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Periodic health examination, 1996 update: 1. Prenatal screening for and diagnosis of Down syndrome. Canadian Task Force on the Periodic Health Examination.

OBJECTIVE: To make recommendations to physicians providing prenatal care on (1) whether prenatal screening for and diagnosis of Down syndrome (DS) is advisable and (2) alternative screening and diagnosis manoeuvres. OPTIONS: "Triple-marker" screening of maternal serum levels of alpha-fetoprotein, human chorionic gonadotropin and unconjugated estriol; fetal ultrasonographic examination; amniocentesis; and chorionic villus sampling (CVS). OUTCOMES: Accuracy of detection of DS in fetuses, and risks to the mother, including psychologic distress, and to the fetus from the screening and diagnostic interventions. EVIDENCE: A MEDLINE search for relevant articles published from Jan. 1, 1966, to Mar. 31, 1994, with the use of MeSH terms "Down syndrome," "prenatal diagnosis," "screening," "prevention," "amniocentesis," "chorionic villus sampling," "ultrasonography," "anxiety," "depression" and "psychological stress" and a manual search of bibliographies, recent issues of key journals and Current Contents. VALUES: The evidence-based methods and values of the Canadian Task Force on the Periodic Health Examination were used. A high value was placed on providing pregnant women with the opportunity to determine whether they are carrying a fetus with DS and to make choices concerning the termination of the pregnancy. The economic issues involved are complex and were not considered. BENEFITS, HARMS AND COSTS: Triple-marker screening identifies an estimated 58% of fetuses with DS, but it has an estimated rate of true-positive results of 0.1% and of false-positive results of 3.7% (given a risk cut-off of one chance in 190 of DS). These rates vary with maternal age and the risk cut-off chosen. Women with a known risk of having a fetus with DS (e.g., those who have had a previous child with DS) may benefit from a reduction in anxiety after confirmation that their fetus does not have DS. Screening allows women at low risk of having a child with DS to detect fetuses with the syndrome, but may cause psychologic distress if there is a false-positive screening test result. Up to 20% of women with positive results of screening tests may decline to undergo a subsequent amniocentesis. Amniocentesis and CVS are very accurate in diagnosing DS in fetuses and have a very low rate of serious complications for the mother. Amniocentesis is associated with a 1.7% rate of fetal loss when it is performed after 16 weeks' gestation, whereas the rate among controls is 0.7% (for a difference of 1%, 95% confidence interval 0.3% to 1.5%). CVS entails a greater risk of fetal loss than amniocentesis (odds ratio 1.32, 95% confidence interval 1.11 to 1.57). There is little evidence from controlled trials of significant associations between amniocentesis or CVS and neonatal morbidity or malformations; however, samples have been too small to show differences in rare outcomes. Results from some case-control studies suggest that CVS increases the risk of transverse limb deficiency. Costs were not considered because they are beyond the scope of this review. RECOMMENDATIONS: There is fair evidence to offer triple-marker screening through a comprehensive program to pregnant women under 35 years of age (grade B recommendation). Women given detailed information about serum-marker screening show more satisfaction with the screening than those not given this information. There is fair evidence to offer amniocentesis or CVS to pregnant women 35 years of age and older and to women with a history of a fetus with DS or of a chromosome 21 anomaly (grade B recommendation). Information on the limitations and advantages of each procedure should be offered. Triple-marker screening may be offered as an alternative to CVS or amniocentesis to pregnant women over 35. VALIDATION: Recommendations concerning prenatal diagnosis are similar to those of the US Preventive Services Task Force, the Society of Obstetricians and Gynaecologists of Canada, the Canadian College of Medical Geneticists and the Cochrane Pregnancy and Childbirth Group. No previous specific recommendations concerning triple-maker screening exist. SPONSORS: These guidelines were developed and endorsed by the Canadian Task Force on the Periodic Health Examination, which is funded by Health Canada and the National Health Research and Development Program.

Abortion, Eugenic↗

Meta-analysis, clinical trials, and transferability of research results into practice. The case of cholesterol-lowering interventions in the secondary prevention of coronary heart disease.

