Effects of Intravenous Golimumab on Health-Related Quality of Life in Patients with Ankylosing Spondylitis: 28-Week Results of the GO-ALIVE Trial

ObjectiveEvaluate the effect of intravenous golimumab on health-related quality of life (HRQoL) in patients with ankylosing spondylitis (AS) through week 28 of the phase III, multicenter, randomized, double-blind, placebo-controlled GO-ALIVE study.MethodsAdult patients (n = 208) were randomized to IV golimumab 2 mg/kg (n = 105) at weeks 0, 4, and 12 and every 8 weeks or placebo (n = 103) at weeks 0, 4, and 12, with crossover to golimumab 2mg/kg at weeks 16, 20, and every 8 weeks. General HRQoL was evaluated using the Short Form Health Survey (SF-36) Physical Component Summary/Mental Component Summary (PCS/MCS), and the EQ VAS, and AS disease–specific HRQoL was assessed using the Ankylosing Spondylitis Quality of Life (ASQoL) instrument.ResultsMean improvements from baseline in SF-36 PCS were greater in the golimumab group versus the placebo group at weeks 8 and 16 (6.8 vs 2.1 and 8.5 vs 2.9, respectively; P < .001); similar results were observed for SF-36 MCS (5.6 vs 1.7 and 6.5 vs 0.8, respectively; P < .001). Mean improvement in each of 8 subscale scores of the SF-36 were also greater for golimumab-treated patients versus placebo at weeks 8 and 16. Mean improvements in EQ VAS and ASQoL were greater in the golimumab group versus placebo at week 8 and week 16. Greater proportions of golimumab-treated patients had clinically meaningful improvement in SF-36 PCS, SF-36 MCS, EQ VAS, and ASQoL at weeks 8 and 16; improvements in SF-36 PCS/MCS, EQ VAS, and ASQoL were maintained through week 28.ConclusionsGolimumab-treated patients had greater mean improvements in HRQoL measures compared with placebo through week 16. Clinically meaningful improvements were observed as early as week 8 and continued through week 28.     

Use of the Short Form-36 to Detect the Influence of Upper Gastrointestinal Disease on Self-Reported Health Status

Patient-centred outcome measures such as the Short Form-36 (SF-36) have been developed to assess the impact of ill health and medical interventions on self-reported health status. The objective of the study was to assess the impact of gastrointestinal disease upon health status as measured by the SF-36 physical and mental health component scores (PCS and MCS) and to assess whether these component scores might be an appropriate outcome measure for use in clinical research in gastroenterology. The subjects were 364 patients aged between 18 and 64 years who had been prescribed proton pump inhibitors (PPIs) by general practitioners in Oxfordshire. The general practices participating identified patients who had been prescribed PPIs. The data were abstracted from the general practice medical records of these patients concerning gastrointestinal diagnoses and other prescribed medications. The patients were sent the SF-36 questionnaire by post and the PCS and MCS scores were derived, which were adjusted for age and sex and compared with the scores of the general population of the Oxford region. Co-morbidity was assessed by the extent to which non-gastric medications were also used. The commonest diagnoses were oesophagitis/gastro-oesophageal reflux and indigestion. People with these diagnoses had significantly lower health status than the general population. Differences persisted when the results were controlled for the possible effects of co-morbidity. It was concluded that the SF-36 is sensitive to the impact of gastrointestinal disease on health status. This revised version was published online in June 2006 with corrections to the Cover Date.     

Assessment of Reliability and Validity of SF-12v2 among a Diabetic Population

Objectives

To validate the Medical Outcomes Study Short Form version 2 (SF-12v2) in diabetic patients.

