\documentclass[10pt]{article}

\usepackage{fullpage}
\usepackage{setspace}
\usepackage{parskip}
\usepackage{titlesec}
\usepackage[section]{placeins}
\usepackage{xcolor}
\usepackage{breakcites}
\usepackage{lineno}
\usepackage{hyphenat}





\PassOptionsToPackage{hyphens}{url}
\usepackage[colorlinks = true,
            linkcolor = blue,
            urlcolor  = blue,
            citecolor = blue,
            anchorcolor = blue]{hyperref}
\usepackage{etoolbox}
\makeatletter
\patchcmd\@combinedblfloats{\box\@outputbox}{\unvbox\@outputbox}{}{%
  \errmessage{\noexpand\@combinedblfloats could not be patched}%
}%
\makeatother


\usepackage{natbib}




\renewenvironment{abstract}
  {{\bfseries\noindent{\abstractname}\par\nobreak}\footnotesize}
  {\bigskip}

\titlespacing{\section}{0pt}{*3}{*1}
\titlespacing{\subsection}{0pt}{*2}{*0.5}
\titlespacing{\subsubsection}{0pt}{*1.5}{0pt}


\usepackage{authblk}


\usepackage{graphicx}
\usepackage[space]{grffile}
\usepackage{latexsym}
\usepackage{textcomp}
\usepackage{longtable}
\usepackage{tabulary}
\usepackage{booktabs,array,multirow}
\usepackage{amsfonts,amsmath,amssymb}
\providecommand\citet{\cite}
\providecommand\citep{\cite}
\providecommand\citealt{\cite}
% You can conditionalize code for latexml or normal latex using this.
\newif\iflatexml\latexmlfalse
\providecommand{\tightlist}{\setlength{\itemsep}{0pt}\setlength{\parskip}{0pt}}%

\AtBeginDocument{\DeclareGraphicsExtensions{.pdf,.PDF,.eps,.EPS,.png,.PNG,.tif,.TIF,.jpg,.JPG,.jpeg,.JPEG}}

\usepackage[utf8]{inputenc}
\usepackage[ngerman,english]{babel}



\usepackage{float}








\begin{document}

\title{Improvement was needed in the standards of development for obstetrics
and gynecology core outcome sets}



\author[1]{Jiyuan Shi}%
\author[1]{Ya Gao}%
\author[1]{Mingming Niu}%
\author[1]{Yamin Chen}%
\author[1]{Meili Yan}%
\author[1]{Ziwei Song}%
\author[2]{Yuanyuan Li}%
\author[1]{Ming Liu}%
\author[3]{Junhua Zhang}%
\author[1]{Jinhui Tian}%
\affil[1]{Affiliation not available}%
\affil[2]{Lanzhou University}%
\affil[3]{Tianjin University of Traditional Chinese Medicine}%


\vspace{-1em}



  
  \date{May 24, 2024}


\begingroup
\let\center\flushleft
\let\endcenter\endflushleft
\maketitle
\endgroup





\selectlanguage{english}
\begin{abstract}
Abstract Objectives This study aimed to investigate the characteristics
of obstetrics and gynecology (OG) core outcome sets (COSs) and assess
the report and design standards of OG COSs, and exploring how to improve
baseline standards for obstetrics and gynecology COSs development. Study
Design and Setting We conducted a comprehensive search of COMET database
on December 20, 2019. Two reviewers independently evaluated whether the
OG COS met the reporting requirement as stipulated in the Core Outcome
Set-STAndards for Reporting (COS-STAR) statement checklist and the
minimum design recommendations using the Core Outcome Set-STAndards for
Development (COS-STAD) checklist. Results Forty-four OG COSs focused on
26 topics. None met all the 25 standards of COS-STAR statement
representing 18 items considered essential for transparent and complete
reporting in all COS studies (range: 6.0-24.0, median: 14.0 ). The
compliance rates for the 16 standards of methods and result sections
ranged from 27.3\% - 68.2\%. Total COS-STAR compliance items of OG COSs
with the prior protocol was significantly higher than without prior
protocol (MD= 3.846, 95\% CI: 0.835 - 6.858, P= 0.012). None of the OG
COSs met all the 12 criteria of COS-STAD minimum standards (range:
3.0-11.0, median: 5.0). The compliance rates for all three standards of
stakeholders involved and all four standards of the consensus process
were lower than 60\%. Conclusion Methodological and reporting standards
of OG COSs should be further improved.%
\end{abstract}%



\sloppy


\textbf{Improvement was needed in the standards of development for
obstetrics and gynecology core outcome sets}

Jiyuan Shi\textsuperscript{a,1}, Ya Gao\textsuperscript{b,1}, MingMing
Niu\textsuperscript{a}, Yamin Chen\textsuperscript{a}, Meili
Yan\textsuperscript{a}, Ziwei Song\textsuperscript{a}, Yuanyuan
Li\textsuperscript{a}, Ming Liu\textsuperscript{b}, Jinhui
Tian\textsuperscript{a,b,}*, Junhua Zhang\textsuperscript{c,}*

\begin{enumerate}
\tightlist
\item
  Evidence-Based Nursing Centre, School of nursing, Lanzhou University,
  Lanzhou City 730000, Gansu Province, China.
\item
  School of Basic Medical Sciences, Lanzhou University, Lanzhou City,
  730000, Gansu Province, China.
\item
  Evidence-Based Medicine Center, Tianjin University of Traditional
  Chinese Medicine, Tianjin, China.
\end{enumerate}

\textsuperscript{\textbf{1}}\textbf{Jiyuan Shi and Ya Gao did equal to
this work}

Correspondence to: Jinhui Tian, Evidence-Based Medicine Centre, School
of Basic Medical Sciences, Lanzhou University, No.199, Donggang West
Road, Lanzhou City, 730000, Gansu Province, China. (
Email:tianjh996@163.com).

