Plain language summary
Introduction
Methods
Project launch and preparation
Delphi study
Workgroup meeting
Developing the guideline
Drafting the pre-final guideline
Pilot testing
End-of-project meeting
Results
Delphi study
Self-reported characteristic | Delphi study (total n = 109); n (%) | Workgroup meeting (total n = 24); n (%) |
---|---|---|
Primary perspective | ||
Academia | 94(86) | 18(75) |
Hospital | 4(4) | 1(4) |
Industry | 2(2) | 1(4) |
Government | 1(1) | 0(0) |
Editor | 1(1) | 0(0) |
Non-profit | 1(1) | 0(0) |
Patient | 4(4) | 3(13) |
Patient representative | 1(1) | 1(4) |
Public member | 1(1) | 0(0) |
Job titlea | ||
PhD student | 6(6) | 2(10) |
Research assistant | 2(2) | 1(5) |
Postdoctoral research fellow | 15(15) | 2(10) |
(Senior) researcher/research associate | 16(16) | 7(35) |
(Senior) lecturer | 7(7) | 0(0) |
(Assistant/associate) professor | 35(34) | 4(20) |
Clinician/therapist (various) | 12(12) | 1(5) |
Editor/reader/information specialist | 5(5) | 1(5) |
Director/dean/chair | 5(5) | 2(10) |
Country of workplaceb | ||
UK | 28(26) | 3(13) |
Canada | 27(25) | 16(67) |
USA | 15(14) | 2(8) |
Australia | 12(11) | 0(0) |
Spain | 9(8) | 0(0) |
Netherlands | 5(5) | 2(8) |
Italy | 3(3) | 1(4) |
Japan | 2(2) | 0(0) |
Otherc | 8(7) | 0(0) |
Relevant groupa, d | ||
OMI systematic review author | 78(76) | 12(60) |
Systematic review author | 66(64) | 13(65) |
OMI developer | 62(60) | 11(55) |
Clinician | 42(41) | 4(20) |
Core outcome set developer | 32(31) | 11(55) |
Epidemiologist | 21(20) | 11(55) |
Psychometrician/clinimetrician | 18(17) | 9(45) |
Journal editor | 17(17) | 4(20) |
Reporting guideline developer | 12(12) | 9(45) |
Biostatistician | 5(5) | 0(0) |
Highest level of educationa | ||
Master’s degree | 11(11) | 3(15) |
MD | 10(10) | 1(5) |
PhD | 56(54) | 12(60) |
MD/PhD | 26(25) | 4(20) |
Expertise on systematic reviews of OMIsa | ||
High | 57(55) | 11(55) |
Average | 41(40) | 8(40) |
Low | 5(5) | 1(5) |
Expertise on PRISMAa | ||
High | 60(58) | 12(60) |
Average | 36(35) | 4(20) |
Low | 7(7) | 4(20) |
Expertise on COSMINa | ||
High | 37(36) | 9(45) |
Average | 53(51) | 8(40) |
Low | 13(13) | 3(15) |
Previously involved in researche | ||
As participant | 5(58) | 4(100) |
As patient/public research partner | 6(100) | 4(100) |
Previously involved in methodological researche | ||
As participant | 2(33) | 2(50) |
As patient/public research partner | 4(67) | 3(75) |
Previously involved in a Delphi studye | 4(67) | 3(75) |
Workgroup meeting
Developing the guideline
Self-reported characteristic | Pilot testers (total n = 65); n (%) |
---|---|
Job title | |
(Post)graduate student | 3(5) |
PhD student | 19(29) |
Research assistant | 6(9) |
Postdoctoral research fellow | 4(6) |
(Senior) researcher/research associate | 7(11) |
(Senior) lecturer | 8(12) |
(Assistant) professor | 11(17) |
Clinician/therapist (various) | 7(11) |
Country of workplace | |
Brazil | 8(12) |
UK | 7(11) |
Canada | 6(9) |
Germany | 4(6) |
Belgium | 4(6) |
Mexico | 4(6) |
Australia | 3(5) |
The Netherlands | 3(5) |
Italy | 3(5) |
Spain | 3(5) |
China | 2(3) |
Iran | 2(3) |
Switzerland | 2(3) |
Turkey | 2(3) |
United states | 2(3) |
Othera | 10(15) |
Highest level of education | |
Bachelor’s degree | 3(5) |
Master’s degree | 21(32) |
MD | 21(32) |
PhD | 5(8) |
MD/PhD | 9(14) |
Other | 6(9) |
Participated in the Delphi study | |
Yes | 6(9) |
No | 59(91) |
Use of guidelineb | |
As a checklist after drafting the review | 55(93) |
As a writing tool during drafting the rewiew | 38(65) |
As a peer-review tool for someone else’s review | 14(24) |
As a teaching tool | 19(32) |
Review used for pilot testingc | |
Published | 13(22) |
Not yet published | 46(78) |
Role in review used for pilot testingc | |
First author | 45(76) |
Co-author | 8(14) |
PI/senior author | 6(10) |
Section and Topic | # | Checklist itema | Location |
---|---|---|---|
Title | |||
Title | 1 | Identify the report as a systematic review and include as applicable the following (in any order): outcome domain of interest, population of interest, name/type of OMIs of interest, and measurement properties of interest | |
Abstract | |||
Open Science | |||
Fundingb | 2.2 | Specify the primary source of funding for the review | |
Registration | 2.3 | Provide the register name and registration number | |
Background | |||
Objectives | 2.4 | Provide an explicit statement of the main objective(s) or question(s) the review addresses | |
Methods | |||
Eligibility criteria | 2.5 | Specify the inclusion and exclusion criteria for the review | |
Information sources | 2.6 | Specify the information sources (e.g., databases, registers) used to identify studies and the date when each was last searched | |
Risk of bias | 2.7 | Specify the methods used to assess risk of bias in the included studies | |
Measurement properties | 2.8 | Specify the methods used to rate the results of a measurement property | |
Synthesis methods | 2.9 | Specify the methods used to present and synthesize results | |
Results | |||
Included studies | 2.10 | Give the total number of included OMIs and study reports | |
