A Core Outcome Set (COS) for treatment of adolescent idiopathic scoliosis (AIS) is essential to ensure that the most meaningful outcomes are evaluated and used consistently. Measuring the same outcomes ensures evidence from clinical trials and routine clinical practice of different treatments can be more easily compared and combined, therefore increasing the quality of the evidence base. The SPINE-COS-AYA project aims to develop a gold standard COS which can be used internationally in research and routine clinical practice to evaluate the treatment (surgical and bracing) of AIS. In this qualitative study, the views of adolescents and young adults with AIS (10-25 years of age), their family members and healthcare professionals in a UK region were sought, via interviews, on treatment outcomes. Participants were purposively recruited from a variety of sources including NHS outpatient clinics and social media. Semi-structured interviews were analysed using thematic analysis. Key findings will be presented, to include potential core outcome domains identified by the different subgroups. The core outcome domains identified in this research programme will subsequently form part of an international consensus survey to agree a COS. In future, if the COS is used by healthcare staff and researchers, it will be easier for everyone, including patients and their families, to assess which treatment works best

Background and purpose:. Inconsistent outcome reporting is a problematic issue in systematic reviews of clinical trials in non-specific LBP (NSLBP). To facilitate statistical pooling and improve reliability of reviews, the development of a core outcome set (COS) is recommended. In 1998, Deyo et al. proposed a standardized set of domains and measurement instruments for LBP clinical research. An international steering committee (ISC) was formed to update 1998 recommendations, and to determine, at first, which outcome domains should be included in a COS for clinical trials in NSLBP. Methods:. The ISC used the OMERACT framework 2.0 to draw a list of potential core domains. This list was presented in a 3-round Delphi survey, in which researchers, clinicians and patients were invited to participate. Criteria for consensus were established a-priori and quantitative responses were analysed together with arguments provided by Delphi participants. The ISC discussed the results and made final decisions. Results:. 280 ‘experts’ were selected and invited to participate in the Delphi survey. Response rates in the three rounds were: 52%, 50%, and 45%. A list of 41 potential core domains was presented but 28 of them did not reach sufficient consensus to be presented in the third round, where overall consensus was reached on three domains: ‘physical functioning’, ‘pain intensity’ and ‘health-related quality of life’. Conclusion:. ‘Physical functioning’, ‘pain intensity’ and ‘health-related quality of life’ were included in this COS, together with the reporting on ‘number of deaths’. The next step in the development of this COS will be to determine which measurement instruments are most fit-for-purpose to measure these outcome domains

Background & purpose. Measurement inconsistency across clinical trials is tackled by the development of a core outcome measurement set. Four core outcome domains were recommended for clinical trials in patients with non-specific LBP (nsLBP): physical functioning, pain intensity, health-related quality of life (HRQoL), and number of deaths. This study aimed to reach consensus on core instruments to measure the first three domains. Methods & Results. The Steering Committee overseeing this project selected 17 potential core instruments for physical functioning, three for pain intensity, and five for HRQoL. Evidence on their measurement properties in nsLBP was synthesized in three systematic reviews using COSMIN methodology. Researchers, clinicians, and patients (n = 208) were invited in a Delphi survey to seek consensus on which instruments to endorse as core. Consensus was a-priori set at 67% of participants agreeing on endorsing an instrument. Two Delphi rounds were run (response rates = 44% and 41%). Agreement was reached on endorsing the Oswestry Disability Index (ODI 2.1a) for physical functioning, the Numeric Rating Scale (NRS) for pain intensity, but not on other instruments. Several participants demanded to have free of charge core instruments. Taking these results into account, the steering committee formulated the following recommendations: ODI 2.1a or 24-item Roland Morris Disability Questionnaire for physical functioning, NRS for pain intensity, Short-Form 12 or 10-item PROMIS Global Health for HRQoL. Conclusion. A core outcome measurement set is available for clinical trials in patients with nsLBP. High quality clinimetric studies directly comparing recommended and not recommended instruments are required. Conflict of interest: None. Source of funding: EUROSPINE, The Spine Society of Europe

