Advertisement for orthosearch.org.uk
Results 1 - 20 of 66
Results per page:
The Bone & Joint Journal
Vol. 106-B, Issue 10 | Pages 1176 - 1181
1 Oct 2024
Helenius L Gerdhem P Ahonen M Syvänen J Jalkanen J Nietosvaara Y Helenius I

Aims. Closed suction subfascial drainage is widely used after instrumented posterior spinal fusion in patients with a spinal deformity. The aim of this study was to determine the effect of this wound drainage on the outcomes in patients with adolescent idiopathic scoliosis (AIS). This was a further analysis of a randomized, multicentre clinical trial reporting on patients after posterior spinal fusion using segmental pedicle screw instrumentation. In this study the incidence of deep surgical site infection (SSI) and chronic postoperative pain at two years’ follow-up are reported. Methods. We conducted a randomized, multicentre clinical trial on adolescents undergoing posterior spinal fusion for AIS using segmental pedicle screw instrumentation. A total of 90 consecutive patients were randomized into a ‘drain’ or ‘no drain’ group at the time of wound closure, using the sealed envelope technique (1:1). The primary outcomes in the initial study were the change in the level of haemoglobin in the blood postoperatively and total blood loss. A secondary outcome was the opioid consumption immediately after surgery. The aim of this further study was to report the rate of deep SSI and persistent postoperative pain, at two years' follow-up. Results. As previously reported, the mean 48-hour opioid consumption was significantly higher in the no drain group (2.0 mg/kg (SD 0.8) vs 1.4 mg/kg (SD 0.7); p = 0.005). There were no delayed deep SSIs. At two years’ follow-up, the mean Scoliosis Research Society 24-item questionnaire (SRS-24) total score did not differ between the groups (4.11 (SD 0.47) vs 4.16 (SD 0.33); p = 0.910). The mean SRS-24 pain score was 4.28 (SD 0.48) in the no drain group compared with 4.33 (SD 0.66) in the drain group (p = 0.245). Seven patients (19%) in the no drain group and six in the drain group (14%) reported moderate to severe pain (numerical rating scale ≥ 4) at two years’ follow-up (p = 0.484). The general self-image domain score was significantly higher in the no drain group compared with the drain group (4.02 (SD 0.74) vs 4.59 (SD 0.54); p < 0.001). Conclusion. The main finding in this study was that more severe pain immediately after surgery did not result in a higher incidence of chronic pain in the no drain group compared with the drain group. Back pain and health-related quality of life at two years’ follow-up did not differ between the groups. The patient-reported self-image domain was significantly better in the no drain group compared with the drain group. Cite this article: Bone Joint J 2024;106-B(10):1176–1181


Bone & Joint Open
Vol. 5, Issue 7 | Pages 612 - 620
19 Jul 2024
Bada ES Gardner AC Ahuja S Beard DJ Window P Foster NE

Aims

People with severe, persistent low back pain (LBP) may be offered lumbar spine fusion surgery if they have had insufficient benefit from recommended non-surgical treatments. However, National Institute for Health and Care Excellence (NICE) 2016 guidelines recommended not offering spinal fusion surgery for adults with LBP, except as part of a randomized clinical trial. This survey aims to describe UK clinicians’ views about the suitability of patients for such a future trial, along with their views regarding equipoise for randomizing patients in a future clinical trial comparing lumbar spine fusion surgery to best conservative care (BCC; the FORENSIC-UK trial).

