Abstract
Aims
To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures.
Methods
Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed.
Results
Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications).
Conclusion
Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required.
Cite this article: Bone Jt Open 2022;3(10):832–840.
Take home message
Substantial variation in outcome selection, assessment methods, and reporting quality inhibit efforts to synthesize research findings to inform care decisions.
Poor outcome reporting quality reduces confidence in the quality of trial data and the potential contribution to evidence-based healthcare.
Introduction
Ankle fractures, including distal tibial fractures, account for approximately 14% of fractures requiring hospitalization.1 Irrespective of age, they are associated with significant morbidity,1-3 pain, and impaired function, with a substantial reduction in ability to perform activities of daily life widely described. Evidence suggests that recovery from ankle fracture can be slow,4,5 with protracted physical and psychological implications,2,6 and a variable rate at which patients return to their pre-injury lives.4,5 Understanding and accurately assessing outcomes following ankle fracture is therefore important to informing high-quality research.
The results of clinical trials and subsequent evidence reviews are essential for guideline development for the management and care of patients with ankle fractures.7-9 However, where trials include a wide range of different outcomes (e.g. clinical, clinician-reported, patient-reported, economic impact, or resource use), such heterogeneity in outcome assessment can limit evidence synthesis or meta-analysis, detract from the developing evidence base to inform clinical practice, and contribute to research waste.10
Guidance for outcome reporting in ankle fracture trials do not currently exist, outcome reporting standards have not been defined, and the magnitude of inconsistencies in outcome reporting remains unknown. This review aims to describe the degree of variation and trends in outcome reporting in non-pharmacological randomized clinical trials (RCTs) of ankle fractures, including distal tibial fractures.
Methods
The review adheres to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.11
Search strategy
Five online databases were searched (January 2000 to February 2022): Medline (OVID), Embase (OVID), PsycINFO (OVID), CINAHL, and AMED. Three trial registries were screened: ISRCTN, ICTRP, and ClinicalTrials.gov. A comprehensive search strategy, translated for each database, was defined (Supplementary Table i). Hits were imported into EndNote (Clarivate Analytics, USA) and duplicates removed.
Eligibility criteria
Inclusion criteria were: randomized clinical trials examining non-pharmacological interventions for adults with an ankle fracture (AO/OTA type 43 and 44 fractures,12 and available in English as full-text articles published in peer-reviewed journals. Exclusion criteria were: multiple lower limb fractures that include the ankle (e.g. foot, tibia), or paediatric patients; screening, diagnostic methods, or involving animals or cadavers; conference proceedings, abstracts, or editorials.
Trial selection
Two authors (NAP, KLH) independently screened titles and abstracts for eligibility, and reviewed retained full-text articles: all were screened by NAP; KLH screened a 10% subset. Agreement was checked; a third author (ET) helped to resolve any disagreements. Reference lists of included trials and meta-analyses were reviewed.13-15
Data extraction
A pre-defined data extraction form (Excel; Microsoft, USA) was developed.16 Trial-specific information included: author, publication year, country, type of fracture, patient population, trial intervention(s), reported outcomes, and assessment method. All outcomes were extracted verbatim based on assessment focus, method, timing, and reproducibility (i.e. adequate citation or detail supporting reproduction). Outcomes were mapped to pre-defined domains informed by the core International Classification of Functioning, Disability and Health (ICF) framework:17 body structure and function, activities, and participation. Additional (sub)domains were iteratively added to reflect commonly reported outcomes in included trials.16
Data analysis
Descriptive statistics were used to describe pattern of outcome reporting including numbers of trials and frequency of outcome reporting, assessment focus (what was assessed), and methods (how were outcomes assessed).16 Assessment timings and the quality of outcome reporting were also analyzed. Reporting quality considered the reproducibility of outcome assessments: i.e. was sufficient detail, or appropriate citation, provided to allow assessment reproduction.16 The proportion of outcomes judged to be reproducible were categorized as: poor (< 30%); low (31% to 49%); moderate (50% to 69%); or high (> 70%).
Patient and public involvement
Three experienced patient research partners contributed to all stages of the review process.
