Participants' Comprehension of the Informed Consent in an Epidemiological Study on Dementia Prevalence: A Qualitative Study

Aim: In the absence of an effective treatment, informed participation in dementia research can hardly be underestimated. However, although informed consent is key in biomedical research, it may become a barrier to participation. Whether informed consent may cause confusion and contribute to unfair participant selection in dementia research is not known. In preparation of a future epidemiological study on the prevalence and impact of dementia in Switzerland, we aimed to conduct a qualitative study to explore participants' comprehension of the purpose of informed consent form and process shortly after participation in the pilot and validation study that preceded the large scale survey.Methods: We conducted a qualitative study with 22 participants of the validation phase of an epidemiological study on the prevalence and impact of dementia in Switzerland to capture their understanding of both the nature and the content of the informed consent form and process. Participants were older adults (65 years or more) eligible for a dementia epidemiological study and their informant (a person who could provide information on their health and cognition). None of the participants reported to be suffering from dementia at the time of the interview.Results: We found that participants held inaccurate and potentially trust-threatening beliefs regarding the scope of the informed consent. Participants identified contradictory contextual, formal and content needs that are difficult to be fulfilled, and misperceived the clinical and research settings in terms of informed consent procedures.Conclusions: Participants and their proxies should be informed about both the scope of the informed consent process, and the content of the informed consent document in a focused, age-appropriate manner, while dispelling confusion about the purpose of research.

Dilemma of the differential diagnosis of hilar cholangiocarcinoma and benign diseases:a single-center retrospective study

Hilar cholangiocarcinoma, which lacks specific clinical manifestations, remains very difficult to distinguish from benign disease. This distinction is further complicated by the complex hilar anatomy. We conducted the present study to evaluate the differential diagnosis of these conditions. Sixty-five patients underwent resection surgery for suspected hilar cholangiocarcinoma between January 2011 and October 2018. Institutional Review Board of Shengjing hospital agreed this study and all particpants sign an informed consent document prior to participation in a research study. Following a postoperative pathology analysis, all patients were divided into 2 groups: malignant group (54 patients with HCCA) and benign group (11 cases with benign lesions). Compared to the benign group, the malignant group had a significantly higher median age and serum CA19-9, CEA, ALT, BILT, and BILD levels (P <0.05). By contrast, the groups did not differ significantly in terms of the sex distribution, clinical manifestations, serum levels of AST and ALKP, and imaging findings. In a receiver operating characteristic curve analysis, we identified a CA19-9 cut-off point of 233.15 U/ml for the differential diagnosis and CEA cut-off point of 2.98 ng/ml for the differential diagnosis. The differential diagnosis of HCCA and benign hilar lesions remains difficult. However, we found that patients with HCCA tended to have an older age at onset and higher serum levels of CA19-9, CEA, BILT, ALT, and BILD. Furthermore, patients with a serum CA19-9 level >233.15 U/ml and CEA level >2.98 ng/ml are more likely to have malignant disease.

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.

Feasibility of “Sit Less, Move More”: An intervention for reducing sedentary behavior Among African Americans with MS

Background Sedentary behavior is a major concern in multiple sclerosis, as it may accelerate disease progression and physical disability. This is especially concerning in African Americans, who present with greater neurological disability than Caucasians. Objective We conducted a feasibility trial on an intervention targeting sedentary behavior in African Americans with multiple sclerosis. Methods We examined the feasibility of the Sit Less, Move More program, a 12-week behavioral intervention that used text messaging along with theory-driven newsletters and behavioral coaching for managing sedentary behavior. We recruited ambulatory, inactive, African Americans with multiple sclerosis, and assessed feasibility on process, resource, management, and scientific outcomes. Results Of the 64 people initially contacted, 45 were assessed for eligibility, 31 were sent the informed consent document, and 30 returned a signed document and were included in the study. Study costs were US$7242.38. Personnel time to complete the study was 130 h. There was a small effect on both device-measured ( d = −0.19) and self-reported ( d = −0.39) sedentary behavior. Conclusions The Sit Less, Move More intervention is safe and feasible for African Americans with multiple sclerosis, and yielded a small reduction in sedentary behavior. The intervention was low cost and well received. Our results suggest the Sit Less, Move More program should progress towards a Phase II trial to determine its efficacy.

Study of Awareness and Practice of Informed Consent Process Among Clinical Trial Participants and Their Motives Behind Participation

Process to obtain informed consent is an essential component in research involving human subjects. However, much is not known about the level of awareness participants have about optimal consenting process and the motives that drive their participation in the trials. A cross-sectional study was conducted among volunteers who had been participating in clinical trials in contract research organizations of Delhi. Validated questionnaires were used to assess their knowledge, attitude, and practice of informed consent process. Most of the volunteers, 226 (56.5%), had participated in 1 to 3 clinical trials. Majority (54%) were unaware about any informed consent document. None of them were aware of their right of profession competence, privacy and integrity, transparency, nonexploitation, and nonusage of their biological samples. Effective implementation of principles of informed consenting is largely lacking among contract research organizations in Delhi, India. This could potentially cause risk to the participants.

Implementing a New Common Rule Requirement for Informed Consent: A Randomized Trial on Adult Asthma Patients

Objectives. To determine how the format of a clinical trial informed consent document can affect participants’ retention of enrollment-relevant information. Background. Recent changes to the US Federal Common Rule require informed consent documents for clinical trials to be concise and start with the information most relevant for enrollment decisions. However, there is limited guidance on how to identify this information or evaluate its impact. Design. Participants with a self-reported asthma diagnosis were randomized to one of five versions of the informed consent document for a clinical trial of an injectable asthma product: the original, full-length document; a concise version, removing information identified by asthma patients in an earlier study as not relevant to their enrollment decisions; an interactive version, where participants self-navigated to the information they chose; a reordered version, moving up information deemed more relevant for enrollment in an earlier study; and a highlights version, following the suggested revised Common Rule structure, starting with a summary of enrollment-relevant information based on patient ratings. Knowledge acquisition was evaluated with a knowledge test, with submeasures for information that had high and low relevance for enrollment decisions. Results. Participants who saw the highlights (“Common Rule”) version were more likely to answer questions about high enrollment-relevant information correctly than were participants who saw the full-length version (65% v 59%, P = 0.0105). Participants who saw the other revised versions did not perform significantly differently from the full-length version. Conclusions. An informed consent document designed to implement revised US Federal Common Rule requirements performed better than other designs, in terms of readers retaining information relevant for clinical trial enrollment, as characterized by potential trial participants in a separate study.