Five-year outcomes of fractionated stereotactic body radiotherapy for oligometastatic prostate cancer from the TRANSFORM phase II trial.

Metastasis-directed therapy (MDT) for oligometastatic prostate cancer (PCa), including stereotactic body radiotherapy (SBRT), has shown promise but is still considered investigational. This is the 5-year analysis of the TRANSFORM trial, the largest prospective cohort of men with oligometastatic PCa treated with SBRT-based MDT. The primary endpoint was 5-year treatment escalation-free survival (TE-FS), defined as freedom from any new cancer therapy other than further SBRT. In total, 199 men received SBRT; 76.4% were hormone-naïve at baseline. The rate of 5-year TE-FS was 21.7% (95% confidence interval [CI]: 15.7%-28.7%) overall and 25.4% (95% CI: 18.1%-33.9%) in the hormone-naïve subgroup. The subgroups with International Society of Urological Pathology Grade Groups 4-5 disease (hazard ratio [HR] = 1.48, 95% CI: 1.05-2.01, p = .026), a higher baseline prostate-specific antigen (PSA) (HR = 1.06, 95% CI: 1.03-1.09, p < .001) and those who received prior androgen deprivation therapy (ADT) (HR = 2.13, 95% CI: 1.40-3.26, p < .001), were at greater risk of treatment escalation. Outcomes for participants with four or five initial lesions were comparable to those with one to three lesions. At last follow-up, 18.9% (95% CI: 13.2%-25.7%) of participants were free from treatment escalation (median follow-up of 67.9 months) and two participants had an undetectable PSA level. No treatment-related grade three or higher adverse events were reported. The findings of this study demonstrate that SBRT-based MDT is an effective option for delaying systemic treatment escalation in the context of oligometastatic PCa. Future randomised trials comparing SBRT-based MDT to standard-of-care ADT-based approaches are required to evaluate the impact of delaying ADT on survival.

When stroke survivors' self-ratings are inconsistent with the ratings of others: a cohort study examining biopsychosocial factors associated with impaired self-awareness of functional abilities.

Background Stroke survivors' self-ratings of functional abilities are often inconsistent with ratings assigned by others (e.g. clinicians), a phenomenon referred to as 'impaired self-awareness' (ISA). There is limited knowledge of the biopsychosocial contributors and consequences of post-stroke ISA measured across the rehabilitation journey. This multi-site cohort study explored biopsychosocial correlates of ISA during subacute rehabilitation (inpatient) and at 4 months post-discharge (community-dwelling). Methods Forty-five subacute stroke survivors participated (Age M (s.d.) = 71.5 (15.6), 56% female), and 38 were successfully followed-up. Self-assessments were compared to those of an independent rater (occupational therapist, close other) to calculate ISA at both time points. Survivors and raters completed additional cognitive, psychological and functional measures. Results Multivariate regression (multiple outcomes) identified associations between ISA during inpatient admission and poorer outcomes at follow-up, including poorer functional cognition, participation restriction, caregiver burden, and close other depression and anxiety. Regression models applied cross-sectionally, including one intended for correlated predictors, indicated associations between ISA during inpatient admission and younger age, male sex, poorer functional cognition, poorer rehabilitation engagement and less frequent use of non-productive coping (adjusted R 2 = 0.60). ISA at community follow-up was associated with poorer functional cognition and close other anxiety (adjusted R 2 = 0.66). Conclusions Associations between ISA and poorer outcomes across the rehabilitation journey highlight the clinical importance of ISA and the value of assessment and management approaches that consider the potential influence of numerous biological and psychosocial factors on ISA. Future studies should use larger sample sizes to confirm these results and determine the causal mechanisms of these relationships.

Considering the Importance of Personal and Injury Factors Influencing Outcome After Traumatic Brain Injury.

OBJECTIVE: Given the high variability in traumatic brain injury (TBI) outcomes and relative lack of examination of the influence of noninjury factors on outcome, this study aimed to examine factors associated with functional outcome at 1 and 2 years after moderate to severe TBI, including both preinjury and injury-related factors. DESIGN: Observational cohort study. SETTING: Inpatient hospital recruitment with outpatient follow-up at 1 and 2 years post injury. PARTICIPANTS: Individuals with moderate to severe TBI were recruited prospectively into a Longitudinal Head Injury Outcome Study. Of the eligible 3253 individuals who were eligible, 1899 participants consented to the study (N=1899). MAIN OUTCOME MEASURE: Functional outcome was measured using the Glasgow Outcome Scale-Extended (GOS-E). RESULTS: 1476 participants (73.6% males) and 1365 participants (73% males) completed the GOS-E at 1 and 2 years post injury. They had a mean age at injury of 40 years and mean duration of post-traumatic amnesia (PTA) of 26 days. Good recovery, representing return to previous activities on the GOS-E (score 7-8), was present in 31% of participants at 1 year post injury and 33.5% at 2 years post injury. When predictor variables were entered into regression together, good outcome was significantly associated with not being from a culturally and linguistically diverse background and not having preinjury mental health or alcohol treatment, shorter PTA duration, and absence of limb injuries at both 1 and 2 years; higher education was also a significant predictor at 1 year post injury. CONCLUSIONS: Alongside consideration of injury severity, understanding and addressing preinjury factors is important to maximize outcomes.

