Mapping data on access to and use of medicines among migrants in Flanders

Loes Meukens; Saleh Aljadeeah

doi:10.12688/f1000research.160320.1

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Study Protocol

Mapping data on access to and use of medicines among migrants in Flanders

[version 1; peer review: 3 approved with reservations]

Loes Meukens¹, Saleh Aljadeeah¹

PUBLISHED 06 Feb 2025

Author details Author details

¹ Department of Public Health, Institute of Tropical Medicine, Antwerp, Flanders, Belgium

Loes Meukens
Roles: Formal Analysis, Resources, Writing – Original Draft Preparation, Writing – Review & Editing

Saleh Aljadeeah
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Methodology, Project Administration, Resources, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS

This article is included in the Human Migration Research gateway.

Abstract

Background

Migration is a social determinant of health, and migrants often face health inequalities compared to host populations. Migrants are underrepresented in health research in many European countries, including Belgium, which is concerning. The World Health Organization (WHO) developed a comprehensive framework aimed at guiding research on migration and health within the WHO European Region. This initiative supports evidence-based policymaking among European member states by providing a foundational structure for examining various strategies and methodologies. The framework serves as a catalyst for discussion and critical analysis, contributing to the formulation of a global research agenda on migration and health under WHO’s leadership. Additionally, it outlines key research priorities and offers strategic recommendations to enhance the understanding and response to health issues related to migration. One of these recommendations calls on researchers to “maximise the use of existing data from research and routinely collected data in health information systems”.

Objective

The overarching aim of our Datahub initiative is to map available sources of datasets about access to and use of medicines among migrant populations, and test if and under which conditions they can be used in research, by taking the case of Flanders, Belgium.

Methods

This initiative will involve conducting a focused review to map datasets used for reporting access to and use of medicines among migrants, followed by a qualitative study with key informants; a structured analysis of ethical and legal challenges to be addressed when using the datasets we identified for research; and content description and evaluation of the different identified datasets.

Results

We assert that the results of our initiative will help presenting the diverse sources of data about medicines access or use among migrant populations. They will be also used to provide recommendations about enhancing the possibilities of retrieving, and using data, including recommendations for (legal, ethical, methodological) risk mitigation for retrieving and using these data.

Keywords

medicine, migrant, Flanders

Corresponding author: Saleh Aljadeeah

Competing interests: No competing interests were disclosed.

Grant information: This project is funded by the ITM Datahub (funded by the Department of Economy, Science & Innovation, Flanders).
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2025 Meukens L and Aljadeeah S. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: Meukens L and Aljadeeah S. Mapping data on access to and use of medicines among migrants in Flanders [version 1; peer review: 3 approved with reservations]. F1000Research 2025, 14:171 (https://doi.org/10.12688/f1000research.160320.1) First published: 06 Feb 2025, 14:171 (https://doi.org/10.12688/f1000research.160320.1) Latest published: 08 Jul 2025, 14:171 (https://doi.org/10.12688/f1000research.160320.2)

1. Introduction

1.1 Background

Migration is a longstanding and growing phenomenon.¹ The number of people living outside their countries of origin today is higher than at any time before.² Migration is a social determinant of health, and migrants often face health inequalities compared to host populations.^3,4 Migrants are underrepresented in health research in many European countries, including Belgium, which is concerning.⁵ In 2018, The UCL–Lancet Commission on Migration and Health called for more research into migration and health⁶ as there is an increasing need for data that can reflect the diversity of migrant populations and their diverse health needs.^5,7 Data are collected by different organisations, with different mandates (healthcare facilities, health insurance companies, NGOs, and -perhaps less frequently- research institutes). These data are very scattered.

Globally, the use of medicines stands as the most common used healthcare intervention and is fundamental to preventing, treating, and managing diseases.⁸ Ensuring fair and consistent access to essential medicines is a critical measure of a nation’s advancement toward achieving Universal Health Coverage.⁹ However, migrants across various European countries often encounter numerous barriers in their access to medicines.¹⁰ Historically, healthcare providers in humanitarian contexts have attempted to overcome these challenges without established systems for managing patient health records.¹¹ This absence of formal medical record systems significantly limits researchers’ ability to systematically assess the quality and access to healthcare services available to migrant populations. Studies exploring the impact of electronic health record (EHR) systems in aiding displaced communities highlight their potential to enhance access to medicines, improve health outcomes, and foster better adherence to medicines.¹¹

1.2 Rationale

The WHO presented a framework for migration and health research in the WHO European Region as part of its remit to support evidence-based decision-making in its member states in Europe.¹² This framework was designed as a starting point for debating and analysing a broad range of options and approaches to help inform a WHO-led global research agenda on migration and health. The framework offers several recommendations for research, including a call to “maximise the use of existing data from research and routinely collected data in health information systems”.¹²

Health information systems across Europe often lack comprehensive data on migrant populations, resulting in coverage gap in the data for this populations.¹³ This issue is not due to limitations in existing knowledge or technological capacity but is primarily shaped by political and ethical considerations.¹³ A major concern is that categorizing health data by migration status could potentially lead to discrimination against migrant groups. Additionally, collecting and disaggregating data on migrants is viewed as highly sensitive, raising ethical concerns aligned with established guidelines and the European Union’s General Data Protection Regulation (GDPR).^13,14 Nevertheless, the GDPR permits the processing of sensitive data under specific conditions, provided there are legitimate reasons and sufficient protective measures in place. EU data protection regulations do not prohibit the collection and analysis of personal or health data for vulnerable populations, such as migrants,^13,15 Instead, they offer frameworks to mitigate risks related to privacy and confidentiality.

Disaggregating and analyzing health data of migrant populations is essential for gaining a deeper understanding of their distinct healthcare needs and the challenges they face. Without utilizing these data in research, there is a risk of continuing the neglect of migrants’ unique health needs, resulting in inadequate healthcare responses and worsening disparities in access to health services, including essential medicines.^13,16–19 However, before such data can be effectively used, it is critical to thoroughly consider the ethical implications related to data collection, deidentification, processing, storage, analysis, and dissemination. Implementing strong pseudonymization or anonymization practices, along with secure systems to prevent patient re-identification, is vital to protecting the privacy of migrant populations. Ensuring data protection is particularly important to prevent the misuse of health data for non-health-related purposes, such as immigration enforcement.^13,15,17

In short, there is a need of a) mapping the different datasets that may include data about migrants’ access to and use of medicines; b) understanding how the different datasets can be deidentified and curated to ensure data protection, accuracy, completeness and coherence, as well as comparability across datasets; and c) identifying the methodological and ethical challenges related to accessing and using these datasets, and addressing these challenges with the ultimate aim of prioritizing the wellbeing and security of migrants. To address these needs, we will use the case of datasets that may contain direct or indirect information about access to medicine for migrants in Flanders, Belgium.

2. Study objectives

The overarching aim of this proposal is to map the available sources of data about access to and use of medicines among migrant populations in Flanders, Belgium, and assess if and under which conditions they can be used in M&E or research. It is important to recognize that this project does not aim to actually access data, but get information and guidance on how to access and curate data in a scientifically and ethically sound way. Any future plan to access and analyse datasets will be the object of a separate protocol.

The specific objectives are:

a) To map sources of data that contain information on access to and use of medicines among migrants.
b) To understand how different quantitative and/or qualitative data sources can be de-identified, curated, and assessed for accuracy, completeness and coherence, as well as comparability across datasets, for being used for M&E or research.
c) To identify and describe the challenges related to accessing and using these data, including ethical and legal challenges, and to develop and describe viable strategies and recommendations for deidentification, data curation and risk mitigation.
d) To assess the reliability and feasibility of applying the sources of data identified by this study in future research studies that aim at evaluating the access of/use of medicines among the diverse migrants population.

3. Study design

This project includes three separate stages ( Figure 1). During stage I, a focused review will be performed to collect information on different data sources that were used in published literature and reports in the relevant field. The outcome of a recently completed scoping review “Access to medicines among asylum seekers, refugees, and undocumented migrants across the migratory cycle in the European Union, European Economic Area, Switzerland and the UK: a scoping review”²⁰ led by the PI, which focused on access to medicines among migrants in Europe, will inform the focused review. Stage II will consist of qualitative interviews of key-informants in Flanders to discuss the possibilities of accessing, deidentifying and curating data, and of the ethical and legal challenges related to accessing and using these data. Key informants are a) those who are working in the collection, management and processing of datasets related access to or use of medicine (we will refer to them as data gatekeepers), and b) members of migrant communities. With stage III, we will discuss the reliability and feasibility of applying the identified data sources in scientifically and ethically sound research. This stage will imply triangulating the outcomes of Stage I and II, and formulating policy recommendations as well as recommendations for further research.

Figure 1. The overall sequential design of the research study, fractionated in three stages.

4. Methods

4.1 Procedures

4.1.1 Focused review:

We will perform a focused review to identify data sources that have been used in research and grey literature to report on access to medicine among migrants in Belgium. For this focused review we will follow the following steps:

a. Defining the scope and objectives: We will search for studies and grey literature sources that reported on access to medicine among migrants in two regions of Belgium: Flanders and Brussels.
b. Defining eligibility criteria: We will include studies and grey literature sources that have reported on access to and use of medicines among migrant populations in English and Dutch and was published after 2010.
c. Defining data Sources: We will also conduct our search on PubMed, Google Search, and websites of relevant governmental and non-governmental organisations, e.g. WHO, Médecins Sans Frontières, Médecins du Monde, Sciensano, FOD Volksgezondheid, Vlaams Agentschap Zorg en Gezondheid.
d. Screening and selecting materials: We will screen titles and abstracts against our inclusion criteria to identify potentially relevant documents. This will be followed by full text screening.
e. Data Extraction and Synthesis: We will extract data on the sources of data used in the studies and reports. In addition, we will extract the information about the challenges related to accessing, collecting and using these data for research. The identified common sources of data will be used for shaping the qualitative interviews in stage II.

4.1.2 Qualitative study:

Qualitative interviews will be conducted with key informants, i.e. data gatekeepers and migrant community members. Details are separately explained in chapters 4.2-4.4.

4.1.3 Triangulation of the outcomes of the first two steps:

We will compare the outcomes of the focused review (stage I) with the results of the qualitative interviews (stage II) highlighting areas of convergence, divergence, or expansion. The compared and contrasted outcomes of both studies will be presented and discussed with a research advisory group, comprising a group of researchers from the ITM (Karina Kielmann, Joris Michielsen, Houssynatou Sy, Mira Schneider, and Marie Meudec) and from Boston University (Veronika Wirtz), to broaden the understanding of the outcomes and formulate recommendations for further research. Table 1 lists a summary of the different stages that will take place during the study and the respective methods for data collection. More details are explained in chapter 4.

Table 1. Summary of project research objectives, questions, methods and logical sequence across the project stages.

Stages

Research objectives

Research questions

Methods and data sources

a- To map secondary data sources that contain information on access to and use of medicines among migrants.

Which sources/organizations in Flanders gather data on access to and use of medicines among migrants in Flanders?

A focused review to map datasets used for reporting access to and use of medicines among migrants

b- To understand how these different data sources can be accessed, deidentified and curated, and identify the methodological and ethical challenges related to accessing and using these data.

What are the challenges and facilitators of ethically accessing data on medicines access/use among migrants in Flanders?

Qualitative interviews with key informants
Thematic analyses

III

c- To discuss the reliability and feasibility of applying the identified data sources in research studies that aim of evaluating the access to/use of medicines among migrants population in Flanders.

How can these data be used in future research studies that aim of evaluating the access to/use of medicines among the migrants population in Flanders?

Content description and evaluation of the different identified data sources, including discussion and consultation with research partners

4.2 Study population

During stage II, qualitative interviews will be performed in order to obtain insights from community members and data gatekeepers in the use of data sources regarding access to and use of medicines among migrants in Flanders.

4.2.1 Inclusion criteria:

• Adult (≥ 18 years).
• Community members: migrants who have been living in Belgium for over 5 years and are active members of the community. These include individuals with migration background who are in leadership roles within community organizations and social clubs.
• Data gatekeepers: representatives of NGOs that provide care for migrants, staff of insurance companies, administrative and health staff in healthcare facilities (hospitals, outpatient clinics, pharmacies) in charge of collecting or processing data regarding access to or use of medicines, and other categories potentially identified through snowballing.
• Willing and able to provide written informed consent.

4.2.2 Exclusion criteria:

• Eligible persons who decline to consent to participation.
• Minors.

4.2.3 Recruitment and sampling:

Contacts from the social and professional network of the principal investigator (PI), co-investigators and scientific advisors will be purposively sampled, aiming at enrolling a diverse group with a broad range of experiences and perspectives. Snowball sampling will be used to identify other potential participants, for reaching out to more isolated groups. Given the diversity of the data sources, we will likely interview a higher number of the data gatekeepers in order to improve balance in including different groups of participants.

4.3 Data collection

Data will be collected by the Principal Investigator (SA) or co-investigator (LM) remotely via GDPR-compliant online platforms, or -preferably- by face-to-face interviews. Data will be collected through semi-structured qualitative interviews, conducted in English or Dutch, based on the preference of the participant.