Normative data of the SF-12 health survey with validation using postmyocardial infarction patients in the Dutch population

Objective  To gain Dutch population norms for the Short Form-12 (SF-12), a generic health status questionnaire, in a random sample of the general population and to validate these in postmyocardial infarction (MI) patients. Methods  2,301 respondents from the general population and 459 post-MI patients completed the Short Form-36 (SF-36), which was used to calculate SF-12 scores. Results  The SF-12 summary scores correlated highly with SF-36 summary scores, demonstrating that these scores explain the same amount of variance in health status. Significant sex differences (P < .001) existed for both the physical component summary (PCS) and the mental component summary (MCS). Multivariate analysis of variance showed a main effect of age in oblique (PCS-12: P < .001; MCS-12: P < .001) and orthogonally rotated PCS scores (PCS-12_uc: P < .001; MCS-12_uc: P = .07). As expected, post-MI patients reported statistically significant and clinically relevant poorer mental (P < .001) and physical functioning (P < .001). Differences were less pronounced for MCS and PCS derived from orthogonal rotation data. When controlling for covariates, MI did not significantly affect PCS-12_uc anymore in orthogonally rotated data, while PCS-12_uc was affected by fewer covariates compared with PCS-12. Conclusions  This study presents Dutch population norms for the SF-12 in a large random population sample obtained from both oblique and orthogonal PCA rotation methods, revealing systematic differences between the results based on these two methods. Furthermore, this study demonstrates the discriminative validity of the SF-12 by showing that post-MI patients differ significantly from the normative population on PCS-12 scores.     

Does Compliance with Nutrition Guidelines Lead to Healthy Aging? A Quality-of-Life Approach

ObjectivesWe aimed to estimate, in a large French cohort of middle-aged adults derived from the Supplémentation en Vitamines et Minéraux Antioxydants trial, the association of compliance with the guidelines of the French Nutrition and Health Program (PNNS) assessed at inclusion and change in health-related quality of life (HRQoL) over 12 years. A secondary objective was to identify the relative contribution of diet and physical activity to long-term change in HRQoL.Design/subjectsSubjects were Supplémentation en Vitamines et Minéraux Antioxydants trial participants aged 45 to 60 years at inclusion in the cohort.Main outcome measuresCompliance with nutrition guidelines (diet and physical activity) was assessed by the PNNS Guideline Score (maximum 15 points) at inclusion. HRQoL was measured by the Medical Outcomes Survey Short Form 36 (SF-36) at 1 year (initial measurement) and 13 years (final measurement) after inclusion. The primary end point was change in the SF-36 physical component summary (PCS) and mental component summary (MCS) scores over 12 years.ResultsIn total, 3,005 subjects (mean age 51.4±4.3 years) completed the SF-36 at the initial and final measurement. The mean PNNS Guideline Score was 7.8±1.9 and the mean PCS and MCS was 52.2±6.4 and 50.3±7.0, respectively, at the initial measurement and 48.0±9.6 and 51.2±8.7 at the final measurement. Better compliance with nutritional guidelines was associated with better initial and final HRQoL but not associated with change in HRQoL. Compliance with dietary guidelines was associated with positive change in PCS score but not associated with initial PCS score. In contrast, compliance with dietary guidelines was related to positive initial MCS score but not related to change in MCS score. Compliance with physical activity guidelines was related to initial PCS and MCS scores but not related to change in PCS and MCS scores.ConclusionsFollowing physical activity guidelines may be associated with better concomitant HRQoL and following dietary guidelines with better future physical HRQoL.     

Multidimensional item response theory models yielded good fit and reliable scores for the Short Form-12 questionnaire

ObjectivesTo propose a multidimensional item response theory (MIRT) scoring system for the Short Form 12 (SF-12) with good psychometric properties in terms of fit and reliability.Study Design and SettingsTwo models, indicating physical (PCS) and mental component summary (MCS) dimensions, were fitted to SF-12 data from the European Study of the Epidemiology of Mental Disorders, a representative sample from European adult general population (n = 21,425; response rate = 61.2%). Goodness of fit, information, reliability, and agreement of individual scores were compared with the classical SF-12 and RAND-12 algorithms.ResultsThe bidimensional response process (BRP) model, where all items are indicators of both dimensions, yielded the best fit (root mean square error of approximation = 0.057, comparative fit index = 0.95, and Tucker–Lewis index = 0.94), and highly agreed with PCS and MCS scores from the SF-12 (intraclass correlation coefficients of 0.92 and 0.88, respectively) and RAND-12 (0.88 and 0.95). Regarding reliability, the BRP yielded 0.75 and 0.77 (PCS and MCS, respectively), greater than SF-12 (0.65 and 0.66) and RAND-12 (0.65 and 0.67). As indicated by scale linking, MIRT scores can be interpreted similarly to the classical scores.ConclusionThe MIRT models showed a clear construct structure for the PCS and MCS dimensions, defined by functional and role limitation content. Results support the use of SF-12 MIRT-based scores as a valid and reliable option to assess health status.     

