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 1 Generalized Anxiety Disorder Scale-7 (GAD-7) Questionnaire.
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 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.
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
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.
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.
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.
Data of the present manuscript were presented at 58° Italian Rheumatology Congress, PO:09:163, Reumatismo 2021, Vol. 73, N° 4 (Special number 2).
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.
The authors declare they have no conflicts of interest.
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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
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9. Denton CP, Khanna D. Systemic sclerosis. Lancet. 2017;390(10103):1685–1699. PMID: 28413064. doi:10.1016/S0140-6736(17)30933-9
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
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Canadian Blood Services in talks around paid donations of plasma as supply dwindles
Canadian Blood Services is in talks with companies that pay donors for plasma as it faces a decrease in collections.
The blood-collection agency issued a statement on Friday saying it is in “ongoing discussion with governments and the commercial plasma industry” on how to more than double domestic plasma collection to 50 per cent of supply.
Canadian Blood Services has previously cautioned that letting companies trade cash for plasma — a practice banned in British Columbia, Ontario and Quebec — could funnel donors away from voluntary giving.
The bulk of the non-profit agency’s supply currently comes from abroad, including via organizations that pay donors.
It issued a plea earlier this week for donors to book and keep appointments, noting collections have been falling since July 1 despite a constant need for plasma in transfusions for surgery, cancer patients and accident victims.
The number of people who donate blood regularly dropped by 31,000 during the COVID-19 pandemic, leaving the organization with its smallest donor base in a decade, it said.
The agency has opened five new plasma donor centres in the last few years, with six more planned by 2024 in an effort to draw 25 per cent of its supply from Canadian donors.
“But this only gets us halfway there. More needs to be done,” Canadian Blood Services said in the statement.
Working with private partners may offer one way to reach the 50 per cent threshold.
“Any options considered must necessarily include controls to ensure plasma collected in Canada is used exclusively to manufacture immunoglobulins for patients in Canada, while also ensuring no negative impacts on Canadian Blood Services’ current and future blood and plasma collections network,” the agency said.
It said Monday it had only four days’ worth of O+ blood type supply and five days’ worth of O- and B- blood types.
The O- type is the one most commonly used in transfusions for traumas and emergency surgeries, since anyone can receive its red blood cells. The O+ blood type is also in high demand due to its compatibility with any other positive red blood cell.
Spokeswoman Delphine Denis said ongoing illness and isolation requirements related to COVID-19, heat-related weather issues and the return of pre-pandemic activities and summer travel that have left many people with less time to donate are all factors contributing to the shortage.
There are 57,000 open appointments that must be filled before the end of August across Canada, the agency said.
This report by The Canadian Press was first published Aug. 13, 2021.
Christopher Reynolds, The Canadian Press
Canada hasn’t needed to declare monkeypox an emergency, top doctor says. Here’s why – Global News
Canada has not needed to declare an emergency over the monkeypox virus the same way the United States and the World Health Organization have as mechanisms are already in place to tackle the outbreak, the country’s top doctor said Friday.
Dr. Theresa Tam’s comments came a week after the U.S. declared a public health emergency in response to the monkeypox outbreak, which followed the WHO declaring monkeypox a global health emergency last month.
“There’s a very different approach in terms of accessing authorities and funding in the United States compared to Canada,” said Tam during a virtual news conference.
“We have different approaches … with the provinces being able to declare crises, emergencies at their level,” she added.
Tam noted that when the COVID-19 pandemic first hit Canada over two years ago, there was no actual declaration at the federal level for a public health emergency under the Emergencies Act.
“For monkeypox, we’ve been already doing all the things that the U.S. is also doing — being able to mobilize vaccines, being able to mobilize therapeutics,” she said, adding that the local and provincial authorities have the flexibility to do what they need to respond.
“Health Canada regulatory authorities are there for emergency purposes as far as needed as well,” Tam said.
About 50% of monkeypox vaccine supply used, Canada passes 1,000 cases: Tam
In Canada, as of August 10, 1,059 monkeypox cases have been reported across the country, with Ontario leading the case count with 511 infections, followed by Quebec with 426.
To date, there have been 28 hospitalizations, including two ICU admissions, due to monkeypox, but no deaths in Canada.
Tam said there were some “early signs” that cases are slowing down in the country, but it’s “a little too soon to tell.”
The growing threat of monkeypox has raised alarm in countries, including Canada, not accustomed to seeing such a surge as much still remains unknown about the viral infectious disease.
‘Too soon to tell’ if monkeypox plateauing in Canada, but some early signs of slow down
Globally, more than 31,000 cases have been confirmed in 91 countries, according to the WHO. Tam said this represents a 19 per cent increase in global cases over one week.
On July 23, WHO’s chief declared monkeypox a public health emergency of international concern, citing the unprecedented rapid spread of the virus to many countries; the risk it poses to human health, and the potential for interference with international traffic.
Under the International Health Regulations (IHR), when a “public health emergency of international concern” is declared, international efforts are required to stop the spread of the virus. This could include sharing vaccines and treatments among countries and taking travel-related measures.
In Canada, the federal government has deployed to provinces and territories more than 99,000 doses of the Bavarian Nordic’s Imvamune or MVA-BN vaccine, normally used to treat smallpox.
More than 50,000 people have been vaccinated, as of August 11, said Tam.
