Survival outcomes used to generate version 9 American Joint Committee on Cancer staging system for anal cancer.

The American Joint Committee on Cancer (AJCC) staging system for all cancer sites, including anal cancer, is the standard for cancer staging in the United States. The AJCC staging criteria are dynamic, and periodic updates are conducted to optimize AJCC staging definitions through a panel of experts charged with evaluating new evidence to implement changes. With greater availability of large data sets, the AJCC has since restructured and updated its processes, incorporating prospectively collected data to validate stage group revisions in the version 9 AJCC staging system, including anal cancer. Survival analysis using AJCC eighth edition staging guidelines revealed a lack of hierarchical order in which stage IIIA anal cancer was associated with a better prognosis than stage IIB disease, suggesting that, for anal cancer, tumor (T) category has a greater effect on survival than lymph node (N) category. Accordingly, version 9 stage groups have been appropriately adjusted to reflect contemporary long-term outcomes. This article highlights the changes to the now published AJCC staging system for anal cancer, which: (1) redefined stage IIB as T1-T2N1M0 disease, (2) redefined stage IIIA as T3N0-N1M0 disease, and (3) eliminated stage 0 disease from its guidelines altogether.

Survival outcomes used to validate version 9 of the American Joint Committee on Cancer staging system for appendiceal cancer.

The standard for cancer staging in the United States for all cancer sites, including primary carcinomas of the appendix, is the American Joint Committee on Cancer (AJCC) staging system. AJCC staging criteria undergo periodic revisions, led by a panel of site-specific experts, to maintain contemporary staging definitions through the evaluation of new evidence. Since its last revision, the AJCC has restructured its processes to include prospectively collected data because large data sets have become increasingly robust and available over time. Thus survival analyses using AJCC eighth edition staging criteria were used to inform stage group revisions in the version 9 AJCC staging system, including appendiceal cancer. Although the current AJCC staging definitions were maintained for appendiceal cancer, incorporating survival analysis into the version 9 staging system provided unique insight into the clinical challenges in staging rare malignancies. This article highlights the critical clinical components of the now published version 9 AJCC staging system for appendix cancer, which (1) justified the separation of three different histologies (non-mucinous, mucinous, signet-ring cell) in terms of prognostic variance, (2) demonstrated the clinical implications and challenges in staging heterogeneous and rare tumors, and (3) emphasized the influence of data limitations on survival analysis for low-grade appendiceal mucinous neoplasms.

Data-driven optimization of version 9 American Joint Committee on Cancer staging system for anal cancer.

INTRODUCTION: The American Joint Committee on Cancer (AJCC) staging system undergoes periodic revisions to maintain contemporary survival outcomes related to stage. Recently, the AJCC has developed a novel, systematic approach incorporating survival data to refine stage groupings. The objective of this study was to demonstrate data-driven optimization of the version 9 AJCC staging system for anal cancer assessed through a defined validation approach. METHODS: The National Cancer Database was queried for patients diagnosed with anal cancer in 2012 through 2017. Kaplan-Meier methods analyzed 5-year survival by individual clinical T category, N category, M category, and overall stage. Cox proportional hazards models validated overall survival of the revised TNM stage groupings. RESULTS: Overall, 24,328 cases of anal cancer were included. Evaluation of the 8th edition AJCC stage groups demonstrated a lack of hierarchical prognostic order. Survival at 5 years for stage I was 84.4%, 77.4% for stage IIA, and 63.7% for stage IIB; however, stage IIIA disease demonstrated a 73.0% survival, followed by 58.4% for stage IIIB, 59.9% for stage IIIC, and 22.5% for stage IV (p <.001). Thus, stage IIB was redefined as T1-2N1M0, whereas Stage IIIA was redefined as T3N0-1M0. Reevaluation of 5-year survival based on data-informed stage groupings now demonstrates hierarchical prognostic order and validated via Cox proportional hazards models. CONCLUSION: The 8th edition AJCC survival data demonstrated a lack of hierarchical prognostic order and informed revised stage groupings in the version 9 AJCC staging system for anal cancer. Thus, a validated data-driven optimization approach can be implemented for staging revisions across all disease sites moving forward.

Renovating the Commission on Cancer's Quality Measure Portfolio.

