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At least 217 records · Page 12Linked to original sources

PubMed2026

Weight regain following discontinuation of glucagon-like peptide-1 receptor agonists in adults who are overweight or obese: a systematic review and meta-analysis.

OBJECTIVE: This study aims to explore the effects of glucagon-like peptide-1 receptor agonists (GLP-1RAs) on weight changes and the occurrence of adverse reactions in overweight or obese adults after drug withdrawal. METHODS: Computerized searches were conducted in evidence-based databases such as PubMed, Embase, Cochrane Library and Scopus. The search period was from the establishment of the database to December 2025. Collect randomised controlled trials (RCTs) and controlled trials on GLP-1RAs, including tirzepatide, semaglutide, liraglutide, and dulaglutide, for the treatment of overweight or obese adult patients. The risk of bias in the included studies was assessed using the Cochrane Risk of Bias V2.0 tool provided by the Cochrane Collaboration, and meta-analysis was performed using the R programming language. RESULTS: A total of 699 studies were initially retrieved. Eventually, six studies involving 8,993 patients were included in the quantitative analysis, comprising 5,553 patients in the discontinuation group and 3,440 in the continued treatment group. The results of the meta-analysis showed that, compared with the continued treatment group, the weight difference in the discontinuation group was mean difference (MD) = 17.90%, 95% confidence interval (CI) [14.11-21.69], P < 0.0001. It can be seen that there was a significant rebound in weight after drug withdrawal, and there was statistical heterogeneity among the studies (P = 0.0082). Subgroup analysis further revealed that the weight rebound amplitude after discontinuation of tirzepatide was significantly higher than that of semaglutide. This result suggests that the differences in the mechanism of action of different GLP-1RAs may be the reason for the differences in weight changes after discontinuation. In addition, the percentage difference in body weight between after and before drug withdrawal was MD = 9.11%, 95% CI [7.91-10.30], P < 0.0001, further verifying the trend of weight rebound after drug withdrawal. The summary of adverse reaction reports analyzed and studied indicates that after drug withdrawal, the overall adverse reactions of patients decreased, gastrointestinal adverse reactions decreased, and the incidence of cardiovascular events was not affected by drug withdrawal. CONCLUSION: There is a significant weight rebound phenomenon after discontinuation of GLP-1RAs, and the rebound magnitudes vary among different types of drugs. At the same time, there is a risk of adverse reactions during the use of such drugs.

Humans↗

PubMed1995

Hormone replacement therapy and breast cancer: what are the facts?

Selective quotation in the popular press of studies showing a potential association between hormone replacement therapy (HRT) and breast cancer has fuelled women's concern. However, the increase in detected breast cancer among long term HRT users that was seen in some studies is compatible with surveillance bias and confounding caused by increased risk factors among HRT users (e.g., higher socioeconomic class, alcohol intake and body mass index). Until adequate data are available from randomised controlled trials, the evidence-based conclusion is that HRT has no effect on breast cancer rates. HRT may reduce mortality and morbidity from other diseases and the overall risk-benefit ratio should be considered for each woman.

Adult↗

PubMed1994

Periodic health examination, 1994 update: 3. Primary and secondary prevention of neural tube defects. Canadian Task Force on the Periodic Health Examination.

