Dataset Information

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

ABSTRACT:

Objective

To develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures.

Design

Mixed qualitative-quantitative approach.

Setting

Convened seven meetings with stakeholders to obtain input and feedback on the tool.

Participants

Team 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.

Interventions

With 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.

Outcomes

Abstraction tool to evaluate the quality of informed consent documents.

Results

We 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%.

Conclusions

We 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.

SUBMITTER: Spatz ES

PROVIDER: S-EPMC7247404 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

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

Spatz Erica S ES Suter Lisa G LG George Elizabeth E Perez Mallory M Curry Leslie L Desai Vrunda V Bao Haikun H Geary Lori L LL Herrin Jeph J Lin Zhenqiu Z Bernheim Susannah M SM Krumholz Harlan M HM

BMJ open 20200519 5

<h4>Objective</h4>To develop a nationally applicable tool for assessing the quality of informed consent documents for elective procedures.<h4>Design</h4>Mixed qualitative-quantitative approach.<h4>Setting</h4>Convened seven meetings with stakeholders to obtain input and feedback on the tool.<h4>Participants</h4>Team of physician investigators, measure development experts, and a working group of nine patients and patient advocates (caregivers, advocates for vulnerable populations and patient safe ...[more]

PMID: 32434933

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Project description:One undisputed benefit of digital support is the possibility of contact reduction, which has become particularly important in the context of the COVID-19 pandemic. However, to the best of our knowledge, there is currently no study assessing the Europe-wide use of digital online pre-operative patient information or evaluation in the health sector. The aim of this study was to give an overview of the current status in Europe. A web-based questionnaire covering the informed consent process was sent to members of the European Society of Anaesthesia and Intensive Care Medicine (ESAIC) in 47 European countries (42,433 recipients/930 responses). Six questions related specifically to the practice in paediatrics. A total of 70.2% of the respondents indicated that it was not possible to obtain informed consent via the Internet in a routine setting, and 67.3% expressed that they did not know whether it is in line with the legal regulations. In paediatric anaesthesia, the informed consent of only one parent was reported to be sufficient by 77.6% of the respondents for simple interventions and by 63.8% for complex interventions. Just over 50% of the respondents judged that proof of identity of the parents was necessary, but only 29.9% stated that they ask for it in clinical routine. In the current situation, 77.9% would favour informed consent in person, whereas 60.2% could imagine using online or telephone interviews as an alternative to a face-to-face meeting if regulations were changed. Only 18.7% participants reported a change in the regulations due to the current pandemic situation. Whether informed consent is obtained either online or on the telephone in the paediatric population varies widely across Europe and is not currently implemented as standard practice. For high-risk patients, such as the specific cohort of children with congenital heart defects, wider use of telemedicine might provide a benefit in the future in terms of reduced contact and reduced exposure to health risks through additional hospital stays.

Project description:ImportanceInformed consent is a fundamental element of research ethics. The COVID-19 vaccine trials are high profile trials that have enrolled more than 100 000 participants. Consent documents must be succinct and understandable to ensure informed voluntary participation.ObjectiveTo assess how well informed consent documents of the COVID-19 vaccine trials achieve the ideal of being succinct and understandable, and to create a shorter, more readable document.Design, setting, and participantsThis quality improvement study collected and analyzed the informed consent documents used in 4 COVID-19 vaccine phase III randomized clinical trials to quantitatively assess readability and length and, based on this analysis, created a measurably more accessible informed consent document. Analysis was conducted from October 2020 to January 2021.Main outcomes and measuresThe main outcomes were number of words (measured as word count), time-to-read (measured at reading speeds of 175-300 words per minute), language complexity (measured using Flesch-Kincaid Grade Level assessment), and readability (measured using Flesch Reading Ease Score). Secondary outcomes included clarity of how the placebo group could access the vaccine if it is proven safe and effective. The study also examined the length and readability of an improved consent document.ResultsThe 4 informed consent documents were a mean (range) of 8333 (7821 to 9340) words long, with a mean (range) 35 (32.6 to 38.9) minutes to read at 240 words per minute. All documents exceeded grade 9 language complexity and scored lower than 60 in the formal reading ease metric, which constitutes difficult. Only 1 document specified that participants in the placebo group might receive vaccine. It was possible to write a document in fewer than 3000 words with a grade 7 to 8 reading level and a formal readability score that was not difficult.Conclusions and relevanceThese findings suggest that existing COVID-19 vaccine informed consent documents were too long, difficult to read, and exceeded grade 9 in language complexity. It was possible to create a shorter, more readable informed consent document for these trials.

