BJOG mini commentary on study BJOG-21-1829TITLE: Putting patients at the centre of pain managementAlexandra Wojtaszewskaa, Arvind Vashishtb, Martin Hirschc,daWatford General Hospital, Watford, United KingdombInstitute for Women’s Health, University College London, London, United Kingdom.cThe John Radcliffe Hospital, Oxford University Hospitals, Oxford, United Kingdom.dOxford Endometriosis CaRe Centre, Nuffield Department of Women’s & Reproductive Health, University of Oxford, Oxford, United Kingdom.Conflict of interest : noneFinancial support received : none

BJOG-21-0667.R1: Our Guidelines Are Not Good EnoughAlexandra Wojtaszewskaa, Martin HirschbaWatford General Hospital, Watford, United KingdombOxford Endometriosis CaRe Centre, Nuffield Department of Women’s & Reproductive Health, University of Oxford, Oxford, United Kingdom.Declarations of interest: noneFinancial support received: noneBJOG-21-0667.R1: Our Guidelines Are Not Good EnoughAmoah et al. highlight the lack of high-quality fibroid guidelines in their appraisal of uterine fibroid management guidelines. This paper sheds light on the association between low quality research informing low quality clinical guidance. The authors included nine national and international guidelines on fibroid management in their analysis and screened 189 recommendations and statements made across these documents. Guideline quality was assessed using the AGREE-II instrument and no high-quality guidelines were identified. No guidelines reported involvement of patients with fibroids in their development and across all guidelines consensus was reached on only three (1.6%) of 189 statements. The authors explored the quality of evidence base behind the recommendations concluding that 25.3% were developed from good-quality evidence while 27.7% were based on lowest quality evidence (expert opinion or clinical consensus).These findings of poor quality and high discrepancy between guideline recommendations for fibroids are not unique to the condition. Other systematic reviews found similar results when analysing guidelines for management of endometriosis (Hirsch et al. BJOG 2018;125:556-564) and uncomplicated birth (Zhao et al. BJOG 2020;127:789-797).When writing or updating guidelines, locally or nationally, authors must consider how to ensure highest possible quality. There are several validated tools for quality assessment available (including AGREE II, ADAPTE, AMTAR and INAHTA and iCAHE Guideline Quality Checklists).The landscape for guideline development is changing. The rapid development of novel technologies requires a prompt response and evaluation of not only efficacy but the wider environmental impact and health economic assessment. The current system of laborious static single point assessments of evidence-based medicine producing clinical guidelines every few years is no longer appropriate. The National Institute for Health and Care Excellence (NICE) acknowledge the need for proactive, fluid, and flexible processes to enable the digitalisation of health systems to inform practice through real-world evidence (NICE 2021, The NICE Strategy 2021 to 2026 ). Guidelines will respond in a dynamic manner to population changes using contemporaneous evaluation of clinical data available from digitalised care systems. We look forward to integrated care systems delivering population-based healthcare on a regional basis. Guidelines will extend across health, social care, and public health focusing on health prevention, reducing health inequality, and delivering those interventions that offer the greatest benefit.As highlighted by this study, the development of guidelines without standardised methods is commonplace. This may lead to exclusion of beneficial treatments, a paucity of comparable recommendations, recommendations based on poor quality data, and poor patient outcomes. Looking to the future we do not see the need to fix a fractured guideline development system but rather build a new one. We must adapt and adopt the integration of digitalised real-world health system data to facilitate rapid and robust clinical decisions on a regional or national basis.

Sir,We read with great interest the recent study by Misra et al.evaluating different surgical interventions for the treatment of pain associated with endometriosis.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.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.2Reflecting 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.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.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.