Laparoscopy-assisted versus balloon enteroscopy-assisted ERCP after Roux-en-Y gastric bypass

Endoscopy ◽  
2020 ◽  
Vol 52 (08) ◽  
pp. 654-661 ◽  
Author(s):  
Christer Julseth Tønnesen ◽  
Juliet Young ◽  
Tom Glomsaker ◽  
Tom Mala ◽  
Magnus Løberg ◽  
...  
Keyword(s):  
Gastric Bypass ◽  
Adverse Events ◽  
Tertiary Care ◽  
Patient Characteristics ◽  
Biliary Disease ◽  
Success Rates ◽  
Serious Adverse Events ◽  
Balloon Enteroscopy ◽  
Increased Risk ◽  
Concomitant Cholecystectomy

Background Patients who have undergone Roux-en-Y gastric bypass (RYGB) are at increased risk of biliary disease necessitating endoscopic retrograde cholangiopancreatography (ERCP). The most widely used approaches to perform ERCP after RYGB are laparoscopy-assisted ERCP (LA-ERCP) and balloon enteroscopy-assisted ERCP (BEA-ERCP). There are few studies comparing these procedures. We aimed to compare the performance, benefits, and harms of LA-ERCP and BEA-ERCP in RYGB patients. Methods We identified all RYGB patients who underwent ERCP at two tertiary care endoscopy centers in Oslo, Norway between May 2013 and December 2017. One center performed BEA-ERCP, the other LA-ERCP. Procedure success was defined as fulfillment of the therapeutic or diagnostic aim, according to the procedure description. Adverse events were classified according to the Clavien–Dindo grading system. Results During the study period, 40 BEA-ERCP and 39 LA-ERCP procedures were performed in 68 patients. Procedure success rate was 72.5 % for BEA-ERCP and 87.2 % for LA-ERCP (P = 0.14). Adverse events occurred in 18 % of BEA-ERCP and 28 % of LA-ERCP (P = 0.23). Serious adverse events (Clavien–Dindo grade ≥ 3b) occurred in 2.5 % of BEA-ERCP and 7.7 % of LA-ERCP procedures (P = 0.36). Concomitant cholecystectomy was performed in 25 of the 39 LA-ERCP procedures. The median procedure times for LA-ERCP performed with and without concomitant cholecystectomy were 201 minutes and 140 minutes, respectively, and for BEA-ERCP was 125 minutes. Conclusions In experienced hands, both LA-ERCP and BEA-ERCP have high success rates after RYGB. The choice of approach should be individualized according to patient characteristics and available physician competence.

scholarly journals 416 - Risk of Mortality Associated with Antipsychotics in Alzheimer's Disease

2020 ◽  
Vol 32 (S1) ◽  
pp. 132-132
Author(s):  
Liliana P. Ferreira ◽  
Núria Santos ◽  
Nuno Fernandes ◽  
Carla Ferreira
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Adverse Events ◽  
Mortality Risk ◽  
Antipsychotic Treatment ◽  
Serious Adverse Events ◽  
Risk Of Death ◽  
Mesh Terms ◽  
Risk Of Mortality ◽  
Increased Risk

Objectives: Alzheimer's disease (AD) is the most common cause of dementia and it is associated with increased mortality. The use of antipsychotics is common among the elderly, especially in those with dementia. Evidence suggests an increased risk of mortality associated with antipsychotic use. Despite the short-term benefit of antipsychotic treatment to reduce the behavioral and psychological symptoms of dementia, it increases the risk of mortality in patients with AD. Our aim is to discuss the findings from the literature about risk of mortality associated with the use of antipsychotics in AD.Methods: We searched Internet databases indexed at MEDLINE using following MeSH terms: "Antipsychotic Agents" AND "Alzheimer Disease" OR "Dementia" AND "Mortality" and selected articles published in the last 5 years.Results: Antipsychotics are widely used in the pharmacological treatment of agitation and aggression in elderly patients with AD, but their benefit is limited. Serious adverse events associated with antipsychotics include increased risk of death. The risk of mortality is associated with both typical and atypical antipsychotics. Antipsychotic polypharmacy is associated with a higher mortality risk than monotherapy and should be avoided. The mortality risk increases after the first few days of treatment, gradually reducing but continues to increase after two years of treatment. Haloperidol is associated with a higher mortality risk and quetiapine with a lower risk than risperidone.Conclusions: If the use of antipsychotics is considered necessary, the lowest effective dose should be chosen and the duration should be limited because the mortality risk remains high with long-term use. The risk / benefit should be considered when choosing the antipsychotic. Further studies on the efficacy and risk of adverse events with antipsychotics are needed for a better choice of treatment and adequate monitoring with risk reduction.

