Termo de consentimento livre e esclarecido e sua relação com os procedimentos de preenchimento labial / Free and informed consent terms and its relationship with lip filling procedures

Introdução: Na medida em que envelhecemos os lábios estreitam-se, ocasionando perda de volume e contorno e como forma de minimizar este efeito fisiológico o preenchimento labial de escolha utilizado é o ácido hialurônico. É possível perceber efeitos adversos advindos do emprego deste material, e pelo fato da informação ao paciente ser assegurada pelo Código de Defesa do Consumidor e pelo fato da necessidade dos Cirurgiões-Dentistas terem de esclarecer seus pacientes, o Termo de Consentimento Livre e Esclarecido tornase necessário. Objetivo: identificar, por meio de aplicação de questionário, a percepção de profissionais que trabalham com Harmonização Orofacial em relação a necessidade do emprego do Termo de Consentimento Livre e Esclarecido (TCLE). O questionário apresentou 6 perguntas objetivas, que foram disponibilizadas na plataforma Google Forms®. Material e Método: os dados obtidos foram tabulados em uma planilha eletrônica do programa Microsoft Excel e após analisados descritivamente através de tabelas de frequência, porcentagens e gráficos estatísticos. Resultados: dentre os entrevistados foi constatado que a maioria, 87,5% dos especialistas em Harmonização Orofacial realizam o procedimento de preenchimento labial em sua rotina clínica, e 12,5% não. Conclusão: no presente estudo identificamos que os especialistas realizam o emprego do TCLE, em sua maioria, porém, alguns destes ainda negligenciam o seu uso(AU)

Introduction: As we age, the lips become thinner and to minimize this effect, the lip filler used is hyaluronic acid. It is possible to notice adverse effects arising from the use of this material, and it is extremely important that Dental Surgeons have to clarify their patients, the Free and Informed Consent Form becomes necessary. Objective: to identify, through the application of a questionnaire, the perception of professionals who work with Orofacial Harmonization in relation to the need to use the Free and Informed Consent Form (TCLE). The questionnaire presented 6 objective questions, which were made available on the Google Forms® platform. Materials and Methods: the data obtained were tabulated in a Microsoft Excel spreadsheet and then analyzed descriptively using frequency tables, percentages and graphs. Results: among those interviewed, it was found that the majority, 87.5% of specialists in Orofacial Harmonization perform the lip filling procedure in their clinical routine, and 12.5% do not. With the high percentage of 59.4%, it was possible to verify that the majority of professionals perform 1 to 3 procedures per month; 31.3% perform 4 to 9 procedures per month; and 9.4% of 10 or more monthly procedures. Conclusion: in the present study it was possible to identify that the majority of specialists in Orofacial Harmonization use the informed consent form, however, some of them still neglect its use(AU)

[Informed consent in radiotherapy care]. / Consentement aux soins en radiothérapie.

Obtaining consent to care requires the radiation oncologist to provide loyal information and to ensure that the patient understands it. Proof of such an approach rests with the practitioner. The French Society for Radiation Oncology (SFRO) does not recommend the signature of a consent form by the patient but recommends that the radiation oncologist be able to provide all the elements demonstrating the reality of a complete information circuit.

Principal Features of Industry-Funded Trials that Posted Informed Consent Forms on ClinicalTrials.gov: a Cross-Sectional Analysis.

We aim to characterize industry-funded trials that have posted the informed consent forms (ICFs), and to assess whether the role played by industry as 'sponsor' or 'collaborator' could impact several relevant variables. A cross-sectional study was conducted on ClinicalTrials.gov on all industry-funded trials registered on or before 25 February 2023. We registered types of intervention, current recruitment status, design, enrollment, and countries involved. For trials with special interest to potential participants and investigators and/or clinicians an analysis of the role played by industry as 'sponsor' or 'collaborator' was performed. Of 116,281 industry-funded trials registered, 741 (0.6%) had posted ICFs. Most of these trials were categorized as 'completed' (n = 408) or 'terminated' (n = 107). The review of a sample of 359 trials showed that most were on drugs and/or biologics (59%), were randomized (51%), conducted exclusively in the USA (72%), and had posted results (79%), protocols (92%), and statistical analysis plans (SAPs) (89%). Trials in which industry participated as 'collaborator' were significantly more likely to post ICFs when trials were in the 'active, not recruiting' phase (OR 4.70, 99.71% CI 1.59-13.9, p < 0.001) than industry-sponsored trials. This was also the case when assessing drugs/biologics (OR 2.64, 99.71% CI 1.25-5.58, p < 0.001). Conversely, companies acting as 'sponsors' were significantly more likely to post ICFs with trials assessing devices, radiation interventions and/or diagnostic tests (OR 0.37, 99.71% CI 0.17-0.79, p < 0.001) than when participating as 'collaborators'. While industry-funded trials rarely post ICFs, when they do, they are highly compliant with transparency requirements. Regulations and ethics codes should consider requiring posting of protocols, SAPs, and ICFs for all clinical trials, regardless the type of sponsor.

