A quasi-randomised, controlled, feasibility trial of GLITtER (Green Light Imaging Interpretation to Enhance Recovery)—a psychoeducational intervention for adults with low back pain attending secondary care

Background Although it is broadly accepted that clinicians should endeavour to reassure patients with low back pain, to do so can present a significant clinical challenge. Guidance for how to provide effective reassurance is scarce and there may be a need to counter patient concerns arising from misinterpretation of spinal imaging findings. ‘GLITtER’ (Green Light Imaging Intervention to Enhance Recovery) was developed as a standardised method of communicating imaging findings in a manner that is reassuring and promotes engagement in an active recovery. This feasibility study is an important step towards definitive testing of its effect. Methods This feasibility study was a prospective, quasi-randomised, parallel trial with longitudinal follow-up, involving sampling of patients attending a spinal outpatient clinic at a metropolitan hospital. English speaking adults (18–75 years) presenting to the clinic with low back pain and prior spinal imaging were considered for inclusion. Eligible patients were allocated to receive a GLITtER consultation or a standard consultation (as determined by appointment scheduling and clinician availability), and were blinded to their allocation. Full details of the GLITtER intervention are described in accordance with the Tidier template.Follow-up data were collected after 1 and 3 months. The primary outcome of this study was the fulfillment of specific feasibility criteria which were established a priori. Determination of a sample size for a definitive randomised controlled trial was a secondary objective. Results Two hundred seventy-six patients underwent preliminary screening and 31 patients met the final eligibility criteria for study inclusion. Seventeen participants were allocated to the intervention group and 14 were allocated to the control group. Three month follow-up data were available from 42% of the 31 enrolled participants (N = 13, six intervention, seven control). Feasibility indicators for consent, resource burden and acceptability of the GLITtER intervention were met, however participant recruitment was slower than anticipated and an acceptable follow-up rate was not achieved. Conclusions Failure to achieve pre-specified recruitment and follow-up rates were important outcomes of this feasibility study. We attribute failure to issues that are likely to be relevant for other clinical trials with this population. It is realistic to consider that these challenges can be overcome through careful strategy, ample funding and continued partnership with health care providers. Trial registration The trial was registered on the Australian and New Zealand Clinical Trials Registry on 28/2/2017 (ACTRN12617000317392).


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88 Recent evidence reveals a high prevalence of common degenerative features in the imaging reports of 89 asymptomatic adults (Brinjikji et al. 2014). This indicates that many of these features -particularly 90 when found incidentally -should not be considered pathological and instead be regarded as normal 91 age-related changes. Coherent with this interpretation is that degenerative findings have been found to  121 This investigation was a prospective, quasi-randomised feasibility trial with longitudinal follow-up, 122 involving sampling of patients attending the Spinal Assessment Clinic (SAC). The study also adopted an 123 adaptive trial design, whereby modifications could be made during its conduct with the purpose of 124 increasing the probability of success of the study procedure or the intervention. Adaptations were 125 made during recruitment of the first one-third of participants, as pre-specified in the protocol 126 (https://osf.io/8zrq3/).

128 Study setting and participants
129 The study was conducted in the SAC, which operates in the Spinal Outpatient Department at a large 130 metropolitan hospital in South Australia. The SAC is a Physiotherapist-led clinic attended by patients 131 who warrant non-urgent consultation, as identified by a paper-based triage procedure prior to 132 appointment scheduling. All patients aged between 18 and 75 years who were scheduled to attend the 133 SAC with a lumbar spine disorder were considered for inclusion. To be eligible, patients were required to 134 be able to speak and understand (verbal and written) English and have access to recent images of their 135 lumbar spine. Baseline pain duration was not an eligibility consideration, however it was anticipated 136 that patients presenting to the SAC were likely to have experienced pain for longer than 3 months, 137 based on usual minimum timeframes for appointment scheduling. Patients with a history of lumbar 138 spine surgery were excluded.  Table 1 in accordance with the TIDieR 144 template for intervention description and replication (see www.equator-network.org). In brief -a 145 routine, or 'standard' consultation involves comprehensive patient assessment, review and 146 interpretation of relevant investigations and discussion of management recommendations. A key 147 objective of the patient-centered interaction is identification of potential surgical candidates, or the 148 guidance of patients appropriate for continued conservative care towards community-based options.
149 The GLITtER consultation includes all components of the standard consultation but is enhanced by the 150 implementation of a standardised framework through which imaging findings are interpreted (designed Manuscript to be reviewed 151 to optimise patient reassurance), includes provision of take-home resource, emphasizes the need for an 152 active recovery, and offers links to further information.

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154 Staff Training 155 Two SAC clinicians (clinicians 1 and 2) volunteered to deliver the GLITtER intervention and were 156 provided with training. Two clinicians (clinicians 3 and 4) remained naïve to GLITtER and agreed to 157 deliver the control intervention. A 3-stage training process was conducted for clinicians 1 and 2. The  The primary outcome of this study was the fulfillment of specific feasibility criteria that were established 168 a-priori (see Table 2) and designed to demonstrate that a subsequent effectiveness trial would be likely 175 variance of effect and data acquisition for a subsequent sample size calculation. We classified criteria 176 that met the standards specified in Table 2 as "achieved" and criteria that failed to meet these pre-177 specified standards (and would need addressing or adapting before proceeding with further testing of 178 the intervention as "review".

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The secondary outcomes of this study were: 181 1. Attainment of data permitting calculation of an appropriately powered sample for a subsequent RCT

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(i.e. the standard deviation of the NRS score for pain at 3-month follow-up). (from baseline to 3 month follow-up). 189 We aimed to allocate 40 study participants to intervention or control groups using a quasi-randomised 190 procedure. This sample size was considered adequate for a feasibility study (designed principally to 191 assess feasibility of recruitment and procedures), and sufficient to inform a power analysis for a 192 subsequent randomised controlled trial (Hertzog 2008).

