The Rethinking Clinical Trials (REaCT) Program. A Canadian-Led Pragmatic Trials Program: Strategies for Integrating Knowledge Users into Trial Design

We reviewed patient and health care provider (HCP) surveys performed through the REaCT program. The REaCT team has performed 15 patient surveys (2298 respondents) and 13 HCP surveys (1033 respondents) that have addressed a broad range of topics in breast cancer management. Over time, the proportion of surveys distributed by paper/regular mail has fallen, with electronic distribution now the norm. For the patient surveys, the median duration of the surveys was 3 months (IQR 2.5–7 months) and the median response rate was 84% (IQR 80–91.7%). For the HCP surveys, the median survey duration was 3 months (IQR 1.75–4 months), and the median response rate, where available, was 28% (IQR 21.2–49%). The survey data have so far led to: 10 systematic reviews, 6 peer-reviewed grant applications and 19 clinical trials. Knowledge users should be an essential component of clinical research. The REaCT program has integrated surveys as a standard step of their trials process. The COVID-19 pandemic and reduced face-to-face interactions with patients in the clinic as well as the continued importance of social media highlight the need for alternative means of distributing and responding to surveys.

Provider Perspectives on the Impact of the COVID-19 Pandemic on Newborn Screening

The onset of the COVID-19 pandemic caused significant changes in healthcare delivery. Telemedicine rapidly and unexpectedly became the primary vehicle for ambulatory management. As newborn screen (NBS) referrals require varying levels of acuity, whether telemedicine could be used as a safe and effective medium to return these results were unknown. We sent an online survey to metabolism providers internationally to investigate triage differences of abnormal NBS results during the COVID-19 pandemic. The survey compared personal practice for the periods of March–June 2019 and March–June 2020. Responses were received from 44 providers practicing in 8 countries. Nearly all (93%) practiced in areas of widespread SARS-COV-2 community transmission during spring 2020. There was a significant expansion of telemedicine use for NBS referrals at the onset of the COVID-19 pandemic (OR: 12, 95% CI: 3.66–39.3, p < 0.0001). Telehealth primarily replaced in-person ambulatory metabolism visits. The increased frequency of virtual care was similar across NBS analytes. Providers found telehealth for NBS referral equally efficacious to in-person care. Institutional patient surveys showed no difference in satisfaction with provider communication, provider empathy, or appointment logistics. Our survey was limited by unprecedented disruption in healthcare delivery, necessitating further validation of telegenetics for NBS in the post-pandemic era. Nevertheless, our findings demonstrate that telemedicine is potentially a viable and practical tool for triaging abnormal NBS results.

Clinical coding of long COVID in English primary care: a federated analysis of 58 million patient records in situ using OpenSAFELY

Background: Long COVID describes new or persistent symptoms at least four weeks after onset of acute COVID-19. Clinical codes to describe this were recently created. Aim: To describe the use of long COVID codes, and variation of use by general practice, demographics and over time. Design and Setting: Population-based cohort study in English primary care records. Method: Working on behalf of NHS England, we used OpenSAFELY data encompassing 96% of the English population between 2020-02-01 and 2021-04-25. We measured the proportion of people with a recorded code for long COVID, overall and by demographic factors, electronic health record software system (EMIS or TPP), and week. Results: Long COVID was recorded for 23,273 people. Coding was unevenly distributed amongst practices, with 26.7% of practices having never used the codes. Regional variation, ranged between 20.3 per 100,000 people for East of England (95% confidence interval 19.3-21.4) and 55.6 in London (95% CI 54.1-57.1). Coding was higher amongst women (52.1, 95% CI 51.3-52.9) than men (28.1, 95% CI 27.5-28.7), and higher amongst EMIS practices (53.7, 95% CI 52.9-54.4) than TPP practices (20.9, 95% CI 20.3-21.4). Conclusion: Long COVID coding in primary care is low compared with early reports of long COVID prevalence. This may reflect under-coding, sub-optimal communication of clinical terms, under-diagnosis, a true low prevalence of long COVID diagnosed by clinicians, or a combination of factors. We recommend increased awareness of diagnostic codes, to facilitate research and planning of services; and surveys of clinicians’ experiences, to complement ongoing patient surveys.

Impact of rapid infliximab infusions on access at a large academic tertiary medical center

Purpose Infliximab promotes remission in patients with inflammatory bowel disease (IBD) and rheumatologic disease (RD). Rapid infliximab infusions (RI) reduce infusion time from 2 hours to 1 hour and can enhance access to care, as defined by capacity, safety, and patient characteristics. Our hypothesis for the study described here was that use of RI can enhance access for patients. Methods Data on all patients receiving infliximab for IBD or RD at our outpatient infusion center from February 2016 to August 2017 were retrospectively analyzed. Demographic and clinical information were collected. Results Of 348 patients who received infliximab, 205 had IBD and 143 had RD. In terms of capacity, 40% of patients received RI, resulting in a 16.1% decrease in average daily infusion time and a 9.8% increase in average daily available scheduled infusion chair time (P = 0.720). In terms of safety, 4 patients switched back to standard infusions after RI, after 3 specifically had reactions to RI. In terms of patient characteristics, more patients with RD versus IBD received RI (P = 0.020). Among the patients with RD, a lower proportion receiving RI were female (P = 0.043). For the patients with IBD, a higher proportion receiving RI were white (P = 0.048). Among both patients with RD and patients with IBD, a higher proportion receiving RI had private insurance (P = 0.016 and P = 0.018, respectively). Conclusion RI were safe and increased available chair time. Females with RD, patients of non-White race with IBD, and patients with public insurance were less likely to receive RI. Future directions include patient surveys and evaluation of implicit bias against patient factors that may impact access to RI.

