Patient Compliance in Medical Practice and Clinical Trials

Patient Compliance in Medical Practice and Clinical Trials PDF Author: Joyce A. Cramer
Publisher: Lippincott Williams & Wilkins
ISBN:
Category : Medical
Languages : en
Pages : 440

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Book Description
Patient noncompliance with medical regimens is a major factor in therapeutic failure and is particularly detrimental to clinical trials.

Patient Compliance in Medical Practice and Clinical Trials

Patient Compliance in Medical Practice and Clinical Trials PDF Author: Joyce A. Cramer
Publisher: Lippincott Williams & Wilkins
ISBN:
Category : Medical
Languages : en
Pages : 440

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Book Description
Patient noncompliance with medical regimens is a major factor in therapeutic failure and is particularly detrimental to clinical trials.

The Prevention and Treatment of Missing Data in Clinical Trials

The Prevention and Treatment of Missing Data in Clinical Trials PDF Author: National Research Council
Publisher: National Academies Press
ISBN: 030918651X
Category : Medical
Languages : en
Pages : 163

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Book Description
Randomized clinical trials are the primary tool for evaluating new medical interventions. Randomization provides for a fair comparison between treatment and control groups, balancing out, on average, distributions of known and unknown factors among the participants. Unfortunately, these studies often lack a substantial percentage of data. This missing data reduces the benefit provided by the randomization and introduces potential biases in the comparison of the treatment groups. Missing data can arise for a variety of reasons, including the inability or unwillingness of participants to meet appointments for evaluation. And in some studies, some or all of data collection ceases when participants discontinue study treatment. Existing guidelines for the design and conduct of clinical trials, and the analysis of the resulting data, provide only limited advice on how to handle missing data. Thus, approaches to the analysis of data with an appreciable amount of missing values tend to be ad hoc and variable. The Prevention and Treatment of Missing Data in Clinical Trials concludes that a more principled approach to design and analysis in the presence of missing data is both needed and possible. Such an approach needs to focus on two critical elements: (1) careful design and conduct to limit the amount and impact of missing data and (2) analysis that makes full use of information on all randomized participants and is based on careful attention to the assumptions about the nature of the missing data underlying estimates of treatment effects. In addition to the highest priority recommendations, the book offers more detailed recommendations on the conduct of clinical trials and techniques for analysis of trial data.

Small Clinical Trials

Small Clinical Trials PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309171148
Category : Medical
Languages : en
Pages : 221

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Book Description
Clinical trials are used to elucidate the most appropriate preventive, diagnostic, or treatment options for individuals with a given medical condition. Perhaps the most essential feature of a clinical trial is that it aims to use results based on a limited sample of research participants to see if the intervention is safe and effective or if it is comparable to a comparison treatment. Sample size is a crucial component of any clinical trial. A trial with a small number of research participants is more prone to variability and carries a considerable risk of failing to demonstrate the effectiveness of a given intervention when one really is present. This may occur in phase I (safety and pharmacologic profiles), II (pilot efficacy evaluation), and III (extensive assessment of safety and efficacy) trials. Although phase I and II studies may have smaller sample sizes, they usually have adequate statistical power, which is the committee's definition of a "large" trial. Sometimes a trial with eight participants may have adequate statistical power, statistical power being the probability of rejecting the null hypothesis when the hypothesis is false. Small Clinical Trials assesses the current methodologies and the appropriate situations for the conduct of clinical trials with small sample sizes. This report assesses the published literature on various strategies such as (1) meta-analysis to combine disparate information from several studies including Bayesian techniques as in the confidence profile method and (2) other alternatives such as assessing therapeutic results in a single treated population (e.g., astronauts) by sequentially measuring whether the intervention is falling above or below a preestablished probability outcome range and meeting predesigned specifications as opposed to incremental improvement.

The Role of Purchasers and Payers in the Clinical Research Enterprise

The Role of Purchasers and Payers in the Clinical Research Enterprise PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309182905
Category : Medical
Languages : en
Pages : 120

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Book Description
In a workshop organized by the Clinical Research roundtable, representatives from purchaser organizations (employers), payer organizations (health plans and insurance companies), and other stakeholder organizations (voluntary health associations, clinical researchers, research organizations, and the technology community) came together to explore: What do purchasers and payers need from the Clinical Research Enterprise? How have current efforts in clinical research met their needs? What are purchasers, payers, and other stakeholders willing to contribute to the enterprise? This book documents these discussions and summarizes what employers and insurers need from and are willing to contribute to clinical research from both a business and a national health care perspective.