It is estimated that approx. 10-20 participants will be needed. However, the exact sample size will depend on the quality and diversity of the data; recruitment will continue and data will be collected until saturation. Topic guides by categories are being developed. A draft version is submitted, which will be finalized in line with the findings of the mapping in Stage I.²²

Remote interviews will be conducted via European General Data Protection Regulation (GDPR)-compliant platforms (e.g. Teams), and according to participant’s preference. Face-to-face interviews will be conducted in a secure setting proposed by/agreed with the interviewee. The interview sessions (remote and in-person) will be audio-recorded, if the participant explicitly agrees to be recorded; otherwise, hand notes will be taken by the Principal Investigator or co-investigator.

4.4 Qualitative data analysis

The recordings will be transcribed, and translated into English when needed. Recordings will be deleted once transcription and cleaning are completed. No direct personal identifiers will be transcribed, including the name of the employer or names of third parties who could be mentioned during the interview. Word will be used for data transcription. Following the thematic content analysis approach suggested by Braun and Clarke,²¹ data will be coded and categorized and themes will be identified. This will involve collating codes into potential themes and gathering all data relevant to each potential theme.

5. Results

A study report will be shared with study participants through the same channels that were used to conduct the interviews with them, if they agreed to be further contacted by email for this scope. The study findings will form the basis for one or more open-access scientific publication(s) in a peer-reviewed journal. The outcomes will be also disseminated by means of a policy brief, conference presentations and meetings of NGOs active in assistance to migrants in Flanders or other relevant stakeholders who are involved in migrant assistance, healthcare or administrative affairs in Flanders. The policy briefs and dissemination to stakeholders are key for maximizing the social value of the study, and the likelihood that findings may provide useful guidance to improve the collection and use in research of data on migrants health.

Authors’ contributions

SA contributed to conceptualisation of the study, article selection, data collection through semi-structured qualitative interviews, data analysis, protocol drafting and critical revisions. LM contributed to article selection, data collection through semi-structured qualitative interviews, data analysis, protocol drafting and critical revisions.

Ethics review

The protocol was submitted for formal review and approval to the Institutional Review Board (IRB) of the Institute of Tropical Medicine [Approval number 1767/24; Date of approval 02/05/2024].

The study will be carried out according to the principles stated in the Declaration of Helsinki (2013 and any further revisions).

Informed Consent (IC) was obtained prior to interviews. Study participants (adults only) were informed that participation in the study is completely voluntary and that the participant can withdraw from the study at any time without any negative consequences.

The interviewer provided all the information about the study, and went through the Participant Information Sheet together with the participant in advance. The Data Protection Officer contact details were included in the ICF for questions about personal data processing.

Data availability statement

No data are associated with this article.

Extended data

Figshare: Interviews topic guides_ENG (version 2).pdf, https://doi.org/10.6084/m9.figshare.28219859.v1.²²

This project contains the following underlying data:

• Interviews topic guides_ENG (version 2).pdf

Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0).

Acknowledgements

We acknowledge all scientific advisors who have contributed to the development of this protocol. Members of the Institute of Tropical Medicine: Raffaella Ravinetto, Tom Smekens, Karina Kielmann, Joris Michielsen, Houssynatou Sy, Mira Schneider, and Marie Meudec. Members of the Institutional Review Board of the ITM. From partnering institution Boston University School of Public Health, we acknowledge Veronika Wirtz.

References

1. International Organization for Migration (IOM): World Migration Report 2022.2022. Reference Source
2. United Nations (UN): Peace, dignity and equality on a healthy planet 2020.Reference Source
3. World Health Organization (WHO): Refugee and migrant health 2020.Reference Source
4. Roura M, Dias S, LeMaster JW, et al.: Participatory health research with migrants: Opportunities, challenges, and way forwards. Health Expect. 2021; 24(2): 188–197. [published Online First: 2 February 2021]. PubMed Abstract | Publisher Full Text | Free Full Text
5. Aljadeeah S: Are Refugees (Really) a Hard-to-Survey Group? Fieldwork Experience with Syrian Refugees in Germany. J. Refug. Stud. 2022; 35(3): 1405–1409. Publisher Full Text
6. Orcutt M, Spiegel P, Kumar B, et al.: Lancet Migration: global collaboration to advance migration health. Lancet. 2020; 395(10221): 317–319. Publisher Full Text
7. Biddle L, Menold N, Bentner M, et al.: Health monitoring among asylum seekers and refugees: a state-wide, cross-sectional, population-based study in Germany. Emerg. Themes Epidemiol. 2019; 16: 3. [published Online First: 7 July 2019]. PubMed Abstract | Publisher Full Text | Free Full Text
8. Royal Pharmaceutical Society: Medicines Optimisation: Helping patients to make the most of medicines 2013.2016. Reference Source
9. World Health Organization (WHO): Towards Access 2030: WHO Medicines and Health Products Programme Strategic Framework 2016-2030.2017. Reference Source
10. Aljadeeah S, Wirtz VJ, Nagel E: Barriers to Accessing Medicines among Syrian Asylum Seekers and Refugees in a German Federal State. Int. J. Environ. Res. Public Health. 2021; 18(2). PubMed Abstract | Publisher Full Text | Free Full Text
11. Shrestha A, Alawa J, Ashworth H, et al.: Innovation is needed in creating electronic health records for humanitarian crises and displaced populations. Front. Digit. Health. 2022; 4: 939168. [published Online First: 29 September 2022]. PubMed Abstract | Publisher Full Text | Free Full Text
12. MacFarlane A, Puthoopparambil SJ, Waagensen E, et al.: Framework for refugee and migrant health research in the WHO European Region. Trop. Med. Int. Health. 2023; 28(2): 90–97. [published Online First: 23 January 2023]. PubMed Abstract | Publisher Full Text | Free Full Text
13. Bozorgmehr K, McKee M, Azzopardi-Muscat N, et al.: Integration of migrant and refugee data in health information systems in Europe: advancing evidence, policy and practice. Lancet Reg. Health Eur. 2023; 34: 100744. [published Online First: 27 October 2023]. PubMed Abstract | Publisher Full Text | Free Full Text
14. EUR-Lex: Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (Text with EEA relevance).2016. Accessed March 20, 2024. Reference Source
15. World Health Organization: Collection and integration of data on refugee and migrant health in the WHO European Region: technical guidance 2020. Accessed January 19, 2024. Reference Source
16. Chiesa V, Chiarenza A, Mosca D, et al.: Health records for migrants and refugees: A systematic review. Health Policy. 2019; 123(9): 888–900. [published Online First: 30 July 2019]. PubMed Abstract | Publisher Full Text
17. Migration in West and North Africa and across the Mediterranean: Trends, risks, development and governance. Geneva: International Organization for Migration; 2020.
18. Rechel B, Mladovsky P, Devillé W: Monitoring migrant health in Europe: a narrative review of data collection practices. Health Policy. 2012; 105(1): 10–16. [published Online First: 23 January 2012]. PubMed Abstract | Publisher Full Text
19. Juárez SP, Honkaniemi H, Dunlavy AC, et al.: Effects of non-health-targeted policies on migrant health: a systematic review and meta-analysis. Lancet Glob. Health. 2019; 7(4): e420–e435. [published Online First: 6 March 2019]. PubMed Abstract | Publisher Full Text | Free Full Text
20. Aljadeeah S, Payedimarri A, Kielmann K, et al.: Access to medicines among asylum seekers, refugees, and undocumented migrants across the migratory cycle in the European Union, European Economic Area, Switzerland and the UK: a scoping review.
21. Braun V, Clarke V: Using thematic analysis in psychology. Qual. Res. Psychol. 2006; 3(2): 77–101. Publisher Full Text
22. Meukens L, Aljadeeah S: Interviews topic guides_ENG (version 2).pdf. figshare. Preprint. 2025. Publisher Full Text

Comments on this article Comments (0)

Version 2

VERSION 2 PUBLISHED 06 Feb 2025

Author details Author details

¹ Department of Public Health, Institute of Tropical Medicine, Antwerp, Flanders, Belgium

Loes Meukens
Roles: Formal Analysis, Resources, Writing – Original Draft Preparation, Writing – Review & Editing

Competing interests

No competing interests were disclosed.

Grant information

This project is funded by the ITM Datahub (funded by the Department of Economy, Science & Innovation, Flanders).
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Article Versions (2)

version 2

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Published: 08 Jul 2025, 14:171

https://doi.org/10.12688/f1000research.160320.2

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Published: 06 Feb 2025, 14:171

https://doi.org/10.12688/f1000research.160320.1

© 2025 Meukens L and Aljadeeah S. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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Meukens L and Aljadeeah S. Mapping data on access to and use of medicines among migrants in Flanders [version 1; peer review: 3 approved with reservations]. F1000Research 2025, 14:171 (https://doi.org/10.12688/f1000research.160320.1)

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Reviewer Report 05 Mar 2025

Cheng Chow, The University of Texas at Austin, Austin, USA

Approved with Reservations

https://doi.org/10.5256/f1000research.176202.r368652

Overall: The authors aimed to map existing datasets on access to and use of medicines among migrant populations in Flanders, Belgium, and assess their feasibility for use in research and monitoring. Given the lack of comprehensive migration health data in Europe, this study has the potential to provide valuable insights into existing data sources and their usability. However, there are several areas that require clarification and improvement, as outlined below.

1. Tittle
The title accurately reflects the study’s focus on mapping datasets but does not fully capture the nature of the study as an initiative rather than an empirical research project. The authors may consider clarifying this distinction to ensure consistency between the study design and its presentation.

2. Background & Rationale
The background section is well-structured and provides a strong rationale for the study. However, there are some areas where additional clarification

2.1. The introduction spends significant space discussing WHO’s framework on migration and health without directly linking it to the study’s objectives. While the WHO framework provides a relevant backdrop, the authors should ensure that its relevance is explicitly stated. Please consider reducing the length of the WHO framework discussion and making a more explicit connection between the framework and the need for data-driven policy in Belgium.

2.2. The rationale for focusing on Flanders should be strengthened. While the manuscript mentions Belgium's lack of migrant health data, it would be helpful to explain why Flanders was chosen specifically rather than Belgium as a whole.

3. Study objectives
3.1. While the objectives are well defined, the current objectives mix data mapping, feasibility assessment, and ethical considerations without clearly delineating these as separate but interrelated research components. I would question what sources exist for data mapping, can these sources be used for research for data feasibility, and what are the barriers and possible solutions for ethnical and legal challenges?

3.2. Objective (b) mentions assessing datasets for accuracy, completeness, and coherence, but the methodology does not describe how these aspects will be evaluated. What criteria will be used to assess data completeness and accuracy? Will there be a scoring system or expert validation?

4. Methods
4.1. The exclusion of non-English/non-Dutch sources should be justified. Could relevant data sources exist in French, German, or other languages?

4.2. Will non-peer-reviewed (grey literature) sources be weighted differently in the analysis?

4.3. It is unclear how extracted data will be analyzed. Will the authors use a framework approach to categorize datasets?

4.4. The description of data gatekeepers is somewhat vague. It is unclear whether they include public health officials, policymakers, or dataset managers.

The recruitment of migrants does not specify whether different migrant groups (e.g., asylum seekers vs. economic migrants) will be considered. I believe the authors would agree with me that migration status, duration of study and many other factors significantly different across migrant groups.

5. Data Collection & Analysis
5.1. Will interviews be coded manually or using qualitative analysis software (e.g., NVivo)?

5.2. The GDPR compliance discussion is strong, but there is no mention of additional anonymization or security measures. Given the sensitivity of migrant health data, more emphasis on pseudonymization, encryption, and data storage security would be beneficial.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Migration, Health

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above.

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Author Response 21 Mar 2025

Loes Meukens, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

21 Mar 2025

Author Response

Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide ... Continue reading Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide responses to your comments by mid-April.
Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide responses to your comments by mid-April.
Competing Interests: No competing interests were disclosed. Close
Report a concern
Author Response 22 Jul 2025

Loes Meukens, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

22 Jul 2025

Author Response
Overall: The authors aimed to map existing datasets on access to and use of medicines among migrant populations in Flanders, Belgium, and assess their feasibility for use in research and ... Continue reading
Overall: The authors aimed to map existing datasets on access to and use of medicines among migrant populations in Flanders, Belgium, and assess their feasibility for use in research and monitoring. Given the lack of comprehensive migration health data in Europe, this study has the potential to provide valuable insights into existing data sources and their usability. However, there are several areas that require clarification and improvement, as outlined below.

1. Title
The title accurately reflects the study’s focus on mapping datasets but does not fully capture the nature of the study as an initiative rather than an empirical research project. The authors may consider clarifying this distinction to ensure consistency between the study design and its presentation.
We appreciate your feedback and your careful review of our manuscript. However, we respectfully disagree with the suggestion that the study is an initiative rather than an empirical research project. While Stage I involves a focused review of existing datasets, Stage II includes qualitative interviews. This empirical component involves the collection and analysis of primary data and thus qualifies the study as empirical research.

To avoid any potential misunderstanding, we have replaced the term “research initiative” with “research study” in the manuscript text where relevant, while retaining the original title, which we believe accurately reflects the aims of the study.

2. Background & Rationale
The background section is well-structured and provides a strong rationale for the study. However, there are some areas where additional clarification
Thank you for the positive feedback on the structure and rationale of the background section. Below are our replies to your suggestions about the various points that need clarification.

2.1. The introduction spends significant space discussing WHO’s framework on migration and health without directly linking it to the study’s objectives. While the WHO framework provides a relevant backdrop, the authors should ensure that its relevance is explicitly stated. Please consider reducing the length of the WHO framework discussion and making a more explicit connection between the framework and the need for data-driven policy in Belgium.
Thank you for your suggestion. We revised the text to clearly establish the connection between the WHO framework and the study’s focus on identifying and curating datasets that can inform data-driven policy and healthcare interventions for migrant populations in Belgium. You can find the revised text under section 1.2 Rationale.

