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Item The Challenges of Conducting Intrastate Policy Surveillance: A Methods Note on County and City Laws in Indiana(APHA, 2021-06) Sanner, Lindsey; Grant, Sean; Walter-McCabe, Heather; Silverman, Ross D.; Social and Behavioral Sciences, School of Public HealthPolicy surveillance is critical in examining the ways law functions as a structural and social determinant of health. To date, little policy surveillance research has focused on examining intrastate variations in the structure and health impact of laws. Intrastate policy surveillance poses unique methodological challenges because of the complex legal architecture within states and inefficient curation of local laws. We discuss our experience with these intrastate policy surveillance challenges in Indiana, a state with 92 counties and several populous cities, a complicated history of home rule, systemically underfunded local governments, and variations in demography, geography, and technology adoption. In our case study, we expended significant time and resources to obtain county and city ordinances through online code libraries, jurisdiction Web sites, and (most notably) visits to offices to scan documents ourselves. A concerted effort is needed to ensure that local laws of all kinds are stored online in organized, searchable, and open access systems. Such an effort is vital to achieve the aspirational goals of policy surveillance at the intrastate level.Item Clearinghouse Standards of Evidence on the Transparency, Openness, and Reproducibility of Intervention Evaluations(Springer, 2021) Mayo-Wilson, Evan; Grant, Sean; Supplee, Lauren H.; Epidemiology, Richard M. Fairbanks School of Public HealthClearinghouses are influential repositories of information on the effectiveness of social interventions. To identify which interventions are “evidence-based,” clearinghouses review intervention evaluations using published standards of evidence that focus primarily on internal validity and causal inferences. Open science practices can improve trust in evidence from evaluations on the effectiveness of social interventions. Including open science practices in clearinghouse standards of evidence is one of many efforts that could increase confidence in designations of interventions as “evidence-based.” In this study, we examined the policies, procedures, and practices of 10 federal evidence clearinghouses that review preventive interventions—an important and influential subset of all evidence clearinghouses. We found that seven consider at least one open science practice when evaluating interventions: replication (6 of 10 clearinghouses), public availability of results (6), investigator conflicts of interest (3), design and analysis transparency (3), study registration (2), and protocol sharing (1). We did not identify any policies, procedures, or practices related to analysis plan registration, data sharing, code sharing, material sharing, and citation standards. We provide a framework with specific recommendations to help federal and other evidence clearinghouses implement the Transparency and Openness Promotion (TOP) Guidelines. Our proposed “TOP Guidelines for Clearinghouses” includes reporting whether evaluations used open science practices, incorporating open science practices in their standards for receiving “evidence-based” designations, and verifying that evaluations used open science practices. Doing so could increase the trustworthiness of evidence used for policy making and support improvements throughout the evidence ecosystem.Item Clinical interventions for adults with comorbid alcohol use and depressive disorders: A systematic review and network meta-analysis(Public Library of Science, 2021-10) Grant, Sean; Azhar, Gulrez; Han, Eugeniu; Booth, Marika; Motala, Aneesa; Larkin, Jody; Hempel, Susanne; Epidemiology, Richard M. Fairbanks School of Public HealthBackground: Uncertainty remains regarding the effectiveness of treatments for patients diagnosed with both an alcohol use disorder (AUD) and depressive disorder. This study aimed to compare the effectiveness of clinical interventions for improving symptoms of adults with co-occurring AUDs and depressive disorders. Methods and findings: We searched CINAHL, ClinicalTrials.gov, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, Excerpta Medica Database, International Clinical Trials Registry Platform (ICTRP), PubMed, PsycINFO, and Web of Science from inception to December 2020. We included randomized controlled trials (RCTs) evaluating clinical interventions for adults with co-occurring AUDs and depressive disorders. Two independent reviewers extracted study-level information and outcome data. We assessed risk of bias using the Cochrane Risk of Bias tool, used frequentist random effects models for network meta-analyses, and rated our confidence in effect estimates