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The benefit of combined treatment with intravenous thrombolysis before endovascular thrombectomy in patients with acute ischaemic stroke caused by large vessel occlusion remains unclear. We hypothesised that the clinical outcomes of patients with stroke with large vessel occlusion treated with direct endovascular thrombectomy within 4·5 h would be non-inferior compared with the outcomes of those treated with standard bridging therapy (intravenous thrombolysis before endovascular thrombectomy).DIRECT-SAFE was an international, multicentre, prospective, randomised, open-label, blinded-endpoint trial. Adult patients with stroke and large vessel occlusion in the intracranial internal carotid artery, middle cerebral artery (M1 or M2), or basilar artery, confirmed by non-contrast CT and vascular imaging, and who presented within 4·5 h of stroke onset were recruited from 25 acute-care hospitals in Australia, New Zealand, China, and Vietnam. Eligible patients were randomly assigned (1:1) via a web-based, computer-generated randomisation procedure stratified by site of baseline arterial occlusion and by geographic region to direct endovascular thrombectomy or bridging therapy. Patients assigned to bridging therapy received intravenous thrombolytic (alteplase or tenecteplase) as per standard care at each site; endovascular thrombectomy was also per standard of care, using the Trevo device (Stryker Neurovascular, Fremont, CA, USA) as first-line intervention. Personnel assessing outcomes were masked to group allocation; patients and treating physicians were not. The primary efficacy endpoint was functional independence defined as modified Rankin Scale score 0-2 or return to baseline at 90 days, with a non-inferiority margin of -0·1, analysed by intention to treat (including all randomly assigned and consenting patients) and per protocol. The intention-to-treat population was included in the safety analyses. The trial is registered with ClinicalTrials.gov, NCT03494920, and is closed to new participants.Between June 2, 2018, and July 8, 2021, 295 patients were randomly assigned to direct endovascular thrombectomy (n=148) or bridging therapy (n=147). Functional independence occurred in 80 (55%) of 146 patients in the direct thrombectomy group and 89 (61%) of 147 patients in the bridging therapy group (intention-to-treat risk difference -0·051, two-sided 95% CI -0·160 to 0·059; per-protocol risk difference -0·062, two-sided 95% CI -0·173 to 0·049). Safety outcomes were similar between groups, with symptomatic intracerebral haemorrhage occurring in two (1%) of 146 patients in the direct group and one (1%) of 147 patients in the bridging group (adjusted odds ratio 1·70, 95% CI 0·22-13·04) and death in 22 (15%) of 146 patients in the direct group and 24 (16%) of 147 patients in the bridging group (adjusted odds ratio 0·92, 95% CI 0·46-1·84).We did not show non-inferiority of direct endovascular thrombectomy compared with bridging therapy. The additional information from our study should inform guidelines to recommend bridging therapy as standard treatment.Australian National Health and Medical Research Council and Stryker USA.

Background Blister aneurysms (BA) are high risk cerebrovascular lesions accounting for 1% of intracranial aneurysms. The defective vessel wall and broad-based neck make this clinical entity difficult to treat, with high rates of re-rupture and mortality in patients presenting with acute subarachnoid haemorrhage. Blister aneurysms pose substantial challenges for both endovascular and microsurgical management.Objective To evaluate endovascular and microsurgical outcomes in intracranial blister aneurysm management across two tertiary hospitals.Methods A review of two tertiary hospitals with a systematic imaging database search for term of “blister” in modalities from January 2010 to October 2022. Operation reports were screened for the 5-year period since cerebral angiogram reports transitioned to surgical database. Identified reports were screened and reviewed for confirmed diagnosis by consultant neuroradiologist.Results 21 cases of blister aneurysms managed at respective facilities were included. 16 cases (76%) were managed endovascularly – all with flow diversion stents. 4 cases (19%) were managed surgically – 2 with primary clipping, and 2 wrap and clipping. 1 case was managed conservatively (5%). Clinical outcomes were discharge disposition, aneurysm exclusion and post-operative complications.Conclusion BAs have challenging considerations with high mortality and morbidity. Endovascular treatment is less invasive option with lower rates of intraoperative rupture and mortality. Patients discharged home were comparable. Commencement of dual anti-platelet therapy was safe in patients with flow diversion stents despite sub-arachnoid blood volume. Management of blister aneurysms is complex. Endovascular treatment shows promise for acute treatment but careful consideration of antithrombotic regime and requirement for further surgery should be considered.

