Preliminary Report of Nationwide COVID-19 Vaccine Compensation in Taiwan.

The potential adverse effects of coronavirus disease 2019 (COVID-19) vaccinations raise public concerns. Data from Taiwan's Vaccine Injury Compensation Program (VICP) can provide valuable insights. This study analyzed the preliminary application data for COVID-19 vaccine compensation in Taiwan's VICP, focusing on applicants receiving vaccines between March 2021 and June 2022. Among the 2941 adverse events, 113 cases (3.8%) were deemed causally associated with vaccination, 313 (10.6%) were indeterminate, and 2515 (85.5%) had no causal association. Nearly half (47.6%) of the applicants were over 60 years old, and 76.6% had a history of pre-existing chronic diseases. Among the 426 vaccine-associated or indeterminate cases, the most common causes were hematological diseases and thrombosis. There were 920 mortality cases reported, and 97.4% were unassociated with vaccination. Only five deaths were judged to be associated with the COVID-19 vaccination, all involving the adenovirus vector vaccine and thrombosis with thrombocytopenia syndrome. In conclusion, most compensation applications were not causally linked to vaccination. Compared to other countries, the number of applications in Taiwan's VICP is relatively high. These findings may indicate a need to adjust the application requirements for compensation in Taiwan's program.

Herpes zoster in the context of immune reconstitution inflammatory syndrome in patients with rheumatic diseases: a single-center retrospective study.

Immune reconstitution inflammatory syndrome (IRIS) experienced in rheumatology practice is diverse and includes opportunistic infections such as herpes zoster (HZ). This study aimed to explore the risk of HZ in patients with rheumatic diseases in the perspective of IRIS. The study retrospectively reviewed the clinical courses of 20 patients with HZ and investigated the IRIS triggers such as the reduction or discontinuation of immunosuppressive drugs within 3 months and coronavirus disease 2019 (COVID-19) vaccination within 4 weeks prior to HZ development. Disease activity of the underlying rheumatic disease at HZ onset was evaluated using the physician's global assessment. Thirteen patients developed HZ after reducing or discontinuing immunosuppressive drugs, with mild and stable disease activity. In four of these cases, disease activity increased after dose reduction or discontinuation, and HZ subsequently developed. Two of the seven patients who did not reduce or discontinue immunosuppressive drugs received the COVID-19 vaccination. Fifteen patients (75%) had at least one of the two IRIS triggers. Four of the five patients who developed HZ without any IRIS triggers were at HZ risk. To conclude, IRIS, caused by the reduction or discontinuation of immunosuppressive drugs, may be involved in the development of HZ in rheumatology practice.

Effectiveness and safety of immune response to SARS­CoV­2 vaccine in patients with chronic kidney disease and dialysis: A systematic review and meta­analysis.

The coronavirus disease 2019 (COVID-19) vaccination is the most effective way to prevent COVID-19. However, for chronic kidney disease patients on long-term dialysis, there is a lack of evidence regarding the efficacy and safety of the immune response to the vaccine. The present meta-analysis explores the efficacy and safety of COVID-19 vaccine in the immune response of patients with chronic kidney disease (CKD) undergoing dialysis. PubMed, Web of Science, Science Direct, and Cochrane Library databases were systematically searched from January 1, 2020, to December 31, 2022. Data analysis was performed using REVMAN 5.1s and Stata14 software. Baseline data and endpoint events were extracted, mainly including age, sex, dialysis vintage, body mass index (BMI), vaccine type and dose, history of COVID-19 infection, seropositivity rate, antibody titer, pain at injection site, headache and other safety events. The meta-analysis included 33 trials involving 81,348 patients. The immune efficacy of patients with CKD and dialysis was 80% (95 CI, 73-87%). The seropositivity rate of individuals without COVID-19 infection was 76.48% (3,824/5,000), while the seropositivity rate of individuals with COVID-19 infection was 80.82% (1,858/2,299). The standard mean difference of antibody titers in CKD and dialysis patients with or without COVID-19 infection was 27.73 (95% CI, -19.58-75.04). A total of nine studies reported the most common adverse events: Pain at the injection site, accounting for 18% (95 CI, 6-29%), followed by fatigue and headache, accounting for 8 (95 CI, 4-13%) and 6% (95 CI, 2-9%), respectively. COVID-19 vaccine benefitted patients with CKD undergoing dialysis with seropositivity rate ≥80%. Adverse events such as fatigue, headache, and pain at the injection site may occur after COVID-19 vaccination but the incidence is low.

