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Women's Health Reports (New Rochelle,... 2022The objective of this study was to evaluate the extent, type, and severity of spin in randomized controlled trials (RCTs) in obstetrics and gynecology. (Review)
Review
OBJECTIVES
The objective of this study was to evaluate the extent, type, and severity of spin in randomized controlled trials (RCTs) in obstetrics and gynecology.
DATA SOURCES
The top five highest impact journals in obstetrics and gynecology were systematically searched for RCTs with non-significant primary outcomes published between January 1, 2019, and December 31, 2020.
METHODS
Study selection and data extraction assessment were conducted independently and in duplicate. The extent, type, and severity of spin was identified and reported with previously established methodology, and risk of bias was assessed with the Cochrane Risk-of-Bias 2 Tool independently and in duplicate. Fisher's exact tests were used to evaluate the association between study characteristics, risk of bias, and spin.
RESULTS
We identified 1475 publications, of which 59 met our inclusion criteria. Articles evaluated interventions in obstetrics ( = 37, 63%) and gynecology ( = 22, 37%). Spin was not detected in 28 (47%) of the articles: Three (5%) had one, 10 (17%) had two, and 18 (31%) had greater than two occurrences of spin. Compared with articles where no spin was detected, spin was associated with the Cochrane Risk-of-Bias domain pertaining to missing data ( < 0.05). No association was observed with the journal, funding source, number of authors, types of interventions, and whether the study involved gynecology or obstetrics.
CONCLUSIONS
Spin was detected in nearly half of 1:1 parallel two-arm RCTs in obstetrics and gynecology, highlighting the need for caution in the interpretation of RCT findings, particularly when the primary outcome is nonsignificant.
PubMed: 36204479
DOI: 10.1089/whr.2021.0141 -
International Journal of Environmental... Nov 2023The COVID-19 pandemic and the accompanying social changes severely impacted mental health globally. Children and adolescents may have been vulnerable to adverse mental... (Review)
Review
The COVID-19 pandemic and the accompanying social changes severely impacted mental health globally. Children and adolescents may have been vulnerable to adverse mental health outcomes, especially obsessive-compulsive disorder (OCD), due to their underdeveloped resilience and coping skills stemming from their progressing physical and psychological development. Few studies have explored the parallels between the pandemic and OCD trends in this population. This systematic review aims to identify the impacts of COVID-19 on OCD among children and adolescents. Using the PRISMA guidelines, a systematic search of eight databases for studies that assessed OCD outcomes independently or as part of other psychiatric diagnoses during the COVID-19 pandemic was conducted. The search was limited to studies on humans and those written in English and published between January 2020 and May 2023. We identified 788 articles, out of which 71 were selected for a full-text review. Twenty-two papers were synthesized from 10 countries for the final analysis. We found that 77% of our studies suggested that the COVID-19 pandemic had a negative impact on OCD among children and adolescents. We also found a complex interplay of individual, household, and socio-structural factors associated with the aggravation of OCD. Conversely, a few studies revealed that the pandemic strengthened relationships and resilience. The findings of this study emphasize the need for mental health screening and support for this population, especially during pandemic periods.
Topics: Child; Humans; Adolescent; COVID-19; Pandemics; Obsessive-Compulsive Disorder; Mental Health
PubMed: 38063525
DOI: 10.3390/ijerph20237095 -
Family Medicine and Community Health Oct 2022Social prescribing is a person-centred model of care with emphases on lessening the impact of unmet social needs, supporting the delivery of personalised care, and...
OBJECTIVE
Social prescribing is a person-centred model of care with emphases on lessening the impact of unmet social needs, supporting the delivery of personalised care, and reducing non-medical resource use in the primary care setting. The purpose of this systematic review was to synthesise the effect of social prescribing for older adults within primary care.
DESIGN
We followed standard systematic review guidelines, including protocol registration, screening studies (title/abstract and full text) and assessing the study quality.
ELIGIBILITY AND INFORMATION SOURCES
We searched multiple online databases for studies that included older adults 60+ years (group mean age), an intervention defined and called social prescribing (or social prescription) via health provider referrals to non-medical services, and quantitative physical and psychosocial outcomes and/or health resource use. We included experimental and observational studies from all years and languages and conducted a narrative synthesis. The date of the last search was 24 March 2022.
