2-week Outcome Research Articles

Effectiveness of an Advance Care Planning Intervention in Adults Receiving Dialysis and Their Families

Evidence of effectiveness of advance care planning (ACP) strategies for patients receiving dialysis and their families is needed. To test the effectiveness of an ACP intervention to prepare patients and their surrogates for end-of-life (EOL) decision-making and to improve surrogate bereavement outcomes. This cluster randomized clinical trial, An Effectiveness-Implementation Trial of SPIRIT (Sharing Patients' Illness Representations to Increase Trust) in ESRD, was conducted from December 2017 to March 2023 and included 42 dialysis clinics in 5 US states (Georgia, New Mexico, North Carolina, Pennsylvania, and Virginia) randomized to provide intervention or usual care. Recruitment was from February 15, 2018, to January 31, 2022, and patient-surrogate dyads were followed up for 21 months (until January 17, 2023) or until patient death. Each clinic selected 1 or 2 health care workers (eg, nurse practitioner, registered nurse, or social worker) to conduct 45- to 60-minute ACP discussions with dyads in the clinic or remotely. After March 13, 2020 (commencement of the COVID-19 emergency declaration), all discussions were conducted remotely. An ACP summary was placed in patients' medical records. The primary, 2-week preparedness outcomes were dyad congruence on EOL goals of care, patient decisional conflict, surrogate decision-making confidence, and a composite of dyad congruence and surrogate decision-making confidence. Secondary bereavement outcomes were anxiety, depression, and posttraumatic distress 3 months after patient death. To adjust for COVID-19 pandemic effects on bereavement outcomes, a variable to indicate the timing of baseline and 3-month assessment relative to the COVID-19 emergency declaration was created. Of the 426 dyads enrolled, 231 were in the intervention clinics, and 195 were in the control clinics. Among all dyads, the mean (SD) patient age was 61.9 (12.7) years, and the mean (SD) surrogate age was 53.7 (15.4) years. At 2 weeks, after adjusting for baseline values, dyad congruence (odds ratio [OR], 1.61; 95% CI, 1.12-2.31; P = .001), decisional conflict scores (β, -0.10; 95% CI, -0.13 to -0.07; P < .001), and the composite (OR, 1.57; 95% CI, 1.06-2.34; P = .03) were higher in the intervention group than in the control group. Surrogate decision-making confidence was similar between groups (β, 0.06; 95% CI, -0.01 to 0.13; P = .12). Among 77 bereaved surrogates, after adjusting for baseline values and assessment timing, intervention group anxiety was lower than control group anxiety (β, -1.55; 95% CI, -3.08 to -0.01; P = .05); however, depression (β, -0.18; 95% CI, -2.09 to 1.73; P = .84) and posttraumatic distress (β, -0.96; 95% CI, -7.39 to 5.46; P = .75) were similar. In this randomized clinical trial, the ACP intervention implemented by health care workers at dialysis centers improved preparation for EOL decision-making but showed mixed effectiveness on bereavement outcomes. The ACP intervention implemented in dialysis centers may be an effective strategy to the dyad preparation for end-of-life care as opposed to the current focus on advance directives. ClinicalTrials.gov Identifier: NCT03138564.

Acute Extra-Arachnoid Subdural Hematomas in Patients 50 Years and Older: When Subdurals Act Like Epidurals

Some patients with subdural hematoma (SDH) with acute extra-arachnoid lesions and without concomitant subarachnoid blood or contusions may present in similarly grave neurological condition compared with the general population of patients with SDH. However, these patients often make an impressive neurological recovery. This study compared neurological outcomes in patients with extra-arachnoid SDH with all other SDH patients. We compared a prospective series of extra-arachnoid SDH patients without subarachnoid hemorrhage or other concomitant intracranial injury with a Transforming Research and Clinical Knowledge in TBI control group with SDH only. We performed inverse probability weighting for key characteristics and ordinal regression with and without controlling for midline shift comparing neurological outcomes (Extended Glasgow Outcome Scale score) at 2 weeks. We used the Corticosteroid Randomization After Significant Head Injury prognostic model to predict mortality based on age, Glasgow Coma Scale score, pupil reactivity, and major extracranial injury. Mean midline shift was significantly different between extra-arachnoid SDH and control groups (7.2 mm vs. 2.7 mm, P < 0.001). After weighting for group allocation and controlling for midline shift, extra-arachnoid SDH patients had 5.68 greater odds (P < 0.001) of a better 2-week Extended Glasgow Outcome Scale score than control patients. Mortality in the extra-arachnoid SDH group was less than predicted by the Corticosteroid Randomization After Significant Head Injury prognostic model (10% vs. 21% predicted). Patients with extra-arachnoid SDH have significantly better 2-week neurological outcomes and lower mortality than predicted by the Corticosteroid Randomization After Significant Head Injury model. Neurosurgeons should consider surgery for this patient subset even in cases of poor neurological examination, older age, and large hematoma with high degree of midline shift.

