Development and feasibility of a sex- and gender-sensitive primary care intervention for patients with chronic non-cancer pain receiving long-term opioid therapy (GESCO): a study protocol

Abstract Background Chronic non-cancer pain (CNCP) is a common condition worldwide. The disease burden is influenced not only by pain itself, but also by psychiatric co-morbidities, which aggravate symptoms, generally negatively influence therapies, and may thereby lead to frustration, resignation,...

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Main Authors: Christine Kersting, Johannes Just, Alexandra Piotrowski, Alexandra Schmidt, Neele Kufeld, Rebecca Bisplinghoff, Michaela Maas, Veronika Bencheva, Jordan Preuß, Birgitt Wiese, Klaus Weckbecker, Achim Mortsiefer, Petra Thürmann, on behalf of the GESCO study group
Format: Article
Language:English
Published: BMC 2024-11-01
Series:Pilot and Feasibility Studies
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Online Access:https://doi.org/10.1186/s40814-024-01564-7
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author Christine Kersting
Johannes Just
Alexandra Piotrowski
Alexandra Schmidt
Neele Kufeld
Rebecca Bisplinghoff
Michaela Maas
Veronika Bencheva
Jordan Preuß
Birgitt Wiese
Klaus Weckbecker
Achim Mortsiefer
Petra Thürmann
on behalf of the GESCO study group
author_facet Christine Kersting
Johannes Just
Alexandra Piotrowski
Alexandra Schmidt
Neele Kufeld
Rebecca Bisplinghoff
Michaela Maas
Veronika Bencheva
Jordan Preuß
Birgitt Wiese
Klaus Weckbecker
Achim Mortsiefer
Petra Thürmann
on behalf of the GESCO study group
author_sort Christine Kersting
collection DOAJ
description Abstract Background Chronic non-cancer pain (CNCP) is a common condition worldwide. The disease burden is influenced not only by pain itself, but also by psychiatric co-morbidities, which aggravate symptoms, generally negatively influence therapies, and may thereby lead to frustration, resignation, or withdrawal. A growing body of evidence suggests that sex and gender aspects influence CNCP management as the experience of pain, the emotions associated with it, and the expression of pain may differ between women and men. In addition, doctor-patient communication is known to be influenced by gender stereotypes. Despite there being evidence on such differences, current guidelines do not consider sex- and gender-sensitive approaches. In order to examine how to adequately address the diversity of the experience and processing of pain in patients of differing sex and gender, the GESCO study aims at developing and pilot testing a sex- and gender-sensitive intervention for patients with CNCP receiving long-term opioid therapy (LTOT) in primary care. Methods The development process is designed in accordance with the first two phases of the UK Medical Research Council. Phase I will iteratively explore, develop, and pilot the intervention’s modules using literature searches, interviews, and workshops involving stakeholders and experts. Phase II will pilot-test the novel intervention in a sample of 40 patients with CNCP under LTOT from ten general practices using an effectiveness-implementation hybrid design including a mixed-methods process evaluation focusing on implementation strategy criteria and a single-arm, pre-post comparison to determine preliminary effects in preparation for a larger effectiveness trial. The intervention will combine in-person educational sessions for general practitioners and tools to be used in patient care. Discussion The intervention aims to improve CNCP management in primary care by empowering practitioners to reflect on their attitudes towards pain and stereotypes. Besides sex and gender aspects, awareness of other factors that might affect the care process, such as age, social conditions, or culture, is also promoted. The intention is to develop a comprehensive care concept for CNCP that considers aspects relevant for sex- and gender-sensitive care which are transferrable to other health care fields as well. Trial registration German Clinical Trial Register DRKS00029980.
