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Matthew J Bair - One of the best experts on this subject based on the ideXlab platform.

  • the pragmatic explanatory continuum indicator summary precis instrument was useful for refining a randomized trial design experiences from an Investigative Team
    Journal of Clinical Epidemiology, 2010
    Co-Authors: Daniel L Riddle, Robert E Johnson, Mark P Jensen, Francis J Keefe, Kurt Kroenke, Matthew J Bair
    Abstract:

    Abstract Objective A recently published instrument (PRECIS) was designed to assist Investigative Teams in understanding the various design decisions that need to be made regarding pragmatic vs. explanatory trials. Our Team used this instrument during an investigators' meeting to organize our discussion regarding the design of a planned trial and to determine the extent of consensus among the study investigators. Study Design and Setting The study was descriptive in nature and occurred during an investigator meeting. After reading and reviewing the 10 PRECIS criteria, the Team made quantitative judgments of the planned study regarding each PRECIS criteria to reflect initial, ideal, and final study design perceptions. Results Data indicated that the final study design was more explanatory in nature than the preliminary plan. Evidence of consensus was obtained. Conclusion The Investigative Team found that applying PRECIS principles were useful for (1) detailing points of discussion related to trial design, (2) making revisions to the design to be consistent with the project goals, and (3) achieving consensus. We believe our experiences with PRECIS may prove valuable for trial researchers in much the same way that case reports can provide valuable insights for clinicians.

  • the precis instrument was useful for refining a randomized trial design experiences from an Investigative Team
    Journal of Clinical Epidemiology, 2010
    Co-Authors: Daniel L Riddle, Robert E Johnson, Mark P Jensen, Francis J Keefe, Kurt Kroenke, Matthew J Bair
    Abstract:

    Objective A recently published instrument (PRECIS) was designed to assist Investigative Teams in understanding the various design decisions that need to be made regarding pragmatic versus explanatory trials. Our Team used this instrument during an investigators’ meeting to organize our discussion regarding the design of a planned trial and to determine the extent of consensus among the study investigators.

Michael Lefevre - One of the best experts on this subject based on the ideXlab platform.

  • funding food science and nutrition research financial conflicts and scientific integrity
    The American Journal of Clinical Nutrition, 2009
    Co-Authors: Sylvia Rowe, Nick Alexander, F M Clydesdale, Rhona S Applebaum, Stephanie Atkinson, Richard Black, Johanna T Dwyer, Eric Hentges, Nancy A Higley, Michael Lefevre
    Abstract:

    There has been significant public debate about the susceptibility of research to biases of various kinds. The dialogue has extended to the peer-reviewed literature, scientific conferences, the mass media, government advisory bodies, and beyond. Whereas biases can come from myriad sources, the overwhelming focus of the discussion to date has been on industry-funded science. Given the critical role that industry has played and will continue to play in the research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this article, proposed conflict-of-interest guidelines regarding industry funding to protect the integrity and credibility of the scientific record, particularly with respect to health, nutrition, and food-safety science. Eight principles are enumerated, which specify the ground rules for industry-sponsored research. This article, which issues a challenge to the broader scientific community to address all bias issues, is only a first step; the document is intended to be dynamic, prompting ongoing discussion and refinement. In the conduct of public/private research relationships, all relevant parties shall 1) conduct or sponsor research that is factual, transparent, and designed objectively, and, according to accepted principles of scientific inquiry, the research design will generate an appropriately phrased hypothesis and the research will answer the appropriate questions, rather than favor a particular outcome; 2) require control of both study design and research itself to remain with scientific investigators; 3) not offer or accept remuneration geared to the outcome of a research project; 4) ensure, before the commencement of studies, that there is a written agreement that the Investigative Team has the freedom and obligation to attempt to publish the findings within some specified time frame; 5) require, in publications and conference presentations, full signed disclosure of all financial interests; 6) not participate in undisclosed paid authorship arrangements in industry-sponsored publications or presentations; 7) guarantee accessibility to all data and control of statistical analysis by investigators and appropriate auditors/reviewers; 8) require that academic researchers, when they work in contract research organizations (CRO) or act as contract researchers, make clear statements of their affiliation; and require that such researchers publish only under the auspices of the CRO.

