Abstract Rationale: Our current global healthcare system is not sustainable. It is structured based on the principles of reductionist science which was discovered and developed over the past 400 – 600 years. Because of increasing pace of change and increasing complexity in our world we have increased fragmentation in our healthcare system leading to more harm and waste. Over 100 years ago, the principles of systems, or complexity, science were discovered, first in the discipline of physics. These principles accommodate the constant change and biologic variability in our world. While reductionist principles would be applicable in a static, mechanical world where parts of the system could be isolated, this does not exist in the real biologic world. Method: For the past decade, our abdominal wall hernia team has been applying the principles of systems science to real patient care. Some of the tools we have applied include continuous quality improvement for whole hernia patient processes and non-linear analytical tools to gain insight to improve value-based outcomes. Until we learn to apply and scale these principles across our whole global healthcare system, we will continue to suffer the consequences of our current unsustainable system. Results: We have learned that the application of systems and complexity science to real patient care can lead to lower costs and better outcomes in the context of patients with complex hernia problems. However, these concepts have not yet been adopted in our global healthcare system. Conclusion: Applying the principles of systems and complexity science to our global healthcare system has the potential to lower costs and improve patient outcomes for any patient care process to which it is applied.

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: The diversity of safety signals (e.g., case reports, animal studies and observational studies) makes the assessment of the (un-)safety of a drug a formidable challenge. While frequentist viewpoints to uncertain inference struggle in aggregating these signals, the more flexible Bayesian approaches seem better suited for this quest. Artificial Intelligence (AI) offers great promise to these approaches for information retrieval, decision support and leaning probabilities from data. E-Synthesis is a Bayesian framework for drug safety assessments build on philosophical principles and considerations. It aims to aggregate all the available information, in order to provide a Bayesian probability of a drug causing an adverse reaction. We delineate and assess ways in which AI can support E-Synthesis. Results: We find that AI can help with information retrieval, usability (graphical decision making aids), learning Bayes factors from historical data, assessing quality of information and determining conditional probabilities for the so-called “indicators” of causation for E-Synthesis. Conclusions: Properly applied, AI can help the transition of philosophical principles and considerations concerning evidence aggregation for drug safety to a tool that can be used in practise.

Background: The COVID-19 pandemic represents one of the most stressful events of recent times. Among the population, healthcare professionals who treat COVID-19 patients are most likely to develop psychological distress and posttraumatic stress symptoms (PTSS). The present study thus aimed to investigate the psychological impact of the COVID-19 outbreak on Italian healthcare workers. Methods: The responses of 145 healthcare workers (72 medical doctors and 73 nurses) were included in the final dataset. Participants were asked to provide sociodemographic and clinical information, and to complete: 1) quality of life and health-related Visual Analogue Scales, 2) State-Trait Anxiety Inventory-Form Y1, 3) Beck Depression Inventory, and 4) PTSD Checklist for DSM-5. Results: A comparison between healthcare professionals working in COVID-19 wards and other units revealed that the former reported higher levels of both depressive symptoms and PTSS. Moreover, the results of regression analyses showed that in healthcare professionals working with COVID-19 patients, gender and marital status, and gender and age significantly predicted depressive symptoms and PTSS, respectively. Particularly, being female and not in a relationship were found to be associated with higher levels of depressive symptoms, whereas being female and older were found to be related to higher levels of PTSS. Conclusions: The current findings suggest that specific predisposing factors could identify healthcare workers who are at high risk of developing mental health symptoms when faced with COVID-19 patients.

This paper responds to one by Graham Martin and colleagues, who offered a critique of my previous publications on masks for the lay public in the Covid-19 pandemic. I address their charges that my co-authors and I had misapplied the precautionary principle; drawn conclusions that were not supported by empirical research; and failed to take account of potential harms. But before that, I remind Martin et al that the evidence on mask wearing goes beyond the contested trials and observational studies they place centre stage. I set out some key findings from basic science, epidemiology, mathematical modelling, case studies and natural experiments, and use this rich and diverse body of evidence as the backdrop for my rebuttal of their narrowly-framed objections. I challenge my critics’ apparent assumption that a particular kind of systematic review should be valorised over narrative and real-world evidence, since stories are crucial to both our scientific understanding and our moral imagination. I conclude by thanking my academic adversaries for the intellectual sparring match, but exhort them to remember our professional accountability to a society in crisis. It is time to lay straw men to rest and engage, scientifically and morally, with the dreadful tragedy that is unfolding across the world.

