DOI: 10.31038/JCRM.2020326

Abstract

The study, Telemedicine: Enabling Patients with Arrhythmias in Self-Care Behaviors study is designed for early recognition and treatment of an arrhythmia and optimizing patients’ medication, activity, and arrhythmia self-efficacy. Telemedicine is a method which allows health care professionals to evaluate, diagnose, and treat patients within their homes and remote locations [1]. Connecting with patients via video and telephone visits allows the caregiver access and assists the patient in improving self-care behaviors and self-efficacy in managing arrhythmias [1,2]. This pilot telemedicine study provides earlier diagnosis of abnormal arrhythmias and increased patient involvement and self-efficacy of one’s health care solutions [2]. The Telemedicine: Enabling patients in Self-Care Behaviors study started in February 2020, prior to the onset of the Covid 19 pandemic. The study has been placed on hold since March 17, 2020. In a response to the Covid-19 pandemic (separate from this study) multiple medical and nursing practices have adopted telemedicine to maintain ongoing care appointments [3]. The study displays the complementing use of three survey tools (Medication Understanding and Self-Efficacy Tool, Functioning Self Efficacy Scale, and Arrhythmia Specific questionnaire in Tachycardia an Arrhythmia) with monitoring devices (loop recorders, Kardia-TM, pacemakers and cardioverter defibrillators-ICDs) coupled with telephone and video visits to pinpoint arrhythmia changes and exact patient reactions and discussion to reinforce self-efficacy behaviors.

Keywords

Telemedicine, arrhythmia, self-efficacy, behavior.

Introduction

The purpose of the study, Telemedicine: Enabling Patients with Arrhythmias in Self-Care Behaviors (T:EPASB) is to provide an alternative to in person visits, decreased the time of diagnosis and treatment of an arrhythmia via the internet, and enable patients to improve self-efficacy of arrhythmia care behaviors. Self-efficacy can be defined as the individual’s belief in oneself to handle a set of circumstances or changes in physical or mental well-being [2].

The first outcome of the study is to determine if subjects in a telemedicine program for the care of cardiac arrhythmias have  any difference in [1] time of arrhythmia recognition [2], time of arrhythmia diagnosis by a healthcare provider, and [3] time of treatment initiation compared with patients enrolled in standard care for cardiac arrhythmias. The second outcome of the study examines subjects’ self-efficacy of medication use, functional self-efficacy, and arrhythmia self-efficacy. A data collection tool was utilized with a simplistic check off system used to mark when one recognized changes in symptoms such as increased palpitations, fatigue, activity intolerance, shortness of breath, and any other change in symptoms associated with an arrhythmia. The tool allowed for quick responses to these symptoms with self-initiated blood pressure check, heart rate check, increased fluids, or taking an additional beta blocker, sitting down and resting, and calling the electrophysiology (EP) office for advice (Appendix A).

Background Information

University based tertiary care clinics, which  treat  irregular heart rhythms, are known as arrhythmia clinics and formally called electrophysiology departments [4]. These departments have been in existence prior to the early 1960’s and their technology has continued to evolve over time. The need to meet with patients and discuss  their abnormal and irregular heart rhythms has entailed prescribing medications to slow the heart rate, prescribing medications to eliminate abnormal heart rhythms, and implanting devices to further control the heart rhythms, known as pacemakers (PPM) and implantable cardioverter-defibrillators (ICDs) [4]. The continued improvement in technology and expansion of such departments has led to a need for increased numbers of patient appointments, dual appointments for arrhythmia management and pacemaker or ICD management, and coordinated appointments with other cardiology sub-specialties [5]. This increased frequency and duration of appointments places stress upon patients with longer drives, wait times, financial stressors of parking, food, and gas costs in reaching such appointments [6]. With such stressors, a need for computer assisted video visits has evolved [6]. The monitoring  of  arrhythmias  involves  home  monitoring via external disposable monitors which are affixed on  the chest wall, small implanted monitors (loop recorders), and utilizing the monitoring features of permanent pacemakers (PPMs) or implantable cardioverter defibrillators (ICDs).

Review of literature

The T:EPASB is based upon studies showing improved clinical outcomes with the use of telemedicine. The TRUST trial compares the use of a telephone video conference to conventional in person visits with individuals with ICDs. The TRUST trial determined the efficacy and safety for monitoring ICDs and the reduction of in person visits [7,8]. This study displayed an adverse event rates of 10.4 for each group [7,10] and no difference in the telemedicine versus the in person visit group.

The Poniente trial determined there was no difference in arrhythmia detection and functional capacity in monitoring elderly patients with pacemakers via home monitoring compared with in person monitoring [9]. The CHOICE AF was a pilot study to test the feasibility of brief telephone-based program to target improving cardiovascular risk factors and health related quality of life in patients with atrial fibrillation [11], showing great potential for a telephone- based program.

A study by Ryan et. al. (2018) [13] verified the efficacy of theory based Integrated Theory of Health Behavior Change (ITHBC) intervention utilizing a cellular phone application to increase women’s initiation and long-term maintenance of osteoporosis self-management behaviors. This study takes a chronic disease state, osteoporosis, and combines ITHBC prompted behaviors with a cellular phone application to assist women in behavior change. Suter et. al. (2011) [14] used self-efficacy as a key component in managing one’s health noting patient empowerment in the management of chronic disease conditions such as diabetes mellitus and heart failure. The study identified the essence of telemedicine in its ability to empower patients with skills in managing one’s chronic health condition.

Theoretical Framework

Integrated Theory of Health Behavior Change (ITHBC) was used in guiding this study as it notes the importance in assisting individuals in becoming increasingly involved in their own health care [2]. This theory links a relationship between the way one views one’s own health care and an overall sense of wellness. Dr. Ryan’s study of those with chronic health care diagnosis’ and improving specific health care behaviors highlighted the need to 1) have a change in how one reacts followed by 2) one’s resultant behavior with an improved sense of wellness (when assisted with behavior changes). Essential components for behavior change include a desire to change, self- reflection, positive social-influence and support required in creating the change [2].

Methods and Materials

The study is a prospective randomized controlled study, in which informed consent was obtained. Randomization included subjects picking from sealed envelopes which were numbered, labelled with a folded card within each envelop stating either standard versus telemedicine visits. The University of Michigan Hospital IRB number: IRB00001995.

Inclusion/Exclusion Criteria:

Methods

The study was introduced to the subjects during an initial meeting with an explanation of the study and an explanation of the consent. After the informed consent was obtained, the subjects were randomized into telemedicine or standard in person six- month visits.

With the initial visit, surveys were completed with telemedicine and standard visit groups. Telemedicine subjects received monthly visits for three consecutive months and standard received a six month return visits (Appendix B-study schematic). Interventions provided to the telemedicine group included discussion and reinforcement of medication, functional activity and arrhythmia self-efficacy, guided discussion, and social support.

The surveys utilized were the Medication Understanding and Self-Efficacy Tool, Functioning Self Efficacy Scale, and Arrhythmia Specific questionnaire in Tachycardia an Arrhythmia (MUSE, FSES, ASTA) surveys. All three surveys were provided on the first day of the study to each study group subject and on the last day of the study for each study group subject. Key questions were compared with a calculation of the mean for these questions, comparing the standard group with the telemedicine group. (Appendix C, D, E– MUSE, FSES, and ASTA surveys).

There were chart reviews and analysis of monitored data from devices  revealing  onset  of  arrhythmias,  times  of  diagnosis’  and treatments in the telemedicine group compared with the standard group. The T:EPASB utilizes the null hypothesis to demonstrate no difference in time of recognition of an arrhythmia, time to diagnosis and treatment of the arrhythmia, between the telemedicine group as compared with the standard group. The null hypothesis is be used in the Medication Understanding and Use Self- Efficacy (MUSE), ASTA (Arrhythmia Specific questionnaire in Tachycardia and Arrhythmia) and FSES (Shortened Functional Self Efficacy Scale) surveys. A paired T test with the difference in the means of answers to survey questions was utilized in calculating a P value for select survey questions (Appendix C).