scholarly journals 32 Quantifying the Prevalence of Frailty in Drug Trials and the Relationship with Serious Adverse Events

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i7-i11
Author(s):  
P Hanlon ◽  
E Butterly ◽  
J Lewsey ◽  
S Siebert ◽  
F S Mair ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Adverse Events ◽  
Disease Severity ◽  
Negative Binomial ◽  
Frailty Index ◽  
Chronic Obstructive ◽  
Drug Trials ◽  
Phase 3 ◽  
Serious Adverse Events ◽  
Increased Risk

Abstract Introduction Frailty is common in clinical practice, but trials rarely report on participant frailty. Consequently, clinicians and guideline-developers assume frailty is largely absent from trials and have questioned the relevance of trial findings to frail people. Therefore, we examined frailty in phase 3/4 industry-sponsored clinical trials of pharmacological interventions for three exemplar conditions: type 2 diabetes mellitus (T2DM), rheumatoid arthritis (RA), and chronic obstructive pulmonary disease (COPD). Methods We constructed a 40-item frailty index (FI) in 19 clinical trials (7 T2DM, 8 RA, 4 COPD, mean age 42–65 years) using individual-level participant data. Participants with a FI >0.24 were considered “frail”. Baseline disease severity was assessed using HbA1c for T2DM, Disease Activity Score-28 (DAS28) for RA, and % predicted FEV1 for COPD. Using generalised gamma regression, we modelled FI on age, sex and disease severity. In negative binomial regression we modelled serious adverse event rates on FI, and combined results for each index condition in a random-effects meta-analysis. Results All trials included frail participants: prevalence 7–21% in T2DM trials, 33–73% in RA trials, and 15–22% in COPD trials. Increased disease severity and female sex were associated with higher FI in all trials. Frailty was associated with age in T2DM and RA trials, but not in COPD. Across all trials, and after adjusting for age, sex, and disease severity, higher FI predicted increased risk of serious adverse events; the pooled incidence rate ratios (per 0.1-point increase in FI scale) were 1.46 (95% CI 1.21–1.75), 1.45 (1.13–1.87) and 1.99 (1.43–2.76) for T2DM, RA and COPD, respectively. Conclusion Frailty is identifiable and prevalent among middle aged and older participants in phase 3/4 drug trials and has clinically important safety implications. Trial data may be harnessed to better understand chronic disease management in people living with frailty.

scholarly journals Factors associated with mechanical and systemic adverse events after colonoscopy (France, 2010-2015)

2019 ◽  
Vol 29 (Supplement_4) ◽  
Author(s):  
M Laanani ◽  
A Weill ◽  
P O Blotière ◽  
J Pouchot ◽  
F Carbonnel ◽  
...  
Keyword(s):  
Renal Failure ◽  
Acute Renal Failure ◽  
Adverse Events ◽  
Older Patients ◽  
Public Hospitals ◽  
Serious Adverse Events ◽  
Logistic Regression Models ◽  
Factors Associated ◽  
Increased Risk ◽  
Experienced Endoscopists

