Changes In Health-related Quality Of Life Scores Research Articles

Individual changes in neurocognitive functioning and health-related quality of life in patients with brain oligometastases treated with stereotactic radiotherapy

BackgroundRecently, it has been shown that at group level, patients with limited brain metastases treated with stereotactic radiotherapy (SRT) maintain their pre-treatment levels of neurocognitive functioning (NCF) and health-related quality of life (HRQoL). The aim of this study was to evaluate NCF and HRQoL changes over time at the individual patient level.MethodsNCF (seven domains assessed with a standardized test battery) and HRQoL (eight predetermined scales assessed with the EORTC QLQ-C30 and BN20 questionnaires) were measured prior to SRT and at 3 and/or 6 months follow-up. Changes in NCF and HRQoL were evaluated at (1) a domain/scale level and (2) patient level.ResultsA total of 55 patients were examined, of which the majority showed stable NCF 3 months after SRT, on both the domain level (78–100% of patients) and patient level (67% of patients). This was different for HRQoL, where deterioration in the different scales was observed in 12–61% of patients, stable scores in 20–71%, and improvement in 16–40%, 3 months after SRT. At patient level, most patients (64%) showed both improvement and deterioration in different HRQoL scales. Results were similar between 3 and 6 months after SRT.ConclusionIn line with results at group level, most brain oligometastases patients with ≥ 6 months follow-up and treated with SRT maintained their pre-treatment level of NCF during this period. By contrast, changes in HRQoL scores differed considerably at domain and patient level, despite stable HRQoL scores at group level.

Can health-related quality of life (HRQoL) predict conditional survival (CS) in metastatic renal cell carcinoma? Results from a large phase 3 trial.

691 Background: In the absence of mature overall survival (OS) endpoints, interim clinical trial data can be used to predict long-term survival in patients (pts) with advanced malignancies and inform trial continuation, treatment preference, and reimbursement decisions. Research shows that HRQoL assessments can be associated with OS, offering potential utility for validated HRQoL scales. We describe a predictive model used to determine the extent to which HRQoL data could predict CS (survival conditional on progression at either 6 or 12 months). Methods: Using pt-level data from a large phase III trial of nivolumab vs everolimus, a simulation approach with a survival random forest algorithm identified factors statistically important in predicting CS from a large number of covariates measured at baseline. Stepwise Cox proportional hazard survival models were fitted using covariates identified as important. Baseline scores and change over time were tested to determine the influence on the predictive power of the HRQoL data. Results: For both nivolumab and everolimus, baseline FKSI values were significant predictors of CS; median survival times roughly doubled for pts with baseline FKSI scores ≥30 vs pts with scores < 30 (nivolumab, 31.3-16.6; everolimus, 26.6-11). Baseline FKSI scores were the most important predictor vs the other baseline covariates from the survival random forest simulation, and a statistically significant covariate when fitting a stepwise Cox proportional hazard survival model. Change in scores over time influenced CS for pts with high baseline scores, and pts who demonstrated improvement in scores vs baseline had significantly higher CS vs pts with low baseline and no improvement in scores vs baseline. However, when examining change in HRQoL score over time, the statistical importance of the covariate begins to diminish due to high correlations with factors such as adverse events and weight change. Conclusions: We found that HRQoL data, specifically the FKSI, could be useful in predicting CS, especially at the onset of a trial. The importance of the FKSI score in predicting CS could be a powerful complement to existing clinical prognostic factors.

