Doris Young

Annual high-dose oral vitamin D and falls and fractures in older women: A randomized controlled trial

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.

A co-twin study of the effect of calcium supplementation on bone density during adolescence

The effect of calcium supplementation on bone mineral density (BMD) was evaluated in female twin pairs aged 10–17 years with a mean age of 14 years. Forty-two twin pairs (22 monozygotic, 20 dizygotic; (including one monozygotic pair from a set of triplets) completed at least 6 months of the intervention: 37 pairs to 12 months and 28 pairs to 18 months. BMD was measured by dual-energy X-ray absorptiometry (DXA). In a double-blind manner, one twin in each pair was randomly assigned to receive daily a 1000 mg effervescent calcium tablet (Sandocal 1000), and the other a placebo tablet similar in taste and appearance to the calcium supplement but containing no calcium. Compliance (at least 80% tablets consumed), as measured by tablet count, was 85% in the placebo group and 83% in the calcium group over the 18 months of the study, on average increasing dietary calcium to over 1600 mg/day. There was no within-pair difference in the change in height or weight. When the effect of calcium supplementation on BMD was compared with placebo at approximately 6, 12 and 18 months, it was found that there was a 0.015±0.007 g/ cm2 greater increase in BMD (1.62±0.84%) at the spine in those on calcium after 18 months. At the end of the first 6 months there was a significant within-pair difference of 1.53±0.56% at the spine and 1.27±0.50% at the hip. However, there were no significant differences in the changes in BMD after the initial effect over the first 6 months. Therefore, we found an increase in BMD at the spine with calcium supplementation in females with a mean age of 14 years. The greatest effect was seen in the first 6 months; thereafter the difference was maintained, but there was no accelerated increase in BMD associated with calcium supplementation. The continuance of the intervention until the attainment of peak bone mass and follow-up after cessation of calcium supplementation will be important in clarifying the optimal timing for increased dietary calcium and the sustained, long-term effects of this intervention.

Changes in body composition as determinants of longitudinal changes in bone mineral measures in 8 to 26-year-old female twins.

Abstract: Between 1990 and 1998, we conducted a longitudinal study of 286 female twins aged 8 to 25 years at baseline (60 monozygotic (MZ) pairs, 44 dizygotic (DZ) pairs and 78 unpaired twins), measured on average 2.4 times (range 2–6) with an average of 1.8 years between measurements (range 0.7–6.7 years). Areal bone mineral density (ABMD) at the lumbar spine, total hip and femoral neck, total body bone mineral content (BMC), total body soft tissue composition (lean mass and fat mass) were measured by dual-energy X-ray absorptiometry, and height and menarchial status were also recorded. Median annual changes in height were negligible at 4 years post-menarche. During the “linear growth” period up to 4 years post-menarche, ABMD at the lumbar spine, total hip and femoral neck increased with annual change in lean mass by 1.7 (S.E. 0.1), 1.4 (0.1) and 1.0 (0.1) percent per kilogram per year, respectively (all p<0.001), independently of changes in fat mass or height. During the “post-linear growth” period, ABMD at the total hip and femoral neck increased with annual change in fat mass by 0.3 (0.1) and 0.5 (0.1) percent per kilogram per year (all p<0.01), independent of change in lean mass. Annual changes in total body BMC were associated with annual changes in lean mass (1.9 (0.2) percent per kilogram), in fat mass (1.3 (0.2) percent per kilogram) and in height (0.7) (0.2) percent per centimeter) during linear growth, and in fat mass (1.0 (0.1)) and lean mass (0.6 (0.1)) percent per kilogram post-linear growth (all p<0.001). We conclude that changes in bone mineral measures are strongly associated with changes in lean mass during linear growth, while post-linear growth, changes in fat mass are the predominant, although weaker, predictor. These findings suggest that the strong cross-sectional association between bone mineral measures and lean mass is established during growth and development, and that fat mass emerges as a more powerful determinant of bone change in healthy adult females.

Determinants of hip axis length in women aged 10-89 years: a twin study.

