scholarly journals A Cluster-Randomized Trial of Hydroxychloroquine as Prevention of Covid-19 Transmission and Disease

2020 ◽  
Author(s):  
Oriol Mitja ◽  
Maria Ubals ◽  
Marc Corbacho ◽  
Andrea Alemany ◽  
Clara Suner ◽  
...  
Keyword(s):  
Usual Care ◽  
Randomized Trial ◽  
Primary Outcome ◽  
Cluster Randomized Trial ◽  
Secondary Outcome ◽  
Open Label ◽  
Definitive Evidence ◽  
Beneficial Effects ◽  
Significant Difference ◽  
Cluster Randomized

Background Current strategies for preventing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections are limited to non-pharmacological interventions. Hydroxychloroquine (HCQ) has been proposed as a postexposure therapy to prevent Coronavirus disease 2019 (Covid-19) but definitive evidence is lacking. Methods We conducted an open-label, cluster-randomized trial including asymptomatic contacts exposed to a PCR-positive Covid-19 case in Catalonia, Spain. Clusters were randomized to receive no specific therapy (control arm) or HCQ 800mg once, followed by 400mg daily for 6 days (intervention arm). The primary outcome was PCR-confirmed symptomatic Covid-19 within 14 days. The secondary outcome was SARS-CoV-2 infection, either symptomatically compatible or a PCR-positive result regardless of symptoms. Adverse events (AEs) were assessed up to 28 days. Results The analysis included 2,314 healthy contacts of 672 Covid-19 index cases identified between Mar 17 and Apr 28, 2020. A total of 1,198 were randomly allocated to usual care and 1,116 to HCQ therapy. There was no significant difference in the primary outcome of PCR-confirmed, symptomatic Covid-19 disease (6.2% usual care vs. 5.7% HCQ; risk ratio 0.89 [95% confidence interval 0.54-1.46]), nor evidence of beneficial effects on prevention of SARS-CoV-2 transmission (17.8% usual care vs. 18.7% HCQ). The incidence of AEs was higher in the intervention arm than in the control arm (5.9% usual care vs 51.6% HCQ), but no treatment-related serious AEs were reported. Conclusions Postexposure therapy with HCQ did not prevent SARS-CoV-2 disease and infection in healthy individuals exposed to a PCR-positive case. Our findings do not support HCQ as postexposure prophylaxis for Covid-19.

scholarly journals Effectiveness of upgraded maternity waiting homes and local leader training on improving institutional births: a cluster-randomized controlled trial in Jimma, Ethiopia

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Jaameeta Kurji ◽  
Lakew Abebe Gebretsadik ◽  
Muluemebet Abera Wordofa ◽  
Sudhakar Morankar ◽  
Kunuz Haji Bedru ◽  
...  
Keyword(s):  
Usual Care ◽  
Randomized Trial ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Safe Motherhood ◽  
Link Type ◽  
Local Leader ◽  
Maternity Waiting Homes ◽  
Leader Training ◽  
Cluster Randomized