Measures

Arrhythmias can be multifactorial and can cause no perceived symptoms versus serious symptoms such as palpitations, fast and pounding heart beats, sweating, chest pain and or pressure, anxiety, fear, and depression [15]. One single survey may not capture the data experienced by the subject and not every survey relates to the self- efficacy of these perceived events. The MUSE survey gives information on medication compliance, cost barriers, number of medications, physicians and pharmacies and hospitalizations. The FSES gives a scale of the subject’s self- efficacy to cope with the arrhythmia and day to day functioning. The ASTA survey is the most specific survey to arrhythmias and the symptoms associated with arrhythmias; but does not reflect the medications or functional capabilities.

The MUSE survey was tested for validity and reliability in measuring   patients’ self-   efficacy   in   understanding   and   using prescription medications [12]. FSES displayed good internal consistency and satisfactory criterion and convergent validity in assessing the degree of confidence self-functioning while facing decline in health and function [16]. ASTA, displayed content validity for all items, and internal consistency [17].

Data Collection Sheet and Demographics:

Pilot Study Results

From late February 2020 to March 2020, 9 patients were enrolled in the Telemedicine study and randomized to either standard visits or telemedicine visits. Three patients declined the study, one patient noted he would join the study, but only if he received a Kardia monitoring device (he was not enrolled in the study as this could not be guaranteed and he noted his intention of simply gaining the Kardia device) and was not enrolled due to ethical concerns.

All subjects signed the informed consent and received copies of the protocol and consent, including the clause that they may drop out of the study. Each subject was given instruction on filling out surveys and were given the opportunity to answer questions by the nurse practitioner (NP) in clinic and the research assistant. The surveys were reviewed and scored by the research assistant and double scored with the author of the study. The surveys pinpointed the overall arrhythmia burden, degree to which subjects felt the arrhythmia, and physical and mental coping levels in relation to the arrhythmia. The surveys gave the caregiver (Nurse Practitioners and Physician Assistants within the EP clinic) specific areas to discuss, reinforce, and empower the subject in arrhythmia behavior change. The time of recognition, diagnosis and treatment of arrhythmias was deferred due to the Covid 19 pandemic and this monitoring data is attained only for daily arrhythmia management.

Appendix D gives the overview of all survey results for T:EPASB. The overview gives the researcher a quick glimpse of any problem areas such with decreased self-efficacy of medication use, or functional capacity or arrhythmia knowledge and understanding.

Results of the MUSE survey show near complete compliance in medication use with only one missed dose of medications from one subject. MUSE tallied results also show no financial constraints to medication obtainment in all nine subjects. There was a 0.8679:1 ratio with number of number of physicians treating to number of medical diagnosis; with a mean of 2.89 physicians prescribing medications to a mean of 3.33 medical diagnosis for the 9 subjects evaluated (Appendix B). When combining the surveys, key data becomes clear. The subjects scoring the lowest functional status self-efficacy, subject 5a and subject 9a with scores of 43 and 44 respectively, scored 37 and 54 respectively on the ASTA arrhythmia burden survey. One can note poor functional self-efficacy, but not necessarily related to arrhythmia burden in subject 5a, while poor functional self-efficacy may be related to a higher arrhythmia burden in subject 9a. Another complementing data point will be specific arrhythmia logs within monitoring- devices; once this deferred data is allowed within the study. Another interesting finding is the subject 8a who has a high arrhythmia burden noted with ASTA of 46, but a very good FSES score of 64.

Discussion

The T:EPASB pilot study has shown the importance of offering an alternative to conventional in person visits, offering counseling in  managing  one’s  self-efficacy  for  arrhythmia  care,  and  providing reinforcement and social support in managing one’s arrhythmia care. The study illustrates the importance of gathering complementing data on arrhythmia management including medication use and understanding, functional self-efficacy, and arrhythmia self-efficacy. The triad of these surveys provides an excellent overview of one’s arrhythmia self-efficacy. With such data, the medical and nursing provider may offer patient specific counseling. There is an advantage of having a specifically timed event, match a corresponding subject’s complaint. The use of implanted and portable monitoring data gives an excellent overview of the subject’s associated heart rhythm abnormality. The MUSE survey used alone gives a false sense that there may not be any need for any reinforcement of self-efficacy of medication or arrhythmia understanding. When this survey is coupled with the FSES and ASTA, trends begin to develop and specific areas of intervention, such as improved daily activity levels, decreased arrhythmia burdens via medications or activity, utilization of beta or calcium channel blockers, increased fluids, and or activity training to improve arrhythmias may be discussed. The surveys when used  together  display  specific  areas  to  improve  subject’s  knowledge, one’s confidence and self-efficacy in arrhythmia management. Those with higher arrhythmia burdens in which the subject feels palpitations, fatigue, and side effects have a greater need for intervention which strengthen self-efficacy and social support for medication use, functional activities and arrhythmia management [16,17]. This pilot T:EPASB study continues to show great potential and will likely mimic the TRUST, CHOICE-AF and Poinete trials in identifying, diagnosing, and treating arrhythmias with no difference in timing of these events with telemedicine compared with in person follow up visits with prompt device monitoring. The study has already helped to pinpoint areas of difficulties with arrhythmias, medications, and functional capacity. Via interventions such as affirming knowledge, counselling medication usage, and validating activity and exercise efforts and knowledge, the caregiver  may  help  improve  the  subjects’  overall  functional  capacity in coping with one’s arrhythmia. The study’s evaluated questions have not reached significant p values, as the study has been Anecdotally, the overall response to telemedicine has been very positive with comments like, “this is so much better”, “I can concentrate on what you are teaching me, without the long drive” and “this information seems to stick much better, when I learn it at home” and “can we make more telemedicine appointments”. The T:EPASB study can in no way be fully assessed at this early point, but its potential to assist in improving patients’ self-efficacy via increased patient interaction, reinforcement of arrhythmia details, and social support will surely lead to further studies using telemedicine and a triad of survey tools.

Authorship:

Kathleen Fasing, DNP-c, MS,

ACNP Madonna University,

Livonia MI

University of Michigan, Staff ACNP, Ann Arbor, Michigan

kfasing@med.umich.edu

DNP Project Chair: Patricia Clark, DNP, RN, ACNP-BC,

ACNS- BC, CCRN, Madonna University,

pclark@madonna.edu

DNP Project Member: Rachel Mahas, PhD, MS, MPH,

Madonna University, rmahas@madonna.edu

DNP Project Member: Vicki Ashker, DNP, MSA, RN,

CCRN, Madonna University, vashker@madonna.edu

Milwaukee- Self Management Science for your great research on self- efficacy and your ITHBC theory and allowing its use.

Sara Carmel- Ben Gurion University of Negev- Public Health Faculty Member- for your behavior research and functional self- efficacy tool and allowing its use.

Ulla Walfridsson RN, PhD-Division of Nursing Science; Dept of Medicine & Health Sciences, Linkping, Sweeden- for sharing your incredible arrhythmia assessment tool and allowing its use.

Sangeeta Lathkar-Pradhan- Research Assistant for ongoing support and patience.

Rachel Wessel- Research Assistant for exacting perseverance.

Hakan Oral, MD- University of Michigan EP Director- thanks for believing in me.

Dr. Patricia Clark- DNP committee lead and advisor and patience extraordinaire.

My husband- Gregory Fasing BSN, RCIS- for his forever support.

Acknowledgements

Thank you so much for all who assisted in this project including and in equal acknowledgement.