Consent Form Reporting on ClinicalTrials.Gov, 2013-2023.

This cross-sectional study examines the availability of consent forms for National Institutes of Health­funded trials on ClinicalTrials.gov.

Simplifying informed consent as a universal precaution.

One barrier to participating in clinical research is that patients with low literacy skills (1 in 5 US adults) may struggle to understand the informed consent document (ICD). Writing consents using health literacy and plain language guidelines including simplified syntax and semantics can increase understandability and facilitate inclusivity of research populations with literacy challenges. Our study aim was to evaluate a simplified ICD for understandability while considering factors known to relate to comprehension (reading skills and working memory). We performed an on-line survey of 192 adults ages 18-77 in Georgia. Participants performed significantly better on the simplified ICD test. We built an additional model with all version x measure interactions (i.e., age, sex, race, urbanicity, GMVT, WM). This model did not significantly improve model fit, F < 1.00, suggesting that individual differences did not moderate the effect of simplification. Our findings suggest that using plain language and simplified syntax and semantics in ICD as a universal precaution may reduce cognitive reading burden for adults regardless of differences in reading skill or working memory. Increasing understandability in ICD may help improve targets for clinical trial enrollment.

A taxing problem: The impacts of research payment practices on participants and inclusive research.

Empirical data regarding payments to participants in research is limited. This lack of information constrains our understanding of the effectiveness of payments to achieve scientific goals with respect to recruitment, retention, and inclusion. We conducted a content analysis of consent forms and protocols available on clinicaltrials.gov to determine what information researchers provide regarding payment. We extracted data from HIV (n = 101) and NIMH-funded studies (n = 65) listed on clinicaltrials.gov that had publicly posted a consent form. Using a manifest content analysis approach, we then coded the language regarding payment from the consent document and, where available, protocol for purpose and method of the payment. Although not part of our original planned analysis, the tax-related information that emerged from our content analysis of the consent form language provided additional insights into researcher payment practices. Accordingly, we also recorded whether the payment section mentioned social security numbers (or other tax identification number) in connection with payments and whether it made any statements regarding the Internal Revenue Service or the tax status of payments. We found studies commonly offered payment, but did not distinguish between the purposes for which payment may be offered (i.e., compensation, reimbursement, incentive, or appreciation). We also found studies that excluded some participants from receiving payment or treated them differently from other participants in the study. Differential treatment was typically linked to US tax laws and other legal requirements. A number of US studies also discussed the need to collect Social Security numbers and income reporting based on US tax laws. Collectively, these practices disadvantage some participants and may interfere with efforts to conduct more inclusive research.

Approaches and experiences implementing remote, electronic consent at the Leeds Clinical Trials Research Unit.