Correspondence to: Junhua Zhang, Evidence-Based Medicine Center, Tianjin
University of Traditional Chinese Medicine, No. 312 Anshanxi Street,
Nankai District, Tianjin 300193, China.(
Email:\emph{zjhtcm@foxmail.com}.)

\textbf{Word count:}

Abstract: 227 words

Manuscript: 3719 words

\textbf{Running title}

Obstetrics and gynecology core outcome sets

\textbf{Abstract}

\textbf{Objectives}

This study aimed to investigate the characteristics of obstetrics and
gynecology (OG) core outcome sets (COSs) and assess the report and
design standards of OG COSs, and exploring how to improve baseline
standards for obstetrics and gynecology COSs development.

\textbf{Study Design and Setting}

We conducted a comprehensive search of COMET database on December 20,
2019. Two reviewers independently evaluated whether the OG COS met the
reporting requirement as stipulated in the Core Outcome Set-STAndards
for Reporting (COS-STAR) statement checklist and the minimum design
recommendations using the Core Outcome Set-STAndards for Development
(COS-STAD) checklist.

\textbf{Results}

Forty-four OG COSs focused on 26 topics. None met all the 25 standards
of COS-STAR statement representing 18 items considered essential for
transparent and complete reporting in all COS studies (range: 6.0-24.0,
median: 14.0 ). The compliance rates for the 16 standards of methods and
result sections ranged from 27.3\% - 68.2\%. Total COS-STAR compliance
items of OG COSs with the prior protocol was significantly higher than
without prior protocol (MD= 3.846, 95\% CI: 0.835 - 6.858, P= 0.012).
None of the OG COSs met all the 12 criteria of COS-STAD minimum
standards (range: 3.0-11.0, median: 5.0). The compliance rates for all
three standards of stakeholders involved and all four standards of the
consensus process were lower than 60\%.

\textbf{Conclusion}

Methodological and reporting standards of OG COSs should be further
improved.

\textbf{Registration number :} 1581
(http://www.comet-initiative.org/Studies/Details/1581).

\textbf{Keywords:} Core outcome set; Obstetrics; Gynecology; Research
methodology; COS; Report methodology

\textbf{Tweetable abstract:} Methodological and reporting standards of
obstetrics and gynecology core outcome sets COSs should be further
improved.

\textbf{Introduction}

Selecting outcomes that adequately reflect relevant issues to patients
and health care professionals is essential when designing clinical
trials to compare the effects of different interventions
directly.\textsuperscript{1, 2} Core outcome sets (COSs) represent the
minimum important outcomes that should be measured and reported in all
research studies for a specific condition.\textsuperscript{1} The use of
high-quality COSs in clinical trials has the following benefits;
improves comparability between similar trials, reduces selective
reporting of results, increases the relevance of trial and systematic
review results,\textsuperscript{3} and enhances the quality of evidence
used in health care decision-making ultimately translates to improved
health care for patients.\textsuperscript{4} COSs are increasingly
recognized as important for the design, implementation, and reporting of
randomized trials, systematic reviews, and other forms of
research.\textsuperscript{5-7}

The rapid increase in the number of COSs covering a wide range of
different health-related areas has seen the standards of COSs definition
vary considerably.\textsuperscript{6, 8-13} Previous studies have
suggested that a high-quality set of COSs should include a comprehensive
scoping process and a consensus process that involves multi-stakeholder
groups.\textsuperscript{14-16} Whether these published COSs undertook a
systematic review of existing outcomes or fully considered the views of
different stakeholder groups on the COSs, remains
unclear.\textsuperscript{17} The Core Outcome SeteSTAndards for
Development (COS-STAD) project aimed to identify those aspects of COSs
development for which minimum standards can be agreed upon and applied
regardless of the consensus method chosen. Recommendations have since
been established to improve the methodological approach for developing
COSs and help users assess the applicability of a particular
COSs.\textsuperscript{15} Additionally, the Core Outcome Set-STAndards
for Reporting (COS-STAR) statement was developed using the recommended
approach for developing medical reporting
guidelines.\textsuperscript{18} The difference between COS-STAD and
COS-STAR is that the former focuses on the principles of design
associated with COSs development, while the latter focuses on the
reporting of COSs development studies. While applying COS-STAD standards
to assess the design quality of cancer COSs, a recent pilot study
revealed that the scoping process and consensus process of cancer COSs
were not optimistic.\textsuperscript{19} Besides, none of the studies
met all the 12 standards representing the 11 minimum standards assessed.
Therefore, it is valuable to explore ways of improving the existing
standards of COSs development.