IMPORTANCE: Nearly 75% of newly diagnosed cancer patients in the United States will receive care from a hospital that is accredited by the Commission on Cancer (CoC). To support hospitals in their quality assurance efforts, the CoC maintains a portfolio of quality measures to give hospitals compliance data with select best practices for cancer care. As the CoC quality measures have evolved over recent years, many clinicians may lack awareness of the intent and content of the measure portfolio, as well as the mechanism by which new measures originate. OBSERVATIONS: The CoC quality measures are based on data that hospitals submit to the National Cancer Database, allowing the CoC to track compliance with a subset of consensus best practices. Each year, new measures are designed by diverse teams of specialists in the different treatment modalities for the tumor types covered by the portfolio. These proposed measures are then subjected to a range of vetting, refinement, and prioritization steps before being voted into the portfolio by the Quality Assurance and Data Committee of the CoC. Over the past 4 years, the CoC has worked to renovate not only the portfolio but also the process used to create and launch new measures, revise existing measures, and retire obsolete measures. CONCLUSION AND RELEVANCE: In the following overview, we outline the current measure process, highlight important changes to the portfolio, and share opportunities to further increase the impact.

The National Cancer Database Conforms to the Standardized Framework for Registry and Data Quality.

BACKGROUND: Standardization of procedures for data abstraction by cancer registries is fundamental for cancer surveillance, clinical and policy decision-making, hospital benchmarking, and research efforts. The objective of the current study was to evaluate adherence to the four components (completeness, comparability, timeliness, and validity) defined by Bray and Parkin that determine registries' ability to carry out these activities to the hospital-based National Cancer Database (NCDB). METHODS: Tbis study used data from U.S. Cancer Statistics, the official federal cancer statistics and joint effort between the Centers for Disease Control and Prevention (CDC) and the National Cancer Institute (NCI), which includes data from National Program of Cancer Registries (NPCR) and Surveillance, Epidemiology, and End Results (SEER) to evaluate NCDB completeness between 2016 and 2020. The study evaluated comparability of case identification and coding procedures. It used Commission on Cancer (CoC) standards from 2022 to assess timeliness and validity. RESULTS: Completeness was demonstrated with a total of 6,828,507 cases identified within the NCDB, representing 73.7% of all cancer cases nationwide. Comparability was followed using standardized and international guidelines on coding and classification procedures. For timeliness, hospital compliance with timely data submission was 92.7%. Validity criteria for re-abstracting, recording, and reliability procedures across hospitals demonstrated 94.2% compliance. Additionally, data validity was shown by a 99.1% compliance with histologic verification standards, a 93.6% assessment of pathologic synoptic reporting, and a 99.1% internal consistency of staff credentials. CONCLUSION: The NCDB is characterized by a high level of case completeness and comparability with uniform standards for data collection, and by hospitals with high compliance, timely data submission, and high rates of compliance with validity standards for registry and data quality evaluation.

Evaluation of the Impact of the COVID-19 Pandemic on Reliability of Cancer Surveillance Data in the National Cancer Database.

PURPOSE: This study evaluated the reliability of cancer cases reported to the National Cancer Database (NCDB) during 2020, the first year of the COVID-19 pandemic. METHODS: Total number of cancer cases reported to the NCDB between January 2018 and December 2020 were calculated for all cancers and 21 selected cancer sites. The additive outlier method was used to identify structural breaks in trends compared with previous years. The difference between expected (estimated using the vector autoregressive method) and observed number of cases diagnosed in 2020 was estimated using generalized estimating equation under assumptions of the Poisson distribution for count data. Interrupted time series analysis was used to compare changes in the number of records processed by registrars each month of 2020. All models accounted for seasonality, regional variation, and random error. RESULTS: There was a statistically significant decrease (structural break) in the number of cases diagnosed in April 2020, with no recovery in number of cases during subsequent months, leading to a 12.4% deficit in the number of cases diagnosed during the first year of the pandemic. While the number of cancer records initiated by cancer registrars also decreased, the number of records marked completed increased during the first months of the pandemic. CONCLUSION: There was a significant deficit in the number of cancer diagnoses in 2020 that was not due to cancer registrars' inability to extract data during the pandemic. Future studies can use NCDB data to evaluate the impact of the pandemic on cancer care and outcomes.

Telehealth for Women's Preventive Services for Reproductive Health and Intimate Partner Violence: a Comparative Effectiveness Review.

