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Pattern and appropriateness of antibiotic prescriptions for upper respiratory tract infections in primary care paediatric patients.
Bianco, A, Licata, F, Nobile, CG, Napolitano, F, Pavia, M
International journal of antimicrobial agents. 2022;(1):106469
Abstract
OBJECTIVES The aim of this cross-sectional study was to investigate the pattern of antibiotic prescriptions for upper respiratory tract infections (URTIs) in children seen by primary care paediatricians (PCPs). METHODS Data were collected from face-to-face interviews administered to a sample of parents of outpatient children aged 0-14 years in two regions in Southern Italy. To be eligible, children had to be diagnosed with sinusitis, pharyngotonsillitis, otitis media, bronchitis, influenza or a common cold. The presence of an indication of antibiotic therapy was evaluated according to national and international guidelines. RESULTS An antibiotic prescription was indicated in 57 (10.1%) of the sampled patients, of whom 33.3% did not receive an antibiotic prescription; among the 508 patients for whom an antibiotic prescription was not indicated, 27.4% received a prescription. Of all PCP consultations, 72% were appropriate (an antibiotic was prescribed when indicated and not prescribed when not indicated), whilst an antibiotic prescription not indicated by guidelines was given to 24.6% of the participants, and 3.4% of the sample did not receive an antibiotic prescription when indicated. The most frequently prescribed antibiotic was amoxicillin with clavulanic acid. A rapid microbiological examination was performed in two patients. CONCLUSIONS The study findings highlight a high rate of sub-optimal antibiotic therapeutic profile. Over-prescription of antibiotic therapy and the use of broad-spectrum molecules are widespread in children with URTIs. Antibiotic under-prescription, which may deprive paediatric patients of an effective treatment when indicated, also occurs.
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Valproate prescription to women of childbearing age in English primary care: repeated cross-sectional analyses and retrospective cohort study.
Gaudio, M, Konstantara, E, Joy, M, van Vlymen, J, de Lusignan, S
BMC pregnancy and childbirth. 2022;(1):73
Abstract
BACKGROUND Valproate is a teratogenic drug that should be avoided during the preconception period and pregnancy. The aim was to explore general practitioners' (GPs) prescription patterns over time, describe trends, and explore inter-practice variation within primary care. METHODS We identified women of childbearing age (12-46 years old) in the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC) sentinel network. We performed repeated cross-sectional analyses from 2004 to 2018 to determine rates of prescription and a retrospective cohort estimated the prevalence of use of valproate during pregnancy. RESULTS In 2004, 0.31% (95% Confidence Interval (95%CI):0.18 to 0.44%) women were prescribed valproate, decreasing to 0.16% (95%CI:0.07 to 0.24%) by 2018. Among women with epilepsy, the rate fell from 15.2% (95%CI:14.4 to 16.0%) to 8.8% (95% CI:8.2 to 9.7%) over the same period. In 2018, almost two thirds (62.2%) of women who were prescribed valproate had epilepsy only, whereas bipolar disorder and migraine accounted for 15.8% and 7.4% respectively. Contraceptive prescriptions did not increase over time, and only in 2018 was there greater odds of being prescribed contraception (OR 1.41, 95%CI:1.08 to 1.45). Just under a fifth (19.7%) of women were prescribed valproate during their pregnancy; two out of three of these pregnancies were preceded by folic acid prescription (5 mg). While some practices reduced their rate of valproate prescription, others did not. CONCLUSIONS Regulatory guidelines have changed GPs' prescription patterns in women of childbearing potential for valproate but not for contraception. Further research is needed to identify the barriers of GPs and women of childbearing potential to undertaking contraception.
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Increasing disparity between Society for Vascular Surgery guidelines for infrarenal abdominal aortic aneurysm repair and real-world practice.
