Mental and social wellbeing trajectory during the pandemic for vulnerable populations.

Objectives: We investigated changes over time in mental and social wellbeing indicators for vulnerable population subgroups during the pandemic. These groups were younger people, people with disabilities, low-income groups, unemployed, culturally, and linguistically diverse communities (CaLD), and Aboriginal and Torres Strait Islander peoples. Methods: A series of four repeated population representative surveys were conducted in June 2020, September 2020, January 2022, and June 2022. Questions included items on psychological distress, financial hardship, social connection, and life satisfaction. Results: For most groups, social connection and life satisfaction improved in 2022 relative to 2020. Psychological distress and financial hardship showed the opposite pattern, with some groups having worse results in 2022 relative to 2020. People without any vulnerability had better mental health and social wellbeing outcomes at each time point relative to the vulnerable population subgroups. Conclusion: Pandemic-related policies had differential effects over time and for different population groups. Future policies and research need to closely monitor how they impact population subgroups, and the overall results clearly demonstrate the inequity in mental health and social wellbeing outcomes for vulnerable population cohorts.

A Settings and Systems Approach to Promoting the Health and Wellbeing of People with an Intellectual Disability.

Research has shown that people with an intellectual disability have higher rates of certain preventable health conditions and a higher rate of avoidable mortality relative to the general population. With respect to health behaviours, they also have lower levels of physical activity and poorer nutrition. Despite the increased health needs, this population cohort is less likely to have the opportunity to participate in health promotion programs. The interventions that have been delivered are programmatic and individual in focus and have lacked a broader ecological and settings focus, which makes them very difficult to scale. Health promotion programs designed for the general population, such as lifestyle campaigns, rarely reach people with an intellectual disability. This increases the importance of ensuring that the settings in which they live and engage with are as health promoting as possible. Interventions have been particularly absent in the workplace for people with an intellectual disability. This paper highlights gaps in a settings-and-systems-based approach to promoting the health and wellbeing of people with an intellectual disability, particularly with respect to workplace health promotion. The paper concludes with recommendations for a systems approach that integrates approaches across multiple settings to better promote the health of this population cohort.

A systems science leverage point analysis of climate change advocacy.

Failure of governments across the world to address climate change has fuelled social movements focused on climate-related policy and action. Research analysing these movements has focused mainly on the types of strategies employed including blockades and occupations, marches and petitions, divestment, boycotts and litigation as well as how groups are framing climate change as a problem. What has been largely missed are the ways these groups are framing the change they want to see, that is their demands to governments. Not all demands and actions have the same potential to create the changes needed to mitigate climate change. Used in public health and health promotion, the systems science Intervention Level Framework (ILF) is a tool that can help analyse to what extent different demands have the leverage to create change in a system. We use the ILF to analyse 131 demands from 35 different climate-related advocacy groups in Australia. Results show demands are more focused on lower system leverage points, such as stopping particular projects, rather than on more impactful leverage points, such as the governance structures that determine climate-related policy and decision-making mechanisms. Further, the results highlight the lack of attention on public health related topics of transport and food systems. This paper shows how a systems science framework used in health promotion, the ILF, could enable climate advocacy groups to more effectively target demands to achieve more impactful outcomes from governments, corporations and the public.

What Can Public Health Administration Learn from the Decision-Making Processes during COVID-19?

Human decision-making is prone to biases and the use of heuristics that can result in making logical errors and erroneous causal connections, which were evident during COVID-19 policy developments and potentially contributed to the inadequate and costly responses to COVID-19. There are decision-making frameworks and tools that can improve organisational decision-making. It is currently unknown as to what extent public health administrations have been using these structured organisational-level decision-making processes to counter decision-making biases. Current reviews of COVID-19 policies could examine not just the content of policy decisions but also how decisions were made. We recommend that understanding whether these decision-making processes have been used in public health administration is key to policy reform and learning from the COVID-19 pandemic. This is a research and practice gap that has significant implications for a wide range of public health policy areas and potentially could have made a profound difference in COVID-19-related policy responses.

