Design, Development, and Evaluation of an mHealth App for Reporting of Side Effects During Cytostatic Treatment: Usability Test and Interview Study.

BACKGROUND: Using mobile health (mHealth) interventions such as smartphone apps to deliver health services is an opportunity to engage patients more actively in their own treatment. Usability tests allow for the evaluation of a service by testing it out on the relevant users before implementation in clinical practice. OBJECTIVE: The objective of this study was to design, develop, and evaluate the user interface of an app that would aid patients with cancer in reporting a more comprehensive summary of their side effects. METHODS: The usability test was conducted by exposing patients with cancer to a prototype of an mHealth app that allowed for reporting of side effects from a chemotherapy regimen. After solving a set of 13 tasks, the test participants completed a system usability scale questionnaire and were interviewed using a semistructured interview guide. The interviews were later transcribed and analyzed. RESULTS: The 10 test participants had a mean age of 56.5 (SD 7.11) years. The mean total task completion time for the task-solving session was 240.15 (SD 166.78) seconds. The calculated system usability scale score was 92.5. Most participants solved most of the tasks without any major issues. A minority reported having difficulties using apps on smartphones in general. One patient never achieved a meaningful interaction with our app prototype. Most of those who engaged with the app approved of features that calmed them down, made them more empowered, and put them in control. They preferred to report on side effects in a detailed and concise manner. App features that provided specific advice could provoke both fear and rational action. CONCLUSIONS: The user tests uncovered design flaws that allowed for subsequent refining of an app that has the potential to enhance the safety of patients undergoing home-based chemotherapy. However, a refined version of the app is unlikely to be of value to all patients. Some might not be able to use apps on smartphones in general, or their ability to use apps is impaired because of their disease. This finding should have implications for health care providers' overall design of their follow-up service as the service must allow for all the patients to receive safe treatment whether they can use an mHealth app or not.

Comparison of a Voluntary Safety Reporting System to a Global Trigger Tool for Identifying Adverse Events in an Oncology Population.

OBJECTIVE: There is a lack of research on adverse event (AE) detection in oncology patients, despite the propensity for iatrogenic harm. Two common methods include voluntary safety reporting (VSR) and chart review tools, such as the Institute for Healthcare Improvement's Global Trigger Tool (GTT). Our objective was to compare frequency and type of AEs detected by a modified GTT compared with VSR for identifying AEs in oncology patients in a larger clinical trial. METHODS: Patients across 6 oncology units (from July 1, 2013, through May 29, 2015) were randomly selected. Retrospective chart reviews were conducted by a team of nurses and physicians to identify AEs using the GTT. The VSR system was queried by the department of quality and safety of the hospital. Adverse event frequencies, type, and harm code for both methods were compared. RESULTS: The modified GTT detected 0.90 AEs per patient (79 AEs in 88 patients; 95% [0.71-1.12] AEs per patient) that were predominantly medication AEs (53/79); more than half of the AEs caused harm to the patients (41/79, 52%), but only one quarter were preventable (21/79; 27%). The VSR detected 0.24 AEs per patient (21 AEs in 88 patients; 95% [0.15-0.37] AEs per patient), a large plurality of which were medication/intravenous related (8/21); more than half did not cause harm (70%). Only 2% of the AEs (2/100) were detected by both methods. CONCLUSIONS: Neither the modified GTT nor the VSR system alone is sufficient for detecting AEs in oncology patient populations. Further studies exploring methods such as automated AE detection from electronic health records and leveraging patient-reported AEs are needed.

Cancer Patients' Perceived Value of a Smartphone App to Enhance the Safety of Home-Based Chemotherapy: Feasibility Study.

BACKGROUND: Oral anticancer therapies can be self-administered by patients outside the hospital setting, which poses challenges of adherence to a drug plan and monitoring of side effects. Modern information technology may be developed and implemented to address these pertinent issues. OBJECTIVE: The aim of this study was to explore how a smartphone app developed through a stepwise, iterative process can help patients using oral chemotherapy to take their drug, and to report adherence and side effects in a reliable and verifiable manner. METHODS: Fourteen patients starting capecitabine treatment were included in this study and used the smartphone app in addition to regular follow up of capecitabine treatment. Nine of these patients fulfilled the treatment plan and were interviewed based on a semistructured interview guide and the System Usability Scale (SUS). In addition, two focus groups were completed with 7 oncologists and 7 oncology nurses, respectively. Interview data were analyzed in accordance with the principles of systematic text condensation. Features of the app were also assessed. RESULTS: The smartphone app provided the patients with a feeling of reassurance regarding correct adherence of their oral chemotherapy treatment. They used the app as a memory tool about their treatment and possible serious side effects, as well as for treatment education. Patients expressed concerns about using the app to report side effects that were not considered to be obviously serious, fearing overreporting. The health personnel expressed an overall positive attitude to integrate this new tool in their everyday work. CONCLUSIONS: Patients on oral chemotherapy treatment at home felt safe and found the app to be helpful. The app promoted learning about their treatment and made the patients more independent of the cancer clinic, reducing the need for the clinic's limited resources for follow up of patients on oral anticancer medications.

The Impact of an eHealth Portal on Health Care Professionals' Interaction with Patients: Qualitative Study.

