Multidisciplinary Software Design for the Routine Monitoring and Assessment of Pain in Palliative Care Services: The Development of PainCheck

Allsop, Matthew J; Johnson, Owen; Taylor, Sally; Hackett, Julia; Allen, Peter M.; Bennett, Mike; Bewick, Bridgette M.

doi:10.1200/cci.18.00120

Cited by 9 publications

(6 citation statements)

References 47 publications

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“…13 In a previous paper in this journal, we described the development of a clinical decision-support tool with a focus on usability and clinical utility. 30 In this paper, we take a patient safety perspective to describe a case study of the development of a computerized, clinical decision-support system for cancer risk assessment embedded within an electronic health record system. As a class I medical device, the tool requires minimal consideration for patient safety despite influencing clinical decisions that, while not therapeutic nor diagnostic, nevertheless affect patient care and their journey through the health system.…”

Section: Context Key Objectivementioning

confidence: 99%

“…27 An introductory guide can be found in Medicines and Healthcare products Regulatory Agency: An Introductory Guide to the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR). 28 Although progress has been made in the creation of methods for software development, like Discipline Agile Delivery, 29,30 the focus has been on the technical performance given initial requirement specifications that do not always include safety. This is despite calls from as far back in the 1980s for an acceptable safety level to be designed into software systems before actual production or operation.…”

Section: Introductionmentioning

confidence: 99%

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Are Regulations Safe? Reflections From Developing a Digital Cancer Decision-Support Tool

McInerney

Scott²,

Johnson

2021

JCO Clinical Cancer Informatics

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PURPOSE Informatics solutions to early diagnosis of cancer in primary care are increasingly prevalent, but it is not clear whether existing and planned standards and regulations sufficiently address patients' safety nor whether these standards are fit for purpose. We use a patient safety perspective to reflect on the development of a computerized cancer risk assessment tool embedded within a UK primary care electronic health record system. METHODS We developed a computerized version of the CAncer Prevention in ExetER studies risk assessment tool, in compliance with the European Union's Medical Device Regulations. The process of building this tool afforded an opportunity to reflect on clinical concerns and whether current regulations for medical devices are fit for purpose. We identified concerns for patient safety and developed nine practical recommendations to mitigate these concerns. RESULTS We noted that medical device regulations (1) were initially created for hardware devices rather than software, (2) offer one-shot approval rather than supporting iterative innovation and learning, (3) are biased toward loss-transfer approaches that attempt to manage the fallout of harm instead of mitigating hazards becoming harmful, and (4) are biased toward known hazards, despite unknown hazards being an expected consequence of health care as a complex adaptive system. Our nine recommendations focus on embedding less-reductionist and stronger system perspectives into regulations and standards. CONCLUSION Our intention is to share our experience to support research-led collaborative development of health informatics solutions in cancer. We argue that regulations in the European Union do not sufficiently address the complexity of healthcare information systems with consequences for patient safety. Future standards and regulations should continue to follow a system-based approach to risk, safety, and accident avoidance.

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Section: Context Key Objectivementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Are Regulations Safe? Reflections From Developing a Digital Cancer Decision-Support Tool

McInerney

Scott²,

Johnson

2021

JCO Clinical Cancer Informatics

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“…This research has been published. 56 An eHealth intervention for routine assessment of pain: PainCheck Allsop et al 57 We adopted a research-led development process that sought to develop an ICT system that met the needs of patients and health professionals in real clinical settings and that was fit for clinical trial. Agile software development methods were combined with health science research methods and 'participatory design, ' including diary studies, face-to-face interviews, questionnaires, observations of clinical settings, prototyping, think-aloud, agile sprints, process reviews, requirements clustering and pilots.…”

Section: Work Package 22: Ensuring Engagement Of Patients and Health Professionalsmentioning

confidence: 99%

“…This research has been published. 57 PainCheck was accessed by patients and health professionals through a website hosted by the University of Leeds. PainCheck allows patients to record their pain and gives them access to personalised pain management advice.…”

Section: Work Package 22: Ensuring Engagement Of Patients and Health Professionalsmentioning

confidence: 99%

Pain self-management interventions for community-based patients with advanced cancer: a research programme including the IMPACCT RCT

