Conduct and reporting of formula milk trials: systematic review

Abstract Objective To systematically review the conduct and reporting of formula trials. Design Systematic review. Data sources Medline, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched from 1 January 2006 to 31 December 2020. Review methods Intervention trials comparing at least two formula products in children less than three years of age were included, but not trials of human breast milk or fortifiers of breast milk. Data were extracted in duplicate and primary outcome data were synthesised for meta-analysis with a random effects model weighted by the inverse variance method. Risk of bias was evaluated with Cochrane risk of bias version 2.0, and risk of undermining breastfeeding was evaluated according to published consensus guidance. Primary outcomes of the trials included in the systematic review were identified from clinical trial registries, protocols, or trial publications. Results 22 201 titles were screened and 307 trials were identified that were published between 2006 and 2020, of which 73 (24%) trials in 13 197 children were prospectively registered. Another 111 unpublished but registered trials in 17 411 children were identified. Detailed analysis was undertaken for 125 trials (23 757 children) published since 2015. Seventeen (14%) of these recently published trials were conducted independently of formula companies, 26 (21%) were prospectively registered with a clear aim and primary outcome, and authors or sponsors shared prospective protocols for 11 (9%) trials. Risk of bias was low in five (4%) and high in 100 (80%) recently published trials, mainly because of inappropriate exclusions from analysis and selective reporting. For 68 recently published superiority trials, a pooled standardised mean difference of 0.51 (range −0.43 to 3.29) was calculated with an asymmetrical funnel plot (Egger’s test P<0.001), which reduced to 0.19 after correction for asymmetry. Primary outcomes were reported by authors as favourable in 86 (69%) trials, and 115 (92%) abstract conclusions were favourable. One of 38 (3%) trials in partially breastfed infants reported adequate support for breastfeeding and 14 of 87 (16%) trials in non-breastfed infants confirmed the decision not to breastfeed was firmly established before enrolment in the trial. Conclusions The results show that formula trials lack independence or transparency, and published outcomes are biased by selective reporting. Systematic review registration PROSPERO 2018 CRD42018091928.

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The Effect of β-Blockers for Burn Patients on Clinical Outcomes: Systematic Review and Meta-Analysis

Journal of Intensive Care Medicine ◽

10.1177/0885066620940188 ◽

2020 ◽

pp. 088506662094018

Author(s):

Nasreen Hassoun-Kheir ◽

Oryan Henig ◽

Tomer Avni ◽

Leonard Leibovici ◽

Mical Paul

Keyword(s):

Systematic Review ◽

Primary Outcome ◽

Meta Analysis ◽

Risk Of Bias ◽

Hospitalized Patients ◽

Sufficient Evidence ◽

Selective Reporting ◽

Significant Difference ◽

Β Blocker ◽

Β Blockers

Objectives: To assess the effects and safety of β-blockers in hospitalized patients with burns. Methods: A systematic review and meta-analysis of the literature. A broad search was conducted to identify all randomized controlled trials (RCTs) comparing β-blockers to control in hospitalized patients with burns. The primary outcome was 3-month all-cause mortality. Secondary outcomes were clinical patient-relevant end points. We subgrouped results by children/adults and burn severity. Risk of bias was assessed using the individual domain approach. Results: Four RCTs reported in 11 publications were included. Primary outcome of mortality was assessed in children (2 trials, n = 424) and adults (2 trials, n = 148) with severe burns. No significant difference was found between propranolol and control for mortality (risk ratio [RR] = 0.82, 95% CI = 0.48-1.39, 4 trials with broad confidence intervals in adults and children), sepsis (RR = 0.81, 95% CI = 0.46-1.43, 2 trials), and survivors’ length of stay (absolute mean difference = 2.53, 95% CI = −2.58–7.63, 3 trials). There was no significant difference in bradycardia (RR = 1.33, 95% CI = 0.77-2.3, 2 trials), hypotension (RR = 1.26, 95% CI = 0.73-2.17, 3 trials), or cardiac arrhythmia (RR: 2.97, 95% CI: 0.12-71.87, 1 trial). The evidence was graded as very low certainty, due to trial’s internal risk of bias, imprecision, and possible selective reporting. Conclusions: No sufficient evidence was found to support or refute an advantage for β-blocker use in children or adults after burns. Additional studies are needed to create a consensus and formulate practice guidelines on the optimal β-blocker to use, indications for initiation, and duration of treatment.

