✅ The strong psychometric properties of the FIS-P indicated its applicability in assessing the impact of fatigue on stroke victim’s daily activities and the effectiveness of therapeutic and rehabilitation interventions.
Strokes are among the most common neurological diseases (1). Based on the lesion location, stroke survivors can suffer from various physical and cognitive impairments and emotional disturbances that can limit their functional abilities (2, 3). Post-stroke fatigue (PSF) is recognized as a common symptom, affecting 23-75% of stroke survivors (4). PSF is a debilitating condition that can cause lowered self-esteem, sleep disorders, anxiety, cognitive disorders, and mood disturbances, which adversely affects the victim’s quality of life, social participation, return to work, and mortality (4-6). Hence, early PSF diagnosis and interventions could increase stroke survivors’ quality of life and improve their physical and cognitive abilities (7). Although various tools for assessing fatigue are available, PSF lacks an approved gold-standard outcome (8). Therefore, the assessment of fatigue is challenging in two regards. The first challenge is related to the lack of a standardized scale for research purposes, and the second has to do with the intervention aims of the rehabilitation team and the absence of a tool for evaluating the impact of fatigue on stroke survivors’ daily lives (9).
There are a lot of fatigue assessment tools available, such as the fatigue severity scale (FSS) (10), fatigue impact scale (FIS) (11), fatigue assessment scale (FAS) (12), and fatigue scale for motor and cognitive functions (FSMC) (13). Most of them were originally designed to assess fatigue related to multiple sclerosis (MS). However, some of them are commonly used (with accurate results) for other groups of patients in other research fields, such in clinical settings (14, 15).
The FIS is a commonly used self-report scale that was developed by Fisk et al. in 1994 to evaluate the impact of fatigue on the everyday activities of MS patients (11,16). The FIS has been translated and validated in 30 languages and has been applied to evaluate fatigue among patients suffering from strokes, brain concussions, poliomyelitis, chronic fatigue syndrome, lupus, and hepatitis (17). The FIS is highly suitable for people who tend to control their fatigue and who try to identify the dimensions of their lives that are affected by fatigue (18). The scale contains 40 items that assess the fatigue-related limitations in the patients’ performance in cognitive (10 questions), physical (10 questions), and social (20 questions) activity domains. Studies have been carried out in different languages, such as American English (19), Hungarian (20), Turkish (21), and French (22). The FIS has also been translated into Persian and validated for MS patients (23).
The purpose of the present study is to determine whether the Persian version of the FIS (FIS-P) can be applied as a valid scale for measuring the effects of therapeutic interventions on fatigue control among stroke survivors. In this study, we aimed to assess the face, content, discriminant, and convergent validity, as well as the ceiling and flooring effects and reliability (test-retest, inter-rater, and internal sensitivity) of the FIS-P when administered to Persian-speaking stroke patients in Iran.
Design
In this cross-sectional methodological research carried out Mar-Sep 2015 and the psychometric features of the FIS (FIS-P) were investigated, with Persian-speaking stroke patients in Iran comprising the study population. The ethical protocol of this study followed the Declaration of Helsinki. The process was approved by the institutional review board of Iran University of Medical Sciences. All participants signed a written informed consent prior to enrollment.
Participants
The participants included 140 stroke patients who were referred to Tehran Occupational Therapy Clinics from 2015-2016, as well as 140 healthy adults who were matched with the stroke patients for age, sex, and marital status using the convenience sampling method. To be included in the study, stroke victims must have had their diagnosis confirmed by an expert neurologist and MRI report, must have had their first stroke during the study period, six months to five years must have elapsed since their stroke, and they needed to have an FSS score of greater than 4 (6).
Inclusion criteria for all participants were an age range of 45-70 years, the ability to read and write, adequate cooperation, an MMSE score of greater than 21, and Persian had to be their native language.
Exclusion criteria were a history of substance abuse; comorbidity with psychiatric, orthopedic, and neurological disorders (any lesions and anomalies in the central nervous system), sleep deprivation, chronic fatigue syndrome and other similar diseases. All participants denied using anti-fatigue medication. Data provided on incomplete questionnaires and scales were excluded.
