Generic Health-related Quality Of Life Tool Research Articles

Health-related quality of life and its influencing factors in patients with primary cutaneous B-cell lymphomas: A multicentric study in 100 patients.

Primary cutaneous B-cell lymphomas (CBCL) are a group of rare malignant skin diseases that represent approximately 20%-30% of all primary cutaneous lymphomas (PCL). Previous studies revealed impaired health-related quality of life (HRQoL) in patients diagnosed with primary cutaneous T-cell lymphoma (CTCL). Currently, only small-sized studies investigated HRQoL in CBCL patients and lacked detailed analysis of respective subtypes. This study aims to investigate HRQoL in CBCL patients to identify independent factors of HRQoL impairment in CBCL patients. One hundred CBCL patients were recruited from eight German PCL centres in this multicentric, cross-sectional study from 2021 to 2022. The patients completed the dermatologic HRQoL questionnaire Skindex-29 and an investigator-designed 'CBCL-Questionnaire' with additional questions on HRQoL and clinical characteristics. The Skindex-29 revealed that HRQoL in CBCL patients is impaired on a mild to moderate level. The multiple regression analysis identified parameters like worries about dying, feeling prejudiced/discriminated and impairment of daily activities to be independently associated with impairment of HRQoL. Highest scores for HRQoL impairment were found in patients with primary cutaneous follicle centre lymphoma while on rituximab treatment and in patients with primary cutaneous marginal zone lymphoma while on watchful waiting. HRQoL is impaired in CBCL patients, even though, in the face of indolent disease course and favourable prognosis in the majority of cases. Of note, our investigator-designed tool identified worries about dying, feeling prejudiced/discriminated, and the type of treatment to have a negative impact on patients' HRQoL. Our study highlights the importance of a thorough patient-doctor communication to capture overall disease burden because generic HRQoL tools might lack of disease-specific items.

Dyspnea Associates With a Widely Impaired Quality of Life in Idiopathic Pulmonary Fibrosis Patients: A Longitudinal Study Using 15D.

Background: Research on health-related quality of life (HRQoL) is crucial for developing comprehensive palliative care in idiopathic pulmonary fibrosis (IPF). Objectives: To study IPF patients' HRQoL compared with general population and its association with dyspnea in a longitudinal follow-up. Design: Assessment of IPF patients' HRQoL by a generic tool. Comparison of baseline data with the general population and a 30-month follow-up with 6 months intervals. Setting/Subjects: In total, 246 IPF patients were recruited from the Finnish nationwide real-life study, FinnishIPF. Measurements: Modified Medical Research Council (MMRC) dyspnea scale for dyspnea and the generic HRQoL tool 15D for the total and dimensional HRQoL were used. Results: At baseline, the mean 15D total score was lower (0.786, standard deviation [SD] 0.116) in IPF patients than in the general population (0.871, SD 0.043) (p < 0.001) and among the IPF patients with MMRC ≥2 compared with those with MMRC <2 (p < 0.001). In patients with MMRC ≥2, significant impairment compared with general population existed in 11 dimensions of HRQoL, such as breathing, usual activities, and sexual activity, whereas this was true in only 4 dimensions in MMRC <2 category. Mental function was not impaired in either group. During the follow-up, 15D total score decreased in both MMRC categories (p < 0.001) but stayed constantly worse in the MMRC ≥2 group. Seven and two dimensions of HRQoL significantly declined in the categories of MMRC <2 and MMRC ≥2, respectively. Conclusions: Patients with IPF, especially if dyspnea limits everyday life, suffer from widely impaired HRQoL, although self-assessed mental capability is preserved. Integrated palliative care is supported to face the multiple needs of IPF patients.

Development of a Disease-Specific Health-Related Quality of Life Questionnaire (DTF-QoL) for Patients with Desmoid-Type Fibromatosis.

