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.

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.

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.

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.

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.

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.

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.

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.

Does cognitive decline occur decades after moderate to severe traumatic brain injury? A prospective controlled study.

This prospective controlled study examined long-term trajectories of neuropsychological performance in individuals with traumatic brain injury (TBI) compared to healthy controls, and the impact of IQ, age at injury, time since injury, and injury severity on change over time. Fifty-three individuals with moderate to severe TBI (60.37% male; M = 59.77 yrs, SD = 14.03), and 26 controls (46.15% male; M = 63.96 yrs, SD = 14.42) were studied prospectively (M = 12.72 yrs between assessments). Participants completed measures of premorbid IQ (Weschler Test of Adult Reading), processing speed (Digit Symbol Coding Test), working memory (Digit Span Backwards), memory (Rey Auditory Verbal Learning Test) and executive function (Trail Making Test Part B; Hayling Errors), at a mean of 10.62 yrs (Initial) and 23.91 yrs (Follow-Up) post injury. Individuals with TBI did not show a significantly greater decline in neuropsychological performance over time compared with demographically similar controls. There was no association between change over time with IQ, time since injury or injury severity. Being older at injury had a greater adverse impact on executive function at follow-up. In this small sample, a single moderate to severe TBI was not associated with ongoing cognitive decline up to three decades post injury. Changes in cognitive function were similar between the groups and likely reflect healthy aging.

68Ga-PSMA-PET screening and transponder-guided salvage radiotherapy to the prostate bed alone for biochemical recurrence following prostatectomy: interim outcomes of a phase II trial.

PURPOSE: To evaluate outcomes for men with biochemically recurrent prostate cancer who were selected for transponder-guided salvage radiotherapy (SRT) to the prostate bed alone by 68Ga-labelled prostate-specific membrane antigen positron emission tomography (68Ga-PSMA-PET). METHODS: This is a single-arm, prospective study of men with a prostate-specific antigen (PSA) level rising to 0.1-2.5 ng/mL following radical prostatectomy. Patients were staged with 68Ga-PSMA-PET and those with a negative finding, or a positive finding localised to the prostate bed, continued to SRT only to the prostate bed alone with real-time target-tracking using electromagnetic transponders. The primary endpoint was freedom from biochemical relapse (FFBR, PSA > 0.2 ng/mL from the post-radiotherapy nadir). Secondary endpoints were time to biochemical relapse, toxicity and patient-reported quality of life (QoL). RESULTS: Ninety-two patients (median PSA of 0.18 ng/ml, IQR 0.12-0.36), were screened with 68Ga-PSMA-PET and metastatic disease was found in 20 (21.7%) patients. Sixty-nine of 72 non-metastatic patients elected to proceed with SRT. At the interim (3-year) analysis, 32 (46.4%) patients (95% CI 34.3-58.8%) were FFBR. The median time to biochemical relapse was 16.1 months. The rate of FFBR was 82.4% for ISUP grade-group 2 patients. Rates of grade 2 or higher gastrointestinal and genitourinary toxicity were 0% and 15.2%, respectively. General health and disease-specific QoL remained stable. CONCLUSION: Pre-SRT 68Ga-PSMA-PET scans detect metastatic disease in a proportion of patients at low PSA levels but fail to improve FFBR. Transponder-guided SRT to the prostate bed alone is associated with a favourable toxicity profile and preserved QoL. TRIAL REGISTRATION NUMBER: ACTRN12615001183572, 03/11/2015, retrospectively registered.

Risk Factors Associated With Poor Outcomes Following Temporomandibular Joint Discectomy and Fat Graft.

