38 results on '"E. Pivovarova"'
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2. Test psicologici nella valutazione del rischio di violenza
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B. Rosenfeld and E. Pivovarova
- Abstract
Negli ultimi anni, per quanto concerne la valutazione del rischio, la ricerca scientifica, e con essa la letteratura clinica, si sono focalizzate quasi esclusivamente sullo sviluppo e sulla validazione di tecniche di valutazione strutturata. Eppure, nonostante la crescente attenzione riguardo la valutazione attuariale del rischio (discussa nel Cap. 2 da Monahan), la maggior parte dei medici si basa su un “giudizio” professionale strutturato o non strutturato, essenzialmente conducendo una valutazione clinica e raggiungendo cosi una conclusione a proposito del rischio di violenza. Una recente indagine condotta su psicologi forensi iscritti all’albo ha rivelato che misure formali di valutazione del rischio sono utilizzate raramente di routine (Archer et al., 2006); i valutatori forensi, invece, tendono ad inserire sempre piu test psicologici specialistici per poter ricavare tutti gli elementi importanti per una stima del rischio di violenza dell’individuo.
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- 2014
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3. Use of esters of synthetic ?,?-branched acids as the dispersion medium for complex calcium greases
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T. E. Pivovarova, Yu. L. Ishchuk, O. Ya. Krentkovskaya, S. P. Kuz'michev, I. V. Lend'el, and E. V. Lebedev
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Fuel Technology ,chemistry ,Chemical engineering ,General Chemical Engineering ,Energy Engineering and Power Technology ,chemistry.chemical_element ,Organic chemistry ,General Chemistry ,Calcium ,Dispersion (chemistry) - Published
- 1978
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4. Volatility and thermal-oxidative stability of synthetic ester oils
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E. V. Lebedev, N. A. Kholodenko, T. E. Pivovarova, and T. I. Sarnavskaya
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Fuel Technology ,Chemistry ,General Chemical Engineering ,Thermal ,Energy Engineering and Power Technology ,Organic chemistry ,General Chemistry ,Volatility (finance) ,Thermal analysis ,Stability (probability) - Abstract
1. Feasibility has been demonstrated for the use of thermal analysis in studying the thermal-oxidative stability and volatility of synthetic oils. 2. It has been established that, on the basis of their thermal-oxidative stability and volatility, esters may be recommended for use as synthetic oils operating at temperatures from 170 to 220°C.
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- 1975
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5. Modification and clearance of low density lipoproteins during the formation of endotoxin-lipoprotein complexes.
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Ya. Schvartz, L. Polyakov, M. Dushkin, and E. Pivovarova
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UNIVERSAL algebra ,GENERALIZED spaces ,MATHEMATICAL analysis ,TOPOLOGY - Abstract
Abstract Changes in electrical charge and clearance rate of LDL after the formation of their complexes with bacterial LPS were studied in experiments on Wistar rats. It was found that binding of S. minnesota R595 LPS with 125I-LDL sharply accelerated clearance of the greater part of LDL complexes, but on the other hand induced the appearance of an LDL-LPS subfraction with slower elimination rate compared to free LDL. Electrophoresis showed that after binding of LPS, LDL acquired a negative charge. These data suggest that the formation of LDL-LPS complexes is accompanied by modification of LDL due to which they acquire atherogenic properties. [ABSTRACT FROM AUTHOR]
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- 2008
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6. Influence of the unified state examination on the functional state in high school students.
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E. Pivovarova and R. Gorodnichev
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EXAMINATIONS , *PHYSIOLOGICAL stress , *PSYCHOLOGICAL stress , *HIGH school students - Abstract
Abstract The results of a local comparative experiment are presented in the course of which physiological reactions to emotional and mental stress related to the situation of taking an examination in two forms—a traditional examination and the unified state examination (USE)—were compared. It was shown that the physiological stress during the USE is slightly higher than during the traditional examination. [ABSTRACT FROM AUTHOR]
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- 2007
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7. ChemInform Abstract: CARBONYLIERUNG VON OLEFINEN MIT KOHLENMONOXID IN GEGENWART VON BORTRIFLUORID-MONOHYDRAT
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E. V. Lebedev, T. E. Pivovarova, and P. P. Gushchin
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Chemistry ,General Medicine ,Medicinal chemistry - Published
- 1972
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8. Factors affecting problem-solving court team decisions about medications for opioid use disorder.
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Andraka-Christou B, Viglione J, Ahmed F, Del Pozo B, Atkins DN, Clark MH, Totaram R, and Pivovarova E
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- Humans, Methadone therapeutic use, Male, Female, Decision Making, Problem Solving, Adult, United States, Focus Groups, Analgesics, Opioid therapeutic use, Opioid-Related Disorders psychology, Opiate Substitution Treatment, Buprenorphine therapeutic use
- Abstract
Background: Problem-solving courts (PSCs) provide alternatives to prosecution and incarceration for drug-related crimes and offer integrated support for people who have lost custody of children due to drug use. Methadone and buprenorphine are lifesaving medications for opioid use disorder (MOUD) but are underused by PSC clients. Even when PSCs lack a court-level prohibition against MOUD, court staff still make individualized decisions about whether a court client can use MOUD. Therefore, we sought to identify factors involved in such individualized PSC court decisions about clients' use of MOUD., Methods: We conducted semi-structured interviews and focus groups between Summer and Fall 2022 with a convenience sample of 54 PSC staff members from 33 courts across four states. Data were analyzed using iterative categorization., Results: Interviewees indicated that their courts had eliminated blanket prohibitions against MOUD due to federal and state policy funding requirements, widespread dissemination of voluntary best practice standards, fear of lawsuits, and MOUD education targeting courts. Courts allowed MOUD if the court client accessed it through a treatment provider with whom the court collaborates. Some courts only allowed court clients to access MOUD from non-partnering treatment providers after a court-led "vetting" process of the proposed MOUD provider. MOUD provider characteristics considered during the vetting process included the provider's willingness to communicate with the court, frequent drug testing, adjustments of medication or dosage in response to aberrant results, offering of counseling, and acceptance of Medicaid or sliding scale payments. PSC staff were least comfortable with court clients using methadone treatment., Conclusions: The presence (or lack of) a PSC-MOUD partnership is a key factor involved in court staff decisions when a court client desires MOUD. Therefore, increasing the number of partnerships between PSCs and MOUD providers could lead to higher rates of MOUD utilization. It is unclear whether court-led vetting processes for non-partnering MOUD treatment providers are necessary or appropriate, and such vetting processes could reduce treatment choice or access in communities with few MOUD providers., Competing Interests: Declaration of competing interest Authors have no conflicts of interest to declare., (Copyright © 2024 The Authors. Published by Elsevier Inc. All rights reserved.)
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- 2025
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9. Medication for Opioid Use Disorders (MOUD) Providers' Experiences with Recovery Courts: Qualitative Study of Individual and Systemic Factors Impacting Interagency Collaboration.
