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The Cochrane Database of Systematic... Apr 2017Decision aids are interventions that support patients by making their decisions explicit, providing information about options and associated benefits/harms, and helping... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Decision aids are interventions that support patients by making their decisions explicit, providing information about options and associated benefits/harms, and helping clarify congruence between decisions and personal values.
OBJECTIVES
To assess the effects of decision aids in people facing treatment or screening decisions.
SEARCH METHODS
Updated search (2012 to April 2015) in CENTRAL; MEDLINE; Embase; PsycINFO; and grey literature; includes CINAHL to September 2008.
SELECTION CRITERIA
We included published randomized controlled trials comparing decision aids to usual care and/or alternative interventions. For this update, we excluded studies comparing detailed versus simple decision aids.
DATA COLLECTION AND ANALYSIS
Two reviewers independently screened citations for inclusion, extracted data, and assessed risk of bias. Primary outcomes, based on the International Patient Decision Aid Standards (IPDAS), were attributes related to the choice made and the decision-making process.Secondary outcomes were behavioural, health, and health system effects.We pooled results using mean differences (MDs) and risk ratios (RRs), applying a random-effects model. We conducted a subgroup analysis of studies that used the patient decision aid to prepare for the consultation and of those that used it in the consultation. We used GRADE to assess the strength of the evidence.
MAIN RESULTS
We included 105 studies involving 31,043 participants. This update added 18 studies and removed 28 previously included studies comparing detailed versus simple decision aids. During the 'Risk of bias' assessment, we rated two items (selective reporting and blinding of participants/personnel) as mostly unclear due to inadequate reporting. Twelve of 105 studies were at high risk of bias.With regard to the attributes of the choice made, decision aids increased participants' knowledge (MD 13.27/100; 95% confidence interval (CI) 11.32 to 15.23; 52 studies; N = 13,316; high-quality evidence), accuracy of risk perceptions (RR 2.10; 95% CI 1.66 to 2.66; 17 studies; N = 5096; moderate-quality evidence), and congruency between informed values and care choices (RR 2.06; 95% CI 1.46 to 2.91; 10 studies; N = 4626; low-quality evidence) compared to usual care.Regarding attributes related to the decision-making process and compared to usual care, decision aids decreased decisional conflict related to feeling uninformed (MD -9.28/100; 95% CI -12.20 to -6.36; 27 studies; N = 5707; high-quality evidence), indecision about personal values (MD -8.81/100; 95% CI -11.99 to -5.63; 23 studies; N = 5068; high-quality evidence), and the proportion of people who were passive in decision making (RR 0.68; 95% CI 0.55 to 0.83; 16 studies; N = 3180; moderate-quality evidence).Decision aids reduced the proportion of undecided participants and appeared to have a positive effect on patient-clinician communication. Moreover, those exposed to a decision aid were either equally or more satisfied with their decision, the decision-making process, and/or the preparation for decision making compared to usual care.Decision aids also reduced the number of people choosing major elective invasive surgery in favour of more conservative options (RR 0.86; 95% CI 0.75 to 1.00; 18 studies; N = 3844), but this reduction reached statistical significance only after removing the study on prophylactic mastectomy for breast cancer gene carriers (RR 0.84; 95% CI 0.73 to 0.97; 17 studies; N = 3108). Compared to usual care, decision aids reduced the number of people choosing prostate-specific antigen screening (RR 0.88; 95% CI 0.80 to 0.98; 10 studies; N = 3996) and increased those choosing to start new medications for diabetes (RR 1.65; 95% CI 1.06 to 2.56; 4 studies; N = 447). For other testing and screening choices, mostly there were no differences between decision aids and usual care.The median effect of decision aids on length of consultation was 2.6 minutes longer (24 versus 21; 7.5% increase). The costs of the decision aid group were lower in two studies and similar to usual care in four studies. People receiving decision aids do not appear to differ from those receiving usual care in terms of anxiety, general health outcomes, and condition-specific health outcomes. Studies did not report adverse events associated with the use of decision aids.In subgroup analysis, we compared results for decision aids used in preparation for the consultation versus during the consultation, finding similar improvements in pooled analysis for knowledge and accurate risk perception. For other outcomes, we could not conduct formal subgroup analyses because there were too few studies in each subgroup.
