[Information and active patient participation using an interactive booklet in the prescription of antihypertensive drugs in primary care]. / Information et participation active des patients à l'aide d'une brochure interactive lors de la prescription d'antihypertenseurs en soins primaires.

AIM: Antihypertensive drugs are thought to be responsible for adverse drug events in 25% of patients, with severe consequences in 13% of cases. The purpose of this study was to develop an interactive booklet designed to inform and involve patients with a view to preventing adverse drug events. METHODS: The development of the booklet involved several stages, including a literature review, a Delphi survey, a readability assessment, a qualitative study in primary care, a revision process, and graphic design work. 27 experts (patients, general practitioners, public health practitioners, cardiologists, geriatricians, psychologists, economists, pharmacists, nurses and ethicists) participated in the Delphi survey, while the qualitative study was based on a sample that included 7 doctors, 13 patients and 2 healthcare assistants. RESULTS: We developed an interactive booklet containing information items on the benefits and risks of antihypertensive drugs, a care plan to be completed by the patient, and a form for reporting adverse drug events. Ambiguous sentences and incomprehensible medical terms were rephrased. The time required to present the booklet and ease of use were key acceptability criteria for caregivers. Among the patients, the study found that interest in the booklet required clear evidence of an expected benefit. CONCLUSION: An understandable and acceptable interactive booklet was developed using a systematic process to prevent severe adverse drug events in primary care.

Nutritional Status of Vegetarian Patients Before and After Bariatric Surgery: a Monocentric Retrospective Observational Case-Control Study.

The obesity pandemic is associated with an increasing number of bariatric surgeries which allow improvement in obesity-related comorbidities and life expectancy but potentially induce nutritional deficiencies. Vegetarianism becomes more and more popular and exposes as well to vitamin and micronutrient deficiencies. Only one study has explored the impact of vegetarianism on the preoperative nutritional status of eligible patients for bariatric surgery, but none in postoperative care. MATERIALS AND METHODS: We conducted a retrospective case-control study in our cohort of bariatric patients, matching 5 omnivores for each vegetarian. We compared their biological profile regarding vitamin and micronutrient blood levels before and 3, 6, 12, and 30 months after surgery. RESULTS: We included 7 vegetarians including 4 lacto-ovo-vegetarians (57%), 2 lacto-vegetarians (29%), and one lacto-ovo-pesco-vegetarian (14%). Three years after surgery with equivalent daily standard vitamin supplementation, the two groups showed a similar biological profile including blood levels of ferritin (p = 0.6), vitamin B1 (p = 0.1), and B12 (p = 0.7), while the total median weight loss at 3 years was comparable (39.1% [27.0-46.6] in vegetarians vs 35.7% [10.5-46.5] in omnivores, p = 0.8). We observed no significant difference between vegetarians and omnivores before surgery regarding comorbidities and nutritional status. CONCLUSION: It seems that, after bariatric surgery, vegetarian patients taking a standard vitamin supplementation do not show an increased risk of nutritional deficiencies compared to omnivores. However, a larger study with a longer follow-up is needed to confirm these data, including an evaluation of different types of vegetarianism such as veganism.

Risk-Benefit Balance Associated With Obstetric, Neonatal, and Child Outcomes After Metabolic and Bariatric Surgery.

