Specific Quality Of Life Instrument Research Articles

Enhancing life with celiac disease: unveiling effective tools for assessing health-related quality of life.

Celiac disease (CD) is an autoimmune chronic enteropathy provoked by gluten ingestion in genetically predisposed individuals. Considering it´s only safe treatment is a lifelong gluten-free diet, the burden of living with the disease becomes evident, as well as the need to assess CD health-related quality of life (HRQOL). This review aims to identify and analyze the instruments used to evaluate the HRQOL of adults with CD. This integrative review using a systematic approach was designed to achieve high scientific standards. Accordingly, the search strategy was developed and executed as recommended by the guideline of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Detailed individual searches were developed to Pubmed, Science Direct, Scopus, Web of Science, and Google Scholar. After careful analysis of the papers, 43 studies were included, in which seven instruments were identified: Celiac Disease Questionnaire (CDQ) (n=21), Celiac Disease Specific Quality of Life Instrument (CD-QOL) (n=17), Celiac Disease Assessment Questionnaire (CDAQ) (n=4), CeliacQ-7 (n=1), CeliacQ-27 (n=1), Black and Orfila´s self-developed instrument (n=1) and the Coeliac Disease Quality of Life Questionnaire (CDQL) (n=1). The CDQ and CD-QOL were the two most applied instruments. Since the first focuses on the physical and mental symptoms related to the disease and the second focuses on the emotional repercussions of adhering to the GFD treatment for life (dysphoria), the CDQ application is an interesting option for countries that struggle with public policies for CD patients and patients with active CD. The CD-QOL could be used for countries with strict regulations for CD and gluten-free products and populations in remission. When comparing results among different populations, it is preferable to utilize culturally validated instruments, which have been applied across multiple countries, providing greater comparability between study findings.

Estimating health related quality of life effects in vitiligo. Mapping EQ-5D-5 L utilities from vitiligo specific scales: VNS, VitiQoL and re-pigmentation measures using data from the HI-Light trial

BackgroundVitiligo is reported to affect 2% of the world’s population and has a significant impact on health related quality of life (HRQoL). The relationship between HRQoL and clinical outcomes used in vitiligo require further examination. Mapping condition specific measures of HRQoL: vitiligo specific quality of life instrument (VitiQoL), vitiligo noticeability scale (VNS) and vitiligo re-pigmentation scores (RPS) to the EQ-5D have not yet been reported.MethodsData collected from a randomised clinical trial (HI-Light) in vitiligo was used to develop mapping algorithms for the EQ-5D-5 L and the relationship between HRQoL, clinical outcomes and EQ-5D were investigated. Two EQ-5D-5 L value sets (Van Hout and Alava) using linear and non-linear models were considered. Logistic regression models were used to model the probability of vitiligo noticeability (VNS) in terms of RPS, EQ-5D and VitiQoL scores.ResultsMapping from RPS appeared to perform better followed by VNS for the Alava crosswalks using polynomial models: Mean observed vs. predicted utilities of 0.9008 (0.005) vs. 0.8984 (0.0004) were observed for RPS. For VNS, mean observed vs. predicted utilities of 0.9008 (0.005) vs. 0.8939 (0.0003) were observed. For VitiQoL, mean observed vs. predicted utilities of 0.9008 (0.005) vs. 0.8912 (0.0002) were observed. For patients with the least re-pigmentation (RPS < 25%), a Total VitiQoL score of about 20 points gives around an 18% chance of vitiligo being no longer or a lot less noticeable.ConclusionThe algorithm based on RPS followed by VNS performed best. The relationship between effects from vitiligo specific HRQoL instruments and clinical RPS was established allowing for plausible clinically relevant differences to be identified, although further work is required in this area.

