Therapeutic misunderstandings in modern research.

Clinical trials play a crucial role in generating evidence about healthcare interventions and improving outcomes for current and future patients. For individual trial participants, however, there are inevitably trade-offs involved in clinical trial participation, given that trials have traditionally been designed to benefit future patient populations rather than to offer personalised care. Failure to understand the distinction between research and clinical care and the likelihood of benefit from participation in clinical trials has been termed the 'therapeutic misconception'. The evolution of the clinical trials landscape, including greater integration of clinical trials into healthcare and development of novel trial methodologies, may reinforce the significance of the therapeutic misconception and other forms of misunderstanding while at the same time (paradoxically) challenging its salience. Using cancer clinical trials as an exemplar, we describe how methodological changes in early- and late-phase clinical trial designs, as well as changes in the design and delivery of healthcare, impact upon the therapeutic misconception. We suggest that this provides an impetus to re-examine the ethics of clinical research, particularly in relation to trial access, participant selection, communication and consent, and role delineation.

Perceptions about and reasons for participation in research bronchoscopy in Uganda: A qualitative analysis.

This study sought to assess perceptions towards and reasons for participation in research bronchoscopy studies in a high TB burden urban setting. Additionally, the study aimed to identify areas of pre- and post-procedural concern among healthy adults approached to participate in research bronchoscopy. A cross sectional qualitative study was undertaken at the Uganda-Case Western Reserve University Collaboration Tuberculosis Research Project Clinic at Mulago National Referral Hospital in Kampala, Uganda. In-depth interviews were conducted with participants at their pre-bronchoscopy visit (n = 17) and after they had undergone bronchoscopy (n = 23) to examine their perceptions and experiences with the procedure. Following consent, all interviews were audio recorded and later transcribed and typed in MS WORD. Local language interviews were translated into English by the social science interviewers. Qualitative analysis was performed manually following an inductive and emergent approach typical in thematic analysis. This study was approved by the Makerere University School of Social Sciences Research Ethics Committee (MAKSS REC 09.18.220) and registered with the Uganda National Council for Science and Technology (UNCST SS4785). Overall willingness to participate in bronchoscopy was high as many participants viewed the study as primarily a means of getting free health checks and determining their health status. Notably, despite extensive face to face counseling for this study coupled with the fact that our participants had been involved in prior research at the site, therapeutic misconception still played a pivotal role in willingness to participate in research bronchoscopy. Therapeutic misconception has important ethical and research implications in clinical research, which requires strategies to tackle it, even among a pool of potential participants who are knowledgeable about a disease or clinical care procedures. Continuous awareness and knowledge building about the difference between being a trial participant and therapeutic misconception must become a mainstay in trials to improve the process of informed consent for future research bronchoscopy studies.

A surprising finding: The curious case of a tongue lesion misdiagnosed as paracoccidioidomycosis / Un hallazgo inesperado: el curioso caso de una lesión en la lengua diagnosticada erróneamente como paracoccidioidomicosis

Background: Paracoccidioidomycosis is an endemic mycosis caused by members of the Paracoccidioides genus. Brazil remains the focus area and, to a lesser extent, the disease has been reported from Argentina, Colombia and Venezuela. Aims: A Venezuelan Paracoccidioides brasiliensis strain, isolated from a patient diagnosed with chronic multifocal paracoccidioidomycosis, was subjected to whole genome sequencing to provide more insight about Paracoccidioides outside the endemic focus area. Methods: P. brasiliensis strain CBS 118890 was whole genome sequenced using nanopore; library preparation with the ‘native barcoding genomic DNA kit’ was followed by sequencing on Flongle and MinION flowcells. Batches of strain CBS 118890 were re-identified by sequencing the internal transcribed spacer (ITS) region, and final identification was made based on phylogenetic analysis. Results: Surprisingly, the Venezuelan P. brasiliensis strain CBS 118890 turned out to be a Nannizziopsis species. The batches of this strain were ITS sequenced followed by phylogenetic analysis and resulted in the final identification of Nannizziopsis arthrosporioides. Conclusions: Nannizziopsis infections are commonly seen in a wide variety of reptiles, but are particularly rare in human infections. This case underlines the need for molecular characterization of cases that clinically mimic paracoccidioidomycosis but that are serologically negative for Paracoccidioides.(AU)

