A Translation and Cross-Cultural Adaptation to a North American Context of the 51-Item Swedish Flodén Attitudes Toward Organ Donor Advocacy Instrument (Flodén ATODAI)

Background: Intensive and critical-care nurses are the key to successful donor management in the critical-care setting. No studies measuring attitudes toward organ donor advocacy existed before 2011, when the 51-item Swedish “Attitudes Toward Organ Donor Advocacy Scale” was developed. The aim of this study was to translate, adapt and establish the psychometric properties of the North American version of the Flodén ATODAI (Attitudes Toward Organ Donor Advocacy Instrument) in terms of validity and reliability. Methods: A multi-step approach was used: Initial translation; Back-translation; Review and synthesis of these translations; Expert panel (N=7) rated the prefinal version of the instrument for content validity index (CVI); International panel made adjustments guided by the expert panel . Reliability testing with test and retest of the adjusted 46-item version was conducted using intraclass correlation coefficient (ICC), weighted kappa ( ҡ Weight ), sign test, and Cronbach’s alpha coefficient (α), (N=50); and finally Delphi technique procedure with a preselected Delphi panel (N=15). Results: The CVI was determined to be greater than the 0.05 significance level. Item level (I-CVI) ranged 0.82-1.0, with a mean of 0.97. Scale level (S-CVI) on the entire instrument was 0.97. Test-retest procedure was performed to estimate stability. In total, 34 of the items had good-to-high ICC. Accepting an ICC of > 0.70 resulted in a total of 24 items. Homogeneity reliability was estimated by α and was calculated for these items where α=0.90. In total, 20 of the items had a substantial or almost perfect ҡ Weight and 23 showed a moderate ҡ Weight . None of the items showed systematical differences. The Delphi technique procedure was used on the 22 items with ICC <0.70 resulted in adjustments establishing that consensus was achieved. Conclusions: Undertaking this multi-step, cross-cultural adaptation procedure has effectively ensured that the 46-item Flodén ATODAI North America version produces valid and reliable measurements.

No studies measuring attitudes toward organ donor advocacy (ATODA) in a clinical context existed before 2011. One reason for this is the absence of validated measuring instruments. In 2011, with the intent to gain an understanding of nurses' behavior, and their level of ability to advocate for their patients who are either potential or actual organ donors, Flodén et al. (13) developed the 51-item Swedish instrument "Attitudes Toward Organ Donor Advocacy Scale" (ATODAS) to measure ATODA among ICU and CC nurses. This instrument measures ATODA by describing nurses' actions while caring for potential organ donors and throughout the donation procedure and evaluates changes in organizational structure, guidelines, and educational interventions. The ATODAS is validated in the Swedish context by its application on more than 1,200 ICU nurses, i.e. >50% of all ICU nurses in Sweden. This ATODAS instrument is limited to the Swedish context since it only exists in the Swedish language. Today the ATODAS is to our knowledge the only established instrument within the context of measuring organ donor advocacy, and there is a need for a universal translation among different cultures and countries. Currently, the Flodén ATODAI [North American version] is in use in several countries and continents, and the process of developing a Spanish version has started.
Since specific behavior by ICU personnel is significantly associated with the frequency of referral and OD consent, it is of crucial importance to understand the reasons behind ODA. The concept of ODA in the situation of OD is defined by Flodén et al. (5) as respecting the potential or actual organ donor's rights, representing, or speaking up for his/her wishes, as well as the family's points of view, in the OD decision-making process. According to the International Council of Nurses' Code of Ethics, a nurse's primary professional responsibility is to people requiring nursing care. Thus, nurses' behavior and their level of ability to advocate for their patients' desires applies to potential and actual organ donors (14). In regard to nurses' professional ethics in situations when the possibility of OD arises, nurses should represent and defend their patients' wishes regarding ODA (15). The relative rarity of 4 OD in any hospital or country makes it important to reach out to an international clinical context to establish developmental changes, i.e. professional and/or organizational. After reviewing the roles and practices of ICU and CC nurses in North America, it became clear that the Swedish ATODAS needed to be adjusted to be used in North America (16). Therefore, the aim of this study was to translate, adapt, and establish the psychometric properties of the Swedish ATODAS to one which would be equally valid and reliable in North America. As part of the instrument development in this study, the name of the instrument changed from ATODAS, the 51-item Swedish scale, to Flodén ATODAI (Attitudes Toward Organ Donor Advocacy Instrument), the North American English version.

