International Delphi Expert Consensus on Safe Return to Surgical and Endoscopic Practice: From the Coronavirus Global Surgical Collaborative.

OBJECTIVE: The aim of this work is to formulate recommendations based on global expert consensus to guide the surgical community on the safe resumption of surgical and endoscopic activities. BACKGROUND: The COVID-19 pandemic has caused marked disruptions in the delivery of surgical care worldwide. A thoughtful, structured approach to resuming surgical services is necessary as the impact of COVID-19 becomes better controlled. The Coronavirus Global Surgical Collaborative sought to formulate, through rigorous scientific methodology, consensus-based recommendations in collaboration with a multidisciplinary group of international experts and policymakers. METHODS: Recommendations were developed following a Delphi process. Domain topics were formulated and subsequently subdivided into questions pertinent to different aspects of surgical care in the COVID-19 crisis. Forty-four experts from 15 countries across 4 continents drafted statements based on the specific questions. Anonymous Delphi voting on the statements was performed in 2 rounds, as well as in a telepresence meeting. RESULTS: One hundred statements were formulated across 10 domains. The statements addressed terminology, impact on procedural services, patient/staff safety, managing a backlog of surgeries, methods to restart and sustain surgical services, education, and research. Eighty-three of the statements were approved during the first round of Delphi voting, and 11 during the second round. A final telepresence meeting and discussion yielded acceptance of 5 other statements. CONCLUSIONS: The Delphi process resulted in 99 recommendations. These consensus statements provide expert guidance, based on scientific methodology, for the safe resumption of surgical activities during the COVID-19 pandemic.

SOBRINA Spanish study-analysing the frequency, cost and adverse events associated with overuse in primary care: protocol for a retrospective cohort study.

INTRODUCTION: Several institutions and quality national agencies have fostered the creation of recommendations on what not to do to reduce overuse in clinical practice. In primary care, their impact has hardly been studied. The frequency of adverse events (AEs) associated with doing what must not be done has not been analysed, either. The aim of this study is to measure the frequency of overuse and AEs associated with doing what must not be done (commission errors) in primary care and their cost. METHODS AND ANALYSIS: A coordinated, multicentric, national project. A retrospective cohort study using computerised databases of primary care medical records from national agencies and regional health services will be conducted to analyse the frequency of the overuse due to ignore the do-not-do recommendations, and immediately afterwards, depending on their frequency, a representative random sample of medical records will be reviewed with algorithms (triggers) that determine the frequency of AEs associated with these recommendations. Cost will determine by summation of the direct costs due to the consultation, pharmacy, laboratory and imaging activities according to the cases. ETHICS AND DISSEMINATION: The study protocol has been approved by the Ethics Committee of Primary Care Research of the Valencian Community. We aim to disseminate the findings through international peer-reviewed journals and on the website (http://www.nohacer.es/). Outcomes will be used to incorporate algorithms into the electronic history to assist in making clinical decisions. TRIAL REGISTRATION NUMBER: NCT03482232; Pre-results.

Low-value clinical practices and harm caused by non-adherence to 'do not do' recommendations in primary care in Spain: a Delphi study.

OBJECTIVE: To determine the non-adherence to the primary care 'do not do' recommendations (DNDs) and their likelihood to cause harm. DESIGN: Delphi study. SETTING: Spanish National Health System. PARTICIPANTS: A total of 128 professionals were recruited (50 general practitioners [GPs], 28 pediatricians [PEDs], 31 nurses who care for adult patients [RNs] and 19 pediatric nurses [PNs]). INTERVENTIONS: A selection of 27 DNDs directed at GPs, 8 at PEDs, 9 at RNs and 4 at PNs were included in the Delphi technique. A 10-point scale was used to assess whether a given practice was still present and the likelihood of it causing of an adverse event. MAIN OUTCOME MEASURE: Impact calculated by multiplying an event's frequency and likelihood to cause harm. RESULTS: A total of 100 professionals responded to wave 1 (78% response rate) and 97 of them to wave 2 (97% response rate). In all, 22% (6/27) of the practices for GPs, 12% (1/8) for PEDs, 33% (3/9) for RNs and none for PNs were cataloged as frequent. A total of 37% (10/27) of these practices for GPs, 25% (2/8) for PEDs, 33% (3/9) for RNs and 25% (1/4) for PNs were considered as potential causes of harm. Only 26% (7/27) of the DNDs for GPs showed scores equal to or higher than 36 points. The impact measure was higher for ordering benzodiazepines to treat insomnia, agitation or delirium in elderly patients (mean = 57.8, SD = 25.3). CONCLUSIONS: Low-value and potentially dangerous practices were identified; avoiding these could improve care quality.

