Quantitative analysisSociodemographic characteristics

Three quarters of participants were women, and 69% were aged under 65. Most respondents had a high level of education, with 36% having a bachelor’s degree as their highest qualification and 34% holding a postgraduate degree. Almost all participants (94%) reported that they use digital tools for healthcare activities (Table 1).

Table 1 Characteristics of the respondents and their experience with medicine use and digital tool use (N = 494)Consumers’ perception of the importance of the features of digital tools for ADR reporting

Ninety percent (n = 437/486) of respondents reported that it is important or very important for a digital ADR reporting tool to provide a free text space that allows consumers to describe ADRs in their own words. Similarly, 87% (n = 419/481) of respondents said that it was important or very important for a digital ADR reporting tool to acknowledge report submission (Fig. 1).

Fig. 1

Consumers' perception of the importance of features of digital tools for reporting ADRs

The views of consumers on the use of digital tools for reporting ADRs

Among the participants who responded to questions related to the C-TAM-TPB constructs, more than 80% agreed/strongly agreed with the statements regarding perceived usefulness, ease of use, attitude, behavioural intention and one of the two statements on perceived behavioural control (Fig. 2). For example, 82% (n = 400/491) agreed/strongly agreed that a digital tool for reporting ADRs would be useful, and 82% (n = 404/489) agreed/strongly agreed that it would likely allow for faster reporting compared to other methods (Fig. 2).

Fig. 2

Consumers’ views on the use of digital tools to report ADRs

Statistical difference between behavioural intention to use digital tools to report ADRs and respondent characteristics.

There were statistically significant differences in gender, experience of using digital tools for healthcare activities, and level of experience with smartphones between consumers who agreed/strongly agreed compared to those who strongly disagreed/disagreed/were neutral to the question relating to behavioural intention to use digital tools. More women (83%) than men (67%) (p < 0.001) agreed/strongly agreed about the future use of digital tools for ADR reporting. Similarly, respondents who used digital tools for healthcare activities (81%) agreed/strongly agreed compared to those who did not (58%) (p = 0.017). Furthermore, those with advanced smartphone experience (83%) agreed/strongly agreed than those with moderate (73%) or limited/no experience (47%) (p < 0.001) (Table 2).

Table 2 Characteristics of the respondents by intention to use digital tools to report ADRs in the future (N = 488)Ranking of ADR reporting methods

When provided a list of ADR reporting methods and asked to rank them in order of their preference of use, with the option to assign equal rankings, 49% (n = 227/468) of respondents reported that using a mobile app would be their preferred way to report ADRs and 38% (n = 177/468) reported that a website would be their most preferred way to report ADRs. Only 20% (n = 92/468) of respondents reported that their preferred method of ADR reporting was via a paper-based form, and 20% (n = 93/468) indicated a preference for reporting over the phone.

Chi-squared tests showed that there was a significant difference between consumers' age and their preferences for reporting ADRs. A higher proportion of consumers aged 18–44 years listed a website/web app as their first choice than consumers aged 45 years or older (p = 0.038, Table 3). A higher proportion of consumers aged 65 or older listed a phone conversation as their first choice compared to younger consumers (p = 0.015, Table 3).

Table 3 Respondents' preference of ADR reporting methods by their age (N = 467)Qualitative content analysis

Ninety-nine consumers provided free-text responses regarding what they want from digital tools for ADR reporting. Analysis of these responses generated 133 concepts resulting in 43 codes, which were subsequently categorised into nine categories based on their conceptual similarity. The categories were: accessibility, ease of use, provision of feedback, medicine safety information, provision of guidance and support for users, other digital tool functions, data privacy and security, reliability of report, and opinions on importance of digital tools. These categories were subsequently mapped into three themes of the TAM, including perceived ease of use, perceived usefulness, and attitude.

Perceived ease of use

Two categories were classified under perceived ease of use: accessibility and ease of use.

Accessibility

Five comments were made by respondents about the accessibility of digital tools for consumers. The respondents emphasized the need to be able to access digital tools on various platforms, as well as different operating systems to facilitate the process of reporting ADRs. Additionally, making it accessible to individuals with disabilities and implementing colours that are suitable for individuals with colour blindness.

