Survey Physical Component Summary Scores Research Articles

Helicobacter pylori Eradication in Functional Dyspepsia

Eradication of Helicobacter pylori in patients with functional dyspepsia continues to be a matter of debate. We studied eradication effects on symptoms and quality of life of primary care patients. Helicobacter pylori -positive adult patients with functional dyspepsia meeting the Rome III International Consensus criteria were randomly assigned to receive omeprazole, amoxicillin trihydrate, and clarithromycin, or omeprazole plus placebo for 10 days. Endoscopy and H pylori tests were performed at screening and at 12 months. Outcome measures were at least 50% symptomatic improvement at 12 months using a validated disease-specific questionnaire (primary end point), patient global assessment of symptoms, and quality of life. We randomly assigned 404 patients (78.7% were women; mean age, 46.1 years); 201 were assigned to be treated with antibiotics (antibiotics group) and 203 to a control group. A total of 389 patients (96.3%) completed the study. The proportion of patients who achieved the primary outcome was 49.0% (94 of 192) in the antibiotics group and 36.5% (72 of 197) in the control group (P = .01; number needed to treat, 8). In the patient global assessment of symptoms, 78.1% in the antibiotics group (157 of 201) answered that they were better symptomatically, and 67.5% in the control group (137 of 203) said that they were better (P = .02). The antibiotics group had a significantly larger increase in their mean (SD) Medical Outcomes Study 36-Item Short Form Health Survey physical component summary scores than the control group did (4.15 [8.5] vs 2.2 [8.1]; P = .02). Helicobacter pylori eradication provided significant benefits to primary care patients with functional dyspepsia. clinicaltrials.gov Identifier: NCT00404534.

Quality of life and perceived health status in adults with congenitally corrected transposition of the great arteries

The purpose of this study is to assess perceived health status and quality of life in adults with congenitally corrected transposition of the great arteries who have not undergone anatomic repair. Quality of life as measured by the satisfaction with life scale and linear analog scales and perceived health status as measured by the Short Form 36 Health Survey (version 1) were evaluated in 25 adults with congenitally corrected transposition and compared with a control group of 25 adults with mild, hemodynamically insignificant defects. Instruments were returned by 83% of patients (25/30; 11 male; mean age, 44.6 ± 16 years). Health status by the linear analog scale was significantly lower (P=.03) in subjects (median, 80; range, 15-100) than in controls (median, 85; range, 65-100). Quality of life by the satisfaction with life scale was also lower (P=.009) in subjects (mean, 24 ± 8) compared with controls. Age was negatively correlated with the Short Form 36 Health Survey physical functioning (r=-0.41, P=.04), bodily pain (r=-0.5, P=.01), and physical component (r=-0.56, P=.004) summary scores in adults with congenitally corrected transposition but not in controls. Adults with congenitally corrected transposition have lower reported health status and satisfaction with life than a control population, with perceived health status declining with advancing age.

Sleep Duration and Mortality According to Health Status in Older Adults

To examine the association between usual sleep duration and mortality according to physical and mental health status in older adults. Prospective study conducted from 2001 to 2008. Community-based study. Cohort study of 3,820 persons representative of the noninstitutionalized population aged 60 and older in Spain. Sleep duration was self-reported at baseline. Analyses were performed using Cox regression and adjusted for the main confounders. The analyses were then stratified according to numerous indicators of health status. During follow-up, 897 persons died. Mortality was higher in those who slept 8 hours (relative risk (RR)=1.34, 95% confidence interval (CI)=1.02-1.76), 9 hours (RR 1.48, 95% CI=1.12-1.96), 10 hours (RR 1.73, 95% CI=1.30-2.29) and 11 hours or more (RR 1.66, 95% CI=1.23-2.24) than in those who slept 7 hours (P for trend <.001). The association between long sleep duration (≥10 vs 7 hours) and mortality was observed even in persons with good health status: optimal perceived health, good cognitive function (Mini-Mental State Examination score >27), no depression, quality of life better than the cohort median (Medical Outcomes Study 36-item Short Form Survey Physical Component Summary score ≥46 and Mental Component Summary score ≥52), and without disability in instrumental activities of daily living. Sleeping 6 hours or less was not associated with higher mortality than sleeping 7 hours in persons with good health status. Self-reported sleep duration was associated with 7-year mortality in this cohort of older adults, even when adjusted for health status. Further research is needed to determine the mechanisms and clinical implications of these findings.