OBJECTIVE: To make recommendations on nutritional interventions and screening manoeuvres to prevent the birth of infants with neural tube defects (NTDs). OPTIONS: Folic acid consumption through diet or supplementation in women at low risk and at high risk of having a fetus with an NTD, and maternal serum alpha-fetoprotein (MSAFP) screening in low-risk pregnancies. OUTCOMES: A reduction in the incidence rate of NTDs and potentially harmful effects of false-positive results of screening tests (i.e., abortion of a normal fetus). EVIDENCE: A MEDLINE search with the use of medical subject headings "neural tube defects," "prenatal diagnosis" and "prevention and control" identified 103 original articles published between January 1979 and March 1993. Two reviewers extracted the data by applying the rules of evidence developed by the Canadian Task Force on the Periodic Health Examination. VALUES: The task force's evidence-based methods and values were used; high value was placed on prevention of NTDs and on limitation of the harmful effects of a pregnancy involving a fetus with an NTD. BENEFITS, HARMS AND COSTS: Evidence suggests that folic acid supplementation can decrease the incidence rate of NTDs in low-risk pregnancies by 40% to 60% with no adverse effects. MSAFP screening between the 16th and 18th weeks of gestation can reach a sensitivity of 83% and a specificity of 98% when it is used as part of an organized program. The effect of screening on the incidence rate of NTDs depends on whether affected fetuses are aborted. RECOMMENDATIONS: All women of childbearing age should be advised to increase their consumption of folic acid through diet or supplementation to 0.4 mg/d beginning 1 month before pregnancy and ending at the start of the second trimester. MSAFP screening is recommended in low-risk pregnancies only when it is part of a screening program that includes access to all necessary diagnostic services. High-risk women should be referred to genetic counselling before they plan a pregnancy. VALIDATION: These recommendations are comparable to the current recommendations of the US Centers for Disease Control and Prevention, the Society of Obstetricians and Gynaecologists of Canada, the Canadian Laboratory Centre for Disease Control and the Canadian College of Medical Geneticists, and they were validated through external review. SPONSOR: These guidelines were developed and endorsed by the Canadian task force, which funded by Health Canada.

Canada↗

PubMed1995

Inpatient general medicine is evidence based. A-Team, Nuffield Department of Clinical Medicine.

For many years clinicians have had to cope with the accusation that only 10-20% of the treatments they provide have any scientific foundation. Their interventions, in other words, are seldom "evidence based". Is the profession guilty as charged? In April, 1995, a general medical team at a university-affiliated district hospital in Oxford, UK, studied the treatments given to all 109 patients managed during that month on whom a diagnosis had been reached. Medical sources (including databases) were then searched for randomised controlled trial (RCT) evidence that the treatments were effective. The 109 primary treatments were then classified: 82% were evidence based (ie, there was RCT support [53%] or unanimity on the team about the existence of convincing non-experimental evidence [29%]). This study, which needs to be repeated in other clinical settings and for other disciplines, suggests that earlier pessimism over the extent to which evidence-based medicine is already practised is misplaced.

Clinical Medicine↗

PubMed1995

Importance of and satisfaction with work and professional interpersonal issues: a survey of physicians practicing general internal medicine in Ontario.

OBJECTIVES: To explore the importance of and satisfaction with clinical responsibilities, teaching, research and interpersonal issues among general internists; to understand the barriers to satisfaction in these domains and the usefulness of potential solutions to these problems. DESIGN: Cross-sectional survey conducted from November 1992 to June 1994. SETTING: Ontario. PARTICIPANTS: General internists who were fellows of the Royal College of Physicians and Surgeons of Canada and members of the Ontario Medical Association. Of 1192 physicians, 1007 (84.5%) returned a completed questionnaire; only the 199 who devoted at least 50% of their time to the practice of general internal medicine were included in this analysis. RESULTS: The respondents were satisfied with their primary role as clinicians dealing with complex, undifferentiated problems caring for the total patient and providing consultation. Guidelines for the referral of patients to general internists, computerization of test results, recruitment of general internal medicine fellows and more confidence in the future of general internal medicine were some of the solutions considered likely to increase professional satisfaction. The respondents involved in teaching suggested additional solutions, such as an opportunity to improve their teaching and evidence-based medicine skills and a greater recognition for their teaching efforts. Few of the general internists conducted research, barriers included lack of personal and project funding, and pressure to generate clinical earnings. In the domain of professional interpersonal issues, women were significantly more likely than men to rate having a mentor, peer support groups, ongoing career counselling, promotion and tenure guidelines for parental leave, availability of on-site day care, addressing gender discrimination and adoption of gender-neutral language as likely to improve the work environment. CONCLUSIONS: The primary role of general internists is that of patient-centred clinician. Our findings suggest that general internists want to take responsibility for revitalizing this discipline. The potential solutions generated in this survey may help to promote action that will improve professional satisfaction in the area of clinical responsibilities, teaching, research and interpersonal issues.