#5510 CKD-ASSOCIATED PRURITUS SEVERITY AND ITS ASSOCIATION WITH BODY DISTRIBUTION AND EQ-5D HEALTH-RELATED QUALITY OF LIFE IN HAEMODIALYSIS PATIENTS

Abstract Background and Aims Chronic Kidney Disease associated pruritus (CKD-aP) is common affecting 40% of people with kidney disease receiving dialysis. It is associated with decreased health-related quality of life (HRQoL) as assessed using disease-specific instruments. A better understanding of how the severity of CKD-aP is related to the distribution of affected body parts and generic of HRQoL assessed using the EQ-5D instrument could improve the identification, assessment, and treatment of CKD-aP including advocating for access to new therapies. Method Prevalent in-centre haemodialysis patients from five centres prospectively completed the EQ-5D-5L HRQoL questionnaires, the severity-based worst itch numeric rating scale (WI-NRS) and multi-dimensional 5-D itch pruritus disease specific quality of life instruments. Latent class mixture models were used to identify clusters of patients with similarly affected body parts as assessed through the 5-D itch and map the pruritus measures to the EQ-5D utility value (1 being perfect health and 0 being dead, heavily skewed). Patient demographics, comorbidities, dialysis prescription and anti-pruritus medications were collected. Results Pruritus data on 485 respondents were obtained. No pruritus was reported in 164 (33.8%), with 117 (24.1%) reporting mild, 123 (25.4%) reporting moderate and 81 (16.7%) reporting severe pruritus. Commonly affected body parts included groin (22%), upper arms (21%), forearms (11%), and back (10%). Anti-pruritus medication use across CKD-aP severity (none to severe) was 40.6%, 38.5%, 36.6% and 55.6%, and varied by body part with 38.8%, 21.0% and 14.5% use in those affected in the upper limbs, groin and lower legs respectively. Latent class analysis identified three groups of patients who had progressively worsening severity and number of body parts affected, but the distribution of affected body parts was relatively constant (left-hand figure) and reduction in EQ-5D by affected body part was similar. Although the WI-NRS and 5-D itch instruments correlated with each other, only the 5-D itch had a strong relationship with EQ-5D-3L: Controlling for age, sex, diabetes, and years receiving dialysis, predicted EQ-5D utility dropped linearly from 0.69 to 0.41 (right-hand figure). Conclusion Contemporary UK data shows CKD-aP remains highly prevalent amongst people with kidney failure on dialysis. Severe CKD-aP was commonly reported despite half of the patients with severe CKD-aP receiving antipruritic medication, illustrating a high unmet need and likely undertreated. Although there were similar reductions in HRQoL, medication use varied by body part and those whose groin is affected may be reporting other body parts to access therapies. High use of CKD-aP medications in none or mild severity may represent more severely affected individuals benefiting from these drugs as the cross-sectional nature of the study means those who reported no pruritus may have had pruritus in the past which resolved in response to the medications prescribed and reported in these analyses. Overall, as it worsens CKD-aP appears to affect a similar distribution of body parts. Pruritus instruments that include domains that are broader than just pruritus severity more closely approximate the EQ-5D generic HRQoL measure and therefore more strongly advocate for the value of treating this unpleasant condition. Funded by CSL Vifor.

Validation and the associated factors of the Malay version of systemic lupus erythematosus-specific health-related quality of life questionnaires (SLEQoL and LupusQoL).

To assess the reliability and validity of two disease-specific questionnaires that assess the quality of life (QoL) among patients with Systemic Lupus Erythematosus (SLE); SLEQoL and LupusQoL in Malay language. This study also identified the factors affecting each domain of the questionnaires. This cross-sectional study was conducted from June 2021 until April 2022, and SLE patients were recruited to complete the SLEQoL, LupusQoL and Short Form Health Survey (SF-36) in Malay language. Disease activity were recorded using the modified SLE Disease Activity Index (M- SLEDAI) and British Isles Lupus Assessment Group 2004 (BILAG-2004) index. Presence of organ damage was determined using the SLICC Damage index. Cronbach's alpha was calculated to determine internal consistency while exploratory factor analysis was done to determine the construct validity. Concurrent validity was evaluated using correlation with SF-36. Multiple linear regression analysis was deployed to determine the factors affecting each domain of SLEQoL and LupusQoL. A total of 125 subjects were recruited. The Cronbach's α value for the Malay-SLEQoL (M-SLEQoL) and Malay-LupusQOL (M-LupusQoL) was 0.890 and 0.944 respectively. Exploratory factor analysis found formation of similar number of components with the original version of questionnaires and all items have good factor loading of >0.4. Both instruments also had good concurrent validity with SF-36. M-SLEQoL had good correlations with BILAG-2004 and M-SLEDAI scores. Musculoskeletal (MSK) involvement was independently associated with lower M-SLEQoL in physical function, activity and symptom domains. Meanwhile, MSK and NPSLE were associated with fatigue in M-LupusQoL. Both M-SLEQoL and M-LupusQoL are reliable and valid as disease -specific QoL instruments for Malaysian patients. The M-Lupus QoL has better discriminative validity compared to the M-SLEQoL. SLE patients with MSK involvement are at risk of poor QoL in multiple domains including physical function, activity, symptoms and fatigue.

