The Danish Pain Research Biobank (DANPAIN-Biobank): a collection of blood, cerebrospinal fluid, and clinical data for the study of neuroimmune and glia-related biomarkers of chronic pain.

Background: Chronic pain is a major health problem worldwide but the limited knowledge of its underlying pathophysiology impairs the opportunities for diagnostics and treatment. Biomarkers of chronic pain are greatly needed to understand the disease and develop new targets for interventions and drug treatments, and potentially introduce more precise diagnostic procedures. Much evidence points to a neuroimmune pathology for many chronic pain conditions and that important neuroimmune biomarkers exist in the cerebrospinal fluid (CSF) of patients with chronic pain. Systematic collection of CSF in large cohorts of chronic pain patients and healthy volunteers has proven difficult, however. We established the Danish Pain Research Biobank (DANPAIN-Biobank) with the aim of studying potential neuroimmune and glia-related biomarkers of chronic pain. In this paper, we describe the methods and the study population of the DANPAIN-Biobank. Methods: In this cross-sectional study, we included (I) participants with high-impact (HI) chronic pain from a tertiary, interdisciplinary pain center; (II) participants with osteoarthritic pain scheduled for arthroplasty surgery of the hip or knee at a regional hospital; and (III) pain-free volunteers. All participants completed a questionnaire assessing pain, functional impairment, anxiety, depression, and insomnia before samples of blood and CSF were extracted. Quantitative sensory tests were performed on participants with HI chronic pain and pain-free volunteers, and postoperative outcome scores were available on participants with osteoarthritic pain. Results: Of the 352 participants included, 201 had HI chronic pain (of which 71% had chronic widespread pain), 81 had chronic osteoarthritic pain, and 70 were pain-free volunteers. Samples were handled uniformly, and CSF samples were frozen within 30 minutes. Conclusions: We describe the content of the DANPAIN-Biobank, which is unique in terms of the number of participants (including pain-free volunteers), extensive clinical data, and uniformity in sample handling. We believe it presents a promising new platform for the study of neuroimmune and glia-related biomarkers of chronic pain.

Long-term Weight Loss in a Primary Care-Anchored eHealth Lifestyle Coaching Program: Randomized Controlled Trial.

BACKGROUND: Long-term weight loss in people living with obesity can reduce the risk and progression of noncommunicable diseases. Observational studies suggest that digital coaching can lead to long-term weight loss. OBJECTIVE: We investigated whether an eHealth lifestyle coaching program for people living with obesity with or without type 2 diabetes led to significant, long-term (12-month) weight loss compared to usual care. METHODS: In a randomized controlled trial that took place in 50 municipalities in Denmark, 340 people living with obesity with or without type 2 diabetes were enrolled from April 16, 2018, to April 1, 2019, and randomized via an automated computer algorithm to an intervention (n=200) or a control (n=140) group. Patients were recruited via their general practitioners, the Danish diabetes organization, and social media. The digital coaching intervention consisted of an initial 1-hour face-to-face motivational interview followed by digital coaching using behavioral change techniques enabled by individual live monitoring. The primary outcome was change in body weight from baseline to 12 months. RESULTS: Data were assessed for 200 participants, including 127 from the intervention group and 73 from the control group, who completed 12 months of follow-up. After 12 months, mean body weight and BMI were significantly reduced in both groups but significantly more so in the intervention group than the control group (-4.5 kg, 95% CI -5.6 to -3.4 vs -1.5 kg, 95% CI -2.7 to -0.2, respectively; P<.001; and -1.5 kg/m2, 95% CI -1.9 to -1.2 vs -0.5 kg/m2, 95% CI -0.9 to -0.1, respectively; P<.001). Hemoglobin A1c was significantly reduced in both the intervention (-6.0 mmol/mol, 95% CI -7.7 to -4.3) and control (-4.9 mmol/mol, 95% CI -7.4 to -2.4) groups, without a significant group difference (all P>.46). CONCLUSIONS: Compared to usual care, digital lifestyle coaching can induce significant weight loss for people living with obesity, both with and without type 2 diabetes, after 12 months. TRIAL REGISTRATION: ClinicalTrials.gov NCT03788915; https://clinicaltrials.gov/ct2/show/NCT03788915.

Reversing Type 2 Diabetes in a Primary Care-Anchored eHealth Lifestyle Coaching Programme in Denmark: A Randomised Controlled Trial.

The goal of this trial was to investigate whether an eHealth lifestyle coaching programme led to significant weight loss and decreased Haemoglobin A1c (HbA1c) in patients with type 2 diabetes. In an RCT, 170 patients were enrolled from 2018 to 2019 for intervention or control. Inclusion criteria were diagnosed with type 2 diabetes, BMI 30−45 kg/m2, and aged 18−70 years. Exclusion criteria were lacks internet access, pregnant or planning a pregnancy, or has a serious disease. Primary and secondary outcomes were a reduction in body weight and HbA1c. At six months, 75 (75%) patients in the intervention group and 53 (76%) patients in the control group remained in the trial. The mean body weight loss was 4.2 kg (95% CI, −5.49; −2.98) in the intervention group and 1.5 kg (95% CI, −2.57; −0.48) in the control group (p = 0.005). In the intervention group, 24 out of 62 patients with elevated HbA1c at baseline (39%) had a normalized HbA1c < 6.5% at six months, compared to 8 out of 40 patients with elevated HbA1c at baseline (20%) in the control group (p = 0.047). The eHealth lifestyle coaching programme can lead to significant weight loss and decreased HbA1c among patients with type 2 diabetes, compared to standard care.

Risk of delirium and impaired neurological outcome associated with delay in neurorehabilitation after acquired brain injury.

INTRODUCTION Brain injury from haemorrhage, trauma, aneurysm and stroke is characterised by high mortality and impaired neurological outcome. In the OUTREACH study, the authors wanted to assess patient care from admission to intensive neuro rehabilitation to discharge. We hypothesised that early rehabilitation was beneficial to neurological outcome. METHODS 180-day mortality and modified Rankin Scale (mRS) were primary end points. Secondary end points included length of stay, Glasgow Coma Scale (GCS) on admission, ventilator days, Simplified Acute Physiology Score (SAPS II/III) and serious adverse events. RESULTS Sixty-seven patients were included. Mortality at 180 days was 17.91% and the median mRS score was four. Length of stay was 20.89 ± 12.33 days. GCS at admittance was 13 (3-15). The average SAPS II/III score was 55.72 ± 20.03. Twenty-eight patients suffered from serious adverse events. In all, 47 patients waited for transfer to another facility for an average of 7.77 ± 6.08 days. For mRS, the linear model indicated a negative effect of waiting time (effect = -0.056 (95% confidence interval (CI): -0.117-0.004); p = 0.07). Risk of delirium was significantly affected by waiting time; an additional day of waiting increased the risk of delirium by 13.4% (odds ratio = 1.134 (95% CI: 1.028-1.252); p = 0.01). CONCLUSIONS In this study, mortality and neurological outcome were comparable with those reported in similar studies. Waiting for transfer to another facility due to capacity significantly impairs neurological outcome and increases delirium. FUNDING none. TRIAL REGISTRATION not relevant.