How to select and understand guidelines for patient-reported outcomes? Scoping review of existing guidelines

doi:10.21203/rs.3.rs-2583857/v1

Background

Patient-reported outcomes (PROs), which are health outcomes subjectively provided by patients, have been used in various situations over the past decades as tools to understand patients’ health conditions, and accordingly, numerous PRO questionnaires and guidelines have been developed. In this study, existing PRO guidelines for clinical trials and practice were comprehensively collected to support novice PRO users in academia, industry, clinical practice, regulatory and reimbursement decision-making.

Methods

For the scoping review, we searched databases including MEDLINE, Embase, Google Books, WorldCat, and the National Library of Medicine (NLM) Bookshelf from 2009 to 2020. The inclusion criteria were PRO guidelines for clinical trials/practice and application/utilization, which included quality of life (QOL), PRO, health-related QOL, or health state utilities related to psychometric requirements, collection method and analysis, and clinical interpretation. After the systematic search, three members individually reviewed the data collected, and the reviewed articles and books were scrutinized for the same criteria.

Results

The PRO guidelines published in articles and books between 2009 and 2020 were collected. From the database searches, 1,039 articles and 296 books were selected, of which one book and 25 articles were finally selected. A total of 16 guidelines from articles and books on clinical trials covered issues such as design/reporting, questionnaire preparation, and collection methods, including ePRO, analysis, and clinical interpretation. Five of these covered PRO assessment and application in clinical practice. One PRO guideline was published to inform decision-making such as health technology assessment.

Conclusions

This scoping review classified existing PRO guidelines by stage (evaluation or application), setting (clinical trials/practice), and evaluation process. The classification and summary would facilitate beginners’ judgment in the selection and explanation of terms used in the guidelines would enhance understanding of existing PRO guidelines.

patient-reported outcomes

PRO guidelines

PRO recommendations

PRO checklist

clinical outcome assessment

Traditionally, healthcare has relied on objective evaluation as a biomedical, integrated outcome or assessment by clinicians. However, differences have been reported between subjective and objective assessments of symptoms such as fatigue, pain, and sexual, urinary, and bowel dysfunction in prostate cancer patients [1], chemotherapy-induced peripheral neuropathy in breast cancer [2], general cancer quality-of-life (QOL) assessment in palliative care [3], and the understanding of adverse events (AEs) in anticancer therapy [4].

Subjective self-evaluations by patients have been used in various situations over the past 50 years as a tool to understand patients' health conditions. Numerous questionnaires [5] and guidelines [6] on the same have been developed and published over the years. Although the term patient-reported outcome (PRO) was originally defined as an outcome measure for clinical trials by pharmaceuticals [7], it is now widely used in clinical practice and health technology assessment (HTA) and reimbursement processes [8].

Guidelines on the use of PROs in clinical trials for labeling claims were issued by the US Food and Drug Administration (FDA) in 2009 [9]. Prior to that, in 2005, the European Medicines Agency (EMA) issued guidelines on QOL measurement in drug applications [10]. The EMA released its guidelines on PRO measures in the evaluation of cancer drugs [11] in 2016 after the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) published a consensus paper on PRO measurements and clinical outcome assessments (COAs) based on years of discussions regarding HTA [12].

PRO assessments in clinical practice have been recognized as tools for evaluating patient health conditions. Greenhalgh [13], for example, suggested that PRO assessment in clinical practice can be used to screen health problems, monitor long-term progress, and facilitate patient-centered care. The International Society for Quality of Life Research (ISOQOL) has summarized existing reports from clinical practice into best PRO practices (e.g., PRO assessment in clinical practice improves patient-clinician communication, is used to make clinical decisions, and enhances patient care and outcomes), and issued them as a user guide [14] in 2011. The use of PRO in clinical practice is expansive since PROs measured in clinical trials can facilitate clinical decisions based on existing literature on clinical practice guidelines.

PRO evaluations, which have long been conducted on paper, can now be conducted on electronic media/terminals due to advances in information and communication technology (ICT). These electronic PRO evaluations are collectively referred to as electronic PRO (ePRO) and are treated as part of electronic source data in clinical trials [15–17]. In addition, ICT-based PROs have been used in routine clinical practice by the National Health Service in the United Kingdom [14] and the Health Information Research Agency in Canada [18] to assess value of care and improve quality of care.

PROs measured in clinical trials are applied not only for drug applications but also for decision-making, such as reimbursement decisions [8]. Therefore, the involvement of patients in each process is considered important to reaffirm the fundamental question of "what matters" among all involved [19].

Because various guidelines have been published for PROs used in such a variety of situations, it is often challenging for beginners to select and implement the desired guideline in a specific situation. Therefore, in this study, existing PRO guidelines for clinical trials and practice were comprehensively collected to support novice PRO users in academia, industry, clinical practice, regulatory and reimbursement decision-making.

