KEY POINTS In Canada, commercial data brokers collect deidentified patient data from pharmacies, private drug insurers, the federal government and medical clinics without patient consent. Although pharmaceutical companies are the data brokers’ primary customers, academics and nonprofit and public entities also use commercial data sets, given the absence of a coordinated public approach to collecting these data across Canada. Risks of commercialized patient data include loss of anonymity, surveillance and marketing, discrimination (...) and violation of Indigenous data sovereignty. Coordinated infrastructure for the collection and coordination of health data across Canada and updated privacy legislation would protect individuals and communities and enable appropriate data uses. (shrink)

Background: I suggest this individualized care is a fundamental principle closely linked to nursing ethics and has important benefits for the patients, however, nurses do not always take into consideration the principles of individualized care. Moreover, there is no validated instrument to assess patients’ views of individualized care in Spanish-speaking countries. Objectives: To assess the validity and reliability of the Spanish version of the Individualized Care Scale-patient. Design: A cross-sectional study design was conducted. A questionnaire survey, including the Individualized (...) Care Scale-patient, was used for data collection. Psychometric properties of reliability and validity were assessed. Fit indices of the overall model were computed. Participants and research context: Survey data were collected from a sample of 118 inpatients at a public hospital in Spain. Ethical considerations: Informed consent from participants and ethical approval was obtained from a regional Clinical Research Ethics Committee. Findings: Ordinal Cronbach’s alphas were 0.966 for Individualized Care Scale-patient subscale A and 0.969 for Individualized Care Scale-patient subscale B. The polychoric correlation between each item and the subscale ranged between 0.653–0.874 and 0.604–0.916, respectively. The exploratory factor analysis revealed a three-factor solution. Personal life situation explained relatively large amounts of the variance. Goodness of fit index showed a good fit for the model. Discussion: This study confirms three factors underlining the individualized care concept, but some differences were found in the load of the factors, such as the relevance of “personal life situation” subscale, that need further research. Conclusion: The Spanish version of the Individualized Care Scale-patient is reliable, valid, user-friendly, and suitable to be used in Spanish-speaking countries showing satisfactory properties. This instrument may help managers better understand and develop areas in which patients perceive lower individualized care received and the factors influencing it. Such key information will help ensure the right of the patient to be respected as an individual. (shrink)

Although informed consent is an integral part of clinical practice, its current doctrine remains mostly a matter of law and mainstream ethics rather than empirical research. There are scarce empirical data on patients’ perceived purpose of informed consent, which may include administrative routine/courtesy gesture, simple honest permission, informed permission, patient-clinician shared decision-making, and enabling patient’s self decision-making. Different purposes require different processes.

Healthcare provision, like many other sectors of society, is undergoing major changes due to the increased use of data-driven methods and technologies. This increased reliance on big data in medicine can lead to shifts in the norms that guide healthcare providers and patients. Continuous critical normative reflection is called for to track such potential changes. This article presents the results of an interview-based study with 20 German and Swiss experts from the fields of medicine, life science research, informatics (...) and humanities of digitalisation. The aim of the study was to explore expert opinions regarding current challenges and opportunities related to data-driven medicine and medical research and to provide a methodological framework for empirically grounded, continuous normative reflection. To this end, we developed a heuristic tool to map and structure empirical findings for normative analysis. Using this tool, our interview material points to a polarisation between individualistic and collectivistic orientated argumentations among experts. The study shows that a multilevel analysis is required to deal with complex normative implications of data-driven approaches in medical research and healthcare. (shrink)

Increasing adoption of electronic health records in hospitals provides new opportunities for patient data to support public health advances. Such learning healthcare models have generated ethical debate in high-income countries, including on the role of patient and public consent and engagement. Increasing use of electronic health records in low-middle income countries offers important potential to fast-track healthcare improvements in these settings, where a disproportionate burden of global morbidity occurs. Core ethical issues have been raised around the role (...) and form of information sharing processes for learning healthcare systems, including individual consent and individual and public general notification processes, but little research has focused on this perspective in low-middle income countries. We conducted a qualitative study on the role of information sharing and governance processes for inpatient data re-use, using in-depth interviews with 34 health stakeholders at two public hospitals on the Kenyan coast, including health managers, providers and researchers. Data were collected between March and July 2016 and analysed using a framework approach, with Nvivo 10 software to support data management. Most forms of clinical data re-use were seen as an important public health good. Individual consent and general notification processes were often argued as important, but contingent on interrelated influences of the type of data, use and secondary user. Underlying concerns were linked to issues of patient privacy and autonomy; perceived risks to trust in health systems; and fairness in how data would be used, particularly for non-public sector re-users. Support for engagement often turned on the anticipated outcomes of information-sharing processes, as building or undermining trust in healthcare systems. As reported in high income countries, learning healthcare systems in low-middle counties may generate a core ethical tension between supporting a public good and respecting patient autonomy and privacy, with the maintenance of public trust acting as a core requirement. While more evidence is needed on patient and public perspectives on learning healthcare activities, greater collaboration between public health and research governance systems is likely to support the development of efficient and locally responsive learning healthcare activities in LMICs. (shrink)

The rapid dynamics of COVID-19 calls for quick and effective tracking of virus transmission chains and early detection of outbreaks, especially in the “phase 2” of the pandemic, when lockdown and other restriction measures are progressively withdrawn, in order to avoid or minimize contagion resurgence. For this purpose, contact-tracing apps are being proposed for large scale adoption by many countries. A centralized approach, where data sensed by the app are all sent to a nation-wide server, raises concerns about citizens’ (...) privacy and needlessly strong digital surveillance, thus alerting us to the need to minimize personal data collection and avoiding location tracking. We advocate the conceptual advantage of a decentralized approach, where both contact and location data are collected exclusively in individual citizens’ “personal data stores”, to be shared separately and selectively, voluntarily, only when the citizen has tested positive for COVID-19, and with a privacy preserving level of granularity. This approach better protects the personal sphere of citizens and affords multiple benefits: it allows for detailed information gathering for infected people in a privacy-preserving fashion; and, in turn this enables both contact tracing, and, the early detection of outbreak hotspots on more finely-granulated geographic scale. The decentralized approach is also scalable to large populations, in that only the data of positive patients need be handled at a central level. Our recommendation is two-fold. First to extend existing decentralized architectures with a light touch, in order to manage the collection of location data locally on the device, and allow the user to share spatio-temporal aggregates—if and when they want and for specific aims—with health authorities, for instance. Second, we favour a longer-term pursuit of realizing a Personal Data Store vision, giving users the opportunity to contribute to collective good in the measure they want, enhancing self-awareness, and cultivating collective efforts for rebuilding society. (shrink)

