Objective To evaluate the comparative effectiveness and safety of pharmacological and non-pharmacological smoking cessation interventions in people with severe mental illnessDesign Systematic review and network meta-analysis.Data sources Medline, Embase, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science, from inception to 19 September 2024.Eligibility criteria for selecting studies Trials enrolling adults who had established diagnoses of schizophrenia, bipolar disorder, recurrent or current severe major depressive disorder, or post-traumatic stress disorder, randomised to a smoking cessation intervention versus another active treatment, placebo, standard care, or no treatment.Results 74 randomised controlled trials (11 023 participants) evaluating nine smoking cessation interventions were included in the study. Compared with placebo or minimal care, varenicline (10 more per 100 achieving long term smoking abstinence, 95% confidence interval (CI) 5 to 16; high certainty evidence) and bupropion (5 more per 100, 1 to 10; moderate certainty evidence) increased long term abstinence. Effects on short term smoking abstinence were similar. Nicotine replacement therapy improved short term abstinence but with little or no long term abstinence benefit (moderate certainty evidence). Combination interventions (pharmacological with non-pharmacological interventions) may increase long term abstinence (6 more per 100, 95% CI 3 to 11; low certainty evidence). The certainty of evidence for other interventions was very low. Serious adverse event data were highly uncertain. Dropout from a trial because of harms was possibly no different for varenicline, bupropion, and nicotine replacement therapy compared with placebo or minimal care.Conclusions Varenicline, bupropion, and nicotine replacement therapy likely improved smoking abstinence in people with severe mental illness compared with placebo or minimal care (moderate to high certainty evidence). Combined pharmacological and non-pharmacological approaches may offer more benefit (low certainty evidence), but the risk of serious adverse events for all interventions was very uncertain.Systematic review registration PROSPERO CRD42022349498.
Shared decision making (SDM) is a process to actively involve both patients and clinicians to weigh the benefits and risks of a healthcare decision, based on clinical guidelines and the patients’ preferences, needs and values. Despite the ethical foundation of SDM, its implementation remains limited. Possible physician-reported barriers for this limited uptake include insufficient level of SDM training. Training physicians in SDM could be a part of the puzzle. A recent systematic review showed that there is a shift towards blended training more than live or online learning. We therefore developed and pilot-tested a blended training program for general practitioners (GPs) in SDM in Belgium. Acquired skills were evaluated by three viewpoint – observer, patient and physician. In a pre-post study, GPs participated in the blended training program consisting of an e-learning and a face-to-face session with simulation patients (SPs) GPs and SPs completed surveys before (T0) and after (T1) the blended training. Consultations were recorded for analysis by observer reported scales (OPTION12 and 4SDM scale). Secondary outcomes were SDM-Q9-patient, satisfaction with consultation, knowledge and intentions towards SDM. Ten GPs were included. There was a significant increase in both OPTION12 (mean (SD) from 19·37 before to 37·70 after training, p = 0·0010, 95
Objective To identify values and preferences regarding smoking cessation interventions among adults with severe mental illnessDesign Systematic review with best-fit framework synthesisData sources MEDLINE, EMBASE, Web of Science, CINAHL and Scopus from inception to 14 November 2025.Study selection Studies with any design, in any clinical and geographical setting, reporting on adult (18+) current or past smokers with a diagnosis of schizophrenia, bipolar or mood disorder, including major depressive disorder or post-traumatic stress disorder. We selected all quantitative and qualitative findings regarding patients’ values and preferences, including beliefs, attitudes, behaviours and perceived barriers and facilitators, in relation to smoking cessation interventions.Data extraction and synthesis Two reviewers independently screened studies. After a pilot to increase accuracy, data were extracted by one reviewer and verified by another. Risk of bias was assessed using the Mixed Methods Appraisal Tool. We used the best-fit framework synthesis methodology to synthesise the data.Results Of 14 970 identified articles, 65 were included. Most studies were of moderate to high quality. Financial costs posed a significant barrier, while education and social support emerged as important facilitators. Patients preferred personal interactions with healthcare providers. Their motivation for cessation varied and was influenced by habits and perceived nicotine dependence. Health concerns and financial savings were primary drivers for reflective motivation. Beliefs regarding treatment varied. Although commonly used, scepticism about nicotine replacement therapy and concerns about the long-term safety of electronic delivery systems were reported. Overall, patients preferred personalised, flexible programmes and emphasised the need for tailored approaches. Digital interventions, especially mobile apps, that provide support, motivational content and relevant information, were perceived as appealing and helpful when sufficiently considering accessibility and usability aspects. Patients commonly perceived smoking as a coping mechanism for negative emotions. Developing new coping strategies and creating smoke-free environments were deemed to contribute to successful cessation.Conclusions Patient-centred care for people with severe mental illness should leverage behavioural and pharmacological strategies for smoking cessation. Flexibility, accessibility and ongoing support appeared important for addressing stress, withdrawal symptom interpretation and relapse vulnerability in this population.PROSPERO registration number CRD42022337933.
