Exploring consumer opinions on the presentation of side‐effects information in Australian Consumer Medicine Information leaflets

Abstract

BackgroundConsumer Medicine Information (CMI) is a brand‐specific and standardized source of written medicine information available in Australia for all prescription medicines. Side‐effect information is poorly presented in CMI and may not adequately address consumer information needs.ObjectiveTo explore consumer opinions on (i) the presentation of side‐effect information in existing Australian CMI leaflets and alternative study‐designed CMIs and (ii) side‐effect risk information and its impact on treatment decision making.DesignFuzzy trace, affect heuristic, frequency hypothesis and cognitive‐experiential theories were applied when revising existing CMI side‐effects sections. Together with good information design, functional linguistics and medicine information expertise, alternative ramipril and clopidogrel CMI versions were proposed. Focus groups were then conducted to address the study objectives.Participants and settingThree focus groups (n = 18) were conducted in Sydney, Australia. Mean consumer age was 58 years (range 50–65 years), with equal number of males and females.ResultsAll consumers preferred the alternative CMIs developed as part of the study, with unequivocal preference for the side‐effects presented in a simple tabular format, as it allowed quick and easy access to information. Consumer misunderstandings reflected literacy and numeracy issues inherent in consumer risk appraisal. Many preferred no numerical information and a large proportion preferred natural frequencies.ConclusionsOne single method of risk presentation in CMI is unable to cater for all consumers. Consumer misunderstandings are indicative of possible health literacy and numeracy factors that influence consumer risk appraisal, which should be explored further.

Patients' opinions on metoprolol, as expressed on the Internet - an exploratory, qualitative study

“…According to experts, this section is poorly written and thus critically assessed by patients. [22] These facts confirm our observations. Undoubtedly, Internet forums are influential sources of consumer information.…”

Patients' opinions on metoprolol, as expressed on the Internet - an exploratory, qualitative study

“…According to experts, this section is poorly written and thus critically assessed by patients. [22] These facts confirm our observations. Undoubtedly, Internet forums are influential sources of consumer information.…”

Consumer interpretation of ramipril and clopidogrel medication risk information – implications for risk communication strategies

“……”

Providing Balanced Information about Options in Patient Decision Aids: An Update from the International Patient Decision Aid Standards

“…The 2013 IPDAS update defined balanced presentation of information and options as “complete and unbiased presentation of the relevant options and the information about those options—in content and in format—in a way that enables individuals to process this information without bias.” 21 This elaborated specific details on information presented in PtDAs to include the condition, procedures involved in each option, potential benefits, side effects and potential harms, and other information based on assessing individual patients’ needs. 21 The findings of our scoping review underscore the importance of avoiding framing effects that could negatively influence the patients’ interpretation of the information 36,40,42 as well as a need for elaboration of the attributes and indicators by which balanced information can be more fully assessed.…”

“…21 This elaborated specific details on information presented in PtDAs to include the condition, procedures involved in each option, potential benefits, side effects and potential harms, and other information based on assessing individual patients' needs. 21 The findings of our scoping review underscore the importance of avoiding framing effects that could negatively influence the patients' interpretation of the information 36,40,42 as well as a need for elaboration of the attributes and indicators by which balanced information can be more fully assessed.…”

“…Twelve articles provided background describing the definition or rationale related to presenting balanced information about options (Table 2). 7,21,25–35 Eight articles were experimental studies evaluating the balance or bias in the information presentation (Table 3), 36–43 and 42 articles quantitatively reported the views of patients, family, carers, and health care professionals who rated the patient decision aid as a balanced presentation (Table 4). 29,44–82…”

Patients' opinions on metoprolol, as expressed on the Internet - an exploratory, qualitative study

“…According to experts, this section is poorly written and thus critically assessed by patients. [22] These facts confirm our observations. Undoubtedly, Internet forums are influential sources of consumer information.…”

Consumer interpretation of ramipril and clopidogrel medication risk information – implications for risk communication strategies

“……”

Providing Balanced Information about Options in Patient Decision Aids: An Update from the International Patient Decision Aid Standards

“…The 2013 IPDAS update defined balanced presentation of information and options as “complete and unbiased presentation of the relevant options and the information about those options—in content and in format—in a way that enables individuals to process this information without bias.” 21 This elaborated specific details on information presented in PtDAs to include the condition, procedures involved in each option, potential benefits, side effects and potential harms, and other information based on assessing individual patients’ needs. 21 The findings of our scoping review underscore the importance of avoiding framing effects that could negatively influence the patients’ interpretation of the information 36,40,42 as well as a need for elaboration of the attributes and indicators by which balanced information can be more fully assessed.…”

“…21 This elaborated specific details on information presented in PtDAs to include the condition, procedures involved in each option, potential benefits, side effects and potential harms, and other information based on assessing individual patients' needs. 21 The findings of our scoping review underscore the importance of avoiding framing effects that could negatively influence the patients' interpretation of the information 36,40,42 as well as a need for elaboration of the attributes and indicators by which balanced information can be more fully assessed.…”

“…Twelve articles provided background describing the definition or rationale related to presenting balanced information about options (Table 2). 7,21,25–35 Eight articles were experimental studies evaluating the balance or bias in the information presentation (Table 3), 36–43 and 42 articles quantitatively reported the views of patients, family, carers, and health care professionals who rated the patient decision aid as a balanced presentation (Table 4). 29,44–82…”

Patients' opinions on metoprolol, as expressed on the Internet - an exploratory, qualitative study

“…According to experts, this section is poorly written and thus critically assessed by patients. [22] These facts confirm our observations. Undoubtedly, Internet forums are influential sources of consumer information.…”

Consumer interpretation of ramipril and clopidogrel medication risk information – implications for risk communication strategies

“……”

Providing Balanced Information about Options in Patient Decision Aids: An Update from the International Patient Decision Aid Standards

“…The 2013 IPDAS update defined balanced presentation of information and options as “complete and unbiased presentation of the relevant options and the information about those options—in content and in format—in a way that enables individuals to process this information without bias.” 21 This elaborated specific details on information presented in PtDAs to include the condition, procedures involved in each option, potential benefits, side effects and potential harms, and other information based on assessing individual patients’ needs. 21 The findings of our scoping review underscore the importance of avoiding framing effects that could negatively influence the patients’ interpretation of the information 36,40,42 as well as a need for elaboration of the attributes and indicators by which balanced information can be more fully assessed.…”

“…21 This elaborated specific details on information presented in PtDAs to include the condition, procedures involved in each option, potential benefits, side effects and potential harms, and other information based on assessing individual patients' needs. 21 The findings of our scoping review underscore the importance of avoiding framing effects that could negatively influence the patients' interpretation of the information 36,40,42 as well as a need for elaboration of the attributes and indicators by which balanced information can be more fully assessed.…”

“…Twelve articles provided background describing the definition or rationale related to presenting balanced information about options (Table 2). 7,21,25–35 Eight articles were experimental studies evaluating the balance or bias in the information presentation (Table 3), 36–43 and 42 articles quantitatively reported the views of patients, family, carers, and health care professionals who rated the patient decision aid as a balanced presentation (Table 4). 29,44–82…”