Assessment of urologists experience with abiraterone acetate and with a real-world trial: Results obtained from a Canadian Observational Study in Metastatic Cancer of the Prostate (COSMiC).

2017 ◽  
Vol 35 (6_suppl) ◽  
pp. 238-238
Author(s):  
Andrew Feifer ◽  
Vincent Fradet ◽  
Darrel Drachenberg ◽  
Geoffrey Gotto ◽  
Ricardo A. Rendon ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Observational Study ◽  
Real World ◽  
Active Sites ◽  
Metastatic Cancer ◽  
Abiraterone Acetate ◽  
Ease Of Use ◽  
Therapeutic Area ◽  
Patient Reported ◽  
Cancer Of The Prostate

238 Background: Abiraterone Acetate (AA) is a selective inhibitor of the androgen biosynthesis and has significantly improved OS for mCRPC patients. Canadian Observational Study in Metastatic Cancer of the Prostate (COSMiC) is a Non-Interventional Observational Study pPhase IV clinical trial; NCT02364531) specifically designed to (1) collect real-world drug-specific outcomes (clinical and patient reported outcomes) and (2) assess urologists experience with incorporation of AA in their practice. Here we report data collected from COSMiC trial on the success of AA integration into the urology practice and physicians experience in participating in the trial. Methods: (1) A comprehensive questionnaire was developed to assess urologists experience with (a) integration and usage of AA in their practice and (b) COSMiC trial. (2) Questionnaire was sent to the active trial sites (47 sites) and collected data from 30 sites is summarized here. Results: 93.3% of participants in COSMiC trial were urologists (63.3% community vs. 30% academic). The ease of use and success in integration of AA in urology practice was rated easy by 50% of the participants, easy once they overcame few barriers by 46.7% and challenging by 3.3%. Drug-related barriers identified included time involvement (50%), resource issues such as nursing support (23.3%), and lack of appropriate infrastructure (33.3%). 90% of the active sites indicated that treating mCRPC patients with AA will be part of their practice post-trial. As part of this report we also assessed and identified physicians barriers in participating in COSMiC trial. 86.7% of the sites reported that trials such as COSMiC will add value to the therapeutic area and 93.3% of the sites reported interest in participating in trials of this nature in future. Conclusions: This report indicates that integration of AA in urology practices is considered easy and manageable for most urologists, in some cases after overcoming few initial barriers. There is high interest in participating in future real-world trials of this nature among urologists and such studies add value to the therapeutic area. Clinical trial information: NCT02364531.

scholarly journals COSMiC details

2015 ◽  
Vol 9 (1-2) ◽  
Author(s):  
CUAJ Editorial
Keyword(s):  
Prostate Cancer ◽  
Observational Study ◽  
Metastatic Cancer ◽  
Abiraterone Acetate ◽  
Additional Information ◽  
Patient Reported ◽  
Castrate Resistant Prostate Cancer ◽  
Castrate Resistant ◽  
Cancer Of The Prostate ◽  
The Impact

A Canadian Observational Study in Metastatic Cancer of the Prostate: A Study of ZYTIGA Use in the Community Urology Setting. The COSMiC Prospective Prostate Cancer Registry.The purpose of this non-interventional, prospective, observational study is to temporally evaluate the impact of abiraterone acetate (ZYTIGA) therapy on Patient Reported Outcomes (PROs) and on clinical outcomes in the chemotherapy-naive metastatic castrate-resistant prostate cancer (mCRPC) population.Study participants must have a confirmed diagnosis of mCRPC according to medical history and have rising PSA levels or radiographic progression (documented by previous positive bone scan or metastatic lesions identified on CT or MRI) despite ongoing conventional ADT.Study participants will complete Quality of Life and Patient Satisfaction questionnaires longitudinally at defined time points. Safety and efficacy data, as well as levels of health care resource utilization associated with ZYTIGA therapy, will also be prospectively collected and analyzed.Once enrolled, study participants will be followed for a maximum of 72 weeks from the time of initiation of ZYTIGA treatment, or up to the time of early study withdrawal/termination.For additional information please contact Richard K. Plante at [email protected]

scholarly journals Real-world evidence in patient-reported outcomes (PROs) of metastatic castrate-resistant prostate cancer (mCRPC) patients treated with abiraterone acetate + prednisone (AA+P) across Canada: Final results of COSMiC

