Strengthening Immunisation Data Systems: a mixed methods evaluation of the Lao Electronic Immunisation Registry

Strengthening Immunisation Data Systems: a mixed methods evaluation of the Lao Electronic Immunisation Registry | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Article Strengthening Immunisation Data Systems: a mixed methods evaluation of the Lao Electronic Immunisation Registry Cyra Patel, Praveena Gunaratnam, Gemma Saravanos, Mathida Thongseng, and 12 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8664124/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 9 You are reading this latest preprint version Abstract The Lao People's Democratic Republic introduced an electronic immunisation registry (EIR) for routine immunisation in 2022. This study evaluated the EIR during its early stages to inform ongoing implementation and future use. We used a multi-method approach that involved five data sources: document review; health facility survey; key informant interviews; workflow observation; and data quality assessments. We surveyed 26 healthcare workers across 26 facilities. Respondents’ perceptions of the EIR were largely positive, though views on workload were mixed, and most indicated insufficient training and ongoing needs in data analysis and problem-solving. Only half consider infrastructure adequate. Eighteen stakeholder interviews highlighted strong uptake of the EIR and improved ability to generate reports and identify under-immunised children, but also persistent data gaps, limited data use, staff shortages, reliance on development partners, and the need for stronger government ownership, supervision, and a clear long-term roadmap. Data quality assessment of 849,055 non-duplicate vaccination events showed high levels of missing or invalid data and low timeliness of birth and vaccination registration; across four facilities, the EIR captured more doses than paper registers and district reports. This evaluation showed that EIR is feasible and acceptable, but individual and system-level barriers, particularly workforce capacity and capability, digital infrastructure, governance, and financing, must be addressed to realise its impact on vaccination coverage, underscoring the need for future implementation research to optimise EIR use in Lao PDR and similar settings. Health sciences/Health care Health sciences/Medical research Figures Figure 1 Background Electronic immunisation registries (EIRs) are digital systems which capture individual-level vaccination data. They form an integral part of immunisation information systems. 2 They support the secure recording, storage, and sharing of individual and population-level data and can address many problems with traditional paper-based systems for monitoring vaccination and measuring coverage. 2,3 Emerging evidence from low- and middle-income countries (LMICs) suggests that switching from paper-based to paperless recording using EIRs can reduce time per vaccination visit by up to 50%, improve data quality, and effectively underpin health service decision making. 4,5 When integrated into a broader package of immunisation program-strengthening activities, EIRs can support improved vaccine uptake, timeliness of vaccination and coverage, and reduce the number of zero-dose children. 8–13 Evidence on how best to implement and leverage EIRs, particularly in LMICs, is still scarce. EIR implementation requires substantial financial, material and human resource investment. Factors such as insufficient workforce support, increased workload during the transition to electronic systems, infrastructure limitations, poor operational and financial planning and underlying weaknesses in health systems limit effective implementation and uptake. 14–16 The scarcity of comprehensive evaluations and emerging literature on the lessons learned from EIR implementation demonstrates the lack of clarity on how best to implement EIRs. 17,18 This study focuses on the experience of EIR implementation in the Lao People’s Democratic Republic (Lao PDR). Lao PDR is an LMIC in Southeast Asia with an estimated population of 7.6 million people. 19 Childhood vaccinations are provided free of cost at government health facilities and via outreach, yet vaccination coverage remains sub-optimal. Most recent estimates report coverage of DTP1 at 76%, DTP3 at 67%, and MCV1 at 69%. 20,21 Timeliness of vaccination is also poor, with only 62–70% children vaccinated within the recommended 4-week intervals for pentavalent vaccines. 22 Barriers to accessing healthcare, including vaccination services, include geographical remoteness, language, cultural norms, and poor health literacy. 23 Immunisation coverage data in Lao PDR has historically been collected using paper-based systems, specifically daily and monthly tally sheets, with entry of monthly aggregate vaccination doses by type entered into DHIS2 and used to calculate coverage estimates. In 2021, Lao PDR introduced a digital COVID-19 Vaccination Registry. 24 Following this, an EIR for routine childhood immunisation was introduced in 2022- 2023. 24 In this study, we evaluated the EIR during its early stages to inform its ongoing implementation and future use. We aimed to identify facilitators and barriers to EIR implementation, examine stakeholder perspectives on implementation and use of the system, and assess the quality of vaccine data in the EIR. Methods Study setting Lao PDR is administratively divided into 18 provinces and 148 districts, with 62% of the population living in rural areas. 25 Health care delivery is primarily through the public system with four levels of service provision (central, provincial, district and health centres). In 2023 there were five central tertiary referral hospitals, 17 provincial hospitals, 135 district hospitals, and 1,080 health centres. 26 Immunisation services primarily occur at health centres. Vaccinations for children under five years of age are free under the National Immunisation Program. The EIR for routine childhood immunisation was first piloted in a district hospital in the capital city of Vientiane in November 2022 and subsequently rolled out across two provinces (Vientiane Capital and Vientiane Province) between May and August 2023. Nationwide rollout to all 18 provinces occurred in 2024. The Lao EIR uses DHIS2 tracker, which supports the capture of individual-level immunisation data over time, while also allowing aggregation of these data for real-time analysis and visualisation. 27 This evaluation focuses on the initial rollout of the EIR in Vientiane Capital and Vientiane Province. Study design and approach to data collection Our published protocol describes our data collection methods and target participants in detail. 28 Briefly, we used a mixed-methods approach, underpinned by a conceptual model and theory of change that posits that effective implementation of the EIR can improve data use in immunisation program decision-making across the health system, as shown in Figure 1. 28,29 We used a multi-method approach to data collection: 1) document review, to provide the contextual background to inform the design, conduct and interpretation of other study components; 2) health facility surveys, to examine the perspectives of health facility immunisation providers i.e. EIR users; 3) key informant interviews, to examine the perspectives of decision-makers, 4) observation of workflows in health facilities, to verify how immunisation data were entered into the EIR; 5) data quality assessment. Study participants and data sources For the document review, we identified and extracted data from sources relating to the performance and operation of the Lao PDR EIR, the national immunisation program, the health system, or the governance of the health and immunisation systems. We included peer-reviewed publications, grey literature and internal government documents. The health facility survey was conducted at two purposively selected hospital sites in Vientiane Capital and Vientiane Province and randomly selected health facilities in Vientiane Province (target of 50% of the 61 health facilities in Vientiane Province). At each selected health facility, we recruited a health worker involved in immunisation service provision who was also an EIR user. Workflow observations and data quality assessments were conducted at four of the selected health facilities. Data collection for the surveys, workflow observations and data quality assessment was conducted between 8 th to 25 th April 2024. Surveys were conducted in Lao language. For the key informant interviews, we purposively selected stakeholders involved in decision-making about the immunisation program and/or about the EIR, including those involved in its implementation. Invited key informants worked in the health system at the national and subnational levels of government and development partner organisations (including WHO, UNICEF and Gavi The Vaccine Alliance). We aimed to include 12–14 key informants, continuing interviews until saturation was reached. Interviews were conducted in May to June 2024 in Lao or English, depending on the participant’s preference. We obtained vaccination data for the 2023 national birth cohort from the Lao PDR EIR (extracted on 16 August 2024) to assess data quality. Additionally, we obtained data on the number of doses of selected vaccinations (hepatitis B (hepB) registers, DTP-containing vaccine [pentavalent vaccine (penta) dose 1, and measles-containing vaccine (MCV) dose 1) recorded as administered at four health facilities from three data sources (the health facility register, district-level report which uses the DHIS2 aggregate system, and the EIR) over a three-month period (November 2023 to January 2024). Data collection tools For the health facility survey, we developed a cross-sectional survey tool adapted from existing tools (as detailed in our published protocol. 28 The survey captured quantitative and qualitative data across six domains: 1) processes for recording immunisation data, 2) available infrastructure, 3) data management and use, 4) workforce skill and support, 5) satisfaction with the EIR, and 6) perceptions of EIR data quality. The survey was administered by trained data enumerators in Lao language. Survey data was captured using the Research Electronic Data Capture (REDCap) Mobile App system to support offline data collection. At four sites, a data enumerator observed 2–3 vaccination encounters at each site and recorded findings using a site observation tool. The tool included both quantitative and qualitative items. Site observations were completed by a single data enumerator to ensure consistency of the approach. For key informant interviews, we used a semi-structured interview guide informed by previously published literature and protocols provided by content experts. 28 Interview domains included: 1) overall perceived net benefits of the EIR, 2) implementation process of the EIR, 3) impact of the EIR on the national immunisation program, 4) impact of the EIR on decision-making, 5) the cost of implementing the EIR, 6) linkage and inter-operability with other health data systems to support program evaluation, and 7) investment in the EIR. Data Analysis We analysed data separately for each study component, then synthesised the key findings from each component using the study framework to map findings by theme. 