Emergency transportation interventions for reducing adverse pregnancy outcomes in low- and middle-income countries: a systematic review protocol

BACKGROUND: Transportation interventions seek to decrease delay in reaching a health facility for emergency obstetric care and are, thus, believed to contribute to reductions in such adverse pregnancy and childbirth outcomes as maternal deaths, stillbirths, and neonatal mortality in low- and middle-income countries (LMICs). However, there is limited empirical evidence to support this hypothesis. The objective of the proposed review is to summarize and critically appraise evidence regarding the effect of emergency transportation interventions on outcomes of labor and delivery in LMICs. METHODS: The following databases will be searched from inception to March 31, 2018: MEDLINE/PubMed, EMBASE, Web of Science, EBSCO (PsycINFO and CINAHL), the Cochrane Pregnancy and Child Birth Group’s Specialized Register, and the Cochrane Central Register of Controlled Trials. We will search for studies in the grey literature through Google and Google Scholar. We will solicit unpublished reports from such relevant agencies as United Nations Fund for Population Activities (UNFPA), the World Health Organization (WHO), the United Nations Children’s Fund (UNICEF), the United States Agency for International Development (USAID), and the United Kingdom Department for International Development (DfID) among others. Data generated from the search will be managed using Endnote Version 7. We will perform quantitative data synthesis if studies are homogenous in characteristics and provide adequate outcome data for meta-analysis. Otherwise, data will be synthesized, using the narrative synthesis approach. DISCUSSION: Among the many barriers that women in LMICs face in accessing life-saving interventions during labor and delivery, lack of access to emergency transportation is particularly important. This review will provide a critical summary of evidence regarding the impact of transportation interventions on outcomes of pregnancy and childbirth in LMICs. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42017080092. This protocol is registered in PROSPERO (ID: CRD42017080092) and will follow the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P) guidelines (Additional file 1). Quasi-randomized controlled and randomized controlled trials that assessed the effect of transportation interventions on pregnancy outcomes in LMICs will be included. If there is paucity of controlled experimental studies, we will include controlled before-and-after studies and cohort studies with control. The study population consists of women in the prenatal, intrapartum, or post-natal phase of pregnancy with an obstetric complication, who were referred from the community or from a primary health care center to a higher-level facility that can provide emergency obstetric care. The types of intervention consist of all financing schemes or in-kind initiatives that enable poor pregnant women to overcome barriers of transportation to health facilities for emergency obstetric care in the prenatal period, during labor, delivery, or up to 42 days after delivery (postpartum period). Such interventions include programs that provide ground or water transportation (e.g., bicycle, motorcycle, oxcart, ambulance, boats) where none existed prior or that provide vouchers/subsidies, loans, or sets up a system of pooled funds or in-kind support for transportation to health facilities for needed emergency obstetric care during labor, delivery, or within the postpartum period. No transportation intervention for emergency obstetric care. Primary outcomes will encompass mortality (stillbirth, maternal mortality, and neonatal mortality). Secondary outcomes will include reduced delay in decision to seek care, improved referral rates, reduced time taken to reach appropriate healthcare facility, improved facility delivery rates, and met need for emergency obstetric care (i.e., receipt of emergency obstetric care by those that needed it). This review will be restricted to studies conducted in countries designated as low and middle income according to the World Bank’s classification [44]. This review will exclude (1) studies conducted outside LMICs, (2) observational studies without a control arm, and (3) interventions in refugee camps and conflict-affected settings. We will search the following databases from inception to March 31, 2018: MEDLINE/PubMed, EMBASE, Web of Science, EBSCO (PsycINFO and CINAHL), SCIELO, LILACS, JSTOR, POPLINE, the Cochrane Pregnancy and Child Birth Group’s Specialized Register, and the Cochrane Central Register of Controlled Trials. We will use a three-step approach for the search strategy. An initial limited search of MEDLINE using PubMed will be undertaken followed by analysis of the text contained in the title and abstract, and of the index terms used to describe the articles. A second search using all identified keywords and index terms will then be undertaken across all included databases. We will search for unpublished studies in the grey literature through Open Grey, Google, Google Scholar, relevant conference abstracts, and Clinical Trials.gov. We will solicit unpublished reports from multilateral organizations (WHO, UNICEF, UNFPA, World Bank), bilateral agencies, and non-governmental organizations (NGOs) whose programs may include interventions for prevention of adverse pregnancy outcomes. Additionally, we will screen reference lists of included studies for potentially eligible studies. The search will be coordinated by a librarian and will not be limited by language or status of publication. The search strategy will first be formulated in PubMed and adapted for other search databases. Examples of terms and concepts that will be searched individually and in combination (Table 1) include ((“Labor, Obstetric”[Mesh] OR “Delivery, Obstetric”[Mesh]) AND “Transportation of Patients”[Mesh]) AND (“mortality”[Subheading] OR “mortality”[All Fields] OR “mortality”[Mesh])) AND (“Evaluation Studies as Topic”[Mesh] OR “Evaluation Studies”, OR “Program Evaluation”[Mesh] OR “Health Care Evaluation Mechanisms”[Mesh] OR “Health Care Quality, Access, and Evaluation”[Mesh] OR “Health Services Research”[Mesh] OR “Process Assessment Health Care”[Mesh] OR “Emergency Medicine”[MeSH]), “Parturition”[Mesh] “Pregnan*” OR “Labor” OR “Birth” OR “Labour” OR “Childbirth” OR “Deliver*”, “Low-Income Economies”, OR “Low-income country”, OR “Low-income countries”, OR “Lower-Middle-Income Economies”, OR “Resource-limited Setting*”, OR “Resource-poor settings”, OR “Poor countries” OR “Middle-income countries”, OR “Upper-Middle-Income Economies”, “transport*” OR “Transport* scheme” OR “Transport* system” OR “Voucher” OR “Loan” OR “Fund” OR “Revolving fund*” OR “Community financing”. All references will be managed using EndNote Version 7. Search strategy for identification of studies A checklist (Table 2) of eligibility characteristics (type of study population, intervention, comparison, and study design (PICOS) will be used to screen studies for inclusion. First, two reviewers (EE and JC) will independently screen titles and abstracts of identified studies to assess their eligibility for inclusion. Second, EE and JC will screen the full texts from the first step to make a final determination regarding each study’s eligibility. Where there are uncertainties regarding eligibility, JE and MM will be consulted. Eligibility screening form NOTE: A) include if all is “YES”. B) Exclude if 2A, 2B, 3A, 5A are “NO”. C) Otherwise “ UNCLEAR” *Note that absence of outcome measure is not an exclusion criterion at this stage of eligibility screening; simply indicate outcomes assessed in each included study Two reviewers (JE and HA) will assess the quality of included studies using the risk of bias criteria for randomized controlled trials, non-randomized controlled trials, and controlled before-and-after studies developed by the Cochrane Effective Practice and Organization of Care (EPOC) as an adaptation of the Cochrane Collaboration’s tool for assessment of risk of bias [45]. Disagreements between the two assessors will be resolved by discussion and consensus, with arbitration by a third reviewer as required. In line with EPOC guidelines, each criterion will be scored as “low risk,” “unclear risk,” or “high risk” (Table 3). A study will be considered to be of low risk if all EPOC risk of bias criteria are scored as “yes,” “unclear risk of bias” if one or more criteria are scored as “unclear,” and “high risk of bias” if the study is scored “no” on one or more key criteria. Finally, the GRADE approach will be used to determine the quality of evidence for the main outcomes. The GRADE is process for rating the quality of the best available evidence developed by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) Working Group [46]. As shown in Table 4, the GRADE approach uses results of four criteria to assess the quality of the body of evidence derived from a systematic review. Factors taken into consideration in the grading of evidence include study bias levels, consistency of results, directness of results, and precision of results. Methodological quality of included studies GRADE quality of evidence grades Two reviewers (IA and HA) will independently extract data from each eligible study, using the Cochrane Collaboration’s standard data extraction form [47]. We will resolve differences through discussion and consensus among all reviewers. We will extract data on study setting, design, participants’ characteristics, interventions, controls, and duration of follow-up. We will also extract data on sample size, age, and data collection methods. Where possible, we will obtain qualitative information on context and potential confounding. We will obtain data on cost if available. We will collect data on the primary outcome, mortality (stillbirth, maternal mortality, and neonatal mortality), and secondary outcomes, access to care (reduced delay accessing care, time taken to access care, or other measures of reduction in delay in accessing case), care-seeking behaviors, referral rates, facility delivery rates, cost, and cost-effectiveness of interventions. Where necessary, we will contact authors of included studies for additional information or missing data. This study will not require approval from the Internal Review Board. The proposed study is a secondary analysis of peer-reviewed publications. No human subjects will be directly involved. We will perform quantitative data synthesis where studies are homogenous in characteristics and provide adequate outcome data for meta-analysis. Review Manager (version 5.3) will be utilized to perform fixed or random effect model meta-analysis. To detect statistical heterogeneity across included studies, we will conduct chi-square (χ2) and I-square (I2) tests. Significant heterogeneity will be determined by χ2 test with p value of < 0.1; heterogeneity will be adjudged to increase magnitude as I2 percentage point increases towards 100%. For sensitivity analysis, we will examine the residuals and chi-square components of estimates of effects and assess the effect of deleting each study in turn. In this case, where a statistically significant result depends on a single study, we will assess that study thoroughly with regard to sources of heterogeneity. We will perform meta-regression to adjust for potential confounding in multiple/mixed intervention studies, if we find sufficient number of eligible studies with these characteristics. Meta-analysis will not be performed if studies show marked heterogeneity (if p > 0.1). In addition, we will not perform meta-analysis if there are marked methodological variations, e.g., in types of modes of delivery of intervention. To synthesize quantitative data, we will undertake narrative synthesis, following the guidelines for conducting narrative synthesis in systematic reviews by Popay et al. [48].