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BMJ Open May 2024To assess the reporting and methodological quality of early-life policy intervention papers that applied difference-in-differences (DiD) analysis.
OBJECTIVES
To assess the reporting and methodological quality of early-life policy intervention papers that applied difference-in-differences (DiD) analysis.
STUDY DESIGN
Systematic review.
DATA SOURCES
Papers applying DiD of early-life policy interventions in high-income countries as identified by searching Medline, Embase and Scopus databases up to December, 2022.
STUDY ELIGIBILITY CRITERIA, PARTICIPANTS AND INTERVENTIONS
Studies evaluating policy interventions targeting expectant mothers, infants or children up to two years old and conducted in high income countries were included. We focused on seven critical conditions of DiD as proposed in a comprehensive checklist: data requirements, parallel trends, no-anticipation, standard statistical assumptions, common shocks, group composition and spillover.
RESULTS
The DiD included studies (n=19) evaluating early-life policy interventions in childhood development (n=4), healthcare utilisation and providers (n=4), nutrition programmes (n=3) and economic policies such as prenatal care expansion (n=8). Although none of the included studies met all critical conditions, the most reported and adhered to critical conditions were data requirements (n=18), standard statistical assumptions (n=11) and the parallel trends assumption (n=9). No-anticipation and spillover were explicitly reported and adhered to in two studies and one study, respectively.
CONCLUSIONS
This review highlights current deficiencies in the reporting and methodological quality of studies using DiD to evaluate early-life policy interventions. As the validity of study conclusions and consequent implications for policy depend on the extent to which critical conditions are met, this shortcoming is concerning. We recommend that researchers use the described checklist to improve the transparency and validity of their evaluations. The checklist should be further refined by adding order of importance or knock-out criteria and may also help facilitate uniform terminology. This will hopefully encourage reliable DiD evaluations and thus contribute to better policies relating to expectant mothers, infants and children.
Topics: Humans; Infant; Health Policy; Infant, Newborn; Child, Preschool; Child Development; Female; Prenatal Care
PubMed: 38760036
DOI: 10.1136/bmjopen-2024-083927 -
Journal of Neuromuscular Diseases May 2024More than 200 clinical trials have been performed worldwide in ALS so far, but no agents with substantial efficacy on disease progression have been found. (Review)
Review
BACKGROUND
More than 200 clinical trials have been performed worldwide in ALS so far, but no agents with substantial efficacy on disease progression have been found.
OBJECTIVE
To describe the methodological quality of all clinical trials performed in ALS and published before December 31, 2022.
METHODS
We conducted a systematic review following the Preferred Reporting Items for Systematic Reviews and Meta Analyses.
RESULTS
213 trials were included. 47.4% manuscripts described preclinical study evaluation, with a positive effect in all. 67.6% of trials were conducted with a parallel-arm design, while 12.7% were cross-over studies; 77% were randomized, while in 5.6% historical-controls were used for comparison. 70% of trials were double blind. Participant inclusion allowed forced vital capacity (or corresponding slow vital capacity)<50% in 15% cases, between 55-65% in 21.6%, between 70-80% in 14.1% reports, and 49.3% of the evaluated manuscripts did not provide a minimum value for respiratory capacity at inclusion. Disease duration was < 6-months in 6 studies, 7-36 months in 68, 37-60 months in 24, 8 trials requested more than 1-month of disease duration, while in 107 reports a disease duration was not described. Dropout rate was ≥20% in 30.5% trials, while it was not reported for 8.5% .
CONCLUSION
The methodological quality of the included studies was highly variable. Major issues to be addressed in future ALS clinical trials include: the requirement for standard animal toxicology and phase I studies, the resource-intensive nature of phase II-III studies, adequate study methodology and design, a good results reporting.
PubMed: 38759021
DOI: 10.3233/JND-230217 -
Nutrition Reviews May 2024Seaweed is a promising source of anti-obesity agents, including polysaccharides, proteins, polyphenols, carotenoids, and n-3 long-chain polyunsaturated fatty acids. The...
