A standard set of person-centred outcomes for diabetes mellitus: results of an international and unified approach.

AIMS: To select a core list of standard outcomes for diabetes to be routinely applied internationally, including patient-reported outcomes. METHODS: We conducted a structured systematic review of outcome measures, focusing on adults with either type 1 or type 2 diabetes. This process was followed by a consensus-driven modified Delphi panel, including a multidisciplinary group of academics, health professionals and people with diabetes. External feedback to validate the set of outcome measures was sought from people with diabetes and health professionals. RESULTS: The panel identified an essential set of clinical outcomes related to diabetes control, acute events, chronic complications, health service utilisation, and survival that can be measured using routine administrative data and/or clinical records. Three instruments were recommended for annual measurement of patient-reported outcome measures: the WHO Well-Being Index for psychological well-being; the depression module of the Patient Health Questionnaire for depression; and the Problem Areas in Diabetes scale for diabetes distress. A range of factors related to demographic, diagnostic profile, lifestyle, social support and treatment of diabetes were also identified for case-mix adjustment. CONCLUSIONS: We recommend the standard set identified in this study for use in routine practice to monitor, benchmark and improve diabetes care. The inclusion of patient-reported outcomes enables people living with diabetes to report directly on their condition in a structured way.

[Trisomy 18: how lethal is 'lethal'?] / Trisomie 18: hoe lethaal is 'lethaal'?

Should active treatment be available for children with trisomy 18? In the Netherlands, trisomy 18 is described as a lethal condition leading to death during or immediately after birth. The Dutch course of action for trisomy 18 is termination of pregnancy, almost without exception, or passive treatment without medical interventions. But that approach might be outdated. We present a case that inspired physicians and parents to rethink the perception of trisomy 18.

Utility of the Morisky Medication Adherence Scale in gout: a prospective study.

BACKGROUND: The outcomes of any chronic illness often depend on patients' adherence with their treatment. A tool is lacking to assess adherence in gout that is standardized, allows real-time feedback, and is easy to understand. OBJECTIVE: We set out to evaluate the utility of the 8-item Morisky Medication Adherence Scale (MMAS-8) in monitoring medication adherence in a multiethnic Asian gout cohort on urate-lowering therapy (ULT). METHODS: This cohort study recruited patients with gout where baseline and 6-monthly clinical data, self-report of adherence, and health status by Gout Impact Scale (GIS) and EuroQoL-5 dimension 3 levels were collected. Those who received at least 9 months of ULT were analyzed. Convergent and construct validities of MMAS-8 were evaluated against medication possession ratio (MPR) and known groups, clinical outcomes, and patient-reported outcomes. Internal consistency and test-retest reliability were assessed using Cronbach's alpha and intraclass correlation coefficient (ICC), respectively. RESULTS: Of 91 patients, 92.3% were male, 72.5% Chinese with mean age 53.5 years. MMAS-8 (mean 6.17) and MPR (mean 96.3%) were poorly correlated (r=0.069, P=0.521). MMAS-8 did not differ between those who did or did not achieve target serum urate (SU) <360 µmol/L (P=0.852); or among those whose SU improved, stagnated, or worsened during follow-up (P=0.777). Adherence was associated with age (ß=0.256, P=0.015) and education level (P=0.011) but not comorbidities, polypharmacy, or flare frequency. Concerns for medication side effects and anxiety or depression were associated with lower MMAS-8 (P<0.005). Internal consistency was acceptable (α=0.725) and test-retest reliability was satisfactory (ICC =0.70, 95% confidence interval [CI] 0.36-0.88). CONCLUSION: MMAS-8 had limited construct validity in assessing medication adherence to ULT in our gout patients. Nevertheless, it identified patients bothered or worried about ULT side effects, and those with underlying anxiety or depression, for whom targeted education and coping support may be useful.

Humanistic and economic outcomes of pharmacist-provided medication review in the community-dwelling elderly: A systematic review and meta-analysis.