Abstract Background More than one million colonoscopies are performed every year in France. They are associated with risks of mechanical and systemic serious adverse events (SAEs) which can be associated with patient, procedure, endoscopist, and facility characteristics. We tried to identify the factors associated with colonic perforation, gastrointestinal bleeding, splenic injury, shock, myocardial infarction, stroke, pulmonary embolism, acute renal failure, and urolithiasis after colonoscopy. Methods We analysed data from the French national claims databases (SNDS). A total of 4,088,799 patients, 30 years or older, undergoing a first screening or diagnostic colonoscopy between 2010 and 2015 were identified. SAE rates were estimated, and risk factors associated with SAEs were identified using multilevel logistic regression models, adjusted for patient, colonoscopy, endoscopist, and facility characteristics. Results Increasing age was associated with an increasing incidence of mechanical and systemic SAEs. Cancer and cardiovascular comorbidities were associated with mechanical SAEs, and a higher number of pre-existing conditions was associated with shock and acute renal failure. Polypectomy, especially of polyps larger than 1 cm, was associated with an increased risk of perforation (OR = 4.1; 95% CI, 3.4-5.0) and bleeding (OR = 13.3; 95% CI, 11.7-15.1). Mechanical SAEs were associated with the endoscopist’s experience, while systemic SAEs were more frequent in public hospitals than in private clinics. Conclusions SAEs related to colonoscopy were more frequent in older patients and in those with comorbidities. Mechanical SAEs were more frequent when colonoscopy was performed by less experienced endoscopists. Systemic SAEs were more frequent in public hospitals, reflecting patient selection processes. The risk of both mechanical and systemic SAEs should be taken into account when deciding to perform colonoscopy, particularly in older patients with multiple pre-existing conditions. Key messages Systemic SAEs are not uncommon after colonoscopy and, together with intestinal SAEs, should be considered when considering the need for colonoscopy. Patients at risk of SAEs should be identified and colonoscopy should be performed by experienced endoscopists in these patients. Less invasive alternatives should also be considered in these patients.

scholarly journals Evidence for cannabis and cannabinoids for epilepsy: a systematic review of controlled and observational evidence

2018 ◽  
Vol 89 (7) ◽  
pp. 741-753 ◽  
Author(s):  
Emily Stockings ◽  
Dino Zagic ◽  
Gabrielle Campbell ◽  
Megan Weier ◽  
Wayne D Hall ◽  
...  
Keyword(s):  
Adverse Events ◽  
Seizure Frequency ◽  
Observational Studies ◽  
Number Needed To Treat ◽  
Seizure Freedom ◽  
Low Grade ◽  
Serious Adverse Events ◽  
Seizure Reduction ◽  
Increased Risk ◽  
Randomised Controlled

Review evidence for cannabinoids as adjunctive treatments for treatment-resistant epilepsy. Systematic search of Medline, Embase and PsycINFO was conducted in October 2017. Outcomes were: 50%+ seizure reduction, complete seizure freedom; improved quality of life (QoL). Tolerability/safety were assessed by study withdrawals, adverse events (AEs) and serious adverse events (SAEs). Analyses were conducted in Stata V.15.0. 36 studies were identified: 6 randomised controlled trials (RCTs), 30 observational studies. Mean age of participants was 16.1 years (range 0.5–55 years). Cannabidiol (CBD) 20 mg/kg/day was more effective than placebo at reducing seizure frequency by 50%+(relative risk (RR) 1.74, 95% CI 1.24 to 2.43, 2 RCTs, 291 patients, low Grades of Recommendation, Assessment, Development and Evaluation (GRADE) rating). The number needed to treat for one person using CBD to experience 50%+ seizure reduction was 8 (95% CI 6 to 17). CBD was more effective than placebo at achieving complete seizure freedom (RR 6.17, 95% CI 1.50 to 25.32, 3 RCTs, 306 patients, low GRADE rating), and improving QoL (RR 1.73, 95% CI 1.33 to 2.26), however increased risk of AEs (RR 1.24, 95% CI 1.13 to 1.36) and SAEs (RR 2.55, 95% CI 1.48 to 4.38). Pooled across 17 observational studies, 48.5% (95% CI 39.0% to 58.1%) of patients reported 50%+ reductions in seizures; in 14 observational studies 8.5% (95% CI 3.8% to 14.5%) were seizure-free. Twelve observational studies reported improved QoL (55.8%, 95% CI 40.5 to 70.6); 50.6% (95% CI 31.7 to 69.4) AEs and 2.2% (95% CI 0 to 7.9) SAEs. Pharmaceutical-grade CBD as adjuvant treatment in paediatric-onset drug-resistant epilepsy may reduce seizure frequency. Existing RCT evidence is mostly in paediatric samples with rare and severe epilepsy syndromes; RCTs examining other syndromes and cannabinoids are needed.PROSPERO registration numberCRD42017055412.

scholarly journals Immune-Related Adverse Events Requiring Hospitalization: Spectrum of Toxicity, Treatment, and Outcomes

