Learning What Works Infrastructure Required for Comparative Effectiveness Research: Workshop Summary (2011) / Chapter Skim
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Appendix B: Comparative Effectiveness Studies Inventory Project
Appendix B: Comparative Effectiveness Studies Inventory Project
Pages 439-468
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Appendix B Comparative Effectiveness Studies Inventory Project A commissioned activity for the IOM Roundtable on Evidence-Based Medicine In 2008, a working group was formed at the request of the IOM Roundtable on Evidence-Based Medicine to identify and consider compelling comparisons of clinical interventions in order to inform and advance discussions of criteria important to determining priorities for assessment, to identify a list of possible interventions to be considered, and to offer observations on the kinds of studies needed. Material was presented in draft form at the July 2008 IOM workshop on infrastructure needs for comparative effectiveness research and delivered in final form in March 2009.
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0 LEARNING WHAT WORKS STUDY TOPIC SUMMARIES Diagnosis and prognosis of breast cancer using genetic tests: HER2 and others Drug treatment of depression in primary care Drug treatment of epilepsy in children Gamma knife surgery for multiple types of intracranial lesions: comparison with surgery and/or whole brain radiation Inguinal hernia repair: open vs. minimally invasive Outcomes of percutaneous coronary interventions in hospitals with and without onsite surgical backup Over-the-counter drug treatment of upper respiratory tract infections in children Prevention and treatment of pressure ulcers Screening hospital inpatients for methicillin-resistant Staphylococcus aureus infection Tobacco cessation: nicotine replacement agents, oral medications, combinations Treatment of acute thrombotic/embolic stroke: clot removal, reperfusion drugs Treatment of ADHD in children: drugs, behavioral interventions, no Rx Treatment of chronic atrial fibrillation: drugs, catheter ablation, surgery Treatment of chronic low back pain Treatment of localized prostate cancer: watchful waiting, surgery, radiation, or cryotherapy Use of erythropoiesis-stimulating agents in the treatment of hematologic cancers
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Many clinical practice guidelines and health system guidance documents now routinely approve HER2 testing and trastuzumab treatment for women with recurrent breast cancer. Prospective studies of Oncotype DX are less common.
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. Generally, the strongest evidence is gathered from prospective studies in which markers are used to determine treatment or other allocation groups, although retrospective analysis can also produce valid results.
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Issues needing research, and conclusions Large, head-to-head randomized trials with heterogeneous primary care populations of depressed patients are needed to better understand the benefits and harms of the various antidepressant agents. Observational studies using large databases may provide some of the needed evidence, but without randomization, conclusions may be difficult to obtain.
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Cochrane Database of Systematic Reviews, Issue 4.
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Epileptic Disorders 9:353-412. Gamma Knife Surgery for Multiple Types of Intracranial Lesions: Comparison with Surgery and/or Whole Brain Radiation Brief description of the condition or problem Gamma knife surgery (GKS)
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For example, a systematic review of GKS in the treatment of trigeminal neuralgia found 23 case series but no randomized trials. Whereas GKS has become an accepted treatment for certain types of small intracranial lesions, the need for randomized evidence is made clear by the experience with GKS as adjunctive treatment for malignant, infiltrative tumors such as glioblastoma multiforme.
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Randomized trials have found that laparoscopic repairs take longer and are more expensive to
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versus totally extraperitoneal (TEP) laparoscopic techniques for inguinal hernia repair: A systematic review.
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Current evidence Numerous case series and case-control studies have shown that PCI can be done safely in selected individual hospitals without onsite cardiac surgery. In these studies, PCI success rates and mortality rates are similar to those at hospitals with onsite surgery.
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2008. Outcomes of 1,090 consecutive, elective, nonselected percutaneous coronary interventions at a community hospital without onsite cardiac surgery.
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Current evidence Antipyretics are safe and effective in reducing fever in children when used as directed. Multiple randomized trials of variable quality have evaluated the other OTC medications for cough and cold and have not found clear evidence of efficacy.
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Once pressure ulcers have occurred they can be treated with all of the above plus dressings of various types, multiple types of topical treatments, and antibiotics when appropriate. Current evidence There is good evidence supporting most preventive/nursing measures, such as frequent turning of bedbound patients and prevention of excess moisture.
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Annals of Internal Medicine 239:694-695. Screening Hospital Inpatients for Methicillin resistant Staphylococcus aureus Infection Brief description of the condition or problem Hospital infections take an enormous toll in the United States, leading to nearly 100,000 deaths and added costs of $6.5 billion annually.
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State legislatures have also become vocal on this issue, introducing and occasionally passing legislation requiring hospital MRSA screening. Current evidence Standard hospital infection control procedures can and have led to decreased MRSA infection rates.
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Recently published randomized trials of rapid screening tests have reported mixed results, confirming the ability of PCR to identify MRSA carriers quickly but failing to find decreases in MRSA acquisition and/or surgical infection rates resulting from the interventions. Issues needing research, and conclusions Despite much research, discussion, and attention, this topic could benefit from further research.
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and oral medications. Available nicotine replacement preparations include transdermal patches, gum, inhalers, nasal spray, and lozenges.
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Multiple types of percutaneous endovascular therapies are also available for physical clot removal, including clot retrieval devices, suction thrombectomy devices, laser or ultrasound devices, mechanical clot disruption and fragmentation devices, and intracranial angioplasty with or without stents.
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Cochrane Database of Systematic Reviews, Issue 2.
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Current evidence Drug therapy is widely regarded as the mainstay of treatment for moderate to severe ADHD, with clear evidence of superiority of all drug types over placebo. Behavioral therapy and other non-pharmacologic treatments have also been shown to be more effective than placebo but have generally not been found to be as good as drug therapy.
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International Journal of Clinical Practice 61:1730-1738. Treatment of Chronic Atrial Fibrillation: Drugs, Catheter Ablation, Surgery Brief description of the condition or problem Atrial fibrillation (AF)
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As more centers become skilled in catheter ablation techniques, large effectiveness rather than efficacy studies will be useful to determine the best clinical guidance for patients with diverse risk factors and comorbidities. Most likely new, randomized trials will have to be undertaken to answer these questions, as current data are probably unsuitable for systematic review.
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Available treatments or interventions The main choice in managing chronic low back pain is whether to continue medical management or undergo spinal surgery. Medical management can include the following interventions individually or in combination: pain, anti-inflammatory, and other medications; physical and rehabilitation therapy and other types of exercise programs: acupuncture and acupressure: cognitive-behavioral therapy: spinal manipulation: massage: and other treatments.
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Again, few head-to-head trials have been conducted, and trials including multiple interventions are also uncommon. At least six randomized trials have compared lumbar fusion surgery with some type of intensive nonsurgical management for chronic low back pain, with conflicting results.
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2007. Medications for acute and chronic low back pain: A review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline.
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Brachytherapy has fewer side effects because the radiation dose is lower than external beam radiation, but the clinical effectiveness is not as well demonstrated as other types of radiation. Cryotherapy has not been tested in many randomized trials comparing it to more conventional treatments, and its effectiveness has mainly been documented in case series.
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Cochrane Database of Systematic Reviews, Issue 3.
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Current evidence Numerous randomized and non-randomized trials have established that erythropoiesis-stimulating agents increase hemoglobin levels and reduce transfusion requirements in cancer patients with anemia. They also decrease fatigue and increase quality of life.
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2008. Use of epoetin and darbepoetin in patients with cancer: 2007 American Society of Clinical Oncology/American So ciety of Hematology clinical practice guideline update.
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