RESUMEN
Background: Research comparing artificial intelligence and machine learning (AI/ML) methods with classical statistical methods applied to large population health databases is limited. Objectives: This retrospective cohort study aimed to compare the predictive performance of AI/ML algorithms against conventional multivariate logistic regression models using linked health administrative data. Methods: Using Ontario's population health databases, we created a cohort of residents of the city of Ottawa, Ontario, who underwent a PCR test for COVID-19 between March 10, 2020, and May 13, 2021. Using demographic, socio-economic and health data (including COVID-19 PCR test results and available, symptom data), we developed predictive models for the purpose of COVID-19 case identification using the following approaches: classical multivariate logistic regression (LR); deep neural network (DNN); random forest (RF); and gradient boosting trees (GBT). Model performance comparisons were made using the area under the curve (AUC) swarm plot for 10-fold cross-validation. Results: The cohort consisted of n = 351,248 Ottawa residents tested for COVID-19 during the study period. Among whom, a total of n = 883,879 unique COVID-19 tests were performed (2.6 % positive test results). Inclusion of COVID-19 symptoms data in the analysis improved model performance and variable predictive value across all tested models (p < 0.0001), with the 10-fold cross-validation AUC increasing to near or over 0.7 in all models when symptoms data were included. In various pairwise comparisons, the GBT method had the highest predictive ability (AUC = 0.796 ± 0.017), significantly outperforming multivariate logistic regression and the other AI/ML approaches. Conclusions: Conventional multivariate regression-based models are better than some and worse than other machine learning algorithms to provide good predictive accuracy in a moderate dataset with a reasonable number of features. However, whenever possible, the AI/ML GBT approach should be considered.
RESUMEN
BACKGROUND: Appropriate use of medication is a key indicator of the quality of care provided in long-term care (LTC). The objective of this study was to determine whether resident-facility language concordance/discordance is associated with the odds of potentially inappropriate prescribing of antipsychotics (PIP-AP) in LTC. METHODS: We conducted a population-based, retrospective cohort study of LTC residents in Ontario, Canada from 2010 to 2019. We obtained resident language from standardized resident assessments, and derived facility language by determining the proportion of residents belonging to each linguistic group within individual LTC homes. Using linked administrative databases, we identified all instances of PIP-AP during a 1-year follow-up period. PIP-AP was defined using the STOPP-START criteria, which have previously been shown to predict adverse clinical events such as emergency department (ED) visits and hospitalizations. The association between linguistic factors and PIP-AP was assessed using adjusted multivariable logistic regression analysis. RESULTS: We identified 198,729 LTC residents consisting of 162,814 Anglophones (81.9%), 6,230 Francophones (3.1%), and 29,685 Allophones (14.9%). The odds of PIP-AP of were higher for both Francophones (aOR 1.15, 95% CI 1.08-1.23) and Allophones (aOR 1.11, 95% CI 1.08-1.15) when compared to Anglophones. When compared to English LTC homes, French LTC homes had greater odds of PIP-AP (aOR 1.12, 95% CI 1.05-1.20), while Allophone homes had lower odds of PIP-AP (aOR 0.82, 95% CI 0.77-0.86). Residents living in language-discordant LTC homes had higher odds of PIP-AP when compared to LTC residents living in language-concordant LTC homes (aOR 1.07, 95% CI 1.04-1.10). CONCLUSION: This study identified linguistic factors related to the odds of PIP-AP in LTC, suggesting that the linguistic environment may have an impact on the quality of care provided to residents.