2019 ◽  
Vol 15 (9) ◽  
pp. e825-e834 ◽  
Author(s):  
Aanika Balaji ◽  
Jiajia Zhang ◽  
Beatriz Wills ◽  
Kristen A. Marrone ◽  
Hany Elmariah ◽  
...  
Keyword(s):  
Adverse Events ◽  
Checkpoint Inhibitors ◽  
Patient Characteristics ◽  
Spectrum Management ◽  
Service Planning ◽  
Inpatient Service ◽  
High Demand ◽  
Academic Center ◽  
Increased Risk ◽  
Oncology Center

PURPOSE: Immune checkpoint inhibitors (ICIs) cause immune-related adverse events (irAEs). The proportion of patients who are hospitalized for irAEs and their spectrum, management, and outcomes are not well described. METHODS: We report the proportion of hospitalized patients in an academic center who were treated with ICIs from May to December 2017. Patient characteristics, toxicities, management, and outcomes for confirmed irAE admissions are reported. Associations between patient features and irAE hospitalizations are examined. RESULTS: Twenty-three percent (n = 100) of 443 patients who were admitted to an academic oncology center over 6 months had ever received ICIs. Of these patients, 41% were admitted for suspected irAEs and 23% were confirmed irAEs. IrAEs accounted for 5% of all oncology hospitalizations (n = 23). Ninety-one percent of patients with confirmed irAEs prompted a medicine subspecialist consultation, most commonly gastroenterology (22%). Fifteen patients (65%) had their irAEs improve/resolve, seven (30%) had worsening irAEs, and three (13%) died of their irAEs. The majority of patients (n = 20; 87%) discontinued ICIs after discharge. Among ICI-treated patients who required admission, an increased likelihood of irAE-related hospitalization was associated with patient age older than 65 years (odds ratio, 5.4; 95% CI, 1.6 to 17.8) and receipt of combination immunotherapy (OR, 6.8; 95% CI, 2.0 to 23.2). CONCLUSION: A notable proportion of ICI-treated patients are hospitalized for irAEs, and these patients have a high demand for multidisciplinary management. Older age and combination ICI treatment were associated with an increased risk of irAE-related hospitalization. Whereas these data are from an academic center and include patients in clinical trials, with expanding use of ICIs, these data have important implications for inpatient service planning and risk stratification.

scholarly journals Endoscopic biliary self-expandable metallic stent in malignant biliary obstruction with or without sphincterotomy: systematic review and meta-analysis

2019 ◽  
Vol 07 (01) ◽  
pp. E26-E35 ◽  
Author(s):  
Benedetto Mangiavillano ◽  
Amedeo Montale ◽  
Leonardo Frazzoni ◽  
Mario Bianchetti ◽  
Amrita Sethi ◽  
...  
Keyword(s):  
Adverse Events ◽  
Success Rate ◽  
Meta Analysis ◽  
Stent Insertion ◽  
Metallic Stent ◽  
Success Rates ◽  
Technical Success ◽  
Technical Success Rate ◽  
Expandable Metallic Stent ◽  
Increased Risk

Abstract Background and aim To assess the rate of adverse events and the technical success rate of biliary stenting with or without EBS.  Methods A literature search up to February 2017 was performed. Studies assessing adverse events (AEs) and technical success rates of stenting with or without EBS were considered. Results Seven studies (870 patients; 12 treatment arms) were included. Early AEs, i. e. those occurring within 30 days, were significantly lower in no-EBS vs. EBS-group (11 % vs. 20.1 %; OR: 0.36, 95 %CI: 0.13 – 1.00). Rates of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis were not significantly different in the two groups (no-EBS vs. EBS: 6.1 % vs 5 %; OR: 1.33, 95 %CI: 0.68 – 2.59). The rate of bleeding was significantly lower in patients without EBS (no-EBS vs EBS: 0 % vs 5 %; OR: 0.12, 95 % CI: 0.03 – 0.45). Rates of cholangitis were significantly lower in patients without EBS (no-EBS vs. EBS: 3.3 % vs. 7.4 %; OR: 0.38, 95 %CI: 0.17 – 0.83). Both late AEs and mortality rates did not significantly differ between no-EBS and EBS patients (19.9 % vs. 18.9 %; OR: 0.93, 95 %CI: 0.56 – 1.53, and 2.5 % vs. 2.9 %; OR: 1.18, 95 %CI: 0.22 – 6.29, respectively). The technical success rate for stent insertion also did not differ (98 % vs. 97.6 %; OR: 1.05, 95 %CI: 0.42 – 2.63). Conclusion EBS seems to be associated, in the first 30 days after the procedure, with an increased risk of cholangitis and bleeding. No difference was observed in the rate of post-ERCP pancreatitis.

