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1.
Artigo em Inglês | MEDLINE | ID: mdl-34415351

RESUMO

BACKGROUND: Intradialytic exercise (IDE) may improve physical function and health-related quality of life. However, incorporating IDE into standard hemodialysis care has been slow due to feasibility challenges. We conducted a multicenter qualitative feasibility study to identify potential barriers and enablers to IDE and generate potential solutions to these factors. METHODS: We conducted 43 semi-structured interviews with healthcare providers and patients across twelve hospitals in Ontario, Canada. We used the Theoretical Domains Framework and directed content analysis to analyze the data. RESULTS: We identified eight relevant domains (knowledge, skills, beliefs about consequences, beliefs about capabilities, environmental context and resources, goals, social/professional role and identity, and social influences) represented by three overarching categories: 1) Knowledge, skills and expectations: lack of staff expertise to oversee exercise, uncertainty regarding exercise risks, benefits, and patient interest, lack of knowledge regarding exercise eligibility; 2) Human, material and logistical resources: staff concerns regarding workload, perception that exercise professionals should supervise IDE; space, equipment, and scheduling conflict concerns; 3) Social dynamics of the unit: local champions and patient stories contribute to IDE sustainability.We developed a list of actionable solutions by mapping barriers and enablers to behavior change techniques. We also developed a feasibility checklist of 47 questions identifying key factors to address prior to IDE launch. CONCLUSIONS: Evidence-based solutions to identified barriers and enablers to IDE and a feasibility checklist may help recruit and support units, staff, and patients and address key challenges to the delivery of IDE in diverse clinical and research settings.

2.
Int J Equity Health ; 20(1): 187, 2021 08 21.
Artigo em Inglês | MEDLINE | ID: mdl-34419053

RESUMO

Intersectionality is a widely adopted theoretical orientation in the field of women and gender studies. Intersectionality comes from the work of black feminist scholars and activists. Intersectionality argues identities such as gender, race, sexuality, and other markers of difference intersect and reflect large social structures of oppression and privilege, such as sexism, racism, and heteronormativity. The reach of intersectionality now extends to the fields of public health and knowledge translation. Knowledge translation (KT) is a field of study and practice that aims to synthesize and evaluate research into an evidence base and move that evidence into health care practice. There have been increasing calls to bring gender and other social issues into the field of KT. Yet, as scholars outline, there are few guidelines for incorporating the principles of intersectionality into empirical research. An interdisciplinary, team-based, national health research project in Canada aimed to bring an intersectional lens to the field of knowledge translation. This paper reports on key moments and resulting tensions we experienced through the project, which reflect debates in intersectionality: discomfort with social justice, disciplinary divides, and tokenism. We consider how our project advances intersectionality practice and suggests recommendations for using intersectionality in health research contexts. We argue that while we encountered many challenges, our process and the resulting co-created tools can serve as a valuable starting point and example of how intersectionality can transform fields and practices.


Assuntos
Equidade em Saúde , Colaboração Intersetorial , Racismo , Pesquisa Médica Translacional , Afro-Americanos , Feminino , Feminilidade , Feminismo , Humanos , Pesquisa Interdisciplinar , Justiça Social
3.
Implement Sci ; 16(1): 81, 2021 08 17.
Artigo em Inglês | MEDLINE | ID: mdl-34404449

