AimsTo investigate the rates and risk of hospitalisations in patients with type 2 diabetes (T2D) mellitus in England.MethodsThis retrospective population-based cohort study used computerised records from the General Practice Research Database linked to Hospital Episode Statistics data in England. Patients with T2D from January 2006 to December 2010 were selected. Primary outcome measures were all-cause, non-diabetes-related, diabetes-related and hypoglycaemia-related hospitalisations. Factors associated with all-cause and diabetes-related hospitalisations were investigated with Cox's proportional hazards models.ResultsAmongst 97,689 patients with T2D, approximately 60% had at least one hospitalisation during the 4-year study period. Rates of hospitalisation were as follows: all-cause, 33.9 per 100 patient-years (pt-yrs); non-diabetes-related, 29.1 per 100 pt-yrs; diabetes-related, 18.8 per 100 pt-yrs and hypoglycaemia, 0.3 per 100 pt-yrs. The risk of all-cause hospitalisation increased with hospitalisation in the previous year, insulin use and the presence of major comorbidities. The risk of a diabetes-related hospitalisation increased with age, female gender, insulin use, chronic renal insufficiency, hypoglycaemia (as diagnosed by a general practitioner) and diabetes-related hospitalisation in the previous year.ConclusionsPatients with T2D are hospitalised at a considerably high rate for causes directly related with diabetes complications and stay longer in hospital. History of hospitalisation and complications of diabetes were found to be predictive of inpatient hospitalisations suggesting previous hospitalisation episodes could serve as points of intervention. This study highlights important areas for healthcare intervention and provides a reminder for vigilance when risk factors for hospitalisation in patients with T2D are present.
BackgroundHunter syndrome (mucopolysaccharidosis type II (MPS II)) is a rare metabolic disease that can severely compromise health, well-being and life expectancy. Little evidence has been published on the impact of MPS II on health-related quality of life (HRQL). The objective of this study was to describe this impact using the Hunter Syndrome-Functional Outcomes for Clinical Understanding Scale (HS-FOCUS) questionnaire and a range of standard validated questionnaires previously used in paediatric populations.MethodsClinical and demographic characteristics collected in a clinical trial and responses to four HRQL questionnaires completed both by patients and parents prior to enzyme replacement treatment were used. The association between questionnaire scores and clinical function parameters were tested using Spearman rank-order correlations. Results were compared to scores in other paediatric populations with chronic conditions obtained through a targeted literature search of published studies.ResultsOverall, 96 male patients with MPS II and their parents were enrolled in the trial. All parents completed the questionnaires and 53 patients above 12 years old also completed the self-reported versions. Parents’ and patients’ responses were analysed separately and results were very similar. Dysfunction according to the HS-FOCUS and the CHAQ was most pronounced in the physical function domains. Very low scores were reported in the Self Esteem and Family Cohesion domains in the CHQ and HUI3 disutility values indicated a moderate impact. Scores reported by patients and their parents were consistently lower than scores in the other paediatric populations identified (except the parent-reported Behaviour score); and considerably lower than normative values.ConclusionsThis study describes the impact on HRQL in patients with MPS II and provides a broader context by comparing it with that of other chronic paediatric diseases. Physical function and the ability to perform day-to-day activities were the most affected areas and a considerable impact on the psychological aspects of patients’ HRQL was also found, with a higher level of impairment across most dimensions (particularly Pain and Self Esteem) than that of other paediatric populations. Such humanistic data provide increasingly important support for establishing priorities for health care spending, and as a component of health economic analysis.
