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- Chesnut, G. T., et al.
(författare)
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Patient-reported pain, discomfort, and anxiety during magnetic resonance imaging-targeted prostate biopsy
- 2020
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Ingår i: Canadian Urological Association Journal. - 1920-1214. ; 14:5
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Tidskriftsartikel (refereegranskat)abstract
- Introduction: The addition of targeted prostate biopsy to systemic biopsy impacts patient experience. We examined patient-reported pain, discomfort, anxiety, and tolerability among men undergoing magnetic resonance imaging (MRI)-targeted prostate biopsy in addition to transrectal ultrasound-guided systematic biopsy compared to those undergoing systematic biopsy alone. Methods: All patients underwent transrectal systematic 14-core biopsies. Patients with regions of interest on MRI underwent additional targeted biopsies. All patients received equivalent periprostatic nerve block. Four single-item, standard 11-point numerical rating scales evaluating pain, discomfort, anxiety, and tolerability were completed immediately after biopsy. Differences in means were compared using t-tests. Correlation between rated domains was tested using Spearman's correlation coefficient. Results: Of 273 consecutive patients, 195 (71%) underwent targeted biopsy and 188 (69%) had undergone prior biopsy. In all men, the median score for pain and tolerability was 3, while the median score for discomfort and anxiety was 4. Pain was rated at 7 or above by 15% of patients. Moderate correlation between pain, discomfort, anxiety, and tolerability of repeat biopsy was observed (Spearman's ρ between 0.48 and 0.76). Compared to patients undergoing systematic biopsy alone, men who received both targeted and systematic biopsies reported higher anxiety scores (difference 1.2; 95% confidence interval [CI] 0.4-2.0; p=0.004) and discomfort (difference 1.0; 95% CI 0.3-1.7; p<0.001). Conclusions: Patients undergoing targeted and systematic biopsies report more discomfort and anxiety than patients undergoing systematic biopsies alone. Absolute differences are small, and patients are willing to undergo repeat biopsy if advised. Interventions to reduce biopsy-related anxiety are needed. © 2020 Canadian Urological Association. All rights reserved.
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- Lonergan, Peter E., et al.
(författare)
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Prospective validation of microseminoprotein-β added to the 4Kscore in predicting high-grade prostate cancer in an international multicentre cohort
- 2021
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Ingår i: BJU International. - : Wiley. - 1464-4096 .- 1464-410X. ; 128:2, s. 218-224
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Tidskriftsartikel (refereegranskat)abstract
- Objectives: To prospectively evaluate the performance of a pre-specified statistical model based on four kallikrein markers in blood (total prostate-specific antigen [PSA], free PSA, intact PSA, and human kallikrein-related peptidase 2), commercially available as the 4Kscore, in predicting Gleason Grade Group (GG) ≥2 prostate cancer at biopsy in an international multicentre study at three academic medical centres, and whether microseminoprotein-β (MSP) adds predictive value. Patients and Methods: A total of 984 men were prospectively enrolled at three academic centres. The primary outcome was GG ≥2 on prostate biopsy. Three pre-specified statistical models were used: a base model including PSA, age, digital rectal examination and prior negative biopsy; a model that added free PSA to the base model; and the 4Kscore. Results: A total of 947 men were included in the final analysis and 273 (29%) had GG ≥2 on prostate biopsy. The base model area under the receiver operating characteristic curve of 0.775 increased to 0.802 with the addition of free PSA, and to 0.824 for the 4Kscore. Adding MSP to the 4Kscore model yielded an increase (0.014–0.019) in discrimination. In decision-curve analysis of clinical utility, the 4Kscore showed a benefit starting at a 7.5% threshold. Conclusion: A prospective multicentre evaluation of a pre-specified model based on four kallikrein markers (4Kscore) with the addition of MSP improves the predictive discrimination for GG ≥2 prostate cancer on biopsy and could be used to inform biopsy decision-making.
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- Vickers, A. J., et al.
(författare)
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A randomized comparison of two-stage versus traditional one-stage consent for a low-stakes randomized trial
- 2023
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Ingår i: Clinical Trials. - 1740-7745. ; 20:6, s. 642-648
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Tidskriftsartikel (refereegranskat)abstract
- Background/Aims It has been proposed that informed consent for randomized trials should be split into two stages, with the purported advantage of decreased information overload and patient anxiety. We compared patient understanding, anxiety and decisional quality between two-stage and traditional one-stage consent. Methods We approached patients at an academic cancer center for a low-stakes trial of a mind-body intervention for procedural distress during prostate biopsy. Patients were randomized to hear about the trial by either one- or two-stage consent (n = 66 vs n = 59). Patient-reported outcomes included Quality of Informed Consent (0-100); general and consent-specific anxiety and decisional conflict, burden, and regret. Results Quality of Informed Consent scores were non-significantly superior for two-stage consent, by 0.9 points (95% confidence interval = -2.3, 4.2, p = 0.6) for objective and 1.1 points (95% CI = -4.8, 7.0, p = 0.7) for subjective understanding. Differences between groups for anxiety and decisional outcomes were similarly small. In a post hoc analysis, consent-related anxiety was lower among two-stage control patients, likely because scores were measured close to the time of biopsy in the two-stage patients receiving the experimental intervention. Conclusion Two-stage consent maintains patient understanding of randomized trials, with some evidence of lowered patient anxiety. Further research is warranted on two-stage consent in higher-stakes settings.