The effect of a randomized controlled physical activity trial on health related quality of life in metabolically unhealthy African-American women: FIERCE STUDY

PurposeAfrican-American women (AAW) are more likely to be metabolically unhealthy than White women (WW). Metabolic syndrome (MetS) is associated with increased breast cancer risk and mortality from breast cancer is greater in AAW compared to WW. Data show MetS affects health-related quality of life (HRQoL). Exercise studies report improvements in MetS, however, no study to date has examined HRQoL in metabolically unhealthy AAW enrolled in an exercise trial. MethodsThis report examined the effect of a 6-month, 3-arm (supervised exercise, home-based exercise, control) randomized exercise controlled trial on HRQoL among 213 obese, metabolically unhealthy, postmenopausal AAW at high risk for breast cancer. ResultsCertain baseline participant characteristics were related to baseline HRQoL dimensions. The “exercise group” (supervised group combined with the home-based group) showed significantly greater improvement in health change scores (M = 13.6, SD = 3.1) compared to the control group (M = 0.7, SD = 4.4) (p = 0.02) over the 6-month study period. There were no significant differences in HRQoL change scores between the 3 study groups, however, although non-significant, data indicated most HRQoL change scores were more favorable in the supervised group. ConclusionWhile significant improvement occurred in health change scores in the combined supervised and home-based group compared to the control group, we did not observe any significant differences on HRQoL change scores between all three study groups. However, while non-significant, there was a trend for more favorable HRQoL change scores in the supervised group versus the home-based and control groups. Additional research is needed to further explore this topic.

Factors affecting patient-reported outcomes after red blood cell transfusion in medical patients.

Physical variables like mortality or cardiac events were used to evaluate the requirement of red blood cell (RBC) transfusion. However, patient-reported outcomes (PROs) of blood transfusion recipients were seldom assessed. The health-related quality of life (HRQoL) of patients before and after RBC transfusion was compared in this study. The study period was February to June 2016. Standardized generic and anemia symptom-specific HRQoL instruments were administered to patients receiving RBC transfusion in the medical unit of a single center. The primary outcome was the change in HRQoL scores on Days 1 and 7 posttransfusion from baseline values on the day of transfusion (Day 0). Multiple linear regression analysis was performed to study the effect of transfusion strategy and other factors on PRO. The analysis included 99 general medical patients. The median (interquartile range) pretransfusion hemoglobin level was 72 (66-78) g/L. Two or more units of RBCs were prescribed to 45 patients (45%) on Day 0. Functional Assessment of Cancer Therapy-Anemia Subscale improved significantly on Days 1 and 7 by effect sizes of 0.41 and 0.38, respectively (p < 0.001). Regression analysis showed that lower baseline HRQoL scores were associated with better PRO on both Day 1 and Day 7 (p < 0.001). Transfusion trigger and number of RBC units transfused did not affect the change in HRQoL. Worse pretransfusion HRQoL is a predictor of improvement in PRO after blood transfusion. There is no evidence that a restrictive transfusion or single-unit policy jeopardizes PRO.

Determining the longitudinal validity and meaningful differences in HRQL of the PedsQL\u2122 Sickle Cell Disease Module

BackgroundDetecting change in health status over time and ascertaining meaningful changes are critical elements when using health-related quality of life (HRQL) instruments to measure patient-centered outcomes. The PedsQL™ Sickle Cell Disease module, a disease specific HRQL instrument, has previously been shown to be valid and reliable. Our objectives were to determine the longitudinal validity of the PedsQL™ Sickle Cell Disease module and the change in HRQL that is meaningful to patients.MethodsAn ancillary study was conducted utilizing a multi-center prospective trial design. Children ages 4–21 years with sickle cell disease admitted to the hospital for an acute painful vaso-oclusive crisis were eligible. Children completed HRQL assessments at three time points (in the Emergency Department, one week post-discharge, and at return to baseline (One to three months post-discharge). The primary outcome was change in HRQL score. Both distribution (effect size, standard error of measurement (SEM)) and anchor (global change assessment) based methods were used to determine the longitudinal validity and meaningful change in HRQL. Changes in HRQL meaningful to patients were identified by anchoring the change scores to the patient’s perception of global improvement in pain.ResultsModerate effect sizes (0.20–0.80) were determined for all domains except the Communication I and Cognitive Fatigue domains. The value of 1 SEM varied from 3.8–14.6 across all domains. Over 50% of patients improved by at least 1 SEM in Total HRQL score. A HRQL change score of 7–10 in the pain domains represented minimal perceived improvement in HRQL and a HRQL change score of 18 or greater represented moderate to large improvement.ConclusionsThe PedsQL™ Sickle Cell Disease Module is responsive to changes in HRQL in patients experiencing acute painful vaso-occlusive crises. The study data establish longitudinal validity and meaningful change parameters for the PedsQL™ Sickle Cell Disease Module.Trial RegistrationClinicalTrials.gov (study identifier: NCT01197417). Date of registration: 08/30/2010

