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Neonatology 2023The 2015 recommendation of the International Liaison Committee on Resuscitation of no routine tracheal suctioning in non-vigorous neonates born through meconium-stained... (Meta-Analysis)
Meta-Analysis
Assessment of Change in Practice of Routine Tracheal Suctioning Approach of Non-Vigorous Infants Born through Meconium-Stained Amniotic Fluid: A Pragmatic Systematic Review and Meta-Analysis of Evidence outside Randomized Trials.
AIM
The 2015 recommendation of the International Liaison Committee on Resuscitation of no routine tracheal suctioning in non-vigorous neonates born through meconium-stained amniotic fluid (MSAF) was based on very low certainty of evidence (CoE) necessitating ongoing monitoring. The aim of this systematic review was to perform a meta-analysis of observational studies comparing the effect of implementing immediate resuscitation without routine tracheal suctioning versus with routine suctioning in neonates born through MSAF.
METHODS
MEDLINE, Embase, CENTRAL, and Web of Science were searched. Observational studies with a before-and-after design were included. Two authors extracted data independently. CoE based on GRADE recommendations was performed.
RESULTS
13 studies were included. Clinical benefit or harm could not be excluded for the composite primary outcome of mortality or requirement of extracorporeal membranous oxygenation (ECMO) (relative risk, 95% confidence interval: 0.74 [0.47-1.17]), and mortality (0.68 [0.42-1.11]). "Routine tracheal suctioning" epoch had possibly lesser risk of meconium aspiration syndrome (MAS) when compared to "no routine tracheal suctioning" epoch (0.68 [0.47-0.99]). "Routine tracheal suctioning" epoch also possibly had a lower risk of hospital admission for respiratory symptoms, requirement of non-invasive respiratory support, invasive mechanical ventilation, surfactant treatment, air leak, and low-flow oxygen therapy. Clinical benefit or harm could not be excluded for the outcome of mortality or ECMO among those diagnosed with MAS (1.09 [0.86-1.39]), but "routine tracheal suctioning" was possibly associated with lower risk of respiratory morbidities among those diagnosed with MAS. The CoE was very low for most of the outcomes evaluated.
CONCLUSIONS
Due to the very low CoE for the outcomes evaluated, no definitive conclusions can be drawn warranting the need for additional studies.
Topics: Female; Humans; Infant, Newborn; Infant; Meconium; Meconium Aspiration Syndrome; Amniotic Fluid; Randomized Controlled Trials as Topic; Respiration, Artificial; Observational Studies as Topic
PubMed: 36754038
DOI: 10.1159/000528715 -
Journal of the American Academy of... Jul 2023New evidence has emerged since the 2014 guidelines that further informs the management of atopic dermatitis (AD) with topical therapies. These guidelines update the 2014...
BACKGROUND
New evidence has emerged since the 2014 guidelines that further informs the management of atopic dermatitis (AD) with topical therapies. These guidelines update the 2014 recommendations for management of AD with topical therapies.
OBJECTIVE
To provide evidence-based recommendations related to management of AD in adults using topical treatments.
METHODS
A multidisciplinary workgroup conducted a systematic review and applied the GRADE (Grading of Recommendations, Assessment, Development, and Evaluations) approach for assessing the certainty of evidence and formulating and grading recommendations.
RESULTS
The workgroup developed 12 recommendations on the management of AD in adults with topical therapies, including nonprescription agents and prescription topical corticosteroids (TCS), calcineurin inhibitors (TCIs), Janus kinase (JAK) inhibitors, phosphodiesterase-4 inhibitors (PDE-4), antimicrobials, and antihistamines.
LIMITATIONS
The pragmatic decision to limit the literature review to English-language randomized trials may have excluded data published in other languages and relevant long-term follow-up data.
CONCLUSIONS
Strong recommendations are made for the use of moisturizers, TCIs, TCS, and topical PDE-4 and JAK inhibitors. Conditional recommendations are made for the use of bathing and wet wrap therapy and against the use of topical antimicrobials, antiseptics, and antihistamines.
