Health-related Quality Of Life Component Research Articles

Differences in quality-of-life scores across injury categories by mental health status among injured U.S. military service members and veterans.

Posttraumatic stress disorder (PTSD) and depression are strong predictors of poor health-related quality of life (HRQOL) among injured U.S. military service members (SMs). Patterns of HRQOL between injury categories and injury categories stratified by mental health (MH) symptoms have not been examined. Among deployment-injured SMs and veterans (n = 4353), we examined HRQOL and screening data for PTSD and/or depression within specific injury categories. Participants included those enrolled in the Wounded Warrior Recovery Project with complete data for HRQOL (SF-36) from June 2017 to May 2020. Injuries were categorized using the Barell Injury Diagnosis Matrix (Barell Matrix). Mean physical component summary (PCS) and mental component summary (MCS) scores were calculated for each injury category and stratified by the presence or absence of probable PTSD and/or depression. The average follow-up time that participants were surveyed after injury was 10.7years. Most participants were male, non-Hispanic White, served in the Army, and enlisted rank. Mechanism of injury for 77% was blast-related. Mean PCS and MCS scores across the entire sample were 43.6 (SD = 10.3) and 39.5 (SD = 13.3), respectively; 50% screened positive for depression and/or PTSD. PCS and MCS scores were significantly lower within each injury category among individuals with probable PTSD and/or depression than those without. Among deployment-injured SMs, those with probable PTSD and/or depression reported significantly lower HRQOL within injury categories and HRQOL component (i.e., physical or mental) than those without. Findings are consistent with prior reports showing mental health symptoms to be strongly associated with lower HRQOL and suggest integration of mental health treatment into standard care practices to improve long-term HRQOL.

Health-Related Quality of Life Sleep Score Predicts Transfer to Hemodialysis among Patients on Peritoneal Dialysis.

Despite the superiority of peritoneal dialysis (PD) over hemodialysis (HD) regarding health-related quality of life (HRQOL), the specific HRQOL domain(s) that predict unplanned HD transfer remains uncertain. In this cohort study, we assessed the HRQOL of 50 outpatients undergoing PD using the Japanese version 1.3 Kidney Disease Quality of Life-Short Form from March 2017 to March 2018 and prospectively analyzed the association of each HRQOL component with HD transfer until June 2021. During the follow-up (41.5 (13.0–50.1) months), 21 patients were transferred to HD. In a multivariate Cox proportional hazards model adjusted for age, sex, PD vintage, urine output, Charlson comorbidity index, and incremental shuttle walking test, a higher sleep score was significantly associated with lower HD transfer rates (HR 0.70 per 10, p = 0.01). An adjusted subdistribution hazard model where elected transition to HD, death, and transplantation were considered competing events of unintended HD transfer that showed sleep score as an exclusive predictor of HD transfer (HR 0.70 per 10, p = 0.002). Our results suggest that sleep score among the HRQOL subscales is instrumental in predicting HD transfer in patients undergoing PD.

Severity of protein-energy wasting and obesity are independently related with poor quality of life in peritoneal dialysis patients

Protein-energy wasting (PEW) and poor health-related quality of life (HRQoL) are independently associated with morbi-mortality in continuous ambulatory peritoneal dialysis (CAPD). PEW may reduce HRQoL; however, we hypothesized HRQoL is affected differentially by PEW degrees or by individual criteria of nutritional status. AimTo evaluate HRQoL according to PEW severity and nutritional status indicators in CAPD.This is a cross-sectional study in 151 patients. Subjective global assessment (SGA) was employed, and nutritional status classified as normal, mild-moderate PEW, and severe PEW. HRQoL was evaluated using Kidney Disease Quality of Life Short Form™, including physical (PCS), mental (MCS) and kidney disease (KDCS) components, and their subscales. Dietary intake, anthropometric and biochemical variables were measured.Forty-six percent of patients were well-nourished, 44% had mild-moderate PEW, and 10% severe PEW. Compared with well-nourished patients, those with mild-moderate (p=0.06) and severe (p=0.005) PEW had lower HRQoL score [68 (52–75), 55 (45–72), 46 (43–58), respectively]. PCS, MCS, and KDCS and their subscales had lower values as PEW was more severe. Patients with obesity and hypoalbuminemia had significantly lower HRQoL overall and component scores than their counterparts. Dietary intake was not associated with quality of life. In multivariate analysis obesity, PEW (by SGA), hypoalbuminemia, and low educational level predicted poor HRQoL (χ2 58.2, p<0.0001).As conclusion, PEW severity was related with worse HRQoL, either as overall score or in every component or subscale in CAPD patients. Poor HRQoL was predicted independently by PEW severity and obesity; additional predictors were hypoalbuminemia and low education.