Polly Ryan PhD, RN, CNS-BC – University of Wisconsin

References

1. Kay, Misha, Santos, Takane (2010) Telemedicine opportunities and development in member states, Global observatory for eHealth series, virtualhospital.org.uk. (1,2). [crossref]
2. Ryan, P. (2009) Integrated theory of health behavior change: Background and intervention development, Clinical Nurse Specialist, 23 (3): 161-172. (3, 5,18,19). [crossref]
3. Lovett-Rockwell, K. & Gilroy, A. (2020) Incorporating telemedicine as part of COVID-19 Outbreak response systems, The American Journal of Managed Care, 26 (4): 147-148. Doi.org/10.37765/ajmc.,(4). [crossref]
4. Fozzard (2011) History of basic science in cardiac electrophysiology, Cardiac electrophysiologycinics, 3, 1, 1-10. Doi:10.1016/j.ccep.2010.10.010,(6,7). [crossref]
5. Phend, C. (2020) Telehealth shaping up for Covid-19- Cardiology illustrates what specialties can do to be ready, Medpage today.,(8).
6. Maffei, R., Hudson, Y. & Skim Dunn, M. (2008) Telemedicine for urban uninsured: A pilot Framework for specialty care planning sustainability, J E health, 14(9), 925- 931 [crossref]
7. Dalouk,  K.,  Gandhi,  N.,  Jessel,  P.,  MacMurdy,  K.  et.  al.  (2017)  Outcomes   of telemedicine  videoconferencing  clinic  versus   in-person   clinic   follow-up for implantable cardioverterdefibrillator recipients, Circulation arrhythmia electrophysiology, 10, (11,13).
8. Varma, N., Epstein, A., Irimpen, A., Schweikert, R., & Love, C. (2010) Efficacy and safety of automatic remote monitoring for implantable cardioverter-defibrillator follow-up: The Lumos-T safely reduces routine office device follow-up, TRUST trial, Circulation, 122: 325332.,(12). [crossref]
9. Lopez-Villegas, A., Catalan-Matamoros, D., Robles-Musso, E., & Peiro, S. (2015) Effectiveness of pacemaker tele-monitoring on quality of life, functional capacity, event detection and workload: The PONIENTE trial, Geriatrics and gerontology international, 16 (11).,(14). [crossref]
10. Varma, N. & Ricci, R. (2013) Telemedicine and cardiac implants: what is the benefit? European heart journal, 34 (25), 1885-1895.(15).
11. Lowres, N., Redfern, J., & Freedman, S. (2014) Choice of health options in prevention of cardiovascular events for people with  atrial  fibrillation  (CHOICE  AF):  A  pilot study, European journal of cardiovascular nursing, doiorg.proxy.lib.umich. edu/10.1177/14745114549687. (16). [crossref]
12. Cameron, K., Ross, E., Clayman, M., Bergeron, A., et. al. (2010) Measuring patients’ self-efficacy in understanding and using prescription medication, PatientEducation Couns, 80 (3); 372376. Doi: 10.1016/j.pec.2010.06.029.,(17,21). [crossref]
13. Ryan, P., Papanek, P., Csuka, M., Brown, M., et. al. (2018) Background and method of the striving to be strong study, a RCT test the efficacy of a mhealth self-management intervention, Contemporary Clinical Trials, 71, 80-87.,(16). [crossref]
14. Suter, B., Suter, W. N., & Johnston, D. (2011) Theory-based telehealth and patient empowerment, Population Health Management, 14 (2).,(19). [crossref]
15. Withers, K., Wood, K., Carolan-Rees, G, Patrick, H., et.al. (2015) Living on a knife edge- the daily struggle of coping with symptomatic cardiac arrhythmias, Health quality life outcomes, 13:86.,(20). [crossref]
16. Tovel, H. & Carmel, S. (2015) Functional Self-Efficacy Scale- FSES: Development, evaluation, and contribution to well-being, Research on aging, 1-22. Doi: 10.1177/0164027515596583. (16,22,24). [crossref]
17. Walfridsson, U., Arestedt, K., & Stromberg, A. (2012) Development and validation of a new arrhythmia-specific questionnaire in tachycardia and arrhythmia (ASTA) with focus on symptom burden, Health quality life outcomes, 10-44, doi: 10.1186/1477- 7525-10-44.,(23,25). [crossref]

Appendix A. Data Collection Tool- Aid for patient at home.

2 points each for every activity noted along the vertical axis; showing an activity taken due to the symptom noted on the horizontal axis. Subject to keep weekly log of number of symptoms and number of points for response activities.

Appendix B: Study Schematic

Appendix C: Three Surveys

Walfridsson, U., Arestedt, K., & Stromberg, A. (2012) Development and validation of a new arrhythmia-specific questionnaire in tachycardia and arrhythmia (ASTA) with focus on symptom burden, Health quality life outcomes, 10-44, doi: 10.1186/1477- 7525-10-44.,(23,25).

Appendix D: Scores of completed surveys:

Survey Scores: Key- Muse– Shows any difficulty in taking; or understanding medications. FSES–

highest the better functional status; highest possible =65. ASTA– the highest the worse arrhythmia burden, symptoms, and mental and physical QOL.

Appendix D. – Answers to the above scores

Muse Survey Answers

Question 1– How many prescriptions medications do you take regularly?

Mean= 5.33 medications; Median 4 Medications; Mode 5 medications with a low answer of 2 and high answer of 19 medications.

Question 2– During the past have you forgotten to take any medication? “Only 1 yes.

Question 3– In the past did you not fill or stop taking the prescription due to cost? All answered no.

Question 4– In a typical month how many pharmacies do you use; including mail order? Six subjects answered 1/ 3 subjects answered 2.

Question 5– Have you been admitted to the hospital in the past six months? –Three subjects -yes.

Question 6– How many physicians prescribed medications for you in the past year? – mean answer 2.89.

Question 7– How many medical conditions which you are receiving treatment? – mean answer 3.33

FSES Shortened Survey * Higher scores showing better functional status

This survey gained very differing results for patient. Two subjects scored the total possible of 65 points indicating the best functional status and answered 5 (maximal score) for all 13 questions. One subject answered 3 for each of the 13 questions with a score of 39 and indicating day to day function was exactly in the middle of the survey. Other subjects gave a variable scoring with specific areas and gave a scattered response, depending upon the question. Two of the subjects gave responses in the 2 range, or lower level of functional capabilities. Scores listed in 1a-9a order: 65/ 57/ 53/ 65/ 43/ 39/ 63/ 64/ 44.

ASTA Survey The survey is scored into three categories- presence of arrhythmia, symptoms associated with the arrhythmia and Health related Quality of life (QOL)- both mental and physical. Higher the score- the higher the arrhythmia burden, more symptoms and more impact on the health related QOL. Scores listed in 1a- 9a order: 39/39/38/21/37/50/21/46/54.

Appendix E.

Average Scores Pre and Post (n=9)

DOI: 10.31038/JCRM.2020325

Abstract

Objective: COVID-19 became a pandemic and has caused a global emergency in the healthcare sector. Dental professionals pose high risk of viral spreading. This systematic review focused on COVID-19 infection control protocols in oral and dental medicine to derive an evidenced-based guideline.

Method: An electronic and manual search was performed for articles related to the outbreak of COVID-19 published between 2019/11/01 and 2020/03/31.

Results: Of the 53 titles retrieved by the systematic search, a total of 6 full-texts were included for data extraction.

Conclusions: Dental treatment must be limited to emergencies during the pandemic. Strict adherence to the hygiene chain is a prerequisite for the control of further transmission and protection of dental professionals. The use of aerosol-producing therapies must be minimized. Establishing regional dental emergency centers can help maintain the necessary capacities for society while maintaining appropriate hygiene standards. Personal protective equipment must be used in a resource-saving manner for dental emergencies of infectious patients.

