A study protocol for a European, mixed methods, prospective, cohort study of the effectiveness of naloxone administration by community members, in reversing opioid overdose: NalPORS.

BACKGROUND: Worldwide, opioid use causes more than 100,000 overdose deaths annually. Naloxone has proven efficacy in reversing opioid overdoses and is approved as an emergency antidote to opioid overdose. Take home naloxone (THN) programmes have been introduced to provide 'community members', who are likely to observe opioid overdoses, with naloxone kits and train them to recognise an overdose and administer naloxone. The acceptability and feasibility of THN programmes has been demonstrated, but the real-life effectiveness of naloxone administration by community members is not known. In recent years, the approval of several concentrated naloxone nasal-spray formulations (in addition to injectable formulations, eg.prenoxad) potentially increases acceptability and scope for wider provision. This study aims to determine the effectiveness of THN (all formulations) in real-world conditions. METHODS: A European, multi-country, prospective cohort study, to assess the use of THN by community members to reverse opioid overdoses in a six-month, follow-up period. Participants provided with THN from participating harm reduction and drug treatment sites will be recruited to the study and followed-up for six months. We are particularly interested in the experiences of community members who have been provided with THN and have witnessed an opioid overdose. All participants who witness an opioid overdose during the six-month period (target approx. 600) will be asked to take part in a structured interview about this event. Of these, 60 will be invited to participate in a qualitative interview. A Post Authorisation Efficacy Study (PAES) for the concentrated nasal naloxone, Nyxoid, has been integrated into the study design. DISCUSSION: There are many challenges involved in evaluating the real-life effectiveness of THN. It is not possible to use a randomised trial design, recruitment of community members provided with THN will depend upon recruitment sites distributing THN kits, and the type of THN received by participants will depend on regulations and on local clinical and policy decision-makers. Following up this population, some of whom may be itinerant, over the 6-month study period will be challenging, but we plan to maintain contact with participants through regular text message reminders and staff contact. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05072249. Date of Registration: 8.10.2021.

A cross-sectional study on oral health-care habits and oral-health-related quality-of-life in marginalized persons in Copenhagen.

OBJECTIVE: The aim of this cross-sectional study was to investigate the oral-health-related quality-of-life (OHRQoL) and oral health-care habits in a population of marginalized persons in Copenhagen. MATERIALS AND METHODS: Patients attending a dental clinic for marginalized persons filled in the 14-item version of the oral-health-impact profile (OHIP-14) regarding their OHRQoL and a questionnaire on their oral health-care habits. Age, gender, smoking habits, need for general and oral health-care, and living conditions were further registered. RESULTS: Of the 212 participants, 72% had not visited a dental clinic within the past two years and in 68% of the cases, the last dental visit was related to dental treatment. Tooth brushing at least once a day was reported by 93%. The mean OHIP-14 score in the participants was 24.9 (SD: 13.6). The most frequent problems were pain, chewing difficulties, being self-conscious, tense, and embarrassed as well as affected life. The mean OHIP-14 score was significantly higher in participants in need of general health-care (29.5, SD: 12.2) than in participants not in need of general health-care (22.8, SD: 13.9). The same applied to participants referred for dental treatment (26.1, SD: 12.7) compared to participants not being referred (20.2, SD: 15.9). CONCLUSIONS: The OHRQoL is poor in the population with pain, chewing difficulties and aesthetic issues as the most prominent problems. The participants had low and treatment-oriented use of the dental care system. This indicates a high need for dental care in the population with a focus on including them in the dental care system.

Take-Home Naloxone Kits: Attitudes and Likelihood-Of-Use Outcomes from a European Survey of Potential Overdose Witnesses.

BACKGROUND: Injectable naloxone is already provided as take-home naloxone (THN), and new concentrated intranasal naloxone is now being introduced in Europe. Despite evidence of the effectiveness and cost-effectiveness of THN, little is known about the attitudes of key target populations: people who use opioids (PWUO), family/friends, and staff. We examined the acceptability of different naloxone devices (ampoule, prefilled syringe, and concentrated nasal spray) across 5 European countries. OBJECTIVES: The aim of this study was to compare THN target groups (PWUO vs. family/friends vs. staff) in their past rates of witnessed overdose and THN administration (as indicators of future use), current THN device preference, and THN carriage on the day of survey. METHOD: Cross-sectional survey of respondents (age ≥18) in addiction treatment, harm reduction, and recovery services in Denmark, England, Estonia, Norway, and Scotland. A purpose-developed questionnaire (59 items) was administered in the local language electronically or in a pen-and-paper format. RESULTS: Among n = 725 participants, 458 were PWUO (63.2%), 214 staff (29.5%), and 53 (7.3%) family members. The groups differed significantly in their likelihood-of-future THN use (p < 0.001): PWUO had the highest rate of previously witnessing overdoses (352; 77.7%), and staff members reported the highest past naloxone use (62; 30.1%). Across all groups, most respondents (503; 72.4%) perceived the nasal spray device to be the easiest to use. Most reported willingness to use the spray in an overdose emergency (508; 73.5%), followed by the prefilled syringe (457; 66.2%) and ampoules (64; 38.2%). Average THN carriage was 18.6%, ranging from 17.4% (PWUO) to 29.6% (family members). CONCLUSION: Respondents considered the concentrated naloxone nasal spray the easiest device to use. Still, most expressed willingness to use the nasal spray as well as the prefilled syringe in an overdose emergency. Carriage rates were generally low, with fewer than 1 in 5 respondents carrying their THN kit on the day of the survey.

