scholarly journals Wise Practices for Cultural Safety in Electronic Health Research and Clinical Trials With Indigenous People: Secondary Analysis of a Randomized Clinical Trial

10.2196/14203 ◽  
2019 ◽  
Vol 21 (11) ◽  
pp. e14203 ◽  
Author(s):  
Marion A Maar ◽  
Valerie Beaudin ◽  
Karen Yeates ◽  
Lisa Boesch ◽  
Peter Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Indigenous Peoples ◽  
Indigenous Communities ◽  
Lessons Learned ◽  
Cultural Safety ◽  
Controlled Clinical Trial ◽  
Data Set ◽  
Evaluation Data ◽  
Electronic Health ◽  
Wise Practices

Background There is a paucity of controlled clinical trial data based on research with Indigenous peoples. A lack of data specific to Indigenous peoples means that new therapeutic methods, such as those involving electronic health (eHealth), will be extrapolated to these groups based on research with other populations. Rigorous, ethical research can be undertaken in collaboration with Indigenous communities but requires careful attention to culturally safe research practices. Literature on how to involve Indigenous peoples in the development and evaluation of eHealth or mobile health apps that responds to the needs of Indigenous patients, providers, and communities is still scarce; however, the need for community-based participatory research to develop culturally safe technologies is emerging as an essential focus in Indigenous eHealth research. To be effective, researchers must first gain an in-depth understanding of Indigenous determinants of health, including the harmful consequences of colonialism. Second, researchers need to learn how colonialism affects the research process. The challenge then for eHealth researchers is to braid Indigenous ethical values with the requirements of good research methodologies into a culturally safe research protocol. Objective A recent systematic review showed that Indigenous peoples are underrepresented in randomized controlled trials (RCTs), primarily due to a lack of attention to providing space for Indigenous perspectives within the study frameworks of RCTs. Given the lack of guidelines for conducting RCTs with Indigenous communities, we conducted an analysis of our large evaluation data set collected in the Diagnosing Hypertension-Engaging Action and Management in Getting Lower Blood Pressure in Indigenous Peoples and Low- and Middle- Income Countries (DREAM-GLOBAL) trial over a period of five years. Our goal is to identify wise practices for culturally safe, collaborative eHealth and RCT research with Indigenous communities. Methods We thematically analyzed survey responses and qualitative interview/focus group data that we collected over five years in six culturally diverse Indigenous communities in Canada during the evaluation of the clinical trial DREAM-GLOBAL. We established themes that reflect culturally safe approaches to research and then developed wise practices for culturally safe research in pragmatic eHealth research. Results Based on our analysis, successful eHealth research in collaboration with Indigenous communities requires a focus on cultural safety that includes: (1) building a respectful relationship; (2) maintaining a respectful relationship; (3) good communication and support for the local team during the RCT; (4) commitment to co-designing the innovation; (5) supporting task shifting with the local team; and (6) reflecting on our mistakes and lessons learned or areas for improvement that support learning and cultural safety. Conclusions Based on evaluation data collected in the DREAM-GLOBAL RCT, we found that there are important cultural safety considerations in Indigenous eHealth research. Building on the perspectives of Indigenous staff and patients, we gleaned wise practices for RCTs in Indigenous communities. Trial Registration ClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226

scholarly journals Wise Practices for Cultural Safety in Electronic Health Research and Clinical Trials With Indigenous People: Secondary Analysis of a Randomized Clinical Trial (Preprint)

2019 ◽  
Author(s):  
Marion A Maar ◽  
Valerie Beaudin ◽  
Karen Yeates ◽  
Lisa Boesch ◽  
Peter Liu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Indigenous Peoples ◽  
Indigenous Communities ◽  
Lessons Learned ◽  
Cultural Safety ◽  
Controlled Clinical Trial ◽  
Data Set ◽  
Evaluation Data ◽  
Electronic Health ◽  
Wise Practices