Asunto(s)
Antipsicóticos , Prescripción Inadecuada , Cuidados a Largo Plazo , Casas de Salud , Humanos , Ontario/epidemiología , Estudios Retrospectivos , Masculino , Femenino , Anciano , Antipsicóticos/uso terapéutico , Antipsicóticos/efectos adversos , Anciano de 80 o más Años , Lenguaje , Estudios de CohortesRESUMEN
Reports suggest possible risks of adverse cardiovascular reactions, including heart failure, associated with non-ergot dopamine agonist (DA) use in Parkinson's disease (PD). The objectives of our review were to evaluate the risk of heart failure and other adverse cardiovascular reactions in PD patients who received a non-ergot DA compared with other anti-PD pharmacological interventions, placebo, or no intervention. Studies were identified via searches of six bibliographic databases. Randomized controlled trials (RCTs) and non-randomized studies (NRS) were eligible for study inclusion. Random-effect meta-analyses were performed to estimate adverse cardiovascular reaction risks. Quality of evidence was assessed using GRADE. In total, forty-four studies (thirty-six RCTs and eight NRS) satisfied our inclusion criteria. A single RCT found no significant difference in the risk of heart failure with ropinirole compared with bromocriptine (odds ratio (OR) 0.39, 95% confidence interval (CI) 0.07 to 2.04; low certainty). Conversely, three case-control studies reported a risk of heart failure with non-ergot DA treatment. The quality of evidence for the risk of heart failure was judged as low or very low. Findings suggest that non-ergot DA use may be associated with adverse cardiovascular outcomes, including heart failure. Studies are needed to better understand cardiovascular risks associated with PD treatment.
RESUMEN
BACKGROUND: Clinicians and patients often face a decision to continue or discontinue statins. We examined the impact of discontinuation of statins compared with continuation on clinical outcomes (all-cause mortality, cardiovascular [CV] mortality, CV events, and quality of life). METHODS: We conducted a systematic review. Randomized controlled trials (RCTs), cohort studies, case-control studies, and quasi-randomized studies among people ≥18 years were eligible. We searched MEDLINE, Embase, and Cochrane Central Registry (inception to August 2023). Two independent reviewers performed screening and extracted data. Quality assessment was performed by one author and verified by another. We summarized results narratively, performed meta-analysis for a subset of studies, and used GRADE to assess certainty of evidence. We summarized findings in the subgroup of persons ≥75 years. RESULTS: We retrieved 8369 titles/abstracts; 37 reports from 36 studies were eligible. This comprised 35 non-randomized studies (n = 1,708,684) and 1 RCT (n = 381). The 1 RCT was conducted among persons with life expectancy <1 year and showed there is probably no difference in 60-day mortality (risk difference = 3.5%, 90% CI -3.5 to 10.5) for statin discontinuation compared with continuation. Non-randomized studies varied in terms of population and setting, but consistently suggested that statin discontinuation might be associated with a relative increased risk of mortality (hazard ratio (HR) 1.92, 95% CI 1.52 to 2.44, nine studies), CV mortality (HR 1.63, 95% CI 1.27 to 2.10, five reports), and CV events (HR 1.31, 95% CI 1.23 to 1.39, eight reports). Findings in people ≥75 years were consistent with main results. There was a high degree of uncertainty in findings from non-randomized studies due to methodological limitations. CONCLUSIONS: Statin discontinuation does not appear to affect short-term mortality near end-of-life based on one RCT. Outside of this population, findings from non-randomized studies consistently suggested statin discontinuation may be associated with worse outcomes, though this is uncertain.
RESUMEN
BACKGROUND: Language-concordant health care, or health care in a patient's language of choice, is an important element of health accessibility that improves patient safety and comfort and facilitates an increased quality of care. However, prior research has found that linguistic minorities often face higher travel burdens to access language-concordant care compared to the general population. OBJECTIVE: This study intended to assess patient experiences and satisfaction with an online interactive physician map that allows patients to find family physicians who speak their preferred language in and around Ottawa, Ontario, Canada, as a means of identifying areas of improvement. METHODS: This study used an online survey with questions related to user satisfaction. Responses to Likert-scale questions were compiled as summary statistics and short-answer responses underwent thematic analysis. The study setting was Ottawa and Renfrew County, Ontario, and the surrounding region, including the province of Quebec. RESULTS: A total of 93 respondents completed the survey and self-identified as living in Ontario or Quebec. Overall, 57 (61%) respondents were "very satisfied" or "somewhat satisfied" with the map, 16 (17%) were "neither satisfied nor dissatisfied," and 20 (22%) were "very dissatisfied" or "somewhat dissatisfied." We found no significant differences in satisfaction by preferred language, age group, physician attachment, or intended beneficiary. A total of 56 respondents provided short-answer responses to an open-ended question about map improvements. The most common specific suggestion was to show which physicians are accepting new patients (n=20). Other suggestions included data refreshes (n=6), user interface adjustments (n=23), and additional languages (n=2). Some participants also provided positive feedback (n=5) or expressed concern with their inability to find a family physician (n=5). Several comments included multiple suggestions. CONCLUSIONS: While most patients were satisfied with the online map, a significant minority expressed dissatisfaction that the map did not show which family physicians were accepting new patients. This suggests that there may be public interest in an accessible database of which family physicians in Ontario are currently accepting new patients.