Effect of a Zoster Vaccine on Herpes Zoster–Related Interference with Functional Status and Health‐Related Quality‐of‐Life Measures in Older Adults

To determine the efficacy of a zoster vaccine on herpes zoster (HR)-related interference with activities of daily living (ADLs) and health-related quality of life (HRQL). Randomized double-blind placebo controlled trial. Twenty-two U.S. sites. Thirty eight thousand five hundred forty-six women and men aged 60 and olcer. HZ burden of interference with ADLs and HRQL using ratings from the Zoster Brief Pain Inventory (ZBPI) and Medical Outcomes Study 12-item Short Form Survey (SF-12) mental component summary (MCS) and physical component summary (PCS) scores. Vaccine efficacy was calculated for the modified-intention-to-treat trial population and solely in participants who developed HZ. For the modified-intention-to-treat population, the overall zoster vaccine efficacy was 66% (95% confidence interval (CI)=55-74%) for ZBPI ADL burden of interference score and 55% (95% CI=48-61%) for both the SF-12 MCS and PCS scores. Of participants who developed HZ, zoster vaccine reduced the ZBPI ADL burden of interference score by 31% (95% CI=12-51%) and did not significantly reduce the effect on HRQL. Zoster vaccine reduced the burden of HZ-related interference with ADLs in the population of vaccinees and in vaccinees who developed HZ. Zoster vaccine reduced the effect of HZ on HRQL in the population of vaccinees but not in vaccinees who developed HZ.

The Italian version of the Lower Extremity Functional Scale was reliable, valid, and responsive

Objective To determine the measurement properties of an Italian Version of the Lower Extremity Functional Scale (LEFS) in patients with lower extremity musculoskeletal dysfunction. Study Design and Setting This is a prospective methodological study of repeated measures with a sample of 250 consecutive patients. Reliability, validity, and responsiveness were evaluated. Results The Italian version of the LEFS showed a high degree of internal consistency with a Cronbach alpha of 0.94 (95% confidence interval [CI]: 0.91, 0.96). The test–retest reliability was high for both intra-interviewer and inter-interviewer measures with an ICC (2,1 and 2,k) of 0.91 (95% CI: 0.86, 0.93) and 0.89 (95% CI: 0.83, 0.91), respectively. The LEFS showed a better correlation with the 36-Item Short-Form Health Survey (SF-36) physical component summary score rather than with the SF-36 mental component summary score both at the initial assessment ( r = 0.61 and 0.26, respectively) and at the discharge ( r = 0.72 and 0.22, respectively). Receiver operating characteristic curve analysis revealed a large responsiveness for the LEFS (area under the curve [AUC] = 0.97) and a moderate responsiveness for the SF-36 (AUC = 0.68). Conclusion The Italian version of the LEFS is a valid, reliable, and responsive tool that can be used to measure function in Italian patients with lower extremity musculoskeletal dysfunction.

