scholarly journals Effectiveness of intermittent screening and treatment for the control of malaria in pregnancy: a cluster randomised trial in India

2019 ◽  
Vol 4 (4) ◽  
pp. e001399 ◽  
Author(s):  
Irene Kuepfer ◽  
Neelima Mishra ◽  
Jane Bruce ◽  
Vinit Mishra ◽  
Anupkumar R Anvikar ◽  
...  
Keyword(s):  
Gestational Age ◽  
Controlled Trial ◽  
Placental Malaria ◽  
Randomised Trial ◽  
Cluster Randomised Controlled Trial ◽  
Malaria In Pregnancy ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Secondary Endpoints ◽  
In Pregnancy

BackgroundThe control of malaria in pregnancy (MiP) in India relies on testing women who present with symptoms or signs suggestive of malaria. We hypothesised that intermittent screening and treatment for malaria at each antenatal care visit (ISTp) would improve on this approach and reduce the adverse effects of MiP.MethodsA cluster randomised controlled trial comparing ISTp versus passive case detection (PCD) was conducted in Jharkhand state. Pregnant women of all parities with a gestational age of 18–28 weeks were enrolled. Women in the ISTp group were screened with a rapid diagnostic test (RDT) for malaria at each antenatal clinic visit and those in the PCD group were screened only if they had symptoms or signs suggestive of malaria. All RDT positive women were treated with artesunate/sulfadoxine–pyrimethamine. The primary endpoint was placental malaria, determined by placental histology, and the key secondary endpoints were birth weight, gestational age, vital status of the newborn baby and maternal anaemia.ResultsBetween April 2012 and September 2015, 6868 women were enrolled; 3300 in 46 ISTp clusters and 3568 in 41 PCD clusters. In the ISTp arm, 4.9% of women were tested malaria positive and 0.6% in the PCD arm. There was no difference in the prevalence of placental malaria in the ISTp (87/1454, 6.0%) and PCD (65/1560, 4.2%) groups (6.0% vs 4.2%; OR 1.34, 95% CI 0.78 to 2.29, p=0.29) or in any of the secondary endpoints.ConclusionISTp detected more infections than PCD, but monthly ISTp with the current generation of RDT is unlikely to reduce placental malaria or impact on pregnancy outcomes. ISTp trials with more sensitive point-of-care diagnostic tests are needed.

scholarly journals Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e023436 ◽  
Author(s):  
Christian Gold ◽  
Jasmin Eickholt ◽  
Jörg Assmus ◽  
Brynjulf Stige ◽  
Jo Dugstad Wake ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Rating Scale ◽  
Controlled Trial ◽  
Elderly Care ◽  
Neuropsychiatric Symptoms ◽  
Care Home ◽  
Randomised Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised Trial ◽  
Cluster Randomised

IntroductionIn older adults, dementia and depression are associated with individual distress and high societal costs. Music interventions such as group music therapy (GMT) and recreational choir singing (RCS) have shown promising effects, but their comparative effectiveness across clinical subgroups is unknown. This trial aims to determine effectiveness of GMT, RCS and their combination for care home residents and to examine heterogeneity of treatment effects across subgroups.Methods and analysisThis large, pragmatic, multinational cluster-randomised controlled trial with a 2×2 factorial design will compare the effects of GMT, RCS, both or neither, for care home residents aged 65 years or older with dementia and depressive symptoms. We will randomise 100 care home units with ≥1000 residents in total across eight countries. Each intervention will be offered for 6 months (3 months 2 times/week followed by 3 months 1 time/week), with extension allowed if locally available. The primary outcome will be the change in the Montgomery-Åsberg Depression Rating Scale score at 6 months. Secondary outcomes will include depressive symptoms, cognitive functioning, neuropsychiatric symptoms, psychotropic drug use, caregiver burden, quality of life, mortality and costs over at least 12 months. The study has 90% power to detect main effects and is also powered to determine interaction effects with gender, severity and socioeconomic status.Ethics and disseminationEthical approval has been obtained for one country and will be obtained for all countries. Results will be presented at national and international conferences and published in scientific journals.Trial registration numbersNCT03496675; Pre-results, ACTRN12618000156280.

scholarly journals Enhanced hypertension care through private clinics in Pakistan: a cluster randomised trial

