SF-36 Data Research Articles

The Effects Of Aerobic And/Or Resistance Training On The Sf-36 Health Survey From Strride-AT/RT

PURPOSE: While exercise has numerous health benefits, the optimal exercise mode is unknown. Many organizations recommend aerobic training (AT) and resistance training (RT), yet few studies have compared their effects alone or in combination. The purpose of this study, as part of the Studies Targeting Risk Reduction Interventions through Defined Exercise – AT/RT (STRRIDE AT/RT), was to compare the effects of AT, RT and the combination of the complete AT and complete RT training programs on the Physical and Mental Component scores from the SF-36 Health Survey. METHODS: Subjects were 18-70 y, sedentary, overweight/obese with moderate dyslipidemia. Of those randomized, 74% or 155 subjects completed the 8-month intervention. A subset of participants (132) had complete SF-36 data pre and post training. The randomized training groups were: 1) Resistance Training (RT) (3 d/wk, 3 sets/day, 8-12 rep/set] for 8 RT exercises = 72 sets/wk (~ 135-160 min/wk), 2) Aerobic Training (AT), [equivalent to ~12 miles/wk at 65-80% peak VO2], required an average of 133 min/wk, 3) Aerobic Training + Resistance Training (AT/RT = complete RT + complete AT). RESULTS: Figures show intervention effects on change in the Physical and Mental Component scores from the SF-36 questionnaire. The p-values inside each bar indicate significant within group changes. The bars with p-values connecting 2 groups show a significant difference between groups. SUMMARY: All exercise groups experienced significant improvements in Physical Component score. However, only the AT/RT group had a significant improvement in the Mental Component score. Further, the AT/RT group experienced significantly greater improvements in both component scores compared to the AT and RT alone groups. Finally, the AT/RT group appeared to have an additive response (i.e., AT/RT = AT + RT) for the Physical Component score; whereas, the improvement in the mental component score suggests a synergistic (greater than additive) response.

SF-6D health state utilities for lifestyle, sociodemographic and clinical characteristics of a large international cohort of people with multiple sclerosis.

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 (> 2000 subjects) of people with MS. To derive SF-6D health state utilities (HSUs) for participants of the HOLISM (Health Outcomes and Lifestyle In a Sample of people with Multiple Sclerosis) international cohort and to describe the distribution and determinants thereof. HSUs were generated using the SF-6D for participants with sufficient SF-36 data [n = 2185/2466 (88.6%)]. Mean HSUs for sociodemographic, clinical and modifiable lifestyle factors (including diet, physical activity, supplement use) were evaluated. Determinants of HSU were then evaluated by linear regression, adjusted for age, sex, MS type, disability, fatigue, and prescription antidepressant use. Mean HSU for the sample was 0.67 (SD = 0.13) and diminished with increasing MS-related disability, 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 and -0.12, -0.10), and depression risk with 10%-lower HSU (95% CI = -0.11, -0.08). Employment, higher socioeconomic and married/partnered statuses, larger social-network size, greater physical activity, andvitamin D and omega-3 supplementuse were associated with significantly higher HSU, and overweight/obese BMI and tobacco smoking with lower HSU. Age, sex, and education were not associated. Modifiable lifestyle factors including healthy diet, increased physical activity and supplement use were associated with higher HRQOL among people with MS. The SF-6D instrument revealed significant discriminatory power in this international cohort of people with MS.

PDB43 QUALITY ADJUSTED LIFE YEARS (QALYS) IN THE DIABETES PREVENTION PROGRAM (DPP): QUALITY OF WELL BEING (QWB) VERSUS SF-6D INSTRUMENTS

