Potential challenges in conducting clinical trials with mixed methods 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.

Download Full-text

Leadership in a time of financial crisis: what do we want from our leaders?

Leadership & Organization Development Journal ◽

10.1108/lodj-12-2013-0166 ◽

2015 ◽

Vol 36 (5) ◽

pp. 612-627 ◽

Cited By ~ 11

Author(s):

Arlene Haddon ◽

Catherine Loughlin ◽

Corinne McNally

Keyword(s):

Mixed Methods ◽

Mixed Method ◽

Sex Role ◽

Qualitative Interviews ◽

Crisis Leadership ◽

Organizational Crisis ◽

Content Type ◽

Mixed Methods Approach ◽

Nuanced Understanding ◽

Method Approach

Purpose – The purpose of this paper is to gain a nuanced understanding of what employees want from leaders in an organizational crisis context. Design/methodology/approach – The authors use a mixed methods approach to explore employee leadership preferences during organizational crisis and non-crisis times using the Multi Factor Leadership Questionnaire (Avolio and Bass, 2004), and qualitative interviews. The authors also investigate sex roles using the Bem Sex Role Inventory (Bem, 1981). Findings – The mixed method approach reveals some potential limitations in how leadership is typically measured. The qualitative findings highlight employees’ expectations of leaders to take action quickly while simultaneously engaging in continuous communication with employees during crisis. None of the components of transformational leadership encapsulate this notion. Originality/value – The mixed methods approach is novel in the crisis leadership literature. Had the authors relied solely on the quantitative measures, the importance of continuous communication during crisis would not have been apparent. As a result of this approach, the findings suggest that widely used and accepted measures of leadership may not adequately capture leadership in a crisis context. This is timely as it aligns with current literature which questions the way this construct is operationalized (Van Knippenberg and Sitkin, 2013).

Download Full-text

Designing a PhD Proposal in Mixed Method Research

Advances in Library and Information Science - Social Research Methodology and New Techniques in Analysis, Interpretation, and Writing ◽

10.4018/978-1-5225-7897-0.ch003 ◽

2019 ◽

pp. 36-48

Author(s):

Ndungi wa Mungai

Keyword(s):

Mixed Method ◽

Quantitative Methods ◽

Research Proposal ◽

Mixed Method Research ◽

Hypothetical Case ◽

Mixed Method Approach ◽

Qualitative And Quantitative ◽

Qualitative And Quantitative Methods ◽

Definition Of ◽

Method Approach

This chapter reviews the challenges and advantages of writing a mixed method research (MMR) proposal. The argument put forward is that a mixed method approach overcomes the shortcomings of the commonly used qualitative and quantitative methods. A brief definition of a research proposal is followed by a discussion on the different interpretations of a mixed method and what makes mixed methods ideal in the proposal example that follows. A mixed method can be either one that utilizes qualitative and quantitative methods to different degrees or it can be regarded as a distinct method by itself. A mixed method is suitable where both different types of data can be collected, when the data adds value to what would be achieved using one approach and where cost also justifies it. A hypothetical case example where an application is being made to conduct an evaluation of an anti-truancy program is presented.

Download Full-text

Elaboration, Generalization, Triangulation, and Interpretation

Organizational Research Methods ◽

10.1177/1094428116639133 ◽

2016 ◽

Vol 20 (2) ◽

pp. 193-223 ◽

Cited By ~ 45

Author(s):

Cristina B. Gibson

Keyword(s):

Mixed Methods ◽

Mixed Method ◽

Comprehensive Analysis ◽

Mixed Method Research ◽

The Past ◽

Case Comparison ◽

Novel Approaches ◽

Organizational Science ◽

Method Approach ◽

Selection Of

This article examines means of enhancing the value of mixed method research for organizational science. Conclusions are based on a comprehensive analysis of 69 mixed method articles published in four empirical journals between 2009 and 2014, detailed case comparison of four illustrative articles, and personal interviews with lead authors for each case. Findings provide three key contributions. First, documenting the prevalence of mixed methods over the past six years in a broad selection of journals, five approaches to mixed method research are identified—including three novel approaches not yet elaborated on in prior treatises on research methods, expanding the feasible options for mixed method scholarship and bolstering confidence in considering such approaches. Second, themes pertaining to enhancing the value of mixed method research are revealed, including elaboration, generalization, triangulation, and interpretation. Finally, findings uncovered four sets of practical techniques by which this value can be increased. Together, these contributions provide guidance for those endeavoring to utilize a mixed method approach in organizational science.

Download Full-text

QUANTITATIVE AND QUALITATIVE RESEARCH: A MIXED METHOD APPROACH IN EDUCATIONAL SCIENCE

International Journal of Technical Research & Science ◽

10.30780/ijtrs.v3.i7.2018.010 ◽

2018 ◽

Vol 3 (VII) ◽

Author(s):

Prokash Mondal ◽

Susmita Mondal

Keyword(s):

Qualitative Research ◽

Mixed Method ◽

Educational Science ◽

Mixed Method Approach ◽

Quantitative And Qualitative Research ◽

Method Approach

Download Full-text

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

Stroke ◽

10.1161/str.45.suppl_1.wp306 ◽

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.

Download Full-text

The Complexity of Human Social Interactions Calls for Mixed Methods in HRI

ACM Transactions on Human-Robot Interaction ◽

10.1145/3439715 ◽

2021 ◽

Vol 10 (1) ◽

pp. 1-4

Author(s):

Johanna Seibt ◽

Christina Vestergaard ◽

Malene F. Damholdt

Keyword(s):

Mixed Methods ◽

Social Interactions ◽

Mixed Method ◽

Quantitative Methods ◽

Social Reality ◽

Human Robot Interaction ◽

Research Note ◽

Robot Interaction ◽

Mixed Method Approach ◽

Method Approach

In this research note, we offer a comment on the “A Primer for Conducting Experiments in Human-robot Interaction,” by G. Hoffman and X. Zhao, suggesting that due to the complexity of human social reality quantitative methods should be integrated into a mixed method approach.

Download Full-text

A Framework for Mixed-method Research

Shanlax International Journal of Management ◽

10.34293/management.v8i2.3220 ◽

2020 ◽

Vol 8 (2) ◽

pp. 45-53

Author(s):

Sindhu Shantha Nair ◽

Smritika S Prem

Keyword(s):

Mixed Method ◽

Quantitative Research ◽

Empirical Studies ◽

Future Research ◽

Mixed Method Research ◽

Mixed Method Approach ◽

Quantitative And Qualitative Research ◽

Main Components ◽

Method Approach

This article presents the basics of mixed-method research as a distinct methodology that uses both quantitative and qualitative research methods to create empirical research. The method of this study is a review. Through a substantive review, this paper explains the basic idea of a mixed method approach. The article identifies the main components of the mixed-method approach, provides examples, and describes how to conduct mixed-method research. A quantitative study involves collecting, identifying, and analyzing data. A qualitative study uses interviews or focus groups. An integration of both approaches helps a better understanding of the issue. This study brings out the role of mixed-method research to assess further approaches in future research practices. The combination of qualitative and quantitative research will enable a broader reach in empirical studies.

Download Full-text