Efficacy and toxicity according to hormone therapy used in the CHHiP trial.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 316-316 ◽  
Author(s):  
Alison Tree ◽  
Clare Griffin ◽  
Emma Hall ◽  
David P. Dearnaley ◽  
Keyword(s):  
Erectile Function ◽  
Cox Regression ◽  
Controlled Trial ◽  
Similar Efficacy ◽  
Trend Test ◽  
Chi Square ◽  
Patient Reported ◽  
Toxicity Analysis ◽  
Randomised Controlled

316 Background: CHHiP (CRUK/06/016) is a multicentre randomised controlled trial which investigated the use of moderately hypofractionated radiotherapy (RT) dose schedules for treatment of localised prostate cancer. 97% of participants (pts) had concurrent androgen deprivation therapy (ADT). Luteinising Hormone Releasing Hormone analogues (LHRHa) and bicalutamide 150mg (BIC) daily were permitted. This exploratory analysis investigates whether both ADT regimens show similar efficacy and whether BIC has the propensity to preserve erectile function. Methods: In CHHiP, 2700 pts received LHRH and 403 BIC, median duration 5.6 months. The primary endpoint was biochemical or clinical failure (BCF). ADT groups were compared with Cox regression adjusted forage, NCCN risk group, Gleason score,T-stage and stratified by RT dose. A key secondary endpoint was erectile function assessed by clinicians (LENTSOM subjective erectile function for vaginal penetration score) and pts (single items within UCLA-PCI and EPIC-50 questionnaires) at 2 years. 195/875 (22%) pts were excluded from this toxicity analysis as they had erectile dysfunction pre-ADT (grade (G) 3/4 LENTSOM). A chi square trend test compared ADT regimens. Results: Baseline demographics were similar except BIC pts were significantly younger (median 67 years BIC, 69 years LHRHa). With a median follow-up of 9.2 years, there was no evidence of a difference in BCF with an adjusted hazard ratio 0.95 (95% CI 0.75-1.20), p = 0.657. Eight year BCF rates were 80.7% (95%CI 79.0-82.2) and 80.3% (95%CI 75.8-84.0) for LHRHa and BIC pts respectively. At two years, LENTSOM erectile function was significantly worse (p < 0.0001) for LHRHa pts with 93/585 (16%), 95/585 (16%) and 125/585 (21%) G2, G3 and G4, compared to 3/68 (4%), 5/68 (7%) and 9/68 (13%) in BIC. At 2 years, the ability to have an erection, as reported by pts, was graded poor and very poor in 73/278 (26%) and 57/278 (21%) LHRHa pts and 5/23 (22%) and 4/23 (17%) in BIC pts (p = 0.584). Conclusions: There was no evidence of a difference in efficacy according to ADT received. BIC preserved clinician assessed (LENTSOM) erectile function at 2 years but patient reported outcomes did not show statistically significant differences with type of ADT. Clinical trial information: 97182923.

scholarly journals Comparison of endoscopic ultrasound-guided hepaticogastrostomy and the antegrade technique: study protocol for a prospective, multicentre, randomised controlled trial

2019 ◽  
Author(s):  
Ye Liao ◽  
Tingyue Xiao ◽  
Shiyun Sheng ◽  
Yufan Wu ◽  
Jingjing Zhang ◽  
...  
Keyword(s):  
Endoscopic Ultrasound ◽  
Cox Regression ◽  
Controlled Trial ◽  
Rank Test ◽  
Ultrasound Guided ◽  
Clinical Trial Registry ◽  
Chi Square ◽  
Cox Regression Analysis ◽  
Chi Square Test ◽  
Randomised Controlled

Abstract Background: Endoscopic ultrasound-guided biliary drainage (EUS-BD) is used after failed endoscopic retrograde cholangiopancreatography. Based on existing studies, intrahepatic (IH) approaches are suggested to be preferred in patients with a dilated IH bile duct. Both ultrasound-guided hepaticogastrostomy (EUS-HGS) and ultrasound-guided antegrade treatment (EUS-AG) are available IH approaches for patients with an unreachable papilla. However, a direct comparison between these two approaches is lacking. Therefore, we aim to evaluate and compare the safety and efficiency of EUS-HGS and EUS-AG in patients with an unreachable papilla. Methods: This is a prospective, randomised, controlled, multicentre study. One-hundred forty-eight patients from three hospitals who met the inclusion criteria will be randomly assigned (1:1) to undergo either EUS-HGS or EUS-AG for relief of biliary obstruction. The final study follow-up is scheduled at 1 year postoperatively. The primary endpoint is to compare the safety and efficiency of EUS-HGS and EUS-AG in patients with an unreachable papilla. The secondary endpoint is the overall survival rate of patients undergoing EUS-HGS and EUS-AG. The chi-square test, Kaplan-Meier methods, the log-rank test, and Cox regression analysis will be used to analyse the data. Discussion: To our knowledge, this is the first study to compare these two EUS-BD approaches directly using a multicentre, randomized, controlled trial design. The clinical economic indexes will also be compared, as they may also affect the patient’s choice. The result may contribute to establishing a strategic guideline for choosing IH EUS-BD approaches. Trial registration: Chinese Clinical Trial Registry (ChiCTR), ChiCTR1900020737; registered on 15 January 2019. http://www.chictr.org.cn/showproj.aspx?proj=33672

scholarly journals Quit attempts and tobacco abstinence in primary care patients: long-term follow-up of a pragmatic, two-arm cluster randomised controlled trial on brief stop-smoking advice (ABC versus 5As method)