A within-trial DPP cost-effectiveness analysis (CEA) was published in 2003. The authors reported QALYs using utilities from the QWB for lifestyle (LS), placebo (PBO), and metformin (MET). Available to them, but not used, were more complete SF-6D results (calculable from their SF-36 data). QALY calculations were also not done correctly in the DPP. The main objective of this study is to estimate utilities and incremental QALYs using both instruments and correct method of calculation, comparing them and suggesting implications for CEA. We calculated QALYs correctly for the QWB results and compared them to the original reporting. We then mapped the SF-36 data to the SF-6D and calculated QALYs as in the original DPP CEA (incorrectly) and in the correct manner. The corrected calculation used area under the curve, based on beginning and end of the year utilities. It required a baseline utilities values, not included in the original work. If in common across the treatments, the baseline drops out of the QALYs differences, but the corrected method still implies changes in these differences. The incremental QALYs using the QWB as originally calculated were 0.072, 0.022 and 0.050 for LS versus PBO, MET versus PBO, and LS versus MET. Corrected incremental QALYs were 0.056,0.015 and 0.041. Using the SF-6D utilities, incremental QALYs using incorrect and correct calculations were 0.031,0.002,0.029 and 0.027,0.003,0.024. QWB and SF-6D instruments in the DPP yielded different incremental QALYs in original and corrected calculations. Small differences in QALYs have been shown previously to be important in the DPP CEA conclusions. These differences are likely important in their CEA implications.

PDB28 QUALITY ADJUSTED LIFE YEARS (QALYS) IN THE DIABETES PREVENTION PROGRAM (DPP) USING QUALITY OF WELL BEING (QWB) AND SF-6D INSTRUMENTS IN SAME SAMPLE: COMPLETE CASE ANALYSIS

A within-trial 3 year DPP cost-effectiveness analysis (CEA) was published in 2003. The authors reported QALYs using utilities from the QWB for lifestyle (LS), placebo (PBO), and metformin (MET). QALY calculations were not done correctly in the DPP (year-end utilities were used as QALYs instead of average values between yearly measures). Available to them, but not used, were the more complete SF-6D utilities (calculable from their SF-36 data). The main objective of this research was to estimate incremental QALYs using both instruments on the same sample and with the corrected method of calculation, comparing them with previous results and suggesting implications for CEA. We had access to a 95% subset of the DPP data. We calculated QWB-based QALYs correctly. We then mapped the SF-36 data to the SF-6D and calculated QALYs. The corrected calculation used area under the curve, based on beginning and end of the year utilities. It required (unreported) baseline utilities values. If baseline was equal across the treatments (plausible given the large sample and randomized allocation), the baseline drops out of the QALY differences, but the corrected method still implies changes in these differences. The incremental QALYs using QWB as originally calculated were 0.072, 0.022 and 0.050 for LS versus PBO, MET versus PBO, and LS versus MET. The corrected incremental QWB-based QALYs were 0.051, 0.00004, 0.051. SF-6D–based incremental QALYs were 0.030, -0.012, 0.042. QWB and SF-6D instruments in the DPP yielded different incremental QALYs in same sample using correct QALY calculations; both were different from the published incorrect values. Small differences in QALYs have been shown previously to be important in the DPP CEA conclusions. These differences are quite significant and likely impact CEA results.

690 Ustekinumab Maintained Clinically Meaningful Improvement in Health-Related Quality of Life in Patients With Moderate to Severe Crohn's Disease: Results From the IM-UNITI Long-Term Extension

INTRODUCTION: The IM-UNITI study evaluated the safety and efficacy of subcutaneous (SC) ustekinumab (UST) maintenance therapy in patients with moderately to severely active Crohn's disease (CD) who completed induction treatment with UST. Previously, we reported the effects of UST on health-related quality of life (HRQoL) through Wk44. Here, we evaluated HRQoL through Wk140 in patients who entered the long-term extension of the IM-UNITI study. METHODS: Patients who completed the safety and efficacy evaluation at Wk 44 of the maintenance study were eligible to continue their regimen in the extension study (placebo [PBO], UST 90 mg q12w, or UST 90 mg q8w). All patients who were treated in the extension study were included in this analysis of Inflammatory Bowel Disease Questionnaire (IBDQ) and SF-36 data according to the treatment they received during the extension study. The IBDQ is a 32-item questionnaire with 4 dimensions: bowel symptoms, systemic symptoms, emotional function, and social function. The total score ranges from 32 to 224, higher scores indicate better quality of life, and a change ≥16 points was defined as clinically meaningful. For SF-36, a change ≥5 points was defined as clinically meaningful. RESULTS: For patients who entered the extension, mean total IBDQ scores and SF-36 scores at maintenance baseline were comparable across treatment groups (Table 1). Patients who received UST maintained the improvement in IBDQ and SF-36 that was achieved by maintenance baseline through Wk140, and those who received PBO generally worsened. Through Wk 140, 26.5% of patients receiving PBO, 61.5% of patients receiving UST 90 mg q12w, and 59.3% of patients receiving UST 90 mg q8w had ≥16-point improvements from induction baseline in IBDQ score. In addition, 10.9%, 51.6%, and 54.2%, respectively, had ≥5-point improvements in SF-36 physical component summary scores, and 8.7%, 43.8%, and 43.7%, respectively, had ≥5-point improvements in SF-36 mental component summary scores during the same period. CONCLUSION: In patients who entered the long-term extension of the IM-UNITI study, those who received SC UST maintenance generally maintained improvements in IBDQ and SF-36 scores that were achieved through IV induction, and those who received PBO gradually lost these improvements.

