Browsing by Subject "Guidelines as Topic"

Now showing 1 - 18 of 18

Open Access
10 Years with ICH E10: Choice of Control Groups.
(Pharm Stat, 2011-09) Rockhold, Frank W; Enas, Gregory G
Open Access
Assessing applicability when comparing medical interventions: AHRQ and the Effective Health Care Program.
(Journal of clinical epidemiology, 2011-11) Atkins, David; Chang, Stephanie M; Gartlehner, Gerald; Buckley, David I; Whitlock, Evelyn P; Berliner, Elise; Matchar, David
Objective
To describe a systematic approach for identifying, reporting, and synthesizing information to allow consistent and transparent consideration of the applicability of the evidence in a systematic review according to the Population, Intervention, Comparator, Outcome, Setting domains.
Study design and setting
Comparative effectiveness reviews need to consider whether available evidence is applicable to specific clinical or policy questions to be useful to decision makers. Authors reviewed the literature and developed guidance for the Effective Health Care program.
Results
Because applicability depends on the specific questions and needs of the users, it is difficult to devise a valid uniform scale for rating the overall applicability of individual studies or body of evidence. We recommend consulting stakeholders to identify the factors most relevant to applicability for their decisions. Applicability should be considered separately for benefits and harms. Observational studies can help determine whether trial populations and interventions are representative of "real world" practice. Reviewers should describe differences between available evidence and the ideally applicable evidence for the question being asked and offer a qualitative judgment about the importance and potential effect of those differences.
Conclusion
Careful consideration of applicability may improve the usefulness of systematic reviews in informing practice and policy.
Open Access
Chapter 11: challenges in and principles for conducting systematic reviews of genetic tests used as predictive indicators.
(Journal of general internal medicine, 2012-06) Jonas, Daniel E; Wilt, Timothy J; Taylor, Brent C; Wilkins, Tania M; Matchar, David B
In this paper, we discuss common challenges in and principles for conducting systematic reviews of genetic tests. The types of genetic tests discussed are those used to 1). determine risk or susceptibility in asymptomatic individuals; 2). reveal prognostic information to guide clinical management in those with a condition; or 3). predict response to treatments or environmental factors. This paper is not intended to provide comprehensive guidance on evaluating all genetic tests. Rather, it focuses on issues that have been of particular concern to analysts and stakeholders and on areas that are of particular relevance for the evaluation of studies of genetic tests. The key points include: The general principles that apply in evaluating genetic tests are similar to those for other prognostic or predictive tests, but there are differences in how the principles need to be applied or the degree to which certain issues are relevant. A clear definition of the clinical scenario and an analytic framework is important when evaluating any test, including genetic tests. Organizing frameworks and analytic frameworks are useful constructs for approaching the evaluation of genetic tests. In constructing an analytic framework for evaluating a genetic test, analysts should consider preanalytic, analytic, and postanalytic factors; such factors are useful when assessing analytic validity. Predictive genetic tests are generally characterized by a delayed time between testing and clinically important events. Finding published information on the analytic validity of some genetic tests may be difficult. Web sites (FDA or diagnostic companies) and gray literature may be important sources. In situations where clinical factors associated with risk are well characterized, comparative effectiveness reviews should assess the added value of using genetic testing along with known factors compared with using the known factors alone. For genome-wide association studies, reviewers should determine whether the association has been validated in multiple studies to minimize both potential confounding and publication bias. In addition, reviewers should note whether appropriate adjustments for multiple comparisons were used.
Open Access
Chapter 1: Introduction to the Methods Guide for Medical Test Reviews.
(Journal of general internal medicine, 2012-06) Matchar, David B
Evaluation of medical tests presents challenges distinct from those involved in the evaluation of therapies; in particular, the very great importance of context and the dearth of comprehensive RCTs aimed at comparing the clinical outcomes of different tests and test strategies. Available guidance provides some suggestions: 1) Use of the PICOTS typology for clarifying the context relevant to the review, and 2) use of an organizing framework for classifying the types of medical test evaluation studies and their relationship to potential key questions. However, there is a diversity of recommendations for reviewers of medical tests and a proliferation of concepts, terms, and methods. As a contribution to the field, this Methods Guide for Medical Test Reviews seeks to provide practical guidance for achieving the goals of clarity, consistency, tractability, and usefulness.
Open Access
Chapter 5: assessing risk of bias as a domain of quality in medical test studies.