BACKGROUND: Telehealth delivery of preventive health services may improve access to care; however, its effectiveness and adverse effects are unknown. We conducted a comparative effectiveness review on the effectiveness and harms of telehealth interventions for women's reproductive health and intimate partner violence (IPV) services. METHODS: We searched MEDLINE, Cochrane Library, CINAHL, and Scopus for English-language studies (July 2016 to May 2022) for randomized controlled trials (RCTs) and observational studies of telehealth strategies for women's reproductive health and IPV versus usual care. Two investigators identified studies and abstracted data using a predefined protocol. Study quality was assessed using study design-specific standardized methods; disagreements were resolved through consensus. RESULTS: Eight RCTs, 1 nonrandomized trial, and 7 observational studies (n=10 731) were included (7 studies of contraceptive care and 9 of IPV services). Telehealth interventions to supplement contraceptive care demonstrated similar rates as usual care for contraceptive use, sexually transmitted infections, and pregnancy (low strength of evidence [SOE]); evidence on abortion was insufficient. Outcomes were also similar between telehealth interventions to replace or supplement IPV services and comparators for repeat IPV, depression, posttraumatic stress disorder, fear of partner, coercive control, self-efficacy, and safety behaviors (low SOE). In these studies, telehealth barriers included limited internet access, digital literacy, technical challenges, and confidentiality concerns. Strategies to ensure safety increased telehealth use for IPV services. Evidence on access, health equity, or harms was lacking. DISCUSSION: Telehealth interventions for contraceptive care and IPV services demonstrate equivalent clinical and patient-reported outcomes versus in-person care, although few studies are available. Effective approaches for delivering these services and how to best mobilize telehealth, particularly for women facing barriers to care remain uncertain. TRIAL REGISTRATION: PROSPERO CRD42021282298.

Preventing Obesity in Midlife Women: A Systematic Review for the Women's Preventive Services Initiative.

BACKGROUND: Despite high prevalence rates of obesity in the United States, no clinical guidelines exist for obesity prevention in midlife women who commonly experience weight gain. PURPOSE: To evaluate evidence on the effectiveness and harms of behavioral interventions to reduce weight gain and improve health outcomes for women aged 40 to 60 years without obesity. DATA SOURCES: English-language searches of Ovid MEDLINE, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews (inception to 26 October 2021); ClinicalTrials.gov (October 2021); and reference lists of studies and reviews. STUDY SELECTION: Randomized controlled trials (RCTs) enrolling predominantly midlife women comparing behavioral interventions to prevent weight gain with control groups and reporting health outcomes and potential harms. DATA EXTRACTION: Dual extraction and quality assessment of individual studies. DATA SYNTHESIS: Seven RCTs in 12 publications (n = 51 638) were included. Four RCTs showed statistically significant favorable differences in weight change for counseling interventions versus control groups (mean difference of weight change, -0.87 to -2.5 kg), whereas 1 trial of counseling and 2 trials of exercise showed no differences; 1 of 2 RCTs reported improved quality-of-life measures. Interventions did not increase measures of depression or stress in 1 trial; self-reported falls (37% vs. 29%; P < 0.001) and injuries (19% vs. 14%; P = 0.03) were higher with exercise counseling in 1 trial. LIMITATION: Trials were generally small, heterogeneous, and lacked data on harms, long-term health outcomes, and specific patient populations. CONCLUSION: Counseling interventions to prevent weight gain in women during midlife may result in modest differences in weight change without causing important harms. More research is needed to determine optimal content, frequency, length, and number of sessions required and should include additional patient populations. PRIMARY FUNDING SOURCE: Health Resources and Services Administration.

Effectiveness and Harms of Contraceptive Counseling and Provision Interventions for Women : A Systematic Review and Meta-analysis.

