Michael Manocchia

Bio: Michael Manocchia is an academic researcher from Tufts Center for the Study of Drug Development. The author has contributed to research in topics: Drug development & New drug application. The author has an hindex of 12, co-authored 17 publications receiving 1090 citations. Previous affiliations of Michael Manocchia include University of Rhode Island & Tufts University.

Linguistic and cultural barriers to care.

Abstract: CONTEXT: Primarily because of immigration, Asian Americans are one of the fastest growing and most ethnically diverse minority groups in the United States. However, little is known about their perspectives on health care quality.

Sleep problems, health-related quality of life, work functioning and health care utilization among the chronically ill

Abstract: Objectives: To provide a comprehensive assessment of whether sleep problems among the chronically ill are associated with decrements in functional health and well-being, decreases in work functioning and increases in the use of health care services. Design: Cross-sectional survey of patients from the Medical Outcomes Study (MOS), an observational study of functional health and well-being. Chronically ill patients (n = 3484) were sampled from health maintenance organizations, large multi-specialty groups, and solo or single-specialty group practices in Boston, Los Angeles, and Chicago. Chronic illness subgroups include: clinical depression (n = 527), congestive heart failure (229), diabetes (n = 577), recent myocardial infarction (n = 170), hypertension (n = 2206), asthma (n = 84), back problems (n = 771), and arthritis (n = 672). ANCOVA analyses of the relationship between sleep problems and SF-36 scales and summaries were performed. In addition, a ‘relative impact’ analysis determined what scales or summaries were most associated with sleep problems. Main outcome measures: Eight scales and two summary measures from the SF-36 Health Survey, work productivity and work quality measures and self-reports of health care utilization. Results: Comparing chronically ill patients with no sleep problems to those with mild, moderate, or severe sleep problems revealed a direct association between sleep problems and decrements in health-related quality of life (HRQOL) as measured by SF-36 scales and summaries (MANOVA F 24.1; d.f. 24; p ≤ 0.0001). In addition, significant differences in HRQOL were found when comparing patients with and without sleep problems within most of the disease groups studied. The relative impact analysis revealed that measures of mental health and the mental health summary were most associated with sleep problem severity in the total sample and chronic disease subsets, in comparison with measures of physical health. In addition, monotonic relationships were found between severity of sleep problems and decreases in work productivity and increases in health care utilization, as expected. Conclusions: The analyses revealed that sleep problems go hand in hand with poorer mental health, diminished work productivity and work quality and greater use of health care services. Sleep problems, therefore, may be a significant confounding factor in the interpretation of health outcomes among patients with chronic diseases.

Drug safety discontinuations in the United Kingdom, the United States, and Spain from 1974 through 1993: A regulatory perspective

Abstract: The objective of the present study was to compare the number of new chemical entities (NCEs) and new biologicals entities (NBEs) approved for marketing during the period 1974 through 1993 in the United Kingdom, the United States, and Spain that were subsequently discontinued (removed from the market, withdrawn, or whose license was allowed to lapse) while a question of safety existed. Of the products approved during the two decades of the study period, a total of 29 drugs were subsequently discontinued for safety reasons in at least one of the three countries (United Kingdom: 20 safety discontinuations; United States: 10; and Spain: 16). These represent 3% to 4% of all drugs introduced in these countries, an increase compared to the period from 1964 through 1983, when approximately 2% of all NCEs were discontinued for safety reasons. The therapeutic classes most commonly associated with safety discontinuations were the nonsteroidal anti-inflammatory drugs (nine drugs), vasodilators (four drugs), and antidepressants (three drugs). U.S. companies or their foreign subsidiaries were involved as originators (patent-holders and/or developers) of approximately 40% of the drugs discontinued for safety reasons.

