Quality 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
Publication Details
Copyright
Publisher
Agency for Healthcare Research and Quality (US), Rockville (MD)
NLM Citation
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.) Appendix D, Data Abstraction Forms.