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Background: From the literature emerges that having a pregnancy and especially a high-risk pregnancy in time of pandemic can lead to an increase of the levels of anxiety, which are usually already higher in relation to maternal-fetal disease. Furthermore, the literature shows that significant organizational and methodological changes have been introduced in the detection of psychological conditions, such as the introduction of telehealth intervention. Particularly in our experience about psychological health screenings there was a period of care interruption (between 11.03.2020 and 04.05.2020) and a clinical activity restructuring on the ward according to the new needs that have accrued. The aim of this experience is to analyze the progress of psychological health perinatal screening in women during the Covid-19. Specifically, we aimed to understand the percentage of positive screening and management compared to the pre-pandemic period. Method(s): Perinatal psychological screening was administered to women with high-risk pregnancy hospitalized in a Obstetric ward in a period between May 2020 to December 2021. The data were then compared with those recorded from September 2019 to February 2020 (pre-Covid-19). Screening consists in the description of the Obstetrical Psychology Service, the case history, the self-administration questionnaire GHQ-12 (General Health Questionnaire- 12) and the assessment interview if necessary. Result(s): A total of 469 screenings were administered during the pandemic, about 30% of which were found to be positive in the screenings (2020-21). Specifically in 2020, the positivity amounted to 28.69%. Of these 64 women, 56 performed the assessment, and in particular 22 were taken to the Psychology Service, 6 were referred to the territorial counseling centers, and 28 didn't receive further treatment indication. In 2021, the positivity was 32.93%. Especially of these 81 women, 32 were taken to the Psychology Service, 10 were sent to the territorial counseling centers and, 16 refused the assessment interview, 6 were already in treatment, 11 didn't receive further treatment indications and 6 cases dropped out. In the pre-pandemic phase the rate of positivity was 27%. Of the 30 women who tested positive at the screening, 5 were taken to the Psychology Service, 9 were referred to family counseling centers in the area, 11 refused the assessment interview, and 5 didn't receive further therapeutic indication. Conclusion(s): The importance of psychological care continuity and the feasibility of administering psychological health screenings clearly emerges in the ward despite the changed health situation due to Covid-19. The results show how the positivity rate for psychological health screening increases over the years (27% from September 2019 to February 2020/pre-Covid-19, 28,69% from May to December 2020 and 32,93% in 2021).
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Introduction: Spatial neglect (SN) is a debilitating neuropsychological syndrome defined as a failure to respond to stimuli in the side of space opposite to the side of the brain injury. Despite the impact, there are currently no clinically effective rehabilitation methods. Computerised rehabilitation can increase enjoyment and feelings of independence (Morse et al.,2020), thus we developed computerised Spatial Inattention Grasping Home-based Therapy (c-SIGHT) which can remotely record adherence and facilitate self-administration. SIGHT, or visuomotor feedback training, or (grasping-to-lift and balance rods) has been shown to be effective in reducing SN (Rossit et al., 2019). Method(s): This research aims to investigate the feasibility of a randomized controlled trial using c-SIGHT vs. an attentional control, while also exploring experiences of self-administering the therapy at home. This is a two-arm, double-blinded feasibility study intends to recruit 46 stroke survivors with SN and allocate them using minimisation to self-administer c-SIGHT or an attentional control for 30 minutes, twice a day for 10 days at home. Participants complete a set of neuropsychological tests and questionnaires at three time points (baseline, post-training, one-month follow-up) and one semi-structured interview after using c-SIGHT. Primary outcomes are feasibility parameters (recruitment, blinding success, adherence, follow-up rates). Secondary outcomes are changes in neglect, cognition and activities of daily living. Result(s): Since May 2021, the study has opened up at five NHS sites in the East of England. Despite COVID-19 delays, 20 stroke survivors have been recruited, 11 completed baseline assessments, and four have completed the study. Conclusion(s): Other preliminary results (e.g., usability) will be presented.
