Alicia Gilsenan

Attempts to quit smoking and relapse: Factors associated with success or failure from the ATTEMPT cohort study

OBJECTIVE To identify predictors of attempts to stop smoking and predictors of relapse. METHODS This study included 2431 smokers from pre-existing Internet panels in the United States, United Kingdom, Canada, France, and Spain. These panel members are Internet users who have registered voluntarily and agreed to participate in various online research studies. Respondents were aged 35-65 years, smoked >or= five cigarettes per day and intended to stop smoking in the next 3 months. They were followed every 3 months for up to 18 months via Internet contact on measures relating to quit attempts, smoking status, motivation to quit, nicotine cue, weight and weight concern, health-related factors, withdrawal symptoms, and smoking cessation aids. RESULTS In this study, recent quit attempts strongly predicted future attempts, but also predicted subsequent relapse. Motivation to quit was predictive of future attempts but not of relapse/abstinence following the attempts. Relapse to smoking was associated with nicotine dependence, exposure to smoking cues, craving, withdrawal symptoms, and lack of smoking cessation aids. CONCLUSIONS The findings lend support to a model of cessation in which level of motivation to stop generates quit attempts but plays little role in relapse. Dependence, social smoking cues, and a recently failed quit attempt are important factors in relapse.

The US postmarketing surveillance study of adult osteosarcoma and teriparatide: Study design and findings from the first 7 years

The Osteosarcoma Surveillance Study, an ongoing 15‐year surveillance study initiated in 2003, is a postmarketing commitment to the United States (US) Food and Drug Administration to evaluate a potential association between teriparatide, rhPTH(1–34), a recombinant human parathyroid hormone analog (self‐injectable medication to treat osteoporosis), and development of osteosarcoma in response to a finding from preclinical (animal) studies. Incident cases of primary osteosarcoma diagnosed in adults (aged ≥40 years) on or after January 1, 2003, are identified through population‐based state, regional, and comprehensive cancer center registries in the US. Information on possible prior treatment with teriparatide, on demographics, and on risk factors is ascertained by patient or proxy telephone interview after patient consent. Between June 2004 and September 30, 2011, 1448 cases (diagnosed 2003 to 2009) were identified by participating cancer registries (estimated to be 62% of all adult cases in the US for that time period); 549 patients or proxies were interviewed. Interviewed patients were similar to noninterviewed patients with regard to mean age, sex, race, and geographical distribution and tumor type and site of tumor. Mean age of those interviewed was 61 years, 46% were female, 86% were white, and 77% were alive when the case was reported to the study investigators. Data collected in the study provide descriptive information on a large number of adults with osteosarcoma, an uncommon malignant bone tumor. After 7 years of the study, there were no osteosarcoma patients who had a prior history of teriparatide treatment. Thus, approximately halfway through this 15‐year study, the study has not detected a pattern indicative of a causal association between teriparatide treatment and osteosarcoma in humans.

Predictors of Uncontrolled Asthma in Adult and Pediatric Patients: Analysis of the Asthma Control Characteristics and Prevalence Survey Studies (ACCESS)

Background. Despite the availability of effective asthma treatments and evidence-based management guidelines focusing on asthma control, many patients have asthma that is inadequately controlled. The objective of this analysis was to identify risk factors for uncontrolled asthma among adult and pediatric patients. Methods. Two cross-sectional surveys assessing asthma control status were conducted between January 25 and May 2, 2008, among adult and pediatric patients with asthma. Participants completed a self-administered questionnaire including demographics, medical history, and current asthma medication use. In addition, participants completed either the Asthma Control Test (ACT) or Childhood ACT (C-ACT). Uncontrolled asthma was defined as a score of ≤19 on the ACT or C-ACT. Multiple logistic regression was used to identify factors related to uncontrolled asthma. Results. A sample of 64 primary care provider sites (35 for adults and 29 for pediatric patients) across the United States enrolled. One study enrolled 2238 adults (aged ≥18 years) and the other 2429 children (aged 4–17 years) with asthma. The patients were visiting their health care provider for a scheduled appointment for any reason. The overall prevalence of uncontrolled asthma was 58% and 46% in adult and pediatric patients, respectively. Multivariate analysis identified predictors of uncontrolled asthma in both adults and children including self-reported asthma severity, lack of adherence, and recent history of cold, flu, or sinus infection. The predictors of uncontrolled asthma seen only in adults were less education, insurance status, current smoker, body mass index (BMI) >30 kg/m2, and history of gastroesophageal symptoms. The predictors of uncontrolled asthma seen only in children were female aged 12–17 years, caregiver unemployment, and history of asthma exacerbation. Conclusions. A high proportion of patients with asthma seen in primary care settings are not well controlled. Recognition of specific predictors can signal who may be at higher risk of uncontrolled asthma and provide the opportunity for early interventions.

