Prospective Multicenter Evaluation Research Articles

Response to Comment on Beato-Víbora et al. A Multicenter Prospective Evaluation of the Benefits of Two Advanced Hybrid Closed-Loop Systems in Glucose Control and Patient-Reported Outcomes in a Real-world Setting. Diabetes Care 2024;47:216-224.

Response to Comment on Beato-Víbora et al. A Multicenter Prospective Evaluation of the Benefits of Two Advanced Hybrid Closed-Loop Systems in Glucose Control and Patient-Reported Outcomes in a Real-world Setting. Diabetes Care 2024;47:216-224.

Comment on Beato-Víbora et al. A Multicenter Prospective Evaluation of the Benefits of Two Advanced Hybrid Closed-Loop Systems in Glucose Control and Patient-Reported Outcomes in a Real-World Setting. Diabetes Care 2024;47:216-224.

Comment on Beato-Víbora et al. A Multicenter Prospective Evaluation of the Benefits of Two Advanced Hybrid Closed-Loop Systems in Glucose Control and Patient-Reported Outcomes in a Real-World Setting. Diabetes Care 2024;47:216-224.

Reply: Prospective Multicenter Evaluation of Pain Before and After Removal of Nonobstructing Renal Calculi: A CoRE Initiative.

Reply: Prospective Multicenter Evaluation of Pain Before and After Removal of Nonobstructing Renal Calculi: A CoRE Initiative.

Prospective multicenter evaluation of adherence to the Dutch guideline for children aged 0-16years with fever without a source-febrile illness in children (FINCH) study.

We found a high non-adherence rate of 48%, which did not lead to unfavorable clinical outcomes. This substantiates the need for a critical reevaluation of the FWS guideline and its indications for bacterial cultures, viral testing, and antibiotic treatment. • Despite the development of national guidelines, variation in practice is still substantial in the assessment of febrile children to distinguish severe infection from mild self-limiting disease. • Previous retrospective research suggests low adherence to national guidelines for febrile children in practice. • In case of non-adherence to the Dutch national guideline, similar to the National Institute for Health and Care Excellence (NICE) guideline from the United Kingdom, physicians have used fewer resources than the guideline recommended without increasing missed severe infections.

Multi-centre prospective evaluation of cognitive function in patients with metastatic castrate-resistant prostate cancer (mCRPC) treated with abiraterone acetate (AA) or enzalutamide (ENZ): The ACE study.

20 Background: AA and ENZ are both approved for the treatment of mCRPC. Understanding the early impact of these treatments on various domains of cognitive function, depression and fatigue would lead to optimisation of treatment selection and promote supportive care planning in this patient group. Methods: The study was conducted at 12 UK centres to assess the impact of AA or ENZ on cognitive function and fatigue in mCRPC patients. Cognition was assessed using the CANTAB assessment tool at baseline prior to initiation of AA or ENZ and then at 3, 4 and 6 months. Patient reported outcomes (PROs) were also collected at these timepoints using the FACT-Cog, FACT-F and PH9-Q questionnaires. Results: Data from 253 patients at baseline (141 AA; 112 ENZ), were analysed with a median age 74 (52-92). Previous docetaxel had been received by 49% of patients. Sample size at 3-months was 184 (95 AA; 89 ENZ) and was 131 at 6-months (67 AA; 64 ENZ). After controlling for baseline, there was no difference between AA and ENZ in mean composite cognitive outcome (3-months p = .553, 6-months p = .198) or in the individual components for Spatial Working Memory, Rapid Information Processing, or Spatial Information Processing. However, the Reaction Time Task difference was significant at 3-months (p=.009) and 6 months (p = .037). The ANCOVA suggests that at 6-months the gap between ENZ and AA has significantly widened and this is due to marginally poorer performance in ENZ and marginally improved performance in AA. When comparing individual components of the PROs such as the mean fatigue changes (FACT-F scale) between baseline and each timepoint, there was significant deterioration in the ENZ (p < .001) but not the AA group, with a statistically significant difference in mean fatigue between AA and ENZ at 3-months (p < .001), and at 6-months (p < .001). Mean PHQ-9 score (for depression) showed increased levels of depression in both groups, but with outcomes significantly poorer in ENZ at 3-months (p = .022) and 6-months (p = .020) compared to AA. Mean PCA (Perceived cognitive ability) and CFO (comments from others) was significantly poorer in ENZ at 3-months (p <.001) and at 6-months (p <.001) with no significant difference between groups in (PCI) perceived cognitive impairment. Conclusions: This study shows that whilst composite cognitive outcome is comparable in mCRPC patients treated with AA or ENZ at 3 and 6 months, patients on ENZ report more fatigue, depression and deterioration in perceived cognitive ability and have a slower reaction time when compared to AA. This is an important consideration for treatment optimisation and ensuring supportive strategies for the patients when using these drugs keeping in perspective the cognitive function assessment at baseline and subsequently on treatment.