BACKGROUND: Use of electronic methods to support informed consent ('eConsent') is increasingly popular in clinical research. This commentary reports the approach taken to implement electronic consent methods and subsequent experiences from a range of studies at the Leeds Clinical Trials Research Unit (CTRU), a large clinical trials unit in the UK. MAIN TEXT: We implemented a remote eConsent process using the REDCap platform. The process can be used in trials of investigational medicinal products and other intervention types or research designs. Our standard eConsent system focuses on documenting informed consent, with other aspects of consent (e.g. providing information to potential participants and a recruiter discussing the study with each potential participant) occurring outside the system, though trial teams can use electronic methods for these activities where they have ethical approval. Our overall process includes a verbal consent step prior to confidential information being entered onto REDCap and an identity verification step in line with regulator guidance. We considered the regulatory requirements around the system's generation of source documents, how to ensure data protection standards were upheld and how to monitor informed consent within the system. We present four eConsent case studies from the CTRU: two randomised clinical trials and two other health research studies. These illustrate the ways eConsent can be implemented, and lessons learned, including about differences in uptake. CONCLUSIONS: We successfully implemented a remote eConsent process at the CTRU across multiple studies. Our case studies highlight benefits of study participants being able to give consent without having to be present at the study site. This may better align with patient preferences and trial site needs and therefore improve recruitment and resilience against external shocks (such as pandemics). Variation in uptake of eConsent may be influenced more by site-level factors than patient preferences, which may not align well with the aspiration towards patient-centred research. Our current process has some limitations, including the provision of all consent-related text in more than one language, and scalability of implementing more than one consent form version at a time. We consider how enhancements in CTRU processes, or external developments, might affect our approach.

When describing harms and benefits to potential trial participants, participant information leaflets are inadequate.

BACKGROUND: Providing informed consent for trials requires providing trial participants with comprehensive information about the trial, including information about potential risks and benefits. It is required by the ethical principle of respecting patient autonomy. Our study examines the variation in the way information about potential trial benefits and harms is shared in participant information leaflets (PILs). METHODS: A total of 214 PILs and informed consent forms from clinical trials units (CTUs) and Clinical Research Facilities (CRFs) in Ireland and the UK were assessed by two authors independently, to check the extent to which they adhered to seven recently developed principles. Discrepancies were resolved by a third. RESULTS: Usage of the seven principles varied widely between PILs regardless of the intended recipient or trial type. None of the PILs used more than four principles, and some (4%) used none. Twenty-seven per cent of PILs presented information about all known potential harms, whereas 45% presented information on all known potential benefits. Some PILs did not provide any potential harms or potential benefits (8%). There was variation in the information contained in adult and children PILs and across disease areas. CONCLUSION: Significant variation exists in how potential trial benefits and harms are described to potential trial participants in PILs in our sample. Usage of the seven principles of good practice will promote consistency, ensure informed ethical decision-making and invoke trust and transparency. In the long term, a standardised PIL template is needed.

Clear aligner therapy informed consent forms: A quality and readability evaluation.

OBJECTIVE: The aim of the present study was to evaluate the quality and readability of content contained within clear aligner therapy (CAT) informed consent forms. METHODS: CAT informed consent forms were identified via an online search. The presence of details related to CAT-related processes, risks, benefits and alternatives in each form was recorded. A 4-point Likert type scale was used to determine the quality of content (QOC). The readability of content was evaluated with the Simple Measure of Gobbledegook (SMOG) and Flesch Reading Ease Score (FRES). RESULTS: A total of 42 forms satisfied selection criteria. Nineteen (45.2%) were authored by companies who provided aligners to patients via clinicians. The QOC regarding CAT-related treatment processes [median 2.0; IQR 0, 2] and benefits [median 2.0; IQR 1, 2] was adequate. The QOC scores regarding treatment alternatives, consequences of no treatment and relapse were poor. There was no difference (P=0.59) in the median (IQR) QOC of the informed consent forms provided by direct-to-consumer (DTC) aligner providers [10 (8.25, 16.25)] and non-DTC aligner providers [12 (10, 14)]. The median (IQR) SMOG score was 12.1 (10.9, 12.7) and FRES was 39.0 (36.0, 44.25). CONCLUSIONS: The QOC of the evaluated forms was incomplete and poor. The content was difficult to read and failed to reach recommended readability standards. Consent is unlikely to be valid if it is based solely on the content of the forms. Clinicians need to be aware of the limitations of informed consent forms for CAT particularly in relation to alternatives, prognosis, risks, and the need for long-term maintenance of results.

The Impact of Using Electronic Consents on Documentation of Language-Concordant Surgical Consent for Patients with Limited English Proficiency.

