SF-36v2 Mental Component Summary Research Articles

OR10-05 Improved Mental And Psychosocial Patient-Reported Outcomes Among People With Obesity Treated With Tirzepatide: Results From SURMOUNT-1 Study

Abstract Disclosure: J. Poon: Employee; Self; Eli Lilly & Company. Stock Owner; Self; Eli Lilly & Company. S. Zhang: Employee; Self; Eli Lilly & Company. Stock Owner; Self; Eli Lilly & Company. H. Kan: Employee; Self; Eli Lilly & Company. Stock Owner; Self; Eli Lilly & Company. M.C. Bunck: Employee; Self; Eli Lilly & Company. Stock Owner; Self; Eli Lilly & Company. J. Dunn: Employee; Self; Eli Lilly & Company. Stock Owner; Self; Eli Lilly & Company. A. Stefanski: Employee; Self; Eli Lilly & Company. Stock Owner; Self; Eli Lilly & Company. M. Murphy: Employee; Self; Eli Lilly & Company. Stock Owner; Self; Eli Lilly & Company. Background: Living with obesity negatively impacts a person’s mental health and psychosocial function, leading to impaired health-related quality of life (HRQoL). Tirzepatide resulted in clinically sustained reductions in body weight among participants with obesity in SURMOUNT-1, a Phase 3 randomized clinical trial. To determine the impact of tirzepatide treatment on mental health and psychosocial function, changes in HRQoL were assessed in SURMOUNT-1 using the Short Form 36 health survey version 2 acute form (SF-36v2) and the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT). Methods: A total of 2,539 participants were included in the study (tirzepatide 5 mg, N=630; 10 mg, N=636; 15 mg, N=630; placebo, N=643). The SF-36v2 (36 items) and IWQOL-Lite-CT (20 items) were collected at both baseline and endpoint of primary treatment period (week 72 or early discontinuation, where last observation was carried forward (LOCF)). The SF-36v2 assesses eight domains of HRQoL including role-emotional and mental health, and yields two additional summary scores, including the Mental Component Summary (MCS) score. SF-36v2 scores are norm-based with mean (SD) 50 (10). IWQOL-Lite-CT assesses three primary composites, including 13-item psychosocial composite score. IWQOL-Lite-CT composite scores were transformed to a scale of 0 to 100. Higher scores of both SF-36v2 and IWQOL-Lite-CT indicates better levels of health and psychosocial function. Estimated mean change from baseline to week 72 for SF-36v2 (norm-based) and IWQOL-Lite-CT composite (transformed) scores were analyzed using an analysis of covariance (ANCOVA) model. Results: Mean scores at baseline for tirzepatide 5, 10, 15 mg doses and placebo for SF-36v2 role-emotional were 50.7, 51.0, 50.5, and 50.8, respectively, and for mental health were 53.4, 54.0, 53.4, and 53.4, respectively. Mean MCS scores at baseline for tirzepatide 5, 10, 15 mg doses and placebo were 53.3, 53.8, 53.4, and 53.5, respectively. Mean scores at baseline for tirzepatide 5, 10, 15 mg doses and placebo for IWQOL-Lite-CT psychosocial composite score were 64.3, 62.1, 63.2, and 63.2, respectively. All doses of tirzepatide showed significant improvements at week 72 compared to placebo for both SF-36v2 and IWQOL-Lite-CT scores (p<0.05). Estimated mean change from baseline to week 72 with tirzepatide 5, 10, 15 mg doses versus placebo were as follows: SF-36v2 role-emotional scores, 1.7, 1.3, and 1.8, versus 0.3 (p<0.05); SF-36v2 mental health scores 0.8, 0.8, and 1.1, versus -0.2 (p<0.05); SF-36v2 MCS scores were 0.7, 0.4, and 0.7 versus -0.5 (p<0.05); IWQOL-Lite-CT psychosocial scores 19.6, 22.1, and 23.6 versus 11.0 (p<0.001). Conclusion: In SURMOUNT-1, tirzepatide demonstrated statistically significant improvements in patient-reported mental health and psychosocial function as assessed by SF-36v2 and IWQOL-Lite-CT, compared to placebo. Presentation: Friday, June 16, 2023

Long-term quality of life assessment after excisional treatment for cervical dysplasia