Study protocol of a national multicentre prospective evaluation study assessing the validity and impact of the Dutch Paediatric Early Warning Score (PEWS) in the Netherlands

IntroductionEarly recognition of clinical deterioration and timely intervention are important to improve morbidity and mortality in paediatric care. The Paediatric Early Warning Score (PEWS) is a scoring system aiming to...

Skull Base Repair following Resection of Vestibular Schwannoma: A Systematic Review (Part 1: The Retrosigmoid Approach)

Abstract Objective Despite advances in skull-base reconstruction techniques, cerebrospinal fluid (CSF) leaks remain a common complication following retrosigmoid (RS) vestibular schwannoma (VS) surgery. We aimed to review and classify the available strategies used to prevent CSF leaks following RS VS surgery. Methods A systematic review, including studies of adults undergoing RS VS surgery since 2000, was conducted. Repair protocols were synthesized into a narrative summary, and a taxonomic classification of techniques and materials was produced. Additionally, the advantages, disadvantages, and associated CSF leak rates of different repair protocols were described. Results All 42 studies were case series, of which 34 were retrospective, and eight were prospective. Repair strategies included heterogeneous combinations of autografts, xenografts, and synthetic materials. A repair taxonomy was produced considering seven distinct stages to CSF leak prevention, including intraoperative approaches to the dura, internal auditory canal (IAC), air cells, RS bony defect, extracranial soft tissue, postoperative dressings, and CSF diversion. Notably, there was significant heterogeneity among institutions, particularly in the dural and IAC stages. The median postoperative incidence of CSF leaks was 6.3% (IQR: 1.3–8.44%). Conclusions The intraoperative strategies used to prevent CSF leaks during RS VS surgery vary between and within institutions. As a result of this heterogeneity and inconsistent reporting of CSF leak predictive factors, a meaningful comparative analysis of repair protocols was not feasible. Instead, we propose the development of a prospective multicenter observational evaluation designed to accurately capture a comprehensive dataset of potential CSF risk factors, including all stages of the operative repair protocol.

A multicentre Prospective evaluation of Patient Related Outcome Measures (PROMS) and Health Related Quality of Life (HRQoL) in Patients with Resectable Pancreatic and Peripancreatic Cancer (PROMCAN Study)

A multicentre Prospective evaluation of Patient Related Outcome Measures (PROMS) and Health Related Quality of Life (HRQoL) in Patients with Resectable Pancreatic and Peripancreatic Cancer (PROMCAN Study)

Prospective Multicenter Evaluation of Pain Before and After Removal of Nonobstructing Renal Calculi: A CoRE Initiative.

