Serum defensin levels in patients with systemic sclerosis

Research
Open Access
Published: 22 December 2020
Serum defensin levels in patients with systemic sclerosis
Tugce Emiroglu Gedik, Hamit Kucuk, Berna Goker, Seminur Haznedaroglu, Hatice Pasaoglu, Ozkan Varan, Mehmet Akif Ozturk, Ozge Tugce Pasaoglu & Abdurrahman Tufan
Advances in Rheumatology volume 60, Article number: 54 (2020) Cite this article

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Abstract
Background
Systemic sclerosis (SSc) is an autoimmune disease characterized by fibrosis of skin and lung as well as involvement of kidney, gastrointestinal system and heart. Aetiology and exact mechanism of disease is poorly understood. The association between antimicrobial peptides (AMPs) and other diseases such as idiopathic pulmonary fibrosis, diffuse panbronchiolitis, pulmoner alveolar proteinosis and psoriasis have been reported. A small number of studies have examined the role of AMPs on autoimmune diseases which has not been studied in scleroderma yet. We aimed to investigate AMP serum levels and their association with disease characteristics of SSc.

Methods
Forty-two patients (40 female, mean age 42 years) and 38 healthy subjects (32 female, mean age 38 years) were enrolled. For SSc patients, the following data were recorded: disease subset (limited/diffuse), autoantibodies (antinuclear, anti-centromere (ACA), and anti-SCL-70), blood tests, erythrocyte sedimentation rate (ESR), and C-reactive protein (CRP), modified Rodnan skin score, presence and history of digital ulcers, kidney, gastrointestinal disease and lung involvement assessed by computed tomography and pulmonary function tests. Association between serum AMPs and disease characteristics were analysed.

Results
Twenty-nine of the patients had diffuse (69%) and 13 of the patients had limited (31%) systemic sclerosis. Average disease duration was 5.5 years. Pulmonary involvement was detected in 20 patients (47.6%). Serum concentration of alpha defensin was higher than healthy subjects (563 ± 415 vs 377 ± 269 ng/mL, p = 0.02). However, no difference was observed for beta-1 and beta-2 defensins in SSc patients and healthy controls. In sub-group analysis patients with interstitial lung disease had higher levels of alpha defensin than those without lung involvement (684 ± 473 vs 430 ± 299 ng/ml, p = 0.04). There was also correlation between alfa defensin serum concentrations and CRP (r = 0.34).

Conclusions
Alpha defensin levels are increased in scleroderma patients and correlated with lung involvement indicating a role in the pathogenesis of disease.

Trial registration
This study is not a clinical trial study.

Introduction
Systemic sclerosis (SSc) is a chronic multisystemic autoimmune disease manifested by diffuse fibrosis of the skin and internal organs [1]. Although the pathogenesis of the disease is largely unknown, three major pathologic changes take part in its evolution; fibrosis, vasculopathy and inflammation. SSc is largely considered as an autoimmune disease with activation of both innate and adaptive components of immune system [2].

One of the critical components of innate immune system is antimicrobial peptides (AMPs). There are hundreds of structurally different peptides with antimicrobial properties which are found in all eukaryotic organisms. AMPs are particularly synthesized in mucosal epithelial cells and neutrophils that are constantly in contact with microorganisms in the body. In humans, there are three main family of AMPs; defensins, cathelicidin (LL37) and histatin [3]. Alpha-defensins (HNP1) are primarily expressed in neutrophils, while beta-defensins and LL37 are constitutively synthesized and secreted from epithelial surfaces, therefore called as epithelial AMPs [4]. AMPs have direct microbicidal effects and play critical role in cleaning intracellular microorganisms and fighting against cancer cells [5, 6]. Besides having direct antimicrobial effects, AMPs can incite inflammation by activating immune effector cells and chemotaxis of neutrophils [4]. Epithelial AMPs may stimulate production of pro-inflammatory cytokines such as IL-17, IL-22, and TNF alpha [7]. Another important role of AMPs involves the maintenance of the host microbiota besides their antimicrobial functions.

To date, limited number of studies have investigated the relationship between antimicrobial peptides and autoimmune/inflammatory diseases. In patients with systemic lupus erythematosus (SLE), alpha defensin and beta-2 defensin levels were found elevated and related with disease activity [8, 9]. There is not much literature on the potential role of AMPs in SjS; however, some studies suggest that cathelicidin and defensins may have a role in the pathophysiology of the disease [10]. The role of AMPs in pulmonary diseases have been shown in idiopathic pulmonary fibrosis, diffuse panbronchiolitis and pulmonary alveolar proteinosis. The role of AMPs are scarcely studied in scleroderma and there is downregulation of LL-37 in diffuse SSc patients [11] and tissue beta defensin of localized scleroderma after UVA-1 treatment [12]. Herein, we aimed to investigate alpha and beta defensin serum concentrations in patients with SSc and their association with disease characteristics.

Materials and methods
The study included consecutive SSc patients over 18 years of age who met the diagnostic criteria for SSc [13]. Patients with other autoimmune disease or overlap syndromes, infections, immunodeficiency, chronic liver and kidney dysfunction were excluded from the study. Patients receiving corticosteroids and immuno-suppressive drugs were excluded from the study. Control group consisted age- and sex-matched healthy subjects. Written consent was obtained and included in the study. All participants were informed about the objectives of the study and gave their signed consent for inclusion. The study was approved by the local ethics committee (Ethics committee approval ID: 28.09.2015/3).

Demographic and clinical features of SSc patients were obtained by patient interviews and hospital file records. Detailed physical examination was performed for each patient and skin fibrosis was assessed by an experienced physician. Laboratory parameters, acute phase reactants and serologic tests including anti-nuclear antibodies, anti-scl-70 and anti-centromere antibodies were retrieved from computer based hospital records. Pulmonary function tests, high resolution thorax computed tomography (HRCT) and echocardiographic findings were recorded. Interstitial lung disease was defined as interstitial fibrosis, reticulation or alveolitis on high-resolution computer tomography. Pulmonary hypertension was defined as mean pulmonary artery pressure ≥ 25 mm/Hg. Gastrointestinal involvement was evaluated in all subjects with oesophageal manometry and considered positive if there was consistent findings. Finally, SSc patients were categorized by LeRoy's classification system as diffuse and limited SSc [14].

Blood samples were taken from antecubital vein after overnight fasting at morning hours and immediately centrifuged. Sera was separated and stored at − 80 °C until they studied. Serum alpha defensin (HNP1), beta-defensin 1 and 2 levels were determined by using commercial enzyme-linked immunosorbent assay (ELISA) kits (Assay Biotech, USA).

Statistical Package for the Social Sciences software v16.0 (SPSS Inc., Chicago, IL) was used for statistical analysis. Categorical data were expressed as numbers and percentages. Chi square test was used to compare categorical variables. Normality distribution of continuous variables were evaluated with using Kolmogorov-Smirnov test. Continuous variables are expressed as median [Interquartile range (IQR)] values since they did not show normal distribution. Continuous variables of groups were compared with Mann-Whitney U and Kruskal-Wallis tests. Spearman Rho was used for correlation analyzes. Differences between groups were considered significant at the 5% level (p < 0.05).

Results
A total of 80 individuals, 42 SSc patients and 38 healthy control subjects were included in the study. Forty patients were female and mean age of patients was 42 ± 11 years. Mean age of control group was 38 ± 11 years and 32 were female.

Twenty-nine (69%) patients had diffuse and 13 patients (31%) had limited systemic sclerosis. The mean disease duration was 5.5 ± 4.8 years. Organ involvements of the patients are presented in Table 1. Pulmonary involvement on HRCT was evident in 20 (47.6%) patients.

Table 1 Clinical manifestations of systemic sclerosis patients
Full size table
Serum alpha defensin levels of SSc patients were significantly higher than control subjects (563 ± 415 vs 377 ± 269 ng/mL,p = 0.02). However no differences were observed in serum concentrations of epithelial defensins ─ beta-1 and beta-2 between SSc patients with healthy subjects (beta-1 defensin 235 ± 178 vs 185 ± 24 pg/mL, p = 0.08 and beta-2 defensin 253 ± 453 vs 152 ± 101 pg/ml, p = 0.1). There were no statistically significant differences in alpha, beta-1 and beta-2 defensin levels between diffuse and limited forms of SSc (p = 0.08, p = 0.56, p = 0.57; respectively). In sub-group analysis, with regard to organ involvements, patients with interstitial lung disease had remarkably higher levels of alpha defensins than those without lung involvement (684 ± 473 vs 430 ± 299 ng/mL, p = 0.04, Table 2). However any association was found between organ manifestations and serum concentrations of epithelial defensins ─ beta-1 and beta-2 in patients with SSc. There was a correlation between CRP (r = 0.345, p = 0.03), modified Rodnan Score (r = 0.296 p = 0.07) and % forced vital capacity FVC (r = 0.306 p = 0.07).