We evaluated factors influencing long-term health-related quality of life (HRQoL) after excisional treatments of low- and high grade squamous intraepithelial cervical lesions (SIL) in three groups of women (n = 160): nulliparas interested in reproduction (A), parous women interested in reproduction (B) and women without pregnancy desire (C). The HRQoL was assessed using the disease-specific FACIT-CD and the generic SF36v2 questionnaires. Anxiety and depression were evaluated by Beck’s inventories. After median follow-up of 5 (2–18) years, FACIT-CD total score and the score for Emotional Well-Being (EWB) were significantly lower in group A. The total, EWB and REL (Relationships) scores of FACIT-CD were the highest in group B. Women operated for HSIL demonstrated lower REL quality in comparison to those with LSIL. Neither SF36v2 nor FACIT-CD total scores differed in relation to SIL grade or type of excision. ‘SF36v2 Mental Component Summary Score’ and ‘being parous and interested in fertility’ were independent predictors of disease-specific FACIT-CD score. Impact Statement What is already known on this subject? Long-term consequences of excisional treatments for cervical dysplasia on health-related quality of life (HRQoL) are not well reported. What do the results of this study add? Our study provides data on HRQoL in women treated with large loop excision of the transformation zone (LLETZ) or cold knife conization (CKC) obtained during the longest (median 5 years) follow-up as reported to date. We were able to show that having children and planning further pregnancies positively influenced HRQoL in these patients. In addition, we identified nulliparas with pregnancy desire as psychologically the most vulnerable group within the studied cohort. What are the implications of these findings for clinical practice and/or further research? Even several years after LLETZ or CKC, women may suffer from impaired Emotional Well-Being and reduced HRQoL. Awareness and assessment of these long-term consequences should be part of surveillance after excisional treatments for cervical dysplasia.

Achieving clinical response in postpartum depression leads to improvement in health-related quality of life

Objective To evaluate the health-related quality of life (HRQoL) burden associated with postpartum depression (PPD), determine the extent to which clinical response impacts HRQoL, and estimate the impact of PPD and clinical response on healthcare resource utilization (HRU) and productivity. Methods Patient data (n = 127) from two multicenter, randomized, double-blind, placebo-controlled phase 3 clinical trials evaluating the safety and efficacy of brexanolone injection in adults with PPD were employed for these posthoc analyses. HRQoL and health utility was assessed with the SF-36-v2 Health Survey (SF-36v2) acute version. The 17-item Hamilton Rating Scale for Depression (HAMD-17) total score was used to identify clinical response (≥50% reduction in HAMD-17 total score). Baseline HRQoL burden was assessed by comparison to age- and gender-adjusted population normative data from the 2009 QualityMetric PRO Norming study. The impact of clinical response was evaluated by comparing day 7 and day 30 SF-36v2 scores between clinical responders and non-responders. Interpretations of the meaningfulness of clinical response were indirectly estimated via 2017 National Health and Wellness Survey data linking SF-36v2 mental component summary (MCS) scores to (HRU) and productivity. Results Baseline HRQoL of patients with PPD was significantly below normative values. Day 7 and day 30 clinical response were associated with large and statistically significant improvements in HRQoL, greater likelihood of meeting SF-36v2 responder definitions, and reduced impairment. MCS levels corresponding to those observed in clinical responders were linked to lower HRU and productivity loss relative to non-responders. Conclusions PPD places a substantial burden on HRQoL. Achievement of rapid clinical response (at day 7) and clinical response sustained several weeks following the end of treatment (day 30) led to significant improvement in HRQoL, suggesting the importance of identifying women with PPD and providing effective treatment options.

Long-term effect of aripiprazole lauroxil on health-related quality of life in patients with schizophrenia

BackgroundThis post hoc analysis of clinical trial data evaluated long-term, self-reported mental and physical health-related quality of life (HRQoL) scores in schizophrenia patients receiving aripiprazole lauroxil (AL), an atypical long-acting injectable (LAI) antipsychotic approved for the treatment of schizophrenia in adults.MethodsThe study population included 291 stable schizophrenia outpatients enrolled in 2 consecutive long-term safety studies of AL given every 4 weeks for up to 124 weeks. HRQoL was measured using the SF-36v2® Health Survey (SF-36v2) over the course of the follow-up. The primary outcome was change in SF-36v2 mental component summary (MCS) and physical component summary (PCS) scores from baseline to 124 weeks. To contextualize these scores, descriptive analyses were conducted to compare the scores with available scores for the general population as well as for other populations with chronic medical (ie, hypertension and type 2 diabetes) or psychiatric (ie, depression) conditions.ResultsResults from this post hoc analysis indicated that the mean MCS score for patients continuing AL improved significantly from baseline over 124 weeks (P < .05, all timepoints), while mean PCS score showed little change over 124 weeks. At baseline, patients had lower (worse) MCS scores than the normed general population, but by week 124, patients had MCS scores comparable to those in the general population. This pattern of change was not observed with PCS scores. Comparison of study MCS scores with those associated with other diseases showed that this schizophrenia cohort had lower scores than those with chronic medical conditions but higher scores than those with depression. PCS scores were higher in the study population than published scores for all reference populations at baseline and week 124.ConclusionsIn this post hoc analysis, outpatients with schizophrenia who continued the LAI antipsychotic AL showed gradual and sustained improvement in self-reported mental HRQoL over several years of follow-up, whereas self-reported physical HRQoL did not change. By the end of follow-up, mental health scores of study patients with schizophrenia were comparable to those of the general population and better than those of patients with depression.Trial registrationClinicalTrials.gov (NCT01626456 [trial registration date: June 15, 2012] and NCT01895452 [trial registration date: July 5, 2013]).