Results
From 7,623 results, 148 full-text articles were reviewed and 48 excluded (Figure 1). Five additional articles were identified after reference screening. In total, 105 trials were included (Supplementary Table ii).
Fig. 1
Preferred Reporting Items for Systematic Reviews and Meta-Analyses flowchart of trial selection process.
Trial characteristics
Included trials compared: surgical interventions (n = 62), post-surgical injury management options (n = 17), rehabilitation approaches (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgery management strategies (n = 5) (Table I). Almost half (n = 47; 45%) were conducted in the past five years. Most were small trials, including < 100 participants (n = 79/105; ranging from 16 to 669; median 64 (interquartile range (IQR) 58 to 605)). Trials were from 27 countries; most were from the UK (n = 12), China (n = 11), Finland, the USA, and South Korea (n = 8).
Table I.
Characteristics of included trials (n = 105).
| Characteristics | Trials, n |
|---|---|
| Number of participants | |
| 1 to 50 | 37 |
| 51 to 100 | 42 |
| 101 to 150 | 12 |
| > 150 | 14 |
| Age, yrs | |
| Mean (range) | 45.9 (15 to 98) |
| Median (IQR) | 43.5 (7.22 to 45.50) |
| Not stated | 5 |
| Interventions | |
| Pre-surgical management | 5 |
| Surgical | 62 |
| Surgical vs non-surgical | 6 |
| Post-surgical management | 18 |
| Rehabilitation | 14 |
| Continent | |
| Africa | 3 |
| Asia | 34 |
| Australasia | 7 |
| Europe | 47 |
| North America | 14 |
-
IQR, interquartile range.
Which outcomes are assessed in ankle fracture trials?
From a total of 888 extracted outcome assessments (i.e. the total number of outcome assessments reported across all trials), 337 clearly defined, discrete outcomes were identified e.g. the Olerud-Molander Ankle Score (OMAS),18 pain severity with a clearly described visual analogue scale (VAS), or the American Orthopaedic Foot Ankle Score (AOFAS)19 (Table II). While a third (32.3%; n = 123) of these discrete outcomes were each assessed in two or more trials, most (67.8%; n = 258) were assessed just once in single trials. The number of outcomes reported per trial ranged from 1 to 25 (median 8 (IQR 6 to 17)) (Table III).
Table II.
Trial outcome reporting across health domains. Expanded definitions can be found in Supplementary Table iii.
| Domain | Outcome reporting across trials | |||
|---|---|---|---|---|
| Outcome assessments, n | Discrete outcomes, n | Trials, n (%) | Reproducibility of outcomes, % | |
| Body structure and function | 263 | 99 | 90 (85.7) | 60.1 |
| Body structure | ||||
| Radiological fracture assessments | 104 | 32 | 58 (56.2) | 66.0 |
| Body function | ||||
| Ankle swelling and alignment assessments | 53 | 20 | 40 (38.0) | 71.7 |
| Blood chemistry | 11 | 11 | 2 (1.9) | 100 |
| Calf muscle assessments | 7 | 4 | 7 (46.7) | 85.7 |
| Joint range of motion | 88 | 32 | 45 (42.8) | 42.0 |
| Activities | 136 | 56 | 72 (68.6) | 82.4 |
| Ankle function | 59 | 9 | 56 (53.3) | 93.2 |
| Basic activities of daily living | 36 | 25 | 21 (20.0) | 61.1 |
| Instrumental activities of daily living | 25 | 14 | 20 (19.0) | 84.0 |
| Physical activities | 16 | 8 | 11 (10.5) | 87.5 |
| Participation | 34 | 13 | 25 (23.8) | 20.6 |
| Participation in social and leisure activities | 8 | 4 | 8 (7.6) | 75.0 |
| Return to work | 20 | 6 | 20 (19.0 | 5.0 |
| Return to sport or leisure activity | 6 | 3 | 6 (5.7) | 0 |
| Health-related quality of life | 159 | 61 | 65 (61.9) | 72.3 |
| General health | 13 | 7 | 13 (12.4) | 53.8 |
| Mental health | 24 | 8 | 18 (17.1) | 75.0 |
| Multi-domain assessment | 29 | 11 | 29 (27.6) | 89.7 |
| Pain | 80 | 31 | 49 (46.7) | 66.3 |
| Physical health | 13 | 4 | 12 (11.4) | 84.6 |
| Processes of care | 247 | 95 | 84 (80.0) | 87.0 |
| Complications | 186 | 74 | 77 (73.3) | 82.8 |
| Hospital-specific outcomes | 25 | 7 | 22 (20.9) | 100 |
| Surgery-specific outcomes | 36 | 14 | 25 (20.0) | 100.0 |
| Patient experiences | 21 | 13 | 16 (6.7) | 4.8 |
| Satisfaction with care or treatment | 12 | 6 | 11 (10.5) | 0 |
| Satisfaction with outcomes | 6 | 4 | 5 | 16.7 |
| Perceptions of recovery | 3 | 3 | 2 | 0 |
| Economic assessment | 28 | 25 | 9 | 82.1 |
| Total | 888 | 337 | 105 | 58.5 |
-
*
Total number (frequency) of outcome assessments reported across trials.