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- Vickers, A. J., et al.
(författare)
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Patient accrual and understanding of informed consent in a two-stage consent design
- 2021
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Ingår i: Clinical Trials. - : SAGE Publications. - 1740-7745 .- 1740-7753. ; 18:3, s. 377-382
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Tidskriftsartikel (refereegranskat)abstract
- Background: We previously introduced the concept of "two-stage" (or "just-in-time") informed consent for randomized trials with usual care control. We argued that conducting consent in two stages-splitting information about research procedures from information about the experimental intervention-would reduce the decisional anxiety, confusion, and information overload commonly associated with informed consent. We implemented two-stage consent in a low-stakes randomized trial of a mindfulness meditation intervention for procedural distress in patients undergoing prostate biopsy. Here, we report accrual rates and patient understanding of the consent process. Methods: Patients approached for consent for the biopsy trial were asked to complete the standard "Quality of Informed Consent" questionnaire to assess their knowledge and understanding of the trial. Results: Accrual was excellent with 108 of 110 (98%) patients approached for consent signing first-stage consent. All 51 patients randomized to the experimental arm and who later presented for biopsy signed second-stage consent and received the mindfulness intervention. Quality of Informed Consent data were available for 48 patients assigned to the mindfulness treatment arm and 44 controls. The mean Quality of Informed Consent score was similar in the meditation and control arms with and overall mean of 75 (95% confidence interval = 74-76) for the knowledge section and 86 (95% confidence interval = 81-90) for understanding, comparable to the normative scores of 80 and 88. On further analysis and patient interview, two of the Quality of Informed Consent questions were found to be misleading in the context of a two-stage consent study for a mindfulness intervention. Excluding these questions increased knowledge scores to 88 (95% confidence interval = 87-90). Conclusion: We found promising data that two-stage consent facilitated accrual without compromising patient understanding of randomized trials or compliance with allocated treatment. Further research is needed incorporating randomized comparison of two-stage consent to standard consent approaches, measuring patient anxiety and distress as an outcome, using suitable modifications to the Quality of Informed Consent questionnaire and trials with higher stakes.
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- Vickers, Andrew, et al.
(författare)
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Properties of the 4-Kallikrein Panel Outside the Diagnostic Gray Zone : Meta-Analysis of Patients with Positive Digital Rectal Examination or Prostate Specific Antigen 10 ng/ml and Above
- 2017
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Ingår i: Journal of Urology. - : Ovid Technologies (Wolters Kluwer Health). - 0022-5347 .- 1527-3792. ; 197, s. 607-613
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Tidskriftsartikel (refereegranskat)abstract
- Purpose: The 4-kallikrein panel, commercially available as the 4Kscore™, is a reflex test for prostate cancer early detection that has been extensively validated in multiple international cohorts. It has been suggested that use of such reflex tests be limited to those with prostate specific antigen less than 10 ng/ml and negative digital rectal examination. We aimed to determine the value of the panel in men outside this "diagnostic gray zone.". Materials and Methods: We performed an individual patient data meta-analysis using data from prior studies on the 4-kallikrein panel. We calculated the properties of the panel for predicting high grade (Gleason 7+) cancer in a subgroup of men with either positive digital rectal examination or prostate specific antigen 10 to 25 ng/ml. Results: A total 2,891 men from 8 cohorts were included. An important proportion of patients, including 32% in the United States validation study, had prostate specific antigen 10 to 25 ng/ml or a positive digital rectal examination. For men with prostate specific antigen 10 to 25 ng/ml the fixed-effects estimate for the discrimination of the kallikrein model was 0.84 vs 0.69 for the base model (difference 0.128, 95% CI 0.098-0.159). In the positive digital rectal examination group discrimination was 0.82 vs 0.72 (difference 0.092, 95% CI 0.069-0.115). Decision analysis showed a clinical net benefit for use of the panel in this subgroup with a reduction in biopsy rates of about 20% and only a small number of high grade cancers missed, fewer than 3% of those not biopsied. Conclusion: The use of the kallikrein panel in men with a positive digital rectal examination or prostate specific antigen 10 to 25 ng/ml is justified.
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