Risk and accuracy of outpatient-identified hypoxaemia for death among suspected child pneumonia cases in rural Bangladesh: a multifacility prospective cohort study

Hypoxaemic pneumonia mortality risk in low-income and middle-income countries is high in children who have been hospitalised, but unknown among outpatient children. We sought to establish the outpatient burden, mortality risk, and prognostic accuracy of death from hypoxaemia in children with suspected pneumonia in Bangladesh. We conducted a prospective community-based cohort study encompassing three upazila (subdistrict) health complex catchment areas in Sylhet, Bangladesh. Children aged 3-35 months participating in a community surveillance programme and presenting to one of three upazila health complex Integrated Management of Childhood Illness (IMCI) outpatient clinics with an acute illness and signs of difficult breathing (defined as suspected pneumonia) were enrolled in the study; because lower respiratory tract infection mortality mainly occurs in children younger than 1 year, the primary study population comprised children aged 3-11 months. Study physicians recorded WHO IMCI pneumonia guideline clinical signs and peripheral arterial oxyhaemoglobin saturations (SpO2) in room air. They treated children with pneumonia with antibiotics (oral amoxicillin [40 mg/kg per dose twice per day for 5-7 days, as per local practice]), and recommended oxygen, parenteral antibiotics, and hospitalisation for those with an SpO2 of less than 90%, WHO IMCI danger signs, or severe malnutrition. Community health workers documented the children's vital status and the date of any vital status changes during routine household surveillance (one visit to each household every 2 months). The primary outcome was death at 2 weeks after enrolment in children aged 3-11 months (primary study population) and 12-35 months (secondary study population). Primary analyses included estimating the outpatient prevalence, mortality risk, and prognostic accuracy of hypoxaemia for death in children aged 3-11 months with suspected pneumonia. Risk ratios were produced by fitting a multivariable model that regressed predefined SpO2 ranges (<90%, 90-93%, and 94-100%) on the primary 2-week mortality outcome (binary outcome) using Poisson models with robust variance estimation. We established the prognostic accuracy of WHO IMCI guidelines for death with and without varying SpO2 thresholds. Participants were recruited between Sept 1, 2015, to Aug 31, 2017. During the study period, a total of 7440 children aged 3-35 months with the first suspected pneumonia episode were enrolled, of whom 3848 (54·3%) with an attempted pulse oximeter measurement and 2-week outcome were included in our primary study population of children aged 3-11-months. Among children aged 3-11 months, an SpO2 of less than 90% occurred in 102 (2·7%) of 3848 children, an SpO2 of 90-93% occurred in 306 (8·0%) children, a failed SpO2 measurement occurred in 67 (1·7%) children, and 24 (0·6%) children with suspected pneumonia died. Compared with an SpO2 of 94-100% (3373 [87·7%] of 3848), the adjusted risk ratio for death was 10·3 (95% CI 3·2-32·3; p<0·001) for an SpO2 of less than 90%, 4·3 (1·5-11·8; p=0·005) for an SpO2 of 90-93%, and 11·4 (3·1-41·4; p<0·001) for a failed measurement. When not considering pulse oximetry, of the children who died, WHO IMCI guidelines identified only 25·0% (95% CI 9·7-46·7; six of 24 children) as eligible for referral to hospital. For identifying deaths, in children with an SpO2 of less than 90% WHO IMCI guidelines had a 41·7% sensitivity (95% CI 22·1-63·4) and 89·7% specificity (88·7-90·7); for children with an SpO2 of less than 90% or measurement failure the guidelines had a 54·2% sensitivity (32·8-74·4) and 88·3% specificity (87·2-89·3); and for children with an SpO2 of less than 94% or measurement failure the guidelines had a 62·5% sensitivity (40·6-81·2) and 81·3% specificity (80·0-82·5). These findings support pulse oximeter use during the outpatient care of young children with suspected pneumonia in Bangladesh as well as the re-evaluation of the WHO IMCI currently recommended threshold of an SpO2 less than 90% for hospital referral. Fogarty International Center of the National Institutes of Health (K01TW009988), The Bill & Melinda Gates Foundation (OPP1084286 and OPP1117483), and GlaxoSmithKline (90063241).

Impact of analgesic regimen on patient outcome following subarachnoid hemorrhage: positive adjuvant effects of metamizole

Introduction Various analgesics are used to control intense headaches in patients following subarachnoid hemorrhage. In addition to pain control, it has been shown that some analgesics can affect various pathophysiological cascades. Therefore, we devised a study to assess whether the use of metamizole has a significant impact on the development of ischemic complications, hydrocephalus, and the overall outcome in patients following aneurysmal subarachnoid hemorrhage in the context of the other non-opioids and opioids effects. Methods In our retrospective, single-center cohort study, we enrolled 192 patients diagnosed with subarachnoid hemorrhage. We recorded their initial clinical status, comorbidities, and the daily dosage of analgesics over 14 days of hospitalization after the onset of subarachnoid hemorrhage. Using univariate and subsequent multivariate logistic regression analysis, we assessed the influence of various factors, including analgesics, on the development of delayed cerebral ischemia and hydrocephalus, as well as on 2-week and 6-month outcomes. Results Although the administration of non-opioids, in general, had no effect on the development of delayed cerebral ischemia or hydrocephalus, the use of metamizole as the main analgesic was associated with a significantly lower chance of poor outcome at both 2-weeks and 6-months, as well as the development of delayed cerebral ischemia. As opioids were indicated primarily for analgosedation in mechanically ventilated patients with poor clinical status, their usage was associated with a significantly higher chance of poor outcome, delayed cerebral ischemia, and hydrocephalus. Conclusion Our results suggest that the prescription of metamizole may be associated with better outcomes and a lower chance of delayed cerebral ischemia development in patients after subarachnoid hemorrhage. Considering the retrospective nature of our study and the limited worldwide availability of metamizole due to its prohibition in some countries, our results do not demonstrate a clear benefit but rather justify the need for subsequent prospective studies.