Aims. Cauda equina syndrome (CES) can be associated with chronic severe lower back pain and long-term autonomic dysfunction. This study assesses the recently defined core outcome set for CES in a cohort of patients using validated questionnaires. Methods. Between January 2005 and December 2019, 82 patients underwent surgical decompression for acute CES secondary to massive lumbar disc prolapse at our hospital. After review of their records, patients were included if they presented with the clinical and radiological features of CES, then classified as CES incomplete (CESI) or with painless urinary retention (CESR) in accordance with guidelines published by the British Association of Spinal Surgeons. Patients provided written consent and completed a series of questionnaires. Results. In total, 61 of 82 patients returned a completed survey. Their mean age at presentation was 43 years (20 to 77; SD 12.7), and the mean duration of follow-up 58.2 months (11 to 182; SD 45.3). Autonomic dysfunction was frequent: 33% of patients reported bladder dysfunction, and 10% required a urinary catheter. There was a 38% and 53% incidence of bowel and sexual dysfunction, respectively: 47% of patients reported genital numbness. A total of 67% reported significant back pain: 44% required further investigation and 10% further intervention for the management of lower back pain. Quality of life was lower than expected when corrected for age and sex. Half the patients reported moderate or worse depression, and 40% of patients of working age could no longer work due to problems attributable to CES. Urinary and faecal incontinence, catheter use, sexual dysfunction, and genital numbness were significantly more common in patients with CESR. Conclusion. This study reports the long-term outcome of patients with CES and is the first to use validated patient-reported outcome measures to assess the CES Core Outcome Set. Persistent severe back pain and on-going autonomic dysfunction were frequently reported at a mean follow-up of five years. Cite this article: Bone Joint J 2021;103-B(9):1464–1471

Aims. To determine the value of scoliosis surgery, it is necessary to evaluate outcomes in domains that matter to patients. Since randomized trials on adolescent idiopathic scoliosis (AIS) are scarce, prospective cohort studies with comparable outcome measures are important. To enhance comparison, a core set of patient-related outcome measures is available. The aim of this study was to evaluate the outcomes of AIS fusion surgery at two-year follow-up using the core outcomes set. Methods. AIS patients were systematically enrolled in an institutional registry. In all, 144 AIS patients aged ≤ 25 years undergoing primary surgery (median age 15 years (interquartile range 14 to 17) were included. Patient-reported (condition-specific and health-related quality of life (QoL); functional status; back and leg pain intensity) and clinician-reported outcomes (complications, revision surgery) were recorded. Changes in patient-reported outcome measures (PROMs) were analyzed using Friedman’s analysis of variance. Clinical relevancy was determined using minimally important changes (Scoliosis Research Society (SRS)-22r), cut-off values for relevant effect on functioning (pain scores) and a patient-acceptable symptom state (PASS; Oswestry Disability Index). Results. At baseline, 65 out of 144 patients (45%) reported numerical rating scale (NRS) back pain scores > 5. All PROMs significantly improved at two-year follow-up. Mean improvements in SRS-22r function (+ 1.2 (SD 0.6)), pain (+ 0.6 (SD 0.8)), and self-image (+ 1.1 (SD 0.7)) domain scores, and the SRS-22r total score (+ 0.5 (SD 0.5)), were clinically relevant. At two-year follow-up, 14 out of 144 patients (10%) reported NRS back pain > 5. Surgical site infections did not occur. Only one patient (0.7%) underwent revision surgery. Conclusion. Relevant improvement in functioning, condition-specific and health-related QoL, self-image, and a relevant decrease in pain is shown at two-year follow-up after fusion surgery for AIS, with few adverse events. Contrary to the general perception that AIS is a largely asymptomatic condition, nearly half of patients report significant preoperative back pain, which reduced to 10% at two-year follow-up. Cite this article: Bone Joint J 2022;104-B(2):265–273