Unsatisfactory Fecal Immunochemical Tests for Colorectal Cancer Screening: Prevalence, Reasons, and Subsequent Testing.

BACKGROUND: Fecal immunochemical test (FIT) is an effective colorectal cancer screening modality. Little is known about prevalence, reasons, and testing after unsatisfactory FIT, or a FIT that cannot be processed by the laboratory due to inadequate stool specimen or incomplete labeling. METHODS: Our retrospective cohort study examined unsatisfactory FIT among average-risk individuals aged 50-74 years in a large, integrated, safety-net health system who completed an index FIT from 2010 to 2019. We determined prevalence of unsatisfactory FIT and categorized reasons hierarchically. We used multivariable logistic regression models to identify factors associated with: (i) unsatisfactory FIT; and (ii) subsequent testing within 15 months of the unsatisfactory FIT. RESULTS: Of 56,980 individuals completing an index FIT, 10.2% had an unsatisfactory FIT. Reasons included inadequate specimen (51%), incomplete labeling (27%), old specimen (13%), and broken/leaking container (8%). Unsatisfactory FIT was associated with being male [OR, 1.10; confidence interval (CI), 1.03-1.16], Black (OR, 1.46; CI, 1.33-1.61), Spanish speaking (OR, 1.12; CI, 1.01-1.24), on Medicaid (OR, 1.42; CI, 1.28-1.58), and received FIT by mail (OR, 2.66; CI, 2.35-3.01). Among those with an unsatisfactory FIT, fewer than half (41%) completed a subsequent test within 15 months (median, 4.4 months). Adults aged 50-54 years (OR, 1.16; CI, 1.01-1.39) and those who received FIT by mail (OR, 1.92; CI, 1.49-2.09) were more likely to complete a subsequent test. CONCLUSIONS: One in ten returned a FIT that could not be processed, mostly due to patient-related reasons. Fewer than half completed a subsequent test after unsatisfactory FIT. IMPACT: Screening programs should address these breakdowns such as specimen collection and labeling to improve real-world effectiveness. See related In the Spotlight, p. 183.

Improving Colorectal Cancer Screening in a Regional Safety-Net Health System over a 10-Year Period: Lessons for Population Health.

BACKGROUND: Despite national policy efforts to increase colorectal cancer (CRC) screening, rates in vulnerable populations remain suboptimal. Many types of interventions have been employed, but their impact on improving population-level rates of CRC screening over time is uncertain. OBJECTIVE: Assess the impact of 10 years of different in-reach and outreach strategies to improve CRC screening and identify factors associated with being screen up-to-date (SUTD). DESIGN: Observational cohort study. PARTICIPANTS: Patients aged 50-74 years from 12 community-based primary care clinics in an integrated, regional safety-net health system. INTERVENTIONS: Multiple system-level interventions were implemented over time (visit-based electronic health record [EHR] reminders, quality measurement, annual preventive service letters, and mailed fecal immunohistochemical stool tests [FIT]). MAIN MEASURES: CRC SUTD rates by calendar year among those with a primary care (PC) visit in the prior 1 and 3 years and their multivariable correlates. KEY RESULTS: The sample included 31,786-40,405 patients/year. In 2011, mean age was 58.9, 63.9% were women, 37.0% were Hispanic, 39.3% Black, 16.8% White, and 6.6% Asian/Other, and 60.5% were uninsured/Medicaid. Three-quarters of patients had ≥ 1 PC visit in the prior year. Lower-intensity interventions (EHR reminders, quality measurement, annual prevention letters) had limited impact on SUTD rates (2-3% rise). Implementing system-wide mailed FIT increased rates from 51.2 to 61.9% among those with a PC visit in the past year (40.5 to 46.8% with a PC visit ≤ 3 years). Stopping mailed FIT due to COVID wiped out these gains. Higher screening rates were associated with the following: older age; female; more comorbidities, PC clinic visits, and prior FITs; and better insurance coverage. Hispanics had the highest SUTD rates followed by Asians, Blacks, and Whites (p < 0.05). CONCLUSIONS: Implementation of a system-wide mailed FIT program had the greatest impact on SUTD rates. Lower-intensity interventions (EHR reminders, quality measurement, and patient letters) had limited effects.