Personal health technologies such as apps and wearables that generate health and behavior data close to the individual patient are envisioned to enable personalized healthcare - and self-care. And yet, they are consumer devices. Proponents of these devices presuppose that measuring will be helpful, and that data will be meaningful. However, a growing body of research suggests that self-tracking data does not necessarily make sense to users. Drawing together data studies and digital health research, (...) we aim to further research on data ambivalence, a term we use to refer to the ambiguities and uncertainties people experience when interpreting their own data, as well as the critical obligation towards cultivating ethically sound uses and responses to such data in context. We develop the relationship between data, interpretation, and context as a central theoretical and practical problem in the datafication of healthcare. We then show how interpretation and context matter for data ambivalence through an empirical study of heart patients with an implanted advanced pacemaker who were offered a Fitbit wristband for self-tracking as part of a research project. We argue that the hope, anxiety, and doubt connected to the promise and accuracy of data are tempered by the context and purpose of self-tracking, and by individual circumstances. Finally, we link the findings on context-sensitivity in data interpretation to questions about response-ability in cloud-based care infrastructures. We discuss the ethical dilemmas associated with the use of commercial wellness-technologies in healthcare, and with researching such emerging practices. (shrink)

The practice of modern craniomaxillofacial surgery has been defined by emergent technologies allowing for the acquisition, storage, utilization, and transfer of massive amounts of sensitive and identifiable patient data. This alone has thrust providers into an unlikely and unprecedented role as the stewards of vast databases of digital information. This data powers the potent surgical tool of virtual surgical planning, a method by which craniomaxillofacial surgeons plan and simulate procedural outcomes in a digital environment. Further complicating this (...) new terrain is the involvement of third‐party contractors—a necessary presence in bringing raw data to bear in the office, virtual space, and operating room. The individual privileges and responsibilities of patients, providers, and vendors towards data are situated within the most recent U.S. court rulings and regulations. This paper offers guidance for overseeing the safe and responsible transfer to third‐party contractors, and provides suggestions for negotiating the trinary relationship between physicians, their patients, and the vendors offering this transformative technology. (shrink)

Background: Organ donation and transplantation have made it possible to both save life and to improve the quality of life for a large number of patients. In the last years there has been an increasing gap between the number of patients who need organs and organs available for transplantation, and the focus worldwide has been on how to meet the organ shortage. This also rises some ethical challenges. Objective: The objective of this study was to explore healthcare professionals' experience of (...) ethics related to care and interaction with critically ill patients with severe brain injuries and their families. Research design: A hermeneutic phenomenological approach was used to explore the participants' experiences. Methods for collecting data were a combination of participant observations and in-depth interviews. Participants and research context: Two ICUs in a Norwegian university hospital were recruited for data collection. A total of 12 cases were observed, and 32 of the healthcare professionals involved were interviewed. Ethical considerations: The study was approved by the Regional Committee for Research Ethics. Permission to the study in the ICUs was obtained from the Chief Physician in the two ICUs respectively. The right of the participants was ensured by written, voluntary, and informed consent. Findings: From the thematic analysis, a structure of the participants' experiences emerged as a process. While the patients' condition was clarified through phases of prognostic ambiguity, gradual clarification and prognostic certainty, interaction with the families was characterized by ambiguity that involved withholding. The prognostic process had a great impact on how the healthcare professionals interacted with the family. The interaction challenged the participants' caring values in various ways and captured an important structure in their experiences of the ethical interaction with the patients' families. These challenges distinguish caring for families in donation situations from caring for relatives of critically ill patients in general. Discussion: In the discussion we have illuminated how professional ethics may be threatened by more pragmatic and utilitarian arguments contained in regulations and transplant act. Conclusion: Ethical questions should be discussed more both in educations of healthcare professionals and in clinical practice. (shrink)

Background: Biomedical science is producing an avalanche of data about risk factors, often with a small predictive value, associated with a broad diversity of diseases. Prevention and screening are increasingly moving from public health into the clinic. Therefore, the question of which risk factors to investigate and disclose in the individual patient, becomes ethically increasingly urgent. In line with Wilson and Jungner's public health-related 10 principles for screening, it seems crucial to distinguish important from unimportant health risks.Aim: (...) to explore the ways in which clinicians distinguish important from unimportant health risks.Methods: We interviewed 36 respondents (gastroenterologists and gynaecologists/obstetrics) in 5 focus group interviews and 15 open in-depth interviews on their interpretation of what makes a health risk important.Results: Physicians primarily interpreted importance as the severity of the possible harm, less often its probability. Possibilities of prevention or reassurance strongly influenced their judgment on importance.Discussion: It is not likely that interpreting ‘important’ as ‘severe’ will help in differentiating meaningful from meaningless risk knowledge. A more fundamental change in our ways of dealing with risk may be called for. We discuss existing literature on resilience as an alternative way to deal with risk. Balancing prevention and risk reduction with resilience could be a fruitful direction. (shrink)

This article examines how digital epidemiology and eHealth coalesce into a powerful health surveillance system that fundamentally changes present notions of body and health. In the age of Big Data and Quantified Self, the conceptual and practical distinctions between individual and population body, personal and public health, surveillance and health care are diminishing. Expanding on Armstrong’s concept of “surveillance medicine” to “quantified self medicine” and drawing on my own research on the symbolic power of statistical constructs in medical (...) encounters, this article explores the impact of digital health surveillance on people’s perceptions, actions and subjectivities. It discusses the epistemic confusions and paradoxes produced by a health care system that increasingly treats patients as risk profiles and prompts them to do the same, namely to perceive and manage themselves as a bundle of health and security risks. Since these risks are necessarily constructed in reference to epidemiological data that postulate a statistical gaze, they also construct or make-up disembodied “individuals on alert”. (shrink)

When accessing healthcare services, LGBT+ individuals are often exposed to segregating and marginalizing discourses. Knowledge about how such experiences are reflected in the moral world of LGBT+ individuals living in Turkey is limited. This study examined LGBT+ individuals’ lived experiences when utilizing healthcare services. The findings are discussed in terms of moral discourses related to LGBT+ individuals’ gender identity and sexual orientation. A qualitative field study was conducted using semi-structured interviews with fifty-five LGBT+ individuals from Turkish cities who were in (...) contact with various non-governmental organizations that conduct studies on gender identity and sexual orientation. A questionnaire was administered with items on participants’ demographic information, experiences, behavioural patterns, and knowledge regarding healthcare services. The data were analysed thematically. The findings were evaluated within the framework of “access to healthcare service” theme related to “healthcare service demand” context. Additionally, the “interaction with physicians” theme was addressed in the context of “physician–patient/counselee relationship.” LGBT+ individuals state that they are exposed to stigmatizing and segregating discourses by healthcare professionals, which might pose an obstacle for adaptive health-seeking behaviours. These results suggest that physicians’ professional approach has a considerable influence on LGBT+ individuals’ capacity for utilizing healthcare services. (shrink)

