A new and improved confidence interval for the Mantel–Haenszel risk difference

Klingenberg, Bernhard

doi:10.1002/sim.6122

Cited by 32 publications

(36 citation statements)

References 27 publications

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“…The study hypothesis will be tested by a one-sided 97.5% confidence interval for the effect of study group (absolute risk difference). This confidence interval will be adjusted for effects of type of appendicitis and age (as a single categorical covariate: < 16 years old/non-perforated, < 16 years old/perforated, ≥16 years old/non-perforated, ≥16 years old/perforated) using the method proposed by Klingenberg [ 41 , 42 ]. Non-inferiority will be established if the upper limit of the confidence interval is lower than 7.5%.…”

Section: Methodsmentioning

confidence: 99%

Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial

Boom

Wijkerslooth

Rosmalen

et al. 2018

Trials

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BackgroundAcute appendicitis is one of the most common indications for emergency surgery. In patients with a complex appendicitis, prolonged antibiotic prophylaxis is recommended after appendectomy. There is no consensus regarding the optimum duration of antibiotics. Guidelines propose 3 to 7 days of treatment, but shorter courses may be as effective in the prevention of infectious complications. At the same time, the global issue of increasing antimicrobial resistance urges for optimization of antibiotic strategies. The aim of this study is to determine whether a short course (48 h) of postoperative antibiotics is non-inferior to current standard practice of 5 days.MethodsPatients of 8 years and older undergoing appendectomy for acute complex appendicitis – defined as a gangrenous and/or perforated appendicitis or appendicitis in presence of an abscess – are eligible for inclusion. Immunocompromised or pregnant patients are excluded, as well as patients with a contraindication to the study antibiotics. In total, 1066 patients will be randomly allocated in a 1:1 ratio to the experimental treatment arm (48 h of postoperative intravenously administered (IV) antibiotics) or the control arm (5 days of postoperative IV antibiotics). After discharge from the hospital, patients participate in a productivity-cost-questionnaire at 4 weeks and a standardized telephone follow-up at 90 days after appendectomy. The primary outcome is a composite endpoint of infectious complications, including intra-abdominal abscess (IAA) and surgical site infection (SSI), and mortality within 90 days after appendectomy. Secondary outcomes include IAA, SSI, restart of antibiotics, length of hospital stay (LOS), reoperation, percutaneous drainage, readmission rate, and cost-effectiveness. The non-inferiority margin for the difference in the primary endpoint rate is set at 7.5% (one-sided test at ɑ 0.025). Both per-protocol and intention-to-treat analyses will be performed.DiscussionThis trial will provide evidence on whether 48 h of postoperative antibiotics is non-inferior to a standard course of 5 days of antibiotics. If non-inferiority is established, longer intravenous administration following appendectomy for complex appendicitis can be abandoned, and guidelines need to be adjusted accordingly.Trial registrationDutch Trial Register, NTR6128. Registered on 20 December 2016.Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2629-0) contains supplementary material, which is available to authorized users.

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Section: Methodsmentioning

confidence: 99%

Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial

Boom

Wijkerslooth

Rosmalen

et al. 2018

Trials

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“…Secondary efficacy end points will be analysed in detail as follows: The proportion of subjects with sedation success between treatments within each age group will be based on the Mantel-Haenszel risk difference, with stratification by centre. 45 A 15% non-inferiority margin at a one-sided alpha level of 0.025 will be used. The aggregate intervals (ie, the total time) (based on the planned assessment points) with COMFORT-B score >22 or <11 during treatment period between treatment groups were analysed using the Mann-Whitney U test.…”

Section: Methodsmentioning

confidence: 99%

“…The proportion of subjects with sedation success between treatments within each age group will be based on the Mantel-Haenszel risk difference, with stratification by centre. 45 A 15% non-inferiority margin at a one-sided alpha level of 0.025 will be used.…”

