Selective outcome reporting in trials of behavioural health interventions in health psychology and behavioural medicine journals: a review.

Selective outcome reporting can result in overestimation of treatment effects, research waste, and reduced openness and transparency. This review aimed to examine selective outcome reporting in trials of behavioural health interventions and determine potential outcome reporting bias. A review of nine health psychology and behavioural medicine journals was conducted to identify randomised controlled trials of behavioural health interventions published since 2019. Discrepancies in outcome reporting were observed in 90% of the 29 trials with corresponding registrations/protocols. Discrepancies included 72% of trials omitting prespecified outcomes; 55% of trials introduced new outcomes. Thirty-eight percent of trials omitted prespecified and introduced new outcomes. Three trials (10%) downgraded primary outcomes in registrations/protocols to secondary outcomes in final reports; downgraded outcomes were not statistically significant in two trials. Five trials (17%) upgraded secondary outcomes to primary outcomes; upgraded outcomes were statistically significant in all trials. In final reports, three trials (7%) omitted outcomes from the methods section; three trials (7%) introduced new outcomes in results that were not in the methods. These findings indicate that selective outcome reporting is a problem in behavioural health intervention trials. Journal- and trialist-level approaches are needed to minimise selective outcome reporting in health psychology and behavioural medicine.

Demystifying Open Science in health psychology and behavioral medicine: a practical guide to Registered Reports and Data Notes.

Open Science practices are integral to increasing transparency, reproducibility, and accessibility of research in health psychology and behavioral medicine. Drives to facilitate Open Science practices are becoming increasingly evident in journal editorial policies, including the establishment of new paper formats such as Registered Reports and Data Notes. This paper provides: (i) an overview of the current state of Open Science policies within health psychology and behavioral medicine, (ii) a call for submissions to an Article Collection of Registered Reports and Data Notes as new paper formats within the journal of Health Psychology & Behavioral Medicine, (iii) an overview of Registered Reports and Data Notes, and (iv) practical considerations for authors and reviewers of Registered Reports and Data Notes.

Using behavioral science to increase core outcome set use in trials.

OBJECTIVES: Core outcome sets (COS) are agreed sets of outcomes for use in clinical trials, which can increase standardization and reduce heterogeneity of outcomes in research. Using a COS, or not, is a behavior that can potentially be increased using behavioral strategies. The aim of this study was to identify behavioral intervention components to potentially increase use of COS in trials. METHODS: This project was informed by the Behavior Change Wheel framework. Two reviewers extracted barriers and facilitators to COS use from four recently published studies examining COS use in trials. Barriers and facilitators were coded to the Capability, Opportunity, Motivation-Behavior (COM-B) model, which forms part of the Behavior Change Wheel. COM-B findings were mapped to intervention functions by two reviewers, and then mapped to behavior change techniques (BCTs). Full-team Affordability, Practicability, Effectiveness/Cost-effectiveness, Acceptability, Side effects/Safety, Equity ratings were used to reach consensus on intervention functions and BCTs. BCTs were operationalized using examples of tangible potential applications and were categorized based on similarity. RESULTS: Barriers and facilitators were identified for all capability, opportunity and motivation aspects of the COM-B model. Five intervention functions (education, training, enablement, persuasion, and modeling) and 15 BCTs were identified. Thirty-six BCT examples were developed, including providing information on benefits of COS for health research, and information choosing COS. BCT examples are categorized by approaches related to "workshops," "guidance," "audio/visual resources," and "other resources." CONCLUSION: Study findings represent diverse ways to potentially increase COS use in trials. Future work is needed to examine effects of these behavioral intervention components on COS use. If effective, increased use of COS can improve outcome reporting and minimize outcome heterogeneity and research waste.

Qualitative data sharing practices in clinical trials in the UK and Ireland: towards the production of good practice guidance.