Background: Individualized care is closely related to the fulfillment of nurses’ ethical responsibilities regarding the provision of healthcare as well as having a strong foundation in the philosophy of nursing. Objective: This study aimed to determine the association of job satisfaction and burnout with individualized care perceptions in nurses working at a university hospital located in the Central Black Sea region of northern Turkey. Research design: A cross-sectional correlational survey design. Participants and research context: The study was conducted between 15 (...) February 2017 and 15 August 2017 with 419 nurses working at a public university hospital located in Samsun. Data were collected using an information form, the Individualized Care Scale-Nurse Version, the Minnesota Job Satisfaction Scale, and the Maslach Burnout Inventory. The Mann–Whitney U test, Kruskal–Wallis test and Spearman Correlation were used. Ethical considerations: Ethical approval for the study was obtained from the Ondokuz Mayıs University Clinical Studies Board of Ethics. Oral informed consent was taken from the participants. Findings: There was a significant positive relationship between the total Individualized Care Scale-A Nurse Version score and the General Satisfaction subscale score of the Minnesota Job Satisfaction Scale (r = 0.121, p < 0.05). The total Individualized Care Scale-A Nurse Version score increased as the General Satisfaction subscale score of the Minnesota Job Satisfaction Scale increased. There was a significant negative relationship between the total Individualized Care Scale-B Nurse Version score and the Desensitization (r = –0.143, p < 0.01) and Personal Achievement subscale scores of the Maslach Burnout Inventory (r = –0.182, p < 0.01). The Desensitization and Personal Achievement subscale scores of the Maslach Burnout Inventory increased as the total Individualized Care Scale-B Nurse Version score decreased. Discussion: Factors associated with the individualized care perceptions of nurses, such as job satisfaction and burnout levels and factors related to personal life and worklife should be taken into consideration. Also in order to increase job satisfaction and motivation in nurses, personal preferences regarding the service they want to work at should be taken into account. Conclusion: Nurses with lower burnout and higher job satisfaction were found to have higher individualized care perceptions and to support the individuality of patients in care applications. It is important to consider work-related factors associated with individualized care perceptions, job satisfaction, and burnout in nurses. (shrink)

Massive amounts of data are collected and stored on a routine basis in virtually all domains of human activities. Such data are potentially useful to biomedicine. Yet, access to data for research purposes is hindered by the fact that different kinds of individual-patient data reside in disparate, unlinked silos. We propose that data cooperatives can promote much needed data aggregation and consequently accelerate research and its clinical translation. Data cooperatives enable direct (...) control over personal data, as well as more democratic governance of data pools. This model can realize a specific kind of data economy whereby citizens and communities are empowered to steer data use according to their motivations, preferences, and concerns. Policy makers can promote this model by recognizing citizens’ rights to access and to obtain a copy of their own data, and by funding distributed data infrastructures piloting new data aggregation models. (shrink)

When making substituted judgments for incapacitated patients, surrogates often struggle to guess what the patient would want if they had capacity. Surrogates may also agonize over having the (sole) responsibility of making such a determination. To address such concerns, a Patient Preference Predictor (PPP) has been proposed that would use an algorithm to infer the treatment preferences of individual patients from population-level data about the known preferences of people with similar demographic characteristics. However, critics have suggested (...) that even if such a PPP were more accurate, on average, than human surrogates in identifying patient preferences, the proposed algorithm would nevertheless fail to respect the patient’s (former) autonomy since it draws on the ‘wrong’ kind of data: namely, data that are not specific to the individual patient and which therefore may not reflect their actual values, or their reasons for having the preferences they do. Taking such criticisms on board, we here propose a new approach: the Personalized Patient Preference Predictor (P4). The P4 is based on recent advances in machine learning, which allow technologies including large language models to be more cheaply and efficiently ‘fine-tuned’ on person-specific data. The P4, unlike the PPP, would be able to infer an individual patient’s preferences from material (e.g., prior treatment decisions) that is in fact specific to them. Thus, we argue, in addition to being potentially more accurate at the individual level than the previously proposed PPP, the predictions of a P4 would also more directly reflect each patient’s own reasons and values. In this article, we review recent discoveries in artificial intelligence research that suggest a P4 is technically feasible, and argue that, if it is developed and appropriately deployed, it should assuage some of the main autonomy-based concerns of critics of the original PPP. We then consider various objections to our proposal and offer some tentative replies. (shrink)

BackgroundThe SARS-CoV-2 pandemic has highlighted once more the great need for comprehensive access to, and uncomplicated use of, pre-existing patient data for medical research. Enabling secondary research-use of patient-data is a prerequisite for the efficient and sustainable promotion of translation and personalisation in medicine, and for the advancement of public-health. However, balancing the legitimate interests of scientists in broad and unrestricted data-access and the demand for individual autonomy, privacy and social justice is a great (...) challenge for patient-based medical research.MethodsWe therefore conducted two questionnaire-based surveys among North-German outpatients (n = 650) to determine their attitude towards data-donation for medical research, implemented as an opt-out-process.ResultsWe observed a high level of acceptance (75.0%), the most powerful predictor of a positive attitude towards data-donation was the conviction that every citizen has a duty to contribute to the improvement of medical research (> 80% of participants approving data-donation). Interestingly, patients distinguished sharply between research inside and outside the EU, despite a general awareness that universities and public research institutions cooperate with commercial companies, willingness to allow use of donated data by the latter was very low (7.1% to 29.1%, depending upon location of company). The most popular measures among interviewees to counteract reservations against commercial data-use were regulation by law (61.4%), stipulating in the process that data are not sold or resold (84.6%). A majority requested control of both the use (46.8%) and the protection (41.5%) of the data by independent bodies.ConclusionsIn conclusion, data-donation for medical research, implemented as a combination of legal entitlement and easy-to-exercise-right to opt-out, was found to be widely supported by German patients and therefore warrants further consideration for a transposition into national law. (shrink)

