BACKGROUND:Patient, carer and public involvement (PCPI), an approach being endorsed in research, may also improve research integrity. After prospective registration (https://osf.io/nfgxp), we conducted a scoping umbrella review to collate evidence on the contribution of PCPI toward the integrity of randomized clinical trials (RCTs). METHODS:Three databases were searched on 17 July 2024 with a double-blind selection process. We included systematic reviews that addressed PCPI issues related to clinical research integrity. Quality was appraised with a modified AMSTAR-2 instrument. RESULTS:We identified 27 reviews. The overlap between primary studies was low. The quality of the reviews was rated as high-moderate for two, low for four, and critically low for 21. Findings on adherence to ethical and professional standards emphasized the importance of early citizen engagement in RCTs, the role of PCPI in the ethical approval process, and the need for research integrity training. There was a lack of research on the role of PCPI relating to post-publication issues. CONCLUSION:Our findings supported the need for developing a consensus approach to ascertain the role of PCPI in responsible RCT design, conduct, and reporting, to enhance the credibility and trustworthiness of clinical research.

Recent studies have revealed issues with ethical practice and informed consent in randomized clinical trials (RCTs). We aimed to develop an international, multi-stakeholder consensus statement on human research ethics committee approval and informed participant consent for RCTs. The consensus process encompassed a systematic scoping review, modified two-round Delphi survey, and final consensus meeting of a multi-stakeholder group, including trialists, ethics committee members, methodologists, patient representatives, journal editors, and other experts on RCTs. Delphi consensus deployed the Average Percentage of Majority Opinions (APMO) threshold. There were 36 stakeholders from 12 countries in five continents. Delphi survey response rates were 67% (24/36 stakeholders) and 69% (25/36 stakeholders) in the first and second rounds, respectively. There were 135 statements (18 stakeholder-provided, 117 scoping review-generated) in the initial long list. Three additional statements were provided during the Delphi rounds. APMO threshold was 81.33% and 75.05% for the first and second Delphi rounds, respectively. Through consensus, the final set consolidated 77 statements in the following domains: general aspects (n = 11), journals' instructions and policies (n = 9), research institutions and funders' policies (n = 6), ethics committee regulations (n = 11), ethics committee evaluation and approval (n = 18), monitoring of informed consent procedures (n = 8), monitoring of trials for compliance (n = 3), post-publication concerns on ethics (n = 2), and recommendations for future research and development (n = 9). In conclusion, this international consensus statement provides a comprehensive integrity framework to address the unique challenges in RCT ethics and informed consent. It highlights the importance of robust ethics committee assessments, stakeholder training, patient engagement, and trial monitoring procedures.

The number of retractions of randomized clinical trials (RCTs) following post-publication allegations of misconduct is increasing. To address this issue, we aimed to establish an international multistakeholder consensus on post-publication integrity concerns related to RCTs. After prospective registration (https://osf.io/njksm), we assembled a multidisciplinary stakeholder group comprising 48 participants from 18 countries across six continents, recruited using a curated list of journal editors and snowballing. An underpinning evidence synthesis collated 89 articles related to post-publication integrity concerns. Integrity statements related to RCTs created were subjected to anonymized two-round Delphi survey. A hybrid face-to-face-online consensus development meeting was convened to consolidate the consensus. The response rates of the two Delphi survey rounds were 65% (31/48) and 67% (32/ 48), respectively. There were 101 and 41 statements in the first and second Delphi rounds, respectively. After the two Delphi rounds and the consensus development meeting, consensus was achieved on 104 statements consolidated to 84 after merging, editing, and removing duplicates. This set of statements included general aspects (n = 9), journal instructions (n = 14), editorial and peer review (n = 7), correspondence and complaints (n = 4), investigations for integrity concerns (n = 16), decisions and sanctions (n = 9), critical appraisal guidance (n = 1), systematic reviews of RCTs (n = 8), and research recommendations (n = 16). In conclusion, this international multistakeholder consensus statement aimed to underpin policies for preventing post-publication integrity concerns in RCT publications and assist in improving investigations of misconduct allegations.