Outcomes in Patients With Mild Traumatic Brain Injury Without Acute Intracranial Traumatic Injury

Traumatic brain injury (TBI) affects millions of people in the US each year. Most patients with TBI seen in emergency departments (EDs) have a Glasgow Coma Scale (GCS) score of 15 and a head computed tomography (CT) scan showing no acute intracranial traumatic injury (negative head CT scan), yet the short-term and long-term functional outcomes of this subset of patients remain unclear. To describe the 2-week and 6-month recovery outcomes in a cohort of patients with mild TBI with a GCS score of 15 and a negative head CT scan. This cohort study analyzed participants who were enrolled from January 1, 2014, to December 31, 2018, in the Transforming Research and Clinical Knowledge in Traumatic Brain Injury (TRACK-TBI) study, a prospective, observational cohort study of patients with TBI that was conducted in EDs of 18 level I trauma centers in urban areas. Of the total 2697 participants in the TRACK-TBI study, 991 had a GCS score of 15 and negative head CT scan and were eligible for inclusion in this analysis. Data were analyzed from September 1, 2021, to May 30, 2022. The primary outcome was the Glasgow Outcome Scale-Extended (GOS-E) score, which was stratified according to functional recovery (GOS-E score, 8) vs incomplete recovery (GOS-E score, <8), at 2 weeks and 6 months after the injury. The secondary outcome was severity of mild TBI-related symptoms assessed by the Rivermead Post Concussion Symptoms Questionnaire (RPQ) total score. A total of 991 participants (mean [SD] age, 38.5 [15.8] years; 631 male individuals [64%]) were included. Of these participants, 751 (76%) were followed up at 2 weeks after the injury: 204 (27%) had a GOS-E score of 8 (functional recovery), and 547 (73%) had a GOS-E scores less than 8 (incomplete recovery). Of 659 participants (66%) followed up at 6 months after the injury, 287 (44%) had functional recovery and 372 (56%) had incomplete recovery. Most participants with incomplete recovery reported that they had not returned to baseline or preinjury life (88% [479 of 546]; 95% CI, 85%-90%). Mean RPQ score was 16 (95% CI, 14-18; P < .001) points lower at 2 weeks (7 vs 23) and 18 (95% CI, 16-20; P < .001) points lower at 6 months (4 vs 22) in participants with a GOS-E score of 8 compared with those with a GOS-E score less than 8. This study found that most participants with a GCS score of 15 and negative head CT scan reported incomplete recovery at 2 weeks and 6 months after their injury. The findings suggest that emergency department clinicians should recommend 2-week follow-up visits for these patients to identify those with incomplete recovery and to facilitate their rehabilitation.

Blood Flow Restriction Therapy for 2 Weeks Prior to Anterior Cruciate Ligament Reconstruction Did Not Impact Quadriceps Strength Compared to Standard Therapy

To evaluate the efficacy of a 2-week home-based blood flow restriction (BFR) prehabiliation program onquadriceps strength and patient-reported outcomes prior to anterior cruciate ligament (ACL) reconstruction. Patients presenting with an ACL tear were randomized into two groups, BFR and control, at their initial clinic visit. Quadriceps strength was measured using a handheld dynamometer in order to calculate peak force, average force, and time to peak force during seated leg extension at the initial clinic visit and repeated on the day of surgery. All patients were provided education on standardized exercises to be performed 5 days per week for 2 weeks between the initial clinic visit and date of surgery. The BFR group was instructed to perform these exercises with a pneumatic cuff set to 80% of limb occlusion pressure placed over the proximal thigh. Patient-Reported Outcome Measurement System Physical Function (PROMIS-PF), knee range of motion, and quadriceps circumference were gathered at the initial clinic visit and day of surgery, and patients were monitored for adverse effects. A total 45 patients met inclusion criteria and elected to participate. There were 23 patients randomized to the BFR group and 22 patients randomized into the control group. No significant differences were noted between the BFR and control groups in any demographic characteristics (48% vs 64% male [P= .271] and average age 26.5 ± 12.0 vs 27.0 ± 11.0 [P= .879] in BFR and control, respectively). During the initial clinic visit, there were no significant differences in quadriceps circumference, peak quadriceps force generation, time to peak force, average force, pain, and PROMIS scales (P > .05 for all). Following completion of a 2-week home prehabilitation protocol, all patients indeterminant of cohort demonstrated decreased strength loss in the operative leg compared to the nonoperative leg (P < .05 for both) However, there were no significant differences in any strength or outcome measures between the BFR and control groups (P > .05 for all). There were no complications experienced in either group, and both were compliant with the home-based prehabilitation program. A 2-week standardized prehabilitation protocol preceding ACL reconstruction resulted in a significant improvement in personal quadriceps peak force measurements, both with and without the use of BFR. No difference in quadriceps circumference, strength, or patient reported outcomes were found between the BFR and the control group. The home-based BFR prehabiliation protocol was found to be feasible, accessible, and well tolerated by patients. Level II, randomized controlled trial with small effect size.

Diagnostic and Prognostic Value of Cerebrospinal Fluid Lactate and Glucose in HIV-Associated Tuberculosis Meningitis.