using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach. Primary outcomes were remission from depression and alcohol use. Secondary outcomes were depressive symptoms, alcohol use, heavy drinking, health-related quality of life, functional status, and adverse events. We used standardized mean differences (SMDs) for continuous outcomes and odds ratios (ORs) for dichotomous outcomes to estimate intervention effects. Overall, 36 RCTs with 2,729 participants evaluated 14 pharmacological and 4 psychological interventions adjunctive to treatment as usual (TAU). Studies were published from 1971 to 2019, conducted in 13 countries, and had a median sample size of 50 participants (range: 14 to 350 participants). We have very low confidence in all estimates of intervention effects on our primary outcomes (i.e., remission from depression and remission from alcohol use). We have moderate confidence that cognitive behavioral therapies (CBTs) demonstrated greater benefit than no additional treatment (SMD = -0.84; 95% confidence interval [CI], -1.05 to -0.63; p < 0.001) for depressive symptoms and low confidence (SMD = -0.25; 95% CI, -0.47 to -0.04; p = 0.021) for alcohol use. We have low confidence that tricyclic antidepressants (TCAs) demonstrated greater benefit than placebo (SMD = -0.37; 95% CI, -0.72 to -0.02, p = 0.038) for depressive symptoms. Compared with placebo, we have moderate confidence that selective serotonin reuptake inhibitors (SSRIs) demonstrated greater benefit for functional status (SMD = -0.92; 95% CI, -1.36 to -0.47, p < 0.001) and low confidence for alcohol use (SMD = -0.30; 95% CI, -0.59 to -0.02, p = 0.039). However, we have moderate confidence that patients receiving SSRIs also were more likely to experience an adverse event (OR = 2.20; 95% CI, 0.94 to 5.16, p = 0.07). We have very low confidence in all other effect estimates, and we did not have high confidence in any effect estimates. Limitations include the sparsity of evidence on intervention effects over the long term, risks of attrition bias, and heterogeneous definitions of adverse events in the evidence base. Conclusions: We are very uncertain about the existence (or not) of any non-null effects for our primary outcomes of remission from depression and remission from alcohol use. The available evidence does suggest that CBTs likely reduced, and TCAs may have resulted in a slight reduction of depressive symptoms. SSRIs likely increased functional status, and SSRIs and CBTs may have resulted in a slight reduction of alcohol use. However, patients receiving SSRIs also likely had an increased risk of experiencing an adverse event. In addition, these conclusions only apply to postintervention and are not against active comparators, limiting the understanding of the efficacy of interventions in the long term as well as the comparative effectiveness of active treatments. As we did not have high confidence in any outcomes, additional studies are warranted to provide more conclusive evidence.Item Effectiveness and implementability of state-level naloxone access policies: Expert consensus from an online modified-Delphi process(Elsevier, 2021) Smart, Rosanna; Grant, Sean; Social and Behavioral Sciences, School of Public HealthBackground: Naloxone distribution, a key global strategy to prevent fatal opioid overdose, has been a recent target of legislation in the U.S., but there is insufficient empirical evidence from causal inference methods to identify which components of these policies successfully reduce opioid-related harms. This study aimed to examine expert consensus on the effectiveness and implementability of various state-level naloxone policies. Methods: We used the online ExpertLens platform to conduct a three-round modified-Delphi process with a purposive sample of 46 key stakeholders (advocates, healthcare providers, human/social service practitioners, policymakers, and researchers) with naloxone policy expertise. The Effectiveness Panel (n = 24) rated average effects of 15 types of policies on naloxone pharmacy distribution, opioid use disorder (OUD) prevalence, nonfatal opioid-related overdoses, and opioid-related overdose mortality. The Implementation Panel (n = 22) rated the same policies on acceptability, feasibility, affordability, and equitability. We compared ratings across policies using medians and inter-percentile ranges, with consensus measured using the RAND/UCLA Appropriateness Method Inter-Percentile Range Adjusted for Symmetry technique. Results: Experts reached consensus on all items. Except for liability protections and required provision of education or training, experts perceived all policies to generate moderate-to-large increases in naloxone pharmacy distribution. However, only three policies were expected to yield substantive decreases on fatal overdose: statewide standing/protocol order, over-the-counter supply, and