The commentary discusses the importance of developing Universal Health Coverage strategies through the lens of complex systems framework that evaluates policies not only in terms of the final desired outcome but also as an interplay of disparate views among diverse actors in the system. This view also confers a degree of agency and autonomy on the individual actors, whether they be patients or healthcare workers, and necessitates the inclusion of bottom-up participatory process in the development of UHC policies and interventions. These are consistent with the Primary Health Care principles articulated in the 1978 Alma Ata Declaration and will need to be integrated into the health system development framework to achieve UHC. Ultimately, this approach would encourage the creation of a more cooperative and adaptive policy environment in which each actor is encouraged to collaborate and are nudged toward a desirable outcome rather than through coercive means.

The outbreak of the Covid-19 pandemic obliged us all to handle many dilemmas, some of which we took upon ourselves as philosophers, ethicists, doctors and nurses to discuss around four key ethical notions : responsibility, dignity, fairness and honouring death. The following collection of the symposium acts held online in May 2020 with the Paris Global Center of Columbia University and Columbia Global Centers, attempts to testify to the ongoing pandemic emergency and difficult challenges while evaluating whether the ethical principles in the official recommendations were able to meet the lived reality. Looking at accountability and consistency in regard to the context of exercise, it seemed equally important to examine, through an international exchange, whether the contextuality of Coronavirus across countries and cultures affected the ethical decision making processes. We hope that our discussion can serve as a resource for advanced care planning, helping medical providers and other specialists to consider the shared important aspects of medical ethics in times of great uncertainty.

Rationale, aims, and objectives: Portenoy and Foley’s 1986 landmark study “Chronic use of opioid analgesics in non-malignant pain: report of 38 cases” has been reproached for opening the floodgates of opioid prescribing for chronic non-cancer pain and the attendant harms. This influential article has been cited over 500 times in the scientific literature over the last four decades. This study seeks to understand the impact of Portenoy and Foley’s article on subsequent discussions and research about opioids. Methods: We conducted a multi-method bibliometric analysis of all citations of this article from 1986 through 2019 using quantitative relational and qualitative content analysis to determine how uses and interpretations of this case series and associated prescribing guidance have changed over time, in relationship to the evolution of the North American opioid crises. Results: Using time series analysis, we identified three periods with distinct interpretations and uses of the index study. In the first “exploration” period (1986-1996), the index study was well-received by the scientific community and motivated further study of the effects of opioids. In the second “implementation” period (1997-2003, coinciding with the release of OxyContin®), this study was used as evidence to support widespread prescribing of opioid analgesics, even while it was recognized that long-term effects had not yet been evaluated. The third “reassessment” period (2004-2019) focused on how opioid-related harms had been overlooked, and in many cases these harms were directly attributed to this study. Conclusion: These changes in interpretation demonstrate shifting currents of the use and mobilization of evidence regarding pain and opioids, and how these currents both impact and are impacted by clinical practices and major sociohistorical phenomena such as the opioid crisis. Researchers and clinicians must account for these shifting dynamics when developing and interpreting scientific knowledge, including in the form of clinical practice guidelines.

Rationale and aims: Precision medicine (PM) raises a key question: How can we know what works when the number of people with a health problem becomes small or one (n=1)? We here present a formative case from Norway. The Norwegian Board of Health Supervision was faced with a cancer patient, who had improved after treatment with a drug in the private health sector but was refused continued treatment in the public health service due to lack of clinical trial evidence. The Board overturned this decision, arguing that the drug had been unambiguously documented to work in the individual case. We aim to provide an in-depth analysis of this case and The Board´s decision and thereby to illustrate and elucidate key epistemological and ethical issues and developments in PM. Method: We provide our analysis and discussion using tools of critical thinking and concepts from philosophy of science and medicine such as uncertainty, evidence, forms of inference and causation. We also examine the case in the light of the history of evidence-based medicine (EBM). Results and discussion: The case reflects an epistemological shift in medicine where PM puts greater emphasis on evidence that arises in individual patients after the treatment is provided over preexisting population-based evidence. PM may rely more heavily on abduction to decide what works and qualitative, rather than quantitative judgments. The case also illustrates a possible shift in the concept of causation from regularity accounts to mechanistic and process accounts. We discuss ethical implications of a shift from more “traditional” to “personalized EBM”. Conclusion: A framework that is more based on abductions and evidence arising in the individual case has problems in creating quantifiable, reliable, and generalizable evidence, and in promoting transparency and accountability. PM currently lacks clear criteria for deciding what works in an individual, posing ethical challenges.