Application of the BRAT Framework to Case Studies: Observations and Insights

The BRAT Framework is a set of flexible processes and tools that provides a structured approach to pharmaceutical benefit–risk decision making in drug development and post approval settings. A work in progress, it consists of six steps that produce representations of key tradeoffs, with appropriate documentation of the rationale for decisions and the assumptions made in their development. This article describes insights, gained from case studies, into the Frameworks performance in a variety of constructed benefit–risk scenarios, focusing on a hypothetical example of a triptan for migraine. The scenarios described illustrate the challenges inherent in arriving at many of the regulatory decisions, including obtaining data for matching populations for all outcomes, finding data of consistent quality, addressing correlated outcomes (e.g., elevated liver function tests and hepatitis rates), dealing with rare but serious adverse events (AEs), and understanding and making decisions based on information for many outcomes simultaneously. The Framework provides a structure for organizing, interpreting, and communicating relevant information, including heterogeneity in results and the quality and level of uncertainty of data, in order to facilitate benefit–risk decisions.

Status of Asthma Control in Pediatric Primary Care: Results from the Pediatric Asthma Control Characteristics and Prevalence Survey Study (ACCESS)

OBJECTIVE To estimate the prevalence of uncontrolled asthma in pediatric patients with asthma visiting their primary care provider for any medical reason. STUDY DESIGN This was a cross-sectional survey conducted at 29 pediatric care sites across the United States. Children age 4-17 years with self- or caregiver-reported asthma completed the Childhood Asthma Control Test (C-ACT) or the Asthma Control Test (ACT) and responded to demographic and health-related questions. Uncontrolled asthma was defined as a C-ACT or ACT score <or=19. RESULTS A total of 2429 children with a diagnosis of asthma (or caregivers) completed the survey. The prevalence of uncontrolled asthma was 46%. The prevalence of uncontrolled asthma was 35% in patients seen for a nonrespiratory complaint versus 54% in those seen for a respiratory complaint. Children seen for a non-respiratory-related complaint with uncontrolled asthma were more likely to have missed 1 or more school days in the previous 4 weeks compared with children with controlled asthma (53% vs 24%). CONCLUSIONS These findings highlight the impact of uncontrolled asthma not only in children seen for respiratory complaints, but also in those seen for nonrespiratory complaints. Pediatric care providers should consider evaluating asthma control on a regular basis regardless of the reason for the visit.

Assessment of asthma control in primary care

Abstract Objective: To determine the prevalence of uncontrolled asthma in patients who are visiting their primary care provider for any reason. Research design and methods: This multisite, cross-sectional survey was conducted between January 25 and May 2, 2008. Participants aged ≥18 years were recruited from 35 primary care provider sites. Eligible participants presented to the office for any acute medical, routine, follow-up, or nonmedical reason; had a self-reported physician diagnosis of asthma; used medication to treat asthma in the past year; and had no history of COPD. They completed the Asthma Control Test† (ACT) and provided information including demographics, health behaviors, medical history, and asthma medication use. Uncontrolled asthma was defined as ACT score ≤19. † Asthma Control Test is a trademark of QualityMetric, Inc., Lincoln, RI, USA. Results: The overall weighted prevalence of uncontrolled asthma in 2238 patients in primary care was 58% (95% confidence interval [CI], 0.56–0.60). Among asthma patients seeking care for a respiratory complaint, 72% (95% CI, 0.68–0.75) had uncontrolled asthma compared to 48% (95% CI, 0.45–0.51) of asthma patients presenting for a non-respiratory reason. Conclusions: At the population level, over half of patients with asthma under primary care management had uncontrolled asthma at the time of an office visit. Surprisingly, nearly 50% of patients with asthma who presented for office visits not associated with respiratory-related complaints had uncontrolled asthma. The study results may be influenced by a seasonal effect of upper respiratory infections and by the insurance status of the study respondents. However identifying patients with uncontrolled asthma is important and remains a challenge. Therefore, health care providers should consider evaluating asthma control on a regular basis, regardless of reason for visit.

Prevalence of lower urinary tract symptoms and prostate enlargement in the primary care setting.