Adult↗

PubMed1995

Periodic health examination, 1995 update: 2. Prevention of dental caries. The Canadian Task Force on the Periodic Health Examination.

OBJECTIVE: To make recommendations, based on current evidence, for practising physicians and dentists on interventions for the prevention of dental caries in their patients. OPTIONS: Systemic fluoride administration, professionally administered fluoride, use of fluoride mouth rinses, fissure sealants, oral-hygiene practices, dietary practices, identification of groups at a high risk of dental caries, and early diagnosis and treatment. OUTCOMES: Reduced prevalence of dental caries and fluorosis, longer retention of teeth and lower treatment costs. EVIDENCE: Several MEDLINE searches were conducted for articles published from January 1980 to December 1992, including relevant review articles. VALUES: Relevant clinical findings were evaluated and categorized with the use of the evidence-based methods and values of the Canadian Task Force on the Periodic Health Examination. Recommendations were developed for each method of caries prevention, with reduced incidence of dental caries and improved prevalence of caries-free teeth given high values. BENEFITS, HARMS AND COSTS: The potential benefits of these measures in the long-term are a lower incidence of tooth decay, longer retention of teeth and prevention of fluorosis. The cost saving can be considerable for patients and insurers; however, implementation of some recommendations will be difficult, since the traditional preventive practices of dentists and dental hygienists are not easily changed. RECOMMENDATIONS: There is good evidence that the following manoeuvres are effective in preventing dental caries: use of dentifrices containing fluoride, fluoridation of drinking water, fluoride supplements for patients in areas where there is a low level (0.3 ppm or less) of fluoride in the drinking water, professionally applied topical fluoride and the use of fluoride mouth rinses for patients with very active decay or at a high risk of dental caries and selective use of professionally applied fissure sealants on permanent molar teeth. There is poor evidence that the following manoeuvres are effective in preventing dental caries: professionally applied topical fluoride and the use of fluoride mouth rinses for patients with a low risk of caries, toothbrushing (without a dentifrice containing fluoride) and flossing, cleaning of teeth by a dentist or dental hygienist before topical application of fluoride or at a dental visit and dietary counselling for the general population. There is good evidence to recommend against the use of over-the-counter fluoride mouth rinses by the general population. VALIDATION: These guidelines are compatible with those of the US Preventive Services Task Force. SPONSOR: These guidelines were developed and endorsed by the task force, which is funded by Health Canada. Major funding was provided by the Faculty of Dentistry of the University of Toronto, Toronto and the Faculty of Dentistry of Dalhousie University, Halifax.

Canada↗

PubMed1995

Research, practice and the Cochrane Collaboration.

The Cochrane Collaboration coordinates the efforts of health care professionals and researchers around the world to prepare, maintain and disseminate systematic reviews of health care research. In carrying out the first two tasks the collaboration employs a rigorous method for analysing the findings of randomized controlled trials; this method was developed in the 1980s and has undergone continual improvement since then. The collaborators believe their work will consolidate and make available the accumulated results of sound research assessing the effectiveness of health care interventions and thus steer health care professionals and consumers toward the right treatments and help guide research into new therapies. Since the collaboration began, in 1993, Cochrane centres have been set up in the British Isles, Canada, Denmark, Italy, the Netherlands and the United States, and many new Cochrane review groups have been registered. Canadian scientists have played an important role in the collaboration. They have prepared and maintained systematic reviews, hosted the collaboration's second annual colloquium and are currently in the vanguard of efforts to facilitate the dissemination of collaboration documents. Although the collaboration uses new modes of communication it has not abandoned traditional ones. Nor has it underestimated the work that remains to be done to bring review findings to the attention of health care providers. Early indications suggest, however, that the collaboration's basic message about the importance of evidence-based practice is getting through.

Canada↗

PubMed1995

Primary and secondary prevention services in clinical practice. Twenty years' experience in development, implementation, and evaluation.

