scholarly journals A Roadmap to Inform Development, Validation and Approval of Digital Mobility Outcomes: The Mobilise-D Approach

2020 ◽  
Vol 4 (1) ◽  
pp. 13-27 ◽  
Author(s):  
Lynn Rochester ◽  
Claudia Mazzà ◽  
Arne Mueller ◽  
Brian Caulfield ◽  
Marie McCarthy ◽  
...  

Health care has had to adapt rapidly to COVID-19, and this in turn has highlighted a pressing need for tools to facilitate remote visits and monitoring. Digital health technology, including body-worn devices, offers a solution using digital outcomes to measure and monitor disease status and provide outcomes meaningful to both patients and health care professionals. Remote monitoring of physical mobility is a prime example, because mobility is among the most advanced modalities that can be assessed digitally and remotely. Loss of mobility is also an important feature of many health conditions, providing a read-out of health as well as a target for intervention. Real-world, continuous digital measures of mobility (digital mobility outcomes or DMOs) provide an opportunity for novel insights into health care conditions complementing existing mobility measures. Accepted and approved DMOs are not yet widely available. The need for large collaborative efforts to tackle the critical steps to adoption is widely recognised. Mobilise-D is an example. It is a multidisciplinary consortium of 34 institutions from academia and industry funded through the European Innovative Medicines Initiative 2 Joint Undertaking. Members of Mobilise-D are collaborating to address the critical steps for DMOs to be adopted in clinical trials and ultimately health care. To achieve this, the consortium has developed a roadmap to inform the development, validation and approval of DMOs in Parkinson’s disease, multiple sclerosis, chronic obstructive pulmonary disease and recovery from proximal femoral fracture. Here we aim to describe the proposed approach and provide a high-level view of the ongoing and planned work of the Mobilise-D consortium. Ultimately, Mobilise-D aims to stimulate widespread adoption of DMOs through the provision of device agnostic software, standards and robust validation in order to bring digital outcomes from concept to use in clinical trials and health care.

2020 ◽  
Vol 26 (4) ◽  
pp. 3184-3200
Author(s):  
Pernilla Sönnerfors ◽  
Karin Wadell ◽  
Ing-Mari Dohrn ◽  
André Nyberg ◽  
Michael Runold ◽  
...  

Technology developments and demand for flexibility in health care and in contact with the health care system are two factors leading to increased use of eHealth solutions. The use of eHealth has been shown to have positive effects in people with chronic obstructive pulmonary disease, but the full potential for this group needs to be explored. Therefore, the aim was to evaluate the feasibility of an eHealth tool used for exercise training and online contacts for people with severe chronic obstructive pulmonary disease. The 10-week intervention included an eHealth tool for exercise training in home environment and regular online contacts, as well as weekly e-rounds for health care professionals. Seven of the nine participants completed the study. The eHealth tool was found to be feasible for e-rounds, exercise training and online contacts. Participants could manage the tool and adhere to training; positive effects were shown, and no adverse events occurred. Technical functions need to be improved.


2015 ◽  
Vol 95 (10) ◽  
pp. 1387-1396 ◽  
Author(s):  
Pat G. Camp ◽  
W. Darlene Reid ◽  
Frank Chung ◽  
Ashley Kirkham ◽  
Dina Brooks ◽  
...  

Background Exercise is recommended for people with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD), yet there is little information to guide safe and effective mobilization and exercise for these patients. Objectives The purpose of this study was to develop a clinical decision-making tool to guide health care professionals in the assessment, prescription, monitoring, and progression of mobilization and therapeutic exercise for patients with AECOPD. Design and Methods A 3-round interdisciplinary Delphi panel identified and selected items based on a preselected consensus of 80%. These items were summarized in a paper-based tool titled Mobilization in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (AECOPD-Mob). Focus groups and questionnaires were subsequently used to conduct a sensibility evaluation of the tool. Results Nine researchers, 13 clinicians, and 7 individuals with COPD identified and approved 110 parameters for safe and effective exercise in AECOPD. These parameters were grouped into 5 categories: (1) “What to Assess Prior to Mobilization,” (2) “When to Consider Not Mobilizing or to Discontinue Mobilization,” (3) “What to Monitor During Mobilization for Patient Safety,” (4) “How to Progress Mobilization to Enhance Effectiveness,” and (5) “What to Confirm Prior to Discharge.” The tool was evaluated in 4 focus groups of 18 health care professionals, 90% of whom reported the tool was easy to use, was concise, and would guide a health care professional who is new to the acute care setting and working with patients with AECOPD. Limitations The tool was developed based on published evidence and expert opinion, so the applicability of the items to patients in all settings cannot be guaranteed. The Delphi panel consisted of health care professionals from Canada, so items may not be generalizable to other jurisdictions. Conclusions The AECOPD-Mob provides practical and concise information on safe and effective exercise for the AECOPD population for use by the new graduate or novice acute care practitioner.