statewide "free naloxone." Of these, experts rated only statewide standing/protocol orders as highly affordable and equitable, and unlikely to generate meaningful population-level effects on OUD or nonfatal opioid-related overdose. Across all policies, experts rated naloxone prescribing mandates relatively lower in acceptability, feasibility, affordability, and equitability. Conclusion: Experts believe statewide standing/protocol orders are an effective, implementable, and equitable policy for addressing opioid-related overdose mortality. While experts believe many other broad policies are effective in reducing opioid-related harms, they also believe these policies face implementation challenges related to cost and reaching vulnerable populations.Item Expert Panel Consensus on State-Level Policies to Improve Engagement and Retention in Treatment for Opioid Use Disord(American Medical Association, 2022-09-02) Smart, Rosanna; Grant, Sean; Gordon, Adam J.; Pacula, Rosalie Liccardo; Stein, Bradley D.; Social and Behavioral Sciences, School of Public HealthImportance: In the US, recent legislation and regulations have been considered, proposed, and implemented to improve the quality of treatment for opioid use disorder (OUD). However, insufficient empirical evidence exists to identify which policies are feasible to implement and successfully improve patient and population-level outcomes. Objective: To examine expert consensus on the effectiveness and the ability to implement state-level OUD treatment policies. Evidence review: This qualitative study used the ExpertLens online platform to conduct a 3-round modified Delphi process to convene 66 stakeholders (health care clinicians, social service practitioners, addiction researchers, health policy decision-makers, policy advocates, and persons with lived experience). Stakeholders participated in 1 of 2 expert panels on 14 hypothetical state-level policies targeting treatment engagement and linkage, evidence-based and integrated care, treatment flexibility, and monitoring or support services. Participants rated policies in round 1, discussed results in round 2, and provided final ratings in round 3. Participants used 4 criteria associated with either the effectiveness or implementability to rate and discuss each policy. The effectiveness panel (n = 29) considered policy effects on treatment engagement, treatment retention, OUD remission, and opioid overdose mortality. The implementation panel (n = 34) considered the acceptability, feasibility, affordability, and equitability of each policy. We measured consensus using the interpercentile range adjusted for symmetry analysis technique from the RAND/UCLA appropriateness method. Findings: Both panels reached consensus on all items. Experts viewed 2 policies (facilitated access to medications for OUD and automatic Medicaid enrollment for citizens returning from correctional settings) as highly implementable and highly effective in improving patient and population-level outcomes. Participants rated hub-and-spoke-type policies and provision of financial incentives to emergency departments for treatment linkage as effective; however, they also rated these policies as facing implementation barriers associated with feasibility and affordability. Coercive policies and policies levying additional requirements on individuals with OUD receiving treatment (eg, drug toxicology testing, counseling requirements) were viewed as low-value policies (ie, decreasing treatment engagement and retention, increasing overdose mortality, and increasing health inequities). Conclusions and relevance: The findings of this study may provide urgently needed consensus on policies for states to consider either adopting or deimplementing in their efforts to address the opioid overdose crisis.Item Expert views on state-level naloxone access laws: a qualitative analysis of an online modified-Delphi process(BMC, 2022-06-08) Grant, Sean; Smart, Rosanna; Social and Behavioral Sciences, School of Public HealthBackground: Expanding availability to naloxone is a core harm reduction strategy in efforts to address the opioid epidemic. In the US, state-level legislation is a prominent mechanism to expand naloxone availability through various venues, such as community pharmacies. This qualitative study aimed to identify and summarize the views of experts on state-level naloxone access laws. Methods: We conducted a three-round modified-Delphi process using the online ExpertLens platform. Participants included 46 key stakeholders representing various groups (advocates, healthcare providers, human/social service practitioners, policymakers, and researchers) with expertise naloxone access laws. Participants commented on the effectiveness and implementability of 15 state-level naloxone access laws (NALs). We thematically analyzed participant comments to summarize views on NALs overall