Generic Quality Of Life Measures Research Articles

Quality of Life Assessments Utilized in Vitiligo Clinical Trials

Introduction. Vitiligo is an acquired autoimmune disease associated with high psychosocial burden. As novel treatments are being developed in clinical trials, assessing vitiligo disease burden extends beyond physical manifestations. Including quality of life (QoL) measures in vitiligo clinical trials can better capture disease-specific psychosocial concerns and facilitate cross comparisons amongst interventions. Objective. To determine the frequency and types of QoL measures utilized in vitiligo clinical trials and comment on how this has changed longitudinally. Methods. A search of vitiligo clinical trials using clinicaltrials.gov was conducted. Phase 2 and phase 3 trials published in English from January 2000 to July 2023 were eligible for this review. Characteristics of clinical trial parameters were compared to those of non-QoL reporting clinical trials using Pearson’s χ2 tests (or Fisher’s if low n). Results. A total of 60 clinical trials were eligible for this review, of which 40% included a QoL measure in their study design. Phase 3 clinical trials ( p = 0.002), larger (100+ participants) trials ( p = 0.063), U.S. trials ( p = 0.029), and pharmaceutical interventions ( p = 0.022) were more likely to include QoL measures in their design. The number of clinical trials has been increasing over time, with 8 trials from 2000 to 2010, 32 total trials from 2011 to 2020, and 20 trials from 2021 to 2023. The most commonly used QoL measures were the Dermatology Life Quality Index (DLQI, 55.2%), Children's Dermatology Life Quality Index (CDLQI, 13.8%), and Vitiligo-specific quality of life instrument (VitiQoL, 13.8%). Over time, the VitiQoL and CDLQI have been used more frequently. Conclusion. Although vitiligo is associated with high psychological and emotional burden, less than half of vitiligo trials utilize QoL measures. The general dermatology QoL measures, namely the DLQI and CDLQI, are the most commonly used QoL assessments. As the number of clinical trials is increasing, vitiligo-specific questionnaires may better capture unique vitiligo-specific concerns. Standardizing the types of and implementation of QoL questionnaires in clinical trials can aid in assessing outcome measures across clinical trials worldwide and allow for better data interpretation, comparability, and clinical application of results.

Relationship Between Standardized Measures of Chronic Kidney Disease-associated Pruritus Intensity and Health-related Quality of Life Measured with the EQ-5D Questionnaire: A Mapping Study.

Chronic kidney disease-associated pruritus is linked with decreased health-related quality of life assessed using disease-specific instruments. The extent to which worsening pruritus reduces generic quality of life assessed using the EQ-5D instrument is unknown. Prevalent kidney failure patients receiving in-centre haemodialysis from 5 centres completed the EQ-5D-5L quality of life measure, worst Itching Intensity Numerical Rating Scale and 5-D itch pruritus instruments. Latent class models were used to identify clusters of patients with similarly affected body parts, and mixture models were used to map the pruritus measures to the EQ-5D. Data on 487 respondents were obtained. Latent class analysis identified 3 groups of patients who had progressively worsening severity and an increasing number of body parts affected. Although the worst itching intensity numerical rating scale and 5-D itch instruments correlated with each other, only the latter had a strong relationship with EQ-5D. When controlling for age, sex, diabetes and years receiving dialysis, the meanpredicted EQ-5D utility (1: perfect health, 0: dead) decreased progressively from 0.69 to 0.41. These findings suggest that pruritus instruments that include domains capturing how the individual is physically, mentally and socially affected by their pruritus, in addition to severity, more closely approximate the EQ-5D generic quality of life measure.

A study evaluating quality of life and factors affecting it before, during and after menopause

