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If a person is in diabetes remission, even if only for a short time, this reduces the risk of later diabetes complications and lowers healthcare costs. A recent study shows that long-term remission of type 2 diabetes can be achieved through calorie restriction using total diet replacement. However, this intervention involves support through face-to-face meetings every 2 to 4 weeks over a 2-year period, which is not feasible in routine care with limited resources. Therefore, we have developed an eHealth programme to help patients achieve diabetes remission through calorie restriction in a cost-effective manner. Our primary hypothesis is that an eHealth programme will be non-inferior to face-to-face meetings in helping patients with type 2 diabetes achieve remission through caloric restriction. Our second hypothesis is that eHealth support will be more cost-effective than face-to-face support.
The eHealth DIabetes remission Trial is a multicentre, two-arm, non-inferiority, open-label, randomised controlled parallel group trial with blinded endpoint assessment conducted at two centres in Sweden. The study duration is 2 years. People with type 2 diabetes (≤6 years duration) use total diet replacement (approximately 900 kcal/day) with the aim of losing 15 kg and achieving diabetes remission. Participants are randomly assigned to either the eHealth support group or the face-to-face support group. The treatment programme to achieve and maintain weight loss is the same in both groups, but the method of support differs between the groups. The primary outcome is haemoglobin A1c (HbA1c) after 1 year. The secondary outcome is HbA1c at 6 months and 2 years. Other important secondary outcomes are diabetes remission rate, body weight and cost-effectiveness. The latter is assessed using the incremental cost per quality-adjusted life-years gained.
The study was approved by the Swedish Ethical Review Authority (Dnr 2022-02242-01, 2023-03707-02). The results will be published in peer-reviewed scientific journals and discussed at national and international conferences and with patient organisations.
ClinicalTrials.gov (NCT05491005).
With recent efforts to eliminate visceral leishmaniasis in East Africa, we aimed to map the breadth of research on leishmaniases in Ethiopia, one of the high-endemic countries in the region, to help understand the current literature landscape and highlight priority areas for future research.
The scoping review was conducted in accordance with the JBI Scoping Review Methodology Group’s guidance and reported following Preferred Reporting Items for Systematic Reviews and Meta-Analyses—Extension for Scoping Reviews guidelines.
We searched the following databases and sources: PubMed, Embase, Web of Science, Cochrane Library, Global Medicus Index, PROSPERO, ClinicalTrials.gov and the Pan African Clinical Trials Registry and known local journals.
We included studies addressing the issue of leishmaniasis in Ethiopia that were published in English language.
Two reviewers independently extracted data from each study, with conflicts resolved by a third reviewer. The identified studies were analysed using an extensive codebook, which was previously developed by this team and adapted to the Ethiopian context to classify the research into different categories.
A total of 8698 articles were identified. A stepwise review was conducted, and 639 papers were selected for inclusion. The research spans different themes and designs and has steadily increased over the past 14 years. Research on prevention and control, health systems/policies and post-kala-azar dermal leishmaniasis, as well as randomised controlled trials, was lacking. Studies on coinfections with other diseases accounted for 14% of research.
The findings underscore the growing amount of research on leishmaniasis in Ethiopia, addressing several themes and emphasising the need for more research in prevention, control, health systems/policy and high-quality studies for evidence-based treatment.
Biological disease modifying antirheumatic drugs (bDMARDs) have a central role in the treatment of rheumatoid arthritis (RA). Tumour necrosis factor inhibitors (TNFis) are commonly used as first-line agents, while non-TNFis (tocilizumab, abatacept and rituximab) have shown to be non-inferior to TNFis in head-to-head trials. In case of TNFi inadequate response, using other mechanisms of action provides a better response than using an alternate TNFi. Which non-TNFi bDMARD administered subcutaneously to allow for ambulatory management to choose in case of first line TNFi inadequate response has not been tested in a randomised clinical trial, while observational data support a potential superiority of tocilizumab over abatacept.
The SUNSTAR (SUbcutaNeouS Tocilizumab vs Abatacept in TNF Alpha inadequate responders for the treatment of Rheumatoid arthritis) study is a 52-week prospective, randomised, multicentre, open-label, superiority phase IV trial comparing subcutaneous tocilizumab with abatacept in a 1:1 ratio. Patients with active RA (Disease Activity Score-erythrocyte sedimentation rate >3.2 and Clinical Disease Activity Index (CDAI) >10) and with inadequate 3-month response to a first or second TNFi are included in 25 centres in France. The primary outcome is the CDAI improvement at week 24. Intention-to-treat analysis will be applied primarily. The secondary outcome is a composite outcome of the percentage of responders defined as a CDAI
Ethics approval was obtained from the committee for the protection of persons (Comité de protection des personnes Sud Méditerranée I 17.00608.001744). The findings from this study, whether positive or negative, will be published in peer-reviewed journals and will be presented at national and international conferences. The results will inform future recommendations on the management of RA.
NCT03227419 and EudraCT2017-000947-41.
To identify, define and achieve consensus on perioperative patient safety indicators within a Swedish context.
A modified Delphi method.
A purposeful sample of 22 experts, all experienced operating room nurse specialists, was recruited for this study. A questionnaire was constructed incorporating statements derived from a preceding study. The experts were asked to rate the importance of each statement concerning patient safety during the perioperative phase. The data collection occurred through an online survey platform between November 2022 and April 2023. The CREDES checklist guided the reporting of this study.
The three-round Delphi study resulted in consensus on 73 statements out of 103, encompassing 74% process indicators and 26% structure indicators. Key areas of consensus included the use of the Surgical Safety Checklist and optimizing the operating room environment.
Consensus was reached on perioperative safety indicators, underscoring the intricate challenges involved in ensuring patient safety in the operating room. It emphasizes the important integration of both structure and process indicators for comprehensive safety assessment during surgical procedures. Recognizing the difficulty in measuring factors like teamwork and communication, essential for patient safety, the study offers practical guidance. It underlines a balanced approach and specific consensus areas applicable in clinical practice to enhance perioperative patient safety.
This study provides concrete practice guidance and establishes a structured framework for evaluating perioperative care processes. It emphasizes the critical role of professionals having the necessary skills and being present during surgical procedures. Additionally, the study underscores the paramount importance of effective communication and teamwork within the operating room team, substantively contributing to overall patient safety enhancement.
The study focused on addressing the challenge of ensuring patient safety in operating rooms, acknowledging the persistent complications related to surgery despite global efforts to eliminate avoidable harm in healthcare. Consensus was reached on 73 crucial indicators for perioperative patient safety, emphasizing a balanced approach integrating both process and structure indicators for a comprehensive assessment of safety during surgical procedures. The study has a broad impact on professionals and healthcare systems, providing concrete guidance for practice and offering a structured process for evaluating perioperative care.
The study is reported informed by ‘Guidance on Conducting and REporting DElphi Studies (CREDES) in palliative care: Recommendations derived from a methodological systematic review’.
No patient or public contribution.
FreshRSS 