Improving the Reporting Quality of Instrument Cross-Cultural Adaptation: the IRICA Statement

Background: To achieve a consensus on the reporting checklists for instrument Cross-Cultural Adaptation (CCA) research. Methods: Firstly, we claried the research rationality with literature review and established the preliminary checklist pool based on information extracting. Then, using the focus group and expert interview, we optimized the checklists. Finally, the international Delphi surveys were conducted to evaluate the agreement degree, importance and familiarity of the checklists. In data analysis, 21 indicators were included for quantitative assessments, accompanied with group discussions. Results: A total of 61 articles was included for rational analysis and 70 items were extracted to establish the checklist pool. After focus group and experts interview research, a checklist draft contains 25 items was put forward. In the three-rounds of international Delphi surveys, 14(70.00%), 11(68.75%) and 11(68.75%) questionnaires were completed. Basing on the quantitative analysis and group discussions, 1, 1 and 9 items were deleted, added and modied. Finally, we formed the checklist for Improving the Reporting quality of Instrument cross-cultural adaptation (IRICA) which contains 24 items subhead under 6 sections: Title and structured summary, Rationale and Objective, Authorization, Participants Criteria, Forward Translations, Forward Synthesis, Backward Translations, Backward Synthesis, Experts Qualitative Review, Pilot Testing, Field Testing, Statistical methods, Participants, Series Instruments, Main results, Other analyses, Summary of evidence, Comparison of instruments, Limitations, Copyright owner interaction, Application attentions, Conclusions, Appendix, Funding. Conclusions: The IRICA statement can be used to guide users to report instrument CCA research in a standard manner, and assist to evaluate the reporting quality and study design.


Identify Expert panel
We identi ed the experts who have quality of life research, methodology, statistics, academic, and clinical backgrounds. The initial experts list was generated by pro ling the council members of the Association for Chinese Quality of Life (WACQOL), the International Society for Quality of Life Research Translation & Cultural Adaptation Special Interest Group and the Patient-Reported Outcomes Methods Group of Cochrane Collaboration with relevant expertise. Their name, title, institution, corresponding address and E-mail were collected. Experts with middle or higher (preferred) title grade, and two or more (preferred) backgrounds were primary identi ed for international Delphi survey. The geographical, reputation, and convenience were also considered. This study was approved by the Research Ethics Committees in First A liated Hospital of Guangzhou University of Chinese Medicine.
Conduct a Delphi survey E-mails containing the link to web-based survey and WORD format survey were distributed to all experts in the panel. And, the statements on informed consent for all experts were provided clearly in the second-round optimized checklists pool and corresponding survey questionnaire as 'This survey is free. However, to show your distinctive contribution to the study and our heartfelt appreciation, we will present your name, institution, et al. in the Experts Lists and Acknowledgment in our dissertation, articles and research summary for National Administration reviews, etc.. But if you DO NOT AGREE to present your personal information, please sign here: (If you 'agree', please ignore this question)' (Appendix 4 and 5), and in the third-round optimized checklists pool and corresponding survey questionnaire as 'Do you agree to list your name and institution in the acknowledgement in the articles to express our great appreciation for your contributions? 1=Agree ( ); 2=Disagree ( )' (Appendix 6 and 7). All the experts were weekly reminded with Email to complete the survey within one month until feedback was received. The survey in each round all contains the invitation, introduction and example, checklists and scores, open-ended questions, and socio-demographic questionnaire. Of those, experts answered the Agreement Degree for the checklists on a 3-Grade scale (Disagreement, Partial agreement, Total agreement), and the Familiarity and Importance on a 10-Likert scale (higher score indicates higher Familiarity and more importance), and could also choose to add free text comments for all open-ended questions. In the rst round, we provided the questionnaire with blank answer and reference; in the later rounds, the experts were given the questionnaires presented with the mean and standard deviation of the group's previous responses.
After the questionnaires returned in each round, data were scrutinized and transcribed by Author 3 into SPSS software and quantitative analyzed by Author 1.
This was followed by research group discussions, which gave participants the opportunity to collectively discuss emerging conclusions and recommendations. Correspondingly, these checklists were repeat amended on the basis of the mixed evidences and terminated once data saturated. With the attainment of consensus, the nal version for improving the reporting quality of instrument CCA (IRICA) was generated.

