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Eighty consecutive complex spinal robotic cases utilizing intraoperative 3D CT imaging (E3D, Group 2) were compared to 80 age-matched controls using the Excelsius robot alone with C-arm Fluoroscopic registration (Robot Only, Group 1). The demographics between the two groups were similar-severity of deformity, ASA Score for general anesthesia, patient age, gender, number of spinal levels instrumented, number of patients with prior spinal surgery, and amount of neurologic compression. The intraoperative CT scanning added several objective factors improving patient safety. There were significantly fewer complications in the E3D group with only 3 of 80 (4%) patients requiring a return to the operating room compared to 11 of 80 (14%) patients in the Robot Only Group requiring repeat surgery for implant related problems (Chi squared analysis = 5.00, p = 0.025). There was a significant reduction the amount of fluoroscopy time in the E3D Group (36 s, range 4-102 s) compared to Robot only group (51 s, range 15-160 s) (p = 0.0001). There was also shorter mean operative time in the E3D group (257 ± 59.5 min) compared to the robot only group (306 ± 73.8 min) due to much faster registration time (45 s). A longer registration time was required in the Robot only group to register each vertebral level with AP and Lateral fluoroscopy shots. The estimated blood loss was also significantly lower in Group 2 (mean 345 ± 225 ml) vs Group 1 (474 ± 397 ml) (p = 0.012). The mean hospital length of stay was also significantly shorter for Group 2 (3.77 ± 1.86 days) compared to Group 1 (5.16 ± 3.40) (p = 0.022). There was no significant difference in the number of interbody implants nor corrective osteotomies in both groups-Robot only 52 cases vs. 42 cases in E3D group.Level of evidence: IV, Retrospective review.
Subject(s)
Imaging, Three-Dimensional , Operative Time , Robotic Surgical Procedures , Spinal Fusion , Tomography, X-Ray Computed , Humans , Robotic Surgical Procedures/methods , Female , Male , Spinal Fusion/methods , Spinal Fusion/instrumentation , Middle Aged , Adult , Imaging, Three-Dimensional/methods , Aged , Fluoroscopy/methods , Tomography, X-Ray Computed/methods , Surgery, Computer-Assisted/methods , Young Adult , Aged, 80 and over , Retrospective Studies , Postoperative Complications/etiologyABSTRACT
BACKGROUND AND AIMS: Improving the care of decompensated cirrhosis is a significant clinical challenge. The primary aim of this trial was to assess the efficacy of a chronic disease management (CDM) model to reduce liver-related emergency admissions (LREA). The secondary aims were to assess model effects on quality-of-care and patient-reported outcomes. APPROACH AND RESULTS: The study design was a 2-year, multicenter, randomized controlled study with 1:1 allocation of a CDM model versus usual care. The study setting involved both tertiary and community care. Participants were randomly allocated following a decompensated cirrhosis admission. The intervention was a multifaceted CDM model coordinated by a liver nurse. A total of 147 participants (intervention=75, control=71) were recruited with a median Model for End-Stage Liver Disease score of 19. For the primary outcome, there was no difference in the overall LREA rate for the intervention group versus the control group (incident rate ratio 0.89; 95% CI: 0.53-1.50, p=0.666) or in actuarial survival (HR=1.14; 95% CI: 0.66-1.96, p=0.646). However, there was a reduced risk of LREA due to encephalopathy in the intervention versus control group (HR=1.87; 95% CI: 1.18-2.96, p=0.007). Significant improvement in quality-of-care measures was seen for the performance of bone density (p<0.001), vitamin D testing (p<0.001), and HCC surveillance adherence (p=0.050). For assessable participants (44/74 intervention, 32/71 controls) significant improvements in patient-reported outcomes at 3 months were seen in self-management ability and quality of life as assessed by visual analog scale (p=0.044). CONCLUSIONS: This CDM intervention did not reduce overall LREA events and may not be effective in decompensated cirrhosis for this end point.
