PrEP facilitators and barriers in substance use bridge clinics for women who engage in sex work and who use drugs.

BACKGROUND: Women who engage in sex work and use drugs (WSWUD) experience disproportionate HIV risks. Substance use treatment bridge clinics offer an opportunity to increase HIV pre-exposure prophylaxis (PrEP) delivery to WSWUD, but research on best practices is lacking. Therefore, we explored facilitators and barriers to PrEP across the PrEP care continuum in these settings. METHODS: Bridge clinic and affiliated harm reduction health service providers and WSWUD from Boston were recruited using passive and active outreach between December 2021 and August 2022. Participants were invited to take part in semi-structured phone or in-person interviews to explore HIV prevention and PrEP care experiences overall and within bridge clinic settings. Deductive codes were developed based on HIV risk environment frameworks and the Information-Motivation-Behavioral Skills model and inductive codes were added based on transcript review. Grounded content analysis was used to generate themes organized around the PrEP care continuum. RESULTS: The sample included 14 providers and 25 WSWUD. Most WSWUD were aware of PrEP and more than half had initiated PrEP at some point. However, most who initiated PrEP did not report success with daily oral adherence. Providers and WSWUD described facilitators and barriers to PrEP across the steps of the care continuum: Awareness, uptake, adherence, and retention. Facilitators for WSWUD included non-stigmatizing communication with providers, rapid wraparound substance use treatment and HIV services, having a PrEP routine, and service structures to support PrEP adherence. Barriers included low HIV risk perceptions and competing drug use and survival priorities. Provider facilitators included clinical note templates prompting HIV risk assessments and training. Barriers included discomfort discussing sex work risks, competing clinical priorities, and a lack of PrEP adherence infrastructure. CONCLUSION: WSWUD and bridge clinic providers favored integrated HIV prevention and substance use services in harm reduction and bridge clinic settings. Harm reduction and bridge clinic programs played a key role in HIV prevention and PrEP education for WSWUD. Effective behavioral and structural interventions are still needed to improve PrEP adherence for WSWUD.

"If you're strung out and female, they will take advantage of you": A qualitative study exploring drug use and substance use service experiences among women in Boston and San Francisco.

BACKGROUND: Significant disparities in substance use severity and treatment persist among women who use drugs compared to men. Thus, we explored how identifying as a woman was related to drug use and treatment experiences. METHODS: The study recruited participants for a qualitative interview study in Boston and San Francisco from January-November 2020. Self-identified women, age ≥ 18 years, with nonprescribed opioid use in the past 14 days were eligible for inclusion. The study team developed deductive codes based on intersectionality theory and inductive codes generated from transcript review, and identified themes using grounded content analysis. RESULTS: The study enrolled thirty-six participants. The median age was 46; 58 % were White, 16 % were Black, 14 % were Hispanic, and 39 % were unstably housed. Other drug use was common with 81 % reporting benzodiazepine, 50 % cocaine, and 31 % meth/amphetamine use respectively. We found that gender (i.e., identifying as a woman) intersected with drug use and sex work practices and exacerbated experiences of marginalization. Violence was ubiquitous in drug use environments. Some women reported experiences of gender-based violence in substance use service settings that perpetuated cycles of trauma and reinforced barriers to care. Substance use services that were women-led, safe, and responsive to women's needs were valued and sought after. CONCLUSION: Women reported a cycle of trauma and drug use exacerbated by oppression in substance use services settings. In addition to increasing access to gender-responsive care, our study highlights the need for greater research and examination of practices within substance use service settings that may be contributing to gender-based violence.

Academy of Breastfeeding Medicine Clinical Protocol #21: Breastfeeding in the Setting of Substance Use and Substance Use Disorder (Revised 2023).