Organisational structures and processes for health and well-being: insights from work integration social enterprise.

BACKGROUND: Previous research on employee well-being for those who have experienced social and economic disadvantage and those with previous or existing mental health conditions has focused mainly on programmatic interventions. The purpose of this research was to examine how organisational structures and processes (such as policies and culture) influence well-being of employees from these types of backgrounds. METHODS: A case study ethnographic approach which included in-depth qualitative analysis of 93 semi-structured interviews of employees, staff, and managers, together with participant observation of four social enterprises employing young people. RESULTS: The data revealed that young people were provided a combination of training, varied work tasks, psychosocial support, and encouragement to cultivate relationships among peers and management staff. This was enabled through the following elements: structure and space; funding, finance and industry orientation; organisational culture; policy and process; and fostering local service networks.. The findings further illustrate how organisational structures at these workplaces promoted an inclusive workplace environment in which participants self-reported a decrease in anxiety and depression, increased self-esteem, increased self-confidence and increased physical activity. CONCLUSIONS: Replicating these types of organisational structures, processes, and culture requires consideration of complex systems perspectives on implementation fidelity which has implications for policy, practice and future research.

Application of theories of the policy process in research on consumption of sustainable diets: a systematic review.

BACKGROUND: There is a significant global lack of policy action on consumption of sustainable diets. Application of political science theories such as theories of the policy process can help in understanding policy inaction. Applying these theories could provide a more in-depth understanding of how various influences on the policy process shape decision making for consumption of sustainable diet policy. METHODS: A systematic review to examine application of eight key political science theories of the policy process to research on consumption of sustainable diets was conducted. RESULTS: The review identified no papers applying a theory of the policy process although 17 papers did mention or discuss influences on the policy process that are common elements within theories of the policy process. Most notably these elements were the influence of coalitions/networks, evidence use, narratives and framing, institutional and political system factors, and the importance of value and belief systems and socio-cultural norms. However, in most papers these influences were not examined in a detailed or in-depth way and often presented as suggestions for lack of policy action without the support of empirical data or application of any theory. CONCLUSIONS: Most research discussing policy inaction on the consumption of sustainable diets fails to utilise political science theories of the policy process, although a small number of papers include mention of or discussion of influences on the policy process. Application of political science theories could provide a more in-depth understanding of how different determinants might shape decision making at various points in the policy process. This could help identify key reasons for policy inaction on the consumption of sustainable diets and suggest possible ways to increase attention and action on the issue from policy decision makers.

The health and well-being impacts of a work integration social enterprise from a systems perspective.

Recent research has drawn upon the social determinants of health (SDH) framework to attempt to systematize the relationship between social enterprise and health. In this article, we adopt a realist evaluation approach to conceptualize social enterprises, and work integration social enterprises in particular, as 'complex interventions' that necessarily produce differential health outcomes for their beneficiaries, communities and staff. Drawing upon the findings from four social enterprises involving a range of methods including 93 semi-structured interviews with employees, managers and enterprise partners, together with participant observation, we demonstrate that these health outcomes are influenced by a limitless mix of complex and dynamic interactions between systems, settings, spaces, relationships and organizational and personal factors that cannot be distilled by questions of causality and attribution found in controlled trial designs. Given the increased policy focus on the potential of social enterprises to affect the SDH, this article seeks to respond to evidence gaps about the mechanisms and contexts through which social enterprises promote or constrain health outcomes, and thereby provide greater clarity about how research evidence can be used to support the social enterprise sector and policy development more broadly.

Work integration social enterprises (WISEs) are hybrid organizations that operate as businesses with a social purpose. WISEs focus on employment of people excluded from open employment, often as a result of discriminatory attitudes and practices of employers to people from minority groups and those experiencing disability or health-related problems. There is a lack of research on the ways in which a WISE could positively impact on individual health and well-being. We interviewed employees, managers and enterprise partners, together with participant observation, across four social enterprises to understand these dynamics. Through a number of strategies including flexible workplace structures, a culture of acceptance and support, encouragement to take risks and make mistakes and creative use of space, the participants described changes to health and well-being such as decreased symptoms of anxiety and depression, increased social connections, improved physical activity and increased confidence and self-esteem. Results show a mix of strategies combined with individually tailored support; this has implications for the type of research that is appropriate to understand these impacts. We conclude with suggestions on how future research could use complex research designs to understand how WISEs can influence health and well-being.