Obstetrics and gynecology (OG) is a specialty in clinical medicine that
focuses on the physiological and pathological changes of the female
reproductive system, as well as fertility
regulation.\textsuperscript{20-22} Well-developed COSs should ensure
that outcomes in OG trials reflect prioritize relevant issues to both
patients and health care professionals over other
disciplines.\textsuperscript{21-25} The primary objective of our study
is to use COS-STAD and the COS-STAR checklists to assess the
methodological and reporting standards of OG COSs. The secondary
objectives of our research include: exploring factors that affect the
quality of developed COSs standards; and exploring how to improve
baseline standards for obstetrics and gynecology COSs development.

\textbf{Methods}

\textbf{2.1 Inclusion Criteria}

In this evaluation, OG COSs that had developed or applied methodologies
to determine which outcome areas or outcomes should be measured, or
important in clinical trials or other forms of health research, were
eligible for inclusion. We used the latest version whenever the COSs had
been updated. Studies that; only reported the use of a COS, were
systematic reviews of clinical trials, focused on systematic reviews and
surveys of outcomes measured in clinical trials or quantitative
descriptions (e.g. frequency) of outcomes, or protocol of COS, were
excluded. There were no limitations on the year of publication,
language, age of participants, and types of interventions.

\textbf{2.2 Identification and selection of COSs.}

COMET has successfully brought together the international COS literature
in an online database
(http://www.comet-initiative.org/studies/search).\textsuperscript{8} We
conducted a comprehensive search of COMET database on December 20, 2019,
one reviewer (Y.G. or J.Y.S.) exported the entire registered COS study
records from the COMET database. The full-text publications that met our
inclusion criteria were then filtered. A regularly updated systematic
review of COSs was screened to identify OG COSs as a
supplement.\textsuperscript{8} The list of COSs was reviewed by a
COS/methodology expert (J.H.Z). No restriction was placed on language.

\textbf{2.3 Data extraction and management}

All authors involved in this study had previously piloted the form on a
random sample of five included COSs to ensure the agreement among the
interpretation of data items. One reviewer (J.Y.S., M.L.Y., or Z.W.S.)
extracted data from the included COSs using a data extraction sheet from
included COSs, and a second reviewer (Y.G., Y.M.C., or M.M.N) verified
the extracted data. Any disagreements were adjudicated by the third
reviewer (J.H.T). The extracted data included: the number of authors,
countries which co-authors came from, whether the COS protocol was
registered, published journals and impact factors, number of databases
searched (Chinese, English, or both), funding source (industry,
government, unfunded, or not reported), and impact factors of journals
in which COSs included were retrieved by searching 2018 Journal Citation
Reports (Thomson Reuters, 2018) via Web of Science. Detailed scope of
data extraction tables is shown in Appendix Table 1.

\textbf{2.4 Standards assessment}

The COS-STAR was developed using a recommended approach for guiding
minimal COS study reporting. We assessed the reporting standards of
included COSs using the COS-STAR which contains 25 checklist criteria
spread over six domains namely; title/abstract, introduction, methods,
results, discussion, and other information. The responses for each item
included; ``Yes - item fully compliant, partial - item not fully
compliant, or No - item not compliant. We further assessed the
methodological standards of included COSs used COS-STAD, which contains
12 checklist criteria spread over three domains namely; scope
specification, stakeholders involved, and consensus process. These three
are considered the minimum design recommendations for all COSs
development. To indicate the degree of compliance, each checklist item
was defined as: Yes - for total addressed; Partial - for partial
addressed; and No - for not addressed. Assessments were compared, and
three authors (J.Y.S. M.L.Y., and Y.G.) deliberated on how the process
should be applied. The reporting standards assessment using the COS-STAR
tool was independently conducted by two independent reviewers (J.Y.S.
and M.L.Y.). Similarly, the methodological standards assessment using
the COS-STAD checklist was independently conducted by two reviewers
(J.Y.S and Y.G). Conflicts were adjudicated by a third reviewer
(J.H.Z.). This article is not intended to criticize the quality of the
published COSs. Therefore, we only report the compliance rates of items
included in the literature, but do not score the standards of individual
studies.

\textbf{2.5 Data analysis methods}

Median and range were used to describe continuous data, while frequency
and percentage were used for summarizing categorical data. For
individual items of the COS-STAD and COS-STAR, we summarized the
frequency of ``Yes'' response for all included systematic reviews. We
performed the Chi-square test, calculated odds ratio (OR) with 95\%
confidence intervals (95\% CIs), and obtained a P-value for each item
compared between group one (COSs with statistician or epidemiologist,
funding, and with prior protocol) and group two (without statistician or
epidemiologist, non-funding, and without protocol). Additionally, this
method was used to compare the compliance for each item of COS-STAD
between OG COSs and cancer COSs (the result of cancer COSs assessment
was extracted from a previous study conducted by Elizabeth
G).\textsuperscript{19} For each of the COS-STAR and COS-STAD checklist
items, we calculated the mean compliance items and standard deviation
(SD). The mean difference (MD) and 95\% CI were calculated for each item
to compare the overall compliance items between the groups. The MD value
represents the difference in the mean total compliance items between
group one and group two. Analyses were conducted using STATA (13.0;
Stata Corporation, College Station, Texas, USA), and statistical
significance was set at P \textless{} 0.05. The complete compliance rate
of the methodological quality was calculated with the acquired number.
Spearman correlation coefficient (r) was estimated to determine the
linear association between average citations per year (dates from Web of
Science) and the total complete compliance rates of COS-STAD and
COS-STAR for each OG COS. The correlation analyses were conducted in IBM
SPSS Statistics v. 24.0 (IBM Corp., Armonk, NY, USA), and statistical
significance set at P \textless{} 0.05.

