Mental Domain Scores Research Articles

5184 Tirzepatide Improved Mental and Psychosocial Health-Related Quality of Life in Adults with Obesity or Overweight: Results from the SURMOUNT-4 phase 3 Trial

Abstract Disclosure: T.M. Gibble: Employee; Self; Employment and stockholder, Eli Lilly and Company. D. Cao: Employee; Self; Employment and stockholder, Eli Lilly and Company. M. Murphy: Employee; Self; Employment and stockholder, Eli Lilly and Company. I. Jouravskaya: Employee; Self; Employment and stockholder, Eli Lilly and Company. B. Liao: Employee; Self; Employment and stockholder, Eli Lilly and Company. Background: Tirzepatide is a once weekly glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist approved in the U.S. for treatment of type 2 diabetes (T2D) and obesity. In the phase 3 SURMOUNT-4 trial with randomized withdrawal of tirzepatide maximum tolerated dose (MTD) after the first 36 weeks, continuing tirzepatide for a total of 88 weeks led to a mean weight reduction of 25.3% from baseline compared to 9.9% for those who switched to placebo (PBO).[1] This analysis evaluated the effect of tirzepatide versus PBO on mental and psychosocial health-related quality of life (HRQoL) outcomes using the SURMOUNT-4 trial data. Methods: Adults (n=783) with body mass index ≥30 or ≥27 kg/m2 and ≥1 obesity-related complication (excluding T2D) were enrolled in an open-label lead-in period to receive tirzepatide once weekly subcutaneously for 36 weeks, escalated to MTD (10 mg or 15 mg). At week (W) 36, 670 participants were randomized 1:1 to continue tirzepatide MTD (n=335) or were switched to PBO (n=335) for 52 weeks. HRQoL was evaluated from W0 to W88 using the Short Form-36 Version 2 Health Survey (SF-36 v2) acute form and Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT), where the last observation before discontinuation was carried forward. Higher scores of SF-36v2 (Mental Component Summary [MCS], role-emotional, and mental health), and IWQOL-Lite-CT (psychosocial composite) reflected better levels of mental function. Least square mean (LSM) changes and estimated treatment differences (ETD) between tirzepatide and PBO were calculated using an analysis of covariance model. Results: LSM changes in mental domain scores for SF-36 v2 and IWQOL-Lite-CT were comparable during lead-in (W0 to W36) between participants randomized to tirzepatide and PBO. Significant improvements were observed from W36 to W88 in SF-36v2 mental domain scores for tirzepatide versus PBO, with LSM scores ( ETD) as follows: MCS, 54.6, 52.9 (1.7, p=0.001); role-emotional, 53.0, 51.1 (1.9, p=0.001), and mental health, 55.4, 52.9 (2.4, p<0.001), respectively. LSM change from W36 to W88 in SF-36 v2 mental domain scores for tirzepatide and PBO were: MCS, 0.1 and -1.6; role-emotional, 0.6 and -1.2, and mental health, 0.3 and -2.1, respectively. Tirzepatide showed significant improvements in IWQOL-Lite-CT psychosocial scores versus PBO from W36 to W88, with LSM scores ( ETD) of 87.7, 75.6 (12.1; p<0.001), respectively. LSM change from W36 to W88 in IWQOL-Lite-CT psychosocial scores for tirzepatide and PBO were 5.1 and -7.0, respectively. Conclusion: In the SURMOUNT-4 trial, adults with overweight or obesity continuing on tirzepatide MTD showed significant and sustained improvements in mental and psychosocial HRQoL compared to those switching to placebo. [1] Sattar N. 59th Annual Meeting European Association for the Study of Diabetes; Oct 2023; Hamburg, Germany. Presentation: 6/1/2024

9229 Tirzepatide Improved Mental and Psychosocial Health-Related Quality of Life in Adults with Obesity or Overweight: Results from the SURMOUNT-4 phase 3 Trial

