scholarly journals Multi-Institutional Study of Dorsal Onlay Urethroplasty of the Membranous Urethra after Endoscopic Prostate Procedures: Operative Results, Continence, Erectile Function and Patient Reported Outcomes

2021 ◽  
Vol 10 (17) ◽  
pp. 3969
Author(s):  
Javier C. Angulo ◽  
Juan F. Dorado ◽  
Connor G. Policastro ◽  
Francisco E. Martins ◽  
Keith Rourke ◽  
...  
Keyword(s):  
Patient Reported Outcomes ◽  
De Novo ◽  
Endoscopic Procedures ◽  
Urethral Stenosis ◽  
Buccal Mucosal Graft ◽  
Institutional Review ◽  
Operative Care ◽  
Patient Reported ◽  
Dorsal Onlay ◽  
Posterior Urethral Stenosis

(1) Background: To critically evaluate dorsal onlay buccal mucosal graft urethroplasty (DOBMGU) for posterior urethral stenosis repair following transurethral resection and other endoscopic prostate procedures. (2) Methods: A retrospective multi-institutional review of patients with membranous or bulbomembranous urethral stenosis for whom treatment with DOBMGU was conducted after receipt of prostate endoscopic procedures. Baseline data, peri-operative care, post-operative care and patient-reported outcomes were analyzed. The primary outcomes were procedural failure and development of de novo stress urinary incontinence (SUI). The secondary outcomes were changes in voiding, sexual function and patient satisfaction. (3) Results: A total of 107 men with a mean age of 69 ± 9.5 years and stenosis length of 3.5 ± 1.8 cm were included. Prior endoscopic procedures among participants were 47 patients (44%) with monopolar TURP, 33 (30.8%) with bipolar TURP, 16 (15%) with Greenlight laser, 9 (8.4%) with Holmium laser enucleation and 2 (1.9%) with bladder neck incision. At a mean follow-up time of 59.3 ± 45.1 months, stenosis recurred in 10 patients (9.35%). Multivariate analysis confirmed that postoperative complications (OR 12.5; p = 0.009), history of radiation (OR 8.3; p = 0.016) and ≥2 dilatations before urethroplasty (OR 8.3; p = 0.032) were independent predictors of recurrence. Only one patient (0.9%) developed de novo SUI. Patients experienced significant improvement in PVR (128 to 60 cc; p = 0.001), Uroflow (6.2 to 16.8 cc/s; p = 0.001), SHIM (11.5 to 11.7; p = 0.028), IPSS (20 to 7.7; p < 0.001) and QoL (4.4 to 1.7; p < 0.001), and 87 cases (81.3%) reported a GRA of + 2 or better. (4) Conclusions: DOBMGU is an effective and safe option for patients with posterior urethral stenosis following TURP and other prostate endoscopic procedures. This non-transecting approach minimizes external urinary sphincter manipulation, thus limiting postoperative risk of SUI or erectile dysfunction.

scholarly journals Patient‐reported outcomes after buccal mucosal graft urethroplasty for bulbar urethral strictures: results of a prospective single‐centre cohort study

2020 ◽  
Vol 126 (6) ◽  
pp. 684-693 ◽  
Author(s):  
Pieter D’hulst ◽  
Tim Muilwijk ◽  
Kathy Vander Eeckt ◽  
Frank Van der Aa ◽  
Steven Joniau
Keyword(s):  
Cohort Study ◽  
Patient Reported Outcomes ◽  
Single Centre ◽  
Urethral Strictures ◽  
Buccal Mucosal Graft ◽  
Patient Reported

Evaluation of immune-related adverse events (irAE): Utilizing the patient-reported outcomes of the common terminology criteria for adverse events (PRO-CTCAE) in a phase II study of ipilimumab (ipi) in men with castration-sensitive prostate cancer (CSPC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24174-e24174
Author(s):  
Daniel Vargas Pivato de Almeida ◽  
Justine Anderson ◽  
Daniel Costin Danila ◽  
Michael J. Morris ◽  
Susan F. Slovin ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Adverse Events ◽  
Patient Reported Outcomes ◽  
Potential Role ◽  
De Novo ◽  
Limited Data ◽  
Patient Reported ◽  
The Common ◽  
Clinical Trial Information

