-
PloS One 2023To systematically evaluate the empirical evidence on the impact of community-based health insurance (CBHI) on healthcare utilization and financial risk protection in... (Meta-Analysis)
Meta-Analysis
BACKGROUND
To systematically evaluate the empirical evidence on the impact of community-based health insurance (CBHI) on healthcare utilization and financial risk protection in low- and middle-income countries (LMIC).
METHODS
We searched PubMed, CINAHL, Cochrane CENTRAL, CNKI, PsycINFO, Scopus, WHO Global Index Medicus, and Web of Science including grey literature, Google Scholar®, and citation tracking for randomized controlled trials (RCTs), non-RCTs, and quasi-experimental studies that evaluated the impact of CBHI schemes on healthcare utilization and financial risk protection in LMICs. We assessed the risk of bias using Cochrane's Risk of Bias 2.0 and Risk of Bias in Non-randomized Studies of Interventions tools for RCTs and quasi/non-RCTs, respectively. We also performed a narrative synthesis of all included studies and meta-analyses of comparable studies using random-effects models. We pre-registered our study protocol on PROSPERO: CRD42022362796.
RESULTS
We identified 61 articles: 49 peer-reviewed publications, 10 working papers, 1 preprint, and 1 graduate dissertation covering a total of 221,568 households (1,012,542 persons) across 20 LMICs. Overall, CBHI schemes in LMICs substantially improved healthcare utilization, especially outpatient services, and improved financial risk protection in 24 out of 43 studies. Pooled estimates showed that insured households had higher odds of healthcare utilization (AOR = 1.60, 95% CI: 1.04-2.47), use of outpatient health services (AOR = 1.58, 95% CI: 1.22-2.05), and health facility delivery (AOR = 2.21, 95% CI: 1.61-3.02), but insignificant increase in inpatient hospitalization (AOR = 1.53, 95% CI: 0.74-3.14). The insured households had lower out-of-pocket health expenditure (AOR = 0.94, 95% CI: 0.92-0.97), lower incidence of catastrophic health expenditure at 10% total household expenditure (AOR = 0.69, 95% CI: 0.54-0.88), and 40% non-food expenditure (AOR = 0.72, 95% CI: 0.54-0.96). The main limitations of our study are the limited data available for meta-analyses and high heterogeneity persisted in subgroup and sensitivity analyses.
CONCLUSIONS
Our study shows that CBHI generally improves healthcare utilization but inconsistently delivers financial protection from health expenditure shocks. With pragmatic context-specific policies and operational modifications, CBHI could be a promising mechanism for achieving universal health coverage (UHC) in LMICs.
Topics: Humans; Developing Countries; Community-Based Health Insurance; Delivery of Health Care; Health Expenditures; Universal Health Insurance; Insurance, Health
PubMed: 37368882
DOI: 10.1371/journal.pone.0287600 -
Journal of Global Health 2021Reducing preterm birth and stillbirth and improving outcomes for babies born too soon is essential to reduce under-5 mortality globally. In the context of a rapidly...
BACKGROUND
Reducing preterm birth and stillbirth and improving outcomes for babies born too soon is essential to reduce under-5 mortality globally. In the context of a rapidly evolving evidence base and problems with extrapolating efficacy data from high- to low-income settings, an assessment of the evidence for maternal and newborn interventions specific to low- and middle-income countries (LMICs) is required.
METHODS
A systematic review of the literature was done. We included all studies performed in LMICs since the Every Newborn Action Plan, between 2013 - 2018, which reported on interventions where the outcome assessed was reduction in preterm birth or stillbirth incidence and/or a reduction in preterm infant neonatal mortality. Evidence was categorised according to maternal or neonatal intervention groups and a narrative synthesis conducted.
RESULTS
179 studies (147 primary evidence studies and 32 systematic reviews) were identified in 82 LMICs. 81 studies reported on maternal interventions and 98 reported on neonatal interventions. Interventions in pregnant mothers which resulted in significant reductions in preterm birth and stillbirth were (i) multiple micronutrient supplementation and (ii) enhanced quality of antenatal care. Routine antenatal ultrasound in LMICs increased identification of fetal antenatal conditions but did not reduce stillbirth or preterm birth due to the absence of services to manage these diagnoses. Interventions in pre-term neonates which improved their survival included (i) feeding support including probiotics and (ii) thermal regulation. Improved provision of neonatal resuscitation did not improve pre-term mortality rates, highlighting the importance of post-resuscitation care. Community mobilisation, for example through community education packages, was found to be an effective way of delivering interventions.
