Evidence-Based Medicine

Research Appraisals

Evidence-based critical appraisals of the latest medical research, systematically evaluated using Oxford CEBM methodology.

Showing 19 appraisals

otherEvidence: Moderate
80CEBM

Journal of medical Internet research

Experiences of Home-Dwelling Older Adults and Their Family Caregivers With Digital Health Services: Qualitative Study

BACKGROUND: As the population ages, demand for health services among older adults and caregivers increases. Digital health services help meet this demand. However, acceptance and experiences differ between older adults and caregivers. OBJECTIVE: This study aims to explore the specific experiences of home-dwelling older adults and their caregivers with digital health services, identify their willingness to use these services and the factors influencing their adoption, and identify their service needs to inform the subsequent design and optimization of digital health products and services. METHODS: From December 2023 to February 2024, a descriptive qualitative study was conducted. Researchers used purposive and maximum variation sampling to recruit 18 home-dwelling older adults and 17 family caregivers, including 10 matched dyads. Participants came from 7 community health service centers and a tertiary hospital in Hefei, China. Open-ended, semistructured, face-to-face interviews were conducted separately. Data were analyzed using conventional content analysis. RESULTS: Four main themes emerged. The first were the application characteristics, including usage situations and preferred functions. The second theme described specific service experiences, both positive and negative. The third was the influencing factors. Promoting factors included health needs, user experience, and subjective norms. Obstructive factors differed between groups and included low digital literacy, weak economic foundation, service security concerns, and lack of time. The fourth theme covered suggestions and expectations for improvement. Older adults appreciated the advantages but often had suboptimal experiences due to complex designs and threats to personal dignity. Conversely, caregivers valued efficiency but reported low use, hindered by time constraints and concerns about privacy and safety. CONCLUSIONS: This study reveals a critical gap between the potential and actual use of digital health services. Older adults face barriers with usability and digital literacy. Caregivers struggle to integrate these services and have trust issues. Future optimization requires action at several levels. Government support is needed through policies, authoritative platforms, and subsidies. Service providers should offer age-friendly, personalized design, and continuous support. Social support systems are also essential, such as digital reciprocity from family and peer help. These strategies are critical for enhancing user experience, bridging the digital divide, and enabling both older adults and their caregivers to fully benefit from digital health technologies.

14 June 2026

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Systematic ReviewEvidence: Weak
60CEBM

BMC geriatrics

Components and effects of psychosocial support interventions for relatives of patients with delirium in hospitals, systematic review

BACKGROUND: Relatives of patients with delirium are often confronted with patients' challenging behaviours such as hyperactivity, aggression, or hallucinations. As a result, feelings of anxiety and depression episodes have been described. The aim is to identify psychosocial support intervention for relatives of patients with delirium in hospitals, describe components and effects, and identify research gaps. METHODS: Systematic review based on PRISMA, including psychosocial support intervention studies addressing burden and support needs of adult relatives of hospital patients with delirium. We searched the databases Medline, Web of Sience, CINAHL, Livivo, PsycINFO, and Cochrane Library in 07/2024 and reference lists. We assessed reporting using TIDieR and CReDECI2 and methodological quality using ROB-1 and the JBI tool for quasi-experimental studies. We performed narrative syntheses. RESULTS: We identified eight intervention studies addressing relatives of patients with delirium in different settings. Intervention components included provision of information using flyers, videos, web-sites, or telephone calls, and mentoring in the intensive care unit. Reporting of interventions was mostly poor. No study reported a process evaluation. Four of six studies showed a significant difference in relatives' delirium knowledge. For relatives' psychological outcomes, no clear effects were shown. Overall, study quality was limited. CONCLUSIONS: More effectiveness studies are needed with better reporting of intervention components, ideally addressing psychological aspects. Feasibility and acceptance of new interventions should be described within accompanying process evaluations. TRIAL REGISTRATION: https://osf.io/7jbsk .

13 June 2026

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Systematic ReviewEvidence: Moderate
80CEBM

Neurology

Efficacy of Levetiracetam in Patients With Pediatric Epilepsy: A Systematic Review and Meta-Analysis

