Heart and Blood Diseases

All Conditions

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Symptoms and General Pathology

Coronary Artery Disease

Myocardial Ischemia

Coronary Disease

Heart Diseases

Diabetes Mellitus

Stroke

Body Weight

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

Low-risk lifestyle behaviours defined as:

1) Healthy body weight (Minimum: BMI \<30kg/m2 or WC of \<88 in females or \<92 in males); 2) Healthy diet (healthy diet, diet score with higher fruits \& vegetables to Mediterranean dietary pattern); 3) Regular physical activity (20 minutes ≥ 1 time/week ); 4) Smoking cessation (never smoked to smoking cessation \>12 months); 5) Moderate alcohol intake (up to 30g/day); 6) Adequate sleep (\>6 hours)

Low-risk lifestyle behaviours

JOHN L SIEVENPIPER, MD, PHD, FRCPC

Public health policy is universal in recommending the adoption of low risk low-risk lifestyle behaviors for health promotion and prevention of chronic or non-communicable diseases (NCDs).These behaviors generally include achieving and maintaining a healthy body weight, healthy diet, regular physical activity, smoking cessation, moderate alcohol intake, and adequate sleep. While there is a general consensus that adherence to any one of these low-risk lifestyle behaviors is associated with benefit, it is not clear if adherence to multiple behaviors would result in a larger benefit across different groups of people, conditions, and chronic disease outcomes. The Canadian Cardiovascular Society (CCS), as part of the Dyslipidemia Guidelines Update, commissioned a series of systematic reviews and meta-analyses (a type of knowledge synthesis) using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach to quantify the benefit of adherence to multiple low-risk lifestyle behaviors in relation to patient-important chronic disease outcomes (risk of cardiovascular disease, diabetes, cancer, and death) and assesses the quality and strength of the evidence for this benefit.

Rationale:

International health authorities universally recommend adherence to low-risk lifestyle behaviors for health promotion and prevention of chronic or non-communicable diseases (NCDs). Systematic reviews and meta-analyses of prospective cohort studies have shown that adherence to any one low-risk lifestyle behavior, including a healthy body weight, healthy diet, regular physical activity, smoking cessation, moderate alcohol intake, or adequate sleep, is associated with less risk of chronic disease. Although individual prospective cohort studies have shown that adherence to a combination of these low-risk lifestyle behaviors is associated with an even greater benefit, there are no systematic reviews and meta-analyses assessing whether it holds across different definitions of low-risk lifestyle behaviors, levels of exposure, populations, geographical regions, background risks, and chronic disease outcomes. To inform recommendations for the role of low-risk lifestyle behaviors in chronic disease prevention, the Canadian Cardiovascular Society (CCS), as part of the Dyslipidemia Guidelines Update, commissioned a series of systematic reviews and meta-analyses using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach of the association between adherence to a combination of low-risk lifestyle behaviors and (1) cardiovascular disease (CVD), (2) diabetes, (3) cancer, and (4) all-cause mortality outcomes.

Objectives:

1. To conduct a series of systematic reviews and meta-analyses of the association between adherene to a combination of low-risk lifestyle behaviors and 4 chronic disease outcomes (1) cardiovascular disease (cardiovascular disease (CVD) incidence and mortality, coronary heart disease \[CHD\] incidence and mortality, and stroke incidence and mortality), (2) diabetes, (3) cancer (cancer incidence and cancer mortality), and (4) all-cause mortality.
2. To assess the quality and strength of the evidence using GRADE.

Design:

The planning and conduct of the proposed systematic reviews and meta-analyses will follow the Cochrane handbook for systematic reviews of interventions. The reporting will follow the Meta-Analysis Of Observational Studies in Epidemiology (MOOSE) and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statements.

Data sources:

MEDLINE, EMBASE, and The Cochrane Central Register of Controlled Trials (Clinical Trials; CENTRAL) will be searched using appropriate search terms. These searches will be supplemented by manual hand searches of the bibliographies of included studies and existing review articles.

Study selection:

Prospective cohort studies investigating the relation of at-least three low-risk lifestyle behaviors, one of which must include a healthy diet, with incident cardiovascular disease, diabetes, cancer or all-cause mortality will be included. Studies will be excluded if low-risk lifestyle behaviors are combined with biomarkers.

Data extraction:

Two independent reviewers or more will independently extract relevant information about study design, sample size, subject characteristics, low risk lifestyle behaviors, duration/person-years of follow-up, adjustments of models. Risk ratios for clinical outcomes will be extracted or derived from clinical event data across quantiles of exposure.