Estimating the reduction in US mortality if cigarettes were largely replaced by e-cigarettes.

BACKGROUND: Recent estimates indicated substantially replacing cigarettes by e-cigarettes would, during 2016-2100, reduce US deaths and life-years lost (millions) by 6.6 and 86.7 (Optimistic Scenario) and 1.6 and 20.8 (Pessimistic). To provide additional insight we use alternative modelling based on a shorter period (1991-2040), four main smoking-associated diseases, deaths aged 30-79 years, and a full product history. We consider variations in: assumed effective dose of e-cigarettes versus cigarettes (F); their relative quitting rate (Q); proportions smoking after 10 years (X); and initiation rate (I) of vaping, relative to smoking. METHODS: We set F = 0.05, X = 5%, Q = 1.0 and I = 1.0 (Main Scenario) and F = 0.4, X = 10%, Q = 0.5 and I = 1.5 (Pessimistic Scenario). Sensitivity Analyses varied Main Scenario parameters singly; F from 0 to 0.4, X 0.01% to 15%, and Q and I 0.5 to 1.5. To allow comparison with prior work, individuals cannot be dual users, re-initiate, or switch except from cigarettes to e-cigarettes. RESULTS: Main Scenario reductions were 2.52 and 26.23 million deaths and life-years lost; Pessimistic Scenario reductions were 0.76 and 8.31 million. These were less than previously, due to the more limited age-range and follow-up, and restriction to four diseases. Reductions in deaths (millions) varied most for X, from 3.22 (X = 0.01%) to 1.31 (X = 15%), and F, 2.74 (F = 0) to 1.35 (F = 0.4). Varying Q or I had little effect. CONCLUSIONS: Substantial reductions in deaths and life-years lost were observed even under pessimistic assumptions. Estimates varied most for X and F. These findings supplement literature indicating e-cigarettes can importantly impact health challenges from smoking.

Building a Prevention System: Infrastructure to Strengthen Health Promotion Outcomes.

Prevention systems improve the performance of health promotion interventions. This research describes the establishment of the Australian state government initiative, Healthy Together Victoria's (HTV) macro infrastructure for the delivery of large-scale prevention interventions. METHODS: This paper reports on findings of 31 semi-structured interviews about participants' understanding of systems thinking and their reflections of the strengths and weaknesses of the HTV prevention system. A chronic disease prevention framework informed the coding that was used to create a causal loop diagram and a core feedback loop to illustrate the results. RESULTS: Findings highlighted that HTV created a highly connected prevention system that included a sizeable workforce, significant funding and supportive leadership. Operating guidelines, additional professional development and real-time evaluation were significant gaps, which hindered systems practice. For inexperienced systems thinkers, these limitations encouraged them to implement programs, rather than interact with the seemingly ambiguous systems methods. CONCLUSIONS: HTV was an innovative attempt to strengthen health promotion infrastructure, creating a common language and shared understanding of prevention system requirements. However, the model was inadequate for HTV to achieve population-level reductions in chronic disease as system oversight was missing, as was an intervention delivery focus. Clarity was needed to define the systems practice that HTV was seeking to achieve. Importantly, the HTV prevention system needed to be understood as complex and adaptive, and not prioritized as individual parts.

Characterization of Device-Related Malfunction, Injury, and Death Associated with Using Elastomeric Pumps for Delivery of Local Anesthetics in the US Food and Drug Administration MAUDE Database.