Flank pain associated with stone disease is typically caused by a stone that obstructs urine flow. However, it is plausible that nonobstructing kidney stones may still cause pain. We performed a multicenter, observational trial to evaluate whether treatment of small nonobstructing calyceal stones improves pain and kidney stone-specific health-related quality of life. Patients aged 18 years or older with nonobstructing renal stone(s) up to 10 mm in longest diameter and moderate to severe pain were recruited. All participants completed 3 questionnaires: the Brief Pain Inventory (BPI), the Patient-Reported Outcomes Measurement Information System pain interference form 6a, and the Wisconsin Stone Quality of Life questionnaire. Thereafter, all participants underwent ureteroscopy for renal stone treatment. All 3 questionnaires were repeated at 2, 6 to 8, and at 12 weeks postprocedure. The primary outcomes were change in preoperative to 12-week postoperative mean BPI score and worst BPI pain score. A total of 43 patients with nonobstructing kidney stones and associated flank pain were recruited. All stones were removed. Preoperatively, BPI scores for mean pain and worst pain were 5.5 and 7.2, respectively which decreased to 1.8 and 2.8 respectively at 12 weeks postoperatively. Wisconsin Stone Quality of Life questionnaire mean score increased from 70.4 to 115.3 at 12 weeks postoperatively. A total of 86% and 69% of patients had at least a 20% and 50% reduction in their mean pain scores, respectively. This study determined that patients benefit significantly from the removal of calyceal nonobstructing kidney stones for at least 12 weeks with a reduction in pain and an increase in quality of life. Therefore, surgical removal of these stones in this patient population should be offered as a treatment option.

Prommis Trial Prospectively Demonstrates the Efficacy of SKY92 Risk Stratification in Newly Diagnosed Multiple Myeloma Patients

Introduction: Multiple myeloma (MM) is a complex hematologic malignancy characterized by genetic instability, variable survival rates, and diverse treatment responses. SKY92 gene expression profiling (GEP) is a valuable tool in risk stratifying patients into high-risk and standard-risk groups for progression and survival. The PRospective Observational Multiple Myeloma Impact Study (PROMMIS; NCT02911571) trial, a prospective US multicenter study, was designed to validate the prognostic performance of SKY92 through real-world data. Methods: The GEP of 251 newly diagnosed MM patients was assessed using the SKY92 assay (SkylineDx, San Diego), which involved analyzing RNA extracted from CD138-positive plasma cells (≥80% purity) isolated through immunomagnetic separation. The test was performed at the enrolling institute, or by sending the samples into a central lab. The standard method for risk stratification by R-ISS stage was integrated with SKY92 into three distinct groups: Low-Risk (LR), defined by SKY92 standard-risk (SR) combined with R-ISS I; Intermediate Risk (IR), as SKY92 SR with R-ISS II/III, or SKY92 high-risk with R-ISS I; and High-Risk as SKY92 high-risk with R-ISS II/III. Progression-free survival (PFS) and overall survival (OS) were available for 221 patients, measured from the date of diagnosis of the patients. The median follow-up at the time of analysis is 38 months. Survival analyses were performed using Cox proportional hazards model. Results: Upon analysis, 179 patients (71.3%) were classified as SKY92 standard-risk, and 72 patients (28.7%) as SKY92 high-risk. Notably, the percentage of high-risk patients in this study was slightly higher than that observed in previous retrospective analyses (15-25%). Furthermore, the survival analysis revealed significant differences in both PFS (HR: 2.1, 95%CI 1.4-3.1, p<0.001) and OS (HR: 3.7, 95%CI 1.8-7.6, p<0.001) between the two risk categories. The median PFS from the time of the diagnosis for SKY92 standard-risk patients was 50 months, whereas for SKY92 high-risk patients, it was 26 months. The median OS was not reached within the 60-month timeframe for both the standard- and high-risk groups. R-ISS could be determined for 204 patients (81%), of which 29.9% (n=61) were classified as stage I, 59.3% (n=121) as stage II, and 10.8% (n=22) as stage III. We integrated R-ISS staging with SKY92 classification for these patients. The combination of these two classification systems yielded the following stratification ( Figure 1): LR n=53 (27%), IR n=96 (47%), and High-Risk n=55 (26%). Consistent with previous studies, R-ISS and SKY92 hold independent prognostic value: in particular, we found that this combined classification method identified a higher number of patients as high-risk compared to the R-ISS annotation (55 [27%] vs. 22 [11%]). The high-risk group exhibited significantly shorter OS and PFS compared to the LR group (OS: HR:18.7, 95% CI 2.5-140, p=0.004 and PFS: HR:2.6, 95% CI 1.4-4.7, p=0.002). Conclusions: This study represents the first US-based multicenter prospective evaluation of the GEP SKY92 in a real-world clinical setting. The results obtained align with the retrospective validations of SKY92, further confirming its reliability as a prognostic marker for MM patients. In addition, we observed that the SKY92 is able to identify a higher number of high-risk patients, with significantly shorter PFS and OS, compared to the conventional R-ISS staging system. Figure 1: PFS and OS based on SKY92+R-ISS risk classification