The Health-Related Quality of Life, Work Productivity, Healthcare Resource Utilization, and Economic Burden Associated with Levels of Suicidal Ideation Among Patients Self-Reporting Moderately Severe or Severe Major Depressive Disorder in a National Survey

BackgroundSuicidal ideation (SI) is a cardinal aspect of major depressive disorder (MDD); however, patient-reported outcomes data from large-scale surveys are limited concerning SI in the context of MDD. This study aims to understand the association between varying levels of SI and health-related quality of life (HRQoL), work productivity, healthcare resource utilization (HRU), and associated costs in patients with moderately severe/severe MDD.MethodsThis was a retrospective, cross-sectional analysis of 2013 national survey data. Patients who self-reported moderately severe or severe MDD and completed the Short Form Survey Version 2 (SF-36v2), Work Productivity Loss and Activity Impairment questionnaire (WPAI), and questions related to HRU were analyzed. Direct and indirect costs were calculated. Patients were categorized and analyzed by the level of SI (no SI, low, moderate, and high) based on their response to Item 9 of the Patient Health Questionnaire-9.ResultsAmong 75,000 respondents, 15.3% self-reported receiving a physician diagnosis of moderately severe or severe MDD and 2.8% of the total sample endorsed some level of SI. Patients with high SI showed a higher burden than patients with no SI, reporting lower mean SF-36v2 mental component summary scores (p<0.001), higher work productivity loss (p=0.039), and higher numbers of per patient per month hospitalizations (p=0.002) and emergency room visits (p=0.011). High SI was associated with greater per patient per month direct costs ($1220 vs $796; p=0.002) and indirect costs ($1449 vs $1058; p=0.001) compared with no SI. When patients with low or moderate SI were compared with patients with no SI, the results were mixed.ConclusionHigher levels of SI were associated with lower HRQoL, greater HRU, and more work impairment resulting in higher direct and indirect costs compared with patients with MDD but no SI. These results highlight the need to implement effective treatment models and interventions in the employed population.

The effect of participation in a mobility clinic on self-reported mobility and quality of life in people with lower limb amputation: A pilot study.

Many people with lower limb amputation experience mobility impairment and reduced quality of life. Mobility clinics are designed to improve mobility and quality of life for people with lower limb amputation, but their effectiveness is unknown. To compare changes in mobility prior to, and 12 weeks following participation in mobility clinic for people with lower limb amputation, and to explain whether changes in mobility explained changes in quality of life. To determine whether the PLUS-M™ was sensitive to the effects of participation in the mobility clinic, and to estimate the sample size required for a definitive study. Longitudinal observational. Electronic versions of the PLUS-M and SF-36v2® were completed by people living in the community with lower limb amputation prior to, and 12 weeks following participation in a mobility clinic. There was a significant increase in mobility from baseline to 12 weeks post participation in the clinic (p = 0.012). Changes in mobility explained a significant proportion of variance in the SF-36v2 mental component summary (p = 0.024) but not the physical component summary (p = 0.804). For people with lower limb amputation, mobility increased after participation in the clinic and this explained improvements in SF-36v2 mental component summary. The PLUS-M was sensitive enough to detect a change in mobility over time. This preliminary data indicated that participation in a mobility clinic improved mobility and the mental components of quality of life for people living with lower limb amputation. The PLUS-M™ seems sensitive to changes in mobility as a result of participation in a mobility clinic.

Effects of monthly buprenorphine extended-release injections on patient-centered outcomes: A long-term study

IntroductionThe physical, social, psychological, and economic burden of opioid use disorder (OUD) is substantial. As of the year 2019, the predominant focus of OUD research was outcomes such as retention and abstinence. We report herein the effects of extended-release buprenorphine (BUP-XR), the first FDA-approved subcutaneously injected, monthly treatment for OUD, on patient-centered outcomes. Materials and methodsPatient-centered outcomes were collected during an open-label safety study of participants with OUD (NCT# 02510014) evaluating BUP-XR. Measures collected during the study included the EQ-5D-5L, SF-36v2, Treatment Effectiveness Assessment (TEA), Addiction Severity Index-Lite (ASI-Lite), employment/insurance status questionnaire, and Medication Satisfaction Questionnaire (MSQ). Changes from baseline to end of study week 49 were analyzed using mixed models for repeated measures. “Baseline” was defined as the value collected prior to the first BUP-XR injection. Results presented are for those participants who initiated treatment on BUP-XR during the open-label study and were eligible to receive up to 12 injections. ResultsFour hundred twelve participants were included in analyses; 206 participants discontinued BUP-XR prematurely. Mean EQ-5D-5L scores remained stable from baseline to end of study. Statistically significant improvements from baseline to end of study were noted for the SF-36v2 mental component summary score (difference = 5.0, 95%CI: 3.5–6.5) and 7 of 8 domain scores (P < .05 for all comparisons); the SF-36v2 physical component summary remained stable from baseline to end of study. The TEA total score (difference = 9.3 points, 95%CI: 8.0–10.5) and 4 of 4 domain scores (difference = 2–3 points per domain) significantly improved from baseline to end of study. Significant improvements (P < .05 for all comparisons) on the ASI-Lite were seen for all problem areas except alcohol use from baseline to end of study. Employment rate increased 7% whereas health insurance status remained stable from baseline to end of study. Medication satisfaction measured using the MSQ was >88% at end of study. ConclusionsTreatment with BUP-XR monthly injections for up to 12 months in this cohort of treatment-seeking individuals with OUD led to positive PCOs and high treatment satisfaction, which correspond to personal recovery.

