scholarly journals 128Study data within systematic reviews of intensive care interventions analysed as a cluster randomized trial

2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
James Hurley
Keyword(s):  
Systematic Reviews ◽  
Prolonged Mechanical Ventilation ◽  
Intervention Group ◽  
Population Level ◽  
Cluster Randomized Trial ◽  
Contextual Effect ◽  
Control Groups ◽  
Topical Antibiotics ◽  
Concurrent Control ◽  
Cluster Randomized

Abstract Focus of Presentation Cluster randomized trials (CRT) can address infectious disease research questions at the whole-of-population level, such as herd protection and herd peril effects, that cannot be answered within randomized controlled trials. For adequate power, ideally, a CRT will have at least 40 clusters. Findings Studies of decontamination (using either chlorhexidine or topical antibiotics) to prevent ICU-acquired infections among adult patients requiring prolonged mechanical ventilation (MV) have been summarized in > 15 systematic reviews. Of 83 studies of topical antibiotics, 69 had concurrent control (CC) versus non-concurrent control (NCC; n = 14) design (Figure below; solid symbols are intervention group patients). The mean ICU pneumonia incidence for topical antibiotic study CC control groups (34.5%; 95% CI, 29.1-40.4) is higher versus a literature benchmark (26.1%; 23.3%-29.1%), and versus NCC control groups (29.9%; 21.4-40.4) and versus chlorhexidine study CC control groups (25.5%; 19.6 – 32.5; n = 17). Conclusions/Implications Benchmarking the event rates among control groups versus the event rate among non-intervention studies for MV patients provide a measure of the contextual effect of the intervention. Differing intervention effects for studies with CC versus NCC design implicates herd effects. Key messages Systematic reviews of interventions that include studies with CC versus NCC design provide a natural experiment of contextual effects where their study otherwise would be difficult or, for adverse herd effects, unethical.

scholarly journals 127Topical antibiotics used to prevent infection in the ICU: an accidental natural herd exposure experiment

2021 ◽  
Vol 50 (Supplement_1) ◽  
Author(s):  
James Hurley
Keyword(s):  
Systematic Reviews ◽  
Infection Prevention ◽  
Intervention Group ◽  
Control Group ◽  
Control Groups ◽  
Topical Antibiotic ◽  
Herd Effect ◽  
Icu Patients ◽  
Topical Antibiotics ◽  
Prevention Methods

Abstract Background Multiple studies of topical antibiotics applied to ICU patients appear to show potent infection prevention effects versus studies of other interventions. However, the effect is less apparent for studies using non-concurrent (NCC) versus concurrent controls (CC) implying the possibility of a herd effect. Methods 206 studies of infection prevention among ICU patients, sourced from 15 systematic reviews were stratified into those using topical antibiotics with NCC versus with CC versus studies of other prevention methods. The event rates were summarised using generalized estimating equations and compared to other studies without an intervention (literature benchmark). Results The summary effect sizes for pneumonia and mortality prevention derived in the systematic reviews were replicated. The mean ICU mortality incidence for topical antibiotic study CC control groups (28.5%; 95% CI, 25.0-32.3; n = 41) is higher versus a literature benchmark (23.7%; 19.2%-28.5%; n = 34), versus NCC control groups (23.5%; 19.3-28.3; n = 14) and versus topical antibiotic intervention groups (24.4%; 22.1 – 26.9; n = 62). In meta-regression models adjusted for group mean age and publication year, CC group membership within a topical antibiotic study remains associated with higher mortality (p = 0.027). Conclusions Within topical antibiotic studies, the CC control group mortality incidences are inexplicably high, whereas the intervention group incidences are paradoxically similar to a literature-derived benchmark. Key messages An adverse herd effect is apparent for topical antibiotics used to prevent infection among ICU patients.

scholarly journals The Effect of a Priest-Led Intervention on the Choice and Preference of Soda Beverages: A Cluster-Randomized Controlled Trial in Catholic Parishes

2019 ◽  
Vol 54 (6) ◽  
pp. 436-446
Author(s):  
J Jaime Miranda ◽  
Alvaro Taype-Rondan ◽  
Janina Bazalar-Palacios ◽  
Antonio Bernabe-Ortiz ◽  
Dan Ariely
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Nonparametric Tests ◽  
Control Groups ◽  
Innovative Strategies ◽  
Sugary Drinks ◽  
Cluster Randomized ◽  
Sugary Beverages ◽  
And Control

