Baseline Physical Component Summary Scores Research Articles

Long-term effect of increasing water intake on repeated self-assessed health-related quality of life (HRQoL) in autosomal dominant polycystic kidney disease.

The aim of this study was to determine the long-term effect of increasing water intake in patients with autosomal dominant polycystic kidney disease (ADPKD) on longitudinal changes in health-related quality of life (HRQoL) in the setting of a clinical trial. Self-completed HRQoL (using the KDQoL-SF, v.1.3 questionnaire) was assessed annually in participants of a 3-year randomized controlled clinical trial (n=187), allocated (1:1) either to increase water intake to reduce urine osmolality to ≤270 mosmol/kg (implemented by dietetic coaching, self-monitoring tools, text messaging) or continue usual water intake. Overall, 96% and 81.8% of participants (n=187) completed the questionnaire at the baseline and final study visits, respectively. At baseline, the physical component summary score (PCS) and mental component summary score (MCS) were similar in the two groups (P>0.05) and the five dimensions with the lowest scores in both groups were: energy and fatigue; general and overall health; sleep; emotional well-being; and pain. Within each group, there were no longitudinal changes over time. At the final visit, the PCS was higher in the increased water intake group (51.3±7.6, mean±standard deviation) compared to the usual water intake group 48.8±9.3; P=0.037) whereas the MCS was numerically similar. The improvement in the PCS was due to higher sub-scale values for physical functioning and pain (both P<0.05). By multivariate analysis, only baseline PCS and height-corrected total kidney volume were associated with the final PCS (P<0.05). HRQoL scores remained stable over a 3 year period, and were not adversely affected by the intervention to increase water intake. Future studies should evaluate the clinical significance of the higher PCS in the increased water intake group.

Mental and Physical Health-Related Quality of Life Following Military Polytrauma.

The long-term impact of deployment-related trauma on mental and physical health-related quality of life (HRQoL) among military personnel is not well understood. We describe the mental and physical HRQoL among military personnel following deployment-related polytrauma after their discharge from the hospital and examine factors associated with HRQoL and longitudinal trends. The U.S. military personnel with battlefield-related trauma enrolled in the Trauma Infectious Diseases Outcomes Study were surveyed using SF-8 Health Surveys at 1 month post-discharge (baseline) and at follow-up intervals over 2 years. Inclusion in the longitudinal analysis required baseline SF-8 plus responses during early (3 and/or 6 months) and later follow-up periods (12, 18, and/or 24 months). Associations of demographics, injury characteristics, and hospitalization with baseline SF-8 scores and longitudinal changes in SF-8 scores during follow-up were examined. Survey responses were used to calculate the Mental Component Summary score (MCS) and the Physical Component Summary score (PCS). The MCS focuses on vitality, mental health, social functioning, and daily activity limitations, whereas PCS is related to general health, bodily pain, physical functioning, and physical activity limitations. Longitudinal trends in SF-8 scores were assessed using chi-square tests by comparing the median score at each timepoint to the median 1-month (baseline) score, as well as comparing follow-up scores to the immediately prior timepoint (e.g., 6 months vs. 3 months). Associations with the 1-month baseline SF-8 scores were assessed using generalized linear regression modeling and associations with longitudinal changes in SF-8 were examined using generalized linear regression modeling with repeated measures. Among 781 enrollees, lower baseline SF-8 total scores and PCS were associated with spinal and lower extremity injuries (P < .001) in the multivariate analyses, whereas lower baseline MCS was associated with head/face/neck injuries (P < .001). Higher baseline SF-8 total was associated with having an amputation (P = .009), and lower baseline SF-8 total was also associated with sustaining a traumatic brain injury (TBI; P = .042). Among 524 enrollees with longitudinal follow-up, SF-8 scores increased, driven by increased PCS and offset by small MCS decreases. Upward SF-8 total score and PCS trends were associated with time post-hospital discharge and limb amputation (any) in the multivariate analyses (P < .05), whereas downward trends were independently associated with spinal injury and developing any post-discharge infection (P ≤ .001). Patients with lower extremity injuries had lower-magnitude improvements in PCS over time compared to those without lower extremity injuries (P < .001). Upward MCS trend was associated with higher injury severity (P = .003) in the multivariate analyses, whereas downward trends were independently associated with having a TBI (P < .001), time post-hospital discharge (P < .001), and occurrence of post-discharge infections (P = .002). Overall, HRQoL increased during the 2-year follow-up period, driven by PCS improvement. Increasing HRQoL was associated with time since hospital discharge and limb amputation, whereas a downward trend in HRQoL was associated with spinal injury and post-discharge infection. The longitudinal decline in MCS, driven by TBI occurrence, time since hospital discharge, and developing post-discharge infections, emphasizes the importance of longitudinal mental health care in this population.

Identifying coronary artery bypass grafting patients at high risk for adverse long-term prognosis using serial health-related quality of life assessments.

