scholarly journals Linked Colour imaging for the detection of polyps in patients with Lynch syndrome: a multicentre, parallel randomised controlled trial

Gut ◽  
2021 ◽  
pp. gutjnl-2020-323132
Author(s):  
Britt B S L Houwen ◽  
Yark Hazewinkel ◽  
María Pellisé ◽  
Liseth Rivero-Sánchez ◽  
Francesc Balaguer ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Lynch Syndrome ◽  
Detection Rate ◽  
Precancerous Lesions ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Polyp Detection Rate ◽  
Adenoma Detection ◽  
Significant Difference ◽  
Randomised Controlled

ObjectiveDespite regular colonoscopy surveillance, colorectal cancers still occur in patients with Lynch syndrome. Thus, detection of all relevant precancerous lesions remains very important. The present study investigates Linked Colour imaging (LCI), an image-enhancing technique, as compared with high-definition white light endoscopy (HD-WLE) for the detection of polyps in this patient group.DesignThis prospective, randomised controlled trial was performed by 22 experienced endoscopists from eight centres in six countries. Consecutive Lynch syndrome patients ≥18 years undergoing surveillance colonoscopy were randomised (1:1) and stratified by centre for inspection with either LCI or HD-WLE. Primary outcome was the polyp detection rate (PDR).ResultsBetween January 2018 and March 2020, 357 patients were randomised and 332 patients analysed (160 LCI, 172 HD-WLE; 6 excluded due to incomplete colonoscopies and 19 due to insufficient bowel cleanliness). No significant difference was observed in PDR with LCI (44.4%; 95% CI 36.5% to 52.4%) compared with HD-WLE (36.0%; 95% CI 28.9% to 43.7%) (p=0.12). Of the secondary outcome parameters, more adenomas were found on a patient (adenoma detection rate 36.3%; vs 25.6%; p=0.04) and a colonoscopy basis (mean adenomas per colonoscopy 0.65 vs 0.42; p=0.04). The median withdrawal time was not statistically different between LCI and HD-WLE (12 vs 11 min; p=0.16).ConclusionLCI did not improve the PDR compared with HD-WLE in patients with Lynch syndrome undergoing surveillance. The relevance of findings more adenomas by LCI has to be examined further.Trial registration numberNCT03344289.

scholarly journals Efficacy of nature-based therapy for individuals with stress-related illnesses: randomised controlled trial

2018 ◽  
Vol 213 (1) ◽  
pp. 404-411 ◽  
Author(s):  
Ulrika Karlsson Stigsdotter ◽  
Sus Sola Corazon ◽  
Ulrik Sidenius ◽  
Patrik Karlsson Nyed ◽  
Helmer Bøving Larsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Well Being ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Significant Difference ◽  
Increasing Demand ◽  
Randomised Controlled

BackgroundStress-related illnesses are a major threat to public health, and there is increasing demand for validated treatments.AimsTo test the efficacy of nature-based therapy (NBT) for patients with stress-related illnesses.MethodRandomised controlled trial (ClinicalTrials.gov ID NCT01849718) comparing Nacadia® NBT (NNBT) with the cognitive–behavioural therapy known as Specialised Treatment for Severe Bodily Distress Syndromes (STreSS). In total, 84 participants were randomly allocated to one of the two treatments. The primary outcome measure was the mean aggregate score on the Psychological General Well-Being Index (PGWBI).ResultsBoth treatments resulted in a significant increase in the PGWBI (primary outcome) and a decrease in burnout (the Shirom–Melamed Burnout Questionnaire, secondary outcome), which were both sustained 12 months later. No significant difference in efficacy was found between NNBT and STreSS for primary outcome and secondary outcomes.ConclusionsThe study showed no statistical evidence of a difference between NNBT and STreSS for treating patients with stress-related illnesses.Declaration of interestNone.

BowelScope: Accuracy of Detection Using Endocuff Optimisation of Mucosal Abnormalities (the B-ADENOMA Study): a multicentre, randomised controlled flexible sigmoidoscopy trial

Gut ◽  
2020 ◽  
Vol 69 (11) ◽  
pp. 1959-1965
Author(s):  
Colin J Rees ◽  
Andrew Brand ◽  
Wee Sing Ngu ◽  
Clive Stokes ◽  
Zoe Hoare ◽  
...  
Keyword(s):  
Detection Rate ◽  
Flexible Sigmoidoscopy ◽  
Controlled Trial ◽  
Polyp Detection ◽  
Detection Rates ◽  
Link Type ◽  
Polyp Detection Rate ◽  
Adenoma Detection ◽  
Participant Experience ◽  
Randomised Controlled

