Changes In Health-related Quality Of Life Scores Research Articles

Evaluation of Health-Related Quality of Life Associated with Provision of Healthcare to Stroke Patients Living at Home in Japan

Objective: As stroke mortality rates decline in Japan, a large proportion of disabled stroke survivors living in their homes are supported by informal caregivers or formal healthcare services. To evaluate the impact of healthcare provision on outcome of stroke patients living at home, this study investigated the associations of long-term care and health-related quality of life (HRQOL) in patients 1 year after stroke onset. Methods: Data on patient and caregiver characteristics, HRQOL of patients, and healthcare services for those living at home were prospectively collected from 426 patients with stroke at baseline and 12 months. Using general measures of HRQOL, namely, Short Form-36 (SF-36) and EuroQOL 5 dimension (EQ-5D), multivariate regression models were used to determine the contribution of variables to changes in HRQOL scores from discharge to the first year after stroke. Results: Five domains of SF-36—role-physical, vitality, social functioning, role- emotional, and mental health—were significantly improved 1 year after stroke. Factors affecting changes in the five domains of HRQOL were age, independence in activities of daily living, and cognitive function. Home care service was positively associated with role-physical, social functioning, and role-emotional. In addition, home rehabilitation and home bathing services were positively associated with social functioning. Conclusion: This study clarified that improvements of HRQOL 1 year after stroke were associated with use of home-based services involving home care service, home rehabilitation, and home bathing services. The use of home-based services contributed to the improved welfare of patients living at home.

Does change in health-related quality of life score predict survival? Analysis of EORTC 08975 lung cancer trial.

Background:Little is known about whether changes in health-related quality of life (HRQoL) scores from baseline during treatment also predict survival, which we aim to investigate in this study.Methods:We analysed data from 391 advanced non-small-cell lung cancer (NSCLC) patients enrolled in the EORTC 08975 study, which compared palliative chemotherapy regimens. HRQoL was assessed at baseline and after each chemotherapy cycle using the EORTC QLQ-C30 and QLQ-LC13. The prognostic significance of HRQoL scores at baseline and their changes over time was assessed with Cox regression, after adjusting for clinical and socio-demographic variables.Results:After controlling for covariates, every 10-point increase in baseline pain and dysphagia was associated with 11% and 12% increased risk of death with hazard ratios (HRs) of 1.11 and 1.12, respectively. Every 10-point improvement of physical function at baseline (HR=0.93) was associated with 7% lower risk of death. Every 10-point increase in pain (HR=1.08) was associated with 8% increased risk of death at cycle 1. Every 10-point increase in social function (HR=0.91) at cycle 2 was associated with 9% lower risk of death.Conclusions:Our findings suggest that changes in HRQoL scores from baseline during treatment, as measured on subscales of the EORTC QLQ-C30 and QLQ-LC13, are significant prognostic factors for survival.

Changes in health-related quality of life (HRQL) after bladder cancer (BC) diagnosis (DX): A longitudinal population-based study.

317 Background: Few studies have examined longitudinal changes in HRQL among BC patients. To our knowledge, this is the largest prospective population-based study to quantify HRQL changes from before to after BC DX and to compare their HRQL with a non-cancer cohort. Methods: Our sample included 179 BC patients (≥ age 65) and 376,986 non-cancer subjects within the SEER-Medicare Health Outcomes Survey database (1998-2007). We assessed HRQL as measured by physical (PCS) and mental (MCS) component summary scores of the veterans RAND 12-item health survey. An analysis of covariance model was used to estimate changes in HRQL scores for patients after BC DX relative to control subjects with adjustment for baseline HRQL scores and covariates. Results: 84.4% (N=151) of BC patients had non-muscle invasive BC (NMIBC) and 15.6% (N=28) had muscle invasive BC (MIBC). 49.2% and 39.1% of BC patients had ≥2 comorbid conditions and ≥1 activities of daily living (ADL) deficit, respectively. Compared to the control subjects, more BC patients were men (67.0% vs 38.5%; P<0.01), current or former smokers (58.7% vs 37.3%; P<0.01), and had income ≥ $50,000(15.1% vs 8.8%; P=0.02). Other baseline demographic and socioeconomic characteristics were similar (P>0.05). After DX, BC patients reported a significant decline in PCS (1.9; 95% CI 0.1, 3.7) score compared to non-cancer controls whereas the decrease in MCS score (1.4; 95% CI -0.1, 3.0) was not statistically significant. For those with NMIBC, HRQL was not significantly different than that of the non-cancer cohort (P>0.05) after DX. However, the PCS and MCS scores of MIBC patients decreased by 5.3 (95% CI 0.9, 9.8) and 3.8 points (95% CI -0.1, 7.7) after DX, respectively. Older age at BC DX, lower educational and income levels, smoking history, and higher numbers of comorbid conditions and ADL deficits were significantly associated with inferior PCS and MCS scores after BC DX (P<0.01). Conclusions: Treatment-related side effects and/or symptoms due to BC adversely affect HRQL of BC patients, especially in those with MIBC, and should be consistently assessed by health care providers. Future research that examines interventions to improve HRQL is critical to improve BC care.

