Ankylosing spondylitis patients commencing biologic therapy have high baseline levels of comorbidity: a report from the Australian Rheumatology Association Database

Aims: To compare the baseline characteristics of a population-based cohort of patients with ankylosing spondylitis (AS) commencing biological therapy to the reported characteristics of bDMARD randomised controlled trials (RCTs) participants.
Methods: Descriptive analysis of AS participants in the Australian Rheumatology Association Database (ARAD) who were commencing bDMARD therapy.
Results: Up to December 2008, 389 patients with AS were enrolled in ARAD. 354 (91.0%) had taken bDMARDs at some time, and 198 (55.9%) completed their entry questionnaire prior to or within 6 months of commencing bDMARDs. 131 (66.1%) had at least one comorbid condition, and 24 (6.8%) had a previous malignancy (15 nonmelanoma skin, 4 melanoma, 2 prostate, 1 breast, cervix, and bowel). Compared with RCT participants, ARAD participants were older, had longer disease duration and higher baseline disease activity.
Conclusions: AS patients commencing bDMARDs in routine care are significantly different to RCT participants and have significant baseline comorbidities.

Ambulance call triage outcomes for patients reporting pain : a retrospective cross-sectional analysis of pain score versus traige level

Objective: To identify any association between the response priority code generated during calls to the ambulance communication centre and patient reports of pain severity.

Methods: A retrospective analysis of patient care records was undertaken for all patients transported by paramedics over a 7-day period. The primary research interest was the association between the response code allocated at the time of telephone triage and the initial pain severity score recorded using a numeric rating scale (NRS). Univariate and multivariate logistic regression methods were used to analyse the association between the response priority variable and explanatory variables.

Results: There were 1246 cases in which both an initial pain score using the NRS and a response code were recorded. Of these cases, 716/1246 (57.5%) were associated with a code 1 ("time-critical") response. After adjusting for gender, age, cause of pain and duration of pain, a multivariate logistic regression analysis found no significant change in the odds of a patient in pain receiving a time-critical response compared with patients who had no pain, regardless of their initial pain score (NRS 1–3, odds ratio (OR) 1.11, 95% CI 0.7 to 1.8; NRS 4–7, OR 1.12, 95% CI 0.7 to 1.8; NRS 8–10, OR 0.84, 95% CI 0.5 to 1.4).

Conclusion: The severity of pain experienced by the patient appeared to have no influence on the priority (urgency) of the dispatch response. Triage systems used to prioritise ambulance calls and decide the urgency of response or type of referral options should consider pain severity to facilitate timely and humane care.

Return to pre-injury health status and function 12 months after hospitalisation for sport and active recreation related orthopaedic injury

Background Hospitalised sport and active recreation injuries can have serious long-term consequences. Despite this, few studies have examined the long-term outcomes of these injuries. The purpose of this study was to establish whether patients hospitalised with orthopaedic sport and active recreation injuries, have returned to their pre-injury levels of health status and function, 12 months post injury and identify factors associated with poor outcomes. The present work was a cohort study with retrospective assessment of pre-injury status and prospective assessment of outcome at 12 months post injury.

Methods Adults with orthopaedic sport and active recreation injuries, captured by the Victorian Orthopaedic Trauma Outcomes Registry were recruited to the study. Pre-injury and 12-month outcomes were assessed using the 36-item Short Form Health Survey (SF-36) and the extended Glasgow Outcome Scale. Differences in pre-injury and post-injury SF-36 scores were examined and demographic, injury, hospital and physical activity variables were assessed for associations with outcome using multivariate linear regression.

Results Of the 324 participants 98% were followed-up at 12 months post injury. At 12 months, participants reported a mean 7.0-point reduction in physical health (95% CI 5.8 to 7.8) and a 2.5-point reduction in mental health (95% CI 1.2 to 3.0), with 58% (95% CI 52.6% to 63.4%) reporting reduced function. Sporting group (p=0.001), Injury Severity Score >15 (p=0.007) and high pre-injury vigorous activity levels (p=0.04), were related to poorer physical health outcomes.

Conclusions At 12 months post injury, most participants reported large reductions in physical health and reduced function. This information is important for furthering our understanding of the burden of sport and active recreation injury and setting priorities for treatment and rehabilitation.

