scholarly journals Informing About the Nocebo Effect Affects Patients’ Need for Information About Antidepressants—An Experimental Online Study

2021 ◽  
Vol 12 ◽  
Author(s):  
Yvonne Nestoriuc ◽  
Yiqi Pan ◽  
Timm Kinitz ◽  
Ella Weik ◽  
Meike C. Shedden-Mora
Keyword(s):  
Informed Consent ◽  
Side Effects ◽  
Information Seeking ◽  
Side Effect ◽  
Experimental Manipulation ◽  
Informational Needs ◽  
Nocebo Effect ◽  
Chi Square ◽  
Beneficial Effects ◽  
Need For Information

Relevance: Understanding patients’ informational needs and adapting drug-related information are the prerequisites for a contextualized informed consent. Current information practices might rather harm by inducing nocebo effects.Objective: To investigate whether informing about the nocebo effect using a short information sheet affects patients’ need for information about antidepressants.Methods: A total of 97 patients taking recently prescribed antidepressants (≤4 months intake) were recruited over the internet and randomized to receiving either a one-page written information about the nocebo effect or a control text about the history of antidepressants. After experimental manipulation, informational needs about the side effects and mechanisms of antidepressants were assessed with 3 and 7 items on categorical and 5-point Likert scales. Group differences in informational needs were calculated with Chi-square tests and ANOVAs.Results: Patients received antidepressants for depression (84.5%) and/or anxiety disorders (42.3%). Three participants (6.0%) of the nocebo group reported previous knowledge of the nocebo effect. After the experimental manipulation, participants in the nocebo group reported a reduced desire for receiving full side effect information [X(4,97)2 = 12.714, Cramer’s V = 0.362, p = 0.013] and agreed more frequently to the usefulness of withholding information about possible side effects [X(4,97)2 = 14.878, Cramer’s V = 0.392, p = 0.005]. Furthermore, they desired more information about the mechanisms of antidepressants (F = 6.373, p = 0.013, partial η2 = 0.063) and, specifically, non-pharmacological mechanisms, such as the role of positive expectations (F = 16.857, p < 0.001, partial η2 = 0.151).Conclusions: Learning about the nocebo effect can alter patients’ informational needs toward desiring less information about the potential side effects of antidepressants and more information about general mechanisms, such as expectations. The beneficial effects of including nocebo information into contextualized informed consent should be studied clinically concerning more functional information-seeking behavior, which may ultimately lead to improved treatment outcomes, such as better adherence and reduced side effect burden.

scholarly journals Using Positive Attribute Framing to Attenuate Nocebo Side Effects: A Cybersickness Study

2021 ◽  
Author(s):  
Alanna Mao ◽  
Kirsten Barnes ◽  
Louise Sharpe ◽  
Andrew L Geers ◽  
Suzanne G Helfer ◽  
...  
Keyword(s):  
Virtual Reality ◽  
Informed Consent ◽  
Side Effects ◽  
Healthy Volunteers ◽  
Empirical Data ◽  
Side Effect ◽  
Spatial Awareness ◽  
Nocebo Effect ◽  
Positive Attribute ◽  
To Receive

Abstract Background Side effect warnings can contribute directly to their occurrence via the nocebo effect. This creates a challenge for clinicians and researchers, because warnings are necessary for informed consent, but can cause harm. Positive framing has been proposed as a method for reducing nocebo side effects whilst maintaining the principles of informed consent, but the limited available empirical data are mixed. Purpose To test whether positive attribute framing reduces nocebo side effects relative to negative framing, general warning, and no warning. Methods Ninety-nine healthy volunteers were recruited under the guise of a study on virtual reality (VR) and spatial awareness. Participants were randomized to receive positively framed (“7 out of 10 people will not experience nausea”), negatively framed (“3 out of 10 people will experience nausea”), general (“a proportion of people will experience nausea”), or no side effect warnings prior to VR exposure. Results Receiving a side effect warning increased VR cybersickness relative to no warning overall, confirming that warnings can induce nocebo side effects. Importantly, however, positive framing reduced cybersickness relative to both negative framing and the general warning, with no difference between the latter two. Further, there was no difference in side effects between positive framing and no warning. Conclusions These findings suggest that positive framing not only reduces nocebo side effects relative to negative framing and general warnings, but actually prevents nocebo side effects from occurring at all. As such, positive attribute framing may be a cheap and ethical way to reduce nocebo side effects.