The longitudinal association between weight change and health-related quality of life: the KORA S4/F4 cohort study

Despite the increasing importance of patient-centered perspectives, the impact of weight change on the health-related quality of life (HRQL) has remained unclear. This work aims to investigate this longitudinal relationship. Data was collected from a population-based cohort study of 3,080 Germans. Anthropometrics and HRQL were assessed at baseline and after a 7-year follow-up period. Using linear regression the average change in HRQL scores was calculated among 5 mutually exclusive weight change groups. Multilevel growth modeling was conducted to differentiate between interpersonal (cross-sectional) and intrapersonal (longitudinal) associations between body mass index (BMI)/BMI change and HRQL. Heavy weight gain (≥10 % body weight) was associated with impairments in physical health among women (-2.82 points, CI: -4.29, -1.34) and obese men (-4.33 points, CI: -7.62, -1.04) and with improvements in mental health among women (+3.20 points, CI: +1.37, +5.02). Results from the multilevel models were consistent, showing negative associations between BMI change and physical health, positive associations between BMI change and mental health and a high degree of similarity between interpersonal and intrapersonal associations. Weight gain leads to clinically relevant impairments in physical health. More research is needed to clarify the antipodal effects of weight change on physical and mental health components.

A Comprehensive Symptom Diary Intervention to Improve Outcomes in Patients With HF: A Pilot Study

BackgroundPatients with heart failure must monitor for and recognize escalating symptoms to take action to relieve symptoms and decrease hospitalizations. However, symptom monitoring is not commonly performed. One way to promote patients’ engagement in symptom monitoring is by providing a symptom diary. PurposeThe aim of this study was to test the effect of a comprehensive daily symptom diary intervention on event-free survival and health-related quality of life (HRQOL). MethodsPatients were randomized into either intervention (n = 23) or usual-care groups (n = 21). The intervention group received a symptom diary with self-care education and counseling at baseline with 5 follow-up calls for 3 months. All patients were interviewed to obtain survival data at 1 month and 3 months. HRQOL was measured at baseline, 1 month, and 3 months. Kaplan-Meier curves with the log-rank test were used to compare group differences in time to first event. Linear mixed models were conducted to examine the relationship between groups and changes in HRQOL over 3 months. ResultsThe intervention group had longer event-free survival than the usual-care group (P = .03). There were no differences in changes in HRQOL scores between the groups over 3 months. ConclusionsPositive effects of the intervention on survival were found. However, there was no significant difference in changes in HRQOL.

