Targeted Antibiotics for Trachoma: A Cluster-Randomized Trial

Abstract Background Current guidelines recommend community-wide mass azithromycin for trachoma, but a targeted treatment strategy could reduce the volume of antibiotics required. Methods In total, 48 Ethiopian communities were randomized to mass, targeted, or delayed azithromycin distributions. In the targeted arm, only children aged 6 months to 5 years with evidence of ocular chlamydia received azithromycin, distributed thrice over the following year. The primary outcome was ocular chlamydia at months 12 and 24, comparing the targeted and delayed arms (0–5 year-olds, superiority analysis) and the targeted and mass azithromycin arms (8–12 year-olds, noninferiority analysis, 10% noninferiority margin). Results At baseline, the mean prevalence of ocular chlamydia in the 3 arms ranged from 7% to 9% among 0–5 year-olds and from 3% to 9% among 8–12 year-olds. Averaged across months 12–24, the mean prevalence of ocular chlamydia among 0–5 year-olds was 16.7% (95% confidence interval [CI]: 9.0%–24.4%) in the targeted arm and 22.3% (95% CI: 11.1%–33.6%) in the delayed arm (P = .61). The final mean prevalence of ocular chlamydia among 8–12 year-olds was 13.5% (95% CI: 7.9%–19.1%) in the targeted arm and 5.5% (95% CI: 0.3%–10.7%) in the mass treatment arm (adjusted risk difference 8.5 percentage points [pp] higher in the targeted arm, 95% CI: 0.9 pp–16.1 pp higher). Conclusions Antibiotic treatments targeted to infected preschool children did not result in significantly less ocular chlamydia infections compared with untreated communities and did not meet noninferiority criteria relative to mass azithromycin distributions. Targeted approaches may require treatment of a broader segment of the population in areas with hyperendemic trachoma.

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Azithromycin Reduction to Reach Elimination of Trachoma (ARRET): study protocol for a cluster randomized trial of stopping mass azithromycin distribution for trachoma

BMC Ophthalmology ◽

10.1186/s12886-020-01776-4 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Abdou Amza ◽

Boubacar Kadri ◽

Beido Nassirou ◽

Ahmed M. Arzika ◽

Ariana Austin ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Clinical Signs ◽

Cluster Randomized Trial ◽

World Health ◽

Baseline Assessment ◽

Randomized Controlled ◽

Registration Number ◽

Cluster Randomized ◽

Health Organization

Abstract Background The World Health Organization (WHO) recommends annual mass azithromycin distribution until districts drop below 5% prevalence of trachomatous inflammation—follicular (TF). Districts with very low TF prevalence may have little or no transmission of the ocular strains of Chlamydia trachomatis that cause trachoma, and additional rounds of mass azithromycin distribution may not be useful. Here, we describe the protocol for a randomized controlled trial designed to evaluate whether mass azithromycin distribution can be stopped prior to the current WHO guidelines. Methods The Azithromycin Reduction to Reach Elimination of Trachoma (ARRET) study is a 1:1 community randomized non-inferiority trial designed to evaluate whether mass azithromycin distribution can be stopped in districts with baseline prevalence of TF under 20%. Communities in Maradi, Niger are randomized after baseline assessment either to continued annual mass azithromycin distribution or stopping annual azithromycin distribution over a 3-year period. We will compare the prevalence of ocular C. trachomatis (primary outcome), TF and other clinical signs of trachoma, and serologic markers of trachoma after 3 years. We hypothesize that stopping annual azithromycin distribution will be non-inferior to continued annual azithromycin distributions for all markers of trachoma prevalence and transmission. Discussion The results of this trial are anticipated to provide potentially guideline-changing evidence for when mass azithromycin distributions can be stopped in low TF prevalence areas. Trial registration number This study is registered at clinicaltrials.gov (NCT04185402). Registered December 4, 2019; prospectively registered pre-results.

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Chronic use of tramadol after acute pain episode: cohort study

BMJ ◽

10.1136/bmj.l1849 ◽

2019 ◽

pp. l1849 ◽

Cited By ~ 27

Author(s):

Cornelius A Thiels ◽

Elizabeth B Habermann ◽

W Michael Hooten ◽

Molly M Jeffery

Keyword(s):