Data Analysis
Following 21 indicators in 5 data sets in-and between-rounds were included for quantitative analysis. 1) Experts' demographic and general information, including the age, gender, title, country/state, background, recall rate, and familiarity with checklists; 2) Level of central tendency for checklists, including the means, median, mode, sum, and totally agreement percentage; 3) Level of dispersion for checklists, including the standard deviation, percentiles 25, percentiles 75, and inter-quartile range (IQR); 4) Harmonious degree, including the coe cient of variation (CV), Kendall's coe cient of concordance, and the Cronbach's α of three domains (Agreement Degree, Importance, Familiarity) and total questionnaire; 5) Between-rounds variation, including the absolute difference in CV, and F-ratio. The free comments for open-ended questions in group discussions and Delphi surveys were summarized for qualitative reviews [17][18][19].
The checklist in each round of survey was 1) included directly without change if its Agreement Degree mean ≥2.00, Importance mean ≥8, totally agreement percentage ≥70%, both CVs ≤0.3, and no free comments involved; 2) deleted if its Agreement Degree mean ≤1.50, Importance mean ≤5, totally agreement percentage ≤30%, any of CVs >0.8, or many comments on deletion occurs; 3) modi ed in other situations. Data simultaneous met the following criteria means saturation and the Delphi survey terminated: IQR ≤1, F-ratio ≤1, the absolute difference in CV decreased with round increased, P Value of Kendall's W <0.05, and the total Cronbach'sα>0.7. All analysis were conducted with SPSS (version 17.0).  77] were included for analysis. Many studies excluded on the basis of the abstract described the guidance for clinical disease management, partial steps in CCA research, or studies no related to our aims, and so on. Of the 61 studies included in the study, almost all focused on the comprehensive research procedure or methods for instruments CCA or translation. So, to our best knowledge, little attention was given to the research reporting. As a result, the development of a consensus for instrument CCA reporting has been proposed by the research group as a solution to this problem.

Literature review and rational analysis
Establish and optimize the checklists pool Accompanied by the rational analysis, the information related to the reporting or writing for instrument CCA research were also extracted and coded. After winnowing and binning, 70 items in 9 sections were included rst in the checklists pool (Version 1, in Appendix 2). Then, the research group discussed the checklists one by one till a high degree of agreement was reached (July 2014, in Guangzhou), and an English version has 39 items and corresponding description was identi ed (Version 2, in Appendix 3). Then, the research advisers (Author 2, Author 4) evaluated the consistency of each researcher's comment in expert interviews (August 2014, in Guangzhou), and endorsed the selection of checklists for 26 items (Version 3, in Appendix 4). Two bilingual researchers (Author 3, Author 5) translated it into Chinese version until a high consensus was reached (Version 3, Chinese version in Appendix 5). Eight researchers engaged in the pilot test and discussed the item's comprehensive, operability, content, purpose, redundancy, clarity, etc. (February 2015, in Guangzhou), and renewed the questionnaire to 25 recommendation items with expert's opinions on the Agreement Degree, Importance, Familiarity and Other Advice, plus one open-ended question 'Do you have any comments on the modi cations to the checklist, and in particular any di culties you faced in giving an answer?', and a short socio-demographic questionnaire (Version 4, Chinese version in Appendix 6, and English version in Appendix 7). These surveys were transformed to web online version for international Delphi survey.

