Patient experiences in retinal trials: a cross-sectional study

Increasingly, participant experience studies are undertaken as part of clinical trials to improve recruitment, as well as the delivery and conduct of future trials [30]. Most of these studies, not in the field of ophthalmology, have focused on patients’ understandings and experiences and how these might influence recruitment, retention and adherence to the investigated intervention [31‐34]. Ophthalmology patient satisfaction studies have mainly been in the areas of cataract and refractive surgeries [8‐11], as well as in for oculoplastics and glaucoma surgeries [12, 35]. Our study provides insight into patient experiences and satisfaction in clinical trials in the context of translational retinal research.

In this study we surveyed 80 consecutive patients participating in various clinical trials for retinal diseases. We found that participants generally found their experience in retinal clinical trials to be positive and satisfying. These findings are reassuringly consistent with other studies of patient satisfaction within the clinical trial environment in ophthalmology as well as other fields of medicine [9, 13‐15, 32, 33].

Recruiting and maintaining participants in clinical trials is vital and often challenging. In order to achieve good trial recruitment and retention, an understanding of what makes the experience satisfactory for the patient is likely to be helpful. To address this need, our study investigated the reasons for trial participation, expectations and measures of satisfaction. In a study including inpatients and outpatients after cataract surgery from three facilities, Nijkamp et al. found that satisfaction with regard to the quality of care, judgments about the counseling, and meeting patients’ preoperative expectation concerning the medical outcome were predictors of overall patient satisfaction [14]. Predictors were consistent among the investigated settings and overall satisfaction scores also did not significantly differ. Jackson et al. also reported that understanding and meeting initial expectations is an important component of achieving a satisfactory patient experience in a general medicine walk-in clinic [36].

We examined the decision making process to enter clinical trials of retinal disease in terms of patient understanding and reasoning. We found that the primary source of trial information came from medical staff, with the majority of patients (96 %) feeling that adequate information had been given to them. This emphasises that ophthalmologists and other clinical staff have an important role to increase patient participation in trials, since they are by far the primary source of information about the study. However, most patients rated themselves as the most important factor in making the decision, with the decision usually made within 24 h; this emphasizes that recruitment in clinical trials should be patient-focussed with the amount and level of information geared appropriately towards patients.

It is noted that 14 % of patients did not feel they could withdraw from the study. This is an inaccurate perception which demonstrates the potential for misunderstanding in the consent process, possibly resulting from language barriers and the use of lengthy consent documentation. Participants might have been more focused on the actual treatment and side effects or visit scheduling information and the decision making of whether to enter a clinical trial, and less on other issues such as withdrawing. The conduct of verbal consent, the conduct of the survey on site, and the signing of the consent for retinal studies all in one day may all be unintentional subtle sources of undue influence. Nevertheless, this highlights the importance of clearly explaining to patients their rights when entering the study as well as their obligations, and not ‘flooding’ patients with too much information simultaneously.

We found that there were both strong altruistic and self-motivated reasons behind patients’ decision to participate in trials. The most popular responses as to why they participated in a clinical trial were ‘to assist medical science’ and ‘to have (their) condition more closely monitored’. These findings were corroborated by measures for patient satisfaction, with the most common benefit described by patients as increased knowledge of their particular medical condition. Other popular responses were free medical care and services and increased contact with the treating team.

Consistent with other studies, there appears to be a desire amongst a significant proportion of patients to feel actively involved in their care, expressed by a desire for greater knowledge and greater contact with staff [37]. This increased involvement can lead to improved patient outcomes as well as satisfaction. It is acknowledged that those who had volunteered for trials were more likely to have this desire for participation. In terms of advocating trial involvement, it can be seen from our study that those who joined largely described a desire for a greater sense of knowledge, involvement and frequency of care, and that expectations were largely satisfied through the trial process.