Deputy Editor‐in‐Chief, Dr Patrick Chien, discusses his top articles from this issue in an audio podcast available at: https://soundcloud.com/bjog/bjog-january-2024-editorial

doi: https://doi.org/10.12669/pjms.40.8.9779 How to cite this: Chien PFW, Khan KS, Fawzy M, Khalaf Y. Cairo Consensus Statement on Research Integrity of Randomised Clinical Trials. Pak J Med Sci. 2024;40(8):---------. doi: https://doi.org/10.12669/pjms.40.8.9779 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

BackgroundPost-publication handling of integrity concerns in randomized clinical trials (RCTs) is a contentious matter.ObjectivesWe undertook a scoping systematic review to map the literature regarding post-publication integrity issues in RCTs.Search Strategy and Selection CriteriaFollowing prospective registration () we initially searched PubMed and Scopus but subsequently extended it to include the Cochrane Library, and Google Scholar databases without language, article type or publication time restriction until November 2022. Reviewers independently selected published articles covering any aspect of post-publication research integrity concerns in RCTs.Data Collection and AnalysisThe study findings grouped within domains relating to issues concerning post-publication integrity were extracted in duplicate, verified by a third reviewer, and then tabulated.Main ResultsThe initial search captured 3159 citations, of which 89 studies were included in the review. Cross-sectional studies constituted the majority of included studies (n = 34, 38.2%), followed by systematic reviews (n = 10, 11.2%), methodology reviews/studies (n = 9, 10.1%) and other types of descriptive studies (n = 8, 9.0%). A total of 21 articles (23.6%) covered the domain on general issues, 25 (28.1%) in the journal's instructions and policies domain, eight (9.0%) in the editorial and peer review domain, one (1.1%) in the correspondence and complaints (post-publication peer review) domain, 12 (13.5%) in the investigation for concerns domain, six (6.7%) in the post-investigation decisions and sanctions domain, none in the critical appraisal guidance domain, five (5.6%) in the integrity assessment in systematic reviews domain, and 26 (29.2%) in the recommendations for future research domain. A total of 12 of the selected articles (13.5%) covered two (n = 9) or three (n = 3) different domains.ConclusionsVarious research integrity domains and issues covering post-publication aspects of RCT integrity were captured and gaps were identified, mostly related with the necessary implications for all stakeholders to improve research transparency. There is an urgent need for a multistakeholder consensus towards creating specific statements for addressing post-publication integrity concerns in RCTs. Existing literature concerning post-publication integrity issues in randomized clinical trials needs consolidation.

Deputy Editor‐in‐Chief, Dr Patrick Chien, discusses his top articles from this issue in an audio podcast available at: https://soundcloud.com/bjog/June‐editorial‐2024