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BACKGROUND: Hepatitis C is a global epidemic and an estimated 230 000 Australians were living with chronic hepatitis C in 2016. Through effective public health policy and state commitment, Australia has utilised the advent of direct acting antiviral (DAA) therapy to transform the therapeutic landscape for hepatitis C virus (HCV). However, treatment rates are falling and novel public health approaches are required to maintain momentum for HCV elimination. Contemporary discourse in cascades of care have focused on expanding testing capabilities but less attention has been given to linking previously diagnosed patients back to care. Our simple and focused study rests on the premise that hospital admissions are an excellent opportunity to identify and refer previously diagnosed patients for HCV treatment. AIM: To assess whether inpatients with HCV are appropriately referred on for treatment. METHODS: We conducted a retrospective single centre cohort study that examined all patients with HCV presenting to The Queen Elizabeth Hospital (QEH) inpatient service between January 1 and December 31, 2017. QEH is a tertiary care hospital in South Australia. The main inclusion criteria were patients with active HCV infection who were eligible for DAA therapy. Our study cohort was identified using a comprehensive list of diagnosis based on international classification of diseases-10 AM codes for chronic viral hepatitis. Patients were excluded from the analysis if they had previously received DAA therapy or spontaneously cleared HCV. Patients presenting with decompensated liver cirrhosis or other systemic medical conditions conferring poor short-term prognosis were also excluded from the analysis. The primary outcome of our study was referral of patients for HCV treatment. Secondary outcomes included assessment of factors predicting treatment referral. RESULTS: There were 309 inpatients identified with hepatitis C as a principal or additional diagnosis between January 1 and December 31, 2017. Of these patients, 148 had active HCV infection without prior treatment or spontaneous clearance. Overall, 131 patients were deemed eligible for DAA treatment and included in the main analysis. Mean patient age was 47.75 ± 1.08 years, and 69% of the cohort were male and 13% identified as Aboriginal or Torres Strait Islander. Liver cirrhosis was a complication of hepatitis C in 7% of the study cohort. Only 10 patients were newly diagnosed with HCV infection during the study period with the remainder having been diagnosed prior to the study. CONCLUSION: Under 25% of hepatitis C patients presenting to an Australian tertiary hospital were appropriately referred for treatment. Advanced age, cirrhosis and admission under medical specialties were predictors of treatment referral.
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BACKGROUND: Riociguat is effective in delaying the time to clinical worsening (TCW) in patients with groups 1 and 4 pulmonary hypertension. RESEARCH QUESTION: Is riociguat more effective than placebo in prolonging TCW in sarcoidosis-associated pulmonary hypertension (SAPH)? STUDY DESIGN AND METHODS: This was a double-blind placebo-controlled trial. Patients with SAPH confirmed by right heart catheterization were randomized 1:1 to riociguat or placebo. Patients underwent 6-min walk distance (6MWD) and spirometry testing every 8 weeks. The primary end point was TCW, which was defined by the time to the first of the following: (1) all-cause mortality, (2) need for hospitalization because of worsening cardiopulmonary status attributable to progression of disease, (3) > 50 m decrease in the 6MWD test, or (4) worsening of World Health Organization functional class. RESULTS: A total of 16 patients were randomized to riociguat (n = 8) or placebo (n = 8). No difference was found in pulmonary artery mean, pulmonary vascular resistance, initial 6MWD, or FVC between the two groups. Five of eight patients who received placebo met TCW criteria, whereas none of the patients who received riociguat experienced a qualifying event. By log-rank analysis, patients who received riociguat were in the study for a significantly longer period (χ 2 = 6.259; P = .0124). The 6MWD decreased in the placebo group (median, -55.9 m; range, -176.8 to 60 m), but rose in the riociguat group (median, +42.7 m; range, -7.5 to +91.4 m; P = .0149), with a placebo-corrected difference of 94 m (P < .01). Four of eight patients who received riociguat, but only 1 of 8 patients who received placebo, showed a > 30-m improvement in 6MWD (P > .05). No significant adverse events associated with riociguat occurred. INTERPRETATION: Over the 1 year of the study, riociguat was effective in preventing clinical worsening and improving exercise capacity in patients with SAPH. TRIAL REGISTRY: ClinicalTrials.gov; No.: NCT02625558; URL: www.clinicaltrials.gov.