Schlieder, I, Kontopidis, I, Blackwood, S, Krol, E, Dietzek, AM
Journal of vascular surgery. 2021;(4):1227-1233.e1
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OBJECTIVE The current Society for Vascular Surgery (SVS) guidelines, based on randomized controlled trials published more than a decade ago, recommend a minimum threshold diameter of 5.5 cm for infrarenal abdominal aortic aneurysm (iAAA) repair. It is unknown whether practice patterns with respect to size of repair have changed since the publication of these guidelines. We aimed to evaluate the real-world practice of vascular surgeons in our region with respect to iAAA size at the time of repair, whether this has changed over the past 12 years and if any changes were associated with the repair type, open vs endovascular. METHODS The Vascular Study Group of New England (VSGNE) database was used to identify all patients who received iAAA repair between 2003 and 2015. The primary end point was to quantify the annual percentage of iAAAs repaired in different size categories (≥5.5 cm; <5.5 cm but ≥5.0 cm; <5.0 cm) over the study time period and by type of repair. The secondary end points were morbidity and mortality in these groups. We excluded nonelective cases (ruptured or symptomatic), patients with coexisting iliac artery aneurysms, and those missing critical data. RESULTS A total of 5314 patients with iAAA repairs (1538 open, 3776 endovascular) were identified in the VSGNE database during the study period. In 40% (2110 of 5314) of patients, repair was performed for aneurysms <5.5 cm, with endovascular aneurysm repair (EVAR) comprising 75% (1581 of 2110) and open 25% (529 of 2110). More EVARs were performed for <5.5 cm in 2015 (46%) compared with 2003 (33%) (P < .05, n - 1 χ2) with an average increase of 1.1%/y. There was also a non-statistically significant increase in open repair of small aneurysms (0.7%/y; P = .759). Overall, 30-day mortality was 1.11% in the EVAR group (0.54% in <5.0 cm, 0.91% in ≥5.0 but <5.5 cm, and 1.55% in ≥5.5 cm), compared with 3% in the open group (2.88%, 1.79%, and 3.77%, respectively) with no significant change in mortality in either group over time. CONCLUSIONS Despite the SVS guidelines suggesting surveillance rather than repair of iAAA <5.5 cm, an increasing proportion of repairs in the VSGNE database were performed below that threshold. The reasons for this are likely multifactorial and might include a lesser complexity and lower operative mortality for smaller aneurysms and markedly improved third- and fourth-generation stent graft technology with possibly better long-term survival. As such, it may be time to re-examine the current guidelines for iAAA repair.
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Impact of changing reimbursement criteria on statin treatment patterns among patients with atherosclerotic cardiovascular disease or cardiovascular risk factors.
Hsu, CY, Chen, WJ, Chen, HM, Tsai, HY, Hsiao, FY
Journal of clinical pharmacy and therapeutics. 2021;(2):415-423
Abstract
WHAT IS KNOWN AND OBJECTIVE Starting 1 August 2013, the eligible cholesterol level for statin reimbursement in patients with atherosclerotic cardiovascular disease (ASCVD) or cardiovascular disease (CVD)-related risk factors changed from LDL-C ≥ 130 mg/dl (or TC ≥ 200 mg/dl) to LDL-C ≥ 100 mg/dl (or TC ≥ 160 mg/dl) in Taiwan, which may modify clinician prescribing behaviours. We aimed to evaluate the impact of changing reimbursement criteria on statin treatment patterns. METHODS A before-after cohort design was conducted using Taiwan's National Health Insurance Research Database. Differences in statin treatment patterns between the pre- and postregulation periods were compared. Two prespecified study cohorts were identified to examine the impacts of this change on those who need statins for "secondary prevention" (patients newly diagnosed with ASCVD) and those who need statins for "primary prevention" (patients newly diagnosed with CVD-related risk factors, such as diabetes mellitus [DM]). Treatment patterns measured in this study included initiation, discontinuation, switching, dose increase, dose decrease and dose maximization. RESULTS The proportion of patients who initiated statins during the postregulation period was higher than that of patients who initiated statins during the preregulation period (eg coronary heart disease (CHD) patients, pre- vs. postregulation: 41.23% vs. 48.25%). Notably, only 30%-40% of patients initiated statin use in the postregulation period across different conditions. In addition, the proportion of patients who discontinued statins remained very high. Even in the postregulation period, more than half of CHD patients discontinued statins during the 1-year follow-up period (eg CHD patients, pre- vs. postregulation: 59.07% vs. 52.75%). WHAT IS NEW AND CONCLUSION The new reimbursement criteria started on 1 August 2013 seemed to lower the barriers of access to the first statin prescription among patients with CHD, cerebrovascular disease (CBVD) and DM. Nevertheless, the proportion of patients who initiated statin use was suboptimal, and the proportion of patients who discontinued statins was very high in the postregulation period.
