A deprescribing programme aimed to optimise blood glucose-lowering medication in older people with type 2 diabetes mellitus, the OMED2-study: the study protocol for a randomised controlled trial.

BACKGROUND: Older patients with type 2 diabetes mellitus (T2D) have an increased risk of hypoglycaemic episodes when using sulphonylureas or insulin. In the Netherlands, guidelines exist for reducing glucose-lowering medication in older patients. However, evidence is lacking that a medication reduction in older patients can be safely pursued. Here, we will examine if promoting the deprescribing of insulin/sulphonylureas with a deprescribing programme (DPP) in general practice affects T2D-complications in older overtreated patients. METHODS: We will perform a 1:1 cluster randomised controlled trial in 86 general practices in the Netherlands. The DPP will consist of education sessions with general practitioners and practice nurses about reducing glucose-lowering medication in older patients (≥ 70 years). Topics of the sessions include the necessity of deprescribing, tools to initiate deprescribing and strategies to discuss deprescribing with patients (shared decision making). The DPP further includes a support programme with practice visits. The study will employ a selection tool to identify possibly overtreated older patients from the electronic medical records of the general practitioner. Eligibility for enrolment in the study will be based on HbA1c targets indicated by the Dutch guidelines, which depend on age, diabetes duration, presence of frailty, and life expectancy. The control group will provide usual care. We aim to include 406 patients. The follow-up period will be 2 years. For the primary outcome, the effect of the DPP on T2D-complications will be assessed by counting the cumulative incidence of events related to under- and overtreatment in T2D as registered in the electronic medical records. We shall perform an intention-to-treat analysis and an analysis including only patients for whom deprescribing was initiated. The implementation of the DPP in general practice will be evaluated quantitatively and qualitatively using the Extended Normalisation Process Theory (ENPT) and the Reach, Efficacy - Adoption, Implementation and Maintenance (RE-AIM) model. Other secondary outcomes include quality of life, cognitive functioning, events related to overtreatment or undertreatment, biomarkers of health, amount of blood glucose-lowering medication prescriptions, and cost-effectiveness. DISCUSSION: This study will provide insight into the safety and feasibility of a programme aimed at deprescribing sulphonylureas/insulin in older people with T2D who are treated in general practice. TRIAL REGISTRATION: ISRCTN Registry, ISRCTN50008265 , registered 09 March, 2023.

Implementation of Patient Reported Outcomes in Outpatient Palliative Care: From Paper to Computer.

BACKGROUND: This quality improvement project aimed to transition completion of Edmonton Symptom Assessment System (ESAS) at our supportive care clinic from paper to electronic format. MEASURES: Proportion of patients who completed electronic ESAS (eESAS). INTERVENTION: Starting July 2018, patients could complete eESAS 24h before check-in (eESAS-before), eESAS after check-in (eESAS-after) or on paper (pESAS). OUTCOMES: A total of 6631 cancer patients had 25,767 clinic visits between July 13, 2018 and November 5, 2021. The ESAS completion rate was 100%. eESAS uptake gradually increased over time, first reaching ≥75% eESAS completion in 5/2019 (eESAS-after 61.9%; eESAS-before 14.0%; pESAS 24.1%). We observed a sharp uptake in eESAS-before since adoption of telehealth during the pandemic (May 2020) and the ≥75% eESAS target was consistently achieved from November 2020 onwards (eESAS-after 0.6%; eESAS-before 76.7%; pESAS 22.7%). In an anonymous survey, we identified several modifiable barriers to implementing eESAS. CONCLUSIONS: Transition to eESAS was a gradual process and was catalyzed by the pandemic.

Diagnosis, management and impact of painful diabetic peripheral neuropathy: A patient survey in four European countries.

AIMS: The aim of this study was to assess patient perspectives and experiences of the impact of neuropathic pain, painful diabetic neuropathy (pDPN) diagnosis and treatment, and the patient-healthcare professional (HCP) relationship. METHODS: We conducted a quantitative online survey in Germany, the Netherlands, Spain, and the UK among adults with diabetes who responded "yes" to at least four of ten questions of in the Douleur Neuropathique en 4 Questions (DN4) questionnaire. RESULTS: Of 3626 respondents, 576 met the eligibility criteria. Daily pain was rated as moderate or severe by 79 % of respondents. Most participants reported a negative impact of their pain on sleep (74 %), mood (71 %), exercise (69 %), concentration (64 %) and daily activities (62 %), and 75 % of those in employment had missed work because of their pain in the past year. Overall, 22 % of respondents avoided discussing pain with their HCP, 50 % had not received formal pDPN diagnosis, and 56 % had not used prescribed pain medications. Although two-thirds (67 %) of respondents reported feeling satisfied or very satisfied with treatment, 82 % of these patients still experienced daily moderate or severe pain. CONCLUSIONS: Neuropathic pain in people with diabetes affects daily life and remains underdiagnosed and undertreated in clinical practice.

