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Background: Systems medicine is the name for an assemblage of scientific strategies and practices that include bioinformatics approaches to human biology (especially systems biology); "big data" statistical analysis; and medical informatics tools. Whereas personalized and precision medicine involve similar analytical methods applied to genomic and medical record data, systems medicine draws on these as well as other sources of data. Given this distinction, the clinical translation of systems medicine poses a number of important ethical and epistemological challenges for researchers working to generate systems medicine knowledge and clinicians working to apply it.Discussion: This article focuses on three key challenges: First, we will discuss the conflicts in decision-making that can arise when healthcare providers committed to principles of experimental medicine or evidence-based medicine encounter individualized recommendations derived from computer algorithms. We will explore in particular whether controlled experiments, such as comparative effectiveness trials, should mediate the translation of systems medicine, or if instead individualized findings generated through "big data" approaches can be applied directly in clinical decision-making. Second, we will examine the case of the Riyadh Intensive Care Program Mortality Prediction Algorithm, pejoratively referred to as the "death computer," to demonstrate the ethical challenges that can arise when big-data-driven scoring systems are applied in clinical contexts. We argue that the uncritical use of predictive clinical algorithms, including those envisioned for systems medicine, challenge basic understandings of the doctor-patient relationship. Third, we will build on the recent discourse on secondary findings in genomics and imaging to draw attention to the important implications of secondary findings derived from the joint analysis of data from diverse sources, including data recorded by patients in an attempt to realize their "quantified self." This paper examines possible ethical challenges that are likely to be raised as systems medicine to be translated into clinical medicine. These include the epistemological challenges for clinical decision-making, the use of scoring systems optimized by big data techniques and the risk that incidental and secondary findings will significantly increase. While some ethical implications remain still hypothetical we should use the opportunity to prospectively identify challenges to avoid making foreseeable mistakes when systems medicine inevitably arrives in routine care. [ABSTRACT FROM AUTHOR]

Clinical decision support systems (CDSS) based on artificial intelligence (AI) are complex socio-technical innovations and are increasingly being used in medicine and nursing to improve the overall quality and efficiency of care, while also addressing limited financial and human resources. However, in addition to such intended clinical and organisational effects, far-reaching ethical, social and legal implications of AI-based CDSS on patient care and nursing are to be expected. To date, these normative-social implications have not been sufficiently investigated. The BMBF-funded project DESIREE (DEcision Support In Routine and Emergency HEalth Care: Ethical and Social Implications) has developed recommendations for the responsible design and use of clinical decision support systems. This article focuses primarily on ethical and social aspects of AI-based CDSS that could have a negative impact on patient health. Our recommendations are intended as additions to existing recommendations and are divided into the following action fields with relevance across all stakeholder groups: development, clinical use, information and consent, education and training, and (accompanying) research., (© 2024. The Author(s).)

