The primary care provider (PCP)-cancer specialist relationship: A systematic review and mixed-methods meta-synthesis.

Although they are critical to models of coordinated care, the relationship and communication between primary care providers (PCPs) and cancer specialists throughout the cancer continuum are poorly understood. By using predefined search terms, the authors conducted a systematic review of the literature in 3 databases to examine the relationship and communication between PCPs and cancer specialists. Among 301 articles identified, 35 met all inclusion criteria and were reviewed in-depth. Findings from qualitative, quantitative, and disaggregated mixed-methods studies were integrated using meta-synthesis. Six themes were identified and incorporated into a preliminary conceptual model of the PCP-cancer specialist relationship: 1) poor and delayed communication between PCPs and cancer specialists, 2) cancer specialists' endorsement of a specialist-based model of care, 3) PCPs' belief that they play an important role in the cancer continuum, 4) PCPs' willingness to participate in the cancer continuum, 5) cancer specialists' and PCPs' uncertainty regarding the PCP's oncology knowledge/experience, and 6) discrepancies between PCPs and cancer specialists regarding roles. These data indicate a pervasive need for improved communication, delineation, and coordination of responsibilities between PCPs and cancer specialists. Future interventions aimed at these deficiencies may improve patient and physician satisfaction and cancer care coordination. CA Cancer J Clin 2017;67:156-169. © 2016 American Cancer Society.

Primary Care Physician and Urologist Perspectives on Optimizing Active Surveillance for Low-Risk Prostate Cancer.

PURPOSE: We conducted a study to understand primary care physician (PCP) and urologist perspectives on determinants of active surveillance care delivery for men with low-risk prostate cancer. METHODS: We conducted in-depth, semistructured, virtual interviews with a purposive sample of 19 PCPs and 15 urologists between June 2020 and March 2021. We used the behavioral theory-informed Theoretical Domains Framework to understand barriers to and facilitators of active surveillance care delivery. Interviews were recorded, transcribed, and deductively coded into framework domains and constructs by 3 independent coders. Participant recruitment continued until data saturation by group. RESULTS: Our study included 19 PCPs (9 female; 4 in community practices, 15 in academic medical centers) and 15 urologists (3 female; 5 in private practice, 3 in academic medical centers). The most commonly reported Theoretical Domains Framework domains affecting active surveillance care were (1) knowledge and (2) environmental context and resources. Although urologists were knowledgeable about active surveillance, PCPs mentioned limitations in their understanding of active surveillance (eg, what follow-up entails). Both groups noted the importance of an informed patient, especially how a patient's understanding of active surveillance facilitates their receipt of recommended follow-up. Physicians viewed patient loss to follow-up as a barrier, but identified a favorable organizational culture/climate (eg, good communication between physicians) as a facilitator. CONCLUSIONS: With patients increasingly involving their PCPs in their cancer care, our study presents factors both PCPs and urologists perceive (or identify) as affecting optimal active surveillance care delivery. We provide insights that can help inform multilevel supportive interventions for patients, physicians, and organizations to ensure the success of active surveillance as a management strategy for low-risk prostate cancer.

A cross-stakeholder approach to improving out-of-hospital cardiac arrest survival.

BACKGROUND: Out-of-hospital cardiac arrest (OHCA) affects over 300,000 individuals per year in the United States with poor survival rates overall. A remarkable 5-fold difference in survival-to-hospital discharge rates exist across United States communities. METHODS: We conducted a study using qualitative research methods comparing the system of care across sites in Michigan communities with varying OHCA survival outcomes, as measured by return to spontaneous circulation with pulse upon emergency department arrival. RESULTS: Major themes distinguishing higher performing sites were (1) working as a team, (2) devoting resources to coordination across agencies, and (3) developing a continuous quality improvement culture. These themes spanned the chain of survival framework for OHCA. By examining the unique processes, procedures, and characteristics of higher- relative to lower-performing sites, we gleaned lessons learned that appear to distinguish higher performers. The higher performing sites reported being the most collaborative, due in part to facilitation of system integration by progressive leadership that is willing to build bridges among stakeholders. CONCLUSIONS: Based on the distinguishing features of higher performing sites, we provide recommendations for toolkit development to improve survival in prehospital systems of care for OHCA.