A scoping literature review was undertaken using a set of eligibility criteria and a search strategy to examine the style, purpose, and targets of the PRO guidelines. Direct inquiries were made to experts in the field and the reference lists of the collected studies were scrutinized to reinforce comprehensiveness. Because the current study is an exploratory study, no prior protocol was developed or registered.

Eligibility criteria

First, the style of the guidelines was examined by searching for guidelines, guidebooks, task force reports, recommendations, and declarations. Second, the purpose of the guidelines was confirmed using the following search terms: clinical practice, clinical study, clinical trial, psychometrics, validation, translation, item response theory, differential item functioning, clinical interpretation, minimum important difference (MID), minimal clinically important difference (MCID), meaningful change, analysis, missing data, ePRO, monitoring, ethics, labeling claims, and health technology assessment (HTA) (For a taxonomy of the above terms, please see Appendix I). The terminology for the above terms was extracted by TK from items addressed in the guidelines [9–11, 14] and books on PRO or quality of life [20–23] and determined through discussions with MN and KS. Finally, PROs covered by the guidelines were identified using search terms such as quality of life (QOL), patient-reported outcome (PRO), health-related quality of life (HRQL or HRQoL), and health state utilities. Although many disease-specific PRO guidelines were anticipated, disease-, region/country-, and race-specific guidelines were not included in this study to ensure comprehensiveness. As an exception, only oncology-related PRO guidelines with a long history of PRO evaluation were included in this review to examine the existing guidelines.

Data source and search strategy

We developed a comprehensive search strategy for academic articles and books in collaboration with an information specialist (KS). Since a wide variety of report formats to be reviewed in electronic or printed format, such as a single publication in the form of a book/report, an article in an academic journal, a report with a unique subject, or part of a chapter), was expected, we comprehensively searched for reports, including databases that did not exclusively cover academic publications.

For academic articles, we searched MEDLINE and Embase for reports published in 2009, when the FDA’s PRO measure user guide was issued, and thereafter. We searched Google Books, WorldCat, and the National Library of Medicine (NLM) Bookshelf for reports after the year following the publication of the EMA guidelines in 2016 [11], to account for timely information updates in the area. Searches were performed on October 28, 2020, for MEDLINE and Embase; September 24, 2020, for Web of Science; October 22, 2020, for WorldCat and NLM Bookshelf; and October 25, 2020, for Google Books. (See Appendix I)

After the systematic search, reference lists of the collected studies were scrutinized and the ISOQOL Japan Special Interest Group (SIG) members (SY, TY, KT, MT) were consulted via email if there were any other important PRO guidelines, and the resulting candidates were added to the following process as other sources.

Guidelines selection

Academic articles were reviewed by three members (SK, NM, and KT), and books were reviewed by three members (NM, HE, and KT). In the review, we first removed duplicate articles or book information and then the first reviewer screened all citations (title and abstract for articles, and title and table of contents for books) to determine their eligibility for the current study. A second reviewer screened the citations independently and the two reviewers discussed the screening results. For the article/book information on which the two reviewers did not reach an agreement, a third reviewer (NM) was included in the discussion to reach a consensus on the article/book information to be adopted. All reviewed articles and books were scrutinized using the same criteria.

Summary of review results

The collected PRO guidelines were classified by stage (evaluation or application), setting (clinical trial or clinical practice), and evaluation process (design/reporting, questionnaire preparation, collection method and analysis, clinical interpretation, or feedback) through discussions among the four co-authors (SK, NM, EH, and KT). Subsequently, summarized information for each stage, setting, and process across the guidelines was obtained.

Study Selection

A total of 1,030 articles were identified in the PRO guidelines search, and after removing duplicates with other sources such as additional records from experts, a total of 1,039 titles and abstracts were reviewed. After full-text reviews of 65 articles, 41 articles were found to have satisfied the inclusion criteria. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flowchart in Figure 1a shows the process of selecting the article information. Regarding books, a total of 490 books were identified, and 296 titles and abstracts were selected after removing duplicates. As a result of full-text reviews of the 37 books, six books were found to have satisfied the inclusion criteria. The PRISMA flowchart in Figure 1b shows the process of selecting the books. In the combined review of the articles and books, we re-evaluated them from the perspective of guidelines not intended for specialists, and ultimately, incorporated information from 25 articles and one book into this study.

