Implementing Survivorship Care Plans for Colon Cancer Survivors

To evaluate the feasibility, usability, and satisfaction of a survivorship care plan (SCP) and identify the optimum time for its delivery during the first 12 months after diagnosis

Mental and Physical Health-Related Quality of Life among U.S. Cancer Survivors: Population Estimates from the 2010 National Health Interview Survey

Despite extensive data on health-related quality of life (HRQOL) among cancer survivors, we do not yet have an estimate of the percent of survivors with poor mental and physical HRQOL compared to population norms. HRQOL population means for adult-onset cancer survivors of all ages and across the survivorship trajectory also have not been published

Etravirine pharmacokinetics in HIV-infected pregnant women

__Background__ The study goal was to describe etravirine pharmacokinetics during pregnancy and postpartum in HIV-infected women. __Methods__ IMPAACT P1026s and PANNA are on-going, non-randomized, open-label, parallel-group, multi-center phase-IV prospective studies in HIV-infected pregnant women. Intensive steady-state 12-h pharmacokinetic profiles were performed from 2nd trimester through postpartum. Etravirine was measured at two labs using validated ultra performance liquid chromatography (detection limits: 0.020 and 0.026 mcg/mL). __Results__ Fifteen women took etravirine 200 mg twice-daily. Etravirine AUC0-12 was higher in the 3rd trimester compared to paired postpartum data by 34% (median 8.3 vs. 5.3 mcg*h/mL, p = 0.068). Etravirine apparent oral clearance was significantly lower in the 3rd trimester of pregnancy compared to paired postpartum data by 52% (median 24 vs. 38 L/h, p = 0.025). The median ratio of cord blood to maternal plasma concentration at delivery was 0.52 (range: 0.19-4.25) and no perinatal transmission occurred. __Conclusion__ Etravirine apparent oral clearance is reduced and exposure increased during the third trimester of pregnancy. Based on prior dose-ranging and safety data, no dose adjustment is necessary for maternal health but the effects of etravirine in utero are unknown. Maternal health and infant outcomes should be closely monitored until further infant safety data are available. __Clinical Trial registration:__ The IMPAACT protocol P1026s and PANNA study are registered at ClinicalTrials.gov under NCT00042289 and NCT00825929

Effect of Hydrocortisone on Mortality and Organ Support in Patients With Severe COVID-19: The REMAP-CAP COVID-19 Corticosteroid Domain Randomized Clinical Trial.

Importance: Evidence regarding corticosteroid use for severe coronavirus disease 2019 (COVID-19) is limited. Objective: To determine whether hydrocortisone improves outcome for patients with severe COVID-19. Design, Setting, and Participants: An ongoing adaptive platform trial testing multiple interventions within multiple therapeutic domains, for example, antiviral agents, corticosteroids, or immunoglobulin. Between March 9 and June 17, 2020, 614 adult patients with suspected or confirmed COVID-19 were enrolled and randomized within at least 1 domain following admission to an intensive care unit (ICU) for respiratory or cardiovascular organ support at 121 sites in 8 countries. Of these, 403 were randomized to open-label interventions within the corticosteroid domain. The domain was halted after results from another trial were released. Follow-up ended August 12, 2020. Interventions: The corticosteroid domain randomized participants to a fixed 7-day course of intravenous hydrocortisone (50 mg or 100 mg every 6 hours) (n = 143), a shock-dependent course (50 mg every 6 hours when shock was clinically evident) (n = 152), or no hydrocortisone (n = 108). Main Outcomes and Measures: The primary end point was organ support-free days (days alive and free of ICU-based respiratory or cardiovascular support) within 21 days, where patients who died were assigned -1 day. The primary analysis was a bayesian cumulative logistic model that included all patients enrolled with severe COVID-19, adjusting for age, sex, site, region, time, assignment to interventions within other domains, and domain and intervention eligibility. Superiority was defined as the posterior probability of an odds ratio greater than 1 (threshold for trial conclusion of superiority >99%). Results: After excluding 19 participants who withdrew consent, there were 384 patients (mean age, 60 years; 29% female) randomized to the fixed-dose (n = 137), shock-dependent (n = 146), and no (n = 101) hydrocortisone groups; 379 (99%) completed the study and were included in the analysis. The mean age for the 3 groups ranged between 59.5 and 60.4 years; most patients were male (range, 70.6%-71.5%); mean body mass index ranged between 29.7 and 30.9; and patients receiving mechanical ventilation ranged between 50.0% and 63.5%. For the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively, the median organ support-free days were 0 (IQR, -1 to 15), 0 (IQR, -1 to 13), and 0 (-1 to 11) days (composed of 30%, 26%, and 33% mortality rates and 11.5, 9.5, and 6 median organ support-free days among survivors). The median adjusted odds ratio and bayesian probability of superiority were 1.43 (95% credible interval, 0.91-2.27) and 93% for fixed-dose hydrocortisone, respectively, and were 1.22 (95% credible interval, 0.76-1.94) and 80% for shock-dependent hydrocortisone compared with no hydrocortisone. Serious adverse events were reported in 4 (3%), 5 (3%), and 1 (1%) patients in the fixed-dose, shock-dependent, and no hydrocortisone groups, respectively. Conclusions and Relevance: Among patients with severe COVID-19, treatment with a 7-day fixed-dose course of hydrocortisone or shock-dependent dosing of hydrocortisone, compared with no hydrocortisone, resulted in 93% and 80% probabilities of superiority with regard to the odds of improvement in organ support-free days within 21 days. However, the trial was stopped early and no treatment strategy met prespecified criteria for statistical superiority, precluding definitive conclusions. Trial Registration: ClinicalTrials.gov Identifier: NCT02735707