The impact of age on outcome 2 years after traumatic brain injury: Case control study.

BACKGROUND: Age is associated with outcome after traumatic brain injury (TBI). However, there are mixed findings across outcome domains and most studies lack controls. OBJECTIVES: This cross-sectional study examined the association between age group (15-24 years, 25-34 years, 35-44 years, 45-54 years, 55-64 years, and 65 years or more) and outcomes 2 years after TBI in independence in daily activities, driving, public transportation use, employment, leisure activities, social integration, relationships and emotional functioning, relative to healthy controls. It was hypothesized that older individuals with TBI would have significantly poorer outcomes than controls in all domains except anxiety and depression, for which it was expected they would show better outcomes. Global functional outcome (measured using the Glasgow Outcome Scale-Extended) was also examined, and we hypothesized that older adults would have poorer outcomes than younger adults. METHODS: Participants were 1897 individuals with TBI (mean, SD age 36.7, 17.7 years) who completed measures 2 years post-injury and 110 healthy controls (age 38.3, 17.5 years). RESULTS: Compared to controls, individuals with TBI were less independent in most activities of daily living, participated less in leisure activities and employment, and were more socially isolated, anxious and depressed (p < 0.001). Those who were older in age were disproportionately less likely to be independent in light domestic activities, shopping and driving; and participated less in occupational activities relative to controls. Functional outcome was significantly higher in the youngest age group than in all older age groups (p < 0.001), but the younger groups were more likely to report being socially isolated (p < 0.001), depressed (p = 0.005) and anxious (p = 0.02), and less likely to be married or in a relationship (p < 0.001). CONCLUSION: A greater focus is needed on addressing psychosocial issues in younger individuals with TBI, whereas those who are older may require more intensive therapy to maximise independence in activities of daily living and return to employment.

Sleep Disturbance During Post-Traumatic Amnesia and Early Recovery After Traumatic Brain Injury.

After moderate to severe traumatic brain injury (TBI), sleep disturbance commonly emerges during the confused post-traumatic amnesia (PTA) recovery stage. However, the evaluation of early sleep disturbance during PTA, its recovery trajectory, and influencing factors is limited. This study aimed to evaluate sleep outcomes in patients experiencing PTA using ambulatory gold-standard polysomnography (PSG) overnight and salivary endogenous melatonin (a hormone that influences the sleep-wake cycle) assessment at two time-points. The relationships between PSG-derived sleep-wake parameters and PTA symptoms (i.e., agitation and cognitive disturbance) were also evaluated. In a patient subset, PSG was repeated after PTA had resolved to assess the trajectory of sleep disturbance. Participants with PTA were recruited from Epworth HealthCare's inpatient TBI Rehabilitation Unit. Trained nurses administered overnight PSG at the patient bedside using the Compumedics Somté portable PSG device (Compumedics, Ltd., Australia). Two weeks after PTA had resolved, PSG was repeated. On a separate evening, two saliva specimens were collected (at 24:00 and 06:00) for melatonin testing. Results of routine daily hospital measures (i.e., Agitated Behavior Scale and Westmead PTA Scale) were also collected. Twenty-nine patients were monitored with PSG (mean: 41.6 days post-TBI; standard deviation [SD]: 28.3). Patients' mean sleep duration was reduced (5.6 h, SD: 1.2), and was fragmented with frequent awakenings (mean: 27.7, SD: 15.0). Deep, slow-wave restorative sleep was reduced, or completely absent (37.9% of patients). The use of PSG did not appear to exacerbate patient agitation or cognitive disturbance. Mean melatonin levels at both time-points were commonly outside of normal reference ranges. After PTA resolved, patients (n = 11) displayed significantly longer mean sleep time (5.3 h [PTA]; 6.5 h [out of PTA], difference between means: 1.2, p = 0.005). However, disturbances to other sleep-wake parameters (e.g., increased awakenings, wake time, and sleep latency) persisted after PTA resolved. This is the first study to evaluate sleep disturbance in a cohort of patients as they progressed through the early TBI recovery phases. There is a clear need for tailored assessment of sleep disturbance during PTA, which currently does not form part of routine hospital assessment, to suggest new treatment paradigms, enhance patient recovery, and reduce its long-term impacts.

