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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

Systematic review: comparative effectiveness of core-needle and open surgical biopsy to diagnose breast lesions

W Bruening, J Fontanarosa, K Tipton, JR Treadwell, J Launders, and K Schoelles.

Review published: 2009.

Link to full article: [Journal publisher]

CRD summary

This review concluded that stereotactic- and ultrasonography-guided core needle biopsies were almost as accurate as open surgical biopsy for the diagnosis of breast cancer and had lower complication rates. The conclusions should be treated with caution because of limitations in the review methodology and the evidence base.

Authors' objectives

To compare the accuracy and harms of different breast biopsy methods in average-risk women with suspected breast cancer.

Searching

The authors searched CINAHL, The Cochrane Library, DARE, ECRI Institute Library Catalogue, EMBASE, HTA database, Healthcare Standards, International Health Technology Assessment, MEDLINE, PREMEDLINE, NHS EED and US National Guideline Clearinghouse. Search terms were reported. Search dates spanned 1990 to September 2009. The search was limited to peer-reviewed studies published in English.

Study selection

Diagnostic accuracy studies were eligible for the review if they directly compared core-needle biopsy with a reference standard of open surgical biopsy or clinical follow-up for at least six months. Studies had to enroll at least 10 women referred for diagnosis of a breast abnormality and report full data for at least 50% of patients enrolled. Case-control studies and studies of women thought to be at very high risk of breast cancer were excluded.

The most commonly used core-needle biopsy techniques were stereotactic and ultrasonographic guidance, using either automated or vacuum-assisted devices. Some included studies evaluated multiple methods. Participants were identified by mammography or physical examination. The most common setting was a general hospital. When follow-up was used as a reference standard, average or total follow-up ranged from 12 to 55 months.

Three reviewers independently selected studies for inclusion in duplicate; disagreements were resolved by a fourth reviewer.

Assessment of study quality

Quality was assessed by one reviewer using a modified (14-item) version of the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) instrument. This was used to calculate an overall quality score (1 for yes, -1 for no and 0 for unsure) for each study, which was normalised to a 0 to 10 scale.

Data extraction

Sensitivity and negative likelihood ratio were extracted or calculated. Underestimation rates (lesions identified as benign or localised cancer by core needle biopsy, but malignant or invasive by the reference standard ) were also determined (on a per-lesion basis) where reported. Data were extracted by one reviewer and checked for accuracy by a second.

Methods of synthesis

Pooled estimates of sensitivity and negative likelihood ratio, with 95% confidence interval (CI), were calculated using a bivariate mixed-effects binomial regression model. Summary likelihood ratios and Bayes' theorem were used to calculate the post-test probability of having a benign or malignant lesion. If the bivariate binomial model could not be fitted, a random-effects model was used. Heterogeneity was assessed using the I2 statistic. Underestimation rates and other outcomes were synthesised by meta-analysis using a random-effects model.

The strength of evidence that supported each major finding was assessed based on the risk of bias of the evidence base (determined from the median quality score of studies that contributed to that finding), precision of summary estimates, consistency across studies and robustness (tested by sensitivity analysis). Meta-regression analyses were performed to identify factors that potentially affected the accuracy and harmful effects of core needle biopsy.

Results of the review

A total of 107 diagnostic cohort studies (57,088 breast lesions) were included; of these, 44 were retrospective and 29 did not report the method of data collection. Study quality was rated low overall, primarily because of poor reporting of clinical details.

Diagnostic accuracy: Pooled sensitivity estimates ranged from 99.2% (95% CI 98.1 to 99.6) for stereotactic guidance and a vacuum-assisted device to 83.3% (95% CI 43.5 to 96.5) for an automated gun guided by magnetic resonance imaging (MRI). Pooled negative likelihood ratios and underestimation rates (where calculable) were lower for stereotactic guidance and a vacuum-assisted device than for other biopsy types. The strength of evidence for these findings was rated as low.

Harmful effects: Low strength evidence indicated that severe complications were less common after core needle biopsy (0.09% to 0.72%) compared with open surgical biopsy (2% to 10%). Women with cancer diagnosed by core needle biopsy were more likely than those diagnosed by surgical biopsy to be treated with a single surgical procedure (moderate strength evidence). Data on other complications were reported.

Meta-regression: Meta-regression analysis suggested that use of image guidance and vacuum assistance improved the accuracy of core needle biopsy, but vacuum assistance was associated with increased risk of severe bleeding and haematoma formation.

Authors' conclusions

Stereotactic- and ultrasonography-guided core needle biopsies seemed to be almost as accurate as open surgical biopsy and had lower complication rates.

CRD commentary

The review addressed a well-defined question and had clear inclusion criteria. The search for published studies was thorough, but limiting the review to English language studies risked language bias. A diagnostic filter was used in the search, which may have resulted in relevant studies being missed. Unpublished studies were excluded, which raised the risk of publication bias.

The quality of included studies and overall strength of evidence were assessed with appropriate criteria and the results were used in the synthesis. However, the calculation of a composite quality score from the QUADAS results was inappropriate and meant that readers could not determine which studies were subject to which types of bias. It appeared that validity assessment was conducted by one person, which increased the risk of errors and bias. Measures were taken to minimise errors and bias in study selection and data extraction. Full details of included studies were available in the paper or the full report.

Data on diagnostic accuracy outcomes were synthesised by meta-analysis to produce pooled estimates of sensitivity and negative likelihood ratio. The methods used were chosen to compensate for statistical heterogeneity between studies and seem appropriate. However, clinical heterogeneity between studies was present and this could affect the reliability of the meta-analysis. The authors stated that statistical heterogeneity was assessed, but the results were not reported in the paper.

In view of these issues and the low quality of the evidence, the authors' conclusions should be treated with caution.

Implications of the review for practice and research

Practice: The authors stated that the routine use of stereotactically guided vacuum-assisted and ultrasonography-guided core needle biopsy was justified.

Research: The authors stated that further research was required to investigate factors that affected the accuracy and harmful effects of core needle biopsy, and to evaluate the accuracy and safety of MRI-guided biopsy. They also stated that further well designed and reported studies were necessary to confirm the conclusions of the review.

Funding

Agency for Healthcare Research and Quality (contract no. 290-02-0019).

Bibliographic details

Bruening W, Fontanarosa J, Tipton K, Treadwell JR, Launders J, Schoelles K. Systematic review: comparative effectiveness of core-needle and open surgical biopsy to diagnose breast lesions. Annals of Internal Medicine 2009; 152(4): 238-246. [PubMed: 20008742]

Other publications of related interest

Bruening W, Schoelles K, Treadwell JR, Launders J, Fontanarosa J, Tipton K. Comparative effectiveness of core-needle and open surgical biopsy for the diagnosis of breast lesions. Comparative Effectiveness Review No. 19. Rockville, MD: Agency for Healthcare Research and Quality.

Indexing Status

Subject indexing assigned by NLM

MeSH

Biopsy /adverse effects /methods; Biopsy, Needle /adverse effects /methods; Breast /pathology /surgery; Breast Neoplasms /pathology; Evidence-Based Medicine; Female; Humans; Risk; Sensitivity and Specificity; Stereotaxic Techniques; Ultrasonography, Mammary; Vacuum

AccessionNumber

12009110393

Database entry date

20/01/2010

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.

CRD has determined that this article meets the DARE scientific quality criteria for a systematic review.

Copyright © 2014 University of York.

PMID: 20008742

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