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Surgical Interventions for the Treatment of Supracondylar Humerus Fractures in Children: Protocol of a Systematic Review (Preprint)

10.2196/preprints.8343 ◽

2017 ◽

Author(s):

Oreste Lemos Carrazzone ◽

João Carlos Belloti ◽

Fabio Teruo Matsunaga ◽

Nacime Salomão Barbachan Mansur ◽

Marcelo Hide Matsumoto ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Surgical Treatment ◽

Randomized Controlled Trials ◽

Outcome Data ◽

Risk Of Bias ◽

Controlled Trials ◽

Cochrane Central Register ◽

Surgical Interventions ◽

Randomized Controlled

BACKGROUND The treatment of supracondylar humerus fracture in children (SHFC) is associated with complications such as functional deficit, residual deformity, and iatrogenic neurological damage. The standard treatment is closed reduction and percutaneous Kirschner wire fixation with different configurations. Despite this fact, there is still no consensus on the most effective technique for the treatment of these fractures. OBJECTIVE The aim of this systematic review will be to evaluate the effect of surgical interventions on the treatment of Gartland type II and III SHFC by assessing function, complications, and error as primary outcomes. Clinical outcomes such as range of motion and pain and radiographic outcomes will also be judged. METHODS A systematic review of randomized controlled trials or quasi-randomized controlled trials evaluating the surgical treatment of SHFC will be carried out in the Cochrane Central Register of Controlled Trials, PubMed, Literatura Latino-Americana e do Caribe em Ciências da Saúde, and Excerpta Medica Database. The search will also occur at ongoing and recently completed clinical trials in selected databases. Data management and extraction will be performed using a data withdrawal form and by analyzing the following: study method characteristics, participant characteristics, intervention characteristics, results, methodological domains, and risk of bias. To assess the risk of bias of the included trials, the Cochrane Risk of Bias Tool will be used. Dichotomous outcome data will be analyzed as risk ratios, and continuous outcome data will be expressed as mean differences, both with 95% confidence intervals. Also, whenever possible, subgroup analysis, sensitivity analysis, and assessment of heterogeneity will be performed. RESULTS Following the publication of this protocol, searches will be run and included studies will be deeply analyzed. We hope to obtain final results in the next few months and have the final paper published by the end of 2018. This study was funded by a government-based noncommercial agency, Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP). CONCLUSIONS This study may provide surgical treatment effects evidence for SHFC. The results will assist clinical practice by demonstrating the effectiveness and potential complications of these interventions and might serve as a reference for future clinical trials on the topic. CLINICALTRIAL PROSPERO CRD42014009304; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=9304 (Archived by WebCite at http://www.webcitation.org/6usiDHzD7)

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Across The “Sweetiest” Properties Of Human Breast Milk: Focus On Oligosaccharides

Current Pediatric Reviews ◽

10.2174/1573396316666200429114217 ◽

2020 ◽

Vol 16 ◽

Cited By ~ 1

Author(s):

Flaminia Bardanzellu ◽

Alessandra Reali ◽

Maria Antonietta Marcialis ◽

Vassilios Fanos

Keyword(s):

