Baseline Mental Component Summary Research Articles

Postoperative improvement in health-related quality of life: a national comparison of surgical treatment for focal (one- to two-level) lumbar spinal stenosis compared with total joint arthroplasty for osteoarthritis

The results of single-center studies have shown that surgical intervention for lumbar spinal stenosis yielded comparable health-related quality of life (HRQoL) improvement to total joint arthroplasty (TJA). Whether these results are generalizable to routine clinical practice in Canada is unknown. The primary purpose of this equivalence study was to compare the relative improvement in physical HRQoL after surgery for focal lumbar spinal stenosis (FLSS) compared with TJA for hip and knee osteoarthritis (OA) across six Canadian centers. A Canadian multicenter ambispective cohort study. A cohort of 371 primary one- to two-level spinal decompression (n=214 with instrumented fusion) for FLSS (n=179 with degenerative lumbar spondylolisthesis [DLS]) was compared with a cohort of primary total hip (n=156) and knee (n=208) arthroplasty for OA. The primary outcome was the change in preoperative to 2-year postoperative 36-Item Short Form Health Survey Physical Component Summary (PCS) score as reflected by the number of patients reaching minimal clinically important difference (MCID) and substantial clinical benefit (SCB). Univariate analyses were conducted to identify baseline differences and factors that were significantly related to outcomes at 2 years. Multivariable regression modeling was used as our primary analysis to compare outcomes between groups. The mean age (years) and percent females for the spine, hip, and knee groups were 63.3/58.5, 66.0/46.9, and 65.8/64.3, respectively. All three groups experienced significant improvement of baseline PCS (p<.001). Multivariate analyses, adjusting for baseline differences (age, gender, baseline Mental Component Summary score, baseline PCS), demonstrated no significant differences in PCS outcome between spinal surgery and arthroplasty (combined hip and knee cohorts) patients with an odds ratio of 0.80 (95% confidence interval [CI], 0.57-1.11; p=.17) and 0.79 (95% CI, 0.58-1.09; p=.15) for achieving MCID or SCB, respectively. In subgroup analysis, spine and knee outcomes were not significantly different, with hip arthroplasty superior to both (p<.0001). Significant improvement in physical HRQoL after surgical treatment of FLSS (including DLS) is consistently achieved nationally. Our overall results demonstrate that a comparable number of patients can expect to achieve MCID and SCB 2 years after surgical intervention for FLSS and total knee arthroplasty.

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 is related to cytokine levels at 12 months in patients with chronic heart failure

Chronic heart failure (CHF) is a condition with a high mortality risk. Besides traditional risk factors, poor health-related quality of life (HRQoL) is also associated with poor prognosis in CHF. Immunological functioning might serve as a biological pathway underlying this association, since pro and anti-inflammatory cytokines are independent predictors of prognosis. The aim of this study was to examine the association between HRQoL at inclusion (baseline) and pro and anti-inflammatory cytokine levels both at baseline and 12 months, using a prospective study design. CHF outpatients completed the Minnesota Living with Heart Failure Questionnaire (MLHFQ) and the Short Form Health Survey 36 (SF-36). Blood samples were drawn at baseline ( n = 111) and 12 months ( n = 127) to measure pro (IL-6, TNFα, sTNFR1, sTNFR2) and anti- (IL1ra, IL-10) inflammatory markers. Linear regression analysis were run for the MLHFQ, the SF-36 mental component summary (MCS) and the physical component summary (PCS), controlling for age, sex, BMI, smoking, co morbidity, NYHA-class and 6 min walk test. Baseline MLHFQ was associated with increased levels of baseline sTNFR2, and 12-month sTNFR1 12 month sTNFR2. Baseline MCS and change in MCS were related to increased 12-month sTNFR1 levels. All significant findings relate a worse HRQoL at baseline or a deterioration over time to increased sTNFR1/2 levels. These findings suggest that immune activation may be one of the pathways underlying the relationship between poor HRQoL and mortality and morbidity in CHF patients. Future studies are warranted to replicate these findings in larger samples.

