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Health-related Quality (Health-relat + quality)
Selected AbstractsDeterminants of Health-related Quality of Life in Adults with Psychogenic Nonepileptic Seizures: Are There Implications for Clinical Practice?EPILEPSIA, Issue 2 2003Gretchen L. Birbeck MD No abstract is available for this article. [source] Validity of Three Measures of Health-related Quality of Life in Children with Intractable EpilepsyEPILEPSIA, Issue 10 2002Elisabeth M. S. Sherman Summary: ,Purpose: Validity studies on health-related quality of life (HRQOL) scales for pediatric epilepsy are few, and cross-validation with other samples has not been reported. This study was designed to assess the validity of three parent-rated measures of HRQOL in pediatric epilepsy: (a) the Impact of Childhood Illness Scale (ICI), (b) the Impact of Child Neurologic Handicap Scale (ICNH), and (c) the Hague Restrictions in Epilepsy Scale (HARCES). Methods: Retrospective data were examined for 44 children with intractable epilepsy. Validity was assessed by evaluating differences across epilepsy severity groups as well as correlations between HRQOL scales and neurologic variables (seizure severity, epilepsy duration, current/prior antiepileptic medications) and psychosocial measures (emotional functioning, IQ, social skills, adaptive behavior). Scale overlap with a global QOL rating also was assessed. Results: The HRQOL measures were moderately to highly intercorrelated. The scales differed in terms of their associations with criterion measures. The HARCES was related to the highest number of neurologic variables and the ICNH to the fewest. All three scales were related to psychosocial functioning and to global quality of life. Conclusions: The results of this study suggest that the three measures are likely adequate measures of HRQOL for use in intractable childhood epilepsy. The measures were highly intercorrelated, and they were all broadly related to criterion measures reflecting specific domains of HRQOL as well as global QOL. Some differences between scales emerged, however, that suggest care in choosing HRQOL instruments for children with epilepsy. [source] Validation of the Chinese version of the MacNew Heart Disease Health-related Quality of Life questionnaireJOURNAL OF EVALUATION IN CLINICAL PRACTICE, Issue 2 2008Doris S. F. Yu RN PhD Abstract Rationale, Patient-reported outcomes such as health-related quality of life (HRQL) describe or characterize what patients have experienced as a result of their health care. However, treatment outcome comparisons among different pure or mixed populations of patients with myocardial infarction, angina or heart failure cannot be made using existing coronary heart disease (CHD)-specific HRQL instruments. Aims and objectives, The aim of this study was to evaluate the psychometric properties of the Chinese version of the MacNew in a cohort of Hong Kong patients diagnosed with CHD. Methods, Chinese translations of a CHD-specific HRQL instrument, the MacNew Heart Disease HRQL questionnaire (MacNew), the Short-form 36 Health Survey and the Hospital Anxiety and Depression Scale were administered to 365 Chinese-speaking patients with CHD at baseline and again 3 months later (n = 363). The Medical Outcomes Trust Scientific Advisory Committee criteria were used to examine the psychometric properties of the Chinese MacNew Heart Disease HRQL questionnaire. Results, The results warrant recommending the use of the MacNew as an outcome measure to enhance treatment evaluation in Chinese patients with CHD and a diagnosis of myocardial infarction, angina or heart failure, substantiating previous psychometric data on the MacNew in a number of different studies in patients speaking seven different languages. Conclusion, The MacNew questionnaire may have value as a core CHD questionnaire for treatment outcome comparisons among pure or mixed populations of patients with myocardial infarction, angina or heart failure. [source] Measuring Parental Perceptions of Child Oral Health-related Quality of LifeJOURNAL OF PUBLIC HEALTH DENTISTRY, Issue 2 2003Aleksandra Jokovic MSc Abstract Objectives: The aim of this study was to develop and evaluate the P-CPQ, a measure of parental/caregiver perceptions of the oral health-related quality of life of children. This forms one component of the Child Oral Health Quality of Life Questionnaire (COHQOL). Methods: An item pool was developed through a review of existing child health questionnaires and interviews with parents/caregivers of children with pedodontic, orthodontic, and orofacial conditions. The resulting 47 items were used in a study in which 208 parents/caregivers provided data on their frequency and importance. The 31 items rated the most frequent and important were selected for the final questionnaire (P-CPQ). The P-CPQ validity and reliability were assessed by a new sample of 231 parents, 79 of whom completed two copies for the assessment of test-retest reliability. Results: