A systematic review of methodological approaches for evaluating real-world effectiveness of COVID-19 vaccines: Advising resource-constrained settings

Real-world effectiveness studies are important for monitoring performance of COVID-19 vaccination programmes and informing COVID-19 prevention and control policies. We aimed to synthesise methodological approaches used in COVID-19 vaccine effectiveness studies, in order to evaluate which approaches are most appropriate to implement in low- and middle-income countries (LMICs). For this rapid systematic review, we searched PubMed and Scopus for articles published from inception to July 7, 2021, without language restrictions. We included any type of peer-reviewed observational study measuring COVID-19 vaccine effectiveness, for any population. We excluded randomised control trials and modelling studies. All data used in the analysis were extracted from included papers. We used a standardised data extraction form, modified from STrengthening the Reporting of OBservational studies in Epidemiology (STROBE). Study quality was assessed using the REal Life EVidence AssessmeNt Tool (RELEVANT) tool. This study is registered with PROSPERO, CRD42021264658. Our search identified 3,327 studies, of which 42 were eligible for analysis. Most studies (97.5%) were conducted in high-income countries and the majority assessed mRNA vaccines (78% mRNA only, 17% mRNA and viral vector, 2.5% viral vector, 2.5% inactivated vaccine). Thirty-five of the studies (83%) used a cohort study design. Across studies, short follow-up time and limited assessment and mitigation of potential confounders, including previous SARS-CoV-2 infection and healthcare seeking behaviour, were major limitations. This review summarises methodological approaches for evaluating real-world effectiveness of COVID-19 vaccines and highlights the lack of such studies in LMICs, as well as the importance of context-specific vaccine effectiveness data. Further research in LMICs will refine guidance for conducting real-world COVID-19 vaccine effectiveness studies in resource-constrained settings.

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A Systematic Review of Methodological Approaches for Evaluating Real-World Effectiveness of Covid-19 Vaccines: Advising Resource-Constrained Settings

SSRN Electronic Journal ◽

10.2139/ssrn.3900521 ◽

2021 ◽

Author(s):

Yot Teerawattananon ◽

Thunyarat Anothaisintawee ◽

Chatkamol Pheerapanyawaranun ◽

Siobhan Botwright ◽

Katika Akksilp ◽

...

Keyword(s):

Systematic Review ◽

Real World ◽

Resource Constrained ◽

Methodological Approaches

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Predicting the Effectiveness of the Pfizer-BioNTech BNT162b2 Vaccine from SARS-CoV-2 Variants Neutralisation Data

10.1101/2021.09.06.21263160 ◽

2021 ◽

Author(s):

Oleg Volkov ◽

Svetlana Borozdenkova ◽

Alexander Gray

Keyword(s):

Real Life ◽

Vaccine Effectiveness ◽

Vaccine Protection ◽

Life Effectiveness ◽

Correlates Of Protection ◽

Antibody Titres ◽

Effectiveness Studies

Modelling frameworks for vaccine protection are sorely needed to fight the Covid-19 pandemic with vaccines. We propose such a framework for the BNT162b2 and potentially other vaccines. It identifies correlates of protection based on live SARS-CoV-2 variants neutralising antibody titres from vaccinated individuals. We applied it to predict vaccine effectiveness in overall populations and age subgroups. It was validated by predicting effectiveness against the B.1.167.2 (Delta) variant. The predictions, of 51.7% (34%, 69%) after one and of 88.6% (76%, 97%) after two vaccine doses, were close to the corresponding means, 49% and 85.4%, of observations in real-life effectiveness studies. We illustrate its applications to inform decisions, such as about the doses and timing of vaccine boosters.

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Evidence on Respectful Maternity Care For Adolescents: A Systematic Review Protocol

10.21203/rs.3.rs-67728/v2 ◽

2021 ◽

Author(s):

Helen H Habib ◽

Jefferson Mwaisaka ◽

Kwasi Torpey ◽

Ernest Tei Maya ◽

Augustine Ankomah

Keyword(s):