2.2. The rationale for focusing on Flanders should be strengthened. While the manuscript mentions Belgium's lack of migrant health data, it would be helpful to explain why Flanders was chosen specifically rather than Belgium as a whole.

Thank you for your comment. We focused on Flanders specifically for pragmatic reasons. These include the language capacity of our research team, and the established network within Flanders, which is more concentrated in this region compared to other parts of Belgium. Expanding the study to include other regions would have introduced significant logistical challenges related to budget and time constraints, which could compromise the feasibility of the study. We acknowledge that this regional focus limits the generalizability of our findings to Belgium as a whole. However, we will clearly reflect on this limitation when discussing the outcomes of our study and outline the implications for future research in other regions of Belgium. We added the following to address your suggestion:
“We focused on Flanders due to pragmatic reasons related to the language capacity of our research team, and our established network in the region. Expanding to other regions of Belgium would have introduced logistical challenges, including language barriers, and increased costs and time constraints. We acknowledge that this regional focus limits the generalizability of our findings.”

3. Study objectives
3.1. While the objectives are well defined, the current objectives mix data mapping, feasibility assessment, and ethical considerations without clearly delineating these as separate but interrelated research components. I would question what sources exist for data mapping, can these sources be used for research for data feasibility, and what are the barriers and possible solutions for ethnical and legal challenges?
Thank you for your suggestion. We revised the description of the specific aims of our study to read:

“ A) Data mapping: This objective focuses on identifying existing datasets related to migrant medicine use in Flanders. We will assess the availability and coverage of these sources, considering whether they can be used for research and M&E purposes.

B) Feasibility Assessment: Our study will evaluate feasibility of applying the sources of data identified by this study in future research studies that aim at evaluating the access of/use of medicines among the diverse migrants population.

C) Ethical considerations: We will describe the challenges related to accessing and using these data, including ethical and legal challenges, and to develop and describe viable strategies and recommendations for deidentification, data curation and risk mitigation.”

3.2. Objective (b) mentions assessing datasets for accuracy, completeness, and coherence, but the methodology does not describe how these aspects will be evaluated. What criteria will be used to assess data completeness and accuracy? Will there be a scoring system or expert validation?

For the evaluation of accuracy, completeness, and coherence, we will conduct a focused review of the datasets used in reporting medicine use. This review will help identify any limitations or challenges within the data. We will then discuss these limitations in detail during the qualitative interviews with participants, allowing us to gather insights and validate the findings from the data sources. Through this process, we aim to assess the quality and reliability of the data from both a technical and a practical perspective.

4. Methods
4.1. The exclusion of non-English/non-Dutch sources should be justified. Could relevant data sources exist in French, German, or other languages?
Thank you for referring to this issue. As we addressed in our response to Reviewer 2 in Section 4.1.1, we focused on Dutch and English publications for this study. Dutch is the official language of Flanders and the primary language used in regional governmental and institutional reports. English was included due to its widespread use in academic publishing and its prominence in reports by international and non-governmental organizations. While French and German are also official languages in Belgium, it is less likely that literature specifically addressing migrants' access to healthcare in Flanders would be published exclusively in those languages.

4.2. Will non-peer-reviewed (grey literature) sources be weighted differently in the analysis?
Yes, we will include grey literature in our focused review. This is mentioned in section 4.1.1.

4.3. It is unclear how extracted data will be analyzed. Will the authors use a framework approach to categorize datasets?
We added the following under section “e. Data Extraction and Synthesis” to address your question:
“The data extracted of this focused review will be collated, summarized and reported in a manner that aligns with the aim of the focused review. We will conduct thematic analysis and present its outcomes in a narrative format.”

4.4. The description of data gatekeepers is somewhat vague. It is unclear whether they include public health officials, policymakers, or dataset managers.
We agree that further clarification could be helpful. In the revised text, we have now explicitly included representatives of public health offices or institutions among the data gatekeepers.

The recruitment of migrants does not specify whether different migrant groups (e.g., asylum seekers vs. economic migrants) will be considered. I believe the authors would agree with me that migration status, duration of study and many other factors significantly different across migrant groups.
As noted, our study focuses on migrants who have been living in Belgium for over five years and who are active members of the migrant community. This includes individuals with diverse migration backgrounds—such as former asylum seekers, refugees, or economic migrants—who are currently in leadership roles within community organizations or social groups. While we do not select participants based on their current legal status, we intentionally target those who are well-connected within the community and familiar with the challenges migrants face in accessing medicines. This approach allows us to gather informed insights while capturing a range of experiences across different migrant groups.

5. Data Collection & Analysis
5.1. Will interviews be coded manually or using qualitative analysis software (e.g., NVivo)?
Thank you for this question. The interviews will be coded manually, using Microsoft Word.

5.2. The GDPR compliance discussion is strong, but there is no mention of additional anonymization or security measures. Given the sensitivity of migrant health data, more emphasis on pseudonymization, encryption, and data storage security would be beneficial.
Thank you for your suggestion. We have expanded the manuscript as follows to include a more detailed explanation of the anonymization and data security measures that will be taken throughout the study:
“In the Stage I of the study, when performing the focused review, no personal data will be processed. For the Stage II, when conducting the interviews, the lawful ground for the processing of the participant personal data will be the written consent of the participant. The study will also be entered in the Institute of Tropical Medicine GDPR registry of personal data processing activities and the requirements are reviewed by the Data Protection Officer. All study data will be pseudonymized at the earliest convenience. Identifiers are retained at a separate and secure location, and deleted (full anonymization) after the study is published. Identifiable information in any audio or videocall recording will also be minimized to the extent possible.”
Overall: The authors aimed to map existing datasets on access to and use of medicines among migrant populations in Flanders, Belgium, and assess their feasibility for use in research and monitoring. Given the lack of comprehensive migration health data in Europe, this study has the potential to provide valuable insights into existing data sources and their usability. However, there are several areas that require clarification and improvement, as outlined below.

1. Title
The title accurately reflects the study’s focus on mapping datasets but does not fully capture the nature of the study as an initiative rather than an empirical research project. The authors may consider clarifying this distinction to ensure consistency between the study design and its presentation.
We appreciate your feedback and your careful review of our manuscript. However, we respectfully disagree with the suggestion that the study is an initiative rather than an empirical research project. While Stage I involves a focused review of existing datasets, Stage II includes qualitative interviews. This empirical component involves the collection and analysis of primary data and thus qualifies the study as empirical research.

To avoid any potential misunderstanding, we have replaced the term “research initiative” with “research study” in the manuscript text where relevant, while retaining the original title, which we believe accurately reflects the aims of the study.

2. Background & Rationale
The background section is well-structured and provides a strong rationale for the study. However, there are some areas where additional clarification
Thank you for the positive feedback on the structure and rationale of the background section. Below are our replies to your suggestions about the various points that need clarification.

2.1. The introduction spends significant space discussing WHO’s framework on migration and health without directly linking it to the study’s objectives. While the WHO framework provides a relevant backdrop, the authors should ensure that its relevance is explicitly stated. Please consider reducing the length of the WHO framework discussion and making a more explicit connection between the framework and the need for data-driven policy in Belgium.
Thank you for your suggestion. We revised the text to clearly establish the connection between the WHO framework and the study’s focus on identifying and curating datasets that can inform data-driven policy and healthcare interventions for migrant populations in Belgium. You can find the revised text under section 1.2 Rationale.

2.2. The rationale for focusing on Flanders should be strengthened. While the manuscript mentions Belgium's lack of migrant health data, it would be helpful to explain why Flanders was chosen specifically rather than Belgium as a whole.

Thank you for your comment. We focused on Flanders specifically for pragmatic reasons. These include the language capacity of our research team, and the established network within Flanders, which is more concentrated in this region compared to other parts of Belgium. Expanding the study to include other regions would have introduced significant logistical challenges related to budget and time constraints, which could compromise the feasibility of the study. We acknowledge that this regional focus limits the generalizability of our findings to Belgium as a whole. However, we will clearly reflect on this limitation when discussing the outcomes of our study and outline the implications for future research in other regions of Belgium. We added the following to address your suggestion:
“We focused on Flanders due to pragmatic reasons related to the language capacity of our research team, and our established network in the region. Expanding to other regions of Belgium would have introduced logistical challenges, including language barriers, and increased costs and time constraints. We acknowledge that this regional focus limits the generalizability of our findings.”

3. Study objectives
3.1. While the objectives are well defined, the current objectives mix data mapping, feasibility assessment, and ethical considerations without clearly delineating these as separate but interrelated research components. I would question what sources exist for data mapping, can these sources be used for research for data feasibility, and what are the barriers and possible solutions for ethnical and legal challenges?
Thank you for your suggestion. We revised the description of the specific aims of our study to read:

“ A) Data mapping: This objective focuses on identifying existing datasets related to migrant medicine use in Flanders. We will assess the availability and coverage of these sources, considering whether they can be used for research and M&E purposes.

B) Feasibility Assessment: Our study will evaluate feasibility of applying the sources of data identified by this study in future research studies that aim at evaluating the access of/use of medicines among the diverse migrants population.

C) Ethical considerations: We will describe the challenges related to accessing and using these data, including ethical and legal challenges, and to develop and describe viable strategies and recommendations for deidentification, data curation and risk mitigation.”

3.2. Objective (b) mentions assessing datasets for accuracy, completeness, and coherence, but the methodology does not describe how these aspects will be evaluated. What criteria will be used to assess data completeness and accuracy? Will there be a scoring system or expert validation?

For the evaluation of accuracy, completeness, and coherence, we will conduct a focused review of the datasets used in reporting medicine use. This review will help identify any limitations or challenges within the data. We will then discuss these limitations in detail during the qualitative interviews with participants, allowing us to gather insights and validate the findings from the data sources. Through this process, we aim to assess the quality and reliability of the data from both a technical and a practical perspective.

4. Methods
4.1. The exclusion of non-English/non-Dutch sources should be justified. Could relevant data sources exist in French, German, or other languages?
Thank you for referring to this issue. As we addressed in our response to Reviewer 2 in Section 4.1.1, we focused on Dutch and English publications for this study. Dutch is the official language of Flanders and the primary language used in regional governmental and institutional reports. English was included due to its widespread use in academic publishing and its prominence in reports by international and non-governmental organizations. While French and German are also official languages in Belgium, it is less likely that literature specifically addressing migrants' access to healthcare in Flanders would be published exclusively in those languages.

4.2. Will non-peer-reviewed (grey literature) sources be weighted differently in the analysis?
Yes, we will include grey literature in our focused review. This is mentioned in section 4.1.1.

4.3. It is unclear how extracted data will be analyzed. Will the authors use a framework approach to categorize datasets?
We added the following under section “e. Data Extraction and Synthesis” to address your question:
“The data extracted of this focused review will be collated, summarized and reported in a manner that aligns with the aim of the focused review. We will conduct thematic analysis and present its outcomes in a narrative format.”

4.4. The description of data gatekeepers is somewhat vague. It is unclear whether they include public health officials, policymakers, or dataset managers.
We agree that further clarification could be helpful. In the revised text, we have now explicitly included representatives of public health offices or institutions among the data gatekeepers.

The recruitment of migrants does not specify whether different migrant groups (e.g., asylum seekers vs. economic migrants) will be considered. I believe the authors would agree with me that migration status, duration of study and many other factors significantly different across migrant groups.
As noted, our study focuses on migrants who have been living in Belgium for over five years and who are active members of the migrant community. This includes individuals with diverse migration backgrounds—such as former asylum seekers, refugees, or economic migrants—who are currently in leadership roles within community organizations or social groups. While we do not select participants based on their current legal status, we intentionally target those who are well-connected within the community and familiar with the challenges migrants face in accessing medicines. This approach allows us to gather informed insights while capturing a range of experiences across different migrant groups.

5. Data Collection & Analysis
5.1. Will interviews be coded manually or using qualitative analysis software (e.g., NVivo)?
Thank you for this question. The interviews will be coded manually, using Microsoft Word.

5.2. The GDPR compliance discussion is strong, but there is no mention of additional anonymization or security measures. Given the sensitivity of migrant health data, more emphasis on pseudonymization, encryption, and data storage security would be beneficial.
Thank you for your suggestion. We have expanded the manuscript as follows to include a more detailed explanation of the anonymization and data security measures that will be taken throughout the study:
“In the Stage I of the study, when performing the focused review, no personal data will be processed. For the Stage II, when conducting the interviews, the lawful ground for the processing of the participant personal data will be the written consent of the participant. The study will also be entered in the Institute of Tropical Medicine GDPR registry of personal data processing activities and the requirements are reviewed by the Data Protection Officer. All study data will be pseudonymized at the earliest convenience. Identifiers are retained at a separate and secure location, and deleted (full anonymization) after the study is published. Identifiable information in any audio or videocall recording will also be minimized to the extent possible.”
Competing Interests: No competing interests were disclosed. Close
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Respond or Comment

COMMENTS ON THIS REPORT

Author Response 21 Mar 2025

Loes Meukens, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

21 Mar 2025

Author Response

Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide ... Continue reading Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide responses to your comments by mid-April.
Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide responses to your comments by mid-April.
Competing Interests: No competing interests were disclosed. Close
Report a concern
Author Response 22 Jul 2025

Loes Meukens, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

22 Jul 2025

Author Response
Overall: The authors aimed to map existing datasets on access to and use of medicines among migrant populations in Flanders, Belgium, and assess their feasibility for use in research and ... Continue reading
Overall: The authors aimed to map existing datasets on access to and use of medicines among migrant populations in Flanders, Belgium, and assess their feasibility for use in research and monitoring. Given the lack of comprehensive migration health data in Europe, this study has the potential to provide valuable insights into existing data sources and their usability. However, there are several areas that require clarification and improvement, as outlined below.

