Global Quality Of Life Measures Research Articles

Peer-mentor support for older vulnerable myocardial infarction patients referred to cardiac rehabilitation: single-arm feasibility study

BackgroundThe positive effects of cardiac rehabilitation are well established. However, it has an inherent challenge, namely the low attendance rate among older vulnerable patients, which illustrates the need for effective interventions. Peer mentoring is a low-cost intervention that has the potential to improve cardiac rehabilitation attendance and improve physical and psychological outcomes among older patients. The aim of this study was to test the feasibility and acceptability of a peer-mentor intervention among older vulnerable myocardial infarction patients referred to cardiac rehabilitation.MethodsThe study was conducted as a single-arm feasibility study and designed as a mixed methods intervention study. Patients admitted to a university hospital in Denmark between September 2020 and December 2020 received a 24-week peer-mentor intervention. The feasibility of the intervention was evaluated based on five criteria by Orsmond and Cohn: (a) recruitment capability, (b) data-collection procedures, (c) intervention acceptability, (d) available resources, and (e) participant responses to the intervention. Data were collected through self-administrated questionnaires, closed-ended telephone interviews, semi-structured interviews, and document sheets.ResultsTwenty patients were offered the peer-mentor intervention. The intervention proved feasible, with a low dropout rate and high acceptability. However, the original inclusion criteria only involved vulnerable women, and this proved not to be feasible, and were therefore revised to also include vulnerable male patients. Peer mentors (n = 17) were monitored during the intervention period, and the findings indicate that their mentoring role did not cause any harm. The peer-mentor intervention showed signs of effectiveness, as a high rate of cardiac rehabilitation attendance was achieved among patients. Quality of life also increased among patients. This was the case for emotional, physical, and global quality of life measures at 24-week follow-up.ConclusionThe peer-mentor intervention is a feasible and acceptable intervention that holds the potential to increase both cardiac rehabilitation attendance and quality of life in older vulnerable patients. This finding paves the way for peer-mentor interventions to be tested in randomized controlled trials, with a view toward reducing inequality in cardiac rehabilitation attendance. However, some of the original study procedures were not feasible, and as such was revised.Trial registrationThe feasibility study was registered at ClinicalTrials.gov (ClinicalTrials.gov identification number: NCT04507529), August 11, 2020.

Psychometric properties of the Urdu version of the EORTC QLQ-H&N35 (European organization for research and treatment of cancer head and neck module) quality of life tool

BackgroundWe translated and validated the Urdu version of the European Organization for Research and Treatment of Cancer Quality of Life (QoL) Questionnaire’s Head and Neck (H&N) Cancer Module (EORTC QLQ-H&N35) and assessed its convergent and discriminant validity by examining correlations of QoL with depression, anxiety, and resilience.MethodsWe translated the EORTC QLQ-H&N35 according to EORTC instructions. Patients at a tertiary care hospital in Pakistan completed a survey consisting of Urdu versions of EORTC QLQ-C30 (core QoL tool), QLQ-H&N35, Hospital Anxiety and Depression Scale, and Wagnild and Young Resilience Scale (RS-14). Content validity, convergent validity, discriminant validity, and reliability (using Cronbach’s alpha) of the EORTC QLQ-H&N35 were assessed.ResultsOur sample comprised 250 patients with H&N cancer, most commonly oral (82%). The Urdu translations were comprehensible for all patients. The Cronbach alpha for QLQ-H&N35 multi-item domains ranged from 0.75 to 0.98 (acceptable to excellent), barring “Senses Problems”, which was less than the generally acceptable level (0.50). The patient-reported content validity index (CVI) scores for relevance and clarity of the Urdu version of the QLQ-H&N35 were 0.93 and 0.92, respectively (both excellent). Our results revealed weak bidirectional correlations of the QLQ-H&N35 with resilience, depression, and anxiety, showing good discriminant validity. A weak-to-moderate but significant negative correlation (r: − 0.185 to − 0.613; p < 0.01) was seen between the QLQ-H&N35 and the global QoL measure of the QLQ-30.ConclusionOur Urdu translation of the EORTC QLQ-H&N35 demonstrated validity comparable to previous studies, with good discriminant construct validity when measured against resilience, depression, and anxiety. An issue of concern is the poor internal consistency of the “Senses Problems” domain. Nevertheless, the Urdu translation produced in this study serves as a valid and reliable measure to measure QoL in H&N cancer in clinical or research settings in Pakistan.