\textbf{RESULT}

\textbf{3.1 Characteristics of included COSs}

The first COS was published in 2000; the majority published year was
2018-2019 ( Fig.1). Forty-four COSs focus on 26 topics and mainly
focused on pelvic organ prolapse (9\%) and maternity care (9\%) (
Fig.2). The included studies were conducted by the corresponding author
from nine countries, mostly in the UK (38.6\%), USA (13.6\%), Canada
(11.4\%), and Australia (9\%) ( Fig.3). The corresponding author of 40
COSs was from the developed country (91\%) and four from the developing
country (9\%). The median journal impact factor (IQR) of OG COSs
published was 5.079 (2.103, 5.357). And 13 COSs involved statistic or
epidemiologic authors. There are 6 COSs developed with 1 to 3 authors,
15 COSs developed with 4 to 6 authors, 13 COSs developed with 7 to 10
authors, 10 COSs developed with more than ten authors, and twenty-five
COSs were registered with protocol; twenty-four COSs declared funding
sources; nine COSs proclaimed that they did not receive funds, and
eleven COSs did not state whether they receive funds. Thirty-four COSs
conducted a systematic review; twenty-nine COSs reported search
strategy; only three COSs used the interview method. In addition, twenty
COSs used the Delphi method, eleven of COSs conducted two rounds of
Delphi, and nine of COSs conducted three rounds of Delphi, eighteen COSs
used consensus meeting method, only sixteen COSs (36.4\%) conducted both
scoping process and consensus process. The main characteristics of the
included COSs were presented in Table 1.

\textbf{3.2 Compliance rates of COS-STAR standards}

The compliance rates of 8 standards, mainly focusing on the introduction
and discussion sections, were \textgreater{}85\%. Moreover, the
development protocol or registration details was accessible in 56.8\% of
COSs; 68.2 \% of COSs described the sources of information for the
initial list of outcomes, 65.9\% of COSs described how outcomes were
dropped/combined, and 56.8\% of COSs outlined the final COS. 22 COSs did
not describe how outcomes were scored and how scores were summarized;
and 14 COSs did not describe whether members of the team had any
conflict of interest. The compliance rates of 10 standards on the
COS-STAR assessment were less than 55\%. These included: ''Identify in
the title that the paper reports the development of a COS'', ''Describe
the rationale for stakeholder groups involved in the COS'', ''the
sources of information for the initial list of outcomes'', ''Describe
how the consensus process was undertaken'', ''Provide a statement
regarding the ethics and consent issues for the study'', ''Describe any
changes from the protocol'', ''Present data on the number and relevant
characteristics of the people involved at all stages of COS
development'', ''List all outcomes considered at the start of the
consensus process'', ''Describe any new outcomes introduced and any
outcomes dropped'', and ''Describe sources of funding/role of funders''.
(Fig.4)

Total COS-STAR compliance standards of OG COSs with the prior protocol
were significantly higher than without protocol (MD= 3.846, 95\% CI:
0.835 - 6.858, P= 0.012) (Table 2). Table 3 shows reporting quality of
COSs. We also analyzed total compliance for each of the 25 criteria and
observed the significant differences between COSs with a priori protocol
and those without a priori protocol related to the criteria ''describe
sources of funding/role of funders'' (OR= 4.94, 95\% CI:1.26-19.32,
P=0.022 ), ''protocol/registry entry'' (OR= 39.23, 95\% CI: 2.54,606.03,
P= 0.009 ), ``describe the information sources used to identify an
initial list of outcomes.'' (OR= 2.28, 95\% CI: 1.33 - 3.89, P= 0.002),
``describe how outcomes were dropped/combined'' (OR= 2.0, 95\% CI: 1.15
- 3.47, P= 0.015), and ``describe sources of funding/role of funders''
(OR= 2.280 , 95\% CI: 1.126 - 4.617, P= 0.022).

