Lessons learned for reducing the negative impact of adverse events on patients, health professionals and healthcare organizations.

PURPOSE: To summarize the knowledge about the aftermath of adverse events (AEs) and develop a recommendation set to reduce their negative impact in patients, health professionals and organizations in contexts where there is no previous experiences and apology laws are not present. DATA SOURCES: Review studies published between 2000 and 2015, institutional websites and experts' opinions on patient safety. STUDY SELECTION: Studies published and websites on open disclosure, and the second and third victims' phenomenon. Four Focus Groups participating 27 healthcare professionals. DATA EXTRACTION: Study characteristic and outcome data were abstracted by two authors and reviewed by the research team. RESULTS OF DATA SYNTHESIS: Fourteen publications and 16 websites were reviewed. The recommendations were structured around eight areas: (i) safety and organizational policies, (ii) patient care, (iii) proactive approach to preventing reoccurrence, (iv) supporting the clinician and healthcare team, (v) activation of resources to provide an appropriate response, (vi) informing patients and/or family members, (vii) incidents' analysis and (viii) protecting the reputation of health professionals and the organization. CONCLUSION: Recommendations preventing aftermath of AEs have been identified. These have been designed for the hospital and the primary care settings; to cope with patient's emotions and for tacking the impact of AE in the second victim's colleagues. Its systematic use should help for the establishment of organizational action plans after an AE.

The Second Victim Phenomenon After a Clinical Error: The Design and Evaluation of a Website to Reduce Caregivers' Emotional Responses After a Clinical Error.

BACKGROUND: Adverse events (incidents that harm a patient) can also produce emotional hardship for the professionals involved (second victims). Although a few international pioneering programs exist that aim to facilitate the recovery of the second victim, there are no known initiatives that aim to raise awareness in the professional community about this issue and prevent the situation from worsening. OBJECTIVE: The aim of this study was to design and evaluate an online program directed at frontline hospital and primary care health professionals that raises awareness and provides information about the second victim phenomenon. METHODS: The design of the Mitigating Impact in Second Victims (MISE) online program was based on a literature review, and its contents were selected by a group of 15 experts on patient safety with experience in both clinical and academic settings. The website hosting MISE was subjected to an accreditation process by an external quality agency that specializes in evaluating health websites. The MISE structure and content were evaluated by 26 patient safety managers at hospitals and within primary care in addition to 266 frontline health care professionals who followed the program, taking into account its comprehension, usefulness of the information, and general adequacy. Finally, the amount of knowledge gained from the program was assessed with three objective measures (pre- and posttest design). RESULTS: The website earned Advanced Accreditation for health websites after fulfilling required standards. The comprehension and practical value of the MISE content were positively assessed by 88% (23/26) and 92% (24/26) of patient safety managers, respectively. MISE was positively evaluated by health care professionals, who awarded it 8.8 points out of a maximum 10. Users who finished MISE improved their knowledge on patient safety terminology, prevalence and impact of adverse events and clinical errors, second victim support models, and recommended actions following a severe adverse event (P<.001). CONCLUSIONS: The MISE program differs from existing intervention initiatives by its preventive nature in relation to the second victim phenomenon. Its online nature makes it an easily accessible tool for the professional community. This program has shown to increase user's knowledge on this issue and it helps them correct their approach. Furthermore, it is one of the first initiatives to attempt to bring the second victim phenomenon closer to primary care.

Measures to Assure that Ebola Guidelines Are Correctly Applied.

OBJECTIVE: The purpose of this study was to assure the application, in our primary care health district, of the World Health Organisation and Spanish Ebola virus disease (EVD) guidelines, and to identify and resolve gaps, in order to protect professionals from the risks associated with attending to patients with Ebola. MATERIALS AND METHODS: A checklist was drawn up and an audit procedure of the structural, functional and operational conditions was designed for managing a self-presenting patient suspected with EVD in general practice. This audit was applied twice (before and after assessment) in 9 health centres of a health district in Spain. The checklist was structured according to 9 categories (51 elements in total). This tool was designed to avoid errors in the management of EVD patients that are considered very serious in view of their potential consequences. RESULTS: Of the 51 elements on the checklist, 7-26 (14-51%) required direct intervention to rectify deficits in the first audit. The following elements requiring improvement were identified: the incorporation of memory aids to ensure the correct application of the EVD protocol, defining what information should be provided to the patient and (where applicable) anyone accompanying them as well as incorporating advice on how to deal with any individuals with whom they might have come into contact. A second audit assured the adequacy of the proposed solutions. CONCLUSION: In this study, the tool achieved the successful application of EVD protocol, assuring that primary care centres were able to handle an Ebola suspect patient safely.

