The concept of quality in clinical research

Quality in clinical research may be defined as compliance with requirements together with credibility and reliability of the data obtained. Sponsors usually apply Quality Management Systems (QMS) to ensure, control, maintain, and improve quality. These systems encompass several preventive measures, tools, and controls. Standard QMS applied by clinical research sponsors may be based on ISO 9000. An earlier version of the paper was presented at the 6th International Bioethics Conference on the subject of ‘The Responsible Conduct of Basic and Clinical Research’, held in Warsaw, Poland, 3–4 June 2005.     

Adapting Strauss and Corbin's grounded theory in clinical case study research in the field of counselling

Case study can be adopted when aiming to understand an individual's lived experience. Such experience produces rich and complex qualitative data for analysis, conducive to counselling and psychotherapy research. Furthermore, grounded theory (GT) can be adopted to produce a theory from qualitative data, fitting well with case study research that explores complex experiences regarding social, psychological and phenomenological processes. This paper aims to guide the counselling researcher to incorporate Strauss and Corbin's model into the main arena of qualitative counselling research. In addition, this paper draws on a multiple case study that adopted Strauss and Corbin's method and identified various phases in the GT process. The aim is to inform the reader how to put the iterative process and pragmatic theoretical sampling into practice to produce a robust theory from clinical case study data.     

Searching for the facts in the clinical setting with couples

This paper describes a research proposal to examine whether or not the underlying analytic concepts behind the couple psychoanalytic psychotherapy model used at the Tavistock Marital Studies Institute in London are sufficiently coherent, both conceptually and clinically, to be used as the basis for a system of audit which respects the unique data produced in analytic psychotherapy. This 'psychoanalytic' system of audit is one which is characterized particularly by the use of the therapists' subjectivity, rather than attempts to be objective and gather data through such things as random controlled trials or generic outcome questionnaires. The paper describes the approach to the subject and the mix of qualitative and quantitative methods used. As the Tavistock Marital Studies Institute has a history of contact with Jungian analysts from the Society of Analytical Psychology, Jungian concepts are included in the model. The research is part of a professional doctorate in couple psychoanalytic psychotherapy at the Tavistock Marital Studies Institute in conjunction with the University of East London, entitled 'Conceptualizing audit in Couple Psychoanalytic Psychotherapy'.     

Unconscious fantasy (or phantasy) as clinical concept

A clinical phenomenology of the concept ‘unconscious fantasy’ attempts to describe it from a ‘bottom‐up’ perspective, that is, from the immediate experience of the analyst working in session. Articles of psychoanalytic authors from different persuasions are reviewed, which taken as a whole would shed some light on how the concept of unconscious fantasy takes shape in the analyst's mind during the session with the patient. A clinical phenomenology in three steps is described. Each step is illustrated by clinical material. Current controversies around the concept of unconscious fantasy (or phantasy) are still trapped in the discussion about if and how they are really unconscious. The strategy to describe from a ‘bottom‐up’ perspective the process of how the analyst's mind embraces the idea that an emerging phenomenon in the relationship with the patient can be defined as ‘unconscious fantasy’, allows us to elude the question as to whether or not we believe that unconscious fantasies exist at all, since we are neither required to assert or deny such a prior existence in order to describe the process of elaboration which, in the end, does formulate a fantasy as fantasy.     

Twenty years of experimental philosophy research

This paper reports the first study in the literature that adopts a bibliometric approach to systematically explore the scholarship in the young and fast-growing research field of experimental philosophy. Based on a corpus of 1,248 publications in experimental philosophy from the past two decades retrieved from the PhilPapers website, the study examined the publication trend, the influential experimental philosophers, the impactful works, the popular publication venues, and the major research themes in this subarea of philosophy. It found, first, an overall growing trend in publications in experimental philosophy, encompassing four developmental stages. Second, it found that significant changes in topics of interest have taken place, with some gaining increasing attention, others seemingly going out of fashion, and still others remaining popular constantly. Third, the study identified lists of leading philosophers, frequently cited publications, and popular journals helpful for researchers and newcomers to get a quick start in learning about the field.     