Interobserver reliability of radial head fracture classification : two-dimensional compared with three-dimensional CT

Background: The Broberg and Morrey modification of the Mason classification of radial head fractures has substantial interobserver variation. This study used a large web-based collaborative of experienced orthopaedic surgeons to test the hypothesis that three-dimensional reconstructions of computed tomography (CT) scans improve the interobserver reliability of the classification of radial head fractures according to the Broberg and Morrey modification of the Mason classification.

Methods: Eighty-five orthopaedic surgeons evaluated twelve radial head fractures. They were randomly assigned to review either radiographs and two-dimensional CT scans or radiographs and three-dimensional CT images to determine the fracture classification, fracture characteristics, and treatment recommendations. The kappa multirater measure (κ) was calculated to estimate agreement between observers.

Results: Three-dimensional CT had moderate agreement and two-dimensional CT had fair agreement among observers for the Broberg and Morrey modification of the Mason classification, a difference that was significant. Observers assessed seven fracture characteristics, including fracture line, comminution, articular surface involvement, articular step or gap of ≥2 mm, central impaction, recognition of more than three fracture fragments, and fracture fragments too small to repair. There was a significant difference in kappa values between three-dimensional CT and two-dimensional CT for fracture fragments too small to repair, recognition of three fracture fragments, and central impaction. The difference between the other four fracture characteristics was not significant. Among treatment recommendations, there was fair agreement for both three-dimensional CT and two-dimensional CT.

Conclusions: Although three-dimensional CT led to some small but significant decreases in interobserver variation, there is still considerable disagreement regarding classification and characterization of radial head fractures. Three-dimensional CT may be insufficient to optimize interobserver agreement.

If a trauma patient is tachycardic, should we call for a counsellor?

BACKGROUND: It has been suggested in the literature that raised heart rate in the early period after trauma is associated with the development of post-traumatic psychopathology, but little account has been taken of the potential confounding effect of injury severity.

MATERIALS AND METHODS: A cohort of 154 patients, studied as part of a wider investigation of trauma outcomes, was included. Initial heart rate in the accident & emergency department, and injury severity score and new injury severity scores were recorded. Patients completed the General Health Questionnaire (GHQ-28) as a measure of psychopathology at presentation and again at two- and six-month follow-up.

RESULTS: There was no relationship between psychopathology at presentation and initial heart rate or injury severity. Raised heart rate was associated with post-traumatic psychopathology at two months but not at six months. When the potential confounding effect of injury severity was controlled for, there was no independent correlation between heart rate and post-traumatic psychopathology. Injury severity score and new injury severity scores were strongly associated with GHQ-28 caseness.

CONCLUSION: Post-traumatic tachycardia is not associated with development of psychopathology, but injury severity is. Previous studies that have suggested a link between tachycardia and development of psychopathology are flawed because they have not considered the confounding effect of severity of injury.

Complications associated with operative fixation of acute midshaft clavicle fractures

The aim of this study was to review the complication rate and profile associated with surgical fixation of acute midshaft clavicle fracture in a large cohort of patients treated in a level I trauma centre.Patients and methods: We identified all patients who underwent surgical treatment of acute midshaft clavicle fracture between 2002 and 2010. The study group consisted of 138 fractures (134 patients). There were 107 males (78%) and 31 females (22%) and median age of 35 years (IQR 24-45). The most common mechanism of injury was a road traffic accident (78%). Sixty percent (n = 83) had an injury severity score of ≥ 15 indicating major trauma. The most common fracture type (75%) was simple or wedge comminuted (2B1) according to the Edinburgh classification. The median interval between the injury and operation was 3 days (IQR 1-6). Plate fixation was performed in 110 fractures (80%) and intramedullary fixation was performed in 28 fractures (20%). There were 85 males and 25 females in the plate fixation group with median age of 35 years (IQR: 25-45) There were 22 males and 6 females in intramedullary fixation group with median age of 31 years (IQR 24-42 years). Statistical analysis was performed using Independent sample t-test, Mann-Whitney test, and Chi-square test. Significant P-value was < 0.05.Results: The overall incidence of complication was 14.5% (n = 20). The overall nonunion rate 6%. Post operative wound infection occurred in 3.6% of cases. The incidence of complication associated with plate fixation was 10% (11 of 110 cases) compared to 32% associated with intramedullary fixation (9 of 28 cases) (P = 0.003). Thirty five percent of complications were related to inadequate surgical technique and potentially avoidable. Symptomatic hardware requiring removal occurred in 23% (n = 31) of patients. Symptomatic metalware was more frequent after plate fixation compared to intramedullary fixation (26% vs 7%, P = 0.03).Conclusions: Intramedullary fixation of midshaft clavicle fracture is associated with higher incidence of complications. Plate fixation is associated with a higher rate of symptomatic metalware requiring removal compared to intramedullary fixation. Approximately one in three complications may be avoided by attention to adequate surgical technique.