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Pivovarova E, Taxman FS, Boland AK, Andraka-Christou B, De La Cruz BA, Smelson D, Lemon SC, and Friedmann PD
- Abstract
Background: Recovery courts mandate substance use disorder treatment as an alternative to prosecution or incarceration but lack internal resources to offer treatment. Hence, recovery courts must rely on community-based providers to ensure access to care. Interagency collaborations between recovery courts and providers of medications for opioid use disorders (MOUD) are often challenging. This qualitative study aimed to understand community-based MOUD providers' perspectives on collaboration with recovery courts., Methods: Semi-structured, hourlong interviews were conducted with 24 providers from 11 community agencies about their experiences and perceptions of working with recovery courts. Consolidated Framework for Implementation Research informed study design, coding, and analysis., Results: At the individual-level domain, lack of knowledge about recovery courts and overall negative impressions of the criminal legal system were impediments to collaboration. Inner setting factors such as staffing shortages and provider roles in establishing therapeutic relationships limited active engagement in interagency collaboration. Outer setting domains such as communication barriers (eg, requirement of multiple release forms, lack of knowledge about who needed what information and when) and nonresponse from the courts were frequently referenced. Providers, however, also noted that direct experience with recovery court staff, especially in person, and recognition of mutual agency goals to ensure individuals receive proper care and remain in the community served as facilitators., Discussion: While interagency collaboration is essential to ensuring that individuals in recovery courts can access MOUD, providers identify individual- and system-level barriers that impact collaboration with recovery courts. Results from providers mirror findings from recovery court staff that note communication barriers, distrust toward external agencies, and limited resources for active collaboration. Findings highlight areas where implementation strategies to improve collaboration can be targeted to ensure that individuals in recovery courts can access and remain in MOUD treatment., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.
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- 2024
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10. Collaborating With Jails to Provide Community-Based Medication for Opioid Use Disorder: Qualitative Perspectives from MOUD Treatment Providers.
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Pivovarova E, Planas Garcia BY, Friedmann PD, Stopka TJ, Santelices C, and Evans EA
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Objectives: As carceral settings increasingly offer medications for opioid use disorders (MOUD), community-based providers will need to navigate relationships with correctional agencies to ensure continuity of MOUD upon release. Although collaboration has been identified as critical between agencies, limited research is available that details how providers can work with jails. We describe the perspectives of MOUD providers about their experiences collaborating with jails that had recently begun to offer MOUD., Methods: We conducted hour-long interviews with 36 MOUD providers from 18 community-based agencies. Exploration, Preparation, Implementation, and Sustainment (EPIS) concepts informed data collection and analysis., Results: MOUD providers described agency-specific (inner context) factors that facilitated collaboration, including staffing (employing staff with knowledge of co-occurring conditions) and agency culture (adaptability to change, recognition of gaps in services, being judgment-free). Providers also reported external factors as facilitators, such as broad community support of MOUD services and provision of training about MOUD to jail staff. Holding regular meetings, with a dedicated contact person, helped to overcome communication problems. However, the fragmentation of in-jail treatment services, exacerbated by jails' contracting with different healthcare providers, made it difficult to coordinate re-entry and establish agency relationships. Actively and intentionally building interagency partnerships and collaborating across interagency cultural and structural differences were bridging factors that developed and sustained collaborations., Conclusions: Our findings offer promising suggestions for establishing collaborations with carceral partners, including assessing internal agency conditions, seeking external community supports, committing to actively engaging and sustaining collaborations, and using interagency differences to develop mutually beneficial relationships., Competing Interests: Conflict of interest: None., (Copyright © 2024 American Society of Addiction Medicine.)
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- 2024
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11. Perceptions of extended-release buprenorphine among people who received medication for opioid use disorder in jail: a qualitative study.
- Author
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Stopka TJ, Rottapel R, Friedmann PD, Pivovarova E, and Evans EA
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- Humans, Male, Female, Adult, Middle Aged, Massachusetts, Jails, Prisoners, Interviews as Topic, Narcotic Antagonists administration & dosage, Narcotic Antagonists therapeutic use, Buprenorphine administration & dosage, Buprenorphine therapeutic use, Opioid-Related Disorders drug therapy, Qualitative Research, Delayed-Action Preparations, Opiate Substitution Treatment methods
- Abstract
Background: Incarceration provides an opportunity for health interventions, including opioid use disorder (OUD) treatment and prevention of opioid-related overdoses post-release. All FDA-approved forms of medication for OUD (MOUD) treatment were mandated in several Massachusetts jails in 2019, with some jails offering extended-release buprenorphine (XR-Bup). Little is known about patient perspectives on and experiences with XR-Bup in carceral settings., Methods: We conducted semi-structured interviews in 2022 with community-dwelling people who received MOUD during a recent incarceration in a Massachusetts jail. We asked participants about their experiences with and perspectives on XR-Bup while in jail. Qualitative data were double-coded deductively and reviewed inductively to identify emergent themes, which were structured using the Theoretical Framework of Acceptability (TFA)., Results: Participants (n = 38) had a mean age of 41.5 years, were 86% male, 84% White, 24% Hispanic, and 95% continued to receive MOUD at the time of their interview, including 11% receiving XR-Bup. Participants who viewed XR-Bup favorably appreciated avoiding the taste of sublingual buprenorphine; avoiding procedural difficulties and indignities associated with daily dosing in carceral settings (e.g., mouth checks, stigmatizing treatment from correctional staff); avoiding daily reminders of their addiction; experiencing less withdrawal; having extra time for other activities, such as work; and reduction of diversion of MOUD within the jail setting. Participants who viewed XR-Bup less favorably preferred to maintain their daily dosing routine; liked daily time out of their housing unit; wanted to know what was "going into my body everyday"; and feared needles and adverse events. Participants also reported that jail clinicians used XR-Bup for patients who were previously caught diverting sublingual buprenorphine, suggesting limited patient participation in decision-making around XR-Bup initiation in some jails., Conclusion: People who received MOUD in Massachusetts jails had both favorable and unfavorable views and experiences with XR-Bup. Understanding these preferences can inform protocols in jails that are considering implementation of XR-Bup treatment., (© 2024. The Author(s).)
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- 2024
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12. Diversion of medications to treat opioid use disorder: Qualitative findings from formerly incarcerated adults in Massachusetts.
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Evans EA, Pivovarova E, Senthilkumar R, Rottapel RE, Stopka TJ, Santelices C, Ferguson WJ, and Friedmann PD
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- Adult, Humans, Massachusetts, Opiate Substitution Treatment, Prisons, Buprenorphine therapeutic use, Opioid-Related Disorders drug therapy, Prisoners
- Abstract
Background: Carceral officials often cite diversion of medication for opioid use disorder (MOUD) (e.g., buprenorphine) as a reason for not offering MOUD treatment in jails and prisons with little understanding of patient perspectives. We aimed to understand patient perceptions of medication diversion from jail-based MOUD programs and the factors that contribute to and reduce diversion., Methods: We conducted thematic analyses of semi-structured interviews held in 2021-22 with 38 adults who received MOUD treatment and were released from eight Massachusetts jails that had implemented a MOUD program on or after September 2019., Results: Consistent with prior reports from carceral staff, patients perceived MOUD diversion to happen less frequently than expected, which they attributed to dosing protocols that have effectively reduced it. Patients reported that MOUD availability reduced the contraband buprenorphine market, although other contraband substances have entered jails (fentanyl, oxycodone, K2). Patients perceived Subutex to have greater misuse potential and added diversion risks. Patients valued graduated consequences and other efforts to reduce MOUD diversion and contraband for making jails safer and for enabling patients to receive treatment. Nearly all participants reported having heard about, witnessed, or been involved in actual or attempted diversion, with variation in reports by jail. Patients suggested that dispensing MOUD to all who need it immediately upon intake would be the most effective way to reduce MOUD diversion and contraband., Conclusion: Formerly incarcerated patients perceived MOUD diversion within jail medication programs as occurring less often than expected and that it can be reduced with appropriate protocols. To help limit medication diversion, patients recommended provision of MOUD upon intake to all individuals with opioid use disorder who need it. Findings have implications for MOUD program adaptation, successful routinization, and diffusion in carceral settings., Competing Interests: Declaration of Competing Interest No financial interests/personal relationships are declared. All procedures were performed in compliance with relevant laws and institutional guidelines and the appropriate institutional committee(s) have approved them. Verbal consent was obtained and the privacy rights of human participants was always observed., (Copyright © 2023 Elsevier B.V. All rights reserved.)
