Crowdsourcing sugammadex adverse event rates using an in-app survey: feasibility assessment from an observational study.
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ABSTRACT: Background
Mobile applications (apps) have become a ubiquitous source of clinical decision support. We sought to ascertain the feasibility of using an app platform to obtain a crowdsourced measure of adverse drug reaction reporting rates associated with sugammadex administration and compare it with traditionally-derived estimates.Methods
Using the widely-distributed anesthesia calculator app, 'Anesthesiologist', we surveyed anesthesia providers regarding their experience with adverse drug reactions associated with sugammadex administration.Results
Data were analyzed from 2770 participants in 119 countries responding between March 2016 and May 2017, who were estimated to have administered between 1.6-2.9 million doses (588-1040 administrations per participant). A low and high-end reporting rate of adverse events was estimated based on respondents' reported frequency and duration of sugammadex use. The estimated reporting rate of anaphylaxis due to sugammadex was 0.0055-0.098%, similar in range to previously published estimates.Conclusions
Use of an in-app survey facilitated a global assessment of anesthesia providers and could have useful applications in monitoring adverse events and estimating their rates. Further work is needed to validate this approach for other medications and clinical domains.
SUBMITTER: Jabaley CS
PROVIDER: S-EPMC6048631 | biostudies-literature | 2018 Jul
REPOSITORIES: biostudies-literature
Publications
Crowdsourcing sugammadex adverse event rates using an in-app survey: feasibility assessment from an observational study.
Jabaley Craig S CS Wolf Francis A FA Lynde Grant C GC O'Reilly-Shah Vikas N VN
Therapeutic advances in drug safety 20180418 7
<h4>Background</h4>Mobile applications (apps) have become a ubiquitous source of clinical decision support. We sought to ascertain the feasibility of using an app platform to obtain a crowdsourced measure of adverse drug reaction reporting rates associated with sugammadex administration and compare it with traditionally-derived estimates.<h4>Methods</h4>Using the widely-distributed anesthesia calculator app, 'Anesthesiologist', we surveyed anesthesia providers regarding their experience with adv ...[more]
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Project description:ImportancePatient safety is a US national priority, yet lacks a comprehensive assessment of progress over the past decade.ObjectiveTo determine the change in the rate of adverse events in hospitalized patients.Design, setting, and participantsThis serial cross-sectional study used data from the Medicare Patient Safety Monitoring System from 2010 to 2019 to assess in-hospital adverse events in patients. The study included 244 542 adult patients hospitalized in 3156 US acute care hospitals across 4 condition groups from 2010 through 2019: acute myocardial infarction (17%), heart failure (17%), pneumonia (21%), and major surgical procedures (22%); and patients hospitalized from 2012 through 2019 for all other conditions (22%).ExposuresAdults aged 18 years or older hospitalized during each included calendar year.Main outcomes and measuresInformation on adverse events (abstracted from medical records) included 21 measures across 4 adverse event domains: adverse drug events, hospital-acquired infections, adverse events after a procedure, and general adverse events (hospital-acquired pressure ulcers and falls). The outcomes were the total change over time for the observed and risk-adjusted adverse event rates in the subpopulations.ResultsThe study sample included 190 286 hospital discharges combined in the 4 condition-based groups of acute myocardial infarction, heart failure, pneumonia, and major surgical procedures (mean age, 68.0 [SD, 15.9] years; 52.6% were female) and 54 256 hospital discharges for the group including all other conditions (mean age, 57.7 [SD, 20.7] years; 59.8% were female) from 3156 acute care hospitals across the US. From 2010 to 2019, the total change was from 218 to 139 adverse events per 1000 discharges for acute myocardial infarction, from 168 to 116 adverse events per 1000 discharges for heart failure, from 195 to 119 adverse events per 1000 discharges for pneumonia, and from 204 to 130 adverse events per 1000 discharges for major surgical procedures. From 2012 to 2019, the rate of adverse events for all other conditions remained unchanged at 70 adverse events per 1000 discharges. After adjustment for patient and hospital characteristics, the annual change represented by relative risk in all adverse events per 1000 discharges was 0.94 (95% CI, 0.93-0.94) for acute myocardial infarction, 0.95 (95% CI, 0.94-0.96) for heart failure, 0.94 (95% CI, 0.93-0.95) for pneumonia, 0.93 (95% CI, 0.92-0.94) for major surgical procedures, and 0.97 (95% CI, 0.96-0.99) for all other conditions. The risk-adjusted adverse event rates declined significantly in all patient groups for adverse drug events, hospital-acquired infections, and general adverse events. For patients in the major surgical procedures group, the risk-adjusted rates of events after a procedure declined significantly.Conclusions and relevanceIn the US between 2010 and 2019, there was a significant decrease in the rates of adverse events abstracted from medical records for patients admitted for acute myocardial infarction, heart failure, pneumonia, and major surgical procedures and there was a significant decrease in the adjusted rates of adverse events between 2012 and 2019 for all other conditions. Further research is needed to understand the extent to which these trends represent a change in patient safety.