AUTHORS' CONCLUSIONS
Compared to usual care across a wide variety of decision contexts, people exposed to decision aids feel more knowledgeable, better informed, and clearer about their values, and they probably have a more active role in decision making and more accurate risk perceptions. There is growing evidence that decision aids may improve values-congruent choices. There are no adverse effects on health outcomes or satisfaction. New for this updated is evidence indicating improved knowledge and accurate risk perceptions when decision aids are used either within or in preparation for the consultation. Further research is needed on the effects on adherence with the chosen option, cost-effectiveness, and use with lower literacy populations.
Topics: Communication; Conservative Treatment; Decision Support Techniques; Elective Surgical Procedures; Health Knowledge, Attitudes, Practice; Humans; Patient Education as Topic; Patient Participation; Physician-Patient Relations; Publication Bias; Randomized Controlled Trials as Topic
PubMed: 28402085
DOI: 10.1002/14651858.CD001431.pub5 -
The Cochrane Database of Systematic... Apr 2018Recent progress in understanding the genetic basis of breast cancer and widely publicized reports of celebrities undergoing risk-reducing mastectomy (RRM) have increased... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Recent progress in understanding the genetic basis of breast cancer and widely publicized reports of celebrities undergoing risk-reducing mastectomy (RRM) have increased interest in RRM as a method of preventing breast cancer. This is an update of a Cochrane Review first published in 2004 and previously updated in 2006 and 2010.
OBJECTIVES
(i) To determine whether risk-reducing mastectomy reduces death rates from any cause in women who have never had breast cancer and in women who have a history of breast cancer in one breast, and (ii) to examine the effect of risk-reducing mastectomy on other endpoints, including breast cancer incidence, breast cancer mortality, disease-free survival, physical morbidity, and psychosocial outcomes.
SEARCH METHODS
For this Review update, we searched Cochrane Breast Cancer's Specialized Register, MEDLINE, Embase and the WHO International Clinical Trials Registry Platform (ICTRP) on 9 July 2016. We included studies in English.
SELECTION CRITERIA
Participants included women at risk for breast cancer in at least one breast. Interventions included all types of mastectomy performed for the purpose of preventing breast cancer.
DATA COLLECTION AND ANALYSIS
At least two review authors independently abstracted data from each report. We summarized data descriptively; quantitative meta-analysis was not feasible due to heterogeneity of study designs and insufficient reporting. We analyzed data separately for bilateral risk-reducing mastectomy (BRRM) and contralateral risk-reducing mastectomy (CRRM). Four review authors assessed the methodological quality to determine whether or not the methods used sufficiently minimized selection bias, performance bias, detection bias, and attrition bias.
MAIN RESULTS
All 61 included studies were observational studies with some methodological limitations; randomized trials were absent. The studies presented data on 15,077 women with a wide range of risk factors for breast cancer, who underwent RRM.Twenty-one BRRM studies looking at the incidence of breast cancer or disease-specific mortality, or both, reported reductions after BRRM, particularly for those women with BRCA1/2 mutations. Twenty-six CRRM studies consistently reported reductions in incidence of contralateral breast cancer but were inconsistent about improvements in disease-specific survival. Seven studies attempted to control for multiple differences between intervention groups and showed no overall survival advantage for CRRM. Another study showed significantly improved survival following CRRM, but after adjusting for bilateral risk-reducing salpingo-oophorectomy (BRRSO), the CRRM effect on all-cause mortality was no longer significant.Twenty studies assessed psychosocial measures; most reported high levels of satisfaction with the decision to have RRM but greater variation in satisfaction with cosmetic results. Worry over breast cancer was significantly reduced after BRRM when compared both to baseline worry levels and to the groups who opted for surveillance rather than BRRM, but there was diminished satisfaction with body image and sexual feelings.Seventeen case series reporting on adverse events from RRM with or without reconstruction reported rates of unanticipated reoperations from 4% in those without reconstruction to 64% in participants with reconstruction.In women who have had cancer in one breast, removing the other breast may reduce the incidence of cancer in that other breast, but there is insufficient evidence that this improves survival because of the continuing risk of recurrence or metastases from the original cancer. Additionally, thought should be given to other options to reduce breast cancer risk, such as BRRSO and chemoprevention, when considering RRM.
