scholarly journals Performance and evaluation in computed tomographic colonography screening: protocol for a cluster randomised trial

2020 ◽  
Author(s):  
Andrew A Plumb ◽  
Anu E Obaro ◽  
Paul Bassett ◽  
Rachel Baldwin-Cleland ◽  
Steve Halligan ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Patient Outcome ◽  
Randomised Trial ◽  
Research Network ◽  
Cluster Randomised Trial ◽  
Computed Tomographic Colonography ◽  
Computed Tomographic ◽  
Link Type ◽  
Cluster Randomised ◽  
The Impact

ABSTRACTBackgroundColorectal cancer (CRC) is a common, important healthcare priority and improving patient outcome relies on early diagnosis. Colonoscopy and computed tomographic colonography (CTC) are commonly-used diagnostic tests. Although colonoscopists are highly regulated and must be accredited, no analogous process exists for CTC. There are currently no universally accepted radiologist performance indicators for CTC, and lack of regulatory oversight may lead to variability in quality and lower neoplasia detection rates. This study aims to determine whether a structured educational training and feedback programme can improve radiologist interpretation accuracy.MethodsNHS England CTC reporting radiologists will be cluster randomised to either an intervention (one-day individualised training and assessment with feedback) or control (assessment with no training or feedback) arm. Each cluster represents radiologists reporting CTC in a single NHS site. Both the intervention and control arm will undertake four CTC assessments at baseline, 1-month (after training; intervention arm or enrolment; control arm), 6- and 12 months to assess their detection of colorectal cancer (CRC) and 6mm+ polyps. The primary outcome will be difference in sensitivity at the 1-month test between arms. Secondary outcomes will include sensitivity at 6 and 12 months and radiologist characteristics associated with improved performance. Multilevel logistic regression will be used to analyse per-polyp and per-case sensitivity. Local ethical and Health Research Authority approval have been obtained.DiscussionLack of infrastructure to ensure that CTC radiologists can report adequately and lack of consensus regarding appropriate quality metrics may lead to variability in performance. Our provision of a structured education programme with feedback will evaluate the impact of individualised training and identify the factors related to improved radiologist performance in CTC reporting. An improvement in performance could lead to increased neoplasia detection and better patient outcome.RegistrationClinical Trials (ClinicalTrials.gov Identifier: NCT02892721); available from: https://clinicaltrials.gov/ct2/show/NCT02892721. NIHR Clinical Research Network (CPMS ID 32293).

scholarly journals The RATIONS (Reducing Activation of Tuberculosis by Improvement of Nutritional Status) study: a cluster randomised trial of nutritional support (food rations) to reduce TB incidence in household contacts of patients with microbiologically confirmed pulmonary tuberculosis in communities with a high prevalence of undernutrition, Jharkhand, India

BMJ Open ◽  
2021 ◽  
Vol 11 (5) ◽  
pp. e047210
Author(s):  
Anurag Bhargava ◽  
Madhavi Bhargava ◽  
Banurekha Velayutham ◽  
Kannan Thiruvengadam ◽  
Basilea Watson ◽  
...  
Keyword(s):  
Risk Factor ◽  
Nutritional Status ◽  
G Proteins ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Household Contacts ◽  
Cluster Randomised ◽  
High Prevalence ◽  
Secondary Outcomes ◽  
The Impact

IntroductionIndia has the largest burden of cases and deaths related to tuberculosis (TB). Undernutrition is the leading risk factor accounting for TB incidence, while severe undernutrition is a common risk factor for mortality in patients with TB in India. The impact of nutritional supplementation on TB incidence is unknown, while few underpowered studies have assessed its impact on TB mortality. We designed an open-label, field-based cluster randomised trial to assess the impact of nutritional supplementation (with food rations) on TB incidence in a group at higher risk of TB infection and disease, viz household contacts (HHC) of patients with microbiologically confirmed pulmonary TB (PTB) in Jharkhand, a state with a high prevalence of undernutrition.Methods and analysisWe shall enrol 2800 adult patients with PTB of the national TB programme, across 28 treatment units in 4 districts, and their approximately 11 200 eligible contacts. The sample size has 80% power to detect the primary outcome of 50% reduction in incidence of active TB in HHC over 2 years of follow-up. Patients and HHC in both the arms will undergo nutritional assessment and counselling. Patients will receive monthly food rations (supplying 1200 kcal and 52 g proteins/day) and multivitamins along with antitubercular treatment. The HHC in the intervention arm will receive food rations (supplying 750 kcal and 23 g proteins/day) and multivitamins while HHC in control arm will be on usual diet. The secondary outcomes in HHC will include effects on nutritional status, non-TB infections. Secondary outcomes in patients are effects on TB mortality, adherence, adverse effects, nutritional and performance status. Substudies will examine micronutrient status and effects on dietary intake, body composition, muscle strength and immune function.Ethics and disseminationThe institutional ethics committee of ICMR-NIRT, Chennai, approved the study (289/NIRT-IEC/2018). The results will be disseminated in publications and presentations.Trial registration numberClinical Trial Registry of India: CTRI/2019/08/020490.