- Published
- 2023
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13. Facilitators and barriers to collaboration between drug courts and community-based medication for opioid use disorder providers.
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Pivovarova E, Taxman FS, Boland AK, Smelson DA, Lemon SC, and Friedmann PD
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- Humans, Methadone therapeutic use, Communication, Jails, Mental Processes, Opioid-Related Disorders drug therapy
- Abstract
Introduction: Access to medications for opioid use disorder (MOUD) is limited for individuals in drug courts - programs that leverage sanctions for mandatory substance use treatment. Drug courts rely on community agencies to provide MOUD. However, relationships with MOUD agencies, which impact access to treatment, are understudied. We examined barriers and facilitators from drug court staffs' perspectives to understand how to enhance collaborations with MOUD providers., Methods: Drug court staff (n = 21) from seven courts participated in semi-structured interviews about their experience in collaborating with MOUD providers. Interviews were informed by the Consolidated Framework for Implementation Research. Inductive (theory-based) and deductive (ground-up) approaches were used for analyses., Results: Facilitator and barrier themes centered around the needs and resources of drug court participants, external policies such MOUD access in jails, networking with external agencies, and beliefs about MOUD providers. Drug court staff preferred working with agencies that offered MOUD alongside comprehensive services. Drug courts benefited when jails offered MOUD in-house and facilitated community referrals. Existing relationships with providers and responsive communication eased referrals and served to educate the courts about MOUD. Barriers included logistical limitations (limited hours, few methadone providers) and inadequate communication patterns between providers and drug court staff. A lack of confidence in providers' prescribing practices and concerns around perceived overmedication of participants impacted referrals, interagency collaboration, and further burdened the participants., Conclusions: Collaboration between drug courts and MOUD providers was driven by patient needs, external policies, communication patterns, and perceptions. Interventions to increase access MOUD for drug court participants will need to incorporate collaboration strategies while considering the unique features of drug courts., Competing Interests: Declaration of competing interest None of the authors have any conflicts of interest to report. The views expressed in this article are those of these authors only and do not reflect the position or policies of any of the affiliated agencies., (Copyright © 2023. Published by Elsevier Inc.)
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- 2023
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14. COVID-19 impact on opioid overdose after jail release in Massachusetts.
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Friedmann PD, Dunn D, Michener P, Bernson D, Stopka TJ, Pivovarova E, Ferguson WJ, Rottapel R, Hoskinson R Jr, Wilson D, and Evans EA
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Introduction: Release from incarceration is a high-risk period for opioid overdose. Concern about COVID-19 spread in jails led to early releases; it is unknown whether pandemic era releases of persons with opioid use disorder (OUD) contributed to increases in community overdose rates., Methods: Observational data compared overdose rates three months after release among jailed persons with OUD released before (9/1/2019-3/9/2020) and during the pandemic (3/10/2020-8/10/2020) from seven jails in Massachusetts. Data on overdoses come from the Massachusetts Ambulance Trip Record Information System and Registry of Vital Records Death Certificate file. Other information came from jail administrative data. Logistic models regressed overdose on release period, controlling for MOUD received, county of release, race/ethnicity, sex, age, and prior overdose., Results: Pandemic releases with OUD had a higher risk of fatal overdose (adjusted odds ratio [aOR] 3.06; 95% CI, 1.49 to 6.26); 20 persons released with OUD (1.3%) experienced a fatal overdose within three months of release, versus 14 (0.5%) pre-pandemic. MOUD had no detectable relationship with overdose mortality. Pandemic release did not impact non-fatal overdose rates (aOR 0.84; 95% CI 0.60 to 1.18), though in-jail methadone treatment was protective (aOR 0.34; 95% CI 0.18 to 0.67)., Conclusions: Persons with OUD released from jail during the pandemic experienced higher overdose mortality compared to pre-pandemic, but the number of deaths was small. They did not experience significantly different rates of non-fatal overdose. Early jail releases during the pandemic were unlikely to explain much, if any, of the observed increase in community overdoses in Massachusetts., Competing Interests: No conflict declared., (© 2023 The Authors. Published by Elsevier B.V.)
- Published
- 2023
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15. Anticancer and antimicrobial activity of new copper (II) complexes.
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Climova A, Pivovarova E, Szczesio M, Gobis K, Ziembicka D, Korga-Plewko A, Kubik J, Iwan M, Antos-Bielska M, Krzyżowska M, and Czylkowska A
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- Humans, Ligands, Molecular Structure, Spectroscopy, Fourier Transform Infrared, Anti-Bacterial Agents pharmacology, Copper chemistry, Coordination Complexes chemistry
- Abstract
In this study, three new organic ligands N'-(benzylidene)-6-chloropyrazine-2-carbohydrazonamide (L
1 ), 6-chloro-N'-(4-nitrobenzylidene)picolinohydrazonamide(L2 ), and N'-(benzylidene)-4-chloropicolinohydrazonamide (L3 ) and three copper coordination compounds (Cu(L1 )Cl2 , Cu(L2 )Cl2 and Cu(L3 )Cl2 ) based on them were synthesized. All obtained compounds were characterized using appropriate analytical techniques: elemental analysis (EA), thermogravimetric analysis (TG-DTG), Fourier transform infrared spectroscopy (FTIR) and flame-atomic absorption spectrometry (F-AAS). These methods of physicochemical analyses helped to assume that the complexation in three cases proceeds in a bidentate manner. The X-ray investigation confirmed the synthesis pathway and molecular structures for L1 and L3 ligands. The antimicrobial activity of the obtained compounds was then comprehensively investigated, where Cu(L3 )Cl2 showed the strongest antibacterial properties against all tested bacteria (Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli). LN229 human glioma cells and BJ human normal fibroblasts cells were treated with tested compounds and their cytotoxicity was evaluated with MTT test. The effect of complexing on antitumor activity has been investigated. The ligand L1 and its complex showed similar activity against normal cells while complexation increases toxicity against cancer cells in concentrations of 50 and 100 μM. For the one pair of ligand/complex compounds the apoptosis detection, cell cycle analysis and gene expression analysis (qRT-PCR) were performed. Cu(L1 )Cl2 showed the stronger toxic effect in comparison with L1 due to the population of early apoptotic cells which revealed metabolic activity in MTT assay., Competing Interests: Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)- Published
- 2023
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16. Medication for opioid use disorder treatment continuity post-release from jail: A qualitative study with community-based treatment providers.
