Qualitative methods in early-phase drug trials : data and methods from a trial of N-acetylcysteine in schizophrenia

Objective: The pharmacokinetic profile of a drug often gives little indication of its potential therapeutic application, with many therapeutic uses of drugs being discovered serendipitously while being studied for different indications. As hypothesis-driven, quantitative research methodology is exclusively used in early-phase trials, unexpected but important phenomena may escape detection. In this context, this study aimed to examine the potential for integrating qualitative research methods with quantitative methods in early-phase drug trials. To our knowledge, this mixed methodology has not previously been applied to blinded psychopharmacologic trials.

Method: We undertook qualitative data analysis of clinical observations on the dataset of a randomized, double-blind, placebo-controlled trial of N-acetylcysteine (NAC) in patients with DSM-IV-TR–diagnosed schizophrenia (N = 140). Textual data on all participants, deliberately collected for this purpose, were coded using NVivo 2, and emergent themes were analyzed in a blinded manner in the NAC and placebo groups. The trial was conducted from November 2002 to July 2005.

Results: The principal findings of the published trial could be replicated using a qualitative methodology. In addition, significant differences between NAC- and placebo-treated participants emerged for positive and affective symptoms, which had not been captured by the rating scales utilized in the quantitative trial. Qualitative data in this study subsequently led to a positive trial of NAC in bipolar disorder.

Conclusions: The use of qualitative methods may yield broader data and has the potential to complement traditional quantitative methods and detect unexpected efficacy and safety signals, thereby maximizing the findings of early-phase clinical trial research.

Comparative study of mental model research methods : relationships among ACSMM, SMD, MITOCAR & deep methodologies

Measuring and assessing mental models of individuals and teams requires the capturing and analysis of key latent variables. This paper presents and compares four different research methods (ACSMM, SMD, MITOCAR and DEEP) that capture and create a conceptual representation of individual and team mental models. These methods use qualitative and quantitative techniques to investigate a single comparison of different groups or individuals' mental models with another group's mental model or to investigate the comparison of a group or individuals' mental model with themselves at a later time

The essential role of social theory in qualitative public health research

OBJECTIVE: To define the role of social theory and examine how research studies using qualitative methods can use social theory to generalize their results beyond the setting of the study or to other social groups. APPROACH: The assumptions underlying public health research using qualitative methods derive from a range of social theories that include conflict theory, structural functionalism, symbolic interactionism, the sociology of knowledge and feminism. Depending on the research problem, these and other social theories provide conceptual tools and models for constructing a suitable research framework, and for collecting and analysing data. In combination with the substantive health literature, the theoretical literature provides the conceptual bridge that links the conclusions of the study to other social groups and settings. CONCLUSION: While descriptive studies using qualitative research methods can generate important insights into social experience, the use of social theory in the construction and conduct of research enables researchers to extrapolate their findings to settings and groups broader than the ones in which the research was conducted.

Teaching the Rational Use of Medicines to medical students: a qualitative research

Background: Prescribing is a complex and challenging task that must be part of a logical deductive process based on accurate and objective information and not an automated action, without critical thinking or a response to commercial pressure. The objectives of this study were 1) develop and implement a discipline based on the WHO's Guide to Good Prescribing; 2) evaluate the course acceptance by students; 3) assess the impact that the Rational Use of Medicines (RUM) knowledge had on the students habits of prescribing medication in the University Hospital.Methods: In 2003, the RUM principal, based in the WHO's Guide to Good Prescribing, was included in the official curriculum of the Botucatu School of Medicine, Brazil, to be taught over a total of 24 hours to students in the 4th year. We analyzed the students' feedback forms about content and teaching methodology filled out immediately after the end of the discipline from 2003 to 2010. In 2010, the use of RUM by past students in their medical practice was assessed through a qualitative approach by a questionnaire with closed-ended rank scaling questions distributed at random and a single semistructured interview for content analysis.Results: The discipline teaches future prescribers to use a logical deductive process, based on accurate and objective information, to adopt strict criteria (efficacy, safety, convenience and cost) on selecting drugs and to write a complete prescription. At the end of it, most students considered the discipline very good due to the opportunity to reflect on different actions involved in the prescribing process and liked the teaching methodology. However, former students report that although they are aware of the RUM concepts they cannot regularly use this knowledge in their daily practice because they are not stimulated or even allowed to do so by neither older residents nor senior medical staff.Conclusions: This discipline is useful to teach RUM to medical students who become aware of the importance of this subject, but the assimilation of the RUM principles in the institution seems to be a long-term process which requires the involvement of a greater number of the academic members.