Effects of COVID-19 vaccination on cervical lymph nodes in patients with thyroid cancer.

Background: Cervical lymph node enlargement caused by coronavirus disease 2019 (COVID-19) vaccination has been reported, but little is known on whether the vaccination would influence preoperative cervical lymph node evaluation and its risk of lymph node metastasis in thyroid cancer. Methods: We retrospectively analyzed data of patients who underwent thyroid cancer surgery in Tangdu Hospital, China, from 1 March 2021 to 30 June 2021. A total of 182 patients were included in the cohort study. All patients with suspected malignant tumors underwent ultrasound (US)-guided fine needle aspiration (FNA) of thyroid lesions before surgery to confirm the diagnosis. Cervical lymph nodes were evaluated by preoperative physical examination and imaging. Wilcoxon rank-sum test and Fisher's exact test were used to evaluate the effect of vaccination on cervical lymph nodes in patients with thyroid cancer. Statistical significance was defined at P<0.05. Results: The patients were divided into two groups according to whether they had been vaccinated or not. Our results showed that there were no significant differences between the two groups in the brand of the vaccine, operation method, and the extent of surgery. Moreover, there was no significant difference in the evaluation of US characteristics of cervical lymph nodes between the two groups regardless of having the vaccination or not. Interestingly, US evaluation found that the experimental group's proportion of cervical lymph node enlargement increased significantly within 14 days after vaccination, which was statistically significant. Conclusions: This study found that vaccination against COVID-19 did not increase the number of cervical lymph node metastases, but inaccurate assessment of cervical lymph nodes in thyroid cancer patients within 14 days of vaccination (due to temporary lymph node enlargement) may lead to more extensive surgery.

COVID­19 vaccination in liver transplant recipients (Review).

Severe acute respiratory syndrome coronavirus 2 (Sars-CoV-2) infection has significantly affected immunocompromised individuals and subsequently, liver transplant recipients (LTRs). Early in the course of pandemic, this vulnerable population was prioritized for vaccination, after obtaining encouraging data about the vaccination benefits on disease severity and mortality. As the published knowledge was mainly supported from studies which were limited to the healthy population, the present review summarizes the data from the literature on coronavirus disease 2019 (COVID-19) vaccination in LTRs and the available vaccination guidelines of international societies. The COVID-19 vaccination of LTRs is strongly recommended as a safe and effective measure in order to prevent severe disease and mortality.

Safety of coronavirus disease 2019 vaccines in 213 adult patients with sickle cell disease.

Given the lack of information about safety of the COVID-19 vaccines for sickle cell disease (SCD) patients, we sought to determine whether COVID-19 vaccine was associated with subsequent hospital admission for vaso-occlusive events (VOEs). We included 402 patients with SCD, including 88 regularly transfused. As of July 31, 2021, 213 (53.0%) of them had received a least one dose of COVID vaccine (Pfizer 93.0%). We showed similar risk of hospital admission for a VOE among vaccinated patients (whether transfused or not) and among a control group of non-vaccinated patients matched for age, sex and genotype.

Inflammatory myopathy following coronavirus disease 2019 vaccination: A systematic review.

Introduction: Reports of unexpected side effects have accompanied the vaccination of larger proportions of the population against coronavirus disease 2019 (COVID-19), including a few cases of inflammatory myopathy (IM). In a bid to improve understanding of the clinical course of vaccine complications, a systematic review of reported cases of IM following COVID-19 vaccination has been conducted. Methods: The PRISMA guideline 2020 was followed. Two independent investigators systematically searched PubMed and Embase to identify relevant studies published up to July 2022, using the following keywords: COVID-19 Vaccine, inflammatory myositis. The Joanna Briggs Institute critical appraisal tools were used for the risk of bias. Results: A total of 24 articles presenting clinical features of 37 patients with IM following COVID-19 vaccine were identified. Female patients composed 59.5% of cases and 82.4% had been vaccinated with BNT162b2 or ChAdOx1. Onset of symptoms occurred within 2 weeks of the first or second vaccine dose in 29 (85.3%) patients and included muscular weakness in 54.1% and skin rash in 71.4% of patients. Myositis specific autoantibodies (MSAs) and myositis associated autoantibodies (MAAs) were reported in 28 patients. Specific clinical subtypes of myositis, reported in 27 patients, included 22 (81.5%) cases of dermatomyositis (DM) and 3 (11.1%) cases of immune-mediated necrotizing myopathy (IMNM). Following treatment, 32 (86.5%) patients showed improvement on follow-up. Conclusion: COVID-19 vaccine may induce various clinical myositis subtypes and related antibodies. Muscular weakness was the most common presenting symptom. Clinicians should be aware of this unexpected adverse event following COVID-19 vaccination and arrange for appropriate management. Systematic review registration: INPLASY https://inplasy.com/inplasy-2022-9-0084/ [INPLASY202290084].