Subject(s)
Enzyme Activators/therapeutic use , Hypertension, Pulmonary/etiology , Hypertension, Pulmonary/prevention & control , Pyrazoles/therapeutic use , Pyrimidines/therapeutic use , Sarcoidosis/drug therapy , Aged , Disease Progression , Double-Blind Method , Female , Humans , Hypertension, Pulmonary/physiopathology , Male , Middle Aged , Quality of Life , Sarcoidosis/physiopathology , Spirometry , Walk TestABSTRACT
BACKGROUND: Comorbid disease is a risk factor for severe coronavirus disease 2019 (COVID-19) infection. However, initial rates of chronic obstructive pulmonary disease (COPD) in case series were low and severity of COVID-19 in COPD patients was variable. METHODS: We performed a retrospective study of patients admitted with COVID-19 and evaluated outcomes in those with and without COPD and/or emphysema. Patients were identified as having COPD if they had a diagnosis in the medical record and a history of airflow-obstruction on spirometry, or a history of tobacco use and prescribed long-acting bronchodilator(s). Computed tomography scans were evaluated by radiologists. Propensity matching was performed for age, body mass index (BMI), and serologic data correlated with severity of COVID-19 disease (D-dimer, C-reactive protein, ferritin, fibrinogen, absolute lymphocyte count, lymphocyte percentage, and lactate dehydrogenase). RESULTS: Of 577 patients admitted with COVID-19, 103 had a diagnosis of COPD and/or emphysema. The COPD/emphysema cohort was older (67 versus 58, p<0.0001) than the other cohort and had a lower BMI. Among unmatched cohorts those with COPD/emphysema had higher rates of intensive care unit (ICU) admission (35% versus 24.9%, p=0.036) and maximal respiratory support requirements, with more frequent invasive mechanical ventilation (21.4% versus 11.8%), but no significant difference in mortality. After propensity-matching there was no difference in ICU admission, maximal respiratory support requirements, or mortality. Univariate and multivariate regression analyses yielded similar results. DISCUSSION: Our propensity-matched retrospective cohort study suggests that patients hospitalized with COVID-19 who have COPD and/or emphysema may not have worse outcomes than those without these comorbid conditions.
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BACKGROUND: Young adults often tolerate the increased energy expenditure, coordination, and stance limb discomfort associated with walking aids for nonweightbearing ambulation. Adults aged ≥50 years may not have the same tolerance. Therefore, the objective of this study was to determine how walking aid selection affects stance limb plantar force, walking speed, perceived exertion, and device preference in adults aged ≥50 years. METHODS: A prospective randomized crossover study was performed using healthy adults, aged ≥50 years, with no use of walking aids within 5 years. Participants walked 200 m in 4 randomized conditions: single nonweightbearing ambulation using crutches, a walker, a wheeled knee walker, and unaided walking. An in-shoe sensor measured stance limb plantar force, a stopwatch timed each walk, perceived exertion was reported using the BORG CR-10 scale, and device preference was identified. RESULTS: Twenty-one participants (7 male; age: 56 ± 5 years; BMI: 26.6 ±1.9) showed stance limb plantar force was lowest when using a wheeled knee walker (P < .001). Walking speed was similar in unaided and wheeled knee walker conditions (1.41 and 1.31 m/s), but slower with crutches or a walker (42%-68%, P < .001). Perceived exertion was similar in unaided and wheeled knee walker conditions (1.6 and 2.8), but higher with crutches or a walker (5.7 and 6.1, P < .001). Most (20/21) participants preferred the wheeled knee walker. CONCLUSIONS: Using a wheeled knee walker for nonweightbearing ambulation reduced stance limb plantar force, maintained unaided walking speed and perceived exertion, and was preferred to crutches or a walker. LEVEL OF EVIDENCE: Level II, comparative study.