OBJECTIVE: To evaluate, in the comprehensive scenario of "evidence-based" medicine, the transferability of the results of published randomized clinical trials and meta-analyses on cholesterol-lowering interventions to clinical practice. METHOD: Overview of randomized clinical trials on cholesterol-lowering interventions in the secondary prevention of coronary heart disease. RESULTS: The present overview on secondary prevention of coronary heart disease included 34 trials with cholesterol-lowering interventions in 24968 individuals. There was a 12.5% mortality in the group that was allocated active intervention and a 17.2% mortality in the control group (risk reduction, 13%; 95% confidence interval, -19% to -6%). Coronary and cardiovascular odds of deaths were significantly reduced. No clear association was found between noncoronary mortality and cholesterol-lowering interventions. Baseline total cholesterol levels had no clear influence on total mortality. Intermediate (10%-20%) and high ( > 20%) total cholesterol reductions were associated with similar reductions in the odds of death (-23% and -30%, respectively). No conclusion could be reached for patients who were less represented in the studies (ie, women and elderly persons). Patients with more complicated baseline clinical conditions (eg, congestive heart failure) had little nonsignificant benefit from cholesterol-lowering interventions. CONCLUSIONS: The effect of cholesterol-lowering interventions at least in the secondary prevention of coronary heart disease can be considered as established, but the transferability of such results to real-life patients remains the critical, unanswered question.

Anticholesteremic Agents↗

Periodic health examination, 1996 update: 2. Screening for chlamydial infections. Canadian Task Force on the Periodic Health Examination.

OBJECTIVE: To update the 1984 recommendations of the Canadian Task Force on the Periodic Health Examination on the routine screening of asymptomatic patients for infection with Chlamydia trachomatis. OPTIONS: Screening, with the use of culture or nonculture tests, of the general population, of certain high-risk groups or of all pregnant women; or no routine screening. OUTCOMES: Rates of asymptomatic and symptomatic chlamydial infection, perinatal complications, longterm complications of infection (i.e., pelvic inflammatory disease, infertility and ectopic pregnancy), coinfection with other sexually transmitted diseases, disease spread, hospital care, complications of therapy and costs of infection and of screening. EVIDENCE: Search of MEDLINE for articles published between Jan. 1, 1983, and Dec. 31, 1995, with the use of the major MeSH heading "chlamydial infections," references from recent review articles and recommendation by other organizations. VALUES: The evidence-based methods of the Canadian Task Force on the Periodic Health Examination were used. Advice from reviewers and experts and recommendations of other organizations were taken into consideration. Prevention of symptomatic disease and decreased overall costs were given high values. BENEFITS, HARMS AND COSTS: The greatest potential benefits of screening asymptomatic patients for chlamydial infections are the prevention of complications, especially infertility and perinatal complications, and the prevention of disease spread. There is no evidence that screening of the general population for chlamydial infections leads to a reduction in complications, and screening may increase costs. However, there is evidence that annual screening of selected high-risk groups and of pregnant women during the first trimester is beneficial in preventing symptoms and reducing the overall cost resulting from infection. RECOMMENDATIONS: There is fair evidence to support screening and treatment of pregnant women during the first trimester (grade B recommendation) as well as annual screening and treatment of high-risk groups (sexually active women less than 25 years of age, men or women with new or multiple sexual partners during the preceding year, women who use nonbarrier contraceptive methods and women who have symptoms of chlamydial infection: cervical friability, mucopurulent cervical discharge or intermenstrual bleeding; grade B recommendation). There is fair evidence to exclude routine screening of the general population (grade D recommendation). VALIDATION: These recommendations are similar to those of the US Preventive Services Task Force and the US Centers for Disease Control and Prevention, Atlanta. SPONSOR: These guidelines were developed and endorsed by the Canadian Task Force on the Periodic Health Examination, which is funded by Health Canada and the National Health Canada and the National Health Research and Development Program. The principal author (H.D.D.) was supported in part by the Ontario Ministry of Health and the Canadian Infectious Diseases Society Lilly Fellowship.

Chlamydia Infections↗

[Evidence based medicine, the Cochrane Collaboration and dealing with medical literature. Implications for medical education, graduate and continuing education].