CONCLUSIONS
Evidence supports the implementation of several low-cost interventions with the potential to deliver reductions in preterm birth and stillbirth and improve outcomes for preterm babies in LMICs. These, however, must be complemented by overall health systems strengthening to be effective. Quality improvement methodology and learning health systems approaches can provide important means of understanding and tackling implementation challenges within local contexts. Further pragmatic efficacy trials of interventions in LMICs are essential, particularly for interventions not previously tested in these contexts.
Topics: Developing Countries; Female; Humans; Infant; Infant, Newborn; Infant, Premature; Pregnancy; Premature Birth; Resuscitation; Stillbirth
PubMed: 35003711
DOI: 10.7189/jogh.11.04050 -
BMC Health Services Research Feb 2021Implementation of Professional Pharmacy Services (PPSs) requires a demonstration of the service's impact (efficacy) and its effectiveness. Several systematic reviews and...
BACKGROUND
Implementation of Professional Pharmacy Services (PPSs) requires a demonstration of the service's impact (efficacy) and its effectiveness. Several systematic reviews and randomised controlled trials (RCT) have shown the efficacy of PPSs in patient's outcomes in community pharmacy. There is, however, a need to determine the level of evidence on the effectiveness of PPSs in daily practice by means of pragmatic trials. To identify and analyse pragmatic RCTs that measure the effectiveness of PPSs in clinical, economic and humanistic outcomes in the community pharmacy setting.
METHODS
A systematic search was undertaken in MEDLINE, EMBASE, the Cochrane Library and SCIELO. The search was performed on January 31, 2020. Papers were assessed against the following inclusion criteria (1) The intervention could be defined as a PPS; (2) Undertaken in a community pharmacy setting; (3) Was an original paper; (4) Reported quantitative measures of at least one health outcome indicator (ECHO model); (5) The design was considered as a pragmatic RCT, that is, it fulfilled 3 predefined attributes. External validity was analyzed with PRECIS- 2 tool.
RESULTS
The search strategy retrieved 1,587 papers. A total of 12 pragmatic RCTs assessing 5 different types of PPSs were included. Nine out of the 12 papers showed positive statistically significant differences in one or more of the primary outcomes (clinical, economic or humanistic) that could be associated with the following PPS: Smoking cessation, Dispensing/Adherence service, Independent prescribing and MTM. No paper reported on cost-effectiveness outcomes.
CONCLUSIONS
There is limited available evidence on the effectiveness of community-based PPS. Pragmatic RCTs to evaluate clinical, humanistic and economic outcomes of PPS are needed.
Topics: Community Pharmacy Services; Cost-Benefit Analysis; Delivery of Health Care; Humans; Pharmaceutical Services; Pharmacies
PubMed: 33596906
DOI: 10.1186/s12913-021-06150-8 -
PLoS Medicine Mar 2022Global HIV treatment programs have sought to lengthen the interval between clinical encounters for people living with HIV (PLWH) who are established on antiretroviral... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Global HIV treatment programs have sought to lengthen the interval between clinical encounters for people living with HIV (PLWH) who are established on antiretroviral treatment (ART) to reduce the burden of seeking care and to decongest health facilities. The overall effect of reduced visit frequency on HIV treatment outcomes is however unknown. We conducted a systematic review and meta-analysis to evaluate the effect of implementation strategies that reduce the frequency of clinical appointments and ART refills for PLWH established on ART.