Methods

An online cross-sectional survey was piloted by the multidisciplinary research team, then shared with clinical professional groups in the UK who are involved in the management of adults with severe, persistent LBP. The survey had seven sections that covered the demographic details of the clinician, five hypothetical case vignettes of patients with varying presentations, a series of questions regarding the preferred management, and whether or not each clinician would be willing to recruit the example patients into future clinical trials.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 713 - 719
1 Jul 2024
Patel MS Shah S Elkazaz MK Shafafy M Grevitt MP

Aims

Historically, patients undergoing surgery for adolescent idiopathic scoliosis (AIS) have been nursed postoperatively in a critical care (CC) setting because of the challenges posed by prone positioning, extensive exposures, prolonged operating times, significant blood loss, major intraoperative fluid shifts, cardiopulmonary complications, and difficulty in postoperative pain management. The primary aim of this paper was to determine whether a scoring system, which uses Cobb angle, forced vital capacity (FVC), forced expiratory volume in one second (FEV1), and number of levels to be fused, is a valid method of predicting the need for postoperative critical care in AIS patients who are to undergo scoliosis correction with posterior spinal fusion (PSF).

Methods

We retrospectively reviewed all AIS patients who had undergone PSF between January 2018 and January 2020 in a specialist tertiary spinal referral centre. All patients were assessed preoperatively in an anaesthetic clinic. Postoperative care was defined as ward-based (WB) or critical care (CC), based on the preoperative FEV1, FVC, major curve Cobb angle, and the planned number of instrumented levels.


The Bone & Joint Journal
Vol. 106-B, Issue 6 | Pages 596 - 602
1 Jun 2024
Saarinen AJ Sponseller P Thompson GH White KK Emans J Cahill PJ Hwang S Helenius I

Aims

The aim of this study was to compare outcomes after growth-friendly treatment for early-onset scoliosis (EOS) between patients with skeletal dysplasias versus those with other syndromes.

Methods

We retrospectively identified 20 patients with skeletal dysplasias and 292 with other syndromes (control group) who had completed surgical growth-friendly EOS treatment between 1 January 2000 and 31 December 2018. We compared radiological parameters, complications, and health-related quality of life (HRQoL) at mean follow-up of 8.6 years (SD 3.3) in the dysplasia group and 6.6 years (SD 2.6) in the control group.


The Bone & Joint Journal
Vol. 106-B, Issue 3 | Pages 286 - 292
1 Mar 2024
Tang S Cheung JPY Cheung PWH

Aims

To systematically evaluate whether bracing can effectively achieve curve regression in patients with adolescent idiopathic scoliosis (AIS), and to identify any predictors of curve regression after bracing.

Methods

Two independent reviewers performed a comprehensive literature search in PubMed, Ovid, Web of Science, Scopus, and Cochrane Library to obtain all published information about the effectiveness of bracing in achieving curve regression in AIS patients. Search terms included “brace treatment” or “bracing,” “idiopathic scoliosis,” and “curve regression” or “curve reduction.” Inclusion criteria were studies recruiting patients with AIS undergoing brace treatment and one of the study outcomes must be curve regression or reduction, defined as > 5° reduction in coronal Cobb angle of a major curve upon bracing completion. Exclusion criteria were studies including non-AIS patients, studies not reporting p-value or confidence interval, animal studies, case reports, case series, and systematic reviews. The GRADE approach to assessing quality of evidence was used to evaluate each publication.


Bone & Joint Open
Vol. 4, Issue 11 | Pages 873 - 880
17 Nov 2023
Swaby L Perry DC Walker K Hind D Mills A Jayasuriya R Totton N Desoysa L Chatters R Young B Sherratt F Latimer N Keetharuth A Kenison L Walters S Gardner A Ahuja S Campbell L Greenwood S Cole A

Aims. Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS). Methods. UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination. Discussion. The primary outcome is ‘treatment failure’ (Cobb angle progression to 50° or more before skeletal maturity); skeletal maturity is at Risser stage 4 in females and 5 in males, or ‘treatment success’ (Cobb angle less than 50° at skeletal maturity). The comparison is on a non-inferiority basis (non-inferiority margin 11%). Participants are followed up every six months while in brace, and at one and two years after skeletal maturity. Secondary outcomes include the Scoliosis Research Society 22 questionnaire and measures of quality of life, psychological effects of bracing, adherence, anxiety and depression, sleep, satisfaction, and educational attainment. All data will be collected through the British Spine Registry. Cite this article: Bone Jt Open 2023;4(11):873–880


Bone & Joint Open
Vol. 4, Issue 9 | Pages 689 - 695
7 Sep 2023
Lim KBL Lee NKL Yeo BS Lim VMM Ng SWL Mishra N

Aims

To determine whether side-bending films in scoliosis are assessed for adequacy in clinical practice; and to introduce a novel method for doing so.