The Nocebo Effect and Informed Consent—Taking Autonomy Seriously

2020 ◽  
Vol 29 (2) ◽  
pp. 223-235
Author(s):  
SCOTT GELFAND
Keyword(s):  
Informed Consent ◽  
Side Effects ◽  
Medical Treatment ◽  
Side Effect ◽  
Patient Autonomy ◽  
The Other ◽  
Nocebo Effect ◽  
Other Hand ◽  
Patient Will ◽  
Practical Tool

AbstractThe nocebo effect, a phenomenon whereby learning about the possible side effects of a medical treatment increases the likelihood that one will suffer these side effects, continues to challenge physicians and ethicists. If a physician fully informs her patient as to the potential side effects of a medicine that may produce nocebogenic effects, which is usually conceived of as being a requirement associated with the duty to respect autonomy, she risks increasing the likelihood that her patient will experience these side effects and therefore suffer (unnecessary) harm, a violation of the duty of nonmaleficence. If, on the other hand, she intentionally withholds side effect information in an effort to protect her patient from suffering unnecessary harm from side effects, which is consistent with the duty of nonmaleficence, she violates the duty to respect patient autonomy. In this paper, the author discusses several previous attempts to deal with the nocebo effect and explains their weaknesses. He then proposes a means of managing the nocebo effect and argues that it does not share the weaknesses found in previous approaches. He concludes with a discussion of a simple, yet practical tool that might help clinicians manage the tension resulting from the nocebo effect.

scholarly journals Use of information sources regarding medicine side effects among the general population: a cross-sectional survey

2019 ◽  
Vol 20 ◽  
Author(s):  
Bernadine O’Donovan ◽  
Ruth M. Rodgers ◽  
Anthony R. Cox ◽  
Janet Krska
Keyword(s):  
Side Effects ◽  
Information Seeking ◽  
Side Effect ◽  
Information Sources ◽  
Negative Impact ◽  
Cross Sectional Survey ◽  
Cross Sectional ◽  
Information Leaflets ◽  
Increased Risk ◽  
Use Of Information Sources

Abstract Aim: To determine the use and perceived value of different information sources that patients may use to support identification of medicine side effects; to explore associations between coping styles and use of information sources. Background: Side effects from medicines can have considerable negative impact on peoples’ daily lives. As a result of an ageing UK population and attendant multi-morbidity, an increasing number of medicines are being prescribed for patients, leading to increased risk of unintended side effects. Methods: A cross-sectional survey of patients who use medicine, recruited from community pharmacies. The survey sought views on attributes of various information sources, their predicted and actual use, incorporating a shortened Side Effects Coping Questionnaire (SECope) scale and the abbreviated Miller Behavioural Style Scale (MBSS). Findings: Of 935 questionnaires distributed, 230 (25.0%) were returned, 61.3% from females; 44.7% were retired and 84.6% used at least one medicine regularly. 69.6% had experienced a side effect, resulting in 57.5% of these stopping the medicine. Patient information leaflets (PILs) and GPs were both predicted and actually most widely used sources, despite GPs being judged as relatively less accessible and PILs less trustworthy, particularly by regular medicine users. Pharmacists, considered both easy to access and trustworthy, were used by few in practice, while the internet was considered easy to access, but less trustworthy and was also little used. SECope sub-scales for non-adherence and information seeking showed positive associations with stopping a medicine and seeking information from a health professional. More high monitors than low monitors stopped a medicine themselves, but there were no differences in use of information sources. Information seeking following a side effect is a common strategy, potentially predicted by the SECope, but not the MBSS. Limited GP accessibility could contribute to high internet use. Further research could determine how the trustworthiness of PILs can be improved.