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BACKGROUND: A unique model of care was adopted in Australia following introduction of universal subsidised direct-acting antiviral (DAA) access in 2016 in order to encourage rapid scale-up of treatment. Community-based medical practitioners and integrated hepatitis nurses initiated DAA treatment with remote hepatitis specialist approval of the planned treatment without physical review. AIMS: To evaluate outcomes of community-based treatment of hepatitis C virus (HCV) through this remote consultation process in the first 12 months of this model of care. METHODS: A retrospective chart review of patients undergoing community-based HCV treatment from general practitioners and integrated hepatitis nurse consultants through the remote consultation model in three state jurisdictions in Australia from 1 March 2016 to 28 February 2017. RESULTS: Sustained virological response at 12 weeks (SVR12) was confirmed in 383 (65.1%) of 588 subjects intended for treatment with a median follow-up time of 12 months (interquartile range 9-14 months). The SVR12 test was not performed in 159 (27.0%) of 588 and 307 (52.2%) of 588 did not have liver biochemistry rechecked following treatment. Subjects who completed follow up exhibited high SVR12 rates (383/392; 97.7%). Nurse-led treatment was associated with higher confirmation of SVR12 (73.7% vs 62.4%; P = 0.01) and liver biochemistry testing post treatment (57.5% vs 45.0%; P = 0.01). CONCLUSIONS: Community-based management of HCV through remote specialist consultation may be an effective model of care. Failure to check SVR12, recheck liver biochemistry and appropriate surveillance in patients with cirrhosis may emerge as significant issues requiring further support, education and refinement of the model to maximise effectiveness of future elimination efforts.
Subject(s)
General Practitioners , Hepatitis C, Chronic , Hepatitis C , Remote Consultation , Antiviral Agents/therapeutic use , Australia/epidemiology , Hepacivirus , Hepatitis C/diagnosis , Hepatitis C/drug therapy , Hepatitis C/epidemiology , Hepatitis C, Chronic/drug therapy , Humans , Retrospective Studies , Treatment OutcomeABSTRACT
We describe a case of successful use of veno-arterial (VA) extracorporeal membrane oxygenation (ECMO), as a bridge to cytoreductive therapy, in a patient with large mediastinal mass due to T cell lymphoblastic leukemia, complicated by acute cardiorespiratory compromise from mechanical compression and pulmonary embolism.
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BACKGROUND: Pulmonary hypertension (PH) causes increased morbidity and mortality in patients with interstitial lung diseases (ILD). Classification schemes, while well-characterised for the vasculopathy of idiopathic PH, have been applied, unchallenged, to ILD-related PH. We evaluated pulmonary arterial histopathology in explanted human lung tissue from patients who were transplanted for advanced fibrotic ILD. METHODS: Lung explants from 38 adult patients who underwent lung transplantation were included. Patients were divided into three groups: none, mild/moderate and severe PH by mean pulmonary artery pressure (mPAP) measured at pre lung transplantation right heart catheterisation (RHC). Grading of pulmonary vasculopathy according to Heath and Edwards scheme, and prelung transplantation evaluation data were compared between the groups. RESULTS: 38 patients with fibrotic ILDs were included, the majority (21) with idiopathic pulmonary fibrosis. Of the 38 patients, 18 had severe PH, 13 had mild/moderate PH and 7 had no PH by RHC. 16 of 38 patients had severe pulmonary arterial vasculopathy including vascular occlusion with intimal fibrosis and/or plexiform lesions. There were no correlations between mPAP and lung diffusion with the severity of pulmonary arterial pathological grade (Spearman's rho=0.14, p=0.34, rho=0.11, p=0.49, respectively). CONCLUSIONS: Patients with end stage ILD had severe pulmonary arterial vasculopathy in their explanted lungs irrespective of the presence and/or severity of PH as measured by RHC. These findings suggest that advanced pulmonary arterial vasculopathy is common in patients with advanced fibrotic ILD and may develop prior to the clinical detection of PH by RHC.