  • funding food science and nutrition research financial conflicts and scientific integrity
    Nutrition Reviews, 2009
    Co-Authors: Sylvia Rowe, Nick Alexander, F M Clydesdale, Rhona S Applebaum, Stephanie Atkinson, Richard Black, Johanna T Dwyer, Eric Hentges, Nancy A Higley, Michael Lefevre
    Abstract:

    There has been significant public debate about the susceptibility of research to biases of various kinds. The dialogue has extended to the peer-reviewed literature, scientific conferences, the mass media, government advisory bodies, and beyond. While biases can come from myriad sources, the overwhelming focus of the discussion, to date, has been on industry-funded science. Given the critical role that industry has played and will continue to play in the research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this paper, set out proposed conflict-of-interest guidelines, regarding industry funding, for protecting the integrity and credibility of the scientific record, particularly with respect to health, nutrition, and food-safety science. Eight principles are enumerated, specifying ground rules for industry-sponsored research. The paper, which issues a challenge to the broader scientific community to address all bias issues, is only a first step; the document is intended to be dynamic, prompting ongoing discussion and refinement. The Guiding Principles are as follows. In the conduct of public/private research relationships, all relevant parties shall: 1) conduct or sponsor research that is factual, transparent, and designed objectively; according to accepted principles of scientific inquiry, the research design will generate an appropriately phrased hypothesis and the research will answer the appropriate questions, rather than favor a particular outcome; 2) require control of both study design and research itself to remain with scientific investigators; 3) not offer or accept remuneration geared to the outcome of a research project; 4) prior to the commencement of studies, ensure that there is a written agreement that the Investigative Team has the freedom and obligation to attempt to publish the findings within some specified time-frame; 5) require, in publications and conference presentations, full signed disclosure of all financial interests; 6) not participate in undisclosed paid authorship arrangements in industry-sponsored publications or presentations; 7) guarantee accessibility to all data and control of statistical analysis by investigators and appropriate auditors/reviewers; and 8) require that academic researchers, when they work in contract research organizations (CRO) or act as contract researchers, make clear statements of their affiliation; require that such researchers publish only under the auspices of the CRO.

Daniel L Riddle - One of the best experts on this subject based on the ideXlab platform.

  • the pragmatic explanatory continuum indicator summary precis instrument was useful for refining a randomized trial design experiences from an Investigative Team
    Journal of Clinical Epidemiology, 2010
    Co-Authors: Daniel L Riddle, Robert E Johnson, Mark P Jensen, Francis J Keefe, Kurt Kroenke, Matthew J Bair
    Abstract:

    Abstract Objective A recently published instrument (PRECIS) was designed to assist Investigative Teams in understanding the various design decisions that need to be made regarding pragmatic vs. explanatory trials. Our Team used this instrument during an investigators' meeting to organize our discussion regarding the design of a planned trial and to determine the extent of consensus among the study investigators. Study Design and Setting The study was descriptive in nature and occurred during an investigator meeting. After reading and reviewing the 10 PRECIS criteria, the Team made quantitative judgments of the planned study regarding each PRECIS criteria to reflect initial, ideal, and final study design perceptions. Results Data indicated that the final study design was more explanatory in nature than the preliminary plan. Evidence of consensus was obtained. Conclusion The Investigative Team found that applying PRECIS principles were useful for (1) detailing points of discussion related to trial design, (2) making revisions to the design to be consistent with the project goals, and (3) achieving consensus. We believe our experiences with PRECIS may prove valuable for trial researchers in much the same way that case reports can provide valuable insights for clinicians.

  • the precis instrument was useful for refining a randomized trial design experiences from an Investigative Team
    Journal of Clinical Epidemiology, 2010
    Co-Authors: Daniel L Riddle, Robert E Johnson, Mark P Jensen, Francis J Keefe, Kurt Kroenke, Matthew J Bair
    Abstract:

    Objective A recently published instrument (PRECIS) was designed to assist Investigative Teams in understanding the various design decisions that need to be made regarding pragmatic versus explanatory trials. Our Team used this instrument during an investigators’ meeting to organize our discussion regarding the design of a planned trial and to determine the extent of consensus among the study investigators.