“A digital tool needs to be clear and well set out. It also needs to be able to be accessed via computer and not just via a smartphone or tablet to assist those who need a bigger screen.”(P17)

Ease of use

Respondents made twelve comments regarding the ease of use of digital tools. They suggested making digital tools user-friendly, simple, easy to navigate, report without creating account, and usable for consumers with limited experience with technology. Respondents also wanted digital tools to use plain English, incorporating generic drug names and having a quick page load speed.

“I think this sounds like a wonderful idea, but it occurs to me that the UI [User Interface] would need to be super simple, just because there may be users who are not technologically savvy.”(P38)

Perceived usefulness

Four categories were classified under perceived usefulness: feedback, medicine safety information, providing guidance and support for users and other digital tool functions.

Feedback

Fourteen comments were provided by respondents suggesting that an acknowledgement of submission of their report and feedback on the progress of their report would enhance utilisation of digital tools to report ADRs.

“I would also like to receive some information about what will happen with my report, if I can expect a response.”(P43)

Medicine safety information

A total of thirty comments were received from consumers regarding the significance of obtaining medicine safety information through digital tools. Additionally, there was interest in linking digital tools to existing medication management applications.

“Enables me to obtain information, including possible side-effects, about the medication.”(P30)

Consumers said that they want a digital reporting tool that includes a feature allowing them to access information on previous ADR reports for medicines.

“Would be good to see the percentage of others who reported similar side effects.”(P98)

Providing guidance and support for users

Thirty-nine comments were made suggesting the importance of receiving advice on whether consumers need to consult their healthcare professionals (HCPs) or visit the emergency department and a feature that provides a reminder to consult HCPs.

“Gives advice on whether I should cease the medication and/or seek further advice from my doctor about the side effects.”(P33)

Consumers suggested that digital tools for ADR reporting should gather detailed information on how consumers handle their medicines, other chronic conditions, co-ingested food and drinks, supplements, as well as information on other medicines that were taken and the reason for taking them. Consumers emphasized the importance of obtaining contact information for HCPs and regulatory agencies that could assist them.

“Asking about how the medicine was handled (eg some people take the tablets out of the blister pack and put it into a plastic container divided into days. This may affect side effects?”(P21)

Other digital tool functions

Nine comments were made by consumers suggesting the addition of functionalities such as product scanning and photo uploading, keeping a record of submissions or emailing a copy to the individual making the report, the ability to report ADRs experienced by someone else, noise recording for breathing or type of cough, and the option to copy the report to a general practitioner to facilitate reporting of ADR using digital tools.

“Cc [carbon copy] to my G.P. [general practitioner] Too.”(P23)

“Scan the product upload a photo.”(P79)

Attitude

Three categories were classified under attitude: Data privacy and security, reliability of report and opinions on importance of digital tools.

Data privacy and security

Four comments were made on the importance of safeguarding the privacy and security of personal information when reporting ADRs. Consumers suggested the need for assurance regarding the handling of their information, e.g. receiving a code via mobile phone to log onto the site for security.

“I would like to know unequivocally that my privacy was not at risk.”(P46)

Reliability of reports

Nine comments were made on concerns with the reliability of ADR reports by consumers. They suggested that consumers should upload evidence of their medicine and ADRs, and digital tools should be equipped with features that prompt for corrections in the event of mistakes made during the reporting process. Respondents were also concerned about false reporting and over reporting with digital tools.

“I would be concerned that this feature could be used by some people to over report adverse reactions and affect the public perception of a particular medication.”(P42)

Opinions on importance of digital tools

Eleven comments were categorised under opinions on importance of digital tools. Participants highlighted that they feel it is important to have digital tools available to report ADRs, as they are likely to be convenient to use. They suggested using digital tools to report ADRs directly to regulatory agencies may help bypass HCPs if they are dismissive of a patients’ ADR concerns or who do not realise that a symptom reported by a patient may be an ADR.

“At times I have had my concerns about side effects dismissed by health professionals as not related to the medications or not significant enough to be concerned about, which may well be true. However having a place to describe them and be noted would be valuable as it is possible many people are having there [sic] concerns dismissed about the same medications and these effects are not being recorded.”(P19)

However, consumers also suggested involvement of HCPs during reporting is helpful to avoid errors.

“In the hands of genuine healthcare professionals, it would be helpful.”(P69)