The aftermath of adverse events in Spanish primary care and hospital health professionals.

BACKGROUND: Adverse events (AEs) cause harm in patients and disturbance for the professionals involved in the event (second victims). This study assessed the impact of AEs in primary care (PC) and hospitals in Spain on second victims. METHODS: A cross-sectional study was conducted. We carried out a survey based on a random sample of doctors and nurses from PC and hospital settings in Spain. A total of 1087 health professionals responded, 610 from PC and 477 from hospitals. RESULTS: A total of 430 health professionals (39.6%) had informed a patient of an error. Reporting to patients was carried out by those with the strongest safety culture (Odds Ratio -OR- 1.1, 95% Confidence Interval -CI- 1.0-1.2), nurses (OR 1.9, 95% CI 1.5-2.3), those under 50 years of age (OR 0.7, 95% CI 0.6-0.9) and primary care staff (OR 0.6, 95% CI 0.5-0.9). A total of 381 (62.5%, 95% CI 59-66%) and 346 (72.5%, IC95% 69-77%) primary care and hospital health professionals, respectively, reported having gone through the second-victim experience, either directly or through a colleague, in the previous 5 years. The emotional responses were: feelings of guilt (521, 58.8%), anxiety (426, 49.6%), re-living the event (360, 42.2%), tiredness (341, 39.4%), insomnia (317, 38.0%) and persistent feelings of insecurity (284, 32.8%). In doctors, the most common responses were: feelings of guilt (OR 0.7 IC95% 0.6-0.8), re-living the event (OR 0.7, IC95% o.6-0.8), and anxiety (OR 0.8, IC95% 0.6-0.9), while nurses showed greater solidarity in terms of supporting the second victim, in both PC (p = 0.019) and hospital (p = 0.019) settings. CONCLUSIONS: Adverse events cause guilt, anxiety, and loss of confidence in health professionals. Most are involved in such events as second victims at least once in their careers. They rarely receive any training or education on coping strategies for this phenomenon.

Interventions in health organisations to reduce the impact of adverse events in second and third victims.

BACKGROUND: Adverse events (AE) are also the cause of suffering in health professionals involved. This study was designed to identify and analyse organization-level strategies adopted in both primary care and hospitals in Spain to address the impact of serious AE on second and third victims. METHODS: A cross-sectional study was conducted in healthcare organizations assessing: safety culture; health organization crisis management plans for serious AE; actions planned to ensure transparency in communication with patients (and relatives) who experience an AE; support for second victims; and protective measures to safeguard the institution's reputation (the third victim). RESULTS: A total of 406 managers and patient safety coordinators replied to the survey. Deficient provision of support for second victims was acknowledged by 71 and 61% of the participants from hospitals and primary care respectively; these respondents reported there was no support protocol for second victims in place in their organizations. Regarding third victim initiatives, 35% of hospital and 43% of primary care professionals indicated no crisis management plan for serious AE existed in their organization, and in the case of primary care, there was no crisis committee in 34% of cases. The degree of implementation of second and third victim support interventions was perceived to be greater in hospitals (mean 14.1, SD 3.5) than in primary care (mean 11.8, SD 3.1) (p < 0.001). CONCLUSIONS: Many Spanish health organizations do not have a second and third victim support or a crisis management plan in place to respond to serious AEs.

A Spanish-language patient safety questionnaire to measure medical and nursing students' attitudes and knowledge.

