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Background: Schizophrenia is mostly a chronic disorder whose symptoms include psychosis, negative symptoms and cognitive dysfunction. Poor adherence is common and related relapse can impair outcomes. Long-acting injectable antipsychotics (LAIs) may promote treatment adherence and decrease the likelihood of relapse and rehospitalization. Using LAIs in first-episode psychosis (FEP) and early-phase (EP) schizophrenia patients could benefit them, yet LAIs have traditionally been reserved for chronic patients. Methods: A three-step modified Delphi panel process was used to obtain expert consensus on using LAIs with FEP and EP schizophrenia patients. A literature review and input from a steering committee of five experts in psychiatry were used to develop statements about patient population, adverse event management, and functional recovery. Recruited Delphi process psychiatrists rated the extent of their agreement with the statements over three rounds (Round 1: paper survey, 1:1 interview; Rounds 2–3: email survey). Analysis rules determined whether a statement progressed to the next round and the level of agreement deemed consensus. Measures of central tendency (mode, mean) and variability (interquartile range) were reported back to help panelists assess their previous responses in the context of those of the overall group. Results: The Delphi panelists were 17 psychiatrists experienced in treating schizophrenia with LAIs, practicing in seven countries (France, Italy, US, Germany, Spain, Denmark, UK). Panelists were presented with 73 statements spanning three categories: patient population; medication dosage, management, and adverse events; and functional recovery domains and assessment. Fifty-five statements achieved ≥ 80% agreement (considered consensus). Statements with low agreement (40-79%) or very low agreement (< 39%) concerned initiating dosage in FEP and EP patients, and managing loss of efficacy and breakthrough episodes, reflecting current evidence gaps. The panel emphasized benefits of LAIs in FEP and EP patients, with consensus that LAIs can decrease the risk of relapse, rehospitalization, and functional dysfunction. The panel supported links between these benefits and multidimensional longer-term functional recovery beyond symptomatic remission. Conclusions: Findings from this Delphi panel support the use of LAIs in FEP and EP schizophrenia patients regardless of disease severity, number of relapses, or social support status. Gaps in clinician knowledge make generating evidence on using LAIs in FEP and EP patients critical. [ABSTRACT FROM AUTHOR]

Background: Vaccine hesitancy has been a growing challenge for public health in recent decades. Among factors contributing to vaccine hesitancy, concerns regarding vaccine safety and Adverse Events (AEs) play the leading role. Moreover, cognitive biases are critical in connecting such concerns to vaccine hesitancy behaviors, but their role has not been comprehensively studied. In this study, our first objective is to address concerns regarding vaccine AEs to increase vaccine acceptance. Our second objective is to identify the potential cognitive biases connecting vaccine hesitancy concerns to vaccine-hesitant behaviors and identify the mechanism they get triggered in the vaccine decision-making process.Methods: First, to mitigate concerns regarding AEs, we quantitatively analyzed the U.S. Vaccine Adverse Event Reporting System (VAERS) from 2011 to 2018 and provided evidence regarding the non-severity of the AEs that can be used as a communicable summary to increase vaccine acceptance. Second, we focused on the vaccination decision-making process. We reviewed cognitive biases and vaccine hesitancy literature to identify the most potential cognitive biases that affect vaccine hesitancy and categorized them adopting the Precaution Adoption Process Model (PAPM).Results: Our results show that the top frequent AEs are expected mild reactions like injection site erythema (4.29%), pyrexia (3.66%), and injection site swelling (3.21%). 94.5% of the reports are not serious and the average population-based serious reporting rate over the 8 years was 25.3 reports per 1 million population. We also identified 15 potential cognitive biases that might affect people's vaccination decision-making and nudge them toward vaccine hesitancy. We categorized these biases based on the factors that trigger them and discussed how they contribute to vaccine hesitancy.Conclusions: This paper provided an evidence-based communicable summary of VAERS. As the most trusted sources of vaccine information, health practitioners can use this summary to provide evidence-based vaccine information to vaccine decision-makers (patients/parents) and mitigate concerns over vaccine safety and AEs. In addition, we identified 15 potential cognitive biases that might affect the vaccination decision-making process and nudge people toward vaccine hesitancy. Any plan, intervention, and message to increase vaccination uptake should be modified to decrease the effect of these potential cognitive biases. [ABSTRACT FROM AUTHOR]