COVID-19 vaccination and myocarditis: A review of current literature.

Vaccination for coronavirus disease 2019 (COVID-19) is a critical strategy in controlling the current pandemic of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). After widespread COVID-19 vaccine imple-mentation, isolated case reports about myocarditis as a potential adverse reaction started coming. As of November 12, 2021, Centers for Disease Control and Prevention (CDC) has reported 1793 cases of myocarditis or pericarditis among young people with age 12-29 years, most cases have been reported in the male adolescent age group after the second dose of mRNA COVID-19 vaccines. It is very important to monitor the safety standards and adverse reactions of vaccines to effectively implement the vaccination policies. The CDC and the United States Food and Drug Administration actively monitor vaccine-associated adverse reactions a well-known platform such as Vaccine Adverse Event Reporting System. CDC continues to recommend COVID-19 vaccines and booster doses for eligible individuals (age limit according to the type of vaccine) after careful consideration from risk-benefit assessment and favorable outcomes from vaccination. Mechanisms behind COVID-19 vaccine-induced myocarditis are not clear yet but several possibilities such as molecular mimicry between the spike protein of SARS-CoV-2 and self-antigens, immune response to mRNA, and activation of host immunological system, trigger of the pre-existing dysregulated immunological system have been documented in the literature. Overall, data suggests a good prognosis, especially in young patients. In this review article, we cover currently available data on COVID-19 vaccine-related myocarditis incidence, concerns, possible mechanisms of myocarditis, current treatment, and outcome trends, risk vs benefit assessment of COVID-19 vaccination in this current pandemic.

Rapid Progression of Polypoidal Choroidal Vasculopathy following Third BNT162b2 mRNA Vaccination.

The study aimed to describe a case of rapid progression of polypoidal choroidal vasculopathy (PCV) following the third administration of the Pfizer-BioNTech (BNT162b2) mRNA vaccine. A 79-year-old Japanese man visited our hospital with a 1-week history of blurred vision in the left eye 16 h following the administration of the third BNT162b2 mRNA vaccine. The clinical examinations and imaging tests revealed massive submacular hemorrhage (SMH) and excessive subretinal fluid (SRF), owing to PCV in the left eye. No ocular abnormality was observed in the right eye. His medical history included diabetes and ocular history included cataracts, nonproliferative diabetic retinopathy, glaucoma in both eyes, and irregular retinal pigment epithelium elevation in the left eye. Since he received a single intravitreal injection of aflibercept approximately 2 years ago for the treatment of diabetic macular edema in the left eye, the left eye was stable. We performed an intravitreal injection of bevacizumab and combined phacoemulsification with pars plana vitrectomy with gas, including subretinal injection of tissue plasminogen activator to displace the SMH. Thirteen days after the surgery, the SMH and SRF decreased. Although rare, mRNA COVID-19 vaccine administrations could be associated with PCV deterioration.

Healthcare Economics of a Coronavirus Disease 2019 Pop-Up Vaccination Center.

