Postoperative Serum Parathyroid Hormone Levels as a Predictor of Hypocalcemia in Patients Undergoing Total Thyroidectomy.

Postoperative hypocalcemia is a common complication of total thyroidectomy; the onset and severity of post-operative hypocalcemia is unpredictable. Various attempts have been made to identify predictors of hypocalcemia. There has been an increasing interest in serum levels of parathyroid hormone (PTH) as an early predictor of the development of hypocalcemia after total thyroidectomy. However, there is no consensus on the time intervals and cut-off levels of serum PTH to predict hypocalcemia. In this study, we intend to use serum PTH levels at 4th and 12th hour after total thyroidectomy to identify patients at risk of developing Postoperative hypocalcemia and to evaluate the role of PTH in predicting hypocalcemia. A Cross sectional analytical study conducted in 33 patients undergoing total/completion thyroidectomy from December 2018 to May 2020. Serum total calcium, Serum ionized calcium and Serum intact PTH levels were measured on three occasions (Preoperative and 4th and 12th hour Postoperative). Between both Postoperative levels of PTH, the one with better predictability of hypocalcemia was determined. Postoperative 4th hour PTH is a better predictor of transient hypocalcemia than Postoperative 12th hour PTH, as the association of the former with serum ionized calcium level was statistically highly significant with p value 0.005 and 0.021 respectively. Serum PTH determination after four hours of total thyroidectomy is a relatively better predictor of transient hypocalcemia, and can guide calcium supplementation for those at high risk in the Postoperative period. However, to determine the risk of hypocalcemia at the end of 1 month of follow-up, both the Postoperative 4th and post-operative 12th hour PTH have similar diagnostic accuracy.

Olfactory Dysfunction in COVID-19 Patients: Findings from a Tertiary Rural Centre.

Olfactory and/or taste dysfunction are potential neurological manifestations of coronavirus disease -2019 (COVID-19). The aim of the study was to document the prevalence of anosmia in COVID-19 positive patients and analyze the effect of various factors on the occurrence of these chemosensory dysfunction in the local population. Tertiary referral center. Prospective Study. 250 subjects who tested positive for SARS-CoV-2, by real-time polymerase chain reaction (RT-PCR) and admitted in Isolation ward were enrolled for the study. Data was collected from the subjects via oral questionnaire method, based on the AAO-HNS Anosmia Reporting Tool. Data was collected regarding the age, gender, olfactory or gustatory disturbances, history of recent travel or contact with a positive case, smoking, any associated symptoms, any co-morbid conditions and recovery time of sense of olfaction. Out of 250, 179 (71.6%) subjects were diagnosed with Olfactory dysfunction out of which majority were males, 105 (58.6%). Most of the patients were above 40 years of age (n = 184, 73.6%). Majority of the individuals (88 patients) had close contact with a positive case in recent past, followed by 67 patients who were health care workers, hence proving that risk of infection increases with exposure. Anosmia was present in 68.5% of all the 127 non-smokers. 66.4% had both olfactory as well as gustatory dysfunction whereas 18 patients (7.2%) were found to be totally asymptomatic. Mostly patients recovered their sense of smell within 1-2 weeks from the day of onset of anosmia. Presence of olfactory dysfunction of any degree with or without alteration in taste sensation should raise a suspicion of COVID-19 infection, especially when other classical signs are not present. In such conditions, swabs should be sent for confirmation by RT-PCR testing and till results are awaited, the individual should be shifted to quarantine facilities or advised strict self-isolation.

Nurse and Patient Perceptions and Preferences for Subcutaneous Autoinjectors for Inflammatory Joint or Bowel Disease: Findings from a European Survey.

INTRODUCTION: Imraldi™ is a biosimilar of the anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab and was recently approved in Europe for the treatment of various inflammatory conditions. Imraldi is administered via an autoinjector device that features distinct design attributes compared with other biologic TNF inhibitor autoinjectors, such as the Humira (adalimumab) Pen® and Enbrel® (etanercept) MyClic® Pen were developed by the relevant pharmaceutical companies. The aim of this study was to evaluate patients' and nurses' preferences for the Imraldi versus Humira or Enbrel MyClic autoinjectors in the UK and Germany. METHODS: Patients with inflammatory joint or bowel disease and nurses with experience in educating patients with these conditions on self-injection participated in two survey studies, the first comparing the Imraldi and Humira autoinjectors and the second comparing the Imraldi and Enbrel MyClic autoinjectors. RESULTS: Overall, 101 nurses (UK, n = 50; Germany, n = 51) and 151 patients (UK, n = 90; Germany, n = 61) participated in both studies. In the first study, 85% of nurses and 78% of patients preferred the Imraldi autoinjector over the Humira autoinjector (P < 0.001); in the second study, 86% of nurses and 79% of patients preferred the Imraldi autoinjector over the Enbrel MyClic autoinjector (P < 0.001). Top reasons for preferring the Imraldi autoinjector included ease of use, ease of grip, and its button-free initiation mechanism. Most nurses indicated they would recommend the Imraldi autoinjector over the Humira and Enbrel MyClic autoinjectors, and most patients indicated they would choose the Imraldi autoinjector over the Humira and Enbrel MyClic autoinjectors to continue treatment. CONCLUSION: Nurses and patients in the UK and Germany preferred the Imraldi autoinjector over both the Humira and Enbrel MyClic autoinjectors, which may be a consideration, along with other factors, for treatment decisions in the management of patients with inflammatory joint or bowel disease. FUNDING: Biogen International GmbH.