BACKGROUND AND OBJECTIVES: Levetiracetam (LEV) is widely used in pediatric epilepsies because of its favorable pharmacokinetics, ease of administration, and perceived tolerability. However, its comparative efficacy relative to established antiseizure medications (ASMs) in children remains uncertain. We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate LEV efficacy in pediatric epilepsies and compare outcomes vs placebo and active comparators. METHODS: We systematically searched PubMed/MEDLINE and Embase (2000-6 August 2025) for RCTs enrolling patients 16 years or younger with epilepsy and reporting seizure freedom and/or ≥50% responder rate. Trials including both pediatric and adult patients were eligible if pediatric participants were represented. Comparisons included LEV vs placebo or active ASMs as monotherapy or adjunctive therapy. Primary outcomes were seizure freedom and responder rate at the trial's primary endpoint or, if not specified, longest reported follow-up. We assessed risk of bias using Cochrane Risk of Bias 2. We pooled risk differences (RDs) with 95% CIs using random-effects models, stratified by comparator and epilepsy subtype. RESULTS: We included 25 RCTs (4,070 participants): 23 contributed to pooled meta-analyses. Across 25 trials, the mean age ranged from 0.4 to 39.3 years, reflecting pediatric-only and mixed-age RCTs; 43.8% were female. In placebo/no-therapy-controlled trials (mainly add-on studies), LEV was associated with higher seizure freedom (RD 11.0%; 95% CI 5.3%-16.7%) and responder rates (RD 24.3%; 95% CI 19.1%-29.4%). In active-comparator-controlled trials (mainly monotherapy head-to-head studies), LEV showed no overall advantage vs active comparators for seizure freedom (RD -2.4%; 95% CI -5.6% to 0.7%) or responder rate (RD -7.4%; 95% CI -23.0% to 8.1%). Fourteen trials were at high risk of bias. Sensitivity analyses confirmed benefit vs placebo but showed significant disadvantage vs active comparators in low risk-of-bias trials. Findings in pediatric-only trials (16 RCTs; 1,380 participants) were consistent with the overall results. DISCUSSION: LEV confers benefit vs placebo, mostly as adjunctive therapy, but does not consistently outperform established ASMs in pediatric epilepsies and may be inferior in some subgroups when higher-quality evidence is considered. Limitations include substantial heterogeneity, frequent high risk of bias, variable follow-up durations, publication bias, and limited pediatric-only comparative data.

28 May 2026

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Systematic ReviewEvidence: Moderate
75CEBM

Journal of perinatal medicine

Early kangaroo care in preterm ≤32 weeks and very low birth weight infants: a systematic review and meta-analysis

OBJECTIVES: Kangaroo care (KC), involving skin-to-skin contact, early breastfeeding and early discharge, demonstrated benefits in improving outcomes for preterm and low birth weight infants. This systematic review and meta-analysis aimed to evaluate the effectiveness of early KC (initiated within the first 24 h) vs. conventional neonatal care in very preterm infants (≤32 weeks) and/or very low birth weight (VLBW) infants (<1,500 g). METHODS: A comprehensive search of MEDLINE, SCOPUS, Web of Science, and CENTRAL databases was conducted. Randomized controlled trials (RCTs) comparing early KC to conventional care in very preterm and/or VLBW infants were included. Risk of bias was assessed using the Cochrane Risk of Bias tool. Meta-analysis was conducted using R, with relative risks (RR) and 95 % confidence intervals (CI) calculated. RESULTS: Four RCTs, encompassing 1,679 newborns, were included. Meta-analysis revealed a significant reduction in mortality risk (RR=0.81, 95 % CI: 0.67-0.98) with early KC. The pooled RR for infection risk was 0.89 (95 % CI: 0.77-1.02). The impact on hypothermia was mixed, with moderate heterogeneity observed. CONCLUSIONS: Early KC may reduce mortality and morbidity in very preterm and VLBW infants although its effects on hypothermia vary by severity. Further studies are required to assess its effects on infants weighing <1,000 g or born before 28 weeks of gestation.

26 May 2026

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Randomised Controlled TrialEvidence: Weak
75CEBM

BMC public health

Little All Children in Focus (Little ACF) - evaluation of a parenting support programme for parents of children aged 1-2 years in Sweden: a randomised controlled trial

INTRODUCTION: The first two years of life affect health over the life course. Universal parenting support programmes may promote child health during these years but there is a lack of such evidence-based programmes. Our aim was to study the direct effects of a structured 4 sessions universal parenting programme for parents with children 1-2 years old, Little All Children in Focus, in Sweden. METHODS: A two-arm parallel randomised controlled superiority trial with 832 Swedish-speaking parents was conducted to evaluate the effectiveness of the Little All Children In Focus programme in comparison with an active control receiving four digital lectures on child development and parenthood. The participants completed questionnaires at baseline and post intervention measuring the primary outcomes: parenting self-efficacy and stress, coparenting quality, emotion regulation for parents and emotion regulation strategies for their children, and secondary outcome: child socioemotional development. A third research question concerned whether the intervention could engage and retain parents in groups. An intention-to-treat approach was applied using linear mixed models for analysing the effectiveness of the programme. RESULTS: Parents who participated in the programme demonstrated greater improvements in supportive emotion regulation strategies compared to the active control (β = 3.0, CI = 0.9 - 5.0), while no notable group differences emerged across the remaining outcome measures. The program demonstrated high levels of parental engagement and retention in group settings. CONCLUSIONS: Little All Children in Focus demonstrates potential in promoting supportive parenting emotion regulation strategies among Swedish speaking parents to 1-2-year-olds. The intervention also seems to have potential to engage parents. However, further evaluations must be conducted to provide a deeper understanding of the long-term impact of this universal parenting support programme. TRIAL REGISTRATION: The study protocol https://rdcu.be/eAxn2 was published at www. CLINICALTRIALS: gov with registration number: NCT05445141 (registered on July 06, 2022).

