Levels of Evidence for Human Studies of Integrative, Alternative, and Complementary Therapies (PDQ®)NCI PDQ Summaries for Patients
A classification system has been developed by the National Cancer Institute's PDQ Adult Treatment Editorial Board to allow the ranking of human cancer treatment studies according to statistical strength of the study design and scientific strength of the treatment outcomes (i.e., endpoints) measured. This classification system has been adapted to allow the ranking of human studies of integrative, alternative, and complementary therapies for cancer. The purpose of classifying studies in this way is to assist readers in evaluating the strength of the evidence associated with particular treatments. However, not all human studies are classified. Only those reporting a therapeutic endpoint(s), such as tumor response, improvement in survival, or measured improvement in quality of life, are considered. In addition, anecdotal reports and individual case reports are not classified because important clinical details are often missing, the evidence from them is generally considered weak, and there is an increased probability that similar results (either positive or negative) will not be obtained with other patients. Furthermore, reports of case series are excluded when the description of clinical findings is so incomplete as to hinder proper assessment and interpretation.
Strength of Study Design
In the classification system, a numeric scale from 1 to 4 is used to indicate the statistical strength of the study design, with 1 assigned to studies having the strongest design and 4 assigned to studies having the weakest design. Further subdivision of some design categories yields finer measures of strength. The various types of study design are described below in descending order of strength:
Strength of Endpoints Measured
The scientific strength of a study's findings is determined by the endpoint(s) measured. In the classification system, a progressive alphabetic scale is used to indicate the scientific strength of endpoints, with the letter A assigned to the strongest endpoint that can be measured and the letter D assigned to the weakest endpoint. Commonly measured endpoints in human cancer treatment studies are listed below in descending order of strength:
Combined Level of Evidence Score
A combined level of evidence score is calculated for each qualifying study—except for Best Case Series—by joining the score for statistical strength of study design with the score for strength of the endpoint(s) measured. Because of their extremely weak study design, Best Case Series are given a score for strength of study design only (i.e., a level of evidence score of 4). The level of evidence scores for the remaining study types range, in decreasing order of strength, from 1iA to 3iiiDiii.
Changes to This Summary (01/15/2019)
The PDQ cancer information summaries are reviewed regularly and updated as new information becomes available. This section describes the latest changes made to this summary as of the date above.
Added text to state that a designation “s” is given to acupuncture studies where the patient is blinded when using a sham control.
This summary is written and maintained by the PDQ Integrative, Alternative, and Complementary Therapies Editorial Board, which is editorially independent of NCI. The summary reflects an independent review of the literature and does not represent a policy statement of NCI or NIH. More information about summary policies and the role of the PDQ Editorial Boards in maintaining the PDQ summaries can be found on the About This PDQ Summary and PDQ® - NCI's Comprehensive Cancer Database pages.
About This PDQ Summary
Purpose of This Summary
This PDQ cancer information summary for health professionals provides comprehensive, peer-reviewed, evidence-based information about the formal ranking system used by the PDQ Editorial Boards to assess evidence supporting the use of specific interventions or approaches. It is intended as a resource to inform and assist clinicians who care for cancer patients. It does not provide formal guidelines or recommendations for making health care decisions.
Reviewers and Updates
This summary is reviewed regularly and updated as necessary by the PDQ Integrative, Alternative, and Complementary Therapies Editorial Board, which is editorially independent of the National Cancer Institute (NCI). The summary reflects an independent review of the literature and does not represent a policy statement of NCI or the National Institutes of Health (NIH).
Board members review recently published articles each month to determine whether an article should:
- be discussed at a meeting,
- be cited with text, or
- replace or update an existing article that is already cited.
Changes to the summaries are made through a consensus process in which Board members evaluate the strength of the evidence in the published articles and determine how the article should be included in the summary.
Any comments or questions about the summary content should be submitted to Cancer.gov through the NCI website's Email Us. Do not contact the individual Board Members with questions or comments about the summaries. Board members will not respond to individual inquiries.
Levels of Evidence
Some of the reference citations in this summary are accompanied by a level-of-evidence designation. These designations are intended to help readers assess the strength of the evidence supporting the use of specific interventions or approaches. The PDQ Integrative, Alternative, and Complementary Therapies Editorial Board uses a formal evidence ranking system in developing its level-of-evidence designations.
Permission to Use This Summary
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The preferred citation for this PDQ summary is:
PDQ® Integrative, Alternative, and Complementary Therapies Editorial Board. PDQ Levels of Evidence for Human Studies of Integrative, Alternative, and Complementary Therapies. Bethesda, MD: National Cancer Institute. Updated <MM/DD/YYYY>. Available at: https://www.cancer.gov/publications/pdq/levels-evidence/cam. Accessed <MM/DD/YYYY>. [PMID: 26389472]
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