Section: Methodsmentioning

confidence: 99%

The CLOSED trial; CLOnidine compared with midazolam for SEDation of paediatric patients in the intensive care unit: study protocol for a multicentre randomised controlled trial

et al. 2017

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IntroductionSedation is an essential part of paediatric critical care. Midazolam, often in combination with opioids, is the current gold standard drug. However, as it is a far-from-ideal agent, clonidine is increasingly being used in children. This drug is prescribed off-label for this indication, as many drugs in paediatrics are. Therefore, the CLOSED trial aims to provide data on the pharmacokinetics, safety and efficacy of clonidine for the sedation of mechanically ventilated patients in order to obtain a paediatric-use marketing authorisation.Methods and analysisThe CLOSED study is a multicentre, double-blind, randomised, active-controlled non-inferiority trial with a 1:1 randomisation between clonidine and midazolam. Both treatment groups are stratified according to age in three groups with the same size: <28 days (n=100), 28 days to <2 years (n=100) and 2–18 years (n=100). The primary end point is defined as the occurrence of sedation failure within the study period. Secondary end points include a pharmacokinetic/pharmacodynamic relationship, pharmacogenetics, occurrence of delirium and withdrawal syndrome, opioid consumption and neurodevelopment in the neonatal age group. Logistic regression will be used for the primary end point, appropriate statistics will be used for the secondary end points.EthicsWritten informed consent will be obtained from the parents/caregivers. Verbal or deferred consent will be used in the sites where national legislation allows. The study has institutional review board approval at recruiting sites. The results will be published in a peer-reviewed journal and shared with the worldwide medical community.Trial RegistrationEudraCT: 2014-003582-24; Clinicaltrials.gov: NCT02509273; pre-results.

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“…The two treatment groups will be compared using a two-sided χ 2 test for independent samples regarding the incidence of any postoperative complication. The results will be presented as absolute risk reduction based on the Mantel-Haenszel risk differences and its improved confidence interval estimate [25]. Sub-groups analyses and adjustments will be included for risk groups according to ASA status, preoperatively existing vs. intraoperatively acquired hypalbuminemia, and varying surgical interventions.…”

Section: Methodsmentioning

confidence: 99%

Substitution of perioperative albumin deficiency disorders (SuperAdd) in adults undergoing vascular, abdominal, trauma, or orthopedic surgery: protocol for a randomized controlled trial

Schaller

Fuest

Ulm

et al. 2020

Trials

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Background: Hypalbuminemia is associated with numerous postoperative complications, so a perioperative albumin substitution is often considered. The objective of SuperAdd is to investigate whether substitution of human albumin, aiming to maintain a serum concentration > 30 g/l, can reduce postoperative complications in normovolemic surgical patients in comparison with standard care. Methods/design: SuperAdd is a single-center, prospective, randomized, outcome-assessor blinded, patient blinded controlled trial. The primary outcome is the frequency of postoperative complications identified using the Postoperative Morbidity Survey graded ≥ 2 according to the Clavien-Dindo Score. Adult patients at risk to develop hypalbuminemia, i.e., ASA III or IV or high-risk surgery, are recruited after written informed consent was obtained. The albumin concentration is assessed before the induction of anesthesia and every 3 h until admission to the postanesthesia care unit. If albumin concentrations drop below 30 g/l, patients are randomly allocated to the control or the treatment group. The study intervention is a goal-directed human albumin substitution aimed at a concentration > 30 g/l during surgery and postanesthesia care unit stay. The patients in the control group are treated according to standard clinical care. Postoperative visits are to be performed on days 1, 3, 5, 8, and 15, as well as by telephone 6 months after surgery. Discussion: SuperAdd is the first clinical trial in a surgical population investigating the effect of a goal-directed albumin substitution aiming at a serum level > 30 g/l. The nonrestrictive selection of patients guarantees that the patients without albumin screening will most likely not develop hypalbuminemia, thus ensuring generalizability of the study results.

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A new and improved confidence interval for the Mantel–Haenszel risk difference

Cited by 32 publications

References 27 publications

Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial

Two versus five days of antibiotics after appendectomy for complex acute appendicitis (APPIC): study protocol for a randomized controlled trial

The CLOSED trial; CLOnidine compared with midazolam for SEDation of paediatric patients in the intensive care unit: study protocol for a multicentre randomised controlled trial

Substitution of perioperative albumin deficiency disorders (SuperAdd) in adults undergoing vascular, abdominal, trauma, or orthopedic surgery: protocol for a randomized controlled trial

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