BJGP Open ◽  
2019 ◽  
Vol 3 (1) ◽  
pp. bjgpopen18X101617 ◽  
Author(s):  
Muhammad Amir Khan ◽  
Nida Khan ◽  
John D Walley ◽  
Shaheer Ellahi Khan ◽  
Joseph Hicks ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Urban Areas ◽  
Controlled Trial ◽  
Clinical Care ◽  
Randomised Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised Trial ◽  
Cvd Risk ◽  
Cluster Randomised

BackgroundHypertension in Pakistan affects 33% of people aged ≥45 years, and in urban areas around 70% of basic health care occurs in private facilities.AimTo assess whether enhanced care at urban private clinics resulted in better control of hypertension, cardiovascular disease (CVD) risk factors, and treatment adherence.Design & settingA two-arm cluster randomised controlled trial was conducted at 26 private clinics (in three districts of Punjab) between January 2015–September 2016. Both arms had enhanced screening and diagnosis of hypertension and related conditions, and patient recording processes. Intervention facilities also had a clinical care guide, additional drugs for hypertension, a patient lifestyle education flipchart, associated training, and mobile phone follow-up.MethodClinics were randomised in a 1:1 ratio (sealed envelope lottery method). A total of 574 intervention and 564 control patients in 13 clusters in each arm were recruited (male and female, aged ≥25 years, systolic blood pressure [SBP] >140 mmHg, and/or diastolic blood pressure [DBP] >90 mmHg). The primary outcome was change in SBP from baseline to 9-month follow-up.Staff and patients were not blinded, but outcome assessors were blinded.ResultsNine-month primary outcomes were available for 522/574 (90.9%) intervention and 484/564 (85.8%) control participants (all clusters). The unadjusted cluster-level analysis results were as follows: mean intervention outcome was -25.2 mmHg (95% confidence intervals [CI] = -29.9 to-20.6); mean control outcome was -9.4 mmHg (95% CI = 21.2 to 2.2); and mean control–intervention difference was 15.8 (95% CI = 3.6 to 28.0; P = 0.01).ConclusionThe findings and separate process evaluation support the scaling of an integrated CVD–hypertension care intervention in urban private clinics in areas lacking public primary care in Pakistan.

scholarly journals Does soccer headgear reduce the incidence of sport-related concussion? A cluster, randomised controlled trial of adolescent athletes

2019 ◽  
Vol 54 (7) ◽  
pp. 408-413 ◽  
Author(s):  
Timothy McGuine ◽  
Eric Post ◽  
Adam Yakuro Pfaller ◽  
Scott Hetzel ◽  
Allison Schwarz ◽  
...  
Keyword(s):  
High School ◽  
Proportional Hazards ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cox Proportional Hazards ◽  
Soccer Players ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Randomised Controlled

BackgroundThere have been no large randomised controlled trials to determine whether soccer headgear reduces the incidence or severity of sport-related concussion (SRC) in US high school athletes.ObjectiveWe aimed to determine whether headgear reduces the incidence or severity (days out from soccer) of SRCs in soccer players.Methods2766 participants (67% female, age 15.6±1.2) (who undertook 3050 participant years) participated in this cluster randomised trial. Athletes in the headgear (HG) group wore headgear during the season, while those in the no headgear (NoHG) group did not. Staff recorded SRC and non-SRC injuries and soccer exposures. Multivariate Cox proportional hazards models were used to examine time-to-SRC between groups, while severity was compared with a Wilcoxon rank-sum test.Results130 participants (5.3% female, 2.2% male) sustained an SRC. The incidence of SRC was not different between the HG and NoHG groups for males (HR: 2.00 (0.63–6.43) p=0.242) and females (HR: 0.86 (0.54–1.36) p=0.520). Days lost from SRC were not different (p=0.583) between the HG group (13.5 (11.0–018.8) days) and the NoHG group (13.0 (9.0–18.8) days).ConclusionsSoccer headgear did not reduce the incidence or severity of SRC in high school soccer players.Trial registration numberNCT02850926.

scholarly journals A cluster randomised trial of a Needs Assessment Tool for adult Cancer patients and their carers (NAT-C) in primary care: A feasibility study