A novel explainable online calculator for contrast-induced AKI in diabetics: a multi-centre validation and prospective evaluation study

BackgroundIn patients undergoing percutaneous coronary intervention (PCI), contrast-induced acute kidney injury (CIAKI) is a frequent complication, especially in diabetics, and is connected with severe mortality and morbidity in the short and long term. Therefore, we aimed to develop a CIAKI predictive model for diabetic patients.Methods3514 patients with diabetes from four hospitals were separated into three cohorts: training, internal validation, and external validation. We developed six machine learning (ML) algorithms models: random forest (RF), gradient-boosted decision trees (GBDT), logistic regression (LR), least absolute shrinkage and selection operator with LR, extreme gradient boosting trees (XGBT), and support vector machine (SVM). The area under the receiver operating characteristic curve (AUC) of ML models was compared to the prior score model, and developed a brief CIAKI prediction model for diabetes (BCPMD). We also validated BCPMD model on the prospective cohort of 172 patients from one of the hospitals. To explain the prediction model, the shapley additive explanations (SHAP) approach was used.ResultsIn the six ML models, XGBT performed best in the cohort of internal (AUC: 0.816 (95% CI 0.777–0.853)) and external validation (AUC: 0.816 (95% CI 0.770–0.861)), and we determined the top 15 important predictors in XGBT model as BCPMD model variables. The features of BCPMD included acute coronary syndromes (ACS), urine protein level, diuretics, left ventricular ejection fraction (LVEF) (%), hemoglobin (g/L), congestive heart failure (CHF), stable Angina, uric acid (umol/L), preoperative diastolic blood pressure (DBP) (mmHg), contrast volumes (mL), albumin (g/L), baseline creatinine (umol/L), vessels of coronary artery disease, glucose (mmol/L) and diabetes history (yrs). Then, we validated BCPMD in the cohort of internal validation (AUC: 0.819 (95% CI 0.783–0.855)), the cohort of external validation (AUC: 0.805 (95% CI 0.755–0.850)) and the cohort of prospective validation (AUC: 0.801 (95% CI 0.688–0.887)). SHAP was constructed to provide personalized interpretation for each patient. Our model also has been developed into an online web risk calculator. MissForest was used to handle the missing values of the calculator.ConclusionWe developed a novel risk calculator for CIAKI in diabetes based on the ML model, which can help clinicians achieve real-time prediction and explainable clinical decisions.

A multi-centre prospective evaluation of internet research habits among owners seeing a veterinary oncologist.

The purpose of this study is to evaluate the internet-use among pet owners seeing a veterinary oncologist. Over a two-month period, 137 questionnaires were collected at three specialty hospitals around a large urban city. Approximately 85% of respondents reported using the internet to research their pet's condition and/or treatment. A search engine was the most employed means however veterinary university websites were considered to provide the most accurate information. The odds of owners who researched their own health condition online researching their pet's condition was 4.3 (95% CI: 1.2-23.1, p < .021) times as high as owners who did not research their own health condition. The odds of owners who have been to their oncologist previously to research their pet's condition was 4.7 (95% CI: 26.9.3, p < .001) times as high than owners who have not been to an oncologist previously. Oncologists should be aware internet use among pet owners appears common and further research to assess the accuracy and readability of veterinary medical websites appears indicated.

