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- A Novel Time Series Approach to Bridge Coding Changes with a Consistent Solution Across Causes of Death. [JOURNAL ARTICLE]
- Eur J Popul 2014; 30(3):317-335.
Revisions of the International Classification of Diseases (ICD) can lead to biases in cause-specific mortality levels and trends. We propose a novel time series approach to bridge ICD coding changes which provides a consistent solution across causes of death. Using a state space model with interventions, we performed time series analysis to cause-proportional mortality for ICD9 and ICD10 in the Netherlands (1979-2010), Canada (1979-2007) and Italy (1990-2007) on chapter level. A constraint was used to keep the sum of cause-specific interventions zero. Comparability ratios (CRs) were estimated and compared to existing bridge coding CRs for Italy and Canada. A significant ICD9 to ICD10 transition occurred among 13 cause of death groups in Italy, 7 in Canada and 3 in the Netherlands. Without the constraint, all-cause mortality after the classification change would be overestimated by 0.4 % (NL), 0.03 % (Canada) and 0.2 % (Italy). The time series CRs were in the same direction as the bridge coding CRs but deviated more from 1. A smooth corrected trend over the ICD-transition resulted from applying the time series approach. Comparing the time series CRs for Italy (2003), Canada (1999) and the Netherlands (1995) revealed interesting commonalities and differences. We demonstrated the importance of adding the constraint, the validity of our methodology and its advantages above earlier methods. Applying the method to more specific causes of death and integrating medical content to a larger extent is advocated.
- Osteoporosis medication dispensing for older Australian women from 2002 to 2010: influences of publications, guidelines, marketing activities and policy. [JOURNAL ARTICLE]
- Pharmacoepidemiol Drug Saf 2014 Aug 30.
Developments in anti-osteoporosis medications (AOMs) have led to changes in guidelines and policy, which, along with media and marketing strategies, have had an impact upon the prescribing of AOM. The aim was to examine patterns of AOM dispensing in older women (aged 76-81 years at baseline) from 2002 to 2010.Administrative claims data were used to describe AOM dispensing in 4649 participants (born in 1921-1926 and still alive in 2011) in the Australian Longitudinal Study on Women's Health. The patterns were interpreted in the context of changes in guidelines, indications for subsidy, publications (scholarly and general media), and marketing activities.Total use of AOM increased from 134 DDD/1000/day in 2002 to 216 DDD/1000/day in 2007 but then decreased to 184 DDD/1000/day in 2010. Alendronate was the most commonly dispensed AOM but decreased from 2007, while use of risedronate (2002 onward), strontium ranelate (2007 onward) and zoledronic acid (2008 onward) increased. Etidronate and hormone replacement therapy (HRT) prescriptions gradually decreased over time. The decline in alendronate dispensing coincided with increases of other bisphosphonates and publicity about potential adverse effects of bisphosphonates, despite relaxing indications for bone density testing and subsidy for AOM.Overall dispense of AOM from 2002 reached a peak in 2007 and thereafter declined despite increases in therapeutic options and improved subsidised access. The recent decline in overall AOM dispensing seems to be explained largely by negative publicity rather than specific changes in guidelines and policy. Copyright © 2014 John Wiley & Sons, Ltd.
- Antihypertensive treatment and blood pressure control relative to hypertension treatment guidelines. [JOURNAL ARTICLE]
- Pharmacoepidemiol Drug Saf 2014 Aug 29.
To describe initial antihypertensive management relative to important aspects of JNC7 hypertension guidelines, to identify predictors of receiving JNC7 discordant therapy, and to determine the association between receiving JNC7-concordant antihypertensive treatment and achieving blood pressure (BP) control. This study focused on aspects of the JNC7 guidelines which are consistent with other guidelines that have been published since JNC7.EMR data from eleven multi-specialty medical groups in the US were retrospectively collected between 2008-2011. The study cohort included incident hypertensive patients who received an antihypertensive prescription during the 6-month follow-up period. Patients with existing hypertension were excluded. JNC7-concordance of the prescribed antihypertensive regimen was evaluated. Using multivariable logistic regression, we determined the association between JNC7-concordance and achieving BP control. Additionally, we determined predictors of receiving JNC7-discordant treatment.14,910 incident hypertensive patients who were treated with an antihypertensive during the 6-month follow-up period were included. Overall, 79.4% patients were prescribed antihypertensive therapy concordant with JNC7; however among patients with stage 2 hypertension, the concordance was found to be 50%. BP control was achieved by 64.1% and 48.5% of patients who received JNC7-concordant and JNC7-discordant therapy, respectively. The overall adjusted odds ratio (95% CI) for BP control and JNC7-concordance was 1.53 (1.40, 1.68). The association was attenuated for cohort members with diabetes, chronic kidney disease (CKD), and stage 2 hypertension. Predictors of receiving JNC7-discordant therapy were congestive heart failure, CKD, and diabetes.JNC7-concordance is high overall, but drops substantially when JNC7 recommendations are more demanding (e.g., among patients with stage 2 hypertension and/or CKD, CHF, diabetes). Overall, patients who are prescribed an antihypertensive regimen that is JNC7-concordant are more likely to achieve BP control. Copyright © 2014 John Wiley & Sons, Ltd.
