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External and Implantable Infusion Pumps

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Title: External and Implantable Infusion Pumps.

Agency: Agency for Health Care Policy and Research/Center for Health Care Technology (Formerly, the Office of Health Technology Assessment).

Contact: Ann A. Graham, Senior Health Policy Analyst; Thomas V. Holohan, M.D., Director, CHCT.

Status: Technology Review: Published, 1994.

Language: English.

Primary Objective: To evaluate the safety and effectiveness of intrahepatic chemotherapeutic agents, intraspinal morphine for intractable malignant and nonmalignant pain, and intrathecal baclofen for chronic, intractable spasticity used with an external infusion pump or implantable infusion pump, access system, and temporary or permanent indwelling catheter.

Methods Used: Online search (Paperchase) of human studies published in English from 1984 to 1992, using the following MESH terms: cytotoxic agents, drug therapy, pain/nonmalignant, pain/ chronic, antispasmodic drug therapy, infusion pumps/implantable.

Data Identification: Published journal articles, relevant NLM textbooks.

Study Selection: Chemotherapy: 4 RCTs and 1 case series. These studies were chosen based on strengths of external validity of study design (randomization, patient selection criteria, etc.). Morphine: 9 case series (812) patients) chosen based on availability of evidence, less so on methodology. Baclofen: 129 patients results reported in 5 case series of methodologically suspect design.

Data Extraction: The guideline used was quality of evidence. Report results were judged to be more reliable when the methodology of the clinical case series was defensible. We placed confidence in clinical studies according to the design of the study (ranked from most reliable): randomized, controlled, clinical trial; controlled case series, case reports, unsupported anecdotal evidence (including expert opinion).

Key Results/Findings: Chemo: methodologically defensible designs, ineffectiveness of the drugs themselves (independent of the function of the implantable pumps), comparatively few enrollees, given the incidence of colorectal cancer. Morphine: methodologically devoid of scientific rigor in clinical studies, tolerance over time, devices work well. Baclofen: methodologically devoid of scientific rigor (no patient selection criteria, no interim evaluation of underlying pathology), tolerance over time, devices work well.

Conclusions/Options/Recommendations: Chemotherapy: no increase in survival in the implanted groups. Recommend its use in the investigational arena only. Morphine and Baclofen: a stepwise treatment plan, including evaluation of prior responses to noninvasive pain and spasticity control methods. Life expectancy and cost need to be considered. A trial of transcutaneous drug should be undertaken before implantation of a permanent system.

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