Sexual quality of life assessment in young women with breast cancer during adjuvant endocrine therapy and patient-reported supportive measures

PurposeSexual quality of life (QoL) is affected during and after breast cancer (BC) treatment. The purpose was to investigate sexual and global QoL and patient-reported measures to address this issue in young women (< 51 years) with BC after the acute treatment phase, during adjuvant endocrine therapy.MethodsThree EORTC questionnaires and an additional specific questionnaire, developed for the study, were used to assess sexual and global QoL and patient-reported supportive measures in BC patients who had received their endocrine therapy for at least 24 months. Among the 54 eligible patients, 45 (83%) agreed to participate in the study.ResultsWe showed a deterioration in sexual QoL and poor communication with healthcare professionals. Most patients (88.9%) declared that it was important that sexuality should be discussed with caregivers and that the partner should also be involved. Most patients (60%) had taken at least one action to overcome their sexual problems. Most of these interventions (63%) originated from the patient herself.ConclusionsSexual QoL is a major issue in young BC patients and is poorly addressed by healthcare professionals. Most of the supportive methods used by the patients to overcome these side effects were on their own initiative. Communication and counseling on sexuality by healthcare professionals need to be improved during BC treatment. Patients suggested supportive measures they would find useful and appropriate to develop in the clinic. The final goal is to improve the sexual QoL of BC patients with the appropriate intervention and support.

Abstract 11672: Limited Improvement in Global Quality of Life Measures After TAVR

Introduction: Transcatheter aortic valve replacement (TAVR) is now the preferred treatment for older adults with symptomatic aortic stenosis (AS). While the goal is often symptom improvement, quality of life (QOL) may be adversely impacted by non-cardiac conditions. We evaluated changes in the global QOL Patient-Reported Outcomes Measurement Information System (PROMIS) Physical survey after TAVR. Methods: Single-center prospective study of 204 patients undergoing TAVR from 10/2019 to 6/2021. Subjects completed The Kansas City Cardiomyopathy Questionnaire (KCCQ) and PROMIS Physical surveys pre-TAVR and 30 days post-TAVR, of whom 85 (42%) had complete data on disease-specific and global QOL. A clinically meaningful change in PROMIS was defined as &gt; 5 points. Good disease specific QOL was defined as KCCQ &gt; 75. The correlation between KCCQ and PROMIS was assessed. Results: The mean age was 78.9 years and 47% identified as female. The mean pre-TAVR PROMIS Physical and KCCQ scores were 42 (SD 9.4) and 62.6 (SD 22.4), respectively. 30-days post TAVR, the average change in KCCQ was +23.0 (SD 24.9), while the average change in PROMIS Physical score was +3.9 (SD 8.8). There was modest correlation between post-procedure disease-specific and global QOL scores ( Figure 1 , R 2 0.48, p &lt;0.001). At 30 days post-procedure, 69 patients (81.2%) reported good disease-specific QOL, while 36 (42.4%) had a clinically meaningful improvement in global QOL. Of patients with improvement in KCCQ, 33 (47.8%) reported a meaningful improvement in global QOL. Conclusions: The majority of patients report good disease-specific QOL after TAVR; however, less than ½ of TAVR treated patients have a clinically meaningful increase in global QOL at 30 days. There is modest correlation between disease-specific (KCCQ) and global (PROMIS) QOL scores following TAVR. Improvement in QOL after TAVR may be limited by conditions unrelated to AS.

Socio-economic status of women and fertility outcome in Benue State, North-Central, Nigeria

Nigeria still records high fertility despite launching programs to reduce fertility rate. We therefore surveyed the influence of socio-economic status of women on their fertility outcome in Benue State, North-Central, Nigeria. Data from 1049 childbearing women were collected using questionnaires. The data were analyzed using logistic regression and chi-square statistics. Significant relationship exists between education, income, occupation, age, marital status and fertility outcome at p < .05. To achieve global health development and be amongst the best performers in global quality of life measures, women’s empowerment programs are encouraged to enhance their autonomy in decision making with reference to reproduction.

