scholarly journals Association between human papillomavirus vaccination and serious adverse events in South Korean adolescent girls: nationwide cohort study

BMJ ◽  
2021 ◽  
pp. m4931 ◽  
Author(s):  
Dongwon Yoon ◽  
Ji-Ho Lee ◽  
Hyesung Lee ◽  
Ju-Young Shin
Keyword(s):  
Cohort Study ◽  
Adverse Events ◽  
Incidence Rate ◽  
Adolescent Girls ◽  
Cohort Analysis ◽  
Hpv Vaccination ◽  
Secondary Analysis ◽  
Primary Analysis ◽  
Serious Adverse Events ◽  
Adjusted Rate

Abstract Objective To evaluate the association between human papillomavirus (HPV) vaccination and serious adverse events in adolescent girls in South Korea. Design Cohort study. Setting A large linked database created by linking the Korea Immunization Registry Information System and the National Health Information Database, between January 2017 and December 2019. Participants 441 399 girls aged 11-14 years who had been vaccinated in 2017: 382 020 had been vaccinated against HPV and 59 379 had not been vaccinated against HPV. Main outcome measures Outcomes were 33 serious adverse events, including endocrine, gastrointestinal, cardiovascular, musculoskeletal, haematological, dermatological, and neurological diseases. A cohort design was used for the primary analysis and a self-controlled risk interval design for the secondary analysis; both analyses used a risk period of one year after HPV vaccination for each outcome. Incidence rate and adjusted rate ratios were estimated using Poisson regression in the primary analysis, comparing the HPV vaccinated group with the HPV unvaccinated group, and adjusted relative risks were estimated using conditional logistic regression in the secondary analysis. Results Among the 33 predefined serious adverse events, no associations were found with HPV vaccination in the cohort analysis, including Hashimoto’s thyroiditis (incidence rate per 100 000 person years: 52.7 v 36.3 for the vaccinated and unvaccinated groups; adjusted rate ratio 1.24, 95% confidence interval 0.78 to 1.94) and rheumatoid arthritis (incidence rate per 100 000 person years: 168.1 v 145.4 for the vaccinated and unvaccinated groups; 0.99, 0.79 to 1.25), with the exception of an increased risk observed for migraine (incidence rate per 100 000 person years: 1235.0 v 920.9 for the vaccinated and unvaccinated groups; 1.11, 1.02 to 1.22). Secondary analysis using self-controlled risk intervals confirmed no associations between HPV vaccination and serious adverse events, including migraine (adjusted relative risk 0.67, 95% confidence interval 0.58 to 0.78). Results were robust to varying follow-up periods and for vaccine subtypes. Conclusions In this nationwide cohort study, with more than 500 000 doses of HPV vaccines, no evidence was found to support an association between HPV vaccination and serious adverse events using both cohort analysis and self-controlled risk interval analysis. Inconsistent findings for migraine should be interpreted with caution considering its pathophysiology and the population of interest.

scholarly journals HPV vaccines for prevention of cervical pre-cancer in adolescent girls and women

2019 ◽  
Vol 1 (2) ◽  
pp. 112
Author(s):  
Jia Jian Li ◽  
Jessica Stetz
Keyword(s):  
Adverse Events ◽  
Adolescent Girls ◽  
Meta Analysis ◽  
Hpv Vaccination ◽  
Hpv Infection ◽  
Significant Benefit ◽  
Hpv Vaccines ◽  
Serious Adverse Events

The evidence presented in this Cochrane meta-analysis shows the HPV vaccination confers significant benefit in preventing cervical pre-cancer. NNT of 60 for preventing one cervical pre-cancer (women 15 to 25 years old with or without HPV infection). The effect is higher for lesions associated with HPV16/18. The data also demonstrates an absence of serious adverse events. Therefore, we have assigned a color recommendation of Green (Benefit > Harm) to this vaccine.

scholarly journals Outcomes associated with hospital admissions for accidental opioid overdose in British Columbia: a retrospective cohort study

BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e025567
Author(s):  
Richard L Morrow ◽  
Ken Bassett ◽  
Malcolm Maclure ◽  
Colin R Dormuth
Keyword(s):  
British Columbia ◽  
Cohort Study ◽  
Adverse Events ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Secondary Analysis ◽  
Secondary Outcome ◽  
Opioid Overdose ◽  
Composite Outcome ◽  
Serious Adverse Events

ObjectivesTo study the association between accidental opioid overdose and neurological, respiratory, cardiac and other serious adverse events and whether risk of these adverse events was elevated during hospital readmissions compared with initial admissions.DesignRetrospective cohort study.SettingPopulation-based study using linked administrative data in British Columbia, Canada.ParticipantsThe primary analysis included 2433 patients with 2554 admissions for accidental opioid overdose between 2006 and 2015, including 121 readmissions within 1 year of initial admission. The secondary analysis included 538 patients discharged following a total of 552 accidental opioid overdose hospitalizations and 11 040 matched controls from a cohort of patients with ≥180 days of prescription opioid use.Outcome measuresThe primary outcome was encephalopathy; secondary outcomes were adult respiratory distress syndrome, respiratory failure, pulmonary haemorrhage, aspiration pneumonia, cardiac arrest, ventricular arrhythmia, heart failure, rhabdomyolysis, paraplegia or tetraplegia, acute renal failure, death, a composite outcome of encephalopathy or any secondary outcome and total serious adverse events (all-cause hospitalisation or death). We analysed these outcomes using generalised linear models with a logistic link function.Results3% of accidental opioid overdose admissions included encephalopathy and 25% included one or more adverse events (composite outcome). We found no evidence of increased risk of encephalopathy (OR 0.57; 95% CI 0.13 to 2.49) or other outcomes during readmissions versus initial admissions. In the secondary analysis, <5 patients in each cohort experienced encephalopathy. Risk of the composite outcome (OR 2.15; 95% CI 1.48 to 3.12) and all-cause mortality (OR 2.13; 95% CI 1.18 to 3.86) were higher for patients in the year following overdose relative to controls.ConclusionsWe found no evidence that risk of encephalopathy or other adverse events was higher in readmissions compared with initial admissions for accidental opioid overdose. Risk of serious morbidity and mortality may be elevated in the year following an accidental opioid overdose.

scholarly journals POS0647 EFFICACY, SAFETY AND CHARACTERISTICS OF IGURATIMOD-BASED THERAPY IN THE TREATMENT OF UA, ERA AND RA PATIENTS FOR 24 WEEKS: A PROSPECTIVE COHORT STUDY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 561.2-562
Author(s):  
X. Liu ◽  
Z. Sun ◽  
W. Guo ◽  
F. Wang ◽  
L. Song ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Cohort Study ◽  
Adverse Events ◽  
Disease Activity ◽  
Prospective Cohort Study ◽  
Early Rheumatoid Arthritis ◽  
Prospective Cohort ◽  
Combined Treatment ◽  
Serious Adverse Events