Abstract Background Latin America ranks among the regions with the highest level of intake of sugary beverages in the world. Innovative strategies to reduce the consumption of sugary drinks are necessary. Purpose Evaluate the effect of a one-off priest-led intervention on the choice and preference of soda beverages. Methods We conducted a pragmatic cluster-randomized trial in Catholic parishes, paired by number of attendees, in Chimbote, Peru between March and June of 2017. The priest-led intervention, a short message about the importance of protecting one’s health, was delivered during the mass. The primary outcome was the proportion of individuals that choose a bottle of soda instead of a bottle of water immediately after the service. Cluster-level estimates were used to compare primary and secondary outcomes between intervention and control groups utilizing nonparametric tests. Results Six parishes were allocated to control and six to the intervention group. The proportion of soda selection at baseline was ~60% in the intervention and control groups, and ranged from 56.3% to 63.8% in Week 1, and from 62.7% to 68.2% in Week 3. The proportion of mass attendees choosing water over soda was better in the priest-led intervention group: 8.2% higher at Week 1 (95% confidence interval 1.7%–14.6%, p = .03), and 6.2% higher at 3 weeks after baseline (p = .15). Conclusions This study supports the proof-of-concept that a brief priest-led intervention can decrease sugary drink choice. Clinical Trial information ISRCTN, ISRCTN24676734. Registered 25 April 2017, https://www.isrctn.com/ISRCTN24676734

Evaluation of a social media campaign to increase COVID-19 testing in migrant groups: A cluster randomized trial (Preprint)

2021 ◽  
Author(s):  
Ingeborg Hess Elgersma ◽  
Atle Fretheim ◽  
Thor Indseth ◽  
Anita Thorolvsen Munch ◽  
Live Bøe Johannessen ◽  
...  
Keyword(s):  
Social Media ◽  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Control Group ◽  
Media Campaign ◽  
Predicted Probability ◽  
Simple Language ◽  
Media Intervention ◽  
Cluster Randomized ◽  
Migrant Groups

BACKGROUND A low test positivity rate is key to keeping the COVID-19 pandemic under control. Several migrant groups in Norway have seen higher rates of confirmed COVID-19 and related hospitalizations, while test positivity has remained high in the same groups. Social media sponsored ads have been an important part of the government’s strategy to reach these groups. OBJECTIVE In this study we aimed to investigate whether such a targeted Facebook campaign increased the rate of testing in certain migrant groups. METHODS We randomly assigned 386 Norwegian municipalities and city districts, to intervention or control groups. Individuals born in Syria, Pakistan, Eritrea, Turkey, Russia and Iraq residing in intervention areas were targeted with a social media campaign aiming at increasing the COVID-19 test rate. The campaign message was in simple language and conveyed in the users’ main language or in English. RESULTS During the follow-up period of two weeks, the predicted probability of conducting a COVID-19 test was 4.82 % (CI: 4.47 % - 5.18 %) in the control group, and 5.58 % (CI: 5.20 % - 5.99 %) in the intervention group (P=.004). CONCLUSIONS Our targeted social media intervention led to a modest, but potentially important, increase in test rates among migrants in Norway. CLINICALTRIAL ClinicalTrials.gov Identifier NCT04866589.

The Effect of Theory-lead Intervention for Knee Osteoarthritis in Older Adults: A Cluster Randomized Trial

2020 ◽  
Author(s):  
Limin Wang ◽  
Hongbo Chen ◽  
Han Lu ◽  
Yunlin Wang ◽  
Congying Liu ◽  
...  
Keyword(s):  
Older Adults ◽  
Knee Osteoarthritis ◽  
Transtheoretical Model ◽  
Intervention Group ◽  
Exercise Program ◽  
Exercise Adherence ◽  
Cluster Randomized Trial ◽  
Knee Function ◽  
Control Group ◽  
Cluster Randomized

