Prospective multicentre cohort study of patient-reported outcomes and complications following major abdominal neoplastic surgery (PATRONUS) – study protocol for a CHIR-Net student-initiated German medical audit study (CHIR-Net SIGMA study)
Abstract Background One of the most important aspects of designing a clinical trial is selecting appropriate outcomes. Patient-reported outcomes (PROs) can provide a personal assessment of the burden and impact of a malignant disease and its treatment. PROs comprise a wide range of outcomes includin...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2018-10-01
|
| Series: | BMC Surgery |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12893-018-0422-3 |
| _version_ | 1811208244008321024 |
|---|---|
| author | Christoph A. Fink Mirco Friedrich Pia-Elena Frey Lukas Rädeker Alexander Leuck Thomas Bruckner Manuel Feisst Solveig Tenckhoff Christina Klose Colette Dörr-Harim Jens Neudecker André L. Mihaljevic |
| author_facet | Christoph A. Fink Mirco Friedrich Pia-Elena Frey Lukas Rädeker Alexander Leuck Thomas Bruckner Manuel Feisst Solveig Tenckhoff Christina Klose Colette Dörr-Harim Jens Neudecker André L. Mihaljevic |
| author_sort | Christoph A. Fink |
| collection | DOAJ |
| description | Abstract Background One of the most important aspects of designing a clinical trial is selecting appropriate outcomes. Patient-reported outcomes (PROs) can provide a personal assessment of the burden and impact of a malignant disease and its treatment. PROs comprise a wide range of outcomes including basic clinical symptom scores and complex metrics such as health-related quality of life (HRQoL). There is limited data on how postoperative complications following cancer surgery affect symptoms and HRQoL. For this reason the primary aim of the PATRONUS study is to investigate how perioperative complications affect cancer-related symptoms and HRQoL in patients undergoing abdominal cancer surgery. The PATRONUS study is designed and will be initiated and conducted by medical students under the direct supervision of clinician scientists based on the concept of inquiry-based learning. Methods PATRONUS is a non-interventional prospective multicentre cohort study. Patients undergoing elective oncological abdominal surgery will be recruited at regional centres of the clinical network of the German Surgical Society (CHIR-Net) and associated hospitals. A core set of 12 cancer associated symptoms will be assessed via the PRO version of the Common Terminology Criteria for Adverse Events. The cancer-specific HRQoL will be measured via the computerised adaptive testing version of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30. PROs will be measured eight times over a period of six months. The short-term clinical outcome measure is the rate of postoperative complications (grade II to V) within 30 days according to the Clavien-Dindo classification. The long-term clinical outcome is overall survival within six months postoperative. Discussion PATRONUS will provide essential insights into the patients’ assessment of their well-being and quality of life in direct relation to clinical outcome parameters following abdominal cancer surgery. Furthermore, PATRONUS will investigate the feasibility of multicentre student-led clinical research. Trial registration German Clinical Trials Register: DRKS00013035 (registered on October 26, 2017). Universal Trial Number (UTN): U1111–1202-8863. |
| first_indexed | 2024-04-12T04:18:41Z |
| format | Article |
| id | doaj.art-421bc4ba1fb742fb82cd74bd5686f805 |
| institution | Directory Open Access Journal |
| issn | 1471-2482 |
| language | English |
| last_indexed | 2024-04-12T04:18:41Z |
| publishDate | 2018-10-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Surgery |