Background: The Academy of Breastfeeding Medicine (ABM) revised the 2015 version of the substance use disorder (SUD) clinical protocol to review the evidence and provide updated literature-based recommendations related to breastfeeding in the setting of substance use and SUD treatments. Key Information: Decisions around breastfeeding are an important aspect of care during the peripartum period, and there are specific benefits and risks for substance-exposed mother-infant dyads. Recommendations: This protocol provides breastfeeding recommendations in the setting of nonprescribed opioid, stimulant, sedative-hypnotic, alcohol, nicotine, and cannabis use, and SUD treatments. Additionally, we offer guidance on the utility of toxicology testing in breastfeeding recommendations. Individual programs and institutions should establish consistent breastfeeding approaches that mitigate bias, facilitate consistency, and empower mothers with SUD. For specific breastfeeding recommendations, given the complexity of breastfeeding in mothers with SUD, individualized care plans should be created in partnership with the patient and multidisciplinary team with appropriate clinical support and follow-up. In general, breastfeeding is recommended among mothers who stop nonprescribed substance use by the time of delivery, and they should continue to receive ongoing postpartum care, such as lactation support and SUD treatment. Overall, enhancing breastfeeding education regarding substance use in pregnancy and lactation is essential to allow for patient-centered guidance.

Developing a Women's Health track within addiction medicine fellowship: reflections and inspirations.

BACKGROUND: Women who use drugs face sexism and intersectional stigma that influence their drug use experiences and treatment needs. There is a need to build the capacity of addiction medicine specialists who can deliver gender-responsive services and advance research and policy in women-focused addiction care. We describe the development of a Women's Health track within an addiction medicine fellowship program and reflect on successes, challenges, and future directions. MAIN BODY: The Women's Health track was developed in collaboration between program leaders in Addiction Medicine and Obstetrics/Gynecology. Implementing the track led to the development of women-focused rotations and continuity clinics, as well as enrichment of women's health didactic education for all fellows. The fellowship track spurred interdepartmental mentorship and collaboration on research and advocacy projects. CONCLUSION: Addiction medicine fellowships can replicate this curriculum model to advance women-focused education, research, and policy. Future curricula should focus on structural sexism in drug use and addiction treatment throughout a woman's life course.

Association of sex work and social-structural factors with non-fatal overdose among women who use drugs in Vancouver, Canada.

BACKGROUND: Women who use drugs (WWUD) and engage in sex work experience disproportionate sex- and drug-related harms, such as HIV, however comparatively little is known about their overdose risk. Therefore, we examined the association between sex work and overdose and secondarily explored the association of social-structural factors, such as policing and gendered violence, with overdose. METHODS: Data were derived from two community cohort studies based in Vancouver, Canada between 2005 to 2018. We used logistic regression with GEE to examine the associations between a) sex work and nonfatal overdose and b) social-structural and individual variables with overdose among WWUD who engaged in sex work during the study. Sex work, overdose, and other variables were time-updated, captured every six months. RESULTS: Among 857 WWUD included, 56% engaged in sex work during the study. Forty-three percent of WWUD engaged in sex work had at least one overdose compared to 26% of WWUD who did not. Sex work was not significantly associated with an increased odds of overdose (AOR = 1.14, 95% CI: 0.93-1.40). In the exploratory analysis amongst 476 WWUD engaged in sex work, social-structural variables associated with overdose in the multivariable model included exposure to: punitive policing (OR = 1.97, 95% CI: 1.30-2.96) and physical or sexual violence (OR = 2.55, 95% CI: 1.88-3.46). CONCLUSIONS: WWUD engaged in sex work had an increased overdose burden that may be driven by social-structural factors rather than sex work itself. Interventions that address policing and gendered violence represent potential targets for effective overdose prevention.

A retrospective study comparing postoperative opioid prescribing practices in an academic medical centre.