The P-CPQ discriminated among the three clinical groups included in the expected direction. Within-group analyses using clinical data provided some evidence that scores were associated with the severity of the condition. The P-CPQ also showed good construct validity. It had excellent internal consistency reliability with a Cronbach's alpha of 0.94 and demonstrated perfect test-retest reliability (ICC=0.85). Conclusion: The study provides data to indicate that the P-CPQ is valid and reliable. [source] Is Depressive Symptomatology Associated with Worse Oral Functioning and Well-being Among Older Adults?JOURNAL OF PUBLIC HEALTH DENTISTRY, Issue 1 2002Nancy R. Kressin PhD; Abstract Objectives: Although depression negatively affects individuals' physical functioning and well-being, its association with oral functioning and well-being has not been examined previously. The objective of this study was to examine the association between depressive symptomatology and oral quality of life. Methods: We utilized data from two samples of older adults: community-dwelling participants who used community primary care physicians in Los Angeles (n=7,653) and individuals who sought ambulatory care through four Department of Veterans Affairs facilities in the Boston metropolitan area (n=212). Depressive symptomatology was measured with the CES-D scale; Oral Quality of Life was measured with the Geriatric Oral Health Assessment Instrument and the Oral Health-related Quality of Life measure. We conducted hierarchical regression analyses to examine the effects of depression on oral quality of life, controlling for self-reported oral health, age, education, income, and marital status. Results: Individuals with more depressive symptoms reported worse oral quality of life, controlling for socio demographic factors and self-reported oral health. This finding persisted across multiple samples and both sexes, and using two measures of oral quality of life. Conclusion: These findings further emphasize the importance of treating depression among older adults, and suggest that both dentists and physicians have a role in recognizing and referring patients for such treatment. [source] Changes in parent-assessed oral health-related quality of life among young children following dental treatment under general anaestheticCOMMUNITY DENTISTRY AND ORAL EPIDEMIOLOGY, Issue 2 2008P. E. Malden Abstract,,, Objective:, To estimate the nature and magnitude of changes in oral health-related quality of life (OHRQoL) among children having dental treatment under general anaesthetic (GA) and to examine the evaluative properties of the Child Oral Health-related Quality of Life Questionnaire (COHQOL©). Methods:, Data from a consecutive clinical sample of the parents/caregivers of children receiving dental treatment under GA at Wellington and Kenepuru Hospitals were collected from parents using the Parental-Caregivers Perception Questionnaire (P-CPQ) and the Family Impact Scale (FIS), which both form part of the COHQOL© Questionnaire. The first questionnaire was completed before treatment or while the participant's child was undergoing treatment. The follow-up questionnaire was completed 1,4 weeks afterward. Treatment-associated changes in OHRQoL were determined by comparing baseline and follow-up data for the mean scores and the prevalence of impacts. The discriminative properties of the instrument were confirmed and then its evaluative properties were assessed (by examining its test,retest reliability, responsiveness and longitudinal construct validity). The minimally important difference was determined for the overall scale and subscales. Results:, Complete baseline and follow-up data were obtained for 202 and 130 participants, respectively (64.4% follow-up rate). The evaluative properties of the P-CPQ and FIS were acceptable. There were substantial and highly statistically significant reductions in mean P-CPQ and FIS scores after treatment, with effect sizes ranging from moderate to large, depending on the subscale being examined. The minimally important difference was shown by almost two-thirds of the children treated. Conclusion:, The provision of dental treatment under GA for young children with severe dental caries experience is associated with substantial and highly significant improvements in both their OHRQoL and in the impact on their families. The P-CPQ and the FIS show promise as evaluative measures for use in dental health services research. [source] Relationship between intensity of physical activity and health-related quality of life in Portuguese institutionalized elderlyGERIATRICS & GERONTOLOGY INTERNATIONAL, Issue 4 2008Alexandrina Lobo Aims: Health-related quality of life (HRQOL) is considered to be the key goal for health promotion in older people. This study explores the relationship between HRQOL and objectively measured intensity of physical activity (PA) in institutionalized older adults. The analysis of the PA patterns of the subjects in relation to recommended levels of