Center Visits Research Articles

P187 Secukinumab significantly decreased joint synovitis measured by Power Doppler ultrasonography in biologic-naive patients with active psoriatic arthritis: primary (12week) results from a randomised, placebo-controlled Phase 3 study

P187 Secukinumab significantly decreased joint synovitis measured by Power Doppler ultrasonography in biologic-naive patients with active psoriatic arthritis: primary (12week) results from a randomised, placebo-controlled Phase 3 study

Prevalence of long-term opioid therapy in spine center outpatients the spinal pain opioid cohort (SPOC)

No reference material exists on the scope of long-term problems in novel spinal pain opioid users. In this study, we evaluate the prevalence and long-term use of prescribed opioids in patients of the Spinal Pain Opioid Cohort. The setting was an outpatient healthcare entity (Spine Center). Prospective variables include demographics, clinical data collected in SpineData, and The Danish National Prescription Registry. Patients with a new spinal pain episode lasting for more than two months, aged between 18 and 65years, who had their first outpatient visit. Based on the prescription of opioids from 4years before the first spine center visit to 5years after, six or more opioid prescriptions in a single 1-year interval fulfilled the main outcome criteria Long-Term Opioid Therapy (LTOT). Overall, of 8356 patients included in the cohort, 4409 (53%) had one or more opioid prescriptions in the registered nine years period. Of opioid users, 2261 (27%) were NaiveStarters receiving their first opioid prescription after a new acute pain episode; 2148(26%) PreStarters had previously received opioids. The prevalence of LTOT in PreStarters/NaiveStarters was 17.2%/11.2% in their first outpatient year. Similar differences between groups were seen in all follow-up intervals. In the last follow-up year, LTOT prevalence in Prestarters/NaiveStarters was 12.5%/7.0%. Previous opioid treatment-i.e., before a new acute spinal pain episode and referral to a Spine Center-doubled the risk of LTOT 5years later. The results underscore clinicians' obligation to carefully and individually weigh the benefits against the risks of prescribing opioid therapy. Diagnostic: individual cross-sectional studies with consistently applied reference standard and blinding.

Factors Affecting Anemia in Pregnant Women in Ratna Clinic

Anemia in the first trimester of pregnancy can cause abortion, missed abortion and congenital abnormalities, in the second trimester it causes premature labor, antepartum bleeding, impaired fetal growth in utero, asphyxia, LBW, low IQ and even infant death. the research objective was to determine the factors that influence anemia in pregnant women at Ratna Clinic.
 This research is an analytic survey with a cross sectional research design. The dependent variable used was the incidence of anemia and the independent variables were age, parity, ANC visit, knowledge and opinion. The population of this study were all pregnant women who were in the clinic ratna 123 people. The sample in this study amounted to 55 respondents. The sampling technique uses the Accidental Sampling technique.
 The results of the study on 55 respondents, most of whom did not experience anemia (normal) as many as 33 respondents (60%) and a small proportion had mild anemia as many as 6 respondents (10.9%).
 The conclusion from the research results is that there is no relationship between age, parity on anemia in pregnant women at the Kuta Baro Aceh Besar Community Health Center and ANC visits (p-value 0.002), knowledge (p-value 0.001) and income (0.009) on anemia in pregnant women at Ratna's Clinic. After conducting multivariate analysis, it was found that the ANC visit variable had the most influence on the incidence of anemia in pregnant women. The clinic leadership should make a policy and improve the quality of services for pregnant women by implementing and providing information to pregnant women about anemia prevention.

Community Mental Health Center Visits and Community Mobility of People with Serious Mental Illnesses: A Facilitator or Constraint?

Mental health services and interventions have increasingly focused on the importance of community participation and mobility for people with serious mental illnesses (SMI). This study examined the role that visits to community mental health centers (CMHCs) may play in increasing community mobility of people with SMI. Eighty-nine adults with SMI receiving services at three CMHCS were tracked with GPS-enabled phones over a 13-day period. Findings revealed that participants visited more destinations on days they went to a CMHC compared to days they did not. They also spent more time out of the home and traveled greater distances. Results suggest that the benefits of visiting a mental health center appear to go beyond treatment outcomes, but also point to the possibility that obligations, whether to a clinic appointment or possibly vocational, educational, leisure, faith, or social commitments, may be an important stepping stone to more mobility and intentional, sustained community participation.