RESUMEN
OBJECTIVE: To understand the current landscape of artificial intelligence (AI) for family medicine (FM) research in Canada, identify how the College of Family Physicians of Canada (CFPC) could support near-term positive progress in this field, and strengthen the community working in this field. COMPOSITION OF THE COMMITTEE: Members of a scientific planning committee provided guidance alongside members of a CFPC staff advisory committee, led by the CFPC-AMS TechForward Fellow and including CFPC, FM, and AI leaders. METHODS: This initiative included 2 projects. First, an environmental scan of published and gray literature on AI for FM produced between 2018 and 2022 was completed. Second, an invitational round table held in April 2022 brought together AI and FM experts and leaders to discuss priorities and to create a strategy for the future. REPORT: The environmental scan identified research related to 5 major domains of application in FM (preventive care and risk profiling, physician decision support, operational efficiencies, patient self-management, and population health). Although there had been little testing or evaluation of AI-based tools in practice settings, progress since previous reviews has been made in engaging stakeholders to identify key considerations about AI for FM and opportunities in the field. The round-table discussions further emphasized barriers to and facilitators of high-quality research; they also indicated that while there is immense potential for AI to benefit FM practice, the current research trajectory needs to change, and greater support is needed to achieve these expected benefits and to avoid harm. CONCLUSION: Ten candidate action items that the CFPC could adopt to support near-term positive progress in the field were identified, some of which an AI working group has begun pursuing. Candidate action items are roughly divided into avenues where the CFPC is well-suited to take a leadership role in tackling priority issues in AI for FM research and specific activities or initiatives the CFPC could complete. Strong FM leadership is needed to advance AI research that will contribute to positive transformation in FM.
Asunto(s)
Inteligencia Artificial , Medicina Familiar y Comunitaria , Humanos , Médicos de Familia , CanadáRESUMEN
OBJECTIVES: This study examined potentially inappropriate prescribing (PIP) of medication and its association with probable delirium among long-term care (LTC) residents in Ontario, Canada. DESIGN: Population-based cross-sectional study using provincial health administrative data, including LTC assessment data via the Resident Assessment Instrument-Minimum Dataset version 2.0 (RAI-MDS 2.0). SETTING AND PARTICIPANTS: LTC residents in Ontario between January 1, 2016, and December 31, 2019. METHODS: We used residents' first RAI-MDS 2.0 assessment in the study period as the index assessment. Probable delirium was identified via the delirium Clinical Assessment Protocol. Medication use in the 2 weeks preceding assessment was captured using medication claims data. PIP was measured using the STOPP/START criteria and 2015 Beers criteria, with residents classified as having 0, 1, 2, or 3+ instances of PIP. Relationships between PIP and probable delirium was assessed via bivariate and multivariable logistic regression models. RESULTS: The study population included 171,190 LTC residents (mean age 84.5 years, 66.8% female, 62.9% with dementia). More than half (51.8%) of residents had 1+ instances of PIP and 21% had 3+ instances of PIP according to the STOPP/START criteria; PIP prevalence was slightly lower when assessed using Beers criteria (36.5% with 1+, 11.1% with 3+). Overall, 3.7% of residents had probable delirium. The prevalence of probable delirium increased as the number of instances of PIP increased, with residents with 3+ instances of STOPP/START PIP being 1.66 times more likely (95% CI 1.56-1.77) to have probable delirium compared to those with no instances of PIP. Similar findings were observed when PIP was measured using the Beers criteria. Central nervous system (CNS)-related PIP criteria showed a stronger association with probable delirium than non-CNS-related PIP criteria. CONCLUSIONS AND IMPLICATIONS: This population-based study highlighted that PIP was highly prevalent in long-term care residents and was associated with an increased prevalence of probable delirium.