(Journal of general internal medicine, 2012-06) Santaguida, P Lina; Riley, Crystal M; Matchar, David B
Assessing methodological quality is a necessary activity for any systematic review, including those evaluating the evidence for studies of medical test performance. Judging the overall quality of an individual study involves examining the size of the study, the direction and degree of findings, the relevance of the study, and the risk of bias in the form of systematic error, internal validity, and other study limitations. In this chapter of the Methods Guide for Medical Test Reviews, we focus on the evaluation of risk of bias in the form of systematic error in an individual study as a distinctly important component of quality in studies of medical test performance, specifically in the context of estimating test performance (sensitivity and specificity). We make the following recommendations to systematic reviewers: 1) When assessing study limitations that are relevant to the test under evaluation, reviewers should select validated criteria that examine the risk of systematic error, 2) categorizing the risk of bias for individual studies as "low," "medium," or "high" is a useful way to proceed, and 3) methods for determining an overall categorization for the study limitations should be established a priori and documented clearly.
Open Access
Chapter 6: assessing applicability of medical test studies in systematic reviews.
(Journal of general internal medicine, 2012-06) Hartmann, KE; Matchar, DB; Chang, S
Use of medical tests should be guided by research evidence about the accuracy and utility of those tests in clinical care settings. Systematic reviews of the literature about medical tests must address applicability to real-world decision-making. Challenges for reviews include: (1) lack of clarity in key questions about the intended applicability of the review, (2) numerous studies in many populations and settings, (3) publications that provide too little information to assess applicability, (4) secular trends in prevalence and the spectrum of the condition for which the test is done, and (5) changes in the technology of the test itself. We describe principles for crafting reviews that meet these challenges and capture the key elements from the literature necessary to understand applicability.
Open Access
Chapter 7: grading a body of evidence on diagnostic tests.
(Journal of general internal medicine, 2012-06) Singh, Sonal; Chang, Stephanie M; Matchar, David B; Bass, Eric B
Introduction
Grading the strength of a body of diagnostic test evidence involves challenges over and above those related to grading the evidence from health care intervention studies. This chapter identifies challenges and outlines principles for grading the body of evidence related to diagnostic test performance.
Challenges
Diagnostic test evidence is challenging to grade because standard tools for grading evidence were designed for questions about treatment rather than diagnostic testing; and the clinical usefulness of a diagnostic test depends on multiple links in a chain of evidence connecting the performance of a test to changes in clinical outcomes.
Principles
Reviewers grading the strength of a body of evidence on diagnostic tests should consider the principle domains of risk of bias, directness, consistency, and precision, as well as publication bias, dose response association, plausible unmeasured confounders that would decrease an effect, and strength of association, similar to what is done to grade evidence on treatment interventions. Given that most evidence regarding the clinical value of diagnostic tests is indirect, an analytic framework must be developed to clarify the key questions, and strength of evidence for each link in that framework should be graded separately. However if reviewers choose to combine domains into a single grade of evidence, they should explain their rationale for a particular summary grade and the relevant domains that were weighed in assigning the summary grade.
Open Access
Ethical Issues and Recommendations in Grateful Patient Fundraising and Philanthropy.
(Academic medicine : journal of the Association of American Medical Colleges, 2018-11) Collins, Megan E; Rum, Steven; Wheeler, Jane; Antman, Karen; Brem, Henry; Carrese, Joseph; Glennon, Michelle; Kahn, Jeffrey; Ohman, E Magnus; Jagsi, Reshma; Konrath, Sara; Tovino, Stacey; Wright, Scott; Sugarman, Jeremy; Participants in the Summit on the Ethics of Grateful Patient Fundraising
Grateful patients provide substantial philanthropic funding for health care institutions, resulting in important societal benefits. Although grateful patient fundraising (GPFR) is widespread, it raises an array of ethical issues for patients, physicians, development professionals, and institutions. These issues have not been described comprehensively, and there is insufficient guidance to inform the ethical practice of GPFR. Consequently, the authors convened a "Summit on the Ethics of Grateful Patient Fundraising," with the goal of identifying primary ethical issues in GPFR and offering recommendations regarding how to manage them. Participants were 29 experts from across the United States who represented the perspectives of bioethics, clinical practice, development, law, patients, philanthropy, psychology, and regulatory compliance. Intensive discussions resulted in articulating ethical issues for physicians and other clinicians (discussions with patients about philanthropy; physician-initiated discussions; clinically vulnerable patients; conflicts of obligation and equity regarding physician's time, attention, and responsiveness and the provision of special services; and transparency and respecting donor intent) as well as for development officers and institutions (transparency in the development professional-donor relationship; impact on clinical care; confidentiality and privacy; conflicts of interest; institution-patient/donor relationship; concierge services for grateful patients; scientific merit and research integrity; transparency in use of philanthropic gifts; and institutional policies and training in responsible GPFR). While these recommendations promise to mitigate some of the ethical issues associated with GPFR, important next steps include conducting research on the ethical issues in GPFR, disseminating these recommendations, developing standardized training for clinicians regarding them, and revising them as warranted.
