Probability-of-decision interval 3+3 (POD-i3+3) design for phase I dose finding trials with late-onset toxicity

Late-onset toxicities often occur in phase I trials investigating novel immunotherapy and molecular targeted therapies. For trials with cohort based designs (such as modified toxicity probability interval, Bayesian optimal interval, and i3+3), patients are often turned away since the current cohort are still being followed without definite dose-limiting toxicities, which results in prolonged trial duration and waste of patient resources. In this paper, we incorporate a probability-of-decision framework into the i3+3 design and allow real-time dosing inference when the next patient becomes available. Both follow-up time for the pending patients and time to dose-limiting toxicities for the observed patients are used in calculating the posterior probability of each possible dosing decision. An intensive simulation study is conducted to evaluate the operating characteristics of the newly proposed probability-of-decision-i3+3 design under various dosing scenarios and patient accrual settings. Results show that the probability-of-decision-i3+3 design achieves comparable safety and reliability performances but much shorter trial duration compared to the complete designs.

An Evaluation Of The Quality Of Patient-Oriented Online Resources For Hemodialysis Access (Preprint)

BACKGROUND Patients and families increasingly turn to the internet for information and resources regarding their medical conditions. These searches are conducted in an independent and unsupervised manner, often without guidance from providers. Multiple reports in the medical oncology literature have cast significant doubt on the accuracy and currency of the data found on patient-focused websites OBJECTIVE To critically appraise the quality of patient-focused online resources concerning hemodialysis access procedures. METHODS A recently validated search strategy using the meta-search engines Google, Dogpile, and Yippy with the query “hemodialysis access” was performed on a cleared-cache web browser during January 2020. Inclusion criteria for the study were websites intended for patient education in English. Exclusions criteria consisted of online monographs, academic journals, and sites requiring paid subscription. Three independent reviewers evaluated the websites using a validated, structured rating tool that scored the Affiliation, Accountability, Interactivity, Structure and Organization, Readability, and Content of the websites. Inter-rater reliability was quantified by calculated kappa coefficients for each element of the instrument. RESULTS Out of more than 27 million collective search results using the three meta-search engines, the first 269 hits were considered for analysis. Only 63 unique patient-oriented sites were acceptable for analysis. 46% were sponsored by commercial entities. Accountability and interactivity were weak across sites. Readability as determined by Flesch-Kincaid and SMOG indices ranged from 6th grade to post-graduate level. 19% were written at a college reading level or higher, however these sites had content quality comparable to those utilizing more elementary prose. 85% of non-commercial domain sites were free of inaccuracies compared to 59% of commercial sites (P=.02). Non-commercial domain sites trended toward more comprehensive content as well as superior readability (average 10th grade reading level compared to average 11th grade reading level, P=.08). The average composite score of all the websites was 2.8 out of a maximum possible weighted score of 7.8, indicating poor global quality of websites. Kappa coefficients were 0.7 or greater for a random sample of 10 websites. CONCLUSIONS This is the first report on the quality of online patient resources in vascular surgery. The study demonstrates that online patient education resources regarding hemodialysis access are poor and require input from the vascular surgery community. Providers need to be aware and understand this issue and seek to inform and mitigate misinformation and potential misguidance. The vascular surgery community should invest in more readable and comprehensive web resources. CLINICALTRIAL n.a

