Combining patient reported outcomes and EHR data to understand population level treatment needs: correcting for selection bias in the migraine signature study

Background Electronic health records (EHR) data can be used to understand population level quality of care especially when supplemented with patient reported data. However, survey non-response can result in biased population estimates. As a case study, we demonstrate that EHR and survey data can be combined to estimate primary care population prescription treatment status for migraine stratified by migraine disability, without and with adjustment for survey non-response bias. We selected disability as it is associated with survey participation and patterns of prescribing for migraine. Methods A stratified random sample of Sutter Health adult primary care (PC) patients completed a digital survey about headache, migraine, and migraine related disability. The survey data from respondents with migraine were combined with their EHR data to estimate the proportion who had prescription orders for acute or preventive migraine treatments. Separate proportions were also estimated for those with mild disability (denoted “mild migraine”) versus moderate to severe disability (denoted mod-severe migraine) without and with correction, using the inverse propensity weighting method, for non-response bias. We hypothesized that correction for non-response bias would result in smaller differences in proportions who had a treatment order by migraine disability status. Results The response rate among 28,268 patients was 8.2%. Among survey respondents, 37.2% had an acute treatment order and 16.8% had a preventive treatment order. The response bias corrected proportions were 26.2% and 11.6%, respectively, and these estimates did not differ from the total source population estimates (i.e., 26.4% for acute treatments, 12.0% for preventive treatments), validating the correction method. Acute treatment orders proportions were 32.3% for mild migraine versus 37.3% for mod-severe migraine and preventive treatment order proportions were 12.0% for mild migraine and 17.7% for mod-severe migraine. The response bias corrected proportions for acute treatments were 24.8% for mild migraine and 26.6% for mod-severe migraine and the proportions for preventive treatment were 8.1% for mild migraine and 12.0% for mod-severe migraine. Conclusions In this study, we combined survey data with EHR data to better understand treatment needs among patients diagnosed with migraine. Migraine-related disability is directly related to preventive treatment orders but less so for acute treatments. Estimates of treatment status by self-reported disability status were substantially over-estimated among those with moderate to severe migraine-related disability without correction for non-response bias.

Characteristics of people on community treatment orders in Australia: Data from the 2010 National Survey of High Impact Psychosis

Objective: Existing evidence on factors associated with community treatment order placement is largely restricted to administrative data. We utilised the data from a large nationally representative sample to compare the demographic, clinical, social functioning, substance use and service utilisation profiles of people living with psychosis under community treatment orders with those who were not. Methods: Participants were grouped based on whether they had been subject to a community treatment order in the past 12 months or not. We conducted logistic regressions to examine demographic, clinical, social functioning, substance use and service utilisation profiles associated with the two groups. Results: People who had recently been subject to community treatment orders were more likely to be treated with long-acting injectable antipsychotics and lacked insight but were less likely to report suicidal ideation. They also had higher psychiatric inpatient admission rates but a lower frequency of general practitioner visits. Conclusion: People on community treatment orders in Australia may differ from those who are not under a community treatment order in their treatment needs. Resources and care provision must match the needs of this particularly vulnerable group.

