Cross-sectional evaluation of socioeconomic and clinical factors and the impact of fibromyalgia on the quality of life of patients during the COVID-19 pandemic

Abstract BACKGROUND: The fibromyalgia impact questionnaire (FIQ) relates to the functional capacity, professional situation, psychological disorders, and physical symptoms, and can identify the factors that determine the impact of the syndrome and characteristics of its carriers; the higher the score, the greater the impact of fibromyalgia on the quality of life. OBJECTIVE: To evaluate the impact of fibromyalgia on the quality of life of individuals with fibromyalgia, who were categorized according to the FIQ during the coronavirus disease pandemic. DESIGN AND SETTING: A cross-sectional study was conducted at an institution of higher education in Taquara, RS, Brazil. METHODS: A quantitative study was carried out, with the application of a sociodemographic and clinical questionnaire, and the FIQ in 163 Brazilian individuals with a medical diagnosis of fibromyalgia. Data were collected using SurveyMonkey software. RESULTS: Of the female carriers, 98.2% were living in urban areas, working, and under pharmacological and complementary treatment. The FIQ results showed that seven of the 10 items had the maximum score. The items “physical function” and “feel good” had intermediate scores, and the item “missed work” had a low score. The average total score was 79.9 points, indicating that fibromyalgia had a severe impact on the participants’ lives. A severe impact of fibromyalgia was observed in 61.3% of the participants, a moderate impact in 30.7%, and a low impact in 8%. CONCLUSION: The survey findings suggest a severe impact in the majority of the Brazilian fibromyalgic population.


INTRODUCTION
Fibromyalgia is a complex systemic disorder characterized by diffuse pain, fatigue, anxiety and depression, among other symptoms. 1 Approximately 2.1% of the population is a carrier of fibromyalgia worldwide; however, it should be noted that regional differences can be observed. 2,3 A prevalence of 6.1% was observed in the United States, 4 while similar proportions to those worldwide were observed in Spain and Brazil (2.6% and 2%, respectively). 5,6 Moreover,this syndrome is more prevalent in women. 2 Diffuse pain is the symptom that prevails in patients with fibromyalgia; additionally, it is difficult to accurately assess its intensity, since pain is perceived subjectively and individually. 7 The symptoms can increase according to modulating factors, such as climate change, 8 degree of physical activity, and high stress levels, 9 such as those experienced throughout the year 2020 with the confrontation of the global pandemic of coronavirus disease   10 by the reduction of social contact, leisure activities, financial concern, and with the health of friends and family members. 11,12 Regarding the consequences of the syndrome, fibromyalgia has a direct influence on the mental health of the carrier, since the fewer symptoms the patient presents, the closer to a positive mental health model the patient will be. 13 A concept linked to mental health is the quality of life, defined by the World Health Organization as an individual's perception of their position in life, in their own context and in relation to their goals and expectations. 14 To assess the quality of life of patients with fibromyalgia, several instruments can be used, including the fibromyalgia impact questionnaire (FIQ), which relates to the functional capacity, work situation, psychological disorders, and physical symptoms. It is a very useful tool that can identify the factors that determine the impact and collaborate to define the best treatment. 15 However, it is often used incompletely and does not explore the categorization of the scores obtained individually by the participants. As fibromyalgia negatively impacts different aspects of the lives of individuals affected by the syndrome, it is of utmost importance to understand the profile and characteristics of its carriers and how often different impacts occur in the populations studied.

OBJECTIVE
This study aimed to assess the impact of fibromyalgia on the lives of individuals with the syndrome during the COVID-19 pandemic as well as to map the socioeconomic and clinical factors associated with this diagnosis. It is the first study to present the Brazilian frequencies in a categorized way according to the FIQ.

Study design
A cross-sectional, quantitative study was conducted, with the application of a sociodemographic and clinical questionnaire and the fibromyalgia impact questionnaire (FIQ). This study was approved as per the certificate of presentation of ethical appre-