Unknown
Global guideline for the diagnosis and management of the endemic mycoses: an initiative of the European Confederation of Medical Mycology in cooperation with the International Society for Human and Animal Mycology.
(The Lancet. Infectious diseases, 2021-12) Thompson, George R; Le, Thuy; Chindamporn, Ariya; Kauffman, Carol A; Alastruey-Izquierdo, Ana; Ampel, Neil M; Andes, David R; Armstrong-James, Darius; Ayanlowo, Olusola; Baddley, John W; Barker, Bridget M; Lopes Bezerra, Leila; Buitrago, Maria J; Chamani-Tabriz, Leili; Chan, Jasper FW; Chayakulkeeree, Methee; Cornely, Oliver A; Cunwei, Cao; Gangneux, Jean-Pierre; Govender, Nelesh P; Hagen, Ferry; Hedayati, Mohammad T; Hohl, Tobias M; Jouvion, Grégory; Kenyon, Chris; Kibbler, Christopher C; Klimko, Nikolai; Kong, David CM; Krause, Robert; Lee Lee, Low; Meintjes, Graeme; Miceli, Marisa H; Rath, Peter-Michael; Spec, Andrej; Queiroz-Telles, Flavio; Variava, Ebrahim; Verweij, Paul E; Schwartz, Ilan S; Pasqualotto, Alessandro C
The global burden of the endemic mycoses (blastomycosis, coccidioidomycosis, emergomycosis, histoplasmosis, paracoccidioidomycosis, sporotrichosis, and talaromycosis) continues to rise yearly and these infectious diseases remain a leading cause of patient morbidity and mortality worldwide. Management of the associated pathogens requires a thorough understanding of the epidemiology, risk factors, diagnostic methods and performance characteristics in different patient populations, and treatment options unique to each infection. Guidance on the management of these infections has the potential to improve prognosis. The recommendations outlined in this Review are part of the "One World, One Guideline" initiative of the European Confederation of Medical Mycology. Experts from 23 countries contributed to the development of these guidelines. The aim of this Review is to provide an up-to-date consensus and practical guidance in clinical decision making, by engaging physicians and scientists involved in various aspects of clinical management.
Unknown
Identification of chest pain patients appropriate for an emergency department observation unit.
(Emergency medicine clinics of North America, 2001-02) Wilkinson, K; Severance, H
There are no perfect tests or algorithms to exclude ACI. Because acute coronary occlusion often occurs in patients with low-grade coronary stenosis, the diagnostic goal of a chest pain diagnostic protocol is not to identify patients with CAD, but rather to identify patients who may be safely discharged home without the development of complications such as MI, unstable angina, death, shock, or CHF over the next 1 to 6 months. There is an advantage to evaluating patients at the time of their symptoms. Patients who have a small plaque that is ruptured, leading to intracoronary thrombosis and ischemia, will manifest ischemia on diagnostic testing that could missed in routine outpatient testing when their plaque were stable. The diagnosis and risk stratification of acute coronary ischemia in the ED depends on a careful history and interpretation of the ECG. Multiple regression models using readily available data (e.g., history, physical examination, and ECG) provide the best tools for risk stratification. If one is deciding how to select patients for an EDOU chest pain evaluation, diagnostic tools that have previously been tested and validated in this setting are preferable. These include the Multicenter Chest Pain Study derived tools (i.e., Goldman, Lee), the ACI and ACI-TIPI tools, and sestamibi risk stratification tools. This is not to say that other tools may not play a role at individual institutions. It is probably better to select a consistent approach and evaluate its performance, rather than to allow random variation to dictate practice. The future direction probably will involve standardization of the ED chest pain population. This allows outcome and cost-effectiveness comparative research of various strategies for patients with normal or nondiagnostic ECGs and normal biomarkers. Although this approach allows more precise stratification, the risk will never be zero, meaning that there will never be a substitute for good clinical judgment and close follow-up care.
