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The Institute for Health Sciences of Aragon (IACS) has coordinated the development of a clinical practice guideline (CPG), funded by the Spanish Ministry of Health, for managing antidiabetic drugs in patients with type 2 diabetes mellitus. We conducted a living systematic review to provide a continuously updated evidence summary for formulating living recommendations on intensifying basal insulin therapy by comparing glucagon-like peptide-1 (GLP-1) receptor agonists with rapid-acting insulin.
Methods
In 2021, the IACS joined the Living Evidence to Inform Health Decisions (LE-IHD) project, which includes the use of technological tools to identify early emerging evidence on a defined topic. We conducted searches in the centralized Living Overview of Evidence (LOVE) and Epistemonikos databases. Specifically, the LOVE topic of interest from which the articles were selected was “glucagon-like peptide analogs and agonists for diabetes mellitus”. We applied the GRADE approach to rate the certainty of evidence and to develop clinical practice recommendations.
Results
The initial baseline report included six randomized controlled trials (RCTs). We have continuously monitored the evidence and performed a monthly screening. Only one RCT was identified in the first update. The Guideline Development Group (GDG) decided to formulate a strong recommendation in favor of GLP-1 receptor agonists. The GDG considered the reduction in the risk of severe hypoglycemia events among patients treated with GLP-1 receptor agonists, compared with rapid insulin, particularly significant as well as the greater improvement in patient quality of life. Since the guideline was formulated, no new evidence has been identified that would change the recommendation.
Conclusions
Adoption of the living systematic approach underscores the commitment to providing continuously updated recommendations within CPGs. Utilizing the GRADE approach, the Guideline Development Group decided to formulate a strong recommendation in favor of GLP-1 receptor agonists over rapid insulin. No new evidence has emerged to alter this recommendation. The living systematic review will remain active, ensuring continuous monitoring until the final draft CPG is disseminated.
In collaboration with a European Reference Network for rare diseases, we aimed to identify red flags for the diagnosis of rare and complex connective tissue and musculoskeletal diseases (rCTDs). Some indicators, presented as red flags, might raise clinicians’ awareness about the presence of rCTDs. Their identification is critical in primary care, where they are most likely to be first observed.
Methods
Firstly, we conducted a scoping review to identify red flags already published in the scientific literature. We included studies about people with rCTDs that described red flags, warning signs, alarm symptoms, and pathognomonic signs identifiable in a primary care setting. Then, we conducted a systematic review of evidence pointing out which signs and symptoms should arouse suspicion specifically for IgG4-related disease. We included studies providing estimates of diagnostic precision or prevalence of signs and symptoms, and we assessed their quality and applicability to the review question. We conducted systematic searches in major medical databases and manual searches in rare disease resources.
Results
For the scoping review, 49 studies out of 1,656 records met the inclusion criteria. Two reported red flags for autoimmune diseases altogether, and 14 described red flags for systemic sclerosis. For the systematic review, seven studies out of 4,477 records met the criteria, comprising five diagnostic precision studies and two large case series. These were generally rated as having a high risk of bias and were included as indirect evidence. We identified 32 potential IgG4-related disease red flags, 10 related to clinical history findings and basic signs or symptoms, and eight belonging to common laboratory findings and basic imaging techniques.
Conclusions
Red flags for rCTDs have generally been established through expert consensus and lack valid indicators for diagnosis, such as sensitivity, specificity, or predictive values. They frequently overlap among different rCTDs. Potential red flags are prone to change as further evidence emerges. This shows the need to collaborate with reference networks to address rare diseases where the evidence is still scarce.
Patients have knowledge, perspectives and experiences that are unique and can make an essential contribution to Health Technology Assessment (HTA). However, in order for their participation to be effective, they need to be able to understand how HTA reports are generated and the decision-making processes that they inform. The aim is to describe the development and virtualization of training materials for patients, as well as to their implementation in a pilot study.
Methods
A working group from Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS) agencies was created to develop educational materials in collaboration with patients. The content was based on international initiatives and feedback from the working group. The project was initiated in November 2020. The team consisted of HTA researchers, technicians with experience in training and virtualization and patients. The final version was obtained after an iterative process and refinement of the content and design.
Results
The materials were published in complete and summary versions, and they were translated into Catalan, Basque and Galician. The online course was designed in an e-learning platform (Moodle) with the aim of being implemented by each of the agencies. The materials include relevant and summarized information on HTA processes, current framework at national and European level, and the role of patients in HTA. Health research and the importance of qualitative and quantitative methods are also addressed. The course also includes a module of practical aspects of patient and citizen participation for achieving an effective contribution to HTA. The course is being piloted with patients in different regions in Spain. The objective of the pilot is to evaluate the usefulness and satisfaction with the course, and it has been designed with the purpose of incorporating the pertinent modifications in the course.
Conclusions
The online training course is intended to facilitate the acquisition of knowledge related to the processes and tools of HTA for patients, as well as to inform them in what phases and in what way they can participate. The pilot will provide relevant information on its use in practice. It is expected that the course will favor capacity building and patient involvement.
The Spanish Network of Agencies for Assessing National Health System Technologies and Performance (RedETS) defined a patient involvement (PI) framework for health technology assessment (HTA) activities in 2016. The aim of this study is to evaluate the process and impact of those PI initiatives that were implemented in the first year following the publication of this new framework.
Methods
A survey was sent to those HTA researchers who implemented PI in RedETS projects. Responses were reviewed by two authors. An adapted thematic analysis was performed and the results were later discussed by all authors.
Results
Six responses from six agencies/units were analyzed. The objectives of PI initiatives were the following: inclusion of patient perspectives, preferences and values; elicitation of important health outcomes measures; and barriers, facilitators, or suggestions for implementation. Different methods were used for PI: surveys, focus groups, in depth interviews, and participation in an expert panel. Five main themes emerged: (i) challenges with the recruitment process, (ii) needs identified, (iii) impact of PI, (iv) lessons learned, and (v) suggestions for the future.
Conclusions
PI initiatives within the RedETS framework were tailored to each HTA project, its specific goals and the individual needs and resources of each HTA agency. The results also pointed out how PI has a relevant impact that has enriched RedETS products providing key information on experiences, values, and preferences of patients, contributions that benefit the HTA and the process of drawing up recommendations. The main challenges were related to recruitment processes and capacity building.
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