Effect of angiotensin-converting enzyme inhibitor and angiotensin receptor blocker initiation on organ support-free days in patients hospitalized with COVID-19

IMPORTANCE Overactivation of the renin-angiotensin system (RAS) may contribute to poor clinical outcomes in patients with COVID-19. Objective To determine whether angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) initiation improves outcomes in patients hospitalized for COVID-19. DESIGN, SETTING, AND PARTICIPANTS In an ongoing, adaptive platform randomized clinical trial, 721 critically ill and 58 non–critically ill hospitalized adults were randomized to receive an RAS inhibitor or control between March 16, 2021, and February 25, 2022, at 69 sites in 7 countries (final follow-up on June 1, 2022). INTERVENTIONS Patients were randomized to receive open-label initiation of an ACE inhibitor (n = 257), ARB (n = 248), ARB in combination with DMX-200 (a chemokine receptor-2 inhibitor; n = 10), or no RAS inhibitor (control; n = 264) for up to 10 days. MAIN OUTCOMES AND MEASURES The primary outcome was organ support–free days, a composite of hospital survival and days alive without cardiovascular or respiratory organ support through 21 days. The primary analysis was a bayesian cumulative logistic model. Odds ratios (ORs) greater than 1 represent improved outcomes. RESULTS On February 25, 2022, enrollment was discontinued due to safety concerns. Among 679 critically ill patients with available primary outcome data, the median age was 56 years and 239 participants (35.2%) were women. Median (IQR) organ support–free days among critically ill patients was 10 (–1 to 16) in the ACE inhibitor group (n = 231), 8 (–1 to 17) in the ARB group (n = 217), and 12 (0 to 17) in the control group (n = 231) (median adjusted odds ratios of 0.77 [95% bayesian credible interval, 0.58-1.06] for improvement for ACE inhibitor and 0.76 [95% credible interval, 0.56-1.05] for ARB compared with control). The posterior probabilities that ACE inhibitors and ARBs worsened organ support–free days compared with control were 94.9% and 95.4%, respectively. Hospital survival occurred in 166 of 231 critically ill participants (71.9%) in the ACE inhibitor group, 152 of 217 (70.0%) in the ARB group, and 182 of 231 (78.8%) in the control group (posterior probabilities that ACE inhibitor and ARB worsened hospital survival compared with control were 95.3% and 98.1%, respectively). CONCLUSIONS AND RELEVANCE In this trial, among critically ill adults with COVID-19, initiation of an ACE inhibitor or ARB did not improve, and likely worsened, clinical outcomes. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT0273570

Provider beliefs associated with cervical cancer screening interval recommendations: A pilot study in Federally Qualified Health Centers