Background Electronic health records (EHRs) can potentially revolutionize primary care by enhancing data storage, communication, and quality measure reporting. The COVID-19 pandemic accelerated the adoption of digital tools in Belgium, highlighting the potential of EHR data in audit and feedback (A&F) strategies. This study aims to outline the design and national implementation process of automated A&F monitoring instruments (locally known as barometers), in Belgian primary care.Methods Using Clinical Performance Feedback Intervention Theory, we developed three monitoring instruments for primary care: COVID-19 vaccination coverage, type 2 diabetes management, and appropriate antibiotic use. Quality indicators were selected at the national level using a Rand-modified Delphi method and validated by the Flemish Institute for Quality of Health Care (VIKZ). Data were collected from general practitioners' EHR systems, aggregated at the practice level, and analyzed using the Healthdata.be platform. Feedback was provided through the Healthstat.be interface, incorporating local and regional benchmarks and evidence-based recommendations.Results The COVID-19 vaccination monitoring instrument included 5223 GPs from 2269 practices, the type 2 diabetes monitoring instrument involved 9373 GPs from 3596 practices, and the antibiotics monitoring instrument covered 10 486 GPs from 3724 practices. These monitoring instruments collectively covered approximately eight million patients. Feedback reports were designed to be low in cognitive load, frequent, and benchmarked against the best-performing decile of practices. Integration of active, in-EHR delivery and formal evaluation of use are planned for future phases.Conclusion The implementation of automated A&F instruments in Belgian primary care demonstrated the feasibility and scalability of such systems. These monitoring instruments can provide valuable insights for quality improvement and support the transition toward a Learning Health System. Future work will focus on expanding the range of monitoring instruments and integrating active feedback mechanisms within EHR systems.
Background. The use of telemedicine in dermatology is becoming more popular in Belgium and other countries as a result of increasing waiting lists. The objective of this study was to analyze if tele-dermatology is a valuable alternative for in-person consultations with the dermatologist and to get insight into the content of the remote consultations, the use, the barriers, and the satisfaction with this system.Methods. This study was a 1-year prospective pilot study in Belgium. The study implemented and evaluated a store-and-forward tele-dermatology system in the routine practice of Belgian family physicians and dermatologists.Results. A total of 320 family physicians and 43 dermatologists participated in the study. Analysis of remote consultations revealed a median response time of 24 h; 21% of patients needed an additional in-person consultation after the remote consultation. The majority of dermatologists (67.9%), family physicians (86.6%), and patients (81.4%) were generally satisfied with the service. A majority of the dermatologists agreed that there was sufficient clinical information in the electronic form (60.7%) and that the quality of the pictures was sufficient to allow correct decision making (57.1%). The family physicians had significantly higher percentages respectively, 84.5% and 71.8%. Dermatologists reported technical (73.9%) and organizational (43.5%) problems, whereas these percentages were statistically lower, respectively, 35.2% and 28.2% for the family physicians.Conclusions. The store-and-forward tele-dermatology system had the potential to allow a smooth transfer of high-quality dermatologic advice. Although there were differences between the dermatologists, the family physicians and the patients, general satisfaction with the system was high. There is a need for an extramural order management system in which the dermatologist could answer from his own electronic medical records.
