Physical Therapist Training Challenges for an Embedded Pragmatic Trial: Fibromyalgia TENS in Physical Therapy Study

Transcutaneous electrical nerve stimulation (TENS), a non-pharmacological treatment, is safe and effective for movement-evoked pain in individuals with Fibromyalgia (FM). The purpose of our NIH-funded pragmatic clinical trial, Fibromyalgia TENS in PT Study (FM-TIPS), assesses feasibility and effectiveness of adding TENS to usual physical therapy (PT) treatment in individuals with FM. We partnered with 33 sites in 6 healthcare systems, training 150+ Midwest clinicians. Outpatient PT clinic sites are cluster randomized to a TENS or a No-TENS intervention, stratified by system and clinic size. We will recruit ∼600 patients with a primary or secondary diagnosis of FM. We developed comprehensive communication and training procedures to ensure study fidelity and adapted over the course of the study to enhance learning. We will provide an overview and the impact of the pandemic on these procedures. Representatives for each healthcare system, each clinic and the study team were identified for communication and training. Training included initial study introduction, human subjects protection, and study procedures. We used a hybrid approach with written, video, onsite, and virtual instruction. All materials and procedures, for clinician and patient-facing materials, website, videos, equipment use (iPad for screening, TENS units), and clinician procedures for PT visits 1-3, were piloted and reviewed by clinicians from each healthcare system. Additional communication and feedback include weekly enrollment reports, monthly newsletters, relationship building with clinicians, enrollment incentives, and continuing education webinars. The pandemic required creative and evolving solutions to maintain study involvement and recruitment. Barriers for enrollment are screening PT Visit 1, comfort level of clinicians for PT Visits 2 and 3, delays/alterations in training and planning, clinician demands, clinicians/patient illness, and staff shortages in the clinics. Current enrollment, study training and implementation has been affected by COVID-19 and we developed creative methods for training and implementation for FM-TIPS. Grant support from Research supported in this USASP was supported by National Institutes of Health Heal Initiative Grant UG3/UH3 AR076387-01 and UL1TR002537.

Facilitators and Barriers to Implementation of a Transcutaneous Electrical Nerve Stimulation Intervention in a Pragmatic Clinical Trial

Fibromyalgia TENS in Physical Therapy (PT) Study (FM-TIPS) is testing feasibility and efficacy of Transcutaneous Electrical Nerve Stimulation (TENS). We present our experience for implementing TENS into PT clinics and virtual training to participants on TENS in a pragmatic clinical. FM-TIPS is a pragmatic, cluster-randomized clinical trial examining if the addition of TENS to routine PT improves movement-evoked pain in fibromyalgia (FM). FM patients (n=600) will be enrolled from 35 PT clinics across six Midwest healthcare systems into either a TENS or no-TENS group. All subjects randomized by TENS clinics receive TENS starting on Day 1. The no-TENS clinics start after completion of the primary outcome on Day 60. In the TENS group, Physical therapists (PTs) provide TENS education in person, while in the no-TENS group, study staff provide TENS education virtually. To facilitate implementation, we selected a study-specific TENS unit that provides mixed frequency TENS with intensity as the only adjustable parameter. All PTs were trained in proper use of the TENS unit in-person. While most PTs embraced the addition of TENS, some had not used TENS and had difficulty adapting practice to include TENS. For virtual visits in the no-TENS group, a standardized procedure was developed and completed by study staff PTs. TENS units were shipped to subject's and zoom visits were scheduled at the subject's convenience within a 10-day window. Most subjects completed virtual TENS training and implementation without difficulties. Technology limitations provided a significant barrier for some subjects. Most clinics have adopted and incorporated TENS intervention. Implementing virtual TENS training in a pragmatic trial can be successful for participant intervention. Due to the current COVID-19 pandemic, participants are more aware of the need to complete interventions via virtual mechanisms. Barriers to virtual TENS instruction are often due to internet and device limitations. FM-TIPS work is supported by the National Institutes of Health (NIH) through the NIH HEAL Initiative under award number UG3AR076387 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This work also received logistical and technical support from the PRISM Resource Coordinating Center under award number U24AT010961 from the NIH through the NIH HEAL Initiative. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or its HEAL Initiative.

Corrigendum: COVID-19 Driven Adaptations in the Provision of School Meals in the Baltic Sea Region(Front. Sustain. Food Syst., (2022), 5, (750598), 10.3389/fsufs.2021.750598)

In the original article, we neglected to include the funder the Polish Ministry of Science and Higher Education Programme “PMW,” GrantNo. 5170/INTERREG BSR/2020/2 to Rita Góralska-Walczak and Renata Kazimierczak. Copyright © 2022 Ala-Karvia, Góralska-Walczak, Piirsalu, Filippova, Kazimierczak,Post, Monakhov and Mikkola.

Exploring Cancer Registrars' Perceptions of the Quality and Use of Cancer Registry Data for Care Coordination and Other Purposes

BACKGROUND: Hospital cancer registry data are used for a variety of aspects of patient care, yet one of the lesser used purposes of cancer registry data is to improve care coordination. OBJECTIVES: The purposes of this study were to assess hospital cancer registrars' perceptions of (1) the use of and quality of hospital cancer registry data for care coordination and other purposes;(2) the availability of all needed data for complete hospital cancer registry data collection;and (3) the data collection of COVID-19 effects on cancer patients. METHODS: A survey was sent to hospital-based members of Cancer Registrars of Illinois between April and June 2020. Survey questions focused on current use and quality of hospital cancer registry data for care coordination as well as items related to COVID-19's effect on cancer patients. The focus of this study was hospital-based registrars, as they are the individuals collecting data directly from primary patient records. RESULTS: While hospital cancer registry data are being used for many purposes including continuity of care, this study found that providers are not using hospital cancer registry data to its fullest extent. It was also found that hospital cancer registrars have collected valuable data on the impact that COVID-19 has had on cancer patients. CONCLUSION: Care coordination between providers is especially important for cancer patients who may see multiple providers and visit several facilities. This study found that the hospital cancer registry database contains extremely useful data for cancer patients and practitioners. Further, it was found that the hospital cancer registry is a source of valuable information regarding the impact that COVID-19 has had on cancer patients.

