Table 1 Objectives and outcomes for the STIFF-F study

Primary objective:

Assess the feasibility of a multicentre RCT comparing IMN with CFEF.

Primary outcome:

Rates of recruitment and follow-up in a randomised pilot study.

• Rates of recruitment show that a multicentre RCT is not feasible.

Secondary objectives:

Identify conflicts or areas of concern for the research pathway compared with the clinical pathway.

Secondary outcomes:

Screening of all adults with segmental tibial fractures, including rationale for eligibility; patient interviews to identify challenges in pathway and factors influencing willingness to consent; staff interviews to determine surgeon and community equipoise, and challenges in the research pathway and culture.

• Sites reported screening patients in daily multi-disciplinary meetings and online systems with little conflict with clinical pathways. Both these methods were well established, and the trauma research teams were experienced. However, there iswas a lack of external data to put the study screening numbers in context. For example, segmental tibial fractures are not reported separately by the Trauma Audit and Research Network.

• Three patients declined participation in the study, two due to treatment preferences and one due to a dislike of randomisation.

• Surgeon difficulty with equipoise was identified as a barrier to recruitment in this study, with surgeons holding strong preferences based on their beliefs, experience and training.

Assess compliance with the randomised allocation.

Completion of allocated surgical procedure, rationale for all surgical/treatment activity.

• Two patients received their allocated treatment, and 1 died before treatment.

Estimate standard deviation of the outcome measure to estimate the definitive sample size.

Disability Rating Index (function) (DRI) [13].

• This was not estimated due to low recruitment numbers.

Evaluate feasibility of a definitive economic evaluation of IMN versus CFEF.

Health resource use and Health-Related Quality of life (EQ-5D-5L) [14].

• The feasibility study collected data on the use of health care services as well as costs to society in order to capture the overall cost of treatment for segmental tibial fracture. This study has shown that it is possible to collect the data necessary for a full cost-effectiveness analysis of IMNs and CFEFs. There were no practical issues to accessing information for collection and evaluation of the interventions.

Estimate quality of life post-fixation.

Pittsburgh Sleep Quality Index (PSQI) (15), Tampa Scale for Kinesiophobia (fear of movement/injury) (TSK) [16,17,18] and EQ-5D-5L [14].

• This was not estimated due to low recruitment numbers.

Estimate healing rates.

Radiological images assessed by the Radiographic Union Scale in Tibial fractures (RUST) score [19].

• This was not estimated due to low recruitment numbers.

Review current post-operative rehabilitation regimens.

Rehabilitation survey and interviews with staff and patients to identify current experience of rehabilitation.

• 11 hospitals responded to the survey.

• The findings of the survey suggest that protocols to direct rehabilitation for patients with a segmental tibial fracture are lacking.

• Interviews with patients and staff reveal that recovery for patients with a segmental tibial fracture is slow and arduous, and support is needed.

• Staff perceived patients with CFEF to have greater rehabilitative needs.

Examine variability of patient experiences of injury, treatment and recovery.

Interviews with patients to determine the impact of both treatments and outcomes important to them.

• Patient interviews revealed that recovery was slow and arduous for patients who received both IMN and CFEF.

Explore the views of clinicians and patients on the factors that facilitate or inhibit trial recruitment.

Interviews with staff and patients/consultee to identify the feasibility of undertaking a full trial.

Staff identified the following factors that inhibited recruitment to this study:

• Rarity of injury.

• Complexity and severity of the injury.

• Lack of individual surgeon equipoise.

• Surgical skill

• Slow site setup and a short recruitment window

• Concerns about the pragmatic nature of the trial

Staff identified the following factors that could facilitate recruitment to this study:

• A mix of surgical skills within the team

• Willingness to randomise to expertise

• Keen and experienced staff at sites