Multicenter prospective evaluation of an overtube endoluminal interventional platform for colorectal polypectomy

Background and study aims Endoscopic removal of complex colorectal polyps (≥ 2 cm) can be technically challenging. A dual balloon endoluminal overtube platform (DBEP) was developed to facilitate colonoscopic polypectomy. The study purpose was to evaluate clinical outcomes with the DBEP for complex polypectomy. Patients and methods This was an observational, prospective, multicenter Institutional Review Board-approved study. Between January 2018 and December 2020, safety and performance data were collected intra-procedurally and at 1 month post-procedure in patients undergoing intervention with the DBEP at three US centers. The primary endpoint was device safety and technical success of the procedure. Secondary endpoints included navigation time, total procedure time, and user feedback assessment post-procedure. Results A total of 162 patients underwent colonoscopy with the DBEP. Of these, 144 (89 %) underwent 156 interventions successfully with DBEP (44.5 % endoscopic mucosal resection, 53.2 % hybrid endoscopic submucosal dissection (ESD)/ESD, 1.3 % other). In 13 patients (8 %), device challenges contributed to unsuccessful intervention. One mild device-related adverse event (AE) occurred. Procedural AE rate was 8.3 %. Median lesion size was 2.6 cm [range 0.5-12]. The investigators felt that navigating the device was easy/somewhat easy in 78.5 % of successful cases. Median total procedure time was 69 minutes [range, 19-213], median navigation time to lesion was 8 minutes [range, 1-80], And median polypectomy time was 33.5 minutes [range, 2-143]. Conclusions Endoscopic colon polyp resection with the DBEP was safe with a high technical success rate. The DBEP has the potential to provide enhanced scope stability and visualization, traction, and a conduit for scope exchange. Further prospective randomized studies are warranted.

Coordinated prospective follow-up of Lynch syndrome is able to detect the majority of incident cancers

BackgroundLynch syndrome is one of the most common genetic predispositions to many cancers, most of which do not have a consensus recommendation for screening. AimsWe studied in our region the value of a systematized and coordinated follow-up program for patients with Lynch syndrome on all organs at risk. MethodsA multicenter prospective cohort evaluation was performed, from January 2016 to June 2021. ResultsOne hundred and seventy-eight patients were prospectively included (104 women (58%), median age 44 years, range 35–56 years) with a median follow-up of 4 years (range 2.5–5 years), corresponding to a total of 652 patient-years. The overall cancer incidence rate was 13.80 per 1000 patient-years. Seven of nine cancers (78%) were detected during the follow-up program, with all cancers identified at an early stage. The detection rate of adenomas during colonoscopies was 24%. ConclusionThese preliminary data suggest that coordinated prospective follow-up of Lynch syndrome is capable of detecting the majority of incident cancers, particularly for locations not covered by an international follow-up recommendation. However, these results need to be confirmed by larger-scale studies.

Distinct Serum Immune Profiles Define the Spectrum of Acute and Chronic Pancreatitis From the Multicenter Prospective Evaluation of Chronic Pancreatitis for Epidemiologic and Translational Studies (PROCEED) Study

Pancreatitis is a disease continuum, starting with acute pancreatitis (AP) and, in some cases, progressing to recurrent acute pancreatitis (RAP) and chronic pancreatitis (CP). Currently, there are no approved therapies or early diagnostic or prognostic biomarkers for pancreatitis. The current study aimed to examine whether patient serum immune profiling could identify non-invasive biomarkers and provide mechanistic insight into the disease continuum of pancreatitis. Using Olink immunoassay, we assessed the protein levels of 92 immune markers in serum samples from participants enrolled in the PROCEED study of the CPDPC consortium. Samples (n=231) were obtained from subjects without the pancreatic disease (n=56) and those with chronic abdominal pain (CAP) (n=24), AP (n=38), RAP (n=56), and CP (n=57). Thirty-three immune markers differentiated the combined pancreatitis groups from controls. Immune markers related to IL-17 signaling distinguished CP from AP and RAP. Similarly, the serum level of IL-17A and CCL20 differentiated CP from CAP, suggesting the involvement of Th17 cells in CP pathogenesis. The receiver operator characteristic (ROC) curve with two immune markers (IL-17A and ST1A1) could differentiate CP from CAP (optimistic AUC=0.78). Macrophage classical activation pathway elevated along the continuum of pancreatitis, suggesting an accumulation of proinflammatory signals over disease progression. Several immune markers were associated with smoking, alcohol, and diabetes status. Immune profiling of serum samples from a large pancreatitis cohort led to identifying distinct immune markers that could serve as potential biomarkers to differentiate the varying pancreatitis disease states. In addition, the finding of IL-17 signaling in CP could provide insight into the immune mechanisms underlying disease progression.

