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BACKGROUND: Approximately 210 million people are estimated to have chronic obstructive pulmonary disease [COPD] worldwide. The burden of disease is known to be high, though less is known about those of a younger age. The aim of this study was to investigate the wider personal, economic and societal burden of COPD on a cross country working-age cohort.
METHODS: A cross-country [Brazil, China, Germany, Turkey, US, UK] cross-sectional survey methodology was utilised to answer the research questions. 2426 participants aged 45-67 recruited via a number of recruitment methods specific to each country completed the full survey. Inclusion criteria were a recalled physician diagnosis of COPD, a smoking history of > 10 pack years and the use of COPD medications in the previous 3 months prior to
questioning. The survey included items from the validated Work Productivity and Activity Impairment [WPAI] scale and the EuroQoL 5 Dimension [EQ-5D] scale. Disease severity was measured using the 5-point MRC [Medical Research Council] dyspnoea scale as a surrogate measure.
RESULTS: 64% had either moderate [n = 1012] or severe [n = 521] COPD, although this varied by country. 75% of the cohort reported at least one comorbid condition. Quality of life declined with severity of illness [mild, mean EQ-5D score = 0.84; moderate 0.58; severe 0.41]. The annual cost of healthcare utilisation [excluding treatment costs and diagnostic tests] per individual was estimated to be $2,364 [£1,500]. For those remaining in active employment [n: 677]: lost time from work cost the individual an average of $880 [£556] per annum and lifetime losses of $7,365 [£4,661] amounting to $596,000 [£377,000] for the cohort. 447 [~40%] of the working population had retired prematurely because of COPD incurring individual estimated lifetime income losses of $316,000 [£200,000] or a combined total of $141 m [£89.6 m]. As the mean age of retirees was 58.3 and average time since retirement was 4 years, this suggests the average age of retirement is around 54. This would mean a high societal and economic impact in all study countries, particularly where typical state retirement ages are higher, for example in Brazil, Germany and the UK [65] and the US [65,66,67], compared to Turkey [58 for women, 60 for men] and China [60].
CONCLUSIONS: Although generalisation across a broader COPD population is limited due to the varied participant recruitment methods, these data nevertheless suggest that COPD has significant personal, economic and societal burden on working age people. Further efforts to improve COPD diagnosis and management are required.
Secondary use of patient databases is essential in healthcare if clinical trials are to progress efficiently to planned time and target and imperative if the planned UK expansion of research and development (R&D) at point of care is to be achieved. Integration of effective databases primarily designed to facilitate patient care with R&D requirements is needed but represents a complex challenge.
We present a system that achieves an integrated approach with online management of complex datasets for clinical trials within care records using a specific study as an example to show functionality in practice; illustrating how this system provides an ideal resource to meet the needs of both clinicians and researchers.
BACKGROUND: Quality measures should be subjected to a testing protocol before being used in practice using key attributes such as acceptability, feasibility and reliability, as well as identifying issues derived from actual implementation and unintended consequences. We describe the methodologies and results of an indicator testing protocol (ITP) using data from proposed quality indicators for the United Kingdom Quality and Outcomes Framework (QOF).
METHODS: The indicator testing protocol involved a multi-step and methodological process: 1) The RAND/UCLA Appropriateness Method, to test clarity and necessity, 2) data extraction from patients' medical records, to test technical feasibility and reliability, 3) diaries, to test workload, 4) cost-effectiveness modelling, and 5) semistructured interviews, to test acceptability, implementation issues and unintended consequences. Testing was conducted in a sample of representative family practices in England. These methods were combined into an overall recommendation for each tested indicator.
RESULTS: Using an indicator testing protocol as part of piloting was seen as a valuable way of testing potential indicators in 'real world' settings. Pilot 1 (October 2009-March 2010) involved thirteen indicators across six clinical domains and twelve indicators passed the indicator testing protocol. However, the indicator testing protocol identified a number of implementation issues and unintended consequences that can be rectified or removed prior to national roll out. A palliative care indicator is used as an exemplar of the value of piloting using a multiple attribute indicator testing protocol - while technically feasible and reliable, it was unacceptable to practice staff and raised concerns about potentially causing actual patient harm.
CONCLUSIONS: This indicator testing protocol is one example of a protocol that may be useful in assessing potential quality indicators when adapted to specific country health care settings and may be of use to policy-makers and researchers worldwide to test the likely effect of implementing indicators prior to roll out. It builds on and codifies existing literature and other testing protocols to create a field testing methodology that can be used to produce country specific quality indicators for pay-for-performance or quality improvement schemes.
AIMS: To compare the intra- and inter-assessor agreement and operator preference of a modified (four-grade) quality rating system for dental radiographs with the current National Radiological Protection Board (NRPB) (three-grade) quality rating system.
