Technology Assessment Reports
Acupuncture for chronic osteoarthritis pain, headache and low back pain
Acupuncture for treatment of chemical dependency
Assisted Reproductive Technologies
Botulinum toxin therapy Cardiac rehabilitation
Cardiac Rehabilitation
Cochlear implants
Computed Tomography for the Diagnosis of Pulmonary Embolism
Densitometry as a screening tool for osteoporosis in women
Dorsal rhizotomy for spasticity
Electrical stimulation for non-union of a fracture
EEG during carotid artery surgery
Electron-beam computed tomography for coronary artery disease
Excimer laser use in ophthalmology
Genetic screening for breast cancer
High-dose chemotherapy with autologous stem cell support for the treatment of breast cancer
High-dose chemotherapy with hematopoietic stem cell transplantation for treatment of multiple myeloma
High-frequency chest compression devices for cystic fibrosis
Home uterine activity monitoring
Interferon beta-1B for multiple sclerosis
Intrathecal baclofen infusion for controlling spasticity and spasms
Intravenous immune gamma globulin (IVIG) for treatment of neurological conditions
Lung reduction surgery
Lung transplants
Magnetic resonance angiography
Minimally Invasive Direct Vision Coronary Artery Bypass Grafting (MIDCABG)
Morbid obesity surgery
Oral devices for the treatment of sleep apnea syndrome
Pancreas transplants
PET and SPECT scans for the evaluation of epileptic patients
Photodynamic Therapy for Head and Neck, Tracheobronchial, and Esophageal Cancer
Prenatal ultrasound as a screening test
Prostate specific antigen (PSA) as a screening test for prostate cancer
Pulmonary rehabilitation for chronic obstructive pulmonary disease
Screening for the Factor V R506Q (Leiden) Mutation Prior to Oral Contraceptive Prescription
Screening tests
Small bowel transplantation
Stereotactically directed fine-needle aspiration biopsy (FNAB) and core biopsy of nonpalpable breast lesions
Stereotactic radiosurgery for brain lesions
Tissue-type plasminogen activator for acute ischemic stroke
Transjugular intrahepatic porto-systemic shunts
Tympanic ear thermometers
Cochlear Implants - Order # T1
Adopted: 05/13/93
The ICSI Technology Assessment Committee finds that, for the properly selected individual, cochlear implants can give a substantial lifelong benefit where there is no alternative treatment available today.
High-Dose Chemotherapy with Autologous Stem Cell Support for the Treatment of Breast Cancer - Order # T2
Adopted: 06/23/93
Updated: 07/10/96
The ICSI Technology Assessment Committee finds that high-dose chemotherapy with autologous stem cell support is an investigational procedure regarding its safety and effectiveness for the treatment of breast cancer.
Excimer Laser Use in Ophthalmology - Order # T3
Adopted: 06/23/93
Reviewed: 06/11/96
The Excimer laser appears to be a safe and effective treatment for therapeutic ophthalmologic indications, such as treatment of corneal scars and degenerations, and recurrent epithelial erosion. While it seems to be helpful in treating refractive errors as well, glasses and contact lenses are less risky and superior for most refractive errors.
Pancreas Transplants - Order # T4
Adopted: 06/23/93
Reviewed: 03/16/96
The ICSI Technology Assessment Committee finds pancreatic transplantation to be an investigational treatment. Simultaneous pancreas-kidney transplantation may be beneficial for carefully selected patients, as an alternative to kidney transplantation alone. Any benefits from insulin independence, however, must be weighed against the side effects of immunosuppression and the risk of acute and chronic rejection.
High-Frequency Chest Compression Devices for Cystic Fibrosis - Order # T5
Adopted: 06/23/93
Updated: 03/06/96
The ICSI Technology Assessment Committee finds that high-frequency chest compression devices are safe and effective for use in cystic fibrosis therapy, but have no proven advantage over standard chest physical therapy.