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Introduction Stroke caused by basilar artery occlusion (BAO) is a rare but potentially devastating neurological condition, with poor outcomes and high mortality rates, approaching 70-90%. Success of intravenous and intra-arterial thrombolysis in BAO is variable, leading to Endovascular Therapy (EVT) being utilized to a greater degree in this clinical setting. We investigate the use of EVT in BAO with regard to success of revascularization and patient mortality/outcome. Methods Retrospective patient data was collected from medical records and radiology information systems. Results Twenty-eight patients underwent EVT for BAO between 2010-17, with successful revascularization in 21/28 (75%) and an inpatient mortality rate of 39%. Successful revascularization correlated with lower mortality (P = 0.0001). Better revascularization and mortality rates occurred between 2013-17 (P = 0.007, 0.04). An average time to EVT of 16.8 hours was observed between 2010-17 but this did not correlate significantly with increased mortality. Basilar stenting correlated with lower revascularization, higher mortality and basilar artery reocclusion post EVT (P = 0.021, 0.022, 0.022). EVT times over 2 and 2.5 hours respectively associated with lower revascularization rates and higher mortality (P = 0.04, 0.022). Higher mortality was seen with intra-procedural complications and symptomatic intracranial haemorrhage, non-posterior circulation infarction and basilar artery reocclusion post EVT (P = 0.016, 0.03, 0.016, 0.016). Basilar atheroma correlated with intra-procedural complications and EVT times over 2 hours (P = 0.038, 0.004). Conclusion Within the limitations of an underpowered study, we observed a benefit of EVT in acute BAO. With future multicentre trials, EVT will likely become the standard of care in acute BAO.

Background Oral immunotherapy (OIT) successfully desensitizes patients with food allergies, but the immune mechanisms mediating its efficacy remain obscure. Objectives We tested the hypothesis that allergen-specific regulatory T (Treg) cell function is impaired in food allergy and is restored by anti-IgE antibody (omalizumab)-supplemented OIT. Methods Peanut-specific T effector (Teff) and Treg cell proliferative responses, activation markers and cytokine expression were analysed by flow cytometry in 13 peanut-allergic subjects before the start of omalizumab-supplemented OIT and periodically in some subjects thereafter for up to 2 years. Peripheral blood regulatory T cells (Treg cells) were analysed for their peanut-specific suppressor function before and at 1 year following OIT. This study was registered on ClinicalTrials.gov (NCT01290913). Results Proliferation of allergen-specific Teff and Treg cells precipitously declined following the initiation of omalizumab therapy prior to OIT, followed by partial recovery after the initiation of OIT. At baseline, peanut-specific Treg cells exhibited a Th2 cell-like phenotype, characterized by increased IL-4 expression, which progressively reversed upon OIT. Peanut-specific Treg cell suppressor activity was absent at the start of omalizumab/OIT therapy but became robust following OIT. Absent peanut-specific Treg cell function could also be recovered by the acute blockade of IL-4/IL-4R receptor signalling in Treg cells, which inhibited their IL-4 production. Conclusions and clinical relevance OIT supplemented by omalizumab promotes allergen desensitization through an initial omalizumab-dependent step that acutely depletes allergen-reactive T cells, followed by an increase in allergen-specific Treg cell activity due to the reversal of their Th2 cell-like programme. Improved Treg cell function may be a key mechanism by which OIT ameliorates food allergy.

Objective To assess the feasibility and efficacy of implementing a treat‐to‐target approach versus usual care in a US‐based cohort of rheumatoid arthritis patients. Methods In this behavioral intervention trial, rheumatology practices were cluster‐randomized to provide treat‐to‐target care or usual care. Eligible patients with moderate/high disease activity (Clinical Disease Activity Index [CDAI] score >10) were followed for 12 months. Both treat‐to‐target and usual care patients were seen every 3 months. Treat‐to‐target providers were to have monthly visits with treatment acceleration at a minimum of every 3 months in patients with CDAI score >10; additional visits and treatment acceleration were at the discretion of usual care providers and patients. Coprimary end points were feasibility, assessed by rate of treatment acceleration conditional on CDAI score >10, and achievement of low disease activity (LDA; CDAI score ≤10) by an intent‐to‐treat analysis. Results A total of 14 practice sites per study arm were included (246 patients receiving treat‐to‐target and 286 receiving usual care). The groups had similar baseline demographic and clinical characteristics. Rates of treatment acceleration (treat‐to‐target 47% versus usual care 50%; odds ratio [OR] 0.92 [95% confidence interval (95% CI) 0.64, 1.34]) and achievement of LDA (treat‐to‐target 57% versus usual care 55%; OR 1.05 [95% CI 0.60, 1.84]) were similar between groups. Treat‐to‐target providers reported patient reluctance and medication lag time as common barriers to treatment acceleration. Conclusion This study is the first to examine the feasibility and efficacy of a treat‐to‐target approach in typical US rheumatology practice. Treat‐to‐target care was not associated with increased likelihood of treatment acceleration or achievement of LDA, and barriers to treatment acceleration were identified.

