Introduction: Recurrent Clostridium difficile infection (rCDI) is an urgent public health threat that is associated with significant mortality, substantial medical costs, and decreased quality of ...life. Microbiota therapy is gaining acceptance to prevent rCDI in multi-recurrent patients. RBX2660, a standardized microbiome-based therapeutic, was previously reported to show efficacy in rCDI prevention in a ran-domized, double-blind, placebo-controlled Phase 2B clinical study (PUNCH CD2). Herein, we evaluated this Phase 2B study data to determine how quality of life (QoL) assessment was associated with RBX2660 treatment. Methods: Subjects enrolled in the double-blinded, placebo-controlled multi-center Phase 2B clinical study were randomized to receive either 2 RBX2660 doses (Group A), 2 placebo doses (Group B) or 1 RBX2660 dose + 1 placebo dose (Group C) via enema, with doses delivered 7 days apart. Enrolled subjects had >2 prior rCDI or >2 prior CDI episodes requiring hospitalization. The primary efficacy endpoint was absence of CDI at 8 weeks from the last dose. The validated SF-36 was used to identify changes to health-related QoL following study treatment. QoL was assessed at Baseline and at weeks 1, 4 and 8 following blinded treatment, and were compared within and across treatments using unpaired t-test. Each component is analyzed on a 0-100 scale with a higher score representing an increase to QoL. Results: The Baseline results for the mean Physical Component Score (PCS) and Mental Component Score (MCS) were comparable across arms, and there were no statistically significant differences at base-line between subjects who later responded to treatment and those who did not. By week 1, statistically significant and clinically important differences were noted for the MCS within each group compared to Baseline scores and were maintained through 8 weeks. Overall, both the mean PCS and MCS improved after treatment across all groups. There were no significant differences identified between treatment groups. Conclusion: The similarity among Baseline SF-36 QoL scores confirms a uniform population among treatment groups. The statistically significant SF-36 increase after treatment underscores the potential QoL benefit for preventing rCDI, even as early as one week after treatment. Larger studies will be needed to confirm these results and to detect a significant difference in QoL scores between RBX2660- and placebo-treated participants.
This study aimed to assess the health‐related quality of life and identify its associated factors in women with endometriosis. A cross‐sectional correlation study design and convenience sampling were ...conducted in the gynecological outpatient clinic of a teaching hospital in northern Taiwan. A total of 216 women with endometriosis were recruited. The data were collected using structured questionnaires and analyzed using descriptive and inferential statistics. Participants reported a moderate level of health‐related quality of life. The most significant impact of endometriosis on health‐related quality of life was emotional well‐being, followed by feeling of control or powerless, pain, social support, and self‐image. Educational attainment, menstrual cycle, period length, perceived menstrual flow, symptom distress, and self‐management strategies explained 66% of the variance in health‐related quality of life. Factors influencing health‐related quality of life in women with endometriosis play a key role in promoting women's well‐being. Interventions based on these related factors should be developed and taken into practice to effectively manage the disease‐related symptoms for women with endometriosis and thereby improve their overall health‐related quality of life.
Purpose
To describe health status and health state utilities measured by the EQ-5D-3L in a population-based sample of individuals aged 85 + in Germany, and to analyze associations with basic ...socio-demographic variables.
Methods
Cross-sectional data from follow-up wave 7 (
n
= 761) of the German AgeCoDe Study were used. The EQ-5D-3L questionnaire was used to record problems in five health dimensions, its visual analogue scale (EQ VAS) was used to record self-rated health status, and the German EQ-5D-3L index was used to derive health state utilities.
Results
Mean age of respondents was 88.9 years (SD 2.9; range 85 to 100), 67.4% were female. 81.9% reported problems in at least one of the EQ-5D dimensions, with 15.3% reporting extreme problems. Most frequent were problems with pain/discomfort (64.8%), followed by mobility (62.5%), usual activities (42.6%), self-care (28.2%), and anxiety/depression (20.5%). Mean EQ VAS score was 62.4 (SD 18.8), and mean EQ-5D index was 0.77 (SD 0.24). Multiple regression analysis showed associations of problem frequency in various EQ-5D dimensions with age, gender, living situation, marital status, and education. The EQ VAS score was negatively associated with age (
β
= − 0.56;
p
< 0.05) and female gender (
β
= − 3.49;
p
< 0.05). The EQ-5D index was negatively associated with not living in the community (
β
= − 0.10;
p
< 0.001) and being single (
β
= − 0.09;
p
< 0.05).
Conclusions
The results show a substantially impaired health status of the oldest-old population. The data can be used for comparing health status of population groups as well as for health economic models.
