Evidence map›Paper›PMID 41033777›Full record

ArticleBMJ open2025

Co-designing, evaluating and implementing online supportive care for endometriosis in Australia: study protocol for the hybrid type 1 effectiveness, cost-effectiveness and implementation randomised controlled trial of the CodeEndo program.

Antonina Mikocka-Walus, Colette Naude, Yao Coitinho Biurra, Lily Blake, Jessica Bowring, Samantha De Araugo, Anna Bassili, Shannon K Bennetts, Alison M Hutchinson, Cecilia Hoi Man Ng and 31 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

41 authors.

Antonina Mikocka-Walus *School of Psychology, Deakin University, Burwood, Victoria, Australia antonina.mikockawalus@deakin.edu.au.ORCID http://orcid.org/0000-0003-4864-3956
Colette Naude *School of Psychology, Deakin University, Burwood, Victoria, Australia.ORCID http://orcid.org/0000-0002-7650-485X
Yao Coitinho BiurraSchool of Psychology, Deakin University, Burwood, Victoria, Australia.ORCID http://orcid.org/0009-0001-2300-4376
Lily BlakeSchool of Psychology, Deakin University, Burwood, Victoria, Australia.ORCID http://orcid.org/0009-0006-0837-8851
Jessica BowringSchool of Psychology, Deakin University, Burwood, Victoria, Australia.
Samantha De AraugoSchool of Psychology, Deakin University, Burwood, Victoria, Australia.
Anna BassiliSchool of Psychology, Deakin University, Burwood, Victoria, Australia.
Shannon K BennettsSchool of Psychology, Deakin University, Burwood, Victoria, Australia.ORCID http://orcid.org/0000-0003-3758-0398
Alison M HutchinsonSchool of Nursing and Midwifery & Institute for Health Transformation, Deakin University, Burwood, Victoria, Australia.ORCID http://orcid.org/0000-0001-5065-2726
Cecilia Hoi Man NgNational Endometriosis Clinical and Scientific Trials (NECST) Network, University of New South Wales, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0002-8637-9861
Chatpakorn PrasertsungFaculty of Health, Deakin University, Burwood, Victoria, Australia.
David SkvarcSchool of Psychology, Deakin University, Burwood, Victoria, Australia.
Drew ArasAcademic Health Science Centre, Western Alliance, Warrnambool, Victoria, Australia.
Donna CicciaEndometriosis Australia, Sydney, New South Wales, Australia.
Eric OFaculty of Health, Deakin University, Burwood, Victoria, Australia.
Felice JackaInstitute for Mental and Physical Health and Clinical Translation (IMPACT), Deakin University, Geelong, Victoria, Australia.
Heidi M StaudacherInstitute for Mental and Physical Health and Clinical Translation (IMPACT), Deakin University, Geelong, Victoria, Australia.
Jane VarneyDepartment of Gastroenterology, Monash University, Melbourne, Victoria, Australia.ORCID http://orcid.org/0000-0001-7820-057X
Jason AbbottNational Endometriosis Clinical and Scientific Trials (NECST) Network, University of New South Wales, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0002-4406-3121
Jill HarrisKyo Yoga & Healing, Ocean Grove, Victoria, Australia.
Jim TsaltasEpworth HealthCare, Richmond, Victoria, Australia.
Justin SinclairNICM Health Research Institute, Western Sydney University, Penrith South, New South Wales, Australia.
Kate TysonEpworth HealthCare, Richmond, Victoria, Australia.
Katherine StanleyEndoHelp Foundation, Melbourne, Victoria, Australia.
Lahiru RussellFaculty of Health, Deakin University, Burwood, Victoria, Australia.ORCID http://orcid.org/0000-0002-3806-0020
Leesa Van NiekerkNational Endometriosis Clinical and Scientific Trials (NECST) Network, University of New South Wales, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0002-6641-5888
Liliana OrellanaFaculty of Health, Deakin University, Burwood, Victoria, Australia.ORCID http://orcid.org/0000-0003-3736-4337
Madeleine DoberRoyal Melbourne Hospital, Melbourne, Victoria, Australia.
Marilla L DruittSchool of Medicine, Deakin University, Geelong, Victoria, Australia.
Melissa O'SheaSchool of Psychology, Deakin University, Burwood, Victoria, Australia.
Mike ArmourNational Endometriosis Clinical and Scientific Trials (NECST) Network, University of New South Wales, Sydney, New South Wales, Australia.ORCID http://orcid.org/0000-0001-7539-9851
Nikki McCaffreySchool of Health and Social Development, Deakin University, Burwood, Victoria, Australia.ORCID http://orcid.org/0000-0003-3684-3723
Natalie AndersonBellarine Pelvic Health, Ocean Grove, Victoria, Australia.
Patricia M LivingstonFaculty of Health, Deakin University, Burwood, Victoria, Australia.ORCID http://orcid.org/0000-0001-6616-3839
Rebecca O'HaraCollege of Medicine and Public Health, Flinders University, Adelaide, South Australia, Australia.
Sarah WhiteJean Hailes for Women's Health, Melbourne, Victoria, Australia.
Simon R KnowlesDepartment of Psychological Sciences, Swinburne University of Technology, Hawthorn, Victoria, Australia.ORCID http://orcid.org/0000-0001-8000-1000
Suiyin CheahSchool of Psychology, Deakin University, Burwood, Victoria, Australia.
Susan ChestermanSchool of Psychology, Deakin University, Burwood, Victoria, Australia.
Tiffany BrooksAdelaide Medical School, University of Adelaide, Adelaide, South Australia, Australia.
Subhadra EvansSchool of Psychology, Deakin University, Burwood, Victoria, Australia.ORCID http://orcid.org/0000-0002-1898-0030