Content validity was assessed by 20 occupational experts, each of whom had more than seven years of experience in stroke rehabilitation and at least five papers published in this field.
Setting
For all stages of this study, the assessment sessions for both groups were implemented in a quiet room in occupational therapy clinics between 8:00 a.m. and 1:00 p.m. The purpose of the research was clarified at the beginning of the session.
Procedures
Translation
The FIS was translated into Persian (24) and its psychometric version was examined in patients with multiple sclerosis (23). In this study, we used the FIS-P and examined the psychometric features in the stroke population.
Face validity
In order to determine the face validity of the scale, 20 patients with stroke stated the relevancy, suitability, clarity, and simplicity of each item of FIS-P Scale (24). In the end, an occupational therapist asked them to explain their perceptions of each item. Our approach for face validity was interpretability of the items (25).
Content validity
To control the content validity of the scale, 20 expert occupational therapists identified the essentiality and relevancy of each item of FIS-P (26).
Convergent validity
140 patients with stroke took part to determine the convergent validity of the FIS-P scale and fulfilled the FIS-P, FSS and SF, 36 in random order.
Discriminant validity
In order to define the discriminant validity of FIS-P between the normal population and stroke, 140 healthy adults and 140 patients with stroke were assessed using FIS-P.
Interrater Reliability
During two sessions in one day, two assessors, blinded to the aim of the study, asked 20 patients with dominant hemiplegia due to stroke to complete the FIS-P. The assessors read the items, explained the items if the participants needed clarification and filled in the blanks.
Test-retest reliability: A total of 40 patients with stroke fulfilled the FIS-P two times with a one-week interval.
Measures
We used the Persian version of the scales/ questionnaire in this study, and the process of the translation was based on International Quality of Life Assessment (IQOLA).
Fatigue Impact Scale (FIS)
The FIS-P was translated by Heidari et al. (24); permission from Mapi Research Trust was granted by MAPI (http://www.mapi-trust.org.). This scale includes 40 items on three subscales. The cognitive impact of fatigue subscale contains 10 items and focuses on the concentration, memory, thinking, and organization of thoughts. The physical impact of fatigue subsection includes 10 items and reflects motivations, endeavors, tolerance, and coordination. The social impact of fatigue subscale includes 20 items and describes the effects of fatigue on isolation, emotion, stress, and communication. Possible scores ranged from 0 (no problem) to 4 (extreme problem). For the entire scale, possible scores ranged from 0-160 points, with higher scores indicating more problems. The intra-class correlation (ICC) values for inter-rater reliability on the physical subscale, cognitive subscale, social subscale, and total score were 0.89, 0.86, 0.95, and 0.98, respectively; the test-retest reliability values were 0.86, 0.78, 0.92, and 0.93, respectively. The Cronbach’s alpha of the FIS-P was 0.95, which indicates the high reliability of the FIS-P (23). The questionnaire takes 10-20 minutes to complete and five minutes to score.
Fatigue Severity Scale (FSS)
This self-reported scale is comprised of nine items. The participants were to state their feelings over the past two weeks for each item, and scores could range from 1-7 points. High disagreement with an item yields a low score, while a strong agreement with an item yields a high score. The internal consistency of the items on the Persian version of the FSS was 0.96 based on Cronbach’s alpha coefficient. The correlation of each item with another item was 0.4. The ICC coefficient was 0.93 (27).
Short-form health survey (SF-36)
The SF-36 questionnaire consists of two main subgroups of items (physical and mental health), with each of these subgroups including four domains. The physical subgroup includes the domains of physical function (10 items), role limitation (four items), body pain (seven items), and general health (four items). The mental health subgroup includes the domains of social function (two items), role emotion (three items), vitality (four items), and mental health (five items). Scores on the SF-36 scale can vary between 0 and 100, with higher scores representing a higher level of health-related to one’s quality of life (28). The Persian version of the SF-36 was used in the present study. The internal consistency analysis of the Persian version of the SF-36 ranged from 0.77-0.90 (except for in the vitality domain). The correlation coefficient is greater than the recommended value of 0.4 (the coefficients ranged from 58.8-0.95). This survey is currently the most widely used instrument for measuring the quality of life in the world (29).
