Quality Assurance in Cataract and Lens Surgery with Special Consideration of Subjective Patient Reported Outcome Measures and Clinical Reported Outcome Measures

Abstract

Background Results of medical interventions must be documented and evaluated. In studies, this is done with clinical outcomes data (clinician/clinical reported outcome measure, CROM). In the past, less weight has been given to patient surveys with questionnaires (patient reported outcome measure, PROM).

Patients/Materials and Methods This retrospective study included 104 eyes from 53 patients. Of these, 35 patients had cataract surgery and 15 patients had a refractive lens exchange. The implanted lenses included 62 trifocal IOLs (Asphina trifiocal 839, Zeiss), 34 trifocal toric IOLs (Asphina trifocal toric 939, Zeiss) and 8 bifocal IOLs (Asphina 808, Zeiss) with the same IOL platform. Patients completed a modified questionnaire before surgery and one year after surgery. We made changes to the CatQuest-9SF questionnaire so as to also document side effects.

Results The effort required by the patients to answer the questionnaire was a burden. Transcribing the data into electronic files so as they could be saved and analyzed was a lot of work for the staff. Among the patients, 88.7% were spectacle-independent in everyday life, and 77.5% for reading. 44.4% had a halo problem. 92% reported the operation as a success. 100% had a prediction error of ≤ ± 0.75 dpt.

Conclusion There is a high rate of patient satisfaction with the outcome of the intervention. New questionnaires are needed for new IOLs. The Catquest-9SF is from 2009. Accordingly, revisions and new validation is necessary. Beyond that, only automatic data transfer will reduce the amount of work involved in data input.

Key words

cataract surgery - quality management - clinical reported outcome measure (CROM) - patient reported outcome measure (PROM)

