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Veterans Health Administration response to 2021 recall of Philips Respironics devices: A case study.Frontiers in Sleep Apr 2023This case study describes, for the time frame of June 2021 through August 2022, the U.S. Veterans Health Administration (VHA) organizational response to a manufacturer's...
This case study describes, for the time frame of June 2021 through August 2022, the U.S. Veterans Health Administration (VHA) organizational response to a manufacturer's recall of positive airway pressure devices used in the treatment of sleep disordered breathing. VHA estimated it could take over a year for Veterans to receive replacement devices. Veterans awaiting a replacement faced a dilemma. They could continue using the recalled devices and bear the product safety risks that led to the recall, or they could stop using them and bear the risks of untreated sleep disordered breathing. Using a program monitoring approach, we report on the processes VHA put in place to respond to the recall. Specifically, we report on the strategic, service, and operational plans associated with VHA's response to the recall for Veterans needing replacement devices. In program monitoring, the strategic plan reflects the internal process objectives for the program. The service plan articulates how the delivery of services will intersect the customer journey. The operational plan describes how the program's resources and actions must support the service delivery plan. VHA's strategic plan featured a clinician-led, as opposed to primarily legal or administrative response to the recall. The recall response team also engaged with VHA's medical ethics service to articulate an ethical framework guiding the allocation of replacement devices under conditions of scarcity. This framework proposed allocating scarce devices to Veterans according to their clinical need. The service plan invited Veterans to schedule visits with sleep providers who could assess their clinical need and counsel them accordingly. The operational plan distributed devices according to clinical need as they became available. Monitoring our program processes in real time helped VHA launch and adapt its response to a recall affecting more than 700,000 Veterans.
PubMed: 38585370
DOI: 10.3389/frsle.2023.1129415 -
Canada Communicable Disease Report =... Aug 2023is a non-fermenting, gram-negative bacteria that has previously been implicated in multiple nosocomial outbreaks through the use of contaminated medical devices and...
BACKGROUND
is a non-fermenting, gram-negative bacteria that has previously been implicated in multiple nosocomial outbreaks through the use of contaminated medical devices and substances. This article reports on an outbreak of infections and colonizations, involving 11 patients from five acute care hospitals in Montréal, Canada.
METHODS
One sample was not available for testing, but the remaining 10 isolates (91%) were sent for phylogenetic testing. Medical materials and the patients' environments were also sampled and cultured. Samples were tested using pulsed field gel electrophoresis and multilocus sequence typing.
RESULTS
The outbreak was found to be associated with the use of intrinsically contaminated non-sterile ultrasound gel. Relatedness of the gel's and the patients' strains was demonstrated using gel electrophoresis and multilocus sequence typing analyses. The investigation was concluded with a prompt recall of the product, and the outbreak was declared over by the end of October 2021.
CONCLUSION
Contaminated non-sterile gel caused infections and pseudo-infections in several patients.
PubMed: 38455880
DOI: 10.14745/ccdr.v49i78a03 -
PeerJ. Computer Science 2024Opinion mining is gaining significant research interest, as it directly and indirectly provides a better avenue for understanding customers, their sentiments toward a...
Opinion mining is gaining significant research interest, as it directly and indirectly provides a better avenue for understanding customers, their sentiments toward a service or product, and their purchasing decisions. However, extracting every opinion feature from unstructured customer review documents is challenging, especially since these reviews are often written in native languages and contain grammatical and spelling errors. Moreover, existing pattern rules frequently exclude features and opinion words that are not strictly nouns or adjectives. Thus, selecting suitable features when analyzing customer reviews is the key to uncovering their actual expectations. This study aims to enhance the performance of explicit feature extraction from product review documents. To achieve this, an approach that employs sequential pattern rules is proposed to identify and extract features with associated opinions. The improved pattern rules total 41, including 16 new rules introduced in this study and 25 existing pattern rules from previous research. An average calculated from the testing results of five datasets showed that the incorporation of this study's 16 new rules significantly improved feature extraction precision by 6%, recall by 6% and F-measure value by 5% compared to the contemporary approach. The new set of rules has proven to be effective in extracting features that were previously overlooked, thus achieving its objective of addressing gaps in existing rules. Therefore, this study has successfully enhanced feature extraction results, yielding an average precision of 0.91, an average recall value of 0.88, and an average F-measure of 0.89.
