Shoulder pain is a common musculoskeletal disorder.1 Within shoulder complaints, rotator cuff-related shoulder pain is the most common disorder and has slow recovery.2,3 Rotator cuff-related shoulder pain is defined as pain at the top and lateral part of the shoulder joint, that may spread to the neck and elbow, and is worsened by overhead activity.4 It is estimated that only 50% of patients presenting with new episode of rotator cuff-related shoulder pain fully recover within six months.5 Pending on treatment received (e.g., usual care or exercise therapy), recovery may take up to 12 months.3

Process evaluation studies help us to understand findings from clinical trials.6,7 The key components of process evaluation are contextual, implementation, and mechanism of impact.8 Contextual factors can inform theories of how the intervention works; and can affect or be affected by the implementation of interventions, their mechanisms, and outcomes. The implementation processes refer to how and what elements (e.g., fidelity, dose, adaptations to planned interventions, and reach) of an intervention is delivered.8,9 The mechanisms of impact refer to understand the causal pathways through which an intervention achieves its outcomes.8-10

Process evaluation studies should be conducted, ideally, at all stages of trials (from pilot or feasibility to implementation trials).8 When conducted alongside pilot or feasibility trials, these studies can inform researchers how to improve the design of the full trial.8-11 When conducted alongside the full trial or during implementation trials, process evaluation studies help stakeholders to understand whether an intervention tested was (in)effective due to its implementation during the trial or its design.8,9

Patients’ experiences within a trial can affect retention rates and treatment adherence.12 By understanding participants’ experiences during a feasibility trial, researchers can amend and improve the design of the full trial. Numerous aspects of a trial can influence participants’ experiences, including administrative-related factors (e.g., information sheet, consent forms, questionnaires), design-related factors (e.g., time required, burden).13 Their experiences within a trial can impact on retention rates as well as on treatment adherence.14 Poor treatment adherence may bias treatment effect estimates15,16 and one way to improve recruitment and adherence is to design trials that are aligned with patients’ needs and preferences.12-17 Given patients are one of the key stakeholders of clinical trials, their perspectives are relevant for researchers when planning and conducting clinical trials.18,19

In this paper, we expand the analyses reported in the MAnagement of Subacromial disorders of The shouldER (MASTER) feasibility trial.20 During the Otago MASTER trial, we recruited 28 participants who were randomly allocated into one of the following groups: (a) tailored exercise or (b) manual therapy and standardised exercise interventions. A total of 25 participants received interventions and completed all follow-ups. Interventions for both groups consisted of two sessions per week over eight weeks (i.e., 16 sessions in total). Each session lasted for approximately 45 min. We assessed the outcome measures at baseline and at 4, 8, and 12 weeks. One important characteristic of interventions planned for the MASTER trial was the high dose of interventions which does not reflect clinical practice in New Zealand.20,21 We have previously reported clinicians’ perceptions and treatment fidelity using a mixed-method process evaluation during the Otago MASTER feasibility trial.11 In this study, our aim was to explore participants’ perceptions of the trial interventions tested within the Otago MASTER feasibility trial.

We invited all 25 participants who took part in the feasibility trial. Nine participants informed us they were not interested in participating and sixteen participants agreed to take part in the interviews. The demographic information for those who participated in this study are presented in Table 1.

We identified three main themes: (1) motivations to volunteer; (2) perceived value, and (3) barriers and facilitators.

This qualitative study explored the perspectives of participants in a trial comparing a tailored intervention to a standardized strengthening programme. Our key findings suggest that participants: (1) took part in the study to access healthcare services and contribute to research; (2) valued interventions received; (3) reported certain barriers and facilitators to participate in the trial; and (4) highlighted areas for improvement when designing the full trial. As trialists, we need to be cognisant of the facilitators for participants and of the barriers, to enhance and mitigate these respectively, when planning the full trial.

Our findings suggest participants were motivated to take part in the trial due to access to healthcare (a service that they would not receive otherwise) and for a desire to give something back to the university or to research in general. These motivations are like those reported by patients with cardiovascular disease,28 who were interested in seeing the same clinician over time and keen to promote science. Contrary to our findings, those patients with cardiovascular disease rated access to free healthcare as least important and this may be due to the context of the healthcare system these participants came from. In New Zealand, patients who have chronic musculoskeletal pain (e.g., shoulder pain) have limited access to physical therapy services through the national healthcare system. In this study, we recruited participants from the community who were less likely to have easy access to appropriate healthcare.

