scholarly journals Randomised controlled trial of the impact of haemodiafiltration on uraemic neuropathy: FINESSE study protocol

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e023736
Author(s):  
Brendan Smyth ◽  
Arun V Krishnan ◽  
Martin Gallagher ◽  
Matthew Kiernan ◽  
Paul Snelling ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Randomised Trial ◽  
Cumulative Exposure ◽  
Open Label ◽  
Middle Molecules ◽  
Show Evidence ◽  
The Difference ◽  
Randomised Controlled ◽  
End Stage ◽  
The Impact

IntroductionThe majority of patients undergoing haemodialysis (HD) show evidence of uraemic neuropathy, a condition with no known disease-modifying treatments. The pathogenesis of uraemic neuropathy is poorly understood, but may be related to cumulative exposure to middle molecules or other solutes such as potassium. It is not known whether haemodiafiltration (HDF) reduces the progression of uraemic neuropathy.Methods and analysisFiltration In the Neuropathy of End-Stage kidney disease Symptom Evolution (FINESSE) is a multicentre, randomised, open-label, blinded endpoint assessment, controlled trial designed to assess the impact of HDF versus HD on uraemic neuropathy. Maintenance HD patients will be randomised in a 1:1 ratio to receive HDF or HD with high-flux membranes for 4 years. The primary endpoint is the difference in the mean change in Total Neuropathy Score (TNS)—a measure of peripheral neuropathy combining symptoms, signs and nerve conduction velocity—over the study period. Secondary outcomes include change at annual timepoints in the TNS and the Neuropathy Symptom Score; and in morbidity, mortality and safety events.Ethics and disseminationThe FINESSE trial has been approved by the Ethics Review Committee of the Sydney South West Area Health Service (HREC/09/RPAH/268) and of Adventist HealthCare Limited (2012–027). When published in a peer-reviewed journal, it will be the largest and longest reported randomised trial aimed at reducing the incidence and severity of uraemic neuropathy. It will advance the understanding of the natural history of uraemic neuropathy and the influence of convective therapies on both neurophysiological and clinical outcomes. It will also allow refinement of current hypotheses surrounding the pathogenesis of uraemic neuropathy and, most importantly, may lead to improvements in the lives of the many patients affected by this debilitating condition.Trial registration numberACTRN12609000615280.

scholarly journals Randomised Trial of Lipiodol Uterine Bathing Effect (LUBE) in Women with Endometriosis-Related Infertility

2019 ◽  
Vol 01 (01) ◽  
pp. 57-64 ◽  
Author(s):  
N.P. Johnson ◽  
S. Baidya ◽  
S.O. Jessup ◽  
C.G. Print ◽  
A. Muthukaruppan ◽  
...  
Keyword(s):  
Gene Expression ◽  
Controlled Trial ◽  
Quantitative Polymerase Chain Reaction ◽  
Embryo Implantation ◽  
Randomised Trial ◽  
Polymerase Chain Reaction Analysis ◽  
Endometrial Biopsy ◽  
Open Label ◽  
Randomised Controlled ◽  
Sampling Procedures

BACKGROUND: We aimed to assess whether lipiodol alters endometrial gene expression through a uterine bathing effect that might enhance receptivity to embryo implantation. METHODS: An open-label randomised controlled trial design in a single-centre tertiary infertility service. Twelve women with endometriosis (n [Formula: see text] 11) or previous successful lipiodol procedure (n [Formula: see text] 1) were randomised to receive immediate or delayed lipiodol hysterosalpingography, followed by endometrial biopsy. Endometrial samples were assessed for gene expression, using Affymetrix microarrays and validation studies using reverse transcriptase quantitative polymerase chain reaction analysis. Subsequent endometrial gene expression responses to treatment and clinical fertility outcomes were assessed. RESULTS: Eleven of 12 women had successful endometrial sampling procedures. Nine women had successful pregnancies within the 9-month follow-up phase. Following lipiodol bathing we identified 20 down-regulated and 13 up-regulated genes with p [Formula: see text] 0.05 and with magnitude of change [Formula: see text]1.5-fold in at least three of the four women, with osteopontin being the only gene down-regulated in all four women. CONCLUSIONS: This study supports the concept of a uterine bathing effect of lipiodol altering endometrial biology and gene expression. Whether regulation of inflammation and immune response pathways by lipiodol might contribute to an increase in endometrial receptivity to embryo implantation merits further investigation.

scholarly journals Protocol for a randomised, open-label, parallel group, multicentre controlled study to evaluate the clinical performance and safety of Stay Safe Link compared with Stay Safe in patients with end-stage kidney disease on continuous ambulatory peritoneal dialysis