-
†
Clearly defined and reproducible discrete outcome.
Table III.
Number of outcomes reported per trial.
| Number of outcomes | Trials (n = 105) |
|---|---|
| 1 | 3 |
| 2 to 5 | 29 |
| 6 to 10 | 47 |
| 11 to 20 | 24 |
| 21+ | 2 |
All outcome assessments were assigned to one of seven domains, with 24 sub-domains further defined (Table II). When assessed by frequency of outcome reporting, most assessments focused on body structure or function (n = 263/880 outcomes, 29.6%), processes of care (n = 247/880, 27.8%), health-related quality of life (HRQoL) (n = 159/880, 17.9%), and activities (n = 136/880, 15.3%). Participation (n = 34/880, 3.8%), economic assessments (n = 28/880, 3.2%), and patient experiences (n = 21/880, 2.4%) were less frequently assessed.
Body structure and function
Most trials reported at least one assessment of body structure or function (n = 90/105; 85.7%): 99 discrete outcomes contributed to 263 outcome assessments across the five sub-domains. Radiological assessments (n = 104 outcome assessments; n = 32 discrete outcomes; 55.2% of trials) and joint range of motion (n = 88 outcome assessments; n = 32 discrete outcomes; 42.9% of trials) were the most frequently assessed outcomes. Assessment reproducibility ranged from 42% for range of motion to 100% for blood chemistry.
Processes of care
Processes of care were assessed in most trials (n = 84/105; 80%): 95 discrete outcomes contributed to 247 outcome assessments across three sub-domains. Complications were most frequently reported (n = 77/105 trials (73.3%)), with 74 discrete outcomes contributing to 186 outcome assessments. Reproducibility was high (82.8%). Hospital-specific outcomes (e.g. length of hospital stay, and re-admissions) were assessed in 21% of trials (n = 22/105). The 25 outcome assessments (of which seven were discrete) were highly reproducibility (100%). Surgery-specific outcomes were assessed in 23.8% (n = 25/105) trials. The 36 outcome assessments (of which 14 were discrete) were highly reproducible (100%), and included the duration of surgery or assessments of blood loss.
Health-related quality of life
More than 60% of trials included at least one health-related quality of life (HRQoL) assessment (n = 65/105; 61.9%): 61 discrete outcomes contributed to 159 outcome assessments across five sub-domains. A total of 11 discrete, multi-domain assessments, e.g. the 36-Item Short-Form Health Survey (SF-36)20 and EuroQol five-dimension questionnaire (EQ-5D),21 contributed to 29 outcome assessments across 29 trials (27.6%). Seven discrete assessments of general health, often with single-item VAS such as the EQ-VAS, contributed to 13 outcome assessments across 13 trials (12.4%). The most widely reported discrete outcome assessments of HRQoL were the EQ-5D, SF-36, and SF-12. Overall, reproducibility was high (72.3%).