POS-493 Predictors of Mortality in Chronic Hemodialysis Patients with COVID-19 at National Kidney and Transplant Institute: A Retrospective Cohort Study

COVID-19 has become a global health issue especially among chronic hemodialysis patients given their immunocompromised state, pre-existing co- morbidities and regular HD center visits. Thus, this study aims to determine the predictors of 30-day mortality among COVID-19 patients on hemodialysis. Methods. A retrospective cohort of adult chronic hemodialysis patients with COVID-19 from June 1 to August 30, 2020 in National Kidney Transplant Institute.

Urgent Care Centers Deter Some Emergency Department Visits But, On Net, Increase Spending.

There is substantial interest in using urgent care centers to decrease lower-acuity emergency department (ED) visits. Using 2008-19 insurance claims and enrollment data from a national managed care plan, we examined the association within ZIP codes between changes in rates of urgent care center visits and rates of lower-acuity ED visits. We found that although the entry of urgent care deterred lower-acuity ED visits, the impact was small. We estimate that thirty-seven additional urgent care center visits were associated with a reduction of a single lower-acuity ED visit. In addition, each $1,646 lower-acuity ED visit prevented was offset by a $6,327 increase in urgent care center costs. Therefore, despite a tenfold higher price per visit for EDs compared with urgent care centers, use of the centers increased net overall spending on lower-acuity care at EDs and urgent care centers.

Abstract S11-02: Factors associated with developing COVID-19 among cancer patients in New York City

Abstract Importance: Given concerns that cancer patients may be at increased risk of COVID-19 and may have more severe complications if infected, there have been profound changes to routine cancer care. We aimed to identify risk factors for developing COVID-19 among cancer patients. Methods: We conducted a retrospective cohort study of cancer patients tested for SARS-CoV-2 infection between March 1, 2020 and June 6, 2020 at NewYork-Presbyterian Hospital (NYPH)/Columbia University Irving Medical Center (CUIMC) in New York City. During this time period, all hospitalized patients (starting April 4, 2020) and all symptomatic cancer patients seen in the outpatient clinics were tested for COVID-19. Our primary outcome of interest was COVID-19 test results, defined as positive (SARS-CoV-2 detected on at least one test) or negative (not detected on any COVID-19 tests). Clinical data extraction included: age, sex, race/ethnicity (non-Hispanic white, non-Hispanic black, Hispanic, Asian, other, unknown), body mass index (BMI), smoking status, time since cancer diagnosis, cancer type, current cancer status, most recent cancer treatment type within the past year, time since last cancer treatment prior to COVID-19 testing, and infusion center visit within the past year. Chi-squared tests and multivariable logistic regression were used to examine the association between demographic, clinical, tumor and treatment-related factors and COVID-19 test results while controlling for covariates. Results: A total of 1,174 cancer patients were tested for COVID-19 with 317 (27%) patients testing positive. Demographic characteristics of the study population included a median age of 67 years (range, 1-103), 55.1% female, and 35.7% non-Hispanic white, 32.5% Hispanic, 15.2% non-Hispanic black, and 4.0% Asian. About 27.2% had a recent cancer diagnosis, 56.7% had active disease, and 56.7% were on active cancer treatment within the past year. In multivariable analysis, older age and higher BMI were associated with COVID-19. Compared to non-Hispanic whites, black and Hispanic cancer patients were more likely to test positive for COVID-19 (odds ratio [OR]=2.21, 95% confidence interval [CI]=1.44-3.40 and OR=2.71, 95% CI=1.91-3.83, respectively). A recent cancer diagnosis, active disease, and active cancer treatment were not associated with COVID-19. Compared to cancer patients not on active treatment, those receiving chemotherapy were less likely to develop COVID-19 (OR=0.65, 95% CI=0.44-0.95). We observed excess deaths among cancer patients who tested positive vs. negative for COVID-19 (28.4% vs. 8.3%, p<0.001). Conclusions and Relevance: Consistent with the general population, we found that older age, minority race/ethnicity, and obesity were associated with COVID-19 among cancer patients. Surprisingly, patients on active treatment including chemotherapy were not at increased risk for COVID-19. Therefore, delays in cancer diagnosis and treatment during the COVID-19 pandemic should be minimized. Citation Format: Monica F. Chen, Monica T. Coronel, Samuel Pan, Arreum Kim, Jessica Hawley, Gary Schwartz, Katherine Crew. Factors associated with developing COVID-19 among cancer patients in New York City [abstract]. In: Proceedings of the AACR Virtual Meeting: COVID-19 and Cancer; 2021 Feb 3-5. Philadelphia (PA): AACR; Clin Cancer Res 2021;27(6_Suppl):Abstract nr S11-02.