ABSTRACTThe role of cerebrospinal fluid (CSF) lactate in tuberculosis meningitis (TBM) diagnosis and prognosis is unclear. The aim of this study was to evaluate the performance of CSF lactate alone and in combination with CSF glucose in predicting a diagnosis of TBM and 14-day survival. HIV-positive Ugandan adults were investigated for suspected meningitis. The baseline CSF tests included smear microscopy; Gram stain; cell count; protein; and point-of-care glucose, lactate, and cryptococcal antigen (CrAg) assays. Where CrAg was negative or there was suspicion of TBM, a CSF Xpert MTB/RIF Ultra (Xpert Ultra) test was performed. We recorded baseline demographic and clinical data and 2-week outcomes. Of 667 patients, 25% (n = 166) had TBM, and of these, 49 had definite, 47 probable, and 70 possible TBM. CSF lactate was higher in patients with definite TBM (8.0 mmol/L; interquartile ratio [IQR], 6.1 to 9.8 mmol/L) than in those with probable TBM (3.4 [IQR, 2.5 to 7.0] mmol/L), possible TBM (2.6 [IQR 2.1 to 3.8] mmol/L), and non-TBM disease (3.5 [IQR 2.5 to 5.0] mmol/L). A 2-fold increase in CSF lactate was associated with 8-fold increased odds of definite TBM (odds ratio, 8.3; 95% confidence interval [CI], 3.6 to 19.1; P < 0.01) and 2-fold increased odds of definite/probable TBM (odds ratio, 2.3; 95% CI, 1.4 to 3.7; P < 0.001). At a cut point of >5.5 mmol/L, CSF lactate could be used to diagnose definite TBM with a sensitivity of 87.7%, specificity of 80.7%, and a negative predictive value of 98.8%. CSF lactate was not predictive of 2-week mortality.IMPORTANCE Tuberculosis meningitis (TBM) is the most severe form of tuberculosis, and its fatality is largely due to delays in diagnosis. The role of CSF lactate has not been evaluated in patients with HIV presenting with signs and symptoms of meningitis. In this study, using a point-of-care handheld lactate machine in patients with HIV-associated meningitis, we showed that high baseline CSF lactate (>5.5 mmol) may be used to rapidly identify patients with TBM and shorten the time to initiate treatment with a similar performance to the Xpert Ultra assay for definite TBM. Elevated CSF lactate levels, however, were not associated with increased 2-week mortality in patients with HIV-associated TBM. Due to moderate specificity, other etiologies of meningitis should be investigated.

Randomized clinical trial of streaming dichoptic movies versus patching for treatment of amblyopia in children aged 3 to 7\xa0years

Contrast-rebalanced dichoptic movies have been shown to be an effective binocular treatment for amblyopia in the laboratory. Yet, at-home therapy is a more practical approach. In a randomized clinical trial, we compared dichoptic movies, streamed at-home on a handheld 3D-enabled game console, versus patching as amblyopia treatment. Sixty-five amblyopic children (3–7 years; 20/32–125) were randomly assigned to one of two parallel arms, binocular treatment (3 movies/week) or patching (14 h/week). The primary outcome, change in best corrected visual acuity (BCVA) at the 2-week visit was completed by 28 and 30, respectively. After the primary outcome, both groups of children had the option to complete up to 6 weeks of binocular treatment. At the 2-week primary outcome visit, BCVA had improved in the movie (0.07 ± 0.02 logMAR; p < .001) and patching (0.06 ± 0.01 logMAR; p < 0.001) groups. There was no significant difference between groups (CI95%: − 0.02 to 0.04; p = .48). Visual acuity improved in both groups with binocular treatment up to 6 weeks (0.15 and 0.18 logMAR improvement, respectively). This novel, at-home, binocular movie treatment improved amblyopic eye BCVA after 2 weeks (similar to patching), with additional improvement up to 6 weeks. Repeated binocular visual experience with contrast-rebalanced binocular movies provides an additional treatment option for amblyopia.Clincaltrials.gov identifier: NCT03825107 (31/01/2019).

Hydraulic- and Microprocessor-Controlled Ankle-Foot Prostheses for Limited Community Ambulators with Unilateral Transtibial Amputation: Pilot Study

ABSTRACT Introduction In the United States, access to microprocessor-controlled prosthetic ankles is limited to patients with lower-limb loss classified as unlimited community ambulators or greater. However, the potential benefits of these devices have not been evaluated among patients classified as household or limited community ambulators. This study examined the benefit of hydraulic- and microprocessor-controlled prosthetic ankles for patients classified as limited community ambulators. Materials and Methods Four different treatment configurations were evaluated using a randomized crossover study design. These four configurations included the participant's current flexible keel (FK) prosthetic foot, an energy-storage-and-return foot (ESAR), a hydraulic ankle (HA), and a microprocessor ankle (MPA). After a 2-week accommodation period, both patient-reported and performance-based outcome measures were recorded for each ankle foot system. A StepWatch activity monitor and two-dimensional video motion analysis were also used to evaluate each system. Results A single participant meeting the inclusion criteria was recruited. The patient-reported mobility and socket fit instruments were greatest with the HA system. When assessed on slopes and stairs, the MPA demonstrated benefits on hill ascent and stair descent. In considering the walking speed and perceived exertion jointly, the HA system allowed similar walking speed but lower exertion compared with fixed-ankle systems. The patient-reported low back pain and balance confidence instruments did not provide useful data for interpretation. Two-dimensional video motion analysis showed that the HA and MPA contributed to improved ankle and knee postures when ascending and descending a slope. The step activity data showed the greatest activity with the HA. Discussion The results from the outcome measures showed a varying level of benefit across all four of the treatment configurations. Both the HA and MPA had favorable scores in varying performance-based outcome measures, but the HA scored the most favorable in a majority of the patient-reported outcome measures. Conclusion The results show varying benefits of the microprocessor- and hydraulic-controlled prosthetic components over fixed-ankle ESAR and FK feet, based on both performance-based and patient-reported outcome measures. Further studies are needed to fully evaluate these benefits in larger sample sizes.