Changes in self-reported and parent-reported health-related quality of life in overweight children and adolescents participating in an outpatient training: findings from a 12-month follow-up study

BackgroundHealth-related quality of life (HRQoL) was found to improve in participants of weight management interventions. However, information on moderately overweight youth as well as on maintaining HRQoL improvements following treatment is sparse. We studied the HRQoL of 74 overweight, but not obese participants (32.4% male, mean age = 11.61 ± 1.70 SD) of a comprehensive and effective six-month outpatient training at four time-points up to 12 months after end of treatment.MethodsHRQoL was measured by self-report and proxy-report versions of the generic German KINDL-R, including six sub domains, and an obesity-specific additional module. Changes in original and z-standardized scores were analyzed by (2×4) doubly multivariate analysis of variance. This was done separately for self- and proxy-reported HRQoL, taking into account further socio-demographic background variables and social desirability. Additionally, correlations between changes in HRQoL scores and changes in zBMI were examined.ResultsThere were significant multivariate time effects for self-reported and proxy-reported HRQoL and a significant time-gender interaction in self-reports revealed (p < .05). Improvements in weight-specific HRQoL were evident during treatment (partial η2 = 0.14-0.19). Generic HRQoL further increased after end of treatment. The largest effects were found on the dimension self-esteem (partial η2 = 0.08-0.09 for proxy- and self-reported z-scores, respectively). Correlations with changes in weight were gender-specific, and weight reduction was only associated with HRQoL improvements in girls.ConclusionsPositive effects of outpatient training on generic and weight-specific HRQoL of moderately overweight (not obese) children and adolescents could be demonstrated. Improvements in HRQoL were not consistently bound to weight reduction. While changes in weight-specific HRQoL were more immediate, generic HRQoL further increased after treatment ended. An extended follow-up may therefore be needed to scrutinize HRQoL improvements due to weight management.Trial registrationclinicaltrials.gov NCT00422916

Quality of life in children with new-onset epilepsy

To assess health-related quality of life (HRQL) over 2 years in children 4-12 years old with new-onset epilepsy and risk factors. Data are from a multicenter prospective cohort study, the Health-Related Quality of Life Study in Children with Epilepsy Study (HERQULES). Parents reported on children's HRQL and family factors and neurologists on clinical characteristics 4 times. Mean subscale and summary scores were computed for HRQL. Individual growth curve models identified trajectories of change in HRQL scores. Multiple regression identified baseline risk factors for HRQL 2 years later. A total of 374 (82) questionnaires were returned postdiagnosis and 283 (62%) of eligible parents completed all 4. Growth rates for HRQL summary scores were most rapid during the first 6 months and then stabilized. About one-half experienced clinically meaningful improvements in HRQL, one-third maintained their same level, and one-fifth declined. Compared with the general population, at 2 years our sample scored significantly lower on one-third of CHQ subscales and the psychosocial summary. After controlling for baseline HRQL, cognitive problems, poor family functioning, and high family demands were risk factors for poor HRQL 2 years later. On average, HRQL was relatively good but with highly variable individual trajectories. At least one-half did not experience clinically meaningful improvements or declined over 2 years. Cognitive problems were the strongest risk factor for compromised HRQL 2 years after diagnosis and may be largely responsible for declines in the HRQL of children newly diagnosed with epilepsy.

Does change in health-related quality of life (HRQoL) score predict survival? Analysis of a lung cancer RCT.

7607 Background: Over 60 cancer clinical trials have shown that baseline health-related quality of life (HRQoL) scores are prognostic for patient survival. Few studies have investigated the added value of change in HRQoL scores. Our aim was to investigate if change in HRQoL scores from baseline over time is also associated with survival. Methods: We analyzed data from an EORTC 3-arm randomized clinical trial (RCT) in advanced non-small-cell lung cancer (NSCLC) patients, comparing gemcitabine+cisplatin, versus paclitaxel+gemcitabine, versus standard arm paclitaxel+cisplatin. HRQoL was measured in 394 patients using the EORTC QLQ-C30 at baseline and after each chemotherapy cycle. The prognostic significance of sex, age and WHO performance status (0-1 vs. 2) and the 15 QLQ-C30 subscales were assessed with Cox proportional hazard models stratified for treatment (level of significance 0.05). Changes in HRQoL scores from baseline to each chemotherapy cycle assessment were categorized as “improved”, “stable” and “worsened” using a threshold of 10 points difference. Due to expected attrition, the analysis was limited to changes from baseline up to cycle 3. Results: There were 248 patients in cycle 1, 212 in cycle 2 and 196 in cycle 3. We performed analyses separately using data at cycle 1, cycle 2, and cycle 3. In all analyses, HRQoL in various subscales and socio-demographic and clinical variables (physical functioning (hazard ratio [HR] 0.91, 95% CI 0.85-0.98; p=0.0103), pain (1.11, 1.05-1.17; p= 0.0004), age (0.98, 0.97-1.00, p=0.0413) and WHO performance status (1.77, 1.09-2.89; p=0.0218) at cycle 1; pain (1.11, 1.03-1.20; p=0.0016), age (0.98, 0.96-1.00; p=0.0217) and sex (0.63, 0.42-0.95; p=0.0081) at cycle 2; and role functioning (0.93, 0.88-1.00; p=0.0128) and age (0.98, 0.96-1.00; p=0.0081) at cycle 3) predicted survival; however, change in HRQoL was only an independent predictor for improvement at cycle 1. Conclusions: Our findings suggest that change from baseline over time in HRQoL, as measured on subscales of the EORTC QLQ-C30, contains added prognostic value for survival independent of baseline HRQoL scores. Further work is needed to assess the robustness and sensitivity of these findings.

