Atlas.ti
ATLAS.ti is a powerful workbench for the qualitative analysis of large bodies of textual, graphical, audio and video data.
Initial citation from Informed Consent Monthly Review
Brief Psychiatric Rating Scale (BPRS)
Persons having or suspected of having schizophrenia or other psychotic disorder manifest the disorder in multiple ways. The BPRS assesses the level of 18 symptom constructs such as hostility, suspiciousness, hallucination, and grandiosity. It is particularly useful in gauging the efficacy of treatment in patients who have moderate to severe psychoses.
Initial citation from Informed Consent Monthly Review
Capacity Assessment Tool (CAT)
The CAT is a structured evaluation of the participant’s decision-making capacity for a specific medical decision based on six abilities: communication, understanding choices, comprehension of risks and benefits, insight, decision/choice process, and judgment.
Initial citation from Informed Consent Monthly Review
Constant Comparison Method
Constant comparison is the data-analytic process whereby each interpretation and finding is compared with existing findings as it emerges from the data analysis.
Initial citation from Informed Consent Monthly Review
Decision-Making Capacity Assessments (DMCA)
Adults are presumed to be independent decision-makers regarding their personal and financial affairs. When a person’s decision-making capacity (DMC) in specific domains, however, comes into question due to diseases such as dementia and other chronic conditions, standardized Decision-Making Capacity Assessment (DMCA) processes aligned with legislation are needed.
Initial citation from Informed Consent Monthly Review
DICE
Web-based electronic informed consent application.
Initial citation from Informed Consent Monthly Review
Flesch-Kincaid Readability Scale
Readability test that tell what level of education someone needs to easily read a piece of text.
Initial citation from Informed Consent Monthly Review
Gillick Competence
The [term used] … to identify children aged under 16 who have the legal competence to consent to immunization, providing they can demonstrate sufficient maturity and intelligence to understand and appraise the nature and implications of the proposed treatment, including the risks and alternative courses of actions. Gillick competence is a functional ability to make a decision.
Initial citation from Informed Consent Monthly Review
Grounded Theory approach
Grounded theory sets out to discover or construct theory from data, systematically obtained and analysed using comparative analysis.
Initial citation from Informed Consent Monthly Review
Hamilton Anxiety Rating Scale, HAM-A
The HAM-A was one of the first rating scales developed to measure the severity of anxiety symptoms, and is still widely used today in both clinical and research settings. The scale consists of 14 items, each defined by a series of symptoms, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety).
Initial citation from Informed Consent Monthly Review
Hierarchic Dementia Scale-Revised
The Hierarchic Dementia Scale-Revised (HDS-R) is a comprehensive assessment of cognitive abilities for people with dementia. It measures 20 different cognitive functions rating each one on a hierarchy. It can be used across the entire course of dementia from diagnosis through to end-of-life care.
Initial citation from Informed Consent Monthly Review
Hopkins Competency Assessment Test (HCAT)
The Hopkins Competency Assessment Test (HCAT) is a brief instrument for evaluating the competency of patients to give informed consent or write advance directives, which consists of a short essay and a questionnaire for determining patients’ understanding of the essay.
Initial citation from Informed Consent Monthly Review
Inflesz Readability Scale
The Inflesz Readability Scale was developed for Spanish language texts. The scale uses five readability levels: “Difficult” (<40), “Slightly Difficult” (40-55), “Normal (Average)” (55-65), “Easy” (65-80), and “Very Easy” (>80). This scale is more aligned with Spanish reading habits and offers a more nuanced understanding of readability levels compared to its predecessors.
Initial citation from Informed Consent Monthly Review
Informed Consent Evaluation Feedback Tool (ICEFbT)
The Informed Consent Evaluation Feedback Tool (ICEFbT) helps direct and evaluate the informed consent process and compliance by providing a list of questions which may help potential participants to clarify and indentify gaps in their understanding. It is necessary to develop tools that allow both the researchers and Institution Review Board (IRB) of the universities and research institutes to evaluate the quality of the IC process and procedure before starting research procedures.