Shared decision making (SDM) balances patient preferences with clinical evidence but remains inconsistently practiced. Training physicians during undergraduate medical education (UME) is a proposed strategy, yet theoretical understanding of educational SDM interventions is lacking. We aim to understand how educational SDM interventions in UME work, in what circumstances and why. We conducted a realist review following RAMESES standards. We developed an initial program theory through analysis of a scoping literature review and expert interviews. A systematic literature search across 11 databases then identified relevant studies, which were analyzed to uncover context-mechanism-outcome configurations (CMOs). These informed the development of a final program theory (FPT) through interpretative synthesis. From 17 studies, we identified 22 CMOs grouped into six themes: building a theoretical foundation, integrating theory and skills, congruence with clinical tasks, contextualizing SDM learning, stimulating professional identity formation and enablers. Our FPT describes that educational SDM interventions focused on building a theoretical foundation, integrating theory and skills and professional identity formation work when they are scaffolded, congruent with future clinical tasks and contextualized. A supportive learning environment, sufficient time allocation, faculty development and self-regulated learning enable the educational SDM interventions to work more effectively. Intended outcomes are motivation, self-efficacy, shared professional values and SDM competence. This realist review provides a theoretical framework on how educational SDM interventions in UME work, in what circumstances and why. Research is needed to test and refine our theory, especially to further explore how specific UME settings influence learning.
BACKGROUND:The use of shared decision-making (SDM) in mental healthcare has been viewed as at least as important as its use in non-mental healthcare settings, but it still does not routinely take place in this setting. To further explore SDM processes with people with lived experience, we provide a qualitative meta-summary on patient-reported barriers and facilitators to participation in SDM within the context of mental healthcare. METHODS:Within the set of selected studies for a larger qualitative meta-summary, using five databases, we selected the studies that had surveyed patients with mental illness for further analysis in this paper. Search terms were based on the concepts: 'decision making', 'patient participation', 'patient perceptions' and 'study design' of patient reporting, including patient surveys, interviews and focus groups. RESULTS:Out of the 90 studies that had been selected for the larger review, we selected 13 articles concerning mental illness for more detailed analysis in this review. In total, we identified 29 different influencing factors and we found 6 major barriers: 'Lack of choice', 'Not being respected as a person', 'Feeling stigma from physician', 'Disease burden', 'Power imbalance' and 'Low self-efficacy to participate'. 'Clear information provision about options', 'Being respected as a person, being taken into account', 'Good physician-patient relationship' and 'Belief in the importance of one's own role' were the main facilitators. CONCLUSIONS:Stigma and self-stigma still seem to persist in mental healthcare and continue to suppress patients' self-efficacy to participate in SDM in this setting. There is much discussion of inclusion and diversity worldwide, and these themes are just as topical for patients with mental health problems. Further work seems necessary to eradicate all stigma and self-stigma in this setting when striving for care that could be 'as shared as possible'. PATIENT AND PUBLIC CONTRIBUTION:The authors wish to thank Mr. Walter Geuens, a person with lived experience in mental healthcare, for his careful reading and thorough feedback on the final paper.
RATIONALE:The global burden of death and disability is significantly influenced by illness and injury, which can occur at any time and anywhere. When these conditions are acute or life-threatening, immediate care outside the hospital becomes crucial. In these situations, first aid provided by laypeople (i.e. individuals without formal healthcare education) is a vital component of the prehospital care system, playing an important role in preserving life, alleviating suffering, preventing further harm, and promoting recovery. Therefore, training laypeople in first aid is widely assumed to increase first aid-related competencies and, hence, may improve the health outcomes of suddenly ill or injured individuals. OBJECTIVES:The main objective is to assess the effects of first aid training for laypeople compared with another type of training or no training on the health outcomes of people receiving first aid, the quality of the first aid provided, and the helping behaviour of people providing first aid. Secondary objectives are to assess the effects of first aid training for laypeople compared with another type of training or no training on first aid-related educational outcomes, including knowledge, skills, self-efficacy, and willingness to help, and adverse effects. SEARCH METHODS:We searched CENTRAL, MEDLINE, Embase, four other databases and two trials registries, together with reference and citation checking. We handsearched the websites of organisations, journals, and conference proceedings. The latest search date was 16 December 2024. ELIGIBILITY CRITERIA:We included randomised controlled trials (RCTs) and cluster-RCTs in laypeople comparing physical health first aid training with no first aid training (i.e. another type of training or no training). OUTCOMES:Our critical outcomes are the health outcomes of people