\textbf{3.3 Results of compliance rates of COS-STAD standards}

The compliance rates of four criteria related to scope specification
were greater than 95\%. These included; ''research or practice
setting(s) in which the COS is to be applied'', ''health condition
covered by COS'', ``the population covered by COS'', and ``the
intervention covered by COS''. Twenty-one studies (52.3\%) were not
clear whether stakeholders were involved in the COS development.
Twenty-three studies (52.3\%) clearly declared that health care
professionals with experience of patients with the condition
participated in the development of COS. Fourteen COSs (31.8\%) clearly
stated patients with the condition or their representatives were
included in the process, but two COSs were not clear whether patients
were involved in the study. Thirty-five studies (92.1\%) did not
consider the views of health care professionals and patients from
literature reviews or interviews when compiling the initial list of
outcomes. Twenty studies (60.5\%) had no prior described scoring
process, consensus definition, or criteria for including/dropping/adding
outcomes. Besides, only twelve OG COSs (27.3\%) had clear accessible
registered details or published protocol. Forty-one studies (90\%) were
excluded to avoid ambiguity of language when COSs was used. (Fig.5)
Table 4 shows there was no significant difference in total COS-STAR
compliance standards of OG COSs between group one and group two.
Compared with COSs without prior protocol or registered detailed, those
studies with a priori protocol or registered details had greater
compliance rates of the standard ''Priori describe scoring
process''(OR=8.36, 95\% CI:1.18,59.24, P=0.034), ''a consensus
definition was described a priori'' (OR=8.36, 95\% CI:1.18,59.24,
P=0.034), and ''criteria for including/dropping/adding outcomes were
described a priori'' (OR=8.36, 95\% CI:1.18,59.24, P=0.034). COSs which
involved a statistician, or epidemiologist authors had higher compliance
rates on item 6 ''health care professionals with experience of patients
with the condition involved with COS developed'' (OR=0.82, 95\% CI:
0.47-1.45, P= 0.512). Moreover, we observed significant differences
between funding COSs and non-funding COSs related to the ''patients with
the condition or their representatives'' (OR= 3.35, 95\% CI: 1.08 -
10.38, P= 0.036). (Table 5). Spearman's correlation analysis revealed a
statistically significant (p \textless{} 0.05) positive correlation
between average citations per year and the compliance rates of COS-STAD
for OG COSs. (Table 6).

\textbf{3.4 Comparisons between cancer COSs and OG COSs}

A previous study conducted by Elizabeth G about the minimum standard
assessments of cancer COSs showed that compliance rates for both four
standards in scope domain were greater than 95\%, which was consistent
with OG COSs.\textsuperscript{19} The compliance rates for ``Patients
with the condition or their representatives'' were both less than 35\%
in cancer COSs and OG COSs. Compared to OG COSs, the cancer COSs had the
same low compliance rate for all five standards in consensus process
standards ( \textless{}30\%), but had lower compliance rates for ``A
scoring process was described a priori'' (OR=0.37, 95\% CI: 0.14 - 0.97,
P=0.045) and ``Criteria for including/dropping/adding outcomes were
described a priori'' (OR=0.15, 95\% CI:0.03 - 1.09, P=0.63). Further, no
significant difference was found in the compliance rates in other
criteria between cancer COSs and OG COSs. (Table 7).

\begin{enumerate}
\tightlist
\item
  \textbf{Discussion}
\item
  \textbf{Summary of characteristics of included COSs}
\end{enumerate}

We identified 44 OG COSs from 26 research topics, with pelvic organ
prolapse, and maternity care being the most common. The first OG COSs
was published in 2000, and the number has gradually increased over the
years. Most OG COSs were published between 2017 2018. 91\% of the
published COSs were published by corresponding authors from the
developed countries, and 86.4\% of COSs were developed by more than
three authors. Identification of an inclusive list of outcomes from the
existing literature is critical to the development of a core outcome
set.\textsuperscript{7} The main data sources include systematic reviews
of published studies, reviews of published qualitative work, reviews of
criteria in the national audit data set, and interviews with key
stakeholders.\textsuperscript{16, 26} However, only three COSs
interviewed key stakeholders to understand their views of important
outcomes, and 16 \% of COSs did not conduct systematic/literature review
to identify existing knowledge about outcomes. Given that the
comprehensiveness of the results of the systematic review is highly
dependent on the results of the underlying data, there is a need for
thorough verification of reported results. Unfortunately, only 34.1\% of
COSs searched more than three databases. Nevertheless, it should be
noted that the systematic review of the results merely aggregates the
opinions of previous researchers. Therefore, it is crucial to
subsequently strike a consensus with the wider community of stakeholders
on the outcomes to be included in a COS. In the present study, only
twenty COSs (45.5\%) conducted two or more rounds of Delphi survey,
40.9\% of COSs used the consensus meeting method, and 36.4\% of studies
used both the systematic review and consensus methods.

\textbf{4.2 Reporting standards of included COSs}

For the COS-STAR checklist, only 34.1\% of studies can identify in the
title that the paper reports the development of a COS. The compliance
rates of 8 criteria belonging to ''introduction'' and ''discussion''
sections were greater than 85\%, and the compliance rates of 9 criteria
in the methods section ranged from 27.3\% - 68.2\%. The influence of
methodology on the quality of COSs was considered significant. More than
a third of the studies did not fully report protocol/registry entry,
information sources, and funding sources, which may reduce the
transparency of the COS developed. Moreover, only a few studies
published their protocol on peer-reviewed journals, and most registered
with limited information. We could not find any registration information
or published protocol for more than 40\% of COSs. Given that no study
met the item 11 criterion (describe any changes from the protocol),
further consideration is needed whether COS not deviating from the
protocol should report this item. This would improve the applicability
and suitability of this criterion. The characteristics of the people
involved were not presented in 61.4\% of studies. All outcomes
considered at the start of the consensus process and descriptions of any
other outcomes introduced/dropped during the consensus process were
absent in more than half of the studies. The recommended outcomes in
43.2\% of COSs were unclear or ambiguous, which may limit their use.
Only twenty-four (54.5\%) COSs met all two other information criteria
(sources of funding and conficts of Interest). Total COS-STAR compliance
criteria of OG COSs was significantly positively correlated with prior
protocol, indicating that COS developed with prior protocol may improve
the reporting quality of COS reporting. Therefore, further studies
should consider improving the transparency and robustness of the
reporting standard through publishing a previous protocol based on Core
Outcome Set-STAndardised Protocol Items (COS-STAP)
statement.\textsuperscript{3}

