Quality Of Life Instruments Research Articles

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.

The Personalized Priority and Progress Questionnaire (PPPQ): A personalized instrument for quality of life and self-management for use in clinical trials and practice

PurposeThe aim of this study was to develop and validate a brief personalized instrument that (1) defines patients’ priorities for improvement, (2) measures progress in prioritized quality of life (QoL) and self-management outcomes, and (3) is applicable in both clinical practice and clinical trials.MethodsThe instrument was developed based on the literature on personalized assessment and patient priorities, feedback by clinicians, and six cognitive interviews with patients with chronic kidney disease. The resulting questionnaire, the Personalized Priority and Progress Questionnaire (PPPQ), contains a baseline and follow-op measurement. The baseline measurement assesses functioning on QoL (8 items) and self-management (5 items). The final item evaluates patients’ priorities for improvement. The follow-up measurement assesses progress in QoL and self-management. A personalized progress score can be calculated indicating the amount of progress on the QoL or self-management domain that is prioritized by the individual patient. Psychometric properties of the PPPQ were evaluated among patients with chronic kidney disease (n = 121) and patients with kidney failure treated with dialysis (n = 22).ResultsThe PPPQ showed to be a feasible instrument that is easy and quick to complete. Regarding the construct validity, small to large correlations were found between the items and existing validated questionnaires measuring related constructs.ConclusionThe PPPQ proved to be a feasible and valid instrument. The PPPQ can be adapted to match diverse populations and could be a useful tool both in clinical practice (e.g., to identify priorities and tailor treatment) and clinical trials (e.g., to evaluate the effectiveness of personalized interventions).

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 < EORTC QLQ-C30 < SF-36v2 and were equal to 105 s < 213 s < 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.

Validation of the Slovakian Version of the "Post‑acute (Long) COVID‑19 Quality of Life Instrument" and Pilot Study.

The aim of our study was to validate a Slovakian translation of the PAC‑19QoL instrument among Slovakian patients with post COVID-19 syndrome. The PAC-19QoL instrument was translated into the Slovakian language and administrated to patients with post COVID-19 syndrome. Cronbach's alpha coefficient was used to analyse the internal consistency of the instrument. Construction validity was evaluated by using Pearson's correlation coefficient and Spearman's rank correlation. Scores of patients and controls were compared using Mann-Whitney U-test. Forty-five asymptomatic and forty-one symptomatic participants were included. Forty-one patients with post COVID-19 syndrome completed the PAC-19QoL and EQ-5D-5L questionnaires. PAC-19QoL domain scores were significantly different between symptomatic and asymptomatic participants. All items achieved a Cronbach alpha greater than 0.7. There was a significant correlation between all domains on the test (p < 0.001), with the highest correlation of Total (r = 0.994) and Domain 1 (r = 0.991). Spearman's rank correlation analysis confirmed that the instrument items correlated with the objective PAC-19QoL examination findings. The Slovakian version of the instrument is valid, reliable and can be a suitable tool for research and daily clinical practice among patients with post COVID-19 syndrome.

Improved health-related quality of life after hepatitis C viraemic clearance among people who inject drugs may not be durable.

