COVID-19 impact on screening test volume through the National Breast and Cervical Cancer early detection program, January-June 2020, in the United States.

Women from racial and ethnic minority groups face a disproportionate burden of cervical and breast cancers in the United States. The Coronavirus Disease 2019 (COVID-19) pandemic might exacerbate these disparities as supply and demand for screening services are reduced. The National Breast and Cervical Cancer Early Detection Program (NBCCEDP) provides cancer screening services to women with low income and inadequate health insurance. We examined COVID-19's impact on NBCCEDP screening services during January-June 2020. We found the total number of NBCCEDP-funded breast and cervical cancer screening tests declined by 87% and 84%, respectively, during April 2020 compared with the previous 5-year averages for that month. The extent of declines varied by geography, race/ethnicity, and rurality. In April 2020, screening test volume declined most severely in Health and Human Services Region 2 - New York (96% for breast, 95% for cervical cancer screening) compared to the previous 5-year averages. The greatest declines were among American Indian/Alaskan Native women for breast cancer screening (98%) and Asian Pacific Islander women for cervical cancer screening (92%). Test volume began to recover in May and, by June 2020, NBCCEDP breast and cervical cancer screening test volume was 39% and 40% below the 5-year average for that month, respectively. However, breast cancer screening remained over 50% below the 5-year average among women in rural areas. NBCCEDP programs reported assisting health care providers resume screening.

The effectiveness of targeting never or rarely screened women in a national cervical cancer screening program for underserved women.

PURPOSE: To evaluate the effectiveness of a policy supporting early detection and prevention of cervical cancer among low-income and uninsured women by comparing women who reported never or rarely being screened (last screen >5 years) to those who reported screening in the past ≤5 years. METHODS: We analyzed data from 1,485,251 women who received their first Pap test in the National Breast and Cervical Cancer Early Detection Program (NBCCEDP) from July 2002 through June 2012. Of these, 461,893 women (31 %) reported being never or rarely screened and 1,023,358 (69 %) reported being screened in the past 5 years. Demographic (age, race/ethnicity, residence, and region) and clinic (cytologic and histologic results) characteristics were examined for the two groups. RESULTS: Women who were aged ≥50 years, Asian and Pacific Islander, American Indian or Alaska Native, multiracial, living in non-metro areas, or living in the South or a territory were more likely to report being never or rarely screened. The percentage of abnormal Pap tests and the rate of precancer and cancer (combined) was higher in the never or rarely screened group compared with the screened group (abnormal percentage: 2.9 vs 2.6 %, p value < 0.01; rate of precancer and cancer: 6.9 vs 3.7 per 1,000 women, p value < 0.01). CONCLUSIONS: The priority of reaching never or rarely screened women should continue since those women who entered the NBCCEDP not adequately screened had a greater prevalence of high-grade histological lesions and invasive cervical cancers at later stages than women screened more recently.

Risk factors for the development of placebo adverse reactions in a multicenter clinical trial.

In this report, we examine the potential risk factors for both the incidence and the number of placebo adverse reactions among patients who were enrolled in the placebo control group in a multicenter clinical trial (n = 491). Of the nine baseline covariates analyzed, only clinical center was significantly related to both the presence and the number of adverse reactions. Placebo group patients at clinical centers 5 and 7 were more than twice as likely to experience an adverse reaction than were patients at clinical center 1. This finding, in light of the intensive effort we made to standardize the methods for adverse reaction detection and management, points out the difficulty in controlling for the inherent differences in the characteristics of the patient populations and clinic personnel at the clinical centers in a multicenter trial, and reinforces the need to stratify by clinical center prior to randomization.

Clinical and laboratory adverse effects associated with long-term, low-dose isotretinoin: incidence and risk factors. The Isotretinoin-Basal Cell Carcinomas Study Group.

