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Anesthesia and Analgesia Aug 2017One of the first steps in designing and conducting a research study is identifying the primary and any secondary study outcomes. In an experimental, quasi-experimental,...
One of the first steps in designing and conducting a research study is identifying the primary and any secondary study outcomes. In an experimental, quasi-experimental, or analytic observational research study, the primary study outcomes arise from and align directly with the primary study aim or objective. Likewise, any secondary study outcomes arise from and directly align with any secondary study aim or objective. One designated primary study outcome then forms the basis for and is incorporated literally into the stated hypothesis. In a Methods section, authors clearly state and define each primary and any secondary study outcome variable. In the same Methods section, authors clearly describe how all primary and any secondary study outcome variables were measured. Enough detail is provided so that a clinician, statistician, or informatician can know exactly what is being measured and that other investigators could duplicate the measurements in their research venue. The authors provide published substantiation (preferably) or other documented evidence of the validity and reliability of any applied measurement instrument, tool, or scale. A common pitfall-and often fatal study design flaw-is the application of a newly created ("home-grown") or ad hoc modification of an existing measurement instrument, tool, or scale-without any supporting evidence of its validity and reliability. An optimal primary outcome is the one for which there is the most existing or plausible evidence of being associated with the exposure of interest or intervention. Including too many primary outcomes can (a) lead to an unfocused research question and study and (b) present problems with interpretation if the treatment effect differed across the outcomes. Inclusion of secondary variables in the study design and the resulting manuscript needs to be justified. Secondary outcomes are particularly helpful if they lend supporting evidence for the primary endpoint. A composite endpoint is an endpoint consisting of several outcome variables that are typically correlated with each. In designing a study, researchers limit components of a composite endpoint to variables on which the intervention of interest would most plausibly have an effect, and optimally with preliminary evidence of an effect. Ideally, components of a strong composite endpoint have similar treatment effect, frequency, and severity-with the most important being similar severity.
Topics: Clinical Trials as Topic; Humans; Outcome Assessment, Health Care; Reproducibility of Results; Research Design; Statistics as Topic; Treatment Outcome
PubMed: 28682958
DOI: 10.1213/ANE.0000000000002224 -
Current Opinion in Anaesthesiology Dec 2016Measuring clinically relevant and patient-centered perioperative outcomes provides the knowledge that enables clinicians to optimize their practice and guide shared... (Review)
Review
PURPOSE OF REVIEW
Measuring clinically relevant and patient-centered perioperative outcomes provides the knowledge that enables clinicians to optimize their practice and guide shared decision-making, researchers to set a future agenda and policymakers to prioritize healthcare spending.
RECENT FINDINGS
A large international collaboration is currently working to define a set of core outcomes for use in perioperative medicine research. Standardizing which outcomes are measured and how they are defined will help ensure that perioperative research output is meaningful and practice changing. The ability to pool nonheterogeneous data from multiple clinical trials will also improve ability of research to provide definitive answers and improve the cost-effectiveness of research spending.
SUMMARY
Future clinical trials in perioperative medicine should utilize clearly defined, validated and standardized patient-centered outcome measures.
Topics: Clinical Trials as Topic; Decision Making; Humans; Outcome Assessment, Health Care; Patient-Centered Care; Perioperative Care; Practice Guidelines as Topic; Quality of Life
PubMed: 27466976
DOI: 10.1097/ACO.0000000000000383 -
Plastic and Reconstructive Surgery Oct 2021
Topics: History, 20th Century; History, 21st Century; Humans; Outcome Assessment, Health Care; Publishing; Surgery, Plastic
PubMed: 34550951
DOI: 10.1097/PRS.0000000000008347 -
The Patient Jul 2021
Topics: Economics, Medical; Humans; Outcome Assessment, Health Care; Public Health
PubMed: 33728553
DOI: 10.1007/s40271-021-00505-3 -
Archives of Disease in Childhood.... Jun 2018
Topics: Clinical Trials as Topic; Humans; Outcome Assessment, Health Care; Pediatrics; Practice Guidelines as Topic; Research Design
PubMed: 28667046
DOI: 10.1136/archdischild-2016-312117 -
Therapeutic Innovation & Regulatory... May 2018To identify, evaluate, and characterize the variety, quality, and intent of the health economics and outcomes research studies being conducted in SAARC (South Asian... (Review)
Review
OBJECTIVE
To identify, evaluate, and characterize the variety, quality, and intent of the health economics and outcomes research studies being conducted in SAARC (South Asian Association for Regional Cooperation) nations.