Chronic infection with the hepatitis C virus (HCV) has a detrimental impact on health-related quality of life (QoL). Scale-up of HCV direct-acting antiviral (DAA) therapy among people who inject drugs (PWID) is underway in several countries since the introduction of interferon-free regimens. This study aimed to assess the impact of DAA treatment success on QoL for PWID. Cross-sectional study using two rounds of the Needle Exchange Surveillance Initiative, a national anonymous bio-behavioural survey and a longitudinal study involving PWID who underwent DAA therapy. The setting for the cross-sectional study was Scotland (2017-2018, 2019-2020). The setting for the longitudinal study was the Tayside region of Scotland (2019-2021). In the cross-sectional study PWID were recruited from services providing injecting equipment (n = 4009). In the longitudinal study, participants were PWID on DAA therapy (n = 83). In the cross-sectional study, the association between QoL (measured using the EQ-5D-5L quality of life instrument) and HCV diagnosis and treatment was assessed using multilevel linear regression. In the longitudinal study, QoL was compared at four timepoints using multilevel regression, from treatment commencement until 12 months following commencement. In the cross-sectional study, 41% (n = 1618) were ever chronically HCV infected, of whom 78% (n = 1262) were aware of their status and of whom 64% (n = 704) had undergone DAA therapy. There was no evidence for a marked QoL improvement associated with viral clearance among those treated for HCV (B = 0.03; 95% CI, -0.03 to 0.09). In the longitudinal study, improved QoL was observed at the sustained virologic response test timepoint (B = 0.18; 95% CI, 0.10-0.27), but this was not maintained at 12 months following start of treatment (B = 0.02; 95% CI, -0.05 to 0.10). Successful direct-acting antiviral therapy for hepatitis C infection may not lead to a durable improvement in quality of life among people who inject drugs, although there may be a transient improvement around the time of sustained virologic response. Economic models of the impact of scaling-up treatment may need to include more conservative quality of life benefits over and above reductions in mortality, disease progression and transmission of infection.

Quality of Life of the Blind: Looking through a Wider “Lens” Beyond the Medical “Eye”

Over one-fourth of the global population experience Visual Impairment and Blindness (VI&amp;B) where they often experience significant challenges than those who can 'see'. Despite the subject of Quality of Life (QoL) being extensively researched, there is little or no focus on explaining this concept as applicable to persons with VI&amp;B. Furthermore, there is no unified characterization of QoL as a construct although diverse views have been presented in general. This paper seeks to explore the concept of QoL in the specific domain of persons with VI&amp;B. In the process, a comprehensive literature search was carried out using multiple electronic databases where 239 publications were consulted. Selected papers were subjected to a content analysis to identify conceptual and measurement principles pertaining to their QoL. The existing vision-specific QoL instruments are mostly domain specific and focus on the medical aspect of a life of quality, disregarding the influence of environmental and personal factors that contribute to their well-being. Results of the analysis pointed to the fact that QoL of persons with VI&amp;B should draw attention to their specific needs, expectations, and values, where a comprehensive characterization that encompasses physical, psychological, social, material, and environmental aspects, along with an evaluation of the individual’s participation, autonomy, personal development, and the impact of vision requires to be explored. This multi-dimensional conceptual model could be used as the basis for the development of a new measure for the assessment of overall quality of life for persons with VI&amp;B.

Audiometric and Patient-Reported Outcomes in Single-Sided Deafness Cochlear Implant Recipients Using the CIQOL-35.

Describe the effect that cochlear implantation (CI) hason audiometric outcomes and quality of life (QOL) in patients with single-sided deafness (SSD). Retrospective case review. Tertiary university hospital system. Preoperative and postoperative AzBio performance and Cochlear Implant Quality of Life-35 (CIQOL-35) Profile scores in CI patients with SSD were compared, and postoperative measures were compared to those from CI patients without SSD. Seventeen patients with unilateral CI and contralateral unaided pure-tone averages ≤30 dB were included. The median age was 60.2 (interquartile range [IQR], 50.9-64.9 years), and 7/17 (41%) were women. Median daily use was 8.2 hour (IQR, 5.4-11.9 h). The median preoperative AzBio quiet score in the ear to be implanted was 3% (IQR, 0%-6%). After a median follow-up of 12.0 months, the median postoperative AzBio quiet score was 76% (IQR, 47%-86%) (p < .01). SSD subjects demonstrated statistically significant improvements in median scores on the following CIQOL-35 subdomains following implantation: Entertainment (17 preoperatively vs21 postoperatively), Listening Effort (12 vs 14), Social (17 vs 22), and Global (28 vs 35; p < .05). SSD patients achieved equal or higher postoperative CIQOL-35 scores in most subdomains (6/7) compared to an age-matched group of non-SSD CI recipients who underwent unilaterally (N = 19) or sequential (N = 6) implantation. SSD CI patients not only demonstrate significant improvements in speech perception testing in the implanted ear but also exhibit improvement in multiple QOL subdomains on the CIQOL-35, the only validated cochlear implant QOL instrument.

