Exploring barriers and facilitators to the implementation of pet robots for people with dementia in nursing homes: A qualitative research protocol

People living with dementia, especially those who live in nursing homes, are susceptible to social isolation and activity disengagement. Pet robots are technology-based substitutes to animal-assisted therapy that have demonstrated positive impacts on people with dementia in long term care settings, such as reducing agitation, improving mood and increasing social engagement. Nevertheless, knowledge about the issues influencing their implementation is lacking, as there is a scarcity of research that have explicitly investigated the barriers and facilitators influencing their implementation in real-world practice. The objective of this study is to understand the multi-level barriers and facilitators to the implementation of pet robots for people with living dementia in nursing homes, from the perspectives of key stakeholders. A qualitative study employing a descriptive qualitative approach will be used. The Consolidated Framework of Implementation Research (CFIR) will be used to guide the research process. Multi-level stakeholders, including people living with dementia, healthcare professionals and organisational decision makers in nursing homes, will be recruited for one-to-one interviews. Data will be analysed through framework analysis, using a combination of both deductive (based on the constructs and domains in the CFIR) and inductive approaches. To the best of our knowledge, this will be the first study to explore multi-level determinants to the implementation of pet robots in nursing homes for people living with dementia. Findings will be used to inform the identification of strategies that may be used to guide the implementation of pet robots for people living with dementia in nursing homes

A survey of knowledge, perceptions and use of core outcome sets among clinical trialists

Background: Core outcome sets (COS) are standardised sets of outcomes, which represent the minimum outcomes that should be measured and reported in clinical trials. COS can enhance comparability across health trials by reducing heterogeneity of outcome measurement and reporting and potentially minimising selective outcome reporting. Examining what researchers involved in trials know and think about COS is essential to increase awareness and promote COS uptake. The aim of this study is therefore to examine clinical trialists’ knowledge, perceptions and experiences of COS. Methods: An online survey design was used. Participants were clinical trialists, operationalised for the current study as researchers named as the contact person on a trial registered on the International Standard Randomised Controlled Trial Number (ISRCTN) Trial repository between 1 January 2019 and 21 July 2020. Survey items assessed clinical trialists’ familiarity with and understanding of COS, along with experiences of COS use and development. Results: Of 1913 clinical trialists contacted to participate, 62 (3%) completed the survey. Forty (65%) participants were familiar with COS and, of those familiar with COS, 21 (55%) had been involved in a trial that used a COS. Of clinical trialists who used COS in a trial(s), less than half (n = 9, 41%) reported that all COS outcomes were used. The main barriers to using COS are poor knowledge about COS (n = 43, 69%) and difficulties identifying relevant COS (n = 42, 68%). Clinical trialists also reported perceptions of COS as restrictive and often containing too many outcomes. The main enablers to using COS are clear understanding (n = 51, 82%) and perceived importance of COS (n = 44, 71%). Conclusions: Enhancing clinical trialists’ use of all COS outcomes is needed to reduce outcome heterogeneity and enhance comparability across trial findings. Enhancing awareness of COS importance among researchers and funders is needed to ensure that COS are developed and used by clinical trialists. Education and training may further promote awareness and understanding of COS

Epidemiology of undiagnosed depression in people with diabetes mellitus: a comparative analysis of Ireland, England and the USA

Objectives Improving detection of depression in people with diabetes is recommended. However, little is known about how different health systems compare in depression detection. We estimated and compared the (1) prevalence of depression detection in people with and without diabetes, and (2) association between diabetes and undiagnosed depression across three health systems. Design Cross-sectional analysis of three nationally representative studies: The Irish Longitudinal Study on Ageing, the English Longitudinal Study on Ageing and the Health and Retirement Study. Setting Community-dwelling adults in Ireland, England and the USA

Adapting health interventions for local fit when scaling-up: a realist review protocol.

