Perception Of Adverse Events Research Articles

Coping trajectories of intensive care nurses as second victims: A grounded theory

A qualitative study that provides evidence of the institutional support required by intensive care unit (ICU) nurses as second victims of adverse events (AEs). BackgroundThe phenomenon of second victims of AE in healthcare professionals can seriously impact professional confidence and contribute to the ongoing occurrence of AEs in hospitals. ObjectivesThe objective of this study was to describe the coping trajectories of second victims among nurses working in ICUs in public hospitals in Chile. MethodsConducting qualitative research through the grounded theory method, this study focused on high-complexity hospitals in Chile, using theoretical sampling. The participants consisted of 11 nurses working in ICUs. Techniques used included in-depth interviews conducted between March and May 2023, as well as a focus group interview. Analysis, following the grounded theory approach proposed by Strauss and Corbin, involved constant comparison of data. Open, axial, and selective coding were applied until theoretical data saturation was achieved. The study adhered to reliability and authenticity criteria, incorporating a reflexive process throughout the research. Ethical approval was obtained from the ethics committee, and the study adhered to the consolidated criteria for reporting qualitative research. ResultsFrom the interviews, 29 codes were identified, forming six categories: perception of support when facing an AE, perception of helplessness when facing an AE, initiators of AE, responses when facing an AE, professional responsibility, and perception of AE. The perception of support when facing an AE emerged as the main category, determining whether the outcome was stagnation or overcoming of the phenomenon after the AE. ConclusionsFor the coping process of ICU nurses following an AE, the most crucial factor is the support from colleagues and supervisors.

Nurses' Risk Perception of Adverse Events and Its Influencing Factors: A Cross-Sectional Study.

To investigate clinical nurses' perception of adverse event risk and to analyze its influencing factors. A proportional stratified random sampling method was applied to recruit nurses from a hospital in Shiyan City, Hubei Province, China. The Nursing Adverse Event Risk Perception Scale, Organizational Support Questionnaire, Nurse Manager Leadership Behavior Questionnaire, Nursing Safety Behavior Questionnaire, and Burnout scale was used to investigate 1084 nurses. Univariate analysis, Pearson correlation analysis, and multiple linear regression analysis were used to analyze the influencing factors. The scores of the Nurses' Risk Perception of Adverse Nursing Event Scale, Organizational Support Questionnaire, Nurse Manager Leadership Behavior Questionnaire, Nursing Safety Behavior Questionnaire, and Burnout Scale were 14.98 ± 5.39, 52.57 ± 10.00, 88.98 ± 21.08, 56.42 ± 5.03, 30.90 ± 21.49, respectively. According to the correlation analysis, nurses' perception of adverse nursing events was positively correlated with the sense of organizational support (r = .457, P < .01), head nurses' leadership behavior (r = .348, P < .01), and nurse safety behavior (r = .457, P < .01), and negatively correlated with the level of burnout (r = -.384, P < .01). According to the Regression analysis, nurses' departments (β = .226, P < .001), daily working hours (β = 1.122, P < .001), adverse events experience (β = -1.505, P < .001), organizational support (β = .105, P < .001), head nurses' leadership behavior (β = .072, P < .001), and burnout (β = -.052, P < .001) held an influence on nurses' risk perception of adverse nursing event. These factors explained 42.5% of the total variation. Nurses' risk perception of adverse nursing events needs to be improved. Nursing managers need to strengthen organizational support for nurses, change the leadership behavior of nurse managers, reduce nurses' burnout, improve nurses' risk perception of adverse nursing events, prevent adverse events, and ensure patient safety.