POS0678 DOES SILDENAFIL IMPROVE ENDOTHELIAL DYSFUNCTION IN RHEUMATOID ARTHRITIS? – A PILOT CLINICAL TRIAL

Background:Rheumatoid arthritis (RA) is independently associated with an increased risk of cardiovascular disease (CVD). One of the early stages of atherosclerosis is endothelial dysfunction, which is increased in RA. Using drugs to target endothelial dysfunction is a promising novel strategy for CVD prevention in RA. Sildenafil has been shown to improve endothelial function in diabetics, who have similar increased CVD risk. Our hypothesis was that sildenafil use may be a novel primary CVD prevention strategy in RA.Objectives:To determine if sildenafil use in RA patients improves endothelial dysfunction (as measured by brachial artery flow-mediated dilation [FMD] and peripheral arterial tone [PAT]), as well as serum inflammatory and atherosclerosis biomarkers.Methods:This NIH-funded study was a phase II, randomized double-blind placebo-controlled crossover efficacy trial of 25 RA patients, with no known history of CVD, but at least one traditional CVD risk factor. Patients were randomized 1:1 to receive either sildenafil or placebo for 3 months, then after a 2-week washout, crossed over to each respective group for an additional 3 months. Vascular studies (FMD and PAT) and serum atherosclerosis biomarkers (e-Selectin, ICAM-1, VCAM-1) were performed at baseline, 3 months pre- and post-washout, and 6 months. Adverse events were collected. Given the cross-over design, analyses included a random effects model for within-subject comparisons of sildenafil versus placebo periods, adjusting for the baseline (FMD or EndoPAT) within that period and a term for treatment order. All tests were 2-sided with α=0.05.Results:A total of 233 subjects were assessed for eligibility, with 25 subjects being randomized after written informed consent. A total of 13 subjects were randomized to placebo first, and 12 to sildenafil first. Baseline characteristics were similar between those randomized to Placebo vs. Sildenafil first. Mean age was 62.0+/-10.9 years; 84% were female; and 92% were white. A total of 6 adverse events experienced in 3 subjects occurred. The primary endpoint (increase in %FMD in Sildenafil period vs. Placebo period) was not significant (p=0.19). However, note the study was powered at 80% to detect an effect size of 0.37 for change in %FMD or biomarker with a sample size of 60, not 25. However, sildenafil use was associated with a significant increase (improvement) by 0.200 units of PAT ratio (p=0.003) compared with placebo, adjusted by treatment order and baseline PAT ratio (within the given treatment period). Exploratory linear mixed models comparing e-Selectin, ICAM-1, and VCAM-1 between Sildenafil vs. Placebo periods, adjusted for treatment order and the baseline biomarker level, did not show any significant differences except for ICAM-1 (55.3 units higher in Sildenafil vs. Placebo periods, p=0.011).Conclusion:In this pilot trial of 25 RA subjects, sildenafil use was associated with a significant increase (improvement) in endothelial function as measured by PAT. However, there was no significant difference in FMD. The study is limited due to the small sample size, which was impacted by slow recruitment as well as the COVID-19 pandemic. Future larger studies are required to assess whether other PDE5 inhibitors may improve endothelial dysfunction in RA and other autoimmune disease patients at high risk of CVD.References:[1]Maradit-Kremers H, Crowson CS, Nicola PJ, et al. Increased unrecognized coronary heart disease and sudden deaths in rheumatoid arthritis: a population-based cohort study. Arthritis Rheum 2005;52:402-11.[2]Peters MJ, van Halm VP, Voskuyl AE, et al. Does rheumatoid arthritis equal diabetes mellitus as an independent risk factor for cardiovascular disease? A prospective study. Arthritis Rheum 2009;61:1571-9.[3]Deyoung L, Chung E, Kovac JR, et al. Daily use of sildenafil improves endothelial function in men with type 2 diabetes. J Andrology 2012;33:176-80.Disclosure of Interests:None declared

Characteristics of people on long-acting injectable antipsychotics in Australia: Data from the 2010 National Survey of High Impact Psychosis

Objective: This study investigates (1) the proportion of people with psychosis who are on long-acting injectable antipsychotics; (2) the difference in the demographic, clinical, substance use and adverse drug reaction profiles of people taking long-acting injectables compared to oral antipsychotics; and (3) the differences in the same profiles of those on first-generation antipsychotic versus second-generation antipsychotic long-acting injectables. Methods: Data were collected as part of the Survey of High Impact Psychosis. For this study, participants with diagnoses of schizophrenia or schizoaffective disorder who were on any antipsychotic medication were included ( N = 1049). Results: Nearly a third (31.5%) of people with psychosis were on long-acting injectables, of whom 49.7% were on first-generation antipsychotic long-acting injectables and 47.9% were on second-generation antipsychotic long-acting injectables. This contrasts with oral antipsychotics where there was a higher utilisation of second-generation antipsychotics (86.3%). Of note, compared to those on the oral formulation, people on long-acting injectables were almost four times more likely to be under a community treatment order. Furthermore, people on long-acting injectables were more likely to have a longer duration of illness, reduced degree of insight, increased cognitive impairment as well as poor personal and social functioning. They also reported more adverse drug reactions. Compared to those on first-generation antipsychotic long-acting injectables, people on SGA long-acting injectables were younger and had had a shorter duration of illness. They were also more likely to experience dizziness and increased weight, but less likely to experience muscle stiffness or tenseness. Conclusion: Long-acting injectable use in Australia is associated with higher rates of community treatment order use, as well as poorer insight, personal and social performance, and greater cognitive impairment. While long-acting injectables may have the potential to improve the prognosis of people with psychosis, a better understanding of the choices behind the utilisation of long-acting injectable treatment in Australia is urgently needed.