Breast Milk ◽

Active Role ◽

Individual Variability ◽

Human Breast Milk ◽

Formula Milk ◽

Target Organs ◽

Lactating Mothers ◽

Neonatal Nutrition ◽

Genetic And Environmental Factors ◽

Systemic Infections

Introduction: Breast Milk (BM), containing nutrients and bioactive components, represents the best source for neonatal nutrition and determines short- and long- term benefits. Human milk oligosaccharides (HMOs) play an active role in these pathophysiological mechanisms. In fact; they influence the shaping of breastfed infant’s gut microbiota, promote intestinal development, confer protection against intestinal or systemic infections modulating immune system; moreover, HMOs determine extra-intestinal effects on several target organs, i.e reducing necrotizing enterocolitis rate or improving brain development. Aims: In this review, we analyze the great inter- and intra-individual variability of BM HMOs, investigating maternal, genetic and environmental factors modulating their composition. Moreover, we provide an update regarding HMOs’ unique properties, underlining their complex interaction with intestinal microbiota and host-derived metabolites. The possible HMOs’ influence on extra-intestinal bacterial communities, potentially influencing newborns’ and even lactating mothers’ health, have been hypothesized. Finally, recognized HMOs’ crucial role, we underline the promising opportunities showed by their addition in formula milk, useful to create dairy products more similar to maternal milk itself.

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Risk of colectomy after conservative treatment of diverticulitis of the left hemicolon complicated by abdominal or pelvic abscess: protocol of a systematic review and meta-analysis

BMJ Open ◽

10.1136/bmjopen-2020-042350 ◽

2020 ◽

Vol 10 (12) ◽

pp. e042350

Author(s):

Maximilian Sohn ◽

Ayman Agha ◽

Igors Iesalnieks ◽

Anna Tiefes ◽

Alfred Hochrein ◽

...

Keyword(s):

Systematic Review ◽

Emergency Surgery ◽

Case Reports ◽

Acute Diverticulitis ◽

Meta Analysis ◽

Case Series ◽

Pelvic Abscess ◽

Risk Of Bias ◽

Cochrane Central Register ◽

Review Manager

IntroductionAcute diverticulitis of the sigmoid colon is increasingly treated by a non-operative approach. The need for colectomy after recovery from a flare of acute diverticulitis of the left colon, complicated diverticular abscess is still controversial. The primary aim of this study is to assess the risk of interval emergency surgery by systematic review and meta-analysis.Methods and analysisThe systematic review and meta-analysis will be conducted in accordance to the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols statement. PubMed/MEDLINE, Cochrane Central Register of Controlled Trials and EMBASE will be screened for the predefined searching term: (Diverticulitis OR Diverticulum) AND (Abscess OR pelvic abscess OR pericolic abscess OR intraabdominal abscess) AND (surgery OR operation OR sigmoidectomy OR drainage OR percutaneous drainage OR conservative therapy OR watchful waiting). All studies published in an English or German-speaking peer-reviewed journal will be suitable for this analysis. Case reports, case series of less than five patients, studies without follow-up information, systematic and non-systematic reviews and meta-analyses will be excluded. Primary endpoint is the rate of interval emergency surgery. Using the Review Manager Software (Review Manager/RevMan, V.5.3, Copenhagen, The Nordic Cochrane Centre, The Cochrane Collaboration, 2012) meta-analysis will be pooled using the Mantel-Haenszel method for random effects. The Risk of Bias in Non-randomized Studies of Interventions tool will be used to assess methodological quality of non-randomised studies. Risk of bias in randomised studies will be assessed using the Cochrane developed RoB 2-tool.Ethics and disseminationAs no new data are being collected, ethical approval is exempt for this study. This systematic review is to provide a new insight on the need for surgical treatment after a first attack of acute diverticulitis, complicated by intra-abdominal or pelvic abscesses. The results of this study will be presented at national and international meetings and published in a peer-reviewed journal.PROSPERO registration numberCRD42020164813.

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Effect of consumption of animal milk compared to infant formula for non-breastfed/mixed-fed infants 6–11 months of age: a systematic review (protocol)

BMJ Open ◽

10.1136/bmjopen-2020-046370 ◽

2021 ◽

Vol 11 (2) ◽

pp. e046370

Author(s):

Aamer Imdad ◽

Julie Melissa Ehrlich ◽

Joseph Catania ◽

Emily Tanner-Smith ◽

Abigail Smith ◽

...

