Evaluating Intensity, Complexity, and Potential for Causal Inference in Social Needs Interventions: A Review of a Scoping Review.

Importance: Interventions that address needs such as low income, housing instability, and safety are increasingly appearing in the health care sector as part of multifaceted efforts to improve health and health equity, but evidence relevant to scaling these social needs interventions is limited. Objective: To summarize the intensity and complexity of social needs interventions included in randomized clinical trials (RCTs) and assess whether these RCTs were designed to measure the causal effects of intervention components on behavioral, health, or health care utilization outcomes. Evidence Review: This review of a scoping review was based on a Patient-Centered Outcomes Research Institute-funded evidence map of English-language US-based RCTs of social needs interventions published between January 1, 1995, and April 6, 2023. Studies were assessed for features related to intensity (defined using modal values as providing as-needed interaction, 8 participant contacts or more, contacts occurring every 2 weeks or more often, encounters of 30 minutes or longer, contacts over 6 months or longer, or home visits), complexity (defined as addressing multiple social needs, having dedicated staff, involving multiple intervention components or practitioners, aiming to change multiple participant behaviors [knowledge, action, or practice], requiring or providing resources or active assistance with resources, and permitting tailoring), and the ability to assess causal inferences of components (assessing interventions, comparators, and context). Findings: This review of a scoping review of social needs interventions identified 77 RCTs in 93 publications with a total of 135 690 participants. Most articles (68 RCTs [88%]) reported 1 or more features of high intensity. All studies reported 1 or more features indicative of high complexity. Because most studies compared usual care with multicomponent interventions that were moderately or highly dependent on context and individual factors, their designs permitted causal inferences about overall effectiveness but not about individual components. Conclusions and Relevance: Social needs interventions are complex, intense, and include multiple components. Our findings suggest that RCTs of these interventions address overall intervention effectiveness but are rarely designed to distinguish the causal effects of specific components despite being resource intensive. Future studies with hybrid effectiveness-implementation and sequential designs, and more standardized reporting of intervention intensity and complexity could help stakeholders assess the return on investment of these interventions.

Screening for Syphilis Infection in Pregnant Women: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force.

Importance: The incidence of syphilis and congenital syphilis in the United States has increased after reaching historic lows in the early 2000s. Objective: To systematically review literature on the effectiveness and harms of screening for syphilis in pregnancy and the harms of penicillin treatment in pregnancy to inform the US Preventive Services Task Force. Data Sources: MEDLINE, PubMed, and the Cochrane Central Register of Controlled Trials for relevant English-language literature, published from January 1, 2008, to June 2, 2017. Ongoing surveillance was conducted through November 22, 2017. Study Selection: Studies conducted in countries categorized as "high" or "very high" on the Human Development Index that explicitly addressed 1 of 3 a priori-defined key questions. Data Extraction and Synthesis: Independent critical appraisal and data abstraction by 2 reviewers. Data from included studies were narratively synthesized without pooling data. Main Outcomes and Measures: Incidence of congenital syphilis; any harms of screening or penicillin treatment in pregnancy. Results: Seven studies in 8 publications were included. One observational study evaluated the implementation of syphilis screening in pregnancy in 2 441 237 women in China. From 2002 to 2012, screening for syphilis in all pregnant women increased from 89.8% to 97.2%, and the incidence of congenital syphilis decreased from 109.3 to 9.4 cases per 100 000 live births. Five studies (n = 21 795) evaluated the false-positive findings of treponemal tests and 1 study (n = 318) evaluated the false-negative findings of nontreponemal tests. These studies found that false-positives with treponemal-specific enzyme or chemiluminescent immunoassays were common (46.5%-88.2%), therefore warranting reflexive (automatic confirmatory) testing for all positive test findings. One study (n = 318) found no false-negatives with treponemal tests, and 1 study (n = 139) demonstrated the prozone phenomenon (false-negative response from high antibody titer) with rapid plasma reagin screening using undiluted samples (2.9%). No studies were identified for harms of penicillin in pregnancy. Conclusions and Relevance: Screening for syphilis infection in pregnant women is associated with reduced incidence of congenital syphilis, and available evidence supports the need for reflexive testing for positive test results.

The Use of Rapid Review Methods for the U.S. Preventive Services Task Force.

Rapid review products are intended to synthesize available evidence in a timely fashion while still meeting the needs of healthcare decision makers. Various methods and products have been applied for rapid evidence syntheses, but no single approach has been uniformly adopted. Methods to gain efficiency and compress the review time period include focusing on a narrow clinical topic and key questions; limiting the literature search; performing single (versus dual) screening of abstracts and full-text articles for relevance; and limiting the analysis and synthesis. In order to maintain the scientific integrity, including transparency, of rapid evidence syntheses, it is imperative that procedures used to streamline standard systematic review methods are prespecified, based on sound review principles and empiric evidence when possible, and provide the end user with an accurate and comprehensive synthesis. The collection of clinical preventive service recommendations maintained by the U.S. Preventive Services Task Force, along with its commitment to rigorous methods development, provide a unique opportunity to refine, implement, and evaluate rapid evidence synthesis methods and add to an emerging evidence base on rapid review methods. This paper summarizes the U.S. Preventive Services Task Force's use of rapid review methodology, its criteria for selecting topics for rapid evidence syntheses, and proposed methods to streamline the review process.

Improving informed consent: suggestions from parents of children with leukemia.

OBJECTIVE: The objective of this study was to report suggestions for improving the informed consent process from the perspective of parents of children with leukemia. METHODS: Recommendations for improving informed consent were elicited from 140 parents of children who had been offered participation in a randomized clinical trial for the treatment of their acute leukemia. Four different methods and data collection time points were used with this group of parents, including open-ended, in-person interviews within 72 hours after the informed consent conference; follow-up telephone interviews 6 months after diagnosis; focus groups during year 3 of the project; and a parent advisory group on informed consent meeting in year 4. RESULTS: The most frequently cited suggestions for improving informed consent during the interviews and focus groups related to giving parents more time to make their decision, the amount and type of information provided, organization of the consent conference, communication style, and providing additional materials. During the parent advisory group on informed consent meeting, parents developed specific guidelines for organization of the information that is presented during the consent process that include 7 major components: timing, sequence, checklist, checking for understanding, anticipatory guidance, segue into randomized clinical trial discussion with historical perspective, and choice. CONCLUSIONS: Through the incorporation of parental perspectives that provide an authentic stakeholder voice, our research represents a true partnership approach to improving the consent process. Parents provided practical advice for improving informed consent that can be applied to most adult and pediatric patient populations.