The design of behavioural interventions labelled as patient‐mediated: A scoping review

Abstract Objective Patient‐mediated interventions (PMIs) directed at patients and/or physicians improve patient or provider behaviour and patient outcomes. However, what constitutes a PMI is not clear. This study described interventions explicitly labelled as “patient‐mediated” in primary research. Methods MEDLINE, EMBASE, Allied and Complementary Medicine, PsychINFO, HealthSTAR, Social Work Abstracts, CINAHL and Cochrane Library were searched from inception on 1 January 2017 for English language studies that developed or evaluated behavioural interventions referred to as “patient‐mediated” or “patient mediated” in the full text. Screening and data extraction were independently duplicated. Data were extracted and summarized on study and intervention characteristics. Interventions were categorized as 1 of 4 PMI pathways. Results Eight studies (4 randomized controlled trials, 1 observational study and 3 qualitative studies) were included. No studies explicitly defined PMI, and few PMIs were described in terms of content and format. Although 3 studies employed physician interventions, only patient interventions were considered PMIs. One study achieved positive improvement in patient behaviour. Conclusions Research is needed to generate consensus on the PMI concept, employ theory when designing or evaluating PMIs, establish the effectiveness of different types of PMIs, and understand when and how to employ PMIs alone or combined with other interventions.


| BACKGROUND
Engaging patients, which includes consumers, the public, family members or care partners, in their own care and in planning or evaluating health service delivery improves patient outcomes and lowers costs. 1 Hence, patients are key health-care stakeholders and central to health-care quality improvement. Yet implementation research, the study of behavioural determinants and interventions that optimize health-care quality, has largely focused on health-care professionals. 2,3 The paucity of research on "patient-mediated interventions" (PMIs) is notable-interventions targeting patients can have moderate to large effects on health-care delivery and associated outcomes, 4 and some research suggests that interventions aimed at both patients and providers may be more effective than targeting one group alone. 5 A recent editorial on topics of relevance to the field of implementation science highlighted a lack of clarity on what constitutes a PMI. 2 The Cochrane Effective Practice and Organisation of Care (EPOC) Review Group categorizes PMI as an implementation strategy targeted at health-care professionals and defines a PMI as "the use of patients, for example, by providing patient outcomes, to change professional practice." 6 The definition does not specify if patients themselves report outcomes to health-care professionals or data about patient outcomes are provided by others to healthcare professionals, a mechanism that also underlies other EPOC implementation strategies targeting health-care professionals including audit and feedback, clinical incident reporting, educational outreach, public release of performance data and routine patientreported outcome measures. Researchers have more expansively defined PMIs as "any intervention aimed at changing the performance of health-care professionals through interaction with patients, or information provided by or to patients." 5 In this definition, patients either report outcomes to health-care professionals or first receive information that presumably influences their interaction with and/or the behaviour of health-care professionals. The Expert Recommendations for Implementing Change (ERIC) checklist of 73 implementation strategies does not include a category labelled as PMI, but does include interventions in which patients receive information, which are labelled as educational meetings, involve patients and family members, prepare patients to be active participants and mass media. 7 Checklists of behavioural interventions (EPOC, ERIC) differ in whether and how they recognize and define PMIs, 6,7 leaving researchers who wish to evaluate PMIs to devise their own broad definitions, 5 and offering no clear guidance to health-care professionals responsible for quality improvement for what constitutes a PMI.
While patient education was acknowledged as a strategy for improving health-care delivery and outcomes at least as far back as 1977, 8  terventions. The review found that providing patients with information and education and providing physicians with patient information were both effective techniques in altering physician performance and patient outcomes. Subsequently, the term "patient-mediated" was used in 2 systematic reviews that both assessed the effectiveness of interventions for changing physician behaviour. A systematic review by Oxman et al of 102 trials published from 1970 to 1993 explicitly defined PMI as "any intervention aimed at changing the performance of health-care providers for which information was sought from or given directly to patients by others (ie, direct mailing to patients, patient counselling delivered by others or clinical information collected directly from patients and given to the provider)." 10  Our review of the original conceptualization of PMI by Oxman 10 and Davis,9,11 and then others, 5 reveals 4 different pathways that may all mediate or influence a variety of patient outcomes: patient strategies (ie, information, education, reminders) that directly influence patient behaviour or indirectly influence health-care professional behaviour, and health-care professional strategies (ie, patients directly report outcomes to physicians, others report patient outcomes to physicians, physician education) that directly influence health-care professional behaviour or indirectly influence patient behaviour. A depiction of the 4 PMI pathways is shown in Figure 1. This preliminary conceptual framework would benefit from further elaboration of the 4