IntroductionCommon symptoms for children with Anderson-Fabry Disease (FD) such as acroparaesthesia and gastrointestinal manifestations can only be objectively assessed in patients using a valid instrument. To date, no such instrument exists.MethodsA preliminary 40-item measure of symptoms and experience with FD, the Fabry-specific Paediatric Health and Pain Questionnaire (FPHPQ) was developed, but lacked a formal assessment of its measurement properties. The FPHPQ was used in the Fabry Outcome Survey (FOS), a registry for all patients with a confirmed diagnosis of FD who are receiving agalsidase alfa, or are treatment naïve and who are managed by physicians participating in FOS. After an item analysis to explore how items performed and combined into domains, a battery of psychometric analyses was performed to assess the measurement properties of this new instrument.ResultsEighty-seven children (ages 4-18 years) completed the questionnaire. Twenty-three items in three subscales of the questionnaire emerged: pain associated with heat or exertion, pain associated with cold, and abdominal pain and fatigue symptoms. Internal consistency reliability for all three subscales was good (Cronbach alpha ≥ 0.84). Reliability was equally high for all age groups (4-7, 8-12, and 13-18). Test-retest reliability was high for all three subscales (intraclass correlation coefficient ≥ 0.74). Construct validity was demonstrated by moderate correlation with brief pain inventory (BPI), KINDL, and EQ-5D. Known group validity showed all subscales were able to discriminate between Fabry disease severity groups as classified by above or below median of the FOS MSSI (Mainz Severity Score Index) grade. The heat or exertion subscale was responsive to change in symptoms between responders and non-responders as defined by change in EQ-5D index scores between the first and second visit.ConclusionsPreliminary results indicate that the measurement properties of FPHPQ are valid and reliable for assessing patient-reported symptoms of FD. The questionnaire could be a useful tool for clinicians to understand the progression of disease and monitor treatment effects. FPHPQ will be further validated and refined as the FOS registry is continuously adding more patients.
ObjectivesIn 2013, the Global Initiative for Chronic Obstructive Lung Disease (GOLD) updated the management strategy on COPD based on severity using a combined assessment of symptoms, degree of airflow limitation, and number of exacerbations. This study quantified prevalence and incidence of COPD in the United Kingdom and estimated disease severity by GOLD 2013 categories A/B (low risk) and C/D (high risk).MethodsThe Clinical Practice Research Datalink was used to identify COPD patients ≥40 years. Patient characteristics were described, and prevalence was calculated on December 31, 2013. Five-year incidence (2009–2013) was estimated, with rates standardized using 2011 UK population age and sex. To classify patients by GOLD categories, spirometry results, the modified British Medical Research Council grade, and history of exacerbations were used.ResultsThe prevalent cohort comprised 49,286 patients with COPD with mean age 70 years; 51.0% were male. Overall prevalence was 33.3 per 1,000 persons (95% confidence interval [CI]: 33.1–33.6); 66.4% were classified as GOLD A/B and 33.6% as C/D. The standardized prevalence of GOLD A/B was 21.9 per 1,000 persons (95% CI: 21.7–22.1) and of C/D was 11.1 (95% CI: 10.9–11.2). A total of 27,224 newly diagnosed COPD patients were identified with mean age 67 years at diagnosis; 53.0% were male. Incidence was 2.2 per 1,000 person-years (95% CI: 2.2–2.3); 68.7% were classified in categories A/B and 31.3% in C/D, of which 17.2% did not receive COPD maintenance medication.ConclusionA third of COPD patients in the UK are considered high risk (GOLD 2013 categories C/D), and a third of patients are diagnosed for the first time at these severe stages. Given the progressive nature of the disease, results suggest that closer attention to respiratory symptoms for early detection, diagnosis, and appropriate treatment of COPD in the UK is warranted.
PurposeThe Hunter Syndrome-Functional Outcomes for Clinical Understanding Scale (HS-FOCUS) Questionnaire is a patient and parent-completed disease-specific instrument used in Hunter syndrome (mucopolysaccharidosis II), a rare paediatric progressive multi-systemic lysosomal storage disease. The objective of this study was to shorten the number of items of the Questionnaire to reduce response burden while maintaining its content validity.MethodsData collected in a clinical trial were used. An iterative process helped identifying redundant or low performing items based on content validity and psychometric properties. Validation on the retained items was assessed using patients and parent’s responses in terms of reliability, validity and responsiveness.ResultsThe HS-FOCUS was completed by 49 patients and 84 parents. Items were mainly removed owing to high floor effects, high inter-item correlations (>0.80) or inadequate content. The shortened patient and parent versions (18 and 21 items) each contained five function domains. Internal consistency and test–retest reliability were >0.70 for most domains, except Breathing and School/work. Concurrent validity was demonstrated by significant correlations (>0.30) with similar concepts of previously validated measures. Significant differences were found in all domain scores across levels of disability.ConclusionsThe shortened HS-FOCUS is a reliable, valid and responsive measure, where burden in answering the Questionnaire was reduced without compromising its validity.
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