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Loop Diuretics in Severe Bronchopulmonary Dysplasia: Cumulative Use and Associations with Mortality and Age at Discharge.
Bamat, NA, Nelin, TD, Eichenwald, EC, Kirpalani, H, Laughon, MM, Jackson, WM, Jensen, EA, Gibbs, KA, Lorch, SA
The Journal of pediatrics. 2021;:43-49.e3
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OBJECTIVES To measure between-center variation in loop diuretic use in infants developing severe bronchopulmonary dysplasia (BPD) in US children's hospitals, and to compare mortality and age at discharge between infants from low-use centers and infants from high-use centers. STUDY DESIGN We performed a retrospective cohort study of preterm infants at <32 weeks of gestational age with severe BPD. The primary outcome was cumulative loop diuretic use, defined as the proportion of days with exposure between admission and discharge. Infant characteristics associated with loop diuretic use at P < .10 were included in multivariable models to adjust for center differences in case mix. Hospitals were ranked from lowest to highest in adjusted use and dichotomized into low-use centers and high-use centers. We then compared mortality and postmenstrual age at discharge between the groups through multivariable analyses. RESULTS We identified 3252 subjects from 43 centers. Significant variation between centers remained despite adjustment for infant characteristics, with use present in an adjusted mean range of 7.3% to 49.4% of days (P < .0001). Mortality did not differ significantly between the 2 groups (aOR, 0.98; 95% CI, 0.62-1.53; P = .92), nor did postmenstrual age at discharge (marginal mean, 47.3 weeks [95% CI, 46.8-47.9 weeks] in the low-use group vs 47.4 weeks [95% CI, 46.9-47.9 weeks] in the high-use group; P = .96). CONCLUSIONS A marked variation in loop diuretic use for infants developing severe BPD exists among US children's hospitals, without an observed difference in mortality or age at discharge. More research is needed to provide evidence-based guidance for this common exposure.
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Do Steroids Matter? A Retrospective Review of Premedication for Taxane Chemotherapy and Hypersensitivity Reactions.
Lansinger, OM, Biedermann, S, He, Z, Colevas, AD
Journal of clinical oncology : official journal of the American Society of Clinical Oncology. 2021;(32):3583-3590
Abstract
PURPOSE Despite the widespread use of the taxanes paclitaxel and docetaxel for a variety of cancers and their well-known association with hypersensitivity reactions (HSRs), there is still significant variation in the prescribing practices of steroids for premedication. Premedication almost always includes dexamethasone, which can be associated with multiple adverse effects if taken for extended periods of time. This study reviews the pattern of steroid premedication in patients who received paclitaxel or docetaxel at Stanford Cancer Institute between January 2010 and June 2020. METHODS We used an electronic query of the electronic medical record followed up with a manual review of patient charts to ask whether we could find a correlation between steroid premedication dosing and the incidence or severity of HSRs with the first taxane dose. Variables considered included steroid dose and route, dose and type of taxane, clinical cancer group, sex, and race. RESULTS Five thousand two hundred seventeen patients were identified as having received paclitaxel or docetaxel, and 3,181 met criteria for our analysis. There were 264 (8.3%) HSRs. In adjusted multivariate analysis, we found no correlation of HSR rate or severity among any of the variables evaluated except gynecology oncology clinic patients, who had an increased risk (hazard ratio [HR] 1.34) of HSRs overall and high-grade HSRs (HR 2.34), and female patients, who had a higher rate of HSRs overall (HR 1.26), but not high-grade HSRs. CONCLUSION Neither dexamethasone dose nor route correlated with subsequent HSRs. Given the potential for adverse events from repeated high-dose steroids, our findings suggest that routine use of lower doses, such as a single 10 mg dose of dexamethasone, as premedication for taxanes to prevent HSRs is preferable to the current prescribing guidelines.
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Safety and effectiveness of tofogliflozin in Japanese patients with type 2 diabetes mellitus treated in real-world clinical practice: Results of a 36-month post-marketing surveillance study (J-STEP/LT).