High pain reported at 3 months post-total knee arthroplasty often persists for the next 3 years and is associated with reduced function and quality of life.

BACKGROUND AND AIMS: Five to ten percent of people having a knee arthroplasty for osteoarthritis continue to experience high pain levels more than 3 months after surgery. The primary aim of this study was to determine the relative risk (RR) of having high pain at 12 and 36 months based on the presence of high pain at 3 and 12 months, respectively. METHODS: A retrospective analysis of data from a prospective study of participants who had a total knee arthroplasty for osteoarthritis. A score of ≤14 on the Oxford Knee Pain Subscale was defined as 'High Pain', and RRs were calculated comparing those with high or low pain. RESULTS: There were 718 participants and 13.8% reported high pain at any time point, 2.5% reported high pain at all time points and 10.3% and 4.7% and 6.6% reported high pain at 3-, 12- and 36-months, respectively, post-surgery. For participants with high pain at 3 months, 33.8% had high pain at 12 months with a RR of 24.2 (95% CI 11.7-49.8, p < 0.001) and 35.1% had high pain at 36 months with a RR of 10.8 (95% CI 6.4-18.2, p < 0.001). For participants with high pain at 12 months, 67.6% had high pain at 36 months, with a RR of 19.3 (95% CI 12.2-30.4, p < 0.01). CONCLUSIONS: Although high pain rates are low overall following knee arthroplasty, once high pain is established there is an elevated RR of it persisting at 12- and 36 months post-surgery. TRIAL REGISTRATION: The data were collected in the Evidence-based Processes and Outcomes of Care (EPOC) study, ClinicalTrials.gov Identifier: NCT01899443.

South of the UES: Improving the ability of speech-language pathologists to detect oesophageal abnormalities during videofluoroscopy swallowing studies.

PURPOSE: With two-thirds of adults presenting for a videofluoroscopy swallow study (VFSS) with oesophageal abnormalities, it seems prudent to include visualisation of the oesophagus, in the context of the entire swallow process, to provide further information to the diagnostic team. This study aims to evaluate the ability of speech-language pathologists (SLPs) to interpret oesophageal sweep on VFSS and the relative improvement in that ability with additional training. METHOD: One hundred SLPs attended training in oesophageal visualisation during VFSS, based on a previous study. Ten oesophageal sweep videos (five normal, five abnormal) with one 20 ml thin fluid barium bolus (19% w/v) were presented at baseline and following training. Raters were blinded to patient information other than age. Binary ratings were collected for oesophageal transit time (OTT), presence of stasis, redirection, and referral to other specialists. RESULT: Inter-rater reliability as measured by Fleiss' kappa improved for all parameters, reaching statistical significance for OTT (pre-test kappa = 0.34, post-test kappa = 0.73; p < 0.01) and redirection (pre-test kappa = 0.38, post-test kappa = 0.49; p < 0.05). Overall agreement improved significantly (p < 0.001) for all parameters except stasis, where improvement was only slight. Interaction between pre-post and type of video (normal/abnormal) was statistically significant (p < 0.001) for redirection, with a large pre-post increase in positive accuracy compared with a slight pre-post decrease in negative accuracy. CONCLUSION: Findings indicate that SLPs require training to accurately interpret an oesophageal sweep on VFSS. This supports the inclusion of education and training on both normal and abnormal oesophageal sweep patterns, and the use of standardised protocols for clinicians using oesophageal visualisation as part of the VFSS protocol.

The CONFIRM trial protocol: the utility of prostate-specific membrane antigen positron emission tomography/computed tomography in active surveillance for prostate cancer.