Table 2 Alpha defensin levels according to clinical manifestations of systemic sclerosis
Full size table
Discussion
In this cross-sectional study, we investigated serum levels of the one of the major antimicrobial peptide family, defensins. We found that serum concentrations of alpha defensins are increased in SSc patients. Moreover, elevation in serum alpha defensin (HNP-α) was more remarkable in SSc patients with pulmonary involvement.

AMPs are part of the innate immunity with capability of activating adaptive immune system [15]. The level of AMP expression varies among individuals, and it has been suggested that this variation is due to genetic differences in the genes encoding defensins. These peptides are also known as danger signals or" alarmins" playing important roles in inflammation and immunity [16]. AMPs can be released into the extracellular area following granulocyte activation as a consequence of degranulation, cell death, leakage, and lysis during inflammation [17]. Recent studies show that the abnormal production of AMPs produced by neutrophils or epithelial cells promotes inflammation by supporting the autoimmune response. However, there are not enough studies related to the significance of abnormal levels of AMPs in SSc.

AMP levels have been studied in some inflammatory diseases such as rheumatoid arthritis, SLE, inflammatory bowel disease, psoriasis, atopic dermatitis and familial Mediterranean fever (FMF). These studies showed that AMPs expression were irregular in diseases such as systemic lupus erythematosus (SLE), psoriasis, rheumatoid arthritis (RA), type 1 diabetes (T1D), Sjögren's disease (SjS) and multiple sclerosis (MS) [10]. Hiroyuki Tamiya et al. reported significantly higher defensin and cathelicidin levels in active SLE patients [18]. Tufan et al. found similar results in FMF patients that increased alpha- defensin and cathelicidin levels with no significant difference for beta-2-defensin [19]. In another study on psoriasis patients, use of serum beta-2-defensin levels are suggested as a marker reflecting psoriasis disease activity [20]. Cathelicidin and human beta-defensins 2 and 3 (hBD2/3) have been shown to be highly expressed in the psoriatic skin of patients [21, 22]. The expression of human neutrophil peptides (HNPs) 1–3 was significantly increased in the synovial cavity of patients with RA and related with joint erosion [23].

Previous studies have demonstrated increased AMP levels in inflammatory lung diseases. It was shown that HNP levels were 50 times higher in bronchoalveolar lavage samples of ARDS patients [24]. In a study by Noriho Sakamoto et al., AMP levels were studied in patients with interstitial pneumonia (IP). Their study included 21 acute attack IP, 44 stable IP, 9 infected IP patients and 23 healthy controls. The level of alpha-defensin was found to be significantly increased in patients with acute exacerbation. Beta- defensin-2 was found to be higher in patients with stable IP than in healthy controls [25]. Mukae et al. found that serum alpha-defensin levels were higher in patients with idiopatic pulmonary fibrosis (IPF) compared to control group. But no difference was found between bronchoalveolar lavage levels [26]. In another study, Mukae et al. compared defensin levels of IPF, cryptogenic organized pneumonia (COP), pulmonary alveolar proteinosis PAP), sarcoidosis, and idiopathic nonspecific interstitial pneumonia (NSIP) patients and defensin levels were significantly higher than the control group. There was a significant difference between the diseases as well. Beta defensin-1 levels were significantly higher in IPF, COP, NSIP and sarcoidosis patients compared to the control group. Beta-2 defensin levels were significantly higher in sarcoidosis and IPF patients compared to the control group [27].

Defensin family AMPs have not been thoroughly studied in patients with SSc. In our study, we aimed to determine serum levels of main defensins and their association with disease characteristics. We found significantly increased serum alpha defensin levels particularly in those with interstitial lung involvement. Alpha-defensin is mainly released from neutrophils and activate neutrophils with a positive feedback loop and they might contribute lung inflammation observed in SSc and other pathologies. Supporting this hypothesis, serum alpha defensin levels were correlated with acute phase reactants. Interestingly, serum alpha defensin levels were also correlated with skin fibrosis suggesting a role in the pathogenesis of fibrosis. An in vitro study investigated effects of alpha defensin in lung tissue that it enhanced expression of IL-8 in epithelial cells as well as transforming growth factor-beta and vascular endothelial growth factor expressions in lung fibroblasts [28]. Another study confirmed that alpha-defensin contribute neutrophilic lung inflammation via inducing synthesis of a strong neutrophil chemoattractant, IL-8, in airway epithelial cells [29].

In a previous study, Kuzumi et al. reported decreased serum beta-2 defensin levels in SSc patients which was highly dependent on duration of disease [30]. In that study they found significant associations between beta-2 defensin and telangiectasia, pitting scars and digital ulcers suggesting its contribution to pathogenesis of vasculopathy observed in SSc. However they did not find an association with lung involvement [30]. In our study, we did not find a difference for beta-1 and beta-2 defensin levels in SSc patients compared to healthy subjects. Discrepancy between results of studies can be explained by differences in clinical manifestations of patients and duration of disease.

We have several limitations in our study. First, we did not assess serum cytokine levels in SSc patients which might demonstrate association between defensins and inflammatory and fibrotic mediators. Second, number of SSc patients are relatively small and inclusion of more patients might reveal better results.

Conclusions
In conclusion, serum alpha defensin concentrations are increased in SSc patients and associated with lung involvement and skin fibrosis. Further studies involving more patients and detailed molecular tests are needed to determine whether these molecules contribute to the course and pathogenesis of systemic sclerosis.

Availability of data and materials
The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Abbreviations
ANA:
Anti-nucleer antibody

AMP:
Antimicrobial peptides

DLCO:
Diffusing Capacity of Lung for Carbon Monoxide test

ECG:
Elektrocardiografi

Echo:
Echocardiografi

FEV-1:
Functional Expiratory Volume

FVC:
Force vital capacity

hBD − 1.2.3:
Human Beta defensins 1.2.3

HRCT:
High resolution computerized tomography

HNP:
Human Neutrophil Peptides

Rf:
Raynaud Fenomeni

PAH:
Pulmoner Arteryel Hypertension

RFT:
Respiratory function test

SSk:
Sistemik Skleroz

SP-D:
Surfaktan protein

COP:
Cryptogenic organized pneumonia

PAP:
Pulmonary alveolar proteinosis

NSIP:
Idiopathic nonspecific interstitial pneumonia

AMP:
Antimicrobial peptides

ARDS:
Acute respiratuar distress syndrome

FMF:
Familial Mediterranean fever

IPF:
Idiopatic pulmonary fibrosis

ELISA:
Enzyme-linked immunosorbent assay

RNP:
Ribonucleoprotein

IQR:
Interquartile range

ACA:
Anti-centromere

ESR:
Erythrocyte sedimentation rate

CRP:
C-reactive protein

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Criticism of lockdowns

Medical Prof Explains Devastating Effects Of Lockdown For A Virus With A '99.95%' Survival Rate

HAFJanuary 3, 2021

https://humansarefree.com/2021/01/medical-prof-explains-devastating-effects-of-lockdown-for-a-virus-with-a-99-95-survival-rate.html


by Arjun Walia

It's quite clear to see for anybody who is doing deep research into the COVID pandemic that there is a big split within the scientific/ medical community as to whether or not the measures being taken by governments around the world, like lockdowns, masking and social distancing are appropriate, effective and necessary.

If watching mainstream media and only obtaining information via the television screen, radio and newspaper is ones only exposure to news regarding the pandemic, this wouldn't seem to be the case, and it would seem that these measures are indeed necessary and appropriate because it seems to be the dominant viewpoint that's constantly presented and beamed out to the masses.

It's quite a concern to many that doctors and scientists who oppose the views and perception being given to us by mainstream media about the pandemic are largely ignored and censored.

Somebody like Dr. Anthony Fauci, for example, can receive instant virality yet thousands of scientists and experts in the field who disagree seem to be ignored, censored and never really given the light of day to share their research, data, and opinions.

The truth is, lockdown measures may not only be unnecessary and useless for combating COVID, but they are also having other detrimental consequences that could be worse than the virus itself.

This was recently expressed by Dr. Jay Bhattacharya, MD, PhD, from the Stanford University School of Medicine in an article written for The Hill titled "Facts, not fear, will stop the pandemic."

In that article he expresses that the case fatality rate from the virus has dropped sharply since March, and that it's now 99.95 percent for people under the age of 70 and 95 percent for people over the age of 70.