Topics: Adult; Humans; Dermatitis, Atopic; Calcineurin Inhibitors; Dermatologic Agents; Administration, Topical; Glucocorticoids; Anti-Infective Agents, Local; Histamine Antagonists
PubMed: 36641009
DOI: 10.1016/j.jaad.2022.12.029 -
International Journal of Environmental... Dec 2022The main contributor to excess mortality in severe mental illness (SMI) is poor physical health. Causes include unfavorable health behaviors among people with SMI,... (Review)
Review
BACKGROUND
The main contributor to excess mortality in severe mental illness (SMI) is poor physical health. Causes include unfavorable health behaviors among people with SMI, stigmatization phenomena, as well as limited access to and utilization of physical health care. Patient centered interventions to promote the utilization of and access to existing physical health care facilities may be a pragmatic and cost-effective approach to improve health equity in this vulnerable and often neglected patient population.
OBJECTIVE/METHODS
In this study, we systematically reviewed the international literature on such studies (sources: literature databases, trial-registries, grey literature). Empirical studies (quantitative, qualitative, and mixed methods) of interventions to improve the utilization of and access to medical health care for people with a SMI, were included.
RESULTS
We identified 38 studies, described in 51 study publications, and summarized them in terms of type, theoretical rationale, outcome measures, and study author's interpretation of the intervention success.
CONCLUSIONS
Useful interventions to promote the utilization of physical health care for people with a SMI exist, but still appear to be rare, or at least not supplemented by evaluation studies. The present review provides a map of the evidence and may serve as a starting point for further quantitative effectiveness evaluations of this promising type of behavioral intervention.
Topics: Humans; Mental Disorders; Outcome Assessment, Health Care; Behavior Therapy; Empirical Research; Health Equity
PubMed: 36612457
DOI: 10.3390/ijerph20010126 -
The Cochrane Database of Systematic... Jan 2023Diabetic kidney disease (DKD) continues to be the leading cause of kidney failure across the world. For decades dietary protein restriction has been proposed for... (Review)
Review
BACKGROUND
Diabetic kidney disease (DKD) continues to be the leading cause of kidney failure across the world. For decades dietary protein restriction has been proposed for patients with DKD with the aim to retard the progression of chronic kidney disease (CKD) towards kidney failure. However, the relative benefits and harms of dietary protein restriction for slowing the progression of DKD have not been addressed.
OBJECTIVES
To determine the efficacy and safety of low protein diets (LPD) (0.6 to 0.8 g/kg/day) in preventing the progression of CKD towards kidney failure and in reducing the incidence of kidney failure and death (any cause) in adult patients with DKD. Moreover, the effect of LPD on adverse events (e.g. malnutrition, hyperglycaemic events, or health-related quality of life (HRQoL)) and compliance were also evaluated.
SEARCH METHODS
We searched the Cochrane Kidney and Transplant Register of Studies up to 17 November 2022 through contact with the Information Specialist using search terms relevant to this review. Studies in the Register are identified through searches of CENTRAL, MEDLINE, EMBASE, conference proceedings, the International Clinical Trials Register (ICTRP) Search Portal and ClinicalTrials.gov.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) or quasi-RCTs in which adults with DKD not on dialysis were randomised to receive either a LPD (0.6 to 0.8 g/kg/day) or a usual or unrestricted protein diet (UPD) (≥ 1.0 g/kg/day) for at least 12 months.
DATA COLLECTION AND ANALYSIS
Two authors independently selected studies and extracted data. Summary estimates of effect were obtained using a random-effects model. Results were summarised as risk ratios (RR) with 95% confidence intervals (CI) for dichotomous outcomes and mean difference (MD) or standardised MD (SMD) with 95% CI for continuous outcomes. Confidence in the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.