BACKGROUND: The effectiveness and harms of contraceptive counseling and provision interventions are unclear. PURPOSE: To evaluate evidence of the effectiveness of contraceptive counseling and provision interventions for women to increase use of contraceptives and reduce unintended pregnancy, as well as evidence of their potential harms. DATA SOURCES: English-language searches of Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, PsycINFO, SocINDEX, and MEDLINE (1 January 2000 to 3 February 2022) and reference lists of key studies and systematic reviews. STUDY SELECTION: Randomized controlled trials of interventions providing enhanced contraceptive counseling, contraceptives, or both versus usual care or an active control. DATA EXTRACTION: Dual extraction and quality assessment of studies; results combined using a profile likelihood random-effects model. DATA SYNTHESIS: A total of 38 trials (43 articles [25 472 participants]) met inclusion criteria. Contraceptive use was higher with various counseling interventions (risk ratio [RR], 1.39 [95% CI, 1.16 to 1.72]; I 2 = 85.3%; 10 trials), provision of emergency contraception in advance of use (RR, 2.12 [CI, 1.79 to 2.36]; I 2 = 0.0%; 8 trials), and counseling or provision postpartum (RR, 1.15 [CI, 1.01 to 1.52]; I 2 = 6.6%; 5 trials) or at the time of abortion (RR, 1.19 [CI, 1.09 to 1.32]; I 2 = 0.0%; 5 trials) than with usual care or active controls in multiple clinical settings. Pregnancy rates were generally lower with interventions, although most trials were underpowered and did not distinguish pregnancy intention. Interventions did not increase risk for sexually transmitted infections (STIs) (RR, 1.05 [CI, 0.87 to 1.25]; I 2 = 0.0%; 5 trials) or reduce condom use (RR, 1.03 [CI, 0.94 to 1.13]; I 2 = 0.0%; 6 trials). LIMITATION: Interventions varied; few trials were adequately designed to determine unintended pregnancy outcomes. CONCLUSION: Contraceptive counseling and provision interventions that provide services beyond usual care increase contraceptive use without increasing STIs or reducing condom use. Contraceptive care in clinical practice could be improved by implementing enhanced contraceptive counseling, provision, and follow-up; providing emergency contraception in advance; and delivering contraceptive services immediately postpartum or at the time of abortion. PRIMARY FUNDING SOURCE: Resources Legacy Fund. (PROSPERO: CRD42020192981).

Preventing Obesity in Midlife Women: A Recommendation From the Women's Preventive Services Initiative.

DESCRIPTION: The Women's Preventive Services Initiative (WPSI), a national coalition of women's health professional organizations and patient advocacy representatives, developed a recommendation for counseling midlife women aged 40 to 60 years with normal or overweight body mass index (BMI; 18.5 to 29.9 kg/m2) to maintain weight or limit weight gain to prevent obesity with the long-term goals of optimizing health, function, and well-being. This recommendation is intended to guide clinical practice and coverage of clinical preventive health services for the Health Resources and Services Administration and other stakeholders. Clinicians providing preventive health care to women in primary care settings are the target audience for this recommendation. METHODS: The WPSI developed this recommendation after evaluating results of a systematic review of the effectiveness and harms of interventions to prevent weight gain and obesity in women aged 40 to 60 years without obesity. Seven randomized clinical trials including 51 638 participants and using various counseling and behavioral interventions were included. Trials indicated favorable weight changes with interventions that were statistically significantly different from control groups in 4 of 5 trials of counseling, but not in 2 trials of exercise. Few harms were reported. RECOMMENDATION: The WPSI recommends counseling midlife women aged 40 to 60 years with normal or overweight BMI (18.5 to 29.9 kg/m2) to maintain weight or limit weight gain to prevent obesity. Counseling may include individualized discussion of healthy eating and physical activity.

A national quality improvement study identifying and addressing cancer screening deficits due to the COVID-19 pandemic.

BACKGROUND: Cancer-related deaths over the next decade are expected to increase due to cancer screening deficits associated with the coronavirus disease 2019 (COVID-19) pandemic. Although national deficits have been quantified, a structured response to identifying and addressing local deficits has not been widely available. The objectives of this report are to share preliminary data on monthly screening deficits in breast, colorectal, lung, and cervical cancers across diverse settings and to provide online materials from a national quality improvement (QI) study to help other institutions to address local screening deficits. METHODS: This prospective, national QI study on Return-to-Screening enrolled 748 accredited cancer programs in the United States from April through June 2021. Local prepandemic and pandemic monthly screening test volumes (MTVs) were used to calculate the relative percent change in MTV to describe the monthly screening gap. RESULTS: The majority of facilities reported monthly screening deficits (colorectal cancer, 80.6% [n = 104/129]; cervical cancer, 69.0% [n = 20/29]; breast cancer, 55.3% [n = 241/436]; lung cancer, 44.6% [n = 98/220]). Overall, the median relative percent change in MTV ranged from -17.7% for colorectal cancer (interquartile range [IQR], -33.6% to -2.8%), -6.8% for cervical cancer (IQR, -29.4% to 1.7%), -1.6% for breast cancer (IQR, -9.6% to 7.0%), and 1.2% for lung cancer (IQR, -16.9% to 19.0%). Geographic differences were not observed. There were statistically significant differences in the percent change in MTV between institution types for colorectal cancer screening (P = .02). CONCLUSION: Cancer screening is still in need of urgent attention, and the screening resources made available online may help facilities to close critical gaps and address screenings missed in 2020. LAY SUMMARY: Question: How can the effects of the coronavirus disease 2019 pandemic on cancer screening be mitigated? FINDINGS: When national resources were provided, including methods to calculate local screening deficits, 748 cancer programs promptly enrolled in a national Return-to-Screening study, and the majority identified local screening deficits, most notably in colorectal cancer. Using these results, 814 quality improvement projects were initiated with the potential to add 70,000 screening tests in 2021. Meaning: Cancer screening is still in need of urgent attention, and the online resources that we provide may help to close critical screening deficits.

