ResearchPad - 1738 https://www.researchpad.co Default RSS Feed en-us © 2020 Newgen KnowledgeWorks <![CDATA[Does Gleason score of positive surgical margin after radical prostatectomy affect biochemical recurrence and oncological outcomes? Protocol for systematic review]]> https://www.researchpad.co/article/N0960b75d-51f4-4ece-bdf9-1b092938e960 Positive surgical margins (PSM) in cancer patients are commonly associated with worse prognosis and a higher risk of secondary treatment. However, the relevance of this parameter in prostate cancer patients undergoing radical prostatectomy (RP) remains controversial, given the inconsistencies in its ability to predict biochemical recurrence (BCR) and oncological outcomes. Hence, further assessment of the utility of surgical margins for prostate cancer prognosis is required to predict these outcomes more accurately. Over the last decade, studies have used the Gleason score (GS) of positive margins to predict outcomes. Herein, the authors aim to conduct a systematic review investigating the role of GS of PSM after radical prostatectomy in predicting BCR and oncological outcomes.Methods and analysisWe will perform a search using MEDLINE, EMBASE, SCOPUS and COCHRANE databases. The review will be reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We will screen titles and abstracts to select articles appropriate for full-text review. Studies discussing GS of PSM after RP will be included. Given the change in reporting of GS, only articles from 2005 to 2019 will be included. The quality of the studies chosen will be assessed using the Newcastle Ottawa tool for non-randomised and Cochrane risk of bias for randomised control studies. We will adopt the grading of recommendations, assessment, development and evaluation framework to comment on quality of cumulative evidence. The primary outcome measure will be time to BCR. Secondary outcome measures include secondary treatment, disease-specific survival, disease progression-free and overall mortality at follow-up period. We aim to perform a meta-analysis if the level of heterogeneity is acceptable (I2 <50%).Ethics and disseminationThe review does not require ethics approval as it is a review of published literature. The findings of the review will be submitted for peer-reviewed publications and presented at scientific meetings.PROSPERO registration numberCRD42019131800. ]]> <![CDATA[Complications after surgery for benign prostatic enlargement: a population-based cohort study in Ontario, Canada]]> https://www.researchpad.co/article/Nddf5c33e-b769-4b47-8d1a-6de48b48344c

Objectives

To examine the complication rates after benign prostatic enlargement (BPE) surgery and the effects of age, comorbidity and preoperative medical therapy.

Design

A retrospective, population-based cohort study using linked administrative data.

Setting

Ontario, Canada.

Participants

52 162 men≥66 years undergoing first BPE surgery between 1 January 2003 to 31 December 2014.

Intervention

Medical therapy preoperatively and surgery for BPE.

Primary and secondary outcome measures

The primary outcome was overall 30-day postoperative complication rates. Secondary outcomes included BPE-specific event rates (bleeding, infection, obstruction, trauma) and non-BPE specific event rates (cardiovascular, pulmonary, thromboembolic and renal). Multivariable analysis examined the association between preoperative medical therapy and postoperative complication rates.

Results

The 30-day overall complication rate after BPE surgery was 2828 events/10 000 procedures and increased annually over the study period. Receipt of preoperative α-blocker monotherapy (relative rate (RR) 1.05; 95% CI 1.00 to 1.09; p=0.033) and antithrombotic medications (RR 1.27; 95% CI 1.22 to 1.31; p<0.0001) was associated with increased complication rates. Among the ≥80-year-old group, the rate of complications increased by 39% from 2003 to 2014 (RR 1.39; 95% CI 1.21 to 1.61; p<0.0001). The mean duration of medical and conservative management increased by a mean of 2.1 years between 2007 and 2014 (p<0.0001 for trend).

Conclusions

Thirty-day complication rates after BPE surgery have increased annually between 2003 and 2014. Preoperative medical therapy with alpha blockers or antithrombotics was independently associated with higher rates of complications. Over this time, the duration of conservative therapy also increased.

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<![CDATA[Phase II randomised control feasibility trial of a nutrition and physical activity intervention after radical prostatectomy for prostate cancer]]> https://www.researchpad.co/article/N85e31e29-b60a-4d4a-a57c-ea5b0b124cc9

Objective

Dietary factors and physical activity may alter prostate cancer progression. We explored the feasibility of lifestyle interventions following radical prostatectomy for localised prostate cancer.

Design

Patients were recruited into a presurgical observational cohort; following radical prostatectomy, they were offered randomisation into a 2×3 factorial randomised controlled trial (RCT).