Hip axis length (HAL), a measure of femoral geometry, has been shown to predict hip fracture in white women over the age of 67 years, independently of bone mineral density at the femoral neck. A cross-sectional study of 304 pairs of female twins [176 monozygous (MZ) and 128 dizygous (DZ)], aged between 10 and 89 years, was performed to examine the influence of age, constitutional, lifestyle, and genetic factors on HAL. HAL was calculated from dual energy X-ray absorptiometry scans of the proximal femur using an automated technique with an Hologic QDR-1000W. Lean mass, fat mass, height, and weight were also measured. Maximum mean HAL was achieved by the age of 15 years. After this age there was no discernible dependency of mean HAL on age. Using within-pair differences, after adjusting for height there were no other independent constitutional or lifestyle predictors. Cross-sectionally, after adjustment for height, MZ and DZ correlations were 0.79 (95% CI: 0.73-0.84) and 0.54 (95% CI: 0.39-0.68), respectively, and independent of age. The MZ correlation exceeded the DZ correlation (p < 0.001). The best-fitting model apportioned 79% (SE 7%) of variation in height-adjusted HAL to additive genetic factors. There was marginal evidence that an environmental influence shared by twins explained 31% (SE 16%) of height-adjusted variance (p = 0.07), in which case the genetic variance was reduced to 51% (SE 15%). Adjustment for height had reduced the magnitude of total variance by 26%, and 95% of this reduction was in the additive genetic component. Applying a previously described theoretical model, approximately 10% of the increased risk of hip fracture associated with a maternal history of hip fracture could be attributed to the genetic factors determining HAL. We conclude that, in women, adult HAL is achieved by midadolescence. After adjustment for height, which is itself largely under genetic influence, other genetic factors appear to play the predominant role in explaining variation in HAL.

Does an early postnatal check-up improve maternal health: results from a randomised trial in Australian general practice

Objectives To investigate whether a visit to a general practitioner one week after discharge results in less depression, increased breastfeeding rates, improved patient wellbeing, fewer physical problems and greater satisfaction with general practice care than the traditional six week postnatal check‐up.

Effectiveness of general practice based, practice nurse led telephone coaching on glycaemic control of type 2 diabetes: the Patient Engagement And Coaching for Health (PEACH) pragmatic cluster randomised controlled trial

Objective To evaluate the effectiveness of goal focused telephone coaching by practice nurses in improving glycaemic control in patients with type 2 diabetes in Australia. Design Prospective, cluster randomised controlled trial, with general practices as the unit of randomisation. Setting General practices in Victoria, Australia. Participants 59 of 69 general practices that agreed to participate recruited sufficient patients and were randomised. Of 829 patients with type 2 diabetes (glycated haemoglobin (HbA1c) >7.5% in the past 12 months) who were assessed for eligibility, 473 (236 from 30 intervention practices and 237 from 29 control practices) agreed to participate. Intervention Practice nurses from intervention practices received two days of training in a telephone coaching programme, which aimed to deliver eight telephone and one face to face coaching episodes per patient. Main outcome measures The primary end point was mean absolute change in HbA1c between baseline and 18 months in the intervention group compared with the control group. Results The intervention and control patients were similar at baseline. None of the practices dropped out over the study period; however, patient attrition rates were 5% in each group (11/236 and 11/237 in the intervention and control group, respectively). The median number of coaching sessions received by the 236 intervention patients was 3 (interquartile range 1-5), of which 25% (58/236) did not receive any coaching sessions. At 18 months’ follow-up the effect on glycaemic control did not differ significantly (mean difference 0.02, 95% confidence interval −0.20 to 0.24, P=0.84) between the intervention and control groups, adjusted for HbA1c measured at baseline and the clustering. Other biochemical and clinical outcomes were similar in both groups. Conclusions A practice nurse led telephone coaching intervention implemented in the real world primary care setting produced comparable outcomes to usual primary care in Australia. The addition of a goal focused coaching role onto the ongoing generalist role of a practice nurse without prescribing rights was found to be ineffective. Trial registration Current Controlled Trials ISRCTN50662837.

Rites of passage: smoking and the construction of social identity

The following article, based on a qualitative study of young women from a Melbourne suburb, is concerned with the role smoking plays in the presentation of social identity. These women, in their early teens, are viewed as being in the liminal or transitional phase of a rite of passage to adulthood. The passage to adulthood is attained with the construction of a social identity corresponding to popular notions of the feminine, which fall into the familiar categories of the bad and good woman. Smoking is one of the props in the stereotypical representation of the bad woman. Conventional anti-smoking health messages have little relevance for young women who have chosen such a social identity for themselves.

Trials and tribulations of recruiting 2,000 older women onto a clinical trial investigating falls and fractures: Vital D study

