Browsing by Subject "Adverse events"
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Item Association between poor tolerability of antidepressant treatment and brain functional activation in youth at risk for bipolar disorder(Brazilian Psychiatric Association, 2021-02-01) Nery, Fabiano G.; Masifi, Sheela L.; Strawn, Jeffrey R.; Duran, Luis R.; Weber, Wade A.; Welge, Jeffrey A.; Adler, Caleb M.; Strakowski, Stephen M.; DelBello, Melissa P.; Psychiatry, School of MedicineObjective: To investigate whether poor antidepressant tolerability is associated with functional brain changes in children and adolescents of parents with bipolar I disorder (at-risk youth). Methods: Seventy-three at-risk youth (ages 9-20 years old) who participated in a prospective study and had an available baseline functional magnetic resonance imaging (fMRI) scan were included. Research records were reviewed for the incidence of adverse reactions related to antidepressant exposure during follow-up. The sample was divided among at-risk youth without antidepressant exposure (n=21), at-risk youth with antidepressant exposure and no adverse reaction (n=12), at-risk youth with antidepressant-related adverse reaction (n=21), and healthy controls (n=20). The fMRI task was a continuous performance test with emotional distracters. Region-of-interest mean activation in brain areas of the fronto-limbic emotional circuit was compared among groups. Results: Right amygdala activation in response to emotional distracters significantly differed among groups (F3,66 = 3.1, p = 0.03). At-risk youth with an antidepressant-related adverse reaction had the lowest amygdala activation, while at-risk youth without antidepressant exposure had the highest activation (p = 0.004). Conclusions: Decreased right amygdala activation in response to emotional distracters is associated with experiencing an antidepressant-related adverse reaction in at-risk youth. Further studies to determine whether amygdala activation is a useful biomarker for antidepressant-related adverse events are needed.Item Cohort profile: measuring adverse pregnancy and newborn congenital outcomes (MANGO) study in Kenya(BMJ, 2025-04-30) Humphrey, John M.; Chepkemoi, Audrey; Brown, Steven; Carlucci, James G.; McPheron, Molly; Kerich, Caroline; Matelong, Winnie; Kooreman, Harold; McHenry, Megan S.; Bernard, Caitlin; Kiano, Marylydia; Musick, Beverly S.; Yiannoutsos, Constantin T.; Wools-Kaloustian, Kara; Patel, Rena C.; Were, Edwin; EA-IeDEA consortium; Medicine, School of MedicinePurpose: Pharmacovigilance (PV) systems to assess the safety of antiretroviral treatment used periconception and during pregnancy are lacking in low-resource settings with high HIV burdens, and strategies to guide their implementation are limited. We implemented the Measuring Adverse Pregnancy and Newborn Congenital Outcomes (MANGO) study in Kenya to address these gaps. Participants: In MANGO, we ascertained delivery outcomes for pregnant women living with HIV (WLH) and not living with HIV (WNLH) enrolled in care at Moi Teaching and Referral Hospital (MTRH) through two cohorts: C1, a prospective cohort of 1:1 matched WLH and WNLH attending antenatal clinic; and C2, a cross-sectional cohort of all deliveries, including among those who did not attend antenatal clinic at MTRH. Findings to date: 24 205 deliveries were recorded from October 2020 to September 2023 (853 in C1 and 23 352 in C2). Median maternal age was 32 years, 4.5% were WLH and 2.6% of deliveries were stillbirths. Among liveborn infants, 17.2% were preterm (<37 weeks), and 15.1% were low birth weight (<2.5 kg). Prevalence of ≥1 major congenital abnormality was 73.9/10 000 births (47.7 in C1 and 76.1 in C2). Assessing implementation barriers/facilitators, lack of national PV policy was a barrier overcome through establishing partnerships with the Kenya Ministry of Health. The facility's size and complexity were barriers to newborn surface exam coverage overcome through staff training and cocreation of a standardised form for newborn surface exam documentation. High staff turnover was addressed by involving head nurses to champion implementation and incentivising staff participation with medical education credits. Use of audit/feedback cycles and focusing on PV as a way to improve care quality facilitated PV institutionalisation at MTRH. Future plans: The MANGO model is a multifaceted strategy with replicative potential in other settings. Research is needed to understand the model's opportunities for implementation in other settings.Item Does ChAdOx1-S and BNT162b2 heterologous prime-boost vaccination trigger higher rates of vaccine-related adverse events?