Broadening the Debate About Post-trial Access to Medical Interventions: A Qualitative Study of Participant Experiences at the End of a Trial Investigating a Medical Device to Support Type 1 Diabetes Self-Management

Lawton, Julia; Blackburn, Maxine; Rankin, David; Werner, Claudia D.; Farrington, Conor; Hovorka, Roman; Hallowell, Nina

doi:10.1080/23294515.2019.1592264

Cited by 21 publications

(39 citation statements)

References 34 publications

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“…These findings suggest that regular, ongoing reviews of individuals using closed‐loop systems will be essential, in line with recommendations for those using other diabetes technologies . Even if clear guidance is put in place for when to remove a closed‐loop system, this may still be a very challenging task , and effective team working may be vital .…”

Section: Discussionmentioning

confidence: 81%

Health professionals' views about who would benefit from using a closed‐loop system: a qualitative study

et al. 2020

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Aim To explore health professionals' views about who would benefit from using a closed-loop system and who should be prioritized for access to the technology in routine clinical care.Methods Health professionals (n = 22) delivering the Closed Loop from Onset in type 1 Diabetes (CLOuD) trial were interviewed after they had ≥ 6 months' experience supporting participants using a closed-loop system. Data were analysed thematically.Results Interviewees described holding strong assumptions about the types of people who would use the technology effectively prior to the trial. Interviewees described changing their views as a result of observing individuals engaging with the closed-loop system in ways they had not anticipated. This included educated, technologically competent individuals who over-interacted with the system in ways which could compromise glycaemic control. Other individuals, who health professionals assumed would struggle to understand and use the technology, were reported to have benefitted from it because they stood back and allowed the system to operate without interference. Interviewees concluded that individual, family and psychological attributes cannot be used as pre-selection criteria and, ideally, all individuals should be given the chance to try the technology. However, it was recognized that clinical guidelines will be needed to inform difficult decisions about treatment allocation (and withdrawal), with young children and infants being considered priority groups.Conclusions To ensure fair and equitable access to closed-loop systems, prejudicial assumptions held by health professionals may need to be addressed. To support their decision-making, clinical guidelines need to be made available in a timely manner.

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Section: Discussionmentioning

confidence: 81%

Health professionals' views about who would benefit from using a closed‐loop system: a qualitative study

et al. 2020

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“…Many cited a need for on-going monitoring of trial participants for some time following trial exit. The same concern has been expressed by several other authors (Lawton et al (2019), and Bukenya, Seeley, Tumwekwase, Kabunga, and Ruzagira (2020)) who demonstrate that additional follow up and support of HIV positive clients following linkage to care significantly improved their general outcomes. The need to compensate trial participants for their engagement in research was another issue raised in the current study, .…”

Section: Discussionmentioning

confidence: 59%

“…The copyright holder for this this version posted November 16, 2020. ; https://doi.org/10.1101/2020.11.14.20231720 doi: medRxiv preprint 1 1 important to reduce negative emotional effects associated with trial closure (Lawton et al, 2019), and to offer guidance to participants on the next steps in accessing HIV care.…”

Section: Discussionmentioning

confidence: 99%

“…The copyright holder for this this version posted November 16, 2020. ; https://doi.org/10.1101/2020.11.14.20231720 doi: medRxiv preprint 3 trial closure (Cho et al, 2018). Additionally, the need for monitoring and compensation for potential adverse effects from trial interventions (Lawton et al, 2019), and provision of trial feedback (Chen et al, 2016;Schroter, Price, Malički, Richards, & Clarke, 2019), have been key concerns in post-trial (research) ethics.…”

Section: Introductionmentioning

confidence: 99%

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Ethical and practical considerations in HIV drug trial closure: perspectives of research staff in Uganda

Nalubega

Cox

Mugerwa

et al. 2020

Preprint

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There is a gap in evidence regarding how research trial closure processes are managed to ensure continuity of HIV care for HIV positive participants following trial closure within low income settings. This research aimed to establish how research staff in Uganda understood and practised post-trial care for HIV positive trial participants. A grounded theory study was conducted using in-depth individual interviews and focus group discussions with 22 research staff from 3 different trials in Uganda, in 2014-2015. The results indicated that researchers engaged in three main activities to support trial participants, including; (i) preparing for post-trial care, which included instituting trial closure guidelines, planning necessary resources, and informing trial participants about post-trial care; (ii) facilitating participants during trial exit by engaging in psychological and practical support activities, and (iii) providing follow up care and support for participants after trial exit, to respond to the needs of trial participants which often arose after trial exit. This study established a need for a holistic approach to post-trial-care of HIV positive trial participants in Uganda, and the need to engage multiple stakeholders including ethics authorities.

