Strategies for Conducting Complex Clinical Trials in Diverse Community Practices

Orzano, A. John; Scott, Jewel; Hudson, Shawna V.; O’Malley, Dena; Hahn, Karissa A.; Haywood-Harris, Sonja; Falco, Terry; Johnson, Melanie; Crabtree, Benjamin F.

doi:10.1097/mlr.0b013e31814847a0

Cited by 7 publications

(8 citation statements)

References 13 publications

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“…Multiple clinical trials with 200 and 400 μg per day of inorganic selenium for months to years have shown no toxicity (51, 52). Another study reported no obvious toxicity with doses from 1600 to 3200 μg per day given for 12 months (53). We therefore expect that a dietary supplement of ~200 μg MSC /day, a level currently found in many multivitamin preparations, would be effective in resetting circadian rhythm in humans.…”

Section: Discussionmentioning

confidence: 99%

Methylselenocysteine Resets the Rhythmic Expression of Circadian and Growth-Regulatory Genes Disrupted by Nitrosomethylurea In vivo

Fang¹,

Zhang²,

Zarbl³

2010

Cancer Prevention Research

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Epidemiologic and animal studies indicate that disruption of circadian rhythm increases breast cancer risk. Previously, we showed that methylselenocysteine reduced the incidence of N-nitroso-N-methylurea (NMU)-induced mammary carcinomas in Fischer 344 rats by 63%. Methylselenocysteine also increased the expression of Period 2 (Per2) and D-binding protein (DBP), providing evidence for a link between circadian rhythm and chemoprevention. Here, we report that NMU disrupted the expression of core circadian genes (Per1, Per2, Cry1, Cry2, and RevErbAα) and circadian-controlled genes, including melatonin receptor 1α (MTNR1A), estrogen receptors (ERα and ERβ), and growth-regulatory genes (Trp53, p21, Gadd45α, and c-Myc) in mammary glands of Fischer 344 rats. By contrast, dietary methylselenocysteine (3 ppm selenium) given for 30 days, significantly enhanced the circadian expression of these genes (except for Cry1 and Cry2). The largest effect was on the levels of the Per2, MTNR1A, and ERβ mRNAs, which showed 16.5-fold, 4.7-fold, and 9.5-fold increases in their rhythm-adjusted means, respectively, and 44.5-fold, 6.5-fold, and 9.7-fold increases in amplitude as compared with the control diet, respectively. Methylselenocysteine also shifted the peak expression times of these genes to Zeitgeber time 12 (ZT12; lights off). Methylselenocysteine also induced rhythmic expression of Trp53, p21, and Gadd45α mRNAs with peak levels at ZT12, when c-Myc expression was at its lowest level. However, methylselenocysteine had no significant effect on the circadian expression of these genes in liver. These results suggest that dietary methylselenocysteine counteracted the disruptive effect of NMU on circadian expression of genes essential to normal mammary cell growth and differentiation. Cancer Prev Res; 3(5); 640-52. ©2010 AACR.

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Section: Discussionmentioning

confidence: 99%

Methylselenocysteine Resets the Rhythmic Expression of Circadian and Growth-Regulatory Genes Disrupted by Nitrosomethylurea In vivo

Fang¹,

Zhang²,

Zarbl³

2010

Cancer Prevention Research

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“…[31][32][33][34][35][36][37][38][39] Few studies have addressed potential benefits for the practice that extend beyond the study topic. As PBRN studies move from simply recording events to evaluating new management strategies and systems, the potential benefits to the practices increase.…”

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confidence: 99%

Practice Benefit from Participating in a Practice-based Research Network Study of Postpartum Depression: A National Research Network (NRN) Report

Yawn¹,

Pace²,

Dietrich³

et al. 2010

The Journal of the American Board of Family Medicine

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Background: At the midpoint of a large clinical trial taking place in a practice-based research network (PBRN), we asked leaders of the enrolled practices about the impact of participating in a PBRN study.Methods: Using semistructured interviews, the lead study nurse and physician from each site were queried about the impact of study participation on issues related to the study topic of postpartum depression (PPD) as well as any other impacts on the practice not directly related to PPD. From the results, initial themes were identified by 3 of the investigators (BPY, SB, MK) and confirmed by all the authors. Interviewee responses were grouped by theme.Results: Forty-eight study leaders from 28 solo, moderately sized group and residency practices were interviewed during a period of 60 days. Practices were located in 20 different states, and 54% were in rural communities. Six major themes emerged. Study participation led to: (1) the recognition of the need for systematic approaches; (2) more effective teamwork and communication within the practice; (3) adaptation and extension of the PPD study tools and a systematic approach to the care of other chronic conditions; (4) increased professional self-worth and community recognition; (5) opportunity and support for staff members to "stretch" into new roles; and (6)

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“…This cross-sectional analysis is based on the third-year data from control practices in the Using Learning Teams for Reflective Adaptation trial, a group randomized intervention study (Orzano et al, 2007a) aimed at testing a method for improving practice adherence to guidelines for multiple conditions. This trial was approved by the University of Medicine and Dentistry of New Jersey's institutional review board.…”

Section: Methodsmentioning

confidence: 99%

What can family medicine practices do to facilitate knowledge management?

Orzano

Ohman‐Strickland²,

Patel³

2008

Health Care Management Review

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Strategies for Conducting Complex Clinical Trials in Diverse Community Practices

Cited by 7 publications

References 13 publications

Methylselenocysteine Resets the Rhythmic Expression of Circadian and Growth-Regulatory Genes Disrupted by Nitrosomethylurea In vivo

Methylselenocysteine Resets the Rhythmic Expression of Circadian and Growth-Regulatory Genes Disrupted by Nitrosomethylurea In vivo

Practice Benefit from Participating in a Practice-based Research Network Study of Postpartum Depression: A National Research Network (NRN) Report

What can family medicine practices do to facilitate knowledge management?

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