Machine learning-driven clinical decision support systems (ML-CDSSs) seem impressively promising for future routine and emergency care. However, reflection on their clinical implementation reveals a wide array of ethical challenges. The preferences, concerns and expectations of professional stakeholders remain largely unexplored. Empirical research, however, may help to clarify the conceptual debate and its aspects in terms of their relevance for clinical practice. This study explores, from an ethical point of view, future healthcare professionals' attitudes to potential changes of responsibility and decision-making authority when using ML-CDSS. Twenty-seven semistructured interviews were conducted with German medical students and nursing trainees. The data were analysed based on qualitative content analysis according to Kuckartz. Interviewees' reflections are presented under three themes the interviewees describe as closely related: (self-)attribution of responsibility, decision-making authority and need of (professional) experience. The results illustrate the conceptual interconnectedness of professional responsibility and its structural and epistemic preconditions to be able to fulfil clinicians' responsibility in a meaningful manner. The study also sheds light on the four relata of responsibility understood as a relational concept. The article closes with concrete suggestions for the ethically sound clinical implementation of ML-CDSS., Competing Interests: Competing interests: HUZ is the scientific coordinator of the junior consortium CKDNapp, which is developing a CDSS for practicing nephrologists which was used for this study. She had no involvement in developing the interview guide, conducting the interviews or analyzing the interviews., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Adverse events (AE) are ubiquitous in home mechanical ventilation (HMV) and can jeopardise patient safety. One particular source of error is human interaction with life-sustaining medical devices, such as the ventilator. The objective is to understand these errors and to be able to take appropriate action. With a systematic analysis of the hazards associated with HMV and their causes, measures can be taken to prevent damage to patient health., Methods: A systematic adverse events analysis process was conducted to identify the causes of AE in intensive home care. The analysis process consisted of three steps. 1) An input phase consisting of an expert interview and a questionnaire. 2) Analysis and categorisation of the data into a root-cause diagram to help identify the causes of AE. 3) Derivation of risk mitigation measures to help avoid AE., Results: The nursing staff reported that patient transportation, suction and tracheostomy decannulation were the main factors that cause AE. They would welcome support measures such as checklists for care activities and a reminder function, for e.g. tube changes. Risk mitigation measures are given for many of the causes listed in the root-cause diagram. These include measures such as device and care competence, as well as improvements to be made by the equipment providers and manufacturers. The first step in addressing AE is transparency and an open approach to errors and near misses. A systematic error analysis can prevent patient harm through a preventive approach., Conclusion: Risks in HMV were identified based on a qualitative approach. The collected data was systematically mapped onto a root-cause diagram. Using the root-cause diagram, some of the causes were analysed for risk mitigation. For manufacturers, caregivers and care services requirements for intervention offers the possibility to create a checklist for particularly risky care activities., (© 2022. The Author(s).)

Background: Data collected during routine health care and ensuing analytical results bear the potential to provide valuable information to improve the overall health care of patients. However, little is known about how patients prefer to be informed about the possible usage of their routine data and/or biosamples for research purposes before reaching a consent decision. Specifically, we investigated the setting, the timing and the responsible staff for the information and consent process., Methods: We performed a quasi-randomized controlled trial and compared the method by which patients were informed either in the patient admission area following patient admission by the same staff member (Group A) or in a separate room by another staff member (Group B). The consent decision was hypothetical in nature. Additionally, we evaluated if there was the need for additional time after the information session and before taking the consent decision. Data were collected during a structured interview based on questionnaires where participants reflected on the information and consent process they went through., Results: Questionnaire data were obtained from 157 participants in Group A and 106 participants in Group B. Overall, participants in both groups were satisfied with their experienced process and with the way information was provided. They reported that their (hypothetical) consent decision was freely made. Approximately half of the interested participants in Group B did not show up in the separate room, while all interested participants in Group A could be informed about the secondary use of their routine data and left-over samples. No participants, except for one in Group B, wanted to take extra time for their consent decision. The hypothetical consent rate for both routine data and left-over samples was very high in both groups., Conclusions: The willingness to support medical research by allowing the use of routine data and left-over samples seems to be widespread among patients. Information concerning this secondary data use may be given by trained administrative staff immediately following patient admission. Patients mainly prefer making a consent decision directly after information is provided and discussed. Furthermore, less patients are informed when the process is organized in a separate room., (© 2022. The Author(s).)

Background: Defining and protecting participants' rights is the aim of several ethical codices and legal regulations. According to these regulations, the Informed Consent (IC) is an inevitable element of research with human subjects. In the era of "big data medicine", aspects of IC become even more relevant since research becomes more complex rendering compliance with legal and ethical regulations increasingly difficult., Methods: Based on literature research and practical experiences gathered by the Institute for Community Medicine (ICM), University Medicine Greifswald, requirements for digital consent management systems were identified., Results: To address the requirements, the free-of-charge, open-source software "generic Informed Consent Service" (gICS ® ) was developed by ICM to provide a tool to facilitate and enhance usage of digital ICs for the international research community covering various scenarios. gICS facilitates IC management based on IC modularisation and supports various workflows within research, including (1) electronic depiction of paper-based consents and (2) fully electronic consents. Numerous projects applied gICS and documented over 336,000 ICs and 2400 withdrawals since 2014., Discussion: Since the consent's content is a prerequisite for securing participants' rights, application of gICS is no guarantee for legal compliance. However, gICS supports fine-granular consents and accommodation of differentiated consent states, which can be directly exchanged between systems, allowing automated data processing., Conclusion: gICS simplifies and supports sustained IC management as a major key to successfully conduct studies and build trust in research with human subjects. Therefore, interested researchers are invited to use gICS and provide feedback for further improvements.