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Introduction: The use of biological therapy in eosinophilic and atopic asthma has grown exponentially over the last 14years. Treatment was initially hospital-based, but the COVID-19 pandemic has accelerated the implementation of patient homecare self-administration (HSA) of biologics. Aim(s): To assess the stability of patients transfered on HSA by comparing data from biologic initiation to HSA discharge and annual review. Result(s): This report includes 56 patients who attended for annual review between April and December 2021 (60% female, mean age 54 [SD13.4]) for Benralizumab (42.9%), Mepolizumab (35.7%) and Omalizumab (21.4%). The time on biologic when commencing HSA was 19 (IQR 21.8) months, with an annual review 12 (IQR 8.3) months later. Previously obtained improvements in asthma control, lung function, eosinophil suppression and oral corticosteroid use, were maintained in 53(95%) of the patients (Table 1). HSA was stopped in 3(5%) patients due to deterioration in asthma control. Conclusion(s): The vast majority of patients recieving HSA of biologics maintained previous improvements across asthma outcomes, thereby strongly supporting the use of HSA in the correctly identified patient, consequently optimising service capacity. Appropriate monitoring arrangements are still needed to promptly identify any deterioration. (Table Presented).
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Introduction: Fixed drug eruption (FDE) can have a wide array of culprits, especially in patients who use multiple medications. We present a patient with Fixed Drug Eruption (FDE) secondary to fluconazole. Case Description: A 36-year-old female was evaluated for recurrent pruritic and tender violaceous to hyperpigmented patches on her face (Figure 1A), neck, upper extremities, buttocks, flank, and genitals. Patches would blister after 2-3 days. These lesions occurred every 2-3 months for 1 year with Non-Steroidal Anti-inflammatory Drugs (NSAIDs) or fluconazole, and after her second Pfizer COVID-19 vaccine with acetaminophen as premedication. Punch biopsy showed focal dyskeratosis, papillary dermal eosinophils and neutrophils (Figure 1B). She was diagnosed with FDE and instructed to avoid NSAIDs, Polyethylene Glycol (PEG), over-the-counter medications, and fluconazole. Patch testing was performed for fluconazole (pet 5%), ibuprofen (pet 5%), celecoxib (pet 10%), povidone (pet 2% and liquid), and croscarmellose (pet 10% and liquid). All patch tests were negative at 48 hours, 72 hours, 5 days, and 7 days readings. Prior to performing a provocation test, the patient self-administered fluconazole for vaginal itching and the FDE recurred within 2 minutes on the same locations. She tolerated celecoxib and COVID19-vaccine booster without adverse reactions. The patient was instructed to avoid all azoles and use alternative agents. Discussion(s): When multiple possible agents are suspected in FDE, patch testing followed by provocation tests may be considered. In this case, the diagnosis was confirmed by self-administration of fluconazole. Copyright © 2022
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Background: Subcutaneous desmopressin (DDAVP) can be more easily administered than intravenous DDAVP and may be an efficacious alternative for the currently unavailable intranasal DDAVP to treat mild bleedings or for minor invasive procedures in von Willebrand disease (VWD) and hemophilia A. Aim(s): To compare the one-hour response to subcutaneous and intravenous DDAVP in patients with VWD or hemophilia A. Method(s): Patients with hemophilia A (FVIII <=10 IU/dl) or VWD (VWF activity <=10 IU/dl) whose treatment plans include DDAVP and who were to receive a COVID-19 vaccination were eligible to participate. For COVID-19 vaccination, FVIII or VWF activity target levels of >10 IU/dl were pursued according to international guidelines (ISTH). DDAVP was administered subcutaneously 1.5 h before vaccination. FVIII (in hemophilia and VWD) and VWF activity levels (in VWD) were determined prior to (t = 0) and 1 h after DDAVP (t = 1). All patients had a positive historical routine challenge test with intravenous DDAVP. For each participant, absolute and relative changes of FVIII and VWF activity levels 1 h after subcutaneous and intravenous DDAVP (both 0.3 mug/kg) were compared. Result(s): Eleven patients were included: Six with hemophilia A, three with VWD type 2M and two with VWD type 2A. Both intravenous and subcutaneous DDAVP increased FVIII and VWF activity levels in all patients. In hemophilia patients, intravenous and subcutaneous DDAVP increased FVIII levels by an average of 3.8-fold and 3.4-fold respectively. Peak FVIII activity levels at t = 1 ranged from 25-62 IU/ dl and 29-51 IU/dl. In VWD patients, intravenous and subcutaneous DDAVP was associated with a 11.4-fold and 5.1-fold mean increase in VWF activity levels respectively. Corresponding peak VWF activity levels ranged from 18-100 IU/dl and 28-74 IU/dl. No bleeding after vaccination was reported. Conclusion(s): Subcutaneous DDAVP appears to be an effective alternative for intravenous DDAVP. Moreover, like intranasal DDAVP, subcutaneous DDAVP allows the possibility of self-administration at home.