ObjectiveTo determine if quality of life (QoL) changes before, during and after menopause and whether these changes are linked to symptoms, demographics, and/or lifestyle factors. MethodsWe undertook a cross-sectional online survey. We invited women aged between 35 and 60 years to complete the survey which included the Short-Form 36 (SF-36) generic quality of life measure, the menopause specific Utian-Quality of life (UQOL) measure, and questions about health and wellbeing, menopause symptoms and hormonal stage. The data were analysed with one-way ANOVA analysis and multivariate regression modelling. Results279 women completed the survey. Most were aged between 51 and 55 years. In the unadjusted analysis there was a tendency for QoL to deteriorate from pre to peri to menopause and then increase slightly post menopause. This was however not significant in multivariate analysis. Multivariate analysis identified that lifestyle factors significantly influenced QoL. Regular exercise resulted in better QoL scores across a number of the UQol and SF-36 sub-scales. Being very overweight and having more menopause symptoms resulted in worse QoL. ConclusionsAlthough there was a trend towards worse quality of life in the peri and menopause stages this was not significantly different in adjusted multivariate analyses. Those experiencing more symptoms had significantly worse QoL. Lifestyle factors may affect QoL, but the picture is not straightforward. It is promising that there was a trend toward improved QoL in the post-menopausal stage. These findings should inform education material and promote awareness of the menopause and its impact on QoL.(245)

Factors associated with quality of life in patients receiving lung transplantation: a cross-sectional study

BackgroundWith improved prognosis after lung transplantation (LTx), improving health-related quality of life (HRQL) in patients who have undergone LTx is a key goal. Although HRQL is improved significantly after transplantation, it is poorer than that in ordinary healthy people. However, the factors associated with poor HRQL remain unclear. This cross-sectional study aimed to identify the factors associated with poor HRQL in patients who have undergone LTx.MethodsBetween December 2018 and May 2022, 80 patients who had undergone LTx completed St. George’s Respiratory Questionnaire (SGRQ) as a disease-specific quality of life measure, the Short Form-12 (SF-12) as a generic quality of life measure, and modified Medical Research Council (mMRC) scale of dyspnea. The groups were assigned according to the median SGRQ-total score and the Japanese population standard for SF-12, and those with good HRQL were compared with those with poor HRQL. Independent factors were evaluated using multivariate analysis.ResultsWith regard to the SGRQ, there were significant differences in the forced expiratory volume in 1 s (FEV1) (P = 0.041), use of bronchodilators (P = 0.026), 6-min walk distance (6MWD) (P < 0.001), and Mmrc (P < 0.001) between better and poorer HRQL. For the SF-12 physical component summary score (PCS), age (P = 0.017), sex (P = 0.011), FEV1 (P < 0.001), forced vital capacity (FVC) (P < 0.001), diagnosis (P = 0.011), handgrip force (P = 0.003), 6MWD (P < 0.001), and Mmrc (P < 0.001) varied. Multivariate analyses revealed that Mmrc was the only independent factor in the SGRQ (P < 0.001, odds ratio [OR] = 6.65, 95% confidence interval [CI]: 2.49–17.74) and SF-12 PCS (P = 0.001, OR = 0.185, 95% CI: 0.07–0.52). There were significant correlations between the SGRQ-Total score and SF-12 PCS (correlation coefficient = -0.612, P < 0.001).ConclusionsDyspnea may be an independent factor of poor disease-specific and generic HRQL in LTx patients. The management of dyspnea may improve the HRQL in patients who have undergone LTx.

Quality of life of children and young people with anterior chest wall deformity: a systematic review of the literature

ObjectiveThe aim of this study was to evaluate the current evidence regarding the quality of life (QoL) of children and young people with anterior chest wall deformity (ACWD).MethodsUsing a defined...

Abstract 4370: How much time is needed to complete quality of life assessments in oncology trials? - Metadata analysis

Abstract Introduction: Digitalization in clinical trials introduced electronic data collection. Participants in diverse environments can use electronic devices to report their experiences with the drug by completing patient reported outcome assessments (ePROs). Quality of life (QOL) reports describe how a patient feels or functions during a treatment with a new drug. For oncology trials, QOL data is needed to prove the treatment effect and support a labeling claim. Methods: The literature search in the Web of Science for articles containing QOL keyword found ten articles with the highest number of citations. QOL instruments relevant to cancer research were identified based on the literature search. Form completion times corresponding to the cancer-specific instruments were identified and analyzed using a metadata of 948 instruments and 17,234,458 assessment submissions. Results: Three general QOL measures in oncology trials were identified: the EORTC Quality of Life Questionnaire - Core Questionnaire (EORTC QLQ-C30), Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F), and SF-36 Health Survey (SF-36). Median times of form completion in seconds (s) increased in the following order: FACIT-F &amp;lt; EORTC QLQ-C30 &amp;lt; SF-36v2 and were equal to 105 s &amp;lt; 213 s &amp;lt; 386 s. Metadata analysis showed that participants spent less than two minutes on completion of the FACIT-F assessment, which is only 18% of the estimated completion time of 10 minutes. Metadata analysis showed that it took participants three and a half minutes to complete the EORTC QLQ-C30 assessment, which is roughly one third of the estimated completion time of 11 minutes. The completion time for SF-36v2 fell within the estimated range of 5 to 10 minutes. Conclusions: Properly selected QOL instruments facilitate collection of the right data for demonstration of a treatment benefit. It is recommended to include a general oncology and a disease specific QOL instrument to show the treatment’s success of improving patient’s QOL. At the same time, the completion of the instruments should not be burdensome considering disease progression characteristic for oncology studies. Citation Format: Jowita Marszewska, Lindsay Hughes. How much time is needed to complete quality of life assessments in oncology trials? - Metadata analysis. [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 4370.