PURPOSE: To characterize medical device reports about elastomeric pumps delivering local anesthesia made to the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database. PATIENTS AND METHODS: We conducted a retrospective review of medical device reports submitted to MAUDE from January 2010 to July 2018. A systematic, computerized algorithm was used to identify records pertaining to elastomeric pumps using local anesthesia. Included records indicated the use of local anesthesia or were determined to involve the use of local anesthetics (if they did not contain specific information on drug use). Reports were analyzed within the MAUDE event type categories of malfunction, injury, death, other, and missing. Possible cases of liver injury or surgical site infection were also identified. Manual review of narratives provided in MAUDE was performed by 2 reviewers to identify possible or probable cases of local anesthetic system toxicity (LAST). RESULTS: From a pool of 384,285 reports about elastomeric pumps from the MAUDE database, 4093 met inclusion criteria for involving elastomeric pumps to deliver local anesthetics, with the peak number of reports occurring in 2014. Of these identified reports, 3624 (88.5%) were categorized as malfunctions, 292 (7.1%) as injuries, and 8 (0.2%) as involving death. We identified 13 cases (0.3%) of possible liver injury and 51 cases (1.2%) of possible surgical site infection; 139 reports (3.4%) were determined to be probably (n=53) or possibly (n=86) associated with LAST. CONCLUSION: Malfunction of elastomeric pumps delivering local anesthetics leaves patients vulnerable to injury or death. Our study indicates that reports of malfunction, injury, and death have been reported to the MAUDE database. These reports likely reflect an underrepresentation of cases in the real-world population, emphasizing the need for more comprehensive medical device reporting.

Changes in Interventional Pain Physician Decision-Making, Practice Patterns, and Mental Health During the Early Phase of the SARS-CoV-2 Global Pandemic.

BACKGROUND AND OBJECTIVES: The novel coronavirus outbreak (SARS-CoV-2) began in late 2019 and dramatically impacted health care systems. This study aimed to describe the impact of the early phase of the pandemic on physician decision-making, practice patterns, and mental health. METHODS: An anonymous survey was distributed to physician members of the Spine Intervention Society (SIS) on March 24 and April 7, 2020. Respondents provided information regarding changes in clinical volume, treatment, and mental health (Patient Health Questionnaire [PHQ-4]) before April 10, 2020. RESULTS: Of the 1,430 individuals who opened the survey, 260 completed it (18.2%). Overall clinical and procedural volume decreased to 69.6% and 13.0% of prepandemic volume, respectively. Mean in-person clinic visits were reduced to 17.7% of total prepandemic clinic volume. Ongoing clinical visits were predominantly completed via telemedicine (video) or telephone (74.5%), rather than in-person (25.5%). Telemedicine and telephone visits represented 24.6% and 27.3% of prepandemic clinical volume, respectively. Respondents decreased in-person visits of select groups of high-risk patients by 85.8-94.6%. Significantly more providers reported increasing rather than decreasing prescriptions of the following medications: opioids (28.8% vs 6.2% of providers, P < 0.001), muscle relaxants (22.3% vs 5.4%, P < 0.001), neuropathic pain medications (29.6% vs 3.8%, P < 0.001), and acetaminophen (26.2% vs 4.2%, P < 0.001). Respondents' mean PHQ-4 score was 3.1, with 19% reporting moderate or severe psychological distress. Several demographic factors were significantly associated with practice changes. CONCLUSIONS: The novel coronavirus pandemic dramatically altered the practice and prescribing patterns of interventional pain physicians.

Independent Validation in a Large Privately Insured Population of the Risk Index for Serious Prescription Opioid-Induced Respiratory Depression or Overdose.

OBJECTIVE: To assess the generalizability of the overdose or serious opioid-induced respiratory depression risk index (VHA-RIOSORD), created by Zedler et al., using claims data from a large private insurer. DESIGN: A retrospective nested case-control analysis of health care claims data. SUBJECTS: Commercially insured individuals with a claim for an opioid prescription between October 1, 2014, and September 30, 2016 (N = 1,431,737). METHODS: An overdose or serious opioid-induced respiratory depression (OSORD) occurred in 1,097 patients. Ten controls were selected per case (N = 10,970). Items and the assignment of point values to predictors were consistent with those determined by Zedler et al. Modeling of risk index scores produced predicted probabilities of OSORD; risk classes were defined by the predicted probability distribution. RESULTS: All 15 items of the VHA-RIOSORD were used to determine a member's risk of OSORD. The average predicted probability of experiencing OSORD ranged from 3% in the lowest risk decile to 90% in the highest, with excellent agreement between predicted and observed incidence across risk classes. The model's C-statistic was 0.88. CONCLUSIONS: Consistent with the findings of its developers, the VHA-RIOSORD performed well in identifying members of a large private insurance company who were medical users of prescription opioids at elevated risk of overdose or life-threatening respiratory depression, those most likely to benefit from preventive interventions.