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.

The Hairdex quality of life instrument-A translation and psychometric validation in patients with alopecia areata.

The German Hairdex quality of life (QoL) instrument is specific to hair and scalp diseases, developed for self-rating and consists of 48 statements divided into five domains: Symptoms, Functioning, Emotions, Self-confidence and Stigmatisation. There was a need of a Swedish reliability tested, validated hair and scalp specific QoL instrument why the German Hairdex was chosen to be translated and reliability tested in a systematic way. To make a translation, a reliability test of stability, and validation of the German Hairdex QoL instrument among 100 Swedish patients with a dermatological ICD-10 diagnosis of alopecia areata (AA). An eight-step method by Gudmundsson was used as a model with a forward and backward translation and with comments from an expert panel. A statistical test-retest (ICC (2,1)) analysis was made, followed by an internal consistency analysis. A comparison between the German and Swedish Hairdex-S constructs by a principal component analysis was performed. The Hairdex-S was very well accepted by patients. The ICC(2,1) test-retest showed a good to excellent correlation of 0.91(CI [0.85-0.95]). Internal consistency was α=0.92. Like the original Hairdex, Hairdex-S showed good factorability with a Kaiser-Meyer-Olkin measure of 0.82 and with one component explaining 70% of the variance: original Hairdex instrument (69%). When tested on patients with AA, the domains Functioning and Emotions had the strongest loadings, followed by Stigmatisation and Self-confidence. Younger AA patients at self-assessment and patients who reported to be younger at the onset of AA, scored statistically significantly higher on the Hairdex-S, indicating an overall lower QoL on domains Emotions and Functioning, respectively. The Hairdex-S is very well accepted by AA patients, shows very good psychometric properties, and a very good agreement with the original Hairdex. The Swedish Hairdex instrument can be recommended for evaluation of patients QoL as well as for research purposes.

Neuropathy-and foot-ulcer specific quality of life instrument (NeuroQoL): Translation, cross-cultural adaptation and content validation in Hindi

BackgroundNeuropathy-and foot ulcer-specific quality of life instrument (NeuroQoL) is not available in Hindi language which is one of the most spoken languages in the world. Hence, we aimed to translate, cross-culturally adapt and content validate NeuroQoL into Hindi language (NeuroQoL-H). MethodsNeuroQoL is translated and cross-culturally adapted into Hindi language (NeuroQoL-H) using the guidelines proposed by Beaton and colleagues. Both item and scale levels content validity index (I-CVI & S-CVI) were reported for the validation and pretesting was performed with, n = 51 patients with diabetes. Floor and ceiling effects were reported. ResultTotal score of content validated and pretested, NeuroQoL-H with, n = 51 patients with diabetes is, 60 (36,109). For all the items in NeuroQoL-H, I-CVI ≥ 0.8 and S-CVI = 0.95. The floor effect is (24 %) while the ceiling effect is (1 %). ConclusionNeuroQoL-H scale is a valid outcome measure among Hindi speaking patients with diabetes.

Intravesical injection of botulinum toxin type a may be an effective treatment option for autonomic dysreflexia in patients with high-level spinal cord injury