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Stopka TJ, Rottapel RE, Ferguson WJ, Pivovarova E, Toro-Mejias LD, Friedmann PD, and Evans EA
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- Humans, Qualitative Research, Grounded Theory, Opiate Substitution Treatment, Opiate Overdose, Drug Overdose drug therapy, Opioid-Related Disorders drug therapy, Buprenorphine
- Abstract
Background: People released from jail are at elevated opioid overdose risk. Medications for opioid use disorder (MOUD) are effective in reducing overdoses. MOUD treatment was recently mandated in seven Massachusetts jails, but little is known about barriers and facilitators to treatment continuity post-release. We aimed to assess MOUD provider perspectives on treatment continuity among people released from jail., Methods: We conducted qualitative interviews with 36 medical, supervisory, and administrative staff at MOUD programs that serve jail-referred patients. We used the Exploration, Preparation, Implementation, and Sustainment (EPIS) implementation science framework to guide development of instruments, codes, and analyses. We employed deductive and inductive coding, and a grounded theory analytical approach to identify salient themes., Results: Inner context findings highlighted necessary adjustments among jail staff to approve MOUD treatment, especially with agonist medications that were previously considered contraband. Participants perceived that some staff within jails favored abstinence-based recovery, viewing agonists as a crutch. Bridging results highlighted the importance of inter-agency communication and coordination to ensure information transfer for seamless treatment continuity in the community post-release. Pre-release planning, release on pre-scheduled dates, medication provision to cover gaps between jail release and intake at community MOUD sites, and exchange of treatment information across agencies were viewed as paramount to success. Unexpected early releases and releases from court were viewed as barriers to treatment coordination. Outer context domains were largely tied to social determinants of health. Substantial barriers to treatment continuity included shelter, food security, employment, transportation, and insurance reactivation., Conclusion: Through qualitative interviews with community-based MOUD staff, we identified salient barriers and facilitators to treatment continuity post-release from jails. Findings point to needed investments in care coordination, staffing, and funding to strengthen jail-to-community-based MOUD treatment, removing barriers to continuity, and decreasing opioid overdose deaths during this high-risk transition., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022. Published by Elsevier B.V.)
- Published
- 2022
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17. Jail-based reentry programming to support continued treatment with medications for opioid use disorder: Qualitative perspectives and experiences among jail staff in Massachusetts.
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Matsumoto A, Santelices C, Evans EA, Pivovarova E, Stopka TJ, Ferguson WJ, and Friedmann PD
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- Humans, Jails, Opiate Substitution Treatment, Massachusetts, Opioid-Related Disorders drug therapy, Drug Overdose prevention & control, Drug Overdose drug therapy, Buprenorphine therapeutic use
- Abstract
Background: Individuals with opioid use disorder released to communities after incarceration experience an elevated risk for overdose death. Massachusetts is the first state to mandate county jails to deliver all FDA approved medications for opioid use disorder (MOUD). The present study considered perspectives around coordination of post-release care among jail staff engaged in MOUD programs focused on coordination of care to the community., Methods: Focus groups and semi-structured interviews were conducted with 61 jail staff involved in implementation of MOUD programs. Interview guide development, and coding and analysis of qualitative data were guided by the Exploration, Preparation, Implementation, and Sustainment (EPIS) framework. Deductive and inductive approaches were used for coding and themes were organized using the EPIS., Results: Salient themes in the inner context focused on the elements of reentry planning that influence coordination of post-release care including timing of initiation, staff knowledge about availability of MOUD in community settings, and internal collaborations. Findings on bridging factors highlighted the importance of interagency communication to follow pre-scheduled release dates and use of bridge scripts to minimize the gap in treatment during the transition. Use of navigators was an additional factor that influenced MOUD initiation and engagement in community settings. Outer context findings indicated partnerships with community providers and timely reinstatement of health insurance coverage as critical factors that influence coordination of post-release care., Conclusions: Coordination of MOUD post-release continuity of care requires training supporting staff in reentry planning as well as resources to enhance internal collaborations and bridging partnerships between in-jail MOUD programs and community MOUD providers. In addition, efforts to reduce systemic barriers related to unanticipated timing of release and reinstatement of health insurance coverage are needed to optimize seamless post-release care., Competing Interests: Declarations of Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2022. Published by Elsevier B.V.)
- Published
- 2022
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18. Synthesis and Biological Evaluation of Thiazole-Based Derivatives with Potential against Breast Cancer and Antimicrobial Agents.
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Pivovarova E, Climova A, Świątkowski M, Staszewski M, Walczyński K, Dzięgielewski M, Bauer M, Kamysz W, Krześlak A, Jóźwiak P, and Czylkowska A
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- Anti-Bacterial Agents pharmacology, Antifungal Agents pharmacology, Female, Humans, Microbial Sensitivity Tests, Spectroscopy, Fourier Transform Infrared, Thiazoles chemistry, Anti-Infective Agents chemistry, Antineoplastic Agents pharmacology, Breast Neoplasms drug therapy
- Abstract
Investigating novel, biologically-active coordination compounds that may be useful in the design of breast anticancer, antifungal, and antimicrobial agents is still the main challenge for chemists. In order to get closer to solving this problem, three new copper coordination compounds containing thiazole-based derivatives were synthesized. The structures of the synthesized compounds and their physicochemical characterization were evaluated based on elemental analysis,
1 H andl3 C nuclear magnetic resonance (NMR), flame atomic absorption spectroscopy (F-AAS), single-crystal X-ray diffraction, thermogravimetric analysis (TGA), and Fourier-transform infrared spectroscopy (FTIR). The pharmacokinetics were studied using SwissADME. The results obtained from the computational studies supported the results obtained from the MTT analysis, and the antimicrobial activity was expressed as the minimum inhibitory concentration (MIC).- Published
- 2022
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19. Uncommon and preventable: Perceptions of diversion of medication for opioid use disorder in jail.
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Evans EA, Pivovarova E, Stopka TJ, Santelices C, Ferguson WJ, and Friedmann PD
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- Humans, Jails, Opiate Substitution Treatment, Prescription Drug Diversion prevention & control, Buprenorphine therapeutic use, Opioid-Related Disorders drug therapy
- Abstract
Introduction: Correctional officials often cite diversion of medication for opioid use disorder (MOUD) treatment (e.g., buprenorphine) as a reason for not offering MOUD treatment in jails and prisons, but it is poorly understood whether these fears are justified. We aimed to understand staff perceptions of medication diversion from jail-based MOUD programs and the factors that contribute to and prevent diversion., Methods: We conducted qualitative analyses of semi-structured in-depth interviews and focus groups performed in 2019-20 with 61 administrative, security, behavioral health, and clinical staff who implement MOUD programming in seven Massachusetts jails., Results: Contrary to staff expectations, buprenorphine diversion was perceived to occur infrequently during MOUD program implementation. The MOUD program changed staff views of buprenorphine, i.e., as legitimate treatment instead of as illicit contraband. Also, the program was perceived to have disrupted the illicit buprenorphine market in jail and reduced related coercion. Proactive strategies were essential to prevent and respond to buprenorphine diversion. Key components of diversion prevention strategies included: staff who distinguished among different reasons for diversion; comprehensive and routinized but flexible dosing protocols; communication, education, and monitoring; patient involvement in assessing reasons for diversion; and written policies to adjudicate diversion consequences., Conclusion: With appropriate protocols, buprenorphine diversion within correctional programs designed to provide MOUD treatment is perceived to be uncommon and preventable. Promising practices in program design help limit medication diversion and inform correctional officials and lawmakers as they consider whether and how to provide MOUD treatment in correctional settings., (Published by Elsevier Inc.)
- Published
- 2022
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20. New Coordination Compounds Based on a Pyrazine Derivative: Design, Characterization, and Biological Study.