e24174 Background: Incorporation of the PRO-CTCAE during chemotherapy is associated with fewer ER visits and improved survival. Limited data exist using this tool to capture irAE in immunotherapy trials. We collected select PRO-CTCAEs in a clinical trial evaluating an immune checkpoint inhibitor (ICI) in patients (pts) with CSPC. Methods: Cohort A (Coh A) enrolled de novo metastatic CSPC; Cohort B (Coh B) enrolled recurrent CSPC after radical prostatectomy (RP). Treatment consisted of 4 doses of ipi and 8 months of androgen deprivation therapy (ADT) in Coh A & B, and RP in Coh A. PRO-CTCAEs were collected at each ipi or ADT administration, and during follow-up. PRO-CTCAE items included abdominal pain, diarrhea, fatigue, anorexia, nausea, vomiting, rash and pruritus, with the correspondent attributes of frequency (freq), severity (sev), interference (int), and presence. Results: 16 pts were treated (Coh A: 7; Coh B: 9) with 181 matched pairs of PRO-CTCAE and CTCAE. The study was terminated early for an unfavorable risk:benefit ratio. PRO-CTCAE completion at required visits was 85.4% in Coh A and 98.1% in Coh B. Cohen’s kappa coefficients was lowest for pruritus (k = 0.10, slight agreement) and highest for rash (k = 0.64, moderate agreement). CTCAE captured diarrhea in 10 pts, 4 of whom received steroids. 75% (3/4) of pts receiving steroids graded diarrhea as ‘frequently’ or ‘almost constantly’ on the PRO-CTCAE while 66.7% (4/6) of those who did not receive steroids reported the same frequency. Conclusions: IrAE were more commonly reported and of higher grade by patients using the PRO-CTCAE as compared to clinician reporting, consistent with existing literature in non-ICI studies. Diarrhea as reported by the PRO-CTCAE did not associate with steroid use in this small trial. Further studies are needed to evaluate irAE using PRO-CTCAEs and the potential role in management of these toxicities. Clinical trial information: NCT02020070 . [Table: see text]

scholarly journals Knee replacement outcome predicted by physiotherapists: a prospective cohort study

PeerJ ◽  
2021 ◽  
Vol 9 ◽  
pp. e10838
Author(s):  
Marius Henriksen ◽  
Hiwa Mukriyani ◽  
Carsten Juhl
Keyword(s):  
Patient Reported Outcomes ◽  
Treatment Success ◽  
Oxford Knee Score ◽  
Predictive Performance ◽  
Osteoarthritis Of The Knee ◽  
Operative Care ◽  
Patient Reported ◽  
Euroqol 5D ◽  
Patient Acceptable Symptom State ◽  
Source Of Information

Background Knee arthroplasty (KA) is commonly used for osteoarthritis of the knee joint and it is a highly successful procedure. Still, KA leaves 20% of patients dissatisfied with their outcome. The purpose of this study was to determine if a prognosis made by physiotherapists at the orthopaedic wards during the first post-operative days could predict the 6- and 12-months outcome of KA. Methods Physiotherapists at two orthopaedic wards in Denmark were asked to predict the 6- and 12-months outcome of the KA patients they have treated post-operatively on a 0–10 scale (10 representing the best prognosis). At 6 and 12 months post-operatively the patients answered the Oxford Knee Score (OKS), EuroQol 5D-3L and Patient Acceptable Symptom State (PASS). Multivariable logistic regression analyses were performed to assess the prediction of PASS and treatment success. We assessed predictive performance by examining measures of calibration and discrimination. Results A total of 361 patients were included. The models for PASS and Treatment Success showed poor to acceptable discriminative values (OR between 1.47 and 1.92 and areas under the curves of 0.62–0.73), however the calibration plots indicated significant uncertainties in the prediction. Conclusion Physiotherapists prognoses of recovery after KA are associated with 6- and 12-months patient reported outcomes and satisfaction but have weak predictive value. This study suggests that physiotherapists’ prognoses may be useful as an additional source of information when identifying patients in need of additional post-operative care.

scholarly journals Study protocol for the Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): a longitudinal study of the medium and long-term sequelae of SARS-CoV-2 infection

2021 ◽  
Author(s):  
Kelli N. O’Laughlin ◽  
Matthew Thompson ◽  
Bala Hota ◽  
Michael Gottlieb ◽  
Ian D. Plumb ◽  
...  
Keyword(s):  
Longitudinal Study ◽  
Relative Risk ◽  
Patient Reported Outcomes ◽  
Digital Health ◽  
Nucleic Acid Amplification ◽  
Health Records ◽  
Institutional Review ◽  
Patient Reported

ABSTRACTBACKGROUNDReports on medium and long-term sequelae of SARS-CoV-2 infections largely lack quantification of incidence and relative risk. We describe the rationale and methods of the Innovative Support for Patients with SARS-CoV-2 Registry (INSPIRE) that combines patient-reported outcomes with data from digital health records to understand predictors and impacts of SARS-CoV-2 infection.METHODSINSPIRE is a prospective, multicenter, longitudinal study of individuals with symptoms of SARS-CoV-2 infection in eight regions across the US. Included are adults fluent in English or Spanish, with self-reported symptoms suggestive of acute SARS-CoV-2 infection, enrolled within 42 days of having a US Food and Drug Administration approved SARS-CoV-2 viral test (i.e., nucleic acid amplification test or antigen test). Recruitment occurs in-person, by phone or email, and through online advertisement. A secure online platform is used to facilitate the collation of consent-related materials, digital health records, and responses to self-administered surveys. Participants will be followed for up to 18 months, with patient-reported outcomes collected every three months via survey and linked to concurrent digital health data; follow-up includes no in-person involvement. Our maximum expected enrollment is 4,800 participants, including 3,600 SARS-CoV-2 positive and 1,200 SARS-CoV-2 negative participants (as a concurrent comparison group). These data will allow assessment of longitudinal outcomes from SARS-CoV-2 infection and comparison of the relative risk of outcomes in individuals with and without infection. Patient-reported outcomes include self-reported health function and status, as well as clinical outcomes including health system encounters and new diagnoses.RESULTSParticipating sites obtained institutional review board approval. Enrollment and follow-up are ongoing.CONCLUSIONSThis study will characterize medium and long-term sequelae of SARS-CoV-2 infection among a diverse population, predictors of sequelae, and their relative risk compared to persons with similar symptomatology but without SARS-CoV-2 infection. These data may inform clinical interventions for individuals with sequelae of SARS-CoV-2 infection.