Methods

Six surgeons and eight radiographers were invited to participate in four online surveys. The generic survey comprised erect and left and right bending radiographs of eight individuals with scoliosis, with an average age of 14.6 years. Respondents were asked to indicate whether each bending film was optimal (adequate) or suboptimal. In the first survey, they were also asked if they currently assessed the adequacy of bending films. A similar second survey was sent out two weeks later, using the same eight cases but in a different order. In the third survey, a guide for assessing bending film adequacy was attached along with the radiographs to introduce the novel T1-45B method, in which the upper endplate of T1 must tilt ≥ 45° from baseline for the study to be considered optimal. A fourth and final survey was subsequently conducted for confirmation.


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 431 - 438
15 Mar 2023
Vendeuvre T Tabard-Fougère A Armand S Dayer R

Aims

This study aimed to evaluate rasterstereography of the spine as a diagnostic test for adolescent idiopathic soliosis (AIS), and to compare its results with those obtained using a scoliometer.

Methods

Adolescents suspected of AIS and scheduled for radiographs were included. Rasterstereographic scoliosis angle (SA), maximal vertebral surface rotation (ROT), and angle of trunk rotation (ATR) with a scoliometer were evaluated. The area under the curve (AUC) from receiver operating characteristic (ROC) plots were used to describe the discriminative ability of the SA, ROT, and ATR for scoliosis, defined as a Cobb angle > 10°. Test characteristics (sensitivity and specificity) were reported for the best threshold identified using the Youden method. AUC of SA, ATR, and ROT were compared using the bootstrap test for two correlated ROC curves method.


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 439 - 448
15 Mar 2023
Hong H Pan X Song J Fang N Yang R Xiang L Wang X Huang C

Aims

The prevalence of scoliosis is not known in patients with idiopathic short stature, and the impact of treatment with recombinant human growth hormone on those with scoliosis remains controversial. We investigated the prevalence of scoliosis radiologically in children with idiopathic short stature, and the impact of treatment with growth hormone in a cross-sectional and retrospective cohort study.

Methods

A total of 2,053 children with idiopathic short stature and 4,106 age- and sex-matched (1:2) children without short stature with available whole-spine radiographs were enrolled in the cross-sectional study. Among them, 1,056 with idiopathic short stature and 790 controls who had radiographs more than twice were recruited to assess the development and progression of scoliosis, and the need for bracing and surgery.


The Bone & Joint Journal
Vol. 105-B, Issue 2 | Pages 166 - 171
1 Feb 2023
Ragborg LC Dragsted C Ohrt-Nissen S Andersen T Gehrchen M Dahl B