METHODS
Studies published in English language between 1990 and 2015 were retrieved from Medline databases using relevant search strategies. Studies were independently reviewed as per Cochrane methodology and information on the type of research and outcomes were extracted. Quality of reporting was assessed.
RESULTS
Of the 2638 studies screened from eight SAARC nations, a total of 179 were included for review (India = 140; Bangladesh = 12; Sri Lanka = 8; Pakistan = 7; Afghanistan = 5; Nepal = 4; Bhutan = 2; Maldives = 1). The broad study categories were cost-effectiveness analyses (CEAs = 76 studies), cost analyses (35 studies), and burden of illness (BOI=26 studies). The outcomes evaluated were direct costs, indirect costs, and incremental cost-effectiveness ratio (ICER), quality-adjusted life-years (QALYs), and disability-adjusted life-years (DALYs). Cost of medicines, consultation and hospital charges, and monitoring costs were assessed as direct medical costs along with non-direct medical costs such as travel and food for patients and caregivers. The components of indirect costs were loss of income of patients and caregivers and loss of productivity. Quality of life (QoL) was assessed in 48 studies. The most commonly used instrument for assessing QoL was the WHO-Quality of Life BREF (WHOQOL-BREF) questionnaire (76%). The Quality of Health Economic Studies (QHES) score was used for quality assessment of full economic studies (44 studies). The mean QHES score was 43.76.
CONCLUSION
This review identifies various patterns of health economic studies in eight SAARC nations. The quality of economic evaluation studies for health care in India, Bangladesh, Sri Lanka, Pakistan, Afghanistan, Nepal, Bhutan, and Maldives needs improvement. There is a need to generate the capacity of researchers to undertake quality economic evaluations as well as an orientation of the policy makers so that there is a demand for such studies as well as a scope for its use in policy making.
Topics: Asia; Cost of Illness; Cost-Benefit Analysis; Economics, Medical; Health Expenditures; Humans; Outcome Assessment, Health Care; Program Evaluation; Quality of Life; Quality-Adjusted Life Years; Research Design
PubMed: 29714540
DOI: 10.1177/2168479017731583 -
JAMA Neurology May 2019Neurocritical care has grown into an organized specialty that may have consequences for patient care, outcomes, research, and neurointensive care (neuroICU) technology. (Review)
Review
IMPORTANCE
Neurocritical care has grown into an organized specialty that may have consequences for patient care, outcomes, research, and neurointensive care (neuroICU) technology.
OBSERVATIONS
Neurocritical care improves care and outcomes of the patients who are neurocritically ill, and neuroICUs positively affect the financial state of health care systems. The development of neurocritical care as a recognized subspecialty has fostered multidisciplinary research, neuromonitoring, and neurocritical care information technology, with advances and innovations in practice and progress.
CONCLUSIONS AND RELEVANCE
Neurocritical care has become an important part of health systems and an established subspecialty of neurology. Understanding its structure, scope of practice, consequences for care, and research are important.