He also recently expressed this fact on a JAMA (The Journal of the American Medical Association) Network conversation alongside Mark Lipsitch, DPhil and Dr. Howard Bauchner, who interviews leading researchers and thinkers in health care about their JAMA articles.

Bhattacharya cited this study published in the Bulletin of the World Health Organization, along with approximately 50 others as expressed in the video interview.

In the article he wrote for The Hill, he points out a number of facts regarding the implications of lockdown measures.

The media have paid scant attention to the enormous medical and psychological harms from the lockdowns in use to slow the pandemic. Despite the enormous collateral damage lockdowns have caused, England, France, Germany, Spain and other European countries are all intensifying their lockdowns once again.

By lockdowns, we mean the all-too-familiar shuttered schools and universities, closed playgrounds and parks, silent churches and bankrupt stores and businesses that have become emblematic of American civic life these past months.

The relative dearth of reporting on the harms caused by lockdowns is odd, since lives lost from lockdown are no less important than lives lost from COVID infection. But they've received much less media attention.

The harms from lockdown have been catastrophic. Consider the psychological harm. Reader, since you're reading this in lockdown, you can undoubtedly relate to the isolation and loneliness that these policies can cause by shutting down typical channels for social interaction.

In June, the Centers for Disease Control and Prevention (CDC) estimated that one in four young adults had seriously considered suicide. Opioid and other drug related deaths are on a sharp and unsurprising upswing.

The burden of these policies falls disproportionately on some of the most vulnerable. For example, isolation led to a 20 percent increase in dementia-related deaths among our elderly population. Moreover, retrospective analysis of the lockdown in the United States shows that patients skipped cancer screenings, childhood immunizations, diabetes management visits and even treatment for heart attacks.

Internationally, the lockdowns have placed 130 million people on the brink of starvation, 80 million children at risk for diphtheria, measles and polio, and 1.8 million patients at risk of death from tuberculosis.

The lockdowns in developed countries have devastated the poor in poor countries. The World Economic Forum estimates that the lockdowns will cause an additional 150 million people to fall into extreme poverty, 125 times as many people as have died from COVID.

Stanford Professor Of Medicine: COVID-19 Has A 99.95% Survival Rate For People Under 70

Criticism of lockdowns has been a common theme. Early on during the first wave of the pandemic, a report published in the British Medical Journal (BMJ)  titled Covid-19: "Staggering number" of extra deaths in community is not explained by covid-19″  has suggested that quarantine measures in the United Kingdom as a result of the new coronavirus may have already killed more UK seniors than the coronavirus has during the months of April and May.

A response by Professor David Paton, Professor of Economics at the University of Nottingham and Professor Ellen Townsend, a Professor of Psychology at the University of Nottingham School of Medicine, to an article  published in the the BMJ in November titled "Screening the healthy population for covid-19 is of unknown value, but is being introduced worldwide" states,

Taken together, the data are clear both that national lockdowns are not a necessary condition for Covid-19 infections to decrease and that the Prime Minister was incorrect to suggest to MPs that infections were increasing rapidly in England prior to lockdown and that without national measures, the NHS would be overwhelmed…

Lockdowns have never previously been used in response to a pandemic. They have significant and serious consequences for health (including mental health), livelihoods and the economy.

Around 21,000 excess deaths during the first UK lockdown were not Covid-19 deaths. These are people who would have lived had there not been a lockdown.

It is well established that the first lockdown had an enormously negative effect on mental health in young people as compared to adults.

The more we lockdown, the more we risk the mental health of young people, the greater the likelihood the economy will be destroyed, the greater the ultimate impact on our future health and mental health.

Sadly, we know that global economic recession is associated with increased poor mental health and suicide rates.

According to a recent study published in Pediatrics, lockdown and social distancing measures are strongly correlated with an increase in suicidal thoughts, attempts and behaviour.

According to Dr. John Lee, a former Professor of Pathology and NHS consultant pathologist,

Lockdowns cannot eradicate the disease or protect the public…They lead to only economic meltdown, social despair and direct harms to health from other causes…Scientifically, medically and morally lockdowns have no justification in dealing with Covid.

These facts and many others are what inspired Bhattacharya, along with Dr. Martin Kulldorff, professor of medicine at Harvard University, a biostatistician, and epidemiologist, and Dr. Sunetra Gupta, professor at Oxford University, an epidemiologist with expertise in immunology to create The Great Barrington Declaration.

The declaration strongly opposes lockdown measures that are being and have been put in place by various governments around the globe. The declaration has an impressive list of co-signers from renowned doctors and professors in the field from around the world, and now has nearly 50,000 signatures from doctors and scientists. The declaration also has approximately 660,000 signatures from concerned citizens.

Scrolling through the twitter feed of The Great Barrington Declaration, I came across a post from the American Institute For Economic Research (AIER) titled "Lockdowns Do Not Control The Coronavirus: The Evidence."

In the article they argue that, "In a saner world, the burden of proof really should belong to the lockdowners, since it is they who overthrew 100 years of public-health wisdom and replaced it with an untested, top-down imposition on freedom and human rights. They never accepted that burden. They took it as axiomatic that a virus could be intimidated and frightened by credentials, edicts, speeches, and masked gendarmes."

According to the AIER,

The pro-lockdown evidence is shockingly thin, and based largely on comparing real-world outcomes against dire computer-generated forecasts derived from empirically untested models, and then merely positing that stringencies and "nonpharmaceutical interventions" account for the difference between the fictionalized vs. the real outcome. The anti-lockdown studies, on the other hand, are evidence-based, robust, and thorough, grappling with the data we have (with all its flaws) and looking at the results in light of controls on the population.

AIER gathered data that was put together by engineer Ivor Cummins Ivor Cummins but has also added its own in the summary they posted, which you can see below.

The studies are focused only on lockdown measures and they "do not get into the myriad of associated issues that have vexed the world such as mask mandates, PCR-testing issues, death misclassification problem, or any particular issues associated with travel restrictions, restaurant closures, and hundreds of other particulars about which whole libraries will be written in the future."

You can access those studies posted by the AIER here.

Other concerns with regards to lockdowns are the fact that they are based on "positive" results from a PCR test. Just because a person, especially an asymptomatic person, tests positive does not mean they have COVID. We seem to be forgetting this.

For example, 22 researchers have put out a paper explaining why, according to them, it's quite clear that the PCR test is not effective in identifying COVID-19 cases. As a result we may be seeing a significant amount of false positives.

The Deputy Medical Officer of Ontario, Canada, Dr. Barbara Yaffe recently stated that COVID-19 testing may yield at least 50 percent false positives. This means that people who test positive for COVID may not actually have it.

In July, professor Carl Heneghan, director for the centre of evidence-based medicine at Oxford University and outspoken critic of the current UK response to the pandemic, wrote a piece titled "How many Covid diagnoses are false positives?" He has argued that the proportion of positive tests that are false in the UK could also be as high as 50%.

There are many examples, the list goes on and on and you can read more about that specifically here.

Although deaths are currently running at normal levels, fear is being driven by inflation of Covid "ases" caused by inappropriate use of the Polymerase Chain Reaction (PCR) test. This test is hypersensitive and highly susceptible to contamination, particularly when not processed with utmost rigour by properly trained staff. Case inflation also occurs from use of excessive number number of rounds of amplification cycles (termed CT) which amplifies non-infectious viral fragments and cross-reacting nucleotides from non-Covid coronaviruses/other respiratory viruses. These become mis-labelled as Covid.

Even Dr. Fauci confirms that a positive result using CT above 34 is invalid. An obvious improvement is to immediately halt any use of CTs above 34 and ensure that or CTs between 25 and 34, two consecutive positive results are required before confirming a case as Covid positive. – Eshani M King, Evidence Based Research in Immunology and Health, Tewkesbury, Gloucestershire, UK. (Source, BMJ)

Many concerns have also been raised about the death count, with various public health authorities admitting to counting deaths as COVID when they're not actually a result of COVID. For example, Ontario (Canada) public health clearly states that deaths will be marked as COVID deaths whether or not it's clear if COVID was the cause or contributed to the death. This means that those who did not die as a result of COVID are included in the death count. You can read more about that and see many more examples, here.

The ease to which people could be terrorised into surrendering basic freedoms which are fundamental to our existence..came as a shock to me…History will look back on measures – as a monument of collective hysteria & government folly." – Jonathan Sumption, former British supreme court justice. (source)

The Takeaway

Implementation of the current draconian measures that so extremely restrict fundamental rights can only be justified if there is reason to fear that a truly, exceptionally dangerous virus is threatening us. Do any scientifically sound data exist to support this contention for COVID-19? I assert that the answer is simply, no. –Dr. Sucharit Bhakdi, a specialist in microbiology and one of the most cited research scientists in German history.