Introduction Scaling-up is essential to ensure universal access of effective health interventions. Scaling-up is a complex process, which occurs across diverse systems and contexts with no one-size-fits-all approach. To date, little attention has been paid to the process of scaling-up in how to make adaptations for local fit. The aim of this research is to develop theory on what actions can be used to make adaptations to health interventions for local fit when scaling-up across diverse contexts that will have practical application for implementers involved in scalingup. Methods and analysis Given the complexity of this subject, a realist review methodology was selected. Specifically, realist review emphasises an iterative, non-linear process, whereby the review is refined as it progresses. The identification of how the context may activate mechanisms to achieve outcomes is used to generate theories on what works for whom in what circumstances. This protocol will describe the first completed stage of development of an initial programme theory framework, which identified potential actions, contexts, mechanisms and outcomes that could be used to make adaptations when scaling-up. It will then outline the methods for future stages of the review which will focus on identifying case examples of scale-up and adaptation in practice. This realist review consists of six stages: (i) clarifying scope and development of a theoretical framework, (ii) developing a search strategy, (iii) selection and appraisal, (iv) data extraction, (v) data synthesis and analysis and (vi) further theory refinement with stakeholders. Ethics and dissemination This review will develop theory on how adaptations can be made when scalingup. Findings will be disseminated in a peer-reviewed journal and through stakeholder engagement as part of the research process. Ethical approval has been received through Health Policy and Management/Centre for Global Health Research Ethics Committee of Trinity College Dublin

The usability and impact of a low-cost pet robot for older adults and people with dementia: qualitative content analysis of user experiences and perceptions on consumer websites

Background: Worldwide, populations are aging exponentially. Older adults and people with dementia are especially at risk of social isolation and loneliness. Social robots, including robotic pets, have had positive impacts on older adults and people with dementia by providing companionship, improving mood, reducing agitation, and facilitating social interaction. Nevertheless, the issue of affordability can hinder technology access. The Joy for All (JfA) robotic pets have showed promise as examples of low-cost alternatives. However, there has been no research that investigated the usability and impact of such low-cost robotic pets based on perceptions and experiences of its use with older adults and people with dementia. Objective: The aim of our study was to explore the usability and impact of the JfA robotic cat, as an example of a low-cost robot, based on perceptions and experiences of using the JfA cat for older adults and people with dementia. Methods: We used a novel methodology of analyzing a large volume of information that was uploaded by reviewers of the JfA cat onto online consumer review sites. Data were collected from 15 consumer websites. This provided a total of 2445 reviews. Next, all reviews were screened. A total of 1327 reviews that contained information about use of the JfA cat for older adults or people with dementia were included for analysis. These were reviews that contained terms relating to “older adults,” “dementia,” and “institutional care” and were published in the English language. Descriptive statistics was used to characterize available demographic information, and textual data were qualitatively analyzed using inductive content analysis. Results: Most reviews were derived from consumer sites in the United States, and most reviewers were family members of users (ie, older adults and people with dementia). Based on the qualitative content analysis, 5 key themes were generated: prior expectations, perceptions, meaningful activities, impacts, and practicalities. Reviewers had prior expectations of the JfA cat, which included circumstantial reasons that prompted them to purchase this technology. Their perceptions evolved after using the technology, where most reported positive perceptions about their appearance and interactivity. The use of the robot provided opportunities for users to care for it and incorporate it into their routine. Finally, reviewers also shared information about the impacts of device and practicalities related to its use. Conclusions: This study provides useful knowledge about the usability and impact of a low-cost pet robot, based on experiences and perceptions of its use. These findings can help researchers, robot developers, and clinicians understand the viability of using low-cost robotic pets to benefit older adults and people with dementia. Future research should consider evaluating design preferences for robotic pets, and compare the effects of low-cost robotic pets with other more technologically advanced robotic pets

Investigating group-based classes (‘weaning workshops’) to support complementary infant feeding in Irish primary care settings: a cross-sectional survey

