Mixed Methods Clinical Research with Couples and Families

2013 ◽  
pp. 288-303
Keyword(s):  
Mixed Methods ◽  
Clinical Research

Abstract W P306: Identifying Stroke Researcher Challenges to Minority Inclusion in Clinical Research

Stroke ◽  
2014 ◽  
Vol 45 (suppl_1) ◽  
Author(s):  
Heather Carman ◽  
Leigh Quarles ◽  
Lauren Southwick ◽  
Emma K Benn ◽  
Salina P Waddy ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Mixed Methods ◽  
Best Practices ◽  
Clinical Research ◽  
Focus Groups ◽  
Minority Recruitment ◽  
Mixed Methods Approach ◽  
Recruitment And Retention ◽  
Patient Reported ◽  
Key Informant

Background: Race-ethnic disparities exist in stroke incidence, recurrence and mortality. Minority participation in stroke clinical trials is staggeringly low. A significant literature describes patient-reported barriers to recruitment, but researcher barriers are not well documented. Aim: To assess stroke researcher best practices and challenges to minority inclusion in stroke trials. Methods: The National Initiative for Minority Involvement in Neurological Clinical Trials (NIMICT) uses a mixed methods approach including surveys, focus groups and key informant interviews to expand on understanding of minority recruitment and retention in stroke clinical trials. We designed and tested a 40-item survey based on literature review and used the results to inform semi-structured focus groups and key informant interviews among stroke clinical trial investigators (N=110). Results: Key stroke investigators, identified through the Princeton Conference, were invited via email to participate in the survey. Over 70% (n=93) responded: 68% White. Less than half (N=43) reported actively setting recruitment goals for minority inclusion. Only 37% (N=29) required cultural sensitivity training for recruitment staff. Over 80% reported treating adults unable to consent and were concerned about acute stroke time constraints negatively impacting patient/family participation decisions. Key themes from focus groups (N=17) included: 1) Role of government in defining valid minority sub analyses and enforcing existing inclusion guidelines; 2) Challenges unique to acute setting including consent in conditions of prognostic uncertainty; 3) Lack of scientific/research literacy in the lay population; 4) Lack of community engagement including Primary Care Physicians; 5) Lack of cost data to adequately budget for inclusion efforts. Best practices included health literate consent forms, cultural competency, and motivational interview training for coordinators. Conclusion: NIMICT’s mixed methods approach contributes new perspectives on unique challenges in stroke clinical research. These findings will inform strategies to improve minority recruitment and retention among neurological clinical trials.

scholarly journals Potential challenges in conducting clinical trials with mixed methods approach

2019 ◽  
pp. 17
Author(s):  
Muhamed Ibnas ◽  
M. Asim ◽  
B. Sathian
Keyword(s):  
Clinical Trial ◽  
Qualitative Research ◽  
Clinical Trials ◽  
Mixed Methods ◽  
Clinical Research ◽  
Mixed Method ◽  
Mixed Method Research ◽  
Mixed Method Approach ◽  
Mixed Methods Approach ◽  
Method Approach

Background: Clinical trial is being conducted to assess the safety, efficacy and/or dosage regimen of a drug or therapeutic intervention in human subjects which are carefully selected on predetermined criteria. On the other hand, qualitative research is open-ended focuses on the depth of understanding of issues that are beyond the scope of quantitative analysis. Although, quantitative method is predominated in clinical research; over the past decade qualitative approach is being recognized for its value and unique contributions and is increasingly incorporated in clinical research. The combination of these two approaches in a single study is referred as Mixed Method design. Herein, we aim to explore the major challenges and pitfalls in conducting clinical trials with mixed method approach. Materials and methods: We reviewed the published literature in English language through the research engines (PubMed and Google Scholar) involving clinical trials/studies with mixed method approach to look for the potential challenges and issues identified during the conduct of mixed method research (MMR). Results: There are various issues in conducting clinical trials with mixed methods approach as it is time consuming, requires expertise, skills and methodological training for both quantitative and qualitative research. Also, there are a number of challenges observed while conducting MMR, such as obtaining informed consent, safety events reporting, data retrieval, study documentation, data confidentiality and storage, inappropriate integration and interpretation of the data as well as incorrect ordering, preferences and objective of each method. Conclusion: Use of hybrid approach in clinical trial can provide deeper understanding and insights of research question with higher validity and reliability. MMR has certain challenges which can be overcome by in-depth methodological training and collaboration. Therefore, strong collaboration between clinical and social scientists in necessary to design a competitive funding grant for mixed method research. Finally, integration and implementation of MMR is crucial for conducting pragmatic trials.