Aims. Only a few studies have investigated the long-term health-related quality of life (HRQoL) in patients with an idiopathic scoliosis. The aim of this study was to investigate the overall HRQoL and employment status of patients with an idiopathic scoliosis 40 years after diagnosis, to compare it with that of the normal population, and to identify possible predictors for a better long-term HRQoL. Methods. We reviewed the full medical records and radiological reports of patients referred to our hospital with a scoliosis of childhood between April 1972 and April 1982. Of 129 eligible patients with a juvenile or adolescent idiopathic scoliosis, 91 took part in the study (71%). They were evaluated with full-spine radiographs and HRQoL questionnaires and compared with normative data. We compared the HRQoL between observation (n = 27), bracing (n = 46), and surgical treatment (n = 18), and between thoracic and thoracolumbar/lumbar (TL/L) curves. Results. The mean time to follow-up was 40.8 years (SD 2.6) and the mean age of patients was 54.0 years (SD 2.7). Of the 91 patients, 86 were female (95%) and 51 had a main thoracic curve (53%). We found a significantly lower HRQoL measured on all the Scoliosis Research Society 22r instrument (SRS-22r) subdomains (p < 0.001) with the exception of mental health, than in an age-matched normal population. Incapacity to work was more prevalent in scoliosis patients (21%) than in the normal population (11%). The median SRS-22r subscore was 4.0 (interquartile range (IQR) 3.3 to 4.4) for TL/L curves and 4.1 (IQR 3.8 to 4.4) for thoracic curves (p = 0.300). We found a significantly lower self-image score for braced (median 3.6 (IQR 3.0 to 4.0)) and surgically treated patients (median 3.6 (IQR 3.2 to 4.3)) than for those treated by observation (median 4.0 (IQR 4.1 to 4.8); p = 0.010), but no statistically significant differences were found for the remaining subdomains. Conclusion. In this long-term follow-up study, we found a significantly decreased HRQoL and capacity to work in patients with an idiopathic scoliosis 40 years after diagnosis. Cite this article: Bone Joint J 2023;105-B(2):166–171


The Bone & Joint Journal
Vol. 104-B, Issue 11 | Pages 1249 - 1255
1 Nov 2022
Williamson TK Passfall L Ihejirika-Lomedico R Espinosa A Owusu-Sarpong S Lanre-Amos T Schoenfeld AJ Passias PG

Aims

Postoperative complication rates remain relatively high after adult spinal deformity (ASD) surgery. The extent to which modifiable patient-related factors influence complication rates in patients with ASD has not been effectively evaluated. The aim of this retrospective cohort study was to evaluate the association between modifiable patient-related factors and complications after corrective surgery for ASD.

Methods

ASD patients with two-year data were included. Complications were categorized as follows: any complication, major, medical, surgical, major mechanical, major radiological, and reoperation. Modifiable risk factors included smoking, obesity, osteoporosis, alcohol use, depression, psychiatric diagnosis, and hypertension. Patients were stratified by the degree of baseline deformity (low degree of deformity (LowDef)/high degree of deformity (HighDef): below or above 20°) and age (Older/Younger: above or below 65 years). Complication rates were compared for modifiable risk factors in each age/deformity group, using multivariable logistic regression analysis to adjust for confounders.


The Bone & Joint Journal
Vol. 104-B, Issue 9 | Pages 1067 - 1072
1 Sep 2022
Helenius L Gerdhem P Ahonen M Syvänen J Jalkanen J Charalampidis A Nietosvaara Y Helenius I

Aims

The aim of this study was to evaluate whether, after correction of an adolescent idiopathic scoliosis (AIS), leaving out the subfascial drain gives results that are no worse than using a drain in terms of total blood loss, drop in haemoglobin level, and opioid consumption.

Methods

Adolescents (aged between 10 and 21 years) with an idiopathic scoliosis (major curve ≥ 45°) were eligible for inclusion in this randomized controlled noninferiority trial (n = 125). A total of 90 adolescents who had undergone segmental pedicle screw instrumentation were randomized into no-drain or drain groups at the time of wound closure using the sealed envelope technique (1:1). The primary outcome was a drop in the haemoglobin level during first three postoperative days. Secondary outcomes were 48-hour postoperative oxycodone consumption and surgical complications.


The Bone & Joint Journal
Vol. 104-B, Issue 4 | Pages 495 - 503
1 Apr 2022
Wong LPK Cheung PWH Cheung JPY

Aims

The aim of this study was to assess the ability of morphological spinal parameters to predict the outcome of bracing in patients with adolescent idiopathic scoliosis (AIS) and to establish a novel supine correction index (SCI) for guiding bracing treatment.

