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Summary: Background: Health worker compliance with clinical guidelines is enhanced by digital clinical decision support at the point of care. The Palestinian public health system is implementing a digital maternal and child health eRegistry with clinical decision support. We aimed to compare the quality of antenatal care between clinics using the eRegistry and those using paper-based records. Methods: The eRegQual cluster-randomised controlled trial was done in primary health-care clinics offering routine antenatal care in the West Bank, Palestine. The intervention was the eRegistry with clinical decision support for antenatal care, implemented in District Health Information Systems 2 (DHIS2) Tracker software. 133 clinics forming 120 clusters were included and randomised; clusters were randomly assigned (1:1) to either the control (paper-based documentation) or intervention (eRegistry with clinical decision support) groups. The primary process outcomes were appropriate screening and management of anaemia, hypertension, and diabetes during pregnancy and foetal growth monitoring. The primary health outcome at delivery was a composite of moderate or severe anaemia; severe hypertension; large-for-gestational-age baby; malpresentation and small-for-gestational-age baby undetected before delivery. Data were analysed with mixed-effects logistic regression, accounting for clustering within clinics and pregnancies as appropriate. This trial is registered with the ISRCTN registry (ISRCTN18008445). Findings: Between Jan 15 and Sept 15, 2017, 3219 pregnant women received care in the intervention clinics (n=60 clusters) and 3148 pregnant women received care in the control primary health-care clinics (n=59 clusters). Compared with the control group, the intervention led to higher guideline adherence for screening and management of anaemia (1535 [28·9%] of 5320 vs 2297 [44·3%] of 5182; adjusted odds ratio [OR] 1·88 [95% CI 1·52–2·32]), hypertension (7555 [94·7%] of 7982 vs 7314 [96·6%] of 7569; adjusted OR 1·62 [95% CI 1·29–2·05]), and gestational diabetes (1726 (39·7%) of 4348 vs 2189 (50·7%) of 4321; adjusted OR 1·45 [95% CI 1·14–1·83]) at eligible antenatal contacts. Only 599 (9·4%) of 6367 women attended the full antenatal care schedule, and better care provision did not translate to fewer adverse health outcomes in the intervention clusters (700 cases; 21·7%) compared to the control clusters (688 cases; 21·9%; adjusted OR 0·99; 95% CI 0·87–1·12). Interpretation: Clinical decision support for antenatal care in the eRegistry was superior for most process outcomes but had no effect on the adverse health outcomes. The improvements in process outcomes strengthen the evidence for the WHO guideline for digital client tracking with clinical decision support in lower-middle-income settings. Digital health interventions to address gaps in attendance might help achieve effective coverage of antenatal care. Funding: European Research Council and Research Council of Norway. Translation: For the Arabic translation of the abstract see Supplementary Materials section.

BACKGROUND Digital health interventions have been shown to improve data quality and health services in low- and middle-income countries (LMICs). Nonetheless, in LMICs, systematic assessments of time saved with the use of digital tools are rare. We ran a set of cluster-randomized controlled trials as part of the implementation of a digital maternal and child health registry (eRegistry) in the West Bank, Palestine. OBJECTIVE In the eRegTime study, we compared time spent on health information management in clinics that use the eRegistry versus the existing paper-based documentation system. METHODS Intervention (eRegistry) and control (paper documentation) arms were defined by a stratified random subsample of primary health care clinics from the concurrent eRegQual trial. We used time-motion methodology to collect data on antenatal care service provision. Four observers used handheld tablets to record time-use data during one working day per clinic. We estimated relative time spent on health information management for booking and follow-up visits and on client care using mixed-effects linear regression. RESULTS In total, 22 of the 24 included clinics (12 intervention, 10 control) contributed data; no antenatal care visits occurred in the other two clinics during the study period. A total of 123 and 118 consultations of new pregnancy registrations and follow-up antenatal care visits were observed in the intervention and control groups, respectively. Average time spent on health information management for follow-up antenatal care visits in eRegistry clinics was 5.72 minutes versus 8.10 minutes in control clinics (adjusted relative time 0.69, 95% CI 0.60-0.79; PP=.85) for booking visits. The average time spent on documentation, a subcategory of health information management, was 5.50 minutes in eRegistry clinics versus 8.48 minutes in control clinics (adjusted relative time 0.68, 95% CI 0.56-0.83; PP=.27). CONCLUSIONS The eRegistry captures digital data at point of care during client consultations and generates automated routine reports based on the clinical data entered. Markedly less time (plausibly a saving of at least 18%) was spent on health information management in eRegistry clinics compared to those that use paper-based documentation. This is likely explained by the fact that the eRegistry requires lesser repetitive documentation work than paper-based systems. Adoption of eRegistry-like systems in comparable settings may save valuable and scarce health care resources. CLINICALTRIAL ISRCTN registry ISRCTN18008445; https://doi.org/10.1186/ISRCTN18008445 INTERNATIONAL REGISTERED REPORT RR2-10.2196/13653