Abstract Background Maternity waiting homes (MWHs), residential spaces for pregnant women close to obstetric care facilities, are being used to tackle physical barriers to access. However, their effectiveness has not been rigorously assessed. The objective of this cluster randomized trial was to evaluate the effectiveness of functional MWHs combined with community mobilization by trained local leaders in improving institutional births in Jimma Zone, Ethiopia. Methods A pragmatic, parallel arm cluster-randomized trial was conducted in three districts. Twenty-four primary health care units (PHCUs) were randomly assigned to either (i) upgraded MWHs combined with local leader training on safe motherhood strategies, (ii) local leader training only, or (iii) usual care. Data were collected using repeat cross-sectional surveys at baseline and 21 months after intervention to assess the effect of intervention on the primary outcome, defined as institutional births, at the individual level. Women who had a pregnancy outcome (livebirth, stillbirth or abortion) 12 months prior to being surveyed were eligible for interview. Random effects logistic regression was used to evaluate the effect of the interventions. Results Data from 24 PHCUs and 7593 women were analysed using intention-to-treat. The proportion of institutional births was comparable at baseline between the three arms. At endline, institutional births were slightly higher in the MWH + training (54% [n = 671/1239]) and training only arms (65% [n = 821/1263]) compared to usual care (51% [n = 646/1271]). MWH use at baseline was 6.7% (n = 256/3784) and 5.8% at endline (n = 219/3809). Both intervention groups exhibited a non-statistically significant higher odds of institutional births compared to usual care (MWH+ & leader training odds ratio [OR] = 1.09, 97.5% confidence interval [CI] 0.67 to 1.75; leader training OR = 1.37, 97.5% CI 0.85 to 2.22). Conclusions Both the combined MWH+ & leader training and the leader training alone intervention led to a small but non-significant increase in institutional births when compared to usual care. Implementation challenges and short intervention duration may have hindered intervention effectiveness. Nevertheless, the observed increases suggest the interventions have potential to improve women’s use of maternal healthcare services. Optimal distances at which MWHs are most beneficial to women need to be investigated. Trial registration The trial was retrospectively registered on the Clinical Trials website (https://clinicaltrials.gov) on 3rd October 2017. The trial identifier is NCT03299491.

scholarly journals Incentive programmes for smoking cessation: cluster randomized trial in workplaces in Thailand

BMJ ◽  
2020 ◽  
pp. m3797 ◽  
Author(s):  
Justin S White ◽  
Christopher Lowenstein ◽  
Nucharee Srivirojana ◽  
Aree Jampaklay ◽  
William H Dow
Keyword(s):  
Usual Care ◽  
Text Messaging ◽  
Controlled Trial ◽  
Cluster Randomized Trial ◽  
Monetary Incentive ◽  
Care Group ◽  
Smoking Abstinence ◽  
Open Label ◽  
Intention To Treat ◽  
Cluster Randomized

Abstract Objective To compare several monetary incentive programmes for promoting smoking abstinence among employees who smoke at workplaces in a middle income country. Design Parallel group, open label, assessor blinded, cluster randomized controlled trial. Setting Large industrial workplaces in metropolitan Bangkok, Thailand. Participants Employees who smoked cigarettes and planned to quit within six months recruited from 101 worksite clusters (84 different companies). Interventions Worksites were digitally cluster randomized by an independent investigator to usual care or usual care plus one of eight types of incentive programmes. Usual care consisted of one time group counseling and cessation support through a 28 day text messaging programme. The incentive programmes depended on abstinence at three months and varied on three intervention components: refundable deposits, assignment to a teammate, and bonus size ($20 (£15; €17) or $40). Main outcome measures The primary outcome was biochemically verified seven day point prevalence smoking abstinence at 12 months. Secondary outcomes were programme acceptance at enrollment and smoking abstinence at three months (end of intervention) and at six months. All randomized participants who had complete baseline information were included in intention-to-treat analyses; participants with missing outcomes were coded as continuing smokers. Results Between April 2015 and August 2016, the trial enrolled 4190 participants. Eighteen were omitted because of missing baseline covariates and death before the primary endpoint, therefore 4172 participants were included in the intention-to-treat analyses. Programme acceptance was relatively high across all groups: 58.7% (2451/4172) overall and 61.3% (271/442) in the usual care group. Abstinence rates at 12 months did not differ among deposit programmes (336/2253, 14.9%) and non-deposit programmes (280/1919, 14.6%; adjusted difference 0.8 points, 95% confidence interval −2.7 to 4.3, P=0.65), but were somewhat lower for team based programmes (176/1348, 13.1%) than individual based programmes (440/2824, 15.6%; −3.2 points, −6.6 to −0.2, P=0.07), and higher for $40 bonus programmes (322/1954, 16.5%) than programmes with no bonus (148/1198, 12.4%; 5.9 points, 2.1 to 9.7, P=0.002). The $40 individual bonus was the most efficacious randomization group at all endpoints. Intervention components did not strongly interact with each other. Conclusions Acceptance of monetary incentive programmes for promoting smoking abstinence was high across all groups. The $40 individual bonus programmes increased long term smoking abstinence compared with usual care, although several other incentive designs did not, such as team based programmes and deposit programmes. Incentive design in workplace wellness programmes might influence their effectiveness at reducing smoking rates in low resource settings. Trial registration ClinicalTrials.gov ( NCT02421224 ).