Quality of life in Hidradenitis Suppurativa (Acne Inversa): A scoping review.

Hidradenitis Suppurativa (HS) is a chronic, relapsing, inflammatory skin condition which is physically, psychologically and socially disabling and often affects a patient's quality of life (QOL). There are numerous QOL tools used in dermatology. However, assessment of QOL in patients with HS is difficult due to the inability of generic QOL tools to specifically capture QOL in patients with HS. Numerous HS-specific QOL tools have been developed in recent years. It is important to identify evidence on full psychometric evaluation of these tools. There has been a gradual increase in the use of generic and disease-specific QOL tools in the last few decades. The aim of this scoping review (SR) is to evaluate the most widely used generic QOL tools and HS-specific QOL tools to identify the psychometric evaluation of such tools. Design: An SR guided by Joanna Briggs Institute manual and Arskey O'Malley framework guidelines. Data extraction included the studies available on full psychometric evaluation of the most widely used dermatology generic QOL tools in HS and HS-specific QOL tools. Ten papers were included in the review, eight papers demonstrated HS-specific QOL assessment tools. The psychometric properties of these tools were underpinned by reliability, validity and sensitivity measurement. Six disease-specific tools were identified in this SR. However, they all lack full psychometric evaluation. This review indicates that an extensive research in the field of QOL tools for HS is much needed. It is crucial to develop user-friendly and validate disease-specific tools to measure the real impact of disease on patients QOL. QOL instruments can evaluate the impact on life of an HS patient, thus helping improve intervention and management of disease. There is a necessity for more research into existing HS-specific QOL tools and they should be widely tested and fully validated.

Correlation between Generic and Disease-Specific Quality of Life Questionnaires in Patients with Venous Ulcerations: A Cross-Sectional Study Carried out in a Primary Health Care Setting in Brazil.

Venous Ulcers (VU) are a serious health problem that affect the Quality of Life (QoL). They are evaluated by many different scales in the literature. We aimed to analyze the correlation between the Medical Outcomes Short-Form Health QoL (SF-36) and Charing Cross Venous Ulcer Questionnaire (CCVUQ) scales. This is a cross-sectional study conducted in a Brazilian center specializing in chronic VU of the Primary Health Care (PHC) provided to patients with active VU. The general QoL instrument SF-36 and the CCVUQ, specific for people with VU, were used. Spearman's Rho Test determined the correlation between the variables analyzed. Our sample had a total of 150 patients. We found a direct correlation between the domestic activities division (CCVUQ) aspect and the SF-36 Physical role functioning (strong), and Physical functioning (moderate) domains. The Social interaction division (CCVUQ) aspect presented moderate correlation with the domains of the SF-36 Physical role functioning and Physical functioning. The Vitality domain (SF-36) showed moderate correlation with the aspects of CCVUQ Cosmesis division and Emotional status division. The greatest forces of direct correlation were observed between the physical, functional and vitality aspects of SF-36 with those represented by domestic activities and social interaction in the CCVUQ.

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.

DOP23 Decrements in quality of life associated with symptoms of Inflammatory Bowel Disease: results from the UK IBD-BOOST survey