Mobile-Web App to Self-Manage Low Back Pain: Randomized Controlled Trial

Abstract: Background: Nonspecific low back pain (NLBP) is the diagnosis for individuals with back pain that has no underlying medical cause (eg, tumor, infection, fracture, herniated disc, spinal stenosis). The American College of Physicians (ACP) and American Pain Society (APS) recommend multidisciplinary treatments for NLBP that lasts more than 4 weeks. This approach, however, is impractical for many physicians to implement, and relatively few providers offer NLBP treatment that meets the joint ACP-APS guidelines. Objective: This study evaluated the efficacy of a mobile-Web intervention called “FitBack” to help users implement self-tailored strategies to manage and prevent NLBP occurrences. Methods: A total of 597 adults were recruited, screened, consented, and assessed online at baseline, at 2 months (T2), and at 4 months (T3). After baseline assessments, participants were randomized into three groups: FitBack intervention, alternative care group that received 8 emails urging participants to link to six Internet resources for NLBP, and control group. The FitBack group also received weekly email reminder prompts for 8 weeks plus emails to do assessments. The control group was only contacted to do assessments. Results: Users of the FitBack program showed greater improvement compared to the control group in every comparison of the critical physical, behavioral, and worksite outcome measures at 4-month follow-up. In addition, users of the FitBack program performed better than the alternative care group on current back pain, behavioral, and worksite outcomes at 4-month follow-up. For example, subjects in the control group were 1.7 times more likely to report current back pain than subjects in the FitBack group; subjects in the alternative care group were 1.6 times more likely to report current back pain at 4-month follow-up. Further, the users of the FitBack program showed greater improvement compared to both the control and alternative care groups at 4-month follow-up on patient activation, constructs of the Theory of Planned Behavior, and attitudes toward pain. Conclusions: This research demonstrated that a theoretically based stand-alone mobile-Web intervention that tailors content to users’ preferences and interests can be an effective tool in self-management of low back pain. When viewed from the RE-AIM perspective (ie, reach, efficacy/effectiveness, adoption, implementation fidelity, and maintenance), this study supports the notion that there is considerable value in this type of intervention as a potentially cost-effective tool that can reach large numbers of people. The results are promising considering that the FitBack intervention was neither supported by professional caregivers nor integrated within a health promotion campaign, which might have provided additional support for participants. Still, more research is needed on how self-guided mobile-Web interventions will be used over time and to understand factors associated with continuing user engagement. Clinical Trial: Clinicaltrials.gov NCT01950091; http://clinicaltrials.gov/ct2/show/NCT01950091 (Archived by WebCite at http://www.webcitation.org/6TwZucX77). [J Med Internet Res 2015;17(1):e1]

The new drug approvals of 1990, 1991, and 1992: trends in drug development.

Abstract: Efforts to speed the development and review of new drugs have increased sharply in recent years. This report, which is the third in a series on trends in drug development, examines the new drug approvals of 1990, 1991, and 1992. During the 3-year study period, the Food and Drug Administration (FDA) approved 79 new drugs, 74 of which met the Center for the Study of Drug Development's definition of a new chemical entity (NCE). Of the 74 NCEs, 36 (49%) were considered by the FDA to represent notable therapeutic gains and were selected for "priority" review (i.e., drugs rated 1P, 1A, 1AA, and 1B), and 38 (51%) were considered to represent little or no gain and received "standard" reviews (i.e., drugs rated 1S and 1C). Investigational new drug application (IND) filing and new drug application (NDA) submission dates on all 74 drugs were obtained from responses to our manufacturer surveys as well as from FDA and public sources. The mean length of the clinical phase (IND filing to NDA submission) was 6.1 years and that of the review phase (NDA submission to approval) was 2.6 years. Of the 74 NCEs, 43 (58%) were available in foreign markets at least 1 year before U.S. approval, with a mean of 5.6 years of foreign marketing. In general, 1990 to 1992 figures are similar to those in the last half of the 1980s.

The ChEMBL database in 2017.

Abstract: ChEMBL is an open large-scale bioactivity database (https://www.ebi.ac.uk/chembl), previously described in the 2012 and 2014 Nucleic Acids Research Database Issues. Since then, alongside the continued extraction of data from the medicinal chemistry literature, new sources of bioactivity data have also been added to the database. These include: deposited data sets from neglected disease screening; crop protection data; drug metabolism and disposition data and bioactivity data from patents. A number of improvements and new features have also been incorporated. These include the annotation of assays and targets using ontologies, the inclusion of targets and indications for clinical candidates, addition of metabolic pathways for drugs and calculation of structural alerts. The ChEMBL data can be accessed via a web-interface, RDF distribution, data downloads and RESTful web-services.