Comparing Outcome Criteria Performance in Adult Strabismus Surgery

To evaluate the performance of motor, diplopia, and health-related quality of life (HRQOL) criteria when analyzing outcomes of adult strabismus surgery. Cohort study. We studied 159 adults undergoing 171 strabismus surgeries. All patients underwent clinical assessment preoperatively and 6 weeks postoperatively, including completion of Adult Strabismus-20 HRQOL questionnaires. Preoperatively, strabismus was classified as either diplopic (n = 117), nondiplopic (n = 38), or atypical diplopic (n = 16). To assess performance of motor, diplopia, and HRQOL criteria, success was defined a priori and applied separately and in combinations. For success: (1) motor criteria, <10 prism diopters by simultaneous prism cover test; (2) diplopia criteria, none or only rare in primary distance and for reading; (3) HRQOL criteria, exceeding previously reported 95% limits of agreement (LOA). Surgical success rate when applying motor, diplopia, and HRQOL criteria alone and in combinations. Overall, success rates were 90% for motor criteria, 74% for diplopia criteria, and 60% for HRQOL criteria. Combining criteria, the highest success rate was for motor plus diplopia criteria (67%) and the lowest success rate was when combining motor, diplopia, and HRQOL criteria (50%). Applying motor criteria alone yields the highest success rates when evaluating outcomes in adult strabismus surgery, but motor criteria do not fully represent the patient's postoperative status. Combining diplopia criteria with motor criteria provides a more clinically relevant standard for judging the success of adult strabismus surgery. For HRQOL criteria, exceeding 95% LOA at 6 weeks postoperatively seems to be a difficult hurdle to clear for some individual patients, and evaluating change in HRQOL score may be more useful in cohort studies.

Impact of response shift on longitudinal quality-of-life assessment in cancer clinical trials

The assessment of longitudinal change in subjective patient-reported outcomes such as health-related quality of life (HRQoL) is a key component of many clinical and research evaluations. A major goal of measuring patient-reported HRQoL is to determine to what extent changes in HRQoL reports over time represent true changes in HRQoL due to treatment or cancer and to what extent they reflect measurement error. Indeed, the subjective assessment of HRQoL change is subject to response-shift effects, whereby health changes lead to shifts in internal standards (i.e., ‘recalibration’), values (i.e., ‘reprioritization’) and conceptualization (i.e., ’reconceptualization’) of key HRQoL domains. Response shift is a naturally occurring process that could distort the interpretation of change in HRQoL scores over time in interventional studies. Assessing response shift may therefore be needed to obtain a valid and sensitive assessment of change over time. Several methods to detect and measure the size and the direction of response shift are available. In this article, we summarize the methods used to assess and adjust for the response-shift effect in clinical trials. Nevertheless, our understanding of the parameters and processes associated with response shift is very limited. Further research is still needed to better understand how to measure the different components of response shift and how to take them into account in cancer research.