E-learning on risk management. An opportunity for sharing knowledge and experiences in patient safety.

QUALITY PROBLEM: E-learning methodology is a good alternative to more traditional methods when economical restrictions and geographical dispersion are important. However, there is still little knowledge about its utility in the development of patient safety (PS) improvement projects. INITIAL ASSESSMENT: Evaluation of the acceptability and utility of an e-learning risk management (RM) course for healthcare professionals to develop PS improvement projects in different clinical settings. CHOICE OF SOLUTION: E-course offered, in Spanish and English, to facilitate the design of PS improvement projects using RM tools under the continuous support of PS experts. IMPLEMENTATION: The evaluation of the course was based on the reaction, learning and healthcare professional behavior. A free online database was created to disseminate and share the projects developed during the course. EVALUATION: A total of 1426 professionals have completed the course (84.2%), of which 86.7% (1236) were from Spain, 8.3% (118) from Latin America and 5% (72) from other European and Eastern Mediterranean countries. More than 80% of the students were very satisfied with the e-course and 98% would recommend it to their colleagues. Learning and developing improvement projects through teamwork was highlighted as a very positive aspect. A total of 70.3% of the 387 PSIP were developed in hospitals. The most frequent topic was medication. LESSON LEARNED: Team learning based on real cases was one of the most positive aspects of the e-course. The improvement projects developed are transferable examples of good practices that facilitate the application of RM tools in different clinical settings.

Prevention of Ventilator-Associated Pneumonia: The Multimodal Approach of the Spanish ICU "Pneumonia Zero" Program.

OBJECTIVES: The "Pneumonia Zero" project is a nationwide multimodal intervention based on the simultaneous implementation of a comprehensive evidence-based bundle measures to prevent ventilator-associated pneumonia in critically ill patients admitted to the ICU. DESIGN: Prospective, interventional, and multicenter study. SETTING: A total of 181 ICUs throughout Spain. PATIENTS: All patients admitted for more than 24 hours to the participating ICUs between April 1, 2011, and December 31, 2012. INTERVENTION: Ten ventilator-associated pneumonia prevention measures were implemented (seven were mandatory and three highly recommended). The database of the National ICU-Acquired Infections Surveillance Study (Estudio Nacional de Vigilancia de Infecciones Nosocomiales [ENVIN]) was used for data collection. Ventilator-associated pneumonia rate was expressed as incidence density per 1,000 ventilator days. Ventilator-associated pneumonia rates from the incorporation of the ICUs to the project, every 3 months, were compared with data of the ENVIN registry (April-June 2010) as the baseline period. Ventilator-associated pneumonia rates were adjusted by characteristics of the hospital, including size, type (public or private), and teaching (postgraduate) or university-affiliated (undergraduate) status. MEASUREMENTS AND MAIN RESULTS: The 181 participating ICUs accounted for 75% of all ICUs in Spain. In a total of 171,237 ICU admissions, an artificial airway was present on 505,802 days (50.0% of days of stay in the ICU). A total of 3,474 ventilator-associated pneumonia episodes were diagnosed in 3,186 patients. The adjusted ventilator-associated pneumonia incidence density rate decreased from 9.83 (95% CI, 8.42-11.48) per 1,000 ventilator days in the baseline period to 4.34 (95% CI, 3.22-5.84) after 19-21 months of participation. CONCLUSIONS: Implementation of the bundle measures included in the "Pneumonia Zero" project resulted in a significant reduction of more than 50% of the incidence of ventilator-associated pneumonia in Spanish ICUs. This reduction was sustained 21 months after implementation.

Developing a list of high-alert medications for patients with chronic diseases.