BACKGROUND There is a paucity of controlled clinical trial data based on research with Indigenous peoples. A lack of data specific to Indigenous peoples means that new therapeutic methods, such as those involving electronic health (eHealth), will be extrapolated to these groups based on research with other populations. Rigorous, ethical research can be undertaken in collaboration with Indigenous communities but requires careful attention to culturally safe research practices. Literature on how to involve Indigenous peoples in the development and evaluation of eHealth or mobile health apps that responds to the needs of Indigenous patients, providers, and communities is still scarce; however, the need for community-based participatory research to develop culturally safe technologies is emerging as an essential focus in Indigenous eHealth research. To be effective, researchers must first gain an in-depth understanding of Indigenous determinants of health, including the harmful consequences of colonialism. Second, researchers need to learn how colonialism affects the research process. The challenge then for eHealth researchers is to braid Indigenous ethical values with the requirements of good research methodologies into a culturally safe research protocol. OBJECTIVE A recent systematic review showed that Indigenous peoples are underrepresented in randomized controlled trials (RCTs), primarily due to a lack of attention to providing space for Indigenous perspectives within the study frameworks of RCTs. Given the lack of guidelines for conducting RCTs with Indigenous communities, we conducted an analysis of our large evaluation data set collected in the Diagnosing Hypertension-Engaging Action and Management in Getting Lower Blood Pressure in Indigenous Peoples and Low- and Middle- Income Countries (DREAM-GLOBAL) trial over a period of five years. Our goal is to identify wise practices for culturally safe, collaborative eHealth and RCT research with Indigenous communities. METHODS We thematically analyzed survey responses and qualitative interview/focus group data that we collected over five years in six culturally diverse Indigenous communities in Canada during the evaluation of the clinical trial DREAM-GLOBAL. We established themes that reflect culturally safe approaches to research and then developed wise practices for culturally safe research in pragmatic eHealth research. RESULTS Based on our analysis, successful eHealth research in collaboration with Indigenous communities requires a focus on cultural safety that includes: (1) building a respectful relationship; (2) maintaining a respectful relationship; (3) good communication and support for the local team during the RCT; (4) commitment to co-designing the innovation; (5) supporting task shifting with the local team; and (6) reflecting on our mistakes and lessons learned or areas for improvement that support learning and cultural safety. CONCLUSIONS Based on evaluation data collected in the DREAM-GLOBAL RCT, we found that there are important cultural safety considerations in Indigenous eHealth research. Building on the perspectives of Indigenous staff and patients, we gleaned wise practices for RCTs in Indigenous communities. CLINICALTRIAL ClinicalTrials.gov NCT02111226; https://clinicaltrials.gov/ct2/show/NCT02111226

Barriers and Enablers to Older Indigenous People Engaging in Physical Activity—A Qualitative Systematic Review

2021 ◽  
pp. 1-13
Author(s):  
Margaret J.R. Gidgup ◽  
Marion Kickett ◽  
Tammy Weselman ◽  
Keith Hill ◽  
Julieann Coombes ◽  
...  
Keyword(s):  
Physical Activity ◽  
Systematic Review ◽  
Indigenous Peoples ◽  
Indigenous Communities ◽  
Cultural Safety ◽  
Barriers And Enablers ◽  
Qualitative Systematic Review ◽  
Physical Activity Programs ◽  
Key Barrier ◽  
Appraisal Tool

The objective of this qualitative systematic review was to synthesize all evidence to understand the barriers and enablers to older Indigenous peoples (aged 40 years and older) engaging in physical activity. Four databases were searched. Study quality was assessed from an Indigenous perspective, using an Aboriginal and Torres Strait Islander quality appraisal tool. Data were analyzed using thematic synthesis. There were 4,246 articles screened with 23 articles and one report included from over 30 Indigenous communities across four countries. Cultural Safety and Security was a key enabler, including developing physical activity programs which are led by Indigenous communities and preference Indigenous values. Colonization was a key barrier that created mistrust and uncertainty. Social Determinants of Health, including cost, were supported by successful programs, but if not addressed, were demotivators of engagement. Older Indigenous peoples identified barriers and enablers that can direct the development of sustainable, culturally appropriate physical activity programs.

scholarly journals Otsin: Sharing the spirit--Development of an indigenous rural nursing practice course

2018 ◽  
Vol 8 (12) ◽  
pp. 29 ◽  
Author(s):  
Sheila Blackstock
Keyword(s):  
Indigenous Peoples ◽  
Nursing Practice ◽  
Cultural Practices ◽  
Indigenous Communities ◽  
Cultural Safety ◽  
Student Centered ◽  
Teaching Pedagogy ◽  
Rural Nursing ◽  
Undergraduate Nursing ◽  
Northern Community