Abstract Disclosure: T.M. Gibble: Employee; Self; Employment and stockholder, Eli Lilly and Company. D. Cao: Employee; Self; Employment and stockholder, Eli Lilly and Company. M. Murphy: Employee; Self; Employment and stockholder, Eli Lilly and Company. I. Jouravskaya: Employee; Self; Employment and stockholder, Eli Lilly and Company. B. Liao: Employee; Self; Employment and stockholder, Eli Lilly and Company. Background: Tirzepatide is a once weekly glucose-dependent insulinotropic polypeptide and glucagon-like peptide-1 receptor agonist approved in the U.S. for treatment of type 2 diabetes (T2D) and obesity. In the phase 3 SURMOUNT-4 trial with randomized withdrawal of tirzepatide maximum tolerated dose (MTD) after the first 36 weeks, continuing tirzepatide for a total of 88 weeks led to a mean weight reduction of 25.3% from baseline compared to 9.9% for those who switched to placebo (PBO).[1] This analysis evaluated the effect of tirzepatide versus PBO on mental and psychosocial health-related quality of life (HRQoL) outcomes using the SURMOUNT-4 trial data. Methods: Adults (n=783) with body mass index ≥30 or ≥27 kg/m2 and ≥1 obesity-related complication (excluding T2D) were enrolled in an open-label lead-in period to receive tirzepatide once weekly subcutaneously for 36 weeks, escalated to MTD (10 mg or 15 mg). At week (W) 36, 670 participants were randomized 1:1 to continue tirzepatide MTD (n=335) or were switched to PBO (n=335) for 52 weeks. HRQoL was evaluated from W0 to W88 using the Short Form-36 Version 2 Health Survey (SF-36 v2) acute form and Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT), where the last observation before discontinuation was carried forward. Higher scores of SF-36v2 (Mental Component Summary [MCS], role-emotional, and mental health), and IWQOL-Lite-CT (psychosocial composite) reflected better levels of mental function. Least square mean (LSM) changes and estimated treatment differences (ETD) between tirzepatide and PBO were calculated using an analysis of covariance model. Results: LSM changes in mental domain scores for SF-36 v2 and IWQOL-Lite-CT were comparable during lead-in (W0 to W36) between participants randomized to tirzepatide and PBO. Significant improvements were observed from W36 to W88 in SF-36v2 mental domain scores for tirzepatide versus PBO, with LSM scores ( ETD) as follows: MCS, 54.6, 52.9 (1.7, p=0.001); role-emotional, 53.0, 51.1 (1.9, p=0.001), and mental health, 55.4, 52.9 (2.4, p<0.001), respectively. LSM change from W36 to W88 in SF-36 v2 mental domain scores for tirzepatide and PBO were: MCS, 0.1 and -1.6; role-emotional, 0.6 and -1.2, and mental health, 0.3 and -2.1, respectively. Tirzepatide showed significant improvements in IWQOL-Lite-CT psychosocial scores versus PBO from W36 to W88, with LSM scores ( ETD) of 87.7, 75.6 (12.1; p<0.001), respectively. LSM change from W36 to W88 in IWQOL-Lite-CT psychosocial scores for tirzepatide and PBO were 5.1 and -7.0, respectively. Conclusion: In the SURMOUNT-4 trial, adults with overweight or obesity continuing on tirzepatide MTD showed significant and sustained improvements in mental and psychosocial HRQoL compared to those switching to placebo. [1]Sattar N. 59th Annual Meeting European Association for the Study of Diabetes; Oct 2023; Hamburg, Germany. Presentation: 6/1/2024

An Analysis of Welfare Standards Within Tiger (Panthera tigris) Facilities in Thailand.

In Thailand, tigers are more numerous in captivity than they are in the wild, with 51 facilities housing approximately 1962 tigers. As charismatic fauna, tigers are popular with tourists, and the majority of facilities offer a variety of entertainment activities with controversial reports towards the animals' welfare. The aim of this research was to investigate tiger welfare in Thai zoos to identify specific welfare issues. We assessed 34 tourism facilities holding tigers in Thailand in 2019 using a 25-point welfare assessment that utilizes the Five Domain model (incorporating all five domains: nutrition, physical environment, health, behavioural interactions and mental state). The mental domain score was derived from the scores of the other four domains. Additional data were collected from each facility, including the number of tigers, any colour variants, types of human interaction and admission cost. Welfare scores for each domain were calculated by totalling the scores per domain and dividing by the number of points allocated to that domain. A multiple regression was used to identify any significant predictors of mental domain score. The results revealed that the provision of a suitable physical environment scored the lowest, while nutrition scored the highest though this was still a low score overall. The multiple regression showed that 45.4% of the variance for the mental domain score was significantly affected by the number of colour variants housed and the types of human interaction available with facilities, with more of both these factors contributing to a more negative score. Our results demonstrate the need for urgent, comprehensive infrastructural, species-appropriate environment and design and animal management improvements to increase animal welfare. Informed institutional change toward the breeding and use of tigers for public interactions is also required. This is the first assessment completed of captive tiger welfare of tiger facilities in Thailand and shows that the welfare concerns encountered are within a high proportion (67%) of Thailand's facilities. This supports the need for the creation and enforcement of effective and clear captive wildlife operational standards to provide a sustained solution for captive tiger welfare and can provide a considered approach to ex-situ tiger management that, in conjunction with in-situ efforts, can improve much needed conservation efforts of this species.