Validation of an administrative claims coding algorithm for serious opioid overdose: A medical chart review.

PURPOSE: A standardized definition for serious opioid overdose has not been clearly established for disease surveillance or assessing the impact of risk mitigation strategies. The purpose of this study was to use medical chart review to clinically validate a claims-based algorithm to identify serious opioid overdose events. METHODS: The algorithm for serious opioid overdose required an opioid poisoning or external cause ICD-9-CM code occurring within 1 day of (a) an adverse effect code for serious central nervous system or respiratory depression or (b) a mechanical ventilation or critical care CPT code. The claims coding algorithm identified a sample of 145 individuals 18 years or older among patients that presented to the emergency department of two large hospitals in metropolitan Atlanta, Georgia from January 2014 to August 2015. Claims-defined cases were evaluated against rigorous clinical definitions for serious opioid overdose using (a) literature-based criteria for typical clinical manifestations of opioid overdose and/or (b) clinical response to the opioid-specific reversal agent naloxone. The positive predictive value (PPV) for a serious opioid overdose was calculated as the percentage of clinically confirmed cases (definite or probable). RESULTS: Among 140 evaluable claims-defined cases, 107 fulfilled clinical criteria for a serious opioid overdose [95 definite and 12 probable; PPV of 76.4% (95% CI 69.4%, 83.5%)]. Among 30 nonconfirmed cases, 20 were polyintoxications involving one or more nonopioid psychoactive agents. CONCLUSIONS: An administrative claims coding algorithm for serious opioid overdose had high clinical predictive performance in a medical chart review.

Atlanto-axial Pannus in Patients with and without Rheumatoid Arthritis.

OBJECTIVE: Pannus formation in the atlanto-axial joint is a well-recognized complication of rheumatoid arthritis (RA). Occasionally, atlanto-axial pannus is reported when patients without a history of RA undergo magnetic resonance imaging (MRI) of the cervical spine. We sought to further characterize these patients. METHODS: The Partners HealthCare Research Patient Data Registry was free-text searched for "atlanto-axial" AND "pannus" in cervical spine MRI reports from 2001 to 2015. Cases with MRI reports describing pannus were reviewed. Clinical data were extracted by chart review in cases with confirmed atlanto-axial pannus (n = 105). RESULTS: Twenty-nine patients (27.6%) had RA, all of whom except one carried this diagnosis at the time of the MRI scan. Only 1 of 77 patients without a history of RA was subsequently diagnosed with RA (1.3%, 95% CI 0.1-7.0%, median followup 3.6 yrs). Non-RA patients were significantly older (median age 79 vs 63 yrs, p < 0.0001), less frequently female (55% vs 86%, p = 0.0032), and more likely to have undergone prior cervical spine surgery (18% vs 0%, p = 0.016) compared with RA patients. Thirty-four non-RA patients (44.7%) either had a clinical diagnosis of calcium pyrophosphate dihydrate disease (CPPD) or imaging evidence for tissue calcification. There were no significant differences in age or sex between the CPPD subgroup and other non-RA patients. Twenty-eight patients (26.7%) underwent cervical spine surgery. CONCLUSION: Patients without RA diagnosis and incidental atlanto-axial pannus on cervical spine MRI are unlikely to have previously unrecognized RA. Degenerative disease and tissue calcification may contribute to pannus formation in these patients.

Alignment and political will: upscaling an Australian respectful relationships program.

