Reporting of ethical approval and informed consent in clinical research published in leading nursing journals : a retrospective observational study

Background: Ethical considerations play a prominent role in the protection of human subjects in clinical research. To date the disclosure of ethical protection in clinical research published in the international nursing journals has not been explored. Our research objective was to investigate the reporting of ethical approval and informed consent in clinical research published in leading international nursing journals. Methods: This is a retrospective observational study. All clinical research published in the five leading international nursing journals from the SCI Journal Citation Reports between 2015 and 2017 were retrieved to evaluate for evidence of ethical review. Results: A total of 2041 citations have been identified from the contents of all the five leading nursing journals that were published between 2015 and 2017. Out of these, 1284 clinical studies have been included and text relating to ethical review has been extracted. From these, most of prospective clinical studies (87.5%) discussed informed consent. Only half of those (52.9%) reported that written informed consent had been obtained; few (3.6%) reported oral consent, and few (6.8%) used other methods such as online consent or completion and return of data collection (such as surveys) to denote assent. Notably, 36.2% of those did not describe the method used to obtain informed consent and merely described that “consent was obtained from participants or participants agreed to join in the research”. Furthermore, whilst most of clinical studies (93.7%) mentioned ethical approval; 92.5% of those stated the name of ethical committee and interestingly, only 37.1% of those mentioned the ethical approval reference. The rates of reporting ethical approval were different between different study type, country, and whether financial support was received (all P<0.05). Conclusion: The reporting of ethics in leading international nursing journals demonstrates progress, but improvement of the transparency and the standard of ethical reporting in nursing clinical research is required

Health workers’ experience of providing second-trimester abortion care in Ethiopia: a qualitative study

Abstract Background Second-trimester abortions are less common than abortions in the first trimester, yet they disproportionately account for a higher burden of abortion-related mortality and morbidity worldwide. Health workers play a crucial role in granting or denying access to these services, yet little is known about their experiences. Ethiopia has been successful in reducing mortality due to unsafe abortion over the past decade, but access to second trimester abortion remains a challenge. The aim of this study is to better understand this issue by exploring the experiences of second-trimester abortion providers working in Addis Ababa, Ethiopia. Methods A qualitative study with 13 in-depth semi-structured interviews with 16 health workers directly involved in providing second-trimester abortions, this included obstetrician and gynaecologist specialists and residents, general practitioners, nurses, and midwives. Data was collected at four public hospitals and one non-governmental clinic in Addis Ababa, Ethiopia and analysed using Malterud’s text-condensation method. Results The providers recognized the critical need for second-trimester abortion services and were motivated by their empathy towards women who often sought care late due to marginalisation and poverty making it difficult to access abortion before the second trimester. However, service provision was challenging according to the providers, and barriers like lack of access to essential drugs and equipment, few providers willing to conduct abortions late in pregnancy and unclear guidelines were commonly experienced. This led to highly demanding working conditions. The providers experienced ethical dilemmas pertaining to the possible viability of the fetus and women desperately requesting the service after the legal limit. Conclusions Second-trimester abortion providers faced severe barriers and ethical dilemmas pushing their moral threshold and medical risk-taking in efforts to deliver second-trimester abortions to vulnerable women in need of the service. Effort is needed to minimize health system barriers and improve guidelines and support for second-trimester abortion providers in order to increase access and quality of second-trimester abortion services in Ethiopia. The barriers forcing women into second trimester abortions also need to be addressed

Guidelines and clinical priority setting during the COVID-19 pandemic – Norwegian doctors’ experiences

Background In the first phase of the COVID-19 pandemic, strong measures were taken to avoid anticipated pressure on health care, and this involved new priorities between patient groups and changing working conditions for clinical personnel. We studied how doctors experienced this situation. Our focus was their knowledge about and adherence to general and COVID-19 specific guidelines and regulations on priority setting, and whether actual priorities were considered acceptable. Methods In December 2020, 2 316 members of a representative panel of doctors practicing in Norway received a questionnaire. The questions were designed to consider a set of hypotheses about priority setting and guidelines. The focus was on the period between March and December 2020. Responses were analyzed with descriptive statistics and regression analyses. Results In total, 1 617 (70%) responded. A majority were familiar with the priority criteria, though not the legislation on priority setting. A majority had not used guidelines for priority setting in the first period of the pandemic. 60.5% reported that some of their patients were deprioritized for treatment. Of these, 47.5% considered it medically indefensible to some/a large extent. Although general practitioners (GPs) and hospital doctors experienced deprioritizations equally often, more GPs considered it medically indefensible. More doctors in managerial positions were familiar with the guidelines. Conclusions Most doctors did not use priority guidelines in this period. They experienced, however, that some of their patients were deprioritized, which was considered medically indefensible by many. This might be explained by a negative reaction to the externally imposed requirements for rationing, while observing that vulnerable patients were deprioritized. Another interpretation is that they judged the rationing to have gone too far, or that they found it hard to accept rationing of care in general. Priority guidelines can be useful measures for securing fair and reasonable priorities. However, if the priority setting in clinical practice is to proceed in accordance with priority-setting principles and guidelines, the guidelines must be translated into a clinically relevant context and doctors’ familiarity with them must improve