Minimal clinically meaningful differences for the EORTC QLQ-C30 and EORTC QLQ-BN20 scales in brain cancer patients

BackgroundWe aimed to determine the smallest changes in health-related quality of life (HRQoL) scores in the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 and the Brain Cancer Module (QLQ-BN20), which could be considered as clinically meaningful in brain cancer patients. Materials and methodsWorld Health Organisation performance status (PS) and mini-mental state examination (MMSE) were used as clinical anchors appropriate to related subscales to determine the minimal clinically important differences (MCIDs) in HRQoL change scores (range 0–100) in the QLQ-C30 and QLQ-BN20. A threshold of 0.2 standard deviation (SD) (small effect) was used to exclude anchor-based MCID estimates considered too small to inform interpretation. ResultsBased on PS, our findings support the following integer estimates of the MCID for improvement and deterioration, respectively: physical (6, 9), role (14, 12), and cognitive functioning (8, 8); global health status (7, 4*), fatigue (12, 9), and motor dysfunction (4*, 5). Anchoring with MMSE, cognitive functioning MCID estimates for improvement and deterioration were (11, 2*) and for communication deficit were (9, 7). Estimates with asterisks were <0.2 SD and were excluded from our MCID range of 5–14. ConclusionThese estimates can help clinicians evaluate changes in HRQoL over time, assess the value of a health care intervention and can be useful in determining sample sizes in designing future clinical trials.

Cardiac Surgery in Octogenarians Results in Subjective Gains but No Objective Improvements in Quality of Life or Functional Status after three Months

Objective: To determine health related quality of life (HRQoL), functional status and re-admissions in patients 80 years and older three months after cardiac surgery Methods: Pilot prospective cohort study. Primary outcome measure: Change in HRQoL scores between baseline and three months following cardiac surgery Results: Sixty-three cardiac surgery patients were enrolled. The most frequent surgical procedures were CABG in 27 (43%), CABG + AVR/MVR in 18 (29%), AVR/MVR in 16 (25%). 61 (97%) were elective. Mean (SD) age was 83.2 (2.5) years, 56% were men, and mean (SD) length of hospital stay was 13.4 (5.9) days. Baseline self-reported co-morbidities included hypertension in 39 (62%), osteoarthritis in 27 (43%) and back pain in 21 (33%). and prosthetic heart valves with a significant risk of complications if treatment is delayed. Method: A retrospective analysis of 191 patients revealed nine patients who underwent valve replacement at The Townsville Hospital from 2008 until March 2011 with acute infective endocarditis. The outcome measures were native/prosthetic valve, indication for surgery, timing to surgery, and necessity for pre-surgical coronary angiogram. Results: A total of nine patients underwent valve replacement for active infective endocarditis. The average time to surgery fromonset of symptomswas 21.8 dayswith seven patients presenting to a peripheral centre. Themost common complication prior to surgical intervention was septic emboli (55%) followedbyheart failure (44%).Native valve endocarditis occurred in 66% of cases and surgery was performed on average 23.6.days after the onset of symptoms. Prosthetic valve endocarditiswas found in 33% and surgery was performed on an average of 18.3 days. None of the patients underwent cardiac catheterisation prior to surgery. One patients died following re-do valve surgery. Conclusion: Infective endocarditis requiring surgical managementwasmore common innative valveswith time to diagnosis being longer, compared to prosthetic valve endocarditis. Barriers to early surgery included late presentation to hospital and the need for transfer to a tertiary

Minimal important differences for interpreting health-related quality of life scores from the EORTC QLQ-C30 in lung cancer patients participating in randomized controlled trials

The aim of this study was to determine the smallest changes in health-related quality of life (HRQOL) scores in a subset of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire core 30 (EORTC QLQ-C30) scales, which could be considered as clinically meaningful in patients with non-small-cell lung cancer (NSCLC). WHO performance status (PS) and weight change were used as clinical anchors to determine minimal important differences (MIDs) in HRQOL change scores (range, 0-100) in the EORTC QLQ-C30 scales. Selected distribution-based methods were used for comparison. In a pooled dataset of 812 NSCLC patients undergoing treatment, the values determined to represent the MID depended on whether patients were improving or deteriorating. MID estimates for improvement (based on a one-category change in PS, 5 - <20% weight gain) were physical functioning (9, 5); role functioning (14, 7); social functioning (5, 7); global health status (9, 4); fatigue (14, 5); and pain (16, 2). The respective MID estimates for deterioration (based on PS, weight loss) were physical (4, 6); role (5, 5); social (7, 9); global health status (4, 4); fatigue (6, 11); and pain (3, 7). Based on the selected QLQ-C30 scales, the MID may depend upon whether the patients' PS is improving or worsening, but our results are not definitive. The MID estimates for the specified scales can help clinicians and researchers evaluate the significance of changes in HRQOL and assess the value of a health care intervention or compare treatments. The estimates also can be useful in determining sample sizes in the design of future clinical trials.