Racial and Ethnic Disparities in Cervical Cancer Screening From Three U.S. Healthcare Settings.

INTRODUCTION: This study sought to characterize racial and ethnic disparities in cervical cancer screening and follow-up of abnormal findings across 3 U.S. healthcare settings. METHODS: Data were from 2016 to 2019 and were analyzed in 2022, reflecting sites within the Multi-level Optimization of the Cervical Cancer Screening Process in Diverse Settings & Populations Research Center, part of the Population-based Research to Optimize the Screening Process consortium, including a safety-net system in the southwestern U.S., a northwestern mixed-model system, and a northeastern integrated healthcare system. Screening uptake was evaluated among average-risk patients (i.e., no previous abnormalities) by race and ethnicity as captured in the electronic health record, using chi-square tests. Among patients with abnormal findings requiring follow-up, the proportion receiving colposcopy or biopsy within 6 months was reported. Multivariable regression was conducted to assess how clinical, socioeconomic, and structural characteristics mediate observed differences. RESULTS: Among 188,415 eligible patients, 62.8% received cervical cancer screening during the 3-year study period. Screening use was lower among non-Hispanic Black patients (53.2%) and higher among Hispanic (65.4%,) and Asian/Pacific Islander (66.5%) than among non-Hispanic White patients (63.5%, all p<0.001). Most differences were explained by the distribution of patients across sites and differences in insurance. Hispanic patients remained more likely to screen after controlling for a variety of clinical and sociodemographic factors (risk ratio=1.14, CI=1.12, 1.16). Among those receiving any screening test, Black and Hispanic patients were more likely to receive Pap-only testing (versus receiving co-testing). Follow-up from abnormal results was low for all groups (72.5%) but highest among Hispanic participants (78.8%, p<0.001). CONCLUSIONS: In a large cohort receiving care across 3 diverse healthcare settings, cervical cancer screening and follow-up were below 80% coverage targets. Lower screening for Black patients was attenuated by controlling for insurance and site of care, underscoring the role of systemic inequity. In addition, it is crucial to improve follow-up after abnormalities are identified, which was low for all populations.

Evaluation of Harms Reporting in U.S. Cancer Screening Guidelines.

BACKGROUND: Cancer screening should be recommended only when the balance between benefits and harms is favorable. This review evaluated how U.S. cancer screening guidelines reported harms, within and across organ-specific processes to screen for cancer. OBJECTIVE: To describe current reporting practices and identify opportunities for improvement. DESIGN: Review of guidelines. SETTING: United States. PATIENTS: Patients eligible for screening for breast, cervical, colorectal, lung, or prostate cancer according to U.S. guidelines. MEASUREMENTS: Information was abstracted on reporting of patient-level harms associated with screening, diagnostic follow-up, and treatment. The authors classified harms reporting as not mentioned, conceptual, qualitative, or quantitative and noted whether literature was cited when harms were described. Frequency of harms reporting was summarized by organ type. RESULTS: Harms reporting was inconsistent across organ types and at each step of the cancer screening process. Guidelines did not report all harms for any specific organ type or for any category of harm across organ types. The most complete harms reporting was for prostate cancer screening guidelines and the least complete for colorectal cancer screening guidelines. Conceptualization of harms and use of quantitative evidence also differed by organ type. LIMITATIONS: This review considers only patient-level harms. The authors did not verify accuracy of harms information presented in the guidelines. CONCLUSION: The review identified opportunities for improving conceptualization, assessment, and reporting of screening process-related harms in guidelines. Future work should consider nuances associated with each organ-specific process to screen for cancer, including which harms are most salient and where evidence gaps exist, and explicitly explore how to optimally weigh available evidence in determining net screening benefit. Improved harms reporting could aid informed decision making, ultimately improving cancer screening delivery. PRIMARY FUNDING SOURCE: National Cancer Institute.

