Ergebnismessung in der Hüft- und Knieendoprothetik – Empfehlung der Deutschen Gesellschaft für Endoprothetik (AE)

Abkürzungsverzeichnis

AE: Adverse Event

COS: Core Outcome Set

EPRD: Endoprothesenregister Deutschland

EPZ: Zertifiziertes EndoProthetikZentrum

EQ-5D: EuroQoL (European Quality of Life) – 5 Dimensions

GCP: Good clinical Practice

HOOS: Hip Disability and Osteoarthritis Outcome Score

ICHOM: International Consortium for Health Outcomes Measurement

IQTIG: Institut für Qualitätssicherung und Transparenz im Gesundheitswesen

KOOS: Knee Injury and Osteoarthritis Outcome Score

OHS: Oxford Hip Score

OKS: Oxford Knee Score

OMERACT: Outcome Measures in Rheumatology

OP: Operation

PROM: Patient-reported Outcome Measures

SAE: Serious adverse Event

SF-12: Short Form 12 Health Survey

SF-36: Short Form 36 Health Survey

VAS: visuelle Analogskala

WOMAC: Western Ontario and McMasters Universities Osteoarthritis Index
 

• Literatur

• 1 IQTIG. Qualitätsreport 2017. Im Internet: https://iqtig.org/downloads/berichte/2017/IQTIG_Qualitaetsreport-2017_2018_09_21.pdf Stand: 14.11.2019
• 2 Augurzky B, Hentschker C, Pilny A, Wübker A. Krankenhausreport 2017. Schriftenreihe zur Gesundheitsanalyse. Band 4. Im Internet: https://www.barmer.de/blob/124290/ff9429ae5b958c69aef00cfbd0049033/data/dl-report.pdf Stand: 14.11.2019
• 3 Techniker Krankenkasse. TK-Klinikführer. Im Internet: https://www.tk.de/tk/klinikfuehrer/114928 Stand: 14.11.2019
• 4 Weiße Liste gemeinnützige GmbH. AOK-Krankenhausnavigator. Im Internet: https://weisse-liste.krankenhaus.aok.de/ Stand: 14.11.2019
• 5 Lange T, Rataj E, Kopkow C. et al. Outcome Assessment in Total Knee Arthroplasty: A Systematic Review and Critical Appraisal. J Arthroplasty 2017; 32: 653-665.e1
• 6 Patient Reported Outcome Measures (PROMs). 2017. Im Internet: https://digital.nhs.uk/data-and-information/publications/statistical/patient-reported-outcome-measures-proms Stand: 14.11.2019
• 7 Chan AW, Tetzlaff JM, Gøtzsche PC. et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ 2013; 346: e7586
• 8 Bellamy N, Kirwan J, Boers M. et al. Recommendations for a core set of outcome measures for future phase III clinical trials in knee, hip, and hand osteoarthritis. Consensus development at OMERACT III. J Rheumatol 1997; 24: 799-802
• 9 Singh JA, Dohm M, Choong PF. Consensus on draft OMERACT core domains for clinical trials of Total Joint Replacement outcome by orthopaedic surgeons: a report from the International consensus on outcome measures in TJR trials (I-COMiTT) group. BMC Musculoskelet Disord 2017; 18: 45
• 10 Williams K, Sansoni J, Morris D, Grootemaat P, Thompson C. Patient-reported outcome measures: Literature review. 2016. Im Internet: https://www.safetyandquality.gov.au/sites/default/files/migrated/PROMs-Literature-Review-December-2016.pdf Stand: 14.11.2019
• 11 ICHOM. International Consortium for Health Outcomes Measurement. 2017. Im Internet: https://www.ichom.org/ Stand: 14.11.2019
• 12 Naal FD, Impellizzeri FM, Sieverding M. et al. The 12-item Oxford Knee Score: cross-cultural adaptation into German and assessment of its psychometric properties in patients with osteoarthritis of the knee. Osteoarth Cartil 2009; 17: 49-52
• 13 Naal FD, Sieverding M, Impellizzeri FM. et al. Reliability and validity of the cross-culturally adapted German Oxford hip score. Clin Orthop Relat Res 2009; 467: 952-957
• 14 Murray DW, Fitzpatrick R, Rogers K. et al. The use of the Oxford hip and knee scores. J Bone Joint Surg Br 2007; 89: 1010-1014
• 15 Harris K, Dawson J, Doll H. et al. Can pain and function be distinguished in the Oxford Knee Score in a meaningful way? An exploratory and confirmatory factor analysis. Qual Life Res 2013; 22: 2561-2568