2006 ◽  
Vol 13 (7) ◽  
pp. 362-368 ◽  
Author(s):  
S Costi ◽  
D Brooks ◽  
RS Goldstein

BACKGROUND: Prompt treatment of acute exacerbations (AEs) in chronic obstructive pulmonary disease (COPD) improves quality of life and reduces the use of health care resources. Although patient self-management through an individualized action plan (AP) can help with early initiation of therapy, its use is critically dependent on the patient recognizing the features of an exacerbation.OBJECTIVE: To describe COPD patients’ experiences with AEs, as well as health care professionals’ (HCPs’) attitudes toward the provision of an AP as part of self-management education.METHODS: Thirty-two patients with moderate to severe COPD who recently experienced at least one AE, and 22 HCPs with experience in the management of COPD, were interviewed.RESULTS: The most common symptoms and signs associated with an AE were difficulty breathing (84%), fatigue (81%), cold symptoms (59%), changes in sputum colour (53%) or amount (47%), and cough (44%). The main precipitants identified were environmental triggers (47%), infective agents (31%), excessive activities (25%), emotional factors (16%) and changes in medications (9%). Strategies for dyspnea relief included increasing medications (72%), resting (56%), avoiding exposure to environmental triggers (41%) and performing breathing exercises (31%). Patients supported the use of an AP and recommended that it be individualized for symptoms and triggers, and that it should also include strategies for addressing anxiety and depression. HCPs also supported the use of an individualized AP and recommended that it be regularly revisited, depending on the patient’s disease severity.CONCLUSIONS: Patients’ experiences with AEs do not always conform to a standard medical definition. Therefore, an understanding of their experience is of value in the design of an individualized AP. HCPs support the use of an AP that emphasizes self-management of exacerbations as well as general COPD management.


2017 ◽  
Author(s):  
Mark W Orme ◽  
Amie E Weedon ◽  
Paula M Saukko ◽  
Dale W Esliger ◽  
Mike D Morgan ◽  
...  

BACKGROUND Targeting sedentary time post exacerbation may be more relevant than targeting structured exercise for individuals with chronic obstructive pulmonary disease. Focusing interventions on sitting less and moving more after an exacerbation may act as a stepping stone to increase uptake to pulmonary rehabilitation. OBJECTIVE The aim of this paper was to conduct a randomized trial examining trial feasibility and the acceptability of an education and self-monitoring intervention using wearable technology to reduce sedentary behavior for individuals with chronic obstructive pulmonary disease admitted to hospital for an acute exacerbation. METHODS Participants were recruited and randomized in hospital into 3 groups, with the intervention lasting 2 weeks post discharge. The Education group received verbal and written information about reducing their time in sedentary behavior, sitting face-to-face with a study researcher. The Education+Feedback group received the same education component along with real-time feedback on their sitting time, stand-ups, and steps at home through a waist-worn inclinometer linked to an app. Patients were shown how to use the technology by the same study researcher. The inclinometer also provided vibration prompts to encourage movement at patient-defined intervals of time. Patients and health care professionals involved in chronic obstructive pulmonary disease exacerbation care were interviewed to investigate trial feasibility and acceptability of trial design and methods. Main quantitative outcomes of trial feasibility were eligibility, uptake, and retention, and for acceptability, were behavioral responses to the vibration prompts. RESULTS In total, 111 patients were approached with 33 patients recruited (11 Control, 10 Education, and 12 Education+Feedback). Retention at 2-week follow-up was 52% (17/33; n=6 for Control, n=3 for Education, and n=8 for Education+Feedback). No study-related adverse events occurred. Collectively, patients responded to 106 out of 325 vibration prompts from the waist-worn inclinometer (32.62%). Within 5 min of the prompt, 41% of responses occurred, with patients standing for a mean 1.4 (SD 0.8) min and walking for 0.4 (SD 0.3) min (21, SD 11, steps). Interviews indicated that being unwell and overwhelmed after an exacerbation was the main reason for not engaging with the intervention. Health care staff considered reducing sedentary behavior potentially attractive for patients but suggested starting the intervention as an inpatient. CONCLUSIONS Although the data support that it was feasible to conduct the trial, modifications are needed to improve participant retention. The intervention was acceptable to most patients and health care professionals. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 13790881; http://www.isrctn.com/ISRCTN13790881 (Archived by WebCite at http://www.webcitation.org/6xmnRGjFf)