Evaluation of physical and mental recovery status after elective liver resection

This prospective, clinical pilot trial compared the Short Form 36 Health Survey (SF-36) and a nine-item quality of recovery [Quality of Recovery 9 (QoR-9)] survey to assess the 1-week outcome after liver resection and prediction of postoperative complications from baseline values before liver resection. In 19 patients, the SF-36 was recorded preoperatively (baseline) and on postoperative day (POD) 7. SF-36 z-values (means +/- SD) for the physical component summary (PCS) and mental component summary (MCS) were calculated. QoR-9 (score 0-18) was performed at baseline, POD1, POD3, POD5 and POD7. Descriptive analysis and effect sizes (d) were calculated. From baseline to POD7, PCS decreased from -0.38 +/- 1.30 to -2.10 +/- 0.76 (P = 0.002, d = -1.57) and MCS from -0.71 +/- 1.50 to -1.33 +/- 1.11 (P = 0.061, d = -0.46). QoR-9 was significantly lower at POD1, POD3 and POD5 compared with baseline (P < 0.050, d < -2.0), but not at POD7 (P = 0.060, d = -1.08). Baseline PCS was significantly lower with a high effect size in patients with complications (n = 12) compared with patients without complications (n = 7) (-0.76 +/- 1.46 vs. 0.27 +/- 0.56; P = 0.044, d = -0.84) but not baseline MCS (P = 0.831, d = -0.10) or baseline QoR-9 (P = 0.384, d = -0.44). The SF-36 indicates that liver resection surgery has a higher impact on physical health than on mental health. QoR-9 determines the feasible time course of recovery with a 1-week return to baseline. Preoperative impaired physical health might predict postoperative complications.

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.)

Determinants of Change in Quality of Life from 1 to 6 Months following Acute Stroke

Background and Purpose: Little information is available about change in health-related quality of life (HRQoL) during the first few months following acute stroke, and whether baseline variables can predict who will have the largest improvement in HRQoL. This study assessed the change in HRQoL from 1 to 6 months following acute stroke and the determinants of these changes. Methods:Patients >60 years of age, who had experienced an acute stroke and were admitted to hospital within 24 h of onset, were followed longitudinally. HRQoL was assessed with the Short Form 36 (SF-36) health status questionnaire. Results:Of 550 eligible stroke patients, 315 fulfilled the inclusion criteria and were alive after 30 days. At 1 month, 179 patients responded to the questionnaire, of whom also 140 responded at 6 months following acute stroke. From 1 to 6 months following stroke, all dimensions of the SF-36 improved. The magnitude of change was largest on the role-physical and role-emotional scales and lowest on the bodily pain and mental health scales. Higher physical component summary (PCS) score at 1 month was associated with lower odds of being above the 75th percentile of change in PCS score between the assessments, and higher baseline mental component summary (MCS) score was associated with lower odds of being above the 75th percentile of change in MCS. Treatment in a stroke unit was associated with an increase in the MCS score and higher neurological score with an increase in PCS score of the SF-36. Conclusion: This prospective study showed a considerable improvement in HRQoL from 1 to 6 months after stroke; however, no baseline variables except baseline scores were associated with changes in HRQoL during the 5-month period.

Impact of pre-operative chemotherapy on the quality of life (QL) of patients with resectable non-small cell lung cancer (NSCLC): Experience from the MRC LU22/NVALT/EORTC 08012 multicentre randomised trial

9020 Aim: To evaluate QL during the first 2 years follow-up in patients randomised to receive 3 cycles of platinum-based chemotherapy (CT-S) prior to surgical resection of NSCLC compared to those receiving surgery alone (S). Methods: A total of 519 patients were entered into the LU22 trial from 70 centres in the UK, The Netherlands, Germany and Belgium. All patients were asked to complete the SF-36 QL questionnaire prior to randomisation and at 6 and 12 months then annually to 5 years. The scores from the SF-36 questionnaire were combined into 8 domains and also summarised as physical component summary (PCS) and mental component summary (MCS). The 6,12 and 24 month PCS and MCS scores were analysed using multivariable regression to identify prognostic factors and investigate the difference between the regimens. Results: 82% patients completed QL at baseline, and compliance at 6, 12 and 24 months was 59%, 60% and 67% respectively. Median age was 63 (range 25 to 79 years) and 72% were male. At 6 months patients in the S group reported somewhat better functioning in all domains except general health and mental health, but no differences were seen at 12 or 24 months. The regression analyses indicated that better physical health outcomes (PCS) were predicted by baseline PCS and MCS at all follow-up points (all p&lt;0.05), whereas longer time since surgery predicted better PCS at 6 months (p&lt;0.05), and younger age predicted better PCS at 24 months (p=0.07). For mental health, better MCS was predicted at all time points by baseline MCS (p&lt;0.05). In addition, female gender (p=0.07), and PCS (p&lt;0.05), were predictors at 6 months, and younger age predicted better MCS at 24 months (p&lt;0.01). Treatment regimen had no effect on QL at any time point. At 1 and 2 years more than 50% patients considered their health comparable to others, and 45% were generally optimistic about their future health. Conclusions: Over 2 years follow-up, QL was not adversely affected by pre-operative chemotherapy and there were no significant differences between the regimens. Many patients saw themselves as fit as their contemporaries. [Table: see text]

