Definitions Perioperative and perioperative period Refers to the pre-, intra- and postoperative phases of a patients surgical journey (1).

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1 A systematic review of health- related quality of life measures valid for perioperative care. Nathalie Stevenson, Matthew Chan, Tim Cook, Meghan Lane- Fall, Paul Myles, Mark Neuman, Ulrica Nilsson, Cor Kalkman, Mark Shulman and S. Ramani Moonesinghe Background When quality of life is considered in the context of health and disease, it is commonly referred to as health- related quality of life (HRQoL). Patient- reported outcome measures (PROMs) can be used to assess HRQoL, usually in the form of a questionnaire that the patient completes. PROMs can provide an indication of the outcomes or quality of care delivered to patients and allow potential for improvement in the quality of healthcare delivery. In the peri- operative literature, there is great heterogeneity in the type of PROMs employed to assess HRQoL, making it difficult to compare results between studies and in making decisions over how to improve care for peri- operative patients. Definitions Perioperative and perioperative period Refers to the pre-, intra- and postoperative phases of a patients surgical journey (1). Perioperative population Refers to any patient who has undergone any form of operative procedure, and who is assessed in any of the pre-, intra- and post- operative phases of the perioperative period Health- Related Quality- of- Life (HRQoL) The International Society for Quality of Life Research describes HRQoL as the functional effect of a medical condition and/or its consequent therapy upon a patient (2,3). HRQoL can be assessed through patient- reported outcome measures (PROMs). Patient- reported outcome (PRO) Is defined as an outcome that is determined and provided solely by the patient Patient- reported outcome measure (PROM) Refers to the method in which a patient- reported outcome is measured. Usually, this is in the form of a (validated) questionnaire. The Patient- Reported Outcomes Measurement Group in Oxford (4) have classified these PROM s into: Generic for general use, irrespective of medical condition or surgery (e.g. SF- 36). These can also those generic tool which are used to place a value or utility on a particular health state (e.g. EQ- 5D) Disease/condition- specific designed to capture issues of concern to people with particular medical/surgical conditions (e.g. Asthma Quality of Life Questionnaire) Domain/Dimension- specific designed to capture a specific facet of HRQoL in more depth e.g. anxiety of depression (e.g. Beck Depression Inventory) This review will concentrate on identifying studies that use generic PROMS that assess multiple constructs: HRQoL is broadly understood as being a 'multidimensional construct, which at minimum, consists of physical, mental and social domains' (5). PROTOCOL Review Question: Which endpoints are currently used to measure health- related quality of life in the perioperative literature, and what is their validity?

2 Review Objective: To identify the patient- reported outcome measures (PROMs) that are used to evaluate health- related quality of life (HRQoL) in clinical trials in perioperative patients. To summarise the relevant literature, to inform a Delphi consensus process to determine the measure(s) which are most appropriate for use in clinical trials in perioperative medicine. The systematic review and Delphi consensus process are part of the international Standardised Endpoints for Perioperative Medicine (StEP) initiative. Population: Adults (age 18 years) undergoing any type of surgery where health- related quality- of- life was measured before and after surgery using a generic patient- reported outcome measure Exclusion criteria: Any study including patients <18 years Any study where an operative intervention (using a surgical incision) was NOT performed e.g. endoscopy Any study where HRQOL was not assessed using a truly patient- reported method e.g. if clinicians filled in the data Any study where only a single construct of HRQOL was measured using a domain- specific PROM, or where a disease- specific PROM was used which cannot be generalised to the entire perioperative population. Any study where HRQOL was not measured using a PROM both before and after surgery Intervention: To identify the generic patient- reported outcome measures used to assess health- related quality- of- life during the perioperative period To review the feasibility, acceptability, validity, reliability and precision, of such patient- reported outcome measures Outcomes: The primary outcome will be HRQOL assessment, as measured by a patient- reported outcome measure. STUDY DESIGN AND METHODOLOGY Language All studies written in any language will be included to avoid language bias. Attempts will be made at translating articles, and where this is not possible, the article will be mentioned, but excluded from the final review. Publication type/status This review seeks to inform a Delphi consensus process. All studies to be included in this systematic review are peer- reviewed randomised- controlled trials with >100 patients recruited. Search Strategy 1) Databases MEDLINE and EMBASE will be searched for relevant articles. This search will be in order to identify the PROM s used in the perioperative literature. 2) To evaluate the validity of the particular PROMs that are cited in the literature; citation searching using Web of Science will be performed to identify those studies that have validated a particular PROM. Relevant grey literature, including clinicaltrials.gov will also be searched.