PLoS ONE ◽  
2021 ◽  
Vol 16 (1) ◽  
pp. e0245647
Author(s):  
Joseph Clark ◽  
Elvis Amoakwa ◽  
Alexandra Wright-Hughes ◽  
John Blenkinsopp ◽  
David C. Currow ◽  
...  
Keyword(s):  
Needs Assessment ◽  
Assessment Tool ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Unmet Need ◽  
Cluster Randomised Controlled Trial ◽  
Recruitment Rate ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Randomised Controlled

Background People with cancer often have unidentified symptoms and social care needs. The Needs Assessment Tool-Cancer (NAT-C) is a validated, structured method of assessing patient/carer concerns and prompting action, to address unmet need. Aims Assess feasibility and acceptability of a definitive two-armed cluster randomised trial of NAT-C in primary care by evaluating: recruitment of GP practices, patients and carers; most effective approach of ensuring NAT-C appointments, acceptability of study measures and follow-up. Methods Non-blinded, feasibility study in four General Practices, with cluster randomisation to method of NAT-C appointment delivery, and process evaluation. Adults with active cancer were invited to participate with or without carer. Practices cluster randomised (1:1) to Arm I: promotion and use of NAT-C with a NAT-C trained clinician or Arm II: clinician of choice irrespective of training status. Participants completed study questionnaires at: baseline, 1, 3 and 6 months. Patients booked a 20 minute needs-assessment appointment post-baseline. Patients, carers and GP practice staff views regarding the study sought through interviews/focus groups. Quantitative data were analysed descriptively. Qualitative data were analysed thematically, informed by Normalisation Process Theory. Progression to a definitive trial was assessed against feasibility outcomes, relating to: recruitment rate, uptake and delivery of the NAT-C, data collection and quality. Results Five GP practices approached, four recruited and trained to use the NAT-C. Forty-seven participants and 17 carers recruited. At baseline, 34/47 (72%) participants reported at least one moderate-severe unmet need, confirming study rationale. 32/47 (68%) participants received a NAT-C-guided consultation, 19 of which on Arm I. Study attrition at one month (n = 44 (94%), n = 16 (94%)), three months (n = 38 (81%), n = 14 (82%)) and six months (n = 32 (68%), n = 10 (59%)). Fifteen patient interviews conducted across the whole study and one focus group at each GP practice. Participants supported a definitive study and found measures acceptable. Conclusion The feasibility trial indicated that recruitment rate, intervention uptake and data collection were appropriate, with refinements, for a definitive multi-centre cluster randomised controlled trial. Feasibility outcomes informed the design of a 2-armed cluster randomised controlled trial to test the effectiveness and cost-effectiveness of the NAT-C compared with usual care.

scholarly journals Reducing the Social Gradient in Uptake of the NHS Colorectal Cancer Screening Programme Using a Narrative-Based Information Leaflet: A Cluster-Randomised Trial

2016 ◽  
Vol 2016 ◽  
pp. 1-10 ◽  
Author(s):  
Lesley M. McGregor ◽  
Christian von Wagner ◽  
Wendy Atkin ◽  
Ines Kralj-Hans ◽  
Stephen P. Halloran ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Screening Programme ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Pragmatic Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised Trial ◽  
Crc Screening ◽  
True Value ◽  
Cluster Randomised

Objective. To test the effectiveness of adding a narrative leaflet to the current information material delivered by the NHS English colorectal cancer (CRC) screening programme on reducing socioeconomic inequalities in uptake.Participants. 150,417 adults (59–74 years) routinely invited to complete the guaiac Faecal Occult Blood test (gFOBt) in March 2013.Design. A cluster randomised controlled trial (ISRCTN74121020) to compare uptake between two arms. The control arm received the standard NHS CRC screening information material (SI) and the intervention arm received the standard information plus a supplementary narrative leaflet, which had previously been shown to increase screening intentions (SI + N). Between group comparisons were made for uptake overall and across socioeconomic status (SES).Results. Uptake was 57.7% and did not differ significantly between the two trial arms (SI: 58.5%; SI + N: 56.7%; odds ratio = 0.93; 95% confidence interval: 0.81–1.06;p=0.27). There was no interaction between group and SES quintile (p=0.44).Conclusions. Adding a narrative leaflet to existing information materials does not reduce the SES gradient in uptake. Despite the benefits of using a pragmatic trial design, the need to add to, rather than replace, existing information may have limited the true value of an evidence-based intervention on behaviour.