Systematic Review ◽

Quality Assessment ◽

Maternity Care ◽

Assessment Tool ◽

Data Extraction ◽

Respectful Maternity Care ◽

Great Promise ◽

Systematic Review Protocol ◽

Health And Human Rights ◽

Review Protocol

Abstract Background: Intrapartum mistreatment of women is a globally rising public health and human rights phenomenon. The issue reportedly has severe maternal and neonatal outcomes including mortality, and generally leads to a decreased satisfaction with maternity care. Intrapartum mistreatment, despite being ubiquitous, indicates higher incidence among adolescent parturients who are simultaneously at a higher risk of maternal morbidity and mortality. Studies have suggested that Respectful Maternity Care (RMC) interventions reduce intrapartum mistreatment and improve clinical outcomes for women and neonates in general. However, evidence on the effect of RMC on adolescents is unclear. Hence the specific aim of this study is to synthesise the available evidence relating to the provision of RMC for adolescents during childbirth.Methods: The methodology of the proposed systematic review follows the procedural guideline depicted in the preferred reporting items for systematic review protocol. The review will include all observational and intervention studies conducted between January 1, 1990 and April 30, 2020. Electronic databases including MEDLINE, PubMed, ScienceDirect, Cochrane, CINAHL, PsycINFO, Scopus, Google Scholar, and Web of Science will be searched to retrieve available studies using the appropriate search strings. The search results will be appraised with Joanna Briggs Institute quality assessment tool. The selection of relevant studies, data extraction, and quality assessment of individual studies will be carried out by two independent authors. Results: A systematic narrative synthesis of the resultant studies will be done, and the relevant themes extracted. Findings will also be summarised in tables.Discussion: Respectful Maternity Care for adolescents holds great promise for improved maternal and neonatal care. However, there is a gap in knowledge on the interventions that work and the extent of their effectiveness. Findings from this study will be beneficial in improving Adolescents Sexual and Reproductive Health and Rights (ASRHR) and reducing maternal mortality, especially for adolescents.Systematic review registration: PROSPERO (Submitted 21 August 2020)

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Differences In Chronic Pain Prevalence Between Men And Women At Mid-Life: A Systematic Review Protocol

10.21203/rs.3.rs-1192864/v1 ◽

2021 ◽

Author(s):

Catherine Borra ◽

Rebecca Hardy

Keyword(s):

Systematic Review ◽

Chronic Pain ◽

Life Course ◽

Assessment Tool ◽

Social Research ◽

Data Extraction ◽

Meta Analysis ◽

Men And Women ◽

Prevalence Studies ◽

The Life Course

Abstract Background: Epidemiological literature has revealed differences in chronic pain (CP) prevalence in men and women. Women have been found to be more likely to develop CP compared to men at different points of the life-course, such as childhood and old age. Less is known about differences in prevalence by sex during mid-life. While CP is most prevalent later in life, biological and physical changes in mid-life may predispose to an earlier differentiation in CP distribution – for example due to the menopause. The aim of this study is to describe the prevalence of CP at midlife in men and women, and to identify how these differences relate to results pertaining to other periods in the life-course. Methods: This systematic review follows PRISMA guidelines. An electronic search will identify appropriate studies in the following databases: MEDLINE, to be accessed through Web of Science; and EMBASE, AMED and PSYCHinfo to be accessed through OVID. Two reviewers will independently screen each title and abstract and subsequently each full text following the inclusion criteria outlined in this protocol. The reference lists of eligible papers will also be screened to identify any further eligible studies. Any inconsistencies between reviewer decisions will be resolved through discussion. Studies eligible for data extraction will report estimates of CP prevalence, of prevalence for each sex, and difference in prevalence between sexes. Two reviewers will conduct data extraction using a standardised data extraction form. Quality assessment will be conducted using a risk of bias assessment tool for prevalence studies. The findings will be reported in a narrative synthesis and will comment on expected heterogeneity, following the Social Research Council Methods Programme guidelines. A random effects meta-analysis will be conducted where the reviewers can justify combining results.Discussion: This review will summarise the prevalence of CP in men and women at mid-life, based on existing evidence. It is expected that the results will identify gaps in knowledge and areas for further research.Systematic review registration: PROSPERO: CRD42021295895

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Comparison of intravitreal dexamethasone implant and anti-VEGF drugs in the treatment of retinal vein occlusion-induced oedema: a meta-analysis and systematic review

BMJ Open ◽

10.1136/bmjopen-2019-032128 ◽

2020 ◽

Vol 10 (6) ◽

pp. e032128

Author(s):

Shuai Ming ◽

Kunpeng Xie ◽

Mingzhu Yang ◽

Huijuan He ◽

Ya Li ◽

...