Objective: This study aims to (1) investigate current practice regarding ‘weaning workshops’ to support complementary infant feeding delivered within Irish primary care, (2) explore the experiences and opinions of community dietitians regarding optimal content and modes of delivery of weaning workshops and (3) identify the key factors to be considered in the development and implementation of weaning workshops delivered within primary care. Design: Cross-sectional survey. Setting: Irish primary care. Participants: Forty-seven community-based dietitians. Results: Sixteen dietitians reported that workshops were run in their area with variable frequency, with ten reporting that workshops were never run in their area. Participants reported that mostly mothers of medium socio-economic status (SES) attended weaning workshops when infants were aged between 4 and 7 months, and that feedback from workshop attendees was predominantly positive. Dietitians identified that key factors to be considered in future development and delivery of weaning workshops are (1) workshop characteristics such as content, timing and venue, (2) organisational characteristics such as availability of resources and multidisciplinary involvement and (3) attendee characteristics such as SES. Conclusions: This study highlights substantial variability regarding provision of weaning workshops in Ireland, and a lack of standardisation regarding the provider, content and frequency of workshops where workshops are being delivered. The study also provides unique insights into the experiences and opinions of primary care community dietitians regarding the development and delivery of weaning workshops in terms of optimal content and delivery options. These perspectives will make a valuable contribution given the dearth of evidence in this area internationall

Influence of providing information to participants about development of trial outcomes on response rates and attitudes to questionnaire completion: Protocol for a study within a trial'

Background: Issues with questionnaire completion introduce bias and limit examinations in trials. Improving communication with participants about trial processes, such as outcome and questionnaire development, may improve questionnaire completion and response rates. Providing information about the involvement of stakeholders in the development of core outcome sets (COS) measured in trials may improve responding by tapping into subjective norms and behaviour change mechanisms. The aim of this Study Within a Trial (SWAT) is to examine if questionnaire response rates and participants’ attitudes towards questionnaire completion are impacted by providing information about COS use in a trial of a complex intervention. Methods: This is a randomised, single-blinded, parallel group intervention SWAT, embedded within a feasibility trial of an infant feeding intervention to prevent childhood obesity. The SWAT intervention consists of a brief written description and explanation about the development and use of a COS of infant feeding outcomes to prevent childhood obesity, used in the trial. Participants are parents or caregivers of infants aged two months at questionnaire completion. Participants will be randomly assigned to receive the SWAT intervention prior to questionnaire completion (SWAT Intervention), or not (SWAT Comparator). The primary outcome of interest is response rates, which will be measured as proportion of questionnaire completion and individual item response rates. Participants’ attitudes will also be assessed using closed-ended and an open-ended question to evaluate participants’ attitudes about questionnaire completion. Discussion: We hypothesise that providing information about development and use of a COS will increase questionnaire response rates and attitudes toward questionnaire completion relative to the control condition. Findings will indicate the potential usefulness of this strategy for improving participant attitudes and response rates in trials

Focusing on fidelity: narrative review and recommendations for improving intervention fidelity within trials of health behaviour change interventions

Background: Interventions to change behaviour have substantial potential to impact positively on individual and overall public health. Despite an increasing focus on health behaviour change intervention research, interventions do not always have the desired effect on outcomes, while others have diluted effects once implemented into real-life settings. There is little investment into understanding how or why such interventions work or do not work. Methodological inadequacies of trials of behavioural interventions have been previously suggested as a barrier to the quality and advancement of behavioural research, with intervention fidelity acknowledged as a key area for improvement. However, there is much ambiguity regarding the terminology and conceptualisation of intervention fidelity and a lack of practical guidance regarding how to address it sufficiently, particularly within trials of complex behavioural interventions. Objectives: This article outlines specific issues concerning intervention fidelity within trials of health behaviour change interventions and suggests practical considerations and specific recommendations for researchers, with examples from the literature presented. Conclusions: Recommendations pertain to (1) clarifying how fidelity is defined and conceptualised, (2) considering fidelity beyond intervention delivery, (3) considering strategies to both enhance and assess fidelity, (4) making use of existing frameworks and guidance, (5) considering the quality and comprehensiveness of fidelity assessment strategies, (6) considering the balance between fidelity and adaptation and (7) reporting the use of fidelity enhancement and assessment strategies and their results. Suggestions for future research to improve our understanding of, and ability to, address fidelity in behaviour change interventions are also provided

