Since the beginning of the COVID-19 pandemic, social distancing had a major impact on the mental health of the general population,1,2 with an increase in symptoms related to anxiety, depression, and post-traumatic stress disease (PTSD) compared with before the pandemic outbreak.3–5 Such was associated primarily with young age, female gender, and previous psychiatric illness,6 but also with loneliness, COVID-19-specific worry, and low distress tolerance.7 Other studies on the Chinese population showed how the prevalence of acute stress symptoms gradually declined with the progression of the epidemic, although that of anxiety and depression symptoms still stayed at high levels.8
Systemic sclerosis (SSc) is a chronic autoimmune disease characterized by fibrosis of skin and internal organs and vasculopathy, leading to severe physical impairment.9
A state of psychological fragility was notably found in people with chronic conditions during COVID-19 pandemic,10 including SSc patients. In such a population, a substantial increase in anxiety, but not depression symptoms compared to before the COVID-19 pandemic emerged, inversely related to adequacy of financial resources.11
Another crucial element for this population is fear due to COVID-19, as reported in a cohort of SSc patients from the United States, Canada, France, and the United Kingdom (UK) by a validated questionnaire.12 Higher levels of COVID-19-related fear were found in UK SSc patients and were associated with low economic intake and with a previous anxiety condition.13
Pandemic fear was described by patients as a major cause of missed outpatient visits, as emerged from a tele-survey of Indian Progressive Systemic Sclerosis Registry.14
For SSc patients, assiduous follow-up is essential to prevent or limit disease multi-organ involvement through appropriate diagnostic and therapeutic tools to achieve a better disease outcome.15
Anxiety and fear due to COVID-19 thus emerged as marking psychological fragility in SSc patients in the course of the current pandemic. Therefore, the aim of the present work is to assess their prevalence among SSc patients during the second and third waves of the SARS-CoV-2 pandemic in Italy using validated questionnaires, and to investigate possible associated factors.
Materials and Methods
We performed a cohort study on 114 consecutive patients with SSc referring to the Scleroderma Clinic of Policlinico Umberto I in Rome, Italy. During the period from October 2020 to March 2021, a new rise in the RT index (the average number of new infections caused by a single infected individual at time t in the susceptible population16) was registered and stricter lockdown measures have been applied.17 We selected 28 patients who had not attended the scheduled examination and 86 subjects who had performed regular outpatient visits during the same period, matched for sex and age. Both groups were administered (respectively by telephone or in-person) the Generalized Anxiety Disorder Scale-7 (GAD-7) questionnaire, used in patients with pre-existing medical conditions during the COVID-19 pandemic, and the COVID-19 Fears Questionnaire for Chronic Medical Conditions (COVID-19 Fears), developed and validated on SSc patients of Scleroderma Patient-centered Intervention Network (SPIN) COVID-19 cohort study.12,18,19 The GAD-7 is a 7-item scale reporting score from 0 to 3 on all the questions. It investigates how often the patient has been bothered by seven different symptoms of anxiety during the last 2 weeks with response options such as “not at all”, “several days ‘, “more than half the days”, and “nearly daily” scored as 0, 1, 2, and 3, respectively. The scores of 5, 10, and 15 are taken as cut-off points for mild, moderate, and severe anxiety, respectively. A score of 8 points or more is a reasonable cut-off for needing further evaluation to determine the presence and type of anxiety disorder.18 The GAD-7 has been found to have great psychometric properties and is short and easy to administer19 (Table 1). The COVID-19 fears is a 10-item scale measure assessing pandemic-related fears among vulnerable patients due to pre-existing illnesses. It evaluates fears of social isolation, adequate care of chronic conditions during the pandemic, greater risk of the COVID-19 complications due to medical conditions and fear of COVID-19 infection (Table 2).12 Finally, an analysis of possible factors associated with higher questionnaire scores in patients who did not have outpatient follow-up was conducted, such as age, disease activity reported by patients, ongoing therapy for anxiety/depression, current work status, and living alone.12 This study complies with the Declaration of Helsinki. The Sapienza University of Rome – Policlinico Umberto I ethic committee has approved (institutional review board approval n° 6364) the study, and informed consent has been obtained from the subjects.
