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1.
BMJ Health Care Inform ; 31(1)2024 Apr 19.
Article in English | MEDLINE | ID: mdl-38642921

ABSTRACT

OBJECTIVES: To explore the views of intensive care professionals in high-income countries (HICs) and lower-to-middle-income countries (LMICs) regarding the use and implementation of artificial intelligence (AI) technologies in intensive care units (ICUs). METHODS: Individual semi-structured qualitative interviews were conducted between December 2021 and August 2022 with 59 intensive care professionals from 24 countries. Transcripts were analysed using conventional content analysis. RESULTS: Participants had generally positive views about the potential use of AI in ICUs but also reported some well-known concerns about the use of AI in clinical practice and important technical and non-technical barriers to the implementation of AI. Important differences existed between ICUs regarding their current readiness to implement AI. However, these differences were not primarily between HICs and LMICs, but between a small number of ICUs in large tertiary hospitals in HICs, which were reported to have the necessary digital infrastructure for AI, and nearly all other ICUs in both HICs and LMICs, which were reported to neither have the technical capability to capture the necessary data or use AI, nor the staff with the right knowledge and skills to use the technology. CONCLUSION: Pouring massive amounts of resources into developing AI without first building the necessary digital infrastructure foundation needed for AI is unethical. Real-world implementation and routine use of AI in the vast majority of ICUs in both HICs and LMICs included in our study is unlikely to occur any time soon. ICUs should not be using AI until certain preconditions are met.


Subject(s)
Artificial Intelligence , Critical Care , Humans , Intensive Care Units , Knowledge , Qualitative Research
2.
BMC Public Health ; 24(1): 23, 2024 01 02.
Article in English | MEDLINE | ID: mdl-38166737

ABSTRACT

BACKGROUND: While solidarity practices were important in mitigating the Coronavirus Disease 2019 (COVID-19) pandemic, their limits became evident as the pandemic progressed. Taking a longitudinal approach, this study analyses German residents' changing perceptions of solidarity practices during the COVID-19 pandemic and examines potential reasons for these changes. METHODS: Adults living in Germany were interviewed in April 2020 (n = 46), October 2020 (n = 43) and October 2021 (n = 40) as part of the SolPan Research Commons, a large-scale, international, qualitative, longitudinal study uniquely situated in a major global public health crisis. Interviews were analysed using qualitative content analysis. RESULTS: While solidarity practices were prominently discussed and positively evaluated in April 2020, this initial enthusiasm waned in October 2020 and October 2021. Yet, participants still perceived solidarity as important for managing the pandemic and called for institutionalized forms of solidarity in October 2020 and October 2021. Reasons for these changing perceptions of solidarity included (i) increasing personal and societal costs to act in solidarity, (ii) COVID-19 policies hindering solidarity practices, and (iii) a perceived lack of reciprocity as participants felt that solidarity practices from the state were not matching their individual efforts. CONCLUSIONS: Maintaining solidarity contributes to maximizing public health during a pandemic. Institutionalized forms of solidarity to support those most in need contribute to perceived reciprocity among individuals, which might increase their motivation to act in solidarity. Thus, rather than calling for individual solidarity during times of crisis, authorities should consider implementing sustaining solidarity-based social support systems that go beyond immediate crisis management.


Subject(s)
COVID-19 , Adult , Humans , COVID-19/epidemiology , Longitudinal Studies , Pandemics , Germany/epidemiology , Qualitative Research
3.
Eur J Hum Genet ; 31(12): 1398-1406, 2023 12.
Article in English | MEDLINE | ID: mdl-37773517

ABSTRACT

The use of genome-wide sequencing (GWS) in paediatrics has added complexity to informed consent (IC) and pretest counselling because of the vast number and interpretation of potential findings, and their implications. However, empirical data from continental Europe on these issues remains limited. This study therefore aimed to explore the experiences and views of medical geneticists working with children in Germany and Switzerland regarding the challenges of obtaining valid IC in paediatric GWS. Qualitative interviews with 20 medical geneticists were analysed employing reflexive thematic analysis. In the interviews, many medical geneticists questioned the validity of parents' IC due to the enormous amount of relevant information given and the variety and complexity of the possible test outcomes. Key barriers identified included familial implications, administrative challenges and struggles with non-directiveness. Medical geneticists' suggestions for improvement included increasing the number of genetics professionals and better information material, which is crucial as GWS becomes a diagnostic standard in the early care pathways of children. An adjustment of aspirations from still existing ideal of traditional fully IC to appropriate IC seems to be needed. Such a more realistic and ethically sound adaptation of the requirements for IC can lead to better 'informedness' and improve the validity of the consent. This might also help reduce the moral distress for the medical geneticists involved.