and specific types of NAL. Results: Participants commented that the effectiveness of NALs in reducing opioid-related mortality depends on their ability to make sustained, significant impacts on population-level naloxone availability. Participants generally believed that increased naloxone availability does not have appreciable negative impacts on the prevalence of opioid misuse, opioid use disorder (OUD), and non-fatal opioid overdoses. Implementation barriers include stigma among the general public, affordability of naloxone, and reliance on an inequitable healthcare system. Conclusions: Experts believe NALs that significantly increase naloxone access are associated with less overdose mortality without risking substantial unintended public health outcomes. To maximize impacts, high-value NALs should explicitly counter existing healthcare system inequities, address stigmatization of opioid use and naloxone, maintain reasonable prices for purchasing naloxone, and target settings beyond community pharmacies to distribute naloxone.Item A Framework for Open Policy Analysis(2018) de la Guardia, Fernando Hoces; Grant, Sean; Miguel, Edward; Social and Behavioral Sciences, School of Public HealthThe evidence-based policy movement promotes the use of empirical evidence to inform policy decision-making. While several social science disciplines are undergoing a “credibility revolution” focused on openness and replication, policy analysis has yet to systematically embrace transparency and reproducibility. We argue that policy analysis should adopt the open research practices increasingly espoused in related disciplines to advance the credibility of evidence-based policymaking. We first discuss the importance of evidence-based policy in an era of increasing disagreement about facts, analysis, and expertise. We present a novel framework for “open” policy analysis (OPA) and how to achieve it, focusing on examples of recent policy analyses that have incorporated open research practices such as transparent reporting, open data, and code sharing. We conclude with recommendations on how key stakeholders in evidence-based policy can make OPA the norm and thus safeguard trust in using empirical evidence to inform important public policy decisions.Item Identifying optimal level-of-care placement decisions for adolescent substance use treatment(Elsevier, 2020-07) Agniel, Denis; Almirall, Daniel; Burkhart, Q.; Grant, Sean; Hunter, Sarah B.; Pedersen, Eric R.; Ramchand, Rajeev; Griffin, Beth Ann; Social and Behavioral Sciences, School of Public HealthBackground: Adolescents respond differentially to substance use treatment based on their individual needs and goals. Providers may benefit from guidance (via decision rules) for personalizing aspects of treatment, such as level-of-care (LOC) placements, like choosing between outpatient or inpatient care. The field lacks an empirically-supported foundation to inform the development of an adaptive LOC-placement protocol. This work begins to build the evidence base for adaptive protocols by estimating them from a large observational dataset. Methods: We estimated two-stage LOC-placement protocols adapted to individual adolescent characteristics collected from the Global Appraisal of Individual Needs assessment tool (n = 10,131 adolescents). We used a modified version of Q-learning, a regression-based method for estimating personalized treatment rules over time, to estimate four protocols, each targeting a potentially distinct treatment goal: one primary outcome (a composite of ten positive treatment outcomes) and three secondary (substance frequency, substance problems, and emotional problems). We compared the adaptive protocols to non-adaptive protocols using an independent dataset. Results: Intensive outpatient was recommended for all adolescents at intake for the primary outcome, while low-risk adolescents were recommended for no further treatment at followup while higher-risk patients were recommended to inpatient. Our adaptive protocols outperformed static protocols by an average of 0.4 standard deviations (95 % confidence interval 0.2-0.6) of the primary outcome. Conclusions: Adaptive protocols provide a simple one-to-one guide between adolescents' needs and recommended treatment which can be used as decision support for clinicians making LOC-placement decisions.Item Online Modified-Delphi: a Potential Method for Continuous Patient Engagement Across Stages of Clinical Practice Guideline Development(Springer, 2021) Grant, Sean; Armstrong, Courtney; Khodyakov, Dmitry; Social and Behavioral Sciences, School of Public HealthItem Opinion: Why institutional review boards should have a role in the open science movement(National Academy of Sciences, 2019-10-22) Grant, Sean; Bouskill, Kathryn E.; Social and Behavioral Sciences, School of Public Health
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