The eSMART study protocol : a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer

Introduction While some evidence exists that real-time remote symptom monitoring devices can decrease morbidity and prevent unplanned admissions in oncology patients, overall, these studies have significant methodological weaknesses. The electronic Symptom Management using the Advanced Symptom Management System (ASyMS) Remote Technology (eSMART) study is designed to specifically address these weaknesses with an appropriately powered, repeated-measures, parallel-group stratified randomised controlled trial of oncology patients. Methods and analysis A total of 1108 patients scheduled to commence first-line chemotherapy (CTX) for breast, colorectal or haematological cancer will be recruited from multiple sites across five European countries.Patients will be randomised (1:1) to the ASyMS intervention (intervention group) or to standard care currently available at each site (control group). Patients in the control and intervention groups will complete a demographic and clinical questionnaire, as well as a set of valid and reliable electronic patient-reported outcome measures at enrolment, after each of their CTX cycles (up to a maximum of six cycles) and at 3, 6, 9 and 12 months after completion of their sixth cycle of CTX. Outcomes that will be assessed include symptom burden (primary outcome), quality of life, supportive care needs, anxiety, self-care self-efficacy, work limitations and cost effectiveness and, from a health professional perspective, changes in clinical practice (secondary outcomes). Ethics and dissemination Ethical approval will be obtained prior to the implementation of all major study amendments. Applications will be submitted to all of the ethics committees that granted initial approval.eSMART received approval from the relevant ethics committees at all of the clinical sites across the five participating countries. In collaboration with the European Cancer Patient Coalition (ECPC), the trial results will be disseminated through publications in scientific journals, presentations at international conferences, and postings on the eSMART website and other relevant clinician and consumer websites; establishment of an eSMART website (www.esmartproject.eu) with publicly accessible general information; creation of an eSMART Twitter Handle, and production of a toolkit for implementing/utilising the ASyMS technology in a variety of clinical practices and other transferable health care contexts. Trial registration number NCT02356081

Proceedings of Patient Reported Outcome Measure’s (PROMs) Conference Oxford 2017: Advances in Patient Reported Outcomes Research

A33-Effects of Out-of-Pocket (OOP) Payments and Financial Distress on Quality of Life (QoL) of People with Parkinson’s (PwP) and their Carer

Poisoning from a dietary supplement administered during hospitalization

Increasing numbers of persons use dietary supplements (DS). Patients who believe in the effectiveness of DS may continue to take them on admission to a health care facility. We present the case of a child who received a DS on a daily basis as an outpatient, continued its use after admission to the hospital, and became poisoned by it during his hospitalization

Enabling Symptom Self-management Via Ese of an Electronic Patient-reported Outcomes (ePRO) System to Increase Self-efficacy of Patients with Cancer Receiving Active Chemotherapy Treatment