Background and hypothesis Intravenous thrombolysis with alteplase remains standard care prior to thrombectomy for eligible patients within 4.5 h of ischemic stroke onset. However, alteplase only succeeds in reperfusing large vessel arterial occlusion prior to thrombectomy in a minority of patients. We hypothesized that tenecteplase is non-inferior to alteplase in achieving reperfusion at initial angiogram, when administered within 4.5 h of ischemic stroke onset, in patients planned to undergo endovascular therapy. Study design EXTEND-IA TNK is an investigator-initiated, phase II, multicenter, prospective, randomized, open-label, blinded-endpoint non-inferiority study. Eligibility requires a diagnosis of ischemic stroke within 4.5 h of stroke onset, pre-stroke modified Rankin Scale≤3 (no upper age limit), large vessel occlusion (internal carotid, basilar, or middle cerebral artery) on multimodal computed tomography and absence of contraindications to intravenous thrombolysis. Patients are randomized to either IV alteplase (0.9 mg/kg, max 90 mg) or tenecteplase (0.25 mg/kg, max 25 mg) prior to thrombectomy. Study outcomes The primary outcome measure is reperfusion on the initial catheter angiogram, assessed as modified treatment in cerebral infarction 2 b/3 or the absence of retrievable thrombus. Secondary outcomes include modified Rankin Scale at day 90 and favorable clinical response (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0–1) at day 3. Safety outcomes are death and symptomatic intracerebral hemorrhage. Trial registration ClinicalTrials.gov NCT02388061

Introduction In this study we evaluated the suitability of a caregiver-reported functional measure, the Pediatric Evaluation of Disability Inventory-Computer Adaptive Test (PEDI-CAT), for children and young adults with spinal muscular atrophy (SMA). Methods PEDI-CAT Mobility and Daily Activities domain item banks were administered to 58 caregivers of children and young adults with SMA. Rasch analysis was used to evaluate test properties across SMA types. Results Unidimensional content for each domain was confirmed. The PEDI-CAT was most informative for type III SMA, with ability levels distributed close to 0.0 logits in both domains. It was less informative for types I and II SMA, especially for mobility skills. Item and person abilities were not distributed evenly across all types. Conclusions The PEDI-CAT may be used to measure functional performance in SMA, but additional items are needed to identify small changes in function and best represent the abilities of all types of SMA. Muscle Nerve 54: 1097-1107, 2016.

Intravenous infusion of alteplase is used for thrombolysis before endovascular thrombectomy for ischemic stroke. Tenecteplase, which is more fibrin-specific and has longer activity than alteplase, is given as a bolus and may increase the incidence of vascular reperfusion.We randomly assigned patients with ischemic stroke who had occlusion of the internal carotid, basilar, or middle cerebral artery and who were eligible to undergo thrombectomy to receive tenecteplase (at a dose of 0.25 mg per kilogram of body weight; maximum dose, 25 mg) or alteplase (at a dose of 0.9 mg per kilogram; maximum dose, 90 mg) within 4.5 hours after symptom onset. The primary outcome was reperfusion of greater than 50% of the involved ischemic territory or an absence of retrievable thrombus at the time of the initial angiographic assessment. Noninferiority of tenecteplase was tested, followed by superiority. Secondary outcomes included the modified Rankin scale score (on a scale from 0 [no neurologic deficit] to 6 [death]) at 90 days. Safety outcomes were death and symptomatic intracerebral hemorrhage.Of 202 patients enrolled, 101 were assigned to receive tenecteplase and 101 to receive alteplase. The primary outcome occurred in 22% of the patients treated with tenecteplase versus 10% of those treated with alteplase (incidence difference, 12 percentage points; 95% confidence interval [CI], 2 to 21; incidence ratio, 2.2; 95% CI, 1.1 to 4.4; P=0.002 for noninferiority; P=0.03 for superiority). Tenecteplase resulted in a better 90-day functional outcome than alteplase (median modified Rankin scale score, 2 vs. 3; common odds ratio, 1.7; 95% CI, 1.0 to 2.8; P=0.04). Symptomatic intracerebral hemorrhage occurred in 1% of the patients in each group.Tenecteplase before thrombectomy was associated with a higher incidence of reperfusion and better functional outcome than alteplase among patients with ischemic stroke treated within 4.5 hours after symptom onset. (Funded by the National Health and Medical Research Council of Australia and others; EXTEND-IA TNK ClinicalTrials.gov number, NCT02388061 .).

To document and improve the quality of our chronic pain management using population management methods.An analytic registry was developed, and all new patients were enrolled for 12 months. Patient demographics, standardized pain and function measures, and treatments were recorded. Usual care was provided. The registry was used to organize care and analyze management and outcomes.Of 454 total patients, only 154 (34%) completed a 6-month cycle of care. High no-show rates were documented for follow-up appointments for several reasons. The majority of 6-month completers showed improved pain levels.This quality improvement project identified assessment and care gaps and led to improvements. An ongoing need to improve measures of pain and function was documented.

