Patient Perceptions in a Nonblinded Randomized Trial of Radiation Therapy Technologies: A Novel Survey Study Exploring Therapeutic Misconception.

PURPOSE: Therapeutic misconception is the tendency for a clinical trial participant to overlook the scientific objective of a clinical trial and instead believe that an experimental intervention is intended for personal therapeutic benefit. We sought to evaluate this tendency in the setting of a clinical trial of a new radiation therapy technology. METHODS: Patients with left-sided, node positive breast cancer enrolled in a randomized clinical trial evaluating intensity modulated radiation therapy with deep inspiration breath hold (IMRT-DIBH) versus 3-dimensional conformal radiation therapy (3DCRT). Patients who enrolled completed surveys at baseline, after randomization, and upon completion of radiation therapy to evaluate expectations, satisfaction, and experiences. RESULTS: Forty women participated in the survey study, with 20 in each arm. Most participants endorsed the perception that participation in the trial might result in better treatment than the current standard treatment (77%) and more medical attention than being off trial (54%). At baseline, most women (74%) believed that a new treatment technology is superior than an established one. Before randomization, 43% of participants believed IMRT-DIBH would be more effective than standard treatment with 3DCRT, none believed that 3DCRT would be more effective, 23% believed that they would be the same, and 34% did not know. None believed that IMRT-DIBH would cause worse long-term side effects, whereas 37% thought that 3DCRT would. Most (71%) reported that they would choose to be treated with IMRT-DIBH; none would have elected 3DCRT if given a choice. Nearly half (44%) in the 3DCRT arm wished that they had been assigned to the IMRT-DIBH arm; none in the IMRT-DIBH arm expressed a wish for crossover. CONCLUSIONS: Most participants reported the perception that trial participation would result in better treatment and more medical attention than off trial, hallmarks of therapeutic misconception. Our observations provide empirical evidence of a fixed belief in the superiority of new technology and highlight the importance of adjusting expectations through informed consent to mitigate therapeutic misconception.

Use of complementary/integrative methods: cancer survivors' misconceptions about recurrence prevention.

PURPOSE: Many cancer survivors use complementary and alternative health methods (CAM). Because we are unaware of high-level evidence supporting CAM for preventing cancer recurrence, we studied post-treatment survivors who use CAM to assess (1) the percentage who included preventing recurrence as a motive for using CAM, (2) characteristics of survivors who use CAM intended to prevent recurrence, and (3) CAM domains associated with use for recurrence prevention. METHODS: We studied participants in the American Cancer Society's Study of Cancer Survivors-I (nationwide study of adult survivors) who used CAM (excluding osteopathy, yoga, tai chi, or qi gong users, as well as anyone whose only reported CAM was prayer/meditation). Multivariable logistic regression was used to examine associations of independent variables with CAM use for recurrence prevention. RESULTS: Among 1220 survivors using CAM, 14.8% reported recurrence prevention as a reason for CAM use (although only 0.4% indicated this was their only reason). The following were independently associated with odds of CAM use to prevent recurrence: not being married/in a marriage-like relationship (OR = 1.53, 95% confidence interval [CI] 1.05-2.23), using mind-body (OR = 1.65, 95% CI 1.08-2.51) or biologically based (OR = 4.11, 95% CI 1.96-8.59) CAM and clinically relevant fear of recurrence (OR = 1.96, 95% CI 1.38-2.78). CONCLUSIONS: Approximately 1/7 of survivors who use CAM have unrealistic expectations about CAM reducing recurrence risk. This expectation is strongly associated with the use of biologically based CAM. IMPLICATIONS FOR CANCER SURVIVORS: Patient education should support informed decisions and realistic expectations regarding any complementary/integrative or mainstream/conventional clinical intervention.

Video or verbal? A randomised trial of the informed consent process prior to endoscopy.