| spelling | doaj.art-421bc4ba1fb742fb82cd74bd5686f8052022-12-22T03:48:19ZengBMCBMC Surgery1471-24822018-10-0118111110.1186/s12893-018-0422-3Prospective multicentre cohort study of patient-reported outcomes and complications following major abdominal neoplastic surgery (PATRONUS) – study protocol for a CHIR-Net student-initiated German medical audit study (CHIR-Net SIGMA study)Christoph A. Fink0Mirco Friedrich1Pia-Elena Frey2Lukas Rädeker3Alexander Leuck4Thomas Bruckner5Manuel Feisst6Solveig Tenckhoff7Christina Klose8Colette Dörr-Harim9Jens Neudecker10André L. Mihaljevic11University of Heidelberg, Faculty of MedicineUniversity of Heidelberg, Faculty of MedicineUniversity of Heidelberg, Faculty of MedicineUniversity of Heidelberg, Faculty of MedicineUniversity of Heidelberg, Faculty of MedicineInstitute of Medical Biometry and Informatics, University of HeidelbergInstitute of Medical Biometry and Informatics, University of HeidelbergCHIR-Net Coordination Centre at the Study Centre of the German Surgical Society (SDGC), University Hospital HeidelbergInstitute of Medical Biometry and Informatics, University of HeidelbergDepartment of General, Visceral and Transplantation Surgery, University Hospital HeidelbergDepartment of Surgery, Campus Virchow-Klinikum, Charité, Universitätsmedizin BerlinDepartment of General, Visceral and Transplantation Surgery, University Hospital HeidelbergAbstract Background One of the most important aspects of designing a clinical trial is selecting appropriate outcomes. Patient-reported outcomes (PROs) can provide a personal assessment of the burden and impact of a malignant disease and its treatment. PROs comprise a wide range of outcomes including basic clinical symptom scores and complex metrics such as health-related quality of life (HRQoL). There is limited data on how postoperative complications following cancer surgery affect symptoms and HRQoL. For this reason the primary aim of the PATRONUS study is to investigate how perioperative complications affect cancer-related symptoms and HRQoL in patients undergoing abdominal cancer surgery. The PATRONUS study is designed and will be initiated and conducted by medical students under the direct supervision of clinician scientists based on the concept of inquiry-based learning. Methods PATRONUS is a non-interventional prospective multicentre cohort study. Patients undergoing elective oncological abdominal surgery will be recruited at regional centres of the clinical network of the German Surgical Society (CHIR-Net) and associated hospitals. A core set of 12 cancer associated symptoms will be assessed via the PRO version of the Common Terminology Criteria for Adverse Events. The cancer-specific HRQoL will be measured via the computerised adaptive testing version of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30. PROs will be measured eight times over a period of six months. The short-term clinical outcome measure is the rate of postoperative complications (grade II to V) within 30 days according to the Clavien-Dindo classification. The long-term clinical outcome is overall survival within six months postoperative. Discussion PATRONUS will provide essential insights into the patients’ assessment of their well-being and quality of life in direct relation to clinical outcome parameters following abdominal cancer surgery. Furthermore, PATRONUS will investigate the feasibility of multicentre student-led clinical research. Trial registration German Clinical Trials Register: DRKS00013035 (registered on October 26, 2017). Universal Trial Number (UTN): U1111–1202-8863.http://link.springer.com/article/10.1186/s12893-018-0422-3Patient-reported outcome measuresQuality of lifeNeoplasmsPostoperative complicationsGeneral surgeryDigestive system surgical procedures |
| spellingShingle | Christoph A. Fink Mirco Friedrich Pia-Elena Frey Lukas Rädeker Alexander Leuck Thomas Bruckner Manuel Feisst Solveig Tenckhoff Christina Klose Colette Dörr-Harim Jens Neudecker André L. Mihaljevic Prospective multicentre cohort study of patient-reported outcomes and complications following major abdominal neoplastic surgery (PATRONUS) – study protocol for a CHIR-Net student-initiated German medical audit study (CHIR-Net SIGMA study) BMC Surgery Patient-reported outcome measures Quality of life Neoplasms Postoperative complications General surgery Digestive system surgical procedures |
| title | Prospective multicentre cohort study of patient-reported outcomes and complications following major abdominal neoplastic surgery (PATRONUS) – study protocol for a CHIR-Net student-initiated German medical audit study (CHIR-Net SIGMA study) |