Patients who undergo coronary artery bypass grafting (CABG) are known to be at a significant risk of experiencing long-term adverse events, emphasizing the importance of regular assessments. Evaluating health-related quality of life (HRQoL) serves as a direct method to gauge prognosis. Our objective is to ascertain the prognostic significance of consecutive HRQoL assessments using the Physical Component Summary (PCS) and Mental Component Summary (MCS) derived from the Short-Form 36 (SF-36) health survey in CABG patients. The study population consisted of 433 patients who underwent isolated elective CABG at Fuwai Hospital between 2012 and 2013. SF-36 assessments were conducted during both the hospitalization period and follow-up. The primary endpoint of the study was all-cause mortality, while the secondary outcome was a composite measure including death, myocardial infarction, stroke, and repeat revascularization. We assessed the relationships between the PCS and MCS at baseline, as well as their changes during the first 6 months after the surgery (referred to as ΔPCS and ΔMCS, respectively), and the observed outcomes. The patients were followed for an average of 6.28 years, during which 35 individuals (35/433, 8.1%) died. After adjusting for clinical variables, it was observed that baseline MCS scores (hazard ratio [HR] for a 1-standard deviation [SD] decrease, 1.57; 95% confidence interval [CI], 1.07-2.30) and ΔMCS (HR for a 1-SD decrease, 1.67; 95% CI, 1.09-2.56) were associated with all-cause mortality. However, baseline PCS scores and ΔPCS did not exhibit a significant relationship with all-cause mortality. Notably, there was a dose-response relationship observed between ΔMCS and the likelihood of all-cause mortality (HRs for the 2nd, 3rd and 4th quartiles compared to the 1st quartile, 0.33, 0.45 and 0.11, respectively). Baseline MCS and changes in MCS were independent predictors for long-term mortality of CABG. Better mental health status and recovery indicated better prognosis.

Derivation and external validation of a risk score for clinically important declines in health and function among two longitudinal cohorts of women in the mid-life

ObjectivesWomen in mid-life often develop chronic conditions and experience declines in physical health and function. Identifying factors associated with declines provides opportunity for targeted interventions. We derived and externally validated...

Rapid decline in kidney function is associated with rapid deterioration of health-related quality of life in chronic kidney disease

This study aimed to evaluate changes in health-related quality of life (HRQOL) in patients with chronic kidney disease (CKD) according to decline in kidney function. HRQOL was assessed using the Short Form-36 questionnaire composed of a physical component summary (PCS) and mental component summary (MCS). Rapid decline in kidney function was defined as a decline in the estimated glomerular filtration rate (eGFR) of > 3 mL/min/1.73 m2/year. Rapid deterioration of HRQOL was defined a change in the HRQOL value greater than the median. Among 970 patients, 360 (37.1%) were in the rapid kidney function decline group. In 720 patients who were 1:1 propensity score-matched, the baseline eGFR was not significantly different between the non-rapid and rapid kidney function decline groups. Compared with the baseline PCS score, the 5-year PCS score decreased in the non-rapid and rapid kidney function decline groups. The 5-year MCS score significantly decreased in the rapid kidney function decline group alone. Rapid decline in kidney function was significantly associated with rapid deterioration of the PCS (odds ratio [OR]: 1.48; 95% confidence interval [CI]: 1.07–2.05; P = 0.018) and MCS (OR: 1.89; 95% CI 1.36–2.62; P < 0.001) scores. Rapid decline in kidney function was associated with rapid deterioration of HRQOL in patients with CKD.

Health-Related Quality of Life in Adults With Adolescent- and Adult-Onset Systemic Lupus Erythematosus: A Longitudinal Study of a Multiethnic US Cohort.

The long-term impact of childhood-onset systemic lupus erythematosus (SLE) on health-related quality of life (HRQoL) in adult SLE patients in comparison to those with adult-onset SLE is unknown. We aim to examine and compare HRQoL trajectories in adults with adolescent- and adult-onset SLE. Patients enrolled in the LUpus in MInorities: NAture versus Nurture cohort were included. Adolescent-onset SLE were those diagnosed before 24 years of age, and adult-onset SLE were those diagnosed otherwise. Sociodemographic, clinical, medications, behavioral/psychological, and functioning data were obtained. Longitudinal trajectories of the physical component summary (PCS) and the mental component summary (MCS) Short Form 36 health survey scores were compared between the groups using a linear mixed model accounting for time-dependent and independent covariates. A total of 470 SLE patients were included (95 with adolescent-onset SLE and 375 with adult-onset SLE). The mean ± SD age at diagnosis was 19.7 ± 2.8 years in the adolescent group and 39.3 ± 11.0 years in the adult group. The baseline PCS scores were higher (better physical functioning) in adolescent-onset SLE than in adult-onset SLE (38.9 versus 34.3, respectively; P < 0.001); however, the baseline MCS scores were comparable between the groups (41.4 versus 40.5, respectively; P=0.53). The HRQoL improved equally in both groups with no statistically significant difference within and between the groups (last mean PCS and MCS scores 43.9 and 45.3 in adolescent-onset SLE; 38.1 and 43 in adult-onset SLE). Adults with adolescent-onset SLE exhibited better physical functioning than those in the adult SLE group, despite more severe disease; noteworthy, HRQoL was below the general US population, despite clinically meaningful improvement in HRQoL over time in both groups.