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Project description:IntroductionThe under-reporting of adverse drug events (ADEs) is an international health concern. A number of studies have assessed the root causes but, to our knowledge, little information exists relating under-reporting to practices and systems used for the recording and tracking of drug-related adverse event observations in ambulatory settings, institutional settings, and retail pharmacies.ObjectivesOur objective was to explore the process for reporting ADEs in US hospitals, ambulatory settings, and retail pharmacies; to explore gaps and inconsistencies in the reporting process; and to identify the causes of under-reporting ADEs in these settings.MethodsThe Tufts Center for the Study of Drug Development (Tufts CSDD) interviewed 11 thought leaders and conducted a survey between May and August 2014 among US-based healthcare providers (HCPs) in diverse settings to assess their experiences with, and processes for, reporting ADEs.ResultsA total of 123 individuals completed the survey (42 % were pharmacists; 27 % were nurses; 15 % were physicians; and 16 % were classified as 'other'). HCPs indicated that the main reasons for under-reporting were difficulty in determining the cause of the ADE, given that most patients receive multiple therapies simultaneously (66 % of respondents); that HCPs lack sufficient time to report ADEs (63 % of respondents); poor integration of ADE-reporting systems (53 % of respondents); and uncertainty about reporting procedures (52 % of respondents).DiscussionThe results of this pilot study identify that key factors contributing to the under-reporting of ADEs relate to a lack of standardized process, a lack of training and education, and a lack of integrated health information technologies.
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Project description:IntroductionCrowdsourcing is an emerging technique to engage or access a wider set of experts and multiple stakeholders through online platforms, which might effectively be employed in waste management. Therefore, we assessed the feasibility of the crowdsourcing method to provide an alternative approach that can improve household waste segregation using an "online-slogan-contest".MethodsThe contest was promoted via targeted emails to various governmental and non-governmental organizations and through social media platforms for around 4 weeks (25 days). The entries were received through a Google form. The slogans were assessed by the experts and analyzed using content analysis methods.ResultsTotal 969 entries were received from different geographic regions in India. Of that, 456 were in English and 513 in Hindi. Five themes of waste segregation emerged from the received slogans: (1) Community awareness, responsibility, and support, (2) Significance of household waste segregation, (3) Use of separate dustbins, (4) Health and well-being, and (5) Environment and sustainability.DiscussionCrowdsourcing approaches can be used by local authorities for improving waste management approaches and are recommended as these involve a wider audience within a short time frame. Moreover, this approach is flexible and integrating crowdsourcing approaches strengthens our understanding of existing waste management activities.
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Project description:BackgroundHeart rate (HR) assessment is crucial in neonatal resuscitation, but pulse oximetry (PO) and electrocardiography (ECG) are rarely accessible in low-resource to middle-resource settings. This study evaluated a free-of-charge smartphone application, NeoTap, which records HR with a screen-tapping method bypassing mental arithmetic calculations.MethodsThis observational study was carried out during three time periods between May 2015 and January 2019 in Uganda in three phases. In phase 1, a metronome rate (n=180) was recorded by low-end users (midwives) using NeoTap. In phase 2, HR (n=69) in breathing neonates was recorded by high-end users (paediatricians) using NeoTap versus PO. In phase 3, HR (n=235) in non-breathing neonates was recorded by low-end users using NeoTap versus ECG.ResultsIn high-end users the mean difference was 3 beats per minute (bpm) higher with NeoTap versus PO (95% agreement limits -14 to 19 bpm), with acquisition time of 5 seconds. In low-end users, the mean difference was 6 bpm lower with NeoTap versus metronome (95% agreement limits -26 to 14 bpm) and 3 bpm higher with NeoTap versus ECG in non-breathing neonates (95% agreement limits -48 to 53 bpm), with acquisition time of 2.7 seconds. The agreement between NeoTap and ECG was good in the HR categories of 60-99 bpm and ≥100 bpm; HR <60 bpm had few measurements (kappa index 0.71, 95% CI 0.63 to 0.79).ConclusionHR could be accurately and rapidly assessed using a smartphone application in breathing neonates in a low-resource setting. Clinical assessment by low-end users was less accurate with wider CI but still adds clinically important information in non-breathing neonates. The authors suggest low-end users may benefit from auscultation-focused training. More research is needed to evaluate its feasibility in clinical use.