Simple SummaryDesmoid-type fibromatosis (DTF) is an uncommon soft-tissue tumour that is incapable of metastasising. Patients can experience a variety of physical and psychological symptoms, making assessment of health-related quality of life (HRQoL) highly relevant. Measuring the impact of DTF on HRQoL can be challenging due to the rare character and variable clinical presentation of the disease. Therefore, a HRQoL instrument assessing DTF-specific issues is needed. Previously, a provisional DTF-specific HRQoL tool was developed (the DTF-QoL). The aim of the current study was to pre-test the DTF-QoL. Pre-testing of the questionnaire led to the selection of 96 questions, conceptualised into three symptom subscales, eleven disease-impact subscales and six single items, together forming the final DTF-QoL. This questionnaire can be used in both clinical and research settings to evaluate HRQoL of DTF patients, which could help to provide personalised care and improve overall patient experience.Sporadic desmoid-type fibromatosis (DTF) is a rare, non-metastasising soft-tissue tumour. Patients can experience a variety of disease-specific issues related to the unpredictable clinical course and aggressiveness of DTF, which negatively impacts health-related quality of life (HRQoL). These DTF-specific issues are not captured by generic HRQoL tools. A 102-item provisional DTF-specific HRQoL tool, the DTF-QoL, was previously developed. The aim of this study was to pre-test the psychometric properties of the DTF-QoL by administering it together with the EORTC Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) to 236 DTF patients from the United Kingdom and the Netherlands. Construct validity and reliability were determined based on factor analysis, multi-trait scaling analysis, Cronbach’s alpha, and correlations with the EORTC QLQ-C30 scales. Ninety-six items were selected, conceptualised into three symptom scales, eleven disease-impact scales and six single items, together forming the final DTF-QoL. Scaling assumptions were fully or moderately met for ten out of fourteen scales. Cronbach’s alpha ranged from 0.551–0.908. Most scales of the DTF-QoL were weakly or moderately correlated with the EORTC QLQ-C30. The DTF-QoL is a promising tool capturing the whole spectrum of DTF-specific issues. Implementation of the DTF-QoL in research and clinical practice will help to personalise HRQoL measurement and clinical care for DTF patients.

Validation of the Finnish version of the BODY-Q patient-reported outcome instrument among patients who underwent abdominoplasty

Massive weight loss can notably affect patients' health-related quality of life (HRQoL) and body image. Yet, no body contouring specific instruments to assess HRQoL and body image after massive weight loss have been validated in Finnish. The BODY-Q includes 26 independently functioning scales and a single checklist that measure appearance, HRQoL, and experience of care. The aim of the present study was to translate and validate a Finnish version of the BODY-Q among patients who underwent abdominoplasty. The BODY-Q was translated into Finnish using recommended guidelines. Eighty-two patients who underwent abdominoplasty due to massive weight loss were identified from hospital records using procedure codes. A postal survey including the BODY-Q, the 15D, and general health and pain instruments was used. Criterion validity, Cronbach's alpha, and floor and ceiling effects were analyzed. The BODY-Q translated well into Finnish. Fifty-three patients returned the questionnaires (response rate 65%) and were included. All but the Scars subscale correlated significantly with the 15D mean score, thus indicating strong criterion validity against a generic HRQoL tool. The Excess Skin and the Physical Function scales reached the ceiling effect (>15% of maximum points) in our postoperative sample. No floor effects were observed. Internal consistency of the BODY-Q scales was high (Cronbach's alpha range, 0.81-0.95). The Finnish version of the BODY-Q instrument is equivalent in terms of content, accuracy, and comprehensiveness to the original English version. The findings of the present study indicate that the BODY-Q has psychometric properties suitable for assessing outcomes and treatment effectiveness of abdominoplasty.

Health-related quality of life in pre-adolescent liver transplant recipients with biliary atresia: A cross-sectional study

Pediatric recipients of liver transplantation (LT) often report lower Health-Related Quality of Life (HRQOL) than healthy controls when assessed on generic HRQOL measurement tools. The recent addition of the Pediatric Liver Transplant Quality of Life (PeLTQL), a novel disease-specific HRQOL instrument for pediatric LT recipients, into the clinical armamentarium of tools now routinely available to clinical care teams, provides the unique opportunity to identify disease-related challenges in children who have undergone this life-saving intervention. This study assesses HRQOL in pre-adolescent aged patients with a primary diagnosis of biliary atresia (BA) who underwent LT as an infant, using both generic and disease-specific HRQOL instruments validated for children. We also examined modifiable factors associated with HRQOL after pediatric LT. HRQOL was the primary outcome of this study assessed using the disease-specific PeLTQL and the generic Pediatric Quality of Life Inventory 4.0 (PedsQL). Exposure variables of interest included medication status (e.g., monotherapy, dual therapy) and participation in sports. A total of 70 (56% female, mean age 9.89 ± 1.25 years) pediatric LT recipients (mean interval since LT was 9.0 ± 1.26 years) comprised the study cohort. LT recipients reported significantly lower PedsQL Scores relative to the general population. Immunosuppression monotherapy was associated with higher patient-reported PeLTQL Scores, and sports participation was associated with higher parent-reported PedsQL Scores. Pre-adolescents who underwent LT as an infant with BA, self-report low HRQOL on both disease-specific and generic HRQOL tools. Further research targeting sports participation and simplifying immunosuppression may further optimize quality of life years restored by life-saving LT.