A systematic review of health-related quality of life in longitudinal studies of myeloma patients.

Multiple myeloma (MM) patients report high symptom burden and reduced health-related quality of life (HRQoL) compared to patients with other haematological malignancies. The aim of this review was to analyse published longitudinal studies including MM patients according to a change in HRQoL scores, which is perceived as beneficial to the patient according to two published guidelines. A literature search was performed May 2016. Publications with longitudinal follow-up using the EORTC QLQ-C30 instrument for HRQoL measurement of physical functioning, global quality of life, fatigue and/or pain were included. An analysis of mean change from baseline was carried out according to minimal important difference (MID). Large and medium HRQoL improvements were reported during first-line treatments. No clinically beneficial change or deteriorations in scores of global QoL or fatigue were reported during relapse treatment. HRQoL data during maintenance therapy are sparse and inconclusive. Guidelines for interpreting changes in HRQoL including definitions of MID have been developed; however, consensus is missing. Improvements in HRQoL are far more likely to occur during first-line compared to relapsed treatment regimens. The background of these findings should be in focus in future studies, and HRQoL measurements should be integrated in maintenance studies.

P18.16 Changes in health-related quality of life and neurocognitive functioning in individual patients treated with stereotactic radiotherapy for brain metastases

Abstract Background: Stereotactic radiotherapy (SRT) is believed to result in a similar survival rate as whole-brain radiotherapy for treatment of brain metastases, with a less profound impact on cognition and health-related quality of life (HRQoL). Recently it has been shown that, on group level, brain metastases patients treated with SRT maintain their pre-treatment levels of cognition and HRQoL. Although stable on group level, this may not hold true for individual patients. Objective: We sought to evaluate changes in cognition and HRQoL on the individual patient level three and six months after SRT. Methods: A total of 55 patients completed HRQoL questionnaires and underwent neurocognitive testing prior to SRT and 3 and/or 6 months after SRT. The EORTC QLQ-C30 and BN20 questionnaires were used to assess HRQoL and a standardized test battery to assess neurocognitive functioning. Changes in HRQoL and cognition were evaluated on (1) a scale/domain level and (2) patient level. First, percentage of patients showing a clinically relevant improvement, stable score or deterioration on each of 8 predetermined HRQoL scales and 7 cognitive domains were calculated. Next, patients were categorized into 4 groups, separately for HRQoL and cognition: decline (only worsening of HRQoL or cognition), both (decline and improvement), stable (no detectable change in any scale/domain) and improvement (only improvement). Results: Three months after SRT, a decline in the 8 different HRQOL scales was observed in 16-61% of the patients, while 20-71% remained stable and 16-40% improved. Six months after SRT, 8-47% of the patients had worse scores on the 8 HRQoL scales, 18-75% the same scores and 11-34% better scores. On the 7 different neurocognitive functioning domains, only 3-8% of the patients worsened, 78-100% remained stable, while 3-17% showed an improvement three months after SRT. These percentages were similar six months after SRT; 8-20% of the patients deteriorated on the 7 domains, 73-100% remained stable and 4-8% improved. Changes in HRQoL and cognition on patient level were evaluated for two different time periods (0-3 months and 3-6 months). For HRQoL, 22% and 21% of the patients worsened in the period 0-3 and 3-6 months respectively, 64% and 58% both improved and deteriorated, 2% and 3% were stable and 12% and 18% showed improvement only. For cognition, the percentages were as follows: 14% and 33% showed a decline only, 6% and 4% both a decline and improvement, 67% and 50% stable scores and 14% and 13% an improvement only. Conclusion: In line with the results at group level, most brain metastases patients treated with SRT maintained their pre-treatment levels of cognition for at least 6 months. In contrast, changes in HRQoL scores for the different scales differed considerably on an individual patient level, and most patients showed both deterioration and improvement in various HRQoL scales in the first 6 months after SRT.