Individuals with stroke three months after hospital discharge reported worse quality of life during the COVID-19 pandemic

PurposeTo compare quality of life (QOL) of individuals with stroke three months after hospital discharge, using generic and specific QOL measures, before and during the COVID-19 pandemic. MethodsIndividuals, who were admitted to a public hospital, were recruited and evaluated before (G1) and during (G2) the COVID-19 pandemic. The groups were matched for age, sex, socio-economic status, and levels of stroke severity (National Institutes of Health Stroke Scale) and functional dependence (Modified Barthel Index). After three months of hospital discharge, they were evaluated and compared using generic (Short-form Health Survey 36: SF-36) and specific (Stroke Specific Quality of Life: SSQOL) QOL measures. ResultsSeventy individuals were included (35 in each group). Statistically significant between-group differences were found for both total SF-36 (p=0.008) and SSQOL (p=0.001) scores, indicating that individuals reported worse QOL during the COVID-19 pandemic. Furthermore, G2 also reported worse generic QOL related to the SF-36 domains of physical functioning, bodily pain, general health perception, and emotional role limitations (p < 0.01) and worse specific QOL related to following SSQOL domains: Family roles, mobility, mood, personality, and social roles (p < 0.05). Finally, G2 reported better QOL related to energy and thinking (p < 0.05) SSQOL domains. ConclusionIn general, individuals with stroke, who were evaluated during the COVID-19 pandemic three months after hospital discharge, reported worse perceptions of QOL in several domains of both generic and specific QOL measures.

Using a generic quality of life measure to determine adherence thresholds: a cross-sectional study on older adults with neurological disorders in Germany

ObjectivesMeasuring the degree of adherence to medication is essential in healthcare However, the cut-offs provided for adherence scales are often arbitrary and disease-specific, and need to be validated against a...

A systematic review of non-procedural contributors to quality of life in heart valve disease

Quality of life (QOL) is an important outcome in patients with heart valve disease, in cohorts that have received a valve replacement as well as those that have not. Existing reviews on this topic, however, focus primarily on the effect of valve intervention. This systematic review was conducted to provide an overview of non-procedural predictors of QOL in multiple forms of heart valve disease. Measures of QOL can compare outcomes between populations (‘generic’ measures) or within a specific disease state or population (‘specific’). Pubmed was searched in July 2021 for papers reporting associations of non-procedural factors with QOL. 14 papers with 8433 participants in total were included in the final selection, most of which were aortic valve intervention cohorts. Studies using both generic and specific measures of QOL were included. Sex and body mass index had minimal association with QOL in HVD, while ejection fraction displayed no association. In longitudinal studies, more severe cardiac symptoms before valve intervention were associated with worse QOL after valve intervention. There is limited information on non-procedural contributions to QOL in patients with heart valve disease. Sex, BMI, age, and ejection fraction appear to have little effect. The association of worse long term QOL post-intervention in those with worse pre-intervention symptoms raises the possibility that earlier intervention may be beneficial. Variability of results in different cohorts and between measures of quality of life indicate the need for a disease-specific measure of QOL in heart valve disease.