Subject(s)
Hypertension, Pulmonary/etiology , Lung Diseases, Interstitial/surgery , Lung Transplantation , Postoperative Complications/etiology , Pulmonary Artery/pathology , Aged , Female , Humans , Male , Middle Aged , Pneumonectomy , Retrospective Studies , Severity of Illness IndexABSTRACT
BACKGROUND AND PURPOSE: Head positioning is an important aspect for surgical planning in any cranial procedure. However, in neurointerventional cases, this is an afterthought due to advances in biplane imaging. We aim to present that the concept of head positioning may be applied to neurointerventional procedures to obtain optimal working projections to aide in the treatment of neurovascular pathology. METHODS: The operative log of the senior author was reviewed between 2016 and 2019. Seventeen patients were identified who required readjustment of head position to allow for ideal working projection during treatment. The reports and imaging of these patients were reviewed and categorized based on repositioning adjustments applied. RESULTS: Three specific head adjustments were performed to obtain working projections using biplanar angiography: head flexed position, head extended position, or extended-tilt positioning. All patients underwent endovascular coiling treatment for a variety of intracranial aneurysms. CONCLUSION: In select cases, ideal views of vascular pathology can be difficult to obtain due to limitations of biplane rotation or patient-specific anatomy. Simple maneuvers in head positioning can be done to achieve better working projections for optimized endovascular treatment.
Subject(s)
Brain/diagnostic imaging , Head/diagnostic imaging , Imaging, Three-Dimensional/methods , Neuroimaging/methods , Patient Positioning/methods , Cerebral Angiography/methods , Endovascular Procedures/methods , Humans , Intracranial Aneurysm/diagnostic imaging , Intracranial Aneurysm/surgery , Treatment OutcomeABSTRACT
AIM: The objective was to study the long-term (lifetime) cost effectiveness of four different hepatitis C virus (HCV) treatment models of care (MOC) with directly acting antiviral drugs. METHODS: A cohort Markov model-based probabilistic cost-effectiveness analysis (CEA) was undertaken extrapolating to up to 30 years from cost and outcome data collected from a primary study involving a real-life Australian cohort. In this study, noncirrhotic patients treated for HCV from 1 March 2016 to 28 February 2017 at four major public hospitals and liaising sites in South Australia were studied retrospectively. The MOC were classified depending on the person providing patient workup, treatment and monitoring into MOC1 (specialist), MOC2 (mixed specialist and hepatitis nurse), MOC3 (hepatitis nurse) and MOC4 (general practitioner, GP). Incremental costs were estimated from the Medicare perspective. Incremental outcomes were estimated based on the quality-adjusted life years (QALY) gained by achieving a sustained virological response. A cost-effectiveness threshold of Australian dollar 50 000 per QALY gained, the implicit criterion used for assessing the cost-effectiveness of new pharmaceuticals and medical services in Australia was assumed. Net monetary benefit (NMB) estimates based on this threshold were calculated. RESULTS: A total of 1373 patients, 64% males, mean age 50 (SD ±11) years, were studied. In the CEA, MOC4 and MOC2 clearly dominated MOC1 over 30 years with lower costs and higher QALYs. Similarly, NMB was the highest in MOC4, followed by MOC2. CONCLUSION: Decentralized care using GP and mixed consultant nurse models were cost-effective ways of promoting HCV treatment uptake in the setting of unrestricted access to new antivirals.