PA was also performed. Methods: One hundred and eighty-five residents of long-term care homes aged 65 years or more, volunteered for this study. The Medical Outcome Study Short Form 36-Item health survey (MOS SF-36) questionnaires and the uni-axial MTI Actigraph were used to assess HRQOL and PA, respectively. Participants were classified as less active, reasonably active and more active by tertile of moderated physical activity (MPA). Results: (i) The men represented a greater number of counts/h and min of MPA in all the tertile groups; (ii) men from the less active group had a significantly higher body mass index; (iii) women came third and exhibited less total activity even though they used this time in more intense activities; (iv) there was a higher significant correlation between MPA, physical function and negative association with body pain in relation to the time of institutionalization in both sexes but was more strongly visible in men; and (v) only men presented a significant positive association with physical health, mental health and vitality. Conclusion: Any intensity of PA seems to be better than no activity for HRQOL, but MPA confers greater benefits for the perception of physical function and body pain in the case of institutionalized elderly persons. [source] Quality of life and depression of people living with type 2 diabetes mellitus and those at low and high risk for type 2 diabetes: findings from the Study to Help Improve Early evaluation and management of risk factors Leading to Diabetes (SHIELD)INTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 4 2008S. Grandy Summary Objectives:, This study compared health-related quality of life (HRQoL) and depression among individuals with type 2 diabetes mellitus (T2D) and those at low or high risk for T2D. Methods:, Respondents in a population-based US 2004 survey reported whether they had T2D (n = 3530) or risk factors for T2D [abdominal obesity, body mass index (BMI) , 28 kg/m2, dyslipidaemia, hypertension and history of cardiovascular disease]. Respondents without T2D were stratified into low risk (0,2 risk factors, n = 5335) and high risk (3,5 risk factors, n = 5051). SF-12 version 2 (SF-12) and Patient Health Questionnaire (PHQ)-9 were used to measure HRQoL and depression. Mean scores were compared across the three groups using analysis of variance. Linear regression identified factors associated with SF-12 Physical and Mental Component Summary scores (PCS and MCS), adjusting for age, gender, race, income, geographic region, household size, BMI and group. Results:, Respondents were mostly women (60%) with mean age of 54 years. Mean PCS scores for T2D and high risk (39.5 and 41.7, respectively) were significantly lower than for low risk (50.6, p < 0.001). After adjustment, high-risk and T2D groups were associated with lower PCS and MCS scores compared with low risk group (p < 0.05). Mean PHQ-9 scores and per cent with moderate-to-severe depression were significantly higher for T2D and high risk than for low risk (p < 0.01). Conclusions:, Health-related quality of life and depression scores in T2D were similar to those at high risk, and indicated significant decrements in physical health and greater depression compared with low-risk respondents. [source] Impact of Recent Fracture on Health-Related Quality of Life in Postmenopausal Women,,JOURNAL OF BONE AND MINERAL RESEARCH, Issue 6 2006Susan K Brenneman PT Abstract The effect of fractures other than hip and spine on HRQoL in younger and older women has not been extensively studied. In a cohort of 86,128 postmenopausal women, we found the impact of recent osteoporosis-related fractures on HRQoL to be similar between women <65 compared with those ,65 years of age. The impact of spine, hip, or rib fractures was greater than that of wrist fractures in both age groups. Introduction: Health-related quality of life (HRQoL) after vertebral and hip fractures has been well studied. Less is known about HRQoL after fractures at other sites. We studied the effect of recent clinical fractures on HRQoL, using Short Form-12 (SF-12). Materials and Methods: This study included 86,128 postmenopausal participants in the National Osteoporosis Risk Assessment (NORA) who responded to two follow-up surveys during a 2-year interval. At each survey, they completed the SF-12 HRQoL questionnaire and reported new fractures of the hip, spine, wrist, and rib. The effect of recent fracture on HRQoL was assessed by comparing Physical Component Score (PCS) and Mental Component Score (MCS) means for women with and without new fractures at the second survey. Analyses were by fracture type and by age group (50,64 and 65,99) and were adjusted for PCS and MCS at the first survey. Results: New fractures (320 hip, 445 vertebral, 657 rib, 835 wrist) occurring during the interval between the first and second follow-up surveys were reported by 2257 women. The PCS was poorer in both older and younger women who had fractured the hip, spine, or rib (p , 0.001). Wrist