Background
The concept of participant experience
What are the potential benefits of patient experience measurement?
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Identify studies (involving any type of participant, intervention, comparison or outcomes) using a standardised measure of patient experience of trial participation.
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Characterise the measures in terms of purpose, format and aspects of participant experience that were assessed.
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Report existing findings on patient experience within the identified studies.
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Make recommendations for future development and application of participant experience measurement.
Method
Searches
Information sources
Study inclusion and exclusion criteria
Data charting and synthesis
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Trial context (type of trial, date run, and location of sites) and population (age, gender and condition)
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Participant experience measure, which included the measure name, type (report and evaluation), administration (interviewer and self-report), and the aspects of patient experience measured
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Summary of results reported
Results
Study | Geographical location(s) | Number of trials or facilities in the study | Delivery and administration | Items | Participants surveyed (response rate) | Domains |
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Almeida et al. (2007) [22] | Portugal | 1 facility | Self-report In person Before discharge from the study | 14 | 136 (100%) | i) Motivations for taking part ii) Perception of informed consent iii) Perception of study participation |
Aman et al. (1995) [23] | Not reported | 2 trials | Self-report Postal 4 weeks after enrolment | 6 | 63 (63.5%) | i) Staff characteristics ii) Study operations iii) Specific features of trial iv) Incentives and reinforcements |
Bahati et al. (2010) [24] | East Africa | 3 facilities | Interviewer Not reported Study end | Not reported | Not reported (98%) | i) Satisfaction with service received ii) Satisfaction with major components of the research study |
Bertoli et al. (2007) [25] | Argentina | 3 trials | Self-report Postal Not reported | 34 | 114 (94.6%) | i) Socio-demographics ii) Overall trial satisfaction iii) Quality of information given by the Investigator iv) Participants’ self-perception of knowledge about randomised controlled trials (RCTs) v) Objective evaluation of participants’ knowledge about RCTs |
Bevan et al. (1993) [26] | UK | 1 trial | Interviewer In person Not reported | Not reported | 199 (99%) | i) Reasons for participation or declining participation ii) Aspects of trials disliked |
Cain et al. (2005) [27] | UK and Republic of Ireland | Self-report Postal Study end | 23 | 44 (82%) | i) Information provided ii) Reasons for taking part iii) Best and worst aspects of participation iv) Willingness to participate in the future | |
Dias et al. (2005) [28] | Not reported | 1 trial | Self-report Postal 3.5 year follow-up | 19 | 469 (88%) | i) Staff characteristics ii) Study operations iii) Specific features of trial iv) Incentives and reinforcements |
Fearn et al. (2010) [29] | UK | 1 trial | Self-report Postal Study end | Not reported | 910 (59%) | i) Motivations for taking part ii) Health professional involvement iii) Randomisation iv) Filling in questionnaires v) Experience of participation |
Friesen et al. (2016) [30] | USA | 1 trial | Self-report In person At final clinic appointment | 47 | 180 (98%) | i) Attitudes towards trials ii) Working with study team iii) Perception of risk benefit iv) General satisfaction |
Van Gelderen, et al. (1993) [31] | The Netherlands | 10 trials | Self-report Combination of postal, taken home and at end of trial Study end | 12 | 153 (94%) | i) Reason for participation ii) Information received iii) Most unpleasant aspects iv) Most pleasant aspects v) Experience of participation |
Hassar et al. (1976) [32] | USA | 1 trial | Interviewer Not reported Study end | 12 | 1503 (80%) | i) Reasons for investigators taking part ii) Participant impression of clinical studies iii) Medical practice in general |
Henzlova et al. (1994) [33] | USA and Canada | 1 trial | Self-report Not reported Before close out visit | 10 | 4751 (74%) | i) Primary motivation for participation ii) Satisfaction with participation and perceived outcome iii) Effect on health-conscious behaviour iv) Negative experiences |
USA | 29 facilities | Self-report Not reported Study end | 76 | 18,890 (29% of participants surveyed) | i) Informed consent ii) Trust iii) Coordination of care iv) Information, education and communication v) Respect for participant preferences | |
Luzurier et al. (2015) [36] | France | 1 trial | Self-report Not reported Not reported | Not reported | 210 (% not reported) | i) Satisfaction (with overall welcome and protocol management) ii) Motivation for taking part iii) Participation outlook |
Martin et al. (2011) [37] | USA | 3 trials | Self-report Postal Not reported | 47 | 75 (89%) | i) Understanding of participation ii) Reasons for participating iii) General experience iv) Overall satisfaction v) Willingness to participate in a future study including a placebo-controlled trial |
McAdam et al. (2002) [38] | Not reported | 1 trial | Not reported Not reported Not reported | 7 | 21 (81%) | i) Information provided ii) Staff iii) Research processes iv) Research outcomes v) Willingness to participate in the future |
Mattson et al. (1985) [39] | USA | 1 trial | Self-report/Interview Postal Before final follow-up | 5 | 1503 (80%) | i) Perceived benefits ii) Perceived beneficiaries iii) Perceived disadvantages iv) Perceived effects of medication v) Participation in a future trial |
Renfroe et al. (2002) [40] | USA and Canada | 1 trial | Self-report Postal Study end | 7 | 664 (71%) | i) Would participate again ii) Main reasons for participation iii) Study benefits iv) Study problems v) Quality of care. |
Schron et al. (1997) [41] | USA | 1 trial | Self-report Postal Final follow-up (4.5 years after enrolment) | 10 | 4281 (82%) | i) Reason for participating ii) Satisfaction with participating |
Tangrea et al. (1992) [42] | USA | 1 trial | Self-report Postal Study end | 7 | 891 (97%) | i) Benefits ii) Most unpleasant aspects iii) Importance iv) Satisfaction v) Physical well-being vi) Willingness to take active treatment if shown to be effective vii) Participation in future trials |
Verheggen et al. (1998) [43] | The Netherlands | 26 trials | Personal interview (at start of the trial) Telephone interview (3 months later) | Not reported | Personal interview = 172 (93%); Telephone interview = 172 (78.5%); control group (only participating in telephone interview) = 34 (100%) | i) Medical technical aspects ii) Interpersonal iii) Organisational aspects |
Trial context
Types of measures within the trials
Defining participant experience and measure development
Format, mode of delivery and time points
Participants
Domains assessed
Results of the patient experience measures
Discussion
Summary of results
Limitations of the studies
