Screening and Interventions for Social Risk Factors: Technical Brief to Support the US Preventive Services Task Force.

Importance: Evidence-based guidance is limited on how clinicians should screen for social risk factors and which interventions related to these risk factors improve health outcomes. Objective: To describe research on screening and interventions for social risk factors to inform US Preventive Services Task Force considerations of the implications for its portfolio of recommendations. Data Sources: Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, Ovid MEDLINE, Sociological Abstracts, and Social Services Abstracts (through 2018); Social Interventions Research and Evaluation Network evidence library (January 2019 through May 2021); surveillance through May 21, 2021; interviews with 17 key informants. Study Selection: Individual-level and health care system-level interventions with a link to the health care system that addressed at least 1 of 7 social risk domains: housing instability, food insecurity, transportation difficulties, utility needs, interpersonal safety, education, and financial strain. Data Extraction and Synthesis: One investigator abstracted data from studies and a second investigator evaluated data abstractions for completeness and accuracy; key informant interviews were recorded, transcribed, summarized, and integrated with evidence from the literature; narrative synthesis with supporting tables and figures. Main Outcomes and Measures: Validity of multidomain social risk screening tools; all outcomes reported for social risk-related interventions; challenges or unintended consequences of screening and interventions. Results: Many multidomain social risk screening tools have been developed, but they vary widely in their assessment of social risk and few have been validated. This technical brief identified 106 social risk intervention studies (N = 5 978 596). Of the interventions studied, 73 (69%; n = 127 598) addressed multiple social risk domains. The most frequently addressed domains were food insecurity (67/106 studies [63%], n = 141 797), financial strain (52/106 studies [49%], n = 111 962), and housing instability (63/106 studies [59%], n = 5 881 222). Food insecurity, housing instability, and transportation difficulties were identified by key informants as the most important social risk factors to identify in health care. Thirty-eight studies (36%, n = 5 850 669) used an observational design with no comparator, and 19 studies (18%, n = 15 205) were randomized clinical trials. Health care utilization measures were the most commonly reported outcomes in the 68 studies with a comparator (38 studies [56%], n = 111 102). The literature and key informants described many perceived or potential challenges to implementation of social risk screening and interventions in health care. Conclusions and Relevance: Many interventions to address food insecurity, financial strain, and housing instability have been studied, but more randomized clinical trials that report health outcomes from social risk screening and intervention are needed to guide widespread implementation in health care.

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.

Screening for Obesity and Intervention for Weight Management in Children and Adolescents: Evidence Report and Systematic Review for the US Preventive Services Task Force.