PD38-04 A COMMUNITY-BASED EDUCATION PROGRAM FOR OVERACTIVE BLADDER IN A PREDOMINANTLY MINORITY OLDER FEMALE POPULATION: A PILOT STUDY

You have accessJournal of UrologyCME1 May 2022PD38-04 A COMMUNITY-BASED EDUCATION PROGRAM FOR OVERACTIVE BLADDER IN A PREDOMINANTLY MINORITY OLDER FEMALE POPULATION: A PILOT STUDY Susana Martinez Diaz, Hudson Pierce, John Lee, Tirsit Asfaw, Andrew Abram, Naeem Bhojani, Dean Elterman, Kevin Zorn, and Bilal Chughtai Susana Martinez DiazSusana Martinez Diaz More articles by this author , Hudson PierceHudson Pierce More articles by this author , John LeeJohn Lee More articles by this author , Tirsit AsfawTirsit Asfaw More articles by this author , Andrew AbramAndrew Abram More articles by this author , Naeem BhojaniNaeem Bhojani More articles by this author , Dean EltermanDean Elterman More articles by this author , Kevin ZornKevin Zorn More articles by this author , and Bilal ChughtaiBilal Chughtai More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002596.04AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Knowledge gaps in available treatment and social stigmatization are barriers to care in patients with overactive bladder (OAB), especially for minority populations. We assess the feasibility of an OAB education program targeting older, minority community-dwelling females. METHODS: Women over age 55 were recruited from community centers in New York City. Individuals with a previous diagnosis of OAB were excluded to control for baseline knowledge about OAB. Eligible participants underwent an education program consisting of a slide presentation covering the following topics: bladder function, lower urinary tract anatomy, pathophysiology of OAB, effect of OAB on quality of life, pelvic floor exercise training, and bladder training. OAB symptom score and general and condition-specific quality of life scores were measured at baseline and 1 week, 3 months, and 6 months post-intervention using the Overactive Bladder Questionnaire-Short Form and Short Form-12. Change in scores over time was analyzed using a linear mixed-effects model for repeated measures. RESULTS: 37 female patients with OAB symptoms at baseline participated in the study. Most participants were from a Latino/Hispanic or Black/African American ethnic/racial background (Table 1). For our youngest subgroup (≤68 years old) significant improvements were observed at 3 and 6 months compared to 1 week post-intervention for symptom bother (3 months, -22.75, p=0.006; 6 months, -25.76; p=0.001) and condition-specific related quality of life sub-scale scores for concern (3 months, +23.76, p=0.006; 6 months, +22.15, p=0.011) and social interaction (3 months, +21.11, p=0.017; 6 months, +20.51; p=0.021). For all ages, improvements in general quality of life measures for mental health were seen at 3 and 6 months compared to baseline (3 months, +7.57, p=0.02; 6 months, +6.70; p=0.048). CONCLUSIONS: There were statistically significant improvements in symptom bother, condition-specific, and general quality of life measures following an OAB education program in a predominantly minority older female population. Further studies are needed to support efficacy and optimize design to benefit these patients in the long-term. Source of Funding: Weill Cornell Clinical and Translational Science Center grant support (CTSC GRANT UL1 TR000457) © 2022 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 207Issue Supplement 5May 2022Page: e646 Advertisement Copyright & Permissions© 2022 by American Urological Association Education and Research, Inc.MetricsAuthor Information Susana Martinez Diaz More articles by this author Hudson Pierce More articles by this author John Lee More articles by this author Tirsit Asfaw More articles by this author Andrew Abram More articles by this author Naeem Bhojani More articles by this author Dean Elterman More articles by this author Kevin Zorn More articles by this author Bilal Chughtai More articles by this author Expand All Advertisement PDF DownloadLoading ...

A Community-Based Education Program for Overactive Bladder in a Predominantly Minority Older Female Population: A Pilot Study