Introduction: Creation of pop-up vaccination sites at trusted community locations has been encouraged to address vaccine hesitancy and provide equitable access to COVID-19 vaccination in minority communities. This study sought to study the healthcare economics of a community-based COVID-19 pop-up vaccination center in terms of the following: costs associated with operating the vaccination center, analysis of billing data from patients who received the Moderna COVID-19 vaccine, and costs of hospitalization for COVID-19 which may be avoided with widespread vaccination. Methods: The pop-up vaccination center was located in Port Jefferson Station, NY, USA. Costs associated with operation of the COVID-19 pop-up vaccination center were quantified, itemized, and tabulated. Current Procedural Technology codes were used to identify patients who received the Moderna COVID-19 vaccine. Billing data were quantified for the cohort as well as per each patient to receive the vaccine. Costs associated with provision of urgent care, emergency, and hospital services to patients with COVID-19 were obtained. Results: The total cost to operate the vaccination center was $25,880. The vaccination center administered the initial dose of the Moderna COVID-19 vaccine to N=251 patients between March and May, 2021. The standard hospital costs for patients admitted to the medical ICU due to COVID-19 ranged from $8,913 to $190,714, per patient. Conclusion: Since the Moderna COVID-19 vaccine series is effective in preventing hospitalization for 93% of patients, this community-based vaccination center's administration of the vaccine series to 240 patients meant aversion of hospitalization due to COVID-19 related morbidity for 223 patients. Therefore, the true impact of this vaccination center, measured in averted hospital costs, ranges from $1,987,599 to $42,529,222.

[Investigation of Foreign Particles in Moderna COVID-19 Vaccine].

Particular batches of Moderna mRNA Coronavirus Disease 2019 (COVID-19) vaccine were recalled after foreign particles were found in some vaccine vials at the vaccination site in Japan in August 2021. We investigated the foreign particles at the request of the Ministry of Health, Labour and Welfare. Energy dispersive X-ray spectroscopy analysis suggested that the foreign particles found in the vials recalled from the vaccination sites were from stainless steel SUS 316L, which was in line with the findings of the root cause investigation by the manufacturer. The sizes of the observed particles ranged from <50 µm to 548 µm in the major axis. Similar foreign particles were also detected in 2 of the 5 vaccine vials of the same lot stored by the manufacturer, indicating that the foreign particles have already been administered to some people via vaccine. Observation of the vials of the same lot by digital microscope found smaller particles those were not detected by visual inspection, suggesting that more vials were affected. Contrarily, visual inspection and subvisible particulate matter test indicated no foreign particles in the vials of normal lots. Possible root cause and strategies to prevent such a deviation were discussed from technical and regulatory aspects.

Messenger ribonucleic acid vaccine-associated immune thrombocytopenia: A rare complication of vaccine.

Coronavirus disease-2019 continues to have a serious impact in countries with the effect of new variant viruses emerging with mutations. While the effectiveness and protection of the vaccine have been determined all over the world, some vaccine-related side effects can be detected in the form of cases. In our case, the patient was admitted to the emergency department of our hospital with complaints of weakness and progressive rash on his legs. Diffuse petechiae purpura on the legs of the patient was observed and complete blood count revealed thrombocytopenia. Peripheral blood smear supported the blood count test results with thrombocytopenia, secondary causes of thrombocytopenia were excluded, and the patient was diagnosed with vaccine-induced immune thrombocytopenia.

De novo Minimal Change Disease in an Adolescent after Pfizer-BioNTech COVID-19 Vaccination: A Case Report.

This is the first report in an adolescent of minimal change disease (MCD) after the first injection of the BNT162b2 COVID-19 vaccine (Pfizer-BioNTech) with complete remission following steroid treatment. An 18-year-old white male with no prior medical history complained of gastrointestinal symptoms 11 days after his vaccination. Ascites and lower extremity edema were observed a few days later. He was admitted to a hospital as laboratory testing revealed proteinuria of 10.5 g/24 h, normal creatinine levels, and serum albumin of 1.8 g/dL, confirming the presence of nephrotic syndrome. Immunology and serology tests were unremarkable. A diagnostic kidney biopsy showed no significant glomerular or tubular abnormalities in light microscopy with negative immunofluorescence. Treatment with methylprednisolone 48 mg daily was initiated. A week after discharge, proteinuria declined to 1.2 g/24 h, and edema had disappeared, and 6 weeks later, complete remission was evident. As COVID-19 vaccination has been associated with the development of de novo and relapsing MCD, and this case provides additional support for this possible correlation.

Constrictive pericarditis following mRNA COVID-19 vaccination in a patient with systemic sclerosis.