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e024589
Author(s):  
Wen Yao Mak ◽  
Loke Meng Ong ◽  
Bak Leong Goh ◽  
Sunita Bavanandan ◽  
Lily Mushahar ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Randomised Controlled Trial ◽  
Continuous Ambulatory Peritoneal Dialysis ◽  
Controlled Trial ◽  
Intervention Group ◽  
Controlled Study ◽  
Control Group ◽  
Open Label ◽  
Randomised Controlled ◽  
End Stage

IntroductionPeritonitis is a major complication of continuous ambulatory peritoneal dialysis (CAPD), the risk of which is significantly influenced by the type of PD transfer system. Although the Y-disconnect and double-bag system is more efficient in preventing peritonitis compared with the spike system, little information is available to differentiate risks between different brands of the Y-disconnect double-bag system. A randomised controlled trial to evaluate the safety and efficacy of a newly introduced system is needed to provide the necessary clinical evidence to guide policy decision-making.Methods and analysisThe study is an open-label randomised controlled trial. A total of 434 patients with end-stage renal disease undergoing CAPD will be enrolled and randomised to either the intervention group, Stay Safe Link, or the control group, Stay Safe. All study subjects will be followed up and monitored for 1 year. The primary safety outcome is the rate of peritonitis while the primary efficacy outcomes are the delivered dialysis dose and ultrafiltration volume.Ethics and disseminationThe study was approved by the Medical Research Ethics Committee, National Institute of Health Malaysia. A written informed consent will be obtained from all participating subjects prior to any trial-related procedure and the study conduct will adhere strictly to Good Clinical Practice. The findings will be disseminated in a peer-reviewed journal.Trial registration numberNCT03177031; Pre-results.

scholarly journals Feasibility & Efficacy of Deprescribing rounds in a Singapore rehabilitative hospital- a randomised controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Andrew Peng Yong Wong ◽  
Tan Wan Ting ◽  
Ee Jia Ming Charissa ◽  
Tan Wee Boon ◽  
Kwan Yu Heng ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Multidisciplinary Team ◽  
Controlled Trial ◽  
Total Daily Dose ◽  
Open Label ◽  
Rehabilitation Hospital ◽  
Link Type ◽  
Randomised Controlled ◽  
The Impact

Abstract Background Deprescribing is effective and safe in reducing polypharmacy among the elderly. However, the impact of deprescribing rounds remain unclear in Asian settings. Hence, we conducted this study. Methods An open label randomised controlled trial was conducted on patients of 65 years and above, under rehabilitation or subacute care and with prespecified medications from a Singapore rehabilitation hospital. They were randomised using a computer generated sequence. The intervention consisted of weekly multidisciplinary team-led deprescribing rounds (using five steps of deprescribing) and usual care. The control had only usual care. The primary outcome is the percentage change in total daily dose (TDD) from baseline upon discharge, while the secondary outcomes are the total number of medicine, total daily cost and TDD up to day 28 postdischarge, overall side-effect rates, rounding time and the challenges. Efficacy outcomes were analysed using intention-to-treat while other outcomes were analysed as per protocol. Results 260 patients were randomised and 253 were analysed after excluding dropouts (female: 57.3%; median age: 76 years). Baseline characteristics were largely similar in both groups. The intervention arm (n = 126) experienced a greater reduction of TDD on discharge [Median (IQR): − 19.62% (− 34.38, 0.00%) versus 0.00% (− 12.00, 6.82%); p < 0.001], more constipation (OR: 3.75, 95% CI:1.75–8.06, p < 0.001) and laxative re-prescriptions (OR: 2.82, 95% CI:1.30–6.12, p = 0.009) though death and hospitalisation rates were similar. The median rounding time was 7.09 min per patient and challenges include the inconvenience in assembling the multidisciplinary team. Conclusion Deprescribing rounds can safely reduce TDD of medicine upon discharge compared to usual care in a Singaporean rehabilitation hospital. Trial registration This study is first registered at Clinicaltrials.gov (protocol number: NCT03713112) on 19/10/2018 and the protocol can be accessed on https://www.clinicaltrials.gov.

scholarly journals Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial

2020 ◽  
Vol 6 (4) ◽  
pp. 00460-2020
Author(s):  
Michael G. Crooks ◽  
Jack Elkes ◽  
William Storrar ◽  
Kay Roy ◽  
Mal North ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Usual Care ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Small Sample ◽  
Self Management ◽  
Open Label ◽  
Management Interventions ◽  
Randomised Controlled ◽  
The Impact