IMPORTANCE: Obesity is common in children and adolescents in the United States, is associated with negative health effects, and increases the likelihood of obesity in adulthood. OBJECTIVE: To systematically review the benefits and harms of screening and treatment for obesity and overweight in children and adolescents to inform the US Preventive Services Task Force. DATA SOURCES: MEDLINE, PubMed, PsycINFO, Cochrane Collaboration Registry of Controlled Trials, and the Education Resources Information Center through January 22, 2016; references of relevant publications; government websites. Surveillance continued through December 5, 2016. STUDY SELECTION: English-language trials of benefits or harms of screening or treatment (behavior-based, orlistat, metformin) for overweight or obesity in children aged 2 through 18 years, conducted in or recruited from health care settings. DATA EXTRACTION AND SYNTHESIS: Two investigators independently reviewed abstracts and full-text articles, then extracted data from fair- and good-quality trials. Random-effects meta-analysis was used to estimate the benefits of lifestyle-based programs and metformin. MAIN OUTCOMES AND MEASURES: Weight or excess weight (eg, body mass index [BMI]; BMI z score, measuring the number of standard deviations from the median BMI for age and sex), cardiometabolic outcomes, quality of life, other health outcomes, harms. RESULTS: There was no direct evidence on the benefits or harms of screening children and adolescents for excess weight. Among 42 trials of lifestyle-based interventions to reduce excess weight (N = 6956), those with an estimated 26 hours or more of contact consistently demonstrated mean reductions in excess weight compared with usual care or other control groups after 6 to 12 months, with no evidence of causing harm. Generally, intervention groups showed absolute reductions in BMI z score of 0.20 or more and maintained their baseline weight within a mean of approximately 5 lb, while control groups showed small increases or no change in BMI z score, typically gaining a mean of 5 to 17 lb. Only 3 of 26 interventions with fewer contact hours showed a benefit in weight reduction. Use of metformin (8 studies, n = 616) and orlistat (3 studies, n = 779) were associated with greater BMI reductions compared with placebo: -0.86 (95% CI, -1.44 to -0.29; 6 studies; I2 = 0%) for metformin and -0.50 to -0.94 for orlistat. Groups receiving lifestyle-based interventions offering 52 or more hours of contact showed greater improvements in blood pressure than control groups: -6.4 mm Hg (95% CI, -8.6 to -4.2; 6 studies; I2 = 51%) for systolic blood pressure and -4.0 mm Hg (95% CI, -5.6 to -2.5; 6 studies; I2 = 17%) for diastolic blood pressure. There were mixed findings for insulin or glucose measures and no benefit for lipids. Medications showed small or no benefit for cardiometabolic outcomes, including fasting glucose level. Nonserious harms were common with medication use, although discontinuation due to adverse effects was usually less than 5%. CONCLUSIONS AND RELEVANCE: Lifestyle-based weight loss interventions with 26 or more hours of intervention contact are likely to help reduce excess weight in children and adolescents. The clinical significance of the small benefit of medication use is unclear.

Risk factors and other epidemiologic considerations for cervical cancer screening: a narrative review for the U.S. Preventive Services Task Force.

Despite the success of cervical cancer screening programs, questions remain about the appropriate time to begin and end screening. This review explores epidemiologic and contextual data on cervical cancer screening to inform decisions about when screening should begin and end. Cervical cancer is rare among women younger than 20 years. Screening for cervical cancer in this age group is complicated by lower rates of detection and higher rates of false-positive results than in older women. Methods used to diagnose and treat cervical intraepithelial neoplasia have important potential adverse effects. High-risk human papillomavirus infections and abnormalities on cytologic and histologic examination have relatively high rates of regression. Accordingly, cervical cancer screening in women younger than 20 years may be harmful. The incidence of, and mortality rates from, cervical cancer and the proportion of U.S. women aged 65 years or older who have had a Papanicolaou smear within 3 years have decreased since 2000. Available evidence supports discontinuation of cervical cancer screening among women aged 65 years or older who have had adequate screening and are not otherwise at high risk. Further reductions in the burden of cervical cancer in older women are probably best achieved by focusing on screening those who have not been adequately screened.

Liquid-based cytology and human papillomavirus testing to screen for cervical cancer: a systematic review for the U.S. Preventive Services Task Force.

