Project details

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Development and reliability study of the electronic, smartphone-administered, version of the paper-based Dutch Quality of Recovery-15 scale

Keywords:
questionnaire quality of recovery patient reported outcome measure

Researchers:
prof dr JKG Wietasch
JCN de Vlieger
JL Bezemer

Type of project:
Stage Wetenschap / Research project

Nature of the research:
A prospective, observational, randomized crossover study.

Fields of study:
anesthesiology

Background / introduction
Recovery after surgery and anaesthesia is a complex process dependent on patient, surgical, and anaesthetic characteristics and the presence of numerous adverse sequelae. Most studies evaluating recovery after anaesthesia and surgery have focused primarily on physiological endpoints, recovery times, and the incidence of adverse events, such as major morbidity and mortality. Although these parameters are important and should be measured, they mostly ignore the quality of recovery (QoR) from the patient’s perspective (1). The patient’s QoR can be measured by the multidimensional 15-item Quality of Recovery scale (QoR-15) questionnaire, a valid, reliable, responsive and easy-to-use patient-reported outcome measure (PROM) (2, 3). Currently, the QoR-15 is strongly recommended as a standard outcome measure of QoR in clinical trials in surgery and anaesthesia (2). Furthermore, it could be a useful outcome measure for assessing the impact of healthcare delivery changes for quality assurance purposes (1).

We recently translated and validated the paper-based Dutch version of the QoR-15 scale (QoR-15NL). This work is not yet published at the time of writing and was registered in the UMCG Research Register under project number 201900402. However, visiting patients to administer the paper-based QoR-15NL is labour intensive, limiting the QoR-15NL’s feasibility in both research and clinical practice. For future studies, the least labour intensive and most convenient method of administrating the QoR-15NL should be used. Administration of the QoR-15NL on the patient’s smartphone would fit these criteria. The creation of this electronic, smartphone-administered version of the QoR-15NL (eQoR-15NL) will require adapting the original ‘paper and pencil’ mode of administration to an electronic mode of administration. Furthermore, the eQoR-15NL will be subject to the same scrutiny as would a paper-based measure. Empirical evidence will be required to demonstrate measurement equivalence. (i.e. the measurement properties of the eQoR-15NL are comparable if not superior to the original format) (9).
Research question / problem definition
Does the eQoR-15NL have comparable measurement properties (i.e. measurement equivalence) compared to the paper-based QoR-15NL questionnaire?
Workplan
First, the digital questionnaire will be developed by RoQua. An expert panel will review the first draft, which will become the pilot version of the eQoR-15NL. This pilot version will be tested by at least 7 patients who belong to the target population. I.e. they underwent surgery under general anaesthesia and will be assessed on the 1st postoperative day. These patients will be interviewed to assess if they experience issues with administering the questionnaire. In case of issues, the expert panel will revise the questionnaire as needed. When no new issues arise, the pilot version will become the definitive version of the eQoR-15NL questionnaire.

The eQoR-15NL will then be completed by 48 patients who belong to the same target group as described above. Patients will be randomly divided into two groups. One group will complete the digital eQoR-15NL first, followed by the paper-based version, and the other group will start with the paper-based version followed by the digital version. The primairy outcome measure will be the intraclass correlation coëfficiënt (ICC).

The medical student will collect data (which will take approximately 4-5 weeks during step 2), perform the necessary study administration, build the study database, and analyse data. During the project, the student will be assisted by and collaborate with an anaesthesiology resident. Finally, co-authorship of the final publication can be an option for an enthusiast student.
References
1. Stark PA, Myles PS, Burke JA. Development and psychometric evaluation of a postoperative quality of recovery score: the QoR-15. Anesthesiology 2013; 118(6): 1332-1340, doi: 10.1097/ALN.0b013e318289b84b [doi]

2. Kleif J, Waage J, Christensen KB, Gogenur I. Systematic review of the QoR-15 score, a patient- reported outcome measure measuring quality of recovery after surgery and anaesthesia. Br J Anaesth 2018; 120(1): 28-36, doi: S0007-0912(17)54002-7 [pii]