Objectives: Based on an analysis of the potential consequences of disclosing AD suspicions from respective research and using the research ethical principle of non-maleficence, the authors of this paper argue for the thesis that the benefits of early AD detection in research outweigh the risk of potential adverse effects only in cases where studies are conducted with symptomatic people actively seeking for support, e.g. as they utilize the services of memory clinics., Conclusion: In the case of non-symptomatic volunteers, the result of the risk-benefit-assessment seems to be less distinctive. Given that disclosing results can, at least initially, cause severe distress and harm and taking into account that research examinations have a significantly increased risk of producing false-positive findings, we suggest to make use of a research-ethical "princple of caution" that supports a restrictive disclosure policy for the second group of potential study participants. This differentiated view on the benefits of disclosed findings in AD research is reflected in recommendations for the set-up of return of result processes., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.)

Research and innovation in healthcare can change existing practices aiming at constant improvement of diagnosis, treatment and prevention. As a new holistic approach Systems Medicine (SM) may revolutionize the healthcare system. This paper analyzes ethical and economic obstacles of SMs development from a niche innovation to a standard solution. We adapt a model of innovation theory to structure the barriers of adopting SM to become standard in the medical system. SM has the potential to change the medical system if barriers to this innovation can be overcome. The article discusses the potential of SM in becoming the future health paradigm considering these barriers and provides an overview of the current situation.

Background: Individualized Medicine aims at providing optimal treatment for an individual patient at a given time based on his specific genetic and molecular characteristics. This requires excellent clinical stratification of patients as well as the availability of genomic data and biomarkers as prerequisites for the development of novel diagnostic tools and therapeutic strategies. The University Medicine Greifswald, Germany, has launched the "Greifswald Approach to Individualized Medicine" (GANI_MED) project to address major challenges of Individualized Medicine. Herein, we describe the implementation of the scientific and clinical infrastructure that allows future translation of findings relevant to Individualized Medicine into clinical practice., Methods/design: Clinical patient cohorts (N > 5,000) with an emphasis on metabolic and cardiovascular diseases are being established following a standardized protocol for the assessment of medical history, laboratory biomarkers, and the collection of various biosamples for bio-banking purposes. A multi-omics based biomarker assessment including genome-wide genotyping, transcriptome, metabolome, and proteome analyses complements the multi-level approach of GANI_MED. Comparisons with the general background population as characterized by our Study of Health in Pomerania (SHIP) are performed. A central data management structure has been implemented to capture and integrate all relevant clinical data for research purposes. Ethical research projects on informed consent procedures, reporting of incidental findings, and economic evaluations were launched in parallel.

Incidental findings have long posed challenges for healthcare providers, but the scope and scale of these challenges have increased with the introduction of new technologies. This article assesses the impact of incidental findings on the introduction of prospective pharmacogenomic testing into clinical use. Focusing on the challenges of the incidentalome, the large set of incidental findings potentially generated through genotyping, the paper argues that provisional approaches to managing incidental findings may be implemented if necessary to allow benefits of pharmacogenomic testing to be realized in the clinical setting. In the longer term, approaches to returning incidental findings may need to focus on limiting the number of incidental findings to a number that can be addressed by patients and providers.