Improvement in Eating Disorder Risk and Psychological Health in People with Class 3 Obesity: Effects of a Multidisciplinary Weight Management Program

This study aimed to evaluate the risk of eating disorders, psychological distress, and health-related quality of life (HRQoL) in people with class 3 obesity (body mass index (BMI) ≥ 40 kg/m²), and the effect of multidisciplinary weight management over 12 months. This retrospective cohort study included all adults with class 3 obesity who enrolled in a weight management program from March 2018 to December 2019. Questionnaires included the Eating Disorder Examination Questionnaire Short (EDE-QS), Kessler Psychological Distress Scale (K10), and 36-Item Short Form Survey (SF-36) for HRQoL. Physical and Mental Component Summary scores (PCS and MCS) were derived from the SF-36. Of 169 participants who completed 12 months in the program, 65.7% (n = 111) completed questionnaires at baseline and 12 months, with 6.0 ± 6.8% weight loss over this period. Compared to baseline, there was significant improvement at 12 months in EDE-QS (15.7 ± 6.6 vs. 13.6 ± 6.2, p = 0.002), K10 (25.7 ± 9.7 vs. 21.2 ± 9.4, p < 0.001), PCS (29.4 ± 10.1 vs. 36.1 ± 10.9, p < 0.001), and MCS scores (40.2 ± 12.4 vs. 44.0 ± 13.4, p = 0.001). All, apart from EDE-QS scores, remained significant after adjusting for weight change. This study highlights the importance of multidisciplinary management in people with class 3 obesity to help reduce eating disorder risk and psychological distress, and improve HRQoL, in addition to weight loss.     

Trajectories and associated factors of quality of life,global outcome,and post-concussion symptoms in the first year following mild traumatic brain injury

Purpose

To investigate the associated factors and change trajectories of quality of life (QoL), global outcome, and post-concussion symptoms (PCS) over the first year following mild traumatic brain injury (mTBI).

Methods

This was a prospective longitudinal study of 100 participants with mTBI from neurosurgical outpatient departments in Chiayi County District Hospitals in Taiwan. The checklist of post-concussion syndromes (CPCS) was used to assess PCS at enrollment and at 1, 3, and 12 months after mTBI; the glasgow outcome scale extended (GOSE), the quality of life after brain injured (QOLIBRI), Chinese version, and the Short Form 36 Health Survey (SF-36), Taiwan version, were used to assess mTBI global outcome and QoL at 1, 3, and 12 months after mTBI.

Results

Latent class growth models (LCGMs) indicated the change trajectories of QOLIBRI, PCS SF-36, MCS SF-36, GOSE, and PCS. Classes of trajectory were associated with age ≥40 years, unemployment at 1 month after injury, and educational level ≤12 years. Univariate analysis revealed that employment status at 1 month post-injury was correlated with the trajectories of QOLIBRI, PCS SF-36, MCS SF-36, and GOSE, but not PCS.

Conclusions

Employment status was the most crucial associated factor for QoL in individuals with mTBI at the 1-year follow-up. Future studies should explore the benefits of employment on QoL of individuals with mTBI.

     

Effects of Intravenous Golimumab on Health-Related Quality of Life in Patients With Psoriatic Arthritis: 24-Week Results of the GO-VIBRANT Trial