| Approach
The overall aim of this research was to describe the characteristics of primary studies that investigated interventions explicitly labelled as PMIs rather than evaluating outcomes or determinants of those outcomes as a means of assessing the effectiveness of PMIs as would a traditional systematic review. A protocol for a Cochrane systematic review has been registered to investigate whether and how PMIs improve professional practice. 12 Interventions of interest outlined in the protocol include patient information, education, decision aids and membership on committees; information collected from patients given to health-care professionals; and education of health-care professionals by patients. 12 These interventions correspond to pathways 2 and 4 in Figure 1, which focus solely on changing physician behaviour as a means of influencing patient outcomes. Instead, a scoping review was conducted to describe the nature of research on PMIs according to the broader conceptualization of PMIs informed by prior research 9-11 and depicted in Figure 1 and to identify issues not addressed that warrant further research. The scoping review included searching, screening, data extraction and data analysis. 13 Preliminary exploratory searching, typically the first step, was not needed because the review sought only studies that explicitly employed the term "patient-mediated" or "patient mediated." 13 While not typical of a scoping review, data on outcomes and determinants (enablers, barriers) of those outcomes were extracted, if available, to thoroughly convey the characteristics of research on interventions explicitly labelled as PMIs. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) criteria guided reporting of the methods and findings. 14 Data were publicly available so institutional review board approval was not necessary. A protocol for this review was not registered.

| Searching
Several databases were searched on 1 January 2017 from their inception for English language studies that described identify studies that explicitly referred to PMIs, the search strategy searched for the terms "patient mediated" or "patient-mediated" anywhere in the full text of articles.

| Eligibility criteria
The eligibility criteria used to screen search results were based on the PICO (population, intervention, comparisons, outcomes) framework.

| Screening
Titles and abstracts were screened independently by JYN and ARG.
All items selected by at least one reviewer were retrieved for further assessment. If more than one publication described a single study and each presented the same data, the most recent was included.

| Data extraction
A data extraction form was developed to collect information on au-

| Data analysis
Summary statistics were used to describe the number of studies by year published, country, health-care topic and research design, and the number that used theory, single or multifaceted interventions and explicitly defined PMI. Given the sparse and succinct nature of extracted data on PMIs, qualitative content analysis was not possible. Instead, details about intervention characteristics were summarized using text according to where and how PMI was described in the article, target of the intervention (patient, physician), the type of intervention developed or evaluated and intervention impact. Based on a summary of intervention target, intervention and impact, the PMI pathway of interventions developed or evaluated in each study was categorized as 1 of 4 PMI pathways depicted in Figure 1. Given that only half of the included studies reported sparse data on enablers or barriers, detailed analysis using a framework specifying determinants of the adoption of innovations was not performed. The quality of individual studies was not assessed because that is not customary for a scoping review. 13

| Search results
Searches retrieved 215 items in total of which 108 were unique. Title and abstract screening eliminated 96 items. Of the 12 full-text articles retrieved, 4 were excluded (2 due to publication type and 2 assessed general attitudes about patient engagement). A total of 8 studies were included in the review ( Figure 2). Table 1 summarizes data extracted from included studies. [16][17][18][19][20][21][22][23] Studies were published from 2002 to 2015 in Australia (2)  General practitioners received information about the project and received 3 times the normal consultation fee; they were invited to an educational meeting about the treatment of frequent attenders. All general practitioners received a summary of discussions at educational meetings, and a contact list for included patients from their practice. Following an after-hours contact, patients received an invitation to contact their general practitioner for a consultation. Delivery NR Timing Physicians received patient lists monthly. Patients were contacted 2-5 d following an after-hours contact. Participants Patients who had 5 or more contacts during preceding 12 mo in 83 intervention and 93 control practices and physicians in those practices Personnel NR Outcomes Main outcome measure was decrease in after-hours contacts.