Background: The aims of this systematic review and meta-analysis are to examine the prevalence of adverse mental health outcomes, both short-term and long-term, among SARS patients, healthcare workers and the general public of SARS-affected regions, and to examine the protective and risk factors associated with these mental health outcomes.Methods: We conducted a systematic search of the literature using databases such as Medline, Pubmed, Embase, PsycInfo, Web of Science Core Collection, CNKI, the National Central Library Online Catalog and dissertation databases to identify studies in the English or Chinese language published between January 2003 to May 2020 which reported psychological distress and mental health morbidities among SARS patients, healthcare workers, and the general public in regions with major SARS outbreaks.Results: The literature search yielded 6984 titles. Screening resulted in 80 papers for the review, 35 of which were included in the meta-analysis. The prevalence of post-recovery probable or clinician-diagnosed anxiety disorder, depressive disorder, and post-traumatic stress disorder (PTSD) among SARS survivors were 19, 20 and 28%, respectively. The prevalence of these outcomes among studies conducted within and beyond 6 months post-discharge was not significantly different. Certain aspects of mental health-related quality of life measures among SARS survivors remained impaired beyond 6 months post-discharge. The prevalence of probable depressive disorder and PTSD among healthcare workers post-SARS were 12 and 11%, respectively. The general public had increased anxiety levels during SARS, but whether there was a clinically significant population-wide mental health impact remained inconclusive. Narrative synthesis revealed occupational exposure to SARS patients and perceived stigmatisation to be risk factors for adverse mental health outcomes among healthcare workers, although causality could not be determined due to the limitations of the studies.Conclusions: The chronicity of psychiatric morbidities among SARS survivors should alert us to the potential long-term mental health complications of covid-19 patients. Healthcare workers working in high-risk venues should be given adequate mental health support. Stigmatisation against patients and healthcare workers should be explored and addressed. The significant risk of bias and high degree of heterogeneity among included studies limited the certainty of the body of evidence of the review. [ABSTRACT FROM AUTHOR]

Background: Youth facing barriers created by social marginalization are at a greater risk of adverse health outcomes, lower educational and occupational attainment, and decreased overall quality of life as adults. The negative psychosocial and physiological consequences of significant barriers to positive development during youth may be mitigated by interventions promoting physical activity, psychosocial development, and healthy behaviours. Sport for Development programming is a possible opportunity for youth facing barriers to engage in activities that foster positive youth development, which may improve socioeconomic outcomes, quality of life and long-term health status in this population. This paper outlines the study protocol measuring impact of an urban Sport for Development facility on positive youth development in youth facing barriers.Methods/design: Participants aged 6-29 will be recruited from programs at an urban Sport for Development facility to a 2-year prospective longitudinal mixed-methods study. Participants will be stratified by age into three cohorts with age-specific outcomes. Age-specific positive youth development outcomes will be assessed quantitatively by self-report and pedometer at baseline and after 6 months, 1-year, and 2-years of program participation. Focus groups will provide data regarding youth experience and the impact of facility and program components on youth outcomes.Discussion: Our findings will inform best-practice and feasibility of a Sport for Development facility delivering programs in a socially and economically challenged urban setting in a high-income country.Trial Registration: ISRCTN67016999. Date of registration: October 22, 2019. [ABSTRACT FROM AUTHOR]