One opioid user saving another: the first study of an opioid overdose-reversal and naloxone distribution program addressing hard-to-reach drug scenes in Denmark.

BACKGROUND: Overdose education and naloxone distribution programs decrease opioid overdose deaths. However, no studies of such programs have been carried out in Denmark. The aim of this study was to evaluate the feasibility and the effect of a broader "training-the-trainers" model in low-threshold settings after participation in the "Danish Save Lives" [SL] program. METHODS: Between May 2013 and November 2015, 552 participants from four municipalities took part in the SL program. The program is built on the train-the-trainers model where a central trainer trains others (trainers), who in turn train others (helpers). Participants were 30 police officers (5%), 188 people who use opioids (34%), 23 significant others (4%), and 217 social workers (39%). Ninety-four participants could not be classified (17%). At follow-up, participants were interviewed to determine the number and outcomes of opioid overdoses. Logistic regression was used to assess predictors of treating an overdose. RESULTS: In all, 37 (7%) participants had intervened in 45 opioid overdose events (two trainers and 35 helpers). Detailed descriptions of the overdose event were available from 32 follow-up interviews (70%). In 16 cases, the person who intervened was already present at the site when the overdose occurred, and in 17 cases, the overdose victim recovered without complications. All overdose victims survived except one. People who used opioids were more likely to have treated an overdose than other participants (adjusted odds ratio [AOR] = 8.50, p = 0.001), and the likelihood of treating and overdose declined over time AOR = 0.37 (0.13, 0.93), p = 0.034). CONCLUSIONS: Prevention programs that target people who use opioids are more likely to be effective than programs that target professionals, especially in high-risk settings that can be hard for paramedics to reach. A future goal is to explore how prevention programs can be adapted to new user groups. TRIAL REGISTRATION: The Danish Data Protection Agency, 2015-57-0002, Aarhus University, 2016-051-000001, 184, retrospectively registered.

Whole genome sequencing reveals two genetically distinct MRSA outbreaks among people who inject drugs and homeless people in Copenhagen.

Whole genome sequencing (WGS) has greatly improved the detection of methicillin-resistant Staphylococcus aureus (MRSA) transmission between people. We describe the transmission of two unique MRSA clones among homeless people in Copenhagen using WGS and core genome MLST (cgMLST). In 2014, an accumulation of MRSA bacteremia cases among homeless people admitted to our hospital was recognized, all having the rare MRSA spa t5147/ST88. The European Typology of Homelessness and Housing Exclusion (ETHOS) categories revealed that people who inject drugs (PWID) frequently visiting the milieu but living in private accommodation accounted for most cases. Hoping to terminate the transmission, 161 homeless people were MRSA screened in 2015, but no additional cases were found. From 2009 to 2018, 60 patients with genomically related t5147/ST88 isolates were found, of these 70% were confirmed to come from the homeless setting and 17% had bacteremia. From 2017 to 2020, cgMLST revealed a smaller MRSA outbreak including 13 PWID with a completely different clone, t1476/ST8, of which 15% had bacteremia. Our study confirms that WGS and cgMLST is excellent to reveal MRSA outbreaks. The ETHOS categorization can be useful to find the primary source of spread in the homeless community.

A rapid assessment of take-home naloxone provision during COVID-19 in Europe.