Design
The study used a methodological design comprising of a cross-cultural adaptation procedure to effectively translate the 51-item Swedish ATODAS instrument for use in other cultural and language settings. Specifically, the study considered Brislin's multi-step approach as best practice (18). An additional Delphi technique procedure was performed on the Flodén ATODAI [North American version] as a complementary adaption approach to secure higher scientific certainty of the instrument with regard to validity and reliability by testing the items for content relevance, clarity, and domain coverage.

Description of the ATODAS [Swedish version]
Flodén et al. (13) developed the Swedish 51-item ATODAS as a means of psychometric evaluation of measuring ICU nurses' ATODA, including validation and reliability testing. In addition to the demographic data, the instrument contains three dimensions covering statements about attitudes toward: actions to safeguard the wishes of the potential organ donor; actions for supporting the family of the potential organ donor; and actions that promote OD at an organizational or structural level.

Translation and cross-cultural adaption of the Flodén ATODAI [North American version]
The procedure to transfer the Swedish ATODAS instrument into an international arena was guided by Brislin's (18) multi-step back-translation approach, complemented by a Delphi technique procedure 5 ( Figure 1).

The first step was for a professional and native American English-speaking interpreter and bilingual
Swedish translator to translate the Swedish ATODAS instrument into American-English. The second step comprised of back-translation into American-English, as performed by another expert-a native Swedish-speaking bilingual translator. The translation was performed blindly, i.e. without access to the original version of the Swedish ATODAS.
Step three constituted cross-language testing by the international committee, consisting of three OD specialists; one representing Sweden (PI), and two representing the United States of America

Study Populations: Steps Four to Six
Step four: Seven designated ICU or CC nurses in the greater Los Angeles with experiential knowledge of caring for at least one organ donor formed an expert panel. The panel evaluated the content validity of the items, with reference to Lynn's criteria (17). All seven nurses on the panel were female, aged between 29-55 years with a mean age of 44.2 years, and their work experience in the ICU and/or Emergency Department ranged between 5-31 years. The panel represented nurses from trauma, education, and teaching hospitals: Three worked in the ICU; three in the Emergency Department; and 6 one in the Education Department. Three of the experts were managers/charge nurses, one was a clinical nurse specialist, one a nurse educator, and two were bedside nurses.
Step five: In total, 50 ICU nurses from two hospitals-one university-affiliated hospital (with different types of ICUs) and one county or community hospital (one ICU) ( Table 1)-in the greater Los Angeles area participated in the test and retest. The inclusion criteria were: Being an ICU or CC nurse; experiential knowledge of caring for at least one organ donor; and currently working in a clinical setting with OD.
The exclusion criteria were: Being a nurse who was not currently working and/or being a nurse without experience of caring for organ donors.
Step six: A preselected panel of 15 nurses in the United States of America, with extensive experiential knowledge of caring for organ donors, comprised the Delphi panel for the purpose of completing the additional Delphi technique procedure ( Table 2).

Data Collections and Analysis: Steps Four to Six
Step four: First data collection The first data collection required testing the prefinal version of the Flodén ATODAI [North American version]. The expert panel was given a rating form with the theoretical definition and a delineation of the three dimensions, objectives, and items. They were asked to review the prefinal 51-item version of the Flodén ATODAI [North American version] for content relevance, clarity, and domain coverage and to rate each item on a 4-point scale (from 1=not relevant to 4=very relevant) (17,19).
Step four: First data analysis