| Study characteristics
Outcomes were reported for 3500 intervention and 4635 control patients from 83 intervention and 93 control practices. The number of contacts was fewer in the intervention group but significantly different only after 12 mo and for women aged 17-66 y with 5-9 contacts in the previous 12 mo. There were no significant differences between intervention and control patients for secondary outcomes (contacts with physicians, hospital admissions, visits to outpatient clinics  In all studies, the intervention under development or evaluated was targeted to patients, although one study did not specify if interventions targeted to physicians were also considered part of the PMI strategy. 23 The patient interventions implemented in one study were not reported. 17 In other studies, the patient intervention was most frequently educational material (ie, booklets, question prompt lists, evidence summaries) 16,[18][19][20][21]23 and, in one study, an invitation to contact their physician for an appointment. 22 Three studies employed multifaceted strategies in which one or more components were targeted at physicians. In two of these studies, the physician interventions were not considered PMIs and consisted of audit and feedback, educational outreach and educational material in one study, 17 and educational material and an educational meeting in the second study. 22 In the third study that employed a physiciantargeted intervention, it was not specified if the physician intervention, comprised of educational material, invitation to an educational meeting and reminders, was considered as part of the PMI. 23

| Intervention impact
Details about intervention impact are summarized in Table 1. Of 5 studies that evaluated behavioural or clinical outcomes, there was no significant difference before and after intervention delivery or in comparison with control groups in 4 studies, 16,17,19,22 2 of which included both patient and physician interventions although physician interventions were not considered PMIs. 17,22 In the fifth study, in which it was not clear if physician interventions were also considered part of the PMI, intervention patients with low back pain returned to work significantly earlier compared with control patients. 23 Four studies assessed facilitators or barriers of PMIs through qualitative interviews or focus groups with patients. In 2 studies, patients said that an educational booklet alone was useful but interaction with health-care professionals was also needed. 16,21 In another study of T A B L E 2 (Continued) evidence summaries and question prompts, patients varied in views about their relevance and usefulness, and few said that it prompted them to ask questions. 18 In another study of an educational booklet, patients said they appreciated information on self-management and its positive tone, unambiguous guidance, visual appeal and small, por-  Table 2 summarizes the intervention target, intervention and impact and, based on those details, categorizes the intervention addressed in each study according to PMI pathways depicted in Figure 1. For example, in one study, educational material was targeted at patients and its impact was evaluated based on patient-reported behaviour. 16 According to Figure 1, this corresponds to PMI pathway 1. Seven studies were based on PMI pathway 1 in which patient strategies are meant to influence patient behaviour leading to improved patient outcomes, 16,[18][19][20][21][22][23] although in one study, it was unclear whether physician interventions were also considered part of the PMI. 23 One study was based on PMI pathway 2 in which patient strategies are meant to influence health-care professional behaviour leading either directly to improved patient outcomes, or indirectly to improved patient outcomes by influencing patient behaviour. 17 No studies explicitly involved interventions reflecting pathway 3 in which physician strategies are meant to influence patient behaviour leading to improved patient outcomes-although 3 studies included physician strategies, 2 did not refer to the physician interventions as PMI 17,22 and, in one, it was not clear. 23 No studies were based on PMI pathway 4 in which physician strategies are meant to directly influence physician behaviour leading directly to improved patient outcomes, or indirectly to improved patient outcomes by influencing patient behaviour.

| DISCUSSION
This scoping review described the characteristics of primary research on interventions that were explicitly labelled as "patient-mediated" or "patient mediated" and compared the interventions to original conceptualizations of PMI that proposed at least 4 pathways (Figure 1). [9][10][11] Following publications by Oxman 10   In all studies that described patient interventions, the intervention was educational material, which achieved positive impact in only one of those studies. 23 Patient educational material is inconsistently effective, and many other types of interventions are available to inform, educate and activate patients. 28,29 Future research should establish which types of patient interventions are most effective in different contexts. For example, patient-reported outcomes could serve as the basis for designing PMIs, 30 and various types of communication and decision aids can improve patient outcomes. 31,32 Three studies also employed educational interventions targeted to physicians, although they were not explicitly considered part of the PMI, 17,22,23 of which only one achieved a positive impact. 23 A meta-review of 25 systematic reviews that compared direct and indirect effect size and doseresponse of single and multifaceted strategies showed no benefit of multifaceted over single strategies. 33 Yet other research showed that educational interventions aimed at both patients and providers may be more effective than targeting one group alone. 5 Ongoing research should resolve this discrepancy regarding the number and type of PMI interventions needed to improve health-care delivery and associated patient outcomes.
This study featured both strengths and limitations. In contrast to other reviews that included primary studies in which behavioural interventions were considered by review authors to be PMIs, 24