ObjectivesEvaluate the effects of intravenous golimumab 2 mg/kg on multiple domains of health-related quality of life (HRQoL) in adult patients with active psoriatic arthritis (PsA).MethodsIn this phase III, randomized, double-blinded, placebo-controlled study, adults with active PsA were randomized in a 1:1 ratio to receive intravenous (IV) infusions of placebo (n = 239) or golimumab 2 mg/kg (n = 241) at weeks 0, 4, 12, and 20. Physical function was assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI). HRQoL was assessed using the 36-item Short-Form Health Survey Physical and Mental Component Summary (SF-36 PCS/MCS) scores, the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue, EQ VAS, and the Dermatology Life Quality Index (DLQI).ResultsPatients in the golimumab group had greater mean changes from baseline in HAQ-DI compared with placebo at weeks 8 (−0.52 vs −0.10), 14 (−0.60 vs −0.12), and 24 (−0.63 vs −0.14). Mean improvements from baseline in SF-36 PCS (8.0 vs 1.7), SF-36 MCS (5.0 vs 1.2), EQ VAS (17.2 vs 3.7), FACIT-Fatigue (7.9 vs 2.0), and DLQI (−7.2 vs −1.7) were also greater in the golimumab group versus placebo at week 8 and were maintained or increased through week 24. Greater proportions of golimumab-treated patients had improvements greater than or equal to the minimal clinically important difference (MCID) for HAQ-DI, SF-36 PCS/MCS, EQ VAS, FACIT-Fatigue, and DLQI scores at weeks 14 and 24.ConclusionImprovements in HRQoL were greater in the IV golimumab group compared with placebo and were evident at week 8 and sustained through week 24.     

Is the standard SF-12 Health Survey valid and equivalent for a Chinese population?

Introduction: Chinese is the worlds largest ethnic group but few health-related quality of life (HRQoL) measures have been tested on them. The aim of this study was to determine if the standard SF-12 was valid and equivalent for a Chinese population. Methods: The SF-36 data of 2410 Chinese adults randomly selected from the general population of Hong Kong (HK) were analysed. The Chinese (HK) specific SF-12 items and scoring algorithm were derived from the HK Chinese population data by multiple regressions. The SF-36 PCS and MCS scores were used as criteria to assess the content and criterion validity of the SF-12. The standard and Chinese (HK) specific SF-12 PCS and MCS scores were compared for equivalence. Results: The standard SF-12 explained 82% and 89% of the variance of the SF-36 PCS and MCS scores, respectively, and the effect size differences between the standard SF-36 and SF-12 scores were less than 0.3. Six of the Chinese (HK) specific SF-12 items were different from those of the standard SF-12, but the effect size differences between the Chinese (HK) specific and standard SF-12 scores were mostly less than 0.3. Conclusions: The standard SF-12 was valid and equivalent for the Chinese, which would enable more Chinese to be included in clinical trials that measure HRQoL.     

Psychometric properties of the Neck OutcOme Score,Neck Disability Index,and Short Form–36 were evaluated in patients with neck pain

ObjectiveTo assess reliability, construct validity, responsiveness, and interpretability for Neck OutcOme Score (NOOS), Neck Disability Index (NDI), and Short Form–36 (SF-36) in neck pain patients.Study Design and SettingInternal consistency was assessed by Cronbach alpha. Test-retest reliability was evaluated by intraclass correlation coefficient (ICC), and measurement error was estimated from the standard error of measurement. Responsiveness was assessed as standardized response mean (SRM) and interpretability from the minimal important difference (MID). Construct validity was tested correlating subscale scores from NOOS and SF-36 and NDI items.ResultsAt baseline, 196 neck pain patients were included. Cronbach α was adequate for most NOOS subscales, NDI, and SF-36 with few exceptions. Good to excellent reliability was found for NOOS subscales (ICC 0.88–0.95), for NDI, and for SF-36 with few exceptions. For NOOS, minimal detectable changes varied between 1.1 and 1.9, and construct validity was supported. SRMs were higher for NOOS subscales (0.19–0.42), compared to SF-36 and NDI. MID values varied between 15.0 and 24.1 for NOOS subscales.ConclusionsIn conclusion, the NOOS is a reliable, valid, and responsive measure of self-reported disability in neck pain patients, performing at least as well or better than the commonly used SF-36 and NDI.     

