KNOWLEDGE AND AWARENESS OF INFORMED CONSENT AMONG DENTAL PATIENTS

Obtaining informed consent from the patient is fundamental. The consent document should be in local language and should be simple and easy to understand. The awareness and knowledge on informed consent among both patients and the physician is essential in order to practice an efficient process as it is a continuous, two- way communication where transparency and partnership plays an important role.This study was undertaken to examine patients knowledge and awareness about informed consent process. 100 patients attending the Out Patient department were interviewed through questionnaire to assess the awareness and knowledge of the informed consent process. The present study revealed the percentage of patients who were aware of the informed consent process and the information provided in it.

Effectiveness of Buteyko Breathing Technique versus Nadi Shuddhi Pranayama to Improve Pulmonary Function in Subjects with Bronchial Asthma

Background: Asthma is a chronic life-threatening disease as the airways in the lungs often swollen or inflamed, which makes the airways very sensitive. So, the exposure to the environment in day-to-day life triggers asthma. Asthma can affect at any age group. This study mainly focuses on comparing the effects of Buteyko breathing technique and Pranayama on improving Pulmonary Function in subjects with Bronchial Asthma. Method: Total of 79subjects selected, out of those 66 subjects were included after obtaining the consent document. Subjects are divided into two groups by lottery method, in which 6 subjects dropped. So, the study was completed with 60 subjects. Both groups performed intervention for 1 hour a day 5 days week for 4 weeks. The outcomes of the study were FEV1, FVC & FEV1/FVC ratio. Results: Paired t test was used to assess statically significance between pre and post test scores with in the groups, independent t test was used to access statistical significance of post-test mean score between the groups, statistical analysis of the data revealed that Buteyko Breathing technique group has more difference when compare to Pranayama group. Conclusion: The results had shown that both Group-A (Buteyko Breathing Group) and Group-B (Pranayama Group) has improved significantly on pre and post-test values within the groups but when compared between the groups statistical significance is noted in Group-A. So, this study concludes that Group-A showed significant improvement on Pulmonary Function in subjects with Bronchial Asthma. Keywords: Buteyko Breathing technique, Nadishuddhi Pranayama, FEV1/FVC, Bronchial Asthma.

Informed Consent, the Ethical Cornerstone of Medical Intervention, Especially within the Conduct of Clinical Trials

Introduction: This paper outlines and explains a new approach to informed consent, especially within clinical trials. Background: Autonomy implies the patient has control for what happens to his/her body. There is a problem with lack of equipoise between clinician and patient, especially when the clinician, conducting a trial, is also the patient’s physician. Beran et al adopted a novel approach to informed consent, especially within clinical trials. The patient is introduced to the trial coordinator who assumes responsibility of discussing the nature, risks and benefits of the trial. If the patient accepts and signs the informed consent document, with the coordinator, the doctor counter-signs it, offering the opportunity to ask further questions, criticize the process and feel confident that the decision was correct. Discussion: Where the investigator is also the patient’s treating clinician, it must be recognized that there might be a perception of potential coercion, asking a patient to join a trial. The practice employed a trial coordinator, a recent university, science graduate, a young person with less influence over the patient. Patients completed the bulk of the informed consent with the trial coordinator, given every opportunity to decline inclusion into a trial. With the trial coordinator, being responsible for discussing the elements of the trial, there is a reduced potential for undue influence, with ultimate respect for autonomy and selfdetermination. This procedure offers a novel approach to gain informed consent for inclusion in clinical trials with the doctor retaining ultimate responsibility, for informed consent, and countersigning the consent document.

Applying a Digital Health Checklist and Readability Tools to Improve Informed Consent for Digital Health Research