BackgroundThe recent literature pertaining to delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage has downplayed the role of angiographic vasospasm. However, it is our hypothesis that angiographic vasospasm has a significant pathophysiological role in this disease. We undertook an observational radiographic study of patients who presented in a delayed manner (>72 h from ictus) with evidence of severe angiographic vasospasm on initial angiography in order to describe an apparent association between vasospasm and infarct location.MethodsThis was a retrospective study of consecutive patients treated at our unit. Initial, subsequent, and follow-up cross-sectional imaging with CT or MRI was analyzed in conjunction with initial angiography. Sites of angiographic narrowing, angiographic hypoperfusion, and subsequent sites of infarction were assessed.ResultsThirteen patients (6 women, 7 men) of mean age 49 years were assessed. Mean time to presentation was 6 days. All had severe angiographic vasospasm. Nine of the 13 patients suffered infarction; the infarcts in seven of the nine patients were large. There was correlation between sites of angiographic narrowing and infarction in all cases and eight of the nine cases showed angiographic hypoperfusion in a location corresponding to eventual infarct location.ConclusionsSevere angiographic vasospasm may be linked to infarction in patients who present late. These infarcts are mostly large despite maximal treatment. We question the notion that proximal vasospasm has a minor role in delayed ischemia.

Background: Documenting specific knowledge and attitudes about HIV in the culturally diverse nation of Solomon Islands is essential to inform locally targeted public health responses. As part of a large capacity-strengthening project at Atoifi Adventist Hospital in East Kwaio, Solomon Islands, researchers, using a 'learn-by-doing' process, worked with participants in public health research methods. Methods: Overall, 43 people attended research capacity building workshops in 2011; eight joined the HIV study group. A cross-sectional survey including semi-structured interviews on HIV was conducted by the group. In February 2014, a hospital administrator was interviewed about how the 2011 study informed local HIV responses. Results: Of the 53 survey participants, 64% self-assessed as having little or no HIV knowledge, but 90% knew HIV could be transmitted between men and women during sex. Less than 50% knew HIV could be transmitted between two men having sex, 45% thought HIV could be transmitted by mosquitoes and 55% agreed condoms help protect from HIV. Most participants reported negative attitudes towards people with HIV. Three years later the health administrator reported ad hoc responses to HIV because of low HIV prevalence, increasing noncommunicable diseases, staff turnover and resource shortages. Discussion: This HIV study was used to strengthen research skills in local health professionals and community members in Solomon Islands. It showed that community members require accurate information about HIV transmission and that entrenched stigma is an issue. Although results provided local evidence for local response, ongoing health system challenges and little local HIV transmission meant HIV services remain rudimentary.

Stomal varices can develop in patients with ostomy in the setting of portal hypertension. Bleeding from the stomal varices is uncommon, but the consequences can be disastrous. Haemorrhage control measures that have been described in the literature include pressure dressings, stomal revision, mucocutaneous disconnection, variceal suture ligation and sclerotherapy. These methods may only serve to temporise the stomal bleeding and have a high risk of recurrent bleed. While transjugular intrahepatic porto-systemic shunting has been advocated as the treatment of choice in patients with underlying liver cirrhosis, histoacryl glue or coil embolisation has been successfully employed in patients who are not suitable candidates for TIPS. Direct percutaneous embolisation of the dominant varices was performed successfully under ultrasound and fluoroscopic guidance in two patients using a combination of coils and histoacryl glue. While transjugular intrahepatic porto-systemic shunting has been advocated as the treatment of choice in patients with underlying liver cirrhosis, histoacryl glue or coil embolisation has been successfully employed in patients who are not suitable candidates for TIPS. Direct percutaneous embolisation is a safe and effective treatment for stomal varices in selected patients.

Background Portal vein embolization (PVE) induces compensatory hypertrophy of the future liver remnant volume (FLRV) to improve the safety of major liver surgery by reducing the risk of post-operative liver failure. The aim was to describe our experience of PVE for patients with large or multifocal malignant liver tumours who initially were deemed unresectable. Methods Perioperative data were retrieved from a prospective database and computed tomographic scans were retrospectively reviewed to calculate volume changes and the degree of liver hypertrophy following PVE. Results PVE was successful in 23 out of 25 patients and resulted in a change in the mean estimated FLRV from 585 to 788 mL following PVE. This represented a 35% increase in the remnant liver parenchymal volume post-embolization (P < 0.01). The procedure was well tolerated and did not compromise the surgical resection in any patient. Nineteen patients went on to have a liver resection following PVE with an in-hospital mortality of 16% (3 out of 19) and a 42% morbidity rate. After a mean follow-up of 31 months (1–130 months), 32% (6 out of 19) of patients are alive and 4 of these (21%) are completely disease-free. Conclusions PVE results in an increase in the FLRV prior to major hepatectomy. Failure to develop hypertrophy following PVE is a surrogate marker for underlying liver dysfunction. PVE is safe and may increase the pool of patients suitable for liver resection. Long-term survival is similar to those not requiring embolization prior to liver resection.