Factors Associated With 10-Year Declines in Physical Health and Function Among Women During Midlife

Women in midlife often develop chronic conditions and experience declines in physical health and function. Identifying factors associated with declines in physical health and function among these women may allow for targeted interventions. To examine the factors associated with clinically important 10-year declines in the physical component summary score (PCS) of the Short Form 36 (SF-36), a widely used patient-reported outcome measure, in women in midlife. This longitudinal cohort study collected data from geographically dispersed sites in the US. Participants were part of the Study of Women's Health Across the Nation (SWAN), a racially and ethnically diverse cohort of women enrolled at or immediately before the menopause transition. Women have been followed for up to 21 years, between 1996 and 2016, with annual visits. Data were analyzed from October 2020 to March 2021. Demographic indicators, health status measures, and laboratory and imaging assessments. The main outcome was a clinically important decline (≥8 points) on the PCS, based on the 10-year difference in scores between ages 55 and 65 years. From the SWAN cohort of 3302 women, 1091 women (median [IQR] age, 54.8 [54.3-55.4] years; 264 [24.2%] Black women; 126 [11.6%] Chinese women; 135 [12.4%] Japanese women; 566 [51.9%] White women) were eligible for analyses based on duration of follow-up and availability of SF-36 data. At age 55, women had a median (IQR) body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 27.0 (23.2-32.6), a median (IQR) baseline PCS of 53.1 (46.8-56.7), 108 women (9.9%) were current smokers, and 938 women (86.3%) had at least 1 comorbidity. Between ages 55 and 65 years, the median (IQR) change in PCS was -1.02 (-6.11 to 2.53) points with 206 women (18.9%) experiencing declines of 8 points or more. In multivariable models, factors associated with clinically important decline included higher baseline PCS (odds ratio [OR], 1.08; 95% CI, 1.06-1.11), greater BMI (OR, 1.06; 95% CI, 1.03-1.09), less educational attainment (OR, 1.87; 95% CI, 1.32-2.65), current smoking (OR, 1.93; 95% CI, 1.14-3.26), osteoarthritis (OR, 1.46; 95% CI, 1.01-2.09), clinically significant depressive symptoms (OR, 2.03; 95% CI, 1.34-3.09), and cardiovascular disease (OR, 2.06; 95% CI, 1.26-3.36). In this cohort study, clinically important declines in women's physical health and function were relatively common between ages 55 and 65 years. Several variables associated with these declines were identified as potentially useful components in a clinical score identifying women at increased risk of physical health and functional declines.

Minimum clinically important change for outcome scores among patients aged 75 or over undergoing lumbar spine surgery.

To elucidate the minimum clinically important change (MCIC) of the physical component summary (PCS) of the Short Form-12, Oswestry Disability Index (ODI), EuroQOL-5 dimensions (EQ-5D), and the Core Outcome Measures Index (COMI) in patients aged ≥ 75years undergoing lumbar spine surgery. We retrospectively reviewed patients aged ≥ 75years with degenerative lumbar spine disease who underwent lumbar spine decompression or fusion surgery within three levels between April 2017 and June 2018. We also evaluated patients aged < 75years in the same period as reference. We evaluated the baseline and postoperative PCS, ODI, EQ-5D, and COMI scores. Patients were asked to answer an anchor question regarding health transition for MCICs using the anchor-based method. A total of 247 patients aged ≥ 75years and 398 patients aged < 75years were included for analysis. Of patients aged ≥ 75years, 83.4% showed at least "somewhat improved" outcomes, while 91.0% of patients aged < 75years reported this outcome. PCS change score was not adequately correlated to health transition in patients aged ≥ 75years. Receiver operating characteristic curve analyses revealed MCICs of 17.8 for ODI, 0.18 for EQ-5D, and 1.6 for COMI in patients aged ≥ 75years, and 12.7 for ODI, 0.19 for EQ-5D, and 2.3 for COMI in patients aged < 75years. In patients aged ≥ 75years, PCS may not be feasible for evaluation of health transition. The MCIC value for ODI score was higher and that for EQ-5D/COMI score was lower in patients aged ≥ 75years, compared with those in patients aged < 75years.