21 May 2026

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observationalEvidence: Weak
65CEBM

JMIR medical informatics

The Impact of Electronic Health Records on Family Physicians During Simulated Virtual Encounters: Exploratory Mixed Methods Study

BACKGROUND: This exploratory study investigated the impact of computer use on physician performance during clinical simulations. Standardized patient (SP) scenarios used in family practice certification examinations were adapted to include the use of the electronic health record (EHR). OBJECTIVE: The goal was to compare the impact of EHR use during simulated virtual patient encounters on resident physicians' and staff physicians' patient-centeredness (PC) and overall clinical performance, as well as to measure the cognitive load (CL) imposed by EHR use. METHODS: Sixteen participants each completed 2 video telemedicine simulations with SPs. One simulation case included limited past medical history for the SP in the EHR, while the other did not. Participants were instructed to completely document the encounter using the EHR. Participants' self-perceived CL was measured using the raw National Aeronautics and Space Administration Task Load Index (NASA-TLX). Video recordings were analyzed for participant PC and overall clinical performance. In addition to interacting with the EHR, multiple participants also conducted internet searches. The proportion of time that participants spent interacting with the computer, either using the EHR or searching the internet, was calculated. Inductive qualitative coding of a subset of video recordings (18 of 32 encounters) was performed, with a focus on signs of stress/CL. All videos were assessed for usability problems. RESULTS: Staff physicians (n=6) scored higher on PC compared to resident physicians (n=10) for both cases, though differences were not statistically significant after correction for multiple comparisons (family-wise error rate). Physicians' overall CL, as measured by the raw NASA-TLX, was not significantly correlated with computer use. Exploratory qualitative data analysis found both verbal and nonverbal signs of stress/CL due to computer use while interacting with the SPs. The proportion of time displaying nonverbal signs of stress/CL was calculated for a subset of participants (6 resident physicians and 3 staff physicians). Participant interpretations of instructions to completely document the encounter using the EHR varied widely. It is likely that participants' usual style of documenting, either primarily during or after patient encounters, impacted their use of the EHR while SPs were present. CONCLUSIONS: Use of the computer during video telemedicine appointments may negatively impact physician PC and overall clinical performance. Exploratory qualitative coding identified both verbal and nonverbal signs of stress/CL when participants interacted with the computer and the patient simultaneously. Increased clinical experience helped to mitigate the negative impact of computer use. If the use of the EHR is included in physician certification examinations, clear instructions regarding which tasks must be completed in the EHR during interactions with SPs should be provided.

20 May 2026

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qualitativeEvidence: Moderate
80CEBM

Journal of medical Internet research

Digital Patient Decision Aid for Antiobesity Medications: Mixed Methods Study of Human-Centered Design and Usability Evaluation

BACKGROUND: The global burden of obesity continues to rise, highlighting the need for patient-centered approaches to weight management. Shared decision-making is particularly important in the selection of antiobesity medications (AOMs), as treatment options differ in mechanism, effectiveness, side effects, routes of administration, and cost. Despite this preference-sensitive context, only a few patient decision aids (PDAs) have been culturally and clinically adapted for use in Asian populations. OBJECTIVE: This study aims to design, develop, and evaluate a digital PDA, OptiWeight, to support shared decision-making for AOM selection, incorporating perspectives from health care professionals and patients. METHODS: This mixed methods, multicenter study, conducted between August 2022 and November 2025, applied a 4-stage human-centered design process. An evidence-informed prototype was developed based on clinical guidelines, followed by 2 rounds of usability testing using think-aloud protocols to assess navigation structures, perceived usability (System Usability Scale [SUS]), and cognitive workload (NASA Task Load Index [NASA-TLX]). Semistructured interviews with health care professionals specializing in weight management, guided by the Consolidated Framework for Implementation Research, informed clinical implementation and workflow integration. Finally, patients with overweight or obesity evaluated usability, cognitive workload, and overall user experience in outpatient settings. Qualitative data were analyzed using content analysis, and 1-way analysis of variance examined changes in usability and workload across stages. RESULTS: A total of 174 individuals were included across all study stages (usability testing among adults: n=78; health care professional interviews: n=18; and clinical evaluation among patients: n=78). Iterative usability testing comparing system- and user-controlled navigation structures revealed complementary strengths and limitations, leading to the adoption of a hybrid navigation structure supporting both sequential guidance and flexible comparison. Additional design requirements included the use of icon arrays to enhance risk comprehension and localization features such as treatment cost displays and clarification of socially impactful side effects. Perceived usability increased from initial testing to clinical evaluation (SUS: 60.53-73.65, P<.001), meeting good usability thresholds, while cognitive workload decreased (NASA-TLX: 40.35-16.69, P<.001). CONCLUSIONS: Through a systematic human-centered design process integrating health care professional and patient perspectives, OptiWeight addresses the lack of culturally adapted PDAs for AOM decision-making in Mandarin-speaking populations while capturing user needs-particularly regarding navigation flexibility and risk visualization. The final tool demonstrated good usability and feasibility, and workflow considerations suggest potential for integration into routine weight-management care. Further research is needed to evaluate its impact on decision quality and real-world implementation outcomes.