Cognitive Functioning Mediates the Association of Cognitive Reserve with Health-Related Quality of Life

We investigated whether the relations of the cognitive reserve markers education and cognitive level of work to the physical and the mental component of health-related quality of life (HRQoL) were mediated via cognitive functioning in a large sample of 701 older adults (mean age = 70.36 years, SD = 6.87). HRQoL was measured with the 12-item Short-Form Health Survey. To measure cognitive functioning, we used the COGTEL, which is a cognitive test battery assessing prospective memory, verbal short-term memory, verbal long-term memory, working memory, verbal fluency, and inductive reasoning, combined into a composite score. Individuals reported information on their education and their main profession during their working life. Mediation analyses showed that better cognitive functioning mediated the association of higher values in the cognitive reserve markers (longer education and a high cognitive level of work) with higher HRQoL. In conclusion, the present study suggests that the sustainability of cognitive functioning in old age with the help of cognitive reserve is fundamental for the sustainability of quality of life, presumably particularly for the mental HRQoL component.

Severity of protein-energy wasting and obesity are independently related with poor quality of life in peritoneal dialysis patients

Protein-energy wasting (PEW) and poor health-related quality of life (HRQoL) are independently associated with morbi-mortality in continuous ambulatory peritoneal dialysis (CAPD). PEW may reduce HRQoL; however, we hypothesized HRQoL is affected differentially by PEW degrees or by individual criteria of nutritional status. AimTo evaluate HRQoL according to PEW severity and nutritional status indicators in CAPD.This is a cross-sectional study in 151 patients. Subjective global assessment (SGA) was employed, and nutritional status classified as normal, mild-moderate PEW, and severe PEW. HRQoL was evaluated using Kidney Disease Quality of Life Short Form™, including physical (PCS), mental (MCS) and kidney disease (KDCS) components, and their subscales. Dietary intake, anthropometric and biochemical variables were measured.Forty-six percent of patients were well-nourished, 44% had mild-moderate PEW, and 10% severe PEW. Compared with well-nourished patients, those with mild-moderate (p=0.06) and severe (p=0.005) PEW had lower HRQoL score [68 (52–75), 55 (45–72), 46 (43–58), respectively]. PCS, MCS, and KDCS and their subscales had lower values as PEW was more severe. Patients with obesity and hypoalbuminemia had significantly lower HRQoL overall and component scores than their counterparts. Dietary intake was not associated with quality of life. In multivariate analysis obesity, PEW (by SGA), hypoalbuminemia, and low educational level predicted poor HRQoL (χ2 58.2, p<0.0001).As conclusion, PEW severity was related with worse HRQoL, either as overall score or in every component or subscale in CAPD patients. Poor HRQoL was predicted independently by PEW severity and obesity; additional predictors were hypoalbuminemia and low education.

Alexithymia and Somatization in Chronic Pain Patients: A Sequential Mediation Model.

ObjectiveTo investigate whether chronic pain (CP) patients with somatization reported higher alexithymic traits than those without somatization and to study the different relationships between psychological characteristics, pain, health-related quality of life (HRQL), and somatization.MethodA consecutive sample of 134 CP treatment-seeking outpatients were evaluated for alexithymia (TAS-20), somatization (PHQ-15), distress (HADS), HRQL (SF-12), and pain (BPI).ResultsPatients with somatization (37.04%) reported significantly higher TAS-20 total scores (p < 0.001) and difficulty in identifying feelings (DIF) (p < 0.001) than those without somatization. The somatizer group had also a significantly higher disease duration, severity and interference of pain, distress, and lower HRQL than the non-somatizer group. Hierarchical regression analysis showed that although distress, pain interference and the mental HRQL component are closely related to somatization (R2 = 0.55), DIF was the strongest predictor of severity of somatization (β = 0.31). A sequential indirect effect from DIF to somatization via distress symptoms and pain interference turned out to be significant [95% CI (0.01, 0.09)]. Support was also found for sequential mediation paths from DIF to somatization via distress and mental HRQL [95% CI (0.01, 0.11)].ConclusionsOur results pointed-out that alexithymia, particularly DIF, may be major factor for somatization risk in CP patients. Longitudinal observations are needed for evaluating the role of alexithymia in clinical outcomes.