1. Title
The title accurately reflects the study’s focus on mapping datasets but does not fully capture the nature of the study as an initiative rather than an empirical research project. The authors may consider clarifying this distinction to ensure consistency between the study design and its presentation.
We appreciate your feedback and your careful review of our manuscript. However, we respectfully disagree with the suggestion that the study is an initiative rather than an empirical research project. While Stage I involves a focused review of existing datasets, Stage II includes qualitative interviews. This empirical component involves the collection and analysis of primary data and thus qualifies the study as empirical research.

To avoid any potential misunderstanding, we have replaced the term “research initiative” with “research study” in the manuscript text where relevant, while retaining the original title, which we believe accurately reflects the aims of the study.

2. Background & Rationale
The background section is well-structured and provides a strong rationale for the study. However, there are some areas where additional clarification
Thank you for the positive feedback on the structure and rationale of the background section. Below are our replies to your suggestions about the various points that need clarification.

2.1. The introduction spends significant space discussing WHO’s framework on migration and health without directly linking it to the study’s objectives. While the WHO framework provides a relevant backdrop, the authors should ensure that its relevance is explicitly stated. Please consider reducing the length of the WHO framework discussion and making a more explicit connection between the framework and the need for data-driven policy in Belgium.
Thank you for your suggestion. We revised the text to clearly establish the connection between the WHO framework and the study’s focus on identifying and curating datasets that can inform data-driven policy and healthcare interventions for migrant populations in Belgium. You can find the revised text under section 1.2 Rationale.

2.2. The rationale for focusing on Flanders should be strengthened. While the manuscript mentions Belgium's lack of migrant health data, it would be helpful to explain why Flanders was chosen specifically rather than Belgium as a whole.

Thank you for your comment. We focused on Flanders specifically for pragmatic reasons. These include the language capacity of our research team, and the established network within Flanders, which is more concentrated in this region compared to other parts of Belgium. Expanding the study to include other regions would have introduced significant logistical challenges related to budget and time constraints, which could compromise the feasibility of the study. We acknowledge that this regional focus limits the generalizability of our findings to Belgium as a whole. However, we will clearly reflect on this limitation when discussing the outcomes of our study and outline the implications for future research in other regions of Belgium. We added the following to address your suggestion:
“We focused on Flanders due to pragmatic reasons related to the language capacity of our research team, and our established network in the region. Expanding to other regions of Belgium would have introduced logistical challenges, including language barriers, and increased costs and time constraints. We acknowledge that this regional focus limits the generalizability of our findings.”

3. Study objectives
3.1. While the objectives are well defined, the current objectives mix data mapping, feasibility assessment, and ethical considerations without clearly delineating these as separate but interrelated research components. I would question what sources exist for data mapping, can these sources be used for research for data feasibility, and what are the barriers and possible solutions for ethnical and legal challenges?
Thank you for your suggestion. We revised the description of the specific aims of our study to read:

“ A) Data mapping: This objective focuses on identifying existing datasets related to migrant medicine use in Flanders. We will assess the availability and coverage of these sources, considering whether they can be used for research and M&E purposes.

B) Feasibility Assessment: Our study will evaluate feasibility of applying the sources of data identified by this study in future research studies that aim at evaluating the access of/use of medicines among the diverse migrants population.

C) Ethical considerations: We will describe the challenges related to accessing and using these data, including ethical and legal challenges, and to develop and describe viable strategies and recommendations for deidentification, data curation and risk mitigation.”

3.2. Objective (b) mentions assessing datasets for accuracy, completeness, and coherence, but the methodology does not describe how these aspects will be evaluated. What criteria will be used to assess data completeness and accuracy? Will there be a scoring system or expert validation?

For the evaluation of accuracy, completeness, and coherence, we will conduct a focused review of the datasets used in reporting medicine use. This review will help identify any limitations or challenges within the data. We will then discuss these limitations in detail during the qualitative interviews with participants, allowing us to gather insights and validate the findings from the data sources. Through this process, we aim to assess the quality and reliability of the data from both a technical and a practical perspective.

4. Methods
4.1. The exclusion of non-English/non-Dutch sources should be justified. Could relevant data sources exist in French, German, or other languages?
Thank you for referring to this issue. As we addressed in our response to Reviewer 2 in Section 4.1.1, we focused on Dutch and English publications for this study. Dutch is the official language of Flanders and the primary language used in regional governmental and institutional reports. English was included due to its widespread use in academic publishing and its prominence in reports by international and non-governmental organizations. While French and German are also official languages in Belgium, it is less likely that literature specifically addressing migrants' access to healthcare in Flanders would be published exclusively in those languages.

4.2. Will non-peer-reviewed (grey literature) sources be weighted differently in the analysis?
Yes, we will include grey literature in our focused review. This is mentioned in section 4.1.1.

4.3. It is unclear how extracted data will be analyzed. Will the authors use a framework approach to categorize datasets?
We added the following under section “e. Data Extraction and Synthesis” to address your question:
“The data extracted of this focused review will be collated, summarized and reported in a manner that aligns with the aim of the focused review. We will conduct thematic analysis and present its outcomes in a narrative format.”

4.4. The description of data gatekeepers is somewhat vague. It is unclear whether they include public health officials, policymakers, or dataset managers.
We agree that further clarification could be helpful. In the revised text, we have now explicitly included representatives of public health offices or institutions among the data gatekeepers.

The recruitment of migrants does not specify whether different migrant groups (e.g., asylum seekers vs. economic migrants) will be considered. I believe the authors would agree with me that migration status, duration of study and many other factors significantly different across migrant groups.
As noted, our study focuses on migrants who have been living in Belgium for over five years and who are active members of the migrant community. This includes individuals with diverse migration backgrounds—such as former asylum seekers, refugees, or economic migrants—who are currently in leadership roles within community organizations or social groups. While we do not select participants based on their current legal status, we intentionally target those who are well-connected within the community and familiar with the challenges migrants face in accessing medicines. This approach allows us to gather informed insights while capturing a range of experiences across different migrant groups.

5. Data Collection & Analysis
5.1. Will interviews be coded manually or using qualitative analysis software (e.g., NVivo)?
Thank you for this question. The interviews will be coded manually, using Microsoft Word.

5.2. The GDPR compliance discussion is strong, but there is no mention of additional anonymization or security measures. Given the sensitivity of migrant health data, more emphasis on pseudonymization, encryption, and data storage security would be beneficial.
Thank you for your suggestion. We have expanded the manuscript as follows to include a more detailed explanation of the anonymization and data security measures that will be taken throughout the study:
“In the Stage I of the study, when performing the focused review, no personal data will be processed. For the Stage II, when conducting the interviews, the lawful ground for the processing of the participant personal data will be the written consent of the participant. The study will also be entered in the Institute of Tropical Medicine GDPR registry of personal data processing activities and the requirements are reviewed by the Data Protection Officer. All study data will be pseudonymized at the earliest convenience. Identifiers are retained at a separate and secure location, and deleted (full anonymization) after the study is published. Identifiable information in any audio or videocall recording will also be minimized to the extent possible.”
Overall: The authors aimed to map existing datasets on access to and use of medicines among migrant populations in Flanders, Belgium, and assess their feasibility for use in research and monitoring. Given the lack of comprehensive migration health data in Europe, this study has the potential to provide valuable insights into existing data sources and their usability. However, there are several areas that require clarification and improvement, as outlined below.

1. Title
The title accurately reflects the study’s focus on mapping datasets but does not fully capture the nature of the study as an initiative rather than an empirical research project. The authors may consider clarifying this distinction to ensure consistency between the study design and its presentation.
We appreciate your feedback and your careful review of our manuscript. However, we respectfully disagree with the suggestion that the study is an initiative rather than an empirical research project. While Stage I involves a focused review of existing datasets, Stage II includes qualitative interviews. This empirical component involves the collection and analysis of primary data and thus qualifies the study as empirical research.

To avoid any potential misunderstanding, we have replaced the term “research initiative” with “research study” in the manuscript text where relevant, while retaining the original title, which we believe accurately reflects the aims of the study.

2. Background & Rationale
The background section is well-structured and provides a strong rationale for the study. However, there are some areas where additional clarification
Thank you for the positive feedback on the structure and rationale of the background section. Below are our replies to your suggestions about the various points that need clarification.

2.1. The introduction spends significant space discussing WHO’s framework on migration and health without directly linking it to the study’s objectives. While the WHO framework provides a relevant backdrop, the authors should ensure that its relevance is explicitly stated. Please consider reducing the length of the WHO framework discussion and making a more explicit connection between the framework and the need for data-driven policy in Belgium.
Thank you for your suggestion. We revised the text to clearly establish the connection between the WHO framework and the study’s focus on identifying and curating datasets that can inform data-driven policy and healthcare interventions for migrant populations in Belgium. You can find the revised text under section 1.2 Rationale.

2.2. The rationale for focusing on Flanders should be strengthened. While the manuscript mentions Belgium's lack of migrant health data, it would be helpful to explain why Flanders was chosen specifically rather than Belgium as a whole.

Thank you for your comment. We focused on Flanders specifically for pragmatic reasons. These include the language capacity of our research team, and the established network within Flanders, which is more concentrated in this region compared to other parts of Belgium. Expanding the study to include other regions would have introduced significant logistical challenges related to budget and time constraints, which could compromise the feasibility of the study. We acknowledge that this regional focus limits the generalizability of our findings to Belgium as a whole. However, we will clearly reflect on this limitation when discussing the outcomes of our study and outline the implications for future research in other regions of Belgium. We added the following to address your suggestion:
“We focused on Flanders due to pragmatic reasons related to the language capacity of our research team, and our established network in the region. Expanding to other regions of Belgium would have introduced logistical challenges, including language barriers, and increased costs and time constraints. We acknowledge that this regional focus limits the generalizability of our findings.”

3. Study objectives
3.1. While the objectives are well defined, the current objectives mix data mapping, feasibility assessment, and ethical considerations without clearly delineating these as separate but interrelated research components. I would question what sources exist for data mapping, can these sources be used for research for data feasibility, and what are the barriers and possible solutions for ethnical and legal challenges?
Thank you for your suggestion. We revised the description of the specific aims of our study to read:

“ A) Data mapping: This objective focuses on identifying existing datasets related to migrant medicine use in Flanders. We will assess the availability and coverage of these sources, considering whether they can be used for research and M&E purposes.

B) Feasibility Assessment: Our study will evaluate feasibility of applying the sources of data identified by this study in future research studies that aim at evaluating the access of/use of medicines among the diverse migrants population.

C) Ethical considerations: We will describe the challenges related to accessing and using these data, including ethical and legal challenges, and to develop and describe viable strategies and recommendations for deidentification, data curation and risk mitigation.”

3.2. Objective (b) mentions assessing datasets for accuracy, completeness, and coherence, but the methodology does not describe how these aspects will be evaluated. What criteria will be used to assess data completeness and accuracy? Will there be a scoring system or expert validation?

For the evaluation of accuracy, completeness, and coherence, we will conduct a focused review of the datasets used in reporting medicine use. This review will help identify any limitations or challenges within the data. We will then discuss these limitations in detail during the qualitative interviews with participants, allowing us to gather insights and validate the findings from the data sources. Through this process, we aim to assess the quality and reliability of the data from both a technical and a practical perspective.

4. Methods
4.1. The exclusion of non-English/non-Dutch sources should be justified. Could relevant data sources exist in French, German, or other languages?
Thank you for referring to this issue. As we addressed in our response to Reviewer 2 in Section 4.1.1, we focused on Dutch and English publications for this study. Dutch is the official language of Flanders and the primary language used in regional governmental and institutional reports. English was included due to its widespread use in academic publishing and its prominence in reports by international and non-governmental organizations. While French and German are also official languages in Belgium, it is less likely that literature specifically addressing migrants' access to healthcare in Flanders would be published exclusively in those languages.

4.2. Will non-peer-reviewed (grey literature) sources be weighted differently in the analysis?
Yes, we will include grey literature in our focused review. This is mentioned in section 4.1.1.

4.3. It is unclear how extracted data will be analyzed. Will the authors use a framework approach to categorize datasets?
We added the following under section “e. Data Extraction and Synthesis” to address your question:
“The data extracted of this focused review will be collated, summarized and reported in a manner that aligns with the aim of the focused review. We will conduct thematic analysis and present its outcomes in a narrative format.”

4.4. The description of data gatekeepers is somewhat vague. It is unclear whether they include public health officials, policymakers, or dataset managers.
We agree that further clarification could be helpful. In the revised text, we have now explicitly included representatives of public health offices or institutions among the data gatekeepers.