BackgroundRandomised, placebo-controlled trials are needed to provide evidence demonstrating safe, effective interventions that reduce falls and fractures in the elderly. The quality of a clinical trial is dependent on successful recruitment of the target participant group. This paper documents the successes and failures of recruiting over 2,000 women aged at least 70 years and at higher risk of falls or fractures onto a placebo-controlled trial of six years duration. The characteristics of study participants at baseline are also described for this study.MethodsThe Vital D Study recruited older women identified at high risk of fracture through the use of an eligibility algorithm, adapted from identified risk factors for hip fracture. Participants were randomised to orally receive either 500,000 IU vitamin D3 (cholecalciferol) or placebo every autumn for five consecutive years. A variety of recruitment strategies were employed to attract potential participants.ResultsOf the 2,317 participants randomised onto the study, 74% (n = 1716/2317) were consented onto the study in the last five months of recruiting. This was largely due to the success of a targeted mail-out. Prior to this only 541 women were consented in the 18 months of recruiting. A total of 70% of all participants were recruited as a result of targeted mail-out. The response rate from the letters increased from 2 to 7% following revision of the material by a public relations company. Participant demographic or risk factor profile did not differ between those recruited by targeted mail-outs compared with other methods.ConclusionThe most successful recruitment strategy was the targeted mail-out and the response rate was no higher in the local region where the study had extensive exposure through other recruiting strategies. The strategies that were labour-intensive and did not result in successful recruitment include the activities directed towards the GP medical centres. Comprehensive recruitment programs employ overlapping strategies simultaneously with ongoing assessment of recruitment rates. In our experience, and others direct mail-outs work best although rights to privacy must be respected.Trial registrationISRCTN83409867 and ACTR12605000658617.

The prevalence and correlates of depression and anxiety in a sample of diabetic patients in Sharjah, United Arab Emirates.

BackgroundType 2 diabetes is very prevalent in the Gulf region, particularly in the United Arab Emirates (UAE) which has the second highest prevalence in the world. Factors contributing to this include changes in diet, adoption of sedentary lifestyles, and the consequent increase in rates of obesity. These changes are primarily due to rapid economic development and affluence. The aim of this study was to estimate the prevalence of psychological distress and its correlates in diabetic patients in the United Arab Emirates.MethodsPatients diagnosed with diabetes attending diabetes mini-clinics in the primary health care centres or hospitals of Sharjah were invited to participate in this cross-sectional study. Patients were interviewed using structured questionnaires to gather data on socio-demographics, lifestyle factors, diabetes complications, and medication usage. The K6 was administered as a screening tool for mental health concerns.ResultsThree hundred and forty-seven participants completed the interview. The majority of participants were females (65.4%) and the mean age was 53.2 (sd = 14.6). Approximately 12.5% of patients obtained a score of 19 or above (cut-off score) on the K6, indicating possible mental health concerns. Twenty-four percent had diabetes complications, mainly in the form of retinopathy, peripheral vascular disease and peripheral neuropathy. A significant relationship was found between scores on the K6, these complications of diabetes and the use of oral hypoglycemic and lipid lowering therapies.ConclusionsThe results of this study demonstrate a strong correlation between mental health status and diabetic complications. In particular, patients who are depressed tended to have poorer self-care, more severe physical symptoms and were less likely to adhere to prescribed care regimens. These findings raise the possibility that improving the mental health as part of a comprehensive management plan for diabetes may improve the overall long term outcomes of these patients.

Integration of primary health care services: perceptions of Australian general practitioners, non-general practitioner health service providers and consumers at the general practice-primary care interface

Abstract Introduction. In conjunction with GPs reporting on their own practice experiences, the experiences of non-GP health professionals and consumer representatives working at the primary care–general practice interface provide valuable considerations for exploring concepts for the development of a GP Integration Index relevant to Australian General Practice. Objectives. To identify concepts that GPs, non-GP health service providers and consumer representatives perceive to be important in facilitating a well integrated approach to delivering primary care, and how these are perceived to be occurring in practice. Method. Group discussions about GP integration were elicited using concept mapping with four groups of GPs and seven groups of health professionals and consumer representatives, purposively selected for diversity in demographic location and practice setting from three Australian States. From Victoria, 19 GPs from two different types of practice settings, 12 Consumer Representatives from 10 separate organisations, 17 Hospital Administrators from 16 major public and private hospitals, 18 specialist doctors representing 12 specialist organisations and 13 Community Service Providers. From Queensland, 13 rural GPs and 22 Nurses representing 10 separate nursing groups were selected. From Western Australia, 19 GPs representing a mix of solo practice, group practice and hospital settings, and 40 Allied Health providers representing various private practitioners and hospital and community centre based allied health practitioners. Concept mapping results from the groups were pooled and analysed using a descriptive meta-matrix to identify overarching themes. Results. Eight overarching themes were identified from consolidated concept maps: GP role; quality outcomes; practice management/accessibility; communication and networks; health care system politics; education and knowledge; personal attributes and attitudes; and lifestyle. Within these major themes, clusters of concepts rated as at least ‘important for patient care’ included various non-clinical aspects of primary care delivery. There was emphasis on a patient—centred and holistic care approach. Strongly advocated by all groups was the need for teamwork between GPs and other health care professionals involved in primary care of the patient. Conclusion. The use of concept mapping was successful in ensuring that the breadth of the topic was explored in its entirety among these groups, contributing to the identification of the dimensions of the concept of GP-integration. Findings from these groups will be pooled and subjected to structural equation modelling processes, to develop a general practice integration index relevant to the Australian setting.