A community-based nurse-led medication self-management intervention in the improvement of medication adherence in older patients with multimorbidity: protocol for a randomised controlled trial

BackgroundOlder patients suffering from multimorbidity are at high risk of medication nonadherence. It has been well established that self-management support is an effective strategy to enhance medication adherence for patients with chronic conditions. However, little is known about the effect of the medication self-management intervention in older patients with multimorbidity. This paper presents the protocol for a study that aims to evaluate the effectiveness of a nurse-led medication self-management intervention in improving medication adherence and health outcomes for community-dwelling older patients with multimorbidity.MethodsThe study protocol follows the recommendations of the Standard Protocol Items: Recommendations for Interventional Trials 2013 statement. This study is a multicentre, single-blind, two-arm randomised controlled trial. Older patients with multimorbidity will be recruited from three community health centres in Changsha, China. A total of 136 participants will be randomly allocated to receive usual care or usual care plus the medication self-management intervention. The intervention will be delivered by community nurses. The 6-week intervention includes three face-to-face education sessions and two weekly follow-up phone calls. Participants in the control group continue to receive all respects of usual care offered by community healthcare providers, including chronic disease management, drug prescription, referral to hospital specialists, health education and consultations regarding patients’ diseases and treatments during centre visits. The primary outcome is medication adherence as measured by the 5-item Medication Adherence Report Scale. Secondary outcomes include medication self-management capacity (medication knowledge, medication beliefs, medication social support, medication skills, and medication self-efficacy), treatment experiences (medication treatment satisfaction and treatment burden), quality of life, and utilisation of healthcare services. All outcomes will be measured at baseline, immediately post-intervention, and at 3-month post-intervention.DiscussionThis study will provide evidence about the effectiveness of a medication self-management intervention, delivered by nurses, for older patients with multimorbidity and adherence problems. It is expected that the results of the study, if proven effective in improving patients’ adherence and health outcomes, will provide evidence-based self-management support strategies for healthcare providers in routine chronic disease management in community settings.Trial registrationThe trial is registered at ChiCTR.org.cn (ChiCTR2000030011; date February 19, 2020).

Health literacy level in rural Bayelsa, Nigeria’s Niger Delta Region

Background: Health literacy data is critical for enhancing self-care abilities and improving healthcare outcomes. However, information on health literacy level in rural Bayelsa, Nigeria’s Niger Delta region, is dearth. Objective of the study was to determine health literacy level of rural dwellers utilizing the services of Primary Healthcare Centers in rural Bayelsa.Methods: A total of 800 participants were randomly selected through multistage sampling procedure in a cross-sectional survey. Demographic data assessment questionnaire and the Brief Health Literacy Screening Tool were used for data collection. Descriptive statistics was done to obtain summaries of demographic and health literacy data while independent samples t-test, and one-way between group analysis of covariance was conducted to determine area-based differences in health literacy scores and the impact of frequency of health center visit on participants’ health literacy scores, respectively.Results: Health literacy assessment showed that, 570 (71.25%) participants had limited health literacy; 142 (17.75%) had marginal health literacy, and 88 (11.00%) had adequate health literacy. Health literacy scores were significantly higher in the upland (M=22.08, SD=8.64), than riverine areas of rural Bayelsa (M=18.66, SD=8.46; t (800)=8.02, p=0.00, 2-tailed). Frequency of health center visit significantly accounted for 20% of the variance in participants’ health literacy scores (F (2, 796) = 95.72, p=0.00, eta squared=0.20)).Conclusions: Health literacy level is low, and indicates a public health emergency. Rural educational development and modification of rural healthcare communication pattern may reduce health illiteracy and its attendant effect.

