Enrollment, retention, and strategies for including disadvantaged populations in randomized controlled trials: a systematic review protocol.

BACKGROUND: Many randomized controlled trials fail to reach their target sample size. When coupled with the omission and underrepresentation of disadvantaged groups in randomized controlled trials, many trials fail to obtain data that accurately represents the true diversity of their target population. Policies and practices have been implemented to increase representation of disadvantaged groups in many randomized controlled trials, with some trials specifically targeting such groups. To our knowledge, no systematic review has quantified the enrollment metrics and effectiveness of inclusion and retention strategies in randomized controlled trials focused on disadvantaged populations specifically. METHODS: We will conduct a systematic search across EMBASE, MEDLINE, Web of Science, and CINAHL as well as grey literature, conference proceedings, research monographs, and Google Scholar from inception onwards. We will include randomized controlled trials where at least 50% of enrolled participants are considered to be disadvantaged, as per the RCT authors' definition and in line with our inclusion criteria. Two independent researchers per article will conduct preliminary title and abstract screening, subsequent full text review, and data extraction for the selected trials, with a third reviewer available to resolve conflicts. We will assess the quality of all included studies using specific criteria regarding data reporting, external validity, and internal validity. We will combine all selected studies and conduct a narrative synthesis to assess enrollment metrics. If there is sufficient homogeneity and sufficient trials comparing recruitment strategies within disadvantaged populations, we will conduct a random effects meta-analysis to evaluate the effectiveness of strategies designed to maximize the inclusion of disadvantaged populations in randomized controlled trials. DISCUSSION: The findings of this systematic review will establish baseline recruitment and enrollment metrics of trials targeting disadvantaged populations to elucidate the scope of the challenge of recruiting such populations. We hope that our findings will promote future research on the distinct barriers that may prevent disadvantaged populations from participating in health intervention research, will encourage more trials exploring effective, tailored recruitment strategies, and will establish a foundation to track future progress in the recruitment of disadvantaged populations. TRIAL REGISTRATIONS: PROSPERO ID: CRD42020152814.

Separating the Wheat from the Chaff: Comparative Visual Cues for Transparent Diagnostics of Competing Models.

Experts in data and physical sciences have to regularly grapple with the problem of competing models. Be it analytical or physics-based models, a cross-cutting challenge for experts is to reliably diagnose which model outcomes appropriately predict or simulate real-world phenomena. Expert judgment involves reconciling information across many, and often, conflicting criteria that describe the quality of model outcomes. In this paper, through a design study with climate scientists, we develop a deeper understanding of the problem and solution space of model diagnostics, resulting in the following contributions: i) a problem and task characterization using which we map experts' model diagnostics goals to multi-way visual comparison tasks, ii) a design space of comparative visual cues for letting experts quickly understand the degree of disagreement among competing models and gauge the degree of stability of model outputs with respect to alternative criteria, and iii) design and evaluation of MyriadCues, an interactive visualization interface for exploring alternative hypotheses and insights about good and bad models by leveraging comparative visual cues. We present case studies and subjective feedback by experts, which validate how MyriadCues enables more transparent model diagnostic mechanisms, as compared to the state of the art.

Implementation of the uterine fibroids Option Grid patient decision aids across five organizational settings: a randomized stepped-wedge study protocol.