The most widely assessed sub-component of HRQoL was pain, reported by almost 50% of trials (46.7%): 31 discrete ‘pain’ outcomes contributed to 80 outcome assessments. Overall, 18 of the discrete outcomes were single-item assessments of pain intensity, and 13 were sub-domains or components of existing measures (e.g. from the American Academy of Orthopaedic Surgeons Foot and Ankle Questionnaire (AAOS),22 American College of Foot and Ankle Surgeons (ACFAS),23 EQ-5D, or Mazur Ankle Score24 and McGuire Scoring Criteria).25 Pain experienced under specific conditions was also assessed (e.g. during walking, at rest, at night). Reproducibility was moderate (66.3%).
Few trials specifically assessed the impact of ankle fracture on mental health (17.1%). From 24 outcome assessments, eight discrete outcomes were described, taken from existing HRQoL assessments, most commonly the SF-36 (n = 9) and SF-12 (n = 4) mental health scores. Reproducibility was high (75%).
Activities
Many trials reported at least one measure of activity (n = 72/105; 68.6%): 61 discrete outcomes contributed to 136 outcome assessments across the four sub-domains. Most frequently assessed was ‘Ankle function’ (n = 59 outcome assessments); the nine discrete outcomes included the Ankle Osteoarthritis Scale,26 Foot Function Index,27 and the OMAS (most widely used in 49 (46.7%) trials). Basic activities of daily living were also widely assessed with 25 discrete outcomes contributing to 36 outcome assessments. Except for ‘basic activities of daily living’ (reproducibility 61.1%), reproducibility was high (84.0% to 93.2%).
Participation
Fewer than 25% of trials assessed participation; 13 discrete outcomes contributed to 34 outcome assessments across the three sub-domains. Multi-domain assessments were largely reproducible (75%), but this reduced substantially when single-item VAS or numeric rating scales were used (5% and 0%, respectively). Content predominantly reflected returning to work, sport, or leisure activity.
Economic assessments
Across nine trials, 25 discrete outcomes contributed to 28 economic outcome assessments e.g. absenteeism, costs of treating complications, days away from paid work or unpaid activities, and direct healthcare costs. Broadly, outcomes were well described and reproducible (82.1%).
Patient experiences
Few trials assessed patient experience (15.2%): 16 discrete outcomes contributed to a total of 21 outcome assessments. Assessments were typically related to patient satisfaction with care or treatment (n = 12), outcomes e.g. scar appearance or comfort (n = 6), or recovery (n = 3). Reproducibility was poor (range 0% to 16.7%). Simple VASs were widely used, with little detail supporting reproduction.
Assessment timing
The 888 reported outcomes were captured across 1,955 timepoints. Most were collected between months two and three (38.2%; n = 744) post-injury. Around 20% were collected between months four to six (n = 387), and similarly between months seven and 12. Only 132 assessments (6.8%) were taken after one year (Figure 2). The number of outcome assessments by domain and timepoint is presented in Figure 3.
Fig. 2
Proportion of outcomes assessed at each timepoint.
Fig. 3
Timing of outcome assessment by domain. HRQoL, health-related quality of life; ICF, International Classification of Functioning, Disability and Health framework.
Quality of outcome reporting
Across all domains, assessment reproducibility was just 58.5%. Assessments of blood chemistry (100%), ankle function (93.2%), and processes of care outcomes (87%) were among the most clearly reported and hence reproducible assessments. Assessments of patient experience (4.8%), participation (20.6%), joint range of motion (42.0%), general health (53.8%), and pain (66.3%) were less clearly reported and hence less reproducible (Table II). Overall, just over 50% (n = 53) of reviewed trials included two or more non-reproducible outcomes.
Discussion
This review describes the substantial heterogeneity and inconsistency in outcome reporting across published trials of distal tibial and ankle fracture with regard to which outcomes are assessed, and how and when assessments are undertaken. Such inconsistency of outcome reporting is described across the recovery journey, expanding on an earlier review by McKeown et al,6 which highlighted the wide range of primary outcome measures reported in ankle fracture trials.