Traffic-related air pollution is associated with glucose dysregulation, blood pressure, and oxidative stress in children

BackgroundMetabolic syndrome increases the risk of cardiovascular disease in adults. Antecedents likely begin in childhood and whether childhood exposure to air pollution plays a contributory role is not well understood. ObjectivesTo assess whether children's exposure to air pollution is associated with markers of risk for metabolic syndrome and oxidative stress, a hypothesized mediator of air pollution-related health effects. MethodsWe studied 299 children (ages 6–8) living in the Fresno, CA area. At a study center visit, questionnaire and biomarker data were collected. Outcomes included hemoglobin A1c (HbA1c), urinary 8-isoprostane, systolic blood pressure (SBP), and BMI. Individual-level exposure estimates for a set of four pollutants that are constituents of traffic-related air pollution (TRAP) – the sum of 4-, 5-, and 6-ring polycyclic aromatic hydrocarbon compounds (PAH456), NO2, elemental carbon, and fine particulate matter (PM2.5) – were modeled at the primary residential location for 1-day lag, and 1-week, 1-month, 3-month, 6-month, and 1-year averages prior to each participant's visit date. Generalized additive models were used to estimate associations between each air pollutant exposure and outcome. ResultsThe study population was 53% male, 80% Latinx, 11% Black and largely low-income (6% were White and 3% were Asian/Pacific Islander). HbA1c percentage was associated with longer-term increases in TRAP; for example a 4.42 ng/m3 increase in 6-month average PAH456 was associated with a 0.07% increase (95% CI: 0.01, 0.14) and a 3.62 μg/m3 increase in 6-month average PM2.5 was associated with a 0.06% increase (95% CI: 0.01, 0.10). The influence of air pollutants on blood pressure was strongest at 3 months; for example, a 6.2 ppb increase in 3-month average NO2 was associated with a 9.4 mmHg increase in SBP (95% CI: 2.8, 15.9). TRAP concentrations were not significantly associated with anthropometric or adipokine measures. Short-term TRAP exposure averages were significantly associated with creatinine-adjusted urinary 8-isoprostane. DiscussionOur results suggest that both short- and longer-term estimated individual-level outdoor residential exposures to several traffic-related air pollutants, including ambient PAHs, are associated with biomarkers of risk for metabolic syndrome and oxidative stress in children.

Medicare/Medicaid Insurance, Rurality, and Black Race Associated With Provision of Hepatocellular Carcinoma Treatment and Survival.

Early treatment of hepatocellular carcinoma (HCC) is associated with improved survival, but many patients with HCC do not receive therapy. We aimed to examine factors associated with HCC treatment and survival among incident patients with HCC in a statewide cancer registry. All patients with HCC from 2003 through 2013 were identified in the North Carolina cancer registry. These patients were linked to insurance claims from Medicare, Medicaid, and large private insurers in North Carolina. Associations between prespecified covariates and more advanced HCC stage at diagnosis (ie, multifocal cancer), care at a liver transplant center, and provision of HCC treatment were examined using multivariate logistic regression. A Cox proportional hazards model was developed to assess the association between these factors and survival. Of 1,809 patients with HCC, 53% were seen at a transplant center <90 days from diagnosis, with lower odds among those who were Black (adjusted odds ratio [aOR], 0.54; 95% CI, 0.39-0.74), had Medicare insurance (aOR, 0.35; 95% CI, 0.21-0.59), had Medicaid insurance (aOR, 0.46; 95% CI, 0.28-0.77), and lived in a rural area; odds of transplant center visits were higher among those who had prediagnosis alpha fetoprotein screening (aOR, 1.74; 95% CI, 1.35-2.23) and PCP and gastroenterology care (aOR, 1.66; 95% CI, 1.27-2.18). Treatment was more likely among patients who had prediagnosis gastroenterology care (aOR, 1.68; 95% CI, 0.98-2.86) and transplant center visits (aOR, 2.42; 95% CI, 1.74-3.36). Survival was strongly associated with age, cancer stage, cirrhosis complications, and receipt of HCC treatment. Individuals with Medicare (adjusted hazard ratio [aHR], 1.58; 95% CI, 1.20-2.09) and Medicaid insurance (aHR, 1.55; 95% CI, 1.17-2.05) had shorter survival than those with private insurance. In this population-based cohort of patients with HCC, Medicare/Medicaid insurance, rural residence, and Black race were associated with lower provision of HCC treatment and poorer survival. Efforts should be made to improve access to care for these vulnerable populations.

Do low-cost economic incentives motivate healthy behavior?