AUTHORS' CONCLUSIONS
While published observational studies demonstrated that BRRM was effective in reducing both the incidence of, and death from, breast cancer, more rigorous prospective studies are suggested. BRRM should be considered only among those at high risk of disease, for example, BRCA1/2 carriers. CRRM was shown to reduce the incidence of contralateral breast cancer, but there is insufficient evidence that CRRM improves survival, and studies that control for multiple confounding variables are recommended. It is possible that selection bias in terms of healthier, younger women being recommended for or choosing CRRM produces better overall survival numbers for CRRM. Given the number of women who may be over-treated with BRRM/CRRM, it is critical that women and clinicians understand the true risk for each individual woman before considering surgery. Additionally, thought should be given to other options to reduce breast cancer risk, such as BRRSO and chemoprevention when considering RRM.
Topics: Breast Neoplasms; Female; Genes, BRCA1; Genes, BRCA2; Genetic Predisposition to Disease; Humans; Observational Studies as Topic; Patient Satisfaction; Postoperative Complications; Prophylactic Mastectomy; Risk Assessment; Unilateral Breast Neoplasms
PubMed: 29620792
DOI: 10.1002/14651858.CD002748.pub4 -
Plastic and Reconstructive Surgery Oct 2022No meta-analysis has examined whether contralateral prophylactic mastectomy increases complication risk for unilateral breast cancer patients undergoing unilateral... (Meta-Analysis)
Meta-Analysis
BACKGROUND
No meta-analysis has examined whether contralateral prophylactic mastectomy increases complication risk for unilateral breast cancer patients undergoing unilateral mastectomy.
METHODS
Fifteen studies on complications of unilateral mastectomy plus contralateral prophylactic mastectomy met inclusion criteria. Meta-analyses compared complications of (1) diseased versus contralateral breasts in unilateral plus contralateral prophylactic mastectomy patients and (2) patients undergoing unilateral plus contralateral prophylactic mastectomy versus unilateral alone when grouped by reconstructive method.
RESULTS
For all unilateral plus contralateral prophylactic mastectomy patients, the diseased breast was significantly more prone to complications versus the contralateral breast (relative risk, 1.24; p = 0.03). In studies that stratified by reconstructive method, the complication risk was significantly higher for unilateral plus contralateral prophylactic mastectomy versus unilateral mastectomy alone for patients with no reconstruction (relative risk, 2.03; p = 0.0003), prosthetic-based reconstruction (relative risk,1.42; p = 0.003), and autologous reconstruction (relative risk, 1.32; p = 0.005). The only prospective trial showed similar results, including for more severe complications. Smaller retrospective studies without stratification by reconstructive method showed similar complications for unilateral plus contralateral prophylactic mastectomy versus unilateral mastectomy alone (relative risk, 1.06; p = 0.70). These groups had similar incidences of complication-related delay in adjuvant therapy, as demonstrated by one study.
CONCLUSIONS
After unilateral plus contralateral prophylactic mastectomy, diseased breasts are at higher risk for complications. Stronger evidence supports higher complication risk for unilateral plus contralateral prophylactic mastectomy than unilateral alone. More work is needed to determine the effect of complications on timing of adjuvant therapy.
Topics: Breast Neoplasms; Female; Humans; Mammaplasty; Mastectomy; Prophylactic Mastectomy; Prospective Studies; Retrospective Studies
PubMed: 35943952
DOI: 10.1097/PRS.0000000000009493 -
Annals of Surgery Dec 2014To examine whether contralateral prophylactic mastectomy (CPM) is associated with improved survival, incidence of contralateral breast cancer (CBC), and recurrence in... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To examine whether contralateral prophylactic mastectomy (CPM) is associated with improved survival, incidence of contralateral breast cancer (CBC), and recurrence in patients with unilateral breast cancer (UBC).
BACKGROUND
Despite conflicting data, CPM rates continue to increase. Here we present the first meta-analysis to assess post-CPM outcomes in women with UBC.
METHODS
We searched 5 databases and retrieved papers' bibliographies for relevant studies published through March 2012. Fixed- and random-effects meta-analyses were conducted on the basis of tests of study heterogeneity. We examined potential confounding via stratification and meta-regression. We report pooled relative risks (RRs) and risk differences (RDs) with 95% confidence intervals (CIs) at 2-tailed P < 0.05 significance.