Why is there so much suppression of science and scientists who oppose the narrative and information being put out by the World Health Organization?

Over the last few months, I have seen academic articles and op-eds by professors retracted or labeled "fake news" by social media platforms. Often, no explanation is provided. I am concerned about this heavy-handedness and, at times, outright censorship. – Vinay Prasad, MD, MPH (source)

Why is there a digital fact-checker going around the internet censoring information?

Should people not have the right to examine information, publications and evidence transparently, openly and determine for themselves what they wish to believe?

Why are government health authorities not consulting with independent scientific organizations to determine the right course of action during this pandemic?

Why do tens of thousands of doctors and scientists oppose the measures being taken by our governments?

Why have other treatments been ridiculed and not even considered?

Why has a vaccine been made out to be the only solution here, and why did the World Health Organization recently change their definition of herd immunity?

Do we really want to give these entities so much power that they can basically do whatever they choose against the will of so many people? Do governments even represent the will of the people and have our best interests at heart or is something else going on here? Why do we as a society fail to have proper discussions about controversial topics? Why are controversial stances that go against the grain always labelled as a "conspiracy theory" and ridiculed by mainstream media no matter how strong the evidence is behind them?


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Medicine by Alexandros G. Sfakianakis,Anapafseos 5 Agios Nikolaos 72100 Crete Greece,00302841026182,00306932607174,alsfakia@gmail.com,
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Medicine and Biomedical Sciences

Goodbye 2020! Elmahdi A Elkhammas, Salem Arifi Beshyah Ibnosina Journal of Medicine and Biomedical Sciences 2020 12(4):235-236

Characterizing lung cancer in Libya: A stepping stone toward a better lung cancer care in the country Wanis H Ibrahim, Tasleem Raza Ibnosina Journal of Medicine and Biomedical Sciences 2020 12(4):237-239

Ramadan fasting in health and disease (2019): A narrative review Khawla F Ali, Sara A Abdulla, Amal Badi, Khadija Hafidh, Salem Arifi Beshyah Ibnosina Journal of Medicine and Biomedical Sciences 2020 12(4):240-257 Introduction: Literature on the health aspects of Ramadan fasting (RF) is widespread in many journals, making it less readily available to those interested in the subject. Materials and Methods: This is a narrative, nonsystematic review of international literature from two major online databases (viz., Scopus and PubMed) in 1 year (2019). The search term “RF” was used, and relevant literature was narrated in a concise thematic account excluding diabetes. Results: The publications spanned the fundamental, clinical, ethical, professional, cultural, and advocacy facets of the subject. The publications crossed the conventional disciplinary lines and geographical locations and appeared in journals with different access systems. The content is presented under relevant themes depending on the available literature. Basic coverage included changes in physiology, nutrition, and metabolism during Ramadan. Clinical aspects such as the impact of RF on kidney function, pregnancy outcome, fetal life, structure and function of eyes, and athletes' well-being received comparatively prominent coverage by researchers in 2019. Gut, liver, skin, skeleton, and blood were also covered. Other workers focused on documenting the perception, attitudes, and practices of both patients and health-care professionals during Ramadan. Conclusions: The health aspects of RF received sustained academic interest with a wide spectrum in 2019. We provided a scoping overview to help researchers and clinicians catch up quickly with the state-of-the-art today.

Mental health of health-care workers during the COVID-19 pandemic Walaa Mogassabi, Waqar Mogassabi, Maram Saliba, Rana M Emam, Wanis H Ibrahim Ibnosina Journal of Medicine and Biomedical Sciences 2020 12(4):258-263 Besides its effects on physical health, the coronavirus disease 2019 (COVID-19) pandemic has resulted in adverse consequences on mental health of health-care workers. Several factors such as safety concerns and fear of infecting self or family members, social isolation measures, strict infection control procedures, lack of protective measures, exhaustion due to increased duration of working, and seeing patients die or colleagues infected can contribute to the development of mental health problems in health-care workers during the current COVID-19 pandemic. Some health-care staff including nurses, advanced practice providers, frontline health-care workers, and health-care workers who have children are more vulnerable to these mental health problems. Prevention of infection and staff burnout in health-care workers, provision of a timely mental health care, and social support are among the most important measures to provide a mental health care for health-care workers during the current COVID-19 pandemic.

An analysis of gut dysbiosis in obesity, diabetes, and chronic gut conditions Ahmed Haleem, Sama Anvari, Aisha Nazli, Mohamed Sager, Mahmood Akhtar Ibnosina Journal of Medicine and Biomedical Sciences 2020 12(4):264-271 Introduction: Gut dysbiosis is an imbalance in the microbial communities of the intestine and has been associated with numerous chronic diseases. Objectives: We aimed to compare gut dysbiosis within and across various disease states (Crohn's disease [CD], colorectal cancer [CRC], irritable bowel syndrome [IBS], and type 2 diabetes mellitus [T2DM], and obesity). Materials and Methods: Assessing comparative studies which examined levels of bacterial phyla in cases and controls. PubMed and Web of Science were searched to identify relevant studies, in which human fecal samples were used to analyze microbial flora. Results: Twenty-one studies were included, which met inclusion and exclusion criteria. Three studies were included assessing IBS, which found a decrease in Bacteroidetes in the IBS population, but inconsistent findings for other phyla. Six studies were included assessing obesity, and no consistent patterns emerged. Five studies were included examining T2DM, which found a consistent decrease in the Firmicutes/Bacteroidetes ratio in cases as compared to controls. No patterns were found for other phyla. Three studies were included examining CD, and five examining CRC. Conclusions: No consistent patterns were found for either of these diseases. While some patterns were found in bacterial phyla distribution, there were few commonalities, even in same-system disorders. However, uncovering underlying dysbiosis patterns shows great promise in furthering the understanding of disease pathogenesis and the potential for new therapeutic and diagnostic interventions. Further systematic reviews and well-controlled studies are warranted.

Trends, and tumor characteristics of lung cancer and malignant pleural mesothelioma in the East of Libya Wail A Eldukali, Khaled Elmahdi Omran, Raouf Azzuz Ibnosina Journal of Medicine and Biomedical Sciences 2020 12(4):272-279 Background: Lung cancer is the most common cancer worldwide and the leading cancer killer. Lung cancer is classified histologically into two types; small-cell lung cancer and nonsmall-cell lung cancer (NSCLC) (squamous cell carcinoma, adenocarcinoma (AC), large cell carcinoma [LCC]). Malignant pleural mesothelioma is a rare thoracic tumor. We aimed to provide comprehensive epidemiological data about lung cancer in the eastern part of Libya. Patients and Methods: A retrospective medical records review of lung cancer patients attending the oncology department of Benghazi Medical Center from January 1, 2006 to December 31, 2015. Results: There were 684 lung cancer cases out of 7725 total registered cancer cases (8.85%), 627 were male (91.7%, median age 63.5), and 57 females (8.3%, median age 64). NSCLC was the dominant histology 78.5%, SCLC 11%, and malignant mesothelioma 2.5%. NSCLC subtypes were AC (35.1%), squamous carcinoma (25.7%), LCC (4.6%), and not otherwise specified (12.6%). Only 30.6% of cases were diagnosed in Libya, the most commonly used diagnostic modalities were bronchoscopic biopsy 46.6%, and computed tomography guided biopsy 17.4%. Only 18 cases were tested for epidermal growth factor receptor sensitizing mutations and anaplastic lymphoma kinase rearrangement fusion. Stage IV was the most common initial stage for NSCLC 60%, malignant mesothelioma 47.1%, and 74.7% of SCLC presented with extensive disease. Only 42.9% of males and 5.3% of female lung cancer patients were smokers. Conclusions: Lung cancer is a major health burden in Libya, and it is increasing in incidence; this epidemiological study tries to put this problem into public health and clinical perspective.

