scholarly journals A cluster randomised trial of strategies to increase cervical screening uptake at first invitation (STRATEGIC)

2016 ◽  
Vol 20 (68) ◽  
pp. 1-138 ◽  
Author(s):  
Henry C Kitchener ◽  
Matthew Gittins ◽  
Oliver Rivero-Arias ◽  
Apostolos Tsiachristas ◽  
Margaret Cruickshank ◽  
...  
Keyword(s):  
Discrete Choice ◽  
Choice Experiment ◽  
Phase 1 ◽  
Cervical Screening ◽  
Randomised Trial ◽  
Cost Effective ◽  
Health Technology ◽  
Cluster Randomised Trial ◽  
Phase 2 ◽  
Cluster Randomised

BackgroundFalling participation by young women in cervical screening has been observed at a time that has seen an increase in the incidence of cervical cancer in the UK in women aged < 35 years. Various barriers to screening have been documented, including fear, embarrassment and inconvenience.ObjectivesTo measure the feasibility, clinical effectiveness and cost-effectiveness of a range of interventions to increase the uptake of cervical screening among young women.DesignA cluster randomised trial based on general practices performed in two phases.SettingPrimary care in Greater Manchester and the Grampian region in Scotland.ParticipantsPhase 1: 20,879 women receiving their first invitation for cervical screening. Phase 2: 10,126 women who had not attended by 6 months.InterventionsPhase 1: pre-invitation leaflet or not, and access to online booking (Manchester only). Phase 2: (1) vaginal self-sampling kits (SSKs) sent unrequested (n = 1141); or (2) offered on request (n = 1290); (3) provided with a timed appointment (n = 1629); (4) offered access to a nurse navigator (NN) (n = 1007); or (5) offered a choice between a NN or a SSK (n = 1277); and 3782 women in control practices.Main outcome measuresUplift in screening compared with control practices, cost-effectiveness of interventions, and the women’s preferences explored in a discrete choice experiment.ResultsThe pre-invitation leaflet and offer of online booking were ineffective when compared with control practices at 3 months, 18.8% versus 19.2% [odds ratio (OR) 0.96, 95% confidence interval (CI) 0.88 to 1.06;p = 0.485] and 17.8% versus 17.2% (OR 1.02, 95% CI 0.87 to 1.20;p = 0.802), respectively. The uptake of screening at 3 months was higher among previously human papillomavirus (HPV)-vaccinated women than unvaccinated women, 23.7% versus 11% (OR 2.07, 95% CI 1.69 to 2.53;p < 0.001). Among non-attenders, the SSK sent intervention showed a statistically significant increase in uptake at 12 months post invitation, 21.3% versus 16.2% (OR 1.51, 95% CI 1.20 to 1.91;p = 0.001), as did timed appointments, 19.8% versus 16.2% (OR 1.41, 95% CI 1.14 to 1.74;p = 0.001). The offer of a NN, a SSK on request, and a choice between timed appointments and NN were ineffective. Overall, there was a gradual rather than prompt response, as demonstrated by uptake among control practices. A discrete choice experiment indicated that women invited who had not yet attended valued the attributes inherent in self-sampling. The health economic analysis showed that both timed appointments and unsolicited SSK sent were likely to be cost-effective at a cost per quality-adjusted life-year (QALY) gained of £7593 and £8434, respectively, if extended across the national 25-year-old cohort throughout the duration of screening. The certainty of these being cost-effective at a ceiling ratio of £20,000 per QALY gained was > 90%.ConclusionWomen receiving their initial screening invitation frequently delay taking up the offer and the net impact of interventions was small. Timed appointments and SSKs sent to non-attenders at 6 months are likely to be a cost-effective means of increasing uptake and should be considered further. HPV vaccination in the catch-up programme was associated with an increased uptake of cervical screening. Future work should focus on optimising self-sampling in terms of age range, timing of offer for non-attenders and use of urine testing instead of vaginal samples.Trial registrationCurrent Controlled Trials ISRCTN52303479.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 20, No. 68. See the NIHR Journals Library website for further project information.

scholarly journals Supportive supervision to improve the quality and outcome of outpatient care among malnourished children: a cluster randomised trial in Arua district, Uganda

2019 ◽  
Vol 4 (4) ◽  
pp. e001339 ◽  
Author(s):  
Marzia Lazzerini ◽  
Humphrey Wanzira ◽  
Peter Lochoro ◽  
Richard Muyinda ◽  
Giulia Segafredo ◽  
...  
Keyword(s):  
Quality Of Care ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Supportive Supervision ◽  
Phase 2 ◽  
Cure Rate ◽  
Number Of Children ◽  
Malnourished Children ◽  
Cluster Randomised