Health-related quality of life and psychosocial implications in testicular cancer survivors. A literature review.

In this review, we focused our attention on Quality of Life (QoL) of testicular cancer survivors (TCSs), in general and in the most relevant areas. Several key findings have been highlighted in our review. PubMed, MEDLINE and PsycINFO databases were consulted to find published studies, from 1980 to May 2017, that met our inclusion criteria. The majority of studies investigated older adult TCSs, while few studies on adolescent and young adult patients were available. Many studies indicate that health-related QoL (HRQoL) is similar among the TCSs and the general population. Even if QoL deteriorates so clear at the time of diagnosis and throughout treatment, afterward returns to normal levels, as defined by the matched controls. However, there are numerous chronic conditions consequent to diagnosis and treatment of testicular cancer that plague survivors and affect QoL, like Raynaud-like phenomena, peripheral neuropathy, fatigue, anxiety, sexual, fertility and body image problems. Even if these problems can have no effects on the measures of global QoL, they have an impact on the quality of life. Differences between TCSs with and without a partner bring to different outcomes in the adjustments to cancer. It is necessary to identify TCSs with higher risks of poorer QoL outcomes, to focus interventions on the areas with the greatest impairments. Further researches should consider the effects of testicular cancer on the impaired areas, collecting more data to better identify survivor's needs and consequent interventions, with a special focus on adolescent and young adult TCSs. Other works are requested on therapies, preventive and ameliorative, to reduce chronic side effects of testicular cancer treatment.

Treatment of selective mutism: a 5-year follow-up study

Selective mutism (SM) has been defined as an anxiety disorder in the diagnostic and statistical manual of mental disorders (DSM-5). Cognitive behavioral therapy (CBT) is the recommended approach for SM, but prospective long-term outcome studies are lacking. Reports from the children themselves, and the use of more global quality of life measures, are also missing in the literature. We have developed a school-based CBT intervention previously found to increase speech in a pilot efficacy study and a randomized controlled treatment study. Continued progress was found in our 1-year follow-up studies, where older age and more severe SM had a significant negative effect upon outcome. In the present study, we provide 5-year outcome data for 30 of these 32 children with SM who completed the same CBT for mean 21 weeks (sd 5, range 8–24) at mean age 6 years (10 boys). Mean age at the 5-year follow-up was 11 years (range 8–14). Outcome measures were diagnostic status, the teacher- and parent-rated selective mutism questionnaires, and child rated quality of life and speaking behavior. At the 5-year follow-up, 21 children were in full remission, five were in partial remission and four fulfilled diagnostic criteria for SM. Seven children (23%) fulfilled criteria for social phobia, and separation anxiety disorder, specific phobia and/or enuresis nocturna were found in a total of five children (17%). Older age and severity at baseline and familial SM were significant negative predictors of outcome. Treatment gains were maintained on the teacher- and parent questionnaires. The children rated their overall quality of life as good. Although most of them talked outside of home, 50% still experienced it as somewhat challenging. These results point to the long-term effectiveness of CBT for SM, but also highlight the need to develop more effective interventions for the subset of children with persistent symptoms.Clinical trials registration NCT01002196

Impact of Sleep-Disordered Breathing Treatment on Quality of Life Measures in a Large Clinic-Based Cohort.

This study aims to report the effect of positive airway pressure (PAP) therapy on quality of life (QoL) measures in the clinical sleep-disordered breathing (SDB) population. We examined general QoL measures assessed by European Quality of Life-5D (EQ-5D) and sleep-specific QoL by examining Functional Outcomes of Sleep Questionnaire (FOSQ) scores before and after PAP therapy retrospectively in a clinical SDB population using paired and two-sample t tests. Age and socioeconomic status (SES) effect modification on pre-PAP QoL measures were investigated utilizing the interaction terms. A total of 2,027 patients with SDB initiated PAP therapy between January 1, 2010 and December 31, 2014. The mean age of the cohort was 56.2 years (standard deviation = 13.2), with 45.8% female and 76.9% Caucasians. EQ-5D change after exclusion of those with normal QoL was 0.042 (0.152) in all patients, 0.051 (0.150) in patients who were PAP adherent by self-report, and 0.050 (0.132) in patients who were objectively PAP adherent (n = 704 of 1,011 with available objective adherence data, 69.6%). Change in FOSQ after excluding those with normal FOSQ was 1.9 (2.9) in all patients, 2.2 (2.9) in patients who were PAP adherent by self-report, and 2.3 (2.9) in patients who were objectively PAP adherent. Those with (1) worse QoL at baseline and younger age and (2) worse QoL at baseline and residing in lower SES strata had worse outcomes after PAP therapy (P < .05). We found consistent improvement in global and sleep-specific QoL measures after PAP therapy, hence providing evidence of PAP benefit in the clinical population and rationale for targeted efforts to optimize QoL in younger and lower SES subgroups.