Twenty-Five Years of Cancer Follow-Up; Is the Data Worth the Effort?

BACKGROUND: Substantial resources are dedicated to long-term follow-up within cancer registries; however, the completeness of these data is poorly characterized. Our objectives were to quantify long-term cancer follow-up data completeness and the effort required to collect these data using the National Cancer Database (NCDB). METHODS: To quantify data completeness, patients diagnosed with cancer in 1989 were identified in the NCDB and loss to follow-up rates were assessed for 25 years after diagnosis. To quantify data collection effort, patients diagnosed from 1989 to 2014 who were alive and eligible for follow-up in 2014 were identified and the effort to perform patient follow-up was obtained via a survey of tumor registrars. The effort to perform follow-up beyond various intervals after diagnosis was calculated. RESULTS: In total, 484,201 patients at 958 hospitals were diagnosed with cancer in 1989. After 5 years, 6.5% of patients were lost to follow-up (13.1% of living patients), 50.3% were deceased, and 43.2% had ongoing follow-up. After 15 years, 22.9% were lost to follow-up (68.7% of living patients), 66.7% were deceased, and 10.5% had ongoing follow-up. By 25 years, loss to follow-up increased to 28.6% (93.7% of living patients), 69.5% were deceased, and 1.9% had ongoing follow-up. In 2014, 522,838 h were spent performing follow-up for 2,091,353 patients at 1456 hospitals who were >15 years from their initial cancer diagnosis. CONCLUSIONS: While 5-year follow-up is excellent in the NCDB, loss to follow-up increases over time. The impact of curtailing data collection is under investigation and follow-up duration requirements will be re-evaluated.

Evaluating information loss in the National Cancer Database from cases lost to follow-up.

BACKGROUND AND OBJECTIVES: Cancer registries must focus on data capture which returns value while reducing resource burden with minimal loss of data. Identifying the optimum length of follow-up data collection for patients with cancer achieves this goal. METHODS: A two-step analysis using entropy calculations to assess information gain for each follow-up year, and second-order differences to compare survival outcomes between the defined follow-up periods and lifetime follow-up. A total of 391 567 adult cases, deidentified in the National Cancer Database and diagnosed in 1989. Comparisons examined a subset of 61 908 lung cancer cases, 48 387 colon and rectal cancer cases, and 64 134 breast cancer cases in adults. A total of 4133 pediatric cases were diagnosed in 1989 examining 1065 leukemia cases and 494 lymphoma cases. RESULTS: Annual increases in information gain fell below 1% after 16 years of follow-up for adult cases and 9 years for pediatric cases. Comparison of second-order differences showed 62% of the comparisons were similar between 15 years and lifetime follow-up when examining restricted mean survival time. In addition, 90% of the comparisons were statistically similar when comparing hazard ratios. CONCLUSIONS: Survival analysis using 15 years postdiagnosis follow-up showed minimal differences in information gain compared to lifetime follow-up.

Associations of Unintended Pregnancy With Maternal and Infant Health Outcomes: A Systematic Review and Meta-analysis.