Background: In the midst of the North American opioid crisis, identifying and intervening on drivers of high-risk opioid prescriptions is an important step towards reducing iatrogenic harm. Objectives: We aimed to identify factors associated with variations in high-risk opioid discharge prescriptions, following select surgical procedures, to guide future quality improvement initiatives. Methods: This retrospective cohort study analyzed 1322 patients who underwent select open pelvic and open abdominal surgeries between January 1 and December 31, 2017, in a tertiary health care centre in Montreal. Results: Patients who underwent open abdominal surgeries were prescribed significantly higher daily doses of morphine milligram equivalents (MME) (45 mg; interquartile range, 30-60), than patients who underwent either a caesarean delivery (20 mg, 20-20) or a hysterectomy (30 mg, 22-30). After adjustment for multiple potential confounders, abdominal surgery was associated with 4 times the odds of receiving more than 50 MME at hospital discharge compared with pelvic surgeries (odds ratio, 3.96; 95% confidence interval, 1.31-11.97). The availability of postoperative preprinted order sets with fixed high doses of opioids was also highly associated with the outcome. Conclusion: In our institution, some surgeries were more likely to receive high-risk opioid prescriptions at discharge. Efforts to optimize safer prescribing practices should address the creation and/or updating of preprinted order sets to reflect current best practice guidelines. This initiative could be overseen by hospital pharmacy and therapeutics committees.

A Case of Phenibut Directed Detoxification Leading to Toxicity During the COVID-19 Pandemic.

BACKGROUND: Phenibut is a non-Food and Drug Administration-approved gamma-aminobutyric acid analog marketed in the United States as an anxiolytic, cognitive enhancer, and alcohol withdrawal treatment through online supplement vendors. In this case report, we describe a woman's self-directed detoxification with phenibut used to manage withdrawal symptoms from fentanyl and benzodiazepines in March 2020 during the height of the COVID-19 pandemic. CASE: A 38-year-old woman with severe opioid, benzodiazepine, gabapentin, stimulant use disorders developed altered mental status after oral phenibut ingestion intended to help self-manage opioid and benzodiazepine withdrawal. She chose self-directed detoxification as she feared COVID-19 exposure in detoxification facilities. Her altered mental status drove her to jump out a third-story window causing multiple spinal fractures. After a long hospitalization, she self-directed her discharge home due to concerns about COVID-19. Her premature discharge disrupted opioid and benzodiazepine use disorder treatment plans. CONCLUSION: This case highlights the risks of phenibut use for selfdirected detoxification. With COVID-19 related changes in the drug supply, people may be more likely to use online pharmaceuticals, therefore, substance use assessments should inquire about the online acquisition of new psychoactive drugs. Public health messaging regarding the risks of infectious disease transmission in addiction care settings is needed to guide addiction treatment choices among people who use substances.

The representation of females in clinical trials for substance use disorder conducted in the United States (2010-19).

BACKGROUND AND AIMS: Women have historically been under-represented in clinical research, but the extent to which this is true for substance use disorder (SUD) trials is unknown. We aimed to determine the ratio of female:male participation in clinical trials for SUDs and describe the reporting of sex-specific outcomes from 2010 to 2019. DESIGN: A retrospective cohort review of clinical trials involving people with SUD. SETTING: United States. PARTICIPANTS: Clinical trials including people with SUD registered in clinicaltrials.gov and completed between 1 January 2010 and 31 December 2019 were reviewed. Trials were excluded if they had < 30 participants, focused on SUD prevention, were conducted outside the United States and/or did not report data on participant sex or gender. MEASUREMENTS: The following were extracted for each trial: primary outcome, number of participants enrolled, analytical sample size, percentage of participants who were female, inclusion of transgender participants, whether sex-based analyses were performed, funding source, type of SUD and type of intervention. Relative representation in trials was examined using the female:male ratio, reported using median ratios and by year of trial completion. The proportion of females participating was adjusted using the underlying disease prevalence among females using National Survey on Drug Use and Health data. FINDINGS: A total of 316 trials met inclusion criteria: 274 were mixed-sex, 12 enrolled only males and 30 only females. In 274 mixed-sex trials, 40% of 57 544 participants were female. Only 22 trials (8%) reported any sex-specific analyses; four studies (1.5%) reported inclusion of transgender participants. Females represented 35% of participants in trials targeting illicit drug use disorder, 52% in nicotine use disorder and 29% in alcohol use disorder. Accounting for underlying disease prevalence revealed that women had the lowest relative enrollment in alcohol use disorder trials (median participation to prevalence ratio in 2017: 0.58; 95% confidence interval: 0.13, 0.91). CONCLUSIONS: A review of 316 US clinical trials for alcohol, nicotine and illicit substance use disorders completed between 2010 and 2019 showed that females were enrolled at lower rates than males overall. Only 8% of the trials reviewed reported sex-specific analyses and 1.5% reported transgender participants.