CONTEXT
Seaweed is a promising source of anti-obesity agents, including polysaccharides, proteins, polyphenols, carotenoids, and n-3 long-chain polyunsaturated fatty acids. The anti-obesity effects of such compounds may be due to several mechanisms, including inhibition of lipid absorption and metabolism, effect on satiety, and inhibition of adipocyte differentiation.
OBJECTIVE
The aim of this study was to assess the evidence from human randomized controlled trials for the effects of seaweed on body-weight status as well as lipid and nonlipid parameters in adults with overweight and obesity.
DATA SOURCES
Four databases-Medline, Scopus, Web of Science, and Cochrane Library-were searched from December 2022 to June 2023 using the following key words: Seaweed OR fucoxanthin OR alginates OR fucoidans OR phlorotannin's OR macroalgae OR marine algae AND obesity OR overweight OR BMI OR body mass index.
DATA EXTRACTION
Eleven interventional studies (10 parallel and 1 crossover) were extracted.
DATA ANALYSIS
Meta-analysis showed a significant effect, favoring the intervention group for BMI (body mass index) (standardized mean difference [SMD]: -0.40; 95% CI: -0.65 to -0.16 kg/m2; P = 0.0013) and percentage of fat mass (SMD: -1.48; 95% CI: -2.66% to -0.30%, P = 0.0138). The results were seen when refined or extracted brown seaweed (BMI) or only refined brown seaweed (% fat mass) were administered to participants for at least 8 weeks. Moreover, a significant overall effect of seaweed supplementation on total cholesterol (SMD: -7.72; 95% CI: -12.49 to -2.95 mg/dL; P = 0.0015) and low-density-lipoprotein cholesterol (SMD: -7.33; 95% CI: -11.64 to -3.02 mg/dL; P < 0.001) was noted. Any significant effects of seaweed on glucose metabolism were not shown.
CONCLUSION
Edible seaweed supplementation shows potential for managing obesity and disorders of the blood lipid profile when administered to participants for at least 8 weeks.
SYSTEMATIC REVIEW REGISTRATION
PROSPERO registration no. CRD42022378484 (www.crd.york.ac.uk/PROSPERO).
PubMed: 38749056
DOI: 10.1093/nutrit/nuae042 -
International Journal of Nursing... Dec 2023Negative symptoms, frequently experienced by people with schizophrenia, can impair functional outcomes and quality of life. Negative symptoms typically affect... (Review)
Review
BACKGROUND
Negative symptoms, frequently experienced by people with schizophrenia, can impair functional outcomes and quality of life. Negative symptoms typically affect motivation, communication, and the ability to live independently and are difficult to treat. Several meta-analyses suggest that cognitive behavioural therapy results in a modest reduction in negative symptoms. It is unclear if similar effects can be achieved using behavioural activation. Behavioural activation is a derivative of cognitive behavioural therapy that helps to improve social and emotional functioning by encouraging patients to engage in activities that they value whilst modifying the avoidance responses. Behavioural activation can be a standalone treatment for depressive symptoms that is equally as efficacious as cognitive behavioural therapy.
OBJECTIVE
This systematic review aimed to identify and summarise the evidence about the efficacy of behavioural activation in treating negative symptoms.
DESIGN
Systematic review.
SETTING/PARTICIPANTS
Two published studies conducted in South Korea and the United Kingdom recruited 55 patients.
METHOD
We searched five databases and four trial registries for clinical treatment trials of behavioural activation involving adults diagnosed with negative symptoms of schizophrenia. Studies were screened according to the inclusion criteria and assessed for quality.
RESULTS
We identified 5023 published studies. After removing duplicates and conducting screening, two studies were included in this review. One study used a parallel non-randomised trial design whilst the other adopted a single group test-re-test design. Fifty-five participants were recruited from hospital and community settings. Both studies delivered 10 face-to-face sessions of behavioural activation; these were individual in one study and group sessions in the other. One study involved behavioural activation as the treatment whilst the other delivered behavioural activation with motivational interviewing. Neither study reported harms or adverse events.
CONCLUSIONS
Based on the included studies, there is low-quality evidence that behavioural activation may be helpful in the treatment of negative symptoms. Key limitations of the studies include small sample sizes and overall low study quality.
