What can Safety Cases offer for patient safety? A multisite case study

Background The Safety Case is a regulatory technique that requires organisations to demonstrate to regulators that they have systematically identified hazards in their systems and reduced risks to being as low as reasonably practicable. It is used in several high-risk sectors, but only in a very limited way in healthcare. We examined the first documented attempt to apply the Safety Case methodology to clinical pathways. Methods Data are drawn from a mixed-methods evaluation of the Safer Clinical Systems programme. The development of a Safety Case for a defined clinical pathway was a centrepiece of the programme. We base our analysis on 143 interviews covering all aspects of the programme and on analysis of 13 Safety Cases produced by clinical teams. Results The principles behind a proactive, systematic approach to identifying and controlling risk that could be curated in a single document were broadly welcomed by participants, but was not straightforward to deliver. Compiling Safety Cases helped teams to identify safety hazards in clinical pathways, some of which had been previously occluded. However, the work of compiling Safety Cases was demanding of scarce skill and resource. Not all problems identified through proactive methods were tractable to the efforts of front-line staff. Some persistent hazards, originating from institutional and organisational vulnerabilities, appeared also to be out of the scope of control of even the board level of organisations. A particular dilemma for organisational senior leadership was whether to prioritise fixing the risks proactively identified in Safety Cases over other pressing issues, including those that had already resulted in harm. Conclusions The Safety Case approach was recognised by those involved in the Safer Clinical Systems programme as having potential value. However, it is also fraught with challenge, highlighting the limitations of efforts to transfer safety management practices to healthcare from other sectors

Implementing an evidence-based computerized decision support system linked to electronic health records to improve care for cancer patients: the ONCO-CODES study protocol for a randomized controlled trial.

BACKGROUND: Computerized decision support systems (CDSSs) are computer programs that provide doctors with person-specific, actionable recommendations, or management options that are intelligently filtered or presented at appropriate times to enhance health care. CDSSs might be integrated with patient electronic health records (EHRs) and evidence-based knowledge. METHODS/DESIGN: The Computerized DEcision Support in ONCOlogy (ONCO-CODES) trial is a pragmatic, parallel group, randomized controlled study with 1:1 allocation ratio. The trial is designed to evaluate the effectiveness on clinical practice and quality of care of a multi-specialty collection of patient-specific reminders generated by a CDSS in the IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) hospital. We hypothesize that the intervention can increase clinician adherence to guidelines and, eventually, improve the quality of care offered to cancer patients. The primary outcome is the rate at which the issues reported by the reminders are resolved, aggregating specialty and primary care reminders. We will include all the patients admitted to hospital services. All analyses will follow the intention-to-treat principle. DISCUSSION: The results of our study will contribute to the current understanding of the effectiveness of CDSSs in cancer hospitals, thereby informing healthcare policy about the potential role of CDSS use. Furthermore, the study will inform whether CDSS may facilitate the integration of primary care in cancer settings, known to be usually limited. The increasing use of and familiarity with advanced technology among new generations of physicians may support integrated approaches to be tested in pragmatic studies determining the optimal interface between primary and oncology care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02645357

Seven features of safety in maternity units: a framework based on multisite ethnography and stakeholder consultation

Background: Reducing avoidable harm in maternity services is a priority globally. As well as learning from mistakes, it is important to produce rigorous descriptions of ‘what good looks like’. Objective: We aimed to characterise features of safety in maternity units and to generate a plain language framework that could be used to guide learning and improvement. Methods: We conducted a multisite ethnography involving 401 hours of non-participant observations 33 semistructured interviews with staff across six maternity units, and a stakeholder consultation involving 65 semistructured telephone interviews and one focus group. Results: We identified seven features of safety in maternity units and summarised them into a framework, named For Us (For Unit Safety). The features include: (1) commitment to safety and improvement at all levels, with everyone involved; (2) technical competence, supported by formal training and informal learning; (3) teamwork, cooperation and positive working relationships; (4) constant reinforcing of safe, ethical and respectful behaviours; (5) multiple problem-sensing systems, used as basis of action; (6) systems and processes designed for safety, and regularly reviewed and optimised; (7) effective coordination and ability to mobilise quickly. These features appear to have a synergistic character, such that each feature is necessary but not sufficient on its own: the features operate in concert through multiple forms of feedback and amplification. Conclusions: This large qualitative study has enabled the generation of a new plain language framework—For Us—that identifies the behaviours and practices that appear to be features of safe care in hospital-based maternity units