The recruitment of migrants does not specify whether different migrant groups (e.g., asylum seekers vs. economic migrants) will be considered. I believe the authors would agree with me that migration status, duration of study and many other factors significantly different across migrant groups.
As noted, our study focuses on migrants who have been living in Belgium for over five years and who are active members of the migrant community. This includes individuals with diverse migration backgrounds—such as former asylum seekers, refugees, or economic migrants—who are currently in leadership roles within community organizations or social groups. While we do not select participants based on their current legal status, we intentionally target those who are well-connected within the community and familiar with the challenges migrants face in accessing medicines. This approach allows us to gather informed insights while capturing a range of experiences across different migrant groups.

5. Data Collection & Analysis
5.1. Will interviews be coded manually or using qualitative analysis software (e.g., NVivo)?
Thank you for this question. The interviews will be coded manually, using Microsoft Word.

5.2. The GDPR compliance discussion is strong, but there is no mention of additional anonymization or security measures. Given the sensitivity of migrant health data, more emphasis on pseudonymization, encryption, and data storage security would be beneficial.
Thank you for your suggestion. We have expanded the manuscript as follows to include a more detailed explanation of the anonymization and data security measures that will be taken throughout the study:
“In the Stage I of the study, when performing the focused review, no personal data will be processed. For the Stage II, when conducting the interviews, the lawful ground for the processing of the participant personal data will be the written consent of the participant. The study will also be entered in the Institute of Tropical Medicine GDPR registry of personal data processing activities and the requirements are reviewed by the Data Protection Officer. All study data will be pseudonymized at the earliest convenience. Identifiers are retained at a separate and secure location, and deleted (full anonymization) after the study is published. Identifiable information in any audio or videocall recording will also be minimized to the extent possible.”
Competing Interests: No competing interests were disclosed. Close
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Views

Reviewer Report 03 Mar 2025

Yu par Khin, Institute of Science Tokyo, Tokyo, Japan

Approved with Reservations

https://doi.org/10.5256/f1000research.176202.r368648

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Access to healthcare by migrant, Qualitative research, Systematic review

CITE

Report a concern

Author Response 21 Mar 2025

Loes Meukens, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

21 Mar 2025

Author Response

Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide ... Continue reading Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide responses to your comments by mid-April.
Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide responses to your comments by mid-April.
Competing Interests: No competing interests were disclosed. Close
Report a concern
Author Response 08 Jul 2025

Loes Meukens, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

08 Jul 2025

Author Response

Thank you for giving me opportunity to review this article. This protocol aims to map available data sources on migrants' access to medicines in Flanders, Belgium. I think this is ... Continue reading Thank you for giving me opportunity to review this article. This protocol aims to map available data sources on migrants' access to medicines in Flanders, Belgium. I think this is a great effort and would have scientific impact. I have a few comments on the following topics.
We appreciate your thoughtful review of our protocol. Your comments and suggestions have been very helpful in improving our protocol. Below, we respond to all comments.

Abstract
1.Objective
This study is to map the available datasets about access to and use of medicines. I am wondering is it the prescription based medical access to OTC medication?
Thank you for this question. Both prescription based medication and OTC medication are of interest in this study.

2. Keywords
I think "access" is one of the keywords.
Thank you for this observation. We added “access” to the key words.

3. Introduction
1. I understand that data protection is important to protect the migrant population. It would be great if the introduction can add the following information.
1.a. How people access medicine in Belgium and other EU countries and why migrants can be left behind?
Thank you for this suggestion. We have added the following to address you suggestion:
“Access to essential medicines for migrants in Europe varies significantly across countries due to differences in healthcare systems, legal frameworks, and the socio-political status of migrants. Migrants, particularly asylum seekers, refugees, and undocumented migrants, often face substantial barriers to accessing medicines. These barriers include limited legal entitlements, financial constraints, language issues, and lack of familiarity with healthcare systems. In many EU countries, asylum seekers and undocumented migrants may be excluded from national health insurance systems or face long waiting periods for coverage, which can delay or restrict access to essential medications. In Belgium, asylum seekers are entitled to medical care under the "Aide Médicale Urgente" (AMU) system, which covers urgent and necessary healthcare, including some essential medicines. However, this provision often does not cover the full range of chronic disease treatments. While some NGOs and local health actors provide support to fill these gaps, persistent challenges remain, underscoring the need for more inclusive and coordinated policies and better data to ensure equitable access to medicines for all migrant populations.”

Methods
4.1.1. b. Do you mean literature published in English and Dutch? Why do you particularly choose these two languages but not others like German or French?
We focused on Dutch and English publications. Dutch is the official language of Flanders, making it the primary language for regional governmental and institutional reports. English was included due to its widespread use in academic publishing and its prominence in reports by international and non-governmental organizations. While French and German are also official languages in Belgium, it is less likely that literature specifically addressing migrants’ access to healthcare in Flanders would be published exclusively in those languages.

4.1.3. It would be great if you can describe more elaboratively on how the qualitative interviews be compared with the finding from Stage I. On which part and how?
We added the following to address your suggestion:
“To enable meaningful triangulation, we will compare the types and characteristics of data sources identified in Stage I (e.g., scope, accessibility, population coverage, variables collected) with insights gathered in Stage II about their practical use, availability, and limitations as described by the participants. In particular, we will assess whether data sources identified in literature are also recognised or used by key stakeholders in Flanders, and whether additional data sources are known to local actors but were reported in the literature. We will also compare reported legal and ethical considerations across both stages. This comparison will help to validate, expand, or challenge the findings from the literature and identify gaps between formal reporting and actual data access and usage practices in the field. The compared and contrasted outcomes of both studies will be presented and discussed with a research advisory group, to broaden the understanding of the outcomes and formulate recommendations for further research. Table 1 lists a summary of the different stages that will take place during the study and the respective methods for data collection.”

You should also add which kind of data will be collected from two groups of participants in 4.3. Then readers can clearly understand how these data from Stage I and II will be comparable.

We added the following to section 4.3:
“The interviews will collect two types of data. From data gatekeepers, we will collect information on the availability, accessibility, structure, content, and quality of existing data sources relevant to access to and use of medicines among migrants in Flanders, as well as legal, technical, and ethical considerations in using these data. From members of migrant communities, we will collect insights on whether and how their access to medicines may be represented (or overlooked) in existing data sources, including perceptions of data use, trust in institutions, and barriers to inclusion.”

4.2.1. Are community members only first generation migrants?
Thank you for raising this point. In the text we describe community members as migrants who have been living in Belgium for over 5 years and are active members of the community. These include individuals with migration background who are in leadership roles within community organizations and social clubs. This definition does not only apply to first-generation migrants but to all who identify as migrants.

4.2.3 Please briefly describe how will you approach the community members and data gatekeepers separately?
We added the following to section 4.2.3 to explain how we approached the data gatekeepers and community members:
“Data gatekeepers will primarily be approached through institutional networks, professional contacts, and health sector organizations. In contrast, community members will be approached via civil society organizations, community-based networks, and local NGOs working with migrant populations”

4.3. What about migrants who cannot speak Dutch or English? Will you include interpreters?
Thank you for pointing out the need for clarification. In this case we will include interpreters to ensure that migrants who do not speak Dutch or English can fully participate in the study.

4.4. Will you use deductive or inductive approach? If you use deductive approach, on which framework will you based the analysis on?
We are using an inductive approach to our analyses. We added the following to explain this point:
“We will follow an inductive approach to data analysis to ensure that findings emerge directly from the participants’ narratives and viewpoints, rather than being constrained by pre-existing frameworks or assumptions.”
Thank you for giving me opportunity to review this article. This protocol aims to map available data sources on migrants' access to medicines in Flanders, Belgium. I think this is a great effort and would have scientific impact. I have a few comments on the following topics.
We appreciate your thoughtful review of our protocol. Your comments and suggestions have been very helpful in improving our protocol. Below, we respond to all comments.

Abstract
1.Objective
This study is to map the available datasets about access to and use of medicines. I am wondering is it the prescription based medical access to OTC medication?
Thank you for this question. Both prescription based medication and OTC medication are of interest in this study.

2. Keywords
I think "access" is one of the keywords.
Thank you for this observation. We added “access” to the key words.

3. Introduction
1. I understand that data protection is important to protect the migrant population. It would be great if the introduction can add the following information.
1.a. How people access medicine in Belgium and other EU countries and why migrants can be left behind?
Thank you for this suggestion. We have added the following to address you suggestion:
“Access to essential medicines for migrants in Europe varies significantly across countries due to differences in healthcare systems, legal frameworks, and the socio-political status of migrants. Migrants, particularly asylum seekers, refugees, and undocumented migrants, often face substantial barriers to accessing medicines. These barriers include limited legal entitlements, financial constraints, language issues, and lack of familiarity with healthcare systems. In many EU countries, asylum seekers and undocumented migrants may be excluded from national health insurance systems or face long waiting periods for coverage, which can delay or restrict access to essential medications. In Belgium, asylum seekers are entitled to medical care under the "Aide Médicale Urgente" (AMU) system, which covers urgent and necessary healthcare, including some essential medicines. However, this provision often does not cover the full range of chronic disease treatments. While some NGOs and local health actors provide support to fill these gaps, persistent challenges remain, underscoring the need for more inclusive and coordinated policies and better data to ensure equitable access to medicines for all migrant populations.”

Methods
4.1.1. b. Do you mean literature published in English and Dutch? Why do you particularly choose these two languages but not others like German or French?
We focused on Dutch and English publications. Dutch is the official language of Flanders, making it the primary language for regional governmental and institutional reports. English was included due to its widespread use in academic publishing and its prominence in reports by international and non-governmental organizations. While French and German are also official languages in Belgium, it is less likely that literature specifically addressing migrants’ access to healthcare in Flanders would be published exclusively in those languages.

4.1.3. It would be great if you can describe more elaboratively on how the qualitative interviews be compared with the finding from Stage I. On which part and how?
We added the following to address your suggestion:
“To enable meaningful triangulation, we will compare the types and characteristics of data sources identified in Stage I (e.g., scope, accessibility, population coverage, variables collected) with insights gathered in Stage II about their practical use, availability, and limitations as described by the participants. In particular, we will assess whether data sources identified in literature are also recognised or used by key stakeholders in Flanders, and whether additional data sources are known to local actors but were reported in the literature. We will also compare reported legal and ethical considerations across both stages. This comparison will help to validate, expand, or challenge the findings from the literature and identify gaps between formal reporting and actual data access and usage practices in the field. The compared and contrasted outcomes of both studies will be presented and discussed with a research advisory group, to broaden the understanding of the outcomes and formulate recommendations for further research. Table 1 lists a summary of the different stages that will take place during the study and the respective methods for data collection.”

You should also add which kind of data will be collected from two groups of participants in 4.3. Then readers can clearly understand how these data from Stage I and II will be comparable.

We added the following to section 4.3:
“The interviews will collect two types of data. From data gatekeepers, we will collect information on the availability, accessibility, structure, content, and quality of existing data sources relevant to access to and use of medicines among migrants in Flanders, as well as legal, technical, and ethical considerations in using these data. From members of migrant communities, we will collect insights on whether and how their access to medicines may be represented (or overlooked) in existing data sources, including perceptions of data use, trust in institutions, and barriers to inclusion.”

4.2.1. Are community members only first generation migrants?
Thank you for raising this point. In the text we describe community members as migrants who have been living in Belgium for over 5 years and are active members of the community. These include individuals with migration background who are in leadership roles within community organizations and social clubs. This definition does not only apply to first-generation migrants but to all who identify as migrants.

4.2.3 Please briefly describe how will you approach the community members and data gatekeepers separately?
We added the following to section 4.2.3 to explain how we approached the data gatekeepers and community members:
“Data gatekeepers will primarily be approached through institutional networks, professional contacts, and health sector organizations. In contrast, community members will be approached via civil society organizations, community-based networks, and local NGOs working with migrant populations”

4.3. What about migrants who cannot speak Dutch or English? Will you include interpreters?
Thank you for pointing out the need for clarification. In this case we will include interpreters to ensure that migrants who do not speak Dutch or English can fully participate in the study.

4.4. Will you use deductive or inductive approach? If you use deductive approach, on which framework will you based the analysis on?
We are using an inductive approach to our analyses. We added the following to explain this point:
“We will follow an inductive approach to data analysis to ensure that findings emerge directly from the participants’ narratives and viewpoints, rather than being constrained by pre-existing frameworks or assumptions.”
Competing Interests: No competing interests were disclosed. Close
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COMMENTS ON THIS REPORT

Author Response 21 Mar 2025

Loes Meukens, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

21 Mar 2025

Author Response

Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide ... Continue reading Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide responses to your comments by mid-April.
Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide responses to your comments by mid-April.
Competing Interests: No competing interests were disclosed. Close
Report a concern
Author Response 08 Jul 2025

Loes Meukens, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

08 Jul 2025

Author Response

Thank you for giving me opportunity to review this article. This protocol aims to map available data sources on migrants' access to medicines in Flanders, Belgium. I think this is ... Continue reading Thank you for giving me opportunity to review this article. This protocol aims to map available data sources on migrants' access to medicines in Flanders, Belgium. I think this is a great effort and would have scientific impact. I have a few comments on the following topics.
We appreciate your thoughtful review of our protocol. Your comments and suggestions have been very helpful in improving our protocol. Below, we respond to all comments.

Abstract
1.Objective
This study is to map the available datasets about access to and use of medicines. I am wondering is it the prescription based medical access to OTC medication?
Thank you for this question. Both prescription based medication and OTC medication are of interest in this study.