Self-management interventions in COPD aim to improve patients' knowledge, skills and confidence to make correct decisions, thus improving health status and outcomes. myCOPD is a web-based self-management app known to improve inhaler use and exercise capacity in individuals with more severe COPD.We explored the impact of myCOPD in patients with mild–moderate or recently diagnosed COPD through a 12-week, open-label, parallel-group, randomised controlled trial of myCOPD compared with usual care. The co-primary outcomes were between-group differences in mean COPD assessment test (CAT) score at 90 days and critical inhaler errors. Key secondary outcomes were app usage and patient activation measurement (PAM) score.Sixty patients were randomised (29 myCOPD, 31 usual care). Groups were balanced for forced expiratory volume in 1 s (FEV1 % pred) but there was baseline imbalance between groups for exacerbation frequency and CAT score. There was no significant adjusted mean difference in CAT score at study completion, −1.27 (95% CI −4.47–1.92, p=0.44) lower in myCOPD. However, an increase in app use was associated with greater CAT score improvement. The odds of ≥1 critical inhaler error was lower in the myCOPD arm (adjusted OR 0.30 (95% CI 0.09–1.06, p=0.061)). The adjusted odds ratio for being in a higher PAM level at 90 days was 1.65 (95% CI 0.46–5.85) in favour of myCOPD.The small sample size and phenotypic difference between groups limited our ability to demonstrate statistically significant evidence of benefit beyond inhaler technique. However, our findings provide important insights into associations between increased app use and clinically meaningful benefit warranting further study in real world settings.

scholarly journals Pain Squad+ smartphone app to support real-time pain treatment for adolescents with cancer: protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e037251
Author(s):  
Lindsay Jibb ◽  
Paul C Nathan ◽  
Vicky Breakey ◽  
Conrad Fernandez ◽  
Donna Johnston ◽  
...  
Keyword(s):  
Real Time ◽  
Pain Treatment ◽  
Controlled Trial ◽  
Qualitative Interviews ◽  
Randomised Trial ◽  
Control Group ◽  
Management Support ◽  
Scientific Meetings ◽  
Randomised Controlled ◽  
The Impact

IntroductionPain negatively affects the health-related quality of life (HRQL) of adolescents with cancer. The Pain Squad+ smartphone-based application (app), has been developed to provide adolescents with real-time pain self-management support. The app uses a validated pain assessment and personalised pain treatment advice with centralised decision support via a registered nurse to enable real-time pain treatment in all settings. The algorithm informing pain treatment advice is evidence-based and expert-vetted. This trial will longitudinally evaluate the impact of Pain Squad+, with or without the addition of nurse support, on adolescent health and cost outcomes.Methods and analysisThis will be a pragmatic, multicentre, waitlist controlled, 3-arm parallel-group superiority randomised trial with 1:1:1 allocation enrolling 74 adolescents with cancer per arm from nine cancer centres. Participants will be 12 to 18 years, English-speaking and with ≥3/10 pain. Exclusion criteria are significant comorbidities, end-of-life status or enrolment in a concurrent pain study. The primary aim is to determine the effect of Pain Squad+, with and without nurse support, on pain intensity in adolescents with cancer, when compared with a waitlist control group. The secondary aims are to determine the immediate and sustained effect over time of using Pain Squad+, with and without nurse support, as per prospective outcome measurements of pain interference, HRQL, pain self-efficacy and cost. Linear mixed models with baseline scores as a covariate will be used. Qualitative interviews with adolescents from all trial arms will be conducted and analysed.Ethics and disseminationThis trial is approved by the Hospital for Sick Children Research Ethics Board. Results will provide data to guide adolescents with cancer and healthcare teams in treating pain. Dissemination will occur through partnerships with stakeholder groups, scientific meetings, publications, mass media releases and consumer detailing.Trial registration numberNCT03632343(ClinicalTrials.gov).

scholarly journals Protocol for a multicentre randomised controlled parallel-group trial to compare the effectiveness of remotely delivered cognitive-behavioural and graded exercise interventions with usual care alone to lessen the impact of fatigue in inflammatory rheumatic diseases (LIFT)

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e026793 ◽  
Author(s):  
Kathryn R Martin ◽  
Eva-Maria Bachmair ◽  
Lorna Aucott ◽  
Emma Dures ◽  
Richard Emsley ◽  
...  
Keyword(s):  
Rheumatic Diseases ◽  
Controlled Trial ◽  
Scientific Journal ◽  
Randomised Trial ◽  
Inflammatory Rheumatic Diseases ◽  
Exercise Interventions ◽  
Cognitive Behavioural ◽  
Graded Exercise ◽  
Randomised Controlled ◽  
The Impact