• 16 Harris KK, Price AJ, Beard DJ. et al. Can pain and function be distinguished in the Oxford Hip Score in a meaningful way?: an exploratory and confirmatory factor analysis. Bone Joint Res 2014; 3: 305-309
• 17 Dawson J, Fitzpatrick R, Carr A. et al. Questionnaire on the perceptions of patients about total hip replacement. J Bone Joint Surg Br 1996; 78: 185-190
• 18 Dawson J, Fitzpatrick R, Murray D. et al. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg Br 1998; 80: 63-69
• 19 Blasimann A, Dauphinee SW, Staal JB. Translation, cross-cultural adaptation, and psychometric properties of the German version of the hip disability and osteoarthritis outcome score. J Orthop Sports Phys Ther 2014; 44: 989-997
• 20 Klassbo M, Larsson E, Mannevik E. Hip disability and osteoarthritis outcome score. An extension of the Western Ontario and McMaster Universities Osteoarthritis Index. Scand J Rheumatol 2003; 32: 46-51
• 21 Kessler S, Lang S, Puhl W. et al. [The Knee Injury and Osteoarthritis Outcome Score–a multifunctional questionnaire to measure outcome in knee arthroplasty]. Z Orthop Ihre Grenzgeb 2003; 141: 277-282
• 22 Roos EM, Roos HP, Lohmander LS. et al. Knee Injury and Osteoarthritis Outcome Score (KOOS)–development of a self-administered outcome measure. J Orthop Sports Phys Ther 1998; 28: 88-96
• 23 Bellamy N, Buchanan WW, Goldsmith CH. et al. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol 1988; 15: 1833-1840
• 24 Stucki G, Meier D, Stucki S. et al. [Evaluation of a German version of WOMAC (Western Ontario and McMaster Universities) Arthrosis Index]. Z Rheumatol 1996; 55: 40-49
• 25 Noble PC, Scuderi GR, Brekke AC. et al. Development of a new Knee Society scoring system. Clin Orthop Relat Res 2012; 470: 20-32
• 26 Behrend H, Giesinger K, Giesinger JM. et al. The “forgotten joint” as the ultimate goal in joint arthroplasty: validation of a new patient-reported outcome measure. J Arthroplasty 2012; 27: 430-436
• 27 Dawson J, Beard DJ, McKibbin H. et al. Development of a patient-reported outcome measure of activity and participation (the OKS-APQ) to supplement the Oxford knee score. Bone Joint J 2014; 96-B: 332-338
• 28 Kantz ME, Harris WJ, Levitsky K. et al. Methods for assessing condition-specific and generic functional status outcomes after total knee replacement. Med Care 1992; 30 (5 Suppl.): MS240-MS252
• 29 EuroQol Group. 2017. European Quality of Life (EuroQol). Im Internet: https://euroqol.org/euroqol/ Stand: 14.11.2019
• 30 Mahomed N, Gandhi R, Daltroy L. et al. The self-administered patient satisfaction scale for primary hip and knee arthroplasty. Arthritis 2011; 2011: 591253
• 31 Brokelman RB, Haverkamp D, van Loon C. et al. The validation of the visual analogue scale for patient satisfaction after total hip arthroplasty. Eur Orthop Traumatol 2012; 3: 101-105
• 32 Bullens PH, van Loon CJ, de Waal Malefijt MC. et al. Patient satisfaction after total knee arthroplasty: a comparison between subjective and objective outcome assessments. J Arthroplasty 2001; 16: 740-747
• 33 Sharkey PF, Lichstein PM, Shen C. et al. Why are total knee arthroplasties failing today–has anything changed after 10 years?. J Arthroplasty 2014; 29: 1774-1778
• 34 Thiele K, Perka C, Matziolis G. et al. Current failure mechanisms after knee arthroplasty have changed: polyethylene wear is less common in revision surgery. J Bone Joint Surg Am 2015; 97: 715-720
• 35 Bozic KJ, Kurtz SM, Lau E. et al. The epidemiology of revision total hip arthroplasty in the United States. J Bone Joint Surg Am 2009; 91: 128-133
• 36 ICH. Integrated Addendum to ICH E6(R1): Guideline for good clinical practice E6(R2). 2016. Im Internet: https://www.fda.gov/media/93884/download Stand: 14.11.2019
