CLSI GP45
Studies to Evaluate Patient Outcomes
This guideline outlines the key issues in planning outcomes research, such as resources needed, formulating a research question, validity and sources of error, feasibility, and ethical considerations. It also addresses the design and implementation of a patient outcomes research plan, covering study design, subjects, measurements, interventions and analysis. The guidance summarizes recommendations for reporting patient outcomes research and includes definitions, references, and resources for those interested in planning, conducting, and using patient outcomes research.
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{{FormatPrice(nonMemberPrice)}} List PriceCLSI document GP45-A—Studies to Evaluate Patient Outcomes; Approved Guideline provides an overview of patient outcomes studies and health services research to assist healthcare providers, managers of healthcare services, and others in planning, conducting, and reporting patient outcomes research. This guideline describes the essential issues in planning outcomes research, including resources needed, formulating a research question, validity and sources of error, feasibility, and ethical issues; addresses the design and implementation of a patient outcomes research plan, including study design, study subjects, measurements, interventions, and analysis; summarizes recommendations for reporting patient outcomes research; and includes definitions, references, and resources for those interested in planning, conducting, and using patient outcomes research.
This guideline can be applied to studies to evaluate patient outcomes by any service in a healthcare organization or manufacturer of a healthcare product. It includes essential elements to consider in either conducting studies, or evaluating previously conducted studies. The principles described are universal and can be used to make decisions about the most appropriate structure and processes to use for delivery of healthcare services. The document has been developed through the NCCLS consensus process and describes general criteria for conducting studies of patient outcomes. It is not intended to be a primer or manual for conducting research. There are several excellent books available for readers interested in more specific information about how to conduct a patient outcomes study, including information on qualitative and quantitative research methods (see the Additional References section).
The focus of this guideline is on primary studies in patient outcomes research. These include observational studies (surveys or cross-sectional studies, case-control studies, and cohort studies) and interventional studies (randomized controlled trials and nonrandomized studies).
The role of systematic overviews, meta-analyses, decision analyses, cost-effectiveness analyses, and simulations is described briefly.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.
This document is available in electronic format only.
CLSI document GP45-A—Studies to Evaluate Patient Outcomes; Approved Guideline provides an overview of patient outcomes studies and health services research to assist healthcare providers, managers of healthcare services, and others in planning, conducting, and reporting patient outcomes research. This guideline describes the essential issues in planning outcomes research, including resources needed, formulating a research question, validity and sources of error, feasibility, and ethical issues; addresses the design and implementation of a patient outcomes research plan, including study design, study subjects, measurements, interventions, and analysis; summarizes recommendations for reporting patient outcomes research; and includes definitions, references, and resources for those interested in planning, conducting, and using patient outcomes research.
This guideline can be applied to studies to evaluate patient outcomes by any service in a healthcare organization or manufacturer of a healthcare product. It includes essential elements to consider in either conducting studies, or evaluating previously conducted studies. The principles described are universal and can be used to make decisions about the most appropriate structure and processes to use for delivery of healthcare services. The document has been developed through the NCCLS consensus process and describes general criteria for conducting studies of patient outcomes. It is not intended to be a primer or manual for conducting research. There are several excellent books available for readers interested in more specific information about how to conduct a patient outcomes study, including information on qualitative and quantitative research methods (see the Additional References section).
The focus of this guideline is on primary studies in patient outcomes research. These include observational studies (surveys or cross-sectional studies, case-control studies, and cohort studies) and interventional studies (randomized controlled trials and nonrandomized studies).
The role of systematic overviews, meta-analyses, decision analyses, cost-effectiveness analyses, and simulations is described briefly.
This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid and because of its value to the laboratory community, it is being retained in CLSI’s library.
This document is available in electronic format only.