365 Outcomes of Circumferential Minimally-Invasive Technique Versus Open Technique in Adult Spinal Deformity Surgery Patients Over 80 Years of Age: A Propensity-Matched Analysis

INTRODUCTION: Circumferential minimally-invasive surgery (cMIS) techniques in ASD surgery may provide benefit in reducing physiologic burden, but the utility of such surgeries in patients greater than 80 years of age has not been assessed. METHODS: Operative ASD patients 18yrs with complete pre-(BL) and 2-year(2Y) data were assessed. Patients aged =80years were isolated and compared by surgical technique: Open vs cMIS. BL and peri/post-operative factors were assessed using ANOVA and Bonferroni-adjusted ANCOVA while controlling for BL CCI and posterior levels fused. Propensity score matching (PSM) was used to align cMIS vs Open groups by BL CCI, C7-S1 SVA, PI-LL, and C7PL. RESULTS: 174 ASD patients were included (62.85 ± 13.93 years, 75.7% female), split evenly between cMIS and Open. 19.5% (n = 34) were octogenarians; 29.4% operated via cMIS vs 70.6% Open. At baseline, patients were comparable in gender, BMI, and history of spine surgery (all p > .05). At BL, frailty scores were comparable (both p > .05). Post-operatively, Open patients reported higher SRS-22 Appearance and Mental domain scores (both p < .005), and were more likely to reach MCID in both domains by 2Y (p = .025, .024, respectively). In terms of post-operative complications, cMIS patients were more likely to require reoperation for radiographic sagittal imbalance by 2Y when controlling for CCI and levels fused (20.0% vs 8.3%, p < .001). By 2Y, there were no recorded deaths in the cMIS nor Open octogenarians. CONCLUSIONS: Our comparison of octogenarian adult spinal deformity patients undergoing circumferential minimally-invasive versus open surgery demonstrates that while cMIS patients benefit from decreased blood loss, operative time, and SICU and hospital length of stay, both Open and cMIS patients benefit from similar improvement in patient-reported outcomes. Likewise, Open technique, though more invasive, may also reduce the risk for reoperation due to radiographic instability by 2Y post-operatively.

Effects of Radio-Taiso on Health-related Quality of Life in Older Adults With Frailty: a Randomized Controlled Trial.

Radio-Taiso, a long-standing exercise program in Japan, could be a sustainable public health strategy for maintaining quality of life (QoL) in older adults with frailty. This study aimed to investigate whether Radio-Taiso provided greater benefits for health-related quality of life (HRQoL) and to identify the mechanisms underlying the effectiveness in this population. A 12-week randomized controlled trial enrolled 226 older Japanese adults with pre-frailty or frailty, assessed using the modified frailty phenotype. Participants were randomly allocated to the intervention (Radio-Taiso + nutrition program) or control (nutrition program) groups. The Radio-Taiso program comprised five 60-min group sessions and daily practice at the participants' homes. The primary outcome was the change in the mental domain of HRQoL, assessed using the SF-36®. The secondary outcomes included six physical fitness items and exercise self-efficacy. Overall, 104 and 105 participants in the intervention and control groups, respectively, were analyzed based on the intention-to-treat principle. The median daily practice rate of Radio-Taiso was 94.1% (interquartile range, 73.2-98.8%). Although general linear models adjusted for baseline values and allocation stratification factors showed that the intervention group obtained greater benefits (adjusted mean differences) in the up-and-go (0.3; 95% confidence interval [CI], 0.1 to 0.6 s), 2-min step-in-place (-3.2; 95% CI, -6.2 to -0.2 steps) tests, and exercise self-efficacy scale (-1.4; 95% CI, -2.6 to -0.1 points) than the control group, there were no group differences in changes in the mental domain score of HRQoL. Radio-Taiso provided greater benefits for agility/dynamic balance, aerobic endurance, and exercise self-efficacy in older adults with frailty; however, these changes do not improve HRQoL.