BACKGROUND: Screening programs using conventional cytology have successfully reduced cervical cancer, but newer tests might enhance screening. PURPOSE: To systematically review the evidence on liquid-based cytology (LBC) and high-risk human papillomavirus (HPV) screening for U.S. Preventive Services Task Force use in updating its 2003 recommendation. DATA SOURCES: MEDLINE, Cochrane Central Register of Controlled Trials, and PsycINFO from January 2000 through September 2010. STUDY SELECTION: Two independent reviewers selected fair- to good-quality English-language studies that compared LBC or HPV-enhanced primary screening with conventional cytology in countries with developed population-based screening for cervical cancer. DATA EXTRACTION: At least 2 independent reviewers critically appraised and rated the quality of studies and used standardized abstraction forms to extract data about test performance for detecting cervical intraepithelial neoplasia (CIN) and cancer and screening-related harms. DATA SYNTHESIS: On the basis of 4 fair- to good-quality studies (141 566 participants), LBC had equivalent sensitivity and specificity to conventional cytology. Six fair- to good-quality diagnostic accuracy studies showed that 1-time HPV screening was more sensitive than cytology for detecting CIN3+/CIN2+ but was less specific. On the basis of 2 fair- to good-quality randomized, controlled trials (RCTs) (120 533 participants), primary HPV screening detected more cases of CIN3 or cancer in women older than 30 years. Four fair- to good-quality diagnostic accuracy studies and 4 fair- to good-quality RCTs showed mixed results of cotesting (HPV plus cytology) in women aged 30 years or older compared with cytology alone, with no clear advantage over primary HPV screening. Incomplete reporting of results for all screening rounds, including detection of disease and colposcopies, limits our ability to determine the net benefit of HPV-enhanced testing strategies. LIMITATION: Resources were insufficient to gather unpublished data, short-term trial data showed possible ascertainment bias, and most RCTs used protocols that differed from current U.S. practice. CONCLUSION: Evidence supports the use of LBC or conventional cytology for cervical cancer screening, but more complete evidence is needed before HPV-enhanced primary screening is widely adopted for women aged 30 years or older.

Behavioral counseling to prevent skin cancer: a systematic review for the U.S. Preventive Services Task Force.

BACKGROUND: More than 2 million cases of skin cancer are diagnosed annually in the United States, and melanoma incidence is increasing. PURPOSE: To assist the U.S. Preventive Services Task Force in updating its 2003 recommendation on behavioral counseling to prevent skin cancer. DATA SOURCES: Existing systematic reviews, database searches through February 2010, and outside experts. STUDY SELECTION: English-language, primary care-relevant counseling trials to promote sun-protective behaviors and studies examining the association between sun-protective behaviors and skin cancer outcomes or potential adverse effects were included. DATA EXTRACTION: Each study was appraised by using design-specific quality criteria. Important study details were abstracted into evidence tables. DATA SYNTHESIS: 11 fair- or good-quality, randomized, controlled trials examined the counseling interventions' effect on sun-protective behaviors. In young women, appearance-focused behavioral interventions decrease indoor tanning and ultraviolet exposure. In young adolescents, computer support can decrease midday sun exposure and increase sunscreen use. Thirty-five mainly fair-quality observational studies examined the relationship between ultraviolet exposure or sunscreen use and skin cancer. Increasing intermittent sun exposure in childhood is associated with an increased risk for squamous cell carcinoma, basal cell carcinoma, and melanoma. Evidence suggests that regular or early use of indoor tanning may increase melanoma risk. On the basis of 1 fair-quality trial, regular sunscreen use can prevent squamous cell carcinoma, but it is yet unclear if it can prevent basal cell carcinoma or melanoma. LIMITATIONS: There are limited rigorous counseling trials. Observational studies are limited by the complexity of measuring ultraviolet exposure and sunscreen use, and inadequate adjustment for important confounders. CONCLUSION: Randomized, controlled trials suggest that primary care-relevant counseling can increase sun-protective behaviors and decrease indoor tanning.

A feasibility trial of a video intervention to improve informed consent for parents of children with leukemia.

BACKGROUND: Research on parental understanding of informed consent for pediatric randomized clinical trials (RCTs) has highlighted weaknesses in understanding of key aspects of informed consent. The goals of the current study were to assess the feasibility of and parental satisfaction with a video intervention to improve informed consent for pediatric leukemia RCTs and to compare parental question asking during informed consent conferences (ICCs) for parents in the current study with historical control data. PROCEDURE: A 20-min video was produced. Utilizing the principles of anticipatory guidance, it included information delivered by nurses and physicians about leukemia and key aspects of informed consent. Parents were encouraged to be active participants in ICCs. Participants included 12 parents of children newly diagnosed with pediatric leukemia. The video was viewed by local pediatric oncologists prior to utilization with families. RESULTS: Ninety-two percent of parents reported that the video made it easier to understand information that their child's physician later provided; 83% of parents reported that it helped them to think of questions to ask the physician; and 67% of parents indicated that the video made them feel more comfortable with asking questions of the physician. Results of a t-test comparing question asking during ICCs revealed that parents who participated in the intervention asked a higher rate of questions than parents from a historical control sample (t = 1.95, P = 0.05). DISCUSSION: Our study supports the feasibility and potential efficacy of a brief video intervention employing anticipatory guidance to prepare parents for future discussions about RCTs.