A 59-year-old man with systemic sclerosis and interstitial pneumonia was referred to our department because he developed dyspnea and leg edema after receiving a first shot of coronavirus disease 2019 (COVID-19) vaccine. Transthoracic echocardiography showed moderate pericardial effusion with conspicuous fibrin deposition. Prednisolone was increased from 6 mg/day for systemic sclerosis to 20 mg/day. Thereafter, pericardial effusion gradually decreased. However, his symptoms continued. Transthoracic echocardiography showed disappearance of pericardial effusion and thickened pericardium. Pulsed-wave and tissue Doppler echocardiography revealed that the patient suffered from newly developed constrictive pericarditis. COVID-19 vaccination might have contributed to acute pericarditis and subsequent constrictive pericarditis in the present case of systemic sclerosis and pulmonary fibrosis. Learning objective: Incidence of adverse effects after coronavirus disease 2019 vaccination is rare. The present case suggests the risk of pericarditis that may lead to constrictive pericarditis.

Willingness to receive COVID-19 vaccination in people living with HIV/AIDS from Latin America.

BACKGROUND: Prior research has established some risk factors for an increased risk of severe disease and mortality from coronavirus disease 2019 (COVID-19). However, the impact of HIV infection on SARS-CoV-2 susceptibility and severity is a significant gap in the literature. In the same way, not many studies across the globe have analyzed the degree of vaccination willingness among people living with HIV/AIDS (PLWHA) and considerations regarding prioritizing this population during vaccination plans, particularly in developing countries. METHODS: A descriptive-analytical cross-sectional study was conducted. Self-completed electronic surveys directed to PLWHA were performed via Twitter in February 2021, using accounts of HIV activists. RESULTS: 460 (87.1%) participants were willing to be vaccinated with any COVID-19 vaccine. The reasons for that were listed as 1) the belief that vaccination prevents both the COVID-19 infection (81.3%) as well as being a spreader (52.2%); 2) having a high occupational risk of becoming infected with COVID-19 (22%); and 3) the belief that they would be at high risk of death because of COVID-19 (21.3%). Only 56 (10.6%) participants expressed hesitancy toward vaccination, and 12 (2.2%) stated they did not want to get vaccinated. CONCLUSIONS: Our results may support the prioritization of people living with HIV during the implementation of vaccination plans in developing countries. New strategies should be adopted to overcome the hesitancy and unwillingness toward the COVID-19 vaccination, especially in populations with risk factors for severe disease.

Histopathological analysis of skin reactions after coronavirus disease 2019 vaccination: Increment in number of infiltrated plasmacytoid dendritic cell.

Skin disorders are frequent adverse events after coronavirus disease 2019 (COVID-19) vaccination. However, the pathogenesis of these disorders is not fully understood. Here, we report a case series of cutaneous adverse events following COVID-19 vaccination, and the results of our investigation reveal the underlying mechanism. Case 1: a 47-year-old female developed a wheal, confined to the COVID-19 vaccination site, 2 days after her first injection. She was treated with topical steroids and oral antihistamines. Case 2: a 51-year-old female showed generalized petechial erythema accompanied by fever, genital bleeding, thrombocytopenia, liver dysfunction, and disseminated intravascular coagulation, 2 days after her second injection. She was diagnosed with vaccine-induced macrophage activation syndrome and treated with anti-inflammatory therapy. Immunohistological analysis of the skin eruption, in both these cases, showed infiltration of CD123+ BDCA2+ plasmacytoid dendritic cells (p-DC). Despite the distinctive clinical features in these two cases, this finding suggests that p-DC might be involved in different cutaneous adverse events after COVID-19 vaccination.

Acute disseminated encephalomyelitis with bilateral optic neuritis following ChAdOx1 COVID-19 vaccination.

BACKGROUND: Acute disseminated encephalomyelitis (ADEM) is a rare immune-mediated inflammatory demyelinating disease of the central nervous system. We report a case of ADEM presenting with bilateral optic neuritis temporally associated with the ChAdOx1 vaccine against SARS-COVID19 virus. CASE PRESENTATION: A 36-year-old female presented with bilateral optic neuritis following her first dose of the ChAdOx1 vaccine. Initial MRI Brain showed evidence of demyelination within the subcortical white matter, with no radiological involvement of the optic nerves. Visual evoked potentials were consistent with bilateral optic neuritis which was confirmed radiologically on follow up MRI. She was treated with intravenous steroids with improvement both in symptoms and radiological appearance. A pseudo-relapse occurred which was treated with a further course of intravenous steroids followed by an oral taper. The clinical, radiological and serological results were most consistent with diagnosis of ADEM. CONCLUSIONS: ADEM is an exceedingly rare complication of ChAdOx1 vaccine despite millions of doses. While it is imperative clinicians remain aware of neurological complications of vaccines, the importance of vaccination to control a pandemic should not be undermined.