Keyword(s):

Systematic Review ◽

Retinal Vein Occlusion ◽

Real World ◽

Meta Analysis ◽

Real Life ◽

Cochrane Library ◽

Efficacy And Safety ◽

Vein Occlusion ◽

Anti Vegf ◽

Intravitreal Dexamethasone

ObjectiveTo compare the efficacy and safety of intravitreal dexamethasone (DEX) implant and anti-vascular endothelial growth factor (anti-VEGF) agents in the treatment of macular oedema secondary to retinal vein occlusion (RVO).DesignSystematic review and meta-analysis based on Grading of Recommendations Assessment, Development and Evaluation (GRADE).Data sourcesPubMed, Cochrane Library and ClinicalTrials.gov registry were searched from inception to 10 December 2019, without language restrictions.Eligibility criteriaRandomised controlled trials (RCTs) and real-world observation studies comparing the efficacy of DEX implant and anti-VEGF agents for the treatment of patients with RVO, naïve or almost naïve to both arms, were included.Data extraction and synthesisTwo reviewers independently extracted data for mean changes in best-corrected visual acuity (BCVA), central subfield thickness (CST) and product safety. Review Manager V.5.3 and GRADE were used to synthesise the data and validate the evidence, respectively.ResultsFour RCTs and 12 real-world studies were included. An average lower letter gain in BCVA was determined for the DEX implant (mean difference (MD) = −6.59; 95% CI −8.87 to −4.22 letters) administered at a retreatment interval of 5–6 months. Results were similar (MD6 months=−12.68; 95% CI −21.98 to −3.37 letters; MD12 months=−9.69; 95% CI −12.01 to −7.37 letters) at 6 and 12 months. The DEX implant resulted in comparable or marginally less CST reduction at months 6 and 12 but introduced relatively higher risks of elevated intraocular pressure (RR=3.89; 95% CI 2.16 to 7.03) and cataract induction (RR=5.22; 95% CI 1.67 to 16.29). Most real-life studies reported an insignificant numerical gain in letters for anti-VEGF drugs relative to that for DEX implant. However, the latter achieved comparable efficacy with a 4-month dosage interval.ConclusionCompared with anti-VEGF agents, DEX implant required fewer injections but had inferior functional efficacy and safety. Real-life trials supplemented the efficacy data for DEX implant.

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Machine Learning Applied to Diagnosis of Human Diseases: A Systematic Review

Applied Sciences ◽

10.3390/app10155135 ◽

2020 ◽

Vol 10 (15) ◽

pp. 5135

Author(s):

Nuria Caballé-Cervigón ◽

José L. Castillo-Sequera ◽

Juan A. Gómez-Pulido ◽

José M. Gómez-Pulido ◽

María L. Polo-Luque

Keyword(s):

Machine Learning ◽

Systematic Review ◽

English Language ◽

Data Extraction ◽

Real Life ◽

Human Diseases ◽

Machine Learning Techniques ◽

Comprehensive Overview ◽

Advantages And Disadvantages ◽

Journal Citation Reports

Human healthcare is one of the most important topics for society. It tries to find the correct effective and robust disease detection as soon as possible to patients receipt the appropriate cares. Because this detection is often a difficult task, it becomes necessary medicine field searches support from other fields such as statistics and computer science. These disciplines are facing the challenge of exploring new techniques, going beyond the traditional ones. The large number of techniques that are emerging makes it necessary to provide a comprehensive overview that avoids very particular aspects. To this end, we propose a systematic review dealing with the Machine Learning applied to the diagnosis of human diseases. This review focuses on modern techniques related to the development of Machine Learning applied to diagnosis of human diseases in the medical field, in order to discover interesting patterns, making non-trivial predictions and useful in decision-making. In this way, this work can help researchers to discover and, if necessary, determine the applicability of the machine learning techniques in their particular specialties. We provide some examples of the algorithms used in medicine, analysing some trends that are focused on the goal searched, the algorithm used, and the area of applications. We detail the advantages and disadvantages of each technique to help choose the most appropriate in each real-life situation, as several authors have reported. The authors searched Scopus, Journal Citation Reports (JCR), Google Scholar, and MedLine databases from the last decades (from 1980s approximately) up to the present, with English language restrictions, for studies according to the objectives mentioned above. Based on a protocol for data extraction defined and evaluated by all authors using PRISMA methodology, 141 papers were included in this advanced review.

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Prognostic models for predicting in-hospital paediatric mortality in resource-limited countries: a systematic review

BMJ Open ◽

10.1136/bmjopen-2019-035045 ◽

2020 ◽

Vol 10 (10) ◽

pp. e035045

Author(s):

Morris Ogero ◽

Rachel Jelagat Sarguta ◽

Lucas Malla ◽

Jalemba Aluvaala ◽

Ambrose Agweyu ◽

...