scholarly journals Mixing Research Methods in Health Professional Degrees: Thoughts for Undergraduate Students and Supervisors

2015 ◽  
Author(s):  
Sophie Anaf ◽  
Lorraine Sheppard
Keyword(s):  
Mixed Methods ◽  
Health Professional ◽  
Clinical Research ◽  
Research Methods ◽  
Undergraduate Students ◽  
Mixed Methods Research ◽  
Undergraduate Research ◽  
Theoretical Level ◽  
Professional Degrees ◽  
Practical Level

This commentary considers some of the challenges of applying mixed methods research in undergraduate research degrees, especially in professions with a clinical health focus. Our experience in physiotherapy academia is used as an example. Mixed methods research is increasingly appreciated in its own right as a “third paradigm,” however the success of educating novice researchers in mixing methods requires reflection on a range of theoretical and practical issues. We explore some of the under- reported features of mixed methods on a theoretical level, including the use of terminology, and the challenge of research “labels,” and on a practical level, the benefits of including mixing methods in clinical research and the issue of appropriate examination.

scholarly journals Feasibility of Social Media–Based Recruitment and Perceived Acceptability of Digital Health Interventions for Caregivers of Justice-Involved Youth: Mixed Methods Study

10.2196/16370 ◽  
2020 ◽  
Vol 22 (4) ◽  
pp. e16370
Author(s):  
Johanna Bailey Folk ◽  
Anna Harrison ◽  
Christopher Rodriguez ◽  
Amanda Wallace ◽  
Marina Tolou-Shams
Keyword(s):  
Social Media ◽  
Mixed Methods ◽  
Clinical Research ◽  
Behavioral Health ◽  
Digital Health ◽  
Behavioral Health Care ◽  
Health Interventions ◽  
Mixed Methods Study ◽  
Phone Interview ◽  
Biological Parents

Background Caregiver involvement is critical for supporting positive behavioral health and legal outcomes for justice-involved youth; however, recruiting this population into clinical research studies and engaging them in treatment remain challenging. Technology-based approaches are a promising, yet understudied avenue for recruiting and intervening with caregivers of justice-involved youth. Objective This mixed methods study aimed to assess the feasibility of recruiting caregivers of justice-involved youth using social media into clinical research and to understand caregivers’ perceptions of the acceptability of digital health interventions. Methods Caregivers of justice-involved youth were recruited through paid Facebook advertisements to participate in a Web-based survey. Advertisement design was determined using Facebook A/B split testing, and the advertisement with the lowest cost per link click was used for the primary advertisement campaign. Survey participants were offered the option to participate in a follow-up qualitative phone interview focused on the perceived feasibility and acceptability of digital health interventions. Results Facebook advertisements were successful in quickly recruiting a diverse set of caregivers (80/153, 52.3% female; mean age 43 years, SD 7; 76/168, 45.2% black, 34/168, 20.2% white, and 28/168, 16.7% Latinx; and 97/156, 62.2% biological parents); cost per click was US $0.53, and conversion rate was 11.5%. Survey participants used multiple social media platforms; 60.1% (101/168) of the participants indicated they would participate in a digital health intervention for caregivers of justice-involved youth. Survey respondents’ most preferred intervention was supportive and motivational parenting messages via SMS text message. Of the survey respondents, 18 completed a phone interview (12/18, 67% female; mean age 45 years, SD 10; 10/18, 56% black, 7/18, 39% white, and 1/18, 6% Latinx; and 16/18, 89% biological parents). Interview participant responses suggested digital health interventions are acceptable, but they expressed both likes (eg, alleviates barriers to treatment access) and concerns (eg, privacy); their most preferred intervention was video-based family therapy. Conclusions Recruiting and intervening with caregivers of justice-involved youth through social media and other digital health approaches may be a feasible and acceptable approach to overcoming barriers to accessing traditional in-person behavioral health care.

scholarly journals Improving interdisciplinary research through educational trading zones: A mixed methods approach to evaluating communication patterns between physicians and statisticians

2016 ◽  
Vol 10 (25) ◽  
pp. 1164
Author(s):  
João Ricardo Nickenig Vissoci ◽  
Luciano Andrade ◽  
Adelia Portero Batilana ◽  
Elias Andrade Carvalho ◽  
Aline Chotte Oliveira ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Qualitative Study ◽  
Clinical Research ◽  
Interdisciplinary Research ◽  
Conceptual Models ◽  
Mixed Methods Approach ◽  
Trading Zones ◽  
Communication Difficulties ◽  
Research Questions ◽  
Emerging Themes