Risk factors associated with adverse fetal outcomes in pregnancies affected by Coronavirus disease 2019 (COVID-19): a secondary analysis of the WAPM study on COVID-19.

Objectives To evaluate the strength of association between maternal and pregnancy characteristics and the risk of adverse perinatal outcomes in pregnancies with laboratory confirmed COVID-19. Methods Secondary analysis of a multinational, cohort study on all consecutive pregnant women with laboratory-confirmed COVID-19 from February 1, 2020 to April 30, 2020 from 73 centers from 22 different countries. A confirmed case of COVID-19 was defined as a positive result on real-time reverse-transcriptase-polymerase-chain-reaction (RT-PCR) assay of nasal and pharyngeal swab specimens. The primary outcome was a composite adverse fetal outcome, defined as the presence of either abortion (pregnancy loss before 22 weeks of gestations), stillbirth (intrauterine fetal death after 22 weeks of gestation), neonatal death (death of a live-born infant within the first 28 days of life), and perinatal death (either stillbirth or neonatal death). Logistic regression analysis was performed to evaluate parameters independently associated with the primary outcome. Logistic regression was reported as odds ratio (OR) with 95% confidence interval (CI). Results Mean gestational age at diagnosis was 30.6+/-9.5 weeks, with 8.0% of women being diagnosed in the first, 22.2% in the second and 69.8% in the third trimester of pregnancy. There were six miscarriage (2.3%), six intrauterine device (IUD) (2.3) and 5 (2.0%) neonatal deaths, with an overall rate of perinatal death of 4.2% (11/265), thus resulting into 17 cases experiencing and 226 not experiencing composite adverse fetal outcome. Neither stillbirths nor neonatal deaths had congenital anomalies found at antenatal or postnatal evaluation. Furthermore, none of the cases experiencing IUD had signs of impending demise at arterial or venous Doppler. Neonatal deaths were all considered as prematurity-related adverse events. Of the 250 live-born neonates, one (0.4%) was found positive at RT-PCR pharyngeal swabs performed after delivery. The mother was tested positive during the third trimester of pregnancy. The newborn was asymptomatic and had negative RT-PCR test after 14 days of life. At logistic regression analysis, gestational age at diagnosis (OR: 0.85, 95% CI 0.8-0.9 per week increase; pPeer reviewe

Maternal and perinatal outcomes of pregnant women with SARS-CoV-2 infection

Objectives To evaluate the maternal and perinatal outcomes of pregnancies affected by SARS-CoV-2 infection. Methods This was a multinational retrospective cohort study including women with a singleton pregnancy and laboratory-confirmed SARS-CoV-2 infection, conducted in 72 centers in 22 different countries in Europe, the USA, South America, Asia and Australia, between 1 February 2020 and 30 April 2020. Confirmed SARS-CoV-2 infection was defined as a positive result on real-time reverse-transcription polymerase chain reaction (RT-PCR) assay of nasopharyngeal swab specimens. The primary outcome was a composite measure of maternal mortality and morbidity, including admission to the intensive care unit (ICU), use of mechanical ventilation and death. Results In total, 388 women with a singleton pregnancy tested positive for SARS-CoV-2 on RT-PCR of a nasopharyngeal swab and were included in the study. Composite adverse maternal outcome was observed in 47/388 (12.1%) women; 43 (11.1%) women were admitted to the ICU, 36 (9.3%) required mechanical ventilation and three (0.8%) died. Of the 388 women included in the study, 122 (31.4%) were still pregnant at the time of data analysis. Among the other 266 women, six (19.4% of the 31 women with first-trimester infection) had miscarriage, three (1.1%) had termination of pregnancy, six (2.3%) had stillbirth and 251 (94.4%) delivered a liveborn infant. The rate of preterm birth before 37 weeks' gestation was 26.3% (70/266). Of the 251 liveborn infants, 69/251(27.5%) were admitted to the neonatal ICU, and there were five (2.0%) neonatal deaths. The overall rate of perinatal death was 4.1% (11/266). Only one (1/251, 0.4%) infant, born to a mother who tested positive during the third trimester, was found to be positive for SARS-CoV-2 on RT-PCR. Conclusions SARS-CoV-2 infection in pregnant women is associated with a 0.8% rate of maternal mortality, but an 11.1% rate of admission to the ICU. The risk of vertical transmission seems to be negligible. (C) 2020 International Society of Ultrasound in Obstetrics and Gynecology.Peer reviewe