STUDY REGISTRATION
The protocol covering this review was registered with Open Science on 18 February 2022 (Registration DOI 10.17605/OSF.IO/57QSW; Weblink: https://osf.io/57qsw).
TWEETABLE ABSTRACT
Behavioural activation holds promise in supporting patients experiencing negative symptoms of schizophrenia.
PubMed: 38746587
DOI: 10.1016/j.ijnsa.2023.100132 -
The Cochrane Database of Systematic... May 2024In breast cancer screening programmes, women may have discussions with a healthcare provider to help them decide whether or not they wish to join the breast cancer... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
In breast cancer screening programmes, women may have discussions with a healthcare provider to help them decide whether or not they wish to join the breast cancer screening programme. This process is called shared decision-making (SDM) and involves discussions and decisions based on the evidence and the person's values and preferences. SDM is becoming a recommended approach in clinical guidelines, extending beyond decision aids. However, the overall effect of SDM in women deciding to participate in breast cancer screening remains uncertain.
OBJECTIVES
To assess the effect of SDM on women's satisfaction, confidence, and knowledge when deciding whether to participate in breast cancer screening.
SEARCH METHODS
We searched the Cochrane Breast Cancer Group's Specialised Register, CENTRAL, MEDLINE, Embase, CINAHL, PsycINFO, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform on 8 August 2023. We also screened abstracts from two relevant conferences from 2020 to 2023.
SELECTION CRITERIA
We included parallel randomised controlled trials (RCTs) and cluster-RCTs assessing interventions targeting various components of SDM. The focus was on supporting women aged 40 to 75 at average or above-average risk of breast cancer in their decision to participate in breast cancer screening.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed studies for inclusion and conducted data extraction, risk of bias assessment, and GRADE assessment of the certainty of the evidence. Review outcomes included satisfaction with the decision-making process, confidence in the decision made, knowledge of all options, adherence to the chosen option, women's involvement in SDM, woman-clinician communication, and mental health.
MAIN RESULTS
We identified 19 studies with 64,215 randomised women, mostly with an average to moderate risk of breast cancer. Two studies covered all aspects of SDM; six examined shortened forms of SDM involving communication on risks and personal values; and 11 focused on enhanced communication of risk without other SDM aspects. SDM involving all components compared to control The two eligible studies did not assess satisfaction with the SDM process or confidence in the decision. Based on a single study, SDM showed uncertain effects on participant knowledge regarding the age to start screening (risk ratio (RR) 1.18, 95% confidence interval (CI) 0.61 to 2.28; 133 women; very low certainty evidence) and frequency of testing (RR 0.84, 95% CI 0.68 to 1.04; 133 women; very low certainty evidence). Other review outcomes were not measured. Abbreviated forms of SDM with clarification of values and preferences compared to control Of the six included studies, none evaluated satisfaction with the SDM process. These interventions may reduce conflict in the decision made, based on two measures, Decisional Conflict Scale scores (mean difference (MD) -1.60, 95% CI -4.21 to 0.87; conflict scale from 0 to 100; 4 studies; 1714 women; very low certainty evidence) and the proportion of women with residual conflict compared to control at one to three months' follow-up (rate of women with a conflicted decision, RR 0.75, 95% CI 0.56 to 0.99; 1 study; 1001 women, very low certainty evidence). Knowledge of all options was assessed through knowledge scores and informed choice. The effect of SDM may enhance knowledge (MDs ranged from 0.47 to 1.44 higher scores on a scale from 0 to 10; 5 studies; 2114 women; low certainty evidence) and may lead to higher rates of informed choice (RR 1.24, 95% CI 0.95 to 1.63; 4 studies; 2449 women; low certainty evidence) compared to control at one to three months' follow-up. These interventions may result in little to no difference in anxiety (MD 0.54, 95% -0.96 