• 37 Kirschner S, Lützner J, Günther KP. et al. Adverse events in total knee arthroplasty: Results of a physician independent survey in 260 patients. Patient Saf Surg 2010; 4: 12
• 38 ISO. ISO 14155 : 2011. Clinical Investigation of medical Devices for human Subjects – Good clinical Practice. Geneva, Switzerland: ISO; 2011
• 39 Australian Orthopaedic Association, Australian Orthopaedic Association National Joint Replacement Registry. Hip, Knee & Shoulder Arthroplasty. Annual Report 2016. Adelaide: AOA; 2016
• 40 The Swedish Knee Arthroplasty Register. Annual Report 2016. Im Internet: http://www.myknee.se/pdf/SVK_2016_Eng_1.0.pdf Stand: 14.11.2019
• 41 The Swedish Hip Arthroplasty Register. Annual Report 2015. Im Internet: https://registercentrum.blob.core.windows.net/shpr/r/Annual-Report-2015-H19dFINOW.pdf Stand: 14.11.2019
• 42 National Joint Registry. 14th Annual Report 2017. National Joint Registry for England, Wales, Northern Ireland and the Isle of Man. Im Internet: https://www.hqip.org.uk/resource/national-joint-registry-14th-annual-report-2017/%23.Xc2AjebsZaQ Stand: 14.11.2019
• 43 Von Roth P, Lützner J, Günther KP. et al. Die radiologische Verlaufskontrolle von primären Hüft- und Knieendoprothesen – Empfehlung der Deutschen Gesellschaft für Endoprothetik (AE). Im Internet: https://www.ae-germany.com/die-ae/ae-publikationen/ae-handlungsempfehlungen
• 44 Beard DJ, Harris K, Dawson J. et al. Meaningful changes for the Oxford hip and knee scores after joint replacement surgery. J Clin Epidemiol 2015; 68: 73-79
• 45 Berliner JL, Brodke DJ, Chan V. et al. John Charnley Award: Preoperative Patient-reported Outcome Measures Predict Clinically Meaningful Improvement in Function After THA. Clin Orthop Relat Res 2016; 474: 321-329
• 46 Clement ND, MacDonald D, Simpson AH. The minimal clinically important difference in the Oxford knee score and Short Form 12 score after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 2014; 22: 1933-1939
• 47 Berliner JL, Brodke DJ, Chan V. et al. Can Preoperative Patient-reported Outcome Measures Be Used to Predict Meaningful Improvement in Function After TKA?. Clin Orthop Relat Res 2017; 475: 149-157
• 48 Singh JA, Luo R, Landon GC. et al. Reliability and clinically important improvement thresholds for osteoarthritis pain and function scales: a multicenter study. J Rheumatol 2014; 41: 509-515
• 49 Pham T, van der Heijde D, Altman RD. et al. OMERACT-OARSI initiative: Osteoarthritis Research Society International set of responder criteria for osteoarthritis clinical trials revisited. Osteoarthr Cartil 2004; 12: 389-399
• 50 Escobar A, García Pérez L, Herrera-Espiñeira C. et al. Total knee replacement; minimal clinically important differences and responders. Osteoarthr Cartil 2013; 21: 2006-2012
• 51 Quintana JM, Aguirre U, Barrio I. et al. Outcomes after total hip replacement based on patientsʼ baseline status: what results can be expected?. Arthritis Care Res (Hoboken) 2012; 64: 563-572
• 52 König HH, Bernert S, Angermeyer MC. et al. Comparison of population health status in six european countries: results of a representative survey using the EQ-5D questionnaire. Med Care 2009; 47: 255-261
• 53 Bullinger M, Kirchberger I. SF-36 Fragebogen zum Gesundheitszustand. Göttingen: Hofgrefe; 1998
• 54 Rolfson O, Eresian Chenok K, Bohm E. et al. Patient-reported outcome measures in arthroplasty registries. Acta Orthop 2016; 87 (Suppl. 01) 3-8
• 55 Rolfson O, Bohm E, Franklin P. et al. Patient-reported outcome measures in arthroplasty registries Report of the Patient-Reported Outcome Measures Working Group of the International Society of Arthroplasty Registries Part II. Recommendations for selection, administration, and analysis. Acta Orthop 2016; 87 (Suppl. 01) 9-23