HEALTH-RELATED QUALITY OF LIFE IN POORLY CONTROLLED TYPE 2 DIABETES PATIENTS - ASSOCIATION OF PATIENTS’ CHARACTERISTICS WITH EQ-5D DOMAINS, MEAN EQ-5D SCORES, AND VISAUL ANALOG SCALE SCORE

Objective: High prevalence of diabetes mellitus in Malaysia demands the appropriate interventions to alleviate or postpone its burden on patients’ health-related quality of life (HRQoL). The studies which provide useful knowledge about the components of such interventions are important. The aim of this study was to describe how demographic and clinical characteristics of diabetes patients influence their HRQoL using EQ-5D.Methods: This study used the baseline data of a randomized controlled study carried out to examine the impact of a pharmacist intervention on poorly controlled diabetes patients. A generic HRQoL tool EQ-5D was used to report the data. Logistic regression was used to identify the predictors of problems in individual EQ-5D domains, and ANCOVA was undertaken to examine the effect of patients’ characteristic on EQ-5D mean scores and visual analog scale (VAS) mean scores.Results: Pain discomfort was reported to be significantly predicted by high HbA1c levels. Increasing age (OR =1.04; CI 1.01, 1.16) and increasing body mass index (OR = 1.15; CI 1.01, 1.30) were significant predictors of reduced mobility. The presence of complications (OR = 8.03; CI 1.34–48.02) and (5–10 years) diabetes duration predicted the reduced score in anxiety domain (OR = 7.05; CI 1.03, 48.04). Problems in usual activities were significantly predicted by age (OR = 1.4; CI 1.01, 1.18). Self-care was not affected by any of the model covariates. Mean EQ-5D score was (0.89; CI 0.85, 0.92) significantly predicted by HbA1c values (p=0.04). Mean VAS score (70.54) was significantly lower in the group receiving insulin (69.46; CI 73.74, 84.02) than the oral diabetes medication (78.88; CI 64.94, 73.98) (p=0.009).Conclusion: Patients’ characteristics were significantly associated with the HRQoL in type 2 diabetes. There was a significant and inverse association of HRQoL with medication group (insulin use), high HbA1c, obesity, and presence of complications.

HEALTH-RELATED QUALITY OF LIFE IN POORLY CONTROLLED TYPE 2 DIABETES PATIENTS - ASSOCIATION OF PATIENTS’ CHARACTERISTICS WITH EQ-5D DOMAINS, MEAN EQ-5D SCORES, AND VISAUL ANALOG SCALE SCORE

Objective: High prevalence of diabetes mellitus in Malaysia demands the appropriate interventions to alleviate or postpone its burden on patients’ health-related quality of life (HRQoL). The studies which provide useful knowledge about the components of such interventions are important. The aim of this study was to describe how demographic and clinical characteristics of diabetes patients influence their HRQoL using EQ-5D.Methods: This study used the baseline data of a randomized controlled study carried out to examine the impact of a pharmacist intervention on poorly controlled diabetes patients. A generic HRQoL tool EQ-5D was used to report the data. Logistic regression was used to identify the predictors of problems in individual EQ-5D domains, and ANCOVA was undertaken to examine the effect of patients’ characteristic on EQ-5D mean scores and visual analog scale (VAS) mean scores.Results: Pain discomfort was reported to be significantly predicted by high HbA1c levels. Increasing age (OR =1.04; CI 1.01, 1.16) and increasing body mass index (OR = 1.15; CI 1.01, 1.30) were significant predictors of reduced mobility. The presence of complications (OR = 8.03; CI 1.34–48.02) and (5–10 years) diabetes duration predicted the reduced score in anxiety domain (OR = 7.05; CI 1.03, 48.04). Problems in usual activities were significantly predicted by age (OR = 1.4; CI 1.01, 1.18). Self-care was not affected by any of the model covariates. Mean EQ-5D score was (0.89; CI 0.85, 0.92) significantly predicted by HbA1c values (p=0.04). Mean VAS score (70.54) was significantly lower in the group receiving insulin (69.46; CI 73.74, 84.02) than the oral diabetes medication (78.88; CI 64.94, 73.98) (p=0.009).Conclusion: Patients’ characteristics were significantly associated with the HRQoL in type 2 diabetes. There was a significant and inverse association of HRQoL with medication group (insulin use), high HbA1c, obesity, and presence of complications.

