PMID- 33888530 OWN - NLM STAT- MEDLINE DCOM- 20210520 LR - 20240429 IS - 2044-6055 (Electronic) IS - 2044-6055 (Linking) VI - 11 IP - 4 DP - 2021 Apr 22 TI - Swiss-wide multicentre evaluation and prediction of core outcomes in arthroscopic rotator cuff repair: protocol for the ARCR_Pred cohort study. PG - e045702 LID - 10.1136/bmjopen-2020-045702 [doi] LID - e045702 AB - INTRODUCTION: In the field of arthroscopic rotator cuff repair (ARCR), reporting standards of published studies differ dramatically, notably concerning adverse events (AEs). In addition, prognostic studies are overall methodologically poor, based on small data sets and explore only limited numbers of influencing factors. We aim to develop prognostic models for individual ARCR patients, primarily for the patient-reported assessment of shoulder function (Oxford Shoulder Score (OSS)) and the occurrence of shoulder stiffness 6 months after surgery. We also aim to evaluate the use of a consensus core event set (CES) for AEs and validate a severity classification for these events, considering the patient's perspective. METHODS AND ANALYSIS: A cohort of 970 primary ARCR patients will be prospectively documented from several Swiss and German orthopaedic clinics up to 24 months postoperatively. Patient clinical examinations at 6 and 12 months will include shoulder range of motion and strength (Constant Score). Tendon repair integrity status will be assessed by ultrasound at 12 months. Patient-reported questionnaires at 6, 12 and 24 months will determine functional scores (subjective shoulder value, OSS), anxiety and depression scores, working status, sports activities, and quality of life (European Quality of Life 5 Dimensions 5 Level questionnaire). AEs will be documented according to a CES. Prognostic models will be developed using an internationally supported regression methodology. Multiple prognostic factors, including patient baseline demographics, psychological, socioeconomic and clinical factors, rotator cuff integrity, concomitant local findings, and (post)operative management factors, will be investigated. ETHICS AND DISSEMINATION: This project contributes to the development of personalised risk predictions for supporting the surgical decision process in ARCR. The consensus CES may become an international reference for the reporting of complications in clinical studies and registries. Ethical approval was obtained on 1 April 2020 from the lead ethics committee (EKNZ, Basel, Switzerland; ID: 2019-02076). All participants will provide informed written consent before enrolment in the study. TRIAL REGISTRATION NUMBER: NCT04321005. PROTOCOL VERSION: Version 2 (13 December 2019). CI - (c) Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ. FAU - Audige, Laurent AU - Audige L AUID- ORCID: 0000-0003-3962-3996 AD - Research and Development, Schulthess Klinik, Zurich, Switzerland laurent.audige@unibas.ch. AD - Orthopaedic Surgery and Traumatology, University Hospital Basel, Basel, Switzerland. AD - Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland. FAU - Bucher, Heiner C C AU - Bucher HCC AD - Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland. FAU - Aghlmandi, Soheila AU - Aghlmandi S AD - Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland. FAU - Stojanov, Thomas AU - Stojanov T AD - Research and Development, Schulthess Klinik, Zurich, Switzerland. AD - Orthopaedic Surgery and Traumatology, University Hospital Basel, Basel, Switzerland. AD - Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital Basel, Basel, Switzerland. FAU - Schwappach, David AU - Schwappach D AUID- ORCID: 0000-0001-8668-3065 AD - Swiss Patient Safety Foundation, Zurich, Switzerland. AD - Institute of Social and Preventive Medicine, University of Bern, Bern, Switzerland. FAU - Hunziker, Sabina AU - Hunziker S AD - Medical Communication/Psychosomatic Medicine, University Hospital Basel, Basel, Switzerland. FAU - Candrian, Christian AU - Candrian C AD - Trauma and Ortho Unit, Ospedale Regionale di Lugano, Lugano, Switzerland. FAU - Cunningham, Gregory AU - Cunningham G AD - Shoulder Center, Hirslanden Clinique La Colline, Geneva, Switzerland. AD - Division of Orthopaedics and Trauma Surgery, Department of Surgery, Geneva University Hospitals, Geneve, Switzerland. FAU - Durchholz, Holger AU - Durchholz H AD - Klinik Gut Sankt Moritz, Saint Moritz, Switzerland. FAU - Eid, Karim AU - Eid K AD - Clinic for Orthopaedics and Traumatology, Baden Cantonal Hospital, Baden, Switzerland. FAU - Flury, Matthias AU - Flury M AD - Center for Orthopaedics and Neurosurgery, In-Motion, Wallisellen, Switzerland. FAU - Jost, Bernhard AU - Jost B AD - Clinic for Orthopaedic Surgery and Traumatology of the Musculoskeletal System, Cantonal Hospital of St.Gallen, St Gallen, Switzerland. FAU - Ladermann, Alexandre AU - Ladermann A AD - Division of Orthopaedics and Trauma Surgery, Department of Surgery, Geneva University Hospitals, Geneve, Switzerland. AD - Division of Orthopaedics and Trauma Surgery, La Tour Hospital, Meyrin, Switzerland. FAU - Moor, Beat Kaspar AU - Moor BK AD - Service for Orthopaedics and Traumatology of the Musculoskeletal System, Hopital du Valais - Centre Hospitalier du Valais Romand, Martigny, Switzerland. FAU - Moroder, Philipp AU - Moroder P AD - Department of Shoulder and Elbow Surgery, Center for Musculoskeletal Surgery, Charite Medicine University, Berlin, Germany. FAU - Rosso, Claudio AU - Rosso C AD - Shoulder and Elbow Center, Arthro Medics, Basel, Switzerland. FAU - Schar, Michael AU - Schar M AD - Department of Orthopaedic Surgery and Traumatology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland. FAU - Scheibel, Markus AU - Scheibel M AD - Department of Shoulder and Elbow Surgery, Center for Musculoskeletal Surgery, Charite Medicine University, Berlin, Germany. AD - Shoulder and Elbow Surgery, Schulthess Klinik, Zurich, Switzerland. FAU - Spormann, Christophe AU - Spormann C AD - Center for Endoprosthetics and Joint Surgery, Endoclinic, Zurich, Switzerland. FAU - Suter, Thomas AU - Suter T AD - Orthopaedic Shoulder and Elbow, Canton Hospital Baselland, Bruderholz, Switzerland. FAU - Wieser, Karl AU - Wieser K AD - Department of Orthopaedics, Balgrist University Hospital, University of Zurich, Zurich, Switzerland. FAU - Zumstein, Matthias AU - Zumstein M AD - Shoulder, Elbow and Orthopaedic Sports Medicine, Orthopaedics Sonnenhof, Bern, Switzerland. AD - Campus SLB, Swiss Institute for Translational and Entrepreneurial Medicine, Stiftung Lindenhof, Bern, Switzerland. CN - ARCR_Pred Study Group FAU - Muller, Andreas M AU - Muller AM AD - Orthopaedic Surgery and Traumatology, University Hospital Basel, Basel, Switzerland. LA - eng SI - ClinicalTrials.gov/NCT04321005 PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20210422 PL - England TA - BMJ Open JT - BMJ open JID - 101552874 SB - IM MH - Arthroscopy MH - Cohort Studies MH - Humans MH - Multicenter Studies as Topic MH - Quality of Life MH - *Rotator Cuff/diagnostic imaging/surgery MH - *Rotator Cuff Injuries/surgery MH - Switzerland MH - Treatment Outcome PMC - PMC8070866 OTO - NOTNLM OT - musculoskeletal disorders OT - orthopaedic & trauma surgery OT - shoulder COIS- Competing interests: None declared. FIR - Buchschacher, Jannine IR - Buchschacher J FIR - Fankhauser, Lena IR - Fankhauser L FIR - Eicher, Corinne IR - Eicher C FIR - Willscheid, Gernot