Research: Pilot Projects

Pilot Projects Year 3 (2006-2007)

These projects will help young investigators to establish bases to apply for bigger grants


Development and validation of efficient methods for testing gender and/or sex differences in the effects of cardiovascular risk factors and responses to treatment

Dr. Michal Abrahamowicz
McGill University Health
Center and McGill University
687, av. des Pins Ouest, A4.20.A
Montreal (QC)
H3A 1A1

Dr. Pavel Hamet
Dr. Erick Loucks
Dr. Louise Pilote
Dr. Cara Tannenbaum

The overall objective of this 1-year project is to develop and validate efficient and accurate statistical methodology for testing Gender/Sex interaction with multiple, complex, possibly time-dependent and/or multi-dimensional exposures, on which the future CIHR application will partly rely. We expect that the background information and simulation results generated by this Genesis Theme Project will then serve as ‘pilot data’, and will help in enhancing both the relevance and the methodology of the future CIHR grant application. In particular, the following Specific Objectives will be addressed in the 1-year Genesis Theme project:

  1. Review epidemiological literature on Gender differences in CVD outcomes and responses to treatment, in order to (1a) identify empirical findings regarding Gender interactions with CVD risk factors or interventions, and (1b) assess the methodology used in these studies.
  2. Review statistical literature to identify novel methods that may help increasing accuracy and/or efficiency of testing complex, time-dependent, non-linear, and/or multi-dimensional interactions.
  3. Carry out analytical work to design new, more comprehensive and more efficient statistical methods to efficiently identify such complex interactions, accurately test their statistical significance, and precisely estimate their strength.
  4. Design, program and perform a comprehensive simulation study, with the following specific goals:
  5. (4a) demonstrate bias, inflation of type I error (‘false discovery rate’), and/or low power of some conventional methods, used in the literature, to assess the interactions with Gender or Sex, that fail to accurately account for the complexities discussed above;
  6. (4b) validate the new methods, developed in 3/ above, with respect to accuracy of type I error, point estimates and confidence intervals, across a range of clinically plausible simulated scenarios, of various complexity;
  7. (4c) assess the ability of model fit statistical criteria to identify which of inter-related components of exposure or treatment history “drives” the interaction, i.e. has differential effects in men vs. women;
  8. (4d) compare different methods, including those identified in the statistical literature e.g. 3,4 and those developed by our team (see, respectively, 2/ and 3/ above) with respect to accuracy and precision of the estimated interactions, and statistical power of interaction testing;
  9. (4e) develop numerical ‘power/sample size tables’ to help in planning future, adequately powered studies to test interactions involving Gender or Sex.
  10. To identify the number of salivary cortisol samples needed to reliably measure the awakening cortisol response (i.e., a physiological marker of stress) in boys and girls.


Antihypertensive Drug Use Among Elderly Stroke Survivors: Differences In Sex/Gender

Dr. Nadia Khan
Center for Health Evaluation
and Outcome Sciences,
1081 Burrard Street, 620-B
Vancouver (British Columbia)
V6Z 1Y6
Dr. Moira Kapral
Dr. Karin Humphries

For this study, there are 3 main objectives:

  1. Determine the proportion of elderly women and men stroke survivors prescribed antihypertensive drug therapy within 6 months of stroke. What proportion of these patients, were prescribed ACE inhibitor and/or thiazide diuretics?
  2. Measure the persistency to these antihypertensive agents by sex/gender.
  3. Determine the independent association of antihypertensive drug use on the combined endpoint of stroke, acute MI or death at 1- year post stroke among elderly women and men..

Given the disparities seen in administration of antiplatelet agents after stroke across gender/sex, we hypothesize that women will less often receive antihypertensive medications after stroke and specifically, less often receive ACE inhibitor and/or thiazide diuretic after stroke. We also hypothesize that persistence to antihypertensive agents will be low among both men and women and that antihypertensive use will be independently associated with reduced cardiovascular endpoints.


Women’s Adherence to Cardiac Rehabilitation by Program Model: A Pilot Randomized Controlled Trial

Dr. Sherry Grace
York University,
368 Bethune,
4700 Keele St,
Toronto (Ontario)
M3J 1P3
Rosemarie Macchi
Beth Abramson
Len Sternberg
Kenneth Melvin
Louise Pilote

The primary objective of this study is to compare women’s program and exercise adherence across 3 CR program models, to determine which program model results in the greatest adherence. .

The secondary objectives of this study are to:

  1. compare cardiac risk reduction and psychosocial outcomes by CR program model
  2. query participants as to their preferred CR program if given a choice. Risk factors will include blood pressure, lipids, waist circumference, smoking status, medication adherence, and nutrition. Psychosocial outcomes will include depression, stress, and social support

Women randomized to the women-only and home-based CR programs will demonstrate significantly greater program and exercise adherence than women in the traditional CR and usual care groups.


WREST-E: An Extension Substudy of the Women’s Recovery from Sternotomy (WREST) Study>

Dr. Kathryn King
Centre for Health and Policy StudiesDepartment
of Community Health Sciences
3330 Hospital Drive NW
Calgary, Alberta,
T2N 4N1
Ross Tsuyuki
Monica Parry
Ruth Collins-Nakai
Andrew Maitland
Peter Faris
Gillian Currie

We aim to:

  1. describe the longer term outcomes (e.g., primary outcomes of the WREST Trial)---pain, discomfort, functional status; secondary outcomes--wound healing, health-related quality of life, health services use) of women following sternotomy;
  2. examine the extent to which postoperative pain, discomfort, functional status, health-related quality of life, health services use in the early recovery from sternotomy period (5 days and 12-weeks) predicts outcomes in these same variables at the 12th postoperative month;
  3. determine if there are between group differences (intervention or usual care) in outcomes associated with the original WREST Trial that that extend to the 12th postoperative month.

Women randomized to the women-only and home-based CR programs will demonstrate significantly greater program and exercise adherence than women in the traditional CR and usual care groups.