Abstract Background Inflammatory Bowel Disease (IBD) affects about 7 million people worldwide. People with active disease often experience symptoms of abdominal pain, fatigue and incontinence which may persist even in remission. We assess the impact of these symptoms, and the further contribution of anxiety and depression, on health-related quality of life (QoL) of people with IBD. Methods In the IBD-BOOST survey, over 12,500 people with IBD in the UK were approached across outpatient clinics, the IBD-BioResource participants and the Crohn’s and Colitis UK charity membership; 8486 self-completed surveys were returned. Participants’ QoL was measured using the EQ-5D-5L questionnaire, a generic health-related QoL instrument. Patients’ QoL, ranging from 1 (perfect health) to -0.594 (worst health) was calculated using UK value set. Our approach involved three pre-specified stages of linear regression model development to assess the effects of symptoms on QoL. At stage 1 the model included IBD type, IBD activity score, IBD control score, socio-demographic characteristics and co-morbidities. At stage 2, the three key IBD symptoms: pain, fatigue and bowel incontinence were added. At stage 3, anxiety and depression were also included. Results Table 1 presents selected characteristics of the 8486 IBD-BOOST survey participants (mean age 50 years, 58% women, 49% Crohn’s disease). The EQ-5D-5L questionnaire was completed by 8114 (96%) participants reporting problems across QoL domains (Figure 1: 30% problems with mobility, 13% with self-care, 43% with usual activities, 60% pain/discomfort and 50% anxiety/depression). The mean QoL was 0.76 (SD 0.22). Health-related QoL was substantially reduced in respondents reporting higher IBD activity or worse IBD control (Table 2; stage 1). These associations weakened substantially following adjustment for the key IBD symptoms of pain, fatigue and bowel incontinence for which strong and graded associations with higher symptom severity associated with lower QoL were observed (Table 2; stage 2). The further inclusion of adjustments for anxiety and depression only moderately weakened previous associations and strong and graded associations between more severe anxiety or depression and lower QoL were also observed (Table 3; stage 3). Being male, obese, unemployed/retired, or having physical or mental health comorbidity were associated with lower QoL, and being in a relationship with higher QoL (results not shown). Conclusion We report graded associations between symptoms of pain, fatigue, bowel incontinence, anxiety and depression and QoL in IBD. These estimates could inform assessments of interventions to improve IBD management.

Examining the feasibility of adult quality-of-life measurement for obstructive sleep apnea in clinical settings: what is the path forward for sleep centers?

Colvin L, Collop N, Lorenz R, Morgenthaler T, Weaver TE. Examining the feasibility of adult quality-of-life measurement for obstructive sleep apnea in clinical settings: what is the path forward for sleep centers? J Clin Sleep Med. 2023;19(6):1145-1155.

Clinical and sociodemographic factors associated with the quality of life of children and adolescents with type 1 diabetes.

To analyze clinical and sociodemographic factors associated with the health-related quality of life of children and adolescents with type 1 Diabetes Mellitus. A quantitative, cross-sectional and analytical study, developed in a municipality in northeastern Brazil, between March and September 2021, with 81 children/adolescents with type 1 Diabetes Mellitus and their guardians/caregivers. A questionnaire containing sociodemographic and clinical variables and two quality of life instruments were used. Descriptive and inferential analysis was carried out. Adolescents whose parents had a family income greater than a minimum wage had a lower prevalence of impaired quality of life when compared to those with a lower income. Adolescents with time since diagnosis of less than four years had a satisfactory quality of life, and children aged 8 to 12 years who self-administered insulin had a lower prevalence of high quality of life compared to those who did not. Adolescents with a family income of less than a minimum wage, diagnosis time of more than four years and children aged 8-12 who self-administer insulin need greater professional support to have a better quality of life.

Patient‐reported outcomes post prophylactic risk‐reducing mastectomy: improved breast and psychosocial satisfaction yet poorer physical well‐being

Few studies have investigated patient-reported outcomes (PROs) for patients with high breast cancer risk undergoing elective risk reduction mastectomy and reconstruction. These patients incur operative risk in the absence of active cancer, which renders their treatment experience unique. This study aimed to identify longer-term quality of life (QoL) issues that persist in this patient cohort. A cross-sectional cohort study assessed PROs in 48 women with high breast cancer risk who attended the Royal Melbourne Hospital Risk Management Clinic, at least 12 months post-mastectomy and reconstruction, with surgery between 2011 and 2020, using the BREAST-Q© Likert surveys. The BREAST-Q© internationally validated QoL instrument scales survey data from 0 (worst) to 100 (best) in 14 domains addressing satisfaction and psychosocial issues. There was higher overall breast and psychosocial satisfaction, with scores of 11 and four, respectively, yet lower chest, abdomen and sexual well-being scores with 14, three and four, respectively, in contrast to normative BREAST-Q© data from >1000 women without prior breast cancer or breast operations. High average scores >90 were found for patient satisfaction with surgical, medical and office staff. Twenty-one patients had an average score of 63 for satisfaction with breast implants, while 27 patients post-DIEP had average scores >72 for abdominal well-being, appearance and overall outcomes. Higher mean QoL outcomes were found with DIEP flap in all domains, compared with breast implant reconstruction. QoL assessment with PROs 12 months post-risk reduction mastectomy and reconstruction demonstrated higher psychosocial well-being, yet highlights physical implications, with patients experiencing reduced chest, abdomen and sexual well-being, compared with normative BREAST-Q© control data. Higher mean QoL outcomes were found with DIEP flap compared with breast implant reconstruction. PROs studies can identify unmet needs and facilitate change in service provision.

