Feasibility of identifying important changes in care management resulting from cardiovascular magnetic resonance (CMR) using hospital episode data in patients who activate the primary percutaneous coronary intervention (PPCI) pathway.

BACKGROUND: We determined whether it is feasible to identify important changes in care management resulting from cardiovascular magnetic resonance (CMR) in patients who activate the primary percutaneous coronary intervention (PPCI) pathway from hospital episode data, in order to construct a composite primary outcome (hypothesised to reduce the risk of major adverse cardiac-related events, MACE) to compare patients exposed to CMR or not. METHODS: We used Hospital Episode Statistics (HES) and Patient Episode Database for Wales (PEDW) to identify clinical events that reflected important changes in management in the year following the index admission in five subgroups of patients who activated the PPCI pathway recruited as part of a feasibility cohort study (n = 1655 with HES/PEDW data). For all subgroups, we identified frequency of events and time to the first event for each change in management. RESULTS: We identified all clinical events (new diagnoses, additional diagnostic tests and procedures) except for medication prescriptions. Diagnostic tests were underestimated because most are carried out in outpatient clinics and outpatient datasets had missing procedure codes for 74% of patients (some tests done in hospital may also not be recorded). We successfully tabulated frequencies of events and distributions of times to first event for most changes in management by CMR status and in CMR / non CMR centres. CONCLUSIONS: It is feasible to identify changes in care management between patients who have / do not have CMR within relevant patient subgroups. Further work to derive a weighting algorithm is required before attempting to combine the events in a composite endpoint.

Correction to: Feasibility of identifying important changes in care management resulting from cardiovascular magnetic resonance (CMR) using hospital episode data in patients who activate the primary percutaneous coronary intervention (PPCI) pathway.

In the original publication of this article [1], the author noted two corrections after publication.

High-resolution peripheral quantitative computed tomography and finite element analysis of bone strength at the distal radius in ovariectomized adult rhesus monkey demonstrate efficacy of odanacatib and differentiation from alendronate.

Translational evaluation of disease progression and treatment response is critical to the development of therapies for osteoporosis. In this study, longitudinal in-vivo monitoring of odanacatib (ODN) treatment efficacy was compared to alendronate (ALN) in ovariectomized (OVX) non-human primates (NHPs) using high-resolution peripheral computed tomography (HR-pQCT). Treatment effects were evaluated using several determinants of bone strength, density and quality, including volumetric bone mineral density (vBMD), three-dimensional structure, finite element analysis (FEA) estimated peak force and biomechanical properties at the ultradistal (UD) radius at baseline, 3, 6, 9, 12, and 18 months of dosing in three treatment groups: vehicle (VEH), low ODN (2 mg/kg/day, L-ODN), and ALN (30 µg/kg/week). Biomechanical axial compression tests were performed at the end of the study. Bone strength estimates using FEA were validated by ex-vivo mechanical compression testing experiments. After 18months of dosing, L-ODN demonstrated significant increases from baseline in integral vBMD (13.5%), cortical thickness (24.4%), total bone volume fraction BV/TV (13.5%), FEA-estimated peak force (26.6%) and peak stress (17.1%), respectively. Increases from baseline for L-ODN at 18 months were significantly higher than that for ALN in DXA-based aBMD (7.6%), cortical thickness (22.9%), integral vBMD (12.2%), total BV/TV (10.1%), FEA peak force (17.7%) and FEA peak stress (11.5%), respectively. These results demonstrate a superior efficacy of ODN treatment compared to ALN at the UD radii in ovariectomized NHPs.

Effect of odanacatib on bone turnover markers, bone density and geometry of the spine and hip of ovariectomized monkeys: a head-to-head comparison with alendronate.