METHODS AND FINDINGS
We searched databases between 1 January 2010 and 9 November 2021 to identify randomized controlled trials (RCTs) and observational studies that compared reduced (6- to 12-monthly) clinical consultation or ART refill appointment frequency to 3- to 6-monthly appointments for patients established on ART. We assessed methodological quality and real-world relevance, and used Mantel-Haenszel methods to generate pooled risk ratios (RRs) with 95% confidence intervals for retention, viral suppression, and mortality. We evaluated heterogeneity quantitatively and qualitatively, and overall evidence certainty using GRADE. Searches yielded 3,955 records, resulting in 10 studies (6 RCTs, 3 observational studies, and 1 study contributing observational and RCT data) representing 15 intervention arms with 33,599 adults (≥16 years) in 8 sub-Saharan African countries. Reduced frequency clinical consultations occurred at health facilities, while reduced frequency ART refills were delivered through facility or community pharmacies and adherence groups. Studies were highly pragmatic, except for some study settings and resources used in RCTs. Among studies comparing reduced clinical consultation frequency (6- or 12-monthly) to 3-monthly consultations, there appeared to be no difference in retention (RR 1.01, 95% CI 0.97-1.04, p = 0.682, 8 studies, low certainty), and this finding was consistent across 6- and 12-monthly consultation intervals and delivery strategies. Viral suppression effect estimates were markedly influenced by under-ascertainment of viral load outcomes in intervention arms, resulting in inconclusive evidence. There was similarly insufficient evidence to draw conclusions on mortality (RR 1.12, 95% CI 0.75-1.66, p = 0.592, 6 studies, very low certainty). For ART refill frequency, there appeared to be little to no difference in retention (RR 1.01, 95% CI 0.98-1.06, p = 0.473, 4 RCTs, moderate certainty) or mortality (RR 1.45, 95% CI 0.63-3.35, p = 0.382, 4 RCTs, low certainty) between 6-monthly and 3-monthly visits. Similar to the analysis for clinical consultations, although viral suppression appeared to be better in 3-monthly arms, effect estimates were markedly influence by under-ascertainment of viral load outcomes in intervention arms, resulting in overall inclusive evidence. This systematic review was limited by the small number of studies available to compare 12- versus 6-monthly clinical consultations, insufficient data to compare implementation strategies, and lack of evidence for children, key populations, and low- and middle-income countries outside of sub-Saharan Africa.
CONCLUSIONS
Based on this synthesis, extending clinical consultation intervals to 6 or 12 months and ART dispensing intervals to 6 months appears to result in similar retention to 3-month intervals, with less robust conclusions for viral suppression and mortality. Future research should ensure complete viral load outcome ascertainment, as well as explore mechanisms of effect, outcomes in other populations, and optimum delivery and monitoring strategies to ensure widespread applicability of reduced frequency visits across settings.
Topics: Adult; Anti-Retroviral Agents; Child; HIV Infections; Humans; Time Factors; Treatment Outcome; Viral Load
PubMed: 35316272
DOI: 10.1371/journal.pmed.1003959 -
BMJ Open Jul 2020To synthesise findings from randomised controlled trials (RCTs) of interventions aimed at increasing medication adherence in individuals with type 2 diabetes (T2DM)... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
To synthesise findings from randomised controlled trials (RCTs) of interventions aimed at increasing medication adherence in individuals with type 2 diabetes (T2DM) and/or cardiovascular disease (CVD). And, in a novel approach, to compare the intervention effect of studies which were categorised as being more pragmatic or more explanatory using the Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) tool, to identify whether study design affects outcomes. As explanatory trials are typically held under controlled conditions, findings from such trials may not be relatable to real-world clinical practice. In comparison, pragmatic trials are designed to replicate real-world conditions and therefore findings are more likely to represent those found if the intervention were to be implemented in routine care.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES
Ovid Medline, Ovid Embase, Web of Science and CINAHL from 1 January 2013 to 31 December 2018.
ELIGIBILITY CRITERIA FOR SELECTING STUDIES
RCTs lasting ≥3 months (90 days), involving ≥200 patients in the analysis, with either established CVD and/or T2DM and which measured medication adherence. From 4403 citations, 103 proceeded to full text review. Studies published in any language other than English and conference abstracts were excluded.
MAIN OUTCOME MEASURE
Change in medication adherence.
RESULTS
Of 4403 records identified, 34 studies were considered eligible, of which 28, including 30 861 participants, contained comparable outcome data for inclusion in the meta-analysis. Overall interventions were associated with an increase in medication adherence (OR 1.57 (95% CI: 1.33 to 1.84), p<0.001; standardised mean difference 0.24 (95% CI: -0.10 to 0.59) p=0.101). The effectiveness of interventions did not differ significantly between studies considered pragmatic versus explanatory (p=0.598), but did differ by intervention type, with studies that included a multifaceted rather than a single-faceted intervention having a more significant effect (p=0.010). The analysis used random effect models and used the revised Cochrane Risk of Bias Tool to assess study quality.
CONCLUSIONS
In this meta-analysis, interventions were associated with a significant increase in medication adherence. Overall multifaceted interventions which included an element of education alongside regular patient contact or follow-up showed the most promise. Effectiveness of interventions between pragmatic and explanatory trials was comparable, suggesting that findings can be transferred from idealised to real-word conditions.