Subject(s)
Hepatitis C, Chronic , Hepatitis C , Aged , Antiviral Agents/therapeutic use , Australia/epidemiology , Cost-Benefit Analysis , Female , Hepacivirus , Hepatitis C/drug therapy , Hepatitis C, Chronic/diagnosis , Hepatitis C, Chronic/drug therapy , Hepatitis C, Chronic/epidemiology , Humans , Male , Markov Chains , Middle Aged , National Health Programs , Quality-Adjusted Life Years , Retrospective Studies , South Australia/epidemiologyABSTRACT
BACKGROUND: Smartphone applications (apps) are being increasingly utilized in the health care arena to improve patient care and outcomes. OBJECTIVE: To further demonstrate the ability of a smartphone app to improve patient compliance with preoperative instructions and to decrease the number of last-minute surgery cancellations. METHODS: Patients undergoing spine surgery were prospectively accrued. Smartphone app users were compared to non-app users. Patient adherence with preoperative instructions as well as last-minute surgery cancellations were analyzed. RESULTS: All 85 app users adhered to preoperative instructions according to the acknowledgements sent to the web portal, and there were no cancelled surgeries. Among the 89 non-app users, there were five cancelled surgeries (5.6%). CONCLUSIONS: We demonstrate the ability of a smartphone application to improve patient adherence with preoperative instructions and decrease last-minute surgery cancellations.
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Revision lumbar discectomy, given the disruption of anatomic planes, can be a more technically complicated operation. Historically, it may have higher complication rates than first-time microdiscectomy. Recently, minimally invasive tubular discectomy (MITD) has been reported as an equivalent treatment to traditional approaches and may have better utility for revision surgery. A retrospective review of MITDs performed by the senior surgeon (F.A.S.) on 42 patients with single-level, recurrent disk herniation was analyzed. Surgical technique, preoperative and postoperative visual analogue score, modified Macnab criteria, and complication rate were compared with similar patient series in the literature. One case is reviewed and the technique is described in detail. There were no significant differences across age (49.5±14.1), sex, or obesity status. Visual analogue scores improved significantly from 7.24±1.75 to 2.45±2.12 (P<0.001). Successful clinical outcome (excellent or good Macnab score) was reported in 83.3% of patients. There were no postoperative complications, including dural tears or wound infections: fewer than any reported series of this size to date. MITD can be safely performed for revision discectomies with low morbidity. A paramedian approach helps to decrease the exposure to preexisting scar tissue and may offer a significant advantage over the traditional midline approach to treat recurrent disk herniation.
Subject(s)
Diskectomy , Lumbar Vertebrae/surgery , Minimally Invasive Surgical Procedures/adverse effects , Postoperative Complications/etiology , Reoperation/adverse effects , Adult , Aged , Diskectomy/adverse effects , Diskectomy/methods , Female , Humans , Male , Middle Aged , Minimally Invasive Surgical Procedures/methods , Reoperation/methods , Retrospective StudiesABSTRACT
BACKGROUND: An isolated, unilateral fracture of the C1 lateral mass is a rare condition that has been only minimally described in the literature. Historically, these fractures have predominantly been managed conservatively with either external immobilization or traction. CASE DESCRIPTION: We review the literature and present 2 patients that presented after failing conservative management, but demonstrated excellent clinical outcomes after surgical treatment. CONCLUSIONS: After failure of conservative management, unilateral sagittal split fractures may be safely and effectively managed with unilateral open reduction and placement of a lag screw.
Subject(s)
Cervical Atlas/injuries , Cervical Atlas/surgery , Fracture Fixation, Internal , Spinal Fractures/surgery , Aged , Cervical Atlas/diagnostic imaging , Humans , Male , Middle Aged , Spinal Fractures/diagnostic imaging , Tomography, X-Ray Computed , Treatment OutcomeABSTRACT
BACKGROUND: Smartphone applications (apps) in the health care arena are being increasingly developed with the aim of benefiting both patients and their physicians. The delivery of adequate instructions both before and after a procedure or surgery is of paramount importance in ensuring the best possible outcome for patients. OBJECTIVE: To demonstrate that app-based instructions with built-in reminders may improve patient understanding and compliance and contribute to reducing the number of surgery cancellations and postoperative complications and readmissions. METHODS: We prospectively accrued 56 patients undergoing routine neurosurgery procedures who subsequently downloaded the app. The median age was 54 (range 27-79). Patients were followed for successful registration and use of the app, compliance with reading instructions before and after surgery, and sending pain scores and/or wound images. The number of surgeries cancelled, postoperative complications, 30-d readmissions, and phone calls for surgery-related questions were examined. RESULTS: Fifty-four of the 56 patients successfully registered, downloaded, and used the app and read and complied with instructions both before and after surgery. There were no cancelled surgeries. There was 1 postoperative complication. There were no readmissions. Eight of the 54 patients (14.8%) called the office on a single occasion for a surgery related question. CONCLUSION: We demonstrate the utility of a smartphone application in the perioperative neurosurgical care setting with regard to patient compliance and satisfaction as well as surgery cancellations and readmissions. Further study of a larger number of patients with a control group is warranted.