IntroductionSuboptimal quality of paediatric care has been reported in resource-limited settings, but little evidence exists on interventions to improve it in such settings. This study aimed at testing supportive supervision (SS) for improving health status of malnourished children, quality of case management, overall quality of care, and the absolute number of children enrolled in the nutritional services.MethodsThis was a cluster randomised trial conducted in Arua district. Six health centres (HCs) with the highest volume of work were randomised to either SS or no intervention. SS was delivered by to HCs staff (phase 1), and later extended to community health workers (CHWs) (phase 2). The primary outcome was the cure rate, measured at children level. Quality of case management was assessed by six pre-defined indicators. Quality of care was assessed using the national Nutrition Service Delivery Assessment (NSDA) tool. Access to care was estimated with the number of children accessing HC nutritional services.ResultsOverall, 737 children were enrolled. In the intervention arm, the cure rate (83.8% vs 44.9%, risk ratio (RR)=1.91, 95% CI: 1.56–2.34, p=0.001), quality of care as scored by NSDA (RR=1.57, 95% CI: 1.01–2.44, p=0.035) and correctness in complementary treatment (RR=1.52, 95% CI: 1.40–1.67, p=0.001) were significantly higher compared with control. With the extension of SS to CHWs (phase 2), there was a significant 38.6% more children accessing care in the intervention HCs (RR=1.26, 95% CI: 1.11–1.44, p=0.001) compared with control.ConclusionSS significantly improved the cure rate of malnourished children, and the overall quality of care, SS to CHWs significantly increased the crude number of children enrolled in the nutritional services. More studies should confirm these results, and evaluate the cost-effectiveness of SS.

scholarly journals Prehospital randomised assessment of a mechanical compression device in out-of-hospital cardiac arrest (PARAMEDIC): a pragmatic, cluster randomised trial and economic evaluation

2017 ◽  
Vol 21 (11) ◽  
pp. 1-176 ◽  
Author(s):  
Simon Gates ◽  
Ranjit Lall ◽  
Tom Quinn ◽  
Charles D Deakin ◽  
Matthew W Cooke ◽  
...  
Keyword(s):  
Systematic Review ◽  
Health Economic ◽  
Cardiac Arrest ◽  
Chest Compression ◽  
Randomised Trial ◽  
Health Technology ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Mechanical Chest Compression ◽  
Hospital Cardiac Arrest

BackgroundMechanical chest compression devices may help to maintain high-quality cardiopulmonary resuscitation (CPR), but little evidence exists for their effectiveness. We evaluated whether or not the introduction of Lund University Cardiopulmonary Assistance System-2 (LUCAS-2; Jolife AB, Lund, Sweden) mechanical CPR into front-line emergency response vehicles would improve survival from out-of-hospital cardiac arrest (OHCA).ObjectiveEvaluation of the LUCAS-2 device as a routine ambulance service treatment for OHCA.DesignPragmatic, cluster randomised trial including adults with non-traumatic OHCA. Ambulance dispatch staff and those collecting the primary outcome were blind to treatment allocation. Blinding of the ambulance staff who delivered the interventions and reported initial response to treatment was not possible. We also conducted a health economic evaluation and a systematic review of all trials of out-of-hospital mechanical chest compression.SettingFour UK ambulance services (West Midlands, North East England, Wales and South Central), comprising 91 urban and semiurban ambulance stations. Clusters were ambulance service vehicles, which were randomly assigned (approximately 1 : 2) to the LUCAS-2 device or manual CPR.ParticipantsPatients were included if they were in cardiac arrest in the out-of-hospital environment. Exclusions were patients with cardiac arrest as a result of trauma, with known or clinically apparent pregnancy, or aged < 18 years.InterventionsPatients received LUCAS-2 mechanical chest compression or manual chest compressions according to the first trial vehicle to arrive on scene.Main outcome measuresSurvival at 30 days following cardiac arrest; survival without significant neurological impairment [Cerebral Performance Category (CPC) score of 1 or 2].ResultsWe enrolled 4471 eligible patients (1652 assigned to the LUCAS-2 device and 2819 assigned to control) between 15 April 2010 and 10 June 2013. A total of 985 (60%) patients in the LUCAS-2 group received mechanical chest compression and 11 (< 1%) patients in the control group received LUCAS-2. In the intention-to-treat analysis, 30-day survival was similar in the LUCAS-2 (104/1652, 6.3%) and manual CPR groups [193/2819, 6.8%; adjusted odds ratio (OR) 0.86, 95% confidence interval (CI) 0.64 to 1.15]. Survival with a CPC score of 1 or 2 may have been worse in the LUCAS-2 group (adjusted OR 0.72, 95% CI 0.52 to 0.99). No serious adverse events were noted. The systematic review found no evidence of a survival advantage if mechanical chest compression was used. The health economic analysis showed that LUCAS-2 was dominated by manual chest compression.LimitationsThere was substantial non-compliance in the LUCAS-2 arm. For 272 out of 1652 patients (16.5%), mechanical chest compression was not used for reasons that would not occur in clinical practice. We addressed this issue by using complier average causal effect analyses. We attempted to measure CPR quality during the resuscitation attempts of trial participants, but were unable to do so.ConclusionsThere was no evidence of improvement in 30-day survival with LUCAS-2 compared with manual compressions. Our systematic review of recent randomised trials did not suggest that survival or survival without significant disability may be improved by the use of mechanical chest compression.Future workThe use of mechanical chest compression for in-hospital cardiac arrest, and in specific circumstances (e.g. transport), has not yet been evaluated.TriaI registrationCurrent Controlled Trials ISRCTN08233942.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 11. See the NIHR Journals Library website for further project information.

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.

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