The concept of evidence-based medicine yields to provide medical practice with actual scientific evidence, which raises from a comprehensive analysis of randomized controlled studies. The article reviews recent approaches, especially in the field of primary care (resp. family medicine) and points out the various outcomes of this concept within an analysis of the German system of medical instruction and continuing education. This approach, as all other components of medical education, shall prove its efficacy in further studies evaluating the impact on achievement in patient's care.

Curriculum↗

Practice Guidelines for blood component therapy: A report by the American Society of Anesthesiologists Task Force on Blood Component Therapy.

In 1994, the American Society of Anesthesiologists established the Task Force on Blood Component Therapy to develop evidence-based indications for transfusing red blood cells, platelets, fresh-frozen plasma, and cryoprecipitate in perioperative and peripartum settings. The guidelines were developed according to an explicit methodology. The principal conclusions of the task force are that red blood cell transfusions should not be dictated by a single hemoglobin "trigger" but instead should be based on the patient's risks of developing complications of inadequate oxygenation. Red blood cell transfusion is rarely indicated when the hemoglobin concentration is greater than 10 g/dL and is almost always indicated when it is less than 6 g/dL. The indications for autologous transfusion may be more liberal than for allogeneic (homologous) transfusion. The risks of bleeding in surgical and obstetric patients are determined by the extent and type of surgery, the ability to control bleeding, the actual and anticipated rate of bleeding and the consequences of uncontrolled bleeding. Prophylactic platelet transfusion is ineffective when thrombocytopenia is due to increased platelet destruction. Surgical and obstetric patients with microvascular bleeding usually require platelet transfusion if the platelet count is less than 50 times 10(9)/l and rarely therapy if it is greater than 100 times 10(9)/l. Fresh-frozen plasma is indicated for urgent reversal of warfarin therapy, correction of known coagulation factor deficiencies for which specific concentrates are unavailable, and correction of microvascular bleeding when prothrombin and partial thromboplastin times are >1.5 times normal. It is contraindicated for augmentation of plasma volume or albumin concentration. Cryoprecipitate should be considered for patients with von Willebrand's disease unresponsive to desmopressin, bleeding patients with von Willebrand's disease, and bleeding patients with fibrinogen levels below 80-100 mg/dL. The task force recommends careful adherence to proper indications for blood component therapy to reduce the risks of transfusion. (Key words:Practice guide-lines: anemia: blood component therapy; coagulopathy; cryoprecipitate; fresh-frozen plasma; red blood cells; transfusion.)

Anesthesia↗

Managing early presentation of rheumatoid arthritis. Systematic overview.

OBJECTIVE: To describe evidence-based management of patients presenting to family physicians with typical signs and symptoms of recent onset of rheumatoid arthritis (RA). STUDY SELECTION: Articles for critical review were included if relevant to primary care management of early RA (less than 1 year duration). Sources included MEDLINE from 1966 to December 1995, the reference library of the Arthritis Community Research and Evaluation Unit, and conference abstracts. FINDINGS: Evidence from randomized, controlled trials supports the short-term benefit of nonsteroidal anti-inflammatory drugs, disease-modifying agents for rheumatic diseases, intravenous pulse corticosteroid therapy, intra-articular therapy, aerobic exercise, patient education, psychologic intervention, home physiotherapy, home occupational therapy, and rehabilitation programs. Some evidence favours acetaminophen for analgesia, low-dose oral corticosteroids for symptom control, and referral to a rheumatologist. Evidence for rest, ice, and heat for symptom control is conflicting and based on low-quality studies. CONCLUSION: Family physicians play an important role in establishing early and accurate diagnosis of RA, coordinating therapy, and providing ongoing support, education, and monitoring to patients and their families.

Arthritis, Rheumatoid↗

Postgraduate training for rural family practice. Goals and opportunities.