\textbf{4.3 Methodological standards of included COSs}

For COS-STAD checklist, more than 95\% of COSs met all four standards
for scope specification. In addition, most clearly described the
research or practice setting in which COS was applied, and the health
condition, population, and intervention covered by the COS. The decision
as to which outcomes are core to measure, and why is an important
process. Fourteen COSs (31.8\%) met all the three standards for the
domain of stakeholders involved; based on the author affiliations or
participant lists, twenty-four (54.5\%) of COSs were developed by people
intending to use the COS in research, and health care professionals with
experience of patients with the condition; sixteen COSs (36.4\%) did not
describe the inclusion of patients with the condition or their
representatives. All the stakeholders involved in the COS development
should be reported to ascertain whether the COS fully reflects the views
of important outcomes for the target population in the forthcoming
research. This would be conducive to the utilization and promotion of
the COS.\textsuperscript{23} Given the difficulty to judge the standards
of COS-STAD in the consensus process that was set in advance, we
determined whether the studies that met this standard rely on the
registration information and published protocol.\textsuperscript{19}Only
27.3\% of COSs priori described a consensus protocol, and some
registration information was inadequately reported, making it difficult
to judge whether some standards were set prior. We suggest that the
registration platform could improve the standards for COS registration,
thereby promoting the integrity and transparency of COS developed.
92.1\% of COSs did not report whether the patient representatives
received a glossary of terms before completing the survey, which may
cause ambiguity of language. Compared with COSs without prior protocol
or registered detailed, those studies with a priori protocol or
registered detailed had higher compliance rates of ``describe consensus
definition'' and ``criteria for including/dropping/adding outcomes
consensus process in advance.'' Besides, we found that COSs developed
with statistical or epidemiologist authors incorporated the views of
healthcare professionals on important outcomes. Compared to cancer COSs,
OG COSs similarly had a high compliance rate for standards in the scope
domain, and low compliance rates for the standards in the field of
stakeholders involved and consensus process.\textsuperscript{19}

\textbf{4.4 Strengths and limitations}

To the best of our knowledge, this is the first study to investigate the
characteristics of OG COSs and assess whether the OG COSs meet the
minimum design standards and minimal COS study reporting requirements
set by COS-STAD checklist. In addition, we explore the potential factors
that may impact the methodological and reporting standards of COSs.

This work had the following limitations. First, some studies only
conducted the scoping process or consensus process which led to the low
reporting rate of some criteria. However, because we focused on
investigating the current issues of COSs and explored how to improve the
COS standards instead of criticizing the quality of the existing COSs,
the impact of this limitation was limited. Second, some of the included
COSs were published before the COMET initiative was set up, hence were
not registered. Therefore, our definition of COSs developed with the
protocol was not limited to this website, but also other registration
platforms, and protocols published in the peer-reviewed journal that met
our set criteria. Third, we applied the same COS-STAD criteria to
compare the standards between OG COSs with cancer COSs based on previous
research. Moreover, variation in standards for item compliance may also
exist in the assessment progress between different reviewers. Given that
COS-STAD and COS-STAR did not provide a standard to score the overall
quality of COSs, our analysis was limited to the compliance rate.
Further studies are required to explore the appropriate statistical
methods for estimating an average value of the quality scores of
multiple COSs.

\textbf{Conclusion}

The compliance of COS-STAD and COS-STAR criteria in OG COSs are not
optimistic. Therefore, the reporting and methodological standards of OG
COSs should be further improved, especially, the design of important
stakeholders involved and consensus process; and reporting standards in
methods, results, and other information specifications. OG COS developed
with the prior protocol is beneficial to improve the reporting
standards.

\textbf{Disclosure of interests:} We declare that we have no competing
interests

\textbf{Contribution to authorship:}

\textbf{Jiyuan Shi:} Conceptualization, Data curation, Formal analysis,
Investigation, Methodology, Software, Visualization, Writing - original
draft, Writing - review \& editing. \textbf{Ya Gao:} Conceptualization,
Data curation, Formal analysis, Investigation, Methodology, Software,
Writing - review \& editing. \textbf{Mingming Niu:} Data curation,
Investigation, Resources. \textbf{Meili Yan:} Formal analysis, Data
curation, Resources, Software, Validation. \textbf{Yamin
Chen:}Investigation, Resources, Data curation. \textbf{Ziwei Song,} Data
curation, Resources. \textbf{Yuanyuan Li,} Data curation,
Resources.\textbf{Liu Ming,} Data curation, Resources. \textbf{Jinhui
Tian:}Conceptualization, Formal analysis, Methodology, Project
administration, Resources, Software, Supervision, Validation, Writing -
original draft, Writing - review \& editing. \textbf{Junhua Zhang:}
Conceptualization, Formal analysis, Methodology, Project administration,
Resources, Software, Supervision, Validation, Writing - original draft,
Writing - review \& editing.

