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Critical appraisal of randomized clinical trials
Published in O. Ajetunmobi, Making Sense of Critical Appraisal, 2021
The Hawthorne effect refers to those clinical improvements that occur in study subjects just as a result of being participants in a trial. This phenomenon occurs because mere clinical contact in a study alone can have a positive ‘feel-good’ effect on the way study subjects perceive their symptoms. Needless to say, this effect can produce artificially encouraging data on the beneficial effects experimental and control treatments.
Observing identity
Published in Roger Ellis, Elaine Hogard, Professional Identity in the Caring Professions, 2020
Calum T. McHale, Joanne E. Cecil
Direct observation of clinical interactions is an established research approach within healthcare education and communication and can take the form of live observations of the interaction or audio-visually recording the interaction for subsequent review (Fromme et al., 2009; McHale et al., 2016). Observation of healthcare students interacting with patients is used to assess clinical and communication skills (Kogan et al., 2009) and has been associated with improved student outcomes, such as self-reflection and task performance (Hammoud et al., 2012). Additionally, direct observation is a commonly used approach in healthcare communication research to investigate topics such as patient-centred communication and emotional expression (Epstein et al., 2005; McHale et al., 2019; Zhou et al., 2013). The primary advantage of direct observation when researching behaviours and communication practices is that it negates the subjectivity and risk of bias introduced by relying solely on self-report from the individuals engaging in the interaction. The Hawthorne effect, or observation bias, whereby the knowledge of being observed will result in changes to behaviour, has the potential to introduce bias into this research approach (McCambridge et al., 2014). However, review evidence suggest that direct observation methodologies have minimal impact on healthcare professionals’ behaviour and practices (Themessl-Huber et al., 2008).
Stage 4: Sustaining improvement
Published in Robin Burgess, New Principles of Best Practice in Clinical Audit, 2020
Stephen Ashmore, Tracy Ruthven, Louise Hazelwood
If data have been collected prospectively for the audit, it is important to consider to what extent, if at all, the results have been skewed by changed behaviour during the data collection period. Those whose practice was being audited may have changed their normal practice to that required by the audit standards because they knew that they were being audited. This can lead to falsely high performance levels being achieved that are not a true reflection of normal practice. Where performance levels have been exceeded in an audit of a topic that is known to be a problem, the possibility that the Hawthorne effect may have come into play must be considered before a decision is taken not to continue to collect data.
Association between participation in the Northern Finland Birth Cohorts and cardiometabolic disorders
Published in Annals of Medicine, 2023
Martta Kerkelä, Mika Gissler, Tanja Nordström, Olavi Ukkola, Juha Veijola
In prospective population-based cohort studies, a defined population is selected for longitudinal assessment of exposure-outcome relations. Data collection procedures include clinical examinations, questionnaires, tests, interviews, or linkage to existing data [1]. The Hawthorne effect is a phenomenon that occurs when the mere act of being observed in a study changes the behaviour of the study’s participants. This can impact the validity of the study’s results, as the behaviour that is being observed may not be representative of the participants’ normal behaviour [2]. In the Derbyshire Smoking Study, the Hawthorne effect was observed in a group of approximately 6,000 adolescents whose smoking habits were surveyed with a yearly questionnaire from 1974 to 1978 in selected schools. The findings showed that the prevalence of smoking was lower in schools that had been surveyed for five years [3]. A meta-analysis of 15 studies published between 2012 and 2022 found that the Hawthorne effect is common in medical research, which can limit the study’s external validity and result in gaps in medical knowledge [4]. Nevertheless, whether the intensive follow-ups affect the study population has not been thoroughly studied. The follow-up studies conducted may have a wide range of effects on the target population, even though the purpose of the prospective birth cohort setting is not to intervene but to get a representative sample of the population.
A scoping review of legibility of hand-written prescriptions and drug-orders: the writing on the wall
Published in Expert Review of Clinical Pharmacology, 2023
Anderson Ariaga, Dustin Balzan, Stephen Falzon, Janet Sultana
These studies had several limitations. The most common one was the restricted catchment area, often limited to a single hospital. Another common limitation was that many of the studies were published at least 10 years ago, so they may not reflect recent practices. Another important limitation is that each study used a different metric to measure legibility. Other limitations encountered were the Hawthorne effect for a prospective study [1] and selection bias [18]. The quality of some of the studies is also called into question. For example, two of the studies did not even report the study period or the duration of the study, making the interpretation of results difficult [4,14]. One study assessed legibility in terms of whether there was ‘any difficulty’ in interpreting the writing, which it itself difficult to interpret [16].
Use of pre-enrollment randomization and delayed consent to maximize participation in a clinical trial of opt-in versus opt-out tobacco treatment
Published in Substance Abuse, 2022
Babalola Faseru, Laura M. Mussulman, Niaman Nazir, Edward F. Ellerbeck, Elena Shergina, Taneisha S. Scheuermann, Byron J. Gajewski, Delwyn Catley, Kimber P. Richter
Zelen’s design trials immediately consent prospective participants following randomization, but our current study delayed consent until after treatment—until the one-month follow-up assessment at which the main outcome, biochemically confirmed cigarette smoking abstinence, was assessed. Zelen’s design trials also often consent only the participants randomized to the intervention arm, which can lead to higher rates of refusal in the intervention arm and introduce selection bias. By consenting participants in both groups at one month post randomization we sought to preserve the Zelen’s design benefits of recruiting a broad pool of participants while reducing the risk of differential drop out. Consenting participants at the main study endpoint also reduces the risk of the Hawthorne effect (the potential impact on behavior due to awareness of being in a study) on study outcomes.30