Adverse effects associated with the long-term low-dose regimens of retinoids used in cancer chemoprevention studies are not well described. In order to examine the clinical and laboratory adverse effects of 3 years of intervention with isotretinoin (10 mg/day) and to assess potential risk factors for developing these, we collected adverse effect data on patients participating in a randomized, placebo-controlled trial designed to evaluate the effectiveness of isotretinoin in preventing the subsequent occurrence of new basal cell carcinoma. Our results showed a significantly higher incidence of adverse mucocutaneous effects and serum triglyceride elevations in the isotretinoin group (P < 0.001). Associated risk factors included male gender, very fair skin, and elevated pretreatment triglyceride levels. The toxicity observed, although less severe and less frequent, was similar to that seen with higher doses and should be weighed with adverse skeletal effects when considering long-term treatment of patients with moderate cancer risk.

Skeletal hyperostosis in patients receiving chronic, very-low-dose isotretinoin.

BACKGROUND AND DESIGN: We conducted a prospective roentgenographic survey of patients participating in a randomized, placebo-controlled, multicenter clinical trial that evaluated the effectiveness of chronic, very-low-dose (approximately 0.14 mg/kg per day for 3 years) isotretinoin in preventing the subsequent occurrences of new basal cell carcinoma in patients with previous basal cell carcinoma. To assess potential skeletal changes, a sample of 269 patients from among a total of 981 enrollees were randomly selected for comparative roentgenographic review. Baseline and 36-month roentgenograms of the cervical and thoracic spine of each patient were read side by side by a radiologist, masked to treatment group, who noted both the presence and extent of abnormalities at each vertebral level at baseline and the progression of existing or occurrence of new abnormalities at previously unaffected levels at 36 months. RESULTS: In comparison with the placebo group, significantly more patients in the isotretinoin group exhibited progression of existing hyperostotic abnormalities (40% vs 18%; P less than .001) and new hyperostotic involvement at previously unaffected vertebral levels (8% vs 1%; P = .015). CONCLUSION: Our findings indicate that chronic, very-low-dose isotretinoin can induce hyperostotic axial skeletal changes similar to those reported in patients taking higher doses.

Patients' perceptions on participation in a cancer chemoprevention trial.

The perceptions of patients regarding the benefits, disadvantages, and importance of their participation in a long-term cancer chemoprevention trial, the Isotretinoin-Basal Cell Carcinoma Prevention Trial, were assessed through a questionnaire mailed at the conclusion of the 3-year treatment period of the trial. Responses were evaluated overall, as well as within subgroups defined by sex, age, education level, treatment group, presence of side effects, and the number of skin biopsies performed during the 3-year intervention phase. Overall, "careful medical follow-up received" (43%) and "being part of a research effort" (24%) were the most frequently cited important benefits, while the "amount of time taken to attend clinic" (32%) and "side effects" (20%) were the most frequently cited unpleasant aspects of trial participation. Most surveyed patients viewed the study as "very or extremely important" to their general health (62%) and their skin cancer condition (88%) and, as a result of participation, felt "much or somewhat better" physically (52%). The majority indicated that they would "definitely or probably" be willing to take part in another research study (79%) and take the study medication, if it were shown to be effective in the trial (78%). Overall and subgroup data provide important insights into patient motivations and attitudes regarding cancer chemoprevention trial participation, adherence, and satisfaction.

The Aberrant Behavior Checklist with children and adolescents with dual diagnosis.

The Aberrant Behavior Checklist (ABC; Aman, Singh, Stewart, & Field, 1985a, 1985b) is a 58-item third-party informant rating scale originally developed for institutionalized, low-functioning adolescents and adults. The present study investigated the appropriateness of the scale for youngsters with dual diagnosis of mental retardation and psychiatric disturbance. Over a period of 2 1/2 years, 204 patients (199 after data reduction) from a child psychiatry unit were rated twice daily by direct care staff. Data analysis addressed internal consistency, interrater reliability, criterion validity, and robustness of the factor structure. Internal consistency was satisfactory with alpha coefficients ranging from .82 to .94. Interrater reliability varied between subscales but was relatively low (Pearson correlations between .39 to .61). In terms of its criterion validity, the ABC was sensitive to psychiatric diagnoses and age and the original 5-factor structure was robust (congruence coefficients ranged between .80 to .89). Yet, only a relatively small proportion of the variance (31.5%) was explained by factor analysis indicating possible limitations of the ABC for this population. Given the paucity of assessment instruments for this particular population and the difficulty involved in developing new population-specific instruments, the ABC can be recommended for children and adolescents with dual diagnosis.