Sexual function in Chinese women with different clinical phenotypes of polycystic ovary syndrome

Objective: To investigate sexual function stratified according to four clinical phenotypes of polycystic ovary syndrome (PCOS) and its association with clinical and quality of life parameters, and to compare these with healthy controls in Chinese women with PCOS. Methods: A cross-sectional study was designed in 1000 PCOS women and 500 control women aged 18–45 years. PCOS women were grouped into four clinical phenotypes according to the Rotterdam Criteria. FSFI (Female Sexual Function Index), SF-12 (the 12-item short form health survey) and clinical and hormonal characteristics likely to affect sexual function were determined. Results: 809 PCOS women and 385 control women with complete parameters were evaluated after screening. Phenotype A had a lower total FSFI mean score (23.14 ± 3.22) compared with phenotype D and control group (p < 0.05). The control group had the highest total FSFI mean score (24.98 ± 3.78). For the percentage at risk of sexual dysfunction, phenotype A (87.5%) and phenotype B (82.46%) had a higher risk of female sexual dysfunction (FSD) than that in phenotype C (75.34%), phenotype D (70.56%) and control group (61.30%) (p < 0.05). SF-12 mental domain scores were significantly lower in phenotypes A and B compared with phenotypes C and control group (p < 0.05). Infertility treatment, bioavailable testosterone, psychological factors, age and waist circumference presented negative correlation with female sexual function. Conclusions: The risk of FSD in PCOS women seemed to be associated with PCOS clinical phenotypes. The classical PCOS phenotype with oligo-ovulation and hyperandrogenism had a higher risk of sexual dysfunction.

148. Impact of self-reported loss of balance and gait disturbance on adult spinal deformity surgery outcomes

148. Impact of self-reported loss of balance and gait disturbance on adult spinal deformity surgery outcomes

Postoperative exercise training improves the quality of life in patients receiving pulmonary resection: A systematic review and meta-analysis based on randomized controlled trials

PurposeTo evaluate whether postoperative exercise training is effective in improving clinical outcomes such as the quality of life (QoL), exercise capacity and respiratory function of patients receiving pulmonary resection. Data sourcesThe PubMed, EMBASE, Web of Science and PEDro electronic databases were comprehensively searched to identify eligible randomized controlled trials (RCTs). MethodsThe PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines were followed. The primary outcome was postoperative QoL and secondary outcomes were exercise capacity and respiratory function. ResultsA total of eight studies involving 691 participants were enrolled in this systematic review and meta-analysis. For the postoperative QoL measured by 36-Item Short Form Health Survey (SF-36), the pooled results demonstrated that postoperative exercise training could significantly improve the SF-36 physical domain score [weighted mean difference (WMD) = 5.87, 95% confidence interval (CI): 3.96 to 7.78, P＜0.001] and SF-36 mental domain score (WMD = 8.15, 95% CI: 0.13 to 16.16, P = 0.05). The results of further analysis for the eight dimensions of SF-36 were similar to the overall results. However, for secondary outcomes, no significant effects of postoperative exercise training on exercise capacity and respiratory function were observed. ConclusionPostoperative exercise training could significantly improve the QoL of patients undergoing lung surgery. However, more RCTs with large samples are still needed to verify the effects of postoperative exercise rehabilitation on clinical outcomes of patients who receive pulmonary resection.

Health-Related Quality of Life in Patients with Haemophilia and Its Association with Depressive Symptoms: A Study in Croatia and Slovenia.

There are only a few studies in patients with haemophilia (PWH) that examined both quality of life and depressive symptoms, with only few studies examining their association. Aim of this study was to examine the association between depressive symptoms and health-related quality of life (HRQoL) in PWH from Croatia and Slovenia. A total of 112 adult PWH on prophylactic (73%) or on-demand (27%) treatment were included in the study (median age 46 years, range 18-73 years). Depressive symptoms were assessed with BDI-II, HRQoL with SF-36v2, demographic and socioeconomic data were collected using a questionnaire, and clinical data were obtained from medical records. All HRQoL scores were significantly negatively correlated with BDI-II in the -0.42 to -0.70 range (all p<0.05). Socio-demographic and clinical variables explained 28-51% of HRQoL variance scores. Depressive symptoms explained additional variance for six HRQoL domain scores, with incremental variance being larger for mental domain scores (ranging between 10-27%), and for Mental Component Summary score (26%). This study's findings support that having depressive symptoms is associated with HRQoL of PWH, more so in the mental health than in the physical health domains.