RESUMO

BACKGROUND: Healthcare Audit and Feedback (A&F) interventions have been shown to be an effective means of changing healthcare professional behavior, but work is required to optimize them, as evidence suggests that A&F interventions are not improving over time. Recent published guidance has suggested an initial set of best practices that may help to increase intervention effectiveness, which focus on the "Nature of the desired action," "Nature of the data available for feedback," "Feedback display," and "Delivering the feedback intervention." We aimed to develop a generalizable evaluation tool that can be used to assess whether A&F interventions conform to these suggestions for best practice and conducted initial testing of the tool through application to a sample of critical care A&F interventions. METHODS: We used a consensus-based approach to develop an evaluation tool from published guidance and subsequently applied the tool to conduct a secondary analysis of A&F interventions. To start, the 15 suggestions for improved feedback interventions published by Brehaut et al. were deconstructed into rateable items. Items were developed through iterative consensus meetings among researchers. These items were then piloted on 12 A&F studies (two reviewers met for consensus each time after independently applying the tool to four A&F intervention studies). After each consensus meeting, items were modified to improve clarity and specificity, and to help increase the reliability between coders. We then assessed the conformity to best practices of 17 critical care A&F interventions, sourced from a systematic review of A&F interventions on provider ordering of laboratory tests and transfusions in the critical care setting. Data for each criteria item was extracted by one coder and confirmed by a second; results were then aggregated and presented graphically or in a table and described narratively. RESULTS: In total, 52 criteria items were developed (38 ratable items and 14 descriptive items). Eight studies targeted lab test ordering behaviors, and 10 studies targeted blood transfusion ordering. Items focused on specifying the "Nature of the Desired Action" were adhered to most commonly-feedback was often presented in the context of an external priority (13/17), showed or described a discrepancy in performance (14/17), and in all cases it was reasonable for the recipients to be responsible for the change in behavior (17/17). Items focused on the "Nature of the Data Available for Feedback" were adhered to less often-only some interventions provided individual (5/17) or patient-level data (5/17), and few included aspirational comparators (2/17), or justifications for specificity of feedback (4/17), choice of comparator (0/9) or the interval between reports (3/13). Items focused on the "Nature of the Feedback Display" were reported poorly-just under half of interventions reported providing feedback in more than one way (8/17) and interventions rarely included pilot-testing of the feedback (1/17 unclear) or presentation of a visual display and summary message in close proximity of each other (1/13). Items focused on "Delivering the Feedback Intervention" were also poorly reported-feedback rarely reported use of barrier/enabler assessments (0/17), involved target members in the development of the feedback (0/17), or involved explicit design to be received and discussed in a social context (3/17); however, most interventions clearly indicated who was providing the feedback (11/17), involved a facilitator (8/12) or involved engaging in self-assessment around the target behavior prior to receipt of feedback (12/17). CONCLUSIONS: Many of the theory-informed best practice items were not consistently applied in critical care and can suggest clear ways to improve interventions. Standardized reporting of detailed intervention descriptions and feedback templates may also help to further advance research in this field. The 52-item tool can serve as a basis for reliably assessing concordance with best practice guidance in existing A&F interventions trialed in other healthcare settings, and could be used to inform future A&F intervention development. TRIAL REGISTRATION: Not applicable.

4.
BMJ Open ; 11(8): e046707, 2021 08 12.
Artigo em Inglês | MEDLINE | ID: mdl-34385243

RESUMO

INTRODUCTION: Chimeric antigen receptor T-cell (CAR-T) therapy is a class of immunotherapy. An economic evaluation conducted at an early stage of development of CAR-T therapy for treatment of adult relapsed or refractory acute lymphoblastic leukaemia could provide insight into factors contributing to the cost of treatment, the potential clinical benefits, and what the health system can afford. Traditionally, stakeholders are engaged in certain parts of health technology assessment processes, such as in the identification and selection of technologies, formulation of recommendations, and implementation of recommendations; however, little is known about processes for stakeholder engagement during the conduct of the assessment. This is especially the case for economic evaluations. Stakeholders, such as clinicians, policy-makers, patients, and their support networks, have insight into factors that can enhance the validity of an economic evaluation model. This research outlines a specific methodology for stakeholder engagement and represents an avenue to enhance health economic evaluations and support the use of these models to inform decision making for resource allocation. This protocol may inform a tailored framework for stakeholder engagement processes in future economic evaluation model development. METHODS AND ANALYSIS: We will involve clinicians, healthcare researchers, payers, and policy-makers, as well as patients and their support networks in the conduct and verification of an early economic evaluation of a novel health technology to incorporate stakeholder-generated knowledge. Three stakeholder-specific focus groups will be conducted using an online adaptation of the nominal group technique to elicit considerations from each. This study will use CAR-T therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukaemia as a basis for investigating broader stakeholder engagement processes. ETHICS AND DISSEMINATION: This study received ethics approval from the Ottawa Hospital Research Institute Research Ethics Board (REB 20200320-01HT) and the results will be shared via conference presentations, peer-reviewed publications, and ongoing stakeholder engagement.


Assuntos
Imunoterapia Adotiva , Receptores de Antígenos Quiméricos , Adulto , Terapia Baseada em Transplante de Células e Tecidos , Análise Custo-Benefício , Pessoal de Saúde , Humanos , Participação dos Interessados
6.
EBioMedicine ; 70: 103484, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34280783

RESUMO

BACKGROUND: 'Patient engagement' involves meaningful collaboration between researchers and 'patient partners' to co-create research. It helps ensure that research being conducted is relevant to its ultimate end-users. Although patient engagement within clinical research has been well documented, the prevalence and effects of patient engagement in translational preclinical laboratory research remain unclear. The aim of this scoping review is to present current patient engagement activities reported in preclinical laboratory research. METHODS: MEDLINE, Embase, and grey literature were systematically searched from inception to April 2021. Studies that described or investigated patient engagement in preclinical laboratory research were included. Patient engagement activities where patients (i.e. patients, family members, caregivers or community members) provided input, or consultation on at least one element of the research process were eligible for inclusion. Study characteristics and outcomes were extracted and organized thematically. FINDINGS: 32 reports were included (30 primary studies, 1 narrative review, and 1 researcher guide). Most studies engaged patients at the education or priority setting stages (n=26). The most frequently reported benefit of patient engagement was 'providing a mutual learning opportunity'. Reported barriers to patient engagement reflected concerns around 'differences in knowledge and research experience' and how this may challenge communication and limit meaningful collaboration. INTERPRETATION: Patient engagement is feasible and beneficial for preclinical laboratory research. Future work should focus on assessing the impacts of patient engagement in this area of research. FUNDING: None.