Health-related quality of life as a predictor of mortality among community-dwelling older persons

Health-related quality of life (HRQOL) measures predict cause-specific mortality, but few studies have explored whether generic self-reported HRQOL measures are independently associated with mortality in community-dwelling older persons. We postulated that a general measure of HRQOL, the short form 36-item questionnaire (SF-36), would be independently predictive of mortality among community-dwelling older persons. To evaluate this hypothesis, we followed a fixed cohort of 4,424 community-dwelling older persons recruited from a 2000 population-based survey in Taiwan until 2003 and investigated whether HRQOL was predictive of 3-year mortality, even after adjusting for traditional clinical risk variables. The data were collected via a door-to-door survey, and interviewers collected information on the subjects' demographics, medical history, utilization of health services, functional ability, falls, and self-reported physical and mental symptoms. Of the 6053 eligible subjects, 4,424 residents agreed to participate in the baseline survey and were contacted in 2003. During the 3-year period, the 3-year cumulative mortality rate for the study population was 5%. Mortality was significantly higher among males (5.57% vs. 4.27%, p = 0.049), and cumulative mortality increased with age (chi (2)-test for trend; chi (2) = 7.734, p = 0.001). For all scales except bodily pain, there was a significant relationship between a 10-point lower baseline score and mortality. Our primary multivariate risk model, which included two summary measures of HRQOL and significant clinical variables, demonstrated that a 10-point decrease in either the baseline Physical Component Summary (PCS) score or the baseline Mental Component Summary (MCS) score was associated with higher mortality (PCS: RR: 1.60, 95% CI: 1.39-1.83; p < 0.001; MCS: RR: 1.16, 95% CI: 1.01-1.34; p = 0.036). The findings suggested that low baseline PCS and MCS scores were important independent risk factors for 3-year mortality among community-dwelling older persons, even after adjusting for other risk factors.

Physical functioning and mental well-being in association with health outcome in patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial II

The association of psychosocial and physical factors with health outcome in patients with congestive heart failure (CHF) has not been fully explored. The aim of this study was to assess the physical and mental health in relationship to health outcome in post-infarction patients with advanced left ventricular dysfunction. A total of 1058 patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial II (MADIT II) completed the Medical Outcome Trust Short Form (SF-12) at baseline. Physical component summary (PCS) and mental component summary (MCS) of SF-12 were analysed in relationship to survival, hospitalization due to CHF, and implantable cardioverter-defibrillator (ICD) therapy. Both baseline PCS and MCS were significantly associated with death (P < 0.001 and P < 0.016, respectively) and hospitalization due to CHF (P <or= 0.001). After adjustment for significant clinical covariates and treatment group, low PCS and low MCS groups remained significant predictors of mortality and CHF hospitalization. Neither PCS nor MCS was associated with appropriate ICD therapy for ventricular tachyarrhythmias. Patients who experienced appropriate ICD shocks had a statistically significant deterioration of PCS but not MCS from baseline to 12 months. Lower baseline PCS and MCS are associated with unfavourable health outcome in MADIT II patients, but not with appropriate ICD therapy for ventricular tachyarrhythmias. Patients who experience ICD shock reported a decrease in PCS, but little or no changes in MCS.

