Reporting of Noninferiority and Equivalence Randomized Trials

Piaggio, Gilda; Elbourne, Diana; Pocock, Stuart J.; Evans, Stephen; Altman, Douglas G.; Group, for the CONSORT

doi:10.1001/jama.2012.87802

Cited by 1,374 publications

(967 citation statements)

References 98 publications

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“…The protocol was approved by the regional ethics committee. Sample size calculation was conducted using the equivalence criterion [22]. Sixty hips in each group were required to show that the mean Harris hip score was the same in both groups with a power of 95% assuming a common SD of 15 and that a difference in means of less than 10 points was unimportant using a two-sided alpha set to 0.05.…”

Section: Methodsmentioning

confidence: 99%

“…To minimize the risk of falsely concluding equivalence, all analyses were conducted on a per-protocol basis; that is, participants not operated on according to the allocated treatment were not included in the analysis [22]. The patients representing protocol deviations at the beginning of the trial were not included in the previous publication [5] (Fig.…”

Section: Methodsmentioning

confidence: 99%

“…Therefore, we were not able to include an intention-to-treat analysis. For the equivalence analysis, we used the twosided confidence interval approach [22]. We used the twotailed Fisher's exact test for dichotomous variables and t-tests for numerical variables.…”

Section: Methodsmentioning

confidence: 99%

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Cemented versus Uncemented Hemiarthroplasty for Displaced Femoral Neck Fractures: 5-year Followup of a Randomized Trial

Langslet

Frihagen

Opland

et al. 2014

Clinical Orthopaedics &Amp; Related Research

193

162

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Background Displaced femoral neck fractures usually are treated with hemiarthroplasty. However, the degree to which the design of the implant used (cemented or uncemented) affects the outcome is not known and may be therapeutically important. Questions/purposes In this randomized controlled trial, we sought to compare cemented with cementless fixation in bipolar hemiarthroplasties at 5 years in terms of (1) Harris hip scores; (2) femoral fractures; (3) overall health outcomes using the Barthel Index and EQ-5D scores; and (4) complications, reoperations, and mortality since our earlier report on this cohort at 1-year followup. Methods We present followup at a median of 5 years after surgery (range, 56-65 months) from a randomized trial comparing a cemented hemiarthroplasty (112 hips) with an uncemented, hydroxyapatite-coated hemiarthroplasty (108 hips), both with a bipolar head. Results were previously reported at 1-year followup. Harris hip scores, Barthel Index, and EQ-5D scores were assessed by one research nurse and one orthopaedic surgeon. Complications and reoperations were determined by chart review and radiographs examined by three orthopaedic surgeons. Sixty patients (56%) had died in the cemented group and 63 (60%) in the uncemented group. Respectively, three and two patients (2.7% and 1.9%) were completely lost to followup. Results Harris hip scores at 5 years were higher in the uncemented group than in the cemented group (86.2 versus 76.3; mean difference 9.9; 95% confidence interval [CI], 1.9-17.9). The prevalence of postoperative periprosthetic femoral fractures was 7.4% in the uncemented group and 0.9% in the cemented group (hazard ratio [HR], 9.3; 95% CI, 1.16-74.5). Barthel Index and EQ-5D scores were not different between the groups. Between 1 and 5 years, we found no additional infections or dislocations. The mortality rate was not different between the groups (HR, 1.2; 95% CI, 0.82-1.7).

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

See 1 more Smart Citation

Cemented versus Uncemented Hemiarthroplasty for Displaced Femoral Neck Fractures: 5-year Followup of a Randomized Trial

Langslet

Frihagen

Opland

et al. 2014

Clinical Orthopaedics &Amp; Related Research

193

162

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“…We hypothesised non‐inferiority between dyad and single practice and used pre‐planned specified boundaries according to current recommendations 25. The study is reported according to the CONSORT statement, as well as the CONSORT extension on equivalence trials 26, 27. Sample size calculations for this trial were based on previously published studies (reported below).…”