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In this article, Michael Earl, Director, Pharmaceutical Services, at Owen Mumford, discusses the importance of transitioning current healthcare models to embrace patient self-management and how advanced drug delivery device technologies, such as connectivity, can ease this burden on overstretched healthcare services.
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RATIONALE: Enrollment and retention of participants for any research study is challenging. The unpredictable nature of the ICU environment coupled with tenuous physiological status of patients can significantly thwart clinical trial accrual goals. The COVID-19 pandemic has pushed ICU census numbers to unprecedented levels with severely ill patients experiencing lengthy hospitalizations, delaying turn-over of beds. Anecdotal reports suggest challenges in achieving trial recruitment goals. The aims of this study were to describe the impact of the pandemic on a non-COVID-19 ICU clinical trial's screening and accrual of patients receiving mechanical ventilatory support. METHODS: A descriptive, retrospective design was used to address the study aims. Screening and accrual data were obtained from a Midwestern academic medical center in North America's parent clinical trial (R01HL130881). The primary aims of the efficacy trial are to test if patient selfadministration of dexmedetomidine (n = 190) reduces anxiety, delirium, ventilator days and ICU stay. A 3-step screening process prior to informed consent consists of (1) electronic health record (EHR) automated ICU census reports of mechanically ventilated patients, (2) in-depth review of the EHR for inclusion criteria, then (3) bedside assessment of grip strength to use a push-button medication delivery device and ability to follow commands. Descriptive statistics and Chi-square were used to compare screening and accrual data from a pre-pandemic timeframe (8/27/2018- 3/15/2020) to a pandemic timeframe (3/16/2020-12/31/2021). RESULTS: Of 91 eligible patients, 49 were accrued (53.8%) during the pre-pandemic timeframe. Patients were not accrued due to patient/LAR declination (78%) or primary medical team declination (22%). The three most frequent reasons for ineligibility were unarousable (25%), hypotension (11%) and not following commands (9%). While the pandemic timeframe had 30 fewer eligible patients, 40 of 61 (67%) were accrued. Patients were not accrued due to patient/LAR declination (87%) or medical team declination (13%), similar to pre-pandemic timeframe (p = 0.7). Pandemic timeframe had significantly more unarousable patients (32%, p < 0.0001) with fewer patients hypotensive (7%, p < 0.0001) or not following commands (7%, p = 0.01). Once COVID-19 infection was resolved, lengthy ventilator days, higher sedation levels, and prolonged immobility contributed to extremely weak grip strength, precluding trial eligibility. CONCLUSIONS: These retrospective data confirm this trial's enrollment was hampered by the COVID-19 pandemic due to fewer eligible, unarousable patients. Declinations from patients/LARs were similar during both timeframes. Inability to meet accrual milestones risks continued.