Keywords

Corona virus, SARS-CoV-2, Pandemic, Dentistry, Public health

Introduction

The previously unknown coronavirus disease 2019 (COVID-19) and the pathogen SARS-CoV-2 (severe acute respiratory syndrome) with its specific virulence and pathogenesis quickly became  a  global pandemic [1]. The rapid spread from human-to-human through saliva, blood, and other body fluids have made it difficult to precisely determine its transmission pattern, extent of spread, and dangerousness. These factors, along with the fact that symptoms of COVID-19 infection are similar to types of viral influenza, led to an initial underestimation of the scale of the problem [2,3].

COVID-19 emerged in Wuhan City – capital of Hubei Province in China – and rapidly spread through South Korea, Japan, and Australia, then to Europe and the Middle-East, and recently North and South America [4]. The outbreak has spiraled into a global emergency for the healthcare sector, with wider economic damage and social restrictions, and unpredictable consequences in the future [5,6]. The most important characteristics of a pandemic are the spreading dynamics in time and space, the transmission rate and pathways, the incubation period, and the proportion of severe cases and mortality rate. The apparently high virulence of SARS-CoV-2, including the asymptomatic incubation period (up to 14 days), is a particular problem in this age of globalization [7,8].

Individuals with jobs that put them in close physical contact with many other people are at the greatest risk of becoming infected by

SARS-CoV-2 and for transmitting the infection onwards. The New York Times calculated the risk to be infected by SARS-CoV-2 for various occupations based on the risk of “exposure to disease” and “proximity to other humans” [9]. Healthcare workers were found to be at the greatest risk of encountering diseases and infections and typically work in close relationship to one another and their patients. In particular, dental care providers had the highest overall risk for SARS-CoV-2 infection, based on both exposure and physical proximity to others [9]. This clearly reflects the facts that dental care providers work directly with one of the known transmission routes  of SARS-CoV-2, the oral cavity, and this is exacerbated by the use of rotating instruments or ultrasonic tips with aerosol production.

The key questions currently facing dental care workers are therefore: how should we act upon the COVID-19 crisis? And what are the adequate standards required for the well-being of patients and dental staff, considering different job groups, and also for the wider protection of society?

This review aimed to systematically screen the current literature on COVID-19 infection control protocols in oral and dental medicine to derive an evidenced-based guideline for stakeholders in the dental healthcare sector.

Methods and Meterials

The systematic review was conducted in accordance with the guidelines of Preferred Reporting Items of Systematic Reviews and

Meta-Analyses (PRISMA) [10]. An electronic search strategy of PubMed was performed for all types of publications reporting on COVID-19 in the oral medicine setting. The search was limited to articles published from around the time of the start of the outbreak to the present day (2019/11/01 to 2020/03/31). All types of publications were included. Search syntax comprised a combination of Medical Subject Headings [MeSH-Terms] and free-text words in simple or multiple conjunctions: ((“COVID-19” [All Fields] OR “2019-nCoV” [All Fields] OR “SARS-CoV-2” [All Fields] OR “coronavirus” [All Fields] OR “corona” [All Fields]) AND  (“dentistry”  [All Fields] OR “dental medicine” [All Fields] OR (“dental” [All Fields] AND “medicine” [All Fields]) OR “oral medicine” [All Fields] OR (“oral” [All Fields] AND “medicine” [All Fields]) OR “oral healthcare” [All Fields] OR (“oral” [All Fields] AND “healthcare” [All Fields]))) AND (“2019/11/01” [PDAT] : “2020/03/31” [PDAT]). An additional manual search of the bibliographies of all retrieved full-text articles and related reviews, selected from the electronic search, was conducted.

Two reviewers (T.J. and N.U.Z.) independently reviewed the titles of articles retrieved by the systematic literature search. Following this, the abstracts of all agreed titles were screened to identify articles that reported COVID-19 infection control protocols in oral medicine. The full texts of selected articles were obtained and data were extracted independently by the two reviewers using a data extraction form. Disagreements at each stage of the screening process were resolved by discussion. The following information was collected from the full text articles: a) authors including year of publication; b) country; c) publication type; and c) details of the COVID-19 infection control protocols reported in the articles.

Results

Of the 53 titles retrieved by the systematic PubMed search, 25 abstracts were further screened, and the full text of nine potentially relevant articles were obtained and reviewed. A total of six full-texts were included for data extraction, comprising four full-texts obtained from the electronic search plus one additional full-text obtained from the manual search (Figure 1) [11-16].

Figure 1. Systematic search strategy.

Included publications were categorized as four Narrative Reviews (Li & Meng 2020; Peng et al. 2020; Tang et al. 2020; Yang et al. 2020), one Discovery Report (Meng et al. 2020), and one Letter to the Editor (Sabino-Silva et al. 2020). Key recommendations for the management of COVID-19 infection control from each publication were summarized and tabulated along with the first author name, year of publication, and country of publication (Table 1).

Discussion

COVID-19 is a newly identified respiratory disease. The first case can be tracked back to 17 November 2019, according to Chinese government data [17]. Therefore, this systematic PubMed search was limited to publications reporting on infections caused by SARS-CoV-2 that were published after 1 November 2019. Publications focused on other SARS-related diseases were excluded.

Considering the recent and rapid development of the COVID-19 outbreak, it was not surprising that the identified publications from the systematic search were not clinical studies, but rather reports on self-learned experiences and trial and error management, mainly from research groups in China (five publications out of six) [11-16]. As COVID-19 continues to spread globally, it is assumed that confirmatory and/or new recommendations, and retrospective analyses of the effectiveness of different infection control protocols, will continue to be published from Europe and then from the USA [1,6,13].

The oral healthcare sector in particular has been hit hard by COVID-19 [12]. Confusion prevails due to the flood of information from policy stakeholders, statements from national dental associations, and press releases, accompanied by various (fake) posts on social media [17-21]. What infection control protocols should dental care provider follow during the COVID-19 crisis? And what lessons can the dental society learn from the COVID-19 pandemic to guide the precautions and preventative measures that may be required for future infectious diseases?

Based on the findings of this systematic review [11-16] and involving the expertise and experience of colleagues at the University Center for Dental Medicine in Basel (UZB), Switzerland, an evidence- based guideline was developed (Figure 2). This guideline was implemented on 2020/03/31 and will be reviewed and updated as new information on the COVID-19 outbreak comes to light. This guideline considers both the external and the internal dental ecosystems. On the one hand, the institutional infrastructures of dental care providers must be differentiated from an external point of view: i) Single Offices;Clinical Centers; and iii) Dental Hospitals with/without University setting including under- and postgraduate education, and clinical trials with voluntary participants and patients under dental treatment. On the other hand, possible routes of microbial transmission within the dental environment must be analyzed internally: i) dental and oral diagnostics including maxillofacial radiology and in particular aerosol-producing treatments; ii) patient flows plus accompanying relatives in waiting areas, restrooms and toilet facilities; as well as iii) employees’ facility rooms of daily use.

Figure 2. Patient flow in a centralized setting of a Dental Hospital.

In common with the rest of society, “physical distancing” is the top priority. In this context, the catchment radius of potential patients and dental staff must be taken into account for the decision who should maintain the dental care mandate during a crisis. Reducing the number of employees needed to deliver emergency dental treatments is the ultimate goal to reduce contact between people and diminish the risk of viral spreading. This will also help to preserve the supply of personal protective equipment for the protection of the high-risk group of dental care providers. Moreover, the range of dental treatments that will be delivered during the pandemic should be transparently communicated to both the dental society and to patients.