We conducted a field experiment to test the effectiveness of a conditional, low-cost, and recurring financial incentive in motivating recreation center visits. Results indicate that the financial incentive did not motivate students’ recreation center visits. However, it was successful in increasing the frequency of recreation center visits for female students who had an established exercise habit. For a payout of $0.50, we estimate an increase of 0.4 visits per week for female students with established exercise habits. This provides modest evidence that the financial incentive structure was able to increase the behavioral response at the intensive margin. Our results show that the design of our financial incentive was not effective on the extensive margin. There was also no effect of the financial incentive on the recreation center visits for male students.

Adherence to prenatal iron-folic acid supplementation and associated factors among pregnant women attending antenatal care services in Dilla town, South Ethiopia.

Background:During pregnancy, due to the physiological and hormonal change, the requirement of iron–folic acid is enhanced. Therefore, the occurrence of iron/folic acid deficiency is relatively high and it is responsible for 95% of anemia during pregnancy.Objectives:The aim of this study was to assess adherence to prenatal iron–folic acid supplementation (IFAS) and associated factors among pregnant women attending antenatal care services at public health facilities of Dilla town.Methods:Facility-based cross-sectional study design was employed selecting 403 pregnant women attending antenatal care services in three public health institutions of Dilla town. The women were included in the study by simple random sampling. Data were collected by interview and document review. Then it was entered into EPI Data version 3.1 and exported to SPSS version 20 for analysis. Bivariate and multivariate binary logistic regression techniques were used to identify independent predictors. A p-value <0.05 was taken as indication of statistical significance.Results:From the total of planned 403 pregnant women, 396 participated in the study, with a response rate of 98.2%. Of these, 172 (43.4%) pregnant women were adhered to IFAS. The study also revealed that history of previous anemia (adjusted odds ratio (AOR) = 1.87; 95% confidence interval (CI): (1.01–3.47); p = 0.04), frequency of antenatal care center (ANC) visits (AOR = 2.51; 95% CI: (1.17–5.37); p = 0.01), knowledge of IFA supplement (AOR = 2.28; 95% CI: (1.36–3.82); p = 0.002), and knowledge of anemia (AOR = 2.30; 95% CI: (1.40–3.77); p = 0.001) were independent predictors of adherence to IFAS.Conclusion:The finding of this study showed that less than half of the pregnant women were adhered to IFAS. History of previous anemia, frequency of ANC visits, knowledge of IFA supplement, and knowledge of anemia were the factors associated with adherence to IFA supplement.

Effects of Covid-19 on walk-in and after hours ophthalmology presentations at a tertiary academic eye center

Purpose: The novel coronavirus 2019 (Covid-19) has resulted in millions of acute infections and widespread lockdowns. Non-emergent medical care and elective surgical procedures experienced a sharp downturn as a result. The primary aim of this study was to determine the effect of the pandemic lockdown on the volume of ophthalmologic visits at a tertiary care center. Methods: Retrospective review of 3647 patient encounters was conducted for periods February 15thJuly 31st during the years 2018, 2019, and 2020. Three sub-cohorts of data were analyzed: emergency room consultations, after-hours on-call visits, and daytime visits at a walk-in triage clinic. Encounters were subdivided into pre-lockdown, lockdown, and post-lockdown time periods. Group comparisons were performed with Poisson probability testing. Results: A total of 1322, 1349, and 976 ophthalmology visits were recorded from February 15th to July 31st for years 2018, 2019, and 2020, respectively. Total visits in 2020 were reduced by 27% when compared to the mean visits for 2018 and 2019, most notably in April (41%), March (34%), May (32%), and June (86%) [p<0.001]. The reduction in 2020 after-hours visits (96%, p<0.001) was significantly greater than that of emergency room consultations (9.4%, p=0.10) and triage center visits (7.7%, p<0.02). Conclusion: A substantial decrease in ophthalmic care was observed during both the 2020 pandemic lockdown, and while restrictions were eased. After-hours visits were more significantly impacted when compared to other clinical settings. The importance of maintaining ophthalmology walk-in clinics, telemedicine, and increasing patient education are key to optimizing eye health during a global pandemic.