2020 ◽  
Vol 14 (12) ◽  
Author(s):  
Geoffrey Gotto ◽  
Darrel E. Drachenberg ◽  
Joseph Chin ◽  
Richard Casey ◽  
Vincent Fradet ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Real World ◽  
Patient Reported Outcomes ◽  
Short Form ◽  
Metastatic Cancer ◽  
Abiraterone Acetate ◽  
Cognitive Status ◽  
Patient Reported ◽  
Castrate Resistant Prostate Cancer ◽  
Castrate Resistant

Introduction: Abiraterone acetate plus prednisone (AA+P) has shown to significantly improve survival. COSMiC, a Canadian Observational Study in Metastatic Cancer of the Prostate, set out to prospectively amass real-world data on metastatic castrate-resistant prostate cancer (mCRPC) patients managed with AA+P in Canada. Here, we report their patient-reported outcomes (PROs). Methods: After a median followup of 67.1 weeks, 254 patients were enrolled across 39 sites. Functional Assessment of Cancer Therapy-Prostate (FACT-P), Montreal Cognitive Assessment (MoCA), Brief Pain Inventory-Short form (BPI-SF), Brief Fatigue Inventory (BFI), and Current Health Satisfaction in Prostate Cancer (CHS-PCa) were evaluated at baseline, as well as at weeks 12, 24, 48, and 72 after AA+P initiation. Descriptive analysis was used with continuous variables. Changes from baseline were summarized using mean (standard deviation [SD]). Results: At a median age of 76.6 (8.94), baseline FACT-P total score was 111.3 (19.56) with no significant change in their functional status observed from baseline over time. The median baseline MoCA score was 25.2 (4.52), yet subsequent assessments showed an absence of cognitive decline while under treatment. Similarly, no meaningful changes were detected in BPI, BFI, and CHS-PCa during the 72-week study period, thus suggesting that patients’ PROs were well-maintained throughout AA+P treatment. Prostate-specific antigen (PSA) response with >50% decline was 66.4%. Safety profile was consistent with the known side effect of AA+P. Conclusions: COSMiC represents the largest Canadian mCRPC cohort treated with AA+P with real-world, prospective evaluation of PROs. This data demonstrated the maintenance in quality of life and cognitive status over the course of the study and underscores the importance of PRO use in this complex patient population.

scholarly journals The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Samantha Cruz Rivera ◽  
Derek G. Kyte ◽  
Olalekan Lee Aiyegbusi ◽  
Anita L. Slade ◽  
Christel McMullan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Case Studies ◽  
Real World ◽  
Clinical Trial Data ◽  
Research Impact ◽  
Trial Data ◽  
Patient Reported ◽  
The Impact

Abstract Background Patient-reported outcomes (PROs) are commonly collected in clinical trials and should provide impactful evidence on the effect of interventions on patient symptoms and quality of life. However, it is unclear how PRO impact is currently realised in practice. In addition, the different types of impact associated with PRO trial results, their barriers and facilitators, and appropriate impact metrics are not well defined. Therefore, our objectives were: i) to determine the range of potential impacts from PRO clinical trial data, ii) identify potential PRO impact metrics and iii) identify barriers/facilitators to maximising PRO impact; and iv) to examine real-world evidence of PRO trial data impact based on Research Excellence Framework (REF) impact case studies. Methods Two independent investigators searched MEDLINE, EMBASE, CINAHL+, HMIC databases from inception until December 2018. Articles were eligible if they discussed research impact in the context of PRO clinical trial data. In addition, the REF 2014 database was systematically searched. REF impact case studies were included if they incorporated PRO data in a clinical trial. Results Thirty-nine publications of eleven thousand four hundred eighty screened met the inclusion criteria. Nine types of PRO trial impact were identified; the most frequent of which centred around PRO data informing clinical decision-making. The included publications identified several barriers and facilitators around PRO trial design, conduct, analysis and report that can hinder or promote the impact of PRO trial data. Sixty-nine out of two hundred nine screened REF 2014 case studies were included. 12 (17%) REF case studies led to demonstrable impact including changes to international guidelines; national guidelines; influencing cost-effectiveness analysis; and influencing drug approvals. Conclusions PRO trial data may potentially lead to a range of benefits for patients and society, which can be measured through appropriate impact metrics. However, in practice there is relatively limited evidence demonstrating directly attributable and indirect real world PRO-related research impact. In part, this is due to the wider challenges of measuring the impact of research and PRO-specific issues around design, conduct, analysis and reporting. Adherence to guidelines and multi-stakeholder collaboration is essential to maximise the use of PRO trial data, facilitate impact and minimise research waste. Trial registration Systematic Review registration PROSPERO CRD42017067799.