(Elsevier, 2023) Haji, Alhan; Alkattan, Abdallah; Mahmoud, Nagla; Elkagam, Elfadil; Hassanein, Mustafa; Alfaifi, Amal; Al-Tawfiq, Jaffar A.; Alabdulkareem, Khaled; Jokhdar, Hani; Radwan, Nashwa; Medicine, School of MedicineBackground: There has been significant international interest in heterologous prime-boost COVID-19 vaccination. However, it is linked with different intensity and frequency of adverse events. This study aimed to assess the safety of ChAdOx1-S and BNT162b2 vaccines when given as heterologous prime-boost vaccination in Saudi Arabia. Methods: A cross-sectional study was conducted during the period October 2021 to March 2022. The study included two groups of people based on the type of vaccination regimen. The first group (heterologous) was subjected to different prime-boost vaccination schedules irrespective of the prime and boost vaccine types. The second group included people vaccinated with the same type of COVID-19 vaccine (homologous). Results: The overall sample included 334 participants. Those included in the heterologous group were at about 1.5 fold -increased risk for developing local and systemic adverse events compared to the homologous group. Fever, headache, and vomiting were significantly more frequent among the heterologous group compared to the homologous group (p-value<0.05). In both groups, more than half of the recorded adverse events were mild/moderate in severity. Conclusion: Heterologous prime-post vaccination is associated with a slightly increased risk for the development of local and systemic adverse events compared to the homologous regimen. However, most of these adverse events are mild/moderate in nature and recede within two days with no serious adverse events documented.Item Early experience with resmetirom to treat metabolic dysfunction–associated steatohepatitis with fibrosis in a real-world setting(Wolters Kluwer, 2025-04-03) Ravela, Neel; Shackelford, Phoebe; Blessing, Nadia; Yoder, Lindsay; Chalasani, Naga; Samala, Niharika; Medicine, School of MedicineBackground: Resmetirom was conditionally approved in the United States recently for treating metabolic dysfunction-associated steatohepatitis with stage 2 and 3 fibrosis. However, its availability to patients requires preauthorization by the payors and is dispensed only through selected specialty pharmacies. Methods: We established a multistakeholder and multistep resmetirom prescription process pivoting to a dedicated pharmacist. It incorporates liver biochemistry testing at 12 weeks and liver clinic follow-up at 6 months after starting resmetirom. Results: Fifteen hepatology providers prescribed resmetirom to 113 patients from April 1, 2024, to November 8, 2024, with histologic eligibility in 70% and noninvasive criteria in 30%. Resmetirom treatment was approved for 110 patients (97%), including 8 patients receiving the pharmaceutical company's patient assistance and 6 patients receiving bridge support to cover the co-pay. Eighty-three patients initiated resmetirom at an average of 30 days after its prescription. Adverse events were reported by 41% of patients taking resmetirom, and they were predominantly related to gastrointestinal symptoms and pruritus and/or rash with no evidence of hypersensitivity. Thirteen patients (16%) discontinued resmetirom after an average of 25.5 days (range: 2-68 d), with 11 patients discontinuing due to adverse events. The adverse events leading to discontinuation were nausea, diarrhea, and vomiting (n=4), right upper quadrant discomfort (n=2), left lower quadrant pain (n=1), rash with pruritus (n=1), pruritus and rash with indirect hyperbilirubinemia (n=1), dizziness (n=1), and mental fogginess (n=1). Follow-up liver biochemistries available in 24 patients showed no evidence of DILI. Conclusions: Our prescription pathway effectively dispensed resmetirom to nearly all patients who were prescribed resmetirom. One in 6 patients discontinued resmetirom, primarily due to side effects. This high discontinuation rate may be mitigated by modifying our follow-up from "prescribe and forget" to "prescribe and closely follow."Item Early solicited adverse events following the BNT162b2 mRNA vaccination, a population survey from Saudi Arabia(Elsevier, 2021-10-11) Almohaya, Abdulellah M.; Qari, Farah; Zubaidi, Ghuzlan A.; Alnajim, Noura; Moustafa, Khadeeja; Alshabi, Malak M.; Alsubaie, Faleh M.; Almutairi, Ibrahim; Alwazna, Qusai; Al-Tawfiq, Jaffar A.; Barry, Mazin; Medicine, School of MedicinePost rollout safety for the coronavirus disease vaccines is crucial and recommended. To explore the early solicited adverse events (AE) following BNT162b2 mRNA vaccination in Saudi Arabia, we distributed an online survey to adults vaccinated with BNT162b2 over the first week of June 2021, to collect data on first (V1), second doses (V2), symptoms, severity, and outcome after an informed consent was obtained. We recruited 3639 BNT162b2 vaccinated individuals, of which one-third had received two doses, 63.3% were female, 77% were healthy, and 89% had 18–55 years of age, while only 9.8% had a history of allergy. Overall, 50.3% had any AEs after any dose, especially those younger than 55 years of age, female, history of comorbidity, and when adjusted for age and gender, lung or cardiovascular diseases. Overall, the most common AE were pain at the injection site (44%), tiredness (39%), or body ache (31%). Compared to V1, a higher rate of post-V2 systemic AE (36% vs. 51%). Most AEs started very early (within 3 days), and rarely delayed in recovery (>2 weeks). Anti-pyretic was the most commonly used (51.7%), a third of which was unnecessary. Only 1.7% required hospital admission. By multivariate analysis, predictors for admission were the presence of lung or immunocompromising diseases. In conclusion, common AEs after BNT162b2 in the real world were generally mild, self-limiting, higher after the second dose, and largely mimicking that reported in clinical trials. The causality of these AE and the persistence of post-vaccination symptoms needs to be investigated further.Item Identifying Inconsistencies and Reporting Deficits in Therapeutic Massage and Bodywork (TMB) Case Reports Authored by TMB Practitioners: a TMB-Adapted CAse REport (CARE) Guidelines Audit Through 2014(Massage Therapy Foundation, 2016-09-09) Munk, Niki; Shue, Sarah; Freeland, Emilee; Ralston, Rick K.; Boulanger, Karen T.; Department of Health Sciences, School of Health and Rehabilitation SciencesINTRODUCTION: Case reports are a fundamental tool through which therapeutic massage and bodywork (TMB) practitioners can inform research and impact their field by detailing the presentation, treatment, and follow-up of a single individual encountered in practice. Inconsistencies in case reporting limit their impact as fundamental sources of clinical evidence. Using the TMB-adapted CAse REport (CARE) guidelines, the current study sought to provide a rich description regarding the reporting quality of TMB practitioner authored TMB case reports in the literature. METHODS: 1) Systematic identification of published, peer-reviewed TMB case reports authored by TMB practitioners following PRISMA recommendations; 2) audit development based on TMB-adapted CARE guidelines; 3) audit implementation; and 4) descriptive analysis of audit scores. RESULTS: Our search identified 977 articles and 35 met study inclusion criteria. On average, TMB case reports included approximately 58% of the total items identified as necessary by the TMB-adapted CARE guidelines. Introduction sections of case reports had the best item reporting (80% on average), while Case Presentation (54%) and Results (52%) sections scored moderately overall, with only 20% of necessary Practitioner Description items included on average. Audit scores revealed inconsistent abstract reporting and few audited case reports including client race (20%), perspective (26%), and occupation/activities (40%); practitioner practice setting (12%), training (12%), scope-of-practice (29%), and credentialing (20%); adverse events or lack thereof (17%); and some aspect of informed consent (34%). Treatment descriptor item reporting varied from high to low. Various implications of concern are discussed. CONCLUSION: The current audit and descriptive analysis highlight several reporting inconsistencies in TMB case reports prior to 2015. Reporting guidelines for case reports are important if standards for, and impact of, TMB case reports are desired. Adherence to reporting specifications outlined by the TMB-adapted CARE guidelines could improve the impact and usability of TMB case reports in research, education, and practice.Item Improving Interpreter Access in the Pediatric Emergency Department: A Quality Improvement Initiative(Wolters Kluwer, 2024-07-10) Douglas, Katherine E.; Fox, Miriam T.; Cheston, Christine C.; Behara, M. Laxmi; Schoppel, Kyle A.; Emergency Medicine, School of MedicineBackground: An increasing proportion of the population in the United States have limited English proficiency (LEP). Hospitals that receive federal funding must offer interpreter services. However, access is often lacking for patients. Patients with LEP are at higher risk for adverse events, and the Emergency Department is a particularly