Setting the Terms for Zoonotic Diseases: Effective Communication for Research, Conservation, and Public Policy.

Many of the world's most pressing issues, such as the emergence of zoonotic diseases, can only be addressed through interdisciplinary research. However, the findings of interdisciplinary research are susceptible to miscommunication among both professional and non-professional audiences due to differences in training, language, experience, and understanding. Such miscommunication contributes to the misunderstanding of key concepts or processes and hinders the development of effective research agendas and public policy. These misunderstandings can also provoke unnecessary fear in the public and have devastating effects for wildlife conservation. For example, inaccurate communication and subsequent misunderstanding of the potential associations between certain bats and zoonoses has led to persecution of diverse bats worldwide and even government calls to cull them. Here, we identify four types of miscommunication driven by the use of terminology regarding bats and the emergence of zoonotic diseases that we have categorized based on their root causes: (1) incorrect or overly broad use of terms; (2) terms that have unstable usage within a discipline, or different usages among disciplines; (3) terms that are used correctly but spark incorrect inferences about biological processes or significance in the audience; (4) incorrect inference drawn from the evidence presented. We illustrate each type of miscommunication with commonly misused or misinterpreted terms, providing a definition, caveats and common misconceptions, and suggest alternatives as appropriate. While we focus on terms specific to bats and disease ecology, we present a more general framework for addressing miscommunication that can be applied to other topics and disciplines to facilitate more effective research, problem-solving, and public policy.

Focus group discussions on low-flow oxygen and bubble CPAP treatments among mothers of young children in Malawi: a CPAP IMPACT substudy.

OBJECTIVE: To determine the acceptability of bubble continuous positive airway pressure (bCPAP) and low-flow oxygen among mothers of children who had received either therapy. SETTING: A district hospital in Salima, Malawi. PARTICIPANTS: We conducted eight focus group discussions (FGDs) with a total of 54 participants. Eligible participants were mothers of children 1 to 59 months of age with severe pneumonia and a comorbidity (HIV-infection, HIV-exposure, malnutrition or hypoxaemia) who, with informed consent, had been enrolled in a randomised clinical trial, CPAP IMPACT (Improving Mortality for Pneumonia in African Children Trial), comparing low-flow oxygen and bCPAP treatments (ClinicalTrials.gov, NCT02484183). PRIMARY AND SECONDARY OUTCOME MEASURES: FGDs assessed mothers' attitudes and feelings towards oxygen and bCPAP before and after therapy along with general community perceptions of respiratory therapies. Data was analysed using inductive thematic analysis to assess themes and subthemes of the transcripts. RESULTS: Community perceptions of oxygen and bCPAP were widely negative. Mothers recounted that they are told that 'oxygen kills babies'. They are often fearful of allowing their child to receive oxygen therapy and will delay treatment or seek alternative therapies. Mothers report limiting oxygen and bCPAP by intermittently removing the nasal cannulas or mask. After oxygen or bCPAP treatment, regardless of patient outcome, mothers were supportive of the treatment their child received and would recommend it to other mothers. CONCLUSION: There are significant community misconceptions around oxygen and bCPAP causing mothers to be fearful of either treatment. In order for low-flow oxygen treatment and bCPAP implementation to be effective, widespread community education is necessary.

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.

Informed Consent, Therapeutic Misconception, and Unrealistic Optimism.

The Belmont Report attested to the cardinal importance of informed consent for ethical research on human subjects. Important challenges to securing informed consent have emerged since its publication more than 40 years ago. Among some of the most significant of these challenges are those that highlight social psychological factors that have the potential to impair the appreciation of relevant information disclosed in the informed consent process. Responding to these challenges requires us to think harder about the content of the principle of informed consent and the demands that it imposes on investigators. This article focuses on two challenges in particular, that presented by the so-called therapeutic misconception, and that presented by the psychological bias of unrealistic optimism. After outlining an account of the principle of informed consent as it applies to the research context, the article briefly reviews the empirical literature on the therapeutic misconception and the bias of unrealistic optimism. It then relates these phenomena to the principle of informed consent, paying special attention to the ethical demands they impose on investigators. The article concludes by considering how recent trends to integrate research and clinical care affect the main points it has advanced.

Misconceptions and the Acceptance of Evidence-based Nonsurgical Interventions for Knee Osteoarthritis. A Qualitative Study.