Intravenous Immune Gamma Globulin (IVIG) for Treatment of Neurological Conditions - Order # T6
Adopted: 08/04/93
Updated: 02/18/98
The ICSI Technology Assessment Committee finds that IVIG is a safe treatment except in patients with heart disease, renal insufficiency, or bed-bound status. Long-term risks are not known and the required dosages for long-term IVIG use have not been determined. For the potential uses addressed in this report:
Lung Transplants - Order # T7
Adopted: 09/08/93
The ICSI Technology Assessment Committee finds that lung transplantation, although considered investigational, may be beneficial for carefully selected patients with end-stage pulmonary disease.
Prostate Specific Antigen as a Screening Test for Prostate Cancer - Order # T8
Adopted: 09/08/93
Reviewed: 08/01/96
The ICSI Technology Assessment Committee finds that while PSA has been shown to detect some prostate cancer, it is not established that early detection of prostate cancer results in reduced morbidity or mortality from the disease. Therefore, the value of PSA as a screening test is unproven.
Screening Tests - Order # T9
Adopted: 10/13/93
Reviewed: 10/01/96
Screening has benefit only if both of the following two conditions are met:
  1. Screening tests must be able to detect the target condition earlier than without screening and with sufficient accuracy to avoid producing a large number of false-positive and false-negative results.
  2. Persons with disease who are detected early should have a better clinical outcome than those who are detected without screening. Treatment of the disease after detection by the screening process must result in decreased morbidity and mortality for the patient.
PET and SPECT Scans for the Evaluation of Epileptic Patients - Order # T10
Adopted: 01/12/94
Reviewed: 02/10/97
The ICSI Technology Assessment Committee finds that interictal PET and ictal or immediately post-ictal 3-headed SPECT scans are safe and effective as supplementary tools to established methodologies for locating epileptic foci in patients with intractable epilepsy. While they are not effective as stand-alone diagnostic mechanisms, they may be helpful when other non-invasive tests cannot accurately localize the epileptiform focus or electrographic seizure onset.
Interferon Beta-1B for Multiple Sclerosis - Order # T11
Adopted: 01/12/94
Reviewed: 02/17/97
The ICSI Technology Assessment Committee finds that Interferon b-1b (IFNB) given by injection every other day is safe and efficacious for treatment of ambulatory patients with mild to moderate relapsing-remitting multiple sclerosis. It is unknown whether IFNB is effective in a community setting (versus efficacious in the clinical trial setting), or for how long patients should be treated with IFNB.
Cardiac Rehabilitation - Order # T12
Adopted: 02/23/94
The ICSI Technology Assessment Committee finds outpatient cardiac rehabilitation (Phase II, III, and IV) to be safe and effective for selected patients in stable condition with a diagnosis of acute myocardial infarction, coronary bypass surgery, or cardiac valve surgery; however, most patients free from serious complications may achieve the same results without a supervised program. The Committee did not evaluate Phase I cardiac rehabilitation, as it is seen as part of the hospital care for these patients.
Oral Devices for the Treatment of Sleep Apnea Syndrome - Order # T13
Adopted: 04/13/94
Reviewed: 02/06/97
The ICSI Technology Assessment Committee finds that tongue retaining devices and mandibular repositioning devices have not been proven effective for treatment of obstructive sleep apnea syndrome (OSAS). The continuous positive airway pressure (CPAP) device is the standard treatment for patients with OSAS. Some oral devices may be an option for selected patients with mild to moderate OSAS who have not responded to or cannot tolerate treatment with the CPAP device.
Morbid Obesity Surgery - Order # T14
Adopted: 06/10/94
Updated: 10/02/96
The ICSI Technology Assessment Committee finds gastric restrictive surgery for morbid obesity to be a safe surgical procedure. However, the impact of surgery on obesity-related morbidity and mortality has not been examined in controlled studies. Therefore, the efficacy of gastric restrictive surgery for morbid obesity is not proven. Anecdotal evidence suggests that super obese patients experiencing disabling or life threatening medical complications associated with their obesity may benefit from the procedure.