PubMed: 38435547
DOI: 10.7717/peerj-cs.1821 -
PloS One 2024The results of a survey of 1,071 adults in the United States reveal that most consumers do not pay attention to, let alone understand, arbitration clauses in their...
The results of a survey of 1,071 adults in the United States reveal that most consumers do not pay attention to, let alone understand, arbitration clauses in their everyday lives. The vast majority of survey respondents (over 97%) report having opened an account with a company that requires disputes to be submitted to binding arbitration (e.g., Netflix, Hulu, Cash App, a phone or cable company), yet most are unaware that they have, in fact, agreed to mandatory arbitration (also known as "forced arbitration"). Indeed, over 99% of respondents who think they have never entered into an arbitration agreement likely have done so. Over 92% of respondents report that they have never based a decision to use a product or service on whether the terms and conditions contain an arbitration agreement. When prompted, they largely endorse the following reasons: they were unaware of the arbitration clause, they did not read the terms and conditions, and they thought they had no choice but to agree to mandatory arbitration. Moreover, many respondents presume that if a dispute arises, they will still be able to access the public courts, notwithstanding that they agreed to the terms and conditions. Consumers are largely unaware of opportunities to opt out of mandatory arbitration. They generally do not pay attention to or retain information about the steps required to opt out successfully (e.g., contacting the company within a specified time period). Generally, consumers are unaware that companies like Cash App and Venmo (mobile payment systems utilized by nearly 60% of respondents) allow customers to opt out of mandatory arbitration if they act within a limited time period. Among the minority of respondents (21%) who stated that they had been given an opportunity to opt out, vanishingly few could name any of the steps required to opt out successfully. When presented with a run-of-the-mill contract, of the type consumers routinely encounter, most respondents did not take notice of the arbitration clause. Less than 5% of respondents could recall that the contract they were shown had said anything at all about arbitration. Furthermore, most consumers misperceive the consequences of signing a predispute arbitration agreement. Most mistakenly believe that, after agreeing to terms and conditions mandating binding arbitration, they can still choose to settle their dispute in court, have a jury decide their case, join a class action, and appeal a decision made based on a legal error. For instance, less than 5% of respondents correctly reported that they could neither appeal an erroneous decision to another arbitrator (or set of arbitrators) nor start all over again in court. Less than 1% of respondents correctly understood the full significance of the arbitration agreement, as indicated by their responses to questions about whether they retained the rights to sue, have a jury decide their case, access the public courts, and appeal a decision based on a legal error. In summary, consumers are generally unaware of arbitration clauses, and they tend to hold mistaken beliefs about how arbitration agreements affect consumers' procedural rights.
Topics: United States; Negotiating; Contracts; Dissent and Disputes
PubMed: 38394135
DOI: 10.1371/journal.pone.0296179 -
Women's Health (London, England) 2024Adolescent girls face numerous challenges which hinder their ability to manage menstruation in a healthy and dignified manner.
BACKGROUND
Adolescent girls face numerous challenges which hinder their ability to manage menstruation in a healthy and dignified manner.
OBJECTIVES
To examine the menstrual hygiene practices of adolescent girls schooling in rural Anambra communities.
STUDY DESIGN
Cross-sectional descriptive study.
METHOD
Participants were selected using multistage stratified random sampling technique and interviewed using self-administered semi-structured questionnaire. Data were analysed using Statistical Package for Social Sciences version 22.0.
RESULTS
Mean age of all, pre-menarche and post-menarche girls were 14.7 ± 1.84, 12.8 ± 1.09 and 15.1 ± 1.73 years, respectively. About 46% of the pre-menarche girls had not received any information on menstruation. Common sources of initial menstruation information were mother (87.3%), school (52.2%) and peers (20.0%). Among the 1091 (85.0% (1091/1283)) post-menarche girls, last menstrual period, last menstrual period duration and cycle length could not be recalled by 53.9%, 34.4% and 39.3%, respectively. Majority (98.3%) who could recall last menstrual period had a cycle length of ⩽30 days and the mean duration of menses was 4.4 ± 0.84 days. Disposable sanitary pad was mostly (60%) cited as recommended product, but cloth/rags (40.6%) or tissue paper (32. 3%) were predominantly used. Majority (88.6%) took their bath ⩾twice/day, 50.9% changed sanitary product ⩽twice/day while 72.5% exhibited poor hand washing. Sanitary products were mostly discarded by burning (45.4%). Fifty-one percent could not change in school predominantly due to lack of functional toilets/changing rooms (84.2%) while 72.5% of those who changed did so in bushes or unused spaces. Challenges faced during menstruation include restriction from holy places (38.9%), waist pain (74.9%), blood stains (36.1%) and lack of money to buy pad (27.0%). Factors significantly associated with using commercial pads were age (p = 0.047), class (p = 0.006), mother's educational status (p < 0.001), social class (p < 0.001), ability to recall last menstrual period date (p = 0.029) or duration (p = 0.001).