Synthesis of results | 2.11 | Present the syntheses of results of OMIs, indicating the certainty of the evidence | |
Discussion | |||
Limitations of evidence | 2.12 | Provide a brief summary of the limitations of the evidence included in the review (e.g., study risk of bias, inconsistency, and imprecision) | |
Interpretation | 2.13 | Provide a general interpretation of the results and important implications | |
Plain Language Summary | |||
Plain language summary | 3 | If allowed by the journal, provide a plain language summary with background information and key findings | |
Open Science | |||
Registration and protocol | 4a | Provide registration information for the review, including register name and registration number, or state that the review was not registered | |
4b | Indicate where the review protocol can be accessed, or state that a protocol was not prepared | ||
4c | Describe and explain any amendments to information provided at registration or in the protocol | ||
Support | 5 | Describe sources of financial or non-financial support for the review, and the role of the funders in the review | |
Competing interests | 6 | Declare any competing interests of review authors | |
Availability of data, code, and other materials | 7 | Report which of the following are publicly available and where they can be found: template data collection forms; data extracted from included studies; data used for all analyses; analytic code; any other materials used in the review | |
Introduction | |||
Rationale | 8 | Describe the rationale for the review in the context of existing knowledge | |
Objectives | 9 | Provide an explicit statement of the objective(s) or question(s) the review addresses and include as applicable the following (in any order): outcome domain of interest, population of interest, name/type of OMIs of interest, and measurement properties of interest | |
Methods | |||
Followed guidelines | 10 | Specify, with references, the methodology and/or guidelines used to conduct the systematic review | |
Eligibility criteria | 11 | Specify the inclusion and exclusion criteria for the review | |
Information sources | 12 | Specify all databases, registers, preprint servers, websites, organizations, reference lists and other sources searched or consulted to identify studies. Specify the date when each source was last searched or consulted | |
Search strategy | 13 | Present the full search strategies for all databases, registers, and websites, including any filters and limits used | |
Selection process | 14 | Specify the methods used to decide whether a study met the inclusion criteria of the review, e.g., including how many reviewers screened each record and each report retrieved, whether they worked independently, and if applicable, details of automation tools/AI used in the process | |
Data collection process | 15 | Specify the methods used to collect data from reports, e.g., including how many reviewers collected data from each report, whether they worked independently, any processes for obtaining or confirming data from study investigators, and if applicable, details of automation tools/AI used in the process | |
Data items | 16 | List and define which data were extracted (e.g., characteristics of study populations and OMIs, measurement properties’ results, and aspects of feasibility and interpretability). Describe methods used to deal with any missing or unclear information | |
Study risk of bias assessment | 17 | Specify the methods used to assess risk of bias in the included studies, e.g., including details of the tool(s) used, how many reviewers assessed each study and whether they worked independently, and if applicable, details of automation tools/AI used in the process | |
Measurement properties | 18 | Specify the methods used to rate the results of a measurement property for each individual study and for the summarized or pooled results, e.g., including how many reviewers rated each study and whether they worked independently | |
Synthesis methods | 19a | Describe the processes used to decide which studies were eligible for each synthesis | |
19b | Describe any methods used to synthesize results | ||
19c | If applicable, describe any methods used to explore possible causes of inconsistency among study results (e.g., subgroup analysis) | ||
19d | If applicable, describe any sensitivity analyses conducted to assess robustness of the synthesized results | ||
Certainty assessment | 20 | Describe any methods used to assess certainty (or confidence) in the body of evidence | |
Formulating recommendations | 21 | If appropriate, describe any methods used to formulate recommendations regarding the suitability of OMIs for a particular use | |
Results | |||
Study selection | 22a | Describe the results of the search and selection process, from the number of records identified in the search to the number of study reports included in the review, ideally using a flow diagram. If applicable, also report the final number of OMIs included and the number of study reports relevant to each OMI. [T] | |
22b | Cite study reports that might appear to meet the inclusion criteria, but which were excluded, and explain why they were excluded | ||