RESULTS
Of 93 studies reviewed, 14 were included in meta-analyses. Compared with nonrecipients, CPM recipients had higher rates of overall survival [OS; RR = 1.09 (95% CI: 1.06, 1.11)] and lower rates of breast cancer-specific mortality [BCM; RR = 0.69 (95% CI: 0.56, 0.85)] but saw no absolute reduction in risk of metachronous CBC (MCBC). Among patients with elevated familial/genetic risk (FGR, ie, BRCA carrier status and/or family history of breast cancer), both relative and absolute risks of MCBC were significantly decreased among CPM recipients [RR = 0.04 (95% CI: 0.02, 0.09); RD = -24.0% (95% CI: -35.6%, -12.4%)], but there was no improvement in OS or BCM.
CONCLUSIONS
CPM is associated with decreased MCBC incidence but not improved survival among patients with elevated FGR. The superior outcomes observed when comparing CPM recipients with nonrecipients in the general population are likely not attributable to a CPM-derived decrease in MCBC incidence. UBC patients without known FGR should not be advised to undergo CPM.
Topics: Breast Neoplasms; Female; Global Health; Humans; Incidence; Mastectomy; Neoplasm Recurrence, Local; Risk Factors
PubMed: 24950272
DOI: 10.1097/SLA.0000000000000769 -
The British Journal of Surgery Nov 2020The growing volume of studies of robot-assisted nipple-sparing mastectomy requires critical assessment. This review synthesizes the data on safety, feasibility,...
BACKGROUND
The growing volume of studies of robot-assisted nipple-sparing mastectomy requires critical assessment. This review synthesizes the data on safety, feasibility, oncological and cosmetic outcomes, and patient-reported outcome measures (PROMs) for robot-assisted nipple-sparing mastectomy.
METHODS
A systematic review was performed using MEDLINE, MEDLINE In-Process/ePubs, Embase/Embase Classic, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, LILACS, PubMed, ClinicalTrials.Gov, WHO ICTRP and the grey literature. Original studies reporting on patients with breast cancer or at increased risk of breast cancer undergoing robot-assisted nipple-sparing mastectomy were included. Risk of bias was assessed using the Institute of Health Economics Case Series Quality Appraisal Checklist.
RESULTS
Of 7177 titles screened, eight articles were included, reporting on 249 robot-assisted nipple-sparing mastectomies in 187 women. The indication was either therapeutic (58·6 per cent) or prophylactic (41·4 per cent), with immediate reconstruction performed in 96·8 per cent. Surgical techniques followed a similar approach, with variations in incision, robot models, camera and insufflation. Postoperative morbidity included skin complications, lymphocele, infection, seroma, haematoma and skin ischaemia/necrosis. Complications specific to the nipple-areolar complex included ischaemia and necrosis. There were two conversions owing to haemorrhage, but no intraoperative deaths. Three patients had positive margins. Follow-up time ranged from 3·4 to 44·8 months. Locoregional recurrences were not observed. PROMs and objective cosmetic outcomes were reported inconsistently. Data on nipple sensitivity were not reported.
CONCLUSION
Robot-assisted nipple-sparing mastectomy is feasible with acceptable short-term outcomes but it remains in the assessment phase.
Topics: Female; Humans; Mastectomy; Nipples; Patient Reported Outcome Measures; Robotic Surgical Procedures
PubMed: 32846014
DOI: 10.1002/bjs.11837 -
Breast (Edinburgh, Scotland) Aug 2016Conduct a systematic review of quantitative and qualitative studies exploring patient reported factors and psychological variables influencing the decision to have... (Review)
Review
OBJECTIVE
Conduct a systematic review of quantitative and qualitative studies exploring patient reported factors and psychological variables influencing the decision to have contralateral prophylactic mastectomy (CPM), and satisfaction with CPM, in women with early stage breast cancer.
METHODS
Studies were identified via databases: Medline, CINAHL, Embase and PsycINFO. Data were extracted by one author and crosschecked by two additional authors for accuracy. The quality of included articles was assessed using standardised criteria by three authors.