Background:Experts emphasize early diagnosis and treatment in RA, but the widely used diagnostic criterias fail to meet the accurate judgment of early rheumatoid arthritis. In 2012, Professor Zhanguo Li took the lead in establishing ERA “Chinese standard”, and its sensitivity and accuracy have been recognized by peers. However, the optimal first-line treatment of patients (pts) with undifferentiated arthritis (UA), early rheumatoid arthritis (ERA), and rheumatoid arthritis (RA) are yet to be established.Objectives:To evaluate the efficacy and safety of Iguratimod-based (IGU-based) Strategy in the above three types of pts, and to explore the characteristics of the effects of IGU monotherapy and combined treatment.Methods:This prospective cohort study (ClinicalTrials.gov Identifier NCT01548001) was conducted in China. In this phase 4 study pts with RA (ACR 1987 criteria[1]), ERA (not match ACR 1987 criteria[1] but match ACR/EULAR 2010 criteria[2] or 2014 ERA criteria[3]), UA (not match classification criteria for ERA and RA but imaging suggests synovitis) were recruited. We applied different treatments according to the patient’s disease activity at baseline, including IGU monotherapy and combination therapies with methotrexate, hydroxychloroquine, and prednisone. Specifically, pts with LDA and fewer poor prognostic factors were entered the IGU monotherapy group (25 mg bid), and pts with high disease activity were assigned to combination groups. A Chi-square test was applied for comparison. The primary outcomes were the proportion of pts in remission (REM)or low disease activity (LDA) that is DAS28-ESR<2.6 or 3.2 at 24 weeks, as well as the proportion of pts, achieved ACR20, Boolean remission, and good or moderate EULAR response (G+M).Results:A total of 313 pts (26 pts with UA, 59 pts with ERA, and 228 pts with RA) were included in this study. Of these, 227/313 (72.5%) pts completed the 24-week follow-up. The results showed that 115/227 (50.7%), 174/227 (76.7%), 77/227 (33.9%), 179/227 (78.9%) pts achieved DAS28-ESR defined REM and LDA, ACR20, Boolean remission, G+M response, respectively. All parameters continued to decrease in all pts after treatment (Fig 1).Compared with baseline, the three highest decline indexes of disease activity at week 24 were SW28, CDAI, and T28, with an average decline rate of 73.8%, 61.4%, 58.7%, respectively. Results were similar in three cohorts.We performed a stratified analysis of which IGU treatment should be used in different cohorts. The study found that the proportion of pts with UA and ERA who used IGU monotherapy were significantly higher than those in the RA cohort. While the proportion of triple and quadruple combined use of IGU in RA pts was significantly higher than that of ERA and UA at baseline and whole-course (Fig 2).A total of 81/313 (25.8%) pts in this study had adverse events (AE) with no serious adverse events. The main adverse events were infection(25/313, 7.99%), gastrointestinal disorders(13/313, 4.15%), liver dysfunction(12/313, 3.83%) which were lower than 259/2666 (9.71%) in the previous Japanese phase IV study[4].The most common reasons of lost follow-up were: 1) discontinued after remission 25/86 (29.1%); 2) lost 22/86 (25.6%); 3) drug ineffective 19/86 (22.1%).Conclusion:Both IGU-based monotherapy and combined therapies are tolerant and effective for treating UA, ERA, and RA, while the decline in joint symptoms was most significant. Overall, IGU combination treatments were most used in RA pts, while monotherapy was predominant in ERA and UA pts.References:[1]Levin RW, et al. Scand J Rheumatol 1996, 25(5):277-281.[2]Kay J, et al. Rheumatology 2012, 51(Suppl 6):vi5-9.[3]Zhao J, et al. Clin Exp Rheumatol 2014, 32(5):667-673.[4]Mimori T, et al. Mod Rheumatol 2019, 29(2):314-323.Disclosure of Interests:None declared

Incidence of serious adverse events in bortezomib, lenalidomide and bortezomib plus lenalidomide maintenance for multiple myeloma: Interim analysis of MMRF-CoMMpass study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. e19516-e19516
Author(s):  
Venkata Vosuri ◽  
Mark A Fiala ◽  
Wenners Ballard ◽  
Tanya Marya Wildes ◽  
Mark A. Schroeder ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Adverse Event ◽  
Stem Cell ◽  
Adverse Events ◽  
Maintenance Therapy ◽  
Incidence Rate ◽  
Interim Analysis ◽  
Therapy Group ◽  
Cell Transplant ◽  
Serious Adverse Events