OMI characteristics | 23a | Present characteristics of each included OMI, with appropriate references. [T] | |
23b | If applicable, present interpretability aspects for each included OMI. [T] | ||
23c | If applicable, present feasibility aspects for each included OMI. [T] | ||
Study characteristics | 24 | Cite each included study report evaluating one or more measurement properties and present its characteristics. [T] | |
Risk of bias in studies | 25 | Present assessments of risk of bias for each included study. [T] | |
Results of individual studies | 26 | For all measurement properties, present for each study: (a) the reported result and (b) the rating against quality criteria, ideally using structured tables or plots. [T] | |
Results of syntheses | 27a | Present results of all syntheses conducted. For each measurement property of an OMI, present: (a) the summarized or pooled result and (b) the overall rating against quality criteria. [T] | |
27b | If applicable, present results of all investigations of possible causes of inconsistency among study results | ||
27c | If applicable, present results of all sensitivity analyses conducted to assess the robustness of the synthesized results | ||
Certainty of evidence | 28 | Present assessments of certainty (or confidence) in the body of evidence for each measurement property of an OMI assessed. [T] | |
Recommendations | 29 | If appropriate, make recommendations for suitable OMIs for a particular use | |
Discussion | |||
Discussion | 30a | Provide a general interpretation of the results in the context of other evidence | |
30b | Discuss any limitations of the evidence included in the review | ||
30c | Discuss any limitations of the review processes used | ||
30d | Discuss implications of the results for practice, policy, and future research |
Systematic review A study design that uses explicit, systematic methods to collect data from primary studies, critically appraises the data, and synthesizes the findings descriptively or quantitatively in order to address a clearly formulated research question [65, 68, 69]. Typically, a systematic review includes a clearly stated objective, pre-defined eligibility criteria for primary studies, a systematic search that attempts to identify all studies that meet the eligibility criteria, risk of bias assessments of the included primary studies, and a systematic presentation and synthesis of findings of the included studies [65]. Systematic reviews can provide high quality evidence to guide decision making in healthcare, owing to the trustworthiness of the findings derived through systematic approaches that minimize bias [70] Outcome domain Refers to what is being measured (e.g., fatigue, physical function, blood glucose, pain) [1, 2]. Other terms include construct, concept, latent trait, factor, attribute Outcome measurement instrument (OMI) Refers to how the outcome is being measured, i.e., the OMI used to measure the outcome domain. Different types of OMIs exist such as questionnaires or patient-reported outcome measures (PROMs) and their variations, clinical rating scales, performance-based tests, laboratory tests, scores obtained through a physical examination or observations of an image, or responses to single questions [1, 2]. An OMI consists of a set of components and phases, i.e., ‘equipment’, ‘preparatory actions’, ‘collection of raw data’, ‘data processing and storage’, and ‘assignment of the score’ [57]. A specific type of OMIs is clinical outcome assessments (COAs) [71], which specifically focus on outcomes related to clinical conditions, often emphasizing the patient’s experience and perspective Report A document with information about a particular study or a particular OMI. It could be a journal article, preprint, conference abstract, study register entry, clinical study report, dissertation, unpublished manuscript, government report, or any other document providing relevant information such as a manual for an OMI or the PROM itself [68]. A study report is a document with information about a particular study like a journal article or a preprint Record The title and/or abstract of a report indexed in a database or website. Records that refer to the same report (such as the same journal article) are “duplicates” [68] Study The empirical investigation of a measurement property in a specific population, with a specific aim, design and analysis Quality The technical concept ‘quality’ is used to address three different aspects defined by COSMIN, OMERACT, and GRADE: 1) quality of the OMI refers to the measurement properties; 2) quality of the study refers to the risk of bias; and 3) quality of the evidence refers to the certainty assessment [2, 5, 72] Measurement properties The quality aspects of an OMI, referring to the validity, reliability, and responsiveness of the instrument’s score [64]. Each measurement property requires its own study design and statistical methods for evaluation. Different definitions for measurement properties are being used. COSMIN has a taxonomy with consensus-based definitions for measurement properties [64]. Another