Real-world evidence in patient-related outcomes (PROs) of metastatic castrate-resistant prostate cancer (mCRPC) patients treated with abiraterone acetate plus prednisone (AA+P).

2018 ◽  
Vol 36 (6_suppl) ◽  
pp. 196-196 ◽  
Author(s):  
Geoffrey Gotto ◽  
Vincent Fradet ◽  
Darrel Drachenberg ◽  
Robert Sabbagh ◽  
Ricardo A. Rendon ◽  
...  
Keyword(s):  
Real World ◽  
Metastatic Cancer ◽  
Abiraterone Acetate ◽  
Cognitive Status ◽  
Continuous Variables ◽  
Absolute Change ◽  
The Mean ◽  
Clinically Significant ◽  
Moca Score ◽  
Over Time

196 Background: Oral androgen biosynthesis inhibitor, abiraterone acetate plus prednisone (AA+P), has shown to improve survival and patient-related outcomes (PROs) in clinical trials. The COSMiC study (Canadian Observational Study in Metastatic Cancer of the Prostate; ClinicalTrials.gov: NCT02364531) set out to prospectively amass real-world data on mCRPC patients (pts) managed with AA+P in communities within Canada. Here, we report the interim analysis of their PROs. Methods: At planned data cutoff in Sept 2017 after a median follow-up of 33.8 months, 264 pts were enrolled in 39 sites across Canada. Their FACT-P (Functional Assessment of Cancer Therapy – Prostate) and MoCA (Montreal Cognitive Assessment) were evaluated at baseline as well as at weeks 12, 24, 48 and 72 after AA+P initiation. A 10-point decrease denotes clinically significant degradation in FACT-P and a total MoCA score of > = 26 is considered normal. Descriptive analysis was utilized with continuous variables. Changes from baseline were summarized using mean (SD). Results: At a median age of 77 among 264 pts, 230, 185, 110 and 63 pts were available for analysis at their week 12, 24, 48, and 72 assessments respectively. The mean baseline FACT-P total score was 111.2 (19.44) with a < 3-point absolute change from baseline at subsequent assessments, denoting no clinically significant change in functional status over time. The mean baseline MoCA score was 25.2 (4.50), yet all subsequent assessments scored above 26 and a mean absolute change from baseline of < 1, showing an absence of cognitive decline over time. PSA value was available for 221 pts, 64.3% (142/221) and 34.4% (76/221) achieved a PSA decline of > 50% and 90% respectively. All-grade treatment-related adverse events were reported in 63 pts, with 11% who have had AA+P discontinuation or interruption. Conclusions: COSMiC represents the largest Canadian mCRPC cohort treated with AA+P with real world prospective evaluation of PROs. This data demonstrated the maintenance in quality of life and cognitive status over the course of the study, and underscores the importance of PRO utilization in this complex patient population. Clinical trial information: NCT02364531.

Real-world effectiveness of nab-paclitaxel plus carboplatin as first-line therapy for patients with advanced NSCLC: Results of the second interim analysis of the NEPTUN study.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e21611-e21611
Author(s):  
Tobias Nicolaas Dechow ◽  
Jorge Riera-Knorrenschild ◽  
Björn Hackanson ◽  
Ludwig Fischer von Weikersthal ◽  
Holger Schulz ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Real World ◽  
Interim Analysis ◽  
Active Sites ◽  
Advanced Nsclc ◽  
Cox Regression ◽  
Small Cell Lung Carcinoma ◽  
Phase Iii ◽  
First Line ◽  
Cell Lung Carcinoma

