Variation in outcome reporting in endometriosis trials: a systematic review

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• 作者：Martin Hirsch ; BM<sup>asup><sup> ; sup><sup>m.hirsch@qmul.ac.uk" class="auth_mail" title="E-mail the corresponding authorsup> ; James M.N. Duffy ; MBChB<sup>bsup> ; Jennie O. Kusznir ; BMedSci<sup>asup> ; Colin J. Davis ; FRCOG<sup>asup> ; Maria N. Plana ; MD<sup>csup><sup> ; sup><sup>dsup> ; Khalid S. Khan ; MRCOG<sup>asup> ; on behalf of the International Collaboration to Harmonize Outcomes ; Measures for EndometriosisDr James M.N. Duffy ; Cindy Farquhar ; Dr Martin Hirsch ; Neil Johnson ; Khalid Khan
• 关键词：core-outcome sets ; endometriosis ; outcome harmonization ; outcome variation
• 刊名：American Journal of Obstetrics and Gynecology
• 出版年：2016
• 出版时间：April 2016
• 年：2016
• 卷：214
• 期：4
• 页码：452-464
• 全文大小：1355 K

文摘

We reviewed the outcomes and outcome measures reported in randomized controlled trials and their relationship with methodological quality, year of publication, commercial funding, and journal impact factor.

sSec_2">Data Sources

spara0015">We searched the following sources: (1) Cochrane Central Register of Controlled Trials, (2) Embase, and (3) MEDLINE from inception to November 2014.

sSec_3">Study Eligibility

spara0020">We included all randomized controlled trials evaluating a surgical intervention with or without a medical adjuvant therapy for the treatment of endometriosis symptoms.

sSec_4">Study Design

spara0025">Two authors independently selected trials, assessed methodological quality (Jadad score; range, 1-5), outcome reporting quality (Management of Otitis Media with Effusion in Cleft Palate criteria; range, 1-6), year of publication, impact factor in the year of publication, and commercial funding (yes or no). Univariate and bivariate analyses were performed using Spearman Rh and Mann-Whitney U tests. We used a multivariate linear regression model to assess relationship associations between outcome reporting quality and other variables.

sSec_5">Results

spara0030">There were 54 randomized controlled trials (5427 participants), which reported 164 outcomes and 113 outcome measures. The 3 most commonly reported primary outcomes were dysmenorrhea (10 outcome measures; 23 trials), dyspareunia (11 outcome measures; 21 trials), and pregnancy (3 outcome measures; 26 trials). The median quality of outcome reporting was 3 (interquartile range 4&ndash;2) and methodological quality 3 (interquartile range 5&ndash;2). Multivariate linear regression demonstrated a relationship between outcome reporting quality with methodological quality (β = 0.325; P = .038) and year of publication (β = 0.067; P = .040). No relationship was demonstrated between outcome reporting quality with journal impact factor (Rho = 0.190; P = .212) or commercial funding (P = .370).

sSec_6">Conclusion

spara0035">Variation in outcome reporting within published endometriosis trials prohibits comparison, combination, and synthesis of data. This limits the usefulness of research to inform clinical practice, enhance patient care, and improve patient outcomes. In the absence of a core outcome set for endometriosis we recommend the use of the 3 most common pain (dysmenorrhea, dyspareunia, and pelvic pain) and subfertility (pregnancy, miscarriage, and live birth) outcomes. International consensus among stakeholders is needed to establish a core outcome set for endometriosis trials.