Risk of bias:

Two independent reviewers or more will assess risk of bias of (ROB) of each of the included prospective cohort studies using the Newcastle-Ottawa Scale (NOS) by . Up to 9 points can be awarded based on cohort selection (max 4 points), the comparability of cohort design and analysis (max 4 points), and adequacy of the outcome measures (max 3 points). Studies that receive ≥6 points will be considered as higher quality.

Outcomes:

Each of the four proposed systematic reviews and meta-analyses will assess a different chronic disease outcome: cardiovascular disease (CVD incidence and mortality, CHD incidence and mortality, and stroke incidence and mortality), (2) diabetes, (3) cancer (cancer and cancer mortality), and (4) all-cause mortality.

Data synthesis:

Risk estimates of extreme comparisons (all who adhered to low-risk behaviors versus none) will be pooled using inverse variance random effects models and expressed as risk ratios (RR) with 95% confidence intervals (CIs). Between-cohort heterogeneity will be assessed by the Cochran Q (chi-square) statistic and quantified by the I2 statistic. The significance level will be set at p\<0.10 and an I2 ≥ 50% will be considered evidence of substantial heterogeneity. To explore sources of heterogeneity, the investigators will conduct sensitivity analyses, in which each study is systematically removed with recalculation of the summary estimates. If there are \>=10 studies, then the investigators will also explore sources of heterogeneity using a priori subgroup analyses by underlying disease status, sex, number of lifestyle factors, follow-up (\<10 years, ≥10 years), level of adjustment of models, NOS, ascertainment of outcome, and individual domains of NOS Meta-regression analyses will assess the significance of categorical and continuous subgroups analyses. Dose-response analyses will be undertaken using random-effects generalized least squares trend estimation models (GLST) to assess linear relationships and spline curve modeling (the MKSPLINE procedure) to assess non-linear relationships. If ≥10 cohort comparisons are available, then publication bias will be assessed by visual inspection of funnel plots and formally tested with the Egger and Begg tests at a significance level of p≤ 0.10. If publication bias is suspected, then the investigators will attempt to adjust for funnel plot asymmetry by imputing the missing study data using the Duval and Tweedie trim and fill method.

Quality of evidence:

Evidence profiles will be produced the overall strength and quality of the evidence will be assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) system. This system grades the evidence as "high quality", "moderate quality", "low quality", or "very low quality". The included prospective cohort studies will start at "low quality" by default and then be downgraded or upgraded based on pre-specified criteria. Criteria to downgrade will include study limitations (weight of studies show risk of bias by NOS), inconsistency (substantial unexplained inter-study heterogeneity, I2\>50% and P\<0.10), indirectness (presence of factors relating to the population, exposures, and outcomes that limit generalizability), imprecision (95% CI are wide or cross a minimally important difference of 10% \[RR 0.9- 1.1\]), and publication bias (significant evidence of small-study effects). Criteria to upgrade will include a large magnitude effect (RR\>2 or RR\<0.5 in the absence of plausible confounders), a dose-response gradient, and attenuation by plausible confounding effects.

Knowledge translation plan:

The results will be disseminated through interactive presentations at local, national, and international scientific meetings and publication in high impact factor journals. Target audiences will include the public health and scientific communities with interest in nutrition, physical activity, lifestyle modification, diabetes, cancer and cardiovascular disease. Feedback will be incorporated and used to improve the public health message and key areas for future research will be defined.

Significance:

The proposed project will aid in knowledge translation related to the effects of low-risk lifestyle behaviours on cardiovascular disease, diabetes, cancer, and all-cause mortality, strengthening the evidence-base for recommendations and improving health outcomes through informing consumers and public health policy makers, stimulating industry innovation, and guiding future research.

Role of the funding sources:

The funding source will have no role in the research question, design, analysis, results and interpretation of the results of this study.

Meta-Analyses of Low-risk Lifestyle Behaviours and Patient Important Outcomes

Relation of Low-risk Lifestyle Behaviours With Cardiovascular Disease, Diabetes, Cancer and All-Cause Mortality: A Series of Systematic Reviews and Meta-analyses of Prospective Cohort Studies

Cardiovascular disease incidence and mortality, coronary heart disease incidence and mortality, stroke incidence and mortality

Canadian Institutes of Health Research (CIHR)

The Physicians' Services Incorporated Foundation

Canadian Diabetes Association

Canadian Cardiovascular Society

Banting & Best Diabetes Centre

University of Toronto

Associate Professor

Neoplasms

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

medical decision based on computerized guideline-based decision support system

Introduction of a computer-based decision support system in the medical decision process

ONCODOC LOGICIEL

Serge UZAN, MD, PhD

The objective of the study is to evaluate how the use of OncoDoc2, a computerized guideline-based decision support system, could improve the compliance of multidisciplinary staff meeting decisions with local clinical practice guidelines in the management of non-metastatic breast cancer.