Bennett

Allsop

Allen³

et al. 2021

Programme Grants Appl Res

Self Cite

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Background Each year in England and Wales, 150,000 people die from cancer, of whom 110,000 will suffer from cancer pain. Research highlights that cancer pain remains common, severe and undertreated, and may lead to hospital admissions. Objective To develop and evaluate pain self-management interventions for community-based patients with advanced cancer. Design A programme of mixed-methods intervention development work leading to a pragmatic multicentre randomised controlled trial of a multicomponent intervention for pain management compared with usual care, including an assessment of cost-effectiveness. Participants Patients, including those with metastatic solid cancer (histological, cytological or radiological evidence) and/or those receiving anti-cancer therapy with palliative intent, and health professionals involved in the delivery of community-based palliative care. Setting For the randomised controlled trial, patients were recruited from oncology outpatient clinics and were randomly allocated to intervention or control and followed up at home. Interventions The Supported Self-Management intervention comprised an educational component called Tackling Cancer Pain, and an eHealth component for routine pain assessment and monitoring called PainCheck. Main outcome measures The primary outcome was pain severity (measured using the Brief Pain Inventory). The secondary outcomes included pain interference (measured using the Brief Pain Inventory), participants’ pain knowledge and experience, and cost-effectiveness. We estimated costs and health-related quality-of-life outcomes using decision modelling and a separate within-trial economic analysis. We calculated incremental cost-effectiveness ratios per quality-adjusted life-year for the trial period. Results Work package 1 – We found barriers to and variation in the co-ordination of advanced cancer care by oncology and primary care professionals. We identified that the median time between referral to palliative care services and death for 42,758 patients in the UK was 48 days. We identified key components for self-management and developed and tested our Tackling Cancer Pain resource for acceptability. Work package 2 – Patients with advanced cancer and their health professionals recognised the benefits of an electronic system to monitor pain, but had reservations about how such a system might work in practice. We developed and tested a prototype PainCheck system. Work package 3 – We found that strong opioids were prescribed for 48% of patients in the last year of life at a median of 9 weeks before death. We delivered Medicines Use Reviews to patients, in which many medicines-related problems were identified. Work package 4 – A total of 161 oncology outpatients were randomised in our clinical trial, receiving either supported self-management (n = 80) or usual care (n = 81); their median survival from randomisation was 53 weeks. Primary and sensitivity analyses found no significant treatment differences for the primary outcome or for other secondary outcomes of pain severity or health-related quality of life. The literature-based decision modelling indicated that information and feedback interventions similar to the supported self-management intervention could be cost-effective. This model was not used to extrapolate the outcomes of the trial over a longer time horizon because the statistical analysis of the trial data found no difference between the trial arms in terms of the primary outcome measure (pain severity). The within-trial economic evaluation base-case analysis found that supported self-management reduced costs by £587 and yielded marginally higher quality-adjusted life-years (0.0018) than usual care. However, the difference in quality-adjusted life-years between the two trial arms was negligible and this was not in line with the decision model that had been developed. Our process evaluation found low fidelity of the interventions delivered by clinical professionals. Limitations In the randomised controlled trial, the low fidelity of the interventions and the challenge of the study design, which forced the usual-care arm to have earlier access to palliative care services, might explain the lack of observed benefit. Overall, 71% of participants returned outcome data at 6 or 12 weeks and so we used administrative data to estimate costs. Our decision model did not include the negative trial results from our randomised controlled trial and, therefore, may overestimate the likelihood of cost-effectiveness. Conclusions Our programme of research has revealed new insights into how patients with advanced cancer manage their pain and the challenges faced by health professionals in identifying those who need more help. Our clinical trial failed to show an added benefit of our interventions to enhance existing community palliative care support, although both the decision model and the economic evaluation of the trial indicated that supported self-management could result in lower health-care costs. Future work There is a need for further research to (1) understand and facilitate triggers that prompt earlier integration of palliative care and pain management within oncology services; (2) determine the optimal timing of technologies for self-management; and (3) examine prescriber and patient behaviour to achieve the earlier initiation and use of strong opioid treatment. Trial registration Current Controlled Trials ISRCTN18281271. Funding This project was funded by the National Institute for Health Research Programme Grants for Applied Research programme and will be published in full in Programme Grants for Applied Research; Vol. 9, No. 15. See the NIHR Journals Library website for further project information.

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“…Most mHealth apps developed for cancer pain facilitate pain reporting without tailored psychoeducation. [13,16,17] Others have taught behavioral pain management strategies via pre-recorded lessons or video chat with a therapist, but have had limited support for the medical aspects of self-management. [12,18,19] Existing mHealth symptom support interventions have not fully capitalized upon the technology to personalize symptom education and support (i.e.…”

Section: Introductionmentioning

confidence: 99%

Leveraging mobile health technology and research methodology to optimize patient education and self-management support for advanced cancer pain

Azizoddin

Adam

Kessler

et al. 2021

Support Care Cancer

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Purpose: Patient education is critical for management of advanced cancer pain, yet the benefits of psychoeducational interventions have been modest. We used mobile health (mHealth) technology to better meet patients' needs.Methods: Using the Agile and mHealth Development and Evaluation Frameworks, a multidisciplinary team of clinicians, researchers, patients, and design specialists followed a four-phase iterative process to develop comprehensive, tailored, multimedia cancer pain education for a patient-facing smartphone application. The target population reviewed the content and provided feedback. Results:The resulting application provides comprehensive cancer pain education spanning pharmacologic and behavioral aspects of self-management. Custom graphics, animated videos, quizzes, and audio-recorded meditations complemented written content. Computable algorithms based upon daily symptom surveys were used to deliver brief, tailored motivational messages that linked to more comprehensive teaching. Patients found the combination of pharmacologic and behavioral support to be engaging and helpful. Conclusion:Digital technology can be used to provide cancer pain education that is engaging, and tailored to individual needs. A replicable interdisciplinary and patient-centered approach to intervention development was advantageous. MHealth interventions may be a scalable approach to improve cancer pain. Frameworks that merge software and research methodology can be useful in developing interventions.

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Multidisciplinary Software Design for the Routine Monitoring and Assessment of Pain in Palliative Care Services: The Development of PainCheck

Cited by 9 publications

References 47 publications

Are Regulations Safe? Reflections From Developing a Digital Cancer Decision-Support Tool

Are Regulations Safe? Reflections From Developing a Digital Cancer Decision-Support Tool

Pain self-management interventions for community-based patients with advanced cancer: a research programme including the IMPACCT RCT

Leveraging mobile health technology and research methodology to optimize patient education and self-management support for advanced cancer pain

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