REORGANISING ITALIAN HOSPITALS TOWARD A PATIENT-CENTRED MODEL OF CARE: A STUDY OF THE SOCIAL ORGANISATION OF HOSPITAL WORK

Innovare verso un modello per Intensità delle Cure (IdC) offre agli ospedali importanti potenzialità di miglioramento, tanto a livello di qualità delle cure quanto sul piano organizzativo e gestionale. L’introduzione del modello IdC può tuttavia implicare sostanziali modifiche nell’organizzazione sociale del lavoro clinico, modificando relazioni, confini e identità professionali. La tesi esamina i reciproci effetti tra il modello IdC e l’organizzazione sociale del lavoro ospedaliero. Il disegno di ricerca è organizzato in tre fasi: una estensiva analisi documentale, uno studio esplorativo basato su interviste qualitative semi-strutturate, uno caso di studio etnografico in profondità condotto in un ospedale recentemente organizzato secondo il modello IdC. I risultati sono organizzati in tre studi. Il primo mostra come il cambiamento IdC sia stato diversamente interpretato dai manager ospedalieri e dai clinici in prima linea con i pazienti, costituendo così due discordanti ‘narrative di cambiamento’. Il secondo studio si focalizza sugli ostacoli alla creazione di team multidisciplinari negli ospedali IdC. Il terzo studio esamina l’impatto del modello IdC su relazioni e confini professionali tra medici e infermieri. Oltre a contribuire alle teorie socio-psicologiche riguardo a confini e identità professionali, la tesi propone riflessioni concrete su come colmare il divario tra programmi innovativi formali e pratiche di cura quotidiane.The Patient-Centred Model (PCM) is described as an attempt to redesign the hospitals around the needs of the patients, thus contributing to costs reduction, increased efficiency, and improved care. However, the introduction of the PCM may have a profound impact on the social organisation of work, changing lines of demarcation, challenging well established inter-/intra-professional relationships, and prompting the development of new roles and modes of working. This thesis explores the mutual effects between the new organisational model and the pre-existent social organisation of hospital work. The research design is organised in three phases: an extensive document analysis; an interview study; an in-depth ethnographic case study conducted for over one year in a PCM hospital. The findings are organised in three studies. The first shows that the PCM was interpreted differently by hospital managers and by frontline clinicians, thus giving rise to two divergent narratives of change. The second study focuses on the boundaries to collaboration and care integration in newly created hospital teams within PCM hospitals. The third study looks at the impact of the PCM on the medical-nursing boundary. The thesis contributes to management learning and practice by providing recommendations on how to accompany complex innovations, comprising of both their expected and unexpected consequences. It also enriches academic debates on professional boundaries, relations, and identities in healthcare

What is the potential of patient shadowing as a patient-centred method?