Objectives: Little is known about the psychosocial impact and subjective interpretation of communicated incide ntal findings from whole-body magnetic resonance imaging (wb-MRI). This was addressed with this general population study., Methods: Data was based on the Study of Health in Pomerania (SHIP), Germany. SHIP comprised a 1.5-T wb-MRI examination. A postal survey was conducted among the first 471 participants, aged 23-84 years, who received a notification about incidental findings (response 86.0 %, n = 405). The severity of incidental findings was assessed from the participants' and radiologists' perspective., Results: In total, 394 participants (97.3 %) wanted to learn about their health by undergoing wb-MRI. Strong distress while waiting for a potential notification of an incidental finding was reported by 40 participants (9.9 %), whereas 116 (28.6 %) reported moderate to severe psychological distress thereafter. Strong disagreement was noted between the subjective and radiological evaluation of the findings' severity (kappa = 0.02). Almost all participants (n = 389, 96.0 %) were very satisfied with their examination., Conclusions: Despite the high satisfaction of most participants, there were numerous adverse consequences concerning the communication of incidental findings and false expectations about the likely potential benefits of whole-body-MRI., Key Points: • Disclosed incidental findings from MRI may lead to substantial psychosocial distress. • Subjective and radiological evaluations of incidental findings' severity differ strongly. • Disclosing incidental findings is strongly endorsed by study volunteers. • Study volunteers tend to have false expectations about potential benefits from MRI. • Minimizing stress in study volunteers should be a key aim in MRI research.

In this article, two different scientific approaches to personalized medicine are compared. Biorepository at Vanderbilt University (BioVU) is a genomic biorepository at Vanderbilt University Medical Center in Nashville, TN, USA. Genetic biosamples are collected from leftover clinical blood samples; medical information is derived from an electronic medical records. Greifswald Approach to Individualized Medicine is a research resource at the University of Greifswald, Germany, comprised of clinical records combined with biosamples collected for research. We demonstrate that although both approaches are based on the collection of clinical data and biosamples, different legal milieus present in the USA and Germany as well as slight differences in scientific goals have led to different 'ethical designs'. While BioVU can successfully operate with an 'opt-out' mechanism, an informed consent-based 'opt-in' model is indispensable to allow GANI_MED to reach its scientific goals.

Similar to clinical practise, population-based studies with a clinical-epidemiological focus include imaging techniques to identify manifest disease and to assess subclinical disease. Even population-based cross-sectional studies offer various options to address scientific questions of great clinical relevance, including analysis of reference values, prevalence estimates and association analysis. Further potential values of imaging techniques in population-based studies concern additional information on incidental diseases and mortality rate, which make it possible to investigate the association between imaging findings at baseline and subsequent disease. Modern population-based designs ensure a high degree of being representative and can be generally applied to clinical practise and, as a result, may be highly relevant to daily clinical routine. When imaging techniques are integrated within population-based research, problems of quality control may have to be solved, all probands must give informed consent and a decision made on what findings have to be given to the participants., (Georg Thieme Verlag KG Stuttgart, New York.)

Blood samples taken by venipuncture in calves within 12 hours after delivery and again in the same animals within 5 to 23 days of postnatal life were analyzed for hematocrit and fifteen other biochemical values. The changes of blood values between these two sampling points in each individual calf were investigated by regression analysis. Remarkable individual reactions and effects of the constitution of the animal immediately after delivery on the level and on the changes of the biochemical values could be observed as well as great deviations of some blood values of twin calves too. The scattering of some blood values and their changes in the first days of postnatal life are discussed regarding the maturity of the calves as well as the possible incidence of deficiency states or the setting of a new level for these physiological values.

In a large dairy cattle herd blood samples taken by venipuncture in newborn calves within 0 to 12 hours after delivery were analysed for hematocrit and fifteen other variables. The time of birth and the time of blood sampling and of first colostrum supply were recorded as well as body weight, sex and breed of the animals. Blood sampling in dairy cows was performed in the course of a herd health programme. The effects of the above-mentioned factors on the blood values of calves were investigated. Comparing the blood values of the pregnant cows with those of their newborn calves led to the result that in calves the measures were higher than (Hkt, Thyroxine), equal to (urea, P, Ca, Zn, Mg, K, Na, TIBC) or below (total protein, albumin, gammaglobulin, cholesterol, coeruloplasmin, Fe, Cu) those of their dams. There was great scattering of the concentrations of Zn, Cu, Mg, Fe, TIBC, total protein, albumin and in hematocrit. Uptake of colostrum caused the concentration of Mg, total protein and gammaglobulin to increase and those of albumin and hematocrit to decrease, leaving the levels of P and blood urea unchanged.