Introduction: Knowledge gaps regarding available treatment and social stigmatization are barriers to care in patients with overactive bladder (OAB). We assessed the feasibility of an OAB education program targeting older community-dwelling females. Methods: Community-dwelling women over 55 years old were recruited. Eligible participants underwent an education program covering continence-promotion strategies. The Overactive Bladder Questionnaire-Short Form and Short Form-12 were completed at baseline, 1 week, 3 months, and 6 months post-intervention to measure symptom bother and condition-specific and general quality of life (QoL). Data were analyzed using a linear mixed-effects model for repeated measures. Results: Thirty-seven female patients with OAB symptoms at baseline were assessed with the majority from Latino/Hispanic or Black/African American ethnic/racial backgrounds. For our youngest subgroup (≤68 years old), significant improvements were observed at 3 and 6 months compared to 1 week post-intervention for symptom bother (3 months, −22.75, p = 0.006; 6 months, −25.76; p = 0.001) and condition-specific and health-related QoL subscale scores for concern (3 months, +23.76, p = 0.006; 6 months, +22.15, p = 0.011) and social interaction (3 months, +21.11, p = 0.017; 6 months, +20.51; p = 0.021). For all age subgroups, improvements in general QoL measures for mental health were seen at 3 and 6 months compared to baseline (3 months, +7.57, p = 0.02; 6 months, +6.70; p = 0.048). Conclusions: Statistically significant improvements in symptom bother, condition-specific, and general QoL measures were observed following an OAB education program pilot study in a predominantly minority female population. Further studies are needed to support efficacy and optimize program design.

Comparing Disease-Specific and Generic Quality of Life in Korean Breast Cancer Survivors Using the FACT-B and QLI: The Importance of Instrument Selection.

Background:Quality of life (QOL) has become an important indicator for evaluating patients’ symptoms and their overall satisfaction with life. Thus, examining QOL is essential for fully understanding the life satisfaction of breast cancer survivors (BCS). However, selecting the appropriate instrument for QOL measurement is challenging, and few studies have compared disease-specific and generic QOL measures and how they reflect the impact of cancer-related symptoms on QOL in BCS. We examined QOL in BCS using both disease-specific and generic instruments and compared their representation of the QOL impacts of anxiety, depression, sleep, fatigability, and posttraumatic growth.Methods:This study involved analysis of follow-up data for an exercise intervention called the BLESS (Better Life after cancer, Energy, Strength, and Support) program, which included 40 BCS treated at 1 medical center in South Korea. Their QOL was assessed using both the Functional Assessment of Cancer Therapy-Breast (FACT-B) and Quality of Life Index (QLI).Results:Both FACT-B and QLI total scores revealed that Korean BCS had low levels of QOL. Furthermore, both FACT-B and QLI total scores were significantly related to anxiety, depression, sleep, fatigability, and posttraumatic growth in the participants. Notably, multivariate regression analysis of FACT-B and QLI total scores showed different predictors for QOL: with the FACT-B, depression was the only significant predictor, while with the QLI, posttraumatic growth was the only significant predictor.Conclusion:The selection of a given QOL instrument may affect the overall findings and interpretation of the impacts of related symptoms. The FACT-B should be considered for studies of symptoms such as depression, while the QLI is more appropriate for examining overall QOL and posttraumatic growth.

Impact of Psoriasis on Quality of Life.

Psoriasis is a multisystem disorder with a significant impact on the quality of life (QoL) of the patient. QoL in psoriasis is influenced by epidemiological factors, the type and extent of the disease, and underlying comorbidities. Various tools have been developed to assess the QoL in patients with psoriasis, namely psoriasis specific, skin specific, generic QoL, and mixed measures. In this review, we present a concise overview of the different indices and the pros and cons of various tools to assess the impact of psoriasis on patients.

The Impact of Amyloid PET Disclosure on Quality of Life in Patients With Young Onset Dementia.

The impact of amyloid positron emission tomography (PET) imaging on patient health outcomes for individuals with dementia is unknown. In the present study, we explored the association between diagnostic outcome and clinician's level of certainty with quality of life (QoL) after [18F]flutemetamol PET results were disclosed in young onset dementia patients in a memory clinic cohort. In 154 patients suspected of dementia, QoL was measured before and after [18F]flutemetamol PET results were disclosed. Multiple regression analyses were conducted with (changed) general and disease-specific QoL measures as dependent factors [QoL-Alzheimer disease (AD) and EQ-5D Dutch tariff] and etiological diagnosis and clinician's certainty as independent factors. (Change in) diagnosis of AD was associated to QOL in 2 of the 4 analyses (utility-based QoL β=0.15, P=0.010; disease-specific QoL β=2.0, P=0.037). Diagnostic certainty was associated to QOL in 1 of the 4 analyses (generic QoL β=0.002, P=0.028). The diverse results in this explorative analysis do not reflect a univocal association between diagnosis, certainty, and QoL. Nevertheless, this result could be interpreted as a possible potential for advanced diagnostic technologies for AD, which requires confirmation in future research.

