Selecting Outcomes to Ensure Pragmatic Trials Are Relevant to People Living with Dementia

Hanson, Laura C.; Bennett, Antonia V.; Jonsson, Martin; Kelley, Amy S.; Ritchie, Christine S.; Saliba, Debra; Teno, Joan M.; Zimmerman, Sheryl

doi:10.1111/jgs.16619

Cited by 18 publications

(55 citation statements)

References 55 publications

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“…Importantly, in these situations self-report is preferred where possible and should not be discounted. The challenge of shifting to proxy report where and if needed is a prominent one in dementia research [8].…”

Section: Introductionmentioning

confidence: 99%

The use of proxies and proxy-reported measures: a report of the international society for quality of life research (ISOQOL) proxy task force

et al. 2021

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Aims Proxy reports are often used when patients are unable to self-report. It is unclear how proxy measures are currently in use in adult health care and research settings. We aimed to describe how proxy reports are used in these settings, including the use of measures developed specifically for proxy reporting in adult health populations. Methods We systematically searched Medline, PsycINFO, PsycTESTS, CINAHL and EMBASE from database inception to February 2018. Search terms included a combination of terms for quality of life and health outcomes, proxy-reporters, and health condition terms. The data extracted included clinical context, the name of the proxy measure(s) used and other descriptive data. We determined whether the measures were developed specifically for proxy use or were existing measures adapted for proxy use. ResultsThe database search identified 17,677 possible articles, from which 14,098 abstracts were reviewed. Of these, 11,763 were excluded and 2335 articles were reviewed in full, with 880 included for data extraction. The most common clinical settings were dementia (30%), geriatrics (15%) and cancer (13%). A majority of articles (51%) were paired studies with proxy and patient responses for the same person on the same measure. Most paired studies (77%) were concordance studies comparing patient and proxy responses on these measures. Discussion Most published research using proxies has focused on proxy-patient concordance. Relatively few measures used in research with proxies were specifically developed for proxy use. Future work is needed to examine the performance of measures specifically developed for proxies. Systematic review registration PROSPERO No. CRD42018103179 Keywords Proxy measures • Proxy-reported outcomes • Outcome measures • Quality of life • Systematic review * Jessica K. Roydhouse

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Section: Introductionmentioning

confidence: 99%

The use of proxies and proxy-reported measures: a report of the international society for quality of life research (ISOQOL) proxy task force

et al. 2021

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“…The summary characteristics of all seven publications are presented in Table 1 . Four were published in peer-reviewed journals [ 6 , 34 – 36 ], two were conference posters [ 37 , 38 ] and one was an online published report [ 39 ]. Four of the publications [ 6 , 36 , 37 , 39 ] did not focus on a specific patient population or clinical area and provided recommendations applicable to the general patient cohorts.…”

Section: Resultsmentioning

confidence: 99%

Systematic review of guidance for the collection and use of patient-reported outcomes in real-world evidence generation to support regulation, reimbursement and health policy

Maruszczyk

Aiyegbusi

Torlińska

et al. 2022

J Patient Rep Outcomes

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Background Real-world evidence (RWE) plays an increasingly important role within global regulatory and reimbursement processes. RWE generation can be enhanced by the collection and use of patient-reported outcomes (PROs), which can provide valuable information on the effectiveness, safety, and tolerability of health interventions from the patient perspective. This systematic review aims to examine and summarise the available PRO-specific recommendations and guidance for RWE generation. Methods and findings Medical Literature Analysis and Retrieval System Online, Excerpta Medica Database, and websites of selected organisations were systematically searched to identify relevant publications. 1,249 articles were screened of which 7 papers met the eligibility criteria and were included in the review. The included publications provided PRO-specific recommendations to facilitate the use of PROs for RWE generation and these were extracted and grouped into eight major categories. These included: (1) instrument selection, (2) participation and engagement, (3) burden to health care professionals and patients, (4) stakeholder collaboration, (5) education and training, (6) PRO implementation process, (7) data collection and management, and (8) data analysis and presentation of results. The main limitation of the study was the potential exclusion of relevant publications, due to poor indexing of the databases and websites searched. Conclusions PROs may provide valuable and crucial patient input in RWE generation. Whilst valuable insights can be gained from guidance for use of PROs in clinical care, there is a lack of international guidance specific to RWE generation in the context of use for regulatory decision-making, reimbursement, and health policy. Clear and appropriate evidence-based guidance is required to maximise the potential benefits of implementing PROs for RWE generation. Unique aspects between PRO guidance for clinical care and other purposes should be differentiated. The needs of various stakeholder groups (including patients, health care professionals, regulators, payers, and industry) should be considered when developing future guidelines.

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“…Finally, there is a need to expand our focus to a broader range of outcomes that matter to people living with dementia and their care partners. 14 Evidence-based care approaches have focused on outcomes identified by researchers, which are frailty- and deficit-focused, 4 rather than on how to best optimize the experience of living with dementia, considering what most people want as their goal in life, which is to flourish. Given the enormous amount of work that creates a clearer picture of optimal dementia care, we are now at an ideal point to consider more carefully what outcomes we should be seeking to affect.…”

Section: Assessing the Delivery Of Person-centered Carementioning

confidence: 99%

Recommendations to Deliver Person-Centered Long-Term Care for Persons Living With Dementia

Wagner

Haitsma

Kolanowski

et al. 2021

Journal of the American Medical Directors Association

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Person-centered care (PCC) is the standard for the delivery of long-term services and supports (LTSS). In this article, we summarize the state of the science on meaningful outcomes and workforce development and discuss what is needed to ensure that person-centered LTSS becomes a universal reality. These 2 themes are intimately related: the dementia care workforce's capacity cannot be improved until care processes and outcomes that are significant to PCC are explicated. The LTSS workforce needs training in PCC as well as pragmatic measures to assess the quality of the care they provide. We conclude with several recommendations for future policy and practice-oriented workforce research.

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Selecting Outcomes to Ensure Pragmatic Trials Are Relevant to People Living with Dementia

Abstract: Outcome measures for embedded pragmatic clinical trials (ePCTs) should reflect the lived experience of people living with dementia (PLWD) and their caregivers, yet patient-and caregiverreported outcomes (PCROs) are rarely available in large clinical and administrative data sources.

Cited by 18 publications

References 55 publications

The use of proxies and proxy-reported measures: a report of the international society for quality of life research (ISOQOL) proxy task force

The use of proxies and proxy-reported measures: a report of the international society for quality of life research (ISOQOL) proxy task force

Systematic review of guidance for the collection and use of patient-reported outcomes in real-world evidence generation to support regulation, reimbursement and health policy

Recommendations to Deliver Person-Centered Long-Term Care for Persons Living With Dementia

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