Longitudinal Changes in Visual Acuity and Health-related Quality of Life: The Los Angeles Latino Eye Study

To examine the association between longitudinal changes in visual acuity (VA) and health-related quality of life (HRQOL) in a population-based sample of adult Latinos. A population-based cohort study of eye disease in Latinos. We included 3169 adult Latino participants who live in the city of La Puente, California. Data for these analyses were collected for the Los Angeles Latino Eye Study (LALES). Distance VA was measured during a detailed ophthalmologic examination using the standard Early Treatment Diabetic Retinopathy Study protocol at baseline and a 4-year follow-up examination. We assessed HRQOL by the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and the Medical Outcomes Study 12-Item Short-Form Health Survey version 1 (SF-12). Mean differences in HRQOL composite and subscale scores between baseline and follow-up were calculated for 3169 participants with complete clinical examination and HRQOL data at both time points. Mean differences and effect sizes (ES) for NEI-VFQ and SF-12 scores were calculated for 3 categories of VA change over the 4-year follow-up period (VA improved ≥ 2 lines, no change in VA or -2 < VA < 2, VA loss ≥ 2 lines). For participants with a 2-line loss in VA, we noted an approximate 5-point loss in the NEI-VFQ-25 composite score, with the greatest score changes found for the driving difficulties, vision-related mental health, and vision-related dependency subscales (-12.7, -11.5, and -11.3, respectively). For participants with a 2-line improvement in VA, we also noted an approximate 5-point gain in the NEI-VFQ-25 composite score. The greatest change (ES = 0.80) was observed for the driving difficulties subscale. No measurable differences in HRQOL were observed for individuals without change in VA from baseline to follow-up. Clinically important, longitudinal changes in VA (≥ 2-line changes) were associated with significant changes in self-reported visual function and well-being. Both the size and direction of VA change influenced change in HRQOL scores.

Changes in Health-Related Quality of Life among African-Americans in a lifestyle weight loss program

Changes in health-related quality of life (HRQoL) were assessed in clinically obese, African-American adults after completion of a weight loss program that resulted in modest average weight loss. Data were analyzed for 87 men and women who provided weight measurements after an initial 10-week weight loss program (Phase 1) and a subsequent clinical trial to evaluate three weight maintenance approaches (Phase 2) over an additional 8 to 18 months. HRQoL was assessed using the Short Form SF-36 questionnaire. Intra-person changes in HRQoL were assessed and analyzed for associations with weight change within each phase. Non-parametric bivariable analyses and multivariable linear regression were used in statistical analyses. Changes in HRQoL were modest; clinically significant intra-subject improvements in SF-36 domains of general health and vitality and in the mental component summary score were observed after Phase 1 but were attenuated during Phase 2. Improvements in vitality were significantly associated with greater weight loss in Phase 1, but no HRQoL change scores during Phase 2 were associated with weight change. Short-term improvements in general health and vitality were observed. The vitality domain of the SF-36 appeared to be the domain of HRQoL most responsive to modest weight change.