In this paper, we show how we have applied the Clinical Narrative Temporal Relation Ontology (CNTRO) and its associated temporal reasoning system (the CNTRO Timeline Library) to trend temporal information within medical device adverse event report narratives. 238 narratives documenting occurrences of late stent thrombosis adverse events from the Food and Drug Administration's (FDA) Manufacturing and User Facility Device Experience (MAUDE) database were annotated and evaluated using the CNTRO Timeline Library to identify, order, and calculate the duration of temporal events. The CNTRO Timeline Library had a 95% accuracy in correctly ordering events within the 238 narratives. 41 narratives included an event in which the duration was documented, and the CNTRO Timeline Library had an 80% accuracy in correctly determining these durations. 77 narratives included documentation of a duration between events, and the CNTRO Timeline Library had a 76% accuracy in determining these durations. This paper also includes an example of how this temporal output from the CNTRO ontology can be used to verify recommendations for length of drug administration, and proposes that these same tools could be applied to other medical device adverse event narratives in order to identify currently unknown temporal trends. [ABSTRACT FROM AUTHOR]

Background Several authors have developed and applied methods to routine data sets to identify the nature and rate of complications following interventional procedures. But, to date, there has been no systematic search for such methods. The objective of this article was to find, classify and appraise published methods, based on analysis of clinical codes, which used routine healthcare databases in a United Kingdom setting to identify complications resulting from interventional procedures. Methods A literature search strategy was developed to identify published studies that referred, in the title or abstract, to the name or acronym of a known routine healthcare database and to complications from procedures or devices. The following data sources were searched in February and March 2013: Cochrane Methods Register, Conference Proceedings Citation Index - Science, Econlit, EMBASE, Health Management Information Consortium, Health Technology Assessment database, MathSciNet, MEDLINE, MEDLINE in-process, OAIster, OpenGrey, Science Citation Index Expanded and ScienceDirect. Of the eligible papers, those which reported methods using clinical coding were classified and summarised in tabular form using the following headings: routine healthcare database; medical speciality; method for identifying complications; length of follow-up; method of recording comorbidity. The benefits and limitations of each approach were assessed. Results From 3688 papers identified from the literature search, 44 reported the use of clinical codes to identify complications, from which four distinct methods were identified: 1) searching the index admission for specified clinical codes, 2) searching a sequence of admissions for specified clinical codes, 3) searching for specified clinical codes for complications from procedures and devices within the International Classification of Diseases 10th revision (ICD- 10) coding scheme which is the methodology recommended by NHS Classification Service, and 4) conducting manual clinical review of diagnostic and procedure codes. Conclusions The four distinct methods identifying complication from codified data offer great potential in generating new evidence on the quality and safety of new procedures using routine data. However the most robust method, using the methodology recommended by the NHS Classification Service, was the least frequently used, highlighting that much valuable observational data is being ignored. [ABSTRACT FROM AUTHOR]

Background: To illustrate the 10-year risks of urinary adverse events (UAEs) among men diagnosed with prostate cancer and treated with different types of therapy, accounting for the competing risk of death.Methods: Prostate cancer is the second most common malignancy among adult males in the United States. Few studies have reported the long-term post-treatment risk of UAEs and those that have, have not appropriately accounted for competing deaths. This paper conducts an inverse probability of treatment (IPT) weighted competing risks analysis to estimate the effects of different prostate cancer treatments on the risk of UAE, using a matched-cohort of prostate cancer/non-cancer control patients from the Surveillance, Epidemiology and End Results (SEER) Medicare database.Results: Study dataset included men age 66 years or older that are 83% white and had a median follow-up time of 4.14 years. Patients that underwent combination radical prostatectomy and external beam radiotherapy experienced the highest risk of UAE (IPT-weighted competing risks: HR 3.65 with 95% CI (3.28, 4.07); 10-yr. cumulative incidence = 36.5%).Conclusions: Findings suggest that IPT-weighted competing risks analysis provides an accurate estimator of the cumulative incidence of UAE taking into account the competing deaths as well as measured confounding bias. [ABSTRACT FROM AUTHOR]