MAIN RESULTS
We identified eight studies involving 486 participants with DKD. The prescribed protein intake in the intervention groups ranged from 0.6 to 0.8 g/kg/day. The prescribed protein intake in the control groups was ≥ 1.0 g/kg/day, or a calculated protein intake ≥ 1.0 g/kg/day if data on prescribed protein intake were not provided. The mean duration of the interventions was two years (ranging from one to five years). Risks of bias in most of the included studies were high or unclear, most notably for allocation concealment, performance and detection bias. All studies were considered to be at high risk for performance bias due to the nature of the interventions. Most studies were not designed to examine death or kidney failure. In low certainty evidence, a LPD may have little or no effect on death (5 studies, 358 participants: RR 0.38, 95% CI 0.10 to 1.44; I² = 0%), and the number of participants who reached kidney failure (4 studies, 287 participants: RR 1.16, 95% CI 0.38 to 3.59; I² = 0%). Compared to a usual or unrestricted protein intake, it remains uncertain whether a LPD slows the decline of glomerular filtration rate over time (7 studies, 367 participants: MD -0.73 mL/min/1.73 m²/year, 95% CI -2.3 to 0.83; I² = 53%; very low certainty evidence). It is also uncertain whether the restriction of dietary protein intake impacts on the annual decline in creatinine clearance (3 studies, 203 participants: MD -2.39 mL/min/year, 95% CI -5.87 to 1.08; I² = 53%). There was only one study reporting 24-hour urinary protein excretion. In very low certainty evidence, a LPD had uncertain effects on the annual change in proteinuria (1 study, 80 participants: MD 0.90 g/24 hours, 95% CI 0.49 to 1.31). There was no evidence of malnutrition in seven studies, while one study noted this condition in the LPD group. Participant compliance with a LPD was unsatisfactory in nearly half of the studies. One study reported LPD had no effect on HRQoL. No studies reported hyperglycaemic events.
AUTHORS' CONCLUSIONS
Dietary protein restriction has uncertain effects on changes in kidney function over time. However, it may make little difference to the risk of death and kidney failure. Questions remain about protein intake levels and compliance with protein-restricted diets. There are limited data on HRQoL and adverse effects such as nutritional measures and hyperglycaemic events. Large-scale pragmatic RCTs with sufficient follow-up are required for different stages of CKD.
Topics: Adult; Humans; Kidney Failure, Chronic; Diet, Protein-Restricted; Diabetic Nephropathies; Renal Insufficiency, Chronic; Malnutrition; Hyperglycemia; Diabetes Mellitus; Randomized Controlled Trials as Topic
PubMed: 36594428
DOI: 10.1002/14651858.CD014906.pub2 -
Neuro-Chirurgie Jan 2023To better understand the choice of the comparator intervention in the design of clinical trials and its impact on the meaning of results we review randomized trials on...
OBJECTIVES
To better understand the choice of the comparator intervention in the design of clinical trials and its impact on the meaning of results we review randomized trials on vertebroplasty.
METHODS
We conducted a systematic and narrative review of all randomized trials on vertebroplasty. Trials are categorized according to the comparator intervention (non-surgical management, placebo/sham vertebroplasty, and kyphoplasty).
RESULTS
All trials were too small to show a difference in objective clinical outcomes, and 20 of 23 RCTs used mean pain scores to compare interventions. Most trials comparing vertebroplasty with non-surgical management concluded that vertebroplasty was superior. Trials comparing kyphoplasty with vertebroplasty showed similar results for both interventions. However, 4 of 5 trials comparing vertebroplasty with placebo surgery failed to show a significant difference between groups.
CONCLUSION
The clinical results of an intervention cannot be interpreted without a comparison that involves a control group. The choice of comparator intervention can change the meaning of the trial. A large pragmatic trial, using hard clinical outcomes such as morbidity and mortality as a primary outcome measure, would be needed to assess the potential clinical benefits of vertebroplasty.