CONCLUSION
Menstrual hygiene management was unsatisfactory among studied adolescents. Continuous education of adolescent girls on menstrual hygiene management and advocacy for adequate menstrual hygiene management support are imperative.
Topics: Female; Adolescent; Humans; Menstruation; Hygiene; Cross-Sectional Studies; Health Knowledge, Attitudes, Practice; Schools
PubMed: 38318680
DOI: 10.1177/17455057241228204 -
JMIR Formative Research Feb 2024The prevalence of childhood obesity and comorbidities is rising alarmingly, and diet is an important modifiable determinant. Numerous dietary interventions in children...
BACKGROUND
The prevalence of childhood obesity and comorbidities is rising alarmingly, and diet is an important modifiable determinant. Numerous dietary interventions in children have been developed to reduce childhood obesity and overweight rates, but their long-term effects are unsatisfactory. Stakeholders call for more personalized approaches, which require detailed dietary intake data. In the case of primary school children, caregivers are key to providing such dietary information. However, as school-aged children are not under the full supervision of one specific caregiver anymore, data are likely to be biased. Recent technological advancements provide opportunities for the role of children themselves, which would serve the overall quality of the obtained dietary data.
OBJECTIVE
This study aims to conduct a child-centered exploratory sequential mixed methods study to identify user requirements for a dietary assessment tool for children aged 5 to 6 years.
METHODS
Formative, nonsystematic narrative literature research was undertaken to delineate initial user requirements and inform prototype ideation in an expert panel workshop (n=11). This yielded 3 prototype dietary assessment tools: FoodBear (tangible piggy bank), myBear (smartphone or tablet app), and FoodCam (physical camera). All 3 prototypes were tested for usability by means of a usability task (video analyses) and user experience (This or That method) among 14 Dutch children aged 5 to 6 years (n=8, 57% boys and n=6, 43% girls).
RESULTS
Most children were able to complete FoodBear's (11/14, 79%), myBear's (10/14, 71%), and FoodCam's (9/14, 64%) usability tasks, but all children required assistance (14/14, 100%) and most of the children encountered usability problems (13/14, 93%). Usability issues were related to food group categorization and recognition, frustrations owing to unsatisfactory functioning of (parts) of the prototypes, recall of food products, and the distinction between eating moments. No short-term differences in product preference between the 3 prototypes were observed, but autonomy, challenge, gaming elements, being tablet based, appearance, social elements, and time frame were identified as determinants of liking the product.
CONCLUSIONS
Our results suggest that children can play a complementary role in dietary data collection to enhance the data collected by their parents. Incorporation of a training program, auditory or visual prompts, reminders and feedback, a user-friendly and intuitive interaction design, child-friendly food groups or icons, and room for children's autonomy were identified as requirements for the future development of a novel and usable dietary assessment tool for children aged 5 to 6 years. Our findings can serve as valuable guidance for ongoing innovations in the field of children's dietary assessment and the provision of personalized dietary support.
PubMed: 38300689
DOI: 10.2196/47850 -
Pharmaceutical Medicine Mar 2024Cyproterone acetate (CPA) is a synthetic progesterone derivative introduced in the 1970s and prescribed as antiandrogenic therapy for inoperable prostate cancer, sexual...