ObjectivesAdenoma detection rate (ADR) is an important quality marker at lower GI endoscopy. Higher ADRs are associated with lower postcolonoscopy colorectal cancer rates. The English flexible sigmoidoscopy (FS) screening programme (BowelScope), offers a one-off FS to individuals aged 55 years. However, variation in ADR exists. Large studies have demonstrated improved ADR using Endocuff Vision (EV) within colonoscopy screening, but there are no studies within FS. We sought to test the effect of EV on ADR in a national FS screening population.DesignBowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities was a multicentre, randomised controlled trial involving 16 English BowelScope screening centres. Individuals were randomised to Endocuff Vision-assisted BowelScope (EAB) or Standard BowelScope (SB). ADR, polyp detection rate (PDR), mean adenomas per procedure (MAP), polyp characteristics and location, participant experience, procedural time and adverse events were measured. Comparison of ADR within the trial with national BowelScope ADR was also undertaken.Results3222 participants were randomised (53% male) to receive EAB (n=1610) or SB (n=1612). Baseline demographics were comparable between arms. ADR in the EAB arm was 13.3% and that in the SB arm was 12.2% (p=0.353). No statistically significant differences were found in PDR, MAP, polyp characteristics or location, participant experience, complications or procedural characteristics. ADR in the SB control arm was 3.1% higher than the national ADR.ConclusionEV did not improve BowelScope ADR when compared with SB. ADR in both arms was higher than the national ADR. Where detection rates are already high, EV is unable to improve detection further.Trial registration numbersNCT03072472, ISRCTN30005319 and CPMS ID 33224.

Improving Colorectal Adenoma Detection Rate with Endocuff Vision. Results of the Adenoma Randomised Controlled Trial

2017 ◽  
Vol 152 (5) ◽  
pp. S1313-S1314 ◽  
Author(s):  
Wee Sing Ngu ◽  
Roisin Bevan ◽  
Zacharias P. Tsiamoulos ◽  
Paul Bassett ◽  
Zoe Hoare ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Colorectal Adenoma ◽  
Detection Rate ◽  
Controlled Trial ◽  
Adenoma Detection Rate ◽  
Adenoma Detection ◽  
Randomised Controlled

scholarly journals Telephone-Delivered Dietary Intervention in Patients with Age-Related Macular Degeneration: 3-Month Post-Intervention Findings of a Randomised Controlled Trial

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 3083
Author(s):  
Diana Tang ◽  
Paul Mitchell ◽  
Gerald Liew ◽  
George Burlutsky ◽  
Victoria M. Flood ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Macular Degeneration ◽  
Controlled Trial ◽  
Age Related Macular Degeneration ◽  
Leafy Vegetables ◽  
Secondary Outcome ◽  
Post Intervention ◽  
Age Related ◽  
Significant Difference ◽  
Randomised Controlled

There is an evidence–practice gap between the dietary recommendations for age-related macular degeneration (AMD) presented in the literature and those practiced by patients. This study reports on the 3-month post-intervention results of a randomised controlled trial (RCT) evaluating telephone-delivered counselling to improve dietary behaviours among AMD patients. A total of 155 AMD patients (57% female, aged 78 ± 8 years; control: 78, intervention: 77), primarily residing in New South Wales, Australia, were recruited. Participants completed a baseline questionnaire and a short dietary questionnaire (SDQ-AMD). The intervention included an evidence-based nutrition resource and four monthly calls with a dietitian. Immediately post-intervention, intervention participants repeated the SDQ-AMD and completed a feedback form. At 3 months post-intervention, both study arms repeated the SDQ-AMD. Statistical analyses included t-tests and McNemar’s test. Intervention participants reported satisfaction with the tailored phone calls, nutrition resource and nutrition education provided. At 3 months post-intervention, there was no statistically significant difference between study arms in the proportion of participants meeting the dietary goals nor in intake (mean servings ± SE) of total vegetables (primary outcome) and other key food groups; however, there was a significantly higher intake of nuts (secondary outcome) (3.96 ± 0.51 vs. 2.71 ± 0.32; p = 0.04) among participants in the intervention versus control group. Within the intervention arm, there were also significant improvements in intakes of the following secondary outcomes: dark green leafy vegetables (0.99 ± 0.17 vs. 1.71 ± 0.22; p = 0.003) and legumes (0.69 ± 0.10 vs. 1.12 ± 0.16; p = 0.02) and intake of sweets and processed/prepared foods (8.31 ± 0.76 vs. 6.54 ± 0.58, p = 0.01). In summary, although there were few dietary differences between study arms at 3 months post-intervention, the intervention involving four monthly calls was acceptable and helpful to the participants. This type of intervention therefore has the potential to provide people with AMD the needed support for improving their nutrition knowledge and dietary practices, especially if continued over a longer period.