17 May 2026

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Systematic ReviewEvidence: Weak
70CEBM

BMJ open

Regular human insulins versus rapid-acting insulin analogues in children and adolescents with type 1 diabetes: a systematic review with meta-analysis and trial sequential analysis

OBJECTIVES: To assess the beneficial and harmful effects of regular human insulins versus rapid-acting insulin analogues in children and adolescents with type 1 diabetes. DESIGN: Systematic review of randomised clinical trials with meta-analysis and trial sequential analysis. DATA SOURCES: CENTRAL, MEDLINE, Embase, LILACS and other sources from inception to 30 January 2026. STUDY SELECTION: Randomised clinical trials comparing regular human insulins versus rapid-acting insulin analogues (insulin aspart, lispro, glulisine) in children and adolescents with type 1 diabetes. ANALYSES: Data were analysed using meta-analysis and trial sequential analysis. Risk of bias was assessed using the Cochrane Risk of Bias tool, V.2, and the certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. PRIMARY OUTCOMES: Severe hypoglycaemia, ketoacidosis and serious adverse events. RESULTS: 10 trials randomising 1107 participants were included. The certainty of evidence was very low mainly due to high risk of bias and small sample sizes. Meta-analysis showed no evidence of a difference between regular human insulins and rapid-acting insulin analogues on severe hypoglycaemia (risk ratio (RR) 1.28, 95% CI 0.81 to 2.03; I2=0.0%; p=0.2851; nine trials), ketoacidosis (RR 0.88, 95% CI 0.26 to 2.93; I2=0.0%; p=0.8593; two trials) and serious adverse events (RR 1.00, 95% CI 0.44 to 2.25; I2=0.0%; p=0.9958; two trials). Trial sequential analysis showed that all meta-analyses of primary outcomes were underpowered. CONCLUSIONS: Current research shows no differential effects between regular human insulins and rapid-acting insulin analogues for children and adolescents with type 1 diabetes, but the evidence is very uncertain. PROSPERO REGISTRATION NUMBER: CRD42024508625.

16 May 2026

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Systematic ReviewEvidence: Moderate
85CEBM

European respiratory review : an official journal of the European Respiratory Society

Normal polysomnography parameters in healthy children: a systematic review and meta-analysis

INTRODUCTION: There is a lack of normative values for polysomnographic parameters in childhood. This study presents a comprehensive meta-analysis of paediatric polysomnography parameters scored using recent criteria to establish normative values adjusted for age and sex. METHODOLOGY: A systematic search was conducted in Web of Science and Scopus for studies that performed overnight polysomnography in healthy children and reported polysomnographic parameters scored using the American Academy of Sleep Medicine criteria (2007 or 2012). Children with previously diagnosed health conditions were excluded. Estimates for sleep, arousals and cardiorespiratory parameters were pooled using a random-effects meta-analysis and the influence of sex and age was assessed using meta-regression. RESULTS: Of 3612 articles, 66 studies were eligible, resulting in a sample size of 2947 healthy children. Pooled estimates and 95% confidence intervals for 34 polysomnographic parameters were established. Meta-regression revealed age-related decrease in total sleep time (TST), sleep period time, TST in stage N3 and REM, number of sleep cycles, total arousals, total leg movements, periodic leg movement index, central apnoea index, apnoea-hypopnoea index (AHI), mean peripheral oxygen saturation (S pO2 ), mean heart rate in sleep and REM, while the number of awakenings, TST in stage N2, number of stage shifts, and S pO2 nadir increased with age. Sleep latency was the only parameter influenced by sex (change of -1.27 min per 10% increase in the proportion of males). CONCLUSION: This meta-analysis provides normative polysomnographic data for the paediatric population that can be used as control values in both clinical and research context.