Purpose:  Men with lower urinary tract symptoms (LUTS) from benign prostatic hyperplasia often do not discuss their symptoms with their primary care physicians (PCPs). The primary objectives of this study were to estimate the prevalence of LUTS, prostate enlargement, and prostate‐specific antigen (PSA)  ≥ 1.5 ng/ml in men visiting their PCP and to assess patients’ intent to discuss LUTS with their PCP.

Prevalence of Airway Obstruction Assessed by Lung Function Questionnaire

OBJECTIVE To estimate the prevalence of unidentified chronic obstructive pulmonary disease (COPD) and determine the screening accuracy of the Lung Function Questionnaire (LFQ). PATIENTS AND METHODS Cigarette smokers who had a smoking history of 10 or more pack-years and were aged 30 years or older were recruited from 36 centers from February 18, 2009, to May 29, 2009. A total of 1575 patients completed a Web-based survey including the 5-item LFQ. Spirometry was performed on patients with an LFQ total score of 18 or less and on a subset scoring more than 18. The primary outcome was the proportion of patients at risk of airflow obstruction as measured by the LFQ (score, ≤ 18) in whom an airflow obstruction was confirmed by spirometry. RESULTS Of the patients who completed the LFQ, 849 (54%) had standardized spirometry data available. On the basis of LFQ and spirometry results, the estimated prevalence of possible COPD was 17.9% (95% confidence interval, 15.3%-20.6%). At a cut point of 18 or less, sensitivity, specificity, positive predictive value, and negative predictive value of the LFQ were 88%, 25%, 21%, and 90%, respectively. Approximately 1 in 5 patients (21%) aged 30 years or older and 1 in 4 (26%) aged 50 years or older scored 18 or less on the LFQ and had a ratio of forced expiratory volume in the first second of expiration to forced vital capacity less than 0.70. CONCLUSION On the basis of postbronchodilator spirometry results using weighted estimates, approximately 1 in 5 patients (21%) aged 30 years or older with a smoking history of 10 or more pack-years seen in a primary care setting is likely to have COPD. The LFQ could be a helpful COPD case-finding tool for clinicians to identify patients who need further evaluation. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01013948.

Therapeutic risk management interventions: Feasibility and effectiveness

OBJECTIVE To review the effectiveness and feasibility of risk management strategies implemented for drugs with significant known risks. DATA SOURCES Published medical literature and regulatory archives, including proceedings of Food and Drug Administration advisory committee meetings. Iterative searches of the medical literature, the Internet, and Web-based government information sources were conducted throughout 2002-2003. Search terms were related to risk management, drug safety, and the names of specific medications known to be subject to risk management programs. STUDY SELECTION Key studies that illustrated examples of risk management and evaluated risk management programs were selected by the authors. DATA EXTRACTION Performed manually by the authors. DATA SYNTHESIS Much of the information regarding the effectiveness of risk management interventions in reducing risk is anecdotal; little information has been published. Given the demand for evidence-based clinical decision making, pharmaceutical manufacturers and the health care community must understand whether these programs are achieving their ultimate goals of reducing risks to patients, while making needed therapies available. This paucity of evidence points to new opportunities for researchers across disciplines to better understand the feasibility and effectiveness of these interventions and the impact of the interventions at the patient, practitioner, and public health levels. Such research needs to be published so that future programs and policy can be informed by these early examples. CONCLUSION For interventions to be effective in reducing risk, they must effect change in physician prescribing, pharmacist dispensing, and patient adherence. Risk intervention programs that are overly burdensome to physicians, pharmacists, or patients are unlikely to succeed in achieving the desired outcome of reducing individual risk. In addition, risk management programs should be scaleable and implemented in a systematic fashion to accommodate multiple simultaneous programs that can effectively manage the risk, rather than through a piecemeal approach.

Assessing Primary Care Physicians’ Beliefs and Attitudes of Asthma Exacerbation Treatment and Follow-Up

on their article [1]. The relevance of the primary care physician in the treatment of asthma, and the use of controller medications in order to prevent asthma exacerbations cannot be emphasized enough. However, we do not agree with their conclusion that healthcare providers may not share a common definition of asthma exacerbations, at least, not based on the described data. In 2009, the American Thoracic Society/European Respiratory Society presented consensus definitions for asthma exacerbations to be used in research and clinical practice [2]. In this statement, compiled by a broad clinical expert group including primary care physicians in Europe and the US, exacerbations of asthma are distinguished by severity. The definition of a severe asthma exacerbation should include at least one of the following: (a) Use of systemic corticosteroids (tablets, suspension, or injection), or an increase from a stable maintenance dose, for at least 3 days. (b) A hospitalization or ER visit because of asthma, requiring systemic corticosteroids.