Measuring symptom burden in patients with cancer during a pandemic: the MD Anderson symptom inventory for COVID-19 (MDASI-COVID).

BACKGROUND: Symptom expression in SARS-CoV-2 infection (COVID-19) may affect patients already symptomatic with cancer. Patient-reported outcomes (PROs) can describe symptom burden during the acute and postacute stages of COVID-19 and support risk stratification for levels of care. At the start of the COVID-19 pandemic, our purpose was to rapidly develop, launch through an electronic patient portal, and provide initial validation for a PRO measure of COVID-19 symptom burden in patients with cancer. METHODS: We conducted a CDC/WHO web-based scan for COVID-19 symptoms and a relevance review of symptoms by an expert panel of clinicians treating cancer patients with COVID-19 to create a provisional MD Anderson Symptom Inventory for COVID-19 (MDASI-COVID). English-speaking adults with cancer who tested positive for COVID-19 participated in the psychometric testing phase. Patients completed longitudinal assessments of the MDASI-COVID and the EuroQOL 5 Dimensions 5 Levels (EQ-5D-5L) utility index and visual analog scale, which were presented through an electronic health record patient portal. To test the validity of the MDASI-COVID to distinguish between known groups of patients, we hypothesized that patients hospitalized, including having a hospitalization extended, for COVID-19 versus those not hospitalized would experience higher symptom burden. Correlation of mean symptom severity and interference scores with relevant EQ-5D-5L scores tested concurrent validity. The reliability of the MDASI-COVID was evaluated by calculating Cronbach alpha coefficients and test-retest reliability was evaluated by calculating Pearson correlation coefficients between the initial assessment and a second assessment no more than 14 days later. RESULTS: The web-based scan found 31 COVID-19-related symptoms; rankings of a 14-clinician expert panel reduced this list to 11 COVID-specific items to be added to the core MDASI. Time from literature scan start in March 2020 to instrument launch in May 2020 was 2 months. Psychometric analysis established the MDASI-COVID's reliability, known-group validity, and concurrent validity. CONCLUSIONS: We were able to rapidly develop and electronically launch a PRO measure of COVID-19 symptom burden in patients with cancer. Additional research is needed to confirm the content domain and predictive validity of the MDASI-COVID and define the symptom burden trajectory of COVID-19.

Femoral Vein Cannulation in the Treatment of Osteomyelitis.

OBJECTIVE: The main objective was to investigate the feasibil- ity of using the femoral vein for long-term venous access. This was accomplished in the course of treating osteomyelitis patients, using a combination of long-term (6 weeks), outpatient, intravenous (IV) an- tibiotics administered through a femoral central line. This was com- bined subsequently with the use of hyperbaric oxygen (HBO) therapy. Using the femoral vein for central venous access means there is no risk of creating an iatrogenic pneumothorax, which would prohibit the subsequent use of HBO therapy. In addition, the propitious nature of the groin skin flora, Propionibacteriaceae, seems less inclined to par- ticipate in biofilm production, the root cause of central line infections. METHODS: The femoral central lines were all inserted in the operating room (OR) and handled like a regular outpatient surgery with a me- ticulous skin prep completed by experienced OR nurses. Experienced technicians assisted with the surgery. After insertion, the lines were then specially secured to prevent sliding. Vancomycin was adminis- tered preoperatively. RESULTS: Surprisingly, femoral lines placed in this way remained free of infection for up to 70 days. Eight patients with Wagner stage 2 ulcers and underlying osteomyelitis were treated with a course of 6 weeks of vancomycin, followed by HBO therapy. A cure rate of 75% was achieved. CONCLUSION: Femoral vein cannulation for antibi- otic administration is safe and effective in treating patients with osteo- myelitis. The lines should be placed in the OR with the help of skilled personnel. Femoral cannulation avoids the risk of pneumothorax, and the lines can be used for up to 70 days. By avoiding pneumothorax, the patients remain candidates for HBO therapy.