Antecedentes: La paracoccidioidomicosis es una micosis endémica causada por especies del género Paracoccidioides. Brasil sigue siendo el área con la mayor incidencia y, en menor medida, se ha informado de casos en Argentina, Colombia y Venezuela. Objetivos: Una cepa venezolana de Paracoccidioidesbrasiliensis, obtenida de un paciente diagnosticado con paracoccidioidomicosis multifocal crónica, se sometió a secuenciación completa del genoma para obtener más información sobre Paracoccidioides fuera del área de foco endémico. Métodos: Se secuenció el genoma completo de la cepa CBS 118890 de P. brasiliensis mediante la técnica de secuenciación de nanoporos; tras la preparación de la librería con el «native barcoding genomic DNA kit» se procedió a la secuenciación con el Flongle y MinION flowcells. Los lotes de la cepa CBS 118890 se volvieron a identificar mediante la secuenciación de la región del espaciador transcrito interno (ITS), y la identificación final se realizó en función del análisis filogenético. Resultados: Sorprendentemente, la cepa venezolana P. brasiliensis CBS 118890 resultó ser una especie de Nannizziopsis. Los lotes de esta cepa se secuenciaron mediante ITS seguido de un análisis filogenético y dieron como resultado la identificación de la especie Nannizziopsis arthrosporioides. Conclusiones: Las infecciones por Nannizziopsis se observan comúnmente en una amplia variedad de reptiles, pero son particularmente raras en infecciones humanas. Este caso subraya la necesidad de la caracterización molecular de los casos que clínicamente reflejan paracoccidioidomicosis, pero que son serológicamente negativos para Paracoccidioides.(AU)

When research becomes practice: the concept of the therapeutic misconception and challenges to consent in clinical trials.

Many factors influence patients' decisions to participate in clinical trials. For many, the primary motivation is the possibility that they might derive some benefit from participation. This is particularly true for patients with limited treatment options, such as patients with advanced cancer. While this is not surprising, it is potentially problematic if patients fail to recognise the distinction between research and clinical care (a phenomenon known as the 'therapeutic misconception'). This is becoming increasingly problematic as clinical trial designs become more complex, as clinical trials become more embedded in routine clinical care, and as trials are increasingly used by patients and clinicians to access new diagnostic platforms and therapies. We outline some of these recent trends, focusing on the cancer clinical trials landscape as this provides a good case study of the phenomenon. We conclude by making preliminary suggestions that changes to the consent process, perhaps using 'dynamic consent' platforms, might help to mitigate the therapeutic misconception and note the need for further research to guide strategies for improving communication and decision-making.

Therapeutic Misestimation in Patients with Degenerative Ataxia: Lessons from a Randomized Controlled Trial.

BACKGROUND: The absence of effective treatments may render patients with degenerative cerebellar ataxias susceptible to a placebo response, which could affect the outcome of clinical trials. OBJECTIVE: To retrospectively examine expectations of benefit in participants of an ataxia trial and identify determinants of possible therapeutic misestimation. METHODS: Individuals with spinocerebellar ataxia type 3 who participated in a randomized, double-blind, sham-controlled trial received a custom-designed questionnaire about short-term and long-term treatment expectations, allocation preferences, and interpretation of treatment arm assignment based on the presence or absence of clinical improvement. To evaluate whether expectations were specifically related to the application of cerebellar transcranial direct current stimulation (tDCS) or more generally reflect an overly positive attitude of patients with ataxia toward trial participation and results, the last questions involved a hypothetical scenario in which an oral drug was tested against placebo with an aim identical to that of our tDCS study. RESULTS: All 20 trial participants completed the questionnaire. If allocated to the active treatment arm, 75% of patients expected short-term health benefits and 55% thought they would still have less severe ataxia at 1-year follow-up compared with baseline. After 2 weeks, an average reduction in ataxia severity of 31.5% (standard deviation, 22.2%) was anticipated. Conversely, 65% associated a lack of improvement with probable or definite allocation to the placebo group. High expectations of benefit were neither related to the type of intervention nor to clinical or demographic characteristics. CONCLUSION: Therapeutic misestimation is common in patients with degenerative ataxia and requires special attention in future trials. © 2022 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