Cluster randomised trial of the impact of biosecurity measures on poultry health in backyard flocks

2013 ◽  
Vol 198 (3) ◽  
pp. 649-655 ◽  
Author(s):  
Anne Conan ◽  
Flavie Luce Goutard ◽  
Davun Holl ◽  
Sok Ra ◽  
Aurélia Ponsich ◽  
...  
Keyword(s):  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Backyard Flocks ◽  
The Impact

Computed tomographic colonography versus barium enema for diagnosis of colorectal cancer or large polyps in symptomatic patients (SIGGAR): a multicentre randomised trial

The Lancet ◽  
2013 ◽  
Vol 381 (9873) ◽  
pp. 1185-1193 ◽  
Author(s):  
Steve Halligan ◽  
Kate Wooldrage ◽  
Edward Dadswell ◽  
Ines Kralj-Hans ◽  
Christian von Wagner ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Barium Enema ◽  
Randomised Trial ◽  
Computed Tomographic Colonography ◽  
Computed Tomographic

scholarly journals Implementation and evaluation of short peripheral intravenous catheter flushing guidelines: a stepped wedge cluster randomised trial

BMC Medicine ◽  
2020 ◽  
Vol 18 (1) ◽  
Author(s):  
Samantha Keogh ◽  
Caroline Shelverton ◽  
Julie Flynn ◽  
Gabor Mihala ◽  
Saira Mathew ◽  
...  
Keyword(s):  
Patient Outcomes ◽  
Control Period ◽  
Randomised Trial ◽  
Intervention Group ◽  
Trial Registration ◽  
Cluster Randomised Trial ◽  
Stepped Wedge ◽  
Intention To Treat ◽  
Cluster Randomised ◽  
The Impact

Abstract Background Peripheral intravenous catheters (PIVCs) are ubiquitous medical devices, crucial to providing essential fluids and drugs. However, post-insertion PIVC failure occurs frequently, likely due to inconsistent maintenance practice such as flushing. The aim of this implementation study was to evaluate the impact a multifaceted intervention centred on short PIVC maintenance had on patient outcomes. Methods This single-centre, incomplete, stepped wedge, cluster randomised trial with an implementation period was undertaken at a quaternary hospital in Queensland, Australia. Eligible patients were from general medical and surgical wards, aged ≥ 18 years, and requiring a PIVC for > 24 h. Wards were the unit of randomisation and allocation was concealed until the time of crossover to the implementation phase. Patients, clinicians, and researchers were not masked but infections were adjudicated by a physician masked to allocation. Practice during the control period was standard care (variable practice with manually prepared flushes of 0.9% sodium chloride). The intervention group received education reinforcing practice guidelines (including administration with manufacturer-prepared pre-filled flush syringes). The primary outcome was all-cause PIVC failure (as a composite of occlusion, infiltration, dislodgement, phlebitis, and primary bloodstream or local infection). Analysis was by intention-to-treat. Results Between July 2016 and February 2017, 619 patients from 9 clusters (wards) were enrolled (control n = 306, intervention n = 313), with 617 patients comprising the intention-to-treat population. PIVC failure was 91 (30%) in the control and 69 (22%) in the intervention group (risk difference − 8%, 95% CI − 14 to − 1, p = 0.032). Total costs were lower in the intervention group. No serious adverse events related to study intervention occurred. Conclusions This study demonstrated the effectiveness of post-insertion PIVC flushing according to recommended guidelines. Evidence-based education, surveillance and products for post-insertion PIVC management are vital to improve patient outcomes. Trial registration Trial submitted for registration on 25 January 2016. Approved and retrospectively registered on 4 August 2016. Ref: ACTRN12616001035415.

scholarly journals Effectiveness of conditional cash transfers (Afya credits incentive) to retain women in the continuum of care during pregnancy, birth and the postnatal period in Kenya: a cluster-randomised trial

BMJ Open ◽  
2022 ◽  
Vol 12 (1) ◽  
pp. e055921
Author(s):  
Fedra Vanhuyse ◽  
Oliver Stirrup ◽  
Aloyce Odhiambo ◽  
Tom Palmer ◽  
Sarah Dickin ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Randomised Trial ◽  
Electronic System ◽  
Continuum Of Care ◽  
Cash Transfers ◽  
Conditional Cash Transfers ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
The Impact ◽  
The Continuum

ObjectivesGiven high maternal and child mortality rates, we assessed the impact of conditional cash transfers (CCTs) to retain women in the continuum of care (antenatal care (ANC), delivery at facility, postnatal care (PNC) and child immunisation).DesignWe conducted an unblinded 1:1 cluster-randomised controlled trial.Setting48 health facilities in Siaya County, Kenya were randomised. The trial ran from May 2017 to December 2019.Participants2922 women were recruited to the control and 2522 to the intervention arm.InterventionsAn electronic system recorded attendance and triggered payments to the participant’s mobile for the intervention arm (US$4.5), and phone credit for the control arm (US$0.5). Eligibility criteria were resident in the catchment area and access to a mobile phone.Primary outcomesPrimary outcomes were any ANC, delivery, any PNC between 4 and 12 months after delivery, childhood immunisation and referral attendance to other facilities for ANC or PNC. Given problems with the electronic system, primary outcomes were obtained from maternal clinic books if participants brought them to data extraction meetings (1257 (50%) of intervention and 1053 (36%) control arm participants). Attendance at referrals to other facilities is not reported because of limited data.ResultsWe found a significantly higher proportion of appointments attended for ANC (67% vs 60%, adjusted OR (aOR) 1.90; 95% CI 1.36 to 2.66) and child immunisation (88% vs 85%; aOR 1.74; 95% CI 1.10 to 2.77) in intervention than control arm. No intervention effect was seen considering delivery at the facility (90% vs 92%; aOR 0.58; 95% CI 0.25 to 1.33) and any PNC attendance (82% vs 81%; aOR 1.25; 95% CI 0.74 to 2.10) separately. The pooled OR across all attendance types was 1.64 (1.28 to 2.10).ConclusionsDemand-side financing incentives, such as CCTs, can improve attendance for appointments. However, attention needs to be paid to the technology, the barriers that remain for delivery at facility and PNC visits and encouraging women to attend ANC visits within the recommended WHO timeframe.Trial registrationNCT03021070.

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