The Effects of a Presurgical Stress Management Intervention for Men With Prostate Cancer Undergoing Radical Prostatectomy

PURPOSE This study assessed the short-term and long-term efficacy of a presurgical stress management intervention at reducing mood disturbance and improving quality of life (QOL) in men undergoing radical prostatectomy (RP) for prostate cancer. PATIENTS AND METHODS One hundred fifty-nine men were randomly assigned to a two-session (plus two boosters) presurgical stress management intervention (SM), a two-session (plus two boosters) supportive attention group (SA), or a standard care group (SC). Assessments occurred 1 month before surgery; 1 week before surgery; the morning of surgery; 6 weeks after surgery, and 6 and 12 months after surgery. Results Results indicated significant group differences in mood disturbance before surgery (P = .02), such that men in the SM group had significantly less mood disturbance than men in the SC group (P = .006), with no significant differences between the SM and SA or SA and SC groups. In the year after surgery, there were significant group differences on Medical Outcomes Study 36-item short form survey (SF-36) physical component summary (PCS) scores (P = .004); men in the SM group had significantly higher PCS scores than men in the SC group (P = .0009), and there were no significant differences between the SM and SA or SA and SC groups. There were no group effects on prostate-specific QOL or SF-36 mental health scores. CONCLUSION These findings demonstrate the efficacy of a brief presurgical stress management intervention in improving some short-term and long-term outcomes. If these results are replicated, it may be a useful adjunct to standard care for men with prostate cancer undergoing surgery.

Six-Year Outcomes of Anterior Lumbar Interbody Arthrodesis with Use of Interbody Fusion Cages and Recombinant Human Bone Morphogenetic Protein-2

Twenty-four-month outcomes have been reported for patients with degenerative lumbar disc disease who were treated with stand-alone anterior lumbar interbody arthrodesis with use of dual tapered interbody fusion cages and recombinant human bone morphogenetic protein-2. This report represents an update of the clinical and radiographic results of this treatment at six years. Two hundred and seventy-seven patients with single-level degenerative disc disease with up to grade-I spondylolisthesis were enrolled in two prospective, multicenter, U.S. Food and Drug Administration-approved investigational device exemption studies and were treated with an open or a laparoscopic surgical procedure. The patients received recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge with lumbar fusion cage implants. One hundred and forty-six patients completed the six-year clinical follow-up evaluations, and 130 patients had complete radiographic follow-up at six years. Outcomes were determined with use of well-established clinical outcome measurements (Oswestry Disability Index, Short Form-36, and back and leg pain scores) and radiographic assessments. At six years, 128 (98%) of the 130 patients treated with recombinant human bone morphogenetic protein-2 and stand-alone fusion cages had a fusion. The second surgery rate was 6.7% (eighteen patients) prior to two years and 3.7% (seven patients) from two to six years. A worst-case scenario analysis, which includes all second surgical procedures due to pseudarthrosis, resulted in a fusion rate at seventy-two months of 91% (128 of 141). Significant improvements in the Oswestry Disability Index scores, Short Form-36 health survey physical component summary scores, and back and leg pain scores were achieved by six weeks in both the open and laparoscopic groups and were sustained at six years (p < 0.001). The percentage of patients who were working at six months (63%) was higher than the percentage who had been working preoperatively (52%), and this improvement was sustained at six years (68%). The use of dual tapered threaded fusion cages and recombinant human bone morphogenetic protein-2 on an absorbable collagen sponge obtained and maintained intervertebral spinal fusion, improved clinical outcomes, and reduced pain after anterior lumbar interbody arthrodesis in patients with degenerative lumbar disc disease.

Impact of a Weight Management Program on Health-Related Quality of Life in Overweight Adults With Type 2 Diabetes