31 Findings from the document review were tabulated and narratively summarised across the Pan American Health Organization (PAHO) EIR evaluation tool categories and used to inform the study design and interpretation of findings. Findings from the other study components were compared by theme across the study methods to identify convergent and divergent information. Summary findings for each theme were identified and used to develop recommendations to strengthen the implementation and sustainability of the EIR. For the health facility surveys, we analysed quantitative survey items descriptively, calculating counts and proportions with 95% confidence intervals (based on the Wilson Score Interval method). We used chi-square tests to examine differences in proportions between groups. Analyses were conducted using RStudio (R version 4.4.1, 2024). Qualitative items were summarised narratively. Key informant interviews were transcribed and translated into English. The transcription and translation of the first few interviews were checked by a study team member (NC) fluent in both Lao and English. De-identified English transcripts of the interviews were analysed thematically based on our study framework. Two researchers (AV and CP) initially coded a sample of 25% of interviews based on pre-agreed definitions of themes. Following discussion, adjustments were made to the study framework and theme definitions, with agreement from the study team. One researcher (AV) then coded the remaining interviews. Analyses were conducted using NVivo v.14. Findings were summarised narratively according to the study framework themes, and highlighted the formative benefits of the EIR, stakeholder experiences of implementing the EIR and factors affecting its implementation. For the health facility workflow observations, data were transcribed into a Microsoft Excel spreadsheet for analysis. Findings on the immunisation service characteristics, the processes for recording immunisation data, and the factors influencing data-related workflows were summarised narratively. These findings were used to corroborate the information reported in the health facility surveys. The analysis and findings are summarised in Appendix 1. We analysed EIR data quality based on the dimensions outlined in Table 1. We calculated summary statistics, i.e. counts and proportions, for each quality dimension, and conducted sub-group analysis by sex, location (i.e. province) and service type (particularly fixed versus outreach services) where data were available. Variables were analysed as extracted – we did not interpolate or impute missing data, given the intent was to assess data quality. The unit of analysis was the vaccination encounter (i.e. the clinic visit) for the completeness, timeliness and validity assessment, and the vaccine for the concordance assessment. Ethics approval Ethics approval was obtained from the Lao PDR Ministry of Health Institutional Review Board (National Ethics Committee for Health Research) (submission ID: 2023.71) and the University of Sydney Human Research Committee (protocol 2024/038). All participants were provided with participant information sheets followed by written informed consent. All fieldwork activities were a culturally appropriate and sensitive manner with bilingual local interviewers. Data was collected in Lao or English depending on the participants’ preference. Results Survey We surveyed individual healthcare workers at 26 health facilities, including one provincial hospital, five district hospitals (19.2%) and 20 health centres (76.9%). Table 2 summarises the characteristics of survey participants. The median age of survey participants was 32 years (interquartile range [IQR] 28.0 to 36.3), most were female (22/26, 84.6%) and nurses (16/26, 61.5%). Almost half (12/26, 46.2%) had 5 or more years of experience providing immunisation services. Almost two-thirds self-reported their computer literacy to be either sufficient (15/26, 57.7%) or poor (2/26, 7.7%) rather than good or very good. All 26 participants reported using the EIR, the paper-based health facility register and the child take-home record to record immunisation data. Additional tools used included the health facility tally sheet (24/26, 92.3%), DHIS2 tally sheet (13/26, 50%), and DHIS2 Event Capture (13/26, 50%), noting that the last tool had been phased out at the time of data collection. Participants reported that vaccination data were entered into the EIR before vaccine administration (7/26, 26.9%) or immediately after and before the next patient (14/26, 53.8%). Participants described having specific data management processes at their health facilities, with most reporting that they have processes to obtain data on newborns (23/26, 88.5%), track children overdue for vaccination (25/26, 96.2%), and address errors in the EIR (18/26, 69.2%). Many reported having a regular meeting where immunisation data was discussed (18/26, 69.2%). Survey participants’ perceptions of the EIR were largely positive (Table 3). All found the EIR easy to use and most considered that using the EIR to record immunisation data was faster than using the paper-based system (24/26, 92.3%), however two participants disagreed with this statement. When asked what aspects of the EIR they liked, respondents commented that the EIR made it easier to check individuals’ vaccination status, generate line-listed data of children due for vaccination, and generate summary reports. While all participants said they were satisfied with the overall quality of the EIR data, a few expressed negative perceptions of certain aspects of data quality. Specifically, six (23.1%, 95%CI: 11.0–42.1%) were unsatisfied with the timeliness of data, and two (7.7%, 95%CI: 2.1–24.1%) were unsatisfied with the accuracy of the data. Perceptions on the effect of the EIR on workload were mixed; 13 (50%, 95%CI: 32.1–67.9) perceived that their workload had decreased, while 11 (42.3%, 95%CI: 25.5–61.1) perceived it had increased, and 2 (7.7%, 95%CI: 2.1–24.1) perceived it remained unchanged. The majority indicated that the training they received was insufficient (17/26, 65.4%, 95%CI: 46.2–80.6). Respondents commented that they required refresher training or an extended duration of training, and that more staff needed to be trained, as not everyone could use the EIR. Respondents also highlighted the need for training beyond using the EIR for data collection, expressing that they required training on problem solving, data quality, data analysis, EIR functions and report generation. Table 3 summarises survey findings on the availability and adequacy of the technological infrastructure required to use the EIR. Almost all (24/26, 92.3%, 95%CI: 75.0–97.9%) reported power outages. Four health facilities (15.4%, 95%CI: 6.2–33.5%) did not have internet; of the 22 facilities with internet, more than half experienced occasional (13/22, 59.5%, 95%CI: 38.7–76.7%) or frequent (1/22, 4.5%, 95%CI: 0.8–21.8%) outages. Overall, only half of the respondents (13/26, 50%, 95%CI: 32.1–67.9%) considered the existing infrastructure sufficient to use the EIR. Key informant interviews We interviewed 18 stakeholders (Table 4), including 11 from the provincial hospital, provincial health departments, and the national health department and seven external stakeholders. Most were in their current role for at least 3 years (72%) and had >10 years’ experience in immunisation or maternal and child health (56%). Table 5 details key findings from the key informant interviews, triangulated against findings from other data collection methods. Perspectives on using the EIR Stakeholders considered that the EIR had been positively received by healthcare workers, with good uptake to record immunisation data. They emphasised that the EIR was more convenient than paper and that there was less duplication of recording data. They also noted that generating reports and statistics was now much more streamlined. “It is convenient and advantageous, remembering details from the book was difficult. Now, having the information readily accessible allows us to easily review the vaccinations received by returning patients. Previously, if a patient forgot their logbook, we had no way of knowing their information. Now, with the code, we can add notes to their record. Previously, we had to open the book to determine which unit and village the patient was from, which was difficult. Now, it’s much more convenient” KII1 However, some challenges remain for timely recording as stakeholders noted that multitasking responsibilities (e.g. care provision and recording data) were a barrier to EIR use. “It’s challenging during the outreach because there is only one employee and many patients. Both data entry and administering vaccinations are difficult under these conditions” KII1 Stakeholders considered that EIR had improved the quality of immunisation data recorded compared with paper-based systems. However, they noted that some problems persisted. For example, they discussed that some information was not captured (such as missed doses and overseas vaccinations), and data recording was a challenge in areas without internet. Some noted some of the quality improvement measures in place, such as supportive supervision, site visits, checking data quality at a national level, and discussing provincial performance at national-level meetings to identify areas for improvement. However, they stated that data quality and timeliness could be further improved by implementing clear data quality assurance processes and integrating them into supportive supervision at the health facility level. Stakeholders generally considered that significant effort and progress were made with using the EIR to record immunisation data, but efforts needed to shift towards encouraging effective use of the EIR to improve immunisation service delivery and outcomes. They noted that to some extent this had started to occur, with some citing examples of data use such as using data from the EIR to plan outreach services and travel (e.g. checking if a child had been vaccinated elsewhere), calculating vaccine needs to minimise waste, and identifying unvaccinated children for reporting and follow-up. “We will know exactly what are the number of zero-dose children. We will know exactly what is the number of not fully immunized children. And we will know even these people by ethnic group, by geographic area, by health center. We will be able to say which health center is performing well, which health center is not performing well.” KII11 However, they noted this was not happening regularly yet, and it was too early to observe any meaningful impact. Some respondents also noted the danger in becoming complacent about data use, noting the EIR would not achieve the full scale of its intended benefits if it was not used effectively. “We cannot say that EIR has made any drastic change…What we can say that we have moved one step forward to streamline the data entry and data quality.” KII 12 “I think whether it's the EIR or any system, if we do not use the data and pay attention to it, it becomes merely a tool.” KII17 Perspectives on EIR implementation Stakeholders described the phased implementation of EIR, beginning first with pilot districts and iteratively making improvements before rolling out nationally. They stated that this stepwise approach to EIR implementation was a strength that helped make the EIR more acceptable and manageable, despite the possible trade-off of delaying health benefits from its use. Additionally, the EIR built on the existing DHIS2 aggregate system, so users were familiar with the system. “I think also the existing platform which is DHIS2 was also very good fundament to start. Because still I think the EIR tracker based on DHIS2. If the country didn't have anything, I think it would be even more difficult to implement EIR. But luckily, Lao had this platform before. And they were using this one for a long time. So they had already the capacity and experience.” KII14 Stakeholders discussed the key role of healthcare workers, noting that training and support had facilitated initial EIR implementation, but that workforce capacity and capability barriers remained. They acknowledged that staff shortages and retention were a problem throughout the health system, discussing concerns about high levels of retirement, maternity leave, and the reallocation of staff to other roles. Stakeholders stated that supportive supervision and frequent training would be needed on an ongoing basis (both for new staff and refreshers for existing staff) to improve data quality and use, especially as new functionalities are added to the EIR. Key ongoing needs included continuous capability building in data collection, including workforce training on using data effectively, interrogating data, and using data for decision-making. It was noted that development partner organisations supported the software management for the EIR as well as all analytical work, including data monitoring and coverage analyses, and there was a desire to build this amongst local staff. “This means most of the technical support currently relies on development partners, and the capability of the government staff is still limited” KII19 Stakeholders felt that the success of the EIR in the long-term relied on the government’s ownership of the system and raised concerns that there was a widely held perception that development partners were leading this work. Stakeholders said that partners had played a critical role in both funding and implementing the EIR, but that this had created the impression that EIR implementation was driven by them. The absence of a clear multi-year road map or strategy for the EIR and absence of local financial planning increased this perception. Stakeholders expressed that having a formal plan tied to targets, timelines and finances would strengthen ownership, accountability and leadership by the Ministry of Health. Additionally, they felt that the governance and regulation of the EIR could be strengthened through clear policies and guidelines to support implementation, as well as formal regulations, such as legal frameworks for data security. “Ownership is important…there should be a strong ownership within government with a clear roadmap, sustainability plan, financial analysis, how much they have to pay once the support from partners is matured.” KII12 it's short-term funding, you know, not long-term. And systems like EIR, they need special attention for at least 5-7 years. Based on global learnings, we have seen that it is not possible to, you know, introduce and deploy