Development and psychometric evaluation of the family intensive care units syndrome inventory

Abstract Background Family members of patient in the intensive care unit (ICU) experience a set of problems which are entitled Family Intensive Care Units Syndrome (FICUS). Objectives The aim of this study was to develop and psychometrically evaluate the FICUS Inventory (FICUSI) in Iran. Methods This sequential exploratory mixed method study was conducted in 2020 in two main phases. In the first phase, FICUSI was developed based on the results of an integrative review and a qualitative study. In the second phase, the psychometric properties of FICUSI, namely, face, content, and construct validity, reliability, responsiveness, interpretability, and scoring, were evaluated. The sample for the construct validity evaluation consisted of 283 ICU family members. Results The primary item pool of FICUSI had 144 items and was reduced to 65 items or omitting overlapping and similar items. The scale‐level content validity index of FICUSI was 0.89. In the construct validity evaluation through exploratory factor analysis, 31 items with factor loading values more than 0.3 were loaded on two factors (namely psychological symptoms and nonpsychological symptoms) which explained 68.45% of the total variance. The Cronbach's alpha and the test‐retest intraclass correlation coefficient of FICUSI were 0.95 and 0.97, respectively. Conclusion FICUSI is a valid and reliable instrument which can be used in clinical settings and studies for FICUS assessment. Further studies for the cross‐cultural adaptation of FICUSI in other contexts are recommended. Relevance to clinical practice Health care providers in clinical settings can use FICUSI to assess FICUS among the family caregivers of patients in ICU. Health care providers’ better understanding of FICUS helps them understand the quality of their own services for the family members of patients in ICU.


INTRODUCTION
Many patients are hospitalized each year in the intensive care unit (ICU). The ICU admission rate has increased in recent years due to the increasing prevalence of age-related problems and chronic conditions (Hawari et al., 2016;Jolivot et al., 2016).
The ICU setting is a complex and stressful environment for the patients and their family members (Beesley et al., 2018). The major sources of stress for the family members of patients in ICU are sudden and unexpected hospitalization of a patient in ICU, unfamiliarity with medical procedures and equipment, implementation of invasive procedures, prolonged ICU stay, and risk of death (McAdam et al., 2010;Schmidt & Azoulay, 2012). The effects of ICU hospitalization on family members are so intense that they may even ignore their own basic needs such as rest, food, and thereby, lose their ability to effectively the problems and strains (Maghsoudi et al., 2007). Ineffective coping with problems can lead to different psychological problems, such as stress, anxiety, despair, depression, and posttraumatic stress disorder for ICU family members (Davidson et al., 2012;Loiselle et al., 2012;Sarhadi et al., 2016). Previous studies reported the high prevalence of health-related problems, such as anxiety (37%-79%), depression (27%-70.3%), lack of energy, fatigue, grief (52%), and altered quality of life among the family members of patients in ICU Kang et al., 2021;Kentish-Barnes et al., 2015;McAdam et al., 2010). These problems may start with ICU admission and last for days to months after ICU discharge (Choi et al., 2012;McAdam et al., 2010).
In recent years, the term Family Intensive Care Units Syndrome (FICUS) has been used to refer to the problems of the family members of patients in ICU. This syndrome is a set of psychological problems which occur for family members during patient hospitalization in ICU (Davidson et al., 2012;Schmidt & Azoulay, 2012). Recent studies highlighted that FICUS includes not only psychological problems but also physical, spiritual, and social problems (Saeid et al., 2020(Saeid et al., , 2021. Therefore, FICUS can be a threat to the physical, psychological, spiritual, and social health of the family members of patients in ICU (Saeid et al., 2021).
A key step in FICUS management is its accurate assessment Questionnaire (Barth et al., 2016;Bolosi et al., 2018;Davidson et al., 2012). These instruments are not FICUS-specific and mostly assess psychological problems such as anxiety and depression. The only FICUS-specific instrument is the Iowa ICU Family Scale which focuses on behavioral responses and does not cover other aspects of FICUS (Halm et al., 1993). Lack of a comprehensive and specific instrument is a major barrier to effective FICUS assessment (Major et al., 2016) and highlights the need for further studies to develop such instruments. The present study tries to narrow this gap. This study was conducted to develop and psychometrically evaluate the FICUS Inventory (FICUSI).

Design and setting
This sequential exploratory mixed method study was conducted in 2020 in Iran. The study was conducted in two main phases, namely, of FICUSI development and FICUSI psychometric evaluation ( Figure 1).

Phase 2. The FICUSI psychometric evaluation
In this phase, the psychometric properties of the FICUSI were assessed.
These properties were face, content, and construct validity, reliability, responsiveness, interpretability, and scoring.

