Methodological quality of patient-reported outcome research was low in complementary and alternative medicine in oncology

Efficace, Fabio; Horneber, Markus; Lejeune, S.; Dam, Frits van; Leering, Suzanne; Rottmann, Michael; Aaronson, Neil K.

doi:10.1016/j.jclinepi.2006.03.006

Cited by 41 publications

(20 citation statements)

References 68 publications

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“…5,6 The dangers of using surrogate outcomes are well documented. They may have little or no association with their patient-important correlates, leading to the approval and use of interventions that lack efficacy.…”

Section: Discussionmentioning

confidence: 99%

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Are outcomes reported in surgical randomized trials patient-important? A systematic review and meta-analysis

Adie

Harris

Naylor

et al. 2017

CJS

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Background: The dangers of using surrogate outcomes are well documented. They may have little or no association with their patient-important correlates, leading to the approval and use of interventions that lack efficacy. We sought to assess whether primary outcomes in surgical randomized controlled trials (RCTs) are more likely to be patientimportant outcomes than surrogate or laboratory-based outcomes. Methods:We reviewed RCTs assessing an operative intervention published in 2008 and 2009 and indexed in MEDLINE, EMBASE or the Cochrane Central Register of Controlled Trials. After a pilot of the selection criteria, 1 reviewer selected trials and another reviewer checked the selection. We extracted information on outcome characteristics (patient-important, surrogate, or laboratory-based outcome) and whether they were primary or secondary outcomes. We calculated odds ratios (OR) and pooled in random-effects meta-analysis to obtain an overall estimate of the association between patient importance and primary outcome specification. Results:In 350 included RCTs, a total of 8258 outcomes were reported (median 18 per trial. The mean proportion (per trial) of patient-important outcomes was 60%, and 66% of trials specified a patient-important primary outcome. The most commonly reported patientimportant primary outcomes were morbid events (41%), intervention outcomes (11%), function (11%) and pain (9%). Surrogate and laboratory-based primary outcomes were reported in 33% and 8% of trials, respectively. Patient-important outcomes were not associated with primary outcome status (OR 0.82, 95% confidence interval 0.63-1.1, I 2 = 21%). Conclusion:A substantial proportion of surgical RCTs specify primary outcomes that are not patient-important. Authors, journals and trial funders should insist that patientimportant outcomes are the focus of study. Résultats : Un total de 8258 résultats ont été signalés dans les 350 essais cliniques randomisés inclus (pour une médiane de 18 par essai). La proportion moyenne (par essai) de résultats importants pour le patient était de 60 %, et 66 % des essais précisaient un résul-tat primaire important pour le patient. Les résultats primaires importants pour le patient les plus couramment signalés étaient les événements morbides (41 %), les résultats liés à une intervention (11 %), le fonctionnement (11 %) et la douleur (9 %). Des résultats primaires de substitution ou de laboratoire ont été signalés dans 33 % et 8 % des essais, respectivement. Les résultats importants pour le patient n'étaient pas associés à la situation du résultat primaire (RC 0,82, intervalle de confiance de 95 %, 0,63-1,1, I 2 = 21 %). Contexte Conclusion :Un nombre important d'essais cliniques randomisés en chirurgie précisent des résultats primaires qui ne sont pas importants pour le patient. Les auteurs, les revues et les organismes de financement des essais devraient insister pour que les résultats importants pour le patient soient l'objet principal de l'étude. 1,2 Other patientimportant outcomes, such as death and morbi...

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Section: Discussionmentioning

confidence: 99%

“…3 In diabetes trials, only 18% of primary outcomes were patient-important, 4 and other specialties had similarly low rates after empirical reviews. 5,6 The dangers of using surrogate outcomes are well documented. They may have little or no association with their patient-important correlates, leading to the approval and use of interventions that lack efficacy.…”

mentioning

confidence: 99%

Are outcomes reported in surgical randomized trials patient-important? A systematic review and meta-analysis

Adie

Harris

Naylor

et al. 2017

CJS

View full text Add to dashboard Cite

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“…Cette donnée est retrouvée dans la littérature internationale où environ deux tiers des patients ne font pas état de l'utilisation de CAM à leur thérapeute [6, 11,16].…”

Section: Discussionunclassified

Utilisation des médecines complémentaires chez des patientes tunisiennes atteintes de cancer: enquête réalisée auprès de 150 patientes

et al. 2009

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“…In addition, some CAM methods have subjected to costbenefit analyses or reviewed for the strength of their methodology [9][10][11].…”

Section: Introductionmentioning

confidence: 99%

Improving quality of life using compound mind-body therapies: evaluation of a course intervention with body movement and breath therapy, guided imagery, chakra experiencing and mindfulness meditation

2008

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Methodological quality of patient-reported outcome research was low in complementary and alternative medicine in oncology

Cited by 41 publications

References 68 publications

Are outcomes reported in surgical randomized trials patient-important? A systematic review and meta-analysis

Are outcomes reported in surgical randomized trials patient-important? A systematic review and meta-analysis

Utilisation des médecines complémentaires chez des patientes tunisiennes atteintes de cancer: enquête réalisée auprès de 150 patientes

Improving quality of life using compound mind-body therapies: evaluation of a course intervention with body movement and breath therapy, guided imagery, chakra experiencing and mindfulness meditation

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