Quality of life, physical activity and cardiorespiratory fitness in black African women: B-Healthy project.

To study the associations between physical activity (PA), cardiorespiratory fitness (CRF), and health-related quality of life (HRQoL) in black African women from a low socioeconomic community in South Africa. Black African women (n = 146) aged 35-75years from a low socioeconomic community in South Africa participated in this study. We measured PA levels via ActiHeart® accelerometers, and CRF by measuring peak oxygen consumption (V̇O2 peak). HRQoL was assessed once with the SF-8 Health Survey (SF-8). Participants were classified into groups based on age, moderate to vigorous PA (MVPA), and V̇O2 peak. Logistic regressions were used to compare the odds of having total HRQoL component scores above reported norms across PA and fitness groups. Two multiple linear regression models were developed using physical component summary (PCS) and mental component summary (MCS) as response variables respectively. V̇O2 peak and MVPA varied considerably across the sample and declined with increasing age. Participants in higher quartiles of MVPA and CRF showed trends to higher PCS scores. For CRF these trends were statistically significant, and persisted after adjustment for age and other possible confounders (p = 0.036). PCS was significantly associated with age, relative V̇O2 peak, and income (all p < 0.05), while MCS was associated with income (p = 0.028). CRF is the most significant predictor, together with age and income, on the PCS of the HRQoL among black African women. We recommend that when seeking improvements in HRQoL, interventions should focus on improving CRF, particularly V̇O2 peak.

PRS60 IMPACT OF SLEEP DISTURBANCE ON HEALTH-RELATED QUALITY OF LIFE IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD): WHAT DO WE KNOW SO FAR?

Extrapulmonary impacts of chronic obstructive pulmonary disease (COPD) often include sleep disturbance, poor sleep quality, and daytime sleepiness resulting in detrimental impact on patients' overall health-related quality of life (HRQoL). This study evaluated the impact of sleep disturbance on HRQoL in patients with COPD. Literature searches were performed in biomedical databases until March 2019. Specific search terms identified observational studies assessing HRQoL in COPD that included sleep as a patient-reported outcome (PRO) endpoint. Only full text articles published in English were included. Out of total 1247 abstracts identified for initial screening, 177 were selected for full text review. Based on the inclusion criteria, PRO-related information from 36 studies are analyzed. Sleep disturbances and poor sleep quality was on average prevalent in more than one-third, ranging from 27%-100% of COPD patients. Sleep measures such as the Pittsburgh Sleep Quality Index (PSQI), PROMIS-sleep disturbance domain, Epworth Sleepiness Scale (ESS), Insomnia Severity Index (ISI), and COPD and Asthma Sleep Impact Scale (CASIS) showed significant correlations (all p<0.05) with HRQoL [determined by COPD Assessment Test (CAT), 36-Item Short Form Health Survey (SF-36), the Nottingham Health Profile (NHP) and the St George's Respiratory Questionnaire (SGRQ)]. Univariate and multivariate analyses showed that sleep quality (evaluated by PSQI) is an important determinant for HRQoL in COPD. Furthermore, HRQoL is an important predictor of sleep quality, thereby establishing bidirectional relationship. “Good sleepers” (PSQI<5) have better HRQoL compared to “poor sleepers” (PSQI≥5). Increased sleep disturbance is associated with emotional impact. Both significant (all p<0.05) and non-significant (all p>0.05) results were seen for associations of sleep with disease severity. Overall, there is a bidirectional relationship of sleep quality and HRQoL in COPD. Sleep quality is an independent significant predictor of HRQoL in COPD. Hence, sleep should be considered an important HRQoL component when evaluating the health status of COPD patients.