Background: Maternity intrapartum care research and clinical care more often focus on outcomes that minimise or prevent adverse health rather than on what constitutes positive health and wellbeing (salutogenesis). This was highlighted recently in a systematic review of reviews of intrapartum reported outcomes where only 8% of 1648 individual outcomes, from 102 systematic reviews, were agreed as being salutogenically-focused. Added to this is variation in the outcomes measured in individual studies rendering it very difficult for researchers to synthesise, fully, the evidence from studies on a particular topic. One of the suggested ways to address this is to develop and apply an agreed standardised set of outcomes, known as a 'core outcome set' (COS). In this paper we present a protocol for the development of a salutogenic intrapartum COS (SIPCOS) for use in maternity care research and a SIPCOS for measuring in daily intrapartum clinical care.Methods: The study proposes three phases in developing the final SIPCOSs. Phase one, which is complete, involved the conduct of a systematic review of reviews to identify a preliminary list of salutogenically-focused outcomes that had previously been reported in systematic reviews of intrapartum interventions. Sixteen unique salutogenically-focused outcome categories were identified. Phase two will involve prioritising these outcomes, from the perspective of key stakeholders (users of maternity services, clinicians and researchers) by asking them to rate the importance of each outcome for inclusion in the SIPCOSs. A final consensus meeting (phase three) will be held, bringing international stakeholders together to review the preliminary SIPCOSs resulting from the survey and to agree and finalise the final SIPCOSs for use in future maternity care research and daily clinical care.Discussion: The expectation in developing the SIPCOSs is that they will be collected and reported in all future studies evaluating intrapartum interventions and measured/recorded in future intrapartum clinical care, as routine, alongside other outcomes also deemed important in the context of the study or clinical scenario. Using the SIPCOSs in this way, will promote and encourage standardised measurements of positive health outcomes in maternity care, into the future. [ABSTRACT FROM AUTHOR]

Background: Postoperative adverse events are known to increase length of stay and cost. However, research on how adverse events affect patient flow and operational performance has been relatively limited to date. Moreover, there is paucity of studies on the use of simulation in understanding the effect of complications on care processes and resources. In hospitals with scarcity of resources, postoperative complications can exert a substantial influence on hospital throughputs. Methods: This paper describes an evaluation method for assessing the effect of complications on patient flow within a cardiac surgical department. The method is illustrated by a case study where actual patient-level data are incorporated into a discrete event simulation (DES) model. The DES model uses patient data obtained from a large hospital in Oman to quantify the effect of complications on patient flow, costs and surgical throughputs. We evaluated the incremental increase in resources due to treatment of complications using Poisson regression. Several types of complications were examined such as cardiac complications, pulmonary complications, infection complications and neurological complications. Results: 48 % of the patients in our dataset experienced one or more complications. The most common types of complications were ventricular arrhythmia (16 %) followed by new atrial arrhythmia (15.5 %) and prolonged ventilation longer than 24 h (12.5 %). The total number of additional days associated with infections was the highest, while cardiac complications have resulted in the lowest number of incremental days of hospital stay. Complications had a significant effect on perioperative operational performance such as surgery cancellations and waiting time. The effect was profound when complications occurred in the Cardiac Intensive Care (CICU) where a limited capacity was observed. Conclusions: The study provides evidence supporting the need to incorporate adverse events data in resource planning to improve hospital performance. [ABSTRACT FROM AUTHOR]