- Atomoxetine in the treatment of attention deficit hyperactivity disorder and suicidal ideation. [JOURNAL ARTICLE]
- Expert Opin Drug Saf 2014 Sep; 13(S1):69-78.
Objective: Attention deficit hyperactivity disorder (ADHD) is the most common psychiatric childhood disorder. The most commonly used drugs in the treatment of ADHD are methylphenidate (MPH) and atomoxetine (ATX); the former of the two is prescribed in USA more than it is in Western Europe. Some of the most important safety concerns about ADHD drug treatment are sudden cardiac death and suicidal behavior. In this study, we present a series of cases of Italian children who had presented suicidal ideation during ADHD pharmacological therapy with ATX. Research design and methods: Data were obtained from the ADHD Italian Register. The data assessed the use of MPH and ATX, which had been prescribed to patients who were aged < 18 years and diagnosed with ADHD. All patients enrolled in the ADHD Italian Register treated with ATX or MPH who experienced suicidal thoughts or thoughts of self-harming were considered and assessed. Results: We describe the clinical cases of seven Italian children (enrolled in the ADHD Italian Register) treated with ATX and affected by suicidal ideation, self-harming or other similar symptoms. Our results highlighted that all seven patients developed suicidal ideation or intentional self-harming during pharmaceutical treatment with ATX and, particularly, after the dose increase of the drug. Conclusion: There is a need to improve our knowledge about the efficacy and safety of ATX, MPH and other drugs used in the treatment of ADHD both in children and adults during the post-marketing experience.
- Bisphosphonate-related osteonecrosis of the jaw: an Italian post-marketing surveillance analysis. [JOURNAL ARTICLE]
- Expert Opin Drug Saf 2014 Sep; 13(S1):31-40.
Objective: Although bisphosphonate (BP)-related osteonecrosis of the jaw (BRONJ) is well recognized, little is known about it in terms of pathophysiology, epidemiology or management. We analyzed all suspected BRONJ reports sent to the Italian Pharmacovigilance Adverse Event Spontaneous Reporting System (Rete Nazionale Farmacovigilanza [RNF]) to determine their pattern and add new information about this relevant issue. Research design and methods: All suspected BRONJ sent to the RNF between 2003 and 2011 were retrieved. After a case-by-case assessment procedure, we analyzed BP type, BP exposure time and time since last use. Results: Between 2003 and 2011, 555 reports of osteonecrosis of the jaw (ONJ) after BP administration were recorded in the RNF. These events occurred mostly in patients affected by cancer (77.84%) in which zoledronate was the most frequently suspected BP. Most patients experienced ONJ after long-term use of the drug (median time of BP exposure being between 1.3 and 8.8 years). Interestingly, 139 (25.05%) cases of ONJ occurred between 2 and 121 months after BP withdrawal. Conclusion: This study shows that BRONJ can occur much earlier than hitherto reported, adds new data on BRONJ onset following ibandronate treatment and reveals that patients who cease BP-based therapy develop ONJ, raising the question of post-treatment monitoring strategies.
- Improvement of patient adverse drug reaction reporting through a community pharmacist-based intervention in the Campania region of Italy. [JOURNAL ARTICLE]
- Expert Opin Drug Saf 2014 Sep; 13(S1):21-29.
Objective: Adverse drug reaction (ADR) reporting by patients has a fundamental role in pharmacovigilance. The main objectives of the present study were to assess the impact of a pharmacist-based intervention in promoting direct patient reporting, to evaluate patient ability to identify and report ADRs and to determine their pattern. Research design and methods: The study involved 96 pharmacists in the Campania region of Italy, who interviewed their customers and asked them whether they had experienced an ADR. Patients who had experienced an ADR were invited to complete an ADR reporting form. The quality of completed ADR reporting forms was evaluated before their entry into the Italian Spontaneous Reporting System (Rete Nazionale di Farmacovigilanza [RNF]) and, once entered, their pattern was determined. Results: A total of 18,677 patients were interviewed, and 10.88% had experienced an ADR. After quality control, 54.32% of all reporting forms were entered into the RNF so that patient contribution to spontaneous reporting, null over the years, reached ∼7%. Patients reported mainly non-serious (91.28%) and expected (94.62%) ADRs, and NSAIDs or antibiotics were the most frequently reported drugs. Conclusions: The study shows that pharmacists can have an important role in promoting patient reporting and adds new information on how a patient reporting form should be structured.
- Pediatric drug safety surveillance in Italian pharmacovigilance network: an overview of adverse drug reactions in the years 2001 - 2012. [JOURNAL ARTICLE]
- Expert Opin Drug Saf 2014 Sep; 13(S1):9-20.
