Restriction of non-opioid analgesics sold over-the-counter in Denmark:A national study of impact on poisonings

Objective: Self-poisoning with non-opioid analgesics presents a growing challenge to health care providers. We aimed to assess the impact of an 18-year age restriction of OTC sales and a pack size restriction of non-opioid analgesics sold OTC in pharmacies on hospital-treated poisonings and poisoning severity measured using biomarkers. Methods: We applied a before and after design using interrupted time series analysis. Data on all poisonings recorded as hospital admissions were obtained during 2002-2015 and biochemical parameters from laboratory databases during 2011-2015, both covering the entire Danish population. Results: The age restriction was followed by a 17% level reduction in admissions for non-opioid analgesic poisoning among young people age 10-17 years (RR 0.830; 95% CI 0.697-0.988; p < 0.036). After the pack size restriction, an instant level reduction of 18.5% (RR 0.815; 95% CI 0.729-0.912; p < 0.001) was observed for the entire population. A 27% decrease in the number of poisonings with alanine transaminase levels (ALT) ≥ 210 U/L was observed (RR 0.734; 95% CI 0.579-0.931; p = 0.011) followed by 40% decrease in biomarkers indicative of liver failure (RR 0.597; 95% CI 0.421-0.847; p = 0.004). We also observed similar reductions for other poisonings such as psychotropics. Limitations: Although declines in poisonings were observed after implementation of means restrictive measures, a causal link cannot be inferred. Conclusion: Age and pack size restriction were assiociated with a reduction in the numbers of poisonings. This was also observed for pharmaceutical poisonings in general, which might suggest a non-specific or spill-over effect.This work was funded by a scholarship at University of Copenhagen, Department of Medical and Health Science

An Internet-based emotion regulation intervention versus no intervention for non-suicidal self-injury in adolescents:a statistical analysis plan for a feasibility randomised clinical trial

BACKGROUND: Non-suicidal self-injury (NSSI) has a lifetime prevalence of 17% in adolescents in the general population and up to 74% in adolescents with psychiatric disorders. NSSI is one of the most important predictors of later suicidal behaviour and death by suicide. The TEENS feasibility trial was initiated to assess the feasibility and safety of Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA) as an add-on to treatment as usual in 13–17-year-old patients with NSSI referred to the Child and Adolescent Mental Health Services. METHODS: The TEENS feasibility trial is a randomised clinical trial with a parallel-group design. The trial intervention is an 11-week online therapy which is tested as an add-on to treatment as usual versus treatment as usual. The primary feasibility outcomes are the fraction of participants who (1) completed 12 weeks of follow-up interview or assessment, (2) consented to inclusion and randomisation out of all eligible participants, and (3) were compliant with the experimental intervention, assessed as completion of at least six out of eleven modules in the programme. Since this is a feasibility trial, we did not predefine a required sample size. The exploratory clinical outcome, the frequency of NSSI episodes, assessed using Deliberate Self-Harm Inventory – Youth version (DSHI-Y), at the end of intervention, is planned to be the future primary outcome in a larger pragmatic definitive randomised clinical trial. After completion of the feasibility trial, blinded data will be analysed by two independent statisticians blinded to the intervention, where ‘A’ and ‘B’ refer to the two groups. A third party will compare these reports, and discrepancies will be discussed. The statistical report with the analyses chosen for the manuscript is being tracked using a version control system, and both statistical reports will be published as a supplementary material. Based on the final statistical report, two blinded conclusions will be drawn by the steering group. DISCUSSION: We present a pre-defined statistical analysis plan for the TEENS feasibility trial, which limits bias, p-hacking, data-driven interpretations. This statistical analysis plan is accompanied by a pre-programmed version-controlled statistical report with simulated data, which increases transparency and reproducibility. TRIAL REGISTRATION: ClinicalTrials.govNCT04243603. Registered on 28 January 2020 SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-021-05406-2

Incidence Rates of Deliberate Self-Harm in Denmark 1994–2011:A Nationwide Register Study

Abstract. Background: The validity and reliability of suicide statistics have been questioned and few nationwide studies of deliberate self-harm have been presented. Aim: To calculate rates of deliberate self-harm in Denmark in order to investigate trends and assess the reliability of hospital records. Method: A register study based on all individuals recorded with an episode of deliberate self-harm or probable deliberate self-harm in nationwide registers during 1994–2011. Results: A substantial difference in the rates of deliberate self-harm and probable deliberate self-harm was noted for both genders. The average incidence rate of deliberate self-harm for women and men was 130.7 (95% CI = 129.6–131.8) per 100,000 and 86.9 (95% CI = 86.0–87.8) per 100,000, respectively. The rates of deliberate self-harm for women increased from 137.6 (95% CI = 132.9–142.3) per 100,000 in 1994 to 152.7 (95% CI = 147.8–157.5) in 2011. For a subgroup of younger women aged 15–24 years, an almost threefold increase was observed, IRR = 2.5 (95% CI = 2.4–2.7). The most frequently used method was self-poisoning. Conclusion: The rates of deliberate self-harm and probable deliberate self-harm differed significantly. An increased incidence of deliberate self-harm among young Danish women was observed, despite detection bias. An improved registration procedure of suicidal behavior is needed