Safety outcomes of direct oral anticoagulants in older adults with atrial fibrillation: a systematic review and meta-analysis of (subgroup analyses from) randomized controlled trials.

Balancing stroke prevention and risk of bleeding in patients with atrial fibrillation (AF) is challenging. Direct oral anticoagulants (DOACs) are by now considered standard of care for treating patients with AF in international guidelines. Our objective was to assess the safety of long-term intake of DOACs in older adults with AF. We included RCTs in elderly (≥ 65 years) patients with AF. A systematic search in MEDLINE and EMBASE was performed on 19 April 2022. For determination of risk of bias, the RoB 2 tool was applied. We pooled outcomes using random-effects meta-analyses. The quality of evidence was assessed using GRADE. Eleven RCTs with a total of 63,374 patients were identified. Two RCTs compared apixaban with either warfarin or aspirin, four edoxaban with either placebo, aspirin, or vitamin K antagonists (VKAs), two dabigatran with warfarin and three rivaroxaban with warfarin. DOACs probably reduce mortality in elderly patients with AF (HR 0.89 95%CI 0.77 to 1.02). Low-dose DOACs likely reduce bleeding compared to VKAs (HR ranged from 0.47 to 1.01). For high-dose DOACS the risk of bleeding varied widely (HR ranged from 0.80 to 1.40). We found that low-dose DOACs probably decrease mortality in AF patients. Moreover, apixaban and probably edoxaban are associated with fewer major or clinically relevant bleeding (MCRB) events compared to VKAs. For dabigatran and rivaroxaban, the risk of MCRB varies depending on dose. Moreover, subgroup analyses indicate that in the very old (≥ 85) the risk for MCRB events might be increased when using DOACs.Registration: PROSPERO: CRD42020187876.

Information needs of patients undergoing bariatric surgery in Germany: a qualitative study.

BACKGROUND: Obesity is a worldwide problem with different treatment options. Bariatric surgery is an effective treatment for severe obesity; however, it leads to drastic changes (e.g., changes in everyday life and eating behavior) for patients, which may lead to information needs. Our aim was to identify the information needs of patients undergoing bariatric surgery and to explore the information provision within the healthcare process of bariatric surgery in Germany. METHODS: We conducted a qualitative study (n = 14 single, semi-structured telephone interviews) between April 2018 and April 2019. The interview guide was designed prior to the interviews and consisted of four main sections (demographic information, pre-/postoperative healthcare provision, information needs). The interviews were transcribed verbatim and analyzed using qualitative content analysis with MAXQDA software. RESULTS: There were unmet information needs with two factors (time: pre/postoperative and categories of information: general/specific) to be considered. Due to the patients' description of information, we categorized information into general (different surgical procedures, general nutritional information) and specific (occurring simultaneously with a problem) information. Most patients felt well informed concerning general information. However, it was pointed out that it was not possible to provide complete information preoperatively, as the need for information only arises when there are postoperative (specific) problems. In addition, there seems to be a high demand for specific postoperative information regarding nutrition and nutrition-related problems. However, patients stated that postoperative nutritional counseling is not reimbursed by health insurance funds. The information conveyed in support groups and the exchange of experiences are highly valued by patients. However, some patients describe the information provided within the support groups as unfiltered, frightening or exaggerated. CONCLUSION: Overall, there were unmet information needs. Reimbursement by health insurance funds could increase the use of postoperative nutritional counseling and thus serve existing information needs. Support groups enable an exchange of experiences and therefore offer low-barrier access to information. Cooperation between support groups and healthcare professionals in information provision could be an approach to improving existing information needs or to avoiding the development of information gaps. Furthermore, the development and implementation of a digital solution for (postoperative) information dissemination could be helpful.

Safety of dipeptidyl peptidase-4 inhibitors in older adults with type 2 diabetes: a systematic review and meta-analysis of randomized controlled trials.