IR - Willscheid G FIR - Akgun, Doruk IR - Akgun D FIR - Thiele, Kathi IR - Thiele K FIR - Minkus, Marvin IR - Minkus M FIR - Danzinger, Victor IR - Danzinger V FIR - Karpinski, Katrin IR - Karpinski K FIR - Mueller, Sebastian IR - Mueller S FIR - Haag-Schumacher, Claudia IR - Haag-Schumacher C FIR - Steffen, Viviane IR - Steffen V FIR - Fournier, Sarah IR - Fournier S FIR - Marietan, Deborah IR - Marietan D FIR - Pawlak, Sebastien IR - Pawlak S FIR - Hansen, Britta IR - Hansen B FIR - Lovrek, Ferdinand IR - Lovrek F FIR - Zanetti, Marco IR - Zanetti M FIR - Mamisch, Nadja IR - Mamisch N FIR - Steiner, Christian IR - Steiner C FIR - Ahlbaumer, Georg IR - Ahlbaumer G FIR - Bram, Jakob IR - Bram J FIR - Fischer, Jens IR - Fischer J FIR - Delvendahl, Alexander IR - Delvendahl A FIR - Simao, Patricia IR - Simao P FIR - Khourani, Abed IR - Khourani A FIR - Foucault, Anne-Sophie IR - Foucault AS FIR - Kolo, Frank IR - Kolo F FIR - Schenk, Adrian IR - Schenk A FIR - Weihs, Johannes IR - Weihs J FIR - Fluckiger, Remy IR - Fluckiger R FIR - Scacchi, Philipp IR - Scacchi P FIR - Lombardo, Paolo IR - Lombardo P FIR - Hubscher, Larissa IR - Hubscher L FIR - Berther, Ralph IR - Berther R FIR - Ehrmann, Christine IR - Ehrmann C FIR - Nobs, Raffaela IR - Nobs R FIR - Niehaus, Richard IR - Niehaus R FIR - Grunberger, Nisha IR - Grunberger N FIR - Kriechling, Philipp IR - Kriechling P FIR - Bensler, Susanne IR - Bensler S FIR - Schwyzer, Hans-Kaspar IR - Schwyzer HK FIR - Moro, Fabrizio IR - Moro F FIR - Glanzmann, Michael IR - Glanzmann M FIR - Wirth, Barbara IR - Wirth B FIR - Jung, Christian IR - Jung C FIR - Freislederer, Florian IR - Freislederer F FIR - Notzli, Manuela IR - Notzli M FIR - Bellmann, Frederik IR - Bellmann F FIR - Anne, Franz IR - Anne F FIR - Oswald, Jorg IR - Oswald J FIR - Marzel, Alex IR - Marzel A FIR - Grobet, Cecile IR - Grobet C FIR - Jong, Marije de IR - Jong M FIR - Wehrli, Martina IR - Wehrli M FIR - Schatz, Jan IR - Schatz J FIR - Marbach, Francesco IR - Marbach F FIR - Delcogliano, Marco IR - Delcogliano M FIR - Previtali, Davide IR - Previtali D FIR - Schonweger, Florian IR - Schonweger F FIR - Porro, Elena IR - Porro E FIR - Induni-Lang, Gabriela IR - Induni-Lang G FIR - Filardo, Giuseppe IR - Filardo G FIR - Del Grande, Filippo IR - Del Grande F FIR - Feltri, Pietro IR - Feltri P FIR - Guglielmo, Schiavon IR - Guglielmo S FIR - Spross, Christian IR - Spross C FIR - Olach, Martin IR - Olach M FIR - Badulescu, Michael IR - Badulescu M FIR - Zdravkovic, Vilijam IR - Zdravkovic V FIR - Luscher, Stephanie IR - Luscher S FIR - Scheler, Jorg IR - Scheler J FIR - Ohrstrom, Lena IR - Ohrstrom L FIR - Hayoz, Annabel IR - Hayoz A FIR - Schuster, Frederick IR - Schuster F FIR - Muller-Lebschi, Julia IR - Muller-Lebschi J FIR - Gerber, Christian IR - Gerber C FIR - Bouaicha, Samy IR - Bouaicha S FIR - Borbas, Paul IR - Borbas P FIR - Hasler, Anita IR - Hasler A FIR - Grubhofer, Florian IR - Grubhofer F FIR - Catanzaro, Sabrina IR - Catanzaro S FIR - Wyss, Sabine IR - Wyss S FIR - Sutter, Reto IR - Sutter R FIR - Taha, Mohy IR - Taha M FIR - Baum, Cornelia IR - Baum C FIR - Ahlborn, Ilona IR - Ahlborn I FIR - Hatz, Simone IR - Hatz S FIR - Tamborrini-Schutz, Giorgio IR - Tamborrini-Schutz G FIR - Appenzeller-Herzog, Christian IR - Appenzeller-Herzog C EDAT- 2021/04/24 06:00 MHDA- 2021/05/21 06:00 PMCR- 2021/04/22 CRDT- 2021/04/23 05:45 PHST- 2021/04/23 05:45 [entrez] PHST- 2021/04/24 06:00 [pubmed] PHST- 2021/05/21 06:00 [medline] PHST- 2021/04/22 00:00 [pmc-release] AID - bmjopen-2020-045702 [pii] AID - 10.1136/bmjopen-2020-045702 [doi] PST - epublish SO - BMJ Open. 2021 Apr 22;11(4):e045702. doi: 10.1136/bmjopen-2020-045702.