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Assessing the transparency of informed consent in feasibility and pilot studies: a single-centre quality assurance study protocol.

ABSTRACT: INTRODUCTION:Pilot/feasibility studies assess the feasibility of conducting a larger study. Although researchers ought to communicate the feasibility objectives to their participants, many research ethics guidelines do not comment on how informed consent applies to pilot studies. It is unclear whether researchers and research ethics boards clearly communicate the purpose of pilot studies to participants consenting.The primary objective of this study is to assess whether pilot/feasibility studies submitted for ethics approval to a research ethics board transparently communicate the purpose of the study to participants through their informed consent practice. A highly transparent consent practice entails the consent documents communicate: (1) the term 'pilot' or 'feasibility' in the title; (2) the definition of a pilot/feasibility study; (3) the primary objectives of the study are to assess feasibility; (4) the specific feasibility objectives; and (5) the criteria for the study to successfully lead to the main study. The secondary objectives are to assess whether there is a difference between submitted and revised versions of the consent documents (revisions are made to obtain research ethics approval), to determine factors associated with transparent consent practices and to assess the consistency with which pilot and feasibility studies assess feasibility outcomes as their primary objectives. METHODS AND ANALYSIS:This is a retrospective review of informed consent information for pilot/feasibility studies submitted to the Hamilton integrated Research Ethics Board, Canada. We will look at submitted and revised consent documents for pilot/feasibility studies submitted over a 14-year period. We will use descriptive statistics to summarise data, reporting results as percentages with 95% CIs, and conduct logistic regression to determine characteristics associated with transparent consent practices. ETHICS AND DISSEMINATION:The study protocol was approved by the Hamilton integrated Research Ethics Board, and the results of this study will be submitted for publication in a peer-reviewed journal.

SUBMITTER: Khan MI

PROVIDER: S-EPMC7311004 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature

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Assessing the transparency of informed consent in feasibility and pilot studies: a single-centre quality assurance study protocol.

Khan Mohammed I MI Holek Matthew M Bdair Faris F Mbuagbaw Lawrence L Eldridge Sandra M SM Chan Claire L CL Campbell Michael J MJ Bond Christine M CM Hopewell Sally S Lancaster Gillian A GA Thabane Lehana L

BMJ open 20200622 6

<h4>Introduction</h4>Pilot/feasibility studies assess the feasibility of conducting a larger study. Although researchers ought to communicate the feasibility objectives to their participants, many research ethics guidelines do not comment on how informed consent applies to pilot studies. It is unclear whether researchers and research ethics boards clearly communicate the purpose of pilot studies to participants consenting.The primary objective of this study is to assess whether pilot/feasibility ...[more]

PMID: 32571863

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Project description:IntroductionDoctors have a legal requirement and duty of care to ensure patients are enabled to make an informed decision about their treatment, including discussion of the benefits, risks and alternatives to a procedure. A patient-centred approach to consent has been firmly established in Ireland, and fundamental to this is the ability to engage in a dialogue that offers comprehensible information to patients. Telemedicine has revolutionised the way we can deliver care to patients in the modern era of computers, tablets, and smartphones, and its use has been rapidly expanded. Novel digital strategies to improve the informed consent process for surgical procedures have been increasingly under investigation over the last 10-15 years and may offer a low cost, accessible and tailored solution to consent for surgical interventions. Within vascular surgery, superficial venous interventions have been associated with a high number medicolegal claims and also represents an area within the specialty with rapidly evolving technology and techniques. The ability to communicate comprehensible information to patients has never been greater. Thus, the author's aim is to explore whether it is feasible and acceptable to deliver a digital health education intervention to patients undergoing endovenous thermal ablation (EVTA) to supplement the consent process.MethodsThis is a prospective, single centre, randomised controlled, feasibility trial recruiting patients with chronic venous disease deemed suitable to undergo EVTA. Patients will be randomised to receive either standard consent (SC) or a newly developed digital health education tool (dHET). The primary outcome is feasibility; assessing the recruitment and retention rate of participants and assessing acceptability of the intervention. Secondary outcomes include knowledge retention, anxiety and satisfaction. This feasibility trial is designed to recruit 40 patients, which will allow for a moderate dropout rate. This pilot study will inform the authors of the appropriateness of an adequately powered multicentre trial.DiscussionTo examine the role of a digital consent solution for EVTA. This may improve and standardise the consent dialogue with patients and may have the potential to reduce claims related to poor consent processes and disclosure of risks.Ethical committee referenceEthical approval has been sought and received from both the Bon Secours Hospital and RCSI (202109017), on 14 May 2021 and 10 October 2021, respectively.Trial registrationClinicalTrials.gov Identifier: NCT05261412 , registered on 1 March 2022.

Project description:BackgroundWe sought to perform a study to record and evaluate patients' views of the way surgeons communicate informed consent (IC) in Greece.Methodology/principal findingsA prospective pilot study was carried out in Athens from 9/2007 to 4/2008. The study sample was extracted from patients, operated by eight different surgeons, who volunteered to fill in a post-surgery self-report questionnaire on IC. A composite delivered information index and a patient-physician relationship index were constructed for the purposes of the analysis. In total, 77 patients (42 males) volunteered to respond to the questionnaire. The delivered information index scores ranged from 3 to 10, the mean score was 8, and the standard deviation (SD) was 1.9. All patients were aware of their underlying diagnosis and reason for surgery. However, a considerable proportion of the respondents (14.3%) achieved a score below or equal to 5. The patient-physician relationship scores ranged from 0 to 20, the mean score was 16 and the standard deviation (SD) was 4.3. The better the patient-physician relationship, the more information was finally delivered to the patient from the physician (Spearman's rank-order correlation coefficient was 0.4 and p<0.001). Delivered information index was significantly higher among participants who comprehended the right to informed consent, compared to participants who did not (p<0.001), and among participants who were given information regarding other possible therapeutic options (p = 0.001). 43% of the respondents answered that less than 10 minutes were spent on the consent process, 58.4% of patients stated that they had not been informed about other possible therapeutic choices and 28.6% did not really comprehend their legal rights to IC.ConclusionsDespite the inherent limitations and the small sample size that do not permit to draw any firm conclusions, results indicate that a successful IC process may be associated with specific elements such as the patient-physician relationship, the time spent by the physician to inform the patient, a participant's comprehension of the right to IC and the provision of information regarding other possible therapeutic options.

Project description: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.

Project description:OBJECTIVE:To 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. DESIGN:Retrospective observational study of informed consent documents. SETTING:25 US hospitals, diverse in size and geographical region. COHORT:Among 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 OUTCOME:The 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. RESULTS:Among 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. CONCLUSION:All 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.

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Assessing the transparency of informed consent in feasibility and pilot studies: a single-centre quality assurance study protocol.

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Assessing the transparency of informed consent in feasibility and pilot studies: a single-centre quality assurance study protocol.

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