Chronic physical conditions, physical multimorbidity, and quality of life among adults aged ≥ 50 years from six low- and middle-income countries

PurposeMultimorbidity (i.e., ≥ 2 chronic conditions) poses a challenge for health systems and governments, globally. Several studies have found inverse associations between multimorbidity and quality of life (QoL). However, there is a paucity of studies from low- and middle-income countries (LMICs), especially among the older population, as well as studies examining mediating factors in this association. Thus, the present study aimed to explore the associations, and mediating factors, between multimorbidity and QoL among older adults in LMICs.MethodsCross-sectional nationally representative data from the Study on Global Ageing and Adult Health were analyzed. A total of 11 chronic conditions were assessed. QoL was assessed with the 8-item WHO QoL instrument (range 0–100) with higher scores representing better QoL. Multivariable linear regression and mediation analyses were conducted to assess associations.ResultsThe final sample consisted of 34,129 adults aged ≥ 50 years [mean (SD) age 62.4 (16.0) years; age range 50–114 years; 52.0% females]. Compared to no chronic conditions, 2 (b-coefficient − 5.89; 95% CI − 6.83, − 4.95), 3 (− 8.35; − 9.63, − 7.06), 4 (− 10.87; − 12.37, − 9.36), and ≥ 5 (− 13.48; − 15.91, − 11.06) chronic conditions were significantly associated with lower QoL, dose-dependently. The mediation analysis showed that mobility (47.9%) explained the largest proportion of the association between multimorbidity and QoL, followed by pain/discomfort (43.5%), sleep/energy (35.0%), negative affect (31.9%), cognition (20.2%), self-care (17.0%), and interpersonal activities (12.0%).ConclusionA greater number of chronic conditions was associated with lower QoL dose-dependently among older adults in LMICs. Public health and medical practitioners should aim to address the identified mediators to improve QoL in patients with multimorbidity.

What Quality-of-Life Dimensions Are Most Important to Older Adults from Culturally and Linguistically Diverse Backgrounds Receiving Aged Care Services? An Exploratory Study.

There is little research on what aspects of quality of life (QoL) are most important to culturally and linguistically diverse (CALD) older adults. This study aimed to identify what QoL dimensions were most important to CALD older adults receiving aged care services, and therefore, how relevant a new six dimensions QoL instrument developed for use in aged care is to this population. A three-stage, mixed-methods study was undertaken. Stage 1: n = 3 focus groups with aged care providers. Stage 2: n = 30 semi-structured interviews with Italian-born older adults in ethno-specific residential aged care. Stage 3: survey of n = 63 older adults from mixed CALD backgrounds receiving community aged care services. Overall, older adults asserted the importance of the six dimensions of the new QoL instrument. The importance of 'identity' and 'purpose and meaning' were identified via the focus groups; however, the community-based CALD older adults identified these aspects of quality of life as more important than older Italians in residential care. Being in ethno-specific residential aged care where needs relating to language, food, and religion were met and they continued to live with others from their community may have meant that the meeting of cultural needs was more taken for granted.

