Carol M Ashton

Houston Methodist Hospital, Houston, Texas, United States

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Publications (102)540.97 Total impact

  • Article: Reply.
    Baruch Brody, Nelda Wray, Carol Ashton
    Journal of the American College of Surgeons 07/2013; 217(1):172. · 4.45 Impact Factor
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    ABSTRACT: As national quality initiatives are increasing requirements for individual physician data, our department of surgery initiated a surgeon-specific reporting (SSR) program to assess the value of personal knowledge on individual performance quality. We sought to evaluate the use of SSR as a tool to enable surgeons to assess and improve their clinical performance, and to identify barriers to use of their reports. Qualitative research design involving semistructured interviews of surgeons who received performance reports derived from National Surgical Quality Improvement Program (NSQIP), Surgical Care Improvement Project (SCIP), and the Centers for Medicare and Medicaid Services (CMS) core measures and hospital administrative data. Transcripts were analyzed by the constant comparative method. Twenty-four of 39 surgeons (61.5%) who received their SSRs agreed to be interviewed and 23 were interviewed. About half (11 of 23) demonstrated comprehension of the data validity, accuracy, or complexity. Of these, 6 took steps to validate data or improve performance. Most respondents believed SSR would lead to performance improvement through knowledge of personal outcomes and peer comparison; however, they perceived SSR had limitations, such as small sample size and potential coding errors, and could lead to unintended consequences, such as inaccurate interpretation by others and surgeons' aversion to selecting high-risk patients. Respondents also suggested logistical improvements to reporting methods, such as report format and definitions of metrics. Surgeon-specific reporting has the potential to empower surgeons to improve their practice; however, more surgeons need efficient guidelines to understand the metrics. Our findings can be used to guide development of more SSR programs. Whether SSR programs lead to improvements in surgical outcomes is a matter for future research.
    Journal of the American College of Surgeons 06/2013; · 4.45 Impact Factor
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    ABSTRACT: BACKGROUND: Many published accounts of clinical trials report no differences between the treatment arms, while being underpowered to find differences. This study determined how the authors of these reports interpreted their findings. STUDY DESIGN: We examined 54 reports of surgical trials chosen randomly from a database of 110 influential trials conducted in 2008. Seven that reported having adequate statistical power (β ≥ 0.9) were excluded from further analysis, as were the 32 that reported significant differences between the treatment arms. We examined the remaining 15 to see whether the authors interpreted their negative findings appropriately. Appropriate interpretations discussed the lack of power and/or called for larger studies. RESULTS: Three of the 7 trials that did not report an a priori power calculation offered inappropriate interpretations, as did 3 of the 8 trials that reported an a priori power < 0.90. However, we examined only a modest number of trial reports from 1 year. CONCLUSIONS: Negative findings in underpowered trials were often interpreted as showing the equivalence of the treatment arms with no discussion of the issue of being underpowered. This may lead clinicians to accept new treatments that have not been validated.
    Journal of the American College of Surgeons 11/2012; · 4.45 Impact Factor
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    ABSTRACT: Regulatory and professional bodies issue an ever-increasing number of guidance documents on the ethics and methods of clinical trials, but the quality of clinical trials of invasive therapeutic procedures continues to be a concern. We interviewed aspiring and accomplished surgical trialists to understand how they use guidance documents and other resources in their work. We performed a qualitative research study involving semistructured interviews of a diverse sample of 15 surgical trialists. Professional development as a surgical trialist was haphazard, inefficient, and marked by avoidable mistakes. Four types of resources played constructive roles: formal education; written materials on clinical trials; experience with actual trials; and interpersonal interactions with peers, experts, collaborators, and mentors. Recommendations for improvement centered on education, mentoring, networking, participating in trials, and facilitation by department chairs. The haphazard and unstructured nature of the current system is adding unnecessarily to the numerous challenges faced by surgical trialists.
    American journal of surgery 09/2012; 204(3):339-346.e5. · 2.36 Impact Factor
  • Journal of the American College of Surgeons 07/2012; 215(5):722-30. · 4.45 Impact Factor
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    ABSTRACT: Utilizing a sorted compendium of international clinical trial standards, investigators identified 15 conflicts among ethical and methodological guidance. Analysis distinguishes interpretational issues, lack of clarity, and contradiction as factors to be addressed if international trial guidance is to be improved.