OBJECTIVE: To design and validate a questionnaire for assessing attitudes and knowledge about patient safety using a sample of medical and nursing students undergoing clinical training in Spain and four countries in Latin America. METHODS: In this cross-sectional study, a literature review was carried out and total of 786 medical and nursing students were surveyed at eight universities from five countries (Chile, Colombia, El Salvador, Guatemala, and Spain) to develop and refine a Spanish-language questionnaire on knowledge and attitudes about patient safety. The scope of the questionnaire was based on five dimensions (factors) presented in studies related to patient safety culture found in PubMed and Scopus. Based on the five factors, 25 reactive items were developed. Composite reliability indexes and Cronbach's alpha statistics were estimated for each factor, and confirmatory factor analysis was conducted to assess validity. After a pilot test, the questionnaire was refined using confirmatory models, maximum-likelihood estimation, and the variance-covariance matrix (as input). Multiple linear regression models were used to confirm external validity, considering variables related to patient safety culture as dependent variables and the five factors as independent variables. RESULTS: The final instrument was a structured five-point Likert self-administered survey (the "Latino Student Patient Safety Questionnaire") consisting of 21 items grouped into five factors. Compound reliability indexes (Cronbach's alpha statistic) calculated for the five factors were about 0.7 or higher. The results of the multiple linear regression analyses indicated good model fit (goodness-of-fit index: 0.9). Item-total correlations were higher than 0.3 in all cases. The convergent-discriminant validity was adequate. CONCLUSIONS: The questionnaire designed and validated in this study assesses nursing and medical students' attitudes and knowledge about patient safety. This instrument could be used to indirectly evaluate whether or not students in health disciplines are acquiring and thus likely to put into practice the professional skills currently considered most appropriate for patient safety.

Barriers for an effective communication around clinical decision making: an analysis of the gaps between doctors' and patients' point of view.

BACKGROUND: There are doubts on whether patients feel that they have sufficient information for actively participating in clinical decisions. OBJECTIVE: To describe the type of information that patients receive. To determine whether patients consider this information sufficient, and whether it contributes or not to improve clinical safety. To identify the barriers for patient participation in clinical decision making. STUDY DESIGN: Cross-sectional study with 764 patients and 327 physicians. STUDY SETTING AND PARTICIPANTS: Fourteen health centres belonging to three primary care districts and three hospitals in Spain. PRINCIPAL FINDINGS: Just 35.1% (268) (95% CI 32.2, 39.1%) of patients preferred to have the last word in clinical decisions. Age (39 vs. 62%, P < 0.001) and severity of illness (38 vs. 46%, P = 0.002) increased the tendency to take a passive role. In 85.1% (650) (95% CI 83.3, 88.3%) of the cases, patients reported having received sufficient information. Lack of consultation time (29.6%, 95% CI 25.8, 32.5%) and patients' use of Internet or other sources (19.2%, 95% CI 16.4, 22.2%) were identified as new obstacles to doctor-patient communication by the patients. Only 19.6% (64) (95% CI 15.4, 24.2%) of doctors considered that they could intervene to involve patients in the decisions. DISCUSSIONS AND CONCLUSIONS: The majority of patients prefer the decisions to be made by their doctor, especially those with more severe illnesses, and older patients. Patients are not normally informed about medication interactions, precautions and foreseeable complications. The information provided by general practitioners does not seem to contribute enough to the patient involvement in clinical safety.

A Spanish pillbox app for elderly patients taking multiple medications: randomized controlled trial.