The lack of outcome reporting guidance following ankle fracture is evident. Despite the large number of outcomes reported, few are reported across multiple trials. The short-term assessment of clinically focused domains of body structure and body function dominate outcome reporting, with little attention to the long-term consequences from the perspective of patients. While such assessments are important to understanding the clinical impact of ankle fracture and its management, they tell us little about what really matters to patients, how they understand their recovery journey, and their healthcare needs. Apart from pain, outcomes that may be important to patients, such as emotional impact and return to normal activities, are rarely assessed. Moreover, the quality of outcome reporting (assessment reproducibility) varied widely; when poor, this reduces confidence in data quality and inhibits data synthesis with which to inform care decisions. High-quality, standardized assessment that captures the outcomes that matter to key stakeholders is urgently required.
The review benefited from a transparent data extraction process which captured the many outcome reporting challenges.16 An extensive literature search of five major medical and three clinical trial databases was supplemented by citation searching of included trials. The inclusion of all eligible international publications aimed to reduce any publication bias that may have occurred by including only English-language publications. With a focus towards improving the standardization of outcome assessment in clinical trials, the review did not include alternative studies, such as observational or cohort studies. The review only included trials of adults with fractures; a review of outcome reporting in trials of childhood fractures has similarly highlighted outcome reporting heterogeneity.28 Although of potential relevance to the quality of outcome reporting, trial quality was not evaluated. Moreover, although important to informing outcome selection, this review did not extend to assessing the relative quality and acceptability of identified assessment methods.
Well-developed patient-reported outcome measures (PROMs) are single or multi-item questionnaires, intended to measure aspects of health that are important to patients.29,30 Providing important complementary evidence to traditional clinically based outcomes, their inclusion in clinical trials is strongly advocated.29,30 Moreover, where treatment goals include symptom reduction and enhancement of function and quality of life, PROMs have a central role in treatment optimization. However, this review describes the infrequent use of PROMs in trials of ankle fracture: while around 50% of trials included a patient-reported assessment of ankle function (most often the OMAS) and/or pain, fewer than 30% included multi-domain assessments of HRQoL, and just 12% assessed general health. Moreover, recent reviews highlight the inadequacies of several ankle-specific patient-reported outcomes including the OMAS, the AOFAS, and the Ankle Fracture Outcome of Rehabilitation Measure,31 suggesting insufficient evidence of essential measurement properties to recommend their use following ankle fracture.32,33 Major concerns related to inadequate content validity, measurement focus, evidence of measurement validity, responsiveness to change, and interpretative guidance. The widespread use of measures that lack fundamental measurement properties undermines the quality of trial data, reducing confidence in results.
Few trials assessed emotional wellbeing, participation or return to ‘usual’ activities, or patients’ perceptions of recovery. Moreover, most assessments were short-term (two to three months post-fracture); few assessments extended beyond one year. The life and wellbeing of people who sustain an ankle fracture is substantially disrupted, bringing both short- and longer-term challenges.2,4,5 Awareness of the broad-ranging injury impact, and the time taken to return to ‘normality’, is important to ensuring appropriate, long-term assessment of meaningful outcomes.
This review describes an important lack of data clarity and integrity in outcome reporting, which undermined the quality of outcome reporting and assessment reproducibility: numerous potential outcome assessments were excluded from the review due to insufficient detail. This was particularly troublesome for the assessment of ankle range of motion where patient position and direction of ankle movement (e.g. inversion, eversion, dorsi- or plantar-flexion) was poorly conveyed. The utilization of trial data to inform evidence syntheses, decision-making, and guideline development is dependent upon good-quality data, and requires urgent attention in this field. The use of established trial outcome reporting guidelines such as the CONSORT-PRO extension34 is recommended.
An iterative approach to mapping outcomes to domains, informed by the ICF framework,16,17 evidenced the diversity of outcome assessment in ankle fracture trials. Most commonly, trials included outcomes within the body structure and function (85.7%), processes of care (80%), and activities (68.5%) domains.
Complications, one aspect of the processes of care domain, were the most frequently reported outcomes. However, 74 discrete outcomes reported across 77 trials (73%) suggests that most trials included an assessment of different complications. Radiological outcomes were the second most frequently assessed (56% of trials). Substantial variation is evident, with 32 discrete outcomes reported across 58 trials. However, the limited clinical relevance of follow-up radiological assessment in ankle fracture management, in the absence of patient-reported symptoms, has been described.35 Moreover, there is little evidence of the association between radiological and patient-reported outcomes.6 Of note, almost 45% of trials did not include radiological assessment, perhaps reflecting the different focus of reviewed trials, e.g. rehabilitation.