Patient informational needs about breast reconstruction post-mastectomy.

2012 ◽  
Vol 30 (27_suppl) ◽  
pp. 88-88
Author(s):  
Ivy A. Ahmed ◽  
Allison Harvey ◽  
Erica Weiss ◽  
Marni Amsellem
Keyword(s):  
Breast Cancer ◽  
Breast Reconstruction ◽  
Information Seeking ◽  
Breast Cancer Diagnosis ◽  
National Sample ◽  
Informational Needs ◽  
Chi Square ◽  
Reconstructive Procedures ◽  
Cancer Support ◽  
Reconstruction Methods

88 Background: For many women, receiving a breast cancer diagnosis is further complicated by decisions they will face about breast reconstruction post-mastectomy. While women are typically provided with some information about reconstruction options, little is known about the perceived value of this information and how it might ultimately affect their decision about reconstruction. The Cancer Support Community investigated these questions in a national sample of women with breast cancer to better understand their information-seeking experiences, knowledge, and decision-making about reconstruction. Methods: In 2011, 439 participants attending Frankly Speaking about Cancer: Spotlight on Breast Reconstruction, a national educational workshop, completed a post-workshop survey (56.4% response rate). 76.2% of respondents were women diagnosed with breast cancer, who reported their decisions about reconstruction as well as their experience receiving information about reconstruction. Results: Respondents were Caucasian (74.8%), black (11.4%), and Hispanic (10.1%), and the mean age was 48.9. Nearly half (42%) of respondents reported low levels of knowledge about breast reconstruction prior to the workshop. Of those eligible for breast reconstruction, 18.2% reported they had decided against reconstruction, 40.7% were considering their options, and 41.1% planned to undergo or had undergone reconstructive procedures. Women reported they would have liked to have had more information prior to reconstruction about a variety of topics, including more information about the procedure (43.6%), how they would look (31.1%) and feel (29.7%) after reconstruction, and information about their future breast health (31.8%). No differences were found in unmet informational needs based on their reconstruction decisional status with one exception: those who decided against reconstruction were more likely to endorse that they would have wanted more information about when to make their decision about reconstruction than the other two groups (chi square=24.6, p <.01). Conclusions: Findings suggest women facing breast reconstruction often are not equipped with comprehensive information about procedures, options, outcomes, and recovery.

Cutaneous ulcers following hydroxyurea therapy

Phlebologie ◽  
2004 ◽  
Vol 33 (06) ◽  
pp. 202-205 ◽  
Author(s):  
K. Hartmann ◽  
S. Nagel ◽  
T. Erichsen ◽  
E. Rabe ◽  
K. H. Grips ◽  
...  
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Antineoplastic Agent ◽  
Limited Time ◽  
Myeloproliferative Diseases ◽  
Dermatological Side Effects ◽  
Chronic Myeloproliferative Diseases ◽  
Hydroxyurea Therapy

SummaryHydroxyurea (HU) is usually a well tolerated antineoplastic agent and is commonly used in the treatment of chronic myeloproliferative diseases. Dermatological side effects are frequently seen in patients receiving longterm HU therapy. Cutaneous ulcers have been reported occasionally.We report on four patients with cutaneous ulcers whilst on long-term hydroxyurea therapy for myeloproliferative diseases. In all patients we were able to reduce the dose, or stop HU altogether and their ulcers markedly improved. Our observations suggest that cutaneous ulcers should be considered as possible side effect of long-term HU therapy and healing of the ulcers can be achieved not only by cessation of the HU treatment, but also by reducing the dose of hydroxyurea for a limited time.

