Low-dose naltrexone for treatment of pain in patients with fibromyalgia: a randomized, double-blind, placebo-controlled, crossover study.

Introduction: Fibromyalgia (FM) is a chronic fluctuating, nociplastic pain condition. Naltrexone is a µ-opioid-receptor antagonist; preliminary studies have indicated a pain-relieving effect of low-dose naltrexone (LDN) in patients with FM. The impetus for studying LDN is the assumption of analgesic efficacy and thus reduction of adverse effects seen from conventional pharmacotherapy. Objectives: First, to examine if LDN is associated with analgesic efficacy compared with control in the treatment of patients with FM. Second, to ascertain the analgesic efficacy of LDN in an experimental pain model in patients with FM evaluating the competence of the descending inhibitory pathways compared with controls. Third, to examine the pharmacokinetics of LDN. Methods: The study used a randomized, double-blind, placebo-controlled, crossover design and had a 3-phase setup. The first phase included baseline assessment and a treatment period (days -3 to 21), the second phase a washout period (days 22-32), and the third phase a baseline assessment followed by a treatment period (days 33-56). Treatment was with either LDN 4.5 mg or an inactive placebo given orally once daily. The primary outcomes were Fibromyalgia Impact Questionnaire revised (FIQR) scores and summed pain intensity ratings (SPIR). Results: Fifty-eight patients with FM were randomized. The median difference (IQR) for FIQR scores between LDN and placebo treatment was -1.65 (18.55; effect size = 0.15; P = 0.3). The median difference for SPIR scores was -0.33 (6.33; effect size = 0.13; P = 0.4). Conclusion: Outcome data did not indicate any clinically relevant analgesic efficacy of the LDN treatment in patients with FM.

[Rater bias in postgraduate medical education]. / Bedømmerbias i speciallægeuddannelsen.

In-training assessment is a cornerstone in outcome based postgraduate medical education. When assessing the trainee the trainer should be aware of potential pitfalls and biases and how to avoid these. This paper summarises assessor biases and pitfalls and gives recommendations on how to avoid these.

[Implementation of a national training assessment programme in anaesthesiology]. / Implementering af nationalt kompetenceprogram i anaestesiologi.

INTRODUCTION: In 2004, outcome-based education and in-training assessment was introduced by a reform of postgraduate medical education in Denmark. An assessment programme covering the introductory year of anaesthesiology was constructed. The purpose of this study was to explore to which degree this programme was implemented in daily practice in the clinical departments and whether the recommended assessment protocol was followed. MATERIALS AND METHODS: A questionnaire was distributed to 26 departments and 38 trainees. RESULTS: The response rate for both groups exceeded 90%. Individual learning plans were prepared by (2/3) of the trainees according to both trainees and departments. The various methods in the assessment programme were implemented to a high degree. The use of structured clinical observations was reported by more than 70% of both groups. Global assessments were applied in more than 70% according to both groups. Fifty percent of the trainees and 70% of the departments reported that these were used in accordance with recommendations. The trainees profited from preparing the written assignments, but only half of them found that they were used in accordance with recommendations. In contrast, more than 90% of the departments reported that the assignments were implemented according to recommendations. Practical completion of in-training assessment was considered difficult by 67% of the departments and 30% of trainees. The workload was the primary difficulty reported. CONCLUSION: In conclusion, the in-training assessment programme of the introductory year of anaesthesia has been implemented to a high degree and the assessment protocol is used according to recommendations.

[Integrated clinical educational project]. / Integreret klinisk uddannelse.

This paper describes a two-year postgraduate educational project involving three different clinical departments. The educational climate was enhanced through different interventions, such as training tutors, more effective supervision, improved daily routines, and repeated educational seminars. Evaluation was made by questionnaires involving all physicians once a year. In addition to the repetition of interventions, the importance of support from leaders and general engagement in the process of changing the educational climate is underlined.