Objective: To describe the characteristics of pediatric adverse drug reactions (ADRs) reported in Italian spontaneous reporting database. Methods: Reports of suspected ADRs related to children and adolescents were extracted from 2001 - 2012. After exclusion of duplicates, vaccines and reports containing missing age data, the report characteristics were investigated in terms of implicated drug and adverse drug event across different age-categories. Results: Among 123,129 selected reports, 8338 (6.8%) concerned pediatrics. Of these, 52.2% involved male patients compared to 47.5% female up to the age of 11. After the age of 11 this statistic reversed. 39.4% of pediatric reports were serious and of these, 75.2% required hospitalization mainly in very young children. Most of reports were issued by hospital physicians (61.9%), followed by pharmacists (10.1%), while reports from family pediatricians accounted for 8.1%. The most frequently implicated drug categories were anti-infectives for systemic use (44.9%), drugs for the nervous system (15.6%), and anti-inflammatory drugs (10.2%). The most frequently suspected compounds differed between children and adults and reports for the same drug were likely to be more serious in adults than in children. Conclusions: This ADR reporting system reflects real safety concerns for drugs used in children and emphasizes the need for stratifying analyses by age-subgroup to increase the sensitivity of signal detection procedure.
- Chemoradiotherapy with capecitabine for locally advanced anal carcinoma: an alternative treatment option. [JOURNAL ARTICLE]
- Br J Cancer 2014 Aug 28.
Background:Capecitabine is an established treatment alternative to intravenous 5-fluorouracil (5-FU) for patients with rectal cancer receiving chemoradiotherapy. Its place in the treatment of locally advanced anal carcinoma (AC), however, remains undetermined. We investigated whether capecitabine is as effective as 5-FU in the treatment of patients with locally advanced AC.Methods:One hundred and five patients with squamous cell AC stage T2-4 (T2>4 cm), N0-1, M0 or T1-4, N2-3, M0, were included in this retrospective study. Forty-seven patients were treated with continuous 5-FU (750 mg m(-2)) on days 1-5 and 29-33, mitomycin C (MMC, 10 mg m(-2)) on day 1, and radiotherapy; 58 patients were treated with capecitabine (825 mg m(-2) b.i.d. on weekdays), MMC (10 mg m(-2)) on day 1, and radiotherapy. The primary end points of the study were: clinical complete response rate, locoregional control (LRC) and overall survival (OS). Secondary end points were: colostomy-free survival (CFS), toxicity and associations of genetic polymorphisms (GSTT1, GSTM1, GSTP1 and TYMS) with outcome and toxicity.Results:Clinical complete response was achieved in 41/46 patients (89.1%) with 5-FU and in 52/58 patients (89.7%) with capecitabine. Three-year LRC was 76% and 79% (P=0.690, log-rank test), 3-year OS was 78% and 86% (P=0.364, log-rank test) and CFS was 65% and 79% (P=0.115, log-rank test) for 5-FU and capecitabine, respectively. GSTT1 and TYMS genotypes were associated with severe (grade 3-4) toxicity.Conclusions:Capecitabine combined with MMC and radiotherapy was equally effective as 5-FU-based chemoradiotherapy. This study shows that capecitabine can be used as an acceptable alternative to 5-FU for the treatment of AC.British Journal of Cancer advance online publication 28 August 2014; doi:10.1038/bjc.2014.467 www.bjcancer.com.
- Patterns of Second-Line Uterotonic Use in a Large Sample of Hospitalizations for Childbirth in the United States: 2007-2011. [JOURNAL ARTICLE]
- Anesth Analg 2014 Aug 27.
The incidence of postpartum hemorrhage due to uterine atony has increased significantly in the United States during the past decade. For patients with refractory uterine atony after oxytocin administration, second-line uterotonics including methylergonovine maleate, carboprost, and misoprostol are recommended. In this study, we describe hospital-level patterns of second-line uterotonic use in a large, nationwide sample of admissions for childbirth in the United States.The Premier Research Database was used to define a cohort of 2,180,916 patients hospitalized for delivery at 1 of 367 hospitals from 2007 to 2011. Mixed-effects logistic regression models were used to estimate the hospital-specific frequency of second-line uterotonic use adjusting for measured patient-level and hospital-level characteristics that might be risk factors for uterine atony.The median hospital-level frequency of second-line uterotonic use was 7.1% (interquartile range 5.2-% to 10.8%). In the fully adjusted model, the mean (SE) predicted probability of second-line uterotonic use was 7.02% (0.26%), with 95% of the hospitals having a predicted (SE) probability between 1.69% (0.12%) and 24.96% (1.28%).We observed wide interhospital variation in the use of second-line uterotonics that was not explained by patient-level or hospital-level characteristics. Studies aimed at defining the optimal pharmacologic strategies for the management of uterine atony are needed, particularly in light of the increasing incidence of atonic postpartum hemorrhage in the United States and other developed countries.
- Reply. [JOURNAL ARTICLE]
- Obstet Gynecol 2014 Sep; 124(3):638.