Setting

A single National Health Service trust in the South West of England, UK.

Participants

Those with localised prostate cancer and listed for radical prostatectomy were invited to participate.

Randomisation

Random allocation was performed by the Bristol Randomised Trial Collaboration via an online system.

Interventions

Men were randomised into both a modified nutrition group (either increased vegetable and fruit, and reduced dairy milk; or lycopene supplementation; or control) and a physical activity group (brisk walking or control) for 6 months.

Blinding

Only the trial statistician was blind to allocations.

Primary outcome measures

Primary outcomes were measures of feasibility: randomisation rates and intervention adherence at 6 months. Collected at trial baseline, three and six months, with daily adherence reported throughout. Our intended adherence rate was 75% or above, the threshold for acceptable adherence was 90%.

Results

108 men entered the presurgical cohort, and 81 were randomised into the postsurgical RCT (randomisation rate: 93.1%) and 75 completed the trial. Of 25 men in the nutrition intervention, 10 (40.0%; 95% CI 23.4% to 59.3%) adhered to the fruit and vegetable recommendations and 18 (72.0%; 95% CI 52.4% to 85.7%) to reduced dairy intake. Adherence to lycopene (n=28), was 78.6% (95% CI 60.5% to 89.8%), while 21/39 adhered to the walking intervention (53.8%; 95% CI 38.6% to 68.4%). Most men were followed up at 6 months (75/81; 92.6%). Three ‘possibly related’ adverse events were indigestion, abdominal bloating and knee pain.

Conclusions

Interventions were deemed feasible, with high randomisation rates and generally good adherence. A definitive RCT is proposed.

Trial registration number

ISRCTN 99048944.

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<![CDATA[Moxibustion as an adjuvant for benign prostatic hyperplasia with lower urinary tract symptoms: a protocol for a parallel-group, randomised, controlled pilot trial]]> https://www.researchpad.co/article/5af66f0f463d7e44c8bd73b3

Introduction

This study aims to explore the feasibility of using moxibustion as a supplementary intervention and to assess the sample size for verifying the effectiveness and safety of integrative treatment involving moxibustion compared with conventional treatment for patients with benign prostatic hyperplasia accompanying moderate to severe lower urinary tract symptoms.

Methods and analysis

A total of 60 patients diagnosed with benign prostatic hyperplasia by a urologist based on prostate size, prostate-specific antigen and clinical symptoms will participate of their own free will; urologists will monitor the patients and evaluate their symptoms. The patients will be randomised to either a conventional group or an integrative group with a 1:1 allocation according to computer-generated random numbers concealed in opaque, sealed, sequentially numbered envelopes. Watchful waiting or oral medication including α blocker, 5α-reductase inhibitors or antimuscarinic drugs will be offered as conventional treatment. Integrative treatment will include moxibustion therapy in addition to the conventional treatment. The moxibustion therapy will be conducted twice a week for 4 weeks on the bilateral acupoints SP6, LR3 and CV4 by a qualified Korean medical doctor. The primary outcome will be the International Prostate Symptom Score (IPSS) after eight sessions. The secondary outcomes will be the post-void residual urine volume, the maximum urinary flow rate, IPSS, the results of a Short-Form 36-Question Health Survey after 12 weeks, and the patients’ global impression of changes at each visit.

Ethics and dissemination

Written informed consent will be obtained from all participants. This study was approved by the institutional review boards of both Pusan National University Yangsan Hospital and Pusan National University Korean Medicine Hospital. The trial results will be disseminated through open-access journals and conferences.

Trial registration number

NCT02051036.

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<![CDATA[Renal hypothermia during partial nephrectomy for patients with renal tumours: a randomised controlled clinical trial protocol]]> https://www.researchpad.co/article/5c59e0fed5eed0c484111474

Introduction

Partial nephrectomy is a standard of care for non-metastatic renal tumours when technically feasible. Despite the increased use of partial nephrectomy, intraoperative techniques that lead to optimal renal function after surgery have not been rigorously studied. Clamping of the renal hilum to prevent bleeding during resection causes temporary renal ischaemia. The internal temperature of the kidney may be lowered after the renal hilum is clamped (renal hypothermia) in an attempt to mitigate the effects of ischaemia. Our objective is to determine if renal hypothermia during open partial nephrectomy results in improved postoperative renal function at 12 months following surgery as compared with warm ischaemia (no renal hypothermia).

