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CHARTing a Path to Pragmatic Tobacco Treatment Research

Cruvinel, Erica; Richter, Kimber P; Stoney, Catherine; Duffy, Sonia; Fellows, Jeffrey; Harrington, Kathleen F; Rigotti, Nancy A; Sherman, Scott; Tindle, Hilary A; Shireman, Theresa I; Shelley, Donna; Waiwaiole, Lisa; Cummins, Sharon
INTRODUCTION: It is important to consider the degree to which studies are explanatory versus pragmatic to understand the implications of their findings for patients, healthcare professionals, and policymakers. Pragmatic trials test the effectiveness of interventions in real-world conditions; explanatory trials test for efficacy under ideal conditions. The Consortium of Hospitals Advancing Research on Tobacco (CHART) is a network of seven NIH-funded trials designed to identify effective programs that can be widely implemented in routine clinical practice. METHODS: A cross-sectional analysis of CHART trial study designs was conducted to place each study on the pragmatic-explanatory continuum. After reliability training, six raters independently scored each CHART study according to ten PRagmatic Explanatory Continuum Indicator Summary (PRECIS) dimensions, which covered participant eligibility criteria, intervention flexibility, practitioner expertise, follow-up procedures, participant compliance, practitioner adherence, and outcome analyses. Means and SDs were calculated for each dimension of each study, with lower scores representing more pragmatic elements. Results were plotted on "spoke and wheel" diagrams. The rating process and analyses were performed in October 2014 to September 2015. RESULTS: All seven CHART trials tended toward the pragmatic end of the spectrum, although there was a range from 0.76 (SD=0.23) to 1.85 (SD=0.58). Most studies included some explanatory design elements. CONCLUSIONS: CHART findings should be relatively applicable to clinical practice. Funders and reviewers could integrate PRECIS criteria into their guidelines to better facilitate pragmatic research. CHART study protocols, coupled with scores reported here, may help readers improve the design of their own pragmatic trials.
PMCID:5919279
PMID: 27647063
ISSN: 1873-2607
CID: 2254212

A randomized trial comparing the effect of nicotine versus placebo electronic cigarettes on smoking reduction among young adult smokers

Tseng, Tuo-Yen; Ostroff, Jamie S; Campo, Alena; Gerard, Meghan; Kirchner, Thomas; Rotrosen, John; Shelley, Donna
INTRODUCTION: Electronic cigarette (EC) use is growing dramatically with use highest among young adults and current smokers. One of the most common reasons for using ECs is interest in quitting or reducing cigarettes per day (CPD); however there are few randomized controlled trials (RCT) on the effect of ECs on smoking abstinence and reduction. METHODS: We conducted a two-arm; double-blind RCT. Subjects were randomized to receive 3-weeks of either disposable 4.5% nicotine EC (intervention) or placebo EC. The primary outcome was self-reported reduction of >/=50% in the number of CPDs smoked at week 3 (end of treatment) compared to baseline. Study subjects (n=99) were young adult (21-35), current smokers (smoked >/=10 CPDs) living in NYC. RESULTS: Compared with baseline, a significant reduction in CPDs was observed at both study time periods (1 and 3 weeks) for intervention (p<.001) and placebo (p<.001) groups. Between-group analyses showed significantly fewer CPDs in the intervention group compared to the placebo group at week 3 (p=.03), but not at any other follow-up periods. The logistic regression analysis showed that using a greater number of ECs, treatment condition and higher baseline readiness to quit were significantly associated with achieving >/=50% reduction in CPDs at the end of treatment. CONCLUSION: A diverse young adult sample of current everyday smokers, who were not ready to quit, was able to reduce smoking with the help of ECs. Further study is needed to establish the role of both placebo and nicotine containing ECs in increasing both reduction and subsequent cessation.
PMCID:5016841
PMID: 26783292
ISSN: 1469-994x
CID: 1922122

Staff Satisfaction, Ethical Concerns, and Burnout in the New York City Jail Health System