Organ weight and trace element analyses were performed on 75 stillborn calves from the same dairy cow herd. The elements Fe, Mn, Zn and Cu were measured in the livers of 66 of the calves. The calves ranged in age from 259 to 299 days of gestation, and in weight from 18 to 58 kg. Based on the quotients of organ and other body parts, stage of growth of the humerus and age, the animals were grouped as either preterm (P), term but light (TL), and term with appropriate weight (TA) calves. In P group calves the heart, lungs, liver, kidneys, thymus, spleen and thyroid glands were relatively heavy. In the TL group calves the brain, heart, lungs and thyroid glands were relatively heavy whereas the spleen and thymus were comparatively light. The liver Fe and Zn values were lower in this group than in the other 2 groups.

Stillborn calves of a large dairy cattle herd were used for investigations of trace element (Fe, Zn, Cu, Mn) content of the liver and heart muscle. Trace element content varied markedly in the liver and in the heart muscle too but in the heart muscle with a smaller degree. Calves from heifers had a greater trace element content in the liver and heart muscle than those from cows. Premature calves had small amounts of Mn and Cu in their livers and small but term calves had less Fe and Zn in their livers. Single calves from cows had a greater amount of trace elements in the liver and heart muscle than twin calves.

Trace element analyses were performed on the livers of 52 and the heart muscle of 19 stillborn dairy calves. All calves originated from one herd and ranged in age from 260 days of gestation up to one day old. In the liver the trace element concentrations (mg/kg fresh weight) were as follows: Fe: 181.3 +/- 173.5; Zn: 74.6 +/- 37.7; Cu: 98.1 +/- 42.6; Mn: 1.4 +/- 0.36 and in the heart: Fe: 54.1 +/- 10.6; Zn: 16.3 +/- 3.8; Cu: 2.5 +/- 0.99; Mn: 0.42 +/- 0.07. Calves from heifers had lower Cu values. The relationship between trace element concentration and content and liver and heart weight is discussed, as are aspects of bioavailability and storage mechanisms as well as clinical signs of trace metal deficiencies.

Stillborn calves (80 animals) originating from one dairy herd were used for studies on allometric measures in newborn calves. In the first approach some factors were neglected and only the effect of the calves' sex was considered. Differences in mean birthweight between male and female calves were reflected in organ and other body constituent weights too, but with different relations between them. Enlarged thyroid glands could be observed in both sexes but more often in female calves meaning that there is no correlation between thyroid size and body weight. Strong correlations of bones, muscles and outer body measures and looser ones of internal organs (thymus, liver, lung, kidneys, spleen) and endocrine glands (adrenal glands) with body weight were found especially in male calves. In some calves the sometimes enlarged liver looked like a fatty liver with its pale yellowish appearance and crumbly consistency.

Post-mortem examinations were carried out on 65 calves which were stillborn or died within 24 hours of birth. All calves came from a large dairy unit with about one thousand cattle of the Schwarzbuntes Milchrind breed. To evaluate the perinatal losses, the farm records of parturitions from 1985-1990 were used. The calves had gross damage of the CNS, the musculature, subcutaneous tissue and internal organs such as lung and intestines. It may be assumed that a lesser degree of similar damage would also be present in the surviving calves. The level of perinatal losses is determined particularly by deaths following prolonged parturition due to foetal oversize in heifers and young cows, but also by the birth of immature calves of low weight after pregnancy of normal or decreased duration and by twin pregnancies with high total calf mass and relative immaturity of the calves.