Impact of continuous positive airway pressure and oxygen on health status in patients with coronary heart disease, cardiovascular risk factors, and obstructive sleep apnea: A Heart Biomarker Evaluation in Apnea Treatment (HEARTBEAT) analysis

Obstructive sleep apnea (OSA) is associated with impaired health-related quality of life (HRQL). Treatment with continuous positive airway pressure (CPAP) has variable impacts on HRQL, and this may be influenced by patient's tolerance of therapy. The objective is to determine the impact of nocturnal supplemental oxygen (NSO) and CPAP on HRQL compared with healthy lifestyle education (HLSE) in individuals with OSA. Patients with coronary heart disease (CHD) or at least 3 major CHD risk factors with apnea-hypopnea index of 15 to 50 events/h were randomized to CPAP, NSO, or HLSE. Health-related quality of life was assessed using the Short-Form 36, and depression was assessed with Patient Health Questionnaire-9 at baseline and 12 weeks. The treatment effect on HRQL change scores through 12 weeks was assessed using multivariable models adjusting for study site, presence of CHD at baseline, race, and baseline HRQL. A total of 318 patients were randomized to 1 of 3 treatment arms with 1:1:1 ratio and 94% completed baseline and follow-up HRQL instruments. Mean Short-Form 36 scores were similar at baseline in all 3 groups ranging from 41.8±12 to 51.6±12 in various domains. In multivariable models, the CPAP group noted a significantly greater improvement than NSO in mental health (+2.33, 95% CI 0.34-4.31, P=.02) and mental composite score (+2.40, 95% CI 0.40-4.41, P=.02). Conversely, the CPAP group noted less improvement than NSO in physical function (-2.68, 95% CI -4.66 to -0.70, P=.008) and physical composite score (-2.17, 95% CI -3.82 to -0.51, P=.01). Compared with HLSE, vitality and Patient Health Questionnaire-9 improved with CPAP but not with NSO. Significant interactions were noted between treatment effects with larger differences in black and sleepy patients. These data support the use of CPAP for improving vitality, sleepiness, mental health, social functioning, and depressive symptoms in patients with OSA and established CHD or risk factors. Nocturnal supplemental oxygen may have beneficial effects on perceived physical functioning.

The anchor-based minimal important change, based on receiver operating characteristic analysis or predictive modeling, may need to be adjusted for the proportion of improved patients

ObjectivesPatients have their individual minimal important changes (iMICs) as their personal benchmarks to determine whether a perceived health-related quality of life (HRQOL) change constitutes a (minimally) important change for them. We denote the mean iMIC in a group of patients as the “genuine MIC” (gMIC). The aims of this paper are (1) to examine the relationship between the gMIC and the anchor-based minimal important change (MIC), determined by receiver operating characteristic analysis or by predictive modeling; (2) to examine the impact of the proportion of improved patients on these MICs; and (3) to explore the possibility to adjust the MIC for the influence of the proportion of improved patients. Study Design and SettingMultiple simulations of patient samples involved in anchor-based MIC studies with different characteristics of HRQOL (change) scores and distributions of iMICs. In addition, a real data set is analyzed for illustration. ResultsThe receiver operating characteristic–based and predictive modeling MICs equal the gMIC when the proportion of improved patients equals 0.5. The MIC is estimated higher than the gMIC when the proportion improved is greater than 0.5, and the MIC is estimated lower than the gMIC when the proportion improved is less than 0.5. Using an equation including the predictive modeling MIC, the log-odds of improvement, the standard deviation of the HRQOL change score, and the correlation between the HRQOL change score and the anchor results in an adjusted MIC reflecting the gMIC irrespective of the proportion of improved patients. ConclusionAdjusting the predictive modeling MIC for the proportion of improved patients assures that the adjusted MIC reflects the gMIC. Limitations: We assumed normal distributions and global perceived change scores that were independent on the follow-up score. Additionally, floor and ceiling effects were not taken into account.

