Pain in Men Undergoing Transperineal Free-Hand Multiparametric Magnetic Resonance Imaging Fusion Targeted Biopsies under Local Anesthesia: Outcomes and Predictors from a Multicenter Study of 1,008 Patients.

PURPOSE: Several transperineal biopsy series have proven feasibility under local anesthesia. However, there is a lack of large analyses detailing pain outcomes and factors influencing pain. MATERIALS AND METHODS: From 2016 to 2019 we performed a multicenter prospective study in men undergoing multiparametric magnetic resonance imaging-transperineal fusion biopsies (target+systematic cores) under local anesthesia. Primary outcomes were 1) pain scores (assessed through a 0 to 10-point numeric rating scale) and 2) identification of factors associated with severe pain. The secondary outcome was to evaluate pain influence on clinically significant prostate cancer target cores detection. RESULTS: We included 1,008 men undergoing transperineal fusion biopsies under local anesthesia. Mean±SD numeric rating scale pain scores were 3.9±2.1 at local anesthesia administration and 3.1±2.3 when performing biopsies. Pain was not associated with lower clinically significant prostate cancer detection on targeted cores (p=0.23 and p=0.47 depending on clinically significant prostate cancer definition). On multivariate analysis age (OR 0.96, 95% CI 0.94-0.99) and severe anxiety (OR 2.99, 95% CI 1.83-4.89) were a protective and risk factor, respectively, for severe biopsy pain. Procedural time was also associated with an increased risk of experiencing severe biopsy pain (OR 1.04, 95% CI 1.00-1.08). If aiming to test the possible effects of anxiety preventive measures on pain, an anxiety cutoff greater than 6 on a numeric rating scale would decrease to 13% the number of patients being treated while identifying 56% of those experiencing severe pain. CONCLUSIONS: Transperineal fusion biopsies under local anesthesia result in moderate pain. Pain does not influence clinically significant prostate cancer target detection. Patient anxiety predicts pain. A numeric rating scale based anxiety assessment may be used to identify those at higher risk for experiencing severe pain in men undergoing transperineal fusion biopsies.

Breast Cancer and COVID-19: The Effect of Fear on Patients' Decision-making Process.

BACKGROUND/AIM: Coronavirus-19 (COVID-19) pandemic outbreak is currently having a huge impact on medical resource allocation. Breast Cancer (BC) patients are concerned both with BC treatment and COVID-19. This study aimed to estimate the impact of anxiety among patients, caused by the spreading of COVID-19. PATIENTS AND METHODS: Between the 16th of January and the 20th of March 2020, we retrospectively enrolled 160 patients. Eighty-two patients with a suspected breast lesion (SBL) were divided into two groups: PRE-COVID-19-SBL and POST-COVID-19-SBL. Seventy-eight BC patients were divided into PRE-COVID-19-BC and POST-COVID-19-BC. Patient characteristics including age, marital status, SBL/BC diameter, personal and family history of BC, clinical stage and molecular subtype were recorded. Procedure Refusal (PR) and Surgical Refusal (SR) were also recorded with their reason. RESULTS: BC and SBL analysis showed no difference in pre-treatment characteristics (p>0.05). Both POST-COVID-19-SBL and POST-COVID-19-BC groups showed higher rates of PR and SR (p=0.0208, p=0.0065 respectively). Infection risk represented primary reason for refusal among POST-COVID-19 patients. CONCLUSION: COVID-19-related anxiety could affect patients' decision-making process.

Role of cytotechnologists in rapid onsite adequacy assessment of cytology materials for diagnostic workup and specimen allocation for ancillary testing using a standardized protocol.