Self-reported efficacy and safety of infliximab and adalimumab biosimilars after non-medical switch in patients with inflammatory bowel disease: results of a multicenter survey

ABSTRACT Background Few data are available on subjective disease control and perception of adverse events (AEs) during switching from original anti-TNF agents to biosimilars. Research design and methods Hungarian patients with inflammatory bowel disease were interviewed after a mandatory non-medical switch from an infliximab (IFX) originator to a biosimilar GP1111 or from an adalimumab (ADA) originator to a biosimilar GP2017. Drug choice was based on patient’s and physician’s decision. Subjective efficacy was measured using a 10-point scale, and AEs were assessed. Difference in efficacy before and after the switch was compared within and between the drugs. Results Seventy-three ADA and 106 IFX switching patients were interviewed. Subjective efficacy of IFX biosimilar was rated lower compared to IFX originator (8.72 ± 1.68 vs. 7.77 ± 2.34; p = 0.001). The ADA biosimilar was rated higher than its originator (9.02 ± 1.61 vs. 8.42 ± 1.93; p = 0.017). Patients receiving ADA biosimilar were more satisfied with the new treatment compared to IFX (p = 0.032). The incidence of new AEs was 85% in the ADA and 55% in the IFX group (1.79 vs. 0.93 AEs per patient, respectively, p < 0.001). Conclusion Subjective efficacy of switching to a biosimilar was proven in case of ADA, while reduced efficacy was experienced with IFX biosimilar. Perception of AEs was high and varied between biosimilars.

Notificação de eventos adversos pelos enfermeiros para maior segurança em enfermagem pediátrica

Introduction: Adverse Events remain a current challenge in healthcare, being defined as incidents that resulted in unnecessary harm to the patient. The choice of the pediatric population the object of this study is based on certain characteristics making it the most susceptible to Adverse Events. Reporting them is a key action of the strategy to reduce its occurrence, while Nurses remain essential elements to the process. The ultimate goal is Patient Safety, the reduction of the risk of unnecessary healthcare-related harm to an acceptable minimum. Objective: Describe Nurses’ Adherence to Adverse Events Reporting and the Factors associated with it in a Pediatric setting. Methods: A Cross-sectional Observational Study is presented, based on a survey conducted in the Pediatrics Department of a hospital. The study included 88 categorical variables, related to respondents' perception of Adverse Events, Errors, Incidents and Patient Safety. Univariable, bivariable, and correlation analysis were used. Results: A total of 69% of nurses did not report any Adverse Event in 2019. The events more frequently reported were those with the most serious consequences for the patients (54%) and those related to organizational dysfunctions of the institution (74-90%). Factors which facilitate the occurrence of Adverse Events include the lack of human resources (19%), communication failures and overtime (17%), and the main barrier to Reporting is forgetting to do so when there is a greater workload (63%). Conclusion: A low percentage of reporting related to nurses’ adherence to adverse events was found in this investigation. This highlighted the need to invest in the institution’s Safety Culture by enhancing healthcare professionals’ awareness of the importance of their role in improving Patient Safety. Integrating notification into the daily practice of professionals, using continuous awareness enhancement, strengthening multidisciplinary teams, investing in communication and down grading workload is essential and can facilitate improvement.

P797 Self-reported efficacy and safety of infliximab and adalimumab biosimilars after non-medical switch in patients with Inflammatory Bowel Disease: Results of a multicenter survey