This article reviews lessons from 20 years of experience in development and provision of clinical preventive services at Group Health Cooperative of Puget Sound, a large health maintenance organization. Critical factors for enhancing service include the use of a population-based epidemiologic viewpoint coupled with specific evidence-based criteria to examine issues; involvement of practitioners in the process; a systems approach to implementation focused on predisposing factors of the practitioners and enabling factors in the practice, organizational, and community environments; feedback of program outcomes; and the use of automated clinical information systems. Outcome results from our clinical prevention efforts include a 32% decrease in late-stage breast cancer (1989 to 1990); 89% of 2-year-old children with complete immunizations (1994); decrease in adult smokers from 25% to 17% (1985 to 1994); and an increase in bicycle safety helmet use among children from 4% to 48% along with a 67% decrease in bicycle-related head injuries (1987 to 1992). Systematic population-based approaches to the development and provision of clinical preventive services targeting the one-to-one level of primary care and multiple infrastructure levels of care are forging a synthesis of clinical medicine and public health approaches. This approach will become pervasive as clinical information systems improve, risk information is captured routinely, and practitioners gain skills in the art of patient risk behavior change and population-based care.

Breast Neoplasms↗

PubMed1995

From premise to principle: the impact of the gut hypothesis on the practice of critical care surgery.

Clinical decision making is ideally founded on evidence of efficacy derived from well-designed randomized clinical trials. In reality, such evidence is rarely available to the surgeon caring for the patient with multiple trauma or who is critically ill, and complex management decisions must be made by less rigorous, more subjective means. An understanding of the normal biologic state and its alterations during disease has long been a fundamental component of medical education. Although such an understanding does not provide practitioners with grounds for assuming therapeutic efficacy in a particular patient, it does shape their perception of the important principles that guide the decision-making process. In contrast to evidence-based medicine--the making of therapeutic decisions through the systematic synthesis of results of clinical trials--a knowledge of pathobiology supports a complementary approach that the authors term "inference-based medicine"--the use of insights from studies in basic biology to establish principles that guide the practitioners' approach to groups of patients. The impact of a relatively new area of biologic investigation into the effects of the gut flora on systemic homeostasis, and the perturbations of this process in trauma and critical illness are reviewed. Re-emergence of the "gut hypothesis" has had a relatively modest effect if measured by the introduction of promising new forms of specific therapy. However, these investigations have resulted in a fundamental paradigm shift in two important areas in the practice of trauma and critical care surgery: the use of antimicrobial agents and the route of nutritional support.

Animals↗

PubMed1995

Periodic health examination, 1995 update: 3. Screening for visual problems among elderly patients. Canadian Task Force on the Periodic Health Examination.

OBJECTIVE: To provide recommendations to family physicians for screening elderly patients (over 65 years of age) for visual impairment and its common clinical causes. OPTIONS: Visual acuity screening with Snellen sight chart, funduscopy, retinal photography, tonometry and perimetry. OUTCOMES: Delay or prevention of visual deterioration or blindness. EVIDENCE: A MEDLINE search for relevant articles published between January 1986 and December 1993 was undertaken, the bibliographies of the articles were scrutinized for additional articles, and experts were consulted. The highest available level of evidence was used in making recommendations. VALUES: The evidence-based methods and values of the Canadian Task Force on the Periodic Health Examination were used. Preservation of vision was given the highest value in accordance with other guidelines regarding eyesight. BENEFITS, HARMS AND COSTS: Potential benefits are to maintain or improve visual acuity. Potential for harm to patients is minimal. Limited data are available on costs. RECOMMENDATIONS: There is fair evidence to include in the periodic health examination visual acuity testing with a Snellen sight chart and funduscopy or retinal photography in elderly patients with diabetes of at least 5 years' duration (grade B recommendation). The place of funduscopy in the detection of age-related macular degeneration and glaucomatous changes is controversial. For patients at high risk for glaucoma (positive family history, black race, severe myopia or diabetes) it would be prudent to have a periodic assessment by an ophthalmologist. VALIDATION: Recommendations differ from those of the American Academy of Ophthalmology and the American Optometric Association. Recommendations for glaucoma screening are similar to those of the US Preventive Services Task Force. Present recommendations have been reviewed by experts in ophthalmology and optometry. SPONSOR: These guidelines were developed and endorsed by the task force, which is funded by Health Canada and the National Health Research and Development Program. The principal author (C.P.) was supported in part by the Educational Centre for Aging and Health, McMaster University, Hamilton, Ont.

