Abstract
Background
Well-documented clinical data registers are valuable for assessing the effectiveness of surgical interventions.
Objective
The aim of this study was to present our initial experience with the implementation of a local register documenting patients with arthroscopic rotator cuff tear reconstruction (ARCR).
Materials and methods
Standardized documentation of demographic, baseline, and surgery characteristics of ARCR patients was initiated in February 2010. Patient follow-up at 6 months postsurgery began in June 2014 using various objective and subjective patient-reported outcomes (PROs) including the Constant–Murley Score (CS), Oxford Shoulder Score (OSS) and Subjective Shoulder Value (SSV). An additional 2- to 4-year postoperative evaluation of PROs and level of satisfaction was made by postal questionnaire. The proportion of cases documented in the register and the initial patient outcomes were examined.
Results
The overall documentation rate of ARCR patients was 59 % (1,092/1,860) with 11 of 19 surgeons achieving 76 % altogether. Ninety-eight percent (45/46) of patients were documented at 6 months; the mean CS, OSS, and SSV improved significantly by 17.0 points, 11.4 points, and 35.6 %, respectively (p < 0.001). There were 58 % (174/301) postal questionnaire respondents showing similar improvements in OSS and SSV, with 91 % of patients rating 8 points or more on a 0–10 satisfaction scale.
Conclusion
The implementation of an ARCR clinical register is achievable by motivated surgeons with adequate support for data collection and control. Long-term postsurgery PROs show treatment effectiveness associated with high patient satisfaction.
Zusammenfassung
Hintergrund
Gut dokumentierte klinische Datenregister sind wertvoll, um die Wirksamkeit chirurgischer Eingriffe zu evaluieren.
Ziel der Studie
Präsentation unserer Erfahrung mit der Entwicklung eines lokalen Registers zur Dokumentation von Patienten mit arthroskopischer Rekonstruktion der Rotatorenmanschette (ARCR).
Material und Methoden
Seit Februar 2010 wurden bei allen ARCR-Patienten die präoperativen Baseline-Daten sowie die operativen Details systematisch erfasst. Im Juni 2014 wurden zusätzlich objektive und subjektive Ergebnismessungen 6 Monate postoperativ eingeführt (Constant-Score, CS; Oxford Shoulder Score, OSS; Subjective Shoulder Value, SSV). Eine postalische Befragung der Patienten erfolgte zudem 2–4 Jahre postoperativ. Die Vollständigkeit der im Register erfassten Fälle sowie erste funktionelle Ergebnisse der Patienten und deren Zufriedenheit wurden untersucht.
Ergebnisse
Die Gesamtdokumentationsrate der ARCR-Patienten lag bei 59 % (1092/1860), wobei 11 von 19 beteiligten Chirurgen zusammen eine Rate von 76 % erreichten. Bei den 6-Monats-Kontrollen wurden 98 % (45/46) der Fälle dokumentiert. Der mittlere CS, OSS und SSV verbesserten sich signifikant um 17,0 bzw. 11,4 Punkte und 35.6 % (p < 0,001). Die 58 % Rückmeldungen (174/301) der postalischen Befragung zeigten ähnliche Verbesserungen im OSS und SSV, mit 91 % der Patienten, die 8 oder mehr Punkte auf der Zufriedenheitsskala (0–10) angekreuzt hatten.
Schlussfolgerung
Die Einführung eines klinischen Registers für ARCR kann mit motivierten Chirurgen und entsprechender Unterstützung bei Datenerfassung und -management erreicht werden. Langzeitbefragungen zeigen den Behandlungserfolg und die damit verbundene Patientenzufriedenheit.
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Acknowledgments
The authors would like to thank D. Rickenbacher for supporting in the preparation of study documents and M. Wilhelmi, PhD, for the preparation and proofreading of this manuscript.
Support for this research was provided by
Schulthess Clinic.
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M. Flury is a paid consultant for and receives royalties from Arthrex Inc. C. Kolling, C. Grobet, S. Kunz and L. Audigé state that they have no conflicts of interest.
All studies on humans described in the present manuscript were carried out with the approval of the responsible ethics committee and in accordance with national law and the Helsinki Declaration of 1975 (in its current, revised form). Informed consent was obtained from all patients included in studies.
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Flury, M., Kolling, C., Grobet, C. et al. Implementation of a local outcome register for arthroscopic rotator cuff tear repair. Obere Extremität 10, 33–40 (2015). https://doi.org/10.1007/s11678-014-0299-4
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DOI: https://doi.org/10.1007/s11678-014-0299-4