13-year Follow-up of Treatment of Osteochondral Lesions with MACI

Category:Ankle, Arthroscopy, Hindfoot, Sports, TraumaIntroduction/Purpose:Surgical management of osteochondral lesions of the talus (OLT) present an ongoing treatment challenge. Previously, matrix-induced autologous chondrocyte implantation (MACI) demonstrated improved pain and function at 7-years postoperative, providing evidence that MACI is a reliable method for treating cartilage. However, it is unknown the long- term results of MACI in OLT. The purpose of this study was to assess 13-year clinical follow-up data and the long-term success of this implant by comparing patient reported outcome measures (PROMs) pre-operatively, at 7-years post-operative, and at 13- years post-operative.Methods:A prospective investigation of MACI was performed on 10 patients with OLTs who had failed previous arthroscopic treatment. Of the 10 patients, 9 were available for 7-year and 13-year follow-up. Short Form Health Survey (SF-36) and the American Orthopaedic Foot & Ankle Society (AOFAS) hindfoot evaluation were utilized at pre-operative, 7-year, a 13-year postoperative. For each patient, a paired t-test was used to compare 13-year post-operative PROMs to pre-operative PROMs. A single factor analysis of variance (ANOVA) determined whether PROMs were different between pre-operative, 7-year post- operative, and 13-year post-operative time intervals. When a significant difference was detected, a post-hoc Tukey’s determined which time periods were different.Results:SF-36 data at 13-years showed significant improvements in Physical Functioning (p=0.012), Lack of Bodily Pain (p=0.017), and Social Functioning (p=0.007) compared with preoperative data. There were no differences in other components of the SF-36 outcomes (p>0.05). Although the AOFAS was on average 12 points higher at 13-years postoperative, this was not statistically significant (p=0.173). As for comparing PROMs over time, 13-years post-operative PROMs were comparable to 7-years post- operative (Table 1). There were better PROMs for Physical Functioning, Bodily Pain, and Social Functioning at 7- and 13-years post-operative compared to pre-operative while Physical Role Functioning was also better at 7-years post-operative compared to pre-operative.Conclusion:This study shows MACI provides greater pain relief and function at 13-years post-operative with stable long-term follow-up. MACI should be considered for osteochondral lesions that fail initial microfracture.

MON-LB042 Health-Related Quality of Life in Women with Polycystic Ovary Syndrome/Anovulatory Androgen Excess versus Local Population-Based Control Women (from the British Columbia Canadian Multicentre Osteoporosis Study [BC CaMos