Background: In recent years, the shift in cancer services from traditional tertiary care to care delivered within communities has increased the need for patients to engage in self-care activities in order to prevent or reduce the severity of numerous and complex-side effects (McCorkle et al., 2011) and make important health decisions when at home in the absence of clinicians (Butow et al., 2012). The actual degree of engagement in self-management may be dependent on patients’ perceived competence or self-efficacy to perform such activities (Fenlon et al., 2015). Self-efficacy has been defined as “a person’s belief to execute courses of action required to deal with a prospective situation” (Bandura, 1977, 2001). One’s beliefs in their capability to successfully manage tasks and consequently influence situations that impact their lives constitutes a central part of human agency, and can be influenced by performance accomplishments (Bandura, 1989, 2001). Whilst self-efficacy can enable engagement in self-management, actual participation in self-management activities can further increase one’s perceived ability to undertake such activities; it is thus obvious that a bi-directional association between self-management and self-efficacy exists. Supporting a shift in clinical practice with innovative technological systems affords a solution to the increasing demands placed on acute care by enabling the delivery of care in the home and community setting (Basch et al., 2011; Carpenter et al., 2008). Such remote monitoring systems facilitate the provision of clear lines of real-time communication between patients and their health care providers (Basch et al., 2011), and can deliver organised self-management advice tailored to the individual’s clinical characteristics and severity/distress of symptoms of anti-cancer treatment. Aim(s): Funded by the European Union (FP7 programme), a multi-centre European project (the eSMART study) has been designed to investigate the effects of an electronic patient-reported outcomes (ePRO) system, the Advanced Symptom Management System (ASyMS), on patient outcomes including improvement in self-efficacy, symptom management, supportive care needs, psychological status, work presenteeism, and well-being; health system costs; and the current clinical practice. The primary aim of eSMART is to evaluate the short and long term impact of the ASyMS technology on patient reported outcomes in people with breast cancer, colorectal cancer or haematological malignancies receiving first-line chemotherapy. In addition, eSMART will evaluate the cost-benefit of remote patient-monitoring and changes in clinical practice as a result of the application of the ASyMS intervention in different European healthcare settings. The study is currently recruiting patients, thus no data will be available for presentation. This presentation will nonetheless aim to present and discuss the hypothesis that provision of symptom self-management advice may be an important mechanism to improve patient self-efficacy, which may establish a self-sustained cycle where self-care advice provision enables patient self-efficacy and this in turn further increases patient involvement in self-management that can ultimately lead to improved patient outcomes. Method(s)/Results: The current study has been informed by the Medical Research Council Complex Interventions Framework (Anderson, 2008; Craig and Petticrew, 2012; Mackenzie et al., 2010), and the Holistic Framework to improve the Uptake and Impact of e-Health Technologies (van Gemert-Pijnen et al., 2011). The eSMART programme of work comprises two parts that will take place over a period of five years. The first part consists of preparatory work to refine the ASyMS intervention for use in a multi-national context, and concludes with a feasibility testing period to establish the technological readiness of the system prior to its use in the second part. The second part will employ a repeated-measures, parallel-group, stratified randomised controlled trial methodology to demonstrate the effects of the ASyMS intervention in supporting patients who receive chemotherapy treatment through individualised symptom management. The second part will test the short- (i.e. during the treatment phase) and long-term effects (i.e. at one-year follow-up) of the ASyMS intervention versus standard care across the participating countries (Austria, Greece, Ireland, Norway and the UK). The ASyMS intervention comprises use of a mobile phone (i.e. ASyMS patient handset) and a tympanic thermometer. The patient handset will enable participants on the intervention group to enter symptom/temperature data on a dedicated, electronic symptom questionnaire daily and whenever they feel unwell. Upon successful submission of their data, patients will immediately receive automated, evidence-based self-care advice based on their symptom reports. Patients will also have access to a self-care library, symptom graphs (detailing trends in individual symptoms experienced) and contact numbers of care teams and patient support organisations in their country, available within the ASyMS patient handset. Via dedicated tablet PCs, all participants will complete an electronic version of the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-Cancer) (Wolf et al., 2005) at baseline; after each CTx; and 3, 6, 9 and 12 months post-chemotherapy treatment. The CASE-Cancer is a validated, 12-item measure that yields scores on three factors: understanding and participating in care, maintaining a positive attitude, and seeking and obtaining information. In accordance with latest recommendations for pragmatic research in healthcare (Oakley et al., 2006; Treweek and Zwarenstein, 2009), the longitudinal nature of the trial will aid to establish sustainability of intervention effects and further stress its benefits when compared to standard care. Conclusions: This anticipatory model of care supports symptom management within the patient’s home, where the early toxicities of chemotherapy can be managed, utilising self-care and local community services. This model is also expected to contribute to the health literacy of patients with cancer in relation to early identification, report and self-management of their most common symptoms. As part of the project’s objectives, we will aim to show improved self-efficacy (as shown by statistically significantly higher self-efficacy scores) during active chemotherapy for breast cancer, colorectal cancer, or haematological malignancies, and/or at one-year follow-up. It is hoped that an enhanced self-efficacy (evidenced by patients’ greater understanding and participation in care, positive attitude, and engagement in seeking health-related information) will in turn enable a smoother rehabilitation process for patients in the post-treatment survivorship period and beyond. EU FP7 Programme Grant agreement No. 602289. Trial registration identifier (clinicaltrials.gov) NCT02356081

Enabling Symptom Self-management Via Ese of an Electronic Patient-reported Outcomes (ePRO) System to Increase Self-efficacy of Patients with Cancer Receiving Active Chemotherapy Treatment