PURPOSE: Temporomandibular joint (TMJ) discectomy is performed for patients with degenerative joint disease with an unsalvageable disc, but with a salvageable condylar head and glenoid fossa. The purpose of this study was to estimate the incidence and risk factors associated with poor postoperative outcomes following TMJ discectomy and abdominal fat grafting. METHODS: A retrospective cohort study was conducted on patients who underwent TMJ discectomy. Included in this study were patients who had complete data sets with a minimum of 1-year follow-up. Potential risk factors included demographics, preoperative findings (mouth opening, pain levels, previous TMJ surgery), operative findings (disc degeneration, state of TMJ components), and postoperative outcomes (pain levels, mouth opening). Failed outcomes were those who had return of pain postoperatively, no improvement in mouth opening following TMJ discectomy, and/or those who progressed to TMJ total joint replacement (TJR). Statistical methods included Kaplan-Meier curves and Cox proportional hazards regression time to event analyses. RESULTS: This study included 129 patients who had undergone 132 TMJ discectomies. Most patients were female (89.9%), with a mean age of 43.2 years, standard deviation 14.2. The success rate for discectomy was 75.2% and the conversion rate of TMJ discectomy to TJR was 11.7%. A total of 32 patients (24.8%) experienced return of pain. The median time to return of pain or second surgery was 94.4 months (95% CI = 88.3 to 101.8). No risk factors were statistically significant, although mouth opening improvement of less than 10% was associated with higher risk of poor outcome (P = .77). CONCLUSION: The findings of this study suggest that lower improvement in mouth opening at 1 year following surgery is likely to result in failure of the TMJ discectomy procedure although the result was not statistically significant. This outcome may ultimately necessitate a TJR.

Reproducibility of an Intraoperative Pressure Sensor in Total Knee Replacement.

Appropriate soft tissue tension in total knee replacement (TKR) is an important factor for a successful outcome. The purpose of our study was to assess both the reproducibility of a modern intraoperative pressure sensor (IOP) and if a surgeon could unconsciously influence measurement. A consecutive series of 80 TKRs were assessed with an IOP between January 2018 and December 2020. In the first scenario, two blinded sequential measurements in 48 patients were taken; in a second scenario, an initial blinded measurement and a subsequent unblinded measurement in 32 patients were taken while looking at the sensor monitor screen. Reproducibility was assessed by intraclass correlation coefficients (ICCs). In the first scenario, the ICC ranged from 0.83 to 0.90, and in the second scenario it ranged from 0.80 to 0.90. All ICCs were 0.80 or higher, indicating reproducibility using a IOP and that a surgeon may not unconsciously influence the measurement. The use of a modern IOP to measure soft tissue tension in TKRs is a reproducible technique. A surgeon observing the measurements while performing IOP may not significantly influence the result. An IOP gives additional information that the surgeon can use to optimize outcomes in TKR.

Post Stroke Outcome: Global Insight into Persisting Sequelae Using the Post Stroke Checklist.

BACKGROUND: Following stroke, individuals commonly experience persisting loss of function. Whilst long-term care should involve continued support for ongoing stroke sequelae, this is often not routinely practiced globally. The Post Stroke Checklist was designed to standardise the process of detecting persisting treatable problems following stroke. AIMS: This cross-sectional study aimed to identify the long-term problems reported in Australian and Chinese participants at six months post stroke using the Post Stroke Checklist. It also aimed to provide global insight into poststroke sequelae by comparing the study results to previously published studies which administered the Post Stroke Checklist in other countries. METHODS: Participants were recruited from two hospitals in Australia and one hospital in China. The Post Stroke Checklist consists of 11 problem areas commonly experienced after stroke. This study follows a sequence of studies which have applied the checklist to monitor long-term outcomes after stroke in Germany, Italy, Singapore, Sweden and the United Kingdom. RESULTS: Comparisons between Australia (n = 112) and China (n = 97) demonstrated statistically significant differences on the Post Stroke Checklist items. Across all seven countries, collectively the most common persisting difficulties post-stroke related to: cognition, life after stroke, mood, mobility and activities of daily living. An analysis of means procedure compared individual countries for each checklist item against the overall group mean (all countries combined). CONCLUSIONS: Globally, individuals report persisting functional difficulties following stroke. There appear to be differences in the proportions affected across the various countries, and healthcare systems may benefit from geographically tailoring post-stroke care.

End-of-life care and intensive care unit clinician involvement in a private acute care hospital: A retrospective descriptive medical record audit.