RESULTS
We screened 406 citations (after removing duplicates) and included seven studies. All studies except one were before-after design without a control group, and all except one study was conducted in the UK. Studies included 12-159 participants (baseline), there were more women than men, the group mean (SD) age was 76.1 (4.0) years and data collection (baseline to final) occurred on average 19.4 (14.0) weeks apart. Social prescribing referrals came from health and social providers. Studies had considerable risk of bias, programme implementation details were missing, and for studies that reported data (n=6) on average only 66% of participants completed studies (per-protocol). There were some positive effects of social prescribing on physical and psychosocial outcomes (eg, social participation, well-being). Findings varied for health resource use. These results may change with new evidence.
CONCLUSIONS
There were few peer-reviewed studies available for social prescribing and older adults. Next steps for social prescribing should include co-creating initiatives with providers, older people and communities to identify meaningful outcomes, and feasible and robust methods for uptake of the prescription and community programmes. This should be considered in advance or in parallel with determining its effectiveness for meaningful outcomes at multiple levels (person, provider and programme).
Topics: Aged; Female; Humans; Male; Primary Health Care; Social Support
PubMed: 36207017
DOI: 10.1136/fmch-2022-001829 -
Journal of Functional Biomaterials Apr 2023The majority of patients strongly favor the use of aligners in the present time, especially with the advancement in esthetic dentistry. Today's market is flooded with... (Review)
Review
The majority of patients strongly favor the use of aligners in the present time, especially with the advancement in esthetic dentistry. Today's market is flooded with aligner companies, many of which share the same therapeutic ethos. We therefore carried out a systematic review and network meta-analysis to evaluate research that had looked at various aligner materials and attachments and their effect on orthodontic tooth movement in relevant studies. A total of 634 papers were discovered after a thorough search of online journals using keywords such as "Aligners", "Orthodontics", "Orthodontic attachments", "Orthodontic tooth movement", and "Polyethylene" across databases such as PubMed, Web of Science, and Cochrane. The authors individually and in parallel carried out the database investigation, removal of duplicate studies, data extraction, and bias risk. The statistical analysis demonstrated that the type of aligner material had a significant impact on orthodontic tooth movement. The low level of heterogeneity and significant overall effect further support this finding. However, there was little effect of attachment size or shape on tooth mobility. The examined materials were primarily concerned with influencing the physical/physicochemical characteristics of the appliances and not tooth movement directly. Invisalign (Inv) had a higher mean value than the other types of materials that were analyzed, which suggested a potentially greater impact on orthodontic tooth movement. However, its variance value indicated that there was also greater uncertainty associated with the estimate compared to some of the other plastics. These findings could have important implications for orthodontic treatment planning and aligner material selection. Registration: This review protocol was registered on the International Prospective Register of Systematic Reviews (PROSPERO; registration number: CRD42022381466).
PubMed: 37103299
DOI: 10.3390/jfb14040209 -
Clinical Oral Investigations Feb 2022By means of a systematic review and network meta-analysis, this study aims to answer the following questions: (a) does the placement of a biomaterial over an extraction... (Meta-Analysis)
Meta-Analysis Review
AIM
By means of a systematic review and network meta-analysis, this study aims to answer the following questions: (a) does the placement of a biomaterial over an extraction socket lead to better outcomes in terms of horizontal and vertical alveolar dimensional changes and percentage of new bone formation than healing without coverage? And (b) which biomaterial(s) provide(s) the better outcomes?
MATERIALS AND METHODS
Parallel and split-mouth randomized controlled trials treating ≥ 10 patients were included in this analysis. Studies were identified with MEDLINE (PubMed), Embase, Cochrane Central Register of Controlled Trials, and Scopus. Primary outcomes were preservation of horizontal and vertical alveolar dimension and new bone formation inside the socket. Both pairwise and network meta-analysis (NMA) were undertaken to obtain estimates for primary outcomes. For NMA, prediction intervals were calculated to estimate clinical efficacy, and SUCRA was used to rank the materials based on their performance; multidimensional ranking was used to rank treatments based on dissimilarity. The manuscript represents the proceedings of a consensus conference of the Italian Society of Osseointegration (IAO).