Asunto(s)
Delirio , Prescripción Inadecuada , Humanos , Femenino , Anciano de 80 o más Años , Masculino , Cuidados a Largo Plazo , Estudios Transversales , Ontario/epidemiología , Delirio/tratamiento farmacológico , Delirio/epidemiologíaRESUMEN
Objective: To evaluate if access to team-based primary care is related to medication management outcomes for older adults. Methods: We completed two retrospective cohort studies using administrative health data for older adults (66+) in Ontario (n = 428,852) and Québec (n = 310,198) who were rostered with a family physician (FP) between the 2001/02 and 2017/18 fiscal years. We generated matched comparison groups of older adults rostered to an FP practicing in a team-based model, and older adults rostered to an FP in a non-team model. We compared the following outcomes between these groups: any adverse drug reactions (ADRs), any potentially inappropriate prescription (PIP), and polypharmacy. Average treatment effects of access to team-based care were estimated using a difference-in-differences estimator. Results: The risk of an ADR was 22 % higher (RR = 1.22, 95 % CI = 1.18, 1.26) for older adults rostered to a team-based FP in Québec and 6 % lower (RR = 0.943, 95 % CI = 0.907, 0.978) in Ontario. However, absolute risk differences were less than 0.5 %. Differences in the risk of polypharmacy were small in Québec (RR = 1.005, 95 % CI = 1.001, 1.009) and Ontario (RR = 1.004, 95 % CI = 1.001, 1.007) and had absolute risk differences of less than 1 % in both provinces. Effects on PIP were not statistically or clinically significant in adjusted models. Interpretation: We did not find evidence that access to team-based primary care in Ontario or Québec meaningfully improved medication management outcomes for older adults.
RESUMEN
BACKGROUND: Prior studies have demonstrated the negative impact of language barriers on access, quality, and safety of healthcare, which can lead to health disparities in linguistic minorities. As the population ages, those with multiple chronic diseases will require increasing levels of home care and long-term services. This study described the levels of multimorbidity among recipients of home care in Ontario, Canada by linguistic group. METHODS: Population-based retrospective cohort of 510,685 adults receiving home care between April 1, 2010, to March 31, 2018, in Ontario, Canada. We estimated and compared prevalence and characteristics of multimorbidity (2 or more chronic diseases) across linguistic groups (Francophones, Anglophones, Allophones). The most common combinations and clustering of chronic diseases were examined. Logistic regression models were used to explore the main predictors of 'severe' multimorbidity (defined as the presence of five or more chronic diseases). RESULTS: The proportion of home care recipients with multimorbidity and severe multimorbidity was 92% and 44%, respectively. The prevalence of multimorbidity was slightly higher among Allophones (93.6%) than among Anglophones (91.8%) and Francophones (92.4%). However, Francophones had higher rates of cardiovascular and respiratory disease (64.9%) when compared to Anglophones (60.2%) and Allophones (61.5%), while Anglophones had higher rates of cancer (34.2%) when compared to Francophones (25.2%) and Allophones (24.3%). Relative to Anglophones, Allophones were more likely to have severe multimorbidity (adjusted OR = 1.04, [95% CI: 1.02-1.06]). CONCLUSIONS: The prevalence of multimorbidity among Ontarians receiving home care services is high; especially for whose primary language is a language other than English or French (i.e., Allophones). Understanding differences in the prevalence and characteristics of multimorbidity across linguistic groups will help tailor healthcare services to the unique needs of patients living in minority linguistic situations.