Background: Data sharing enables researchers to conduct novel research with previously collected datasets, thus maximising scientific findings and cost effectiveness, and reducing research waste. The value of sharing, even de-identified, quantitative data from clinical trials is well recognised with a moderated access approach recommended. While substantial challenges to sharing quantitative data remain, there are additional challenges for sharing qualitative data in trials. Incorporating the necessary information about how qualitative data will be shared into already complex trial recruitment and consent processes proves challenging. The aim of this study was to explore whether and how trial teams share qualitative data collected as part of the design, conduct, analysis, or delivery of clinical trials. Methods: Phase 1 involved semi-structured, in-depth qualitative interviews and focus groups with key trial stakeholder groups including trial managers and clinical trialists (n=3), qualitative researchers in trials (n=9), members of research funding bodies (n=2) and trial participants (n=1). Data were analysed using thematic analysis. In Phase 2, we conducted a content analysis of 16 participant information leaflets (PIL) and consent forms (CF) for trials that collected qualitative data. Results: Three key themes were identified from our Phase 1 findings: ' Understanding and experiences of the potential benefits of sharing qualitative data from trials', 'Concerns about qualitative data sharing', and ' Future guidance and funding'. In phase 2, the PILs and CFs received revealed that the benefits of data sharing for participants were only explained in two of the study documents. Conclusions: The value of sharing qualitative data was acknowledged, but there are many uncertainties as to how, when, and where to share this data. In addition, there were ethical concerns in relation to the consent process required for qualitative data sharing in trials. This study provides insight into the existing practice of qualitative data sharing in trials.

Development of a video-based evidence synthesis knowledge translation resource: Drawing on a user-centred design approach.

Objectives: We aimed to develop a video animation knowledge translation (KT) resource to explain the purpose, use and importance of evidence synthesis to the public regarding healthcare decision-making. Methods: We drew on a user-centred design approach to develop a spoken animated video (SAV) by conducting two cycles of idea generation, prototyping, user testing, analysis, and refinement. Six researchers identified the initial key messages of the SAV and informed the first draft of the storyboard and script. Seven members of the public provided input on this draft and the key messages through think-aloud interviews, which we used to develop an SAV prototype. Seven additional members of the public participated in think-aloud interviews while watching the video prototype. All members of the public also completed a questionnaire on perceived usefulness, desirability, clarity and credibility. We subsequently synthesised all data to develop the final SAV. Results: Researchers identified the initial key messages as 1) the importance of evidence synthesis, 2) what an evidence synthesis is and 3) how evidence synthesis can impact healthcare decision-making. Members of the public rated the initial video prototype as 9/10 for usefulness, 8/10 for desirability, 8/10 for clarity and 9/10 for credibility. Using their guidance and feedback, we produced a three-and-a-half-minute video animation. The video was uploaded on YouTube, has since been translated into two languages, and viewed over 12,000 times to date. Conclusions: Drawing on user-centred design methods provided a structured and transparent approach to the development of our SAV. Involving members of the public enhanced the credibility and usefulness of the resource. Future work could explore involving the public from the outset to identify key messages in developing KT resources explaining methodological topics. This study describes the systematic development of a KT resource with limited resources and provides transferrable learnings for others wishing to do similar.

A qualitative study exploring perceived barriers and enablers to fidelity of training and delivery for an intervention to reduce non-indicated imaging for low back pain.

BACKGROUND: Non-specific low back pain (LBP) commonly presents to primary care, where inappropriate use of imaging remains common despite guideline recommendations against its routine use. Little is known about strategies to enhance intervention fidelity (i.e., whether interventions were implemented as intended) for interventions developed to reduce non-indicated imaging for LBP. OBJECTIVES: We aim to inform the development of an intervention to reduce non-indicated imaging among general practitioners (GPs) and chiropractors in Newfoundland and Labrador (NL), Canada. The study objectives are: [1] To explore perceived barriers and enablers to enhancing fidelity of training of GPs and chiropractors to deliver a proposed intervention to reduce non-indicated imaging for LBP and [2] To explore perceived barriers and enablers to enhancing fidelity of delivery of the proposed intervention. METHODS: An exploratory, qualitative study was conducted with GPs and chiropractors in NL. The interview guide was informed by the National Institutes of Health Behavior Change Consortium fidelity checklist; data analysis was guided by the Theoretical Domains Framework (TDF). Participant quotes were coded into TDF domains, belief statements were generated at each domain, and domains relevant to enhancing fidelity of provider training or intervention delivery were identified. RESULTS: The study included five GPs and five chiropractors from urban and rural settings. Barriers and enablers to enhancing fidelity to provider training related to seven TDF domains: [1] Beliefs about capabilities, [2] Optimism, [3] Reinforcement, [4] Memory, attention, and decision processes, [5] Environmental context and resources, [6] Emotion, and [7] Behavioural regulation. Barriers and enablers to enhancing fidelity to intervention delivery related to seven TDF domains: [1] Beliefs about capabilities, [2] Optimism, [3] Goals, [4] Memory, attention, and decision processes, [5] Environmental context and resources, [6] Social influences, and [7] Behavioural regulation. CONCLUSION: The largest perceived barrier to attending training was time; perceived enablers were incentives and flexible training. Patient pressure, time, and established habits were perceived barriers to delivering the intervention as intended. Participants suggested enhancement strategies to improve their ability to deliver the intervention as intended, including reminders and check-ins with researchers. Most participants perceived intervention fidelity as important. These results may aid in the development of a more feasible and pragmatic intervention to reduce non-indicated imaging for GPs and chiropractors in NL.