Background: As research involving human participants increasingly occurs with the aid of digital tools (e.g., mobile apps, wearable and remote pervasive sensors), the consent content and delivery process is changing. Informed consent documents to participate in research are lengthy and difficult for prospective participants to read and understand. As the consent communication will need to include concepts and procedures unique to digital health research, making that information accessible and meaningful to the prospective participant is critical for consent to be informed. This paper describes a methodology that researchers can apply when developing a consent communication for digital health research.Methods: A consent document approved by a US institutional review board was deconstructed into segments that aligned with federal requirements for informed consent. Three researchers independently revised each segment of text with a goal of achieving a readability score between a 6–8th grade level. The team then consulted with an external readability expert well-versed in revising informed consent documents into “plain language.” The resulting text was evaluated using Microsoft Word and Online-Utility accessibility software. The final step involved adding visual images and graphics to complement the text. The Digital Health Checklist consent prototype builder was then used to identify areas where the consent content could be expanded to address four key domains of Access and Usability, Privacy, Risks and Benefits, and Data Management.Results: The approved consent was evaluated at a 12.6 grade reading level, whereas the revised language by our study team received 12.4, 12, and 12.58, respectively. The final consent document synthesized the most readable of the three revised versions and was further revised to include language recommended by the software tool for improving readability, which resulted in a final revised consent readability score of a 9.2 grade level. Moreover, word count was reduced from 6,424 in the original consent to 679 in the rewritten consent form.Conclusion: Utilizing an iterative process to design an accessible informed consent document is a first step in achieving meaningful consent to participate in digital health research. This paper describes how a consent form approved by an institutional review board can be made more accessible to a prospective research participant by improving the document readability score, reducing the word count and assessing alignment with the Digital Health Checklist.

Development and evaluation of an online, patient-driven, family outreach intervention to facilitate sharing of genetic risk information in families with Lynch syndrome

BackgroundIdentifying at-risk relatives of individuals with genetic conditions facilitates ‘cascade’ genetic testing and cancer prevention. Although current standards of care give mutation-positive (index) patients the responsibility of sharing genetic risk information with relatives, the communication is suboptimal, limited largely to close relatives. We developed FamilyCONNECT, a provider-mediated, patient-navigated online tool to facilitate family outreach, and assessed its feasibility, usability and acceptability.Methods(1) Development of the FamilyCONNECT prototype; (2) testing using online surveys of: (a) members of Lynch Syndrome (LS) International (LSI); (b) genetics service providers; and (3) hands-on testing with patients with LS.Results(1) FamilyCONNECT’s features include introductory email to elicit participation, informational website/video, identity authentication/account creation, informed consent, sharing of genetic test results, pedigree expansion and process to invite at-risk relatives. (2a) 33% of the 170 LSI participants completed the survey. FamilyCONNECT’s features received favourable responses from at least 79% of respondents. Unfavourable responses were for length of the consent document and mistrust of opening emailed links. (2b) Thirty-five genetics professionals responded to the providers’ survey. Key perceived barriers to FamilyCONNECT’s usage were privacy/confidentiality (83%), a lack of institutional resources (76%), a defined process (66%) and time (69%). (3) Ten patients navigated data collection fields and provided feedback for improvements.ConclusionFamilyCONNECT tool’s content and features were well received among patients with LS as well as providers. The tool could be a viable alternative to increase family outreach among patients with LS. Future efforts will focus on refining FamilyCONNECT and assessing its uptake and utilisation by patients with LS.

Informed Consent Position in Doctor and Patient Relationship

Awareness of risks may be interpreted as a patient's approval in the context of submitting the doctor's schedule with the necessary details for making an appointment or an informed refuse. Prior to signing the consent document, the agreement, the prospective student already confirmed that she understood the terms and conditions. to let the patient understand anything before doing it, and when making the judgment, the patient should make the most of any of an exhaustive information (informed decision). The kinds of studies found in this paper are what lawyers refer to as "normative" studies. The nature of this analysis is informative, and is research that outlines, discusses, illustrates, and analyzes legal rules pertaining to the role of consent in the doctor and patient's relationship. Patients are given the right to know regarding the medical activities, outlined in Regulation Minister of Health (Per) No. 290 on Approval of Medical Actions, prior to accessing treatment. As seen from the standpoint of the idea of unauthorized consent (considered given), the patient-doctor partnership becomes complicated. This issue revolves around the concept of informed consent, which is essentially an assumption that the patient has already agreed to carry out medical procedures with the doctor prior to seeking medical treatment.