Section: Methodsmentioning

confidence: 99%

The effect of dyad versus individual simulation‐based ultrasound training on skills transfer

et al. 2015

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ContextDyad practice may be as effective as individual practice during clinical skills training, improve students’ confidence, and reduce costs of training. However, there is little evidence that dyad training is non‐inferior to single‐student practice in terms of skills transfer.ObjectivesThis study was conducted to compare the effectiveness of simulation‐based ultrasound training in pairs (dyad practice) with that of training alone (single‐student practice) on skills transfer.MethodsIn a non‐inferiority trial, 30 ultrasound novices were randomised to dyad (n = 16) or single‐student (n = 14) practice. All participants completed a 2‐hour training programme on a transvaginal ultrasound simulator. Participants in the dyad group practised together and took turns as the active practitioner, whereas participants in the single group practised alone. Performance improvements were evaluated through pre‐, post‐ and transfer tests. The transfer test involved the assessment of a transvaginal ultrasound scan by one of two clinicians using the Objective Structured Assessment of Ultrasound Skills (OSAUS).ResultsThirty participants completed the simulation‐based training and 24 of these completed the transfer test. Dyad training was found to be non‐inferior to single‐student training: transfer test OSAUS scores were significantly higher than the pre‐specified non‐inferiority margin (delta score 7.8%, 95% confidence interval −3.8–19.6%; p = 0.04). More dyad (71.4%) than single (30.0%) trainees achieved OSAUS scores above a pre‐established pass/fail level in the transfer test (p = 0.05). There were significant differences in performance scores before and after training in both groups (pre‐ versus post‐test, p < 0.01) with large effect sizes (Cohen's d = 3.85) and no significant interactions between training type and performance (p = 0.59). The dyad group demonstrated higher training efficiency in terms of simulator score per number of attempts compared with the single‐student group (p = 0.03).ConclusionDyad practice improves the efficiency of simulation‐based training and is non‐inferior to individual practice in terms of skills transfer.

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“…It involved a comprehensive protocol (titled "Psychiatric Academic Registration Leiden database") which safeguarded the anonymity of patients and participants and ensured proper handling of the data. We followed consolidated standards for reporting randomised controlled equivalence trials (Hopewell et al, 2008;Moher et al, 2010;Piaggio et al, 2012). All participants provided written informed consent before study entry.…”

Section: Methodsmentioning

confidence: 99%

The clinical effectiveness of concise cognitive behavioral therapy with or without pharmacotherapy for depressive and anxiety disorders; a pragmatic randomized controlled equivalence trial in clinical practice

Meuldijk

Carlier

Vliet

et al. 2016

Contemporary Clinical Trials

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. (2016). The clinical effectiveness of concise cognitive behavioral therapy with or without pharmacotherapy for depressive and anxiety disorders; a pragmatic randomized controlled equivalence trial in clinical practice. Contemporary Clinical Trials, 47 131-138. See next page for additional authorsThe clinical effectiveness of concise cognitive behavioral therapy with or without pharmacotherapy for depressive and anxiety disorders; a pragmatic randomized controlled equivalence trial in clinical practice Abstract Background: Depressive and anxiety disorders contribute to a high disease burden. This paper investigates whether concise formats of cognitive behavioral-and/or pharmacotherapy are equivalent with longer standard care in the treatment of depressive and/or anxiety disorders in secondary mental health care. Methods: A pragmatic randomized controlled equivalence trial was conducted at five Dutch outpatient Mental Healthcare Centers (MHCs) of the Regional Mental Health Provider (RMHP) 'Rivierduinen'. Patients (aged 18-65 years) with a mild to moderate anxiety and/or depressive disorder, were randomly allocated to concise or standard care. Data were collected at baseline, 3, 6 and 12 months by Routine Outcome Monitoring (ROM). Primary outcomes were the Brief Symptom Inventory (BSI) and the Web Screening Questionnaire (WSQ). We used Generalized Estimating Equations (GEE) to assess outcomes. Results: Between March 2010 and December 2012, 182 patients, were enrolled (n = 89 standard care; n = 93 concise care). Both intention-to-treat and per-protocol analyses demonstrated equivalence of concise care and standard care at all time points. Severity of illness reduced, and both treatments improved patient's general health status and subdomains of quality of life. Moreover, in concise care, the beneficial effects started earlier. Discussion: Concise care has the potential to be a feasible and promising alternative to longer standard secondary mental health care in the treatment of outpatients with a mild to moderate depressive and/or anxiety disorder. For future research, we recommend adhering more strictly to the concise treatment protocols to further explore the beneficial effects of the concise treatment. Moreover, in concise care, the beneficial effects started earlier.

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Reporting of Noninferiority and Equivalence Randomized Trials

Cited by 1,374 publications

References 98 publications

Cemented versus Uncemented Hemiarthroplasty for Displaced Femoral Neck Fractures: 5-year Followup of a Randomized Trial

Cemented versus Uncemented Hemiarthroplasty for Displaced Femoral Neck Fractures: 5-year Followup of a Randomized Trial

The effect of dyad versus individual simulation‐based ultrasound training on skills transfer

The clinical effectiveness of concise cognitive behavioral therapy with or without pharmacotherapy for depressive and anxiety disorders; a pragmatic randomized controlled equivalence trial in clinical practice

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