Physical activity and risk of large bowel cancer in the Framingham Study.

We examined the relation between self-reported physical activity and large bowel cancer in a prospective cohort of men and women who participated in the Framingham Study. Self-assessments of physical activity were available from the fourth biennial examination on a total of 1906 men and 2308 women aged 30 to 62 yr in 1954. The cohort was followed for up to 28 yr and yielded 152 cases (73 men, 79 women) of large bowel cancer. Inactivity was associated with an increased risk of large bowel cancer among men but not among women. The relative risk estimates for large bowel cancer among men in the middle and lowest tertiles of a physical activity index (compared with the highest tertile) were 1.4 (95% confidence intervals, 0.8-2.6) and 1.8 (1.0-3.2), respectively. Among women the comparable estimates were 1.2 (0.7-2.1) and 1.1 (0.6-1.8), respectively. These findings were unchanged after adjustment for body mass index, serum cholesterol, alcohol, and other potentially confounding variables. The narrow range of physical activity and the minimal heavy activity reported by women in this cohort may have limited our ability to detect an association between physical activity and large bowel cancer among women.

Body fat distribution and breast cancer in the Framingham Study.

We examined the relation between central body fat distribution and breast cancer in a prospective cohort of women who participated in the Framingham Study. At the baseline examination in 1948, a total of 2,201 women aged 30-62 years were analyzed. An index of central to peripheral body fat (the central adiposity ratio) was calculated from the sum of the trunkal skinfolds (chest, subscapular, and abdominal) divided by the sum of the extremity skinfolds (triceps and thigh). These skinfolds were measured at the fourth examination in 1954. The cohort was followed for up to 28 years and yielded 106 cases of breast cancer. When divided into quartiles based on the central adiposity ratio, only women in the fourth quartile (those with the highest central to peripheral body fat distribution) demonstrated an increased risk for breast cancer. The age- and adiposity-adjusted relative risk estimate for having an increased central adiposity ratio (fourth quartile) compared to lower central adiposity ratios was 1.8 (95% confidence interval, 1.2-2.6). Adjustment for potential confounders of height, parity, and education did not appreciably alter this estimate (1.7, 1.1-2.5). There was no association between degree of adiposity, as measured by the sum of the five skinfolds or by body mass index (weight in kg divided by height in m2), and subsequent breast cancer. The results of this study suggest that increased central to peripheral body fat distribution predicts breast cancer risk independently of the degree of adiposity and may be a more specific marker of a premalignant hormonal pattern than degree of adiposity.

Treatment of ADDH in mentally retarded children: a preliminary study.

The use of CNS stimulant medication for the treatment of attention deficit disorder with hyperactivity (ADDH) in subnormal intelligence children remains controversial, and the majority of the literature does not support the use of CNS stimulants in these children, although the choice of dependent variables and research designs may have contributed to this outcome. A single case research design was used to assess the effectiveness of CNS stimulant medication (methylphenidate and dextroamphetamine) in three subnormal intelligence children with ADDH, using excessive movement and on-task behaviors as dependent variables. The results and implications for future research are discussed.

Is alcohol consumption related to breast cancer? Results from the Framingham Heart Study.

We studied the relation between alcohol consumption and breast cancer among women in the Framingham Heart Study cohort. A total of 2,636 women aged 31-64 years provided information on alcohol consumption at the second biennial examination. They were followed for up to 32 years; during this period, breast cancer was diagnosed in 143 of these women. Alcohol intake was also assessed at 10 and 20 years of follow-up and every 2 years thereafter. In analyses using only baseline alcohol intake, the multiple risk factor-adjusted relative risk (RR) estimate of breast cancer for any drinking, compared with nondrinking, was 0.8 [95% confidence interval (CI), 0.5-1.1]. For three levels of alcohol intake (0.1-1.4 g/day, 1.5-4.9 g/day, and greater than or equal to 5.0 g/day), the baseline analyses yielded RRs (vs. nondrinking) of 1.0 (CI, 0.6-1.5), 0.7 (CI, 0.4-1.1), and 0.6 (CI, 0.4-1.0), respectively. In analyses incorporating repeated measures of alcohol, the comparable RRs were 0.9 (CI, 0.6-1.2) for any drinking (vs. nondrinking) and 0.7 (CI, 0.4-1.4), 1.1 (CI, 0.7-1.8), and 0.8 (CI, 0.5-1.2), respectively, for the three levels of intake (vs. nondrinking). Alcohol consumption was not associated with an increased risk of breast cancer in this cohort.