Impact of Adrenalectomy on Cortisol-Producing Adenoma: Longitudinal Evaluation of Health-Related Quality of Life following Laparoscopic Adrenalectomy

Introduction: There is increasing interest in evaluating the quality of life of patients with cortisol-producing adrenocortical adenoma (CPA). Our objective was to assess patient-reported health-related quality of life (HRQOL) in patients with CPA compared to non-CPA. Methods: Between January 2012 and September 2015, a total of 24 and 62 patients who had laparoscopic adrenalectomy with CPA and non-CPA, respectively, were included in the study. General HRQOL was evaluated on Short Form 8 (SF-8) questionnaire. The SF-8 questionnaire was administered at preoperative baseline and at 3, 6, 9, 12, 18, and 24 months after adrenalectomy. The impact of changing 2 measures of the summary score on the physical component summary (PCS) and mental component summary (MCS) score of SF-8 was evaluated in prospective and longitudinal studies. Results: The baseline PCS score was significantly lower in the CPA than in the non-CPA group (43.6 vs. 49.0; p = 0.0075). Thereafter, the PCS score was significantly lower in the CPA group at 3, 6, 9, and 12 months postoperatively. The PCS score increased in the CPA group with no significant difference between both groups at 18 months (48.1 vs. 50.2; p = 0.1202) and 24 months (48.0 vs. 50.8; p = 0.3625) postoperatively. However, the baseline MCS score was not significantly different between the CPA and non-CPA group. The MCS score in both groups gradually increased with no significant differences between the groups at any time points after surgery. The PCS score was not significantly improved at all postoperative points than the baseline score in the CPA and non-CPA group. The MCS score was significantly improved than the baseline score from 6 months postoperatively only in the CPA group. Conclusion: Our research suggests that laparoscopic adrenalectomy may contribute to improving the physical and mental function in HRQOL.

Different Effects of Pulmonary Vein Isolation on Quality of Life Between Patients with Persistent and Paroxysmal Atrial Fibrillation.

The effect of restoring sinus rhythm by pulmonary vein isolation (PVI) on the quality of life (QOL) of patients with persistent atrial fibrillation (PerAF) has not been adequately investigated. This study was performed to compare the changes in QOL after extended PVI between patients with PerAF and paroxysmal AF (PAF).Patients with PAF (n = 38) and PerAF (n = 22) who underwent their first PVI and developed no AF recurrence 6 months after PVI were enrolled. QOL surveys were performed at baseline and 6 months post-ablation using Short Form-36 surveys.The mental component summary score (MCS) (53.4 ± 10.2 to 56.5 ± 7.1, P = 0.019) and physical component summary score (PCS) (46.1 ± 10.6 to 48.5 ± 8.3, P = 0.015) improved after PVI in the PAF group. The PCS, but not the MCS, improved after PVI in the PerAF group (45.8 ± 7.9 to 51.5 ± 6.2, P < 0.001). Changes in the PCS were greater in the PerAF group than in the PAF group (8.6 ± 6.9 versus 2.8 ± 5.2, P = 0.009). Multivariate regression analysis demonstrated that a low baseline MCS and the type of AF (PAF) were independent predictors of an increased MCS and that a low baseline PCS and the type of AF (PerAF) were independent predictors of an increased PCS.The changes in QOL differed between PAF and PerAF after PVI. Although most patients with PerAF were asymptomatic before PVI, their improvement in physical QOL was greater than that in patients with PAF. Such beneficial effects on physical QOL are likely expected in patients with PerAF with a low PCS before PVI.

Predictors of Long-Term Temporomandibular Disorder Pain Intensity: An 8-Year Cohort Study.

To investigate, in individuals with pain-related temporomandibular disorder (TMD), the association of long-term pain intensity with baseline health-related quality of life (HRQoL) and jaw functional limitation. Of 513 cases with baseline pain-related TMD (masticatory muscle and/or temporomandibular joint [TMJ] pain), 273 were reevaluated after 8 years, and 258 of them had complete baseline data for Jaw Functional Limitation Scale (JFLS) scores and HRQoL measured by the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the 12-item Short Form Health Survey and follow-up data for Characteristic Pain Intensity (CPI) from the Graded Chronic Pain Scale. Secondary analyses of existing data quantified the effects of primary (PCS, MCS) and secondary (JFLS) predictors on follow-up CPI by using multivariable linear regression. Sensitivity analyses considered differences between the included participants (n = 258) and those who were not included (n = 255) by using inverse probability weighting. Interactions of baseline predictors with age, sex, and baseline CPI were evaluated using multivariable linear regression. The score for baseline PCS, but not MCS or JFLS, was associated with follow-up CPI (P = .012). One standard deviation (SD = 9.0)-higher baseline PCS score predicted an overall 3.2-point-lower follow-up CPI (95% confidence interval -5.8 to -0.7) after adjusting for age, sex, MCS, JFLS, and baseline CPI scores. However, the effect of PCS score was not uniform: the association between PCS and follow-up CPI scores was statistically significant for participants with baseline CPI ≥ 51.3/100 and clinically significant for participants with baseline CPI ≥ 68.7/100. Adjustment for TMD treatments and sensitivity analyses had negligible effect. In participants with moderate to severe baseline TMD pain intensity, higher baseline physical HRQoL predicted lower TMD pain intensity at 8 years follow-up. PCS score could contribute to a multifactorial long-term TMD pain prediction model.

