical treatment trends.ConclusionsPatients with lumbar spinal stenosis and lumbar disk herniations have different SF-36 profiles. Concomitant degenerative spondylolisthesis had no impact on the SF-36 profile of lumbar spinal stenosis. Adding fusion to the decompression did not alter the postoperative SF-36 profile of lumbar spinal stenosis. The SF-36 health profiles are stable from a 10 years perspective.

Effectiveness and cost-effectiveness of a people-centred care model for community-living older people versus usual care ─ A randomised controlled trial.

There is a need for effective and cost-effective interprofessional care models that support older people to maintain their quality of life (QoL) and physical performance to live longer independently in their own homes. The objectives were to evaluate effectiveness, QoL and physical performance, and cost-utility of a people-centred care model (PCCM), including the contribution of clinically trained pharmacists, compared with that of usual care in primary care. A randomised controlled trial (RCT) with a two-year follow-up was conducted. The participants were multimorbid community-living older people, aged ≥75 years. The intervention comprised an at-home patient interview, health review, pharmacist-led clinical medication review, an interprofessional team meeting, and nurse-led care coordination and health support. At the baseline and at the 1-year and 2-year follow-ups, QoL (SF-36, 36-Item Short-Form Health Survey) and physical performance (SPPB, Short Performance Physical Battery) were measured. Additionally, a physical dimension component summary in the SF-36 was calculated. The SF-36 data were transformed into SF-6D scores to calculate quality-adjusted life-years (QALYs). Healthcare resource use were collected and transformed into costs. A healthcare payer perspective was adopted. Incremental cost-effectiveness ratio (ICER) was calculated, and one-way sensitivity analysis was performed. No statistically or clinically significant differences were observed between the usual care (n=126) and intervention group (n=151) patients in their QoL; at the 2-year follow-up the mean difference was -0.02, (95% CI -0.07; 0.04,p=0.56). While the mean difference between the groups in physical performance at the 2-year follow-up was -1.02, (-1.94;-0.10,p=0.03), between the physical component summary scores it was -7.3, (-15.2; 0.6,p=0.07). The ICER was -73 638€/QALY, hence, the developed PCCM dominated usual care, since it was more effective and less costly. The cost-utility analysis showed that the PCCM including pharmacist-led medication review dominated usual care. However, it had no effect on QoL and the effect towards physical performance remained unclear.

Association of Music Interventions With Health-Related Quality of Life

Increasing evidence supports the ability of music to broadly promote well-being and health-related quality of life (HRQOL). However, the magnitude of music's positive association with HRQOL is still unclear, particularly relative to established interventions, limiting inclusion of music interventions in health policy and care. To synthesize results of studies investigating outcomes of music interventions in terms of HRQOL, as assessed by the 36- and 12-Item Health Survey Short Forms (SF-36 and SF-12). MEDLINE, Embase, Web of Science, PsycINFO, ClinicalTrials.gov, and International Clinical Trials Registry Platform (searched July 30, 2021, with no restrictions). Inclusion criteria were randomized and single-group studies of music interventions reporting SF-36 data at time points before and after the intervention. Observational studies were excluded. Studies were reviewed independently by 2 authors. Data were independently extracted and appraised using GRADE criteria (Grading of Recommendations, Assessment, Development, and Evaluations) by multiple authors. Inverse-variance random-effects meta-analyses quantified changes in SF-36 mental and physical component summary (respectively, MCS and PCS) scores from preintervention to postintervention and vs common control groups. SF-36 or SF-12 MCS and PCS scores, defined a priori. Analyses included 779 participants from 26 studies (mean [SD] age, 60 [11] years). Music interventions (music listening, 10 studies; music therapy, 7 studies; singing, 8 studies; gospel music, 1 study) were associated with significant improvements in MCS scores (total mean difference, 2.95 points; 95% CI, 1.39-4.51 points; P < .001) and PCS scores (total mean difference, 1.09 points; 95% CI, 0.15-2.03 points; P = .02). In subgroup analysis (8 studies), the addition of music to standard treatment for a range of conditions was associated with significant improvements in MCS scores vs standard treatment alone (mean difference, 3.72 points; 95% CI, 0.40-7.05 points; P = .03). Effect sizes did not vary between music intervention types or doses; no evidence of small study or publication biases was present in any analysis. Mean difference in MCS scores met SF-36 minimum important difference thresholds (mean difference 3 or greater). In this systematic review and meta-analysis, music interventions were associated with clinically meaningful improvements in HRQOL; however, substantial individual variation in intervention outcomes precluded conclusions regarding optimal music interventions and doses for distinct clinical and public health scenarios.