INTRODUCTION: Data on the performance of cytotechnologists in assessing specimen adequacy of needle core biopsies (NCB) is scant and their role in specimen triaging for ancillary studies have not been well established. MATERIALS AND METHODS: We retrospectively analyzed rapid onsite evaluation (ROSE) performed exclusively by cytotechnologists on 248 NCB and fine-needle aspiration (FNA) specimens. Overall adequacy and accuracy rates were determined by comparing to final diagnosis. We also reviewed the process of specimen allocation for ancillary testing to determine whether specimens were appropriately triaged at the time of ROSE. RESULTS: Of the 248 cases, 222 (89.5%) were touch imprint and 26 (10.5%) were FNA smears. The overall adequacy rate was 73.4% (182 of 248). Concordance for "adequate" interpretation by ROSE with unequivocal malignant or benign diagnoses on final interpretation was 95.6%. The sensitivity, specificity, and accuracy of ROSE for a final "positive for malignancy" were 89.2% (95% CI 83.04% to 93.69%), 43.24% (95% CI 31.77% to 55.28%), and 73.87% (95% CI 67.57% to 55.28%), respectively. Cases with "positive for malignancy" on final diagnosis were "adequate" by ROSE in 89.1% (132 of 148) and "inadequate" in 10.8% (16 of 148), P < 0.0001. Ancillary tests were performed in 168 of 248 (67.7%); the majority were immunohistochemical stains for determining tumor subtype. Predictive biomarkers were performed successfully in 100% of metastatic breast cancers. CONCLUSIONS: Cytotechnologists performed at a high level of competency in providing ROSE and allocating specimens for ancillary testing, which were performed successfully in the majority of cases. Implementation of a standardized protocol for tissue management/prioritization is of paramount importance to maximize tissue preservation and minimize wastage.

A Randomized Controlled Trial of Brief Mindfulness Meditation for Women Undergoing Stereotactic Breast Biopsy.

PURPOSE: Stereotactic breast biopsy (SBB) is a common, anxiety-producing procedure. Nonpharmacologic methods to manage acute anxiety are needed. METHODS: In this single-blind trial, women were recruited before SBB and randomized in a 2:2:1 ratio to a single session of guided mindfulness-based meditation (GM; n = 30), focused breathing (FB; n = 30), or standard care (SC; n = 16). Anxiety and pain were assessed at baseline after a 10-min prebiopsy group-specific activity (GM, FB, or SC), every 4 min during SBB, and after biopsy. Electroencephalographic activity in the medial prefrontal cortex, insula, anterior cingulate cortex, and precuneus was collected throughout the study. RESULTS: Women in the GM group reported a steeper reduction in anxiety than women in the FB and SC groups (P < .001 for all, Cohen's d > 0.4 for all). There were no group differences in pain ratings during the biopsy. Women in the GM group experienced increased beta activity during biopsy in the insula (P = .006, Cohen's d = 1.4) and anterior cingulate cortex (P = .019, Cohen's d = 1.0) compared with women in the SC group, and there was a trend toward the same effect compared with women in the FB group (P < .10 for both). Women in the GM and FB groups experienced a nonsignificant decrease in delta activity in the precuneus during biopsy compared with those in the SC group (P < .40 for both, Cohen's d > 0.6 for both), which was associated with a steeper reduction in anxiety during the biopsy (r = 0.51, P < .01). CONCLUSIONS: Brief, guided meditation may provide effective anxiety relief during an acute medical procedure and affect neuronal activity in regions associated with attention, self-awareness, and emotion regulation.

The Association of Previous Prostate Biopsy Related Complications and the Type of Complication with Patient Compliance with Rebiopsy Scheme.

PURPOSE: Prostate biopsy complications have important consequences that may affect patient compliance with rebiopsy schemes. However, to our knowledge this has not been studied in earnest. Thus, we evaluated whether previous prostate biopsy related complications and the type of complication were associated with repeat prostate biopsy compliance in a clinical trial with study mandated systematic biopsies. MATERIALS AND METHODS: We retrospectively analyzed the records of 4,939 men 50 to 75 years old who underwent 2-year prostate biopsy and were recommended to undergo 4-year prostate rebiopsy in the REDUCE (Reduction by Dutasteride of Prostate Cancer Events) study. The analyzed biopsy complications were hematuria, urinary tract infection, acute urinary retention and hemospermia. RESULTS: A total of 260 men (5.3%) had a 2-year prostate biopsy related complication, including hematuria in 180 (3.6%), urinary tract infection in 36 (0.7%), acute urinary retention in 26 (0.5%) and hemospermia in 102 (2.1%). A total of 474 men (9.6%) were noncompliant with 4-year rebiopsy. On univariable analysis any previous complication (OR 1.56, 95% CI 1.08-2.24, p = 0.018), urinary tract infection (OR 2.72, 95% CI 1.23-6.00, p = 0.013), acute urinary retention (OR 4.24, 95% CI 1.83-9.81, p = 0.016) and hemospermia (OR 1.78, 95% CI 1.03-3.06, p = 0.037) were associated with rebiopsy noncompliance. Hematuria was not associated with rebiopsy noncompliance (OR 1.19, 95% CI 0.74-1.91, p = 0.483). Results were unchanged on multivariable analysis, including for any complication (OR 1.65, 95% CI 1.08-2.26, p = 0.018), for urinary tract infection (OR 2.62, 95% CI 1.07-3.21, p = 0.029), for acute urinary retention (OR 4.51, 95% CI 1.93-10.54, p = 0.001), for hemospermia (OR 1.85, 95% CI 1.07-3.21, p = 0.029) and for hematuria (OR 1.19, 95% CI 0.74-1.93, p = 0.472). CONCLUSIONS: In men who undergo repeat prostate biopsy a previous biopsy related complication and the type of complication were associated with lower compliance with rebiopsy schemes. Patients who experience biopsy related complications are ideal candidates to receive intervention regarding the importance of prostate rebiopsy to prevent noncompliance.