The VISA-A questionnaire: a valid and reliable index of the clinical severity of Achilles tendinoplasty

Background: There is no disease specific, reliable, and valid clinical measure of Achilles tendinopathy. Objective: To develop and test a questionnaire based instrument that would serve as an index of severity of Achilles tendinopathy. Methods: Item generation, item reduction, item scaling, and pretesting were used to develop a questionnaire to assess the severity of Achilles tendinopathy. The final version consisted of eight  questions that measured the domains of pain, function in daily living, and sporting activity. Results range from 0 to 100, where 100 represents the perfect score. Its validity and reliability were then tested in a population of non-surgical patients with Achilles tendinopathy (n = 45), presurgical patients with Achilles tendinopathy (n = 14), and two normal control populations (total n = 87). Results: The VISA-A questionnaire had good test-retest (r = 0.93), intrarater (three tests, r = 0.90), and interrater (r = 0.90) reliability as well as good stability when compared one week apart (r = 0.81). The mean (95% confidence interval) VISA-A score in the non-surgical patients was 64 (59–69), in presurgical patients 44 (28–60), and in control subjects it exceeded 96 (94–99). Thus the VISA-A score was higher in non-surgical than presurgical patients (p = 0.02) and higher in control subjects than in both patient populations (p<0.001). Conclusions: The VISA-A questionnaire is reliable and displayed construct validity when means were compared in patients with a range of severity of Achilles tendinopathy and control subjects. The continuous numerical result of the VISA-A questionnaire has the potential to provide utility in both the clinical setting and research. The test is not designed to be diagnostic. Further studies are needed to determine whether the VISA-A score predicts prognosis.

Clinical measurement of muscle tone using a velocity-corrected modified ashworth scale

Objective: To develop a new form of the modified Ashworth scale (MAS) for muscle-tone assessment that combines the MAS score with the passive muscle-stretching velocity during the assessment of muscle tone, resulting in a measure that has higher intertester reliability than the MAS.

Design: Twanty-two volunteer subjects with spinal cord injuries at a tertiary care outpatient and inpatient spinal cord injury rehabilitation center affiliated with a university were recruited for this study.

Results: A decision tree in which V-MAS scores were obtained was developed. The data obtained from three independent raters, when adjusted by means of the V-MAS, showed an excellent interrater reliability.

Conclusions: Results indicated that the V-MAS is a more reliable measure. In addition, the resulting units of the V-MAS, ranging from 0 to 1, are of the same form as pendulum test data. The V-MAS method is quite simple to use because the rater need only measure the angular range and duration of the passive movement to calculate average velocity during the MAS assessment in addition to the normal MAS rating of muscle tone.

Frequency, severity and effect of life of physical symptoms experienced during pregnancy

This study aimed to: 1) describe the number, frequency, severity of discomfort and effect of symptoms on life of 29 physical symptoms women experienced at 15 to 25 weeks of gestation; 2) explore whether experiencing this group of physical symptoms more frequently and intensely was associated with a higher score of depressive symptoms and lower self-esteem; (3) examine whether discomfort and effect ratings aided prediction of well being over and above symptom frequency; and (4) investigate which individual physical symptoms contributed most to predicting depressive symptoms and self-esteem. Pregnant women (n = 215) completed the Beck Depression Inventory, Rosenberg Self-Esteem Scale, and a physical symptoms questionnaire. Frequency, discomfort, and the effect of physical symptoms all consistently correlated with higher scores for depressive symptoms, but less consistently with lower self-esteem. Discomfort and the effect of symptoms predicted variance in depressive symptoms after accounting for symptom frequency. Higher frequency, more discomfort, and the effect of fatigue and effect of flatulence were related to depressive symptoms. Relationships between pregnancy-related physical symptoms, depressive symptoms, and low self-esteem suggest that when women report any of these constellation of factors, further screening is indicated. A comprehensive assessment of physical symptoms includes frequency, discomfort, and effect on life.