PROBLEM BEING ADDRESSED: The continuing shortage of rural family physicians in Canada. PURPOSE OF PROGRAM: To further develop training for rural family practice so that adequate numbers of rural family physicians will be appropriately prepared. MAIN COMPONENTS OF PROGRAM: All family medicine residents should have the opportunity to experience the joys and challenges of rural family practice. Rural family medicine training streams provide the best education for family medicine residents who are planning a career in rural family medicine. Integrated training for rural family practice should be high-quality, academically sound, needs-driven, evidence-based, learner-centered, and outcome-measured. This involves comprehensive development of curricula that provide specific skills and appropriate core subjects in rural practice as well as a solid family medicine foundation. contextual and experiential learning in areas similar to or in actual areas where there is a need for rural physicians, and appropriate hospital rotations to learn skills for the hospital role of many rural family doctors, are important components of rural family medicine training. CONCLUSIONS: Postgraduate rural family medicine training programs can be further focused and developed to train more physicians with the knowledge, skills, and attitudes required for rural practice.

Canada↗

Changing nursing practice--trisectoral collaboration in decision making.

In an age of cost containment, agency partnerships have become an essential element for future planning and program implementation. This paper describes a trisectoral collaboration of a hospital, health department, university and school of nursing to compare the efficacy and efficiency of referral decisions of hospital staff nurses to those of the public health liaison nurses (LNs). A process to identify decision criteria was undertaken and an educational programme was designed to assist the staff nurses with the referral process and to assure consistency of decision making. The two groups were then compared. The results of the study found staff nurses, using the decision criteria, identified more patients who required public health nursing visits than did the liaison nurses, refusal rate of the patients to participate was no different, staff nurses cost less than LNs and job satisfaction was not significantly altered for either group. In addition to providing information to guide administrative and clinical decision making, the project also provided a learning experience for the staff of three agencies in conducting research and in using evidence-based practice to change traditional practice.

Decision Making, Organizational↗

Plethysmography: safety, effectiveness, and clinical utility in diagnosing vascular disease.

Plethysmography, a semiquantitative method of measuring segmental blood flow and velocity in the carotid and peripheral vascular systems, is safe, easy to perform, and inexpensive. Impedance, strain guage, air, and photoelectric plethysmographic methods are assessed in this publication for their relative safety, efficacy, and clinical utility in diagnosing vascular disease. Clinical evidence has demonstrated, for example, that oculoplethysmography is not a reliable screening test for carotid artery disease, particularly in bilateral disease and nonocclusive unilateral disease. Oculoplethysmography is thus no longer recommended for the diagnosis of carotid artery disease. Impedance, strain guage, and photoplethysmography methods can be used for the initial evaluation of acute and chronic venous insufficiency, although there is great variability in the reliability of these tests to predict venous disease in the presence of nonobstructive thrombi and comorbid conditions. Strain guage and photoelectric plethysmography can be safely used for the evaluation of peripheral arterial disease. But surgical candidates for arterial reconstruction and some venous disorders may require additional imaging such as duplex ultrasound, venography, or arteriography for anatomic information that is not elucidated by plethysmography. The plethysmographic techniques reviewed in this assessment, evaluating the ability to predict the presence of flow reduction in the carotid and peripheral circulations, are based on the technical performance of the tests as compared with a reference method. Establishing evidence-based conclusions proved difficult in light of biases such as nonrandomization, unstated patient selection criteria, poor followup of patients, and lack of blindness in some studies.

Humans↗

The role of lipids in cardiovascular disease: lessons from rare mutations and special populations.

OBJECTIVE: To review approaches to determining the genetic basis of atherogenesis, the interaction of genes with the environment and with other genes, and the contribution to knowledge of data from subjects with rare mutations and from genetically isolated populations. DATA SOURCES AND SELECTION: Current literature, including studies of Canadian families with genetic mutations by the author, on the role of genetic factors in dyslipidemia and atherosclerosis. DATA EXTRACTION: Studies that have shown effects of gene products on plasma levels of cholesterol and lipids and subsequent atherogenesis. DATA SYNTHESIS: Studies in families with rare mutations indicate that a single genetic change has a profound effect on phenotype, but the possible clinical application of this information is restricted mainly to members of the extended family. In contrast, studies carried out in large populations show that many genetic factors each have a small impact on phenotype and that these effects are further obscured by environmental factors. The clinical relevance of such findings is unclear. CONCLUSIONS: Ideally, the information gained from new molecular approaches to identifying the determinants of the intermediate phenotypes of atherosclerosis should be integrated into evidence-based practice. However, the complicating factors are formidable. The use of genetic information to identify subjects at high risk of the clinical end points of atherosclerosis and to enhance health care delivery to such subjects is questionable.

