Reporting ethical approval in health and social science articles: an audit of adherence to GDPR and national legislation.

BACKGROUND: Previous studies have indicated that failure to report ethical approval is common in health science articles. In social sciences, the occurrence is unknown. The Swedish Ethics Review Act requests that sensitive personal data, in accordance with the EU General Data Protection Regulation (GDPR), should undergo independent ethical review, irrespective of academic discipline. We have explored the adherence to this regulation. METHODS: Using the Web of Science databases, we reviewed 600 consecutive articles from three domains (health sciences with and without somatic focus and social sciences) based on identifiable personal data published in 2020. RESULTS: Information on ethical review was lacking in 12 of 200 health science articles with somatic focus (6%), 21 of 200 health science articles with non-somatic focus (11%), and in 54 of 200 social science articles (27%; p < 0.001 vs. both groups of health science articles). Failure to report on ethical approval was more common in (a) observational than in interventional studies (p < 0.01), (b) articles with only 1-2 authors (p < 0.001) and (c) health science articles from universities without a medical school (p < 0.001). There was no significant association between journal impact factor and failure to report ethical approval. CONCLUSIONS: We conclude that reporting of research ethics approval is reasonably good, but not strict, in health science articles. Failure to report ethical approval is about three times more frequent in social sciences compared to health sciences. Improved adherence seems needed particularly in observational studies, in articles with few authors and in social science research.

Reporting Ethics Approval in Articles on Criminality. An Audit of Adherence to Swedish Legislation.

According to the Swedish Ethics Review Act, research involving personal data on crimes should undergo independent ethics review. To explore the reporting of ethics approval, we extracted information from articles with Swedish personal data on crimes published in 2013-2021. Of the identified 298 articles, 92 (31%) failed to report ethics approval. Failures were particularly common in articles with a qualitative design, single or few authors and when there was a social science focus. Failures varied markedly between universities. We conclude that failures to report compulsory ethics approval are common in articles involving personal data on crime and that these failures vary markedly with the research setting. Several indicators of poor adherence to the Ethics Review Act have been identified.

Discarding heparins as treatment for progressive stroke in Sweden 2001 to 2008.

BACKGROUND AND PURPOSE: High-dose heparin has been used extensively to treat patients with progressive ischemic stroke, but the scientific support is poor and the current stroke guidelines advise against its use. We studied how heparin treatment for progressive stroke has been discarded in Sweden. METHODS: All 78 hospitals in Sweden that admit acute stroke patients participate in Riks-Stroke, the Swedish Stroke Register. During 2001 to 2008, information on the use of high-dose heparin was available for 155,344 patients with acute ischemic stroke. The determinants as to region, patient characteristics, and stroke service settings were analyzed. RESULTS: Use of heparin for progressive stroke declined from 7.5% (2001) to 1.6% (2008) of all patients with ischemic stroke. The marked regional differences present in 2001 were reduced over time. The use of heparin declined at a similar rate in all types of hospital settings, in stroke units vs nonstroke units, and in neurological vs medical wards. Independent predictors of use of heparin included younger age, first-ever stroke, independence in activities of daily living before stroke, atrial fibrillation, no aspirin treatment, and lowered consciousness on admission. CONCLUSIONS: There is no immediate, stepwise effect of new scientific information and national guidelines on clinical practice. Rather, the phasing out of heparin has followed a linear course over several years, with less variation between hospitals. We speculate that open comparisons between hospitals in a national stroke register may have helped to reduce the variations in clinical practice.

Sex differences in management and outcome after stroke: a Swedish national perspective.

BACKGROUND AND PURPOSE: It is disputed whether there are sex differences in management and outcome after stroke; early studies have shown inconsistent results. The objective of this study was to verify and explain differences between men and women in management and outcome after stroke in a national perspective. METHODS: In 2001, 20 761 stroke patients were registered in Riks-Stroke, the national quality register for stroke care in Sweden in which all 84 hospitals participate. Data from 9 hospitals that had reported <70% of the estimated stroke events were excluded from analyses, leaving 19 547 patients (9666 women, 9881 men) at 75 hospitals for the present analyses. RESULTS: Women were older than men (77.8 versus 73.2 years). After age adjustment, female patients were more often disabled, living at home with community support, or in institutions before the stroke. They also had a different cardiovascular risk factor profile. Case fatality ratios during the first 3 months were similar in men and women. After 3 months, more women were physically and mentally impaired and dependent on other persons. Female patients with atrial fibrillation received oral anticoagulants less often than men. Even after multiple adjustments for differences between sexes, female sex was independently associated with institutional living 3 months after the stroke (odds ratio, 1.2; 95% confidence interval, 1.0 to 1.4). CONCLUSIONS: Women have a worse prestroke condition. Except for case fatality ratios, they also have a worse outcome after stroke after adjustment for other prognostic factors. There are also sex differences in the medical management of stroke that need to be rectified.

The Riks-Stroke story: building a sustainable national register for quality assessment of stroke care.

BACKGROUND: Riks-Stroke, the Swedish Stroke Register, is the world's longest-running national stroke quality register (established in 1994) and includes all 76 hospitals in Sweden admitting acute stroke patients. The development and maintenance of this sustainable national register is described. METHODS: Riks-Stroke includes information on the quality of care during the acute phase, rehabilitation and secondary prevention of stroke, as well as data on community support. Riks-Stroke is unique among stroke quality registers in that patients are followed during the first year after stroke. The data collected describe processes, and medical and patient-reported outcome measurements. The register embraces most of the dimensions of health-care quality (evidence-based, safe, provided in time, distributed fairly and patient oriented). RESULT: Annually, approximately 25,000 patients are included. In 2009, approximately 320,000 patients had been accumulated (mean age 76-years). The register is estimated to cover 82% of all stroke patients treated in Swedish hospitals. Among critical issues when building a national stroke quality register, the delicate balance between simplicity and comprehensiveness is emphasised. Future developments include direct transfer of data from digital medical records to Riks-Stroke and comprehensive strategies to use the information collected to rapidly implement new evidence-based techniques and to eliminate outdated methods in stroke care. CONCLUSIONS: It is possible to establish a sustainable quality register for stroke at the national level covering all hospitals admitting acute stroke patients. Riks-Stroke is fulfilling its main goals to support continuous quality improvement of Swedish stroke services and serve as an instrument for following up national stroke guidelines.

Riks-stroke - a Swedish national quality register for stroke care.

BACKGROUND: Riks-Stroke, the Swedish national quality register on stroke care, provides unique opportunities to evaluate stroke units in routine clinical care. METHODS: Basic patient characteristics, process indicators and outcome variables are recorded in all 85 hospitals admitting acute stroke patients. A 3-month follow-up is included. RESULTS: There are wide variations between hospitals in the proportion of patients admitted to a stroke unit, in secondary prevention and in the proportion of patients in institutional care at 3 months. Even after adjustment for available prognostic indicators, case fatality is lower and functional outcome is better in patients treated in stroke units than in patients treated in general wards. CONCLUSION: Riks-Stroke shows that outcome is consistently better in patients treated in a stroke unit than in general wards, not only in randomised trials but also in routine stroke care.