Chest X-ray Analysis With Deep Learning-Based Software as a Triage Test for Pulmonary Tuberculosis: An Individual Patient Data Meta-Analysis of Diagnostic Accuracy.

BACKGROUND: Automated radiologic analysis using computer-aided detection software (CAD) could facilitate chest X-ray (CXR) use in tuberculosis diagnosis. There is little to no evidence on the accuracy of commercially available deep learning-based CAD in different populations, including patients with smear-negative tuberculosis and people living with human immunodeficiency virus (HIV, PLWH). METHODS: We collected CXRs and individual patient data (IPD) from studies evaluating CAD in patients self-referring for tuberculosis symptoms with culture or nucleic acid amplification testing as the reference. We reanalyzed CXRs with three CAD programs (CAD4TB version (v) 6, Lunit v3.1.0.0, and qXR v2). We estimated sensitivity and specificity within each study and pooled using IPD meta-analysis. We used multivariable meta-regression to identify characteristics modifying accuracy. RESULTS: We included CXRs and IPD of 3727/3967 participants from 4/7 eligible studies. 17% (621/3727) were PLWH. 17% (645/3727) had microbiologically confirmed tuberculosis. Despite using the same threshold score for classifying CXR in every study, sensitivity and specificity varied from study to study. The software had similar unadjusted accuracy (at 90% pooled sensitivity, pooled specificities were: CAD4TBv6, 56.9% [95% confidence interval {CI}: 51.7-61.9]; Lunit, 54.1% [95% CI: 44.6-63.3]; qXRv2, 60.5% [95% CI: 51.7-68.6]). Adjusted absolute differences in pooled sensitivity between PLWH and HIV-uninfected participants were: CAD4TBv6, -13.4% [-21.1, -6.9]; Lunit, +2.2% [-3.6, +6.3]; qXRv2: -13.4% [-21.5, -6.6]; between smear-negative and smear-positive tuberculosis was: were CAD4TBv6, -12.3% [-19.5, -6.1]; Lunit, -17.2% [-24.6, -10.5]; qXRv2, -16.6% [-24.4, -9.9]. Accuracy was similar to human readers. CONCLUSIONS: For CAD CXR analysis to be implemented as a high-sensitivity tuberculosis rule-out test, users will need threshold scores identified from their own patient populations and stratified by HIV and smear status.

"No home to take methadone to": Experiences with addiction services during the COVID-19 pandemic among survivors of opioid overdose in Boston.

INTRODUCTION: We conducted a qualitative study to explore the impact of the COVID-19 pandemic on experiences with addiction treatment and harm reduction services. METHODS: The study recruited participants from Boston, Massachusetts, aged 18-65 who had a history of opioid use disorder and overdose, from a parent study (REpeated dose Behavioral intervention to reduce Opioid Overdose, REBOOT) to participate between August and October 2020. In-depth individual interviews explored the impact of the COVID-19 pandemic on addiction service experiences. We conducted a grounded content analysis that examined codes related to addiction service access and engagement during the pandemic to compare and categorize participants according to their experiences. RESULTS: The study enrolled twenty participants. The mean age was 42 years; most identified as white (n = 16); ten participants identified as men, nine as cis-gender women, and one as a trans-gender woman. Participants described their experiences with COVID-19-driven changes to addiction care (methadone take homes, televisits for either buprenorphine or behavioral health services, and syringe service outreach) access and engagement as: 1) liberating (n = 7), 2) destabilizing (n = 8), or 3) unjust (n = 5). Participants in the liberating group found adaptations allowed for increased flexibility, freedom, and safety from COVID-19. This group was mostly housed and had strong social supports that facilitated participation in adapted treatment programs. COVID-19-related changes to addiction treatment disrupted routine and community supports among those in the destabilizing group. Participants in the unjust group felt that adaptations exacerbated inequities as a lack of housing and other social supports prohibited them from benefiting from the relaxed restrictions to methadone or buprenorphine. This group was mostly unhoused and found that adaptations did not adequately mitigate other inequities worsened by public health mandates for unhoused people who use drugs. CONCLUSION: Relaxed restrictions on medications for opioid use disorder created opportunities for improved patient-centered care. Concrete measures that address service barriers, such as phone or transportation access, may have reduced destabilizing and unjust experiences reported by our participants. However, addiction care inequities will persist if drivers of marginalization, specifically a lack of housing, remain unaddressed.

