Evidence Derived from Real-World Data: Utility, Constraints, and Cautions
Harry Yang, Binbing Yu in Real-World Evidence in Drug Development and Evaluation, 2021
When properly designed and implemented, sample surveys have external validity, and results obtained from such studies can be generalized to the representative populations of interest. Carefully designed studies such as well-controlled laboratory experiments, in contrast, have internal validity, and results from such studies support causal inferences to be made. Ideally, combining both types of research, which has been termed in social sciences and psychological research as “survey experiments,” has the potential to generate results that will have both internal and external validity, and possess potential to infer causal relationships that may be generalizable. A good reference on the design and application of survey experiments in the social sciences is the book by Mutz (2011). Mutz challenges conventional wisdom about internal and external validity of studies and demonstrates that strong causal claims need not come at the expense of external validity, and that it will be possible to execute experiments remotely using large population samples. In theory, RWD could be used for such purposes in biomedicine.
The role of research ethics committees
Frank Wells, Michael Farthing in Fraud and Misconduct in Biomedical Research, 2019
While the EC Directive refers to clinical trials of investigational medicinal products, its recommendations may be applied to all varieties of health research. There seems no good reason not to include also research involving human participants external to health-care settings. Much psychological research, for example, is pursued in academic units or even in military or industrial settings. RECs may be better regulated, better known, and with a longer history in health care, but recent years have seen the development of other types of ethics committees. In the UK, for example, most universities have some form of ethical scrutiny or are in the process of developing a system to review research on human volunteers outside the remit of the National Health Service (NHS).7 In considering the role of ethics committees in the prevention of fraud or misconduct, those committees outside the NHS may have a similar part to play. Fraud and misconduct may be equally prevalent in settings external to health care.
Old and new approaches
Roger Bradford in Children, Families and Chronic Disease, 2002
In Chapter 1, I suggested that psychological research has become overly focused on what can be described as a 'pathological' model, the underlying assumption being that psychological problems, or 'pathology', are common and therefore the researcher's task is to calibrate the extent of difficulties encountered. There are probably two main reasons why psychological research has pursued this particular line of enquiry. In getting to grips with any 'new' problem area, there is an understandable desire to map out the size of the territory. Not only does this provide useful information in terms of drawing attention to the extent of difficulties experienced but such research can also have implications for the development of new services to meet the problems identified. Thus, having identified a certain number of children as suffering from a chronic disease and delineated the psychological problems that result, it is possible to argue for resources to be allocated to meet likely demand.
Personality changes after acquired brain injury and their effects on rehabilitation outcomes
Published in Neuropsychological Rehabilitation, 2023
Frederike Svensson, Anne Much, Cornelia Exner
Psychological research has put forth various conceptualizations of personality. Among these, the five-factor model of personality (FFM) is universally established and well recognized (McCrae & Costa, 1999). The FFM comprises the “Big Five” personality dimensions of neuroticism, extraversion, openness, agreeableness and conscientiousness. When measuring personality, research has often relied on self- as well as on informant-reports. It is, however, important to acknowledge that these rating-sources rely on different cues and may be biased by the rater’s motives for presentation. While informant ratings are mainly based on outward behavioural cues, internal phenomena (like thoughts and feelings) may be less visible to others and thus only accessible to the self. At the same time, self-ratings are prone to biases caused by motivation for positive self-presentation or a lack of insight. In that respect, informants may provide a more objective assessment of the participant’s behaviours (Mottus et al., 2020). Measuring both self- and informant-ratings may yield the most comprehensive evaluation of personality available via questionnaire assessment.
The debate on medicalization of sexology 2001–2010: a literature study on psychological treatment of sexual problems
Published in Sexual and Relationship Therapy, 2018
While randomized and controlled studies have been widely used in biomedical research, many argued that other forms of evidence are needed in psychological research. The American Psychological Presidential Task Force on Evidence-Based Practice concludes that there are three main factors found in highly effective evidence-based practice in psychology: – Best Available Research Evidence, based on multiple types of research evidence.– Clinical Expertise refers to competence attained by the psychologist through education, training and experience that results in effective practice.– Patient Characteristics, Culture, and Preferences. (Presidential Task Force on Evidence-Based Practice, 2006).This is an understanding that has been acknowledged by several of the authors in the material analyzed this article.
Gender Minority Stress: A Critical Review
Published in Journal of Homosexuality, 2020
Kyle K. H. Tan, Gareth J. Treharne, Sonja J. Ellis, Johanna M. Schmidt, Jaimie F. Veale
Much psychological research is conducted from a cisnormative perspective (Ansara & Hegarty, 2012). Psychological research has presumed being cisgender to be the social norm, and most psychological researchers conceptualize human experience in strictly cisgender terms (Ansara & Hegarty, 2012). Past psychological and medical researchers who have applied a cisnormative framework have at best neglected and invalidated the existence of TGD people. If psychological research assumes the population of interest to be cisgender, it is difficult to examine the issues affecting the TGD populations and to develop measures to address the health and social needs of TGD people. At its worst, psychological and psychiatric research has taken an active anti-trans stance—for example, by attempting to produce evidence of the effectiveness of conversion therapies (Bernal & Coolhart, 2012).
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