Given the challenges with nutrition research, the Canadian Nutrition Society and Intertek Health Sciences Inc held an expert consultation in late 2019 to discuss the development and implementation of best practices for clinical trials on whole foods. Key challenges in the design, interpretation, and reporting of clinical efficacy studies on whole foods and opportunities for the future development of best practices are reported. Novelty: Outlines existing tools, resources, and checklists for clinical nutrition trials and provides clear and tangible steps to develop best practices for studies on whole foods.

To provide up-to-date evidence-based guidelines for the management of smoking cessation during pregnancy.
Systematic review of the international literature. We identified papers published between January 2003 and April 2019 in Cochrane PubMed, and Embase databases with predefined keywords. All reports published in French and English relevant to the areas of focus were included and classified according the level of evidence ranging from 1 (highest) to 4 (lowest). The strength of the recommendations was classified according to the Haute Autorité de santé, France (ranging from A, highest to C, lowest).
\"Counseling\", involving globally all kind of non-pharmacological interventions, has a modest benefit on smoking cessation, birth weight and prematurity. Moderate physical activity did not show a significant effect on smoking cessation. The systematic use of feedback by measuring the expired air carbon monoxide concentration do not influence smoking abstinence but it may be used in establishing a therapeutic alliance. The use of self-help interventions and health education are recommended in helping pregnant smokers quit. The prescription of nicotine replacement therapies (NRT) may be offered to any pregnant woman who has failed stopping smoking without medication This prescription can be initiated by the health care professional taking care of the pregnant woman in early pregnancy. There is no scientific evidence to propose the electronic cigarette for smoking cessation to pregnant smokers; it is recommended to provide the same advice and to use methods that have already been evaluated. The use of waterpipe (shisha/narghile) during pregnancy is associated with decreased fetal growth. It is recommended not to use waterpipe during pregnancy. Breastfeeding is possible in smokers, but less often initiated by them. Although its benefit for the child\'s development is not demonstrated to date, breastfeeding allows the mother to reduce or stop smoking. The risk of postpartum relapse is high (up to 82% at 1 year). The main factors associated with postpartum abstinence are breastfeeding, not having a smoker at home, and having no symptoms of postpartum depression.
Smoking during pregnancy concerns more than hundred thousand women and their children per year in France. It is a major public health burden. Health care professionals should be mobilized for reducing or even eradicating it.

Randomized clinical trials are considered as the preferred design to assess the potential causal relationships between drugs or other medical interventions and intended effects. For this reason, randomized clinical trials are generally the basis of development programs in the life cycle of drugs and the cornerstone of evidence-based medicine. Instead, randomized clinical trials are not the design of choice for the detection and assessment of rare, delayed and/or unexpected effects related to drug safety. Moreover, the highly homogeneous populations resulting from restrictive eligibility criteria make randomized clinical trials inappropriate to describe comprehensively the safety profile of drugs. In that context, observational studies have a key added value when evaluating the benefit-risk balance of the drugs. However, observational studies are more prone to bias than randomized clinical trials and they have to be designed, conducted and reported judiciously. In this article, we discuss the strengths and limitations of randomized clinical trials and of observational studies, more particularly regarding their contribution to the knowledge of medicines\' safety profile. In addition, we present general recommendations for the sensible use of observational data.

OBJECTIVE: There is limited evidence with respect to the between-group effects of various angiotensin receptor blockers (ARBs) on blood pressure and albuminuria in patients with type 2 diabetes mellitus. Therefore, we aimed to investigate the effects of differing ARBs on systolic blood pressure (SBP) and the albumin-creatinine ratio after 1 year in a large cohort of patients with type 2 diabetes mellitus.
METHODS: In 2007, 24 940 primary care patients with type 2 diabetes mellitus participated in the Zwolle Outpatient Diabetes project Integrating Available Care (ZODIAC) study, a prospective observational cohort study. Patients were included in the current study if they were prescribed an ARB in 2007 and if 1-year follow-up data were available. The final study population comprised 3610 patients. Multivariate mixed-model analyses were performed to estimate effects of the various ARBs on SBP and albuminuria. Stratified subgroup analyses were performed according to baseline hypertension and albuminuria.
RESULTS: SBP decreased in all groups, the largest decrease being observed in the group receiving telmisartan. No significant or relevant changes over time were observed among groups for SBP and albuminuria. In the subgroup (n=1225) of normotensive patients, telmisartan was associated with a larger decrease in SBP after 1 year compared to other ARBs, without different effects on the albumin-creatinine ratio.
CONCLUSIONS: We observed no differences in effects on SBP and the albumin-creatinine ratio among differing ARBs in patients with type 2 diabetes mellitus.

Evidence-based medicine is a paradigm founded on a hierarchy of research design, accepted as a dogma. Applied to radiation oncology, and specifically to radiotherapy technical comparisons, evidence-based medicine implies methodological and ethical problems. The concept of \"incremental\" evolution and the dosimetric evidence are proposed as an acceptable alternative to comparative clinical trials if total dose, time, fractionation, and target volumes are not modified. For other situations, either randomized comparative trials or observational studies are needed. When randomized comparative trials are not possible, observational studies, whose validity can be enhanced by appropriate methodology, must be considered as a valid method.