Prior sleep problems and adverse post-traumatic neuropsychiatric sequelae of motor vehicle collision in the AURORA study.

Many patients in Emergency Departments (EDs) after motor vehicle collisions (MVCs) develop post-traumatic stress disorder (PTSD) or major depressive episode (MDE). This report from the AURORA study focuses on associations of pre-MVC sleep problems with these outcomes 8 weeks after MVC mediated through peritraumatic distress and dissociation and 2-week outcomes. A total of 666 AURORA patients completed self-report assessments in the ED and at 2 and 8 weeks after MVC. Peritraumatic distress, peritraumatic dissociation, and pre-MVC sleep characteristics (insomnia, nightmares, daytime sleepiness, and sleep duration in the 30 days before the MVC, trait sleep stress reactivity) were assessed retrospectively in the ED. The survey assessed acute stress disorder (ASD) and MDE at 2 weeks and at 8 weeks assessed PTSD and MDE (past 30 days). Control variables included demographics, MVC characteristics, and retrospective reports about PTSD and MDE in the 30 days before the MVC. Prevalence estimates were 41.0% for 2-week ASD, 42.0% for 8-week PTSD, 30.5% for 2-week MDE, and 27.2% for 8-week MDE. Pre-MVC nightmares and sleep stress reactivity predicted 8-week PTSD (mediated through 2-week ASD) and MDE (mediated through the transition between 2-week and 8-week MDE). Pre-MVC insomnia predicted 8-week PTSD (mediated through 2-week ASD). Estimates of population attributable risk suggest that blocking effects of sleep disturbance might reduce prevalence of 8-week PTSD and MDE by as much as one-third. Targeting disturbed sleep in the immediate aftermath of MVC might be one effective way of reducing MVC-related PTSD and MDE.

Outcomes and cost-effectiveness of ultrasound-guided injection of the trochanteric bursa.

We hypothesized that ultrasound (US) guidance improves outcomes of corticosteroid injection of trochanteric bursitis. 40 patients with greater trochanteric pain syndrome defined by pain to palpation over the trochanteric bursa were randomized to injection with 5ml of 1% lidocaine and 80mg of methylprednisolone using (1) conventional anatomic landmark palpation guidance or (2) US guidance. Procedural pain (Visual Analogue Pain Scale), pain at outcome (2weeks and 6months), therapeutic duration, time-to-next intervention, and costs were determined. There were no complications in either group. Ultrasonography demonstrated that at least a 2-in (50.8mm) needle was required to consistently reach the trochanteric bursa. Pain scores were similar at 2weeks: US: 1.3 ± 1.9cm; landmark: 2.2 ± 2.5cm, 95% CI of difference: -0.7 < 0.9 < 2.5, p = 0.14. At 6months, US was superior: US: 3.9 ± 2.0cm; landmark: 5.5 ± 2.6cm, 95% CI of difference: 0.8 < 1.6 < 2.4, p = 0.036. However, therapeutic duration (US 4.7 ± 1.4 months; landmark 4.1 ± 2.9 months, 95% CI of difference -2.2<-0.6 < 1.0, p = 0.48), and time-to-next intervention (US 8.7 ± 2.9months; landmark 8.3 ± 3.8months, 95% CI of difference -2.8<-0.4 < 2.0, p = 0.62) were similar. Costs/patient/year was 43% greater with US (US $297 ± 99, landmark $207 ± 95; p = 0.017). US-guided and anatomic landmark injection of the trochanteric bursa have similar 2-week and 6-month outcomes; however, US guidance is considerably more expensive and less cost-effective. Anatomic landmark-guided injection remains the method of choice, but should be routinely performed using a sufficiently long needle [at least a 2 in (50.8mm)]. US guidance should be reserved for extreme obesity or injection failure.

Dichoptic movie viewing treats childhood amblyopia.

Contrast-balanced dichoptic experience with perceptual-learning tasks or simple games has been shown to improve visual acuity significantly in amblyopia. However, these tasks are intensive and repetitive, and up to 40% of unsupervised patients are noncompliant. We investigated the efficacy of a potentially more engaging movie method to provide contrast-balanced binocular experience via complementary dichoptic stimulation. Eight amblyopic children 4-10 years of age were enrolled in a prospective cohort study to watch 3 dichoptic movies per week for 2 weeks on a passive 3D display. Dichoptic versions of 18 popular animated feature films were created. A patterned image mask of irregularly shaped blobs was multiplied with the movie images seen by the amblyopic eye and an inverse mask was multiplied with the images seen by the fellow eye. Fellow-eye contrast was initially set at a reduced level that allowed binocular vision and was then incremented by 10% at each visit. Best-corrected visual acuity, random dot stereoacuity, and interocular suppression were measured at baseline and 2 weeks. Mean amblyopic eye visual acuity (with standard error of the mean) improved from a logarithm of minimum angle of resolution of 0.72 ± 0.08 at baseline to 0.52 ± 0.09 (P = 0.003); that is, 2.0 lines of improvement at the 2-week outcome visit. No significant change in interocular suppression or stereoacuity was found. Passive viewing of dichoptic feature films is feasible and could be a promising new treatment for childhood amblyopia. The maximum improvement that may be achieved by watching dichoptic movies remains to be determined. No known side effects are associated with this new treatment.