Evaluating and Improving Cancer Screening Process Quality in a Multilevel Context: The PROSPR II Consortium Design and Research Agenda.

BACKGROUND: Cancer screening is a complex process involving multiple steps and levels of influence (e.g., patient, provider, facility, health care system, community, or neighborhood). We describe the design, methods, and research agenda of the Population-based Research to Optimize the Screening Process (PROSPR II) consortium. PROSPR II Research Centers (PRC), and the Coordinating Center aim to identify opportunities to improve screening processes and reduce disparities through investigation of factors affecting cervical, colorectal, and lung cancer screening in U.S. community health care settings. METHODS: We collected multilevel, longitudinal cervical, colorectal, and lung cancer screening process data from clinical and administrative sources on >9 million racially and ethnically diverse individuals across 10 heterogeneous health care systems with cohorts beginning January 1, 2010. To facilitate comparisons across organ types and highlight data breadth, we calculated frequencies of multilevel characteristics and volumes of screening and diagnostic tests/procedures and abnormalities. RESULTS: Variations in patient, provider, and facility characteristics reflected the PROSPR II health care systems and differing target populations. PRCs identified incident diagnoses of invasive cancers, in situ cancers, and precancers (invasive: 372 cervical, 24,131 colorectal, 11,205 lung; in situ: 911 colorectal, 32 lung; precancers: 13,838 cervical, 554,499 colorectal). CONCLUSIONS: PROSPR II's research agenda aims to advance: (i) conceptualization and measurement of the cancer screening process, its multilevel factors, and quality; (ii) knowledge of cancer disparities; and (iii) evaluation of the COVID-19 pandemic's initial impacts on cancer screening. We invite researchers to collaborate with PROSPR II investigators. IMPACT: PROSPR II is a valuable data resource for cancer screening researchers.

Prevalence and correlates of false-positive results after 3-D screening mammography among uninsured women in a community outreach program.

False-positive results have been rarely investigated among uninsured minority women who undergo 3-D screening mammography. Here, we analyzed data from 21,022 women participating in the Breast Screening and Patient Navigation (BSPAN) program of North Texas with an aim to report prevalence and correlates of false-positive results after 3-D screening mammography, stratified by age. False-positives were defined as a negative diagnostic mammogram or a negative biopsy within 1 year of a positive screen. We used multivariable logistic regression to assess associations of demographic and clinical covariates and false positive results for age groups 40-49 and 50-64 years. Prevalence of false-positive results was 11.8% and 9.6% in the 40-49 and 50-64 age groups, respectively. Multivariable logistic regression demonstrated that, in the 40-49 age group, women who were non-menopausal, did not use hormone replacement therapy (HRT), and had self-reported prior mammograms had higher odds of false-positive results than those who were menopausal, used HRT and had no self-reported prior mammograms, respectively. In the 50-64 age group, women with a prior self-reported diagnostic mammogram had higher odds of false-positive results than those without a prior self-reported diagnostic mammogram. This study establishes contemporary evidence regarding prevalence and correlates of false-positive results after 3-D mammography in the unique BSPAN population, and demonstrate that use of 3-D mammography is not enough to reduce false-positive rates among uninsured women served through community outreach programs. Further research is needed to explore improved techniques to reduce false-positive rates, and ensure optimal use of scarce resources in outreach programs.

Cost Effectiveness of Mailed Outreach Programs for Colorectal Cancer Screening: Analysis of a Pragmatic, Randomized Trial.