Background: Concern exists regarding the potential for chiropractic treatment to cause adverse effects in individuals with scoliosis. The aim of this paper is to present the self-reported responses of 189 scoliosis patients over 3198 unique visits, collected over one calendar year from nine chiropractic clinics, regarding how they felt and the side effects they experienced immediately after chiropractic treatment. Methods: Thirty six private chiropractic clinics specializing in the treatment of scoliosis were asked to participate in a prospective study regarding the side-effects of the chiropractic treatment of scoliosis; 9 agreed to participate. A response form was provided to each scoliosis patient at the end of their clinic visit, and consisted of two questions: "How do you feel after your treatment today?" and "Did you experience any side-effects as a result of your treatment today?" Results: One hundred eighty nine informed consent forms were collected and 3198 response forms were collected, suggesting an average of 17 visits per patient. Patients reported feeling worse post-treatment after 5.0 % of the visits. The incidence of side-effects was 29.7 %. Muscle soreness accounted for 35.2 % of all side effects. 99.9 % of all side effects were classified as mild. Six moderate side-effects (sprains/strains) were reported out of 3,198 visits. There were no reported cases of severe side effects. Conclusion: Mild side effects were common, although the frequency was slightly lower than the average for chiropractic interventions. The rate of moderate side effects reported was one per 533 visits involving the care of 189 scoliosis patients surveyed from 9 chiropractic offices over a timeframe of one calendar year. No serious adverse events occurred that required medical attention, hospital stays, or surgical intervention. Based upon this preliminary data, side effects reported by scoliosis patients immediately after chiropractic treatment appear to be relatively common but generally benign. [ABSTRACT FROM AUTHOR]

Background: Ipilimumab is a fully human monoclonal antibody directed against cytotoxic T-lymphocyte antigen-4, a key negative regulator of T-cell activation approved by the Food and Drug Administration as of March 2011 for the treatment of metastatic melanoma. As a result of the up-regulation of the immune system, several immune-mediated adverse effects have been reported including colitis, dermatitis, hepatitis and rarely hypophysitis. The most frequent immune-mediated adverse effects described in literature include gastrointestinal toxicity such as diarrhea, colitis and case of colitis and ileitis. Case presentation: In this paper we report an interesting case of immune-mediate ileitis without colitis in a 54 years old woman with metastatic melanoma treated with ipilimumab. We also discuss about case management and the possible pathological mechanisms considering also previous reports. Conclusions: The aim of this article is to support further investigations concerning epigenetic and genetic analysis in order to personalize biological therapy and to reduce immune related adverse events observed after ipilimumab administration. [ABSTRACT FROM AUTHOR]

Background: Various international studies have shown that a substantial number of patients suffer from injuries or even die as a result of care delivered in hospitals. The occurrence of injuries among patients caused by health care management in Dutch hospitals has never been studied systematically. Therefore, an epidemiological study was initiated to determine the incidence, type and impact of adverse events among discharged and deceased patients in Dutch hospitals. Methods/Design: Three stage retrospective patient record review study in 21 hospitals of 8400 patient records of discharged or deceased patients in 2004. The records were reviewed by trained nurses and physicians between August 2005 and October 2006. In addition to the determination of presence, the degree of preventability, and causes of adverse events, also location, timing, classification, and most responsible specialty of the adverse events were measured. Moreover, patient and admission characteristics and the quality of the patient records were recorded. Discussion: In this paper we report on the design of the retrospective patient record study on the occurrence of adverse events in Dutch hospitals. Attention is paid to the strengths and limitations of the study design. Furthermore, alterations made in the original research protocol in comparison with former international studies are described in detail. [ABSTRACT FROM AUTHOR]