Keyword(s):

Systematic Review ◽

Low Income ◽

Assessment Tool ◽

Data Extraction ◽

Model Development ◽

Risk Of Bias ◽

Prognostic Models ◽

Risk Scores ◽

Eligibility Criteria ◽

Bias Assessment

ObjectivesTo identify and appraise the methodological rigour of multivariable prognostic models predicting in-hospital paediatric mortality in low-income and middle-income countries (LMICs).DesignSystematic review of peer-reviewed journals.Data sourcesMEDLINE, CINAHL, Google Scholar and Web of Science electronic databases since inception to August 2019.Eligibility criteriaWe included model development studies predicting in-hospital paediatric mortality in LMIC.Data extraction and synthesisThis systematic review followed the Checklist for critical Appraisal and data extraction for systematic Reviews of prediction Modelling Studies framework. The risk of bias assessment was conducted using Prediction model Risk of Bias Assessment Tool (PROBAST). No quantitative summary was conducted due to substantial heterogeneity that was observed after assessing the studies included.ResultsOur search strategy identified a total of 4054 unique articles. Among these, 3545 articles were excluded after review of titles and abstracts as they covered non-relevant topics. Full texts of 509 articles were screened for eligibility, of which 15 studies reporting 21 models met the eligibility criteria. Based on the PROBAST tool, risk of bias was assessed in four domains; participant, predictors, outcome and analyses. The domain of statistical analyses was the main area of concern where none of the included models was judged to be of low risk of bias.ConclusionThis review identified 21 models predicting in-hospital paediatric mortality in LMIC. However, most reports characterising these models are of poor quality when judged against recent reporting standards due to a high risk of bias. Future studies should adhere to standardised methodological criteria and progress from identifying new risk scores to validating or adapting existing scores.PROSPERO registration numberCRD42018088599.

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Safety and efficiency of gasless laparoscopy: a systematic review protocol

Systematic Reviews ◽

10.1186/s13643-020-01365-y ◽

2020 ◽

Vol 9 (1) ◽

Author(s):

Haitham Shoman ◽

Simone Sandler ◽

Alexander Peters ◽

Ameer Farooq ◽

Magdalen Gruendl ◽

...

Keyword(s):

Systematic Review ◽

Assessment Tool ◽

Data Extraction ◽

Meta Analysis ◽

A Priori ◽

Risk Of Bias ◽

Conventional Laparoscopy ◽

Eligibility Criteria ◽

Gasless Laparoscopy ◽

Resource Setting

Abstract Background Gasless laparoscopy, developed in the early 1990s, was a means to minimize the clinical and financial challenges of pneumoperitoneum and general anaesthesia. It has been used in a variety of procedures such as in general surgery and gynecology procedures including diagnostic laparoscopy. There has been increasing evidence of the utility of gasless laparoscopy in resource limited settings where diagnostic imaging is not available. In addition, it may help save costs for hospitals. The aim of this study is to conduct a systematic review of the available evidence surrounding the safety and efficiency of gasless laparoscopy compared to conventional laparoscopy and open techniques and to analyze the benefits that gasless laparoscopy has for low resource setting hospitals. Methods This protocol is developed by following the Preferred Reporting Items for Systematic review and Meta-Analysis–Protocols (PRISMA-P). The PRISMA statement guidelines and flowchart will be used to conduct the study itself. MEDLINE (Ovid), Embase, Web of Science, Cochrane Central, and Global Index Medicus (WHO) will be searched and the National Institutes of Health Clinical Trials database. The articles that will be found will be pooled into Covidence article manager software where all the records will be screened for eligibility and duplicates removed. A data extraction spreadsheet will be developed based on variables of interest set a priori. Reviewers will then screen all included studies based on the eligibility criteria. The GRADE tool will be used to assess the quality of the studies and the risk of bias in all the studies will be assessed using the Cochrane Risk assessment tool. The RoB II tool will assed the risk of bias in randomized control studies and the ROBINS I will be used for the non-randomized studies. Discussion This study will be a comprehensive review on all published articles found using this search strategy on the safety and efficiency of the use of gasless laparoscopy. The systematic review outcomes will include safety and efficiency of gasless laparoscopy compared to the use of conventional laparoscopy or laparotomy. Trial registration The study has been registered in PROSPERO under registration number: CRD42017078338

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Determinants of antenatal care utilisation in sub-Saharan Africa: a systematic review

BMJ Open ◽

10.1136/bmjopen-2019-031890 ◽

2019 ◽

Vol 9 (10) ◽

pp. e031890 ◽

Cited By ~ 16

Author(s):