Screening for child and adolescent depression in primary care settings: a systematic evidence review for the US Preventive Services Task Force.

CONTEXT: Depression among youth is a disabling condition that is associated with serious long-term morbidities and suicide. OBJECTIVE: To assess the health effects of routine primary care screening for major depressive disorder among children and adolescents aged 7 to 18 years. METHODS: Medline, the Cochrane Central Registry of Controlled Trials, PsycInfo, the Cochrane Database of Systematic Reviews, recent systematic reviews, experts, and bibliographies from selected studies were the data sources. The studies selected were fair- and good-quality (on the basis of US Preventive Services Task Force criteria) controlled trials of screening and treatment (selective serotonin reuptake inhibitor and/or psychotherapy), diagnostic accuracy studies, and large observational studies that reported adverse events. Two reviewers quality-graded each article. One reviewer abstracted relevant information into standardized evidence tables, and a second reviewer checked key elements. RESULTS: We found no data describing health outcomes among screened and unscreened populations. Although the literature on diagnostic screening test accuracy is small and methodologically limited, it indicates that several screening instruments have performed fairly well among adolescents. The literature on treatment efficacy of selective serotonin reuptake inhibitors and/or psychotherapy is also small but includes good-quality randomized, controlled trials. Available data indicate that selective serotonin reuptake inhibitors, psychotherapy, and combined treatment are effective in increasing response rates and reducing depressive symptoms. Not all specific selective serotonin reuptake inhibitors, however, seem to be efficacious. Selective serotonin reuptake inhibitor treatment was associated with a small absolute increase in risk of suicidality (ie, suicidal ideation, preparatory acts, or attempts). No suicide deaths occurred in any of the trials. CONCLUSIONS. Limited available data suggest that primary care-feasible screening tools may accurately identify depressed adolescents and treatment can improve depression outcomes. Treating depressed youth with selective serotonin reuptake inhibitors may be associated with a small increased risk of suicidality and should only be considered if judicious clinical monitoring is possible.

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.

Altruistic discourse in the informed consent process for childhood cancer clinical trials.

Scholars have debated the role that altruistic considerations play--and should play--in recruitment and decision-making processes for clinical trials. Little empirical data are available to support their various perspectives. We analyzed 140 audiotaped pediatric informed consent sessions, of which 95 (68%) included at least one discussion of how participation in a cancer clinical trial might benefit: 1) the pursuit of scientific knowledge generally; 2) other children with cancer specifically; and 3) "the future" and other vaguely defined recipients. Clinicians initiated most (80%) of these discussions of altruism. The enrollment rate of children in the clinical trial was high (83%) overall, but not higher among children whose parents were involved in an altruism-oriented discussion. These findings suggest that: (1) clinicians invoke a spectrum of altruistic considerations rather than a single monothematic notion of altruism, and (2) the effect of altruistic considerations on subsequent enrollment decisions is marginal. While further research on this topic is warranted, bioethical debate should strive to reflect the diversity of altruistic discourse in clinical research encounters and to place this discourse in the context of other, including nonaltruistic, considerations.

Communication of randomization in childhood leukemia trials.