Abstract Background Several studies have proven similarity in terms of efficacy and safety between infliximab (IFX) or adalimumab (ADA) biosimilars and their corresponding originators. However, there is still a paucity of data on the impact of switching from an originator to a biosimilar on patients’ subjective disease control in clinical practice. In Hungary, a mandatory non-medical switch program regarding anti-TNFs was launched in 2021. We aimed to assess symptom control and perception of adverse events following non-medical switch in patients with inflammatory bowel disease (IBD). Methods In this cross-sectional, questionnaire-based study, Hungarian patients with IBD who switched from infliximab originator to biosimilar GP1111 or from adalimumab originator to biosimilar GP2017 after receiving at least one dose of biosimilar were interviewed. The subjective efficacy was measured using a 10-point interval rating scale, and adverse events were assessed. The difference in efficacy before and after the switch was calculated and compared within and between the two drugs. All statistical analysis was performed using R Statistical Software. Results A total of 179 patients were interviewed (median age 41 years, interquartile range 32 to 47; 135 and 44 patients with Crohn’s disease and ulcerative colitis, respectively). There were 73 ADA and 106 IFX switches in our cohort. The subjective efficacy of IFX biosimilar was rated lower compared to IFX reference product (8.72±1.68 vs. 7.77±2.34; p=0.001). The ADA biosimilar was rated higher than their reference product (9.02±1.61 vs. 8.42±1.93; p=0.017). Comparing the satisfaction of non-medical switch between biosimilar groups, patients receiving ADA were more satisfied with the new treatment as patients in the IFX group (p=0.032). The incidence of new perceived adverse events was 85 % in the ADA and 55 % in the IFX group (p&amp;lt;0.001). 66 % of patients on ADA treatment reported pain at the subcutaneous injection site. Conclusion Our study confirmed the efficacy of the switch to a biosimilar in the case of ADA, while reduced efficacy was experienced with IFX biosimilar. Based on the different adverse event profiles of biosimilars, the importance of switching the product for medical reasons should be emphasized.

Correlation of Structural and Behavioral Factors to Dropout Status of Childhood Immunization

Immunization dropout (DO) occurs when a child does not receive follow-up immunization according to the set schedule. High dropout status has potential increasing the risk of contracting dangerous diseases because the body immunity is not optimal. Resistance, hesitate and distrust of vaccines lead to delays and refusal of immunization. The study aims to analyze the incidence of immunization dropout from structural and behavioral dimensions. This is a quantitative study with a cross-sectional approach. The population was all children aged 12-23 months in Central Java province with totally sample of 685 people. Data were collected through interviews using structured questionnaire instruments and observations using the MCH Book. The dropout rate for DPT/HB/HiB_1 to DPT/HB/HiB_3 immunization was 6.2%, and to Meales/Rubella was 10.4%. A total of 14.4% of children have a dropout immunization status. For structural dimension, there is a correlation between information sources and family income with dropout status. For behavioral dimension, variables of knowledge, perception of adverse events and perception of booster correlated with immunization dropout status. The involvement of all stakeholders is needed to provide correct information about vaccines and immunization, as well as the use of attractive communication media. Responsive and adequate surveillance and anticipation of adverse immunization reports should be strengthened.

The impact of patient-reported outcomes in cancer patients in Croatia.

e18659 Background: Perception of symptoms is essential for optimal cancer care and improving the quality of life but an inappropriate interpretation may lead to treatment outcomes failure or may leave the patients undertreated. This variation in the perception of adverse events (AEs) can lead to wrong assumptions and potentially unnecessary hospitalizations (H) or emergency room visits (ERV). Methods: Patients considered for inclusion were 18 years of age or older receiving systemic therapy and were able to read and understand questionnaire via tablet computers. All patients had a verified diagnosis of malignant disease of breast (31%), lung (17%), colorectal (16%), hematological (8%) or other site cancers (28%). Patients were asked on the same day as physician assessment, to complete 10 PRO-CTCAE symptoms (including fatigue, pain, nausea, vomiting, diarrhea, dysgeusia, appetite, sleep disturbance, fever, and alopecia). Participants remained on study until discontinuation of cancer treatment, withdrawal, or death. Informed consent was obtained from all patients and the study was approved by the institutional review board of the General Hospital Pula, Croatia. Concordance of symptoms reporting between patients and health care providers at the individual level was compared, and intraclass correlation coefficients were computed by a two way mixed effect model and an absolute agreement definition. Univariate and multivariate COX proportional hazard models adjusted for covariates including age, gender, cancer type and performance status were constructed for unplanned H and ERV. Results: The median age of 308 included patients in this trial was 62 years. Cohen's coefficient of agreement that corrects for chance for AEs gr. 1-5 and AEs gr. 3-4 was 0.115 (95%, CI, 0.15 to 0.02), indicating only slight agreement and 0.320 (95%, CI, 0.428 to 0.448) indicating fair agreement, respectively. Physicians underestimated symptoms at the group level (p &lt; 0.013) for all symptoms. The highest level of agreement was found for pain but fatigue and alopecia were most underestimated. The median times of follow-up were 13 months, and 8,1 % of patients had H or ERV. Female patients had worse PRO scores, with higher levels of pain, fatigue, and alopecia across disease groups. In multivariate analysis, patient symptoms was not predictive, but we noticed trend for higher patient reports of pain (p = 0.05) for unnecessary H or ERV. Conclusions: The failure of the physician to identify a substantial number and severity of symptoms identified by the PRO instrument is not surprising considering the published experience in clinical trials. To our knowledge, this is the first such analysis aimed specifically at examining the reliability of physician identification of AEs in a real world practice in Croatia. The incorporation of PRO measures into routine practice might help to avoid unnecessary hospitalizations and emergency room visits. Clinical trial information: 2019-000855-15.

