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Pharmacoepidemiology and Drug Safety Dec 2016Because of an increasing demand for quality comparative effectiveness research (CER), methods guidance documents have been published, such as those from the Agency for... (Review)
Review
PURPOSE
Because of an increasing demand for quality comparative effectiveness research (CER), methods guidance documents have been published, such as those from the Agency for Healthcare Research and Quality (AHRQ) and the Patient-Centered Outcomes Research Institute (PCORI). Our objective was to identify CER methods guidance documents and compare them to produce a summary of important recommendations which could serve as a consensus of CER method recommendations.
METHODS
We conducted a systematic literature review to identify CER methods guidance documents published through 2014. Identified documents were analyzed for methods guidance recommendations. Individual recommendations were categorized to determine the degree of overlap.
RESULTS
We identified nine methods guidance documents, which contained a total of 312 recommendations, 97% of which were present in two or more documents. All nine documents recommended transparency and adaptation for relevant stakeholders in the interpretation and dissemination of results. Other frequently shared CER methods recommendations included: study design and operational definitions should be developed a priori and allow for replication (n = 8 documents); focus on areas with gaps in current clinical knowledge that are relevant to decision-makers (n = 7); validity of measures, instruments, and data should be assessed and discussed (n = 7); outcomes, including benefits and harms, should be clinically meaningful, and objectively measured (n = 7). Assessment for and strategies to minimize bias (n = 6 documents), confounding (n = 6), and heterogeneity (n = 4) were also commonly shared recommendations between documents.
CONCLUSIONS
We offer a field-consensus guide based on nine CER methods guidance documents that will aid researchers in designing CER studies and applying CER methods. Copyright © 2016 John Wiley & Sons, Ltd.
Topics: Bias; Comparative Effectiveness Research; Confounding Factors, Epidemiologic; Consensus; Humans; Outcome Assessment, Health Care; Research Design
PubMed: 27365094
DOI: 10.1002/pds.4051 -
Journal of Pain & Palliative Care... Sep 2014Outcomes research studies use clinical and administrative data generated in the course of patient care or from patient surveys to examine the effectiveness of... (Review)
Review
Outcomes research studies use clinical and administrative data generated in the course of patient care or from patient surveys to examine the effectiveness of treatments. Health care providers need to understand the limitations and strengths of the real-world data sources used in outcomes studies to meaningfully use the results. This paper describes five types of databases commonly used in the United States for outcomes research studies, discusses their strengths and limitations, and provides examples of each within the context of pain treatment. The databases specifically discussed are generated from (1) electronic medical records, which are created from patient-provider interactions; (2) administrative claims, which are generated from providers' and patients' transactions with payers; (3) integrated health systems, which are generated by systems that provide both clinical care and insurance benefits and typically represent a combination of electronic medical record and claims data; (4) national surveys, which provide patient-reported responses about their health and behaviors; and (5) patient registries, which are developed to track patients with a given disease or exposure over time for specified purposes, such as population management, safety monitoring, or research.
Topics: Data Collection; Databases, Factual; Delivery of Health Care, Integrated; Electronic Health Records; Humans; Insurance Claim Reporting; Outcome Assessment, Health Care; Pain; Pain Management
PubMed: 25136897
DOI: 10.3109/15360288.2014.941131 -
The Journal of Allergy and Clinical... Sep 2023
Topics: Humans; Outcome Assessment, Health Care
PubMed: 37684077
DOI: 10.1016/j.jaip.2023.05.018 -
Academic Emergency Medicine : Official... Dec 2018The evidence supporting best practices when treating children in the prehospital setting or even the effect emergency medical services (EMS) has on patient outcomes is...
The evidence supporting best practices when treating children in the prehospital setting or even the effect emergency medical services (EMS) has on patient outcomes is limited. Standardizing the critical outcomes for EMS research will allow for focused and comparable effort among the small but growing group of pediatric EMS investigators on specific topics. Standardized outcomes will also provide the opportunity to collectively advance the science of EMS for children and demonstrate the effect of EMS on patient outcomes. This article describes a consensus process among stakeholders in the pediatric emergency medicine and EMS community that identified the critical outcomes for EMS care in five clinical areas (traumatic brain injury, general injury, respiratory disease/failure, sepsis, and seizures). These areas were selected based on both their known public health importance and their commonality in EMS encounters. Key research outcomes identified by participating stakeholders using a modified nominal group technique for consensus building, which included small group brainstorming and independent voting for ranking outcomes that were feasible and/or important for the field.