Aged↗

PubMed1995

Can practice patterns and outcomes be successfully altered? Examples from cardiovascular medicine. The Clinical Quality Improvement Network (CQIN) Investigators.

OBJECTIVE: To offer an attributive opinion of recent improvements in acute myocardial infarction (AMI) practice patterns and patient outcomes in the culture of an active health care research program. DATA SOURCES: Review of original clinical data from five sequential, consecutively enrolled, AMI patient cohorts at the University of Alberta Hospitals from 1987-93. DATA SYNTHESIS: Early cohorts had low use of trial-proven efficacious therapies for AMI, particularly among high risk older and female patients. Over time, there were continuous and marked increases in the use of efficacious therapies and decreased use of nonefficacious therapies, with a parallel decrease in mortality among high risk patients. CONCLUSIONS: In a large tertiary care hospital between 1987 and 1993 the use of evidence-based AMI therapy and survival in high risk patients significantly increased. The continuity and large size of these improvements in AMI practice patterns, compared with similar populations reported in the contemporary literature, suggest it is unlikely they were due to chance. Rather, intercurrent repeated measurement and reporting of key health care performance indicators, and initiation of explicit critical path AMI practice guidelines provide a more likely explanation. Future studies by a network of community and university investigators will test whether these findings are true for a broad AMI population and whether similar practice definition and improvement tools are effective for other cardiac problems, including the management of congestive heart failure.

Adult↗

PubMed1995

Improving outcomes in diabetes: a review of the outpatient care of NIDDM patients.

This article is a critical review of the recent medical literature on the outpatient care of patients with non-insulin-dependent diabetes mellitus (type II). The 1989 consensus statement of the American Diabetes Association, "Standards of Medical Care for Patients with Diabetes Mellitus," has been selected as an initial point of departure. The author's goal is to present an evidence-based approach to the outpatient care of patients with type II diabetes in a way that is practical, strategically focused, and consistent with the basic philosophy of family practice. This article sets forth a detailed flow sheet for the implementation of this approach by the nurse and physician working as a team.

Diabetes Mellitus, Type 2↗

PubMed1994

Guidelines for clinical preventive services. Essential for nurse practitioners in practice, education, and research.

Guidelines for clinical preventive services, including counseling, screening, and immunizations, are important to nurse practitioner practice, education, and research. Delivery of clinical preventive services can be improved by the use of evidence-based guidelines, which provide recommendations on what services should be provided and who should receive them. Development of guidelines by the U.S. Preventive Services Task Force is discussed, as well as principal findings that evolved from their deliberations. The authors provide a rationale and options for the development of nursing guidelines for clinical preventive services. Implementation of guidelines can be facilitated by use of the "Put Prevention Into Practice" materials.

Delivery of Health Care↗

PubMed2026

What's the meta now? More updates on the problems with systematic reviews.

BACKGROUND: Systematic reviews are intended to provide trustworthy evidence synthesis, yet previous iterations of this living review have identified numerous recurring problems in their conduct and reporting. This article presents the third version and second update of the living systematic review examining issues raised across the academic literature. METHODS: Using consistent eligibility criteria and methods from earlier versions, literature searches were updated to May 2025. Eligible meta-research and editorial articles describing problems with systematic reviews were analyzed to identify emerging themes. Additionally, four basic indicators of methodological quality of the included meta-research were presented across review versions. RESULTS: The update included 209 additional articles. Critically low methodological quality and absence of protocols remained among the most frequently reported issues in systematic reviews across disciplines and journals but notably in evidence underpinning clinical practice guidelines. Spin in abstracts and conflicts of interest continued to be common. Apparent improvements in reporting quality were inconsistent, with modest gains in some full-text reporting but persistent deficiencies in abstracts. Authorship diversity of systematic reviews improved in gender representation but remained geographically concentrated in high-income countries, and primary research included in reviews similarly lacked global representativeness. The issue of misalignment between systematic review evidence bases and global burden of disease bring the total number of problems with systematic reviews to 69. Emerging use of automation and artificial intelligence was variably reported. Descriptive comparison of meta-research articles over the three versions of this living review suggests a greater proportion meeting basic quality indicators in more recent updates. CONCLUSION: Across successive updates, problems with systematic reviews remain widespread and consistent rather than isolated. Incremental reporting improvements coexist with persistent concerns about transparency, bias, and representativeness. Future efforts should prioritize evaluating interventions and aligning research incentives to support genuinely trustworthy evidence synthesis.