Abstract Background: Knee osteoarthritis (KOA) is a common joint disease in people over 60 years old. Exercise therapy is one of the most effective non-pharmacological treatments for KOA, but low exercise adherence needs to be improved. The present study aimed to evaluate the effect of the transtheoretical model-lead home exercise intervention (TTM-HEI) program on exercise adherence, KOA symptoms and knee function in older adults with KOA. Methods: A two-arm, superiority, assessor-blinded, cluster randomized trial was conducted. Community-dwelling older adults with KOA were recruited from 14 community centers in Beijing, China via print and social media advertisements from April to October 2018. The intervention was a two-stage and 24-week transtheoretical model-based exercise program, and the control group underwent a same length but non-theory-based exercise program. Exercise adherence was measured by an 11-point numerical self-rating scale at weeks 4, 12, 24, 36, and 48 after the program started. KOA symptoms (pain intensity and joint stiffness) and knee function (lower limb muscle strength and balance) were measured at baseline, week 24, and week 48. Latent growth model (GLM), repeated measures ANOVA and independent t-test were the main statistical tests.Results: A total of 189 older adults (intervention group: n = 103, control group: n = 86) were enrolled. Differences of any outcome measures at baseline were not significant between groups. The growth rate of exercise adherence in the intervention group increased 2.175 units compared with the control group (unstandardized coefficient of slope on group B2 = 2.175, p < 0.001), and the intervention program maintained participants’ exercise adherence with 5.56 (SD = 1.00) compared with 3.16 (SD = 1.31) in the control group at week 48. In addition, TTM-HEI program showed significant effects on relieving KOA symptoms and improving knee function.Conclusion: The TTM-HEI could improve the participants’ exercise adherence, knee osteoarthritis symptoms and knee function over time.

scholarly journals Long term outcomes of cluster randomized trial to improve cardiovascular health at population level: The Cardiovascular Health Awareness Program (CHAP)

PLoS ONE ◽  
2018 ◽  
Vol 13 (9) ◽  
pp. e0201802 ◽  
Author(s):  
Simone Dahrouge ◽  
Janusz Kaczorowski ◽  
Lisa Dolovich ◽  
Michael Paterson ◽  
Lehana Thabane ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Cardiovascular Health ◽  
Population Level ◽  
Cluster Randomized Trial ◽  
Health Awareness ◽  
Long Term Outcomes ◽  
Awareness Program ◽  
Cluster Randomized

scholarly journals Implementation of French Recommendations for the Prevention and the Treatment of Hospital-acquired Pneumonia: A Cluster-randomized Trial

2020 ◽  
Author(s):  
Antoine Roquilly ◽  
Gérald Chanques ◽  
Sigismond Lasocki ◽  
Arnaud Foucrier ◽  
Brice Fermier ◽  
...  
Keyword(s):  
Randomized Trial ◽  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Baseline Period ◽  
Audit And Feedback ◽  
Control Group ◽  
Icu Stay ◽  
Hospital Acquired Pneumonia ◽  
Cluster Randomized ◽  
Hospital Acquired

Abstract Background We determined whether an audit on the adherence to guidelines for hospital-acquired pneumonia (HAP) can improve the outcomes of patients in intensive care units (ICUs). Methods This study was conducted at 35 ICUs in 30 hospitals. We included consecutive, adult patients hospitalized in ICUs for 3 days or more. After a 3-month baseline period followed by the dissemination of recommendations, an audit on the compliance to recommendations (audit period) was followed by a 3-month cluster-randomized trial. We randomly assigned ICUs to either receive audit and feedback (intervention group) or participate in a national registry (control group). The primary outcome was the duration of ICU stay. Results Among 1856 patients enrolled, 602, 669, and 585 were recruited in the baseline, audit, and intervention periods, respectively. The composite measures of compliance were 47% (interquartile range [IQR], 38–56%) in the intervention group and 42% (IQR, 25–53%) in the control group (P = .001). As compared to the baseline period, the ICU lengths of stay were reduced by 3.2 days in the intervention period (P = .07) and by 2.8 days in the control period (P = .02). The durations of ICU stay were 7 days (IQR, 5–14 days) in the control group and 9 days (IQR, 5–20 days) in the intervention group (P = .10). After adjustment for unbalanced baseline characteristics, the hazard ratio for being discharged alive from the ICU in the control group was 1.17 (95% confidence interval, .69–2.01; P = .10). Conclusions The publication of French guidelines for HAP was associated with a reduction of the ICU length of stay. However, the realization of an audit to improve their application did not further improve outcomes. Clinical Trials Registration NCT03348579.

Effect of a Community-led Total Sanitation Intervention on the Incidence and Prevalence of Diarrhea in Children in Rural Ethiopia: A Cluster-randomized Controlled Trial

2021 ◽  
Author(s):  
Seungman Cha ◽  
Sunghoon Jung ◽  
Dawit Belew Bizuneh ◽  
Tadesse Abera ◽  
Young-Ah Doh ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Prevalence Ratio ◽  
Cluster Randomized Trial ◽  
Control Group ◽  
Period Prevalence ◽  
Rural Villages ◽  
Diary Methods ◽  
Diarrhea Incidence ◽  
Cluster Randomized