Utsunomiya, K, Koshida, R, Kakiuchi, S, Senda, M, Fujii, S, Kurihara, Y, Gunji, R, Kaku, K
Journal of diabetes investigation. 2021;(2):184-199
Abstract
AIMS/INTRODUCTION Tofogliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor that lowers plasma glucose levels by enhancing urinary glucose excretion. After its approval in Japan in 2014 for the treatment of type 2 diabetes mellitus, we carried out a 3-year prospective observational post-marketing surveillance study in Japanese patients (Japanese Study of Tofogliflozin with Type 2 Diabetes Mellitus Patients/Long Term [J-STEP/LT]). MATERIALS AND METHODS This surveillance was carried out between September 2014 and February 2019, and recorded safety in terms of adverse drug reactions (ADRs) and ADRs of special interest, and effectiveness in terms of changes in glycated hemoglobin and bodyweight from baseline to last observation carried forward. RESULTS Of 6,897 patients with type 2 diabetes mellitus registered, 6,711 and 6,451 were analyzed for safety and effectiveness, respectively. ADRs were reported in 846 patients (12.61%), with serious ADRs in 101 patients (1.5%). ADRs of special interest included hypoglycemia (62 patients [0.9%]), polyuria/pollakiuria (90 [1.3%]), volume depletion-related disorders (135 [2.0%]), urinary tract infections (91 [1.4%]), genital infections (117 [1.7%]) and skin diseases (53 [0.8%]). One case of diabetic ketoacidosis was reported. The mean ± standard deviation changes from baseline to last observation carried forward in glycated hemoglobin and bodyweight were -0.68 ± 1.34% (n = 6,158, P < 0.0001) and -3.13 ± 4.67 kg (n = 5,213, P < 0.0001), respectively. CONCLUSIONS J-STEP/LT, a 3-year, prospective, observational, post-marketing study in Japan, found no unprecedented ADRs, and consistent reductions from baseline in glycated hemoglobin and bodyweight over the observation period. The present results provide further evidence regarding the safety and tolerability of tofogliflozin in Japanese patients with type 2 diabetes mellitus.
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Non-Adherence to Antihypertensive Guidelines in Patients with Asymptomatic Carotid Stenosis.
Haley, W, Shawl, F, Charles Sternbergh, W, Turan, TN, Barrett, K, Voeks, J, Brott, T, Meschia, JF
Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association. 2021;(8):105918
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IMPORTANCE Hypertension and carotid stenosis are both risk factors for stroke, but the presence of carotid stenosis might dampen enthusiasm for tight control of hypertension because of concerns for hypoperfusion. OBJECTIVE To determine the extent to which there are opportunities to potentially improve pharmacotherapy for hypertension in patients known to have asymptomatic high-grade carotid stenosis. DESIGN We examined anti-hypertensive medication prescription and adherence to evidence-based hypertension treatment guidelines in a cross-sectional analysis of baseline data of patients enrolled in a clinical trial. SETTING The Carotid Revascularization and Medical Management for Asymptomatic Carotid Stenosis Trial (CREST-2) is a multicenter prospective randomized open blinded end-point clinical trial of intensive medical management with or without revascularization by endarterectomy or stenting for asymptomatic high-grade carotid stenosis. PARTICIPANTS 1479 participants (38.6% female; mean age 69.8 years) from 132 clinical centers enrolled in the CREST-2 trial as of April 6, 2020 who were taking ≥1 antihypertensive drug at baseline. EXPOSURES Pharmacotherapy for hypertension. MAIN OUTCOME Adherence to evidence-based guidelines for treating hypertension. RESULTS Of 1458 participants with complete data, 26% were on one, 31% on 2, and 43% on ≥3 antihypertensive medications at trial entry. Thirty-two percent of participants were prescribed thiazide; 74%, angiotensin converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB); 38%, calcium channel blocker (CCB); 56%, a beta blocker; 11%, loop diuretic; and 27%, other. Of those prescribed a single antihypertensive medication, the proportion prescribed thiazide was 5%; ACEI or ARB, 55%, and CCB, 11%. The prevalence of guideline-adherent regimens was 34% (95% CI, 31-36%). CONCLUSIONS AND RELEVANCE In a diverse cohort with severe carotid disease and hypertension, non-adherence to hypertension guidelines was common. All preferred classes of antihypertensive drug were under-prescribed. Using staged iterative guideline-based care for hypertension, CREST-2 will characterize drug tolerance and stroke rates under these conditions. TRIAL REGISTRATION ClinicalTrials.gov Number NCT02089217.