Early Experience and Patient Characteristics from Opera: A Real-World Study of Pegcetacoplan Treatment

Background Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, acquired life-threatening disease characterized by complement-mediated hemolysis and thrombosis. Chronic hemolysis leads to anemia, which can result in persistent fatigue and dependance on transfusions, affecting the overall quality of life (QOL) of patients with PNH. Pegcetacoplan (PEG; US brand name Empaveli®) is the first approved C3 inhibitor for US adults with PNH. Although clinical trials have assessed the efficacy of PEG, which include patient-reported outcomes, there is no information on the use of PEG in a real-world setting. Aims To provide the first report of trends in hemoglobin (Hb) values and baseline QOL (measured by patient-reported fatigue and cognitive impairment) from OPERA, a descriptive, observational exploratory outcomes study, presenting the first real-world data describing PEG treatment for adults with PNH post-approval. Methods This single site opt-in study recruited patients in the US, following a valid PEG prescription from a licensed medical professional. Patients ≥18 years of age, diagnosed with PNH and prescribed PEG, were electronically consented and then enrolled to participate in the OPERA study, as approved by the internal review board. OPERA collected information from routine care and did not direct or suggest any medical interventions. In this observational setting, Hb lab values were reported (by the patient/site) at varying timepoints when available. Participants self-reported QOL status from baseline over a 12-month period through monthly phone calls and quarterly online patient-reported outcome measures (PROMs). During monthly phone calls, participants were asked to report their most recent Hb levels (typical normal range: male, 13.6-18 g/dL; female, 12-16 g/dL) if available from their regular primary care visits in the previous month. Online PROMs collected data using validated QOL instruments including the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale (0-52 total score) and the Patient-Reported Outcomes Measurement Information System (PROMIS) scale for Cognitive Abilities (23.27-67.09 t-score). Lower scores on each measure represent greater levels of fatigue or cognitive impairment. Results Participants enrolled in OPERA with a 30-70% monthly range to opt-in. Of 17 participants enrolled with available baseline Hb values, mean (range) age was 45.76 (20-70) years, and 8 were female. No OPERA participants were previously enrolled in a PEG clinical trial. All participants were prescribed and received the label recommended dose of PEG (1080 mg, twice weekly). All participants reported prior treatment with either eculizumab, ravulizumab or both, before starting PEG. Additional dosing information and time since PNH diagnosis can be found in the Table. The mean (SD) baseline Hb levels from 17 OPERA participants was 8.90 (2.19) g/dL, which was similar to the mean (SD) baseline Hb levels (8.69 [1.08] g/dL) for 41 patients in the previously published phase 3 PEGASUS (NCT03500549) trial. Among 4 participants with available data after 1 month of PEG use, mean (SD) Hb levels increased to 11.95 (1.84) g/dL (mean change from baseline +2.83 (1.35) g/dL) which was similar to the mean (SD) Hb levels of 11.55 (1.62) g/dL seen in 40 PEGASUS participants after 1 month of treatment. QOL data was available at baseline in 12 participants and the mean (SD) baseline FACIT-Fatigue score was 30.25 (15.63), which was similar to the mean (SD) baseline FACIT-Fatigue score of 32.2 (11.4) from the PEGASUS trial, but below the reported mean FACIT-Fatigue population norm of 43.6 (Cella, et al. Cancer. 2002). Additionally, the mean (SD) PROMIS-Cognitive Abilities t-score for patients with available QOL data (n=12) was 43.57 (9.11), which is lower than the published population norm of 50 (Saffer, et al. Psychiatry Research 2015). Conclusions This first real-world study of adults with PNH receiving PEG indicates a positive trend in Hb levels in participants after 1 month of use. These early experiences are similar to previously reported changes in Hb levels after PEG treatment in phase 3 clinical trials (Hillmen et al, NEJM 2021). At baseline, participants with PNH report a considerable amount of fatigue and cognitive impairment, indicating poor QOL with previous C5 inhibitor treatment. More research is needed to corroborate the findings of this first analysis. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Cochlear implant-specific risks should be considered, when assessing the quality of life of children and adolescents with hearing loss and cochlear implants-not just cochlear implant-specific benefits-Perspective.