high-risk environment for these events. Methods: This quality improvement initiative took place from April 2021 to August 2022 in an urban, tertiary care Pediatric Emergency Department. A driver diagram informed four Plan-Do-Study-Act cycles, and data were collected through medical record review, patient surveys, and staff surveys. We tracked outcomes using run and control chart data. Results: During the study period, the proportion of patients with LEP reporting "always" having an interpreter was unchanged (no centerline shift-control chart rules). Documentation of interpreter use for encounters with patients with LEP improved. Preferred language documentation and documentation of the need for an interpreter in the electronic medical record showed no change. Process measure data for staff-reported use of professional interpreters significantly increased, and the use of ad hoc interpreters decreased significantly. Length of stay did not change for English or LEP patients. Conclusions: This quality improvement initiative improved appropriate documentation of LEP and decreased use of nonqualified interpreters, although no change occurred in the proportion of patients who reported always having an interpreter. Patient satisfaction was unaffected.Item Improving the Approach to Defining, Classifying, Reporting and Monitoring Adverse Events in Seriously Ill Older Adults: Recommendations from a Multi-stakeholder Convening(Springer, 2023) Baim-Lance, Abigail; Ferreira, Katelyn B.; Cohen, Harvey Jay; Ellenberg, Susan S.; Kuchel, George A.; Ritchie, Christine; Sachs, Greg A.; Kitzman, Dalane; Morrison, R. Sean; Siu, Albert; Medicine, School of MedicineBackground: Clinical trials are needed to study topics relevant to older adults with serious illness. Investigators conducting clinical trials with this population are challenged by how to appropriately define, classify, report, and monitor serious and non-serious adverse events (SAEs/AEs), given that some traditionally reported AEs (pressure ulcers, delirium) and SAEs (death, hospitalization) are common in persons with serious illness, and may be consistent with their goals of care. Objectives: A multi-stakeholder group convened to establish greater clarity on and new approaches to address this critical issue. Participants: Thirty-two study investigators, members of regulatory and sponsor agencies, and patient stakeholders took part. Approach: The group met virtually four times and, using a collaborative approach, conducted a survey, select interviews, and reviewed regulatory guidance to collectively define the problem and identify a new approach. Results: SAE/AE challenges fell into two areas: (1) definitions and classifications, including (a) implausible relationships, (b) misalignment with patient-centered care goals, and (c) well-known associations, and (2) reporting and monitoring, including (a) limited guidance, (b) inconsistent standards across regulators, and (c) Data Safety Monitoring Board (DSMB) member knowledge gaps. Problems largely reflected practice norms rather than regulatory requirements that already support context-specific and aggregate reporting. Approaches can be improved by adopting principles that better align strategies for addressing adverse events with the type of intervention being tested, favoring routine and aggregate over expedited reporting, and prioritizing how SAE/AEs relate to patient-centered care goals. Reporting plans and decisions should follow an algorithm underpinned by these principles. Conclusions: Adoption of the proposed approach-and supporting it with education and better alignment with regulatory guidance and procedures-could improve the quality and efficiency of clinical trials' safety involving older adults with serious illness and other vulnerable populations.Item Overall Adverse Event Profile of Vadadustat versus Darbepoetin Alfa for the Treatment of Anemia Associated with Chronic Kidney Disease in Phase 3 Trials(Karger, 2022) Agarwal, Rajiv; Anand, Sanjeev; Eckardt, Kai-Uwe; Luo, Wenli; Parfrey, Patrick S.; Sarnak, Mark J.; Solinsky, Christine M.; Vargo, Dennis L.; Winkelmayer, Wolfgang C.; Chertow, Glenn M.; Medicine, School of MedicineIntroduction: Anemia frequently occurs in chronic kidney disease (CKD), is associated with poor quality of life and cardiovascular outcomes, and its treatment represents a considerable economic burden to the healthcare system. Although effective, the current standard of care for the treatment of anemia in chronic kidney disease patients with erythropoiesis-stimulating agents requires chronic/ongoing injections, making the treatment less accessible or