Subject(s)
Dreams , Informed Consent , Humans , Child , Switzerland , Qualitative Research , Germany
4.
Med Sci Educ ; 33(2): 431-441, 2023 Apr.
Article in English | MEDLINE | ID: mdl-37261015

ABSTRACT

Background: Professional identity formation (PIF) is a life-long process, starting even before professional education. High levels of motivation for medical school are essential for effective learning and academic success. Both are key factors in future physicians' professional and personal development, and according to self-determination theory, professional identity (PI) and students' levels of motivation could be closely linked. Therefore, we sought to investigate whether PI and strength of motivation for medical school are associated in new medical students. Methods: In a cross-sectional survey, all new medical students in Munich, Germany, were asked to complete the Macleod Clark Professional Identity Scale (MCPIS-9) and the Strength of Motivation for Medical School-Revised questionnaire (SMMS-R) as well as to provide information about age, gender, and waiting time before starting medical school. Results: Eight hundred eleven out of 918 new medical students participated in the survey. A positive correlation between the MCPIS-9 and the SMMS-R (p < 0.001) was found. Female students showed higher scores in the SMMS-R (p < 0.05) and the SMMS-R-subscale Readiness to Start (p < 0.001). The amount of waiting semesters showed a positive correlation with the total SMMS-R score (p < 0.01) as well as with the subscales Readiness to Start and Persistence (both p < 0.001). Discussion: We found an association between PI and strength of motivation for medical school in a large cohort of new medical students. Female gender and more waiting semesters were associated with higher levels of self-perceived motivation and higher scores on the SMMS-R-subscale Readiness to Start. More research is needed to better understand this topic to further improve medical education.

5.
SSM Popul Health ; 22: 101388, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37008806

ABSTRACT

Solidarity and personal responsibility have been repeatedly called upon during the COVID-19 pandemic. This study quantifies and contextualizes the use of these terms in newspaper coverage in Germany and German-speaking Switzerland based on n = 640 articles from six functionally equivalent newspapers. The term solidarity in the context of the COVID-19 pandemic was mentioned in 541/640 articles (84.5%) and was primarily used during phases with high death rates and comparatively stringent policies in place, supporting the idea that solidarity was used to explain restrictive measures to the population and motivate people to comply with these measures. German newspapers published more articles on solidarity than Swiss-German newspapers, consistent with more stringent COVID-19 policies in Germany. Personal responsibility was mentioned in 133/640 articles (20.8%), meaning that the term was less frequently discussed than solidarity. Articles covering personal responsibility included more negative evaluations during phases of high infection rates as compared to phases of low infection rates. Findings indicate that the two terms were, at least to some extent, used in newspaper reporting to contextualize and justify COVID-19 policy during phases of high infection rates. Moreover, the term solidarity was used in a high variety of different contexts and the inherent limits of solidarity were rarely mentioned. Policymakers and journalists need to take this into account for future crises to not jeopardize the positive effects of solidarity.

6.
Front Genet ; 14: 1098439, 2023.
Article in English | MEDLINE | ID: mdl-36816027

ABSTRACT

Researchers aim to develop polygenic risk scores as a tool to prevent and more effectively treat serious diseases, disorders and conditions such as breast cancer, type 2 diabetes mellitus and coronary heart disease. Recently, machine learning techniques, in particular deep neural networks, have been increasingly developed to create polygenic risk scores using electronic health records as well as genomic and other health data. While the use of artificial intelligence for polygenic risk scores may enable greater accuracy, performance and prediction, it also presents a range of increasingly complex ethical challenges. The ethical and social issues of many polygenic risk score applications in medicine have been widely discussed. However, in the literature and in practice, the ethical implications of their confluence with the use of artificial intelligence have not yet been sufficiently considered. Based on a comprehensive review of the existing literature, we argue that this stands in need of urgent consideration for research and subsequent translation into the clinical setting. Considering the many ethical layers involved, we will first give a brief overview of the development of artificial intelligence-driven polygenic risk scores, associated ethical and social implications, challenges in artificial intelligence ethics, and finally, explore potential complexities of polygenic risk scores driven by artificial intelligence. We point out emerging complexity regarding fairness, challenges in building trust, explaining and understanding artificial intelligence and polygenic risk scores as well as regulatory uncertainties and further challenges. We strongly advocate taking a proactive approach to embedding ethics in research and implementation processes for polygenic risk scores driven by artificial intelligence.