RESULTS
Twelve trials were included in the qualitative and quantitative analysis: 312 sites were evaluated. Autologous soft tissue grafts were associated with better horizontal changes compared to resorbable membranes. A statistically significant difference in favor of resorbable membranes, when compared to no membrane, was found, with no statistically significant heterogeneity. For the comparison between crosslinked and non-crosslinked membranes, a statistically significant difference was found in favor of the latter and confirmed by histomorphometric NMA analysis. Given the relatively high heterogeneity detected in terms of treatment approaches, materials, and outcome assessment, the findings of the NMA must be interpreted cautiously.
CONCLUSIONS
Coverage of the healing site is associated with superior results compared to no coverage, but no specific sealing technique and/or biomaterial provides better results than others. RCTs with larger sample sizes are needed to better elucidate the trends emerged from the present analysis.
CLINICAL RELEVANCE
Autologous soft tissue grafts and membranes covering graft materials in post-extraction sites were proved to allow lower hard tissue shrinkage compared to the absence of coverage material with sealing effect. Histomorphometric analyses showed that non-crosslinked membranes provide improved hard tissue regeneration when compared to crosslinked ones.
Topics: Alveolar Ridge Augmentation; Biocompatible Materials; Dental Care; Humans; Network Meta-Analysis; Randomized Controlled Trials as Topic; Tooth Extraction; Tooth Socket; Treatment Outcome; Wound Healing
PubMed: 34825280
DOI: 10.1007/s00784-021-04262-3 -
Particle and Fibre Toxicology Sep 2022The number of publications in the field of nanogenotoxicology and the amount of genotoxicity data on nanomaterials (NMs) in several databases generated by European Union... (Review)
Review
The number of publications in the field of nanogenotoxicology and the amount of genotoxicity data on nanomaterials (NMs) in several databases generated by European Union (EU) funded projects have increased during the last decade. In parallel, large research efforts have contributed to both our understanding of key physico-chemical (PC) parameters regarding NM characterization as well as the limitations of toxicological assays originally designed for soluble chemicals. Hence, it is becoming increasingly clear that not all of these data are reliable or relevant from the regulatory perspective. The aim of this systematic review is to investigate the extent of studies on genotoxicity of NMs that can be considered reliable and relevant by current standards and bring focus to what is needed for a study to be useful from the regulatory point of view. Due to the vast number of studies available, we chose to limit our search to two large groups, which have raised substantial interest in recent years: nanofibers (including nanotubes) and metal-containing nanoparticles. Focusing on peer-reviewed publications, we evaluated the completeness of PC characterization of the tested NMs, documentation of the model system, study design, and results according to the quality assessment approach developed in the EU FP-7 GUIDEnano project. Further, building on recently published recommendations for best practices in nanogenotoxicology research, we created a set of criteria that address assay-specific reliability and relevance for risk assessment purposes. Articles were then reviewed, the qualifying publications discussed, and the most common shortcomings in NM genotoxicity studies highlighted. Moreover, several EU projects under the FP7 and H2020 framework set the aim to collectively feed the information they produced into the eNanoMapper database. As a result, and over the years, the eNanoMapper database has been extended with data of various quality depending on the existing knowledge at the time of entry. These activities are highly relevant since negative results are often not published. Here, we have reviewed the NanoInformaTIX instance under the eNanoMapper database, which hosts data from nine EU initiatives. We evaluated the data quality and the feasibility of use of the data from a regulatory perspective for each experimental entry.
Topics: DNA Damage; Databases, Factual; Metal Nanoparticles; Nanostructures; Reproducibility of Results
PubMed: 36104711
DOI: 10.1186/s12989-022-00499-2 -
Neuropsychiatric Disease and Treatment 2023Suicide is a major public health concern with currently no validated and efficacious treatments approved. Preliminary evidence suggests that intravenous ketamine has... (Review)
Review
PURPOSE
Suicide is a major public health concern with currently no validated and efficacious treatments approved. Preliminary evidence suggests that intravenous ketamine has rapid and sustained antidepressant effects, making it a candidate with therapeutic potential for depressed patients at risk for suicide. We conducted a meta-analysis to evaluate the efficacy of ketamine and esketamine in reducing suicidal ideation (SI), as well as their respective onset and duration of action.