e19516 Background: Autologous stem cell transplantation (ASCT) followed by maintenance therapy is the standard of care for transplant-eligible patients with newly diagnosed multiple myeloma. Maintenance typically consists of lenalidomide (LEN), however, bortezomib (BOR) and bortezomib-lenalidomide combination are other options. The respective toxicity of these regimens has not been well studied. We performed secondary data analysis to compare incidence of serious adverse events associated with each maintenance therapy group during post-ASCT maintenance treatment period. Methods: Data was extracted from the open-access MMRF Researcher Gateway corresponding with interim analysis from the CoMMpass study. We extracted data of first-time autologous stem cell transplant patients who completed maintenance therapy post-ASCT. We categorized patients into three sub groups bortezomib, lenalidomide or combination (bortezomib and lenalidomide) maintenance therapy. Incidence rate for serious adverse events (grade 3 or higher) was calculated by number of events per 100 person-months for each maintenance therapy. Results: 231 patients were eligible for our analysis. 169 patients received lenalidomide, 27 bortezomib and 35 combination. The most common adverse event was neutropenia and second most common is pneumonia. Neutropenia incidence was 1.1,0.7 and 0.9 per 100 person-months in lenalidomide, bortezomib and combination regimens respectively. Incidence of deep vein thrombosis, GI intolerance and peripheral neuropathy 0.1 per 100 person-months respectively was observed in lenalidomide group only. Combination maintenance had the highest total adverse event incidence rate of 5.4 per 100 person-months. Incidence of 1.7 and 3.8 per 100 person-months is observed in bortezomib and lenalidomide cohorts respectively. Conclusions: Lenalidomide and bortezomib maintenance had similar incidence of serious adverse events. A higher incidence of serious adverse events was noted in the combination lenalidomide/bortezomib regimens. Interestingly, we observed lower incidence of adverse events in all groups in CoMMpass study compared to respective clinical trials involving maintenance regimens. This may be due to under reporting of adverse events in CoMMpass study. The incidence of adverse events mentioned above should be interpreted in the context of drugs and other factors involved in the disease.

scholarly journals Effectiveness, safety and acceptability of no-test medical abortion provided via telemedicine: a national cohort study

2020 ◽  
Author(s):  
Abigail Aiken ◽  
Patricia Lohr ◽  
Jonathan Lord ◽  
Nabanita Ghosh ◽  
Jennifer Starling
Keyword(s):  
Cohort Study ◽  
Adverse Events ◽  
Ectopic Pregnancy ◽  
Hybrid Model ◽  
Waiting Times ◽  
Medical Abortion ◽  
Late Gestation ◽  
Success Rates ◽  
Serious Adverse Events ◽  
Patient Reported

Objective To compare the effectiveness, safety and acceptability of medical abortion before and after the introduction of no-test telemedicine Design Cohort study Setting The three main abortion providers in England Population All patients having an early medical abortion (comprising 85% of all medical abortions performed nationally) Methods Comparison of no-test telemedicine hybrid model vs. traditional model (blanket in-person provision including ultrasound), adjusted for baseline differences Main outcome measures Access: waiting time, gestation Effectiveness: successful medical abortion Safety: significant adverse events; ectopic pregnancy and late gestation Acceptability: Patient-reported outcomes Results 52,142 medical abortions were conducted, 29,984 in the telemedicine-hybrid cohort and 22,158 in the traditional cohort. Mean waiting times were 4.2 days shorter in the telemedicine-hybrid cohort and 40% were ≤6 weeks’ gestation vs. 25% in the traditional cohort (p<0.001). There was no difference in success rates (98.8% vs. 98.2%, p=1.0), nor in prevalence of serious adverse events (0.02% vs. 0.04%, p=0.557). Incidence of ectopic pregnancy was equivalent in both cohorts (0.2%, p=0.796); 0.04% of abortions appeared to have been provided after 10 weeks’ gestation with all completed safely at home. In the telemedicine-hybrid cohort, effectiveness was higher in the telemedicine group vs. the in-person group (99.2% vs. 98.1%, p<0.001). Acceptability was high (96% satisfied), 80% reported a future preference for telemedicine, and none reported that they were unable to consult in private using teleconsultation. Conclusions Medical abortion provided through a hybrid model that includes no-test telemedicine without ultrasound is effective, safe, acceptable, and improves access to care. Funding None

scholarly journals Validation of adverse events after hip arthroplasty: a Swedish multi-centre cohort study