BACKGROUND: Nonadherence and medication errors are common among patients with complex drug regimens. Apps for smartphones and tablets are effective for improving adherence, but they have not been tested in elderly patients with complex chronic conditions and who typically have less experience with this type of technology. OBJECTIVE: The objective of this study was to design, implement, and evaluate a medication self-management app (called ALICE) for elderly patients taking multiple medications with the intention of improving adherence and safe medication use. METHODS: A single-blind randomized controlled trial was conducted with a control and an experimental group (N=99) in Spain in 2013. The characteristics of ALICE were specified based on the suggestions of 3 nominal groups with a total of 23 patients and a focus group with 7 professionals. ALICE was designed for Android and iOS to allow for the personalization of prescriptions and medical advice, showing images of each of the medications (the packaging and the medication itself) together with alerts and multiple reminders for each alert. The randomly assigned patients in the control group received oral and written information on the safe use of their medications and the patients in the experimental group used ALICE for 3 months. Pre and post measures included rate of missed doses and medication errors reported by patients, scores from the 4-item Morisky Medication Adherence Scale (MMAS-4), level of independence, self-perceived health status, and biochemical test results. In the experimental group, data were collected on their previous experience with information and communication technologies, their rating of ALICE, and their perception of the level of independence they had achieved. The intergroup intervention effects were calculated by univariate linear models and ANOVA, with the pre to post intervention differences as the dependent variables. RESULTS: Data were obtained from 99 patients (48 and 51 in the control and experimental groups, respectively). Patients in the experimental group obtained better MMAS-4 scores (P<.001) and reported fewer missed doses of medication (P=.02). ALICE only helped to significantly reduce medication errors in patients with an initially higher rate of errors (P<.001). Patients with no experience with information and communication technologies reported better adherence (P<.001), fewer missed doses (P<.001), and fewer medication errors (P=.02). The mean satisfaction score for ALICE was 8.5 out of 10. In all, 45 of 51 patients (88%) felt that ALICE improved their independence in managing their medications. CONCLUSIONS: The ALICE app improves adherence, helps reduce rates of forgetting and of medication errors, and increases perceived independence in managing medication. Elderly patients with no previous experience with information and communication technologies are capable of effectively using an app designed to help them take their medicine more safely. TRIAL REGISTRATION: Clinicaltrials.gov NCT02071498; http://clinicaltrials.gov/ct2/show/NCT02071498.

Hospital reputation and perceptions of patient safety.

OBJECTIVE: The objective of this study was to explore the theoretical relationship between the social reputation and the perceived safety of a hospital. SUBJECTS AND METHODS: A random sample of 316 patients and 27 relatives of patients who were unable to respond themselves at four public hospitals in Madrid, Barcelona and Alicante were interviewed to establish a measure of reputation and perceived safety. RESULTS: There were no different perceptions between patients and relatives regarding hospital reputation or safety perception (p > 0.05). The perception of patients or relatives of health professionals' competence (ß = 0.07, 95% CI 0.01-0.12), the perception of a positive treatment output of surgical or medical treatment (ß = 0.35, 95% CI 0.22-0.49) and hospital reputation (ß = 0.08, 95% CI 0.02-0.14) were directly and positively associated with their perception that the hospital was a safe clinical environment in which few clinical errors are committed. CONCLUSIONS: The data suggested that the social reputation of these hospitals and the perceptions of patients or relatives of patient safety were indeed correlated. Future research should assess whether efforts to enhance hospital reputation, by improving patients' perceptions of clinical safety, may contribute to reducing the frequency of litigation cases.

Oversights, confusions and misinterpretations related to self-care and medication in diabetic and renal patients.

OBJECTIVE: To analyse information about the errors made by diabetic and renal patients based on information provided by professionals (general practitioners, specialists, and nurses) and the patients themselves. SUBJECTS AND METHODS: A descriptive study was carried out by interviewing 199 patients and 60 professionals from the Spanish provinces of Alicante and Madrid. The interview explored the frequencies and types of oversights, confusions, and misinterpretations and the factors that contributed to them. RESULTS: Among the 199 patients, 59 (29.5%) and 42 (70%) of the 60 professionals considered that patients frequently made errors that affected the success of their treatment. There were no differences in the frequency of the reported errors based on gender (p = 0.7), educational level (p = 0.9), or marital status (p = 0.5). The most commonly reported errors were taking the wrong medication (n = 70; 35%) and mixing up medicines (n = 15; 7.5%). Diabetics who had not been adequately informed, compared to renal patients, reported a higher number of errors (p = 0.02). CONCLUSIONS: Patient errors were frequent because of communication failures and confusions. Diabetic patients had a higher chance of committing an error than renal patients. Patient education must include clear and personalized instructions for improving self-care and reducing risks when using medicines.

The European Researchers' Network Working on Second Victim (ERNST) Policy Statement on the Second Victim Phenomenon for Increasing Patient Safety.