BACKGROUND
Cyproterone acetate (CPA) is a synthetic progesterone derivative introduced in the 1970s and prescribed as antiandrogenic therapy for inoperable prostate cancer, sexual deviations in men, and signs of androgenization in women. In 2020, the CPA summary of product characteristics (SmPC) was revised to include an updated special warning and precaution about (1) the risk of meningioma with increasing cumulative dose and (2) contraindication in patients with meningioma or history of meningioma. A Direct Healthcare Professional Communication (DHPC) was distributed. The European Medicine Agency's Pharmacovigilance Risk Assessment Committee requested that marketing authorization holders in Europe conduct a survey to assess physicians' knowledge of the updated key safety information. The primary objective of this study was to measure physicians' awareness (i.e., did they receive and review the revised SmPC and DHPC) and level of knowledge and understanding of the key safety information pertaining to the restricted use of CPA monotherapy because of the risk of meningioma.
METHODS
This cross-sectional web-based survey was administered to dermatologists, endocrinologists, gynecologists, urologists, oncologists, psychiatrists, and general practitioners in France, Germany, Poland, Spain, and the Netherlands who had prescribed CPA monotherapy in the previous 12 months to assess awareness of the risk of meningioma associated with CPA monotherapy.
RESULTS
Of the 613 physicians who participated, 85% correctly indicated that CPA monotherapy should be prescribed with the lowest effective dose, 75% correctly indicated that the risk of meningioma increases with increasing cumulative CPA monotherapy doses, and 73% correctly indicated that treatment with CPA-containing products must be stopped permanently if a patient is diagnosed with meningioma. Overall, 40% of physicians reported having received the DHPC, and 42% reported having received the revised SmPC.
CONCLUSIONS
Despite low recall of receipt of the updated SmPC and DHPC, most physicians surveyed are aware of the meningioma risk and actions to mitigate the risk.
Topics: Male; Humans; Female; Cyproterone Acetate; Meningioma; Cross-Sectional Studies; Europe; Physicians; Meningeal Neoplasms; Phospholipid Ethers
PubMed: 38296916
DOI: 10.1007/s40290-023-00510-x -
JAMA Network Open Jan 2024Kratom products, which are sold legally in most of the US, contain alkaloids with opioidergic, adrenergic, and serotonergic activity. Millions of people use kratom to...
IMPORTANCE
Kratom products, which are sold legally in most of the US, contain alkaloids with opioidergic, adrenergic, and serotonergic activity. Millions of people use kratom to relieve pain, improve mood, or self-manage substance use disorders (SUDs). Kratom use has primarily been examined via surveys, in which recall biases among satisfied users may lead to minimization of transient negative outcomes. Further prospective study of kratom use, such as with ecological momentary assessment (EMA), is needed.
OBJECTIVE
To characterize proximal motivators, effects, and patterns of kratom use and to assess whether use frequency is associated with motivations, effects, past-year criteria for SUD for kratom (KUD), or other substance use.
DESIGN, SETTING, AND PARTICIPANTS
For this prospective cross-sectional study, an intensive longitudinal smartphone-based EMA in which participants' current behaviors and experiences were repeatedly sampled in real time was conducted between July 1 and October 31, 2022. Participants comprised a convenience sample of US adults who used kratom at least 3 days per week for at least 4 weeks at the time of online screening. Criteria for past-year KUD were based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Data analysis was performed between November 2022 and November 2023.
EXPOSURE
The exposure was 13 401 kratom-use events across 15 days.
MAIN OUTCOMES AND MEASURES
A baseline survey covering demographics, health, kratom attitudes and behaviors, use motivations, other substance use, and KUD was administered before EMA. Data for the following EMA entries were then collected: event-contingent entries for kratom use (product, dose, and proximal motivations), follow-up entries (short-term effects and consequences of use events), random-prompt entries (mood), beginning-of-day entries (effects of kratom on sleep), and end-of-day entries (daily subjective descriptions of kratom effects). Bayesian regression was used to estimate means and credible intervals.
RESULTS
A total of 357 participants completed the EMA. Their mean (SD) age was 38.0 (11.1) years; more than half were men (198 [55.5%]). Participants reported overall motivators of use on the baseline survey that involved managing psychiatric and SUD problems, but proximal motivators evaluated during the EMA involved situation-specific needs such as increasing energy and productivity and decreasing pain. Acute effects were considered congruent with daily obligations. Use patterns, despite having some distinguishing features, were generally similar in their motivators and effects; participants used kratom predominantly during the daytime and seemed to find use frequencies that suited their needs. Higher use patterns were associated with symptoms of physical dependence (eg, withdrawal or tolerance). Co-used substances included caffeine, nicotine, vitamins, and cannabis.