Inconsistent findings have been reported regarding improved health-related quality of life (HRQOL) after weight loss. We tested the efficacy of a weight management program for improving HRQOL in overweight or obese adults diagnosed as having type 2 diabetes mellitus. We conducted a randomized multisite clinical trial at 16 outpatient research centers with 2 treatment arms and blinded measurements at baseline and the end of year 1. A total of 5145 participants (mean [SD] age, 58.7 [6.9] years; mean [SD] body mass index [calculated as weight in kilograms divided by height in meters squared], 36.0 [5.9]; 59.5% women; 63.1% white) were randomized to an intensive lifestyle intervention (ILI) or to diabetes support and education (DSE). Main outcome measures included the 36-Item Short-Form Health Survey physical component summary (PCS) and mental health component summary (MCS) scores and Beck Depression Inventory II (BDI-II) scores. Baseline mean (SD) scores were 47.9 (7.9) for PCS, 54.0 (8.1) for MCS, and 5.7 (5.0) for BDI-II. Improved HRQOL was demonstrated by the PCS and BDI-II scores (P < .001) in the ILI arm compared with the DSE arm. The largest effect was observed for the PCS score (difference, -2.91; 99% confidence interval, -3.44 to -2.37). The greatest HRQOL improvement occurred in participants with the lowest baseline HRQOL levels. Mean (SD) changes in weight (ILI, -8.77 [8.2] kg and DSE, -0.86 [5.0] kg), improved fitness, and improved physical symptoms mediated treatment effects associated with the BDI-II and PCS. Overweight adults diagnosed as having type 2 diabetes experienced significant improvement in HRQOL by enrolling in a weight management program that yielded significant weight loss, improved physical fitness, and reduced physical symptoms. clinicaltrials.gov Identifier: NCT00017953.

Physical function, disease activity, and health-related quality-of-life outcomes after 3 years of adalimumab treatment in patients with ankylosing spondylitis

IntroductionWe evaluated the three-year impact of adalimumab on patient-reported physical function and health-related quality-of-life (HRQOL) outcomes in patients with active ankylosing spondylitis (AS).MethodsThe Adalimumab Trial Evaluating Long-Term Efficacy and Safety in AS (ATLAS) is an ongoing five-year study that included an initial 24-week, randomized, placebo-controlled, double-blind period, followed by open-label extension treatment with adalimumab. Clinical and HRQOL data collected for up to three years from ATLAS were used for these analyses. Patients were randomized to receive adalimumab 40 mg or placebo by subcutaneous injection every other week. Physical function was assessed by the Bath AS Functional Index (BASFI), as well as by the Short Form 36 (SF-36) Health Survey Physical Component Summary (PCS) and Physical Function subscale scores. HRQOL was assessed using the AS Quality of Life (ASQOL) questionnaire. Disease activity was assessed by the Bath AS Disease Activity Index (BASDAI).ResultsOf 315 patients enrolled in ATLAS, 288 (91%) participated in an open-label adalimumab treatment extension and 82% provided three-year outcome data. During the 24-week double-blind phase, adalimumab-treated patients experienced significant improvement compared with placebo-treated patients in the BASDAI (P < 0.001), BASFI (P < 0.001), ASQOL (P < 0.001), and both the SF-36 PCS (P < 0.001) and Physical Function subscale (P < 0.001) scores, but not the SF-36 Mental Component Summary score (P = 0.181) and Mental Health subscale scores (P = 0.551). Mean changes from baseline through three years of adalimumab treatment were statistically significant for the BASDAI (change score: -3.9, P < 0.001), BASFI (change score: -29.6, P < 0.001), SF-36 PCS (change score: 11.6, P < 0.001), and Physical Function (change score: 23.3, P < 0.001). Comparable results were observed for the other SF-36 scores and for the ASQOL (all P < 0.001).ConclusionsAdalimumab significantly improved disease activity, patient-reported physical function, and HRQOL. These benefits were maintained over three years of treatment in patients with AS.Trial registrationClinicalTrials.gov NCT00085644.