Side Effects of Chemotherapy and Cancer Treatment in Tertiary Care Teaching Hospital

2016 ◽  
Vol 2 (1) ◽  
pp. 62-78
Author(s):  
. Hemraj ◽  
Raj Kumar ◽  
Sourabh Kosey ◽  
Amit Sharma ◽  
Nalini Negi
Keyword(s):  
Side Effects ◽  
Tertiary Care ◽  
Cross Sectional Study ◽  
Informational Needs ◽  
Cross Sectional ◽  
Clinical Pharmacists ◽  
Medical College ◽  
Related Information ◽  
The Common ◽  
Chemotherapy Patients

To determine the most common physical side effects experienced by local chemotherapy patients. Their perceptions of these side effects and informational needs from clinical pharmacists were also evaluated. This was a single center, observational cross-sectional study conducted at department of General Surgery, Guru Gobind Singh Medical College and Hospital, Faridkot, Punjab. A face to face interview was conducted. Information collected included chemotherapy related side effects after last chemotherapy experience, the most worrisome side effects, overlooked by healthcare professionals and the preferred method, amount and source of receiving related information. In this study, hundred patients were enrolled out of them 48 were male and 52 were female. When differential calculations was done, common side effects or adverse effects of chemotherapy in the patients of breast, lung cancer, Ovarian Cancer, Colon cancer, Prostate cancer, Lymphoma Cancer, Cervix cancer where there is much irregular medicine intake 57.4% may be due to common problem of joint pain reported by all the patients under study, with the consecutive problem of nausea and vomiting. The high prevalence of chemotherapy related side effects among local patients is a major concern and findings of their perceptions and informational needs may serve as a valuable guide for clinical pharmacists and physicians to help in side effect management. This study shows the common problems reported by the patients when they are suffering from cancer condition, according to their incidence perceptions as experienced by the patient, this will allow the physician and clinical pharmacist to effectively counsel and manage the common symptoms as reported prior to its occurrence in the patient, so that withdrawal can be checked.

HUBUNGAN KARAKTERISTIK PASIEN DENGAN PEMAHAMAN PERSETUJUAN TINDAKAN MEDIS PADA TINDAKAN BEDAH DI RUMAH SAKITPERTAMINA BINTANG AMIN (RSPBA) BANDAR LAMPUNG BULAN MARET 2015

2019 ◽  
Vol 6 (1) ◽  
pp. 19-28
Author(s):  
Rakhmie Rafie ◽  
Yusmaidi Yusmaidi ◽  
Mira Fitriyani
Keyword(s):  
Informed Consent ◽  
Confidence Interval ◽  
P Value ◽  
Chi Square ◽  
Cross Sectional

Berdasarkan Permenkes 585/1989 dikatakan bahwa informed consent adalah persetujuan yang diberikan oleh pasien atau keluarganya atas dasar penjelasan mengenai tindakan medis yang akan dilakukan terhadap pasien tersebut. Peran dan tanggung jawab dokter terhadap pelaksanaan tindakan medis berdasarkan imformed consent sangat penting untuk mencegah kemungkinan yang akan terjadi kepada pasien nantinya. Pemahaman terhadap informasi yang diberikan dipengaruhi oleh beberapa faktor, diantaranya karakteristik orang tersebut. Survey analitik dengan desain cross sectional dengan wawancara terpimpin menggunakan kuesioner terhadap 100 responden, dan diolah menggunakan analisa univariat dan bivariat dengan uji Chi-Square. Hasil penelitian menunjukkan bahwa: yang berusia dewasa 84 responden (84%) dan yang berusia muda sebanyak 16 responden (16%), laki- laki 63 responden (63%) dan perempuan 37 responden (37%), yang berpendidikan rendah 41 responden (41%) dan yang berpendidikan tinggi 59 responden, yang tidak bekerja 24 responden (24%) sedangkan yang bekerja 76 responden (76%), yang mempunyai pemahaman baik 58 responden (58%) dan yang tidak baik sebanyak 42 responden (42%). Variabel yang terdapat hubungan bermakna dengan pemahaman terhadap persetujuan tindakan medis pada tindakan bedah di RSPBA pada bulan Maret 2015 adalah umur (nilai p value = 0,037) OR = 3.761 dengan nilai Confidence Interval (1.195-11.835)dan pendidikan (nilai p value = 0,00) OR = 8.551 dengan Confidence Interval (3.436-21.285). Sedangkan variabel yang tidak terdapat hubungan bermakna dengan pemahaman persetujuan tindakan medispada tindakan bedah di RSPBA pada bulan Maret 2015 adalah jenis kelamin (nilai p value = 0,987) dan pekerjaan (p value = 0,251). Terdapat hubungan bermakna antara umur dan pendidikan dengan pemahaman terhadap persetujuan tindakan medis pada tindakan bedah di RS Pertamina Bintang Aamin (RSPBA) pada bulan Maret 2015.  