Objective To examine prescribing practices in the use of biologic and nonbiologic disease-modifying antirheumatic drugs (DMARDs) to treat patients with rheumatoid arthritis (RA), before and after publication of the American College of Rheumatology (ACR) treatment recommendations. Methods Biologics-naive RA patients under the care of a rheumatologist in the US were identified from the Consortium of Rheumatology Researchers of North America registry. Patients were included if their visits occurred prior to and/or at least 6 months after publication of the ACR treatment recommendations (time periods of February 2002–June 2008 versus December 2008–December 2009). The population was divided into 2 mutually exclusive cohorts: 1) methotrexate (MTX) monotherapy users, and 2) multiple nonbiologic DMARD users. Initiation or dose escalation of biologic and nonbiologic DMARDs in response to active disease was assessed cross-sectionally and longitudinally in comparison to the ACR recommendations. The impact of the publication of the ACR recommendations on treatment practices was assessed using logistic regression, stratified by disease activity and adjusted for clustering of physicians and geographic region. Results After 1 visit, 24–37% of patients receiving MTX monotherapy who had moderate disease activity and a poor prognosis or high disease activity received care consistent with the ACR recommendations; after 2 visits, 34–56% of the MTX monotherapy group received care consistent with the recommendations. In the patients receiving multiple nonbiologic DMARDs, 31–47% of those with moderate or high disease activity received care consistent with the recommendations after 1 visit, and 43–51% received such care after 2 visits. Publication of the recommendations did not significantly change treatment patterns for those with active disease. Conclusion Substantial numbers of RA patients with active disease did not receive care consistent with the current ACR treatment recommendations. Innovative approaches to improve care are necessary.

Introduction In recent years, the American College of Rheumatology (ACR) has focused increasingly on the development, review, dissemination, and implementation of quality measures. To help position rheumatology providers as the leading force in defining the quality of rheumatology care, the ACR convened a Quality Measures White Paper Development Workgroup. This diverse workgroup’s charge included synthesizing the information most relevant to the ACR membership regarding quality measurement. As described in this manuscript, the workgroup ultimately participated in a consensus development initiative to craft a set of criteria for quality measures submitted to the ACR for approval. The criteria are intended to guide measure developers and discourage adoption of subpar measures. This White Paper is written for rheumatologists interested in quality measurement, groups undertaking quality measure development, and policy makers. It is organized into the following main sections: a brief introduction provides context and describes the ACR’s national role and positions; section 1 outlines quality measure domains and reviews measure attributes; and section 2 describes and reports results of an ACR workgroup–led process to develop specific criteria for ACR approval of quality measures.

The demands for reforming healthcare delivery are increasing from all quarters, owing to the fact that optimal disease outcomes are not being achieved and the costs of care are higher than necessary. Streamlining rheumatology practice is part of this priority. It is critical to improve chronic disease management at the practice and system levels to achieve these higher expectations for patients and disease populations. Examples of excellent rheumatic disease care within integrated health systems and individual practices suggest the type of thinking and action needed to achieve these results more generally. Rheumatologists need to understand the barriers to streamlining their practices, learn the continuous quality improvement methods required to do so and must begin these efforts now.

Objective.To evaluate the uses of quantitative disease activity scoring and a physician global assessment of disease activity for managing rheumatoid arthritis (RA) in rheumatology practice.Methods.The Global Arthritis Score (GAS) and a physician global assessment (Physician Global) were determined during each office visit for a community practice RA population. The GAS was calculated from patients’ self-reported pain, functional assessment, and tender joint count. The Physician Global was recorded on a 10-point visual analog scale. The correlation of these 2 disease activity measures was determined for the most recent office visit of 185 patients with RA, and the reasons for discordant results were identified by chart review.Results.The GAS and Physician Global were concordant for active or inactive disease in 126 of 185 patients (68%) and were discordant in 59 (32%). Forty-five of these discordant patients had a high GAS while their Physician Global indicated inactive disease. Their GAS values were high because of osteoarthritis, back pain, soft tissue rheumatism, and/or prior joint damage rather than active RA. The other 14 patients had a low GAS with an uncontrolled Physician Global for a variety of reasons.Conclusion.(1) An RA disease activity score and a quantitative Physician Global can be measured during rheumatology office visits to document patients’ disease status. (2) Disease activity scoring contributes valuable information, but should not replace the Physician Global in guiding RA patient management or reimbursement decisions.