Inappropriate use of telemetry frequently occurs in the inpatient, non-intensive care unit setting. Recent telemetry practice standards have attempted to guide appropriate use and limit the overuse of this important resource, with limited success. Clinical-effectiveness studies of these practice standards have thus far not included care settings in which resident-physicians are the primary caregivers. Furthermore, studies of the role of nurses in appropriate telemetry use are lacking. In this report, we describe two interventions implemented on general internal medicine units of a large academic hospital over three years. The first intervention, or nurse-discontinuation protocol, allowed nurses to trigger the discontinuation of telemetry once the appropriate duration had passed according to practice standards. The second intervention, or physician-discontinuation protocol, instituted a Best Practice Advisory that notified the resident-physician via the electronic medical record when the appropriate telemetry duration for each patient had elapsed and suggested termination of telemetry. Results showed that the nurse-discontinuation protocol reduced mean patient time on telemetry and the physician-discontinuation protocol reduced mean telemetry orders per patient. These findings validate a prior study and expand on our understanding of telemetry use in the academic care setting in which trainees serve as the primary caregivers.

Rationale, Aims and Objectives: Guidelines recommend inviting family members of intensive care unit (ICU) patients to rounds. We aimed to create a toolkit to support family participation in ICU bedside rounds, based upon evidence from research and in collaboration with ICU family member representatives and healthcare providers. Methods: A multi-method qualitative research program was conducted to provide an evidence-base. Ethnographic observations of rounds and interviews and focus groups with family members and ICU healthcare providers were analyzed for key themes, barriers and facilitators of participation, and suggestions. A full day workshop with family representatives and providers (physicians, nurses, social workers, and unit managers) from a diverse range of adult ICUs in Western Canada, including several community ICUs and a majority of large, urban ICUs enabled the collaborative development of key toolkit elements. Results: We have developed an evidence-informed approach to patient-and-family-centered rounds that highlights the importance of 6 key elements foundational to patient and family centered rounds: Invitation, Orientation, Engagement, Summary, Questions, and Communication Follow-Up. We describe strategies, techniques, and templates to optimize these elements and interactions so that communication is more meaningful, and to facilitate the ability of family members to adopt a meaningful role as contributing members of the care team. Conclusion: There is consensus on general strategies for facilitating family participation in rounds and meaningful communication between family and the healthcare team during rounds as an important element of the continuum of communication in the ICU. The incorporation of these elements should be standardized, though tailored to user needs.

One knowledge translation method, of putting evidence into practice, is the use of clinical practice guidelines (CPG). The purpose of this brief report is to describe an 8-step process of “how to” contextualise a training programme to increase CPG-uptake for a targeted audience in a clearly defined setting. This process may assist implementalists to fast-track the development of contextualised training to improve CPG-uptake.

Decision-making in musculoskeletal health care is complex, with discrepancy among clinical providers, and variation in the per cent of referrals for specialist care. To date there is an increased focus on specialist referrals, risking overuse of expensive testing and contributing to unnecessary treatment. This report will considerer the difficulties of primary care musculoskeletal decision-making using shoulder injuries as an example, presenting a solution based on multi-criteria decision-making analysis with online software. The associated issues involved in clinical decision-making are complex. Contributing to the components of complexity are; the aetiology of shoulders being multi-faceted, the experience and knowledge of providers, and the burden of patient demands. Notwithstanding, funding considerations, resource allocation availability, and other associated issues around clinical decision-making. Considering there are many facets involved in decision-making, this is an area where multi-criteria decision-making analysis (MCDM) may be appropriate. MCDM which uses mathematical analysis, is increasingly being used in health care and could be applied to the challenges of musculoskeletal care. MCDM has the potential to decrease variability in decision-making and be used as a tool to augment clinical decisions. Furthermore, the key clinical factors that decision-making is based on are to date unclear, therefore, this preliminary report offers a start towards moving to a clarification of the key factors, and an approach for implementing improved shoulder clinical care decision-making which could then be adapted and applied to other body sites.