CONCLUSIONS AND RELEVANCE
Most participants in this study reported using kratom in a seemingly nonproblematic way. When such use appeared problematic, the key element was usually that withdrawal avoidance became a proximal motivator. Longitudinal studies examining changes in kratom use patterns and effects over time are needed.
Topics: Adult; Female; Humans; Male; Bayes Theorem; Cross-Sectional Studies; Ecological Momentary Assessment; Mitragyna; Motivation; Pain; Prospective Studies; Self Report; Substance-Related Disorders; Middle Aged
PubMed: 38277146
DOI: 10.1001/jamanetworkopen.2023.53401 -
Sensors (Basel, Switzerland) Jan 2024Transactional data from point-of-sales systems may not consider customer behavior before purchasing decisions are finalized. A smart shelf system would be able to...
Transactional data from point-of-sales systems may not consider customer behavior before purchasing decisions are finalized. A smart shelf system would be able to provide additional data for retail analytics. In previous works, the conventional approach has involved customers standing directly in front of products on a shelf. Data from instances where customers deviated from this convention, referred to as "cross-location", were typically omitted. However, recognizing instances of cross-location is crucial when contextualizing multi-person and multi-product tracking for real-world scenarios. The monitoring of product association with customer keypoints through RANSAC modeling and particle filtering (PACK-RMPF) is a system that addresses cross-location, consisting of twelve load cell pairs for product tracking and a single camera for customer tracking. In this study, the time series vision data underwent further processing with R-CNN and StrongSORT. An NTP server enabled the synchronization of timestamps between the weight and vision subsystems. Multiple particle filtering predicted the trajectory of each customer's centroid and wrist keypoints relative to the location of each product. RANSAC modeling was implemented on the particles to associate a customer with each event. Comparing system-generated customer-product interaction history with the shopping lists given to each participant, the system had a general average recall rate of 76.33% and 79% for cross-location instances over five runs.
Topics: Humans; Supermarkets; Commerce; Research Personnel; Sprains and Strains; Standing Position
PubMed: 38257460
DOI: 10.3390/s24020367 -
Pharmaceuticals (Basel, Switzerland) Dec 2023Levothyroxine tablets, although highly prescribed in the United States, have been one of the most frequently recalled products. Because of the importance of the...
Levothyroxine tablets, although highly prescribed in the United States, have been one of the most frequently recalled products. Because of the importance of the medication, several efforts have been put in place by the United States Food and Drug Administration (US FDA) to control the quality of levothyroxine tablets available to patients using the drug. The choice of excipients used in the formulation has been shown to impact the hygroscopicity and microenvironment, and ultimately the stability of the levothyroxine tablets formulations. Based on information generated from the US FDA Enforcement Report database, one of the main reasons for recalls is the low potency of different batches of the product. The yearly product recall trends for levothyroxine formulations were determined using the FDA Enforcement Report database. Three brands of levothyroxine tablets were selected with excipient lists similar to those products that have been historically recalled. The samples were placed at ambient (~23 °C), accelerated stability (40 °C/75% RH), and stress (50 °C/75% RH) conditions for up to 6 months. Sample potencies were determined at 0, 1.5, 3, and 6 months using the methods for assay and impurities in the United States Pharmacopeia (USP) monograph for levothyroxine tablets. Additional sample monitoring was conducted by overlaying the initial powder X-ray diffractograms (PXRD) of the samples from 0 months with the patterns generated thereafter. There has been a decline in the number of levothyroxine tablets recalled over the years. The highest numbers of recalls were recorded in the years 2013 [33] and 2020 [23]; no recalls occurred in the years 2019 and 2022. All of the brands evaluated met the USP 95.0-105.0% assay requirements at 1.5 months under accelerated conditions; only one of the brands complied at 3 months. Under ambient conditions, two brands were stable at 6 months, with borderline assay results. For stability, levothyroxine was found in microgram quantities in the formulations and PXRD could not detect changes at these low levels. However, we found some distinguishing data for samples under stress conditions.
PubMed: 38256876
DOI: 10.3390/ph17010042