e21611 Background: Collecting real-world evidence is required not only to evaluate effectiveness and safety in routine clinical practice, but to improve clinical cancer outcomes. Methods: NEPTUN is a prospective, multicenter, non-interventional study designed to evaluate effectiveness, safety and quality of life (QoL) of first-line nab-Paclitaxel plus carboplatin in patients (pts) with advanced or metastatic non-small cell lung carcinoma (NSCLC) in the real-world setting in Germany. The primary endpoint was 6-months progression free survival rate (PFSR). Descriptive statistics were used to analyze data. Results: Between August 2016 and June 2019, 408 pts were enrolled at 75 active sites, 373 pts started treatment according to label. The cut-off date for this interim analysis (07 Dec 2019) was after all pts were observed for at least 6 months. The 6-months PFSR was 40.8% (95% CI, 35.3-46.2), median PFS 5.2 months (95% CI, 4.5-5.7). Overall response rate was 41.5% (95% CI, 36.3-46.8) with a complete response documented in 6 pts (1.7%) and a partial response in 142 pts (39.8%). Disease control rate was 61.6% (95% CI, 56.4-66.7). Employing a multivariable cox regression model for PFS adjusted for ECOG, histology, age group, renal impairment, and smoking status, elderly patients and patients with squamous histology were identified as being of favorable risk (HR squamous vs. non-squamous histology 0.76 (95% CI, 0.58-1.01); HR for ≥70 vs. < 70 years of age 0.80 (95% CI, 0.59-1.08)). Median overall survival (OS) was 10.5 months (95% CI, 9.2-11.6) with 9.6 months (95% CI, 7.7-11.2) for non-squamous and 11.8 months (95% CI, 9.2-13.8) for squamous histology. 12-months OS rate was 43.1% (95% CI, 37.3-48.7). The most common treatment-emergent AEs (TEAEs) were anemia (26.5%), leukopenia (25.7%) and thrombocytopenia (16.6%). Polyneuropathy was documented for 11.3% of pts. 54.2% of pts developed TEAE grade 3/4 including leukopenia (10.2%), anemia (8.6%) and pneumonia (5.1%). 9.9% pts discontinued nab-paclitaxel due to nab-paclitaxel-related TEAEs. EQ-5D-5L visual analogue scale and FACT-L total score remained stable during therapy. Conclusions: nab-Paclitaxel plus carboplatin given first-line according to German SmPC in advanced NSCLC patients in a real-world clinical setting is an effective and safe therapy commonly applied. These results were similar to those reported in the phase iii clinical trial setting. QoL scores remained stable during first-line treatment. No new safety signals emerged. Clinical trial information: NCT02799862.

scholarly journals A Novel, Integrative Approach for Evaluating Progression in Multiple Sclerosis: Development of a Scoring Algorithm

10.2196/17592 ◽  
2020 ◽  
Vol 8 (4) ◽  
pp. e17592 ◽  
Author(s):  
Chloe Tolley ◽  
Daniela Piani-Meier ◽  
Sarah Bentley ◽  
Bryan Bennett ◽  
Eddie Jones ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Qualitative Research ◽  
Logistic Regression ◽  
Observational Study ◽  
Real World ◽  
Comprehensive Approach ◽  
Multiple Logistic Regression ◽  
Patient Reported ◽  
Scoring Algorithm ◽  
Reported Data

Background There is an unmet need for a tool that helps to evaluate patients who are at risk of progressing from relapsing-remitting multiple sclerosis to secondary progressive multiple sclerosis (SPMS). A new tool supporting the evaluation of early signs suggestive of progression in multiple sclerosis (MS) has been developed. In the initial stage, concepts relevant to progression were identified using a mixed method approach involving regression on data from a real-world observational study and qualitative research with patients and physicians. The tool was drafted in a questionnaire format to assess these variables. Objective This study aimed to develop the scoring algorithm for the tool, using both quantitative and qualitative research methods. Methods The draft scoring algorithm was developed using two approaches: quantitative analysis of real-world data and qualitative analysis based on physician interviews and ranking and weighting exercises. Variables that were included in the draft tool and regarded as most clinically relevant were selected for inclusion in a multiple logistic regression. The analyses were run using physician-reported data and patient-reported data. Subsequently, a ranking and weighting exercise was conducted with 8 experienced neurologists as part of semistructured interviews. Physicians were presented with the variables included in the draft tool and were asked to rank them in order of strength of contribution to progression and assign a weight by providing a percentage of the overall contribution. Physicians were also asked to explain their ranking and weighting choices. Concordance between physicians was explored. Results Multiple logistic regression identified age, MS disease activity, and Expanded Disability Status Scale score as the most significant physician-reported predictors of progression to SPMS. Patient age, mobility, and self-care were identified as the strongest patient-reported predictors of progression to SPMS. In physician interviews, the variables ranked and weighted as most important were stability or worsening of symptoms, intermittent or persistent symptoms, and presence of ambulatory and cognitive symptoms. Across all physicians, the level of concordance was 0.278 (P<.001), indicating a low to moderate, but statistically significant, level of agreement. Variables were categorized as high (n=8), moderate (n=8), or low (n=10) importance based on the findings from the different approaches described above. Accordingly, the respective questions in the tool were assigned a weight of “three,” “two,” or “one” to inform the draft scoring algorithm. Conclusions This study further confirms the need for a tool to provide a consistent, comprehensive approach across physicians to support the early evaluation of signs indicative of progression to SPMS. The novel and comprehensive approach to develop the draft scoring algorithm triangulates data obtained from ranking and weighting exercises, qualitative interviews, and a real-world observational study. Variables that go beyond the clinically most obvious impairment in lower limbs have been identified as relevant subtle/sensitive signs suggestive of progressive disease.