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e023773 ◽  
Author(s):  
Martin Magnéli ◽  
Maria Unbeck ◽  
Cecilia Rogmark ◽  
Ola Rolfson ◽  
Ami Hommel ◽  
...  
Keyword(s):  
Cohort Study ◽  
Adverse Events ◽  
Incidence Rate ◽  
Hip Arthroplasty ◽  
Cumulative Incidence ◽  
Secondary Outcome ◽  
National Patient ◽  
Global Trigger Tool ◽  
Record Review ◽  
Hip Arthroplasties

ObjectivesPreventing adverse events (AEs) after orthopaedic surgery is a field with great room for improvement. A Swedish instrument for measuring AEs after hip arthroplasty based on administrative data from the national patient register is used by both the Swedish Hip Arthroplasty Register and the Swedish Association of Local Authorities and Regions. It has never been validated and its accuracy is unknown. The aim of this study was to validate the instrument’s ability to detect AEs, and to calculate the incidence of AEs following primary hip arthroplasties.DesignRetrospective cohort study using retrospective record review with Global Trigger Tool methodology in combination with register data.Setting24 different hospitals in four major regions of Sweden.Participants2000 patients with either total or hemi-hip arthroplasty were recruited from the SHAR. We included both acute and elective patients.Primary and secondary outcome measuresThe sensitivity and specificity of the instrument. Adjusted cumulative incidence and incidence rate.ResultsThe sensitivity for all identified AEs was 5.7% (95% CI: 4.9% to 6.7%) for 30 days and 14.8% (95% CI: 8.2 to 24.3) for 90 days, and the specificity was 95.2% (95% CI: 93.5% to 96.6%) for 30 days and 92.1% (95% CI: 89.9% to 93.8%) for 90 days. The adjusted cumulative incidence for all AEs was 28.4% (95% CI: 25.0% to 32.3%) for 30 days and 29.5% (95% CI: 26.0% to 33.8%) for 90 days. The incidence rate was 0.43 AEs per person-month (95% CI: 0.39 to 0.47).ConclusionsThe AE incidence was high, and most AEs occurred within the first 30 days. The instrument sensitivity for AEs was very low for both 30 and 90 days, but the specificity was high for both 30 and 90 days. The studied instrument is insufficient for valid measurements of AEs after hip arthroplasty.

scholarly journals Access to personal protective equipment in healthcare workers during the COVID-19 pandemic in the United Kingdom: results from a nationwide cohort study (UK-REACH)

2021 ◽  
Author(s):  
Christopher A Martin ◽  
Daniel Pan ◽  
Joshua Nazareth ◽  
Avinash Aujayeb ◽  
Luke Bryant ◽  
...  
Keyword(s):  
Cohort Study ◽  
United Kingdom ◽  
Personal Protective Equipment ◽  
Healthcare Workers ◽  
Secondary Analysis ◽  
Protective Equipment ◽  
Primary Analysis ◽  
Questionnaire Response ◽  
The United Kingdom ◽  
The Uk