Comparing morbidities of testing with a new index: screening colonoscopy versus core-needle breast biopsy.

PURPOSE: Focusing on outcomes of care alone may be too restrictive. Patients can experience morbidity that is important to them from health care processes themselves. However, many processes, such as testing and screening, have been little evaluated. This study's purpose was to assess the construct validity of a new preference-based index, the Testing Morbidities Index (TMI), by comparing two common cancer-related procedures in prior publications: screening colonoscopy and core-needle breast biopsy. METHODS: Women evaluating their breast biopsies (n = 100) were compared with men and women who had undergone screening colonoscopy (n = 109) after both groups completed the TMI. The TMI addresses physical and mental or emotional quality of life affected by test-specific aspects occurring before, during, or after any test. It has 7 domains and survey items. TMI scores can be scaled in various ways, including multi-attribute value theory-based patient or societal preferences, where 0 = dead and 1.0 = full health, as used here. RESULTS: There was significantly greater morbidity from breast biopsy (mean, 0.84) than from screening colonoscopy (mean, 0.88) comparing overall TMI preference scores (P < .0001). Breast biopsy showed significantly worse morbidity (P = .005 to P < .0001) in most domains. Pain or discomfort before testing was worse for colonoscopy because of bowel preparation. The TMI showed no floor effect and an acceptable ceiling effect. CONCLUSIONS: The TMI provides the first objective evidence comparing the morbidity of one cancer-related testing procedure with another. The TMI may be useful in assessments of medical care processes informative to institutions and imaging departments, shared decision-making scenarios, and economic analyses.

Patient's comfort with and tolerability of thyroid core needle biopsy.

Recently, the core needle biopsy (CNB) has been proposed as a complementary test for thyroid nodules with inconclusive cytology by fine-needle aspiration (FNA). However, there have been no reports regarding patient comfort during and after CNB or tolerability of this procedure. Here we aimed to investigate and compare comfort with and tolerability of the CNB and FNA procedures. A 21 gauge needle was used for collection in CNB procedures, and a 23 gauge needle was used for collection in FNA procedures. Sixty-one consecutive patients underwent both biopsies and were asked to evaluate their comfort during and after these procedures by a structured questionnaire. A total of 58 (95 %) patients reported local pain during both biopsies. Two patients reported pain only during CNB, and one reported no pain. Mild pain was reported in 87 % of CNB cases. Local pain after biopsy was reported in 29 % of FNA and 45 % of CNB. The occurrence of pain in the first minutes following CNB was significantly higher than FNA (p = 0.008), while there was not a significant difference in pain at later time points after the procedures. Finally, patients were asked to evaluate the degree of tolerability of the two sampling techniques, and FNA and CNB were reported as tolerable in 82 and 83 %, respectively. The results from a questionnaire evaluating patients' comfort level showed no significant difference between the tolerability of CNB and FNA. This finding suggests that CNB may be performed with a reasonable level of patient comfort.

Patient attitudes towards undergoing additional breast biopsy for research.