Clinical and radiographic analysis of cervical disc arthroplasty compared with allograft fusion: a randomized controlled clinical trial

The authors report the results of a prospective randomized multicenter study in which the results of cervical disc arthroplasty were compared with anterior cervical discectomy and fusion (ACDF) in patients treated for symptomatic single-level cervical degenerative disc disease (DDD). Five hundred forty-one patients with single-level cervical DDD and radiculopathy were enrolled at 32 sites and randomly assigned to one of two treatment groups: 276 patients in the investigational group underwent anterior cervical discectomy and decompression and arthroplasty with the PRESTIGE ST Cervical Disc System (Medtronic Sofamor Danek); 265 patients in the control group underwent decompressive ACDF. Eighty percent of the arthroplasty-treated patients (223 of 276) and 75% of the control patients (198 of 265) completed clinical and radiographic follow-up examinations at routine intervals for 2 years after surgery. Analysis of all currently available postoperative 12- and 24-month data indicated a two-point greater improvement in the neck disability index score in the investigational group than the control group. The arthroplasty group also had a statistically significant higher rate of neurological success (p = 0.005) as well as a lower rate of secondary revision surgeries (p = 0.0277) and supplemental fixation (p = 0.0031). The mean improvement in the 36-Item Short Form Health Survey Physical Component Summary scores was greater in the investigational group at 12 and 24 months, as was relief of neck pain. The patients in the investigational group returned to work 16 days sooner than those in the control group, and the rate of adjacent-segment reoperation was significantly lower in the investigational group as well (p = 0.0492, log-rank test). The cervical disc implant maintained segmental sagittal angular motion averaging more than 7 degrees. In the investigational group, there were no cases of implant failure or migration. The PRESTIGE ST Cervical Disc System maintained physiological segmental motion at 24 months after implantation and was associated with improved neurological success, improved clinical outcomes, and a reduced rate of secondary surgeries compared with ACDF.

The Effects of Infliximab Therapy on Health-Related Quality of Life in Ulcerative Colitis Patients

The impact of infliximab induction and maintenance therapy on health-related quality of life (HRQL) was evaluated in patients with ulcerative colitis (UC). In two placebo-controlled, double-blind studies (the Active Ulcerative Colitis Trials 1 and 2 [ACT 1 and 2]), 728 patients were randomized to placebo or infliximab 5 mg/kg or 10 mg/kg. Infusions were administered at weeks 0, 2, 6, and every 8 wk thereafter, up to week 22 (ACT 2) or 46 (ACT 1). Changes in Inflammatory Bowel Disease Questionnaire (IBDQ) and Medical Outcomes Study 36-Item Short Form Health Survey physical and mental component summary (PCS and MCS, respectively) scores were analyzed. Baseline scores for the pooled patient population indicated substantial impairment in HRQL. Improvement at week 8 in the total IBDQ score was significantly greater in the infliximab 5-mg/kg (40, P < 0.001) and 10-mg/kg (36, P < 0.001) groups compared with the placebo group (28). Improvement at week 8 was also significantly greater in the infliximab 5- and 10-mg/kg groups for the PCS (6.8 and 5.9, respectively) and MCS (5.9 and 6.4, respectively) compared with placebo (PCS = 3.7, MCS = 3.0, P < 0.01 for all comparisons). Continued benefit was seen at weeks 30 and 54 with infliximab maintenance therapy (P < 0.001 for all comparisons). Improvement in total IBDQ score correlated significantly (P < 0.001) with improvement in both PCS and MCS scores, and Mayo score. Infliximab therapy substantially improved HRQL in patients with UC. This benefit was sustained through 1 yr with maintenance infliximab therapy.

Correlation between generic health status and region-specific functional measures on patients with neck pain

This is a cross-sectional and prospective study to examine the correlation between the Northwick Park Neck Pain Questionnaire and the Medical Outcomes 36-Item Short-Form Health Survey on patients with neck pain in the course of physiotherapy. A total of 359 consecutive adult patients with neck pain, from three physiotherapy outpatient departments, who completed the Northwick Park Neck Pain Questionnaire and Medical Outcomes 36-Item Short-Form Health Survey, were observed and measured at different intervals - at the beginning of physiotherapy, at week 3, week 6 and upon discharge from physiotherapy. The results showed that both the Northwick Park Neck Pain Questionnaire and the Medical Outcomes 36-Item Short-Form Health Survey were able to differentiate patients with neck pain in health and diseased states. The Spearman's correlation coefficients between the Northwick Park Neck Pain Questionnaire and the 36-Item Short-Form Health Survey physical and mental component summary scores at entry of physiotherapy were -0.64 with the physical component summary score and -0.44 with the mental component summary score, and, at discharge from physiotherapy, were -0.75 with the physical component summary score and -0.46 with the mental component summary score. The Northwick Park Neck Pain Questionnaire has psychometric properties with both physical and mental dimensions of measurement of pain in patients with neck pain.