Otsin is the spirt of Gitxsan Peoples and is reflected by the Gitxsan author sharing the journey in the development of a unique third year undergraduate nursing practice course. The nursing practice course immerses students in a combined rural and an interdisciplinary indigenous nursing practice. The practice course is based on a student centered, context-based teaching pedagogy using a two-eyed seeing approach. The theoretical tenet of place is reconceptualized to reflect Indigenous communities and rural nursing practice. The metaphor of weaving together cedar strips is used to reflect a journey that takes students through the experiences of living and practicing in a rural northern community while embracing on the land experiences, cultural practices, traditions, language and ceremonies. The traditional academy curricula are challenged to broaden the lens beyond the classroom theatre walls to rural, indigenous nursing practice experiences. The weaving of the cedar strips together and allows students to construct their understanding of the impacts of colonization on Indigenous Peoples and an opportunity to be guided by the community to practice cultural safety.

scholarly journals Cedar Project: Conducting Health Research with Indigenous Peoples in a Good Way

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
◽  
Richa Sharma ◽  
Violet Bozoki ◽  
Earl Henderson ◽  
Lou Demerais ◽  
...  
Keyword(s):  
Indigenous Peoples ◽  
Historical Trauma ◽  
Indigenous Communities ◽  
Cultural Safety ◽  
Multiple Perspectives ◽  
Hepatitis C Infection ◽  
Community Based Research ◽  
Indigenous Voice ◽  
Indigenous Perspectives ◽  
Conducting Research

The Cedar Project is an interdisciplinary, community-driven research project responding to the crises of HIV and Hepatitis C infection and contributing to the healing of young Indigenous people who use or have used drugs. We are a collective membership of Indigenous Elders, health/social service experts, researchers, and non-Indigenous allies. We situate our work in the context of strength, resilience, and rights to self-determination for Indigenous peoples while also acknowledging the ongoing impacts of historical, intergenerational, and current trauma, specifically those related to the child welfare systems. We provide epidemiological and qualitative evidence that reflects Indigenous perspectives of health and wellness. In this paper, we highlight over seventeen years of shared learnings on conducting research with Indigenous communities in a good way. Specifically, we elaborate on four key components of our unique project. First, our paradigm is to build on young Indigenous people's strengths while acknowledging grief and historical trauma. We recognize that Cedar participants are not statistics—they are relatives of Indigenous partners governing this study. Second, our processes are determined by Indigenous governance, led by Elders and rooted in cultural safety. Third, our research ethics are determined by terms of reference created by the Cedar Project Partnership and by embracing guidelines of TCPS and community-based research. Fourth, we are informed by multiple perspectives and research relationships between Elders, partners, students, academics, and research staff. Sharing our learnings with the larger research community can contribute to decolonizing research spaces by centering Indigenous knowledges and privileging Indigenous voice.

Planting the Seeds: Insights for Researchers Interested in Working With Indigenous Peoples

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Christopher David Macklin ◽  
Chris Marchand ◽  
Eric Mitchell ◽  
Roberta Price ◽  
Vanessa Mitchell ◽  
...  
Keyword(s):  
Indigenous Peoples ◽  
Health Research ◽  
Culturally Responsive ◽  
Ways Of Knowing ◽  
Lessons Learned ◽  
Cultural Safety ◽  
Self Awareness ◽  
Self Reflection ◽  
History Of ◽  
The Mind

Health research in Canada carries a history of exploitation and cultural insensitivity in its approaches, resulting in a deeply rooted mistrust among Indigenous Peoples. Communities are signalling the urgent need for health research to be conducted in a more conscientious way. To address these gaps, our team of three Elders and three researchers co-developed a series of workshops in the province of British Columbia, Canada, in 2019 to increase participants’ knowledge and skills for conducting culturally responsive health research. Workshops examined power and privilege; self-awareness/self-reflection; Indigenous and Western worldviews; cultural safety; allyship; and research principles and practices. Activities were experiential and privileged Indigenous knowledges. An Indigenous-informed evaluation captured participants’ experiences via online surveys. Participants described workshop learnings as deeply impacting ways they approach research practice. Thematic analysis of participant reflections revealed three overarching themes: bringing together the mind and the heart; self-reflection and initiating change; and understanding cultural safety as a lifelong journey. Lessons learned by facilitators included the importance of applying Indigenous ways of knowing to create safe spaces for healing and learning; empowering participants to critically self-reflect; and rooting the work in ceremony. The ethical responsibility to allow time and space for meaningful dialogue was crucial for aligning with Indigenous protocols of coming together. This project demonstrates that experiential workshops, co- facilitated by Elders and researchers, are an innovative, effective, and Indigenous-centred approach for providing education on how to engage in culturally safe and culturally resonant research.

scholarly journals Automated Electronic Health Record–Based Tool for Identification of Patients With Metastatic Disease to Facilitate Clinical Trial Patient Ascertainment