scholarly journals A cluster-randomized trial of workplace ergonomics and neck-specific exercise versus ergonomics and health promotion for office workers to manage neck pain—a secondary outcome analysis

2020 ◽  
Author(s):  
Venerina Johnston ◽  
Xiaoqi Chen ◽  
Alyssa Welch ◽  
Gisela Sjøgaard ◽  
Tracy A Comans ◽  
...  
Keyword(s):  
Health Promotion ◽  
Neck Pain ◽  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Office Workers ◽  
Secondary Outcome ◽  
Outcome Analysis ◽  
Specific Exercise ◽  
Cluster Randomized

Abstract The authors have withdrawn this preprint due to author disagreement.

scholarly journals Acquisition of Antibiotic-Resistant Gram-negative Bacteria in the Benefits of Universal Glove and Gown (BUGG) Cluster Randomized Trial

2020 ◽  
Author(s):  
Anthony D Harris ◽  
Daniel J Morgan ◽  
Lisa Pineles ◽  
Larry Magder ◽  
Lyndsay M O’Hara ◽  
...  
Keyword(s):  
Intensive Care ◽  
Randomized Trial ◽  
Primary Outcome ◽  
Secondary Analysis ◽  
Cluster Randomized Trial ◽  
Gram Negative Bacteria ◽  
Antibiotic Resistant ◽  
Gram Negative ◽  
Carbapenem Resistant ◽  
Cluster Randomized

Abstract Background The Benefits of Universal Glove and Gown (BUGG) cluster randomized trial found varying effects on methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococcus and no increase in adverse events. The aim of this study was to assess whether the intervention decreases the acquisition of antibiotic-resistant gram-negative bacteria. Methods This was a secondary analysis of a randomized trial in 20 hospital intensive care units. The intervention consisted of healthcare workers wearing gloves and gowns when entering any patient room compared to standard care. The primary composite outcome was acquisition of any antibiotic-resistant gram-negative bacteria based on surveillance cultures. Results A total of 40 492 admission and discharge perianal swabs from 20 246 individual patient admissions were included in the primary outcome. For the primary outcome of acquisition of any antibiotic-resistant gram-negative bacteria, the intervention had a rate ratio (RR) of 0.90 (95% confidence interval [CI], .71–1.12; P = .34). Effects on the secondary outcomes of individual bacteria acquisition were as follows: carbapenem-resistant Enterobacteriaceae (RR, 0.86 [95% CI, .60–1.24; P = .43), carbapenem-resistant Acinetobacter (RR, 0.81 [95% CI, .52–1.27; P = .36), carbapenem-resistant Pseudomonas (RR, 0.88 [95% CI, .55–1.42]; P = .62), and extended-spectrum β-lactamase–producing bacteria (RR, 0.94 [95% CI, .71–1.24]; P = .67). Conclusions Universal glove and gown use in the intensive care unit was associated with a non–statistically significant decrease in acquisition of antibiotic-resistant gram-negative bacteria. Individual hospitals should consider the intervention based on the importance of these organisms at their hospital, effect sizes, CIs, and cost of instituting the intervention. Clinical Trials Registration NCT01318213.

scholarly journals Timing of Antihypertensive Medications on Key Outcomes in Hemodialysis (TAKE-HOLD): a Cluster Randomized Trial

Kidney360 ◽  
2021 ◽  
pp. 10.34067/KID.0001922021
Author(s):  
Tara I. Chang ◽  
Emily Tamar Tatoian ◽  
Maria E. Montez-Rath ◽  
Glenn M. Chertow
Keyword(s):  
Randomized Trial ◽  
Primary Outcome ◽  
Dry Weight ◽  
Cluster Randomized Trial ◽  
Uncontrolled Hypertension ◽  
Intradialytic Hypotension ◽  
Antihypertensive Medications ◽  
Dialysis Unit ◽  
Once Daily ◽  
Cluster Randomized