Background This trial evaluates interventions that utilize data entered at point-of-care in the Palestinian maternal and child eRegistry to generate Quality Improvement Dashboards (QID) for healthcare providers and Targeted Client Communication (TCC) via short message service (SMS) to clients. The aim is to assess the effectiveness of the automated communication strategies from the eRegistry on improving attendance and quality of care for pregnant women. Methods This four-arm cluster randomized controlled trial will be conducted in the West Bank and the Gaza Strip, Palestine, and includes 138 clusters (primary healthcare clinics) enrolling from 45 to 3000 pregnancies per year. The intervention tools are the QID and the TCC via SMS, automated from the eRegistry built on the District Health Information Software 2 (DHIS2) Tracker. The primary outcomes are appropriate screening and management of anemia, hypertension, and diabetes during pregnancy and timely attendance to antenatal care. Primary analysis, at the individual level taking the design effect of the clustering into account, will be done as intention-to-treat. Discussion This trial, embedded in the implementation of the eRegistry in Palestine, will inform the use of digital health interventions as a health systems strengthening approach. Trial registration ISRCTN Registry, ISRCTN10520687. Registered on 18 October 2018

Background: This trial evaluates interventions that utilize data entered at point-of-care in the Palestinian maternal and child eRegistry to generate Quality Improvement Dashboards (QID) for healthcare providers and Targeted Client Communication (TCC) via short message service (SMS) to clients. The aim is to assess the effectiveness of the automated communication strategies from the eRegistry on improving attendance and quality of care for pregnant women.Methods: This four-arm cluster randomized controlled trial will be conducted in the West Bank and the Gaza Strip, Palestine, and includes 138 clusters (primary healthcare clinics) enrolling from 45 to 3000 pregnancies per year. The intervention tools are the QID and the TCC via SMS, automated from the eRegistry built on the District Health Information Software 2 (DHIS2) Tracker. The primary outcomes are appropriate screening and management of anemia, hypertension, and diabetes during pregnancy; and timely attendance to antenatal care. Primary analysis, at the individual-level taking the design effect of the clustering into account, will be done as intention-to-treat.Discussion: This trial, embedded in the implementation of the eRegistry in Palestine, will inform the use of digital health interventions as a health systems strengthening approach.Trial registration: ISRCTN, trial registration number: 10520687, registered 18 October 2018, http://www.isrctn.com/ISRCTN10520687

Additional file 2. Theories and concepts used in the design of the Targeted Client Communication (TCC) intervention