Survivors of an Acute Coronary Syndrome With Lower Patient Activation Are More Likely to Experience Declines in Health-Related Quality of Life.

Patient activation comprises the knowledge, skills, and confidence for self-care and may lead to better health outcomes. We examined the relationship between patient activation and changes in health-related quality of life (HRQOL) after hospitalization for an acute coronary syndrome (ACS). We studied patients from 6 medical centers in central Massachusetts and Georgia who had been hospitalized for an ACS between 2011 and 2013. At 1 month after hospital discharge, the patients completed the 6-item Patient Activation Measure and were categorized into 4 levels of activation. Multinomial logistic regression analyses compared activation level with clinically meaningful changes (≥3.0 points, generic; ≥10.0 points, disease-specific) in generic physical (SF-36v2 Physical Component Summary [PCS]), generic mental (SF-36v2 Mental Component Summary [MCS]), and disease-specific (Seattle Angina Questionnaire [SAQ]) HRQOL from 1 to 3 and 1 to 6 months after hospitalization, adjusting for potential sociodemographic and clinical confounders. The patients (N = 1042) were, on average, 62 years old, 34% female, and 87% non-Hispanic white. A total of 10% were in the lowest level of activation. The patients with the lowest activation had 1.95 times (95% confidence interval, 1.05-3.62) and 2.18 times (95% confidence interval, 1.17-4.05) the odds of experiencing clinically significant declines in MCS and SAQ HRQOL, respectively, between 1 and 6 months than the most activated patients. The patient activation level was not associated with meaningful changes in PCS scores. Hospital survivors of an ACS with lower activation may be more likely to experience declines in mental and disease-specific HRQOL than more-activated patients, identifying a group at risk of poor outcomes.

Patient-Reported Health-Related Quality of Life Improves over Time in Patients with Chronic Immune Thrombocytopenia Receiving Long-Term Treatment with Eltrombopag