fractures had an impact on PCS in women ,65 years of age (p < 0.001), but not older women (p > 0.10). These differences in PCS by fracture status were similar to those reported for other chronic diseases such as asthma, chronic obstructive pulmonary disease (COPD), and osteoarthritis. MCS was less consistently changed by fracture status, but younger and older women with vertebral fracture (p < 0.004), older women with hip fracture (p < 0.004), and younger women with rib fracture (p < 0.004) had poorer MCS compared with those who did not fracture within their age cohort. Conclusions: Recent osteoporosis-related fractures have significant impact on HRQoL as measured by SF-12. The impact of recent fracture on HRQoL was similar for older and younger postmenopausal women. Fracture prevention and postfracture interventions that target the subsequent symptoms are needed for postmenopausal women of any age. [source] Health-related quality of life and symptom classification in patients with irritable bowel syndromeJOURNAL OF NURSING AND HEALTHCARE OF CHRONIC ILLNE SS: AN INTERNATIONAL INTERDISCIPLINARY JOURNAL, Issue 1 2010Graeme D Smith smith gd, steinke dt, penny ki, kinnear m & penman id (2010) Journal of Nursing and Healthcare of Chronic Illness2, 4,12 Health- related quality of life and symptom classification in patients with irritable bowel syndrome Background., Previous research has established that health-related quality of life can be adversely affected by irritable bowel syndrome IBS. Irritable bowel syndrome has been classified to subgroups by predominant bowel symptom: constipation, diarrhoea or alternating between the two. Little is presently known about the specific impact of irritable bowel syndrome on health-related quality of life within disease sub-groups across time. Aims., To examine the health-related quality of life in a cohort of individuals with irritable bowel syndrome to explore the association between quality of life and disease subtype classification. Setting., The general population of the UK. Design., Longitudinal cohort survey was conducted. Methods., Individuals with symptoms of irritable bowel syndrome were recruited via a UK-wide newspaper advertisement. The health-related quality of life was measured using a battery of validated questionnaires. Results., Data on 494 participants with a Rome II confirmed diagnosis of irritable bowel syndrome were examined. Measurement of generic health-related quality of life revealed lower median scores (poorer quality of life) in anxiety/depression and pain/discomfort domains of health. Conclusion., Health-related quality of life is impaired in community based individuals with IBS. Patients appear to fluctuate between sub-groups when irritable bowel syndrome is classified across time. This study suggests that the impact of irritable bowel syndrome may be greatly underestimated. Relevance for clinical practice., The use of sub-group classification and understanding of predictive factors may allow for a more flexible and efficient approach to healthcare assessment and patient care for people with irritable bowel syndrome. [source] Improvement in Quality of Life After Treatment for Alcohol Dependence With Acamprosate and Psychosocial SupportALCOHOLISM, Issue 1 2004Marsha Y. Morgan Abstract: Background: The impact of disease on health-related quality of life is now well recognized, as is the importance of this variable as a measure of treatment efficacy. Methods: Patients from five European countries were enrolled in an open, multicenter, prospective study designed to observe outcome in dependent drinkers treated for 6 months with acamprosate and psychosocial support. Version 1 of the 36-item Short Form Health Profile (SF-36v1) questionnaire was administered at inclusion and at 3 and 6 months. Responses were described as handicaps compared with an appropriately matched, healthy reference population. One-way fixed ANOVA and simultaneous stepwise linear regression analysis were used to identify potential predictors of quality of life at baseline and after treatment. Results: Baseline SF-36v1 data were obtained from 1216 patients (mean age, 43 ± 9 years; 77% male). Mean values for all SF-36v1 dimensions were significantly lower in the patient population than in the normative reference population; the most important deficits were observed in physical and emotional role limitations and in social functioning. The most important predictors of baseline quality of life were severity of alcohol dependence, employment status, psychiatric history, quantity and frequency of alcohol consumption, attendance at Alcoholics Anonymous, global alcohol health status, age, gender, and education. SF-36v1 data were obtained from 686 patients at 3 months and from 497 at 6 months. Significant improvements were observed in all SF-36v1 dimensional and summary scores after 3 months of treatment (p < 0.001); further marginal improvements were observed between 3 and 6 months. The most important predictors of quality