Recurrent Kounis syndrome - a life-threatening event after COVID-19 vaccine administration.

Kounis syndrome is an acute coronary syndrome occurring in the setting of a hypersensitivity reaction. It occurs as a consequence of mast-cell activation and degranulation causing coronary artery spasm, atherosclerotic plaque erosion, or stent thrombosis. We report the case of a man who presented to the emergency department with typical angina that started 20 minutes after coronavirus disease 2019 (COVID-19) vaccine administration. Electrocardiogram showed inferior ST-elevation myocardial infarction, and coronary angiography confirmed right coronary artery stent thrombosis. Five months before, he had an acute coronary syndrome after influenza vaccine administration. Both vaccines share a common excipient, polysorbate 80. Considering the reproducibility of the reaction and the temporal association between vaccine administration and coronary events, a hypersensitivity reaction to polysorbate 80 was admitted and the patient was instructed to further avoid drugs containing it. To our knowledge, this constitutes the first reported case of type 3 Kounis syndrome after COVID-19 vaccine administration. Kounis syndrome is an uncommon disease, often undiagnosed. Its recognition and proper management are crucial to prevent future events. .

Immune thrombocytopenia in 2 healthy young women after the Pfizer-BioNTech BNT16B2b2 messenger RNA coronavirus disease 2019 vaccination.

Immune thrombocytopenic purpura (ITP) is a rare complication associated with vaccines targeting various diseases, including influenza, measles-mumps-rubella, hepatitis B, and diphtheria-tetanus-pertussis. We report 2 cases of ITP in healthy 20-year-old and 21-year-old women presenting to Emory University in Atlanta, GA, 2 days after the second dose and 11 days after the first dose (respectively) of the Pfizer-BioNTech messenger RNA severe acute respiratory syndrome coronavirus 2 vaccine. Both patients recovered quickly. With more than a billion doses of coronavirus disease 2019 vaccines safely administered worldwide as of May 2021, discussions with patients should put into perspective the low risks of vaccination against the enormous societal benefit of the coronavirus disease 2019 vaccine.

Balancing risks: making decisions for maternal treatment without data on fetal safety.

Challenges arise when treatment to improve maternal health brings the possibility of risk to fetal health. The coronavirus disease 2019 (COVID-19) vaccine is the most recent, but hardly the only, example. Because pregnant patients are often specifically excluded from trials of new therapies, this is often the dilemma that patients and providers face when considering new treatments. In this study, we used the COVID-19 vaccine as an exemplar to question the broader issue of how society, in general, and obstetricians, in particular, should balance obligations to pregnant women's right of access to new therapeutic agents with the physician's desire to protect the fetus from potential risks. We will argue that in almost all circumstances (with few exceptions, as will also be discussed), maternal benefit and respect for autonomy create the uncertainty that absent safety data bring. Consequently, if pregnant women choose to try new interventions and treatments, such as the COVID-19 vaccination, they should be offered those new regimens and their decision supported. In addition, we will argue that the right solution to avoid the dilemma of absent data is to include pregnant individuals in clinical trials studying new treatments, drugs, and other therapies. We will also discuss the basis for our opinion, which are mainstream obstetrical ethics, precedents in law (supreme court ruling that forbids companies to exclude women from jobs that might pose a risk to the fetus), and historic events (thalidomide). The ethical framework includes the supposition that sacrifice to improve fetal outcome is a virtue and not a mandate. Denying a pregnant patient treatment because of threats to their life can create absurd and paradoxical consequences. Either requiring abortion or premature delivery before proceeding with treatments to optimize maternal health, or risking a patient's own life and ability to parent a child by delaying treatment brings clear and significant risks to fetal and/or neonatal outcomes. With rare exceptions, properly and ethically balancing such consequential actions cannot be undertaken without considering the values and goals of the pregnant patient. Therefore, active participation of both the pregnant patient and their physician in shared decision making is needed.