Identify Expert panel and Conduct a Delphi survey
We recruited a total of 20 experts on the panel and conducted 3 rounds surveys. 20, 16 and 16 questionnaires were respective distributed in each round and 14(70.00%), 11(68.75%) and 11(68.75%) questionnaires were completed and returned. The key characteristics of those who completed the Delphi survey are detailed in Table 1. The more exact socio-demographic characters and academic backgrounds were provided with Appendix 8. All the experts agreed to participate in the research and list their name and institution in the articles. Table 1 The socio-demographic characters and research background of experts participated in the international Delphi survey in three rounds. In round 1, 5 items met the modify criteria (item 13b, 17, 21, 22, 24, totally agreement percentage < 70% but > 30%, and item 22's importance mean < 8 but > 5), and 1 item met the deletion criteria (item 11, totally agreement percentage < 30%, and importance mean < 8 but > 5) based on the agreement degree analysis ( Table 2) and importance analysis ( discussion, the researchers deleted the item 11 ("Provide the research procedure and missions of international harmonization.") because of its poor total agreement percentage (28.57%), importance mean (7.46) and CV (0.327), and 3 advice for delete. Besides, according to the expert's advise, we divided item 3 ("Provide the translation agreement and ethics permission.") to item 3a and item 3b (added), and modi ed 7 items. Though the modi cations of item 13b, 17, 22 and 24 were required by the qualitative analysis and/or expert's advice, we only modi ed the items descriptions instead of stems because there were no adequate necessities based on acquired evidences.  As for rounds terminating analysis, although the IQR of total agreement percentage, P Value of Kendall's W and total Cronbach's α all met the terminate criteria (Table 4), the IQR of importance was not so satis ed (15 items did not met). In addition, a total of 41 free comments also indicated it needs further research (Table 5).  In round 2, 6 items met the modify criteria (item 9, 15, 17, 21, 22, 25, all the totally agreement percentage < 70% but > 30%) but no items met the deletion criteria (Table 2, and Table 3). And, 6 items received 6 advice (item 2b, 3b, 6, 13a, 13b, 22 with 1 advice) and 1 open comments. In group discussion, 2 items (Item 3b, 13b) were modi ed based on the expert's advice. The other items were modi ed with items description.
As for rounds terminating analysis, the IQR of total agreement percentage, P Value of Kendall's W and the total Cronbach'sα also met the terminate criteria (Table 4). However, the IQR of importance (7 items), F-ratio of agreement degree (9 items) and importance (7 items), absolute difference in CV of agreement degree (13 items) and importance (7 items) did not meet the terminate criteria. Because so many parameters fall in the unsaturated intervals, the research group believed the further research was needed.

Round 3
In round 3, 5 items met the modify criteria (item 14, 17, 21, 22, 24, all the totally agreement percentage < 70% but > 30%) but no items met the deletion criteria ( comments. In group discussion, the researchers did not modify the required items because all the advice could be added in the items description. As for rounds terminating analysis, the IQR of total agreement percentage, P Value of Kendall's W and the total Cronbach'sα also met the terminate criteria (Table 4). However, the IQR of importance (2 items), F-ratio of agreement degree (7 items) and importance (5 items), absolute difference in CV of agreement degree (14 items) and importance (5 items) did not meet the terminate criteria. Although some parameters indicated the information was not saturated, the numbers and differences are much less and smaller than former surveys. More importantly, the research group did not nd new information and codes from the expert's advice and comments for the reporting. So, the research group agreed to terminate the survey. All the changed information were detailed in Table 5.
The characters of the IRICA statement Synthesized all the documents, the authors discussed once more in July 2015 to optimize the descriptions of the checklist, and modi ed several words and sentences. Basing on the literature reviews, three-waves expert qualitative discussion and three-rounds international Delphi survey, the research group formed the nal version of IRICA statement (Improving the Reporting quality of Instrument Cross-cultural Adaptation) which contains 24 items subhead under 6 sections ( Table 6, and the Chinese Version in Appendix 10). Describe the objectives and characters of original instrument, and the necessity and bene ts for translation research. 2b State entire objectives of the research or speci c aim of a paper.

Authorization 3a
Provide the User-and Translation Agreement from the copyright owner, as well as the authorization date, types and obtaining method. Provide the missions, procedure and terminate criteria of experts qualitative review.
Pilot Testing 10 Provide the methods and procedure for data collection and analysis.
Field Testing 11 Provide the study design, setting, participants, data collection, administration, outcomes, instruments, sample size, etc. The internal consistency, content validity, construct validity and responsiveness must be provided.