CONTEXT: Most children diagnosed as having leukemia become research subjects in randomized clinical trials (RCTs), but little is known about how randomization is explained to or understood by parents. OBJECTIVE: To investigate physicians' explanation and parental understanding of randomization in childhood leukemia RCTs. DESIGN AND SETTING: A multisite study of the informed consent communication process for RCTs of childhood leukemia. Consecutive cases were recruited from pediatric oncology inpatient wards at 6 US children's hospitals associated with major academic medical centers from July 1, 1999, until December 31, 2001. The informed consent conferences were observed and audiotaped, and the information obtained was coded and analyzed. Parents were interviewed shortly after the conference to ascertain their understanding. PARTICIPANTS: Parents and members of the health care team who participated in 137 informed consent conferences for children with newly diagnosed acute leukemia. MAIN OUTCOME MEASURES: Observed explanations of randomization and parental understanding of randomization after the consent conference. RESULTS: Randomization was explained by physicians in 83% of cases and a consent document was presented during the conference in 95% of cases. Interviews after the conference demonstrated that 68 (50%) of 137 parents did not understand randomization. Parents of racial minority and lower socioeconomic status were less likely to understand randomization (P<.001 for each). Discussion of specific clinical trial details and the presence of a nurse during the conference were associated with understanding. Eighty-four percent of children were enrolled in a leukemia trial. CONCLUSIONS: Despite oral and written explanation, half of the parents in this study did not understand randomization for childhood leukemia trials. To make informed consent more effective, future research must seek to improve communication during this critical interchange.

Groups potentially at risk for making poorly informed decisions about entry into clinical trials for childhood cancer.

PURPOSE: Some patients may be at greater risk than others of enrolling on a randomized clinical trial (RCT) without fully understanding the implications. To investigate this possibility, this study poses the question, Do non-English-speaking Latino parents of children with leukemia show differences in their discussion of and understanding of an RCT when compared with English-speaking minority parents and with English-speaking majority (ie, white) parents? This research hypothesizes that factors such as social and educational status and the role of language interpreters may account for significant differences in the discussion and understanding of an RCT among the three groups. PATIENTS AND METHODS: A total of 108 parents are reported on, all of whom were observed, interviewed, and audiotaped during informed-consent discussions about participation in an RCT with their child's oncologist. Comparisons among the groups were performed using chi2 tests and a one-way analysis of variance. RESULTS: Problems of consent-related communication and understanding were more frequent among parents of low social status who spoke little or no English than they were in the two other groups. Several factors may have contributed to this disparity, including language interpretation, social status, and prevailing cultural norms. CONCLUSION: Some patients may be at greater risk than others of enrolling on an RCT without fully understanding the implications of their decision to do so. Numerous factors may contribute to this disparity, including language interpretation, social status, and prevailing cultural norms. Some specific strategies are suggested to help address this disparity.

Assent observed: children's involvement in leukemia treatment and research discussions.

OBJECTIVE: Assent is a critical issue in pediatric ethics that has not been well-studied. We examined the role of older children in discussing a recent diagnosis of acute leukemia and treatment options, including participation in a randomized, clinical trial (RCT). DESIGN: Our sample was drawn from data collected as part of a larger, National Cancer Institute-funded study in which we observed, tape-recorded, and transcribed the informed consent conference (ICC) for children with leukemia at 6 institutions. We analyzed the data for the child's presence and role, examined 5 discussion categories relevant to assent in the context of pediatric cancer treatment/research, conducted parent interviews, and administered clinician questionnaires to examine these issues. We report a qualitative analysis of 14 cases in which the child was present for the ICC. RESULTS: Clinicians varied with regard to whom they directed specific discussions when patients were present. Questions asked by the children predominantly related to details of the disease and treatment, with few questions about the RCT. Clinicians and parents attribute responsibility for decision-making about participation in RCTs in a variety of ways. In conferences that included the child-patient, parents asked significantly fewer questions than in other ICCs. CONCLUSION: There is significant variation among ICCs that include the older child. Additional empirical study of assent is warranted, and our data suggest several hypotheses that should be tested in future research.