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Climova A, Pivovarova E, Rogalewicz B, Raducka A, Szczesio M, Korona-Głowniak I, Korga-Plewko A, Iwan M, Gobis K, and Czylkowska A
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- Anti-Bacterial Agents chemistry, Anti-Bacterial Agents pharmacology, Cobalt chemistry, Copper chemistry, Ferric Compounds, Ligands, Manganese chemistry, Microbial Sensitivity Tests, Nickel chemistry, Pyrazines pharmacology, Coordination Complexes chemistry, Coordination Complexes pharmacology
- Abstract
New coordination compounds of Mn(II), Fe(III), Co(II), and Ni(II) and the biologically active ligand L ( N '-benzylidenepyrazine-2-carbohydrazonamide) were synthesized and characterized by appropriate analytical techniques: elemental analysis (EA), thermogravimetric analysis (TG-DTG), infrared spectroscopy (FTIR), and flame-atomic absorption spectrometry (F-AAS). The biological activity of the obtained compounds was then comprehensively investigated. Rational use of these compounds as potential drugs was proven by ADME analysis. All obtained compounds were screened in vitro for antibacterial, antifungal, and anticancer activities. Some of the studied complexes exhibited significantly higher activity than the ligand alone.
- Published
- 2022
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21. Legislatively mandated implementation of medications for opioid use disorders in jails: A qualitative study of clinical, correctional, and jail administrator perspectives.
- Author
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Pivovarova E, Evans EA, Stopka TJ, Santelices C, Ferguson WJ, and Friedmann PD
- Subjects
- Humans, Jails, Opiate Substitution Treatment, Qualitative Research, Buprenorphine therapeutic use, Drug Overdose drug therapy, Opioid-Related Disorders drug therapy
- Abstract
Background: Individuals with legal involvement and opioid use disorders (OUD) are at an increased risk of overdose and premature death. Yet, few correctional systems provide all FDA approved medications for OUD (MOUD) to all qualifying incarcerated individuals. We report on the implementation of MOUD in seven Massachusetts' jails following a state legislative mandate to provide access to all FDA-approved MOUD and to connect with treatment upon release., Methods/participants: Based on the Exploration, Preparation, Implementation, and Sustainment framework, 61 clinical, corrections, and senior jail administrators participated in semi-structured interviews and focus groups between December 2019 and January 2020. Qualitative analyses focused on external and internal contexts and bridging factors., Findings: Participants detailed how the outer context (i.e., legislative mandate) drove acceptance of MOUD and assisted with continuity of care. Salient inner context factors included decision-making around administration of agonist medications, staff perceptions and training, and changes to infrastructure and daily routines. Leadership was critical in flattening standard hierarchies and advocating for flexibility. System-based characteristics of incarcerated individuals, specifically those who were pre-sentenced, presented challenges with treatment initiation. Inter- and intra-agency bridging factors reduced duplication of effort and led to quick, innovative solutions., Conclusions: Implementation of MOUD in jails requires collaboration with and reliance on external agencies. Preparation for implementation should involve systematic reviews of available resources and connections. Implementation requires flexibility from institutional systems that are inherently rigid. Accordingly, leaders and policymakers must recognize the cultural shift inherent in such programs and allow for resources and education to assure program success., (Copyright © 2022 Elsevier B.V. All rights reserved.)
- Published
- 2022
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22. Assessing feigning with the Feigning Evaluation INtegrating Sources (FEINS) in a forensic psychiatric sample.
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Grossi LM, Green D, Cabeldue M, and Pivovarova E
- Subjects
- Humans, Male, Pilot Projects, Reproducibility of Results, Cognitive Dysfunction, Malingering diagnosis, Malingering psychology
- Abstract
Evaluators of examinees in forensic contexts must consider the potential for falsified or exaggerated psychiatric symptoms and/or cognitive deficits. A number of validated assessment tools assist evaluators in identifying those examinees who feign impairment; however, no comprehensive method has been established for consolidating data from multiple tests, interviews, behavioral observations, and collateral sources. The current pilot study preliminarily examined the interrater reliability and validity of a new forensic assessment tool, the Feigning Evaluation INtegrating Sources (FEINS), developed to guide evaluators in the comprehensive assessment of feigning by adding structure to the collection of relevant data. Fifty-eight male pretrial defendants undergoing restoration of competency to stand trial at a state forensic psychiatric center participated in the study. Results provided preliminary support for reliability in scoring the FEINS, construct validity, and predictive validity. FEINS items that assessed clinical presentation, and those that guided the use of test data, were more useful than items capturing historical/demographic data. Structured professional judgments developed using the FEINS appeared to be more accurate in predicting competency evaluators' perceptions of feigning than both unstructured clinical judgment (i.e., referring psychologist's perception of feigning) alone and test data alone, using hierarchical multiple regressions. Findings suggest that the FEINS may have practical utility in guiding clinical opinions regarding feigning across psychiatric, cognitive, and psycholegal/functional domains. (PsycInfo Database Record (c) 2022 APA, all rights reserved).
- Published
- 2022
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23. Antitumor Activity and Physicochemical Properties of New Thiosemicarbazide Derivative and Its Co(II), Ni(II), Cu(II), Zn(II) and Cd(II) Complexes.
- Author
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Rogalewicz B, Climova A, Pivovarova E, Sukiennik J, Czarnecka K, Szymański P, Szczesio M, Gas K, Sawicki M, Pitucha M, and Czylkowska A
- Subjects
- Cadmium chemistry, Copper chemistry, Humans, Ligands, Semicarbazides pharmacology, Spectrophotometry, Infrared, Zinc chemistry, Coordination Complexes chemistry, Coordination Complexes pharmacology
- Abstract
A novel biologically active thiosemicarbazide derivative ligand L ( N-[(phenylcarbamothioyl)amino]pyridine-3-carboxamide ) and a series of its five metal(II) complexes, namely: [Co(L)Cl
2 ], [Ni(L)Cl2 (H2 O)], [Cu(L)Cl2 (H2 O)], [Zn(L)Cl2 ] and [Cd(L)Cl2 (H2 O)] have been synthesized and thoroughly investigated. The physicochemical characterization of the newly obtained compounds has been performed using appropriate analytical techniques, such as1 H andl3 C nuclear magnetic resonance (NMR), inductively coupled plasma (ICP), thermogravimetric analysis (TGA), Fourier-transform infrared spectroscopy (FTIR) and magnetic measurements. In order to study the pharmacokinetic profile of the compounds, ADMET analysis was performed. The in vitro studies revealed that the synthesized compounds exhibit potent biological activity against A549 human cancer cell line.- Published