Impact of COVID-19 on a Pragmatic, Cluster Randomized Clinical Trial for Fibromyalgia

Our objective was to present our experience on adapting to the challenges of COVID-19 pandemic on a pragmatic clinical trial. Transcutaneous Electrical Nerve Stimulation (TENS) in Physical Therapy (PT) Study (FM-TIPS) is a pragmatic, cluster-randomized clinical trial examining if the addition of TENS to routine PT improves movement-evoked pain in fibromyalgia (FM). FM patients (n=600) were enrolled from 24 PT clinics (12 PT only, 12 PT with TENS) across five healthcare systems. COVID-19 has significantly impacted PT practice and in-person interactions. In response, all PT clinics saw reduced volumes of patients, some clinics furloughed PTs, and some clinics were permanently closed. This led us to put contracts, reliance agreements, and training of clinics on hold and to seek additional clinics that could fill the gap for those who could no longer participate. It also led to a delay in onboarding healthcare systems and inpatient enrollment. In order to protect the integrity of the study and minimize missing data due to potential restrictions of in-person visits we developed alternative strategies. This includes procedures for home instruction of TENS via telehealth, a plan for bringing on backup clinics, and a plan for training virtually and in-person using personal protective equipment and social distancing. Assessment of primary outcome and questionnaire data were transitioned for the patient to perform at home through a patient-portal with embedded patient-specific videos. We have also set up a phone line for patients to call with additional questions or concerns. The impact of COVID-19 on statistical design and analysis was discussed including a plan for uneven enrollment across clinics and a sub-analysis of data for patients enrolled during or after the pandemic. In conclusion, COVID-19 altered the original study design of this large-pragmatic trial to account for greater flexibility for providers and patients to facilitate continued enrollment. NIH.

Integrating pragmatism and rigor - impact of the pandemic on a randomized controlled trial of a complex intervention

The objectives here were to present a model of transparent reporting and pragmatic RCT design adaptation, and to promote discussion regarding best practices for overcoming the challenge of detecting intervention-specific changes in pain within the context of variable psychosocial factors due to the pandemic. Methods included an ongoing randomized, double-blind, placebo-controlled trial is examining the effect of pain education combined with exercise on pain in patients with chronic Achilles tendinopathy. We hypothesized that a biopsychosocial approach to patient education would reduce movement-evoked pain more than standard care (biomedical education and exercise). Since March 2020, challenges have included a temporary halt of in-person human subjects research, adapting virtual screening procedures to maintain confidentiality and safety, need to obtain telehealth license in multiple states, inability to use specialized laboratory equipment to evaluate secondary outcomes, and gradual resumption of in-person visits with PPE. As COVID-19 prevented the trial from proceeding as planned, we adapted our design to both exploit new opportunities and maintain high standards of transparency and rigor. We maintained study enrollment by modifying screening, evaluation, and treatment to accommodate virtual participation with consistent content. We adjusted our aims to include an a priori hypothesis that differential effects of a biopsychosocial versus biomedical approach on pain may be magnified during a pandemic. Additionally, strategies developed to adapt to an altered research-environment may be useful tools for future RCTs to facilitate participant recruitment and retention. We logged changes in a time-stamped manner on Open Science Framework;full disclosure will be ensured in final reports at Clinicaltrials.gov and publications. Adaptive designs are at risk of low confidence unless full transparency is integrated into research processes. Our own efforts to integrate changes to research design and conduct, with contemporary standards of transparency and rigor, provide opportunities for future research practice during and post-COVID. Funding for this study was provided by the National Institute of Arthritis Musculoskeletal and Skin Disease (NIAMS) research grant R00 AR071517 and by the Collaborative Research Grant from the International Association for the Study of Pain (IASP). Research reported in this publication was supported by the National Center for Advancing Translational Sciences of the National Institutes of Health under Award Number UL1TR002537. These funding sources had no role in study design, collection, analysis/interpretation of data, or decision on submission for publication. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

3-IN-1 HYBRID LEARNING ENVIRONMENT

We propose a learning innovation called 3-in-1 Hybrid environment as a solution for educational institutions to meet the challenge of balancing campus reopening against public health risks amid the COVID-19 pandemic. Our proposed innovation provides students options to attend class synchronously (either face-to-face or remote) or asynchronously (online) in an interactive learning environment that promotes emotional, behavioral, and cognitive engagement. We designed and implemented a large Marketing Management class with over 800 students as a 3-in-1 course. We examined its effectiveness in an empirical study and found that (1) students have a positive attitude toward 3-in-1 Hybrid learning;(2) they show a high level of synchronous attendance and a low number of missed quizzes and homework;and (3) their quiz performance is a strong mediator on the relationship between synchronous attendance and actual learning. Our study provides empirical evidence to support the promises of the proposed 3-in-1 Hybrid environment to address logistical and pedagogical challenges of student engagement in large class learning. © 2020 Society for Marketing Advances.