Evaluation of a national programme to improve shared decision-making skills among junior medical doctors in Denmark: a mixed methods study of satisfaction, usefulness, and dissemination of learning outcomes in clinical practice.

BACKGROUND: Shared decision-making (SDM) is a cornerstone in patient-centred care and there has been an increase in programmes aiming to improve clinicians' abilities to engage in it. However, the evidence for such programmes' effectiveness on clinicians' use of SDM in clinical practice is sparse. The SDM Ambassador course, developed and facilitated by the Danish Association of Junior Doctors in Denmark (Junior Doctors Denmark) is a Danish SDM training programme for junior medical doctors (JMDs). This study aims to evaluate the SDM Ambassador course, with a focus on satisfaction, usefulness, and dissemination of learning outcomes in clinical practice. METHODS: This is a mixed methods study, consisting of an online survey followed by semi-structured interviews. The participants were JMDs who had trained to be SDM ambassadors between May 2016 and September 2020 (n=185). The ambassadors were invited to participate in the survey and 112 ambassadors completed it, corresponding to a response rate of 61%. Descriptive statistics and χ2-tests were conducted. Subsequently, purposive sampling was used to identify 10 ambassadors for interviews. The interviews were transcribed, encoded, and subsequently analysed thematically. Finally, the quantitative and qualitative results were integrated. RESULTS: Overall, the ambassadors were satisfied with their learning outcomes and experienced a greater capacity to unfold the perspectives of their patients. A majority (79%) reported that they had used SDM in their clinical practice with patients, and 59% had disseminated SDM to their colleagues. The usefulness and dissemination of learning outcomes in the clinic were shaped by the ambassadors' perceptions of their moderate professional experience as junior doctors, and constrained by structural and cultural conditions in the context of their clinical practice. CONCLUSIONS: Despite overall satisfaction with their learning outcomes, several ambassadors experienced conditions constraining the translation of their learning outcomes into clinical practice. To improve the efficacy of the training programme, continuous refresher courses should be added, while enhanced support at organisational and political levels is necessary for SDM to become an integral feature of the clinical encounter. TRIAL REGISTRATION: Not applicable.

Study rationale and design of the EANITIATE study (EmpAgliflozin compared to NPH Insulin for sTeroId diAbeTEs) - a randomized, controlled, multicenter trial of safety and efficacy of treatment with empagliflozin compared with NPH-insulin in patients with newly onset diabetes following initiation of glucocorticoid treatment.

BACKGROUND: A well-known metabolic side effect from treatment with glucocorticoids is glucocorticoid-induced diabetes mellitus (GIDM). Guidelines on the management of GIDM in hospitalized patients (in the non-critical care setting), recommend initiation of insulin therapy. The scientific basis and evidence for superiority of insulin therapy over other glucose lowering therapies is however poor and associated with episodes of both hypo- and hyperglycaemia. There is an unmet need for an easier, safe and convenient therapy for glucocorticoid-induced diabetes. METHODS: EANITIATE is a Danish, open, prospective, multicenter, randomized (1:1), parallel group study in patients with new-onset diabetes following treatment with glucocorticoids (> 20 mg equivalent prednisolone dose/day) with blinded endpoint evaluation (PROBE design). Included patients are randomized to either a Sodium-Glucose-Cotransporter 2 (SGLT2) inhibitor or neutral protamin Hagedorn (NPH) insulin and followed for 30 days. Blinded continuous glucose monitoring (CGM) will provide data for the primary endpoint (mean daily blood glucose) and on glucose fluctuations in the two treatment arms. Secondary endpoints are patient related outcomes, hypoglycaemia, means and measures of variation for all values and for time specific glucose values. This is a non-inferiority study with the intent to demonstrate that treatment with empagliflozin is not inferior to treatment with NPH insulin when it comes to glycemic control and side effects. DISCUSSION: This novel approach to management of glucocorticoid-induced hyperglycemia has not been tested before and if SGLT2 inhibition with empaglifozin compared to NPH-insulin is a safe, effective and resource sparing treatment for GIDM, it has the potential to improve the situation for affected patients and have health economic benefits. TRIAL REGISTRATION: www.clinicaltrialsregister.eu no.: 2018-002640-82. Prospectively registered November 20th. 2018. Date of first patient enrolled: June 4th. 2019. This protocol article is based on the EANITATE protocol version 1.3, dated 29. January 2018.

The influence on survival of glucocorticoid induced diabetes in cancer patients with metastatic spinal cord compression.

BACKGROUND AND PURPOSE: The influence of glucocorticoid induced hyperglycemia on survival in patients with metastatic spinal cord compression (MSCC) is unknown. MATERIALS AND METHODS: In a prospective, observational cohort study 131 patients with MSCC referred to radiotherapy, 30 Gray (Gy) in 10 fractions, and treated with ≥100 mg prednisolone a day were followed with daily blood glucose measurements during radiotherapy. RESULTS: During follow-up a total of 56 patients 43% (95% CI = 35-52%) presented plasma glucose values diagnostic of diabetes. Sixteen patients who developed diabetes were treated with insulin, 12% (95% CI = [6%; 18%]) of the total population. The patients developing diabetes with need for insulin therapy during glucocorticoid therapy had a significantly increased mortality compared to those with normal glucose metabolism and with diabetes without need for therapy, hazard ratio = 2.1 (95% CI = 1.08-4.09, p = 0.0285). DISCUSSION: To our knowledge this is the first prospective study to describe the influence of glucocorticoid induced diabetes on survival in patients with MSCC from different primary tumors. CONCLUSIONS: The results indicate that development of diabetes during high-dose glucocorticoid therapy needing insulin treatment in patients with MSCC from different primary tumors is associated with reduced survival.