- 2022
- Full Text
- View/download PDF
24. Massachusetts Justice Community Opioid Innovation Network (MassJCOIN).
- Author
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Evans EA, Stopka TJ, Pivovarova E, Murphy SM, Taxman FS, Ferguson WJ, Bernson D, Santelices C, McCollister KE, Hoskinson R Jr, Lincoln T, and Friedmann PD
- Subjects
- Analgesics, Opioid therapeutic use, Humans, Massachusetts, Opiate Substitution Treatment, Pandemics, SARS-CoV-2, Buprenorphine therapeutic use, COVID-19, Opioid-Related Disorders drug therapy
- Abstract
A major driver of the U.S. opioid crisis is limited access to effective medications for opioid use disorder (MOUD) that reduce overdose risks. Traditionally, jails and prisons in the U.S. have not initiated or maintained MOUD for incarcerated individuals with OUD prior to their return to the community, which places them at high risk for fatal overdose. A 2018 law (Chapter 208) made Massachusetts (MA) the first state to mandate that five county jails deliver all FDA-approved MOUDs (naltrexone [NTX], buprenorphine [BUP], and methadone). Chapter 208 established a 4-year pilot program to expand access to all FDA-approved forms of MOUD at five jails, with two more MA jails voluntarily joining this initiative. The law stipulates that MOUD be continued for individuals receiving it prior to detention and be initiated prior to release among sentenced individuals where appropriate. The jails must also facilitate continuation of MOUD in the community on release. The Massachusetts Justice Community Opioid Innovation Network (MassJCOIN) partnered with these seven diverse jails, the MA Department of Public Health, and community treatment providers to conduct a Type 1 hybrid effectiveness-implementation study of Chapter 208. We will: (1) Perform a longitudinal treatment outcome study among incarcerated individuals with OUD who receive NTX, BUP, methadone, or no MOUD in jail to examine postrelease MOUD initiation, engagement, and retention, as well as fatal and nonfatal opioid overdose and recidivism; (2) Conduct an implementation study to understand systemic and contextual factors that facilitate and impede delivery of MOUDs in jail and community care coordination, and strategies that optimize MOUD delivery in jail and for coordinating care with community partners; (3) Calculate the cost to the correctional system of implementing MOUD in jail, and conduct an economic evaluation from state policy-maker and societal perspectives to compare the value of MOUD prior to release from jail to no MOUD among matched controls. MassJCOIN made significant progress during its first six months until the COVID-19 pandemic began in March 2020. Participating jail sites restricted access for nonessential personnel, established other COVID-19 mitigation policies, and modified MOUD programming. MassJCOIN adapted research activities to this new reality in an effort to document and account for the impacts of COVID-19 in relation to each aim. The goal remains to produce findings with direct implications for policy and practice for OUD in criminal justice settings., (Copyright © 2021 Elsevier Inc. All rights reserved.)
- Published
- 2021
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25. Experiences of Court Clinicians Who Perform Civil Commitment Evaluations for Substance Use Disorders.
- Author
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Christopher PP, Pridgen BE, and Pivovarova E
- Subjects
- Female, Humans, Male, Massachusetts, Pilot Projects, Risk Assessment, Commitment of Persons with Psychiatric Disorders legislation & jurisprudence, Dangerous Behavior, Health Risk Behaviors, Involuntary Commitment legislation & jurisprudence, Substance-Related Disorders therapy
- Abstract
Civil commitment for substance use disorders is an increasingly used intervention to mitigate the risks associated with severe substance use. Although court clinicians play a vital role in helping courts determine whether respondents meet statutory requirements for commitment, little is known about their experiences conducting these evaluations. In this pilot study, we surveyed all court clinicians who perform evaluations for civil commitment for substance use disorders in Massachusetts, a state with one of the highest rates of such commitments nationally. Court clinicians reported that these evaluations are most frequently ordered for individuals who use heroin and other opioids, alcohol, and cannabis. They reported a recent suicide attempt or drug overdose, intentional physical harm to another, use of dangerous weapon, and driving while intoxicated as the behaviors most likely to satisfy the statutory requirement of imminent risk. At the same time, many court clinicians consider a much broader range of behaviors as constituting imminent risk, and many reported having endorsed commitment on one or more occasions in the absence of statutory criteria being satisfied. These findings underscore the need for additional research on the performance of civil commitment evaluations for substance use disorder and standards for such evaluations., (© 2021 American Academy of Psychiatry and the Law.)
- Published
- 2021
- Full Text
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26. Reducing the Single IRB Burden: Streamlining Electronic IRB Systems.
- Author
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Murray A, Pivovarova E, Klitzman R, Stiles DF, Appelbaum P, and Lidz CW
- Subjects
- Electronics, Ethics, Research, Humans, National Institutes of Health (U.S.), Social Control, Formal, United States, Biomedical Research ethics, Ethics Committees, Research, Information Systems, Multicenter Studies as Topic
- Abstract
Electronic institutional review board systems (eIRBs) have become an integral component in ensuring compliance with Human Research Protection Program (HRPP) and IRB requirements. Despite this, few of these systems are configured to administer the single IRB (sIRB) process mandated by the National Institutes of Health (NIH) for multisite research. We interviewed 103 sIRB administrators, chairs, members, and staff members about their experiences with sIRB multisite research review. We observed three main obstacles to adapting existing eIRB systems to accommodate the sIRB process: (1) Existing systems are not designed for sIRBs and are not configured to administer sIRB responsibilities, (2) they are not interoperable, and (3) resources to improve existing systems are lacking. Our findings suggest that IRBs that act as an sIRB will need major changes to their electronic systems in order to accommodate sIRB processes. These difficulties threaten both the ability of IRBs to focus on ethical rather than bureaucratic problems and the efficiency of multisite trials.
- Published
- 2021
- Full Text
- View/download PDF
27. Impact of extended release naltrexone on health-related quality of life in individuals with legal involvement and opioid use disorders.
- Author
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Pivovarova E, Min HS, and Friedmann PD
- Subjects
- Adult, Delayed-Action Preparations therapeutic use, Humans, Injections, Intramuscular, Naltrexone therapeutic use, Narcotic Antagonists therapeutic use, Opioid-Related Disorders drug therapy, Quality of Life
- Abstract
Background: Understanding the impact of medications for opioid use disorder on health related quality of life (QOL) may help to explain why few individuals with legal involvement remain in treatment, specifically those receiving opioid antagonists. QOL is an established predictor of treatment retention and has been shown to improve with some treatment for opioid use disorder. Yet limited research has examined QOL with opioid antagonists. We examined the impact of extended release naltrexone (XR-NTX) on QOL and retention in treatment in a randomized, multi-site trial of individuals with legal involvement. Methods : The participants were 308 community-dwelling adults with current or recent legal involvement with opioid dependence at five site across United States. They were randomized to receive XR-NTX or treatment as usual for 6 months. QOL was measured every 2 weeks using Euro QOL individual items, summary index score, and health state today metric. Results : No significant difference in QOL scores were observed between the two groups at the completion of active treatment or on follow up at 52 and 78 weeks. There were no time effects of treatment on scores. Contrary to expectation, baseline and average QOL did not predict retention in treatment. Conclusion: In contrast to prior research, our findings did not demonstrate significant changes (improvements or decreases) in QOL associated with XR-NTX treatment. Clinicians may consider that individuals receiving XR-NTX may not experience changes in perceived well-being in response to treatment and consider discussing with patients that they may not necessarily perceive improvement in their QOL. This may help to ground patient's expectations about the effects of treatment and potentially reduce attrition from treatment with opioid antagonists.
- Published
- 2021
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- View/download PDF
28. When IRBs Say No to Participating in Research about Single IRBs.
- Author
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Klitzman R, Appelbaum PS, Murray A, Pivovarova E, Stiles DF, and Lidz CW
- Subjects
- Humans, Interviews as Topic, National Institutes of Health (U.S.) organization & administration, Research organization & administration, United States, Conflict of Interest, Ethics Committees, Research organization & administration, National Institutes of Health (U.S.) standards, Research standards
- Abstract
In response to a policy of the National Institutes of Health and requirements in the revised Common Rule, a protocol for a multisite study must be reviewed by a single institutional review board (IRB), rather than by the IRB at each study site. The goal of the single IRB approach is to increase the efficiency of IRB review of multisite research without jeopardizing protections for research subjects. Yet the extent to which these joint goals are being achieved is unclear. To better understand how single IRBs function, we recruited academic, government, and commercial single IRBs (N = 49) to participate in a study involving observation of protocol review meetings and/or interviews with their members, chairs, and administrators. Twenty (40.8%) agreed to participate, of which 50% agreed to both interviews and observation. While 81.8% (9/11) of academic and 50% (4/8) of government single IRBs participated in some way, only 23.3% (7/30) of commercial single IRBs did so. The four largest commercial single IRBs declined to participate. Because evaluation of single IRBs is important to inform development, implementation, monitoring, and refinement of federal policies, single IRBs should be encouraged to participate in research that examines how they function., (© 2020 by The Hastings Center. All rights reserved.)