Sturmberg and Martin in 2020 argue that Universal Health Care (UHC) is mainly about financing and Primary Health Care (PHC) is about the right care at the right time to ensure health. They maintain the World Health Organisation (WHO) has recently sent the wrong message about the “pillars” of PHC in their relationship to UHC. An understanding of political economy is required in order to come to terms with the bases of PHC and the fundamentals of UHC, that dealing with inequities is not only an economic issue but fundamentally a political issue. Neoliberal decision making can enhance inequities in society. Two chronic health conditions, diabetes and multiple sclerosis are examples of conditions that lead to costly and debilitating consequences for patients but also lead to substantial economic costs in terms of lost workforce participation and lost productivity. These cases demonstrate the socio-political issues involved in the management of care for a number of illnesses. The upsurge of COVID–19 has placed an enormous strain on health and broader social and economic resources and challenged the pretext of UHC as health for all: substantial differences in equity and political commitment have emerged. Sturmberg and Martin argue that the joining of UHC and PHC needs leadership which involves local communities and resourcing. PHC is a changing system based on power relationships involving funders and the health community. In Australia as in several countries out of pocket costs have grown rapidly and have affected access for some groups to PHC and have challenged the pretext of equity in UHC. In the context of PHC and UHC we support the position that health for all goes beyond healthcare for all, to embrace healthy lives promoting wellbeing.

The Universal Health (UHC) movement in its latest iteration, has adopted key objectives of Primary Health Care (PHC). This is a notable shift in the right direction but achieving what appears to be simple targets is a highly complex endeavour across both wealthy and less wealthy countries and jurisdictions. Improving health for all targets requires political-economic, bureaucratic and alignment with bottom-up grass-roots agencies. Despite present successes, there is a need to adapt to constant challenges including pandemics, adverse climate phenomena and political-economic shifts.

RATIONALE, AIMS, AND OBJECTIVES: This study aims to investigate how reported comprehension of the Medicare program and its prescription drug benefits affects cost-related medication nonadherence (CRN) among Medicare beneficiaries with cardiovascular disease (CVD) risk factors. METHODS: This cross-sectional study used the 2017 Medicare Current Beneficiary Survey Public Use File data and included Medicare beneficiaries aged ≥ 65 years who reported having at least one CVD risk factor (i.e., hypertension, hyperlipidemia, diabetes, smoking, and obesity) (n=2,821). A survey-weighted logistic model was used to examine associations between lack of difficulty understanding the Medicare program and its prescription drug benefits and CRN, controlling for beneficiaries’ demographic (e.g., age) and clinical characteristics (e.g, comorbidities). This study further analyzed five subgroups based on the type of CVD risk factors involved. RESULTS: Among Medicare beneficiaries with CVD risk factors, 14.4% reported CRN. Medicare beneficiaries with CVD risk factors who reported difficulty understanding the overall Medicare program and its prescription drug benefits were more likely to report CRN, compared to those who reported easy understanding of the overall Medicare program (OR=1.49; 95% CI=1.09, 2.04; p<0.001) and its prescription drug benefits (OR=2.01; 95% CI=1.51, 2.67; p<0.001). Similar results were obtained for the subgroups with obesity, hypertension, or hyperlipidemia. CONCLUSIONS: Perceived lack of difficulty understanding the Medicare Program and its prescription drug benefits has a positive impact on CRN reduction among Medicare beneficiaries with CVD risk factors, especially those with obesity, hypertension or hyperlipidemia. Monitoring and enhancing Medicare beneficiaries’ overall understanding of the Medicare program may reduce CRN.

The aim of the present paper is to describe and discuss how recent theories about translation, bridging medical and humanistic understandings of knowledge translation, in the medical humanities (Kristeva et al 2018) can bring about a new understanding of health literacy in the context of patient education. We argue that knowledge translation must be understood as a simultaneous interrogation of the patient’s and the health care providers co-construction of new and shared meanings that can create realities with medical consequences. To illustrate our points, we will describe the case of Jim, a kidney transplant recipient who received standard patient education, but lost the graft (the new kidney). If we apply Kristeva’s view onto this context, graft function is not merely a biology but a complex bio-cultural fact. In this perspective, graft function is seen as a phenomenon that embraces translation between health as a biomedical phenomenon and healing as lived experience, and that opens for shared meaning -making processes between the patient and the health care provider. In Jim’s case this means that we need to rethink the approach to patient education in a way that encourage the patient’s idiosyncratic way of thinking and experiencing – and transform health information into a means for sustaining Jim’s particular life – not life ‘in general’. The patient education program did not take into consideration the singularities of Jim’s biographical temporality, with its changes in everyday life, priorities, attitudes and values. The arguments are generic and could be applied to other contexts.