Overview of guidelines

Since the issuance of the FDA’s PRO guidelines in 2009 [9], the number of issued guidelines has increased (see Figure 2, years of publication). From 2009 to 2016, a total of 11 PRO guidelines were published. However, in 2017, the year after the issuance of the EMA PRO guidelines [11], a total of 14 PRO guidelines were published. Table 1 provides an overview of the articles and books included in this study. The selected guideline designations were guidelines (n = 6) [11,24,25,26,27,28], recommendations (n = 6) [29,30,31,32,33,34], guides [35,36], task force reports [37,38], educational reviews [39,40] (all n = 2), and guidance [41], that were used as search terms, while expert-recommended guideline designations were checklists [42] and reflection papers [43] (both n = 1). Guidelines on clinical trials were 16 in number and covered a wide range of PRO measurement processes such as design and reporting (n = 8) [11,25,29,27,39,35,36,41], questionnaire preparation (n = 14) [11,24,43,29,30,31,27,44,32,37,35,40,36,41], collection method including ePRO and analysis (n =11) [11,44,32,33,34,39,28,35,40,36,41], and clinical interpretation (n = 5) [11,39,28,35,36]. However, five guidelines on clinical practice [26,35,36,40,42] that cover a wide range of PRO processes, from PRO assessment design to feedback, treatment choice, and electronic health records, although they omit detailed descriptions of the PRO analysis, were included. Guidelines on the application of PRO in decision-making, such as HTA [38], comprised one study. Finally, the pilot selected two disease-specific PRO guidelines: one was related to the clinical interpretation of PRO (MID or MCID) in clinical trials [28] and the other was an educational review for integrating PRO into daily clinical practice [40].

Summary of review results

The collected PRO guidelines were classified according to the stage (evaluation or application for decision-making) of evaluation (clinical trial or clinical practice) and evaluation process (design, questionnaire preparation, collection method and analysis, clinical interpretation of the results, or feedback). Their brief descriptions are as follows:

1. PRO measure in clinical trials and research

1.1 Design and report of research using PRO

The design and reporting of clinical trials are inextricably linked [11]. After the Consolidated Standards of Reporting Trials (CONSORT) Group published its reporting format for clinical trial results in 1996, the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Group issued a statement on clinical trial protocols in 2013. The two groups have been updating and extending the items in coordination with each other, and extensions to the PRO measures were provided in 2013 [24] and 2018 [25] (see Appendix II for details on the extended items by CONSORT-PRO and SPIRIT-PRO).

1.2 Questionnaire preparation for research using PRO

1.2.1 Qualitative research and survey instrument development

Qualitative research involving patients' subjectivity and experiences can serve as the basis for providing scientific evidence to complement the research [45]. Qualitative research is also adopted as a procedure in a series of instrument development procedures to validate the conceptual framework, item creation, and content validity of scales [9], and in self-report by interview, provided that the interviewer records only patient responses [11]. The Standards for Reporting Qualitative Research: A Synthesis of Recommendations [46] and Consolidated Standards for Reporting Qualitative Research [47] have been developed to facilitate qualitative research.

1.2.2 Copyright issues and translation

Several PRO questionnaires have been developed and owned by third parties. Therefore, it is important to first check with the owner of the instrument if translation is possible and then obtain a license and author's agreement [43]. General guidelines for the translation of PRO questionnaires [48] have been provided by the ISPOR Task Force and are referred to in the guidelines of the FDA [9] and EMA [11]. However, several issues need to be considered even for questionnaires in the same language for multinational clinical trials, and Wild et al. [29] have summarized recommendations for them. McKown et al. [30] pointed out that considerations in the translation of PRO questionnaires have an impact on other elements of COAs.

1.2.3 Selection of PRO measures

What are the minimum requirements for the selection of PRO measures? The ISOQOL scientific advisory task force listed the following requirements [31] for the selection of PRO measures: 1) conceptual and measurement model, 2) evidence for reliability 3) content validity, 4) construct validity, 5) responsiveness, 6) interpretability of scores, 7) quality translation, and 8) acceptable patient and investigator burden. Crossnohere et al. [49] compared the above requirements with other regulatory guidelines [9, 11, 31] and developed the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines [26,27,50,51] as core indicators of PRO measure selection.

1.3 Collection method and analysisof research using PRO

1.3.1 ePRO

PROs used in clinical trials and research are increasingly electronic PROs (ePROs), with references in the FDA [9] and EMA guidance [11], and four of the 16guidelines in this review were specific to ePRO. Byrom and Muehlhausen [44] summarized the following essential components of ePRO: ePRO design, migration validity consideration [32], language processing, system validation [37] when conducting ePRO assessments, training of users [33], and "Bring Your Own Device (BYOD)."

1.3.2 PRO assessments collecting safety information

Although drug safety information is already collected during the clinical trial phase, the systematic collection of PRO assessments in the post-marketing phase is limited, except in oncology. Therefore, Banerjee et al. [41] proposed a framework for defining, collecting, and analyzing post-marketing adverse events by refining the PRO measurement methods adopted in clinical trials.

1.3.3 Analysis in research using PRO

Although the guidelines for trial design and reporting are provided in Section 1.1, it is important to note that Coen et al. [34] categorized the remaining challenges using the example of interpreting the results of clinical trials in cancer specific to PRO measurement, including the taxonomy of study objectives, statistical methods consistent with objectives, definition and management of missing data, and providing recommendations for addressing them.

1.4 Clinical interpretation

PRO guidelines [9,11] recommend the use of predefined measures (anchors) to facilitate a reasonable definition of "response" and "deterioration" in individual patients and the interpretation of PRO data. Wyrwich et al. [39] cautioned that the cumulative distribution function of the response recommended in the FDA guidance [9] cannot replace anchor-based methods. Cocks et al. [28] provided examples of the clinical significance and interpretation of major changes based on these definitions in their meta-analysis of clinical trials using data from the European Organization for Research and Treatment of Cancer (EORTC) the Quality-of-Life Questionnaire Core 30 (QLQ-C30).