OBJECTIVES: Primary objectives: To determine the additive value of prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) in the risk stratification of men with newly diagnosed prostate cancer (PCa) who would have otherwise been deemed suitable for active surveillance (AS). Specifically, we aim to determine if PSMA PET/CT can detect a cohort of men on AS that are in fact high risk and likely to experience unfavourable outcomes should they remain on their current treatment pathway. SECONDARY OBJECTIVES: to determine the additive value of PSMA PET/CT to repeat multiparametric magnetic resonance imaging (mpMRI) of the prostate and explore whether a confirmatory biopsy may be avoided in men with a negative PSMA PET/CT and a negative repeat mpMRI of the prostate (Prostate Imaging-Reporting and Data System score of <3). Furthermore, to develop a nomogram combining clinical, imaging and biomarker data to predict the likelihood of failure on AS in men with high-risk features. Also, a blood sample will be taken to perform a Prostate Health Index test at the time of confirmatory biopsy. Furthermore, a portion of this blood will be stored at a biobank for up to 5 years if a follow-up study on molecular biomarkers and genetic assays in this cohort of men is indicated, based on the results from the CONFIRM trial. PATIENTS AND METHODS: The CONFIRM trial is a prospective, multicentre, pre-test/post-test, cohort study across Victoria, Australia, involving men with newly diagnosed low-risk PCa with high-risk features, considered suitable for AS and undergoing confirmatory biopsy. The trial's goal is to provide high-quality evidence to establish whether PSMA PET/CT has a role in risk-stratifying men deemed suitable for AS despite having high-risk feature(s). RESULTS: The CONFIRM trial will measure the proportion of men deemed unsuitable for ongoing AS based on pathological upgrading and multidisciplinary team recommendation due to PSMA PET/CT scan and PSMA-targeted confirmatory biopsy. Additionally, the positive and negative predictive values, sensitivity, and specificity of PSMA PET/CT will be calculated in isolation and combined with repeat mpMRI of the prostate. CONCLUSIONS: This trial will provide robust prospective data to determine if PSMA-PET/CT and standard of care (prostate biopsy ± repeat mpMRI) can improve diagnostic certainty in men undergoing confirmatory biopsy for low-grade PCa with high-risk features.

Comparison of 18F-based PSMA radiotracers with [68Ga]Ga-PSMA-11 in PET/CT imaging of prostate cancer-a systematic review and meta-analysis.

BACKGROUND: Prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/computed tomography (CT) has become an increasingly established imaging modality in the staging of prostate cancer (PCa). Numerous PSMA-based tracers are currently available, however, there is a lack of consensus on the optimal radiotracer(s) for PSMA PET/CT. This study aims to investigate whether Fluorine-18 (18F)-labelled PSMA PET/CT is significantly different from Gallium-68 (68Ga) in primary diagnosis and/or secondary staging of prostate cancer following biochemical recurrence. METHODS: A critical review of MEDLINE, EMBASE, PubMed and Web of Science databases was performed in May 2023 according to the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. Studies that directly compared 18F-based PSMA radiotracers and [68Ga]Ga-PSMA-11 in terms of the normal organ SUV or the lesion SUV or the detection rate were assessed. Quality was assessed using the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2). RESULTS: Twenty-four studies were analysed. [18F]DCFPyL and [18F]PSMA-1007 were the two most commonly studied 18F based PSMA tracers. [18F]JK-PSMA-7, [18F]rhPSMA-7, [18F]AlF-PSMA-11 were the new tracers evaluated in a limited number of studies. Overall, [18F]DCFPyL was observed to have a similar lesion detection rate to [68Ga]Ga-PSMA-11 with no increase in false positive rates. [18F]PSMA-1007 was found to have a greater local lesion detection rate because of its predominant hepatobiliary excretory route. However, [68Ga]Ga-PSMA-11 was observed to have a similar local lesion detection rate in studies that administer patients with furosemide prior to the scan. In addition, [18F]PSMA-1007 was found to have a significant number of benign bone uptakes. CONCLUSIONS: [18F]DCFPyL was observed to be similar to [68Ga]Ga-PSMA-11. [18F]PSMA-1007 was observed to be less preferrable to [68Ga]Ga-PSMA-11 due to its high benign bone uptakes. Overall, there was not enough evidence in differentiating the radiotracers based on their clinical impacts.

Outcomes of conservative treatment of acromial and scapular spine stress fracture post reverse shoulder arthroplasty: a systematic review with meta-analysis.

INTRODUCTION: Acromial and scapular spine stress fractures are common complications post reverse shoulder arthroplasty. A systematic review with meta-analysis was conducted to evaluate the clinical outcomes of conservatively treated acromial and scapular spine stress fractures post reverse shoulder arthroplasty in comparison to nonfracture control. METHODS: Embase, MEDLINE, and Web of Science were searched on September 9, 2022, using various terms related to fracture, acromion, scapula, and reverse shoulder arthroplasty. Meta-analysis using a random effects model was performed on common outcome scores. Risk of bias was assessed using the Joanna Briggs Institute tools for case-controlled studies. Sensitivity analysis was performed for imputed standard deviations and studies with <20 participants. RESULTS: Thirteen studies with a total of 339 fracture and 3142 control patients were included in the systematic review. Meta-analysis was performed on 12 studies assessing active forward flexion, abduction, external rotation, Constant-Murley score, American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form, pain score, Simple Shoulder Test, and Single Assessment Numeric Evaluation. Fracture patients experienced significantly poorer functional outcome compared with control patients when the fractures were managed conservatively. Levy III fractures tend to experience worse outcomes. Pain score did not demonstrate a statistically significant difference between the fracture and nonfracture cohort. DISCUSSION: Currently, literature regarding surgical management is lacking, partially because of a dearth of high-quality literature but also hindered by a lack of standardized techniques. This review was limited by inclusion of studies of low evidence, small sample sizes, and inconsistency in outcome measurement and follow-up period. Overall, patients with acromial and scapular spine stress fractures treated conservatively are expected to have reduced shoulder function compared to nonfracture patients, with the spine of scapula fracture patients suffering the poorest outcomes. Future studies should aim to use the same sets of outcomes parameters to assess the patients at fixed time intervals and report outcomes stratified by Levy classification. This will enable interinstitutional collaboration and pooling of results.