Asunto(s)
Servicios de Atención de Salud a Domicilio , Multimorbilidad , Humanos , Ontario/epidemiología , Estudios Retrospectivos , Prevalencia , Lingüística , Enfermedad CrónicaRESUMEN
OBJECTIVES: To determine the clinical and economic impact of a community-based, hybrid model of in-person and virtual care by comparing health-system performance of the rural jurisdiction where this model was implemented with neighbouring jurisdictions without such a model and the broader regional health system. DESIGN: A cross-sectional comparative study. SETTING: Ontario, Canada, with a focus on three largely rural public health units from 1 April 2018 until 31 March 2021. PARTICIPANTS: All residents of Ontario, Canada under the age of 105 eligible for the Ontario Health Insurance Plan during the study period. INTERVENTIONS: An innovative, community-based, hybrid model of in-person and virtual care, the Virtual Triage and Assessment Centre (VTAC), was implemented in Renfrew County, Ontario on 27 March 2020. MAIN OUTCOME MEASURES: Primary outcome was a change in emergency department (ED) visits anywhere in Ontario, secondary outcomes included changes in hospitalisations and health-system costs, using per cent changes in mean monthly values of linked health-system administrative data for 2 years preimplementation and 1 year postimplementation. RESULTS: Renfrew County saw larger declines in ED visits (-34.4%, 95% CI -41.9% to -26.0%) and hospitalisations (-11.1%, 95% CI -19.7% to -1.5%) and slower growth in health-system costs than other rural regions studied. VTAC patients' low-acuity ED visits decreased by -32.9%, high-acuity visits increased by 8.2%, and hospitalisations increased by 30.0%. CONCLUSION: After implementing VTAC, Renfrew County saw reduced ED visits and hospitalisations and slower health-system cost growth compared with neighbouring rural jurisdictions. VTAC patients experienced reduced unnecessary ED visits and increased appropriate care. Community-based, hybrid models of in-person and virtual care may reduce the burden on emergency and hospital services in rural, remote and underserved regions. Further study is required to evaluate potential for scale and spread.
Asunto(s)
Costos de la Atención en Salud , Hospitalización , Humanos , Estudios Transversales , Ontario , Población Rural , Servicio de Urgencia en HospitalRESUMEN
BACKGROUND: Although language concordance between patients and primary care physicians results in better quality of care and health outcomes, little research has explored inequities in travel burden to access primary care people of linguistic minority groups in Canada. We sought to investigate the travel burden of language-concordant primary care among people who speak French but not English (French-only speakers) and the general public in Ottawa, Ontario, and any inequities in access across language groups and neighbourhood ruralities. METHODS: Using a novel computational method, we estimated travel burden to language-concordant primary care for the general population and French-only speakers in Ottawa. We used language and population data from Statistics Canada's 2016 Census, neighbourhood demographics from the Ottawa Neighbourhood Study, and collected the main practice location and language of primary care physicians from the College of Physicians and Surgeons of Ontario. We measured travel burden using Valhalla, an open-source road-network analysis platform. RESULTS: We included data from 869 primary care physicians and 916 855 patients. Overall, French-only speakers faced greater travel burdens than the general population to access language-concordant primary care. Median differences in travel burden were statistically significant but small (median difference in drive time 0.61 min, p < 0.001, interquartile range 0.26-1.17 min), but inequities in travel burden between groups were larger among people living in rural neighbourhoods. INTERPRETATION: French-only speakers in Ottawa face modest - but statistically significant - overall inequities in travel burden when accessing primary care, compared with the general population, and higher inequities in specific neighbourhoods. Our results are of interest to policy-makers and health system planners, and our methods can be replicated and used as comparative benchmarks to quantify access disparities for other services and regions across Canada.
Asunto(s)
Acceso a Atención Primaria , Médicos , Humanos , Ontario/epidemiología , Estudios Transversales , LenguajeRESUMEN
BACKGROUND: Quinolones are popular antibiotics that are known for their potency, broad coverage, and reasonable safety. Concerns have been raised about a possible association between quinolones and retinal detachment (RD). METHODS: We conducted a nested case-control study using electronic health records (EHR) from the Health Facts® Database. The initial cohort included all patients who were admitted between 2000 and 2016, with no history of eye disease, and had a minimum medical history of one year. Eligible cases comprised inpatients who were first admitted with a primary diagnosis of RD between 2010 and 2015. Each eligible case was matched without replacement to five unique controls by sex, race, age, and period-at-risk. We used conditional logistic regression to calculate RD risk, adjusting for exposure to other medications, and major risk factors. RESULTS: We identified 772 cases and 3860 controls. Whereas our primary analysis of all subjects revealed no quinolone-associated RD risk, elevated but non-significant risks were noted in African Americans (ciprofloxacin and levofloxacin), those aged 56-70 years old (moxifloxacin), and women (ciprofloxacin). CONCLUSION: Our study did not identify an elevated RD risk within 30 days following systemic administration of quinolone antibiotics. Suggestions of increased risk observed in some population subgroups warrant further investigation.