Population and sample
We included Brazilian individuals (living in Brazil or not) with a medical diagnosis of fibromyalgia and older than 18 years of age.
Participants who agreed to participate in the study but did not answer the questionnaire were excluded.
To calculate the sample size, the effect of fibromyalgia on the lives of patients with the syndrome was the primary outcome. As no studies were found that evaluated the ratio of severe impact on the lives of the study population, an estimated 50% of individuals suffering from a severe impact on their lives were included for the sample size calculation. A confidence level of 95% was adopted with a maximum error of 8%; additionally, the calculated sample size was 151 individuals. An additional 15% was included in the sample to minimize the possible sample losses for a total intended sample size of 173 subjects.
The participants completed digital questionnaires generated on the SurveyMonkey platform (Momentive, San Mateo, California, United States; https://pt.surveymonkey.com), from August to October 2020, during the third quarter of the COVID-19 pandemic in Brazil. The sample was selected, and access to the questionnaires was provided through social media.
The FIQ version that was validated in Brazil was applied.
This questionnaire aimed to evaluate the quality of life of patients with fibromyalgia and was composed of 19 questions organized into 10 items. All the items were measured by a visual scale corresponding to values from 0 to 10 (0 = the best possible and 10 = the worst possible). 17 To obtain the total score, the individual scores of the first three items were properly recoded by a rule of three to ten points per item; subsequently, they were added to the next seven items. If any question was left blank, the scores obtained were summed and divided by the number of questions answered. 18 The total FIQ scores ranged from 0 to 100, where higher values indicated a greater negative impact of the syndrome, and were be classified into the following categories: low impact (< 50 points), moderate impact (50-75 points), and severe impact (> 75 points). 19

Statistical analysis
The Statistical Package for Social Science Professional software (version 25.0; IBM Corp., Armonk, New York, United States) was used for data analysis. The mean and standard deviation were used to describe parametric continuous variables; additionally, the median and interquartile range were used for nonparametric variables, while absolute and relative frequencies were used for categorical variables. The Shapiro-Wilk test was used to test the normality of the data; furthermore, the chi-square test was used to assess the difference in proportions between the FIQ categories.