Past research has supported the utility of the Double ABCX model of family adaptation for parents raising a child with autism spectrum disorder (ASD). What remains unclear is the impact of ...family-related variables on outcomes in both mothers and fathers within the same family. We explored the potential predictors of maternal and paternal stress and family quality of life in an Australian sample of 196 parents of children with ASD aged 3–16 years. Using a cross-sectional design, parents completed questionnaires assessing factors within the Double ABCX model attributed to family adaptation. Findings provide further evidence of the negative impact of child externalising behaviours and highlight the importance of family sense of coherence on positive parental outcomes.
Background and Objective
Patient‐centered assessments are particularly important in periodontal treatment in which their concerns may differ from the traditional clinical endpoints. However, ...information is limited regarding the influence of periodontal surgery on patients' quality of life (QoL). The aim of the present study was to investigate the impact of surgical periodontal therapy on the oral health‐related QoL of patients who have received initial periodontal therapy.
Methods
A three‐center prospective clinical study design was used, with the study participants comprising patients with moderate to severe periodontitis. Following initial periodontal therapy, the participants received either surgical or non‐surgical periodontal treatment. The Oral Health‐related Quality of Life Model for Dental Hygiene (OHRQL instrument), was used to assess participants' oral health‐related QoL at each periodontal assessment interval: baseline (phase I), after initial therapy (phase II) and after surgery or during supportive periodontal therapy (phase III).
Results
Seventy‐six patients (26 non‐surgery, 50 surgery) completed the third phase of OHRQL assessment and were subjected to data analysis. From phase II to III, an improvement was achieved in all clinical parameters (p < 0.05–0.001) in the surgery group, whereas no such improvement was observed in the non‐surgery group. In both groups, a significant difference in total OHRQL score was noted between phases I and III (p < 0.001 for surgery and p < 0.05 for non‐surgery). The OHRQL domain scores for pain and eating/chewing function showed a significant improvement between these time points. However, no further significant improvement in OHRQL scores was achieved from phase II to III.
Conclusion
A significant improvement in oral health‐related QoL was noted between phases I and III in the surgery and non‐surgery groups. Such improvement was less pronounced in the non‐surgery vs. the surgery group. From phase II to III, neither surgery nor non‐surgical treatment yielded significant improvement in oral health‐related QoL.
German Value Set for the EQ-5D-5L Ludwig, Kristina; Graf von der Schulenburg, J.-Matthias; Greiner, Wolfgang
PharmacoEconomics,
06/2018, Letnik:
36, Številka:
6
Journal Article
Recenzirano
Odprti dostop
Objectives
The objective of this study was to develop a value set for EQ-5D-5L based on the societal preferences of the German population. As the first country to do so, the study design used the ...improved EQ-5D-5L valuation protocol 2.0 developed by the EuroQol Group, including a feedback module as internal validation and a quality control process that was missing in the first wave of EQ-5D-5L valuation studies.
Methods
A representative sample of the general German population (
n
= 1158) was interviewed using a composite time trade-off and a discrete choice experiment under close quality control. Econometric modeling was used to estimate values for all 3125 possible health states described by EQ-5D-5L. The value set was based on a hybrid model including all available information from the composite time trade-off and discrete choice experiment valuations without any exclusions due to data issues.
Results
The final German value set was constructed from a combination of a conditional logit model for the discrete choice experiment data and a censored at −1 Tobit model for the composite time trade-off data, correcting for heteroskedasticity. The value set had logically consistent parameter estimates (
p
< 0.001 for all coefficients). The predicted EQ-5D-5L index values ranged from −0.661 to 1.
Conclusions
This study provided values for the health states of the German version of EQ-5D-5L representing the preferences of the German population. The study successfully employed for the first time worldwide the improved protocol 2.0. The value set enables the use of the EQ-5D-5L instrument in economic evaluations and in clinical studies.