Strategies to Implement Pet Robots in Long-Term Care Facilities for Dementia Care: A Modified Delphi Study.

OBJECTIVES: Pet robots are technology-based substitutes for live animals that have demonstrated psychosocial benefits for people living with dementia in long-term care. However, little research has been conducted to understand how pet robots should be implemented in routine care. This study aims to identify, contextualize, and achieve expert consensus on strategies to implement pet robots as part of dementia care in long-term care facilities. DESIGN: A 2-round modified Delphi study. SETTINGS AND PARTICIPANTS: An international panel of 56 experts from 14 countries, involving care professionals, organizational leaders, and researchers. METHODS: A list of potentially relevant strategies was identified, contextualized, and revised using empirical data and through stakeholder consultations. These strategies constituted statements for Round 1. Experts rated the relative importance of each statement on a 9-point scale, and free-text fields allowed them to provide justifications. Consensus was predefined as ≥75% agreement. Statements not reaching an agreement were brought forward to Round 2. Quantitative data were analyzed using descriptive statistics, and textual data were analyzed using inductive content analysis. RESULTS: Thirteen strategies reached consensus; 11 were established as critical: (1) assess readiness and identify barriers and facilitators, (2) purposely reexamine the implementation, (3) obtain and use residents' and their family's feedback, (4) involve residents and their family, (5) promote adaptability, (6) conduct ongoing training, (7) conduct educational meetings, (8) conduct local consensus discussions, (9) organize clinician implementation team meetings, (10) provide local technical assistance, and (11) access new funding. Other strategies received differing extents of agreement. Reasons for variations included contextual differences, such as resource availability, organizational structures, and staff turnover. CONCLUSIONS AND IMPLICATIONS: This study identified the most relevant strategies that can be used by technology developers, care providers, and researchers to implement pet robots in long-term care facilities for dementia care. Further development, specification, and testing in real-world settings are needed.

Open science and conflict of interest policies of medical and health sciences journals before and during the COVID-19 pandemic: A repeat cross-sectional study: Open science policies of medical journals.

Objectives: To audit the transparent and open science standards of health and medical sciences journal policies and explore the impact of the COVID-19 pandemic. Design: Repeat cross-sectional study. Setting: 19 journals listed in Google Scholar's Top Publications for health and medical sciences. Participants: Blood, Cell, Circulation, European Heart Journal, Gastroenterology, Journal of Clinical Oncology, Journal of the American College of Cardiology, Nature Genetics, Nature Medicine, Nature Neuroscience, Neuron, PLoS ONE, Proceedings of the National Academy of Sciences, Science Translational Medicine, The British Medical Journal, The Journal of the American Medical Association, The Lancet, The Lancet Oncology, and The New England Journal of Medicine. Main outcome measures: We used the Transparency and Openness Promotion (TOP) guideline and the International Committee of Medical Journal Editors (ICMJE) requirements for disclosing conflicts of interest (COIs) to evaluate journals standards. Results: TOP scores slightly improved during the COVID-19 pandemic, from a median of 5 (IQR: 2-12.5) out of a possible 24 points in February 2020 to 7 (IQR: 4-12) in May 2021, but overall, scores were very low at both time points. Journal policies scored highest for their adherence to data transparency and scored lowest for preregistration of study protocols and analysis plans and the submission of replication studies. Most journals fulfilled all ICMJE provisions for reporting COIs before (84%; n = 16) and during (95%; n = 18) the COVID-19 pandemic. Conclusions: The COVID-19 pandemic has highlighted the importance of practising open science. However, requirements for open science practices in audited policies were overall low, which may impede progress in health and medical research. As key stakeholders in disseminating research, journals should promote a research culture of greater transparency and more robust open science practices.