Objective To evaluate the efficacy of intravesical injection of botulinum toxin type A (BTX-A) for neurogenic detrusor overactivity (DO) in reducing the frequency and severity of autonomic dysreflexia (AD). Design A cross-sectional nonrandomized trial with before (baseline) and after (follow-up) assessments. Setting A single spinal cord injury (SCI) rehabilitation center in China. Participants Twenty-five patients with SCI at or above T6 and a history of AD who underwent urodynamic studies (UDS) before and 3 months after BTX-A injection. Interventions Received bladder injection treatment wtih 200 U BTX-A. Outcome Measures The maximum detrusor pressure(Pdetmax) and voume at first DO(VFIDC), baseline and overall maximum systolic blood pressure (SBP) during UDS, and scores of Incontinence Specific Quality of Life Instrument (IQoL) were recorded before and 3 months after the injection. The change in SBP (ΔSBP) from baseline to maximum SBP during UDS was calculated to assess the severity. The frequency of AD was recorded using ambulatory blood pressure monitoring during a 24 h period before and 3 months after the injection. Results BTX-A injection decreased the Pdetmax and increased the VFIDC and mean urine volume per catheterization increased. The maximum SBP and the ΔSBP during UDS decreased significantly decreased after the injection (151.44 ± 13.92 vs 133.32 ± 9.20 mmHg and 49.44 ± 12.81 vs 33.08 ± 9.11 mmHg respectively, P < 0.05). The frequency of bladder-related ADs (i.e. performed a clean intermittent catheterization or leakage) during a 24-h period significantly decreased from 11.04 ± 1.81–7.88 ± 2.15 (P < 0.001). Conclusions BTX-A decreases the severity of SBP increase and the number of AD episodes 3 months after intravesical injection.

Health-related quality of life in women with endometriosis: psychometric validation of the Endometriosis Health Profile 30 questionnaire using confirmatory factor analysis.

STUDY QUESTIONWhich of the competing models of the Endometriosis Health Profile 30 Questionnaire (EHP-30) factor structure is best supported by confirmatory factor analysis (CFA)?SUMMARY ANSWERFindings support a five-factor first-order model of the EHP-30, thereby lending support to the model originally suggested by the questionnaire developers.WHAT IS KNOWN ALREADYEndometriosis has a negative impact on quality of life, and measures specifically developed to address this impact, such as the EHP-30, are vital in research and disease management. Previous studies have found different models of the EHP-30 factor structure, and generated uncertainty regarding how to use the questionnaire. CFA can be applied to compare competing factor models and determine the underlying structure of a questionnaire.STUDY DESIGN, SIZE, DURATIONThis cross-sectional multicenter study included 304 women with endometriosis recruited from three different public health service endometriosis clinics (referral centers for treatment of severe endometriosis) and the Danish Endometriosis Patients Association from 2014 to 2015.PARTICIPANTS/MATERIALS, SETTING, METHODSDiagnosis of endometriosis was confirmed in medical records for 84.2% and by histology for 66.8% of participants. Questionnaires (the licensed Danish version of the EHP-30) were sent by post two times with a 6- to 12-week interval. CFA was used to examine construct validity and Bland–Altman plots to examine test–retest reliability and the convergent validity with the Short Form 36 version 2.MAIN RESULTS AND THE ROLE OF CHANCEResponse rate was high (87.6%). CFA supported the original first-order five-factor structure of the EHP-30, and thereby, the use of five separate scale-scores in clinical and research practice. Visual inspection of Bland–Altman plots suggested excellent test–retest reliability of the EHP-30 and supported the use of a disease specific quality of life instrument for women with endometriosis.LIMITATIONS, REASONS FOR CAUTIONDiagnosis could not be confirmed through histology data in 33.2% of participants. However, subgroup analyses based on women with confirmed histology only, yielded similar results. Data related to menstrual cycle stage and the use of hormonal and pain medication during questionnaire completion were not collected. A larger study, including data from different countries on different continents, would be better designed to exclude potential population bias.WIDER IMPLICATIONS OF THE FINDINGSEHP-30, with its original five-factor structure, appears to be a valid, stable, and specific quality of life measure for women with endometriosis. It seems easy to understand, quick to administer, and importantly, scoring might be unaffected by cyclical/menstrual pain symptoms related to endometriosis. The finding of a five-factor model from different studies across several countries supports the crosscultural validity of the EHP-30.STUDY FUNDING/COMPETING INTEREST(S)This work was supported by the Danish Endometriosis Association, which is a nongovernmental organization run by women with endometriosis and by a scholarship from the Health Research Fund of Central Denmark Region. The authors have no conflicts of interest.TRIAL REGISTRATION NUMBERThe Danish Data Protection Agency (J.nr: 2013-41-2264).