Objective: The objective of this study was to perform a qualitative study to identify commonalities and differences in reasoning processes between these groups.Methods: A phenomenological qualitative study based on transcriptions of physicians and statisticians conceptualizing clinical cases and clinical research questions. Interviews were carried out with nine statisticians and sixteen physicians contacted virtually. The main outcome measures were emerging themes that were common to both expert groups.Results: Both groups used conceptual models -although different models- during their reasoning processes, but their concepts were not common between the groups complicating the exchange of information. Both groups were unaware that their specialty language was frequently inaccessible to non-specialists or specialists from other fields, which leads to communication difficulties. These difficulties were broadly classified into translational problems of field-specific terms and concepts. Field-specific terms would sometimes lead to misinterpretations while the translation of field-specific concepts often leads to content loss.Conclusions: The use of field-specific terms and concepts can lead to confusion and misinterpretation. Teams would benefit from taxonomies containing terms that can be understood by specialists from both disciplines

Capacity of Community Advisory Boards for Effective Engagement in Clinical Research; a Mixed Methods Study

2021 ◽  
Author(s):  
Levicatus Mugenyi ◽  
Andrew Mijumbi ◽  
Mastula Nanfuka ◽  
Collins Agaba ◽  
Fedress Kaliba ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Clinical Research ◽  
Community Engagement ◽  
Research Ethics ◽  
Health Research ◽  
Tertiary Education ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Advisory Boards ◽  
Community Advisory Boards

Abstract Background: Community engagement is a key component in health research. One of the ways health researchers ensure community engagement is through Community Advisory Boards (CABs). The capacity of CABs to properly perform their role in clinical research has not been well described in many resource limited settings. In this study, we assessed the capacity of CABs for effective community engagement in Uganda.Methods: We conducted a cross sectional study with mixed methods. We used structured questionnaires and key informant interviews (KII) to collect data from CAB members, trial investigators, and community liaison officers. For quantitative data, we used descriptive statistics while for qualitative data we used content analysis. Results: Seventy three CAB members were interviewed using structured questionnaires; 58.9% males, median age 49 years (IQR: 24-70), 71.2% had attained tertiary education, 42.5% never attended any research ethics training, only 26% had a training in human subject protection, 30.1% had training in health research, 50.7% never attended any training about the role of CABs, and 72.6% had no guidelines for their operation. On the qualitative aspect, 24 KIIs cited CAB members to have some skills and ability to understand and review study documents, offer guidance on community norms and expectations and give valuable feedback to the investigators. However, challenges like limited resources, lack of independence and guidelines, and knowledge gaps about research ethics were cited as hindrances of CABs capacity.Conclusion: Though CABs have some capacity to perform their role in the Ugandan setting, their functionality is limited by lack of resources to facilitate their work, independence, guidelines for their operations and limited knowledge.

scholarly journals Capacity of community advisory boards for effective engagement in clinical research: a mixed methods study

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Levicatus Mugenyi ◽  
Andrew Mijumbi ◽  
Mastula Nanfuka ◽  
Collins Agaba ◽  
Fedress Kaliba ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Clinical Research ◽  
Community Engagement ◽  
Research Ethics ◽  
Health Research ◽  
Tertiary Education ◽  
Cross Sectional Study ◽  
Cross Sectional ◽  
Advisory Boards ◽  
Community Advisory Boards

Abstract Background Community engagement is a key component in health research. One of the ways health researchers ensure community engagement is through Community Advisory Boards (CABs). The capacity of CABs to properly perform their role in clinical research has not been well described in many resource limited settings. In this study, we assessed the capacity of CABs for effective community engagement in Uganda. Methods We conducted a cross sectional study with mixed methods. We used structured questionnaires and key informant interviews (KII) to collect data from CAB members, trial investigators, and community liaison officers. For quantitative data, we used descriptive statistics while for qualitative data we used content analysis. Results Seventy three CAB members were interviewed using structured questionnaires; 58.9% males, median age 49 years (IQR 24–70), 71.2% had attained tertiary education, 42.5% never attended any research ethics training, only 26% had a training in human subject protection, 30.1% had training in health research, 50.7% never attended any training about the role of CABs, and 72.6% had no guidelines for their operation. On the qualitative aspect, 24 KIIs cited CAB members to have some skills and ability to understand and review study documents, offer guidance on community norms and expectations and give valuable feedback to the investigators. However, challenges like limited resources, lack of independence and guidelines, and knowledge gaps about research ethics were cited as hindrances of CABs capacity. Conclusion Though CABs have some capacity to perform their role in the Ugandan setting, their functionality is limited by lack of resources to facilitate their work, lack of independence, lack of guidelines for their operations and limited knowledge regarding issues of research ethics and protection of the rights of trial participants.

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