Sylvia Rowe - One of the best experts on this subject based on the ideXlab platform.

  • funding food science and nutrition research financial conflicts and scientific integrity
    The American Journal of Clinical Nutrition, 2009
    Co-Authors: Sylvia Rowe, Nick Alexander, F M Clydesdale, Rhona S Applebaum, Stephanie Atkinson, Richard Black, Johanna T Dwyer, Eric Hentges, Nancy A Higley, Michael Lefevre
    Abstract:

    There has been significant public debate about the susceptibility of research to biases of various kinds. The dialogue has extended to the peer-reviewed literature, scientific conferences, the mass media, government advisory bodies, and beyond. Whereas biases can come from myriad sources, the overwhelming focus of the discussion to date has been on industry-funded science. Given the critical role that industry has played and will continue to play in the research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this article, proposed conflict-of-interest guidelines regarding industry funding to protect the integrity and credibility of the scientific record, particularly with respect to health, nutrition, and food-safety science. Eight principles are enumerated, which specify the ground rules for industry-sponsored research. This article, which issues a challenge to the broader scientific community to address all bias issues, is only a first step; the document is intended to be dynamic, prompting ongoing discussion and refinement. In the conduct of public/private research relationships, all relevant parties shall 1) conduct or sponsor research that is factual, transparent, and designed objectively, and, according to accepted principles of scientific inquiry, the research design will generate an appropriately phrased hypothesis and the research will answer the appropriate questions, rather than favor a particular outcome; 2) require control of both study design and research itself to remain with scientific investigators; 3) not offer or accept remuneration geared to the outcome of a research project; 4) ensure, before the commencement of studies, that there is a written agreement that the Investigative Team has the freedom and obligation to attempt to publish the findings within some specified time frame; 5) require, in publications and conference presentations, full signed disclosure of all financial interests; 6) not participate in undisclosed paid authorship arrangements in industry-sponsored publications or presentations; 7) guarantee accessibility to all data and control of statistical analysis by investigators and appropriate auditors/reviewers; 8) require that academic researchers, when they work in contract research organizations (CRO) or act as contract researchers, make clear statements of their affiliation; and require that such researchers publish only under the auspices of the CRO.

  • funding food science and nutrition research financial conflicts and scientific integrity
    Nutrition Reviews, 2009
    Co-Authors: Sylvia Rowe, Nick Alexander, F M Clydesdale, Rhona S Applebaum, Stephanie Atkinson, Richard Black, Johanna T Dwyer, Eric Hentges, Nancy A Higley, Michael Lefevre
    Abstract:

    There has been significant public debate about the susceptibility of research to biases of various kinds. The dialogue has extended to the peer-reviewed literature, scientific conferences, the mass media, government advisory bodies, and beyond. While biases can come from myriad sources, the overwhelming focus of the discussion, to date, has been on industry-funded science. Given the critical role that industry has played and will continue to play in the research process, the International Life Sciences Institute (ILSI) North America Working Group on Guiding Principles has, in this paper, set out proposed conflict-of-interest guidelines, regarding industry funding, for protecting the integrity and credibility of the scientific record, particularly with respect to health, nutrition, and food-safety science. Eight principles are enumerated, specifying ground rules for industry-sponsored research. The paper, which issues a challenge to the broader scientific community to address all bias issues, is only a first step; the document is intended to be dynamic, prompting ongoing discussion and refinement. The Guiding Principles are as follows. In the conduct of public/private research relationships, all relevant parties shall: 1) conduct or sponsor research that is factual, transparent, and designed objectively; according to accepted principles of scientific inquiry, the research design will generate an appropriately phrased hypothesis and the research will answer the appropriate questions, rather than favor a particular outcome; 2) require control of both study design and research itself to remain with scientific investigators; 3) not offer or accept remuneration geared to the outcome of a research project; 4) prior to the commencement of studies, ensure that there is a written agreement that the Investigative Team has the freedom and obligation to attempt to publish the findings within some specified time-frame; 5) require, in publications and conference presentations, full signed disclosure of all financial interests; 6) not participate in undisclosed paid authorship arrangements in industry-sponsored publications or presentations; 7) guarantee accessibility to all data and control of statistical analysis by investigators and appropriate auditors/reviewers; and 8) require that academic researchers, when they work in contract research organizations (CRO) or act as contract researchers, make clear statements of their affiliation; require that such researchers publish only under the auspices of the CRO.