Joint Display of Integrated Data Collection for Mixed Methods Research: An Illustration From a Pediatric Oncology Quality Improvement Study.

PURPOSE: Researchers often struggle to integrate quantitative and qualitative data. Joint displays of data collected using mixed methods provide a framework for supporting integration, yet the literature lacks methodologic articles illustrating in detail the iterative nature of constructing such displays. We demonstrate the process for creating a joint display for integrating the collection of data obtained by qualitative and quantitative methods. METHODS: Within a convergent mixed methods cohort study, the Early Discharge of Febrile Neutropenic Children with Cancer Study, we constructed a joint display to inform integrated collection of 2 forms of data (quantitative and qualitative) from 2 sources (a patient-caregiver mixed methods survey and a manual abstraction of medical records). RESULTS: In a first step, we used a data sources table to align related quantitative and qualitative data. The resulting table consisted of 2 side-by-side columns based on the mixed survey data. After several additional iterative steps, we constructed a final 6-column joint display. This final display delineated the separate data sources, linked constructs to the quantitative and qualitative variables within each source, and integrated the constructs across the separate data sources. CONCLUSIONS: Challenges of integration, though not unique to prospective mixed methods cohort studies, stem from the sheer volume of qualitative and quantitative information and the need to logically organize the data in preparation for integrated data analysis. Tailoring joint displays to specific studies is challenging, but mixed methods researchers who embrace the methodologic malleability can produce effective joint displays to illustrate the mixed data collection linkages and create a preliminary structure ultimately for organizing mixed data findings.

Knowledge and practices of preconception care among rural Japanese women: findings from a mixed methods investigation.

BACKGROUND: Preconception care is not widespread in Japan and there is a pressing need to improve the practice. The present study assessed the knowledge and behavior of preconception care among women to seek effective intervention. Our research questions were: 1) How much do women know about preconception care? 2) How much are they practicing preconception care and what are the information sources of their behavior? 3) Do the women's preconception care behavior associated with accurate knowledge? METHODS: The research was conducted in a rural town in central Japan. Using an exploratory sequential mixed methods design, we undertook interviews, developed a survey based on the qualitative results, and then conducted a survey. The interviews explored how preconception care was perceived and practiced in women of childbearing age. The survey was designed to investigate the knowledge of preconception care among women with and without pregnancy experience, their practice behavior of preconception care, and whether the behavior is associated with knowledge. RESULTS: The participants were 13 for the interview and 232 for the survey. They had limited access to preconception care recommendations and advice for specific actions was given by obstetricians and gynecologists after pregnancy. There was a large gap in knowledge about preconception care between parous and nulliparous women, especially about the need for folic acid supplementation. Practices that were manageable in their daily lives, such as cessation of smoking and alcohol, diet, and weight management, were considered common sense. In contrast, recommended practices that require medical attention, such as screening for sexually transmitted diseases and cervical cancer, tended to be less accurately known and practiced. Participants' sources of information about preconception care were the Internet, family and friends and mass media. CONCLUSION: In rural Japan, women of childbearing age lack knowledge about preconception care, especially before their first pregnancy. Primary care providers should try outreach to schools and women's groups in the community, promote information sharing among family and close friends, and utilize information technology to enhance the knowledge and practice of preconception care.

General Practitioners' Perspectives on Appropriate Use of Ultrasonography in Primary Care in Denmark: A Multistage Mixed Methods Study.