Since news of COVID-19 outbreak hit the mainstream media, I have received several calls from acquaintances about if and how they should be worried. I suspect many readers of the Journal of Evaluation in Clinical Practice have experienced the same. What makes communicating the risk difficult can be illustrated through a recent assignment I gave to my undergraduate class focused on how we use science in public policy. I asked the students to identify claims in the media regarding the virus and then search the literature to assess the level of support for such claims. Suffice it to say, they found several claims unsupported, and several others to be inconclusive. Not very good grounding for providing definitive (or even satisfying) advice.

Objective: High data quality is essential to ensure the validity of clinical and research inferences based on it. However, these data quality assessments are often missing even though these data are used in daily practice and research. Our objective was to evaluate the data quality of our high-resolution electronic database (HRDB) implemented in our pediatric intensive care unit (PICU). Design: A prospective validation study of a HRDB. Setting: A 32-bed pediatric medical, surgical and cardiac PICU in a tertiary care freestanding maternal-child health center in Canada. Population: All patients admitted to the PICU with at least one vital sign monitored using a cardiorespiratory monitor connected to the central monitoring station. Interventions: None Measurements and Main Results: Between June 2017 and August 2018, data from 295 patient days were recorded from medical devices and 4,645 data points were video recorded and compared to the corresponding data collected in the HRDB. Statistical analysis showed an excellent overall correlation (R2=1), accuracy (100%), agreement (bias=0, limits of agreement=0), completeness (2% missing data) and reliability (ICC=1) between recorded and collected data within clinically significant pre-defined limits of agreement. Divergent points could all be explained. Conclusions: This prospective validation of a representative sample showed an excellent overall data quality.

Rationale aims and objectives Potentially preventable hospitalizations (PPH) are a challenge. What happens before hospital admission? Are there crucial tipping points before admissions in at-risk cohorts’ trajectories? HealthLinksChronicCare (HLCC) hospital risk-prediction algorithms using admission, diagnosis, and lifestyle data identifies at-patients. MW monitors HLCC patients with outbound phone calls using telehealth – the Patient Journey Record System with alerts representing a real-time anticipated risk of PPH. Health Coaches triage and intervene to optimize GP, hospital and community service utilization to reduce the risk of PPH. Aims To describe a time series of telehealth phone calls related to an acute admission ( 10 days) to investigate tipping points in self-reported biopsychosocial environmental concerns (total alerts) and or condition symptoms of concern (red alerts). Methods MW participants had an acute (non-surgical) admission and >44 calls between 23/12/16 - 11/10/17. The Patient Journey Record System (PaJR) and Victorian Admitted Episode Data/ Emergency Minimum Dataset provided longitudinal data. Descriptive time series analysis employed Pettitt’s homogeneity test to detect ‘tipping points’ using XLSTAT package. Findings One hundred three patients aged 74 ± 15.4 years, with 59% male and 61% female, provided 764 call records around admission(s) and 22,715 records over 10 months. Total alerts and red alerts were higher in the 10 days before and after admission. Total alerts significantly increased (tipped) at day 3 before hospitalisation persisting until 10 days. Red alerts increased (tipped) 1 day before admission and remained high following discharge. Discussion and Conclusion Self-report in phone calls describe a pre-hospital phase of ‘post-hospital syndrome’ (PHS), which began at least 10 days before admission and persisted after discharge. Wide-ranging health, psychosocial, and environmental concerns preceded a tipping point into acute symptoms. Telehealth monitoring of biopsychosocial, as well as disease, concerns require further investigation.