Health professional-delivered obesity prevention interventions during the first 1,000 days: a systematic review of external validity reporting.

Background: Childhood obesity prevention interventions delivered by health professionals during the first 1,000 days show some evidence of effectiveness, particularly in relation to behavioural outcomes. External validity refers to how generalisable interventions are to populations or settings beyond those in the original study. The degree to which external validity elements are reported in such studies is unclear however. This systematic review aimed to determine the extent to which childhood obesity interventions delivered by health professionals during the first 1,000 days report on elements that can be used to inform generalizability across settings and populations. Methods: Eligible studies meeting study inclusion and exclusion criteria were identified through a systematic review of 11 databases and three trial registers. An assessment tool based on the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework was used to assess the external validity of included studies. It comprised five dimensions: reach and representativeness of individuals, reach and representativeness of settings, implementation and adaptation, outcomes for decision making maintenance and/or institutionalisation. Two authors independently assessed the external validity of 20% of included studies; discrepancies were resolved, and then one author completed assessments of the remaining studies. Results: In total, 39 trials involving 46 interventions published between 1999 and 2019 were identified. The majority of studies were randomized controlled trials (n=24). Reporting varied within and between dimensions. External validity elements that were poorly described included: representativeness of individuals and settings, treatment receipt, intervention mechanisms and moderators, cost effectiveness, and intervention sustainability and acceptability. Conclusions: Our review suggests that more emphasis is needed on research designs that consider generalisability, and the reporting of external validity elements in early life childhood obesity prevention interventions. Important gaps in external validity reporting were identified that could facilitate decisions around the translation and scale-up of interventions from research to practice. Registration: PROSPERO CRD42016050793 03/11/16

Implementation of a calorie menu labeling policy in public hospitals: study protocol for a multiple case study

Background: Promotion of good nutrition is essential for reducing the risk of chronic disease and premature death. Evidence shows menu labeling interventions should be implemented in workplaces as part of a comprehensive approach to improve employees' dietary habits; however, implementation challenges have arisen. This article describes a protocol for a multiple case study to explore the factors that impact on implementation of a calorie menu labeling policy in Irish public hospitals. Methods: Using a multiple case study design, comprising four Irish acute public hospitals, this study will draw on multiple perspectives and sources of evidence (observations followed by interviews, focus groups, and documentary analysis) to allow for a comprehensive depth and breadth of inquiry. Data collection and analysis will be guided by the Consolidated Framework for Implementation Research, bringing together constructs from implementation theories to understand the complexity of implementing policies. Hospitals will be categorized into high and low implementers of the policy based on quantitative data obtained from structured observations. Using framework analysis, within- and cross-case analyses will be performed to identify factors influencing policy implementation and to identify distinguishing patterns across high and low implementers and across hospital direct and indirect stakeholders. Strategies will be employed to ensure rigorous case study research, for example, triangulation, audit trail, reflexivity, and thick descriptions. An integrated knowledge translation approach, where researchers work with stakeholders throughout the research process, will be adopted to facilitate the translation of research into policy and practice. Discussion: This protocol highlights methodological insights in utilizing case study research to gain a greater understanding of the menu labeling implementation process. Study findings will be relevant to policy makers and other stakeholders involved in the rollout of such interventions and will provide a foundation to select and tailor implementation strategies to assist with scale-up of calorie menu labeling across the health service