Responsiveness of Health-Related Quality of Life Patient-Reported Outcome Measures in Women Receiving Conservative Treatment for Urinary Incontinence: A Systematic Review

Background: Responsive patient-reported outcome measures (PROMs) are able to detect change induced by a treatment. It is unknown whether PROMs on urinary incontinence (UI) are responsive in a conservative management setting. Objective: To systematically review the responsiveness of recommended PROMs (grade A) for the assessment of health-related quality of life in women receiving conservative treatment for UI. Study Design: Systematic review. Methods: A literature search was conducted on MEDLINE, EMBASE, and CINAHL. Selection criteria included women with UI undergoing conservative treatment, grade A-recommended PROM measuring the impact of UI on health-related quality of life, at least 1 responsiveness index, and original results. Two reviewers independently performed screening, data extraction, and methodological quality assessment using COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN). A descriptive analysis was conducted. Results: Five studies, including 5 PROMs, were retained (n = 672 participants). Participants had mixed UI (n = 3 studies) or stress UI (n = 2 studies). Flaws in methodological quality were identified (n = 1 study) for the assessment of responsiveness (COSMIN Box I) and (n = 3 studies) for interpretability (Box J). Highest internal responsiveness was found for the International Consultation on Incontinence Questionnaire—Urinary Incontinence Short Form (ICIQ-UI SF) (standardized response mean: 2.07, effect size = 2.12) and highest external responsiveness was found for the Protection Amount Frequency Adjustment Body Image Questionnaire (PRAFAB-Q) (area under the curve: 0.96). Conclusion: Four questionnaires presented at least 1 high responsiveness index (Urinary Incontinence Specific Quality of Life Instrument [I-QOL], PRAFAB-Q, ICIQ-UI SF, and International Consultation on Incontinence Questionnaire—Lower Urinary Tract Symptoms Quality of Life Modules [ICIQ-LUTSqol]). While the ICIQ-UI presented the highest overall responsiveness index, the PRAFAB-Q, an informative and brief questionnaire for clinical use, had the highest index with the highest methodological quality. There is a need to further confirm responsiveness of PROMs in this population and context.

Validation of the Nasal Obstruction Symptom Evaluation Scale in Pediatric Patients.

The Nasal Obstruction Symptom Evaluation (NOSE) is a disease specific quality of life instrument developed and validated in adults. The objective of this study is to evaluate the validity of the NOSE scale for pediatric nasal obstruction. We also examined the effect of septoplasty with bilateral inferior turbinate reduction in this population. A validation study at a tertiary care children's hospital. Thirty-eight pediatric patients who underwent septoplasty and bilateral inferior turbinate reduction between 2014 and 2018 were included. Patients were administered the NOSE instrument on the day of their clinic evaluation, the day of surgery, and at their 6 to 8-week post-operative appointment. A sample of 40 pediatric patients with non-rhinologic complaints was also included. Confirmatory factor analysis was performed to evaluate the factorial validity of the NOSE instrument. Of the 78 patients included, the mean age was 15.4 years (SD 3.4). In the confirmatory factor analysis, factor loadings were all significant and ranged from 0.95 to 0.99. Internal consistency reliability using Omega and maximal reliability H indices were well above recommended standards (Omega=0.983 and maximal H=0.988). Test-retest reliability was also adequate. Mean NOSE scores significantly improved following surgery (from 96.7 [SD 6.2] to 8.8 [SD 7.8]; mean difference=-87.9; 95% CI: -84.5, -91.3; P < .001). Similar improvements were observed across age groups. The NOSE scale is a valid and reliable quality of life instrument for pediatric patients with nasal obstruction. Nasal septoplasty with bilateral turbinate reduction substantially improved symptoms of nasal obstruction. 4 Laryngoscope, 131:E2594-E2598, 2021.

