Why Are Outcomes Different for Registry Patients Enrolled Prospectively and Retrospectively? Insights from the Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF).

Background: Retrospective and prospective observational studies are designed to reflect real-world evidence on clinical practice, but can yield conflicting results. The GARFIELD-AF Registry includes both methods of enrolment and allows analysis of differences in patient characteristics and outcomes that may result. Methods and Results: Patients with atrial fibrillation (AF) and ≥1 risk factor for stroke at diagnosis of AF were recruited either retrospectively (n = 5069) or prospectively (n = 5501) from 19 countries and then followed prospectively. The retrospectively enrolled cohort comprised patients with established AF (for a least 6, and up to 24 months before enrolment), who were identified retrospectively (and baseline and partial follow-up data were collected from the emedical records) and then followed prospectively between 0-18 months (such that the total time of follow-up was 24 months; data collection Dec-2009 and Oct-2010). In the prospectively enrolled cohort, patients with newly diagnosed AF (≤6 weeks after diagnosis) were recruited between Mar-2010 and Oct-2011 and were followed for 24 months after enrolment. Differences between the cohorts were observed in clinical characteristics, including type of AF, stroke prevention strategies, and event rates. More patients in the retrospectively identified cohort received vitamin K antagonists (62.1% vs. 53.2%) and fewer received non-vitamin K oral anticoagulants (1.8% vs . 4.2%). All-cause mortality rates per 100 person-years during the prospective follow-up (starting the first study visit up to 1 year) were significantly lower in the retrospective than prospectively identified cohort (3.04 [95% CI 2.51 to 3.67] vs . 4.05 [95% CI 3.53 to 4.63]; p = 0.016). Conclusions: Interpretations of data from registries that aim to evaluate the characteristics and outcomes of patients with AF must take account of differences in registry design and the impact of recall bias and survivorship bias that is incurred with retrospective enrolment. Clinical Trial Registration: - URL: http://www.clinicaltrials.gov . Unique identifier for GARFIELD-AF (NCT01090362)

Risk profiles and one-year outcomes of patients with newly diagnosed atrial fibrillation in India: Insights from the GARFIELD-AF Registry.

BACKGROUND: The Global Anticoagulant Registry in the FIELD-Atrial Fibrillation (GARFIELD-AF) is an ongoing prospective noninterventional registry, which is providing important information on the baseline characteristics, treatment patterns, and 1-year outcomes in patients with newly diagnosed non-valvular atrial fibrillation (NVAF). This report describes data from Indian patients recruited in this registry. METHODS AND RESULTS: A total of 52,014 patients with newly diagnosed AF were enrolled globally; of these, 1388 patients were recruited from 26 sites within India (2012-2016). In India, the mean age was 65.8 years at diagnosis of NVAF. Hypertension was the most prevalent risk factor for AF, present in 68.5% of patients from India and in 76.3% of patients globally (P < 0.001). Diabetes and coronary artery disease (CAD) were prevalent in 36.2% and 28.1% of patients as compared with global prevalence of 22.2% and 21.6%, respectively (P < 0.001 for both). Antiplatelet therapy was the most common antithrombotic treatment in India. With increasing stroke risk, however, patients were more likely to receive oral anticoagulant therapy [mainly vitamin K antagonist (VKA)], but average international normalized ratio (INR) was lower among Indian patients [median INR value 1.6 (interquartile range {IQR}: 1.3-2.3) versus 2.3 (IQR 1.8-2.8) (P < 0.001)]. Compared with other countries, patients from India had markedly higher rates of all-cause mortality [7.68 per 100 person-years (95% confidence interval 6.32-9.35) vs 4.34 (4.16-4.53), P < 0.0001], while rates of stroke/systemic embolism and major bleeding were lower after 1 year of follow-up. CONCLUSION: Compared to previously published registries from India, the GARFIELD-AF registry describes clinical profiles and outcomes in Indian patients with AF of a different etiology. The registry data show that compared to the rest of the world, Indian AF patients are younger in age and have more diabetes and CAD. Patients with a higher stroke risk are more likely to receive anticoagulation therapy with VKA but are underdosed compared with the global average in the GARFIELD-AF. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01090362

A methodological framework to derive the cost of the GP consultation

With an emphasis on a primary care-led NHS, the cost of a GP consultation will be a major element in any economic analysis. No standardized methodology is available for deriving this cost, and there are a wide range of estimates. Wherever possible, local unit costs should be derived from individual practice information, particularly when local circumstances are relevant to a study, but unless standardized methodology is used, studies undertaken in different settings or at different times will not be compatible. This paper proposes a framework which will enable each practice to determine their unit consultation costs and offers data that can be used where local information is not available

The Impact of Health Economics on Healthcare Delivery: A Primary Care Perspective

With the increasing emphasis on providing efficient and equitable services from primary care and against a background of increasing demands on limited resources, economic theory seeks to facilitate both the direction of primary care and the decisions that are made within it. This paper argues that the impact of health economics, particularly at the microeconomic level, has been limited. This is because health economists have failed to recognise the importance of context, and also reflects their attempts to force reality into a disciplinary matrix which is not always accessible and acceptable to end users. Argument is made for a closer relationship between health economists and those who commission and deliver primary care. It is also desirable to develop pragmatic decision-making frameworks which draw upon economic concepts and principles but reflect the realities of the environment in which they are applied.Health economics, Pharmacoeconomics

Guidance for the management of headache in sport on behalf of The Royal College of General Practitioners and The British Association for the Study of Headache

Headache is prevalent within the community and can have an impact on sport in both the amateur and elite player, either coincidentally or as a direct result of participation. Against a background of a limited evidence base, this paper suggests how headache can be classified within this context and offers guidance for treating both the amateur and elite athlete. The impact of headache in sport may be unrecognised and undertreated, and further research is needed in this area. </jats:p

What does it cost the patient to see the doctor?

Against a background of increasing demands on limited resources, there will be an emphasis on undertaking studies that relate benefits of an intervention to the costs that are incurred in their production. Patient costs are an important, but often overlooked, part of an economic exercise and include transport costs, loss of employment, and loss of leisure time. This paper highlights the theoretical difficulties inherent in deriving patient costs and suggests a pragmatic framework to derive unit costs in these areas. We demonstrate that these costs are not inconsiderable when compared with the cost of a general practitioner consultation