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Association between long-term use of calcium channel blockers (CCB) and the risk of breast cancer: a retrospective longitudinal observational study protocol

Por: Ho · C. · Ha · N. T. · Youens · D. · Abhayaratna · W. P. · Bulsara · M. K. · Hughes · J. D. · Mishra · G. · Pearson · S.-A. · Preen · D. B. · Reid · C. M. · Ruiter · R. · Saunders · C. M. · Stricker · B. H. · van Rooij · F. J. A. · Wright · C. · Moorin · R.
Introduction

Calcium channel blockers (CCB), a commonly prescribed antihypertensive (AHT) medicine, may be associated with increased risk of breast cancer. The proposed study aims to examine whether long-term CCB use is associated with the development of breast cancer and to characterise the dose–response nature of any identified association, to inform future hypertension management.

Methods and analysis

The study will use data from 2 of Australia’s largest cohort studies; the Australian Longitudinal Study on Women’s Health, and the 45 and Up Study, combined with the Rotterdam Study. Eligible women will be those with diagnosed hypertension, no history of breast cancer and no prior CCB use at start of follow-up (2004–2009). Cumulative dose-duration exposure to CCB and other AHT medicines will be captured at the earliest date of: the outcome (a diagnosis of invasive breast cancer); a competing risk event (eg, bilateral mastectomy without a diagnosis of breast cancer, death prior to any diagnosis of breast cancer) or end of follow-up (censoring event). Fine and Gray competing risks regression will be used to assess the association between CCB use and development of breast cancer using a generalised propensity score to adjust for baseline covariates. Time-varying covariates related to interaction with health services will also be included in the model. Data will be harmonised across cohorts to achieve identical protocols and a two-step random effects individual patient-level meta-analysis will be used.

Ethics and dissemination

Ethical approval was obtained from the following Human research Ethics Committees: Curtin University (ref No. HRE2022-0335), NSW Population and Health Services Research Ethics Committee (2022/ETH01392/2022.31), ACT Research Ethics and Governance Office approval under National Mutual Acceptance for multijurisdictional data linkage research (2022.STE.00208). Results of the proposed study will be published in high-impact journals and presented at key scientific meetings.

Trial registration number

NCT05972785.

Very brief intervention for physical activity behaviour change in cardiac rehabilitation: protocol for the 'Measure It! effectiveness-implementation hybrid trial

Por: Freene · N. · McPhail · S. M. · Tyack · Z. · Kunstler · B. · Niyonsenga · T. · Keegan · R. · Gallagher · R. · Abhayaratna · W. · Verdicchio · C. · Davey · R.
Introduction

Physical inactivity is a risk factor for repeat cardiac events and all-cause mortality in coronary heart disease (CHD). Cardiac rehabilitation, a secondary prevention programme, aims to increase physical activity levels in this population from a reported low baseline. This trial will investigate the effectiveness and implementation of a very brief physical activity intervention, comparing different frequencies of physical activity measurement by cardiac rehabilitation clinicians. The Measure It! intervention (

Methods and analysis

This type 1 hybrid effectiveness–implementation study will use a two-arm multicentre assessor-blind randomised trial design. Insufficiently active (

Ethics and dissemination

The study has ethical approval (University of Canberra (ID 11836), Calvary Bruce Public Hospital (ID 14-2022) and the Greater Western Area (ID 2022/ETH01381) Human Research Ethics Committees). Results will be disseminated in multiple formats for consumer, public and clinical audiences.

Trial registration number

ACTRN12622001187730p.

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