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Project description:BackgroundBy enabling frequent, sensitive, and economic remote assessment, smartphones will facilitate the detection of early cognitive decline at scale. Previous studies have sustained participant engagement with remote cognitive assessment over a week; extending this to a period of 1 month clearly provides a greater opportunity for measurement. However, as study durations are increased, the need to understand how participant burden and scientific value might be optimally balanced also increases.ObjectiveThis study explored the little but often approach to assessment employed by the Mezurio app when prompting participants to interact every day for over a month. Specifically, this study aimed to understand whether this extended duration of remote study is feasible, and which factors promote sustained participant engagement over such periods.MethodsA total of 35 adults (aged 40-59 years) with no diagnosis of cognitive impairment were prompted to interact with the Mezurio smartphone app platform for up to 36 days, completing short, daily episodic memory tasks in addition to optional executive function and language tests. A subset (n=20) of participants completed semistructured interviews focused on their experience of using the app.ResultsParticipants complied with 80% of the daily learning tasks scheduled for subsequent tests of episodic memory, with 88% of participants still actively engaged by the final task. A thematic analysis of the participants' experiences highlighted schedule flexibility, a clear user interface, and performance feedback as important considerations for engagement with remote digital assessment.ConclusionsDespite the extended study duration, participants demonstrated high compliance with the schedule of daily learning tasks and were extremely positive about their experiences. Long durations of remote digital interaction are therefore definitely feasible but only when careful attention is paid to the design of the users' experience.
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Project description:ObjectiveTo provide clinicians and patients with accurate risk estimates of serious adverse events after common elective shoulder arthroscopic procedures, including reoperation within one year.DesignPopulation based cohort study.SettingHospital Episode Statistics for NHS England, including civil registration mortality data from the Office for National Statistics.Participants288 250 arthroscopic shoulder procedures performed in 261 248 patients aged ≥16 years between 1 April 2009 and 31 March 2017. Elective procedures were grouped into subacromial decompression, rotator cuff repair, acromioclavicular joint excision, glenohumeral stabilisation, and frozen shoulder release.Main outcome measuresThe primary outcomes were rates of serious adverse events (mortality, pulmonary embolism, pneumonia, myocardial infarction, acute kidney injury, stroke, and urinary tract infection) requiring inpatient care within 90 days post-surgery. Secondary outcomes were specific adverse event rates at 90 days, and reoperations (including for deep infection) within one year.ResultsThe overall rate of complications within 90 days after arthroscopic shoulder surgery (including reoperation) was low at 1.2% (95% confidence interval 1.2% to 1.3%), with one in 81 patients at risk, and varied according to type of procedure, from 0.6% (0.5% to 0.8%) for glenohumeral stabilisation to 1.7% (1.5% to 1.8%) for frozen shoulder release. After adjustment for age, comorbidities, and sex, no effect of procedure type was observed. Pneumonia was the most common adverse event (0.3%, 0.3% to 0.4%), with one in 303 patients at risk. Pulmonary embolic events were rare, at 0.1% (0.1% to 0.1%), with one in 1428 patients at risk. At one year, the overall rate for reoperation was 3.8% (3.8% to 3.9%), with one in 26 patients at risk, ranging from 2.7% (2.5% to 3.0%) for glenohumeral stabilisation to 5.7% (5.4% to 6.1%) for frozen shoulder release. The overall rate of further surgery for deep infection was low, at 0.1% (0.1% to 0.1%), with one in 1111 patients at risk, but was higher after rotator cuff repair (0.2%, 0.2% to 0.2%), with one in 526 patients at risk. Over the study period the number of arthroscopic shoulder procedures increased, except for subacromial decompression, which decreased.ConclusionsThe findings of this study suggest that risks of serious adverse events associated with common shoulder arthroscopy procedures are low. Nevertheless, serious complications do occur, and include the risk of reoperation in one in 26 patients within one year.Study registrationClinical.Trialsgov NCT03573765.