The frantic search for a cure or prophylactic treatment of COVID-19 has unfortunately led to a dropping of the guard of many medical specialists resulting in widespread adoption of unproven treatment modalities. The recent article regarding the inconsistent physician attitudes towards hydroxychloroquine paints a depressing picture of the actual practices during the so-called era of evidence-based medicine. On this backdrop, we comment on how Romania (where this survey took place) has imposed some of the most severe lockdown measures in Europe, including the forced hospitalization of all confirmed with SARS-CoV-2 infection. Additionally, a therapeutic guideline was written into law, endorsing concomitant use of several drugs with unproven antiviral efficiency. This unprecedented situation has resulted in the sometimes indiscriminate prescription of off-label drugs, with a non-negligible risk of adverse reactions, especially in fragile patients with coexisting conditions. In light of the experience accrued in a COVID-19 dedicated unit, the authors discuss the importance of avoiding polypharmacy and administering all antiviral drugs within the confines of rigorously conducted clinical trials.

Rationale, aims and objectives New therapies are increasingly approved by regulatory agencies such as the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) based on testing in non-randomized clinical trials. These treatments have typically displayed “dramatic effects” (i.e., effects that are considered large enough to obviate the combined effects of bias and random error). The agencies, however, have not identified how large these effects should be to avoid the need for further testing in randomized controlled trials (RCTs). We investigated the effect size that would circumvent the need for further RCTs testing by the regulatory agencies. We hypothesized that the approval of therapeutic interventions by regulators is based on heuristic decision-making whose accuracy can be best characterized by the application of signal detection theory (SDT). Methods We merged the EMA and FDA database of approvals based on non-RCT comparisons. We excluded duplicate entries between the two databases. We included a total of 134 approvals of drugs and devices based on non-RCTs. We integrated Weber-Fechner law of psychophysics and recognition heuristics within SDT to provide descriptive explanations of the decisions made by the FDA and EMA to approve new treatments based on non-randomized studies without requiring further testing in RCTs. Results Our findings suggest that when the difference between novel treatments and the historical control is at least one logarithm (base 10) of magnitude, the veracity of testing in non-RCTs seems to be established. Conclusion Drug developers and practitioners alike can use the change in one logarithm of effect size as a benchmark to decide if further testing in RCTs should be pursued, or as a guide to interpreting the results reported in non-randomized studies. However, further research would be useful to better characterize the threshold of effect size above which testing in RCTs is not needed.

Aims: The aim of this study was to investigate in detail the traumatic birth experiences of midwives in the delivery rooms, and their attitudes, reactions, and coping strategies. Methods: The design of the study is descriptive and the purposive sampling method was used. This approach is ideal for a preliminary exploration of the nature of a phenomenon. Between October 2018 and January 2019, semi-structured interviews were conducted with a purposeful sample of midwives. The research was carried out with the participation of 29 midwives, who work in labour and birth room. They were asked to describe a particular stressful situation they had experienced during the birth process, their emotions about the event, and their coping strategies and support systems. All interviews were digitally recorded, stored in a database, and transferred to MAX Qualitative Data Analysis 18.1.0 for analysis. Results: As a result of the content analysis, three main themes emerged: Psychological impact, defensive practice, and expectations from the hospital. It was revealed that, after the traumatic birth, midwives experienced highly emotional exhaustion in the form of sadness, flashbacks, guilt, fear, and empathy, and that they performed an increasingly defensive practice. Besides, midwives explicitly stated that they were not prepared enough for traumatic events and that most traumatic births were simply ignored in their workplace. Eventually, it was determined that midwives received support mostly from their colleagues in case of a traumatic birth. Conclusion(s): Midwives need to feel valued and be supported by their institutions in coping with emotional stress. Therefore, performing clinical inspections by experienced or specialist midwives may serve as a supporting framework for reducing defensive interventions.