The adequacy of user seal checking for N95 respirators compared to formal fit testing: A multicentred observational study.

OBJECTIVE: The objective of this study was to evaluate the adequacy of the user seal check (USC) in predicting N95 respirator fit. DESIGN: This was a prospective, observational study conducted from May to September 2020. SETTING: The study setting included three private intensive care units (ICUs) in Victoria, Australia. PARTICIPANTS: ICU staff members in three private ICUs in Melbourne and regional Victoria participated in this study. MAIN OUTCOME MEASURES: The main outcome measure is the proportion of participants who passed a USC and subsequently failed fit testing of an N95 respirator. INTERVENTION: Three different respirators were available: two N95 respirator brands and CleanSpace HALO® powered air-purifying respirator. Participants were sequentially tested on N95 respirators followed by powered air-purifying respirators until either successful fit testing or failure of all three respirators. The first N95 tested was based on the availability on the day of testing. The primary outcome was failure rate of fit testing on the first N95 respirator type passing a USC. RESULTS: Of 189 participants, 22 failed USC on both respirators, leaving 167 available for the primary outcome. Fifty-one of 167 (30.5%, 95% confidence interval = 23.7-38.1) failed fit testing on the first respirator type used that had passed a USC. CONCLUSION: USC alone was inadequate in assessing N95 respirator fit and failed to detect inadequate fit in 30% of participants. Mandatory fit testing is essential to ensure adequate respiratory protection against COVID-19 and other airborne pathogens. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry: ACTRN12620001193965.

Reduction in Offset Is Associated With Worse Functional Outcomes Following Total Hip Arthroplasty.

BACKGROUND: Conflicting reports exist about the effect of offset variation on functional outcomes following total hip arthroplasty. Reproducing native hip offset is thought to optimize function by restoring biomechanics and appropriately tensioning the hip abductor muscles. The aim of this study is to assess the effect of failing to restore global hip offset in comparison to the native contralateral hip. METHODS: A retrospective analysis of a prospective patient cohort was performed on patients undergoing an elective primary total hip arthroplasty. A total of 414 patients who had a minimum of 12 months of follow-up were included. Postoperative plain radiographs were analyzed for offset and compared to the contralateral native hip. Western Ontario and McMaster Universities Arthritis Index (WOMAC) and Veterans RAND 12 (VR-12) scores were assessed preoperatively and at 12 months postoperatively. RESULTS: Regression analyses indicated that a reduction in offset of >20 mm resulted in worse WOMAC pain (P = .005) and motion (P = .015) scores compared to those with maintained offset. WOMAC function (P = .063), global (P = .025), and VR-12 scores were not affected (physical P = .656; mental P = .815). Reduction in offset up to 20 mm and increased offset were not significantly associated with patient-reported outcome measures (P-values ranged from .102 to .995). CONCLUSION: This study demonstrated an association between reduction in offset by >20 mm and worse WOMAC pain and motion scores following total hip arthroplasty. Surgeons should avoid decreases in offset >20 mm in order to optimize functional outcomes.

Laparoscopic and robot-assisted suture versus mesh hysteropexy: a retrospective comparison.

INTRODUCTION AND HYPOTHESIS: Our study was aimed at comparing the outcomes of laparoscopic and robot-assisted laparoscopic suture-based hysteropexy (SutureH) versus sacral hysteropexy using mesh (MeshH) for bothersome uterine prolapse. Our hypothesis is that MeshH is more successful and provides better uterine support than SutureH. METHODS: A retrospective cohort study of 228 consecutive women who underwent re-suspension of the uterus using uterosacral ligaments (SutureH n=97) or a "U-shaped" mesh from the sacral promontory (MeshH, n=132). Surgery was performed by laparoscopy or robot-assisted laparoscopy. Subjects were assessed at baseline, 1 year, and beyond 1 year. The null hypothesis, that SutureH and MeshH have similar success, was based on a composite outcome ("composite success"), and that they provide the same level of uterine support, was based on POP-Q point C at 1 year. "Composite success" was defined as: POP-Q point C above the hymen; absence of a vaginal bulge; no repeat uterine prolapse surgery or pessary placement. Other outcomes included improvement in symptomology using Patient Global Impression of Improvement, POP-Q point C change and complications. RESULTS: Follow-up data were available for 191 out of 228 women. "Composite success" was not significantly different between MeshH and SutureH groups (81.7% vs 84.5%, p=0.616). MeshH provided better elevation of the uterus than SutureH (point C change: -7.38cm vs -6.99cm; p<0.001). Similar symptom improvement and low complications occurred in both groups. CONCLUSIONS: Laparoscopic and robot-assisted laparoscopic suture hysteropexy and mesh sacral hysteropexy provide women with minimally invasive, durable surgical options for uterine preservation. "Composite success" was similar in the two groups, but MeshH provided better uterine support than SutureH. However, SutureH gives women an effective mesh-free option.