A 2-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, phase III trial comparing the efficacy of oxymorphone extended release and placebo in adults with pain associated with osteoarthritis of the hip or knee

Background: Oxymorphone extended release (ER) is a tablet formulation of the μ-opioid agonist oxymorphone designed to achieve a low peak-to-trough fluctuation in plasma concentrations over a 12-hour dosing period. Objective: This study compared the analgesic efficacy, dose response, and tolerability of 3 doses of oxymorphone ER given every 12 hours with those of placebo in patients with pain related to osteoarthritis (OA) of the hip or knee. Methods: This was a 2-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, Phase III trial. Patients with OA of the hip or knee who were receiving an opioid medication for chronic, moderate to severe pain or who were judged by the investigator to have received suboptimal analgesia with nonopioid analgesics entered a 2- to 7-day washout of analgesic medication. When pain in the index joint was >40 mm on a 100-mm visual analog scale (VAS), patients were randomized to receive 1 of 4 regimens: oxymorphone ER 10 mg q12h during weeks 1 and 2; oxymorphone ER 20 mg q12h in week 1 and 40 mg q12h in week 2; oxymorphone ER 20 mg q12h in week 1 and 50 mg q12h in week 2; or placebo q12h during weeks 1 and 2. The primary end point was the change in VAS score for arthritis pain intensity. Other assessments included the Western Ontario and McMaster Universities (WOMAC) OA Index subscales for pain, stiffness, and physical function and the composite index; the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) physical health component summary (PCS) score; the Chronic Pain Sleep Inventory (CPSI) score; vital signs; clinical laboratory parameters; and adverse events (AEs). AEs were recorded at each clinic visit. Results: Three hundred seventy patients were randomizedto treatment (95 oxymorphone ER 10 mg, 93 oxymorphone ER 40 mg, 91 oxymorphone ER 50 mg, and 91 placebo), and 198 completed the study. Least squares mean changes from baseline in the VAS arthritis pain intensity score were −21, −28, −29, and −17 mm in the oxymorphone ER 10, 40, and 50 mg and placebo groups, respectively ( P = 0.002, modified Tukey linear trend test). Oxymorphone ER 40 and 50 mg produced significant improvements from baseline compared with placebo in the WOMAC subscale scores for pain (least squares mean change: −85.1, −108.0, and −42.5, respectively; P ≤ 0.025 for 40 mg, P ≤ 0.001 for 50 mg), stiffness (−40.5, −48.1, and −17.0; both, P ≤ 0.001), and physical function (−256.8, −310.8, and −116.5; P ≤ 0.01 and P ≤ 0.001, respectively); the SF-36 PCS score (4.6, 3.6, and −0.1; P < 0.001); and the CPSI score (−21.2, −22.2, and −10.7; P < 0.05). The 10-mg dose also was associated with significant improvements compared with placebo in the WOMAC pain (−83.6; P ≤ 0.025) and physical function subscales (−232.9; P ≤ 0.025) and the SF-36 PCS score (3.9; P < 0.001). The most frequently reported AEs (≥5% of patients) in the oxymorphone ER groups were nausea (39.4%), vomiting (23.7%), dizziness (22.6%), constipation (22.2%), somnolence (17.6%), pruritus (16.5%), and headache (15.0%). The majority of AEs with oxymorphone ER were mild or moderate in intensity. Three serious AEs (urinary retention, central nervous system depression, and pancreatitis) were considered possibly or probably related to study medication. Conclusion: In these patients with chronic, moderate to severe pain related to OA of the hip or knee, oxymorphone ER administered twice daily for 2 weeks produced dose-related reductions in arthritis pain intensity and improvements in physical function.