Centralization of dental emergency treatments in regional Dental Hospital settings is the key for maintain dental healthcare standards during pandemic crisis. In contrast to primary healthcare, dental procedures are usually elective. All non-urgent dental treatments must be postponed. Supplies of personal protective equipment needed by clinical staff who are treating critically ill patients in General Hospitals are critically low. If all dental care providers store and use these items for non-urgent treatments, frontline healthcare workers will be left unprotected. In case of COVID-19, it is not possible to reliably identify patients who are asymptomatically infected and most of the dental treatments produce aerosols that is known to increase exposure potential if patients are infected.

We recommend that dental care providers should focus on the management of conditions that require immediate attention to relieve severe pain and/or risk of infection and to alleviate the burden on hospital emergency departments. These comprise:

• Severe dental pain from pulpal inflammation;

• Acute exacerbation of chronic apical periodontitis;

• Acute necrotizing ulcerative gingivitis or periodontitis;

• Painful mucosal changes;

• Pericoronitis of third molars;

• Post-operative osteitis and dry-socket phenomenon;

• Infections with intra-/extra-oral swelling or abscess, particularly those potentially compromising the patient’s airway;

• Facial and/or dental trauma with avulsion, dislocation and/ or fracture;

• Uncontrolled bleeding;

• Dental treatment required prior to critical medical procedures;

• Fixation or removal of broken prosthodontic or orthodontic appliances to avoid injuries or foreign body aspiration.

If dental diagnostics and/or treatments cannot be delayed and have to be carried out related to the above list of indications, strict adherence to the hygiene chain is mandatory. In addition to the routine patient history, contactless temperature measurement using infrared thermometers should now be employed as an initial step to identify patients who are potentially infected with SARS-CoV-2.

For essential emergency treatment of patients with confirmed COVID-19, or patients with a strong suspicion of an acute infection, the following protocol should be applied by the dental care providers:

• Patients should wear masks in public and in the hospital setting;

• Patients with suspected or confirmed infection should wait in separate rooms and use indicated rest-rooms;

• Dental treatment should be conducted in an isolated and well- ventilated room (100% fresh air supply of the ventilation or air condition system instead of recirculating air is pursued);

• Use of personal protective equipment is mandatory, comprising respirators for filtering inspired air, face masks and goggles, double-layered gloves, and protective clothing, including safe disposal of used consumables;

• Patients should use pre-operative antimicrobial mouth rinse with 1% hydrogen peroxide for 30 seconds (peroxide dissolves the virus protein);

• Extra-oral dental radiographs can be used as alternatives to intra-oral imaging during the outbreak of COVID-19 to avoid any coughing of the patients;

• Emergency treatments should be as minimally invasive as possible and reduced in length and in spread of oral fluids (rubber dam and high-volume saliva ejectors to minimize aerosol);

• Treatment rooms and other areas, and used instruments, should be cleaned with appropriate virostatic agents;

• The number of dental care providers in the facility should be limited; and staff should work in weekly shifts and should be separated from household family members if they are at risk;

• Tele-healthcare should be used (whenever possible).

In addition, human resource management should consider different scenarios for work deployment plans in the Dental Hospital settings during the crisis. Tandems consisting of one dentist and one dental assistant should work together in blocks of weekly shifts to reduce interactions with other colleagues and the risk of infection. If a member of a team becomes infected, or an infection is suspected, the team should be replaced by a new tandem. Those dental personnel who have previously been infected with SARS-CoV-2, and have evidence of immunity in the form of antibodies to the virus, could take over the emergency treatments to protect the susceptible colleagues. Moreover, it must be considered whether routine testing of the dental staff should or could be carried out to clarify the infectious status of the staff in order to help prevent further transmission of the virus.

Conclusion

What lessons can dental stakeholders learn from the current COVID- 19 pandemic?

The dental profession and its special environment pose high risk of viral spreading and cross infections between patients and dental care providers. Strict adherence to the hygiene chain is a prerequisite for the control of further transmission. Dental treatment must be limited to emergencies during the pandemic. Positively tested patients or symptomatic patients with a strong suspicion of an acute infection must be treated under personal protective conditions of the dental professionals. Any aerosol-producing therapy must be reduced to a minimum.

After the successful fight against the pandemic, international standards need to be defined by a task force with experts from the public health sector, health economists, and politicians, in order to develop standard operating procedures for quickly coordinating and coping with future public health emergencies. Dental treatments are usually elective procedures. During a pandemic, it is important to establish regional dental emergency centers as quickly as possible to provide the necessary capacities for society and to ensure appropriate hygiene standards. Personal protective equipment must be used for dental emergencies of infectious patients and in a resource-saving manner.

Author Contributions

Conceptualization, Methodology, Writing-Original Draft, Writing-Review and Editing, Supervision and Project Administration:

T.J. and N.U.Z.; both authors have read and agreed to the published version of the manuscript.

Declaration of Interests

The authors declare no conflict of interest.

Acknowledgements

The authors express their gratitude to Mr. James Ashman for proofreading the final manuscript. This research received no external funding.

References

1. Tuite AR, FismanDN(2020) Reporting, Epidemic Growth, and Reproduction Numbers for the 2019 Novel Coronavirus (2019-nCoV) Epidemic. Ann Intern Med,[Crossref]
2. Cheng, ZJ,ShanJ (2020) 2019 Novel coronavirus: where we are and what we know. Infection, [Crossref]
3. Habibzadeh P,StonemanEK (2020)The Novel Coronavirus: A Bird’s Eye View. Int J Occup Environ Med, 11(2): 65-71. [Crossref]
4. Hui DS(2020)The continuing 2019-nCoV epidemic threat of novel coronaviruses to global health – The latest 2019 novel coronavirus outbreak in Wuhan, China. Int J Infect Dis, 91: 264-266. [Crossref]
5. Dey SK(2020) Analyzing the epidemiological outbreak of COVID-19: A visual exploratory data analysis approach. J Med Virol, [Crossref]
6. Wu, JT, LeungK, LeungGM(2020) Nowcasting and forecasting the potential domestic and international spread of the 2019-nCoV outbreak originating in Wuhan, China: a modelling study. Lancet, 395(10225): 689-697. [Crossref]
7. Yang W(2020) Clinical characteristics and imaging manifestations of the 2019 novel coronavirus disease (COVID-19):A multi-center study in Wenzhou city, Zhejiang, China. J Infect, 80(4): 388-393. [Crossref]
8. Zhou F(2020) Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet, [Crossref]
9. Gamio L (2020)The workers who face the greatest coronavirus risk. The New York Times,
10. Moher D(2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. PLoS Med, 6(7):e1000097. [Crossref]
11. Li ZY,MengLY (2020) [The prevention and control of a new coronavirus infection in department of stomatology]. Zhonghua Kou Qiang Yi XueZaZhi, 55(0): E001. [Crossref]
12. Meng L,Hua F,BianZ (2020) Coronavirus Disease 2019 (COVID-19): Emerging and Future Challenges for Dental and Oral Medicine. J Dent Res. [Crossref]
13. Peng X(2020) Transmission routes of 2019-nCoV and controls in dental practice. Int J Oral Sci, 12(1): 9. [Crossref]
14. Sabino-Silva R,JardimACG, SiqueiraWL (2020) Coronavirus COVID-19 impacts to dentistry and potential salivary diagnosis. Clin Oral Investig,
15. Tang, HS, YaoZQ,WangWM (2020) [Emergency management of prevention and control of novel coronavirus pneumonia in departments of stomatology]. Zhonghua Kou Qiang Yi XueZaZhi, 55(0): E002. [Crossref]
16. Yang Y(2020) Experience of Diagnosing and Managing Patients in Oral Maxillofacial Surgery during the Prevention and Control Period of the New Coronavirus Pneumonia. Chin J Dent Res, 23(1):57-62. [Crossref]
17. Davidson H (2020) First Covid-19 case happened in November, China government records show. Guardian Weekly,
18. COVID-19 Infection Control Protocols and Procedures. 2020; Available from: https://www.ada.org/en/member-center/coronavirus-resource-toolkit-for-ada-members/covid-19-infection-control-protocols-and-procedures-webinar?utm_source=adaorg&utm_medium=vanityurl&utm_content=safety&utm_campaign=covid-19.
19. Zhejiang University School of Medicine C, Handbook of COVID-19 Prevention and Treatment. 2020.
20. Coronavirus disease (COVID-19) Pandemic. 2020; Available from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019.
21. Dossier: AktuelleInformationenzum Coronavirus. 2020; Available from: https://www.sso.ch/home/coronavirus.html.