scholarly journals Development, piloting, and evaluation of an evidence-based informed consent form for total knee arthroplasty (EvAb-Pilot): a protocol for a mixed methods study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Alina Weise ◽  
Julia Lühnen ◽  
Stefanie Bühn ◽  
Felicia Steffen ◽  
Sandro Zacher ◽  
...  
Keyword(s):  
Total Knee Arthroplasty ◽  
Informed Consent ◽  
Adverse Events ◽  
Knee Arthroplasty ◽  
Evidence Based ◽  
Nocebo Effect ◽  
Legal Requirements ◽  
Consent Forms ◽  
Link Type ◽  
Total Knee

Abstract Background Practitioners frequently use informed consent forms to support the physician-patient communication and the informed consent process. Informed consent for surgery often focuses on risk centered information due to high liability risks for treatment errors. This may affect patients’ anxiety of adverse events and the nocebo effect. This study focuses on the optimization of pre-surgical information on risks and complications, and at the same time reconciles these information with legal requirements. Methods The development, piloting, and evaluation of evidence-based informed consent forms for total knee arthroplasty (TKA) and related anesthesia procedures will follow the UK MRC Framework for developing and evaluating complex interventions. Conducting different sub-studies, we will (I) qualitatively explore the information acquisition and decision-making processes, (II) develop and pilot test evidence-based informed consent forms on the example of TKA and related anesthesia procedures, (III) conduct a monocentric interrupted time series (ITS) pilot study to evaluate the effects of evidence-based informed consent forms in comparison with standard consent forms, and (IV) perform a process evaluation to identify barriers and facilitators to the implementation of the intervention and to analyze mechanisms of impact. Discussion The evidence-based and understandable presentation of risks in informed consent forms aims at avoiding distorted risk depiction and strengthening the patients’ competencies to correctly assess the risks of undergoing surgery. This might reduce negative expectations and anxiety of adverse events, which in turn might reduce the nocebo effect. At the same time, the practitioners’ acceptance of evidence-based informed consent forms meeting legal requirements could be increased. Trial registration ClinicalTrials.gov, NCT04669483. Registered 15 December 2020. German Clinical Trials Registry, DRKS00022571. Registered 15 December 2020

scholarly journals Side effects of the metacognitive training for depression compared to a cognitive remediation training in patients with depression

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Mona Dietrichkeit ◽  
Marion Hagemann-Goebel ◽  
Yvonne Nestoriuc ◽  
Steffen Moritz ◽  
Lena Jelinek
Keyword(s):  
Side Effects ◽  
Side Effect ◽  
Statistical Power ◽  
Controlled Trial ◽  
Treatment Options ◽  
Cognitive Remediation ◽  
Negative Effects ◽  
Metacognitive Training ◽  
To Receive