A Real-World Evidence Systematic Literature Review of Health-Related Quality of Life, Costs and Economic Evaluations in Newly-Diagnosed Multiple Myeloma Patients

IntroductionCurrent treatment for multiple myeloma (MM) is not curative, but aims to provide patients with improved disease control to extend survival. Newly diagnosed MM (NDMM) can have significant implications on the health-related quality of life (HRQoL) of a patient and increase the economic burden to both the patient and healthcare system. Strict protocols followed for clinical trials mean results seen in clinical trials may not reflect routine clinical practice. To assess the burden of illness of NDMM, systematic reviews of real-world humanistic and economic data was conducted.MethodsTwo systematic literature reviews (SLRs) of the humanistic and economic burden in NDMM were conducted, covering the published literature from Jan 2007 to June 2016. Data sources reviewed included Medline, Embase, PubMed (for e-publications ahead of print), and select hematology, oncology and health services research conferences. Eligibility criteria were limited to NDMM patients receiving first-line treatment (including induction, stem cell transplant [SCT], consolidation, and maintenance therapy) reported in observational studies or cost effectiveness analysis (CEA).ResultsEleven studies met the inclusion criteria for the HRQoL SLR and 29 studies for the economic SLR. The study populations were heterogeneous in terms of patient and clinical characteristics (Table 1).A summary of HRQoL measures and baseline values are shown in Table 2. Cancer or myeloma specific tools were used to assess HRQoL in 5 studies; 2 studies utilized a generic HRQoL tool (EQ-5D and SF-36). Symptoms of interest associated with MM and MM treatment - either pain, fatigue, or neuropathy - were assessed in 8 of the included studies.The humanistic burden was pronounced in patients with NDMM. Across studies, HRQoL was poor at diagnosis; the European Organization for Research and treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) global scores ranged from 55 to 64 at diagnosis (scale from 0-100 with higher values indicating better HRQoL), and improved as patients received therapy. Domains related to physical attributes, including symptoms, were more adversely affected than those related to mental domains. Pain and fatigue were consistently highlighted as the most problematic symptoms throughout the treatment period; however, both symptoms improved over the course of therapy. Neuropathy was measured in 3 studies, each in selected populations; patients who were ineligible for SCT reported greater burden due to neuropathy, and neuropathy increased over the course of first-line treatment. Financial difficulties also contributed to impairment on HRQoL for patients throughout the measured period.Of the 29 studies identified as eligible for the economic review, 22 included either direct or indirect costs, and 7 studies were CEA; 11 studies included estimates of real-world resource use. Costs varied across studies, mainly due to different cost inputs considered and currencies reported. Overall, direct costs ranged from 7,534 USD 2014 per patient per month (unadjusted medical and pharmacy costs for 1st line lenalidomide treatment) to 213,166 USD 2014 per patient (direct costs associated with autologous SCT and one year follow-up). The primary cost drivers of direct medical costs were largely medical care, including hospitalizations and ambulatory care. Two studies reported out-of-pocket expenses, ranging from 3,478 USD 2013 (annual cost to patient in 1st year after diagnoses) to 4,666 USD (year not reported; per treatment episode for 1st year after treatment initiation). The results from the CEA studies differed significantly (Table 3).ConclusionsMM specific HRQoL measures indicate reduced HRQoL at diagnosis which gradually improves throughout the treatment period in newly diagnosed patients (before they experience relapse). Pain, fatigue and financial difficulties were domains reported as problematic to patients. Resource use burden studies primarily reported in- and out-patient visits. Indirect costs were reported to be as high as 4,666 USD, which further supports the financial difficulties reported in the HRQoL studies. The burden of NDMM for a patient is physical, emotional, and financial. Real-world evidence on HRQoL and economic outcomes reported from the patient perspective is complementary to evidence from clinical trials and provides an insight into the burden of NDMM. [Display omitted] [Display omitted] [Display omitted] DisclosuresYong:Takeda: Employment. Korol:ICON plc: Employment. Khan:ICON plc: Employment. Lin:Takeda: Employment. Thompson:Takeda: Consultancy. Valovicova:Takeda Pharmaceutical Company Ltd: Consultancy. Luptakova:Takeda Oncology: Employment. Seal:Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited: Employment, Equity Ownership.