PROSPERO REGISTRATION NUMBER
CRD42017059460.
Topics: Cardiovascular Diseases; Humans; Medication Adherence
PubMed: 32709649
DOI: 10.1136/bmjopen-2019-036575 -
JMIR Mental Health Nov 2022Informal caregivers commonly experience mental health difficulties related to their caregiving role. e-Mental health interventions provide mental health support in a... (Review)
Review
Implementation of e-Mental Health Interventions for Informal Caregivers of Adults With Chronic Diseases: Mixed Methods Systematic Review With a Qualitative Comparative Analysis and Thematic Synthesis.
BACKGROUND
Informal caregivers commonly experience mental health difficulties related to their caregiving role. e-Mental health interventions provide mental health support in a format that may be more accessible to informal caregivers. However, e-mental health interventions are seldom implemented in real-world practice.
OBJECTIVE
This mixed methods systematic review aimed to examine factors associated with the effectiveness and implementation of e-mental health interventions for informal caregivers of adults with chronic diseases. To achieve this aim, two approaches were adopted: combinations of implementation and intervention characteristics sufficient for intervention effectiveness were explored using qualitative comparative analysis, and barriers to and facilitators of implementation of e-mental health interventions for informal caregivers were explored using thematic synthesis.
METHODS
We identified relevant studies published from January 1, 2007, to July 6, 2022, by systematically searching 6 electronic databases and various secondary search strategies. Included studies reported on the effectiveness or implementation of e-mental health interventions for informal caregivers of adults with cancer, chronic obstructive pulmonary disease, dementia, diabetes, heart disease, or stroke. Randomized controlled trials reporting on caregivers' mental health outcomes were included in a crisp-set qualitative comparative analysis. We assessed randomized controlled trials for bias using the Risk of Bias 2.0 tool, and we assessed how pragmatic or explanatory their trial design was using the Pragmatic Explanatory Continuum Indicator Summary 2 tool. Studies of any design reporting on implementation were included in a thematic synthesis using the Consolidated Framework for Implementation Research to identify barriers to and facilitators of implementation.
RESULTS
Overall, 53 reports, representing 29 interventions, were included in the review. Most interventions (27/29, 93%) focused on informal cancer or dementia caregivers. In total, 14 reports were included in the qualitative comparative analysis, exploring conditions including the presence of peer or professional support and key persuasive design features. Low consistency and coverage prevented the determination of condition sets sufficient for intervention effectiveness. Overall, 44 reports were included in the thematic synthesis, and 152 barriers and facilitators were identified, with the majority related to the intervention and individual characteristic domains of the Consolidated Framework for Implementation Research. Implementation barriers and facilitators in the inner setting (eg, organizational culture) and outer setting (eg, external policies and resources) domains were largely unexplored.
CONCLUSIONS
e-Mental health interventions for informal caregivers tend to be well-designed, with several barriers to and facilitators of implementation identified related to the intervention and individual user characteristics. Future work should focus on exploring the views of stakeholders involved in implementation to determine barriers to and facilitators of implementing e-mental health interventions for informal caregivers, focusing on inner and outer setting barriers and facilitators.
TRIAL REGISTRATION
PROSPERO (International Prospective Register of Systematic Reviews) CRD42020155727; https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020155727.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.1136/bmjopen-2019-035406.
PubMed: 36314782
DOI: 10.2196/41891 -
JAMA Network Open Mar 2024Platform trials have become increasingly common, and evidence is needed to determine how this trial design is actually applied in current research practice.
IMPORTANCE
Platform trials have become increasingly common, and evidence is needed to determine how this trial design is actually applied in current research practice.
OBJECTIVE
To determine the characteristics, progression, and output of randomized platform trials.
EVIDENCE REVIEW
In this systematic review of randomized platform trials, Medline, Embase, Scopus, trial registries, gray literature, and preprint servers were searched, and citation tracking was performed in July 2022. Investigators were contacted in February 2023 to confirm data accuracy and to provide updated information on the status of platform trial arms. Randomized platform trials were eligible if they explicitly planned to add or drop arms. Data were extracted in duplicate from protocols, publications, websites, and registry entries. For each platform trial, design features such as the use of a common control arm, use of nonconcurrent control data, statistical framework, adjustment for multiplicity, and use of additional adaptive design features were collected. Progression and output of each platform trial were determined by the recruitment status of individual arms, the number of arms added or dropped, and the availability of results for each intervention arm.