BACKGROUND: Patients with chronic diseases often receive multiple medications and are associated with increased vulnerability to medication errors. Identifying high-alert medications for them would help to prioritize the interventions with greatest impact for improving medication safety. The aim of this study was to develop a list of high-alert medications for patients with chronic illnesses (HAMC list) that would prove useful to the Spanish National Health Service strategies on chronicity. METHODS: The RAND/UCLA appropriateness method was used. Drug classes/drugs candidates to be included on the HAMC list were identified from a literature search in MedLine, bulletins issued by patient safety organizations, incidents recorded in Spanish incident reporting systems, and previous lists. Eighteen experts in patient/medication safety or in chronic diseases scored candidate drugs for appropriateness according to three criteria (evidence, benefit and feasibility of implementing safety practices). Additionally they rated their priority of inclusion on a Likert scale. RESULTS: The final HAMC list includes 14 drug classes (oral anticoagulants, narrow therapeutic range antiepileptics, antiplatelets - including aspirin -, antipsychotics, ß-blockers, benzodiazepines and analogues, corticosteroids long-term use, oral cytostatics, oral hypoglycemic drugs, immunosuppressants, insulins, loop diuretics, nonsteroidal anti-inflammatory drugs, and opioid analgesics), and 4 drugs or pairs of drugs (amiodarone/ dronedarone, digoxin, oral methotrexate and spironolactone/eplerenone). CONCLUSIONS: An initial list of high-alert medications for patients with chronic diseases has been developed, which can be built into the medication management strategies for chronicity to guide the implementation of efficient safety strategies and to identify those patients at greater risk for preventable adverse drug events.

Lessons learnt from the development of the Patient Safety Incidents Reporting an Learning System for the Spanish National Health System: SiNASP.

OBJECTIVE: To describe the development process and characteristics of a patient safety incidents reporting system to be implemented in the Spanish National Health System, based on the context and the needs of the different stakeholders. DESIGN: Literature review and analysis of most relevant reporting systems, identification of more than 100 stakeholder's (patients, professionals, regional governments representatives) expectations and requirements, analysis of the legal context, consensus of taxonomy, development of the software and pilot test. RESULTS: Patient Safety Events Reporting and Learning system (Sistema de Notificación y Aprendizajepara la Seguridad del Paciente, SiNASP) is a generic reporting system for all types of incidents related to patient safety, voluntary, confidential, non punitive, anonymous or nominative with anonimization, system oriented, with local analysis of cases and based on the WHO International Classification for Patient Safety. The electronic program has an on-line form for reporting, a software to manage the incidents and improvement plans, and a scoreboard with process indicators to monitor the system. CONCLUSIONS: The reporting system has been designed to respond to the needs and expectations identified by the stakeholders, taking into account the lessons learned from the previous notification systems, the characteristics of the National Health System and the existing legal context. The development process presented and the characteristics of the system provide a comprehensive framework that can be used for future deployments of similar patient safety systems.

Impact of a national multimodal intervention to prevent catheter-related bloodstream infection in the ICU: the Spanish experience.

OBJECTIVE: Prevention of catheter-related bloodstream infection is a basic objective to optimize patient safety in the ICU. Building on the early success of a patient safety unit-based comprehensive intervention (the Keystone ICU project in Michigan), the Bacteremia Zero project aimed to assess its effectiveness after contextual adaptation at large-scale implementation in Spanish ICUs. DESIGN: Prospective time series. SETTING: A total of 192 ICUs throughout Spain. PATIENTS: All patients admitted to the participating ICUs during the study period (baseline April 1 to June 30, 2008; intervention period from January 1, 2009, to June 30, 2010). INTERVENTION: Engagement, education, execution, and evaluation were key program features. Main components of the intervention included a bundle of evidence-based clinical practices during insertion and maintenance of catheters and a unit-based safety program (including patient safety training and identification and analysis of errors through patient safety rounds) to improve the safety culture. MEASUREMENTS AND MAIN RESULTS: The number of catheter-related bloodstream infections was expressed as median and interquartile range. Poisson distribution was used to calculate incidence rates and risk estimates. The participating ICUs accounted for 68% of all ICUs in Spain. Catheter-related bloodstream infection was reduced after 16-18 months of participation (median 3.07 vs 1.12 episodes per 1,000 catheter-days, p<0.001). The adjusted incidence rate of bacteremia showed a 50% risk reduction (95% CI, 0.39-0.63) at the end of the follow-up period compared with baseline. The reduction was independent of hospital size and type. CONCLUSIONS: Results of the Bacteremia Zero project confirmed that the intervention significantly reduced catheter-related bloodstream infection after large-scale implementation in Spanish ICUs. This study suggests that the intervention can also be effective in different socioeconomic contexts even with decentralized health systems.

A study of the prevalence of adverse events in primary healthcare in Spain.