AIM: Informed consent (IC) prior to endoscopy is often inconsistently and poorly performed. We compared use of video-assisted consent to standard verbal consent for enhancing patients' recollection of procedural risks, understanding and fulfilment of expectation. METHOD: Two hundred patients attending for gastroscopy or colonoscopy were randomised to either video-assisted consent (n=100) or verbal consent (n=100). The primary outcomes measured via a questionnaire were the recollection of procedural risks (sum of all correct answers for risk recall items) and patient experience compared to information provided in the consent process. Secondary outcomes included reported patient understanding and staff satisfaction between groups. RESULTS: There was no difference between video or verbal groups in terms of risk recall scores (p=0.46), with less than half the patients able to recall more than two risks. There was a signal towards improved recall of bleeding as a potential risk in the video as compared to the verbal arm but it did not reach statistical significance (p=0.059). Patients' perceived understanding and fulfilment of expectation was high (>96%) in both groups. Seventy-one percent of the staff preferred using the video over the verbal IC. CONCLUSION: Video-assisted consent made no significant difference to the IC process in terms of patient recollection or experience compared to usual verbal IC. Despite very poor recollection of procedural risks, patients in both the video and verbal groups reported understanding of the procedure and satisfaction with the IC process. Reasons for this mismatch are unclear. Further action to prioritise information delivery during IC is required. Future studies in this field should include patient-centred outcomes as a measure of success.

Reducing therapeutic misconception: A randomized intervention trial in hypothetical clinical trials.

BACKGROUND: Participants in clinical trials frequently fail to appreciate key differences between research and clinical care. This phenomenon, known as therapeutic misconception, undermines informed consent to clinical research, but to date there have been no effective interventions to reduce it and concerns have been expressed that to do so might impede recruitment. We determined whether a scientific reframing intervention reduces therapeutic misconception without significantly reducing willingness to participate in hypothetical clinical trials. METHODS: This prospective randomized trial was conducted from 2015 to 2016 to test the efficacy of an informed consent intervention based on scientific reframing compared to a traditional informed consent procedure (control) in reducing therapeutic misconception among patients considering enrollment in hypothetical clinical trials modeled on real-world studies for one of five disease categories. Patients with diabetes mellitus, hypertension, coronary artery disease, head/neck cancer, breast cancer, and major depression were recruited from medical clinics and a clinical research volunteer database. The primary outcomes were therapeutic misconception, as measured by a validated, ten-item Therapeutic Misconception Scale (range = 10-50), and willingness to participate in the clinical trial. RESULTS: 154 participants completed the study (age range, 23-87 years; 92.3% white, 56.5% female); 74 (48.1%) had been randomized to receive the experimental intervention. Therapeutic misconception was significantly lower (p = 0.004) in the scientific reframing group (26.4, 95% CI [23.7 to 29.1] compared to the control group (30.9, 95% CI [28.4 to 33.5], and remained so after controlling for education (p = 0.017). Willingness to participate in the hypothetical trial was not significantly different (p = 0.603) between intervention (52.1%, 95% CI [40.2% to 62.4%]) and control (56.3%, 95% CI [45.3% to 66.6%] groups. CONCLUSIONS: An enhanced educational intervention augmenting traditional informed consent led to a meaningful reduction in therapeutic misconception without a statistically significant change in willingness to enroll in hypothetical clinical trials. Additional study of this intervention is required in real-world clinical trials.

Why take part in personalised cancer research? Patients' genetic misconception, genetic responsibility and incomprehension of stratification-an empirical-ethical examination.

Therapeutic misconception is a well-known challenge for informed decision-making for cancer research participants. What is still missing, is a detailed understanding of the impact of "personalised" treatment research (e.g. biomarkers for stratification) on research participants. For this, we conducted the first longitudinal empirical-ethical study based on semi-structured interviews with colorectal cancer patients (n = 40) enrolled in a biomarker trial for (neo)adjuvant treatment, analysing the patients' understanding of and perspectives on research and treatment with qualitative methods. In addition to therapeutic misconception based on patients' confusion of research and treatment, and here triggered by misled motivation, information paternalism or incomprehension, we identified genetic misconception and genetic responsibility as new problematic issues. Patients mainly were not aware of the major research aim of future stratification into responders and non-responders nor did they fully acknowledge this as the aim for personalised cancer research. Thus, ethical and practical reflection on informed decision-making in cancer treatment and research should take into account the complexity of lay interpretations of modern personalised medicine. Instead of very formalistic, liability-oriented informed consent procedures, we suggest a more personalised communication approach to inform and motivate patients for cancer research.

Dispositional optimism and therapeutic expectations in early-phase oncology trials.