Publication History

Received: 07 March 2021

Accepted: 05 July 2021

Article published online:
03 November 2021

• References/Literatur

• 1 Codmann EA. Study in Hospital Efficiency. Boston: T Todd Co.; 1917
• 2 Garratt A, Schmidt L, Mackintosh A. et al. Quality of life measurement: bibliographic study of patient assessed health outcome measures. BMJ 2002; 324: 1417
• 3 Pesudovs K, Garamendi E, Elliott DB. The Quality of Life Impact of Refractive Correction (QIRC) Questionnaire: Development and Validation. Optom Vis Sci 2004; 81: 769-777
• 4 Schein OD. The measurement of patient-reported outcomes of refractive surgery: the refractive status and vision profile. Trans Am Ophthalmol Soc 2000; 98: 439-469
• 5 Hays RD, Mangione CM, Ellwein L. et al. Psychometric properties of the National Eye Institute-Refractive Error Quality of Life instrument. Ophthalmology 2003; 110: 2292-2301
• 6 Kugelberg M, Lundström M. Factors related to the degree of success in achieving target refraction in cataract surgery. J Cataract Refract Surg 2008; 34: 1935-1939
• 7 Gothwal VK, Wright TA, Lamoureux EL. et al. Measuring outcomes of cataract surgery using the Visual Function Index-14. J Cataract Refract Surg 2010; 36: 1181-1188
• 8 Pesudovs K. Item banking. A generational change in patient-reported outcome-measurement. Optom Vis Sci 2010; 87: 285-293
• 9 Lundström M, Stenevi U, Thorburn W. The Swedish National Cataract Register: a 9-year review. Acta Ophthalmol Scand 2002; 80: 248-257
• 10 Khadka J, Gothwal VK, McLinden C. et al. The importance of rating scales in measuring patient-reported outcomes. Health Qual Life Outcomes 2012; 10: 80
• 11 Salowi MA, Goh PP, Lee MY. et al. The Malaysian Cataract Surgery Registry: Profile of Patients Presenting for Cataract Surgery. Asia Pac J Ophthalmol (Phila) 2015; 4: 191-196
• 12 § 135a SGB V Verpflichtung der Leistungserbringer zur Qualitätssicherung. Im Internet (Stand: 19.09.2021): http://www.sozialgesetzbuch-sgb.de/sgbv/135a
• 13 aQua-Institut für angewandte Qualitätsförderung und Forschung im Gesundheitswesen GmbH. Ergebnisbericht zum Probebetrieb für das Qualitätssicherungsverfahren Kataraktoperation. Stand: 5. Juni 2013. Im Internet (Stand: 19.09.2019): https://www.aqua-institut.de/fileadmin/aqua_de/Projekte/548_Probebetrieb_Katarakt/Kataraktoperation_Abschlussbericht_Probebetrieb.pdf
• 14 Rüggeber J-A, Bröckelmann J. Qualitätssicherung AQS1 hat sich für das Ambulante Operieren bewährt. Ambulant operieren 2004; 4: 151-156
• 15 Bäcker K, Fabian E. QS-Dokumentation zu Prozess- und Ergebnisqualität in der Katarakt-Chirurgie: AQS1-Katarakt online. Im Internet (Stand: 30.09.2021): https://www.dgii.org/archiv/2009/pdf/44.pdf
• 16 Bäcker K. AQS1 – Patientensicherheitsfragebogen. Qualitätsdokumentation, Langzeitergebnisse und Versorgungsforschung. In: Deindl C. Hrsg. Manual Ambulantes Operieren: Techniken, perioperative Verfahren und Management. Berlin: Walter de Gruyter; 2016: 150-161
• 17 Zollmann P. Innovative Praxis-EDV. Optimierung der Patientensicherheit. In: Deindl C. Hrsg. Manual Ambulantes Operieren: Techniken, perioperative Verfahren und Management. Berlin: Walter de Gruyter; 2016: 143-149
• 18 Mangione CM, Philipps RS, Seddon JM. et al. Development of the ‘Activities of daily Vision Scale’. A measure of visual functional status. Med Care 1992; 30: 1111-1126
• 19 Mangione CM, Berry S, Spitzer K. et al. Identifying the content area for the 51-item National Eye Institute Visual Function Questionnaire: results from focus groups with visually impaired persons. Arch Ophthalmol 1998; 116: 227-233
• 20 Magione CM, Lee PP, Gutierrez PR. et al. National Eye Institute Visual Function Questionnaire Field Test Investigators. Development of the 25-item National Eye Institute Visual Function Questionnaire. Arch Ophthalmol 2001; 119: 1050-1058
• 21 McAlinden C, Gothwal VK, Khadka J. et al. A head-to-head comparison of 16 cataract surgery outcome questionnaires. Ophthalmology 2011; 118: 2374-2381
• 22 Kohnen T. Questionnaires for cataract and refractive surgery. J Cataract Refract Surg 2019; 45: 119-120
• 23 Lundström M, Roos P, Jensen S. et al. Catquest questionnaire for use in cataract surgery care: description, validity, and reliability. J Cataract Refract Surg 1997; 23: 966-974
• 24 Lundström M, Pesudovs K. Catquest-9SF patient outcomes questionnaire: Nine-item short form Rasch-scaled revision of the Catquest questionnaire. J Cataract Refract Surg 2009; 35: 504-513
• 25 McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision questionnaire. Invest Ophthalmol Vis Sci 2010; 51: 5537-5545
• 26 Gerstmeyer K, Harreer A, Hirnschall N. et al. Pesudovs K, Lundström M, Findl O. Validierung der deutschen Version des schwedischen Catquest-9SF Fragebogens. In: DGII c/o Congress-Organisation Gerling GmbH. Hrsg. DGII Kongressband 2012. Düsseldorf: DGII; 2012: 214-222
• 27 Sparrow JM, Grzeda MT, Frost NA. et al. Cataract surgery patient-reported outcome measures: a head-to-head comparison of the psychometric performance and patient acceptability of the Cat-PROM5 and Catquest-9SF self-report questionnaires. Eye (Lond) 2018; 32: 788-795
• 28 International Consortium for Health Outcomes Measurement. Cataracts. The Standard Set. Im Internet (Stand: 19.09.2019): http://connect.ichom.org/standard-sets/cataracts/