7.
Vaccine ; 41(12): 2084-2092, 2023 03 17.
Article in English | MEDLINE | ID: mdl-36813665

ABSTRACT

The uptake ofCOVID-19 vaccines has varied considerably across European countries. This study investigates people's decision-making process regarding vaccination by analyzing qualitative interviews (n = 214) with residents from five European countries: Austria, Germany, Italy, Portugal, and Switzerland. We identify three factors that shape vaccination decision-making: individual experiences and pre-existing attitudes towards vaccination, social environment, and socio-political context. Based on this analysis, we present a typology of decision-making regarding COVID-19 vaccines, where some types present stable stances towards vaccines and others change over time. Trust in government and relevant stakeholders, broader social factors, and people's direct social environment were particularly relevant to these dynamics. We conclude that vaccination campaigns should be considered long-term projects (also outside of pandemics) in need of regular adjustment, communication and fine-tuning to ensure public trust. This is particularly pertinent for booster vaccinations, such as COVID-19 or influenza.


Subject(s)
COVID-19 , Influenza Vaccines , Vaccines , Humans , COVID-19 Vaccines , COVID-19/prevention & control , Vaccination , Qualitative Research , Europe
8.
J Clin Epidemiol ; 154: 208-211, 2023 02.
Article in English | MEDLINE | ID: mdl-36481252
9.
Public Health Ethics ; 16(3): 245-260, 2023 Nov.
Article in English | MEDLINE | ID: mdl-38333769

ABSTRACT

Throughout the COVID-19 pandemic, the concept of solidarity has been invoked frequently. Much interest has centred around how citizens and communities support one another during times of uncertainty. Yet, empirical research which accounts and understands citizen's views on pandemic solidarity, or their actual practices has remained limited. Drawing upon the analysis of data from 35 qualitative interviews, this article investigates how residents in England and Scotland enacted, understood, or criticised (the lack of) solidarity during the first national lockdown in the United Kingdom in April 2020-at a time when media celebrated solidarity as being at an all-time high. It finds that although solidarity was practiced by some people, the perceived lack of solidarity was just as pronounced. We conclude that despite frequent mobilisations of solidarity by policy makers and other public actors, actual practices of solidarity are poorly understood-despite the importance of solidarity for public health and policy.

10.
J Bioeth Inq ; 19(4): 643-653, 2022 12.
Article in English | MEDLINE | ID: mdl-36342632

ABSTRACT

BACKGROUND: Bioethics can play an important role in addressing diversity both in and outside of academia, setting precedents for meaningful contributions to public discourse, research, teaching, training, and policy development. However, in order to do so, these conversations also need to reflect on the issue of diversity within the field of bioethics across the globe. This study aims to examine current gender representation and diversity at medical ethics and humanities institutes in Germany, the German-speaking areas of Switzerland, and Austria. METHODS: A total of forty-nine medical ethics and humanities institutes from Germany (n=42), the German-speaking areas of Switzerland (n=5), and Austria (n=2) were included in the study. Institutes websites were reviewed in the first week of March 2021 and the details of each staff member listed on the website recorded. RESULTS: Overall, a total of 964 staff members were identified at the forty-nine German-speaking medical ethics and humanities institutes. Just over half (530/964; 55%) of all staff were female. There were significant differences between gender in some staff positions: 64.6 per cent (31/48) of directors were male (χ2(1)=4.1, P=.04); 62.7 per cent (84/134) of student assistants were female (χ2(1)=8.6, P=.003); and 83.7 per cent (77/92) of administrative staff were female (χ2(1)=41.8, P<.001). There were no significant differences between staff gender for researchers and lecturers, or associated researchers. In addition, 65.5 per cent (19/29) of researchers and lecturers who had a professor title were male, but the difference between genders was not found to be significant. However, significantly more of the researchers and lecturers who had completed a habilitation were male (75.8% (25/33); χ2(1)=8.8, P=.003). When comparing the institute director's gender presentation with staff gender presentation, it was found that male-led institutes had 53.4 per cent (286/536) female staff overall but had 52.7 per cent (136/258) male researchers and lecturers. However, the difference between genders were not found to be significant. On the other hand, female-led institutes had significantly more female staff overall (59.9% (223/372); χ2(1)=14.7, P<.001) and also significantly more female researchers and lecturers (58.9% (119/202; χ2(1)=6.4, P=.01). CONCLUSIONS: There has been a significant push to address gender diversity in German-speaking academia, and this study finds overall good gender parity in medical ethics and humanities institutes. However, there has not been a similar openness to discussing issues of systemic racism or how other forms of inequality affect academic diversity. Taking diversity seriously requires opening up conversations around intersectionality, including difficult conversations around race and cultural background that have long been taboo in German-speaking countries.