FINDINGS
The search identified 127 randomized platform trials with a total of 823 arms; most trials were conducted in the field of oncology (57 [44.9%]) and COVID-19 (45 [35.4%]). After a more than twofold increase in the initiation of new platform trials at the beginning of the COVID-19 pandemic, the number of platform trials has since declined. Platform trial features were often not reported (not reported: nonconcurrent control, 61 of 127 [48.0%]; multiplicity adjustment for arms, 98 of 127 [77.2%]; statistical framework, 37 of 127 [29.1%]). Adaptive design features were only used by half the studies (63 of 127 [49.6%]). Results were available for 65.2% of closed arms (230 of 353). Premature closure of platform trial arms due to recruitment problems was infrequent (5 of 353 [1.4%]).
CONCLUSIONS AND RELEVANCE
This systematic review found that platform trials were initiated most frequently during the COVID-19 pandemic and declined thereafter. The reporting of platform features and the availability of results were insufficient. Premature arm closure for poor recruitment was rare.
Topics: Humans; Pandemics; COVID-19; Cognition; Data Accuracy; Medical Oncology
PubMed: 38506807
DOI: 10.1001/jamanetworkopen.2024.3109 -
PloS One 2019The NICE clinical guidelines on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on the results of randomized controlled...
INTRODUCTION
The NICE clinical guidelines on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on the results of randomized controlled trials (RCTs), which may not be studies with a pragmatic design, leading to uncertainty on applicability or recommendations to everyday clinical practice.
AIM
To assess the level of pragmatism of the evidence used to develop the NICE guideline for psychosocial interventions in psychoses.
MATERIAL AND METHODS
We conducted a systematic and critical appraisal of RCTs used to develop the 'psychological therapy and psychosocial interventions' section of the NICE guideline on the treatment and management of psychosis and schizophrenia in adults, published in 2014. For each study we assessed pragmatism using the pragmatic-explanatory continuum indicator summary-2 (PRECIS-2) and the Cochrane risk of bias tool. The mean score of PRECIS-2, averaging across nine domains, was calculated to describe the level of pragmatism of each individual study.
RESULTS
A total of 143 studies were included in the analysis. Based on the PRECIS-2 tool, 16.8% were explanatory, 33.6% pragmatic, and 49.7% were rated in an intermediate category. Compared to explanatory studies, pragmatic studies showed a lower risk of bias. Additionally, pragmatism did not significantly improve over time, and no associations were found between pragmatism and a number of trial characteristics. However, studies with a UK leading investigator had the highest mean score of pragmatism. Cognitive behavioural therapy (CBT), art therapy, family intervention, psychoeducation, and adherence therapy, showed the higher average pragmatism scores.
CONCLUSIONS
Two third of studies used to produce NICE recommendations on psychosocial interventions for the treatment of schizophrenia and psychosis in adults are based on studies that did not employ a pragmatic design.
Topics: Government Agencies; Humans; Practice Guidelines as Topic; Pragmatic Clinical Trials as Topic; Psychiatric Rehabilitation; Psychotic Disorders; Research Design; Schizophrenia; United Kingdom
PubMed: 31550279
DOI: 10.1371/journal.pone.0222891 -
The Cochrane Database of Systematic... Oct 2021Globally, about 6% of children are born with a serious birth defect of genetic or partially genetic origin. Carrier screening or testing is one way to identify couples... (Review)
Review
BACKGROUND
Globally, about 6% of children are born with a serious birth defect of genetic or partially genetic origin. Carrier screening or testing is one way to identify couples at increased risk of having a child with an autosomal recessive condition. The most common autosomal recessive conditions are thalassaemia, sickle cell disease, cystic fibrosis and Tay-Sachs disease, with higher carrier rates in high-risk populations of specific ancestral backgrounds. Identifying and counselling couples at genetic risk of the conditions before pregnancy enables them to make fully informed reproductive decisions, with some of these choices not being available if testing is only offered in an antenatal setting. This is an update of a previously published review.