Home Uterine Activity Monitoring - Order # T15
Adopted: 06/10/94
Updated: 11/13/96
The ICSI Technology Assessment Committee finds home uterine activity monitoring (HUAM) to be safe for the detection of preterm labor. However, its effectiveness in improving clinical outcome has not been established in the literature. Anecdotal evidence suggests that HUAM may be useful in the following circumstances:
  1. Patients with multiple gestations.
  2. Patients with a history of preterm birth.
  3. In lieu of hospitalization for patients diagnosed with preterm labor.
Prenatal Ultrasound as a Screening Test - Order # T16
Adopted: 07/06/94
Reviewed: 09/01/96
The ICSI Technology Assessment Committee finds that the use of routine ultrasound screening in low risk populations is safe but not effective, as it does not alter pregnancy outcomes. However, selective use of ultrasound is beneficial for patients with specific clinical indications.
Stereotactically Directed Fine-Needle Aspiration Biopsy (FNAB) and Core Biopsy of Nonpalpable Breast Lesions - Order # T17
Adopted: 07/06/94
Reviewed: 10/01/96
The ICSI Technology Assessment Committee finds stereotactically directed core biopsy to be safe and effective for selected patients with indeterminate, nonpalpable breast lesions. Stereotactically-directed fine-needle aspiration biopsy, although safe, has not been proven effective as a stand-alone biopsy method.
Acupuncture for Treatment of Chemical Dependency - Order # T18
Adopted: 10/05/94
Reviewed: 10/01/96
The ICSI Technology Assessment Committee finds auricular acupuncture to be a safe adjuvant treatment modality for chemical dependency. Acupuncture has not been proven effective for use in treating chemical dependency.
Intrathecal Baclofen Infusion for Controlling Spasticity and Spasms - Order # T19
Adopted: 10/05/94
Reviewed: 09/01/96
The ICSI Technology Assessment Committee finds intrathecal baclofen safe and effective for selected patients with intractable spasticity and spasms.
Tympanic Ear Thermometers - Order # T20
Adopted: 03/01/95
Reviewed: 02/04/97
The ICSI Technology Assessment Committee finds tympanic ear thermometers to be safe and effective for routine body temperature evaluation, but should not be used in critically ill patients or in patients for whom a decision regarding work-up or therapy is based on this measurement.
EEG During Carotid Artery Surgery - Order # T21
Adopted: 03/01/95
The ICSI Technology Assessment Committee finds that EEG monitoring is a safe and effective method of showing cerebral lack of perfusion. It is unknown whether EEG monitoring will prevent stroke in patients undergoing carotid endarterectomy (CEA) surgery.
Transjugular Intrahepatic Porto-Systemic Shunts - Order # T22
Adopted: 09/25/95
Reviewed: 08/01/96 The ICSI Technology Assessment Committee finds the long-term safety and efficacy of TIPS cannot yet be made due to the lack of randomized, controlled trials which are currently underway. The case series published to date have indicated that TIPS appears to be a safe and effective means of decompressing the portal venous system and controlling acute variceal bleeding in the short term. The only reference evidence to date is class c.
Lung Reduction Surgery - Order # T23
Adopted: 09/25/95
The ICSI Technology Assessment Committee finds that the results to-date of lung reduction surgery for emphysema show a definite improvement in lung function,Lrcise tolerance and psychosocial status, among undifferentiated and poorly defined groups of patients. The short-term results of bilateral (volume reduction) pneumectomy surgery appear promising. However, to better define appropriate indications and long-term results, patients requiring lung reduction surgery should be enrolled in carefully designed scientifically valid clinical trials conducted at institutions with the necessary expertise. Accordingly, longer-term data are critical before assessment of safety and efficacy of reduction pneumoplasty is possible. The only reference evidence to date is class c.
Stereotactic Radioneurosurgery for Brain Lesions - Order # T24
Adopted: 3/06/96
The ICSI Technology Assessment Committee finds that radiosurgery is a viable option for patients with brain lesions usually no larger than 3-4 cm in maximum dimension who are at high risk for or who decline conventional surgery. It is also a viable option as an adjunct therapy. The procedure is effective and relatively safe in comparison to open surgery although long-term follow-up is needed.