Do professional interpreters improve clinical care for patients with limited english proficiency? A systematic review of the literature

Abstract: According to the 2000 Census, 47 million people in the United States speak a language other than English at home (Shin and Bruno 2003). Half of these individuals report that they speak English less than “very well.” These individuals are considered to have limited English proficiency (LEP). That is, they are not able to speak, read, write, or understand the English language at a level that permits them to interact effectively with health care providers (OCR 2002). This language barrier puts the health of many LEP individuals, and that of their communities at risk by affecting their ability to access care and communicate with their providers. It is well established that language barriers contribute to health disparities for LEP patients (Jacobs et al. 2003). These patients have less access to a usual source of care, and lower rates of physician visits and preventive services (Fox and Stein 1991; Kirkman-Liff and Mondragon 1991; Woloshin et al. 1997; Fiscella et al. 2002). Even when they do have access to care, LEP patients often have poorer adherence to treatment and follow-up for chronic illnesses, decreased comprehension of their diagnoses and treatment after emergency department (ED) visits, decreased satisfaction with care, and increased medication complications. (Manson 1988; Crane 1997; Carasquillo et al. 1999; Gandhi et al. 2000) In contrast, language concordance between patients and physicians increases patient satisfaction, patient-reported health status, and adherence with medication and follow-up visits (Manson 1988; Perez-Stable, Napoles-Springer, and Miramontes 1997; Freeman et al. 2002). Given that over 100 languages are commonly spoken in the United States, (Shin and Bruno 2003) it is often not possible to provide language concordant health care. In one study of the use of medical interpreters in urban primary care practices, physicians reported encountering 20 different languages (Karliner, Perez-Stable, and Gildengorin 2004). Although some LEP patients are fortunate enough to be seen in settings where physician and office staff speak their primary language, this language concordance can readily disappear once these patients present for laboratory testing, emergency care, or are admitted to the hospital. Therefore, the majority of providers must use other means to communicate with their LEP patients and, if they receive federal financial assistance, are required to do so by Title VI of the Civil Rights Act of 1964 (OCR 2002). Most often this means is a third person, an interpreter, who can range from a highly trained professional medical interpreter to any available bilingual person (NCIHC 2001). In their review and analysis of health plans and language assistance programs, (Brach, Fraser, and Paez 2005) recommend the use of professional interpreters to augment the use of bilingual clinicians and staff in order to improve the quality of care delivered and to decrease health disparities. A recent general review of the literature concludes that the quality of medical care is improved by either use of professional interpreters or via direct provision of care by bilingual health care providers (Flores 2005). These reviews are broad and inclusive; however, many of the studies from which they draw their conclusions combined the effects of different types of interpreters (ad hoc, trained, untrained) as well as that of language concordant clinicians without systematically distinguishing among them. Thus, we are still left with the question of the specific effect of professional interpreters on clinical care, and how their effect compares with that of ad hoc interpreters. Building on these previous reviews, we conducted a focused systematic review of the medical literature to better understand whether use of professional medical interpreters is associated with improved clinical care for LEP patients in the areas of communication errors and patient comprehension, utilization, clinical outcomes, and satisfaction.

Timing of new black box warnings and withdrawals for prescription medications.

Abstract: ContextRecently approved drugs may be more likely to have unrecognized adverse drug reactions (ADRs) than established drugs, but no recent studies have examined how frequently postmarketing surveillance identifies important ADRs.ObjectiveTo determine the frequency and timing of discovery of new ADRs described in black box warnings or necessitating withdrawal of the drug from the market.Design and SettingExamination of the Physicians' Desk Reference for all new chemical entities approved by the US Food and Drug Administration between 1975 and 1999, and all drugs withdrawn from the market between 1975 and 2000 (with or without a prior black box warning).Main Outcome MeasuresFrequency of and time to a new black box warning or drug withdrawal.ResultsA total of 548 new chemical entities were approved in 1975-1999; 56 (10.2%) acquired a new black box warning or were withdrawn. Forty-five drugs (8.2%) acquired 1 or more black box warnings and 16 (2.9%) were withdrawn from the market. In Kaplan-Meier analyses, the estimated probability of acquiring a new black box warning or being withdrawn from the market over 25 years was 20%. Eighty-one major changes to drug labeling in the Physicians' Desk Reference occurred including the addition of 1 or more black box warnings per drug, or drug withdrawal. In Kaplan-Meier analyses, half of these changes occurred within 7 years of drug introduction; half of the withdrawals occurred within 2 years.ConclusionsSerious ADRs commonly emerge after Food and Drug Administration approval. The safety of new agents cannot be known with certainty until a drug has been on the market for many years.

A Handbook for the Study of Mental Health: Social Contexts, Theories, and Systems

Abstract: We test whether significant differences in mental illness exist in a matched sample of Mental illness and the criminal justice system. In T. L. Scheid T. N. Brown (Eds.), A handbook for the study of mental health: Social contexts, theories. Find 9780521567633 A Handbook for the Study of Mental Health : Social Contexts, Theories, and Systems by Horwitz et al at over 30 bookstores. Buy, rent. A review of mental health problems in fathers following the birth of a child. for the study of mental health:Social contexts, theories, and systems (2nd ed., pp.