Asunto(s)
Quinolonas , Desprendimiento de Retina , Anciano , Antibacterianos/efectos adversos , Estudios de Casos y Controles , Ciprofloxacina , Registros Electrónicos de Salud , Femenino , Humanos , Persona de Mediana Edad , Quinolonas/efectos adversos , Desprendimiento de Retina/inducido químicamente , Desprendimiento de Retina/epidemiologíaRESUMEN
BACKGROUND: The shortage of available organs for life-saving transplants persists worldwide. While a majority support donating their organs or tissue when they die, many have not registered their wish to do so. When registered, next of kin are much more likely to follow-through with the decision to donate. In many countries, most people visit their family physician office each year and this setting is a promising, yet underused, site where more people could register for deceased organ donation. Our primary aim was to evaluate the effectiveness of an intervention to promote organ donation registration in family physician's offices. METHODS: We developed an intervention to address barriers and enablers to organ donation registration that involved physician office reception staff inviting patients to register on a tablet in the waiting room while they waited for their appointment. We conducted a cross-sectional stepped-wedge cluster randomized controlled registry trial to evaluate the intervention. We recruited six family physician offices in Canada. All offices began with usual care and then every two weeks, one office (randomly assigned) started the intervention until all offices delivered the intervention. The primary outcome was registration for deceased organ donation in the provincial organ registration registry, assessed within the 7 days of the physician visit. At the end of the trial, we also conducted interviews with clinic staff to assess any barriers and enablers to delivering the intervention. RESULTS: The trial involved 24,616 patient visits by 13,562 unique patients: 12,484 visits in the intervention period and 12,132 in the control period. There was no statistically significant difference in the percentage of patients registered for deceased organ donation in the intervention versus control period (48.0% vs 46.2%; absolute difference after accounting for the secular trend: 0.12%; 95% CI: - 2.30, 2.54; p=0.92). Interviews with clinic staff indicated location of the tablet within a waiting room, patient rapport, existing registration, confidence and motivation to deliver the intervention and competing priorities as barriers and enablers to delivery. CONCLUSIONS: Our intervention did not increase donor registration. Nonetheless, family physician offices may still remain a promising setting to develop and evaluate better interventions to increase organ donation registration. TRIAL REGISTRATION: NCT03213171.
Asunto(s)
Médicos de Familia , Obtención de Tejidos y Órganos , Estudios Transversales , Humanos , Sistema de Registros , Salas de EsperaRESUMEN
BACKGROUND: Quinolones comprise a class of antibiotics that are globally preferred for treating a wide range of bacterial infections due to their potency, broad coverage, favorable pharmacologic profile, and mostly mild to moderate adverse reactions. Spontaneous reports on adverse drug events (ADE) and data from some pharmacoepidemiologic studies have raised concerns regarding quinolones and risk of retinal detachment (RD). This study examined ADE reports submitted to FDA adverse event reporting system (FAERS) for evidence on quinolone-associated RD risk. RESEARCH DESIGN AND METHODS: We identified all RD reports in FAERS between 2010-2019. We compared ADE signals between quinolones and selected medications that were previously associated with RD, and with reference medications not known to cause RD. For signal detection, we used two techniques: the proportional reporting ratio (PRR) and multi-item gamma Poisson shrinker (MGPS), which are known for their higher sensitivity and specificity for ADE signal detection, respectively. RESULTS: Moxifloxacin showed a positive and significant PRR signal for RD [PRR: 2.54 (1.60, 4.04)], and a marginally significant EBGM signal [EBGM: 2.21 (1.41, 3.02)]. CONCLUSION: Moxifloxacin is the only quinolone showing a positive disproportionality signal for RD. Further epidemiologic research is needed to clarify the association between moxifloxacin and RD risk.