to 2.14; scale from 20 to 80; 2 studies; 749 women; low certainty evidence) and the number of women with worries about cancer compared to control at four to six weeks' follow-up (RR 0.88, 95% CI 0.73 to 1.06; 1 study, 639 women; low certainty evidence). Other review outcomes were not measured. Enhanced communication about risks without other SDM aspects compared to control Of 11 studies, three did not report relevant outcomes for this review, and none assessed satisfaction with the SDM process. Confidence in the decision made was measured by decisional conflict and anticipated regret of participating in screening or not. These interventions, without addressing values and preferences, may result in lower confidence in the decision compared to regular communication strategies at two weeks' follow-up (MD 2.89, 95% CI -2.35 to 8.14; Decisional Conflict Scale from 0 to 100; 2 studies; 1191 women; low certainty evidence). They may result in higher anticipated regret if participating in screening (MD 0.28, 95% CI 0.15 to 0.41) and lower anticipated regret if not participating in screening (MD -0.28, 95% CI -0.42 to -0.14). These interventions increase knowledge (MD 1.14, 95% CI 0.61 to 1.62; scale from 0 to 10; 4 studies; 2510 women; high certainty evidence), while it is unclear if there is a higher rate of informed choice compared to regular communication strategies at two to four weeks' follow-up (RR 1.27, 95% CI 0.83 to 1.92; 2 studies; 1805 women; low certainty evidence). These interventions result in little to no difference in anxiety (MD 0.33, 95% CI -1.55 to 0.99; scale from 20 to 80) and depression (MD 0.02, 95% CI -0.41 to 0.45; scale from 0 to 21; 2 studies; 1193 women; high certainty evidence) and lower cancer worry compared to control (MD -0.17, 95% CI -0.26 to -0.08; scale from 1 to 4; 1 study; 838 women; high certainty evidence). Other review outcomes were not measured.
AUTHORS' CONCLUSIONS
Studies using abbreviated forms of SDM and other forms of enhanced communications indicated improvements in knowledge and reduced decisional conflict. However, uncertainty remains about the effect of SDM on supporting women's decisions. Most studies did not evaluate outcomes considered important for this review topic, and those that did measured different concepts. High-quality randomised trials are needed to evaluate SDM in diverse cultural settings with a focus on outcomes such as women's satisfaction with choices aligned to their values.
Topics: Adult; Aged; Female; Humans; Middle Aged; Breast Neoplasms; Decision Making, Shared; Early Detection of Cancer; Mammography; Patient Participation; Patient Satisfaction; Randomized Controlled Trials as Topic
PubMed: 38726892
DOI: 10.1002/14651858.CD013822.pub2 -
Phytotherapy Research : PTR May 2024In recent years, an increase in the incidence of liver diseases has been reported all over the world. This study aims to comprehensively summarize and quantitatively... (Review)
Review
Effect of grape-derived products on the serum levels of enzymes mainly produced by the liver: A systematic review and meta-analysis of parallel randomized controlled trials.
In recent years, an increase in the incidence of liver diseases has been reported all over the world. This study aims to comprehensively summarize and quantitatively analyze the existing evidence concerning the effectiveness of grape-derived products on liver enzymes through a systematic review and meta-analytic approach. PubMed, Scopus, Cochrane Library, and ISI Web of Science were comprehensively searched until January 2024. Articles that reported the effect of grape-derived products on serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) levels were included. Weighted mean differences (WMDs) were pooled using a random-effects model. Nine studies were included in the meta-analysis. The results revealed that grape-derived products did not significantly change the concentrations of ALT (WMD: -2.70 IU/L, 95% CI: -6.14 to 0.75, p = 0.12), and AST (WMD: -1.42 IU/L, 95% CI: -3.54 to 0.70, p = 0.18). However, a significant reduction was observed in serum ALP levels (WMD: -5.49 IU/L, 95% CI: -9.57 to -1.4, p = 0.008). The present findings suggest that grape-derived products positively influence serum ALP levels among adults. However, a more comprehensive decision necessitates additional studies.