Background: EXTEND (June 2006 to July 2015) was an open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for the treatment of patients with chronic immune thrombocytopenia (cITP) who had previously been enrolled in an eltrombopag trial. CITP may lead to fatigue and interference with daily activities, and ultimately affect health-related quality of life (HRQoL). Objective: To assess patient-reported HRQoL changes over time during long-term treatment with eltrombopag in patients with cITP using the final EXTEND data. Methods: Four standard validated HRQoL instruments for chronic disease were used in this study: SF-36v2 including the Physical Component Summary (PCS) and Mental Component Summary (MCS) to measure general physical and mental health status; Motivation and Energy Inventory Short Form (MEI-SF) to measure motivation and energy; Fatigue Subscale of FACIT (FACIT-F) to measure symptoms of fatigue; and FACT-Thrombocytopenia Subscale Six-Item Extract (FACT-Th6) to measure concerns related to bleeding and bruising and their impact on usual activities. The instruments were used at baseline (BL) and at a frequency of every 3 months until last on-treatment assessment. Patients were blinded to their current platelet count results before completing the questionnaires. Generalized estimating equations were used to estimate mean changes in HRQoL from BL to different time periods for each instrument, accounting for within-patient correlation. The models adjusted for time period from BL, demographic characteristics, BL clinical characteristics (BMI, BL use of cITP medication, prior splenectomy, prior eltrombopag use, and BL platelet count), and time-varying covariates for rescue therapy use (defined as the composite of new cITP medication, increased dose of cITP medication from BL, platelet transfusion, and splenectomy). Adjusted mean best changes in HRQoL from BL were also estimated using a similar method. Proportions of responders based on minimally important difference (MID) from BL were identified for each of the instruments. Response was defined as a change from BL score of at least one-half the standard deviation (SD) of the normalized scores (5 points) for SF-36v2 PCS and SF-36v2 MCS, at least one-half the SD of BL scores observed across all patients for MEI-SF and FACT-Th6, and at least 3 or 5 points for FACIT-F. Proportions of patients achieving any improvement and time to best improvement from BL were also reported. Results: 302 patients were enrolled in EXTEND. By instrument, 289 to 293 patients had a BL and at least one on-treatment HRQoL assessment for analysis. Median treatment duration was 2.4 years. All HRQoL instruments had positive mean changes from BL over time; noticeably improvements from BL persisted through 5 years of treatment for FACIT-F and FACT-Th6 (nearly all p Conclusion: About 80% of patients with cITP treated with eltrombopag experienced an improvement from BL in HRQoL, often within a year of BL. About half of patients achieved a clinically meaningful response from BL. This study found positive and meaningful mean best changes from BL in all HRQoL scores, including those measurements more closely related to clinical outcomes such as fatigue, bleeding, and bruising as well as more general measures such as motivation, energy, physical and mental health status. Improvements from BL persisted over time in particular for fatigue, bleeding, bruising, and physical health status. Disclosures Saleh:GSK: Consultancy, Research Funding, Speakers Bureau. Burgess:Novartis: Employment. Portella:Novartis: Employment. Roy:Novartis: Employment. Barghout:Novartis: Consultancy. Ivanova:Novartis: Research Funding; GSK: Research Funding; Teva: Research Funding; Lilly: Research Funding. Bussel:GSK: Consultancy, Honoraria, Membership on an entity9s Board of Directors or advisory committees, Research Funding; Immunomedics: Research Funding; Rigel Pharmaceuticals: Membership on an entity9s Board of Directors or advisory committees, Research Funding; UpToDate: Patents & Royalties; Boehringer Ingelheim: Research Funding; Shionogi: Membership on an entity9s Board of Directors or advisory committees; Genzyme: Research Funding; Protalex: Membership on an entity9s Board of Directors or advisory committees, Research Funding; Cangene: Research Funding; Ligand: Membership on an entity9s Board of Directors or advisory committees, Research Funding; Prophylix Pharma: Membership on an entity9s Board of Directors or advisory committees, Research Funding; Sysmex: Research Funding; BiologicTx: Research Funding; Eisai: Membership on an entity9s Board of Directors or advisory committees, Research Funding; Physicians Education Resource: Speakers Bureau; Momenta Pharmaceuticals: Membership on an entity9s Board of Directors or advisory committees; Symphogen: Membership on an entity9s Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity9s Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity9s Board of Directors or advisory committees, Research Funding.

Improvements in Patient Health-Related Quality of Life (HRQoL) with Clinical Efficacy in Patients Treated with Eltrombopag: Final Results from the Long-Term, Open-Label Extend Study