Statistical Analysis
The statistical analysis was accomplished using SPSS 16 (IBM Inc., Chicago, IL., USA). Content validity rate (CVR) and content validity index (CVI) were used as measures of content validity (26). The results of the Kolmogorov-Smirnov test determined the normal distribution of the FIS-P, FSS, and SF-36. Therefore, the Pearson correlation and independent-samples T-test were applied to examine convergent and discriminant validity, respectively. Cronbach’s alpha coefficients were used to assess internal consistency, and ICC was applied to determine inter-rater and test-retest reliability. Based on ICC correlation coefficients, reliability was interpreted as follows: <0.4 = weak, 0.4-0.7 = fine, >0.7 = great (30). Cronbach’s alpha scores were defined as follows: for >0.9 = excellent, 0.7-0.9 = good, 0.6-0.7 = acceptable, 0.5-0.6 = weak, and <0.5 = non-acceptable. (30). Furthermore, the standard error of measurement (SEM) was calculated to estimate measurement precision. SEM and MDC were calculated using the following equations: and (31, 32). A P-value of less than 0.05 was considered significant.
Table1 shows the result of the demographic variables. According to the results, 63.3% of study participants were male, and 36.7% were female. The time of hospitalization was below one week of age.
Table 2 illustrates the hearing loss status of the participants. In this study, 3.3% of study participants had moderately-severe hearing loss.
Table 3 shows the results of the study participants' associations with hearing disorder (ABR test). A significant statistical relationship was found between age variables at infant hospitalization, oxygen demand, bilateral hearing loss, and OAE fail, with hearing disorder (ABR test).
Furthermore, between aminoglycoside intake, age, positive familial hearing loss, number of days of hospitalization, type of illness with hearing disorders ( ABR test) were not significantly related. It showed that none of the participants in the study consumed furosemide. Also, none of the participants in the audiometric study had neuropathy.
Table 1. Results of Demographic Variables
P | Hearing Loss | Normal Hearing | Demographic Variables | |
0.65 | 2(1.3) | 53(35.3) | Female | Sex |
5(3.3) | 90(60) | Male | ||
0.42 | 6(4) | 103(68.7) | Term | Gestational age |
1(0.7) | 40(26.7) | Pre-term | ||
0.27 | 0(0) | 37(24.7) | BW<2700g | Birth Weight |
7(4.7) | 104(69.3) | 2700 |
||
0(0) | 2(1.3) | BM>4200 | ||
150(100) | Total |
Table 2. Hearing Loss Status of Participants
Number (percentage) |
Hearing Loss |
143 (95/3) |
Normal |
1(0/7) |
Slight |
0(0) |
Mild |
1(0/7) |
Moderate |
5(3/3) |
Moderately-Severe |
0(0) |
Severe |
0(0) |
Profound |
150(100) |
Total |
Table 3. Results of the Relationship between Research Variables and Hearing Disorders of Study Participants
P | Chi-Square | Abnormal ABR(ABR>25db) | Normal ABR (0-25db) | Study variables | |
0.01 | 10.31 | 3(2) | 94(62.7) | Under a week | Age at Infant Hospitalization |
3(2) | 11(7.3) | 1-2 weeks | |||
1 (0.7) | 19(12.7) | 2-3 weeks | |||
0(0) | 19(12.7) | More than three weeks | |||
0.55 | 0.36 | 0(0) | 7(4.7) | yes | Aminoglycoside Intake |
7(4.7) | 136(90.7) | no | |||
0.05 | 3.82 | 1(0.7) | 3(2) | yes | Family History of Hearing Disorders |
6(4) | 140(95.3) | no | |||
0.01 | 6.63 | 2(1.3) | 7(4.7) | yes | Oxygen Needs |
5(3.3) | 136(90.7) | no | |||
0.56 | 2.03 | 3(2) | 84(56) | Under a week | Days of Hospitalization |
4(2.7) | 47(31.3) | 1-2 weeks | |||
0(0) | 7(4.7) | 2-3 weeks | |||
0(0) | 5(3.3) | More than three weeks | |||
0.001 | 1.28 | 0(0) | 143(95.3) | Pass | OAE |
7(4.7) | 0(0) | Fail | |||
0.001 | 1.5 | 0(0) | 0(0) | Right ear | Hearing loss |
1(0.7) | 0(0) | Left ear | |||
6(4) | 0(0) | Both ears | |||
0(0) | 143(95.3) | None | |||
150(100) | Total | Total |
Discussion
Based on the results of this study, 63.3% of study participants were male, and 36.7% were female. Also, 64.7% of study participants were less than a week old at the time of hospitalization. There was no statistically significant correlation between the gestational age and the birth weight with hearing disorder (ABR test), which was consistent with some similar studies (16,17). However, in some other studies, there was a correlation between the gestational age and the birth weight with hearing disorder. There was a statistically significant difference that could be attributed to the large sample size of the studies, which is consistent with the results of this study (18–20). Similar research, studying factors related to hearing disorders, have reported ototoxic drugs, mechanical ventilation, and low Apgar score at one and five min of birth (21,22).