Four reasons why too many informed consents to clinical research are invalid: a critical analysis of current practices.

OBJECTIVE: Informed consent (IC) is a central ethical and legal requirement for clinical research that aims to protect the autonomy of participants. To enable an autonomous decision and valid consent, adequate understanding must be ensured. However, a considerable proportion of participants do not understand the relevant aspects about participation in research, for example, approximately 45% could not name at least one risk. As such, the inadequate understanding of IC has been known for several decades, and it still constitutes a severe problem for the ethical conduct of research. Through delineating the most pressing deficits of current IC procedures that lead to insufficient understanding, we aim to encourage the discussion among stakeholders, for example, clinical researchers, and to provide the grounds for practical solutions. MAIN ARGUMENTS: (1) IC documents are too long to be read completely, thus, make it very difficult for potential participants to identify the material facts about the trial. (2) The low readability of the IC documents disadvantages persons with limited literacy. (3) The therapeutic misconception frequently prevents participants to realise that the primary purpose of clinical research is to benefit future patients. (4) Excessive risk disclosures, insufficient information about expected benefits and framing effects compromise a rational risk/benefit assessment. CONCLUSION: Due to these deficits, practices of IC in clinical research too often preclude adequate understanding of prospective participants, thus, invalidating IC. The gap between the well-specified ethical norm to enable IC and its insufficient translation into practice can no longer be accepted, as participant rights and the public trust in responsible research are at stake. Hence, immediate action is needed to address the prevailing deficits.

Therapeutic Misconception about Research Procedures: Does a Simple Information Chart Improve Understanding?

In phase I trials, some biospecimens are used both for research and patient care and some for research only. Some research participants have therapeutic misconception, assuming all biospecimens are for patient care. This study's aim was to test if a simple information chart would improve understanding of nontherapeutic research procedures. A two-arm study was conducted. Participants in the control group (C) were asked whether biospecimens were for their care, for research only, or for both. The experimental group (E) was asked the same questions but provided with a study-specific information chart labeling the purpose of each biospecimen. One hundred one patients were interviewed. In both arms, understanding that pretreatment blood draws were for patient care and research was moderate (49% for C and 62% for E). Understanding that posttreatment blood draws were for research only was significantly higher in the experimental arm (16% for C and 44% for E; p = 0.002). Providing a simple information chart may help alleviate this aspect of therapeutic misconception.

Knowledge, risk-perception, and uptake of COVID-19 prevention measures in sub-Saharan Africa: a scoping review

Background: The COVID-19 pandemic has almost affected the entire globe and is currently in a resurgent phase within the sub-Saharan African region. Objective: This paper presents results from a scoping review of literature on knowledge, risk-perception, conspiracy theories and uptake of COVID-19 prevention measures in sub-Saharan Africa. Methods: We used the following search terms: 'COVID-19', 'knowledge', 'perceptions', 'perspectives', 'misconceptions', 'conspiracy theories', 'practices' and 'sub-Saharan Africa'. Basing on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews (PRISMA-ScR) guidelines, we identified 466 articles for review; 36 articles met the inclusion criteria. We extracted data on knowledge, risk perception, conspiracy theories and uptake of COVID-19 primary prevention measures. Results: Knowledge of COVID-19 was high (91.3-100%) and associated with age and education; risk-perception was equally high (73.3-86.9%) but varied across studies. Uptake of handwashing with water and soap or hand-sanitizing ranged between 63-96.4%, but wearing of face masks and social distancing fared poorly (face masks: 2.7%-37%; social distancing: 19-43%). Conclusion: While knowledge of COVID-19 is nearly universal, uptake of COVID-19 prevention measures remains sub-optimal to defeat the pandemic. These findings suggest a need for continued health promotion to increase uptake of the recommended COVID-19 prevention measures in sub-Saharan Africa