Importance: Unintended pregnancy is common in the US and is associated with adverse maternal and infant health outcomes; however, estimates of these associations specific to current US populations are lacking. Objective: To evaluate associations of unintended pregnancy with maternal and infant health outcomes during pregnancy and post partum with studies relevant to current clinical practice and public health in the US. Data Sources: Cochrane Central Register of Controlled Trials and Database of Systematic Reviews, PsycINFO, SocINDEX, and MEDLINE databases (January 1, 2000, to June 15, 2022) and manual review of reference lists. Study Selection: Epidemiologic studies relevant to US populations that compared key maternal and infant health outcomes for unintended vs intended pregnancies and met prespecified eligibility criteria were included after investigators' independent dual review of abstracts and full-text articles. Data Extraction and Synthesis: Investigators abstracted data from publications on study methods, participant characteristics, settings, pregnancy intention, comparators, confounders, and outcomes; data were validated by a second investigator. Risk of bias was independently dual rated by investigators using criteria developed by the US Preventive Services Task Force. Results of studies controlling for confounders were combined by using a profile likelihood random-effects model. Main Outcomes and Measures: Prenatal depression, postpartum depression, maternal experience of interpersonal violence, preterm birth, and infant low birth weight. Results: Thirty-six studies (N = 524 522 participants) were included (14 cohort studies rated good or fair quality; 22 cross-sectional studies); 12 studies used large population-based data sources. Compared with intended pregnancy, unintended pregnancy was significantly associated with higher odds of depression during pregnancy (23.3% vs 13.9%; adjusted odds ratio [aOR], 1.59 [95% CI, 1.35-1.92]; I2 = 85.0%; 15 studies [n = 41 054]) and post partum (15.7% vs 9.6%; aOR, 1.51 [95% CI, 1.40-1.70]; I2 = 7.1%; 10 studies [n = 82 673]), interpersonal violence (14.6% vs 5.5%; aOR, 2.22 [95% CI, 1.41-2.91]; I2 = 64.1%; 5 studies [n = 42 306]), preterm birth (9.4% vs 7.7%; aOR, 1.21 [95% CI, 1.12-1.31]; I2 = 1.7%; 10 studies [n = 94 351]), and infant low birth weight (7.3% vs 5.2%; aOR, 1.09 [95% CI, 1.02-1.21]; I2 = 0.0%; 8 studies [n = 87 547]). Results were similar in sensitivity analyses based on controlling for history of depression for prenatal and postpartum depression and on study design and definition of unintended pregnancy for relevant outcomes. Studies provided limited sociodemographic data and measurement of confounders and outcomes varied. Conclusions and Relevance: In this systematic review and meta-analysis of epidemiologic observational studies relevant to US populations, unintended pregnancy, compared with intended pregnancy, was significantly associated with adverse maternal and infant outcomes. Trial Registration: PROSPERO Identifier: CRD42020192981.

Uptake of Breast Cancer Clinical Trials at Minority Serving Cancer Centers.

BACKGROUND: Most minorities receive cancer care at minority-serving hospitals (MSHs) that have been associated with disparate treatment between Black and White patients. OBJECTIVE: Our aim was to examine the uptake of clinical trials that have changed axillary management in breast cancer patients at MSH and non-MSH cancer centers. METHODS: The National Cancer Database was used to identify patients eligible for the American College of Surgeons Oncology Group Z0011 and Z1071 trials, and mastectomy patients fulfilling the European AMAROS trial. Uptake of trial results (omission of axillary lymph node dissection) was analyzed between patients treated at MSHs and non-MSHs and adjusted for patient, tumor, and facility factors. MSHs were defined as the top decile of hospitals according to the proportion of Black and Hispanic patients treated. RESULTS: Of 7167 patients eligible for Z0011, 4546 for Z0171, and 9433 for AMAROS from 2015 to 2016, clinical trial uptake was seen in 1195 (74.6%) MSH and 4056 (72.9%) non-MSH patients (p = 0.173) for Z0011, 588 (41.9%) MSH and 1366 (43.5%) non-MSH patients for Z1071 (p = 0.302), and 272 (11.7%) MSH and 996 (14.0%) non-MSH patients (p = 0.005) for AMAROS. On adjusted analyses, MSH status was not significant for uptake of any of the three trials. Black race, socioeconomic status, and insurance were not associated with clinical trial uptake. CONCLUSION: The uptake of three landmark clinical trials of axillary management in breast cancer was not different at MSH and non-MSH centers despite adjustment for social determinants of health. At the Commission on Cancer-accredited centers in this analysis, MSH status did not affect the uptake of evidence-based care.

The intersection of tumor location and combined bowel preparation: Utilization differs but anastomotic leak risk reduction does not.