Polycystic Ovary Syndrome (PCOS) affects 5-20% of reproductive-aged women and is associated with lower Health-Related Quality of Life (HRQoL)1,2,3. HRQoL in PCOS, however, is often determined in small or clinical samples with no or convenience sample controls. Our aim was to cross-sectionally compare generic SF-36 HRQoL results in community dwelling, physician-diagnosed women with PCOS to randomly selected age-similar local women. Women with PCOS/AAE had enrolled in two local studies (n = 93)4, and were eligible if they were non-menopausal and had PCOS based on Androgen Excess/PCOS Society criteria. Eligibility in both groups required age ≤53 years and, for controls, menstruation in the last year. Control women were from both Adult and Youth BC CaMos cohorts (n = 56). All completed the interviewer-administered CaMos questionnaire5. Statistical analysis used descriptive, T-test and multiple regression to explore relationships among HRQoL domains/component scores versus demographic, anthropomorphic and comorbid condition variables, particularly body mass index (BMI), physical activity patterns and combined hormonal contraceptive (CHC) usage. We compared SF-36 data in pre/perimenopausal women mean aged 34.5±10.0 (SD) years, BMI 27.5±7.5. After controlling for BMI, education, comorbidities and past use of CHC, all HRQoL domain and component scores were significantly lower in women with PCOS then in controls. Domain score differences of 5 are clinically important; PCOS women scored -5.8 to -19.9 points lower (mean -11.6) with the greatest difference for Emotional Role. The Physical Component summary score was -2.2 and the Mental Component summary -7.2 lower in women with PCOS compared with population-based controls; score differences of 2-3 are considered clinically important. In both groups, participation in regular exercise was the strongest predictor of higher overall HRQoL. In both cohorts, comorbidity negatively predicted the physical component score (PCS) of HRQoL; PCOS status negatively predicted the mental component score of HRQoL. PCS group differences became less significant as BMI increased, but MCS remained significantly different. This first comparison of the validated, generic SF-36 in pre/perimenopausal population-based versus women with PCOS documented highly significantly lower scores in women with PCOS on all domains and both components. These data confirm evidence that participation in regular exercise is related to better overall HRQoL in PCOS. Also, obesity in women with PCOS, in contrast to controls, was not associated with the overall HRQoL. We also found that CHC was associated with general health, mental health and mental component scores in women with PCOS. Ref.1Prior JCEM 2014; 2Alvarez-Blasco Clin Endo 2010; 3Azziz Fertil Steril 2009; 4Kalyan Sci Reports 2017; 5Kreiger Can J. Aging 1999. Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. s presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.

Safety and tolerability of sauna detoxification for the protracted withdrawal symptoms of substance abuse

ObjectiveProtracted drug withdrawal symptoms can last months or years after drug cessation, often precipitating a return to substance misuse. We evaluated the safety and preliminary health benefits of a unique chemical exposure regimen based on exercise, sauna and therapeutic nutrients.MethodsThis was a prospective evaluation of 109 individuals sequentially enrolled into a sauna detoxification component of a multi-modal, long-term residential substance abuse treatment centre.ResultsData from medical charts, client self-reports and Short Form Health Survey (SF-36) responses indicated that the Hubbard sauna detoxification method was well tolerated, with a 99% completion rate, including one human immunodeficiency virus and nine hepatitis C positive clients. There were no cases of dehydration, overhydration or heat illness. Statistically significant improvements were seen in both mental and physical SF-36 scores at regimen completion, as well as in Addiction Severity Index and Global Appraisal of Individual Needs Short Screener change scores at rehabilitation program discharge, compared with enrolment.ConclusionsThe regimen lacked serious adverse events, had a very low discontinuation rate and high client-reported satisfaction. The SF-36 data indicated improved physical and emotional symptoms. Therefore, broader investigation of this sauna-based treatment regimen is warranted.

Cervical and postural strategies for maintaining horizontal gaze in asymptomatic adults.

To investigate the different cervical strategies for maintaining horizontal gaze in asymptomatic subjects. One hundred and forty-four asymptomatic adults filled the SF-36 quality of life questionnaire and underwent full-body biplanar radiographs. Chin brow vertical angle (CBVA) and postural and cervical parameters were measured. Subjects were grouped according to cervical spine curvature (C2-C7 angle): kyphotic (< - 5°), straight [- 5°, 5°], lordotic (> 5°). Demographics, SF-36 component scores and CBVA were compared between groups. All other parameters were compared between groups, while controlling for confounding factors (ANCOVA). A correlation test was conducted between all cervical parameters. 32% of subjects had kyphotic (- 12° ± 7°), 27% straight (0° ± 3°) and 41% lordotic (12° ± 7°) cervical spines. While demographic and SF-36 data did not differ between groups, CBVA differed between lordotic and kyphotic groups (2° vs. 6.5°, p = 0.002). Sagittal vertical axis (SVA) and thoracic kyphosis (TK) were lower in the kyphotic group (SVA: K = - 26 ± 20mm vs. L = - 2 ± 21mm, p < 0.001; TK: K = 40° ± 6° vs. L = 51° ± 8°, p < 0.001). C2 slope (K = 29° ± 6° vs. L = 18° ± 6°, p < 0.001), C0-C2 (K = 42° ± 8° vs. L = 30° ± 8°, p < 0.001) and C1-C2 (K = 33° ± 6° vs. L = 28° ± 6°, p = 0.004) were higher in the kyphotic group. Significant correlations were found between almost all cervical parameters and C2-C7 angle. Subjects with cervical kyphosis presented with more posterior global alignment and lower TK than subjects with lordosis. In order to maintain horizontal gaze, subjects with cervical kyphosis presented with a more lordotic upper cervical spine than subjects with cervical lordosis. Subjects with straight cervical curvature presented with an intermediate sagittal alignment. These slides can be retrieved under Electronic Supplementary Material.