Rationale: Conventional models of cultural humility - even those extending analysis beyond the dyad of healthcare provider-patient to include concentric social influences such as families, communities and institutions that make the clinical relationship possible - aren’t conceptually or methodologically calibrated to accommodate shifts occurring in contemporary biomedical cultures. More complex models are required that are attuned to how advances in biomedical, communications and information technologies are increasingly transforming the very cultural and material conditions of health care and its delivery structures, and thus how power manifests in clinical encounters. Methodological Intervention: In this paper, we offer a two-pronged intervention in the cultural humility literature. At a first level of analysis, we suggest the need to broaden understandings of culture and associated workings of power to accommodate the effects of biomedicine’s technologising turn. A second level of intervention invites experimentation to broaden the availability of methodological tools to analyse and assess the multidimensionality of technologies and their agentic effects in healthcare encounters. Drawing from new materialism theories, practices of care are approached “diffractively” as contingent and dynamic material-discursive events. Our neo-materialist framework for cultural humility expands analytical sight-lines beyond hierarchical relationships and dichotomies privileging humans (practitioner and/or patient) as sole actants in the clinical exchange. Attended to are the ongoing dynamics of practices entangling big-data driven knowledges and interventions, pharmacological technologies and material instruments and devices, diseases, and the bodies/subjectivities of health care providers and patients. We investigate the implications for clinical assessment if a cultural humility framework is methodologically attuned to the clinical encounter as a discontinuous, discursive-material process producing multiple, contextually emergent data moments and objects for analysis. Engaging evaluative inquiry diffractively allows for a different ethical practice of care, one that attends to the forms of patient and health provider accountability and responsibility emerging in the clinical encounter.

Rational, aims and objectives: This study aimed to assess knowledge, attitude and practice (KAP) of using insulin pen in diabetes and determine the related factors to the KAP, adverse drug reactions (ADRs) and glycemic control status. Methods: In our descriptive study, 148 patients with diabetes were interviewed by 16-item questions on knowledge and 8 questions on attitude, and were asked to present the insulin pen injection technique with a sample insulin pen. Results: Proportions of patient having a good knowledge, positive attitude, and good practice were 45.9%, 78.4%, and 44.6%, respectively. The three most incorrect steps were skipping to prime pen needle (90.9%), not removing the used needle from the pen after using (87.8), and not holding for specific count time before withdrawal of pen needle from skin (50.7%). Patients having duration of insulin one year or more had better knowledge (p=0.025), more positive attitude (p=0.017), and better practice of insulin (p=0.042). Patients using insulin combined with oral diabetic medications or having history of using insulin vials had more positive attitude of insulin role (0.038). Frequency of having good knowledge was statistically significantly higher in participants who received counseling from health professionals previously (p=0.001). The study also found a positive correlation between good knowledge of patients and good practical skills (p<0.001). Patients with poor practice of insulin were more likely to have ADRs at the injection sites (p = 0.013). The worse knowledge of patients was significant related to the higher risk of hypoglycemia (p=0.001). KAP levels did not correlate with glycemic control status. Conclusions: Positive attitude in patients was recorded at a significant rate; however, knowledge and practice needs improvement. This study was helpful to shape the patient education and target specific patients for education.

Rationale and objectives: Changes in, and predictors of, quality of life (QoL) among unstable angina patients are informative for both clinical and public health practice. However, there is little research on this topic, especially in healthcare settings with limited resources. This study aims to detect changes in QoL and its associated factors among patients with unstable angina after percutaneous coronary intervention. Methods: A quasi-experimental design was conducted with two repeated rounds of measurements, one month and three months after intervention, using the generic SF-36 questionnaire, in 120 patients from Vietnam National Heart Institute. A linear mixed-effects model was used to assess changes in patient QoL over time while adjusting for other covariates. Results: Only 2 out of 8 QoL subscales (social functioning and emotional well-being) declined after one month, but these tended to rise again after three months, while scores of all other QoL subscales increased. Adjusting for covariates, QoL increased slightly after one month of intervention (β=0.65, 95%CI=-0.86-2.16) but improved by almost 6 QoL points after 3 months (β=5.99, 95%CI=4.48-7.50). Four confounders significantly associated with a decline in QoL were older age, being retired, living in rural areas, and having abnormal troponin level. Conclusion: QoL of the patients with unstable angina improves significantly three months after intervention, rather than after one month. To increase QoL, it is important to address risk factors and to improve the quality of healthcare delivery.