Many small scale efficacious programs and interventions need to be 'scaled-up' in order to reach a larger population. Although it has been argued that interventions deemed suitable for upscaling need to have demonstrated effectiveness, be able to be implemented cost-effectively and be accepted by intended recipients, these factors alone are insufficient in explaining which programs are adopted more broadly. Upscaling research often identifies political will as a key factor in explaining whether programs are supported and up-scaled, but this research lacks any depth into how political will is formed and has not applied policy theories to understanding the upscaling process. This article uses a political science lens to examine the key factors in the upscaling process of a Respectful Relationships in Schools Program. Focus groups and interviews were conducted with project staff, managers and community organizations involved in the program. The results reveal how a key focusing event related to a highly profiled personal tragedy propelled family violence into the national spotlight. At the same time, the organization leading the respectful relationships program leveraged their networks to position the program within the education department which enabled the government to quickly respond to the issue. The study highlights that political will is not a stand-alone factor as depicted by up-scaling models, but rather is the end point of a complex process that involves many elements including the establishment of networks and aligned programs that can capitalize when opportunities arise.

The influence of contextual factors on implementation fidelity in a whole school approach to prevention of violence against women.

ISSUE ADDRESSED: Implementation fidelity relates to the degree of adherence to implementation protocols and content and helps to guide replication of evidence-based programs. In settings-based research, notions of fidelity have been applied more often to delivery of education content rather than whole of setting change. The aims of this paper were firstly, to analyse how contextual factors influenced implementation of a whole school program on respectful relationships education, and secondly given the findings, discuss whether a more flexible approach to implementation fidelity may have yielded increased school engagement. METHODS: The project was conducted in 19 secondary schools in Victoria in 2015. This paper reports on focus groups and interviews which were conducted with 81 school staff and 28 staff from the lead agency, community agency partners, and departmental staff to understand the contextual factors influencing implementation. RESULTS: The program followed a traditional implementation fidelity approach of considering core elements and some minor scope for adaption which engaged some regions and schools but not others. CONCLUSION: An alternative notion of implementation fidelity, "fidelity to function," may have permitted increased flexibility to tailor the intervention components to suit different school and community contexts and potentially, increasing both the reach and impact of the program. SO WHAT?: Understanding how to apply notions of fidelity to guide whole of setting change are important considerations if programs are to be replicated to have wider reach and greater impact and effectiveness.

Neuropilins guide preganglionic sympathetic axons and chromaffin cell precursors to establish the adrenal medulla.

The adrenal medulla is composed of neuroendocrine chromaffin cells that secrete adrenaline into the systemic circulation to maintain physiological homeostasis and enable the autonomic stress response. How chromaffin cell precursors colonise the adrenal medulla and how they become connected to central nervous system-derived preganglionic sympathetic neurons remain largely unknown. By combining lineage tracing, gene expression studies, genetic ablation and the analysis of mouse mutants, we demonstrate that preganglionic axons direct chromaffin cell precursors into the adrenal primordia. We further show that preganglionic axons and chromaffin cell precursors require class 3 semaphorin (SEMA3) signalling through neuropilins (NRP) to target the adrenal medulla. Thus, SEMA3 proteins serve as guidance cues to control formation of the adrenal neuroendocrine system by establishing appropriate connections between preganglionic neurons and adrenal chromaffin cells that regulate the autonomic stress response.

A comparison of approaches to identify possible cases of local anesthetic systemic toxicity in the FDA Adverse Event Reporting System (FAERS) database.

BACKGROUND: Local anesthetic systemic toxicity (LAST) is a rare but potentially serious adverse event . METHODS: Data from the US Food and Drug Administration Adverse Event Reporting System were examined for liposomal bupivacaine (LB), bupivacaine, or other injectable local anesthetics. Possible LAST cases were identified based on MedDRA system organ classes (Approach 1), a recent publication (Approach 2), and a novel approach based on LAST literature (Approach 3). Disproportionality analyses compared possible LAST cases for LB and bupivacaine with other injectable local anesthetics. RESULTS: Approaches 1, 2, and 3 identified 75, 42, and 29 possible LAST cases associated with LB, respectively, compared with 9,595, 3,422, and 549 for other injectable local anesthetics. The proportional reporting ratios (95% CI) for LB versus other injectable local anesthetics for the 3 approaches were 1.9 (1.6-2.3), 2.9 (2.2-3.9), and 1.6 (1.1-2.2), respectively. Based on sales data, the estimated incidence of possible LAST with LB was 0.1 per 10,000 uses; literature estimates for LAST with other injectable local anesthetics were 0 to 18 per 10,000 uses. CONCLUSIONS: Our findings suggest the estimated incidence of possible LAST cases with LB is similar to, or less than, the reported incidence with other injectable local anesthetics.