Topics: Humans; Osteoporotic Fractures; Fractures, Compression; Spinal Fractures; Vertebroplasty; Kyphoplasty; Treatment Outcome
PubMed: 36566694
DOI: 10.1016/j.neuchi.2022.101401 -
Reproductive Biomedicine Online Feb 2023Does flushing of the follicles at ovum retrieval increase the number of retrieved oocytes in poor-response IVF patients? (Meta-Analysis)
Meta-Analysis
RESEARCH QUESTION
Does flushing of the follicles at ovum retrieval increase the number of retrieved oocytes in poor-response IVF patients?
DESIGN
An update of an electronic literature search was performed to identify randomized controlled trials (RCT) investigating follicular flushing versus no flushing in women with a poor response to IVF treatment. No exclusion criteria for type of needle, stimulation or protocol were applied. A meta-analysis was conducted using the software RevMan 5.4.
RESULTS
Six RCT were identified that had the primary objective of testing for an increase in mean number of cumulus-oocyte complexes or/and metaphase II oocytes between flushing and no flushing. A double-lumen needle was used in five trials, one study investigated a pseudo-double-lumen needle, and a conventional single-lumen needle was used in all the control groups. The main risk of bias in all the included studies is a lack of blinding of the physicians performing the puncture and incomplete data in four trials. A heterogeneity of direction and size of effect of follicular flushing on mean oocyte number retrieved was detected (I = 80, P = 0.0001), which precludes a synthesis of the data. Two studies showed a decrease or tendency towards a decrease in oocyte numbers, one study showed similar oocyte numbers, and one study showed a strong tendency towards increased oocyte numbers with flushing. A similar picture was seen for metaphase II oocytes (I = 73, P = 0.002).
CONCLUSIONS
It is uncertain whether follicular flushing in poor-response IVF patients affects the number of retrieved oocytes. Larger pragmatic trials are warranted to clarify the effect of flushing on oocyte numbers and clinical outcomes in poor responders and monofollicular patients.
Topics: Female; Humans; Pregnancy; Embryo Transfer; Fertilization in Vitro; Oocyte Retrieval; Oocytes; Ovulation Induction; Pregnancy Rate; Randomized Controlled Trials as Topic
PubMed: 36566145
DOI: 10.1016/j.rbmo.2022.11.011 -
Implementation Science : IS Dec 2022Sustainability is concerned with the long-term delivery and subsequent benefits of evidence-based interventions. To further this field, we require a strong understanding... (Review)
Review
BACKGROUND
Sustainability is concerned with the long-term delivery and subsequent benefits of evidence-based interventions. To further this field, we require a strong understanding and thus measurement of sustainability and what impacts sustainability (i.e., sustainability determinants). This systematic review aimed to evaluate the quality and empirical application of measures of sustainability and sustainability determinants for use in clinical, public health, and community settings.
METHODS
Seven electronic databases, reference lists of relevant reviews, online repositories of implementation measures, and the grey literature were searched. Publications were included if they reported on the development, psychometric evaluation, or empirical use of a multi-item, quantitative measure of sustainability, or sustainability determinants. Eligibility was not restricted by language or date. Eligibility screening and data extraction were conducted independently by two members of the research team. Content coverage of each measure was assessed by mapping measure items to relevant constructs of sustainability and sustainability determinants. The pragmatic and psychometric properties of included measures was assessed using the Psychometric and Pragmatic Evidence Rating Scale (PAPERS). The empirical use of each measure was descriptively analyzed.
RESULTS
A total of 32,782 articles were screened from the database search, of which 37 were eligible. An additional 186 publications were identified from the grey literature search. The 223 included articles represented 28 individual measures, of which two assessed sustainability as an outcome, 25 covered sustainability determinants and one explicitly assessed both. The psychometric and pragmatic quality was variable, with PAPERS scores ranging from 14 to 35, out of a possible 56 points. The Provider Report of Sustainment Scale had the highest PAPERS score and measured sustainability as an outcome. The School-wide Universal Behaviour Sustainability Index-School Teams had the highest PAPERS score (score=29) of the measure of sustainability determinants.