WHAT IS KNOWN AND OBJECTIVE: Recent reviews have shown that pharmacist-provided medication review in the elderly can improve clinical outcomes and reduce medication discrepancies compared with usual care. However, none determined whether these translate to improved humanistic and economic outcomes. This review sought to evaluate the effects of medication review on health-related quality of life (HRQoL) and healthcare costs in the elderly. METHODS: A systematic search of MEDLINE, EMBASE, CINAHL, Web of Science and the Cochrane library for studies published in English from inception to 31 August 2015 was conducted. The review included studies lasting at least 3 months that randomly assigned community-dwelling participants aged at least 65 years to receive either pharmacist-provided medication review or usual care. Studies set in nursing homes were excluded. RESULTS AND DISCUSSION: The review identified 25 studies that included 15 341 participants and lasted between 3 and 36 months. Twenty and 13 studies reported HRQoL and economic outcomes, respectively. Overall, there was no significant difference in HRQoL and healthcare costs between pharmacist-provided medication review and usual care. Meta-analysis of studies that reported the 36-item Short-Form Health Survey found significant differences in favour of usual care in the body pain (mean difference: 2·94, 95% CI: 0·54-5·34, P = 0·02) and general health perception (mean difference: 1·83, 95% CI: 0·16-3·50, P = 0·03) domains, whereas there were no significant differences in other domains. Meta-analysis of the EuroQol-5D utility (mean difference: -0·01, 95% CI: -0·02-0·01, P = 0·57) and visual analogue scale (mean difference: 0·01, 95% CI: -3·24-3·26, P = 1·00) found no significant differences. Costs of hospitalization, medication and other healthcare resources consumed were similar between groups. WHAT IS NEW AND CONCLUSION: Humanistic and economic outcomes of pharmacist-provided medication review were largely similar to those of usual care. Further research using more robust methodology is needed to determine whether improved medication management can improve HRQoL and reduce healthcare costs. Careful thought should be given to capturing relevant outcomes that reflect the potential benefits of this intervention.

A scoring model for predicting survival following primary tumour resection in stage IV colorectal cancer patients with unresectable metastasis.

BACKGROUND: Stage IV colorectal cancer patients with unresectable metastasis who undergo elective primary tumour resection experience heterogeneous post-operative survival. We aimed to develop a scoring model for predicting post-operative survival using pre-operative variables to identify patients who are least likely to experience extended survival following the procedure. METHODS: Survival data were collected from stage IV colorectal cancer patients who had undergone elective primary tumour resection between January 1999 and December 2007. Coefficients of significant covariates from the multivariate Cox regression model were used to compute individual survival scores to classify patients into three prognostic groups. A survival function was derived for each group via Kaplan-Meier estimation. Internal validation was performed. RESULTS: Advanced age (hazard ratio, HR 1.43 (1.16-1.78)); poorly differentiated tumour (HR 2.72 (1.49-5.04)); metastasis to liver (HR 1.76 (1.33-2.33)), lung (HR 1.37 (1.10-1.71)) and bone (HR 2.08 ((1.16-3.71)); carcinomatosis (HR 1.68 (1.30-2.16)); hypoalbuminaemia (HR 1.30 (1.04-1.61) and elevated carcinoembryonic antigen levels (HR 1.89 (1.49-2.39)) significantly shorten post-operative survival. The scoring model separated patients into three prognostic groups with distinct median survival lengths of 4.8, 12.4 and 18.6 months (p < 0.0001). Internal validation revealed a concordance probability estimate of 0.65 and a time-dependent area under receiver operating curve of 0.75 at 6 months. Temporal split-sample validation implied good local generalizability to future patient populations (p < 0.0001). CONCLUSION: Predicting survival following elective primary tumour resection using pre-operative variables has been demonstrated with the scoring model developed. Model-based survival prognostication can support clinical decisions on elective primary tumour resection eligibility.

Understanding domains of health-related quality of life concerns of Singapore Chinese patients with advanced cancer: a qualitative analysis.

PURPOSE: Quality of life concerns in patients with advanced diseases might be different from other patients and are shaped by sociocultural context. The objective of this qualitative study was to identify domains and themes of health-related quality of life (HRQoL) that Chinese patients with advanced cancer in Singapore considered relevant and important. METHODS: English- and Chinese-speaking patients with advanced solid cancer were recruited from a tertiary cancer center and a community-based hospice for in-depth interview or focused group discussion. Thematic analysis was used to identify subthemes, themes, and domains from the transcripts. RESULTS: Forty-six ethnic Chinese (aged 26-86, 48% male) participated in the study. Six domains of HRQoL concerns were identified: pain and suffering, physical health, social health, mental health, financial well-being, and spiritual health. Pain and suffering are not limited to the physical domain, reflecting the multidimensional nature of this concept. Pain and suffering must also be understood within the cultural context. Healthcare relations (i.e., social health), existential well-being and religious well-being (i.e., spiritual health), and suffering (i.e., pain and suffering) are not fully captured in the existing HRQoL instruments. In addition, financial issues and the practice of secrecy in interpersonal relationships emerged as unique features possibly arising from our sociocultural context and healthcare financing landscape. CONCLUSION: Socioculturally specific issues not measured by the existing HRQoL instruments for use in patients with advanced cancers or terminal diseases were found in our study. These are non-physical pain and suffering, meaning of illness, meaning of death, financial issues, and practice of secrecy in interpersonal relationships.