Comparing SF-36 Scores Collected Through Web-Based Questionnaire Self-completions and Telephone Interviews: An Ancillary Study of the SENTIPAT Multicenter Randomized Controlled Trial.

BackgroundThe 36-Item Short Form Health Survey (SF-36) is a popular questionnaire for measuring the self-perception of quality of life in a given population of interest. Processing the answers of a participant comprises the calculation of 10 scores corresponding to 8 scales measuring several aspects of perceived health and 2 summary components (physical and mental). Surprisingly, no study has compared score values issued from a telephone interview versus those from an internet-based questionnaire self-completion.ObjectiveThis study aims to compare the SF-36 score values issued from a telephone interview versus those from an internet-based questionnaire self-completion.MethodsPatients with an internet connection and returning home after hospital discharge were enrolled in the SENTIPAT multicenter randomized trial on the day of discharge. They were randomized to either self-completing a set of questionnaires using a dedicated website (internet group) or providing answers to the same questionnaires administered during a telephone interview (telephone group). This ancillary study of the trial compared SF-36 data related to the posthospitalization period in these 2 groups. To anticipate the potential unbalanced characteristics of the responders in the 2 groups, the impact of the mode of administration of the questionnaire on score differences was investigated using a matched sample of individuals originating from the internet and telephone groups (1:1 ratio), in which the matching procedure was based on a propensity score approach. SF-36 scores observed in the internet and telephone groups were compared using the Wilcoxon-Mann-Whitney test, and the score differences between the 2 groups were also examined according to Cohen effect size.ResultsOverall, 29.2% (245/840) and 75% (630/840) of SF-36 questionnaires were completed in the internet and telephone groups, respectively (P<.001). Globally, the score differences between groups before matching were similar to those observed in the matched sample. Mean scores observed in the telephone group were all above the corresponding values observed in the internet group. After matching, score differences in 6 out of the 8 SF-36 scales were statistically significant, with a mean difference greater than 5 for 4 scales and an associated mild effect size ranging from 0.22 to 0.29, and with a mean difference near this threshold for 2 other scales (4.57 and 4.56) and a low corresponding effect size (0.18 and 0.16, respectively).ConclusionsThe telephone mode of administration of SF-36 involved an interviewer effect, increasing SF-36 scores. Questionnaire self-completion via the internet should be preferred, and surveys combining various administration methods should be avoided.Trial RegistrationClinicalTrials.gov NCT01769261; https://www.clinicaltrials.gov/ct2/show/record/NCT01769261

POSA272 Using Real World Evidence to Characterise Utility in Patients with a Rare Disease: Analysis of Pompe Registry Data

Obtaining utility values for disease modelling in rare conditions is challenging. Late-onset Pompe disease (LOPD), an inherited metabolic disorder, is characterised by progressive muscle weakness leading to increasing disability and patient dependence on wheelchair and ventilator use. There is scarce evidence on the utility associated with disability, however, SF-36 is frequently measured in clinical practice. This research aims to investigate the impact of need for wheelchair and ventilator use on utility in patients with LOPD using SF-36 data from the Pompe Registry (NTC00231400/Sanofi Genzyme).