    The Journal of Law Medicine &amp Ethics 03/2012; 40(1):99-121. · 0.94 Impact Factor
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    ABSTRACT: There is little evidence on comparative effectiveness of individual angiotensin receptor blockers (ARBs) in patients with chronic heart failure (CHF). This study compared four ARBs in reducing risk of mortality in clinical practice. A retrospective analysis was conducted on a national sample of patients diagnosed with CHF from 1 October 1996 to 30 September 2002 identified from Veterans Affairs electronic medical records, with supplemental clinical data obtained from chart review. After excluding patients with exposure to ARBs within the previous 6 months, four treatment groups were defined based on initial use of candesartan, valsartan, losartan, and irbesartan between the index date (1 October 2000) and the study end date (30 September 2002). Time to death was measured concurrently during that period. A marginal structural model controlled for sociodemographic factors, comorbidities, comedications, disease severity (left ventricular ejection fraction), and potential time-varying confounding affected by previous treatment (hospitalization). Propensity scores derived from a multinomial logistic regression were used as inverse probability of treatment weights in a generalized estimating equation to estimate causal effects. Among the 1536 patients identified on ARB therapy, irbesartan was most frequently used (55.21%), followed by losartan (21.74%), candesartan (15.23%), and valsartan (7.81%). When compared with losartan, after adjusting for time-varying hospitalization in marginal structural model, candesartan (OR = 0.79, 95%CI = 0.42-1.50), irbesartan (OR = 1.17, 95%CI = 0.72-1.90), and valsartan (OR =  0.98, 95%CI = 0.45-2.14) were found to have similar effectiveness in reducing mortality in CHF patients. Effectiveness of ARBs in reducing mortality is similar in patients with CHF in everyday clinical practice.
    Pharmacoepidemiology and Drug Safety 07/2011; 21(3):233-40. · 2.90 Impact Factor
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    ABSTRACT: If trials of therapeutic interventions are to serve society's interests, they must be of high methodological quality and must satisfy moral commitments to human subjects. The authors set out to develop a clinical-trials compendium in which standards for the ethical treatment of human subjects are integrated with standards for research methods. The authors rank-ordered the world's nations and chose the 31 with >700 active trials as of 24 July 2008. Governmental and other authoritative entities of the 31 countries were searched, and 1004 English-language documents containing ethical and/or methodological standards for clinical trials were identified. The authors extracted standards from 144 of those: 50 designated as 'core', 39 addressing trials of invasive procedures and a 5% sample (N=55) of the remainder. As the integrating framework for the standards we developed a coherent taxonomy encompassing all elements of a trial's stages. Review of the 144 documents yielded nearly 15 000 discrete standards. After duplicates were removed, 5903 substantive standards remained, distributed in the taxonomy as follows: initiation, 1401 standards, 8 divisions; design, 1869 standards, 16 divisions; conduct, 1473 standards, 8 divisions; analysing and reporting results, 997 standards, four divisions; and post-trial standards, 168 standards, 5 divisions. The overwhelming number of source documents and standards uncovered in this study was not anticipated beforehand and confirms the extraordinary complexity of the clinical trials enterprise. This taxonomy of multinational ethical and methodological standards may help trialists and overseers improve the quality of clinical trials, particularly given the globalisation of clinical research.
    Journal of medical ethics 03/2011; 37(6):368-73. · 1.69 Impact Factor
  • Carol M Ashton, Cheryl L Holt, Nelda P Wray
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    ABSTRACT: To develop a preliminary version of a post-doctor visit self-assessment tool that patients with hypertension can use to evaluate their communication behaviors. High-quality communication between patient and doctor may have a positive effect on blood pressure control in hypertensive patients. Patients' communicative behaviors such as asking questions influence those of doctors, but most existing measurement tools assess doctors' behaviors rather than patients'. The tool is intended for use by African American or Caucasian American adults with hypertension, regardless of literacy level. The project included theory-based development of the item pool, usability testing (8 individuals), and cognitive response testing (13 additional individuals). After multiple iterations, the preliminary version includes 138 items in 7 theory-based domains. The self-assessment tool is ready for testing of item and scale reliability and validity and consequent item reduction. This tool could prove useful in trials evaluating whether patients with hypertension who learn to be better communicators are more likely to achieve blood pressure control. In addition, because it asks patients to reflect on their use of specific behaviors that can be learned, the tool might also help patients in clinical practice to assume more active roles during their medical interactions.