In this issue, I like to highlight some of the issues relating to the quality of life for women with advanced epithelial ovarian cancer undergoing treatment. I will also focus on 2 further articles relating to the follow up of women with endometrial cancer and the obstetric outcomes in the small group of women who had fertility sparing treatment for this disease. The incidence of ovarian cancer on a global scale is variable with declining rates in regions with high socio-demographic index (SDI) but increasing rates in areas with low SDI (Zhang S, et al. BMC Public Health. 2022; 22:1455. doi: 10.1186/s12889-022-13 861-y). In the USA, there has been a decline of 33% in mortality from this disease from 1976 to 2015 (Torre LA, et al. CA Cancer J Clin 2018; 68:284–96 doi: 10.3322/caac.21456). As the overall survival for women with advanced epithelial ovarian cancer is similar for those treated with neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS) compared to those undergoing primary debulking surgery (PDS), the quality of life for those women undergoing these treatments then becomes clinically important. Marchetti and colleagues therefore conducted a randomised controlled trial comparing the quality of life for those women receiving treatment with NACT followed by IDS versus those treated with PDS (pages 1579–1588). The study was powered for major perioperative morbidity as the primary outcome with 171 participants randomised. In this article, the result of the global quality of life measure at 12 months following treatment was reported as a secondary end-point. The result showed that there was no difference in the global quality of life scores between the study groups. This conclusion should, however, be interpreted with some caution as only 69% of the participants in the NACT/IDS group and 78% of the those in the PDS group actually completed the quality of life questionnaires at 12 months following treatment. Furthermore, being a secondary outcome, the study was not powered for this outcome. It, however, does lend some evidence towards using the NACT/IDS approach as an alternative option to those patients whereby PDS is not feasible but further well designed and adequately powered clinical trials are required to definitively answer this question. The accompanying mini-commentaries by Fotopoulou (pages 1591–1592) and Morrison (pages 1589–1590) also concur with the caveats described above on the findings of this study. With endometrial cancer, the incidence of the disease is increasing (Constantine GD, et al. J Womens Health. 2019; 28:237–43. doi: 10.1089/jwh.2018.6956) but mortality is decreasing in the USA (Ran X, et al. JNCI Cancer Spectr. 2023; 7:pkac082. doi: 10.1093/jncics/pkac082). In contrast to ovarian cancer, endometrial cancer can present with early disease and patients may have no residual macroscopic disease following surgery with or without adjuvant radiotherapy. In such cases, such patients may consider the follow up for recurrence of this disease an important clinical issue for them. Rulanda and colleages reported the result of the fear of cancer recurrence (FCR), quality of life and healthcare usage for women undergoing patient initiated (PIFU) versus hospital-based (HBFU) follow up for early stage endometrial cancer (pages 1593–1601). The original report (OPAL trial) was based on FCR measurement after 10 months of follow up. In this article, the authors reported a secondary analysis of FCR at a longer follow up period of 34 months. The study showed that FCR decreased from baseline in both study groups with no significant difference between the two groups. There was also no difference in the quality of life but the use of healthcare resources was significantly lower in the PIFU group. The authors therefore concluded that patient initiated follow up is a valid alternative to follow up within a hospital setting for women previously treated for early endometrial cancer. International practice guidelines on the follow up for this disease (Koppikar S, et al. ESMO Open. 2023; 8:100774. doi: 10.1016/esmoop.2022.100774) may need to be updated to incorporate the option of allowing patients to be given the choice for their follow up. The standard treatment for early stage endometrial cancer involves undergoing a hysterectomy and bilateral hysterectomy and the disease commonly presents in postmenopausal women. In recent years, the incidence of disease in younger nulliparous women is increasing, albeit still rare. For such women, fertility sparing treatment with progestogen treatment for early stage, low grade disease has been advocated and Shim and colleagues reported on the obstetric outcome on a cohort of women with and without a previous history of such disease (pages 1662–1668). The study reported an increased risk of multiple gestations, caesarean section and preterm birth following adjustment for the possible confounding effect of maternal age, primiparity and other co-morbidities. When a sensitivity analysis was performed on singleton pregnancies alone, the risk of preterm birth was no longer increased in women with a previous history of endometrial carcinoma. The information from this study will be useful for counselling those women who may wish to consider conceiving after successful conservative treatment for this disease. Lastly, I just like to take this opportunity to wish our readers, contributors, reviewers, support staff and fellow editors a very Merry Christmas and happy New Year for 2024. Thank you all for your continuing support for BJOG.