Initial Experience with Mirabegron for the Treatment of Neurogenic Lower Urinary Tract Dysfunction

Background: Though anticholinergic drugs are considered the standard treatment for neurogenic detrusor overactivity, it is far from an ideal tool, because of their adverse effects such as Constipation or not respond sufficiently for a substantial proportion of patients. Recently mirabegron has become a commonly used overactive bladder medication in the general population, but few studies about mirabegron for the treatment of neurogenic detrusor overactivity. Objective: To evaluate the efficacy and safety of mirabegron for the treatment of neurogenic lower urinary tract dysfunction. Study Design: Prospective study. Methods: This prospective study included 13 adult patients with neurogenic lower urinary tract dysfunction as a result of spinal cord injury. All patients receiving mirabegron treatment (50 mg once daily) at least 6 weeks. The effective outcomes included the mean urine volume per catheterization, urinary incontinence episodes and Incontinence Specific Quality of Life Instrument. We monitored the blood pressure and heart rate to assess the cardiovascular safety, other adverse events were also recorded. Results: A total of 13 patients were included. After 6 weeks of treatment, all patients experienced a significant increase in the mean volume of per catheterization from 238.46 ± 65.43 ml to 327.69 ± 59.04 ml (p = 0.001). There is a significant reduction in the volume of urine leakage (463.85 ± 247.98 ml VS 180.00 ± 190.96 ml, p = 0.003) and incontinence episodes per 24 h (4.46 ± 2.03 VS 1.92 ± 1.50, p = 0.001). Significant improvement in mean Incontinence Specific Quality of Life Instrument was also found (p = 0.001). No patients reported dry mouth during the study, and the cardiovascular safety were acceptable. Conclusion: Mirabegron is safe and effective in the treatment of neurogenic lower urinary tract dysfunction. It might be a good choice for reducing the cessation of clean intermittent catheterization.

Reliability and validity of the Chinese version of the vitiligo specific quality of life instrument (VitiQoL)

Background: Vitiligo is an acquired, idiopathic skin disorder that can significantly affect the health-related quality of life (QoL). The vitiligo-specific QoL instrument (VitiQoL), recently developed by an American group, was found to be a reliable patient-reported outcome measure in both Brazilian and Iranian patients. Methods: The VitiQoL was initially cross-culturally adapted to Chinese through forward-backward translation. The Chinese version of the VitiQoL was then distributed to 182 vitiligo patients together with the dermatology life quality index (DLQI) and Skindex-16 questionnaire. Then, the reliability and validity of the Chinese version of the VitiQoL was assessed by statistical analysis. Results: The Chinese version of the VitiQoL showed high internal consistency (Cronbach alpha = 0.958) and test–retest reliability (intraclass correlation coefficient = 0.887). Convergent validity testing showed that the correlation coefficient for the Chinese VitiQoL and DLQI was 0.70 (P &lt; 0.01), the Chinese VitiQoL and Skindex-16 each was 0.84 (P &lt; 0.01), and for the Chinese VitiQoL (questions 1–15 and 16) was 0.62 (P &lt; 0.01). Confirmatory factor analysis revealed two important factors within the VitiQoL: Participation limitation and stigma. Conclusion: The Chinese version of the VitiQoL questionnaire has sufficient reliability and validity to be used to evaluate Chinese vitiligo patients' QoL.

Measuring quality of life for people with common mental health problems

Background It is important to identify valid and acceptable outcome measures so that interventions evaluating common mental health problems can be assessed appropriately. Some advocate the use of generic preference-based measures claimed to be applicable for all health interventions, but others argue that they are insensitive for common mental health problems. The aim of this paper is to evaluate the Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), to be used in cost-effectiveness studies in people with common mental health problems. Method The CORE-OM measure was tested for completeness, acceptability and responsiveness in a pilot study. Analyses for missing data, distribution of scores, and standardised response means (SRMs) were calculated. Results Missing data did not exceed 5% for any of the CORE-6D items both at baseline and follow-up. The overall comprehension rate was high, and only 19 participants (14%) requested clarifications to complete the questionnaire. As expected in a feasibility study, there was a small and non-significant SRM. Conclusion CORE-OM is a valid and acceptable instrument to evaluate quality of life for people with common mental health problems. More research is needed with larger sample sizes to compare CORE-6D with other condition specific quality of life instruments.