receiving first aid, the quality of the first aid provided, and the helping behaviour of people providing first aid. Our important outcomes are first aid-related knowledge, first aid-related skills, self-reported first aid-related self-efficacy, and self-reported first aid-related willingness to help. RISK OF BIAS:We used the Cochrane Risk of Bias 2 tool (RoB 2) to assess bias in RCTs and its extension in cluster-RCTs. SYNTHESIS METHODS:When possible, we synthesised results for each outcome using meta-analysis of risk ratios (RR) and ratio of means (RoM) with 95% confidence intervals (CI) for dichotomous and continuous outcomes, respectively. When meta-analysis was not feasible due to the nature of the data, we followed the synthesis without meta-analysis (SWiM) principles and summarised results using vote counting based on the direction of effect. We applied GRADE to assess the certainty of the evidence for each outcome. INCLUDED STUDIES:We included 36 RCTs (21 individual and 15 cluster-RCTs) with a total of 15,657 participants. Thirty-four studies (94%) were conducted in high- or upper-middle-income countries, and only two in low- or lower-middle-income countries. Seventeen studies evaluated adult populations (≥ 18 years; 4542 participants), whereas 19 studies included child or adolescent populations (< 18 years; 11,115 participants). First aid training components, such as content, didactic approach, mode of delivery, duration, frequency, and instructor, varied substantially across studies. Similarly, studies measured outcomes using different tools and scales at various time points. SYNTHESIS OF RESULTS:Critical outcomes None of the included studies reported on the health outcomes of people receiving first aid or the quality of first aid provided. The evidence is very uncertain about the effect of first aid training on helping behaviour (1 study, 3070 participants; very low-certainty evidence), due to very serious risk of bias and serious imprecision. Important outcomes First aid training compared to no first aid training probably increases acquisition of first aid-related knowledge (RoM 1.58, 95% CI 1.37 to 1.82; I² = 93%; 8 studies, 3515 participants; moderate-certainty evidence), skills (RR 2.53, 95% CI 1.81 to 3.55; I² = 92%; 12 studies, 3063 participants; moderate-certainty evidence), and self-efficacy (RR 1.91, 95% CI 1.23 to 2.97; I² = 50%; 2 studies, 285 participants; moderate-certainty evidence), measured within one month after the end of the training (i.e. in the short term). The evidence is very uncertain about the effect of first aid training on willingness to help in the short term (RoM 1.02, 95% CI 0.97 to 1.07; I² = 85%; 2 studies, 1083 participants; very low-certainty evidence). We judged the overall risk of bias for the 36 included studies to be either high or of some concern, except for one study, which was at low risk of bias. Lack of blinding of the outcome assessors and a large amount of missing outcome data were the most common methodological issues. The serious or very serious risk of bias was the primary reason for downgrading the certainty of the evidence in this review. AUTHORS' CONCLUSIONS:Our review found no studies that compared the effects of first aid training to no first aid training on the health outcomes of people receiving first aid or the quality of first aid provided. There were insufficient data to draw conclusions about the impact on helping behaviour. Nevertheless, in the short term, first aid training probably increases the acquisition of knowledge, skills, and self-efficacy. But the evidence regarding its effect on willingness to help in the short term remains very uncertain. FUNDING:This Cochrane review had no dedicated funding but was supported by internal sources from the Foundation for Scientific Research of the Belgian Red Cross-Flanders. REGISTRATION:Protocol available via doi.org/10.1002/14651858.CD015538.
OBJECTIVE:We aim to provide an updated literature overview on patient-reported barriers and facilitators to participation in SDM across different patient groups and healthcare settings to uncover the 'common ground' and to reach for a more generalizable, uniform and inclusive insight in patients' perspective on participation in SDM. METHODOLOGY:We conducted a qualitative meta-summary, using five databases. Search terms were based on the concepts: 'decision-making', 'patient participation', 'patient perceptions' and 'study design' (of patient reporting). RESULTS:We found 9265 unique references, selected 209 studies for further sampling and finally withheld 90 studies for further analysis in this review. In total, we identified 34 different barriers and facilitators. Based on most frequently reported barriers and facilitators, we defined four broad analytical themes corresponding to patients' shared expectations concerning doctors', patients' and others' facilitative roles in SDM: (1) 'Doctors explaining well', (2) 'Doctors listening well, and fostering a trusting relationship', (3) 'Patients being assertive, (4) 'Patients being socially supported'. CONCLUSION:The majority of barriers and facilitators we found transcended differences in patient characteristics or healthcare setting, suggesting that patients are, overall, facing shared challenges and opportunities in SDM, that are mostly generalizable and irrespective of variabilities in decisional setting or patient group. We uncovered new trends such as patients' growing openness to assertiveness and the involvement of significant others, and highlighted some culture-based nuances, compared to earlier literature. PRACTICE IMPLICATIONS:These new insights need to be integrated in SDM strategies so that they may serve the ethical imperative of a greater equality and inclusion of diverse patient groups in different SDM settings.