[Glucocorticoid-induced diabetes and risk factors during high-dose therapy].

This review describes the cumulative incidence (CI) and risk factors of glucocorticoid (GC)-induced diabetes in patients commencing high-dose GC therapy: ≥ 30 mg prednisolone/day. Finally, methods of screening are discussed. In 13 studies, the CI of GC-induced diabetes ranges 12-65%, but with the current diagnostic criteria the CI is assessed to be 30-50%. Risk factors may include high age and high levels of BMI and glycated haemoglobin, respectively, before GC therapy. It is important to acknowledge, that hyperglycaemia in GC therapy is more prevalent postprandially, and screening should be planned accordingly.

Glucocorticoid-induced diabetes in patients with metastatic spinal cord compression.

BACKGROUND: The risk of developing diabetes mellitus (DM) during treatment with high-dose glucocorticoids is unknown and monitoring of glucose is random in many settings. OBJECTIVE: To determine incidence of and risk factors for induction of DM during high-dose glucocorticoid therapy of metastatic spinal cord compression (MSCC) in patients referred to radiotherapy. Furthermore, to describe the time course of development of DM. SUBJECTS AND METHODS: 140 patients were recruited (131 were included in the analysis) with MSCC receiving high-dose glucocorticoid ≥100 mg prednisolone per day were included in a prospective, observational cohort study. The primary endpoint was development of DM defined by two or more plasma glucose values ≥11.1 mmol/L. Plasma glucose was monitored on a daily basis for 12 days during radiotherapy. RESULTS: Fifty-six of the patients (43%; 95% CI 35-52%) were diagnosed with DM based on plasma glucose measurements during the study period. Sixteen patients, 12% (95% CI 6-18%), were treated with insulin. At multivariate analysis, only high baseline HbA1c predicted the development of insulin-treated DM. An HbA1c-value <39 mmol/mol was associated with a negative predictive value of 96% for not developing DM needing treatment with insulin. The diagnosis of diabetes with need for insulin treatment was made within 7 days in 14 of the 16 (88%; 95% CI 72-100%) patients. CONCLUSION: The risk of developing DM during treatment with high-dose glucocorticoids in patients with MSCC referred to radiotherapy is high in the first treatment week. Only referral HbA1c predicts the development of DM.

Early incidence of glucocorticoid-induced diabetes in patients with brain tumors: a retrospective study of the first 7 days of treatment.

BACKGROUND: Hyperglycemia or diabetes is a well-known side effect of treatment with glucocorticoids. In patients with brain tumors, glucocorticoids are widely used to treat symptoms of peritumoral edema. We conducted a retrospective study of patients with suspected brain tumor to determine the incidence of and risk factors for glucocorticoid-induced diabetes. METHODS: This was a retrospective study of patients referred with suspected brain tumor to a neurological department, using data from a clinical database, electronic medical records, the laboratory system, and the pathology information bank. . Nondiabetic patients with a neuroimaging-verified brain tumor treated with high-dose glucocorticoid and monitored with glucose measurements were included in the study. RESULTS: Among 809 patients referred with suspected brain tumor, 171 were eligible for the study. Thirty-eight (22%) patients developed glucocorticoid-induced diabetes, defined as 2 glucose measurements ≥200 mg/dl (11.1 mmol/l) within the first week of treatment, and 4 of the patients were treated with insulin. The majority of patients with glucocorticoid-induced diabetes were identified on days 2, 3, and 4, and glucose levels were highest in the afternoon and evening. We were not able to identify any risk factors for glucocorticoid-induced diabetes and glucocorticoid-induced diabetes had no influence on survival in our cohort. CONCLUSIONS: Glucocorticoid-induced diabetes is frequent in the first 7 days of treatment in patients with brain tumors. The results emphasize the need for screening for glucocorticoid-induced diabetes in this group of patients to avoid comorbidity expected to arise from hyperglycemia.

Prevalence of delirium among patients at a cancer ward: Clinical risk factors and prediction by bedside cognitive tests.

Background Delirium is a frequent psychiatric complication to cancer, but rarely recognized by oncologists. Aims 1. To estimate the prevalence of delirium among inpatients admitted at an oncological cancer ward 2. To investigate whether simple clinical factors predict delirium 3. To examine the value of cognitive testing in the assessment of delirium. Methods On five different days, we interviewed and assessed patients admitted to a Danish cancer ward. The World Health Organization International Classification of Diseases Version 10, WHO ICD-10 Diagnostic System and the Confusion Assessment Method (CAM) were used for diagnostic categorization. Clinical information was gathered from medical records and all patients were tested with Mini Cognitive Test, The Clock Drawing Test, and the Digit Span Test. Results 81 cancer patients were assessed and 33% were diagnosed with delirium. All delirious participants were CAM positive. Poor performance on the cognitive tests was associated with delirium. Medical records describing CNS metastases, benzodiazepine or morphine treatment were associated with delirium. Conclusions Delirium is prevalent among cancer inpatients. The Mini Cognitive Test, The Clock Drawing Test, and the Digit Span Test can be used as screening tools for delirium among inpatients with cancer, but even in synergy, they lack specificity. Combining cognitive testing and attention to nurses' records might improve detection, yet further studies are needed to create a more detailed patient profile for the detection of delirium.