The Wiley Handbook of Healthcare Treatment Engagement

The Wiley Handbook of Healthcare Treatment Engagement PDF Author: Andrew Hadler
Publisher: John Wiley & Sons
ISBN: 1119129524
Category : Medical
Languages : en
Pages : 667

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Book Description
Winner of the 2021 PROSE Award for CLINICAL PSYCHOLOGY and PSYCHIATRY Against a global backdrop of problematic adherence to medical treatment, this volume addresses and provides practical solutions to the simple question: "Why don't patients take treatments that could save their lives?" The Wiley handbook of Healthcare Treatment Engagement offers a guide to the theory, research and clinical practice of promoting patient engagement in healthcare treatment at individual, organizational and systems levels. The concept of treatment engagement, as explained within the text, promotes a broader view than the related concept of treatment adherence. Treatment engagement encompasses more readily the lifestyle factors which may impact healthcare outcomes as much as medication-taking, as well as practical, economic and cultural factors which may determine access to treatment. Over a span of 32 chapters, an international panel of expert authors address this far-reaching and fascinating field, describing a broad range of evidence-based approaches which stand to improve clinical services and treatment outcomes, as well as the experience of users of healthcare service and practitioners alike. This comprehensive volume adopts an interdisciplinary approach to offer an understanding of the factors governing our healthcare systems and the motivations and behaviors of patients, clinicians and organizations. Presented in a user-friendly format for quick reference, the text first supports the reader’s understanding by exploring background topics such as the considerable impact of sub-optimal treatment adherence on healthcare outcomes, before describing practical clinical approaches to promote engagement in treatment, including chapters referring to specific patient populations. The text recognizes the support which may be required throughout the depth of each healthcare organization to promote patient engagement, and in the final section of the book, describes approaches to inform the development of healthcare services with which patients will be more likely to seek to engage. This important book: Provides a comprehensive summary of practical approaches developed across a wide range of clinical settings, integrating research findings and clinical literature from a variety of disciplines Introduces and compliments existing approaches to improve communication in healthcare settings and promote patient choice in planning treatment Presents a range of proven clinical solutions that will appeal to those seeking to improve outcomes on a budget Written for health professionals from all disciplines of clinical practice, as well as service planners and policy makers, The Wiley Handbook of Healthcare Treatment Engagement is a comprehensive guide for individual practitioners and organizations alike. 2021 PROSE Biological and Life Sciences Category for Clinical Psychology & Psychiatry

Compliance with Therapeutic Regimens

Compliance with Therapeutic Regimens PDF Author: R. Brian Haynes
Publisher: Baltimore : Johns Hopkins University Press
ISBN:
Category : Health & Fitness
Languages : en
Pages : 320

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Book Description


Registries for Evaluating Patient Outcomes

Registries for Evaluating Patient Outcomes PDF Author: Agency for Healthcare Research and Quality/AHRQ
Publisher: Government Printing Office
ISBN: 1587634333
Category : Medical
Languages : en
Pages : 385

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Book Description
This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Facilitating Treatment Adherence

Facilitating Treatment Adherence PDF Author: Donald Meichenbaum
Publisher: Springer
ISBN: 9781468453614
Category : Psychology
Languages : en
Pages : 0

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Book Description


Handbook of Health Behavior Research II

Handbook of Health Behavior Research II PDF Author: David S. Gochman
Publisher: Springer Science & Business Media
ISBN: 9780306454448
Category : Health & Fitness
Languages : en
Pages : 560

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Book Description
This landmark treatise provides the first comprehensive review of basic health behavior research. In four volumes, multidisciplinary contributors critically assess every aspect of health behavior, giving special attention to the interrelationship between personal/social systems and risk behavior. Volume 1 presents useful conceptions of health and health behavior and describes the influence of personal, family, social and institutional factors. Each volume features extensive supplementary and integrative material prepared by the editor, the detailed index to the entire four-volume set, and a glossary of health behavior terminology.

Extending Medicare Reimbursement in Clinical Trials

Extending Medicare Reimbursement in Clinical Trials PDF Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309068886
Category : Medical
Languages : en
Pages : 86

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Book Description
Increasingly over the past five years, uncertainty about reimbursement for routine patient care has been suspected as contributing to problems enrolling people in clinical trials. Clinical trial investigators cannot guarantee that Medicare will pay for the care required, and they must disclose this uncertainty to potential participants during the informed consent process. Since Medicare does not routinely "preauthorize" care (as do many commercial insurers) the uncertainty cannot be dispelled in advance. Thus, patients considering whether to enter trials must assume that they may have to pay bills that Medicare rejects simply because they have enrolled in the trial. This report recommends an explicit policy for reimbursement of routine patient care costs in clinical trials. It further recommends that HCFA provide additional support for selected clinical trials, and that the government support the establishment of a national clinical trials registry. These policies (1) should assure that beneficiaries would not be denied coverage merely because they have volunteered to participate in a clinical trial; and (2) would not impose excessive administrative burdens on HCFA, its fiscal intermediaries and carriers, or investigators, providers, or participants in clinical trials. Explicit rules would have the added benefit of increasing the uniformity of reimbursement decisions made by Medicare fiscal intermediaries and carriers in different parts of the country. Greater uniformity would, in turn, decrease the uncertainty about reimbursement when providers and patients embark on a clinical trial.