and then just withdraw support for EIR kind of things. You need to be there for at least 5-7 years. So, if we have a clear roadmap and all those things, then it is easy to, you know, for everyone, for all the stakeholders to contribute.” KII12 “If we want the system to be robust and self-sustaining, the government needs to be more involved. The budget should not solely depend on international sources.” KII7 Another key theme was the desire to improve data culture, including accountability around data collection and use. Stakeholders considered that while there was enthusiasm for the EIR and willingness to improve, but there was a lack of accountability and responsibility. They described a need to foster demand for higher-quality data, better implementation of the EIR, and reduced complacency. The complexity of the system across multiple actors was acknowledged but should not be a barrier to improving data culture. “The responsibility of the staff is crucial. If they do not understand the importance of data, or the reporting process, it’s challenging.” KII18 Stakeholders considered that the digital infrastructure was a substantial constraint to EIR implementation and use, particularly unreliable electricity, limited internet access in some parts of the country, and reliance on development partners for financing internet connectivity. Stakeholders noted the controversial decision to exclude offline data entry functionality from the EIR, as staff from health facilities without internet access would be required to manually enter data at the district-level office, risking delayed data reporting and inaccuracies. Stakeholders also raised concerns about hardware and future replacements, both from a planning and financing perspective. The infrastructural issues led some stakeholders to consider the paper-based system to be necessary for the foreseeable future. “There are two problems with the internet, one, currently the internet is provided by UNICEF, buy a tablet with 12 months of internet data, assuming next year the government has to pay by itself, where will the government raise the budget from? I don't know, there is this limitation; Second, there are still many villages without internet signal, some areas, some health centers have no signal at all, the whole country has 49 health centers without internet, and 40 health centers where the internet signal is not stable. In the whole country, about 10% of the service area do not have internet signal, about 90 health centers.” KII13 “If no electricity, if something will happen, you know, so it's fragile. And paper-based is more resilient. Because paper you can keep in the archive for many, many times.” KII11 Data quality assessment Our analysis included 854,949 vaccination events (i.e. vaccination visits where one or more vaccines were administered), with 849,055 (99.3%) unique non-duplicate vaccination events. Substantial proportion of events had missing data on type of vaccine administered (15.66%, 132,949/849,055), date of vaccination (14.91%, 126,566/849,055) and place of vaccination (15.56%, 132,094/849,055). Of the 849,055 events, 19.44% (n=165,097) had invalid dates, that is, where the date of vaccination was after the date of entry. On timeliness of registration on the EIR, 12.46% and 13.45% of births were registered in the EIR within 3 and 7 days of births (Table 6), and 15.26% and 18.47% of vaccinations were recorded within 3 and 7 days of the date of vaccine administration respectively (Table 6). At the four purposively selected health facilities, the EIR had the highest number of vaccine doses recorded (total n=1026, hepB birth dose n=565, Penta1 n=275, MCV1 n=186) across all three vaccines, followed by the district-level report (total n=967, hepB birth dose n=548, Penta1 n=246, MCV1 n=173), with the fewest doses recorded in the health facility paper-based register (total n=722, hepB birth dose n=415, Penta1 n=179, MCV1 n=128). (Appendix 2). Discussion This study reports findings from a formative evaluation of the Lao EIR, where we report on the implementation of a new digital public health system. We found high levels of acceptance and reported ease of use among frontline health care workers and policymakers. The evaluation also highlighted limitations in current quality and use of data from the EIR, and identified a range of individual and system-level factors that must be addressed for the potential of the system to be realised. These included workforce capacity and capability, data use culture, digital infrastructure, and the availability of clear regulations and standards. This evaluation provides empirical evidence towards the growing literature on the best practices for EIR implementation and use in LMICs. The Lao experience demonstrated that strategic technology choices can accelerate adoption. In our study, the stepwise approach and the use of an existing platform (DHIS2 in this case) as the host for the EIR were emphasised by key informants as crucial to initial success and as important drivers of acceptance and uptake of the system by HCWs. This was due to the preference of both policy makers and users to use existing technological platforms, infrastructure and HCW experience to promote use and to ensure interoperability with existing systems. 1,9 Similar perceptions were found in Rwanda, where initial success and longer-term sustainability of the EIR were attributed to the use of the existing DHIS2 health information system infrastructure. 5 DHIS2 has now been adopted by immunisation systems in over 70 countries worldwide, creating potential for cross-country learning and standardisation. 32 In contrast, other countries, including Tanzania, Vietnam, Guinea, Honduras and Indonesia, have opted for a range of bespoke software applications with varying levels of success. 1,5,33 An iterative process in which the EIR was first piloted before being rolled out nationwide reflects implementation practices in other LMICs and represents emerging best practice in digital health scale-up across diverse health system contexts. 34 The Vietnam EIR experience, commencing in 2010, was characterised by staged deployment of the EIR across provinces before achieving national scale in 2017 with the National Immunization Information System. 1,9 Similarly, in Tanzania and Zambia, implementation commenced in 2014 in both countries, followed by staged deployment over several years to achieve national scale. 1 This convergence of approaches across diverse contexts suggests that phased implementation may be essential rather than optional for sustainable EIR adoption. The delivered training program employed multiple modalities, including in-person training, supportive supervision, technical support, audiovisual materials and guidance documents. This approach reflects the best practice principles of adult learning and was considered by many a strength of implementation. 24,35 However, dissatisfaction is not uncommon and is often attributed to limited access to timely in-person training and retraining. 1,5,16 Health workers in other LMICs have reported similar training gaps, highlighting systemic challenges in adult education approaches to digital health. 36 Cascade training of trainers approaches may address some of these issues while also supporting in-country capacity building and ownership. 1,37 Other effective training strategies may include supportive supervision and mentoring with enhanced engagement for lower-performing areas alongside routine EIR data reviews linked to action planning. 16 These activities are known to improve data quality, data use culture and accountability, and health outcomes in decentralised health systems. 38–40 We found overall high levels of self-reported computer literacy amongst the health workforce, consistent with data reported previously in Lao PDR and elsewhere. 5,37,41 This may have contributed to the observed high levels of acceptance of the EIR. Despite this, system-level factors such as shortages, high turnover, and the workload of health care workers are found to undermine the capacity to implement and use EIRs and health information systems, as other studies have found. 42,43 This pattern underscores that technology success depends less on individual capability than on system-level enablers such as adequate staffing, manageable workloads, and retention strategies. A critical learning was the persistent gap between data collection and data use, a challenge that can undermine the investments in EIR infrastructure. We found an emerging immunisation “data use” culture among health system actors in Lao PDR but specific use of EIR data for decision-making and improving individual vaccine uptake was limited. This finding is unsurprising due to the initial emphasis on establishing foundational EIR data collection, a phenomenon also observed in Vanuatu. 43 Box 1 contains a vignette, drawing on several key informants’ responses, on how they perceived the EIR could be used to proactively track children due or overdue for vaccination and to plan travel and inventory accordingly. The same pattern has emerged in early-stage implementations in countries such as Guinea, Honduras, Rwanda, and Tanzania, suggesting a similar trajectory where data collection precedes data use. 5 As systems and immunisation programs institutionalise the use of EIRs, efforts to incentivise EIR use will need to shift their focus to building individual skills to interpret data, addressing data quality concerns, and establishing processes (e.g., regular data review). Data quality remains a challenge in the early stages of EIR implementation, with implications for global vaccination coverage estimates. In our study, data quality assessment identified several issues, including missing information in vaccination records (>15%), and timeliness of data entry with only 15% of vaccinations recorded within the recommended 3-days post-vaccination. These issues are not uncommon during the early stages of implementation, 44,45 however they highlight the need for ongoing training and supportive supervision, as well as adequate staffing, to ensure healthcare workers safeguard accuracy and completeness of data and coverage estimates over time. 43,46 It also continues to be important to improve civil registration and vital statistics systems and ensure EIR interoperability and implementation of unique identifiers. As registration improves, which appears to be occurring in the Lao PDR, the EIR offers an opportunity to improve target population estimates. Novel methods which use EIR and other data sources to better estimate target populations will be important and represent an opportunity for improving global immunisation coverage estimates, particularly in countries where civil registration systems remain weak. 47 Most importantly, our evaluation in Lao PDR and other settings has demonstrated systemic challenges in translating data into public health action. This should be a key focus as countries, including the Lao PDR, look to expand and enhance EIR use to improve health outcomes. 43 This “last mile” challenge - converting digital data into tangible health improvements through outreach, resource allocation, and program implementation - remains a defining issue for digital health interventions globally. 48 Other health system issues, such as digital infrastructure (e.g. hardware and internet connectivity), are also barriers to EIR implementation. Countries across sub-Saharan Africa and remote areas of Asia and the Pacific face similar infrastructure constraints, including unreliable electricity, limited internet connectivity, and inadequate hardware budgets, which constrain EIR functionality. 49,50 The need for dual data entry across paper and digital systems increases healthcare workers’ workload and potentially decreases efficiency and data accuracy compared to the use of paper or digital systems alone, as previously identified. 5,37 This is contentious, as there is evidence that mixed systems may be more successful in the long term by allowing time for health workers to adjust to the digital system. 51 However, it is generally acknowledged that migration to fully digital systems is needed to realise the full benefits of EIR. 5,51 In Vietnam for example, a readiness assessment of specific provinces identified barriers such as inadequate digital infrastructure in some facilities and supported a staged approach to transitioning to a fully digital system. 5,51 The financing and governance architecture for EIRs carries implications beyond individual countries. Collaboration with external partners was seen as critical to the rollout of the Lao EIR, as reflected in experience in other LMICs. 5 However, as elsewhere, there was a perceived risk of over-reliance on external partners for funding and technical assistance, which could inadvertently undermine in-country priorities, independence, and capacity building. 