BACKGROUND: Acquisition of additional breast tissue has become integral to breast oncology research. This questionnaire study examines patient willingness to undergo research-dedicated breast biopsies either at time of diagnostic biopsy (T1) or after carcinoma diagnosis has been confirmed and eligibility for a specific study established (T2), and influencing factors thereof. METHODS: Prior to consultation, patients attending breast clinics were recruited to complete a questionnaire examining willingness to undergo an extra fine needle aspirate (FNA) and/or core needle biopsy (CNB) for research either at T1 or T2. Descriptions of FNA and CNB procedures were supplied to those with no prior experience. Patient perspectives towards donating surplus tissue remaining from a diagnostic procedure and/or surgery for future research were also explored. FINDINGS: A total of 100 patients were recruited, 42% with prior history of breast carcinoma (BC), 22% with family history of BC (FHBC) and 65%/42% with previous experience of CNB/FNA respectively. Overall, 57% were willing to undergo additional biopsy at one or both time points. Willingness to undergo additional biopsy was greater for T1 than T2, but equivalent for CNB and FNA (willingness CNB T1, 50% vs T2, 26%, willingness FNA T1 50% vs T2 29%). A statistically significant increase in willingness to undergo CNB and/or FNA at T1 and/or T2 was seen in association with prior diagnosis of BC, FHBC, previous visit to breast clinic and prior experience of breast biopsy. 83% of patients expressed a willingness to allow surplus tissue to be stored in a biobank for future research. INTERPRETATION: Where possible patients should be approached to undergo baseline research biopsies at time of diagnostic process rather than subsequently. Patients do not find FNA more acceptable than core biopsy. Prior exposure to the biopsy procedure increases willingness to undergo research-dedicated biopsies.

A relaxation response training for women undergoing breast biopsy: exploring integrated care.

BACKGROUND: Recent changes in clinical guideline recommendations for age of breast cancer screening initiation highlighted the potential psychological ramifications associated with screening. This study examined the feasibility, acceptability, and preliminary efficacy of a brief Relaxation Response training (RRT) to decrease distress among women undergoing breast biopsy. METHODS: Women scheduled for percutaneous core-needle biopsy were recruited into a single-arm RRT trial, including 3 individual sessions. Psychosocial assessments were completed pre- and postintervention. RESULTS: Forty women were enrolled between 6/1/10 and 8/31/11. Among enrollees, 75% completed all 3 RRT sessions, and 75% completed the post-assessment. Participants showed significant reductions in acute distress following each RRT session. Qualitative feedback indicated a positive impact of RRT on clinic care experiences. CONCLUSIONS: RRT is a portable intervention that was feasible to implement, acceptable to patients and associated with significant decreases in acute emotional distress during the period of diagnostic uncertainty related to percutaneous breast biopsy.

Prostate cancer diagnosis is associated with an increased risk of erectile dysfunction after prostate biopsy.

OBJECTIVE: To evaluate prospectively the characteristics, erectile function and lower urinary tract symptoms (LUTS) of men undergoing prostate needle biopsy (PNBx). PATIENTS AND METHODS: From 2008 to 2011, 134 men were prospectively administered the International Index of Erectile Function (IIEF), American Urological Association Symptom Index (AUA-SI), and quality-of-life (QoL) questionnaires before and after undergoing a single 12-core PNBx. Comparisons of IIEF and AUA-SI scores before and after PNBx, based upon baseline characteristics and prostate cancer (PCa) diagnosis, were performed. Univariable and multivariable logistic regression models were used to characterize predictors of change in IIEF scores. RESULTS: In the 85 men who fulfilled the inclusion criteria, there were no significant differences between the mean (sd) total pre-biopsy and the mean (sd) post-biopsy IIEF scores: 57.8 (12.9) vs 54.3 (17.2). Subgroup analysis showed that men who had biopsy-proven PCa had significantly greater changes in their post-biopsy IIEF scores compared with men without (-10.1 vs. 1.0; P < 0.001). After specific analyses of the IIEF domains in these groups we found significant decreases in every domain, including erectile function (P = 0.01). On multivariate analyses, only PCa diagnosis was associated with a significant change in IIEF (odds ratio 7.2; P = 0.003). There were no differences in AUA-SI or QoL scores in the overall population or in subgroups. CONCLUSIONS: Cancer diagnosis appears to have an adverse effect on the erectile function of men undergoing PNBx but no effect on LUTS. This study highlights a potential negative psychological confounder that may influence erectile function before the treatment of PCa. Additional prospective trials evaluating these relationships are warranted.