\textbf{Details of ethics approval:} Not applicable.

\textbf{Funding:} None.

\textbf{Acknowledgements:} We would like to acknowledge: (1) the COMET
Initiative team for methodological support; (2) Methodological guidance:
Elizabeth Gargon , University of Liverpool, United Kingdom.

\textbf{Ethics approval and consent to participate:} Not applicable.

\textbf{REFERENCES:}

\begin{enumerate}
\tightlist
\item
  Williamson PR, Altman DG, Bagley H, Barnes KL, Blazeby JM, Brookes ST,
  et al. The COMET Handbook: version 1.0. Trials 2017, 18(Suppl 3):280.
\item
  Li X, Ya Z, Chen Y, Yang K, Zhang Z. The reporting characteristics and
  methodological quality of Cochrane reviews about health policy
  research. Health policy 2015, 119(4):503-510.
\item
  Kirkham JJ, Gorst S, Altman DG, Blazeby JM, Clarke M, Tunis S, et al.
  Core Outcome Set-STAndardised Protocol Items: the COS-STAP Statement.
  Trials 2019, 20(1):116.
\item
  Kirkham JJ, Dwan KM, Altman DG, Gamble C, Dodd S, Smyth R, et al The
  impact of outcome reporting bias in randomised controlled trials on a
  cohort of systematic reviews. BMJ 2010, 340:c365.
\item
  Gorst SL, Prinsen CA, Salcher-Konrad M, Matvienko-Sikar K, Williamson
  PR, Terwee CB. Methods used in the selection of instruments for
  outcomes included in Core Outcome Sets have improved since the
  publication of the COSMIN/COMET guideline. J Clin Epidemiol 2020
  26;125:64-75.
\item
  Davis K, Gorst SL, Harman N, Smith V, Gargon E, Altman DG, et al.
  Choosing important health outcomes for comparative effectiveness
  research: An updated systematic review and involvement of low and
  middle income countries. PloS one 2018, 13(2):e0190695.
\item
  Kirkham JJ, Altman DG, Chan AW, Gamble C, Dwan KM, Williamson PR.
  Outcome reporting bias in trials: a methodological approach for
  assessment and adjustment in systematic reviews. BMJ 2018, 362:k3802.
\item
  Gargon E, Gorst SL, Williamson PR. Choosing important health outcomes
  for comparative effectiveness research: 5th annual update to a
  systematic review of core outcome sets for research. PloS one 2019,
  14(12):e0225980.
\item
  Gargon E, Gorst SL, Harman NL, Smith V, Matvienko-Sikar K, Williamson
  PR. Choosing important health outcomes for comparative effectiveness
  research: 4th annual update to a systematic review of core outcome
  sets for research. PloS one 2018, 13(12):e0209869.
\item
  Wuytack F, Smith V, Clarke M, Williamson P, Gargon E. Towards core
  outcome set (COS) development: a follow-up descriptive survey of
  outcomes in Cochrane reviews. Syst Rev 2015, 4:73.
\item
  Gargon E, Gurung B, Medley N, Altman DG, Blazeby JM, Clarke M, et al.
  Choosing important health outcomes for comparative effectiveness
  research: a systematic review. PloS one 2014, 9(6):e99111.
\item
  Gorst SL, Gargon E, Clarke M, Smith V, Williamson PR. Choosing
  Important Health Outcomes for Comparative Effectiveness Research: An
  Updated Review and Identification of Gaps. PloS one 2016,
  11(12):e0168403.
\item
  Gorst SL, Gargon E, Clarke M, Blazeby JM, Altman DG, Williamson PR.
  Choosing Important Health Outcomes for Comparative Effectiveness
  Research: An Updated Review and User Survey. PloS one 2016,
  11(1):e0146444.
\item
  Gorst SL, Young B, Williamson PR, Wilding JPH, Harman NL.
  Incorporating patients' perspectives into the initial stages of core
  outcome set development: a rapid review of qualitative studies of type
  2 diabetes. BMJ Open Diabetes Res Care 2019, 7(1):e000615.
\item
  Kirkham JJ, Davis K, Altman DG, Blazeby JM, Clarke M, Tunis S, et al.
  Core Outcome Set-STAndards for Development: The COS-STAD
  recommendations. PLoS Med 2017, 14(11):e1002447.
\item
  Biggane AM, Brading L, Ravaud P, Young B, Williamson PR. Survey
  indicated that core outcome set development is increasingly including
  patients, being conducted internationally and using Delphi surveys.
  Trials 2018, 19(1):113.
\item
  Kirkham JJ, Bracken M, Hind L, Pennington K, Clarke M, Williamson PR.
  Industry funding was associated with increased use of core outcome
  sets. J Clin Epidemiol 2019, 115:90-97.
\item
  Kirkham JJ, Gorst S, Altman DG, Blazeby JM, Clarke M, Devane D, et al.
  Core Outcome Set-STAndards for Reporting: The COS-STAR Statement. PLoS
  Med 2016, 13(10):e1002148.
\item
  Gargon E, Williamson PR, Blazeby JM, Kirkham JJ. Improvement was
  needed in the standards of development for cancer core outcome sets. J
  Clin Epidemiol 2019, 112:36-44.
\item
  De la Fuente-Solana EI, Suleiman-Martos N, Pradas-Hern\selectlanguage{ngerman}ández L,
  Gomez-Urquiza JL, Cañadas-De la Fuente GA, Albendín-García L.
  Prevalence, Related Factors, and Levels of Burnout Syndrome Among
  Nurses Working in Gynecology and Obstetrics Services: A Systematic
  Review and Meta-Analysis. Int J Environ Res Public Health 2019,
  16(14).
\item
  Al Wattar BH, Tamilselvan K, Khan R, Kelso A, Sinha A, Pirie AM, et
  al. Development of a core outcome set for epilepsy in pregnancy
  (E-CORE): a national multi-stakeholder modified Delphi consensus
  study. BJOG 2017, 124(4):661-667.
\item
  Pergialiotis V, Durnea C, Elfituri A, Duffy JMN, Doumouchtsis SK. Do
  we need a core outcome set for childbirth perineal trauma research? A
  systematic review of outcome reporting in randomised trials evaluating
  the management of childbirth trauma. BJOG 125(12):1522-1531.
\item
  Gargon E, Williamson PR, Young B. Improving core outcome set
  development: qualitative interviews with developers provided pointers
  to inform guidance. J Clin Epidemiol 2017, 86:140-152.
\item
  Tunis SR, Clarke M, Gorst SL, Gargon E, Blazeby JM, Altman DG, et al.
  Improving the relevance and consistency of outcomes in comparative
  effectiveness research. J Comp Eff Res 2016, 5(2):193-205.
\item
  Duffy JMN, Thompson T, Hinton L, Salinas M, McManus RJ, Ziebland S, et
  al. What outcomes should researchers select, collect and report in
  pre-eclampsia research? A qualitative study exploring the views of
  women with lived experience of pre-eclampsia. BJOG 2019,
  126(5):637-646.
\item
  Gorst SL, Altman DG, Blazeby JM, Clarke M, Gargon E, Tunis S, et al.
  Proceedings of the 5th Meeting of the Core Outcome Measures in
  Effectiveness Trials (COMET) Initiative. Trials 2015, 16 Suppl 3(Suppl
  3):A1-p11.
\end{enumerate}