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Introduction: The covid19 pandemic has forced the health system to restructure to prevent contagion of our patients. In this context, the members of the Orthogeriatric Group of the Catalan Society of Geriatrics and Gerontology (SCGiG) created a document that collected all the considerations to take into account during the pandemic, based on the current guides and scientific societies, in order to perform a correct follow-up, enhance adherence and prevent future falls. Methods: A bibliographic review was performed, defining the key points in the care of the fractured patient through telemedicine (document is available at http://scgig.cat/docs/gt-orto-covid.pdf). Results: During hospital admission, antiosteoporotic treatment should be started, evaluating indications with the patient and family, to ensure adherence. Diet intake of calcium and vitamin D will be assessed. Discharge report includes evaluation of treatment and monitoring plan, to be useful for liaison nurse, rehabilitator and general practitioner. Six-monthly follow up is recommended for patients with comorbidities, polypharmacy, confusion, fall-risk, or parenteral anti-osteoporotic treatment. With denosumab or teriparatide, annual laboratory tests are recommended, with GFR <20, every six months, at home if possible. Bisphosphonates can be followed by the GP. Zoledronate is not recommended due to delayed administration after surgery, and possibility of transient flu-like simptoms. In the telematic follow-up visit, in patients undergoing zoledronic acid treatment, the new dose can be delayed for 6-12 months, without risk. Consider sequential treatment. Denosumab treatment cannot be delayed, so the patient and family will be trained in self-administration. Support materials from laboratories will be useful to patient and caregivers. Conclusion: Telemedicine is a good strategy for a follow-up, to avoid hospital contact, and starts on hospital admission. Patient and caregivers need access to new technologies and able to understand medical instructions.
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The current state of pulmonary vaccine delivery will be discussed in this review. The prospects for lung immunization using dry powder generation technologies and specialized medicinal formulations are discussed. In terms of vaccine durability and antigenicity, dry powder vaccine generation technologies may be advantageous. The non-invasive, reasonably safe, and low-cost nature of pulmonary delivery could help the public health vaccination significantly. The vaccines, which are all given intramuscularly, produce systemic antibodies in the blood but not antibodies in the pulmonary mucosal lining. Inhalation vaccines provide a number of potential benefits over injectable vaccines, including ease of delivery, and even self-administration. To create a dry powder inhalation formulation that is breathable and mediates robust transfection in the lung, a safe and effective mRNA delivery vector as well as a suitable particle engineering approach is needed.
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Objective: Describe characteristics of patients who self-inject denosumab and patterns of self-injection in France. Methods: PILOTE was a prospective observational study that evaluated persistence to denosumab over 24 months in France in postmenopausal women. Clinical information obtained through routine practice was recorded onto an eCRF, including the individual who injected subcutaneous denosumab (physician, nurse, patient, other). We conducted an ad hoc analysis of the patients in the study who self-injected denosumab. Results: In total, 478 patients were enrolled between June 2105 and February 2016. 27 patients self-injected denosumab at least once, with these patients distributed across multiple sites. Those who self-injected appeared slightly younger with longer duration of osteoporosis, and a higher proportion had a prior fracture and previous glucocorticoid and teriparatide treatment than the overall population (Table). Self-injected patients were also more likely to be living at home with family, have a University education, and be seen by a rheumatologist than a GP. Twelve patients self-injected from the beginning of the study, 15 self-injected after receiving injection from an HCP and 8 switched back to HCP injections after self-injection. Eleven of the 12 patients who self-injected from the beginning were persistent at 24 months. Six ADRs occurred in three self-injecting patients: one vertebral fracture, bone pain, muscle fatigue, myalgia, asthenia, pyelonephritis. Conclusion: Although numbers were small, self- administration of denosumab appeared feasible for women with postmenopausal osteoporosis and may be a valuable option, particularly in the context of the COVID-19 pandemic when office visits are restricted. (Table Presented).