Background: We conducted this study to examine the effect of taking versus holding blood pressure (BP) medications prior to hemodialysis on intradialytic hypotension (IDH). Methods: In this cluster randomized trial, each dialysis unit was randomly designated as TAKE or HOLD units. Participants within a TAKE unit were instructed to take all BP medications as prescribed, while participants within a HOLD unit were instructed to hold medications dosed more than once daily prior to hemodialysis. The intervention lasted for 4 weeks. We hypothesized that TAKE would be non-inferior to HOLD on the primary outcome of asymptomatic IDH, defined as ≥30% of sessions with nadir systolic BP < 90 mm Hg and on the following secondary outcomes: uncontrolled hypertension (pre-dialysis systolic BP > 160 mm Hg), failure to achieve dry weight and shortened dialysis sessions. Results: We randomized 10 dialysis units in a 1:1 ratio to TAKE or HOLD, which included 65 participants in TAKE and 66 participants in HOLD. We did not show that TAKE was non-inferior to HOLD for the primary IDH outcome (mean unadjusted difference of 7.9%; CI -3.0% to 18.7%). TAKE was superior to HOLD for the outcome of uncontrolled hypertension (mean unadjusted difference of -14.6%, CI -28.0% to -1.2%). TAKE was non-inferior to HOLD for the outcomes of failure to achieve dry weight and shortened dialysis sessions. Conclusions: In this cluster randomized trial that randomized patients to either taking or holding BP medications before hemodialysis, a strategy of taking BP medications dosed more than once daily was not non-inferior to holding BP medications for the primary outcome of IDH, but did reduce the occurrence of uncontrolled hypertension. Whether any potential benefit of holding BP medications on reducing IDH is offset by any potential harms related to higher pre-dialysis BP remains to be seen.

scholarly journals The Acute Kidney Outreach to Prevent Deterioration and Death trial: a large pilot study for a cluster-randomized trial

2019 ◽  
Author(s):  
Mark E Thomas ◽  
Tarek S Abdelaziz ◽  
Gavin D Perkins ◽  
Alice J Sitch ◽  
Jyoti Baharani ◽  
...  
Keyword(s):  
Pilot Study ◽  
Randomized Trial ◽  
Primary Outcome ◽  
Cluster Randomized Trial ◽  
Teaching Hospitals ◽  
Specialist Care ◽  
Outreach Service ◽  
Intervention Hospital ◽  
Catchment Areas ◽  
Cluster Randomized

Abstract Background and Objectives The Acute Kidney Outreach to Reduce Deterioration and Death trial was a large pilot study for a cluster-randomized trial of acute kidney injury (AKI) outreach. Methods An observational control (before) phase was conducted in two teaching hospitals (9 miles apart) and their respective catchment areas. In the intervention (after) phase, a working-hours AKI outreach service operated for the intervention hospital/area for 20 weeks, with the other site acting as a control. All AKI alerts in both hospital and community patients were screened for inclusion. Major exclusion criteria were patients who were at the end of life, unlikely to benefit from outreach, lacking mental capacity or already referred to the renal team. The intervention arm included a model of escalation of renal care to AKI patients, depending on AKI stage. The 30-day primary outcome was a combination of death, or deterioration, as shown by any need for dialysis or progression in AKI stage. A total of 1762 adult patients were recruited; 744 at the intervention site during the after phase. Results A median of 3.0 non-medication recommendations and 0.5 medication-related recommendations per patient were made by the outreach team a median of 15.7 h after the AKI alert. Relatively low rates of the primary outcomes of death within 30 days (11–15%) or requirement for dialysis (0.4–3.7%) were seen across all four groups. In an exploratory analysis, at the intervention hospital during the after phase, there was an odds ratio for the combined primary outcome of 0.73 (95% confidence interval 0.42–1.26; P = 0.26). Conclusions An AKI outreach service can provide standardized specialist care to those with AKI across a healthcare economy. Trials assessing AKI outreach may benefit from focusing on those patients with ‘mid-range’ prognosis, where nephrological intervention could have the most impact.