Quantitative and qualitative research approaches to assess student well-being

Although there is dissimiliarity in theoretical research approaches to subjective well-being and to assessments of well-being, there is agreement regarding the value of well-being, especially among student populations. In the highly structured, achievement-oriented, non-optimal context of a classroom, individual well-being is a necessary pre-condition for learning. Among student populations well-being should not be construed as an achievement enhancer; but, rather, recognized and measured as an educational value of its own. However, it is necessary for the positive bias towards learning at least in highly structured, achievement-orientated, non-optional learning contexts like school [cf. Hascher, T. (2004). Wohlbefinden in der Schule. Münster: Waxmann]. How can it be measured? Since different research approaches lead to a variety of instruments, the following paper will focus on two ways of assessing well-being in school: a questionnaire on student well-being (N = 2014) 1 and a semi-structured daily diary about relevant emotional situations in school (N = 58, period 3 × 2 weeks). Both methods are introduced and their methodological quality is discussed in terms of reliability, validity and in terms of their usefulness for improving school practice. Furthermore, the research potential of combining quantitative and qualitative data on students’ well-being is addressed.

Immigrant students’ psychological adjustment in the school context: A meta-synthesis of qualitative research on acculturation

This contribution focuses on the characteristics of the school context and their impact on immigrant students’ acculturation and adjustment at school. Research suggests that the ways immigrants acculturate is related to their well being (e.g. Phinney, et al., 2001; Ward & Rana-Deuba, 1999), although findings have been contradictory across methods and studies (e.g. Rogler, 1991; Escobar & Vega, 2001). Debates in acculturation research currently center on issues of acculturation measurement (e.g. Berry, 2009; Rudmin, 2009), as most research is conducted in the quantitative tradition. In addition, some have suggested (Birman, 2011) that research on acculturation in the tradition of cross-cultural psychology adopts an overly individualistic perspective, and lacks attention to the specific contexts of acculturation. Alternatively, the contextual approach proposes that the relationship between acculturation and adjustment is shaped by the surrounding context (Birman & Simon, 2013). For immigrant children, schools are the setting where the process of acculturation unfolds, and an important context in which to study their adjustment and well being (Birman, et al., 2007; Makarova & Herzog, 2011). Though rarely used in this tradition of acculturation research (Chirkov, 2009), qualitative methods are uniquely suited to gain insight to facilitate theory development, as well as appreciate the contextual nature of the acculturation process. Yet we are not aware of efforts to synthesize the empirical qualitative literature on this topic. Applying the methodology of meta-synthesis for qualitatieve research (Walsh & Downe, 2005) our contribution attempts to integrate results from qualitative studies on impact of acculturation on immigrant students’ psychological adjustment in the school context. For this purpose 84 articles which matched the inclusion criteria were selected. Overall, the results of our study show that within the school context a number of structural as well as process characteristics can be identified as crucial for immigrant youth psychological adjustment. Moreover, our findings indicate that immigrant youths’ psychological adjustment is related to other individual outcomes of acculturation in the school context such as behavioral adjustment, peer-relationships, academic achievement and identity development of immigrant youth.

An Exploratory Qualitative Research Study on Resilience and Healing for Asian, Pacific Islander & South Asian Adult Survivors of Child Sexual Abuse

Thesis (Master's)--University of Washington, 2016-06

Postcolonialism and the politics of qualitative research in international business

This paper offers a re-configuration of international business research by subjecting it to a postcolonial critique. This critique sees international business research as exhibiting continuities with the colonial project in the way it appropriates the Other. Qualitative research in international business often reproduces a neopositivist separation of theory and method, which can marginalize discussion of the important ontological, epistemological and political issues inherent in any research process

Finding common ground in team-based qualitative research using the convergent interviewing method

Research councils, agencies, and researchers recognize the benefits of team-based health research. However, researchers involved in large-scale team-based research projects face multiple challenges as they seek to identify epistemological and ontological common ground. Typically, these challenges occur between quantitative and qualitative researchers but can occur between qualitative researchers, particularly when the project involves multiple disciplinary perspectives. The authors use the convergent interviewing technique in their multidisciplinary research project to overcome these challenges. This technique assists them in developing common epistemological and ontological ground while enabling swift and detailed data collection and analysis. Although convergent interviewing is a relatively new method described primarily in marketing research, it compares and contrasts well with grounded theory and other techniques. The authors argue that this process provides a rigorous method to structure and refine research projects and requires researchers to identify and be accountable for developing a common epistemological and ontological position.

A discussion of ethnographic research methods and their relevance for the translation process

In recent years, technologically advanced methodologies such as Translog have gained a lot of ground in translation process research. However, in this paper it will be argued that quantitative research methods can be supplemented by ethnographic qualitative ones so as to enhance our understanding of what underlies the translation process. Although translation studies scholars have sometimes applied an ethnographic approach to the study of translation, this paper offers a different perspective and considers the potential of ethnographic research methods for tapping cognitive and behavioural aspects of the translation process. A number of ethnographic principles are discussed and it is argued that process researchers aiming to understand translators’ perspectives and intentions, how these shape their behaviours, as well as how translators reflect on the situations they face and how they see themselves, would undoubtedly benefit from adopting an ethnographic framework for their studies on translation processes.