7.
Curr Oncol ; 28(3): 2014-2028, 2021 05 26.
Artigo em Inglês | MEDLINE | ID: mdl-34073279

RESUMO

BACKGROUND: Ensuring adequate, informed, and timely participation in clinical trials is a multifactorial problem. We have previously developed a systematic, tailorable survey development approach that is informed by theory, can identify barriers and enablers to participation, and can suggest recruitment strategies to address these issues. In this study, we surveyed subscribers to the Canadian Breast Cancer Network (CBCN) in order to identify a comprehensive list of theory-informed barriers and enablers relevant to participation in a hypothetical breast cancer trial. METHODS: We developed and conducted an online survey of breast cancer patients informed by the Theoretical Domains Framework and designed to determine previous experience with clinical trials, knowledge about clinical trials, and importance of a comprehensive list of barriers and enablers to trial participation. Participants were contacted by email or through social media. RESULTS: From 2451 subscribers of the CBCN, we received 244 responses and 210 completed surveys (244/2451 or 9.9% participation, 210/244 or 86.1% completion). A total of 38% of respondents indicated experience in trial participation, but 83% indicated confidence in their knowledge about clinical trials. Those who had previously participated in clinical trials were more confident in their knowledge (χ2= 6.77, p = 0.009) and answered more knowledge questions (t = -3.90 p = 0.000). Endorsed barriers and enablers to participation included 39 factors across 12 of 14 domains relevant to behaviour change. Our approach identifies barriers that might be meaningfully addressed by careful knowledge provision ('If I would learn more about my condition'; 'If I find the trial documents hard to understand'), those that may require other theory-informed approaches to address ('my feelings about the quality of my drug plan'; 'my worry over unknown side effects'), and those that may require tailored approaches depending on participant differences such as previous experience in trials ('If there were patient-friendly decision-making tools to help you make your participation decision'). DISCUSSION: This work demonstrates that a comprehensive, theory-guided survey of barriers and enablers to participation in breast cancer clinical trials is feasible, can lead to detailed knowledge about the issues related to participation in specific trials, and most importantly, can lead to insights about evidence-based ways to better support patient participation.


Assuntos
Neoplasias da Mama , Ensaios Clínicos como Assunto , Neoplasias da Mama/terapia , Canadá , Feminino , Humanos , Participação do Paciente , Inquéritos e Questionários
8.
JMIR Res Protoc ; 10(6): e24887, 2021 Jun 11.
Artigo em Inglês | MEDLINE | ID: mdl-34114962

RESUMO

BACKGROUND: Health behaviors such as physical inactivity, unhealthy eating, smoking tobacco, and alcohol use are leading risk factors for noncommunicable chronic diseases and play a central role in limiting health and life satisfaction. To date, however, health behaviors tend to be considered separately from one another, resulting in guidelines and interventions for healthy aging siloed by specific behaviors and often focused only on a given health behavior without considering the co-occurrence of family, social, work, and other behaviors of everyday life. OBJECTIVE: The aim of this study is to understand how behaviors cluster and how such clusters are associated with physical and mental health, life satisfaction, and health care utilization may provide opportunities to leverage this co-occurrence to develop and evaluate interventions to promote multiple health behavior changes. METHODS: Using cross-sectional baseline data from the Canadian Longitudinal Study on Aging, we will perform a predefined set of exploratory and hypothesis-generating analyses to examine the co-occurrence of health and everyday life behaviors. We will use agglomerative hierarchical cluster analysis to cluster individuals based on their behavioral tendencies. Multinomial logistic regression will then be used to model the relationships between clusters and demographic indicators, health care utilization, and general health and life satisfaction, and assess whether sex and age moderate these relationships. In addition, we will conduct network community detection analysis using the clique percolation algorithm to detect overlapping communities of behaviors based on the strength of relationships between variables. RESULTS: Baseline data for the Canadian Longitudinal Study on Aging were collected from 51,338 participants aged between 45 and 85 years. Data were collected between 2010 and 2015. Secondary data analysis for this project was approved by the Ottawa Health Science Network Research Ethics Board (protocol ID #20190506-01H). CONCLUSIONS: This study will help to inform the development of interventions tailored to subpopulations of adults (eg, physically inactive smokers) defined by the multiple behaviors that describe their everyday life experiences. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24887.