Prophylactic cranial irradiation (PCI) versus observation in radically treated stage III non-small cell lung cancer (NSCLC): A randomized phase III NVALT11 study.

8502 Background: Brain metastases are one of the major sites of tumor failure in patients (pts) with radically treated stage III NSCLC. The value of PCI in these pts remains unsettled. This study is designed to investigate whether PCI reduces the incidence of symptomatic brain metastases (sBM). Methods: Pts were randomized between observation and PCI after concurrent or sequential chemo-RT with or without surgery. PCI dose was left to the physician(36 Gy/18F, 30 Gy/12F, 30 Gy/10F). Pts were registered before randomization, those progressing after chemo-RT were not randomized. Pts were followed for sBM (defined as increased intracranial pressure, headache, nausea, vomiting, cognitive, affective disturbances, seizures, focal neurological symptoms andMRI/CT), side effects, survival, quality of life (QLQ-C30, EuroQol 5D). The primary endpoint is the proportion of patients developing sBM. Randomizing 300 pts the study has 90% (2-sided p = 0.05) power to detect 17% decrease in pts developing sBM at 24 months (mo). Results: Between 2009 and 2015, 195 pts were registered, 175 were randomized, 87 received PCI and 88 pts were in the observation arm. In 2013 due to slow accrual, it was decided to reduce the number of randomized pts to 175 pts. With 75 events a 2-sided log-rank test would have 80% power to detect HR 0.52 and alpha 0.05. One pt in PCI arm was withdrawn after randomization. Pts characteristics were male (n = 114, 66%); adeno/squa/other 72 (41%), 62 (36%), 40 (23%); PS 0/1/2 66 (38%), 99 (57%), 9 (5%); stage IIIA/B 93 (53%), 80 (46%), unknown 1 (1%). Median follow up was 48.5 mo (95% CI, 39 - 54). Proportion of pts with sBM was 4/86 (4.6%) in PCI and 25/88 (28.4 %) in observation (p &lt; 0.00001). Seven (8.1%) pts in PCI and 26 (29.7%) pts in observation arm had BM on imaging (p &lt; 0.001). Median time to sBM was not reached in either arm. Median OS was 24.2 mo in PCI and 21.9 mo in observation arm (p = 0.52). Global QoL at 3 mo was worse in PCI arm (p = 0.02) but not afterwards. Conclusions: PCI significantly decreases the proportion of patients developing both symptomatic BM without influencing overall survival. PCI decreases 3 months global quality of life measures but not beyond. Clinical trial information: NTR 1601.

Validating the generic quality of life tool "QOL10" in a substance use disorder treatment cohort exposes a unique social construct.

BackgroundGeneric quality of life (QoL) instruments provide important measures of self-reported wellbeing that can be compared across healthy and clinical populations. The aim of this analysis is to validate the ten-item QoL instrument “QOL10”, as well as to confirm the validity of the embedded “QOL5” questionnaire and single-item “QOL1” in measuring overall QoL among adults in a substance use disorder treatment study.MethodsWe used exploratory factor analysis and measured internal and convergent validity of the QOL10 against the gold standard measure of the WHOQOL-BREF, in a subsample of 107 participants in a substance use disorder treatment study.ResultsThe QOL10 displayed internal and convergent validity to the gold standard measure. Factor analysis revealed a two-factor structure that can be interpreted as “social QoL”, containing items about relationships and social functioning, and “global QoL”, comprised of items about health, working ability, self-evaluation, and an overall QoL estimation.ConclusionsThe QOL10 provides clinically useful and valid measures of social-related QoL and global QoL via two subscales. Interestingly, the QOL10’s social QoL measure, from the current sample, had little relationship to the analyzed groups previously reported to have differential global QoL: social QoL appears to be not only conceptually distinct from global QoL, but also to be less influenced by typical substance- and treatment-specific factors.