Subject(s)
Bioethics , Education, Medical , Humans , Male , Female , Humanities , Ethics, Medical , Curriculum , Switzerland
11.
SSM Qual Res Health ; 2: 100158, 2022 Dec.
Article in English | MEDLINE | ID: mdl-36092769

ABSTRACT

The sudden and dramatic advent of the COVID-19 pandemic led to urgent demands for timely, relevant, yet rigorous research. This paper discusses the origin, design, and execution of the SolPan research commons, a large-scale, international, comparative, qualitative research project that sought to respond to the need for knowledge among researchers and policymakers in times of crisis. The form of organization as a research commons is characterized by an underlying solidaristic attitude of its members and its intrinsic organizational features in which research data and knowledge in the study is shared and jointly owned. As such, the project is peer-governed, rooted in (idealist) social values of academia, and aims at providing tools and benefits for its members. In this paper, we discuss challenges and solutions for qualitative studies that seek to operate as research commons.

12.
SSM Qual Res Health ; 2: 100051, 2022 Dec.
Article in English | MEDLINE | ID: mdl-35975169

ABSTRACT

Politicians, policymakers, and mass media alike have emphasized the importance of solidarity during the COVID-19 pandemic, calling for the need of social cohesion in society to protect risk groups and national healthcare systems. In this study, which is part of an international Consortium, we analyzed 77 qualitative interviews with members of the general public in Germany and German-speaking areas of Switzerland on solidaristic behavior and its limits during the first COVID-19 related lockdown in April 2020. We found interdependencies between the interpersonal, group, and state tiers of solidarity that offer insights into what promotes solidaristic practice and what does not. We argue that because solidarity does not have a necessary and sufficient normative value in itself, those wanting to promote solidarity need to consider these interdependencies to effectively implement policy measures. Our study shows that inter-societal solidarity was based on individual voluntary agency and promoted through recognizing a shared goal, shared values, or other communalities including group effort. It also shows that individuals held state authorities accountable for the same values and expect inter-societal reciprocity from the contractual level. Tensions between those complying or willing to follow recommendations voluntarily and those perceived as not promoting the shared goal, posed challenges for solidarity. Another challenge for solidaristic behavior was when acting in solidarity with others was in direct conflict with the needs of close ones. Our study provides a clearer picture of promoting and limiting factors concerning solidarity which is relevant when communicating health policy measures to individuals and groups.

14.
Front Genet ; 13: 929453, 2022.
Article in English | MEDLINE | ID: mdl-35769991

ABSTRACT

Artificial intelligence (AI) in healthcare promises to make healthcare safer, more accurate, and more cost-effective. Public and private actors have been investing significant amounts of resources into the field. However, to benefit from data-intensive medicine, particularly from AI technologies, one must first and foremost have access to data. It has been previously argued that the conventionally used "consent or anonymize approach" undermines data-intensive medicine, and worse, may ultimately harm patients. Yet, this is still a dominant approach in European countries and framed as an either-or choice. In this paper, we contrast the different data governance approaches in the EU and their advantages and disadvantages in the context of healthcare AI. We detail the ethical trade-offs inherent to data-intensive medicine, particularly the balancing of data privacy and data access, and the subsequent prioritization between AI and other effective health interventions. If countries wish to allocate resources to AI, they also need to make corresponding efforts to improve (secure) data access. We conclude that it is unethical to invest significant amounts of public funds into AI development whilst at the same time limiting data access through strict privacy measures, as this constitutes a waste of public resources. The "AI revolution" in healthcare can only realise its full potential if a fair, inclusive engagement process spells out the values underlying (trans) national data governance policies and their impact on AI development, and priorities are set accordingly.