A continuous quality improvement approach is proposed for the assessment and management of patients with rheumatoid arthritis (RA) based on scores on a one-page patient self-report multidimensional health assessment questionnaire (MDHAQ), without formal joint counts. The approach includes five simple steps before the patient is seen by the physician: (1) an MDHAQ is completed by every patient at every visit; (2) scores are calculated for patient function, pain, and global estimate, with options for a self-report joint count and other scales; (3) scores are entered on flow sheets with data from prior visits, which might also include laboratory and medication information; (4) scores are compiled into an index termed Routine Assessment of Patient Index Data (RAPID), analogous to a Disease Activity Score (DAS); (5) RAPID scores are classified to guide treatment decisions. RAPID 3 includes the three patient-reported outcome (PRO) measures in the RA Core Data Set - physical function, pain, and global estimate. RAPID 4 adds a self-report joint count, and RAPID 5, a physician global estimate. RAPID 3 can be calculated in about 10 seconds, RAPID 4 in about 19 seconds, and RAPID 5 in about 20 seconds. RAPID 3, RAPID 4, and RAPID 5 give similar results to distinguish active from control treatments in RA clinical trials, at levels similar to American College of Rheumatology or DAS improvement criteria, and are all correlated significantly with DAS28 (rho=0.62-0.64, P0.001). A proposed classification of RAPID scores, analogous to four DAS28 categories, includes: 'near remission' (0-1), 'low severity' (1.01-2), 'moderate severity' (2.01-4), and 'high severity' (4). RAPID scoring is feasible in standard clinical care to support continuous quality improvement.

Objective To review the 3-year performance of an established osteoporosis care service and consider further improvements in an effort to reduce fragility fractures. Methods Osteoporosis care has been coordinated for all willing and able patients with orthopedic fragility fractures in our health system by a nurse and medical director since 2003, using a guideline-based care algorithm and task management software. Patients were followed by telephone for 2 years to monitor their status and optimize adherence to treatment. Demographics, management recommendations, clinical data, and adherence to treatment were reviewed for the 2003–2005 patient population. Results Of 1,019 patients with fragility fractures, 61% underwent osteoporosis evaluation and treatment. The remainder included 15% who refused to participate and 24% who were unable to participate for various logistical and health reasons. More patients age >80 years were unwilling or unable to participate. Bone densities (dual x-ray absorptiometry [DXA]) were normal, low, or osteoporotic in 24%, 55%, and 21% of patients, respectively, and 60% of the osteoporotic group had ≥1 abnormal metabolic bone laboratory result. Only 17% of the total reported a previous fracture, and 47% had ever undergone DXA. Few experienced bone loss, a new fracture, or bisphosphonate intolerance during treatment. Conclusion An osteoporosis care service has coordinated care for every willing and able fragility fracture patient with positive outcomes. In addition, the results suggest a high priority for earlier proactive diagnosis and intervention of the at-risk population if fractures are to be reduced.

Objective To improve osteoporosis diagnosis and treatment of fragility fracture patient populations because osteoporosis care is provided infrequently to those patients, leaving them vulnerable to further fractures and increasing debility. Methods Osteoporosis experts from 11 US health systems participated in a clinical improvement project based on previously described successful osteoporosis care process redesigns. Participants were taught rapid cycle process improvement methods that are widely used in clinical improvement projects, and were supported in their efforts by the program coordinator. Measures of successful process development included establishing reliable referral from orthopedic fracture care to osteoporosis diagnosis and treatment, nurse coordination and monitoring of osteoporosis care, and use of process management software for registering patients and organizing work. Results Four sites were able to establish these critical referral and osteoporosis management processes. Two sites were partially successful in increasing orthopedic referrals to consultative care, but otherwise continued traditional care processes. Five were unsuccessful due to inability to implement 1 or more of these key process improvements. Conclusion Reliable osteoporosis care for fracture patients is possible if traditional practice processes are replaced with more effective, well-recognized approaches to chronic disease management.

BackgroundSurgical clipping and endovascular coiling yield similar functional outcomes for the treatment of saccular aneurysms of the anterior communicating (ACOM) artery. However, surgical treatment may be associated with greater rates of cognitive impairment due to injury of adjacent structures. We aimed to quantify the rates of injury (infarction/hemorrhage) for both clipping and coiling of ACOM aneurysms.MethodsThis was a retrospective dual-center radiological investigation of a consecutive series of patients with ruptured and unruptured ACOM aneurysms treated between January 2011 and October 2014. Post-treatment CT or MRI was assessed for new ischemic or hemorrhagic injury. Injury relating to the primary hemorrhage or vasospasm was differentiated. Univariate analysis using χ2 tests and multivariate analysis using binary logistic regression was used.Results66 patients treated with clipping were compared with 93 patients treated with coiling. 32/66 (48.5%) patients in the clipping group suffered treatment-related injury (31 ischemic, 1 hemorrhagic) compared with 4/93 (4.4%) patients in the coiling group (3 ischemic, 1 hemorrhagic) (pConclusionsClipping of ACOM aneurysms is associated with significantly higher rates of structural injury than coiling, and this may be a reason for superior cognitive outcomes in patients treated with coiling in previously published studies.