Background: The second victim phenomenon refers to the emotional trauma healthcare professionals experience following adverse events (AEs) in patient care, which can compromise their ability to provide safe care. This issue has significant implications for patient safety, with AEs leading to substantial human and economic costs. Analysis: Current evidence indicates that AEs often result from systemic failures, profoundly affecting healthcare workers. While patient safety initiatives are in place, the psychological impact on healthcare professionals remains inadequately addressed. The European Researchers' Network Working on Second Victims (ERNST) emphasizes the need to support these professionals through peer support programs, systemic changes, and a shift toward a just culture in healthcare settings. Policy Options: Key options include implementing peer support programs, revising the legal framework to decriminalize honest errors, and promoting just culture principles. These initiatives aim to mitigate the second victim phenomenon, enhance patient safety, and reduce healthcare costs. Conclusion: Addressing the second victim phenomenon is essential for ensuring patient safety. By implementing supportive policies and fostering a just culture, healthcare systems can better manage the repercussions of AEs and support the wellbeing of healthcare professionals.

Do Spaniards know their rights as patients?

BACKGROUND: In 2002, Spain introduced new legislation regulating the rights of patients. Spaniards have thus seen an increase in their capacity for decision-making, bringing them into line with many other countries. However, the law changes do not mean to be acquainted with the new legislation and therefore, putting it into practice. OBJECTIVE: To analyse whether the rules governing patients' rights in Spain are sufficiently well known among patients and to identify the profile of those patients most aware of their rights. DESIGN: Cross-sectional quota-sampled survey study. A total of 790 patients discharged from hospitals or attended in primary care took a telephone survey, 773 replayed. RESULTS: Twenty per cent had some knowledge of the rules governing patients' rights. Respondent characteristics that were associated with better knowledge of basic rights included: age of medical responsibility (P < 0.001), cases in which a doctor may inform family members (P < 0.001), whether or not a patient can refuse treatment (P < 0.001) and what is constituted by advance directives (P < 0.001). Patients who opt for a more active role in consultations with medical professionals show greater knowledge of their rights (P < 0.01). Age was related to greater ignorance of these rights (P < 0.01). CONCLUSIONS: Patients' knowledge of their rights is quite limited, making it difficult for them to assert those rights in specific medical encounters. The youngest patients, the most demanding, and those who prefer to have the last word in decisions are those with the best knowledge of their rights as patients.

Why an Open Disclosure Procedure Is and Is not Followed After an Avoidable Adverse Event.

OBJECTIVE: The aim of the study was to analyze the relationships between factors that contribute to healthcare professionals informing and apologizing to a patient after an avoidable adverse event (AAE). METHODS: A secondary study based on the analysis of data collected in a cross-sectional study conducted in 2014 in Spain was performed. Health professionals from hospitals and primary care completed an online survey. RESULTS: The responses from 1087 front-line healthcare professionals were analyzed. The willingness of the professionals to fully disclose an AAE was greater among those who were backed by their institution (odds ratio [OR] = 72.6, 95% confidence interval [CI] = 37.5-140.3) and who had experience with that type of communication (OR = 2.4, 95% CI = 1.3-4.5). An apology for the patient was more likely when there was institutional support (OR = 31.3, 95% CI = 14.4-68.2), the professional was not aware of lawsuits (OR = 2.7, 95% CI = 1.2-6.1), and attributed most AAE to human error (OR = 2.2, 95% CI = 1.1-4.2). The fear of lawsuits was determined by the lack of support from the center in disclosing AAE (OR = 5.5, 95% CI = 2.8-10.6) and the belief that being open would result in negative consequences (OR = 2.0, 95% CI = 1.1-3.6). CONCLUSIONS: The culture of safety, the experience of blame, and the expectations about the outcome from communicating an AAE to patients affect the frequency of open disclosure. Nurses are more willing than physicians to participate in open disclosure. Health care organizations must act to establish a framework of legal certainty for professionals.

HPV oral and oropharynx infection dynamics in young population.