Background Targeted client communication (TCC) using text messages can inform, motivate and remind pregnant and postpartum women of timely utilization of care. The mixed results of the effectiveness of TCC interventions points to the importance of theory based interventions that are co-design with users. The aim of this paper is to describe the planning, development, and evaluation of a theory led TCC intervention, tailored to pregnant and postpartum women and automated from the Palestinian electronic maternal and child health registry. Methods We used the Health Belief Model to develop interview guides to explore women’s perceptions of antenatal care (ANC), with a focus on high-risk pregnancy conditions (anemia, hypertensive disorders in pregnancy, gestational diabetes mellitus, and fetal growth restriction), and untimely ANC attendance, issues predefined by a national expert panel as being of high interest. We performed 18 in-depth interviews with women, and eight with healthcare providers in public primary healthcare clinics in the West Bank and Gaza. Grounding on the results of the in-depth interviews, we used concepts from the Model of Actionable Feedback, social nudging and Enhanced Active Choice to compose the TCC content to be sent as text messages. We assessed the acceptability and understandability of the draft text messages through unstructured interviews with local health promotion experts, healthcare providers, and pregnant women. Results We found low awareness of the importance of timely attendance to ANC, and the benefits of ANC for pregnancy outcomes. We identified knowledge gaps and beliefs in the domains of low awareness of susceptibility to, and severity of, anemia, hypertension, and diabetes complications in pregnancy. To increase the utilization of ANC and bridge the identified gaps, we iteratively composed actionable text messages with users, using recommended message framing models. We developed algorithms to trigger tailored text messages with higher intensity for women with a higher risk profile documented in the electronic health registry. Conclusions We developed an optimized TCC intervention underpinned by behavior change theory and concepts, and co-designed with users following an iterative process. The electronic maternal and child health registry can serve as a unique platform for TCC interventions using text messages.

IntroductionHealth technology assessment (HTA) can play a key role in evidence-based decision-making. However, HTA requires resources that might be lacking in low-income settings. To test the feasibility of adapting existing evidence as part of the HTA process, this project evaluated the effectiveness and economic impact of breast cancer screening programs for women over 40 years in the West Bank, where mammography screening is provided for free in governmental clinics.MethodsWe conducted a search for systematic reviews, HTAs and guidelines in electronic databases. We included the most recent global systematic review and meta-analysis that fulfilled our inclusion criteria. The European Network for Health Technology Assessment (EUnetHTA) adaptation toolkit was used to guide adaptation and undertake a budget impact analysis of the economic impact of mammography screening. We build capacity by working as a team of HTA experts and first-time HTA researchers. The results were disseminated to raise awareness for HTA.ResultsThe European Commission Guidelines on Breast Cancer Screening were identified as most recent global systematic review with meta-analyses, out of 2,365 references. The adapted evidence may inform policies on screening in the West Bank. Our experience is that adaption requires extensive skills and resources, including finding, assessing, and adapting relevant evidence. The EUnetHTA toolkit is useful, but also adds to the workload. Furthermore, local stakeholder engagement is important in topic selection, to access information, and to contextualize global evidence to the local setting.ConclusionsThis study is currently ongoing, but preliminary findings show that producing an HTA by adapting existing evidence in resource-limited settings is feasible. There is a need for nuanced guidance on transferability of evidence from other settings. Future studies should investigate innovative methods to optimize the adaption process. Capacity building in adaptation is important to ensure the production of quality HTA products. Inclusion of local team members and stakeholders is important for future development of HTA in the region.

Background Targeted client communication using text messages can inform, motivate, and remind pregnant and postpartum women to use care in a timely way. The mixed results of previous studies of the effectiveness of targeted client communication highlight the importance of theory-based co-design with users. We planned, developed, and tested a theory-based intervention tailored to pregnant and postpartum women, to be automatically distributed via an electronic maternal and child health registry in occupied Palestinian territory. Methods We did 26 in-depth interviews with pregnant women and health-care providers in seven purposively selected public primary health-care clinics in the West Bank and Gaza to include clinics with different profiles. An interview guide was developed using the Health Belief Model to explore women's perceptions of high-risk conditions (anaemia, hypertension, diabetes, and fetal growth restriction) and timely attendance for antenatal care, as predefined by a national expert panel. We did thematic analyses of the interview data. Based on the results, we composed messages for a targeted client communication intervention, applying concepts from the Model of Actionable Feedback, social nudging, and enhanced active choice. We assessed the acceptability and understandability of the messages through unstructured interviews with local health promotion experts, health-care providers, and pregnant women. Findings The recurring themes indicated that most women were aware of the health consequences of anaemia, hypertension, and diabetes, but that they seldom associated these conditions with pregnancy. We identified knowledge gaps and low awareness of susceptibility to and severity of these complications and the benefits of timely antenatal care. The actionable messages were iteratively improved with stakeholder and end-user feedback after presenting the initial draft, and the messages deemed were understandable and acceptable based on reflections during unstructured assessment. Interpretation Following a stepwise iterative process by a theory-based approach and co-designing the intervention with users, we revealed elements critical to an efficacious targeted client communication intervention. A potential limitation of our study is that conducting in-depth interviews on several health conditions simultaneously might have reduced the depth of information we could have obtained. The strength of our study was that we assessed for, developed, and refined the intervention following recommended theoretical frameworks and best practices. The effectiveness of this intervention is under evaluation in a cluster-randomised trial (ISRCTN10520687). Funding European Research Council and Research Council of Norway.