What is the potential of patient shadowing as a patient-centred method

L\u2019ospedale centrato sul paziente \ue8 ancora lontano: Migliorare la ricerca sulla medicina patient centered nelle organizzazioni sanitarie \ue8 una priorit\ue0

La centratura sul paziente oggi costituisce una dimensione cruciale della qualit\ue0 dei servizi di cura offerti dal sistema sanitario. Nonostante la mole di teorie e modelli che descrivono la cura centrata sul paziente, i risultati delle ricerche sembrano ancora incapaci di riflettere pienamente l\u2019esperienza dei pazienti negli ospedali. Da una parte, gli studi che si focalizzano sulle interazioni medico-paziente restituiscono descrizioni ideali delle relazioni di cura e non tengono conto dei vincoli locali e delle specificit\ue0 dei contesti. Dall\u2019altra, gli studi organizzativi producono teorie o modelli generali, che ipotizzano le dimensioni organizzative importanti per la centratura sul paziente, ma non indicano come tali variabili siano tradotte in pratica e rese effettive dai professionisti sanitari. Mutuando alcune proposte metodologiche dalla ricerca sociale, indichiamo sei direzioni per avvicinare la ricerca sulla patient centered medicine alla complessit\ue0 delle esperienze di pazienti e professionisti negli ospedali: tenere conto della specificit\ue0 dei contesti di cura; adottare metodi etnografici; sperimentare la tecnica osservativa dello shadowing; coinvolgere le organizzazioni sanitarie nella progettazione delle ricerche; usare i dati delle ricerche per rafforzare le capacit\ue0 riflessive dei professionisti; e prefigurare i cambiamenti organizzativi e politici implicati nell\u2019adozione di un approccio patient centered. Gli spunti delineati forniscono alcune indicazioni per andare verso percorsi di apprendimento-azione collaborativi e supportare un\u2019innovazione organizzativa che conduca a ospedali centrati sul paziente.t is widely acknowledged that patient centeredness is a key element of healthcare service quality. Despite the numerous theories describing patient centered care, the research outcomes in this field seem still unable to fully describe patients\u2019 overall experiences in the hospital. Studies that focus on the doctor-patient relationship often provide ideal and abstract descriptions of the relationship between patients and care providers, and fail to consider local contingencies and socio-cultural constraints. Organization-oriented studies succeed in identifying the main organizational levers for moving towards patient centered hospitals, but do not explain how health professionals can translate them into their daily activities. Drawing on social research methodology, we offer six proposals that could assist the research on patient centered medicine to approach the complexity of patients\u2019 and practitioners\u2019 experiences: consider the specificities of local contexts; use ethnographic methods; shadow patients and practitioners; engage healthcare organizations in designing the research; use research data to strengthen practitioners\u2019 reflective capacity; and prepare for the organizational change and power shifts that a patient centered approach involves. The proposals provide general guidance for both engaging in collaborative action-learning processes and for supporting organizational innovation that will lead to patient centered hospitals

PATIENT CENTERED VIRTUAL REALITY: AN OPPORTUNITY TO IMPROVE THE QUALITY OF PATIENT’S EXPERIENCE

The concept of Patient Centered Medicine today constitutes a crucial dimension of the health care system’s mission. The importance of overcoming a disease-centered approach is widely acknowledged, making essential for health practitioners and organizations to involve patients in their care plans, to explore patients’ preferences and concerns and to consider the patient as a whole person, with his/her emotional needs and life issues. In fact, there is evidence that these aspects are crucial for ensuring the quality and effectiveness of the process of care. It is also widely accepted that technologies can have a role in enabling a patient centered approach. We argue that Virtual Reality (VR) technologies are particularly suitable to help health care practitioners and organizations in advancing toward patient centeredness. Basing on the literature on VR in health care settings, we review VR tools that aim to support patients in dealing with their illness experience instead than addressing a specific pathology. We describe (1) pain management methods and (2) rehabilitation techniques as therapeutic interventions that share the potentiality of enabling a patient centered approach. We then consider the use of virtual environments in educational intervention directed to care providers, and specifically to train health professionals in patient-centered relational and communicational competences. In conclusion, we highlight new directions and implications for future uses of virtual reality in health care settings. Specifically, we elaborate on the parallelism between the concept of patient centeredness and the usercentered approaches in the design of technologies, suggesting innovative strategies to involve patients and health practitioners in the design of the future VR tools