Evaluation of face validity
Face validity was evaluated through quantitative and qualitative methods. In the qualitative appraisal of face validity, face-to-face cognitive interviews were held with 12 family members of patients in ICU, participants were asked to comment on the difficulty, appropriateness, and clarity of the items and then, necessary revisions were made based on their comments. In the quantitative evaluation of face validity, item impact score was calculated for all items. Accordingly, 12 ICU family members were invited to rate item suitability on a five-point scale as follows: (5) "Completely suitable"; (4) "Suitable"; (3) "Relatively suitable"; (2) "Slightly suitable"; and (1) "Not suitable at all." Finally, item impact scores were calculated by multiplying frequency by suitability and items with impact scores higher than 1.5 were considered suitable (Johnson, 2021;Taghizadeh et al., 2017 In the quantitative content validity evaluation, content validity ratio (CVR) and index (CVI) and modified kappa were calculated. Accordingly, the experts were asked to rate item essentiality on a three-point scale ("Essential," "Useful but not essential," and "Not essential"), and their rating scores were used to calculate CVR. CVI was also determined through asking the experts to rate item relevance on the following four-point scale: (1) "Irrelevant"; (2) "Somewhat relevant"; (3) "Relevant"; and (4) "Completely relevant." Then, the CVI of each item was calculated through dividing the number of experts who had rated that item 3 or 4 by the total number of the experts. Items with CVR, CVI, and modified kappa values more than 0.49, 0.78, and 0.74, respectively, were considered acceptable Polit et al., 2007).

Item analysis
In this step, 48 ICU family members completed the FICUSI and Cronbach's alpha was calculated. Items with inter-item correlation coefficients more than 0.7 and corrected item-total correlation coefficients less than 0.3 were considered acceptable

Evaluation of reliability
Reliability was evaluated by evaluating internal consistency, test-retest stability, and standard error of measurement (SEM). Cronbach's alpha was calculated by internal consistency evaluation and values more than 0.7 were considered acceptable (Taber, 2018

Responsiveness
The responsiveness of the FICUSI was evaluated by calculating SEM and minimal detectable changes (MDC) as follows: SEM = SD√1 and MDC = SEM × z × 2.

Interpretability
The interpretability of the FICUSI was evaluated using minimally important changes (MIC), ceiling and floor effects, distribution of the total score, and percentage of missing items.
MIC calculation: MIC was calculated by multiplying the standard deviation of test-retest changes by a moderate effect size of 0.5 (Wright et al., 2012). A MIC value greater than MDC confirms interpretability .
Ceiling and floor effects: Ceiling and floor effects were calculated for the FICUSI and its factors. Ceiling and floor effects exist when more than 20% of respondents obtain, respectively, the highest and the lowest possible scores of the intended instrument (Ho & Yu, 2015). For calculating the ceiling and floor effects of the FICUSI, the percentage of participants who had obtained, respectively, the highest and the lowest scores was calculated.
Evaluation of the distribution of the FICUSI score: The total score of each instrument is expected to vary in different groups such as gender or age groups. In this study, the distribution of FICUSI score was assessed through comparing FICUSI mean score in gender groups.
Evaluation of the missing items: The frequency of the missing items was calculated through dividing the number of unresponded items by the total number of the items and multiplying the result by 100 (Dong & Peng, 2013). Missing data were replaced with the mean score.

FICUSI scoring
The FICUSI items were scored on a Likert scale as follows: (1) "Never"; (2) "Rarely"; (3) "Sometimes"; (4) "Usually"; and (5) "Always." The linear transformation method was used to transform the scores of the FICUSI and its factors to an identical scale in order to facilitate understanding and comparison of the scores. The inventory scores range from 0 to 100. Therefore, higher the FICUSI scores show more severe FICUS.

Ethical considerations
This study was approved by the Ethics Committee of Baqiy-

Statistical analysis
The SPSS software (v. 24.0) was used to analyze the data. The data were presented through the measures of descriptive statistics (namely frequency, mean, and standard deviation). Data analysis was performed through the Kolmogorov-Smirnov and the independent-sample t tests, exploratory factor analysis, ICC, and Cronbach's alpha.

Phase 1. FICUSI development
The results of the literature review revealed the lack of a clear definition for FICUS and the limitation of FICUS to psychological symptoms (Saeid et al., 2020). However, the results of our qualitative study showed that the experiences of the family members of patients in ICU can be categorized into four main categories, namely, of threat to psychological well-being, threat to physical health, threat to social health, and change in spiritual orientation. Therefore, hospitalization in ICU can cause family members not only psychological problems but also physical health problems, alterations in healthy interpersonal relationships, and changes in spiritual beliefs (Saeid et al., 2021

Item analysis
All inter-item correlation coefficients were less than 0.7, whereas five items were omitted due to item-total correlation coefficients less than 0.3. Therefore, the number of items reduced to 35.