    Patient Education and Counseling 04/2010; 81(2):275-314. · 2.60 Impact Factor
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    ABSTRACT: This paper focuses on invasive therapeutic procedures, defined as procedures requiring the introduction of hands, instruments, or devices into the body via incisions or punctures of the skin or mucous membranes performed with the intent of changing the natural history of a human disease or condition for the better. Ethical and methodological concerns have been expressed about studies designed to evaluate the effects of invasive therapeutic procedures. Can such studies meet the same standards demanded of those, for example, evaluating pharmaceutical agents? This paper describes a research project aimed at examining the interplay and sometimes apparent conflict between ethical standards for human research and standards for methodological rigor in trials of invasive procedures. The paper discusses how the authors plan to develop a set of consensus standards that, if met, would result in substantial and much-needed improvements in the methodological and ethical quality of such trials.
    Journal of medical ethics 10/2009; 35(9):579-83. · 1.69 Impact Factor
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    ABSTRACT: Our goal was to develop an interactive DVD to help African American and Caucasian American adults with hypertension learn how to become better communicators during medical interactions. Material was to be presented in several formats, including patients' narratives (stories). To develop the narratives we recruited members of the target audience and elicited stories and story units in focus groups, interviews, and seminars. Story units were ranked-ordered based on conformance with the theory of planned behavior and narrative qualities and then melded into cohesive stories. The stories were recounted by actors on the DVD. 55 adults (84% women; 93% African American) participated in a focus group, interview, or seminar; transcripts yielded 120 story units. The most highly rated units were woven into 11 stories. The six highest rated stories/actor-storytellers were selected for presentation on the DVD. We achieved our goal of developing an easy-to-use, story-driven product that may teach adults how to talk effectively with their doctors about hypertension. The DVD's effectiveness should be tested in a randomized trial. Behavioral interventions aimed at improving patients' ability to communicate during doctor visits may be useful adjuncts in the achievement of BP goals.
    Patient Education and Counseling 10/2009; 79(2):245-50. · 2.60 Impact Factor
  • Value in Health 10/2009; 12(7). · 2.89 Impact Factor
  • Value in Health 05/2009; 12(3). · 2.89 Impact Factor
  • Value in Health 05/2008; 11(3). · 2.89 Impact Factor
  • Value in Health 05/2008; 11(3). · 2.89 Impact Factor
  • Value in Health 05/2008; 11(3). · 2.89 Impact Factor
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    ABSTRACT: Links between clinical and public health interventions are limited. Using the Internet as a delivery method provides the potential to link multiple intervention components, but this potential has not yet been realized. In this poster, we present results of a formative assessment to identify approaches to improving clinical-public health linkages.
    AMIA ... Annual Symposium proceedings / AMIA Symposium. AMIA Symposium 02/2008;
  • Source
    Stephen P. Glasser, Carol M. Ashton, Nelda P. Wray
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    ABSTRACT: The USFDA is an agency of the US Department of Health and Human Services and is the nation’s oldest consumer protection agency whose function it is to review drugs before marketing, monitor marketed drugs, monitor drug manufacturing and advertising, protect drug quality, and to conduct applied research. It is charged with overseeing of not only human drugs and biologics, but also veterinary drugs, foods, medical devices, and radiopharmaceuticals, and as such serves as a watch dog over industry. This chapter discusses the historical development of the FDA, and what the FDA is today. The phases of research development leading to the marketing of a new drug, the role of the FDA in surgical interventions, and the FDA’s role in advertising and adverse event reporting are discussed.