Spanish Version of the Scale "Eventos Adversos Associados às Práticas de Enfermagem" (EAAPE): Validation in Nursing Students.

Healthcare carried out by different health professionals, including nurses, implies the possible appearance of adverse events that affect the safety of the patient and may cause damage to the patient. In clinical practice, it is necessary to have measurement instruments that allow for the evaluation of the presence of these types of events in order to prevent them. This study aims to validate the “Eventos adversos associados às práticas de enfermagem” (EAAPE) scale in Spanish and evaluate its reliability. The validation was carried out through a cross-sectional study with a sample of 337 nursing students from the University of Valencia recruited during the 2018–19 academic year. An exploratory factor analysis was carried out using principal components and varimax rotation. The factor analysis extracted two factors that explained 32.10% of the total variance. Factor 1 explains 22.19% and refers to the “adverse results” of clinical practice (29 items), and factor 2 explains 9.62% and refers to “preventive practices” (24 items). Both factors presented high reliability (Cronbach’s alpha 0.902 and 0.905, respectively). The Spanish version of the EAAPE is valid and reliable for measuring the perception of adverse events associated with nursing practice and the presence of prevention measures.

The relationships between paediatric nurses' social support, job satisfaction and patient adverse events.

AimsTo explore the relationships of family, co‐worker and manager support with paediatric nurses' satisfaction and their perception of adverse events. Furthermore, this study aimed to assess the job satisfaction, social support and the perceived patient adverse events.DesignThis study used a cross‐sectional correlational design.MethodsA convenient sample of 225 paediatric nurses was selected from nine hospitals in Jordan. Both the Pearson correlations and multiple regression tests were used in the analysis. The study was prepared and is reported according to the STROBE checklist.ResultsSignificant and positive correlations were found between paediatric nurses' job satisfaction and the social support they receive. Significant negative correlations were also found between adverse events and both family and manager support. The multiple regression results showed that manager support is a significant negative predictor of both pressure ulcers and patient falls, and family support significantly predicted paediatric nurses' job satisfaction.

Applicability of the Disruptions in Surgery Index in the Cardiovascular Management Scenarios - A Marker for Developing Functionally Efficient Teams.