INTRODUCTION: More Australians die in the hospital than in any other setting. This study aimed to (i) evaluate the quality of end-of-life (EOL) care in the hospital against an Australian National Standard, (ii) describe the characteristics of intensive care unit (ICU) clinician involvement in EOL care, and (iii) explore the demographic and clinical factors associated with quality of EOL care. METHOD: A retrospective descriptive medical record audit was conducted on 297 adult inpatients who died in 2017 in a private acute care hospital in Melbourne, Australia. Data collected related to 20 'Processes of Care', considered to contribute to the quality of EOL care. The decedent sample was separated into three cohorts as per ICU clinician involvement. RESULTS: The median age of the sample was 81 (25th-75th percentile = 72-88) years. The median tally for EOL care quality was 16 (25th-75th percentile = 13-17) of 20 care processes. ICU clinicians were involved in 65.7% (n = 195) of cases; however, contact with the ICU outreach team or an ICU admission during the final inpatient stay was negatively associated with quality of EOL care (coefficient = -1.51 and -2.07, respectively). Longer length of stay was positively associated with EOL care (coefficient = .05). Specialist palliative care was involved in 53% of cases, but this was less likely for those admitted to the ICU (p < .001). Evidence of social support, bereavement follow-up, and religious support were low across all cohorts. CONCLUSION: Statistically significant differences in the quality of EOL care and a negative association between ICU involvement and EOL care quality suggest opportunities for ICU outreach clinicians to facilitate discussion of care goals and the appropriateness of ICU admission. Advocating for inclusion of specialist palliative care and nonclinical support personnel in EOL care has merit. Future research is necessary to investigate the relationship between ICU intervention and EOL care quality.

Fractionated stereotactic body radiotherapy for up to five prostate cancer oligometastases: Interim outcomes of a prospective clinical trial.

Stereotactic body radiotherapy (SBRT) can delay escalation to systemic treatment in men with oligometastatic prostate cancer (PCa). However, large, prospective studies are still required to evaluate the efficacy of this approach in different patient groups. This is the interim analysis of a prospective, single institution study of men relapsing with up to five synchronous lesions following definitive local treatment for primary PCa. Our aim was to determine the proportion of patients not requiring treatment escalation following SBRT. In total, 199 patients were enrolled to receive fractionated SBRT (50 Gray in 10 fractions) to each visible lesion. Fourteen patients were castration resistant at enrolment. The proportion of patients not requiring treatment escalation 2 years following SBRT was 51.7% (95% CI: 44.1-59.3%). The median length of treatment escalation-free survival over the entire follow-up period was 27.1 months (95% CI; 21.8-29.4 months). Prior androgen deprivation therapy (ADT) predicted a significantly lower rate of freedom from treatment escalation at 2 years compared to no prior ADT (odds ratio = 0.21, 95% CI: 0.08-0.54, p = 0.001). There was no difference in the efficacy of SBRT when treating 4-5 vs. 1-3 initial lesions. A prostate-specific antigen (PSA) decline was induced in 75% of patients, with PSA readings falling to an undetectable level in six patients. No late grade three toxicities were observed. These interim results suggest that SBRT can be used to treat up to five synchronous PCa oligometastases to delay treatment escalation.

Relative risks and odds ratios: Simple rules on when and how to use them.

AIM: Relative risks and odds ratios are widely reported in the medical literature, but can be very difficult to understand. We sought to further clarify these important indices. METHODS: We illustrated both relative risks and odds ratios using bar charts, then looked at the types of study for which each statistic is suited. We demonstrated calculation of relative risks and odds ratios through analysis of tabled data from a recent published longitudinal study, using a 2 × 2 table and R, the open-source statistical programming language. Simple rules for when and how to use relative risks and odds ratios are presented. CONCLUSION: Understanding the difference between relative risks and odds ratios and when and how to use them may aid clinical interpretation, dissemination and translation of research findings.

Predictors of Anxiety and Depression Symptom Improvement in CBT Adapted for Traumatic Brain Injury: Pre/Post-Injury and Therapy Process Factors.

OBJECTIVES: The current study examined the association of demographic/preinjury, injury-related, and cognitive behavior therapy (CBT) process variables, with anxiety and depression symptom change in traumatic brain injury (TBI)-adapted CBT (CBT-ABI). METHODS: The audio recordings of 177 CBT-ABI sessions representing 31 therapist-client dyads were assessed from the independent observer perspective on measures of working alliance, homework engagement, and therapist competency in using homework. RESULTS: Linear regressions showed that older client age, longer post-TBI recovery period, better executive functioning, higher levels of client homework engagement, as well as higher levels of therapist competence in reviewing homework were associated with greater improvement in anxiety and/or depression symptoms. CONCLUSIONS: CBT-ABI is a promising treatment for post-TBI depression and anxiety. The current study highlights how therapists can enhance CBT-ABI effectiveness, specifically: comprehensive facilitation of client homework engagement with emphasis on homework review, and accommodation of executive deficits. The current study also suggests that the role of client age and the length of post-TBI recovery period require further investigation.