Objective To develop new processes that assure more reliable, population-based care of fragility fracture patients. Methods A 4-year clinical improvement project was performed in a multispecialty, community practice health system using evidence-based guidelines and rapid cycle process improvement methods (plan-do-study-act cycles). Results Prior to this project, appropriate osteoporosis care was provided to only 5% of our 1999 hip fracture patients. In 2001, primary physicians were provided prompts about appropriate care (cycle 1), which resulted in improved care for only 20% of patients. A process improvement pilot in 2002 (cycle 2) and full program implementation in 2003 (cycle 3) have assured osteoporosis care for all willing and able patients with any fragility fracture. Altogether, 58% of 2003 fragility fracture patients, including 46% of those with hip fracture, have had a bone measurement, have been assigned to osteoporosis care with their primary physician or a consultant, and are being monitored regularly. Only 19% refused osteoporosis care. Key process improvements have included using orthopedic billings to identify patients, referring patients directly from orthopedics to an osteoporosis care program, organizing care with a nurse manager and process management computer software, assigning patients to primary or consultative physician care based on disease severity, and monitoring adherence to therapy by telephone. Conclusion Reliable osteoporosis care is achievable by redesigning clinical processes. Performance data motivate physicians to reconsider traditional approaches. Improving the care of osteoporosis and other chronic diseases requires coordinated care across specialty boundaries and health system support.

Purpose: To report initial experience with intracranial vertebral artery (VA) and basilar artery (BA) percutaneous transluminal angioplasty (PTA) and stenting. Methods: Eleven patients (10 men; mean age 66 years, range 56–75) with intracranial 14 VA and 3 BA stenoses were managed from December 1997 through November 1999. All patients presented with vertebrobasilar ischemia (VBI) despite antiplatelet and anticoagulant therapy. Clinical presentations included visual disturbance (n = 8), dysarthria/dysphasia (n = 5), and vertigo (n = 5). Results: Five patients underwent PTA only of 7 lesions with a mean preprocedural stenosis of 80% (range 50%–90%) that was reduced to 54% (range 30%–70%) after dilation. Six patients received 9 stents, 2 for VA dissections, 3 for tandem lesions, and 1 for a BA lesion. There were no embolic strokes. Patients were followed by clinical evaluation and personal or telephone interviews. Over a mean 18-month follow-up (range 12–35), 8 (73%) patients remained asymptomatic, while 3 (27%) had permanent deficits, 2 related to the procedure and 1 owing to distal disease Conclusions: Intracranial VA or BA angioplasty and stenting alleviated symptoms in patients with vertebrobasilar ischemia despite best medical management and may prevent stroke.

Several thrombolytic agents for the treatment of acute ischaemic stroke have been examined; however, to date, only the i.v. administration of recombinant tissue plasminogen activator is licensed in Australia. Although no trials directly comparing intra-arterial and i.v. delivery of thrombolytics exist, intra-arterial thrombolysis has several potential advantages, including angiographic assessment of the thrombus and the site of occlusion and collateral circulation, improved recanalization, and delivery of higher local concentrations of thrombolytic agents and extending the therapeutic time window for treatment. We conducted a retrospective audit of our experience with the use of intra-arterial urokinase to treat acute ischaemic stroke at an Australian tertiary-care hospital between June 1993 and June 2003. We examined time from stroke onset to assessment, computerized tomography scan, cerebral angiography and thrombolysis, anatomical classification of intra-arterial thrombus, rates of symptomatic intracerebral haemorrhage, and clinical outcome at 3 months. We believe that in carefully selected individuals in appropriate centres of expertise, intra-arterial thrombolytic therapy holds great promise.

Essential thrombocythemia (ET) is a risk factor for ischemic stroke and, far more rarely, hemorrhage. We report the case of an untreated 32-year-old woman with a history of JAK2 V617F–positive ET with cerebellar and subarachnoid hemorrhages without evidence of sinus vein thrombosis. She was commenced on oral cytotoxic and antiplatelet therapy. This case report discusses the underlying mechanism of hemorrhagic thrombocythemia and the management dilemma presented by the recommended treatment implications.

Portal vein embolization (PVE) induces compensatory hypertrophy of the future liver remnant volume (FLRV) to improve the safety of major liver surgery by reducing the risk of post-operative liver failure. The aim was to describe our experience of PVE for patients with large or multifocal malignant liver tumours who initially were deemed unresectable.Perioperative data were retrieved from a prospective database and computed tomographic scans were retrospectively reviewed to calculate volume changes and the degree of liver hypertrophy following PVE.PVE was successful in 23 out of 25 patients and resulted in a change in the mean estimated FLRV from 585 to 788 mL following PVE. This represented a 35% increase in the remnant liver parenchymal volume post-embolization (P0.01). The procedure was well tolerated and did not compromise the surgical resection in any patient. Nineteen patients went on to have a liver resection following PVE with an in-hospital mortality of 16% (3 out of 19) and a 42% morbidity rate. After a mean follow-up of 31 months (1-130 months), 32% (6 out of 19) of patients are alive and 4 of these (21%) are completely disease-free.PVE results in an increase in the FLRV prior to major hepatectomy. Failure to develop hypertrophy following PVE is a surrogate marker for underlying liver dysfunction. PVE is safe and may increase the pool of patients suitable for liver resection. Long-term survival is similar to those not requiring embolization prior to liver resection.