Unknown
Issues in regulatory guidelines for data monitoring committees.
(Clin Trials, 2004) DeMets, David; Califf, Robert; Dixon, Dennis; Ellenberg, Susan; Fleming, Thomas; Held, Peter; Julian, Desmond; Kaplan, Richard; Levine, Robert; Neaton, James; Packer, Milton; Pocock, Stuart; Rockhold, Frank; Seto, Belinda; Siegel, Jay; Snapinn, Steve; Stump, David; Temple, Robert; Whitley, Richard
As clinical trials have emerged as the major research method for evaluating new interventions, the process for monitoring intervention safety and benefit has also evolved. The Data Monitoring Committee (DMC) has become the standard approach to implement this responsibility for many Phase III trials. Recent draft guidelines on the operation of DMCs by the Food and Drug Administration (FDA) have raised issues that need further clarification or discussion, especially for industry sponsored trials. These include, the time when DMCs are needed, the role of the independent statistician to support the DMC, and sponsor participation at DMC meetings. This paper provides an overview of these issues, based on the discussions at the January, 2003 workshop sponsored by Duke Clinical Research Institute.
Unknown
Leave no one behind: response to new evidence and guidelines for the management of cryptococcal meningitis in low-income and middle-income countries.
(The Lancet. Infectious Diseases, 2019-04) Loyse, Angela; Burry, Jessica; Cohn, Jennifer; Ford, Nathan; Chiller, Tom; Ribeiro, Isabela; Koulla-Shiro, Sinata; Mghamba, Janneth; Ramadhani, Angela; Nyirenda, Rose; Aliyu, Sani H; Wilson, Douglas; Le, Thuy; Oladele, Rita; Lesikari, Sokoine; Muzoora, Conrad; Kalata, Newton; Temfack, Elvis; Mapoure, Yacouba; Sini, Victor; Chanda, Duncan; Shimwela, Meshack; Lakhi, Shabir; Ngoma, Jonathon; Gondwe-Chunda, Lilian; Perfect, Chase; Shroufi, Amir; Andrieux-Meyer, Isabelle; Chan, Adrienne; Schutz, Charlotte; Hosseinipour, Mina; Van der Horst, Charles; Klausner, Jeffrey D; Boulware, David R; Heyderman, Robert; Lalloo, David; Day, Jeremy; Jarvis, Joseph N; Rodrigues, Marcio; Jaffar, Shabbar; Denning, David; Migone, Chantal; Doherty, Megan; Lortholary, Olivier; Dromer, Françoise; Stack, Muirgen; Molloy, Síle F; Bicanic, Tihana; van Oosterhout, Joep; Mwaba, Peter; Kanyama, Cecilia; Kouanfack, Charles; Mfinanga, Sayoki; Govender, Nelesh; Harrison, Thomas S
In 2018, WHO issued guidelines for the diagnosis, prevention, and management of HIV-related cryptococcal disease. Two strategies are recommended to reduce the high mortality associated with HIV-related cryptococcal meningitis in low-income and middle-income countries (LMICs): optimised combination therapies for confirmed meningitis cases and cryptococcal antigen screening programmes for ambulatory people living with HIV who access care. WHO's preferred therapy for the treatment of HIV-related cryptococcal meningitis in LMICs is 1 week of amphotericin B plus flucytosine, and the alternative therapy is 2 weeks of fluconazole plus flucytosine. In the ACTA trial, 1-week (short course) amphotericin B plus flucytosine resulted in a 10-week mortality of 24% (95% CI -16 to 32) and 2 weeks of fluconazole and flucytosine resulted in a 10-week mortality of 35% (95% CI -29 to 41). However, with widely used fluconazole monotherapy, mortality because of HIV-related cryptococcal meningitis is approximately 70% in many African LMIC settings. Therefore, the potential to transform the management of HIV-related cryptococcal meningitis in resource-limited settings is substantial. Sustainable access to essential medicines, including flucytosine and amphotericin B, in LMICs is paramount and the focus of this Personal View.
Unknown
Medication adherence: A practical measurement selection guide using case studies.
(Patient education and counseling, 2017-07) Zullig, Leah L; Mendys, Phil; Bosworth, Hayden B
Objectives
Medication adherence is a complex problem and can be evaluated using a variety of methods. There is no single or perfect strategy to assess adherence. The "best" measure depends on contextual factors. Our objective is to provide a practical, illustrative guide for selecting the most appropriate measure of medication adherence in common contexts.