term for measurement properties is psychometric properties Feasibility The ease of application and the availability of an OMI, e.g., completion time, costs, licensing, length of an OMI, ease of administration, etc. [5, 26]. Feasibility is not a measurement property, but is important when selecting an OMI [2] Interpretability The degree to which one can assign meaning to scores or change in scores of an OMI in particular contexts (e.g., if a patient has a score of 80, what does this mean?) [64]. Norm scores, minimal important change and minimal important difference are also relevant concepts related to interpretability. Like feasibility, interpretability is not a measurement property, but is important to interpret the scores of an OMI and when selecting an OMI [2] Measurement properties’ results The findings of a study on a measurement property. Measurement properties’ results have different formats, depending on the measurement property. For example, reliability results might be the estimate of the intraclass correlation coefficient (ICC), or structural validity results might be the factor loadings of items to their respective scales and the percentage of variance explained Measurement properties’ ratings The comparison of measurement properties’ results against quality criteria, to give a judgement (i.e., rating) about the results. For example, the ICC of an OMI might be 0.75; this is the result. A quality criterion might prescribe that the ICC should be > 0.7. In this case the result (0.75) is thus rated to be sufficient Risk of bias Risk of bias refers to the potential that measurement properties’ results in primary studies systematically deviate from the truth due to methodological flaws in the design, conduct or analysis [68, 73]. Many tools have been developed to assess the risk of bias in primary studies. The COSMIN Risk of Bias checklist for PROMs was specifically developed to evaluate the risk of bias of primary studies on measurement properties [44]. It contains standards referring to design requirements and preferred statistical methods of primary studies on measurement properties, and is specifically intended for PROMs. The COSMIN Risk of Bias tool to assess the quality of studies on reliability or measurement error of OMIs can be used for any type of OMI [57] Synthesis Combining quantitative or qualitative results of two or more studies on the same measurement property and the same OMI. Results can be synthesized quantitatively or qualitatively. Meta-analysis is a statistical method to synthesize results. Although this can be done for some measurement properties (i.e., internal consistency, reliability, measurement error, construct validity, criterion validity, and responsiveness), it is not very common in systematic reviews of OMIs because the point estimates of the results are not used. Instead, the score obtained with an OMI is used. End-users therefore only need to know whether the result of a measurement property is sufficient or not. For some measurement properties it is not even possible to statistically synthesize the results by meta-analysis or pooling (i.e., content validity, structural validity, and cross-cultural validity/measurement invariance). In general, most often the robustness of the results is described (e.g., the found factor structure, the number of confirmed and unconfirmed hypotheses), or a range of the results is provided (e.g., the range of Cronbach’s alphas or ICCs) Certainty (or confidence) assessment Together with the synthesis, often an assessment of the certainty (or confidence) in the body of evidence is provided. Authors conduct such an assessment to reflect how certain (or confident) they are that the synthesized result is trustworthy. These assessments are often based on established criteria, which include the risk of bias, consistency of findings across studies, sample size, and directness of the result to the research question [2]. A common framework for the assessment of certainty (or confidence) is GRADE (Grading of Recommendations Assessment, Development, and Evaluation) [72]. A modified GRADE approach has been developed for communicating the certainty (or confidence) in systematic reviews of OMIs [2] OMI recommendations Systematic reviews of OMIs provide a comprehensive overview of the measurement properties of OMIs and support evidence-based recommendations for the selection of suitable OMIs for a particular use. Unlike systematic reviews of interventions, systematic reviews of OMIs often make recommendations about the suitability of OMIs for a particular use, although in some cases this might not be appropriate (e.g., if restricted by the funder). Making recommendations also facilitates much needed standardization in use of OMIs, although their quality and score interpretation might be context dependent. Making recommendations essentially involves conducting a synthesis at the level of the OMI, across different measurement properties, taking feasibility and interpretability into account as well. Various methods and tools for OMI recommendation exist (e.g., from COSMIN, OMERACT and others) [2, 74, 75] |