3 The search will combine variations of the term perioperative with variations of the term patient reported outcome (table 1). The search strategy has been developed with the assistance of a librarian and with reference to previously published systematic reviews of outcome measures for perioperative care and anaesthesia (6,7). The search will be limited to randomised controlled trials in human adults over age 18 years during the years The date limitations were applied to enable us to identify PROM in the recent perioperative literature that are likely to still be in use. PERIOPERATIVE 1. exp perioperative care 2. Preoperative care/ 3. Perioperative care/mp 4. exp Perioperative period 5. Peri?operative.mp 6. Pre?operative.mp 7. Intra?operative.mp 8. Post?operative.mp 9. exp Surgical Procedures, Operative 10. General Surgery/ 11. surg*.mp 12. operat*.mp PATIENT REPORTED OUTCOME 1. Health Status/or geriatric assessment/ 2. Health Status.mp 3. Health related quality of life.mp 4. HRQL.mp 5. HRQOL.mp 6. Quality of life/ 7. Quality of life.mp 8. Patient reported outcome*.mp 9. Well being.mp 10. Self report/ 13. exp Anesthesia, general 14. exp Anesthesia 15. Anesthesiology/ 16. An?esthe* Table 1: List of keywords used. (exp = exploded term, mp = keyword) Study Selection Studies will be selected following screening of the articles title and abstract. They will be rejected where they are clearly unrelated to the review question e.g. no operative procedure performed. Studies in which there is uncertainty about whether or not the inclusion criteria have been met will be obtained in full detail, and further analysed against the inclusion/exclusion criteria. Only studies on >100 patients will be included. Data Extraction 1) Studies selected from the primary search will be listed in an Excel Spreadsheet under the following titles: a. Author b. Date of publication c. Study title d. Number of patients in study e. Operative procedure undertaken e.g. hip replacement f. HRQOL PROM tool(s) used

4 g. Whether baseline PROM was performed (Y/N), and at what time interval the PROM was repeated post- operatively (e.g. 6 months) One researcher will perform the initial search. Data extraction will be done by two researchers. Discrepancies will be resolved by consultation between the initial two researchers. Where consensus opinion cannot be reached, a third researcher will be consulted. Data Synthesis and Quality Assessment Each PROM tool that is identified in the perioperative literature will be assessed for its quality according to eight criteria as stipulated by the review Evaluating patient- based outcome measures for use in clinical trials by Fitzpatrick et al (8). (This will be done through citation searching using Web of Science as mentioned above.) The information captured to assess the quality of the PROM tool will be as follows: a) Name of PROM b) Total number of dimensions in PROM tool c) Total number of questions in PROM tool d) Author(s) of original paper e) Date of publication: Original paper f) Single or multicentre study g) Country of origin h) Surgical setting (type of surgery and intervention) i) Number of patients used to validate PROM: Original paper and further validation studies. j) Appropriateness has the author considered how the tool used to measure HRQOL matches the purpose of the study? k) Reliability are the results using the PROM tool, reproducible and consistent? l) Validity does the PROM tool indeed measure what it is meant to? m) Responsiveness is the PROM tool sensitive to changes of importance to patients n) Precision the number and accuracy of distinctions made by an instrument (?) o) Interpretability how meaningful are the scores from using this PROM tool? p) Acceptability how acceptable is this PROM tool for respondents to complete? q) Feasibility what kind of effort/burden/disruption arises from the use of this PROM tool? This review will be evaluating the quality and validity of the measures, rather than the patient outcomes therefore a narrative synthesis is planned. Dissemination This protocol is registered in PROSPERO. The results of this systematic review will be sent for publication in a peer- reviewed journal.

5 Dummy example of data extraction table to show the studies that have used a generic PROM to assess HRQoL What PROM s exist to measure HRQoL in the perioperative literature? AUTHOR PUB DATE PT NO OPERATION PROM Abdel Rafee et al Hepaticojejunostomy SF8 y Arms et al Baseline measure? Post- op follow up 6 months Robotic surgery for gynaecological indication SF- 12 y 1 year Dummy example of data extraction table to show original development studies for each PROM and subsequent validation studies (dummy example) Validity of PROMs in used in the perioperative literature PROM NAME NUMBER OF NUMBER OF 1 ST + LAST AUTHOR YEAR SINGLE/MU LTI- CENTRE GEOGRAPHI CAL LOCATION SURGICAL SETTING NO OF PATIENTS APPROPRIA TENESS RELIABILITY VALIDITY RESPONSIV ENESS RPECISION INTERPRETA BILITY ACCEPTABIL ITY FEASIBILITY EQ5D 5 5 Stevenson and Turpin EQ5D 5 5 Cook and Myles 2006 S UK Colorectal 200 Y NA Y Y Y Y Y Y 2013 M International (Europe only) Colorectal, upper GI, head and neck cancer 1500 NA Y Y N Y NA Y Y

6 References 1. Phillips N. Berry & Kohn s Operating Room Technique. 10th ed. St Louis: Mosby; International Society for Quality of Life Research (ISOQOL). Health- Related Quality of Life Research: What is Health- Related Quality of Life? [Internet]. [cited 2016 Feb 28]. Available from: isoqol/what- is- health- related- quality- of- life- research 3. Guyatt GH, Feeny DH, Patrick DL. Measuring health- related quality of life. Ann Intern Med Apr 15;118(8): Gibbons E, PROM group. Instrument Types (PROMs) [Internet]. [cited 2016 Feb 28]. Available from: 5. Ferrans CE. Outcomes Assessment in Cancer: Measures, Methods and Applications [Internet]. Cambridge University Press; p. 6. Barnett SF, Alagar RK, Grocott MPW, Giannaris S, Dick JR, Moonesinghe SR. Patient- Satisfaction Measures in Anesthesia: Qualitative Systematic Review. Anesthesiology. 2013;119(2): Coulman KD, Abdelrahman T, Owen- Smith a, Andrews RC, Welbourn R, Blazeby JM. Patient- reported outcomes in bariatric surgery: a systematic review of standards of reporting. Obes Rev. 2013;(September): Fitzpatrick R, Fitzpatrick R, Davey C, Davey C, Buxton MJ, Buxton MJ, et al. Evaluating patient- based outcome measures for use in clinical trials. Health Technol Assess (Rockv). 1998;2(14):i iv, 1 74.