DSM-5 mixed specifier for manic episodes: evaluating the effect of depressive features on severity and treatment outcome using asenapine clinical trial data

Background:
To describe the frequency of mixed specifier as proposed in DSM-5 in bipolar I patients with manic episodes, and to evaluate the effect of mixed specifier on symptom severity and treatment outcome.

Methods:
This post-hoc analysis used proxies for DSM-5 mixed features specifier by using MADRS or PANSS items.

Results:
Of the 960 patients analysed, 34%, 18% and 4.3% of patients, respectively, had ≥3 depressive features with mild (score ≥1 for MADRS items and ≥2 for PANSS item), moderate (score ≥2 MADRS, ≥3 PANSS) and severe (score ≥3 MADRS, ≥4 PANSS) symptoms. In patients with ≥3 depressive features and independent of treatment: MADRS remission (score ≤12) rate decreased with increasing severity (61–43%) and YMRS remission (score ≤12) was similar for mild and moderate patients (36–37%), but higher for severe (54%). In asenapine-treated patients, the MADRS remission rate was stable regardless of baseline depressive symptom severity (range 64–67%), whereas remission decreased with increasing severity with olanzapine (63–38%) and placebo (49–25%). Reduction in YMRS was significantly greater for asenapine compared with placebo at day 2 across the 3 severity cut-offs and continued to decrease throughout the treatment period. The difference between olanzapine and placebo was statistically significant in mild and moderate patients.

Limitations:
Results are from post-hoc analyses.

Conclusions:
These analyses support the validity of proposed DSM-5 criteria. They confirm that depressive features are frequent in bipolar patients with manic episodes. With increasing baseline severity of depressive features, treatment outcome was poorer with olanzapine and placebo, but remained stable with asenapine.

Characterizing problematic hypoglycaemia: iterative design and preliminary psychometric validation of the Hypoglycaemia Awareness Questionnaire (HypoA-Q)

AIMS: To design and conduct preliminary validation of a measure of hypoglycaemia awareness and problematic hypoglycaemia, the Hypoglycaemia Awareness Questionnaire.

METHODS: Exploratory and cognitive debriefing interviews were conducted with 17 adults (nine of whom were women) with Type 1 diabetes (mean ± sd age 48±10 years). Questionnaire items were modified in consultation with diabetologists/psychologists. Psychometric validation was undertaken using data from 120 adults (53 women) with Type 1 diabetes (mean ± sd age 44±16 years; 50% with clinically diagnosed impaired awareness of hypoglycaemia), who completed the following questionnaires: the Hypoglycaemia Awareness Questionnaire, the Gold score, the Clarke questionnaire and the Problem Areas in Diabetes questionnaire.

RESULTS: Iterative design resulted in 33 items eliciting answers on awareness of hypoglycaemia when awake/asleep and hypoglycaemia frequency, severity and impact (healthcare utilization). Psychometric analysis identified three subscales reflecting 'impaired awareness', 'symptom level' and 'symptom frequency'. Convergent validity was indicated by strong correlations between the impaired awareness subscale and existing measures of awareness: (Gold: rs =0.75, P<0.01; Clarke: rs =0.76, P<0.01). Divergent validity was indicated by weaker correlations with diabetes-related distress (Problem Areas in Diabetes: rs =0.25, P<0.01) and HbA1c (rs =-0.05, non-significant). The impaired awareness subscale and other items discriminated between those with impaired and intact awareness (Gold score). The impaired awareness subscale and other items contributed significantly to models explaining the occurrence of severe hypoglycaemia and hypoglycaemia when asleep.

CONCLUSIONS: This preliminary validation shows the Hypoglycaemia Awareness Questionnaire has robust face and content validity; satisfactory structure; internal reliability; convergent, divergent and known groups validity. The impaired awareness subscale and other items contribute significantly to models explaining recall of severe and nocturnal hypoglycaemia. Prospective validation, including determination of a threshold to identify impaired awareness, is now warranted.

A preliminary adaptation of the Problem Gambling Severity Index for Indigenous Australians: internal reliability and construct validity

Objective: This paper describes the process employed to adapt the Problem Gambling Severity Index (PGSI) for use with Indigenous Australian populations.Methods: This study comprised a two-stage process: an initial consultation with Indigenous health workers, informing the textual and conceptual adaptation of items, followed by trial of the adjusted instrument with Indigenous community members (n=301).Results: Internal reliability was demonstrated: Australian Indigenous Problem Gambling Index (AIPGI) Cronbach's alpha α = 0.92 (Original PGSI, α = 0.84). Item-rest correlations confirmed that responses to items were consistent and related to the total score of remaining items. The AIPGI could predict gambling severity based on gambling frequency, when controlling for age and gender (OR=1.28, 95%CI 1.17–1.40).Conclusions: The adapted instrument is accessible to a cross-section of Indigenous Australians and has demonstrated properties of reliability and validity. An extended trial is needed to test the application of the instrument to a broader Indigenous audience and to further explore and confirm psychometric properties of the adapted instrument.Implications: This study introduces a culturally adapted tool for measuring rates of disordered gambling among Indigenous Australians.