5 This tension between necessary external support and the imperative for local ownership represents a central paradox of global health implementation, affecting not only EIRs but broader health system strengthening efforts worldwide. 52 Other studies have demonstrated that local governance, led by the Ministry of Health, was critical to sustainability and the consistent use of EIR in accordance with national guidelines. 1 In an illustration of the potential dangers of over-reliance on partner support, phasing out of external support resulted in the discontinuation of the EIR in a third of Tanzanian health facilities due to technical issues that could not be resolved locally, serving as a cautionary tale for countries dependent on external support for their digital health infrastructure. 5 Longer-term sustainability of EIRs in LMICs, including Lao PDR, will ultimately depend on maintenance of digital infrastructure, financial investment and clear governance mechanisms across the government and partner agencies. Understanding the economic implications of digital health interventions is crucial for planning sustainable implementation, as cost assessments can inform budget allocation and identify resource needs for maintaining EIR systems over time. 53 Formal governance mechanisms, such as technical working groups to oversee EIR implementation, enhanced national capacity and a costed and allocated budget, can enable increased local ownership. 1 A strength of our study is its mixed-methods approach, which utilises established methods alongside pragmatic and innovative approaches to evaluate implementation, drawing on diverse indicators relating to workforce experience, data use, data quality, digital infrastructure, and governance. As a result, the evaluation highlights how these distinct system elements interact to enable or constrain EIR implementation and its potential to improve vaccination coverage. An important limitation of this evaluation arises from the lack of standardised indicators to measure EIR use and the capacity to collect and analyse data on costs associated with EIR implementation. Both are important areas for future research. The absence of standardised metrics hampers cross-country learning and represents a gap in the global digital health evidence base. 54 Other limitations include potential bias in facility and participant selection, as well as response bias. Due to the stage of Lao EIR implementation, as well as time and resource constraints, data collection was undertaken in 2 of 18 provinces, including the national capital, so responses may not be representative of other areas in Lao PDR, which may face more pronounced challenges with respect to rurality, internet connectivity and health workforce shortages. The overall positive perceptions of the EIR found in our study may have been influenced by response desirability bias. Additionally, age is a recognised influencer of digital capability, and the young age of our survey sample may be influenced by this. 55 Lastly, consumer and community perceptions of the EIR were not explored in this study but are an increasingly important consideration in enhancing the ‘people-centred’ focus of healthcare alongside the growing presence of individual electronic health records. 47,56 Conclusion This is among the first studies to evaluate early implementation of an EIR in a LMIC setting. We demonstrated high levels of feasibility and acceptability, but that numerous individual and system-level barriers, including workforce capacity and capability, digital infrastructure, governance and financing, must be addressed in achieving and sustaining any potential impact of the EIR on vaccination coverage. Future studies should include implementation research to test strategies utilising EIRs in Lao PDR and similar settings to increase and sustain vaccination coverage, including among currently un- and under-immunised populations. Declarations Acknowledgements We would like to thank Dr Jessica Hall and Ms Michelle Lynch for their contributions to project management and protocol development, and Ms Kanika Madan for supporting the data quality analysis. We thank Dr Amphone Keooudom, Dr Somphathai Bouathong, Mr Khamphet Luanglath, Mr Somkhit Bouavong, Ms Boualien Phon-Asa, and Mr Khamvieng Phommachanh for their support in data collection. We also thank the Lao PDR Ministry of Health for accompanying the study team during data collection and for their overall support for the project. We would also like to thank Gavi, the Vaccine Alliance and the Government of Japan for providing financial support for the implementation of the EIR in Lao PDR. Authors’ contributions MS conceptualised and supervised the study. MS, CP and GS designed the study with input from all authors. GS, MT, NC and MS collected the data. CP, GS, AV and AT analysed the data, with all authors involved in interpretation. CP, GS, PG and MS drafted the paper. All authors critically reviewed and provided input and approved the final version of the paper. Conflicts of interests None to declare. Funding The project was funded from the Australian Government Department of Foreign Affairs and Trade Australian Expert Technical Assistance Program for Regional COVID-19 Vaccine Access: Policy, Planning and Implementation (AETAP-PPI) to the Australian Regional Immunisation Alliance (ARIA) (GID 212641) References Carnahan E, Nguyen L, Dao S, Bwakya M, Mtenga H, Duong H, et al. Design, development, and deployment of an electronic immunization registry: experiences from Vietnam, Tanzania, and Zambia. Glob Health Sci Pract. 2023 Feb 28;11(1):e2100804. 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Balzarini F, Frascella B, Oradini-Alacreu A, Gaetti G, Lopalco PL, Edelstein M, et al. Does the use of personal electronic health records increase vaccine uptake? A systematic review. Vaccine. 2020 Aug 27;38(38):5966–78. Tables Tables 1 to 6 are available in the Supplementary Files section. Box 1 Box 1 is available in the Supplementary Files section. Additional Declarations No competing interests reported. Supplementary Files Appendix1siteobservationfindings1.docx Appendix2dataconcordanceresults1.docx Tables.docx Box1.docx Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Revision requested 09 Mar, 2026 Reviews received at journal 06 Mar, 2026 Reviewers agreed at journal 25 Feb, 2026 Reviews received at journal 25 Feb, 2026 Reviewers agreed at journal 04 Feb, 2026 Reviewers invited by journal 30 Jan, 2026 Editor assigned by journal 29 Jan, 2026 Submission checks completed at journal 29 Jan, 2026 First submitted to journal 21 Jan, 2026 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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10:04:44","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":715289,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8664124/v1/9416128e-c59f-44ad-9543-e58d3ab9ab06.pdf"},{"id":101881361,"identity":"531de83a-8e80-4506-bef8-3af1043cfe78","added_by":"auto","created_at":"2026-02-04 15:11:44","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":29192,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix1siteobservationfindings1.docx","url":"https://assets-eu.researchsquare.com/files/rs-8664124/v1/4503a60c834ea45b34e932e4.docx"},{"id":101789318,"identity":"869897e1-09d2-45c9-a5f3-03a4f5749755","added_by":"auto","created_at":"2026-02-03 15:57:13","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":91314,"visible":true,"origin":"","legend":"","description":"","filename":"Appendix2dataconcordanceresults1.docx","url":"https://assets-eu.researchsquare.com/files/rs-8664124/v1/473886c801fbe6b0ef6cc64d.docx"},{"id":101789321,"identity":"090d63fe-f93b-4c03-a196-e2953822f260","added_by":"auto","created_at":"2026-02-03 15:57:13","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":46596,"visible":true,"origin":"","legend":"","description":"","filename":"Tables.docx","url":"https://assets-eu.researchsquare.com/files/rs-8664124/v1/31e76109975aaefbec95274c.docx"},{"id":101881338,"identity":"15d3cacc-06a3-4d59-b651-61cb6a1e6b44","added_by":"auto","created_at":"2026-02-04 15:11:36","extension":"docx","order_by":4,"title":"","display":"","copyAsset":false,"role":"supplement","size":14672,"visible":true,"origin":"","legend":"","description":"","filename":"Box1.docx","url":"https://assets-eu.researchsquare.com/files/rs-8664124/v1/525fe80f79af2adcf4450425.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Strengthening Immunisation Data Systems: a mixed methods evaluation of the Lao Electronic Immunisation Registry","fulltext":[{"header":"Background","content":"\u003cp\u003eElectronic immunisation registries (EIRs) are digital systems which capture individual-level vaccination data. They form an integral part of immunisation information systems.\u003csup\u003e2\u003c/sup\u003e They support the secure recording, storage, and sharing of individual and population-level data and can address many problems with traditional paper-based systems for monitoring vaccination and measuring coverage.\u003csup\u003e2,3\u003c/sup\u003e Emerging evidence from low- and middle-income countries (LMICs) suggests that switching from paper-based to paperless recording using EIRs can reduce time per vaccination visit by up to 50%, improve data quality, and effectively underpin health service decision making.\u003csup\u003e4,5\u003c/sup\u003e\u0026nbsp; When integrated into a broader package of immunisation program-strengthening activities, EIRs can support improved vaccine uptake, timeliness of vaccination and coverage, and reduce the number of zero-dose children.\u003csup\u003e8\u0026ndash;13\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eEvidence on how best to implement and leverage EIRs, particularly in LMICs, is still scarce. EIR implementation requires substantial financial, material and human resource investment. Factors such as insufficient workforce support, increased workload during the transition to electronic systems, infrastructure limitations, poor operational and financial planning and underlying weaknesses in health systems limit effective implementation and uptake.\u003csup\u003e14\u0026ndash;16\u003c/sup\u003e The scarcity of comprehensive evaluations and emerging literature on the lessons learned from EIR implementation demonstrates the lack of clarity on how best to implement EIRs.\u003csup\u003e17,18\u003c/sup\u003e This study focuses on the experience of EIR implementation in the Lao People\u0026rsquo;s Democratic Republic (Lao PDR).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eLao PDR is an LMIC in Southeast Asia with an estimated population of 7.6 million people.\u003csup\u003e19\u003c/sup\u003e Childhood vaccinations are provided free of cost at government health facilities and via outreach, yet vaccination coverage remains sub-optimal. Most recent estimates report coverage of DTP1 at 76%, DTP3 at 67%, and MCV1 at 69%.\u003csup\u003e20,21\u003c/sup\u003e Timeliness of vaccination is also poor, with only 62\u0026ndash;70% children vaccinated within the recommended 4-week intervals for pentavalent vaccines.\u003csup\u003e22\u003c/sup\u003e Barriers to accessing healthcare, including vaccination services, include geographical remoteness, language, cultural norms, and poor health literacy.\u003csup\u003e23\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eImmunisation coverage data in Lao PDR\u0026nbsp;has historically been collected using paper-based systems, specifically daily and monthly tally sheets,\u0026nbsp;with entry of monthly aggregate vaccination doses by type entered into DHIS2 and used to calculate coverage estimates.\u0026nbsp;In 2021, Lao PDR introduced a digital COVID-19 Vaccination Registry.\u003csup\u003e24\u003c/sup\u003e Following this, an EIR for routine childhood immunisation was introduced in 2022- 2023.\u003csup\u003e24\u003c/sup\u003e In this study, we evaluated the EIR during its early stages to inform its ongoing implementation and future use. We aimed to identify facilitators and barriers to EIR implementation, examine stakeholder perspectives on implementation and use of the system, and assess the quality of vaccine data in the EIR.\u0026nbsp;\u003c/p\u003e"},{"header":" Methods","content":"\u003ch2\u003eStudy setting\u003c/h2\u003e\n\u003cp\u003eLao PDR is administratively divided into 18 provinces and 148 districts, with 62% of the population living in rural areas.\u003csup\u003e25\u003c/sup\u003e Health care delivery is primarily through the public system with four levels of service provision (central, provincial, district and health centres). In 2023 there were five central tertiary referral hospitals, 17 provincial hospitals, 135 district hospitals, and 1,080 health centres.\u003csup\u003e26\u003c/sup\u003e Immunisation services primarily occur at health centres. Vaccinations for children under five years of age are free under the National Immunisation Program. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe EIR for routine childhood immunisation was first piloted in\u0026nbsp;a district hospital in the capital city of Vientiane in November 2022 and subsequently rolled out across two provinces (Vientiane Capital and Vientiane Province)\u0026nbsp;between May and August 2023. Nationwide rollout to all 18 provinces occurred in 2024. The Lao EIR uses DHIS2 tracker, which supports the capture of individual-level immunisation data over time, while also allowing aggregation of these data for real-time analysis and visualisation.\u003csup\u003e27\u003c/sup\u003e This evaluation focuses on the initial rollout of the EIR in Vientiane Capital and Vientiane Province.\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eStudy design and approach to data collection\u0026nbsp;\u003c/h2\u003e\n\u003cp\u003eOur published protocol describes our data collection methods and target participants in detail.\u003csup\u003e28\u003c/sup\u003e Briefly, we used a mixed-methods approach, underpinned by a conceptual model and theory of change that posits that effective implementation of the EIR can improve data use in immunisation program decision-making across the health system, as shown in Figure 1.\u003csup\u003e28,29\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe used a multi-method approach to data collection:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e1) document review, to provide the contextual background to inform the design, conduct and interpretation of other study components;\u003c/p\u003e\n\u003cp\u003e2) health facility surveys, to examine the perspectives of health facility immunisation providers i.e. EIR users;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e3) key informant interviews, to examine the perspectives of decision-makers,\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e4) observation of workflows in health facilities, to verify how immunisation data were entered into the EIR;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e5) data quality assessment.\u003c/p\u003e\n\u003ch2\u003eStudy participants and data sources\u003c/h2\u003e\n\u003cp\u003eFor the document review, we identified and extracted data from sources relating to the performance and operation of the Lao PDR EIR, the national immunisation program, the health system, or the governance of the health and immunisation systems. We included peer-reviewed publications, grey literature and internal government documents.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe health facility survey was conducted at two purposively selected hospital sites in Vientiane Capital and Vientiane Province and randomly selected health facilities in Vientiane Province (target of 50% of the 61 health facilities in Vientiane Province). At each selected health facility, we recruited a health worker involved in immunisation service provision who was also an EIR user. Workflow observations and data quality assessments were conducted at four of the selected health facilities. Data collection for the surveys, workflow observations and data quality assessment was conducted between 8\u003csup\u003eth\u003c/sup\u003e to 25\u003csup\u003eth\u003c/sup\u003e April 2024. Surveys were conducted in Lao language.\u003c/p\u003e\n\u003cp\u003eFor the key informant interviews, we purposively selected stakeholders involved in decision-making about the immunisation program and/or about the EIR, including those involved in its implementation. Invited key informants worked in the health system at the national and subnational levels of government and development partner organisations (including WHO, UNICEF and Gavi The Vaccine Alliance). We aimed to include 12\u0026ndash;14 key informants, continuing interviews until saturation was reached. Interviews were conducted in May to June 2024 in Lao or English, depending on the participant\u0026rsquo;s preference.\u003c/p\u003e\n\u003cp\u003eWe obtained vaccination data for the 2023 national birth cohort from the Lao PDR EIR (extracted on 16 August 2024) to assess data quality. Additionally, we obtained data on the number of doses of selected vaccinations (hepatitis B (hepB) registers, DTP-containing vaccine [pentavalent vaccine (penta) dose 1, and measles-containing vaccine (MCV) dose 1) recorded as administered at four health facilities from three data sources (the health facility register, district-level report which uses the DHIS2 aggregate system, and the EIR) over a three-month period (November 2023 to January 2024).\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eData collection tools\u003c/h2\u003e\n\u003cp\u003eFor the health facility survey, we developed a cross-sectional survey tool adapted from existing tools (as detailed in our published protocol.\u003csup\u003e28\u003c/sup\u003e The survey captured quantitative and qualitative data across six domains: 1) processes for recording immunisation data, 2) available infrastructure, 3) data management and use, 4) workforce skill and support, 5) satisfaction with the EIR, and 6) perceptions of EIR data quality. The survey was administered by trained data enumerators in Lao language. Survey data was captured using the Research Electronic Data Capture (REDCap) Mobile App system to support offline data collection. At four sites, a data enumerator observed 2\u0026ndash;3 vaccination encounters at each site and recorded findings using a site observation tool. The tool included both quantitative and qualitative items. Site observations were completed by a single data enumerator to ensure consistency of the approach.\u003c/p\u003e\n\u003cp\u003eFor key informant interviews, we used a semi-structured interview guide informed by previously published literature and protocols provided by content experts.\u003csup\u003e28\u003c/sup\u003e Interview domains included: 1) overall perceived net benefits of the EIR, 2) implementation process of the EIR, 3) impact of the EIR on the national immunisation program, 4) impact of the EIR on decision-making, 5) the cost of implementing the EIR, 6) linkage and inter-operability with other health data systems to support program evaluation, and 7) investment in the EIR.\u0026nbsp;\u003c/p\u003e\n\u003ch2\u003eData Analysis\u003c/h2\u003e\n\u003cp\u003eWe analysed data separately for each study component, then synthesised the key findings from each component using the study framework to map findings by theme.\u003csup\u003e31\u003c/sup\u003e Findings from the document review were tabulated and narratively summarised across the Pan American Health Organization (PAHO) EIR evaluation tool categories and used to inform the study design and interpretation of findings. Findings from the other study components were compared by theme across the study methods to identify convergent and divergent information. Summary findings for each theme were identified and used to develop recommendations to strengthen the implementation and sustainability of the EIR.\u003c/p\u003e\n\u003cp\u003eFor the health facility surveys, we analysed quantitative survey items descriptively, calculating counts and proportions with 95% confidence intervals (based on the Wilson Score Interval method). We used chi-square tests to examine differences in proportions between groups. Analyses were conducted using RStudio (R version 4.4.1, 2024). Qualitative items were summarised narratively.\u003c/p\u003e\n\u003cp\u003eKey informant interviews were transcribed and translated into English. The transcription and translation of the first few interviews were checked by a study team member (NC) fluent in both Lao and English. De-identified English transcripts of the interviews were analysed thematically based on our study framework. Two researchers (AV and CP) initially coded a sample of 25% of interviews based on pre-agreed definitions of themes. Following discussion, adjustments were made to the study framework and theme definitions, with agreement from the study team. One researcher (AV) then coded the remaining interviews. Analyses were conducted using NVivo v.14. Findings were summarised narratively according to the study framework themes, and highlighted the formative benefits of the EIR, stakeholder experiences of implementing the EIR and factors affecting its implementation.\u003c/p\u003e\n\u003cp\u003eFor the health facility workflow observations, data were transcribed into a Microsoft Excel spreadsheet for analysis. Findings on the immunisation service characteristics, the processes for recording immunisation data, and the factors influencing data-related workflows were summarised narratively. These findings were used to corroborate the information reported in the health facility surveys. The analysis and findings are summarised in Appendix 1.\u003c/p\u003e\n\u003cp\u003eWe analysed EIR data quality based on the dimensions outlined in Table 1. We calculated summary statistics, i.e. counts and proportions, for each quality dimension, and conducted sub-group analysis by sex, location (i.e. province) and service type (particularly fixed versus outreach services) where data were available. Variables were analysed as extracted \u0026ndash; we did not interpolate or impute missing data, given the intent was to assess data quality. The unit of analysis was the vaccination encounter (i.e. the clinic visit) for the completeness, timeliness and validity assessment, and the vaccine for the concordance assessment.\u0026nbsp;\u003c/p\u003e\n\u003ch1\u003eEthics approval\u0026nbsp;\u003c/h1\u003e\n\u003cp\u003eEthics approval was obtained from the Lao PDR Ministry of Health Institutional Review Board (National Ethics Committee for Health Research) (submission ID: 2023.71) and the University of Sydney Human Research Committee (protocol 2024/038). All participants were provided with participant information sheets followed by written informed consent. All fieldwork activities were a culturally appropriate and sensitive manner with bilingual local interviewers. Data was collected in Lao or English depending on the participants\u0026rsquo; preference.\u003c/p\u003e"},{"header":"Results","content":"\u003ch2\u003eSurvey \u003c/h2\u003e\n\u003cp\u003eWe surveyed individual healthcare workers at 26 health facilities, including one provincial hospital, five district hospitals (19.2%) and 20 health centres (76.9%). Table 2 summarises the characteristics of survey participants. The median age of survey participants was 32 years (interquartile range [IQR] 28.0 to 36.3), most were female (22/26, 84.6%) and nurses (16/26, 61.5%). Almost half (12/26, 46.2%) had 5 or more years of experience providing immunisation services. Almost two-thirds self-reported their computer literacy to be either sufficient (15/26, 57.7%) or poor (2/26, 7.7%) rather than good or very good.\u003c/p\u003e\n\u003cp\u003eAll 26 participants reported using the EIR, the paper-based health facility register and the child take-home record to record immunisation data. Additional tools used included the health facility tally sheet (24/26, 92.3%), DHIS2 tally sheet (13/26, 50%), and DHIS2 Event Capture (13/26, 50%), noting that the last tool had been phased out at the time of data collection. Participants reported that vaccination data were entered into the EIR before vaccine administration (7/26, 26.9%) or immediately after and before the next patient (14/26, 53.8%). Participants described having specific data management processes at their health facilities, with most reporting that they have processes to obtain data on newborns (23/26, 88.5%), track children overdue for vaccination (25/26, 96.2%), and address errors in the EIR (18/26, 69.2%). Many reported having a regular meeting where immunisation data was discussed (18/26, 69.2%).