scholarly journals Acupuncture for the Treatment of Oculomotor Paralysis: A Pilot Randomised Controlled Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-6 ◽  
Author(s):  
Jia-Qi Bi ◽  
Wei Li ◽  
Qi Yang ◽  
Bao-lin Li ◽  
Qing-Gang Meng ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Adverse Events ◽  
Response Rate ◽  
Controlled Trial ◽  
Sham Acupuncture ◽  
Acupuncture Group ◽  
Secondary Outcome ◽  
Palpebral Fissure ◽  
Significant Difference ◽  
Randomised Controlled

This study consisted of a single centre randomised controlled trial with two parallel arms: an acupuncture group (n=20) with 27 affected eyes and a sham group (n=20) with 23 affected eyes. Participants in the acupuncture group received acupuncture treatment once daily, three times weekly for four weeks. Participants assigned to the control group received sham acupuncture, the same protocol as that used for the acupuncture group but without insertion of needles into the skin. The primary outcome measure was the cervical range of motion (CROM) score. Secondary outcome measures were the palpebral fissure size, response rate, and adverse events. All 40 participants completed the study. In the comparison of acupuncture and sham acupuncture, a significant difference was observed between acupuncture and sham acupuncture in CROM score (21.37±15.16and32.21±19.54, resp.) (P<0.05) and palpebral fissure size (7.19±2.94and5.41±2.45, resp.) (P<0.05). Response rate was also significantly different in the acupuncture group (P<0.05). No adverse events were reported in both groups in this study. In summary, it was demonstrated that acupuncture had a feasibility positive effect on oculomotor paralysis.

scholarly journals Quarterly versus annual ECG screening for atrial fibrillation in older Chinese (AF-CATCH): a prospective, randomised, controlled trial

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
W Zhang ◽  
Y Chen ◽  
J.G Wang ◽  
Keyword(s):  
Atrial Fibrillation ◽  
Randomised Controlled Trial ◽  
Detection Rate ◽  
Controlled Trial ◽  
Hazard Ratio ◽  
Private Company ◽  
Significant Difference ◽  
Randomised Controlled ◽  
Incident Cases

Abstract Background Screening for atrial fibrillation before symptoms manifested and subsequent initiation of oral anticoagulants (OACs), could prevent stroke and death. The most cost-effective strategy to screen atrial fibrillation in high-risk population aged 65 and over remains unknown. Methods We performed a randomised controlled trial that compares different screening frequencies of 30-second single-lead electrocardiography (ECG) in the detection of atrial fibrillation in Chinese residents (≥65 years old) in 5 community health centres in Shanghai. Participants without atrial fibrillation were randomised in a 1:1 ratio into annual (G1) and quarterly screening (G2) groups: the quarterly screening group was further randomised in a 3:1 ratio into subgroups of quarterly screening (G2–1) and quarterly screening PLUS (G2–2, ECG weekly for 1-month then quarterly). The primary outcome was the detection rate of atrial fibrillation. The intention-to-treat analysis was performed for all randomised patients who had at least one ECG recording during follow-up. Results Between April 17, 2017, and June 26, 2018, a total of 8240 participants were randomised into G1 (n=4120), G2–1 (n=3090) and G2–2 (n=1030), with a mean of 1.6, 3.5 and 5.2 ECG records respectively during a median of 2.1 years follow-up (13,284 person-years). 73 incident cases of atrial fibrillation occurred: 26 in G1 (4.1/1000 person-years) and 47 in G2 (6.7/1000 person-years; hazard ratio with G1, 1.71; 95% confidence interval [CI] 1.06–2.76; P=0.03). 40 incident cases were detected in G2–1 (7.2/1000 person-years; hazard ratio with G1, 1.83; 95% CI 1.12–3.00; P=0.02) and 7 in G2–2 (4.8/1000 person-years; hazard ratio with G1, 1.24; 95% CI 0.54–2.86; P=0.61). No significant difference was noted between G2–1 and G2–2 (hazard ratio with G2–1, 0.68; 95% CI 0.30–1.52; P=0.35). Conclusion Quarterly 30-second single-lead ECG screening significantly increased the detection rate of incident atrial fibrillation. FUNDunding Acknowledgement Type of funding sources: Private company. Main funding source(s): Bayer Healthcare Company

scholarly journals Amiloride does not protect retinal nerve fibre layer thickness in optic neuritis in a phase 2 randomised controlled trial