9.
Cochrane Database Syst Rev ; 5: CD012932, 2021 05 31.
Artigo em Inglês | MEDLINE | ID: mdl-34057201

RESUMO

BACKGROUND: Social networking platforms offer a wide reach for public health interventions allowing communication with broad audiences using tools that are generally free and straightforward to use and may be combined with other components, such as public health policies. We define interactive social media as activities, practices, or behaviours among communities of people who have gathered online to interactively share information, knowledge, and opinions. OBJECTIVES: We aimed to assess the effectiveness of interactive social media interventions, in which adults are able to communicate directly with each other, on changing health behaviours, body functions, psychological health, well-being, and adverse effects. Our secondary objective was to assess the effects of these interventions on the health of populations who experience health inequity as defined by PROGRESS-Plus. We assessed whether there is evidence about PROGRESS-Plus populations being included in studies and whether results are analysed across any of these characteristics. SEARCH METHODS: We searched CENTRAL, CINAHL, Embase, MEDLINE (including trial registries) and PsycINFO. We used Google, Web of Science, and relevant web sites to identify additional studies and searched reference lists of included studies. We searched for published and unpublished studies from 2001 until June 1, 2020. We did not limit results by language. SELECTION CRITERIA: We included randomised controlled trials (RCTs), controlled before-and-after (CBAs) and interrupted time series studies (ITSs). We included studies in which the intervention website, app, or social media platform described a goal of changing a health behaviour, or included a behaviour change technique. The social media intervention had to be delivered to adults via a commonly-used social media platform or one that mimicked a commonly-used platform. We included studies comparing an interactive social media intervention alone or as a component of a multi-component intervention with either a non-interactive social media control or an active but less-interactive social media comparator (e.g. a moderated versus an unmoderated discussion group). Our main outcomes were health behaviours (e.g. physical activity), body function outcomes (e.g. blood glucose), psychological health outcomes (e.g. depression), well-being, and adverse events. Our secondary outcomes were process outcomes important for behaviour change and included knowledge, attitudes, intention and motivation, perceived susceptibility, self-efficacy, and social support. DATA COLLECTION AND ANALYSIS: We used a pre-tested data extraction form and collected data independently, in duplicate. Because we aimed to assess broad outcomes, we extracted only one outcome per main and secondary outcome categories prioritised by those that were the primary outcome as reported by the study authors, used in a sample size calculation, and patient-important. MAIN RESULTS: We included 88 studies (871,378 participants), of which 84 were RCTs, three were CBAs and one was an ITS. The majority of the studies were conducted in the USA (54%). In total, 86% were conducted in high-income countries and the remaining 14% in upper middle-income countries. The most commonly used social media platform was Facebook (39%) with few studies utilising other platforms such as WeChat, Twitter, WhatsApp, and Google Hangouts. Many studies (48%) used web-based communities or apps that mimic functions of these well-known social media platforms. We compared studies assessing interactive social media interventions with non-interactive social media interventions, which included paper-based or in-person interventions or no intervention. We only reported the RCT results in our 'Summary of findings' table. We found a range of effects on health behaviours, such as breastfeeding, condom use, diet quality, medication adherence, medical screening and testing, physical activity, tobacco use, and vaccination. For example, these interventions may increase physical activity and medical screening tests but there was little to no effect for other health behaviours, such as improved diet or reduced tobacco use (20,139 participants in 54 RCTs). For body function outcomes, interactive social media interventions may result in small but important positive effects, such as a small but important positive effect on weight loss and a small but important reduction in resting heart rate (4521 participants in 30 RCTs). Interactive social media may improve overall well-being (standardised mean difference (SMD) 0.46, 95% confidence interval (CI) 0.14 to 0.79, moderate effect, low-certainty evidence) demonstrated by an increase of 3.77 points on a general well-being scale (from 1.15 to 6.48 points higher) where scores range from 14 to 70 (3792 participants in 16 studies). We found no difference in effect on psychological outcomes (depression and distress) representing a difference of 0.1 points on a standard scale in which scores range from 0 to 63 points (SMD -0.01, 95% CI -0.14 to 0.12, low-certainty evidence, 2070 participants in 12 RCTs). We also compared studies assessing interactive social media interventions with those with an active but less interactive social media control (11 studies). Four RCTs (1523 participants) that reported on physical activity found an improvement demonstrated by an increase of 28 minutes of moderate-to-vigorous physical activity per week (from 10 to 47 minutes more, SMD 0.35, 95% CI 0.12 to 0.59, small effect, very low-certainty evidence). Two studies found little to no difference in well-being for those in the intervention and control groups (SMD 0.02, 95% CI -0.08 to 0.13, small effect, low-certainty evidence), demonstrated by a mean change of 0.4 points on a scale with a range of 0 to 100. Adverse events related to the social media component of the interventions, such as privacy issues, were not reported in any of our included studies. We were unable to conduct planned subgroup analyses related to health equity as only four studies reported relevant data. AUTHORS' CONCLUSIONS: This review combined data for a variety of outcomes and found that social media interventions that aim to increase physical activity may be effective and social media interventions may improve well-being. While we assessed many other outcomes, there were too few studies to compare or, where there were studies, the evidence was uncertain. None of our included studies reported adverse effects related to the social media component of the intervention. Future studies should assess adverse events related to the interactive social media component and should report on population characteristics to increase our understanding of the potential effect of these interventions on reducing health inequities.