scholarly journals Improving Tuberculosis Preventive Therapy Uptake: A Cluster-randomized Trial of Symptom-based Versus Tuberculin Skin Test–based Screening of Household Tuberculosis Contacts Less Than 5 Years of Age

2019 ◽  
Vol 70 (8) ◽  
pp. 1725-1732
Author(s):  
Nicole Salazar-Austin ◽  
Silvia Cohn ◽  
Grace Link Barnes ◽  
Molefi Tladi ◽  
Katlego Motlhaoleng ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Skin Testing ◽  
Cluster Randomized Trial ◽  
Preventive Therapy ◽  
World Health ◽  
Contact Tracing ◽  
Tuberculin Skin Testing ◽  
Symptom Screening ◽  
Significant Difference ◽  
Cluster Randomized

Abstract Background Tuberculosis preventive therapy (TPT) is highly effective at preventing tuberculosis disease in household child contacts (&lt;5 years), but is poorly implemented worldwide. In 2006, the World Health Organization recommended symptom-based screening as a replacement for tuberculin skin testing (TST) to simplify contact evaluation and improve implementation. We aimed to determine the effectiveness of this recommendation. Methods We conducted a pragmatic, cluster-randomized trial to determine whether contact evaluation using symptom screening improved the proportion of identified child contacts who initiated TPT, compared to TST-based screening, in Matlosana, South Africa. We randomized 16 clinics to either symptom-based or TST-based contact evaluations. Outcome data were abstracted from customized child contact management files. Results Contact tracing identified 550 and 467 child contacts in the symptom and TST arms, respectively (0.39 vs 0.32 per case, respectively; P = .27). There was no significant difference by arm in the adjusted proportion of identified child contacts who were screened (52% in symptom arm vs 60% in TST arm; P = .39). The adjusted proportion of identified child contacts who initiated TPT or tuberculosis treatment was 51.5% in the symptom clinics and 57.1% in the TST clinics (difference −5.6%, 95% confidence interval −23.7 to 12.6; P = .52). Based on the district’s historic average of 0.7 child contacts per index case, 14% and 15% of child contacts completed 6 months of TPT in the symptom and TST arms, respectively (P = .89). Conclusions Symptom-based screening did not improve the proportion of identified child contacts evaluated or initiated on TPT, compared to TST-based screening. Further research is needed to identify bottlenecks and evaluate interventions to ensure all child contacts receive TPT. Clinical Trials Registration NCT03074799.

scholarly journals Does Chlorhexidine Bathing in Adult Intensive Care Units Reduce Blood Culture Contamination? A Pragmatic Cluster-Randomized Trial

2014 ◽  
Vol 35 (S3) ◽  
pp. S17-S22 ◽  
Author(s):  
Edward J. Septimus ◽  
Mary K. Hayden ◽  
Ken Kleinman ◽  
Taliser R. Avery ◽  
Julia Moody ◽  
...  
Keyword(s):  
Intensive Care ◽  
Blood Culture ◽  
Randomized Trial ◽  
Cluster Randomized Trial ◽  
Baseline Period ◽  
Blood Cultures ◽  
Contamination Rate ◽  
Intervention Period ◽  
Significant Difference ◽  
Cluster Randomized