Short-term blood pressure variability in acute stroke: post hoc analysis of the controlling hypertension and hypotension immediately post stroke and continue or stop post-stroke antihypertensives collaborative study trials.

Short-term blood pressure variability (BPV) may predict outcome in acute stroke. We undertook a post hoc analysis of data from 2 randomized controlled trials to determine the effect of short-term BPV on 2-week outcome. Controlling Hypertension and Hypotension Immediately Post Stroke (CHHIPS) was a trial of BP-lowering, enrolling 179 acute stroke patients (onset<36 hours). Continue or Stop Post-Stroke Antihypertensives Collaborative Study (COSSACS) compared a strategy of continuation versus temporarily stopping prestroke antihypertensive therapy in 763 acute stroke patients (onset<48 hours). BPV at baseline (defined as SD, coefficient of variation, variation independent of the mean, and average real variability) was derived from standardized casual cuff BP measures (6 readings<30 minutes). Adjusted logistic regression models were used to assess the relation between BPV and death and disability (modified Rankin scale>3) at 2 weeks. Seven hundred six (92.5%) and 171 (95.5%) participants were included in the analysis for the COSSACS and CHHIPS data sets, respectively. Adjusted logistic regression analyses revealed no statistically significant associations between any of the included BPV parameters with 2-week death or disability in either study data set: COSSACS, odds ratio SD systolic BP 0.98 (0.78-1.23); CHHIPS, odds ratio SD systolic BP 0.97 (0.90-1.11). When derived from casual cuff BP measures, short-term BPV is not a useful predictor of early (2 weeks) outcome after acute stroke. Differing methodology may account for the discordance with previous studies indicating long-term (casual BPV) and short-term (beat-to-beat BPV) prognostic value. COSSACS was registered on the International Standard Randomised Controlled Trial Register; URL: http://www.isrctn.com. Unique identifier: ISRCTN89712435. CHHIPS was registered on the National Research Register; URL: http://public.ukcrn.org.uk. Unique identifier: N0484128008.

Pain sensitivity subgroups in individuals with spine pain: potential relevance to short-term clinical outcome.

Cluster analysis can be used to identify individuals similar in profile based on response to multiple pain sensitivity measures. There are limited investigations into how empirically derived pain sensitivity subgroups influence clinical outcomes for individuals with spine pain. The purposes of this study were: (1) to investigate empirically derived subgroups based on pressure and thermal pain sensitivity in individuals with spine pain and (2) to examine subgroup influence on 2-week clinical pain intensity and disability outcomes. A secondary analysis of data from 2 randomized trials was conducted. Baseline and 2-week outcome data from 157 participants with low back pain (n=110) and neck pain (n=47) were examined. Participants completed demographic, psychological, and clinical information and were assessed using pain sensitivity protocols, including pressure (suprathreshold pressure pain) and thermal pain sensitivity (thermal heat threshold and tolerance, suprathreshold heat pain, temporal summation). A hierarchical agglomerative cluster analysis was used to create subgroups based on pain sensitivity responses. Differences in data for baseline variables, clinical pain intensity, and disability were examined. Three pain sensitivity cluster groups were derived: low pain sensitivity, high thermal static sensitivity, and high pressure and thermal dynamic sensitivity. There were differences in the proportion of individuals meeting a 30% change in pain intensity, where fewer individuals within the high pressure and thermal dynamic sensitivity group (adjusted odds ratio=0.3; 95% confidence interval=0.1, 0.8) achieved successful outcomes. Only 2-week outcomes are reported. Distinct pain sensitivity cluster groups for individuals with spine pain were identified, with the high pressure and thermal dynamic sensitivity group showing worse clinical outcome for pain intensity. Future studies should aim to confirm these findings.

Endoscopic submucosal dissection of gastric lesions by using a master and slave transluminal endoscopic robot: an animal survival study

The feasibility of performing endoscopic submucosal dissection (ESD) using the Master and Slave Transluminal Endoscopic Robot (MASTER), a robotics-enhanced surgical system, has been shown in our previous study. This study aimed to further explore, in an animal survival study, the 2-week outcome of using MASTER to perform ESD. In this prospective study, ESD was performed on five female pigs (weighing 32.4 - 36.8 kg) under general anesthesia using the MASTER. The animals were observed for 2 weeks before being humanely killed for necropsy examination. The main outcome measures were completeness of resection, procedure-related complications, and survival at 2 weeks. The procedure was successfully completed in all five pigs. It took a mean of 21.8 minutes (range 6 - 39 minutes) to complete the ESD of each gastric lesion. All lesions were excised en bloc; the average dimension of the lesions was 77 mm (range 25 - 104 mm). One pig sustained a small intraoperative perforation which was identified and successfully clipped. After completion of the ESD procedures, all pigs survived well for 2 weeks. Necropsy was performed, with intraoperative gastroscopy identifying all the ESD sites as healed. Histopathologic examination showed all ESD sites had healed with partial epithelialization. Microbiological tests of the peritoneal fluid showed only microbes typically found in pigs. Performing ESD with MASTER was feasible and safe in this 2-week animal survival study.