Effect of the CYP3A5 and ABCB1 genotype on exposure, clinical response and manifestation of toxicities from sunitinib in Asian patients.

The objective of this study was to determine the effect of the CYP3A5 and ATP binding cassette subfamily B member 1 (ABCB1) single-nucleotide polymorphisms on the disposition of sunitinib and SU12662, on clinical response, and on the manifestation of toxicities in Asian metastatic renal cell carcinoma patients. At week 4 of each treatment cycle, toxicities and plasma steady-state levels were assessed. Clinical response was assessed after two cycles. Genotyping was performed by using the PCR restriction fragment length polymorphism method. The CC genotype for ABCB1 was associated with a higher sunitinib exposure (76.81 vs 56.55 ng ml(-1), P=0.03), higher risk of all-grade rash (RR 3.00, 95% CI 1.17-7.67) and mucositis (RR 1.60, 95% CI 1.10-2.34) and disease progression than compared with the CT/TT genotype. There was a lack of association observed between the CYP3A5 polymorphism and exposure, response and toxicities. The polymorphism of ABCB1 (C3435T) has an important role in the manifestation of toxicities and drug exposure, but not polymorphism of CYP3A5.

Quantifying the natural history of breast cancer.

BACKGROUND: Natural history models of breast cancer progression provide an opportunity to evaluate and identify optimal screening scenarios. This paper describes a detailed Markov model characterising breast cancer tumour progression. METHODS: Breast cancer is modelled by a 13-state continuous-time Markov model. The model differentiates between indolent and aggressive ductal carcinomas in situ tumours, and aggressive tumours of different sizes. We compared such aggressive cancers, that is, which are non-indolent, to those which are non-growing and regressing. Model input parameters and structure were informed by the 1978-1984 Ostergotland county breast screening randomised controlled trial. Overlaid on the natural history model is the effect of screening on diagnosis. Parameters were estimated using Bayesian methods. Markov chain Monte Carlo integration was used to sample the resulting posterior distribution. RESULTS: The breast cancer incidence rate in the Ostergotland population was 21 (95% CI: 17-25) per 10 000 woman-years. Accounting for length-biased sampling, an estimated 91% (95% CI: 85-97%) of breast cancers were aggressive. Larger tumours, 21-50 mm, had an average sojourn of 6 years (95% CI: 3-16 years), whereas aggressive ductal carcinomas in situ took around half a month (95% CI: 0-1 month) to progress to the invasive ≤10 mm state. CONCLUSION: These tumour progression rate estimates may facilitate future work analysing cost-effectiveness and quality-adjusted life years for various screening strategies.

Predicting preference-based SF-6D index scores from the SF-8 health survey.

PURPOSE: To develop and test functions for predicting the preference-based SF-6D index scores from the SF-8 health survey. METHODS: This study was a secondary analysis of data collected in a population health survey in which respondents (n = 7,529) completed both the SF-36 and the SF-8 questionnaires. We examined seven ordinary least-square estimators for their performance in predicting SF-6D scores from the SF-8 at both the individual and the group levels. RESULTS: In general, all functions performed similarly well in predicting SF-6D scores, and the predictions at the group level were better than predictions at the individual level. At the individual level, 42.5-51.5% of prediction errors were smaller than the minimally important difference (MID) of the SF-6D scores, depending on the function specifications, while almost all prediction errors of the tested functions were smaller than the MID of SF-6D at the group level. At both individual and group levels, the tested functions predicted lower than actual scores at the higher end of the SF-6D scale. CONCLUSIONS: Our study developed functions to generate preference-based SF-6D index scores from the SF-8 health survey, the first of its kind. Further research is needed to evaluate the performance and validity of the prediction functions.

Associations between complications and health-related quality of life in individuals with diabetes.