Effects of a Yoga-Based Exercise Program on Health-Related Quality of Life in Breast Cancer Survivors

Research Objectives To examine the impact of six months of exercise on a Health Related Quality of Life (HR-QOL) outcomes in post treatment breast cancer survivors in the San Antonio area in Texas. Design Randomized Controlled Trial. Setting The exercise program was run at a comprehensive cancer care facility. Participants Women with breast cancer (n=94) were randomized into one of three groups: yoga-based exercise (YE; n=31); “conventional” comprehensive exercise (aerobic, resistance and flexibility; CE; n=31); or a comparison group allowing participants to choose their own preferred exercise activities (C; n=32). 72 participants completed the 6 month long exercise program (YE: n=20; CE: n=26 and C: n=26). One year retention testing was completed by 64 participants (YE: n=17; CE: n=21, C: n=24). Interventions All groups exercised three hours weekly over six months. The YE group had a structured Hatha yoga exercise program emphasizing breath awareness and postures. The exercise program for the CE group included aerobic, resistance, and flexibility training. The C group could choose from a variety of activities including aerobics, strength training, Tai Chi, and water aerobics. Main Outcome Measures The SF-36 Physical and Mental Component Scales [PCS, MCS] were used to evaluate HrQoL. Sleep quality was assessed using Pittsburgh Sleep Quality Index (PSQI). SF-36 data was collected at baseline, post and retention. PSQI data was collected baseline and post-intervention only. Results At retention testing, PCS scores improved significantly in the YE group compared C and CE groups (p < 0.025). All participants improved PCS and MCS scores with no between group differences. No change was seen in PSQI scores. Conclusions A yoga-based exercise program can positively impact the physical component of HR-QOL in breast cancer survivors, particularly after completion of the intervention. Whether the HR-QOL continues to improve beyond one year needs further research. Author(s) Disclosures The authors would like to acknowledge all the participants for their commitment to the study and support of Dr. Amy Lang, the ThriveWell Cancer Foundation, and the START Center for Cancer Care. The authors have no other conflicts of interest to declare. To examine the impact of six months of exercise on a Health Related Quality of Life (HR-QOL) outcomes in post treatment breast cancer survivors in the San Antonio area in Texas. Randomized Controlled Trial. The exercise program was run at a comprehensive cancer care facility. Women with breast cancer (n=94) were randomized into one of three groups: yoga-based exercise (YE; n=31); “conventional” comprehensive exercise (aerobic, resistance and flexibility; CE; n=31); or a comparison group allowing participants to choose their own preferred exercise activities (C; n=32). 72 participants completed the 6 month long exercise program (YE: n=20; CE: n=26 and C: n=26). One year retention testing was completed by 64 participants (YE: n=17; CE: n=21, C: n=24). All groups exercised three hours weekly over six months. The YE group had a structured Hatha yoga exercise program emphasizing breath awareness and postures. The exercise program for the CE group included aerobic, resistance, and flexibility training. The C group could choose from a variety of activities including aerobics, strength training, Tai Chi, and water aerobics. The SF-36 Physical and Mental Component Scales [PCS, MCS] were used to evaluate HrQoL. Sleep quality was assessed using Pittsburgh Sleep Quality Index (PSQI). SF-36 data was collected at baseline, post and retention. PSQI data was collected baseline and post-intervention only. At retention testing, PCS scores improved significantly in the YE group compared C and CE groups (p < 0.025). All participants improved PCS and MCS scores with no between group differences. No change was seen in PSQI scores. A yoga-based exercise program can positively impact the physical component of HR-QOL in breast cancer survivors, particularly after completion of the intervention. Whether the HR-QOL continues to improve beyond one year needs further research.

102Assessing the characteristics of health state utilities among people living with multiple sclerosis