BACKGROUND: In contrast to best practice guidelines for knee osteoarthritis (OA), findings from several different healthcare settings have identified that nonsurgical treatments are underused and TKA is overused. Empirical evidence and qualitative observations suggest that patients' willingness to accept nonsurgical interventions for knee OA is low. A qualitative investigation of why patients may feel that such interventions are of little value may be an important step toward increasing their use in the treatment of knee OA QUESTIONS/PURPOSES: This qualitative study was embedded in a larger study investigating patient-related factors (beliefs/attitudes toward knee OA and its treatment) and health-system related factors (access, referral pathways) known to influence patients' decisions to seek medical care. In this paper we focus on the patient-related factors with the aim of exploring why patients may feel that nonsurgical interventions are of little value in the treatment of knee OA. METHODS: A cross-sectional qualitative study was conducted in a single tertiary hospital in Australia. Patients with endstage knee OA on the waiting list for TKA were approached during their preadmission appointment and invited to participate in one-to-one interviews. As prescribed by the qualitative approach, data collection and data analysis were performed in parallel and recruitment continued until the authors agreed that the themes identified would not change through interviews with subsequent participants, at which point, recruitment stopped. Thirty-seven patients were approached and 27 participated. Participants were 48% female; mean age was 67 years. Participants' beliefs about knee OA and its treatment were identified in the interview transcripts. Beliefs were grouped into five belief dimensions: identity beliefs (what knee OA is), causal beliefs (what causes knee OA), consequence beliefs (what the consequences of knee OA are), timeline beliefs (how long knee OA lasts) and treatment beliefs (how knee OA can be controlled). RESULTS: All participants believed that their knee OA was "bone on bone" (identity beliefs) and most (> 14 participants) believed it was caused by "wear and tear" (causal beliefs). Most (> 14 participants) believed that loading the knee could further damage their "vulnerable" joint (consequence beliefs) and all believed that their pain would deteriorate over time (timeline beliefs). Many (>20 participants) believed that physiotherapy and exercise interventions would increase pain and could not replace lost knee cartilage. They preferred experimental and surgical treatments which they believed would replace lost cartilage and cure their knee pain (treatment beliefs). CONCLUSIONS: Common misconceptions about knee OA appear to influence patients' acceptance of nonsurgical, evidence-based treatments such as exercise and weight loss. Once the participants in this study had been "diagnosed" with "bone-on-bone" changes, many disregarded exercise-based interventions which they believed would damage their joint, in favor of alternative and experimental treatments, which they believed would regenerate lost knee cartilage. Future research involving larger, more representative samples are needed to understand how widespread these beliefs are and if/how they influence treatment decisions. In the meantime, clinicians seeking to encourage acceptance of nonsurgical interventions may consider exploring and targeting misconceptions that patients hold about the identity, causes, consequences, timeline, and treatment of knee OA. LEVEL OF EVIDENCE: Level II, prognostic study.

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.

Información sobre la quimioterapia paliativa en pacientes con cáncer avanzado: una revisión / Information on palliative chemotherapy in patients with advanced cancer: a review

Introducción. La quimioterapia paliativa es el tratamiento específico de primera elección en la mayoría de los pacientes oncológicos con enfermedad avanzada y es esencial que los pacientes entiendan los objetivos del tratamiento y las expectativas se ajusten al proceso de la enfermedad. Objetivo: Hacer una revisión sistemática sobre las creencias y expectativas que tienen los pacientes que reciben quimioterapia paliativa. Método. Se realizaron búsquedas en PubMed desde el año 2000 hasta la actualidad. Artículos escritos en inglés y español. Un total de 20 artículos cumplieron los criterios de inclusión. Resultados: Alrededor de la mitad de los pacientes que reciben quimioterapia paliativa, tienen creencias erróneas sobre las expectativas y objetivos del tratamiento. Los pacientes que entienden los objetivos del tratamiento presentan menor probabilidad de recibir quimioterapia al final de la vida, menores síntomas de ansiedad y depresión, mayor sensación de control y deseo de cuidados paliativos que se asocian a mejor calidad de vida. Conclusión: un porcentaje significativo de pacientes oncológicos en fase avanzada, reciben quimioterapia paliativa sin conocer el objetivo del tratamiento con expectativas erróneas de curarse, lo que dificulta la participación en la toma de decisiones sobre su plan de cuidados

Introduction: Palliative chemotherapy is the first-line specific treatment in most oncology patients with advanced disease and it is essential for patients to understand the goals of treatment and expectations to fit the disease process. Objective: To systematically review the beliefs and expectations of patients receiving palliative chemotherapy about treatment. Method: We searched PubMed from 2000 to the present. Articles written in English and Spanish. A total of 20 articles met the inclusion criteria. Results: About half of patients receiving palliative chemotherapy have misconceptions about treatment expectations and goals. Patients who understand the goals of treatment are less likely to receive chemotherapy at the end of life, less anxiety and depression, greater sense of control and desire for palliative care associated with better quality of life

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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.

Vulnerability, therapeutic misconception and informed consent: is there a need for special treatment of pregnant women in fetus-regarding clinical trials?

Historically, pregnant women have generally been excluded from clinical trials. One of the reasons for this exclusion has been the belief that pregnant women are vulnerable as research participants. Although this view has now largely fallen into disfavour, this article argues that in the situation where the pregnant woman is newly diagnosed with a fetal condition for which the only option, other than watchful waiting, is enrolment in a clinical trial, she should be considered a cognitively and medically vulnerable research participant. This is because she is in a highly stressed emotional state and so less able to decide completely freely whether or not to participate in the clinical trial. In other words, she is under a higher risk of therapeutic misconception and of not understanding what she is consenting to. This article suggests that in order for the consent of these women to be given freely and without emotional pressure, it has to be ensured that strategies are developed to ensure they are fully informed and actually understand the information. This surpasses the requirements of the English law of informed consent and also of General Medical Council (GMC) guidance on consent to research but such an approach would help safeguard that, despite these women's poor bargaining position, their trial participation is really free, voluntary and informed.

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.