2021 ◽  
Author(s):  
Sabrina Kastaun ◽  
Wolfgang Viechtbauer ◽  
Verena Leve ◽  
Jaqueline Hildebrandt ◽  
Christian Funke ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Outcome Data ◽  
Cluster Randomised ◽  
Stop Smoking ◽  
Patient Reported ◽  
Quit Attempts ◽  
Randomised Controlled

We developed a 3.5-h-training for general practitioners (GPs) in delivering brief stop-smoking advice according to different methods (ABC, 5As). In a pragmatic, cluster randomised controlled trial our training proved effective in increasing GP-delivered rates of such advice. In this follow-up analysis we examined the effect of ABC and 5As on patient-reported quit attempts and point prevalence abstinence at weeks 4, 12, and 26 following GP consultation. Follow-up data were collected by questionnaires delivered to 1,937 smoking patients recruited before or after the training in which 69 GPs participated. At week 26, ~70% of the patients were lost to follow-up. All 1,937 smoking patients were included in an intention-to-treat analysis. Multiple imputation was used to impute missing outcome data of each follow-up and few missing data of potential confounders. While the receipt of brief GP advice compared to no advice was associated with a two-fold increase in patients' attempts to quit at each follow-up and abstinence at week 26, quit attempts and abstinence rates did not differ significantly from pre- to post-training or between patients from the ABC versus the 5As group. We previously reported that our training increases patient-reported rates of GP-delivered stop-smoking advice. The present follow-up analysis did not show that patients more often attempted or achieved to quit when they received advice from a trained vs. untrained GP. Future training studies should take contextual factors into account - such as access to free evidence-based cessation treatment - which might hamper the transfer of GPs' effective advice into patients' behaviour change.

scholarly journals Design, planning and implementation lessons learnt from a surgical multi-centre randomised controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Katie Biggs ◽  
Daniel Hind ◽  
Mike Bradburn ◽  
Lizzie Swaby ◽  
Steve Brown
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Surgical Interventions ◽  
Surgical Trial ◽  
Patient Reported ◽  
Timely Fashion ◽  
Reported Data ◽  
Randomised Controlled ◽  
Recruitment Target

Abstract Background Increasingly, pragmatic randomised controlled trials are being used to evaluate surgical interventions, although they present particular difficulties in regards to recruitment and retention. Methods Procedures and processes related to implementation of a multi-centre pragmatic surgical randomised controlled trial are discussed. In this surgical trial, forecasting of consent rates based on similar trials and micro-costing of study activities with research partners were undertaken and a video was produced targeting recruiting staff with the aim of aiding recruitment. The baseline assessments were reviewed to ensure the timing did not impact on the outcome. Attrition due to procedure waiting time was monitored and data were triangulated for the primary outcome to ensure adequate follow-up data. Results Forecasting and costing ensured that the recruitment window was of adequate length and adequate resource was available for study procedures at multiple clinics in each hospital. Recruiting staff found the recruitment video useful. The comparison of patient-reported data collected prior to randomisation and prior to treatment provided confidence in the baseline data. Knowledge of participant dropout due to delays in treatment meant we were able to increase the recruitment target in a timely fashion, and along with the triangulation of data sources, this ensured adequate follow-up of randomised participants. Conclusions This paper provides a range of evidence-based and experience-based approaches which, collectively, resulted in meeting our study objectives and from which lessons may be transferable. Trial registration ISRCTN, ISRCTN41394716. Registered on 10 May 2012. UKCRN Study ID: 12486.

scholarly journals Quit attempts and tobacco abstinence in primary care patients: follow-up of a pragmatic, two-arm cluster randomised controlled trial on brief stop-smoking advice (ABC versus 5As)

2021 ◽  
pp. 00224-2021
Author(s):  
Sabrina Kastaun ◽  
Wolfgang Viechtbauer ◽  
Verena Leve ◽  
Jaqueline Hildebrandt ◽  
Christian Funke ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Outcome Data ◽  
Cluster Randomised ◽  
Stop Smoking ◽  
Patient Reported ◽  
Quit Attempts ◽  
Randomised Controlled

We developed a 3.5 h-training for general practitioners (GPs) in delivering brief stop-smoking advice according to different methods (ABC, 5As). In a pragmatic, cluster randomised controlled trial our training proved effective in increasing GP-delivered rates of such advice (from 13% to 33%). In this follow-up analysis we examined the effect of the training and compared ABC versus 5As on patient-reported quit attempts and point prevalence abstinence at weeks 4, 12, and 26 following GP consultation.Follow-up data were collected in 1937 smoking patients – independently of the receipt of GP advice – recruited before or after the training of 69 GPs. At week 26, ∼70% of the patients were lost to follow-up. All 1937 patients were included in an intention-to-treat analysis; missing outcome data were imputed.Quit attempts and abstinence rates did not differ significantly from pre- to post-training or between patients from the ABC versus the 5As group. However, ancillary analyses showed that patients who received GP advice compared to those who did not, had two times higher odds of reporting a quit attempt at all follow-ups and abstinence at week 26.We reported that our training increases GP-delivered rates of stop-smoking advice, and the present analysis confirms that advice is associated with increased quit attempts and abstinence rates in patients. However, our training did not further improve these rates, which might be related to patients’ loss to follow-up or to contextual factors – e.g., access to free evidence-based cessation treatment – which can hamper the transfer of GPs’ advice into patients’ behaviour change.

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