15.
J Med Internet Res ; 24(6): e38754, 2022 06 27.
Article in English | MEDLINE | ID: mdl-35696598

ABSTRACT

BACKGROUND: The COVID-19 pandemic is a threat to global health and requires collaborative health research efforts across organizations and countries to address it. Although routinely collected digital health data are a valuable source of information for researchers, benefiting from these data requires accessing and sharing the data. Health care organizations focusing on individual risk minimization threaten to undermine COVID-19 research efforts, and it has been argued that there is an ethical obligation to use the European Union's General Data Protection Regulation (GDPR) scientific research exemption during the COVID-19 pandemic to support collaborative health research. OBJECTIVE: This study aims to explore the practices and attitudes of stakeholders in the German federal state of Bavaria regarding the secondary use of health data for research purposes during the COVID-19 pandemic, with a specific focus on the GDPR scientific research exemption. METHODS: Individual semistructured qualitative interviews were conducted between December 2020 and January 2021 with a purposive sample of 17 stakeholders from 3 different groups in Bavaria: researchers involved in COVID-19 research (n=5, 29%), data protection officers (n=6, 35%), and research ethics committee representatives (n=6, 35%). The transcripts were analyzed using conventional content analysis. RESULTS: Participants identified systemic challenges in conducting collaborative secondary-use health data research in Bavaria; secondary health data research generally only happens when patient consent has been obtained, or the data have been fully anonymized. The GDPR research exemption has not played a significant role during the pandemic and is currently seldom and restrictively used. Participants identified 3 key groups of barriers that led to difficulties: the wider ecosystem at many Bavarian health care organizations, legal uncertainty that leads to risk-adverse approaches, and ethical positions that patient consent ought to be obtained whenever possible to respect patient autonomy. To improve health data research in Bavaria and across Germany, participants wanted greater legal certainty regarding the use of pseudonymized data for research purposes without the patient's consent. CONCLUSIONS: The current balance between enabling the positive goals of health data research and avoiding associated data protection risks is heavily skewed toward avoiding risks; so much so that it makes reaching the goals of health data research extremely difficult. This is important, as it is widely recognized that there is an ethical imperative to use health data to improve care. The current approach also creates a problematic conflict with the ambitions of Germany, and the federal state of Bavaria, to be a leader in artificial intelligence. A recent development in the field of German public administration known as norm screening (Normenscreening) could potentially provide a systematic approach to minimize legal barriers. This approach would likely be beneficial to other countries.


Subject(s)
COVID-19 , Artificial Intelligence , Attitude , COVID-19/epidemiology , COVID-19/prevention & control , Ecosystem , Humans , Pandemics/prevention & control , Qualitative Research
16.
BMC Med Res Methodol ; 22(1): 142, 2022 05 19.
Article in English | MEDLINE | ID: mdl-35590285

ABSTRACT

BACKGROUND: Whether there is sufficient capacity and capability for the successful conduct and delivery of a clinical trial should be assessed by several stakeholders according to transparent and evidence-based criteria during trial planning. For this openly shared, user-tested, and validated tools are necessary. Therefore, we systematically examined the public availability and content of checklists which assess the study-level feasibility in the planning phase of clinical trials. METHODS: In our scoping review we systematically searched Medline, EMBASE, and Google (last search, June 2021). We included all publicly available checklists or tools that assessed study level feasibility of clinical trials, examined their content, and checked whether they were user-tested or validated in any form. Data was analysed and synthesised using conventional content analysis. RESULTS: A total of 10 publicly available checklists from five countries were identified. The checklists included 48 distinct items that were classified according to the following seven different domains of clinical trial feasibility: regulation, review and oversight; participant recruitment; space, material and equipment; financial resources; trial team resources; trial management; and pilot or feasibility studies. None of the available checklists appeared to be user-tested or validated. CONCLUSIONS: Although a number of publicly available checklists to assess the feasibility of clinical trials exist, their reliability and usefulness remain unclear. Openly shared, user-tested, and validated feasibility assessment tools for a better planning of clinical trials are lacking.


