Conflicts of Interest and the Quality of Recommendations in Clinical Guidelines

Background: There is increasing concern that conflicts of interest affect the development process of clinical practice guidelines. We evaluated The American Psychiatric Association\u27s Practice Guideline for the Treatment of Patients with Major Depressive Disorder to determine the existence of financial and intellectual conflicts of interest and examine their possible effects. We selected this guideline because of its influence on clinical practice and because this guideline recommends pharmacotherapy for all levels of depression, despite controversies over the evidence base. Methods and Findings: We determined the number and type of financial conflicts of interest for members of the guideline development group as well as for the independent panel charged with mitigating any effect of these conflicts. We also quantified the potential for intellectual conflicts of interest. We examined the quality of references used to support recommendations, as well as the degree of congruence between the research results and the recommendations. Fewer than half (44.4%) of the studies supporting the recommendations met criteria for high quality. Over one-third (34.2%) of the cited research did not study outpatients with major depressive disorder, and 17.2% did not measure clinically relevant results. One-fifth (19.7%) of the references were not congruent with the recommendations. Financial ties to industry were disclosed by all members (100%) of the guideline development committee with members reporting a mean 20.5 relationships (range 9–33). The majority of the committee participated on pharmaceutical companies\u27 speakers\u27 bureaus. Members of the independent panel that reviewed the guidelines for bias had undeclared financial relationships. As a marker of intellectual conflict of interest, 9.1% of all cited research and 13% of references supporting the recommendations were co-authored by the six guideline developers. Conclusions: The prevalence of conflicts of interest among panel members was high. The quality of the evidence cited raises questions about the validity of the recommendations. Attention to the quality of cited studies and to the risk of bias resulting from conflicts of interest should be a priority for guideline development groups

Behavior change communication model enhancing parental practices for improved early childhood growth and development outcomes in rural Armenia – A quasi-experimental study

The latest evidence demonstrates the importance of nurturing care from conception to lay a strong foundation for children's cognitive, socio-emotional and physical well-being. The interventions enhancing parental practices in children's health and growth, protection from neglect, abuse, and injury have lifelong impact on health, learning, economic productiveness outcomes. Existing maternal and child health delivery platforms might potentially be utilized to integrate Early Childhood Development interventions. However, there is a dearth of studies demonstrating the feasibility and effectiveness of an integrated MCH and ECD model. ECD component was integrated into MCH program activities, implemented and tested in Armenia. For 14 months, all mothers of children aged 0 to 23 months (1300) living in 43 communities in Gegharkunik province (Armenia) participated in the study. Twenty-three intervention communities (680 children) received added ECD package to MCH intervention, and 20 control communities (630 children) received only MCH intervention. We used a quasi-experimental intervention-control design, with pre-and post-data collected. Variables measured and compared were related to child development, nutrition status, parental child care (stimulation, discipline) and nutrition practices.Intervention sites showed 83% higher odd of total ECD composite score (cognitive, language, motor) compared to children in the control sites. Child caregivers had better child care, nutrition practices and early learning support than controls. No change was found in discipline practices and stunting rates. MCH-ECD integrated model is an effective delivery platform for improving parenting behavior, child growth, and development. Keywords: Behavior change, Parental practices, Early childhood development, Quasi-experimental stud

Evidence-informed health policy - the crucial role of advocacy

Health policy makers and clinicians often face similar decision-making challenges. The issues are turbulent, characterised by high risk and complexity, often involve value conflicts and occur in settings of rapid change. Policy makers\u27 decisions are under increasing scrutiny for their use of evidence, with many health policies reflecting political influence rather than rigorous analysis. The evidence-based policy movement offers a range of accounts for this. We argue that advocacy in three critical areas helps explain when evidence is used in the policy making process and then contrast the impacts of advocacy for evidence use in two nutrition policy cases

Support of personalized medicine through risk-stratified treatment recommendations - an environmental scan of clinical practice guidelines

BACKGROUND: Risk-stratified treatment recommendations facilitate treatment decision-making that balances patient-specific risks and preferences. It is unclear if and how such recommendations are developed in clinical practice guidelines (CPGs). Our aim was to assess if and how CPGs develop risk-stratified treatment recommendations for the prevention or treatment of common chronic diseases. METHODS: We searched the United States National Guideline Clearinghouse for US, Canadian and National Institute for Health and Clinical Excellence (United Kingdom) CPGs for heart disease, stroke, cancer, chronic obstructive pulmonary disease and diabetes that make risk-stratified treatment recommendations. We included only those CPGs that made risk-stratified treatment recommendations based on risk assessment tools. Two reviewers independently identified CPGs and extracted information on recommended risk assessment tools; type of evidence about treatment benefits and harms; methods for linking risk estimates to treatment evidence and for developing treatment thresholds; and consideration of patient preferences. RESULTS: We identified 20 CPGs that made risk-stratified treatment recommendations out of 133 CPGs that made any type of treatment recommendations for the chronic diseases considered in this study. Of the included 20 CPGs, 16 (80%) used evidence about treatment benefits from randomized controlled trials, meta-analyses or other guidelines, and the source of evidence was unclear in the remaining four (20%) CPGs. Nine CPGs (45%) used evidence on harms from randomized controlled trials or observational studies, while 11 CPGs (55%) did not clearly refer to harms. Nine CPGs (45%) explained how risk prediction and evidence about treatments effects were linked (for example, applying estimates of relative risk reductions to absolute risks), but only one CPG (5%) assessed benefit and harm quantitatively and three CPGs (15%) explicitly reported consideration of patient preferences. CONCLUSIONS: Only a small proportion of CPGs for chronic diseases make risk-stratified treatment recommendations with a focus on heart disease and stroke prevention, diabetes and breast cancer. For most CPGs it is unclear how risk-stratified treatment recommendations were developed. As a consequence, it is uncertain if CPGs support patients and physicians in finding an acceptable benefit- harm balance that reflects both profile-specific outcome risks and preferences