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The Oxford Handbook of Research Strategies for Clinical Psychology
To continue to move the science of clinical psychology forward, this handbook brings together some of the field's foremost experts to explicate the essential research strategies currently used across the modern clinical psychology landscape that maximize both precision and significance. This volume addresses design, measurement, and analytic strategies for clinical psychology, including comprehensive coverage of effective laboratory methods in experimental psychopathology, single-case experimental designs, small pilot trials, the randomized controlled trial, adaptive and modular treatment designs, and dissemination methods and models. Comprehensive chapters cover change measurement, observational coding, measurement of process variables across treatment, structural and functional brain imagining, and experience sampling data collection methods. Specific topics addressed include statistical power, correlation and regression, randomized clinical trial data analysis, conventions in mediation and moderation analysis, structural equation modeling, meta-analytic techniques, item-response theory, and the appropriate handling of missing data. The book concludes with an integrative summary of research strategies addressed across the volume, and guidelines for future directions in research methodology, design, and analysis that will keep this young science moving forward in a manner that maximizes scientific rigor and clinical relevance.
eBook
Intention to treat and per protocol analyses: differences and similarities
Randomized trials can take more explanatory or more pragmatic approaches. Pragmatic studies, conducted closer to real-world conditions, assess treatment effectiveness while considering factors like protocol adherence. In these studies, intention-to-treat (ITT) analysis is fundamental, comparing outcomes regardless of the actual treatment received. Explanatory trials, conducted closer to optimal conditions, evaluate treatment efficacy, commonly with a per protocol (PP) analysis, which includes only outcomes from adherent participants. ITT and PP are strategies used in the conception, design, conduct (protocol execution), analysis, and interpretation of trials. Each serves distinct objectives. While both can be valid, when bias is controlled, and complementary, each has its own limitations. By excluding nonadherent participants, PP analyses can lose the benefits of randomization, resulting in group differences in factors (influencing adherence and outcomes) that were present at baseline. Additionally, clinical and social factors affecting adherence can also operate during follow-up, that is, after randomization. Therefore, incomplete adherence may introduce postrandomization confounding. Conversely, ITT analysis, including all participants regardless of adherence, may dilute treatment effects. Moreover, varying adherence levels could limit the applicability of ITT findings in settings with diverse adherence patterns. Both ITT and PP analyses can be affected by selection bias due to differential losses and nonresponse (ie, missing data) during follow-up. Combining high-quality and comprehensive data with advanced statistical methods, known as g-methods, like inverse probability weighting, may help address postrandomization confounding in PP analysis as well as selection bias in both ITT and PP analyses.
Journal Article
Research using qualitative, quantitative or mixed methods and choice based on the research
Research is fundamental to the advancement of medicine and critical to identifying the most optimal therapies unique to particular societies. This is easily observed through the dynamics associated with pharmacology, surgical technique and the medical equipment used today versus short years ago. Advancements in knowledge synthesis and reporting guidelines enhance the quality, scope and applicability of results; thus, improving health science and clinical practice and advancing health policy. While advancements are critical to the progression of optimal health care, the high cost associated with these endeavors cannot be ignored. Research fundamentally needs to be evaluated to identify the most efficient methods of evaluation. The primary objective of this paper is to look at a specific research methodology when applied to the area of clinical research, especially extracorporeal circulation and its prognosis for the future.
Journal Article
Point-of-Care Clinical Trials in Sports Medicine Research: Identifying Effective Treatment Interventions Through Comparative Effectiveness Research
Recently, calls to conduct comparative effectiveness research (CER) in athletic training to better support patient care decisions have been circulated. Traditional research methods (eg, randomized controlled trials [RCTs], observational studies) may be ill suited for CER. Thus, innovative research methods are needed to support CER efforts.
To discuss the limitations of traditional research designs in CER studies, describe a novel methodologic approach called the point-of-care clinical trial (POC-CT), and highlight components of the POC-CT (eg, incorporation of an electronic medical record [EMR], Bayesian adaptive feature) that allow investigators to conduct scientifically rigorous studies at the point of care.
Practical concerns (eg, high costs and limited generalizability of RCTs, the inability to control for bias in observational studies) may stall CER efforts in athletic training. In short, the aim of the POC-CT is to embed a randomized pragmatic trial into routine care; thus, patients are randomized to minimize potential bias, but the study is conducted at the point of care to limit cost and improve the generalizability of the findings. Furthermore, the POC-CT uses an EMR to replace much of the infrastructure associated with a traditional RCT (eg, research team, patient and clinician reminders) and a Bayesian adaptive feature to help limit the number of patients needed for the study. Together, the EMR and Bayesian adaptive feature can improve the overall feasibility of the study and preserve the typical clinical experiences of the patient and clinician.