Factors Influencing Visitor Center Visits by Jodogahama Beach Visitors and the Functions They Want

Factors Influencing Visitor Center Visits by Jodogahama Beach Visitors and the Functions They Want

625. Sustained Efforts Improve Adherence to Monitoring for Solid Tumor Patients Discharged on Outpatient Parenteral Antimicrobial Therapy (OPAT) at a Comprehensive Cancer Center

BackgroundOPAT helps reduce hospital length of stay, but 1 in 4 patients is readmitted within 30 days of discharge. Follow up < 30 days after discharge and laboratory monitoring during therapy have been shown to reduce hospital readmissions. However, few OPAT studies have included patients with malignancies, who may not experience the same benefits due to increased risks for hospital admission and infection related to antineoplastic therapy. We started an OPAT program to increase laboratory monitoring and clinic follow up among patients with solid tumors, attempting to also decrease readmissions.MethodsWe obtained demographic data and baseline frequencies of laboratory monitoring, ID clinic follow up, 30-day OPAT-related readmissions, Emergency Center (EC) visits, and deaths by retrospective chart review. We conducted multiple interventions from June 2018-January 2020: clarifying physician recommendations for laboratory monitoring and follow up by using a standardized electronic medical record template, communicating recommendations to case management, and changing the lab ordering workflow. We compared frequencies after interventions to baseline by using Fisher’s exact test.ResultsMost commonly observed malignancies in our patient cohort included genitourinary, breast, gastrointestinal, gynecologic, and head and neck. The most commonly treated infections included abscess, bacteremia, and skin and soft tissue. The percentage of patients without recommended lab monitoring decreased from 32.3% to 15.3% (p=0.03). We observed trends toward improved ID clinic follow up (54.8% to 71.8%; p=0.12) and decreased 30-day OPAT-related readmissions from 16.7% to 8.6% (p = 0.17). We observed no difference in mortality or EC visits.ConclusionOPAT-treated infections in our solid tumor patient cohort differed from those reported commonly. Through continued interventions, we improved lab monitoring rates among solid tumor patients with trends toward improved ID clinic follow up and decreased readmission rates. Our findings suggest that despite competing reasons for hospital readmission, OPAT may still benefit this population.Disclosures All Authors: No reported disclosures

Peer recovery coaches in general medical settings: Changes in utilization, treatment engagement, and opioid use

Recovery coaches, trained peers with a history of substance use disorder (SUD) who are formally embedded in the health care team, may be a cost-effective approach to support outpatient management of SUD treatment. Although recovery coach programs are scaling nationwide, limited data exist to support their impact on costs or clinical outcomes. This study aimed to evaluate the integration of peer recovery coaches in general medical settings. Staff hired and trained nine recovery coaches as a part of a health system–wide effort to redesign SUD care. We examined reductions in acute care utilization and increases in outpatient treatment utilization among patients connected to a recovery coach. Additionally, we examined buprenorphine treatment engagement and opioid abstinence among a subset of patients who initiated buprenorphine prior to or within 30 days of their first recovery coach contact. We hypothesized recovery coach contact would strengthen outpatient SUD treatment and be associated with reductions in SUD severity and preventable acute care utilization. We included patients with an initial recovery coach contact between January 2015 and September 2017 in the main analyses (N = 1171). We assessed utilization outcomes via medical records over one year, comparing the six months before and after first recovery coach contact. We used chart review to extract toxicology results and buprenorphine treatment engagement for the subset of patients initiated on buprenorphine (n = 135). In the six months following recovery coach contact, there was a 44% decrease in patients hospitalized and a 9% decrease in patients with an ED visit. There was a 66% increase in outpatient utilization across primary care, community health center visits, mental health, and laboratory visits. Among patients who initiated buprenorphine, current recovery coach contact was associated with significantly increased odds of buprenorphine treatment engagement (OR = 1.89; 95% CI: 1.49–2.39; p < 0.001) and opioid abstinence (OR = 1.32; 95% CI: 1.02–1.70; p < 0.001). Recovery coaches may be an impactful and potentially cost-effective addition to an SUD care team, but future research is needed that uses a matched comparison condition.