2．PRO assessment in clinical practice

2.1. From design to feedback of PRO assessment

Following the creation of a 'User's Guide to Implementing PRO Assessment in Clinical Practice' [14] by ISOQOL in 2011, revised in 2015[52], a Companion Guide [35] was released to assist PRO assessment implementations in clinical practice and overcome implementation challenges based on information from a semi-structured survey or telephone interview.

Both guides consisted of: 1) identifying the goals for collecting PROs, 2) selecting patients and settings, 3) determining which questionnaire(s) to use, 4) selecting the timing of assessments, 5) choosing a mode for administering and scoring the questionnaire, 6) identifying aids to facilitate score interpretation, 7) designing processes for reporting results, 8) developing strategies for responding to issues identified by the questionnaires, and 9) evaluating the impact of PRO assessment on clinical practice.

2.2 PRO for clinical decision-making

In Section 2.1, in addition to the assessment of PROs for individual patients, an application of the results was presented as "responding to issues identified by the questionnaires."[14,35,52]. However, guidelines for the application of PRO measured in clinical trials to routine clinical practice have been identified by Wu et al. [42] recommending the use of PRO reporting literature and COSMIN guidelines [26,51] for systematic reviews.

2.3 Embracing PRO in routine clinical practice

As indicated in a series of ISPOR guidelines [14,35,52], Ivatury et al. [40] summarized how to incorporate PRO into routine clinical practice, specifically in an educational review of instrument selection, delivery methods, frequency of inquiries, and costs and resources for the systematic collection of PROs. Snyder et al. [36] summarized the integration of PRO into electronic health records (EHRs) as a system of guidelines covering strategies, training, and assessment, as well as administrative, ethical, and legal considerations.

3．PRO application for decision-making

Decisions are made using PROs in the context of reimbursements through HTA. Haywood et al. [45] described eight key stages in the development of PRO measures used in HTA and discussed ways to involve patients in the process. Many clinical studies employing PRO measures do not include preference-based measures (PBMs) to calculate the required utilities for HTA and lack a relevant preference-based scoring system. Mapping aims to fill these evidence gaps, and the ISPOR Task force [38,53] has provided detailed guidance regarding the procedure.

While many previous studies have touched upon existing PRO guidelines[6, 8, 31, 49], an understanding of seemingly simple terminology is essential for utilizing the PRO guidelines effectively. This section outlines PRO-related keywords that may be stumbling blocks for novice PRO users, including their references in the guidelines.

PRO/HRQL/HRQoL

As mentioned previously, PRO in multinational clinical trials is currently treated as one of the attributes of COA and a concept that includes HRQL [7,11,54]. However, both concepts differ in clinical practice [14] and research [55] and cannot be used in the same way (e.g., proxy evaluations employed in HRQL are considered inappropriate for PRO [9, 11]). The term health-related QOL is also often used differently, with the abbreviations HRQL and HRQoL depending on the stage at which it is used. Details are given in the next section, but PRO beginners should note that the former has the connotation of measuring health, while the latter has the connotation of valuing health.

Measurement or Valuation of Health

A common source of confusion for economists and health researchers is the distinction between the measurement and valuation of health [56]. The guidelines for mapping [38] and the MApping onto Preference-based measures reporting Standards (MAPS) statement [57] bridge the gap between the two. PBMs measuring HRQoL in decision-making are sometimes described as PROs [9, 58], and therefore, it is necessary to refer to the definition of PRO in the relevant guidelines.

Minimal Clinically Important Difference

As Bottomley et al. [58] described in their review of regulatory guidance [9,10], an important issue in PRO measurement is interpreting the results using not only statistical significance tests but also clinically meaningful score differences or changes over time, which are described in the guidelines as MID or MCID [28, 59, 60], meaningful change or difference [28,61], the ability of PRO measures to detect change [9, 50], interpreting change [58], or responder definition [9], but are synonymous. Overall, it is advisable to predefine MID, MCID, and responders when planning a PRO study.

Response Shift

Response shift is the phenomenon of unintended deviations in PRO measurement results. Cocks et al. [28] reported that mean changes in EORTC QLQ-C30 scores were generally small in most clinical situations, possibly due to a response shift. Although response shifts have been treated as distorting results in clinical trials, Sajobi et al. [62], in a review of statistical methods to detect response shifts, stated that response shifts do not necessarily have negative implications in clinical settings (e.g., they may be the result of coping [63]). However, no clinical practice guidelines were found to mention response shifts in this study.