PubMed: 38719548
DOI: 10.1002/ptr.8226 -
Clinical and Translational Science May 2024No systematic review of trial designs in patients with relapsing multiple sclerosis (RMS) was reported. This systematic review was conducted on the trial designs and... (Review)
Review
No systematic review of trial designs in patients with relapsing multiple sclerosis (RMS) was reported. This systematic review was conducted on the trial designs and primary end points (PEs) of phase II and III trials intended to modify the natural course of the disease in patients with RMS. The purpose of the study is to explore trends/topics and discussion points in clinical trial design and PE, comparing them to regulatory guidelines and expert recommendations. Three trial registration systems, ClinicalTrials.gov, the EU Clinical Trials Register, and the Japan Registry of Clinical Trials, were used and 60 trials were evaluated. The dominant clinical trial design was a randomized controlled parallel-arms trial and other details were as follows: in adult phase III confirmatory trials (n = 32), active-controlled double-blind trial (DBT) (53%) and active-controlled open-label assessor-masking trial (16%); in adult phase II dose-finding trials (n = 9), placebo- and active-controlled DBT (44%), placebo-controlled DBT (22%), and placebo-controlled add-on DBT (22%); and in pediatric phase III confirmatory trials (n = 8), active-controlled DBT (38%) and active-controlled open-label non-masking trial (25%). The most common PEs were as follows: in adult confirmatory trials, annual relapse rate (ARR) (56%) and no evidence of disease activity-3 (NEDA-3) (13%); in adult dose-finding trials, the cumulative number of T1 gadolinium-enhancing lesions (56%), combined unique active lesions (22%), and overall disability response score (22%); and in pediatric confirmatory trials, ARR (38%) and time to first relapse (25%). It was suggested that some parts of the regulatory guidelines and expert recommendations need to be revised.
Topics: Humans; Clinical Trials, Phase III as Topic; Clinical Trials, Phase II as Topic; Adult; Multiple Sclerosis, Relapsing-Remitting; Child; Research Design; Endpoint Determination; Randomized Controlled Trials as Topic
PubMed: 38708586
DOI: 10.1111/cts.13794 -
Clinical Oral Investigations May 2024The primary objective of this review is to compare autogenous soft tissue grafts (connective tissue graft - CTG and free gingival graft-FGG) with different type of... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
The primary objective of this review is to compare autogenous soft tissue grafts (connective tissue graft - CTG and free gingival graft-FGG) with different type of matrices (acellular dermal matrix-ADM, xenograft collagen matrix-XCM, volume-stable collagen matrix-VCMX) used to increase peri-implant soft tissues.
MATERIALS AND METHODS
A search on electronic databases was performed to identify randomized and non-randomized controlled trials (RCTs and CCTs, respectively) with either parallel or split-mouth design, and treating ≥ 10 patients. A network meta-analysis (NMA) was used to compare different matrices. Soft tissue thickness dimensional changes and keratinized width (KMW) changes were the primary outcome measures. The secondary outcomes were to evaluate: a) PROMs; b) volumetric changes; c) surgical operating time; and d) different periodontal measurements.
RESULTS
A total of 23 studies were included in the qualitative analysis, and 16 studies (11 RCTs and 5 CCTs) in the quantitative analysis. A total of N = 573 sites were evaluated for NMA. CTG resulted the best material for increasing peri-implant soft tissue thickness, at 180 and 360 days after surgery. The use of an ADM showed good results for buccal thickness increase, primarily in the first three months after surgery. Vestibuloplasty + FGG resulted in the most effective technique for peri-implant KMW augmentation, after 180 days.
CONCLUSIONS
While CTG demonstrated better performance in all the comparison and FGG showed to be the best graft to increase keratinized mucosa up to 90 days, ADM and VCMX may be used to increase soft tissue horizontal thickness with lower patients' morbidity.
LIMITATIONS
The limits of this NMA are the following: a) limited number of included studies; b) high heterogeneity among them (number of patients, treatment sites, surgical techniques, outcome measures, and follow-ups).
CLINICAL RELEVANCE
Many studies compared the efficacy of autogenous and non-autogenous grafts in terms of gingival thickness, volume, and keratinized width increase. However, there is still not clear overall evidence on this topic. This NMA helps clinicians to choose the right material in different peri-implant soft tissue procedures. Recommendations for future studies are mandatory.