Methods

Patients with AIS to be treated by bracing were prospectively recruited between December 2016 and 2018, and were followed until brace removal. In all, 207 patients with a mean age at recruitment of 12.8 years (SD 1.2) were enrolled. Cobb angles, supine flexibility, and the rate of in-brace correction were measured and used to predict curve progression at the end of follow-up. The SCI was defined as the ratio between correction rate and flexibility. Receiver operating characteristic (ROC) curve analysis was carried out to assess the optimal thresholds for flexibility, correction rate, and SCI in predicting a higher risk of progression, defined by a change in Cobb angle of ≥ 5° or the need for surgery.


The Bone & Joint Journal
Vol. 104-B, Issue 2 | Pages 265 - 273
1 Feb 2022
Mens RH Bisseling P de Kleuver M van Hooff ML

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).


Aims. To provide normative data that can assess spinal-related disability and the prevalence of back or leg pain among adults with no spinal conditions in the UK using validated questionnaires. Methods. A total of 1,000 participants with equal sex distribution were included and categorized in five age groups: 20 to 29, 30 to 39, 40 to 49, 50 to 59, and 60 to 69 years. Individuals with spinal pathologies were excluded. Participants completed the Scoliosis Research Society-22 (SRS-22r), visual analogue scale (VAS) for back/leg pain, and the EuroQol five-dimension index (EQ-5D/VAS) questionnaires, and disclosed their age, sex, and occupation. They were also categorized in five professional groups: doctors, nurses, allied health professionals, office workers, and manual workers. Results. The mean age of all participants was 43.8 years (20 to 69). There was no difference in the SRS-22r, EQ-5D, or VAS scores among male and female participants (p > 0.05). There was incremental decrease in SRS-22r total scores as the age increased. The mean EQ-5D index score (0.84) ranged little across the age groups (0.72 to 0.91) but reduced gradually with increasing age. There was difference between the SRS-22r total score (4.51), the individual domain scores, and the EQ-5D score (index: 0.94 and VAS: 89) for the doctors’ group compared to all other occupational categories (p < 0.001). Doctors had a younger mean age of participants, which may explain their improved spinal health. There was no difference in the total or sub-domain SRS-22r and EQ-5D scores between the other four occupational groups. Conclusion. This study provides the first normative data for the SRS-22r, EQ-5D, and VAS for back/leg pain questionnaires among adults in the UK. We recorded an excellent correlation between the three assessment tools with individuals who reported less back and leg pain having better quality of life and greater function. The participants’ age, rather than their sex or profession, appears to be the major determinant for spinal health and quality of life. Cite this article: Bone Jt Open 2022;3(2):130–134


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 103 - 111
1 Jan 2022
Li J Hu Z Qian Z Tang Z Qiu Y Zhu Z Liu Z

Aims

The outcome following the development of neurological complications after corrective surgery for scoliosis varies from full recovery to a permanent deficit. This study aimed to assess the prognosis and recovery of major neurological deficits in these patients, and to determine the risk factors for non-recovery, at a minimum follow-up of two years.

Methods

A major neurological deficit was identified in 65 of 8,870 patients who underwent corrective surgery for scoliosis, including eight with complete paraplegia and 57 with incomplete paraplegia. There were 23 male and 42 female patients. Their mean age was 25.0 years (SD 16.3). The aetiology of the scoliosis was idiopathic (n = 6), congenital (n = 23), neuromuscular (n = 11), neurofibromatosis type 1 (n = 6), and others (n = 19). Neurological function was determined by the American Spinal Injury Association (ASIA) impairment scale at a mean follow-up of 45.4 months (SD 17.2). the patients were divided into those with recovery and those with no recovery according to the ASIA scale during follow-up.


The Bone & Joint Journal
Vol. 103-B, Issue 8 | Pages 1400 - 1404
1 Aug 2021
Sim FCJ Birley E Khan AL Loughenbury PR Millner P

Aims

The aim of this study was to determine whether there is an increased prevalence of scoliosis in patients who have suffered from a haematopoietic malignancy in childhood.