Establishing open science research priorities in health psychology: a research prioritisation Delphi exercise.

OBJECTIVE: Research on Open Science practices in Health Psychology is lacking. This meta-research study aimed to identify research question priorities and obtain consensus on the Top 5 prioritised research questions for Open Science in Health Psychology. METHODS AND MEASURES: An international Delphi consensus study was conducted. Twenty-three experts in Open Science and Health Psychology within the European Health Psychology Society (EHPS) suggested research question priorities to create a 'long-list' of items (Phase 1). Forty-three EHPS members rated the importance of these items, ranked their top five and suggested their own additional items (Phase 2). Twenty-four EHPS members received feedback on Phase 2 responses and then re-rated and re-ranked their top five research questions (Phase 3). RESULTS: The top five ranked research question priorities were: 1. 'To what extent are Open Science behaviours currently practised in Health Psychology?', 2. 'How can we maximise the usefulness of Open Data and Open Code resources?', 3. 'How can Open Data be increased within Health Psychology?', 4. 'What interventions are effective for increasing the adoption of Open Science in Health Psychology?' and 5. 'How can we increase free Open Access publishing in Health Psychology?'. CONCLUSION: Funding and resources should prioritise the research questions identified here.

Feasibility of an Audit and Feedback Intervention to Facilitate Journal Policy Change Towards Greater Promotion of Transparency and Openness in Sports Science Research.

OBJECTIVES: To evaluate (1) the feasibility of an audit-feedback intervention to facilitate sports science journal policy change, (2) the reliability of the Transparency of Research Underpinning Social Intervention Tiers (TRUST) policy evaluation form, and (3) the extent to which policies of sports science journals support transparent and open research practices. METHODS: We conducted a cross-sectional, audit-feedback, feasibility study of transparency and openness standards of the top 38 sports science journals by impact factor. The TRUST form was used to evaluate journal policies support for transparent and open research practices. Feedback was provided to journal editors in the format of a tailored letter. Inter-rater reliability and agreement of the TRUST form was assessed using intraclass correlation coefficients and the standard error of measurement, respectively. Time-based criteria, fidelity of intervention delivery and qualitative feedback were used to determine feasibility. RESULTS: The audit-feedback intervention was feasible based on the time taken to rate journals and provide tailored feedback. The mean (SD) score on the TRUST form (range 0-27) was 2.05 (1.99), reflecting low engagement with transparent and open practices. Inter-rater reliability of the overall score of the TRUST form was moderate [ICC (2,1) = 0.68 (95% CI 0.55-0.79)], with standard error of measurement of 1.17. However, some individual items had poor reliability. CONCLUSION: Policies of the top 38 sports science journals have potential for improved support for transparent and open research practices. The feasible audit-feedback intervention developed here warrants large-scale evaluation as a means to facilitate change in journal policies. REGISTRATION: OSF ( https://osf.io/d2t4s/ ).

Priority III: top 10 rapid review methodology research priorities identified using a James Lind Alliance Priority Setting Partnership.

OBJECTIVES: A rapid review is a form of evidence synthesis considered a resource-efficient alternative to the conventional systematic review. Despite a dramatic rise in the number of rapid reviews commissioned and conducted in response to the coronavirus disease 2019 pandemic, published evidence on the optimal methods of planning, doing, and sharing the results of these reviews is lacking. The Priority III study aimed to identify the top 10 unanswered questions on rapid review methodology to be addressed by future research. STUDY DESIGN AND SETTING: A modified James Lind Alliance Priority Setting Partnership approach was adopted. This approach used two online surveys and a virtual prioritization workshop with patients and the public, reviewers, researchers, clinicians, policymakers, and funders to identify and prioritize unanswered questions. RESULTS: Patients and the public, researchers, reviewers, clinicians, policymakers, and funders identified and prioritized the top 10 unanswered research questions about rapid review methodology. Priorities were identified throughout the entire review process, from stakeholder involvement and formulating the question, to the methods of a systematic review that are appropriate to use, through to the dissemination of results. CONCLUSION: The results of the Priority III study will inform the future research agenda on rapid review methodology. We hope this will enhance the quality of evidence produced by rapid reviews, which will ultimately inform decision-making in the context of healthcare.