Correlations between disease-specific and generic health status questionnaires in patients with advanced COPD: a one-year observational study

ABSTRACT: BACKGROUND: Longitudinal studies analyzing the correlations between disease-specific and generic questionnaires at different time points in patients with advanced COPD are lacking. The aim of this study was to determine whether and to what extent a disease-specific health status questionnaire (Saint George's Respiratory Questionnaire, SGRQ) correlates with generic health status questionnaires (EuroQol-5-Dimensions, EQ-5D; Assessment of Quality of Life instrument, AQoL; Medical Outcomes Study 36-Item Short-Form Health Survey, SF-36) at four different time points in patients with advanced COPD; and to determine the correlation between the changes in these questionnaires during one-year follow-up. METHODS: Demographic and clinical characteristics were assessed in 105 outpatients with advanced COPD at baseline. Disease-specific health status (SGRQ) and generic health status (EQ-5D, AQoL, SF-36) were assessed at baseline, four, eight, and 12 months. Correlations were determined between SGRQ and EQ-5D, AQoL, and SF-36 scores and changes in these scores. Agreement in direction of change was assessed. RESULTS: Eighty-four patients (80%) completed one-year follow-up and were included for analysis. SGRQ total score and EQ-5D index score, AQoL total score and SF-36 Physical Component Summary measure (SF-36 PCS) score were moderately to strongly correlated. The correlation of the changes between the SGRQ total score and EQ-5D index score, AQoL total score, SF-36 PCS, and SF-36 Mental Component Summary measure (SF-36 MCS) score were weak or absent. The direction of changes in SGRQ total scores agreed slightly with the direction of changes in EQ-5D index score, AQoL total score, and SF-36 PCS score. CONCLUSIONS: At four, eight and 12 months after baseline, SGRQ total scores and EQ-5D index scores, AQoL total scores and SF-36 PCS scores were moderately to strongly correlated, while SGRQ total scores were weakly correlated with SF-36 MCS scores. The correlations between changes over time were weak or even absent. Disease-specific health status questionnaires and generic health status questionnaires should be used together to gain complete insight in health status and changes in health status over time in patients with advanced COPD.     

Validation testing of a three-component model of Short Form-36 scores

Objective

The two-component factor structure underlying Short Form-36 (SF-36) summary scores may not be valid worldwide. We studied a three-component model of SF-36 scores in Japan.

Study Design and Setting

The SF-36 scores came from representative samples of the population of Japan. Factor analysis and structural equation modeling were used. The two-component model gave physical component summary (PCS) scores and mental component summary (MCS) scores. The three-component model gave scores on the PCS, the MCS, and also on the third component, which we call the role component summary (RCS) score. These were evaluated with external criteria.

Results

In the three-component model, the RCS was strongly associated with the role-physical, social functioning, and role-emotional subscales, whereas the PCS and MCS were associated with the physical functioning and mental health subscales, as expected. The goodness-of-fit index was 0.945 for the three-component model and 0.935 for the two-component model. The PCS discriminated between groups stratified by comorbid conditions, and the MCS discriminated between groups stratified by psychological depression. Absence from work was associated with both PCS and RCS.

Conclusion

The three-component model is better than the two-component model, and it provides more useful PCS and MCS scores. Criteria for validation testing of the RCS are needed.     

Responsiveness of the short musculoskeletal function assessment (SMFA) in patients with femoral neck fractures

Purpose  

The aim of this study was to evaluate the internal and external responsiveness of the Short Musculoskeletal Function Assessment (SMFA), i.e. the instrument’s ability to capture clinically important changes, in patients with hip fractures within the context of a randomized controlled trial.     

Results from several population studies show that recommended scoring methods of the SF-36 and the SF-12 may lead to incorrect conclusions and subsequent health decisions

Purpose

To compare the measurement properties of the physical component summary (PCS) and mental component summary (MCS) scores of the SF-36 and SF-12 based on the traditional orthogonal scoring algorithms with the performance of the PCS and MCS scored based on structural equation model coefficients from a correlated model.

Methods

This study used three large-scale representative population studies to compare the measurement properties of the PCS and MCS scores of the SF-36 and SF-12 with the performance of the PCS and MCS scores based on structural equation models producing coefficients from a correlated model. We assessed the relationships of these scores with selected important mental health measures and chronic conditions from three representative Australian population studies that address clinical conditions of high prevalence and health service importance.