Table 2 10-Item COVID-19 Fears Questionnaire for Chronic Medical Conditions (COVID-19 Fears), Validated on Population of Patients with Systemic Sclerosis
Statistical Analysis
Statistical analysis of the result was performed using GraphPad Prism 8 for Windows. Qualitative variables were described as frequencies and percentages, continuous variables as medians and interquartile ranges, and assessed by chi-square test (χ2 test) and Fisher’s exact test, as appropriate. For the comparison of ordinal values between independent sample Mann–Whitney test for paired or unpaired samples was used. Multivariate linear regression analysis was used to adjust the association between a continuous dependent variable and independent variables for potential confounders.
Results
The study population consisted of 114 consecutive SSc patients. Of the 28 patients who did not perform outpatient visits during the selected period, 27 were female and the median age [quartiles] was 64 [55.25;70] years. Among 86 patients who performed regular follow-up, 78 were female and the median age [quartiles] was 60 [61.5;67] years. The first group had statistically significant more patients scoring ≥8 on the GAD-7 questionnaire (22/78.6% vs 16/18.6%, p<0.0001) and recorded higher scores both on GAD-7 (median [quartiles] 10.5 [8.25;14] vs 4 [0;7], p<0.0001) and COVID-19 Fears (median [quartiles] 31.5 [26.25;37.25] vs 20 [13.75;28], p<0.0001) than the second group. More attending group patients self-reported a worsening of SSc symptoms than missing group ones (26/30.3% vs 3/10.7, p=0.0039) (Table 3). On multivariate analysis performed on missing group patients, lack of work and ongoing therapy for anxiety/depression showed a significant association with GAD-7 (p=0.0275 and p=0.0188) and COVID-19 Fears score (p=0.0016 and p=0.0099) (Tables 4 and 5). The multivariate analysis performed on all the 114 patients, considering GAD-7 and COVID-19 Fear scores as dependent variables, showed statistically significant associations with anxiety/depression therapy assumption (p=0.0010 and p=0.0137, respectively).
Table 3 Characteristics of Study Population
Table 4 Multivariate Analysis Performed on 28 Patients Who Missed Scheduled Appointments Considering GAD-7 Score as the Dependent Variable
Table 5 Multivariate Analysis Performed on 28 Patients Who Missed Scheduled Appointments Considering COVID-19 Fears Score as the Dependent Variable
Discussion
Patients with SSc represent a high-risk population for complications related to COVID-19 due to the presence of fragility and immunosuppressant drug use,20,21 where a higher prevalence of SARS-CoV-2 infection related to lung involvement resulted.22 The presence of interstitial lung disease and ongoing immunosuppressive treatment may place patients with SSc at risk of developing more severe disease and higher mortality when infected with SARS-CoV-2.23,24 Since the beginning of the pandemic, the need to balance patients’ safety with the necessity for frequent medical check-ups became apparent, as well as a growing interest in the psychological fragility of SSc patients emerged.25 In Italy, during the pandemic progression, additional waves of the epidemic occurred, making it necessary the reintroduction of stricter restrictive measures. Of note, psychological consequences showed a correlation with the length of isolation time.26
Our study shows that anxiety disorder and fear related to COVID outbreak are greater in patients with SSc who have not attended scheduled appointments, and they are associated with lack of work activity and ongoing therapy for anxiety/depression. Our results are in line with the multicentric Scleroderma Patient-centred Intervention Network (SPIN) COVID-19 cohort study, in which SSc patients presented a rise in anxiety symptoms compared to pre-COVID-19 era, with no significant increase in depression symptoms and with the adequacy of financial resources associated with a better outcome.11 Similar results emerged from Indian Progressive Systemic Sclerosis Registry, where the pandemic fear was a cause of missed outpatients visits and job loss was found associated to a self-reported worsening of disease.14 Another work from the SPIN COVID-19 cohort showed that variables associated with COVID-19 fear were interference of breathing problems in daily activities, financial resources inadequacy, and high levels of previous anxiety.13
Our study identifies for the first-time higher amounts of COVID-19-related fear and generalized anxiety disorder symptoms in the subgroup of SSc patients who missed regular visits, evidenced by validated questionnaires. These patients deserve attention regarding the presence of risk factors for missed periodic check-ups, whose regularity should be ensured as recommended by the World Scleroderma Foundation.27 As emerged in the Taiwan population, high anxiety and COVID-19 worry resulted associated with non-attendance to the scheduled appointment.28 Such result stressed the need for intervention strategies regarding the mental health of this patient’s group. An example in this way is the SPIN COVID-19 Home-Isolation Activities Together (SPINCHAT) Program, a group-based intervention delivered by video conference and intended to reduce anxiety among at-risk people with SSc, whose results are in progress.29 Other strategies to address patient concerns were and still are applied, such as telemedicine or home delivery drugs.30
A partially encouraging finding is that more regular attendees reported a worsening of SSc symptoms, and this gives hope that, at least for this group of at-risk patients, regular check-ups will be guaranteed. Maybe patients who are worse off are keener to comply than controls and more worried about their current autoimmune disease than about the risk of viral infection.31 Besides, the reason for this behaviour can be also due to the more difficult management of their clinical state remotely.