Kalra, Ramneet; Kollisch, Sarah Glowa; MacDonald, Ross; Dickey, Nathaniel; Rosner, Zachary; Venters, Homer
This article reviewed a program evaluation conducted among correctional health care staff in New York City (NYC) using a 68-question electronic survey to assess satisfaction, attitudes, and beliefs in relation to ethics and burnout of health care employees in NYC jails. Descriptive statistics were tabulated and reviewed, and further assessment of burnout and ethics was performed through group sessions with participants. This evaluation has led to changes in agency policies and procedures and an emphasis on the human rights issue of the dual loyalty challenges that the security setting places on the overall mission to care for patients.
PMID: 27742860
ISSN: 1940-5200
CID: 2309452

Pain and Functional Status in Patients With Ventricular Assist Devices

Weerahandi, Himali; Goldstein, Nathan; Gelfman, Laura P; Jorde, Ulrich; Kirkpatrick, James N; Marble, Judith; Naka, Yoshifumi; Pinney, Sean; Slaughter, Mark S; Bagiella, Emilia; Ascheim, Deborah D
CONTEXT: Ventricular assist devices (VADs) have been shown to improve survival and overall quality of life, but there are limited data on pain control and functional status in this patient population. OBJECTIVES: This study examined changes in pain, functional status, and quality of life over time in VAD patients. METHODS: Patients were enrolled in this prospective cohort study before or as early after VAD implant as possible and then followed for up to 48 weeks. The Brief Pain Inventory was used to assess pain. The Katz Independent Activities of Daily Living questionnaire was used to assess functional status. The Kansas City Cardiomyopathy Questionnaire, a 23-item questionnaire covering five domains (physical function, symptoms, social function, self-efficacy, and quality of life), was used to assess quality of life and health status. RESULTS: Eighty-seven patients were enrolled at four medical centers. The median Brief Pain Inventory severity score was 2.8 (interquartile range 0.5-5.0) before implantation and 0.0 (interquartile range 0.0-5.3) 48 weeks after implantation (P = 0.0009). Katz Independent Activities of Daily Living summary scores also demonstrated significant improvement over time (P < 0.0001). Kansas City Cardiomyopathy Questionnaire summary scales demonstrated significant improvement with time (P < 0.0016). CONCLUSION: This study demonstrated that patients with VADs experienced improved pain, functional status, and quality of life over time. These data may be useful to help patients make decisions when they are considering undergoing VAD implantation.
PMCID:5897591
PMID: 27401516
ISSN: 1873-6513
CID: 2320512

Racial and Ethnic Differences in Injury Prevention Behaviors Among Caregivers of Infants

Heerman, William J; Perrin, Eliana M; Sanders, Lee M; Yin, H Shonna; Coyne-Beasley, Tamera; Bronaugh, Andrea B; Barkin, Shari L; Rothman, Russell L
INTRODUCTION: African American and Latino children experience higher rates of traumatic injury and mortality, but the extent to which parents of different races and ethnicities disparately enact injury prevention behaviors has not been fully characterized. The objective of this study is to evaluate the association between caregiver race/ethnicity and adherence to injury prevention recommendations. METHODS: This was a cross-sectional analysis of caregiver-reported baseline data from the Greenlight study, a cluster-randomized pediatric obesity prevention trial. Data were collected between 2010 and 2012 in four academic pediatric practices and analyzed in 2015. Non-adherence to injury prevention recommendations was based on five domains: car seat safety, sleeping safety, fire safety, hot water safety, and fall prevention. RESULTS: Among 864 caregiver-infant pairs (17.7% white, non-Hispanic; 49.9% Hispanic; 27.7% black, non-Hispanic; 4.7 % other, non-Hispanic), mean number of non-adherent injury prevention behaviors was 1.8 (SD=0.9). In adjusted regression, Hispanic caregivers had higher odds of non-adherence to car seat safety (AOR=2.1, 95% CI=1.2, 3.8), and lower odds of non-adherence with fall prevention (AOR=0.4, 95% CI=0.3, 0.7) compared with whites. Black, non-Hispanic caregivers had higher odds of non-adherence to car seat safety (AOR=2.4, 95% CI=1.3, 4.4) and sleeping safety (AOR=2.1, 95% CI=1.3, 3.2), but lower odds of fall prevention non-adherence (AOR=0.5, 95% CI=0.3, 0.8) compared with whites. CONCLUSIONS: A high prevalence of non-adherence to recommended injury prevention behaviors is common across racial/ethnic categories for caregivers of infants among a diverse sample of families from low-SES backgrounds.
PMCID:5477236
PMID: 27291075
ISSN: 1873-2607
CID: 2144922