scholarly journals A Police Partnership Targeting Truancy: Study Protocol for a Cluster Randomised Controlled Trial

2020 ◽  
Vol 4 (3-4) ◽  
pp. 134-159
Author(s):  
Lorraine Mazerolle ◽  
Sarah Bennett ◽  
Stephanie M. Cardwell
Keyword(s):  
School Engagement ◽  
Statistical Power ◽  
School Attendance ◽  
Controlled Trial ◽  
Research Question ◽  
Randomised Trial ◽  
Cluster Randomised Controlled Trial ◽  
Cluster Randomised Trial ◽  
Cluster Randomised ◽  
Randomised Controlled

Abstract Research Question How can an Australian police agency best test its role in a truancy prevention programme that can help to prevent crime? Data Operational and analytic planning for testing the Ability School Engagement Partnership (ASEP) programme in Queensland that aims to increase school attendance and reduce anti-social behaviour, including offending. Methods Fulfilling the requirements for registering a randomised trial protocol with the Clinicaltrials.gov Registry (NCT04281966; date registered 24 February 2020). Findings A protocol deploying a cluster randomised trial offers sufficient statistical power to detect a moderately large effect size as statistically significant with 80% probability. Conclusion Implementation of this protocol as planned would provide an internally valid test of the effectiveness of the ASEP programme in real-world conditions.

scholarly journals Bypassing nearest hospital for more distant neuroscience care in head-injured adults with suspected traumatic brain injury: findings of the head injury transportation straight to neurosurgery (HITS-NS) pilot cluster randomised trial

BMJ Open ◽  
2017 ◽  
Vol 7 (10) ◽  
pp. e016355 ◽  
Author(s):  
Fiona Elizabeth Lecky ◽  
Wanda Russell ◽  
Graham McClelland ◽  
Elspeth Pennington ◽  
Gordon Fuller ◽  
...  
Keyword(s):  
Traumatic Brain Injury ◽  
Brain Injury ◽  
Injury Severity ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Measurable Effect ◽  
Cluster Randomised ◽  
Head Injured ◽  
Secondary Transfer

ObjectiveReconfiguration of trauma services, with direct transport of patients with traumatic brain injury (TBI) to specialist neuroscience centres (SNCs)—bypassing non-specialist acute hospitals (NSAHs), could improve outcomes. However, delays in stabilisation of airway, breathing and circulation (ABC) may worsen outcomes when compared with selective secondary transfer from nearest NSAH to SNC. We conducted a pilot cluster randomised controlled trial to determine the feasibility and plausibility of bypassing suspected patients with TBI —directly into SNCs—producing a measurable effect.SettingTwo English Ambulance Services.Participants74 clusters (ambulance stations) were randomised within pairs after matching for important characteristics. Clusters enrolled head-injured adults—injured nearest to an NSAH—with internationally accepted TBI risk factors and stable ABC. We excluded participants attended by Helicopter Emergency Medical Services or who were injured more than 1 hour by road from nearest SNC.InterventionsIntervention cluster participants were transported directly to an SNC bypassing nearest NSAH; control cluster participants were transported to nearest NSAH with selective secondary transfer to SNC.OutcomesTrial recruitment rate (target n=700 per annum) and percentage with TBI on CT scan (target 80%) were the primary feasibility outcomes. 30-day mortality, 6-month Extended Glasgow Outcome Scale and quality of life were secondary outcomes.Results56 ambulance station clusters recruited 293 patients in 12 months. The trial arms were similar in terms of age, conscious level and injury severity. Less than 25% of recruited patients had TBI on CT (n=70) with 7% (n=20) requiring neurosurgery. Complete case analysis showed similar 30-day mortality in the two trial arms (control=8.8 (2.7–14.0)% vs intervention=9.4(2.3–14.0)%).ConclusionBypassing patients with suspected TBI to SNCs gives an overtriage (false positive) ratio of 13:1 for neurosurgical intervention and 4:1 for TBI. A measurable effect from a full trial of early neuroscience care following bypass is therefore unlikely.Trial registration numberISRCTN68087745.