Paul K Whelton - One of the best experts on this subject based on the ideXlab platform.

  • the egyptian national hypertension project nhp design and rationale the nhp Investigative Team
    Hypertension, 1995
    Co-Authors: Zeinab Ashour, Mohsen M Ibrahim, Lawrence J Appel, Amal Sami Ibrahim, Paul K Whelton
    Abstract:

    : Hypertension and its complications appear to be increasingly common in Egypt. The National Hypertension Project (NHP) is a collaborative Egyptian-American effort with the following objectives: (1) to determine the prevalence of hypertension and blood pressure-related preclinical and clinical complications in Egyptian adults, (2) to identify environmental factors associated with high blood pressure, and (3) to build an infrastructure for research and education in cardiovascular disease prevention in Egypt. The NHP surveys were conducted in six of Egypt's 26 governorates, representing distinct geographic regions. In each of these six governorates, a probability sample of 600 households was surveyed. NHP was conducted in two phases. In phase I a Team of specially trained physicians conducted household surveys in which all adult residents (age > or = 25 years) were screened for hypertension. In phase II hypertensive adults identified in phase I (ie, those with systolic pressure > or = 140 mm Hg and/or diastolic pressure > or = 90 mm Hg and/or those receiving antihypertensive drug therapy) along with a randomly selected sample of normotensive control subjects were asked to participate in a more extensive evaluation. This included a detailed history and clinical examination, an electrocardiogram, an echocardiogram, laboratory studies, and skin color reflectance (on a subsample). As the first systematic, national survey of hypertension and its complications in an Arab country, NHP should provide data of great interest to the scientific, provider, and public health communities.

  • hypertension prevalence awareness treatment and control in egypt results from the egyptian national hypertension project nhp nhp Investigative Team
    Hypertension, 1995
    Co-Authors: Mohsen M Ibrahim, Zeinab Ashour, Lawrence J Appel, Hussein Rizk, El Aroussy W, Sherif Helmy, Yasser Sharaf, Hossam Kandil, Edward J Roccella, Paul K Whelton
    Abstract:

    : This report from the Egyptian National Hypertension Project presents national estimates of the prevalence of hypertension and the extent to which high blood pressure is being detected, treated with medications, and controlled in the Egyptian population. The results are based on findings from a national probability survey of adults > or = 25 years of age conducted in six Egyptian governorates. With the use of a stratified multistage probability design, 6733 people (85% response rate) were examined. Hypertension was defined as systolic pressure > or = 140 mm Hg, and/or diastolic pressure > or = 90 mm Hg, and/or reported treatment with one or more antihypertensive medications. Overall, the estimated prevalence of hypertension in Egypt was 26.3%. Hypertension prevalence increased progressively with age, from 7.8% in 25- to 34-year-olds to 56.6% in those 75 years or older. Hypertension was slightly more common in women than in men (26.9% versus 25.7%, respectively). Overall, 37.5% of hypertensive individuals were aware that they had high blood pressure, 23.9% were being treated with antihypertensive medications, and 8.0% were under control (systolic pressure < 140 mm Hg and diastolic pressure < 90 mm Hg). Hypertension prevalence as well as awareness, treatment, and control rates varied by region, with Cairo having the highest prevalence (31.0%) and the Coastal Region having the highest control rate (15.9%). Rates of awareness, treatment, and control tended to be lowest in areas of lower socioeconomic status. Our results indicate that hypertension is highly prevalent in Egypt and that the rates of hypertension is awareness, treatment, and control are relatively low.(ABSTRACT TRUNCATED AT 250 WORDS)