Background Shared decision making (SDM) has been presented as the preferred approach for decisions where there is more than one acceptable option and has been identified a priority feature of high-quality patient-centered care. Considering the foundation of trust between general practitioners (GPs) and patients and the variety of diseases in primary care, the primary care context can be viewed as roots of SDM. GPs are requesting training programs to improve their SDM skills leading to a more patient-centered care approach. Because of the high number of training programs available, it is important to overview these training interventions specifically for primary care and to explore how these training programs are evaluated.Methods This review was reported in accordance with the PRISMA guideline. Eight different databases were used in December 2022 and updated in September 2023. Risk of bias was assessed using ICROMS. Training effectiveness was analyzed using the Kirkpatrick evaluation model and categorized according to training format (online, live or blended learning).Results We identified 29 different SDM training programs for GPs. SDM training has a moderate impact on patient (SMD 0.53 95% CI 0.15-0.90) and observer reported SDM skills (SMD 0.59 95%CI 0.21-0.97). For blended training programs, we found a high impact for quality of life (SMD 1.20 95% CI -0.38-2.78) and patient reported SDM skills (SMD 2.89 95%CI -0.55-6.32).Conclusion SDM training improves patient and observer reported SDM skills in GPs. Blended learning as learning format for SDM appears to show better effects on learning outcomes than online or live learning formats. This suggests that teaching facilities designing SDM training may want to prioritize blended learning formats. More homogeneity in SDM measurement scales and evaluation approaches and direct comparisons of different types of educational formats are needed to develop the most appropriate and effective SDM training format.Trial registration PROSPERO: A systematic review of shared-decision making training programs in a primary care setting. PROSPERO 2023 CRD42023393385 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023393385.
BACKGROUND:COVID-19 may initially manifest as flu-like symptoms. As such, general practitioners (GPs) will likely to play an important role in monitoring the pandemic through syndromic surveillance.OBJECTIVES:To present a COVID-19 syndromic surveillance tool in Belgian general practices.METHODS:We performed a nationwide observational prospective study in Belgian general practices. The surveillance tool extracted the daily entries of diagnostic codes for COVID-19 and associated conditions (suspected or confirmed COVID-19, acute respiratory infection and influenza-like illness) from electronic medical records. We calculated the 7-day rolling average for these diagnoses and compared them with data from two other Belgian population-based sources (laboratory-confirmed new COVID-19 cases and hospital admissions for COVID-19), using time series analysis. We also collected data from users and stakeholders about the syndromic surveillance tool and performed a thematic analysis.RESULTS:4773 out of 11,935 practising GPs in Belgium participated in the study. The curve of contacts for suspected COVID-19 followed a similar trend compared with the curves of the official data sources: laboratory-confirmed COVID-19 cases and hospital admissions but with a 10-day delay for the latter. Data were quickly available and useful for decision making, but some technical and methodological components can be improved, such as a greater standardisation between EMR software developers.CONCLUSION:The syndromic surveillance tool for COVID-19 in primary care provides rapidly available data useful in all phases of the COVID-19 pandemic to support data-driven decision-making. Potential enhancements were identified for a prospective surveillance tool.
Background The current hepatitis B (HBV) and hepatitis C virus (HCV) screening practices may fail to detect many infected patients who could benefit from new therapeutic agents to limit progression to cirrhosis and hepatocellular carcinoma. Objectives This study assessed the test positivity rate and cascade of care of viral hepatitis patients in primary care in a low endemic region as well as the testing policy of abnormal alanine aminotransferase (ALT) level. Methods This is a retrospective clinical audit among primary health care practices in Flanders, Belgium, assessing patients with an active medical file between 2019 and 2021. Results A total of 84/89 (94.4%) primary health care practices participated representing 621,573 patients of which 1069 patients (0.17%) were registered as having viral hepatitis, not further specified. Detailed information was available from 38 practices representing 243,723/621,573 (39.2%) patients of which 169 (0.07%) were HBsAg positive and 99 (0.04%) anti-HCV positive. A total of 96/134(71.6%) chronic HBV-infected and 31/77(40.3%) chronic HCV-infected patients were referred to a hepatologist. A total of 30,573/621,573(4.9%) patients had an abnormal ALT level, and by at random selection, more detailed information was obtained on 211 patients. Information on high-risk groups was missing in up to 60%. In patients with abnormal ALT level, HBsAg and anti-HCV testing were conducted in 37/211(17.5%) and 25/211(11.8%), respectively. Conclusion In a low endemic region, the testing rate and cascade of care of HBV and HCV-infected patients can be improved in primary care, especially in high-risk groups and patients with abnormal ALT levels.