OBJECTIVES
To assess the effectiveness of systematic preconception genetic risk assessment to enable autonomous reproductive choice and to improve reproductive outcomes in women and their partners who are both identified as carriers of thalassaemia, sickle cell disease, cystic fibrosis and Tay-Sachs disease in healthcare settings when compared to usual care.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Trials Registers. Date of latest search of the registers: 04 August 2021. In addition, we searched for all relevant trials from 1970 (or the date at which the database was first available if after 1970) to date using electronic databases (MEDLINE, Embase, CINAHL, PsycINFO), clinical trial databases (National Institutes of Health, Clinical Trials Search portal of the World Health Organization, metaRegister of controlled clinical trials), and hand searching of key journals and conference abstract books from 1998 to date (European Journal of Human Genetics, Genetics in Medicine, Journal of Community Genetics). We also searched the reference lists of relevant articles, reviews and guidelines and also contacted subject experts in the field to request any unpublished or other published trials. Date of latest search of all these sources: 25 June 2021. SELECTION CRITERIA: Any randomised controlled trials (RCTs) or quasi-RCTs (published or unpublished) comparing reproductive outcomes of systematic preconception genetic risk assessment for thalassaemia, sickle cell disease, cystic fibrosis and Tay-Sachs disease when compared to usual care.
DATA COLLECTION AND ANALYSIS
We identified 37 papers, describing 22 unique trials which were potentially eligible for inclusion in the review. However, after assessment, we found no RCTs of preconception genetic risk assessment for thalassaemia, sickle cell disease, cystic fibrosis and Tay-Sachs disease.
MAIN RESULTS
No RCTs of preconception genetic risk assessment for thalassaemia, sickle cell disease, cystic fibrosis and Tay-Sachs disease are included. A trial identified earlier has published its results and has subsequently been listed as excluded in this review.
AUTHORS' CONCLUSIONS
As there are no RCTs of preconception genetic risk assessment for thalassaemia, sickle cell disease, cystic fibrosis, or Tay-Sachs disease included in either the earlier or current versions of this review, we recommend considering potential non-RCTs studies (for example prospective cohorts or before-and-after studies) for future reviews. While RCTs are desirable to inform evidence-based practice and robust recommendations, the ethical, legal and social implications associated with using this trial design to evaluate the implementation of preconception genetic risk assessment involving carrier testing and reproductive autonomy must also be considered. In addition, rather than focusing on single gene-by-gene carrier testing for specific autosomal-recessive conditions as the intervention being evaluated, preconception expanded genetic screening should also be included in future searches as this has received much attention in recent years as a more pragmatic strategy. The research evidence for current international policy recommendations is limited to non-randomised studies.
Topics: Anemia, Sickle Cell; Cystic Fibrosis; Female; Humans; Risk Assessment; Tay-Sachs Disease; Thalassemia
PubMed: 34634131
DOI: 10.1002/14651858.CD010849.pub4 -
The Journal of Nutrition Jun 2020As human milk (HM) composition varies by time and across even a single feed, methods of sample collection can significantly affect the results of compositional analyses...
BACKGROUND
As human milk (HM) composition varies by time and across even a single feed, methods of sample collection can significantly affect the results of compositional analyses and complicate comparisons between studies.
OBJECTIVE
The aim was to compare the results obtained for HM macronutrient composition between studies utilizing different sampling methodologies. The results will be used as a basis to identify the most reliable HM sampling approach.
METHODS
EMBASE, MEDLINE/PubMed, Cochrane Library, Scopus, Web of Science, and ProQuest databases were searched for relevant articles. Observational and interventional studies were included, and at least 2 authors screened studies and undertook data extraction. Quality assessment was conducted using the Newcastle-Ottawa scale and previously published pragmatic score.
RESULTS
A total of 5301 publications were identified from our search, of which 101 studies were included (n = 5049 breastfeeding women). Methods used for HM collection were divided into 3 categories: collection of milk from all feeds over 24 h (32 studies, n = 1309 participants), collection at one time point (62 studies, n = 3432 participants), and "other methods" (7 studies, n = 308 participants). Fat and protein concentrations varied between collection methods within lactation stage, but there were no obvious differences in lactose concentrations. There was substantial variability between studies in other factors potentially impacting HM composition, including stage of lactation, gestational age, and analytical method, which complicated direct comparison of methods.
CONCLUSIONS
This review describes the first systematic evaluation of sampling methodologies used in studies reporting HM composition and highlights the wide range of collection methods applied in the field. This information provides an important basis for developing recommendations for best practices for HM collection for compositional analysis, which will ultimately allow combination of information from different studies and thus strengthen the body of evidence relating to contemporary HM composition. This trial was registered at PROSPERO as CRD42017072563, https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42017072563.
Topics: Humans; Milk, Human; Nutrients; Specimen Handling
PubMed: 32240307
DOI: 10.1093/jn/nxaa059