Study configuration

FACTS is an observational, multicentre, prospective cohort study. Treatments will not be randomly allocated; patient care will be determined in the usual way as per the treating clinician.

Patients who meet the eligibility criteria (table 2) will be recruited from hand fracture clinics at participating National Health Service (NHS) hospitals. Where participants have multiple MSF with potentially variable fracture patterns, a single digit will be selected as the ‘study finger’. Participants with additional hand or upper limb injuries will be included and the latter recorded. Written informed consent will be obtained from all participants by an appropriately trained research associate prior to entering the study. Thereafter, participants will be reviewed in a face-to-face clinic visit at 6 weeks and remotely at 3 and 6 months. This was supported by previous studies of MSF reporting full range of motion in almost all patients by 6 months.17 Furthermore, previous studies in similar patient cohorts with follow-up of 12 months or longer suffered high drop-rates or struggled to recruit adequate numbers of participants. A participant pathway flowchart is illustrated in figure 1.

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Figure 1

Study flow diagram. MSF, metacarpal shaft fractures. SMS, Short Message Service.

A nested qualitative study consisting of two elements, patient interviews and focus groups, will be conducted to provide patient-centred insight into study procedures and explore the individual impact of the injury. Participants will be selected from the prospective cohort study, using purposive sampling that prioritises young males, and further written informed consent separately sought for this element of the study.

A detailed cost evaluation to establish the costs of treatments for MSF through representative micro-costing will be undertaken. Resource use directly linked to the MSF and its sequela and/or complications over the 6 months of follow-up will be recorded for each participant. Unit cost data will be obtained from national databases such as NHS reference costs, the British National Formulary (BNF) and Personal Social Services Research Unit (PSSRU) Costs of Health and Social Care.18

A two by two by two factorial randomised substudy will be nested within the main cohort study. Once participants have consented to the cohort study or qualitative study, they will be randomised to the following interventions to evaluate the use of text messages in maximising data collection and participant retention; frequency of text messages—either fortnightly or monthly; two-way communication—text message requiring a response from the participant versus a notification message only; and personalisation—a personalised message versus a standard automated message.

Treatment groups

Participants will enter a group according to their primary mode of treatment on enrolment into the study. Patients will undergo standard care as per their treating clinician. This will be decided by their clinical care team and will not be affected by their involvement in the study. Treatment groups will be defined as follows;

Surgery: any surgical treatment, defined as insertion of metal via an open or percutaneous approach in an operating theatre, such as open reduction internal fixation, closed reduction internal fixation, intramedullary fixation or wiring, extramedullary wiring or external fixation.

Non-surgical treatment: any ‘non-surgical’ treatment, defined as regimens with or without reduction (partial or complete) of the fracture, any type of splinting or cast, and/or immediate or delayed mobilisation delivered in a clinic or therapy room environment.

Outcomes

Participants will be invited to attend a research clinic at 6 weeks following injury. During this visit, clinical assessments of their hand including range of movement, grip strength and presence of rotational deformity or extensor lag will be recorded. Radiographs taken as part of routine clinical care will also be reviewed. The location, fracture morphology, amount of shortening, angulation and presence of step-off deformity on initial radiographs at presentation will be recorded. Complications will be identified by review of the patients’ healthcare records at 6 weeks, 3 months and 6 months. Cosmesis will be assessed from question 10 of the Patient Evaluation Measure (PEM), at 6 weeks, 3 months and 6 months. Participant-reported complications will be recorded at the 6-week research clinic visit.

The following PROMs were selected for use following discussions between clinicians, patients, therapists and researchers at the MSF consensus workshop.16 They were prioritised due to their ease of use and validity and will be collected at baseline, 6 weeks, 3 months and 6 months.

Sample size and Justification

As this is a feasibility study, formal sample size calculations for between-group comparisons are not appropriate. However, we will seek to include as many as 84 participants in the study, aiming for comparable numbers in each treatment group. This sample size will enable estimation of recruitment fraction with margin of error (half width of 95% CI) of <9 percentage points and of proportions estimated from the recruited sample, such as completeness of follow-up, to within 13 percentage points.

A purposive sample of 12–16 participants, who indicate a willingness to be interviewed and/or attend focus groups, will be recruited to the qualitative study. Participants who decline to participate in the main cohort study will also be invited for interview.

Analysis of outcomes

The outcomes of interest include feasibility outcomes relating to; assessment of eligibility, recruitment and retention rates; completion of follow-up; evaluation of outcome measures and calculation of the MCID for selected outcome measures using quantitative and qualitative assessments; and establishing the feasibility of data collection methods and appropriate time-points for use in a future trial. To address these feasibility aims, data analyses will primarily be descriptive with 95% CIs to quantify uncertainty in estimates where appropriate.