Effects of non-invasive ventilation on survival and quality of life in patients with amyotrophic lateral sclerosis: a randomised controlled trial

Few patients with amyotrophic lateral sclerosis currently receive non-invasive ventilation (NIV), reflecting clinical uncertainty about the role of this intervention. We aimed to assess the effect of NIV on quality of life and survival in amyotrophic lateral sclerosis in a randomised controlled trial. 92 of 102 eligible patients participated. They were assessed every 2 months and randomly assigned to NIV (n=22) or standard care (n=19) when they developed either orthopnoea with maximum inspiratory pressure less than 60% of that predicted or symptomatic hypercapnia. Primary validated quality-of-life outcome measures were the short form 36 mental component summary (MCS) and the sleep apnoea quality-of-life index symptoms domain (sym). Both time maintained above 75% of baseline (T(i)MCS and T(i)sym) and mean improvement (microMCS and microsym) were measured. NIV improved T(i)MCS, T(i)sym, microMCS, microsym, and survival in all patients and in the subgroup with better bulbar function (n=20). This subgroup showed improvement in several measures of quality of life and a median survival benefit of 205 days (p=0.006) with maintained quality of life for most of this period. NIV improved some quality-of-life indices in those with poor bulbar function, including microsym (p=0.018), but conferred no survival benefit. In patients with amyotrophic lateral sclerosis without severe bulbar dysfunction, NIV improves survival with maintenance of, and improvement in, quality of life. The survival benefit from NIV in this group is much greater than that from currently available neuroprotective therapy. In patients with severe bulbar impairment, NIV improves sleep-related symptoms, but is unlikely to confer a large survival advantage.

Change in quality of life in the year following cardiac rehabilitation.

The aim of the present study was to assess change in health-related quality of life (HRQoL) after cardiac rehabilitation in the usual care setting, and to determine predictors for change. In the Post Infarction Care Study, 2441 patients were consecutively included at admission to 18 inpatient cardiac rehabilitation centres following coronary events. HRQoL was assessed with the SF-36 questionnaire at baseline as well as 6 and 12 months after discharge. HRQoL improved significantly in patients after coronary artery bypass grafting (CABG) but not in patients after myocardial infarction. Significant baseline predictors for change of the SF-36 physical component summary (PCS) score were the exercise ECG result at admission (0.59 absolute change/10-watt increase; 95% CI: 0.39, 0.79), an income > or = 1750 euros (1.64; 95% CI: 0.35, 2.93), baseline PCS score (-0.63; 95% CI: -0.69, -0.57), and CABG as indication for admission (3.65; 95% CI: 2.27, 5.04). Significant predictors for change of the mental component summary (MCS) score were age (1.28/10-year increase; 95% CI: 0.62, 1.94), East Germany as area of residence (2.62; 95% CI: 1.32, 3.91), baseline MCS score (-0.58; 95% CI: -0.63, -0.52), and CABG as indication for admission (1.68; 95% CI: 0.36, 3.01). The identification of predictors of HRQoL in the present study may aid in the further development and evaluation of cardiac rehabilitation programmes.

Health-related quality of life as a predictor of mortality following coronary artery bypass graft surgery. Participants of the Department of Veterans Affairs Cooperative Study Group on Processes, Structures, and Outcomes of Care in Cardiac Surgery.

Health-related quality of life has not been evaluated as a predictor of mortality following coronary artery bypass graft (CABG) surgery. Evaluation of health status as a mortality predictor may be useful for preoperative risk stratification. To determine whether the Physical and Mental Component Summary scores from the preoperative Short-Form 36 (SF-36) health status survey predict mortality following CABG surgery after adjustment for known clinical risk variables. Prospective cohort study conducted between September 1992 and December 1996. Fourteen Veterans Affairs hospitals. Of the 3956 patients undergoing CABG surgery only and who were enrolled in the Processes, Structures, and Outcomes of Care in Cardiac Surgery study, the 2480 who completed a preoperative SF-36. All-cause mortality within 180 days after surgery. A total of 117 deaths (4.7%) occurred within 180 days of CABG surgery. The Physical Component Summary of the preoperative SF-36 was a statistically significant risk factor for 6-month mortality after adjustment for known clinical risk factors for mortality following CABG surgery. In multivariate analysis, a 10-point lower SF-36 Physical Component Summary score had an odds ratio (OR) of 1.39 (95% confidence interval [CI], 1.11-1.77; P=.006) for predicting mortality. The SF-36 Mental Component Summary score was not associated with 6-month mortality in multivariate analyses (OR, 1.09; 95% CI, 0.92-1.29; P=.31). The Physical Component Summary score from the preoperative SF-36 is an independent risk factor for mortality following CABG surgery. The baseline Mental Component Summary score does not appear to be predictive of mortality. Preoperative patient self-report of the physical component of health status may be helpful for risk stratification and clinical decision making for patients undergoing CABG surgery.