Patient-specific spinal rods in adult spinal deformity surgery reduce proximal junctional failure: a review of patient outcomes and surgical technique in a prospective observational cohort.

Background: Spinal rods used for adult spinal deformity (ASD) correction are usually manufactured straight and bent manually during surgery. Pre-bent patient-specific spinal rods (PSSR) developed with software provide the surgeon with an intraoperative deformity correction consistent with the surgical plan. Our aim was to report clinical and radiological outcomes using PSSR. We investigated rates of junctional complications both proximally [kyphosis (PJK) and failure (PJF)] and distally [failure (DJF)]. Methods: Prospective case series of 20 consecutive patients who underwent ≥4 level ASD surgery with PSSR at a single institution between January 2019 and December 2022. Preoperative, 6-week, 6-month, 12-month, 24-month, and final follow-ups assessed patient satisfaction (Ottawa decision regret questionnaire) and patient reported outcome measures (PROMs) [visual analogue scale (VAS; Back/Leg), Oswestry disability index (ODI), and 12-Item Short Form Survey (SF-12)]. Sagittal spinopelvic parameters [sagittal vertical axis (SVA), pelvic tilt (PT), and pelvic incidence and lumbar lordosis mismatch (PI-LL)] measured by serial EOS scans were performed preoperatively then compared to planned correction and postoperative measures. Interoperative cages (narrow/wide) were placed for interbody support. PJK risk score assessed likelihood of developing kyphosis. Serial computed tomography (CT) imaging assessed complication (fusion/subsidence). Results: The mean age of the patients (75% female) was 71.9±6.9 years, and the mean follow-up was 25.2±8.6 [7-40] months. Preoperative mean PROMs showed statistically significant overall improvement (P<0.001) postoperatively to final follow-up. Four patients without wide footprint cages at L4/5 or L5/S1, suffered DJF and reported regret undergoing surgery. Statistically significant difference (P<0.001) between preoperative and surgical plan in SVA and PI-LL but not in PT (P=0.058). No statistically significant difference in surgical plan versus the postoperative SVA, PI-LL, and PT (due to difficulty achieving the surgical plan, and also to maintaining the correction). One patient suffered PJF. There was a mean proximal kyphotic angle (PKA) of 17.8±13.0 degrees and PJK risk score of 3.7±1.0 with 40% who experienced PJK. No rod breakages were observed. Conclusions: In this series, PSSR improved PROMs and treated ASD. Sagittal parameters planned preoperatively correlated with postoperative correction. PJF was reduced, compared to the literature (35%), but PJK was observed over time. DJF occurred and was related to the absence of interbody cages at the lumbosacral junction and decisional regret.

The Demoralization Interview: Reliability and validity of a new brief diagnostic measure among medically ill patients.

BACKGROUND: Demoralization is a state of low morale and poor coping that is being increasingly recognized in stressful circumstances, such as illness. Meta-analyses show prevalence of 30% in the medically and 50% in the mentally ill. A brief structured diagnostic interview is needed to assess for and diagnose demoralization. METHODS: The Demoralization Interview (DI) was designed from items of the Demoralization Scale-II (DS-II) and common items used in other clinical interviews. The resultant 26 items were administered to 264 patients with serious progressive medical illnesses, together with the DS-II, measures of depression, anxiety, and quality of life. Rasch analysis was used to co-calibrate the DI against the DS-II. Sensitivity, specificity, and area under the receiver operating characteristics curve (AUROC) were assessed. Concurrent validation was conducted against measures of anxiety, depression, and quality of life. RESULTS: A 14-item Demoralization Interview (DI) with a diagnostic threshold of 6 symptoms generated sensitivity of 78.0%, specificity of 90.9%, and AUROC of 0.84 against the DS-II. Unidimensionality was indicated, with a Cronbach's alpha of 0.81. For respondents with 6 or more symptoms on the DI, 98% recognized a current stressor and 66% described significant distress or functional impairment. Demoralized respondents carried significantly lower quality of life, higher physical disability, and higher depressive and anxiety symptoms. CONCLUSIONS: The DI has good reliability and validity, with a threshold of 6 symptoms supporting a diagnosis of demoralization. It could be used as a stand-alone diagnosis, or as a specifier for adjustment disorder or depression.