Content Validity
The expert panel was formed to estimate the content validity (with reference to Lynn's criteria (17)) of the items. Content was considered valid when an item was rated as either 3 (relevant and needs little revision) or 4 (very relevant) by at least six evaluators (>86%) and, thus, was included in the new scale (17).
The international committee analyzed the content validity rating by the expert panel and weighted the scores, which resulted with the prefinal 51-item instrument being reduced to 46 items. Of the remaining 46 items, five items were re-worded, as guided by the recommendations of the expert panel. A content validity index (CVI) was calculated to indicate the extent of expert agreement, both for the item CVI (I-CVI) and for the scale CVI (S-CVI). An I-CVI was determined by the number of experts who rated an item content as valid (giving it a rating of 3 or 4) divided by the total number of experts, resulting in a proportion of agreement for each item. The S-CVI was determined by the averages of the I-CVIs (17,19).
Step five: Second data collection The study performed a test-retest procedure to estimate stability (reliability testing) of the adjusted version of the prefinal 46-item version of the Flodén ATODAI [North American version], as developed from the data analysis performed in step four. Fifty ICU nurses agreed to participate by answering the instrument on two occasions, with two weeks in between.
Step five: Second data analysis

Test-Retest Reliability
The intraclass correlation coefficient (ICC) was used to measure the strength of agreement between the test and retest, using ordered categorial data (20). The level of agreement was confirmed via the weighted form of kappa coefficients (ҡ Weight ) (21).
Moreover, the sign test tested for whether systematical differences occur in either direction, described by exact agreement. The test was two-sided and conducted at the 0.05 significance level.
The ICC, the ҡ Weight , and the sign test analyses were performed using SAS software version 9.4 (SAS Institute Inc., Cary, NC, USA).

Homogeneity and Stability Reliability
Homogeneity reliability was estimated using Cronbach's alpha coefficient (α) via SPSS 18.0. According to the conventional rule by Nunnally, this coefficient should at least exceed 0.70 (22).
Step six: Third data collection

Content Validity
The first data collection comprised of the expert panel rating the prefinal version of the Flodén ATODAI [North American version]. The international committee then analyzed this data for CVI by calculating both the I-CVI and the S-CVI. The I-CVI ranged from 0.82 to 1.0, with a mean of 0.97, while the S-CVI averaged 0.97. This meant the CVI was >0.78 and, therefore, content validity was established beyond the 0.05 significance level, which is the required criterion according to Lynn (17) and Polit and Beck (19). This resulted in a reduction of the number of instrument items from 51 to 46.
Of the remaining 46 items, five were re-worded using the recommendations of the expert panel.

Test-Retest Reliability
The strength of agreement between the test and retest was calculated both by ICC and by ҡ Weight .
Also, the sign test was used to identify whether any systematical differences had occurred. The 46item Flodén ATODAI [North American version] showed an ICC between 0.268 -0.911 (Table 3). In total, 34 of the items had a good or excellent ICC (Good n=18 (0.60-0.74); Excellent n=16 (>0.75)).
None of the items showed statistically significant systematic changes. The retest values were systematically higher for most of the items. The ICC values were, as is to be expected, very similar to those of ҡ Weight (25).

Homogeneity and Stability Reliability
Homogeneity reliability was estimated using α for the 24 items identified with an ICC >0.70 was α =0.90. None of the items had a greater α coefficient "if item was deleted", meaning that none of the items would substantially affect reliability if they were removed. Furthermore, all items had a "corrected item-total correlation" of 0. In a situation where the possibility of OD occurs in the ICU, the nurses are expected to enable the donation, within the boundaries of professional ethics (14,15). After review of the role and practice of the ICU and CC nurses in the United States of America, it became obvious the Swedish ATODAS needed adjustment before it could be used in North America, to fit its socio-cultural and legal context.

Conclusion
The translated and tested instrument Flodén ATODAI [North American version] was adapted to be culturally relevant, yielding valid and reliable results for use in a clinical North American context 13 within a global perspective. Undertaking this multi-step approach has effectively ensured that the cross-cultural adaptation procedure resulted in a stronger instrument for valid and reliable measurements. The North American version of the Flodén ATODAI provides a framework for researchers in general, but clinicians in particular, choosing to utilize this instrument for work in other cultural and geographic settings. Study limitations are that content validity of the 46-item Flodén ATODAI needs to be further scrutinized. Therefore, the next step should be to use the instrument in a large-scale study within North America and implement factor analysis to determine construct validity.   (20) 19 Excellent correlation (0.75-1.00) n=16