2021 ◽  
pp. 719-727
Author(s):  
Jeffrey Kirshner ◽  
Kelly Cohn ◽  
Steven Dunder ◽  
Karri Donahue ◽  
Madeline Richey ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Electronic Health Record ◽  
Real World ◽  
Predictive Value ◽  
Trial Participation ◽  
Health Record ◽  
Clinical Trial Participation ◽  
Data Set ◽  
Electronic Health ◽  
User Review

PURPOSE To facilitate identification of clinical trial participation candidates, we developed a machine learning tool that automates the determination of a patient's metastatic status, on the basis of unstructured electronic health record (EHR) data. METHODS This tool scans EHR documents, extracting text snippet features surrounding key words (such as metastatic, progression, and local). A regularized logistic regression model was trained and used to classify patients across five metastatic categories: highly likely and likely positive, highly likely and likely negative, and unknown. Using a real-world oncology database of patients with solid tumors with manually abstracted information as reference, we calculated sensitivity, specificity, negative predictive value (NPV), and positive predictive value (PPV). We validated the performance in a real-world data set, evaluating accuracy gains upon additional user review of tool's outputs after integration into clinic workflows. RESULTS In the training data set (N = 66,532), the model sensitivity and specificity (% [95% CI]) were 82.4 [81.9 to 83.0] and 95.5 [95.3 to 96.7], respectively; the PPV was 89.3 [88.8 to 90.0], and the NPV was 94.0 [93.8 to 94.2]. In the validation sample (n = 200 from five distinct care sites), after user review of model outputs, values increased to 97.1 [85.1 to 99.9] for sensitivity, 98.2 [94.8 to 99.6] for specificity, 91.9 [78.1 to 98.3] for PPV, and 99.4 [96.6 to 100.0] for NPV. The model assigned 163 of 200 patients to the highly likely categories. The error prevalence was 4% before and 2% after user review. CONCLUSION This tool infers metastatic status from unstructured EHR data with high accuracy and high confidence in more than 75% of cases, without requiring additional manual review. By enabling efficient characterization of metastatic status, this tool could mitigate a key barrier for patient ascertainment and clinical trial participation in community clinics.

Examination of Individual Differences in Outcomes From a Randomized Controlled Clinical Trial Comparing Formal and Informal Individual Auditory Training Programs

2016 ◽  
Vol 59 (4) ◽  
pp. 876-886 ◽  
Author(s):  
Sherri L. Smith ◽  
Gabrielle H. Saunders ◽  
Theresa H. Chisolm ◽  
Melissa Frederick ◽  
Beth A. Bailey
Keyword(s):  
Clinical Trial ◽  
Word Recognition ◽  
Training Programs ◽  
Hearing Aid ◽  
Auditory Training ◽  
Controlled Clinical Trial ◽  
Randomized Controlled Clinical Trial ◽  
Data Set ◽  
Clinical Variables ◽  
Randomized Controlled

PurposeThe purpose of this study was to determine if patient characteristics or clinical variables could predict who benefits from individual auditory training.MethodA retrospective series of analyses were performed using a data set from a large, multisite, randomized controlled clinical trial that compared the treatment effects of at-home auditory training programs in bilateral hearing aid users. The treatment arms were (a) use of the 20-day computerized Listening and Communication Enhancement program, (b) use of the 10-day digital versatile disc Listening and Communication Enhancement program, (c) use of a placebo “books-on-tape” training, and (d) educational counseling (active control). Multiple linear regression models using data from 263 participants were conducted to determine if patient and clinical variables predicted short-term improvement on word-recognition-in-noise abilities, self-reported hearing handicap, and self-reported hearing problems.ResultsBaseline performance significantly predicted performance on each variable, explaining 11%–17% of the variance in improvement. The treatment arm failed to emerge as a significant predictor with other clinical variables explaining less than 9% of the variance.ConclusionThese results suggest that hearing aid users who have poorer aided word-recognition-in-noise scores and greater residual activity limitations and participation restrictions will show the largest improvement in these areas.

Multicomponential VR-Enhanced Treatment of Emotional Overeating in Obese Subjects: A Controlled Clinical Trial

2006 ◽  
Author(s):  
Gian Mauro Manzoni ◽  
Gian Luca Cesa ◽  
Daniela Villani ◽  
Gianluca Castelnuovo Enrico Molinari ◽  
Giuseppe Riva
Keyword(s):  
Clinical Trial ◽  
Controlled Clinical Trial ◽  
Obese Subjects
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