Health-related quality of life and anxiety and depression in patients diagnosed with cholangiocarcinoma: a prospective cohort study

Background: Cholangiocarcinoma (CCA) is a rare cancer associated with a poor prognosis. Psychosocial challenges may negatively affect daily functioning and health-related quality of life (HRQOL). The primary aim was to evaluate HRQOL, and to assess anxiety and depression in these patients.Material and methods: From 93 eligible patients diagnosed with CCA, 76 were included in a prospective cohort over a period of 15 months. Patients answered the European Organization for Research and Treatment of Cancer QLQ C30 (EORTC QLQ C30) and Hospital Anxiety and Depression Scale (HADS) questionnaires at baseline, one, three and six months after initial treatment; defined as radical operation, explorative laparotomy, chemotherapy or drainage of the bile ducts. Scores were compared between the radically operated patients (n = 25) and palliative patients (n = 51; 12 of these had explorative laparotomy), using repeated measures ANOVA and unpaired ANOVA.Results: The groups were similar in demographic characteristics, except for fewer radically operated men (p = 0.015). There was no significant change over time in HRQOL in total or between groups. At baseline nausea and vomiting scores were higher in the palliative group (p = 0.035), and at one month follow-up, the radical group had higher pain scores (p = 0.009). The majority reported normal/mild anxiety and depression throughout the study; there were no differences between the groups.Conclusions: It was not possible to measure any differences between the groups, regarding HRQOL, anxiety or depression, despite the fact that one of the groups had the prospect of total cure. In clinical settings, observed mean changes in HRQOL scores are generally small; probably due to psychological adaptation by patients to changing health status over time.

Effects of a right unilateral ultrabrief pulse electroconvulsive therapy course on health related quality of life in elderly depressed patients

IntroductionPatients with Major Depressive Disorder (MDD) referred for electroconvulsive therapy (ECT) have poorer Health Related Quality of Life (HRQOL), compared with other patients with MDD, but ECT is associated with significant and durable improvement in HRQOL. However, no prior research has focused exclusively on elderly patients with MDD receiving ECT. MethodsHRQOL data from 240 depressed patients over the age of 60 was measured with the Medical Outcomes Study Short Form 36 (SF-36). The SF-36 was measured before and after a course of acute ECT. Predictors of change in HRQOL scores were identified by generalized linear modeling. ResultsAt baseline, participants showed very poor HRQOL. After treatment with ECT, the full sample showed marked and significant improvement across all SF-36 measures, with the largest gains seen in dimensions of mental health. Across all participants, the Physical Component Summary (PCS) score improved by 2.1 standardized points (95% CI, 0.61,3.56), while the Mental Component Summary (MCS) score improved by 12.5 points (95% CI, 7.2,10.8) Compared with non-remitters, remitters showed a trend toward greater improvement in the PCS summary score of 2.7 points (95%CI, −0.45, 5.9), while the improvement in the MCS summary score was significantly greater (8.5 points, 95% CI, 4.6,12.3) in the remitters than non-remitters. Post-ECT SF-36 measurements were consistently and positively related to baseline scores and remitter/non-remitter status or change in depression severity from baseline. Objective measures of cognitive function had no significant relationships to changes in SF-36 scores. LimitationsThis study's limitations include that it was an open label study with no comparison group, and generalizability is limited to elderly patients. DiscussionECT providers and elderly patients with MDD treated with ECT can be confident that ECT will result in improved HRQOL in the short-term. Attaining remission is a key factor in the improvement of HRQOL. Acute changes in select cognitive functions were outweighed by improvement in depressive symptoms in determining the short term HRQOL of the participants treated with ECT.

