Michelle Eder

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.

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.

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.

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.

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

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.

An approach to addressing subpopulation considerations in systematic reviews: the experience of reviewers supporting the U.S. Preventive Services Task Force

BackgroundGuideline developers and other users of systematic reviews need information about whether a medical or preventive intervention is likely to benefit or harm some patients more (or less) than the average in order to make clinical practice recommendations tailored to these populations. However, guidance is lacking on how to include patient subpopulation considerations into the systematic reviews upon which guidelines are often based. In this article, we describe methods developed to consistently consider the evidence for relevant subpopulations in systematic reviews conducted to support primary care clinical preventive service recommendations made by the U.S. Preventive Services Task Force (USPSTF).Proposed approachOur approach is grounded in our experience conducting systematic reviews for the USPSTF and informed by a review of existing guidance on subgroup analysis and subpopulation issues. We developed and refined our approach based on feedback from the Subpopulation Workgroup of the USPSTF and pilot testing on reviews being conducted for the USPSTF. This paper provides processes and tools for incorporating evidence-based identification of important sources of potential heterogeneity of intervention effects into all phases of systematic reviews. Key components of our proposed approach include targeted literature searches and key informant interviews to identify the most important subpopulations a priori during topic scoping, a framework for assessing the credibility of subgroup analyses reported in studies, and structured investigation of sources of heterogeneity of intervention effects.ConclusionsFurther testing and evaluation are necessary to refine this proposed approach and demonstrate its utility to the producers and users of systematic reviews beyond the context of the USPSTF. Gaps in the evidence on important subpopulations identified by routinely applying this process in systematic reviews will also inform future research needs.

The nurse as witness in the research consent/assent process: An inherently problematic role, or an ethical obligation?☆

From the Division of Patient Care Services, St. Jude Children ’s Research Hospital, Memphis, TN; and the Rainbow Center for Pediatric Ethics and Children’s Hospital, Cleveland, OH. The work of Ms. Eder and Dr. Kodzsh has been supported by grants from the Rainbow Board of Trustees, the Greenwall Foundation, and NIH RO 1 CA83267. Address reprint requests to Pamela S. Hinds, PhD, RN, CS, Director of Nursing Research, Division of Patzent Care Services, St. Jude Children’s Research Hospital, 332 N. Lauderdale, Memphis, TN 38105 (e-mail: pam.hinds@stjude.org); or to Erzc Kodzsh, MD, Rainbow Babies’and Children Hospital, 11100 Euclid Ave, RBC 310, Cleveland, OH 44106 (e-mazl: edk4@po.cwru.edu).

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 Forces use of rapid review methodology, its criteria for selecting topics for rapid evidence syntheses, and proposed methods to streamline the review process.