Ijeoma Nkem Okedo-Alex ◽

Ifeyinwa Chizoba Akamike ◽

Obumneme Benaiah Ezeanosike ◽

Chigozie Jesse Uneke

Keyword(s):

Systematic Review ◽

Antenatal Care ◽

Assessment Tool ◽

Unplanned Pregnancy ◽

Data Extraction ◽

Sub Saharan Africa ◽

Intersectoral Collaboration ◽

Geographical Access ◽

Sub Saharan ◽

Antenatal Visits

ObjectivesTo identify the determinants of antenatal care (ANC) utilisation in sub-Saharan Africa.DesignSystematic review.Data sourcesDatabases searched were PubMed, OVID, EMBASE, CINAHL and Web of Science.Eligibility criteriaPrimary studies reporting on determinants of ANC utilisation following multivariate analysis, conducted in sub-Saharan Africa and published in English language between 2008 and 2018.Data extraction and synthesisA data extraction form was used to extract the following information: name of first author, year of publication, study location, study design, study subjects, sample size and determinants. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses checklist for reporting a systematic review or meta-analysis protocol was used to guide the screening and eligibility of the studies. The Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies was used to assess the quality of the studies while the Andersen framework was used to report findings.Results74 studies that met the inclusion criteria were fully assessed. Most studies identified socioeconomic status, urban residence, older/increasing age, low parity, being educated and having an educated partner, being employed, being married and Christian religion as predictors of ANC attendance and timeliness. Awareness of danger signs, timing and adequate number of antenatal visits, exposure to mass media and good attitude towards ANC utilisation made attendance and initiation of ANC in first trimester more likely. Having an unplanned pregnancy, previous pregnancy complications, poor autonomy, lack of husband’s support, increased distance to health facility, not having health insurance and high cost of services negatively impacted the overall uptake, timing and frequency of antenatal visits.ConclusionA variety of predisposing, enabling and need factors affect ANC utilisation in sub-Saharan Africa. Intersectoral collaboration to promote female education and empowerment, improve geographical access and strengthened implementation of ANC policies with active community participation are recommended.

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Daily Practice Managing Resistant Multiple Sclerosis Spasticity With Delta-9-Tetrahydrocannabinol: Cannabidiol Oromucosal Spray: A Systematic Review of Observational Studies

Journal of Central Nervous System Disease ◽

10.1177/1179573519831997 ◽

2019 ◽

Vol 11 ◽

pp. 117957351983199 ◽

Cited By ~ 5

Author(s):

Katja Akgün ◽

Ute Essner ◽

Cordula Seydel ◽

Tjalf Ziemssen

Keyword(s):

Multiple Sclerosis ◽

Systematic Review ◽

Clinical Practice ◽

Real World ◽

Observational Studies ◽

Rating Scale ◽

Real Life ◽

Daily Practice ◽

Patient Characteristics ◽

Numeric Rating Scale

Background/purpose: Spasticity is one of the most common symptoms in people with multiple sclerosis (MS). Conventional anti-spasticity agents have limitations in their efficacy and tolerability. Delta-9-tetrahydrocannabinol: cannabidiol (THC:CBD) spray, a cannabinoid-based medicine, is approved as an add-on therapy for MS spasticity not adequately controlled by other anti-spasticity medications. The results from randomized controlled trials (RCTs) have demonstrated a reduction in the severity of spasticity and associated symptoms. However, RCTs do not always reflect real-life outcomes. We systematically reviewed the complementary evidence from non-interventional real-world studies. Methods: A systematic literature review was conducted to identify all non-RCT publications on THC:CBD spray between 2011 and 2017. Data on study design, patient characteristics, effectiveness, and safety outcomes were extracted from those publications meeting our inclusion criteria. Results: In total, we reviewed 14 real-world publications including observational studies and treatment registries. The proportion of patients reaching the threshold of minimal clinical important difference (MCID), with at least a 20% reduction of the spasticity Numeric Rating Scale (NRS) score after 4 weeks ranged from 41.9% to 82.9%. The reduction in the mean NRS spasticity score after 4 weeks was maintained over 6-12 months. The average daily dose was five to six sprays. Delta-9-tetrahydrocannabinol: cannabidiol was well tolerated in the evaluated studies in the same way as in the RCTs. No new or unexpected adverse events or safety signals were reported in everyday clinical practice. Conclusions: The data evaluated in this systematic review provide evidence for the efficacy and safety of THC:CBD in clinical practice and confirm results obtained in RCTs.

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