DATA SOURCES
We searched PubMed, Embase, Ovid, Cochrane, and Web of Science databases for studies published from inception to September 29, 2022.
STUDY ELIGIBILITY CRITERIA
We conducted a systematic review of all parallel randomized controlled trials (RCTs) examining the effect and duration of ketamine or esketamine on SI. Our primary outcome measure was the Suicide Scale score, which was measured using the Scale for Suicidal Ideation (SSI), Beck Scale for Suicide Ideation (BSS), Beck Depression Inventory (BDI), or Modified Scale for Suicidal Ideation (MSSI). To obtain effect sizes (Cohen's d), we calculated the difference in Suicide Scale scores before and after administration in each group.
RESULTS
Our study showed that intravenous sub-anesthetic doses of ketamine and intranasal inhaled esketamine had a significant anti-SI effect. Specifically, ketamine produced a large degree of anti-SI effect within the 4-6 hours (Cohen's d = 1.16, 95% CI: 0.50, 1.81) and a medium-large degree in the 24 hours (Cohen's d = 0.95, 95% CI: 0.48, 1.41). Esketamine, on the other hand, produced a small-medium degree of anti-SI effect within the 4-6 hours timeframe (Cohen's d = 0.26, 95% CI: 0.09, 0.44) and the 24 hours (Cohen's d = 0.30, 95% CI: 0.17, 0.47).
CONCLUSION
Intravenous sub-anesthetic doses of ketamine and intranasal inhaled esketamine could reduce SI within 4 hours and last for 24 hours.
PubMed: 36942150
DOI: 10.2147/NDT.S401032 -
Scientific Reports Aug 2023Asthma and chronic obstructive pulmonary disease (COPD) are prevalent chronic respiratory disorders that cause significant morbidity and mortality. Some studies... (Meta-Analysis)
Meta-Analysis
Asthma and chronic obstructive pulmonary disease (COPD) are prevalent chronic respiratory disorders that cause significant morbidity and mortality. Some studies evaluated the use of inhaled unfractionated heparin (UFH) in the treatment of asthma and COPD. We aimed to synthesize the available evidence for the efficacy and safety of inhaled heparin in improving lung functions among asthmatic and COPD patients. A comprehensive search was performed using Pubmed, Embase, EBSCO, Scopus, Web of Science, Cochrane CENTRAL, WHO Clinical trials, clinicaltrials.gov, Iranian Clinical trials, Google Scholar, Research Gate, ProQuest Thesis, OVID, and medRxiv databases. Two independent reviewers included all pertinent articles according to PRISMA guidelines, and extract data independently. The two reviewers checked the quality of studies using the ROB2 tool. To determine the pooled effect estimate of the efficacy and safety of inhaled heparin, a meta-analysis was carried out using the R programming language. Publication bias was evaluated using Egger's regression test. The heterogeneity was explained using a meta-regression, and the quality of evidence was assessed by the GRADE approach. Twenty-six studies with a total of 581 patients were included in the qualitative analysis and 16 in the meta-analysis. The primary outcome was treatment success (improvement of lung function) that was measured by standardized mean differences (SMD) of the forced expiratory volume per second (FEV1) either per ml or percentage. Heparin has a large effect on both FEV1% and FEV1 ml when compared to the control group (SMD 2.7, 95% CI 1.00; 4.39; GRADE high, SMD 2.12, 95% CI - 1.49; 5.72: GRADE moderate, respectively). Secondary outcomes are other lung functions improving parameters such as PC20 (SMD 0.91, 95% CI - 0.15; 1.96). Meta-regression and subgroup analysis show that heparin type, dose, year of publication, study design, and quality of studies had a substantial effect. Regarding safety, inhaled heparin showed a good coagulation profile and mild tolerable side effects. Inhaled heparin showed improvement in lung functions either alone or when added to standard care. More large parallel RCTs are needed including COPD patients, children, and other types, and stages of asthmatic patients.