Neighborhood Socioeconomic Disadvantage; Neighborhood Racial Composition; and Hypertension Stage, Awareness, and Treatment Among Hypertensive Black Men in New York City: Does Nativity Matter?

Cole, Helen; Duncan, Dustin T; Ogedegbe, Gbenga; Bennett, Samantha; Ravenell, Joseph
OBJECTIVE: Neighborhood-level poverty and racial composition may contribute to racial disparities in hypertension outcomes. Little is known about how the effects of neighborhood social environments may differ by nativity status among diverse urban Black adults. We aimed to characterize the influence of neighborhood-level socio-demographic factors on hypertension outcomes among US- and foreign-born Black men with uncontrolled blood pressure. DESIGN: We conducted a cross-sectional analysis of baseline data from two large community-based trials of hypertensive Black men aged 50 and over linked with census tract data from the 2012 American Community Survey 5-year estimates. We defined census tracts with high racial segregation as those where 60 % or more self-identified as Black and high-poverty census tracts as those where 20 % or more lived below the poverty line. Multivariable general estimating equation models were used to measure associations between neighborhood characteristics and stage of hypertension, hypertension awareness, and treatment to yield adjusted prevalence ratios (aPR). Models were run separately for US- and foreign-born Black men. RESULTS: Over 64 % of the 1139 participants lived in a census tract with a high percentage of Black residents and over 71 % lived in high-poverty census tracts. Foreign-born Black men living in neighborhoods with a high concentration of Black residents were less likely to be treated for their high blood pressure (aPR 0.44, 95 % CI 0.22-0.88), but this result did not hold for US-born Black men. There were no significant associations between neighborhood poverty and hypertension outcomes. CONCLUSIONS: Neighborhood context may impact treatment for hypertension, one of the most important factors in hypertension control and decreasing hypertension-related mortality, particularly among foreign-born Black men.
PMCID:5362363
PMID: 27659485
ISSN: 2196-8837
CID: 2254962

Preparedness of HIV care and treatment clinics for the management of concomitant non-communicable diseases: a cross-sectional survey

Leung, Claudia; Aris, Eric; Mhalu, Aisa; Siril, Hellen; Christian, Beatrice; Koda, Happiness; Samatta, Talumba; Maghimbi, Martha Tsere; Hirschhorn, Lisa R; Chalamilla, Guerino; Hawkins, Claudia
BACKGROUND:In Sub-Saharan Africa, epidemiological studies have reported an increasing burden of non-communicable diseases (NCD) among people living with HIV. NCD management can be feasibly integrated into HIV care; however, clinic readiness to provide NCD services in these settings should first be assessed and gaps in care identified. METHODS:A cross-sectional survey conducted in July 2013 assessed the resources available for NCD care at 14 HIV clinics in Dar es Salaam, Tanzania. Survey items related to staff training, protocols, and resources for cardiovascular disease risk factor screening, management, and patient education. RESULTS:43 % of clinics reported treating patients with hypertension; however, only 21 % had a protocol for NCD management. ECHO International Health standards for essential clinical equipment were used to measure clinic readiness; 36 % met the standard for blood pressure cuffs, 14 % for glucometers. Available laboratory tests for NCD included blood glucose (88 %), urine dipsticks (78 %), and lipid panel (57 %). 21 % had a healthcare worker with NCD training. All facilities provided some form of patient education, but only 14 % included diabetes, 57 % tobacco cessation, and 64 % weight management. CONCLUSIONS:A number of gaps were identified in this sample of HIV clinics that currently limit the ability of Tanzanian healthcare workers to diagnose and manage NCD in the context of HIV care. Integrated NCD and HIV care may be successfully achieved in these settings with basic measures incorporated into existing infrastructures at minimal added expense, i.e., improving access to basic functioning equipment, introducing standardized treatment guidelines, and improving healthcare worker education.
PMCID:5031255
PMID: 27655406
ISSN: 1471-2458
CID: 5273092

