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Designing and Delivering a DTx Clinical Research Program: No Need to Re-invent the Wheel
Published in Oleksandr Sverdlov, Joris van Dam, Digital Therapeutics, 2023
Colin A. Espie, Alasdair L. Henry
Building on this, a common and straightforward control often implemented in early-stage clinical testing is a “waitlist control.” This is where participants randomized to the control do not receive any intervention at all; however, they are told they will receive the intervention once the trial is completed. Effects can, however, be exaggerated (Mohr et al., 2009; Cunningham et al., 2013; Cuijpers et al., 2016, 2019) with a waitlist control as participants may be less likely to access other treatments or seek help from healthcare professionals knowing they will eventually receive the intervention and as they have been asked to wait to receive an intervention (Furukawa et al., 2014). This, too, raises ethical considerations arising from the fact that an effective intervention may be withheld. Furthermore, and although contested, some have also raised concerns about potential “nocebo” effects resulting from waitlist controls due to more significant improvements being observed in no-treatment controls relative to waitlist participants (Furukawa et al., 2014). A nocebo effect is considered the opposite of a placebo effect, whereby an inactive intervention has harmful effects (Colloca and Miller, 2011). Due to the reasons mentioned above, it is suggested that waitlist controls should not be routinely used to examine the effectiveness of psychotherapy. Therefore, they may be best suited to earlier stage testing (Cristea, 2019).
Pharmacology of Opioids
Published in Pamela E. Macintyre, Stephan A. Schug, Acute Pain Management, 2021
Pamela E. Macintyre, Stephan A. Schug
Placebo and nocebo effects can influence the pain experience and are attributable to the psychosocial context and individual treatment expectations rather than the action of the medication or intervention. They are the results of psychological and biological responses resulting from positive and negative expectations (Darnall & Colloca, 2018). It is appropriate to discuss these responses under the heading of mechanisms of action of opioids, as a major component of the analgesic placebo response is mediated via the endogenous opioid system.
Introduction
Published in Rubin Battino, Using Guided Imagery and Hypnosis in Brief Therapy and Palliative Care, 2020
Hahn (1997) has written about the nocebo effect where expectation is used to harm people. Two quotes follow: The nocebo effect is the causation of sickness (or death) by expectation of sickness (or death) and by associated emotional states. There are two forms of the nocebo effect. In the specific form, the subject experiences a particular negative outcome and that outcome subsequently occurs. … In the generic form, subjects have vague negative expectations. (p. 56)The nocebo phenomenon is a little-recognized facet of culture that may be responsible for a substantial variety of pathology around the world. However, the extent of the phenomenon is not yet known, and evidence is piecemeal and ambiguous. (p. 71)
Real-world outcomes following switching from anti-TNF reference products to biosimilars for the treatment of psoriasis
Published in Journal of Dermatological Treatment, 2023
Rachel C. Ruda, Katherine A. Kelly, Steven R. Feldman
Negative patient attitudes about biosimilars may be a nocebo effect, which is defined by a worsening of symptoms induced by negative expectations toward a therapeutic intervention (31). The nocebo effect has been described in a variety of medical interventions in different fields of medicine including biosimilar therapies and adds an additional barrier to their usage. Inciting factors include a lack of knowledge of the new intervention and a breakdown in patient-physician communication (31). Educating physicians and patients on how each batch of a reference product varies and on real-life findings following a switch to biosimilars may provide reassurance about the utility of biosimilars and mitigate this barrier to usage. Nevertheless, drugs sometimes stop working, and sometimes AEs pop up. If either happens after a switch, the switch may get blamed, even if the event was unrelated to the switch.
Nudging, the Nocebo Effect, and Ambivalence
Published in The American Journal of Bioethics, 2022
The nocebo effect can also play a role when trying to resolve ambivalence. The nocebo effect is a phenomenon whereby informing a patient about the possible side-effects associated with a specific intervention has the potential to increase the likelihood the patient will experience the side-effects. For example, in one study, patients who were told that erectile disfunction is a possible side-effect of beta blockers were ten times more likely to suffer erectile disfunction than those who were not informed that this was a possible side-effect (Silvestri et al. 2003). The nocebo effect poses a dilemma for health care providers. If they do not disclose the relevant side-effect information, they are (arguably) not respecting the obligation to obtain informed consent, which is usually said to be grounded in the obligation to respect patient autonomy. If they do disclose this information, they are (arguably) not respecting the obligation to do no harm or the duty of nonmaleficence.
The global landscape on interchangeability of biosimilars
Published in Expert Opinion on Biological Therapy, 2022
Anurag S. Rathore, James G. Stevenson, Hemlata Chhabra, Chinmoyee Maharana
One factor that may lead to problems with acceptance of biosimilars by patients is the Nocebo effect. The Nocebo effect is the development of adverse effects or worsening of the patient’s condition that occurs in response to treatment but is unrelated to the specific pharmacological action of the drug. The Nocebo effect occurs if patients believe that there may be side effects, and this leads to them actually experiencing them [53]. An online survey conducted by the European Federation of Crohn’s and Ulcerative Colitis Association (EFCCA) reported that only 38% of patients were aware of biosimilars and two-third of the respondents were concerned about safety and efficacy of biosimilars [54]. The Nocebo effect can impair the quality of treatment and reduce the patients’ adherence to the treatment. A study measured safety and effectiveness of infliximab biosimilar implementation with emphasis on nocebo response and patient acceptance. A 12.8% nocebo response was observed after switching to biosimilar from originator infliximab in six month duration [55]. Thus, successful adoption of biosimilars hinges on ensuring that the patients have access to clear and impartial information about interchangeability so that they can make a fully informed decision [56]. The regulatory process for registration of biosimilars should preclude there being any actual clinical differences in efficacy and safety between the reference product and the biosimilar. Thus, patient education on the process and experience with biosimilars should help to circumvent this obstacle to adoption [57,58].