The integrity of randomized clinical trials (RCT) has become a concern owing to a recent rise in the number of retractions and the repercussions this has for evidence-based patient care. However, there is little research on the subject of RCT integrity assessment. Recent literature reviews have revealed that journals' authors' instructions concerning integrity and their investigation policies concerning allegations of misconduct are heterogeneous. The judicious use of integrity tests applied to RCT manuscripts is hampered by an absence of data concerning misconduct prevalence (pre-test probability), a failure to evaluate test performance (validity) and a lack of consensus over a gold standard (against which test accuracy can be evaluated). These deficiencies hinder the post-publication correction of RCT records, the integrity evaluations in systematic reviews of RCTs and the prospective application of preventive solutions in RCT peer-review and preprint assessment. Dealing with the current controversy about trustworthiness of RCT evidence requires a strong investment in research, reform and education concerning research integrity. The purpose of this review article is to highlight the current limitations in dealing with trial integrity-related concerns and to propose solutions to some of these issues.

Background: The trustworthiness of randomised clinical trials (RCTs) is suffering a crisis of confidence. Objectives: We undertook an umbrella review of the research integrity literature concerning RCTs. Search strategy and selection criteria: Following prospective registration (https://osf.io/3ursn), two reviewers independently searched PubMed, Scopus, Cochrane Library and Google Scholar, without language or time restrictions until November 2021. We included systematic reviews covering any aspect of research integrity throughout the RCT lifecycle. Data collection and analysis: We assessed methodological quality using a modified AMSTAR-2 tool and collated the main findings. Main results: There were 55 relevant reviews summarising a total of 6001 studies (median per review 63; range 8-1106 studies). The overall quality of 53 (96.4%) reviews was critically low. Eight (14.6%) reviews focused on the general aspects of a RCT, 12 (21.8%) on the design and approval, 6 (10.9%) on the conduct and monitoring, 21 (38.2%) on the reporting of protocols and findings, one (1.8%) on post-publication concerns and 7 (12.7%) on future research and development. The integrity issues covered were varied, the most common being the importance of ethics (10/55, 18.2%) and transparency (10/55, 18.2%). Conclusions: Various research integrity issues covering RCT lifecycle, captured from mostly low-quality reviews, provided a broad overview emphasising the need for high level of ethical standards and professionalism. Many gaps in the RCT integrity landscape were also identified. There is a need to generate multistakeholder consensus to create specific RCT integrity standards.

I like to highlight the importance of using data from secondary analyses of randomised controlled trials to guide clinical practice by publishing together a series of articles relating to the hypertension during pregnancy. In these cases, it may be not feasible to undertake a further randomised controlled trial to test a more refined and specific hypothesis due to the lack of equipoise following the reporting of the findings from the original trial.

Deputy Editor‐in‐Chief, Dr Patrick Chien, discusses his top articles from this issue in an audio podcast available at: https://soundcloud.com/bjog/October-editorial-2022