Background Estimated dates of delivery have important consequences for clinical decisions during pregnancy and labour. The Electronic Maternal and Child Health Registry (MCH eRegistry) in Palestine includes antenatal care data and birth data from hospitals. Our objective was to compare computed best estimates of gestational age in the MCH eRegistry with the gestational ages recorded by health-care providers in hospital delivery units. Methods We obtained data for pregnant women in the West Bank registered in the MCH eRegistry from Jan 1, 2017 to March 31, 2017. Best estimates of gestational age in the registry are automated and based on a standard pregnancy duration of 280 days and ultrasound-based pregnancy dating before 20 weeks’ gestation or the woman's last menstrual period date. Hospital recorded gestational ages are reported by care providers in delivery units and are rounded to the nearest week. We calculated proportions of gestational ages (with 95% CIs) from both sources that fell into the categories of term, very preterm (24–32 weeks’ gestation), preterm (33–37 weeks), or post-term (>42 weeks). Findings 1924 women were included in the study. The median hospital recorded gestational age was 39 weeks (IQR 38–40 weeks) and according to MCH eRegistry estimates was 39 weeks and 5 days (IQR 38 weeks and 1 day to 40 weeks and 5 days). Proportions of very preterm, preterm, and post-term deliveries were higher based on MCH eRegistry estimates than on hospital recorded gestational ages (very preterm 3%, 95% CI 2–4 vs 2%, 1–2; preterm 6%, 5–7 vs 5%, 3–6 ; post-term 6%, 5–7 vs 1%, 1–2). Interpretation In addition to clinical care, the proportions of term, very preterm, preterm, and post-term births can have implications for public health monitoring. The proportion of deliveries within the normal range of term gestation was calculated to be higher by care providers in delivery units than by MCH eRegistry estimates. Extending the access of hospitals to information from antenatal care in the MCH e-Registry could improve continuity of data and better care for pregnant women. Funding European Research Council, Research Council of Norway.

Background Good quality data from health systems can benefit several stakeholders, including policy makers, care providers, clients, and researchers. Conventional data collection methods for maternal and child health, such as household surveys, may not be suitable to assess processes of service delivery. The electronic maternal and child health registry (MCH eRegistry) has been implemented in 182 governmental primary care clinics in Palestine. Here we present the data in the MCH eRegistry. Methods We processed the raw data in the MCH eRegistry from the West Bank, and documented validation rules for crude data points (time of entry, values allowed). Definitions and appropriate categorisations were created for core process indicators. Data from the MCH eRegistry and the electronic health information system in governmental hospitals were linked using statistical software. Findings As per the second quarter of 2018, the MCH eRegistry contained raw data on 69 793 antenatal care visits, 27 304 postpartum care visits and 40 264 newborn care visits. From antenatal care, data on core process indicators were available for screening of anaemia (n=48 542), hypertension (n=66 814), diabetes (n=18 013), asymptomatic bacteriuria (n=31 757), as well as antenatal ultrasound (n=55 453). Distributions of raw data on haemoglobin and blood pressures had no extreme outliers. Links had been established between antenatal care and delivery data in governmental hospitals for 51% of births. Interpretation The MCH eRegistry contains data from antenatal to postpartum and newborn care. These data have been successfully linked with delivery data, resulting in a large data set on continuity of care and birth outcomes. Furthermore, the data are accessible, of good quality, and can be used for studies of quality of care and maternal and newborn epidemiology, among others. Researchers are invited to use this resource in working towards improving the health system and the health of Palestinians. Funding European Research Council and Research Council of Norway.