2020 ◽  
Vol 13 (4) ◽  
pp. 442-444
Author(s):  
Marek Postuła

Appropriate selection and correct use of inhalation devices is an integral component in the management of asthma and chronic obstructive pulmonary disease. It is well known that there are many challenges with the use of inhalers, and no one device suits all patients. Importantly, education and support is crucial, not only to enable patients to recognize the need for optimal disease management, but also to help them develop good inhaler technique. In addition, health care professionals should also aim to increase their knowledge of the devices they prescribe and develop systems to ensure that they offer comprehensive support to patients in clinical practice.


2015 ◽  
Vol 22 (3) ◽  
pp. 147-152 ◽  
Author(s):  
Pat G Camp ◽  
Paul Hernandez ◽  
Jean Bourbeau ◽  
Ashley Kirkham ◽  
Richard Debigare ◽  
...  

BACKGROUND: Pulmonary rehabilitation (PR) is a recommended intervention in the management of individuals with chronic lung disease. It is important to study the characteristics and capacity of programs in Canada to confirm best practices and identify future areas of program improvement and research.OBJECTIVE: To identify all Canadian PR programs, regardless of setting, and to comprehensively describe all aspects of PR program delivery. The present article reports the results of the survey related to type of program, capacity and program characteristics.METHODS: All hospitals in Canada were contacted to identify PR programs. A representative from each program completed a 175-item online survey encompassing 16 domains, 10 of which are reported in the present article.RESULTS: A total of 155 facilities in Canada offered PR, of which 129 returned surveys (83% response rate). PR programs were located in all provinces, but none in the three territories. Most (60%) programs were located in hospital settings, 24% were in public health units and 8% in recreation centres. The national capacity of programs was estimated to be 10,280 patients per year, resulting in 0.4% of all Canadians with chronic obstructive pulmonary disease (COPD) and 0.8% of Canadians with moderate to severe COPD having access to PR. COPD, interstitial lung disease, and asthma were the most common diagnoses of patients. The majority of programs had at least four health care professionals involved; 9% had only one health care professional involved.CONCLUSION: The present comprehensive survey of PR in Canada reports an increase in the number of programs and the total number of patients enrolled since the previous survey in 2005. However, PR capacity has not kept pace with demand, with only 0.4% of Canadians with COPD having access.


2017 ◽  
Author(s):  
Esther Metting ◽  
Aaltje Jantine Schrage ◽  
Janwillem WH Kocks ◽  
Robbert Sanderman ◽  
Thys van der Molen

BACKGROUND As accessibility to the internet has increased in society, many health care organizations have developed patient Web portals (PWPs), which can provide a range of self-management options to improve patient access. However, the available evidence suggests that they are used inefficiently and do not benefit patients with low health literacy. Asthma and chronic obstructive pulmonary disease (COPD) are common chronic diseases that require ongoing self-management. Moreover, patients with COPD are typically older and have lower health literacy. OBJECTIVE This study aimed to obtain and present an overview of patients’ perspectives of PWPs to facilitate the development of a portal that better meets the needs of patients with asthma and COPD. METHODS We performed a focus group study using semistructured interviews in 3 patient groups from the north of the Netherlands who were recruited through the Dutch Lung Foundation. Each group met 3 times for 2 hours each at a 1-week interval. Data were analyzed with coding software, and patient descriptors were analyzed with nonparametric tests. The consolidated criteria for reporting qualitative research were followed when conducting the study. RESULTS We included 29 patients (16/29, 55% male; mean age 65 [SD 10] years) with COPD (n=14), asthma-COPD overlap (n=4), asthma (n=10), or other respiratory disease (n=1). There was a large variation in the internet experience; some patients hardly used the internet (4/29, 14%), whereas others used internet >3 times a week (23/29, 79%). In general, patients were positive about having access to a PWP, considering access to personal medical records as the most important option, though only after discussion with their physician. A medication overview was considered a useful option. We found that communication between health care professionals could be improved if patients could use the PWP to share information with their health care professionals. However, as participants were worried about the language and usability of portals, it was recommended that language should be adapted to the patient level. Another concern was that disease monitoring through Web-based questionnaire use would only be useful if the results were discussed with health care professionals. CONCLUSIONS Participants were positive about PWPs and considered them a logical step. Today, most patients tend to be better educated and have internet access, while also being more assertive and better informed about their disease. A PWP could support these patients. Our participants also provided practical suggestions for implementation in current and future PWP developments. The next step will be to develop a portal based on these recommendations and assess whether it meets the needs of patients and health care providers.