scholarly journals Broader impacts of an intervention to transform school environments on student behaviour and school functioning: post hoc analyses from the INCLUSIVE cluster randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e031589
Author(s):  
Christopher Bonell ◽  
Matthew Dodd ◽  
Elizabeth Allen ◽  
Leonardo Bevilacqua ◽  
Jennifer McGowan ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Randomised Trial ◽  
Cluster Randomised Trial ◽  
Cigarette Use ◽  
School Environments ◽  
Broader Impacts ◽  
Cluster Randomised ◽  
Disciplinary Procedures ◽  
Aggressive Behaviours ◽  
Post Hoc

BackgroundWe have previously reported benefits for reduced bullying, smoking, alcohol and other drug use and mental health from a trial of ‘Learning Together’, an intervention that aimed to modify school environments and implement restorative practice and a social and emotional skill curriculum.ObjectivesTo conduct post hoc theory-driven analyses of broader impacts.DesignCluster randomised trial.Settings40 state secondary schools in southern England.ParticipantsStudents aged 11/12 years at baseline.OutcomesStudent self-reported measures at 24 and 36 months of: cyberbullying victimisation and perpetration; observations of other students perpetrating aggressive behaviours at school; own perpetration of aggressive behaviours in and outside school; perceived lack of safety at school; participation in school disciplinary procedures; truancy and e-cigarette use.ResultsWe found evidence of multiple impacts on other health (reduced e-cigarette use, cyberbullying perpetration, perpetration of aggressive behaviours) and educational (reduced participation in school disciplinary procedures and truancy) outcomes.ConclusionThese analyses suggested that the intervention was effective in bringing about a broader range of beneficial outcomes, adding to the evidence that the intervention is a promising approach to promote adolescent health via an intervention that is attractive to schools.Trial registration numberISRCTN10751359.

scholarly journals We Can Quit2 (WCQ2): a community-based intervention on smoking cessation for women living in disadvantaged areas of Ireland—study protocol for a pilot cluster randomised controlled trial

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Catherine Hayes ◽  
Aurelia Ciblis ◽  
Catherine Darker ◽  
Nadine Dougall ◽  
Joanne Vance ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Health Service ◽  
Sample Size ◽  
Quantitative Methods ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Pilot Trial ◽  
Cluster Randomised Trial ◽  
Community Based ◽  
Cluster Randomised

Abstract Background Tobacco use is the leading cause of preventable death in Ireland with almost 6000 smokers dying each year from smoking-related diseases. The ‘We Can Quit2’ (WCQ2) study is a pilot pragmatic two-arm, parallel-group, cluster randomised trial that aims to explore the feasibility and acceptability of trial processes including recruitment and to estimate parameters to inform sample size estimates needed for an effectiveness trial. This future trial will assess the effectiveness of a community-based smoking cessation intervention for women living in disadvantaged areas on short- and medium-term cessation rates. Methods/design Four matched pairs of districts (eight clusters) selected by area level of deprivation, geographical proximity, and eligibility for free medical services will be randomised to receive either WCQ (behavioural support + access to Nicotine Replacement Therapy (NRT)) delivered over 12 weeks by trained Community Facilitators (CFs) or to a form of usual care, a one-to-one smoking cessation service delivered by Smoking Cessation Officers from Ireland’s national health service, the Health Service Executive (HSE). Within each cluster, 24–25 women will be recruited (97 per arm; 194 in total) in 4 phases with consent obtained prior to cluster randomisation. The outcome measures will assess feasibility and acceptability of trial processes, including randomisation. Outcome data for a future definitive intervention (biochemically validated smoking abstinence) will be collected at end of programme (12 weeks) and at 6 months. WCQ2 has an embedded process evaluation using both qualitative and quantitative methods. This will be conducted (semi-structured client and CF interviews, intervention delivery checklist, and diary) to explore acceptability of trial processes, intervention fidelity, trial context, and implementation. Trial processes will be assessed against domains of the PRECIS-2 wheel to inform a future definitive trial design. Discussion Data from this pilot trial will inform the design and sample size for a full cluster randomised trial to determine the effectiveness of an intervention tailored to disadvantaged women in improving smoking cessation rates. It will provide transferable learning on the systems and implementation strategies needed to support effective design of future pragmatic community-based trials which address health promotion interventions for women in disadvantaged communities. Trial registration Concurrent to publication. Controlled trials ISRCTN74721694.

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