BACKGROUND AND OBJECTIVE: Whether bowel preparation utilization rates or effectiveness varies based on tumor location is unknown. METHODS: The 2012-2016 American College of Surgeons National Surgical Quality Improvement Program Colectomy Targeted participant user file was queried for patients undergoing elective colorectal resection for cancer. Bowel preparation was classified as combined, mechanical bowel preparation alone, oral antibiotic alone, or none. Cochran-Armitage tests were used for trend analysis. Multivariable analyses stratified by tumor location were performed for the outcome of anastomotic leak. An additional multivariable model including all tumor locations assessed for interaction between bowel preparation and tumor location on an anastomotic leak. RESULTS: A total of 29,739 operations were included and the anastomotic leak rate was 1.9% with combined preparation versus 4.0% without preparation. Combined bowel preparation utilization increased over time as tumor location became more distal (both p < .0001). However, the adjusted effect of combined bowel preparation on anastomotic leak risk reduction did not differ by individual tumor location or across all tumor locations (p = .43 for interaction). CONCLUSION: Though the utilization rate of combined bowel preparation increased as tumor location became more distal, its risk-reducing effect remained similar. Quality improvement initiatives should focus on increased utilization of combined bowel preparation with an emphasis on tumors in the ascending colon.

Extrapolation of ACOSOG Z0011 trial results-A survey of breast cancer providers.

We surveyed breast providers from a national oncology cooperative group to evaluate axillary management recommendations for patients with 1-2 positive sentinel lymph nodes (+SLNs) with scenarios not explicitly included in the Z0011 trial. These scenarios included patients underrepresented (premenopausal, HER2+/triple-negative tumors, and invasive lobular carcinoma) or excluded (treated with mastectomy or neo-adjuvant chemotherapy [NAC]) from the ACOSOG Z0011 trial. Survey response rate was 94/149 (64%). For patients in underrepresented groups, 45-63% of providers recommended no further axillary treatment. For mastectomy patients, 45-55% recommended multi-disciplinary discussion. 83% felt more data are needed to change practice, but 41% believed there would be significant accrual challenges to a clinical trial. For patients treated with NAC, recommendations varied widely. 85% felt more data are needed to change practice, but 26% felt there would be significant accrual challenges. For all scenarios, 86-100% of radiation oncologists recommended axillary radiation, while surgeons more often recommended no further axillary treatment. Traditional randomized trials are likely not feasible to provide answers to these critical management questions, so more pragmatic or big data studies may be needed.

Screening for Anxiety in Adolescent and Adult Women: A Systematic Review for the Women's Preventive Services Initiative.

BACKGROUND: Anxiety disorders are infrequently recognized during routine health care even though they are common in adolescent girls and adult women. PURPOSE: To evaluate evidence on the effectiveness of screening for anxiety disorders in primary care in improving symptoms, function, and quality of life; harms of screening; accuracy of screening instruments; and effectiveness and harms of treatments. DATA SOURCES: English-language searches of Ovid MEDLINE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Health and Psychosocial Instruments (1 January 1996 to 4 November 2019); ClinicalTrials.gov (November 2019); and reference lists of studies and reviews. STUDY SELECTION: Studies that enrolled adolescent girls and adult women not currently diagnosed with anxiety disorders, including pregnant or postpartum women, and compared clinical outcomes and harms between women who were and were not screened; diagnostic accuracy studies of screening instruments; and systematic reviews of randomized trials of behavioral and pharmacologic treatments. DATA EXTRACTION: Dual extraction and quality assessment of individual studies. DATA SYNTHESIS: No studies evaluated the overall effectiveness or harms of screening. Thirty-three studies and 2 systematic reviews (171 studies; 112 574 participants) evaluated the diagnostic accuracy of 27 screening instruments and their variations against a clinical diagnosis or other instruments. Most demonstrated moderate to high accuracy for adults (Generalized Anxiety Disorder scale: sensitivity, 70% to 97%; specificity, 50% to 89%), pregnant and postpartum women (Edinburgh Postnatal Depression Scale: sensitivity, 74%; specificity, 64%), and adolescents (Screen for Child Anxiety Related Emotional Disorders: sensitivity, 64% to 74%; specificity, 64% to 73%). Anxiety symptoms improved with cognitive behavioral therapy (246 randomized controlled trials; 17 209 participants) and antianxiety medications (126 randomized controlled trials; 8225 participants). LIMITATION: Limited data on long-term harms of treatment and no treatment trials in pregnant or postpartum women. CONCLUSION: Evidence on the overall effectiveness and harms of screening for anxiety is insufficient. Most screening instruments are moderately to highly accurate. Behavioral therapies and antianxiety medications effectively improve anxiety symptoms. PRIMARY FUNDING SOURCE: Health Resources and Services Administration.