Is inpatient rehabilitation a predictor of a lower incidence of persistent knee pain 3-months following total knee replacement? A retrospective, observational study.

BACKGROUND: Moderate to severe levels of persistent knee pain have been estimated to affect up to 25% of people 3-months or more after a total knee replacement. It is unknown whether the type of rehabilitation pathway is associated with persistent high pain after surgery. Using a prospectively followed Australian cohort who underwent total knee replacement for knee osteoarthritis, this study aimed to i) report the incidence of high-intensity knee pain (defined as a score ≤ 15 on the Oxford Knee Score pain subscale) across time and ii) identify whether referral to inpatient rehabilitation was one of the predictors of persistent pain at 3-months post-surgery. METHODS: A retrospective analysis of a large prospective study was conducted using the Oxford Knee Score pain subscale to determine if participants had high pain at 3-months, 12-months and 36-months post-surgery. Relative risks for high pain at 3-, 12- and 36-months between the type of rehabilitation pathway were determined using Poisson multivariable regression with robust standard errors. The same technique was also employed to determine potential predictors, including rehabilitation pathway, of high pain at 3 months. RESULTS: The incidence of high pain in all participants was 73% pre-surgery and 10, 5 and 6% at 3-, 12- and 36-months respectively following knee replacement. There was a significant interaction between time and rehabilitation pathway, suggesting that the effect of the rehabilitation pathway varied across time. The incidence of high pain at 3-months did not significantly differ between those who attended inpatient rehabilitation (11.6%) and those discharged directly home (9.5%). Multivariable Poisson regression analysis identified the pre-surgical presence of high pain, co-morbid low back pain or other lower limb problem, younger age and having a major complication within 3-months following surgery as significant predictors of persistent pain whilst discharge to inpatient rehabilitation was not. CONCLUSION: A small but clinically significant minority of people continued to have high pain levels at 3-, 12- and 36-months following a primary total knee replacement for osteoarthritis. Participation in an inpatient rehabilitation program does not appear to be an important predictor of ongoing knee pain. TRIAL REGISTRATION: The data were collected in the Evidence-based Processes and Outcomes of Care (EPOC) study, ClinicalTrials.gov Identifier: NCT01899443.

A comparison of agreement between actigraphy and polysomnography for assessing sleep during posttraumatic amnesia.

STUDY OBJECTIVES: Sleep disturbance often emerges in the early recovery phase following a moderate to severe traumatic brain injury, known as posttraumatic amnesia. Actigraphy is commonly employed to assess sleep, as it is assumed that patients in posttraumatic amnesia (who display confusion, restlessness, and agitation) would better tolerate this measure over gold-standard polysomnography (PSG). This study evaluated the agreement between PSG and actigraphy for determining (sleep/wake time, sleep efficiency, sleep latency, and awakenings) in patients experiencing posttraumatic amnesia. It also compared the epoch-by-epoch sensitivity, specificity, and accuracy between the Actigraph device's 4 wake threshold settings (low, medium, high, and automatic) to PSG. METHODS: The sample consisted of 24 inpatients recruited from a traumatic brain injury inpatient rehabilitation unit. Ambulatory PSG was recorded overnight at bedside and a Philips Actiwatch was secured to each patient's wrist for the same period. RESULTS: There were poor correlations between PSG and actigraphy for all parameters (Lin's concordance correlation coefficient = < 0.80). The low threshold displayed the highest correlation with PSG for wake and sleep time, albeit still low. Actigraphy displayed low specificity (ranging from 17.1% to 36.6%). There appears to be a greater disparity between actigraphy and PSG for patients with increased wake time. CONCLUSIONS: Actigraphy, while convenient, demonstrated poorer performance in determining sleep-wake parameters in patients with significantly disturbed sleep. Ambulatory PSG can provide a clearer understanding of the extent of sleep disturbances in these patients with reduced mobility during early rehabilitation. Study findings can help design future protocols of sleep assessment during posttraumatic amnesia and optimize treatment. CITATION: Fedele B, McKenzie D, Williams G, Giles R, Olver J. A comparison of agreement between actigraphy and polysomnography for assessing sleep during posttraumatic amnesia. J Clin Sleep Med. 2022;18(11):2605-2616.

Predicting strength outcomes for upper limb nerve transfer surgery in tetraplegia.

