Artikel
Gender mismatch in the very old. Limitations induced by upper age limits in randomized intracerebral hemorrhage trials
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Autoren
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Marco Stein
- Klinik für Neurochirurgie, Universitätsklinikum Gießen, Justus Liebig Universität Gießen
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Björn Misselwitz
- Geschäftsstelle Qualitätssicherung Hessen (GQH), Eschborn
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Eberhard Uhl
- Klinik für Neurochirurgie, Universitätsklinikum Gießen, Justus Liebig Universität Gießen
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Marcus H. T. Reinges
- Klinik für Neurochirurgie, Universitätsklinikum Gießen, Justus Liebig Universität Gießen
| Veröffentlicht: | 2. Juni 2015 |
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Gliederung
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Objective: Hemorrhagic stroke is one of the leading causes of death worldwide. The differences of life expectancy between men and women lead to a higher proportion of women in the very old. This results in a higher rate of women in older patients with intracerebral hemorrhage. In recent randomized trials (MISTIE I, II, and III, etc.) upper age limits are part of the inclusion criteria or the very old were excluded by other criteria (STICH I, and II). This study was performed in order to evaluate how upper age limits effect the inclusion of men and women in intracerebral hemorrhage trials.
Method: For the analysis of upper age limits a prospective hospital-based stroke registry of the entire State of Hesse, Germany, was used. Only patients with the diagnosis of ICH were included (ICD-10: I61.0 to I61.9) who were admitted between January 2010 and December 2012. Gender differences were calculated at different cutoff points (70, 80, and 90 years) and the proportion of gender specific excluded patients was calculated.
Results: Overall, 5184 patients with the diagnosis of spontaneous ICH were identified. 2457 (47.4%) patients were woman and 2727 (52.6%) patients were man. Mean age was 72.3 ± 13.6 years. Female patients were significantly older compared to male patients (74.9 ± 13.5 years vs. 69.9 ± 13.2 years; p<0.001).
With an upper age limit of 70 years 1531 (56.1%) of the male patients and 1773 (72.2%) of the female patients with ICH were excluded from the analysis (p<0.001). An age cutoff of 80 years leads to an exclusion of 591 (21.7%) of the male patients and 979 (39.8%) of the female patients (p<0.001). In contrast, an age cutoff of 90 years results only in an exclusion of 45 (1.7%) of the male patients and 141 (5.7) of the female patients (p<0.001).
Conclusions: Upper age limits in trial of spontaneous intracerebral hemorrhage result in a significant gender imbalance and lead to the exclusion of a major part of the patients from these studies. This fact should be noted when data from such trials are transferred to clinical practice.
