Doris Young

CONTEXT: Improving vitamin D status may be an important modifiable risk factor to reduce falls and fractures; however, adherence to daily supplementation is typically poor. OBJECTIVE: To determine whether a single annual dose of 500,000 IU of cholecalciferol administered orally to older women in autumn or winter would improve adherence and reduce the risk of falls and fracture. DESIGN, SETTING, AND PARTICIPANTS: A double-blind, placebo-controlled trial of 2256 community-dwelling women, aged 70 years or older, considered to be at high risk of fracture were recruited from June 2003 to June 2005 and were randomly assigned to receive cholecalciferol or placebo each autumn to winter for 3 to 5 years. The study concluded in 2008. INTERVENTION: 500,000 IU of cholecalciferol or placebo. MAIN OUTCOME MEASURES: Falls and fractures were ascertained using monthly calendars; details were confirmed by telephone interview. Fractures were radiologically confirmed. In a substudy, 137 randomly selected participants underwent serial blood sampling for 25-hydroxycholecalciferol and parathyroid hormone levels. RESULTS: Women in the cholecalciferol (vitamin D) group had 171 fractures vs 135 in the placebo group; 837 women in the vitamin D group fell 2892 times (rate, 83.4 per 100 person-years) while 769 women in the placebo group fell 2512 times (rate, 72.7 per 100 person-years; incidence rate ratio [RR], 1.15; 95% confidence interval [CI], 1.02-1.30; P = .03). The incidence RR for fracture in the vitamin D group was 1.26 (95% CI, 1.00-1.59; P = .047) vs the placebo group (rates per 100 person-years, 4.9 vitamin D vs 3.9 placebo). A temporal pattern was observed in a post hoc analysis of falls. The incidence RR of falling in the vitamin D group vs the placebo group was 1.31 in the first 3 months after dosing and 1.13 during the following 9 months (test for homogeneity; P = .02). In the substudy, the median baseline serum 25-hydroxycholecalciferol was 49 nmol/L. Less than 3% of the substudy participants had 25-hydroxycholecalciferol levels lower than 25 nmol/L. In the vitamin D group, 25-hydroxycholecalciferol levels increased at 1 month after dosing to approximately 120 nmol/L, were approximately 90 nmol/L at 3 months, and remained higher than the placebo group 12 months after dosing. CONCLUSION: Among older community-dwelling women, annual oral administration of high-dose cholecalciferol resulted in an increased risk of falls and fractures. TRIAL REGISTRATION: anzctr.org.au Identifier: ACTRN12605000658617; isrctn.org Identifier: ISRCTN83409867.

