Evidence map›Paper›PMID 35275228›Full record

ArticleUnfallchirurgie (Heidelberg, Germany)2023

[Influence of the general data protection regulation on data quality in registry data collection : Selection bias due to data protection requirements and the impact on key indicators for measuring the quality of care in a level 1 trauma center].

Orkun Özkurtul, N von Dercks, C Fuchs, A Keß, G Osterhoff, M F Struck, A Scholtz, C Josten, J K M Fakler

Open access · hybridAbstract readEnglish Abstract
In one paragraph

Article in Unfallchirurgie (Heidelberg, Germany), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.3field-weighted citation impact, top 47% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 1 citations in OpenAlex.

  1. Review
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 2 institutions in 1 country.

Orkun ÖzkurtulKlinik und Poliklinik für Orthopädie, Unfallchirurgie und Plastische Chirurgie, Universitätsklinikum Leipzig AöR, Liebigstr. 24, 04103, Leipzig, Deutschland. oezkurtul@medizin.uni-leipzig.de.
N von DercksKlinik und Poliklinik für Orthopädie, Unfallchirurgie und Plastische Chirurgie, Universitätsklinikum Leipzig AöR, Liebigstr. 24, 04103, Leipzig, Deutschland.
C FuchsKlinik und Poliklinik für Orthopädie, Unfallchirurgie und Plastische Chirurgie, Universitätsklinikum Leipzig AöR, Liebigstr. 24, 04103, Leipzig, Deutschland.
A KeßKlinik und Poliklinik für Orthopädie, Unfallchirurgie und Plastische Chirurgie, Universitätsklinikum Leipzig AöR, Liebigstr. 24, 04103, Leipzig, Deutschland.
G OsterhoffKlinik und Poliklinik für Orthopädie, Unfallchirurgie und Plastische Chirurgie, Universitätsklinikum Leipzig AöR, Liebigstr. 24, 04103, Leipzig, Deutschland.
M F StruckKlinik und Poliklinik für Anästhesiologie und Intensivmedizin, Universitätsklinikum Leipzig AöR, Liebigstr. 24, 04103, Leipzig, Deutschland.
A ScholtzStabsstelle Datenschutz, Universitätsklinikum Leipzig AöR, Liebigstr. 20, 04103, Leipzig, Deutschland.
C JostenKlinik und Poliklinik für Orthopädie, Unfallchirurgie und Plastische Chirurgie, Universitätsklinikum Leipzig AöR, Liebigstr. 24, 04103, Leipzig, Deutschland.
J K M FaklerKlinik für Unfall-, Hand-, Wiederherstellungs- und Wirbelsäulenchirurgie, Klinikum Passau, Passau, Deutschland.
University Hospital Leipzig · DEKlinikum Passau · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDue to the new general data protection regulations (GDPR), the requirements for correct patient information on the documentation of pseudonymized data in a registry have increased enormously. In particular, written consent applies to the TraumaRegister DGU® as it is not always possible to get written permission from severely injured patients in acute situations. Therefore, the study aimed to investigate the influence of undocumented cases due to a lack of clarification on the standardized mortality rate (SMR). MATERIAL AND

methodsIn 2019, 274 patients meeting the criteria of the baseline dataset were retrospectively recorded. In the remaining 197 patients, the RISC II score could be calculated in all cases. In addition, due to state-specific law, all deceased patients were documented in our trauma center.

resultsIn this study with 197 primary care patients (72% male), 147 (74,6%) were informed and gave permission or died and were subsequently documented. The predicted mortality, actual mortality and SMR were 18.5%, 19.0% and 1.03, respectively. For patients who were not informed (n = 50), the predicted mortality, actual mortality, and SMR were 7.0%, 0% and 0. When these cases are included, the SMR is significantly more favorable at 0.93.

conclusionDue to the lack of written consent from surviving patients, only about 75% of all patients at Leipzig University Hospital could be documented for the TraumaRegister DGU®. On the other hand, since the local legal situation permits registry documentation of deceased patients, this has a detrimental effect on the standardized mortality rate (SMR), which is about 10% higher in our collective than it actually is.

Indexed as

Data AccuracyTrauma CentersFemaleHumansMaleRegistriesRetrospective StudiesSelection BiasData safetyInformed consentPatient careQuality indicatorsRegistry research

Identifiers

PMID35275228
PMCPMC10060278
OpenAlexW4221022525

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.