15 May 2026

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Systematic ReviewEvidence: Moderate
75CEBM

American journal of speech-language pathology

Parental Roles in Language Intervention: A Systematic Review

BACKGROUND: Children with language delays (LDs) or language disorders face persistent challenges in their development. Speech and language therapy is vital, and within it, parental involvement is recognized as a key factor in therapeutic success. Although many parent-implemented interventions exist, little is known about the specific roles parents assume, particularly across different diagnostic groups: LD, developmental language disorder (DLD), and language disorder associated with other conditions (LD + X). OBJECTIVE: The aim of this study was to review and synthesize evidence on parental roles in language interventions for children with LD, DLD, and LD + X. METHOD: Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and registered in PROSPERO (CRD42023452616), this systematic review analyzed studies from four databases. Eligible studies involved parent participatory language interventions reporting child language outcomes. Two independent reviewers conducted screening, quality appraisal, and data extraction. RESULTS: Across 37 studies, parents most frequently assumed the roles of Learner, Implementer, and Informer, highlighting their functions in acquiring knowledge, applying strategies, and providing feedback on children's progress. Less common roles included Adaptor and Collaborative Decision-Maker, suggesting that although caregivers are increasingly active, their engagement rarely extends to shared decision making with professionals. The studies reviewed here demonstrated considerable variability in intervention dosage, total duration, delivery format, and strategies taught. In contrast, less variability was observed in the identity of the parents/caregivers (most often the mother) and the trainer (typically a speech-language therapist) as well as in the type and mode of delivery. CONCLUSIONS: Parental engagement in language interventions continues to be largely determined by professional guidance, positioning parents as learners and implementers rather than full collaborators. Strengthening adaptive roles and promoting shared decision making can enhance family-centered practice. Future programs could consider the specific needs of each context, encourage parental involvement, and explore telepractice to expand access. SUPPLEMENTAL MATERIAL: https://doi.org/10.23641/asha.32060328.

11 May 2026

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Systematic ReviewEvidence: Moderate
75CEBM

CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne

Screening for high-risk drinking and alcohol use disorder: update of the 2023 national clinical practice guideline

BACKGROUND: Current screening tools for harmful alcohol consumption have fallen out of step with recent guidance on the health risks of alcohol. To address this gap, the Canadian Research Initiative in Substance Matters updated the screening recommendations for high-risk drinking and alcohol use disorder (AUD) in the 2023 national clinical practice guideline. METHODS: Following a systematic review of literature published between Jan. 1, 2013, and Feb. 24, 2023, that examined screening tools for high-risk drinking and AUD, the updated recommendations were developed by a multidisciplinary national committee, which included people with lived and living experience. We scored the recommendations and certainty of evidence using the Grading of Recommendations, Assessment, Development, and Evaluation tool. We used the Appraisal of Guidelines for Research and Evaluation II instrument and the Guidelines International Network's principles for disclosure of interests and management of conflicts to ensure the update met international standards for transparency, high quality, and methodological rigour. RECOMMENDATIONS: Acknowledging that time constraints are the most commonly reported barrier to universal alcohol screening, we developed 5 recommendations involving a simple screening method, to identify and address both unhealthy alcohol consumption and more serious problems related to alcohol. The recommendations include asking all patients about alcohol consumption and providing educational support to all those who drink above Canada's Guidance on Alcohol and Health's low-risk threshold. We propose a simple screening algorithm to optimize and tailor further intervention, including when to assess for possible AUD. INTERPRETATION: The revised screening recommendations represent a timesaving and pragmatic approach intended to be a resource for universal screening for alcohol risks and problems. The recommendations streamline the process of identifying and addressing the health needs of those who consume alcohol in a hazardous way or may have more serious problems related to alcohol.

11 May 2026

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Systematic ReviewEvidence: Moderate
80CEBM

BMJ open

Does previous pregnancy experience improve folic acid supplementation uptake? A systematic review and meta-analysis.

