Study protocol: a randomised controlled trial on the clinical effects of levothyroxine treatment for subclinical hypothyroidism in people aged 80 years and over

Background: Subclinical hypothyroidism is common in older people and its contribution to health and disease needs to be elucidated further. Observational and clinical trial data on the clinical effects of subclinical hypothyroidism in persons aged 80 years and over is inconclusive, with some studies suggesting harm and some suggesting benefits, translating into equipoise whether levothyroxine therapy provides clinical benefits. This manuscript describes the study protocol for the Institute for Evidence-Based Medicine in Old Age (IEMO) 80-plus thyroid trial to generate the necessary evidence base. Methods: The IEMO 80-plus thyroid trial was explicitly designed as an ancillary experiment to the Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism randomised placebo controlled Trial (TRUST) with a near identical protocol and shared research infrastructure. Outcomes will be presented separately for the IEMO and TRUST 80-plus groups, as well as a pre-planned combined analysis of the 145 participants included in the IEMO trial and the 146 participants from the TRUST thyroid trial aged 80 years and over. The IEMO 80-plus thyroid trial is a multi-centre randomised double-blind placebo-controlled parallel group trial of levothyroxine treatment in community-dwelling participants aged 80 years and over with persistent subclinical hypothyroidism (TSH ≥4.6 and ≤ 19.9 mU/L and fT4 within laboratory reference ranges). Participants are randomised to levothyroxine 25 or 50 micrograms daily or matching placebo with dose titrations according to TSH levels, for a minimum follow-up of one and a maximum of three years. Primary study endpoints: hypothyroid physical symptoms and tiredness on the thyroid-related quality of life patient-reported outcome (ThyPRO) at one year. Secondary endpoints: generic quality of life, executive cognitive function, handgrip strength, functional ability, blood pressure, weight, body mass index, and mortality. Adverse events will be recorded with specific interest on cardiovascular endpoints such as atrial fibrillation and heart failure. Discussion: The combined analysis of participants in the IEMO 80-plus thyroid trial with the participants aged over 80 in the TRUST trial will provide the largest experimental evidence base on multimodal effects of levothyroxine treatment in 80-plus persons to date

Study protocol: A randomised controlled trial on the clinical effects of levothyroxine treatment for subclinical hypothyroidism in people aged 80 years and over

Background: Subclinical hypothyroidism is common in older people and its contribution to health and disease needs to be elucidated further. Observational and clinical trial data on the clinical effects of subclinical hypothyroidism in persons aged 80 years and over is inconclusive, with some studies suggesting harm and some suggesting benefits, translating into equipoise whether levothyroxine therapy provides clinical benefits. This manuscript describes the study protocol for the Institute for Evidence-Based Medicine in Old Age (IEMO) 80-plus thyroid trial to generate the necessary evidence base. Methods: The IEMO 80-plus thyroid trial was explicitly designed as an ancillary experiment to the Thyroid hormone Replacement for Untreated older adults with Subclinical hypothyroidism randomised placebo controlled Trial (TRUST) with a ne

Telemedicine as an Untapped Opportunity for Parkinson's Nurses Training in Personalized Care Approaches

(1) Background: Parkinson nurses (PN) take over important functions in the telemedical care of person's with Parkinson's disease (PwPs). This requires special competencies that have so far been largely unexplored. The aim of the article is to identify competencies of PN operating in a personalized care model. (2) Methods: This study employed a qualitative approach. Based on the competency framework for telenursing, PN were asked about their competencies using a qualitative online survey. (3) Results: The results show that PN need competencies on a personal and organizational level, as well as in the relationship with PwPs. PN have developed these skills through professional exchange, training, and personal experience. In addition, both hindering and beneficial factors for the development of competencies could be identified. (4) Conclusions: Competency development for telemedical care is complex and must be designed and promoted in a targeted manner

Telemedicine as an Untapped Opportunity for Parkinson's Nurses Training in Personalized Care Approaches

(1) Background: Parkinson nurses (PN) take over important functions in the telemedical care of person’s with Parkinson’s disease (PwPs). This requires special competencies that have so far been largely unexplored. The aim of the article is to identify competencies of PN operating in a personalized care model. (2) Methods: This study employed a qualitative approach. Based on the competency framework for telenursing, PN were asked about their competencies using a qualitative online survey. (3) Results: The results show that PN need competencies on a personal and organizational level, as well as in the relationship with PwPs. PN have developed these skills through professional exchange, training, and personal experience. In addition, both hindering and beneficial factors for the development of competencies could be identified. (4) Conclusions: Competency development for telemedical care is complex and must be designed and promoted in a targeted manner

Characterization of a novel influenza A virus hemagglutinin subtype (H16) obtained from black-headed gulls.

In wild aquatic birds and poultry around the world, influenza A viruses carrying 15 antigenic subtypes of hemagglutinin (HA) and 9 antigenic subtypes of neuraminidase (NA) have been described. Here we describe a previously unidentified antigenic subtype of HA (H16), detected in viruses circulating in black-headed gulls in Sweden. In agreement with established criteria for the definition of antigenic subtypes, hemagglutination inhibition assays and immunodiffusion assays failed to detect specific reactivity between H16 and the previously described subtypes H1 to H15. Genetically, H16 HA was found to be distantly related to H13 HA, a subtype also detected exclusively in shorebirds, and the amino acid composition of the putative receptor-binding site of H13 and H16 HAs was found to be distinct from that in HA subtypes circulating in ducks and geese. The H16 viruses contained NA genes that were similar to those of other Eurasian shorebirds but genetically distinct from N3 genes detected in other birds and geographical locations. The European gull viruses were further distinguishable fro