Phase II Trial of Standard Dose Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (CHOP) and Rituximab (R-CHOP) Plus Bevacizumab for Advanced Stage Diffuse Large B-Cell (DLBCL) NHL: Southwest Oncology Group Study S0515

Blood ◽  
2010 ◽  
Vol 116 (21) ◽  
pp. 591-591 ◽  
Author(s):  
Alison T. Stopeck ◽  
Joseph M Unger ◽  
Lisa M. Rimsza ◽  
Brent Farnsworth ◽  
Michael LeBlanc ◽  
...  
Keyword(s):  
Adverse Events ◽  
Standard Dose ◽  
Immunohistochemical Analysis ◽  
Patient Characteristics ◽  
Tissue Microarrays ◽  
Left Ventricular ◽  
Serious Adverse Events ◽  
Significant Toxicity ◽  
Southwest Oncology Group Study ◽  
Grade 3

Abstract Abstract 591 Introduction: VEGF and VEGF receptors (VEGFR) are frequently over-expressed in DLBCL. Elevated levels of circulating VEGF have also been associated with a worse prognosis and resistance to chemotherapy. This trial was initiated to determine if the addition of anti-VEGF targeted therapy to standard R-CHOP would improve PFS without adding significant toxicity in previously untreated patients with stage III, IV or bulky stage II DLBCL. Methods: 64 eligible patients were treated with standard dose R-CHOP plus bevacizumab administered at 15mg/kg on day1. Patients received therapy every 21 days for a maximum of 8 cycles. Both biologics were administered prior to chemotherapy. Pretreatment tumor biopsies from 40 patients were submitted for construction of tissue microarrays for VEGF/VEGFR immunohistochemical analysis. Two 1 mm tissue cores were assessed for each DLBCL specimen and expression of VEGF and VEGFR scored on a scale of 0 (no expression) to +3 (strong expression) by 2 pathologists. Both lymphoma and endothelial cell (blood vessel) staining was assessed with the higher score being recorded. Results: 73 patients were enrolled with 9 patients found ineligible, the majority (n = 7) secondary to incorrect histology. Patient characteristics for the 64 eligible patients included: median age 68 years with 77% of the patients over 60 years (age range: 22–85), 44 males, IPI scores: 3 low, 22 low-intermediate, 29 high-intermediate, and 8 high. Median follow-up is 2.0 years. Based on prior studies, and adjusted for the observed IPI factor frequencies seen in this study, the projected 1 year historical PFS rate in this population would be 71%, while the observed 1 year PFS estimate was 77% (95% CI: 66 – 87%). The PFS estimate at 2-years was 69% (95% CI: 57 – 80%). The 1 and 2 year overall survival estimates were 86% and 79%, respectively. Among all patients (including ineligibles), a total of 30 patients experienced 40 serious adverse events (SAE) while on study. The majority of SAE were hematologic, but also included 2 patients with sudden death, 5 patients with GI perforations (4 occurring after cycle 1), and 5 patients with grade 3 or 4 thrombotic events. Additional adverse events of interest included 7 patients who developed hypertension (4 patients with grade 3), and 13 patients who developed grade 2 or 3 left ventricular dysfunction. VEGF expression was observed in 98% (IHC scoring: +1 in 18%, +2 in 38%, and +3 in 43%) of lymphoma cells and VEGFR was expressed in 95% (IHC scoring:+1 in 28%, +2 in 40%, and +3 in 28%) of blood vessels by immunohistochemistry analysis. Conclusions: Despite high protein expression of VEGF and VEGFR in newly diagnosed DLBCL specimens, the addition of bevacizumab to standard R-CHOP chemotherapy did not significantly improve PFS from expected results with R-CHOP alone. Although the observed 1-year PFS estimate trended higher than the historical estimate, a target PFS of 81% was pre-specified as warranting further investigation. Significant toxicities were associated with the addition of bevacizumab, including an increased incidence of cardiac dysfunction and GI perforation. Our results do not support additional studies of this regimen in this patient population. Disclosures: Stopeck: Genentech: Consultancy, Honoraria, Speakers Bureau. Off Label Use: Bevacizumab therapy in NHL. Fisher:Roche: Consultancy.