OBJECTIVE: To examine whether multiparous women have more or less folic acid uptake than primiparous women. OUTCOMES: Preconceptional, periconceptional and postconceptional folic acid use among all pregnant women and high risk pregnant women. DESIGN: Systematic review and meta-analysis. DATA SOURCES: MEDLINE-Ovid, CINAHL Ultimate, Scopus and ProQuest Medical. ELIGIBILITY CRITERIA: Observational epidemiological studies comparing folic acid use between primiparous and multiparous women, published in English from January 1994 to June 2024. DATA EXTRACTION AND SYNTHESIS: Two reviewers screened all papers meeting the eligibility criteria. One reviewer completed data extraction and assessed study quality using an adapted version of the Newcastle-Ottawa Scale. Three other reviewers independently assessed 10% of the studies as a quality check. Random-effects (DerSimonian and Laird) meta-analyses combined results for each outcome. Heterogeneity, risk of publication bias and certainty of evidence were assessed. RESULTS: Of the 10 982 records identified, 81 studies involving 826 855 women were included in the review. 27 studies were conducted in Europe, 22 in Asia, 11 in North America, 7 in Africa, 7 in Australia, 5 in the Middle East and 2 in South America. Multiparous women were consistently less likely to take folic acid before and during pregnancy than primiparous women. For preconceptional use, the odds were 29% lower among multiparous women (adjusted OR (aOR): 0.71; 95% CI 0.64 to 0.78; n=25 studies; I2=88.67%), and 58% lower in multiparous high-risk women (aOR: 0.42, 95% CI 0.27 to 0.64; n=3 studies; I2=27.28%). For periconceptional use, the odds were 32% lower among multiparous women (aOR: 0.68; 95% CI 0.63 to 0.74; n=28 studies; I2=85.46%). Postconception, the odds were 21% lower among multiparous women (aOR: 0.79; 95% CI 0.74 to 0.85; n=33 studies; I2=85.91%). By the second trimester, there was no significant difference between the two parity groups (aOR: 0.96; 95% CI 0.87 to 1.05; n=4 studies; I2=0.00%). The certainty of evidence was low for preconceptional, periconceptional and postconceptional uptake due to heterogeneity, and moderate for preconceptional uptake among high-risk women. CONCLUSIONS: Multiparous women were less likely to take folic acid preconceptional, periconceptional and postconceptionally, despite their previous pregnancy experience. Barriers to folic acid supplement uptake among multiparous women need to be identified, and strategies to address them in preconception, antenatal and interconception care should be investigated. PROSPERO REGISTRATION NUMBER: CRD42024553241.

11 May 2026

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Randomised Controlled TrialEvidence: Moderate
65CEBM

The journal of maternal-fetal & neonatal medicine : the official journal of the European Association of Perinatal Medicine, the Federation of Asia and Oceania Perinatal Societies, the International Society of Perinatal Obstetricians

The effect of maternal scent-infused blanket on the stress level, crying duration and physiological parameters of premature newborns

BACKGROUND: Olfactory cues from the mother may soothe distress in premature infants in the Neonatal Intensive Care Unit (NICU). This study evaluated the effect of a maternal scent-infused blanket on stress, crying duration, and physiological parameters in premature newborns. METHODS: This double-blind randomized clinical trial included 69 premature infants who were randomly assigned to one of three groups: maternal scent-infused blanket, unscented blanket, or control (no blanket) group. Infants were covered with the assigned blanket for 60 min daily for 3 consecutive days. The maternal scent was obtained by placing a clean blanket in contact with the mother's bare chest overnight prior to each day's exposure, with fragrance-free cleansing products used and a new blanket for each session. Primary outcomes were stress level (Newborn Stress Scale, NSS), crying duration (chronometer), and Secondary outcomes were physiological parameters (heart rate, respiratory rate, oxygen saturation, and body temperature). Measurements were collected at 5 min before intervention, immediately after, and at 15, 30, 45, and 60 min during intervention, plus 5 min after intervention, each day for three consecutive days. Data were analyzed using one-way ANOVA and ANCOVA adjusting for baseline values; p < 0.05 denoted significance. RESULTS: Stress scores and crying duration differed significantly among groups during the intervention, with the maternal scent-infused blanket group showing lower NSS scores and shorter crying times than the unscented and no-blanket groups (p < 0.001). During exposure, heart rate, oxygen saturation, and body temperature differed among groups (significant at multiple time points, p < 0.001); by contrast, respiratory rate did not differ significantly (p > 0.05). Differences were not observed at baseline or immediately after the intervention for these physiological measures. CONCLUSION: The maternal scent-infused blanket may reduce stress and crying duration, with transient improvements in some physiological parameters during exposure. Maternal olfactory cues could serve as a feasible non-pharmacological adjunct to support comfort and well-being in vulnerable newborns, emphasizing parental involvement in neonatal care.

10 May 2026

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otherEvidence: Insufficient
30CEBM

Journal of medical Internet research

Digital Health Interventions for Family Members of ICU Patients: Current Evidence and Future Directions

A recent systematic review and meta-analysis of randomized trials evaluating digital health interventions for family members of intensive care unit (ICU) patients found no significant improvements in anxiety, depression, posttraumatic stress, quality of life, or communication quality. Rather than concluding that digital approaches are inherently ineffective, we argue that these null findings reflect identifiable and remediable limitations in intervention design, outcome measurement, and trial methodology. In this commentary, we examine four structural barriers that currently constrain the evidence base and outline the conditions that next-generation trials must meet to adequately address the questions raised by this review.

