Daniel B. Stryer

Bio: Daniel B. Stryer is an academic researcher from Indian Health Service. The author has contributed to research in topics: Health care & Patient safety. The author has an hindex of 5, co-authored 11 publications receiving 1859 citations.

Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy.

Abstract: Decision makers in health care are increasingly interested in using highquality scientific evidence to support clinical and health policy choices; however, the quality of available scientific evidence is often found to be inadequate. Reliable evidence is essential to improve health care quality and to support efficient use of limited resources. The widespread gaps in evidencebased knowledge suggest that systematic flaws exist in the production of scientific evidence, in part because there is no consistent effort to conduct clinical trials designed to meet the needs of decision makers. Clinical trials for which the hypothesis and study design are developed specifically to answer the questions faced by decision makers are called pragmatic or practical clinical trials (PCTs). The characteristic features of PCTs are that they (1) select clinically relevant alternative interventions to compare, (2) include a diverse population of study participants, (3) recruit participants from heterogeneous practice settings, and (4) collect data on a broad range of health outcomes. The supply of PCTs is limited primarily because the major funders of clinical research, the National Institutes of Health and the medical products industry, do not focus on supporting such trials. Increasing the supply of PCTs will depend on the development of a mechanism to establish priorities for these studies, significant expansion of an infrastructure to conduct clinical research within the health care delivery system, more reliance on high-quality evidence by health care decision makers, and a substantial increase in public and private funding for these studies. For these changes to occur, clinical and health policy decision makers will need to become more involved in all aspects of clinical research, including priority setting, infrastructure development, and funding.

The national healthcare quality and disparities reports: an overview.

Abstract: Background Congress directed the Agency for Healthcare Research and Quality (AHRQ) to lead an effort for the US Department of Health and Human Services (DHHS) to develop 2 annual reports: a National Healthcare Quality Report (NHQR) and a National Healthcare Disparities Report (NHDR). Objectives This article lays out key concepts, definitions, statistical methods, and findings from these first ever national reports on quality and disparities. We also summarize some possible future directions for the reports. Research design The NHQR and NHDR rely on secondary analysis of available data from over 40 established, national databases. The NHQR presents data at the national level, by sociodemographic characteristics, and at the state level. The NHDR presents data broken out by race/ethnicity and by socioeconomic status. Measures The 2003 NHQR presented data on approximately 140 quality measures and the NHDR presented data on these same measures plus approximately 100 measures of access to care. Results The reports found that high healthcare quality is not a given and that disparities are pervasive throughout the US healthcare system. In addition, they found the quality and disparities issues are particularly apparent in preventive care, but that greater improvement is possible. Conclusions As these reports evolve for the 2004 version and beyond, they will be a vital step in the effort to improve healthcare quality for all populations in the United States.

Characteristics of materials distributed by drug companies. An evaluation of appropriateness.

Abstract: OBJECTIVES: To describe material distributed to physicians by pharmaceutical companies; to describe characteristics of the drugs discussed in the material; to determine whether the material complies with Food and Drug Administration (FDA) regulations and whether it contains promotional and educational characteristics.

Patients' safety: Progress is elusive because culture in health care has not changed