\u003c/p\u003e\n\u003cp\u003eSurvey participants\u0026rsquo; perceptions of the EIR were largely positive (Table 3). All found the EIR easy to use and most considered that using the EIR to record immunisation data was faster than using the paper-based system (24/26, 92.3%), however two participants disagreed with this statement. When asked what aspects of the EIR they liked, respondents commented that the EIR made it easier to check individuals\u0026rsquo; vaccination status, generate line-listed data of children due for vaccination, and generate summary reports. While all participants said they were satisfied with the overall quality of the EIR data, a few expressed negative perceptions of certain aspects of data quality. Specifically, six (23.1%, 95%CI: 11.0\u0026ndash;42.1%) were unsatisfied with the timeliness of data, and two (7.7%, 95%CI: 2.1\u0026ndash;24.1%) were unsatisfied with the accuracy of the data. \u003c/p\u003e\n\u003cp\u003ePerceptions on the effect of the EIR on workload were mixed; 13 (50%, 95%CI: 32.1\u0026ndash;67.9) perceived that their workload had decreased, while 11 (42.3%, 95%CI: 25.5\u0026ndash;61.1) perceived it had increased, and 2 (7.7%, 95%CI: 2.1\u0026ndash;24.1) perceived it remained unchanged. The majority indicated that the training they received was insufficient (17/26, 65.4%, 95%CI: 46.2\u0026ndash;80.6). Respondents commented that they required refresher training or an extended duration of training, and that more staff needed to be trained, as not everyone could use the EIR. Respondents also highlighted the need for training beyond using the EIR for data collection, expressing that they required training on problem solving, data quality, data analysis, EIR functions and report generation. \u003c/p\u003e\n\u003cp\u003eTable 3 summarises survey findings on the availability and adequacy of the technological infrastructure required to use the EIR. Almost all (24/26, 92.3%, 95%CI: 75.0\u0026ndash;97.9%) reported power outages. Four health facilities (15.4%, 95%CI: 6.2\u0026ndash;33.5%) did not have internet; of the 22 facilities with internet, more than half experienced occasional (13/22, 59.5%, 95%CI: 38.7\u0026ndash;76.7%) or frequent (1/22, 4.5%, 95%CI: 0.8\u0026ndash;21.8%) outages. Overall, only half of the respondents (13/26, 50%, 95%CI: 32.1\u0026ndash;67.9%) considered the existing infrastructure sufficient to use the EIR. \u003c/p\u003e\n\u003ch2\u003eKey informant interviews\u003c/h2\u003e\n\u003cp\u003eWe interviewed 18 stakeholders (Table 4), including 11 from the provincial hospital, provincial health departments, and the national health department and seven external stakeholders. Most were in their current role for at least 3 years (72%) and had \u0026gt;10 years\u0026rsquo; experience in immunisation or maternal and child health (56%). \u003c/p\u003e\n\u003cp\u003eTable 5 details key findings from the key informant interviews, triangulated against findings from other data collection methods.\u003c/p\u003e\n\u003cp\u003e\u003cu\u003ePerspectives on using the EIR\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eStakeholders considered that the EIR had been positively received by healthcare workers, with good uptake to record immunisation data. They emphasised that the EIR was more convenient than paper and that there was less duplication of recording data. They also noted that generating reports and statistics was now much more streamlined. \u003c/p\u003e\n\u003cp\u003e\u0026ldquo;It is convenient and advantageous, remembering details from the book was difficult. Now, having the information readily accessible allows us to easily review the vaccinations received by returning patients. Previously, if a patient forgot their logbook, we had no way of knowing their information. Now, with the code, we can add notes to their record. Previously, we had to open the book to determine which unit and village the patient was from, which was difficult. Now, it\u0026rsquo;s much more convenient\u0026rdquo; KII1\u003c/p\u003e\n\u003cp\u003eHowever, some challenges remain for timely recording as stakeholders noted that multitasking responsibilities (e.g. care provision and recording data) were a barrier to EIR use.\u003c/p\u003e\n\u003cp\u003e\u0026ldquo;It\u0026rsquo;s challenging during the outreach because there is only one employee and many patients. Both data entry and administering vaccinations are difficult under these conditions\u0026rdquo; KII1\u003c/p\u003e\n\u003cp\u003eStakeholders considered that EIR had improved the quality of immunisation data recorded compared with paper-based systems. However, they noted that some problems persisted. For example, they discussed that some information was not captured (such as missed doses and overseas vaccinations), and data recording was a challenge in areas without internet. Some noted some of the quality improvement measures in place, such as supportive supervision, site visits, checking data quality at a national level, and discussing provincial performance at national-level meetings to identify areas for improvement. However, they stated that data quality and timeliness could be further improved by implementing clear data quality assurance processes and integrating them into supportive supervision at the health facility level.\u003c/p\u003e\n\u003cp\u003eStakeholders generally considered that significant effort and progress were made with using the EIR to record immunisation data, but efforts needed to shift towards encouraging effective use of the EIR to improve immunisation service delivery and outcomes. They noted that to some extent this had started to occur, with some citing examples of data use such as using data from the EIR to plan outreach services and travel (e.g. checking if a child had been vaccinated elsewhere), calculating vaccine needs to minimise waste, and identifying unvaccinated children for reporting and follow-up. \u003c/p\u003e\n\u003cp\u003e\u0026ldquo;We will know exactly what are the number of zero-dose children. We will know exactly what is the number of not fully immunized children. And we will know even these people by ethnic group, by geographic area, by health center. We will be able to say which health center is performing well, which health center is not performing well.\u0026rdquo; KII11\u003c/p\u003e\n\u003cp\u003eHowever, they noted this was not happening regularly yet, and it was too early to observe any meaningful impact. Some respondents also noted the danger in becoming complacent about data use, noting the EIR would not achieve the full scale of its intended benefits if it was not used effectively. \u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u0026ldquo;We cannot say that EIR has made any drastic change\u0026hellip;What we can say that we have moved one step forward to streamline the data entry and data quality.\u0026rdquo; KII 12\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u0026ldquo;I think whether it\u0026apos;s the EIR or any system, if we do not use the data and pay attention to it, it becomes merely a tool.\u0026rdquo; KII17\u003c/p\u003e\n\u003cp\u003e\u003cu\u003ePerspectives on EIR implementation\u003c/u\u003e\u003c/p\u003e\n\u003cp\u003eStakeholders described the phased implementation of EIR, beginning first with pilot districts and iteratively making improvements before rolling out nationally. They stated that this stepwise approach to EIR implementation was a strength that helped make the EIR more acceptable and manageable, despite the possible trade-off of delaying health benefits from its use. Additionally, the EIR built on the existing DHIS2 aggregate system, so users were familiar with the system. \u003c/p\u003e\n\u003cp\u003e\u0026ldquo;I think also the existing platform which is DHIS2 was also very good fundament to start. Because still I think the EIR tracker based on DHIS2. If the country didn\u0026apos;t have anything, I think it would be even more difficult to implement EIR. But luckily, Lao had this platform before. And they were using this one for a long time. So they had already the capacity and experience.\u0026rdquo; KII14\u003c/p\u003e\n\u003cp\u003eStakeholders discussed the key role of healthcare workers, noting that training and support had facilitated initial EIR implementation, but that workforce capacity and capability barriers remained. They acknowledged that staff shortages and retention were a problem throughout the health system, discussing concerns about high levels of retirement, maternity leave, and the reallocation of staff to other roles. Stakeholders stated that supportive supervision and frequent training would be needed on an ongoing basis (both for new staff and refreshers for existing staff) to improve data quality and use, especially as new functionalities are added to the EIR. Key ongoing needs included continuous capability building in data collection, including workforce training on using data effectively, interrogating data, and using data for decision-making. It was noted that development partner organisations supported the software management for the EIR as well as all analytical work, including data monitoring and coverage analyses, and there was a desire to build this amongst local staff. \u003c/p\u003e\n\u003cp\u003e\u0026ldquo;This means most of the technical support currently relies on development partners, and the capability of the government staff is still limited\u0026rdquo; KII19\u003c/p\u003e\n\u003cp\u003eStakeholders felt that the success of the EIR in the long-term relied on the government\u0026rsquo;s ownership of the system and raised concerns that there was a widely held perception that development partners were leading this work. Stakeholders said that partners had played a critical role in both funding and implementing the EIR, but that this had created the impression that EIR implementation was driven by them. The absence of a clear multi-year road map or strategy for the EIR and absence of local financial planning increased this perception. Stakeholders expressed that having a formal plan tied to targets, timelines and finances would strengthen ownership, accountability and leadership by the Ministry of Health. Additionally, they felt that the governance and regulation of the EIR could be strengthened through clear policies and guidelines to support implementation, as well as formal regulations, such as legal frameworks for data security.\u003c/p\u003e\n\u003cp\u003e\u0026ldquo;Ownership is important\u0026hellip;there should be a strong ownership within government with a clear roadmap, sustainability plan, financial analysis, how much they have to pay once the support from partners is matured.\u0026rdquo; KII12\u003c/p\u003e\n\u003cp\u003eit\u0026apos;s short-term funding, you know, not long-term. And systems like EIR, they need special attention for at least 5-7 years. Based on global learnings, we have seen that it is not possible to, you know, introduce and deploy and then just withdraw support for EIR kind of things. You need to be there for at least 5-7 years. So, if we have a clear roadmap and all those things, then it is easy to, you know, for everyone, for all the stakeholders to contribute.\u0026rdquo; KII12 \u003c/p\u003e\n\u003cp\u003e\u0026ldquo;If we want the system to be robust and self-sustaining, the government needs to be more involved. The budget should not solely depend on international sources.\u0026rdquo; KII7\u003c/p\u003e\n\u003cp\u003eAnother key theme was the desire to improve data culture, including accountability around data collection and use. Stakeholders considered that while there was enthusiasm for the EIR and willingness to improve, but there was a lack of accountability and responsibility. They described a need to foster demand for higher-quality data, better implementation of the EIR, and reduced complacency. The complexity of the system across multiple actors was acknowledged but should not be a barrier to improving data culture.\u003c/p\u003e\n\u003cp\u003e\u0026ldquo;The responsibility of the staff is crucial. If they do not understand the importance of data, or the reporting process, it\u0026rsquo;s challenging.\u0026rdquo; KII18\u003c/p\u003e\n\u003cp\u003eStakeholders considered that the digital infrastructure was a substantial constraint to EIR implementation and use, particularly unreliable electricity, limited internet access in some parts of the country, and reliance on development partners for financing internet connectivity. Stakeholders noted the controversial decision to exclude offline data entry functionality from the EIR, as staff from health facilities without internet access would be required to manually enter data at the district-level office, risking delayed data reporting and inaccuracies. Stakeholders also raised concerns about hardware and future replacements, both from a planning and financing perspective. The infrastructural issues led some stakeholders to consider the paper-based system to be necessary for the foreseeable future.\u003c/p\u003e\n\u003cp\u003e\u0026ldquo;There are two problems with the internet, one, currently the internet is provided by UNICEF, buy a tablet with 12 months of internet data, assuming next year the government has to pay by itself, where will the government raise the budget from? I don\u0026apos;t know, there is this limitation; Second, there are still many villages without internet signal, some areas, some health centers have no signal at all, the whole country has 49 health centers without internet, and 40 health centers where the internet signal is not stable. In the whole country, about 10% of the service area do not have internet signal, about 90 health centers.\u0026rdquo; KII13\u003c/p\u003e\n\u003cp\u003e\u0026ldquo;If no electricity, if something will happen, you know, so it\u0026apos;s fragile. And paper-based is more resilient. Because paper you can keep in the archive for many, many times.