Background:EXTEND (June 2006 to July 2015) was an open-label, dose-adjustment extension study to evaluate the safety and efficacy of eltrombopag for the treatment of patients with chronic immune thrombocytopenia purpura (cITP) who had previously been enrolled in a pivotal eltrombopag trial. CITP may lead to fatigue and interference with daily activities, and affect patient functioning and experience i.e., health-related quality of life (HRQoL).Objective:To investigate the association between platelet response and HRQoL reported by patients in the EXTEND study, employing widely used and well-validated measures.Methods:Four standard HRQoL instruments were used in this study: SF-36v2 including Physical Component Summary (PCS) and Mental Component Summary (MCS) to measure general physical and mental health status; Motivation and Energy Inventory Short Form (MEI-SF) to measure motivation and energy; Fatigue Subscale of FACIT (FACIT-F) to measure symptoms of fatigue; and FACT-Thrombocytopenia Subscale Six-Item Extract (FACT-Th6) to measure concerns related to bleeding and bruising and their impact on usual activities. The four instruments were used at baseline (BL) and at a frequency of every 3 months until last on-treatment assessment. Patients were blinded to their current platelet count results before completing the questionnaires. HRQoL scores and mean platelet count based on clinical assessments were calculated during time periods post-baseline (BL) to <3 months, ≥3 to <6 months, and at 6-month periods thereafter. Three definitions of response in the absence of rescue therapy (composite of new cITP medication, increased dose of cITP medication from BL, platelet transfusion, and splenectomy) were considered: 1) platelet count ≥30 Gi/L (109/Liter); 2) platelet count ≥50 Gi/L; and 3) platelet count ≥50 Gi/L and > 2 times BL. Generalized estimating equations were used to assess the association between HRQoL over time and clinical response, accounting for within-patient correlation. Covariates included demographic characteristics and BL clinical characteristics (BMI, BL use of cITP medication, prior splenectomy, prior eltrombopag use, and BL platelet count).Results:302 patients were enrolled in EXTEND. Between 273 and 292 (depending on instrument) had a BL, at least one on-treatment HRQoL assessment, and platelet count information. Baseline platelet count was <30 Gi/L for 69.9% of patients. Median treatment duration was 2.4 years. During treatment, 86.8% of the patients achieved platelet response of platelet count ≥30 Gi/L, 79.8% achieved ≥50 Gi/L, and 75.2% achieved ≥50 Gi/L and 2x BL at least once during the study. All HRQoL instruments had a positive best mean change from BL greater than a minimally important difference of at least half a standard deviation from BL score or an established threshold. All four HRQoL instruments had positive association with the three platelet response definitions. The adjusted mean score increase (signifying improvement) associated with platelet response compared to no response was 0.9-1.3 for SF-36v2 PCS, 0.8-1.3 for SF-36v2 MCS, 1.3-1.9 for MEI-SF, 1.6-2.0 for FACIT-F, and 1.8-2.3 for FACT-Th6 (most p <0.05; Table 1).Conclusion:These data show positive associations between platelet response and HRQoL measurements, especially with SF-36v2 PCS, FACIT-F, and FACT-Th6. Benefits from eltrombopag therapy in increasing platelet counts may carry forward into alleviating fatigue, concerns about bleeding and bruising, as well as enhancing motivation, energy, general physical and mental health status. [Display omitted] DisclosuresSaleh:GSK: Consultancy, Research Funding, Speakers Bureau. Bussel:Boehringer Ingelheim: Research Funding; Protalex: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Physicians Education Resource: Speakers Bureau; Rigel Pharmaceuticals: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Eisai: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Prophylix Pharma: Membership on an entity’s Board of Directors or advisory committees, Research Funding; GSK: Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding; Novartis: Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding; UpToDate: Patents & Royalties; Momenta Pharmaceuticals: Membership on an entity’s Board of Directors or advisory committees; Symphogen: Membership on an entity’s Board of Directors or advisory committees; Shionogi: Membership on an entity’s Board of Directors or advisory committees; Sysmex: Research Funding; Immunomedics: Research Funding; Genzyme: Research Funding; Cangene: Research Funding; BiologicTx: Research Funding; Ligand: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Amgen: Consultancy, Honoraria, Membership on an entity’s Board of Directors or advisory committees, Research Funding. Burgess:Novartis: Employment. El-Ali:Novartis: Employment. Roy:Novartis: Employment. Barghout:Novartis: Consultancy. Duh:Novartis: Research Funding; Abbvie: Consultancy; Allergan: Consultancy; GSK: Research Funding; Bayer: Research Funding; Janssen: Research Funding; Eisai: Research Funding; Pfizer: Research Funding; Medtronic: Research Funding; Takeda: Research Funding; Novo Nordisk: Research Funding; Sanofi: Research Funding; Ariad: Research Funding.

The Burden of Poor Mental Well-being Among Patients With Type 2 Diabetes Mellitus: Examining Health Care Resource Use and Work Productivity Loss.

Objective:The aim of this study was to evaluate the association of mental well-being with outcomes among patients with type 2 diabetes mellitus (T2DM).Methods:Seven thousand eight hundred fifty-two adults with T2DM were identified from a national, Internet-based study. Mental well-being [SF-36v2 mental component summary (MCS)] was categorized as good (MCS ≥ 50), poor (40 ≤ MCS < 50), and very poor (MCS < 40). Outcomes included past 6 months of health care resource use and lost productivity (Work Productivity and Activity Impairment questionnaire).Results:Respondents with very poor/poor versus good mental well-being were more likely to visit the emergency room (27%/18% vs 11%, P < 0.001) or be hospitalized (19%/14% vs 9%, P < 0.001). Among labor force participants, those with very poor/poor versus good mental well-being experienced greater overall work impairment (43.7/26.0 vs 10.7, P < 0.001).Conclusions:Greater resource use and work productivity impairment associated with poorer mental well-being among patients with T2DM has cost implications.

Match injuries in amateur Rugby Union: a prospective cohort study - FICS Biennial Symposium Second Prize Research Award.

BackgroundThe majority of Rugby Union (rugby) players participate at the amateur level. Knowledge of player characteristics and injury risks is predominantly ascertained from studies on professional or junior athletes in rugby. The objectives of the current study are to: (1) describe the health-related quality of life (HRQoL) and physical characteristics of a cohort of amateur rugby players; (2) describe the incidence, severity and mechanism of match injuries in amateur rugby, and; (3) explore factors associated with rates of match injury in this population.MethodsParticipants (n = 125) from one amateur men’s rugby club were followed in a one-season (2012) prospective cohort study. Match injury and match time exposure data were collected. A participant match exposure log was maintained. Baseline variables collected include: participant’s age, playing experience, position of play, the SF-36v2 health survey, height and weight. Injury incidence rates (IIRs) per 1000 match-hours exposure were calculated. Injury sub-groups were compared by calculating rate ratios of two IIRs. Poisson mixed-effects generalised linear modelling was used to explore relationships between IIRs and baseline predictors.ResultsA total of 129 injuries occurred during a combined period of 2465 match-hours of exposure. The overall IIR was 52.3 (43.7–62.2) /1000 match-hours exposure. Moderate-severe injuries (>1 week time-loss from play) comprised 36 % of all injuries. Tackling was the most common mechanism of injury, the head/face was the most common body region of injury and sprain/ligament injuries were the most common injury type. Fewer years of rugby participation, lower BMI and lower SF-36v2 mental component summary score were associated with higher IIR in amateur rugby. Age, player position i.e., backs versus forwards and SF-36v2 physical component summary score were not associated with injury incidence.ConclusionAmateur rugby players report similar HRQoL as the general population. We found amateur players had a higher rate of injury and lower injury severity than previous amateur studies, but location, type, and mechanism were similar. In this study pre-season HRQoL and BMI were weakly associated with higher injury rate when controlling for other factors; a finding that should be interpreted with caution and clarified with future research.Electronic supplementary materialThe online version of this article (doi:10.1186/s12998-016-0098-7) contains supplementary material, which is available to authorized users.