Conclusion
A limitation of the present work is the small size of the cohort of missing patients, with the impossibility to make a further stratification. On the other hand, strengths are the choice of a homogeneous population and the application of a questionnaire validated for SSc patients.
On that note, what we learned from our present study is that the possible arising of psychosocial disabilities and deterioration in the quality of life should be taken into account. We expect that the results obtained so far will allow focusing on the psychological fragility of SSc patients, to provide the necessary follow-up and treatment, thus preventing their disease from worsening during such a particular long-lasting historical period.
Data Sharing Statement
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.
Ethics Statement
This study complies with the Declaration of Helsinki. The Sapienza University of Rome – Policlinico Umberto I ethic committee has approved (institutional review board approval n° 6364) the study and written (or oral for patients reached by telephone) informed consent has been obtained from the subjects.
Acknowledgment
Data of the present manuscript were presented at 58° Italian Rheumatology Congress, PO:09:163, Reumatismo 2021, Vol. 73, N° 4 (Special number 2).
Author Contributions
All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.
Disclosure
The authors declare they have no conflicts of interest.
References
1. Wang C, Pan R, Wan X, et al. A longitudinal study on the mental health of the general population during the COVID-19 epidemic in China. Brain Behav Immun. 2020;87:40–48. PMID: 32298802; PMCID: PMC7153528. doi:10.1016/j.bbi.2020.04.028
3. Castellini G, Rossi E, Cassioli E, et al. A longitudinal observation of general psychopathology before the COVID-19 outbreak and during lockdown in Italy. J Psychosom Res. 2021;141:110328. PMID: 33316632; PMCID: PMC7716728. doi:10.1016/j.jpsychores.2020.110328
4. Di Crosta A, Palumbo R, Marchetti D, et al. Individual differences, economic stability, and fear of contagion as risk factors for PTSD symptoms in the COVID-19 emergency. Front Psychol. 2020;11:567367. PMID: 33013604; PMCID: PMC7506146. doi:10.3389/fpsyg.2020.567367
5. Georgieva I, Lepping P, Bozev V, et al. Prevalence, new incidence, course, and risk factors of PTSD, depression, anxiety, and panic disorder during the covid-19 pandemic in 11 Countries. Healthcare. 2021;9(6):664. PMID: 34204925; PMCID: PMC8227861. doi:10.3390/healthcare9060664
6. Xiong J, Lipsitz O, Nasri F, et al. Impact of COVID-19 pandemic on mental health in the general population: a systematic review. J Affect Disord. 2020;277:55–64. PMID: 32799105; PMCID: PMC7413844. doi:10.1016/j.jad.2020.08.001