Clinical coding of long COVID in English primary care: a federated analysis of 58 million patient records in situ using OpenSAFELY

Background Long COVID is a term to describe new or persistent symptoms at least four weeks after onset of acute COVID-19. Clinical codes to describe this phenomenon were released in November 2020 in the UK, but it is not known how these codes have been used in practice. Methods Working on behalf of NHS England, we used OpenSAFELY data encompassing 96% of the English population. We measured the proportion of people with a recorded code for long COVID, overall and by demographic factors, electronic health record software system, and week. We also measured variation in recording amongst practices. Results Long COVID was recorded for 23,273 people. Coding was unevenly distributed amongst practices, with 26.7% of practices having not used the codes at all. Regional variation was high, ranging between 20.3 per 100,000 people for East of England (95% confidence interval 19.3-21.4) and 55.6 in London (95% CI 54.1-57.1). The rate was higher amongst women (52.1, 95% CI 51.3-52.9) compared to men (28.1, 95% CI 27.5-28.7), and higher amongst practices using EMIS software (53.7, 95% CI 52.9-54.4) compared to TPP software (20.9, 95% CI 20.3-21.4). Conclusions Long COVID coding in primary care is low compared with early reports of long COVID prevalence. This may reflect under-coding, sub-optimal communication of clinical terms, under-diagnosis, a true low prevalence of long COVID diagnosed by clinicians, or a combination of factors. We recommend increased awareness of diagnostic codes, to facilitate research and planning of services; and surveys of clinicians' experiences, to complement ongoing patient surveys.

AI based satisfaction survey of patients in fever clinics during the outbreak of COVID-19

Background: We assessed patient by automated survey method in understanding and satisfaction with the use of fever clinic, and observed the effectiveness of this method. Methods: Total 873 patients in fever clinc at Jiangsu Province Hospital (JSPH) from 20 January 2019 to 18 June 2020 were investigated by an antomated survey method conbined by Wechat, Short Message Service (SMS) and AI voice call. Responses were assessed for overall positivity or negativity and further compared according to patients types (isolated patients and non-isolated patients). Responses were also described and compared for each type of survey. Results: A total of 379 patient surveys were returned, for a total response rate of 43.4%. Isolated and non-isolated patients responses were similar and all with more than 90% satisfaction. Most isolated patient represent that the medical staff had explained to them the reason for the isolation and know that can helps prevent COVID-19. AI voice calls had the highest percentage of all response types, followed by WeChat and SMS. Conclusion: The patient has a positive response to the use of fever clinic. The automated survey method combine by different survey types can bring great convenience to the investigation while ensuring good investigation efficiency.

405 The Effect of a Patient Survey in the Evaluation of Obstructive Sleep Apnea in a High Risk Cardiology Outpatient Population

Introduction Obstructive sleep apnea (OSA) is the most common sleep-related breathing disorder. The estimated prevalence is approximately 15 to 30 percent in males and 10 to 15 percent in females. Patients with OSA have an increased propensity for cardiovascular diseases and obesity. Observational studies have demonstrated a consistent association between OSA and hypertension, coronary artery disease, cardiac arrhythmias, and heart failure. The purpose of this study is to evaluate if a patient survey can improve the diagnosis of OSA in a high-risk outpatient cardiac clinic. Methods In an outpatient cardiac clinic, a retrospective analysis of OSA evaluations was done before and after the use of patient surveys in a high-risk population. The high-risk patient group was defined by the presence of two or more of the following conditions: hypertension, heart failure, cardiac arrhythmias, atrial fibrillation, obesity with a BMI of 30 or more, coronary artery disease, diabetes mellitus, chronic lung disease, history of cerebrovascular accident (CVA), hypothyroidism and chronic renal insufficiency. The patient survey included questions on the presence of daytime sleepiness, presence of snoring, ESS score, choking in sleep, witness apnea, and frequent waking in sleep. Results During the four months of patient survey use, a total of 143 patients were evaluated as compared to 86 patients in the prior four months without the use of the survey. A significant increase (66.3%) of OSA evaluations was observed during the patient survey period. Conclusion The use of patient surveys showed a significant improvement in OSA diagnoses in the defined high-risk patient group. Patient surveys might be beneficial to improve the under diagnosis of sleep apnea in high-risk patient populations. Additional research needs to be done to establish the impact of such intervention on patient outcomes. Support (if any):