The International Day of Action for Women's Health falls on 28th May. It is therefore most appropriate that I devote my editorial to highlight articles that report on initiatives and the science to improve women's health. It is now generally accepted that a modern maternity healthcare service should encompass a surveillance system to identify and review all maternal and perinatal deaths in order to learn lessons from such outcomes. It is hoped that such a learning system will lead to improvements in maternity care and the health of pregnant women. The World Health Organisation (WHO) has recently launched their global technical guidelines on maternal and perinatal death surveillance and response (MPDSR) with operational guidance and tools for the implementation of such surveillance systems. One of the barriers identified in the successful uptake of MPDSR is the blame culture which still exists within healthcare systems. In this issue of BJOG, Kinney and colleagues discussed ten strategies on how to identify and deal with the blame culture associated with MPDSR (pages 839–844). They also highlighted that this culture can exist at 3 different levels within a healthcare system: individual (micro), organisational (meso) and national policy and political (macro) levels. At each level, supportive measures need to be in place to minimise this culture of blame. Most obstetricians will be familiar with such clinical reviews at departmental or hospital level but there is often a lack of participation and engagement at the organisational level. For example, when there is an adverse intrapartum outcome and the lack of resources such as the absence of a sufficient number of midwives and other staff in the labour ward, has been identified as a contributor to this outcome, it is not uncommon for this issue to remain as a low priority within the healthcare organisation.. Instead, the ‘blame’ is shifted to some other individuals or factors instead. Another barrier to the implementation of MPDSR is the lack of protected professional time being allocated for such reviews. Although there may be sessions allocated for administrative work and meetings for attendance at morbidity and mortality meetings in formal job plans, clinicians are quite often asked to fill for absences by colleagues at clinics, operating theatres and on-calls due to sickness and other unforeseen reasons. Unless there is engagement at all levels of the healthcare organisation with this process, such barrier will continue to hamper progress in the improvement of women's health care. The use of hormonal contraception has allowed women to control their fertility and also in some case also to treat heavy and/or irregular menstrual bleeding. There has been concern about the possible association between hormonal contraceptive use and subsequent depression. Lundin and colleagues reported their findings from a large population based study in Sweden on the lack of an association between the combined oral contraceptive pill with depression for girls aged 15–24 years old (pages 917–925). There was a small increased risk for those taking the progestogen-only pill, especially those in the younger 15–19 years age group. The use of non-oral hormonal contraceptives was also associated with small increased risks for depression compared with non-users. This study should provide further assurance that oral hormonal contraception is generally safe for clinical use. Another important determinant of women's health is the availability of convenient and safe provision of early termination of pregnancy. In the UK, the Covid-19 pandemic has resulted in the early termination of pregnancy (up to 10 weeks of gestation) service being delivered almost exclusively with telemedicine. Patients undergo a telephone consultation with a nurse. Provided that there is no ambiguity with the gestation of the pregnancy from the last menstrual period and there are no legal or medical contraindication for the procedure, the therapeutic agents (mifepristone and misoprotol) are posted out to women seeking this service with clear instructions on self-administration. Women are also given contact details of the service should there be any concerns or problems encountered with the procedure. They are also requested to undertake a subsequent urine pregnancy test at home after the procedure to ensure that it has been successful. On pages 969–975, Regan and colleagues reported that maintaining this model of care for this service in the UK can potentially save between £1.5 and £3.0 million per year. It has now been suggested that this model of care maybe the norm for this service even after the pandemic is over. Lastly, I need to pay tribute to the bravery and resilience of the Ukrainian people in standing up to the unprovoked aggression from outside their country. One can only hope that this conflict, which is generating an immense amount of human tragedy, will end soon. I am also touched to see the offer of generous help provided people from the neighbouring countries and beyond. I had the pleasure to visit Kyiv back in 2013 to teach on the development of clinical guidelines and was warmly welcomed there. Almost the entire world is united to be with of the people of Ukraine.