Gender Dynamics in Substance Use and Treatment: A Women's Focused Approach.

Gender impacts substance use initiation, substance use disorder development, engagement with treatment, and harms related to drug and alcohol use. Using the biopsychosocial model of addiction, this review provides a broad summary of barriers and facilitators to addiction services among women. It also reviews substance use among pregnant and parenting women and approaches to care. Given the increasing rates of substance use among women, there is a need to implement and scale-up gender-responsive addiction programming and pursue advocacy at the policy level that addresses the root drivers of substance use inequities among women.

Outcomes of Ottawa, Canada's Managed Opioid Program (MOP) where supervised injectable hydromorphone was paired with assisted housing.

BACKGROUND: The Ottawa Inner City Health's Managed Opioid Program is the first, to our knowledge, to pair injectable opioid agonist hydromorphone treatment with assisted housing for people experiencing homelessness with severe opioid use disorder (OUD) and injection drug use. We aimed to describe this program and evaluate retention, health, and social wellbeing outcomes. METHODS: We retrospectively assessed the first cohort of clients enrolled in the Managed Opioid Program between August 2017-2018. The primary outcome was retention at 12 months. Secondary outcomes included injectable and oral opioid dose titration, non-prescribed opioid use, overdoses, connection with behavioural health services, and social well-being. Descriptive statistics were used to summarize baseline demographics and secondary outcomes. Actuarial survival analysis was used to assess retention among participants. RESULTS: The study sample included 26 participants: median age was 36 years, 14 were female, 22 were White, eight had alcohol use disorders, 25 had stimulant use disorders, and all had a history of concurrent psychiatric illness. Retention at 12 months was 77% (95% CI 62-95). Throughout the first-year participants' opioid treatment doses increased. The median daily dose of injectable hydromorphone was 36 mg [17-54 mg] and 156 mg [108-188 mg] at enrollment and one year respectively. The median daily dose of oral opioid treatment was 120-milligram morphine equivalents [83-180 mg morphine equivalents] and 330-milligram morphine equivalents [285-428 mg morphine equivalents] at enrollment and one year respectively. Over half had no overdoses and there were no deaths among participants who remained enrolled. At one year, 45% stopped non-prescribed opioid use, 96% connected to behavioral health services, 73% reconnected with estranged families, and 31% started work or vocational programs. CONCLUSION: Individuals with severe OUD engaged in injectable hydromorphone treatment and housing showed high retention in care and substantive improvements in patient-centered health and social well-being outcomes.

"You need money to get high, and that's the easiest and fastest way:" A typology of sex work and health behaviours among people who inject drugs.