BACKGROUND: Uterine fibroids are non-cancerous overgrowths of the smooth muscle in the uterus. As they grow, some cause problems such as heavy menstrual bleeding, pelvic pain, discomfort during sexual intercourse, and rarely pregnancy complications or difficulty becoming pregnant. Multiple treatment options are available. The lack of comparative evidence demonstrating superiority of any one treatment means that choosing the best option is sensitive to individual preferences. Women with fibroids wish to consider treatment trade-offs. Tools known as patient decision aids (PDAs) are effective in increasing patient engagement in the decision-making process. However, the implementation of PDAs in routine care remains challenging. Our aim is to use a multi-component implementation strategy to implement the uterine fibroids Option Grid™ PDAs at five organizational settings in the USA. METHODS: We will conduct a randomized stepped-wedge implementation study where five sites will be randomized to implement the uterine fibroid Option Grid PDA in practice at different time points. Implementation will be guided by the Consolidated Framework for Implementation Research (CFIR) and Normalization Process Theory (NPT). There will be a 6-month pre-implementation phase, a 2-month initiation phase where participating clinicians will receive training and be introduced to the Option Grid PDAs (available in text, picture, or online formats), and a 6-month active implementation phase where clinicians will be expected to use the PDAs with patients who are assigned female sex at birth, are at least 18 years of age, speak fluent English or Spanish, and have new or recurrent symptoms of uterine fibroids. We will exclude postmenopausal patients. Our primary outcome measure is the number of eligible patients who receive the Option Grid PDAs. We will use logistic and linear regression analyses to compare binary and continuous quantitative outcome measures (including survey scores and Option Grid use) between the pre- and active implementation phases while adjusting for patient and clinician characteristics. DISCUSSION: This study may help identify the factors that impact the implementation and sustained use of a PDA in clinic workflow from various stakeholder perspectives while helping patients with uterine fibroids make treatment decisions that align with their preferences. TRIAL REGISTRATION: Clinicaltrials.gov , NCT03985449. Registered 13 July 2019, https://clinicaltrials.gov/ct2/show/NCT03985449.

Demonstrating the financial impact of clinical libraries: a systematic review.

OBJECTIVE: The purpose of this review is to evaluate the tools used to measure the financial value of libraries in a clinical setting. METHODS: Searches were carried out on ten databases for the years 2003-2013, with a final search before completion to identify any recent papers. RESULTS: Eleven papers met the final inclusion criteria. There was no evidence of a single 'best practice', and many metrics used to measure financial impact of clinical libraries were developed on an ad hoc basis locally. The most common measures of financial impact were value of time saved, value of resource collection against cost of alternative sources, cost avoidance and revenue generated through assistance on grant submissions. Few papers provided an insight into the longer term impact on the library service resulting from submitting return on investment (ROI) or other financial impact statements. CONCLUSIONS: There are limited examples of metrics which clinical libraries can use to measure explicit financial impact. The methods highlighted in this literature review are generally implicit in the measures used and lack robustness. There is a need for future research to develop standardised, validated tools that clinical libraries can use to demonstrate their financial impact.

Predictors of outcome for short-term medically supervised opioid withdrawal during a randomized, multicenter trial of buprenorphine-naloxone and clonidine in the NIDA clinical trials network drug and alcohol dependence.

Few studies in community settings have evaluated predictors, mediators, and moderators of treatment success for medically supervised opioid withdrawal treatment. This report presents new findings about these factors from a study of 344 opioid-dependent men and women prospectively randomized to either buprenorphine-naloxone or clonidine in an open-label 13-day medically supervised withdrawal study. Subjects were either inpatient or outpatient in community treatment settings; however not randomized by treatment setting. Medication type (buprenorphine-naloxone versus clonidine) was the single best predictor of treatment retention and treatment success, regardless of treatment setting. Compared to the outpatient setting, the inpatient setting was associated with higher abstinence rates but similar retention rates when adjusting for medication type. Early opioid withdrawal severity mediated the relationship between medication type and treatment outcome with buprenorphine-naloxone being superior to clonidine at relieving early withdrawal symptoms. Inpatient subjects on clonidine with lower withdrawal scores at baseline did better than those with higher withdrawal scores; inpatient subjects receiving buprenorphine-naloxone did better with higher withdrawal scores at baseline than those with lower withdrawal scores. No relationship was found between treatment outcome and age, gender, race, education, employment, marital status, legal problems, baseline depression, or length/severity of drug use. Tobacco use was associated with worse opioid treatment outcomes. Severe baseline anxiety symptoms doubled treatment success. Medication type (buprenorphine-naloxone) was the most important predictor of positive outcome; however the paper also considers other clinical and policy implications of other results, including that inpatient setting predicted better outcomes and moderated medication outcomes.