The incidence of human papillomavirus (HPV)-associated cancers, especially those from the head and neck region, has increased. The relatively early age of presentation of HPV-positive head and neck cancer (HNC) indicates that viral infection might be acquired early in life. Persistent HPV infection has been recognized as the main risk factor for cancer development, but most studies have focused on evaluating HPV persistence in the genital region. Thus, in this work, we aimed to evaluate the prevalence of HPV in oral cavity and oropharynx in a young population, as well as the possible persistence of the infection after 12 months. Our results indicate that almost half (46.8%) of the analyzed population harbors an HPV infection either in the oral cavity or in the oropharynx. Furthermore, after 1 year of initial identification, half of them eliminated the infection, and only one person (5.26%) exhibited persistence. Interestingly, 50% of the individuals who successfully eliminated the infection acquired a new viral type, indicating that even when the primary infection is effectively eliminated by the immune system, there is a dynamic circulation of HR-HPV types that produce reinfection. This dynamic HPV infection among young individuals could influence the future establishment of cancer in some proportion of the cases.

[Toward new approaches to quality. The patient as coprotagonist. 2008 SESPAS Report]. / Hacia nuevos planteamientos de calidad. El paciente como coprotagonista. Informe SESPAS 2008.

In recent decades, the doctor-patient relationship has been decisively transformed, reflecting social developments in health care and the rise of individual rights in our society. This article briefly reviews how this change has been reflected in the legal and social framework, how it affects the doctor-patient relationship, how health services should adapt to this new reality, which changes are predictable, or desirable, and how health services are currently responding. The model of healthcare should adjust to the new role played by patients, requiring quality control of the information accessed - available in different formats and from distinct sources - and new attitudes and skills of health professionals and patients. The development of a homogeneous information system throughout the Spanish national health service is required. This information system should address a minimum number of key indicators and outcomes. The dissemination and analysis of these indicators and outcomes is a pressing need, not only as a comparison tool, but to identify and disseminate good practices.

Early-life socioeconomic status and malocclusion in adolescents and young adults in Uruguay.

This study aims to estimate orthodontic treatment need among 15-24 year-old individuals in Montevideo, Uruguay, and the association of occlusal traits with demographic, clinical and socioeconomic factors, considering a life course approach. A cross-sectional study using data from the First National Oral Health Survey in Uruguay was conducted. A two-stage cluster procedure was used to select a sample of 278 individuals in Montevideo. Household interviews and oral examinations were performed by six dentists. Dental Aesthetic (DAI) and Decayed Missing and Filled Teeth Indices (DMFT) were used to assess orthodontic treatment need and dental caries, respectively. Early life and current socioeconomic factors were obtained from the interview. Ordinal logistic regression was used to model the DAI index. Prevalence of definite malocclusion was 20.6%, followed by severe (8.2%) and very severe (7.6%). In the adjusted analysis, individuals with untreated dental caries (OR = 1.11; 95%CI: 1.03-1.20) and those who reported a lower socioeconomic level at 6 years of age (OR = 5.52; 95%CI: 1.06-28.62) had a higher chance of being a worse case of malocclusion. Current socioeconomic position was not associated with orthodontic treatment need. Individuals aged 22-24 years (OR = 1.59; 95%CI: 1.05-2.41) had a lower chance than those aged 14-17. This study shows that orthodontic treatment need is relatively high in Uruguayan adolescents and young adults. There is a potential relationship between early life socioeconomic status and the occurrence of malocclusion in adolescents and young adults under a life course approach.

[What are hospitals and primary care doing to mitigate the social impact of serious adverse events]. / Qué hacen los hospitales y la atención primaria para mitigar el impacto social de los eventos adversos graves.

OBJECTIVE: To explore what hospitals and primary care (PC) are doing to reduce the negative social impact of a serious adverse event (AE). METHODS: We surveyed 195 hospital (n=113) and PC (n=82) managers from eight autonomous communities to explore the level of implementation of five interventions recommended after an AE to protect the reputation of healthcare institutions. RESULTS: Most institutions (70, 45.2% PC, and 85, 54.8% hospitals) did not have a crisis plan to protect their reputation after an AE. Internal (p=0.0001) and external (p=0.012) communications were addressed better in PC than in hospitals. Very few institutions had defined the managers' role in case of an AE (10.7% hospitals versus 6.25% PC). CONCLUSION: A majority of healthcare institutions have not planned crisis intervention after an AE with severe consequences nor have they defined plans to recover citizens' trust after an AE.