- Published
- 2020
- Full Text
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29. In their own words: language preferences of individuals who use heroin.
- Author
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Pivovarova E and Stein MD
- Subjects
- Adult, Aged, Cross-Sectional Studies, Female, Humans, Male, Massachusetts, Middle Aged, Young Adult, Heroin Dependence rehabilitation, Inpatients psychology, Language, Patient Preference, Substance-Related Disorders rehabilitation, Terminology as Topic
- Abstract
Background and Aims: Use of non-judgmental, respectful and uniform language to describe individuals with substance use disorders (SUD) is recommended to reduce stigma. However, existing research concerning the use of labels for substance use has largely focused on perspectives of treatment providers and the general public, and to a lesser degree of those in long-term recovery. This study aimed to examine and compare labels that individuals who use heroin and are initiating SUD treatment (1) use to describe themselves and when speaking with others who use drugs, with family and with treatment providers, and (2) prefer to be called and never want to be called. Design and Setting This was a cross-sectional survey study using a convenience sample of individuals initiating an in-patient managed withdrawal program in Massachusetts, USA., Participants: Between October 2017 and May 2018, 263 participants were enrolled., Measures: Participants completed a survey about (1) what labels they used to refer to self and when talking with others who use drugs, with providers, families and at 12-Step meetings and (2) to identify which label they preferred least and most for others to use when referring to them., Findings: More than 70% of participants used the term 'addict' to describe themselves and when speaking with others. However, use of 'addict' varied by context, and was most common at 12-Step programs. Fewer than 15% reported using 'user' or slang terms, most commonly 'junkie', in any communications. The most-preferred label for others to call them was 'person who uses drugs', while the most common label that participants never wanted to be called was 'heroin misuser' or 'heroin-dependent'., Conclusion: Label preferences by individuals who use heroin and are in early recovery are consistent with general guidelines about use of first-person language and suggest avoidance of language indicative of drug misuse or dependence., (© 2019 Society for the Study of Addiction.)
- Published
- 2019
- Full Text
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30. How Single Institutional Review Boards Manage Their Own Conflicts of Interest: Findings From a National Interview Study.
- Author
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Pivovarova E, Klitzman RL, Murray A, Stiles DF, Appelbaum PS, and Lidz CW
- Subjects
- Adult, Ethics Committees, Research organization & administration, Female, Humans, Male, Middle Aged, National Institutes of Health (U.S.), Qualitative Research, United States, Young Adult, Conflict of Interest, Ethics Committees, Research ethics
- Abstract
Purpose: Conflicts of interest (COIs) are important ethical concerns because they may affect scientific decision making, research integrity, and the safety and fairness of studies. No research to date has examined COIs of single institutional review boards (sIRBs), which are now mandated by the National Institutes of Health, and will be by the revised Common Rule in 2020, for all multisite research. This study investigated how different types of sIRBs manage their own COIs by documenting existing processes for and comparing commercial, government, and academic sIRBs., Method: One hundred three personnel from 20 commercial, government, or academic sIRBs participated in semistructured interviews about their processes for and experiences with managing COIs when conducting multisite research review., Results: Variability in COI management policies exist across types of sIRBs. Commercial sIRBs were aware of their own COIs given their for-profit model, and managed them by using firewalls, relying on external reviewers, and turning down potential clients. Government sIRBs described unique COIs stemming from the same agency funding the sIRB and the research being reviewed. They addressed these by discussing concerns about COIs, using firewalls, relying on nonaffiliated reviewers, and having broad COI policies. In contrast to commercial and government sIRBs, academic sIRBs did not report any specific policies to manage their COIs, which are similar to those of local IRBs., Conclusions: As sIRBs become increasingly common, researchers will need to weigh the different COIs inherent to each type of sIRB. Additionally, academic sIRBs may consider implementing specific policies for managing their COIs.
- Published
- 2019
- Full Text
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31. Local Knowledge and Single IRBs for Multisite Studies: Challenges and Solutions.
- Author
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Klitzman R, Pivovarova E, Murray A, Appelbaum PS, Stiles DF, and Lidz CW
- Subjects
- Humans, Research Personnel, Efficiency, Organizational standards, Ethics Committees, Research, Knowledge
- Abstract
New federal policies require single IRB review for multisite studies, but many questions remain about how these IRBs will use local knowledge. The findings from our study, the first to examine how single IRBs perceive needs for local knowledge, reveal several challenges. Study respondents identified four potentially relevant types of local knowledge: about culture and linguistics, about geography and socioeconomics, about the researchers, and about the institutions. Such knowledge can potentially be obtained through local sites, but single IRBs may be unaware of potentially relevant local information, and lack of informal relationships may impede single IRBs' reviews and interactions with researchers. While a recent, commonly used, standardized single-IRB form asks three basic questions about local information, our findings suggest potential needs for additional information and, thus, have important implications for practice, policy, and research., (© 2019 by The Hastings Center. All rights reserved.)
- Published
- 2019
- Full Text
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32. Reliance agreements and single IRB review of multisite research: Concerns of IRB members and staff.
- Author
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Lidz CW, Pivovarova E, Appelbaum P, Stiles DF, Murray A, and Klitzman RL
- Subjects
- Adult, Cooperative Behavior, Female, Humans, Male, Middle Aged, Multicenter Studies as Topic, Policy Making, United States, Biomedical Research ethics, Ethics Committees, Research legislation & jurisprudence, National Institutes of Health (U.S.) ethics
- Abstract
The new National Institutes of Health (NIH) Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research was adopted primarily to simplify and speed the review of complex multisite clinical trials. However, speeding review requires overcoming a number of obstacles. Perhaps the most substantial obstacle is the time and effort needed to develop reliance agreements among the participating sites. We conducted 102 semistructured interviews with sIRB personnel, including directors, chairs, reviewers, and staff, from 20 IRBs that acted as sIRBs for multisite research, including 6 commercial/independent sIRBs, and 10 university-based academic and 4 federal sIRBs. Almost without exception, the interviewees agreed that reliance agreements were complex, difficult to develop, and time-consuming. A major problem for relying sites was that different agreements specified different responsibilities for the relying sites. Attitudes differed about whether these problems will be resolved as IRB staff and managers become more experienced with sIRBs. However it is clear that the process of developing reliance agreements must be simplified. Federal assistance in standardizing at least some sections of reliance agreements might reduce the difficulties involved.
- Published
- 2018
- Full Text
- View/download PDF
33. Single IRBs in Multisite Trials: Questions Posed by the New NIH Policy.
- Author
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Klitzman R, Pivovarova E, and Lidz CW
- Subjects
- Ethics, Research, United States, Ethics Committees, Research standards, Multicenter Studies as Topic ethics, National Institutes of Health (U.S.)
- Published
- 2017
- Full Text
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34. Is Helplessness Still Helpful in Diagnosing Posttraumatic Stress Disorder?