Background: The Angiotensin Converting Enzyme (ACE) insertion/deletion (I/D) polymorphism has received much attention in pharmacogenetic research because observed variations in response to ACE inhibitors might be associated with this polymorphism. Pharmacogenetic testing raises the hope to individualise ACE inhibitor therapy in order to optimise its effectiveness and to reduce adverse effects for genetically different subgroups. However, the extent of its effect modification in patients treated with ACE inhibitors remains inconclusive. Therefore our objective is to quantify the effect modification of the insertion/deletion polymorphism of the angiotensin converting enzyme gene on any surrogate and clinically relevant parameters in patients with cardiovascular diseases, diabetes, renal transplantation and/or renal failure. Methods: Systematic Review. We will perform literature searches in six electronic databases to identify randomised controlled trials comparing the effectiveness and occurrence of adverse events of ACE inhibitor therapy against placebo or any active treatment stratified by the I/D gene polymorphism. In addition, authors of trials, experts in pharmacogenetics and pharmaceutical companies will be contacted for further published or unpublished data. Hand searching will be accomplished by reviewing the reference lists of all included studies. The methodological quality of included papers will be assessed. Data analyses will be performed in clinically and methodologically cogent subgroups. The results of the quantitative assessment will be pooled statistically where appropriate to produce an estimate of the differences in the effect of ACE inhibitors observed between the three ACE genotypes. Discussion: This protocol describes a strategy to quantify the effect modification of the ACE polymorphism on ACE inhibitors in relevant clinical domains using meta-epidemiological research methods. The results may provide evidence for the usefulness of pharmacogenetic testing for individualised ACE inhibitor therapy. [ABSTRACT FROM AUTHOR]

Background: Reactions are commonly associated with the chemotherapy of onchocerciasis. However unmanageable reactions are uncommon when ivermectin (Mectizan®) is used for the treatment of this infection, and this drug has proved to be a great improvement over previously used agents. Serious adverse events (SAE) nevertheless have occurred, and there is considerable concern about the negative effect such events may have on mass drug administration programs. This paper reviews the basic pathogenic mechanisms that can be involved in the destruction of microfilaria by chemotherapeutic agents. A central challenge to filarial chemotherapy is the need to remove parasites from biologically sensitive tissues, a more difficult medical challenge than eliminating nematodes from the gastrointestinal tract. Explanations for the etiology of the serious adverse reactions occurring with ivermectin treatment in specific geographic areas where there is coincident heavy Loa loa infections are hampered by a lack of specific pathological case material. Ways to investigate these possibilities are reviewed. Possible pathogenic mechanisms include embolic vascular pathology accompanied by local inflammation, blood brain barrier mdr1 abnormalities, and genetic predisposition to excessive inflammatory responses. Conclusion: It is important to keep ivermectin, and all its associated adverse clinical events, in perspective with the many other chemotherapeutic agents in general use—many of which produce serious adverse events even more frequently than does ivermectin. Currently available evidence indicates that the pathogenesis of the Loa-associated adverse reactions are probably related to inflammatory responses to microfilariae in specific tissues. However, the possibility of genetic predispositions to pathology should also be considered. [ABSTRACT FROM AUTHOR]

This paper presents a summary of reported cases of Serious Adverse Events (SA's) following treatment with Mectizan® (ivermectin, Merck, Sharpe & Dohme) in onchocerciasis mass treatment programs from January 1, 1989 to December 31, 2001 through a passive surveillance system. A total of 207 SAE cases were reported out of approximately 165 million reported treatments delivered during the period under review, giving rise to a cumulative incidence of 1 reported SAE per 800,000 reported treatments. The mean age was 40 years and 70% of the cases were males. The mean time between ivermectin intake and onset of illness was 1 day. For 57% of the cases (n = 118), that was their first exposure to ivermectin. The majority of cases were reported from Cameroon (n = 176; 85%) with peaks in the incidence of SAE reporting in 1989—1991 and 1994—1995 when the program expanded to ivermectin-naïve populations. Fifty-five percent of the cases from Cameroon (i.e. 97 out of 176 cases) were encephalopathic and were reported from the central-southern region of the country; two-thirds of these cases were 'probable' or 'possible' cases of Loa loa encephalopathy temporally related to ivermectin treatment. Reporting bias may explain some but not all of the differences in SAE reporting between the 34 onchocerciasis-endemic countries that have, or have had, mass treatment programs. Further research is needed to understand the apparent clustering of encephalopathy cases in central-southern Cameroon since L. loa infection alone probably does not explain the increased incidence of this type of SAE from this region. [ABSTRACT FROM AUTHOR]