BACKGROUND & AIMS: Clinical guidelines for colorectal cancer (CRC) screening suggest use of either stool-based tests or colonoscopy - modalities that differ in recommended screening intervals, adherence, and costs. We know little about the long-term cost differences in population-health outreach strategies to promote these strategies. METHODS: We conducted a cost-effectiveness analysis to compare 2 mailed outreach strategies to increase CRC screening from a pragmatic, randomized clinical trial: mailed fecal immunochemical test (FIT) kits vs invitations to complete a screening colonoscopy. We built a 10-year Markov chain Monte Carlo microsimulation model to account for differences in screening intervals, adherence, and costs. RESULTS: Mailed FIT kits had a lower 10-year average per-person cost of screening relative to colonoscopy invitations ($1139 vs $1725) but with 10.89 fewer months of compliance and 60 fewer advanced neoplasia detected (37 advanced adenomas and 23 CRC). Incremental cost effectiveness ratios for colonoscopy invitations compared with mailed FIT kits were $55.23, $15.84, and $25.48 per additional covered month, advanced adenoma, and CRC, respectively. Although FIT was the preferred strategy at low willingness-to-pay thresholds, the 2 strategies were equal at a willingness-to-pay threshold of $41.31 per covered month gained. CONCLUSION: Mailed FIT or colonoscopy invitations are both options to improve CRC screening completion and advanced neoplasia detection, and the choice of outreach strategy may differ by a health system's willingness-to-pay threshold. Mailed FIT kits are less expensive than colonoscopy invitations but result in fewer months of screening compliance and advanced neoplasia detected.

Long-term Mammography Adherence among Uninsured Women Enrolled in the Breast Screening and Patient Navigation (BSPAN) Program.

BACKGROUND: The Breast Screening and Patient Navigation (BSPAN) Program provides access to no-cost breast cancer screening services to uninsured women in North Texas. Using data from the longitudinal BSPAN program (2012-2019), we assessed prevalence and correlates of (i) baseline adherence and (ii) longitudinal adherence to screening mammograms. METHODS: Outcomes were baseline adherence (adherent if women received second mammogram 9-30 months after the index mammogram) and longitudinal adherence (assessed among baseline adherent women and defined as being adherent 39 months from the index mammogram). We used multivariable logistic regression and multivariable Cox proportional hazards model to assess associations of sociodemographic and clinical characteristics with baseline and longitudinal adherence, respectively. RESULTS: Of 19,292 women, only 5,382 (27.9%) were baseline adherent. Baseline adherence was more likely among women who were partnered, preferred speaking Spanish, had poor reading ability, had prior Papanicolaou (PAP) testing, and prior screening mammograms, compared with women who were non-partnered, preferred speaking English, had good reading ability, had no prior PAP testing, and no prior screening mammograms, respectively. Of those who were baseline adherent, 4,364 (81.1%) women demonstrated longitudinal adherence. Correlates of longitudinal adherence were similar to those from baseline adherence. CONCLUSIONS: A large proportion of baseline adherent women (>80%) achieved longitudinal adherence, which highlights the importance of concentrating resources during the second mammogram in the progression toward continued adherence. IMPACT: Results from our unique dataset provide realistic mammography adherence rates and may be generalizable to other areas introducing no-cost screening to low-income women, independent of any regular patient-centered medical home.

Longitudinal Experience With and Impressions of COVID-19-Related Clinical Research Changes.

PURPOSE: The COVID-19 pandemic has led to profound changes in clinical research, including remote consent, telehealth, off-site procedures, shipment of therapy, and remote study monitoring. We assessed longitudinal perceptions of these adjustments among clinical research professionals. METHODS: We distributed an anonymous survey assessing experiences, perceptions, and recommendations regarding COVID-19-related clinical research adjustments to cancer clinical research office personnel in May 2020 and again in November 2020. Responses were compared using Fisher's exact and Mann-Whitney U tests. RESULTS: A total of 90 of 102 invited research personnel (88%) responded. Fifty-three (59%) reported participating in both initial and follow-up surveys. The proportion of respondents reporting personal experience with COVID-19-related adjustments increased over time, particularly for remote initial consent (29% v 4%), remote reconsent (24% v 9%), and remote study monitoring (36% v 22%). Perceived impact of COVID-19-related adjustments on data quality (P = .02) and patient experience (P = .002) improved significantly. However, perceived effect on patient safety (P = .02) and respondent's experience (P = .09) became less favorable. Individuals with personal experience with the adjustment were more likely to recommend continuing remote consent (62% v 38%; P = .04), remote monitoring (69% v 45%; P = .05), and therapy shipment (67% v 35%; P = .01) after the COVID-19 pandemic, with nonsignificant trends for off-site diagnostics (44% v 24%; P = .13) and telehealth visits (66% v 45%; P = .08). CONCLUSION: More than 6 months into the global pandemic, perceptions of COVID-19-related clinical research changes remain favorable. Experienced individuals are more likely to recommend that these changes continue in the future.