Introduction To support the development of practices and guidelines that might help to reduce adverse events related to human factors, we aimed to study the response and perception by members of a cardiovascular surgery team of various error-driven or adverse features that might arise in the operating room (OR).Methods A previously validated Disruptions in Surgery Index (DiSI) questionnaire was completed by individuals working together in a cardiovascular surgical unit. Results were submitted to reliability analysis by calculating the Cronbach’s alpha coefficient. Non-parametric Kruskal-Wallis test and Dunn’s post-test were performed to estimate differences in perceptions of adverse events or outcomes between the groups (surgeons, nurses, anesthesiologists, and technicians). P<0.05 was considered statistically significant.Results Cronbach’s alpha reliability coefficients showed consistency within the recommended range for all disruption types assessed in DiSI: an individual’s skill (0.85), OR environment (0.88), communication (0.81), situational awareness (0.92), patient-related disruption (0.89), team cohesion (0.83), and organizational disruption (0.83). Nurses (27.4%) demonstrated significantly higher perception of disruptions than surgeons (25.4%), anesthetists (23.3%), and technicians (23.0%) (P=0.005). Study participants were more observant of their colleagues’ disruptive behaviors than their own (P=0.0001).Conclusion Our results revealed that there is a tendency among participants to hold a positive self-perception position. DiSI appears to be a reliable and useful tool to assess surgical disruptions in cardiovascular OR teams, identifying negative features that might imperil teamwork and safety in the OR. And human factors training interventions are available to develop team skills and improve safety and efficiency in the cardiovascular OR.

Factors associated with the occurrence of adverse events to antiretroviral therapy in adults and elderly living with HIV

Objectives: This study identifies the factors associated with the occurrence of adverse events in adults and elderly on antiretroviral therapy. Methods: This is a cross-sectional study carried out with adults and elderly patients, attended by the Specialized Assistance Service between September 2016 and August 2017. Adverse events were measured through self-reports collected in interviews, information collected in medical records, and changes identified in laboratory tests, with the degree of causality being assessed using the Naranjo Algorithm. Univariate analysis, with results expressed as odds ratio (OR) and their respective confidence intervals (CI 95%), was performed to estimate the association between sociodemographic, pharmacotherapeutic, and clinical characteristics (explanatory variables) with the occurrence of four or more adverse events to antiretroviral therapy (response variable). For multivariate analysis, multiple logistic regression was considered in order to verify the permanence or absence of associations previously found in the univariate analysis. Results: Prevalence of adverse events to antiretroviral therapy was 92.6%, with the median of adverse events being four (IQR 25%: 2 ; IQR 75%: 5) and two (IQR 25%: 2 ; IQR 75%: 4), respectively, among adults and elderly (p <0.05). Additionally, 340 adverse events were identified, among which nightmares (15.0%) and vertigo (13.5%) were the most frequent. Most of the adverse events identified were classified as possible (96.2% / n = 327). In the initial univariate analysis, factors such receipt of guidance on adverse events and age were associated with a higher occurrence of adverse events to antiretroviral therapy. Contrary to expectations, the elderly were considered less susceptible to have adverse events when compared to adults (OR = 0.363; CI 95% = 0.164-0.801). However, the final multivariate analysis model revealed “receipt of guidance on adverse events” as the only variable significantly associated with the presence of four or more adverse events to antiretroviral therapy (OR = 4.183 ; CI 95% = 1.775-9.855). Conclusions: Results suggest difference in perception of adverse events between patients who received and those who did not receive guidance in this regard, which indicates the importance of health professionals to provide specific information to their patients regarding adverse events to antiretroviral therapy. Thus the patient can understand the effects generated by the treatment and inform these professionals for the notification of adverse events, in order to improve pharmacovigilance actions and promote patient safety.

Perceived occurrence of an adverse event affects patient-reported outcomes after total hip replacement