PURPOSE: Researchers aimed to describe general practitioners' understanding of appropriate ultrasound use, to record actual scanning practices of early adopters in general practice, and to identify differences between attitudes and actual practice via a mixed methods analysis. METHODS: This study was part of a larger multistage mixed methods research framework exploring the use of ultrasound in general practice in Denmark. We used an exploratory sequential approach in the data collection with initial qualitative findings from an interview study applied to building a quantitative questionnaire utilized in a cohort study. In addition, we merged the qualitative and quantitative data using joint display analysis to compare and contrast the results from the 2 stages of the study. RESULTS: In the interviews, general practitioners described appropriate ultrasound use as point-of-care examinations with a clear purpose and limited to predefined specific conditions within delimited anatomic areas. They stated that general practitioners should receive formalized ultrasound training and be skilled in the examinations they perform. In the cohort study, general practitioners performed ultrasound examinations of anatomic areas with or without a defined clinical suspicion. Some performed ultrasound examinations for which they had no previous training or skills. CONCLUSIONS: We found a difference between the ideas about the appropriate uses for ultrasound in general practice and the actual use by early adopters in clinical practice. Our findings suggest a need for evidence-based guidelines to support general practitioners in choosing which examinations to perform and strategies for developing and maintaining scanning competency.

How health systems facilitate patient-centered care and care coordination: a case series analysis to identify best practices.

Large- and small-scale transformation of healthcare delivery toward improved patient experience through promotion of patient-centered and coordinated care continues to be at the forefront of health system efforts in the United States. As part of a Quality Improvement (QI) project at a large, midwestern health system, a case series of high-performing organizations was explored with the goal of identifying best practices in patient-centered care and/or care coordination (PCC/CC). Identification of best practices was done through rapid realist review of peer-reviewed literature supporting three PCC/CC interventions per case. Mechanisms responsible for successful intervention outcomes and associated institutional-level facilitators were evaluated, and cross-case analysis produced high-level focus items for health system leadership, including (1) institutional values surrounding PCC/CC, (2) optimization of IT infrastructure to enhance performance and communication, (3) pay structures and employment models that enhance accountability, and (4) organizing bodies to support implementation efforts. Health systems may use this review to gain insight into how institutional-level factors may facilitate small-scale PCC/CC behaviors, or to conduct similar assessments in their own QI projects. Based on our analysis, we recommend health systems seeking to improve PCC/CC at any level or scale to evaluate how IT infrastructure affects provider-provider and provider-patient communication, and the extent to which institutional prioritization of PCC/CC is manifest and held accountable in performance feedback, incentivization, and values shared among departments and settings. Ideally, this evaluation work should be performed and/or supported by cross-department organizing bodies specifically devoted to PCC/CC implementation work.

Challenging procedures used in systematic reviews by promoting a case-based approach to the analysis of qualitative methods in nursing trials.

This methodological discussion invites critical reflection about the procedures used to analyze the contribution of qualitative and mixed methods research to nursing trials by mounting an argument that these should rest on multiple publications produced about a project, rather than a single article. We illustrate the value-added of this approach with findings from a qualitative, cross-case analysis of three critical case exemplars from nursing researchers that each used a qualitative approach with a mixed method phase. The holistic lens afforded by a case-based approach informs nursing inquiry by documenting that the critical case exemplars presented evidence of (a) a sustained commitment of resources and expertise for the qualitative methods that extended across more than one phase of the trial, (b) the impact of the qualitative methods on the trial or its aftermath, (c) deploying a theoretical or conceptual framework for a variety of purposes, and (d) integrating qualitative and quantitative data for purposes of extending explanatory power. Findings challenge the practice of linking purposes served by qualitative and mixed methods to a single trial phase.

The 3 Cs of Content, Context, and Concepts: A Practical Approach to Recording Unstructured Field Observations.

Most primary care researchers lack a practical approach for including field observations in their studies, even though observations can offer important qualitative insights and provide a mechanism for documenting behaviors, events, and unexpected occurrences. We present an overview of unstructured field observations as a qualitative research method for analyzing material surroundings and social interactions. We then detail a practical approach to collecting and recording observational data through a "3 Cs" template of content, context, and concepts. To demonstrate how this method works in practice, we provide an example of a completed template and discuss the analytical approach used during a study on informed consent for research participation in the primary care setting of Qatar.

Perspectives on disclosure of the dementia diagnosis among primary care physicians in Japan: a qualitatively driven mixed methods study.