De-implementation of cervical cancer screening before age 21.

In 2012, United States consensus guidelines were modified to recommend that cervical cancer screening not begin before age 21 and, since 2014, the Health Effectiveness Data and Information Set (HEDIS), a health plan quality measurement too, has included a measure for non-recommended cervical cancer screening among females ages 16-20. Our goal was to describe prevalence over time of cervical cancer screening before age 21 following the 2012 guideline change, and provide information to help understand how rapidly new guidelines may be disseminated and implemented into clinical practice. We used longitudinal clinical and administrative data from three diverse healthcare systems in the Population-based Research to Optimize the Screening Process (PROSPR II) consortium to examine annual trends in screening before age 21. We identified 55,316 average-risk, screening-eligible females ages 18-20 between 2011 and 2017. For each calendar year, we estimated the proportion of females who received a Papanicolaou (Pap) test. We observed a steady decline in the proportion of females under age 21 who received a Pap test, from an average of 8.3% in 2011 to <1% in 2017 across the sites. The observed steady decline suggests growing adherence to the 2012 consensus guidelines. This trend was consistent across diverse geographic regions, healthcare systems, and patient populations, strengthening the generalizability of the results; however, since we only had 1-2 years of study data prior to the consensus guidelines, we cannot discern whether screening under age 21 was already in decline. Nonetheless, these results provide data to compare with other guideline changes to de-implement non-recommended screening practices.

Patient, provider, and clinic factors associated with the use of cervical cancer screening.

Cervical cancer screening delivery remains suboptimal. Understanding the multiple influences on use of screening is important to designing interventions. We describe the influence of patient, primary care provider (PCP), and clinic characteristics on whether a woman is up-to-date with cervical screening as of December 2016. PCPs (n = 194) and their female screen-eligible patients age 21-65 years (n = 32,115) were included in this cross-sectional analysis of patients from two primary care networks linked to a contemporaneous PCP survey. Principal independent variables for patients included: age, race, insurance, continuity of care; for PCP included: overall satisfaction with the practice of medicine, gender, hours worked per week, financial support for achieving clinical targets; and for clinic included: routine receipt of data on preventive care performance and language translation resources. Overall, 66.6% of women were up-to-date. Women were less likely to be up-to-date with cervical cancer screening if they were younger and were more likely to be screened if they were Black, Hispanic or Asian vs. White. Women with greater continuity of primary care or with a female PCP were more likely to be up-to-date (1.52; 1.33-1.75); those who received care in a clinic that was less prepared to manage language translation were less likely to be up-to-date (0.78; 0.65-0.95). Patient, provider, and clinic factors all influence use of cervical cancer screening. Systems interventions like improving continuity of care, promoting translation services, or enhanced efforts to track screening among patients of male PCPs may improve delivery.

Racial and Ethnic Disparities in Access to Local Anesthesia for Inguinal Hernia Repair.

BACKGROUND: Many studies have identified racial disparities in healthcare, but few have described disparities in the use of anesthesia modalities. We examined racial disparities in the use of local versus general anesthesia for inguinal hernia repair. We hypothesized that African American and Hispanic patients would be less likely than Caucasians to receive local anesthesia for inguinal hernia repair. MATERIALS AND METHODS: We included 78,766 patients aged ≥ 18 years in the Veterans Affairs Surgical Quality Improvement Program database who underwent elective, unilateral, open inguinal hernia repair under general or local anesthesia from 1998-2018. We used multiple logistic regression to compare use of local versus general anesthesia and 30-day postoperative complications by race/ethnicity. RESULTS: In total, 17,892 (23%) patients received local anesthesia. Caucasian patients more frequently received local anesthesia (15,009; 24%), compared to African Americans (2353; 17%) and Hispanics (530; 19%), P < 0.05. After adjusting for covariates, we found that African Americans (OR 0.82, 95% CI 0.77-0.86) and Hispanics (OR 0.77, 95% CI 0.69-0.87) were significantly less likely to have hernia surgery under local anesthesia compared to Caucasians. Additionally, local anesthesia was associated with fewer postoperative complications for African American patients (OR 0.46, 95% CI 0.27-0.77). CONCLUSIONS: Although local anesthesia was associated with enhanced recovery for African American patients, they were less likely to have inguinal hernias repaired under local than Caucasians. Addressing this disparity requires a better understanding of how surgeons, anesthesiologists, and patient-related factors may affect the choice of anesthesia modality for hernia repair.