Individuals with chronic spinal cord injury (CSCI) require complex and lengthy health services based on ethical philosophy. The virtue character that is most relevant to the egalitarian concept is fairness. The aim of the study is whether the character of fairness becomes the character of a doctor serving individuals with CSCI. It is a mixed method cross-sectional explanatory study, with questionnaires sent to doctors and individuals with CSCI, interviews with doctors, and healthcare system field observation. Sixty-two doctors and 33 patients (...) with CSCI participated in the study. The virtues most frequently chosen by doctors were love, gratitude, spirituality, zest, fairness, and kindness. The CSCI patients’ views regarding doctors’ characters were a postponement of personal interest, compassion, and loyalty to trust. All interviewed doctors indicated that they supported more than five of the 24 virtues. Doctors serve with ethical principles of virtue, even though the rewards received are inadequate. In fact, the use of health services by CSCI is still limited. Virtue ethics, especially the character of fairness, is necessary as a base of positive relationships between doctors and patients, to achieve equality of benefits for CSCI patients. Data obtained that the doctors’ character of fairness is still not the main choice. (shrink)

Introduction The major burden of the COVID-19 pandemic has been mainly on healthcare workers (HCWs) and as a result many of them have been afflicted with the disease thus far. -/- Purpose The present study was an effort to investigate Tehran University of Medical Sciences HCWs' experiences of COVID-19 during the pandemic in Tehran, Iran. -/- Methods This study is essentially a conventional qualitative content analysis. Twenty-six HCWs (including 7 physicians, 16 nurses, and 3 physiotherapists) were purposefully selected to participate (...) in the study. The data were collected from April 2020 to January 2021 through semi-structured face-to-face interviews. The interviews were transcribed and then analyzed based on the Graneheim and Lundman method using MAXQDA 12. -/- Results Based on the qualitative content analysis which resulted in 364 initial codes, three themes and eight subthemes were extracted. The extracted themes were “support,” “control,” and “improvement.” -/- Conclusions HCWs are in close contact with COVID-19 patients as part of their professional careers and the provision of quality patient care in times of crises is unattainable unless HCWs enjoy support and their own health is maintained. Making institutional, national, and international preparations for their protection is an obligation. (shrink)

Background Big data and AI applications now play a major role in many health contexts. Much research has already been conducted on ethical and social challenges associated with these technologies. Likewise, there are already some studies that investigate empirically which values and attitudes play a role in connection with their design and implementation. What is still in its infancy, however, is the comparative investigation of the perspectives of different stakeholders. Methods To explore this issue in a multi-faceted manner, we (...) conducted semi-structured interviews as well as focus group discussions with patients and clinicians. These empirical methods were used to gather interviewee’s views on the opportunities and challenges of medical AI and other data-intensive applications. Results Different clinician and patient groups are exposed to medical AI to differing degrees. Interviewees expect and demand that the purposes of data processing accord with patient preferences, and that data are put to effective use to generate social value. One central result is the shared tendency of clinicians and patients to maintain individualistic ascriptions of responsibility for clinical outcomes. Conclusions Medical AI and the proliferation of data with import for health-related inferences shape and partially reconfigure stakeholder expectations of how these technologies relate to the decision-making of human agents. Intuitions about individual responsibility for clinical outcomes could eventually be disrupted by the increasing sophistication of data-intensive and AI-driven clinical tools. Besides individual responsibility, systemic governance will be key to promote alignment with stakeholder expectations in AI-driven and data-intensive health settings. (shrink)

Background: Both anxiety and depression in family caregivers of advanced cancer patients are common, and they have a negative influence on both the FCs and the patients. Some studies suggested that a variety of interventions could alleviate the psychological symptoms of FCs. However, there is no consensus on much more effective methods for intervention, and relatively high-quality research is blank in psychological problems of these population in China. The validity of mindfulness-based stress reduction and psychological consultation guided by the needs (...) assessment tool in the psychological status of caregivers will be compared in this study to select a more suitable intervention for the FCs of advanced cancer patients in China.Methods and Analysis: A randomized N-of-1 trial would be conducted at the Cancer Hospital, Chinese Academy of Medical Sciences. Fifty eligible FCs of advanced cancer patients will be recruited, and all will receive three cycles of psychological intervention treatment, with each cycle including both of MBSR and psychological consultation guided by the NST. MBSR and psychological consultation guided by the NST will be compared with each other in each cycle, and the intervention sequence will be based on the random number table generated after the informed consent has been completed. Each treatment period is 2 weeks, and the interval between different treatment cycles or treatment periods is 1 week. The self-reported scales are measured at the beginning and end of each treatment period, including the Self-Rating Anxiety Scale, the Self-Rating Depression Scale, Distress Thermometer, Zarit Burden Interview, Chinese version of the Medical Outcomes Study 12-item Short Form, and Family Carer Satisfaction with Palliative Care scale.Dissemination: The protocol of the study was approved by the Institutional Review Board of the Ethical Committee of the Cancer Hospital, Chinese Academic of Medical Science. The results will be published in a peer-reviewed medical journal. The study is registered at Chinese Clinical Trials Registry with the trial registration number chiCTR2000033707. This study employs an innovative methodological approach on the effectiveness of MBSR and psychological consultation guided by the NST for psychological status of FCs of advanced cancer patients. The findings of the study will be helpful to provide high-quality evidence-based medical data for psychological intervention of FCs of advanced cancer patients, and guide clinicians on best quality treatment recommendations. (shrink)

The aim of this qualitative study was to gain an understanding of the meaning that community psychiatric nurses impart to their everyday interactions with patients in depot neuroleptic treatment situations. Nine experienced community psychiatric nurses were interviewed using semistructured, open-ended questions. Data analysis was by the phenomenological descriptive method according to Giorgi. Four themes were identified, highlighting aspects of the moral meaning of treating patients with depot neuroleptics: (1) ‘benevolent justification’ occurs when nurses perceive that the patient’s welfare (...) is at stake; (2) ‘inability to advocate the patients’ best interest’ occurs when nurses feel they are at a disadvantage; (3) ‘accommodative interactions’ occur when nurses are able to respond to a patient’s expressed needs; and (4) ‘acceptable advocacy’ occurs when physicians are sensitive to nurses’ suggestions on patients’ treatment. The findings indicate that treatment care planning involving both patients and nurses is essential to enhance patients’ autonomy, which is a precondition for satisfactory interactions. This phenomenological study describes the meaning that nurses give to administering depot neuroleptic injections to patients in the context of community psychiatric clinics. The phenomenon of concern was identified as the moral aspect in the interactions with individual patients in the treatment situation. (shrink)