OBJECTIVE: Type 2 diabetes and associated complications adversely affect health-related quality of life (HRQoL). However, it is unclear whether different complications have the same or different associations with HRQoL. We examined associations between retinopathy, nephropathy, peripheral neuropathy (microvascular), coronary heart disease, stroke and peripheral arterial disease (macrovascular) in diabetes and HRQoL. DESIGN: This study was a follow-up examination between 2004 and 2007 of participants from four previous cross-sectional population-based studies in Singapore. METHODS: Health-related quality of life was assessed through self-administered SF-36 health survey version 2. Diabetes and complications status were assessed through self-report, clinical and laboratory examinations. About 2601 individuals, 2205 healthy and 396 with diabetes, were studied. RESULTS: Lower physical component scores (PCS) were associated with microvascular (2.96 points, P < 0.001) and both macro- and microvascular complications (4.67 points, P < 0.001), but not diabetes alone. Coronary heart disease (3.86 points, P = 0.007), peripheral neuropathy (11.46 points, P < 0.001) and severe retinopathy (4.46 points, P < 0.001) were associated with lower PCS. The greatest reduction in scores was seen in peripheral neuropathy. CONCLUSIONS: Quality of life in patients with diabetes is affected mainly by presence of complications, and not diabetes per se. Peripheral neuropathy was associated with the greatest reduction in quality of life. Improved management to prevent or delay onset of complications may reduce the effect on quality of life in patients with diabetes.

Estimating the lifetime economic burden of Parkinson's disease in Singapore.

BACKGROUND AND PURPOSE: We aimed to estimate the lifetime cost of Parkinson's disease (PD) from the societal perspective. METHODS: A convenience sample of English or Chinese-speaking patients with PD was recruited from a PD and Movement Disorders Centre in Singapore to complete a financial burden questionnaire. Sociodemographic and clinical data were retrieved from hospital databases. Markov cohort model analysis was performed (cycle length, 1-year; duration, death or reached 100 years old). Patients were assumed to progress from one Markov state to the next state or death without skipping states or regressing. All model parameters were based on published local data. RESULTS: In 195 patients with PD (median age: 68.9, male: 51.8%), the simulated lifetime cost of PD was Singapore Dollar (SGD) 60,487 (EUR purchasing power parity 56,253) per patient. Direct medical, non-medical and indirect cost accounted for 18.8%, 12.8% and 68.4% of total lifetime cost, respectively. The top three components of total lifetime cost were productivity losses (67.6%), pharmacotherapy (11.4%) and home care (8.7%). One-way sensitivity analysis and probabilistic sensitivity analyses revealed that estimates were sensitive to cost at H&Y stage 1, 2 and 2.5 and productivity losses. CONCLUSIONS: The lifetime cost of PD is evaluated for the first time. This cost is substantial and comparable to the lifetime cost of intracerebral haemorrhage in at least one study. Our study identified several priority areas for research and policy formulation: reducing productivity losses, reducing cost of pharmacotherapy, avoiding hospitalization and reducing home care cost.

Economic burden of Parkinson's disease in Singapore.

BACKGROUND: This study was carried out to evaluate the economic burden of Parkinson's disease (PD) and factors independently associated with individual components of total cost in Singapore. METHODS: A consecutive sample of 195 patients with PD (mean age: 68.2, men: 51.8%) attending a tertiary neuroscience clinic were identified and interviewed using standardized questionnaires including a financial burden questionnaire, two Health Related Quality of Life (HRQoL) questionnaires and the Beck Depression Inventory questionnaire. RESULTS: Annual total cost of PD from a societal perspective was SGD11345 (USD10129) per patient, with direct cost accounted for 38.5% and indirect cost 61.5%. The main cost components for direct medical cost, direct non-medical cost, and indirect cost was pharmacotherapy (50.4%), home care (76.1%), and productivity loss (97.9%), respectively. In multiple linear regression analysis, higher education, younger age and longer duration of PD were associated with higher total cost. CONCLUSIONS: Parkinson's disease exerts a considerable burden on patients, health care system and society in Singapore. As productivity loss accounts for a large share of the economic burden imposed by PD, treatments and health care programmes with potential for returning patients to higher productivity are urgently needed.

Selegiline use is associated with a slower progression in early Parkinson's disease as evaluated by Hoehn and Yahr Stage transition times.