1205. Vaccine Hesitancy in Paediatric Practice and Predictors of Physician-Reported Vaccine Compliance

Background This study explores the frequency with which Canadian paediatricians encounter vaccine hesitancy in their clinical practice, the most common approaches to parent resistance, impact of hesitancy practice and predictors of physician-reported vaccine compliance. Methods This analysis used data collected from Canadian paediatricians and paediatric subspecialists via a one-time survey distributed by the Canadian Paediatric Surveillance Program in the fall of 2015. Descriptive analyses were conducted to determine the frequency of hesitancy, approaches to parent resistance and impact on clinical practice. A classification tree was generated to determine the most important predictors of physician-reported vaccine compliance. Results A total of 669 paediatricians completed the survey. Eighty-nine percent (n=588) of respondents indicated they had encountered hesitancy in their practice, with the top concerns including: Autism, too many vaccines, risk of a weakened immune system, and vaccine additives. The most common responses to parent resistance included discussing risks of non-vaccination, restating the vaccine recommendation and referring to reliable patient resources. Forty-five percent (n=301) of physicians indicated that hesitancy impacted their practice. Overall, the best predictor of physician-reported vaccine compliance was the use of a personal endorsement or anecdote (x2=6.955,df=1, adj.p< 0.01). Among physicians who did not use a personal endorsement, the next best predictor of vaccine compliance was spending 10 minutes or more discussing vaccination (x2=7.418, df=1,adj.p< 0.05). Conclusion This study contributes to a nascent body of literature related to paediatricians’ experience with vaccine hesitancy in a Canadian context, particularly as it relates to the impact of hesitancy on practice. This study demonstrates the ubiquity of hesitancy in clinical practice, the profound impact of hesitancy on paediatricians and highlights promising responses to parental hesitancy that may improve vaccine compliance. Future research should explore potential hesitancy interventions including using a personal endorsement and prolonged engagement using more rigorous methods of evaluation. Disclosures Kate E. Allan, PhD, Pfizer (Other Financial or Material Support, Postdoctoral Fellowship at the Centre for Vaccine-Preventable Diseases (at University of Toronto) is funded by Pfizer.)

EPOS 4 Patients

EPOS2020 is the 4th and most recent version of the European Position Paper on Rhinosinusitis and Nasal Polyps which was first published in 2005. It aims to provide the most up to date scientifically robust information on the topic published in the literature which has been critically analysed by an international group of clinicians drawn from all disciplines dealing with these problems together with patients. The guidelines offer evidence-based recommendations and care pathways for acute and chronic rhinosinusitis in both adults and children. Management of these diseases from the patients' perspective is an important part of EPOS2020. Not only is this included in the main document but, for the first time, we have produced a separate supplement dedicated to and in collaboration with patients, EPOS4Patients, which aims to provide information in an accessible format, to answer frequently asked questions about these diseases and their treatment options as well as including useful patient resources and websites. It has never been more important for patients to be actively involved in their care. Being well informed helps you to make the best decisions together with your doctor.

Patient Resources in a Cancer Center

Despite the emergence of more effective targeted therapies, cancer treatment remains a complex process requiring a holistic patient-centered approach, beyond the direct medical care offered by the treating hematologist/oncologist. This entails empowering patients with knowledge about prescribed regimens and their risks and side effects, within a multifaceted treatment team involving hematologists/oncologists, advanced practice providers, nurses, nutritionists, and pharmacists, among others. Additionally, a multitude of resources are generally available including financial, religious, and spiritual support to help patients in the treatment journey. This chapter describes resources generally available to cancer patients, as well as an array of supporting services in a cancer center to address the patient needs.

Assessing Resources in a Population of Hemodialysis Patients: A New Approach to Improve Quality of Care

Hemodialysis patients constitute a vulnerable population. Their health needs are considerable and they often present psychological symptoms such as depression and anxiety. Empirical studies have demonstrated the efficacy of positive psychology interventions to enhance the well-being of patients and alleviate their depressive symptoms. One such intervention consists in identifying and mobilizing patient resources to activate their recovery. An intervention of the sort was implemented in Switzerland with hemodialysis nurses using AERES, a novel self-assessment instrument. AERES covers 31 domains under three dimensions: personal characteristics/qualities, hobbies/passions, and social/environmental resources. The aim of this qualitative study was to explore hemodialysis nurse perceptions of the use of this instrument. Sixteen hemodialysis nurses were recruited in six hospitals in French-speaking Switzerland and interviewed after delivering the intervention. A consensual qualitative research method was used to analyze the data. Results showed that the resources instrument was easy to administer and beneficial to patients and health professionals. Patient wellbeing became the top priority for the nurses and new interventions centered on patient resources were undertaken. Quality of patient care was improved. Nurses perceived this positive psychology instrument as a means of creating a positive relationship with patients and supporting them emotionally. Assessing the resources of this vulnerable population can provide health professionals with a powerful tool to understand patient intact resources, which can be used to alleviate symptoms and foster wellbeing.