Background and Objective Clinical Practice Guidelines (CPGs) provide evidence-based recommendations to healthcare professionals, policy makers, patients and other stakeholders. Mexico is the biggest producer of CPGs in Latin America and Caribbean countries. The National Healthcare Technology Excellence Center (acronym in Spanish: CENETEC) is responsible for the CPG development, adaptation and update. The aim of this study was to assess the Mexican CPG quality and adherence to the GRADE framework. Study design We conducted a descriptive cross-sectional study of 86 CPGs representing all the CPGs produced by CENETEC between 2015 and 2017 and published in an online database called “Catalogo Maestro”. We performed quality assessment with the online AGREE II tool and assessed the reporting on the GRADE framework. Results Of the 86 CPGs, 34 were published in 2015, 21 in 2016 and 31 in 2017. The overall quality by AGREE II proved a median of 16.6% (Min 16.6%, Max 50%). Of the 86 CPGs, 25 (29%) used the GRADE framework; adherence to GRADE standards was, however, inconsistent and generally poor. Conclusion CPGs produced by CENETEC during this period had a low score by AGREE II standards and low adherence to the GRADE framework. A concerted initiative could rapidly improve CENETEC guidelines.

Background: Lack of time has consistently been reported as a major barrier to effective research evidence-uptake into clinical practice. There has been no research to our knowledge that explores time as a barrier within the Transtheoretical model of Stages of Change (SoC), to better understand the processes of physiotherapists’ uptake of clinical practice guidelines (CPG). This paper explores the concept of lack of time as a barrier for CPG uptake for physiotherapists at different SoC. Methods: A 6-step process is presented to determine the best-fit SoC for 31 physiotherapy interviewees. This process used an amalgamation of interview findings and socio-demographic data, which was layered onto the SoC and previously identified time-barriers to CPG uptake (few staff; high workload; access to CPGs; evidence-based practice as priority in clinical practice; “time is money” attitude; and knowledge on the use of CPGs). Results: The analysis process highlighted the complexities of assigning individuals to a SoC. A model of time management for better CPG uptake is proposed which is a novel approach to assist evidence implementalists and clinicians alike to determine how to progress through the SoC and barriers to improve CPG uptake. Conclusions: To the authors’ knowledge, this is the first attempt at exploring the construct of (lack of) time for CPG-uptake in relation to the physiotherapists’ readiness to behaviour change. This study shows that ‘lack of time’ is a euphemism for quite different barriers, which map to different stages of readiness to embrace current best evidence into physiotherapy practice. By understanding what is meant by ‘lack of time’, it may indicate specific support required by physiotherapists at different stages of changing these behaviours.

Background: Most studies on the transition from pediatric to adult care focus on practices at a single institution. We examine the transition for young adults with type 1 diabetes across an entire Canadian province with a small, mostly rural population: Newfoundland and Labrador (NL). Our aim is to determine a comprehensive picture of how transition is occurring in one jurisdiction and explore potential methods for improvement. Methods: A provincial diabetes database and hospital admission data were reviewed for a cohort of young adults who transitioned into adult care to determine the number of transfers occurring, patient characteristics, and the number of diabetes-related hospitalizations. Semi-structured interviews with pediatric and adult diabetes providers were conducted to determine the current process of transition and identify ways for improvement, including the potential role of family physicians. Results: Between 2008 and 2013, 93 patients with type 1 diabetes transitioned into adult care. Fifteen interviews were conducted across the province’s four regional health authorities. Various models of transition care are being employed, reflecting staff and resource availability. While no structured transition program was identified, many providers were comfortable with their current transition processes. Suggested improvements included more structured processes, shared educational resources, and a dedicated transfer clinic. Conclusions: In a province with a relatively small number of patients who transition out of pediatric care annually, we found different approaches for transitioning them into adult care, but this variation may not negatively impact patient outcomes.