Validation of a Screening Risk Index for Serious Prescription Opioid-Induced Respiratory Depression or Overdose in a US Commercial Health Plan Claims Database.

Objective: To validate a risk index that estimates the likelihood of overdose or serious opioid-induced respiratory depression (OIRD) among medical users of prescription opioids. Subjects and Methods: A case-control analysis of 18,365,497 patients with an opioid prescription from 2009 to 2013 in the IMS PharMetrics Plus commercially insured health plan claims database (CIP). An OIRD event occurred in 7,234 cases. Four controls were selected per case. Validity of the Risk Index for Overdose or Serious Opioid-induced Respiratory Depression (RIOSORD), developed previously using Veterans Health Administration (VHA) patient data, was assessed. Multivariable logistic regression was used within the CIP study population to develop a slightly refined RIOSORD. The composition and performance of the CIP-based RIOSORD was evaluated and compared with VHA-based RIOSORD. Results: VHA-RIOSORD performed well in discriminating OIRD events in CIP (C-statistic = 0.85). Additionally, re-estimation of logistic model coefficients in CIP yielded a 0.90 C-statistic. The resulting comorbidity and pharmacotherapy variables most highly associated with OIRD and retained in the CIP-RIOSORD were largely concordant with VHA-RIOSORD. These variables included neuropsychiatric and cardiopulmonary disorders, impaired drug excretion, opioid characteristics, and concurrent psychoactive medications. The average predicted probability of OIRD ranged from 2% to 83%, with excellent agreement between predicted and observed incidence across risk classes. Conclusions: RIOSORD had excellent predictive accuracy in a large population of US medical users of prescription opioids, similar to its performance in VHA. This practical risk index is designed to support clinical decision-making for safer opioid prescribing, and its clinical utility should be evaluated prospectively.

Risk Factors for Serious Prescription Opioid-Induced Respiratory Depression or Overdose: Comparison of Commercially Insured and Veterans Health Affairs Populations.

Objective: To characterize the risk factors associated with overdose or serious opioid-induced respiratory depression (OIRD) among medical users of prescription opioids in a commercially insured population (CIP) and to compare risk factor profiles between the CIP and Veterans Health Administration (VHA) population. Subjects and Methods: Analysis of data from 18,365,497 patients in the IMS PharMetrics Plus health plan claims database (CIP) who were dispensed a prescription opioid in 2009 to 2013. Baseline factors associated with an event of serious OIRD among 7,234 cases and 28,932 controls were identified using multivariable logistic regression. The CIP risk factor profile was compared with that from a corresponding logistic regression among 817 VHA cases and 8,170 controls in 2010 to 2012. Results: The strongest associations with serious OIRD in CIP were diagnosed substance use disorder (odds ratio [OR] = 10.20, 95% confidence interval [CI] = 9.06-11.40) and depression (OR = 3.12, 95% CI = 2.84-3.42). Other strongly associated factors included other mental health disorders; impaired liver, renal, vascular, and pulmonary function; prescribed fentanyl, methadone, and morphine; higher daily opioid doses; and concurrent psychoactive medications. These risk factors, except depression, vascular disease, and specific opioids, largely aligned with VHA despite CIP being substantially younger, including more females and less chronic disease, and having greater prescribing prevalence of higher daily opioid doses, specific opioids, and most selected nonopioids. Conclusions: Risk factor profiles for serious OIRD among US medical users of prescription opioids with private or public health insurance were largely concordant despite substantial differences between the populations in demographics, clinical conditions, health care delivery systems, and clinical practices.