Keyword(s):

Systematic Review ◽

Infant Formula ◽

Breast Feeding ◽

Meta Analysis ◽

Risk Of Bias ◽

World Health ◽

Control Group ◽

Breastfed Infants ◽

Evaluation Approach ◽

Animal Milk

IntroductionPrevalence rates of breastfeeding remain low even though the World Health Organization (WHO) and the American Academy of Pediatrics recommend exclusive breast feeding for the first 6 months of life in combination with appropriate complementary feeding beyond six 6 months of age. There have been several studies that address the implication of drinking animal milk and/or infant formula on children’s health and development when breast feeding is not offered during the first year of life. Vast improvements have been made in infant formula design, which may increase its benefits compared with animal’s milk. The objective of this review is therefore to synthesise the most recent evidence on the effects of the consumption of animal milk compared with infant formula in non-breastfed or mixed breastfed infants aged 6–11 months.Methods and analysisWe will conduct a systematic review and meta-analysis of studies that assessed the effect of animal milk compared with formula or mixed-fed (breastmilk and formula) on infants aged 6–11 months. The primary outcomes of interest include anaemia, gastrointestinal blood loss, weight for age, height for age and weight for height. We will include randomised and non-randomised studies with a control group. We will use the Cochrane risk of bias tools to assess the risk of bias. We will use meta-analysis to pool findings if the identified studies are conceptually homogenous and data are available from more than one study. We will assess the overall quality of evidence using the Grading of Recommendations Assessment, Development, and Evaluation approach.Ethics and disseminationThis is a systematic review, so no patients will be directly involved in the design or development of this study. The findings from this systematic review will be disseminated to relevant patient populations and caregivers and will guide the WHO’s recommendations on formula consumption versus animal milk in infants aged 6–11 months.Trial registration numberCRD42020210925.

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Impact of COVID-19 pandemic on utilisation of healthcare services: a systematic review

BMJ Open ◽

10.1136/bmjopen-2020-045343 ◽

2021 ◽

Vol 11 (3) ◽

pp. e045343

Author(s):

Ray Moynihan ◽

Sharon Sanders ◽

Zoe A Michaleff ◽

Anna Mae Scott ◽

Justin Clark ◽

...

Keyword(s):

Systematic Review ◽

Primary Outcome ◽

Unmet Need ◽

Healthcare Utilisation ◽

Healthcare Services ◽

Risk Of Bias ◽

Secondary Outcome ◽

Severe Illness ◽

Service Utilisation ◽

Registration Number

ObjectivesTo determine the extent and nature of changes in utilisation of healthcare services during COVID-19 pandemic.DesignSystematic review.EligibilityEligible studies compared utilisation of services during COVID-19 pandemic to at least one comparable period in prior years. Services included visits, admissions, diagnostics and therapeutics. Studies were excluded if from single centres or studied only patients with COVID-19.Data sourcesPubMed, Embase, Cochrane COVID-19 Study Register and preprints were searched, without language restrictions, until 10 August, using detailed searches with key concepts including COVID-19, health services and impact.Data analysisRisk of bias was assessed by adapting the Risk of Bias in Non-randomised Studies of Interventions tool, and a Cochrane Effective Practice and Organization of Care tool. Results were analysed using descriptive statistics, graphical figures and narrative synthesis.Outcome measuresPrimary outcome was change in service utilisation between prepandemic and pandemic periods. Secondary outcome was the change in proportions of users of healthcare services with milder or more severe illness (eg, triage scores).Results3097 unique references were identified, and 81 studies across 20 countries included, reporting on >11 million services prepandemic and 6.9 million during pandemic. For the primary outcome, there were 143 estimates of changes, with a median 37% reduction in services overall (IQR −51% to −20%), comprising median reductions for visits of 42% (−53% to −32%), admissions 28% (−40% to −17%), diagnostics 31% (−53% to −24%) and for therapeutics 30% (−57% to −19%). Among 35 studies reporting secondary outcomes, there were 60 estimates, with 27 (45%) reporting larger reductions in utilisation among people with a milder spectrum of illness, and 33 (55%) reporting no difference.ConclusionsHealthcare utilisation decreased by about a third during the pandemic, with considerable variation, and with greater reductions among people with less severe illness. While addressing unmet need remains a priority, studies of health impacts of reductions may help health systems reduce unnecessary care in the postpandemic recovery.PROSPERO registration numberCRD42020203729.