Building out lifelines for safety, trust, empowerment, and renewal: Development, feasibility, and acceptability of the BOLSTER intervention for patients with gynecologic cancers and their caregivers.

187 Background: Peritoneal carcinomatosis (PC) afflicts over half of women with advanced gynecologic (GYN) cancers. Patients with PC often require ostomies, gastric tubes, or catheters to palliate their symptoms, yet patients and caregivers report feeling unprepared to manage these devices at home. Our aims were to develop and assess the feasibility and acceptability of an intervention (BOLSTER) to support patients with GYN cancers and their caregivers after hospitalization for PC. Methods: We used the ADAPT-ITT approach to adapt components of the Standard Nursing Intervention Protocol for the target population. First, we assembled a team of stakeholders and topical experts to identify gaps in patient resources. Next, we developed patient- and family-centered educational materials. We augmented written materials with illustrations and produced short videos of patients and caregivers managing medical devices. We developed a protocolized manual for a baccalaureate-prepared nurse to provide care coordination, skills training, and symptom management education across several in-person or telehealth visits. We also created a smartphone application to assess patient-reported outcomes, deliver tailored educational content, and trigger clinical action between visits. Finally, we assessed the feasibility and acceptability of two iterations of BOLSTER in single-arm pilot studies of English-speaking adult patients hospitalized for PC and their caregivers. We defined feasibility as a ≥50% consent-to-approach ratio and acceptability as ≥70% of participants recommending BOLSTER. Results: Intervention characteristics during and the results of each single-arm pilot study are shown in Table. In the first single-arm pilot, 2/4 participants declined home visits, 2/4 wished BOLSTER were shorter, and 3/4 desired access to BOLSTER earlier in their disease course. For the second single-arm pilot, we expanded participant eligibility criteria, eliminated home visits, and reduced the duration of the intervention. Conclusions: BOLSTER is a technology-enhanced, nurse-led care management intervention that is feasible and acceptable to patients with GYN cancer-associated PC and their caregivers. A randomized controlled pilot study of BOLSTER represents a logical next step. Clinical trial information: NCT03367247. [Table: see text]

863 Online Patient Resources to Support Shared Decision Making for Fundoplication Surgery: A Systematic Review

Aim The royal college of Surgeons’ Supported Decision-Making guidance details how patients should access information necessary to make clinical decisions alongside their medical team. As patients become more reliant on information found via the internet, it is important to ensure that there are suitable, validated, and appropriate resources. This study aims to assess the quality of online patient information related to anti reflux (Fundoplication) surgery and we believe this review is first of its kind with regards to surgery for gastroesophageal reflux disease. Method A comprehensive, targeted search was made of online healthcare information relating to Fundoplication surgery. Search terms ‘fundoplication’ and ‘anti-reflux surgery’ were entered into three main search engines using a pre-defined search strategy. Websites were assessed according to their readability (Klesch-Kincaid Reading Ease Score), quality and content (International Patient Decision Aids Standards (IPDAS) and DISCERN scores) as well as the presence of accreditation. The PRISM and AMSTAR guidelines have been followed in this article. Results Overall, 74 sources from three search engines were found. Duplicates were removed and pre-defined eligibility criteria applied, giving 40 sources for analysis. The mean readability score was higher than the recommended score for patient education materials, while the IPDAS and DISCERN scores were low. There were only 22.5% of the websites accredited by the HANcode. No statistical significance was found on the overall quality of websites between the accredited and non-accredited websites Conclusions Patient information available online for fundoplication is difficult to read and of poor quality impacting negatively on shared decision-making.