The results of this study showed that 3.3% of study participants had moderately-severe hearing loss. This finding is similar to a study conducted in high-risk newborns (23).
Based on the results of this study, the age of the patients at the time of hospitalization had significant statistical relationship with hearing disorders (ABR test), and the patients, who were less than two weeks old at the time of hospitalization, had more hearing disorder. This finding was less well-considered in similar studies. The results of this study showed the highest percentage of neonates hospitalized due to seizure. These findings are consistent with similar studies in neonatal hearing disorders, which have reported these seizures as one of the major causes of hearing disorder (12,22). The results of this study showed that none of the participants in the study had Furosemide consumption. Also, none of the participants in the study needed a respirator and none of the participants had a neuropathic audiometry. This finding was inconsistent with some similar studies. The different nature of the patients was the cause of this difference (12). Based on the results of this study, there is a significant relationship between the need for oxygen and the hearing disorders (ABR test), and those who needed oxygen showed greater hearing disorders. This finding has been less well-considered in similar studies; the cause of this issue can be of a different therapeutic nature and different types of treatment for patients treated in different studies. However, these findings are consistent with the results reported by Umehara et al. The results of their study showed that the factors contributing to the elevation of ABR threshold were oxygen administration (22). There was a statistically significant relationship between the two variables of OAE and ABR in the study, and the participants, who were diagnosed with hearing disorder via the ABR test, also failed their OAE test.
This direct relationship between the two tests may indicate that persons hospitalized and treated in NICUs need both tests (ABR and OAE) at birth to make a definitive diagnosis of hearing disorders. This finding was also mentioned in the study carried out by Di Stadio et al. (24). In their study, 95.3% of the participants had a healthy hearing, and based on the results, 4% of study participants had hearing disorders. They also showed disorder in both ears, and 4.7% of participants in the study had mild to severe hearing disorder. This finding is in line with some similar studies (9,25). It is recommended that programs be designed and implemented to inform ad follow up parents on the subject of hearing loss.
Conclusion
Two main dietary patterns (i.e., the DASH-style dietary pattern and the modern dietary pattern) were dominant in the nutrition patterns of patients with hypertension. The results showed that the modern dietary pattern was associated with higher SBP and, interestingly, that the DASH-style dietary pattern was not associated with lower levels of SBP or DBP. Hypertensive patients in both identified dietary patterns consumed more sodium and less potassium, calcium, and magnesium than expressed in the DASH recommendations. The evidence in this study suggests that following a healthy diet and achieving the recommended intake of effective nutrients such as calcium, magnesium, potassium, and sodium is necessary to reach beneficial outcomes. Another indirect but important finding of this study was that many hypertensive people receiving treatment for hypertension did not comply with the recommended healthy diet to control their high blood pressure. Hypertension with the high prevalence and incidence is known as a public health problem globally. The key role of a healthy diet (including micronutrients) in controlling high blood pressure, and the insufficient information available about the dominant diet in hypertensive people show that there is still room to conduct further research to address these issues. Future research to replicate the present findings using a prospective design is recommended.
Acknowledgements
This article results from the research design and financial support of the Vice President of Research and Technology of Hamadan University of Medical Sciences, so thanks for their support. Also, we would like to thank all the parents of the newborns for their contribution to this study.
Conflicts of Interest
Authors declared no conflict of interests.
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