7. Liu CH, Zhang E, Wong GTF, Hyun S, Hahm HC. Factors associated with depression, anxiety, and PTSD symptomatology during the COVID-19 pandemic: clinical implications for U.S. young adult mental health. Psychiatry Res. 2020;290:113172. PMID: 32512357; PMCID: PMC7263263. doi:10.1016/j.psychres.2020.113172
8. Li W, Zhang H, Zhang C, et al. The prevalence of psychological status during the COVID-19 epidemic in China: a systemic review and meta-analysis. Front Psychol. 2021;12:614964. PMID: 34017278; PMCID: PMC8129549. doi:10.3389/fpsyg.2021.614964
10. Buneviciene I, Bunevicius R, Bagdonas S, Bunevicius A. The impact of pre-existing conditions and perceived health status on mental health during the COVID-19 pandemic. J Public Health. 2021:fdab248. PMID: 34179996. doi:10.1093/pubmed/fdab248
11. Thombs BD, Kwakkenbos L, Henry RS, et al. Changes in mental health symptoms from pre-COVID-19 to COVID-19 among participants with systemic sclerosis from four countries: a Scleroderma Patient-centered Intervention Network (SPIN) Cohort study. J Psychosom Res. 2020;139:110262. PMID: 33070043; PMCID: PMC7532799. doi:10.1016/j.jpsychores.2020.110262
12. Wu Y, Kwakkenbos L, Henry RS, et al. Validation of the COVID-19 fears questionnaires for chronic medical conditions: a scleroderma patient-centered intervention network COVID-19 cohort study. J Psychosom Res. 2020;139:110271. PMID: 33096402; PMCID: PMC7543945. doi:10.1016/j.jpsychores.2020.110271
13. Wu Y, Kwakkenbos L, Henry RS, et al. Factors associated with fears due to COVID-19: a Scleroderma Patient-centered Intervention Network (SPIN) COVID-19 cohort study. J Psychosom Res. 2021;140:110314. PMID: 33271402; PMCID: PMC7685938. doi:10.1016/j.jpsychores.2020.110314
14. Kavadichanda C, Shobha V, Ghosh P, et al. Clinical and psychosocioeconomic impact of COVID-19 pandemic on patients of the Indian Progressive Systemic Sclerosis Registry (IPSSR). Rheumatol Adv Pract. 2021;5(2):rkab027. PMID: 34095747; PMCID: PMC8135468. doi:10.1093/rap/rkab027
15. Allanore Y, Simms R, Distler O, et al. Systemic sclerosis. Nat Rev Dis Primers. 2015;1(1):15002. PMID: 27189141. doi:10.1038/nrdp.2015.2
16. Rodpothong P, Auewarakul P. Viral evolution and transmission effectiveness. World J Virol. 2012;1(5):131–134. PMID: 24175217; PMCID: PMC3782273. doi:10.5501/wjv.v1.i5.131
18. Sapra A, Bhandari P, Sharma S, Chanpura T, Lopp L. Using Generalized Anxiety Disorder-2 (GAD-2) and GAD-7 in a primary care setting. Cureus. 2020;12(5):e8224. PMID: 32582485; PMCID: PMC7306644. doi:10.7759/cureus.8224
19. Xu Z, Zhang D, Xu D, et al. Loneliness, depression, anxiety, and post-traumatic stress disorder among Chinese adults during COVID-19: a cross-sectional online survey. PLoS One. 2021;16(10):e0259012. PMID: 34673812; PMCID: PMC8530321. doi:10.1371/journal.pone.0259012
20. Orlandi M, Lepri G, Damiani A, et al. One year in review 2020: systemic sclerosis. ClinExpRheumatol. 2020;38(3):3–17.