Psychometric validation of the Brief Pain Inventory-Short Form in patients with systemic lupus erythematosus in the United States.

This study evaluated the Brief Pain Inventory-Short Form (BPI-SF) in patients with moderate-to-severe systemic lupus erythematosus (SLE). Patients ≥18 years old who self-reported a physician diagnosis of SLE (confirmed by medical record review) and active SLE (Systemic Lupus Activity Questionnaire (SLAQ) score of ≥11) were included. The BPI-SF and Short Form Health Survey version 2 (SF-36v2) were administered electronically at baseline, week 2 and week 12. Psychometric properties of the BPI-SF were evaluated. Cronbach alphas were >0.9 for all BPI-SF items, domains and total score. Test-retest reliability correlations for responses between baseline and week 2 of the BPI-SF had intraclass correlation coefficients (ICCs) ≥0.5. The BPI-SF domains and total score were moderately positively correlated to the SLAQ score (r ≥ 0.4), but negatively correlated to the SF-36v2 bodily pain domain (r ≤ -0.6). The BPI-SF domains and total score were moderately negatively correlated to the SF-36v2 physical functioning domain and physical component summary (r ≤ -0.4), with low correlations between the BPI-SF severity domain and SF-36v2 mental component summary (r = -0.16). Assessment of pain, as measured by the BPI-SF, demonstrated validity and reliability in a sample of patients with moderate-to-severe SLE.

PDB82 - Utilizing the sf-36v2 mental Component Summary Score to describe Mental well-Being Experienced By Patients with Type 2 Diabetes

PDB82 - Utilizing the sf-36v2 mental Component Summary Score to describe Mental well-Being Experienced By Patients with Type 2 Diabetes

The relationship between preoperative general mental health and postoperative quality of life in minimally invasive lumbar spine surgery.

In assessing poor lumbar surgery outcomes, researchers continue to investigate psychosocial predictors of patient postoperative quality of life. This is the first study of its kind to investigate this relationship in an exclusively minimally invasive patient sample. To determine the association between preoperative mental health and postoperative patient-centered outcomes in patients undergoing minimally invasive lumbar surgery. In 83 adults undergoing single-level minimally invasive lumbar spine surgery, Pearson correlation and partial correlation analyses were conducted between all demographic and clinical baseline variables and Oswestry Disability Index (ODI), Visual Analogue Scale (VAS), and 36-item Short-Form Health Survey Version 2.0 (SF-36v2) scores at 6 to 12 months postoperatively. SF-36v2 mental component summary scores (MCS) were used to assess pre- and postoperative general mental health. Post hoc analysis consisted of Pearson correlations between baseline SF-36v2, ODI, and VAS scores, and an identical set of correlations at outcomes. Preoperative MCS showed no significant association with outcomes VAS, ODI, or physical component summary scores. Baseline disability correlated significantly and more strongly with baseline MCS (P < .001, r = -0.40) than baseline pain levels (VAS back not significant, VAS leg P = .015, r = 0.27). Outcomes disability correlated significantly and more strongly with outcome back and leg pain levels (P < .001, r = 0.60 and 0.66) than outcome MCS (P = .031, r = -0.24). In a patient sample with mental health scores comparable to the population mean, there is no relationship between preoperative general mental health and postoperative patient-centered outcomes. Surgeons should consider the dynamic relationships between patient disability, mental health, and pain levels in assessing quality of life at different time points.

The impact of lower urinary tract symptoms on health-related quality of life among patients with multiple sclerosis.