BACKGROUND: People who undergo weight loss surgery require a comprehensive treatment program to achieve successful outcomes. eHealth solutions, such as secure online portals, create new opportunities for improved health care delivery and care, but depend on the organizational delivery systems and on the health care professionals providing it. So far, these have received limited attention and the overall adoption of eHealth solutions remains low. In this study, a secure eHealth portal was implemented in a bariatric surgery clinic and offered to their patients. During the study period of 6 months, 60 patients and 5 health care professionals had access. The portal included patient information, self-management tools, and communication features for online dialog with peers and health care providers at the bariatric surgery clinic. OBJECTIVE: The aim of this study was to characterize and assess the impact of an eHealth portal on health care professionals' interaction with patients in bariatric surgery. METHODS: This qualitative case study involved a field study consisting of contextual interviews at the clinic involving observing and speaking with personnel in their actual work environment. Semi-structured in-depth interviews were conducted with health care professionals who interacted with patients through the portal. Analysis of the collected material was done inductively using thematic analysis. RESULTS: The analysis revealed two main dimensions of using an eHealth portal in bariatric surgery: the transparency it represents and the responsibility that follows by providing it. The professionals reported the eHealth portal as (1) a source of information, (2) a gateway to approach and facilitate the patients, (3) a medium for irrevocable postings, (4) a channel that exposes responsibility and competence, and (5) a tool in the clinic. CONCLUSIONS: By providing an eHealth portal to patients in a bariatric surgery program, health care professionals can observe patients' writings and revelations thereby capturing patient challenges and acting and implementing measures. Interacting with patients through the portal can prevent dropouts and deterioration of patients' health. However, professionals report on organizational challenges and personal constraints related to communicating with patients in writing online. Further development of guidelines and education of health care professionals about how to handle, prioritize, communicate, and facilitate patients online is required in addition to increased attention to the organizational infrastructures and incentives for enabling such solutions in health care.

What influences patient participation in an online forum for weight loss surgery? A qualitative case study.

BACKGROUND: Many patients who undergo weight loss (bariatric) surgery seek information and social support in online discussion forums, but the vast amount of available information raises concerns about the impact of such information. A secure online discussion forum was developed and offered to bariatric surgery patients. The forum was moderated and allowed contact with peers and health care professionals. OBJECTIVE: The purposes of this study were to explore how individuals undergoing bariatric surgery used the moderated discussion forum and to better understand what influenced their participation in the forum. METHODS: The study was designed as an explorative case study. We conducted participant observation of the discussion forum over a time period of approximately six months. For further insight, we carried out in-depth semistructured interviews with seven patients who had access to the forum. We analyzed the material inductively, using content and thematic analysis. RESULTS: The patients used the forum as an arena in which to interact with peers and providers, as well as to provide and achieve informational and social support. The analysis suggests that there are three major themes that influenced participation in the online discussion forum: (1) the participant's motivation to seek information, advice, and guidance, (2) the need for social support and networking among peers, and (3) concerns regarding self-disclosure. CONCLUSIONS: The findings of this study imply that a moderated discussion forum for bariatric surgery patients has potential for use in a therapeutic context. The discussion forum fulfilled the informational and support needs of the bariatric surgery patients and was particularly useful for those who excluded themselves from the traditional program and experienced barriers to expressing their own needs. Even though our findings imply that the patients benefitted from using the forum regardless of their active or passive participation, restraining factors, such as considerations regarding self-disclosure, must be further investigated to prevent certain users from being precluded from participation.

Process support for risk mitigation: a case study of variability and resilience in vascular surgery.

OBJECTIVE: To inform the design of IT support, the authors explored the characteristics and sources of process variability in a surgical care process that transcends multiple institutions and professional boundaries. SETTING: A case study of the care process in the Abdominal Aortic Aneurysm surveillance programme of three hospitals in Norway. DESIGN: Observational study of encounters between patients and surgeons accompanied by semistructured interviews of patients and key health personnel. RESULTS: Four process variety dimensions were identified. The captured process variations were further classified into intended and unintended variations according to the cause of the variations. Our main findings, however, suggest that the care process is best understood as systematised analysis and mitigation of risk. Even if major variations accommodated for the flexibility needed to achieve particular clinical aims and/or to satisfy patient preferences, other variations reflected healthcare actors' responses to risks arising from a lack of resilience in the existing system. On this basis, the authors outlined suggestions for a resilience-based approach by including awareness in workflow as well as feedback loops for adaptive learning. The authors suggest that IT process support should be designed to prevent process breakdowns with patient dropouts as well as to sustain risk-mitigating performance. CONCLUSION: Process variation was in part induced by systemised risk mitigation. IT-based process support for monitoring processes such as that studied here should aim to ensure resilience and further mitigate risk to enhance patient safety.

Getting the aorta pants in place: a 'community of guidance' in the evolving practice of vascular implant surgery.

The evolving nature of surgical treatments creates gaps between evidence-based guidelines and actual clinical practice.This article addresses the emerging clinical practice of the EndoVascular Aneurysm Repair (EVAR), a surgical treatment of patients with Abdominal Aortic Aneurysm (AAA). Drawing on a qualitative study across three hospitals, we identified three interplaying expertise traits: the collective, the interpersonal and the technical, each being present to promote surgical work. The evolvement of EVAR is contextualized within technical artefacts and patient characteristics, along with a joint decision approach. The intertwinement between various expertise traits and contextual factors forms a 'community of guidance', nourishing further EVAR innovation without formalized institutions, evidence, training or guidelines. However, the lack of a shared context limits the transfer of evolving knowledge across hospital boundaries.