Participants valued supervised sessions with a clinician and some participants reported those sessions increased their confidence and motivation to adhere to interventions (including home exercises). Participants reported developing self-management strategies and an increase in their self-efficacy behaviour. Self-efficacy is considered an important determinant of pain behaviour29 and was reported to be associated with better clinical outcomes in patients with shoulder pain.30 This study highlights the possible benefits of both interventions tested within the feasibility trial and seem to refute the idea that frequent sessions with a clinician would reduce self-efficacy, as participants reported feeling more confident to engage with exercises at home. Participants valued the empathetic environment. Through an empathetic relationship, clinicians can improve diagnostic accuracy, patient satisfaction, and their commitment to intervention requirements.31-34

Participants expressed interest and value in being informed about the mechanisms that caused their shoulder pain. Interestingly, these were not part of the planned intervention within the feasibility trial and some of those focused on neuromechanical causes for shoulder pain. Currently, it is unclear what causes shoulder pain and it is very challenging to identify the potential source of symptoms in this population.35,36 Clinicians clearly shared their clinical beliefs with participants and these influenced participants’ perceptions of the prescribed exercises. Some participants also expected a diagnosis and more detailed explanation regarding the cause of their pain, which is consistent with other studies.37

While participants reported barriers and facilitators to participating in the trial, (parking, health literacy level of materials, and ease of undertaking home exercises and scheduling sessions) these are all well discussed in the wider literature. Transport and commuting is known to be a barrier for patients to access to healthcare.38 Health literacy of an individual can have a negative impact on health behaviour and clinical outcomes (e.g., poor self-management skills, non-adherence to treatment, increased healthcare costs).39 In our study, it highlighted the need to further simplify the instructions used in documents prepared for participants. Some participants thought home-based exercises were easy to perform, however others reported a lack of motivation to complete these at home. The complexity of exercises and patients’ motivations can impact on patients’ commitment to home-based exercise.40 Our findings suggest that by attending face-to-face sessions, some participants felt more motivated to perform the exercises at home. These findings suggest that a combination of supervised and home-based exercises is likely to be the most beneficial for improving patients’ long-term commitment to therapeutic exercises.

Clinicians’ perceptions about interventions tested within the trial also influenced patients’ perceptions about the efficacy of the prescribed exercises. Clinicians are likely to have a strong input into patients’ perceptions about their condition and the relevance of the treatment received.41 In this study, some clinicians were not completely comfortable with changing their practice to follow the protocol of the trial and the issues raised by participants are very similar to those raised in other literature.11 These findings highlight the need to have clinicians onboard with the planned intervention. Clinicians’ input at the design stage may help reduce perceived barriers and providing training and education in research and trial methods could reduce those barriers.11,42,43

Participants suggested presenting more information about the management of shoulder pain within the planned interventions, including the “dose” of home-based exercises. These suggestions will be incorporated by the research team when planning the full trial. Adding supporting material to participants could also address their requests for understanding why their shoulder hurts. Participants also showed interest in knowing the results of the feasibility trial. At the time of the interview, we had not completed the analyses of the trial, so we could not share findings with participants. We did, however, share the main findings with participants once data analyses and the report were completed. This is considered best practice in research and is an important aspect of dissemination of study results.44,45

This study has limitations. Nine participants opted to not take part in the study. It is possible that these participants had different perspectives and experiences about the feasibility trial. On the other hand, we reached data saturation during the interview of those 16 participants who agreed to take part in the study, so we consider it likely that we have identified the key issues faced by participants during the study. Further, we recorded limited information about participating interviewees demographics, so as to minimize burden, thus we cannot exclude the possibility of sociodemographic bias. Our findings suggest participants included in the study had heterogeneous occupations (which imply different levels of education and income). Despite the heterogeneous occupations held by participants, they all presented similar perspectives regarding the trial.

This study explored participant perceptions of the feasibility trial which compared a tailored intervention to a standardised strengthening programme. Our findings suggest participants volunteered mainly to access healthcare for a specific issue that happened to match the trial requirements and to contribute to research. We found that participants valued the personalised care, perceived that their engagement within the trial improved their self-management and self-efficacy behaviour, valued the time spent with clinicians to receive interventions planned, as well as the empathetic environment of and education received during the trial. Participants recommended areas that could improve the design of the full trial including the health literacy level of written materials, making sure potential participants were aware of the time required to participate in a trial, and consideration be given to how to best encourage participant motivation to perform the exercises at home. We also found that clinicians’ perceptions of the trial influenced participants’ perceptions (in a negative way). Both the facilitators and barriers will require careful consideration in the future as the barriers may impact on reliability and validity of future trial results.