Outcomes of Victorian Prevention and Recovery Care Services: A matched pairs comparison

Objective: In Victoria, Prevention and Recovery Care Services have been established to provide a partial alternative to inpatient admissions through short-term residential mental health care in the community. This study set out to determine whether Prevention and Recovery Care Services are achieving their objectives in relation to reducing service use and costs, fostering least restrictive care and leading to positive clinical outcomes. Methods: We matched 621 consumers whose index admission in 2014 was to a Prevention and Recovery Care (‘PARCS consumers’) with 621 similar consumers whose index admission in the same year was to an acute inpatient unit and who had no Prevention and Recovery Care stays for the study period (‘inpatient-only consumers’). We used routinely collected data to compare them on a range of outcomes. Results: Prevention and Recovery Care Services consumers made less subsequent use of acute inpatient services and, on balance, incurred costs that were similar to or lower than inpatient-only consumers. They were also less likely to spend time on an involuntary treatment order following their index admission. Prevention and Recovery Care Services consumers also experienced positive clinical outcomes over the course of their index admission, but the magnitude of this improvement was not as great as for inpatient-only consumers. This type of clinical improvement is important for Prevention and Recovery Care Services, but they may place greater emphasis on personal recovery as an outcome. Conclusion: Prevention and Recovery Care Services can provide an alternative, less restrictive care option for eligible consumers who might otherwise be admitted to an acute inpatient unit and do so at no greater cost.

Multidisciplinary Teamwork and the Insanity Defence: A Case of Infanticide in Iraq

In April 2018, the author had an opportunity to visit Al-Rashad Hospital (where the only forensic psychiatry unit in Iraq exists) and he had the chance to meet with the brave psychiatrists and mental health professionals who worked in the oldest psychiatric hospital in Iraq. The author was amazed by how these colleagues operate amidst all challenges, limited financial resources and funding difficulties.The author was impressed by the work of the forensic psychiatry committee which determines the criminal responsibility of a large number of cases from all over Iraq. He had the chance of attending the Ministry of Health’s specialist panel which determines criminal responsibility for mentally disordered detainees. He attended the assessment of a young lady who was remanded on suspicion of killing her 1 year old son (infanticide). The panel and after two interviews concluded that the suspect had autism and learning disability. The patient was deemed irresponsible for her criminal behaviour and she was eventually granted an equivalent of a hospital treatment order.

Pain Management and Opioid Free Treatment Order Sets: An Evolving Role for Pharmacists

Over the past twenty five years, significant changes to the assessment and treatment of pain have occurred. In the 1990s, the identification of "pain as the fifth vital sign" impacted how providers assessed and treated pain. Now, with the opioid epidemic and recommendations from multiple organizations to remove pain as the fifth vital sign, the practice of pain management is changing again. Despite these changes, pain is still a common condition many patients experience. It is estimated about 50% of older adults in the community report daily pain, and there is an increased prevalence of pain in the facility setting, with 45-80% of residents reporting chronic pain impacting their quality of life. With the growing number of older adults in the United States, pharmacists working with geriatric patients need to be familiar with the treatment of pain and new approaches that are being utilized.

Streamlined Poststroke Treatment Order Sets During the SARS-CoV-2 Pandemic

Background and Purpose: Standard poststroke treatment monitoring protocols are made problematic during the coronavirus disease 2019 (COVID-19) pandemic by the frequency of patient assessments, requiring repeated donning and doffing procedures in a short interval of time. Methods: A streamlined poststroke treatment protocol was developed to limit frequency of patient encounters while maximizing the yield of each encounter by grouping together different components of poststroke care into single bedside visits. Results: Streamlined order sets were developed late March 2020. During the first 6 weeks following implementation, 70 patients were admitted to a geographically defined designated warm COVID-19 unit with modified poststroke care order sets. Of these, 33 (47.1%) patients received acute reperfusion therapy. All but 3 patients evolved favorably with either stable or improving National Institutes of Health Stroke Scale at 24 hours. In the 3 patients who experienced early neurological deterioration, none were found to be attributable to insufficient patient monitoring. Conclusions: Adapting preexisting poststroke care protocols may be necessary while the risk of COVID-19 infection remains high. We propose a streamlined approach to facilitate poststroke monitoring in patients with stroke with unknown COVID status.

Assessment of phage-mediated inhibition of Salmonella Typhimurium treated with sublethal concentrations of ceftriaxone and ciprofloxacin

ABSTRACT This study was designed to evaluate the synergistic effect of phage (P22) and antibiotic on the inhibition of Salmonella Typhimurium exposed to ceftriaxone (CEF) and ciprofloxacin (CIP). The effect of phage and antibiotic treatments was evaluated by plaque size, disk diffusion, antibiotic susceptibility and phage multiplication assays. The sequential treatment effect of phage and antibiotic was carried out in different treatment order and time for 12 h at 37°C. P22 plaque sizes were increased by 28 and 71%, respectively, in the presence of CEF and CIP. The clear zone sizes in disk diffusion assay were significantly increased to >37 mm in the presence of CEF and CIP compared to the control (28–31 mm). Pre-treatment with P22 enhanced the antimicrobial effect of CIP, showing >2 log reduction after a 12 h incubation. Phage P22 combined with antibiotics (CEF and CIP) effectively inhibited the growth of S. Typhimurium depending on the treatment order and time. These results provide useful information for understanding the synergistic effect of phage and antibiotic treatment which can be an effective option to control antibiotic resistant pathogens.