MON-LB042 Health-Related Quality of Life in Women with Polycystic Ovary Syndrome/Anovulatory Androgen Excess versus Local Population-Based Control Women (from the British Columbia Canadian Multicentre Osteoporosis Study [BC CaMos

Polycystic Ovary Syndrome (PCOS) affects 5-20% of reproductive-aged women and is associated with lower Health-Related Quality of Life (HRQoL)1,2,3. HRQoL in PCOS, however, is often determined in small or clinical samples with no or convenience sample controls. Our aim was to cross-sectionally compare generic SF-36 HRQoL results in community dwelling, physician-diagnosed women with PCOS to randomly selected age-similar local women. Women with PCOS/AAE had enrolled in two local studies (n = 93)4, and were eligible if they were non-menopausal and had PCOS based on Androgen Excess/PCOS Society criteria. Eligibility in both groups required age ≤53 years and, for controls, menstruation in the last year. Control women were from both Adult and Youth BC CaMos cohorts (n = 56). All completed the interviewer-administered CaMos questionnaire5. Statistical analysis used descriptive, T-test and multiple regression to explore relationships among HRQoL domains/component scores versus demographic, anthropomorphic and comorbid condition variables, particularly body mass index (BMI), physical activity patterns and combined hormonal contraceptive (CHC) usage. We compared SF-36 data in pre/perimenopausal women mean aged 34.5±10.0 (SD) years, BMI 27.5±7.5. After controlling for BMI, education, comorbidities and past use of CHC, all HRQoL domain and component scores were significantly lower in women with PCOS then in controls. Domain score differences of 5 are clinically important; PCOS women scored -5.8 to -19.9 points lower (mean -11.6) with the greatest difference for Emotional Role. The Physical Component summary score was -2.2 and the Mental Component summary -7.2 lower in women with PCOS compared with population-based controls; score differences of 2-3 are considered clinically important. In both groups, participation in regular exercise was the strongest predictor of higher overall HRQoL. In both cohorts, comorbidity negatively predicted the physical component score (PCS) of HRQoL; PCOS status negatively predicted the mental component score of HRQoL. PCS group differences became less significant as BMI increased, but MCS remained significantly different. This first comparison of the validated, generic SF-36 in pre/perimenopausal population-based versus women with PCOS documented highly significantly lower scores in women with PCOS on all domains and both components. These data confirm evidence that participation in regular exercise is related to better overall HRQoL in PCOS. Also, obesity in women with PCOS, in contrast to controls, was not associated with the overall HRQoL. We also found that CHC was associated with general health, mental health and mental component scores in women with PCOS. Ref.1Prior JCEM 2014; 2Alvarez-Blasco Clin Endo 2010; 3Azziz Fertil Steril 2009; 4Kalyan Sci Reports 2017; 5Kreiger Can J. Aging 1999. Unless otherwise noted, all abstracts presented at ENDO are embargoed until the date and time of presentation. For oral presentations, the abstracts are embargoed until the session begins. s presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.

The frequency and availability of population-specific patient reported outcome measures and minimal clinically important differences among approved drugs in Canada

BackgroundPatient reported outcome measures (PROMs) and minimal clinically important differences (MCIDs) are included in Canada’s Common Drug Review (CDR) process to approve new drugs. Often, the measures report on the health-related quality of life (HRQoL), but can also describe the symptoms, efficacy and harms important to patients. They can be generic or population/condition specific, validated or not. We examined the frequency, availability and accessibility of validated, specific PROMs and MCIDs reported in the CDR reports.MethodsWe searched the Canadian Agency for Drugs and Technologies in Health (CADTH) on-line database for completed Common Drug Review, Clinical Review Reports (CDR-CRR) between November 2013 and February 2017. Two independent reviewers examined the reports and references for PROMs and MCIDs. Both reviewers separately categorized the PROMs and MICDs according to purpose, validation, availability and funding received. Discrepancies were rectified by consensus with a third investigator.ResultsOne-hundred and five unique PROMs were extracted from 39 CDR-CRR, 57% with a HRQoL component. 91/105 (87%) referenced a validation study and 62/105 (59%) referenced a validation study in the study population of interest. Fifty-seven MCID references were extracted from 39 CDR-CRR. 34/57 (60%) were specific to the study population of interest, and 36% had a HRQoL component. 50% of PROM and 53% of MCID references were publicly available.ConclusionsPROMs and MCIDs referenced in CDR-CRR show similar trends. The majority are validated, but not necessarily in the study population of interest. Continued critical examination is required to evaluate new drugs specific to the population of interest.