Item
Item generation in the first phase (144 items) Duplicated items were omitted (54 items).
Items with corrected item-total correlation coefficients < 0.3 were omitted (5 items).
Items with low factor loading values were omitted (4 items).

Evaluation of responsiveness
The MDC of FICUSI was 9.33%. An MDC of less than 30% is acceptable, and an MDC of less than 10% is excellent.

Evaluation of interpretability
Based on test-retest standard deviation, MDC was calculated to be 9.33%. Ceiling and floor effects were 0.7% and 0.4%, respectively, for the FICUSI, 1.8% and 0.4% for its psychological symptom subscale, and 0.7% and 1.4% for its nonpsychological symptom subscale.
Respecting the distribution of the FICUSI score, the mean score of the FICUSI in the 0-100 range was 55.41 among male participants and 53.49 among female participants. Regarding the missing items, findings showed that participants had answered more than 99.9% of the items.

TA B L E 2
The results of exploratory factor analysis to determine the factor structure of Family Intensive Care Units Syndrome Inventory (FICUSI)

Scoring
The 17-item psychological symptom subscale of the FICUSI has a total score of 17-85, and the 14-item nonpsychological symptom subscale has a total score of 14-70. Naturally, after converting the scores to the standard score, the closer an individual's mean score was to 100, the higher scores of the FICUSI show more severe FICUS.

DISCUSSION
The present study aimed at developing and psychometrically evaluating the FICUSI. Findings showed that the final FICUSI has 31 items in two main subscales, namely, psychological symptoms and nonpsychological symptoms.
The psychological symptoms subscale of FICUSI has seventeen items on the psychological problems associated with patient hospitalization in ICU. The basis of this subscale was the psychological symptoms main category and its emotional distress, hopelessness, changes in sleep pattern, and mood changes subcategories in our qualitative study (Saeid et al., 2021). This subscale addresses psychological symptoms which family members experience following their patients' hospitalization in ICU. Psychological problems among the ICU family members are more severe and more prevalent than nonpsychological problems. Studies reported anxiety, stress, depression, and sleep disorders as the most prevalent psychological problems among these family members (Choi et al., 2016;Day et al., 2013;McAdam & Puntillo, 2009 to these problems, though some studies reported that these family members experience physical problems, such as fatigue and sleep disorders (Choi et al., 2014;Choi et al., 2013;Day et al., 2013) (Ho, 2013). The Cronbach's alpha values of the FICUSI and its two subscales as well as the test-retest ICC of the instrument were also greater than 0.90, confirming its high reliability. Other psychometric properties of the FICUSI (including responsiveness and interpretability) were also acceptable.

Limitations
One of the limitations of the present study was our limited access to eligible ICU family members which prolonged the process of sampling. Moreover, the FICUSI was developed and psychometrically evaluated in the sociocultural context of Iran and hence, cross-cultural adaptation of the inventory in other contexts is necessary.
The other of limitation was failure to performed confirmatory factor analysis because coronaviruses disease (COVID-19) pandemic and the impossibility of access to family members.

Implications for critical care nursing practice and research
Critical care nurses in clinical settings can use the FICUSI to assess FICUS among the ICU family members. Increasing critical care nurses' awareness and understanding of FICUS helps them understand the quality of their own services for the ICU family members.
Based on the results of the FICUSI, health care providers can develop appropriate strategies to improve the experiences of these family members. Moreover, researchers can use the FICUSI to assess FICUS and monitor the effects of the available guidelines and their interventions on FICUS. Furthermore, the FICUSI can be used to assess the educational needs of nurses and other health care staff in ICU to develop and provide FICUS-related training.

CONCLUSION
The FICUSI is a valid and reliable FICUS-specific instrument for comprehensive assessment of psychological and nonpsychological aspects in Iran. This instrument can also be used to assess FICUS changes over time.

What is known about the Topic?
■ FICUS is a major threat to health among the family members of patients in ICU.
■ A key step in FICUS management is its accurate assessment using valid and reliable instruments.
■ Lack of a comprehensive and specific instrument for FICUS assessment is a major barrier to effective FICUS assessment and management.

What this paper adds?
■ Psychometric evaluations showed that the FICUSI has acceptable validity and reliability.
■ The nurses and researchers can use the FICUSI to assess FICUS and monitor the effects of the available guidelines and their interventions on FICUS.
■ Based on the results of the FICUSI, health care providers can develop appropriate strategies to improve the experiences of these family members.
■ The results of the FICUSI application can be used to develop more effective programs and interventions for FICUS management.