Pain was assessed in almost 50% of trials. However, further outcome reporting heterogeneity is described, with 31 discrete outcomes described across the 49 trials. Moreover, assessment largely used poorly defined, single-item scales, such as VAS. While pain is clearly an important outcome following an acute injury, the relative importance afforded to pain by patients in comparison to other patient-important outcomes, particularly over the longer term, is not clear. Understanding how patients prioritize outcomes following an ankle fracture would ensure that future trials capture patient-important outcomes.
This review has described the substantial inconsistencies in outcome reporting, over both the short and longer term, the greater weight afforded to clinically based assessment, and the limited engagement with patients to better understand their perceptions of recovery and what a ‘good outcome’ following ankle fracture looks like. Moreover, the general quality and reproducibility of outcome reporting was often poor. Standardization of outcome reporting, in the form of a core outcome set, for clinical trials of ankle fracture is highly recommended.36 A core outcome set seeks to define agreed and evidence-based guidance for a minimum number of outcomes which should be reported in all trials for a defined health condition.37 Such guidance is currently available for several adult fractures, including proximal humerus,38 distal radius,39 hip,40 and open lower limb fracture.41
Development of a Core Outcome Set for distal Tibia and Ankle fractures (COSTA) would support the standardization of outcome reporting in clinical trials and future evidence syntheses upon which clinical, policy, and healthcare decisions are based. Adopting a multi-stakeholder perspective including clinicians and patients will ensure that outcomes of relevance to key stakeholders are considered alongside methods of assessment that are both robust and relevant, supporting future adoption.
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Author contributions
N. A. Pearson: Project administration, Investigation, Data curation, Formal analysis, Writing – original draft, Writing – review & editing.
E. Tutton: Methodology, Supervision, Formal analysis, Writing – review & editing.
A. Joeris: Conceptualization, Funding acquisition, Formal analysis, Writing – review & editing.
S. E. Gwilym: Conceptualization, Funding acquisition, Formal analysis, Writing – original draft, Writing – review & editing.
R. Grant: Formal analysis, Writing – review & editing.
D. J. Keene: Conceptualization, Formal analysis, Writing – review & editing.
K. L. Haywood: Conceptualization, Methodology, Funding acquisition, Supervision, Investigation, Formal analysis, Visualization, Writing – original draft, Writing – review & editing.
Funding statement
The authors disclose receipt of the following financial or material support for the research, authorship, and/or publication of this article: this research was supported by a research grant awarded to Warwick Medical School, University of Warwick by the AO Foundation (no grant number assigned). Professor Haywood was chief investigator for the study.
ICMJE COI statement
D. J. Keene was a co-investigator for the AIM trial and is lead investigator for the AFTER trial, both are NIHR-funded ankle fracture trials in the UK. A. Joeris is employed by the AO Foundation.
Acknowledgements
We would like to thank AO Trauma for funding this project and Sam Johnson for her expertise in supporting development of the literature search strategies. We also thank our COSTA collaborators Andrew Metcalf, Joel Humphrey, Marilyn Heng, Marinis Piripiris, Martin Underwood, Prakash Jayakumar, Rebecca Kearney, Rodrigo Pesantez, and Simon Lambert for their contribution to the study design. We would also like to thank the study patient and public involvement group for their contributions to the study.
Ethical review statement
No ethical approval was required for the purposes of completing this systematic review of published work.
Open access funding
The open access fee for this study was funded by a research grant awarded to Warwick Medical School, University of Warwick by the AO Foundation.
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Supplementary material
Tables showing example search strategy, list of included trials, and expanded definitions of terms used in Table II.
© 2022 Author(s) et al. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives (CC BY-NC-ND 4.0) licence, which permits the copying and redistribution of the work only, and provided the original author and source are credited. See https://creativecommons.org/licenses/by-nc-nd/4.0/