Single case research results as clinical outcomes

The movement toward evidence-based treatments, interventions, or practices pressures single case research (SCR) to use statistical summaries which have broad credibility. These summaries also need to be easily understood and useful in schools and clinics. To date the effect size families, “proportion of variance” (R², Eta²) and “standardized mean difference” (Cohen's d, Hedges' g) have little popularity in SCR. This paper demonstrates a set of alternative Clinical Outcome indices widely used in the field of medicine: Risk Difference, Relative Risk, Relative Risk Improvement, and Odds Ratio, which compare patients in treatment versus control conditions. Translated to SCR designs, the baseline phase becomes the control condition, the intervention phase becomes the treatment condition, and improvement is defined as non-overlapping data between phases. The positive attributes of Clinical Outcomes are demonstrated: (a) easily interpretable results, (b) close relationship with concept of non-overlapping data, (c) minimal data assumptions, (d) minimal statistical expertise required, (e) multiple contrasts possible for diagnostic understanding, (f) exact confidence intervals for results, and (g) close relationship to Pearson R effect size family.     

Developing clinical effectiveness in psychotherapy training: Action research

This study is an evaluation of a new approach to clinical training in Transactional Analysis using the methodology of action research. The evaluation focuses on the second year of training and placement‐based clinical practice at the Metanoia Institute, UK. The design of the training year was research‐based and used the concept of an ‘internship’ year. The design aimed to close the gaps between clinical practice, supervision and formal training; facilitate translation of theory into practice; and integrate findings from the ‘common factors’ research into effectiveness of psychotherapy. Training and supervision methods were linked and focused on emerging issues in clinical practice and the development of students’ capacity for critical reflection and a research attitude to practice. The evaluation was a naturalistic study which used quantitative and qualitative methodology within the action research framework to reflect on the impact of the training on the participants, the organisation and the clinical practice. The quantitative outcomes show that the project developed the effectiveness of students’ clinical practice and reflexivity. Qualitative analysis gives insight into the experiences of the participants and the emotional impact of the research process.     

Time-series analysis in operant research

A time-series method is presented, nontechnically, for analysis of data generated in individual-subject operant studies, and is recommended as a supplement to visual analysis of behavior change in reversal or multiple-baseline experiments. The method can be used to identify three kinds of statistically significant behavior change: (a) changes in score levels from one experimental phase to another, (b) reliable upward or downward trends in scores, and (c) changes in trends between phases. The detection of, and reliance on, serial dependency (autocorrelation among temporally adjacent scores) in individual-subject behavioral scores is emphasized. Examples of published data from the operant literature are used to illustrate the time-series method.     

临床均势原则辨析——对临床科研方法的伦理思考

随机对照试验作为一种评价新疗法的可靠设计方法,开始逐渐被世界范围内的临床医生所广泛接受和采用,成为目前最重要的试验方法之一。RCT的运用应该遵循一定的伦理准则,即临床均势原则。围绕临床均势原则这一主题,对随机对照试验的方法论进行较为深入的伦理学思考。并对临床均势的内涵、伦理意义,以及这一伦理要求在实践中所引发的各种伦理争论加以探讨。     

Placebo: Its action and place in health research today

The place for the placebo in human clinical research is addressed in this paper. The World Medical Association which is comprised of some 80 National Medical Associations uses much of its resources to address medical ethics and human rights issues. It adopted the Declaration of Helsinki in June 1964 which addressed the protection of individuals in clinical trials. The use of placebos assumes an important role in this document. Five Revisions of the Declaration of Helsinki have occurred and the most recent was adopted in October 2000. The provisions on placebo are now in Paragraph 29 which reads as follows: “The benefit, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic or therapeutic methods exists.” The reactions to the newly revised version of the Declaration of Helsinki were numerous and rapid, not the least of which was the paragraph I quoted above. At the direction of the WMA Council, a small group of experts together with the WMA workgroup studied the Paragraph 29 to ensure that no ethically sound research was being restricted by the revision. The outcome was approved by the Council and later the WMA General Assembly in October 2000. This gives a note of clarification as to the appropriate use of placebos. Numerous papers and statements over the last several years have described positions very much in line with the Note of Clarification cited above. This paper was presented at an international conference, “Placebo: Its Action and Place in Health Research Today,” held in Warsaw, Poland on 12–13 April, 2003.     

Conducting a qualitative research on suicide in Ghana using Interpretative Phenomenological Analysis (IPA): A reflection after a decade

Interpretative Phenomenological Analysis (IPA) set of guidelines allow a researcher to gain access to the meaning of a phenomenon (e.g. suicide) through the individual person's lived and personal experiences. In this paper I have discussed that the ethical challenges that confront researching suicide in Ghana the challenges of pursuing an idiographic rigor using the IPA may arise from the pervasive normative self-construal within Ghanaian communities. Though I admit the IPA has been useful in various studies within the African context, I have also interrogated such idiography within the normative social arrangement of such setting where sociocentric perspectives abound. This essay is a reflexivity on the IPA in a normative context after a decade, where suicidal behaviour is strongly proscribed and personhood is deeply shared. I have recommended that one way of addressing this challenge is to use a ‘funnel’ approach in interviewing from the general: the community, to the particular: the individual.     