Objectives To explore the educational needs of physicians and residents regarding shared decision making (SDM). Methods We conducted eight focus groups with 12 general practitioners (GPs), 14 hospital specialists, 12 hospital specialist residents and 13 GP residents in Belgium. We used thematic analysis to guide data analysis. Results We identified five educational needs: (1) the need for a clear understanding of the definition of SDM and its scope; (2) how to deal with a changing professional identity; (3) acquisition of skills to perform SDM; (4) the need for reflective practice in a supportive environment; and (5) sustainable and longitudinal integration in education. Conclusions This is the first focus group study emphasizing dealing with a changing professional identity as an educational need, besides the need for SDM-related knowledge and skills. Physicians stated that implementing spiral learning is needed at all stages of medical training, aimed at all specialties to foster interprofessional collaboration. Practice implications Our findings can support development of future educational SDM interventions, integrating both competence development and professional identity formation. We provide practical recommendations on didactic formats and strategies, hoping to finally reach better implementation of SDM in daily practice.
Background Older people want to age in place. Despite advancing functional limitations and their desire of aging in place, they are not always faithful to therapy that maintains independence and promotes safety. Occupational therapists can facilitate aging in place. Occupational therapy is defined as the therapeutic use of everyday life occupations with persons, groups, or populations for the purpose of enhancing or enabling participation. Aim To describe the content a high-adherence-to-therapy and evidence-based occupational therapy intervention to optimize functional performance and social participation of home-based physically frail older adults and wellbeing of their informal caregiver, and the research activities undertaken to design this intervention. Methods A roadmap was created to develop the occupational therapy intervention. This roadmap is based on the Medical Research Council (MRC) framework and is supplemented with elements of the Intervention Mapping approach. The TIDieR checklist is applied to describe the intervention in detail. A systematic review and two qualitative studies substantiated the content of the intervention scientifically. Results The application of the first two phases of the MRC framework resulted in the ProMOTE intervention (Promoting Meaningful activities by Occupational Therapy in Elderly). The ProMOTE intervention is a high-adherence-to-therapy occupational therapy intervention that consists of six steps and describes in detail the evidence-based components that are required to obtain an operational intervention for occupational therapy practice. Conclusion This study transparently reflects on the process of a high-quality occupational therapy intervention to optimize the functional performance and social participation of the home-based physically frail older adult and describes the ProMOTE intervention in detail. The ProMOTE intervention contributes to safely aging in place and to maintaining social participation. The designed intervention goes beyond a description of the ‘what’. The added value lies in the interweaving of the ‘why’ and ‘how’. By describing the ‘how’, our study makes the concept of ‘therapeutic use-of-self’ operational throughout the six steps of the occupational therapy intervention. A further rigorous study of the effect of the ProMOTE intervention on adherence, functional performance and social participation is recommended based to facilitate the implementation of this intervention on a national level in Belgium.