Patient Perceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: Findings from a Patient Survey in Europe.

INTRODUCTION: Benepali® was the first etanercept (Enbrel®) biosimilar to be approved in the European Union. Both Benepali and Enbrel are available as autoinjector devices. In a recent survey, nurses from France, Germany, Italy, Spain, and the United Kingdom (UK) reported that their patients with rheumatoid arthritis (RA) would prefer the Benepali autoinjector compared to the Enbrel MYCLIC autoinjector. To determine whether patients' perceptions were similar to those of the nurses, this survey evaluated patients' perceptions and preferences of the Benepali autoinjector versus the Enbrel MYCLIC autoinjector in the same five European countries. METHODS: Patients with RA using the Enbrel MYCLIC autoinjector participated in a 25-min, face-to-face questionnaire-interview. Patients were also shown an instructional video and device-handling leaflet, received a live demonstration on the Benepali autoinjector, and had access to both Benepali and Enbrel MYCLIC training autoinjectors. Patients rated the importance of ten autoinjector attributes on a seven-point scale (1 = not important at all; 7 = extremely important) and provided their autoinjector preferences based on specific attributes. Patients also gave their opinion on which autoinjector they would prefer to use for self-injection. RESULTS: Overall, 220 patients participated in the survey (France, n = 30; Germany, n = 65; Italy, n = 67; Spain, n = 12; UK, n = 46). 'Easy to operate the self-injection' was ranked as the most important attribute (mean score of 6.8), followed by 'easy to grip' (6.5), and 'intuitive/self-explaining usage' (6.3). Patients preferred the Benepali autoinjector, with the attribute of 'easier to operate' being a strong differentiator compared to the Enbrel MYCLIC autoinjector. Most patients (74%) reported that they would prefer to use the Benepali autoinjector over the Enbrel MYCLIC autoinjector. 'Easy to operate the self-injection' and 'button-free autoinjector' were key drivers when selecting an autoinjector. CONCLUSIONS: Patients in Europe reported a preference for the Benepali autoinjector compared to the Enbrel MYCLIC autoinjector. This finding is consistent with results from a recently reported nurse survey. FUNDING: Biogen.

Perceptions and Preferences of Two Etanercept Autoinjectors for Rheumatoid Arthritis: A New European Union-Approved Etanercept Biosimilar (Benepali®) Versus Etanercept (Enbrel®) - Findings from a Nurse Survey in Europe.

INTRODUCTION: Enbrel® (etanercept: manufactured by Immunex Corporation, Newbury Park, Thousand Oaks, CA 91320, USA) was the first biological disease-modifying anti-rheumatic drug approved for the treatment of rheumatoid arthritis (RA) in Europe. More recently, an etanercept biosimilar (Benepali®: manufactured by Biogen Inc, Cambridge, MA 02124, USA) was approved in the European Union. The perceptions and preferences of the Benepali autoinjector versus Enbrel MYCLIC autoinjector were evaluated by nurses from Europe. METHODS: The survey involved a 25-min face-to-face questionnaire-interview with nurses from France, Germany, Italy, Spain, and the UK, experienced in training patients on using the Enbrel MYCLIC autoinjector. Nurses viewed an instructional video and device-handling leaflet, received a live demonstration on the Benepali autoinjector and had access to both Benepali and Enbrel MYCLIC training autoinjectors. Nurses rated the importance of ten autoinjector attributes on a scale of 1-7 (1 = not important at all; 7 = extremely important) and provided their autoinjector preferences based on specific attributes. Nurses also gave their opinion on which autoinjector their patients with RA would prefer. RESULTS: A total of 149 nurses participated in this survey (France, n = 30; Germany, n = 40; Italy, n = 30; Spain, n = 19; UK, n = 30). 'Easy to operate the self-injection' was ranked as the most important attribute (mean score of 6.8), followed by 'easy to grip' (6.6) and 'intuitive/self-explaining usage' (6.6). Nurses preferred the Benepali autoinjector, with attributes of 'easier to operate' and 'more intuitive to use' being strong differentiators compared with the Enbrel MYCLIC autoinjector. Most nurses (86%) reported that their patients would prefer the Benepali autoinjector over the Enbrel MYCLIC autoinjector. 'Easy to operate the self-injection' and 'button-free autoinjector' were key drivers when selecting an autoinjector. CONCLUSION: Based on these survey results, nurses in Europe reported a preference for the Benepali autoinjector compared with the Enbrel MYCLIC autoinjector for the majority of attributes assessed. In particular, attributes of 'easy to operate' and 'more intuitive/self-explaining to use' were highly rated for the Benepali autoinjector, which may allow easy handling of the autoinjector. FUNDING: Biogen International GmBH.