Negotiating informed consent: A students-as-partners perspective

Building on our 2019 ISSOTL poster presentation, we (Michael: a tenured English Department faculty member; and Emily: an undergraduate English major) are developing a reflective essay about our in-progress SaP project designed to assess the effectiveness of recent university system mandated curricular changes to multiple sections of an introductory college-level writing course at our home institution, the University of North Georgia, USA. Even though we received the necessary institutional and federal government permissions to conduct this research, and even though the research participants signed the necessary informed consent document, as we continue our data collection we wonder how we might better listen and watch for what Bivens (2018) calls “microwithdrawals of consent.” Bivens describes this phenomenon as the “implied or partial halt of a person’s willingness to participate in one or more aspects of the research process and the researcher’s awareness of that withdrawal.” Bivens calls on researchers to stay attuned to the participant’s body language and vocal tone to notice when participants may want to withdraw consent but not explicitly say so. When undergraduate researchers conduct interviews with other undergraduates, they are well-positioned to perceive these microwithdrawals of consent. With Emily as the lead author for this proposed piece, we wonder: How can students working in partnership with faculty help faculty better understand how informed consent is an on-going and negotiated process that does not end when research participants sign a consent document? Pondering this question emphasizes the “messy, ‘work in progress’ nature of SaP” (Matthews, 2017, p. 4), which, we argue should hold a central place in our SaP publications.

Quality of informed consent documents among US. hospitals: a cross-sectional study

ObjectiveTo determine whether informed consent for surgical procedures performed in US hospitals meet a minimum standard of quality, we developed and tested a quality measure of informed consent documents.DesignRetrospective observational study of informed consent documents.Setting25 US hospitals, diverse in size and geographical region.CohortAmong Medicare fee-for-service patients undergoing elective procedures in participating hospitals, we assessed the informed consent documents associated with these procedures. We aimed to review 100 qualifying procedures per hospital; the selected sample was representative of the procedure types performed at each hospital.Primary outcomeThe outcome was hospital quality of informed consent documents, assessed by two independent raters using an eight-item instrument previously developed for this measure and scored on a scale of 0–20, with 20 representing the highest quality. The outcome was reported as the mean hospital document score and the proportion of documents meeting a quality threshold of 10. Reliability of the hospital score was determined based on subsets of randomly selected documents; face validity was assessed using stakeholder feedback.ResultsAmong 2480 informed consent documents from 25 hospitals, mean hospital scores ranged from 0.6 (95% CI 0.3 to 0.9) to 10.8 (95% CI 10.0 to 11.6). Most hospitals had at least one document score at least 10 out of 20 points, but only two hospitals had >50% of their documents score above a 10-point threshold. The Spearman correlation of the measures score was 0.92. Stakeholders reported that the measure was important, though some felt it did not go far enough to assess informed consent quality.ConclusionAll hospitals performed poorly on a measure of informed consent document quality, though there was some variation across hospitals. Measuring the quality of hospital’s informed consent documents can serve as a first step in driving attention to gaps in quality.

An instrument for assessing the quality of informed consent documents for elective procedures: development and testing

ObjectiveTo develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures.DesignMixed qualitative-quantitative approach.SettingConvened seven meetings with stakeholders to obtain input and feedback on the tool.ParticipantsTeam of physician investigators, measure development experts, and a working group of nine patients and patient advocates (caregivers, advocates for vulnerable populations and patient safety experts) from different regions of the country.InterventionsWith stakeholder input, we identified elements of high-quality informed consent documents, aggregated into three domains: content, presentation and timing. Based on this comprehensive taxonomy of key elements, we convened the working group to offer input on the development of an abstraction tool to assess the quality of informed consent documents in three phases: (1) selecting the highest-priority elements to be operationalised as items in the tool; (2) iteratively refining and testing the tool using a sample of qualifying informed consent documents from eight hospitals; and (3) developing a scoring approach for the tool. Finally, we tested the reliability of the tool in a subsample of 250 informed consent documents from 25 additional hospitals.OutcomesAbstraction tool to evaluate the quality of informed consent documents.ResultsWe identified 53 elements of informed consent quality; of these, 15 were selected as highest priority for inclusion in the abstraction tool and 8 were feasible to measure. After seven cycles of iterative development and testing of survey items, and development and refinement of a training manual, two trained raters achieved high item-level agreement, ranging from 92% to 100%.ConclusionsWe identified key quality elements of an informed consent document and operationalised the highest-priority elements to define a minimum standard for informed consent documents. This tool is a starting point that can enable hospitals and other providers to evaluate and improve the quality of informed consent.