Telehealth Delivery of Memory Rehabilitation Following Stroke.

OBJECTIVE: Rehabilitation of memory after stroke remains an unmet need. Telehealth delivery may overcome barriers to accessing rehabilitation services. METHOD: We conducted a non-randomized intervention trial to investigate feasibility and effectiveness of individual telehealth (internet videoconferencing) and face-to-face delivery methods for a six-week compensatory memory rehabilitation program. Supplementary analyses investigated non-inferiority to an existing group-based intervention, and the role of booster sessions in maintaining functional gains. The primary outcome measure was functional attainment of participants' goals. Secondary measures included subjective reports of lapses in everyday memory and prospective memory, reported use of internal and external memory strategies, and objective measures of memory functioning. RESULTS: Forty-six stroke survivors were allocated to telehealth and face-to-face intervention delivery conditions. Feasibility of delivery methods was supported, and participants in both conditions demonstrated treatment-related improvements in goal attainment, and key subjective outcomes of everyday memory, and prospective memory. Gains on these measures were maintained at six-week follow-up. Short-term gains in use of internal strategies were also seen. Non-inferiority to group-based delivery was established only on the primary measure for the telehealth delivery condition. Booster sessions were associated with greater maintenance of gains on subjective measures of everyday memory and prospective memory. CONCLUSIONS: This exploratory study supports the feasibility and potential effectiveness of telehealth options for remote delivery of compensatory memory skills training after a stroke. These results are also encouraging of a role for booster sessions in prolonging functional gains over time.

Subacute sleep disturbance in moderate to severe traumatic brain injury: a systematic review.

Objective: This systematic review evaluated subacute sleep disturbance following moderate to severe traumatic brain injury (TBI) and the impact of secondary factors such as mood or pain.Methods: A comprehensive search strategy was applied to nine databases. Inclusion criteria included: adults ≥18 years, moderate and severe TBI and within 3 months of injury. Eligible studies were critically appraised using the McMaster Quantitative Critical Review Form. Study characteristics, outcomes, and methodological quality were synthesized. This systematic review was registered with PROSPERO (Registration number: CRD42018087799).Results: Ten studies were included. Research identified early-onset sleep disturbances; characterized as fragmented sleep periods and difficulty initiating sleep. Alterations to sleep architecture (e.g. rapid eye movement sleep) were reported. Sleep disturbance appears to associate with alterations of consciousness. Sleep disturbance tended to be particularly increased during the phase of post-traumatic amnesia (PTA) (78.7%).Conclusions: There is a limited amount of research available, which has inherent measurement and sample size limitations. The gold standard for measuring sleep (polysomnography) was rarely utilized, which may affect the detection of sleep disturbance and sleep architecture. Secondary factors potentially influencing sleep were generally not reported. Further evaluation on associations between sleep and PTA is needed.

Predictors of working alliance in cognitive behaviour therapy adapted for traumatic brain injury.

Cognitive Behaviour Therapy (CBT) has the strongest preliminary support for treatment of depression and anxiety following traumatic brain injury (TBI). TBI associated cognitive impairments may pose an obstacle to development of a strong working alliance, on which therapeutic gains depend. The current study examined the association of demographic (i.e., gender, age at study entry, years of education and premorbid IQ) and injury-related (i.e., years since injury, post-trauma amnesia duration, memory and executive functioning test performance) variables with alliance in CBT adapted for TBI (CBT-ABI). The audio-recordings of 177 CBT-ABI sessions from 31 participants were assessed with an observer version of the Working Alliance Inventory at nine time-points. Multi-level mixed model regressions showed that participants and therapists maintained a relatively strong alliance across all sessions. Pre-intervention symptom severity was considered as a confounder variable and was found to have no statistically significant influence on the models. None of the demographic variables were significantly associated with alliance scores. More years since injury was associated with a stronger alliance. These findings demonstrate that TBI associated cognitive impairments do not necessarily pose an obstacle to development and maintenance of a strong working alliance, which is more likely to develop with more time post-brain injury.