\u0026rdquo; KII11\u003c/p\u003e\n\u003ch2\u003eData quality assessment\u003c/h2\u003e\n\u003cp\u003eOur analysis included 854,949 vaccination events (i.e. vaccination visits where one or more vaccines were administered), with 849,055 (99.3%) unique non-duplicate vaccination events. Substantial proportion of events had missing data on type of vaccine administered (15.66%, 132,949/849,055), date of vaccination (14.91%, 126,566/849,055) and place of vaccination (15.56%, 132,094/849,055). Of the 849,055 events, 19.44% (n=165,097) had invalid dates, that is, where the date of vaccination was after the date of entry. On timeliness of registration on the EIR, 12.46% and 13.45% of births were registered in the EIR within 3 and 7 days of births (Table 6), and 15.26% and 18.47% of vaccinations were recorded within 3 and 7 days of the date of vaccine administration respectively (Table 6). \u003c/p\u003e\n\u003cp\u003eAt the four purposively selected health facilities, the EIR had the highest number of vaccine doses recorded (total n=1026, hepB birth dose n=565, Penta1 n=275, MCV1 n=186) across all three vaccines, followed by the district-level report (total n=967, hepB birth dose n=548, Penta1 n=246, MCV1 n=173), with the fewest doses recorded in the health facility paper-based register (total n=722, hepB birth dose n=415, Penta1 n=179, MCV1 n=128). (Appendix 2).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study reports findings from a formative evaluation of the Lao EIR, where we report on the implementation of a new digital public health system. We found high levels of acceptance and reported ease of use among frontline health care workers and policymakers. The evaluation also highlighted limitations in current quality and use of data from the EIR, and identified a range of individual and system-level factors that must be addressed for the potential of the system to be realised. These included workforce capacity and capability, data use culture, digital infrastructure, and the availability of clear regulations and standards. This evaluation provides empirical evidence towards the growing literature on the best practices for EIR implementation and use in LMICs.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe Lao experience demonstrated that strategic technology choices can accelerate adoption. In our study, the stepwise approach and the use of an existing platform (DHIS2 in this case) as the host for the EIR were emphasised by key informants as crucial to initial success and as important drivers of acceptance and uptake of the system by HCWs. This was due to the preference of both policy makers and users to use existing technological platforms, infrastructure and HCW experience to promote use and to ensure interoperability with existing systems.\u003csup\u003e1,9\u003c/sup\u003e Similar perceptions were found in Rwanda, where initial success and longer-term sustainability of the EIR were attributed to the use of the existing DHIS2 health information system infrastructure.\u003csup\u003e5\u003c/sup\u003e DHIS2 has now been adopted by immunisation systems in over 70 countries worldwide, creating potential for cross-country learning and standardisation.\u003csup\u003e32\u003c/sup\u003e In contrast, other countries, including Tanzania, Vietnam, Guinea, Honduras and Indonesia, have opted for a range of bespoke software applications with varying levels of success.\u003csup\u003e1,5,33\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAn iterative process in which the EIR was first piloted before being rolled out nationwide reflects implementation practices in other LMICs and represents emerging best practice in digital health scale-up across diverse health system contexts.\u003csup\u003e34\u003c/sup\u003e The Vietnam EIR experience, commencing in 2010, was characterised by staged deployment of the EIR across provinces before achieving national scale in 2017 with the National Immunization Information System.\u003csup\u003e1,9\u003c/sup\u003e Similarly, in Tanzania and Zambia, implementation commenced in 2014 in both countries, followed by staged deployment over several years to achieve national scale.\u003csup\u003e1\u003c/sup\u003eThis convergence of approaches across diverse contexts suggests that phased implementation may be essential rather than optional for sustainable EIR adoption.\u003c/p\u003e\n\u003cp\u003eThe delivered training program employed multiple modalities, including in-person training, supportive supervision, technical support, audiovisual materials and guidance documents. This approach reflects the best practice principles of adult learning and was considered by many a strength of implementation.\u003csup\u003e24,35\u003c/sup\u003e However, dissatisfaction is not uncommon and is often attributed to limited access to timely in-person training and retraining.\u003csup\u003e1,5,16\u003c/sup\u003e Health workers in other LMICs have reported similar training gaps, highlighting systemic challenges in adult education approaches to digital health.\u003csup\u003e36\u003c/sup\u003e Cascade training of trainers approaches may address some of these issues while also supporting in-country capacity building and ownership.\u003csup\u003e1,37\u003c/sup\u003e Other effective training strategies may include supportive supervision and mentoring with enhanced engagement for lower-performing areas alongside routine EIR data reviews linked to action planning.\u003csup\u003e16\u003c/sup\u003e These activities are known to improve data quality, data use culture and accountability, and health outcomes in decentralised health systems.\u003csup\u003e38\u0026ndash;40\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eWe found overall high levels of self-reported computer literacy amongst the health workforce, consistent with data reported previously in Lao PDR and elsewhere.\u003csup\u003e5,37,41\u003c/sup\u003e This may have contributed to the observed high levels of acceptance of the EIR. Despite this, system-level factors such as shortages, high turnover, and the workload of health care workers are found to undermine the capacity to implement and use EIRs and health information systems, as other studies have found.\u003csup\u003e42,43\u003c/sup\u003e This pattern underscores that technology success depends less on individual capability than on system-level enablers such as adequate staffing, manageable workloads, and retention strategies.\u003c/p\u003e\n\u003cp\u003eA critical learning was the persistent gap between data collection and data use, a challenge that can undermine the investments in EIR infrastructure. We found an emerging immunisation \u0026ldquo;data use\u0026rdquo; culture among health system actors in Lao PDR but specific use of EIR data for decision-making and improving individual vaccine uptake was limited. This finding is unsurprising due to the initial emphasis on establishing foundational EIR data collection, a phenomenon also observed in Vanuatu.\u003csup\u003e43\u003c/sup\u003e Box 1 contains a vignette, drawing on several key informants\u0026rsquo; responses, on how they perceived the EIR could be used to proactively track children due or overdue for vaccination and to plan travel and inventory accordingly. The same pattern has emerged in early-stage implementations in countries such as Guinea, Honduras, Rwanda, and Tanzania, suggesting a similar trajectory where data collection precedes data use.\u003csup\u003e5\u003c/sup\u003e As systems and immunisation programs institutionalise the use of EIRs, efforts to incentivise EIR use will need to shift their focus to building individual skills to interpret data, addressing data quality concerns, and establishing processes (e.g., regular data review).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eData quality remains a challenge in the early stages of EIR implementation, with implications for global vaccination coverage estimates. In our study, data quality assessment identified several issues, including missing information in vaccination records (\u0026gt;15%), and timeliness of data entry with only 15% of vaccinations recorded within the recommended 3-days post-vaccination. These issues are not uncommon during the early stages of implementation,\u003csup\u003e44,45\u003c/sup\u003e however they highlight the need for ongoing training and supportive supervision, as well as adequate staffing, to ensure healthcare workers safeguard accuracy and completeness of data and coverage estimates over time.\u003csup\u003e43,46\u003c/sup\u003e It also continues to be important to improve civil registration and vital statistics systems and ensure EIR interoperability and implementation of unique identifiers. As registration improves, which appears to be occurring in the Lao PDR, the EIR offers an opportunity to improve target population estimates. Novel methods which use EIR and other data sources to better estimate target populations will be important and represent an opportunity for improving global immunisation coverage estimates, particularly in countries where civil registration systems remain weak.\u003csup\u003e47\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMost importantly, our evaluation in Lao PDR and other settings has demonstrated systemic challenges in translating data into public health action. This should be a key focus as countries, including the Lao PDR, look to expand and enhance EIR use to improve health outcomes.\u003csup\u003e43\u003c/sup\u003e This \u0026ldquo;last mile\u0026rdquo; challenge - converting digital data into tangible health improvements through outreach, resource allocation, and program implementation - remains a defining issue for digital health interventions globally.\u003csup\u003e48\u003c/sup\u003e Other health system issues, such as digital infrastructure (e.g. hardware and internet connectivity), are also barriers to EIR implementation. Countries across sub-Saharan Africa and remote areas of Asia and the Pacific face similar infrastructure constraints, including unreliable electricity, limited internet connectivity, and inadequate hardware budgets, which constrain EIR functionality.\u003csup\u003e49,50\u003c/sup\u003e The need for dual data entry across paper and digital systems increases healthcare workers\u0026rsquo; workload and potentially decreases efficiency and data accuracy compared to the use of paper or digital systems alone, as previously identified.\u003csup\u003e5,37\u003c/sup\u003e This is contentious, as there is evidence that mixed systems may be more successful in the long term by allowing time for health workers to adjust to the digital system.\u003csup\u003e51\u003c/sup\u003e However, it is generally acknowledged that migration to fully digital systems is needed to realise the full benefits of EIR.\u003csup\u003e5,51\u003c/sup\u003e In Vietnam for example, a readiness assessment of specific provinces identified barriers such as inadequate digital infrastructure in some facilities and supported a staged approach to transitioning to a fully digital system.\u003csup\u003e5,51\u003c/sup\u003e\u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe financing and governance architecture for EIRs carries implications beyond individual countries. Collaboration with external partners was seen as critical to the rollout of the Lao EIR, as reflected in experience in other LMICs.\u003csup\u003e5\u003c/sup\u003e However, as elsewhere, there was a perceived risk of over-reliance on external partners for funding and technical assistance, which could inadvertently undermine in-country priorities, independence, and capacity building.\u003csup\u003e5\u003c/sup\u003e This tension between necessary external support and the imperative for local ownership represents a central paradox of global health implementation, affecting not only EIRs but broader health system strengthening efforts worldwide.\u003csup\u003e52\u003c/sup\u003e Other studies have demonstrated that local governance, led by the Ministry of Health, was critical to sustainability and the consistent use of EIR in accordance with national guidelines.\u003csup\u003e1\u003c/sup\u003e In an illustration of the potential dangers of over-reliance on partner support, phasing out of external support resulted in the discontinuation of the EIR in a third of Tanzanian health facilities due to technical issues that could not be resolved locally, serving as a cautionary tale for countries dependent on external support for their digital health infrastructure.\u003csup\u003e5\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eLonger-term sustainability of EIRs in LMICs, including Lao PDR, will ultimately depend on maintenance of digital infrastructure, financial investment and clear governance mechanisms across the government and partner agencies. Understanding the economic implications of digital health interventions is crucial for planning sustainable implementation, as cost assessments can inform budget allocation and identify resource needs for maintaining EIR systems over time.\u003csup\u003e53\u003c/sup\u003e Formal governance mechanisms, such as technical working groups to oversee EIR implementation, enhanced national capacity and a costed and allocated budget, can enable increased local ownership.\u003csup\u003e1\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA strength of our study is its mixed-methods approach, which utilises established methods alongside pragmatic and innovative approaches to evaluate implementation, drawing on diverse indicators relating to workforce experience, data use, data quality, digital infrastructure, and governance. As a result, the evaluation highlights how these distinct system elements interact to enable or constrain EIR implementation and its potential to improve vaccination coverage.