Prospective Evaluation of Health-Related Quality of Life in Patients With Deep Venous Thrombosis

To our knowledge, the burden of deep venous thrombosis from the patient's perspective has not been quantified. We evaluated health-related quality of life (QOL) after deep vein thrombosis and compared results with general population norms. This was a multicenter prospective cohort study of 359 consecutive eligible patients with deep vein thrombosis recruited at 7 Canadian hospital centers. Quality of life was assessed at baseline and at 1 and 4 months after diagnosis using generic (36-Item Short-Form Health Survey) and disease-specific (Venous Insufficiency Epidemiological and Economic Study [VEINES]-QOL and VEINES symptom [VEINES-Sym] questionnaires) measures. Changes in QOL scores during the 4-month period were calculated, and determinants of lack of improvement in QOL were evaluated. During the 4 months, mean 36-Item Short-Form Health Survey physical and mental component summary scores improved by 5.1 and 4.6 points, respectively, and VEINES-QOL and VEINES-Sym scores improved by 3.1 and 2.2 points, respectively (P < .001 for time trend for all measures). However, about one third of patients had worsening of QOL during follow-up. Multivariate analyses showed that worsening of the postthrombotic syndrome score was an independent predictor of worsening of 36-Item Short-Form Health Survey physical component summary (P = .04), VEINES-QOL (P < .001), and VEINES-Sym (P < .001) scores. The 36-Item Short-Form Health Survey physical component summary scores were lower than population norms at all points assessed. On average, QOL improves during the 4 months following deep vein thrombosis. However, in about one third of patients, QOL deteriorates, and at 4 months, average QOL remains poorer than population norms. Worsening of the postthrombotic syndrome score is associated with worsening of QOL.

Impact of depressive symptoms on adult asthma outcomes

Psychological disorders, including depression, are common in adults with asthma. Although depression is treatable, its impact on longitudinal asthma outcomes is not clear. To elucidate the impact of depressive symptoms on patient-centered outcomes and emergency health care use in adults with asthma. We conducted a prospective cohort study of 743 adults with asthma who were recruited after hospitalization for asthma. Depressive symptoms were defined as having a score of 16 or more on the Center for Epidemiologic Studies Depression Scale. We examined the impact of depressive symptoms on patient-centered outcomes (validated severity-of-asthma score, Marks Asthma Quality of Life Questionnaire, and 12-Item Short-Form Health Survey physical component summary score) and on future emergency health care use for asthma ascertained from computerized databases. The prevalence of depressive symptoms was 18% (95% confidence interval [CI], 15%-21%) among adults with asthma. Depressive symptoms were associated with greater severity-of-asthma scores after controlling for age, sex, race/ ethnicity, educational attainment, and cigarette smoking (mean score increment, 2.6 points; 95% CI, 1.8-3.4 points). Furthermore, depressive symptoms were associated with poorer asthma-specific quality of life (mean score increment, 19.9 points; 95% CI, 17.7-22.1 points) and poorer physical health status (mean score decrement, 3.7 points; 95% CI, 1.5-5.8 points). Depressive symptoms were associated with a greater longitudinal risk of hospitalization for asthma (hazard ratio, 1.34; 95% CI, 0.98-1.84). After controlling for differences in preventive care for asthma, the relationship was stronger (hazard ratio, 1.45; 95% CI, 1.05-2.0). Depressive symptoms are common in adults with asthma and are associated with poorer health outcomes, including greater asthma severity and risk of hospitalization for asthma.