of life following treatment were the SF-36v1 profile at baseline, followed by abstinence duration; patients who completed the trial and remained abstinent throughout showed the greatest improvement. Conclusions: Health-related quality of life is severly impaired in dependent drinkers. Treatment with acamprosate and psychosocial support, by promoting abstinence, improves the quality of life profile to levels comparable to those observed in healthy individuals. [source] Health-related quality of life of food allergic patients measured with generic and disease-specific questionnairesALLERGY, Issue 8 2010B. M. J. Flokstra-de Blok To cite this article: Flokstra-de Blok BMJ, van der Velde JL, Vlieg-Boerstra BJ, Oude Elberink JNG, DunnGalvin A, Hourihane JO'B, Duiverman EJ, Dubois AEJ. Health-related quality of life of food allergic patients measured with generic and disease-specific questionnaires. Allergy 2010; 65: 1031,1038. Abstract Background:, Health-related quality of life (HRQL) has never been measured with both generic and disease-specific questionnaires in the same group of food allergic patients. The aim of this study was to compare HRQL of food allergic patients as measured with generic and disease-specific questionnaires. Methods:, Generic questionnaires (CHQ-CF87 and RAND-36) and disease-specific HRQL questionnaires (FAQLQ-CF, -TF and -AF) were completed by 79 children, 74 adolescents and 72 adults with food allergy. Floor and ceiling effects, percentage of agreement and multivariate stepwise regression analysis were used to compare the generic and disease-specific measurements. Results:, The Food Allergy Quality of Life Questionnaires (FAQLQs) showed minimal floor or ceiling effects. The CHQ-CF87 and RAND-36 showed minimal floor effects, but remarkable ceiling effects (>73%) were found for the scales role functioning-emotional (RE), role functioning-behaviour (RB), role functioning-physical (RP) in children and adolescents and the scale RE (>79%) in adults. Additionally, we found low percentages of agreement between the generic and disease-specific questionnaires to identify the same food allergic patients with the best or worst HRQL. Only patients with the best disease-specific HRQL also tended to have the best generic HRQL. Finally, the explained variance in HRQL by patient characteristics was higher in the disease-specific questionnaires (30.7,62.8%) than in the generic scales (6.7,31.7%). Conclusion:, Disease-specific HRQL questionnaires may be more suitable to measure clinically important impairments in HRQL or HRQL differences over time in food allergic patients. However, generic HRQL questionnaires are indispensable for the comparison between different diseases and are thus complementary. [source] Development and validation of the Food Allergy Quality of Life Questionnaire , Adult FormALLERGY, Issue 8 2009B. M. J. Flokstra-de Blok Background:, Health-related quality of life (HRQL) may be affected by food allergy. Presently, no disease-specific HRQL questionnaire exists for food allergic adults. Therefore, we developed and validated the Food Allergy Quality of Life Questionnaire , Adult Form (FAQLQ-AF) in the Dutch language. Methods:, Twenty-two food allergic patients (,18 years) were interviewed and generated 180 HRQL items. The most important items were identified by 54 food allergic patients using the clinical impact method resulting in the FAQLQ-AF containing 29 items (score range 1 ,not troubled' to 7 ,extremely troubled'). The FAQLQ-AF, the Food Allergy Independent Measure (FAIM) and a generic HRQL questionnaire (RAND-36) were sent to 100 other food allergic adults for cross-sectional validation of the FAQLQ-AF. Results:, Cross-sectional validity was assessed by the correlation between FAQLQ-AF and FAIM (, = 0.76, P < 0.001). The FAQLQ-AF had excellent internal consistency (Cronbach's , = 0.97). The FAQLQ-AF discriminated between patients who differ in severity of symptoms (anaphylaxis vs no anaphylaxis, total FAQLQ-AF score 4.9 vs 4.1; P = 0.041) and number of food allergies (>3 food allergies vs,3 food allergies, total FAQLQ-AF score 5.2 vs 4.2; P = 0.008). The total FAQLQ-AF score was correlated with one RAND-36 scale (convergent/discriminant validity). Conclusions:, The FAQLQ-AF is the first disease-specific HRQL questionnaire for food allergic adults and reflects the most important issues that food allergic patients have to face. The questionnaire is valid, reliable and discriminates between patients with different disease characteristics. The FAQLQ-AF is short and easy to use and may therefore be a useful tool in clinical research. [source] Impact of adalimumab treatment on health-related quality of life and other patient-reported outcomes: results from a 16-week randomized controlled trial in patients with moderate to severe plaque psoriasisBRITISH JOURNAL OF DERMATOLOGY, Issue 3 2008D. Revicki Summary Background, Health-related quality of life (HRQOL) and other patient-reported outcomes (PROs) are important in