Child maltreatment as a social determinant of midlife health-related quality of life in women: do psychosocial factors explain this association?

We examined if child maltreatment (CM) is associated with worse health-related quality of life (HRQoL) in midlife women and if the association is mediated by psychosocial factors. A total of 443 women were enrolled in the Pittsburgh site of the longitudinal Study of Women's Health Across the Nation-Mental Health Study. The analytic sample included 338 women who completed the SF-36 and the Childhood Trauma Questionnaire. Generalized linear regression was used to assess the association between CM and two HRQoL component scores. Structural nested mean models were used to evaluate the contribution of each psychosocial mediator (lifetime psychiatric history, depressive symptoms, sleep problems, very upsetting life events, low social support) to the association. Thirty-eight percent of women reported CM. The mean mental (MCS) and physical (PCS) SF-36 component scores were 2.3 points (95% CI - 4.3, - 0.3) and 2.5 points (95% CI - 4.5, - 0.6) lower, respectively, in women with any CM than in those without. When number of CM types increased (0, 1, 2, 3+ types), group mean scores decreased in MCS (52, 51, 48, 47, respectively; p < .01) and PCS (52, 52, 49, 49, respectively; p = .03). In separate mediation analyses, depressive symptoms, very upsetting life events, or low social support, reduced these differences in MCS, but not PCS. CM is a social determinant of midlife HRQoL in women. The relationship between CM and MCS was partially explained by psychosocial mediators. It is important to increase awareness among health professionals that a woman's midlife well-being may be influenced by early-life adversity.

PHP146 - The Frequency and Availability of Population-Specific Patient Reported Outcome Measures and Minimal Clinically Important Differences Among Approved Drugs in Canada

Patient reported outcome measures (PROMs) and minimal clinically important differences (MCIDs) are included in Canada’s Common Drug Review (CDR) process to approve new drugs. Often, the measures report on the health-related quality of life (HRQoL), but can also describe the symptoms, efficacy and harms important to patients. They can be generic or population/condition specific, validated or not. We examined the frequency, availability and accessibility of validated, specific PROMs and MCIDs reported in the CDR reports. We searched the Canadian Agency for Drugs and Technologies in Health (CADTH) on-line database for completed Common Drug Review, Clinical Review Reports (CDR-CRR) between November 2013 and February 2017. Two independent reviewers examined the reports and references for PROMs and MCIDs. Both reviewers separately categorized the PROMs and MICDs according to purpose, validation, availability and funding received. Discrepancies were rectified by consensus with a third investigator. One-hundred and five unique PROMs were extracted from 39 CDR-CRR, 57% with a HRQoL component. 91/105 (87%) referenced a validation study and 62/105 (59%) referenced a validation study in the study population of interest. Fifty-seven MCID references were extracted from 39 CDR-CRR. 34/57 (60%) were specific to the study population of interest, and 36% had a HRQoL component. 50% of PROM and 53% of MCID references were publicly available. PROMs and MCIDs referenced in CDR-CRR show similar trends. The majority are validated, but not necessarily in the study population of interest. Continued critical examination is required to evaluate new drugs specific to the population of interest.

Does quality of developmental care in NICUs affect health-related quality of life in 5-y-old children born preterm?

Preterm birth and Neonatal Intensive Care Unit (NICU) stay are early adverse experiences, which may affect health-related quality of life (HRQoL) even in the absence of prematurity-related morbidities. The aim of this multicenter longitudinal study was to examine the relation between quality levels of NICU Developmental Care (DC) and HRQoL at 60 mo in children who were born preterm. HRQoL of 102 very preterm (VPT) children from 20 NICUs and 110 full-term controls was assessed using TNO-AZL Preschool Children's Quality of Life Questionnaire (TAPQOL). In VPT children, we compared HRQoL by splitting NICUs into units with high- and low-quality of DC according to the following two factors: (i) the infant centered care (ICC), and (ii) the infant pain management (IPM). Compared to VPT children from NICUs with high-quality of ICC, VPT children from NICUs with low-quality in ICC scored lower in HRQoL component which resulted from the aggregation of lively, positive emotionality, social and motor functioning. No differences were found between VPT children from high-quality ICC NICUs and full-term children and for the IPM index. Findings suggest that higher quality of DC in NICU related to ICC might mitigate long-term negative quality of life outcomes.