| title_full | Prospective multicentre cohort study of patient-reported outcomes and complications following major abdominal neoplastic surgery (PATRONUS) – study protocol for a CHIR-Net student-initiated German medical audit study (CHIR-Net SIGMA study) |
| title_fullStr | Prospective multicentre cohort study of patient-reported outcomes and complications following major abdominal neoplastic surgery (PATRONUS) – study protocol for a CHIR-Net student-initiated German medical audit study (CHIR-Net SIGMA study) |
| title_full_unstemmed | Prospective multicentre cohort study of patient-reported outcomes and complications following major abdominal neoplastic surgery (PATRONUS) – study protocol for a CHIR-Net student-initiated German medical audit study (CHIR-Net SIGMA study) |
| title_short | Prospective multicentre cohort study of patient-reported outcomes and complications following major abdominal neoplastic surgery (PATRONUS) – study protocol for a CHIR-Net student-initiated German medical audit study (CHIR-Net SIGMA study) |
| title_sort | prospective multicentre cohort study of patient reported outcomes and complications following major abdominal neoplastic surgery patronus study protocol for a chir net student initiated german medical audit study chir net sigma study |
| topic | Patient-reported outcome measures Quality of life Neoplasms Postoperative complications General surgery Digestive system surgical procedures |
| url | http://link.springer.com/article/10.1186/s12893-018-0422-3 |
| work_keys_str_mv | AT christophafink prospectivemulticentrecohortstudyofpatientreportedoutcomesandcomplicationsfollowingmajorabdominalneoplasticsurgerypatronusstudyprotocolforachirnetstudentinitiatedgermanmedicalauditstudychirnetsigmastudy AT mircofriedrich prospectivemulticentrecohortstudyofpatientreportedoutcomesandcomplicationsfollowingmajorabdominalneoplasticsurgerypatronusstudyprotocolforachirnetstudentinitiatedgermanmedicalauditstudychirnetsigmastudy AT piaelenafrey prospectivemulticentrecohortstudyofpatientreportedoutcomesandcomplicationsfollowingmajorabdominalneoplasticsurgerypatronusstudyprotocolforachirnetstudentinitiatedgermanmedicalauditstudychirnetsigmastudy AT lukasradeker prospectivemulticentrecohortstudyofpatientreportedoutcomesandcomplicationsfollowingmajorabdominalneoplasticsurgerypatronusstudyprotocolforachirnetstudentinitiatedgermanmedicalauditstudychirnetsigmastudy AT alexanderleuck prospectivemulticentrecohortstudyofpatientreportedoutcomesandcomplicationsfollowingmajorabdominalneoplasticsurgerypatronusstudyprotocolforachirnetstudentinitiatedgermanmedicalauditstudychirnetsigmastudy AT thomasbruckner prospectivemulticentrecohortstudyofpatientreportedoutcomesandcomplicationsfollowingmajorabdominalneoplasticsurgerypatronusstudyprotocolforachirnetstudentinitiatedgermanmedicalauditstudychirnetsigmastudy AT manuelfeisst prospectivemulticentrecohortstudyofpatientreportedoutcomesandcomplicationsfollowingmajorabdominalneoplasticsurgerypatronusstudyprotocolforachirnetstudentinitiatedgermanmedicalauditstudychirnetsigmastudy AT solveigtenckhoff prospectivemulticentrecohortstudyofpatientreportedoutcomesandcomplicationsfollowingmajorabdominalneoplasticsurgerypatronusstudyprotocolforachirnetstudentinitiatedgermanmedicalauditstudychirnetsigmastudy AT christinaklose prospectivemulticentrecohortstudyofpatientreportedoutcomesandcomplicationsfollowingmajorabdominalneoplasticsurgerypatronusstudyprotocolforachirnetstudentinitiatedgermanmedicalauditstudychirnetsigmastudy AT colettedorrharim prospectivemulticentrecohortstudyofpatientreportedoutcomesandcomplicationsfollowingmajorabdominalneoplasticsurgerypatronusstudyprotocolforachirnetstudentinitiatedgermanmedicalauditstudychirnetsigmastudy AT jensneudecker prospectivemulticentrecohortstudyofpatientreportedoutcomesandcomplicationsfollowingmajorabdominalneoplasticsurgerypatronusstudyprotocolforachirnetstudentinitiatedgermanmedicalauditstudychirnetsigmastudy AT andrelmihaljevic prospectivemulticentrecohortstudyofpatientreportedoutcomesandcomplicationsfollowingmajorabdominalneoplasticsurgerypatronusstudyprotocolforachirnetstudentinitiatedgermanmedicalauditstudychirnetsigmastudy |