Ethical considerations
The research protocol was approved by the Institutional Review Board of The Affiliated Brain Hospital of Nanjing Medical University (Approval No. 2021KY02801). Prior to the investigation, all participants meeting the inclusion criteria signed the informed consents and were informed of the objectives of the study, confidentiality of personal information and the right to withdraw from the study by investigators.
Participants
Thirty participants were selected for the pre-test [28], they were recruited from psychiatric department and medical psychological department of one tertiary psychiatric hospital in China in July 2020.
Inclusion criteria were as follow: (a) age 18-60 years old; (b) with a diagnosis of depression as confirmed by a medical professional according to the International Classification of Diseases, 10th Edition (ICD-10); (c) volunteered to participant in this study and signed an informed consent.
Exclusion criteria were as follow: (a) with somatic diseases; (b) with cognitive impairment and communication disability.
Data collection
The data collection was completed by three investigators (all were research members in this study) through convenient sampling. To ensure the consistency of data collection, three investigators took part in training sessions in which they were trained to use identical introduction, evaluation criteria and were asked to complete the Chinese version of OMMP scale for the same subject to check for the discrepancy. Eligible participants in the study signed the informed consents and were introduced the purpose of the study and requirements for filling in OMMP scale. During the investigation, investigators read out all items and filled in the questionnaires if the participants were illiterate or had blurred vision. After the completion of the scale, participants were interviewed face-to-face with regard to the OMMP scale.
Design
The research group consisted of six members, including one psychiatric nurse-in-charge and one psychiatric chief physician, one professor of nursing, three graduate students of psychiatric nursing. Before the research, the project manager introduced the significance, procedure, clinical value of the present study, all members in the team were mainly responsible for literature review, translation, drafts revision and expert selection. This study was divided into two sections: Phase 1: forward-translation, back-translation and cross-cultural adaptation were conducted to finalize the Chinese version of OMMP scale, we applied the multi-step forward-backward translation techniques of Brislin translational model and a two-round modified Delphi process in the current study. Phase 2: the prefinal Chinese OMMP scale was pretested in a sample of thirty depressed patients via a cross-sectional survey. The implementation process is presented in Fig.1.
Step 1: Forward-translation
Two native Chinese translators (T1, T2) were invited to participant in the forward-translation to independently translate the English version of the original scale into Chinese version. One of the translators (T1) had more than five years of working experience in psychiatric department with the certificate of Test for English Majors-Band 8 (TEM-8), the other was a college teacher with a postmaster degree in linguistics (T2). Then the two Chinese drafts (V1, V2) were integrated into one draft (V3) by research manager after discussion with group members.
Step 2: Back-translation
The Chinese version was separately translated back into English (V4, V5) by two bilingual translators who previously had no access to the original scale and were knowledge of Chinese and English-speaking culture. One of them was a graduate student of nursing with overseas education background (BT1), the other one was an associate professor of nursing with British visiting experience (BT2). Two back-translated versions were synthesized into one draft (V6) by research manager after coordination with group members. Subsequently, the integrated draft (V6) and the original scale were examined and compared by an expert who is familiar with the Chinese and English expressions and language cultures. This expert proposed several amendments that was serve as guide for researchers to ensure equivalence and consistency in terms of wording, concept and semanteme. Finally, the first Chinese version of OMMP scale formed.
Step 3: Cultural adaptation (a two-round Delphi survey and pilot testing)
An e-Delphi technique was employed in the cross-cultural adaptation via publicly available emails, online questionnaires were administered to seven experts in the field of psychiatry, psychiatric nursing and psychology. The questionnaire consisted of three parts: 1) The basic information questionnaire of experts; 2) The Chinese and English statement lists; 3) The expert’s authority questionnaire. For the content validity index (CVI), experts were asked to evaluate each item for relevance, the relevance used a 4-point Likert scale in which 1-completely irrelevant, 2-irrelevant, 3-relevant, 4-completely relevant. For the concordance among experts, the importance of each item was rated by experts which was scored on 5-point Likert-type scale (5-very important, 4-important, 3-average, 2-unimportant, 1-very unimportant). Additionally, experts were advised to put forward comments on semantic, idiomatic and conceptual aspects and to complete questionnaires in two weeks. The feedback was organized into a summary by two research members and presented to the research team. After the first round of the Delphi study, the response and outcome were refined from the collected data. Statements that didn’t achieve agreement in R1 were sent back to the same expert group for review in the second of Delphi study after revision. R2 was again done in the form of online questionnaire. Similar to R1, the data obtained from R2 was analyzed by research members. The time interval between two rounds of survey was two weeks, in order to avoid interaction effect between the results of two rounds of Delphi survey[29].
The pretest was conducted on thirty hospitalized patients from psychiatric department and medical psychology department. During the investigation, the items were read or further explained by investigators if the patients were illiterate or had blurred vision, and the complete time was also calculated. When finished the questionnaires, participants were inquired about the understandability and clarity of the pre-final Chinese version of OMMP scale and were asked to provide some suggestions via face-to-face interviews, the feedback was recorded by investigators and used for modification by group members. After the above steps, the final Chinese version of OMMP scale was determined.
Statistical analysis
Data were analyzed using the Statistical Package for the Social Sciences (SPSS), Version 25.0. Descriptive data were expressed in coefficient of variation (CV), active coefficient and authority coefficient (Cr) of experts as well as consistency of expert (W). The value of CVI (I-CVI, S-CVI/Ave) estimating the content validity and the value of Kendall’s W were calculated by Excel software.