2. Keywords
I think "access" is one of the keywords.
Thank you for this observation. We added “access” to the key words.

3. Introduction
1. I understand that data protection is important to protect the migrant population. It would be great if the introduction can add the following information.
1.a. How people access medicine in Belgium and other EU countries and why migrants can be left behind?
Thank you for this suggestion. We have added the following to address you suggestion:
“Access to essential medicines for migrants in Europe varies significantly across countries due to differences in healthcare systems, legal frameworks, and the socio-political status of migrants. Migrants, particularly asylum seekers, refugees, and undocumented migrants, often face substantial barriers to accessing medicines. These barriers include limited legal entitlements, financial constraints, language issues, and lack of familiarity with healthcare systems. In many EU countries, asylum seekers and undocumented migrants may be excluded from national health insurance systems or face long waiting periods for coverage, which can delay or restrict access to essential medications. In Belgium, asylum seekers are entitled to medical care under the "Aide Médicale Urgente" (AMU) system, which covers urgent and necessary healthcare, including some essential medicines. However, this provision often does not cover the full range of chronic disease treatments. While some NGOs and local health actors provide support to fill these gaps, persistent challenges remain, underscoring the need for more inclusive and coordinated policies and better data to ensure equitable access to medicines for all migrant populations.”

Methods
4.1.1. b. Do you mean literature published in English and Dutch? Why do you particularly choose these two languages but not others like German or French?
We focused on Dutch and English publications. Dutch is the official language of Flanders, making it the primary language for regional governmental and institutional reports. English was included due to its widespread use in academic publishing and its prominence in reports by international and non-governmental organizations. While French and German are also official languages in Belgium, it is less likely that literature specifically addressing migrants’ access to healthcare in Flanders would be published exclusively in those languages.

4.1.3. It would be great if you can describe more elaboratively on how the qualitative interviews be compared with the finding from Stage I. On which part and how?
We added the following to address your suggestion:
“To enable meaningful triangulation, we will compare the types and characteristics of data sources identified in Stage I (e.g., scope, accessibility, population coverage, variables collected) with insights gathered in Stage II about their practical use, availability, and limitations as described by the participants. In particular, we will assess whether data sources identified in literature are also recognised or used by key stakeholders in Flanders, and whether additional data sources are known to local actors but were reported in the literature. We will also compare reported legal and ethical considerations across both stages. This comparison will help to validate, expand, or challenge the findings from the literature and identify gaps between formal reporting and actual data access and usage practices in the field. The compared and contrasted outcomes of both studies will be presented and discussed with a research advisory group, to broaden the understanding of the outcomes and formulate recommendations for further research. Table 1 lists a summary of the different stages that will take place during the study and the respective methods for data collection.”

You should also add which kind of data will be collected from two groups of participants in 4.3. Then readers can clearly understand how these data from Stage I and II will be comparable.

We added the following to section 4.3:
“The interviews will collect two types of data. From data gatekeepers, we will collect information on the availability, accessibility, structure, content, and quality of existing data sources relevant to access to and use of medicines among migrants in Flanders, as well as legal, technical, and ethical considerations in using these data. From members of migrant communities, we will collect insights on whether and how their access to medicines may be represented (or overlooked) in existing data sources, including perceptions of data use, trust in institutions, and barriers to inclusion.”

4.2.1. Are community members only first generation migrants?
Thank you for raising this point. In the text we describe community members as migrants who have been living in Belgium for over 5 years and are active members of the community. These include individuals with migration background who are in leadership roles within community organizations and social clubs. This definition does not only apply to first-generation migrants but to all who identify as migrants.

4.2.3 Please briefly describe how will you approach the community members and data gatekeepers separately?
We added the following to section 4.2.3 to explain how we approached the data gatekeepers and community members:
“Data gatekeepers will primarily be approached through institutional networks, professional contacts, and health sector organizations. In contrast, community members will be approached via civil society organizations, community-based networks, and local NGOs working with migrant populations”

4.3. What about migrants who cannot speak Dutch or English? Will you include interpreters?
Thank you for pointing out the need for clarification. In this case we will include interpreters to ensure that migrants who do not speak Dutch or English can fully participate in the study.

4.4. Will you use deductive or inductive approach? If you use deductive approach, on which framework will you based the analysis on?
We are using an inductive approach to our analyses. We added the following to explain this point:
“We will follow an inductive approach to data analysis to ensure that findings emerge directly from the participants’ narratives and viewpoints, rather than being constrained by pre-existing frameworks or assumptions.”
Thank you for giving me opportunity to review this article. This protocol aims to map available data sources on migrants' access to medicines in Flanders, Belgium. I think this is a great effort and would have scientific impact. I have a few comments on the following topics.
We appreciate your thoughtful review of our protocol. Your comments and suggestions have been very helpful in improving our protocol. Below, we respond to all comments.

Abstract
1.Objective
This study is to map the available datasets about access to and use of medicines. I am wondering is it the prescription based medical access to OTC medication?
Thank you for this question. Both prescription based medication and OTC medication are of interest in this study.

2. Keywords
I think "access" is one of the keywords.
Thank you for this observation. We added “access” to the key words.

3. Introduction
1. I understand that data protection is important to protect the migrant population. It would be great if the introduction can add the following information.
1.a. How people access medicine in Belgium and other EU countries and why migrants can be left behind?
Thank you for this suggestion. We have added the following to address you suggestion:
“Access to essential medicines for migrants in Europe varies significantly across countries due to differences in healthcare systems, legal frameworks, and the socio-political status of migrants. Migrants, particularly asylum seekers, refugees, and undocumented migrants, often face substantial barriers to accessing medicines. These barriers include limited legal entitlements, financial constraints, language issues, and lack of familiarity with healthcare systems. In many EU countries, asylum seekers and undocumented migrants may be excluded from national health insurance systems or face long waiting periods for coverage, which can delay or restrict access to essential medications. In Belgium, asylum seekers are entitled to medical care under the "Aide Médicale Urgente" (AMU) system, which covers urgent and necessary healthcare, including some essential medicines. However, this provision often does not cover the full range of chronic disease treatments. While some NGOs and local health actors provide support to fill these gaps, persistent challenges remain, underscoring the need for more inclusive and coordinated policies and better data to ensure equitable access to medicines for all migrant populations.”

Methods
4.1.1. b. Do you mean literature published in English and Dutch? Why do you particularly choose these two languages but not others like German or French?
We focused on Dutch and English publications. Dutch is the official language of Flanders, making it the primary language for regional governmental and institutional reports. English was included due to its widespread use in academic publishing and its prominence in reports by international and non-governmental organizations. While French and German are also official languages in Belgium, it is less likely that literature specifically addressing migrants’ access to healthcare in Flanders would be published exclusively in those languages.

4.1.3. It would be great if you can describe more elaboratively on how the qualitative interviews be compared with the finding from Stage I. On which part and how?
We added the following to address your suggestion:
“To enable meaningful triangulation, we will compare the types and characteristics of data sources identified in Stage I (e.g., scope, accessibility, population coverage, variables collected) with insights gathered in Stage II about their practical use, availability, and limitations as described by the participants. In particular, we will assess whether data sources identified in literature are also recognised or used by key stakeholders in Flanders, and whether additional data sources are known to local actors but were reported in the literature. We will also compare reported legal and ethical considerations across both stages. This comparison will help to validate, expand, or challenge the findings from the literature and identify gaps between formal reporting and actual data access and usage practices in the field. The compared and contrasted outcomes of both studies will be presented and discussed with a research advisory group, to broaden the understanding of the outcomes and formulate recommendations for further research. Table 1 lists a summary of the different stages that will take place during the study and the respective methods for data collection.”

You should also add which kind of data will be collected from two groups of participants in 4.3. Then readers can clearly understand how these data from Stage I and II will be comparable.

We added the following to section 4.3:
“The interviews will collect two types of data. From data gatekeepers, we will collect information on the availability, accessibility, structure, content, and quality of existing data sources relevant to access to and use of medicines among migrants in Flanders, as well as legal, technical, and ethical considerations in using these data. From members of migrant communities, we will collect insights on whether and how their access to medicines may be represented (or overlooked) in existing data sources, including perceptions of data use, trust in institutions, and barriers to inclusion.”

4.2.1. Are community members only first generation migrants?
Thank you for raising this point. In the text we describe community members as migrants who have been living in Belgium for over 5 years and are active members of the community. These include individuals with migration background who are in leadership roles within community organizations and social clubs. This definition does not only apply to first-generation migrants but to all who identify as migrants.

4.2.3 Please briefly describe how will you approach the community members and data gatekeepers separately?
We added the following to section 4.2.3 to explain how we approached the data gatekeepers and community members:
“Data gatekeepers will primarily be approached through institutional networks, professional contacts, and health sector organizations. In contrast, community members will be approached via civil society organizations, community-based networks, and local NGOs working with migrant populations”

4.3. What about migrants who cannot speak Dutch or English? Will you include interpreters?
Thank you for pointing out the need for clarification. In this case we will include interpreters to ensure that migrants who do not speak Dutch or English can fully participate in the study.

4.4. Will you use deductive or inductive approach? If you use deductive approach, on which framework will you based the analysis on?
We are using an inductive approach to our analyses. We added the following to explain this point:
“We will follow an inductive approach to data analysis to ensure that findings emerge directly from the participants’ narratives and viewpoints, rather than being constrained by pre-existing frameworks or assumptions.”
Competing Interests: No competing interests were disclosed. Close
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Views

Reviewer Report 17 Feb 2025

Alejandro Gil-Salmerón, International Foundation for Integrated Care, Oxford, UK

Approved with Reservations

https://doi.org/10.5256/f1000research.176202.r366029

The study is presented in a timely manner to understand the medication access needs of immigrant people in Belgium.
In the first paragraph, it discusses health data and the migrant population at an international level. The last sentence needs theoretical support. The review conducted by Lebano et al. (2020) Migrants’ and refugees’ health status and healthcare in Europe: a scoping literature review concludes that the data is fragmented, making it difficult to reach conclusions due to the diversity of studies.
Regarding the review for mapping databases, I do not believe this is a research objective but rather a step in the process of conducting the research. In this sense, a research objective would be to study these databases by defining, for example, their size, quality, and the type of data collected. To achieve this, it will be necessary to map the databases following a rigorous scientific methodology (e.g., systematic review). The second objective would be ideal for covering both aspects.
Regarding interviews with key informants, we must consider that key informants are those who can provide key information from a specific perspective, but within qualitative research, they are not part of the study population. Therefore, the study population should be better defined as those who use these data and need access to them.

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

1. Lebano A, Hamed S, Bradby H, Gil-Salmerón A, et al.: Migrants' and refugees' health status and healthcare in Europe: a scoping literature review.BMC Public Health. 2020; 20 (1): 1039 PubMed Abstract | Publisher Full Text

Competing Interests: No competing interests were disclosed.

Reviewer Expertise: Access to healthcare, migration health, disadvatanged groups, integrated care, populations health

CITE

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Author Response 21 Mar 2025

Loes Meukens, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

21 Mar 2025

Author Response

Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide ... Continue reading Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide responses to your comments by mid-April.
Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide responses to your comments by mid-April.
Competing Interests: No competing interests were disclosed. Close
Report a concern
Author Response 24 Jun 2025

Loes Meukens, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

24 Jun 2025

Author Response

1. The study is presented in a timely manner to understand the medication access needs of immigrant people in Belgium.
Thank you for your positive feedback. Your comments and suggestions ... Continue reading 1. The study is presented in a timely manner to understand the medication access needs of immigrant people in Belgium.
Thank you for your positive feedback. Your comments and suggestions have been very helpful in improving our protocol. Please find below our point-by-point responses to your comments and suggestions.

2. In the first paragraph, it discusses health data and the migrant population at an international level. The last sentence needs theoretical support. The review conducted by Lebano et al. (2020) Migrants’ and refugees’ health status and healthcare in Europe: a scoping literature review concludes that the data is fragmented, making it difficult to reach conclusions due to the diversity of studies.
Thank you. We added the following to address your suggestion:

“However, the collection of such data remains fragmented across settings and time periods, often lacking standardised and shared procedures. This impedes efforts to monitor and improve migrant health in Europe. As Lebano et al. (2020) concluded in their scoping review, the lack of reliable and routine data collection, inconsistent definitions of migrant categories, and variations in national health systems all present major barriers to assessing and comparing health outcomes. While interest in migrants’ health is growing, these limitations create serious challenges in developing evidence-based policies and tailored healthcare interventions”

3. Regarding the review for mapping databases, I do not believe this is a research objective but rather a step in the process of conducting the research. In this sense, a research objective would be to study these databases by defining, for example, their size, quality, and the type of data collected. To achieve this, it will be necessary to map the databases following a rigorous scientific methodology (e.g., systematic review). The second objective would be ideal for covering both aspects.
Thank you for your suggestion. We have revised the section that lists the specific aims as follows:
“To study different quantitative and/or qualitative data sources that contain information on access to and use of medicines by defining their size, quality, and the type of data collected, and understand how they can be de-identified, curated, and assessed for accuracy, completeness and coherence, as well as comparability across datasets, for being used for M&E or research.”