Topics: Humans; Collagen; Network Meta-Analysis; Gingiva; Acellular Dermis; Connective Tissue; Dental Implants; Gingivoplasty
PubMed: 38704784
DOI: 10.1007/s00784-024-05684-5 -
BMC Oral Health May 2024Successful endodontic treatment needs accurate determination of working length (WL). Electronic apex locators (EALs) were presented as an alternative to radiographic... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Successful endodontic treatment needs accurate determination of working length (WL). Electronic apex locators (EALs) were presented as an alternative to radiographic methods; and since then, they have evolved and gained popularity in the determination of WL. However, there is insufficient evidence on the post-operative pain, adequacy, and accuracy of EALs in determining WL.
OBJECTIVE
The systematic review and meta-analysis aims to gather evidence regarding the effectiveness of EALs for WL determination when compared to different imaging techniques along with postoperative pain associated with WL determination, the number of radiographs taken during the procedure, the time taken, and the adverse effects.
METHODS
For the review, clinical studies with cross-over and parallel-arm randomized controlled trials (RCTs) were searched in seven electronic databases, followed by cross-referencing of the selected studies and related research synthesis. Risk of bias (RoB) assessment was carried out with Cochrane's RoB tool and a random-effects model was used. The meta-analysis was performed with the RevMan software 5.4.1.
RESULTS
Eleven eligible RCTs were incorporated into the review and eight RCTs into the meta-analysis, of which five had high RoB and the remaining six had unclear RoB. Following meta-analysis, no significant difference in postoperative pain was found among the EAL and radiograph groups (SMD 0.00, CI .29 to .28, 354 participants; P value = 0.98). Radiograph group showed better WL accuracy (SMD 0.55, CI .11 to .99, 254 participants; P value = 0.02), while the EAL group had 10% better WL adequacy (RR 1.10, CI 1.03-1.18, 573 participants; P value = 0.006).
CONCLUSION
We found very low-certainty evidence to support the efficacy of different types of EAL compared to radiography for the outcomes tested. We were unable to reach any conclusions about the superiority of any type of EAL. Well-planned RCTs need to be conducted by standardizing the outcomes and outcome measurement methods.
Topics: Humans; Dental Pulp Cavity; Odontometry; Radiography, Dental; Tooth Apex
PubMed: 38704529
DOI: 10.1186/s12903-024-04259-w -
La Medicina Del Lavoro Apr 2024Several antiblastic drugs (ADs) are classified as carcinogenic, mutagenic, and/or toxic for reproduction. Despite established guidelines and safe handling technologies,...
Several antiblastic drugs (ADs) are classified as carcinogenic, mutagenic, and/or toxic for reproduction. Despite established guidelines and safe handling technologies, ADs contamination of the work environments could occur in healthcare settings, leading to potential exposure of healthcare staff. This systematic review aims to investigate the main techniques and practices for assessing ADs occupational exposure in healthcare settings. The reviewed studies unveil that workplace contamination by ADs appears to be a still-topical problem in healthcare settings. These issues are linked to difficulties in guaranteeing: (i) the adherence to standardized protocols when dealing with ADs, (ii) the effective use of personal protective equipment by operators involved in the administration or management of ADs, (iii) a comprehensive training of the healthcare personnel, and (iv) a thorough health surveillance of exposed workers. A "multi-parametric" approach emerges as a desirable strategy for exposure assessment. In parallel, exposure assessment should coincide with the introduction of novel technologies aimed at minimizing exposure (i.e., risk management). Assessment must consider various departments and health operators susceptible to ADs contamination, with a focus extended beyond worst-case scenarios, also considering activities like surface cleaning and logistical tasks related to ADs management. A comprehensive approach in ADs risk assessment enables the evaluation of distinct substance behaviors and subsequent exposure routes, affording a more holistic understanding of potential risks.
Topics: Humans; Occupational Exposure; Risk Assessment; Health Personnel; Drug Compounding; Personal Protective Equipment; Health Facilities
PubMed: 38686575
DOI: 10.23749/mdl.v115i2.15609