U.S. health officials on Tuesday authorized a plan to stretch the nation’s limited supply of monkeypox vaccine by giving people just one-fifth the usual dose, citing research suggesting that the reduced amount is about as effective.
Tam said it was “an important approach to explore” and gather information to see if the same can be implemented in Canada.
“But for now, we are working together with the National Advisory Committee on Immunization for really pushing out the approach of one-dose first to reach as many people as possible in our most highly-affected populations,” she said.
Experts urge Canadian officials to take more action on monkeypox spread
Monkeypox is primarily transmitted through prolonged close contact with an infected person and the majority of cases reported in the current outbreak involve men who had intimate sexual contact with other men.
The current outbreak in Canada is largely from person-to person spread, said Tam, but the virus can also spread through direct contact with contaminated objects such clothing, sheets or other personal items.
Symptoms of monkeypox include a painful rash that could last between 14 and 28 days, which can be accompanied by fever, chills, headache, swollen lymph nodes, muscle pain, joint pain, back pain or exhaustion.
Monkeypox: Canada exploring fractional vaccine doses, but focused on 1st dose push
— with files from the Associated Press
© 2022 Global News, a division of Corus Entertainment Inc.
Coronavirus Update: Pregnant women who receive mRNA COVID-19 vaccines aren't more at risk of miscarriage, stillbirth, new study confirms – The Globe and Mail
Good evening. The coronavirus newsletter now publishes Mondays and Fridays.
- Pregnant women who received mRNA COVID-19 vaccines were not more likely to experience miscarriage, stillbirth or other severe health events compared to unvaccinated pregnant women, a new study says
- ‘It’s hard to explain how much we’ve seen and how much we’ve been through’: A growing number of health professionals have been harassed and abused by individuals promoting COVID-19 conspiracies online and in person – despite a federal law that makes it illegal
- The Canadian economy was losing between $2.6-billion and $5.2-billion a week as a result of the countrywide trucker convoy blockades, newly disclosed cabinet documents show
An increasing number of health agencies have changed how they’re reporting data on the coronavirus. A look at the current numbers in Canada for reported cases, deaths from COVID-19 and for hospitalizations can be found here.
COVID-19 updates from Canada and the world
- With pregnant women having a lower vaccination rate than the general population, a new study sheds light on the safety of mRNA COVID-19 vaccines when administered to expectant moms. Vaccinated pregnant women were not more likely to experience miscarriage, stillbirth or other severe health events compared with unvaccinated pregnant women, according to the study. “If you get sick with the infection, it actually has really adverse effects on pregnant people,” said Julie Bettinger, senior study author and a pediatrics professor at the University of British Columbia.
- Nurses and doctors say the spread of pandemic-related conspiracy theories and false information is increasingly turning people against the health care system, causing them to reject vaccines and exposing health professionals to a barrage of abuse.
- Ottawa produced an internal estimate of the GDP impact of countrywide blockades, projecting that they caused economic losses of 0.1 per cent to 0.2 per cent of GDP per week, newly disclosed cabinet documents show. The documents also included the revelation that the Prime Minister’s national security adviser, Jody Thomas, told the full cabinet on the evening of Feb. 13 that there was a potential for a breakthrough with the protesters who had blockaded downtown streets in Ottawa for weeks. Prime Minister Justin Trudeau and his cabinet invoked the Emergencies Act the next day.
- Moderna is announcing that it has agreed to purchase land in a biotechnology park near Montreal, to serve as the site of its biomanufacturing facility for its mRNA vaccines, including COVID-19 vaccines.
- The U.S.’s Centers for Disease Control and Prevention relaxed its COVID-19 guidelines yesterday – dropping the recommendation that Americans quarantine themselves if they come into close contact with an infected person.
- The European health regulator has started a rolling review of a variant-adapted COVID-19 vaccine from Pfizer and BioNTech – adding that officials plan to use bivalent shots in their autumn vaccination campaign, with most cases in the region now linked to the BA.5 variant.
- North Korea’s Kim Jong-un declared victory in the battle against COVID-19 yesterday, even though the country has never confirmed how many people caught COVID-19, apparently lacking testing supplies.
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- The pandemic has changed a lot about how we work, but it hasn’t changed when we are most productive, according to the results of a new survey. Daniel Pink, author of When: The Scientific Secrets of Perfect Timing, says that these patterns provide a strong argument for greater autonomy and flexibility in the workplace. While research has proven that workers are equally or more productive when they get to choose their work location, he believes there’s even more productivity to be gained by providing employees with greater control over when they work.
- Outdoors activities were among the many things that got more expensive and difficult to enjoy when the pandemic hit. Here’s a list of a few relatively low- and medium-cost outdoor activities to pursue, as the pandemic heads further into recovery.
- New Zealand welcomed the first cruise ship to the country since the coronavirus pandemic began, signalling a long-sought return to normalcy for the nation’s tourism industry.
- Manulife missed analyst profit expectations after a $1.6-billion drop in earnings owing to market turmoil and extended COVID-19 restrictions in Asia.
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John Ibbitson: Pierre Poilievre’s goal to block COVID-19 vaccine mandates doesn’t reconcile with public harm it would cause
Campbell Clark: The convoy wasn’t leaving town – but that’s not the Emergencies Act question
David Parkinson: The Great Resignation has arrived in Canada
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