Grounded Theory methods in child psychotherapy research

This article considers the place of qualitative research in psychoanalysis and child psychotherapy. It discusses why research methodology for many years occupied so small a place in these fields, and examines the cultural and social developments since the 1960s which have changed this situation, giving formal but also qualitative methods of research much greater significance. It reflects on the different pressures to develop explicit research methods which arise both from outside the psychoanalytic field, as a condition of its continued professional survival, and from within it, where its main aim is the development of fundamental psychoanalytic knowledge. It suggests that the conduct of mainly quantitative research into treatment outcomes is largely a response to these external pressures, whilst the main benefits to be gained from the development of qualitative research methods, such as Grounded Theory, are in facilitating the knowledge-generating capacities and achievements of child psychotherapists themselves. The paper describes Grounded Theory methods, and explains how they can be valuable in the recognition of hitherto unrecognised meanings and patterns as these are made visible in clinical practice. Finally, it briefly describes three examples of completed doctoral studies, all of which have added significantly to the knowledge-base of child psychotherapy, and which demonstrate how much can be accomplished using this method of research.     

Managing financial conflicts of interest in clinical research

Upholding public trust in clinical research necessitates that human subjects be protected from avoidable harm and that the design, interpretation and reporting of research results be shielded from avoidable bias. On both counts, managing financial conflicts of interest is critically important, especially in the modern era when the opportunities for investigators to benefit personally from the commercialization of their intellectual property are overtly encouraged and rapidly expanding. Efforts are underway in the United States to provide more useful guidance to universities and medical schools for purposes of strengthening the oversight and management of financial conflicts of interest in clinical research. An earlier version of this paper was presented at an International Conference on “Conflict of Interest and its Significance in Science and Medicine” held in Warsaw, Poland on 5–6 April, 2002.     

Quality Criteria Under Methodological Pluralism: Implications for Conducting and Evaluating Research

Many community psychologists adhere to a methodological pluralist orientation to research; however, it is often unclear what such a position means in practice. This paper draws out the practical implications of methodological pluralism for community research. It proposes four sets of criteria for how research might be appraised under a pluralistic ethos: criteria applicable to all research, research-relevant community psychology values and principles, criteria specifically applicable to quantitative research, and criteria specifically applicable to qualitative research. The paper also addresses how pluralistic community research may be conducted, at each of three levels: integrating methods within a single study, using different approaches within a research program, and pluralism in the field as a whole.     

Ethical Issues and Guidelines for Conducting Data Analysis in Psychological Research

Psychologists are directed by ethical guidelines in most areas of their practice. However, there are very few guidelines for conducting data analysis in research. The aim of this article is to address the need for more extensive ethical guidelines for researchers who are post–data collection and beginning their data analyses. Improper data analysis is an ethical issue because it can result in publishing false or misleading conclusions. This article includes a review of ethical implications of improper data analysis and potential causes of unethical practices. In addition, current guidelines in psychology and other areas (e.g., American Psychological Association and American Statistical Association Ethics Codes) were used to inspire a list of recommendations for ethical conduct in data analysis that is appropriate for researchers in psychology.     

Conducting community‐based participatory research in an urban Malaysian community: Lessons learned and challenges in establishing partnerships

This paper presents the process of how partnerships are established between an urban residential community and an academic institution in Malaysia by employing community‐based participatory research, which involves researchers, community members, and organizational representatives as coresearchers. The research process encompasses colearning, power sharing, and coconstructing of knowledge, with the community members driving the research direction. The research paradigm is grounded on conducting research with the community. This paper highlights the experience and lessons learned while applying the principles of community‐based participatory research that promotes social participation of older persons living in a residential community. Two pertinent challenges surface in the research process. The first challenge involves the complexity noted in the gap between the emancipation of community‐based participatory research and the hierarchical social structure of the society. The second challenge is the prevalence of unspoken yet subtle domination that undermines the local cultural values affecting the process of coconstructing knowledge with the community. Recommendations for addressing these challenges include future partnerships with other Malaysian communities as well as cross‐border research partnerships.