Results

Structural equation model scoring methods produced summary scores with higher correlations than the recommended orthogonal methods across a range of disease and health conditions. The problem experienced in using the orthogonal methods is that negative scoring coefficients are applied to negative z-scores for sub-scales, inflating the resulting summary scores. Effect sizes over a half of a standard deviation were common.

Conclusions

If health policy or investment decisions are made based on the results of studies employing the recommended orthogonal scoring methods then the expected outcome of such decisions or investments may not be achieved.     

Relationship between Vitamin Intake and Health-Related Quality of Life in a Japanese Population: A Cross-Sectional Analysis of the Shika Study

Although epidemiological studies revealed a relationship between psychosocial states, such as depressive symptoms, and nutritional intake, limited information is currently available on vitamin intake. The Short Form-36 Health Survey (SF-36) is not limited to a specific disease, it is constructed based on a universal concept of health and is used to evaluate the Quality of life (QOL). A three-component scoring method was developed for “Physical component score (PCS)”, “Mental component score (MCS)”, and “Role/social score (RCS)”. Collectively, these summary scores are called the “QOL summary score”, which is regarded as a more detailed health summary score. In the present study, we aimed at epidemiologically examine the relationship between vitamin intake and QOL in middle-aged and elderly population in 3162 residents in Japan. In women, a multiple regression analysis showed a positive correlation between all vitamin intake and PCS scores, and between vitamin B6, folic acid, vitamin C, and MCS scores. In consideration of depression as MCS of SF-36 and chronic pain as PCS, an insufficient vitamin intake may affect QOL in women; however, a causal relationship has not yet been demonstrated.     

Dimensionality and Summary Measures of the SF-36 v1.6: Comparison of Scale- and Item-Based Approach Across ECRHS II Adults Population

ObjectivesThe objective of this study was twofold: 1) to confirm the hypothetical eight scales and two-component summaries of the questionnaire Short Form 36 Health Survey (SF-36), and 2) to evaluate the performance of two alternative measures to the original physical component summary (PCS) and mental component summary (MCS).MethodsWe performed principal component analysis (PCA) based on 35 items, after optimal scaling via multiple correspondence analysis (MCA), and subsequently on eight scales, after standard summative scoring. Item-based summary measures were planned. Data from the European Community Respiratory Health Survey II follow-up of 8854 subjects from 25 centers were analyzed to cross-validate the original and the novel PCS and MCS.ResultsOverall, the scale- and item-based comparison indicated that the SF-36 scales and summaries meet the supposed dimensionality. However, vitality, social functioning, and general health items did not fit data optimally. The novel measures, derived a posteriori by unit-rule from an oblique (correlated) MCA/PCA solution, are simple item sums or weighted scale sums where the weights are the raw scale ranges. These item-based scores yielded consistent scale-summary results for outliers profiles, with an expected known-group differences validity.ConclusionsWe were able to confirm the hypothesized dimensionality of eight scales and two summaries of the SF-36. The alternative scoring reaches at least the same required standards of the original scoring. In addition, it can reduce the item-scale inconsistencies without loss of predictive validity.     

Psychometric evaluation of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument: validity,responsiveness, and identification of the minimally important difference in a phase 2 clinical trial

Purpose

To describe the psychometric properties and identify the minimally important difference (MID) of the hepatitis C virus patient-reported outcomes (HCV-PRO) instrument. Chronic HCV infection and associated treatments negatively affect PROs of function and well-being.

Methods

In a phase 2 trial, HCV-infected patients received direct-acting antivirals (DAAs) for 12 weeks with peg-interferon/ribavirin (peg-IFN/RBV) for 48 weeks, or placebo plus peg-IFN/RBV. The HCV-PRO total score, SF-36 PCS and MCS scores, EQ-5D-3L, and EQ VAS were measured at baseline, week 8, end of DAA treatment (EODT), end of peg-IFN/RBV treatment (EOT), and posttreatment week 24 (SVR₂₄). Convergent validity of the HCV-PRO was assessed by Pearson’s correlation coefficients. Discriminant validity was assessed by analyzing mean HCV-PRO total scores by EQ-5D anxiety/depression and pain/discomfort domain scores (none vs. some) and presence/absence of depression or fatigue adverse events. MID was identified through effect size (ES) and receiver-operating characteristic (ROC) curve analyses (HCV-PRO response vs. SF-36 PCS/MCS and EQ VAS MID thresholds).