High-Dose Chemotherapy with Hematopoietic Stem Cell Transplantation for Treatment of Multiple Myeloma - Order # T25
Adopted: 04/17/96
The ICSI Technology Assessment Committee finds that high-dose chemotherapy with allogeneic hematopoietic stem cell transplantation for multiple myeloma is a high-risk procedure, the efficacy of which has yet to be proved in randomized, controlled trials. Autologous transplantation is associated with limited toxicity but future research is needed to establish whether it has the ability to prolong survival. All patients considered for allogeneic or autologous transplantation should be enrolled in randomized local or national clinical trials.
Botulinum Toxin Therapy - Order # T26
Adopted: 07/10/96
The ICSI Technology Assessment Committee finds botulinum toxin to be safe and effective for treatment of strabismus, blepharospasm, and hemifacial spasm when administered in appropriate doses by physicians trained in its administration. The available evidence also supports the effectiveness and safety of the toxin in the treatment of cervical dystonia (spasmodic torticollis), jaw-closing oromandibular dystonia (orofacial dyskinesia, Meige syndrome), and adductor spasmodic dysphonia; but the Food and Drug Administration (FDA) has not approved its use for these applications. Some evidence also exists to support the effectiveness and safety of treatment with the toxin for cerebral palsy; this evidence consists of several case series reports and one randomized, controlled trial published in abstract form. Again, its use for this indication is not FDA-approved. Although some evidence suggests that botulinum toxin is effective for treatment of selected patients with jaw-opening oromandibular dystonia, focal and segmental limb dystonia, and abductor spasmodic dysphonia, conclusions about long-term effectiveness and safety cannot be made for these applications because the available evidence is too limited. Available evidence includes several class A and several class C studies.
Small Bowel Transplantation - Order # T27
Adopted: 07/10/96
The ICSI Technology Assessment Committee finds small bowel transplant (SBT) and combined liver-small bowel transplant to be clinically effective for selected patients with short bowel syndrome with and without end-stage liver disease. Clinical experience suggests that small bowel transplant and combined liver-small bowel transplant are clinical options that should be reserved for patients whose intestinal failure is irreversible and when life threatening complications of total parenteral nutrition (TPN) become unmanageable. All evidence to date is Class C.
Tissue -Type Plasminogen Activator for Acute Ischemic Stroke - Order # T28
Adopted: 08/21/96
The ICSI Technology Assessment Committee finds that intravenous rt-PA (0.9 mg/kg to a maximum of 90 mg) is an efficacious although potentially risky treatment for acute ischemic stroke if administered within 3 hours of definite onset of symptoms with the strict inclusion and exclusion criteria proposed in this report. The treatment should only be administered in a setting of medical care with expertise in treating acute stroke so that all criteria proposed in the NINDS trial can be emulated.
Magnetic Resonance Angiography for Venous Sinus Thrombosis, Intracranial Atherosclerosis, Intracranial Aneurysms, Carotid Artery Atherosclerosis, and Carotid or Vertebral Artery Dissection - Order # T29
Adopted: 12/18/96
The ICSI Technology Assessment Committee finds that MRA is a safe technique that continues to evolve and is gaining wider acceptance for a variety of indications. At this point, MRA has been proven to be efficacious for the diagnosis of venous sinus thrombosis, for the diagnosis of carotid artery atherosclerosis (when preceded by ultrasound), and for the diagnosis and follow-up of carotid artery dissection. There is a need for continued research, especially prospective, randomized clinical trials. To date, the evidence is primarily Grade C.