Although the present study reveals important findings, it is not without limitations. One limitation of this study is that disease-specific guidelines were excluded from the analysis. However, in a 2013 review of guideline documents dated from 1989 to 2013 by the SPIRIT-PRO Group, with the majority focusing on HRQL/PRO assessment in cancer trials, a total of 21,175 reports were eligible for screening after deduplication [6]. However, considering the feasibility of this study in collating a comprehensive set of PRO guidelines, the inclusion of disease-specific guidelines could have unnecessarily increased the number of participants to be reviewed. Although the current research employed a comprehensive strategy that spanned both scholarly articles and book information, the titles of the guidelines were sometimes expressed as checklists, tools, frameworks, or forms other than the set keywords. The desired guidelines can be obtained more efficiently by adding them to the keyword-selection process. However, the issue of setting such keywords was addressed by consulting with ISOQOL Japan SIG members, with reference to the statement “We also obtained relevant articles through a request to the ISOQOL membership email distribution list” [31]. Given that the audience for this scoping review is likely to be those who need a comprehensive reference point for their choice of PRO guidelines, guidance on technical details (too narrow in scope), or guidance that merely uses PRO as one of the healthcare system evaluation data sets (too broad in scope) were excluded from the scope of this study. Although some guidelines related to COA were present in the collected articles, we decided to focus solely on consolidating, examining, and discussing the information collected by the search, leaving a detailed review of COA to other reports. Hollin et al. [45] cited PRO guidelines and recommended that qualitative studies enhance the relevance of preference evidence. While the significance of qualitative studies was applied to this study (Section 1.2.1), patient preference information (PPI) itself was outside the scope of this study and was ultimately excluded, as was PPI for device [64]. In the selection of PRO measures (Section 1.2.3), the reports obtained as a result of the search [26,27] included recommendations from the Core Outcome Measures in Effectiveness Trials (COMET) initiative [65] and Outcome Measures in Rheumatology (OMERACT) [66] handbook; therefore, we decided not to address each of them separately in this review because of space limitations. Since the literature search was performed in 2009 when the FDA’s PRO guidance was issued, this study excluded the Strengthening the Reporting of Observational Studies in Epidemiology Statement (STROBE) [67], a guide for reporting observational studies. However, the Journal of Patient-reported Outcomes recommends the use of STROBE for reporting observational studies in their author guidance [68], and similar to the PRO Ethical Guidelines [69], it should be considered for future PRO studies.

The current scoping review provided an overview of existing PRO guidelines categorized by stage (evaluation or application), setting of evaluation (clinical trial or clinical practice), and evaluation process (design and reporting, questionnaire preparation, collection method and analysis, clinical interpretation, or feedback). Guidelines for PRO measurement in clinical trials and research to accurately collect, appropriately analyze and report are established, now that guidelines on ethics [69] have been published. However, PRO guidelines in clinical practice and in application are limited in number and further expansion through disease-specific guidelines, such as the European Society of Oncology PRO guidelines [70], are expected. The measurement of PRO in clinical trials should consider the conceptual definition and clinical interpretation of PRO in addition to the accuracy of PRO measurement. PRO assessment in clinical practice has various potential applications with ICT such as ePROs and EHRs, and the aggregated data with them would be expected to be utilized to examine the impact of the PRO assessment process on patient-physician communication and the positive impact of patient involvement. However, it is especially important for beginners in the field of PRO, to understand how the terminology is used in guidelines and whether what is referred to as PRO refers to symptoms, QOL or PBM at each stage, setting or process where PRO is used.

AEs: adverse events; BYOD: Bring your own device; COAs: Clinical Outcome Assessments; COMET: Core Outcome Measures in Effectiveness Trials; CONSORT: Consolidated Standards of Reporting Trials; COSMIN: COnsensus-based Standards for the selection of health Measurement Instruments; EHR: electric health record; EMA: European Medicines Agency; EORTC: European Organization for the Research and Treatment of Cancer; ePRO: electronic PRO; FDA: US Food and Drug Administration; HTA: health technology assessment; HRQL or HRQoL: health related quality of life; ICT: information and communication technology; ISPOR: International Society for Pharmacoeconomics and Outcomes Research; ISOQOL: International Society for Quality of Life Research; MID: minimum important difference; MCID: minimal clinically important change; NLM: National Library of Medicine; OMERACT: Outcome Measures in Rheumatology; PPI: patient preference information; PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses; PRO: patient-reported outcome; QLQ-C30: Quality of Life Questionnaire Core 30; QOL: quality of life; SIG: special interest group; SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials; STROBE: Strengthening the Reporting of Observational Studies in Epidemiology Statement

Ethics approval and consent to participate:

The Japanese Ethical Guidelines for Medical and Health Research Involving Human Subjects [71] do not require informed consent from patients to use published data.

Consent for publication:

Not applicable

Availability of data and materials:

The literature review data generated from this study are available upon request from the corresponding author.

Competing interests: The authors declare that they have no competing interests.

Funding:

This work was supported by the Ministry of Health, Labor and Welfare, Health Labor Sciences Research (Grant Number JPMH20AC1003).