evaluating the impact of psoriasis and its treatment. Objectives, To assess the impact of adalimumab treatment on HRQOL and other PROs in patients with moderate to severe psoriasis. Methods, A 16-week, double-blind, double-dummy, randomized controlled trial evaluated the efficacy and safety of adalimumab in 271 adults with moderate to severe chronic plaque psoriasis. Patients were randomized in a 2 : 2 : 1 ratio to adalimumab, methotrexate (MTX) or placebo. PROs were evaluated throughout the study and included the Dermatology Life Quality Index (DLQI), Patient's Global Assessment of disease severity, plaque psoriasis and psoriatic arthritis pain visual analogue scale (VAS), Psoriasis-Related Pruritus Assessment and EuroQOL 5D (EQ-5D). Results, Statistically significant differences were observed between the adalimumab- and placebo-treated and the MTX-treated groups on mean DLQI total scores during the 16-week double-blind study (both P < 0·001). Significant differences, favouring adalimumab compared with placebo, were also observed on the Patient's Global Assessment of disease severity (P < 0·001), VAS for pain (P < 0·001), Psoriasis-Related Pruritus Assessment (P < 0·001), EQ-5D VAS (P < 0·001) and EQ-5D index score (P < 0·01). Compared with MTX, adalimumab resulted in statistically significantly greater improvements in the Patient's Global Assessment of disease severity (P < 0·001), the VAS for pain (P < 0·01) and the Psoriasis-Related Pruritus Assessment (P < 0·001). Conclusions, Adalimumab was efficacious in improving dermatology-specific HRQOL, disease control and symptom outcomes in patients with moderate to severe psoriasis. [source] Parent-proxy report of their children's health-related quality of life: an analysis of 13 878 parents' reliability and validity across age subgroups using the PedsQL 4.0 Generic Core ScalesCHILD: CARE, HEALTH AND DEVELOPMENT, Issue 5 2007Richard Reading Parent-proxy report of their children's health-related quality of life: an analysis of 13 878 parents' reliability and validity across age subgroups using the PedsQL 4.0 Generic Core Scales . VarniJ. W., LimbersC. A. & BurwinkleT. M. ( 2007 ) Health and Quality of Life Outcomes , 5 , 2 . DOI:10.1186/1477-7525-5-2. Background, Health-related quality of life (HRQOL) measurement has emerged as an important health outcome in clinical trials, clinical practice improvement strategies, and healthcare services research and evaluation. While paediatric patient self-report should be considered the standard for measuring perceived HRQOL, there are circumstances when children are too young, too cognitively impaired, too ill or fatigued to complete an HRQOL instrument, and reliable and valid parent-proxy report instruments are needed in such cases. Further, it is typically parents' perceptions of their children's HRQOL that influences healthcare utilization. Data from the PedsQL DatabaseSM were utilized to test the reliability and validity of parent-proxy report at the individual age subgroup level for ages 2,16 years as recommended by recent Food and Drug Administration (FDA) guidelines. Methods, The sample analysed represents parent-proxy report age data on 13 878 children ages 2,16 years from the PedsQL 4.0 Generic Core Scales DatabaseSM. Parents were recruited from general paediatric clinics, sub-specialty clinics and hospitals in which their children were being seen for well-child checks, mild acute illness or chronic illness care (n = 3,718, 26.8%), and from a State Children's Health Insurance Program in California (n = 10 160, 73.2%). Results, The percentage of missing item responses for the parent-proxy report sample as a whole was 2.1%, supporting feasibility. The majority of the parent-proxy report scales across the age subgroups exceeded the minimum internal consistency reliability standard of 0.70 required for group comparisons, while the total scale scores across the age subgroups approached or exceeded the reliability criterion of 0.90 recommended for analysing individual patient scale scores. Construct validity was demonstrated utilizing the known groups approach. For each PedsQL scale and summary score, across age subgroups, healthy children demonstrated a statistically significant difference in HRQOL (better HRQOL) than children with a known chronic health condition, with most effect sizes in the medium-to-large effect size range. Conclusion, The results demonstrate the feasibility, reliability and validity of parent-proxy report at the individual age subgroup for ages 2,16 years. These analyses are consistent with recent FDA guidelines which require instrument development and validation testing for children and adolescents within fairly narrow age groupings and which determine the lower age limit at which reliable and valid responses across age categories are achievable. Even as paediatric patient self-report is advocated, there remains a fundamental role for parent-proxy report in paediatric clinical trials and health services research. [source] | ||||||||||