Topics: Biomedical Research; Biomedical Technology; Cerebrovascular Circulation; Critical Care; Critical Care Outcomes; Electroencephalography; Humans; Intensive Care Units; Intracranial Pressure; Microdialysis; Monitoring, Physiologic; Neurology; Outcome Assessment, Health Care; Patient Care Team; Quality of Health Care
PubMed: 30667464
DOI: 10.1001/jamaneurol.2018.4407 -
Seminars in Perinatology Jun 2019Outcomes research on obstetric venous thromboembolism (VTE) involves a number of major challenges. While obstetric VTE, including deep vein thrombosis and pulmonary... (Review)
Review
Outcomes research on obstetric venous thromboembolism (VTE) involves a number of major challenges. While obstetric VTE, including deep vein thrombosis and pulmonary embolism, is relatively common on a population basis, diagnoses during pregnancy are relatively rare in comparison to high-risk scenarios such as orthopedic surgery. This review characterizes outcomes research on obstetric VTE with a focus on strengths, limitations, and appropriate inferences from existing research. It is divided into four sections. First, evidence regarding validity of diagnosis codes for VTE in administrative data is reviewed. Second, limitations of both clinical research and administrative-data study models are analyzed. Third, examples of high-quality obstetric VTE research from the literature and opportunities for improved research in the future are reviewed. Fourth, future directions for research are explored.
Topics: Biomedical Research; Female; Humans; Obstetrics; Outcome Assessment, Health Care; Pregnancy; Pregnancy Complications, Cardiovascular; Reproducibility of Results; Risk Factors; Venous Thromboembolism
PubMed: 30935756
DOI: 10.1053/j.semperi.2019.03.003 -
Journal of Surgical Oncology Oct 2014Outcomes research uses diverse inputs to examine innovative end results aimed to deliver quality patient care. Yet defining "outcomes research" remains a challenge, and... (Review)
Review
Outcomes research uses diverse inputs to examine innovative end results aimed to deliver quality patient care. Yet defining "outcomes research" remains a challenge, and its interpretation is often nuanced. In this review, we discuss the definition of outcomes research in the context of its historical evolution along with the rise of other similar types of research. We then discuss key considerations in interpreting the results of outcomes analysis.
Topics: Comparative Effectiveness Research; Databases, Factual; Health Services Research; History, 20th Century; History, 21st Century; Outcome Assessment, Health Care; Risk
PubMed: 24996156
DOI: 10.1002/jso.23710 -
Neurosurgery Sep 2018Quality improvement, value-based care delivery, and personalized patient care depend on robust clinical, financial, and demographic data streams of neurosurgical... (Review)
Review
BACKGROUND
Quality improvement, value-based care delivery, and personalized patient care depend on robust clinical, financial, and demographic data streams of neurosurgical outcomes. The neurosurgical literature lacks a comprehensive review of large national databases.
OBJECTIVE
To assess the strengths and limitations of various resources for outcomes research in neurosurgery.
METHODS
A review of the literature was conducted to identify surgical outcomes studies using national data sets. The databases were assessed for the availability of patient demographics and clinical variables, longitudinal follow-up of patients, strengths, and limitations.
RESULTS
The number of unique patients contained within each data set ranged from thousands (Quality Outcomes Database [QOD]) to hundreds of millions (MarketScan). Databases with both clinical and financial data included PearlDiver, Premier Healthcare Database, Vizient Clinical Data Base and Resource Manager, and the National Inpatient Sample. Outcomes collected by databases included patient-reported outcomes (QOD); 30-day morbidity, readmissions, and reoperations (National Surgical Quality Improvement Program); and disease incidence and disease-specific survival (Surveillance, Epidemiology, and End Results-Medicare). The strengths of large databases included large numbers of rare pathologies and multi-institutional nationally representative sampling; the limitations of these databases included variable data veracity, variable data completeness, and missing disease-specific variables.
CONCLUSION
The improvement of existing large national databases and the establishment of new registries will be crucial to the future of neurosurgical outcomes research.
Topics: Databases, Factual; Female; Humans; Neurosurgery; Outcome Assessment, Health Care; Registries; United States
PubMed: 28950367
DOI: 10.1093/neuros/nyx408