Dorsal Rhizotomy for Spasticity - Order # T30
Adopted: 01/29/97
The ICSI Technology Assessment Committee finds that dorsal rhizotomy is a safe and effective procedure when performed on appropriately selected patients at a center with an experienced team that includes specialists in pediatric neurosurgery, orthopedics, neurology, and physiatry. Lower extremity spasticity is reduced following rhizotomy although the long-term effects have not been studied. Functional changes do occur and may be optimized by careful patient selection. Additional research is needed to define the criteria used to intraoperatively identify normal and abnormal rootlets.
Densitometry as a Screening Tool for Osteoporosis in Women - Order # T31
Adopted: 03/28/97
The ICSI Technology Assessment Committee finds that osteoporosis is a significant health issue for which the value of preventive interventions has been proven. Some interventions can be initiated without screening for bone density and all available options should be explained to all patients. Mass screening is not recommended but selective testing is of value when making individual decisions about therapies. Due to the limitations of the measurement systems, annual testing is not clinically indicated.
Pulmonary Rehabilitation for Chronic Obstructive Pulmonary Disease - Order # T32
Adopted: 03/28/97
The ICSI Technology Assessment Committee finds that there is Grade A evidence indicating that hospital-based pulmonary rehabilitation programs are effective in improving exercise capacity, quality of life, and perception of symptoms but only for the duration of the program, typically 8 to 12 weeks. Pulmonary function measurements are not beneficially affected. The programs are generally safe and benefits are maximized by a multidisciplinary approach (education, exercise, psychosocial support, etc.). There is some evidence that home-based programs may provide benefit for up to 18 months. More research is needed to clarify questions related to patient selection, program components, and long- term effects.
Genetic Screening For Breast Cancer - Order # T33
Adopted: 07/28/97
The ICSI Technology Assessment Committee finds that genetic screening for breast and ovarian cancer risk, and molecular diagnostic testing for mutations in cancer susceptibility genes represent technologies which are in evolution. These technologies offer the potential to identify people who are high risk for breast and ovarian cancer. These people, and their family members, can be offered education, genetic counseling, programs of increased surveillance, prophylactic surgery, and other measures to reduce their risk of cancer. Patients who are at increased risk should be referred to a program for risk assessment and genetic counseling prior to the consideration for molecular diagnostic testing. Molecular diagnostic testing should be offered only after expert counseling, provided that the patient willingly consents to testing, confidentiality can be maintained, laboratory standards are regulated, and clinicians are adequately prepared to address the complex social, ethical and legal issues associated with genetic testing. Laboratories used for screening purposes should be participating in clinical research trials to define the appropriate use of screening studies.

Electron-Beam Computed Tomography for Coronary Artery Disease - Order # T34
Adopted: 7/28/97
The ICSI Technology Assessment Committee finds the EBCT is a safe procedure that can be used as part of a cardiological examination done under supervision of a physician knowledgeable about the significance of scan results. There is insufficient data to recommend EBCT in lieu of stress testing for most patients with chest pain except those with atypical chest pain for whom a negative study may provide useful data. The role of EBCT in screening asymptomatic patients with conventional risk factors is not yet clearly defined. Although patients with coronary artery disease have been found to have greater degrees of calcification, there is no direct one-to-one relationship between EBCT- detected coronary calcium and luminal stenosis detected at coronary angiography.

Electrical Stimulation for Non-Union of a Fracture - Order # T35
Adopted: 08/27/97
The ICSI Technology Assessment Committee finds that DC, CC, and IC methods are safe and can be performed on an outpatient basis. Each method has been shown to be effective although the exact mechanism for stimulation of bone healing remains unknown and is likely different for the three methods. The evidence, to date, is mostly Grade C with the exception of 2 Grade A studies. Electrical stimulation appears to be at least as effective as bone grafting and standard fixation methods for the management of established non-united fractures. There is no consensus on the indications. Based on the available literature, the Committee concludes that electrical stimulation should be limited to the indications listed above.