Factors and health-related quality of life associated with participation in a post-ICU follow-up. A register study.

Follow-up for heterogeneous intensive care patients presents challenges for rehabilitation interventions and outcome measurements. The aim was to describe and explore characteristics and determinants for visiting/not visiting a nurse-led clinic (NLC) at different time-points, and to describe physical and mental health (HRQoL) over time. Patients with a length of stay (LOS) of ≥72hours, discharged from a general intensive care unit 2004-2014, who participated in a 6-month follow-up programme offering visits to NLC at 2 and 6months were included. The register study includes information regarding patients' participation in NLC, clinical and demographic data from the Patient Administrative System within Intensive care, and data on 2-, 6- and 12-month HRQoL by using SF-36 from the Swedish Intensive Care Registry. Of 656 patients, 57% visited the NLC on some occasion. These patients were younger (P=.000), had lower Simplified Acute Physiology scores (P=.001) and higher SF-36 physical health domain scores at 2months (P<.05) compared to those not visiting at all. Visitors at 2months only were younger, had shorter LOS and higher physical and mental domain scores than patients visiting at 6months only. Patients visiting the NLC scored significantly higher in all domains from 2 to 12months, whereas non-visiting-patients' did this in four out of eight domains during the same time frame. Individual patient's characteristics and current health conditions seem to influence visits to NLC or not. The findings may contribute to the development of existing routines to match the diversity of patients' needs and life situations.

Quality of Life and Mental Satisfaction Improve Slowly in Preemptive Kidney Transplantation Compared With Nonpreemptive Kidney Transplantation

Background and aimsPreemptive kidney transplantation (PEKT) is recognized as the best therapy to avoid dialysis. However, it is not clear whether PEKT recipients experience an improvement in quality of life (QoL) after kidney transplantation (KT) that exceeds that of non-PEKT recipients, since PEKT recipients have not experienced the heavy burden of dialysis. The aim of this study was to compare the changes in QoL for PEKT and non-PEKT recipients following transplantation. MethodsPatients included in this study underwent living donor KT in our hospital. We excluded patients with incomplete SF-36 scores and with factors that could affect QoL, such as complications or rejection. QoL was assessed by the Short Form 36-Item Health Survey version 2.0 preoperatively and 3 and 12 months postoperatively. ResultsEighty-eight patients underwent living donor KT in our hospital. Twelve PEKT and 20 non-PEKT recipients were enrolled in this retrospective study. In the non-PEKT group, both the physical and mental domain scores dramatically improved from baseline at 3 months, and remained at a similar level at 12 months. In contrast, in the PEKT group, only 1 domain of the physical and mental score improved at 3 months, and the social functioning score gradually improved at 12 months. Although the mental component score showed significant improvement in the non-PEKT group, it did not change in the PEKT group. ConclusionsThe improvement of QoL after transplantation is more evident in the non-PEKT group. PEKT recipients have less mental satisfaction than non-PEKT recipients.

Clinical measurements versus patient-reported outcomes: analysis of the American Shoulder and Elbow Surgeons physician assessment in patients undergoing reverse total shoulder arthroplasty

BackgroundThe American Shoulder and Elbow Surgeons (ASES) score is composed of a patient-reported portion and a physician assessment. Although the patient-reported score is frequently used to assess postoperative outcomes after shoulder arthroplasty, no previous studies have used the physician-assessment component. This study evaluated the relationship of the ASES physician-assessment measurements with patient-reported shoulder and general health outcomes.MethodsA retrospective review of a prospectively collected multicenter database was used to analyze patients who underwent primary reverse total shoulder arthroplasty (RTSA) from 2012 to 2015 with a minimum 2-year follow-up. ASES physician-assessment and patient-reported components and 12-Item Short Form Health Survey (SF-12) general health questionnaires were obtained preoperatively and 2 years postoperatively. The relationship between ASES physician measurements with ASES patient-reported outcome (PRO) scores and SF-12 Physical and Mental domain scores was assessed with Pearson correlation coefficients.ResultsIncluded were 74 patients (32 men; mean age, 69.2 years; body mass index, 29.4 kg/m2). Preoperative physician measurements and PRO scores were not significantly correlated. Postoperatively, only the ASES physician-measured active (R = 0.54, P < .01) and passive forward flexion (R = 0.53, P < .01) demonstrated moderate correlation with ASES patient scores. The remaining clinical measurements had no significant correlations with ASES patient or SF-12 scores. During the 2-year period, only improvements in active forward flexion correlated with improvements in ASES patient scores (R = 0.36, P < .01).ConclusionsLittle correlation exists between clinical measurements from the ASES physician component and PROs, including the ASES patient-reported and SF-12 general health surveys, in RTSA patients. Improvement in active forward flexion is the only clinical measurement correlated with PRO improvement at 2 years.