We conducted a cluster-randomized trial in 48 rural villages of Ethiopia to assess the effect of community-led total sanitation (CLTS) on the diarrhea incidence of children. Twenty-four villages were randomly assigned to the intervention group and the other 24 were assigned to the control group. A CLTS intervention was implemented from January 2016 through January 2017. Baseline data collection was conducted during October and November 2015. At baseline, 906 children were recruited and followed-up until January 2017. These 906 children were randomly selected among all children in the 48 villages. To determine the 7-day period prevalence of diarrhea, four household-based surveys were conducted by independent data collectors at 3, 5, 9, and 10 months after the CLTS was initiated. To determine the incidence and longitudinal prevalence, the presence of daily diarrhea presence was recorded for 140 days using diary methods. The loss to follow-up rates were 95% for period prevalence and 93% for incidence and longitudinal prevalence. The incidence ratio and longitudinal prevalence ratio were 0.66 (95% confidence interval [CI], 0.45–0.97; P = 0.03) and 0.70 (95% CI, 0.52–0.95; P = 0.02) after adjusting for clustering and stratification. The relative risk of period prevalence was 0.66 (95% CI, 0.45–0.98; P = 0.04) at 3 months after initiation. Improved toilet coverage increased from 0.0% at baseline to 35.0% at 10 months in the intervention villages, whereas it increased from 0.7% to 2.8% in the control villages. Adherence to the intervention was comparable with that of previous studies; therefore, we suggest that the findings of this study are replicable.

The Effect of Transtheoretical Model-lead Intervention for Knee Osteoarthritis in Older Adults: A Cluster Randomized Trial

2020 ◽  
Author(s):  
Limin Wang ◽  
Hongbo Chen ◽  
Han Lu ◽  
Yunlin Wang ◽  
Congying Liu ◽  
...  
Keyword(s):  
Older Adults ◽  
Transtheoretical Model ◽  
Intervention Group ◽  
Exercise Program ◽  
Exercise Adherence ◽  
Cluster Randomized Trial ◽  
Knee Function ◽  
Home Exercise ◽  
Control Group ◽  
Cluster Randomized

Abstract Background: Knee osteoarthritis (KOA) is a common joint disease in people over 60 years old. Exercise therapy is one of the most effective non-pharmacological treatments for KOA, but low exercise adherence needs to be improved. The present study aimed to evaluate the effect of the Transtheoretical Model-lead home exercise intervention (TTM-HEI) program on exercise adherence, KOA symptoms, and knee function in older adults with KOA. Methods: A two-arm, superiority, assessor-blinded, cluster randomized trial was conducted. Community-dwelling older adults with KOA were recruited from 14 community centers in Beijing, China, via print and social media advertisements from April to October 2018. The present study lasted 48 weeks, with an intervention duration of 0–24 weeks and follow-up time of 24–48 weeks. The intervention was a two-stage and 24-week TTM-based exercise program, and the control group underwent a same-length exercise program guidance without any exercise-adherence interventions. The primary outcome was exercise adherence to the prescribed home exercise program and was measured using an 11-point numerical (0=not at all through and 10=completely as instructed) self-rating scale at week 4, 12, 24, 36, and 48 after the program started. KOA symptoms (pain intensity and joint stiffness) were measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and knee function (lower limb muscle strength and balance) was measured using the Five-Times-Sit-to-Stand Test (FTSST) and the Timed Up and Go Test (TUG) at baseline, week 24 and week 48. Latent growth model (GLM), repeated measures ANOVA, and independent t-test were the main statistical tests used.Results: A total of 189 older adults (intervention group: n = 103, control group: n = 86) were enrolled. Differences of any outcome measures at baseline were not significant between groups. The growth rate of exercise adherence in the intervention group increased 2.175 units compared with the control group (unstandardized coefficient of slope on group B2 = 2.175, p < 0.001), and the intervention program maintained participants’ exercise adherence with 5.56 (SD = 1.00) compared with 3.16 (SD = 1.31) in the control group at week 48. In addition, TTM-HEI program showed significant effects on relieving KOA symptoms and improving knee function.Conclusion: Over time, TTM-HEI could improve participants’ exercise adherence, KOA symptoms, and knee function.Trial registration: This study was approved by the ethics committee (IRB00001052-17066) in July 2017 and was registered at Chinese Clinical Trails Registry (website: www.chictr.org.cn, registry number: ChiCTR1800015458).