IntroductionFatigue remains pervasive, disabling and challenging to manage across all inflammatory rheumatic diseases (IRDs). Non-pharmacological interventions, specifically cognitive-behavioural approaches (CBAs) and graded exercise programmes designed to support and increase exercise, are valuable treatments which help patients with IRD to manage their fatigue. Yet, healthcare systems have encountered substantial barriers to the implementation of these therapeutic options. Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases: a Randomised Trial (LIFT) is designed to give insights into the effectiveness of a remotely delivered standardised intervention for a range of patients with IRD. It will also enable the exploration of putative moderating factors which may allow for the future triage of patients and to investigate the precise mediators of treatment effect in IRD-related fatigue.Methods and analysisLIFT is a pragmatic, multicentre, three-arm randomised, controlled trial, which will test whether adapted CBA and personalised exercise programme interventions can individually reduce the impact and severity of fatigue. This will be conducted with up to 375 eligible patients diagnosed with IRD and interventions will be delivered by rheumatology healthcare professionals, using the telephone or internet-based audio/video calls.Ethics approval and disseminationEthical approval has been granted by Wales REC 7 (17/WA/0065). Results of this study will be disseminated through presentation at scientific conferences and in scientific journal. A lay summary of the results will be sent to participants.Trial registration numberNCT03248518; Pre-results.

scholarly journals Trials of transvaginal mesh devices for pelvic organ prolapse: a systematic database review of the US FDA approval process

BMJ Open ◽  
2017 ◽  
Vol 7 (12) ◽  
pp. e017125 ◽  
Author(s):  
Carl J Heneghan ◽  
Ben Goldacre ◽  
Igho Onakpoya ◽  
Jeffrey K Aronson ◽  
Tom Jefferson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Pelvic Organ Prolapse ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Pelvic Organ ◽  
Transvaginal Mesh ◽  
Safety Studies ◽  
The Usa ◽  
Randomised Controlled ◽  
The Impact

IntroductionTransvaginal mesh devices are approved in the USA by the Food and Drug Administration (FDA), through the 510(k) system. However, there is uncertainty about the benefit to harm balance of mesh approved for pelvic organ prolapse. We, therefore, assessed the evidence at the time of approval for transvaginal mesh products and the impact of safety studies the FDA mandated in 2012 because of emerging harms.MethodsWe used FDA databases to determine the evidence for approval of transvaginal mesh. To create a ‘family tree’ of device equivalence, we used the 510(k) regulatory approval of the 1985 Mersilene Mesh (Ethicon) and the 1996 ProteGen Sling (Boston Scientific), searched for all subsequently related device approvals, and for the first published randomised trial evidence. We assessed compliance with all FDA 522 orders issued in 2012 requiring postmarketing surveillance studies.ResultsWe found 61 devices whose approval ultimately relied on claimed equivalence to the Mersilene Mesh and the ProteGen Sling. We found no clinical trials evidence for these 61 devices at the time of approval. Publication of randomised clinical trials occurred at a median of 5 years after device approval (range 1–14 years). Analysis of 119 FDA 522 orders revealed that in 79 (66%) the manufacturer ceased market distribution of the device, and in 26 (22%) the manufacturer had changed the indication. Only seven studies (six cohorts and new randomised controlled trial) covering 11 orders were recruiting participants (none had reported outcomes).ConclusionsTransvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years. Devices have inherited approval status from a few products. A publicly accessible registry of licensed invasive devices, with details of marketing status and linked evidence, should be created and maintained at the time of approval.

scholarly journals Total or partial tonsillar resection (tonsillectomy or tonsillotomy) to change the quality of life for adults with recurrent or chronic tonsillitis: study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aleksi Laajala ◽  
Paulus Tokola ◽  
Timo J. Autio ◽  
Timo Koskenkorva ◽  
Mikko Tastula ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Chronic Tonsillitis ◽  
Recurrent Tonsillitis ◽  
New Information ◽  
Parallel Group ◽  
The Difference ◽  
Randomised Controlled

Abstract Background Tonsillar surgery has been used for decades to treat recurrent and chronic tonsillitis in adults. Recurrent and chronic tonsillitis result in disturbing symptoms, treatment costs, sick leave, and impaired quality of life (QoL). Theoretically, removing all or part of the altered pathological palatal lymphoid tissue alleviates the symptoms and enhances the QoL. Whether this is true with total or partial tonsillar resection (tonsillectomy (TE) and tonsillotomy (TT), respectively) has not been reported in a randomised trial yet. Methods We conduct a multicentre, partly blinded, randomised, 6-month, parallel-group clinical study including 285 adult participants referred to surgical treatment for chronic or recurrent tonsillitis. The participants will either have TE, TT or watchful waiting (WW). The primary outcome will be the difference between the mean disease-specific Tonsillectomy Outcome Inventory-14 (QoL questionnaire) scores at 6 months. Comparison is made firstly between the combined TE+TT and WW groups (superiority analysis), and secondly between the TE and TT groups (non-inferiority analysis). Discussion This study will add significant new information to the effects and harms of TE and TT procedures in the treatment of adults with chronic or recurrent tonsillitis. Trial registration ClinicalTrials.gov: NCT04657549

Sign in / Sign up

Export Citation Format

Share Document