Health-Related Quality of Life and Survival of Cholangiocarcinoma Patients in Northeastern Region of Thailand.

In northeast Thailand, cholangiocarcinoma (CCA) is a major cause of mortality. Patients with CCA have a poor prognosis and short-term survival. The purpose of this study was to investigate the association between health-related quality of life (HRQOL) and survival time, and to explore whether change in HRQOL score is related to survival among CCA patients. The study was performed between February 2011 and January 2012, and included 171 patients with newly diagnosed CCA from 5 tertiary hospitals in four provinces of northeast Thailand. The HRQOL was measured at baseline, 1 month, and 2 months after diagnosis by the FACT-Hep questionnaire (Thai version 4). The outcome was survival time from diagnosis. Cox’s proportional hazard model was used to evaluate the association between HRQOL and survival time. A higher overall score on HRQOL was associated with a significantly better survival (HR per 5 units increase in HRQOL was 0.92, 95% CI: 0.88–0.96). Two of the separate domains contributing to the overall HRQOL—functional well-being and hepatobiliary cancer subscale—were found to have independent effects on survival, even after adjustment for potential confounding variables, and the other domains of HRQOL. CCA patient whose HRQOL scores had improved (≥9 units) at the 1st month of follow up had a reduced probability of dying from the disease (HR: 0.56, 0.32–0.95) after adjustment for the same confounding factors. A positive association between HRQOL at diagnosis and survival time was found. An improvement in HRQOL score in the first months after diagnosis further increases survival.

Evaluation of patient-reported outcomes data in structured diabetes education intervention: 2-year follow-up data of patient empowerment programme.

To examine the effects of a structured group-based education programme, patient empowerment programme (PEP), compared with usual care on 2-year changes in patient-reported outcomes (PRO) in patients with diabetes mellitus (DM). A prospective observational study of 715 patients (PEP/non-PEP: 390/325) was conducted to complete the baseline PRO survey and followed up for 2 years. Health-related quality of life (HRQOL) was measured using the short-form 12 at baseline and annually at two follow-up assessments, which yielded physical and mental component summary and SF-6D preference-based scores. Perceived control over diabetes and general health status were measured using the patient enablement instrument (PEI) and global rating scale (GRS) at follow-ups. When compared with non-PEP, PEP participants significantly reported improvement in health condition (GRS score > 0; 24.55 % vs 10.16 %; odds ratio = 2.502; P = 0.018) in 2 years and enabled the self-perceived control over diabetes (PEI score > 0; 72.20 % vs 38.40 %; odds ratio = 3.25; P < 0.001) in 1-year follow-up but no sustained effects in year 2 (52.65 % vs 39.04 %; odds ratio = 1.366; P = 0.265). There were no significant differences between PEP and non-PEP groups in the changes in quality of life scores (all P > 0.05) at 1 year. Although HRQOL scores deteriorated over 2-year period in both groups, PEP participants reported similar changes in HRQOL scores to that of non-PEP. PEP for DM patients preserved self-perceived disease control and health condition, whereas PEP participants perceived their HRQOL similar to that of non-PEP participants. Findings of PRO should be considered alongside clinical outcomes when evaluating the overall benefits of PEP.

Impact of emergency department care on outcomes of acute pain events in children with sickle cell disease.