RESULTS
Of the 1346 unique citations identified, 17 were studies that met the inclusion criteria. Studies included were primarily cross-sectional and retrospective. No study utilised a theoretical framework to guide research and few studies considered psychological predictors of CPM. Fear of breast cancer was the most commonly cited reason for CPM, followed by cosmetic reasons such as desire for symmetry. Overall, women appeared satisfied with CPM, however, adverse/diminished body image, poor cosmetic result, complications, diminished sense of sexuality, emotional issues and perceived lack of education regarding alternative surveillance/CPM efficacy were cited as reasons for dissatisfaction.
CONCLUSION
Current literature has begun to identify patient-reported reasons for CPM; however, the relative importance of different factors and how these factors relate to the process underlying the decision to have CPM are unknown. Of women who considered CPM, limited information is available regarding differences between those who proceed with or ultimately decline CPM.
Topics: Body Image; Breast Neoplasms; Choice Behavior; Emotions; Fear; Female; Humans; Patient Education as Topic; Patient Satisfaction; Prophylactic Mastectomy; Sexuality
PubMed: 27290619
DOI: 10.1016/j.breast.2016.04.005 -
Journal of Plastic, Reconstructive &... Dec 2014There are many known breast cancer risk factors, but traditionally the list has not included breast size. The aim of this study was to synthesize the literature on... (Review)
Review
BACKGROUND
There are many known breast cancer risk factors, but traditionally the list has not included breast size. The aim of this study was to synthesize the literature on breast size as a risk factor for breast carcinoma by examining studies addressing this question both directly and indirectly.
METHODS
A systematic review was performed searching MEDLINE from 1950 to November 2010, and updated again in February 2014. Literature was sought to assess the relationship between the following variables and breast cancer: 1) breast size; 2) breast reduction; 3) breast augmentation; and 4) prophylactic subcutaneous mastectomy. Findings were summarized and the levels of evidence were assessed.
RESULTS
50 papers were included in the systematic review. Increasing breast size appears to be a risk factor for breast cancer, but studies are limited by their retrospective nature, imperfect size measurement techniques and confounding variables. The evidence is stronger for risk reduction with breast reduction, including prophylactic subcutaneous mastectomy at the extreme. Generally the breast augmentation population has a lower risk of breast cancer than the general population, but it is unclear whether or not this is related to the bias of small breasts in this patient population and the presence of other confounders.
CONCLUSIONS
There is direct and indirect evidence that breast size is an important factor in the risk of developing breast cancer. Plastic surgeons are in a unique position to observe this effect. Well-designed prospective studies are required to further assess this risk factor.
Topics: Breast; Breast Neoplasms; Female; Humans; Mammaplasty; Mastectomy, Subcutaneous; Organ Size; Risk Factors
PubMed: 25456291
DOI: 10.1016/j.bjps.2014.10.001 -
Sexual Medicine Reviews Dec 2023Preventative surgical procedures for patients who are breast cancer (BRCA) positive-namely, bilateral salpingo-oophorectomy and mastectomy-have been linked to changes in...
Prophylactic mastectomy and bilateral salpingo-oophorectomy in patients with breast cancer: a systematic review of postsurgical sexual function and menopausal hormone therapy symptom mitigation.
INTRODUCTION
Preventative surgical procedures for patients who are breast cancer (BRCA) positive-namely, bilateral salpingo-oophorectomy and mastectomy-have been linked to changes in sexual function, including surgically induced menopause. A patient's decision to undergo preventive surgery as opposed to high-risk screening is heavily reliant on advice received from one's health care provider. Quality of life should be considered when shared decision making is conducted with patients.
OBJECTIVES
To assemble and analyze findings related to patient-reported sexual function after these surgical procedures, to see if and how either procedure affects sexual function from patient baseline, and to determine whether the effects can be mitigated with menopausal hormone therapy.
METHODS
A literature review based on the PubMed, Embase, and MEDLINE databases was conducted from inception through January 25, 2022. To be included, studies had to meet an a priori list of Medical Subject Headings: "BRCA" AND "sexual dysfunction" OR "dyspareunia." GRADE criteria were used to determine the quality of studies relating to menopause hormone therapy.