In France, to promote the quality of cancer care, decisions have currently to be made according to clinical practice guidelines (CPGs) during regularly organized multidisciplinary staff meetings (MSMs). Dissemination of textual CPGs has a poor impact on clinical practice as opposed to the use of clinical decision support systems (CDSSs) known to improve compliance with CPGs. OncoDoc2 is a CDSS providing patient-specific recommendations based on CPGs for non-metastatic female breast cancer management elaborated by the CancerEst INTERMEDICAL collaboration.The main goal of the study is to evaluate the effect of the routine use of OncoDoc2 during MSMs on compliance of MSM decisions with local CPGs. Impact will be measured by the compliance rate of MSM decisions with OncoDoc2 recommendations. The design of the study relies on a cluster randomized controlled trial. Under the assumption of a baseline compliance rate of 70% without intervention, an expected compliance rate of 90% in the intervention group (α = 5%, β = 20%), an inter-cluster variability of 5%, and 59 decisions per center, the required number of centers is 3 in each group, or 177 decisions in each arm. The study will be conducted in cancer care centers (public and private) from Paris area, France.This prospective trial will be conducted in two steps. First, baseline compliance rates will be measured in each center. Then, the 6 centers will be randomized into 2 arms. In the intervention arm, OncoDoc2 will be used during MSMs at decision time. Every case of non-adherence with system recommendations will have to be justified by clinicians. In both arms and after each MSM, MSM decisions will be recorded as well as patient characteristics and OncoDoc2 will be used for each patient case to get system recommendations. In the intervention arm, OncoDoc2 recommendations obtained by MSM will also be recorded, as well as the reason for non following recommendations in case MSM decision does not comply with guidelines.

Impact of OncoDoc2 on Guideline Compliance in the Management of Breast Cancer

Impact of the OncoDoc2 Decision Support System on Compliance of Multidisciplinary Staff Meeting Decisions With Clinical Practice Guidelines in the Management of Non-metastatic Breast Cancer.

Assistance Publique - Hôpitaux de Paris

Blood and Lymph Conditions

Immune System Diseases

Infections

Rare Diseases

Recurrence

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Lymphoma, B-Cell

Burkitt Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Lymphoma, Non-Hodgkin

Communicable Diseases

Epstein-Barr Virus Infections

Virus Diseases

Herpesviridae Infections

DNA Virus Infections

Tumor Virus Infections

Myeloid Leukemia

Acute Myeloid Leukemia

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Non Lymphoblastic Leukemia

B-cell Lymphoma

Acute Graft Versus Host Disease

Childhood Acute Lymphoblastic Leukemia

AIM 1 (CHART REVIEW): Patients are separated for each CPG evaluated (fever and neutropenia \[FN\], chemotherapy induced nausea and vomiting \[CINV\], fertility preservation \[FP\]) and are randomly selected for medical chart review. Patients with eligible episodes of FN, CINV or FP within the health records are selected and have the data from their records abstracted and reviewed by COG for adherence to COG endorsed CPGs.

AIM 2 (FOCUS GROUPS): Health care providers who provide direct care to pediatric oncology patients are identified and separated to participate in three types of focus groups: physician-only, non-physician, and mixed.

AIM 3 (INTERVIEWS): Health care providers undergo one-on-one interviews consisting of think aloud technique (TAL) of cognitive interviewing.

Informational Intervention

Interview

Medical Chart Review

Questionnaire Administration

L. Lee Dupuis

This research trial studies the use of clinical practice guidelines by pediatric oncology healthcare providers in order to identify, understand, and overcome barriers to them. The treatments for childhood cancers are intense and result in a high rate of symptoms which require support by healthcare providers. By reviewing patients' medical chart records, meeting in focus groups and in one-on-one interviews, healthcare providers may improve how clinical practice guidelines are used to support children undergoing cancer treatment.