Acupuncture for Chronic Osteoarthritis Pain, Headache, and Low Back Pain - Order # T36
Adopted: 10/08/97
This report focuses on the use of acupuncture for treatment of specific types of chronic pain for which there exist controlled trials. The trials, however, are limited by flaws pertaining to the experimental model of pain, difficulties in selecting an appropriate control group, and differences in acupuncture technique. Acupuncture appears to be effective in certain chronic pain conditions although, at present, it is not possible to identify whether a specific patient is likely to benefit. If acupuncture is being considered, it must be part of a comprehensive treatment program. It is a safe procedure when performed by properly trained individuals in a clinical environment using sterile, disposable needles.
Computed Tomography for the Diagnosis of Pulmonary Embolism - Order # T37
Adopted: 01/05/98
With regard to the use of contrast-enhanced CT for the diagnosis of acute PE, the ICSI Technology Assessment Committee finds that all forms of CT are safe.� Conventional CT is of limited value in the diagnosis of PE.� Helical CT has good diagnostic accuracy (sensitivity of 75% to 95%; specificity of 78% to 97%) and higher sensitivity and interobserver agreement than V/Q scanning.� EBCT appears to be at least as well-suited for the diagnosis of PE as helical CT and may be preferred for patients with difficulty holding their breath, however, there is limited data on diagnostic accuracy. Compared to PA and V/Q scanning, the reduced time required for and less invasive nature of helical or electron-beam CT would appear to be beneficial for the critically ill patient.� At present, there is no clear consensus on the exact role of helical or electron-beam CT, although recent evidence indicates that helical CT may be used in initial screening or as a follow-up to a V/Q scan.� The technology continues to evolve and future developments will likely enhance the diagnostic accuracy.
Assisted Reproductive Technologies - Order # T38
Adopted: 01/30/98
The ICSI Technology Assessment Committee finds that ART are safe although the potential long-term consequences for both the mother and child remain unknown.� Severe ovarian hyperstimulation syndrome has been reported in about 1% of patients undergoing ovarian stimulation.� The incidence of congenital abnormalities is no higher than in the general population.� The success of ART decreases with maternal age.� Nationwide, the live birth per cycle rate was 20% (17-33% in Minnesota) and the clinical pregnancy rate was 24% (26 to 39% in Minnesota).� IVF-ET has been found (in Grade B studies) to be as effective as other ART (including GIFT and ZIFT).� The technology associated with IVF-ET (either with or without ICSI) continues to evolve making IVF the most effective of the ART.
Screening for the Factor V R506Q (Leiden) Mutation Prior to Oral Contraceptive Prescription - Order # T40
Committee Summary
At present, there is insufficient evidence that early diagnosis would lead to an improved clinical outcome. The standard APC-resistance test is safe and acceptable but the sensitivity and specificity vary depending on the assay method, the cut-off point chosen, and pre-analysis sample collection, storage, and transport. Routine screening is not recommended. However, it may be worthwhile to screen asymptomatic women with a family history of either VTE or the fV R506Q mutation provided that the test results would affect medical management. Appropriate counseling is required prior to screening asymptomatic women.
Written January, 1998
Minimally Invasive Direct Vision Coronary Artery Bypass Grafting (MIDCABG) - Order # T4138
Committee Summary
With regard to MIDCABG, the ICSI Technology Assessment Committee finds Written January, 1998
Photodynamic Therapy for Head and Neck, Tracheobronchial, and Esophageal Cancer - Order # T39
Committee Summary
The ICSI Technology Assessment Committee finds that PDT has a faster treatment course, is less expensive, and is associated with lower morbidity than surgical resection for palliation or radiation for early disease and palliation. In the absence of randomized, controlled trials, PDT has been shown (Grade C evidence) to be effective in producing a complete response for stage I cancers and carcinoma in situ of the larynx, oral cavity, tracheobronchial tree, and esophagus. The duration of the complete response varies with the site of cancer. Adenocarcinoma associated with Barrett's esophagus has also been shown to respond to PDT. For advanced cancers, PDT has been shown to have a palliative effect, improving the patient's quality of life. For patients with recurrent head and neck cancers, PDT has been observed to be effective as an adjuvant intraoperative treatment.
Written September, 1997
Order Form

[Home]