In this issue, I like to highlight several articles examining the impact of childbirth on subsequent women's health. Delivering a baby is one of most memorable moments in a woman's life experience but it can also lead to short and life-long consequences. Worldwide, postpartum haemorrhage (PPH) remains a major cause of maternal morbidity and death. Ladfors and colleagues (pages 562–571) examined the delivery records of over 1.5 million deliveries classified as Robson groups 1–5 (term, singleton pregnancies in vertex presentation) in a national Swedish register between 2000 and 2016 in order to examine the temporal trends in PPH and also to assess for any maternal, comorbidity and obstetric practice risk factors to explain for any observed change. PPH was defined as blood loss at delivery >1 L. Over this time period, the incidence of PPH increased by 37% with the risk factors studied only being able to explain a small proportion of the observed change. The incidence of PPH increased in all the Robson groups studied except for those women who had pre-labour caesarean section. The findings from this study is highly dependent on the accuracy of the blood loss measured at delivery. As expected, the blood loss at a vaginal delivery was estimated visually or by weighing pads which has been known to be potentially inaccurate and hence inflate the actual amount of blood loss. So what if the diagnosis of PPH is being made more frequently when the incidence of maternal death may not be increasing especially in a high income country like Sweden. On pages 550–561, Meh and colleagues examined the temporal trend in maternal mortality in India over 2 decades (1997–2020). Although there is a 70% reduction in the maternal mortality rate over this period, there is still a wide disparity with this rate between the poorer northern and north-eastern states compared to elsewhere in the country. The leading causes of death are maternal haemorrhage, pregnancy-related infection and hypertensive disorder of pregnancy. This suggest that a significant number of such deaths are still occurring during childbirth from haemorrhage and hence the need to be able to provide high quality intrapartum care. Another possible sequelae from childbirth is injury to the pelvic floor and/or bladder neck with the possibility for the need for surgery and the risk of potential treatment complications and failure. Rusavy and colleagues conducted a comprehensive systematic review to compare the risk of levator avulsion (LA) following childbirth on pages 517–528. From this review, it appears that having a caesarean section is associated with the lowest risk of LA (1%), irrespective of whether this outcome was ascertained using MRI or pelvic ultrasound scanning. Compared to this mode of delivery, the odds of LA with a spontaneous vaginal delivery was 10.7 times higher. The odds ratio of sustaining a LA with a ventouse and forceps delivery was 1.7 and 6.3 respectively when compared to a spontaneous vaginal delivery. In studies with a head-to-head comparison between forceps and ventouse delivery, the odds of LA was 4 times higher in the women who underwent the former mode of delivery. In those women who subsequently have a prolapse in later life and require a surgical repair, there has been much recent interest in what type of surgical repair will result in less surgical complications and recurrence of prolapse requiring a repeat operation. On pages 656–663, Fritel and colleagues reported data from a French registry on 19 urogynaecological surgical units. This study compared the rate of severe complications (Clavien-Dindo grade ≥3) and recurrence of pelvic organ prolapse requiring repeat surgery for the three most common type of repair procedures: native vaginal tissue repair, transvaginal mesh placements and laparoscopic sacropexies with mesh. With native vaginal tissue repair as the referent group, the risk of serious operative complications was higher with both transvaginal mesh placements and laparoscopic sacropexies. Interestingly, any concomitant total hysterectomy also independently increases the risk of a serious surgical complication further. However, the risk of recurrence of prolapse requiring repeat surgery is both lower with transvaginal mesh placements and laparoscopic sacropexies when compared to native vaginal tissue repair. This information on the efficacy balanced against surgical risk would be useful to patients in their clinical decision making and providing informed consent for their treatment. Having a vaginal delivery is known to increase the likelihood of subsequent stress urinary incontinence. The mid-urethral mesh sling procedures were popular methods of treating stress urinary incontinence but more recently, these procedure has been curtailed in some countries due to the concerns on the long term safety of the mesh implants. Another concern with mesh implants is the possibility that these implants may increase the risk of developing chronic systemic conditions such as autoimmune disease, chronic pain and fatigue. On pages 664–670, Muller reported the follow up data on women who underwent urinary incontinence surgery for the first time in England from 2003 till 2013 without a previous diagnosis of any such condition. The follow up outcome of women who underwent mid-urethral mesh sling procedures (n = 88 947) were compared to those who had bladder neck surgery without mesh implants (n = 3389). The procedures with mesh implants for urinary incontinence included tension-free vaginal tape or trans-obturator tape insertion whereas the operations without mesh insertion were colposuspension and native tissue sling procedures. This study showed that the risk of developing an autoimmune disease, fibromyalgia or myalgic encephalomyelitis was similar between the two groups of operations and this result remained unchanged with a sensitivity analysis using patients with autoimmune diseases alone. The findings from this study should provide some reassurance to those women who chose to have a mesh implant for their stress urinary incontinence surgery.

