Odense Municipality

OBJECTIVES:The Bacillus Calmette-Guerin (BCG) vaccine has beneficial effects on the immune system, which may lead to non-specific protection against non-tuberculous infections and increase the response to subsequent vaccinations. Seasonal influenza vaccination is used to protect senior citizens against influenza, but the serological response to the inactivated influenza vaccine (IIV) decreases in the elderly due to immunosenescence. The aim of this study was to test the capacity of BCG to boost the specific immune response to IIV and explore the effect of BCG on the innate immune system and health of senior citizens. METHODS:A randomised controlled trial with a nested immunological study including 273 Danish citizens >65 years. Participants were randomised into four equally sized groups combining BCG with IIV in different sequences compared with IIV alone. The primary outcome was change in influenza antibody hemagglutination inhibition (HI) titre four weeks after vaccination. Secondary outcomes were infection rate during six months follow-up, and association between influenza antibody titre and infection rate. In subgroup analyses, we explored the effect of BCG on lymphocyte populations seven days after IIV and on cytokine production after stimulation of mononuclear cells in vitro. RESULTS:Four weeks after influenza vaccination, the mean fold change in HI titre over all serotypes was 2.3-2.5 with no significant differences between the treatment groups. Seroconversion rate was comparable between treatment groups, and in strata of age and sex. There was no difference in the rate of infection between the groups and there was no association with influenza antibody level. We found no difference in distribution of lymphocytes. Combining BCG with IIV had modest impact on in vitro cytokine production compared with IIV alone. CONCLUSION:BCG vaccination did not increase serological response to seasonal influenza vaccination or reduce the incidence of infection in this population of Danish senior citizens. TRIAL REGISTRATION:EU Clinical Trials Register (EudraCT number 2019-002781-12). SUMMARY:In this randomised clinical trial of Danish senior citizens, BCG vaccination did not influence serological response to influenza vaccination or reduce the risk of infection compared with placebo. There was no clear indication of induction of trained immunity.

Introduction and Objective: To determine whether impaired awareness of hypoglycemia (IAH) is associated with depression, anxiety, diabetes distress and fear of hypoglycemia in people with T1D or insulin-treated T2D. Methods: 276 T1D and 321 insulin-treated T2D participants in the Hypo-METRICS study completed questionnaires to assess for depression (PHQ-9), anxiety (GAD-7), diabetes distress (PAID) and fear of hypoglycemia (HFS-II; worry and behavior). IAH was defined as a Gold score of ≥4. Logistic regression analyses were performed to assess the cross-sectional relationships between mental health scores and IAH. Results: IAH was associated with significantly higher depression and anxiety in both groups (for depression OR 1.44 [1.26-1.64; p <0.001] in T1D, OR 1.15 [1.04-1.27; p <0.001] in T2D, for anxiety OR 1.44 [1.25-1.66; p <0.001] in T1D, OR 1.16 [1.03-1.3; p 0.013] in T2D). IAH was also associated with more worries about hypoglycemia in T1D (OR 1.29 [1.2-1.39]; p <0.001) and T2D (OR 1.27 [1.19-1.36]; p <0.001), and more diabetes distress in T1D (OR 1.35 [1.27-1.43]; p <0.001) and less diabetes distress in T2D (OR 0.92 [0.88-0.97]; p 0.002). Conclusion: IAH is significantly associated with higher levels of depression, anxiety and fear of hypoglycemia in T1D and insulin-treated T2D. Interventions that address mental health, as well as hypoglycemia risk, may be more effective at restoring awareness. A.M. McCarthy: None. P. Divilly: None. F. Pouwer: Research Support; Novo Nordisk, Eli Lilly and Company. P. Choudhary: Speaker's Bureau; Abbott. Advisory Panel; Dexcom, Inc. Consultant; Insulet Corporation. Advisory Panel; Ypsomed AG, embecta, Sanofi. Speaker's Bureau; Lilly Diabetes, Medtronic. Advisory Panel; Roche Diabetes Care. Consultant; Cambridge Mechatronics.

INTRODUCTION:Equal access to healthcare is a fundamental principle in the fully tax-financed Danish healthcare system. This study reveals whether this system lives up to the principle of equal access when it comes to the rehabilitation of patients who have major lower extremity amputations.METHODS:With the aim of exploring possible inequality in rehabilitation for patients having major lower extremity amputation in Denmark, a nationwide electronic survey was conducted in the autumn of 2020, which included all hospitals and municipalities in Denmark.RESULTS:Eighty six percent of hospitals (n = 19) and 97% (n = 95) of municipalities responded. Of the 32% (n = 6) of hospitals and 78% (n = 74) of municipalities that provided prosthesis rehabilitation, the majority (hospitals 50% /municipalities 91%) provided prostheses for <10 patients in 2019, and 36% reported having competencies at only a general level among physiotherapists performing prosthetic training. Psychosocial rehabilitation modalities were lacking overall.CONCLUSIONS:This national study documents pronounced geographic inequality in access to qualified rehabilitation services for the relatively few patients undergoing lower extremity amputations in Denmark. The decentralised organisation of amputation rehabilitation makes it difficult to build and maintain specialist competencies among healthcare professionals. Inconsistent availability of psychosocial rehabilitation modalities of all kinds found in this study points to a need for action particularly among patients not in prosthetic rehabilitation where palliative needs should also be considered.