Odanacatib (ODN) is a selective and reversible Cathepsin K (CatK) inhibitor currently being developed as a once weekly treatment for osteoporosis. Here, effects of ODN compared to alendronate (ALN) on bone turnover, DXA-based areal bone mineral density (aBMD), QCT-based volumetric BMD (vBMD) and geometric parameters were studied in ovariectomized (OVX) rhesus monkeys. Treatment was initiated 10 days after ovariectomy and continued for 20 months. The study consisted of four groups: L-ODN (2 mg/kg, daily p.o.), H-ODN (8/4 mg/kg daily p.o.), ALN (15 µg/kg, twice weekly, s.c.), and VEH (vehicle, daily, p.o.). L-ODN and ALN doses were selected to approximate the clinical exposures of the ODN 50-mg and ALN 70-mg once-weekly, respectively. L-ODN and ALN effectively reduced bone resorption markers uNTx and sCTx compared to VEH. There was no additional efficacy with these markers achieved with H-ODN. Conversely, ODN displayed inversely dose-dependent reduction of bone formation markers, sP1NP and sBSAP, and L-ODN reduced formation to a lesser degree than ALN. At month 18 post-OVX, L-ODN showed robust increases in lumbar spine aBMD (11.4%, p<0.001), spine trabecular vBMD (13.7%, p<0.001), femoral neck (FN) integral (int) vBMD (9.0%, p<0.001) and sub-trochanteric proximal femur (SubTrPF) int vBMD, (6.4%, p<0.001) compared to baseline. L-ODN significantly increased FN cortical thickness (Ct.Th) and cortical bone mineral content (Ct.BMC) by 22.5% (p<0.001) and 21.8% (p<0.001), respectively, and SubTrPF Ct.Th and Ct.BMC by 10.9% (p<0.001) and 11.3% (p<0.001) respectively. Compared to ALN, L-ODN significantly increased FN Ct. BMC by 8.7% (p<0.05), and SubTrPF Ct.Th by 7.6% (p<0.05) and Ct.BMC by 6.2% (p<0.05). H-ODN showed no additional efficacy compared to L-ODN in OVX-monkeys in prevention mode. Taken together, the results from this study have demonstrated that administration of ODN at levels which approximate clinical exposure in OVX-monkeys had comparable efficacy to ALN in DXA-based aBMD and QCT-based vBMD. However, FN cortical mineral content clearly demonstrated superior efficacy of ODN versus ALN in this model of estrogen-deficient non-human primates.

Effectiveness of a regional self-study perinatal education programme: a successful adaptation in Yucatan, Mexico.

OBJECTIVE: To evaluate the effectiveness of the Perinatal Continuing Education Programme (PCEP) in a Latin American country. METHODS: We carried out a study within secondary and tertiary care, and rural Mexican Institute of Social Security (IMSS) hospitals on the Yucatan Peninsula. Participants were doctors, nurses and nursing assistants working with pregnant women and newborns at each hospital. The PCEP was translated into Spanish and then implemented between January 1998 and December 2001. Two nurses at each hospital were trained to co-ordinate the programme and the personnel were invited to participate. Participation involved purchasing the self-teaching books, study outside work hours and participation in skills demonstration and practice sessions. Evaluation included the percentage of personnel who participated in and those who completed the programme, an opinion survey of the programme, level of pre- and post-intervention knowledge, and the quality of neonatal care according to expert-recommended routines. Results were analysed with chi-square and Student's t-tests. RESULTS: A total of 65.3% of the 1421 people in the study population began the programme and 72% of those completed it. Improvement was observed in 14 of 23 (P<0.05) evaluated neonatal care practices. Participants rated the written material as very clear and useful in daily practice. CONCLUSIONS: The PCEP is an effective strategy for improving the level of knowledge and perinatal care in all regional hospitals on the Yucatan Peninsula, Mexico. This initial application of the PCEP in a Spanish-speaking country was successful.

Regionalized perinatal education.

Despite changes in the organization and financing of healthcare delivery, and dramatic increases in the number and distribution of perinatal facilities and professionals over the past three decades, there remains a continuing need for effective and efficient regionalized perinatal outreach education programmes. Both the organizers and the participants should be multidisciplinary and include both inpatient and outpatient providers. Content should be restricted to issues relevant to participants' practice, and include topics ranging from preconception to postpartum and early infant care. There are various effective formats, but consideration should be given to reaching as many providers as possible simultaneously within a given facility, minimizing expense and economizing on participants' time. Evaluation strategies range from assessment of immediate outcomes, which generally examine programme process, to ultimate outcomes, which measure changes in patient care and patient health.