DOI: 10.31038/JCRM.2020324

Mini Review

Over the past ten years, Thrombopoietin Receptor Agonists (TPO-RAs) have become a popular treatment choice for Immune Thrombocytopenia (ITP) patients who have either failed or suffered from side effects of steroids therapy. Currently, three have been licensedfor the treatment of ITP,namely Romiplostim (Nplate, Amgen, Thousand Oaks, CA, USA), eltrombopag (Promacta, Novartis, Basel, Switzerland) and avatrombopag (Doptelet, Dova, Durham, NC, USA). Romiplostim is administered subcutaneously on a weekly schedule [1], while both eltrombopag and avatrombopag are small molecules that can be administered orally on a once-daily schedule [2, 3]. All three TPO-RAs are well tolerated with response rate defined as platelet count over 50 x10⁹/L during a finite period of time, of 60-90%. Most ITP subjects will maintain a steady platelet count with improvement of bleeding symptoms while they continue TPO-RA therapy. However, when are stopped, the platelet counts will return to base-line levels. As TPO-Ras treatment is quite expensive, prolonged use will create a significant financial burden on the health care system or patients. Recently, there were increasing reports of treatment-free durable responses after discontinuation of thrombopoietin receptor agonist.Mahevaset al [4] studied 54 adults ITP patients treated with at least one Tpo-RA over a 5-year period in France. TPO-RAs were discontinued in 20 patients who achieved a complete response and eight patients showed a mean treatment free response of 13·5 months (range 5-27 months), giving an overall off-therapy sustained response rate of 14.8%(8/54). Gonzales et al [5] evaluated treatment free response after discontinuing eltrombopag in 49 out of a cohort of 260 chronic ITP patients. Among these 49 patients, 26 maintained a platelet count ≥100×10⁹/L for at least 6 months after stopping eltrombopag without any additional ITP therapy, while 23 relapsed giving an overall sustained response rate of 10% (26/260). These 26 subjects were all chronic ITP patients who had received an average of 4 (range 2-5) prior therapies. In another study [6], Gonzales et al studied 30 newly diagnosed ITP, 30 persistent ITP and 160 chronic ITP subjects for treatment free response after discontinuing eltrombopag.Five newly diagnosed (16.6%), four persistent (13.3%) and thirty-five chronic (22%) ITP were able to achieve off therapy response of ≥ 6 months.In another study of adult ITP treated with romiplostim by Newland et al, 75 subjects with ITP of ≤ 6 months and who had  received romiplostim for ≤ 12 months have treatment discontinued and treatment-free durable responses (platelet counts >50×10⁹/L lasting at least six months) was observed in 23 (32%) subjects [7].

Zhang et al [8] conducteda pilot study to evaluate whether a 12-week course of eltrombopag plus 1-3 courses of pulsed dexamethasone as first line therapy for ITP patients could increase the proportion of patients with platelets >50×10⁹/Loff therapyat 6 months. Eligible subjects had confirmed ITP and platelet counts < 30×10⁹/L or platelet counts < 50×10⁹/Land significant bleeding symptoms (WHO bleeding scale 2 or above). Patients must have no prior ITP treatment. Treatment consisted of eltrombopag 25-75 mg daily according to platelet response for 12 weeks plus pulsed dexamethasone, 40 mg daily for 4 consecutive days every 4 weeksfor 1-3 courses. Fiftysubjects with primary ITPwere successfully enrolled from November 2014 to January 2019.In an intention to treat analysis, 26/50 (52%) had achieved the primary endpoint of platelet counts > 50×10⁹/L for more than 6 months after discontinuation of treatment. Three subjects had withdrawn consent before starting treatment, one was withdrawn because of protocol violations and one subject subsequently was diagnosed amegakaryocytic thrombocytopenia. Excluding these 5 subjects, the treatment free response rate would be 57.7%. Among these 26 patients, 17 had maintained platelet count over 100 x10⁹/L for longer than 18 months (mean 41.1, range 19-55 months). Age, sex, clinical features, average daily dose of eltrombopag and number of courses of dexamethasone of these 17 subjects were not significantly different from the rest of the subjects. Among remaining 9 subjects, three had relapsed with satisfactory response to 4- week course of eltrombopag plus pulsed dexamethasone. The remaining six had platelet counts fluctuating between 40-60x×10⁹/L without any significant bleeding symptoms or further ITP treatment (manuscript submitted). Even though this was only a single arm study, the treatment free response rate was the highest reported so far. Also, the mean duration of the treatment free response was also among the longest reported. These data suggested that 12-week of eltrombopag plus dexamethasone as first line treatment may result in prolonged response off therapy in nearly half of ITP subjects.

Treatment free prolonged response can be achieved in 10-50 % of ITP subjects treated with TPORAs. We suggested that ITP subjects who have achieved a steady platelet counts of > 50x x 10⁹/L with minimal bleeding symptoms after 3 or more months of treatment with a stable dose of should have gradually taperingof the TPORAs every 2 weeks the minimum amount required to maintain an adequate platelet count for minimal bleeding symptoms. In 10-30% of ITP subjects, the TPORAs can be tapered off to achieve treatment free prolonged response. In treatment naïve ITP subjects, eltrombopag plus pulsed dexamethasone is a promising treatment choice for achieving treatment free response.

References

1. Amgen INplate(2017) romiplostim. Thousand Oaks, CA: Amgen.
2. Glaxo-Smith-Kline Promacta (2017) eltrombopag. NC: Research Triangle Park.
3. Pharmaceuticals D Doptelet (2018) avatrombopa. tablets: US prescribing information.
4. Mahevas M, Fain O, Ebbo M, et al. (2014) The temporary use of thrombopoietin-receptor agonists may induce a prolonged remission in adult chronic immune thrombocytopenia. Results of a French observational study. Br J Haematol.165:865–869.
5. Gonzalez-Lopez TJ, Pascual C, Alvarez-Roman MT, et al. (2015) Successful discontinuation of eltrombopag after complete remission in patients with primary immune thrombocytopenia. Am J Hematol90: E40–43.
6. Gonzalez-Lopez TJ, Fernandez-Fuertes F, Hernandez-Rivas JA, et al.(2019)  Efficacy and safeof eltrombopag in persistent and newly diagnosed ITP in clinical practice. International Journal of Hematology106:508-516.
7. Newland A, Godeau B, Priego V, et al. (2016) Remission and platelet responses with romiplostim in primary immune thrombocytopenia: final results from a phase 2 study. Br J Haematol172:262–273.
8. Zhang L, Zhang M, DuX, Cheng Y, and Cheng G (2020) Safety and efficacy of eltrombopag plus pulsed dexamethasone as first‐line therapy for immune thrombocytopenia. British Journal of Hematology.

DOI: 10.31038/JCRM.2020323

Keywords

Plastic surgery, scars, scar models, wound, wound healing, review

Editorial

Scarring is a cosmetically undesirable outcome of wound healing. Modern scar research investigates the processes behind scarring and, more importantly, the efficacy of medications and procedures. The wide variety of scar models ranges from animal models – red duroc pigs, athymic mice, rabbit ears – to virtual “in silico” models, to human cell models of varying complexity in regards to mimicking the true in vivo environment.  Current volunteer or patient human models of scarring are limited by ethical concerns regarding purposeful wounding, difficulty controlling factors such as location, scar size, and scar orientation in existing scars, and, in general, the challenges of recruitment for a human scar study.