2017 ◽  
Vol 25 (2) ◽  
pp. 246-255 ◽  
Author(s):  
Justin B McKee ◽  
Charles L Cottriall ◽  
John Elston ◽  
Simon Epps ◽  
Nikos Evangelou ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Optic Neuritis ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
First Episode ◽  
Phase 2 ◽  
Acute Optic Neuritis ◽  
Significant Difference ◽  
Randomised Controlled

Background: Recent basic and clinical evidence suggests amiloride may be neuroprotective in multiple sclerosis (MS) through the blockade of the acid sensing ion channel (ASIC). Objective: To examine the neuroprotective efficacy of amiloride in acute optic neuritis (ON). Methods: A total of 48 patients were recruited to a phase 2, double blind, single site, randomised controlled trial. Scanning laser polarimetry (GDx) at 6 months was the primary outcome measure and optical coherence tomography (OCT) and visual and electrophysiological measures were secondary outcome measures. Participants aged 18–55 years, ≤28 days of onset of first episode unilateral ON, were randomised to amiloride (10 mg daily for 5 months) or placebo ( clinicaltrials.gov , NCT 01802489). Results: Intention-to-treat (ITT) cohort consisted of 43 patients; 23 placebo and 20 amiloride. No significant drug-related adverse events occurred. No significant differences were found in GDx ( p = 0.840). Visual evoked potentials (VEP) were significantly prolonged in the amiloride group compared to placebo ( p = 0.004). All other secondary outcome measures showed no significant difference. Baseline analysis of OCT data demonstrated a significant pre-randomisation thinning of ganglion cell layer. Conclusion: Amiloride has not demonstrated any neuroprotective benefit within this trial paradigm, but future neuroprotective trials in ON should target the window of opportunity to maximise potential neuroprotective benefit.

Efficacy and Safety of Auriculopressure for Primary Care Patients with Chronic Non-Specific Spinal Pain: A Multicentre Randomised Controlled Trial

2014 ◽  
Vol 32 (3) ◽  
pp. 227-235 ◽  
Author(s):  
Jorge Vas ◽  
Manuela Modesto ◽  
Inmaculada Aguilar ◽  
Camila da Silva Gonçalo ◽  
Francisco Rivas-Ruiz
Keyword(s):  
Randomised Controlled Trial ◽  
Primary Healthcare ◽  
Controlled Trial ◽  
Spinal Pain ◽  
Secondary Outcome ◽  
Visual Analogue Scale Pain ◽  
Efficacy And Safety ◽  
Significant Difference ◽  
Quality Of Life Scale ◽  
Randomised Controlled

Background Chronic uncomplicated musculoskeletal pain in the spine (cervical, thoracic or lumbar) is highly prevalent and may severely limit the daily activities of those affected by it. Objective To evaluate the efficacy and safety of treatment with auriculopressure applied to patients with non-specific spinal pain. Methods A multicentre randomised controlled trial with two parallel arms (true auriculopressure (TAP) and placebo auriculopressure (PAP)) was performed. The intervention phase lasted 8 weeks and outcomes were measured 1 week after the last intervention (T1) and 6 months after baseline (T2). The primary outcome measure was change in pain intensity according to a 100 mm visual analogue scale (pain VAS) at T1. Secondary outcome measures were the Lattinen index, the McGill Pain Questionnaire and the SF-12 health-related quality of life scale (Spanish version in every case). Results There were 265 participants (TAP group, n=130; PAP group, n=135). Pain was most frequently located in the upper back (55.1%, n=146), followed by the lower back (25.3%, n=67) and the dorsal area (12.5%, n=33). Nineteen patients (7.2%) reported pain affecting the entire spine. There were statistically significant differences between TAP and PAP in the change in the pain VAS at T1 of 10 mm (95% CI 2.8 to 17.3, p=0.007) and in the change in the pain VAS at T2 of 7.2 mm (95% CI 0.02 to 14.3, p=0.049) in favour of TAP. We also observed a statistically significant difference of 3.4 points in the physical component of the SF-12 in favour of TAP at T2 (95% CI 0.45 to 6.3, p=0.024). No severe adverse effects were detected or reported during treatment. Conclusions The application of auriculopressure in patients with non-specific spinal pain in primary healthcare is effective and safe, and therefore should be considered for inclusion in the portfolio of primary healthcare services. Trial Registration Number ISRCTN01897462.

scholarly journals PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050582
Author(s):  
Annette Mollerup ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Marius Henriksen ◽  
Mette Kildevaeld Simonsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hospital Admission ◽  
Usual Care ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Self Care ◽  
Secondary Outcome ◽  
Link Type ◽  
Randomised Controlled ◽  
At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

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