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Levels of Trace Elements in Human Breast Milk in Jordan: a Comparison with Infant Formula Milk Powder

Biological Trace Element Research ◽

10.1007/s12011-020-02547-4 ◽

2021 ◽

Author(s):

Yahya R. Tahboub ◽

Adnan M. Massadeh ◽

Nihaya A. Al-sheyab ◽

Diab El shrafat ◽

Israa A. Nsserat

Keyword(s):

Trace Elements ◽

Breast Milk ◽

Infant Formula ◽

Milk Powder ◽

Human Breast Milk ◽

Human Breast ◽

Formula Milk ◽

Infant Formula Milk

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Comparison of effects of different dietary interventions on cognitive function in Alzheimer’s disease: protocol for systematic review and network meta-analysis

BMJ Open ◽

10.1136/bmjopen-2020-042997 ◽

2021 ◽

Vol 11 (1) ◽

pp. e042997

Author(s):

Lili Chen ◽

Xinhua Xu ◽

Huizhen Cao ◽

Hong Li

Keyword(s):

Systematic Review ◽

Alzheimer’S Disease ◽

Alzheimer's Disease ◽

Cognitive Function ◽

Risk Of Bias ◽

Evaluation Framework ◽

Controlled Trials ◽

Cochrane Central Register ◽

Dietary Interventions ◽

Meta Analyses

IntroductionAlzheimer’s disease (AD) is the most common neurodegenerative disease and is characterised by cognitive impairment. Non-pharmacological treatments such as diet therapy have been widely investigated in studies on AD. Given the synergistic effects of nutrients present in foods, considering overall dietary composition rather than focusing on a single nutrient may be more useful for evaluating the relationship between diet and AD cognition. The present study aimed to assess the efficacy of different dietary interventions (eg, ketogenic and Mediterranean diets) on cognitive function in patients with AD in a systematic review and pairwise and network meta-analyses of randomised controlled trials or clinical trials.Methods and analysisTwo reviewers will independently conduct searches of PubMed, Cochrane Central Register of Controlled Trials, Embase, CINAHL, PsycINFO and China National Knowledge Infrastructure databases. Data will be extracted from selected studies and risk of bias will be assessed using the revised Cochrane risk-of-bias tool, and evidence quality will be assessed according to the Grading of Recommendations, Assessment, Development and Evaluation framework. The primary outcome of interest is cognitive function in patients with AD; secondary outcomes include biochemical biomarkers of AD and oxidative stress and/or inﬂammatory biomarkers in cerebrospinal fluid or plasma. For each outcome, random-effects pairwise and network meta-analyses will be carried out to determine the pooled relative effect of each intervention relative to every other intervention.Ethics and disseminationAs this study is based solely on published literature, no ethics approval is required. The research will be published in a peer-reviewed journal.

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Abstract 20: The Effect of Resistance Training on Survival and Cardiovascular Outcomes: A Systematic Review and Meta-Analysis

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/circoutcomes.11.suppl_1.20 ◽

2018 ◽

Vol 11 (suppl_1) ◽

Author(s):

Farzane Saeidifard ◽

Jose R Medina Inojosa ◽

Colin P West ◽

Thomas P Olson ◽

Virend K Somers ◽

...