Dispositional optimism and terminal decline in global quality of life.

We examined whether dispositional optimism relates to change in global quality of life (QOL) as a function of either chronological age or years to impending death. We used a sample of 2,096 deceased postmenopausal women from the Women's Health Initiative clinical trials who were enrolled in the 2005-2010 Extension Study and for whom at least 1 global QOL and optimism measure were analyzed. Growth curve models were examined. Competing models were contrasted using model fit criteria. On average, levels of global QOL decreased with both higher age and closer proximity to death (e.g., M(score) = 7.7 eight years prior to death vs. M(score) = 6.1 one year prior to death). A decline in global QOL was better modeled as a function of distance to death (DtD) than as a function of chronological age (Bayesian information criterion [BIC](DtD) = 22,964.8 vs. BIC(age) = 23,322.6). Optimism was a significant correlate of both linear (estimate(DtD) = -0.01, SE(DtD) = 0.005; ρ = 0.004) and quadratic (estimate(DtD) = -0.006, SE(DtD) = 0.002; ρ = 0.004) terminal decline in global QOL so that death-related decline in global QOL was steeper among those with a high level of optimism than those with a low level of optimism. We found that dispositional optimism helps to maintain positive psychological perspective in the face of age-related decline. Optimists maintain higher QOL compared with pessimists when death-related trajectories were considered; however, the gap between those with high optimism and those with low optimism progressively attenuated with closer proximity to death, to the point that is became nonsignificant at the time of death.

Testing reliability and validity of oral impacts on daily performances for Chinese-speaking elderly Singaporeans.

To cross-culturally adapt the oral impacts on daily performance (OIDP) and assess its reliability and validity on Chinese-speaking community dwelling elderly Singaporeans. There are no previous reports of valid oral health-related quality of life instruments for elderly Singaporeans or perceived conditions associated with impacts reported in OIDP among the Singaporean elders. The OIDP was translated from English to Chinese and then back translated. The OIDP questionnaire along with questions related to overall quality of life and self-rated dental health was administered to 202 Chinese-speaking elderly Singaporeans by trained interviewers, and it was repeated after 1month. Test-retest reliability was assessed using intraclass correlation coefficient; internal consistency was established using Cronbach's alpha, and construct validity using correlation coefficients with self-reported oral health-related and global quality of life measures. In addition, Kruskal-Wallis tests assessed differences in the OIDP score between different subjective health and global quality of life groups. The median age of participants was 75years. About 19% reported oral impacts and difficulty eating was the most prevalent oral impact. Internal consistency was good with a Cronbach's alpha of 0.75, and the intraclass correlation coefficient was 0.75 (0.67-0.81). OIDP was significantly correlated with all measures of self-reported oral health and global ratings of quality of life, with correlation coefficients ranging between 0.15 and 0.52. Groups with worse perceptions about their health and quality of life had significantly higher OIDP scores. The OIDP showed successful reliability and validity for its use among Chinese-speaking older Singaporeans.