BACKGROUND: Although access to a professional medical interpreter is federally mandated, surgeons report underutilization during informed consent. Improvement requires understanding the extent of the lapses. Adoption of electronic consent (eConsent) has been associated with improvements in documentation and identification of practice improvement opportunities. The authors evaluated the impact of the transition from paper to eConsent on language-concordant surgical consent delivery for patients with limited English proficiency (LEP). METHODS: The study period (February 8, 2023, to June 14, 2023) corresponds to the period immediately following the institutional adoption of eConsents. Inclusion criteria included age > 18 years, documented preferred language other than English, and self-signed eConsent form. The authors assessed documentation of language-concordant interpreter-mediated verbal consent discussion and delivery of the written surgical consent form in a language-concordant template. Performance was compared to a preimplementation baseline derived from monthly random audits of paper consents between January and December 2022. RESULTS: A total of 1,016 eConsent encounters for patients with LEP were included, with patients speaking 49 different languages, most commonly Spanish (46.5%), Chinese (22.1%), and Russian (6.8%). After the implementation of eConsent, overall documentation of language-concordant interpreter-mediated consents increased from 56.9% to 83.9% (p < 0.001), although there was variation between surgical services and between languages, suggesting that there is still likely room for improvement. Most patients (94.1%) whose preferred language had an associated translated written consent template (Spanish, Chinese, Russian, Arabic), received a language-concordant written consent. CONCLUSION: The transition to eConsent was associated with improved documentation of language-concordant informed consent in surgery, both in terms of providing written materials in the patient's preferred language and in the documentation of interpreter use, and allowed for the identification of areas to target for practice improvement with interpreter use.

Understanding the language barriers to translating informed consent documents for maternal health trials in Zambia: a qualitative study.

OBJECTIVE: Providing comprehensible information is essential to the process of valid informed consent. Recruitment materials designed by sponsoring institutions in English-speaking, high-income countries are commonly translated for use in global health studies in other countries; however, key concepts are often missed, misunderstood or 'lost in translation'. The aim of this study was to explore the language barriers to informed consent, focusing on the challenges of translating recruitment materials for maternal health studies into Zambian languages. DESIGN: We used a qualitative approach, which incorporated a multistakeholder workshop (11 participants), in-depth interviews with researchers and translators (8 participants) and two community-based focus groups with volunteers from community advisory boards (20 participants). Content analysis was used to identify terms commonly occurring in recruitment materials prior to the workshop. The framework analysis approach was used to analyse interview data, and a simple inductive thematic analysis approach was used to analyse focus group data. SETTING: The study was based in Lusaka, Zambia. RESULTS: The workshop highlighted difficulties in translating research terms and pregnancy-specific terms, as well as widespread concern that current templates are too long, use overly formal language and are designed with little input from local teams. Framework analysis of in-depth interviews identified barriers to participant understanding relating to design and development of recruitment materials, language, local context and communication styles. Focus group participants confirmed these findings and suggested potential solutions to ensure the language and content of recruitment materials can be better understood. CONCLUSION: Our findings demonstrate that the way in which recruitment materials are currently designed, translated and disseminated may not enable potential trial participants to fully understand the information provided. Instead of using overly complex institutional templates, recruitment materials should be created through an iterative and interactive process that provides truly comprehensible information in a format appropriate for its intended participants.

What Is "Key Information"? Consideration of the Reasons People Do or Do Not Take Part in Research.

We performed a qualitative review of 50 consent forms posted on Clinicaltrials.gov, examining the content of key information sections. We found that key information disclosures are typically focused on procedures, risks, potential benefits, and alternatives. Drawing upon reviews of the large literature examining the reasons people do or do not take part in research, we propose that these disclosures should be based more directly on what we know to be the real reasons why people choose to take part or refuse participation. We propose key information language for consideration by researchers and institutional review boards.

Comparing Attitudes Toward Different Consent Mediums: Semistructured Qualitative Study.

BACKGROUND: As consent for data sharing evolves with the digital age, plain-text consent is not the only format in which information can be presented. However, designing a good consent form is highly challenging. The addition of graphics, video, and other mediums to use can vary widely in effectiveness; and improper use can be detrimental to users. OBJECTIVE: This study aims to explore the expectations and experiences of adults toward consent given in infographic, video, text, newsletter, and comic forms in a health data sharing scenario to better understand the appropriateness of different mediums and identify elements of each medium that most affect engagement with the content. METHODS: We designed mock consent forms in infographic, video, text, newsletter, and comic versions. Semistructured interviews were conducted with adults who were interviewed about their expectations for consent and were then shown each consent medium and asked about engaging elements across mediums, preferences for consent mediums, and the value of document quality criteria. We transcribed and qualitatively co-coded to identify themes and perform analyses. RESULTS: We interviewed 24 users and identified different thematic archetypes based on participant goals, such as the Trust Seeker, who considered their own understanding and trust in organizations when making decisions. The infographic was ranked first for enhancing understanding, prioritizing information, and maintaining the proper audience fit for serious consent in health data sharing scenarios. In addition, specific elements such as structure, step-by-step organization, and readability were preferred engaging elements. CONCLUSIONS: We identified archetypes to better understand user needs and elements that can be targeted to enhance user engagement with consent forms; this can help inform the design of more effective consent in the future. Overall, preferences for mediums are highly contextual, and more research should be done.