Authors’ contributions:

KT conceptualized the review, developed search strategies, screened titles, abstracts, and full articles and books, extracted, classified, and summarized data, and created the drafts and final manuscript. HE screened titles, abstracts, and full books, advised on classification and summary data, supervised the review process, provided advice on any disagreement, and advised on classification and summary data. KS supported the selection of relevant databases and created combinations of search terms across academic articles and book information. MK supported the editing of the draft. SY, TY, KT, and TM provided suggestions regarding the data to be collected. NET confirmed the manuscript from the clinician's perspective. SK obtained research funding and supervised the entire process, including developing search strategies, reviewing titles, abstracts, and full-text articles, and advising on reporting style. The final manuscript has been read and approved by all authors.

Acknowledgements: Not applicable

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Wild D, Eremenco S, Mear I, et al. Multinational trials-recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: the ISPOR Patient-Reported Outcomes Translation and Linguistic Validation Good Research Practices Task Force report. Value Health. 2009;12(4):430-440. doi: 10.1111/j.1524-4733.2008.00471.x
McKown S, Acquadro C, Anfray C, et al. Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures. J Patient Rep Outcomes. 2020;4(1):89. doi: 10.1186/s41687-020-00248-z.
Reeve BB, Wyrwich KW, Wu AW, et al. ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research. Qual Life Res. 2013;22(8):1889-1905. doi: 10.1007/s11136-012-0344-y.
Muehlhausen W, Byrom B, Skerritt B, McCarthy M, McDowell B, Sohn J. Standards for Instrument Migration When Implementing Paper Patient-Reported Outcome Instruments Electronically: Recommendations from a Qualitative Synthesis of Cognitive Interview and Usability Studies. Value Health, 2018;21(1):41-48. doi: 10.1016/j.jval.2017.07.002
Ly JJ, Crescioni M, Eremenco S, et al. Training on the Use of Technology to Collect Patient-Reported Outcome Data Electronically in Clinical Trials: Best Practice Recommendations from the ePRO Consortium. Ther Innov Regul Sci. 2019;53(4):431-440. doi: 10.1177/2168479018796206.
Coens C, Pe M, Dueck AC, et al. International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomised controlled trials: recommendations of the SISAQOL Consortium. The Lancet Oncology. 2020; 21(2):e83-e96. doi: 10.1016/S1470-2045(19)30790-9.
Chan EKH, Edwards TC, Haywood K, Mikles SP, Newton L.Implementing patient-reported outcome measures in clinical practice: a companion guide to the ISOQOL user's guide. Qual Life Res. 2019;28(3): 621-627. doi: 10.1007/s11136-018-2048-4
Snyder C, and Wu AW ed. Users’ Guide to Integrating Patient-Reported Outcomes in Electronic Health Records. Baltimore, MD: Johns Hopkins University. 2017. http://www.pcori.org/document/users-guide-integrating-patient-reported-outcomes-electronic-health-records. Accessed 14 Feb 2022.
Zbrozek A, Hebert J, Gogates G, et al. Validation of electronic systems to collect patient-reported outcome (PRO) data-recommendations for clinical trial teams: report of the ISPOR ePRO systems validation good research practices task force. Value Health. 2013;16(4):480-489. doi: 10.1016/j.jval.2013.04.002.
Wailoo AJ, Hernandez-Alava M, Manca A, et al. Mapping to Estimate Health-State Utility from Non-Preference-Based Outcome Measures: An ISPOR Good Practices for Outcomes Research Task Force Report. Value Health.2017;20(1):18-27. doi: 10.1016/j.jval.2016.11.006.
Wyrwich KW, Norquist JM, Lenderking WR, Acaster S, Industry Advisory Committee of International Society for Quality of Life Research(ISOQOL.) Methods for interpreting change over time in patient-reported outcome measures. Qual Life Res, 2013;22(3):475-483. doi: 10.1007/s11136-012-0175-x.
Ivatury SJ, Hazard-Jenkins HW, Brooks GA, McCleary NJ, Wong SL, Schrag D. Translation of Patient-Reported Outcomes in Oncology Clinical Trials to Everyday Practice. Ann Surg Oncol. 2020;27(1):65-72. doi: 10.1245/s10434-019-07749-2.
Banerjee AK, Okun S, Edwards IR, et al. Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance. Drug Saf. 2013;36(12):1129-1149. doi: 10.1007/s40264-013-0113-z.
Wu AW, Bradford AN, Velanovich V, Sprangers MA, Brundage M, Snyder C. Clinician's checklist for reading and using an article about patient-reported outcomes. Mayo Clin Proc. 2014;89(5):653-661. doi: 10.1016/j.mayocp.2014.01.017.
Anfray C, Arnold B, Martin M, et al. Reflection paper on copyright, patient reported outcome instruments and their Translations. Health Qual Life Outcomes. 2018;16(1):224. doi: 10.1186/s12955-018-1050-4.
Byrom B and Muehlhausen W. Electronic Patient-Reported Outcome Measures: An Implementation Handbook For Clinical Research. 2018.
Hollin IL, Craig BM, Coast J, et al. Reporting Formative Qualitative Research to Support the Development of Quantitative Preference Study Protocols and Corresponding Survey Instruments: Guidelines for Authors and Reviewers. Patient. 2020;13(1):121-136. doi: 10.1007/s40271-019-00401-x.
O'Brien BC, Harris IB, Beckman TJ, Reed DA, Cook DA. Standards for reporting qualitative research: a synthesis of recommendations. Acad Med. 2014;89(9):1245-1251. doi: 10.1097/ACM.0000000000000388.
Tong A, Sainsbury P, Craig J. Consolidated criteria for reporting qualitative research (COREQ): a 32-item checklist for interviews and focus groups. Int J Qual Health Care. 2017;19(6):349-357. doi: 10.1093/intqhc/mzm042.
Wild D, Grove A, Martin ML, et al. ISPOR principles of good practice: the cross-cultural adaptation process for patientreported. Value Health. 2005;8:94–104..
Crossnohere NL, Brundage M, Calvert MJ, et al. International guidance on the selection of patient-reported outcome measures in clinical trials: a review. Qual Life Res. 2021;30(1):21-40. doi: 10.1007/s11136-020-02625-z.
US Department of Health and Human Services. Patient focused drug development: Collecting comprehensive and representative input, in draft guidance for industry, food and drug administration staff, and other stakeholders. Washington: US Department of Health and Human Services. 2018.
Mokkink, LB, deVet HCW, Prinsen CAC, et al. COSMIN risk of bias checklist for systematic reviews of patient-reported outcome measures. Quality of Life Research. 2018;27(5), 1171–1179. doi: 10.1007/s11136-017-1765-4
Aaronson N ET, Greenhalgh J, Halyard M, et al. User’s Guide to Implementing Patient-Reported Outcomes Assessment in Clinical Practice. 2015. https://www.isoqol.org/wp-content/uploads/2019/09/2015UsersGuide-Version2.pdf. Accessed 14 Feb 2022.
Wolowacz S. New ISPOR Recommendations - Mapping Methods for Estimation of Health State Utility. Value Health, 2017;20(1):28-29. doi: 10.1016/j.jval.2016.11.026
ICH Assembly. ICH Reflection paper Proposed ICH Guideline Work to Advance Patient Focused Drug Development. 2021. https://admin.ich.org/sites/default/files/2021-06/ICH_ReflectionPaper_PFDD_FinalRevisedPostConsultation_2021_0602.pdf. Accessed: June 5, 2021.
Costa DSJ, Mercieca-Bebber R, Rutherford C, Tait M-A, King MT. How is quality of life defined and assessed in published research? Qual Life Res. 2021;30(8):2109-2121. doi: 10.1007/s11136-021-02826-0.
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Petrou S, Rivero-Arias O, Dakin H, et al. The MAPS Reporting Statement for Studies Mapping onto Generic Preference-Based Outcome Measures: Explanation and Elaboration. Pharmacoeconomics. 2015;33(10):993-1011. doi: 10.1007/s40273-015-0312-9.
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Table 1. Overview of the articles and books