Topics: Child; Health Services Research; Humans; Outcome Assessment, Health Care; Pediatric Emergency Medicine
PubMed: 30312993
DOI: 10.1111/acem.13637 -
Academic Radiology Sep 2014The creation of the Patient-Centered Outcomes Research Trust Fund and the Patient-Centered Outcomes Research Institute (PCORI) through the Patient Protection and... (Review)
Review
The creation of the Patient-Centered Outcomes Research Trust Fund and the Patient-Centered Outcomes Research Institute (PCORI) through the Patient Protection and Affordable Care Act of 2010 presents new opportunities for funding patient-centered comparative effectiveness research (CER) in radiology. We provide an overview of the evolution of federal funding and priorities for CER with a focus on radiology-related priority topics over the last two decades, and discuss the funding processes and methodological standards outlined by PCORI. We introduce key paradigm shifts in research methodology that will be required on the part of radiology health services researchers to obtain competitive federal grant funding in patient-centered outcomes research. These paradigm shifts include direct engagement of patients and other stakeholders at every stage of the research process, from initial conception to dissemination of results. We will also discuss the increasing use of mixed methods and novel trial designs. One of these trial designs, the pragmatic trial, has the potential to be readily applied to evaluating the effectiveness of diagnostic imaging procedures and imaging-based interventions among diverse patient populations in real-world settings.
Topics: Comparative Effectiveness Research; Diagnostic Imaging; Health Services Research; Humans; Outcome Assessment, Health Care; Patient Outcome Assessment; Patient Protection and Affordable Care Act; Patient-Centered Care; Radiology; Research Design; United States
PubMed: 24998691
DOI: 10.1016/j.acra.2014.01.027 -
Journal of Neurosurgical Anesthesiology Jan 2023Neurodevelopmental outcomes research in children following extracorporeal membrane oxygenationis a complex and evolving field. From systematic reviews to multi-center... (Review)
Review
Neurodevelopmental outcomes research in children following extracorporeal membrane oxygenationis a complex and evolving field. From systematic reviews to multi-center prospective cohort studies, a variety of research endeavors in this domain have already been conducted. Recent attention has redirected the focus on biomarkers and imaging studies to help better understand the neurological, developmental, and behavioral effects of extracorporeal membrane oxygenation on surviving children. This review provides an overview of major research in the field, ongoing and future studies, and a summary of lessons learned from these efforts.
Topics: Child; Humans; Infant; Prospective Studies; Extracorporeal Membrane Oxygenation; Outcome Assessment, Health Care; Respiratory Insufficiency; Biomarkers
PubMed: 36745174
DOI: 10.1097/ANA.0000000000000878 -
Annals of Plastic Surgery Apr 2016The use of "Big Data" in plastic surgery outcomes research has increased dramatically in the last 5 years. This article addresses some of the benefits and limitations of... (Review)
Review
BACKGROUND
The use of "Big Data" in plastic surgery outcomes research has increased dramatically in the last 5 years. This article addresses some of the benefits and limitations of such research.
METHODS
This is a narrative review of large database studies in plastic surgery.
RESULTS
There are several benefits to database research as compared with traditional forms of research, such as randomized controlled studies and cohort studies. These include the ease in patient recruitment, reduction in selection bias, and increased generalizability. As such, the types of outcomes research that are particularly suited for database studies include determination of geographic variations in practice, volume outcome analysis, evaluation of how sociodemographic factors affect access to health care, and trend analyses over time. The limitations of database research include data which are limited only to what was captured in the database, high power which can cause clinically insignificant differences to achieve statistical significance, and fishing which can lead to increased type I errors. The National Surgical Quality Improvement Project is an important general surgery database that may be useful for plastic surgeons because it is validated and has a large number of patients after over a decade of collecting data. The Tracking Operations and Outcomes for Plastic Surgeons Program is a newer database specific to plastic surgery.
CONCLUSIONS
Databases are a powerful tool for plastic surgery outcomes research. It is critically important to understand their benefits and limitations when designing research projects or interpreting studies whose data have been drawn from them. For plastic surgeons, National Surgical Quality Improvement Project has a greater number of publications, but Tracking Operations and Outcomes for Plastic Surgeons Program is the most applicable database for plastic surgery research.