2019 ◽  
Vol 33 (6) ◽  
pp. 663-675 ◽  
Author(s):  
A Carole Gardener ◽  
Gail Ewing ◽  
Morag Farquhar

Background: Patients with advanced chronic obstructive pulmonary disease have difficulty reporting their holistic support needs to health care professionals, undermining delivery of person-centred care. We lack tools that directly support patients with this. Aim: To develop an evidence-based, designed-for-purpose, tool to enable patients to directly identify and express support needs to health care professionals. Design: Two-stage qualitative study. Stage 1: domains of support need were identified through a systematic review, analysis of an established qualitative dataset and patient/carer focus groups. Stage 2: draft tool developed using the identified domains of need and then refined through feedback from patients, carers and health care professionals, ensuring acceptability and suitability. Setting/participants: Stage 1 patients/carers recruited via four primary care practices and two patient support groups (East of England). Stage 2 health care professionals recruited via the Clinical Research Network and local community trust and patients/carers through two further practices and two additional support groups (East of England). In total, 57 patients, carers and health care professionals participated. Results: A comprehensive set of evidence-based support domains (for example: overcoming boredom or loneliness, knowing what to expect in the future) was identified and formulated into questions. The resulting tool asks patients to consider whether they need more support in 15 broad areas. Patients, carers and clinical stakeholders broadly endorsed the tool’s content and wording. Conclusion: The Support Needs Approach for Patients (SNAP) tool is a concise evidence-based tool designed to help patients with advanced chronic obstructive pulmonary disease identify and express their support needs to enable delivery of person-centred care.


2009 ◽  
Vol 16 (3) ◽  
pp. 81-85 ◽  
Author(s):  
Dilshad Moosa ◽  
Maria Blouin ◽  
Kylie Hill ◽  
Roger Goldstein

BACKGROUND: The Canadian Thoracic Society (CTS) has developed a clinical practice guideline (CPG) regarding the management of patients with chronic obstructive pulmonary disease (COPD). Implementation of this CPG in the primary care setting requires an effective dissemination strategy.OBJECTIVES: To examine the change in knowledge, participant satisfaction and perceived changes in clinical practice among health care professionals working in the primary care setting following attendance at a workshop to disseminate the CTS CPG for COPD.METHODS: A 2.5 h workshop was conducted in three community health sites within Ontario. Each workshop comprised a didactic presentation and interactive case study discussions. Before, and one month following the workshop, a structured knowledge assessment questionnaire was administered. A structured satisfaction questionnaire and evaluative form that examined the impact of the workshop on the clinical management of COPD patients were administered immediately and three months following completion of the workshop, respectively.RESULTS: Sixty-nine participants attended the workshop. The mean score for the structured knowledge assessment questionnaire increased from 8.5±2.7 to 10.6±2.0 following the workshop (P=0.008). Eighty-nine per cent and 96% of participants indicated that they would recommend the workshop to a colleague and had greater confidence in their management of COPD patients, respectively. Following attendance of the workshop, 73%, 69% and 46% described increased patient education, patient monitoring and the use of objective testing in clinical practice, respectively.CONCLUSIONS: Workshop attendance was associated with high levels of satisfaction and important self-reported changes in clinical practice, which may reflect improved knowledge of the CTS CPG for COPD.


Sign in / Sign up

Export Citation Format

Share Document