The impact of emergency department (ED) treatment on outcomes of sickle cell disease (SCD) acute pain hospitalizations is not well described. We investigated whether length of stay (LOS) and change in health-related quality of life (HRQL) are affected by initial opioid dose and time to administration. We conducted secondary analyses of data from the randomized-controlled Magnesium for children in Crisis (MAGiC) trial. The primary outcome was LOS. Secondary outcome was change in HRQL, assessed using PedsQL SCD Pain and Hurt and Pain Impact Domains measured in ED and at discharge. Independent variables were (1) time to first IV opioid, (2) total initial opioid dose (mg/kg/hr of morphine equivalents administered between ED and first study drug), and (3) Time to first oral opioid. Spearman correlations determined the associations with LOS. Using two-sample t-tests, we compared mean change in HRQL scores between IV opioid initiated within 60 and >60 min, opioid doses in the highest and lowest tertiles, and oral opioid initiated within 24 and >24 hr. Two hundred and four patients participated at 8 sites. Mean (SD) age was 13.6 (4.7) years. Earlier initiation of oral opioids was strongly correlated with shorter LOS (r = 0.61, P < 0.01). Higher initial opioid dose was weakly correlated with longer LOS (r = 0.34, P < 0.01). Higher initial opioid doses (6 vs -2.2; P = 0.01) and oral opioids initiated within 24 hr (5.7 vs -1.7, P = 0.04) were associated with larger mean change in HRQL at discharge. Prospective trials evaluating the impact of ED care on outcomes of pain hospitalizations could improve SCD pain treatment. Am. J. Hematol. 91:1175-1180, 2016. © 2016 Wiley Periodicals, Inc.

Quality of Life After Stereotactic Ablative Radiotherapy for Early-Stage Lung Cancer: A Systematic Review

BackgroundStereotactic ablative radiotherapy (SABR) has recently become the guideline-recommended therapy for inoperable patients with early-stage non–small-cell lung cancer (ES-NSCLC) and for patients who decline surgery. Patient-reported outcomes should be a key consideration for any treatment modality; however, to our knowledge, a systematic review of the effects of SABR on health-related quality of life (HRQOL) in this patient population is not yet available. Materials and MethodsThe Embase and MEDLINE databases were queried to obtain journal studies investigating patient-reported HRQOL after SABR for ES-NSCLC. Studies in the English language were included up to August 1, 2015. Relevant data regarding patient characteristics and study outcomes were abstracted and analyzed. ResultsOf the 204 potential studies, 9 met all the inclusion criteria and their data were analyzed. All the studies were prospective in design, ranged in date from 2010 to 2015, and involved patients from Europe and North America. The reviewed studies reported few clinically significant changes in HRQOL scores after SABR. Clinically and statistically significant deteriorations in fatigue and dyspnea were individually reported in 2 studies, but these findings were not replicated by other studies. ConclusionPost-treatment HRQOL scores indicate that SABR is an overall well-tolerated modality for patients with ES-NSCLC who either declined or were unfit for surgery. Future clinical trials comparing SABR and surgery would benefit from the inclusion of HRQOL metrics in the study design.

Low-Fat Dietary Pattern Intervention and Health-Related Quality of Life: The Women’s Health Initiative Randomized Controlled Dietary Modification Trial

BackgroundIntensive dietary intervention programs may lead to benefits in vitality and other components of health quality. The Women's Health Initiative Dietary Modification (DM) intervention includes a large randomized controlled trial of an intensive intervention. ObjectiveTo evaluate whether the intervention is associated with improved health-related quality of life (HRQoL) subscales, overall self-reported health, depression symptoms, cognitive functioning, and sleep quality. DesignThis randomized controlled trial was analyzed as intent to treat. ParticipantsBetween 1993 and 1998, 48,835 women aged 50 to 79 years were recruited by 40 clinical centers across the United States. Eligibility included having fat intake at baseline ≥32% of total calories, and excluded women with any prior colorectal or breast cancer, recent other cancers, type 1 diabetes, or medical conditions with predicted survival <3 years. InterventionGoals were to reduce calories from fat to 20%, increase vegetables and fruit to 5+ servings, and increase grain servings to 6+ servings a day. During the first year, 18 group sessions were held, with quarterly sessions thereafter. Main outcome measuresThe RAND 36-Item Health Survey was used to assess HRQoL at baseline, Year 1, and close-out (about 8 years postrandomization), and estimate differential HRQoL subscale change scores. Statistical analyses performedMean change in HRQoL scores (Year 1 minus baseline) were compared by randomization group using linear models. ResultsAt 1 year, there was a differential change between intervention and comparison group of 1.7 units (95% CI 1.5, 2.0) in general health associated with the intervention. DM intervention improved physical functioning by 2.0 units (95% CI 1.7, 2.3), vitality by 1.9 units (95% CI 1.6, 2.2), and global quality of life by 0.09 units (95% CI 0.07, 0.12). With the exception of global quality of life, these effects were significantly modified by body mass index at baseline. ConclusionsDM intervention was associated with small, but significant improvements in three HRQoL subscales: general health, physical functioning, and vitality at 1 year follow-up, with the largest improvements seen in the women with the greatest baseline body mass index.