PDB39 - Increasing Trend Of Health Related Quality Of Life Awareness For Diabetic Care Among Indian Scientists

The health related quality of life (HRQoL) focused research in developing countries is scanty and far between, where 80% of healthcare cost is borne by the patient. Indian patients have different social, socioeconomic and personal outlook, therefore the HRQoL results from the western studies cannot be directly extrapolated to Asian populations. This study was conducted to make an assessment of the trends in HRQoL research in patients with diabetes in India and Asia vis-à-vis the western population. We performed literature searches in Pubmed, Clinicaltrials.gov and country-specific registries for 1985–2016 to identify studies investigating HRQoL in patients with diabetes and compared these with those for the US and the UK. Only 46 publications were identified from India, followed by Malaysia (31) and Singapore (25), which, respectively, make only 3.8, 2.5 and 2.0% of that published from USA. The contribution from Bangladesh, Pakistan, Indonesia, Philippines, Sri Lanka and Thailand was negligible. The increasing sensitivity of Indian scientists towards QoL was evident from the increasing number of publications over the years. The number of papers published for Indian populations increased from 2 in 1991-95 and 1996-2000, 4 in 2001-2005 and 7 in 2006-2010 to 31 in 2011-2016. Similar trends were also observed in other Asian countries. Most of the studies, including those from USA and UK employed generic HRQoL tools, viz. EQ-5D, SF-36, SF-12 and SF-6D. The diabetes specific assessment tools like ADDQoL were used very sparsely. A QoL tool (Quality of Life Instrument for Indian Diabetes patients, QOLID) specific for Indian patients with diabetes has also been developed recently but needs further validation. The need for research into the humanistic burden of diabetes is being increasingly recognized worldwide, including in Asian countries such as India, and may be expected to improve patient care.

Health-Related Quality of Life of Adolescent and Young Adult Survivors of Central Nervous System Tumors: Identifying Domains From a Survivor Perspective.

This article uses qualitative methods to describe the domains of health-related quality of life (HRQoL) that adolescent and young adult (AYA) survivors of central nervous system (CNS) tumors identify as important. Survivors clearly attributed aspects of their current HRQoL to their disease or its treatment. We identified 7 key domains of AYA CNS tumor survivorship: physical health, social well-being, mental health, cognitive functioning, health behaviors, sexual and reproductive health, and support systems. Although most aspects of HRQoL that survivors discussed represented new challenges, there were several areas where survivors pointed out positive outcomes. There is a need for a HRQoL tool designed for this population of survivors, given their unique treatment and survivorship experience. Aspects of HRQoL related to cognition, sexual and reproductive health, health behaviors, and support systems are not typically included in generic HRQoL tools but should be assessed for this population. Developing HRQoL measurement instruments that capture the most significant aspects of HRQoL will improve the ability to track HRQoL in AYA CNS tumor survivors and in the long-term management of common sequelae from CNS tumors and their treatments.

35 * Literature review of health related quality of life measurement tools for patients with atrial fibrillation: could they be used as a patient reported outcome measure?