Retinal tissue thickness is reduced in diabetic peripheral neuropathy

AIM: To investigate the relationship between diabetic peripheral neuropathy (DPN) and retinal tissue thickness.

METHODS: Full retinal thickness in the central retinal, parafoveal, and perifoveal zones and thickness of the ganglion cell complex and retinal nerve fiber layer (RNFL) were assessed in 193 individuals (84 with type 1 diabetes, 67 with type 2 diabetes, and 42 healthy controls) using spectral domain optical coherence tomography. Among those with diabetes, 44 had neuropathy defined using a modified neuropathy disability score recorded on a 0-10 scale. Multiple regression analysis was performed to investigate the relationship between diabetic neuropathy and retinal tissue thickness, adjusted for the presence of diabetic retinopathy (DR), age, sex, duration of diabetes, and HbA1c levels.

RESULTS: In individuals with diabetes, perifoveal thickness was inversely related to the severity of neuropathy (p < 0.05), when adjusted for age, sex, duration of diabetes, and HbA1c levels. DR was associated with reduced thickness in parafovea (p < 0.01). The RNFL was thinner in individuals with greater degrees of neuropathy (p < 0.04).

CONCLUSIONS: DPN is associated with structural compromise involving several retinal layers. This compromise may represent a threat to visual integrity and therefore warrants examination of functional correlates.

Efficacy and safety of very early mobilisation within 24 h of stroke onset (AVERT): a randomised controlled trial

Background Early mobilisation after stroke is thought to contribute to the eff ects of stroke-unit care; however, the intervention is poorly defined and not underpinned by strong evidence. We aimed to compare the effectiveness of frequent, higher dose, very early mobilisation with usual care after stroke.MethodsWe did this parallel-group, single-blind, randomised controlled trial at 56 acute stroke units in five countries. Patients (aged ≥18 years) with ischaemic or haemorrhagic stroke, first or recurrent, who met physiological criteriawere randomly assigned (1:1), via a web-based computer generated block randomisation procedure (block size of six), to receive usual stroke-unit care alone or very early mobilisation in addition to usual care. Treatment with recombinant tissue plasminogen activator was allowed. Randomisation was stratified by study site and stroke severity. Patients, outcome assessors, and investigators involved in trial and data management were masked to treatment allocation. The primary outcome was a favourable outcome 3 months after stroke, defined as a modified Rankin Scale score of 0–2. We did analysis on an intention-to-treat basis. The trial is registered with the Australian New Zealand Clinical Trials Registry, number ACTRN12606000185561.FindingsBetween July 18, 2006, and Oct 16, 2014, we randomly assigned 2104 patients to receive either very early mobilisation (n=1054) or usual care (n=1050); 2083 (99%) patients were included in the 3 month follow-up assessment. 965 (92%) patients were mobilised within 24 h in the very early mobilisation group compared with 623 (59%) patients in the usual care group. Fewer patients in the very early mobilisation group had a favourable outcome than those in the usual care group (n=480 [46%] vs n=525 [50%]; adjusted odds ratio [OR] 0·73, 95% CI 0·59–0·90; p=0·004). 88 (8%) patients died in the very early mobilisation group compared with 72 (7%) patients in the usual care group (OR 1·34, 95% CI 0·93–1·93, p=0·113). 201 (19%) patients in the very early mobilisation group and 208 (20%) of those in the usual care group had a non-fatal serious adverse event, with no reduction in immobility-related complications with very early mobilisation.InterpretationFirst mobilisation took place within 24 h for most patients in this trial. The higher dose, very early mobilisation protocol was associated with a reduction in the odds of a favourable outcome at 3 months. Early mobilisation after stroke is recommended in many clinical practice guidelines worldwide, and our findings should affect clinical practice by refi ning present guidelines; however, clinical recommendations should be informed by future analyses of dose–response associations.