Assuntos
Terapia Comportamental/métodos , Comportamentos Relacionados com a Saúde , Equidade em Saúde , Mídias Sociais , Rede Social , Adolescente , Adulto , Viés , Estudos Controlados Antes e Depois , Exercício Físico , Frutas , Frequência Cardíaca , Humanos , Análise de Séries Temporais Interrompida , Ensaios Clínicos Controlados Aleatórios como Assunto , Resultado do Tratamento , Verduras , Perda de Peso , Adulto Jovem
10.
Trials ; 22(1): 298, 2021 Apr 21.
Artigo em Inglês | MEDLINE | ID: mdl-33883012

RESUMO

BACKGROUND: Clinical trial recruitment is a continuing challenge for medical researchers. Previous efforts to improve study recruitment have rarely been informed by theories of human decision making and behavior change. We investigate the trial recruitment strategies reported by study recruiters, guided by two influential theoretical frameworks: shared decision-making (SDM) and the Theoretical Domains Framework (TDF) in order to explore the utility of these frameworks in trial recruitment. METHODS: We interviewed all nine active study recruiters from a multi-site, open-label pilot trial assessing the feasibility of a large-scale randomized trial. Recruiters were primarily nurses or master's-level research assistants with a range of 3 to 30 years of experience. The semi-structured interviews included questions about the typical recruitment encounter, questions concerning the main components of SDM (e.g. verifying understanding, directive vs. non-directive style), and questions investigating the barriers to and drivers of their recruitment activities, based on the TDF. We used directed content analysis to code quotations into TDF domains, followed by inductive thematic analysis to code quotations into sub-themes within domains and overarching themes across TDF domains. Responses to questions related to SDM were aggregated according to level of endorsement and informed the thematic analysis. RESULTS: The analysis helped to identify 28 sub-themes across 11 domains. The sub-themes were organized into six overarching themes: coordinating between people, providing guidance to recruiters about challenges, providing resources to recruiters, optimizing study flow, guiding the recruitment decision, and emphasizing the benefits to participation. The SDM analysis revealed recruiters were able to view recruitment interactions as successful even when enrollment did not proceed, and most recruiters took a non-directive (i.e. providing patients with balanced information on available options) or mixed approach over a directive approach (i.e. focus on enrolling patient in study). Most of the core SDM constructs were frequently endorsed. CONCLUSIONS: Identified sub-themes can be linked to TDF domains for which effective behavior change interventions are known, yielding interventions that can be evaluated as to whether they improve recruitment. Despite having no formal training in shared decision-making, study recruiters reported practices consistent with many elements of SDM. The development of SDM training materials specific to trial recruitment could improve the informed decision-making process for patients.


Assuntos
Tomada de Decisão Compartilhada , Tomada de Decisões , Pessoal de Saúde , Humanos , Participação do Paciente
11.
Clin Trials ; 18(4): 398-407, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33863242

RESUMO

BACKGROUND: Recruitment and engagement of clusters in a cluster randomized controlled trial can sometimes prove challenging. Identification of successful or unsuccessful strategies may be beneficial in guiding future researchers in conducting their cluster randomized controlled trial. This study aimed to identify strategies that could be used to facilitate the delivery of cluster randomized controlled trials in hospitals. METHODS: The study employed the Consolidated Framework for Implementation Research-Expert Recommendations for Implementing Change matching tool. The barriers and enablers to cluster randomized controlled trial conduct identified in our previously conducted studies served as a means of determinant identification for the conduct of cluster randomized controlled trials. These determinants were mapped to Consolidated Framework for Implementation Research constructs and then matched to Expert Recommendations for Implementing Change compilation strategies using the Consolidated Framework for Implementation Research-Expert Recommendations for Implementing Change matching tool. RESULTS: The Expert Recommendations for Implementing Change strategies matched to at least one determinant Consolidated Framework for Implementation Research construct were as follows: (1) 'Identify and prepare champions', (2) 'Conduct local needs assessment', (3) 'Conduct educational meetings', (4) 'Inform local opinion leaders', (5) 'Build a coalition', (6) 'Promote adaptability', (7) 'Develop a formal implementation blueprint', (8) 'Involve patients/consumers and family members', (9) 'Obtain and use patients/consumers and family feedback', (10) 'Develop educational materials', (11) 'Promote network weaving', (12) 'Distribute educational materials', (13) 'Access new funding' and (14) 'Develop academic partnerships'. CONCLUSION: This study was intended as a step in the research agenda aimed at facilitating cluster randomized controlled trial delivery in hospitals and can act as a resource for future researchers when planning their cluster randomized controlled trial, with the expectation that the strategies identified here will be tailored to each context.