Another aspect of assessing participant satisfaction was the patient response to services and caregivers. We found that the vast majority of patients within the retinal research clinics studies were very satisfied with services and staff, with 74 % rating them as ‘excellent’. Previous studies have consistently demonstrated the importance of communication between patients and their caregivers and the value of providing relevant information such as regarding operative processes or diagnostic tests [16, 38‐43]. Our study corroborated these findings, with patient interaction with staff likely playing an important role in achieving overall high satisfaction. The impact of study participation on relationship with staff was also demonstrated by the fact that 58 % of patients thought their relationship with their doctors improved through participating in the clinical trial. Further qualitative research may be warranted to elucidate the specific important aspects of this relationship with patients. A qualitative study using focus groups by Dawn et al. identified 6 areas of expectations for eye care that were important to patients: honesty, information about diagnosis and prognosis, explanation in clear language, ophthalmologists’ experience and reputation, empathy and listening and addressing concerns [19].

We also sought to identify areas of dissatisfaction in order to understand if these could be addressed to improve the patient experience and whether these elements of dissatisfaction were related to the trial experience. The main problem identified was prolonged wait time in the clinic, transport and parking problems. Communication and information provision to health consumers, especially in relation to waiting times, have been shown to have positive effects on satisfaction levels, resulting in significant falls in complaint levels [44]. A discussion and briefing regarding wait times is indeed performed with patients in the clinics studied. While wait times remain a source of discontent, it is possible that the communication that takes place around these times mitigates their impact on overall patient satisfaction, reflected in the fact that 93 % of patients remained willing to return to the public outpatient clinics at the conclusion of the study. Further, patients did not feel their time was being generally wasted, as three-quarters of them did not think there were too many follow up visits or that there were too many forms to complete. The latter may be because data collection was predominantly performed by study staff rather than patients. There were very few studies that asked patients to complete forms.

Access to the clinic was a major cause of patient dissatisfaction. Since the hospital is a quaternary referral service, as is likely to be the case for other centres where clinical trials of retinal disease are performed, patients usually were not travelling from the immediate locality. Sponsored clinical trials would have the means to provide adequate reimbursement for travel and parking to the investigational site, but this may not be feasible for investigator initiated trials.

The major limitations of this study are those inherent in cross-sectional, ‘self-reporting’ questionnaire surveys. Patients who are more satisfied with care are less likely to return questionnaires, thus potentially under-estimating satisfaction levels [45]. Despite this, the response rate of our survey was high at 96 %, with those few declining mainly citing language difficulties. Nevertheless, we could not assess the differences in baseline or clinical characteristics between the responders and non-responders. Furthermore, there was the potential undue influence of patients being handed the survey by research staff and the expectation to complete it on site. A lower response rate might have been attained if the survey was not allowed to be completed on site, however this approach would cause greater inconvenience to patients and would yield a much lower response rate. Another limitation of this study was that the distribution of patients across the 14 retinal trials was not known, as we did not collect this information from the questionnaire. We confirmed that they were from at least one of the listed studies only. Our population was a consecutive sample and included patients from a number of different trials. Our clinics are not differentiated based on which clinical trials the patients are part of.

Tendency for respondents to bias towards positive responses and use acquiescent replies was minimized by adopting positively or negatively worded, specific questions [25, 46, 47]. However, one question was constructed with a positive bias: “How did you benefit from participating in the study?” This question did not offer a neutral or negative response option, and thus it was unsurprising that a high majority of respondents described this study as beneficial. This could have been avoided if a more vigorous question selection process had been undertaken, that would include multiple pilot tests, focus groups and interviews to enhance content validity [48, 49]. Other questions appropriately included the full range of response options. In addition, while the specific and limited range of responses allowable assisted in giving a good overview of quantifiable data, further qualitative research would likely be of benefit to explore further patient views and level of understanding. It is conceded that if we had studied patients who were approached for participation in clinical trials rather than those who had already consented to join, we may well have found different responses to some questions.