Keyword(s):

Systematic Review ◽

Heart Disease ◽

Resistance Training ◽

Subgroup Analysis ◽

Cancer Mortality ◽

Meta Analysis ◽

Cardiovascular Outcomes ◽

Risk Of Bias ◽

Cochrane Central Register ◽

All Cause Mortality

Background: This is the first systematic review and meta-analysis to investigate the effect of resistance training (RT) on survival and other cardiovascular outcomes including ischemic heart disease events and stroke. Methods: An experienced librarian searched databases up to September 25 th , 2017, for randomized trials and cohort studies that evaluated the effect of RT on survival and cardiovascular events in the general population. The databases included Ovid MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus. Two investigators conducted the screening process independently and in duplicate. Cochrane tools were used to assess the risk of bias in clinical trials and observational studies. We calculated hazard ratios and 95% confidence intervals using RevMan and fixed and random effect models and had a subgroup analysis based on doses of RT and for the combination of RT and aerobic exercise (AE) vs no exercise. Results: The search identified 1429 studies from which 10 (one randomized trial) met the inclusion criteria, including 338,254 participants with a mean follow up of 8.14 years. The meta-analysis showed that RT, in comparison with no exercises, is associated with 24% lower all-cause mortality and 48% lower mortality when combined with AE. Based on subgroup analysis, performing 1-2 sessions of RT/week is associated with lower all-cause mortality by 28% (HR 0.72, 95% CI 0.66-0.78) whereas > 5 sessions of RT/week has no association with all-cause mortality (HR 0.99, 95% CI 0.76-1.31). Further, RT alone or combined with AE is associated with lower CV mortality compared to no exercise (Figures). Finally, RT alone also showed a borderline association with lower all-cancer mortality. Heterogeneity was present for several comparisons, and subsequent analysis will explore sources of this variability. Using study design-specific Cochrane risk of bias tools, no major sources of bias were identified in the included studies. One cohort study looked at the effect of RT on coronary heart disease events and found 23% risk reduction in men, while no study specifically assessed the effect of RT on cerebrovascular outcomes. Conclusion: RT is associated with lower all-cause, CV and all-cancer mortality. RT appears to have an additive effect when combined with AE.

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Effectiveness of orthodontic temporary anchorage devices in canine retraction and anchorage preservation during the two-step technique: a systematic review and meta-analysis

BMC Oral Health ◽

10.1186/s12903-020-01271-8 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Haonan Tian ◽

Congman Xie ◽

Min Lin ◽

Hongmei Yang ◽

Aishu Ren

Keyword(s):

Systematic Review ◽

Meta Analysis ◽

Risk Of Bias ◽

Controlled Trials ◽

Cochrane Central Register ◽

Canine Retraction ◽

Temporary Anchorage Devices ◽

The Mean ◽

Mean Differences ◽

Implant Anchorage

Abstract Background Temporary anchorage devices have been used for decades in orthodontic practice for many applications. The aim of this systematic review was to assess the effectiveness of orthodontic temporary anchorage devices in canine retraction during the two-step technique. Methods A search was systematically performed for articles published prior to June 30, 2019 in five electronic databases (PubMed, Embase, Cochrane Central Register of Controlled Trials, Web of Science, Scopus). The risk of bias was assessed using the Cochrane risk of bias tool for randomized controlled trials (RCTs) and the risk of bias in nonrandomized studies of interventions (ROBINS-I) tool for controlled clinical trials (CCTs). The Grading of Recommendation, Assessment, Development and Evaluation (GRADE) approach was used for the quality assessment. Data concerning the mean difference in mesial molar movement and extent of canine retraction were extracted for statistical analysis. The mean differences and 95% confidence intervals were analyzed for continuous data. A meta-analysis with a random-effects model for comparable outcomes was carried out. Results Three RCTs and five CCTs were finally included. Meta-analysis showed a significant increase not only in anchorage preservation in the implant anchorage group in both the maxilla (1.56 mm, 95% CI: 1.14 to 1.98, P < 0.00001) and the mandible (1.62 mm, 95% CI: 1.24 to 2.01, P < 0.00001) but also in canine retraction in the implant anchorage group in both the maxilla (0.43 mm, 95% CI: 0.16 to 0.69, P = 0.001) and the mandible (0.26 mm, 95% CI: 0.02 to 0.49, P = 0.03). Conclusions There is very low-quality evidence showing that implant anchorage is more efficient than conventional anchorage during canine retraction. Additional high-quality studies are needed.

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