Quality of life after percutaneous closure of patent foramen ovale in patients after cryptogenic stroke compared to a normative sample

AimsDespite the widespread use of percutaneous closure of patent foramen ovale (PFO) in patients after a cryptogenic stroke, little is known about its impact on health-related quality of life (HRQoL). The aim of this study was to assess HRQoL in these patients compared to PFO patients not considered candidates for percutaneous closure, and to a normal population. Methods and resultsA total of 402 patients with cryptogenic stroke or transient ischaemic attack (TIA) who had been referred to our center for PFO closure were invited to a long-term clinical follow-up (mean follow-up 5.5 years; range 3–13 years). HRQoL was assessed using the SF-36 Health Survey and data were compared with an age- and gender-matched reference group from the Swedish SF-36 normative database. Fifteen patients had died and 43 did not answer the SF-36. Of the remaining 344 patients, 208 had undergone PFO closure, and 136 had not. The closure group and reference group reported similar HRQoL levels. However, the non-closure group showed significantly lower HRQoL in role limitation – physical, vitality, general health, mental health (p < 0.05) and social functioning (p = 0.05) than the reference group and also had significantly lower scores than the closure group, correcting for age differences, on physical functioning, role limitation – physical, vitality and general health (p < 0.05). ConclusionsNon-closure patients had lower HRQoL than their counterparts in the normal population and the closure group. Percutaneous PFO closure is associated with a favorable quality of life.

Factors of influence upon the SF-36-based health related quality of life of patients following surgery for petroclival and lateral posterior surface of pyramid meningiomas

ObjectiveTo describe the patient's self assessed health related quality of life (saHRQoL) based upon the medical outcome study 36-item short form health survey (SF-36) as well as the factors of influence upon the saHRQoL following surgery for petroclival (PCM) and lateral posterior surface of the pyramid (LPPM) meningiomas. Patients and MethodsIn a series of 78 patients operated consecutively for PCM (n = 46) or LPPM (n = 32) the preoperative, intraoperative and postoperative data were collected retrospectively. The saHRQoL was obtained by mailing the SF-36 questionnaire to the patients. The SF-36 data of the whole patients group was compared with a healthy population. The SF-36 data of the PCM- and LPPM were compared to each other. The influence of pre-, intra- and postoperative findings upon the SF-36 was assessed by uni- and multifactorial analysis. Results58 (69%) out of the 78 patients answered the SF-36 questionnaire at a median postoperative follow-up of 59 months. The patients, who answered the SF-36 questionnaire, had a significant lower perioperative complication rate than those who did not (46% vs. 75%, p = 0.019). The saHRQoL of the LPPM and PCM was reduced on several sub-scales, when compared to the German reference population. The outcome of PCM is, assessed by saHRQoL as well as by conventional neurosurgical grading scales, inferior to that of LPPM. The saHRQoL of LPPM correlated in the uni- and multivariate analysis with the early postoperative KPI on the sub-scales SF1 (physical functioning) and SF5 (vitality). Accordingly, the sub-scale SF2 (role-physical) of PCM correlated with the change of the KPI from preoperative to the last follow up. ConclusionsThe saHRQoL of the evaluable patients was lower than that of the normal population. The saHRQoL score of PCM-patients was lower than that of LPPM-patients.For the future the saHRQol should be assessed routinely; It reflects the patients’ perspective upon postoperative outcome and enables the comparison with other treatment modalities of these difficult to treat tumors.

Health-Related Quality of Life of Older Adults in Costa Rica as Measured by the Short-Form-36 Health Survey.

Objective: To test the validity of a common measure of health-related quality of life (Short-Form-36 [SF-36]) in cognitively healthy older adults living in rural and urban Costa Rica. Method: Confirmatory factor analysis was applied to SF-36 data collected in 250 older adults from San Jose and Guanacaste, Costa Rica. Results: The best fitting model for the SF-36 was an eight first-order factor structure. A high correlation between the Mental Component Summary and Physical Component Summary scores was found. Region differences indicated that rural dwellers perceive a poorer health-related quality of life compared with the urban group. Discussion: Costa Rican older adults perceived health as a unidimensional construct. Age and urbanity of older adult Costa Ricans should be appreciated when trying to measure self-reported physical and mental health. Cultural context of the individuals should be considered when studying health-related quality of life.