BACKGROUND: In March 2020, the World Health Organization declared COVID-19 a global pandemic. In the following weeks, most European countries implemented national lockdowns to mitigate viral spread. Services for people who use drugs had to quickly revise their operating procedures to rearrange service provision while adhering to lockdown requirements. Given the scarcity of literature published on overdose prevention during COVID-19 in Europe, we aimed to examine how these changes to service provision affected take-home naloxone (THN) programmes and naloxone availability across Europe. METHODS: Between November 2020 and January 2021, we conducted a rapid assessment with country experts from European countries that provide THN. We sent country experts a template to report monthly THN distribution data (January 1, 2019-October 31, 2020) and a structured 6-item survey for completion. RESULTS: Responses were received from 14 of the 15 European countries with THN provision of which 11 participated in the rapid assessment: Austria, Denmark, England, Estonia, Lithuania, Northern Ireland, Norway, Scotland, Spain (Catalonia only), Sweden, and Wales. All reported reduced organisational capacity during COVID-19, and some put into place a range of novel approaches to manage the restrictions on face-to-face service provision. In six countries, the introduction of programme innovation occurred alongside the publication of government guidelines recommending increased THN provision during COVID-19. Eight of the eleven participating countries managed to maintain 2019-level monthly THN distribution rates or even increase provision during the pandemic. CONCLUSION: Through programme innovation supported by public guidelines, many European THN programmes managed to ensure stable or even increased THN provision during the pandemic, despite social distancing and stay-at-home orders affecting client mobility.

Healthcare Cost Reductions after Moving into a Wet Nursing Home Stay-A Case Series.

Serious alcohol dependence is associated with high healthcare costs, especially when patients have chronic problems with alcohol, dementia and exhibit externalizing behavior. One option is to offer a wet nursing home for seriously ill patients for whom abstinence from alcohol is not a feasible option. In this case series, we present the healthcare costs 18 months before moving into a "wet nursing home", and in the first 18 months of their stay, for three cases, one with low needs of care, one with medium needs, and one with high needs. Results: for all three patients, hospital costs were reduced by between 83.7 and 97.9% for patients with dementia, externalizing behavior, and chronic alcohol problems, a wet nursing home can produce substantial cost reductions in other parts of the healthcare sector.

The use of the ADHD self-rating scale (ASRS-6) in the homeless: psychometric properties, alcohol use, and self-nurse agreement.

BACKGROUND: Attention deficit/hyperactivity disorder (ADHD) is prevalent in homeless populations, but no studies have assessed the psychometric properties of assessment instruments for this population. METHODS: Self-other agreement on the ADHD Self-Rating Scale 6 was studied using a cohort of admissions to an outreach clinic for the homeless (n = 72). Alcohol use was assessed with the fast alcohol screening test. Other drug use was assessed by interview. RESULTS: For the six-item ASRS-6, the self-nurse correlation was .63 (p < .001). Discriminant correlations were low. Higher ASRS-6 scores as rated by both nurse and self-report were associated with illicit drug use but not alcohol problems. Concordance was lower at higher levels of alcohol problems (p < .05) CONCLUSION: The observations of experienced nurses converge well with self-reported symptoms of ADHD. Further research is needed to assess the relative contribution of clinical observation and self-report in assessing homeless patients.

Biological markers of problem drinking in homeless patients.

OBJECTIVE: In the search for optimal biomarkers of excessive drinking, a central limitation has been the lack of sensitivity of measures. Many patients have apparently normal values of liver markers despite a considerable alcohol intake. This study aimed to test a novel combined indicator of alcohol drinking. MATERIAL AND METHODS: Concentrations of carbohydrate-deficient transferrin (%CDT), gamma glutamyl transferase (gammaGT), aspartate aminotransferase (ASAT), and mean corpuscular volume (MCV), together with a combined index of the %CDT and gammaGT, the Antilla Index (AI), were studied in 104 homeless patients with (n = 87) or without (n = 24) problem drinking according to the Fast Alcohol Screening Test. RESULTS: Concentrations of all markers were significantly higher in the alcoholic patients than in other homeless patients. The best agreement between liver markers and self-reported status was found between the combined %CDT and gammaGT index (kappa = 0.61, p < 0.001, sensitivity = 63%, specificity = 94%). CONCLUSIONS: The combined AI is a relatively efficient measure of current drinking in homeless populations.

The CAGE as a measure of hazardous drinking in the homeless.

The aim of this study was to test the validity of the CAGE questions as a measure of severe drinking in subjects at drop-in centers for the homeless, using biological markers of acute liver reaction to alcohol as the "gold standard." A sample of homeless men and women in Copenhagen were invited to participate in a study of health problems. Subjects were interviewed and blood samples were taken and screened for indicators of liver dysfunction (gamma-glutamyltransferase [gammaGT], mean corpuscular volume [MCV], alanine aminotransferase [ALAT], and alkaline phosphatase [Alpase]), and hepatitis C [HCV]. Scores on CAGE correlated strongly with years of heavy drinking (rho = 0.43, p < 0.001), and while years of drinking did not correlate with biomarkers after controlling for multiple hypothesis testing, CAGE correlated with gammaGT, Alpase and ALAT, but not MCV. The correlations held even among those without HCV, but subjects with HCV + and CAGE > 1 had quite extreme values on liver markers. Findings suggested that the CAGE was able to identify homeless drinkers whose drinking was significantly associated with increases in biomarkers associated with heavy drinking.