BackgroundDislocation, periprosthetic fracture and infection are serious complications of total hip replacement (THR) and which negatively impact on patients’ outcomes including satisfaction, quality of life, mental health and function. The accuracy with which patients report adverse events (AEs) after surgery varies. The impact of patient self-reporting of AEs on patient-reported outcome measures (PROMs) after THR is yet to be investigated. Our aim was to determine the effect of confirmed and perceived AEs on PROMs after primary THR.MethodsA prospective single-centre cohort study of patients undergoing primary THR, with one-year follow-up, was performed. Participants completed forms pre-operatively and 3, 6, 9 and 12 months post-operatively, including Work Productivity and Activity Impairment (WPAI), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), EuroQol-5D-3 L (EQ5D), Self-Administered Patient Satisfaction (SAPS) and AE reporting questionnaires. Results were reported in three groups: No AE, reported but not confirmed AE and confirmed AE. A generalised linear model was used to compare among groups using robust standard errors (SE).ResultsForty-one AEs were reported in a cohort of 417 patients (234 females), with 30 AEs reported by 3 months. Eleven (27 reported) infections, two (six reported) periprosthetic fractures and two (eight reported) dislocations were confirmed. Those in the no AE group reported significantly better outcomes that the reported AE group as measured by WOMAC Co-Eff 14.27 (p = 0.01), EQ5D − 0.128 (p = 0.02) and SAPS − 9.926 (p = 0.036) and the combined reported and confirmed AE groups as measured by WOMAC Co-Eff 13.72 (p = 0.002), EQ5D − 0.129 (p = 0.036) and SAPS − 11.512 (p = 0.004). No significant differences were seen in WPAI among groups.ConclusionsPatients who report AEs have worse outcomes than those who do not, regardless of whether the AEs can be confirmed by standard medical record review methods. The observed negative trends suggest that patient perception of AEs may influence patient outcome in a similar way to those with confirmed AEs.

CN87 - Agreement between breast cancer patients and oncologists on the severity of patients’ symptoms and functions during a one-year follow-up after treatment

BackgroundDiscrepancies in perception of adverse events between patients and physicians may influence the follow up services of cancer patients. With patient ratings as the gold standard, physicians more often underrate the symptom severities. In breast cancer (BC) populations, studies of interrater agreement are deficient. We evaluated the agreement between BC patients and their oncologists on the rating of symptoms and functioning in a clinical follow-up study at Trondheim University Hospital. MethodsAt five clinical controls during the first year after primary treatment BC patients (n=250) and their oncologist (n=14) reported symptoms and functions by completing the EORTC QLQ-C30/QLQ-BR23 and CTCAE questionnaires, respectively. Fatigue, hot flushes, breast pain, arm pain, emotional and physical functioning were comparable and scored on a four point Likert scale: not at all, mild, moderate and severe. The degree of agreement was evaluated by the Kappa(κ) coefficient. The McNemar-Bowker Test was used to test for association between raters and rating outcome. ResultsFour symptoms and two functions were assessed five times. Of 35 assessments, poor agreement (κ<0.20) was identified on 24 assessments, fair agreement (0.21< κ>0.40) on 10 assessments and moderate agreement (κ=0.41) on one assessment (physical function). Overall, the oncologists rated the severity of all symptoms and the functions significantly lower than the patients (p<0.01). The agreement decreased with increasing symptom severity and function impairment. ConclusionsDiscrepancies in reporting symptom severity between patients and oncologists might be due to high subjectiveness of symptoms and different understanding of the construct being measured. Personal characteristics of both raters, the context of the clinical controls and the nature of the relationship between patients and physicians may also contribute to discrepancies. Our results emphasize the importance of collecting patient reported data during follow up after BC treatment as it may improve diagnosis and treatment of adverse effects. Legal entity responsible for the studyNTNU, Department of Circulation and Medical Imaging, the authors. FundingNorwegian University of Science and Technology. DisclosureAll authors have declared no conflicts of interest.

Knowledge and Perceptions of Adverse Events Following Immunization among Healthcare Professionals in Africa: A Case Study from Ghana.

