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

2020 ◽  
Author(s):  
Abigail Aiken ◽  
Patricia A Lohr ◽  
Jonathan Lord ◽  
Nabanita Ghosh ◽  
Jennifer Starling
Keyword(s):  
Cohort Study ◽  
Adverse Events ◽  
Access To Care ◽  
Ectopic Pregnancy ◽  
Medical Abortion ◽  
Ultrasound Scan ◽  
Service Model ◽  
Abortion Care ◽  
Before And After ◽  
Future Preference

AbstractObjectivesTo compare the effectiveness, safety and acceptability of medical abortion before and after the introduction of no-test telemedicine abortion care.DesignCohort study to assess whether a no-test telemedicine-hybrid care model (telemedicine with in-person provision only when indicated) was non-inferior to the traditional service model (blanket in-person provision including ultrasound scan).SettingThe three main abortion providers in England and Wales.ParticipantsAll patients having an early medical abortion in the two months before and after the service model change. Patient demographic and clinical characteristics were compared between the cohorts to adjust for any systematic differences in the two groups.Main outcome measuresAccesswaiting time, gestation at abortionEffectivenessthe proportion of successful medical abortionsSafetysignificant adverse events defined as: haemorrhage requiring transfusion, significant infection requiring hospital admission, major surgery, death. We also examined the incidence of ectopic pregnancy and late gestation.AcceptabilityPatient-reported outcomes of satisfaction, future preference, and privacy of consultationResultsThe study sample included 52,142 medical abortions; 22,158 in the traditional cohort and 29,984 in the telemedicine-hybrid cohort, of which 61% were provided using no-test telemedicine. The cohorts accounted for 85% of all medical abortions provided in England and Wales during the study period. Mean waiting times were 4.2 days shorter in the telemedicine-hybrid cohort, and 40% were provided at ≤6 weeks’ gestation compared to 25% in the traditional cohort (p<0.001). There was no difference in success rates between the two groups (98.2% vs. 98.8%, p=1.0), nor in the prevalence of serious adverse events (0.04% vs. 0.02%, p=0.557). The incidence of ectopic pregnancy was equivalent in both cohorts (0.2%, p=0.796), with no significant difference in the proportions being treated after abortion (0.01% vs 0.03%, p=0.123). In 0.04% of cases the abortion appeared to have been provided at over 10 weeks’ gestation; these abortions were all completed at home without additional medical complications. In the telemedicine-hybrid group, the effectiveness for abortions conducted using telemedicine (n=18,435) was higher than for those conducted in-person (n=11,549), 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.ConclusionsMedical abortion provided through a hybrid model that includes no-test telemedicine without routine ultrasound is effective, safe, acceptable, and improves access to care.Summary BoxWhat is already known on this topicThe UK’s National Institute for Health and Care Excellence (NICE) conducted a systematic review and recommended using telemedicine to improve access to medical abortion care.Several models for using telemedicine to facilitate medical abortion have been described, but most existing trials are small, and many required attendances to have medicines administered or for an ultrasound scan or blood tests.What this study addsThis study (n=52,142) is the first to assess a real-world no-test telemedicine abortion care pathway in a national population. The new national model demonstrates how a permissive framework for medical abortion can deliver significant quality improvements to those needing to access abortion care. There was no difference in effectiveness (p=1.0) or safety (p=0.6) when compared to a traditional in-person model, but the no-test telemedicine pathway improved access to care, was highly acceptable to patients and is likely to be especially beneficial for vulnerable groups and in resource-poor settings.