Strengths and limitations of the review
Implications
Practical issues concerning the collection of patient experience data
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What are the core dimensions of a ‘patient-centred’ trial that should be included in a participant experience measure? Table 2 highlights variation in what aspects of patient experience are measured in different studies and suggests that global experience, specific aspects of the trial (such as informed consent) and positive and negative aspects of participation are most likely to be measured. It is not clear which aspects are most important to patients or other stakeholders (such as trial teams and funders) or how evaluations of the different aspects are associated, as they may reflect a global assessment. Effective priority-setting methods such as those used in previous assessments of patient priorities around trials may be useful in this regard [48]. It will be important to identify the generic questions of relevance to all trials and others that may be important for particular trials or in particular contexts. A modular approach to measurement (with generic and trial-specific measures) may be optimal.
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What are the optimum format and delivery mode of patient experience measures? Further work is required to understand the optimum way in which to collect experience data. All of the studies found in our review measured evaluations rather than reports, although it is unclear why that is the case. Most studies evaluated experience at the end of the study, which allows a more comprehensive assessment of the entire experience of participation but raises issues concerning the ability of participants to recall earlier aspects of the trial.
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What is the correct balance between quantitative and qualitative approaches to measuring patient experience? Clearly, there is a significant qualitative literature on patient experience in trials [16, 49] and it will be important to explore the optimal methods by which they can complement each other to take advantage of their relative strengths.
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How can developments in technology facilitate measurement? Developments in technology may improve the collection of patient experience data in the future. For example, digital recording of patient narratives might be analysed by using text mining to allow efficient capture of data that is richer than standardised measures.
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Should measurement of patient experience be independent of the trial team? Independence may better avoid bias and the perception of pressure but that may not be feasible in the context of limited resources available to trial teams. The impact of such independence on assessments could be assessed by using the Study-Within-A-Trial design [50].
Issues in the interpretation of patient experience data
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It is important to understand what influences patient experience and how much of the variation in experience is due to context and trial type, patient characteristics, or aspects of the trial. There is an ongoing debate as to whether adjusting for such factors is a fairer way of assessing performance or whether such adjustment removes the imperative to improve care [51].
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In terms of factors related to the trial itself, it will be important to determine how much of the variation in patient experience is due to specific processes (how patients are approached, how consent is gained, and preferences considered) [52] compared with the general interpersonal and communication skills of staff [53]. Effective ‘closure’ in trials (thanking patients for participation and providing results) may be as important as their experience in the trial itself [54].
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Another methodological issue of interest is whether patients can distinguish between their experience of the interventions within a trial and their experience of the other trial procedures. Acceptability of interventions will often be assessed in pragmatic trials as part of a comprehensive assessment of the value of the intervention. Some aspects of patient experience may be beyond the control of the trial team (such as the result of their randomised allocation and the outcomes patients achieve from treatment).
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It will be important to explore the relative importance placed on the measurement of patient experience in different types of trials. For example, some trials have little active patient participation or even awareness of participation (such as cluster trials without individual consent), where a focus on patient experience may be less relevant.
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It will also be important to consider the costs and other disadvantages of a focus on patient experience in trials. There may be potential unintended consequences of measures of patient experience (such as causing trial teams to focus on aspects of experience that are easily measurable compared with more complex issues). Work in this area will also have to be aware of the wider literature on the concept of ‘satisfaction’ and its measurement [55‐57].
Recommendations for describing participant experience measurement
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Whether the measure was used to assess experience in one trial or across a trial portfolio.
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Trial context (trial phase, condition under investigation, and core features of intervention)
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Location where the trial or trials were conducted (country and facility where applicable)
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Development detail (e.g., how the items were selected, estimated completion times, and whether the measure has been subject to reliability and validity testing)
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Number of participants invited to complete the measure and response rate
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Percentage of participants who complete the measure who withdrew from the trial (failure to adhere to the protocol or provide routine follow-up data)
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Participant characteristics, including demographics (and other characteristics which may be relevant to specific trial/facility)
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Delivery mode (postal, face-to-face interview, telephone interview, and online) and administration time points
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Any incentives or tokens of thanks given to participants for completing the measure
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Number of items and response options (if the measure is not published as part of the article)
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Details for how the measure can be sourced (and languages available).