\textbf{Hosted file}

\verb`Table 1 Characteristics of the included COSs.docx`  available at \url{https://authorea.com/users/344833/articles/471219-improvement-was-needed-in-the-standards-of-development-for-obstetrics-and-gynecology-core-outcome-sets}

\textbf{Hosted file}

\verb`Table 2. Stratified analyses of reporting quality assessm.docx`  available at \url{https://authorea.com/users/344833/articles/471219-improvement-was-needed-in-the-standards-of-development-for-obstetrics-and-gynecology-core-outcome-sets}

\textbf{Hosted file}

\verb`Table 3 Stratified analyses of reporting quality a.docx`  available at \url{https://authorea.com/users/344833/articles/471219-improvement-was-needed-in-the-standards-of-development-for-obstetrics-and-gynecology-core-outcome-sets}

\textbf{Hosted file}

\verb`Table 4 Stratified analyses of reporting quality a.docx`  available at \url{https://authorea.com/users/344833/articles/471219-improvement-was-needed-in-the-standards-of-development-for-obstetrics-and-gynecology-core-outcome-sets}

\textbf{Hosted file}

\verb`Table 5. Stratified analyses of metho.docx`  available at \url{https://authorea.com/users/344833/articles/471219-improvement-was-needed-in-the-standards-of-development-for-obstetrics-and-gynecology-core-outcome-sets}

\textbf{Hosted file}

\verb`Table 6.  Correlation analysis of report or design.docx`  available at \url{https://authorea.com/users/344833/articles/471219-improvement-was-needed-in-the-standards-of-development-for-obstetrics-and-gynecology-core-outcome-sets}

\textbf{Hosted file}

\verb`Table 7. Stratified analyses of COS-STAD compliance.docx`  available at \url{https://authorea.com/users/344833/articles/471219-improvement-was-needed-in-the-standards-of-development-for-obstetrics-and-gynecology-core-outcome-sets}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Figure-1/Figure-1}

\end{center}
\end{figure}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Figure-2/Figure-2}

\end{center}
\end{figure}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Figure-3/Figure-3}

\end{center}
\end{figure}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Figure-4/Figure-4}

\end{center}
\end{figure}\selectlanguage{english}
\begin{figure}[H]
\begin{center}
\includegraphics[width=0.70\columnwidth]{figures/Figure-5/Figure-5}

\end{center}
\end{figure}

\selectlanguage{english}
\FloatBarrier
\end{document}