Axitinib treatment among patients with mRCC in a U.S. community oncology setting: A retrospective study of 135 patients.

2016 ◽  
Vol 34 (2_suppl) ◽  
pp. 569-569 ◽  
Author(s):  
Thomas Hutson ◽  
Xiaolong Jiao ◽  
Thomas Wilson ◽  
Laura A. Cisar ◽  
Elizabeth A. MacLean
Keyword(s):  
Clinical Trial ◽  
Retrospective Study ◽  
Real World ◽  
Ease Of Use ◽  
Eligibility Criteria ◽  
Duration Of Therapy ◽  
Common Prior ◽  
Community Oncology ◽  
Line Of Therapy ◽  
Line Setting

569 Background: We have previously reported differences in a variety of outcome measures between clinical trial and real world use of several therapies for advanced renal cell carcinoma (RCC) (Vogelzang NJ, et al. Clin Genitourin Cancer, 2015, Hutson TE et al. Lancet Oncol, 2013, Motzer RJ, et al. NEJM, 2013). In an attempt to better understand the real-world use of axitinib in patients (pts) with metastatic RCC (mRCC) after one prior systemic therapy, a retrospective study was conducted using the US Oncology’s (USON) iKnowMed electronic health records database and medical record review data. Methods: Eligibility criteria were: pts with mRCC ≥ 18 years of age at first diagnosis, treated with VEGFR-TKIs or immunotherapy including IL-2 and IFN as first line of therapy (LOT), received second or third line axitinib between 1/1/2012 and 10/31/2014, with ≥ 2 visits within the USON. LOT was defined based on treatment sequence. Dosing analysis included duration of therapy, dose change, and reasons for discontinuation. Results: 135 pts met eligibility criteria. The most common prior therapies were sunitinib (48.5%) and pazopanib (48.5%) for pts with axitinib as 2nd LOT (n=68), and everolimus (55.2%), temsirolimus (19.4%), and pazopanib (14.9%) for pts with axitinib as 3rdLOT (n=67). 80.7% (109) of pts started axitinib at 5mg BID, and 68.9% remained at this dose. 17.8% had a dose increase mainly due to physician’s choice and 13.3% a dose decrease mainly due to toxicity. The median duration of therapy was 4.57 months (mean 6.32, SD 5.91, range 0.03-35.49). Axitinib was discontinued in 91 (67.4%) pts, and the most common reasons for discontinuation were disease progression (39.3%) and toxicity (17.0%). Conclusions: In the community oncology setting, axitinib was commonly used in the 2nd and 3rd line setting for pts with mRCC. The usage pattern appears to be consistent with published NCCN guideline recommendations. Surprisingly and in contrast to our experience with other agents for RCC, dose changes were less common and duration of therapy was consistent with the pivotal clinical trial results. These findings suggest ease of use among community oncologists and patient tolerance are key features of axitinib.

scholarly journals Laser Ablation of Abnormal Neurological Tissue Using Robotic NeuroBlate System (LAANTERN): 12-Month Outcomes and Quality of Life After Brain Tumor Ablation

Neurosurgery ◽  
2020 ◽  
Vol 87 (3) ◽  
pp. E338-E346 ◽  
Author(s):  
Albert H Kim ◽  
Steven Tatter ◽  
Ganesh Rao ◽  
Sujit Prabhu ◽  
Clark Chen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Brain Tumor ◽  
Laser Ablation ◽  
Real World ◽  
Metastatic Cancer ◽  
Karnofsky Performance Score ◽  
Disease Etiology ◽  
Primary Tumors ◽  
Patient Reported