The problem of appraising qualitative research

Qualitative research can make a valuable contribution to the study of quality and safety in health care. Sound ways of appraising qualitative research are needed, but currently there are many different proposals with few signs of an emerging consensus. One problem has been the tendency to treat qualitative research as a unified field. We distinguish universal features of quality from those specific to methodology and offer a set of minimally prescriptive prompts to assist with the assessment of generic features of qualitative research. In using these, account will need to be taken of the particular method of data collection and methodological approach being used. There may be a need for appraisal criteria suited to the different methods of qualitative data collection and to different methodological approaches. These more specific criteria would help to distinguish fatal flaws from more minor errors in the design, conduct, and reporting of qualitative research. There will be difficulties in doing this because some aspects of qualitative research, particularly those relating to quality of insight and interpretation, will remain difficult to appraise and will rely largely on subjective judgement.

Finding qualitative research: an evaluation of search strategies

Background Qualitative research makes an important contribution to our understanding of health and healthcare. However, qualitative evidence can be difficult to search for and identify, and the effectiveness of different types of search strategies is unknown. Methods Three search strategies for qualitative research in the example area of support for breast-feeding were evaluated using six electronic bibliographic databases. The strategies were based on using thesaurus terms, free-text terms and broad-based terms. These strategies were combined with recognised search terms for support for breast-feeding previously used in a Cochrane review. For each strategy, we evaluated the recall (potentially relevant records found) and precision (actually relevant records found). Results A total yield of 7420 potentially relevant records was retrieved by the three strategies combined. Of these, 262 were judged relevant. Using one strategy alone would miss relevant records. The broad-based strategy had the highest recall and the thesaurus strategy the highest precision. Precision was generally poor: 96% of records initially identified as potentially relevant were deemed irrelevant. Searching for qualitative research involves trade-offs between recall and precision. Conclusions These findings confirm that strategies that attempt to maximise the number of potentially relevant records found are likely to result in a large number of false positives. The findings also suggest that a range of search terms is required to optimise searching for qualitative evidence. This underlines the problems of current methods for indexing qualitative research in bibliographic databases and indicates where improvements need to be made.

New business histories! Plurality in business history research methods

We agree with de Jong et al.'s argument that business historians should make their methods more explicit and welcome a more general debate about the most appropriate methods for business historical research. But rather than advocating one ‘new business history’, we argue that contemporary debates about methodology in business history need greater appreciation for the diversity of approaches that have developed in the last decade. And while the hypothesis-testing framework prevalent in the mainstream social sciences favoured by de Jong et al. should have its place among these methodologies, we identify a number of additional streams of research that can legitimately claim to have contributed novel methodological insights by broadening the range of interpretative and qualitative approaches to business history. Thus, we reject privileging a single method, whatever it may be, and argue instead in favour of recognising the plurality of methods being developed and used by business historians – both within their own field and as a basis for interactions with others.

The experiences of con sultations on oral anticoagula-tion for AF:the importance of qualitative research incardiovascular sciences

Objectives: Multiple-perspective qualitative designs can aid researchersto develop a more multifaceted account of a phenomenon and as aform of triangulation of data. Two interlinking studies aimed toexplore patients’ and physicians’ experiences of atrial fibrillation (AF)and warfarin.Methods: Audio-recorded semistructured individual interviews wereused. Study 1: Three AF patient subgroups were interviewed (n = 11);accepted, refused, or discontinued warfarin. Study 2: Four physiciansubgroups (n = 16): consultant cardiologists, consultant general physi-cians, general practitioners, and cardiology registrars. Data was ana-lyzed using interpretative phenomenological analysis, a qualitativemethodology.Results: Study 1: Three overarching themes comprised patients’ experi-ences: the initial consultation, life after the consultation, and patients’reflections. Patients commented on the reassurance experienced duringthe consultation, but they perceived the decision-making processmostly led by the physician. Lack of education and take-home materi-als during the initial consultation were highlighted. Patients’ uptake ofinformation was influenced by past experiences and knowledge ofstroke and/or bleeding. Study 2: Two overarching themes covered phy-sicians’ experiences: communicating information and challenges withwarfarin prescription for AF. Physicians’ approach to the consultationstyle shifted through a continuum of compliance-adherence-concor-dance during the consultation. Time and the perceived patient trust inthem as the expert led to physicians to adopt a paternalistic approach.Guideline adherence and the need to adopt a multidisciplinaryapproach were pointed out as current challenges.Conclusion: There is a need to target patients’ and physicians’ abilityto communicate with each other in a comprehensible way. This projecthas illustrated the benefit of using a qualitative approach to under-stand the lived experience of the physician–patient consultation.Disclosure of Interest: None declare