Prognostic Value of Changes in Health-Related Quality of Life Scores During Curative Treatment for Esophagogastric Cancer

Accumulating evidence suggests that health-related quality of life (HRQL) data before treatment predict survival, but the prognostic value of changes in HRQL scores after treatment is unknown. The aim of this study was to explore whether changes in HRQL scores in esophagogastric cancer predict survival. Consecutive patients undergoing curative treatment completed HRQL questionnaires (EORTC QLQ-C30) at baseline and after six months and were followed up for at least five years. Cox proportional hazard models with adjustments assessed associations between baseline HRQL and survival and between changes in HRQL before and after treatment and survival. Overall, 216 patients initiated curative therapy, of whom 169 completed treatment and survived 6 months. Of these, 132 (7%) had two complete HRQL assessments. Analyses adjusted for age, sex, performance status, tumor stage, and disease site revealed that a 10-point poorer dyspnea score at baseline was significantly associated with an 18% higher risk of death. Additional analyses to adjust for baseline HRQL and treatment showed that a 10-point change in physical function (hazard ratio [HR], 0.85; 95% CI, 0.76 to 0.96; P = .007), pain (HR, 1.20; 95% CI, 1.09 to 1.33; P < .001), and fatigue (HR, 1.16; 95% CI, 1.04 to 1.30; P = .009) scores was associated with better survival. This exploratory study found longer survival beyond the 6 months after starting treatment to be associated with fewer problems with dyspnea before treatment and better recovery of physical function, pain, and fatigue after treatment. More research to confirm these findings and understand the results is needed.

The SF-36 and SGRQ: Validity and first look at minimum important differences in IPF

Health-related quality of life (HRQL) is an important outcome in drug trials. Little is known about how the Short Form-36 (SF-36) and Saint George's Respiratory Questionnaire (SGRQ) perform in idiopathic pulmonary fibrosis (IPF). To examine the validity of the SF-36 and SGRQ and to determine scores from each that would constitute a minimum important difference (MID). We analyzed data from a recently completed trial that enrolled subjects with well-defined IPF who completed the SF-36, SGRQ, and Baseline/Transition Dyspnea Index at baseline and six months. We compared mean changes in HRQL scores between groups of subjects whose disease severity changed over six months according to clinical anchors (FVC, DLCO, and dyspnea). We estimated the MID for each domain by using both anchor- and distribution-based approaches. Results supported the validity of the SF-36 and SGRQ for use in longitudinal studies. Mean changes in domain scores differed significantly between subjects whose clinical status improved and those whose clinical status declined according to the anchors. MID estimates for the SF-36 ranged from 2-4 points and from 5-8 points for the SGRQ. In IPF, the SF-36 and SGRQ possess reasonable validity for differentiating subjects whose disease severity changes over time. More studies are needed to continue the validation process, to refine estimates of the MIDs for the SF-36 or SGRQ, and to determine if a disease-specific instrument will perform better than either of these.

Predictive value of serial measurements of quality of life on all-cause mortality in prostate cancer patients: data from CaPSURE™ (cancer of the prostate strategic urologic research endeavor) database

IntroductionHealth-related quality of life (HRQOL) is a legitimate construct for evaluating treatment and its side effects. Recently, predictive value of HRQOL on survival also has been of interest. In light of the longer survival in patients with prostate cancer and importance of quality of life, we seek to evaluate the association between HRQOL and survival using traditional and novel techniques.MethodsPatients from CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) who were treated within 6 months of diagnosis and had pre-treatment and sufficient post-treatment follow-up information constituted the study population. A sample consisting of 2,899 patients met the study criteria. SF-36 domains were used to measure HRQOL outcomes. Categorical variables were created for HRQOL based on the baseline distribution of the lower 10th percentile and the remainder of the patients. Association between HRQOL and survival (defined by all-cause mortality) in patients with prostate cancer was evaluated using Cox proportional hazards models controlling for age at diagnosis, type of treatment received, clinical risk classification, and number of comorbidities. Sequential bootstrap resampling was implemented to evaluate stability of the model. Univariate and multivariate Cox proportional hazards models were fit using various time points over the course of follow-up.ResultsIn the analysis looking at association of HRQOL baseline measurements, higher levels of physical function and general health were significantly associated with better survival (HR 0.49 95% CI 0.32–0.78 and HR 0.51 95% CI 0.35–0.75, respectively). Post-treatment analysis demonstrated similar results. In time-dependent analysis, higher levels of physical function, role physical, and general health were significantly associated with better survival (HR ranged from 0.57 to 0.65). In addition, analysis looking at change in HRQOL scores demonstrated an association between higher scores on physical function, role physical, vitality, social function, and general health and longer survival (HR ranged from 0.56 to 0.63).ConclusionThis study demonstrated that several domains of HRQOL were significantly associated with survival in a large group of patients with localized prostate cancer. This association was maintained over the course of disease regardless of the time of the assessment. Results from our study have both research and clinical relevance. They could provide information that enable us to not only improve communication with patients and families, but also to develop interventions and treatments best suited for the patient.