PCN231 PHYSICIAN-REPORTED COMORBIDITIES AND TREATMENT MANAGEMENT IN PATIENTS WITH NON-METASTATIC CASTRATION-RESISTANT PROSTATE CANCER

To understand treatment management of non-metastatic castration-resistant prostate cancer (nmCRPC) in patients with pre-existing comorbidities. Physicians who treated nmCRPC patients with systemic therapy were recruited from a US physician panel for an online survey (Sept-Oct 2019). All data were physician-reported and comprised measures describing physician treatment practice and demographic characteristics, as well a 'typical' nmCRPC patient from past 6 months (e.g., health profile, disease management, and quality of life [based on the Prostate Cancer Specific Quality of Life Instrument, PROSQOLI). Chi-square, Fisher's exact, or median tests examined differences between physician specialty Fifty physicians (56% urologists, 44% oncologists) participated in the survey. Urologists reported treating more nmCRPC patients in the past 6-months than did oncologists (median=18 vs 9 patients, respectively; p<0.001). The most common treatments reported were leuprolide acetate (82%), enzalutamide (80%), and apalutamide (70%) with no difference by physician specialty (p>0.05). Most physicians (∼90%) reported at least one patient with hypertension, diabetes, myocardial infarction, sexual dysfunction or urinary issues, and up to 28% of physicians reported at least two-thirds of their patients having any one of these conditions. Between 23-46% of physicians reported that up to one-third of these patients' comorbidities were not well-controlled prior to nmCRPC treatment. About one-third of physicians reported ever adjusting the dose or switching nmCRPC treatment due to one of these comorbidities. For example, 31% of physicians reported adjusting cancer treatment dosing and 34% reported switching cancer treatment for patients with hypertension. Physician-reported PROSQOLI for a 'typical' nmCRPC patient prior to and following treatment noted increased fatigue (median difference=5.5, p=0.019) and limited enjoyment time (median difference=4.0, p=0.056) following treatment. The prevalent comorbidity burden in nmCRPC patients can impact treatment decisions. Understanding patient health and quality of life burden are relevant for identifying critical target areas in the evolving landscape of nmCPRC treatment.

Prospective memory and brain metastases: a relevant target for rehabilitation in post-operative patients?

The study investigated the prospective memory (PM) functioning among patients with brain metastases (BM), eligible for neurosurgy/radiosurgery, and its relationships with depression and quality of life (QoL). This case-healthy-control, cross-sectional study, comprised 160 participants, including 49 patients with BM from various cancers treated with neurosurgery or radiosurgery. They were compared with 111 matched controls on a set of neuropsychological tests, including the MoCA global cognitive test and an experimental PM task 'PROMESSE'. Participants also completed a depression scale (BDI-II), a generic (SF-12) and a specific (QLQ-C30) QoL instrument for cancer patients. Multivariate analyses were conducted on various PM outcomes, in particular on event-based (EBPM) and time-based (TBPM) PM performances. After adjusting for age and socio-cultural level, patients with BM performed worse than the control on the PM task (p < .0001) [OR 1.05; 95%CI (1.01-1.08)], whatever the location of BM (frontal versus temporal lobe). Patients with infratentorial BM exhibited better TBPM performances than patients with supratentorial BM (p = .02). The global PM performance was positively correlated with the MoCA (r = .45) and the SF-12 global score (r = .34), and negatively with the BDI-II score (r = - .20), the number of BM (r = - .34) and the volumetric of the BM (r = - 29). The TBPM performance was linked to the global QoL (r = .40) in patients. The study showed a significant PM deficit in patients with BM eligible for a neurosurgy/radiosurgery, which is linked to damaged QoL and which likely maintains some depressive affects. Prospective memory rehabilitation program should especially focus on TBPM for post-operative patients with BM.

A Novel Quality of Life Instrument for Patients with an Abdominal Aortic Aneurysm