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“…Participants eagerly awaited their appointments with the dietitian, and the cessation of the intervention at 18 weeks shocked and saddened them, as they felt a keen sense of loss. These psychological and emotional effects on participants at the conclusion of trials have been reported in a number of other qualitative articles examining postintervention transition to usual care, with participants reporting a sense of loss, disappointment, anxiety, and isolation [32,33]. This highlights the need to incorporate how to manage the psychological impacts of abrupt cessation of intensive interventions on trial participants in the future [33].…”

Section: A Sense Of Support and Security Through Relationship Buildinmentioning

confidence: 76%

Attitudes of Australian Patients Undergoing Treatment for Upper Gastrointestinal Cancers to Different Models of Nutrition Care Delivery: Qualitative Investigation

Furness¹,

Huggins²,

Truby³

et al. 2021

JMIR Form Res

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Background Adults diagnosed with cancers of the stomach, esophagus, and pancreas are at high risk of malnutrition. In many hospital-based health care settings, there is a lack of systems in place to provide the early and intensive nutritional support that is required by these high-risk cancer patients. Our research team conducted a 3-arm parallel randomized controlled trial to test the provision of an early and intensive nutrition intervention to patients with upper gastrointestinal cancers using a synchronous telephone-based delivery approach versus an asynchronous mobile app–based approach delivered using an iPad compared with a control group to address this issue. Objective This study aims to explore the overall acceptability of an early and intensive eHealth nutrition intervention delivered either via a synchronous telephone-based approach or an asynchronous mobile app–based approach. Methods Patients who were newly diagnosed with upper gastrointestinal cancer and who consented to participate in a nutrition intervention were recruited. In-depth, semistructured qualitative interviews were conducted by telephone and transcribed verbatim. Data were analyzed using deductive thematic analysis using the Theoretical Framework of Acceptability in NVivo Pro 12 Plus. Results A total of 20 participants were interviewed, 10 from each intervention group (synchronous or asynchronous delivery). Four major themes emerged from the qualitative synthesis: participants’ self-efficacy, low levels of burden, and intervention comprehension were required for intervention effectiveness and positive affect; participants sought a sense of support and security through relationship building and rapport with their dietitian; knowledge acquisition and learning-enabled empowerment through self-management; and convenience, flexibility, and bridging the gap to hard-to-reach individuals. Conclusions Features of eHealth models of nutrition care delivered via telephone and mobile app can be acceptable to those undergoing treatment for upper gastrointestinal cancer. Convenience, knowledge acquisition, improved self-management, and support were key benefits for the participants. Future interventions should focus on home-based interventions delivered with simple, easy-to-use technology. Providing participants with a choice of intervention delivery mode (synchronous or asynchronous) and allowing them to make individual choices that align to their individual values and capabilities may support improved outcomes. Trial Registration Australian and New Zealand Clinical Trial Registry (ACTRN) 12617000152325; https://tinyurl.com/p3kxd37b.

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Broadening the Debate About Post-trial Access to Medical Interventions: A Qualitative Study of Participant Experiences at the End of a Trial Investigating a Medical Device to Support Type 1 Diabetes Self-Management

Cited by 21 publications

References 34 publications

Health professionals' views about who would benefit from using a closed‐loop system: a qualitative study

Health professionals' views about who would benefit from using a closed‐loop system: a qualitative study

Ethical and practical considerations in HIV drug trial closure: perspectives of research staff in Uganda

Attitudes of Australian Patients Undergoing Treatment for Upper Gastrointestinal Cancers to Different Models of Nutrition Care Delivery: Qualitative Investigation

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