Results

In 74 patients (22 % female; 81 % White; 51 % ≥50 years), correlations (0.64–0.96) between HCV-PRO total scores, SF-36 PCS/MCS scores, and EQ VAS scores at all time points supported convergent validity. HCV-PRO total scores were reduced to 10–30 points in patients impaired by depression, pain, or fatigue symptoms. Impact of peg-IFN/RBV regimen on HCV-PRO ES increased over time (EODT ?0.76; EOT ?0.93). ES and ROC curve analyses indicated an MID of ?10 points.

Conclusion

The HCV-PRO was valid and responsive in the population studied. An MID of ?10 points represented a threshold of clinical significance for the HCV-PRO.     

Health-related quality of life in patients with interstitial cystitis/bladder pain syndrome and frequently associated comorbidities

Purpose

To estimate the association of chronic non-urologic conditions [i.e., fibromyalgia (FM), chronic fatigue syndrome (CFS), and irritable bowel syndrome (IBS)] with health-related quality of life (HRQOL) in patients with interstitial cystitis/bladder pain syndrome (IC/BPS).

Methods

A total of 276 women with established diagnoses of IC/BPS completed a telephone interview which included demographics, self-reported medical conditions, the SF-36 health survey, and the interstitial cystitis symptom index (ICSI). Multivariate linear regression analysis was used to identify correlates of SF-36 physical and mental component summary scores.

Results

Mean patient age was 45.1 (SD 15.9) years, and 83 % of the subjects were white. Mean values for the SF-36 Physical Component Score (PCS) and Mental Component Score (MCS) means were 39 (SD 14) and 45 (SD 12), respectively, indicating significant HRQOL reductions. Mean ICSI score was 11.27 (SD = 4.86). FM and IBS were significantly associated with worse SF-36 scores: ?8 points on the PCS (p < 0.001) and ?6 points on the MCS (p < 0.001). CFS and the presence of other pelvic conditions (overactive bladder, vulvodynia, endometriosis) were not significantly associated with SF-36 PCS and MCS scores.

Conclusions

In patients with IC/BPS, the presence of FM, CFS, and IBS has a significant association with HRQOL, equivalent in impact to the bladder symptoms themselves. These results emphasize the importance of a multidisciplinary approach to treating patients with IC/BPS and other conditions.     

Predicting an SF-6D Preference-Based Score Using MCS and PCS Scores from the SF-12 or SF-36

Background:  The SF-6D preference-based scoring system was developed several years after the SF-12 and SF-36 instruments. A method to predict SF-6D scores from information in previous reports would facilitate backwards comparisons and the use of these reports in cost-effectiveness analyses.
Methods:  This report uses data from the 2001–2003 Medical Expenditures Panel Survey (MEPS), the Beaver Dam Health Outcomes Survey, and the National Health Measurement Study. SF-6D scores were modeled using age, sex, mental component summary (MCS) score, and physical component summary (PCS) score from the 2002 MEPS. The resulting SF-6D prediction equation was tested with the other datasets for groups of different sizes and groups stratified by age, MCS score, PCS score, sum of MCS and PCS scores, and SF-6D score.
Results:  The equation can be used to predict an average SF-6D score using average age, proportion female, average MCS score, and average PCS score. Mean differences between actual and predicted average SF-6D scores in out-of-sample tests was −0.001 (SF-12 version 1), −0.013 (SF-12 version 2), −0.007 (SF-36 version 1), and −0.010 (SF-36 version 2). Ninety-five percent credible intervals around these point estimates range from ±0.045 for groups with 10 subjects to ±0.008 for groups with more than 300 subjects. These results were consistent for a wide range of ages, MCS scores, PCS scores, sum of MCS and PCS scores, and SF-6D scores. SF-6D scores from the SF-36 and SF-12 from the same data set were found to be substantially different.
Conclusions:  Simple equation predicts an average SF-6D preference-based score from widely published information.