[Nationally standardized broad consent in practice: initial experiences, current developments, and critical assessment]. / National standardisierter Broad Consent in der Praxis: erste Erfahrungen, aktuelle Entwicklungen und kritische Betrachtungen.

BACKGROUND: The digitalization in the healthcare sector promises a secondary use of patient data in the sense of a learning healthcare system. For this, the Medical Informatics Initiative's (MII) Consent Working Group has created an ethical and legal basis with standardized consent documents. This paper describes the systematically monitored introduction of these documents at the MII sites. METHODS: The monitoring of the introduction included regular online surveys, an in-depth analysis of the introduction processes at selected sites, and an assessment of the documents in use. In addition, inquiries and feedback from a large number of stakeholders were evaluated. RESULTS: The online surveys showed that 27 of the 32 sites have gradually introduced the consent documents productively, with a current total of 173,289 consents. The analysis of the implementation procedures revealed heterogeneous organizational conditions at the sites. The requirements of various stakeholders were met by developing and providing supplementary versions of the consent documents and additional information materials. DISCUSSION: The introduction of the MII consent documents at the university hospitals creates a uniform legal basis for the secondary use of patient data. However, the comprehensive implementation within the sites remains challenging. Therefore, minimum requirements for patient information and supplementary recommendations for best practice must be developed. The further development of the national legal framework for research will not render the participation and transparency mechanisms developed here obsolete.

Development of a New Tool for Writing Research Key Information in Plain Language.

BACKGROUND: The complexity of research informed consent forms makes it hard for potential study participants to make informed consent decisions. In response, new rules for human research protection require informed consent forms to begin with a key information section that potential study participants can read and understand. This research study builds on exiting guidance on how to write research key information using plain language. OBJECTIVE: The aim of this study was to develop a valid and reliable tool to evaluate and improve the readability, understandability, and actionability of the key information section on research informed consent forms. METHODS: We developed an initial list of measures to include on the tool through literature review; established face and content validity of measures with expert input; conducted four rounds of reliability testing with four groups of reviewers; and established construct validity with potential research participants. KEY RESULTS: We identified 87 candidate measures via literature review. After expert review, we included 23 items on the initial tool. Twenty-four raters conducted 4 rounds of reliability testing on 10 informed consent forms. After each round, we revised or eliminated items to improve agreement. In the final round of testing, 18 items demonstrated substantial inter-rater agreement per Fleiss' Kappa (average = .73) and Gwet's AC1 (average = .77). Intra-rater agreement was substantial per Cohen's Kappa (average = .74) and almost perfect per Gwet's AC1 (average = 0.84). Focus group feedback (N = 16) provided evidence suggesting key information was easy to read when rated as such by the Readability, Understandability and Actionability of Key Information (RUAKI) Indicator. CONCLUSION: The RUAKI Indicator is an 18-item tool with evidence of validity and reliability investigators can use to write the key information section on their informed consent forms that potential study participants can read, understand, and act on to make informed decisions. [HLRP: Health Literacy Research and Practice. 2024;8(1):e29-e37.].

PLAIN LANGUAGE SUMMARY: Research informed consent forms describe key information about research studies. People need this information to decide if they want to be in a study or not. A helpful form begins with a short, easy-to-read key information section. This study created a tool researchers can use to write the key information about their research people can read, understand, and use.

Returning Clinically Relevant Research Results to Participants: Guidelines for Investigators and the IRB.