Arteriosclerosis↗

The impact of health policy on chiropractic.

OBJECTIVE: The chiropractic profession has traditionally had little or no direct influence on health policy. Conversely, every chiropractor is impacted daily by health policy decisions promulgated by government agencies, health purchasers, managed care organizations and others. This discussion provides an overview of health policy constituencies important to chiropractors, reviews processes currently being used to assess health care technology and develop policy and offers strategies for the profession to more actively engage in constructive policy development. METHOD: Descriptive overview of key issues based on qualitative selective overview of literature and author's observations based on two years employment in a government health policy position. CONCLUSIONS: The chiropractic profession's traditional approach to influencing health policy has focused on public relations, political lobbying for favorable legislation and litigation, which has increased public awareness and resulted in a number of legislative successes. However, for the most part, the momentum of decision-making at agency levels and in policy staff positions continues to occur without involvement of chiropractors trained or experienced in policy-making. This is in contrast with medicine and other allied health fields, whose ranks hold such positions routinely. Additionally, methodology for policy decision-making is increasingly evidence-based. Strategies for the chiropractic profession to more actively participate in this arena are offered.

Chiropractic↗

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↗

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↗

Sore throat management in general practice.

This paper discusses primary care management of sore throat in the context of recent national 'consensus' guidelines from the Drugs and Therapeutics Bulletin. The guidelines advise taking a throat swab, using typical clinical features where swabs are not available, and suggest that antibiotics shorten the duration of symptoms and prevent complications. Systematic reviews and individual studies indicate that the evidence for prescribing antibiotics for most presentations of sore throat in general practice is marginal, and the benefits are probably outweighed by the likely costs of antibiotics. Using clinical scorecards or symptom clusters to identify individuals who would benefit from treatment is insensitive with low predictive value, although inexpensive. Using throat swabs as a gold standard for diagnosis is inappropriate since they are neither very specific nor sensitive, and will greatly increase costs of management. The relative lack of evidence for the efficacy of antibiotics and for the use of throat swabs from primary care research, and also an unbalanced perspective of dangers and complications related predominantly to a secondary care setting, underlines the problem of achieving valid consensus guidelines. Guidelines not firmly based on evidence appropriate to the intended setting are more likely to be received sceptically and hinder getting research into practice.

Anti-Bacterial Agents↗

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 &#xb1; 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↗

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↗

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↗

Hyperbaric oxygen for the treatment of traumatic incomplete spinal cord injury: a systematic review and meta-analysis of randomized controlled trials.

The therapeutic efficacy of hyperbaric oxygen therapy for traumatic incomplete spinal cord injury remains a subject of debate. To comprehensively evaluate the impact of hyperbaric oxygen on motor function, sensory function, and activities of daily living in patients with traumatic incomplete spinal cord injury, we conducted a systematic review and meta-analysis. We performed a comprehensive search across PubMed, Embase, the Cochrane Library, Web of Science, and major Chinese databases for randomized controlled trials published through June 2025. A total of 15 randomized controlled trials were included. The pooled results indicated that hyperbaric oxygen therapy significantly improved the American Spinal Injury Association motor score (mean difference = 10.30, 95% confidence interval: 7.70-12.90), the total American Spinal Injury Association sensory score (mean difference = 29.29, 95% confidence interval: 18.82-39.75), the American Spinal Injury Association light touch score (mean difference = 9.84, 95% confidence interval: 6.15-13.53), and the American Spinal Injury Association pinprick score (mean difference = 8.75, 95% confidence interval: 4.40-13.11). Furthermore, hyperbaric oxygen therapy was associated with significant enhancements in the Barthel Index (mean difference = 16.60, 95% confidence interval: 10.51-22.68) and the Functional Independence Measure (mean difference = 17.41, 95% confidence interval: 10.83-23.98). In conclusion, adjunctive hyperbaric oxygen therapy appears to improve motor function, sensory function, and activities of daily living in patients with traumatic incomplete spinal cord injury compared to conventional treatments alone. However, due to methodological limitations and potential publication bias in the included studies, these findings should be interpreted with caution, and further high-quality, multi-center randomized controlled trials are warranted.

Humans↗