Barriers to cyotherapy treatment services for precancerous cervical lesions among women in Western Kenya

BACKGROUND Cervical cancer is the fourth most fatal and common disease globally among women of reproductive age in Kenya; it ranks the second most frequent type of cancer after breast cancer. Due to the high burden, cryotherapy treatment services, which are effective for the treatment of precancerous lesions are available in selected health facilities in Kenya, however, barriers to the treatment services are poorly understood. Nonetheless, understanding these barriers is critical for enhanced service delivery. MATERIALS AND METHODS :A descriptive facility-based cross-sectional study design was carried out to determine the barriers to cryotherapy treatment services among 60 women of reproductive age on a one-year therapy at Migosi Sub County Hospital in Western Kenya. The participants were selected purposively and interviewed via telephone calls using pre-coded semi-structured questionnaires. However, data from 5 nurses working in the cryotherapy section were collected through face-to-face interviews at the health facility. Data were entered in an excel sheet and then exported to SPSS version 23.0 for analysis. Both descriptive and inferential statistics (Chi-square) were used and data were presented in form of tables. RESULTS :Overall, 52 (85.4%) respondents adhered to post-care treatment instructions and reported no adverse reactions. However, 28 (46.7%) experienced unavailability of cryotherapy services at the time of the appointment and got the services later, 24 (40%) got the services at the time of the appointment but waited for a long time before being served, 37 (61.7%) did not know why they were being treated and 46 (76.7%) had misconceptions and myths about the therapy. In addition, there was a statistically significant association between knowing both the benefits of screening and cryotherapy [X 2 (1, N = 60) = 5.90, p = .02]. Also, the knowledge of the benefits of cryotherapy did not influence one's decision to wait for cryotherapy treatment services, [X 2(1, N = 60) = 3.98, p = .46]. CONCLUSION : The study shows very good adherence to post-treatment instruction but inadequate availability of cryotherapy treatment services. Also, the misconceptions and myths about cryotherapy are public health concerns. Therefore, the study recommends improved awareness campaigns and service delivery for the enhanced uptake of cryotherapy treatment services.

Misconceptions and associated factors of COVID-19 infection among internally displaced persons in Sudan

Coronavirus disease 2019 (COVID-19) is a global public health threat that has spread rapidly and caused morbidity and mortality worldwide. Reducing the myths about infectious diseases is vital for controlling transmission. This study explored the level of misconceptions and associated factors of COVID-19 among internally displaced persons in Sudan. This study is a cross-sectional, descriptive design and community-based study. We collected the data using a self-administered questionnaire via the convenience sampling technique among internally displaced persons in the camps of Zalingei town in the central Darfur region of Sudan. The total mean score of the respondents' misconception was 3.1725 (SD=0.59) with 63.2%, indicating moderate misunderstanding of COVID-19. Multiple linear regression revealed the independent variables together had a significant impact on a misconception, F(14,116)=2.429, p<0.005. The regression model explains 22.7% of the variance in misunderstanding. Analysis of the influence of single factors on the dependent variable showed that people aged 31­40 years had significantly higher levels of misconception, 0.381 (t=2.116, p<0.037), than those aged over 60 years, and university graduates had considerably lower levels of misunderstanding, −0.061 (t=−2.091, p<0.03) than non-graduates. This study found a moderate level of misconception of COVID-19. Non-graduates had higher levels of misunderstanding than graduates. The results suggest that an education campaign should focus on people with low levels of education to correct their misconceptions regarding the prevention of COVID-19 infection

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.

Reassessing the measurement and presence of therapeutic misconception in a phase 1 setting.