Cochlear implants (CIs) are electronic medical devices that enable hearing in cases where traditional hearing aids are of minimal or no use. Quality of life (QoL) studies of children and adolescents with a CI have so far focused on the CI-specific benefits. However, the CI-specific risks listed by the U.S. Food and Drug Administration have not yet been considered. From this list, medical and device-related complications, lifelong dependency on the implanted device, and neurosecurity risks (CI technology is an interface technology) may be particularly relevant for young CI users. Medical and device-related complications can cause physical discomfort (e.g., fever, pain), as well as functioning problems (e.g., in speech discrimination, social behavior, and mood). In the worst case, reimplantation is required. Clinical experience shows that these complications are perceived as a burden for young CI users. Furthermore, many young patients are worried about possible complications. Additionally, CIs can be at least a temporary burden when children, typically at the age of 8-9 years, realize that they need the CI for life, or when they become peer victims because of their CI. Concerning neurosecurity risks, it is still unknown how young CI recipients perceive them. In summary, CI-specific risks can be perceived as a burden by young CI users that impairs their QoL. Therefore, they should not be ignored. There is an urgent need for studies on this topic, which would not only be important for professionals and parents, but also for the design of CI-specific QoL instruments.

Care home staff perceptions of implementing a quality of life instrument into routine care practice: A qualitative study.

Quality of life is an important outcome in older-adult care. Measuring resident quality of life may offer ways to improve it and to improve quality of care. However, in the UK quality of life is rarely measured as a part of routine care. Our study aimed to understand the views of care home staff about using a quality of life instrument as a part of routine care in order to support its implementation into routine practice. In a qualitative study, we conducted 35 interviews with care home staff and two focus groups with four care home managers from three care homes in East Sussex, England. Data were collected between September 2015 and February 2016. Care staff and managers were aged on average 40 (SD=12.2) and 43.7 (SD=14.4) years and had worked in the care sector an average of 11.4 (SD=10.2) and 23.7 (SD=14.1) years, respectively. Participants were predominantly female and white British. Interviews and focus groups were analysed using thematic analysis. Findings identified two overarching themes of 'Perceived gains' and 'Implementation'. Overall, there was a lot of positivity towards using a quality of life instrument in routine practice. This positivity was an important feature in how the instrument was perceived as fitting into practice. Participants identified several barriers and discussed how to overcome them. Results from the study demonstrate that routine measurement of quality of life is positively received by care staff. They believed that measuring quality of life as a part of care practice could lead to improvements in resident quality of life, staff knowledge and understanding and care practices. The findings suggest that routinely measuring quality of life as a part of normal care could also have more far-reaching effects on the provision of person-centred care provided by care staff.

The power of spirituality in symptomatic and functional outcomes of patients with major depressive disorder in an Egyptian sample

ABSTRACT Assessing the role of spirituality on outcomes in Arab patients with major depressive episode and the possible confounding factors is lacking. The aim of the present study was to determine whether spirituality was associated with symptomatic and functional outcomes in an outpatient facility. A total of 79 participants were consecutively enrolled in this study who presented to a psychiatry outpatient clinic over the course of two years. Baseline and follow-up variables were collected via direct interviews of the patients and their caregivers. In order to assess symptomatic outcome, Hamilton Depression Rating Scale (HAMD) is used monthly over 6 months and its percent of reduction is used as an indicator for symptomatic outcome, functional outcome was measured by the percentage of reduction of both scales (WHO Disability Assessment Schedule (WHODASII) and WHO Quality of Life instrument (WHOQOL-100)) that were administrated twice at baseline interview then after 6 months of follow-up (final interview), while spirituality of the sample was measured by using Daily Spiritual Experience Scale (DSES) which assess the intrinsic Spirituality, it is a 16-item self-report measure designed to assess ordinary experiences of connection with the transcendent in daily life. Spirituality was significantly correlated to the disability scale percentage reduction (p = .003), while no significant relation between Spirituality with symptomatic outcome nor the quality of life aspect of functional outcome (p = .259) and (p = .134), respectively. Demonstrating a relationship between spirituality and functional outcome would suggest a new therapeutic route of improving interventions designed to increase outcome and improve quality of life and functioning for Arab patients with major depression.