desirable to patients not treated by in-center maintenance hemodialysis. Furthermore, safety concerns, including an increased risk of cardiovascular events and mortality, have emerged from their use in studies targeting hemoglobin concentrations in the normal or near-normal range. The orally active hypoxia-inducible factor prolyl hydroxylase inhibitor vadadustat may offer advantages over erythropoiesis-stimulating agents by correcting anemia via pathways activating endogenous erythropoietin production. Methods: To comprehensively analyze the safety profile of vadadustat in patients with dialysis-dependent and non-dialysis-dependent CKD-related anemia, we pooled the safety populations from each of the four trials in the phase 3 clinical program (n = 7,373) and compared the risk of treatment-emergent adverse events (TEAEs) for each treatment arm. Results: In patients randomized to vadadustat versus darbepoetin alfa, rates of TEAEs (88.9% vs. 89.3%), treatment-emergent serious adverse events (58.0% vs. 59.3%), and TEAEs leading to death (16.1% vs. 16.2%) were similar, as were rates of adverse events of special interest, including cardiovascular-, hepatic-, and neoplasm-related adverse events. Discussion/conclusion: Among patients with CKD-related anemia treated with vadadustat, we observed similar rates of adverse events relative to those treated with darbepoetin alfa.Item Pattern of self-reported adverse events related to COVID-19 vaccines in Saudi Arabia: A nationwide study(Frontiers Media, 2023-02-23) Alkhalifah, Joud Mohammed; Al Seraihi, Ahad; Al-Tawfiq, Jaffar A.; Alshehri, Badr Fadhel; Alhaluli, Alhanouf Hani; Alsulais, Naif Mansour; Alessa, Mohammed Mesfer; Seddiq, Waleed; Aljeri, Thamer; Qahtani, Mohammad Hassan; Barry, Mazin; Al-Otaiby, Maram; Medicine, School of MedicineBackground: Vaccination against coronavirus disease 2019 (COVID-19) is the most effective way to end the pandemic. Any development of adverse events (AEs) from various vaccines should be reported. We therefore aimed to explore major and minor AEs among vaccinated individuals in Saudi Arabia. Methods: This is a nationwide report based on the Saudi Arabian Ministry of Health (MOH) registry. It included those who received COVID-19 vaccines from 17th December 2020 to 31st December 2021. The study included spontaneous self-reported adverse effects to COVID-19 vaccines where the study participants used a governmental mobile app (Sehhaty) to report their AEs following vaccination using a checklist option that included a selection of side-effects. The primary outcome was to determine AEs reported within 14 days of vaccination which included injection site itching, pain, reaction, redness, swelling, anxiety, dizziness, fever, headache, hoarseness, itchiness, loss of consciousness, nausea, heartburn, sleep disruption, fatigue, seizures, anaphylaxis, shortness of breath, wheezing, swelling of lips, face, and throat, loss of consciousness, and admissions into the intensive care unit (ICU). Results: The study included a total number of 28,031 individuals who reported 71,480 adverse events (AEs); which were further classified into minor and major adverse events including ICU admissions post vaccination. Of the reported AEs, 38,309 (53. 6%) side-effects were reported following Pfizer-BioNTech, 32,223 (45%) following Oxford-AstraZeneca, and 948 (1.3%) following Moderna. The following reported AEs were statistically significant between the different vaccine types: shortness of breath\difficulty of breathing, dizziness, fever above 39°C, headache, hoarseness, injection site reactions, itchiness, nausea, sleep disruption, fatigue, wheezing, swelling of lips/face and\or throat, and loss of consciousness (p-value < 0.05). Fever and seizure were the only statistically significant AEs amongst the number of vaccine doses received (p-value < 0.05). Ten ICU admissions were reported in the 14 days observation period post-COVID-19 vaccination with the following diagnoses: acute myocardial infarction, pneumonia, atherosclerosis, acute respiratory failure, intracranial hemorrhage, grand mal seizure, Guillain-Barré syndrome, abnormal blood gas levels, and septic shock. Conclusion: This study demonstrated that the most prevalent SARS-CoV-2 vaccine side-effects among adults in Saudi Arabia were mild in nature. This information will help reduce vaccine hesitancy and encourage further mass vaccination to combat the COVID-19 pandemic, especially as booster doses are now available. Further studies are warranted to obtain a better understanding of the association between risk factors and the experiencing of side-effects post vaccination.