Rationale, aims and objectives In the US, the reluctance of the federal government to impose a national stay-at-home policy in wake of COVID19 pandemic has left the decision of how to achieve social distancing to individual state governors. We hypothesized that in the absence of formal guidelines, the decision to close a state reflects the classic Weber-Fechner law of psychophysics- the amount by which a stimulus (such as number of cases or deaths) must increase in order to be noticed as a fraction of the intensity of that stimulus. Methods On April 12, 2020 we downloaded data from the New York Times database from all 50 states and the District of Columbia; by that time all but 7 states had issued the stay-at-home orders. We fitted the Weber-Fechner logarithmic function by regressing the log2 of cases and deaths respectively against the daily counts. We also conducted Cox regression analysis to determine if the probability of issuing the stay-at-home order increases proportionally as the number of cases or deaths increases. Results We found that the decision to issue the state-at-home order reflects the Weber-Fechner law. Both the number of infections (p=<0.0001; R2=0.79) and deaths (p<0.0001; R2=0.63) were significantly associated with the decision to issue the stay-at-home orders. The results indicate that for each doubling of infections or deaths, an additional 4 to 6 states will issue stay-at-home orders. Cox regression showed that when the number of deaths reached 256 and the number of infected people were over 16,000 the probability of issuing “stay-at-home” order was close to 100%. We found no difference in decision-making according to the political affiliation; the results remain unchanged on July 16,2020. Conclusions when there are not clearly articulated rules to follow, decision-makers resort to simple heuristics, in this case one consistent with the Weber-Fechner law.

Rationale, aims and objectives: The available evidence on the existence and consequences of the use of heuristics in the clinical decision process is very scarce. The purpose of this study is to measure the use of the Representativeness, Availability and Overconfidence heuristics in real conditions with Primary Care physicians in cases of dyspnea and to study the possible correlation with diagnostic error. Methods: A prospective cohort study was carried out in 4 Primary Care centers in which 371 new cases or dyspnea were registered. The use of the three heuristics in the diagnostic process is measured through an operational definition of the same. Subsequently, the statistical correlation with the identified clinical errors is analyzed. Results: In 9.97% of the registered cases a diagnostic error was identified. In 49.59% of the cases, the physicians used the representativeness heuristic in the diagnostic decision process. The availability heuristic was used by 82.38% of the doctors and finally, in more than 50% of the cases the doctors showed excess confidence. None of the heuristics showed a statistically significant correlation with diagnostic error. Conclusion: The three heuristics have been used as mental shortcuts by Primary Care physicians in the clinical decision process in cases of dyspnea, but their influence on the diagnostic error is not significant. New studies based on the proposed methodology will allow confirming both its importance and its association with diagnostic error.

Both in medicine and in psychiatry, it’s essential to thoroughly identify the cases in which it is necessary to intervene therapeutically, and justify a sick leave or make forensic interpretations, among others. Therefore, it is important to find a general concept and definition for medical and psychiatric disorders. Boorse, develops one of the most widespread models of medical disorder that aspired to be value-free and that was based in medical dysfunction. But values appear implicitly or explicitly with a deeper analysis of this concept. On the other hand, there is the overtly value laden (harm) component that has been used in the definition of disorder, defended as essential by several authors over the time, once symptoms and their consequences (disability, distress) have been considered as a priority in medicine. In this article, we intend to review, through a conceptual analysis, the proximity between the concepts of mental and physical disorders regarding the presence of values, and to propose a way to deal with the different kinds of values that might be present. It is concluded that values are present in the main concepts that have been used to define medical or psychiatric disorder. What is essential is to understand what is descriptive and what is value and to try to avoid moral values.

Rationale Assessing the performance of diagnostic tests requires evaluation of the amount of diagnostic uncertainty the test reduces (i.e. 0% - useless test, 100% - perfect test). Statistical measures currently dominating the evidence-based medicine (EBM) field and particularly meta-analysis (e.g. sensitivity and specificity), cannot explicitly measure this uncertainty reduction. Mutual information (MI), an information theory statistic, is a more appropriate metric for evaluating diagnostic tests as it explicitly quantifies uncertainty and, therefore, facilitates natural interpretation of a test’s value. In this paper, we propose the use of MI as a single measure to express diagnostic test performance and demonstrate how it can be used in meta-analysis of diagnostic test studies. Methods We use two cases from the literature to demonstrate the applicability of MI meta-analysis in assessing diagnostic performance. These cases are: 1) Meta-analysis of studies evaluating ultrasonography (US) to detect endometrial cancer and 2) meta-analysis of studies evaluating magnetic resonance angiography to detect arterial stenosis. Results Results produced by the MI meta-analyses are comparable to the results of meta-analyses based on traditionally used statistical measures. However, the results of MI are easier to understand as it relates directly to the extent of uncertainty a diagnostic test can reduce. For example, a US test diagnosing endometrial cancer is 40% specific and 94% sensitive. The combination of these values is difficult to interpret and may lead to inappropriate assessment (e.g. one could favour the test due to its high sensitivity, ignoring its low specificity). In terms of MI however, the test reduces diagnostic uncertainty by 10%, which is marginal and thus the test is clearly not very useful. Conclusions We have demonstrated the suitability of MI in assessing the performance of diagnostic tests, which can facilitate easier interpretation of the true utility of diagnostic tests.