This study was carried out to evaluate the association between selegiline use and Parkinson's disease (PD) progression in a clinical sample by evaluating modified Hoehn and Yahr Stage (H&Y) stage transition times. Data were obtained from the movement disorder database of the National Neuroscience Institute in Singapore. Cox regression analysis was used to examine the association between baseline variables and H&Y stage transition times. In multi-variate Cox regression analysis, patients who were of younger age, shorter PD duration, lower Unified Parkinson's Disease Rating Scale (UPDRS) motor scores, on selegiline treatment (≥ 3 years) and not on COMT inhibitors were associated with longer transition times from stage 2-2.5. Patients who were treated with selegiline (≥ 3 years) and not on COMT inhibitors experienced longer transition times from stage 2.5-3. In conclusion, selegiline use for 3 years or more in early PD was associated with a slower progression of PD as evaluated by H&Y transition times.

Factors associated with health services utilization in patients with systemic lupus erythematosus: a systematic review.

OBJECTIVES: SLE patients require varying levels of health services since disease severity and activity differ among individuals. Understanding the factors associated with health service utilisation would be useful in improving equitable access. It would also help to identify modifiable factors and current good practices so as to improve quality of care and thus reduce utilisation. Thus, the objective of this review is to identify factors associated with health services utilisation. METHODS: Five electronic databases (PubMed, PsycINFO, EMBASE, International Pharmaceutical Abstract, Web of Science) and bibliographies of short-listed articles were searched. All indicators of health service utilisation (physician and specialist visits, hospitalisations, direct costs) and alternative medicine utilisation were accepted as outcomes in primary studies. Two authors independently selected the studies based on pre-specified inclusion and exclusion criteria. RESULTS: Of 1,276 papers retrieved from electronic and hand searches, 25 were finally selected and reviewed in totality, of which 13 were cross-sectional, 5 were prospective, and 7 were retrospective studies. A variety of service types (e.g. outpatient visits, hospitalisations, etc.) and factors (e.g. demographic, socioeconomic, laboratory indices, etc.) were evaluated. Type of health insurance, poorer physical functioning and greater disease severity were found to be associated with higher utilisation across several studies. CONCLUSION: Modifying the choice or coverage of health insurance plans of SLE patients is a possible option in improving equitable access. Better management of patient reported outcomes such as physical functioning and timely management of SLE to reduce disease severity may reduce health services utilisation in the long term.

Association of body mass index with Short-Form 36 physical and mental component summary scores in a multiethnic Asian population.

OBJECTIVES: To investigate the association between body mass index (BMI) and physical and mental health-related quality of life (HRQoL) in a multiethnic Asian population in Singapore, and explore whether there were gender and ethnic differences in this association. METHODS: We conducted cross-sectional analyses using data from 5027 Chinese, Malay and Indian participants (2403 men and 2624 women) aged 24-95 years. These subjects were from four previous cross-sectional surveys carried out in Singapore (from 1982 to 1998) who attended a follow-up examination (including both a questionnaire and a clinic examination) between 2004 and 2007, during which HRQoL was assessed. Participants were classified as underweight (<18.5 kg m(-2)), normal weight (18.5 to <23 kg m(-2)), overweight (23 to <25 kg m(-2)), moderate obese (25 to <30 kg m(-2)) and severe obese (>or=30 kg m(-2)). HRQoL was measured using the Short-Form 36-item questionnaire (SF-36) physical component summary score (PCS) and mental component summary score (MCS). Linear regressions with and without adjusting for other covariates were used to evaluate the association between BMI and SF-36 PCS and MCS. RESULTS: Compared with participants with normal weight, moderate or severe obesity was associated with 0.8 points (95% confidence interval (CI): -1.5 to -0.1, P=0.03) and 2.1 points lower PCS (95% CI: -3.1 to -0.1, P<0.001), respectively, after adjustment for sociodemographic variables, family functioning measure scores and the presence of chronic diseases. These associations were greater in women than in men. In contrast, being underweight was associated with 1.3 points lower MCS (95% CI: -2.3 to -0.3, P=0.014). CONCLUSIONS: In this study (one of few studies in the Asia-Pacific region), obesity was associated with lower PCS and the effect was modified by gender but not ethnicity, such that the association was greater in women than in men. However, obesity was not associated with MCS. Underweight was associated with reduced MCS but not PCS.

Computerized administration of health-related quality of life instruments compared to interviewer administration may reduce sample size requirements in clinical research: a pilot randomized controlled trial among rheumatology patients.