The spontaneous reporting of suspected adverse events following immunization (AEFI) by healthcare professionals (HCPs) is vital in monitoring post-licensure vaccine safety. The main objective of this study was to assess the knowledge and perceptions of AEFIs among healthcare professionals (HCPs) in Africa, using the situation in Ghana as a case study. The study was of a cross-sectional quantitative design, and was carried out from 1 July 2017 to 31 December 2017 with doctors, pharmacists, and nurses as the study participants. A 28-item paper-based questionnaire, delivered by hand to study participants, was the data collection tool in the study. The study was conducted in 4 hospitals after ethical approval was granted. The desired sample size was 686; however, 453 consented to partake in the study. Data were analyzed using SPSS (software version 22, IBM, Armonk, NY, USA), and chi-square and binary logistic regression tests were used for tests of association between HCPs’ characteristics and their knowledge and perceptions. Detailed knowledge of AEFIs was ascertained with a set of 9 questions, with 8 or 9 correctly answered questions signifying high knowledge, 5 to 7 correctly answered questions signifying moderate knowledge, and below 5 correctly answered questions signifying low knowledge. A set of 10 questions also ascertained HCPs’ positive and negative perceptions of AEFI. Results revealed that knowledge of AEFIs was high in 49 (10.8%) participants, moderate in 213 (47.0%) participants, and low in 191 (42.2%) participants. There was no statistically significant correlation between AEFI knowledge and professions. The highest negative perception was the lack of desire to learn more about how to diagnose, report, investigate, and manage AEFI, whereas the lowest was the lack of belief that surveillance improves public trust in immunization programs. There was a general awareness of AEFIs among HCPs in this study. However, negative perceptions and the lack of highly knowledgeable HCPs regarding AEFIs were possible setbacks to AEFI diagnosis, management, prevention, and reporting. More training and sensitization of HCPs on AEFIs and vaccine safety will be beneficial in improving the situation. Future research should focus on assessing the training materials and methodology used in informing HCPs about AEFIs and vaccine safety.

A qualitative evaluation of healthcare professionals’ perceptions of adverse events focusing on communication and teamwork in maternity care

The aim of this study was to explore healthcare professionals' (HCPs) perceptions of adverse events (AE) during childbirth with focus on communication and teamwork. Inadequate communication, a poor teamwork climate and insufficient team training are harmful to women. Reviews of reported AE can be used to develop a safety culture based on preparedness for preventing AE and strengthening patient safety (PS). Action research principles were used to facilitate the implementation and evaluation of this study. An interprofessional team of HCPs comprising obstetricians, registered midwives and assistant nurses employed at a labour ward agreed to take part. Data were collected from multistage focus group interviews (March 2016-June 2016) and analysed by means of interpretative thematic analysis. Two analytical themes based on five sub-themes emerged; promoting interprofessional teamwork and building capabilities by involving HCPs and elucidating relevant strategies. The findings reveal the importance of facilitating relationships based on trust and respectful communication to ensure a safe environment and provide safe maternity care. There is a need for formal and informal support for quality interprofessional teamwork. Research on PS may reduce AE related to miscommunication and poor teamwork. We recommend different forms of communication and teamwork training in interprofessional teams to increase the ability to provide feedback. Accumulated research is required for the evaluation of evidence-based models in the PS context.

Is the efficacy of antidepressants in panic disorder mediated by adverse events? A mediational analysis.

It has been hypothesised that the perception of adverse events in placebo-controlled antidepressant clinical trials may induce patients to conclude that they have been randomized to the active arm of the trial, leading to the breaking of blind. This may enhance the expectancies for improvement and the therapeutic response. The main objective of this study is to test the hypothesis that the efficacy of antidepressants in panic disorder is mediated by the perception of adverse events. The present analysis is based on a systematic review of published and unpublished randomised trials comparing antidepressants with placebo for panic disorder. The Baron and Kenny approach was applied to investigate the mediational role of adverse events in the relationship between antidepressants treatment and efficacy. Fourteen placebo-controlled antidepressants trials were included in the analysis. We found that: (a) antidepressants treatment was significantly associated with better treatment response (ß = 0.127, 95% CI 0.04 to 0.21, p = 0.003); (b) antidepressants treatment was not associated with adverse events (ß = 0.094, 95% CI -0.05 to 0.24, p = 0.221); (c) adverse events were negatively associated with treatment response (ß = 0.035, 95% CI -0.06 to -0.05, p = 0.022). Finally, after adjustment for adverse events, the relationship between antidepressants treatment and treatment response remained statistically significant (ß = 0.122, 95% CI 0.01 to 0.23, p = 0.039). These findings do not support the hypothesis that the perception of adverse events in placebo-controlled antidepressant clinical trials may lead to the breaking of blind and to an artificial inflation of the efficacy measures. Based on these results, we argue that the moderate therapeutic effect of antidepressants in individuals with panic disorder is not an artefact, therefore reflecting a genuine effect that doctors can expect to replicate under real-world conditions.