The POC-CT includes the basic tenets of practice-based research because studies are conducted at the point of care, in real-life settings, and during routine clinical practice. If implemented effectively, the POC-CT can be seamlessly integrated into daily clinical practice, allowing investigators to establish patient-reported evidence that may be quickly applied to patient care decisions. This design appears to be a promising approach for CER investigations and may help establish a \"learning health care system\" in the sports medicine community.
Journal Article
Practicing outcome-based medical care using pragmatic care trials
The current separation between medical research and care is an obstacle to essential aspects of good medical practice: the verification that care interventions actually deliver the good outcomes they promise, and the use of scientific methods to optimize care under uncertainty. Pragmatic care trials have been designed to address these problems. Care trials are all-inclusive randomized trials integrated into care. Every item of trial design is selected in the best medical interest of participating patients. Care trials can eventually show what constitutes good medical practice based on patient outcomes. In the meantime, care trials give clinicians and patients the scientific methods necessary for optimization of medical care when no one really knows what to do.
We report the progress of 9 randomized care trials that were used to guide the endovascular or surgical management of 1212 patients with acute stroke, intracranial aneurysms, and arteriovenous malformations in a single center in an elective or acute care context. Care trials were used to address long-standing dilemmas regarding rival medical, surgical, or endovascular management options or to offer innovative instead of standard treatments. The trial methodology, by replacing unrepeatable treatment decisions by 1:1 randomized allocation whenever reliable knowledge was not available, had an immediate impact, transforming unverifiable dogmatic medical practice into verifiable outcome-based medical care. We believe the approach is applicable to all medical or surgical domains, but widespread adoption may require the revision of many currently prevalent views regarding the role of research in clinical practice.
Journal Article
Commentary on Point-of-Care Clinical Trials in Sports Medicine Research: Identifying Effective Treatment Interventions Through Real-World Evidence
How is it Generated? A number of definitions have been used to define RWE.2–5 However, these definitions focus on patient information obtained from data collected outside of the traditional research setting to generate evidence about the effectiveness of clinical care and patient outcomes.2,3 Although some sources, such as the POC-CT, are designed to use real-world data to answer a specific research question, other sources may include electronic medical records (EMRs), patient-generated health data (eg, mobile health technologies and wearables), patient registries, and medical claims, among others that are traditionally associated with clinical care.4 These alternative data sources may be used as secondary sources of information for evidence generation. [...]health care is transitioning from a pay-per-service model to a more value-based approach. [...]RWE provides a unique opportunity to answer questions about costs associated with clinical care by using health economics and outcomes research. Data and human participant protection and privacy concerns will still require institutional review board oversight to ensure compliance with the Health Insurance Portability and Accountability Act and part 11 of the Code of Federal Regulations Title 21 (ie, electronic signatures and records).11 International governance regulations, such as the European Union General Data Protection Regulation, may also apply.12 These regulatory, privacy, and data-protection concerns may ultimately affect and determine data availability and accessibility for or research methodologic approaches to RWE in athletic training settings.
Journal Article
Behavioral and Social Sciences at the National Institutes of Health: adoption of research findings in health research and practice as a scientific priority
The National Institutes of Health's Office of Behavioral and Social Sciences Research (OBSSR) recently released its Strategic Plan for 2017 to 2021. This plan highlights three scientific priorities: (1) improve the synergy of basic and applied behavioral and social sciences research, (2) enhance and promote the research infrastructure, methods, and measures needed to support a more cumulative and integrated approach to behavioral and social sciences research, and (3) facilitate the adoption of behavioral and social sciences research findings in health research and in practice. This commentary focuses on the challenges and opportunities to facilitate the adoption of research findings in health research and in practice. In addition to the ongoing NIH support for dissemination and implementation (D&I) research, we must address transformative challenges and opportunities such as better disseminating and implementing D&I research, merging research and practice, adopting more rigorous and diverse methods and measures for both D&I and clinical trials research, evaluating technological-based delivery of interventions, and transitioning from minimally adaptable intervention packages to planned adaptations rooted in behavior change principles. Beyond translation into practice and policy, the OBSSR Strategic Plan also highlights the need for translation of behavioral and social science findings into the broader biomedical research enterprise.
Journal Article
Research methods in clinical psychology
Fully updated to reflect the latest developments, the third edition of Research Methods In Clinical Psychology offers a comprehensive introduction to the various methods, approaches, and strategies for conducting research in the clinical psychology field.
* Represents the most accessible, user-friendly introduction to conducting and evaluating research for clinical psychologists and related professionals
* Ideal for students and practitioners who wish to conduct their own research or gain a better understanding of published research
* Addresses important issues such as philosophical underpinnings of various methodologies, along with socio-political issues that arise in clinical and community settings
* Step-by-step guidance through all phases of a clinical psychology research project—from initial concept and groundwork, through to measurement, design, analysis, and interpretation
* Updates to this edition include new or expanded coverage of such topics as systematic review and literature searching methods, modern psychometric methods, guidance on choosing between different qualitative approaches, and conducting psychological research via the Internet
eBook