22. Ferri C, Giuggioli D, Raimondo V, et al. Covid-19 And rheumatic autoimmune systemic diseases: role of pre-existing lung involvement and ongoing treatments. Curr Pharm Des. 2021;27(41):4245–4252. PMID: 34477509. doi:10.2174/1381612827666210903103935
23. Avouac J, Airó P, Carlier N, Matucci-Cerinic M, Allanore Y. Severe COVID-19-associated pneumonia in 3 patients with systemic sclerosis treated with rituximab. Ann Rheum Dis. 2020. doi:10.1136/annrheumdis-2020-217864
24. Mariano RZ, Del Rio APT, Reis F. COVID-19 overlapping with systemic sclerosis. Rev Soc Bras Med Trop. 2020;53:1–6. doi:10.1590/0037-8682-0450-202014
25. Orlandi M, Lepri G, Bruni C, et al. The systemic sclerosis patient in the COVID-19 era: the challenging crossroad between immunosuppression, differential diagnosis and long-term psychological distress. Clin Rheumatol. 2020;39(7):2043–2047. PMID: 32514674; PMCID: PMC7276334. doi:10.1007/s10067-020-05193-2
26. Namdar P, Mojabi NA, Mojabi B. Neuropsychological and psychosocial consequences of the COVID-19 pandemic. Neurophysiology. 2021:1–10. PMID: 34400849; PMCID: PMC8357964. doi:10.1007/s11062-021-09903-7
27. Matucci-Cerinic M, Bruni C, Allanore Y, et al. Systemic sclerosis and the COVID-19 pandemic: world scleroderma foundation preliminary advice for patient management. Ann Rheum Dis. 2020;79(6):724–726. PMID: 32349982. doi:10.1136/annrheumdis-2020-217407
28. Hsieh YP, Yen CF, Wu CF, Wang PW. Nonattendance at scheduled appointments in outpatient clinics due to COVID-19 and related factors in Taiwan: a health belief model approach. Int J Environ Res Public Health. 2021;18(9):4445. PMID: 33922171; PMCID: PMC8122706. doi:10.3390/ijerph18094445
29. Thombs BD, Kwakkenbos L, Carrier ME, et al. Protocol for a partially nested randomised controlled trial to evaluate the effectiveness of the scleroderma patient-centered intervention network COVID-19 home-isolation activities together (SPIN-CHAT) program to reduce anxiety among at-risk scleroderma patients. J Psychosom Res. 2020;135(110132). PMID: 32521358; PMCID: PMC7224675. doi:10.1016/j.jpsychores.2020.110132
30. Minniti A, Maglione W, Pignataro F, Cappadona C, Caporali R, Del Papa N. Taking care of systemic sclerosis patients during COVID-19 pandemic: rethink the clinical activity. Clin Rheumatol. 2020;39(7):2063–2065. PMID: 32462423; PMCID: PMC7251048. doi:10.1007/s10067-020-05191-4
31. Pellegrino G, Mohammad Reza Beigi D, Angelelli C, et al. COVID-19 and systemic sclerosis: analysis of lifestyle changes during the SARS-CoV-2 pandemic in an Italian single-center cohort. Clin Rheumatol. 2021;40(4):1393–1397. PMID: 33188620; PMCID: PMC7666573. doi:10.1007/s10067-020-05504-7
The Canadian government says it will donate up to 200,000 vaccine doses to fight the mpox outbreak in Congo and other African countries.
It says the donated doses of Imvamune will come from Canada’s existing supply and will not affect the country’s preparedness for mpox cases in this country.
Minister of Health Mark Holland says the donation “will help to protect those in the most affected regions of Africa and will help prevent further spread of the virus.”
Dr. Madhukar Pai, Canada research chair in epidemiology and global health, says although the donation is welcome, it is a very small portion of the estimated 10 million vaccine doses needed to control the outbreak.
Vaccine donations from wealthier countries have only recently started arriving in Africa, almost a month after the World Health Organization declared the mpox outbreak a public health emergency of international concern.
A few days after the declaration in August, Global Affairs Canada announced a contribution of $1 million for mpox surveillance, diagnostic tools, research and community awareness in Africa.
On Thursday, the Africa Centres for Disease Control and Prevention said mpox is still on the rise and that testing rates are “insufficient” across the continent.
Jason Kindrachuk, Canada research chair in emerging viruses at the University of Manitoba, said donating vaccines, in addition to supporting surveillance and diagnostic tests, is “massively important.”
But Kindrachuk, who has worked on the ground in Congo during the epidemic, also said that the international response to the mpox outbreak is “better late than never (but) better never late.”
“It would have been fantastic for us globally to not be in this position by having provided doses a much, much longer time prior than when we are,” he said, noting that the outbreak of clade I mpox in Congo started in early 2023.
Clade II mpox, endemic in regions of West Africa, came to the world’s attention even earlier — in 2022 — as that strain of virus spread to other countries, including Canada.