BACKGROUND: The use of blended payment schemes in primary care, including the use of financial incentives to directly reward 'performance' and 'quality' is increasing in a number of countries. There are many examples in the US, and the Quality and Outcomes Framework (QoF) for general practitioners (GPs) in the UK is an example of a major system-wide reform. Despite the popularity of these schemes, there is currently little rigorous evidence of their success in improving the quality of primary health care, or of whether such an approach is cost-effective relative to other ways to improve the quality of care. OBJECTIVES: The aim of this review is to examine the effect of changes in the method and level of payment on the quality of care provided by primary care physicians (PCPs) and to identify:i) the different types of financial incentives that have improved quality;ii) the characteristics of patient populations for whom quality of care has been improved by financial incentives; andiii) the characteristics of PCPs who have responded to financial incentives. SEARCH STRATEGY: We searched the Cochrane Effective Practice and Organisation of Care (EPOC) Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) and Cochrane Database of Systematic Reviews (CDSR) (The Cochrane Library), MEDLINE, HealthSTAR, EMBASE, CINAHL, PsychLIT, and ECONLIT. Searches of Internet-based economics and health economics working paper collections were also conducted. Finally, studies were identified through the reference lists of retrieved articles, websites of key organisations, and from direct contact with key authors in the field. Articles were included if they were published from 2000 to August 2009. SELECTION CRITERIA: Randomised controlled trials (RCT), controlled before and after studies (CBA), and interrupted time series analyses (ITS) evaluating the impact of different financial interventions on the quality of care delivered by primary healthcare physicians (PCPs). Quality of care was defined as patient reported outcome measures, clinical behaviours, and intermediate clinical and physiological measures. DATA COLLECTION AND ANALYSIS: Two review authors independently extracted data and assessed study quality, in consultation with two other review authors where there was disagreement. For each included study, we reported the estimated effect sizes and confidence intervals. MAIN RESULTS: Seven studies were included in this review. Three of the studies evaluated single-threshold target payments, one examined a fixed fee per patient achieving a specified outcome, one study evaluated payments based on the relative ranking of medical groups' performance (tournament-based pay), one study examined a mix of tournament-based pay and threshold payments, and one study evaluated changing from a blended payments scheme to salaried payment. Three cluster RCTs examined smoking cessation; one CBA examined patients' assessment of the quality of care; one CBA examined cervical screening, mammography screening, and HbA1c; one ITS focused on four outcomes in diabetes; and one controlled ITS (a difference-in-difference design) examined cervical screening, mammography screening, HbA1c, childhood immunisation, chlamydia screening, and appropriate asthma medication. Six of the seven studies showed positive but modest effects on quality of care for some primary outcome measures, but not all. One study found no effect on quality of care. Poor study design led to substantial risk of bias in most studies. In particular, none of the studies addressed issues of selection bias as a result of the ability of primary care physicians to select into or out of the incentive scheme or health plan. AUTHORS' CONCLUSIONS: The use of financial incentives to reward PCPs for improving the quality of primary healthcare services is growing. However, there is insufficient evidence to support or not support the use of financial incentives to improve the quality of primary health care. Implementation should proceed with caution and incentive schemes should be more carefully designed before implementation. In addition to basing incentive design more on theory, there is a large literature discussing experiences with these schemes that can be used to draw out a number of lessons that can be learned and that could be used to influence or modify the design of incentive schemes. More rigorous study designs need to be used to account for the selection of physicians into incentive schemes. The use of instrumental variable techniques should be considered to assist with the identification of treatment effects in the presence of selection bias and other sources of unobserved heterogeneity. In randomised trials, care must be taken in using the correct unit of analysis and more attention should be paid to blinding. Studies should also examine the potential unintended consequences of incentive schemes by having a stronger theoretical basis, including a broader range of outcomes, and conducting more extensive subgroup analysis. Studies should more consistently describe i) the type of payment scheme at baseline or in the control group, ii) how payments to medical groups were used and distributed within the groups, and iii) the size of the new payments as a percentage of total revenue. Further research comparing the relative costs and effects of financial incentives with other behaviour change interventions is also required.

This cross-sectional twin study aimed to quantify the roles of constitutional and lifestyle factors on bone mass in adolescent and young adult women. Areal bone density (BMD) at the lumbar spine, femoral neck, Ward's triangle, and total hip, total body bone mineral content (BMC), and lean mass and fat mass were measured using dual energy X-ray absorptiometry (DXA) in 215 female volunteer twin pairs (122 monozygotic [MZ], 93 dizygotic [DZ]) aged 10 to 26 years. Height, weight, menarchial history, dietary calcium intake, physical activity, current tobacco use, and alcohol consumption were determined by questionnaire. Mean BMD increased with age to around 16 years, when it reached a plateau. Within-pair differences in BMD at the lumbar spine (expressed as a percentage of the pair mean BMD) were univariately associated with pair differences in menarchial status (14 +/- 3%), height (0.7 +/- 0.1% per cm), weight (0.4 +/- 0.1% per kg), lean mass (1.0 +/- 0.1% per kg), and fat mass (0.5 +/- 0.1% per kg). Only menarchial status, height, and lean mass, however, were independent predictors. At the proximal femoral sites, within-pair BMD differences were associated with within-pair lean mass differences (1.0 to 1.1 +/- 0.2%/kg), and no other factor was significant. The same conclusions applied to within-pair differences in BMD/height. Total body BMC was independently associated with menarchial status, height, lean mass, and fat mass; the effects of the latter two variables were stronger in pairs both premenarchial. After adjusting for constitutional factors, no lifestyle factor was independently predictive. By reducing collinearity, the cotwin method clearly identified that lean mass, not fat mass, was the major independent determinant of bone mass at the hip, both pre- and postmenarche.