Background Coronavirus disease 2019 (COVID‐19) pandemic has resulted in unprecedented pressure on healthcare systems and led to widespread utilization of telemedicine or telehealth services. Combined with teleclinics, using drive‐up fingerstick International normalized ratio (INR) testing was recommended to decrease exposure risk of anticoagulation patients. Objective To evaluate the impact of transitioning from clinic‐based anticoagulation management services to drive‐up and phone‐based services during COVID‐19 pandemic in Qatar. Methods The study comprised of two components: a retrospective cohort study of all eligible patients who attended anticoagulation clinic over 1‐year period (6 months before and 6 months after service transition) and a cross‐sectional survey of eligible patients who agreed to provide data about their satisfaction with the new service. Monitoring parameters, clinical outcomes, and resource utilization related to warfarin therapy were compared before and after service transition. Patients' experience was explored through a structured survey. Results There was no statistically significant difference between clinic‐based and phone‐based anticoagulation services in mean time and number of visits within therapeutic range (P = .67; P = .06 respectively); mean number of extreme subtherapeutic and supratherapeutic INR values (P = .32 and P = .34, respectively); incidence of thromboembolic complications and warfarin related hospitalization. There was one reported bleeding and one emergency visit (0.9%) in the phone‐based group vs none in the clinic‐based group. Frequency of INR testing and compliance to attending clinics appointments declined significantly (P = .002; P = .001, respectively). Overall, patients were highly satisfied with the new service. The majority of patients found it better (51.6%) or just as good as the traditional service (44.5%). Patients who preferred the new service were significantly younger than their counterparts (P = .005). Conclusion The service of drive‐up INR testing and phone‐based consultations was shown to be comparable to traditional anticoagulation service, a finding that supports maintaining such services as part of the new normal after the pandemic is over.
Background: Cancer is the second leading cause of death globally. Up to 86% of advanced cancer patients experience significant pain, while 10-20% live in chronic pain. Besides, increasing prescription of opioids resulted in 33,000 deaths in the US in 2015. Both reduce patients’ functional status and quality of life. While cancer survival rates are increasing, therapeutic options for chronic opioid refractory pain are still limited. Esketamine is the s-enantiomer of ketamine, with superior analgesic effect and less psychotomimetic side effects. Intranasal esketamine was approved by the FDA for treatment-resistant depression. However, its use in chronic cancer pain has never been tested. Therefore, we propose a phase II, randomized, placebo-controlled trial to evaluate the efficacy and safety of intranasal esketamine in chronic opioid refractory cancer pain. Methods and analysis: We will recruit 120 subjects with chronic opioid refractory pain, defined as pain lasting more than 3 months despite optimal therapy with high dose opioids (>60 mg morphine equivalent dose/day) and optimal adjuvant therapy. Subjects will be randomized into two groups: intranasal esketamine (56mg) and placebo. Treatment will be administered twice a week for four consecutive weeks. The primary outcome is defined as reduction in the Numeric Pain Rating Scale (NPRS) after first application. Secondary outcomes include NPRS reduction after four weeks, the number of daily morphine rescue doses, functional status and satisfaction, and depression. Conclusion: This study may extend therapeutic options in patients with chronic pain, thus improving their quality of life and reducing opioid use. Trial registration: Clinical Trials.gov, NCT04666623. Registered on 14 December 2020
fatal consequences. Missing dependent and independent controls regarding concentration and identity pose a risk for patient safety. Purpose We developed a concept for a two-stage quality control of the infusion solutions. Drug identity and concentration can be checked onsite after preparation using a combined UVand Raman spectrometer (UV-Raman). This is complemented by an independent method using liquid chromatography coupled to UV detection (HPLC-UV). Material and methods Methods for the analysis of seven cytostatic drugs and two monoclonal antibodies were developed and validated on an i-QCRx UV-Raman system (B and W Tek Europe GmbH, Lübeck, Germany) and on an Agilent 1200 series HPLC-UV system (Agilent Technologies, Waldbronn, Germany). Sample transport and preparation were evaluated to ensure valid results. In a pilot study we analysed samples from different pharmacies in both systems. Results Method development and validation were successful for the investigated compounds in both systems. HPLC-UV is more sensitive than UV-Raman. However, due to the content of the preparations, real samples had to be diluted before applying HPLC-UV analysis. Sensitivity of the UV-Raman spectrometer fits to the required concentration range without further dilution. All methods showed reproducible results, UV-Raman varied by 0.44% in a repeated analysis (n=3) of 5-fluorouracil, while HPLC-UV varied by 0.14%. Results of the investigated samples were also equivalent. In a sample containing paclitaxel with a target concentration of 0.72 mg/mL we determined 0.73 mg/mL (101%) using UV-Raman and 0.69 mg/mL (96%) using HPLC-UV, for example. Conclusion UV-Raman and HPLC-UV are suitable for determining the content of patient-individual preparations, both with individual assets and drawbacks. The study showed that the two-stage control concept is appropriate to ensure a highquality level for patient-individual preparations.
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