Topics: Child; Humans; Heparin; Iran; Asthma; Pulmonary Disease, Chronic Obstructive; Databases, Factual
PubMed: 37587208
DOI: 10.1038/s41598-023-40489-8 -
Frontiers in Microbiology 2022Infectious diseases caused by antibiotic-resistant bacterial (ARB) pathogens are a serious threat to human and animal health. The active surveillance of ARB using an... (Review)
Review
Infectious diseases caused by antibiotic-resistant bacterial (ARB) pathogens are a serious threat to human and animal health. The active surveillance of ARB using an integrated one-health approach can help to reduce the emergence and spread of ARB, reduce the associated economic impact, and guide antimicrobial stewardship programs. Wastewater surveillance (WWS) of ARB provides composite samples for a total population, with easy access to the mixed community microbiome. This concept is emerging rapidly, but the clinical utility, sensitivity, and uniformity of WWS of ARB remain poorly understood especially in relation to clinical evidence in sewershed communities. Here, we systematically searched the literature to identify studies that have compared findings from WWS of ARB and antibiotic resistance genes (ARG) with clinical evidence in parallel, thereby evaluating how likely WWS of ARB and ARG can relate to the clinical cases in communities. Initially, 2,235 articles were obtained using the primary search keywords, and 1,219 articles remained after de-duplication. Among these, 35 articles fulfilled the search criteria, and an additional 13 relevant articles were included by searching references in the primary literature. Among the 48 included papers, 34 studies used a culture-based method, followed by 11 metagenomics, and three PCR-based methods. A total of 28 out of 48 included studies were conducted at the single sewershed level, eight studies involved several countries, seven studies were conducted at national or regional scales, and five at hospital levels. Our review revealed that the performance of WWS of ARB pathogens has been evaluated more frequently for spp., and other members of the family , but has not been uniformly tested for all ARB pathogens. Many wastewater-based ARB studies comparing the findings with clinical evidence were conducted to evaluate the public health risk but not to relate with clinical evidence and to evaluate the performance of WWS of ARB. Indeed, relating WWS of ARB with clinical evidence in a sewershed is not straightforward, as the source of ARB in wastewater cannot be only from symptomatic human individuals but can also be from asymptomatic carriers as well as from animal sources. Further, the varying fates of each bacterial species and ARG within the sewerage make the aim of connecting WWS of ARB with clinical evidence more complicated. Therefore, future studies evaluating the performance of many AMR pathogens and their genes for WWS one by one can make the process simpler and the interpretation of results easier.
PubMed: 36590429
DOI: 10.3389/fmicb.2022.977106 -
The Cochrane Database of Systematic... Feb 2023The term central sleep apnoea (CSA) encompasses diverse clinical situations where a dysfunctional drive to breathe leads to recurrent respiratory events, namely apnoea... (Review)
Review
BACKGROUND
The term central sleep apnoea (CSA) encompasses diverse clinical situations where a dysfunctional drive to breathe leads to recurrent respiratory events, namely apnoea (complete absence of ventilation) and hypopnoea sleep (insufficient ventilation) during sleep. Studies have demonstrated that CSA responds to some extent to pharmacological agents with distinct mechanisms, such as sleep stabilisation and respiratory stimulation. Some therapies for CSA are associated with improved quality of life, although the evidence on this association is uncertain. Moreover, treatment of CSA with non-invasive positive pressure ventilation is not always effective or safe and may result in a residual apnoea-hypopnoea index.
OBJECTIVES
To evaluate the benefits and harms of pharmacological treatment compared with active or inactive controls for central sleep apnoea in adults.
SEARCH METHODS
We used standard, extensive Cochrane search methods. The latest search date was 30 August 2022.