Purpose To examine the relationship of neighbourhood-level material and social deprivation with health-related quality of life, measured by the EQ-5D-5L, in the general adult population. Methods A ...sample of 11,835 adults living in Alberta, Canada was drawn from three combined annual Health Quality Council of Alberta Satisfaction and Experiences with Health Care Services surveys from 2012 to 2016. Neighbourhood-level material and social deprivation indices were derived using the Pampalon index and the 2006 Canadian census. The EQ-5D-5L dimensions, index and VAS scores were compared across the deprivation indices quintiles in the overall sample and by participants' sub-groups. Differences were tested using ANOVA or Chi-square test as appropriate. Multivariate linear regression models were conducted to examine the independent association of material and social deprivation with the EQ-5D-5L index and VAS scores, and multinomial logistic regression models with each of the EQ-5D-5L dimensions. Results Respondents in higher material or social deprivation categories had lower EQ-5D-5L index and VAS scores than those in the least deprived categories. Additionally, respondents with higher material deprivation were more likely to report problems on mobility, usual activities, and pain/discomfort; those with higher social deprivation were more likely to report problems on mobility, self-care, usual activities, and anxiety/depression. Conclusion Higher neighbourhood-level material and social deprivation is significantly associated with lower health-related quality of life in the general adult population. Examining the factors leading to this inequity in health between individuals living in the least and most deprived neighbourhoods is imperative to mitigating these inequities.
Background
We aimed to estimate minimally important difference (MID) for interpreting group‐level change over time for European Organisation for Research and Treatment of Cancer Quality of Life ...Questionnaire core 30 (EORTC QLQ‐C30) scores in head and neck cancer.
Methods
Data were derived retrospectively from two published EORTC trials. Clinical anchors were selected using correlation strength and clinical plausibility of the given anchor/QLQ‐C30 scale pair. MIDs for within‐group and between‐group change were estimated via the mean change method and linear regression, respectively. Distribution‐based MIDs were also examined. MIDs for two of the scales, dyspnea and nausea/vomiting, are more uncertain considering their low correlations with the anchors.
Results
Anchor‐based MIDs could be determined for deterioration in 7 of the 14 QLQ‐C30 scales assessed, and in 3 scales for improvement. MIDs varied by scale, direction of change, and anchor. Absolute MID values ranged from 5 to 15 points for within‐group change and 4 to 12 for between‐group change. Most MIDs were within 4 to 10 points.
Conclusions
Our findings, if confirmed, will aid interpreting changes in selected QLQ‐C30 scale scores over time and inform sample size calculations in future clinical trials in head and neck cancer.
Purpose The validity of the life satisfaction measures commonly used among adults has been rarely examined in adolescent samples. The present research had two main goals: (1) to evaluate the ...structural validity of the Satisfaction with Life Scale (SWLS) among adolescents and to test measurement invariance across gender; (2) to compare the criterion and convergent validity of the SWLS and single-item life satisfaction measures among adolescents. Methods Three samples of Serbian adolescents were recruited for the present research. Study 1 (N = 481, Mage = 17.01 years) examined the structure of the SWLS via confirmatory factor analysis (CFA) and evaluated measurement invariance of the SWLS across gender by a multi-group CFA. Study 2 (N = 283, Mage = 17.34 years) and Study 3 (N = 220, Mage = 16.73 years) compared the convergent validity of the SWLS and single-item life satisfaction measures. Results The results of Study 1 supported the original one-factor model of the SWLS among adolescents and provided evidence for strong measurement invariance of the SWLS across gender. The findings of Study 2 and Study 3 showed that the SWLS and single-item measures were equally valid and strongly associated (r = .734 in Study 2 and r = .668 in Study 3). No substantial differences in correlations with school success and well-being indicators were found between the SWLS and single-item measures. Conclusions Our findings support the use of the SWLS among adolescents and indicate that single-item life satisfaction measures perform as well as the SWLS in adolescent samples.
Introduction
Women with endometriosis have reduced health‐related quality of life (HRQoL). However, comparisons to the general population and other patient groups are lacking.
Material and methods
...The present cross‐sectional questionnaire study included 157 women with endometriosis, 156 women from the general population, and 837 women with rheumatoid arthritis (RA). During a period from 2012 to 2013, women aged 18‐45 years were recruited from the Norwegian Endometriosis Association and from a random sample of women residing in Oslo, Norway. HRQoL data from women with RA were included from a survey conducted in 2009 among patients of the Oslo Rheumatoid Arthritis Register. The Short Form‐36 (SF‐36) questionnaire was used to measure HRQoL.
Results
Compared with the control group, the endometriosis group had significantly reduced mean scores for all SF‐36 scales. The difference was largest for the scale bodily pain with a mean score of 47.6 in the endometriosis group vs 81.5 in the control group. Compared with the RA group, the endometriosis group had significantly reduced mean scores for the three SF‐36 scales vitality, social functioning, and mental health. The mean scores of these scales in the endometriosis group were 33.4, 62.7, and 66.3, respectively, vs 42.7, 68.8, and 72.6 in the RA group.
Conclusions
Women with moderate to severe endometriosis seem to have overall impaired HRQoL compared with women from the general population, and poorer mental HRQoL compared with women with RA.
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