Impact of COVID-19 on educational and academic activities of health-care professionals: An international survey of doctors, dentists and nurses. Hussain Alsaffar, Haider Al Saffar, Khadija Ali, Fahad Aljaser, Amar Mahdi, Manar Muhammad, Salwa Alaidarous, Najwa Rbiai, Iyad Ahmed, Foued Abdelaziz, Asma Deeb Ibnosina Journal of Medicine and Biomedical Sciences 2020 12(4):280-287 Introduction: The COVID-19 pandemic has affected the whole world in different levels from numerous aspects. This deadly, highly contagious viral infection has led to lockdown in many cities across the world; significantly disrupting previously planned educational activities. Objectives: We aim to evaluate the impact of the COVID-19 pandemic on the educational and academic activities of the health care professionals practicing in different countries. Subjects and Methods: A cross-sectional survey was conducted using a link to an online questionnaire which was sent to doctors, dentists and nurses working in several countries using WhatsApp medical groups. The questionnaire consisted of eight questions related to the impact of COVID-19 on educational and academic activities of the health care professionals (HCPs). Results: 898 responses received from doctors (66.5%), nurses (21%) and dentist (12.5%), working in 36 countries. 66.6% of respondents think their academic activities are less than what it was before the pandemic. However, 63% of participants have attended more webinars and 58% have completed more on-line courses and e-learning sessions during the pandemic. Conclusions: COVID-19 pandemic negatively impacted the academic activities of HCPs. However, COVID-19 health crisis created an opportunity for enriching the educational activities through e-learning, online courses, and webinars. This experience should be in the future, with more online material available.

Predictors of dental general anesthesia receipt among children attending a tertiary hospital in Saudi Arabia Mostafa A Abolfotouh, Ghaida A Alhumaidan, Bashaer Y Almalki, Alanoud H Alhasson, Ibraheem Bushnak, Abdallah Adlan Ibnosina Journal of Medicine and Biomedical Sciences 2020 12(4):288-294 Aim: Children are normally treated in a dental chair, despite that some may have their treatment done under dental general anesthesia (DGA). Factors affecting the decision on DGA include the quality and quantity of treatment needed and child's age and cooperation. This study aimed to estimate the prevalence of DGA among children with dental caries and to identify the associated factors in a tertiary care setting in Saudi Arabia. Methods: A cross-sectional study of 400 children with dental caries was conducted. Data were collected from the patients' records including demographic, behavioral, and clinical information, diagnosis using caries indexes (Decayed, Missing, Filled Teeth/decayed filled teeth [dft]), and number of DGA and its indications. Logistic regression analysis was applied to identify the predictors of DGA, and significance was considered at P ≤ 0.05. Results: The study included 400 children; 55% of them were below the age of 6 years, with a mean age of 6.4 ± 2.3 years. About one-half of children were males (51.7%) and unhealthy (48.2%). The majority were of negative behavior (70.7%) and noncomplaint to dental appointments (70.3%). More than three-fourth of children (78.5%) experienced one or more DGA. GA use was significantly associated with gender (χ2 = 4.30, P < 0.04), age (t = 12.37, P < 0.0001), health status (χ2 = 16.02, P < 0.0001), dft index (z = 11.44, P < 0.0001), child behavior (χ2 = 48.54, P < 0.0001), age at the first dental visit (t = 11.73, P < 0.0001), number of dental treatment visits (z = 11.14, P < 0.0001) and dental preventive visits (z = 7.21, P < 0.0001) before the index dental visit, and compliance with dental appointments (χ2 = 39.50, P < 0.001). However, after adjusting for confounders, using the logistic regression analysis, DGA use was predicted by unhealthy children (odds ratio [OR] = 27.35, P = 0.002), those with a negative behavior (OR = 18.28, P = 0.003), and those with higher dft index (OR = 1.68, P < 0.001). Conclusions: Noncooperation, general health status, and dental caries level (dft) were the main factors for the decision of DGA. High caries-risk children must be the target for behavioral management to minimize their need for treatment under DGA. Post-DGA appointment to guide the child back to normal dental care is recommended.

Family relations of living-related kidney donors in Tripoli, Libya Jamila Salem Elamouri, Nada Bulgasem Fawaris Ibnosina Journal of Medicine and Biomedical Sciences 2020 12(4):295-299 Introduction: Despite efforts to increase community awareness of kidney donation and transplantation, there remains a huge gap between the number of kidneys needed and those available. Objectives: We aimed to document the types of relationship between donors and recipients of kidney transplants in a previously unexamined community. Patients and Methods: This was a descriptive retrospective study of 454 living-related kidney transplant patients registered during 2019 in the posttransplant clinic at the National Centre for Organ Transplantation, Tripoli, Libya. Demographic data and the type of relationship between recipients and donors were studied. Results: There was a male donor predominance (67.4%), with a male-to-female ratio of 2: 1. The mean age of the donors was 34.2 ± 10.27 years. The sibling constituted the majority (62.2%) of donors, with brother predominance. They were followed by off-spring donors (17.6%), with a predominance of sons and parents (12.4%), with mothers acting as donors more than fathers. Donation from spouses was relatively infrequent (3.5%). Conclusions: The study revealed that brothers are the most common donor and all donors more commonly donate to male recipients, except mothers who donate more commonly to female recipients. This may be reflective of the sociocultural factors. More social awareness is needed regarding organ donation, especially among females, to increase their contribution in donation.

Predisposing factors and health-care utilization in liver transplant recipients with takotsubo cardiomyopathy: A national analysis Kishan Patel, Salman K Bhatti, Sylvester M Black, Kyle Porter, James Hanje, Khalid Mumtaz Ibnosina Journal of Medicine and Biomedical Sciences 2020 12(4):300-306 Aims and Objectives: Takotsubo cardiomyopathy (TCMP) is an acquired cardiomyopathy associated with physical, emotional, and surgical stress. Current literature on TCMP in liver transplant recipients (LTRs) is limited to case reports and case series. Methods: The Nationwide Readmission Database was utilized to identify all adults with an index admission for LT between 2010 and 2014 who developed TCMP. The prevalence of TCMP at the LT admission or readmission within the calendar year was examined. Predictors of development and health-care utilization of patients with and without TCMP in LTR were compared. Multivariable regression analysis was performed. Results: The prevalence of TCMP in LTRs was found to be 0.5% (141/28,067). Most of these patients developed early TCMP on the index admission for LT (n = 115; 82%). Older (57.5 ± 1.3 vs. 55.1 ± 0.3 years, P < 0.001) females (adjusted odds ratio [aOR]: 2.27; confidence interval [CI]: 1.20–4.27; P = 0.01) with ≥4 Elixhauser comorbidity (aOR: 2.36; CI: 1.15–4.83; P = 0.02) were predisposed to develop TCMP in LTRs. LT at a medium-sized center (aOR: 0.17; CI: 0.03–0.88) has a protective effect on the development of TCMP. Increased health-care utilization in the form of mechanical ventilation, hemodialysis, vasopressors, and intra-aortic balloon pumps is observed in patients with TCMP. This resulted in increased length of stay and cost in patients with TCMP. Moreover, increased mortality was seen in patients who developed TCMP within the same calendar year. Conclusion: This is the first report showing the prevalence of TCMP in LTRs to be 0.5%. Older females with increased comorbidity are predisposed to TCMP. Patients who developed TCMP necessitate a higher acuity of medical care and cause an increased health-care burden and ultimately experience an increase in mortality.

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Medicine by Alexandros G. Sfakianakis,Anapafseos 5 Agios Nikolaos 72100 Crete Greece,00302841026182,00306932607174,alsfakia@gmail.com,

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Primary Care Dentistry and Oral Health

Call for dialogue: Primary care, dentistry, oral medicine, and public health Raman Kumar Journal of Primary Care Dentistry and Oral Health 2020 1(1):1-2 The Journal of Primary Care Dentistry and Oral Health has been established with the aim of promoting interdisciplinary research within an academic domain that is of paramount significance but often neglected the most. Poor oro-dental health leads not only to considerable morbidity but also costs to individuals, community, and governments in economic terms. The primary care setting uniquely offers the opportunity to deliver oral health care to the population as part of a comprehensive health-care package. The editorial team of the journal welcomes all primary care, dental and oral health, and public health professionals to support this unique area of human need through their scholastic work.

Are dentists suicide prone? The current scenario Gunjan Kumar, Payal Dash Journal of Primary Care Dentistry and Oral Health 2020 1(1):3-7 There is a widely discussed belief that dentist are at a high risk for suicide. Since 1960, dental journal have been carrying articles with headline like “The suicidal professions.” While this claim is often accepted without question, there are little reliable data that support the alleged risk and on the contrary few data even suggest the opposite. In India, few cases of suicide among dental student have been reported, but not much data are available. This paper aims at presenting a review of literature related to this complex issue and it shows that occupation is not a major predictor of suicide and it does not explain about why person commit suicide.