REGISTRATION: PROSPERO: CRD42020210645. INTRODUCTION: We aimed to assess the safety of dipeptidyl peptidase-4 (DPP-4) inhibitors in older patients with type 2 diabetes with inadequate glycaemic control. METHODS: We included randomized controlled trials (RCTs) in older (⩾65 years) patients with type 2 diabetes. The intervention group was randomized to treatment with any DPP-4 inhibitors. A systematic search in MEDLINE and Embase was performed in December 2020. For assessing the risk of bias, RoB 2 tool was applied. The quality of evidence was assessed using the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach. We pooled outcomes using random effects meta-analyses. RESULTS: We identified 16 RCTs that included 19,317 patients with a mean age of greater than 70 years. The mean HbA1c level ranged between 7.1 and 10.0 g/dl. Adding DPP-4 inhibitors to standard care alone may increase mortality slightly [risk ratio (RR) 1.04; 95% confidence interval (CI) 0.89-1.21]. Adding DPP-4 inhibitors to standard care increases the risk for hypoglycaemia (RR 1.08; 95% CI 1.01-1.16), but difference in overall adverse events is negligible. DPP-4 inhibitors added to standard care may reduce mortality compared with sulfonylureas (RR 0.88; 95% CI 0.75-1.04). DPP-4 inhibitors probably reduce the risk for hypoglycaemia compared with sulfonylureas (magnitude of effect not quantifiable because of heterogeneity) but difference in overall adverse events is negligible. There is insufficient evidence on hospitalizations, falls, fractures, renal impairment and pancreatitis. CONCLUSION: There is no evidence that DPP-4 inhibitors in addition to standard care decrease mortality but DPP-4 inhibitors increase hypoglycaemia risk. Second-line therapy in older patients should be considered cautiously even in drugs with a good safety profile such as DPP-4 inhibitors. In case second-line treatment is necessary, DPP-4 inhibitors appear to be preferable to sulfonylureas. PLAIN LANGUAGE SUMMARY: Safety of dipeptidyl peptidase-4 inhibitors in older adults with type 2 diabetes: Introduction:: We performed the review to assess the safety of dipeptidyl peptidase-4 (DPP-4) inhibitors in older type 2 diabetes patients with blood sugar outside the normal level.Methods:: To answer the question, we searched various electronic databases. We included studies in older (⩾65 years) patients with type 2 diabetes that assessed the safety of DPP-4 inhibitors. The data from the different studies were quantitatively summarized using statistical methods. We assessed the quality of the data to judge the certainty of the findings.Results:: We identified 16 studies that included 19,317 patients with a mean age greater than 70 years. The average blood sugar level of patients in the included studies was slightly or moderately increased. Adding DPP-4 inhibitors to standard care alone may increase mortality slightly. Adding DPP-4 inhibitors to standard care increases the risk for hypoglycaemia, but difference in overall adverse events is negligible. DPP-4 inhibitors added to standard care may reduce mortality compared with sulfonylureas. DPP-4s probably reduce the risk of hypoglycaemia compared with sulfonylureas (magnitude of effect not quantifiable because of heterogeneity) but difference in overall adverse events is negligible. There is insufficient evidence on hospitalizations, falls, fractures, renal impairment and pancreatitis.Conclusion:: There is no evidence that DPP-4 inhibitors in addition to standard care decrease mortality but DPP-4 inhibitors increase the risk that blood sugar falls below normal. Adding DPP-4 inhibitorss to standard care in older patients should be considered cautiously even in drugs with a good safety profile such as DPP-4 inhibitors. In case additional treatment is necessary, DPP-4 inhibitors appear to be preferable to sulfonylureas.

Healthcare delivery and information provision in bariatric surgery in Germany: qualitative interviews with bariatric surgeons.