The Impact of Lifestyle Modification on the Health-Related Quality of Life of Patients With Reflux Esophagitis Receiving Treatment With a Proton Pump Inhibitor

Although lifestyle modification involving diet, exercise, cessation of smoking, etc. is generally advised for patients with reflux esophagitis (RE), few data that show its clinical benefits are available. We analyzed whether lifestyle modification improves health-related quality of life (HRQOL) in Japanese patients with RE receiving the proton pump inhibitor (PPI) lansoprazole as a post hoc analysis of an observational study that investigated the effect of lansoprazole on HRQOL. Patients with RE received lansoprazole for 8 weeks. HRQOL was assessed using the 8-Item Short-Form Health Survey (SF-8) and RE-specific HRQOL questionnaires at baseline and after 4 and 8 weeks of treatment. Physical and mental component summaries (PCS, MCS) and RE-specific summary (RES) scores were calculated. Of the 8,757 patients analyzed, 40.8% were advised regarding new lifestyle at the start of lansoprazole treatment (Group A), 33.3% were advised to continue the lifestyle as advised previously (Group B), and 25.9% did not receive any advice (Group C). The change in PCS from baseline at week 8 for Group A was 5.7 +/- 8.1, and this was significantly greater (P < 0.001) than the increases achieved in Groups B (4.3 +/- 7.5) and C (4.0 +/- 7.6). The changes in MCS and RES were also significantly greater in Group A than in the other groups. The changes in HRQOL scores from baseline were significantly greater in Group A than in the other groups, irrespective of baseline patient characteristics. Lifestyle modification may be clinically beneficial in terms of improving HRQOL in Japanese patients with RE who are receiving treatment with a PPI.

Characteristics affecting health-related quality of life (HRQOL) in Japanese patients with reflux oesophagitis and the effect of lansoprazole on HRQOL

Objectives: A survey of health-related quality of life (HRQOL) in the Japanese general population has suggested that HRQOL is affected by sex and age. We investigated whether there is any effect of baseline patients' characteristics on HRQOL of patients with reflux oesophagitis (RE), and its changes with lansoprazole (LPZ) treatment.Research design and methods: This was a post hoc analysis of an open-label, multicentre, post-marketing, observational study which investigated the effect of LPZ (15 or 30 mg/day for 8 weeks) on HRQOL in patients with RE. At baseline, and after 4 and 8 weeks of treatment, HRQOL was assessed using a Japanese version of the 8-item Short-Form Health Survey (SF-8) and a newly-developed RE-specific questionnaire (RESQ). Stratified analysis of changes in HRQOL scores according to baseline patient characteristics such as sex, age and baseline severity of typical RE symptoms was performed.Results: A total of 8,757 patients were included in the efficacy analysis. At baseline, physical component summary scores from the SF-8 were lower in older patients (≥60 years) than in younger patients (<60 years), and mental component summary scores were lower in younger patients than in older patients. These scores significantly improved after LPZ treatment regardless of sex and age. HRQOL scores were lower in patients with more severe typical RE symptoms at baseline. After LPZ treatment, HRQOL scores significantly improved to similar levels irrespective of the severity of the typical RE symptom at baseline.Conclusions: This post hoc analysis suggests that sex, age and severity of typical RE symptoms affect HRQOL in patients with RE in Japan, and such factors do not affect the improvement of HRQOL with LPZ treatment. The present study suggests a positive impact of LPZ; however, it is difficult to estimate the degree of improvement in HRQOL that may have arisen from symptomatic relief as part of the natural history of the disease from the study. Our results may overestimate the efficacy of LPZ. Further well-controlled clinical studies are needed to confirm the efficacy of LPZ on HRQOL in patients with RE.