Background: In recent years, the shift in cancer services from traditional tertiary care to care delivered within communities has increased the need for patients to engage in self-care activities in order to prevent or reduce the severity of numerous and complex-side effects (McCorkle et al., 2011) and make important health decisions when at home in the absence of clinicians (Butow et al., 2012). The actual degree of engagement in self-management may be dependent on patients’ perceived competence or self-efficacy to perform such activities (Fenlon et al., 2015). Self-efficacy has been defined as “a person’s belief to execute courses of action required to deal with a prospective situation” (Bandura, 1977, 2001). One’s beliefs in their capability to successfully manage tasks and consequently influence situations that impact their lives constitutes a central part of human agency, and can be influenced by performance accomplishments (Bandura, 1989, 2001). Whilst self-efficacy can enable engagement in self-management, actual participation in self-management activities can further increase one’s perceived ability to undertake such activities; it is thus obvious that a bi-directional association between self-management and self-efficacy exists. Supporting a shift in clinical practice with innovative technological systems affords a solution to the increasing demands placed on acute care by enabling the delivery of care in the home and community setting (Basch et al., 2011; Carpenter et al., 2008). Such remote monitoring systems facilitate the provision of clear lines of real-time communication between patients and their health care providers (Basch et al., 2011), and can deliver organised self-management advice tailored to the individual’s clinical characteristics and severity/distress of symptoms of anti-cancer treatment. Aim(s): Funded by the European Union (FP7 programme), a multi-centre European project (the eSMART study) has been designed to investigate the effects of an electronic patient-reported outcomes (ePRO) system, the Advanced Symptom Management System (ASyMS), on patient outcomes including improvement in self-efficacy, symptom management, supportive care needs, psychological status, work presenteeism, and well-being; health system costs; and the current clinical practice. The primary aim of eSMART is to evaluate the short and long term impact of the ASyMS technology on patient reported outcomes in people with breast cancer, colorectal cancer or haematological malignancies receiving first-line chemotherapy. In addition, eSMART will evaluate the cost-benefit of remote patient-monitoring and changes in clinical practice as a result of the application of the ASyMS intervention in different European healthcare settings. The study is currently recruiting patients, thus no data will be available for presentation. This presentation will nonetheless aim to present and discuss the hypothesis that provision of symptom self-management advice may be an important mechanism to improve patient self-efficacy, which may establish a self-sustained cycle where self-care advice provision enables patient self-efficacy and this in turn further increases patient involvement in self-management that can ultimately lead to improved patient outcomes. Method(s)/Results: The current study has been informed by the Medical Research Council Complex Interventions Framework (Anderson, 2008; Craig and Petticrew, 2012; Mackenzie et al., 2010), and the Holistic Framework to improve the Uptake and Impact of e-Health Technologies (van Gemert-Pijnen et al., 2011). The eSMART programme of work comprises two parts that will take place over a period of five years. The first part consists of preparatory work to refine the ASyMS intervention for use in a multi-national context, and concludes with a feasibility testing period to establish the technological readiness of the system prior to its use in the second part. The second part will employ a repeated-measures, parallel-group, stratified randomised controlled trial methodology to demonstrate the effects of the ASyMS intervention in supporting patients who receive chemotherapy treatment through individualised symptom management. The second part will test the short- (i.e. during the treatment phase) and long-term effects (i.e. at one-year follow-up) of the ASyMS intervention versus standard care across the participating countries (Austria, Greece, Ireland, Norway and the UK). The ASyMS intervention comprises use of a mobile phone (i.e. ASyMS patient handset) and a tympanic thermometer. The patient handset will enable participants on the intervention group to enter symptom/temperature data on a dedicated, electronic symptom questionnaire daily and whenever they feel unwell. Upon successful submission of their data, patients will immediately receive automated, evidence-based self-care advice based on their symptom reports. Patients will also have access to a self-care library, symptom graphs (detailing trends in individual symptoms experienced) and contact numbers of care teams and patient support organisations in their country, available within the ASyMS patient handset. Via dedicated tablet PCs, all participants will complete an electronic version of the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-Cancer) (Wolf et al., 2005) at baseline; after each CTx; and 3, 6, 9 and 12 months post-chemotherapy treatment. The CASE-Cancer is a validated, 12-item measure that yields scores on three factors: understanding and participating in care, maintaining a positive attitude, and seeking and obtaining information. In accordance with latest recommendations for pragmatic research in healthcare (Oakley et al., 2006; Treweek and Zwarenstein, 2009), the longitudinal nature of the trial will aid to establish sustainability of intervention effects and further stress its benefits when compared to standard care. Conclusions: This anticipatory model of care supports symptom management within the patient’s home, where the early toxicities of chemotherapy can be managed, utilising self-care and local community services. This model is also expected to contribute to the health literacy of patients with cancer in relation to early identification, report and self-management of their most common symptoms. As part of the project’s objectives, we will aim to show improved self-efficacy (as shown by statistically significantly higher self-efficacy scores) during active chemotherapy for breast cancer, colorectal cancer, or haematological malignancies, and/or at one-year follow-up. It is hoped that an enhanced self-efficacy (evidenced by patients’ greater understanding and participation in care, positive attitude, and engagement in seeking health-related information) will in turn enable a smoother rehabilitation process for patients in the post-treatment survivorship period and beyond. EU FP7 Programme Grant agreement No. 602289. Trial registration identifier (clinicaltrials.gov) NCT02356081

