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Cover of Best-Case Series for the Use of Immuno-Augmentation Therapy and Naltrexone for the Treatment of Cancer

Best-Case Series for the Use of Immuno-Augmentation Therapy and Naltrexone for the Treatment of Cancer

Evidence Reports/Technology Assessments, No. 78

Principal Investigators: , PhD and , MD. , MD, PhD, EPC Director and , PhD, EPC Director/Statistician. Expert Reviewers: , MD, , MD, , RN, , MD, , MA, , BA, , PhD, , and , BA.

Rockville (MD): Agency for Healthcare Research and Quality (US); .
Report No.: 03-E030ISBN-10: 1-58763-082-6

Structured Abstract

Objectives:

The primary objective of this project was to create a best-case series for two CAM therapies for treating cancer patients: Immuno-Augmentation Therapy (IAT) and low-dose Naltrexone.

Methodology:

The two CAM providers were asked to identify their best cases. The criteria used for a best-case series were based on those established by the National Cancer Institute (NCI). Promising cases were identified and these patients were contacted to obtain permission for us to abstract their file and to be interviewed by telephone. For cases identified as “best cases” based on NCI criteria, all pertinent clinical data (radiologic scans, pathology slides, etc.) were requested from the original institution to confirm the cancer diagnoses and any progression of the cancer. The cases were then reviewed by the NCI Office of Cancer for Complementary and Alternative Medicine.

Main Results:

For both therapies, it was extremely difficult to meet the full documentation requirements of the NCI best-case series criteria. For IAT, nine cases were found that we consider the most complete or appropriate in terms of the NCI criteria for a best-case series. For Naltrexone treatments, only three cases best met the NCI criteria. These cases represent the best that we were able to assemble using the currently accepted best-case method of the NCI.

Conclusions:

Assembling documentary evidence for a best-case series through retrospective case analysis for CAM therapy will seldom meet the full NCI criteria. An alternative approach might be to establish a prospective case series.

Prepared for: Agency for Healthcare Research and Quality, U.S. Department of Health and Human Services.1 Contract No: 290-97-0001. Prepared by: Southern California-RAND Evidence-based Practice Center, Santa Monica, CA.

Suggested citation:

Coulter I, Hardy M, Shekelle P, et al. Best-Case Series for the Use of Immuno-Augmentation Therapy and Naltrexone for the Treatment of Cancer. Evidence Report/Technology Assessment No. 78 (Prepared by Southern California-RAND Evidence-based Practice Center under Contract No 290-97-0001). AHRQ Publication No. 03-E030. Rockville, MD: Agency for Healthcare Research and Quality. April 2003.

This report may be used, in whole or in part, as the basis for development of clinical practice guidelines and other quality enhancement tools, or a basis for reimbursement and coverage policies. AHRQ or U.S. Department of Health and Human Services endorsement of such derivative products may not be stated or implied.

AHRQ is the lead Federal agency charged with supporting research designed to improve the quality of health care, reduce its cost, address patient safety and medical errors, and broaden access to essential services. AHRQ sponsors and conducts research that provides evidence-based information on health care outcomes; quality; and cost, use, and access. The information helps health care decisionmakers—patients and clinicians, health system leaders, and policymakers—make more informed decisions and improve the quality of health care services.

The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services of a particular drug, device, test, treatment, or other clinical service.

Bookshelf ID: NBK36952
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