Statistical methods 12a
Provide the scoring methods and its meanings.
12b Provide all the qualitative and quantitative variables, signi cant criteria and software.

Participants 13
Describe the detailed characters of researchers, experts and examinee in each step (a structured form is strongly recommended).

Series Instruments 14
Provide the detailed characters of different versions of translated instrument at each stage (a ow diagram is recommended).

Main results 15
Provide all the results pre-de ned in the protocol without publish biases. Otherwise, provide the obtaining methods for more detailed presentation.

Other analyses 16
Provide the exploratory analysis methods and results for unexpected situations.

Summary of evidence 17
Summarize all the positive and negative, qualitative and quantitative, con rmatory and exploratory ndings and clues.

Comparison of instruments 18
Longitudinal and parallel compare the differences among original instrument, target translation and other completed translations.

Discussion
The explanations of IRICA Section 1. Title and Abstract -item 1a: To concise and clear present the research information, the full name of original instrument, target language, research type and the role of article in series studies should be provided in the title. Of those, the research type can be indicated but not limited to words "cross cultural adaptation", "cross-cultural", "cultural adaptation", "translation" or "translating", etc.
-item 1b: Although the abstract format in different journals are variously, the translation aims, procedure and corresponding results, statistical methods, and psychological metrics in target language should be provided at least. -item 2b: Claim the objectives of the whole research and present manuscript.
Section 3. Methods -item 3a: Provide the authorization date and types of User-Agreement and Translation Agreement from the copyright owner or author. All the agreements must be obtained before the study beginning and listed in the article appendix. If the copyright is public or free, the authorization was not necessary, but it should be clari ed in the article.
-item 3b: Describe whether the study was approved by the ethical commission, and the commission name and approval date if yes.
-item 4: Provide the inclusion criteria and samples for researchers (education degree, specialty, language skills, standard operation procedure trained, etc.), experts (title grade, country/states, research background, etc.), examinee (age, gender, disease, consent, etc.) and their missions in each step. And note that the description of researchers and experts are usually ignored, so much attention should be paid on them.
-item 5-8: They are the core methods sets for CCA research, so the more detailed information the better. The different forward and back translation versions were recommended to being attached to the appendix.
-item 9: Describe the qualitative methods used for forward and back translation, for example, experts item review, focus group, nominal group, cognitive interview, et al. Provide their missions, saturation criteria, and inconsistent solutions.
-item 10-11: Provide the study design, setting, participants, data collection, administration, outcomes, instruments, sample size, etc.. The indicators and criteria for pilot test also should be described. In the psychological properties assessments, the internal consistency, content validity, construct validity and responsiveness must be provided. If applicable, the researcher should provide the test-retest reliability, inter-interviewer reliability, discriminative validity, criterion validity, interpretability, etc.
-item12: Firstly, provide the scoring methods of the translation instrument and its meanings, for instance, higher or lower scores indicate better or worse health status. And, provide all the qualitative and quantitative variables and signi cant criteria. In addition, the modern test theory eld is extremely quickly, so the item response theory, differential item functioning, equating and linking, response shift, etc. are also highly recommended. The software used in the analysis also should be clari ed.