Subject(s)
Checklist , Clinical Trials as Topic , Feasibility Studies , Humans , Reproducibility of Results
17.
PLoS One ; 17(4): e0266659, 2022.
Article in English | MEDLINE | ID: mdl-35390085

ABSTRACT

Public perceptions of COVID-19 vaccines are critical in reaching protective levels of herd immunity. Vaccine skepticism has always been relatively high in Germany, and surveys suggest that over the course of the pandemic, enthusiasm for the COVID-19 vaccine has dropped. Looking at the period just prior to the approval of the Pfizer/BioNTech and Moderna vaccines in Germany in the latter half of 2020, this paper aims to assess the reasons for and against COVID-19 vaccine uptake among residents of Germany, and to provide in-depth qualitative data to better understand and address concerns surrounding the safety and efficacy of a COVID-19 vaccine. Our findings indicate that there is widespread trust in German institutions and health experts to provide a safe vaccine for those who need it most. However, interviewees also point to the need for more information and the centrality of support from trusted medical authorities in making individual vaccination decisions. We also present the complexity of individual positions on vaccination, and suggest that vaccine hesitancy in relation to COVID-19 needs to be understood as a nuanced, and socially malleable, territory. This indicates that the goal of a vaccination campaign is not only achieving 'herd immunity,' but also a social endorsement of the collaborative effort that is required for a vaccine to be successful.


Subject(s)
COVID-19 , Vaccines , COVID-19/epidemiology , COVID-19/prevention & control , COVID-19 Vaccines , Germany/epidemiology , Humans , Pandemics/prevention & control , SARS-CoV-2 , Trust , Vaccination
18.
PLoS One ; 17(3): e0264427, 2022.
Article in English | MEDLINE | ID: mdl-35245312

ABSTRACT

BACKGROUND: Conducting high quality investigator-initiated trials (IITs) is challenging and costly. The costs of investigational medicinal products (IMPs) in IITs and the role of hospital pharmacies in the planning of IITs are unclear. We conducted a mixed-methods study to compare planned and actual costs of IMPs in Swiss IITs, to examine potential reasons for differences, and to gather stakeholder views about hospital services for IITs. METHODS: We included all IITs with IMP services from the Basel hospital pharmacy invoiced between January 2014 and June 2020 (n = 24). We documented trial and IMP characteristics including planned and actual IMP costs. Our working definition for a substantial cost difference was that the actual IMP costs were more than 10% higher than the planned IMP costs in a trial. We conducted semi-structured interviews with investigators, clinical trials unit and hospital pharmacy staff, and qualitatively analyzed transcribed interviews. RESULTS: For 13 IITs we observed no differences between planned and actual costs of IMPs (median, 11'000 US$; interquartile range [IQR], 8'882-16'302 US$), but for 11 IITs we found cost increases from a median of 11'000 US$ (IQR, 8'922-36'166 US$) to a median over 28'000 US$ (IQR, 13'004-49'777 US$). All multicenter trials and 10 of 11 IITs with patients experienced substantial cost differences. From the interviews we identified four main themes: 1) Patient recruitment and organizational problems were identified as main reasons for cost differences, 2) higher actual IMP costs were bearable for most investigators, 3) IMP services for IITs were not a priority for the hospital pharmacy, and 4) closer collaboration between clinical trial unit and hospital pharmacy staff, and sufficient staff for IITs at the hospital pharmacy could improve IMP services. CONCLUSIONS: Multicenter IITs enrolling patients are particularly at risk for higher IMP costs than planned. These trials are more difficult to plan and logistically challenging, which leads to delays and expiring IMP shelf-lives. IMP services of hospital pharmacies are important for IITs in Switzerland, but need to be further developed.