The eSMART study protocol: a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer

Abstract Introduction While some evidence exists that real-time remote symptom monitoring devices can decrease morbidity and prevent unplanned admissions in oncology patients, overall, these studies have significant methodological weaknesses. The electronic Symptom Management using the Advanced Symptom Management System (ASyMS) Remote Technology (eSMART) study is designed to specifically address these weaknesses with an appropriately powered, repeated-measures, parallel-group stratified randomised controlled trial of oncology patients. Methods and analysis A total of 1108 patients scheduled to commence first-line chemotherapy (CTX) for breast, colorectal or haematological cancer will be recruited from multiple sites across five European countries. Patients will be randomised (1:1) to the ASyMS intervention (intervention group) or to standard care currently available at each site (control group). Patients in the control and intervention groups will complete a demographic and clinical questionnaire, as well as a set of valid and reliable electronic patient-reported outcome measures at enrolment, after each of their CTX cycles (up to a maximum of six cycles) and at 3, 6, 9 and 12 months after completion of their sixth cycle of CTX. Outcomes that will be assessed include symptom burden (primary outcome), quality of life, supportive care needs, anxiety, self-care self-efficacy, work limitations and cost effectiveness and, from a health professional perspective, changes in clinical practice (secondary outcomes). Ethics and dissemination Ethical approval will be obtained prior to the implementation of all major study amendments. Applications will be submitted to all of the ethics committees that granted initial approval. eSMART received approval from the relevant ethics committees at all of the clinical sites across the five participating countries. In collaboration with the European Cancer Patient Coalition (ECPC), the trial results will be disseminated through publications in scientific journals, presentations at international conferences, and postings on the eSMART website and other relevant clinician and consumer websites; establishment of an eSMART website (www.esmartproject.eu) with publicly accessible general information; creation of an eSMART Twitter Handle, and production of a toolkit for implementing/utilising the ASyMS technology in a variety of clinical practices and other transferable health care contexts. Trial registration number NCT02356081. This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ http://dx.doi.org/10.1136/bmjopen-2016-01501

Critical Issues in the Identification of Gifted Students With Co-Existing Disabilities: The Twice-Exceptional

En: SAGE Open, July-September, pp. 1–16Federal law ensures all students with disabilities the right to a Free, Appropriate Public Education (FAPE). However, current policies governing a student’s eligibility for services may contribute to the underidentification of gifted children with co-existing disabilities—the Twice-Exceptional. The emphasis on below-grade-level (or lower) performance, without regard to ability or potential weaknesses, misses twice-exceptional students. Those who perform at grade level, by using advanced conceptual abilities and hard work to compensate, may still require interventions and accommodations to manage increasing educational demands. Otherwise, college and even high school graduation may be out of reach. This article reviews changing laws and policies, explores case studies of twice-exceptional students missed, and examines the diagnosis of twice-exceptionality through comprehensive assessment. Appropriate best practices for the identification of twice-exceptional learners, maintenance of their civil rights, and provision of FAPE are offered for educators, parents, advocates, and legislators as federal, state, and district laws/policies evolve

Critical Issues in the Identification of Gifted Students With Co-Existing Disabilities

Federal law ensures all students with disabilities the right to a Free, Appropriate Public Education (FAPE). However, current policies governing a student’s eligibility for services may contribute to the underidentification of gifted children with co-existing disabilities—the Twice-Exceptional. The emphasis on below-grade-level (or lower) performance, without regard to ability or potential weaknesses, misses twice-exceptional students. Those who perform at grade level, by using advanced conceptual abilities and hard work to compensate, may still require interventions and accommodations to manage increasing educational demands. Otherwise, college and even high school graduation may be out of reach. This article reviews changing laws and policies, explores case studies of twice-exceptional students missed, and examines the diagnosis of twice-exceptionality through comprehensive assessment. Appropriate best practices for the identification of twice-exceptional learners, maintenance of their civil rights, and provision of FAPE are offered for educators, parents, advocates, and legislators as federal, state, and district laws/policies evolve