Background Individual physicians and physician-associated factors may influence patients’/surrogates’ autonomous decision-making, thus influencing the practice of do-not-resuscitate orders. The objective of this study was to examine the influence of individual attending physicians on signing a DNR order. Methods This study was conducted in closed model, surgical intensive care units in a university-affiliated teaching hospital located in Northern Taiwan. The medical records of patients, admitted to the surgical intensive care units for the first time between June 1, 2011 and (...) December 31, 2013 were reviewed and data collected. We used Kaplan–Meier survival curves with log-rank test and multivariate Cox proportional hazards models to compare the time from surgical intensive care unit admission to do-not-resuscitate orders written for patients for each individual physician. The outcome variable was the time from surgical ICU admission to signing a DNR order. Results We found that each individual attending physician’s likelihood of signing do-not-resuscitate orders for their patients was significantly different from each other. Some attending physicians were more likely to write do-not-resuscitate orders for their patients, and other attending physicians were less likely to do so. Conclusion Our study reported that individual attending physicians had influence on patients’/surrogates’ do-not-resuscitate decision-making. Future studies may be focused on examining the reasons associated with the difference of each individual physician in the likelihood of signing a do-not-resuscitate order. (shrink)

This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants to (...) be permitted access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)

The Patient Preference Predictor (PPP) is intended to improve treatment decision making for incapacitated patients. The PPP would collect information about the treatment preferences of people with different demographic and other characteristics. It could be used to indicate which treatment option an individual patient would be most likely to prefer, based on data about the preferences of people who resemble the patient. The PPP could be incorporated into existing US law governing treatment for incapacitated patients, (...) although it is unclear whether it would be classified as evidence of a specific patient’s preferences or those of a reasonable person sharing certain characteristics with the patient. Ethical concerns about the quality and significance of PPP choices could influence legal decision makers’ views of the PPP. (shrink)

ABSTRACT This paper is intended to stimulate debate amongst stakeholders in the international research community on the topic of returning individual genetic research results to study participants. Pharmacogenetics and disease genetics studies are becoming increasingly prevalent, leading to a growing body of information on genetic associations for drug responsiveness and disease susceptibility with the potential to improve health care. Much of these data are presently characterized as exploratory (non‐validated or hypothesis‐generating). There is, however, a trend for research participants (...) to be permitted access to their personal data if they so choose. Researchers, sponsors, patient advocacy groups, ethics committees and regulatory authorities are consequently confronting the issue of whether, and how, study participants might receive their individual results. Noted international ethico‐legal guidelines and public policy positions in Europe and the United States are reviewed for background. The authors offer ‘Points‐to‐Consider’ regarding returning research results in the context of drug development trials based on their knowledge and experience. These considerations include: the clinical relevance of data, laboratory qualifications, informed consent procedures, confidentiality of medical information and the competency of persons providing results to participants. The discussion is framed as a benefit‐to‐risk assessment to balance the potential positive versus negative consequences to participants, while maintaining the integrity and feasibility of conducting genetic research studies. (shrink)

Genetic information is widely thought to pose unique risks of reidentifying individuals. Genetic data reveals a great deal about who we are and, the standard view holds, should consequently be treated differently from other types of data. Contrary to this view, we argue that the dangers of reidentification for genetic and nongenetic data—including health, financial, and consumer information—are more similar than has been recognized. Before different requirements are imposed around sharing genetic information, proponents of the standard view (...) must show that they are in fact necessary. We further argue that the similarities between genetic and nongenetic information have important implications for communicating risks during consent for health care and research. While patients and research participants need to be more aware of pervasive data‐sharing practices, consent forms are the wrong place to provide this education. Instead, health systems should engage with patients throughout patient care to educate them about data‐sharing practices. (shrink)

Some transgender and nonbinary people undergo phalloplasty and/or metoidioplasty as part of their medical transition process. Across surgical disciplines, a variety of resources are used to assist patients who are preparing for surgeries, including educational materials, workshops, peer support, and lifestyle changes. For gender-affirming surgeries, patients undergoing assessments to discern whether they are ready to undergo the surgery, and to assist them in achieving preparedness when needed. Little research investigates what resources are useful in helping patients to feel prepared to (...) undergo phalloplasty or metoidioplasty, and how assessments and resources can promote patient autonomy in the process. Respect for patient autonomy is one of the central tenets of ethical healthcare, yet historically, scholarship related to pre-surgical assessments for gender-affirming surgery has focused determining the ideal surgical candidate rather than respecting patient autonomy and ascertaining individual patient needs. This study sought to fill this gap by utilizing data from PROGRESS (Patient-Reported Outcomes of Genital Reconstruction and Experiences of Surgical Satisfaction), a cross-sectional, community-based survey of trans and nonbinary adults from the United States of America and Canada who had undergone one or more of these surgeries. Results revealed most participants (86%, n = 186) felt prepared to undergo surgery, though the majority of our sample (53%, n = 105) did not find referral letter assessments to be helpful. Peer support such as online resources/blogs were rated as highly useful, along with surgical consults. In a multivariable logistic regression, higher perceived preparedness was associated with identifying as queer (inclusive of gay, bi and pansexual compared to being straight), and feeling that one’s assessment process was useful (as opposed to not useful). Type of assessment was not significantly associated with preparedness; therefore, what is most useful when preparing for surgery may vary across individuals. Healthcare professionals who interact with preparing patients should develop new or utilize existing resources to assist patients in identifying their preparation needs and achieving preparedness. Our data supports assessments that center surgical care planning rather than assessing level of gender dysphoria. Future longitudinal research could further refine which assessment processes are most effective in helping patients who are preparing for these surgeries. Assessments should ensure that patients are appropriately prepared to undergo and recover from surgery through a robust process of informed consent. (shrink)