Mothers? Knowledge and Perception of Adverse Events Following Immunization in Enugu, South-East, Nigeria

Background: Active immunization has been able to turn many childhood diseases into distant memories in industrialized countries. It has been found to be one of the most cost-effective public health interventions. However, immunization coverage has continued to falter in Nigeria due to missed opportunities, non availability of services and probably fears of adverse events that follow immunization. We therefore set out to determine mothers’ knowledge and perception of adverse events following immunization (AEFI) in Enugu. Methods: A structured interviewer administered questionnaire was administered to 235 mothers with at least one child < 5 years attending children outpatient clinics. Result: Most mothers (50.1%) had tertiary education, 39.6% and 9.4% had secondary and primary education respectively while 0.9% had no formal education. Five did not know why children were immunized, 188 knew it was to prevent major killer diseases, 33 believed it was to prevent all diseases while 9 believed it was to treat diseases. The knowledge of reason for immunization was significantly associated with maternal educational (p=0.000). Most (89.8%) also knew that the major content of vaccines were chemicals/substances that could help prevent killer diseases. While 1.3% believed vaccines contained harmful materials, 8.9% had no knowledge about the content of vaccines. This was significantly associated with maternal education (p=0.001). Majority (34%) were unable to mention any adverse event, 31.6% mentioned only one adverse event. While, 23.8% mentioned two, 10.6% mentioned three or more AEFI. Eighty percent would continue if their children suffered adverse events, 6% would not continue, 13.6% were undecided and 0.4% did not respond. Conclusion: There is poor maternal knowledge about immunization and the adverse events that could follow immunization. Community participation, and sustained public awareness are needed to erode fears of AEFI.

Adverse events in hospitals: the patient's point of view

BackgroundThe publication of the report “To err is human: building a safer system” by the Institute of Medicine incited a profuse research addressing improvements in healthcare safety. However, there is...

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Discordance between the patient’s and surgeon’s perception of complications following hernia surgery

The study was undertaken in order to assess the degree of concordance between the patient's and surgeon's perceptions of adverse events after groin hernia surgery. 206 patients who underwent elective surgery for groin hernia at Samariterhemmet, Uppsala, Sweden in 2003 were invited to a follow-up visit after 3-6 weeks. At this visit the patient was instructed to answer a questionnaire including 12 questions concerning postoperative complications. A postoperative history was taken and a clinical examination performed by a surgeon who was not present at the operation and did not know the outcome of the questionnaire. All complications noted by the physician were recorded for corresponding questions in the questionnaire. 174 (84.5%) patients attended the follow up, 161 men and 13 women. A total of 190 complications were revealed by the questionnaire, 32 of which had caused the patient to seek help from the health-care system. There were 131 complications registered as a result of the follow-up clinical examinations and history. Kappa levels ranged from 0.11 for urinary complications to 0.56 for constipation. In general, the concordance was poor. These results emphasise the importance of providing detailed information about the usual postoperative course prior to the operation. Whereas the surgeon, from a professional point of view, has a better idea about what should be expected in the postoperative period and how any complications should be categorised, only the patient has a complete picture of the symptoms and adverse events. This makes it impossible to reach complete agreement between the patient's and surgeon's perceptions of complications, even under the most ideal circumstances.