Aversive conditioning of visual screening with aromatic ammonia for treating aggressive and disruptive behavior in a developmentally disabled child.

This study investigated the usefulness of aversive conditioning of a mild punishment procedure that had ceased to suppress target behaviors to clinically acceptable levels. A 6.8-year-old severely retarded boy with high levels of aggressive, destructive, and loud screeching behaviors was readmitted to a psychiatric facility to adjust behavioral programs and rule out seizure disorder. A design combining withdrawal and multiple baselines across behaviors tested for effects of aversive conditioning of visual screening with ammonia and the impact of anticonvulsant medication (carbamazepine, phenytoin). Data indicated that aversively conditioned visual screening temporarily lowered rates of responding. It is tentatively concluded that aversive conditioning might be a useful mechanism to strengthen suppressive effects of mild punishment procedures and a promising approach for alleviating placement problems due to maladaptive behaviors in mentally retarded persons. Maintenance of treatment effects, community placement, and the mandate to choose the least restrictive aversive treatment alternative are discussed. Anticonvulsant medication showed no beneficial effect for the target behaviors investigated.

The relationship of depression to social skills and intellectual functioning in mentally retarded adults.

Ninety-nine mild to severely mentally retarded adults were evaluated on a variety of measures. The battery included the Peabody Picture Vocabulary Test-Revised (PPVT), the Psychopathology Instrument for Mentally Retarded Adults, the Social Performance Survey Schedule, Hamilton Rating Scale of Depression, the Beck Depression Inventory and Zung Self-Rating Depression Scale. Depression and social skills measures correlated significantly with each other on self-report and informant reports. Receptive vocabulary did not significantly correlate with depression or social skills measures, irrespective of self or other report format. Additionally, demographic variables such as intellectual level were not significant. The PPVT mean scores differed significantly by level of mental retardation as might be expected. The significance of these data and their implication for further study are reviewed.

Depression in mentally retarded children.

Thirty-one mentally retarded emotionally disturbed children, hospitalized within a university medical school's psychiatric intensive care program, were matched on age and sex and compared to 31 children from a normal school setting on depression. Measures included the Child Depression Inventory (CDI) and the Child Behavior Profile (CBP), with children being compared on total and subfactor scores for both measures. Depression and its various subcomponents were more prevalent in the mentally retarded group. There were no significant sex or age differences. Degree of overall psychopathology and depression were highly related. The relationship between criteria for depression on the CDI and CBC were also made. Correlational data showed a strong relationship between the cut-off scores for both measures, an important finding because they were based on norms established with children of normal intelligence. These data suggest that similarities exist between depression in mentally retarded children and those without such cognitive handicaps. The relationship of depression to other forms of psychopathology in the group of 31 emotionally disturbed mentally retarded children was also examined. A wide range of disorders including schizophrenia, aggression, withdrawal, and hyperactivity were evaluated. These are the first empirical data with mentally retarded children in the United States that are aimed specifically at evaluating depression, and should be useful to the clinicians in better understanding the phenomenon.

Psychometric properties of the Matson Evaluation of Social Skills with Youngsters (MESSY) with emotional problems and self concept in deaf children.

In Study One the Matson Evaluation of Social Skills with Youngsters (MESSY) was scored by teachers for 96 deaf children ranging from normal intelligence through mentally retarded. Inter-item and split-half correlations were high, and internal consistency of particular items correlated to the scale as a whole was high. Items that were particularly spurious were looking and smiling at others, an interesting finding since these social behaviors are frequently targeted in treatment research. Therefore, re-evaluating behaviors which should receive priority for treatment may need to be considered at least with deaf children. In Study Two, these children were evaluated on social (MESSY) and emotional behavior (AML), and self-concept (Piers-Harris). Correlations between scales showed the greatest relationship between social and emotional responses. The implications of these data are discussed.