Abstract Background While many studies have examined the impacts of multiple sclerosis (MS) on health-related quality-of-life (HRQoL), none have used the SF-6D multi-attribute utility instrument in a large international cohort (&amp;gt;2,000 subjects) of people with MS. Our objective was to derive SF-6D health state utilities (HSUs) for participants of the HOLISM international cohort and to describe the distribution and determinants thereof. Methods HSUs were generated using the SF-6D for the Version-1 United States SF-36 for participants with sufficient SF-36 data (n = 2,185/2,466 (88.6%)). Determinants of HSU were evaluated by linear regression, adjusted for age, sex, MS type, disability (Patient-Determined MS Severity Scale), fatigue (Fatigue Severity Scale), and prescription antidepressant use. Results Mean HSU for the sample was 0.67 (SD = 0.13) and diminished with increasing MS-related disability. These findings were robust to adjustment, supporting the SF-6D’s discriminatory power in people with MS. Severe disability and clinically significant fatigue were each associated with 11%-lower HSU (95%CI=-0.13,-0.10 &amp; -0.12,-0.10), and depression risk (Patient Health Questionnaire-2) with 10%-lower HSU (95%CI=-0.11,-0.08). Employment, higher socioeconomic and married/partnered statuses, larger social-network size, greater physical activity, vitamin D and omega-3 supplementations were associated with significantly higher HSU, and overweight/obese BMI and tobacco smoking with lower HSU. Age, sex, and education were not associated. Conclusions The SF-6D revealed significant discriminatory power for the HOLISM international cohort. Modifiable lifestyle factors including diet, physical activity and supplement use for the international cohort were robustly associated with increased HSU and thus HRQoL. Confirmatory longitudinal HSU evidence could provide further support to our baseline findings using the SF-6D. Key messages Health state utilities in this sample of people living with MS were moderate and were significantly lower among those with greater disability, fatigue, and depression, while some lifestyle factors like physical activity and supplement use were associated with higher utility scores.

Predictive value of sagittal craniocervical roentgenographic parameters for HRQOL after craniocervical fusion.

Loss of "physiological" sagittal alignment following craniocervical fusion (CCF) for degenerative disease may be associated with loss of horizontal gaze, dysphagia and poor HRQOL. This study reports on sagittal craniocervical roentgenographic predictors of HRQOL (SF-36) in patients following uncomplicated CCF for fresh upper cervical traumatic (UCT) injuries. Twenty-two consecutive adult patients (group P) aged 50 ± 16years, who had undergone CCF for fresh unstable C1 and C2AO/type UCT injuries, were evaluated 39 ± 12months postoperatively with upright lateral cervical roentgenograms and SF-36as HRQOL measure. Physiological data for cervical sagittal alignment and SF-36 were taken from an age-matched control group (C) of 30 individuals aged 52 ± 12years. Several commonly used sagittal cervical roentgenographic parameters were tested as potential predictors of the SF-36 domains in both groups. Roentgenographic predictors for each of the nine SF-domains were calculated using stepwise multilinear regression analysis (MLRA). The roentgenographic predictors in patients included (1) the angle created by McGregor's line and the inferior surface of the axis (OC2a) for physical function (PF, P = 0.049), role limitations due to physical health (RLPH, P = 0.004),role limitation due to emotional problems (RLEP, P = 0.004), emotional functioning (EF) (P = 0.012), social functioning (SF) (P = 0.028) and general health (GH, P = 0.041). (2) The angle formed between a horizontal line and the superior endplate of T1-vertebra (T1-slope) was predictor for SF (P = 0.017) and pain (P = 0.021), and (3) the angle between McGregor's line and the line that links the center of the C1 anterior arch and the apex of cervical sagittal curvature (PIA) was predictor for health change (HC, P = 0.002). This study showed that postoperative OC2a, PIA and T1-slope safely predict HRQOL outcomes (SF-36) following CCF for fresh trauma. It seems theoretically that the adequate restoration of the upper cervical alignment including C1-C2 upper cervical lordosis (OC2a) and PIA, in interaction with T1-slope, is important for postoperative HRQOL scores close to physiological values. The authors speculate that C0-C4 fusion restores horizontal gaze and allows for painful regain of pre-trauma quality of life. Spine surgeons should realign and stabilize the craniocervical junction taking in consideration these roentgenographic predictors.

Self-Reported Satisfaction to Treatment, Quality of Life and General Health of Type 2 Diabetes Patients with Inadequate Glycemic Control from North-Eastern Romania.