Local Anesthesia is Associated with Fewer Complications in Umbilical Hernia Repair in Frail Veterans.

BACKGROUND: The optimal anesthesia modality for umbilical hernia repair is unclear. We hypothesized that using local rather than general anesthesia would be associated with improved outcomes, especially for frail patients. METHODS: We utilized the 1998-2018 Veterans Affairs Surgical Quality Improvement Program to identify patients who underwent elective, open umbilical hernia repair under general or local anesthesia. We used the Risk Analysis Index to measure frailty. Outcomes included complications and operative time. RESULTS: There were 4958 Veterans (13%) whose hernias were repaired under local anesthesia. Compared to general anesthesia, local was associated with a 12%-24% faster operative time for all patients, and an 86% lower (OR 0.14, 95%CI 0.03-0.72) complication rate for frail patients. CONCLUSIONS: Local anesthesia may reduce the operative time for all patients and complications for frail patients having umbilical hernia repair.

Computer-tailored intervention increases colorectal cancer screening among low-income African Americans in primary care: Results of a randomized trial.

INTRODUCTION: Although African Americans have the highest colorectal cancer (CRC) incidence and mortality rates of any racial group, their screening rates remain low. STUDY DESIGN/PURPOSE: This randomized controlled trial compared efficacy of two clinic-based interventions for increasing CRC screening among African American primary care patients. METHODS: African American patients from 11 clinics who were not current with CRC screening were randomized to receive a computer-tailored intervention (n = 335) or a non-tailored brochure (n = 358) designed to promote adherence to CRC screening. Interventions were delivered in clinic immediately prior to a provider visit. Univariate and multivariable logistic regression models analyzed predictors of screening test completion. Moderators and mediators were determined using multivariable linear and logistic regression analyses. RESULTS: Significant effects of the computer-tailored intervention were observed for completion of a stool blood test (SBT) and completion of any CRC screening test (SBT or colonoscopy). The colonoscopy screening rate was higher among those receiving the computer-tailored intervention group compared to the nontailored brochure but the difference was not significant. Predictors of SBT completion were: receipt of the computer-tailored intervention; being seen at a Veterans Affairs Medical Center clinic; baseline stage of adoption; and reason for visit. Mediators of intervention effects were changes in perceived SBT barriers, changes in perceived colonoscopy benefits, changes in CRC knowledge, and patient-provider discussion. Moderators of intervention effects were age, employment, and family/friend recommendation of screening. CONCLUSION: This one-time computer-tailored intervention significantly improved CRC screening rates among low-income African American patients. This finding was largely driven by increasing SBT but the impact of the intervention on colonoscopy screening was strong. Implementation of a CRC screening quality improvement program in the VA site that included provision of stool blood test kits and follow-up likely contributed to the strong intervention effect observed at that site. The trial is registered at ClinicalTrials.gov as NCT00672828.

Using local rather than general anesthesia for inguinal hernia repair may significantly reduce complications for frail Veterans.