PRIMARY OBJECTIVES:

I. To measure the rate of adherence to selected Children's Oncology Group (COG)-endorsed supportive care clinical practice guidelines (CPG) recommendations at National Cancer Institute (NCI) Community Oncology Research Program (NCORP) sites. (Aim 1) II. To describe the possible influence of NCORP site size and the number of patients enrolled in COG studies per site on the delivery of CPG-consistent care. (Aim 1a) III. To describe the clinical outcome of episodes during which patients receive CPG-consistent or CPG-inconsistent care. (Aim 1b) IV. To describe facilitators of and barriers to the use of CPGs elicited via focus group interviews with a diverse set of potential users (physician, nurse, nurse practitioner and pharmacists) who provide pediatric cancer care at NCORP sites. (Aim 2) V. To improve how well CPG recommendations are understood by health care providers by refining the CPG recommendation format based on an iterative process of cognitive interviewing and formatting revisions. (Aim 3)

OUTLINE:

AIM 1 (CHART REVIEW): Patients are separated for each CPG evaluated (fever and neutropenia \[FN\], chemotherapy induced nausea and vomiting \[CINV\], fertility preservation \[FP\]) and are randomly selected for medical chart review. Patients with eligible episodes of FN, CINV or FP within the health records are selected and have the data from their records abstracted and reviewed by COG for adherence to COG endorsed CPGs.

AIM 2 (FOCUS GROUPS): Health care providers who provide direct care to pediatric oncology patients are identified and separated to participate in three types of focus groups: physician-only, non-physician, and mixed.

AIM 3 (INTERVIEWS): Health care providers undergo one-on-one interviews consisting of think aloud technique (TAL) of cognitive interviewing.

Identifying, Understanding, and Overcoming Barriers to the Use of Clinical Practice Guidelines in Pediatric Oncology

Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric Oncology

FN will be identified by chart review. Outcome variable will be the binary endpoint of CPG-consistent versus (vs.) CPG inconsistent care for each FN episode.

CINV will be identified by chart review. Outcome variable will be the binary endpoint of CPG-consistent vs. CPG inconsistent care for each CINV episode (separately for high and moderate emetogenicity risk chemotherapy).

FP will be identified by chart review. Outcome variable will be the binary endpoint of CPG-consistent vs. CPG inconsistent care for each FP episode.

Will be estimated and examined as fixed effect covariates in these generalized linear mixed effect models described above.

Will be identified by the Framework for Clinical Practice Guideline Implementability. Operational definitions of each category will be determined. The implementation barriers and facilitators identified by focus group members will be coded using these categories independently by two investigators. New categories and sub-categories will be used to code concepts that do not fall within the pre-determined categories. Themes of commonality will be sought especially within the newly developed categories that fall outside the framework adapted from Gagliardi et al. Facilitators of and barriers to CPG implementation will be described.

The issues identified via the interviews, changes made to the formatting, and rationale for the changes will be documented between each round in a tracking matrix. The proportion of interviewees who select the correct course of action when presented with four possible courses of action will be described for each iteration of the CPG format including the final version. Understanding is defined as the correct interpretation of the course of action recommended or suggested by a CPG.

National Cancer Institute (NCI)

Children's Oncology Group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Meta-Analyses of Low-risk Lifestyle Behaviours and Patient Important Outcomes	NCT03234101	Cardiovascular ... Diabetes Cancer Mortality	Low-risk lifest...	-	University of Toronto
Impact of OncoDoc2 on Guideline Compliance in the Management of Breast Cancer	NCT00728442	Breast Cancer	ONCODOC LOGICIE...	-	Assistance Publique - Hôpitaux de Paris
Identifying, Understanding, and Overcoming Barriers to the Use of Clinical Practice Guidelines in Pediatric Oncology	NCT02847130	Acute Lymphobla... B-Cell Non-Hodg... Childhood Acute... Childhood Burki... Childhood Neopl... Hematopoietic a... Malignant Solid... Recurrent Child...	Informational I... Interview Medical Chart R... Questionnaire A...	- 20 Years	Children's Oncology Group
Meta-Analyses of Low-risk Lifestyle Behaviours and Patient Important Outcomes	NCT03234101	Cardiovascular ... Diabetes Cancer Mortality	Low-risk lifest...	-	University of Toronto
Impact of OncoDoc2 on Guideline Compliance in the Management of Breast Cancer	NCT00728442	Breast Cancer	ONCODOC LOGICIE...	-	Assistance Publique - Hôpitaux de Paris
Meta-Analyses of Low-risk Lifestyle Behaviours and Patient Important Outcomes	NCT03234101	Cardiovascular ... Diabetes Cancer Mortality	Low-risk lifest...	-	University of Toronto

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