Abstract Objectives: To determine the prevalence and predictors of self-reported access to appropriate personal protective equipment (aPPE) for healthcare workers (HCWs) in the United Kingdom (UK) during the first UK national COVID-19 lockdown (March 2020) and at the time of questionnaire response (December 2020 - February 2021). Design: Two cross sectional analyses using data from a questionnaire-based cohort study. Setting: Nationwide questionnaire from 4th December 2020 to 28th February 2021. Participants: A representative sample of HCWs or ancillary workers in a UK healthcare setting aged 16 or over, registered with one of seven main UK healthcare regulatory bodies. Main outcome measure: Binary measure of self-reported aPPE (access all of the time vs access most of the time or less frequently) at two timepoints: the first national lockdown in the UK (primary analysis) and at the time of questionnaire response (secondary analysis). Results: 10,508 HCWs were included in the primary analysis, and 12,252 in the secondary analysis. 3702 (35.2%) of HCWs reported aPPE at all times in the primary analysis; 6806 (83.9%) reported aPPE at all times in the secondary analysis. After adjustment (for age, sex, ethnicity, migration status, occupation, aerosol generating procedure exposure, work sector, work region, working hours, night shift frequency and trust in employing organisation), older HCWs (per decade increase in age: aOR 1.2, 95% CI 1.16 - 1.26, p<0.001) and those working in Intensive Care Units (1.61, 1.38 - 1.89, p<0.001) were more likely to report aPPE at all times. Those from Asian ethnic groups compared to White (0.77, 0.67 - 0.89, p<0.001), those in allied health professional (AHPs) and dental roles (vs those in medical roles; AHPs: 0.77, 0.68 - 0.87, p<0.001; dental: 0.63, 0.49 - 0.81, p<0.001), and those who saw a higher number of COVID-19 patients compared to those who saw none (≥21 patients 0.74, 0.61 - 0.90, p=0.003) were less likely to report aPPE at all times in the primary analysis. aPPE at all times was also not uniform across UK regions (reported access being better in South West and North East England than London). Those who trusted their employing organisation to deal with concerns about unsafe clinical practice, compared to those who did not, were twice as likely to report aPPE at all times (2.18, 1.97 - 2.40, p<0.001). With the exception of occupation, these factors were also significantly associated with aPPE at all times in the secondary analysis. Conclusions: We found that only a third of HCWs in the UK reported aPPE at all times during the period of the first lockdown and that aPPE had improved later in the pandemic. We also identified key sociodemographic and occupational determinants of aPPE during the first UK lockdown, the majority of which have persisted since lockdown was eased. These findings have important public health implications for HCWs, particularly as cases of infection and long-COVID continue to rise in the UK.

scholarly journals A Broad Safety Assessment of the 9-Valent Human Papillomavirus Vaccine

2021 ◽  
Author(s):  
W Katherine Yih ◽  
Martin Kulldorff ◽  
Inna Dashevsky ◽  
Judith C Maro
Keyword(s):  
Human Papillomavirus ◽  
Adverse Events ◽  
Multiple Testing ◽  
Statistical Power ◽  
Hpv Vaccination ◽  
Exposure Period ◽  
Human Papillomavirus Vaccine ◽  
Serious Adverse Events ◽  
Increased Risk

Abstract Surveys of parents indicate safety is their top concern about human papillomavirus (HPV) vaccination. A data-mining method not requiring pre-specification of health outcome(s) of interest or post-exposure period(s) of potentially increased risk can check for associations between an exposure and any of thousands of medically attended health outcomes. The method was applied to the 9-valent HPV vaccine (HPV9) to detect potential safety problems. Data on 9-26-year-olds who had received HPV9 vaccine between November 4, 2016 and August 5, 2018, inclusive, were extracted from Marketscan and analyzed for statistically significant clustering of incident diagnoses within the hierarchy of ICD-10-CM coded diagnoses and temporally within the 1 year after vaccination, using the self-controlled tree-temporal scan statistic and TreeScan software. Only 56 days of post-vaccination enrollment was required; subsequent follow-up was censored at disenrollment. Multiple testing was adjusted for. The analysis included 493,089 doses of HPV9. Almost all signals resulted from temporal confounding, not unexpected with a 1-year follow-up period. The only plausible signals were for non-specific adverse events (e.g., injection-site reactions and headache) on Days 1-2 after vaccination, with attributable risks as low as 1 per 100,000 vaccinees. Considering the broad scope of the evaluation and the high statistical power, the findings of no specific serious adverse events should provide reassurance about this vaccine’s safety.

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