Sexuality and Sexual Pleasure After Sexual Assault

Sexual dysfunction represents a complex and multifactorial construct that can affect both men and women and has been noted to often deteriorate significantly after treatment for rectal and anal cancer. Despite this, it remains an understudied, underreported, and undertreated issue in the field of cancer survivorship.This study examined the characteristics of women enrolled in an intervention trial to treat sexual dysfunction, and explored the relationship between sexual functioning and psychological well‐being.There were 70 female posttreatment anal or rectal cancer survivors assessed as part of the current study. Participants were enrolled in a randomized intervention trial to treat sexual dysfunction and completed outcome measures prior to randomization.The main outcome measures are quality of life (QOL) (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC‐QLQ‐C30] and Colorectal Cancer‐Specific Module [QLQ‐CR38]), sexual functioning (Female Sexual Functioning Index), and psychological well‐being (Brief Symptom Inventory Depression/Anxiety, Impact of Events Scale‐Revised, CR‐38 Body Image).Women enrolled in the study intervention were on average 55 years old, predominantly Caucasian (79%), married (57%), and a median of 4 years postprimary treatment. For those reporting sexual activity at baseline (N = 41), sexual dysfunction was associated with a range of specific measures of psychological well‐being, all in the hypothesized direction. The Sexual/Relationship Satisfaction subscale was associated with all measures of psychological well‐being (r = −0.45 to −0.70, all P < 0.01). Body image, anxiety, and cancer‐specific posttraumatic distress were notable in their association with subscales of sexual functioning, while a global QOL measure was largely unrelated.For sexually active female rectal and anal cancer survivors enrolled in a sexual health intervention, sexual dysfunction was significantly and consistently associated with specific measures of psychological well‐being, most notably Sexual/Relationship Satisfaction. These results suggest that sexual functioning may require focused assessment by providers, beyond broad QOL assessments, and that attention to Sexual/Relationship Satisfaction may be critical in the development and implementation of interventions for this cohort of patients. Philip EJ, Nelson C, Temple L, Carter J, Schover L, Jennings S, Jandorf L, Starr T, Baser R, and DuHamel K. Psychological correlates of sexual dysfunction in female rectal and anal cancer survivors: Analysis of baseline intervention data. J Sex Med 2013;10:2539–2548.

Psychological Correlates of Sexual Dysfunction in Female Rectal and Anal Cancer Survivors: Analysis of Baseline Intervention Data

Sexual dysfunction represents a complex and multifactorial construct that can affect both men and women and has been noted to often deteriorate significantly after treatment for rectal and anal cancer. Despite this, it remains an understudied, underreported, and undertreated issue in the field of cancer survivorship. This study examined the characteristics of women enrolled in an intervention trial to treat sexual dysfunction, and explored the relationship between sexual functioning and psychological well-being. There were 70 female posttreatment anal or rectal cancer survivors assessed as part of the current study. Participants were enrolled in a randomized intervention trial to treat sexual dysfunction and completed outcome measures prior to randomization. The main outcome measures are quality of life (QOL) (European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC-QLQ-C30] and Colorectal Cancer-Specific Module [QLQ-CR38]), sexual functioning (Female Sexual Functioning Index), and psychological well-being (Brief Symptom Inventory Depression/Anxiety, Impact of Events Scale-Revised, CR-38 Body Image). Women enrolled in the study intervention were on average 55 years old, predominantly Caucasian (79%), married (57%), and a median of 4 years postprimary treatment. For those reporting sexual activity at baseline (N=41), sexual dysfunction was associated with a range of specific measures of psychological well-being, all in the hypothesized direction. The Sexual/Relationship Satisfaction subscale was associated with all measures of psychological well-being (r=-0.45 to -0.70, all P<0.01). Body image, anxiety, and cancer-specific posttraumatic distress were notable in their association with subscales of sexual functioning, while a global QOL measure was largely unrelated. For sexually active female rectal and anal cancer survivors enrolled in a sexual health intervention, sexual dysfunction was significantly and consistently associated with specific measures of psychological well-being, most notably Sexual/Relationship Satisfaction. These results suggest that sexual functioning may require focused assessment by providers, beyond broad QOL assessments, and that attention to Sexual/Relationship Satisfaction may be critical in the development and implementation of interventions for this cohort of patients.

Predictors of health-related and global quality of life among young adults with difficult-to-treat epilepsy and mild intellectual disability