Proceedings of the 13th annual conference of INEBRIA

Watson, Rod; Morris, James; Isitt, John; Barrio, Pablo; Ortega, Lluisa; Gual, Antoni; Conner, Kenneth; Stecker, Tracy; Maisto, Stephen; Paroz, Sophie; Graap, Caroline; Grazioli, Véronique S; Daeppen, Jean-Bernard; Collins, Susan E; Bertholet, Nicolas; McNeely, Jennifer; Kushnir, Vlad; Cunningham, John A.; Crombie, Iain K; Cunningham, Kathryn B; Irvine, Linda; Williams, Brian; Sniehotta, Falko F; Norrie, John; Melson, Ambrose; Jones, Claire; Briggs, Andrew; Rice, Peter; Achison, Marcus; McKenzie, Andrew; Dimova, Elena; Slane, Peter W; Grazioli, Véronique S.; Collins, Susan E.; Paroz, Sophie; Graap, Caroline; Daeppen, Jean-Bernard; Baggio, Stéphanie; Dupuis, Marc; Studer, Joseph; Gmel, Gerhard; Magill, Molly; Grazioli, Véronique S.; Tait, Robert J.; Teoh, Lucinda; Kelty, Erin; Geelhoed, Elizabeth; Mountain, David; Hulse, Gary K.; Renko, Elina; Mitchell, Shannon G.; Lounsbury, David; Li, Zhi; Schwartz, Robert P.; Gryczynski, Jan; Kirk, Arethusa S.; Oros, Marla; Hosler, Colleen; Dusek, Kristi; Brown, Barry S.; Finnell, Deborah S.; Holloway, Aisha; Wu, Li-Tzy; Subramaniam, Geetha; Sharma, Gaurav; Wallhed Finn, Sara; Andreasson, Sven; Dvorak, Robert D.; Kramer, Matthew P.; Stevenson, Brittany L.; Sargent, Emily M.; Kilwein, Tess M.; Harris, Sion K.; Sherritt, Lon; Copelas, Sarah; Knight, John R.; ,; Mdege, Noreen D; McCambridge, Jim; Bischof, Gallus; Bischof, Anja; Freyer-Adam, Jennis; Rumpf, Hans-Juergen; Fitzgerald, Niamh; Schölin, Lisa; Toner, Paul; Böhnke, Jan R.; Veach, Laura J.; Currin, Olivia; Dongre, Leigh Z.; Miller, Preston R.; White, Elizabeth; Williams, Emily C.; Lapham, Gwen T.; Bobb, Jennifer J.; Rubinsky, Anna D.; Catz, Sheryl L.; Shortreed, Susan; Bensley, Kara M.; Bradley, Katharine A.; Milward, Joanna; Deluca, Paolo; Khadjesari, Zarnie; Watson, Rod; Fincham-Campbell, Stephanie; Drummond, Colin; Angus, Kathryn; Bauld, Linda; Baumann, Sophie; Haberecht, Katja; Schnuerer, Inga; Meyer, Christian; Rumpf, Hans-Jürgen; John, Ulrich; Gaertner, Beate; Barrault-Couchouron, Marion; Béracochéa, Marion; Allafort, Vincent; Barthélémy, Valérie; Bonnefoi, Hervé; Bussières, Emmanuel; Garguil, Véronique; Auriacombe, Marc; Saint-Jacques, Marianne; Dorval, Michel; M’Bailara, Katia; Segura-Garcia, Lidia; Ibañez-Martinez, Nuria; Mendive-Arbeloa, Juan