12.
J Clin Epidemiol ; 137: 1-13, 2021 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-33727134

RESUMO

OBJECTIVES: To use the Theoretical Domains Framework (TDF) to identify barriers and enablers to participant retention in trials requiring questionnaire return and/or attendance at follow-up clinics. STUDY DESIGN AND SETTING: We invited participants (n = 607) from five pragmatic effectiveness trials, who missed at least one follow-up time point (by not returning a questionnaire and/or not attending a clinic visit), to take part in semistructured telephone interviews. The TDF informed both data collection and analysis. To establish what barriers and enablers most likely influence the target behavior the domain relevance threshold was set at >75% of participants mentioning the domain. RESULTS: Sixteen participants (out of 25 showing interest) were interviewed. Overall, seven theoretical domains were identified as both barriers and enablers to the target behaviors of attending clinic appointments and returning postal questionnaires. Barriers frequently reported in relation to both target behaviours stemmed from participants' knowledge, beliefs about their capabilities and the consequences of performing (or not performing) the behavior. Two domains were identified as salient for questionnaire return only: goals; and memory, attention and decision-making. Emotion was identified as relevant for clinic attendance only. CONCLUSION: This is the first study informed by behavioural science to explore trial participants' accounts of trial retention. Findings will serve as a guiding framework when designing trials to limit barriers and enhance enablers of retention within clinical trials.

13.
Pilot Feasibility Stud ; 7(1): 75, 2021 Mar 19.
Artigo em Inglês | MEDLINE | ID: mdl-33741062

RESUMO

BACKGROUND: The consumption of resistant starches is a promising adjuvant therapy for patients with inflammatory bowel disease. Rigorous evaluation of resistant starches in this setting depends on the intervention being delivered, received, and enacted as intended, that is, with fidelity. As part of a planned pilot trial, participants will be randomized to ingest resistant starches or a placebo. They will also be asked to collect stool samples and keep symptom and dose diaries to inform trial outcomes. We aim to identify potential factors impacting fidelity to the receipt and enactment of trial intervention and data collection activities from the perspective of patients and caregivers in the trial. Identifying fidelity barriers and enablers at the pilot trial phase of a clinical intervention may help to determine optimization processes when expanding to multiple sites in future trials. METHODS: We will conduct 15-30 semi-structured interviews with pilot trial participants (aged 8-17) and their caregivers. Trial participants will be approached for interviews approximately 6 months after the start of their trial participation. Personal projects analysis, a tool for understanding how individuals manage competing demands in their daily lives, will guide an in-depth exploration of how trial participants engage in activities related to intervention and data collection fidelity (ingesting resistant starches or placebo, collecting stool samples, keeping a symptom and dose diary) amidst the complexities of daily living. DISCUSSION: The present study will seek to explore and demonstrate how theory-informed fidelity assessments can be conducted alongside pilot trials to inform future multisite trials. Study results will clarify what factors may affect fidelity to trial intervention and data collection activities. Results may suggest what to modify to optimize the design and conduct, and ensure the integrity, of future multisite trials. Conducting process evaluations alongside clinical trials has the potential to improve our understanding of trial participant experiences. Results will provide a better understanding of how trial participants manage to engage in necessary trial activities along with other priorities.