4. Regarding interviews with key informants, we must consider that key informants are those who can provide key information from a specific perspective, but within qualitative research, they are not part of the study population. Therefore, the study population should be better defined as those who use these data and need access to them.
Thank you for your insightful comment. We appreciate your point about the distinction between key informants and the study population. We would like to clarify that, in the context of our study, the individuals we refer to as key informants are those responsible for the collection, management, and processing of datasets related to access to or use of medicine. These key informants are integral to answering our research questions. They will provide crucial information that directly aligns with our study's aims. While they are not the direct beneficiaries of the data, their role in providing the necessary insights makes them central to the study.
1. The study is presented in a timely manner to understand the medication access needs of immigrant people in Belgium.
Thank you for your positive feedback. Your comments and suggestions have been very helpful in improving our protocol. Please find below our point-by-point responses to your comments and suggestions.

2. In the first paragraph, it discusses health data and the migrant population at an international level. The last sentence needs theoretical support. The review conducted by Lebano et al. (2020) Migrants’ and refugees’ health status and healthcare in Europe: a scoping literature review concludes that the data is fragmented, making it difficult to reach conclusions due to the diversity of studies.
Thank you. We added the following to address your suggestion:

“However, the collection of such data remains fragmented across settings and time periods, often lacking standardised and shared procedures. This impedes efforts to monitor and improve migrant health in Europe. As Lebano et al. (2020) concluded in their scoping review, the lack of reliable and routine data collection, inconsistent definitions of migrant categories, and variations in national health systems all present major barriers to assessing and comparing health outcomes. While interest in migrants’ health is growing, these limitations create serious challenges in developing evidence-based policies and tailored healthcare interventions”

3. Regarding the review for mapping databases, I do not believe this is a research objective but rather a step in the process of conducting the research. In this sense, a research objective would be to study these databases by defining, for example, their size, quality, and the type of data collected. To achieve this, it will be necessary to map the databases following a rigorous scientific methodology (e.g., systematic review). The second objective would be ideal for covering both aspects.
Thank you for your suggestion. We have revised the section that lists the specific aims as follows:
“To study different quantitative and/or qualitative data sources that contain information on access to and use of medicines by defining their size, quality, and the type of data collected, and understand how they can be de-identified, curated, and assessed for accuracy, completeness and coherence, as well as comparability across datasets, for being used for M&E or research.”

4. Regarding interviews with key informants, we must consider that key informants are those who can provide key information from a specific perspective, but within qualitative research, they are not part of the study population. Therefore, the study population should be better defined as those who use these data and need access to them.
Thank you for your insightful comment. We appreciate your point about the distinction between key informants and the study population. We would like to clarify that, in the context of our study, the individuals we refer to as key informants are those responsible for the collection, management, and processing of datasets related to access to or use of medicine. These key informants are integral to answering our research questions. They will provide crucial information that directly aligns with our study's aims. While they are not the direct beneficiaries of the data, their role in providing the necessary insights makes them central to the study.
Competing Interests: No competing interests were disclosed. Close
Report a concern
Respond or Comment

COMMENTS ON THIS REPORT

Author Response 21 Mar 2025

Loes Meukens, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

21 Mar 2025

Author Response

Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide ... Continue reading Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide responses to your comments by mid-April.
Thank you for your positive feedback and constructive review. Your comments and suggestions are very helpful in improving our protocol. We appreciate your patience and will revise certain sections and provide responses to your comments by mid-April.
Competing Interests: No competing interests were disclosed. Close
Report a concern
Author Response 24 Jun 2025

Loes Meukens, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

24 Jun 2025

Author Response

1. The study is presented in a timely manner to understand the medication access needs of immigrant people in Belgium.
Thank you for your positive feedback. Your comments and suggestions ... Continue reading 1. The study is presented in a timely manner to understand the medication access needs of immigrant people in Belgium.
Thank you for your positive feedback. Your comments and suggestions have been very helpful in improving our protocol. Please find below our point-by-point responses to your comments and suggestions.

2. In the first paragraph, it discusses health data and the migrant population at an international level. The last sentence needs theoretical support. The review conducted by Lebano et al. (2020) Migrants’ and refugees’ health status and healthcare in Europe: a scoping literature review concludes that the data is fragmented, making it difficult to reach conclusions due to the diversity of studies.
Thank you. We added the following to address your suggestion:

“However, the collection of such data remains fragmented across settings and time periods, often lacking standardised and shared procedures. This impedes efforts to monitor and improve migrant health in Europe. As Lebano et al. (2020) concluded in their scoping review, the lack of reliable and routine data collection, inconsistent definitions of migrant categories, and variations in national health systems all present major barriers to assessing and comparing health outcomes. While interest in migrants’ health is growing, these limitations create serious challenges in developing evidence-based policies and tailored healthcare interventions”

3. Regarding the review for mapping databases, I do not believe this is a research objective but rather a step in the process of conducting the research. In this sense, a research objective would be to study these databases by defining, for example, their size, quality, and the type of data collected. To achieve this, it will be necessary to map the databases following a rigorous scientific methodology (e.g., systematic review). The second objective would be ideal for covering both aspects.
Thank you for your suggestion. We have revised the section that lists the specific aims as follows:
“To study different quantitative and/or qualitative data sources that contain information on access to and use of medicines by defining their size, quality, and the type of data collected, and understand how they can be de-identified, curated, and assessed for accuracy, completeness and coherence, as well as comparability across datasets, for being used for M&E or research.”

4. Regarding interviews with key informants, we must consider that key informants are those who can provide key information from a specific perspective, but within qualitative research, they are not part of the study population. Therefore, the study population should be better defined as those who use these data and need access to them.
Thank you for your insightful comment. We appreciate your point about the distinction between key informants and the study population. We would like to clarify that, in the context of our study, the individuals we refer to as key informants are those responsible for the collection, management, and processing of datasets related to access to or use of medicine. These key informants are integral to answering our research questions. They will provide crucial information that directly aligns with our study's aims. While they are not the direct beneficiaries of the data, their role in providing the necessary insights makes them central to the study.
1. The study is presented in a timely manner to understand the medication access needs of immigrant people in Belgium.
Thank you for your positive feedback. Your comments and suggestions have been very helpful in improving our protocol. Please find below our point-by-point responses to your comments and suggestions.

2. In the first paragraph, it discusses health data and the migrant population at an international level. The last sentence needs theoretical support. The review conducted by Lebano et al. (2020) Migrants’ and refugees’ health status and healthcare in Europe: a scoping literature review concludes that the data is fragmented, making it difficult to reach conclusions due to the diversity of studies.
Thank you. We added the following to address your suggestion:

“However, the collection of such data remains fragmented across settings and time periods, often lacking standardised and shared procedures. This impedes efforts to monitor and improve migrant health in Europe. As Lebano et al. (2020) concluded in their scoping review, the lack of reliable and routine data collection, inconsistent definitions of migrant categories, and variations in national health systems all present major barriers to assessing and comparing health outcomes. While interest in migrants’ health is growing, these limitations create serious challenges in developing evidence-based policies and tailored healthcare interventions”

3. Regarding the review for mapping databases, I do not believe this is a research objective but rather a step in the process of conducting the research. In this sense, a research objective would be to study these databases by defining, for example, their size, quality, and the type of data collected. To achieve this, it will be necessary to map the databases following a rigorous scientific methodology (e.g., systematic review). The second objective would be ideal for covering both aspects.
Thank you for your suggestion. We have revised the section that lists the specific aims as follows:
“To study different quantitative and/or qualitative data sources that contain information on access to and use of medicines by defining their size, quality, and the type of data collected, and understand how they can be de-identified, curated, and assessed for accuracy, completeness and coherence, as well as comparability across datasets, for being used for M&E or research.”

4. Regarding interviews with key informants, we must consider that key informants are those who can provide key information from a specific perspective, but within qualitative research, they are not part of the study population. Therefore, the study population should be better defined as those who use these data and need access to them.
Thank you for your insightful comment. We appreciate your point about the distinction between key informants and the study population. We would like to clarify that, in the context of our study, the individuals we refer to as key informants are those responsible for the collection, management, and processing of datasets related to access to or use of medicine. These key informants are integral to answering our research questions. They will provide crucial information that directly aligns with our study's aims. While they are not the direct beneficiaries of the data, their role in providing the necessary insights makes them central to the study.
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VERSION 2 PUBLISHED 06 Feb 2025

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Alejandro Gil-Salmerón, International Foundation for Integrated Care, Oxford, UK
Yu par Khin, Institute of Science Tokyo, Tokyo, Japan
Cheng Chow, The University of Texas at Austin, Austin, USA
Stein Monteiro, Toronto Metropolitan University, Toronto, Canada

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25 Jul 2025 | for Version 2

Stein Monteiro, Toronto Metropolitan University, Toronto, Ontario, Canada

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Approved With Reservations

1) There is a clear policy problem being addressed by this paper: the under utilization of migrant health data. I think this is an important problem to address but the paper has not shown that this is in fact a problem. Can the authors show that migrant data is being under utilized?

2) While what the WHO has said is a good guidepost, and this paper is written with that as the main motivating factor, I think the paper should try to show how mapping, understanding how deidentifying and curating, as well as identifying the methodological and ethical challenges will contribute to solving the problem of the underutilization of migrant health data. It might be obvious, but will be useful for the reader to see that in the Rationale.

3) This sentence is incomplete: "Before such data can be effectively used, ethical implications regarding data collection, deidentification, processing, storage, analysis, and dissemination."

4) How will the studies in the focused review be analyzed. Are you planning to do a comparison between Flanders and Brussels?

5) The triangulation process is understandable, although it could be made it a little clearer. However, it is not clear how the results from the triangulation will help the main objectives of the study.

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Economics, Migration Studies

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Reviewer Report

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25 Jul 2025 | for Version 2

Cheng Chow, The University of Texas at Austin, Austin, USA

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Approved

Thank you for the substantial revisions. The manuscript is now clearer and better aligned with the study objectives. The rationale for focusing on Flanders is stronger, and the ethical considerations are more thoroughly addressed.

A few brief suggestions for further improvement:
1) Specify whether qualitative data will be coded manually or with software.
2) Consider describing how diversity across migrant subgroups (e.g., asylum seekers vs. long-term residents) will be accounted for in recruitment.

These remaining issues are relatively minor and should be straightforward to address. Overall, this is a timely and much-needed contribution to the literature on migration health data infrastructure. Thank you again for your thoughtful work.

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Migration, Health

I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard.

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13 Views

05 Mar 2025 | for Version 1

Cheng Chow, The University of Texas at Austin, Austin, USA

13 Views Cite this report Responses(2)

Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

Partly
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Yes
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Migration, Health

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Responses (2)

Author Response

22 Jul 2025

Loes Meukens, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

Overall: The authors aimed to map existing datasets on access to and use of medicines among migrant populations in Flanders, Belgium, and assess their feasibility for use in research and monitoring. Given the lack of comprehensive migration health data in Europe, this study has the potential to provide valuable insights into existing data sources and their usability. However, there are several areas that require clarification and improvement, as outlined below.

1. Title
The title accurately reflects the study’s focus on mapping datasets but does not fully capture the nature of the study as an initiative rather than an empirical research project. The authors may consider clarifying this distinction to ensure consistency between the study design and its presentation.
We appreciate your feedback and your careful review of our manuscript. However, we respectfully disagree with the suggestion that the study is an initiative rather than an empirical research project. While Stage I involves a focused review of existing datasets, Stage II includes qualitative interviews. This empirical component involves the collection and analysis of primary data and thus qualifies the study as empirical research.

To avoid any potential misunderstanding, we have replaced the term “research initiative” with “research study” in the manuscript text where relevant, while retaining the original title, which we believe accurately reflects the aims of the study.

2. Background & Rationale
The background section is well-structured and provides a strong rationale for the study. However, there are some areas where additional clarification
Thank you for the positive feedback on the structure and rationale of the background section. Below are our replies to your suggestions about the various points that need clarification.

2.1. The introduction spends significant space discussing WHO’s framework on migration and health without directly linking it to the study’s objectives. While the WHO framework provides a relevant backdrop, the authors should ensure that its relevance is explicitly stated. Please consider reducing the length of the WHO framework discussion and making a more explicit connection between the framework and the need for data-driven policy in Belgium.
Thank you for your suggestion. We revised the text to clearly establish the connection between the WHO framework and the study’s focus on identifying and curating datasets that can inform data-driven policy and healthcare interventions for migrant populations in Belgium. You can find the revised text under section 1.2 Rationale.

2.2. The rationale for focusing on Flanders should be strengthened. While the manuscript mentions Belgium's lack of migrant health data, it would be helpful to explain why Flanders was chosen specifically rather than Belgium as a whole.

Thank you for your comment. We focused on Flanders specifically for pragmatic reasons. These include the language capacity of our research team, and the established network within Flanders, which is more concentrated in this region compared to other parts of Belgium. Expanding the study to include other regions would have introduced significant logistical challenges related to budget and time constraints, which could compromise the feasibility of the study. We acknowledge that this regional focus limits the generalizability of our findings to Belgium as a whole. However, we will clearly reflect on this limitation when discussing the outcomes of our study and outline the implications for future research in other regions of Belgium. We added the following to address your suggestion:
“We focused on Flanders due to pragmatic reasons related to the language capacity of our research team, and our established network in the region. Expanding to other regions of Belgium would have introduced logistical challenges, including language barriers, and increased costs and time constraints. We acknowledge that this regional focus limits the generalizability of our findings.”