Initial citation from Informed Consent Monthly Review
Informed Consent Form Navigator
The ICF Navigator is a web-based tool that guides researchers through creating an ICF as they answer questions about their project. The navigator helps guide the creation of study-specific language, ensures compliance with regulatory requirements, and ensures that the resulting ICF is easy to read and understand.
Initial citation from Informed Consent Monthly Review
Likert Scale
A five or seven point rating scale [used] to measure attitudes directly, it allow[s] the individual to express how much they agree or disagree.
Initial citation from Informed Consent Monthly Review
MacArthur Competence Assessment Tool for Treatment (MacCAT-T)
the MacArthur Competence Assessment Tool-Treatment (MacCAT-T) was developed for use by clinicians. The instrument assesses patients’ competence to make treatment decisions by examining their capacities in four areas, understanding information relevant to their condition and the recommended treatment, reasoning about the potential risks and benefits of their choices, appreciating the nature of their situation and the consequences of their choices, and expressing a choice.
Initial citation from Informed Consent Monthly Review
Meaning Equivalence Reusable Learning Objectives (MERLO)
Multi-dimensional database that allows the sorting and mapping of important concepts through exemplary target statements of conceptual situations, and relevant statements of shared meaning.
Initial citation from Informed Consent Monthly Review
Mini Mental State Examination
The mini mental state examination (MMSE) is a commonly used set of questions for screening cognitive function. This examination is not suitable for making a diagnosis but can be used to indicate the presence of cognitive impairment, such as in a person with suspected dementia or following a head injury.
Initial citation from Informed Consent Monthly Review
Oxford Video Informed Consent Tool (OxVIC)
Personalised video consent tool to enhance patient satisfaction in the preoperative consenting process.
Initial citation from Informed Consent Monthly Review
Quality of Informed Consent (QuIC) questionnaire
The QuIC questionnaire was developed to assess research participants’ comprehension of the consent requirements stipulated by United States Federal Regulations. The instrument includes at least one objective test item for each consent requirement and additional objective and subjective test items. The added objective items measure understanding of difficult clinical trial concepts as noted in empirical research studies such as: placebo, therapeutic misconception, and blinding. The subjective items evaluate how well participants ‘feel’ they understand the clinical trial.
Initial citation from Informed Consent Monthly Review
REDCap
REDCap is a secure web application for building and managing online surveys and databases.
Initial citation from Informed Consent Monthly Review
Research Kit
ResearchKit, developed by Apple, is an open-source software framework designed to streamline the process of screening and consenting participants into research studies.
Initial citation from Informed Consent Monthly Review
Revised Hasegawa Dementia Scale
Revised Hasegawa’s dementia scale (HDS-R) consists of 9 simple questions.
Initial citation from Informed Consent Monthly Review
Structured Interview for Competency/Incompetency Assessment Testing, Ranking Inventory (SICIATRI)
The Structured Interview for Competency and Incompetency Assessment Testing and Ranking Inventory (SICIATRI) is a structured interview guide to assess the competency for giving informed consent to treatment among psychiatric and medical patients.
Initial citation from Informed Consent Monthly Review
The System Usability Scale (SUS)
Provides a quick and reliable tool for measuring usability. It consists of a 10-item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.
Initial citation from Informed Consent Monthly Review
Teach Back
Teach-back is a way to confirm that the educator has explained to the patient what is important and in a manner that the patient understands. Patient understanding is confirmed when the patient explains it back in their own words to the educator. It can also help the clinician identify explanations and communication strategies that are most commonly misunderstood by patients.
Initial citation from Informed Consent Monthly Review
Theoretical Framework of Acceptability
The theoretical framework of acceptability (TFA) was developed in response to recommendations that acceptability should be assessed in the design, evaluation and implementation phases of healthcare interventions. The TFA consists of seven component constructs (affective attitude, burden, ethicality, intervention coherence, opportunity costs, perceived effectiveness, and self-efficacy) that can help to identify characteristics of interventions that may be improved.
Initial citation from Informed Consent Monthly Review
University of California, San Diego Brief Assessment of Capacity to Consent (UBACC)
The UBACC is intended to help investigators identify research participants who warrant more thorough decisional capacity assessment and/or remediation efforts prior to enrollment.
Initial citation from Informed Consent Monthly Review
[last updated 20 February 2024]
Center for Informed Consent Integrity 