Strategies for implementing pet robots in care homes and nursing homes for residents with dementia: protocol for a modified Delphi study.

BACKGROUND: Pet robots are a type of technology-based innovation that have shown positive psychosocial benefits for people with dementia in residential facilities, such as improving mood and social interaction and reducing agitation. Nevertheless, little is known about how pet robots can be implemented in care homes and nursing homes for dementia care in real-world practice. The objectives of this study are to (1) identify contextualised implementation strategies for implementing pet robots into care homes and nursing homes for dementia care and (2) achieve consensus on the most relevant strategies. METHOD: This study is informed by a preceding scoping review and qualitative study, which used the Consolidated Framework of Implementation Research (CFIR) to identify multi-level determinants of implementation (i.e. barriers and facilitators). We will use the CFIR-ERIC matching tool to identify relevant implementation strategies from the Expert Recommendations for Implementing Change (ERIC) taxonomy to address these determinants. Data from the scoping review and qualitative study will be used to contextualise the generic ERIC strategies for our setting. After that, a group of key stakeholders will be consulted to further contextualise and refine these strategies. Next, a two-round modified Delphi process will be conducted. Fifty-four international expert participants including healthcare professionals and organisational leaders from care homes and nursing homes and academic researchers will be recruited through purposive sampling. During the first Delphi round, participants will be invited to rate the relevance of each implementation strategy on a 9-point Likert scale and provide comments or suggestions. Descriptive statistics will be used to identify whether consensus has been obtained. Inductive qualitative content analysis will be used to analyse and summarise textual responses for any new statements suggested by participants. Statements that do not reach consensus and new statements suggested in round 1 will be taken to the next round, which will follow the same rating process. DISCUSSION: This study will identify strategies for implementing pet robots in care homes and nursing homes for residents with dementia, which will have practical utility for clinicians, organisations and researchers. It will also demonstrate the practical application (and adaptation) of the CFIR-ERIC tool to identify and contextualise ERIC strategies.

Determinants of implementing of pet robots in nursing homes for dementia care.

BACKGROUND: Pet robots have been employed as viable substitutes to pet therapy in nursing homes. Despite their potential to enhance the psychosocial health of residents with dementia, there is a lack of studies that have investigated determinants of implementing pet robots in real-world practice. This study aims to explore the determinants of implementing pet robots for dementia care in nursing homes, from the perspectives of healthcare professionals and organisational leaders. METHODS: A descriptive qualitative study, conceptualised and guided using the Consolidated Framework of Implementation Research (CFIR), was conducted. We conducted semi-structured interviews with healthcare professionals and organisational leaders from nursing homes. Data was transcribed and analysed using Framework Analysis, based on the CFIR as an a priori framework. RESULTS: A total of 22 participants from eight nursing homes were included. Determinants were mapped to constructs from all five CFIR domains. Determinants relating to the characteristics of pet robots include their design, realisticness and interactivity, affordability, cleanability, perceived evidence strength and comparative advantages to live pets. Determinants relating to external influences (outer setting) include national regulatory guidelines, funding and networks with other organisations. With regards to characteristics of nursing homes (inner setting), determinants include the relevance of pet robots in relation to the needs of residents with dementia, alignment with care processes, infection control mandates and their relative priority. In the domain 'characteristics of individuals', determinants were associated with individuals' beliefs on the role of technology, desires to enhance residents' quality of life, and differential attitudes on the use of robots. Finally, in the domain 'implementation process', assessments and care planning were identified as determinants. CONCLUSIONS: Overall, while sentiments around determinants within CFIR domains of pet robots' characteristics, outer setting and implementation process were similar, participants' opinions on the determinants within the 'inner setting' and 'characteristics of individuals' were more varied. This could be due to different organisational structures, disciplinary differences and personal experiences of using pet robots. Many determinants in different domains were interrelated. Findings provide a springboard for identifying and designing implementation strategies to guide the translation of pet robots from research into real-world practice.