Background: Patient safety in primary care is an emerging field of research with a growing evidence base in western countries but little has been explored in the Gulf Cooperation Council Countries (GCC) including the Sultanate of Oman. This study aimed to review the literature on the safety culture and patient safety measures used globally to inform the development of safety culture among health care workers in primary care with a particular focus on the Middle East. Methods: A systematic review of the literature. Searches were undertaken using Medline, EMBASE, CINAHL and Scopus from the year 2000 to 2014. Terms defining safety culture were combined with terms identifying patient safety and primary care. Results: The database searches identified 3072 papers that were screened for inclusion in the review. After the screening and verification, data were extracted from 28 papers that described safety culture in primary care. The global distribution of the articles is as follows: the Netherlands (7), the United States (5), Germany (4), the United Kingdom (1), Australia, Canada and Brazil (two for each country), and with one each from Turkey, Iran, Saudi Arabia and Kuwait. The characteristics of the included studies were grouped under the following themes: safety culture in primary care, incident reporting, safety climate and adverse events. The most common theme from 2011 onwards was the assessment of safety culture in primary care (13 studies, 46%). The most commonly used safety culture assessment tool is the Hospital survey on patient safety culture (HSOPSC) which has been used in developing countries in the Middle East. Conclusions: This systematic review reveals that the most important first step is the assessment of safety culture in primary care which will provide a basic understanding to safety-related perceptions of health care providers. The HSOPSC has been commonly used in Kuwait, Turkey, and Iran. [ABSTRACT FROM AUTHOR]

Background: Cancer treatments are associated with a multitude of adverse events (AEs). While both nurses and physicians are involved in patient care delivery and AE assessment, very few studies have examined the differences between nurses' and physicians' reporting and perception of AEs. An approach was recently proposed to assess treatment burden based on reported AEs from the physician's perspective. In this paper, we use this approach to evaluate nurses' perception of burden, and compare nurses' and physicians' assessment of the overall and relative burden of AEs.Methods: AE records for 334 cancer patients from a randomized clinical trial conducted by the SWOG Cancer Research Network were evaluated by 14 nurses at Columbia University Medical Center. Two nurses were randomly selected to assign a burden score from 0 to 10 based on their impression of the global burden of the captured AEs. These nurses did not interact directly with the patients. Scores were compared to previously obtained physicians scores using paired T-test and Kappa statistic. Severity scores for individual AEs were obtained using mixed-effects models with nurses assessments, and were qualitatively compared to physicians'.Results: Given the same AEs, nurses' and physicians' perception of the burden of AEs differed. While nurses generally perceived the overall burden of AEs to be only slightly worse compared to physicians (mean average VAS score of 5.44 versus 5.14), there was poor agreement in the perception of AEs that were in mild to severe range. The percent agreement for a moderate or worse AE was 64% with a Kappa of 0.34. Nurses also assigned higher severity scores to symptomatic AEs compared to physicians (p < 0.05), such as gastrointestinal (4.77 versus 4.14), hemorrhage (5.07 versus 4.14), and pain (5.17 versus 4.14).Conclusions: These differences in the perception of burden of AEs can lead to different treatment decisions and symptom management strategies. Thus, having provider consistency, training, or a collaborative approach in follow-up care between nurses and physicians is important to ensure continuity in care delivery. Moreover, estimating overall burden from both physicians' and nurses' perspective, and comparing them may be useful for deciding when collaborations are warranted. [ABSTRACT FROM AUTHOR]