Humans↗

PubMed2026

Interventions with a significant mortality difference in acute respiratory distress syndrome: A systematic review and comparison with Guidelines.

INTRODUCTION: Acute respiratory distress syndrome (ARDS) has a high mortality rate. European Society of Intensive Care Medicine (ESICM) and American Thoracic Society (ATS) Guidelines are the worldwide reference for clinicians in management of ARDS. Mortality represents one of the most important outcomes in intensive care practice and randomized controlled trials (RCTs) the highest level of evidence. We compared Guidelines recommendations with RCT results to highlight differences and find potential new therapeutic opportunities. METHODS: We performed a systematic review of all RCTs reporting a statistically significant mortality difference in ARDS and a subsequent comparison with ESICM and ATS Guidelines recommendations. RESULTS: We identified 33 RCTs and 23 interventions with mortality difference in ARDS patients. Seven interventions relate to invasive ventilation strategies, two to noninvasive ventilation strategies, one to extracorporeal membrane oxygenation (ECMO), 12 to drugs and one to nutritional support. In 25/33 (76%) RCTs the intervention was associated with mortality reduction and in 8/33 with mortality increase (24%). Multicenter studies were 24/33 (73%) while blinding was adopted in 19/33 (58%) studies. Guidelines recommendations supported by RCTs with mortality impact include: the use of low tidal volume ventilation, prone positioning, venovenous ECMO, steroids and the avoidance of high frequency oscillatory ventilation. Eight of the interventions identified were not mentioned by Guidelines but demonstrated reduced mortality, and five further interventions demonstrated increased mortality. CONCLUSIONS: This systematic review highlights potential gaps between RCTs results and Guidelines that could be used to plan future research or highlight topics to be discussed in future Guidelines.

Humans↗

PubMed2026

Assessment of blinding in pharmacotherapy and noninvasive neuromodulation randomized controlled trials for neuropathic pain in adults.

In randomized controlled trials (RCTs), study participants and research personnel are often blinded to minimize biases related to knowing treatment allocation. To determine if blinding was effective, participants may be asked which treatment they believe they received ("treatment guess"). This descriptive review characterized blinding assessment (BA) reporting in pharmacotherapy and neuromodulation neuropathic pain RCTs. Of 288 papers, 36 (12.5%) reported a BA. One paper reported the results of 2 studies, so in total 37 studies with a BA were assessed. Of these, 19 were crossover, 17 parallel, and 1 partial crossover in design. All 37 studies assessed participant blinding, and 10 also assessed investigator blinding. Approximately 27% included an "unsure" answer option for treatment guess, and 38% asked the reason for the guess. There were no clear patterns in BA reporting across time nor based on treatment type. Seventeen trials provided sufficient data to calculate Bang Blinding Index (BI) to determine blinding success. Participants remained blinded (BI = 0 ± 0.2) in 10/17 placebo and 10/17 treatment arms, 6 placebo and 5 treatment arms had a BI > 0.2 suggesting possible unblinding, whereas 1 placebo and 2 treatment arms had a BI < -0.2 suggesting misinformed guessing. Overall, we found that BAs are done in a minority of published neuropathic pain trials and with variable methodology. Given the importance of minimizing risk of bias because of treatment unblinding, future studies should consider including BAs, and further consensus building is necessary to determine if and how BAs should be conducted and interpreted in analgesic clinical trials.