OBJECTIVES: Computerized health-related quality of life (HRQoL) administration may facilitate clinical trials incorporating HRQoL assessment in rheumatology patients by reducing sample size requirements. We tested this hypothesis in a pilot randomized controlled trial. METHODS: Chinese-speaking adult rheumatology outpatients were randomized to computerized (PC) or interviewer (IA) administration of the EQ-5D (utility & VAS), Health Utilities Index (HUI2 & HUI3) and Family Functioning Measure (FFM). We compared measurement variability (i.e., variance) between PC and IA for each instrument before (Levene's test) and after adjusting for the effects of age, gender and education (multivariable modeling) and computed the variance ratio (VR) for PC over IA. RESULTS: In 138 patients (mean age: 48), the mean (SD) time for administration was similar for PC (n = 67) and IA (n = 71) at 17.7 (7.94) versus 17.3 minutes (7.49), respectively. More subjects expressed a preference for PC (n = 21) over IA (n = 13). Mean HRQoL scores were not significantly different for PC versus IA except for higher VAS scores with IA (difference -7.7, 95% CI -14.0 to 1.3, p = 0.018). Variances and adjusted VR were smaller with PC for the EQ-5D (adjusted VR 0.34, 95% CI 0.18 to 0.65), HUI3 (0.49, 0.27 to 0.89) and FFM (0.95, 0.61 to 1.46), but larger for the HUI2 (1.30, 0.67 to 2.55) and VAS (1.05, 0.55 to 2.00). CONCLUSION: The reduced variability in 3 of 5 instruments and good acceptance of computerized HRQoL assessment, if confirmed in larger studies, may lead to smaller sample size requirements, with potential reductions in cost and recruitment time for clinical trials and cohort studies.

Meaning of health-related quality of life among children and adolescents in an Asian country: a focus group approach.

AIMS: We aimed to evaluate the extent to which HRQoL instruments developed based on the Western notion of health is applicable to Asian children and adolescents by assessing their conceptualization of QoL. A secondary objective is to evaluate the necessity of developing age- or gender-specific HRQoL instruments. METHODS: We explored the meaning of general and health-related QoL through focus group discussions in Singapore, a multi-ethnic Asian society. Two investigators independently analysed the data. They extracted major and sub-themes related to both general and health-related QoL. The agreement between the analyses was compared and disagreement was resolved through discussion. RESULTS: Thirty-two subjects (children: 50.0%, female: 50.0%) participated. There were few disagreements. Meanings of general and health-related QoL could be grouped under three broad themes: (1) physical, (2) psychological and (3) social health, consistent with the current definition of HRQoL. We found that Singaporean and Western children/adolescents share a remarkably similar notion of general and health-related QoL. Compared to adolescents, children were more likely to report positive emotions, be less mindful of others' opinions and had less varied social activities. CONCLUSION: The results suggest that currently available instruments are potentially useful for Singaporean children/adolescents. We also found that age-specific HRQoL instruments are necessary.

Validation of the English version of the KINDL generic children's health-related quality of life instrument for an Asian population--results from a pilot test.

OBJECTIVES: To evaluate the psychometric properties of the KINDL questionnaire in an Asian population. METHODS: Consecutive patients with diabetes mellitus (DM) and healthy subjects were recruited to complete the English KINDL questionnaire. The inclusion criteria for patients were age 8-16 years, English-speaking, diagnosed with DM and absence of co-morbid conditions. RESULTS: Thirty children with DM (mean age: 10.7 +/- 1.35 years; 11 M) and 39 healthy subjects (mean age: 10.6 +/- 1.23 years, 17M) completed the child version whereas 31 adolescents with DM (mean age: 14.5 +/- 1.48 years; 15M) and 32 healthy subjects (mean age: 14.3 +/- 0.87 years, 16M) completed the adolescent version. Overall, children with DM reported better HRQoL than healthy children. Although this appeared counter-intuitive, several explanations are possible: (1) the development of resilience to the disease over time, (2) our subjects are well-managed, (3) response shift, (4) the provision of high quality medical care, (5) compared to normal children, diabetic subjects and their family pay greater attention to health issues. The reliability coefficients were (overall, scales): KINDL-Kid DM (0.79, 0.44-0.65), KINDL-Kid Healthy (0.71,0.60-0.80), KINDL-Kiddo DM (0.77, 0.37-0.74) and KINDL-Kiddo Healthy (0.84, 0.21-0.79). CONCLUSIONS: The KINDL questionnaire appeared promising for use in Asian children. However, further validation in a sample more representative of the general population is required.