Total Disc Replacement Versus Anterior-Posterior Interbody Fusion in the Lumbar Spine and Lumbosacral Junction: A Cost Analysis.

Study Design:Prospective observational cohort study.Objectives:To analyze clinical and economic results in patients with degenerative disc disease in the lumbar area for patients who received combined anterior and posterior fusion or total disc replacement (TDR).Methods:The study included 75 patients, 38 in the fusion group and 37 in the TDR group, who received either anterior/posterior fusion or TDR for lumbar disc disease from January 2005 to December 2008 with a minimum follow-up of 24 months. We collected data with regard to clinical parameters, demographics, visual analogue scale scores, Oswestry Disability Index scores, SF-36 and SF-6D data, surgery time, amount of blood loss, transfusion of blood products, number of levels, duration of hospital stay, and complications. For cost analysis, general infrastructure, theatre costs, as well as implant costs were examined, leading to primary hospital costs. Furthermore, average revision costs were examined, based on the actual data. Statistical analysis was performed using t tests for normal contribution and Mann-Whitney test for skew distributed values. The significance level was set to .05.Results:There was a higher surgery time, more blood loss, and longer hospital stay for the fusion group, compared with the TDR group. In addition, the hospital costs for the primary procedure and revision were 35% higher in the fusion group. The clinical data in terms of SF-36 and SF-6D showed no difference between these 2 groups.Conclusions:TDR is a good alternative to anterior and posterior lumbar fusion in terms of short follow-up analysis for clinical data and cost analysis. General advice cannot be given due to missing data for long-term costs in terms of surgical treatment of adjacent level or further fusion techniques.

Seven-Year Follow-up of Matrix-Induced Autologous Implantation in Talus Articular Defects.

Osteochondral lesions of the talus (OLT) are difficult to treat because of the poor intrinsic healing capability of articular cartilage. Matrix-induced autologous chondrocyte implantation (MACI) has been shown to be a reliable method for treating cartilage lesions that fail to respond to traditional microfracture and debridement. The purpose of this study was to assess 7-year clinical follow-up data of this technique and demonstrate midterm success of this implant. A prospective investigation of MACI was performed on 10 patients with OLTs who had failed previous arthroscopic treatment. In all, 5 male and 5 female patients were included in the study. Of the 10 patients, 9 were available for 7-year follow-up. Functional and clinical evaluations were done at 7 years postoperatively using the American Orthopaedic Foot and Ankle Society (AOFAS) hindfoot evaluation and the Short Form Health Survey (SF-36) and compared with preoperative values. SF-36 data at 7 years showed significant improvements in Physical Functioning (P < .01), Lack of Bodily Pain (P < .1), and Social Functioning (P < .001) compared with preoperative data. The mean AOFAS hindfoot scores of the 9 patients at 7 years was 78.3 ± 18.1 (P = .05) compared with their preoperative mean of 61.8 ± 14.3. MACI provides a stable midterm chondral replacement strategy for osteochondral lesions that fail initial microfracture. Level IV: Prospective case series.

Measurement properties and normative data for the Norwegian SF-36: results from a general population survey

BackgroundThe interpretation of the SF-36 in Norwegian populations largely uses normative data from 1996. This study presents data for the general population from 2002–2003 which has been used for comparative purposes but has not been assessed for measurement properties.MethodsAs part of the Norwegian Level of Living Survey 2002–2003, a postal survey was conducted comprising 9,164 members of the general population aged 16 years and over representative for Norway who received the Norwegian SF-36 version 1.2. The SF-36 was assessed against widely applied criteria including data completeness and assumptions relating to the construction and scoring of multi-item scales. Normative data are given for the eight SF-36 scales and the two summary scales (PCS, MCS) for eight age groups and gender.ResultsThere were 5,396 (58.9%) respondents. Item levels of missing data ranged from 0.6 to 3.0% with scale scores computable for 97.5 to 99.8% of respondents. All item-total correlations were above 0.4 and were of a similar level with the exceptions of the easiest and most difficult physical function items and two general health items. Cronbach’s alpha exceeded 0.8 for all scales. Under 5% of respondents scored at the floor for five scales. Role-physical had the highest floor effect (14.6%) and together with role-emotional had the highest ceiling effects (66.3-76.8%). With three exceptions for the eight age groups, females had lower scores than males across the eight health scales. The two youngest age groups (<30 years) had the highest scores for physical aspects of health; physical function, role-physical, bodily pain and general health. The age groups 40–49 and 60–69 years had the highest scores for role-emotional and mental health respectively.ConclusionsThis SF-36 data meet necessary criteria for applications of normative data. The data is more recent, has more respondents including older people than the original Norwegian normative data from 1996, and can help the interpretation of SF-36 scores in applications that include clinical and health services research.

