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\begin{document}

\title{Re: Laparoscopic ablation or excision with helium thermal coagulator
versus electrodiathermy for the treatment of mild-to-moderate
endometriosis: randomised controlled trial. (First comment on
BJOG-19-1874.R2)}



\author[1]{Martin Hirsch}%
\author[2]{James Duffy}%
\author[3]{Cindy Farquhar}%
\affil[1]{University College London}%
\affil[2]{Nuffield Health}%
\affil[3]{The University of Auckland Faculty of Medical and Health Sciences}%


\vspace{-1em}



  
  \date{June 13, 2024}


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Sir,

We read with great interest the recent study by Misra \emph{et
al.}evaluating different surgical interventions for the treatment of
pain associated with endometriosis.\textsuperscript{1} We understand the
importance of this research to inform our clinical practice and extend
our gratitude to the researchers, the women who participated in the
study, and the research funder.

\emph{BJOG: An International Journal of Obstetrics and Gynaecology} has
been at the forefront of reducing research waste by implementing several
important interventions including the requirement to prospectively
register randomised trials, implementing the Consolidated Standards of
Reporting Trials (CONSORT) statement, and mandating the reporting of
core outcome sets.\textsuperscript{2}

Reflecting upon this recent study presents an opportunity to consider
the impact of implementing such initiatives on selective outcome
reporting. The authors prospectively registered their trial
(ISRCTN50928834) and reported their pre-specified primary outcome as
pelvic pain. This differs from the primary outcome reported in the final
publication. A secondary outcome, dyspareunia, reported in the final
publication, was not prospectively registered. The CONSORT statement
commits researchers to report all prespecified primary and secondary
outcomes. When new outcomes are added this should be made clear in the
final publication and a comprehensive explanation provided. It would be
useful for the authors to clarify the discrepancies between the
prospective registry record and the published trial report.

Core outcomes aim to address the challenges of poorly selected,
collected, and reporting outcomes, including tackling outcome reporting
bias.\textsuperscript{3} We are grateful to the authors for
acknowledging the development of a core outcome set for endometriosis
research within their study report. The core outcome set for
endometriosis has recently been published and was developed using formal
consensus methods involving 116 healthcare professionals, 32
researchers, and 206 women with endometriosis from 29
countries.\textsuperscript{4} The core outcomes include overall pain,
improvement in most troublesome symptom, quality of life, adverse
events, and patient satisfaction with treatment. It would be useful for
the authors to clarify if the core outcomes had been collected as part
of the trial and report available data.

Over eighty speciality journals, including the Cochrane Gynaecology and
Fertility Group, have committed to supporting the development,
dissemination, and implementation of the core outcome set for
endometriosis. The collaboration who have developed the core outcome set
for endometriosis are now assisting with implementation and are
systematically examining published endometriosis trials. Where
inconsistencies between the trial registry record and the outcomes
reported in the published trial report are identified or when the core
outcome set has not been fully reported we are writing to the authors
seeking clarification. Our progress can be followed at
https://twitter.com/EndoOutcomes where we will be posting the
prospective registry record, final publication, and response to this
letter.

Martin HIRSCH\textsuperscript{a}, James M. N.
DUFFY\textsuperscript{a,b}, , Cindy M. FARQUHAR\textsuperscript{c}

On behalf of \textbf{endo:outcomes} an international collaboration
harmonising outcomes and outcome measures for endometriosis research

\textsuperscript{a} Institute for Women's Health, University College
London, London, United Kingdom.

\textsuperscript{b} King's Fertility, The Fetal Medicine Research
Institute, London, United Kingdom.

\textsuperscript{c} Cochrane Gynaecology and Fertility Group, Department
of Obstetrics and Gynaecology, University of Auckland, Auckland, New
Zealand

\textbf{References}

1. Misra G, Sim J, El-Gizawy Z, Watts K, Jerreat S, Coia T, et al.
Laparoscopic ablation or excision with helium thermal coagulator versus
electrodiathermy for the treatment of mild-to-moderate endometriosis:
randomized controlled trial. BJOG: An International Journal of
Obstetrics \& Gynaecology.

2. Duffy J, Bhattacharya S, Herman M, Mol B, Vail A, Wilkinson J, et al.
Reducing research waste in benign gynaecology and fertility research.
BJOG: An International Journal of Obstetrics \& Gynaecology.
2017;124(3):366-9.

3. Hirsch M, Duffy JMN, Kusznir JO, Davis CJ, Plana MN, Khan KS, et al.
Variation in outcome reporting in endometriosis trials: a systematic
review. American Journal of Obstetrics \& Gynecology.
2016;214(4):452-64.

4. Duffy J, Hirsch M, Vercoe M, Abbott J, Barker C, Collura B, et al. A
core outcome set for future endometriosis research: an international
consensus development study. BJOG: An International Journal of
Obstetrics \& Gynaecology.

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