MCID evaluation

Minimum clinically important differences for each PROM at 3 months will be estimated using three anchor-based responsiveness statistics: (1) standardised response mean; (2) effect size and (3) Guyatt’s Responsiveness Index. An estimation of the MCID will also be calculated by distribution-based methods, using the SE of measurement, SD and effect size. The minimal detectable change will also be calculated to ensure the MCID is greater than the measurement error of the PROM. The sensitivity and specificity of the PROM will be assessed in conjunction with the MCID, as calculated above.

Costing of interventions

Direct observation of procedures will be used to produce a ‘micro-cost’ estimate for surgical and non-surgical treatments by combining resource use with unit costs provided by hospital finance departments. Duration of each procedure, theatre staffing, consumables, imaging, supplementary devices, postoperative recovery time and rehabilitation inputs will be recorded from primary sources, such as theatre log systems and patients’ electronic and paper clinical records. Standard unit costs will be used to estimate NHS costs of care in the 6-month post-treatment. Unit cost data will be obtained from national databases such as the BNF and PSSRU Costs of Health and Social Care 2019.18

There is a need to define the economic morbidity of MSF in terms of the costs of treatment and associated resource use, productivity losses and additional costs incurred by patients during the course of their treatment and recovery. Identifying the costs of treatments will help to establish the feasibility of collecting utility and cost data in a future trial, as well as devising methods for accurately collecting such data to ensure robust cost-effectiveness comparisons in a future trial.

Qualitative analysis

A thematic, inductive approach as described by Braun and Clarke27 will be used to analyse interview and focus group data. We will adopt a six-phase systematic approach consisting of (1) data familiarisation—reading and re-reading the data; (2) generation of initial codes—generating succinct labels (codes) that identify important features of the data that might be relevant to answering the research question; (3) identification of themes through merging and grouping of codes—to identify significant broader patterns of meaning (potential themes) and collating data relevant to each theme; (4) review of generated themes—checking themes against the dataset and refining them where necessary; (5) defining and naming themes—developing a detailed analysis of each and deciding the informative name for each theme and (6) finalisation of themes and generation of a final report—weaving together the analytic narrative and data extracts, and contextualising the analysis in relation to existing literature. NVivo 12 or above Pro software (QSR International Pty, Victoria, Australia) will be used for analysis.

Patient and public involvement statement

Patients and the public have played a central role in selecting the management of MSF as a key research priority and developing the proposed study. The Hand Surgery Research Prioritisation workshop, attended by clinicians, therapists and patients, recommended the management of MSF as a key research priority.28 This was ratified by the James Lind Alliance Priority Setting Partnership on Common Conditions Affecting the Hand and Wrist.16 This joint collaboration with the BSSH involved 261 individuals, of which 41% were patients/carers and 59% were clinicians.16

Furthermore, a MSF Consensus Workshop was held in Nottingham in 2018, bringing together patients with MSF, clinicians, therapists and researchers to share their experiences and develop the PICO framework for a future multicentre trial.16 Group discussions informed the eligibility criteria and identified areas of focus for the feasibility work. Selection of patient-centred outcome measures, timing of assessments and follow-up for the proposed study were discussed. A variety of outcome measures were reviewed and the QuickDASH and PROMIS-UE were subsequently added. One clinic visit in addition to virtual follow-up was included and follow-up was adjusted to 3 and 6 months following patient discussions. Feedback from patients who attended the workshop has informed all aspects of the research including research design, choice of outcome measures and length and location of follow-up.

The study protocol, participant information sheets and consent forms have been reviewed by PPI members, with feedback provided to optimise their utility. We have set up a Metacarpal Shaft Fracture Patient Advisory Group to inform the design, delivery and output of the research. An electronic PPI platform has been created on the Centre for Evidence Based Hand Surgery (CEBHS) website to encourage regular input from patients/public.

Feedback from the Metacarpal Shaft Fracture Patient Advisory Group will guide distribution of findings to the public. This will include, but not be limited to, newsletters, local media outlets, events and plain English summaries of all published journal articles.

Incorporating patient and public involvement in all aspects of the research pathway, from research design to co-development and review of all study documents, supports our commitment to ensuring sustained and meaningful PPI throughout the study.

Study management

The study is funded by a National Institute for Health Research Doctoral Fellowship awarded to Miss Rowa Taha (NIHR300197). It is sponsored by the University of Nottingham and will be managed and co-ordinated from the Centre for Evidence Based Hand Surgery (CEBHS), University of Nottingham.