CONCLUSIONS
This review can be used to guide selection of the most psychometrically robust, pragmatic, and relevant measure of sustainability and sustainability determinants. It also highlights that future research is needed to improve the psychometric and pragmatic quality of current measures in this field.
TRIAL REGISTRATION
This review was prospectively registered with Research Registry (reviewregistry1097), March 2021.
Topics: Humans; Public Health; Psychometrics
PubMed: 36514059
DOI: 10.1186/s13012-022-01252-1 -
American Journal of Perinatology May 2024Palivizumab is a humanized monoclonal antibody approved for the prevention of serious lower respiratory tract infection (LRTI) caused by respiratory syncytial virus...
OBJECTIVE
Palivizumab is a humanized monoclonal antibody approved for the prevention of serious lower respiratory tract infection (LRTI) caused by respiratory syncytial virus (RSV) in infants and young children at high risk of RSV disease. This systematic review summarized evidence on the effectiveness and safety of palivizumab when used in approved populations.
STUDY DESIGN
A systematic review of Phase III trials and observational studies was conducted according to the population, intervention, comparator, outcome, timing, setting (PICOTS) approach (PROSPERO, CRD42021281380). Target populations consisted of infants with a history of premature birth (≤35-week gestational age) and children aged <2 years with bronchopulmonary dysplasia (BPD) or with hemodynamically significant congenital heart disease (hs-CHD). Outcomes of interest included RSV-related hospitalization, admission to intensive care unit (ICU), requirement for mechanical ventilation, treatment-related adverse events (AEs), and RSV-related deaths. Information sources were literature search (Ovid MEDLINE and Embase), pragmatic searches, and snowballing (covering the period up to 07 September 2021).
RESULTS
A total of 60 sources were included (5 Phase III trials and 55 observational studies). RSV-related hospitalization rates following palivizumab prophylaxis in Phase III trials were 1.8% in premature infants and 7.9% in children with BPD, which were significantly lower than rates in placebo arms. In the real-world setting, similar hospitalization rates were found (0.7-4.0% in premature infants [16 studies] and 0-5.5% in patients with BPD [10 studies]) with ICU admission reported in 0 to 33.3% of patients hospitalized for RSV. In Phase III trials, RSV-related mortality rates were 0.2 and 0.3%, while AEs occurred in 11% of premature and/or BPD patients and 7.2% of hs-CHD patients, consisting mainly of injection site reaction, fever, and diarrhea. Similar results were found in observational studies.
CONCLUSION
This systematic review supports the effectiveness and safety of palivizumab in the indicated populations.
KEY POINTS
· Systematic review supports the positive benefit-risk profile of palivizumab in the indicated populations.. · Real-world safety and effectiveness of palivizumab are consistent with Phase III trials results.. · Palivizumab reduces RSV-related hospitalizations, ICU admissions, and need for mechanical ventilation..
Topics: Humans; Palivizumab; Respiratory Syncytial Virus Infections; Antiviral Agents; Infant; Infant, Newborn; Infant, Premature; Hospitalization; Bronchopulmonary Dysplasia; Heart Defects, Congenital; Respiration, Artificial; Respiratory Tract Infections; Observational Studies as Topic; Clinical Trials, Phase III as Topic
PubMed: 36452969
DOI: 10.1055/a-1990-2633 -
Journal of Thrombosis and Thrombolysis Feb 2023Tenecteplase (TNK) is a promising candidate to replace alteplase as the standard of care for acute ischemic stroke (AIS); however, the optimal dosage is still to be... (Meta-Analysis)
Meta-Analysis Review
The efficacy and safety of tenecteplase versus alteplase for acute ischemic stroke: an updated systematic review, pairwise, and network meta-analysis of randomized controlled trials.