Change in Patient-Reported Outcomes in Single-Unit Transfusion Comparable with Double-Unit Transfusion

▪IntroductionPatient blood management was developed to reduce allogeneic blood exposure and enhance patient outcomes. If transfusion is required in stable and non-bleeding hospitalized patients, prescribing one unit of red blood cells (RBC) followed by reassessment of clinical condition is recommended. Double-unit RBC transfusion, the routine practice in the past, is still widely practiced despite the advocate of restrictive transfusion strategy. One of the reasons could be a lack of evidence to support the optimal number of RBC units per transfusion. Blood transfusion is often performed to alleviate anemic symptoms. However, patient-reported outcomes were seldom measured to evaluate transfusion requirements.MethodThis was a single-center prospective study conducted during Mar to Jun 2016 in the medical department of a regional hospital of Hong Kong. Day-care and hospitalized patients requiring RBC transfusion were recruited. Patients with active bleeding or unstable hemodynamics were excluded. Subjects' demographics, recent transfusion history, comorbidities, transfusion trigger and the number of RBC units transfused were obtained. Patient-reported outcomes were measured on the day of transfusion (Day 0), and on Day 1 and 7 post-transfusion. Two health-related quality of life (HRQOL) instruments, i.e. Short-form 12 version 2 (SF12v2) and Functional Assessment of Cancer Therapy Anemia Subscale (FACT-AnS) in traditional Chinese, were administered to measure the general health status and anemic symptoms respectively. Physical Component Summary (PCS) and Mental Component Summary (MCS) scores were then derived from SF12v2. The number of RBC units transfused in one week and post-transfusion hemoglobin (Hb) level were evaluated. Linear regressions were performed to study the relationship between the changes in PCS, MCS and FACT-AnS on Day 1 and Day 7 from Day 0 with the number of RBC units transfused. Factors associated with the number of RBC units transfused were controlled. Other predictors of the changes in HRQOL were included in the regression analysis.Results34 day-care and 67 hospitalized patients were recruited with HRQOL surveys completed on Day 0. The surveys were completed by 97 patients on Day 1 and 78 patients on Day 7. Forty-seven patients (47%), who were transfused with 2 or more units of RBC, were classified as double-unit group. The median transfusion trigger was 7.6 [IQR 7.0 - 7.9] g/dL in the single-unit group and 7.0 [IQR 6.2 - 7.8] g/dL in the double-unit group (p < 0.05). There was a trend of higher Charlson’s Comorbidity Index (CCI) (p = 0.09) in the single-unit group. Baseline PCS, MCS and FACT-AnS scores on Day 0 were comparable in both groups (p = 0.35, 0.45 and 0.15 respectively).The changes in HRQOL of all subjects were summarized in Table 1. FACIT-AnS improved after transfusion but the effect size was small (Cohen’s d < 0.5). There was improvement of PCS on Day 7. The change of MCS was non-significant.The mean number of transfused RBC in one week was 0.7 units less in the single-unit group (p < 0.001). The post-transfusion Hb level was 0.9g/dL (95% CI: 0.3, 1.6) and 1.1g/dL (95% CI: 0.2, 1.9) higher in the double-unit group on Day 1 and Day 7 respectively.Having controlled for transfusion trigger, CCI and RBC transfused during Day 1 to Day 7, the changes in HRQOL were not associated with the number of RBC units transfused (Table 2). Day-care patients had greater improvement in HRQOL on Day 1 but not on Day 7. The improvement of HRQOL in those having worse baseline scores was more significant. RBC use in the past 7 days was not associated with the change in patient-reported outcomes.ConclusionDouble-unit RBC transfusion was frequently performed, especially in patients with a lower Hb level. Blood transfusion could improve anemic symptoms but the effect on general health status was insignificant during early follow-up. The average number of RBC units transfused in one week was 28% less in the single-unit group. Post-transfusion Hb level was higher after double-unit transfusion, but there was no evidence it led to more significant improvement in patient-reported outcomes. Day-care patients had earlier improvement in HRQOL but the effect disappeared after one week. Patients with worse symptom score at baseline had greater improvement in HRQOL. It is proposed that the practice of single-unit RBC transfusion is appropriate in terms of alleviating anemic symptoms and reducing overall blood use. [Display omitted] [Display omitted] DisclosuresNo relevant conflicts of interest to declare.