Topics: Databases, Factual; Humans; Outcome Assessment, Health Care; Plastic Surgery Procedures; Registries; Research Design
PubMed: 26849283
DOI: 10.1097/SAP.0000000000000750 -
The Canadian Journal of Cardiology May 2019New knowledge about male-female differences in pathophysiology, diagnosis, and treatment is shifting the practice of medicine from a one-size-fits all approach to a more... (Review)
Review
New knowledge about male-female differences in pathophysiology, diagnosis, and treatment is shifting the practice of medicine from a one-size-fits all approach to a more individualized process that considers sex-specific interventions at the point of care. In this article, we review how clinical practice guideline committees can incorporate a structured framework to determine whether sex-specific assessments of the quality of the evidence or the particular recommendations should be made. The process can be operationalized by societies who author clinical practice guidelines by developing formal policies to approach biological sex in a systematic way, and by ensuring that writing committees include an individual who will champion the formal appraisal of the literature for associations between sex and the outcomes of interest. Ongoing challenges are discussed, and solutions are provided for how to disaggregate the evidence, how to assess bias, how to improve search strategies, and what to do when the data are insufficient to make sex-specific recommendations. Application of sex-specific recommendations will involve routinely asking whether the presentation, diagnostic workup, or management might change for each patient if they were the opposite sex.
Topics: Cardiovascular Diseases; Humans; Outcome Assessment, Health Care; Practice Guidelines as Topic; Sex Factors
PubMed: 30910247
DOI: 10.1016/j.cjca.2018.11.011 -
Wiener Klinische Wochenschrift Nov 2019The aims of this article are to provide an overview and discuss current concepts and future trends in outcomes research in non-specific low back pain, specifically... (Review)
Review
OBJECTIVE
The aims of this article are to provide an overview and discuss current concepts and future trends in outcomes research in non-specific low back pain, specifically considering the perspective of patients, patient-reported outcomes and outcome measures as well as to facilitate knowledge transfer into clinical practice.
REVIEW STRATEGY
The breadth of this work and the required brevity of this article were not amenable to a formal approach, such as a systematic literature review or a formal scoping review. Literature sources were identified through medical databases but different sources of information and of various methodologies were also included. Furthermore, outcomes meaningful for patients and examples of outcome measures that are applicable in clinical practice were extracted. Areas for future research were identified and discussed.
RESULTS
Patient-reported outcomes and outcome measures are essential in patient-centered care. The assessment of the patients' perspective is important to ensure motivation, active involvement, self-management and adherence, especially in non-pharmacological interventions for low back pain. To facilitate the use of outcome measurements for low back pain in clinical practice, future studies should focus on a clinically feasible index, which includes patient-reported as well as clinician-reported or performance-based variables. Relationships between different types of outcomes and outcome measures as well as resource and outcome-based healthcare constitute important topics for future research. New digital technologies can support continuous outcome measurement and might enable new patient-driven models of care.
CONCLUSION
Active patient involvement is an essential part of non-pharmacological treatment in low back pain and needs to be considered in terms of outcomes and outcome measurement.
Topics: Humans; Low Back Pain; Outcome Assessment, Health Care; Patient Participation; Patient Satisfaction; Patient-Centered Care; Treatment Outcome
PubMed: 31236662
DOI: 10.1007/s00508-019-1523-4 -
Health Services Research Apr 2017To learn how minority and underserved communities would set priorities for patient-centered outcomes research (PCOR).
OBJECTIVE
To learn how minority and underserved communities would set priorities for patient-centered outcomes research (PCOR).
DATA SOURCES
Sixteen groups (n = 183) from minority and underserved communities in two states deliberated about PCOR priorities using the simulation exercise CHoosing All Together (CHAT). Most participants were minority, one-third reported income <$10,000, and one-fourth reported fair/poor health.
DESIGN
Academic-community partnerships adapted CHAT for PCOR priority setting using existing research agendas and interviews with community leaders, clinicians, and key informants.
DATA COLLECTION
Tablet-based CHAT collected demographic information, individual priorities before and after group deliberation, and groups' priorities.
PRINCIPAL FINDINGS
Individuals and groups prioritized research on Quality of Life, Patient-Doctor, Access, Special Needs, and (by total resources spent) Compare Approaches. Those with less than a high school education were less likely to prioritize New Approaches, Patient-Doctor, Quality of Life, and Families/Caregivers. Blacks were less likely to prioritize research on Causes of Disease, New Approaches, and Compare Approaches than whites. Compare Approaches, Special Needs, Access, and Families/Caregivers were significantly more likely to be selected by individuals after compared to before deliberation.
CONCLUSIONS
Members of underserved communities, in informed deliberations, prioritized research on Quality of Life, Patient-Doctor, Special Needs, Access, and Compare Approaches.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Attitude to Health; Female; Focus Groups; Health Services Accessibility; Health Services Needs and Demand; Health Services Research; Humans; Interviews as Topic; Male; Middle Aged; Minority Groups; Outcome Assessment, Health Care; Patient-Centered Care; Physician-Patient Relations; Quality of Life; Research; Vulnerable Populations; Young Adult
PubMed: 27206519
DOI: 10.1111/1475-6773.12505