Acute Pain ◽

Elective Surgery ◽

Risk Difference ◽

Administrative Claims ◽

Opioid Use ◽

Short Acting ◽

Adjusted Risk ◽

Post Surgery ◽

Percentage Points ◽

Chronic Opioid Use

AbstractObjectiveTo determine the risk of prolonged opioid use in patients receiving tramadol compared with other short acting opioids.DesignObservational study of administrative claims data.SettingUnited States commercial and Medicare Advantage insurance claims (OptumLabs Data Warehouse) January 1, 2009 through June 30, 2018.ParticipantsOpioid-naive patients undergoing elective surgery.Main outcome measureRisk of persistent opioid use after discharge for patients treated with tramadol alone compared with other short acting opioids, using three commonly used definitions of prolonged opioid use from the literature: additional opioid use (defined as at least one opioid fill 90-180 days after surgery); persistent opioid use (any span of opioid use starting in the 180 days after surgery and lasting ≥90 days); and CONSORT definition (an opioid use episode starting in the 180 days after surgery that spans ≥90 days and includes either ≥10 opioid fills or ≥120 days’ supply of opioids).ResultsOf 444 764 patients who met the inclusion criteria, 357 884 filled a discharge prescription for one or more opioids associated with one of 20 included operations. The most commonly prescribed post-surgery opioid was hydrocodone (53.0% of those filling a single opioid), followed by short acting oxycodone (37.5%) and tramadol (4.0%). The unadjusted risk of prolonged opioid use after surgery was 7.1% (n=31 431) with additional opioid use, 1.0% (n=4457) with persistent opioid use, and 0.5% (n=2027) meeting the CONSORT definition. Receipt of tramadol alone was associated with a 6% increase in the risk of additional opioid use relative to people receiving other short acting opioids (incidence rate ratio 95% confidence interval 1.00 to 1.13; risk difference 0.5 percentage points; P=0.049), 47% increase in the adjusted risk of persistent opioid use (1.25 to 1.69; 0.5 percentage points; P<0.001), and 41% increase in the adjusted risk of a CONSORT chronic opioid use episode (1.08 to 1.75; 0.2 percentage points; P=0.013).ConclusionsPeople receiving tramadol alone after surgery had similar to somewhat higher risks of prolonged opioid use compared with those receiving other short acting opioids. Federal governing bodies should consider reclassifying tramadol, and providers should use as much caution when prescribing tramadol in the setting of acute pain as for other short acting opioids.

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Comparison of 3 Days Amoxicillin Versus 5 Days Co-Trimoxazole for Treatment of Fast-breathing Pneumonia by Community Health Workers in Children Aged 2–59 Months in Pakistan: A Cluster-randomized Trial

Clinical Infectious Diseases ◽

10.1093/cid/ciy918 ◽

2018 ◽

Vol 69 (3) ◽

pp. 397-404

Author(s):

Salim Sadruddin ◽

Ibad ul Haque Khan ◽

Matthew P Fox ◽

Abdul Bari ◽

Attaullah Khan ◽

...

Keyword(s):

Treatment Failure ◽

Health Workers ◽

Cluster Randomized Trial ◽

Risk Difference ◽

Community Level ◽

World Health ◽

Serious Adverse Events ◽

Oral Amoxicillin ◽

Cluster Randomized ◽

Health Organization

Abstract Background Globally, most deaths due to childhood pneumonia occur at the community level. Some countries are still using oral co-trimoxazole, despite a World Health Organization recommendation of oral amoxicillin for the treatment of fast-breathing pneumonia in children at the community level. Methods We conducted an unblinded, cluster-randomized, controlled-equivalency trial in Haripur District, Pakistan. Children 2–59 months of age with fast-breathing pneumonia were treated with oral amoxicillin suspension (50 mg/kg/day) for 3 days in 14 intervention clusters and oral co-trimoxazole suspension (8 mg trimethoprim/kg and 40 mg sulfamethoxazole/kg/day) for 5 days in 14 control clusters by lady health workers (LHW). The primary outcome was treatment failure by day 4 for intervention clusters and by day 6 for control clusters. The analysis was per protocol. Results Out of the 15 749 cases enrolled in the study, 9153 cases in intervention and 6509 cases in control clusters were included in the analysis. Treatment failure rates were 3.6% (326) in intervention clusters and 9.1% (592) in control clusters. After adjusting for clustering, the risk of treatment failure was lower in intervention clusters (risk diﬀerence [RD] -5.5%, 95% confidence interval [CI] -7.4–-3.7%) than in control clusters. Children with incomplete adherence had a small increase in treatment failure versus those with complete adherence (RD 2.9%, 95% CI 1.6–4.1%). No deaths or serious adverse events occurred. Conclusions A 3-day course of oral amoxicillin, administered by LHWs, is an effective and safe treatment for fast-breathing pneumonia in children 2–59 months of age. A shorter course of amoxicillin improves adherence to therapy, is low in cost, and puts less pressure on antimicrobial resistance. Clinical Trials Registration ISRCTN10618300.