Autoinjector preference in multiple sclerosis and the role of nurses in treatment decisions: results from an international survey in Europe and the USA.

PURPOSE: This international survey recorded the opinions of multiple sclerosis (MS) nurses about their role in treatment decision making and about the importance of different attributes of autoinjectors used to deliver first-line parenteral therapy. METHODS: The survey involved 52 MS nurses in different practice settings in France, Germany, Italy, the UK, and the USA. Nurses described their role in patient education and in treatment decision making. They also rated the importance of nine prespecified attributes of autoinjectors and stated their preference, both overall and by attribute, for one of two autoinjectors used to deliver interferon ß-1b (ExtaviPro® 30G and Betacomfort®). Nurses' preferences were compared with those previously collected from patients using an identical questionnaire. RESULTS: There were pronounced differences between practice settings and between countries in the opinions of MS nurses about their influence on treatment decision making. Nurses considered themselves instrumental in helping patients decide between treatment options offered by neurologists. Of the nine autoinjector attributes, nurses rated "reliable to use" as most important, followed by attributes associated with convenience ("easy to operate," "ergonomic shape," "reach" [of injection sites], and "one-handed injection"). Nurses' and patients' rankings of attributes were closely aligned. For the nine attributes, 74%-98% of nurses preferred ExtaviPro® 30G to Betacomfort®, 94% preferring ExtaviPro® 30G overall. Nurses showed a greater preference than patients for ExtaviPro® 30G with respect to "easy to operate" (92% vs 78%), "intuitive to use" (98% vs 78%), and "attractive design" (98% vs 83%; P<0.05, all), but preference rates were otherwise similar across the two groups. The most common reasons in both groups for preferring ExtaviPro® 30G to Betacomfort® were "easy to use" and "ergonomic shape." CONCLUSION: MS nurses play a key role in patient guidance and education. Their preferences for ExtaviPro® 30G likely reflect their understanding of the challenges patients face when self-administering treatment.

Autoinjectors for administration of interferon beta-1b in multiple sclerosis: patient preferences and the ExtaviPro™ 30G and Betacomfort® devices.

BACKGROUND: The ExtaviPro™ 30G autoinjector has been developed for self-administration of interferon beta-1b (Extavia®), which is used as a first-line, parenteral, disease-modifying therapy in multiple sclerosis (MS). The aim of this survey was to investigate patients' perceptions of the importance of different general attributes of autoinjectors, and patient preferences when comparing the ExtaviPro™ 30G and Betacomfort® autoinjectors. METHOD: The survey was conducted in France, Germany, Italy, and the USA in patients with relapsing-remitting MS who had been using an autoinjector for at least 1 year. Participants examined the ExtaviPro™ 30G and Betacomfort® devices, viewed fact sheets, and watched a video of these autoinjectors in use, then scored nine prespecified attributes of autoinjectors in terms of importance on a scale of 1-7 (1 = not at all important; 7 = extremely important). They then indicated which device they preferred, both overall and by individual attribute. RESULTS: Among the 201 participants who completed the survey, being reliable to use was considered the most important general attribute of autoinjectors, followed by attributes associated with convenience (ease of operation, one-handed injection, ease of reach of injection sites, ergonomic shape). For each of the nine attributes, a significantly higher proportion of participants (74%-94% by attribute; P < 0.05 for each) preferred ExtaviPro™ 30G to the Betacomfort® autoinjector, and 173 (86%) participants indicated that they preferred ExtaviPro™ 30G overall (P < 0.05). CONCLUSION: The results of this survey suggest that patients with MS rate reliability and convenience as the most important general attributes of autoinjectors, and are more likely to prefer ExtaviPro™ 30G to the Betacomfort® autoinjector for routine self-administration of interferon beta-1b.