BACKGROUND: In the United States, the criminalization and stigmatization of drug use and sex work contribute to infectious disease transmission and healthcare disengagement. People who inject drugs (PWID) and engage in sex work experience exacerbated HIV risk. In the context of the ongoing HIV and overdose epidemics little research describes why PWID engage in sex work and its relative HIV risk. To inform intervention needs, we aimed to create a typology of sex work among PWID with a focus on HIV risk and healthcare utilization behaviours. METHODS: We drew from in-depth interviews conducted across Massachusetts and Rhode Island from 2016-2019. Participants were ≥18 years old and self-reported past-month injection drug use and HIV-negative status. Using data from individuals reporting sex work experience (n=33/78), we utilized the framework method to develop a typology of perspectives on sex work engagement and attributes pertaining to HIV risk and healthcare utilization behaviours. RESULTS: We uncovered varying perspectives on sex work and associated HIV risks and prevention needs. A typology included three groups who viewed their sex work engagement as a (1) consistent job, (2) income supplement, or (3) survival method to abate withdrawal symptoms. The first group described more consistent sexual and injection behaviours to mitigate HIV risk than the second group. The third group appeared particularly vulnerable to HIV, describing inconsistent condom use and frequent sharing of injection equipment, low healthcare utilization, and limited disclosure of sex work and injection drug use to healthcare providers. CONCLUSION: Findings highlight distinct perspectives on sex work among PWID involved in it and corresponding perceptions of HIV risk and healthcare utilization behaviours. Understanding the nuances in sex work engagement among PWID can inform interventions to prevent infectious disease transmission, including efforts to further connect this marginalized population to harm reduction, health, and low barrier opioid treatment services.

Competing risks of women and men who use fentanyl: "The number one thing I worry about would be my safety and number two would be overdose".

BACKGROUND: Standard public health approaches to risk communication do not address the gendered dynamics of drug use. The aim of this study was to explore perceptions of fentanyl-related risks among women and men to inform future risk communication approaches. METHODS: We conducted a qualitative study, purposively sampling English-speaking women and men, aged 18-25 or 35+ years, with past 12-month illicitly manufactured fentanyl use. In-depth individual interviews explored experiences of women and men related to overdose and fentanyl use. We conducted a grounded content analysis examining specific codes related to overdose and other health or social risks attributed to drug use. Using a constant comparison technique, we explored commonalities and differences in themes between women and men. RESULTS: The study enrolled twenty-one participants, 10 women and 11 men. All participants had personal overdose experiences. Both women and men described overdosing as a "chronic" condition and expressed de-sensitization to the risk of overdose. Women and men described other risks around health, safety, and state services that often superseded their fear of overdose. Women feared physical and sexual violence and prioritized caring for children and maintaining relations with child protective services, while men feared violence arising from obtaining and using street drugs and incarceration. Only women reported that fear of violence prevented their utilization of harm reduction services. CONCLUSIONS: Experiences with overdose and risk communication among people who use fentanyl-containing opioids varied by gender. The development of gender-responsive programs that address targeted concerns may be an avenue to enhance engagement with harm reduction and treatment services and create safe spaces for women not currently accessing available services.

Adapting inpatient addiction medicine consult services during the COVID-19 pandemic.

BACKGROUND: We describe addiction consult services (ACS) adaptations implemented during the Novel Coronavirus Disease 2019 (COVID-19) pandemic across four different North American sites: St. Paul's Hospital in Vancouver, British Columbia; Oregon Health & Sciences University in Portland, Oregon; Boston Medical Center in Boston, Massachusetts; and Yale New Haven Hospital in New Haven, Connecticut. EXPERIENCES: ACS made system, treatment, harm reduction, and discharge planning adaptations. System changes included patient visits shifting to primarily telephone-based consultations and ACS leading regional COVID-19 emergency response efforts such as substance use treatment care coordination for people experiencing homelessness in COVID-19 isolation units and regional substance use treatment initiatives. Treatment adaptations included providing longer buprenorphine bridge prescriptions at discharge with telemedicine follow-up appointments and completing benzodiazepine tapers or benzodiazepine alternatives for people with alcohol use disorder who could safely detoxify in outpatient settings. We believe that regulatory changes to buprenorphine, and in Vancouver other medications for opioid use disorder, helped increase engagement for hospitalized patients, as many of the barriers preventing them from accessing care on an ongoing basis were reduced. COVID-19 specific harm reductions recommendations were adopted and disseminated to inpatients. Discharge planning changes included peer mentors and social workers increasing hospital in-reach and discharge outreach for high-risk patients, in some cases providing prepaid cell phones for patients without phones. RECOMMENDATIONS FOR THE FUTURE: We believe that ACS were essential to hospitals' readiness to support patients that have been systematically marginilized during the pandemic. We suggest that hospitals invest in telehealth infrastructure within the hospital, and consider cellphone donations for people without cellphones, to help maintain access to care for vulnerable patients. In addition, we recommend hospital systems evaluate the impact of such interventions. As the economic strain on the healthcare system from COVID-19 threatens the very existence of ACS, overdose deaths continue rising across North America, highlighting the essential nature of these services. We believe it is imperative that health care systems continue investing in hospital-based ACS during public health crises.