French multicentre prospective evaluation of radiofrequency ablation in the management of haemorrhoidal disease

PurposeThe aim of this study was to evaluate the efficacy and safety of radiofrequency ablation (RFA) in the management of haemorrhoidal disease with 1 year’s follow-up.MethodThis prospective multicentre study assessed RFA (Rafaelo©) in outpatients with grade II–III haemorrhoids. RFA was performed in the operating room under locoregional or general anaesthesia. Primary endpoint was the evolution of a quality-of-life score adapted to the haemorrhoid pathology (HEMO-FISS-QoL) 3 months after surgery. Secondary endpoints were evolution of symptoms (prolapsus, bleeding, pain, itching, anal discomfort), complications, postoperative pain and medical leave.ResultsA total of 129 patients (69% men, median age 49 years) were operated on in 16 French centres. Median HEMO-FISS-QoL score dropped significantly from 17.4/100 to 0/100 (p < 0.0001) at 3 months. At 3 months, the rate of patients reporting bleeding (21% vs. 84%, p < 0.001), prolapse (34% vs. 91.3%, p < 0.001) and anal discomfort (0/10 vs. 5/10, p < 0.0001) decreased significantly. Median medical leave was 4 days [1–14]. Postoperative pain was 4/10, 1/10, 0/10 and 0/10 at weeks 1, 2, 3 and 4. Seven patients (5.4%) were reoperated on by haemorrhoidectomy for relapse, and three for complications. Reported complications were haemorrhage (3), dysuria (3), abscess (2), anal fissure (1), external haemorrhoidal thrombosis (10), pain requiring morphine (11). Degree of satisfaction was high (+ 5 at 3 months on a − 5/+ 5 scale).ConclusionRFA is associated with an improvement in quality of life and symptoms with a good safety profile. As expected for minimally invasive surgery, postoperative pain is minor with short medical leave.Clinical trial registration and dateClinical trial NCT04229784 (18/01/2020).

Informing ENT training bootcamps - Operating Out-of-hours: A Multicentre Prospective Evaluation.

ENT specialty trainees are invited to national bootcamps to prepare for critical events to which they may have never been exposed. Here, we evaluate the frequency of out-of-hours ENT operations and the level of supervision provided to inform aspiring trainees and the national bootcamps. Information on all ENT operations performed out-of-hours was prospectively recorded by trainees in Kent, Surrey and Sussex over seven months. There was a 100 per cent response rate. The trainee was the most senior surgeon present for 48.4 per cent of out-of-hours operations. Four of the six most frequently performed out-of-hours operations are not included in the ENT indicator procedures, and two are not included in the national ENT bootcamps. Trainees should be aware of the most common procedures they may be expected to perform out-of-hours. Training in these should be provided prior to the commencement of specialty training. The audit design can be replicated across surgical specialties.

ORthopaedic trauma hospital outcomes - Patient operative delays (ORTHOPOD) Study: The management of day-case orthopaedic trauma in the United Kingdom