Methods and analyses

This is a multicentre, randomised, single-blinded controlled trial comparing renal hypothermia versus no hypothermia during open partial nephrectomy. Due to the nature of the intervention, complete blinding of the surgical team is not possible; however, surgeons will be blinded until the time of hilar clamping. Glomerular filtration will be based on plasma clearance of a radionucleotide, and differential renal function will be based on renal scintigraphy. The primary outcome is overall renal function at 12 months measured by the glomerular filtration rate (GFR). Secondary outcomes include change in GFR, GFR of the affected kidney, change in GFR of the affected kidney, serum creatinine, haemoglobin, spot urine albumin to creatinine ratio, quality of life and postoperative complications. Data will be collected at baseline, immediately postoperatively and at 3, 6, 9 and 12 months postoperatively.

Ethics and dissemination

Ethics approval was obtained for all participating study sites. Results of the trial will be submitted for publication in a peer-reviewed journal.

Trial registration number

NCT01529658; Pre-results.

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<![CDATA[A Community Jury on PSA screening: what do well-informed men want the government to do about prostate cancer screening—a qualitative analysis]]> https://www.researchpad.co/article/5ad488ba463d7e35b4fbff90

Objective

Cancer screening policies and programmes should take account of public values and concerns. This study sought to determine the priorities, values and concerns of men who were ‘fully informed’ about the benefits and harms of prostate-specific antigen (PSA) screening; and empirically examine the value of a community jury in eliciting public values on PSA screening.

Setting

Community jury was convened on the Gold Coast, Queensland (Australia) to consider PSA screening benefits and harms, and whether government campaigns on PSA screening should be conducted.

Participants

27 men (volunteers) aged 50–70 with no personal history of prostate cancer and willing to attend jury 6–7 April 2013: 12 were randomly allocated to jury (11 attended).

Outcome measures

A qualitative analysis was conducted of the jury deliberations (audio-recorded and transcribed) to elicit the jury's views and recommendations. A survey determined the impact of the jury process on participants’ individual testing decisions compared with control group.

Results

The jury concluded governments should not invest in programmes focused on PSA screening directed at the public because the PSA test did not offer sufficient reassurance or benefit and could raise unnecessary alarm. It recommended an alternative programme to support general practitioners to provide patients with better quality and more consistent information about PSA screening. After the jury, participants were less likely to be tested in the future compared with the controls, but around half said they would still consider doing so.

Conclusions

The jury's unanimous verdict about government programmes was notable in the light of their divergent views on whether or not they would be screened themselves in the future. Community juries provide valuable insights into the priorities and concerns of men weighing up the benefits and harms of PSA screening. It will be important to assess the degree to which the findings are generalisable to other settings.

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<![CDATA[Real-world persistence and adherence to oral antimuscarinics and mirabegron in patients with overactive bladder (OAB): a systematic literature review]]> https://www.researchpad.co/article/5c19b157d5eed0c484c4ca6b

Purpose

To evaluate persistence and adherence of oral pharmacotherapy used in the treatment of overactive bladder (OAB) in a real-world setting.

Materials and methods

Systematic literature searches of six electronic publication databases were performed to identify observational studies of patients with OAB treated with antimuscarinics and/or mirabegron. Studies obtaining persistence and adherence data from sources other than electronic prescription claims were excluded. Reference lists of identified studies and relevant systematic reviews were assessed to identify additional relevant studies.

Results

The search identified 3897 studies, of which 30 were included. Overall, persistence ranged from 5% to 47%. In studies reporting data for antimuscarinics and mirabegron (n=3), 1-year persistence was 12%–25% and 32%–38%, respectively. Median time to discontinuation was <5 months for antimuscarinics (except one study (6.5 months)) and 5.6–7.4 months for mirabegron. The proportion of patients adherent at 1 year varied between 15% and 44%. In studies reporting adherence for antimuscarinics and mirabegron, adherence was higher with mirabegron (mean medication possession ratio (MPR): 0.59 vs 0.41–0.53; mean proportion of days covered: 0.66 vs 0.55; and median MPR: 0.65 vs 0.19–0.49). Reported determinants of persistence and adherence included female (sex), older age group, use of extended-release formulation and treatment experience.

Conclusion

Most patients with OAB discontinued oral OAB pharmacotherapy and were non-adherent 1 year after treatment initiation. In general, mirabegron was associated with greater persistence and adherence compared with antimuscarinics. Combined with existing clinical trial evidence, this real-world review merits consideration of mirabegron for first-line pharmacological treatment among patients with OAB.

PROSPERO registration number

CRD42017059894.

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