Nerve Blocks at the Wrist for Painful Injections of the Palm

Injections into the palmar hand for trigger finger, palmar flexor tenosynovitis, and Dupuytren contracture can be very painful. This randomized, controlled study evaluated nerve block anesthesia at the wrist for prevention of procedural pain associated with painful injection of the palmar hand. Forty-seven corticosteroid injections for trigger fingers in 19 individuals were randomized to (1) anesthesia consisting of median and ulnar nerve block with 1% lidocaine anesthesia followed by standard injection or (2) standard injection alone using the 1-needle 2-syringe technique consisting of transthecal dilation of the synovial sheath with 0.5 mL 1% lidocaine with a mechanical syringe, the reciprocating procedure device, followed by injection with 20 mg triamcinolone acetonide. Baseline pain, needle insertion/sheath dilation pain, corticosteroid injection pain, resolution of trigger finger, and pain at outcome (2 weeks) were determined. Standard injection for trigger finger was associated with significant pain in 100% of subjects. Nerve blocks at the wrist provided effective anesthesia, resulting in a 56% reduction in injection pain compared with direct injection (P < 0.01). There was 100% resolution of trigger finger in both treatment groups. Pain at the 2-week outcome, reduction in pain from baseline, responders, and nonresponders were not statistically different (P > 0.3 for all). Eighty-eight percent of subjects preferred nerve block anesthesia to direct injection (P < 0.0001). Nerve block anesthesia at the wrist before palmar injection is preferred by patients and is highly effective in preventing pain associated with injection of the palmar hand for trigger finger and other painful hand procedures.

Effects of antihypertensive treatment after acute stroke in the Continue Or Stop post-Stroke Antihypertensives Collaborative Study (COSSACS): a prospective, randomised, open, blinded-endpoint trial

Up to 50% of patients with acute stroke are taking antihypertensive drugs on hospital admission. However, whether such treatment should be continued during the immediate post-stroke period is unclear. We therefore aimed to assess the efficacy and safety of continuing or stopping pre-existing antihypertensive drugs in patients who had recently had a stroke. The Continue or Stop Post-Stroke Antihypertensives Collaborative Study (COSSACS) was a UK multicentre, prospective, randomised, open, blinded-endpoint trial. Patients were recruited at 49 UK National Institute for Health Research Stroke Research Network centres from January 1, 2003, to March 31, 2009. Patients aged over 18 years who were taking antihypertensive drugs were enrolled within 48 h of stroke and the last dose of antihypertensive drug. Patients were randomly assigned (1:1) by secure internet central randomisation to either continue or stop pre-existing antihypertensive drugs for 2 weeks. Patients and clinicians who randomly assigned patients were unmasked to group allocation. Clinicians who assessed 2-week outcomes and 6-month outcomes were masked to group allocation. The primary endpoint was death or dependency at 2 weeks, with dependency defined as a modified Rankin scale score greater than 3 points. Analysis was by intention to treat. This trial is registered with the International Standard Randomised Controlled Trial Register, number ISRCTN89712435. 763 patients were assigned to continue (n=379) or stop (n=384) pre-existing antihypertensive drugs. 72 of 379 patients in the continue group and 82 of 384 patients in the stop group reached the primary endpoint (relative risk 0.86, 95% CI 0.65-1.14; p=0.3). The difference in systolic blood pressure at 2 weeks between the continue group and the stop group was 13 mm Hg (95% CI 10-17) and the difference in diastolic blood pressure was 8 mm Hg (6-10; difference between groups p<0.0001). No substantial differences were observed between groups in rates of serious adverse events, 6-month mortality, or major cardiovascular events. Continuation of antihypertensive drugs did not reduce 2-week death or dependency, cardiovascular event rate, or mortality at 6 months. Lower blood pressure levels in those who continued antihypertensive treatment after acute mild stroke were not associated with an increase in adverse events. These neutral results might be because COSSACS was underpowered owing to early termination of the trial, and support the continuation of ongoing research trials. The Health Foundation and The Stroke Association.

CONTINUE OR STOP POST-STROKE ANTIHYPERTENSIVES COLLABORATIVE STUDY (COSSACS): MAIN RESULTS: 6A.06

Background: Hypertension is an important modifiable risk factor for stroke prevention; up to 50% of patients taking antihypertensive therapy at the time of stroke onset. It is uncertain whether pre-existing treatment should be continued or stopped following acute stroke; both hypertension and hypotension being associated with adverse prognosis. Therefore, current guidelines call for further research to inform clinical practice. Methods: Previously independent (Modified Rankin Score (mRS) <4) patients were recruited to the UK multi-centre COSSACS trial within 48 hours of acute ischaemic or haemorrhagic stroke onset, and 48 hours of last dose of antihypertensive therapy. Patients were excluded if they had urgent indications for antihypertensive therapy, were dysphagic, had an impaired conscious level, or had a non-stroke diagnosis on subsequent neuroimaging. Patients were randomised by a secure internet-based service to continue or stop pre-existing antihypertensive treatment for 2 weeks. The primary outcome was 2-week death and dependency. Early secondary neurological, functional, adverse event and BP outcomes were undertaken by assessors blinded to treatment allocation at 2 weeks, and late secondary mortality and functional outcomes by telephone at 6 months. Results: 763 patients (426 male) of mean age 74.0 yrs (SD 10.8) and baseline BP 149(22)/ 81(13) mmHg were recruited. Premorbid mRS was 0 (65%), 1 (18%), 2 (13%) and 3 (4%). Most patients had a partial anterior circulation (41%) or lacunar (38%) clinical stroke syndrome. Neuroimaging confirmed cerebral haemorrhage was present in 5%. Median National Institutes of Health Stroke Scale score was 4. The majority of patients were on single (39%), dual (38%) or triple (17%) antihypertensive therapy at stroke onset. The main 2-week and 6-month trial outcomes will be presented. Conclusions: Acute post-stroke hypertension is associated with poor prognosis, but its management is uncertain. The COSSACS results will contribute to the evidence base to inform the acute management of post-stroke hypertension in patients on pre-existing antihypertensive therapy.