14.
BMJ Open ; 11(3): e043929, 2021 03 19.
Artigo em Inglês | MEDLINE | ID: mdl-33741670

RESUMO

OBJECTIVES: Bench to bedside translation of groundbreaking treatments like chimeric antigen receptor T (CAR-T) cell therapy depends on patient participation in early phase trials. Unfortunately, many novel therapies fail to be adequately evaluated due to low recruitment rates, which slows patient access to emerging treatments. Using the Theoretical Domains Framework (TDF), we sought to identify potential patient barriers and enablers to participating in an early phase CAR-T cell therapy trial. DESIGN: We used qualitative semistructured interviews to identify potential barriers and enablers to patients' hypothetical participation in an early phase CAR-T cell therapy trial. We used the TDF and directed content analysis to identify relevant domains based on frequency, relevance and the presence of conflicting beliefs. PARTICIPANTS: Canadian adult patients diagnosed with haematological malignancies. RESULTS: In total, we interviewed 13 participants (8 women, 5 men). Participants ranged in age from 18 to 73 (median=56) and had been living with haematological cancer from a few months to several years. We found participants were unfamiliar with CAR-T cell therapy but wished to know more about treatment safety, efficacy and trial logistics (domains: knowledge, beliefs about consequences). They were motivated by altruistic considerations, though many prioritised personal health benefits despite recognising the goals (ie, establishing safety) of early phase clinical trials (domains: goals, intentions). Every participant valued receiving medical advice from their haematologists and oncologists, though some preferred impartial medical experts to inform their decision making (domain: social influences). Finally, participants indicated that improving access to financial and social supports would improve their trial participation experience (domain: environmental context and resources). CONCLUSION: Using the TDF allowed us to identify factors that might undermine participation to a CAR-T cell therapy trial and to optimise recruitment processes by considering patient perspectives to taking part in early phase trials.Trial regestration: NCT03765177; Pre-results.


Assuntos
Receptores de Antígenos Quiméricos , Adulto , Canadá , Terapia Baseada em Transplante de Células e Tecidos , Pré-Escolar , Feminino , Humanos , Masculino , Participação do Paciente , Incerteza
15.
Trials ; 22(1): 230, 2021 Mar 25.
Artigo em Inglês | MEDLINE | ID: mdl-33766105

RESUMO

BACKGROUND: Novel therapies often fail to reach the bedside due to low trial recruitment rates. Prior to conducting one of the first chimeric antigen receptor (CAR) T cell therapy trials in Canada, we used the Theoretical Domains Framework, a novel tool for identifying barriers and enablers to behavior change, to identify physician-related barriers and enablers to screening and recruiting patients for an early phase immunotherapy trial. METHODS: We conducted interviews with hematologists across Canada and used a directed content analysis to identify relevant domains reflecting the key factors that may affect screening and recruitment. RESULTS: In total, we interviewed 15 hematologists. Physicians expressed "cautious hope"; while expressing safety, feasibility, and screening criteria concerns, 14 out of 15 hematologists intended to screen for the trial (domains: knowledge, goals, beliefs about consequences, intentions). Physicians underscored the "challenging contexts," identifying resources, workload, forgetting, and patient wait times to receive CAR T cells as key practical barriers to screening (domains: environmental context and resources, memory, attention and decision-making, behavioral regulation). They also highlighted "variability in roles and procedures" that may lead to missed trial candidates (domain: social and professional role). Left unaddressed, these barriers may undermine trial recruitment. CONCLUSIONS: This study is among the first to use the Theoretical Domains Framework from the physician perspective to identify recruitment challenges to early phase trials and demonstrates the value of this approach for identifying barriers to screening and recruitment that may not otherwise have been elicited. This approach can optimize trial procedures and may serve to inform future promising early phase cancer therapy trials. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03765177 . Registered on December 5, 2018.


Assuntos
Médicos , Receptores de Antígenos Quiméricos , Canadá , Terapia Baseada em Transplante de Células e Tecidos , Humanos , Papel Profissional
16.
Stem Cells Transl Med ; 10(7): 968-975, 2021 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-33570257

RESUMO

Cell-based therapies hold promise to substantially curb complications from extreme preterm birth, the main cause of death in children below the age of 5 years. Exciting preclinical studies in experimental neonatal lung injury have provided the impetus for the initiation of early phase clinical trials in extreme preterm infants at risk of developing bronchopulmonary dysplasia. Clinical translation of promising therapies, however, is slow and often fails. In the adult population, results of clinical trials so far have not matched the enticing preclinical data. The neonatal field has experienced many hard-earned lessons with the implementation of oxygen therapy or postnatal steroids. Here we briefly summarize the preclinical data that have permitted the initiation of early phase clinical trials of cell-based therapies in extreme preterm infants and describe the INCuBAToR concept (Innovative Neonatal Cellular Therapy for Bronchopulmonary Dysplasia: Accelerating Translation of Research), an evidence-based approach to mitigate the risk of translating advanced therapies into this vulnerable patient population. The INCuBAToR addresses several of the shortcomings at the preclinical and the clinical stage that usually contribute to the failure of clinical translation through (a) systematic reviews of preclinical and clinical studies, (b) integrated knowledge transfer through engaging important stakeholders early on, (c) early economic evaluation to determine if a novel therapy is viable, and (d) retrospective and prospective studies to define and test ideal eligibility criteria to optimize clinical trial design. The INCuBAToR concept can be applied to any novel therapy in order to enhance the likelihood of success of clinical translation in a timely, transparent, rigorous, and evidence-based fashion.