In 2019, the revised Common Rule required informed consent documents for research to include a statement about whether clinically relevant research results would be returned to research participants. While there are national discussions regarding the return of results, these do not provide specific guidance about how institutional review boards (IRBs) should address this issue. Through a year-long process involving IRB staff and leadership, science and bioethics faculty members, community IRB members, and others, Indiana University's human research protection program created a framework that offers a clear categorization of types of results for researchers to consider returning, provides language for informed consent documents, and describes an active but intentionally limited role for the IRB. In this article, we describe this framework and its rationale as a model for other universities and, more generally, as a model for balancing the need to protect human subjects with efforts to limit the burdens on researchers and the IRB.

Pediatric Consent on FHIR.

BACKGROUND: Standardizing and formalizing consent processes and forms can prevent ambiguities, convey a more precise meaning, and support machine interpretation of consent terms. OBJECTIVES: Our goal was to introduce a systematic approach to standardizing and digitizing pediatric consent forms, which are complex due to legal requirements for child and legal guardian involvement. METHODS: First, we reviewed the consent requirements from the Arizona regulation, and we used 21 pediatric treatment consents from five Arizona health care organizations to propose and evaluate an implementation-agnostic Consent for Treatment Framework. Second, we assessed the adequacy of the Fast Healthcare Interoperability Resources (FHIR) to support the proposed framework. RESULTS: The resulting Consent for Treatment Framework supports compliance with the state consent requirements and has been validated with pediatric consent forms. We also demonstrated that the FHIR standard has the required expressiveness to compute the framework's specifications and express the 21 consent forms. CONCLUSION: Health care organizations can apply the shared open-source code and FHIR implementation guidelines to standardize the design of machine-interpretable pediatric treatment consent forms. The resulting FHIR-based executable models may support compliance with the law and support interoperability and data sharing.

"Uninformed consent" in clinical trials with cancer patients: A qualitative analysis of patients' and support persons' communication experiences and needs.

OBJECTIVE: Cancer patients are often overwhelmed when being informed about clinical trials. However, there is a lack of evidence-based strategies to improve physician-patient communication in this area. This study assessed the experiences and needs of cancer patients and their support persons (SPs) during the informed consent (IC) process prior to participation in clinical trials. METHODS: 17 semi-structured interviews with cancer patients and their SP were conducted and analysed using a framework analysis. RESULTS: Most respondents reported feeling well informed about the clinical trial. However, core aspects of the study were often not understood highlighting a dissonance between perceived and actual recall and understanding. Many participants trusted that the trial recommended was the best available care and only skimmed the consent form or did not read it at all. CONCLUSIONS: This is the first German study to analyse both cancer patients' and SPs' perspectives on IC processes. Although many feel well informed, our results suggest a significant gap in recall and understanding of core components of clinical trials which hinders IC. PRACTICE IMPLICATIONS: Further interventional research is required to improve the consent processes prior to clinical trials in order to provide optimal, patient-centred care.

Assessing the Readability of Clinical Trial Consent Forms for Surgical Specialties.

INTRODUCTION: To evaluate the readability of surgical clinical trial consent forms and compare readability across surgical specialties. METHODS: We conducted a cross-sectional analysis of surgical clinical trial consent forms available on ClinicalTrials.gov to quantitatively evaluate readability, word count, and length variations among different specialties. The analysis was performed between November 2022 and January 2023. A total of 386 surgical clinical trial consent forms across 14 surgical specialties were included. RESULTS: The main outcomes were language complexity (measured using Flesch-Kincaid Grade Level), number of words (measured as word count), time to read (measured at reading speeds of 240 per min), and readability (measured by Flesch Reading Ease Score, Gunning Frog Index, Simple Measures of Gobbledygook Index, FORCAST, and Automated Readability Index). The surgical consent forms were a mean (standard deviation) of 2626 (1668) words long, with a mean of 12:53 min to read at 240 words per min. None of the surgical specialties had an average readability level of sixth grade or lower across all six indices, and only 16 out of 386 (4%) clinical trials met the recommended reading level. Furthermore, there was no significant difference in reading grade level between surgical specialties based on the Flesch-Kincaid Grade Level and Flesch Reading Ease indices. CONCLUSIONS: Our findings suggest that current surgical clinical trial consent documents are too long and complex, exceeding the recommended sixth-grade reading level. Ensuring readable clinical trial consent forms is not only ethically responsible but also crucial for protecting patients' rights and well-being by facilitating informed decision-making.