scholarly journals Fox Insight Collects Online, Longitudinal Patient-Reported Outcomes and Genetic Data on Parkinson’s disease

2019 ◽  
Author(s):  
Luba Smolensky ◽  
Ninad Amondikar ◽  
Karen Crawford ◽  
Scott Neu ◽  
Catherine M. Kopil ◽  
...  
Keyword(s):  
Parkinson’S Disease ◽  
Parkinson's Disease ◽  
Patient Reported Outcomes ◽  
Genetic Data ◽  
Health Study ◽  
Nucleotide Polymorphisms ◽  
Data Set ◽  
Institutional Review ◽  
Patient Reported ◽  
Rich Data

AbstractFox Insight is an online, longitudinal health study of people with and without Parkinson’s disease with targeted enrollment set to at least 125,000 individuals. Fox Insight data is a rich data set facilitating discovery, validation, and reproducibility in Parkinson’s disease research. The dataset is generated through routine longitudinal assessments (health and medical questionnaires evaluated at regular cycles), one-time questionnaires about environmental exposure and healthcare preferences, and genetic data collection.Qualified Researchers can explore, analyze, and download patient-reported outcomes (PROs) data and Parkinson’s disease-related genetic variants at https://foxden.michaeljfox.org. The full Fox Insight genetic data set, including approximately 600,000 single nucleotide polymorphisms (SNPs), can be requested separately with institutional review and are described outside of this data descriptor.Fox Insight is sponsored by The Michael J. Fox Foundation for Parkinson’s Research.

scholarly journals SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (9) ◽  
pp. e052494
Author(s):  
Nicole E Billingy ◽  
Vashti N M F Tromp ◽  
Evalien Veldhuijzen ◽  
Jose Belderbos ◽  
Neil K Aaronson ◽  
...  
Keyword(s):  
Lung Cancer ◽  
The Netherlands ◽  
Web Application ◽  
Patient Reported Outcomes ◽  
Intervention Group ◽  
Stepped Wedge ◽  
Symptom Monitoring ◽  
Trial Register ◽  
Institutional Review ◽  
Patient Reported

IntroductionLung cancer and its treatment cause a wide range of symptoms impacting the patients’ health-related quality of life (HRQoL). The use of patient-reported outcomes (PRO) to monitor symptoms during and after cancer treatment has been shown not only to improve symptom management but also to improve HRQoL and overall survival (OS). Collectively, these results favour implementation of PRO-symptom monitoring in daily clinical care. However, these promising outcomes have been obtained under trial conditions in which patients were selected based on stringent inclusion criteria, and in countries with a dissimilar healthcare system than in the Netherlands.The primary aim of the SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung) study is to evaluate the effect of PRO-symptom monitoring during and after lung cancer treatment on HRQoL in daily clinical practice. Secondary objectives include assessing the effect of PRO-symptom monitoring on progression-free survival, OS, the incidence and grade of PRO symptoms, medication adherence, implementation fidelity and cost-effectiveness.Methods and analysisThe SYMPRO-Lung study is a prospective, multicentre trial with a stepped wedge cluster randomised design. Study participants (n=292 intervention, n=292 controls) include patients with lung cancer (stages I–IV) starting treatment with surgery, systemic treatment, targeted treatment and/or radiotherapy.Every participating centre will consecutively switch from the control period to the intervention period, in which patients report their symptoms weekly via an online tool. In the intervention group, we evaluate two alert approaches: the active and reactive approach. If the symptoms exceed a predefined threshold, an alert is sent to the healthcare provider (active approach) or to the patient (reactive approach). Both the control and intervention group complete HRQoL questionnaires at 4 time points: at baseline, 15 weeks, 6 months and 1-year post treatment). Differences in HRQoL between the groups will be compared using linear mixed modelling analyses, accounting for within-centre clustering, potential time effects and confounding.Ethics and disseminationThe study protocol was approved by the Institutional Review Board and the Medical Ethics Committee of the Amsterdam UMC (under number NL 68440.029.18) and the institutional review boards of the participating study sites. The dissemination of the results will be conducted through publication in peer-reviewed journals and through scientific conferences.Trial registration numberTrial register identifier: Netherlands Trial register Trial NL7897. Date of registration: 24 July 2019. https://www.trialregister.nl/trial/7897.

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