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Project description:OBJECTIVE:Real-world data (RWD) are increasingly used for pharmacoepidemiology and regulatory innovation. Our objective was to compare adverse drug event (ADE) rates determined from two RWD sources, electronic health records and administrative claims data, among children treated with drugs for pulmonary hypertension. MATERIALS AND METHODS:Textual mentions of medications and signs/symptoms that may represent ADEs were identified in clinical notes using natural language processing. Diagnostic codes for the same signs/symptoms were identified in our electronic data warehouse for the patients with textual evidence of taking pulmonary hypertension-targeted drugs. We compared rates of ADEs identified in clinical notes to those identified from diagnostic code data. In addition, we compared putative ADE rates from clinical notes to those from a healthcare claims dataset from a large, national insurer. RESULTS:Analysis of clinical notes identified up to 7-fold higher ADE rates than those ascertained from diagnostic codes. However, certain ADEs (eg, hearing loss) were more often identified in diagnostic code data. Similar results were found when ADE rates ascertained from clinical notes and national claims data were compared. DISCUSSION:While administrative claims and clinical notes are both increasingly used for RWD-based pharmacovigilance, ADE rates substantially differ depending on data source. CONCLUSION:Pharmacovigilance based on RWD may lead to discrepant results depending on the data source analyzed. Further work is needed to confirm the validity of identified ADEs, to distinguish them from disease effects, and to understand tradeoffs in sensitivity and specificity between data sources.
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Project description:BackgroundRepresentativeness of antihypertensive drug trials is uncertain, as many trials recruit few or no older people. Some trials specifically recruit older participants to address this. Here, we assess the representativeness of trials focusing on older people by comparing the rates of serious adverse events in these trials with the rates in trials of a general adult population (ie, standard trials), and comparing these findings to the rate of hospitalisations and deaths in people with hypertension starting a similar treatment in routine clinical practice.MethodsFor this observational study, we identified randomised controlled trials (phase 2/3, 3, or 4) of renin-angiotensin-aldosterone system (RAAS) drugs for hypertension registered from 1999 onwards with ClinicalTrials.gov. Serious adverse events are routinely included in trial reports and are predominantly accounted for by all-cause hospitalisations and deaths. We compared serious adverse event rates in older-people trials (minimum inclusion age ≥60 years) and standard trials (minimum inclusion age <60 years) using Poisson regression models adjusted for trial characteristics (drug type, comparison type, phase, and outcome type). We identified a community cohort of 56 036 adults with hypertension commencing similar drugs to obtain an expected rate of emergency or urgent hospitalisations or deaths, and compared this rate to observed serious adverse event rates in each trial, adjusted for age and sex. For standard trials and for older-people trials, we calculated the standardised ratio of the expected to the observed rate of serious adverse events using Poisson regression models.FindingsWe included 110 trials, of which 11 (10%) were older-people trials and 99 (90%) were standard trials. Older-people trials had a higher rate of serious adverse events than did standard trials (median events per person per year 0·18 [IQR 0·12-0·29] vs 0·11 [0·08-0·18]; adjusted incidence rate ratio 1·76 [95% CI 1·01-3·03]). The hospitalisation and death rate in the community for those taking RAAS antihypertensives was much greater than the rate of serious adverse events reported in standard trials (standardised ratio [SR] 4·23, 95% CI 3·51-5·09) and older-people trials (4·76, 2·89-7·86), adjusting for age and sex. The magnitude of risk increase for serious adverse events in community patients taking RAAS did not differ when comparing older-people and standard trials (ratio of SRs 1·13, 95% CI 0·66-1·92).InterpretationTrials report substantially fewer serious adverse events than expected from rates of hospitalisations and deaths among similar-aged people receiving equivalent treatments in the community. Serious adverse event rates might be a useful metric to assess trial representativeness. Clinicians should be cautious when applying trial recommendations to older people, even when trials focus on older participants.FundingWellcome Trust, Medical Research Council.
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