Abstract: Since 2000, when “To Err Is Human” stimulated action to eliminate errors and mitigate the resultant harm in the United States1 and “An Organisation with a Memory” initiated similar efforts in the United Kingdom,2 healthcare systems worldwide have devoted considerable attention to the safety of patients. Yet despite attempts to reduce adverse events through multilevel interventions and information technology, widespread change in the culture of health care remains elusive. The numbers of affected patients are astounding. In the United Kingdom, adverse events with resultant harm were estimated to occur in some 10% of hospital admissions, equating to more than 850 000 events annually. In the United States, extrapolations based on medical record reviews imply that 44 000-98 000 lives were lost because of medical errors each year. Although some posit that these numbers were inflated, ongoing work indicates that these estimates may be conservative. For example, Davis et al found that 12.9% of hospital admissions in New Zealand were associated with an adverse event.3 Zhan and Miller examined the incidence of 18 hospital based diagnoses suggestive of errors and found that injuries may add 2.4 million extra days in hospital and more than 32 000 deaths per year in the United States.4 Numerous systems for error identification have been developed, the most promising of which combines analysis of automated data, medical record review, and active event reporting.5 The Australian Patient Safety Foundation and the United Kingdom's National Patient Safety Agency have implemented systems for event surveillance. In the United States, legislation is pending that would facilitate sharing reports and analysing errors without fear of increased litigation. This legislation would complement the actions taken by states. Currently, 21 states have mandatory reporting systems; but under-reporting remains a serious challenge.6 Although implementation of reporting systems will shed additional light on threats to safety, unresolved dilemmas remain regarding the appropriate balance between breadth and depth of reports, confidentiality, and the public's right to know, and whether to focus on actionable processes (that is, medical errors) or harms irrespective of antecedents.7 The overarching challenge, ripe for transnational collaboration, is identifying the most effective strategies for translating information on errors and near misses into safety for patients. Numerous resources can help organisations in implementing evidence based safety interventions. The United States Agency for Healthcare Research and Quality produced an evidence report that reviewed 79 patient safety practices, as well as the first online journal on patients' safety, WebM&M (www.webmm.ahrq.gov). The journal highlights five cases of errors or near misses each month, along with the strategies deployed to prevent recurrence and commentary from national experts.8 Some successful practices in reducing errors have been highlighted by the John M Eisenberg patient safety award of the Joint Commission on Accreditation of Healthcare Organisations. The National Patient Safety Agency has produced a toolkit that includes learning modules to help in analysing root causes.9 The implementation of information technology also offers great promise. Recently, the Institute of Medicine called for the continued development of a national health information infrastructure, providing real time access to complete information on patients and decision support.10 In 2004 the Agency for Healthcare Research and Quality plans on spending nearly $60m to support research and implementation of information technology that improves patient safety. Moreover, the United States Department of Health and Human Services and other purchasers are collaborating to identify incentives to accelerate the use of health information technology. These efforts, coupled with the transformation of the NHS through implementation of a national information technology infrastructure, will accelerate the impact on safety. Despite these steps, we have not seen substantial progress in one critical area—culture—that has the greatest potential to produce sustainable improvements in safety. Both the National Patient Safety Agency and the National Quality Forum, a US public and private consensus development organisation, list a safety culture among its priorities for a safer healthcare system. Culture encompasses commitment to open communication about errors to encourage reporting and analysis. Prerequisite to such openness is the recognition that errors usually result from an imperfect system and that dealing with them through individual blame only discourages reporting. Ensuring openness also entails alignment between the legal and medical staffs; but the medical profession has not embraced the concept that medical error is a systems issue. One study found that 55% of doctors and the public blamed individual health professionals for serious medical errors.11 Similarly, open communication around errors is still not the norm. Liam Donaldson, England's chief medical officer, recently termed the safety culture “weak.”12 Although the concept of culture may be somewhat nebulous, methods exist to assess where an organisation stands. From the first day of medical school, we are taught: Primum non nocere—above all, do no harm. In recent years, healthcare professionals have awoken to the harm our patients are experiencing despite our best intentions. Through the work of many worldwide, our understanding of the epidemic has increased tremendously and is beginning to pay dividends. More substantial and sustainable improvements, however, will occur only when healthcare organisations truly commit to safety through open communication that does not blame individuals but identifies and addresses flaws in systems.

Outcomes and effectiveness research: capacity building for nurse researchers at the Agency for Healthcare Research and Quality.

Abstract: Several of AHRQ's priority areas including disease prevention, health promotion, primary care, quality of care, service delivery, and patient safety are particularly relevant to nurse researchers. With much national attention focused on nursing-related issues such as staff shortages, training, mandatory overtime, working conditions, and autonomy, it is mandatory that nursing research be conducted to inform healthcare delivery and policy. Nurses also need to contribute to the health services literature so that an even balance of discipline perspective is represented. AHRQ's mandate is represented by the slogan "quality research for quality health care." Although our understanding has expanded of contributors to and determinants of evidence-based practice and the relationship between clinical care and improved outcomes, we have much to learn. Appreciating how and which components of nursing care influence patient outcomes represents an essential area of research in need of development. While clarifying nursing contributions to improved outcomes is not the sole purview of nurse researchers, it is plausible to assume that a clinical background in nursing combined with strong methodological skills can help policy makers and health system leaders understand how nurses can most effectively contribute to outcomes and quality improvement. AHRQ is clearly interested in capacity building of researchers from all relevant disciplines. Nurses, the largest provider of healthcare, need to build capacity and develop a much stronger presence in the health services research community of scholars.

Purposeful Sampling for Qualitative Data Collection and Analysis in Mixed Method Implementation Research.