SELECTION CRITERIA
We included parallel and cross-over randomised controlled trials (RCTs) that evaluated any type of pharmacological agent compared with active controls (e.g. other medications) or passive controls (e.g. placebo, no treatment or usual care) in adults with CSA as defined by the International Classification of Sleep Disorders 3rd Edition. We did not exclude studies based on the duration of intervention or follow-up. We excluded studies focusing on CSA due to periodic breathing at high altitudes.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were central apnoea-hypopnoea index (cAHI), cardiovascular mortality and serious adverse events. Our secondary outcomes were quality of sleep, quality of life, daytime sleepiness, AHI, all-cause mortality, time to life-saving cardiovascular intervention, and non-serious adverse events. We used GRADE to assess certainty of evidence for each outcome.
MAIN RESULTS
We included four cross-over RCTs and one parallel RCT, involving a total of 68 participants. Mean age ranged from 66 to 71.3 years and most participants were men. Four trials recruited people with CSA associated with heart failure, and one study included people with primary CSA. Types of pharmacological agents were acetazolamide (carbonic anhydrase inhibitor), buspirone (anxiolytic), theophylline (methylxanthine derivative) and triazolam (hypnotic), which were given for between three days and one week. Only the study on buspirone reported a formal evaluation of adverse events. These events were rare and mild. No studies reported serious adverse events, quality of sleep, quality of life, all-cause mortality, or time to life-saving cardiovascular intervention. Carbonic anhydrase inhibitors versus inactive control Results were from two studies of acetazolamide versus placebo (n = 12) and acetazolamide versus no acetazolamide (n = 18) for CSA associated with heart failure. One study reported short-term outcomes and the other reported intermediate-term outcomes. We are uncertain whether carbonic anhydrase inhibitors compared to inactive control reduce cAHI in the short term (mean difference (MD) -26.00 events per hour, 95% CI -43.84 to -8.16; 1 study, 12 participants; very low certainty). Similarly, we are uncertain whether carbonic anhydrase inhibitors compared to inactive control reduce AHI in the short term (MD -23.00 events per hour, 95% CI -37.70 to 8.30; 1 study, 12 participants; very low certainty) or in the intermediate term (MD -6.98 events per hour, 95% CI -10.66 to -3.30; 1 study, 18 participants; very low certainty). The effect of carbonic anhydrase inhibitors on cardiovascular mortality in the intermediate term was also uncertain (odds ratio (OR) 0.21, 95% CI 0.02 to 2.48; 1 study, 18 participants; very low certainty). Anxiolytics versus inactive control Results were based on one study of buspirone versus placebo for CSA associated with heart failure (n = 16). The median difference between groups for cAHI was -5.00 events per hour (IQR -8.00 to -0.50), the median difference for AHI was -6.00 events per hour (IQR -8.80 to -1.80), and the median difference on the Epworth Sleepiness Scale for daytime sleepiness was 0 points (IQR -1.0 to 0.00). Methylxanthine derivatives versus inactive control Results were based on one study of theophylline versus placebo for CSA associated with heart failure (n = 15). We are uncertain whether methylxanthine derivatives compared to inactive control reduce cAHI (MD -20.00 events per hour, 95% CI -32.15 to -7.85; 15 participants; very low certainty) or AHI (MD -19.00 events per hour, 95% CI -30.27 to -7.73; 15 participants; very low certainty). Hypnotics versus inactive control Results were based on one trial of triazolam versus placebo for primary CSA (n = 5). Due to very serious methodological limitations and insufficient reporting of outcome measures, we were unable to draw any conclusions regarding the effects of this intervention.
AUTHORS' CONCLUSIONS
There is insufficient evidence to support the use of pharmacological therapy in the treatment of CSA. Although small studies have reported positive effects of certain agents for CSA associated with heart failure in reducing the number of respiratory events during sleep, we were unable to assess whether this reduction may impact the quality of life of people with CSA, owing to scarce reporting of important clinical outcomes such as sleep quality or subjective impression of daytime sleepiness. Furthermore, the trials mostly had short-term follow-up. There is a need for high-quality trials that evaluate longer-term effects of pharmacological interventions.
Topics: Male; Adult; Humans; Aged; Female; Sleep Apnea, Central; Carbonic Anhydrase Inhibitors; Buspirone; Apnea; Triazolam; Theophylline; Acetazolamide; Heart Failure; Hypnotics and Sedatives; Disorders of Excessive Somnolence
PubMed: 36861808
DOI: 10.1002/14651858.CD012922.pub2