International Journal of Gynecology & ObstetricsEarly View CORRESPONDENCE Letter to the Editor: Research and consensus is required concerning integrity of randomized clinical trials Khalid S. Khan, Corresponding Author Khalid S. Khan profkkhan@gmail.com orcid.org/0000-0001-5084-7312 University of Granada, Granada, Spain Correspondence Khalid S. Khan, School of Medicine, University of Granada, 18016, Spain. Email: profkkhan@gmail.comSearch for more papers by this authorPatrick F. W. Chien, Patrick F. W. Chien orcid.org/0000-0002-5998-9592 RCSI & UCD Malaysia Campus, George Town, MalaysiaSearch for more papers by this author Khalid S. Khan, Corresponding Author Khalid S. Khan profkkhan@gmail.com orcid.org/0000-0001-5084-7312 University of Granada, Granada, Spain Correspondence Khalid S. Khan, School of Medicine, University of Granada, 18016, Spain. Email: profkkhan@gmail.comSearch for more papers by this authorPatrick F. W. Chien, Patrick F. W. Chien orcid.org/0000-0002-5998-9592 RCSI & UCD Malaysia Campus, George Town, MalaysiaSearch for more papers by this author First published: 28 August 2022 https://doi.org/10.1002/ijgo.14394Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Early ViewOnline Version of Record before inclusion in an issue RelatedInformation

Deputy Editor‐in‐Chief, Dr Patrick Chien, discusses how top articles from this issue in an audio podcast available at: https://soundcloud.com/bjog/april‐editors‐choice‐2021 .

Abstract Background Endometriosis (where endometrial-like tissue is found outside the uterus) affects ~ 176 million women worldwide and can lead to debilitating pelvic pain. Three subtypes of endometriosis exist, with ~ 80% of women having superficial peritoneal endometriosis (SPE). Endometriosis is diagnosed by laparoscopy and, if SPE is found, gynaecologists usually remove it surgically. However, many women get limited pain relief from surgical removal of SPE. We plan to undertake a future large trial where women who have only SPE found at initial laparoscopy are randomly allocated to have surgical removal (excision or ablation) of SPE, or not. Ultimately, we want to determine whether surgical removal improves overall symptoms and quality of life, or whether surgery is of no benefit, exacerbates symptoms, or even causes harm. The primary objective of this feasibility study is to determine what proportion of women with suspected SPE undergoing diagnostic laparoscopy will agree to randomisation. The secondary objectives are to determine if there are differences in key prognostic parameters between eligible women that agree to be randomised and those that decline; how many women having laparoscopy for investigation of chronic pelvic pain are eligible for the trial; the range of treatment effects and variability in outcomes and the most acceptable methods of recruitment, randomisation and assessment tools. Methods We will recruit up to 90 women with suspected SPE undergoing diagnostic laparoscopy over a 9-month recruitment period in four Scottish hospitals and randomise them 1:1 to either diagnostic laparoscopy alone (with a sham port to achieve blinding of the allocation) or surgical removal of endometriosis. Baseline characteristics, e.g. age, index of social deprivation, ethnicity, and intensity/duration of pain will be collected. Participants will be followed up by online questionnaires assessing pain, physical and emotional function at baseline, 3 months, 6 months and 12 months. Discussion Recruitment to a randomised controlled trial to assess the effectiveness of surgery for endometriosis may be challenging because of preconceived ideas about treatment success amongst patients and clinicians. We have designed this study to assess feasibility of recruitment and to inform the design of our future definitive trial. Trial registration ClincicalTrials.gov, NCT04081532 Status Recruiting

Deputy Editor‐in‐Chief, Dr Patrick Chien, discusses his top articles from this issue in an audio podcast available at: https://soundcloud.com/bjog/january‐editors‐choice‐2021 .

Deputy Editor‐in‐Chief, Dr Patrick Chien, discusses the latest thinking in women's health and highlights articles from this issue in an audio podcast available at: https://soundcloud.com/bjog/july-editorial-2020

Deputy Editor‐in‐Chief, Dr Patrick Chien, discusses the latest thinking in women’s health and highlights articles from this issue in an audio podcast available at: https://soundcloud.com/bjog/april-editorial-2020