Title	Year	Author	Objectives	Ref#	Sec #
Articles
Patient-reported outcomes: assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency	2009	Bottomley A, et al.	Differences in the PRO/HRQL Guidance by FDA and EMEA	58	-
Multinational trials - Recommendations on the translations required, approaches to using the same language in different countries, and the approaches to support pooling the data: The ISPOR patient-reported outcomes translation and linguistic validation good research practices task force report	2009	Wild D, et al	Translation of PRO questionnaire and linguistic validation	29	1.2.2
Evidence-based guidelines for interpreting change scores for the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30	2012	Cocks K, et al.	Interpretation of PRO evaluation results (MID)	28	1.4
Methods for interpreting change over time in patient-reported outcome measures	2013	Wyrwich KW, et al.	Interpretation of PRO evaluation results (responsiveness）	39	1.4
Patient-reported outcome measures in safety event reporting: PROSPER consortium guidance	2013	Banerjee Ak, et al.	Use of PRO measures for AE reporting.	41	1.3.2
Reporting of Patient-Reported Outcomes in Randomized Trials: The CONSORT-PRO extension	2013	Calvert M, et al	Description of PRO measurement report	24	1.1
ISOQOL recommends minimum standards for patient-reported outcome measures used in patient-centered outcomes and comparative effectiveness research.	2013	Reeve BB, et al	Requirements for selecting a PRO measures	31	1.2.3
Validation of electronic systems to collect patient-reported outcome (PRO) data - Recommendations for clinical trial teams: Report of the ISPOR ePRO systems validation good research practices task force	2013	Zbrozek A, et al.	Requirements for ePRO systems validation	37	1.3.1
Clinician's checklist for reading and using an article about patient-reported outcomes.	2014	Wu AW, et al	Use of PRO assessment articles in clinical practice	42	2.2
Patient-reported outcome (PRO) assessment in clinical trials: A systematic review of guidance for trial protocol writers	2014	Calvert M, et al.	Current status of description of PRO measurement protocols	6	-
Appendix 2 to the Guideline on the evaluation of anticancer medicinal products in man. The use of patient-reported outcome (PRO) measures in oncology studies.	2016	European Medicines Agency.	Use of PRO measures for regulatory submissions in Europe (in cancer clinical trials)	11	1
Title	Year	Author	Objectives	Ref#	Sec#
Articles
How to select outcome measurement instruments for outcomes included in a "Core Outcome Set" - a practical guideline	2016	Prinsen CA, et al.	Clinical outcome selection	27	1.2.3
New ISPOR Recommendations - Mapping Methods for Estimation of Health State Utility/ Mapping to Estimate Health-State Utility from Non-Preference-Based Outcome Measures: An ISPOR Good Practices for Outcomes Research Task Force Report	2017	Wolowacz S, et al./Wailoo AJ, et al.	Mapping from non-preference based measure to utility	53,38	3
Users' Guide to Integrating Patient-Reported Outcomes in Electronic Health Records	2017	Snyder C, Wu AW, Ed.	Integrating PRO measures into electronic health records	36	2.3
Reflection paper on copyright, patient reported outcome instruments and their translations	2018	Anfray et al.	Copy right for PRO and its interpretation	43	1.2.2
Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension	2018	Calvert M, et al.	Description of PRO measurement protocol	25	1.1
Standards for Instrument Migration When Implementing Paper Patient-Reported Outcome Instruments Electronically: Recommendations from a Qualitative Synthesis of Cognitive Interview and Usability Studies	2018	Muehlhausen, W, et al.	Requirements for ePRO equivalence assessment	32	1.3.1
COSMIN guideline for systematic reviews of patient-reported outcome measures	2018	Prinsen CAC, et al.	Review methods for PRO evaluation reports	26	2.2
Scoping review of response shift methods: current reporting practices and recommendations	2018	Sajobi TT, et al.	Reliability of the PRO questionnaire (response shift)	62	-
Implementing patient-reported outcome measures in clinical practice: a companion guide to the ISOQOL user's guide	2019	Chan EKH, et al.	Application of PRO measurement to clinical practice	35	2.1, 2.2
Training on the Use of Technology to Collect Patient-Reported Outcome Data Electronically in Clinical Trials: Best Practice Recommendations from the ePRO Consortium	2019	Ly JJ, et al.	Use of ePRO in clinical trials	33	1.3.1
Good practices for the translation, cultural adaptation, and linguistic validation of clinician-reported outcome, observer-reported outcome, and performance outcome measures	2020	McKown S, et al.	Considerations for translating the COAs questionnaire	30	1.2.2
International standards for the analysis of quality-of-life and patient-reported outcome endpoints in cancer randomized controlled trials: recommendations of the SISAQOL Consortium	2020	Coens C, et al.	Statistical considerations in PRO measurement	34	1.3.3
Title	Year	Author	Objectives	Ref#	Sec#
Articles
Translation of Patient-Reported Outcomes in Oncology Clinical Trials to Everyday Practice	2020	Ivatury SJ, et al.	Application of PRO to clinical practice (from cancer clinical research)	40	2.3
International guidance on the selection of patient-reported outcome measures in clinical trials: a review	2021	Crossnohere NL, et al.	Requirements for selecting a PRO measures	49	-
Books
Electronic Patient-Reported Outcome Measures: An Implementation Handbook For Clinical Research	2018	Byrom B, Muehlhausen W	Entire landscape of ePROs	44	1.3.1