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spelling doaj-art-1a872e24e98f46f7b1cfe63145fc18e72025-08-20T02:18:11ZengBMCPilot and Feasibility Studies2055-57842024-11-0110111210.1186/s40814-024-01564-7Development and feasibility of a sex- and gender-sensitive primary care intervention for patients with chronic non-cancer pain receiving long-term opioid therapy (GESCO): a study protocolChristine Kersting0Johannes Just1Alexandra Piotrowski2Alexandra Schmidt3Neele Kufeld4Rebecca Bisplinghoff5Michaela Maas6Veronika Bencheva7Jordan Preuß8Birgitt Wiese9Klaus Weckbecker10Achim Mortsiefer11Petra Thürmann12on behalf of the GESCO study groupChair of General Practice II and Patient-Centredness in Primary Care, Institute of General Practice and Primary Care, Faculty of Health, Witten/Herdecke UniversityChair of General Practice II and Patient-Centredness in Primary Care, Institute of General Practice and Primary Care, Faculty of Health, Witten/Herdecke UniversityChair of General Practice II and Patient-Centredness in Primary Care, Institute of General Practice and Primary Care, Faculty of Health, Witten/Herdecke UniversityChair of General Practice II and Patient-Centredness in Primary Care, Institute of General Practice and Primary Care, Faculty of Health, Witten/Herdecke UniversityChair of General Practice I and Interprofessional Care, Institute of General Practice and Primary Care, Faculty of Health, Witten/Herdecke UniversityChair of General Practice I and Interprofessional Care, Institute of General Practice and Primary Care, Faculty of Health, Witten/Herdecke UniversityChair of General Practice II and Patient-Centredness in Primary Care, Institute of General Practice and Primary Care, Faculty of Health, Witten/Herdecke UniversityChair of Clinical Pharmacology, Faculty of Health, Witten/Herdecke UniversityChair of Clinical Pharmacology, Faculty of Health, Witten/Herdecke UniversityIT Services Applications, Science & Laboratory, MHH Information Technology, Hannover Medical SchoolChair of General Practice I and Interprofessional Care, Institute of General Practice and Primary Care, Faculty of Health, Witten/Herdecke UniversityChair of General Practice II and Patient-Centredness in Primary Care, Institute of General Practice and Primary Care, Faculty of Health, Witten/Herdecke UniversityChair of Clinical Pharmacology, Faculty of Health, Witten/Herdecke UniversityAbstract Background Chronic non-cancer pain (CNCP) is a common condition worldwide. The disease burden is influenced not only by pain itself, but also by psychiatric co-morbidities, which aggravate symptoms, generally negatively influence therapies, and may thereby lead to frustration, resignation, or withdrawal. A growing body of evidence suggests that sex and gender aspects influence CNCP management as the experience of pain, the emotions associated with it, and the expression of pain may differ between women and men. In addition, doctor-patient communication is known to be influenced by gender stereotypes. Despite there being evidence on such differences, current guidelines do not consider sex- and gender-sensitive approaches. In order to examine how to adequately address the diversity of the experience and processing of pain in patients of differing sex and gender, the GESCO study aims at developing and pilot testing a sex- and gender-sensitive intervention for patients with CNCP receiving long-term opioid therapy (LTOT) in primary care. Methods The development process is designed in accordance with the first two phases of the UK Medical Research Council. Phase I will iteratively explore, develop, and pilot the intervention’s modules using literature searches, interviews, and workshops involving stakeholders and experts. Phase II will pilot-test the novel intervention in a sample of 40 patients with CNCP under LTOT from ten general practices using an effectiveness-implementation hybrid design including a mixed-methods process evaluation focusing on implementation strategy criteria and a single-arm, pre-post comparison to determine preliminary effects in preparation for a larger effectiveness trial. The intervention will combine in-person educational sessions for general practitioners and tools to be used in patient care. Discussion The intervention aims to improve CNCP management in primary care by empowering practitioners to reflect on their attitudes towards pain and stereotypes. Besides sex and gender aspects, awareness of other factors that might affect the care process, such as age, social conditions, or culture, is also promoted. The intention is to develop a comprehensive care concept for CNCP that considers aspects relevant for sex- and gender-sensitive care which are transferrable to other health care fields as well. Trial registration German Clinical Trial Register DRKS00029980.https://doi.org/10.1186/s40814-024-01564-7Chronic painOpioidsGender roleSexPrimary care
spellingShingle Christine Kersting
Johannes Just
Alexandra Piotrowski
Alexandra Schmidt
Neele Kufeld
Rebecca Bisplinghoff
Michaela Maas
Veronika Bencheva
Jordan Preuß
Birgitt Wiese
Klaus Weckbecker
Achim Mortsiefer
Petra Thürmann
on behalf of the GESCO study group
Development and feasibility of a sex- and gender-sensitive primary care intervention for patients with chronic non-cancer pain receiving long-term opioid therapy (GESCO): a study protocol
Pilot and Feasibility Studies
Chronic pain
Opioids
Gender role
Sex
Primary care
title Development and feasibility of a sex- and gender-sensitive primary care intervention for patients with chronic non-cancer pain receiving long-term opioid therapy (GESCO): a study protocol
title_full Development and feasibility of a sex- and gender-sensitive primary care intervention for patients with chronic non-cancer pain receiving long-term opioid therapy (GESCO): a study protocol
title_fullStr Development and feasibility of a sex- and gender-sensitive primary care intervention for patients with chronic non-cancer pain receiving long-term opioid therapy (GESCO): a study protocol
title_full_unstemmed Development and feasibility of a sex- and gender-sensitive primary care intervention for patients with chronic non-cancer pain receiving long-term opioid therapy (GESCO): a study protocol
title_short Development and feasibility of a sex- and gender-sensitive primary care intervention for patients with chronic non-cancer pain receiving long-term opioid therapy (GESCO): a study protocol
title_sort development and feasibility of a sex and gender sensitive primary care intervention for patients with chronic non cancer pain receiving long term opioid therapy gesco a study protocol
topic Chronic pain
Opioids
Gender role
Sex
Primary care
url https://doi.org/10.1186/s40814-024-01564-7
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