RESULTS
A total of 173 acceptances were obtained for participation in the survey; however, only 163 participants completed the questionnaires. The general characteristics of the participants are presented in Table 1. The questionnaires were answered by 160 women and three men, aged between 19 and 63 years.
Considering the impact of fibromyalgia, 13 subjects, who were evaluated as having low impact, that is, 100% of this group, lived in urban areas. Similarly, 49 subjects with moderate impact and 96 subjects with severe impact, equal to 98% and 96% of the total in each group, respectively, also lived in urban areas.
Clinical data of the participants are presented in Table 2.
The participants had a symptom onset between 7 and 50 years of age and between 13 and 52 years of age at diagnosis. The time of illness, current age, age at diagnosis, and age at symptom onset did not seem to be related to the category of impact according to the FIQ of the participants. The age of the participants with low impact, moderate impact, and severe impact was 37.08 ± 8.30 years, 39.22 ± 9.28 years, and 38.93 ± 9.09 years (P = 0.798), respectively; the age of symptom onset of participants with low impact, moderate impact, and severe impact was 29.69 ± 12.23 years, 29.14 ± 9.23 years, 28.02 ± 9.59 years (P = 0.306), respectively; the age at diagnosis of participants with low impact, moderate impact, and severe impact was 32.91 ± 8.62 years, 34.40 ± 8.48 years, and 34.14 ± 8.73 years (P = 0.895), respectively; the length of illness since diagnosis for participants with low impact, moderate impact, and severe impact was 4 (0-5) years, 3 (1-6) years, and severe 3 (1-6) years (P = 0.214), respectively; and the length of illness from the onset of symptoms for participants with low impact, moderate impact, and severe impact was 5 (3-9) years, 8 (4-16) years and 9 (4-15) years (P = 0.352), respectively.
Regarding the symptoms of fibromyalgia, it is important to note that the impact of fibromyalgia does not seem to be related to symptoms, namely localized pain (low -13, 100%; moderate -45, 90%; and severe -93, 93%; P = 0.458), memory loss (low -11, 84.6%; moderate 38, 76.0%; and severe -87, 87.0%; P = 0.231), tingling (low -7, 53.8%; moderate -37, 74.0%; and severe -79, 79.0%;     21 This fact suggests that most carriers suffer from a severe impact of the syndrome. It is important to emphasize that the more pain the patient reports, the higher the FIQ score and consequently, the worse the quality of life of that individual will be. 22 Contrastingly, patients who have low impact due to fibromyalgia have better acceptance of their pain than those with severe impact. 23 An important observation to be made is that when the participant was asked about the impact of fibromyalgia on their life, 67.5% indicated having a severe impact, which was not far from the results found by the FIQ, which showed that 61.3% of participants have severe impact. This demonstrated an accurate self-perception of the participant with respect to their condition. In addition, notably, there seems to be a link between self-awareness related to the syndrome and management of the crises generated by it with the FIQ scores, which are lower in carriers who have this control. 6 High frequencies of depressive and anxiety symptoms are also found in carriers of fibromyalgia, 24 noting that these symptoms occur in greater intensity in those in whom fibromyalgia causes a severe impact. 25 In the present study, no analysis was performed with specific questionnaires for depression and anxiety; however, in the clinical questionnaire, more than 70% of the participants reported having memory loss, even though no relationship was observed with the fibromyalgia impact group. In addition, a higher frequency of anxiety, difficulty in concentrating, and sleep disturbances was observed among those with the highest impact.
Regarding the emotional aspects of the syndrome, we observed a high proportion of individuals participating in this study who reported not knowing the origin of the onset of their symptoms.
However, of those who did know, 65 participants (39.4% of the total) reported an emotional relationship, either depression or emotional trauma, and most of them were individuals categorized by the FIQ as being severely impacted by fibromyalgia.
The data collection period corresponded to the third quarter of the COVID-19 pandemic in Brazil. This could be related to the high severity of fibromyalgia found in the study subjects.
Therefore, besides the fact that the presence of the viral infection itself (a parameter not evaluated in the clinical questionnaire applied) seems to worsen all domains of the FIQ in fibromyalgia patients, 26 the potential aggravation of stress and fear caused by the pandemic on the symptoms faced by fibromyalgia sufferers is discussed. 27 Hausmann et al. observed substantial changes in the employment status in their study sample and linked this to decreased access to fibromyalgia health care and treatment during the pandemic. 28 With respect to work, a study conducted in 2020 in Saudi Arabia found a high prevalence of fibromyalgia sufferers among healthcare workers. 29 The frontline healthcare workers for COVID-19 had to deal directly with an overload of work, being drastically affected by emotional stress, causing depression and anxiety. 30 These factors are related to the management of fibromyalgia and, as previously mentioned, with a high frequency in the group severely impacted by the syndrome. Although the present study did not access the participants' areas of expertise, this could be a factor that may have influenced the results obtained. In addition to those who worked directly with healthcare in the pandemic, the confinement situation adopted by several countries forced many patients to discontinue their treatments 31 and exacerbated the main symptoms of fibromyalgia. 32 Moreover, some authors found no influence of the pandemic on the clinical manifestations of fibromyalgia, 33 keeping this question open.
The fact that more than 90% of the participants reside in an urban area is in agreement with a previous study that showed that a greater number of individuals with fibromyalgia live in urban areas, with a prevalence ranging between 0.69% and 11.4%, higher than in a rural area that showed a prevalence between 0.6% and 5.2% of the population. 3 36 Additionally, although a high adherence to acupuncture has not been found in the present results, this therapy proves to be very efficient for pain reduction 37 and pain threshold increase 38 among the non-pharmacological treatment modalities.
Another category of non-pharmacological supportive treatment used by some of the participants was physical exercise, which demonstrates an improvement of fibromyalgia symptoms and mainly imparts a willingness to perform daily activities. 39 It has been shown that training with stretching exercises, strength training, and aerobic training for at least 60 min, 3 times a week, can improve the patient's condition 40 and that walking brings benefits in the quality of sleep. 41 Even an umbrella systematic review confirmed an improvement in pain, quality of life, physiological function, and psychological function of fibromyalgia patients by the practice of physical exercise. 42 Among the medications used today are those that can modulate some specific neurotransmitters, such as noradrenaline, serotonin, gamma-aminobutyric acid, opioid receptors, and calcium channel blockers, among others. 43 Moreover, although we did not assess which medications are part of the treatment of the interviewed individuals, we obtained results that show that most of the interviewed individuals use at least one drug combination.
A limitation of this study is the lack of use of a comparative tool for general quality of life measurements. In addition, although the study is quite comprehensive from a regional point of view, it may have a search bias, since, possibly, patients impacted by their condition will be concerned about participating in research. Likewise, the fact that the subjects filled out the questionnaires themselves may have generated differences in the interpretation of the questions and collection of the answers.
Moreover, as previously discussed, the period chosen for data collection may have increased the scores obtained because of the COVID-19 pandemic, and future studies are essential to visualize the consequent effects.

CONCLUSION
In the evaluated sample, we observed a higher frequency of the severe impact category, as well as a higher FIQ score during the observation during the COVID-19 pandemic, which demonstrates a poor quality of life in these individuals. In addition, the majority of fibromyalgia patients are women who live in urban areas, work, and use pharmacological and complementary treatments. A higher frequency of anxiety, difficulty concentrating, and sleep disturbances were related to a severe impact.
Moreover, even if individuals practice some physical activity, fibromyalgia is observed to severely affect their lives.