The impact of transcatheter aortic valve implantation on quality of life: A mixed methods study

ObjectiveTo provide an in-depth understanding of patients' views about the impact of transcatheter aortic valve implantation on self-reported quality of life. BackgroundTranscatheter aortic valve implantation is considered to be the gold standard of care for inoperable patients diagnosed with severe symptomatic aortic stenosis. Mid- to long-term clinical outcomes are favourable and questionnaire data indicates improvements in quality of life but an in-depth understanding of how quality of life is altered by the intervention is missing. MethodsA mixed methods study design with a total of 89 in-depth qualitative interviews conducted with participants (39% male; mean age 81.7 years), 1 and 3 months post TAVI, recruited from a regional centre in England. Data were triangulated with questionnaire data (SF-36 and EQ5D-VAS) collected, pre, 1 and 3 months post implantation. ResultsParticipants’ accounts were characterised by four key themes; shortened life, extended life, limited life and changed life. Quality of life was changed through two mechanisms. Most participants reported a reduced symptom burden and all explained that their life expectancy was improved. Questionnaire data supported interview data with gradual improvements in mean EQ-5D scores and SF-36 physical and mental domain scores at 1 and 3 months compared to baseline. ConclusionFindings suggest that TAVI was of variable benefit, producing considerable improvements in either mental or physical health in many participants, while a smaller proportion continued to deteriorate.

Evaluating outcome of prophylaxis in haemophilia: objective and self-reported instruments should be combined.

Routine outcome assessment of prophylaxis should use validated tools, while balancing comprehensiveness and burden. Collecting overlapping information should be avoided. To assess correlations between different outcome assessment tools in haemophilia. From an international cross-sectional study, data on objective outcome (Haemophilia Joint Health Score (HJHS 2.1, range 0-124), radiological Pettersson score) and self-reported joint bleeding, Haemophilia Activities List (HAL, range 100-0), health-related quality of life (SF-36, including five physical and five mental domain scores, range 100-0), and Utility (SF6D and EQ-5D, range 1.0-0) were extracted. Spearman's correlations were calculated: ≥0.8 very strong, 0.60-0.79 strong, 0.40-0.59 moderate. Ninety patients with severe haemophilia, on prophylaxis since median age 3.4 years, were evaluated at median 25.5 years (range 16.0-37.6). Objective outcome was favourable (median HJHS 2.1 6 points, Pettersson score 9 points). Self-reported outcome showed a median of 7 joint bleeds in 5 years, median HAL sum 96 points, high scores for physical domains of SF-36 (median 80-95) and high Utility values (median SF6D 0.87; EQ-5D 0.84). Physical examination (HJHS 2.1) showed strong correlation with radiological scores, moderate correlation with physical domains of the SF-36 and Utility, but no correlation with self-reported bleeding or limitations in activities (HAL). Bleeding was not associated with any other outcome parameter. The HAL was only correlated with the SF36 'Physical functioning' domain. For the evaluation of patients on early prophylaxis, information on bleeding should be complemented by objective joint assessment as well as self-reported limitations in activities and quality of life.

THU0293 Assessment of Cognitive Symptoms in Patients with Primary Sjogren’s Syndrome and SLE: Validation of the Brief Cognitive Symptoms Index

BackgroundPatients with primary Sjogren’s syndrome frequently report cognitive symptoms. Self-report assessment tools can be used to screen patients who might benefit from neuropsychological evaluation, but no tool has been validated...

Does Thoracic Hypokyphosis Matter in Lenke Type 1 Adolescent Idiopathic Scoliosis?