Role of curcumin as an antioxidant Tarun Vyas Journal of Primary Care Dentistry and Oral Health 2020 1(1):8-11 In recent years, there is an upsurge in the areas related to newer developments in prevention of diseases, especially the role of free radicals and antioxidants; free radicals are unstable chemicals formed in the body during normal metabolism or exposure to environmental toxins such as pollutants in air, food, and water. Curcumin combined with enhancing agents provides multiple health benefits. Most of these benefits can be attributed to its antioxidant and anti-inflammatory effects. Ingesting curcumin by itself does not lead to the associated health benefits due to its poor bioavailability, which appears to be primarily due to poor absorption, rapid metabolism, and rapid elimination. There are several components that can increase bioavailability. The purpose of this review is to provide a brief overview of the plethora of research regarding the health benefits of curcumin.

Internet addiction and its psychosocial impact on urban adolescents of Kanpur, Uttar Pradesh Rahul Srivastava, Devina Pradhan, Lokesh Sharma, Bhuvan Jyoti, Omveer Singh Journal of Primary Care Dentistry and Oral Health 2020 1(1):12-15 Background: Internet addiction is defined as any online-related, compulsive behavior which interferes with normal living and causes severe stress on family, friends, loved ones, and one's work environment. The adolescents are most vulnerable to the numerous addictive temptations offered by the Internet during the transition phase. The present study aims to evaluate the prevalence of Internet addiction in adolescents of urban areas of Kanpur district and assess the association of Internet addiction with stress, anxiety, and depression. Materials and Methods: A cross-sectional study was conducted among students of higher secondary schools/colleges in the urban areas of Kanpur district in Uttar Pradesh. Out of 105 colleges, 10%, i.e., 10 colleges, were selected randomly and a total of 900 students were enrolled in the study. A pretested, predesigned questionnaire, Young's Internet Addiction Scale, and Depression Anxiety Stress Scales 21 were used in the study. Data distribution was assessed for normality using the Shapiro–Wilk test. Categorical data were compared using the Chi-square test. All values were considered statistically significant for a value of P ≤ 0.05. Results: Majority (61.1%) of the respondents were females, and the mean age was 17.20 years. The prevalence of Internet addiction was 89.78%. The main purpose of using Internet was social networking (54.89%), followed by online gaming/gambling (19.67%) and study (12.89%). About 60.44% of the respondents used Internet for 3–6 h/day and 28.67% of the respondents used Internet for <3 h/day. There was a significant association between Internet addiction and stress (odds ratio = 33.55), depression (odds ratio = 0.99), and anxiety (odds ratio = 5.25). Conclusion: Internet addiction is a much quieter problem, and as such, it may be more readily disregarded or not even recognized as a problem. As parents and caregivers, understanding how to differentiate between normal Internet use and compulsive use is critically important.

Endodontic management of mandibular second premolar with three canals Payal Jain, Shubham Jain, Deepali Jain, Prashant Purandhar Shetty Journal of Primary Care Dentistry and Oral Health 2020 1(1):16-18 Knowledge of root canal morphology has been a complex and utmost important issue regarding the planning and implementation of root canal therapy. In addition to having adequate knowledge on periapical radiographs from different angles, careful examination of pulp chamber floor and the use of technological advances are also salient factors that contribute to the diagnosis of additional roots and canals. The occurrence of three canals with three separate (Type V, Vertucci) foramina in mandibular premolars is very rare. This article reports and discusses the treatment for an atypical occurrence of three canals with three separate foramina in the mandibular second premolar.

Reattachment an immediate esthetic protocol Pradeep Bapna, Darshit Jain, Barkha Udhani, Prashant Purandhar Shetty Journal of Primary Care Dentistry and Oral Health 2020 1(1):19-22 The immediate fragment reattachment is a conservative treatment which allows the restoration of the original dental anatomy thus rehabilitating function and esthetics in a shortest time available. Dentists are confronted with managing dental trauma and restoring fractured teeth on a regular basis. Hence, the technique that speed and simplify treatment, restore esthetics and improve long-term success rate are therefore of potential value and should be considered. Fracture reattachment possess challenging conservative and economically viable procedure within a single visit. This article discusses fragment reattachment technique and presents clinical case of coronal fracture involving enamel, dentin, and pulp.

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Medicine by Alexandros G. Sfakianakis,Anapafseos 5 Agios Nikolaos 72100 Crete Greece,00302841026182,00306932607174,alsfakia@gmail.com,

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Cardiovascular Nursing

The Efficacy of Psychological Interventions on Health-Related Quality of Life for Patients with Heart Failure and Depression: A Systematic Review Background Depression is prevalent among adults with chronic heart failure (CHF) and is associated with higher rates of morbidity and mortality and higher healthcare costs. Objectives The aim of this study was to explore the efficacy of psychological interventions in reducing depression and improving quality of life and clinical outcomes (mortality, hospitalization) among adults with CHF. Methods This study performed a systematic review involving searches of 6 databases (MEDLINE, CINAHL, EMBASE, PsycINFO, ASSIA, and SSCI), the Cochrane library, and gray literature, completed in January 2020. Experimental and nonexperimental quantitative studies of psychological interventions for adults with CHF were included. Each study was quality appraised, and key data were extracted and tabled. Overall findings are presented as a narrative synthesis. Results Nine studies met eligibility. Study authors sampled 757 participants and evaluated 4 psychological interventions: cognitive behavioral therapy alone or combined with exercise, mindfulness-based psychoeducation, coping skills training, and innovative holistic meditation. Cognitive behavioral therapy was significantly associated with improved depression and quality of life, and reduced hospitalization risk. Mindfulness-based psychoeducation, holistic meditation, and coping skills training positively impacted depression and quality of life. Coping skills training also reduced hospitalization and mortality risks. Conclusion Although this review indicates that psychological interventions can be beneficial to adults with CHF who have depression, the overall weight of evidence contains a number of biases. Larger, higher-powered studies are needed to confirm or refute these findings and to better understand how specific intervention and sample characteristics relate to outcomes. The authors have no funding or conflicts of interest to disclose. Catherine Evans (co-author) is funded by Health Education England/National Institute of Health Research (NIHR) Senior Clinical Lectureship (ICASCL-2015-01-001). Correspondence Sameera I. Helal, MSN, BSN, Faculty of Nursing, Midwifery and Palliative Care, Cicely Saunders Institute of Palliative Care, Rehabilitation and Policy, King's College London, Bessemer Rd, London SE5 9PJ, England(sameera.helal@kcl.ac.uk). Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved

Psychometric Properties of the Polish Version of the Self-Care of Hypertension Inventory Background According to evidence-based guidelines, adherence to blood pressure–lowering medication and lifestyle modifications is a crucial part of hypertension management. Self-care is an effective method for secondary prevention. However, patients continue to exhibit major deficits in terms of adherence, self-control, and self-care. Standardized instruments for the effective monitoring of patients' self-care abilities are still lacking. Objective The objectives of this study were to produce a translation and cross-cultural adaptation of the Self-Care of Hypertension Inventory (SC-HI) and to evaluate the psychometric properties of its Polish version. Methods The scale underwent translation and psychometric assessment using the standard methodology (forward-backward translation, review, psychometric analysis, criterion validity). The study included 250 patients, with a mean age of 61.23 ± 14.34 years, treated in a hypertension clinic. Results Mean self-care levels were evaluated in 3 domains: self-care maintenance (56.73 ± 18.57), self-care management (64.17 ± 21.18), and self-care confidence (62.47 ± 24.39). The Cronbach α for each domain showed satisfactory parameters: 0.755 for maintenance, 0.746 for management, and 0.892 for confidence. In the Polish version, the 3-factor structure of the SC-HI was not directly confirmed. Therefore, so-called modification indices were applied to obtain a standardized root mean square residual value less than 0.09 and a root mean square error of approximation value less than 0.06. Conclusions The SC-HI has been successfully translated and adapted for Polish settings, and is suitable for application among patients with hypertension. This work was prepared under the project financed from the funds granted by the Ministry of Science and Higher Education in the "Regional Initiative of Excellence" program for the years 2019–2022, project number 016/RID/2018/19 (http://www.rid.umed.wroc.pl/). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the article. All data and materials used in this research are freely available. References have been provided. The study was approved by the local bioethics committee (approval no. KB 42/2019). All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000. Written informed consent was obtained from all individual participants included in the study. All coauthors have agreed to the submission and publication of this article. All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; gave final approval of the version to be published; and agree to be accountable for all aspects of the work. The authors have no conflicts of interest to disclose. Correspondence Beata Jankowska-Polańska, PhD, Department of Clinical Nursing, Wroclaw Medical University, K. Bartla 5, 51-618 Wroclaw, Poland (beata.jankowska-polanska@umed.wroc.pl). This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal. Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved

Resilience and Depressive Symptoms in Adults With Cardiac Disease: A Systematic Review Background Depressive symptoms predict hospitalization and mortality in adults with cardiac disease. Resilience, defined as a dynamic process of positively responding to adversity, could protect against depressive symptoms in cardiac disease. No systematic review has been conducted on the relationship between these variables in this population. Objective The aim of this review was to explore the association between psychological resilience and depressive symptoms in adults with cardiac disease. Methods Seven databases (PubMed, EMBASE, CINAHL, PsycInfo, Web of Science, SCOPUS, and Cochrane) were searched from inception to December 2019 using the search terms "cardiac disease," "depressive symptoms," "depression," and "resilience." Inclusion criteria dictated that studies reported original research on the association between resilience and depressive symptoms in adults with a cardiac disease broadly defined. Quality ratings were performed by 2 independent raters. Results We identified 13 studies for final review. Study sample sizes ranged from 30 to 1022 participants, average age ranged from 52 to 72 years, and all studies had majority male participants (64%–100%). Resilience and depressive symptoms were inversely related in 10 of 13 studies. The 3 studies with poor-quality sampling techniques or significant loss to follow-up found no relationship. Conclusions Resilience seems to protect against depression in adults with cardiac disease. Gaps in the literature include poor understanding of the direction of causality. Methods of promoting resilience need to be identified and studied. The authors have no funding or conflicts of interest to disclose. Correspondence Amy Ketcham, BSN, RN, School of Nursing, University of Pennsylvania, 418 Curie Blvd, Philadelphia, PA 19104 (aketcham@nursing.upenn.edu). Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.jcnjournal.com). Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved

Development and Validation of a Scale to Measure Self-efficacy and Self-management in People With Coronary Heart Disease Background Self-management is important in reducing coronary risk factors and in preventing recurrent cardiac events. An enabling factor that promotes self-management among patients with coronary heart disease (CHD) is self-efficacy. However, there is no standardized measure that captures self-efficacy and self-management concurrently in this population. Aim The authors of this study report on the development and validation of a brief scale to measure self-efficacy and self-management in patients with CHD. Methods Scale development and testing comprised (1) item generation, (2) content validity, and (3) pilot testing. The Heart Health Self-Efficacy and Self-Management (HH-SESM) scale includes 2 constructs: self-efficacy and self-management, measured concurrently. Components of the HH-SESM scale consisted of items related to behavioral and coronary risk factor modification. Survey data from 143 participants were used in exploratory factor analyses to test the factorial validity and internal consistency of the scale. Results Twelve items with the same response format were included in the exploratory factor analysis. The factor analysis revealed a single-factor solution accounting for 36.7% and 36.5% of the variance in scores of the self-efficacy and self-management scales, respectively. The correlation (r = 0.72, P < .001) between the self-efficacy and self-management constructs indicates moderate convergent validity. Cronbach α of self-efficacy (0.83) and self-management (0.81) constructs showed good internal consistency. Conclusion The HH-SESM is a brief, easy-to-administer, and reliable measure of self-efficacy and self-management in patients with CHD. The authors have no funding or conflicts of interest to disclose. All authors have agreed on the final version and meet the following criteria (recommended by the International Committee of Medical Journal Editors [http://www.icmje.org/ethical_1author.html]): substantial contributions to conception or design of the work; acquisition, analysis, or interpretation of data for the work; drafting the work or revising it critically for important intellectual content; final approval of the version to be published; and agreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.jcnjournal.com). Correspondence Maria Mares, BN(Hons), RN, Building 7, Campbelltown campus. Narellan Rd, Cnr David Pilgrim Dr & Goldsmith Ave, Campbelltown, New South Wales, Australia (M.Mares@westernsydney.edu.au). Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved

Naturalistic Decision Making in Everyday Self-care Among Older Adults With Heart Failure Background Every day, older adults living with heart failure make decisions regarding their health that may ultimately affect their disease trajectory. Experts describe these decisions as instances of naturalistic decision making influenced by the surrounding social and physical environment and involving shifting goals, high stakes, and the involvement of others. Objective This study applied a naturalistic decision-making approach to better understand everyday decision making by older adults with heart failure. Methods We present a cross-sectional qualitative field research study using a naturalistic decision-making conceptual model and critical incident technique to study health-related decision making. The study recruited 24 older adults with heart failure and 14 of their accompanying support persons from an ambulatory cardiology center. Critical incident interviews were performed and qualitatively analyzed to understand in depth how individuals made everyday health-related decisions. Results White, male (66.7%), older adults' decision making accorded with a preliminary conceptual model of naturalistic decision making occurring in phases of monitoring, interpreting, and acting, both independently and in sequence, for various decisions. Analyses also uncovered that there are barriers and strategies affecting the performance of these phases, other actors can play important roles, and health decisions are made in the context of personal priorities, values, and emotions. Conclusions Study findings lead to an expanded conceptual model of naturalistic decision making by older adults with heart failure. In turn, the model bears implications for future research and the design of interventions grounded in the realities of everyday decision making. This work was supported by the Agency for Healthcare Research & Quality (R21 HS025232). Dr Holden reports consultant payments from federal research grants awarded to the University of Wisconsin, Clemson University, Oregon Health & Science University, and Kent State University. He receives an annual honorarium for editorial duties from Taylor & Francis publisher. Dr Mirro reports grants from Biotronik Inc, the Agency for Healthcare Research and Quality, Medtronic plc, and Janssen Scientific Affairs; consulting fees/honoraria from iRhythm Technologies Inc and Zoll Medical Corporation; and nonpublic equity/stock interest in Murj, Inc/Viscardia. Dr Mirro's relationships with academia include serving as a trustee of Indiana University. Dr Toscos reports grants from Biotronik Inc, Medtronic plc, Janssen Scientific Affairs, and iRhythm Technologies, Inc. All other authors have no conflicts to disclose. The content is solely the responsibility of the authors and does not necessarily represent the official views of the Agency for Healthcare Research & Quality or Parkview Health. Correspondence Richard J. Holden, PhD, Regenstrief Institute, 1101 W 10th St #421, Indianapolis, IN 46202 (rjholden@iu.edu). Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved

A Pilot Study to Evaluate a Computer-Based Intervention to Improve Self-care in Patients With Heart Failure Background Cognitive dysfunction contributes to poor learning and impaired self-care (SC) for patients with heart failure. Objectives The aims of this study were to (1) evaluate the feasibility and acceptability of a nurse-led, virtual home-based cognitive training and SC education intervention to support SC and (2) evaluate the relationship between improvements in SC and cognitive change and examine 30-day readmission rates. Methods In this 2-phase pilot study, we used a prospective, exploratory design. In phase 1, recruitment criteria and retention issues threatened feasibility and acceptance. Significant modifications were made and evaluated in phase 2. Results In phase 2, 12 participants were recruited (7 women and 5 men). Feasibility was supported. All participants and the study nurse positively evaluated acceptability of the intervention. Median SC scores improved over time. Thirty-day hospital readmission rates were 25%. Conclusion Phase 1 indicates the intervention as originally designed was not feasible or acceptable. Phase 2 supports the feasibility and acceptability of the modified intervention. Further testing is warranted. This study was supported by NIH/NINR P20 NR015331-02 (funded as part of the University of Michigan School of Nursing, P20 Center for Complexity and Self-management of Chronic Disease [PIs: Debra Barton, PhD, RN, FAAN; Ivo Dinov, PhD], and Donald and Karin Allen Faculty Fund, Department of Health Behavior and Biological Sciences, School of Nursing, University of Michigan). The authors have no conflicts of interest to disclose. Correspondence Cynthia Arslanian-Engoren, PhD, RN, ACNS-BC, FAHA, FAAN, University of Michigan School of Nursing, 400 N Ingalls, Room 2176, Ann Arbor, MI 48109 (cmae@umich.edu). Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved

Translation and Psychometric Evaluation of the German Version of the Thirst Distress Scale for Patients With Heart Failure Background In patients with chronic heart failure, thirst can be perceived as an intensive and burdensome symptom, which may have a negative impact on patients' quality of life. To initiate thirst-relieving interventions, assessment of thirst and its related distress is essential. At the time of this study, no instrument was available to evaluate thirst distress in patients with heart failure in Germany. Objective The aims of this study were to translate the "Thirst Distress Scale for patients with Heart Failure" (TDS-HF) from English into German and to test validity and reliability of the scale. Methods The English version of the TDS-HF was translated into German. A linguistically and culturally sensitive forward-and-backward translation was performed. Psychometric evaluation included confirmatory factor analysis, reliability in terms of internal consistency, and concurrent validity. Results Eighty-four hospitalized patients (mean age, 72 ± 10 years; 29% female; mean left ventricular ejection fraction, 36% ± 12%; 62% New York Heart Association functional classes III–IV, 45% on fluid restriction) from an acute care hospital were involved in the study. The item-total correlation ranged from 0.58 to 0.78. Interitem correlations varied between 0.37 and 0.79. Internal consistency was high, with a Cronbach α of 0.89. There was a high correlation between the total score of the TDS-HF and the visual analog scale to assess thirst intensity (r = 0.72, P ≤ .001), and a low correlation with fluid restriction (r = 0.35, P = .002). Conclusions The evaluation of the German TDS-HF showed satisfactory psychometric properties in this sample. The instrument is usable for further research and additional psychometric testing. The authors have no funding or conflicts of interest to disclose. Correspondence Christiane Kugler, PhD, RN, FAAN, Faculty of Medicine, Institute of Nursing Science, Albert-Ludwigs-University Freiburg, Elsässer Str. 2-o, 79106 Freiburg, Germany (christiane.kugler@uniklinik-freiburg.de). Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved

The Influence of Preparedness, Mutuality, and Self-efficacy on Home Care Workers' Contribution to Self-care in Heart Failure: A Structural Equation Modeling Analysis Background Home care workers (HCWs) are increasingly caring for patients with heart failure (HF). Previous studies have shown that they contribute to HF patients' care, but how their preparedness and their relationship with patients (mutuality) influence caregiving is unknown, as well as the role of HCWs' self-efficacy. Objective Guided by the Situation-Specific Theory of Caregiver Contribution to HF Self-Care, we investigated the influence of HCWs' preparedness and mutuality on HCWs' contribution to HF self-care and the mediating effect of HCWs' self-efficacy in the process. Methods We conducted a cross-sectional survey of HCWs who cared for patients with HF. The survey included the Caregiver Preparedness Scale, Mutuality Scale, Caregiver Contribution to Self-Care of HF Index, and Caregiver Self-Efficacy in Contributing to Self-Care Scale. We performed structural equation modeling and a mediation analysis. Results A total of 317 HCWs employed by 22 unique home care agencies across New York, NY, completed the survey. They had a median age of 50 years, 94% were women, and 44% were non-Hispanic Black. Results demonstrated that mutuality had a direct influence on HCW contribution to self-care and preparedness influenced their contribution to self-care, but only through the mediation of self-efficacy. Conclusion Home care workers' preparedness, mutuality, and self-efficacy have important roles in influencing their contribution to HF self-care. As a workforce increasingly involved in the care of patients with HF, knowing the mechanisms underpinning HCWs' contribution to self-care may illuminate future interventions aimed at improving their contributions and HF patient outcomes. This research was made possible, in part, through a generous donation by Douglas Wigdor, Esq. Dr Sterling and this research are supported by the National Heart, Lung, and Blood Institute (K23HL150160). Dr Riegel is supported by the National Institute of Nursing Research of the National Institutes of Health (R01NR018196). REDCap at Weill Cornell Medicine is supported by Clinical and Translational Science Center grant UL1 TR002384. The authors have no conflicts of interest to disclose. Correspondence Madeline R. Sterling, MD, MPH, MS, Weill Cornell Medicine, 420 E 70th St, Box 331, New York, NY 10021 (mrs9012@med.cornell.edu). Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved

Health-Related Quality of Life in Patients With a Left Ventricular Assist Device (QOLVAD) Questionnaire: Initial Psychometrics of a New Instrument Background Patients with a left ventricular assist device are a unique and growing population who deserve their own valid, reliable instrument for health-related quality of life. Objective We developed and tested the Health-Related Quality of Life with a Left Ventricular Assist Device (QOLVAD) questionnaire. Methods In a prospective, descriptive study, patients from 7 sites completed the QOLVAD and comparator questionnaires. Construct validity was tested using confirmatory factor analysis. Convergent validity was tested using correlations of QOLVAD scores to well-established measures of subjective health status, depression, anxiety, and meaning/faith. Reliability and test-retest reliability were quantified. Results Patients (n = 213) were 58.7 ± 13.9 years old; 81.0% were male, 73.7% were White, and 48.0% had bridge to transplant. Questionnaires were completed at a median time of 44 weeks post ventricular assist device. The 5 QOLVAD domains had acceptable construct validity (root mean square error of approximation = 0.064, comparative and Tucker-Lewis fit indices > 0.90, weighted root mean square residual = 0.95). The total score and domain-specific scores were significantly correlated with the instruments to which they were compared. Internal consistency reliability was acceptable for all subscales (α = .79–.83) except the cognitive domain (α = .66). Unidimensional reliability for the total score was acceptable (α = .93), as was factor determinacy for multidimensional reliability (0.95). Total test-retest reliability was 0.875 (P < .001). Conclusion Our analysis provided initial support for validity and reliability of the QOLVAD for total score, physical, emotional, social, and meaning/spiritual domains. The QOLVAD has potential in research and clinical settings to guide decision making and referrals; further studies are needed. This study was supported by grants from the following sources: Abbott-Northwestern Hospital Foundation, Minneapolis Heart Institute Foundation, and Minnesota Nurses Association Foundation. The funding sources had no role in the collection, analysis, or interpretation of the data. Additional support for K.E.S. was received from Bethel University (sabbatical). P.E. received honoraria from or is a consultant for Abbott Laboratories and Medtronic (paid to the institution, not the individual). S.M.J. receives speaking honoraria from Abbot (modest) and consulting fees from Medtronic (minimal). S.H. is a consultant for Abbott Laboratories. E.Y.B. received grants from Impulse Dynamics, personal fees from American Regent, and grants from Medtronic Inc. B.H. received a grant (shared with K.E.S.) from Minnesota Nurses Association Foundation (completed). All were paid to Minneapolis Heart Institute Foundation to be managed (not paid to the individual). J.A.C. Received personal fees from Abbott and Medtronic and is a member of the scientific advisory committee for Medtronic and Procyrion—all outside the submitted work. K.E.S. and B.H. are coauthors of the QOLVAD questionnaire and hold it as intellectual property. BH does contract work with Lippincott/WK as a Nurse Educator Consultant. (JCVN is owned/published by Lippincott/Wolters Kluwer - which is the owner of a Lippincott Clinical Experiences product from which BH receives royalties). [The QOLVAD questionnaire has been granted without charge to others who request permission in advance for nonprofit use.] Correspondence Kristin E. Sandau, PhD, RN, FAHA, FAAN, Bethel University, 3900, Bethel Drive, St Paul, MN 55112 (k-sandau@bethel.edu). Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved

Health-Related Quality of Life Declines Over 3 Years for Congenital Heart Disease Survivors Background Because of medical advancements, many congenital heart disease (CHD) survivors are relatively symptom-free until adulthood, at which time complications may occur. Worsening health status likely drives a change in patient-reported outcomes, such as health-related quality of life (HRQoL), although change in HRQoL has not been investigated among adolescent and young adult CHD survivors. Objective The aims of the current mixed cross-sectional and longitudinal study were to (1) examine changes in HRQoL over 3 years and (2) identify any demographic (age, sex, estimated family income, and distance from medical center) and medical predictors (functional status and number of cardiac-related medications) of that change. Methods Baseline and 3-year follow-up data were obtained via an online survey of 172 CHD survivors (15–39 years old at baseline; 25% simple, 45% moderate, 30% complex) recruited from a pediatric hospital and an adult hospital. Medical predictors were abstracted from electronic medical records. Results After controlling for New York Heart Association functional class, mixed-effects models identified significant declines in all subscales of the Research and Development Corporation 36-Item Health Survey 1.0 across the 3-year timeframe. A lower estimated family income (≤$35 000) predicted more decline in physical functioning (b = 0.5, 95% confidence interval, 0.2–0.8; P = .001) and emotional functioning (b = 0.3, 95% confidence interval, 0.1–0.5; P = .017). No other significant demographic or medical predictors were identified. Conclusions Study findings highlight the importance of tracking patient-reported outcomes over time, suggesting that medical staff should discuss HRQoL with CHD survivors during late adolescence and early adulthood before decline. The authors have no conflicts of interest to disclose. This work was supported by the National Institutes of Health (grant number T32HL-098039) to J.L. Jackson, The Heart Center at Nationwide Children's Hospital, and the Clinical and Translational Science Award (grant number UL1TR001070) to The Ohio State University and Nationwide Children's Hospital. All authors take responsibility for all aspects of the reliability and freedom from bias of the data presented and their discussed interpretation. Correspondence Jamie L. Jackson, PhD, 700 Children's Drive, Columbus, OH 43205 (Jamie.jackson2@nationwidechildrens.org). Copyright © 2020 Wolters Kluwer Health, Inc. All rights reserved

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