Representation of patients with a migration background in studies on antithrombotic treatment. An analysis of recruitment data from a cluster randomized controlled trial
Open accessAbstract
BACKGROUND: The health status, health awareness and health behavior of persons with a migration background often differ from the autochthonous population. Little is known about the proportion of patients with a migration background (PMB) that participate in primary care studies on oral antithrombotic treatment (OAT) in Germany, and whether the quality of their antithrombotic care differs from patients without a migration background. The aim of this paper was to use the results of a cluster-randomized controlled trial (PICANT) to determine the proportion of PMB at different stages of recruitment, and to compare the results in terms of sociodemographic characteristics and antithrombotic treatment. METHODS: This study used screening and baseline data from the PICANT trial on oral anticoagulation management in GP practices. For this analysis, we determined the proportion of PMB during the recruitment period at stage 1 (screening of potentially eligible patients), stage 2 (eligible patients invited to participate in the trial), and stage 3 (assessment of baseline characteristics of patients participating in the PICANT trial). In addition, we compared patients in terms of sociodemographic characteristics and quality of anticoagulant treatment. Statistical analysis comprised descriptive and bivariate analyses. RESULTS: The proportion of PMB at each recruitment stage declined from 9.1% at stage 1 to 7.9% at stage 2 and 7.3% at stage 3). A lack of German language skills led to the exclusion of half the otherwise eligible PMB. At stages 1 and 3, PMB were younger (stage 1: 70.7 vs. 75.0 years, p<0.001; stage 3: 70.2 vs. 73.5 years, p = 0.013), but did not differ in terms of gender. The quality of their anticoagulant care was comparable (100.0% vs. 99.1% were receiving appropriate OAT, 94.4% vs. 95.7% took phenprocoumon, or warfarin, and the most recent INR measurement of 60.8% vs. 69.3% was within their individual INR range). CONCLUSIONS: In the potentially eligible population and among participants at baseline, the quality of anticoagulant care was high in all groups of patients, which is reassuring. To enable the inclusion of more PMB, future primary care research on OAT in Germany should address how best to overcome language barriers. This will be challenging, particularly because the heterogeneity of PMB means the resulting sample sizes for each specific language group are small. TRIAL REGISTRATION: Current Controlled Trials ISRCTN41847489.
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Present-day challenges such as language barriers, cultural differences and a lack of cultural competence can make it difficult for researchers to rebuild trust and establish clear communication with potential participants.
“Beyond these historical issues, present-day challenges such as language barriers, cultural differences and a lack of cultural competence can make it difficult for researchers to effectively rebuild trust and establish clear communication with potential participants [14–17].”
From Enablers and barriers of clinical trial participation in adult patients from minority ethnic groups: a systematic review (2025) · cites this paper as [16]
The Discussion reports that lack of German language skills excluded many otherwise eligible patients and recommends interpreters or translated questionnaires, supporting the language-barrier and communication aspects. The Introduction recommends culturally diverse research staff, but the paper does not establish that cultural differences or a lack of cultural competence impede researchers’ efforts to rebuild trust. (LLM, conf=0.86)
Experimental — accuracy not yet measuredIn a German study, a correlation emerged between the trial phase and the migration status of participants; the proportion of migrant patients declined at each subsequent recruitment stage, indicating that patients with a migrant status were more likely to withdraw from trials.
“Finally, in a German study, a correlation emerged between the trial phase and the migration status of participants. The proportion of migrant patients declined at each subsequent recruitment stage, indicating that patients with a migrant status were more likely to withdraw from trials [16].”
From Enablers and barriers of clinical trial participation in adult patients from minority ethnic groups: a systematic review (2025) · cites this paper as [16]
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Experimental — accuracy not yet measuredIn a German study, 8.5% of eligible patients who declined participation had a migrant background, with 20% of these patients citing a lack of German language skills as the reason for declining.
“Meanwhile, in a German study, 8.5% of eligible patients who declined participation had a migrant background, with 20% of these patients citing a lack of German language skills as the reason for declining [16].”
From Enablers and barriers of clinical trial participation in adult patients from minority ethnic groups: a systematic review (2025) · cites this paper as [16]
The topic of patients withdrawing from clinical trials was scarcely discussed in the reviewed papers; only 4 studies explored this issue in African American and migrant groups.
“The topic of patients withdrawing from clinical trials was scarcely discussed in the reviewed papers; only 4 studies explored this issue in African American and migrant groups [16, 34, 40, 46].”
From Enablers and barriers of clinical trial participation in adult patients from minority ethnic groups: a systematic review (2025) · cites this paper as [16]
The Materials and methods (Data collection) and Results (Reasons for non-participation of eligible patients) sections examine whether invited patients joined the trial and why some did not. They do not address patients withdrawing after enrollment. The paper also does not establish the citing document’s count of four studies; searches for withdrawal and dropout found no decisive passage. (LLM, conf=0.77)
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References 24 · Cited by 3
- Authors
- Mergenthal, K., Siebenhofer, A., Ulrich, L.-R., Guethlin, C., Gerlach, F. M., & Petersen, J. J.
- Affiliations
- Goethe University Frankfurt (DE)
- Corresponding author
- Siebenhofer, Andrea
- Venue
- PLOS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2020-03-16
- Volume
- 15
- Issue
- 3
- Pages
- e0230297
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC7075549
- OpenAlex
- W3011034724
- Cited by
- 3
- References
- 24
- Citations by year
- 2025: 3
- FWCI
- 0.00
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS ONE (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Publication Server of Goethe University Frankfurt am Main (Goethe University Frankfurt) (submittedVersion, cc-by)
- Funders
- Bundesministerium für Bildung und Forschung (16PGF0036)
- Topics
- Social Sciences › Sociology and Political Science › Migration, Identity, and Health
- Social Sciences › Psychology › Clinical Psychology › Migration, Health and Trauma
- Social Sciences › Sociology and Political Science › Cultural Competency in Health Care
- Keywords
- anticoagulation, clinical trial participation, language barriers, phenprocoumon, warfarin, INR monitoring, primary care research, ethnic minorities, sociodemographic factors, health disparities, Germany, trial exclusion criteria
- MeSH terms
- Aged, Anticoagulants, Demography, Female, Fibrinolytic Agents, Humans, Male, Patient Selection, Human Migration
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