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

Comparison Of Two Combination Iron Chelation Regimens, Deferiprone and Deferasirox Versus Deferiprone and Deferoxamine, In Pediatric Patients With β-Thalassemia Major

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 559-559 ◽  
Author(s):  
Mohsen Saleh Elalfy ◽  
Yasser Wali ◽  
S Tony ◽  
Ahmed Samir ◽  
Amira Adly
Keyword(s):  
Adverse Events ◽  
Iron Overload ◽  
Serum Ferritin ◽  
Cardiac Mri ◽  
Treatment Satisfaction ◽  
Short Form ◽  
Infusion Pump ◽  
Thalassemia Major ◽  
Serious Adverse Events ◽  
Patient Reported

Abstract Background Patients with severe iron overload may require a more rapid and efficient therapy for reduction in iron burden than what can be provided with chelation monotherapy. Combined chelation using deferoxamine (DFO) and deferiprone (DFP) is widely used to treat such patients, but the inconvenience of parenteral administration of DFO reduces the effectiveness of this regimen in many patients. Minimal data are available on the safety and efficacy of combined two orally active chelator agents. Aim To compare the safety, efficacy, compliance, treatment satisfaction, and quality of life (QoL) associated with two combination chelation regimens: DFP and DFO versus DFP and deferasirox (DFX). Methods This was a randomized, open-label trial registered as (NCT01511848) conducted at 2 treatment centers in patients aged 10 to 18 years with β-thalassemia major and severe iron overload (serum ferritin > 2500 μg/ L on chelation monotherapy, with 50% uptrend over the last 12 months). Patients were randomly allocated to one of two 12-month treatment regimens. All patients received DFP at a dose of 75 mg/kg/day, divided into 2 doses taken orally at 8 am and 3 pm. Those in Arm 1 additionally received DFO at a dose of 40 mg/kg/d delivered via subcutaneous infusion pump, starting at 10 pm, while those in Arm 2 additionally received a dose of DFX 20 mg/kg/d, taken orally at 10 pm. The primary efficacy endpoints were the difference between treatment groups in the change from baseline to 12 months of serum ferritin (SF) levels, liver iron concentration (LIC), and cardiac MRI. Secondary efficacy endpoints were the change from baseline to 12 months in QoL, using the Medical Outcomes Study Short Form health survey (SF-36). Serum ferritin was measured every 3 months, and liver and cardiac MRI T2* assessments were conducted every 6 months. Changes in all 3 measures were compared using 2-way ANOVA for repeated measures. The safety endpoint was the occurrence of serious adverse events during the study period. In addition, patients had complete blood count every 2 weeks, and monthly detailed clinical examinations that included blood sampling for serum creatinine, albumin/creatinine ratio, and liver function tests. Audiometric and ophthalmological assessments were conducted at baseline and 12 months. Assessments of compliance and of patient-reported outcomes (PROs) were assessed at weeks 424 and at end of study. Results A total of 96 patients were randomized. The arms were comparable with respect to baseline demographics, with a mean age of 14.9±1.8 years in Arm 1 and 15.1±1.9 years in Arm 2 (p=0.27), and with 65.2% males in Arm 1 and 66.6% males in Arm 2 (p=0.76). Forty of 46 patients (87%) in Arm 1 and 46 of 48 patients (92%) in Arm 2 completed all 12 months of treatment. Reasons for discontinuation were skin infection and pain at infusion sites in Arm 1,and decrease in SF < 1000 μg/ L in Arm 2. Efficacy findings: Table 1 shows the changes in SF, LIC, and cardiac MRI values at baseline and at completion of 1 year on therapy. Safety findings: No serious adverse events were reported during the study in either treatment group. The number of adverse effects reported was comparable in both arms. Compliance: Treatment compliance was significantly higher in Arm 2 than in Arm 1(95% vs. 80%, respectively<0.001). Satisfaction: Significantly more patients in Arm 2 than in Arm 1 reported being satisfied with treatment at both 6 months (92% vs. 64%, respectively; p<0.001) and 12 months (88% vs. 59%, respectively; p<0.001). QoL: Improvement in QoL was seen in significantly more patients in Arm 2 than in Arm 1 (85% vs. 60%, respectively; p<0.001). Conclusion Data from this randomized prospective study show that while both forms of combination therapy, DFP with DFX and DFP with DFO, were effective in reducing iron overload in multi-transfused β-thalassemia major, patients who received DFP and DFX showed a higher decline in serum ferritin, greater improvement in cardiac T2*, higher treatment satisfaction, better compliance, and more improvement in QoL than did patients who received DFP and DFO, with no increased toxicity. Disclosures: No relevant conflicts of interest to declare.

