3.1. Study Design
This study was conducted in two phases, one of which included item generation and tool design and the other one involved item reduction and psychometric evaluation.
3.1.1. The First Phase: Item Generation
This qualitative study was performed through in-depth, individual interviewing with 21 individuals, including 14 patients and seven therapists, using conventional content analysis. The research environment was the open-heart surgery wards of two government hospitals in Ahvaz, southern Iran. The study was performed from May 2016 to March 2017. The inclusion criteria were: (1) the first experience of undergoing open-heart surgery, (2) a minimum age of 18 years, (3) consciousness, and (4) willingness to retell experiences. On the other hand, the exclusion criterion was withdrawal from study participation. Sampling was performed using the purposive sampling technique and continued until data saturation (14). The duration of the interview varied between 20 and 90 min.
Data analysis was carried out following Graneheim and Lundman (15). The tool items were extracted from the findings of a qualitative study (an inductive approach) and review of the literature (e.g., ICUESS and RCSSS; a deductive approach). Subsequently, the initial design of the instrument was performed, and a pool of items was formed. Ultimately, the research team refined the tool to prepare it for the next stage (i.e., psychometric evaluation).
3.1.2. The Second Phase: Item Reduction and Psychometric Evaluation
3.1.2.1. Face Validity
The face validity of the tool was evaluated both quantitatively and qualitatively. The assessment of the qualitative face validity was accomplished through face-to-face interviews with 10 open-heart surgery patients. In the interviews, the patients were asked to read the items loudly, explain the meaning of each item, and specify the inappropriate or vague phrases for correction (16). Accordingly, some of the items were modified and revised based on the patient’s view.
The quantitative face validity was performed to determine the importance of each item. To this end, the instrument was provided to another group of open-heart surgery patients (n = 10), and they were asked to give a score of 1 - 5 to each item in terms of their importance. Subsequently, the item impact was calculated by multiplying the frequency (i.e., the percentage of the people giving the scores of 4 and 5 to the item) by the mean importance score of each item. The item impact of ≥ 1.5 was indicative of the appropriateness of the item (17).
3.1.2.2. Content Validity
The qualitative and quantitative content validities of the inventory were investigated using a panel of 10 experts, including two cardiac surgery clinical nurses, one anesthesiologist, one heart surgeon, five faculty members of psychology and nursing, and one tool development specialist. To this aim, the experts were asked to rate the content validity of each item using a three-point scale entailing “The phrase is necessary”, “The phrase is useful, but not necessary”, and “The phrase is not necessary”. Based on the Lawshe table, when the number of experts is 10, the minimum acceptable level for content validity ratio is 0.62 (18).
To assess the content validity index (CVI), the panel of experts was asked to rate each item on a four-point Likert scale (i.e., irrelevant, partly relevant, relevant, and completely relevant). Then, the number of experts who selected the last two answers was divided by the total number of experts (19, 20). Subsequently, the modified Cohen’s kappa coefficient was calculated. The modified Kappa coefficient of > 0.74 was considered the minimum value for keeping an item (21).
In addition, the scale-level CVI was calculated by averaging the item-level CVIs; in this regard, a value of 0.9 was considered acceptable (22). Finally, a pilot study was conducted on patients with open-heart surgery (n = 50) for item analysis. At this phase, the Cronbach’s alpha coefficient and loop method were estimated by investigating the inter-item and item-total correlations.
3.1.2.3. Construct Validity
In this study, the construct validity was evaluated using exploratory factor analysis and Multitrait-Monomethod approach (19). Sampling was performed through the convenience sampling technique. The minimum sample size for each item was between 5 and 10 people; therefore, a total number of 360 cases were enrolled in the study. The study population was selected from two public hospitals affiliated to the Universities of Medical Sciences of Tehran and Ahwaz, Iran. Finally, 360 inventories were completed and analyzed from August 2017 to February 2018. After data collection, the data were checked in terms of the fulfillment of factor analysis assumptions. To this end, the Kaiser-Meyer-Olkin (KMO) test was performed to determine the adequacy of the sample size. In addition, Bartlett’s test was run to check the correlation matrix.
The KMO values of 0.7 - 0.8 signify that sampling is moderately adequate, while a value of ≥ 0.9 is indicative of excellent sampling adequacy (20). The extraction of latent factors was accomplished using principal axis factoring and Varimax rotation. For the determination of the convergent validity through Multitrait-Monomethod approach, the correlation of the scores of the five factors (i.e., subscales) with the total score of the questionnaire was measured.
Furthermore, the assessment of the divergent validity was performed by the calculation of the correlation between the five factors of the inventory. Since the five factors are supposedly distinct structures, they should not have a high correlation; accordingly, a correlation of less than 0.7 is considered appropriate (23). Confirmatory factor analysis was also performed to confirm the factorial structure, determine the item-factor relationship, and evaluate the goodness of fit (24).
3.1.2.4. Reliability
The reliability of the inventory was determined using internal consistency and stability. To examine internal consistency, the Cronbach’s alpha coefficient was employed. A Cronbach’s alpha coefficient of > 0.7 was considered as indicating a satisfactory internal consistency. Stability testing was carried out through the test-retest method. To this end, the inventory was completed twice by 50 patients with an interval of two weeks. Then, the scores of the two stages were compared using the intra-lass correlation coefficient (ICC) test. An ICC of ≥ 0.8 represents a satisfactory level of stability (25).
3.1.2.5. Assessment of Floor and Ceiling Effects
The floor and ceiling effects were also calculated in this study. These effects are assumed to exist when more than 15% of the respondents obtained the highest or lowest achievable score (18).
3.1.3. Statistical Analysis
The Kolmogorov-Smirnov test was used to evaluate the normality of the data. Data analysis was performed in AMOS and IBM SPSS Statistics for Windows, version 24.0 (IBM Corp., Armork, N.Y., USA) using descriptive statistics, exploratory factor analysis, variance analysis, independent t-test, internal consistency coefficient, Cronbach’s alpha coefficient, Friedman test, and confirmatory factor analysis.
3.2. Ethical Considerations
The study was approved by the Ethics Committee of Jundishapur University of Medical Sciences in Ahvaz, Iran (IR.AJUMS.REC.2016.386). Research approval was obtained from the university and hospitals under investigation prior to data collection. Participation in the study was based on the principle of independence and willingness to partake in the interview. Furthermore, informed consent was obtained from all participants. Additionally, the participants were ensured about the anonymity and confidentiality of their information.
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