Factors that influence patient and public adverse drug reaction reporting: a systematic review using the theoretical domains framework

Search outcomes

Twenty-six articles met the inclusion criteria [14, 29, 33, 44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66]. Figure 1 presents the PRISMA flow diagram. See electronic Supplementary File A, which provides further detail of study exclusion following full-text review. All studies were of cross-sectional design, adopting either qualitative (n = 7) or quantitative methods (n = 13); six articles adopted mixed methods. None of the studies had adopted relevant theories to support their investigations. Details of excluded studies with reasons of exclusion in electronic Supplementary File B.

Fig. 1figure 1

PRISMA flow diagram for selected articles

Study characteristics

Studies were published between 2008 and 2021, and were conducted in a range of countries; Saudi Arabia (n = 3) [49, 55, 57], United Kingdom (n = 4) [44, 58, 63, 64], USA (n = 2) [52, 53], Ghana (n = 3) [29, 48, 66] with remaining studies from South Korea [33], Netherlands [50, 62], Thailand [47], Canada [49], and Australia [14, 45, 59]. Detailed study characteristics are presented in Table 1.

Table 1 Description of included articles

Four studies conducted in the UK investigated patients and public’ perceptions of the National Yellow Card Scheme (YCS) [44, 58, 63, 64]. Similarly, further studies, included investigations of national reporting systems and provided a description of the reporting system and the process for patient and public reporting, however, there were 7 studies in which such details were excluded or minimally reported [45, 47, 49, 54, 57, 59, 65].

There was also considerable diversity in the number of participants involved in the included studies, cross-sectional quantitative studies ranged between 84 and 2484 participants; qualitative studies ranged between 15 and 78 participants. Participants included in the studies were either members of the public, patients who had experienced ADRs previously (buy not necessarily reported it), or participants who were retrospectively approached following submission of their ADR through an ADR reporting system. Further detail of the ADR reporting systems and study participants are presented in electronic Supplementary File C.

Risk of bias assessment

Risk of bias using the JBI checklist indicated that the influence of the researchers on the methodology in qualitative studies was not always reported [58, 64]. Within cross-sectional quantitative studies, reporting the assessment of confounding factors was frequently absent [48, 49, 54]. Assessment of mixed-methods studies using the MMAT tool revealed that the majority of studies were of high quality; however, one study did not perform sample size calculations, which drew some concerns regarding the external validity and generalizability of data [44]. Risk of bias results for both JBI and MMT tool represented in electronic Supplementary file D.

Coding of factors influencing patients and public ADR reporting

A total of twelve TDF domains resonated from factors reported in the included articles. Examples of each domain are represented in Tables 2 and 3. The TDF domains memory, attention and decision processes and behavioral regulations did not seem to be implicated in patient and public reporting of ADRs.

Table 2 TDF domains: behavioral factors towards ADR reportingTable 3 The distribution of TDF themes generated through included articles

Knowledge: Four studies reported factors that were mapped to knowledge; patients and public often lacked adequate understanding and knowledge about ADR self-reporting systems and the purpose of these systems. Studies were cross-sectional quantitative and qualitative that indicated patients and the public were aware of the available ADR reporting systems and the process for reporting, which subsequently encouraged reporting [52, 54, 58, 66].

Skills: One UK study preformed a cross-sectional qualitative methodology and concluded that patients who had acquired skills in reporting ADRs (either under the direction of a healthcare professional or an informed acquaintance) and had prior knowledge of how to use the Yellow Card Scheme seemed to be more motivated to submit ADR self-reports [58].

Social /professional role and identity: Seven studies reported factors influencing ADR reporting, as per our analysis, these factors were mapped to social/professional role and identity. Some studies indicated patients and the public belief that they themselves have an important role to report ADRs, and a responsibility to prevent harm and help support drug safety research [50, 52, 58, 62]. In contrast, four studies mentioned an opposing perception; patients and the public did not believe that ADR reporting is their responsibility, rather it is the healthcare providers’ duty [33, 57, 61, 62].

Beliefs about capabilities: There were conflicting reports regarding patients and the public belief in their ability to report ADRs; two studies reported positive beliefs [33, 46]; whereas, one study described that an important factor contributing to patient under-reporting was a self-perceived lack of necessary skill and inability to accurately identify ADRs [58].

Optimism: From four studies, our analysis mapped factors to optimism. Patients and the public were optimistic that their reports would help enhance drug safety and improve health systems [29, 44, 58]. Whereas one study indicated patients’ lack of optimism and belief that their reports would have no subsequent impact [33].

Beliefs about consequences: In six studies, participants indicated that they report ADRs because they recognize their importance in preventing harm and potential to positively impact on their lives [44,45,46, 62, 65, 66]. Additionally, patients and the public believed that their reports provide more information that contribute to improved medication safety [29, 47, 58, 66]. However, only three studies reported that patients and the public may avoid ADR reporting due to previous negative experiences such as dismissal, denial, and lack of feedback from the ADR reporting system [33, 56, 60].

Reinforcements: Three studies reported other stimuli that encouraged patient and public reporting, these included intolerable and severe drug reactions that impact daily living, and if patients and the public perceived the need for additional medical care to resolve the drug reaction [56, 60, 63].

Intentions: One study reported patients’ intention to report so to have a voice in sharing their concerns directly with the ADR reporting agency, without interference from healthcare professionals [58].

Goals: Two studies indicated that patient aim to provide information about ADRs that are not mentioned in the patient leaflets; therefore, they tend to report their ADRs whenever it occurs [29, 50].

Environmental context and resources: Three studies mentioned that when patients and the public received specific directions and reminders from healthcare providers, they were more motivated to report their suspected ADR [49, 55, 58]. Based on the analysis, these factors were mapped to environmental context and resources. However, practitioners’ dismissive attitudes; the cost of accessing the ADR reporting system; were environmental factors that discouraged patients and the public from reporting [44, 58, 60]. Additionally, one study mentioned that having an ADR system that is easily and freely accessible and not limited to clinic-opening times was preferred [55]. Participants across various investigations agreed that a system that was easily and freely accessible, that was not limited to clinic-opening times was preferred [47, 48, 54]. Two studies reported that the use of technology such as mobile phones or web-based platforms were more preferred than paper-reports with an integrated function to provide feedback following submissions of reports [47, 48].

Social influences: Patient self-reporting was encouraged by family members and healthcare providers [29, 56].

Emotion: Two studies revealed that patients and the public anxiety resulting from suffering an ADRs is what encouraged them to report [50, 53]. Moreover, patients and the public annoyance and dissatisfaction with practitioners’ response; motivated them to report [46, 58]. In contrast, one article mentioned that patients indicated feeling embarrassed to report specific ADRs may have prevented them from reporting [51].

留言 (0)

沒有登入
gif