BACKGROUND: Prior research has identified unrealistic optimism as a bias that might impair informed consent among patient-subjects in early-phase oncology trials. However, optimism is not a unitary construct; it also can be defined as a general disposition, or what is called dispositional optimism. The authors assessed whether dispositional optimism would be related to high expectations for personal therapeutic benefit reported by patient-subjects in these trials but not to the therapeutic misconception. The authors also assessed how dispositional optimism related to unrealistic optimism. METHODS: Patient-subjects completed questionnaires designed to measure expectations for therapeutic benefit, dispositional optimism, unrealistic optimism, and the therapeutic misconception. RESULTS: Dispositional optimism was found to be significantly associated with higher expectations for personal therapeutic benefit (Spearman rank correlation coefficient [r], 0.333; P<.0001), but was not associated with the therapeutic misconception (Spearman r, -0.075; P = .329). Dispositional optimism was found to be weakly associated with unrealistic optimism (Spearman r, 0.215; P = .005). On multivariate analysis, both dispositional optimism (P = .02) and unrealistic optimism (P<.0001) were found to be independently associated with high expectations for personal therapeutic benefit. Unrealistic optimism (P = .0001), but not dispositional optimism, was found to be independently associated with the therapeutic misconception. CONCLUSIONS: High expectations for therapeutic benefit among patient-subjects in early-phase oncology trials should not be assumed to result from misunderstanding of specific information regarding the trials. The data from the current study indicate that these expectations are associated with either a dispositionally positive outlook on life or biased expectations concerning specific aspects of trial participation. Not all manifestations of optimism are the same, and different types of optimism likely have different consequences for informed consent in early-phase oncology research.

Presentation delay in breast cancer patients, identifying the barriers in North Pakistan.

BACKGROUND: There is strong evidence that delayed diagnosis of breast cancer is associated with poor survival. Our objectives were to determine the frequency of breast cancer patients with delayed presentation, the reasons of delay and its association with different socio-demographic variables in our North Pakistan setting. MATERIALS AND METHODS: We interviewed 315 histologically confirmed breast cancer patients. Delay was defined as more than 3 months from appearance of symptoms to consultation with a doctor. Questions were asked from each patient which could reflect their understanding about the disease and which could be the likely reasons for their delayed presentation. RESULTS: 39.0 % (n=123) of patients presented late and out of those, 40.7% wasted time using alternative medicines; 25.2 % did not having enough resources; 17.1 % presented late due to painless lump; 10.6% felt shyness and 6.5% presented late due to other reasons. Higher age, negative family history, < 8 school years of education and low to middle socio-economic status were significantly associated with delayed presentation (p< 0.05). Education and socioeconomic status were two independent variables related to the delayed presentation after adjustment for others (OR of 2.26, 2.29 and 95%CI was 1.25-4.10, 1.06-4.94 respectively). CONCLUSIONS: Significant numbers of women with breast cancer in North Pakistan experience presentation delay due to their misconceptions about the disease. Coordinated efforts with public health departments are needed to educate the focused groups and removing the barriers identified in the study. Long term impact will be reduced overall burden of the disease in the region.

Current controversies in the USA regarding vaccine safety.

As a result of the vaccines discovered in the 20th Century, parents and many healthcare providers of the 21st Century have limited or no experience with the devastating effects of diseases such as polio, smallpox or measles. Fear of disease has shifted to concerns regarding vaccine safety. Scientific evidence has refuted many of the misconceptions regarding vaccine safety; however, parental refusal of vaccines is increasing. Here we review six of the most prevalent controversies surrounding vaccine safety: the proposed causal relationship between receipt of the measles-mumps-rubella vaccine and autism; thimerosal as a potential trigger for autism; religious objection based on some vaccine viruses being grown in cell lines from aborted fetal tissues; parental worries that use of the human papillomavirus vaccine may lead to youth promiscuity; fears regarding the purported association between pertussis vaccination and adverse neurological outcomes; and concerns regarding too many vaccines overloading or weakening the infant immune system. Healthcare providers are ideally positioned to correct these misconceptions, but they must recognize and acknowledge parents' concerns, educate themselves on the latest scientific research that addresses these, and dedicate sufficient time to discuss vaccine safety with worried parents.