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The full study procedure, including preliminary and primary screening procedures to determine patient 196 eligibility for participation, is outlined in Figure 1. 253 (see Appendix 6). 63% of study participants were female, and the mean age of participants was 50.1 254 years (standard deviation (SD) 14.0, range 20-75 years). All participants reported experiencing LBP for 255 more than 6 months. Key baseline data are reported in Table 3.

257 Interim evaluation
258 Interim evaluation occurred after the first 12 participants had been recruited into the trial. The main 259 issue discussed was the failure to consistently meet the weekly target for participant recruitment. An 260 unforeseen change to clinic process (with the result that fewer patients who were likely to be 261 recommended for conservative management received SAC appointments) was identified as the reason 262 for the lower number of patients meeting the final eligibility criteria than anticipated. While no 263 significant resolution to this issue was identified, the exclusion of patients who reported a past history of 264 spinal surgery was discussed. We recognised that many of these patients did not require further 265 imaging or surgical opinion and had the potential to benefit from GLITtER. The primary eligibility criteria 266 were revised to permit inclusion of participants who had had no more than 1 surgical procedure (more 267 than 2 years prior) and who met all other inclusion criteria. 271 responded to the participant satisfaction statements with ratings of "agree" or "strongly agree").
272 Clinicians delivering the GLITtER intervention also reported being satisfied with study processes. They Manuscript to be reviewed 277 Achievement outcomes of the pre-specified feasibility are provided in Table 2 and detailed below.

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279 Process considerations 280 A total of 31 participants were recruited from 15 clinic sessions. A CONSORT flow diagram detailing 281 study recruitment is provided in Figure 2. Of the 101 patients who met the primary eligibility criteria, 282 24 patients declined involvement. This resulted in a consent rate of 75%, which was considered 283 acceptable according to our pre-specified criteria. In addition to this however, 8% did not complete 284 signed consent forms due to unspecified reasons. An average of 2 participants were recruited each 285 clinic session, which was much less than our target recruitment rate of 4 participants per clinic session.
286 Further consideration and revision of recruitment feasibility is required. Acceptable participant follow-287 up response rates were also not achieved, with 1 and 3-month outcome data available for 36% and 42% 288 of participants respectively. 302 GLITtER consultation) were favourable (i.e. participants responded to the satisfaction statements with 303 ratings of "agree" or "strongly agree"). Clinicians 1 and 2 both reported that they were "confident" that 304 they could integrate GLITtER into standard practice on an ongoing basis (on a 4-point Likert scale ranging 305 from "not at all confident" to "very confident"). One clinician was "very confident" and the other was 306 "confident" that integrating GLITtER into routine consultations would enhance SAC care.  338 and investigate the potential for recruitment at multiple sites. The wording on the information sheet 339 should also be reconsidered to avoid the risk that some patients may have declined participation out of 340 concern that they would be given reassuring information during their consultation, rather than the 341 information that they were seeking.

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We achieved a 3-month participant follow-up rate of only 42%, which failed to meet our feasibility 344 criterion. In hindsight, our objective to achieve complete follow-up data from 95% response rate was 345 high -a drop-out rate of more than 20% is generally considered to compromise the validity of a clinical 367 that despite its length, it is not overly onerous for participants. The consent rate of 75% exceeded our 368 target rate, however it must be acknowledged that a further 8% of patients who met the primary 369 eligibility criteria did not either confirm or decline consent. Whilst a number of these exclusions were 370 likely to be related to procedural or timing issues it must be also considered that some of these patients 371 may have opted out of the study (without this action being recorded) -with impact on the overall 372 consent rate.

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374 This study employed rigorous scientific methods throughout. The protocol was developed in accordance 375 with the SPIRIT checklist and pre-registered on Open Science Framework. The trial was registered on 376 the ANZCTR and has been reported according to the CONSORT statement. Description of the GLITtER 377 intervention followed the TIDieR recommendations for reporting of clinical interventions and the NIHs 378 task force recommended minimum data set for LBP clinical trials was implemented. The specification of 379 feasibility criteria prior to conducting this investigation is a further strength of this study's design.

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381 Several weaknesses have also been recognised. There are no standardised criteria for evaluating 382 feasibility, or how achievement of the established criteria should be measured. We used an evidence-383 informed but ultimately investigator-led approach to identify and quantify our feasibility criteria, which 384 may not have been optimal. Factors such as participant adherence to management recommendations 385 and investigator burden could also have been considered. In addition, we consider that the ability to 386 engage clinicians and administrative personnel is imperative to the success of a clinical trial but we did 387 not formally assess engagement. Our sample size and our follow-up rate were smaller than we 388 expected, which resulted in less data to evaluate our feasibility criteria than we specified as a 389 requirement a priori. The study sample may therefore not be representative of the larger patient  412 Failure to achieve pre-specified recruitment and follow-up rates was disappointing, however these were  All procedures implemented in the standard consultation were included in the GLITtER consultation.
 Additional procedures (unique to the GLITtER consultation): i.
Provide detailed information about 'normal', age-relevant imaging findings and involve visual aid A. ii.
In addition to explaining patient's imaging findings, explain that: Scans (on their own) do not explain much about: -Your current pain (e.g. why you have good days and bad) -The activity you are capable of, or -How likely you are to recover (because the changes on your scans will still be there when your pain goes away) iii.
-Demonstrate spinal features that offer structural stability and emphasise the inherent strength of the spine. -Demonstrate musculature and joints -structures that need movement to be optimally healthy iv.
Promote using the 'TICtu list' as a strategy for increasing planned activity/exercise (see Appendix 8)