Patients’ Knowledge Of Anticoagulation and Its Association With Clinical Characteristics, INR Control and Warfarin-Related Adverse Events

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 1738-1738 ◽  
Author(s):  
Poupak Rahmani ◽  
Charlotte L. Guzman ◽  
Mark D Blostein ◽  
Ashley Tabah ◽  
Alla Muladzanov ◽  
...  
Keyword(s):  
Adverse Events ◽  
Conflicts Of Interest ◽  
Tertiary Care ◽  
Mechanical Heart Valve ◽  
Standard Of Care ◽  
Patient Characteristics ◽  
Bleeding Events ◽  
Chi Square ◽  
Level Of Knowledge ◽  
One Year

Abstract Background Whether level of knowledge of anticoagulation (AC) among patients on warfarin plays a role in maintenance of therapeutic INR or in warfarin-related adverse events is controversial. Most studies conducted on this subject had small patient sample sizes and did not use validated questionnaires to assess patients’ knowledge of AC. Objectives To use the validated Oral Anticoagulation Knowledge (OAK) test (Zeolla MM, 2006) to assess knowledge of AC among patients attending a busy AC clinic, and to examine associations between level of knowledge, INR control and adverse events. We hypothesized that patients with higher OAK test scores (i.e. greater knowledge) would have better INR control (primary outcome) and fewer bleeding and thrombosis events (secondary outcomes). Methods Consecutive patients who had been followed in our AC clinic (tertiary care, university-affiliated hospital, 20,000 patient-visits per year) for at least one year and consented to participate were asked to complete the OAK test. The OAK test is a 20-question multiple-choice questionnaire that assesses patients’ knowledge of warfarin AC. A passing score is ≥15 correct responses. Patient charts were reviewed to obtain data on clinical and demographic characteristics, and information on INR values and any thrombosis or bleeding events during the preceding 1 year period. Associations between OAK scores and patient characteristics, INR control and bleeding/thrombosis events were assessed by chi-square and t-tests, as appropriate. Results Among 252 patients screened for participation, 225 met the inclusion criteria and completed the OAK test. Mean (SD) age was 70 (13.4) years, 53% were male and 75% were on warfarin for >3 years. Indications for AC were atrial fibrillation in 65%, VTE in 8%, mechanical heart valve in 10%, and other in 19%. The mean OAK score was 12/20, and 64% failed the OAK test. Predictors of a pass score on the OAK test were younger age (p= 0.01) and higher level of education (p=0.03). Over the preceding year, 57.3% of INRs were therapeutic, 25.1% subtherapeutic and 17.4% supratherapeutic, and there were 22 bleeding events and 5 thrombosis events. There was no association between OAK score and INR control, or OAK score and bleeding or thrombosis events. Conclusion To our knowledge, this is the first study to use the validated OAK test to assess patients’ AC knowledge. We found that younger and more educated patients were more likely to pass the OAK test; however, OAK test result did not predict INR control or occurrence of bleeding or thrombotic events. The OAK test may not be sensitive enough to capture the standard of care practiced in different anticoagulation clinics (e.g. differences in teaching material, frequency of INR checks in stable patients). Also, for some patients, AC knowledge among their caretakers may be more important than self-knowledge. Further research is needed to assess the relationship between AC knowledge, INR control and adverse clinical outcomes. Disclosures: No relevant conflicts of interest to declare.

scholarly journals Lower risk for serious adverse events and no increased risk for cancer after PBSC vs BM donation

Blood ◽  
2014 ◽  
Vol 123 (23) ◽  
pp. 3655-3663 ◽  
Author(s):  
Michael A. Pulsipher ◽  
Pintip Chitphakdithai ◽  
Brent R. Logan ◽  
Willis H. Navarro ◽  
John E. Levine ◽  
...  
Keyword(s):  
Adverse Events ◽  
Lower Risk ◽  
Granulocyte Colony Stimulating Factor ◽  
Colony Stimulating Factor ◽  
Serious Adverse Events ◽  
Increased Risk ◽  
Key Points ◽  
Life Threatening ◽  
Stimulating Factor

Key Points BM donors have a threefold higher risk for life-threatening, serious unexpected, or chronic adverse events vs PBSC donors (0.99% vs 0.31%). Donors receiving granulocyte colony-stimulating factor for PBSC collection had no evidence of increased risk for cancer, autoimmune illness, and stroke.

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

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