Apathy in Nursing Home Residents with Dementia: Results From A Cluster-Randomized Controlled Trial

2015 ◽  
Vol 30 (2) ◽  
pp. 251-257 ◽  
Author(s):  
Y. Treusch ◽  
T. Majic ◽  
J. Page ◽  
H. Gutzmann ◽  
A. Heinz ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Intervention Group ◽  
Nursing Home Residents ◽  
Cluster Randomized Trial ◽  
Control Group ◽  
Intervention Period ◽  
Significant Group ◽  
Dementia Patients ◽  
Cluster Randomized ◽  
One Year

AbstractPurpose:Here we evaluate an interdisciplinary occupational and sport therapy intervention for dementia patients suffering from apathy.Subjects and methods:A prospective, controlled, rater-blinded, clinical trial with two follow-ups was conducted as part of a larger cluster-randomized trial in 18 nursing homes in Berlin. n = 117 dementia patients with apathy, defined as a score of 40 or more on the apathy evaluation scale (AES) or presence of apathy on the Neuropsychiatric Inventory (NPI), were randomly assigned to intervention or control group. The intervention included 10 months of brief activities, provided once a week. The primary outcome measure was the total score on the AES scale measured directly after the intervention period and again after 12 months.Results:We found significant group differences with respect to apathy during the 10 month intervention period (F2,82 = 7.79, P < 0.01), which reflected an increase in apathy in the control group, but not in the intervention group. Within one year after the intervention was ceased, the treatment group worsened and no longer differed significantly from the control group (P = 0.55).Conclusions:Our intervention was effective for the therapy of apathy in dementia, when applied, but not one year after cessation of therapy.

Abstract 19: Impacts of the Million Hearts® Cardiovascular Disease Risk Reduction Model on the Initiation or Intensification of Statins and Anti-hypertensive Medications: A Pragmatic, Cluster-randomized Trial

2020 ◽  
Vol 13 (Suppl_1) ◽  
Author(s):  
G. G Peterson ◽  
Jia Pu ◽  
David J Magid ◽  
Linda Barterian ◽  
Michael Barna ◽  
...  
Keyword(s):  
High Risk ◽  
Risk Reduction ◽  
Risk Group ◽  
Intervention Group ◽  
Cluster Randomized Trial ◽  
Medicare Beneficiaries ◽  
Cvd Risk ◽  
Percentage Points ◽  
Medium Risk ◽  
Cluster Randomized

Introduction: The Million Hearts® Cardiovascular Disease (CVD) Risk Reduction Model pays providers for measuring cardiovascular risk among their Medicare beneficiaries and for reducing risk among their high-risk patients. The Centers for Medicare and Medicaid Services (CMS) is testing whether this model can improve cardiovascular care and reduce the incidence of first-time heart attacks and strokes over 5 years. This study assesses whether, in its first 2 years, the model (1) increased use of CVD medications among those with elevated blood pressure or cholesterol, and (2) increased provider awareness of CVD risks among their patients. Methods: In this pragmatic, cluster-randomized trial, CMS enrolled 516 organizations (primary and specialty practices, health centers, and hospitals) throughout the country and assigned half to the intervention group. Organizations enrolled beneficiaries (age 40-79 without a prior CVD event) during routine office visits. We linked enrollment and clinical data with Medicare Part D claims and estimated impacts as intervention-control differences in outcomes. We surveyed one randomly selected provider in each organization about their use of risk CVD stratification (70% response rate). Results: The intervention and control organizations enrolled 300,550 Medicare beneficiaries. In both groups, 18% of enrollees were high risk per CMS definitions (≥30% or higher risk of a heart attack or stroke in the next 10 years), 40% were medium risk (15-30% risk), and the remainder were low risk (<15% risk). While almost all high-risk enrollees were taking anti-hypertensive medications or statins at baseline, most (90%) had elevated blood pressure, cholesterol, or both. High-risk enrollees in the intervention group were 4 percentage points more likely than control enrollees (28 vs 24%, p<0.001) to initiate or intensify statins or anti-hypertensive medications within 6 months of enrollment. When including the larger medium-risk group—for whom CMS does not separately pay for CVD risk reduction—rates of initiation or intensification were 3 percentage points higher in the intervention versus control groups (23 vs 20%, p<0.001). According to the survey, intervention group providers were much more likely than control group providers to risk assess at least half of their Medicare patients (71 vs 39%, p<0.001). Most intervention group providers (73%) said that their greater use of risk stratification helped them better identify beneficiaries at risk of CVD events. Conclusions: The Million Hearts model significantly improved use of CVD medications among high-risk enrollees, mainly through intensification, and had positive spillover to the much larger medium risk group. These improvements were likely driven, at least partly, by providers become more aware of their patients’ CVD risk through greater use of risk stratification.

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