Association of Bone Conduction Devices for Single-Sided Sensorineural Deafness With Quality of Life

Although bone conduction devices (BCDs) have been shown to improve audiological outcomes of patients with single-sided sensorineural deafness (SSD), their effects on the patients' quality of life (QOL) are unclear. To investigate the association of BCDs on QOL in patients with SSD. Literature search of databases (Medline, Embase, Cochrane Library, and ClinicalTrials.gov) from January 1, 1978, to June 24, 2021, was performed. Prospective interventional studies with 10 or more participants with SSD (defined as pure tone average >70 dB hearing loss in the worse hearing ear and ≤30 dB in the better hearing ear) who underwent unilateral BCD implantation and assessment of QOL before and after the intervention using a validated tool were eligible for inclusion. Studies on adults and children were eligible for inclusion. Patients with only conductive, mixed, or bilateral hearing loss were excluded. Data were extracted by 2 independent reviewers. Study clinical and demographic characteristics were obtained. Meta-analysis of mean differences in QOL scores before and after the intervention was performed. Study bias was assessed using Joanna Briggs Institute risk of bias tool. The main study outcome was mean change in QOL scores at 6 months after insertion of BCDs. The 3 QOL instruments used in the studies included the Abbreviated Profile of Hearing Aid Benefit (APHAB), the Health Utilities Index-3 (HUI-3), and the Speech, Spatial and Qualities of Hearing Scale (SSQ). The APHAB and the SSQ are the hearing-related QOL measures, whereas the HUI-3 is a generic QOL measure. A total of 486 articles were identified, and 11 studies with 203 patients met the inclusion criteria. Only adult studies met inclusion criteria. Ten of 11 studies were nonrandomized cohort studies. The BCDs assessed were heterogeneous. There was a significant statistical and clinically meaningful improvement in the global APHAB scores (mean change, 15.50; 95% CI, 12.63-18.36; I2 = 0) and the SSQ hearing qualities (mean change, 1.19; 95% CI, 0.46-1.92; I2 = 78.4%), speech (mean change, 2.03; 95% CI, 1.68-2.37; I2 = 0), and spatial hearing (mean change, 1.51; 95% CI, 0.57-2.44; I2 = 81.1%) subscales. There was no significant change detected in the mean HUI-3 scores (mean change, 0.03; 95% CI, -0.04 to 0.10; I2 = 0). The risk of bias was assessed to be low to moderate. These findings suggest that adult patients who receive BCDs may experience improvements in hearing-specific QOL measures but not in generic QOL measures. Prospective QOL studies should be considered in this cohort, particularly for children with SSD.

Cost-effectiveness of telephone cognitive behavioral therapy for osteoarthritis-related insomnia.

Osteoarthritis-related insomnia is the most common form of comorbid insomnia among older Americans. A randomized clinical trial found that six sessions of telephone-delivered cognitive behavioral therapy for insomnia (CBT-I) improved sleep outcomes in this population. Using these data, we evaluated the incremental cost-effectiveness of CBT-I from a healthcare sector perspective. The study was based on 325 community-dwelling older adults with insomnia and osteoarthritis pain enrolled with Kaiser Permanente of Washington State. We measured quality-adjusted life years (QALYs) using the EuroQol 5-dimension scale. Arthritis-specific quality of life was measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Insomnia-specific quality of life was measured using the Insomnia Severity Index (ISI) and nights without clinical insomnia (i.e., "insomnia-free nights"). Total healthcare costs included intervention and healthcare utilization costs. Over the 12 months after randomization, CBT-I improved ISI and WOMAC by -2.6 points (95% CI: -2.9 to -2.4) and -2.6 points (95% CI: -3.4 to -1.8), respectively. The ISI improvement translated into 89 additional insomnia-free nights (95% CI: 79 to 98) over the 12 months. CBT-I did not significantly reduce total healthcare costs (-$1072 [95% CI: -$1968 to $92]). Improvements in condition-specific measures were not reflected in QALYs gained (-0.01 [95% CI: -0.01 to 0.01]); at a willingness-to-pay of $150,000 per QALY, CBT-I resulted in a positive net monetary benefit of $369 with substantial uncertainty (95% CI: -$1737 to $2270). CBT-I improved sleep and arthritis function without increasing costs. These findings support the consideration of telephone CBT-I for treating insomnia among older adults with comorbid OA. Our findings also suggest potential limitations of the general quality of life measures in assessing interventions designed to improve sleep and arthritis outcomes.