Introduction: The most common heart arrhythmia is atrial fibrillation (AF) where individuals can suffer symptoms that adversely affect health related quality of life (HRQoL). The main reason for rhythm control of AF is to reduce symptoms and improve patients HRQoL. Patient reported outcome measures (PROMs) were developed to measure patient's HRQoL to give an indication of improvement as a result of certain treatments. A variety of tools exist to measure HRQoL in patients with AF, these include generic measurement scales or disease specific tools. A literature review was carried out in 2013 to assess tools that measure HRQoL in AF and to consider if they had potential of being a PROM for clinical practice. Methods: Several online databases were used. Searches were restricted to those in English with full text and published from 2003-2013. Articles were excluded if it wasn't specified what tool was used, if a clinician reported outcome measure was used, if the tool was a generic HRQoL tool and where the study population wasn't AF. Results: 868 pieces of literature were identified to have used a HRQoL tool following the initial search: reduced to 26 after exclusion criteria was applied, with a total of 4 AF specific HRQoL tools which are listed below: Atrial Fibrillation Effect on Quality-of-Life (AFEQT) Development of a questionnaire to measure health-related quality of life in patients with atrial Fibrillation (AFQoL) Quality of Life of Atrial Fibrillation (AFQLQ) Quality of life in AF patients (QLAF) Each AF specific tool was examined in more detail, in particular their development, validation, application to clinical practice and limitations. 4 tools specific to AF were available to measure HRQoL. These tools have been developed in various ways, mostly based on literature reviews with all appearing to have a significant amount of clinical opinion alongside some patient input in initial stages. All mentioned tools have been validated alongside generic HRQoL tools and some with AF symptom scales. All these tools have shown to measure HRQoL but as most are made with principally clinician input in developmental stages, it is questionable if it can be classed as a PROM, thus having limited usefulness to the NHS in the collection of data. Conclusions: Due to the outcomes of this literature review it became evident how crucial the need for an AF specific PROM is. Development and validation of new HRQoL assessment tools with significant patient input in developmental stages would be beneficial to assist clinicians to decide patient treatments in clinical practice. It would further ensure that research in AF regarding HRQoL treatment is measured effectively and accurately providing an indication of the effectiveness of these treatments. An AF specific PROM recognised by the NHS could to be used in a similar way to other disease specific PROMs nationwide to compare outcomes of treatments.

L30 The Quality Of Life Of Patients With Huntington's Disease In France Measured With H-qol-i, Eq-5d And Sf-36

Background Assessing Health Related Quality of Life (HRQoL) with validated instruments is essential when evaluating the burden of Huntington’s disease (HD). Generic HRQoL tools, such as EuroQol-5 dimensions questionnaire and the Short Form (36) Health Survey (EQ-5D and SF-36), allow comparison between diseases, but may be insensitive. Disease-specific instruments, such as the Huntington Quality of Life instrument (H-QoL-I) specifically designed for patients suffering with HD, are thought to be more sensitive, but only allow comparisons within the same disease. Aim The aim of the study was to assess HD patients’ HRQoL in France, and to compare the results provided by EQ-5D, SF-36 and H-QoL-I. Methods The design was an observational, cross-sectional study to investigate the burden of disease (BoD) and HRQoL of HD patients. HD patients were recruited through the national French association “Huntington France”. The EQ-5D, SF-36 and H-QoL-I were voluntarily self-administered. Results 175 patients were recruited. The mean age was 56.5 (± 11) years; 49.4% were female. Results from the H-QoL-I showed that motor and psychological dimensions (scores: 37.12 and 37.02 respectively) were the most affected dimensions; whereas the social dimension was less affected (score 53.82). For the EQ-5D, self-care and usual activities were the most altered dimensions and pain was the least altered dimension. For the SF-36, role-emotional limitations and role-physical limitations were the most altered dimensions and bodily pain was the least altered dimension (scores: 27.08, 30.52, and 69.12 respectively). Conclusion French HD patients’ HRQoL was highly affected by their disease. Consistent results were found between the three instruments: motor and psychological dimensions were the most affected whereas the pain dimension was least affected. Better therapeutic options to improve HD motor function, and hence, HRQoL are needed.

RHINASTHMA-Adolescents: a new quality of life tool for patients with respiratory allergy.

Specific instruments for health-related quality of life (HRQoL) assessment in adolescents with rhinoconjunctivitis or asthma are available. None of them evaluates rhinitis and asthma together, although they often coexist. Our aim was to validate a HRQoL questionnaire for adolescents with rhinoconjunctivitis, asthma, or both. A pool of 38 items covering the main symptoms and problems related to respiratory allergy was generated based on literature review, clinical experience, and unstructured interviews to 54 adolescents. The items were randomly listed and presented to 88 consecutive outpatients (44 M; mean age 15.2±3.1). Patients had to indicate which item they had experienced and, for each selected item, its importance on a four-point scale (1=not at all; 4=very much). Twelve items were excluded from the list, because of low importance. In the validation phase, 102 patients (54 M; mean age 15.36±1.12) completed the KINDL, a generic HRQoL tool, and the new questionnaire (RHINASTHMA-Adolescents). Factor analysis revealed a five-dimensional structure, which explained up to 71.23% of the total variance. Association between RHINASTHMA-Adolescents and KINDL scores was all in the expected direction. Internal consistency for the extracted factors was satisfactory: Upper Airways (0.81), Lower Airways (0.89), Emotions (0.85), Social Relationship (0.79), Daily life management (0.74). Reliability was good for all factors with a Pearson coefficient ranged from 0.91 to 0.99. RHINASTHMA-Adolescents is the first tool for evaluating HRQoL in patients with rhinitis and/or asthma. It provides a simple assessment and met the standards of validity, internal consistency, and reliability.