Polypharmacy and Health-Related Quality of Life Among US Adults With Arthritis, Medical Expenditure Panel Survey, 2010-2012.

IntroductionOur objective was to determine the relationship between polypharmacy (treatment with prescription drugs from 6 or more drug classes concurrently) and health-related quality of life (HRQoL) among US adults with arthritis.MethodsWe conducted a retrospective cohort study that used 2-year longitudinal data from the Medical Expenditure Panel Survey to analyze a cohort of 6,132 adults aged over 21 years with arthritis. Measures of HRQoL were the summary scores from the mental component summary (MCS) and physical component summary (PCS) of the 12-item short-form health survey. Unadjusted and adjusted regression models were used to evaluate the association between polypharmacy and HRQoL measures. We used SAS, version 9.4, (SAS Institute Inc) to conduct all analyses.ResultsIn unadjusted analyses, adults with arthritis taking prescription drugs from 6 or more drug classes concurrently had significantly lower MCS and PCS scores (β, −3.11, P < .001 and β, −10.26, P < .001, respectively) than adults taking prescription drugs from fewer than 6. After controlling for the demographic characteristics, number of mental and physical chronic conditions, and baseline MCS and PCS scores, adults taking prescription drugs from 6 or more drug classes concurrently had significantly lower PCS scores (β, −1.68, P < .001), than those taking prescription drugs from fewer than 6. However, no significant difference in MCS scores was found between adults taking prescription drugs from 6 or more drug classes concurrently and those taking prescription drugs from fewer than 6 (β, −0.27, P = .46).ConclusionPolypharmacy is significantly associated with lower PCS scores among adults with arthritis. Because polypharmacy can lead to drug–drug and drug–disease interactions, health care providers need to consider the risk and adopt a cautious approach in prescribing multiple drugs to manage chronic conditions and in choosing therapies to improve HRQoL among adults with arthritis.

Baseline predictors of health-related quality of life after anterior cruciate ligament reconstruction: a longitudinal analysis of a multicenter cohort at two and six years.

Limited information exists regarding predictors of general quality of life following anterior cruciate ligament (ACL) reconstruction with up to six-year follow-up. We hypothesized that certain variables evaluated at the time of ACL reconstruction will predict the general quality of life as measured by the Short Form-36 (SF-36). All unilateral ACL reconstructions from 2002 to 2004 in patients currently enrolled in a prospective multicenter cohort were evaluated. Patients preoperatively completed the SF-36 validated outcome instrument. Surgeons documented intra-articular pathological conditions and treatment, as well as the ACL reconstruction surgical technique. At baseline and at a minimum of two and six years postoperatively, patients completed the SF-36. Longitudinal analysis was performed for the two-year and six-year end points. Of the initial 1512 subjects, at least one follow-up questionnaire was obtained from 1411 subjects (93%). The cohort was 44% female, and the median patient age at enrollment was twenty-three years. The mean scores were 41.9 points for the Physical Component Summary (PCS) and 51.7 points for the Mental Component Summary (MCS) at baseline, 53.6 points for the PCS and 52.0 points for the MCS at two years, and 54.0 points for the PCS and 52.4 points for the MCS at six years. Significant predictors of a higher PCS score were a higher baseline PCS score, younger age, lower baseline body mass index, having >50% of the lateral meniscus excised, or having no treatment done on a lateral meniscal tear. In contrast, significant predictors of a lower PCS score were a shorter follow-up time since surgery, revision ACL reconstruction, smoking at baseline, fewer years of education, and chondromalacia of the lateral tibial plateau. The mean utility gained at six years after ACL reconstruction was 5.3 quality-adjusted life years (QALYs). Large improvements in the PCS (with an effect size of 1.2) were noted at two years and were maintained at six years after ACL reconstruction. Lower education and smoking were significant predictors of lower PCS and MCS scores. ACL reconstruction resulted in a relatively high gain of QALYs.

Analysis of longitudinal quality-of-life data in high-risk operable patients with lung cancer: Results from the ACOSOG Z4032 (Alliance) multicenter randomized trial