BACKGROUND: The number of dementia patients in Japan is projected to reach seven million by 2025. While modern ethicists have largely reached the conclusion that full disclosure of dementia serves the best interest of patient, the implications of disclosure of a dementia diagnosis remains an underexplored area of research in Japan. The purpose of this study was to explore primary care physicians' perspectives relative to the practice of disclosure of the dementia diagnosis. METHODS: In this qualitatively driven mixed methods project, we conducted semi-structured interviews with 24 primary care physicians using purposeful sampling to identify rural and urban representation. All interview recordings were transcribed verbatim and analyzed thematically. The research team iteratively conducted discussions of the concepts as they emerged until reaching thematic saturation. The summary was distributed to the participants for member checking and we incorporated their feedback into the final analysis. RESULTS: Of 24 participants, 12 practice in rural areas and 12 practice in urban/suburban areas. Participants' attitudes varied in whether or not to disclose dementia diagnosis to the patients, and in the level of clarity of the name and the prognosis of the disease. Participants who were more comfortable in practicing disclosure were communicating collectively to the patients and their family members and those who were less comfortable practicing disclosure were concerned about patients' feelings and had negative perceptions given the insidious progression of the disease. CONCLUSION: We found substantive individual differences in the approach to disclosure of the diagnosis of dementia and the level of comfort among primary care physicians. More dialogue about this issue and training to equip primary care physicians lacking confidence in their approach may be required.

Medical Students' Experiences and Outcomes Using a Virtual Human Simulation to Improve Communication Skills: Mixed Methods Study.

BACKGROUND: Attending to the wide range of communication behaviors that convey empathy is an important but often underemphasized concept to reduce errors in care, improve patient satisfaction, and improve cancer patient outcomes. A virtual human (VH)-based simulation, MPathic-VR, was developed to train health care providers in empathic communication with patients and in interprofessional settings and evaluated through a randomized controlled trial. OBJECTIVE: This mixed methods study aimed to investigate the differential effects of a VH-based simulation developed to train health care providers in empathic patient-provider and interprofessional communication. METHODS: We employed a mixed methods intervention design, involving a comparison of 2 quantitative measures-MPathic-VR-calculated scores and the objective structured clinical exam (OSCE) scores-with qualitative reflections by medical students about their experiences. This paper is a secondary, focused analysis of intervention arm data from the larger trial. Students at 3 medical schools in the United States (n=206) received simulation to improve empathic communication skills. We conducted analysis of variance, thematic text analysis, and merging mixed methods analysis. RESULTS: OSCE scores were significantly improved for learners in the intervention group (mean 0.806, SD 0.201) compared with the control group (mean 0.752, SD 0.198; F1,414=6.09; P=.01). Qualitative analysis revealed 3 major positive themes for the MPathic-VR group learners: gaining useful communication skills, learning awareness of nonverbal skills in addition to verbal skills, and feeling motivated to learn more about communication. Finally, the results of the mixed methods analysis indicated that most of the variation between high, middle, and lower performers was noted about nonverbal behaviors. Medium and high OSCE scorers most often commented on the importance of nonverbal communication. Themes of motivation to learn about communication were only present in middle and high scorers. CONCLUSIONS: VHs are a promising strategy for improving empathic communication in health care. Higher performers seemed most engaged to learn, particularly nonverbal skills.

Mixed methods in public health research in Taiwan - Using visual diagrams to communicate complex design procedures.

Scholars introduce modern mixed methods research (MMR) and its application in public health research in Taiwan. Specifically, they showcase a multi-phased Taiwan cervical cancer screening mixed methods study using visual diagrams to communicate complex design procedures. While some previous researchers have incorporated quantitative and qualitative data in research, here we hope to provide significant clarity to guide those new to the MMR field. We have structured the article in the following way. First, we provide a brief overview of MMR. Second, we illustrate the compelling need for MMR from a public health perspective using cancer screenings as an example. Third, we introduce the Taiwan cervical cancer screening program as an exemplar of MMR application and the utility of visual diagrams. Study methodology can be applied to international researchers and scholars from interdisciplinary fields beyond public health.

A conceptual model for the development process of confirmatory adaptive clinical trials within an emergency research network.