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Behavioural interventions to address rational use of antibiotics in outpatient settings of low-income and lower-middle-income countries.
Nair, MM, Mahajan, R, Burza, S, Zeegers, MP
Tropical medicine & international health : TM & IH. 2021;(5):504-517
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OBJECTIVES To explore the current evidence on interventions to influence antibiotic prescribing behaviour of health professionals in outpatient settings in low-income and lower-middle-income countries, an underrepresented area in the literature. METHODS The systematic review protocol for this study was registered in PROSPERO (CRD42020170504). We searched PubMed, Embase and the Cochrane Central Register of Controlled Trials (CENTRAL) for studies relating to antibiotic prescribing of health professionals in outpatient settings in low-income and lower-middle-income countries. Behavioural interventions were classified as persuasive, enabling, restrictive, structural or bundle (mix of different interventions). In total, 3,514 abstracts were screened and 42 studies were selected for full-text review, with 13 studies included in the final narrative synthesis. RESULTS Of the 13 included studies, five were conducted in Vietnam, two in Sudan, two in Tanzania, two in India and two in Kenya. All studies were conducted in the outpatient or ambulatory setting: eight took place in primary health centres, two in private clinics and three in pharmacies. Our review found that enabling or educational interventions alone may not be sufficient to overcome the ingrained incentives to link revenue generation to sales of antibiotics, and hence, their inappropriate prescription or misuse. Bundle interventions appear to be very effective at changing prescription behaviour among healthcare providers, including drug sellers and pharmacists. CONCLUSIONS Multi-faceted bundle interventions that combine regulation enforcement with face-to-face education and peer influence may be more effective than educational interventions alone at curbing inappropriate antibiotic use.
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Profile of patients diagnosed with acute venous thromboembolism in routine practice according to age and renal function: RE-COVERY DVT/PE study.
Ageno, W, Casella, IB, Chee, KH, Schellong, S, Schulman, S, Singer, DE, Desch, M, Tang, W, Voccia, I, Zint, K, et al
Journal of thrombosis and thrombolysis. 2021;(3):561-570
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In randomized clinical trials (RCTs) of nonvitamin K antagonist oral anticoagulants (NOACs) for acute venous thromboembolism (VTE), ~ 12-13% of patients were elderly and ~ 26% had mild-to-moderate renal impairment. Observational studies are not restricted by the selection and treatment criteria of RCTs. In this ancillary analysis of the RE-COVERY DVT/PE global observational study, we aimed to describe patient characteristics, comorbidities, and anticoagulant therapy for subgroups of age (< or ≥ 75 years) and renal impairment (creatinine clearance [CrCl; estimated with Cockcroft-Gault formula] < 30 [severe], 30 to < 50 [moderate], 50 to < 80 [mild], ≥ 80 [normal] mL/min). Of 6095 eligible patients, 25.3% were aged ≥ 75 years; 38.2% (1605/4203 with CrCl values) had mild-to-moderate renal impairment. Comorbidities were more common in older patients (73.9% aged ≥ 75 vs. 58.1% < 75 years) and in those with mild or moderate versus no renal impairment (75.9%, 80.9%, and 59.3%, respectively). At hospital discharge or 14 days after diagnosis (whichever was later), most patients (53.7% and 55.1%, respectively) in both age groups received NOACs; 20.8% and 23.4%, respectively, received vitamin K antagonists, 19.0% and 21.8% parenteral therapy, 2.3% and 3.8% other anticoagulant treatments. Use of NOACs decreased with worsening renal impairment (none 58.5%, moderate 49.6%, severe 25.7%) and, in younger versus older patients with moderate renal impairment (33.1% vs. 56.1%). In routine practice, there are more elderly and renally impaired patients with VTE than represented in RCTs. Decreasing renal function, but not older age, was associated with less NOAC use. Clinical Trial Registration: http://www.clinicaltrials.gov . Unique identifier: NCT02596230. Decreasing renal function, particularly in the subgroup with CrCl < 30 mL/min, but not older age, was associated with less use of nonvitamin K antagonist oral anticoagulants (NOACs). Nevertheless, more than half of the older patients with moderate renal impairment received a NOAC as their oral anticoagulant.