Health-Related Quality of Life in SCALOP, a Randomized Phase 2 Trial Comparing Chemoradiation Therapy Regimens in Locally Advanced Pancreatic Cancer

PurposeChemoradiation therapy (CRT) for patients with locally advanced pancreatic cancer (LAPC) provides survival benefits but may result in considerable toxicity. Health-related quality of life (HRQL) measurements during CRT have not been widely reported. This paper reports HRQL data from the Selective Chemoradiation in Advanced Localised Pancreatic Cancer (SCALOP) trial, including validation of the QLQ-PAN26 tool in CRT.Methods and MaterialsPatients with locally advanced, inoperable, nonmetastatic carcinoma of the pancreas were eligible. Following 12 weeks of induction gemcitabine plus capecitabine (GEMCAP) chemotherapy, patients with stable and responding disease were randomized to a further cycle of GEMCAP followed by capecitabine- or gemcitabine-based CRT. HRQL was assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the EORTC Pancreatic Cancer module (PAN26).ResultsA total of 114 patients from 28 UK centers were registered and 74 patients randomized. There was improvement in the majority of HRQL scales during induction chemotherapy. Patients with significant deterioration in fatigue, appetite loss, and gastrointestinal symptoms during CRT recovered within 3 weeks following CRT. Differences in changes in HRQL scores between trial arms rarely reached statistical significance; however, where they did, they favored capecitabine therapy. PAN26 scales had good internal consistency and were able to distinguish between subgroups of patients experiencing toxicity.ConclusionsAlthough there is deterioration in HRQL following CRT, this resolves within 3 weeks. HRQL data support the use of capecitabine- over gemcitabine-based chemoradiation. The QLQ-PAN26 is a reliable and valid tool for use in patients receiving CRT.

Postoperative apathy can neutralise benefits in quality of life after subthalamic stimulation for Parkinson's disease

BackgroundSubthalamic nucleus deep brain stimulation (STN-DBS) improves motor symptoms of Parkinson's disease, leading to improvement in health-related quality of life (HRQoL). However, an excessive decrease in dopaminergic medication can lead...

Semantic primes theory may be helpful in designing questionnaires such as to prevent response shift

ObjectivesThe purpose of randomized control trials (RCTs) can be the assessment of the direct effect of treatment on health-related quality of life (HRQL). Response shift (RS) theory considers that a change in HRQL scores observed over time cannot be explained solely by a direct effect of a medical condition, it may also result from a change in the way people appraise their HRQL. The RS effect is a potential bias that is liable to compromise efficient assessment of the effect of treatment on HRQL. Study Design and SettingWe hypothesize a link between the RS effect on HRQL scores and the level of complexity of HRQL conceptualization. ResultsWe discuss how the impact of reconceptualization on scores depends on the complexity of the linguistic definition of a subjective construct and how for reprioritization the impact depends on the dimensionality. The linguistic theory of semantic primes is used to help identify how subjective constructs can be classified according to the complexity of their definitions. ConclusionFinally, we suggest that the impact of the RS effect on HRQL scores could be avoided (or lessened) if questionnaires were designed with a rule of “the least semantic and psychometric complexity” in mind.

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.