4 May 2026

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observationalEvidence: Strong
90CEBM

Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer

Implementing an electronic health record workflow to identify parents with cancer and implications for supportive oncology care

PURPOSE: Parents with cancer face unique psychosocial challenges as they navigate treatment while caring for dependent children, yet parenthood status is rarely captured in oncology workflows. This initiative evaluated the feasibility and outcomes of a new electronic health record (EHR)-based workflow to systematically identify parents with cancer and then connect them to family-focused assessment and supportive care. METHODS: A two-phase quality improvement initiative was conducted at an NCI-designated comprehensive cancer center. Phase 1 included process mapping, analysis of tumor registry and distress screening data, and development of an EHR screening item assessing parenting status. Phase 2 implemented the item ("Patient is a parent/caregiver with child/ren < 22 years of age?") into oncology workflows, linking identified parents to a new supportive care program, Family Circle, which includes psychosocial assessment, navigation, and family-centered support. Training for oncology clinicians included in-service education. Analyses examined prevalence estimates and associations between parenting, distress, anxiety, and depression and reports of quality improvement metrics. RESULTS: Among N = 2,172 screened patients, 20.6% identified as parents; the age-adjusted prevalence of parenting with children under 21 was 16.9%, consistent with national estimates. Parents reported significantly higher distress (odds ratio [OR] = 1.35, 95% confidence interval [CI] = 1.11-1.64, p = 0.003) and anxiety (OR = 1.28, 95% CI = 1.06-1.52, p = 0.009) than matched non-parents. Parents with younger children exhibited greater anxiety than those with older children (F = 4.32, df = 2, 393, p = .01). During implementation, N = 431 parents were identified in 6 months (79.4% through the EHR item). CONCLUSION: Embedding parenting status screening into the EHR is feasible, accurate, and critical for linking parents with cancer to supportive care. Wider implementation of such workflows may enhance psychosocial oncology practice and improve cancer parenting outcomes.

24 Apr 2026

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Systematic ReviewEvidence: Moderate
75CEBM

European journal of pediatrics

Efficacy of physiotherapeutic interventions in the management of functional constipation in pediatric and adolescent populations: a systematic review and meta-analysis

UNLABELLED: To evaluate the efficacy of physiotherapeutic interventions in the management of functional constipation (FC) in pediatric and adolescent populations, and to analyze the methodological quality of the available evidence. A systematic review of randomized controlled trials (RCTs) published in PubMed, Cochrane Library, Embase, and Web of Science was conducted (February-March 2025). Studies including participants aged 18 years diagnosed with FC, treated with pelvic floor physiotherapy versus conventional medical treatment, were included. Methodological quality was assessed using the PEDro scale (Physiotherapy Evidence Database). Seven clinical trials were included in the meta-analysis with sample sizes ranging from 45 to 400 participants (total n = 775). The interventions covered pelvic floor exercises, biofeedback, telerehabilitation, visceral mobilization, and electrostimulation. The majority showed improvements in painful defecation, fecal consistency, and quality of life, with less consistent results in defecatory frequency (MD = 1.00; 95% CI: 0.35 to 1.65). However, the marked heterogeneity in protocols (type, intensity, duration), variability in assessment instruments, and frequent co-intervention with polyethylene glycol (PEG) hinder comparison between studies and limit external validity. Follow-ups shorter than 12 months and the absence of blinding of participants and therapists constitute additional risks of bias. CONCLUSIONS: Pelvic floor physiotherapy appears to be a promising adjuvant intervention in the treatment of pediatric FC, with positive effects on symptoms and quality of life. Nevertheless, multicenter trials with standardized protocols, large samples, and prolonged follow-up are required to confirm its efficacy and long-term sustainability. WHAT IS KNOWN: •Despite the clinical use of physiotherapy, there was no quantitative synthesis integrating its efficacy against standard medical treatment, nor had its specific effect size on defecatory pain and quality of life been established in the pediatric population. WHAT IS NEW: •This meta-analysis confi rms that pelvic fl oor physiotherapy is an eff ective adjuvant with a large effect size, demonstrating consistent improvements in reducing painful defecation and enhancing the biopsychosocial dimensions of quality of life.

12 Apr 2026

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otherEvidence: Moderate
70CEBM

JMIR formative research

Real-World Data From a Group Parent Management Training Program Enhanced Using Artificial Intelligence: Qualitative Study