Social participation and health-related quality of life in people with multiple sclerosis

BackgroundSocial participation is an integral part of everyday life in society; however, evidence about its association with health-related quality of life (HRQoL) in people with multiple sclerosis (MS) is lacking. ObjectiveThe aim of this study is to explore whether social participation is associated with the Physical Component Summary of HRQoL (PCS) and Mental Component Summary of HRQoL (MCS) in people with MS, controlled for age, gender, disease severity and disease duration. MethodsThe sample consisted of 116 consecutive people with MS (response rate: 75.8%; 72.4% women; mean age 40.3 ± 9.8). People with MS completed the Short-Form Health Survey (SF-36) for measuring PCS and MCS and the Participation Scale, which measures the level of social participation. Disability was assessed using the Expanded Disability Status Scale (EDSS). The associations between social participation, PCS and MCS, were analyzed using linear regression that controlled for sociodemographic and clinical variables. ResultsPCS was significantly associated with age, disease duration, EDSS and social participation. MCS did not show significant association with the studied variables. Overall, a multiple regression model explained 48% of the PCS variance, while the proportion of MCS variance explained was not significant. ConclusionsSocial participation was significantly associated with PCS, suggesting a possibility for intervention in this domain.

The impact of overweight and obesity on health-related quality of life and blood pressure control in hypertensive patients

Hypertension and obesity deteriorate patient health-related quality-of-life (HRQoL). This study assessed the impact of overweight and obesity on HRQoL and blood pressure (BP) control in hypertensive participants, according to sex. HRQoL was assessed using the 12-item Short Form Health Survey in 11,498 white patients treated for hypertension for at least 12 months. Nutritional status was diagnosed according to WHO criteria. Overweight and obesity were associated with worse BP control, regardless of sex. In women, overweight and especially obesity were inversely associated with all analyzed HRQoL dimensions. Among men, obesity decreased all HRQoL dimensions, and overweight influenced only physical functioning, role physical, bodily pain, vitality, general health, and Physical Component Score (PCS) but not Mental Component Score (MCS). Overweight in men did not influence social functioning, or emotional and mental health. The BMI values associated with optimal PCS and MCS scores were higher for men than for women. Age-adjusted multivariate regression analysis revealed that PCS score was associated with obesity, higher education level, comorbidities, and antihypertensive therapy duration, whereas MCS score was associated with female sex. Polydrug BP control diminished PCS and MCS. Overweight and obesity deteriorate BP control, regardless of age and polytherapy. BMI values associated with optimal HRQoL are higher for men than women treated for hypertension. Obesity more strongly diminishes the physical versus mental HRQoL component, regardless of sex. Overweight worsens HRQoL physical components in both sexes and mental component-only in women.

Quality of life in a multicenter phase II trial of metastasectomy for intra- and extra-hepatic metastases from colorectal adenocarcinoma.

e14573 Background: The combination of intra- and extra-hepatic metastases (IHM and EHM) from colorectal cancer (CRC) has traditionally been considered a contraindication for surgery. Currently there is a growing interest in resecting IHM and EHM. The purpose of this study was to evaluate the health related quality of life (HRQoL) of patients with IHM and EHM from CRC undergoing complete metastasectomy. Methods: Participants with any number of CRC IHM and up to 3 foci of EHM, resectable with RO intent were eligible for the HRQoL component of a Phase-II multi-institutional trial. The effects of therapy on HRQoL were evaluated using: EORTC-QLQ C30, EORTC-LMC21 and FACT-HEP at baseline, prior to surgery and at 4, 8 and 12 months following complete metastasectomy. Results were compared to baseline. &gt;10% mean score change was considered a minimally important clinical difference (MICD). Results: Twenty-five participants were enrolled with a median age: 57 (range: 32-84) years. Protocol surgery was completed in 18/25 (72%) including 11/25 (44%) staged resections. Perioperative morbidity and mortality was 11/25 (44%) and 1/25 (4%), respectively. Median disease-free survival was 6 (range: 0-17) months. 22/25, 88% participants underwent perioperative chemotherapy. EORTC-QLQ C30 Global-HRQoL remained statistically and clinically unchanged compared to baseline at 4 and 8 months but had a MCID decrease at 12 months (mean score change: 15.3) that was not statistically significant. This was associated with a significant decrease in social and role functioning and an increase in fatigue, pain and dyspnea. FACT-Hep score was statistically lower at 4 months post surgery, without reaching a MICD. There was no difference in any of the subscales analyzed in regards to sex, age or the presence of peri-operative complications. Conclusions: Aggressive metastasectomy of multi-site CRC is feasible and safe. Despite disease recurrence in the majority of patients there was no significant deterioration of Global HRQoL as a result of treatment. There was a transient effect on symptoms including fatigue, pain dyspnea and role functioning, which improved by 12 months. Clinical trial information: NCT00606398.