The Northwestern Abdominoplasty Scar Model was introduced in 2016 and touted to be a streamlined and effective modern in vivo human scar model [1]. To better characterize the role of the model in current scar research, Hsieh and colleaguespublished a summary article comparing the Northwestern Abdominoplasty Scar Model to the existing gamut of scar models, especially new developments in animal models [2].

The Northwestern Abdominoplasty Scar Model comprises of patients undergoing elective abdominoplasty. After a detailed and thorough informed consent process, patients who agree are scarred or wounded in the pannus using local anesthesia in the clinic. As the pannus is typically large, 20 2-cm full-thickness horizontal wounds are able to be produced in a grid fashion. The wounds are created to mirror each other in location and, as a result, one side can test the trial intervention while the other serves as the control. Outcome measures include visual assessment of scarring with pictures and histological and biochemical analysis through biopsy. Weeks to months after the end of the study, the pannus removed as a part of the abdominoplasty.

The main benefit of the Northwestern Abdominoplasty scar model, compared to animal, in silico, or in vitro models is that the model utilizes scarring in humans. Compared to other volunteer or patient in vivo models, the Northwestern Abdominoplasty Scar Model overcomes the primary limitations of 1) control in wound characteristics, 2) patient recruitment and 3) ethical considerations surrounding purposeful wounding.

Factors such as the size, number, and types of wounds created can be altered according to the investigator’s specifications. Multiple interventions at various doses can be tested using the same patient. Since the abdominoplasty is a fairly common cosmetic procedure and that the procedure is cost-free should a patient choose to participate, recruitment is streamlined, and since each patient can be wounded multiple times, studies can require fewer patients. Ethical hurdles of purposeful scarring and potentially leaving patients with wounds or scars are bypassed given that the pannus is excised during the abdominoplasty.

The primary limitation of the model rests in performing a detailed informed consent process and emphasizing to the patient that should they opt out of the study, the scars created will remain. Another major limitation is that only low-tension, ventral abdominal wounds can be studied. It is difficult to assess pathological scarring in this model, as patients who present for elective abdominoplasty may or may not scar well, and patients with history of keloids are specifically excluded out of concern for poor scarring. Other limitations include efficacy in assessing deep, vertical, or curved wounds, as only shallow, linear scars have been studied using this model. Further studies of this model will characterize its role in studying these wounds, especially given that tension varies depending on the orientation. Overall, the Northwestern Abdominoplasty Model offers several critical improvements over existing in vivo human models, but will encourage greater interest in in vivo human model development, with potential utilization of cosmetic surgeries in other areas of the body for scar research.

References

1. Lanier ST, Liu J, Chavez-Munoz C, Mustoe TA, Galiano RD (2016) The Northwestern Abdominoplasty Scar Model: A Novel Human Model for Scar Research and Therapeutics. PlastReconstrSurg Glob Open. 4(9):e867. [crossref]
2. Ji-Cheng Hsieh, BA; Chitang J. Joshi, MBBS MS; Rou Wan, MD; Robert D. Galiano, MD, FACS (2020) The Northwestern Abdominoplasty Scar Model: A Tool for High-throughput Assessment of Scar Therapeutics. Advances in Wound Care.00(00):0-0 [c rossref]

DOI: 10.31038/JCRM.2020322

Abstract

With advances in cancer treatment and intervention, people are living as cancer survivors longer than ever before. This comes with a host of long term and late effects of treatment. Therefore, it is clear that additional ways to care for these patients are warranted. Exercise intervention has shown to be a safe and effective way to mitigate some of the side-effects of cancer treatment. The Maple Tree Cancer Alliance is a non-profit organization that provides free supervised, individualized exercise programming for cancer survivors. What follows is the patient journey through this program, highlighting key components in an attempt to advocate for exercise to become a part of the standard of care in cancer.

Introduction

At present, cancer survivorship is at an all time high. People are living longer as cancer survivors than at any other point in history. Mortality rates from cancer are the lowest they have ever been [1]. This is all very positive news in the war against cancer.

However, there is a downside to this increase in survivorship. With more people living longer as cancer survivors, this means that more people are experiencing the side effects associated with treatment, including fatigue, nausea, cardiac abnormalities, lymphedema and more [2]. Though treatment is beneficial for fighting against the cancer, it can bring forth many different side-effects and hardships later in the life of a cancer survivor. More than 98% of patients experience these effects [3], sometimes even years after cessation of treatment. With increases in survivorship the care that is needed is always advancing [4].

We assert, and decades of research would support, that exercise is a safe and valid measure to mitigate these side effects [6-8]. Numerous studies and professional organizations recognize its safety and efficacy at any point along the cancer trajectory [6, 8].

However, despite these benefits, less than 5% of cancer patients exercise during cancer treatment, nationally [3]. Maple Tree Cancer Alliance is a non-profit organization that was founded in 2011 to try and increase this number, and encourage more patients to embrace the idea of exercise during treatment. Our nationally recognized model has been widely embraced by the medical community and has changed the lives of thousands of patients across the country. We are hoping to use our platform to advocate for exercise to become a part of the standard of care in cancer, as well as expand insurance coverage for these life-enhancing services [9,10].

To do so, we have established a unique-4 phase approach to cancer rehabilitation. Depending on where patients are in their treatment journey when they begin with Maple Tree, we classify them into one of four phases. Each phase is 12-weeks long, with the exception of phase 4, which is ongoing. A brief summary of this phase system is outlined below:

The purpose of this article is to present the patient journey through our program, including referral systems, assessment, exercise programming, and data analysis. Our hope is that through sharing this information, common questions may  be  answered  allowing  for more standardized exercise programs may be implemented into cancer centers throughout the country.

Patient Referral Systems

Patients connect with Maple Tree Cancer Alliance through several channels. Approximately 5-10% of our patients come through word-of-mouth. They may hear through friends, family and/or other patients, social media, health fairs, or other events that Maple Tree Cancer Alliance takes part in.

The vast majority of our patients are referred by their medical team member, which may include, but not exclude Oncologists, Medical Assistants, Physicians Assistants, Primary Care Physicians, and Physical Therapists.

It is important to note, regardless of how a patient initiates contact with us, a physician’s clearance release form is required to partake in our program. This clearance form will make sure that the patient is medically cleared to participate in an exercise program, and verify any restrictions or modifications that we would need to adhere to.

Initial Patient Appointment

After obtaining a medical release form from the physician, the initial appointment is scheduled. During this initial appointment, our team takes time to discuss the individualized aspects of our training, how the phases/intensities are structured, and go over paperwork.

Paperwork that is reviewed during the initial appointment are as follows:

a. Liability waiver– The patient understands  the  adherent  risk of injury when completing an exercise program. Our organization goes above and beyond to create the safest working environment, but the possibility for injury exists. This form prevents liable against Maple Tree in the event an injury does occur.

b. Attendance policy– This form informs our patients of our attendance, no-show, and cancellation policies.

c. Media release waiver– This optional form allows us to share on our social media platforms the success of patients as they participate in our program.

d. Physician release form– Part of the required paperwork before starting. Gives us medical clearance to work with the patient and allows us to understand any restrictions.

e. Health History– The health history form is used as a means to assess risk, not for diagnostic purposes. This form helps  us understand any current or previous condition that may impact a patient’s exercise prescription and programming.

i. Patient contact form– Basic patient information including phone number, email and address.

ii. Pre-existing conditions– Any co-morbidity that may impact the patients individualized plan that we create for them which include but is not limited to issues such as high blood pressure, diabetes, high cholesterol, thyroid problems, etc.

iii. Medications/prior surgeries (non-cancer related)- Helps us understand their medications and prior surgeries that are non-cancer related that may impact their program or certain aspects (such as measuring heart rate during exercise)

iv. Cancer history– everything about their cancer is disclosed on this page including treatments, surgeries, and any planned actions made by their physician.

v. General questions– On this page we can learn more about their concerns about their health and regarding exercise and their current exercise habits (this helps us understand the mindset they may have).