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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

Circulation Cardiovascular Quality and Outcomes ◽

10.1161/hcq.13.suppl_1.19 ◽

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

Clinical Infectious Diseases ◽

10.1093/cid/ciaa071 ◽

2020 ◽

Cited By ~ 1

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.

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Intermittent preventive treatment of malaria delivered to primary schoolchildren provided effective individual protection in Jinja, Uganda: secondary outcomes of a cluster-randomized trial (START-IPT)

Malaria Journal ◽

10.1186/s12936-019-2954-0 ◽

2019 ◽

Vol 18 (1) ◽

Cited By ~ 1

Author(s):

Andrea M. Rehman ◽

Catherine Maiteki-Sebuguzi ◽

Samuel Gonahasa ◽

Jaffer Okiring ◽

Simon P. Kigozi ◽

...

Keyword(s):

Randomized Trial ◽

Intermittent Preventive Treatment ◽

Preventive Treatment ◽

Cluster Randomized Trial ◽

Adjusted Risk ◽

School Based ◽

Primary Schoolchildren ◽

Secondary Outcomes ◽

Cluster Randomized ◽

The Impact

Abstract Background Intermittent preventive treatment (IPT) of malaria is recommended as policy for certain high-risk populations, but not currently for schoolchildren. A cluster-randomized trial was conducted to evaluate the effect of IPT with dihydroartemisinin–piperaquine (DP) on primary schoolchildren in Jinja, Uganda. Results of the impact of IPT of schoolchildren on community-level transmission have been reported previously. Here, secondary outcomes from a school-based survey are presented. Methods Eighty-four clusters (one primary school plus 100 households) were randomized to intervention and control (1:1 ratio). Participants from intervention schools received monthly IPT with DP for up to 6 rounds (June–December 2014). At endline (November–December 2014), randomly selected children from all 84 schools were surveyed (13 per school) and thick blood smears were done. Those with fever or history of fever were tested with rapid diagnostic tests (RDTs) for malaria. Haemoglobin was measured in every fifth participant. Outcome measures included prevalence of asexual parasites and gametocytes (by microscopy), and prevalence of anaemia. Prevalence outcomes were analysed using generalized linear Poisson models with log link function, incorporating a cluster-level random intercept and quantified using prevalence risk ratios. Results Among 23,280 students listed on the 42 intervention school registers, 10,079 (43.3%) aged 5–20 years were enrolled into the IPT intervention and received at least one dose of DP; of these, 9286 (92.1%) received at least one full (3-day) course. In total, 1092 children were enrolled into the final school survey (546 per arm) and had a thick blood smear done; of these, 255 had haemoglobin measured (129 intervention, 126 control). Children in the intervention arm were less likely to have asexual parasites (9.2% intervention vs 44.1% control, adjusted risk ratio [aRR] 0.22 [95% CI 0.16–0.30] p < 0.001), gametocytes (3.1% intervention vs 9.5% control, aRR 0.34 [95% CI 0.20–0.56] p < 0.001), fever (20.2% intervention vs 56.2% control, aRR 0.35 [95% CI 0.25–0.50] p < 0.001), or symptomatic malaria (5.1% intervention vs 35.7% control, aRR 0.14 [95% CI 0.08–0.26] p < 0.001). Prevalence of anaemia and mean haemoglobin were similar in both study arms. Conclusions School-aged children are a major reservoir of malaria parasites. Delivering IPT to schoolchildren would benefit individual children and may reduce transmission. School-based IPT could help to intensify malaria control toward elimination, and should be considered for policies and programmes. Trial registration Clinicaltrials.gov (NCT02009215), Registered 11 December 2013. https://clinicaltrials.gov/ct2/show/NCT02009215

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

Kidney360 ◽

10.34067/kid.0001922021 ◽

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.

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

Nephrology Dialysis Transplantation ◽

10.1093/ndt/gfz246 ◽

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.

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The effect of a school-based intervention on physical activity, cardiorespiratory fitness and muscle strength: the School in Motion cluster randomized trial

International Journal of Behavioral Nutrition and Physical Activity ◽

10.1186/s12966-020-01060-0 ◽

2020 ◽

Vol 17 (1) ◽

Author(s):

Elin Kolle ◽

Runar Barstad Solberg ◽

Reidar Säfvenbom ◽

Sindre M. Dyrstad ◽

Sveinung Berntsen ◽

...