3. Myles P, Myles D, Galagher W, Chew C, MacDonald N, Dennis A. Minimal Clinically Important Difference for Three Quality of Recovery Scales. Anesthesiology (Philadelphia) 2016; 125(1): 39-45, doi: 10.1097/ALN.0000000000001158

4. Peccora C, Gimlich R, Cornell R, Vacanti C, Ehrenfeld J, Urman R. Anesthesia Report Card – A Customizable Tool for Performance Improvement. J Med Syst 2014; 38(9): 1-10, doi: 10.1007/s10916-014-0105-2

5. Oxman AD, Thomson MA, Davis DA, Haynes RB. No magic bullets: a systematic review of 102 trials of interventions to improve professional practice. Canadian Medical Association journal 1995; 153(10): 1423-1431

6. Jamtvedt G, Young JM, Kristoffersen DT, O’Brien MA, Oxman AD. Does telling people what they have been doing change what they do? A systematic review of the effects of audit and feedback. Quality & safety in health care 2006; 15(6): 433-436, doi: 10.1136/qshc.2006.018549

7. Kleif J, Edwards HM, Sort R, Vilandt J, Gogenur I. Translation and validation of the Danish version of the postoperative quality of recovery score QoR-15. Acta Anaesthesiol Scand 2015; 59(7): 912-920, doi: 10.1111/aas.12525 [doi]

8. Demumieux F, Ludes P, Diemunsch P, et al. Validation of the translated Quality of Recovery-15 questionnaire in a French-speaking population. British journal of anaesthesia : BJA 2020; 124(6): 761-767, doi: 10.1016/j.bja.2020.03.011

9. Coons SJ, PhD, Gwaltney CJ, PhD, Hays RD, PhD, et al. Recommendations on Evidence Needed to Support Measurement Equivalence between Electronic and Paper-Based Patient-Reported Outcome (PRO) Measures: ISPOR ePRO Good Research Practices Task Force Report. Value in health 2009; 12(4): 419-429, doi: 10.1111/j.1524-4733.2008.00470.x

10. Anonymous RoQua. Available from https://www.roqua.nl/research/ (accessed 26-1- 2021)

11. Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO good research practices task force report: part 1--eliciting concepts for a new PRO instrument. Value Health 2011; 14(8): 967-977, doi: 10.1016/j.jval.2011.06.014 [doi]

12. Patrick DL, Burke LB, Gwaltney CJ, et al. Content validity--establishing and reporting the evidence in newly developed patient-reported outcomes (PRO) instruments for medical product evaluation: ISPOR PRO Good Research Practices Task Force report: part 2--assessing respondent understanding. Value Health 2011; 14(8): 978-988, doi: 10.1016/j.jval.2011.06.013 [doi]

13. Terwee CB, Prinsen CAC, Chiarotto A, et al. COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study. Qual Life Res 2018; 27(5): 1159-1170, doi: 10.1007/s11136-018-1829-0

14. Walter SD, Eliasziw M, Donner A. Sample size and optimal designs for reliability studies. Statistics in medicine 1998; 17(1): 101-110, doi: 10.1002/(SICI)1097-0258(19980115)17:13.0.CO;2-E

15. Kristensen SD, Knuuti J, Saraste A, et al. 2014 ESC/ESA Guidelines on non-cardiac surgery: cardiovascular assessment and management The Joint Task Force on non-cardiac surgery: cardiovascular assessment and management of the European Society of Cardiology (ESC) and the European Society of Anaesthesiology (ESA). European journal of anaesthesiology 2014; 31(10): 517-573, doi: 10.1097/EJA.0000000000000150

16. Terwee CB, Prinsen CAC, Chiarotto A, et al. COSMIN methodology for evaluating the content validity of patient-reported outcome measures: a Delphi study. Qual Life Res 2018; 27(5): 1159-1170, doi: 10.1007/s11136-018-1829-0 [doi]
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