BACKGROUND: Frailty predisposes patients to poor postoperative outcomes. We evaluated whether using local rather than general anesthesia for hernia repair could mitigate effects of frailty. METHODS: We used the Risk Analysis Index (RAI) to identify 8,038 frail patients in the 1998-2018 Veterans Affairs Surgical Quality Improvement Program database who underwent elective, open unilateral inguinal hernia repair under local or general anesthesia. Our outcome of interest was the incidence of postoperative complications. RESULTS: In total, 5,188 (65%) patients received general anesthesia and 2,850 (35%) received local. Local anesthesia was associated with a 48% reduction in complications (OR 0.52, 95%CI 0.38-0.72). Among the frailest patients (RAI≥70), predicted probability of a postoperative complication ranged from 22 to 33% with general anesthesia, compared to 13-21% with local. CONCLUSIONS: Local anesthesia was associated with a ∼50% reduction in postoperative complications in frail Veterans. Given the paucity of interventions for frail patients, there is an urgent need for a randomized trial comparing effects of anesthesia modality on postoperative complications in this vulnerable population.

Using local rather than general anesthesia for inguinal hernia repair is associated with shorter operative time and enhanced postoperative recovery.

BACKGROUND: Inguinal hernia repair is the most common general surgery procedure and can be performed under local or general anesthesia. We hypothesized that using local rather than general anesthesia would improve outcomes, especially for older adults. METHODS: This is a retrospective review of 97,437 patients in the Veterans Affairs Surgical Quality Improvement Program who had open inguinal hernia surgery under local or general anesthesia. Outcomes included 30-day postoperative complications, operative time, and recovery time. RESULTS: Our cohort included 22,333 (23%) Veterans who received local and 75,104 (77%) who received general anesthesia. Mean age was 62 years. Local anesthesia was associated with a 37% decrease in the odds of postoperative complications (95% CI 0.54-0.73), a 13% decrease in operative time (95% CI 17.5-7.5), and a 27% shorter recovery room stay (95% CI 27.5-25.5), regardless of age. CONCLUSIONS: Using local rather than general anesthesia is associated with a profound decrease in complications (equivalent to "de-aging" patients by 30 years) and could significantly reduce costs for this common procedure.

Using Local Anesthesia for Inguinal Hernia Repair Reduces Complications in Older Patients.

BACKGROUND: Inguinal hernia repair is the most common general surgery operation in the United States. Nearly 80% of inguinal hernia operations are performed under general anesthesia versus 15%-20% using local anesthesia, despite the absence of evidence for the superiority of the former. Although patients aged 65 y and older are expected to benefit from avoiding general anesthesia, this presumed benefit has not been adequately studied. We hypothesized that the benefits of local over general anesthesia for inguinal hernia repair would increase with age. MATERIALS AND METHODS: We analyzed 87,794 patients in the American College of Surgeons National Surgical Quality Improvement Project who had elective inguinal hernia repair under local or general anesthesia from 2014 to 2018, and we used propensity scores to adjust for known confounding. We compared postoperative complications, 30-day readmissions, and operative time for patients aged <55 y, 55-64 y, 65-74 y, and ≥75 y. RESULTS: Using local rather than general anesthesia was associated with a 0.6% reduction in postoperative complications in patients aged 75+ y (95% CI -0.11 to -1.13) but not in younger patients. Local anesthesia was associated with faster operative time (2.5 min - 4.7 min) in patients <75 y but not in patients aged 75+ y. Readmissions did not differ by anesthesia modality in any age group. Projected national cost savings for greater use of local anesthesia ranged from $9 million to $45 million annually. CONCLUSIONS: Surgeons should strongly consider using local anesthesia for inguinal hernia repair in older patients and in younger patients because it is associated with significantly reduced complications and substantial cost savings.

Experience, Perceptions, and Recommendations Concerning COVID-19-Related Clinical Research Adjustments.