Tenecteplase (TNK) is a promising candidate to replace alteplase as the standard of care for acute ischemic stroke (AIS); however, the optimal dosage is still to be investigated. Therefore, we aim to evaluate the safety and efficacy of TNK versus alteplase and to investigate the optimal TNK dosage. A systematic review, pairwise, and network meta-analysis synthesizing randomized controlled trials (RCTs) from WOS, SCOPUS, EMBASE, and PubMed until July 26, 2022. We used the risk ratio (RR) for dichotomous outcomes presented with the corresponding 95% confidence interval (CI). We registered our protocol in PROSPERO with ID: CRD42022352038. Nine RCTs with a total of 3,707 patients were included. TNK significantly led to complete recanalization (RR: 1.27 with 95% CI [1.02, 1.57], P = 0.03); however, we found no difference regarding early neurological improvement (RR: 1.07 with 95% CI [0.94, 1.21], P = 0.33) and excellent neurological recovery (RR: 1.03 with 95% CI [0.96, 1.10], P = 0.42). Also, TNK was similar to alteplase regarding mortality (RR: 0.99 with 95% CI [0.82, 1.18], P = 0.88), intracranial haemorrhage (RR: 1.00 with 95% CI [0.85, 1.18], P = 0.99), and parenchymal hematoma (RR: 1.13 with 95% CI [0.83, 1.54], P = 0.44). TNK in the dose of 0.25 mg is a viable candidate to displace alteplase as the standard of care in patients with an AIS within 4.5 h of presentation due to its better rate of early neurological recovery and non-inferiority in terms of safety outcomes. However, the evidence regarding TNK's role in AIS presenting after 4.5 h from symptoms onset, wake-up stroke, and minor stroke/TIA is still lacking, necessitating further double-blinded pragmatic RCTs in this regard.
Topics: Humans; Tissue Plasminogen Activator; Tenecteplase; Fibrinolytic Agents; Network Meta-Analysis; Randomized Controlled Trials as Topic; Stroke; Ischemic Stroke; Treatment Outcome; Brain Ischemia
PubMed: 36449231
DOI: 10.1007/s11239-022-02730-5 -
Child and Adolescent Mental Health Sep 2023School-based mental health literacy interventions aim to prevent mental disorders and promote mental wellbeing through improving the knowledge and understanding of... (Review)
Review
BACKGROUND
School-based mental health literacy interventions aim to prevent mental disorders and promote mental wellbeing through improving the knowledge and understanding of mental health, mental disorders, and reducing stigma. Evidence suggests that good mental health literacy helps young people recognise mental health difficulties in themselves and in others, and seek help for mental health problems. Improved help-seeking can allow for early intervention, which prevents the progression of mental disorders and ultimately reduces the burden of mental disorders. The aim of this review is to identify and synthesise evidence on the effectiveness of school-based mental health literacy interventions in improving help-seeking outcomes.
METHODS
We searched MEDLINE, Embase, PsycINFO, ERIC, Child Development and Adolescent Studies, British Education Index and ASSIA (June 2020). Additional searches were conducted a year later to identify any new publications (June 2021). We included randomised controlled trials (RCTs) assessing the effectiveness or cost-effectiveness of school-based interventions to improve help-seeking outcomes for children and young people aged 4-18 years. Included studies were critically appraised.
RESULTS
We identified 11 studies investigating help-seeking outcomes of school-based mental health literacy interventions including a total of 7066 participants from 66 secondary schools. Overall, there is no strong evidence for the effectiveness of school-based mental health literacy interventions in improving help-seeking outcomes, including general attitudes towards help-seeking, personal intentions to seek help, knowledge of when and how to seek help for mental disorders, confidence to seek help, and actual help-seeking behaviours. None of the studies investigated the cost-effectiveness of the interventions.
CONCLUSION
The lack of standardised measures with established reliability and validity for help-seeking outcomes, and the incomprehensive consideration of the multi-faceted concepts of MH literacy and MH stigma have contributed to the scarcity of evidence for the effectiveness. Future research should focus on developing standardised measurement tools and including economic evaluations to understand pragmatic and financial aspects of school-based mental health literacy interventions.
Topics: Child; Adolescent; Humans; Mental Health; Health Literacy; Mental Disorders; School Nursing; Schools
PubMed: 36377083
DOI: 10.1111/camh.12609