IntroductionORTHOPOD: Day Case Trauma is a multicentre prospective service evaluation of day-case trauma surgery across four countries. It is an epidemiological assessment of injury burden, patient pathways, theatre capacity, time to surgery and cancellation. It is the first evaluation of day-case trauma processes and system performance at nationwide scale. MethodsData was prospectively recorded through a collaborative approach. Arm one captured weekly caseload burden and operating theatre capacity. Arm two detailed patient and injury demographics, and time to surgery for specific injury groups. Patients scheduled for surgery between 22/08/22 and 16/10/22 and operated on before 31/10/22, were included. For this analysis, hand and spine injuries were excluded. ResultsData was obtained from 86 Data Access Groups (70 in England, 2 in Wales, 10 in Scotland and 4 in Northern Ireland). After exclusions, 709 weeks worth of data representing 23,138 operative cases were analysed. Day-case trauma patients (DCTP) accounted for 29.1% of overall trauma burden and utilised 25.7% of general trauma list capacity. They were predominantly adults aged 18 to 59 (56.7%) with upper limb Injuries (65.7%). Across the four nations, the median number of day-case trauma lists (DCTL) available per week was 0 (IQR 1). 6 of 84 (7.1%) hospitals had at least five DCTLs per week. Rates of cancellation (13.2% day-case; 11.9% inpatient) and escalation to elective operating lists (9.1% day-case; 3.4% inpatient) were higher in DCTPs. For equivalent injuries, DCTPs waited longer for surgery. Distal radius and ankle fractures had median times to surgery within national recommendations: 3 days and 6 days respectively. Outpatient route to surgery was varied. Dominant pathways (>50% patients listed at that episode) in England and Wales were uncommon but the most frequently seen was listing patients in the emergency department, 16 of 80 hospitals (20%). ConclusionThere is significant mismatch in DCTP management and resource availability. There is also considerable variation in DCTP route to surgery. Suitable DCTL patients are often managed as inpatients. Improving day-case trauma services reduces the burden on general trauma lists and this study demonstrates there is considerable scope for service and pathway development and improved patient experience.

Patient-reported Satisfaction and Regret Following Focal Therapy for Prostate Cancer: A Prospective Multicenter Evaluation

BackgroundSeveral reports are available regarding the treatment decision regret of patients receiving conventional treatments for localized prostate cancer (PCa); yet data on patients undergoing focal therapy (FT) are sparse. ObjectiveTo evaluate the treatment decision satisfaction and regret among patients who underwent FT for PCa with high-intensity focused ultrasound (HIFU) or cryoablation (CRYO). Design, setting, and participantsWe identified consecutive patients who underwent HIFU or CRYO FT as the primary treatment for localized PCa at three US institutions. A survey with validated questionnaires, including the five-question Decision Regret Scale (DRS), International Prostate Symptom Score (IPSS), and International Index of Erectile Function (IIEF-5), was mailed to the patients. The regret score was calculated based on the five items of the DRS, and regret was defined as a DRS score of >25. Outcome measurements and statistical analysisMultivariable logistic regression models were applied to assess the predictors of treatment decision regret. Results and limitationsOf 236 patients, 143 (61%) responded to the survey. Baseline characteristics were similar between responders and nonresponders. During a median (interquartile range) follow-up of 43 (26–68) mo, the treatment decision regret rate was 19.6%. On a multivariable analysis, higher prostate-specific antigen (PSA) at nadir after FT (odds ratio [OR] 1.48, 95% confidence interval [CI] 1.1–2, p = 0.009), presence of PCa on follow-up biopsy (OR 3.98, 95% CI 1.5–10.6, p = 0.006), higher post-FT IPSS (OR 1.18, 95% CI 1.01–1.37, p = 0.03), and newly diagnosed impotence (OR 6.67, 95% CI 1.57–27, p = 0.03) were independent predictors of treatment regret. The type of energy treatment (HIFU/CRYO) was not a predictor of regret/satisfaction. Limitations include retrospective abstraction. ConclusionsFT for localized PCa is well accepted by the patients, with a low regret rate. Higher PSA at nadir, presence of cancer on follow-up biopsy, bothersome postoperative urinary symptoms, and impotence after FT were independent predictors of treatment decision regret. Patient summaryIn this report, we looked at the factors affecting satisfaction and regret in patients with prostate cancer undergoing focal therapy. We found that focal therapy is well accepted by the patients, while presence of cancer on follow-up biopsy as well as bothersome urinary symptoms and sexual dysfunction can predict treatment decision regret.

29 Bridge for Meth: Multi-Center Prospective Evaluation of Emergency Department Initiation of Mirtazapine for Problematic Methamphetamine Use

To describe the characteristics and clinical outcomes among ED patients treated with mirtazapine for problematic methamphetamine use at 6 EDs participating in the CA Bridge, Centers of Excellence Program (COE).