Bias↗

PubMed2026

Impact of Physical Environment of Pediatric Inpatient Wards on Children: A Systematic Literature Review.

ObjectiveThe study aimed to examine empirical studies published between 2003 and 2025 to identify elements of physical environments influencing health outcomes and experiences of children and families.BackgroundIn the past 40 years, research has shown that the physical environment influences the health and well-being of patients in the healthcare environment. However, similar research in the context of "pediatric inpatient wards" remains underexplored.MethodsPubMed, Embase, Scopus, and Web of Science were used to identify relevant articles. All extracted articles underwent a three-step screening process using PRISMA. A total of 30 eligible articles were used for the analysis. The protocol is registered at PROSPERO (CRD42023408997).ResultsKey findings reveal positive and negative impacts of identified elements. Positive-effect elements include play spaces, space for parents, natural light, connections with nature, and so on, which promote comfort, healing, and emotional resilience. Conversely, negative-effect elements, such as noise, artificial lighting, uncomfortable temperature, and so on, contribute to stress and disrupted sleep. Mixed effects were observed for elements like art and television, which underscore the complexity of designing environments that address the diverse needs of different age groups and genders.ConclusionsThe review findings highlight significant knowledge gaps. The study also tries to bridge existing gaps between research and practice by systematically identifying environmental elements, offering actionable insights to architects, designers, healthcare providers, and policymakers. Future research must adopt rigorous, culturally inclusive approaches to advance the field of pediatric healthcare design and ensure equitable care across diverse sociocultural contexts.

Humans↗

PubMed2025

A Digital Tool for Clinical Evidence-Driven Guideline Development by Studying Properties of Trial Eligible and Ineligible Populations: Development and Usability Study.

BACKGROUND: Clinical guideline development preferentially relies on evidence from randomized controlled trials (RCTs). RCTs are gold-standard methods to evaluate the efficacy of treatments with the highest internal validity but limited external validity, in the sense that their findings may not always be applicable to or generalizable to clinical populations or population characteristics. The external validity of RCTs for the clinical population is constrained by the lack of tailored epidemiological data analysis designed for this purpose due to data governance, consistency of disease or condition definitions, and reduplicated effort in analysis code. OBJECTIVE: This study aims to develop a digital tool that characterizes the overall population and differences between clinical trial eligible and ineligible populations from the clinical populations of a disease or condition regarding demography (eg, age, gender, ethnicity), comorbidity, coprescription, hospitalization, and mortality. Currently, the process is complex, onerous, and time-consuming, whereas a real-time tool may be used to rapidly inform a guideline developer's judgment about the applicability of evidence. METHODS: The National Institute for Health and Care Excellence-particularly the gout guideline development group-and the Scottish Intercollegiate Guidelines Network guideline developers were consulted to gather their requirements and evidential data needs when developing guidelines. An R Shiny (R Foundation for Statistical Computing) tool was designed and developed using electronic primary health care data linked with hospitalization and mortality data built upon an optimized data architecture. Disclosure control mechanisms were built into the tool to ensure data confidentiality. The tool was deployed within a Trusted Research Environment, allowing only trusted preapproved researchers to conduct analysis. RESULTS: The tool supports 128 chronic health conditions as index conditions and 161 conditions as comorbidities (33 in addition to the 128 index conditions). It enables 2 types of analyses via the graphic interface: overall population and stratified by user-defined eligibility criteria. The analyses produce an overview of statistical tables (eg, age, gender) of the index condition population and, within the overview groupings, produce details on, for example, electronic frailty index, comorbidities, and coprescriptions. The disclosure control mechanism is integral to the tool, limiting tabular counts to meet local governance needs. An exemplary result for gout as an index condition is presented to demonstrate the tool's functionality. Guideline developers from the National Institute for Health and Care Excellence and the Scottish Intercollegiate Guidelines Network provided positive feedback on the tool. CONCLUSIONS: The tool is a proof-of-concept, and the user feedback has demonstrated that this is a step toward computer-interpretable guideline development. Using the digital tool can potentially improve evidence-driven guideline development through the availability of real-world data in real time.

Humans↗