Project description:BackgroundInformed consent documents for clinical studies should disclose all reasonably foreseeable risks and benefits. Little guidance exists on how to navigate the complexities of risk-benefit communication, especially in early clinical research. Practice-oriented development of such guidance should be informed by evidence on what and how details of risks and benefits are currently communicated.MethodWe surveyed the responsible parties of phase I/II trials registered in ClinicalTrials.gov that started 2007 or later and completed between 2012 and 2016 to sample informed consent documents from a broad spectrum of early phase clinical trials. Based on an assessment matrix, we qualitatively and quantitatively assessed the informed consent documents for details of risk-benefit communication.ResultsThe risk-benefit communication in the 172 informed consent documents differed substantially in several regards. The outcome, extent, and likelihood of health risks, for example, were described in 83%, 32%, and 63% of the informed consent documents. Only 45% of informed consent documents specified the outcome of mentioned health benefits, and the extent and likelihood of health benefits were never specified. From those informed consent documents reporting risk likelihoods, only 57% added frequency numbers to words such as "common" or "rare," and even in these cases, we found strong variations for presented frequency ranges. Substantial heterogeneity also exists for how informed consent documents communicate other risk and benefit types and related safeguards.ConclusionOur study points to several shortcomings and heterogeneities in how informed consent documents communicate risks and benefits to potential research participants. Health risks, for example, should be specified with frequency numbers, and health benefits should be specified at least by mentioning their outcomes. Further demand for research and policy development is needed to harmonize risk-benefit communication and to clarify ways to specify the likelihood of health benefits.

Project description:BackgroundInformed consent-taking is a part of clinical practice that has ethical and legal aspects attached to it. This protects the autonomy of the patients by providing complete information regarding the rationale, modality, potential risks, benefits, and alternatives of the planned procedure to the patients. This enables the patients to make the right decision for themselves and their care. This study aims to find out if the informed consent-taking process has ensured the active participation of the patients or the next of kin in the decision-making.Materials and methodsThis is a prospective cross-sectional study conducted in a military healthcare institution among patients undergoing major surgical procedures from July 2022 to October 2022. Ethical clearance was obtained before the commencement of this study. A structured questionnaire was prepared, and the collected data was refined in Excel and imported into SPSS for analysis.ResultsA total of 350 individuals of mean age 47.95 ± 16.057 years were part of this study. The majority of the respondents were married, literate, and family by beneficiary category. All of the respondents received and signed the consent form. About 77% of the respondents read it completely, and 95.4% of them reported that it was understandable. The majority of the patients did not know who was going to perform the surgery, the alternatives to the planned treatment, the benefits of the surgery, or the outcome of non-treatment. On the patient satisfaction scale, 16.28% of the participants agreed that they were satisfied with the informed consent-taking process.ConclusionDeficiencies in the informed consent-taking process were the lack of dissemination of adequate information on the nature, duration, pros and cons, post-operative state, and alternative of the planned procedure. A well-structured format of the consent form that is specific to a particular procedure should be adopted, and various alternatives to it must be disseminated to the patient or the next of kin to improve the quality of the informed consent-taking process.

Dataset Information

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

Objective

Design

Setting

Participants

Interventions

Outcomes

Results

Conclusions

Publications

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

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