AEs: adverse events; COA: Clinical Outcome Assessments; CONSORT: Consolidated Standards of Reporting Trials; COSMIN: the COnsensus-based Standards for the selection of health Measurement Instruments; EMEA: European Medicines Evaluation Agency; ePRO: electronic PRO FDA: the US Food and Drug Administration; HRQL: health related quality of life; ISPOR: the International Society for Pharmacoeconomics and Outcomes Research; ISOQOL: the International Society for Quality of Life Research; MID or MCID: minimal clinically important change; PRO: patient-reported outcome; PROSPER: Patient-Reported Outcomes Safety Event Reporting; SISAQOL: the Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints Data; SPIRIT: Standard Protocol Items: Recommendations for Interventional Trials; Ref#: reference number; Sec#: section number

No competing interests reported.

PROGLSRappendix1SearchstrategyR2.docx
Appendix 1. Search strategy
PROGLSRappendix2PROspecificitemsinCONSORTSPIRITPRO.docx
Appendix 2. PRO-specific items in CONSORT-PRO and SPIRIT-PRO
PROGLSRappendix3CharacteristicsofsourceofevidenceFb.docx
Appendix 3. Characteristics of sources of evidence
PROGLSRappendix4PRISMAScR20192.docx
Appendix 4. PRISMA-ScR Checklist

How to select and understand guidelines for patient-reported outcomes? Scoping review of existing guidelines

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Background And Introduction

Methods

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Data source and search strategy

Guidelines selection

Summary of review results

Results

Discussion

Conclusion And Implications

Abbreviations

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Journal Publication

Version 1