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 internationally.

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.

Using behavioural science to enhance use of core outcome sets in trials: protocol.

Background: Core outcome sets (COS) represent agreed-upon sets of outcomes, which are the minimum that should be measured and reported in all trials in specific health areas. Use of COS can reduce outcome heterogeneity, selective outcome reporting, and research waste, and can facilitate evidence syntheses. Despite benefits of using COS, current use of COS in trials is low. COS use can be understood as a behaviour, in that it is something trialists do, or not do, adequately. The aim of this study is to identify strategies, informed by behaviour change theory, to increase COS use in trials. Methods: The project will be conducted in two stages, informed by the behaviour change wheel (BCW). The BCW is a theoretically based framework that can be used to classify, identify, and develop behaviour change strategies. In Stage 1, barriers and enablers to COS use will be extracted from published studies that examined trialist's use of COS. Barriers and facilitators will be mapped to the components of COM-B model (capability, opportunity, and motivation), which forms part of the BCW framework. Stage 2 will build on Stage 1 findings to identify and select intervention functions and behaviour change techniques to enhance COS use in trials. Discussion: The findings of this study will provide an understanding of the behavioural factors that influence COS use in trials and what strategies might be used to target these factors to increase COS use in trials.

Enhancing the translation of health behaviour change research into practice: a selective conceptual review of the synergy between implementation science and health psychology.

Health psychology is at the forefront of developing and disseminating evidence, theories, and methods that have improved the understanding of health behaviour change. However, current dissemination approaches may be insufficient for promoting broader application and impact of this evidence to benefit the health of patients and the public. Nevertheless, behaviour change theory/methods typically directed towards health behaviours are now used in implementation science to understand and support behaviour change in individuals at different health system levels whose own behaviour impacts delivering evidence-based health behaviour change interventions. Despite contributing to implementation science, health psychology is perhaps doing less to draw from it. A redoubled focus on implementation science in health psychology could provide novel prospects for enhancing the impact of health behaviour change evidence. We report a Health Psychology Review-specific review-of-reviews of trials of health behaviour change interventions published from inception to April 2020. We identified 34 reviews and assessed whether implementation readiness of behaviour change interventions was discussed. We then narratively review how implementation science has integrated theory/methods from health psychology and related discipline. Finally, we demonstrate how greater synergy between implementation science and health psychology could promote greater follow-through on advances made in the science of health behaviour change.

Prioritising Informed Health Choices Key Concepts for those impacted by cancer: a protocol.

Background: Few areas of health have been as insidiously influenced by misinformation as cancer. Thus, interventions that can help people impacted by cancer reduce the extent to which they are victims of misinformation are necessary. The Informed Health Choices (IHC) initiative has developed Key Concepts that can be used in the development of interventions for evaluating the trustworthiness of claims about the effects of health treatments. We are developing an online education programme called Informed Health Choices-Cancer (IHC-C) based on the IHC Key Concepts. We will provide those impacted by cancer with the knowledge and skills necessary to think critically about the reliability of health information and claims and make informed choices. Methods: We will establish a steering group (SG) of 12 key stakeholders, including oncology specialists and academics. In addition, we will establish a patient and public involvement (PPI) panel of 20 people impacted by cancer. After training the members on the Key Concepts and the prioritisation process, we will conduct a two-round prioritisation process. In the first round, 12 SG members and four PPI panel members will prioritise Key Concepts for inclusion. In the second round, the remaining 16 PPI members will undertake the prioritisation based on the prioritised Key Concepts from the first round. Participants in both rounds will use a structured judgement form to rate the importance of the Key Concepts for inclusion in the online IHC-C programme. A consensus meeting will be held, where members will reach a consensus on the Key Concepts to be included and rank the order in which the prioritised Key Concepts will be addressed in the IHC-C programme. Conclusions: At the end of this process, we will identify which Key Concepts should be included and the order in which they should be addressed in the IHC-C programme.

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.