Lower urinary tract symptoms are commonly experienced among patients with multiple sclerosis (MS), however, their impact on health-related quality of life (HRQOL) has not been well characterized. Herein the incremental impact of lower urinary tract symptoms on HRQOL among patients with MS has been evaluated. A cross-sectional online survey was administered to US residents with a self-reported MS diagnosis. Data pertaining to demographics, disease history, urinary symptoms, and HRQOL, including the Short Form 36, version 2 (SF-36v2), were collected. Patients were stratified into four urinary symptom groups: no/minimal urinary symptoms, urinary urgency (UU), urinary urgency incontinence (UUI), and other lower urinary tract symptoms. Multiple linear regression models evaluated the impact of these symptoms. Out of the 1,052 respondents, mean age was 47.8 ± 10.6 years; mean time since MS diagnosis was 8.5 ± 7.8 years. UUI and UU subgroups showed the greatest adjusted HRQOL decrement compared with the no/minimal urinary symptoms group, scoring 2.8 (SE ± 0.7, UUI) and 3.5 (SE ± 0.8, UU) points lower on SF-36v2 Physical Component Summary, respectively, and 3.7 (SE ± 1.0, UUI) and 5.0 (SE ± 1.2, UU) points lower on SF-36v2 Mental Component Summary (P < 0.001 for all), respectively. Both UU and UUI symptoms contribute to a decrement in HRQOL among patients with MS.

Su1030 Genetic Variation in Vitamin D Pathway DHCR7 Gene Predicts Poor Response to Pegylated Interferon-Alfa Based Therapy in Asian Chronic Hepatitis C Genotype 1-Infected Patients

were descriptively evaluated for observed self-reportedQOL (SF-36v2) andwork productivity and activity impairment (WPAI) assessments. Assessments were scored such that lower SF36v2 Mental Component Summary (MCS) and Physical Component Summary (PCS) scores corresponded to lower QOL while higher WPAI scores represented higher levels of impairment and work time missed. Results: Among the 71,157 NHWS total respondents, 0.9% reported an HCV diagnosis, 1.3% CHF, 2.8% MI, 5.0% COPD, 10.9% Diabetes, 14.9% Depression, and 17.3%OA. Among these 7 cohorts, the HCV cohort was the second youngest with a mean age of 54 years and had the second highest proportion of male respondents (69.8%). The HCV cohort was observed to have the second lowest average MCS scores (44.6) among the seven cohorts while having mean PCS scores (43.7) that were numerically third highest (Table 1.). Full-time employment was reported by 25.0% of the HCV group, 17.2% COPD, 28.9% Depression, 14.7% MI, 20.2% OA, 11.4% HF, and 24.4% Diabetes. Numerically, the HCV cohort had the second highest reported overall work impairment scores (29.5%) among the seven conditions and was ranked between cohorts for mean total activity impairment scores (39.8%). Conclusions: Results provide further insight into QOL and productivity as reported by a population of US survey respondents with HCV. Although one-fourth of survey respondents with HCV reported full-time employment, these same individuals reported productivity losses in the forms of absenteeism and presenteeism. Further evaluation of the impact of comorbidity burden and HCV treatment on these patient outcomes is warranted. Table 1. Cohort Mean Scores

Perioperative risks associated with the operative treatment of clavicle fractures

BackgroundClavicle fractures are a common injury among young adults who were historically treated non-operatively with satisfactory outcomes. However, more recent studies have shown a higher nonunion rate for displaced clavicle fractures treated conservatively. The purpose of this study is to investigate the midterm complications, clinical outcomes and overall patient satisfaction after osteosynthesis of midshaft clavicular fractures. Patients and methodsA total of 37 patients treated for a clavicle fracture from January 2007 to December 2008 with at least 12 months’ follow-up were identified from a billing code search. At the latest follow-up appointment, the patients completed the Constant Shoulder, the Disabilities of the Arm, Shoulder and Hand scale (DASH) and the Medical Outcomes Study 36-Item Short-Form Health Survey version 2.0 (SF36v2) functional outcome surveys as well as a custom questionnaire to assess hand dominance, employment status, the amount of time taken before returning to work, the presence of numbness around the incision site (a surrogate marker of a supraclavicular nerve palsy), whether the patient desired the plate removed and/or if it was worth another surgery. ResultsWith regard to the functional outcome surveys, the average DASH score was 11.8±16.4, the Constant score was 93.3±7.2, the SF36v2 physical component summary (PCS) was 50.7±10.1 and the SF36v2 mental component summary (MCS) 50.6±11.2. From the custom questionnaire, 27 patients (73%) found their cosmetic appearance acceptable while the remaining 10 patients (27%) were bothered by the appearance of the plate. The average time to return to work was 82.1±77.4 days. There were no infections, refractures or nonunions of the clavicle. ConclusionAs the relative indications for open reduction and internal fixation of clavicle fractures become more popular, such as cosmetic concerns or faster recovery, we wish to demonstrate that the procedure is not without risks, including implant discomfort requiring a subsequent operation for removal, numbness around the incision site and infection. Despite these risks, patients tend to be satisfied with the procedure and are able to function at levels equal to that of the general population. The purpose of this study is not to recommend for or against operative treatment of clavicle fractures but merely to demonstrate risks associated with the procedure.