    12/2007: pages 93-110;
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    ABSTRACT: The authors randomized 101 male veterans with chronic combat-related posttraumatic stress disorder (PTSD) and depressive disorder to an evidence-based depression treatment (self-management therapy; n = 51) or active-control therapy (n = 50). Main outcome measures for efficacy, using intention-to-treat analyses, were subjective and objective PTSD and depression scales at pretest, posttest, and 3-, 6-, and 12-month follow-up. Other measures included treatment compliance, satisfaction, treatment-targeted constructs, functioning, service utilization, and costs. Self-management therapy's modestly greater improvement on depression symptoms at treatment completion disappeared on follow-up. No other differences on symptoms or functioning appeared, although psychiatric outpatient utilization and overall outpatient costs were lower with self-management therapy. Despite success in other depressed populations, self-management therapy produced no clinically significant effect in depression with chronic PTSD.
    Journal of Traumatic Stress 07/2007; 20(3):221-37. · 2.72 Impact Factor
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    ABSTRACT: We investigated the association of process of care measures with adverse limb and systemic events in patients with peripheral arterial disease (PAD). We conducted a retrospective cohort study of patients with PAD, as defined by an ankle-brachial index (ABI) <0.9. The index date was defined as the date, during 1995 to 1998, when the patient was seen in the Michael E. DeBakey VA Medical Center noninvasive vascular laboratory and found to have PAD. We conducted a chart review for process of care variables starting 3 years before the index date and ending at the time of the first event or the final visit (December 31, 2001), whichever occurred first. We examined the association between PAD process of care measures, including risk factor control, and prescribing of medication, with time of the patient's first major limb event or death. Of the 796 patients (mean age, 65 +/- 9.9 years), 230 (28.9% experienced an adverse limb event (136 lower-extremity bypass, 94 lower-extremity amputation), and 354 (44.5%) died. Of the patients who died, 247 died without a preceding limb event. Glucose control was protective against death or a limb event with a hazard ratio (HR) of 0.74 (95% confidence limits [CL] 0.60, 0.91, P = 0.004). African Americans were at 2.8 (95% CL 1.7, 4.5) times the risk of Whites or Hispanics for an adverse limb event. However, this risk was no longer significant if their glucose was controlled. For process measures, the dispensing of PAD specific medication (HR 1.4, 95% CL 1.1, 1.7) was associated an increased risk for an adverse outcome. Our data suggest that glucose control is key to reducing the risk for adverse outcomes, particularly limb events in African Americans. Certain process of care measures, as markers of disease severity and disease management, are associated with poor outcomes in patients with PAD. Further work is needed to determine the role of early disease intervention to reduce poor outcomes in patients with PAD.
    Journal of General Internal Medicine 07/2007; 22(7):942-8. · 3.42 Impact Factor

Publication Stats

3k Citations
540.97 Total Impact Points


  • 2009–2013
    • Houston Methodist Hospital
      Houston, Texas, United States
  • 2012
    • Rice University
      • Department of Philosophy
      Houston, Texas, United States
    • Weill Cornell Medical College
      New York, New York, United States
  • 2011
    • Methodist Hospitals
      Gary, Indiana, United States
  • 1989–2009
    • Baylor College of Medicine
      • • Department of Medicine
      • • Veterans Affairs Medical Center
      • • Section of General Internal Medicine
      Houston, Texas, United States
  • 2007–2008
    • University of Alabama at Birmingham
      • Center for Outcomes and Effectiveness Research and Education
      Birmingham, AL, United States
  • 1991–2007
    • Minneapolis Veterans Affairs Hospital
      Minneapolis, Minnesota, United States
  • 2005–2006
    • Michael E. DeBakey VA Medical Center
      Houston, Texas, United States
  • 1988–2003
    • San Francisco VA Medical Center
      San Francisco, California, United States
  • 2001
    • Rogers Memorial Hospital
      Oconomowoc, Wisconsin, United States
  • 1999
    • Spokane VA Medical Center
      Spokane, Washington, United States
    • Indiana University-Purdue University School of Medicine
      Indianapolis, Indiana, United States
  • 1998
    • U.S. Department of Veterans Affairs
      Washington, Washington, D.C., United States