scholarly journals CRP-guided antibiotic treatment in acute exacerbations of COPD in hospital admissions

2019 ◽  
Vol 53 (5) ◽  
pp. 1802014 ◽  
Author(s):  
H.J. Prins ◽  
Ruud Duijkers ◽  
Paul van der Valk ◽  
Marianne Schoorl ◽  
Johannes M.A. Daniels ◽  
...  
Keyword(s):  
Adverse Events ◽  
Antibiotic Treatment ◽  
Hospital Admissions ◽  
Day Treatment ◽  
Controlled Trial ◽  
Chronic Obstructive Lung Disease ◽  
Chronic Obstructive ◽  
Serious Adverse Events ◽  
Patient Reported ◽  
Acute Exacerbations

The role of antibiotics in acute exacerbations of chronic obstructive pulmonary disease (COPD) is controversial and a biomarker identifying patients who benefit from antibiotics is mandatory. We performed a randomised, controlled trial in patients with acute exacerbations of COPD, comparing C-reactive protein (CRP)-guided antibiotic treatment to patient reported symptoms in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) strategy, in order to show a reduction in antibiotic prescription.Patients hospitalised with acute exacerbations of COPD were randomised to receive antibiotics based either on the GOLD strategy or according to the CRP strategy (CRP ≥50 mg·L−1).In total, 101 patients were randomised to the CRP group and 119 to the GOLD group. Fewer patients in the CRP group were treated with antibiotics compared to the GOLD group (31.7% versus 46.2%, p=0.028; adjusted odds ratio (OR) 0.178, 95% CI 0.077–0.411, p=0.029). The 30-day treatment failure rate was nearly equal (44.5% in the CRP group versus 45.5% in the GOLD-group, p=0.881; adjusted OR 1.146, 95% CI 0.649–1.187, p=0.630), as was the time to next exacerbation (32 days in the CRP group versus 28 days in the GOLD group, p=0.713; adjusted hazard ratio 0.878, 95% CI 0.649–1.187, p=0.398). Length of stay was similar in both groups (7 days in the CRP group versus 6 days in the GOLD group, p=0.206). On day-30, no difference in symptom score, quality of life or serious adverse events was detected.Use of CRP as a biomarker to guide antibiotic treatment in severe acute exacerbations of COPD leads to a significant reduction in antibiotic treatment. In the present study, no differences in adverse events between both groups were found. Further research is needed for the generalisability of these findings.

scholarly journals PDCT-07. EARLY RESULTS OF THE EMULATE THERAPEUTICS HÆLO™ SYSTEM IN PEDIATRIC BRAIN TUMORS

2019 ◽  
Vol 21 (Supplement_6) ◽  
pp. vi184-vi184
Author(s):  
Andrew Chang ◽  
Sharon Gardner ◽  
Jerry Jaboin ◽  
Sarah Leary ◽  
Rebecca Loret De Mola ◽  
...  
Keyword(s):  
Brain Tumors ◽  
Adverse Events ◽  
Pediatric Brain Tumors ◽  
Diffuse Intrinsic Pontine Glioma ◽  
Serious Adverse Events ◽  
Radio Frequency Energy ◽  
Early Results ◽  
Patient Reported ◽  
Treatment Safety ◽  
Pediatric Brain