Background: Dignity is seen as an important but complex concept in the healthcare context. In this context, the discussion of dignity includes concepts of other ethical principles such as autonomy and privacy. Patients consider dignity to cover individuality, patient’s feelings, communication, and the behavior of healthcare personnel. However, there is a lack of knowledge concerning the realization of patients’ dignity in hospital care and the focus of the study is therefore on the realization of dignity of the vulnerable group (...) of patients with stroke. Aim: The aim of the study was to create a theoretical construct to describe the dignity realization of patients with stroke in hospital care. Research design and participants: Patients with stroke (n = 16) were interviewed in 2015 using a semi-structured interview containing open questions concerning dignity. The data were analyzed using constant comparison of Grounded Theory. Ethical considerations: Ethical approval for the research was obtained from the Ethics Committee of the University. The permission for the research was given by the hospital. Informed consent was obtained from participants. Findings: The “Theory of Dignity Realization of Patients with Stroke in Hospital Care” consists of a core category including generic elements of the new situation and dignity realization types. The core category was identified as “Dignity in a new situation” and the generic elements as health history, life history, individuality and stroke. Dignity of patients with stroke is realized through specific types of realization: person-related dignity type, control-related dignity type, independence-related dignity type, social-related dignity type, and care-related dignity type. Discussion: The theory has similar elements with the previous literature but the whole construct is new. The theory reveals possible special characteristics in dignity realization of patients with stroke. Conclusion: For healthcare personnel, the theory provides a frame for a better understanding and recognition of how dignity of patients with stroke is realized. (shrink)

Patients with serious illnesses or injuries may decide to quit their medical treatment if they think paying the fees will put their families into destitution. Without treatment, it is likely that fatal outcomes will soon follow. We call this phenomenon “near-suicide”. This study attempted to explore this phenomenon by examining how the seriousness of the patient’s illness or injury and the subjective evaluation of the patient’s and family’s financial situation after paying treatment fees affect the final decision on (...) the treatment process. Bayesian Mindsponge Framework (BMF) analytics were employed to analyze a dataset of 1042 Vietnamese patients. We found that the more serious the illnesses or injuries of patients were, the more likely they were to choose to quit treatment if they perceived that paying the treatment fees heavily affected their families’ financial status. Particularly, only one in four patients with the most serious health issues who thought that continuing the treatment would push themselves and their families into destitution would decide to continue the treatment. Considering the information-filtering mechanism using subjective cost–benefit judgments, these patients likely chose the financial well-being and future of their family members over their individual suffering and inevitable death. Our study also demonstrates that mindsponge-based reasoning and BMF analytics can be effective in designing and processing health data for studying extreme psychosocial phenomena. Moreover, we suggest that policymakers implement and adjust their policies (e.g., health insurance) following scientific evidence to mitigate patients’ likelihood of making “near-suicide” decisions and improve social equality in the healthcare system. (shrink)

Patients in specialist mental healthcare services who are at risk of suicide may experience their struggles as existential in nature. Yet, research on meaning in life has been relatively scarce in suicidology. This qualitative study aimed to explore how patients at risk of suicide perceived their encounters with specialist healthcare professionals after a suicide attempt (SA), with special reference to meaning in life experiences. The study was conducted in specialised mental healthcare services in Norway. Data were collected via (...) class='Hi'>individual interviews with eight patients aged 20–75 years. Using a four-step procedure, the interviews were analysed by systematic text condensation. The participants understood their feelings of shame, self-contempt and challenging life experiences as contributing factors to their SA. They perceived that existential themes in relation to financial difficulties, shame and trauma were resolved, while issues associated with the SA, such as death, loss and beliefs, were given less attention. The participants were either ambivalent about continuing to live or wished to rebuild a meaningful life. Overall, their experiences of meaningfulness were hampered. Assisting patients with meaning in life experiences may help them alter their life interpretations and increase their ability to rebuild their lives as meaningful. The present study should be seen as a contribution to meaning-informed approaches in specialist mental healthcare services. More research is needed to equip healthcare personnel in their overall aims of preventing suicide and supporting patients at risk in their efforts to live a meaningful life. (shrink)

Objective Cluster randomised trial (CRT) investigators face challenges in seeking informed consent from individual patients (cluster members). This study examined associations between reporting of patient consent in healthcare CRTs and characteristics of these trials. Study design Consent practices and study characteristics were abstracted from a random sample of 160 CRTs performed in primary or hospital care settings that were published from 2000 to 2008. Multivariable logistic regression was used to examine associations between reporting of patient consent and (...) methodological characteristics, as well as publication features such as date and journal of publication. Results 82 (53.8%) of 160 studies reported obtaining informed consent from individual patients. Reporting of patient consent was independently and positively associated with: smaller cluster size, the evaluation of experimental interventions targeted at patients, data collection from individual patients, publication later than 2004 and publication in higher-impact journals. Conclusions Reporting of consent practices in published CRTs should be improved. Consent practices in published CRTs appear to be related to the type of interventions under study, as well as journal impact and trends in research ethics practices. These findings will inform best practices in trial conduct and ethics review, remediation of errors in consent practices and ethics review and the development of regulatory guidance for CRTs. (shrink)

Background: Heart failure is a major growing problem and affects not only patients but also their families and community networks and reduces the functional capacity of patients and impairs their social life. Research questions: This study was conducted to investigate relationship between illness-related worries and social dignity in patients with heart failure. Design: The study had a descriptive-analytic design, and data collection was carried out by means of two specific questionnaires. Participants and context: A total of 130 inpatients from (...) cardiac wards in hospitals affiliated with Tehran and Shahid Beheshti University of Medical Sciences participated. Ethical consideration: This study was approved by the Research Committee of Shahid Beheshti University of Medical Sciences. Results: The highest mean score of illness-related worries was attributed to the dimension of patient’s worry of physical–mental complications, and the least mean score was related to the dimension of the worry about the future of disease. The highest mean score of social dignity was associated with the dimension of social communication and support, and the least is attributed to the dimension of burden to others (economic). Pearson’s statistical test showed a significant correlation (r = 0.455, p < 0.05) between the score of illness-related worries and social dignity. Discussion: As the result of this study showed that reducing illness-related worries in patients with heart failure can improve their social dignity, using strategies to decrease worries and promote social dignity in these patients is recommended. Conclusion: This study affirms the importance of careful evaluation of individual patients to determine their needs related to dignity. We hope these results will help to promote actions by patient-care staff that honor and support patient dignity, resulting in benefits to patients and developing the quality of care based on human rights. (shrink)

This paper problematises the notions of public or common good as weighed against individual sovereignty in the context of medical research by focusing on genetic research. We propose the notion of collective good as the good of the particular collective in which the research was conducted. We conducted documentary and interview-based research with participant representatives and research leaders concerned with participant involvement in leading genetic research projects and around two recent genetic data controversies: the case of the UK (...) Wellcome Sanger Institute, accused of planning unauthorised commercialisation of African DNA samples, and the case of the company Genuity Science, which planned genetic research on brain tumour samples in Ireland with no explicit patient consent. We advocate for greater specificity in circumscribing the collective to which genetic research relates and for greater efforts in including representatives of this collective as research coleaders in order to enable a more inclusive framing of the good arising from such research. Such community-based participant cogovernance and coleadership in genetic research is vital especially when minorities or vulnerable groups are involved, and it centrally requires community capacity building to help collectives articulate their own notions of the collective good. (shrink)