Manuel; Anoro-Perminger, Manel; Diaz-Gallego, Pako; Piñar-Mateos, Mª Angeles; Colom-Farran, Joan; Deligianni, Marianthi; Yersin, Bertrand; Adam, Angeline; Weisner, Constance; Chi, Felicia; Lu, Wendy; Sterling, Stacy; Kraemer, Kevin L.; McGinnis, Kathleen A.; Fiellin, David A.; Skanderson, Melissa; Gordon, Adam J.; Robbins, Jonathan; Zickmund, Susan; Korthuis, P. Todd; Edelman, E. Jennifer; Hansen, Nathan B.; Cutter, Christopher J.; Dziura, James; Fiellin, Lynn E.; O’Connor, Patrick G.; Maisto, Stephen A.; Bedimo, Roger; Gilbert, Cynthia; Marconi, Vincent C.; Rimland, David; Rodriguez-Barradas, Maria; Simberkoff, Michael; Justice, Amy C.; Bryant, Kendall J.; Berman, Anne H; Shorter, Gillian W; Bray, Jeremy W; Barbosa, Carolina; Johansson, Magnus; Hester, Reid; Campbell, William; Souza Formigoni, Maria Lucia O.; Andrade, André Luzi Monezi; Sartes, Laisa Marcorela Andreoli; Sundström, Christopher; Eék, Niels; Kraepelien, Martin; Kaldo, Viktor; Fahlke, Claudia; Hernandez, Lynn; Becker, Sara J.; Jones, Richard N.; Graves, Hannah R.; Spirito, Anthony; Diestelkamp, Silke; Wartberg, Lutz; Arnaud, Nicolas; Thomasius, Rainer; Gaume, Jacques; Grazioli, Véronique; Fortini, Cristiana; Malan, Zelra; Mash, Bob; Everett-Murphy, Katherine; Grazioli, Véronique S.; Studer, Joseph; Mohler-Kuo, M.; Bertholet, Nicolas; Gmel, Gerhard; Doi, Lawrence; Cheyne, Helen; Jepson, Ruth; Luna, Vanesa; Echeverria, Leticia; Morales, Silvia; Barroso, Teresa; Abreu, Ângela; Aguiar, Cosma; Stewart, Duncan; Abreu, Angela; Brites, Riany M.; Jomar, Rafael; Marinho, Gerson; Parreira, Pedro; Seale, J. Paul; Johnson, J. Aaron; Henry, Dena; Chalmers, Sharon; Payne, Freida; Tuck, Linda; Morris, Akula; Gonçalves, Cátia; Besser, Bettina; Casajuana, Cristina; López-Pelayo, Hugo; Balcells, María Mercedes; Teixidó, Lídia; Miquel, Laia; Colom, Joan; Hepner, Kimberly A.; Hoggatt, Katherine. J.; Bogart, Andy; Paddock, Susan. M.; Hardoon, Sarah L; Petersen, Irene; Hamilton, Fiona L; Nazareth, Irwin; White, Ian R.; Marston, Louise; Wallace, Paul; Godfrey, Christine; Murray, Elizabeth; Sovinová, Hana; Csémy, Ladislav
PMCID:5032602
PMID: 27654147
ISSN: 1940-0640
CID: 5953382

Spontaneous viral clearance of hepatitis C virus (HCV) infection among people who inject drugs (PWID) and HIV-positive men who have sex with men (HIV+ MSM): a systematic review and meta-analysis