Abstract: Purposeful sampling is widely used in qualitative research for the identification and selection of information-rich cases related to the phenomenon of interest. Although there are several different purposeful sampling strategies, criterion sampling appears to be used most commonly in implementation research. However, combining sampling strategies may be more appropriate to the aims of implementation research and more consistent with recent developments in quantitative methods. This paper reviews the principles and practice of purposeful sampling in implementation research, summarizes types and categories of purposeful sampling strategies and provides a set of recommendations for use of single strategy or multistage strategy designs, particularly for state implementation research.

Effectiveness of Antipsychotic Drugs in Patients with Chronic Schizophrenia

Abstract: background The relative effectiveness of second-generation (atypical) antipsychotic drugs as compared with that of older agents has been incompletely addressed, though newer agents are currently used far more commonly. We compared a first-generation antipsychotic, perphenazine, with several newer drugs in a double-blind study. methods A total of 1493 patients with schizophrenia were recruited at 57 U.S. sites and randomly assigned to receive olanzapine (7.5 to 30 mg per day), perphenazine (8 to 32 mg per day), quetiapine (200 to 800 mg per day), or risperidone (1.5 to 6.0 mg per day) for up to 18 months. Ziprasidone (40 to 160 mg per day) was included after its approval by the Food and Drug Administration. The primary aim was to delineate differences in the overall effectiveness of these five treatments. results Overall, 74 percent of patients discontinued the study medication before 18 months (1061 of the 1432 patients who received at least one dose): 64 percent of those assigned to olanzapine, 75 percent of those assigned to perphenazine, 82 percent of those assigned to quetiapine, 74 percent of those assigned to risperidone, and 79 percent of those assigned to ziprasidone. The time to the discontinuation of treatment for any cause was significantly longer in the olanzapine group than in the quetiapine (P<0.001) or risperidone (P=0.002) group, but not in the perphenazine (P=0.021) or ziprasidone (P=0.028) group. The times to discontinuation because of intolerable side effects were similar among the groups, but the rates differed (P=0.04); olanzapine was associated with more discontinuation for weight gain or metabolic effects, and perphenazine was associated with more discontinuation for extrapyramidal effects. conclusions The majority of patients in each group discontinued their assigned treatment owing to inefficacy or intolerable side effects or for other reasons. Olanzapine was the most effective in terms of the rates of discontinuation, and the efficacy of the conventional antipsychotic agent perphenazine appeared similar to that of quetiapine, risperidone, and ziprasidone. Olanzapine was associated with greater weight gain and increases in measures of glucose and lipid metabolism.

Lifestyle, Diabetes, and Cardiovascular Risk Factors 10 Years after Bariatric Surgery

Abstract: Background Weight loss is associated with short-term amelioration and prevention of metabolic and cardiovascular risk, but whether these benefits persist over time is unknown. Methods The prospective, controlled Swedish Obese Subjects Study involved obese subjects who underwent gastric surgery and contemporaneously matched, conventionally treated obese control subjects. We now report follow-up data for subjects (mean age, 48 years; mean body-mass index, 41) who had been enrolled for at least 2 years (4047 subjects) or 10 years (1703 subjects) before the analysis (January 1, 2004). The follow-up rate for laboratory examinations was 86.6 percent at 2 years and 74.5 percent at 10 years. Results After two years, the weight had increased by 0.1 percent in the control group and had decreased by 23.4 percent in the surgery group (P<0.001). After 10 years, the weight had increased by 1.6 percent and decreased by 16.1 percent, respectively (P<0.001). Energy intake was lower and the proportion of physically active ...

Effectiveness-implementation Hybrid Designs: Combining Elements of Clinical Effectiveness and Implementation Research to Enhance Public Health Impact

Abstract: Objectives:This study proposes methods for blending design components of clinical effectiveness and implementation research. Such blending can provide benefits over pursuing these lines of research independently; for example, more rapid translational gains, more effective implementation strategies,

Developing and Evaluating Complex Interventions: New Guidance

Abstract: Peter Craig, MRC Population Health Sciences Research Network Paul Dieppe, Nuffield Department of Orthopaedic Surgery, University of Oxford Sally Macintyre, MRC Social and Public Health Sciences Unit Susan Michie, Centre for Outcomes Research and Effectiveness, University College London Irwin Nazareth, MRC General Practice Research Framework Mark Petticrew, Department of Public Health and Policy, London School of Hygiene and Tropical Medicine