Subject(s)
Pharmacies , Pharmacy Service, Hospital , Humans , Organizations , Research Personnel
19.
J Clin Epidemiol ; 145: 136-143, 2022 05.
Article in English | MEDLINE | ID: mdl-35124187

ABSTRACT

BACKGROUND AND OBJECTIVE: When a randomized clinical trial (RCT) prematurely discontinues, it is essential that stakeholders do the right thing to ensure that lessons can be learnt and trust in clinical research is maintained. There is, however, a lack of evidence exploring this issue. This study aimed to examine clinical trial stakeholders' practices following trial discontinuation due to poor participant recruitment and their views on implications of such discontinuation. METHODS: Individual semi-structured qualitative interviews were conducted with 49 clinical trial stakeholders from Switzerland (n = 39), Germany (n = 9) and Canada (n = 1) between August 2015 and November 2016. RESULTS: After interviews with 49 clinical trial stakeholders (75% male presenting), it was found that stakeholders were aware of the risks of premature trial discontinuation wasting limited resources, adversely impacting scientific evidence, and having negative personal and professional implications. However, barriers continue to undermine transparency regarding trial discontinuation in practice, with it being reported that most investigators of discontinued trials are failing to notify stakeholders or publishing their results. Investigators sense of failure and associated negative emotions were identified as a key reason why investigators are not more transparent following discontinuation. CONCLUSION: The decision to notify stakeholders and publish results of a discontinued clinical trial should not rest solely on individual investigators but come from a systemic approach. However, until health research proactively requires the dissemination of results of all clinical trials, much will rest on individual investigators being motivated to do the right thing. Support programs might be helpful for investigators involved in discontinued trials and promote transparency and learning lessons.


Subject(s)
Publishing , Research Personnel , Female , Germany , Humans , Male , Patient Selection , Risk Factors
20.
PLoS One ; 17(2): e0263786, 2022.
Article in English | MEDLINE | ID: mdl-35143577

ABSTRACT

This study investigated the effect of five post-weaning supplementation strategies and two weaning weight groups on long-term growth, puberty and pregnancy percentage of Brahman crossbred heifers. Early-weaned (118 ± 6 kg liveweight) and normally-weaned (183 ± 6 kg liveweight) heifers were allocated to group pens (n = 4 and n = 5/pen for early- and normally-weaned respectively) and offered one of five levels of post-weaning protein supplementation: 0, 1, 2.5, 5 and 10 g of supplement/kg liveweight.day with ad libitum access to a low quality sabi grass (Urochloa mosambicensis) hay during the first dry season (169 days) after weaning. After the post-weaning supplementation period, all heifers grazed the same pastures as a single mob until the end of the experiment and were exposed to fertile bulls from January to May 2016. During the first dry season, supplement intake had a positive linear effect on liveweight gain and hip width gain with no difference in the response between weaning groups. Overall, heifers with higher supplement intakes (i.e. 5 and 10 g/kg) had higher hip height gain (P < 0.005), hip width gain (P < 0.001), body condition score (P < 0.001), and concentration of insulin-like growth factor-1 (P = 0.001), triiodothyronine (P = 0.04) and insulin (P = 0.05) in plasma compared to unsupplemented heifers. These changes resulted in thicker proliferative and hypertrophic zones (both P = 0.03) of the tuber coxae growth plate, larger diameter of terminal hypertrophic chondrocytes (both P = 0.004) at the end of the post-weaning supplementation period when comparing the highest level of supplementation with unsupplemented group. Unsupplemented heifers from both weaning weight groups demonstrated compensatory liveweight gain over the first wet season while evidence of catch-up growth in skeletal dimensions was observed in the second wet season. The main determining factor for pregnancy status of two-year-old Brahman crossbred heifers was pre-mating liveweight (P < 0.001), the pre-mating liveweight was in turn affected by post-weaning supplementation (P = 0.02) or weaning weight group (P < 0.001). This study further demonstrated the positive relationship between premating weight and the occurrence of pregnancy, with an approximate 300 kg pre-mating liveweight required to achieve approximately 80% (67.1-90.3% for a 95% confidence interval) probability of pregnancy in two-year-old Brahman crossbred heifers mated for 4 months.


Subject(s)
Animal Feed/analysis , Body Weight/physiology , Reproduction/physiology , Animal Nutritional Physiological Phenomena , Animals , Cattle , Hybridization, Genetic , Weaning
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