AbstractAlthough awareness of side effects over the course of psychotherapy is growing, side effects are still not always reported. The purpose of the present study was to examine side effects in a randomized controlled trial comparing Metacognitive Training for Depression (D-MCT) and a cognitive remediation training in patients with depression. 84 patients were randomized to receive either D-MCT or cognitive remediation training (MyBrainTraining) for 8 weeks. Side effects were assessed after the completion of each intervention (post) using the Short Inventory of the Assessment of Negative Effects (SIAN) and again 6 months later (follow-up) using the Negative Effects Questionnaire (NEQ). D-MCT and MyBrainTraining did not differ significantly in the number of side effects. At post assessment, 50% of the D-MCT group and 59% of the MyBrainTraining group reported at least one side effect in the SIAN. The most frequently reported side effect was disappointment in subjective benefit of study treatment. At follow-up, 52% reported at least one side effect related to MyBrainTraining, while 34% reported at least one side effect related to the D-MCT in the NEQ. The most frequently reported side effects fell into the categories of “symptoms” and “quality”. Our NEQ version was missing one item due to a technical error. Also, allegiance effects should be considered. The sample size resulted in low statistical power. The relatively tolerable number of side effects suggests D-MCT and MyBrainTraining are safe and well-received treatment options for people with depression. Future studies should also measure negative effects to corroborate our results.

scholarly journals Efficacy and Tolerability of Methotrexate and Methylprednisolone in a Comparative Assessment of the Primary and Long-Term Outcomes in Patients with Pulmonary Sarcoidosis

Diagnostics ◽  
2021 ◽  
Vol 11 (7) ◽  
pp. 1289
Author(s):  
Volodymyr Gavrysyuk ◽  
Ievgenia Merenkova ◽  
Yaroslav Dziublyk ◽  
Nataliia Morska ◽  
Nataliia Pendalchuk ◽  
...  
Keyword(s):  
Side Effects ◽  
Relapse Rate ◽  
Total Duration ◽  
Treatment Resistance ◽  
Pulmonary Sarcoidosis ◽  
Long Term Outcomes ◽  
High Resolution Computed Tomography ◽  
Chi Square ◽  
Ct Data

Background: There is insufficient information in the literature on the comparative efficacy and tolerability of methotrexate (MTX) and methylprednisolone (MP) in patients with pulmonary sarcoidosis in assessing primary outcomes and the relapse rate. Purpose: The aim of our study was to evaluate primary and long-term outcomes of using MTX and MP in patients with pulmonary sarcoidosis. Methods: A total of 143 patients with newly diagnosed pulmonary sarcoidosis, verified by high-resolution computed tomography (CT) data, were examined. Corticosteroid (CS) therapy was used in 97 patients using MP at a dose of 0.4 mg/kg body weight for 4 weeks, followed by a dose reduction to 0.1 mg/kg by the end of the sixth month. The total duration of CS therapy was 12 months on average. Forty-six patients were treated with MTX at a dose of 10 mg/week (28) and 15 mg/week (18) per os for 6 to 12 months. The study of the relapse rate was conducted within 12 months after the CT data normalization in 60 patients after CS therapy and in 24 after MTX treatment. Results: MP treatment was successfully completed in 68 (70.1%), and MTX in 29 (60.4%) patients. In five MP patients (5.2%) and in five (10.9%) MTX, treatment was discontinued due to serious side effects. In seven (7.2%) MP patients and ten (21.7%) MTX patients, treatment required additional therapy due to the lack of efficacy. Progression with MP treatment (17–17.5%) was more common than with MTX (2–4.3%; Chi square = 4.703, p = 0.031). Relapses after MP therapy were observed in 26 (43.3%) patients, and after MTX therapy in 2 (8.3%; Chi square = 9.450, p = 0.003). Conclusion: In patients with pulmonary sarcoidosis, MTX monotherapy does not differ significantly from MP monotherapy in terms of the level of efficacy and the rate of serious side effects. Increasing the MTX dose from 10 to 15 mg/week accelerates the rate of regression of sarcoidosis, improves treatment efficacy, and does not affect the rate of serious side effects. When using MTX, there is a significant decrease in the incidence of treatment resistance and the relapse rate.

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