ObjectiveThis study evaluated predictors of health-related quality of life (HRQOL) and global quality of life (QOL) among young adults with difficult-to-treat epilepsy and mild intellectual disability. MethodsOne hundred and forty-two persons with epilepsy and cognitive problems were routinely screened on HRQOL, global QOL, and psychological distress four weeks after admission to a time-limited residential rehabilitation unit. The PESOS scales (PE = PErformance, SO = SOciodemographic aspects, S = Subjective evaluation/estimation) on epilepsy-specific problems were administered as measures of HRQOL; a questionnaire on life satisfaction and an item on overall QOL were used as measures of global QOL. Psychological distress was captured with the Symptom Checklist 90-R. Further data were gained from medical files. Quality-of- life predictors were identified using univariate methods and stepwise regression analyses. ResultsPsychological distress was the only predictor of all HRQOL and global QOL parameters. Seizure frequency was a predictor of most HRQOL variables. Other epilepsy variables affected only some HRQOL variables but were not associated with global QOL. Health-related quality of life did not seem to be strongly impaired. Only low correlations were found between HRQOL and global QOL. ConclusionThe notion of psychological distress as the most influential predictor of all QOL measures is in line with most findings on QOL in epilepsy. Former observations of weak associations between HRQOL and global QOL among patients with epilepsy and mild intellectual disability are supported. Thus, interventions to reduce psychological distress, besides epilepsy treatment, seem to be of great importance to improve QOL.

Intermittent high-dose intravenous interferon alpha 2b (IFNa2b) for adjuvant treatment of stage III malignant melanoma: Final analysis of a randomized phase III DeCOG-trial (NCT00226408).

8505 Background: Adjuvant high-dose interferon (HDI) treatment of patients (pts) with malignant melanoma (MM) usually consists of 4 weeks initial intravenous (iv) infusion of 20 MU/m² IFNa2b followed by 11 months of 10 MU/m² subcutaneously (sc). It is still unclear, whether both components are necessary for the efficacy of HDI in high-risk MM pts. The adjuvant phase III DeCOG MM-ADJ-5 trial evaluates efficacy, safety, tolerability and quality of life (QoL) of an intermittent (pulsed) high-dose iv IFNa2b regimen as compared to standard HDI. Methods: Patients with stage III (AJCC 2002) resected intransit or lymph node metastasis from cutaneous malignant melanoma were randomly assigned to receive either standard HDI regimen (Arm A), or 3 courses of IFNa2b 20 MU/m² iv on 5 days a week for 4 weeks repeated every 4 months (Arm B). Distant metastasis free survival (DMFS) was the primary endpoint for efficacy analysis. The EORTC QLQ C30 questionnaire was used before and during the study in a standardized way (weeks 0, 4, 16, 24, 40). In addition, patients completed a diary containing global QoL measures every week. Results: Out of 649 patients who were enrolled, 22 patients had to be excluded from the intent-to-treat analysis. The remaining 627 patients were well balanced between both arms according to sex, age, and stage. Median follow-up was similar in both groups (55.4 vs. 55.3 months). Distant metastasis occurred in 138 (Arm A; 44%) vs. 145 (Arm B; 47%) patients without statistical significance (p=0.46). Survival was not significantly different for DMFS (HR 1.1; p=0.39) or OS (HR=1.0; p=0.85). Termination of treatment due to adverse events or QoL related reasons occurred significantly more often in arm A than in arm B (26.0% vs. 14.8%; p&lt;0.001). The pulsed schedule resulted in less cumulative toxicity as compared to the standard regimen, in particular regarding fatigue and neuropsychiatric side effects. Conclusions: The final analysis of pulsed adjuvant HDI treatment showed no significant DMFS or OS differences in comparison to conventional HDI. There is a clearly favorable safety and QoL profile of the pulsed regimen.

Application of the WHOQOL-100 for the assessment of quality of life of adult patients with inherited metabolic diseases