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionEndometriosis is a chronic condition affecting up to 11% of people presumed female at birth by the age of 44 years, characterised by the growth of tissue similar to the lining of the uterus on other organs. Endometriosis significantly impacts health-related quality of life (HRQoL) and imposes a substantial burden on both individuals and the healthcare system. International guidelines recommend the interdisciplinary management of endometriosis due to its significant biopsychosocial burden; however, research aimed at exploring psychological approaches for endometriosis is limited. This trial aims to evaluate the effectiveness of CodeEndo, an online co-designed interdisciplinary supportive care program, compared with a waitlist control (WLC), on HRQoL and biopsychosocial outcomes in people with a diagnosis of endometriosis. METHODS AND ANALYSIS: A hybrid type 1 effectiveness and implementation randomised controlled trial (RCT) will be conducted. Eligible participants will be randomly allocated to either the CodeEndo program (n=176) or WLC group (n=176) for 8 weeks. The primary outcome will be HRQoL, and secondary outcomes will include psychological symptoms (anxiety, depression, stress), self-efficacy, menstrual, bladder and gastrointestinal symptoms, pain, fatigue, sleep, exercise, diet, symptom bothersomeness and physical and psychological well-being, measured at 8 weeks post-randomisation (T2) and 6-month follow-up (T3). Cost-effectiveness will also be examined. Longitudinal qualitative individual interviews (up to n=40) will be conducted with participants who complete the CodeEndo program to explore benefits, barriers and facilitators of ongoing use. Additionally, the CodeEndo program will undergo evaluation by a group of endometriosis healthcare providers, who will assess potential barriers and facilitators to its real-world implementation. Various process evaluation strategies will also be measured to inform future implementation. Data analyses will incorporate mixed-effects regression models on an intention-to-treat basis, cost-consequences and cost-utility, dietary and qualitative thematic analysis. ETHICS AND DISSEMINATION: This protocol received ethics approval from Deakin University Research Ethics Committee (DUREC Ref: 2024-157). Dissemination is expected to include peer-reviewed journal articles, reports, conference presentations as well as websites or social media platforms of relevant chronic pain organisations. Participants will be sent a summary of trial results. TRIAL REGISTRATION NUMBER: ACTRN12623000598684p.

Indexed as

EndometriosisQuality of LifeAdultAustraliaCost-Benefit AnalysisCost-Effectiveness AnalysisFemaleHumansRandomized Controlled Trials as Topicdigital technologygynaecologypsychosocial interventionquality of liferandomized controlled trialsubfertility

Identifiers

PMID41033777
PMCPMC12496073

What OpenQuestion holds

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LicenceCC BY-NC
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.