BackgroundPrior studies have suggested that low baseline quality-of-life (QOL) scores predict worse survival in patients undergoing lung cancer surgery. However, these studies involved average-risk patients undergoing lobectomy. We report QOL results from a multicenter trial, American College of Surgeons Oncology Group Z4032, which randomized high-risk operable patients to sublobar resection (SR), or SR with brachytherapy, and included longitudinal QOL assessments. MethodsGlobal QOL, using the 36-item Short-Form Health Survey (SF36), and the dyspnea score from the University of California, San Diego Shortness of Breath Questionnaire (SOBQ) scale, was measured at baseline, 3, 12, and 24 months. SF36 physical component summary (PCS) and mental component summary (MCS) scores were standardized and adjusted for age and gender normals, with scores <50 indicating below-average health status. SOBQ scores were transformed to a 0-100 (poor-excellent) scale. Aims were to: (1) determine the impact of baseline scores on recurrence-free survival, overall survival, and 30-day adverse events (AEs); and (2) identify subgroups (surgical approach, resection type. tumor location, tumor size, respiratory function) with a ≥10-point decline or improvement in QOL after SR. ResultsTwo hundred twelve eligible patients were included. There were no significant differences in baseline QOL scores between arms. Median baseline PCS, MCS, and SOBQ scores were 42.7, 51.1, and 70.8, respectively. There were no differences in grade-3+ AEs, overall survival, or recurrence-free survival in patients with baseline scores ≤median versus >median values, except for a significantly worse overall survival for patients with baseline SOBQ scores ≤median value. There were no significant differences between the study arms in percentage change of QOL scores from baseline to 3, 12, or 24 months. Further comparison combining the 2 arms demonstrated a higher percentage of patients with a ≥10-point decline in SOBQ scores with segmentectomy compared with wedge resection (40.5% vs 21.9%, P = .03) at 12 months, with thoracotomy versus video-assisted thoracic surgery (VATS) (38.8% vs 20.4%, P = .03) at 12 months, and T1b versus T1a tumors (46.9% vs 23.5%, P = .020) at 24 months. A ≥10-point improvement in PCS score was seen at 3 months with VATS versus thoracotomy (16.5% vs 3.6%, P = .02). ConclusionsIn high-risk operable patients, poor baseline QOL scores were not predictive for worse overall or recurrence-free survival, or for higher risk for AEs following SR. VATS was associated with improvement in physical function at 3 months, and improved dyspnea scores at 12 months, lending support for the preferential use of VATS when SR is undertaken.

Association between baseline physical function and comorbidity status with patient-reported quality of life after prostate cancer treatments: Combined analysis of two prospective cohort studies.

6107 Background: Treatment-related bowel, urinary, and sexual dysfunction in prostate cancer patients varies by treatment type, baseline function and other patient factors. To better predict patient outcomes after treatment, we examined the impact of comorbidity on these quality of life (QOL) outcomes in a secondary data analysis of two pooled, prospective cohort studies. Methods: A total of 697 patients from 3 academic hospitals who received radical prostatectomy, external beam radiation, or brachytherapy were included. Using a validated instrument, patients reported bowel, urinary, and sexual symptoms pretreatment, and at 3, 12, 24, and 36 months after treatment. Baseline physical function was measured by the physical component summary score (PCS) of the SF-12 using patient report. Comorbidity as measured by the Index of Co-Existent Disease (ICED) was obtained from medical record review. Repeated QOL measurements were analyzed using a mixed modeling method, by random coefficient modeling. Separate models were built for each outcome using bowel, urinary, and sexual scale scores at each time point.Covariates in all models included baseline age, education, ICED, and PCS. Results: Approximately 70% of patients had one or more comorbid conditions at baseline. After adjusting for age and education in mixed-models, we found baseline comorbidity was independently associated with more sexual dysfunction (p&lt;.001) and urinary incontinence (p=.03). Worse baseline physical functioning was independently associated with more bowel problems (p&lt;.001) and sexual dysfunction (p&lt;.001). There were no treatment by comorbidity or physical functioning interactions. Conclusions: Comorbidity and worse physical functioning at baseline are significantly associated with poorer bowel, urinary, and sexual function after treatment for prostate cancer, but the associations do not appear to differ by treatment. Patients with comorbidity recovered more slowly. This information may help patients and their physicians anticipate outcomes after surgical and radiation treatments.

Predictors of Quality of Life in Chinese Patients with Acute Coronary Syndrome

Predictors of quality of life in Chinese patients with acute coronary syndrome remain unknown. Between January 2006 and March 2009, a prospective cohort study of 782 patients with acute coronary syndrome was carried out, with follow-up 7 months later. Depression and anxiety symptoms were measured using the Hospital Anxiety and Depression Scale. Quality of life was assessed using the 36-Item Short-Form Health Survey. To identify predictors of decreased quality of life, both the physical and mental component summary scores were analyzed using multiple and ordinal logistic regression. In our quality-of-life model, diabetes mellitus was an independent risk factor for a low mental component summary score. Anxiety symptoms and the baseline mental component summary score were significant independent predictors of a low mental component summary score. Acute myocardial infarction was found to be a risk factor for a low physical component summary score. Anxiety symptoms, baseline physical component summary score, and systolic blood pressure on admission were significant independent predictive factors. Among patients with acute coronary syndrome, those with acute myocardial infarction, diabetes, or a low baseline quality of life need more care and effective intervention to improve their quality of life.