3. Study objectives
3.1. While the objectives are well defined, the current objectives mix data mapping, feasibility assessment, and ethical considerations without clearly delineating these as separate but interrelated research components. I would question what sources exist for data mapping, can these sources be used for research for data feasibility, and what are the barriers and possible solutions for ethnical and legal challenges?
Thank you for your suggestion. We revised the description of the specific aims of our study to read:

“ A) Data mapping: This objective focuses on identifying existing datasets related to migrant medicine use in Flanders. We will assess the availability and coverage of these sources, considering whether they can be used for research and M&E purposes.

B) Feasibility Assessment: Our study will evaluate feasibility of applying the sources of data identified by this study in future research studies that aim at evaluating the access of/use of medicines among the diverse migrants population.

C) Ethical considerations: We will describe the challenges related to accessing and using these data, including ethical and legal challenges, and to develop and describe viable strategies and recommendations for deidentification, data curation and risk mitigation.”

3.2. Objective (b) mentions assessing datasets for accuracy, completeness, and coherence, but the methodology does not describe how these aspects will be evaluated. What criteria will be used to assess data completeness and accuracy? Will there be a scoring system or expert validation?

For the evaluation of accuracy, completeness, and coherence, we will conduct a focused review of the datasets used in reporting medicine use. This review will help identify any limitations or challenges within the data. We will then discuss these limitations in detail during the qualitative interviews with participants, allowing us to gather insights and validate the findings from the data sources. Through this process, we aim to assess the quality and reliability of the data from both a technical and a practical perspective.

4. Methods
4.1. The exclusion of non-English/non-Dutch sources should be justified. Could relevant data sources exist in French, German, or other languages?
Thank you for referring to this issue. As we addressed in our response to Reviewer 2 in Section 4.1.1, we focused on Dutch and English publications for this study. Dutch is the official language of Flanders and the primary language used in regional governmental and institutional reports. English was included due to its widespread use in academic publishing and its prominence in reports by international and non-governmental organizations. While French and German are also official languages in Belgium, it is less likely that literature specifically addressing migrants' access to healthcare in Flanders would be published exclusively in those languages.

4.2. Will non-peer-reviewed (grey literature) sources be weighted differently in the analysis?
Yes, we will include grey literature in our focused review. This is mentioned in section 4.1.1.

4.3. It is unclear how extracted data will be analyzed. Will the authors use a framework approach to categorize datasets?
We added the following under section “e. Data Extraction and Synthesis” to address your question:
“The data extracted of this focused review will be collated, summarized and reported in a manner that aligns with the aim of the focused review. We will conduct thematic analysis and present its outcomes in a narrative format.”

4.4. The description of data gatekeepers is somewhat vague. It is unclear whether they include public health officials, policymakers, or dataset managers.
We agree that further clarification could be helpful. In the revised text, we have now explicitly included representatives of public health offices or institutions among the data gatekeepers.

The recruitment of migrants does not specify whether different migrant groups (e.g., asylum seekers vs. economic migrants) will be considered. I believe the authors would agree with me that migration status, duration of study and many other factors significantly different across migrant groups.
As noted, our study focuses on migrants who have been living in Belgium for over five years and who are active members of the migrant community. This includes individuals with diverse migration backgrounds—such as former asylum seekers, refugees, or economic migrants—who are currently in leadership roles within community organizations or social groups. While we do not select participants based on their current legal status, we intentionally target those who are well-connected within the community and familiar with the challenges migrants face in accessing medicines. This approach allows us to gather informed insights while capturing a range of experiences across different migrant groups.

5. Data Collection & Analysis
5.1. Will interviews be coded manually or using qualitative analysis software (e.g., NVivo)?
Thank you for this question. The interviews will be coded manually, using Microsoft Word.

5.2. The GDPR compliance discussion is strong, but there is no mention of additional anonymization or security measures. Given the sensitivity of migrant health data, more emphasis on pseudonymization, encryption, and data storage security would be beneficial.
Thank you for your suggestion. We have expanded the manuscript as follows to include a more detailed explanation of the anonymization and data security measures that will be taken throughout the study:
“In the Stage I of the study, when performing the focused review, no personal data will be processed. For the Stage II, when conducting the interviews, the lawful ground for the processing of the participant personal data will be the written consent of the participant. The study will also be entered in the Institute of Tropical Medicine GDPR registry of personal data processing activities and the requirements are reviewed by the Data Protection Officer. All study data will be pseudonymized at the earliest convenience. Identifiers are retained at a separate and secure location, and deleted (full anonymization) after the study is published. Identifiable information in any audio or videocall recording will also be minimized to the extent possible.”

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Competing Interests

No competing interests were disclosed.

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Reviewer Report

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03 Mar 2025 | for Version 1

Yu par Khin, Institute of Science Tokyo, Tokyo, Japan

14 Views Cite this report Responses(2)

Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Yes
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Access to healthcare by migrant, Qualitative research, Systematic review

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Author Response

08 Jul 2025

Loes Meukens, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

Thank you for giving me opportunity to review this article. This protocol aims to map available data sources on migrants' access to medicines in Flanders, Belgium. I think this is a great effort and would have scientific impact. I have a few comments on the following topics.
We appreciate your thoughtful review of our protocol. Your comments and suggestions have been very helpful in improving our protocol. Below, we respond to all comments.

Abstract
1.Objective
This study is to map the available datasets about access to and use of medicines. I am wondering is it the prescription based medical access to OTC medication?
Thank you for this question. Both prescription based medication and OTC medication are of interest in this study.

2. Keywords
I think "access" is one of the keywords.
Thank you for this observation. We added “access” to the key words.

3. Introduction
1. I understand that data protection is important to protect the migrant population. It would be great if the introduction can add the following information.
1.a. How people access medicine in Belgium and other EU countries and why migrants can be left behind?
Thank you for this suggestion. We have added the following to address you suggestion:
“Access to essential medicines for migrants in Europe varies significantly across countries due to differences in healthcare systems, legal frameworks, and the socio-political status of migrants. Migrants, particularly asylum seekers, refugees, and undocumented migrants, often face substantial barriers to accessing medicines. These barriers include limited legal entitlements, financial constraints, language issues, and lack of familiarity with healthcare systems. In many EU countries, asylum seekers and undocumented migrants may be excluded from national health insurance systems or face long waiting periods for coverage, which can delay or restrict access to essential medications. In Belgium, asylum seekers are entitled to medical care under the "Aide Médicale Urgente" (AMU) system, which covers urgent and necessary healthcare, including some essential medicines. However, this provision often does not cover the full range of chronic disease treatments. While some NGOs and local health actors provide support to fill these gaps, persistent challenges remain, underscoring the need for more inclusive and coordinated policies and better data to ensure equitable access to medicines for all migrant populations.”

Methods
4.1.1. b. Do you mean literature published in English and Dutch? Why do you particularly choose these two languages but not others like German or French?
We focused on Dutch and English publications. Dutch is the official language of Flanders, making it the primary language for regional governmental and institutional reports. English was included due to its widespread use in academic publishing and its prominence in reports by international and non-governmental organizations. While French and German are also official languages in Belgium, it is less likely that literature specifically addressing migrants’ access to healthcare in Flanders would be published exclusively in those languages.

4.1.3. It would be great if you can describe more elaboratively on how the qualitative interviews be compared with the finding from Stage I. On which part and how?
We added the following to address your suggestion:
“To enable meaningful triangulation, we will compare the types and characteristics of data sources identified in Stage I (e.g., scope, accessibility, population coverage, variables collected) with insights gathered in Stage II about their practical use, availability, and limitations as described by the participants. In particular, we will assess whether data sources identified in literature are also recognised or used by key stakeholders in Flanders, and whether additional data sources are known to local actors but were reported in the literature. We will also compare reported legal and ethical considerations across both stages. This comparison will help to validate, expand, or challenge the findings from the literature and identify gaps between formal reporting and actual data access and usage practices in the field. The compared and contrasted outcomes of both studies will be presented and discussed with a research advisory group, to broaden the understanding of the outcomes and formulate recommendations for further research. Table 1 lists a summary of the different stages that will take place during the study and the respective methods for data collection.”

You should also add which kind of data will be collected from two groups of participants in 4.3. Then readers can clearly understand how these data from Stage I and II will be comparable.

We added the following to section 4.3:
“The interviews will collect two types of data. From data gatekeepers, we will collect information on the availability, accessibility, structure, content, and quality of existing data sources relevant to access to and use of medicines among migrants in Flanders, as well as legal, technical, and ethical considerations in using these data. From members of migrant communities, we will collect insights on whether and how their access to medicines may be represented (or overlooked) in existing data sources, including perceptions of data use, trust in institutions, and barriers to inclusion.”

4.2.1. Are community members only first generation migrants?
Thank you for raising this point. In the text we describe community members as migrants who have been living in Belgium for over 5 years and are active members of the community. These include individuals with migration background who are in leadership roles within community organizations and social clubs. This definition does not only apply to first-generation migrants but to all who identify as migrants.

4.2.3 Please briefly describe how will you approach the community members and data gatekeepers separately?
We added the following to section 4.2.3 to explain how we approached the data gatekeepers and community members:
“Data gatekeepers will primarily be approached through institutional networks, professional contacts, and health sector organizations. In contrast, community members will be approached via civil society organizations, community-based networks, and local NGOs working with migrant populations”

4.3. What about migrants who cannot speak Dutch or English? Will you include interpreters?
Thank you for pointing out the need for clarification. In this case we will include interpreters to ensure that migrants who do not speak Dutch or English can fully participate in the study.

4.4. Will you use deductive or inductive approach? If you use deductive approach, on which framework will you based the analysis on?
We are using an inductive approach to our analyses. We added the following to explain this point:
“We will follow an inductive approach to data analysis to ensure that findings emerge directly from the participants’ narratives and viewpoints, rather than being constrained by pre-existing frameworks or assumptions.”

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Competing Interests

No competing interests were disclosed.

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Reviewer Report

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17 Feb 2025 | for Version 1

Alejandro Gil-Salmerón, International Foundation for Integrated Care, Oxford, UK

12 Views Cite this report Responses(2)

Approved With Reservations

Is the rationale for, and objectives of, the study clearly described?

Yes
Is the study design appropriate for the research question?

Partly
Are sufficient details of the methods provided to allow replication by others?

Partly
Are the datasets clearly presented in a useable and accessible format?

Not applicable

References

Competing Interests

No competing interests were disclosed.

Reviewer Expertise

Access to healthcare, migration health, disadvatanged groups, integrated care, populations health

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Author Response

24 Jun 2025

Loes Meukens, Department of Public Health, Institute of Tropical Medicine, Antwerp, Belgium

1. The study is presented in a timely manner to understand the medication access needs of immigrant people in Belgium.
Thank you for your positive feedback. Your comments and suggestions have been very helpful in improving our protocol. Please find below our point-by-point responses to your comments and suggestions.

2. In the first paragraph, it discusses health data and the migrant population at an international level. The last sentence needs theoretical support. The review conducted by Lebano et al. (2020) Migrants’ and refugees’ health status and healthcare in Europe: a scoping literature review concludes that the data is fragmented, making it difficult to reach conclusions due to the diversity of studies.
Thank you. We added the following to address your suggestion:

“However, the collection of such data remains fragmented across settings and time periods, often lacking standardised and shared procedures. This impedes efforts to monitor and improve migrant health in Europe. As Lebano et al. (2020) concluded in their scoping review, the lack of reliable and routine data collection, inconsistent definitions of migrant categories, and variations in national health systems all present major barriers to assessing and comparing health outcomes. While interest in migrants’ health is growing, these limitations create serious challenges in developing evidence-based policies and tailored healthcare interventions”

3. Regarding the review for mapping databases, I do not believe this is a research objective but rather a step in the process of conducting the research. In this sense, a research objective would be to study these databases by defining, for example, their size, quality, and the type of data collected. To achieve this, it will be necessary to map the databases following a rigorous scientific methodology (e.g., systematic review). The second objective would be ideal for covering both aspects.
Thank you for your suggestion. We have revised the section that lists the specific aims as follows:
“To study different quantitative and/or qualitative data sources that contain information on access to and use of medicines by defining their size, quality, and the type of data collected, and understand how they can be de-identified, curated, and assessed for accuracy, completeness and coherence, as well as comparability across datasets, for being used for M&E or research.”

4. Regarding interviews with key informants, we must consider that key informants are those who can provide key information from a specific perspective, but within qualitative research, they are not part of the study population. Therefore, the study population should be better defined as those who use these data and need access to them.
Thank you for your insightful comment. We appreciate your point about the distinction between key informants and the study population. We would like to clarify that, in the context of our study, the individuals we refer to as key informants are those responsible for the collection, management, and processing of datasets related to access to or use of medicine. These key informants are integral to answering our research questions. They will provide crucial information that directly aligns with our study's aims. While they are not the direct beneficiaries of the data, their role in providing the necessary insights makes them central to the study.

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Competing Interests

No competing interests were disclosed.

Alongside their report, reviewers assign a status to the article:

Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested

Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.

Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions

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Mapping data on access to and use of medicines among migrants in Flanders

Abstract

Background

Objective

Methods

Results

Keywords

1. Introduction

1.1 Background

1.2 Rationale

2. Study objectives

3. Study design

Figure 1. The overall sequential design of the research study, fractionated in three stages.

4. Methods

4.1 Procedures

Table 1. Summary of project research objectives, questions, methods and logical sequence across the project stages.

4.2 Study population

4.3 Data collection

4.4 Qualitative data analysis

5. Results

Authors’ contributions

Ethics review

Data availability statement

Extended data

Acknowledgements

References

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