METHODS: Sixty radiographic images of varying quality were selected by retrospective review of dental records from a general dental practice. The images were sorted into groups to represent examples of radiographic quality (1=excellent, 2=diagnostically acceptable, 3=diagnostically compromised, 4=unacceptable). A 'gold standard' for radiological quality assessment was provided by a consultant in dental and maxillofacial radiology. A compact disc (CD) of the 60 images was produced and posted to a panel of 14 general dental practitioners (GDPs) who were asked to grade the quality of the images using two different systems on two occasions separated by a washout period of two days. The practitioners graded the radiographs using the currently accepted method for assessing radiographic quality (the three-grade NRPB system) and the alternative four-grade system. The quality of the images on the CD was deemed appropriate by the consultant.
RESULTS: The strength of inter-assessor agreement was weaker when using a four-grade system in comparison to a three-grade system, reducing to a mean of k=0.51 from a mean of k=0.61 when using the original grading system. Mean agreement did not fall below 'moderate agreement' (k=0.41-0.60). Eleven of the 14 GDPs preferred the four-grade system.
CONCLUSION: The GDPs who participated in this study preferred the four-grade system to the three-grade system when comparing the quality of dental radiographs. However, the strength of agreement was weaker when using the four-grade system in comparison to the three-grade system. Overall, the results are equivocal. However, they should help to inform specialist dental radiology panels, should revision of quality grading be undertaken in the future.
AIMS: To determine the incremental cost effectiveness of nicotine replacement therapy (NRT), bupropion and varenicline for preventing relapse to smoking when used by abstinent smokers
DESIGN SETTING AND PARTICIPANTS: Cohort simulation and sensitivity analyses combining cost and health service data with systematic review estimates for the effectiveness of NRT, bupropion and varenicline when used by abstinent quitters to prevent their relapse to smoking.
MEASUREMENTS: Incremental health gain in Quality Adjusted Life Years (QALYs) generated by each drug compared to 'no intervention'.
FINDINGS: Bupropion resulted in an incremental QALY increase of 0.07 with a concurrent cost saving of £68; NRT and varenicline both caused incremental QALYs increases of 0.04 at costs of £12 and £90 respectively, although varenicline findings were based on data from a single clinical trial and require cautious interpretation. Even after extensive sensitivity analyses with substantial varying of key model parameters, cost effectiveness of all drugs remained. Cost effectiveness ratios only exceeded the UK National Institute of Clinical Excellence (NICE) benchmark of £20 000 per QALY when drug treatment effects were postulated to last for no longer than 1 year; or, for NRT and varenicline, efficacy was reduced to 10% of that observed in clinical trials.
CONCLUSION: Bupropion, nicotine replacement therapy and varenicline appear cost effective at preventing relapse to smoking by smokers who are in quit attempts and have recently become abstinent; they have comparable cost effectiveness to smoking cessation interventions. Widespread use of these effective relapse prevention treatments could promote substantial health gain at an acceptable cost to health providers.
PURPOSE: The SD-16 is a 16-item instrument assessing social distress in cancer patients. In addition to work underlining the scale's reliability, validity and clinical utility, recent research has also determined minimally important differences (MID) for the instrument. The aim of this study was to assess whether item locations remained stable over time, in order to support the longitudinal use of the instrument.
METHODS: Data were collated from cancer patients (N = 123) who had completed the SD-16 at four time points (baseline, 6 months, 1 and 2 years). The Partial Credit Model (Rasch analysis) was applied to the data and item fit evaluated against published criteria. Measurement invariance of item location and person measures over time was assessed using analysis of variance.
RESULTS: Good item fit was found with the exception of one item ("work"), which demonstrated misfit at two time points. No statistically significant differences were found for item locations. As anticipated, there were changes over time in patients' scores, particularly in the first 6 months.
CONCLUSIONS: The instrument can be used longitudinally to accurately assess changes in cancer patients' social distress.
There is a new merging of health economics and nutrition disciplines to assess the impact of diet on health and disease prevention and to characterise the health and economic aspects of specific changes in nutritional behaviour and nutrition recommendations. A rationale exists for developing the field of nutrition economics which could offer a better understanding of both nutrition, in the context of having a significant influence on health outcomes, and economics, in order to estimate the absolute and relative monetary impact of health measures. For this purpose, an expert meeting assessed questions aimed at clarifying the scope and identifying the key issues that should be taken into consideration in developing nutrition economics as a discipline that could potentially address important questions. We propose a first multidisciplinary outline for understanding the principles and particular characteristics of this emerging field. We summarise here the concepts and the observations of workshop participants and propose a basic setting for nutrition economics and health outcomes research as a novel discipline to support nutrition, health economics and health policy development in an evidence and health-benefit-based manner.