BACKGROUND: Adaptive clinical trials use accumulating data from enrolled subjects to alter trial conduct in pre-specified ways based on quantitative decision rules. In this research, we sought to characterize the perspectives of key stakeholders during the development process of confirmatory-phase adaptive clinical trials within an emergency clinical trials network and to build a model to guide future development of adaptive clinical trials. METHODS: We used an ethnographic, qualitative approach to evaluate key stakeholders' views about the adaptive clinical trial development process. Stakeholders participated in a series of multidisciplinary meetings during the development of five adaptive clinical trials and completed a Strengths-Weaknesses-Opportunities-Threats questionnaire. In the analysis, we elucidated overarching themes across the stakeholders' responses to develop a conceptual model. RESULTS: Four major overarching themes emerged during the analysis of stakeholders' responses to questioning: the perceived statistical complexity of adaptive clinical trials and the roles of collaboration, communication, and time during the development process. Frequent and open communication and collaboration were viewed by stakeholders as critical during the development process, as were the careful management of time and logistical issues related to the complexity of planning adaptive clinical trials. CONCLUSION: The Adaptive Design Development Model illustrates how statistical complexity, time, communication, and collaboration are moderating factors in the adaptive design development process. The intensity and iterative nature of this process underscores the need for funding mechanisms for the development of novel trial proposals in academic settings.

Patient Perspectives on Language Discordance During Healthcare Visits: Findings From the Extremely High-Density Multicultural State of Qatar.

Reducing language and cultural barriers in healthcare are significant factors in resolving health disparities. Qatar's rapidly growing multicultural population presents new challenges to the healthcare system. The purpose of this research was to explore patients' perspectives about language discordance, and the strategies used to overcome language barriers during patients' visits. Participants were recruited and interviewed from four language groups (Arabic = 24, English = 20, Hindi = 20, and Urdu = 20), all of whom were living in Qatar and utilizing Hamad General Hospital-Outpatient Clinics as a source of their healthcare services. Using qualitative analysis procedures, relevant themes and codes were generated and data analyzed using Atlas-ti. As for results, most participants had experienced or witnessed language barriers during their outpatient clinics visits. Participants essentially were unfamiliar with professional medical interpreters and described their adaptive solutions, for example utilizing incidental interpreters, stringing together fragments of multiple languages, and using body language. Those not speaking mainstream languages of Hamad General Hospital (English and Arabic) were more vulnerable to health disparities due to language barriers. Despite the patient impetus to do something, patient-reported adaptive strategies could compromise patients' safety and access to quality healthcare. Polices tackling the language barrier need to be reviewed in Qatar's multicultural healthcare system and similar settings.

Traditional Arabic & Islamic medicine: validation and empirical assessment of a conceptual model in Qatar.

BACKGROUND: Evidence indicates traditional medicine is no longer only used for the healthcare of the poor, its prevalence is also increasing in countries where allopathic medicine is predominant in the healthcare system. While these healing practices have been utilized for thousands of years in the Arabian Gulf, only recently has a theoretical model been developed illustrating the linkages and components of such practices articulated as Traditional Arabic & Islamic Medicine (TAIM). Despite previous theoretical work presenting development of the TAIM model, empirical support has been lacking. The objective of this research is to provide empirical support for the TAIM model and illustrate real world applicability. METHODS: Using an ethnographic approach, we recruited 84 individuals (43 women and 41 men) who were speakers of one of four common languages in Qatar; Arabic, English, Hindi, and Urdu, Through in-depth interviews, we sought confirming and disconfirming evidence of the model components, namely, health practices, beliefs and philosophy to treat, diagnose, and prevent illnesses and/or maintain well-being, as well as patterns of communication about their TAIM practices with their allopathic providers. RESULTS: Based on our analysis, we find empirical support for all elements of the TAIM model. Participants in this research, visitors to major healthcare centers, mentioned using all elements of the TAIM model: herbal medicines, spiritual therapies, dietary practices, mind-body methods, and manual techniques, applied singularly or in combination. Participants had varying levels of comfort sharing information about TAIM practices with allopathic practitioners. CONCLUSIONS: These findings confirm an empirical basis for the elements of the TAIM model. Three elements, namely, spiritual healing, herbal medicine, and dietary practices, were most commonly found. Future research should examine the prevalence of TAIM element use, how it differs among various populations, and its impact on health.