ICF, quality of life, and depression in breast cancer: perceived disability in disease-free women 6 months after mastectomy

Aim of the present observational study is to focus on health-related quality of life (HRQL), mood and everyday life of breast cancer affected women disease-free 6 months after mastectomy, paying particular attention to the International Classification of Functioning, Disability and Health (ICF) framework contribution. Sixty-five breast cancer-affected women disease-free 6 months after mastectomy hospitalized for reconstructive surgery (mean age 46.3 ± 7.3) were enrolled. Their depressive symptoms (Beck Depression Inventory-BDI-II), HRQL, and every day life functioning/barriers and facilitators (ICF) were assessed. At the BDI-II, 6 patients (9.2 %) reported mild depression and 6 (9.2 %) severe depression; when the subscales were considered, 7 (10.8%) resulted depressed at the somatic-affective factor and 16 (24.6 %) at the cognitive factor. Compared to normative data no differences emerged at the HRQL Physical Component Summary (46.4 ± 9.3 vs 49.1 ± 10.1), whereas patients reported lower scores at the Mental HRQL Component Summary (45.9 ± 10.1 vs 51.5 ± 9.1; p = 0.00001 t = -4.3). As for the activity and participation domain, 11 of the 42 categories investigated were compromised in at least 20% of the sample: lifting and carrying objects (d430), acquisition of goods and services (d620), doing housework (d640), remunerative employment (d850), and many categories relating to interpersonal relationships; moreover the caregiver seems to be perceived as an important and positive modulator of disability. The addition of the ICF evaluation to the usual psychological assessment gives a more complete picture, enabling a broader perspective of the psychological-clinical implications. Mainly, the women that we have evaluated continue to function in their everyday lives, thanks in part to their ability to accept help from their own families. However, they inevitably carry signs of their disease which some translating into problems with interpersonal relationships, depressive thoughts and negative ideation. Only the synergistic use of all these assessment instruments can one truly perceive all the nuances relating to the social and psychological conditions of the assessed patients' life, overcoming a binomial vision of well-being and ill-being.

Quality of life in a multicenter phase II trial of neoadjuvant full-dose gemcitabine, oxaliplatin, and radiation in patients with resectable or borderline resectable pancreatic adenocarcinoma.

226 Background: Pancreatic cancer remains incurable for the great majority of patients afflicted with the disease. The purpose of this study was to evaluate health related quality of life (HRQoL) following neoadjuvant full dose gemcitabine, oxaliplatin and radiation therapy (30 Gy) for pancreatic adenocarcinoma in a multi-institutional Phase-II trial. Methods: Fifty-seven patients were evaluable for the HRQoL component of this trial that consisted of two cycles of neoadjuvant chemoradiation with gemcitabine and oxaliplatin followed by pancreatectomy and two additional cycles of adjuvant chemotherapy. The effects of therapy on HRQoL were evaluated using: EORTC-C30, EORTC-PAN26 and FACT-HEP. Results: There were 20 patients (35%) with untreated resectable and 37 (65%) with borderline resectable pancreatic cancer. Thirty-nine patients (69%) completed two cycles of preoperative chemotherapy and surgery, 26 (40%) underwent a pancreaticoduodenectomy and 9 (14%) a distal pancreatectomy. Twenty-six patients completed postoperative adjuvant therapy. The median age was 64 (range 42-82); patients younger than 65 had a higher global HRQoL score at 6 months (p=0.046) following the initiation of treatment. There was no difference in the HRQoL according to type of operation performed. EORTC-C30 Global HRQoL remained statistically and clinically unchanged compared to baseline levels at all time-points. FACT-Hep Trial Outcome Index and Total score showed a statistically significant but not clinically meaningful decline following cycle 2 of neoadjuvant treatment (p=0.002 and p=0.004), returning back to baseline levels after 6 months. This may in part be explained by a decrease in the functional (p=0.004) and physical (p=0.001) wellbeing, an increase in diarrhea (p=0.044), digestive symptoms (p=0.037) and an increased fatigue (p&lt;0.001). Conclusions: We report that this neoadjuvant chemoradiation protocol did not have a clinical impact on global HRQoL. Overall this regimen was well tolerated with no negative effect on quality of life following the conclusion of treatment. Clinical trial information: NCT00456599.