RESULTS
The search yielded 14 results, and 11 reported sufficient data for systematic review. Sexual function was measured via validated and investigator-generated surveys. All studies, no matter the survey metric, found significant reduction in sexual function with bilateral salpingo-oophorectomy; no studies revealed sexual function changes associated with mastectomy postsurgery. Few studies indicated that menopause hormone therapy resulted in significant improvement in sexual function, and all studies reported that postoperative sexual function could not reach baseline levels with therapy. No studies were high quality by GRADE metrics.
CONCLUSION
Prophylactic mastectomies and bilateral salpingo-oophorectomies among patients who are BRCA positive cause SF changes postprocedure. Menopausal hormone therapy offers little help in mediating symptoms. Significantly more research is needed to explore potential changes in sexual function, as it is an important aspect of quality of life for patients with BRCA positivity.
Topics: Female; Humans; Salpingo-oophorectomy; Breast Neoplasms; Prophylactic Mastectomy; Mastectomy; Quality of Life; Genes, BRCA2; Hormone Replacement Therapy; Menopause
PubMed: 37183167
DOI: 10.1093/sxmrev/qead020 -
Annals of Plastic Surgery Jul 2022Improving patient care and safety requires high-quality evidence. The objective of this study was to systematically review the existing evidence for patient safety (PS)...
BACKGROUND
Improving patient care and safety requires high-quality evidence. The objective of this study was to systematically review the existing evidence for patient safety (PS) and quality improvement initiatives in breast reconstruction.
METHODS
A systematic review of the published plastic surgery literature was undertaken using a computerized search and following PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Publication descriptors, methodological details, and results were extracted. Articles were assessed for methodological quality and clinical heterogeneity. Descriptive statistics were completed, and a meta-analysis was considered.
RESULTS
Forty-six studies were included. Most studies were retrospective (52.2%) and from the third level of evidence (60.9%). Overall, the scientific quality was moderate, with randomized controlled trials generally being higher quality. Studies investigating approaches to reduce seroma (28.3% of included articles) suggested a potential benefit of quilting sutures. Studies focusing on infection (26.1%) demonstrated potential benefits to prophylactic antibiotics and drain use under 21 days. Enhanced recovery after surgery protocols (10.9%) overall did not compromise PS and was beneficial in reducing opioid use and length of stay. Interventions to increase flap survival (10.9%) demonstrated a potential benefit of nitroglycerin on mastectomy skin flaps.
CONCLUSIONS
Overall, studies were of moderate quality and investigated several worthwhile interventions. More validated, standardized outcome measures are required, and studies focusing on interventions to reduce thromboembolic events and bleeding risk could further improve PS.
Topics: Breast Neoplasms; Female; Humans; Mammaplasty; Mastectomy; Patient Safety; Quality Improvement; Retrospective Studies
PubMed: 35749815
DOI: 10.1097/SAP.0000000000003062 -
American Journal of Surgery Oct 2016Mutations in BRCA1 or BRCA2 genes results in an elevated risk for developing both breast and ovarian cancers over the lifetime of affected carriers. General surgeons may... (Review)
Review
BACKGROUND
Mutations in BRCA1 or BRCA2 genes results in an elevated risk for developing both breast and ovarian cancers over the lifetime of affected carriers. General surgeons may be faced with questions about surgical risk reduction and survival benefit of prophylactic surgery.
METHODS
A systematic literature review was performed using the electronic databases PubMed, OVID MEDLINE, and Scopus comparing prophylactic surgery vs observation with respect to breast and ovarian cancer risk reduction and mortality in BRCA mutation carriers.
RESULTS
Bilateral risk-reducing mastectomy provides a 90% to 95% risk reduction in BRCA mutation carriers, although the data do not demonstrate improved mortality. The reduction in ovarian and breast cancer risks using risk-reducing bilateral salpingo-oophorectomy has translated to improvement in survival.
CONCLUSIONS
Clinical management of patients at increased risk for breast cancer requires consideration of risk, patient preference, and quality of life.
Topics: Breast Neoplasms; Female; Genes, BRCA1; Genes, BRCA2; Heterozygote; Humans; Mutation; Ovarian Neoplasms; Ovariectomy; Prophylactic Mastectomy; Prophylactic Surgical Procedures; Salpingectomy
PubMed: 27649974
DOI: 10.1016/j.amjsurg.2016.06.010