PREFABL: predictors of failure of antibiotic locks for the treatment of catheter-related bacteraemia

Antibiotic lock (ABL) solutions can effectively treat catheter-related bacteraemia (CRB) without the need for catheter exchange. This approach does not increase secondary infectious complications. We evaluated the risk factors that contribute to failure when CRB is treated with ABLs and systemic antibiotics in paediatric haemodialysis patients. A retrospective chart review of 72 children on haemodialysis between January 2004 and June 2006 was performed. We evaluated risk factors for ABL treatment using patients' characteristics, CRB/catheter characteristics and patients' biochemical profiles. The first CRB of each catheter was included in the statistical analysis. Our end points were outcome at 2 weeks of treatment and at 6 weeks following treatment. Compound symmetry covariance structure was employed for statistical analysis. We treated 149 CRB in 50 patients. The incidence was 3.4 CRB/1000 catheter days. Thirty CRB failed to be cleared with the use of ABL and systemic antibiotics at 2 weeks of treatment (30/149, 20 vs 80%, P < 0.001). Twenty-four of these catheters required exchange. Thirty-nine of the treated catheters got re-infected within the next 6 weeks (39/125, 31 vs 69%, P < 0.001). CRB aetiology was the only statistically significant independent variable for 2-week outcome (P = 0.033). Coagulase-negative Staphylococcus CRB had higher odds of being cleared at 2 weeks compared with other CRB aetiologies. For the 6-week outcome, the statistically significant independent variables in the final model included age (P = 0.048) and serum phosphorous level (P < 0.001). Younger age and higher serum phosphorous levels were independent risk factors for failure at 6 weeks with re-infection. Area under the receiver operating characteristic (ROC) curve for the model of the 2-week outcome was 0.736 with the percentage of correct predictions at 81.2%. Area under the ROC curve for the model of the 6-week outcome was 0.689 with the percentage of correct predictions at 75.5%. CRB can effectively be treated with ABLs and systemic antibiotics. CRB aetiology is the only independent variable of early treatment failure. Younger age and higher serum phosphorous levels are independent risk factors for re-infection at 6 weeks.

The prognostic value of C-reactive protein in long-term care patients requiring prolonged mechanical ventilation

C-reactive protein (CRP), a biomarker of inflammation, has predicted mortality in end-stage respiratory failure and in the critically ill patients. Our aim was to investigate if CRP can predict morbidity and mortality in patients requiring prolonged mechanical ventilation. A prospective study conducted in a ventilator weaning unit of a skilled nursing facility over 13 months included 98 patients older than 18 years of age requiring mechanical ventilation via tracheostomy. Serum CRP and albumin levels were tested on admission. Age, gender, body mass index (BMI), and diagnoses causing respiratory failure were recorded. The outcomes measured were as follows: hospitalization, weaned from mechanical ventilation, and death. Our population had a median age of 77 years and the median BMI, albumin, and mean CRP were 26 kg/m(2), 2.25 g/dL, and 5.75 mg/dL, respectively. The most common diseases leading to respiratory failure were pulmonary, neurologic, and cardiac. The patients with the empiric cutoff CRP of <2 mg/dL (n = 14) had 0% hospitalization rate at 2 weeks and 7% at 30 days, whereas the patients with CRP > or = 2 mg/dL (n = 84) had 26% hospitalization rate at 2 weeks and 38% at 30 days. Mortality for the patients with CRP > or = 2 mg/dL was 26% at 60 days, whereas the CRP < 2 mg/dL patients had no mortality at 60 days (P = 0.034). The patients who survived 60 days (n = 70) had significantly lower median CRP levels than the nonsurvivors (4.1 mg/dL vs 8.5 mg/dL, P = 0.009). The area under the receiver operating characteristic (ROC) curve for CRP levels predicting 2-week hospitalization was not large at 0.617 and the optimum CRP cutoff point was >2.7 mg/dL. The sensitivity and negative predictive value of the 2-week hospitalization outcome were equally high at 96%. The area under the ROC curve for 60-day survival was 0.691, and its optimum CRP cutoff point was >3.7 mg/dL with 85% sensitivity and 91% negative predictive value. CRP was not able to predict weaning success in this setting where the 60-day weaning rate was 9%. A CRP level of < or =2.7 mg/dL may be used to screen for patients who are not likely to develop acute illness requiring early 2-week rehospitalization, and a CRP level of < or =3.7 mg/dL may be used to predict 60-day survival in patients with respiratory failure requiring prolonged mechanical ventilation in the long-term care setting.