False-negative RT-PCR for COVID-19 and a diagnostic risk score: a retrospective cohort study among patients admitted to hospital.

OBJECTIVE: To describe the characteristics and outcomes of patients with a clinical diagnosis of COVID-19 and false-negative SARS-CoV-2 reverse transcription-PCR (RT-PCR), and develop and internally validate a diagnostic risk score to predict risk of COVID-19 (including RT-PCR-negative COVID-19) among medical admissions. DESIGN: Retrospective cohort study. SETTING: Two hospitals within an acute NHS Trust in London, UK. PARTICIPANTS: All patients admitted to medical wards between 2 March and 3 May 2020. OUTCOMES: Main outcomes were diagnosis of COVID-19, SARS-CoV-2 RT-PCR results, sensitivity of SARS-CoV-2 RT-PCR and mortality during hospital admission. For the diagnostic risk score, we report discrimination, calibration and diagnostic accuracy of the model and simplified risk score and internal validation. RESULTS: 4008 patients were admitted between 2 March and 3 May 2020. 1792 patients (44.8%) were diagnosed with COVID-19, of whom 1391 were SARS-CoV-2 RT-PCR positive and 283 had only negative RT-PCRs. Compared with a clinical reference standard, sensitivity of RT-PCR in hospital patients was 83.1% (95% CI 81.2%-84.8%). Broadly, patients with false-negative RT-PCR COVID-19 and those confirmed by positive PCR had similar demographic and clinical characteristics but lower risk of intensive care unit admission and lower in-hospital mortality (adjusted OR 0.41, 95% CI 0.27-0.61). A simple diagnostic risk score comprising of age, sex, ethnicity, cough, fever or shortness of breath, National Early Warning Score 2, C reactive protein and chest radiograph appearance had moderate discrimination (area under the receiver-operator curve 0.83, 95% CI 0.82 to 0.85), good calibration and was internally validated. CONCLUSION: RT-PCR-negative COVID-19 is common and is associated with lower mortality despite similar presentation. Diagnostic risk scores could potentially help triage patients requiring admission but need external validation.

Cross-sectional observational study of epidemiology of COVID-19 and clinical outcomes of hospitalised patients in North West London during March and April 2020.

OBJECTIVE: The aim of this paper is to describe evolution, epidemiology and clinical outcomes of COVID-19 in subjects tested at or admitted to hospitals in North West London. DESIGN: Observational cohort study. SETTING: London North West Healthcare NHS Trust (LNWH). PARTICIPANTS: Patients tested and/or admitted for COVID-19 at LNWH during March and April 2020 MAIN OUTCOME MEASURES: Descriptive and analytical epidemiology of demographic and clinical outcomes (intensive care unit (ICU) admission, mechanical ventilation and mortality) of those who tested positive for COVID-19. RESULTS: The outbreak began in the first week of March 2020 and reached a peak by the end of March and first week of April. In the study period, 6183 tests were performed in on 4981 people. Of the 2086 laboratory confirmed COVID-19 cases, 1901 were admitted to hospital. Older age group, men and those of black or Asian minority ethnic (BAME) group were predominantly affected (p<0.05). These groups also had more severe infection resulting in ICU admission and need for mechanical ventilation (p<0.05). However, in a multivariate analysis, only increasing age was independently associated with increased risk of death (p<0.05). Mortality rate was 26.9% in hospitalised patients. CONCLUSION: The findings confirm that men, BAME and older population were most commonly and severely affected groups. Only older age was independently associated with mortality.