Subject(s)
Mobile Applications , Neurosurgical Procedures , Patient Compliance , Patient Satisfaction , Perioperative Care , Academic Medical Centers , Adult , Aged , Female , Humans , Male , Middle Aged , Patient ReadmissionABSTRACT
OBJECTIVE: Tandem cervical and lumbar spinal stenosis (TSS) is classically described as intermittent claudication, gait disturbance, and clinical findings of mixed myelopathy and polyradiculopathy. Rarely, patients can present with TSS manifesting in isolated lumbar pain. Several reports have demonstrated improved lumbar back pain and radiculopathy after decompressive cervical spine procedures. We present six patients with dramatic resolution of lumbar spine related symptoms after decompression of the cervical spinal cord despite presenting solely with lower back complaints. METHODS: Clinical records of the senior author (F.A.S.) gathered from April 2006 to March 2013 were retrospectively reviewed identifying six patients presenting solely with lumbar symptoms and diagnosed with TSS based on history and physical examination. RESULTS: Six patients with a mean age of 55 (range 39 to 60) presented with solely lower back symptoms and clinical findings suspicious for TSS. Mean follow-up time for all patients was 12 months (range three to 27 months, median 11.5 months). Three patients underwent a cervical procedure as the principal operation, while the remainder had the lumbar spine decompressed initially. All patients that underwent a cervical procedure initially experienced a dramatic decrease or complete resolution of their preoperative lower back pain and radiculopathy (mean preoperative VAS of 6.7 vs. 3.7 postoperative). The remainder of patients with persistent lumbar symptoms resolved after a subsequent cervical operation. CONCLUSION: Patients presenting with lumbar symptoms out of proportion to imaging require further investigation. We highlight the resolution of lumbar symptoms after a cervical procedure in a select group of patients presenting with lone lower back complaints. In patients presenting with symptoms disproportionate to lumbar imaging, treatment of cervical pathology may provide robust long-term relief of the initial lumbar-related presentation.
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OBJECTIVES: Novel specialty biopharmaceuticals hold promise for patients living with complex and chronic conditions. However, high research and development costs, special handling, and other necessary enhancements to patient support programs all contribute to frequently higher prices for these products. This study sought to assess the value of specialty pharmaceuticals through an examination of the clinical, functional, and economic benefits of these treatments for the top 3 disease areas by pharmaceutical spend: rheumatoid arthritis (RA), multiple sclerosis (MS), and breast cancer (BC). STUDY DESIGN: Systematic literature review. METHODS: A systematic review of market research and cost-effectiveness articles was conducted for each disease area to assess clinical, functional, and economic outcomes associated with specialty medicine treatments versus the previous standard of care. RESULTS: All RA clinical (American College of Rheumatology) and functional (Health Assessment Questionnaire) outcome articles were classified as positive. The median cost-effectiveness ratio was $38,900 per quality-adjusted life year (QALY). All MS clinical outcome (relapse rate) articles were positive. The MS functional outcome (Expanded Disability Status Scale) findings were less conclusive. The median cost-effectiveness ratio was $248,000 per QALY. The majority of BC articles yielded statistically inconclusive results for survival. All functional outcome (Quality of Life Questionnaire- Core 30) articles were positive. The median cost-effectiveness ratio was $51,900 per QALY. CONCLUSIONS: Novel specialty therapies hold promise for arresting disease progression and improving quality of life for the 3 conditions associated with the highest specialty pharmaceutical spend. These findings demonstrate a strong value proposition for specialty pharmaceuticals, and suggest even greater potential individual patient benefit with consideration of patient heterogeneity.