Comprehensive Fitness Assessment

Upon completing the review of paperwork, the patient undergoes a comprehensive fitness assessment. The first step to the fitness assessment is measuring patient vital signs, including weight, height, blood pressure, oxygen saturation levels, heart rate, and body mass index. Next, the Exercise Oncology Instructor performs a complete posture evaluation on the patient. For this assessment, head to toe issues regarding postural deviations are checked and noted. Third, body composition is measured via skinfold analysis. Muscular strength is measured via hand grip dynamometer. Cardiorespiratory fitness testing is completed using the treadmill protocol created by the Rocky Mountain Cancer Rehabilitation Institute. Muscular endurance testing involves a modified sit up test. Flexibility testing is completed with the modified sit and reach assessment.

Exercise Prescription

Once the fitness assessment is completed and scores are calculated, the exercise prescription is then completed by the instructor administering the testing. The exercise prescription serves as a 12- week outline of the exercise program. It includes goals that are unique to the patient with progress that can be easily obtained. We also give the patient a rating based on well-established norms by the American College of Sports Medicine and Senior Fitness Testing Protocol.

Depending on where the patient is in their treatment regimen, they are grouped into one of the phases outlined in Table 1. Each phase of our program is designed to last 12-weeks. In order to protect immunity, exercise intensity levels increase as the patient moves through each phase. Initially, Phase 1 begins at an exercise intensity of approximately 30-45%. However, when the patient reaches Phase 3, they are able to tolerate exercise intensities between 50-85%.

The intensity is calculated via the Karvonen Method and is monitored throughout the exercise program with an activity tracker. In cases where treatments or medications may blunt heart rate response, we utilize the Borg Rating of Perceived Exertion scale.

Although the 12-week plan maps out each week’s exercise intensity, each day a patient comes in is subject to change based on how the patient feels.

Exercise Programming

After review of the Fitness Assessment and Exercise Prescription, patients are assigned an Exercise Oncology Instructor to work with. This Exercise Oncology Instructor will be responsible for the execution of the Exercise Programming phase of the patient journey. Each patient is allowed one session per week with their Exercise Oncology Instructor. All exercise programming is individualized and tailored to the patient’s specific strengths, weaknesses, and goals set forth in the Exercise Prescription phase.

Every exercise program includes an aerobic component, strength training, and flexibility, adhering to ACSM’s guidelines for exercise oncology [6-11]. Tables 2-4 detail these recommendations.

As a general rule, we do not address a specific time frame for exercise progression (i.e. after one month increase treadmill duration to XX…). Rather, we focus on increasing exercise duration and frequency first, before increasing exercise intensity.

The role of the Maple Tree Cancer Alliance Exercise Oncology Instructor is to create a safe and effective protocol to help the patient improve their quality of life. The typical progression of strength training includes beginning with range-of-motion movements so the prescribed exercises are performed with optimal biomechanical form. In order to do this, the Exercise Oncology Instructor must perform manual muscle testing in different planes and take notes on where compensation occurs, or range-of-motion is sub-optimal.

Once optimal range-of-motion can be performed without any pain/negative symptoms, then the patient is assigned exercises to strengthen the motor pathway while maintaining the joint’s range-of- motion. Trainer should monitor for pain, pulling, stiffness, fullness, radiating pain, sharp pain, or dull pain during the exercise. When the patient has a well-established weekly exercise habit that allows them to no longer be trained as a “sedentary” individual, the trainer may safely increase exercise intensity.

The ultimate goal of each session is to have the patient feeling better than when they came in. Of course, there will be days when the patient may not be feeling well. On those days, and it is important to modify the workout, as needed.

Follow-up Assessments

At the completion of each 12-week phase, a follow-up assessment is performed. The goal of the follow-up assessment is to see how   the patient has progressed in each area of fitness. Each test that was performed in the original fitness assessment is  conducted  again. Any changes in performance, whether positive or negative, is noted. New normative values are obtained, and exercise intensity is changed for the new 12-week Phase Plan, accordingly. The patient is given a Certificate of Phase Completion to celebrate this milestone.

Reporting to Physicians

All patient metrics are stored in a master database which can be used to generate reports and forms. These reports and forms showcase:

• Patient treatment types

• Commonly served patient populations

• Age

• Gender

• Ethnicity

• Cancer type

• Patient progress across all phases completed

• Communication is  important  between  the  site-coordinators and the medical professionals. It is our goal to keep an open door of communication with the medical team. Specifically, we communicate when:

• A referred patient begins the Maple Tree Cancer Alliance Exercise Oncology program.

• The medical records for the patient have been received.

• The referred patient completes a Phase of our program, and we share the results from the re-assessment.

The referred patient leaves the Maple Tree Exercise Oncology program. Patients may exit the program for various reasons, the most commonly stated reasons include cancer remission, and the patient feels they have adapted to the health modifications that we have taught them, and they are self- sufficient regarding taking care of their own health.

Conclusion

With cancer survivorship increasing, the promotion of care after treatment is continually evolving. Patients and physicians are looking for ways to cope with side effects of cancer and cancer treatments. Several studies have shown that exercise is not only safe for people at several points along the cancer spectrum but can also aid in fighting against some of these side effects.

The Maple Tree Cancer Alliance has developed a phase program that is able to reach people at every part of their cancer journey so that they may start their journey with exercise intervention. The phase program at the MTCA is created with the guidelines set out  by the American College of Sports Medicine. Prior to starting an exercise program, the patient will go through a thorough screening and fitness assessment in order for their trainer to put together a personalized program. If the patient completes their phase, they have the opportunity to move up in their phases to increase their exercise capacity and possible physical function. The goal is that each patient will have the opportunity to move through each phase of our program on their way to increasing their exercise and physical activity habits while also relieving some of their side effects related to their diagnosis and treatment.

References

1. American Cancer Society. Cancer Facts and Figures 2020. Atlanta: American Cancer Society; 2020.
2. National Cancer Institute. Side Effects of Cancer Treatment. 2020.
3. Smith SR, Zheng JY (2017) The Intersection of Oncology Prognosis and Cancer Rehabilitation. Curr Phys Med Rehabil Rep 5:46-54. [crossref]
4. Shapiro, CL (2018) Cancer Survivorship. The New England Journal of Medicine. 379: 2438-2450. [crossref]
5. Smith SR, Zheng JY (2017) The Intersection of Oncology Prognosis and Cancer Rehabilitation. Curr Phys Med Rehabil Rep 5:46-54. [crossref]
6. Campbell KL, Winters-Stone K, Wiskemann J. et al. (2019) Exercise Guidelines  for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Medicine and Science in Sport and Exercise. [crossref]
7. Jones LW, Eves N, Mackey JR, et al. (2007) Safety and feasibility of cardiopulmonary exercise testing in patients with advanced cancer. Lung Cancer. 2:225-232. [crossref]
8. Cormie P, Newton R, Spry N, et al. (2013) Safety and efficacy of resistance exercise in prostate cancer patients with bone metastasis. Prostate Cancer and Prostatic Disease. 16: 328-335. [crossref]
9. Maple Tree Cancer Alliance: Services. https://www.mapletreecanceralliance.org/services/
10. Wonders, K. Ondreka, D (2018) Wise, R. Supervised, individualized exercise mitigates symptom severity during cancer treatment. J Adeno & Osteo. 3(1):1-5.
11. Irwin M. ACSM’s Guide to Exercise and Cancer Survivorship. Human Kinetics. 2012.