Methods

Patients with a history of lymphoma or leukaemia with a current age between 12 and 25 years were identified from the regional paediatric oncology database. The medical records and radiological findings were reviewed, and any spinal deformity identified. The treatment of the malignancy and the spinal deformity, if any, was noted.


The Bone & Joint Journal
Vol. 103-B, Issue 7 | Pages 1309 - 1316
1 Jul 2021
Garg B Bansal T Mehta N

Aims. To describe the clinical, radiological, and functional outcomes in patients with isolated congenital thoracolumbar kyphosis who were treated with three-column osteotomy by posterior-only approach. Methods. Hospital records of 27 patients with isolated congenital thoracolumbar kyphosis undergoing surgery at a single centre were retrospectively analyzed. All patients underwent deformity correction which involved a three-column osteotomy by single-stage posterior-only approach. Radiological parameters (local kyphosis angle (KA), thoracic kyphosis (TK), lumbar lordosis (LL), pelvic tilt (PT), sacral slope (SS), C7 sagittal vertical axis (C7 SVA), T1 slope, and pelvic incidence minus lumbar lordosis (PI-LL)), functional scores, and clinical details of complications were recorded. Results. The mean age of the study population was 13.9 years (SD 6.4). The apex of deformity was in thoracic, thoracolumbar, and lumbar spine in five, 14, and eight patients, respectively. The mean operating time was 178.4 minutes (SD 38.5) and the mean operative blood loss was 701.8 ml (SD 194.4). KA (preoperative mean 70.8° (SD 21.6°) vs final follow-up mean 24.7° (SD 18.9°); p < 0.001) and TK (preoperative mean -1.48° (SD 41.23°) vs final follow-up mean 24.28° (SD 17.29°); p = 0.005) underwent a significant change with surgery. Mean Scoliosis Research Society (SRS-22r) score improved after surgical correction (preoperative mean 3.24 (SD 0.37) vs final follow-up mean 4.28 (SD 0.47); p < 0.001) with maximum improvement in self-image and mental health domains. The overall complication rate was 26%, including two neurological and five non-neurological complications. Permanent neurological deficit was noted in one patient. Conclusion. Deformity correction employing three-column osteotomies by a single-stage posterior-only approach is safe and effective in treating isolated congenital thoracolumbar kyphosis. Cite this article: Bone Joint J 2021;103-B(7):1309–1316


The Bone & Joint Journal
Vol. 103-B, Issue 6 | Pages 1133 - 1141
1 Jun 2021
Tsirikos AI Wordie SJ

Aims

To report the outcome of spinal deformity correction through anterior spinal fusion in wheelchair-bound patients with myelomeningocele.

Methods

We reviewed 12 consecutive patients (7M:5F; mean age 12.4 years (9.2 to 16.8)) including demographic details, spinopelvic parameters, surgical correction, and perioperative data. We assessed the impact of surgery on patient outcomes using the Spina Bifida Spine Questionnaire and a qualitative questionnaire.


The Bone & Joint Journal
Vol. 103-B, Issue 3 | Pages 536 - 541
1 Mar 2021
Ferlic PW Hauser L Götzen M Lindtner RA Fischler S Krismer M

Aims

The aim of this retrospective study was to compare the correction achieved using a convex pedicle screw technique and a low implant density achieved using periapical concave-sided screws and a high implant density. We hypothesized that there would be no difference in outcome between the two techniques.

Methods

We retrospectively analyzed a series of 51 patients with a thoracic adolescent idiopathic scoliosis. There were 26 patients in the convex pedicle screw group who had screws implanted periapically (Group 2) and a control group of 25 patients with bilateral pedicle screws (Group 1). The patients’ charts were reviewed and pre- and postoperative radiographs evaluated. Postoperative patient-reported outcome measures (PROMs) were recorded.