Background: Among providers who serve low-income and uninsured women, resistance to extending the cervical cancer screening interval following normal Pap and co-test results has been documented. Our objective was to examine provider characteristics and beliefs associated with guideline-consistent screening interval recommendations. Method: We collected cross-sectional survey data between 2009 and 2010 from 82 primary care providers in six Federally Qualified Health Centers in Illinois, USA. The relationships between characteristics, beliefs, and screening interval recommendations (1 year vs. 3 years) were tested with Pearson chi-square, negative binomial and ordered logistic regression. Results: Compared to providers who recommended annual intervals after a normal co-test, providers who recommended a guideline-consistent (i.e., 3 years) screening interval were significantly more likely to report the goodness, ease, and benefit of their recommendation and perceived encouragement for a 3-year interval from professional organizations and journals (p < .05). Providers who recommended a 3-year interval were also less likely to report that longer intervals increase patient risk for cervical cancer (p < .05). Interval recommendations were not associated with provider specialty, gender, or years in practice. Conclusion: Messages that promote the benefits of longer screening intervals after a normal co-test, the natural history of human papillomavirus and cervical cancer, and low risk of developing cancer with a longer interval may be useful to promote evidence-based screening in this population of Federally Qualified Health Center providers. Dissemination of targeted messages through professional journals and specialty organizations should be considered

Breast and Colorectal Cancer Screening and Sources of Cancer Information Among Older Women in the United States: Results From the 2003 Health Information National Trends Survey

IntroductionThe number of people in the United States aged 65 years and older is increasing. Older people have a higher risk of dying from cancer; however, recent information about breast and colorectal cancer screening rates among women aged 65 years and older and about sources of health information consulted by these women is limited.MethodsWe examined data from the Health Information National Trends Survey for women aged 65 years and older who had no personal history of breast or colorectal cancer. Women whose self-reported race and ethnicity was non-Hispanic white, non-Hispanic black, or Hispanic were included in the analysis. The overall response rate for the 2003 survey was 34.5%.ResultsWomen aged 75 years and older had lower rates of recent mammography (mammogram in previous 2 years) than did women aged 65 to 74 years. In both age groups, rates were especially low for Hispanic women and women with a household income of less than $15,000 per year. Rates of recent colorectal cancer screening (fecal occult blood test in previous year or endoscopy in previous 5 years) were markedly lower for non-Hispanic black women aged 75 years and older than for other women in this age group, and for Hispanic women aged 65 to 74 years than for non-Hispanic women in this age group. Screening rates were lowest for women with an annual household income of less than$15,000, no family history of cancer, no usual health care provider, or 1 or no provider visits in the previous year.Differences were found in the groups’ preferred channel for receiving health information. Women who had had a mammogram in the previous 2 years were more likely to pay attention to health information on the radio or in newspapers and magazines than were women who had not received a recent mammogram. Women who had had a recent colorectal cancer screening test were more likely to pay attention to health information in magazines or on the Internet than were those who had not. Personalized print and other publications were the most preferred channel for receiving health information.ConclusionThe results from this analysis suggest that educational materials about routine breast and colorectal cancer screening appropriate for women aged 65 years and older (especially low-income women, Hispanic women, and those aged 65 to 74 years) may be helpful

Communication practices about HPV testing among providers in Federally Qualified Health Centers

Objective: Little is known about the information providers share with patients when ordering a co-test, or combined human papillomavirus (HPV) and Papanicolaou (Pap) test, for cervical cancer screening. We assessed provider perceptions of such communication practices with female patients aged 30–60 years. Methods: We analyzed data from 98 providers in 15 Federally Qualified Health Center clinics across Illinois (2009–2010). Results: About 70% of the providers reported that when ordering a co-test, they would usually or always communicate information about the HPV test to their patients, explain the test detects a sexually transmitted infection, and discuss how the test results may determine their next screening interval. Most (>85%) reported that they were comfortable discussing co-test results. Compared with concordant positive results (HPV positive/Pap positive), providers were more likely to perceive that discordant results (HPV positive/Pap negative) would be too complex for patients to understand (25% vs. 15%, p = 0.006), and make patients feel less assured that they were getting the best standard of care (67% vs. 88%, p < 0.001). Conclusion: As HPV testing plays a more prominent role in cervical cancer screening, more attention should be given to communications between providers and patients about the benefits and harms of different screening options