BACKGROUND: Parent management training (PMT) is an evidence-based intervention for children with disruptive behavior problems. However, access to care is often limited by cost, availability of clinicians, scheduling, and transportation barriers. Integrating artificial intelligence (AI) into group PMT may improve accessibility, personalization, and adherence, while preserving therapeutic quality. OBJECTIVE: This study explored caregivers' experiences with a hybrid PMT program that combined live therapist-led group sessions with asynchronous support from Pat, an AI conversational agent designed to augment the therapists' support to caregivers. METHODS: A total of 88 caregivers of children aged 3-14 years (mean 7.98, SD 2.45 years) from Argentina and Paraguay participated in eight weekly online group sessions led by human therapists and supplemented by Pat. Caregivers were asked to provide the net promoter score (NPS) and their perceived contribution of their experience in remote group sessions and with Pat. Caregiver perspectives were analyzed using thematic analysis by multiple coders with consensus and interrater reliability assessment. RESULTS: The average NPS was 76.92, indicating excellent satisfaction. Regarding participants' perceptions of the overall program, the most frequent theme was useful strategies (73/202, 36.1%), reflecting the value placed on clear, structured, and practical tools to address everyday parenting challenges. Most comments about Pat were positive (156/164, 95.1%), particularly highlighting its 24/7 accessibility and constant availability (69/164, 42.1%). Recommendations for improvement mainly focused on enhancing the user experience and incorporating additional functionalities. Regarding perceived contribution to progress, caregivers attributed, on average, 61% to Pat and 46% to the group sessions. CONCLUSIONS: Combining therapist-led PMT group sessions with AI support appears feasible, acceptable, and valued by caregivers and may expand reach without sacrificing quality. Overall, caregivers valued the useful strategies and the professional and peer support and reported positive changes. Regarding Pat, the most valued aspect is the constant and immediate support. This model integrates human expertise with the accessibility and continuity provided by AI, reducing barriers, such as time, cost, and clinician availability.

8 Apr 2026

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Randomised Controlled TrialEvidence: Moderate
60CEBM

PloS one

Caregivers' early stimulation behaviors on early child development outcomes in Northern Ghana

Despite the government prioritizing Early Childhood Development (ECD) in Ghana, data on responsive caregiving is limited. This study examined the type and extent of Early Stimulation Activities (ESAs) practiced by mothers, and other caregivers and the associations between ESAs and children's development by caregiver type in Northern Ghana. Data were from a cluster-randomized controlled trial with mother-child dyads that evaluated the impact of an integrated maternal mental health and early childhood intervention program. The primary outcome was measured by the Developmental Milestone Checklist (DMC-II). Covariates included maternal report of ESAs performed by herself, child's father, and other caregivers. Linear regression analyses with cluster-adjusted standard errors were performed. Nearly 15% of mother-participants (n = 313) reported 4 + ESAs in the past 3 days. Within the last 3 days, on average, women reported 2.5 activities for themselves, 1.2 activities by the child's father, and 2 activities by other caregivers. The associations between ESAs and children's development varied by caregiver type. Maternal stimulation was positively associated with children's total development and personal-social development, early stimulation by other caregivers was positively associated with children's total development and language development, and paternal stimulation was not associated with any development domain. Other associations included receipt of postnatal care and presence of household toys. While maternal stimulation seemed particularly important, findings regarding non-primary caregivers suggest that ECD programming could also benefit from their inclusion.

5 Apr 2026

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Systematic ReviewEvidence: Moderate
70CEBM

BMJ paediatrics open

Impact of parent education programmes on confidence and self-efficacy in parents of preterm infants: a systematic review

OBJECTIVE: Families of preterm infants can experience high stress during neonatal intensive care unit (NICU) hospitalisation, which interferes with the development of parenting confidence and self-efficacy through active engagement with their infants. Parent NICU support programmes provide guidance and education to build this connection. This systematic review examined the effects of parent education programmes on confidence and self-efficacy among parents of preterm infants. DESIGN: Systematic review in PubMed/Medline, PsycINFO, CINAHL, Google Scholar and Web of Science. SETTING: NICU. PARTICIPANTS: Parents of preterm infants. INTERVENTION: Education programmes offered to parents in the NICU. MAIN OUTCOME MEASURES: Quantitative surveys measuring parent confidence or self-efficacy. RESULTS: 14 studies met inclusion criteria from an initial 220 identified. Five were randomised controlled trials and nine were non-randomised studies. Programmes combining information delivery with opportunities for parent-infant engagement were most effective. Infant access and time to practise skills were key factors in transferring programme knowledge to increase parent confidence and self-efficacy. While 6 of the 14 studies did not show statistically significant differences between groups, all interventions demonstrated improvements in parental confidence or self-efficacy from baseline. Vast variability in duration of intervention, proper descriptions of facilitator trainings, methodological limitations and potential confounding factors reduced the overall quality of evidence to a low level. CONCLUSION: Both unit-specific programmes developed within individual NICUs and commercially available, copyrighted parent education programmes hold value. They are generally effective in building parent confidence and self-efficacy among parents of preterm infants. Integrating either type of programme into standard NICU care may hold promise for strengthening parental competence and promoting family-centred outcomes. Clarity on content/topics of programmes, duration and level of facilitator trainings can strengthen the process of supporting parents in the NICU, even in low resource settings. PROSPERO REGISTRATION NUMBER: CRD42024524063.

4 Apr 2026

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