Health-related quality of life in inflammatory bowel disease measured with the generic 15D instrument

In many surveys, inflammatory bowel disease (IBD) has been shown to have a negative impact on health-related quality of life (HRQoL), especially when the disease is active. The purpose of this study was to compare a disease-specific HRQoL tool (Inflammatory Bowel Disease Questionnaire, IBDQ) and a generic HRQoL tool (15D) in a large cohort of IBD patients, to assess the ability of the 15D to detect differences in HRQoL between disease states and to compare the HRQoL of IBD patients with that of the general population. The study population comprised 2,931 IBD patients over 18 picked from a national Social Insurance Institute register and from a patient organization register. The 15D data for the general population came from the National Health 2000 Health Examination Survey. For patients with IBD, the 15D tool was feasible and had good discriminatory power. The total 15D score was significantly higher among patients with less active disease estimated by frequency of IBD symptoms and was strongly correlated with total IBDQ score. The general population scored significantly higher than did the study subjects on most of the 15D dimensions. The 15D was a fast and easy-to-apply method for the examination of HRQoL in IBD patients. In addition to HRQoL studies it could be used in everyday practice as well. Patients with IBD have worse HRQoL than do gender- and age-standardized controls.

Home-based pulmonary rehabilitation program: Effect on exercise tolerance and quality of life in chronic obstructive pulmonary disease patients

BACKGROUND:A key component in the management of chronic obstructive pulmonary disease (COPD) patients is pulmonary rehabilitation (PR), the corner stone of which is exercise training.AIM:This study aims to evaluate the effect of a two-months, home-based PR program with outpatient supervision every two weeks, on exercise tolerance and health-related quality of life (HRQL) using Arabic-translated standardized generic and specific questionnaires in COPD patients recently recovered from acute exacerbation,DESIGN:Randomized clinical trial.SETTING AND SUBJECTS:A total of 39 COPD patients who recovered from acute exacerbation were randomly allocated either a two-month home-based PR program in addition to standard medical therapy or standard medical therapy alone in the period between July 2008 and March 2009.METHODS:Pulmonary function tests (PFTs), six-minute walk distance (6-MWD) test, Arabic-translated chronic respiratory disease questionnaire-self administered standardized format (CRQ-SAS) and quality of life scale Short Form (SF-36) were compared between 25 patients with moderate to severe COPD who underwent a two-month PR program (group 1) and 14 COPD patients who did not (group 2).RESULTS:Group 1 showed significant improvement in the 6-MWD, and HRQL scores at two months compared with the usual care patients in group 2 (P less than 0.05). Improvement in both CRQ-SAS and SF-36 scores were statistically significant and comparable in group 1.CONCLUSION:The supervised, post discharge, two-month home-based PR program is an effective non pharmacological intervention in the management of stable patients with COPD. The 6-MWD is a simple, inexpensive and safe test to assess physical and functional capabilities among COPD patients. HRQL can be measured in patients with COPD either by disease-specific tools that have been specifically designed for use in patients with respiratory system disorders or by generic HRQL tools that can be used across populations with a variety of medical conditions. The Arabic-translated CRQ-SAS is a new tool for assessment of Arabic-speaking patients with chronic respiratory diseases.