Subject(s)
Anti-Inflammatory Agents/therapeutic use , Antineoplastic Agents/therapeutic use , Antirheumatic Agents/therapeutic use , Arthritis, Rheumatoid/drug therapy , Breast Neoplasms/drug therapy , Multiple Sclerosis/drug therapy , Anti-Inflammatory Agents/economics , Antineoplastic Agents/economics , Antirheumatic Agents/economics , Arthritis, Rheumatoid/economics , Breast Neoplasms/economics , Cost-Benefit Analysis , Drug Costs , Female , Humans , Multiple Sclerosis/economicsABSTRACT
PURPOSE OF REVIEW: Chronic obstructive pulmonary disease (COPD) is caused by a mixture of small airway disease (obstructive bronchitis) and parenchymal lung tissue destruction (emphysema). The relative contributions of these two pathologic states vary from person to person. Having the ability to phenotype patients into predominately small airways disease or emphysema may affect the clinical management. RECENT FINDINGS: Pathologic studies have shown that the progression of COPD from Global Initiative for Chronic Obstructive Lung Disease stages 0 to 4 is most strongly associated with small airway wall thickening as a result of lung repair or remodeling. The narrowing and loss of small airways occurs prior to emphysematous destruction. There is an increase in the amount of neutrophils and CD8⺠T lymphocytes (cells that induce apoptosis and necrosis) in the small airways in COPD. Small airways disease can be identified on pulmonary function testing, using multiple nitrogen breath washout testing, indirectly through high-resolution chest computed tomography (CT) imaging or MRI, or directly by using microCT of resected lung tissue. There may be increased mortality in advanced COPD and concomitant small airway disease. There are newer methods to deliver respiratory therapies to reach the small airways. SUMMARY: The current techniques utilized to assess patients for small airway disease need to be improved, so clinicians can more effectively phenotype patients with COPD and small airways disease. This will allow new therapies that target the small airways to be developed and tested, and positively impact on the natural progression of COPD.
Subject(s)
Lung/pathology , Pulmonary Disease, Chronic Obstructive/mortality , Pulmonary Disease, Chronic Obstructive/pathology , Disease Progression , Humans , Lung/physiopathology , Pulmonary Disease, Chronic Obstructive/physiopathology , Respiratory Function Tests , Tomography, X-Ray ComputedABSTRACT
OBJECTIVE: To determine the ideal interval to image acquisition after IV injection of sodium fluoride F 18 ((18)F-NaF) and evaluate biodistribution of the radiopharmaceutical in clinically normal skeletally immature dogs. ANIMALS: 4 female dogs. PROCEDURES: Each dog was anesthetized for evaluation with a commercial hybrid positron emission tomography (PET)-CT instrument. A low-radiation dose, whole-body CT scan was acquired first. An IV injection of (18)F-NaF (0.14 mCi/kg) was administered, and a dynamic PET scan centered over the heart and liver was acquired during a period of 120 minutes. Uptake of (18)F-NaF in the blood pool, soft tissues, and skeletal structures was evaluated via region of interest analysis to derive standardized uptake values and time-activity curves, which were used to determine the optimal postinjection time for skeletal image acquisition. Biodistribution was also assessed from a final whole-body PET-CT scan acquired after the dynamic scan. RESULTS: Time-activity curves revealed a rapid decrease in the amount of radiopharmaceutical in the blood pool and soft tissues and a rapid increase in the amount of radiopharmaceutical in bones soon after injection. At 50 minutes after injection, the greatest difference in uptake between soft tissues and bones was detected, with continued subtle increase in uptake in the bones. Uptake of (18)F-NaF was slightly increased at growth plates and open ossification centers, compared with that at other parts of the bone. CONCLUSIONS AND CLINICAL RELEVANCE: At 50 minutes after IV injection of (18)F-NaF at the dose evaluated, PET-CT yielded excellent bone-to-background ratio images for evaluation of the skeletal system in dogs.