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Bruening W, Schoelles K, Treadwell J, et al. Comparative Effectiveness of Core-Needle and Open Surgical Biopsy for the Diagnosis of Breast Lesions [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2009 Dec. (Comparative Effectiveness Reviews, No. 19.)
Comparative Effectiveness of Core-Needle and Open Surgical Biopsy for the Diagnosis of Breast Lesions [Internet].
Show detailsQuality Assessment
- Was patient recruitment either consecutive or random?
- Were at least 85% of the patients recruited for enrollment actually enrolled?
- Were the patient inclusion/exclusion criteria consistently applied to all patients?
- Was the study free from obvious spectrum bias? Obvious spectrum bias was defined as more than 40% or less than 10% of the breast lesions were diagnosed as malignant; and/or the mean or median age of the enrolled population was less than 50 or greater than 70.
- Was the study prospective in design?
- Was a complete set of data reported for at leas t 85% of enrolled lesions?
- Were the patients assessed by the gold standard (open surgical procedure) regardless of the initial biopsy results?
- Were patients assessed by a reference standard regardless of the biopsy results?
- Was funding for this study provided by a source that doesn’t have an obvious financial interest in the findings of the study?
- Did the study account for inter-reader/score differences?
- Were the reader(s) of the biopsies blinded to the results of the reference standard?
- Were readers of the reference standard blinded to the results of the biopsy?
- Were the readers of the biopsy blinded to all other clinical information?
- Were readers of the reference standard blinded to all other clinical information?
Study Design
- Design of study
- Study was prospective or retrospective?
- Number of centers
- Care setting
- Country study conducted in
- Study funded by
- How many different people performed core-needle biopsies during the course of the study?
- What is the training of the persons performing the core-needle biopsies?
- What is the experience of the persons performing the core-needle biopsies?
- Describe in detail the methods used to perform the biopsies
- Who is interpreting the biopsy specimens, and what kind of training do they have?
- Biopsy results confirmed by comparing them to what?
- Describe in detail the reference standard
Patient Details
- Describe the inclusion criteria
- Describe the exclusion criteria
- Number of patients recruited/approached about enrollment
- Number of patients and lesions enrolled
- Number of lesions completing the study
- Age, median or mean, range
- Other reported age discriptors such as % post-menopausal
- Ethnicity
- Types of lesions enrolled and number of each
Accuracy Data
- Enter the type of biopsy being used for the following set of data
- How manylesions were biopsied?
- How many technical failures/inadequate biopsies occurred?
- How many were lost to followup?
- How many lesions were diagnosed as benign and what was the final diagnosis for each
- How many lesions were diagnosed as invasive and what was the final diagnosis for each
- How many lesions were diagnosed as DCIS and what was the final diagnosis for each
- How many lesions were diagnosed as Atypical, Suspicious, or High Risk, and what was the final diagnosis for each
- Where there any other diagnoses on core-needle biopsy and if so what were they and what was the final diagnosis for each
- Enter information about accuracy by lesion characteristics
- Enter information about accuracy by patient characteristics
- Enter information about accuracy by biopsy methodology characteristics
- Enter any other reported information affected biopsy accuracy
Harms Data
- Requirement for a repeated biopsy procedure, rate
- Complications of the biopsy procedure, types and rates of
- Time to recovery or time to return to work
- Use of pain medications
- Patient satisfaction, quality of life data
- Impact of biopsy procedure on accuracy of subsequent mammography procedures
- Any other harms info reported by the study
- Data Abstraction Forms - Comparative Effectiveness of Core-Needle and Open Surgi...Data Abstraction Forms - Comparative Effectiveness of Core-Needle and Open Surgical Biopsy for the Diagnosis of Breast Lesions
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