Interrelations between mental health, generic and thyroid-related quality of life in patients with Hashimoto’s thyroiditis receiving levothyroxine replacement

The assessment of health-related quality of life (QoL) in chronic conditions is considered as relevant, especially in patients with hypothyroidism where a high comorbidity with depressive and anxiety issues is reported. The present cross-sectional pilot study aims at: i) examining the correlation of thyroid-specific and generic measures of QoL in patients with Hashimoto’s Thyroiditis (HT); ii) investigating the associations of generic and thyroid-specific measures of QoL with depression and anxiety in patients with HT; iii) comparing generic and thyroid-specific measures of QoL in patients with HT versus controls. Twenty-one patients with serologically and/or ultrasonographically verified HT and sixteen controls with non-toxic goiter or post-surgical hypothyroidism were recruited for this study. Generic and disease-specific QoL were assessed by Health Survey Short Form-36 (SF-36) and Thyroid Patient Reported Outcome (ThyPRO) questionnaires, respectively, whereas depression and anxiety were measured through Beck Depression Inventory-second edition (BDI-II) and Hamilton Anxiety Rating Scale (HAM-A) questionnaires, respectively. Findings showed that ThyPRO and SF-36 scores were associated with each other only regarding the mental health domain, and that such QoL measures were consistently associated with depression levels but not with anxiety. Besides, no statistically significant difference was found between patients with HT and controls with regard to generic and thyroid-specific QoL. The present study suggests that generic and disease-specific measures of QoL can sufficiently assess the mental functioning domain and capture depressive symptoms, but only thyroid-specific measures (such as ThyPRO) can provide an accurate examination of physical aspects of QoL and the overall disease impact in patients’ lives. Besides, some methodological limitations should be taken into account in both using generic and disease-specific instruments with regard to their tendency to underestimate possible anxiety problems.

A Summary of the Meetings of the Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) International Multidisciplinary Consensus

A Summary of the Meetings of the Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS) International Multidisciplinary Consensus

Psychometric properties of the Inventory of Life Quality in children and adolescents in Norwegian Sign Language

BackgroundSeveral studies have assessed the Quality of Life (QoL) in Deaf and hard-of-hearing (DHH) children and adolescents. The findings from these studies, however, vary from DHH children reporting lower QoL than their typically hearing (TH) peers to similar QoL and even higher QoL. These differences have been attributed to contextual and individual factors such as degree of access to communication, the participants’ age as well as measurement error. Using written instead of sign language measures has been shown to underestimate mental health symptoms in DHH children and adolescents. It is expected that translating generic QoL measures into sign language will help gain more accurate reports from DHH children and adolescents, thus eliminating one of the sources for the observed differences in research conclusions. Hence, the aim of the current study is to translate the Inventory of Life Quality in Children and Adolescents into Norwegian Sign Language (ILC-NSL) and to evaluate the psychometric properties of the self-report of the ILC-NSL and the written Norwegian version (ILC-NOR) for DHH children and adolescents. The parent report was included for comparison. Associations between child self-report and parent-report are also provided.MethodsFifty-six DHH children completed the ILC-NSL and ILC-NOR in randomized order while their parents completed the parent-report of the ILC-NOR and a questionnaire on hearing- and language-related information. Internal consistency was examined using Dillon-Goldstein’s rho and Cronbach’s alpha, ILC-NSL and ILC-NOR were compared using intraclass correlation coefficients. Construct validity was examined by partial least squares structural equation modeling (PLS-SEM).ResultsRegarding reliability, the internal consistency was established as acceptable to good, whereas the comparison of the ILC-NSL with the ILC-NOR demonstrated closer correspondence for the adolescent version of the ILC than for the child version. The construct validity, as evaluated by PLS-SEM, resulted in an acceptable fit for the proposed one-factor model for both language versions for adolescents as well as the complete sample.ConclusionThe reliability and validity of the ILC-NSL seem promising, especially for the adolescent version, even though the validation was based on a small sample of DHH children and adolescents.

Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS): An International Multidisciplinary Consensus

Development of a Core Outcome Set for Therapeutic Studies in Eosinophilic Esophagitis (COREOS): An International Multidisciplinary Consensus