Evidence map›Paper›PMID 27881523›Full record

Trial reportBMJ open2016

Effects of culture-sensitive adaptation of patient information material on usefulness in migrants: a multicentre, blinded randomised controlled trial.

Lars P Hölzel, Zivile Ries, Levente Kriston, Jörg Dirmaier, Jördis M Zill, Christine Rummel-Kluge, Wilhelm Niebling, Isaac Bermejo, Martin Härter

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03483168 (The Effects of Culturally Sensitive Pain Education Program in Turkish Patients With Chronic Low Back Pain), which is not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
5.8field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03483168 nacompletednot on this mapstarted 2018, after this paper: background citation

The Effects of Culturally Sensitive Pain Education Program in Turkish Patients With Chronic Low Back Pain: A Pilot Randomized Controlled Trial

TypeinterventionalSponsorHacettepe UniversityRan2018 to 2018Enrolled29ConditionsChronic Low Back PainArmsCulturally sensitive pain education, Standard pain education program
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.

  1. Interventions for improving health literacy in migrants.The Cochrane database of systematic reviews · 2023
    Pooled it
  2. The Cleft Lip Education with Augmented Reality (CLEAR) VR Phase 2 Trial: A Pilot Randomized Crossover Trial of a Novel Patient Information Leaflet.The Cleft palate-craniofacial journal : official publication of the American Cleft Palate-Craniofacial Association · 2023
    Trial
  3. Review
  4. Article
  5. Cultural tailoring of pain management approaches: a scoping review.International journal for equity in health · 2025
    Article
  6. Article
  7. Review
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Diversity Competency and Access to Healthcare in Hospitals in Croatia, Germany, Poland, and Slovenia.International journal of environmental research and public health · 2021
    Article
  15. A Multilingual Integrative Review of Health Literacy in Former Soviet Union, Russian-Speaking Immigrants.International journal of environmental research and public health · 2021
    Review
  16. Article
  17. Article
  18. Article
  19. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

9 authors at 5 institutions in 1 country.

Lars P HölzelDepartment of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Freiburg, Germany.
Zivile RiesDepartment of Psychiatry and Psychotherapy, Medical Center-University of Freiburg, Freiburg, Germany.
Levente KristonDepartment of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Jörg DirmaierDepartment of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Jördis M ZillDepartment of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Christine Rummel-KlugeDepartment of Psychiatry and Psychotherapy, University of Leipzig, Leipzig, Germany.
Wilhelm NieblingDepartment of General Practice, Medical Center-University of Freiburg, Freiburg, Germany.
Isaac BermejoStaff Unit Board of Directors, Medical Center-University of Freiburg, Freiburg, Germany.
Martin HärterDepartment of Medical Psychology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Universität Hamburg · DEUniversity Medical Center Freiburg · DEUniversity of Freiburg · DEEuropean Alliance Against Depression · DEUniversity Medical Center Hamburg-Eppendorf · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo evaluate the usefulness of culture-sensitive patient information material compared with standard translated material.

designMulticentre, double-blind randomised controlled trial.

setting37 primary care practices.

participants435 adult primary care patients with a migration background with unipolar depressive disorder or non-specific chronic low back pain were randomised. Patients who were unable to read in the language of their respective migration background were excluded. Sufficient data were obtained from 203 women and 106 men. The largest group was of Russian origin (202 patients), followed by those of Turkish (52), Polish (30) and Italian (25) origin.

interventionsIntervention group: provision of culture-sensitive adapted material. CONTROL GROUP: provision of standard translated material.

main outcome measuresPrimary outcome: patient-rated usefulness (USE) assessed immediately after patients received the material. SECONDARY OUTCOMES: patient-rated usefulness after 8 weeks and 6 months, symptoms of depression (PHQ-9), back pain (Back Pain Core Set) and quality of life (WHO-5) assessed at all time points.

resultsUsefulness was found to be significantly higher (t=1.708, one-sided p=0.04) in the intervention group (USE-score=65.08, SE=1.43), compared with the control group (61.43, SE=1.63), immediately after patients received the material, in the intention-to-treat analysis, with a mean difference of 3.65 (one-sided 95% lower confidence limit=0.13). No significant differences were found for usefulness at follow-up (p=0.16, p=0.71). No significant effect was found for symptom severity in depression (p=0.95, p=0.66, p=0.58), back pain (p=0.40, p=0.45, p=0.32) or quality of life (p=0.76, p=0.86, p=0.21), either immediately after receiving the material, or at follow-up (8 weeks; 6 months). Patients with a lower level of dominant society immersion benefited substantially and significantly more from the intervention than patients with a high level of immersion (p=0.005).

conclusionCultural adaptation of patient information material provides benefits over high quality translations. Clinicians are encouraged to use culture-sensitive material in their consultations, particularly with low-acculturated patients. TRIAL REGISTRATION NUMBER: German Register for Clinical Trials: DRKS00004241, Universal Trial Number: U1111-1135-8043, Results.

Indexed as

Cultural CompetencyPamphletsTransients and MigrantsAdultAgedDouble-Blind MethodFemaleFocus GroupsHealth LiteracyHumansItalyLanguageLow Back PainMajor Depressive DisorderMaleMiddle Agedculture sensitivedepressionlow back painmigrantspatient informationrandomized

Identifiers

PMID27881523
PMCPMC5168496
OpenAlexW2552094804

What OpenQuestion holds

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LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.