Postconcussive syndrome
Brian Sindelar, Julian E. Bailes in Sports-Related Concussion, 2017
When caring for any athlete after a concussion, it should be emphasized that although they have had a brain injury, they will likely have a full recovery. It is important to stress the recovery process because a negative outlook can lead to worse outcomes. Termed as the “nocebo effect,” it is when a person becomes intensely vigilant and focuses on their symptoms actually causing an increased symptom burden.139 Multiple studies have demonstrated this direct relationship between negative injury perception, increased postconcussive symptom burden, and likelihood of PCS development at 3 and 6 months.140–146 Therefore, during the care of a concussed athlete, it is imperative that attention is focused on the psychological factors that could influence their recovery, such as their outlook on recovery, social support, and coping techniques.147
Designing and Delivering a DTx Clinical Research Program: No Need to Re-invent the Wheel
Oleksandr Sverdlov, Joris van Dam in Digital Therapeutics, 2023
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).
Managing Adverse Effects and Drug Intolerance
Giuseppe Mancia, Guido Grassi, Konstantinos P. Tsioufis, Anna F. Dominiczak, Enrico Agabiti Rosei in Manual of Hypertension of the European Society of Hypertension, 2019
Adverse drug reactions can also be categorized according to their presentation as allergy, drug intolerance or side effect; these terms sometimes overlap. Allergy refers to a systematic response of immunological basis which is understood and studied (17,19,21–24). Side effects are adverse effects of the drug without an immunological background (e.g. cough caused by angiotensin-converting enzyme inhibitors or oedema caused by calcium channel blockers) occurring at normal doses and related to the pharmacological properties of the medication (1,14,15,17). They are quite common and well recognized. Drug intolerance is not so well defined, and its mechanisms of action are not well understood. This type of effect may be due in part to a pharmacological mode of action and in part to the patient’s susceptibility, and refers to any subjective or objective adverse reaction not included in the other two categories (25–28). The nocebo effect – that is, the appearance of an adverse effect after exposure to a non-harmful substance – may be a causative factor related to drug intolerance (29). Special patient characteristics such as anxiety and somatization connected with a nocebo effect can lead to a higher possibility of drug intolerance presentation (27,30). Intolerance to multiple antihypertensive drugs is strongly associated with panic attacks, anxiety and depression, and is also strongly associated with increased psychiatric morbidity (25).
Nudging, the Nocebo Effect, and Ambivalence
Published in The American Journal of Bioethics, 2022
Scott Gelfand
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].
The Evolution of Hypnosis in the Profession of Nursing: We’ve Come a Long Way, Baby, and Still Have a Long Way to Go
Published in American Journal of Clinical Hypnosis, 2019
Linda Thomson
Nurses working in intensive care are caring for patients who are physically and psychologically stressed. Patients are frightened, tense, and often in pain. They may feel powerless, vulnerable, and dependent. The conscious part of the patient’s brain may become overwhelmed and cease to function logically. Information is often misunderstood or interpreted negatively. Nurses who incorporate hypnotic language and hypnotic techniques play a large part in reducing the nocebo effect (Diószeghy, Varga, Fejes, & Pénzes, 2000). Nocebo effects may result from negative suggestive statements (e.g., “You are going to be in a lot of pain after your surgery”; “It will make you sick to your stomach and you will throw up”; “I am going to give you a shot and it is going to hurt”; “This will make you dizzy and you might fall”). The precise use of vague language by a nurse trained in hypnosis can create a positive expectancy, such as “The sensations you feel after surgery will be those of healing and mending and need not bother you.”
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