BACKGROUND: There are several healthcare professionals involved in health information provision regarding bariatric surgery, such as bariatric surgeons, nutritionists, and medical doctors in outpatient settings. Trustworthy health information supports patients in understanding their diagnosis, treatment decisions, and possible prognosis. Therefore, it is necessary to provide health information on bariatric surgery. This study has two distinct objectives. The first is to outline the delivery of healthcare regarding bariatric surgery in Germany. The second is to describe the information provision within healthcare delivery. METHODS: We conducted 15 semi-structured telephone interviews with bariatric surgeons between April 2018 and February 2019. The interviews were audio recorded and transcribed verbatim. The interview guide consisted of four sections (information about the clinic/surgeon and surgical procedures, preoperative procedure, postoperative procedure, information needs). The transcribed interviews were analyzed using qualitative content analysis supported by MAXQDA software. RESULTS: The pre- and postoperative processes differed substantially between clinics. Additionally, every bariatric clinic had its own information provision concept. There were several cost-related issues the surgeons claimed to be relevant for patients, such as nutritional blood tests or postoperative psychotherapy. These issues were often caused by unclearness of responsibility within the medical disciplines involved. CONCLUSION: Healthcare delivery in bariatric surgery in Germany is heterogeneous in terms of pre- and postoperative care. Therefore, preoperative information provision between the clinics differs. The impact of this heterogeneous healthcare delivery and information provision on patients' information needs regarding bariatric surgery should be further investigated among patients and other healthcare professionals involved.

Psychosocial Changes of Bariatric Surgery in Patients' Everyday Life: a Scoping Review.

PURPOSE: Although the post-bariatric clinical and physical changes are well-known, the psychosocial changes in patients' everyday life are less clear. Therefore, we tried to summarize comprehensively the currently available literature on the psychosocial changes of bariatric surgery (BS) by means of a scoping review. MATERIALS AND METHODS: The scoping review was conducted following the Arksey and O'Malley framework, the Joanna Briggs Institute Reviewer's Manual 2015, and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR) checklist. PubMed, EMBASE, and PsycINFO were searched for data dating from January 2008 through October 2019. Only gastric bypass and sleeve gastrectomy procedures were considered for this review. To explore and describe the essence of the experienced changes deeply, only qualitative studies were included. The synthesis was performed using the qualitative content analysis technique. RESULTS: The literature search yielded 1420 unique records, and 1371 articles were eliminated on the basis of irrelevant title and/or abstract. Forty-nine full-text articles were reviewed. Ultimately, eight articles were included in this scoping review. The qualitative content analysis emerged in 12 categories, which were further condensed into three major thematic areas, namely, "subjective self-image," "interpersonal relationships," and "it's not all gold that glitters," which reflect the post-operative psychosocial changes. CONCLUSION: A wide range of psychosocial changes occurs following bariatric surgery. To maintain the improvements and to prevent negative changes, long-term support by specially trained health professionals is crucial.

More systematic reviews were registered in PROSPERO each year, but few records' status was up-to-date.

OBJECTIVES: To determine the proportion of systematic reviews (SRs) registered in PROSPERO and explore differences between publication years, review focus, and country. Secondary objectives were (1) to compare the characteristics of registered and nonregistered SRs and (2) to assess the up-to-dateness of the PROSPERO records' status. STUDY DESIGN AND SETTING: In November 2018, we searched PubMed for SRs that were eligible for registration in PROSPERO. We included a random sample of n = 500 SRs. Data were analyzed descriptively. RESULTS: Overall, 76 (15.2%) of the included SRs had been registered in PROSPERO. This proportion has increased with each year, up to 31.6% (36/114) in 2018. It did not notably differ depending on the reviews' focus. SRs from the United States or China were generally registered less frequently and SRs from Australia or Canada more frequently. Registered and nonregistered SRs did not differ regarding the number of authors or the time from submission to publication or from search to submission and publication. We could analyze 75 PROSPERO records, of which 63 (84.0%) were not up-to-date. Most SRs (49/75; 65.3%) were still listed as "ongoing." CONCLUSION: More SRs were registered in PROSPERO each year, but only few records' status was up-to-date.