We report a retrospective study of 112 nerve transfers in 39 participants to investigate predictors of strength outcomes after nerve transfer surgery for upper limb reanimation in tetraplegia. We measured clinical and pre- and intraoperative neurophysiological assessment variables and compared them with strength outcomes 2 years after nerve transfer surgery. We found statistically significant improvement in Medical Research Council strength grades after nerve transfer surgery with lower cervical spine injuries (between one and two grades), lower donor nerve stimulation thresholds (half of a grade), greater motor evoked potential activity in recipient nerves (half of a grade) and greater muscle responses to intraoperative stimulation of donor (half of a grade) and recipient nerves (half of a grade).Level of evidence: III.

Dose-escalated radiotherapy to 82 Gy for prostate cancer following insertion of a peri-rectal hydrogel spacer: 3-year outcomes from a phase II trial.

BACKGROUND: Dose-escalation to above 80 Gy during external beam radiotherapy for localised prostate cancer leads to improved oncological outcomes but also substantially increased rectal toxicity. The aim of this study was to demonstrate the safety and efficacy of escalating the dose to 82 Gy following insertion of a peri-rectal hydrogel spacer (HS) prior to radiotherapy. METHODS: This was a single arm, open-label, prospective study of men with localised prostate cancer who were prescribed a course of intensity modulated radiotherapy escalated to 82 Gy in 2 Gy fractions following insertion of the SpaceOAR™ HS (Boston Scientific, Marlborough, MA). Patients were prescribed a standard course of 78 Gy in 2 Gy fractions where rectal dose constraints could not be met for the 82 Gy plan. The co-primary endpoints were the rate of grade 3 gastrointestinal (GI) and genitourinary (GU) adverse events (CTCAE, v4), and patient-reported quality of life (QoL) (EORTC QLQ-C30 and PR25 modules), up to 37.5 months post-treatment. RESULTS: Seventy patients received treatment on the study, with 64 (91.4%) receiving an 82 Gy treatment course. The median follow-up time post-treatment was 37.4 months. The rate of radiotherapy-related grade 3 GI and GU adverse events was 0% and 2.9%, respectively. There were 2 (2.9%) grade 3 adverse events related to insertion of the HS. Only small and transient declines in QoL were observed; there was no clinically or statistically significant decline in QoL beyond 13.5 months and up to 37.5 months post-treatment, compared to baseline. No late RTOG-defined grade ≥ 2 GI toxicity was observed, with no GI toxicity observed in any patient at 37.5 months post-treatment. Nine (12.9%) patients met criteria for biochemical failure within the follow-up period. CONCLUSIONS: Dose-escalation to 82 Gy, facilitated by use of a hydrogel spacer, is safe and feasible, with minimal toxicity up to 37.5 months post-treatment when compared to rates of rectal toxicity in previous dose-escalation trials up to 80 Gy. Trials with longer follow-up of oncological and functional outcomes are required to robustly demonstrate a sustained widening of the therapeutic window. Trial registration Australian New Zealand Clinical Trials Registry, ACTRN12621000056897 , 22/01/2021. Retrospectively registered.

Competency Assessment in Focused Cardiac Ultrasound-Can the Use of Sequential Testing Help Tailor Training Requirements?

Varying numbers of scans are required by different professional bodies before focused cardiac ultrasound (FCU) competence is assumed. It has been suggested that innovation in the assessment of FCU competence is needed and that competency assessment needs to be more individualized. We report our experience of how the use of sequential testing may help personalize the assessment of FCU competence. DESIGN: This was a planned exploratory reanalysis of previously prospectively collected data. FCU was performed sequentially by an intensive care trainee and expert on the same patient. Assessment of left ventricular (LV) function by the trainee and expert was compared. Sequential testing methods were used in the analysis of this data to see if they could be used to help in the assessment of competence. Each trainee had completed a 38-hour teaching program and a logbook of 30 scans prior to enrollment. SETTING: Tertiary Australian not for profit private academic hospital. MEASUREMENTS AND MAIN RESULTS: Two hundred seventy paired echocardiograms were completed by seven trainees. For trainees to achieve greater than 90% accuracy in correctly assessing LV function when compared with an expert, a variable number of scans were required. This ranged from 13 to 25 (95% CI, 13-25) scans. Over the study period, the ability to correctly identify LV function was maintained, and it appeared there was no degradation in skill. CONCLUSIONS: Using the Sequential Probability Ratio Test demonstrates a variable number of scans were required to show greater than 90% accuracy in the assessment of LV function. As such, the use of sequential testing could help individualize competency assessments in FCU. Additionally, our data suggests that over a 6-month period, echocardiographic skill is maintained without any formal teaching or feedback. Further work assessing the utility of this method based on larger samples is required.