Rationale, Aims and Objectives: Alignment between patients’ treatment choices and treatments received is acknowledged as an important outcome of shared decision-making (SDM), yet recent research suggests that patients’ choices do not always align with their actual treatment trajectories. This paper explores the alignment of patient-expressed treatment choices (for surgery or medical management) after exposure to decision aids and treatments received among patients with hip or knee osteoarthritis within High Value Healthcare Collaborative (HVHC) systems as the collaborative integrating decision aids intended to support SDM into routine clinical practice. Method: This retrospective cohort study examines data from adult (>18 years) patients with hip or knee osteoarthritis who received decision aids as part of orthopedic consultations within HVHC systems between 2012-2015. Multivariate logistic regression explored the association between patient-level characteristics with the odds of treatment choice-receipt alignment. Results: The majority of patients with knee osteoarthritis (68.3%) and hip osteoarthritis (71.9%) received treatments aligned with their choices following exposure to decision aids, but analyses reveal important differences in the odds of such alignment across patient characteristics. In adjusted models, African American patients with knee osteoarthritis had 50% lower odds of receiving treatment aligned with their choices compared with white patients (OR = 0.52, p<0.05). Medicare- or Medicaid-insured knee patients had 49% and 59% lower odds (respectively) of receiving choice-aligned treatments relative to privately insured patients. Patients with knee (OR = 0.40, p<0.01) or hip (OR = 0.75, p<0.05) osteoarthritis at earlier decision-making stages had lower odds of receiving treatments congruent with their choices. Conclusion: This work elucidates the odds of treatment choice-aligned care for patients within health care systems attempting to routinely integrate decision aids to support SDM into clinical practice and underscores the gaps in achieving this alignment among African American patients, those with public insurance and those at early decision-making stages.

Rationale Prescribed opioids are major contributors to the current international public health opioid crisis. Such iatrogenic calamities usually result from collective decision failures of healthcare organizations rather than solely of individual organizations or professionals. Findings from a system-wide safety analysis of the iatrogenic opioid crisis that includes roles of pertinent healthcare organizations may help avoid or mitigate similar future tragedies. In this exploratory study, we report on such an analysis. Methods Root cause analysis, incorporating recent suggestions for improvement, was used to retrospectively identify possible causal factors from the literature. Based on their mandated roles and potential influences to prevent or mitigate the iatrogenic crisis, relevant organizations were grouped and stratified from most to least influential. Results The analysis identified a chain of multiple interrelated causal factors within and between organizations. The most influential organizations were: pharmaceutical, political and drug regulatory; next: experts and their related societies, and publications. Less influential: accreditation, professional licensing and regulatory, academic and healthcare funding bodies. Collectively, their views and decisions influenced prescribing practices of frontline healthcare professionals and advocacy groups. Financial associations between pharmaceutical and all other organizations/groups were common. Ultimately, patients were adversely affected. There was a complex association with psychosocial variables. Limitations Our analysis suggests associations not causality. Conclusions The iatrogenic crisis has multiple intricately linked interacting roots. The major catalyst: pervasive pharma-linked financial conflicts of interest (CoIs) involving most of the other healthcare organizations. These extensive financial CoIs were likely triggers for a cascade of erroneous decisions and actions that adversely affected patients. The actions and decisions of pharma ranged from unethical to illegal. The iatrogenic opioid crisis exemplifies widespread “institutional corruption of pharmaceuticals.”

Purpose This paper aims to elucidate the factors that play into physicians’ experience of receiving practice data and to subsequently develop a model that describes how individuals may interact with the data they receive. Methods In a prior study, we conducted a needs analysis of 105 physicians in the Hamilton-Niagara area in order to understand which data metrics were most valuable to physicians. Using these results, we designed an interview guide to study physicians’ perspectives on audit and feedback. By intentional sampling, we recruited 15 physicians amongst gender groups, types of practice (academic vs community), and duration of practice. The interviews were conducted by a single author and transcribed without identifiers. We then began with an open coding analysis for all of the transcripts, and thereafter conducted axial coding to group the data into larger themes. Results Several environmental and personal attributes were identified as either enabling or counterproductive attributes for participant improvement. The final proposed model identifies different zones of engagement on the basis of both the individual practitioner’s growth mindset and the quality of the existing data system. In the highest engagement zone, the mindset of the collective leadership is one of growth. Systemic supports are in place which potentiates learning that may come from an individual motivated to use their own data. Conclusion Our model shows how data feedback systems and individual growth-oriented mindsets interact to augment or hinder clinical practice improvement. This model provides important guidance to academic and administrative structures looking to develop appropriate performance feedback systems with clinicians.