Latent variable mixture models to test for differential item functioning: a population-based analysis

BackgroundComparisons of population health status using self-report measures such as the SF-36 rest on the assumption that the measured items have a common interpretation across sub-groups. However, self-report measures may be sensitive to differential item functioning (DIF), which occurs when sub-groups with the same underlying health status have a different probability of item response. This study tested for DIF on the SF-36 physical functioning (PF) and mental health (MH) sub-scales in population-based data using latent variable mixture models (LVMMs).MethodsData were from the Canadian Multicentre Osteoporosis Study (CaMos), a prospective national cohort study. LVMMs were applied to the ten PF and five MH SF-36 items. A standard two-parameter graded response model with one latent class was compared to multi-class LVMMs. Multivariable logistic regression models with pseudo-class random draws characterized the latent classes on demographic and health variables.ResultsThe CaMos cohort consisted of 9423 respondents. A three-class LVMM fit the PF sub-scale, with class proportions of 0.59, 0.24, and 0.17. For the MH sub-scale, a two-class model fit the data, with class proportions of 0.69 and 0.31. For PF items, the probabilities of reporting greater limitations were consistently higher in classes 2 and 3 than class 1. For MH items, respondents in class 2 reported more health problems than in class 1. Differences in item thresholds and factor loadings between one-class and multi-class models were observed for both sub-scales. Demographic and health variables were associated with class membership.ConclusionsThis study revealed DIF in population-based SF-36 data; the results suggest that PF and MH sub-scale scores may not be comparable across sub-groups defined by demographic and health status variables, although effects were frequently small to moderate in size. Evaluation of DIF should be a routine step when analysing population-based self-report data to ensure valid comparisons amongst sub-groups.

Outcomes in patients with over 1-year follow-up after peroral endoscopic myotomy (POEM).

Peroral endoscopic myotomy (POEM) is a promising therapy in the treatment of achalasia. The study was designed to report outcomes, including quality of life, in patients with at least 1-year follow-up. Patients from an institutional review board-approved protocol underwent POEM and were followed prospectively. Health-related quality of life was measured preoperatively and 1year post-operatively using Short Form-36 Health Survey version 2 (SF-36v2). Comparisons were made with patients from a prospective database who underwent laparoscopic Heller myotomy (LHM) over the same period. Paired t tests were used to analyze all normally distributed data, while Wilcoxon signed-rank tests were used to analyze SF-36 data, as it does not follow a normal distribution. We analyzed 41 consecutive POEM patients with at least 1-year follow-up. Significant improvements in quality of life between baseline and 1year were found in role limitations due to physical health (81.8±25.8 vs. 65.9±31.6, p=0.01) and social functioning (83±19.1 vs. 64.6±31.3, p=0.01). When compared to 24 patients who underwent LHM, there was no difference in average Eckardt scores (0.9±1.6 vs. 1.0±1.3, p>0.05) or incidence of PPI use (43.5 vs. 47.5%, p=0.71). However, when looking at just type III patients, POEM patients had a higher remission rate (100 vs. 62.5%) and significantly lower post-operative Eckardt scores at 1year (1.1 vs. 3.1, p<0.05). The average myotomy length of type III achalasia patients undergoing POEM was 18.6cm (±6.9) compared to 10.3cm (±1.0) in LHM patients (p<0.01), which may have contributed to this difference. POEM provides a significant quality of life benefit at 1year while having similar relief of dysphagia and post-operative PPI use compared to LHM. Type III achalasia patients may have better outcomes with POEM compared to LHM.