Understanding quality of life for children after liver transplantation: A work in progress

Understanding quality of life for children after liver transplantation: A work in progress

The Effect of Auditory Stress on Perception of Intraesophageal Acid in Patients With Gastroesophageal Reflux Disease

Most patients with gastroesophageal reflux disease (GERD) report that stress exacerbates their symptoms, yet mechanisms underlying this association remain unknown. We sought to determine the effect of an acute laboratory stressor on perceptual and emotional responses to intraesophageal acid perfusion in healthy controls and patients with GERD. Forty-six patients with heartburn and 10 healthy controls underwent upper endoscopy and, if negative, pH monitoring. Assessment of psychologic factors and health-related quality of life was done by a questionnaire. Perceptual and emotional responses to intraesophageal acid at baseline, during auditory stress, and during an auditory control condition were determined using a randomized crossover design. Plasma levels of norepinephrine, adrenocorticotropic hormone, and cortisol were assessed. Twenty-nine subjects were identified as nonerosive reflux disease and 17 as erosive esophagitis. Quality of life, psychologic profile, and personality assessment variables were similar among the 2 patient groups and the controls. There was a significant reduction in mean lag time to initial symptom perception and an increase in mean intensity rating and mean acid perfusion sensitivity score in the 2 patient groups during the stress period, which was not seen during the control condition. Healthy controls demonstrated lack of a significant change in all parameters of stimulus response functions to acid, regardless of condition. Acute auditory stress can exacerbate heartburn symptoms in GERD patients by enhancing perceptual response to intraesophageal acid exposure. This greater perceptual response is associated with greater emotional responses to the stressor.

PGI17: COMPARISON OF GENERIC VERSUS DISEASE SPECIFIC TOOLS FOR THE MEASUREMENT OF HEALTH-RELATED QUALITY OF LIFE IN CROHN'S DISEASE

Health-related quality of life (HRQoL) research suggests that, due to unique characteristics of a disease state, disease specific tools are better discriminators of health status than generic tools. OBJECTIVE: To compare generic (SF-12) versus disease specific (SIBDQ) quality of life tools in a cohort of patients receiving treatment for Crohn's Disease (CD). METHODS: Structural Equation Modeling techniques were used to evaluate the effectiveness of the SF-12 and the SIBDQ for evaluating health status patients with CD. A cohort of 151 patients with CD receiving drug therapy was administered both instruments via telephone survey. RESULTS: The variance explained by the SIBDQ in this population was 11.6% while the SF-12 explained 55.7%. Adapted models of both the SIBDQ and SF-12 resulted in explained variance of 54.8% and 84.1%, respectively. CONCLUSIONS: Given these results, the generic HRQoL tool was significantly better than the disease specific tool at measuring and accounting for health status in this population. Patients with moderate or severe CD have previously been shown to have differing clinical response to therapy based upon disease severity, whereby patients with more severe disease have better response. Due to these possible unique clinical outcomes of newer medications such as infliximab, the effectiveness of disease specific tools may be compromised since improving therapies may affect HRQoL in a different manner than therapies previously available. Other innovative therapies, such as biologic response modifiers for rheumatoid arthritis, may have similar findings related to HRQoL measurement. This potential problem with HRQoL measurement is likely to increase as biopharmaceutical and pharmacogenomic research increases the number and rate of new product approvals. These findings have important implications related to measurement of HRQoL in clinical trials and pharmacoeconomic evaluation of medications. This suggests a need for careful reevaluation of disease specific tools given the clinical effects of newer therapies.

Health-related quality of life outcomes measures

Andresen EM, Meyers AR. Health-related quality of life outcomes measures. Arch Phys Med Rehabil 2000;81 Suppl 2:S30-S45. Objective: To review critically the features of measures of generic health-related quality of life (HRQOL) for disability outcomes research. Data Sources: A search of electronic databases, summary reviews, books, and government documents was performed. Comment and experiences from participants of a conference on outcomes research were also incorporated. Study Selection: English language literature from scientists from a broad range of disciplines and research settings, including medicine, nursing, social science, and public health, and health services research and practice. Data Extraction: A critical review of measures that have been or might be used to measure disability outcomes. Data Synthesis: Commonly used generic measures of HRQOL can be applied to disability outcomes research with some caveats. Three common tools are the Medical Outcomes Study Short-Form Health Survey (SF-36), Sickness Impact Profile (SIP), and Quality of Well-Being (QWB) scale. The SF-36 and SIP have been used with some success in research with people with disability. The QWB scale has been used less frequently. Conclusion: Most studies using generic HRQOL tools are of groups with specific impairments rather than heterogeneous groups of people with disability. None of the tools appears to measure HRQOL without some potential biases (eg, inappropriate wording) for people with disability, but more specific testing of these problems is needed. Also needed are studies to determine whether these tools can measure meaningful longitudinal changes. © 2000 by the American Congress of Rehabilitation Medicine