Objective.To determine rates of blood culture contamination comparing 3 strategies to prevent intensive care unit (ICU) infections: screening and isolation, targeted decolonization, and universal decolonization.Design.Pragmatic cluster-randomized trial.Setting.Forty-three hospitals with 74 ICUs; 42 of 43 were community hospitals.Patients.Patients admitted to adult ICUs from July 1, 2009, to September 30, 2011.Methods.After a 6-month baseline period, hospitals were randomly assigned to 1 of 3 strategies, with all participating adult ICUs in a given hospital assigned to the same strategy. Arm 1 implemented methicillin-resistantStaphylococcus aureus(MRSA) nares screening and isolation, arm 2 targeted decolonization (screening, isolation, and decolonization of MRSA carriers), and arm 3 conducted no screening but universal decolonization of all patients with mupirocin and chlorhexidine (CHG) bathing. Blood culture contamination rates in the intervention period were compared to the baseline period across all 3 arms.Results.During the 6-month baseline period, 7,926 blood cultures were collected from 3,399 unique patients: 1,099 sets in arm 1, 928 in arm 2, and 1,372 in arm 3. During the 18-month intervention period, 22,761 blood cultures were collected from 9,878 unique patients: 3,055 sets in arm 1, 3,213 in arm 2, and 3,610 in arm 3. Among all individual draws, for arms 1,2, and 3, the contamination rates were 4.1%, 3.9%, and 3.8% for the baseline period and 3.3%, 3.2%, and 2.4% for the intervention period, respectively. When we evaluated sets of blood cultures rather than individual draws, the contamination rate in arm 1 (screening and isolation) was 9.8% (N= 108 sets) in the baseline period and 7.5% (N= 228) in the intervention period. For arm 2 (targeted decolonization), the baseline rate was 8.4% (N= 78) compared to 7.5% (N= 241) in the intervention period. Arm 3 (universal decolonization) had the greatest decrease in contamination rate, with a decrease from 8.7% (N= 119) contaminated blood cultures during the baseline period to 5.1% (N= 184) during the intervention period. Logistic regression models demonstrated a significant difference across the arms when comparing the reduction in contamination between baseline and intervention periods in both unadjusted (P= .02) and adjusted (P= .02) analyses. Arm 3 resulted in the greatest reduction in blood culture contamination rates, with an unadjusted odds ratio (OR) of 0.56 (95% confidence interval [CI], 0.044-0.71) and an adjusted OR of 0.55 (95% CI, 0.43-0.71).Conclusion.In this large cluster-randomized trial, we demonstrated that universal decolonization with CHG bathing resulted in a significant reduction in blood culture contamination.

Effects of a Knowledge-Translation Intervention on Early Dialysis Initiation: A Cluster Randomized Trial

2021 ◽  
pp. ASN.2020091254
Author(s):  
Navdeep Tangri ◽  
Amit X. Garg ◽  
Thomas W. Ferguson ◽  
Stephanie Dixon ◽  
Claudio Rigatto ◽  
...  
Keyword(s):  
Knowledge Translation ◽  
Randomized Trial ◽  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Dialysis Initiation ◽  
Secondary Outcome ◽  
Control Group ◽  
Inpatient Setting ◽  
Link Type ◽  
Cluster Randomized

BackgroundThe Initiating Dialysis Early and Late (IDEAL) trial, published in 2009, found no clinically measurable benefit with respect to risk of mortality or early complications with early dialysis initiation versus deferred dialysis start. After these findings, guidelines recommended an intent-to-defer approach to dialysis initiation, with the goal of deferring it until clinical symptoms arise.MethodsTo evaluate a four-component knowledge translation intervention aimed at promoting an intent-to-defer strategy for dialysis initiation, we conducted a cluster randomized trial in Canada between October 2014 and November 2015. We randomized 55 clinics, 27 to the intervention group and 28 to the control group. The educational intervention, using knowledge-translation tools, included telephone surveys from a knowledge-translation broker, a 1-year center-specific audit with feedback, delivery of a guidelines package, and an academic detailing visit. Participants included adults who had at least 3 months of predialysis care and who started dialysis in the first year after the intervention. The primary efficacy outcome was the proportion of patients who initiated dialysis early (at eGFR >10.5 ml/min per 1.73 m2). The secondary outcome was the proportion of patients who initiated in the acute inpatient setting.ResultsThe analysis included 3424 patients initiating dialysis in the 1-year follow-up period. Of these, 509 of 1592 (32.0%) in the intervention arm and 605 of 1832 (33.0%) in the control arm started dialysis early. There was no difference in the proportion of individuals initiating dialysis early or in the proportion of individuals initiating dialysis as an acute inpatient.ConclusionsA multifaceted knowledge translation intervention failed to reduce the proportion of early dialysis starts in patients with CKD followed in multidisciplinary clinics.Clinical Trial registry name and registration number:ClinicalTrials.gov, NCT02183987. Available at: https://clinicaltrials.gov/ct2/show/NCT02183987

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