CLINICAL QUESTION:What is the impact of sodium-glucose cotransporter-2 (SGLT-2) inhibitors on survival and on cardiovascular and kidneyoutcomes for adults living with chronic kidney disease (CKD)? CURRENT PRACTICE:Few therapies slow kidney disease progression and improve long term prognosis for adults living with CKD. SGLT-2 inhibitors have demonstrated cardiovascular and kidney benefits in adults with CKD with and without type 2 diabetes. Existing guidance for SGLT-2 inhibitors does not account for the totality of current best evidence for adults with CKD and does not provide fully stratified treatment effects and recommendations across all risk groups based on risk of CKD progression and complications. RECOMMENDATIONS:The guideline panel considered evidence regarding benefits and harms of SGLT-2 inhibitor therapy for adults with CKD over a five year period, along with contextual factors, and provided the following recommendations:1. For adults at low risk of CKD progression and complications, we suggest administering SGLT-2 inhibitors (weak recommendation in favour)2. For adults at moderate risk of CKD progression and complications, we suggest administering SGLT-2 inhibitors (weak recommendation in favour)3. For adults at high risk of CKD progression and complications, we recommend administering SGLT-2 inhibitors (strong recommendation in favour)4. For adults at very high risk of CKD progression and complications, we recommend administering SGLT-2 inhibitors (strong recommendation in favour).Recommendations are applicable to all adults with CKD, irrespective of type 2 diabetes status. HOW THIS GUIDELINE WAS CREATED:An international panel including patients, clinicians, and methodologists produced these recommendations following standards for trustworthy guidelines and using the GRADE approach. The panel identified typical risk strata of adults with CKD (from low to very high risk of CKD progression and related complications) using the classification system developed by Kidney Disease Improving Global Outcomes (KDIGO), and applied an individual patient perspective in moving from evidence to recommendations. Effects of SGLT-2 inhibitors were interpreted in absolute terms applicable to different risk strata with varying baseline risks for outcomes of benefit over a five year period. The panel explicitly considered the balance of benefits, harms, and burdens of starting an SGLT-2 inhibitor, incorporating the values and preferences of adults with different risk profiles. Interactive evidence summaries and decision aids accompany multilayered recommendations, developed in an online authoring and publication platform (www.magicapp.org) that allows reuse and adaptation. THE EVIDENCE:A linked systematic review and pairwise meta-analysis (13 trials including 29 614 participants) of benefits and harms associated with SGLT-2 inhibitors in adults with CKD with or without type 2 diabetes informed guidance. Among individuals at very high risk of CKD progression and complications, moderate to high certainty evidence shows SGLT-2 inhibitors (relative to placebo or standard care without SGLT-2 inhibitors) decrease all-cause and cardiovascular mortality, hospitalisation for heart failure, kidney failure, non-fatal myocardial infarction, and non-fatal stroke. Among individuals at high risk, moderate to high certainty evidence shows SGLT-2 inhibitors result in similar benefits across outcomes except demonstrating little or no effect on hospitalisation for heart failure and kidney failure. Among individuals at moderate and low risk, moderate to high certainty evidence shows SGLT-2 inhibitors probably reduce all-cause mortality and non-fatal stroke, with little or no effect for other outcomes of benefit. Risk-stratified estimates were unavailable for outcomes of harm; the panel therefore considered absolute effects summarised across risk strata. SGLT-2 inhibitors are associated with little or no effect on acute kidney injury requiring dialysis, bone fractures, lower limb amputations, ketoacidosis, genital infections, or symptomatic hypovolaemia, although a residual possibility of harms at the individual patient level remains. UNDERSTANDING THE RECOMMENDATION:In order to apply recommendations, clinicians must appropriately identify adults with CKD, consider the underlying aetiology, and risk stratify them based on glomerular filtration rate (estimated or measured) and degree of albuminuria. In addition to classifying individuals into risk strata, further estimation of a given patient's risk based on the extent of their kidney disease and other comorbidities may be warranted to inform individual-level decisions and shared decision making. Available risk calculators may help estimate a given patient's risk of CKD progression and complications.
OBJECTIVES:To evaluate and improve "Making Alternative Treatment Choices Intuitive and Trustworthy" (MATCH-IT)-a digital, interactive decision support tool displaying structured evidence summaries for multiple comparisons-to help physicians interpret and apply evidence from network meta-analysis (NMA) for their clinical decision-making. STUDY DESIGN AND SETTING:We conducted a qualitative user testing study, applying principles from user-centered design in an iterative development process. We recruited a convenience sample of practicing physicians in Norway, Belgium, and Canada, and asked them to interpret structured evidence summaries for multiple comparisons-linked to clinical guideline recommendations-displayed in MATCH-IT. User testing included (a) introduction of a clinical scenario, (b) a think-aloud session with participant-tool interaction, and (c) a semistructured interview. We video recorded, transcribed, and analyzed user tests using directed content analysis. The results informed new updates in MATCH-IT. RESULTS:Distributed across 5 development cycles we tested MATCH-IT with 26 physicians. Of these, 24 (94%) reported either no or sparse prior experience with interpretation of NMA. Physicians perceived MATCH-IT as easy to interpret and navigate, and appreciated its ability to provide an overview of the evidence. Visualization of effects in pictograms and inclusion of information on burden of treatment ("practical issues") were highlighted as potentially useful features in interacting with patients. We also identified problems, including undiscovered functionalities (drag and drop), suboptimal tutorial, and cumbersome navigation of the tool. In addition, physicians wanted definition/explanation of key terms (eg, outcomes and "certainty"), and there were concerns that overwhelming evidence from a large NMA would complicate applicability to clinical practice. This led to several updates with development of a new start page, tutorial, updated user interface for more efficient maneuvering, solutions to display definition of key terms and a "frequently asked questions" section. To facilitate interpretation of large networks, we improved categorization of results using color coding and added filtering functionality. These modifications allowed physicians to focus on interventions of interest and reduce information overload. CONCLUSION:This study provides proof of concept that physicians can use MATCH-IT to understand NMA evidence. Key features of MATCH-IT in a clinical context include providing an overview of the evidence, visualization of effects, and the display of information on burden of treatments. However, unfamiliarity with the Grading of Recommendations Assessment, Development and Evaluation concepts, time constraints, and accessibility at the point of care may be challenges for use. To what extent our results are transferable to real-world clinical contexts remains to be explored.