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Background: Secondary antibody deficiency (SAD) is typical of hematological malignancies, such as chronic lymphocytic leukemia (CLL), multiple myeloma, and lymphoma or as a side effect of their treatment. Immunological defects are observed in 25-85% of CLL patients (pts), both naïve and previously treated, depending on duration, stage of disease, treatment, patient's age, and comorbidities. (Na et al., 2019;Patel et al., 2019;Zinzani et al., 2019;Reiser et al., 2017). In CLL pts, SAD increases the risk of infections, with overall higher morbidity and mortality Antibiotics administration and vaccinations are recommended as risk-reduction strategies. No real guidelines are available, but many indications warrant immunoglobulins replacement therapy (IgRT) in selected pts with low IgG (<5 g/l) or with more than three infective episodes per year despite antibiotic treatment and timely vaccination (Na et al., 2019;Reiser et al., 2017). No clear indications are available regarding the delivery method (intravenous or subcutaneous), dosage, frequency of administration, and duration of IgRT. Aims: The aim of this study is to assess the efficacy and the safety of SCIg on CLL patients in terms of infectious events, immune recovery and lymphocytes subset, impact on quality of life (QoL) on CLL pts in the Covid-19 era. Methods: Ten CLL pts with SAD have been treated with subcutaneous IgRT (SCIg) from October 2019 to December 2020. The median age and body weight of the pts were 66 years (56-88) and 68 kg (52-86) respectively. Five patients had comorbidities (hypertension, diabetes mellitus, and lung diseases) and 90% of them had an Eastern Cooperative Oncology Group (ECOG) performance 0-1. Five pts presented with unmutated IgVH and one of them also had 17p deletion. The median number of prior therapies was 2 (IBR, BR, Chl-antiCD20, FCR, in 5, 4, 4, 3 pts, respectively). At that time, 7 pts were on therapy (IBR, Ven, Alkylating Agent in 4, 1, 2 pts, respectively). None presented neutropenia. All pts underwent antibiotic prophylaxis with trimetroprin-cotimoxazole, sometimes associated with clarithromycin, and influenza vaccinations. The median baseline IgG level was 485mg/dl (118-817), with a median of 3 infection/year (1-5;pneumonia, UTI). Patients' characteristics are reported in Table 1. All pts received 10 g total dose hyaluronidase-free SCIg over a 1 h in double-needle subcutaneous infusion every 15 days for one year, independently from body weight. After the first dose, administered in a hospital setting to make the patient comfortable with their personal pump, the next doses were self-administered at home. The IgG level and CD4/CD8, CD19, and CD16/56 (natural killer, NK) lymphocytes subset were recorded at baseline and every three months during the observation period to monitor the immunological reconstitution as the therapy went on. Results: In our monocentric experience from October 2019 to December 2020 no patient experienced infectious events nor Covid-19 mediated interstitial pneumonia while on SCIg therapy. All patients tolerated well the therapy: nobody interrupted the treatment and only one patient presented a skin rash (grade 2). Both dosage and administration schedule have been stable over time. Dealing with humoral immunity, IgG levels arose from a median of 485 (118-817) mg/dl to a stable median value >600 mg/dl from 6 months onward. As expected, IgA and IgM values remained below normal levels. Dealing with cellular immunity, T-cells including CD4, CD8, and natural killer (NK, CD16/56) cells displayed a stable fashion until 6 months. On the other hand, the CD19 B cells values reflect both the disease status and the ongoing treatment effects. Results are reported in Table 1. Finally, we observed advantages on adherence to treatment, QoL, and costs, since pts did not need to go to the hospital with the help of a care-giver, rather they could comfortably get their SCIg at home without any assistance. Conclusion: SCIg administration in CLL pts with SAD is efficacious and safe as infectious prophylaxis, with hig er median IgG levels, thanks to both pharmacokinetic advantages and improved adherence to treatment. Especially in the Covid-19 era, the subcutaneous route is preferred to the intravenous one, because of the self-administration at home and the granted availability to the drug itself. Finally, subcutaneous administration gives advantages to the QoL and hospital expenditure.