PDB75 - Quality of Life (QOL) and Health Utility (UT) in Patients with Type 2 Diabetes Mellitus (DM2) Receiving Different Oral Hypoglycemic Therapy in a Real-World Setting

We aimed to evaluate QoL and Ut in DM2 patients receiving vildagliptin or sulphonylureas (SU) add-on to metformin therapy in a real-world setting. In the whole, 229 DM2 patients (mean age – 61.3±9.5 years, 68.1% females) receiving vildagliptin add-on to metformin/GalvusMet (Group 1, n=104) or SU add-on to metformin (Group 2, n=125) were enrolled in the real-world multicenter observational study. Mean disease duration was 5.9±4.1 years, mean HbA1с level – 6.9%±0.8%, late complications were revealed in 27.5% of patients, comorbidities – in 64.6%. All the patients completed SF-36 questionnaire. The Ut scores were calculated for each patient on the basis of SF-6D questionnaire. The SF-6D utility indexes were obtained from SF-36 data. The mean Ut for each treatment group was calculated with adjustment for gender, age, comorbidities, late complications and HbA1с level. Group comparisons were made using General linear models with adjustment for age, comorbidities and late complications. It was shown that patients in Group 1 had higher QoL by the majority of SF-36 scales: role physical functioning – 74.3 vs 50.3; bodily pain – 82.9 vs 69.1; general health – 56.5 vs 47.7; vitality – 64.4 vs 56.0; social functioning – 83.7 vs 72.5; role emotional functioning – 86.1 vs 58.4 (p<0.05). Integral QoL Index in Group 1 was higher – 0.525 vs 0.351 (p<0.001). The significant difference between Ut values for two groups was revealed: the mean Ut for Group 1 was higher as compared to mean Ut for Group 2 – 0.757 vs 0.701 (p<0.05). Results of this real-world study demonstrate benefits of treatment with vildagliptin add-on to metformin/GalvusMet in DM2 patients as compared to SU add-on to metformin in terms of better QoL and higher health utility. The data obtained may be used for cost-utility analysis and be further applied for health technology assessment.

Perioperative Quality of Life in Cushing's Disease.

Our study evaluated the perioperative quality of life (QoL) in Cushing's disease (CD) patients, along with correlations between patient variables and cure rate. The 36-item Short-Form Health Survey (SF)-36 questionnaire was used to assess perioperative QoL. Patients completed one survey preoperatively and two surveys postoperatively. Retrospective chart review was conducted to collect SF-36 data as well as examine variables including: age, hospital stay, size of tumour, pathological diagnosis, timing of cure, and complication rates. Statistical analysis was conducted on the scores reported by the SF-36, and were compared with the normal Canadian population values, and to a sample of QoL from nonfunctioning pituitary tumour patients. This project was approved by University of British Columbia Research Ethics Board #H15-01572. In general, CD patients have relatively poor QoL that does improve as expected when cured, but not quite to normal levels. Factors associated with cure included presence of macroadenoma, confirmatory pathology, and patient age. Postoperative timing of cure appears to affect the durability of cure, with an immediate cure having a higher durability rate than delayed cure. Most recurrences occurred within 10 months postoperatively. This review of the perioperative QoL in CD helps to illustrate how QoL changes throughout the treatment process, how QoL compares to normal Canadian population levels, and how QoL compares to patients with nonfunctioning pituitary adenomas. As treatment outcome has such a high impact on QoL, the variables identified in this study will help to better inform patients about the treatment course.

Methods for assessing the reliability of quality of life based on SF-36.

The 36-Item Short Form Health Survey (SF-36) has been widely used to measure quality of life. Reliability has been traditionally assessed by intraclass correlation coefficient (ICC), which is equivalent to Cronbach's alpha theoretically. However, it is a scaled assessment of reliability and does not indicate the extent of differences because of measurement error. In this paper, total deviation index (TDI) is used to interpret the magnitude of measurement error for SF-36, and a new formula for computing TDI for average item score is proposed. The interpretation based on TDI is simple and intuitive by providing, with a high probability, the expected difference that is because of measurement error. We also show that a high value of ICC does not always correspond to a smaller magnitude of measurement error, which indicates that ICC can sometimes provide a false sense of high reliability. The methodology is illustrated with reported SF-36 data from the literature and from real data in the Arthritis Self-Management Program. Copyright © 2016 John Wiley & Sons, Ltd.