Split-Session Focus Group Interviews in the Naturalistic Setting of Family Medicine Offices.

PURPOSE: When recruiting health care professionals to focus group interviews, investigators encounter challenges such as busy clinic schedules, recruitment, and a desire to get candid responses from diverse participants. We sought to overcome these challenges using an innovative, office-based, split-session focus group procedure in a project that elicited feedback from family medicine practices regarding a new preventive services model. This procedure entails allocating a portion of time to the entire group and the remaining time to individual subgroups. We discuss the methodologic procedure and the implications of using this approach for data collection. METHODS: We conducted split-session focus groups with physicians and staff in 4 primary care practices. The procedure entailed 3 sessions, each lasting 30 minutes: the moderator interviewed physicians and staff together, physicians alone, and staff alone. As part of the focus group interview, we elicited and analyzed participant comments about the split-session format and collected observational field notes. RESULTS: The split-session focus group interviews leveraged the naturalistic setting of the office for context-relevant discussion. We tested alternate formats that began in the morning and at lunchtime, to parallel each practice's workflow. The split-session approach facilitated discussion of topics primarily relevant to staff among staff, topics primarily relevant to physicians among physicians, and topics common to all among all. Qualitative feedback on this approach was uniformly positive. CONCLUSION: A split-session focus group interview provides an efficient, effective way to elicit candid qualitative information from all members of a primary care practice in the naturalistic setting where they work.

Patient responses to research recruitment and follow-up surveys: findings from a diverse multicultural health care setting in Qatar.

BACKGROUND: Health care researchers working in the Arabian Gulf need information on how to optimize recruitment and retention of study participants in extremely culturally diverse settings. Implemented in Doha, Qatar in 2012 with 4 language groups, namely Arabic, English, Hindi, and Urdu, this research documents persons' responses to recruitment, consent, follow-up, and reminder procedures during psychometric testing of the Multicultural Assessment Instrument (MAI), a novel self- or interviewer-administered survey. METHODS: Bilingual research assistants recruited adults in outpatient clinics by approaching persons in particular who appeared to be from a target language group. Participants completed the MAI, a second acculturation instrument used for content-validity assessment, and a demographics questionnaire. Participants were asked to take the MAI again in 2-3 weeks, in person or by post, to assess test-retest reliability. Recruitment data were analyzed by using nonparametric statistics. RESULTS: Of 1503 persons approached during recruitment, 400 enrolled (27%)-100 per language group. The enrollment rates in the language groups were: Arabic-32%; English-33%; Hindi-18%; Urdu-30%. The groups varied somewhat in their preferences regarding consent procedure, follow-up survey administration, contact mode for follow-up reminders, and disclosure of personal mailing address (for postal follow-up). Over all, telephone was the preferred medium for follow-up reminders. Of 64 persons who accepted a research assistant's invitation for in-person follow-up, 40 participants completed the interview (follow-up rate, 63%); among 126 persons in the postal group with a deliverable address, 29 participants mailed back a completed follow-up survey (response rate, 23%). CONCLUSIONS: Researchers in the Arabian Gulf face challenges to successfully identify, enroll, and retain eligible study participants. Although bilingual assistants-often from the persons' own culture-recruited face-to-face, and our questionnaire contained no health care-related content, many persons were reluctant to participate. This occurrence was observed especially at follow-up, particularly among participants who had agreed to follow-up by post.

Brief gatekeeper training for suicide prevention in an ethnic minority population: a controlled intervention.