- Author
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Pivovarova E, Tanaka G, Tang M, Bursztajn HJ, and First MB
- Subjects
- Adult, Child, Humans, Psychological Trauma complications, Stress Disorders, Post-Traumatic etiology, Diagnostic and Statistical Manual of Mental Disorders, Psychological Trauma diagnosis, Stress Disorders, Post-Traumatic diagnosis
- Abstract
Criteria A2, experience of helplessness, fear, or horror at the time of the traumatic event, was removed from the posttraumatic stress disorder diagnosis in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. We argue that there is empirical support for retention of A2, a criterion that has clinical value and may improve diagnostic accuracy. Specifically, we demonstrate that A2 has high negative predictive power, aids in the prediction of symptom severity, and can be indispensible to detecting the disorder in children. We examine how augmenting A2 with other peritramautic emotions could improve clinical and diagnostic utility. In our opinion, rather than being eliminated, A2 needs to be reconstructed and included as one criterion of PTSD.
- Published
- 2016
- Full Text
- View/download PDF
35. Why is therapeutic misconception so prevalent?
- Author
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Lidz CW, Albert K, Appelbaum P, Dunn LB, Overton E, and Pivovarova E
- Subjects
- Comprehension, Humans, Informed Consent ethics, Clinical Trials as Topic ethics, Delivery of Health Care ethics, Ethics, Research, Human Experimentation ethics, Research Subjects, Therapeutic Misconception
- Abstract
Therapeutic misconception (TM)-when clinical research participants fail to adequately grasp the difference between participating in a clinical trial and receiving ordinary clinical care-has long been recognized as a significant problem in consent to clinical trials. We suggest that TM does not primarily reflect inadequate disclosure or participants' incompetence. Instead, TM arises from divergent primary cognitive frames. The researchers' frame places the clinical trial in the context of scientific designs for assessing intervention efficacy. In contrast, most participants have a cognitive frame that is personal and focused primarily on their medical problems. To illustrate this, we draw on interview material from both clinical researchers and participants in clinical trials. We suggest that reducing TM requires encouraging subjects to adjust their frame, not just add information to their existing frame. What is necessary is a scientific reframing of participation in a clinical trial.
- Published
- 2015
- Full Text
- View/download PDF
36. Novel and direct access to the human locomotor spinal circuitry.
- Author
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Gerasimenko Y, Gorodnichev R, Machueva E, Pivovarova E, Semyenov D, Savochin A, Roy RR, and Edgerton VR
- Subjects
- Electromyography methods, Electromyography trends, Female, Humans, Male, Young Adult, Motor Activity physiology, Nerve Net physiology, Spinal Cord physiology
- Abstract
The degree of automaticity of locomotion in primates compared with other mammals remains unclear. Here, we examine the possibility for activation of the spinal locomotor circuitry in noninjured humans by spinal electromagnetic stimulation (SEMS). SEMS (3 Hz and 1.3-1.82 tesla) at the T11-T12 vertebrae induced involuntary bilateral locomotor-like movements in the legs of individuals placed in a gravity-neutral position. The formation of locomotor-like activity during SEMS started with a latency of 0.68 +/- 0.1 s after delivering the first stimulus, unlike continuous vibration of muscles, which requires several seconds. The first EMG burst in response to SEMS was observed most often in a proximal flexor muscle. We speculate that SEMS directly activates the circuitry intrinsic to the spinal cord, as suggested by the immediate response and the electrophysiological observations demonstrating an absence of strictly time-linked responses within the EMG burst associated with individual stimuli during SEMS. SEMS in the presence of vibration of the leg muscles was more effective in facilitating locomotor-like activity than SEMS alone. The present results suggest that SEMS could be an effective noninvasive clinical tool to determine the potential of an individual to recover locomotion after a spinal cord injury, as well as being an effective rehabilitation tool itself.
- Published
- 2010
- Full Text
- View/download PDF
37. Species-specific induction of CYP2B by 2,4,6-tryphenyldioxane-1,3 (TPD).
- Author
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Pustylnyak V, Pivovarova E, Slynko N, Gulyaeva L, and Lyakhovich V
- Subjects
- Animals, Blotting, Western, DNA, Complementary metabolism, Dioxanes chemistry, Electrophoresis, Polyacrylamide Gel, Enzyme Activators chemistry, Liver enzymology, Lung drug effects, Male, Mice, Mice, Inbred C57BL, Molecular Structure, Polymerase Chain Reaction, Rats, Rats, Wistar, Species Specificity, Cytochrome P-450 CYP2B1 metabolism, Dioxanes pharmacology, Enzyme Activators pharmacology, Liver drug effects
- Abstract
Aim: The aim of the current study was to investigate the species-specific induction of CYP2B by 2,4,6-tryphenyldioxane-1,3 (TPD) in relation to activation of CAR., Main Methods: 7-Pentoxyresorufin O-dealkylase (PROD) activity, RT-PCR, Western blot, Electrophoretic mobility shift assays (EMSA)., Key Findings: Phenobarbital-like inducer administration significantly up-regulated CYP2B activity in rat and mouse liver in a species-specific manner, in contrast to the effects on CYP2B in lungs, kidneys and brains. In parallel, Western blot analysis showed that the species-specific increase of PROD in liver is related to the high content of CYP2B: phenobarbital (PB) and TPD increased CYP2B in rat liver, PB and 1,4-bis[2-(3,5-dichloropyridyloxy)]benzene (TCPOBOP) - in mouse liver. The CYP2B protein level was unchanged in the lungs of rats and mice after inducer treatment, whereas it was not detected in the kidney and brain of control and treated animals. The hepatic CYP2B activity in both species paralleled the increase of CYP2B mRNA. A detectable CYP2B mRNA level was measured in the lungs of untreated mice and rats, though it was unchanged during induction. Noninducibility of CYP2B in extrahepatic tissues accompanied an absence of constitutive androstane receptor (CAR) gene expression in these tissues. In liver CYP2B induction paralleled the high level of CAR expression detected by RT-PCR. Moreover, PB, TPD and TCPOBOP treatment stimulated nuclear accumulation of CAR and increased CAR receptor NR1-binding activity in animal liver in a species-specific manner., Significance: We have shown that the increased nuclear accumulation and binding activity of CAR are associated with the species-specific up-regulation of CYP2B by TPD in rat liver.
- Published
- 2009
- Full Text
- View/download PDF
38. Validation of an abbreviated version of the structured interview of reported symptoms in outpatient psychiatric and community settings.
- Author
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Green D, Rosenfeld B, Dole T, Pivovarova E, and Zapf PA
- Subjects
- Adult, Aged, Female, Forensic Psychiatry legislation & jurisprudence, Humans, Male, Middle Aged, Ambulatory Care Facilities, Community Mental Health Services organization & administration, Interview, Psychological, Malingering diagnosis, Malingering epidemiology
- Abstract
This study examined the effectiveness of an abbreviated version of the Structured Interview of Reported Symptoms (SIRS-A) in identifying malingered mental illness. The SIRS-A is comprised of 69 items drawn from the SIRS (R. Rogers et al. 1992, SIRS: Structured Interview of Reported Symptoms: Professional Manual. Odessa, FL: Psychological Assessment Resources, Inc.), substantially reducing the administration time. A simulation design was used with three samples; 87 psychiatric outpatients who responded honestly were compared to 29 community-dwelling adults and 24 psychiatric patients instructed to malinger psychopathology. The SIRS-A generated sensitivity comparable to or exceeding that of the SIRS normative data, but specificity was poorer; many genuinely impaired patients were misclassified as malingering. Although these findings suggest the SIRS-A may be an effective means to assess malingering in psychiatric populations, further research assessing the reasons for the elevated false positive rates is necessary.
- Published
- 2008
- Full Text
- View/download PDF
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