Background: The future of combined immunotherapy (a PD-1/PD-L1 plus a CTLA-4 antagonist) is very bright. However, besides improving efficacy, combined therapy increases treatment-related adverse events (TRAEs). Also, the clinical application is limited in some solid tumors.Methods: This paper purports to investigate the TRAEs for the combined immunotherapy aiming for a more appropriate utilization of immune checkpoint inhibitors (ICIs) in clinical practice through a meta-analysis.Results: A total of 17 eligible studies covering 2626 patients were selected for a meta-analysis based on specified inclusion and exclusion criteria. The incidence rates of any grade and grade 3 or higher TRAEs were 88% (95%CI, 84-92%) and 41% (95%CI, 35-47%), respectively. The overall incidence of any grade TRAEs leading to discontinuation of treatment was 20% (95%CI, 16-24%). The incidence rate of treatment related deaths was 4.3‰ (95%CI, 1.4‰-8.4‰). Analysis showed that NIVO1 + IPI3 cohort had higher incidences of grade 3 or higher TRAEs (RR = 1.77, 95%CI, 1.34-2.34, p < 0.0001) and any grade TRAEs leading to discontinuation of treatment (RR = 1.81, 95%CI, 1.08-3.04, P = 0.02), compared with NIVO3 + IPI1 regimen.Conclusions: The combined therapy had high TRAEs. The TRAEs, especially grade 3 or higher, led to discontinuation of the treatment. Furthermore, the incidence of treatment-related deaths was rare. Moreover, the NIVO3 + IPI1 regimen, regardless of efficacy, is more recommended because of better tolerance and lower adverse events. [ABSTRACT FROM AUTHOR]

Background: There is evidence that the physician response rate is declining. In response to this, methods for increasing the physician response rate are currently being explored. This paper examines the response rate and extent of non-response bias in a mixed-mode study of Minnesota physicians.Methods: This mode experiment was embedded in a survey study on the factors that influence physicians' willingness to disclose medical errors and adverse events to patients and their families. Physicians were randomly selected from a list of licensed physicians obtained from the Minnesota Board of Medical Practice. Afterwards, they were randomly assigned to either a single-mode (mail-only or web-only) or mixed-mode (web-mail or mail-web) design. Differences in response rate and nonresponse bias were assessed using Fischer's Exact Test.Results: The overall response rate was 18.60%. There were no statistically significant differences in the response rate across modes (p - value = 0.410). The non-response analysis indicates that responders and non-responders did not differ with respect to speciality or practice location.Conclusions: The mode of administration did not affect the physician response rate. [ABSTRACT FROM AUTHOR]

Background: Adverse drug events (ADEs) as well as other preventable adverse events in the hospital setting incur a yearly monetary cost of approximately $3.5 billion, in the United States alone. Therefore, it is of paramount importance to reduce the impact and prevalence of ADEs within the healthcare sector, not only since it will result in reducing human suffering, but also as a means to substantially reduce economical strains on the healthcare system. One approach to mitigate this problem is to employ predictive models. While existing methods have been focusing on the exploitation of static features, limited attention has been given to temporal features.Methods: In this paper, we present a novel classification framework for detecting ADEs in complex Electronic health records (EHRs) by exploiting the temporality and sparsity of the underlying features. The proposed framework consists of three phases for transforming sparse and multi-variate time series features into a single-valued feature representation, which can then be used by any classifier. Moreover, we propose and evaluate three different strategies for leveraging feature sparsity by incorporating it into the new representation.Results: A large-scale evaluation on 15 ADE datasets extracted from a real-world EHR system shows that the proposed framework achieves significantly improved predictive performance compared to state-of-the-art. Moreover, our framework can reveal features that are clinically consistent with medical findings on ADE detection.Conclusions: Our study and experimental findings demonstrate that temporal multi-variate features of variable length and with high sparsity can be effectively utilized to predict ADEs from EHRs. Two key advantages of our framework are that it is method agnostic, i.e., versatile, and of low computational cost, i.e., fast; hence providing an important building block for future exploitation within the domain of machine learning from EHRs. [ABSTRACT FROM AUTHOR]