Association Between Preoperative Patient-Reported Symptoms and Postoperative Outcomes in Rectal Cancer Patients: A Retrospective Cohort Study

BackgroundRectal cancer patients undergoing preoperative radiotherapy experience a significant symptom burden. However, it is unknown whether symptoms during radiotherapy may portend adverse postoperative outcomes and healthcare utilization. MethodsA retrospective cohort study was performed of rectal cancer patients undergoing neoadjuvant radiotherapy and proctectomy in Ontario from 2007 to 2014. The primary outcome was a complicated postoperative course–a dichotomous variable created as a composite of postoperative mortality, major morbidity, or hospital readmission. Patient-reported Edmonton Symptom Assessment System (ESAS) scores, collected routinely at outpatient provincial cancer center visits, were linked to administrative healthcare databases. The receiver-operating characteristic analysis was used to compare ESAS scoring approaches and to stratify patients into low versus high symptom score groups. Multivariable regression models were constructed to evaluate associations between preoperative symptom scores and postoperative outcomes. Results1455 rectal cancer patients underwent sequential radiotherapy and proctectomy during the study period and recorded symptom assessments. Patients with high preoperative symptom scores were significantly more likely to experience a complicated postoperative course (OR 1.55, 95% CI 1.23-1.95). High preoperative ESAS scores were also associated with the secondary outcomes of emergency department visits (OR 1.34, 95% CI 1.08-1.66) and longer length of stay (IRR 1.23, 95% CI 1.04-1.45). ConclusionsRectal cancer patients reporting elevated symptom scores during neoadjuvant radiotherapy have increased odds of experiencing a complicated postoperative course. Preoperative patient-reported outcome screening may be a useful tool to identify at-risk patients and to efficiently direct perioperative supportive care.

Assessing the potential for prevention or earlier detection of on-site monitoring findings from randomised controlled trials: Further analyses of findings from the prospective TEMPER triggered monitoring study.

Background/Aims:Clinical trials should be designed and managed to minimise important errors with potential to compromise patient safety or data integrity, employ monitoring practices that detect and correct important errors quickly, and take robust action to prevent repetition. Regulators highlight the use of risk-based monitoring, making greater use of centralised monitoring and reducing reliance on centre visits. The TEMPER study was a prospective evaluation of triggered monitoring (a risk-based monitoring method), whereby centres are prioritised for visits based on central monitoring results. Conducted in three UK-based randomised cancer treatment trials of investigational medicine products with time-to-event outcomes, it found high levels of serious findings at triggered centre visits but also at visits to matched control centres that, based on central monitoring, were not of concern. Here, we report a detailed review of the serious findings from TEMPER centre visits. We sought to identify feasible, centralised processes which might detect or prevent these findings without a centre visit.Methods:The primary outcome of this study was the proportion of all ‘major’ and ‘critical’ TEMPER centre visit findings theoretically detectable or preventable through a feasible, centralised process. To devise processes, we considered a representative example of each finding type through an internal consensus exercise. This involved (a) agreeing the potential, by some described process, for each finding type to be centrally detected or prevented and (b) agreeing a proposed feasibility score for each proposed process. To further assess feasibility, we ran a consultation exercise, whereby the proposed processes were reviewed and rated for feasibility by invited external trialists.Results:In TEMPER, 312 major or critical findings were identified at 94 visits. These findings comprised 120 distinct issues, for which we proposed 56 different centralised processes. Following independent review of the feasibility of the proposed processes by 87 consultation respondents across eight different trial stakeholder groups, we conclude that 306/312 (98%) findings could theoretically be prevented or identified centrally. Of the processes deemed feasible, those relating to informed consent could have the most impact. Of processes not currently deemed feasible, those involving use of electronic health records are among those with the largest potential benefit.Conclusions:This work presents a best-case scenario, where a large majority of monitoring findings were deemed theoretically preventable or detectable by central processes. Caveats include the cost of applying all necessary methods, and the resource implications of enhanced central monitoring for both centre and trials unit staff. Our results will inform future monitoring plans and emphasise the importance of continued critical review of monitoring processes and outcomes to ensure they remain appropriate.

Tutors’ and Multilingual Writers’ Narrative Framing of Writing Center Visits

This study explores how first-year multilingual writers in a classroom community make sense of their first university writing center visits. Employing narrative analysis of student journals, this study illustrates differences in themes writers discuss in their narratives of first writing center visits and themes in self-reflections on their writing. Comparing narratives in student journals and tutor report forms, this study also presents the congruities and discrepancies between writer and tutor views of a session. Writer emphasis on grammar when narrating writing center visits contrasts with writer emphasis on development in self-reflections on their writing. When tutor and writer session descriptions differ, tutors emphasize discussion of development and organization while writers emphasize sentence-level accuracy. Without scaffolding of strategies for writing center use, first-year multilingual writers may privilege sentence-level feedback in their early understanding of the writing center, resulting in a more limited experience of writing center support.