Abstract BACKGROUND Laser Ablation of Abnormal Neurological Tissue using Robotic NeuroBlate System (LAANTERN) is an ongoing multicenter prospective NeuroBlate (Monteris Medical) LITT (laser interstitial thermal therapy) registry collecting real-world outcomes and quality-of-life (QoL) data. OBJECTIVE To compare 12-mo outcomes from all subjects undergoing LITT for intracranial tumors/neoplasms. METHODS Demographics, intraprocedural data, adverse events, QoL, hospitalizations, health economics, and survival data are collected; standard data management and monitoring occur. RESULTS A total of 14 centers enrolled 223 subjects; the median follow-up was 223 d. There were 119 (53.4%) females and 104 (46.6%) males. The median age was 54.3 yr (range 3-86) and 72.6% had at least 1 baseline comorbidity. The median baseline Karnofsky Performance Score (KPS) was 90. Of the ablated tumors, 131 were primary and 92 were metastatic. Most patients with primary tumors had high-grade gliomas (80.9%). Patients with metastatic cancer had recurrence (50.6%) or radiation necrosis (40%). The median postprocedure hospital stay was 33.4 h (12.7-733.4). The 1-yr estimated survival rate was 73%, and this was not impacted by disease etiology. Patient-reported QoL as assessed by the Functional Assessment of Cancer Therapy-Brain was stabilized postprocedure. KPS declined by an average of 5.7 to 10.5 points postprocedure; however, 50.5% had stabilized/improved KPS at 6 mo. There were no significant differences in KPS or QoL between patients with metastatic vs primary tumors. CONCLUSION Results from the ongoing LAANTERN registry demonstrate that LITT stabilizes and improves QoL from baseline levels in a malignant brain tumor patient population with high rates of comorbidities. Overall survival was better than anticipated for a real-world registry and comparative to published literature.

scholarly journals Patient experience with NER1006 as a bowel preparation for colonoscopy: a prospective, multicenter US survey

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Brooks D. Cash ◽  
Mary Beth C. Moncrief ◽  
Michael S. Epstein ◽  
David M. Poppers
Keyword(s):  
Patient Satisfaction ◽  
Patient Experience ◽  
Bowel Preparation ◽  
Real World ◽  
Online Survey ◽  
Ease Of Use ◽  
Multicenter Survey ◽  
Patient Reported ◽  
History Of ◽  
Bowel Preparations

Abstract Background NER1006 (Plenvu®, Salix Pharmaceuticals, Bridgewater, NJ) is a 1 L polyethylene glycol bowel preparation indicated for colonoscopy in adults. A US online survey assessed real-world ease of use and treatment satisfaction in individuals who received NER1006. Methods Adults were recruited from 444 US community gastrointestinal practices and provided a kit number for enrollment into an online survey to be completed within 2 weeks. Survey questions evaluated colonoscopy history and prior bowel preparation(s) prescribed, patient experience during NER1006 administration, and patient satisfaction with the bowel preparation process. A 9-point predefined grading scale was used to evaluate ease of NER1006 preparation and consumption (range, 1 “very difficult” to 9 “very easy”); the perceived importance of volume requirement and clear liquid options (range, 1 “not important at all” to 9 “very important”); and patient satisfaction (range, 1 “not satisfied at all” to 9 “very satisfied”). Results 1630 patients were enrolled, 1606 underwent colonoscopy, and 1598 completed the survey between September 15, 2018 and February 28, 2019. Among 1606 patients who had a colonoscopy, 62.5% were female, and the mean patient age was 54.4 years (range 18–89 years). Most patients (74.7%) did not report a family history of colon cancer, 62.6% had undergone prior colonoscopy, and 64.8% were undergoing colonoscopy for routine colorectal cancer screening. A majority (76.1%) of patients who completed the survey reported that NER1006 was very easy to prepare and take, and 89.9% were very or moderately satisfied with NER1006 overall. Most (97.6%) patients reported consuming all or most of the bowel preparation. Among 1005 patients with previous bowel preparation use, 84.7% indicated that their experience with NER1006 was much better or better (65.3%) or about the same (19.4%) compared with previously used bowel preparations, while only 15.3% rated NER1006 as worse or much worse. Conclusions In this first real-world, US multicenter survey, patient-reported experience with NER1006 as a bowel preparation for colonoscopy was favorable and adherence was high. The majority of patients were very or moderately satisfied with the overall experience and found it much better/better than previously used bowel preparations. Trial registration: Not applicable

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