Asunto(s)
Antibacterianos/efectos adversos , Moxifloxacino/efectos adversos , Quinolonas/efectos adversos , Desprendimiento de Retina/inducido químicamente , Adolescente , Adulto , Sistemas de Registro de Reacción Adversa a Medicamentos/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Antibacterianos/administración & dosificación , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Persona de Mediana Edad , Moxifloxacino/administración & dosificación , Farmacoepidemiología , Farmacovigilancia , Quinolonas/administración & dosificación , Desprendimiento de Retina/epidemiología , Riesgo , Sensibilidad y Especificidad , Estados Unidos , United States Food and Drug Administration , Adulto JovenRESUMEN
BACKGROUND AND AIM: Quinolones are a potent and globally popular group of antibiotics that are used to treat a wide range of infections. Some case reports have raised concern about their possible association with acute hepatic failure (AHF). Data from the US FDA Adverse Event Reporting System were evaluated for signals of AHF in association with systemically administered quinolone antibiotics. METHODS: AHF reports between 1969 and 2019q2, with a focus on 2010-2019q2, were analyzed. Specifically, AHF reports linked to non-quinolone antibiotics of known hepatotoxicity were compared to reports with non-quinolone, non-hepatotoxic (reference) antibiotics; and AHF reports with quinolones were also compared to reports with the same group of reference antibiotics. Two disproportionality signal detection techniques (proportional reporting ratio, PRR, and empirical Bayes geometric mean, EBGM) were used to assess the AHF signal for both analyses. RESULTS: Only ciprofloxacin showed a marginal and significant AHF signal (PRR: 1.85 [1.21, 2.81]; EBGM: 1.54 [1.06, 1.81]); moxifloxacin, levofloxacin, and ofloxacin showed weak and nonsignificant signals. CONCLUSION: Further pharmacovigilance studies are required to confirm the association between ciprofloxacin and AHF seen in the present analysis.
RESUMEN
BACKGROUND AND AIM: Quinolones are globally popular antibiotics with proven potency, broad coverage, and reasonable safety. However, some concerns were raised as to their possible association with acute liver failure (ALF). The aim of this study is to assess ALF risk within 30 days of receiving a systemically administered quinolone antibiotic, in individuals with no history of liver/diseases. METHODS: We conducted a nested case-control study using electronic health records from the Cerner Health Facts. The initial cohort (n = 35 349 943) included all patients who were admitted between 2000 and 2016, with no history of liver diseases, and had a minimum medical history of one year. Eligible cases were inpatients who were first diagnosed with ALF between 2010 and 2015. Using incidence density sampling, each case was matched with up to five unique controls by sex, race, age at index encounter, and period-at-risk. We used conditional logistic regression to calculate the odds ratio and 95% confidence interval for ALF risk, upon adjusting for exposure to other medications, and major confounders (diabetes mellitus and alcohol abuse). We used the STROBE Statement for reporting on our study. RESULTS: We identified 3151 cases and 15 657 controls. Our primary analysis did not reveal an association between quinolones and ALF risk. However, some risk was identified among those with no or few comorbidities, those ≤ 60 years of age, women, men, African Americans, and Caucasians. CONCLUSION: Although our study does not suggest an overall association between quinolones and ALF, elevated risks seen in some subgroups warrant further investigation.
