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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.)

Cover of Comparative Effectiveness of Core-Needle and Open Surgical Biopsy for the Diagnosis of Breast Lesions

Comparative Effectiveness of Core-Needle and Open Surgical Biopsy for the Diagnosis of Breast Lesions [Internet].

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Appendix DData Abstraction Forms

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

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