Abstract BACKGROUND The EMulate Therapeutics Hælo system is an investigational non-sterile, non-invasive, non-thermal, non-ionizing, portable, home-use medical device that uses a specific, localized ultra-low radio frequency energy (ulRFE®) cognate for the treatment of pediatric brain tumors. METHODS Sixteen patients with brain tumors consisting of diffuse midline glioma/diffuse intrinsic pontine glioma (DMG/DIPG, n=14), recurrent medulloblastoma (n=1), or anaplastic astrocytoma (n=1) – were treated with the Hælo under FDA’s single-patient compassionate use pathway, as protocol deviations in a glioblastoma trial, or under TGA’s Special Access Scheme. Baseline information and on-treatment safety and exposure data were collected. RESULTS Patients ranged in age from 4 to 28 years (median = 8 years) and were diagnosed 91 – 1399 days (median = 397 days) prior to treatment with the Hælo system. Patients were treated for 2 – 52 weeks (median = 15 weeks), with 4 patients still alive (all with a diagnosis of DMG/DIPG), and 3 still on treatment (ranging 18 – 52 weeks). Two out of the 16 patients reported mild-moderate adverse events - one patient reported nausea, fatigue, and excessive sleepiness, and one patient reported vomiting. No device-related serious adverse events were reported. Other adverse events reported were generally associated with progressive disease. Unsolicited, anecdotal reports from some parents/caregivers noted improvements in mobility, speech, and visual acuity while on treatment. CONCLUSIONS The Hælo system appears to be safe and feasible for the treatment of pediatric brain tumors. Given that therapy is delivered non-invasively and no device-related serious adverse events were reported, further prospective study of the investigational device is warranted.

scholarly journals Ombitasvir/Paritaprevir/Ritonavir & Dasabuvir ± Ribavirin following protease inhibitors failure - A Prospective Multi-Centre Trial

2019 ◽  
Author(s):  
Liat Deutsch ◽  
Inbal Houri ◽  
Ziv Ben-Ari ◽  
Amir Shlomai ◽  
Ella Veitsman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Protease Inhibitors ◽  
First Generation ◽  
Genotype 1 ◽  
Open Label ◽  
Serious Adverse Events ◽  
Hcv Genotype ◽  
Patient Reported ◽  
Hcv Genotype 1

Abstract Background: Hepatitis C virus (HCV) infection is a leading cause of chronic liver disease and hepatocellular carcinoma. Treatment with first generation protease inhibitors (PI)+peg-interferon (pegIFN) and ribavirin (RBV) achieved sustained virologic response (SVR) rates of 65-75% but was associated with multiple side effects. The aim of this study was to evaluate safety and efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir (3D)±RBV in HCV genotype 1 patients that failed previous treatment with first generation PIs. Methods: An investigator-initiated, open-label, multi-centre clinical trial. HCV Genotype 1 patients who were previously null/partial responders or relapsers to telaprevir, boceprevir or simepravir+pegIFN/RBV and met eligibility criteria were included. 3D±RBV were administrated for 12 or 24 weeks according to label. The primary outcome was antiviral response (SVR12); Secondary outcomes were patient reported outcomes, adverse events and resistance associated variants. Results: Thirty-nine patients initiated treatment according to study protocol (59% men, age 54.0±8.7 years, BMI 28.7±4.5 kg/m2). Thirty-seven (94.9%) completed the study. Thirty-five patients had genotype 1b (9 cirrhotics) and 4 had genotype 1a (2 cirrhotics). Intention-to-treat SVR12 was 92.3% and per-protocol SVR12 was 97.3%. The rate of advanced fibrosis (FibroScan® score F3-4) declined from 46.2% to 25.7% (P=0.045). Abnormal ALT levels declined from 84.6% to 8.6% (P<0.001). Seven patients (17.9%) experienced serious adverse events (3 Psychiatric admissions, 1 pneumonia, 1 ankle fracture, 2 palpitations), and 12 patients (30.8%) experienced self-reported adverse events, mostly weakness. Conclusion: 3D±RBV is safe and effective in achieving SVR among patients with HCV genotype 1 who failed previous first-generation PI treatment. Clinical trial number: NCT02646111

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