Impact of hepatitis B and C co-infection on health-related quality of life in HIV positive individuals

Concurrent infection with HIV, hepatitis B virus (HBV), and hepatitis C virus (HCV) often occurs due to the commonality in risk factors for acquisition. Few studies have examined the effect of co-infection on health-related quality of life (HRQOL) in HIV positive individuals. Ontario HIV Treatment Network Cohort Study (OCS) participants who completed an annual interviewer-administered questionnaire on up to three occasions were included. Generalized estimating equations (GEE) were used to assess the impact of HBV and HCV co-infection on physical and mental HRQOL component summary scores (range 0-100) as measured by the Medical Outcomes SF-36 health survey. As of March 2010, 1,223 participants had completed the questionnaire; 964 were HIV mono-infected, 128 were HIV-HBV co-infected, 112 were HIV-HCV co-infected, and 19 were HIV-HBV-HCV tri-infected. Eighty percent were male, median age 46 (IQR 40-53) years, 61% Caucasian, median CD4 count 464 (IQR 319-636) cells/mm(3), and 74% had undetectable HIV viremia. Physical HRQOL was lower in HIV-HBV and HIV-HCV co-infected individuals (49.4 (IQR 42.0-53.9) and 48.1 (IQR 36.9-52.8) vs. 51.5 (IQR 45.0-55.4); p = 0.01 and <0.0001) compared to mono-infected individuals. In the multivariable GEE model, the negative impact of HCV remained significant (-2.18; p = 0.01) after adjusting for drug use, smoking, age, and gender. Unadjusted mental HRQOL was lower in HIV-HCV co-infected individuals (44.6 (IQR 34.6-54.0) vs. 48.9 (IQR 36.8-55.9); p = 0.03) compared to mono-infected individuals but no association of mental HRQOL with either co-infection was observed in multivariable GEE models. HCV appears to negatively impact physical HRQOL suggesting a greater health burden for co-infected individuals. HBV and HCV co-infections were not related to lower mental HRQOL among people living with HIV/AIDS.

Longitudinal predictors of health-related quality of life in middle-aged and older adults with hypertension

The aim of the study was to assess the longitudinal association between cardiovascular risk factors including albuminuria and other variables (e.g. awareness of hypertension, number of types of antihypertensive drugs, comorbidity), and health-related quality of life (HRQOL) in a large cohort of patients with hypertension, over a follow-up period of 5 years. Nine thousand nine hundred and fifty-three participants of the ESTHER (Epidemiologische Studie zu Chancen der Verhütung, Früherkennung und optimierten Therapie chronischer Erkrankungen) study - a population-based cohort study of middle-aged and older adults aged 50-74 years at baseline - were recruited by general practitioners (GPs) in 2000-2002 and included in the follow-up (2005-2007). HRQOL at baseline and follow-up was measured using the Short-Form General Health Survey (SF-12). Mental component scores (MCS) and physical component scores (PCS) were calculated. Multiple linear regression models were used to determine longitudinal predictors of HRQOL at follow-up. Four thousand, two hundred and three patients with hypertension (98.2%) responded to the SF-12 both at baseline and after 5 years and were therefore included in the study. Smoking status, BMI, diabetes, macroalbuminuria, comorbid diseases, history of depression, and lower HRQOL at baseline predicted lower PCS at the 5-year follow-up. Lower MCS after 5 years was predicted by smoking status, dyslipidaemia, a reported history of depression, and HRQOL at baseline. No significant association was detected between awareness of hypertension and any HRQOL component score after 5 years. Macroalbuminuria and other variables related to increased cardiovascular risk have a negative impact on PCS. Suggestions of a link of treatment and awareness of hypertension with HRQOL from previous cross-sectional studies are not supported by our longitudinal findings.