Study DesignWe analyzed a prospective cohort of Lenke 1ABC adolescent idiopathic scoliosis (AIS) patients based on differences in T5–T12 sagittal alignment. ObjectiveOur objective was to determine whether patients with hypokyphotic scoliosis demonstrate unique characteristics in terms of baseline health status and response to surgery. Background SummaryRight thoracic AIS often presents as a hypokyphotic scoliosis, with rotatory deformity resulting in a diminution of the normal thoracic kyphosis. The perceived importance is indicated by the inclusion of a sagittal plane modifier within Lenke’s classification system for AIS and studies examining reduction strategies to restore thoracic kyphosis. MethodsWe grouped patients based on thoracic kyphosis, measured from T5 to T12, as either less than 10° (hypokyphotic) or greater than or equal to 10° (normal/kyphotic). We used Student t test for independent samples to compare continuous variables between the hypokyphotic and normal/kyphotic groups. ResultsThere was a significant difference in age between groups (mean age, 14.9 years in the hypokyphotic group versus 13.4 years in the normal/kyphotic group; p = .007). Differences in baseline health status measures were statistically significant but small. Hypokyphotic patients reported less pain than normal/kyphotic patients, with a mean Scoliosis Research Society (SRS) Pain score of 4.15 versus 4.03 (p = .044), better SRS Mental Domain scores (4.06 vs. 3.92; p = .026), and better SRS Total scores (3.92 vs. 3.83, p = .027). The hypokyphotic group also had better SRS Appearance (3.36 vs. 3.30) and Activity scores (4.20 vs. 4.13), but these differences did not reach statistical significance. ConclusionsThere were no differences in baseline or 2-year postoperative outcome scores in Lenke 1 AIS patients with hypokyphosis compared with patients with normal sagittal alignment. Maintenance of or restoration to normal kyphosis in hypokyphotic patients with Lenke 1 AIS may not improve clinical outcome compared with patients who remain lordotic after surgical correction.

Health‐Related Quality of Life in Different Stages of Renal Failure

Measures of health-related quality of life (HRQoL) have a significant predictive value on patient survival and hospitalizations, especially in patients with chronic kidney disease (CKD). In this review, some of the major studies performed in patients with different stages of renal failure are presented. The most used instrument for measuring HRQoL is the Short form health survey questionnaire (SF-36). Patients with predialysis CKD had higher SF-36 scores than a large cohort of hemodialysis (HD) or peritoneal dialysis (PD) patients, but lower scores than those reported for the adult population. Kidney transplantation offers better HRQoL than dialysis. Hemoglobin level predicted both physical and mental domain scores of the SF-36. HRQoL of HD and PD patients were compared in only a few studies, mostly because these studies are difficult to interpret. PD patients generally have lower comorbidity scores at the onset of end-stage renal disease (ESRD), independent of other factors influencing modality selection. Comorbid medical conditions are common in patients with ESRD, and are an important contributing factor to clinical outcomes and quality of life. Depression occurs in about 20-30% of dialysis patients. This is important because of the negative impact depression has on quality of life, but also because depression is now established as a factor that can significantly affect morbidity and mortality in ESRD patients. Sexual life satisfaction showed marked deterioration in all age groups. Patients aged over 65 scored significantly better than younger patients on dialysis stress scales, and were generally more satisfied with life. Longitudinal studies are needed to define periods at risk for decline in HRQoL during progression of CKD.

Sacral Nerve Stimulation for Fecal Incontinence: Long-term Outcomes

Numerous studies advocate the short-term benefits of sacral nerve stimulation for fecal incontinence, but there has been a paucity of studies on longer-term outcomes. The objective of this study was to report the long-term outcome of sacral nerve stimulation performed for fecal incontinence at a single institution. Between January 2004 and May 2007, 53 patients underwent definitive sacral nerve stimulation for fecal incontinence at our institution. Prospectively recorded baseline information, including Wexner incontinence scores and standard short-form (SF-12) health survey scores, were compared with scores at follow-up. Forty-one patients were available for long-term follow-up with a mean duration of 51 months. The median Wexner score decreased from a baseline of 11.5 (range, 3.0-18.0) to 8.0 (range, 0.0-18.0) at follow-up. The mean difference in Wexner score was 2.7 (P < .001). There was no statistically significant change in SF-12 physical scores, but a small but highly significant change occurred in SF-12 mental scores. The median SF-12 mental domain score was 49.5 (range, 15.0-62.1) at baseline, and 57.0 (range, 20.0-64.0) at follow-up, with a mean difference of 4.5 (P = .006). Subgroup analysis performed comparing patients with or without prior intersphincteric silicon biomaterial implants demonstrated a mean difference in Wexner score of -3.5 (no implant) vs 0.0 (previous implant), with P < .09 (not statistically significant). Sacral nerve stimulation results in a statistically significant improvement in fecal incontinence scores in the long term.