Asunto(s)
Fallo Hepático Agudo , Antibacterianos/efectos adversos , Estudios de Casos y Controles , Bases de Datos Factuales , Registros Electrónicos de Salud , Femenino , Humanos , Fallo Hepático Agudo/inducido químicamente , Fallo Hepático Agudo/epidemiología , Masculino , QuinolonasRESUMEN
OBJECTIVE: The aim of this study was to determine the health system costs from hospitalizations, emergency department (ED) visits, and medications due to potentially inappropriate prescribing (PIP) in Ontario, Canada, at the population-level. METHODS: A retrospective cohort of individuals ≥ 66 years of age and prescribed at least one medication from April 2002 to March 2015 was identified using linked population-level health administrative databases from Ontario, Canada. Patients were identified as having PIP or no PIP by applying a subset of the Screening Tool of Older Persons' Potentially Inappropriate Prescribing/Screening Tool to Alert Doctors to Right Treatment (STOPP/START) criteria. The number of days spent in hospital, new medications prescribed, and ED visits in the 90 days following PIP or patient index date were captured, as well as the total costs from each of these health services. Count regression models were used to generate incidence rate ratios (IRRs) for each outcome given the presence of PIP versus no PIP and combined with the prevalence of PIP to generate population attributable fractions (PAFs). The PAF was then multiplied by the cost for each health service to obtain the costs attributable to PIP in the whole cohort, and by age and sex. RESULTS: PIP was associated with an increased rate of hospitalization (IRR 2.77, 95% confidence interval [CI] 2.72-2.82), ED visits (IRR 1.87, 95% CI 1.82-1.92), and newly prescribed medications (IRR 1.13, 95% CI 1.13-1.14), resulting in PAFs of 55.7, 37.9, and 5.0% for each outcome, respectively. PIP was associated with 38.8% of the total spent on these healthcare services ($1.22 billion) in the 90 days after PIP. Costs attributable to PIP decreased with age despite increasing prevalence. CONCLUSIONS: PIP in older adults is a significant source of health system costs from healthcare service use beyond medication costs, with a significant portion of hospitalizations and ED visit costs attributable to PIP. Future work should focus on identifying strategies and priorities for intervention.
RESUMEN
OBJECTIVE: To develop key performance indicators that evaluate the effectiveness of a prescription medication system. METHODS: A modified RAND/UCLA appropriateness method was used to develop key performance indicators (KPIs) for a prescription medication system. A broad list of potential KPIs was compiled. A multidisciplinary group composed of 21 experts rated the potential KPIs. A face-to-face meeting was held following the first rating exercise to discuss each potential KPI individually. The expert panel undertook a final rating of KPIs. The final set of KPIs were those indicators where at least 80 percent of experts rated the indicator highly i.e. rating of ≥ 7 on a scale from 1 to 9. RESULTS: 292 KPIs were identified from the published literature. After removing duplicates and combining similar indicators 71 KPIs were included. The final ranking resulted in six indicators being ranked 7 or higher by 80% of the respondents and an additional seven indicators being ranked 7 or higher by ≥70 but ≤80% of respondents. The six selected indicators include four specific disease areas, measure structural and process aspects of health service delivery, and assessed three of the domains of healthcare quality: efficiency, effectiveness, and safety. CONCLUSIONS: These indicators are recommended as a starting point to assess the current performance of prescription medication systems. Consideration should be given to developing indicators in additional disease areas as well as indicators that measure the domains of timeliness and patient-centeredness. Future work should focus on the feasibility of measuring these indicators.
Asunto(s)
Sistemas de Medicación/normas , Prescripciones/normas , Indicadores de Calidad de la Atención de Salud/normas , Canadá , Testimonio de Experto , Femenino , Humanos , MasculinoRESUMEN
OBJECTIVES: To assess consistency in the format and content, and overlap of subject and timing, of medication safety letters issued by regulatory health authorities to healthcare providers in Canada, the USA and the UK. DESIGN: A cross-sectional study comparing medication safety letters issued for the purpose of alerting healthcare providers to newly identified medication problems associated with medications already on the market. SETTING: Online databases operated by Health Canada, the US Food and Drug Administration and the UK Medicines and Healthcare products Regulatory Agency were searched to select medication safety letters issued between 1 January 2010 and 31 December 2014. Format, content and timing of each medication safety letter were assessed using an abstraction tool comprising 21 characteristics deemed relevant by consensus of the research team. MAIN OUTCOME MEASURES: Main outcome measures included, first, characteristics (format and content) of medication safety letters and second, overlap of subject and release date across countries. RESULTS: Of 330 medication safety letters identified, 227 dealt with unique issues relating to medications available in all three countries. Of these 227 letters, 21 (9%) medication problems were the subject of letters released in all three countries; 40 (18%) in two countries and 166 (73%) in only one country. Only 13 (62%) of the 21 letters issued in all three countries were released within 6 months of each other. CONCLUSIONS: Significant discrepancies in both the subject and timing of medication safety letters issued by health authorities in three countries (Canada, the USA and the UK) where medical practice is otherwise comparable, raising questions about why, how and when medication problems are identified and communicated to healthcare providers by the authorities. More rapid communication of medication problems and better alignment between authorities could enhance patient safety.