BACKGROUND: Healthcare practices involve risks for patients, but there has been little research to date on the occurrence of adverse events (AE) in primary care (PC). The frequency of AE in PC in Spain, the factors that contribute to their occurrence, their severity and their preventability, were analysed. METHODS: Observational cross-sectional study was carried out in 48 PC centres in 16 regions of Spain. PC professionals were asked to assess whether the AE was caused by the healthcare or if it was an expectable consequence of the patient's underlying condition. A total of 452 healthcare professionals who attended 96 047 consultations were involved. RESULTS: A total of 773 AE were identified, so that the point prevalence of AE was 0.8% [95% confidence interval (CI) 0.76-0.85]. A majority of AE (64.3%) were considered preventable and only 5.9% were severe, usually related to medication [odds ratio (OR) = 4.6; 95% CI 2.1-10.3]. The most frequent causal factor of the AE was associated with medication (adverse drug reactions and medication errors), but problems in communication and management were at the root of many of the AE. Nurses reported more preventable AE (OR = 1.9; 95% CI 1.2-2.8). CONCLUSION: In spite of an AE being less damaging in PC, large numbers of patients and professionals suffer their consequences each year. An awareness of the magnitude and impact of AE is the first step on the road to the cultural change necessary for achieving safer healthcare.

Effects of online palliative care training on knowledge, attitude and satisfaction of primary care physicians.

BACKGROUND: The Spanish Palliative Care Strategy recommends an intermediate level of training for primary care physicians in order to provide them with knowledge and skills. Most of the training involves face-to-face courses but increasing pressures on physicians have resulted in fewer opportunities for provision of and attendance to this type of training. The effectiveness of on-line continuing medical education in terms of its impact on clinical practice has been scarcely studied. Its effect in relation to palliative care for primary care physicians is currently unknown, in terms of improvement in patient's quality of life and main caregiver's satisfaction. There is uncertainty too in terms of any potential benefits of asynchronous communication and interaction among on-line education participants, as well as of the effect of the learning process.The authors have developed an on-line educational model for palliative care which has been applied to primary care physicians in order to measure its effectiveness regarding knowledge, attitude towards palliative care, and physician's satisfaction in comparison with a control group.The effectiveness evaluation at 18 months and the impact on the quality of life of patients managed by the physicians, and the main caregiver's satisfaction will be addressed in a different paper. METHODS: Randomized controlled educational trial to compared, on a first stage, the knowledge and attitude of primary care physicians regarding palliative care for advanced cancer patients, as well as satisfaction in those who followed an on-line palliative care training program with tutorship, using a Moodle Platform vs. traditional education. RESULTS: 169 physicians were included, 85 in the intervention group and 84 in the control group, of which five were excluded. Finally 82 participants per group were analyzed. There were significant differences in favor of the intervention group, in terms of knowledge (mean 4.6; CI 95%: 2.8 to 6.5 (p = 0.0001), scale range 0-33), confidence in symptom management (p = 0.02) and confidence in terms of communication (p = 0.038). Useful aspects were pointed out, as well as others to be improved in future applications. The satisfaction of the intervention group was high. CONCLUSIONS: The results of this study show that there was a significant increase of knowledge of 14%-20% and a significant increase in the perception of confidence in symptom management and communication in the intervention group in comparison with the control group that received traditional methods of education in palliative care or no educational activity at all. The overall satisfaction with the intervention was good-very good for most participants.This on-line educational model seems a useful tool for palliative care training in primary care physicians who have a high opinion about the integration of palliative care within primary care. The results of this study support the suggestion that learning effectiveness should be currently investigated comparing different Internet interventions, instead of Internet vs. no intervention.

Systematic review of educational interventions in palliative care for primary care physicians.

BACKGROUND: A literature review of educational interventions in palliative care (PC) for primary care physicians (PCP) was performed, to evaluate its impact in changing professional practice. METHODS: Studies undertaking any educational intervention in PC by PCP, published between 1966 and February 2005, identified through Medline, EMBASE, Cochrane Database of Systematic Reviews and Clinical Trials, Educational Resources Information Centre, Research and Development Resource Base in Continuing Medical Education, Spanish Medical Index, using a combined text word and MESH heading search strategy. RESULTS: Eighteen articles were included with 1653 physicians. Educative methods were: role model training, small group discussions, and distribution of guidelines. Quality of the studies was low. Opioids prescription improved in two studies. Discrepancies were shown between the perception of PCP in symptom management, determined through questionnaires, and the data concerning opioids prescription. Knowledge improved in all studies. Some benefit of multifaceted approach was stated. Carers were satisfied, in general, with the PCP care, but dissatisfied with patients' pain control. CONCLUSION: PC education for PCP is poorly studied. Adequate research designs are necessary in future studies with objective outcomes and patient opinion.