Quality of Life in Patients with Small Abdominal Aortic Aneurysm: The Effect of Early Endovascular Repair Versus Surveillance in the CAESAR Trial

Objective: To evaluate and compare changes over time in health-related quality of life reported by patients with small (4.1–5.4 cm) abdominal aortic aneurysms (AAAs) undergoing endovascular aortic aneurysm repair (EVAR) or surveillance. Methods: Participants were randomly assigned to receive either early EVAR or surveillance within a multicentre, randomised clinical trial on small AAA (Comparison of surveillance vs. Aortic Endografting for Small Aneurysm Repair, CAESAR). Patient-reported health-related quality of life was assessed before randomisation, at 6 months and yearly thereafter using the Short Form 36 (SF-36) Health Survey. Results: Between 2004 and 2008, 360 patients (345 males, mean age 68.9 years) were randomised, 182 to early EVAR and 178 to surveillance. There was one perioperative death. Mean follow-up was 31.8 months. No significant difference in survival was found. At baseline, comparable quality of life scores were recorded in both treatment groups: Total SF-36: 73.0 versus 75.5 (p = 0.18), Physical domain: 71.4 versus 73.3 (p = 0.33); Mental health domain: 70.9 versus 72.7 (p = 0.33), in the EVAR arm versus the surveillance arm, respectively. Six months after randomisation, Total SF-36 and Physical and Mental domain scores were all significantly higher with respect to baseline in the EVAR group, while patients of the surveillance group scored lower. The differences between EVAR and surveillance arms in score changes at 6 months were significant and in favour of EVAR: Total score: difference 5.4; p = 0.0017; Physical: difference 3.8; p = 0.02; and Mental: difference 6.0; p = 0.0005. Differences between EVAR and surveillance diminished over time. At the last assessment, patients in both groups had decreased scores with a significant drop with respect to the baseline (−3.9 in EVAR, −6.3 in surveillance). There were no significant differences between the EVAR and surveillance arms: Total score: p = 0.25; Physical: p = 0.47; and Mental: p = 0.38. Conclusions: Patients with small AAA under surveillance compared with early EVAR had significant impaired functional health at 6 months after assignment. After a mean of 31.8 months, SF-36 health-related quality of life in patients allocated to early EVAR and surveillance was similar.

Quality of Life in Patients with Small Abdominal Aortic Aneurysm: The Effect of Early Endovascular Repair Versus Surveillance in the CAESAR Trial

Objective To evaluate and compare changes over time in health-related quality of life reported by patients with small (4.1–5.4 cm) abdominal aortic aneurysms (AAAs) undergoing endovascular aortic aneurysm repair (EVAR) or surveillance. Methods Participants were randomly assigned to receive either early EVAR or surveillance within a multicentre, randomised clinical trial on small AAA (Comparison of surveillance vs. Aortic Endografting for Small Aneurysm Repair, CAESAR). Patient-reported health-related quality of life was assessed before randomisation, at 6 months and yearly thereafter using the Short Form 36 (SF-36) Health Survey. Results Between 2004 and 2008, 360 patients (345 males, mean age 68.9 years) were randomised, 182 to early EVAR and 178 to surveillance. There was one perioperative death. Mean follow-up was 31.8 months. No significant difference in survival was found. At baseline, comparable quality of life scores were recorded in both treatment groups: Total SF-36: 73.0 versus 75.5 ( p = 0.18), Physical domain: 71.4 versus 73.3 ( p = 0.33); Mental health domain: 70.9 versus 72.7 ( p = 0.33), in the EVAR arm versus the surveillance arm, respectively. Six months after randomisation, Total SF-36 and Physical and Mental domain scores were all significantly higher with respect to baseline in the EVAR group, while patients of the surveillance group scored lower. The differences between EVAR and surveillance arms in score changes at 6 months were significant and in favour of EVAR: Total score: difference 5.4; p = 0.0017; Physical: difference 3.8; p = 0.02; and Mental: difference 6.0; p = 0.0005. Differences between EVAR and surveillance diminished over time. At the last assessment, patients in both groups had decreased scores with a significant drop with respect to the baseline (−3.9 in EVAR, −6.3 in surveillance). There were no significant differences between the EVAR and surveillance arms: Total score: p = 0.25; Physical: p = 0.47; and Mental: p = 0.38. Conclusions Patients with small AAA under surveillance compared with early EVAR had significant impaired functional health at 6 months after assignment. After a mean of 31.8 months, SF-36 health-related quality of life in patients allocated to early EVAR and surveillance was similar.