Type 2 diabetes mellitus (T2DM) undermines health and quality of life (QoL). This cross-sectional study surveyed 138 consenting T2DM patients from North-Eastern Romania with regard to their satisfaction with treatment, diabetes-related impact on QoL, and general health. The Romanian versions of Diabetes Treatment Satisfaction Questionnaire (DTSQ), Audit of Diabetes Dependent Quality of Life (ADDQoL-19), and 36-Item Short Form Health Survey (SF-36) questionnaires were used. Self-reports were analyzed in conjunction with clinical and metabolic profiling. The patients were 57.86 ± 8.82 years old, 49.3% men, treated with oral glucose-lowering drugs, presenting with inadequate glycemic control but without cardiovascular manifestations. The mean DTSQ and ADDQoL scores were 25.46 ± 0.61 and −2.22 ± 1.2, respectively. Freedom to eat, holidays, journeys, leisure, physical health, sex life, freedom to drink, and feelings about the future scored below average. The mean SF-36 physical and mental health scores were 47.78 ± 1.03 and 50.44 ± 1.38, respectively. The mean SF-6D score was 0.59 ± 0.04 (generated retrospectively using SF-36 data). Negative associations were significant between ADDQoL, age (r = −0.16), and body mass index (r = −0.23), p < 0.01. Overall scores did not correlate with diabetes duration (except DTSQ, r = −1.18, p = 0.02) or HbA1c. The results confirm other researchers’ findings in Europe and nearby countries. Our patients seemed satisfied with treatment despite glycemic imbalance and viewed diabetes as a burden on QoL and especially freedom to eat.

Impact of COVID-19 on the pain and disability of patients with adult spinal deformity.

PurposeTo evaluate the pain and functional effect of the COVID-19 pandemic on patients with ASD reflected by their response to SRS-22, ODI, and SF-36 questionnaires.MethodsPatients who had stable pain and functional outcome scores over the preceding 2 years were enrolled in a local prospectively collected adult spinal deformity (ASD) database. A reanalysis of their SRS22, ODI and SF-36 data 14 days into confinement were compared to their last pre-confinement scores.Results89 patients were included in this study (average age 60.7 years, 91% female) with an average time from last FU until confinement of 9.6 months. The ODI total score worsened by 5 points post-confinement with no difference seen in personal care, walking and social life. In contrast, the SRS-22 score showed small improvements in function/activity and satisfaction, but no significant differences for the other domains. Similarly, the SF-36 showed small improvements in physical function, physical and emotional role, vitality and PCS.ConclusionThe global COVID-19 pandemic and ensuing confinement had variable overall effects on ASD patients, without the expected marked worsening. In addition, this study illustrates that the SRS-22 questionnaire is less influenced by environmental and psychological factors than the ODI supporting its objectivity and accuracy in the evaluation of the QoL of ASD patients.

Evaluation of Peripartum Hysterectomy in a Tertiary Care Unit and Its Effect on Patients' Long-Term Physical and Mental Wellbeing: Quest Is Not Over When You Save the Life.

Objectives Peripartum hysterectomy can be performed as an elective procedure or as a life-saving emergency procedure in obstetrics. It is associated with significant maternal morbidity and mortality. We report peripartum hysterectomies done during the study period in a tertiary referral centre, Colombo, Sri Lanka. Methodology. We collected data on all severe acute maternal morbidity and mortality events (SAMM) from June 01, 2014, to June 01, 2015, at De Soysa Hospital for Women (DSHW). We invited all women who underwent PPH to complete the 36-Item Short Form Health Survey questionnaire (SF-36) before hospital discharge and at six months after the hysterectomy date to assess their general and mental health before and after surgery. Focus group discussions (FGD) were used to further evaluate the patient experience and to identify service delivery improvements. Results There were eleven peripartum hysterectomies done during the study period for 7160 deliveries. None were primigravida. Median age and gestation were 36 years and 37 weeks, respectively. The commonest indication for peripartum hysterectomy was a morbidly adherent placenta (seven). Nine of the deliveries were elective lower-segment caesarean section and two were vaginal deliveries. Four emergency peripartum hysterectomies were done for primary postpartum haemorrhage (PPH) and two for secondary PPH. All patients required intensive care and there were no maternal deaths. The analysis of SF-36 data revealed that all patients suffered a significant reduction in the quality of life at six months after the surgery. FGD highlighted that most patients needed further counselling and support to improve their physical, psychological, and social wellbeing. Some of the patients were willing to share their experience on voluntary basis to help those undergoing peripartum hysterectomies in the future. Conclusion Peripartum hysterectomy is an important life-saving procedure associated with severe maternal morbidity and mortality. This study reveals that the physical, psychological, and social adverse effects would remain in the long term.