Maintenance and promotion of patient dignity is an ethical responsibility of healthcare workers. The aim of this study was to investigate patient dignity and related factors in patients with heart failure. In this qualitative study, 22 patients with heart failure were chosen by purposive sampling and semi-structured interviews were conducted until data saturation. Factors related to patient dignity were divided into two main categories: patient/care index and resources. Intrapersonal features (inherent characteristics and individual beliefs) (...) and interpersonal interactions (communication, respect, enough information, privacy, and authority) were classified as components of the patient/care index category. Human resources (management and staff) and environmental resources (facilities and physical space) were classified as components of the resources category. The results will increase healthcare staff's understanding of patient dignity and its related factors, and provide information regarding the development of systems and processes that support patients in ways that are consistent with these values. (shrink)

The featured case discussion on the role of consent and individual autonomy in the PIP breast implant scandal raises interesting and important questions regarding the right of patients (and individuals in general) to decide whether to have their personal data included in medical registries and used for research. The fate of the National Breast Implant Registry, following the introduction of a policy that demanded formally recorded informed consent, is particularly enlightening. Combined with the (ex post) fact that reliable (...) and comprehensive data would have been useful in this specific case, it clearly illustrates the dangers of overemphasizing individual autonomy in observational research. The issue is timely, as the European Commission has recently proposed a new Data Protection Regulation (European Commission, 2012) that may have serious implications for registry based research. In this commentary, I will first discuss two aspects of the regulatory framework that arguably contribute to the problematic situation and then offer an alternative view on why requiring consent should not be the default position in this kind of research. (shrink)

ObjectiveThis systematic review aims to make a mixed comparison of interventions for kinesiophobia and individuals with musculoskeletal pain.MethodsA comprehensive search strategy was conducted in the database of PubMed, MEDLINE, and Web of Science with the inclusion criteria: randomized controlled design; patients with musculoskeletal pain as participants; treatments protocols of kinesiophobia as interventions or comparisons; the score of Tampa Scale Kinesiophobia as outcome measures. A network meta-analysis was used to synthesize the data after checking the model consistency. The risk of (...) bias was assessed by the Cochrane Collaboration Risk of Bias Assessment Tool.ResultsThirty-one studies were included in this review after a comprehensive search strategy with a low risk of bias and good consistency. According to the results of the network meta-analysis, a multi-modal treatment protocol had the highest probability to become the best choice in dealing with kinesiophobia caused by musculoskeletal pain, whereas psychological treatment protocols also showed a potentially positive effect on musculoskeletal pain-induced kinesiophobia.ConclusionMulti-modal protocols could be recommended as the preferred option when dealing with kinesiophobia caused by musculoskeletal pain. However, it is still worth mentioning that there are also potentially positive therapeutic effects of psychological interventions. Since the concept of kinesiophobia is based on the fear-avoidance model, the psychological mechanism should be paid enough attention to during treatment.Registration NumberCRD42021286450. (shrink)

Since the solution to many public health problems depends on research, it is critical for the progress and well-being for the patients that we can trust the scientific literature. Misconduct and poor laboratory practice in science threatens the scientific progress, leads to loss of productivity and increased healthcare costs, and endangers lives of patients. Data duplication may represent one of challenges related to these problems. In order to estimate the frequency of data duplication in life science literature, a (...) systematic screen through 120 original scientific articles published in three different cancer related journals [journal impact factor 20] was completed. The study revealed a surprisingly high proportion of articles containing data duplication. For the IF 20 journals, 25 % of the articles were found to contain data duplications. The IF 5–10 journal showed a comparable proportion. The proportion of articles containing duplicated data was comparable between the three journals and no significant correlation to journal IF was found. The editorial offices representing the journals included in this study and the individual authors of the detected articles were contacted to clarify the individual cases. The editorial offices did not reply and only 1 out of 29 cases were apparently clarified by the authors, although no supporting data was supplied. This study questions the reliability of life science literature, it illustrates that data duplications are widespread and independent of journal impact factor and call for a reform of the current peer review and retraction process of scientific publishing. (shrink)

Transtheoretical integrative decision-making models help clinicians to use patient factors that are known to predict outcomes in order to inform individualized treatment. Patient factors with a strong evidence base include: functional impairment, social support and interpersonal functioning, complexity and comorbidity, coping style, level of resistance, and subjective distress. Among those with binge-eating disorder (BED), patient factors have not been extensively characterized relative to norms or other clinical samples. We used an integrative decision-making model of these six domains (...) of patient factors related to patient outcomes to characterize a sample of 424 adult treatment-seeking patients with BED. Data were from medical charts, a demographics questionnaire, and validated psychometric scales. We then compared these data to published data from normative and other eating disorder (ED) samples. Results showed that the average patient with BED: (1) was significantly more functionally impaired compared to non-clinical norms but somewhat less impaired than other patients with ED, (2) demonstrated clinically significant problems in social support and interpersonal functioning, (3) presented with complex comorbid pathology and high levels of chronicity, (4) used a more internalizing coping style compared to the norm and other ED samples, (5) had low levels of resistance to interventions, and (6) experienced a moderately high level of subjective distress indicating good motivation for treatment. Corresponding recommendations to these findings are that the average patient with BED should be provided higher intensity treatment that is longer in duration, interpersonally-focused, directive in nature, and emphasizing self-reflection and insight. Despite the nomothetic nature of the findings, clinicians are encouraged to assess these patient domains in order to come to an ideographic case conceptualization and to tailor precision treatment to the individual patient with BED. (shrink)

One of the largest, oldest, and most interesting challenges in health care is the balancing act in which clinicians have generally uncontroversial duties both to individual patients and to communities. Physicians and nurses must — so we teach them — put patients first, and at the same time recognize that individuals are members of communities. Individuals affect the health of communities, and communities affect the health of individuals. Thus, the moral and professional duties that result are sometimes in conflict.Moreover, (...) the traditional, prosaic clinical encounter is evolving in an environment increasingly shaped by electronic health records, personal health records, pharmacogenomics and vast networks of data collection and storage for public health surveillance, human subjects research, health services evaluation, and comparative effectiveness research. Health information technology is changing everything. It would be perverse otherwise: imagine large amounts of data and information either ignored, missed, or collected and then ignored. (shrink)