Effects of hemodialysis dose and membrane flux on health-related quality of life in the HEMO Study

It has been widely supposed that high dose and high flux hemodialysis would affect the quality as well as the length of life of patients treated by maintenance hemodialysis. The HEMO Study examined changes in health-related quality of life as a secondary study outcome. Specific hypotheses were that study interventions would affect physical functioning, vitality, Short Form-36 Health Survey (SF-36) physical and mental component summary scores, symptoms and problems associated with kidney disease, and sleep quality. At baseline and annually, subjects responded to both the Index of Well-Being and the Kidney Disease Quality of Life-Long Form questionnaires. The interventions were assessed on the basis of their average effects over 3 years. At baseline, the SF-36 physical component summary score was lower than in healthy populations, but the mental component score was nearly normal. Over 3-year follow-up, physical health continued to decline; mental health and kidney disease-targeted scores remained relatively stable. The high dose hemodialysis intervention was associated with significantly less pain (4.49 points, P < 0.001) and higher physical component scores (1.23 points P= 0.007), but these effects were small compared to the natural variability in scores. High flux membranes were not associated with statistically significant differences in health-related quality of life. The HEMO Study results demonstrate the marked burden of chronic kidney failure and hemodialysis treatment on daily life. In this trial among patients undergoing maintenance three times a week hemodialysis, the SF-36 physical component summary score and pain scale showed significant but very small clinical effects favoring the higher dialysis dose. No clinically meaningful benefits or either the dose or flux interventions were observed for other indices of health-related quality of life.

The association between mental health, physical function, and hemodialysis mortality

Mortality rates for individuals on chronic hemodialysis remain very high; therefore, strategies are needed to identify individuals at greatest risk for mortality so preventive strategies can be implemented. One such approach is to stratify individuals by self-reported mental health and physical function. Examining these parameters at baseline, and over time, may help identify individuals at greater risk for mortality. We enrolled 14,815 individuals with end-stage renal disease (ESRD) and followed these individuals for up to 2 years. The mean age was 61.0 +/- 15.4 years (range, 20 to 96 years) and 31% were African Americans. The SF-36 Health Survey was administered 1 to 3 months after hemodialysis initiation and 6 months later. We examined the associations between the initial SF-36 Health Survey mental component summary (MCS) and physical component summary (PCS) scores and mortality during the follow-up period, and examined the associations between 6-month decline in PCS and MCS scores and subsequent mortality. We also examined the interactions between age and MCS and PCS scores. The general population-based mean of each of these scores was 50 with a standard deviation of 10. The main outcome measurement was death. Self-reported baseline mental health (MCS score) and physical function (PCS score) were both independently associated with increased mortality, and 6-month decline in these parameters was also associated with increased mortality. The multivariate hazard ratios for 1-year mortality for MCS scores of less than 30, 30 to 39, and 40 to 49 were 1.48 (95% CI, 1.32 to 1.64), 1.23 (95% CI, 1.14 to 1.32) and 1.18 (95% CI, 1.10 to 1.26) compared with a MCS score of 50 or more. The hazard ratios for PCS scores of less than 20, 20 to 29, and 30 to 39 were 1.97 (95% CI, 1.64 to 2.36), 1.62 (95% CI, 1.36 to 1.92), and 1.32 (95% CI, 1.11 to 1.57) compared with a PCS score of 50 or more. Six-month decline in self-reported mental health (hazard ratio, 1.07; 95% CI, 1.02 to 1.12, per 10-point decline in MCS score) and physical function (hazard ratio, 1.25; 95% CI, 1.18 to 1.33, per 10-point decline in PCS score) were also both significantly associated with an additional increase in mortality beyond baseline risk. We also found a significant interaction between age and physical function (P = 0.02). Specifically, there was a graded response between the PCS score category and mortality in most age strata, but this relationship was not observed in the oldest age (85 years old or older). In individuals newly initiated on chronic hemodialysis, self-reported baseline mental health and physical function are important, independent predictors of mortality, and there is a graded relationship between these parameters and mortality risk. Following these parameters over time provides additional information on mortality risk. One must also consider age when interpreting the relationship between physical function and mortality.