BACKGROUND: Therapeutic misconception (TM) refers to research subjects' failure to distinguish the goals of clinical research from standard personal care. TM has traditionally been determined by questioning the patient about the research study's purpose. Recent research, however, has questioned whether TM is as prevalent as reported due to discrepancies between patient/researcher interpretations of TM questions. The authors have created an interview tool receptive to these advancements to more accurately determine the prevalence of TM. METHODS: Patients were questioned about the trial's purpose as follows: 1) "Is the trial mostly intending to help research and gain knowledge?," 2) "Is it mostly intending to help you as a person?," or 3) "Don't know." Participants were then asked what they thought this question was asking: A) "What my own intentions are for participating," B) "What the official purpose of the research study is," or C) "Not sure." A patient exhibited TM by answering that the official trial purpose was to help him or her. RESULTS: Patients (n = 98) had a mean age of 60 years, were mostly White (64%), had a combined family annual income ≥$60,000 (61%), and 49% had a college degree. Twelve of 98 patients (12%) definitely exhibited TM. This was much lower than the author's original finding of 68% in a similar cohort. Twenty-four of 98 patients (24.5%) were unclear about what one or both questions were asking and could not be categorized. CONCLUSIONS: Previously, a patient was thought to have TM if they answered that the purpose of the trial was to benefit to him or her. An additional query about how patients interpreted that question revealed only 12% definitely had TM. LAY SUMMARY: Therapeutic misconception (TM) refers to research subjects' failure to distinguish the goals of clinical research from standard personal care. TM signals a basic misunderstanding of the purpose of clinical research, threatening valid informed consent to participate in clinical trials. TM has traditionally been determined by questioning patients about their research study's purpose. Recent research, however, has questioned whether TM is as prevalent due to discrepancies between patient/researcher interpretations of TM questions. By developing an interview-tool receptive to these advancements, we report a lower TM estimate in the phase 1 setting (12%) than we found previously in a similar cohort (68%).

Professional integrity in maternal - fetal innovation and research: an essential component of perinatal medicine.

OBJECTIVES: Clinical innovation and research on maternal-fetal interventions have become an essential for the development of perinatal medicine. In this paper, we present an ethical argument that the professional virtue of integrity should guide perinatal investigators. METHODS: We present an historical account of the professional virtue of integrity and the key distinction that this account requires between intellectual integrity and moral integrity. RESULTS: We identify implications of both intellectual and moral integrity for innovation, research, prospective oversight, the role of equipoise in randomized clinical trials, and organizational leadership to ensure that perinatal innovation and research are conducted with professional integrity. CONCLUSIONS: Perinatal investigators and those charged with prospective oversight should be guided by the professional virtue of integrity. Leaders in perinatal medicine should create and sustain an organizational culture of professional integrity in fetal centers, where perinatal innovation and research should be conducted.

Diez errores estadísticos frecuentes que tener en cuenta al escribir o revisar un artículo / Ten common statistical mistakes to watch out for when writing or reviewing a manuscript

Inspirados por esfuerzos más amplios para hacer más sólidas las conclusiones de la investigación científica, hemos recopilado una lista de algunos de los errores estadísticos más comunes que aparecen en la literatura científica. Los errores tienen su origen en diseños experimentales ineficaces, análisis inapropiados y/o razonamientos erróneos. Proporcionamos asesoramiento sobre la forma en que los autores, revisores y lectores pueden identificar y resolver estos errores y esperamos evitarlos en el futuro. Todos los errores pueden ser identificados en los distintos apartados de una publicación principalmente en material y métodos, resultados o conclusiones

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Talk to Patients About: Vaccines and SIDS.

Over the years, several vaccines have been blamed for SIDS, including those for pertussis, tetanus, diphtheria, Hemophilus influenzae type B, polio, and hepatitis B. This misconception has triggered a lot of scientific study to find out if vaccines could, in fact, cause SIDS. However, multiple studies and safety reviews have concluded that the answer is no, according to the Centers for Disease Control and Prevention (CDC).