Two doses are recommended for mpox vaccination, so the donation may only benefit 100,000 people, Pai said.
Pai questioned whether Canada is contributing enough, as the federal government hasn’t said what percentage of its mpox vaccine stockpile it is donating.
“Small donations are simply not going to help end this crisis. We need to show greater solidarity and support,” he said in an email.
“That is the biggest lesson from the COVID-19 pandemic — our collective safety is tied with that of other nations.”
This report by The Canadian Press was first published Sept. 13, 2024.
Canadian Press health coverage receives support through a partnership with the Canadian Medical Association. CP is solely responsible for this content.
HALIFAX – The Nova Scotia government says it could be months before it reveals how many people are on the wait-list for a family doctor.
The head of the province’s health authority told reporters Wednesday that the government won’t release updated data until the 160,000 people who were on the wait-list in June are contacted to verify whether they still need primary care.
Karen Oldfield said Nova Scotia Health is working on validating the primary care wait-list data before posting new numbers, and that work may take a matter of months. The most recent public wait-list figures are from June 1, when 160,234 people, or about 16 per cent of the population, were on it.
“It’s going to take time to make 160,000 calls,” Oldfield said. “We are not talking weeks, we are talking months.”
The interim CEO and president of Nova Scotia Health said people on the list are being asked where they live, whether they still need a family doctor, and to give an update on their health.
A spokesperson with the province’s Health Department says the government and its health authority are “working hard” to turn the wait-list registry into a useful tool, adding that the data will be shared once it is validated.
Nova Scotia’s NDP are calling on Premier Tim Houston to immediately release statistics on how many people are looking for a family doctor. On Tuesday, the NDP introduced a bill that would require the health minister to make the number public every month.
“It is unacceptable for the list to be more than three months out of date,” NDP Leader Claudia Chender said Tuesday.
Chender said releasing this data regularly is vital so Nova Scotians can track the government’s progress on its main 2021 campaign promise: fixing health care.
The number of people in need of a family doctor has more than doubled between the 2021 summer election campaign and June 2024. Since September 2021 about 300 doctors have been added to the provincial health system, the Health Department said.
“We’ll know if Tim Houston is keeping his 2021 election promise to fix health care when Nova Scotians are attached to primary care,” Chender said.
This report by The Canadian Press was first published Sept. 11, 2024.
ST. JOHN’S, N.L. – Newfoundland and Labrador‘s chief medical officer is monitoring the rise of whooping cough infections across the province as cases of the highly contagious disease continue to grow across Canada.
Dr. Janice Fitzgerald says that so far this year, the province has recorded 230 confirmed cases of the vaccine-preventable respiratory tract infection, also known as pertussis.
Late last month, Quebec reported more than 11,000 cases during the same time period, while Ontario counted 470 cases, well above the five-year average of 98. In Quebec, the majority of patients are between the ages of 10 and 14.
Meanwhile, New Brunswick has declared a whooping cough outbreak across the province. A total of 141 cases were reported by last month, exceeding the five-year average of 34.
The disease can lead to severe complications among vulnerable populations including infants, who are at the highest risk of suffering from complications like pneumonia and seizures. Symptoms may start with a runny nose, mild fever and cough, then progress to severe coughing accompanied by a distinctive “whooping” sound during inhalation.
“The public, especially pregnant people and those in close contact with infants, are encouraged to be aware of symptoms related to pertussis and to ensure vaccinations are up to date,” Newfoundland and Labrador’s Health Department said in a statement.
Whooping cough can be treated with antibiotics, but vaccination is the most effective way to control the spread of the disease. As a result, the province has expanded immunization efforts this school year. While booster doses are already offered in Grade 9, the vaccine is now being offered to Grade 8 students as well.
Public health officials say whooping cough is a cyclical disease that increases every two to five or six years.
Meanwhile, New Brunswick’s acting chief medical officer of health expects the current case count to get worse before tapering off.
A rise in whooping cough cases has also been reported in the United States and elsewhere. The Pan American Health Organization issued an alert in July encouraging countries to ramp up their surveillance and vaccination coverage.
This report by The Canadian Press was first published Sept. 10, 2024.