Wastewater surveillance plays an important role in the management of the coronavirus disease 2019 (COVID-19) pandemic all over the world. Using different wastewater collection points in Leuven, we wanted to investigate the use of wastewater surveillance as an early warning system for an uprise of infections and as a tool to follow the circulation of specific variants of concern (VOCs) in particular geographic areas. Wastewater samples were collected from local neighborhood sewers and from a large regional wastewater treatment plant (WWTP) in the area of Leuven, Belgium. After virus concentration, severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA was quantified by real-time quantitative polymerase chain reaction (RT-qPCR) and normalized with the human fecal indicator pepper mild mottle virus (PMMoV). A combination of multiplex RT-qPCR assays was used to detect signature mutations of circulating VOCs. Fecal virus shedding of SARS-CoV-2 variants was measured in feces samples of hospitalized patients. In two residential sampling sites, a rise in wastewater SARS-CoV-2 concentration preceded peaks in positive cases. In the WWTP, viral load peaks were seen concomitant with the consecutive waves of positive cases caused by the original Wuhan SARS-CoV-2 strain and subsequent VOCs. During the Omicron BA.1 wave, the wastewater viral load increased to a lesser degree, even after normalization of SARS-CoV-2 concentration using PMMoV. This might be attributable to a lower level of fecal excretion of this variant. Circulation of SARS-CoV-2 VOCs Alpha, Delta, Omicron BA1/BA.2, and BA.4/BA.5 could be detected based on the presence of specific key mutations. The shift in variants was noticeable in the wastewater, with key mutations of two different variants being present simultaneously during the transition period. Wastewater-based surveillance is a sensitive tool to monitor SARS-CoV-2 circulation levels and VOCs in larger regions. In times of reduced test capacity, this can prove to be highly valuable. Differences in excretion levels of various SARS-CoV-2 variants should however be taken into account when using wastewater surveillance to monitor SARS-CoV-2 circulation levels in the population.
Objectives The latest international guideline recommended the add-on therapy of ezetimibe and PCSK9 inhibitors in selected people for the secondary prevention of cardiovascular diseases (CVDs). However, it remains unclear whether these regimens fit the Chinese healthcare system economically.Methods Based on the Chinese context, this simulation study evaluated four therapeutic strategies including the high-dose statin-only group, ezetimibe plus statin group, PCSK9 inhibitors plus statin group, and PCSK9 inhibitors plus ezetimibe plus statin group. The team developed a Markov model to estimate the incremental cost-effectiveness ratio (ICER). With each 1-yr cycle, the simulation subjects could have nonfatal cardiovascular events (stroke and/or myocardial infarction) or death (vascular or nonvascular death event) with a follow-up duration of 20 yr. Cardiovascular risk reduction was gathered from a network meta-analysis, and cost and utility data were gathered from hospital databases and published research.Results For Chinese adults receiving high-dose statins for secondary prevention of CVDs, the ICER was US$68,910 per quality-adjusted life year (QALY) for adding PCSK9 inhibitors, US$20,242 per QALY for adding ezetimibe, US$51,552 per QALY for adding both drugs. Given a threshold of US$37,655 (three times of Chinese GDP), the probability of cost-effectiveness is 2.9 percent for adding PCSK9 inhibitors, 53.1 percent for adding ezetimibe, and 16.8 percent for adding both drugs. To meet the cost-effectiveness, an acquisition price reduction of PCSK9 inhibitors of 33.6 percent is necessary.Conclusion In Chinese adults receiving high-dose statins for the secondary prevention of CVDs, adding ezetimibe is cost-effective compared to adding PCSK9 inhibitors and adding both drugs.