BACKGROUND: During the COVID-19 public health emergency, the FDA and NIH altered clinical trial requirements to protect participants and manage study conduct. Given their detailed knowledge of research protocols and regular contact with patients, clinicians, and sponsors, clinical research professionals offer important perspectives on these changes. METHODS: We developed and distributed an anonymous survey assessing COVID-19-related clinical trial adjustment experiences, perceptions, and recommendations to Clinical Research Office personnel at the Harold C. Simmons Comprehensive Cancer Center. Responses were compared using the Fisher exact test. RESULTS: A total of 94 of 109 contacted research personnel (87%) responded. Among these individuals, 58% had >5 years' professional experience in clinical research, and 56% had personal experience with a COVID-19-related change. Respondents perceived that these changes had a positive impact on patient safety; treatment efficacy; patient and staff experience; and communication with patients, investigators, and sponsors. More than 90% felt that positive changes should be continued after COVID-19. For remote consent, telehealth, therapy shipment, off-site diagnostics, and remote monitoring, individuals with personal experience with the specific change and individuals with >5 years' professional experience were numerically more likely to recommend continuing the adjustment, and these differences were significant for telehealth (P=.04) and therapy shipment (P=.02). CONCLUSIONS: Clinical research professionals perceive that COVID-19-related clinical trial adjustments positively impact multiple aspects of study conduct. Those with greatest experience-both specific to COVID-19-related changes and more generally-are more likely to recommend that these adjustments continue in the future.

Primary Care Provider Beliefs and Recommendations About Colorectal Cancer Screening in Four Healthcare Systems.

Primary care provider's (PCP) perceptions of colorectal cancer screening test effectiveness and their recommendations for testing intervals influence patient screening uptake. Few large studies have examined providers' perceptions and recommendations, including their alignment with evidence suggesting comparable test effectiveness and guideline recommendations for screening frequency. Providers (n = 1,281) within four healthcare systems completed a survey in 2017-2018 regarding their perceptions of test effectiveness and recommended intervals for colonoscopy and fecal immunochemical testing (FIT) for patients ages 40-49, 50-74, and ≥75 years. For patients 50-74 (screening eligible), 82.9% of providers rated colonoscopy as very effective versus 59.6% for FIT, and 26.3% rated colonoscopy as more effective than FIT. Also, for this age group, 77.9% recommended colonoscopy every 10 years and 92.4% recommended FIT annually. For patients ages 40-49 and ≥75, more than one-third of providers believed the tests were somewhat or very effective, although >80% did not routinely recommend screening by either test for these age groups. Provider screening test interval recommendations generally aligned with colorectal cancer guidelines; however, 25% of providers believed colonoscopy was more effective than FIT for mortality reduction, which differs from some modeling studies that suggest comparable effectiveness. The latter finding may have implications for health systems where FIT is the dominant screening strategy. Only one-third of providers reported believing these screening tests were effective in younger and older patients (i.e., <50 and ≥75 years). Evidence addressing these beliefs may be relevant if cancer screening recommendations are modified to include older and/or younger patients.

A randomized trial of mail and email recruitment strategies for a physician survey on clinical trial accrual.

BACKGROUND: Patient participation in cancer clinical trials is suboptimal. A challenge to capturing physicians' insights about trials has been low response to surveys. We conducted a study using varying combinations of mail and email to recruit a nationally representative sample of medical, surgical, and radiation oncologists to complete a survey on trial accrual. METHODS: We randomly assigned eligible physicians identified from the American Medical Association MasterFile (n = 13,251) to mail- or email-based recruitment strategies. Mail-based recruitment included a survey packet with: (1) cover letter describing the survey and inviting participation; (2) paper copy of the survey and postage-paid return envelope; and (3) a web link for completing the survey online. Email-based recruitment included an e-mail describing the survey and inviting participation, along with the web link to the survey, and a reminder postcard 2 weeks later. RESULTS: Response was higher for mail-based (11.8, 95% CI 11.0-12.6%) vs. email-based (4.5, 95% CI 4.0-5.0%) recruitment. In email-based recruitment, only one-quarter of recipients opened the email, and even fewer clicked on the link to complete the survey. Most physicians in mail-based recruitment responded after the first invitation (362 of 770 responders, 47.0%). A higher proportion of responders vs. non-responders were young (ages 25-44 years), men, and radiation or surgical (vs. medical) oncologists. CONCLUSIONS: Most physicians assigned to mail-based recruitment actually completed the survey online via the link provided in the cover letter, and those in email-based recruitment did not respond until they received a reminder postcard by mail. Providing the option to return a paper survey or complete it online may have further increased participation in the mail-based group, and future studies should examine how combinations of delivery mode and return options affect physicians' response to surveys.