17.
Health Psychol Rev ; : 1-28, 2021 Jan 25.
Artigo em Inglês | MEDLINE | ID: mdl-33446062

RESUMO

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.

19.
Diabet Med ; 38(4): e14429, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33068305

RESUMO

AIM: To identify barriers to/enablers of attendance at eye screening among three groups of immigrantsto Canada from cultural/linguistic minority groups living with diabetes. METHODS: Using a patient-oriented research approach leveraging Diabetes Action Canada's patient engagement platform, we interviewed a purposeful sample of people with type 2 diabetes who had immigrated to Canada from: Pakistan (interviews in Urdu), China (interviews in Mandarin) and French-speaking African and Caribbean nations (interviews in French). We collected and analysed data based on the Theoretical Domains Framework covering key modifiable factors that may operate as barriers to or enablers of attending eye screening. We used directed content analysis to code barrier/enabler domains. Barriers/enablers were mapped to behaviour change techniques to inform future intervention development. RESULTS: We interviewed 39 people (13 per group). Many barriers/enablers were consistent across groups, including views about harms caused by screening itself, practical appointment issues including forgetting, screening costs, wait times and making/getting to an appointment, lack of awareness about retinopathy screening, language barriers, and family and clinical support. Group-specific barriers/enablers included a preference to return to one's country of birth for screening, the impact of winter, and preferences for alternative medicine. CONCLUSION: Our results can inform linguistic and culturally competent interventions to support immigrants living with diabetes in attending eye screening to prevent avoidable blindness.

20.
J Clin Epidemiol ; 132: 106-115, 2021 04.
Artigo em Inglês | MEDLINE | ID: mdl-33338563

RESUMO

OBJECTIVES: Despite clear evidence showing that many clinical trials fail or are delayed because of poor patient recruitment, there is surprisingly little empirically supported guidance for trialists seeking to optimize their trial recruitment strategies. We propose that the challenges of recruitment can be better understood and addressed by thinking of research participation as one or more behaviors, subject to the same forces as other human behaviors. In this article, we describe an adaptable, behavioral theory-driven approach for designing pretrial surveys of the barriers and drivers relevant to trial participation. Instead of proposing a single survey instrument intended to be used uniformly across many situations, we propose that tailored surveys be informed by a common comprehensive, theory-guided development approach that ensures all domains potentially guiding participation are considered. STUDY DESIGN AND SETTING: We used the Theoretical Domains Framework (TDF), which organizes over 100 constructs known to be associated with behavior and behavior change into 14 domains that describe determinants of professional and patient health behaviors, to inform the development of tailored surveys about barriers to and drivers of clinical trial participation. After searching the literature for barriers and drivers to trial recruitment relevant to each of the TDF domains, we developed separate surveys for members of two national health charities (Canadian Breast Cancer Network, Huntington Society of Canada) to exemplify how the approach can be adapted across settings. We conducted think-aloud interviews with members of each group to maximize the clarity and usability of the surveys, elicited opinions about which barriers/drivers were relevant for each patient group, and identified additional barriers/drivers. Interviews proceeded iteratively with changes incorporated into subsequent interviews. Here, we describe our two target patient groups, as well as our process of modifying, adding, and deleting barrier/driver items for each group and across theoretical domains. RESULTS: We interviewed 8 women with a history of breast cancer from the Canadian Breast Cancer Network (48-65 year old) and 11 Huntington Disease community members (9 women) from the Huntington Society of Canada (26-70 year old). After the iterative development interviews, the breast cancer group had identified 38 barriers/drivers thought relevant to their participation in clinical trials across 12 TDF domains. The Huntington group identified 47 items across 13 TDF domains. CONCLUSION: Our patient-focused and theory-guided approach was able to identify a more comprehensive range of barriers to and drivers of trial participation than existing published tools. Our approach is also more broadly adaptable than such tools, in that it uses a theoretical framework and in-depth piloting to generate a set of items tailored to each specific clinical area, rather than a single set of items intended to be applicable to all situations. This theory-guided approach also enables more specific recruitment strategies to be developed once domain-specific barriers are known, potentially optimizing participation for a given trial and helping build a cumulative evidence of barriers/drivers and strategies for addressing them.


Assuntos
Neoplasias da Mama/epidemiologia , Seleção de Pacientes , Projetos de Pesquisa , Adulto , Idoso , Canadá/epidemiologia , Feminino , Humanos , Pessoa de Meia-Idade , Adulto Jovem
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