Importance: Metabolic and bariatric surgery (MBS) is the most efficient therapeutic option for severe obesity. Most patients who undergo MBS are women of childbearing age. Data in the scientific literature are generally of a low quality due to a lack of well-controlled prospective trials regarding obstetric, neonatal, and child outcomes. Objective: To assess the risk-benefit balance associated with MBS around obstetric, neonatal, and child outcomes. Design, Setting, and Participants: The study included 53 813 women on the French nationwide database who underwent an MBS procedure and delivered a child between January 2012 and December 2018. Each women was their own control by comparing pregnancies before and after MBS. Exposures: The women included were exposed to either gastric bypass or sleeve gastrectomy. Main Outcomes and Measures: The study team first compared prematurity and birth weights in neonates born before and after maternal MBS with each other. Then they compared the frequencies of all pregnancy and child diagnoses in the first 2 years of life before and after maternal MBS with each other. Results: A total of 53 813 women (median [IQR] age at surgery, 30 [26-35] years) were included, among 3686 women who had 1 pregnancy both before and after MBS. The study team found a significant increase in the small-for-gestational-age neonate rate after MBS (+4.4%) and a significant decrease in the large-for-gestational-age neonate rate (-12.6%). The study team highlighted that compared with pre-MBS births, after MBS births had fewer occurrences of gestational hypertension (odds ratio [OR], 0.16; 95% CI, 0.10-0.23) and gestational diabetes for the mother (OR, 0.39; 95% CI, 0.34-0.45), as well as fewer birth injuries to the skeleton (OR, 0.27; 95% CI, 0.11-0.60), febrile convulsions (OR, 0.39; 95% CI, 0.21-0.67), viral intestinal infections (OR, 0.56; 95% CI, 0.43-0.71), or carbohydrate metabolism disorders in newborns (OR, 0.54; 95% CI 0.46-0.63), but an elevated respiratory failure rate (OR, 2.42; 95% CI, 1.76-3.36) associated with bronchiolitis. Conclusions and Relevance: The risk-benefit balance associated with MBS is highly favorable for pregnancies and newborns but may cause an increased risk of respiratory failure associated with bronchiolitis. Further studies are needed to better assess the middle- and long-term benefits and risks associated with MBS.

The future of bariatric surgery research: A worldwide mapping of registered trials.

The bariatric surgery (BS) research landscape is a continuous evolving. Since the first described procedure, numerous different techniques have been developed by surgical teams. In this context, we conducted a systematic mapping of upcoming randomized controlled trials (RCTs) in BS for people with obesity. In June 2021, we performed a systematic review of RCTs evaluating BS versus another surgical procedure or versus a medical control group, through a search in ClinicalTrials.gov. There was no restriction on outcomes for study selection. A total of 62 RCTs were included, totaling 10,800 potential individuals to be included, with planned Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy surgeries the most common. The median number of patients planned to be enrolled is 78 (IQR: 50-143). Mean follow-up time is 12 months in 55% of trials and 4 years or more in 23%. The most frequent (81% of RCTs) outcomes to be investigated are obesity-related diseases with the study of type 2 diabetes, followed by weight loss, quality of life, and surgical complications. The rising number of BS procedures around the world has been followed by a subsequent surge in BS research. An increase in interest is observed in outcomes such as obesity-related diseases, intermediate metabolic markers, quality of life, and body composition.

Seventy years of bariatric surgery: A systematic mapping review of randomized controlled trials.

While research publications on bariatric surgery (BS) have grown significantly over the past decade, there is no mapping of the existing body of evidence on this field of research. We performed a systematic review followed by a mapping of randomized controlled trials (RCTs) in BS for people with obesity. From January 2020 to December 2020, we performed a systematic review of RCTs evaluating BS, versus another surgical procedure, or versus a medical control group, through a search of Embase and PubMed. There was no restriction on outcomes for study selection. A total of 114 RCTs were included, most (73.7%) of which were based on a comparison with Roux-en-Y gastric bypass (RYGB) and conducted between 2010 and 2020. Only 15% of the trials were multicenter and few (3.5%) were international. The median number of patients enrolled was 61 (interquartile range [IQR]: 47.3-100). Follow-up time was 1 to 2 years in 36% and 22.8% of the trials, respectively. Weight loss was the most studied criterion (87% of RCTs), followed by obesity-related diseases, and medical and surgical complications (73%, 54%, and 47% of RCTs, respectively). Nutritional deficiency frequency, body composition, and mental health were little studied (20%, 18% and 5% of RCTs, respectively). Our literature review revealed that much research in BS is wasted because of replication of RCTs on subjects for which there is already body of evidence, with small populations and follow-up times mostly below 2 years. Yet several research questions remain unaddressed, and there are few long-term trials. Future studies should take into account the experience of the past 70 years of research in this field.