Methods
We present three case studies - from the perspectives of an academic researcher, health care payer, and clinical care provider - to describe common problems and processes for measuring medication adherence, as well as proposing possible solutions.
Results
The most appropriate measure will depend on the context (tightly controlled clinical trial setting vs. clinical setting), intended purpose (research vs. clinical), available resources (data, personnel, materials, and funding), time (quick screening vs. comprehensive review), and phase of interest (initiation, implementation, or discontinuation). Framing the problem of medication non-adherence and methods for measuring adherence are discussed using three representative case studies.
Conclusions
A simple tool is provided that may help stakeholders interested in medication adherence make decisions regarding the appropriate selection of measures.
Practice implications
A medication adherence measure should be selected through the lens of each situation's unique objectives, resources, and needs.
Unknown
Methods guide for authors of systematic reviews of medical tests: a collaboration between the Agency for Healthcare Research and Quality (AHRQ) and the Journal of General Internal Medicine.
(Journal of general internal medicine, 2012-06) Smetana, Gerald W; Umscheid, Craig A; Chang, Stephanie; Matchar, David B
Unknown
Microdosing and drug development: past, present and future.
(Expert Opin Drug Metab Toxicol, 2013-07) Lappin, Graham; Noveck, Robert; Burt, Tal
INTRODUCTION: Microdosing is an approach to early drug development where exploratory pharmacokinetic data are acquired in humans using inherently safe sub-pharmacologic doses of drug. The first publication of microdose data was 10 years ago and this review comprehensively explores the microdose concept from conception, over the past decade, up until the current date. AREAS COVERED: The authors define and distinguish the concept of microdosing from similar approaches. The authors review the ability of microdosing to provide exploratory pharmacokinetics (concentration-time data) but exclude microdosing using positron emission tomography. The article provides a comprehensive review of data within the peer-reviewed literature as well as the latest applications and a look into the future, towards where microdosing may be headed. EXPERT OPINION: Evidence so far suggests that microdosing may be a better predictive tool of human pharmacokinetics than alternative methods and combination with physiologically based modelling may lead to much more reliable predictions in the future. The concept has also been applied to drug-drug interactions, polymorphism and assessing drug concentrations over time at its site of action. Microdosing may yet have more to offer in unanticipated directions and provide benefits that have not been fully realised to date.
Open Access
Reporting standards for literature searches and report inclusion criteria: making research syntheses more transparent and easy to replicate.
(Res Synth Methods, 2015-03) Atkinson, Kayla M; Koenka, Alison C; Sanchez, Carmen E; Moshontz, Hannah; Cooper, Harris
A complete description of the literature search, including the criteria used for the inclusion of reports after they have been located, used in a research synthesis or meta-analysis is critical if subsequent researchers are to accurately evaluate and reproduce a synthesis' methods and results. Based on previous guidelines and new suggestions, we present a set of focused and detailed standards for reporting the methods used in a literature search. The guidelines cover five search strategies: reference database searches, journal and bibliography searches, searches of the reference lists of reports, citation searches, and direct contact searches. First, we bring together all the unique recommendations made in existing guidelines for research synthesis. Second, we identify gaps in reporting standards for search strategies. Third, we address these gaps by providing new reporting recommendations. Our hope is to facilitate successful evaluation and replication of research synthesis results.
Open Access
Therapy and clinical trials.
(Curr Opin Lipidol, 2014-10) Chongthammakun, Vasutakarn; Krasuski, Richard A
Open Access
Umbilical cord blood: a guide for primary care physicians.
(American family physician, 2011-09) Martin, Paul L; Kurtzberg, Joanne; Hesse, Brett
Umbilical cord blood stem cell transplants are used to treat a variety of oncologic, genetic, hematologic, and immunodeficiency disorders. Physicians have an important role in educating, counseling, and offering umbilical cord blood donation and storage options to patients. Parents may donate their infant's cord blood to a public bank, pay to store it in a private bank, or have it discarded. The federal government and many state governments have passed laws and issued regulations regarding umbilical cord blood, and some states require physicians to discuss cord blood options with pregnant women. Five prominent medical organizations have published recommendations about cord blood donation and storage. Current guidelines recommend donation of umbilical cord blood to public banks when possible, or storage through the Related Donor Cord Blood Program when a sibling has a disease that may require a stem cell transplant. Experts do not currently recommend private banking for unidentified possible future use. Step-by-step guidance and electronic resources are available to physicians whose patients are considering saving or donating their infant's umbilical cord blood.

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