Digital data help data scientists and epidemiologists track and predict outbreaks of disease. Mobile phone GPS data, social media data, or other forms of information updates such as the progress of epidemics are used by epidemiologists to recognize disease spread among specific groups of people. Targeting groups as potential carriers of a disease, rather than addressing individuals as patients, risks causing harm to groups. While there are rules and obligations at the level of the individual, (...) we have to reach a stage in the development of data analytics where groups are protected as entities. This chapter offers a deeper examination of harms to the groups. (shrink)

Background In recent years, patient advocacy has emerged as a prominent concept within healthcare. How nursing students decide what is best for their patients is not well understood. Objective The objective is to examine nursing students' views on doing what is best for patients during their clinical experiences and how they seek to establish patient interests when providing care. Research questions guiding the interview were as follows: (1) What are nursing students' perceptions of patient interests? (2) What (...) factors influence nursing students' perceptions of advocating for patient’s interests? Research design Qualitative descriptive research using thematic analysis. Participants and research context Data was collected through individual online interviews with nine nursing students with clinical experience. Ethical considerations The study was approved by the University Research Ethics Committee. Participants provided digital informed consent. Results The students asserted that they are able to understand the patients' interests by placing emphasis on the patients' needs. They believe that it is crucial to adopt a collaborative strategy for the provision of care to meet these requirements. In addition, some of them expressed concern over the most effective methods of advocating for the interests of patients. Three themes were identified. (1) Focussing on patient needs first, (2) taking a collective approach, and (3) learning how to advocate. Conclusions Students understand and value the ethical commitments associated with advocating for the patient's best interest by considering factors such as prioritising the patient's needs, adopting a strategy that involves everyone, and acquiring the ability to undertake the advocacy role. Additionally, nursing education strategies in clinical contexts require additional study to inspire students to do what is in their patient’s best interests. (shrink)

Much is known about the phenomenon of dignity, yet there is still a need for implementing this understanding in clinical practice. The main purpose of this study was to find out how persons suffering from multiple sclerosis experience and understand dignity and violation in the context of a rehabilitation ward. A phenomenological-hermeneutic approach was used to extract the meaningful content of narratives from 14 patients with multiple sclerosis. Data were collected by personal research interviews. The findings revealed three main (...) themes: (1) ‘invisibly captured in fatigue’; (2) ‘fighters’ law: one who does not ask will not receive’; and (3) ‘dignity is humanity’. The essence of the findings in this study is that dignity is humanity. According to the participants, dignity requires time and is experienced only in a context of empathy and mutual confidence. (shrink)

This dissertation is focused on the validity of “the data” that are collected in psychotherapy research for the purpose of evidencing treatment efficacy. In the ‘Evidence Based Treatment’ paradigm, researchers rely on the so-called ‘gold standard methodology’ to gather sound and trustworthy evidence, which increasingly influences the organization of mental health care worldwide. In the gold standard, data are collected by quantified self-report measures, to assess the presence and severity of symptoms before and after treatment. When the pre-post (...) difference is larger for a group of people that received the treatment of interest and a group of people who received no or an alternative treatment, the treatment of interest is called effective. In this methodological procedure, researchers tend to assume that when this gold standard methodology is conducted properly, “the data” will speak for themselves. However, when evidence is based on data, that evidence is principally limited by that data. In other words: output depends on input. That implies that when input is flawed, output will be flawed, even when the very best methods of analysis would be used. So what if “the data” yield validity issues despite being collected by validated measures? When “the data” do not straightforwardly evidence treatment effects, will the subsequent steps in the analysis of these data be enough to secure that the evidence in the end does evidence treatment efficacy? In this dissertation, the focus is turned to validity of “the data” that are concretely provided by patient-participants by scoring their own experienced symptoms in self-report questionnaires, in function of evidencing treatment efficacy. A series of empirical case studies were conducted to scrutinize how patient-participants in a randomized controlled psychotherapy study experienced the process of data collection, and how these experiences affected the data that they provided. Each of the studied patient-participants experienced a substantial effect of the questionnaire administration on their complaints. This impacted the level of complaints, but also changed the way in which the complaints were understood at all, and how patient-participants perceived themselves. Thus, rather than neutrally measuring symptoms, questionnaire administration changed the experienced complaints ‘performatively’, which turned measurement into a clinical intervention of its own. Consequently, what is measured cannot straightforwardly be called ‘treatment efficacy’, as it may be entangled with, enabled by or even obstructed by effects of measurement and research. Therefore, the act of measurement itself can pose a vital threat to the validity of “the data”. This way, the empirical case studies exhibited that data can yield validity problems despite the use of validated measures. Consequently, the validity of a measure as such is no guarantee for the validity of data. Nonetheless, in gold standard research, the data are straightforwardly taken as input for analyses of general treatment efficacy. The question is what happens with those validity issues on the level of individual data, when they pursue their journey towards becoming evidence. In this dissertation, it was argued that the validity issues are not sufficiently solved in the methodological steps after data collection, so when data are invalid in the beginning, these validity issues will simply become part of the data set that forms the input for analysis of the final evidence. This urges that validity issues should be solved on the level of individually provided data, as the validity issues will otherwise become inherent to “the data”. Put formally: valid data is a precondition for evidence in EBT. In conclusion, it is crucial for a sound evidence-base to scrutinize the validity of data in function of the overall goal and utility of the research. For this, it is important not to take “the data” as speaking for themselves, but to regard them as clinical narratives, which are framed in a specific format to be communicated between researcher and respondent in a research context. This emphasizes that the choice for a certain format determines what can be evidenced, so it is vital that these choices indeed allow for obtaining evidence that is useful and valid to serve the clinical goal of EBT. (shrink)

Chronic diseases represent the major illness burden of developed nations. A chronic disease databank system consists of parallel longitudinal data sets from diverse locations describing the courses of thousands of patients with chronic illness over many years. Illustrated by ARAMIS (The American Rheumatism Association Medical Information System), such data resources facilitate analysis of long term health outcomes and the factors associated with particular outcomes. A model for clinical investigation of contemporary disease is presented, based on the overwhelming prevalence (...) of chronic illness, the variability, complexity, and uniqueness of the individual patient course, the difficulties of traditional univariate reductionist approaches, and the time span required for study. In this model, data are systematically accrued and continually analyzed, and the data collected are gradually modified based upon evolving anticipation of future needs. The strategies underlying the development of ARAMIS are described, investigational results summarized, and future directions outlined. Keywords: ARAMIS, Chronic Disease Databanks, Prognosis, Health Outcomes CiteULike Connotea Del.icio.us What's this? (shrink)