BackgroundAs advances in neonatal and pediatric care for patients affected by inherited metabolic diseases (IMD) improve their outcome and allow for better survival rates, there is a growing interest in the quality of life (QoL) of patients reaching adulthood. In order to address this subject we designed a study to evaluate the QoL of a group of adult IMD patients who are receiving various treatments, in a comprehensive manner. MethodsA mixed-method study was conducted to assess the QoL in adult IMD patients. The multidimensional World Health Organization Quality of Life questionnaire (WHOQOL-100) was applied for quantitative evaluations, and an additional semi-standardized interview, was conducted for qualitative measurement of patients' perceptions of the impact of illness on their daily life, and the perceived adherence to their treatment recommendations. A total of 82 patients affected by IMD were enrolled. The inherited metabolic disorders included principally amino acids disorders, urea cycle defects, organic acidurias, carbohydrates disorders, and lysosomal disorders. The WHOQOL-100 and the semi-standardized interview were administered in a clinical setting to adult patients with IMD. ResultsThe mean for the whole group indicates that adult patients with IMD can have a normal value of General QoL. Despite this value, the results of each domain show lower scores in the domains of perception of independence and quality of social relationships. We made a further analysis to compare the patients with dietary treatment with the patients with pharmacological treatment, and we observed a statistically significant difference in General QoL, in the Physical, Independence, Spiritual domains and in the facet of Medication.These results suggest that Global QoL measures might not be sufficient to assess the QoL for adult patients with IMD. Furthermore, the implementation of a qualitative semi-standardized interview, especially suitable for adult patients, added important features on illness perception and on perceived adherence to the treatment by adult IMD patients. ConclusionIn this study we underlined the importance of applying multidimensional instruments, like WHOQOL-100, to evaluate the quality of life of adult patients with IMD. The WHOQOL-100 has been demonstrated to be a valid instrument to measure the QoL of IMD patients.Moreover, the administration of a tailored psychometric instrument in combination with a qualitative interview may help us to better characterize special issues related to IMD. Indeed, other factors beyond the physical manifestations of the disease, such as psychological wellbeing, social behavior, illness perception and adherence to the treatment, strongly influence QoL and may serve as valid targets for intervention to improve patients' care. We believe this kind of approach is especially useful for adult patients with inherited metabolic diseases.

Issues in Evaluating Importance Weighting in Quality of Life Measures

For most empirical research investigating the topic of importance weighting in quality of life (QoL) measures, the prevailing approach has been to use (1) a limited choice of global QoL measures as criterion variables (often a single one) to determine the performance of importance weighting, (2) a limited option of weighting methods to develop importance weighting, and (3) a limited number of domains to construct the (formative-indicator) measures. Although limitations resulted from a limited choice of global QoL measures as criterion variables to determine the performance of importance weighting and a limited option of weighting methods to develop importance weighting have been recognized previously, little attention has been paid to the impact of non-comprehensive domains in QoL measures constructed based on the formative-indicator approach. Using empirical data, this article revealed the potential impacts of non-comprehensive domains on the evaluation of importance weighting in QoL measures. Results presented in this article showed that both of the two most popular methods of evaluating the performance of importance weighting in QoL measures, correlation and moderated regression analysis, could produce misleading results in the situation when QoL measures constructed using the formative-indicator approach did not include comprehensive domains. Issues discussed in this article are of great importance to research in the field of QoL, especially on the topic of importance weighting in QoL measures.

Importance is Not Unimportant: The Role of Importance Weighting in QOL Measures

The effect of relative domain importance as a weighting mechanism in quality of life (QoL) measures has been a topic of debate for decades. Studies investigating the role of domain importance in QoL measures have produced mixed results. The mixed results may very well be the consequences of a limited choice of global satisfaction or QoL measures, measurements of domain satisfaction, measurements of domain importance and weighting approaches applied to date. This study investigated the effect of importance weighting without assigning any arbitrary weighting function of domain importance. A cluster analysis was first used to classify individuals into groups, based on their perceived importance of various life domains, and then the relationship between global life satisfaction measure and the composite of domain satisfaction scores between these groups was compared. Results of this study showed that the relationship between global life satisfaction and composite of satisfaction scores did not remain consistent for respondents with different importance rankings of major life domains, which suggested an important effect of domain importance in QoL measures.

Should We Give Up Domain Importance Weighting in QoL Measures?

The purpose of this article is to examine the recent claims calling for abolishing domain importance weighting in quality of life (QoL) measures by considering the evidence conceptually and empirically. Based on a close review of evidence presented to date, it is suggested that using the range-of-affect hypothesis as a possible explanation of the poor performance of weighted satisfaction composite in predicting or correlating with global satisfaction or QoL measures can be beneficial to our understanding of the life satisfaction literature. However, given the conceptual focus and the empirical approach of the range-of-affect hypothesis presented in the life satisfaction context, using the range-of-affect hypothesis to argue against domain importance weighting raised more questions than answers. Calling for abolishing domain importance weighting in QoL measures, based on the evidence of range-of-affect hypothesis, is premature.