Prevalence of in-service and post-service sexual assault among combat and noncombat veterans applying for Department of Veterans Affairs posttraumatic stress disorder disability benefits.

OBJECTIVE: To describe the prevalence of in-service and post-service sexual assault among combat and noncombat veterans seeking Veteran's Affairs disability benefits for posttraumatic stress disorder (PTSD). METHODS: Cross-sectional survey of 4,918 veterans. RESULTS: Surveys were returned by 3,337 veterans (effective response rate, 68%). Among men, 6.5% of combat veterans and 16.5% of noncombat veterans reported in-service or post-service sexual assault. Among women, 69% of combat veterans and 86.6% of noncombat veterans reported in-service or post-service sexual assault. CONCLUSIONS: Reported rates of sexual assault were considerably higher among veterans seeking Veteran's Affairs disability benefits for PTSD than historically reported rates for men and women in the general population. In this population, male gender and veterans' combat status should not dissuade clinicians from screening for sexual traumas.

Gender Differences in service connection for PTSD.

BACKGROUND: Mentally ill female veterans obtain a smaller proportion of their care from Department of Veterans Affairs (VA) facilities than mentally ill male veterans do, possibly because women are less likely than men to be service connected for psychiatric disabilities. "Service connected" veterans have documented, compensative conditions related to or aggravated by military service, and they receive priority for enrollment into the VA healthcare system. OBJECTIVES: To see if there are gender discrepancies in rates of service connection for posttraumatic stress disorder (PTSD) and, if so, to see if these discrepancies could be attributed to appropriate subject characteristics (eg, differences in symptom severity or impairment). RESEARCH DESIGN: Mailed survey linked to administrative data. Claims audits were conducted on 11% of the sample. SUBJECTS: Randomly selected veterans seeking VA disability benefits for PTSD. Women were oversampled to achieve a gender ratio of 1:1. RESULTS: A total of 3337 veterans returned usable surveys (effective response rate, 68%). Men's unadjusted rate of service connection for PTSD was 71%; women's, 52% (P < 0.0001). Adjustment for veterans' PTSD symptom severity or functional impairment did not appreciably reduce this discrepancy, but adjustment for dissimilar rates of combat exposure did. Estimated rates of service connection were 53% for men and 56% for women after adjusting for combat exposure. This combat preference could not be explained by more severe PTSD symptoms or greater functional impairment. CONCLUSIONS: Instead of a gender bias in awards for PTSD service connection, we found evidence of a combat advantage that disproportionately favored men. The appropriateness of this apparent advantage is unclear and needs further investigation.

Reasons registered nurses leave or change employment status.

High turnover of nurses compromises patient care and adds to the cost of healthcare. To determine why nurses changed positions or left a midwestern health system, the authors surveyed registered nurses who voluntarily terminated or changed their employment status to as-needed (PRN) within a 9-month period. They discuss the most frequent reasons given for these changes and suggest solutions for retention.

Effects of women-sensitive, long-term residential treatment on psychological functioning of diverse populations of women.

A number of studies have found that women who abuse substances enter treatment with greater psychological problems and more vulnerabilities than men. This article reports on a 5-year study of clients in a comprehensive, residential drug treatment program for women and their children. Psychological assessments on 362 women included the Basic Personality Inventory (BPI), the Center for Epidemiologic Studies Depression Scale (CES-D), and the Luria-Nebraska Neuropsychological Battery, Screening Test (LNNB-ST). Early in the course of treatment, the typical client tends to experience a great deal of distress, as evidenced by scores on the CES-D. Other assessments indicate she is relatively alienated, mistrustful of others, and resentful of rules imposed on her by others. Repeated assessments show that these psychological indicators improve significantly as the client progresses through the treatment program. Additional studies are needed to focus on long-term treatment outcomes of women in programs designed specifically for them.