Achieving Health Equity in Preventive Services: A Systematic Review for a National Institutes of Health Pathways to Prevention Workshop.

Background: Disadvantaged populations in the United States experience disparities in the use of preventive health services. Purpose: To examine effects of barriers that create health disparities in 10 recommended preventive services for adults, and to evaluate the effectiveness of interventions to reduce them. Data Sources: English-language searches of Ovid MEDLINE, PsycINFO, SocINDEX, and the Veterans Affairs Health Services database (1 January 1996 to 5 July 2019); reference lists. Study Selection: Trials, observational studies with comparison groups, and systematic reviews of populations adversely affected by disparities that reported effects of barriers on use of any of the 10 selected preventive services or that reported the effectiveness of interventions to reduce disparities in use of a preventive service by improving intermediate or clinical outcomes. Data Extraction: Dual extraction and assessment of study quality, strength of evidence, and evidence applicability. Data Synthesis: No studies reported effects of provider-specific barriers on preventive service use. Eighteen studies reporting effects of patient barriers, such as insurance coverage or lack of a regular provider, on preventive service use had mixed and inconclusive findings. Studies of patient-provider interventions (n = 12), health information technologies (n = 11), and health system interventions (n = 88) indicated higher cancer screening rates with patient navigation; telephone calls, prompts, and other outreach methods; reminders involving lay health workers; patient education; risk assessment, counseling, and decision aids; screening checklists; community engagement; and provider training. Single studies showed that clinician-delivered and technology-assisted interventions improved rates of smoking cessation and weight loss, respectively. Limitation: Insufficient or low strength of evidence and applicability for most interventions except patient navigation, telephone calls and prompts, and reminders involving lay health workers. Conclusion: In populations adversely affected by disparities, patient navigation, telephone calls and prompts, and reminders involving lay health workers increase cancer screening. Primary Funding Source: National Institutes of Health Office of Disease Prevention through an interagency agreement with the Agency for Healthcare Research and Quality. (PROSPERO: CRD42018109263).

Screening for Anxiety in Adolescent and Adult Women: A Recommendation From the Women's Preventive Services Initiative.

DESCRIPTION: The Women's Preventive Services Initiative (WPSI), a national coalition of women's health professional organizations and patient representatives, developed a recommendation on screening for anxiety in adolescent and adult women to improve detection; achieve earlier diagnosis and treatment; and improve health, function, and well-being. The WPSI's recommendations are intended to guide clinical practice and coverage of services for the Health Resources and Services Administration and other stakeholders. The target audience for this recommendation includes all clinicians providing preventive health care to women, particularly in primary care settings. This recommendation applies to women and adolescent girls aged 13 years or older who are not currently diagnosed with anxiety disorders, including pregnant and postpartum women. METHODS: The WPSI developed this recommendation after evaluating results of a systematic review of the effectiveness of screening, accuracy of screening instruments, and benefits and harms of treatments in adolescent girls and adult women. No studies directly evaluated the overall effectiveness or harms of screening for anxiety. Twenty-seven screening instruments and their variations were moderately to highly accurate in identifying anxiety (33 individual studies and 2 systematic reviews; 171 studies total). Symptoms improved and relapse rates decreased with psychological therapies (246 randomized controlled trials [RCTs] in 5 systematic reviews) and with selective serotonin reuptake inhibitors or selective serotonin and norepinephrine reuptake inhibitors (126 RCTs in 3 systematic reviews). The WPSI also considered the effect of screening on symptom progression and identification of associated and underlying conditions, as well as implementation factors. RECOMMENDATION: The WPSI recommends screening for anxiety in women and adolescent girls aged 13 years or older who are not currently diagnosed with anxiety disorders, including pregnant and postpartum women. Optimal screening intervals are unknown, and clinical judgment should be used to determine frequency. When screening suggests the presence of anxiety, further evaluation is necessary to establish the diagnosis and determine appropriate treatment and follow-up.