Smith, Daniel J; Jordan, Ashly E; Frank, Mayu; Hagan, Holly
BACKGROUND: Hepatitis C virus (HCV) infection causes significant morbidity and mortality among people who inject drugs (PWID) and HIV+ men who have sex with men (MSM). Characterizing spontaneous viral clearance of HCV infection among PWID and HIV+ MSM is important for assessing the burden of disease and treatment strategies in these populations. METHODS: Electronic and other searches of medical literature were conducted. Reports were eligible if they presented original data from upper-middle- and high-income countries on laboratory-confirmed HCV infection and spontaneous viral clearance among PWID or HIV+ MSM. Pooled estimates of spontaneous viral clearance were generated using fixed-effect and random-effects models. Meta-regression examined potential predictors related to individual characteristics and research methodology. RESULTS: The meta-analysis estimated that spontaneous viral clearance occurs in 24.4 % of PWID and 15.4 % of HIV+ MSM. In univariate meta-regression among PWID, male sex and age were significantly associated with spontaneous viral clearance, and in multivariate analysis, male sex and HIV positivity were predictors of spontaneous viral clearance; among HIV+ MSM no variables were found to affect spontaneous viral clearance. CONCLUSION: The variability in estimates of spontaneous viral clearance between HIV+ MSM and PWID suggests the impact of HIV co-infection and HCV re-infection. Due to limited data on additional factors that may affect the natural history of HCV, more research is needed to further understand spontaneous viral clearance in these risk groups. PROTOCOL REGISTRATION: The protocols for the PWID and HIV+ MSM research were registered with PROSPERO (CRD42014008805; CRD42013006462).
PMCID:5011802
PMID: 27595855
ISSN: 1471-2334
CID: 2238162

A qualitative study to understand guideline-discordant use of imaging to stage incident prostate cancer

Makarov, Danil V; Sedlander, Erica; Braithwaite, R Scott; Sherman, Scott E; Zeliadt, Steven; Gross, Cary P; Curnyn, Caitlin; Shedlin, Michele
BACKGROUND: Approximately half of veterans with low-risk prostate cancer receive guideline-discordant imaging. Our objective was to identify and describe (1) physician knowledge, attitudes, and practices related to the use of imaging to stage prostate cancer, (2) patient attitudes and behaviors related to use of imaging, and (3) to compare responses across three VA medical centers (VAMCs). METHODS: A qualitative approach was used to explore patient and provider knowledge and behaviors relating to the use of imaging. We conducted 39 semi-structured interviews total-including 22 interviews with patients with newly diagnosed with prostate cancer and 17 interviews with physicians caring for them-between September 2014 and July 2015 at three VAMCs representing a spectrum of inappropriate imaging rates. After core theoretical concepts were identified, the Theoretical Domains Framework (TDF) was selected to explore linkages between themes within the dataset and existing domains within the framework. Interviews were audio-recorded, transcribed verbatim, and then coded and analyzed using Nvivo software. RESULTS: Themes from patient interviews were categorized within four TDF domains. Patients reported little interest in staging as compared to disease treatment (goals), and many could not remember if they had imaging at all (knowledge). Patients tended to trust their doctor to make decisions about appropriate tests (beliefs about capabilities). Some patients expressed a minor concern for radiation exposure, but anxiety about cancer outcomes outweighed these fears (emotion). Themes from physician interviews were categorized within five TDF domains. Most physicians self-reported that they know and trust imaging guidelines (knowledge) yet some were still likely to follow their own intuition, whether due to clinical suspicion or years of experience (beliefs about capabilities). Additionally, physicians reported that medico-legal concerns, fear of missing associated diagnoses (beliefs about consequences), influence from colleagues who image frequently (social influences), and the facility where they practice influences rates of imaging (environmental context). CONCLUSIONS: Interviews with patients and physicians suggest that physicians are the primary (and in some cases only) decision-makers regarding staging imaging for prostate cancer. This finding suggests a physician-targeted intervention may be the most effective strategy to improve guideline-concordant prostate cancer imaging.
PMCID:5010696
PMID: 27590603
ISSN: 1748-5908
CID: 2232672