Keyword(s):

Physical Activity ◽

Muscle Strength ◽

Active Learning ◽

Cardiorespiratory Fitness ◽

Cluster Randomized Trial ◽

Control Group ◽

Physically Active ◽

School Based ◽

The Mean ◽

Cluster Randomized

Abstract Background Physical activity (PA) declines throughout adolescence, therefore PA promotion during this period is important. We analyzed the effect of two school-based PA interventions on daily PA levels, cardiorespiratory fitness (CRF) and muscle strength among adolescents. Methods For the nine-month School in Motion intervention study (ScIM), we cluster-randomized 30 Norwegian secondary schools (N = 2084, mean age [SD] = 14 [0.3] years) to one of three study arms. The physically active learning (PAL) intervention included 30 min physically active learning, 30 min PA and a 60 min physical education (PE) lesson per week. The Don’t worry-Be happy (DWBH) intervention included a 60 min PA lesson and a 60 min PE lesson per week, both tailored to promote friendships and wellbeing. Both intervention arms were designed to engage the adolescents in 120 min of PA per week in addition to recess and mandatory PE lessons. The control group continued as per usual, including the standard amount of mandatory PE. PA (main outcome) was assessed by accelerometers, CRF and muscle strength (secondary outcomes) were assessed by an intermittent running test and selected tests from the Eurofit test battery. Results Daily PA and time spent in moderate- to vigorous-intensity PA (MVPA) decreased in all groups throughout the intervention. The mean difference in PA level and MVPA for participants in the PAL-intervention arm was 34.7 cpm (95% CI: 4.1, 65.3) and 4.7 min/day (95% CI: 0.6, 8.8) higher, respectively, compared to the control arm. There were no significant intervention effects on daily PA level, MVPA or time spent sedentary for adolescents in the DWBH-intervention arm. Adolescents in the PAL-intervention arm increased distance covered in the running test compared to controls (19.8 m, 95% CI: 10.4, 29.1), whilst a negative intervention effect was observed among adolescents in the DWBH-intervention arm (− 11.6 m, 95% CI: − 22.0, − 1.1). Conclusion The PAL-intervention resulted in a significantly smaller decrease in daily PA level, time spent in MVPA, and increased CRF compared to controls. Our results indicate that a teacher-led intervention, including three unique intervention components, is effective in curbing the decline in PA observed across our cohort and improving CRF. Trial registration ClinicalTrials.gov ID nr: NCT03817047. Registered 01/25/2019 ‘retrospectively registered’.

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Anterior-Lateral Versus Anterior-Posterior Electrode Position for Cardioverting Atrial Fibrillation

Circulation ◽

10.1161/circulationaha.121.056301 ◽

2021 ◽

Author(s):

Anders Sjørslev Schmidt ◽

Kasper Glerup Lauridsen ◽

Dorthe Svenstrup Møller ◽

Per Dahl Christensen ◽

Karen Kaae Dodt ◽

...

Keyword(s):

Atrial Fibrillation ◽

Confidence Interval ◽

Sinus Rhythm ◽

Primary Outcome ◽

Risk Difference ◽

Electrode Position ◽

Percentage Points ◽

Safety Outcomes ◽

Anterior Posterior ◽

Posterior Electrode

Background: Smaller randomized studies have reported conflicting results regarding the optimal electrode position for cardioverting atrial fibrillation. However, anterior-posterior electrode position is widely used as a standard and believed to be superior to anterior-lateral electrode position. Therefore, we aimed to compare anterior-lateral and anterior-posterior electrode position for cardioverting atrial fibrillation in a multicenter randomized trial. Methods: In this multicenter, investigator-initiated, open-label trial, we randomly assigned patients with atrial fibrillation scheduled for elective cardioversion to anterior-lateral or anterior-posterior electrode position. The primary outcome was the proportion of patients in sinus rhythm after the first shock. The secondary outcome was the proportion of patients in sinus rhythm after up to four shocks escalating to maximum energy. Safety outcomes were any cases of arrhythmia during or after cardioversion, skin redness, and patient-reported peri-procedural pain. Results: We randomized 468 patients. The primary outcome occurred in 126 patients (54%) assigned to anterior-lateral electrode position and in 77 patients (33%) assigned to anterior-posterior electrode position, a risk difference of 22 percentage-points, 95%-confidence interval: 13-30, P<0.001. The number of patients in sinus rhythm after the final cardioversion shock was 216 patients (93%) assigned to anterior−lateral electrode position and 200 patients (85%) assigned to anterior-posterior electrode position, a risk difference of 7 percentage−points, 95%−confidence interval: 2−12. There were no significant differences between groups in any safety outcomes. Conclusions: Anterior-lateral electrode position was more effective than anterior-posterior electrode position for biphasic cardioversion of atrial fibrillation. There were no significant differences in any safety outcome.

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