Health-related quality of life and survival in liver transplant candidates

Health-related quality of life (HRQOL) is an important measure of the effects of chronic liver disease in affected patients that helps guide interventions to improve well-being. However, the relationship between HRQOL and survival in liver transplant candidates remains unclear. We examined whether the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from the Short Form 36 (SF-36) Health Survey were associated with survival in liver transplant candidates. We administered the SF-36 questionnaire (version 2.0) to patients in the Pulmonary Vascular Complications of Liver Disease study, a multicenter prospective cohort of patients evaluated for liver transplantation in 7 academic centers in the United States between 2003 and 2006. Cox proportional hazards models were used with death as the primary outcome and adjustment for liver transplantation as a time-varying covariate. The mean age of the 252 participants was 54 +/- 10 years, 64% were male, and 94% were white. During the 422 person years of follow-up, 147 patients (58%) were listed, 75 patients (30%) underwent transplantation, 49 patients (19%) died, and 3 patients were lost to follow-up. Lower baseline PCS scores were associated with an increased mortality rate despite adjustments for age, gender, Model for End-Stage Liver Disease score, and liver transplantation (P for the trend = 0.0001). The MCS score was not associated with mortality (P for the trend = 0.53). In conclusion, PCS significantly predicts survival in liver transplant candidates, and interventions directed toward improving the physical status may be helpful in improving outcomes in liver transplant candidates.

Milnacipran improves health-related quality of life in patients with fibromyalgia (FM): results from a pivotal phase III randomized controlled trial

Fibromyalgia (FM) is associated with multiple impairments. A pivotal milnacipran clinical trial was analyzed for impact on SF-36 domains. Patients received milnacipran 100 mg/day, 200 mg/day, or placebo for 15 weeks (N = 1196). Health-related quality of life (HRQOL) improvements were evaluated using SF-36 Physical Component Summary (PCS), Mental Component Summary (MCS), and individual domain scores at each visit. Baseline PCS scores were found to be approximately 2 standard deviations (SDs) lower than age- and gender-matched US norms (17.6-18.1 point decrements). Baseline MCS scores reflected less impairment (7.1-9.3 point decrements; within 1 SD of norms). Individual domain scores with the greatest baseline impairments were vitality, bodily pain, role physical, and physical functioning. At endpoint, all groups achieved clinically meaningful improvements (≥MCID of 2.5-5.0 points) in PCS scores, with values approaching 1 SD of norms. Least square mean improvements in PCS scores at Week 15 were observed in 100 and 200 mg/day milnacipran-treated patients vs placebo (5.14 and 4.46 vs 3.28, respectively), with significant improvement observed with 100 mg/day (P < .01). Significant improvements >MCID of 5-10 points were evident in physical functioning and bodily pain in milnacipran-treated patients versus placebo (100 mg/day, P < .001; 200 mg/day, P < .01). Endpoint MCS scores approached norms of 50: 46.9 (milnacipran 100 mg/day) and 47.3 (milnacipran 200 mg/day) vs 46.1 (placebo), with significantly greater improvements in patients treated with milnacipran 200 mg/day (P < .05 vs placebo). Endpoint improvements greater than the MCID and significantly greater than placebo were evident with milnacipran 200 mg/day in role emotional (P < .05) and mental health (P < .05) domains; vitality domain scores were significantly improved with milnacipran 100 mg/day versus placebo (P < .01). Treatment with milnacipran resulted in SF-36 domain and MCS scores which approached age- and gender-matched US norms, despite large and clinically significant decrements at baseline. (Supported by Forest Laboratories, Inc. and Cypress Bioscience, Inc.)

A prospective study of the impact of comorbid medical disease on bipolar disorder outcomes

Background Several studies suggest that medical comorbidity is associated with worse clinical status in bipolar disorder. It is unclear which aspect of medical comorbidity is responsible: simple disease count, risk for future morbidity, or current physical burden. Methods We analyzed three years of prospective data from a randomized clinical trial of collaborative care in 306 bipolar veterans. We examined the association of clinical outcome with baseline medical comorbidity defined as: (1) simple active disease count, (2) diseases with risk for future morbidity measured with the Charlson Comorbidity Index, and (3) current physical burden measured with the SF-36 Physical Component Summary score (PCS). Bipolar outcomes were weeks in episode, mean depression score, and change in mental health burden measured by the SF-36 Mental Component Summary score (MCS). Results The three medical comorbidity measures were not highly correlated, indicating that each conveyed novel information. Controlling for potential confounders, worse baseline PCS predicted significantly higher mean depression scores ( p = 0.011) and less improvement in MCS scores ( p = 0.0099) over three years. Simple disease count and risk for future risk did not predict worse bipolar outcomes. Limitations Some potential limitations include not accounting for all confounding factors, selection bias for participants, increased the likelihood of Type I error due to multiple comparisons and having a predominantly male population. Conclusions This long-term prospective study extends cross-sectional and retrospective research on the link between medical illness and bipolar outcomes. It is the current experience of burden of physical illness, rather than an unweighted or weighted disease count, that leads to worse bipolar outcomes.