BACKGROUND: Suicide is a critical public health problem around the globe. Asian populations are characterized by elevated suicide rates and a tendency to seek social support from family and friends over mental health professionals. Gatekeeper training programs have been developed to train frontline individuals in behaviors that assist at-risk individuals in obtaining mental health treatment. The purpose of this study is to assess the efficacy of a brief, multi-component gatekeeper intervention in promoting suicide prevention in a high-risk Asian community in the United States. METHODS: We adapted an evidence-based gatekeeper training into a two-hour, multi-modal and interactive event for Japanese-Americans and related stakeholders. Then we evaluated the intervention compared to an attention control using mixed methods. RESULTS: A sample of 106 community members participated in the study. Intervention participants (n = 85) showed significant increases in all three types of intended gatekeeper behavior, all four measures of self-efficacy, and both measures of social norms relevant to suicide prevention, while the control group (n = 48) showed no significant improvements. Additional results showed significantly higher satisfaction and no adverse experiences associated with the gatekeeper training. The separate collection of qualitative data, and integration with the quantitative survey constructs confirmed and expanded understanding about the benefits of the intervention. CONCLUSIONS: A brief, multi-modal gatekeeper training is efficacious in promoting positive gatekeeper behaviors and self-efficacy for suicide prevention in an at-risk ethnic minority population of Japanese Americans.

Integrating Quantitative and Qualitative Results in Health Science Mixed Methods Research Through Joint Displays.

PURPOSE: Mixed methods research is becoming an important methodology to investigate complex health-related topics, yet the meaningful integration of qualitative and quantitative data remains elusive and needs further development. A promising innovation to facilitate integration is the use of visual joint displays that bring data together visually to draw out new insights. The purpose of this study was to identify exemplar joint displays by analyzing the various types of joint displays being used in published articles. METHODS: We searched for empirical articles that included joint displays in 3 journals that publish state-of-the-art mixed methods research. We analyzed each of 19 identified joint displays to extract the type of display, mixed methods design, purpose, rationale, qualitative and quantitative data sources, integration approaches, and analytic strategies. Our analysis focused on what each display communicated and its representation of mixed methods analysis. RESULTS: The most prevalent types of joint displays were statistics-by-themes and side-by-side comparisons. Innovative joint displays connected findings to theoretical frameworks or recommendations. Researchers used joint displays for convergent, explanatory sequential, exploratory sequential, and intervention designs. We identified exemplars for each of these designs by analyzing the inferences gained through using the joint display. Exemplars represented mixed methods integration, presented integrated results, and yielded new insights. CONCLUSIONS: Joint displays appear to provide a structure to discuss the integrated analysis and assist both researchers and readers in understanding how mixed methods provides new insights. We encourage researchers to use joint displays to integrate and represent mixed methods analysis and discuss their value.

Clinical trialist perspectives on the ethics of adaptive clinical trials: a mixed-methods analysis.

BACKGROUND: In an adaptive clinical trial (ACT), key trial characteristics may be altered during the course of the trial according to predefined rules in response to information that accumulates within the trial itself. In addition to having distinguishing scientific features, adaptive trials also may involve ethical considerations that differ from more traditional randomized trials. Better understanding of clinical trial experts' views about the ethical aspects of adaptive designs could assist those planning ACTs. Our aim was to elucidate the opinions of clinical trial experts regarding their beliefs about ethical aspects of ACTs. METHODS: We used a convergent, mixed-methods design employing a 22-item ACTs beliefs survey with visual analog scales and open-ended questions and mini-focus groups. We developed a coding scheme to conduct thematic searches of textual data, depicted responses to visual analog scales on box-plot diagrams, and integrated findings thematically. Fifty-three clinical trial experts from four constituent groups participated: academic biostatisticians (n = 5); consultant biostatisticians (n = 6); academic clinicians (n = 22); and other stakeholders including patient advocacy, National Institutes of Health, and U.S. Food and Drug Administration representatives (n = 20). RESULTS: The respondents recognized potential ethical benefits of ACTs, including a higher probability of receiving an effective intervention for participants, optimizing resource utilization, and accelerating treatment discovery. Ethical challenges voiced include developing procedures so trial participants can make informed decisions about taking part in ACTs and plausible, though unlikely risks of research personnel altering enrollment patterns. CONCLUSIONS: Clinical trial experts recognize ethical advantages but also pose potential ethical challenges of ACTs. The four constituencies differ in their weighing of ACT ethical considerations based on their professional vantage points. These data suggest further discussion about the ethics of ACTs is needed to facilitate ACT planning, design and conduct, and ultimately better allow planners to weigh ethical implications of competing trial designs.