The surveillance and treatment of abdominal aortic aneurysms (AAAs) may impact patient quality of life (QOL). A novel AAA specific QOL instrument was developed and validated to quantify the impact of AAA surveillance on QOL. The study was performed in two phases: development (2011-2013) and validation (2013-2014) of a survey instrument. Content was informed by focus groups at three centres (22 patients) and two multidisciplinary physician focus groups (6 vascular surgeons, 7 primary care providers). Cognitive interviews (17 patients) ensured questions were understood as intended. The final survey was mailed to AAA patients at six US institutions. Patients were scored on two AAA specific domains of QOL: emotional impact (EIS) and behavioural change (BCS), range 0-100 with higher scores indicating worse quality of life. Test retest reliability and internal consistency were assessed. Discriminant validity was determined by comparing scores between patients under surveillance vs. those who had undergone AAA repair. Scores were externally validated by correlation with the Short Form (SF)-12. A total of 1,008 (73%) of 1,373 patients returned surveys: 351 (35%) were under surveillance, 657 (65%) had undergone repair (endovascular, 414; open, 179; unsure, 64). Median EIS was 11 (range 0-95; IQR 7-26). Median BCS was 13 (range 0-100; IQR 9-47). To test reliability, 337 patients repeated the survey after four weeks with no significant differences between scores over time. EIS and BCS demonstrated good internal consistency (Cronbach's Alpha 0.85 and 0.75 respectively). There was strong correlation between scores (r=0.53) and both related moderately to SF-12 scores (r=0.45 and r=0.39, respectively). Patients under AAA surveillance had worse EIS than repair patients (22 vs. 13; p<.001). Patients with a higher perceived rupture risk had a worse EIS (45 vs. 12; p<.001) and BCS (30 vs. 13; p<.001). An AAA specific QOL instrument was successfully created and validated. The range of impact on QOL by AAA surveillance is broad. For most patients the impact is minimal, but for some, especially those with a greater perceived rupture risk, it is severe.

Psychometric properties and feasibility of use of dementia specific quality of life instruments for use in care settings: a systematic review.

Over 400,000 people live in care home settings in the UK. One way of understanding and improving the quality of care provided is by measuring and understanding the quality of life (QoL) of those living in care homes. This review aimed to identify and examine the psychometric properties including feasibility of use of dementia-specific QoL measures developed or validated for use in care settings. Systematic review. Instruments were identified using four electronic databases (PubMed, PsycINFO, Web of Science, and CINAHL) and lateral search techniques. Searches were conducted in January 2017. Studies which reported on the development and/or validation of dementia specific QoL instruments for use in care settings written in English were eligible for inclusion. The methodological quality of the studies was assessed using the COSMIN checklist. Feasibility was assessed using a checklist developed specifically for the review. Six hundred and sixteen articles were identified in the initial search. After de-duplication, screening and further lateral searches were performed, 25 studies reporting on 9 dementia-specific QoL instruments for use in care home settings were included in the review. Limited evidence was available on the psychometric properties of many instruments identified. Higher-quality instruments were not easily accessible or had low feasibility of use. Few high-quality instruments of QoL validated for use in care home settings are readily or freely available. This review highlights the need to develop a well-validated measure of QoL for use within care homes that is also feasible and accessible.

Качество жизни урологических больных

Achieving a high quality of life for patients is a paradigm of modern medicine. The doctrine of the quality of life, originated in the 60s of the twentieth century, is currently actively developing in all fields of medicine, including urology. This article reviews the history, terminology, and methods of studying the quality of life. Along with the general questionnaires, disease specific quality of life instruments are gradually emerging in the standards of examination and follow-up of urological patients.

Amyotrophic lateral sclerosis-specific quality of life-short form (ALSSQOL-SF): A brief, reliable, and valid version of the ALSSQOL-R.

The Amyotrophic Lateral Sclerosis (ALS)-Specific Quality of Life instrument and its revised version (ALSSQOL and ALSSQOL-R) have strong psychometric properties, and have demonstrated research and clinical utility. In this study we aimed to develop a short form (ALSSQOL-SF) suitable for limited clinic time and patient stamina. The ALSSQOL-SF was created using Item Response Theory and confirmatory factor analysis on 389 patients. A cross-validation sample of 162 patients assessed convergent, divergent, and construct validity of the ALSSQOL-SF compared with psychosocial and physical functioning measures. The ALSSQOL-SF consisted of 20 items. Compared with the ALSSQOL-R, optimal precision was retained, and completion time was reduced from 15-25 minutes to 2-4 minutes. Psychometric properties for the ALSSQOL-SF and its subscales were strong. The ALSSQOL-SF is a disease-specific global QOL instrument that has a short administration time suitable for clinical use, and can provide clinically useful, valid information about persons with ALS. Muscle Nerve 58: 646-654, 2018.