Kelley Tipton

Systematic Review: Comparative Effectiveness of Core-Needle and Open Surgical Biopsy to Diagnose Breast Lesions

BACKGROUND Most women undergoing breast biopsy are found not to have cancer. PURPOSE To compare the accuracy and harms of different breast biopsy methods in average-risk women suspected of having breast cancer. DATA SOURCES Databases, including MEDLINE and EMBASE, searched from 1990 to September 2009. STUDY SELECTION Studies that compared core-needle biopsy diagnoses with open surgical diagnoses or clinical follow-up. DATA EXTRACTION Data were abstracted by 1 of 3 researchers and verified by the primary investigator. DATA SYNTHESIS 33 studies of stereotactic automated gun biopsy; 22 studies of stereotactic-guided, vacuum-assisted biopsy; 16 studies of ultrasonography-guided, automated gun biopsy; 7 studies of ultrasonography-guided, vacuum-assisted biopsy; and 5 studies of freehand automated gun biopsy met the inclusion criteria. Low-strength evidence showed that core-needle biopsies conducted under stereotactic guidance with vacuum assistance distinguished between malignant and benign lesions with an accuracy similar to that of open surgical biopsy. Ultrasonography-guided biopsies were also very accurate. The risk for severe complications is lower with core-needle biopsy than with open surgical procedures (<1% vs. 2% to 10%). Moderate-strength evidence showed that women in whom breast cancer was initially diagnosed by core-needle biopsy were more likely than women with cancer initially diagnosed by open surgical biopsy to be treated with a single surgical procedure (random-effects odds ratio, 13.7 [95% CI, 5.5 to 34.6]). LIMITATION The strength of evidence was rated low for accuracy outcomes because the studies did not report important details required to assess the risk for bias. CONCLUSION Stereotactic- and ultrasonography-guided core-needle biopsy procedures seem to be almost as accurate as open surgical biopsy, with lower complication rates. PRIMARY FUNDING SOURCE Agency for Healthcare Research and Quality.

Stereotactic Body Radiation Therapy: Scope of the Literature

Stereotactic body radiation therapy (SBRT) is derived from the techniques of stereotactic radiosurgery used to treat lesions in the brain and spine. It combines multiple finely collimated radiation beams and stereotaxy to deliver a high dose of radiation to an extracranial target in the body in a single dose or a few fractions. This review provides a broad overview of the current state of SBRT for solid malignant tumors. Reviewers identified a total of 124 relevant studies. To our knowledge, no published comparative studies address the relative effectiveness and safety of SBRT versus other forms of external-beam radiation therapy. Stereotactic body radiation therapy seems to be widely diffused as a treatment of various types of cancer, although most studies have focused only on its use for treating thoracic tumors. Comparative studies are needed to provide evidence that the theoretical advantages of SBRT over other radiation therapies actually occur in the clinical setting; this area is currently being studied in only 1 small trial.

Assessing equivalence and noninferiority

OBJECTIVE For systematic reviews, no guidance exists for what review methods support valid conclusions of equivalence (EQ) and noninferiority (NI). To provide such guidance, we convened a workgroup of 13 experienced systematic reviewers from seven evidence-based practice centers (EPCs) and the Agency for Healthcare Research and Quality (AHRQ). STUDY DESIGN AND SETTING The Lead EPC first performed two methods projects intended to assist the workgroup in clarifying the context, prioritizing the issues, targeting the scope, and summarizing the state of the art. RESULTS Based on expert opinion, we devised guidance in four areas: 1) Unique risk of bias issues for trials self-identifying as EQ-NI trials; 2) Setting the reviewers minimum important difference; 3) Analytic foundations for concluding EQ or NI; and 4) Language considerations when concluding EQ or NI. CONCLUSION This article summarizes the main recommendations, and the full guidance chapter appears on the AHRQ Web site.