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAn important limitation of this evaluation arises from the lack of standardised indicators to measure EIR use and the capacity to collect and analyse data on costs associated with EIR implementation. Both are important areas for future research. The absence of standardised metrics hampers cross-country learning and represents a gap in the global digital health evidence base.\u003csup\u003e54\u003c/sup\u003e Other limitations include potential bias in facility and participant selection, as well as response bias. Due to the stage of Lao EIR implementation, as well as time and resource constraints, data collection was undertaken in 2 of 18 provinces, including the national capital, so responses may not be representative of other areas in Lao PDR, which may face more pronounced challenges with respect to rurality, internet connectivity and health workforce shortages. The overall positive perceptions of the EIR found in our study may have been influenced by response desirability bias. Additionally, age is a recognised influencer of digital capability, and the young age of our survey sample may be influenced by this.\u003csup\u003e55\u003c/sup\u003e Lastly, consumer and community perceptions of the EIR were not explored in this study but are an increasingly important consideration in enhancing the \u0026lsquo;people-centred\u0026rsquo; focus of healthcare alongside the growing presence of individual electronic health records.\u003csup\u003e47,56\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis is among the first studies to evaluate early implementation of an EIR in a LMIC setting. We demonstrated high levels of feasibility and acceptability, but that numerous individual and system-level barriers, including workforce capacity and capability, digital infrastructure, governance and financing, must be addressed in achieving and sustaining any potential impact of the EIR on vaccination coverage. Future studies should include implementation research to test strategies utilising EIRs in Lao PDR and similar settings to increase and sustain vaccination coverage, including among currently un- and under-immunised populations.\u0026nbsp;\u003c/p\u003e"},{"header":"Declarations","content":"\u003ch1\u003eAcknowledgements\u003c/h1\u003e\n\u003cp\u003eWe would like to thank Dr Jessica Hall and Ms Michelle Lynch for their contributions to project management and protocol development, and Ms Kanika Madan for supporting the data quality analysis. We thank Dr Amphone Keooudom, Dr Somphathai Bouathong, Mr Khamphet Luanglath, Mr Somkhit Bouavong, Ms Boualien Phon-Asa, and Mr Khamvieng Phommachanh for their support in data collection. We also thank the Lao PDR Ministry of Health for accompanying the study team during data collection and for their overall support for the project. \u0026nbsp;We would also like to thank Gavi, the Vaccine Alliance and the Government of Japan for providing financial support for the implementation of the EIR in Lao PDR.\u0026nbsp;\u003c/p\u003e\n\u003ch1\u003eAuthors\u0026rsquo; contributions\u003c/h1\u003e\n\u003cp\u003eMS conceptualised and supervised the study. MS, CP and GS designed the study with input from all authors. GS, MT, NC and MS collected the data. CP, GS, AV and AT analysed the data, with all authors involved in interpretation. CP, GS, PG and MS drafted the paper. All authors critically reviewed and provided input and approved the final version of the paper.\u003c/p\u003e\n\u003ch1\u003eConflicts of interests\u003c/h1\u003e\n\u003cp\u003eNone to declare.\u003c/p\u003e\n\u003ch1\u003eFunding\u003c/h1\u003e\n\u003cp\u003eThe project was funded from the Australian Government Department of Foreign Affairs and Trade Australian Expert Technical Assistance Program for Regional COVID-19 Vaccine Access: Policy, Planning and Implementation (AETAP-PPI) to the Australian Regional Immunisation Alliance (ARIA) (GID 212641)\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eCarnahan E, Nguyen L, Dao S, Bwakya M, Mtenga H, Duong H, et al. Design, development, and deployment of an electronic immunization registry: experiences from Vietnam, Tanzania, and Zambia. Glob Health Sci Pract. 2023 Feb 28;11(1):e2100804. \u003c/li\u003e\n\u003cli\u003eVigezzi GP, Maggioni E, Clavario L, Clerico Mosina L, Raso E, Marjin C, et al. 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Immunisation health workforce capacity building in Southeast Asia: reflections from training programme implementation in Cambodia and Lao PDR. BMJ Glob Health. 2025 Feb;10(2):e018007. \u003c/li\u003e\n\u003cli\u003eThe World Bank. Rural population (% of total population) - Lao PDR [Internet]. 2025 [cited 2025 Aug 9]. Available from: https://data.worldbank.org/indicator/SP.RUR.TOTL.ZS?locations=LA\u003c/li\u003e\n\u003cli\u003eRound Table Meeting- Lao PDR. Implementation of the 9th Health Sector Development Plan for the nine months of 2024 and the key direction for the year 2025 [Internet]. Vientiane Capital, Lao PDR; 2024. Available from: https://rtm.org.la/wp-content/uploads/2024/11/Summary-report_Implementation-of-9th-HSPD-for-9-months-of-2024-and-plan-for-2025_ENG.pdf#:~:text=-%20For%20the%20healthcare%20service%20system%20from,the%20district%20hospital%20levels%2C%201%2C080%20health%20centers;\u003c/li\u003e\n\u003cli\u003eDHIS2. DHIS2 Tracker [Internet]. 2025 [cited 2025 Aug 9]. 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Hum Vaccin Immunother. 2023;19(2):2257054. \u003c/li\u003e\n\u003cli\u003eSecor AM, Mtenga H, Richard J, Bulula N, Ferriss E, Rathod M, et al. Added Value of Electronic Immunization Registries in Low- and Middle-Income Countries: Observational Case Study in Tanzania. JMIR Public Health Surveill. 2022 Jan 21;8(1):e32455. \u003c/li\u003e\n\u003cli\u003eImmunization Agenda. Immunization Agenda 2030: A global strategy to leave no one behind [Internet]. 2020 [cited 2021 May 26]. Available from: https://www.who.int/teams/immunization-vaccines-and-biologicals/strategies/ia2030\u003c/li\u003e\n\u003cli\u003ePavia G, Branda F, Ciccozzi A, Romano C, Locci C, Azzena I, et al. Integrating Digital Health Solutions with Immunization Strategies: Improving Immunization Coverage and Monitoring in the Post-COVID-19 Era. Vaccines (Basel). 2024 Jul 28;12(8):847. \u003c/li\u003e\n\u003cli\u003eAdair-Rohani H, Zukor K, Bonjour S, Wilburn S, Kuesel AC, Hebert R, et al. Limited electricity access in health facilities of sub-Saharan Africa: a systematic review of data on electricity access, sources, and reliability. Global Health: Science and Practice. 2013 Aug 1;1(2):249\u0026ndash;61. \u003c/li\u003e\n\u003cli\u003eIrwin BR, Hoxha K, Gr\u0026eacute;pin KA. Conceptualising the effect of access to electricity on health in low- and middle-income countries: A systematic review. Global Public Health. 2020 Mar 3;15(3):452\u0026ndash;73. \u003c/li\u003e\n\u003cli\u003ePATH. Immunization Data: Evidence for Action. A Realist Review of What Works to Improve Data Use for Immunization, Evidence from Low- and MiddleIncome Countries. Seattle: [Internet]. Washington, DC: PAHO; 2019 [cited 2021 Aug 14]. Available from: https://path.azureedge.net/media/documents/PATH_IDEA_Precis_R1.pdf\u003c/li\u003e\n\u003cli\u003eNoor AM. Country ownership in global health. PLOS Global Public Health. 2022 Feb 11;2(2):e0000113. \u003c/li\u003e\n\u003cli\u003eFederici C, Verykiou M, Cavazza M, Olomi W, Irakiza P, Kayumba K, et al. The Costs of Digital Health Interventions to Improve Immunization Data in Low- and Middle-Income Countries: Multicountry Mixed Methods Study. J Med Internet Res. 2025 Aug 18;27:e62746. \u003c/li\u003e\n\u003cli\u003eBrenner M, Weir A, McCann M, Doyle C, Hughes M, Moen A, et al. Development of the key performance indicators for digital health interventions: A scoping review. Digit Health. 2023 Jan 22;9:20552076231152160. \u003c/li\u003e\n\u003cli\u003eAlotaibi N, Wilson CB, Traynor M. Enhancing digital readiness and capability in healthcare: a systematic review of interventions, barriers, and facilitators. BMC Health Services Research. 2025 Apr 4;25(1):500. \u003c/li\u003e\n\u003cli\u003eBalzarini F, Frascella B, Oradini-Alacreu A, Gaetti G, Lopalco PL, Edelstein M, et al. Does the use of personal electronic health records increase vaccine uptake? A systematic review. Vaccine. 2020 Aug 27;38(38):5966\u0026ndash;78.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 to 6 are available in the Supplementary Files section.\u003c/p\u003e"},{"header":"Box 1","content":"\u003cp\u003eBox 1 is available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"npj-digital-public-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"Learn more about [npj Digital Public Health](https://www.nature.com/npjdigipubhealth/)","snPcode":"44482","submissionUrl":"https://submission.springernature.com/new-submission/44482/3?","title":"npj Digital Public Health","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"NPJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-8664124/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8664124/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"The Lao People's Democratic Republic introduced an electronic immunisation registry (EIR) for routine immunisation in 2022. This study evaluated the EIR during its early stages to inform ongoing implementation and future use. We used a multi-method approach that involved five data sources: document review; health facility survey; key informant interviews; workflow observation; and data quality assessments. We surveyed 26 healthcare workers across 26 facilities. Respondents’ perceptions of the EIR were largely positive, though views on workload were mixed, and most indicated insufficient training and ongoing needs in data analysis and problem-solving. Only half consider infrastructure adequate. Eighteen stakeholder interviews highlighted strong uptake of the EIR and improved ability to generate reports and identify under-immunised children, but also persistent data gaps, limited data use, staff shortages, reliance on development partners, and the need for stronger government ownership, supervision, and a clear long-term roadmap. Data quality assessment of 849,055 non-duplicate vaccination events showed high levels of missing or invalid data and low timeliness of birth and vaccination registration; across four facilities, the EIR captured more doses than paper registers and district reports. This evaluation showed that EIR is feasible and acceptable, but individual and system-level barriers, particularly workforce capacity and capability, digital infrastructure, governance, and financing, must be addressed to realise its impact on vaccination coverage, underscoring the need for future implementation research to optimise EIR use in Lao PDR and similar settings.","manuscriptTitle":"Strengthening Immunisation Data Systems: a mixed methods evaluation of the Lao Electronic Immunisation Registry","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-02-03 15:57:08","doi":"10.21203/rs.3.rs-8664124/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2026-03-09T13:28:58+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-03-06T11:03:06+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"63516861747644878735899639725830663177","date":"2026-02-25T18:26:24+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-02-25T06:20:01+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"195522080738009209821393266850875431209","date":"2026-02-04T23:38:36+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-01-30T08:23:56+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-01-29T23:47:10+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-01-29T09:07:30+00:00","index":"","fulltext":""},{"type":"submitted","content":"npj Digital Public Health","date":"2026-01-22T01:09:54+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"npj-digital-public-health","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"Learn more about [npj Digital Public Health](https://www.nature.com/npjdigipubhealth/)","snPcode":"44482","submissionUrl":"https://submission.springernature.com/new-submission/44482/3?","title":"npj Digital Public Health","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"NPJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"9229063b-9243-4dfb-b305-cfcec2ee3a04","owner":[],"postedDate":"February 3rd, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[{"id":62015840,"name":"Health sciences/Health care"},{"id":62015841,"name":"Health sciences/Medical research"}],"tags":[],"updatedAt":"2026-04-14T01:54:58+00:00","versionOfRecord":[],"versionCreatedAt":"2026-02-03 15:57:08","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8664124","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8664124","identity":"rs-8664124","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}