Section 4. Results
-item 13: The researchers, experts and examinee participated in the complex research with various aims at different stages, their characters are so multiplex that authors usually intentionally or unintentionally ignored the reporting. This may decrease the research quality and result in many confusions on the information resource. Therefore, a structured form was highly recommended to providing their sociological and professional background characteristics (such as gender, age, title, occupation, geographic area, professional background, etc.) at different research stages (such as forward translation, backward translation, experts qualitative review, pilot Testing, eld Testing. etc.).
-item 14: Provide the detailed characters of different versions of translated instrument at each stage, including the instrument frame, items number, modi cations and related reasons. A ow diagram was recommended in the text or appendix.
-item 15: Provide all the results pre-de ned in the statistical protocol without publish biases, regardless positive or negative, good or bad. It is important to note that the psychological properties assessments in eld test are the core of instrument CCA research, so the more information the better. The routine analysis contains reliability, validity, responsiveness, interpretation, etc. If the researcher introduced the modern measurement theory, the model assumptions, model ts and item parameters estimation should be described clearly at least. If the publication does not allow for a detailed presentation, reference to a more detailed presentation elsewhere should be made, for example, availability of the full results from the authors or online, or publication of a separate paper. study, but the impact on the primary results needs to be presented. Although some experts claimed that this item is not necessary, the research team believes that CCA research usually faces more unexpected situations than development research, because people lived in different cultures usually have various value systems, goals, expectations, standards and concerns, which maybe result in more unexpected manifestations. So, more attentions on these temporary situations and explanations in the reporting are very necessary for researchers and examinee to understand the uniqueness of the target culture.
Section 5. Discussion -item 17: Synthesize all the evidence produced in the study and generate a comprehensive main result, regardless negative or positive, qualitative or quantitative, con rmatory or exploratory ndings and related clues. In addition, please interpret and evaluate the relationship between the actual evidences and expecting hypothesis. -item 20: The authorization from the copyright owner in CCA research is very important. It is equally important that translators should return related documents, results and interpretations of the translation to the copyright owner. If applicable, the assessment and advice from the copyright owner should be also provided. If the copyright is public or free, it is not subject to this restriction.
-item 21: The lack of using strategies usually confusing users once they need the instrument. Please provide the key information of instrument obtaining, paying, printing, administrating, scoring, analyzing and results interpreting.
-item 22: Basing on all the evidences generated in the study, please describe the main ndings and give a rational explanation and evaluation, as well as the inspirations of further research.
Section 6. Other information -item 23: If the detailed information was not allowed in the text, please provide them as much as possible in the appendix, includes but not limits to the nal target instrument, original instrument, research manual, authorizations, ethics permission, series of instruments generated in the CCA procedure, etc.
-item 24: List all the funding and provide their potential in uence on present and future studies, including the sponsor's participation degree and impact on the study design, implementation, analysis, and result interpretation.

Advantages and Limitations
The main advantage of this study are the comprehensive quantitative analysis with rigorous statistically criteria for the items and rounds analysis for the Delphi survey, which raised the credibility and uniformity. In the meantime, we performed saturated information extraction of expert's qualitative reviews to surmount the possible weaknesses for quantitative analysis.
The primary limitation of this study are that the " nal" version of IRICA statement is not really " nal" but a preliminary draft, because it lacks of face-to-face consensus discussion, pilot test, international feedback and criticism, etc., accorded to the guidance for developers of health research reporting guidelines [14].
The second limitation are the narrow geographic representation of the experts participated in the Delphi survey, though they have plentiful professional backgrounds and title grades. It may be results in the loss of many cutting-edge views, at least to some extent. Therefore, this statement maybe receives more accusations or oppositions. However, this exact is an important purpose of this paper, which is to seek more and wider professional opinions from global researchers. Any constructive comments, advice and criticisms are welcomed to the corresponding author. The optimization of this statement aims to improve its science and recognition is still continuing.

Conclusions
Based on comprehensive literature reviews and mixed analysis of international experts surveys, this study established a preliminary checklist to improve the reporting quality of instrument Cross-cultural Adaptation research (the IRICA statement), which contains 6 sections and 24 items, and explained its contents in detail. The IRICA statement is developed to help inform the reporting of instrument Cross-cultural Adaptation research. It can also be used in reporting quality evaluation and study design assistant to some extent. It is inevitable that some limitations deduced its recognition, more efforts to enhance its science is going on to improve the overall reporting quality of instruments Cross-cultural Adaptation research.

Consent for publication
All authors read and approved the nal manuscript.

Availability of supporting data
The data that support the ndings of this study are available on request from the corresponding author, HOU Zheng-kun.

Competing interests
Non-nancial associations that may be relevant or seen as relevant to the submitted manuscript. All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: no support from any organisation for the submitted work; no nancial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have in uenced the submitted work.