Letter to the Editor
The thin line between non-inferiority clinical trials and type II errors
La delgada línea de ensayos clínicos de no inferioridad y el error tipo II
Luis Enrique Chaparroa,
, Laura Girón-Arangob
Corresponding author
lechaparro@gmail.com
Corresponding author at: 12th Floor, 123 Edward Street, Toronto, Ontario M5G 1E2, Canada.
Corresponding author at: 12th Floor, 123 Edward Street, Toronto, Ontario M5G 1E2, Canada.
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In a purely academic spirit, we would like to underscore a few ideas.<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">1.</span><p id="par0010" class="elsevierStylePara elsevierViewall">Ideally, an RCT requires one person to administer the medication and a second one to assess the outcomes. If this is not possible, the effect of the intervention may be over-estimated (around 40%).<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">3</span></a> However, we empathize with those authors that sacrifice their own resources for the sake of science.<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">4</span></a></p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">2.</span><p id="par0015" class="elsevierStylePara elsevierViewall">The primary outcome variable – sample size calculation – should be explicit. This is a usual issue with RCT.<a class="elsevierStyleCrossRef" href="#bib0060"><span class="elsevierStyleSup">5</span></a></p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">3.</span><p id="par0020" class="elsevierStylePara elsevierViewall">When designing the essay: were the authors looking for the advantages of combination therapy versus the use of midazolam or on the contrary, were they looking for equivalence among interventions? – equivalence trials require hundreds and some times thousands of participants to avoid type II errors (assuming no difference when in fact there was a difference).<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">6</span></a></p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">4.</span><p id="par0025" class="elsevierStylePara elsevierViewall">We don’t want to look heartless, but would it be unreasonable to consider a placebo group (no sedation) or background music<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">7</span></a> for patients who just need a spinal injection?… sedation enhances the tolerance to the procedure but may deteriorate patient's cooperation for positioning.</p></li></ul></p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Funding</span><p id="par0030" class="elsevierStylePara elsevierViewall">The authors did not receive sponsorship to undertake this article.</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Conflicts of interest</span><p id="par0035" class="elsevierStylePara elsevierViewall">The authors have no conflicts of interest to declare.</p></span></span>" "textoCompletoSecciones" => array:1 [ "secciones" => array:3 [ 0 => array:2 [ "identificador" => "sec0005" "titulo" => "Funding" ] 1 => array:2 [ "identificador" => "sec0010" "titulo" => "Conflicts of interest" ] 2 => array:1 [ "titulo" => "References" ] ] ] "pdfFichero" => "main.pdf" "tienePdf" => true "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Chaparro LE, Girón-Arango L. La delgada línea de ensayos clínicos de no inferioridad y el error tipo II. Rev Colomb Anestesiol. 2016;44:73.</p>" ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0005" "bibliografiaReferencia" => array:7 [ 0 => array:3 [ "identificador" => "bib0040" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Recomendaciones para la sedación y la analgesia por médicos no anestesiólogos y odontólogos de pacientes mayores de 12 años" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "P. Ibarra" 1 => "M. Galindo" 2 => "A. Molano" 3 => "C. Niño" 4 => "A. Rubiano" 5 => "P. Echeverry" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:5 [ "tituloSerie" => "Rev Colomb Anestesiol" "fecha" => "2012" "volumen" => "40" "paginaInicial" => "67" "paginaFinal" => "74" ] ] ] ] ] ] 1 => array:3 [ "identificador" => "bib0045" "etiqueta" => "2" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Comparación de 3 pautas de sedación para pacientes sometidos a anestesia subaracnoidea. Ensayo clínico aleatorizado, simple ciego" "autores" => array:1 [ 0 => array:2 [ "etal" => false "autores" => array:5 [ 0 => "F.J. Bermúdez-Guerrero" 1 => "D. Gómez-Camargo" 2 => "R. Palomino-Romero" 3 => "W. Llamas-Bustos" 4 => "E. 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DeGagné" ] ] ] ] ] "host" => array:1 [ 0 => array:1 [ "Revista" => array:6 [ "tituloSerie" => "Anesth Analg" "fecha" => "2001" "volumen" => "93" "paginaInicial" => "912" "paginaFinal" => "916" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/11574356" "web" => "Medline" ] ] ] ] ] ] ] ] ] ] ] ] ] "idiomaDefecto" => "en" "url" => "/22562087/0000004400000001/v1_201601280036/S2256208715000838/v1_201601280036/en/main.assets" "Apartado" => array:4 [ "identificador" => "47685" "tipo" => "SECCION" "en" => array:2 [ "titulo" => "Letters to the Editor" "idiomaDefecto" => true ] "idiomaDefecto" => "en" ] "PDF" => "https://static.elsevier.es/multimedia/22562087/0000004400000001/v1_201601280036/S2256208715000838/v1_201601280036/en/main.pdf?idApp=UINPBA00004N&text.app=https://www.elsevier.es/" "EPUB" => "https://multimedia.elsevier.es/PublicationsMultimediaV1/item/epub/S2256208715000838?idApp=UINPBA00004N" ]
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| 2017 June | 19 | 7 | 26 |
| 2017 May | 20 | 9 | 29 |
| 2017 April | 32 | 11 | 43 |
| 2017 March | 13 | 6 | 19 |
| 2017 February | 4 | 12 | 16 |
| 2017 January | 10 | 7 | 17 |
| 2016 December | 27 | 11 | 38 |
| 2016 November | 20 | 6 | 26 |
| 2016 October | 26 | 9 | 35 |
| 2016 September | 22 | 6 | 28 |
| 2016 August | 25 | 7 | 32 |
| 2016 July | 13 | 7 | 20 |
| 2016 June | 1 | 0 | 1 |
| 2016 May | 2 | 0 | 2 |
| 2016 April | 0 | 18 | 18 |
| 2016 March | 2 | 0 | 2 |
| 2016 February | 2 | 17 | 19 |
Show all