Measuring healthcare processes and the outcomes of care is surprisingly a new idea, and a chasm exists regarding the perceived need for clinical measurement between health policy experts and government planners on the one hand and the providers of care on the other. This might be considered the “second quality chasm”. The train full of researchers, planners, and payers is miles down the tracks, while the train for the physicians who provide the care is just being loaded. In fact, many physicians aren’t convinced that this is a train they want to ride on. As an example, Medicare has developed the Physicians Quality Reporting Initiative (PQRI) to encourage physicians to begin reporting important quality indicators, but few are participating. Doing so not only requires time and resources, but it is not part of physicians’ training or self-expectations.

The authors of this book believe that advocating for the status quo is unacceptable. The assertion that we have “the best health system in the world” ignores copious statistical evidence to the contrary, as well as the less quantifiable but critically relevant stress and suffering of physicians and patients caught in the current chaos. Our challenge: getting from where we are to a better future by skillfully managing change.

Current medical education concentrates on the first skill set – what to do – but not so much on the rest. Being knowledgeable and being effective are equally necessary, and they are not the same. Truly great health care won’t be ours unless we work more in teams and systems, get all the stakeholders involved, including patients, and employ clinical improvement (PDSA) methods.

Our understanding of chronic diseases began to change at the dawn of the twentieth century and accelerated in the 1950s. Previously, individual physicians usually provided a diagnosis to explain the patient’s symptoms and an estimate of future problems and life expectancy – a prognosis. Diagnostic tests and treatments were limited by today’s standards. Patients expected little more from their physicians because this was the way it had always been, and the brighter future of more effective medicine was largely unrecognized. A physician’s esteem was derived from his “bedside manner,” wisdom, and the acuity of his diagnostic skills. I tell my patients that I have several well-controlled chronic diseases that my grandparents suffered with and died from when they were younger than my present age.

There is no shortage of proposals for mending the broken U.S. health system. Many can be set aside because they favor their advocates more than they solve critical problems for patients and society. Of those remaining, two will be the focus of this discussion, the Patient-centered Medical Home and System-based Health Care. These are generally presented as alternatives, but we suggest instead that improving delivery of care will require implementing the Medical Home in the context of broader system-based redesigns. This dual approach is most important for chronic disease management, the greatest challenge we face, and the subject of our book.

Raise your hand and count yourself lucky if you’ve made it through middle age without knowing someone who’s been knocked down by complications of (to name a few) obesity, arthritis, asthma, or heart disease.

Complex processes and systems are inherently unruly, as already discussed in Part II. Individuals and organizations that exist in such environments must either manage complexity, or their performance will be degraded by it. The complexity of health care has exploded in the last 50-plus years, as the Institute of Medicine has documented, and as described in Part I. More often than not, performance degradation has outpaced management of complexity in the financing and delivery of health care, leading to high costs and suboptimal results.

The dominant values of people working inside the system – physicians, hospital administrators, and others – emphasize independence, individualism, competition, and profits. These values are deeply rooted in US healthcare, as they are in our society more generally. This is the American Way, where relatively little attention is paid to teamwork or a sense of the common good. Our health care is uniquely expensive and ineffective compared to other developed (and even not so developed) countries where they manage medical care as a public resource, like roads, and police, and fire departments.

To examine prescribing practices in the use of biologic and nonbiologic disease-modifying antirheumatic drugs (DMARDs) to treat patients with rheumatoid arthritis (RA), before and after publication of the American College of Rheumatology (ACR) treatment recommendations.Biologics-naive RA patients under the care of a rheumatologist in the US were identified from the Consortium of Rheumatology Researchers of North America registry. Patients were included if their visits occurred prior to and/or at least 6 months after publication of the ACR treatment recommendations (time periods of February 2002-June 2008 versus December 2008-December 2009). The population was divided into 2 mutually exclusive cohorts: 1) methotrexate (MTX) monotherapy users, and 2) multiple nonbiologic DMARD users. Initiation or dose escalation of biologic and nonbiologic DMARDs in response to active disease was assessed cross-sectionally and longitudinally in comparison to the ACR recommendations. The impact of the publication of the ACR recommendations on treatment practices was assessed using logistic regression, stratified by disease activity and adjusted for clustering of physicians and geographic region.After 1 visit, 24-37% of patients receiving MTX monotherapy who had moderate disease activity and a poor prognosis or high disease activity received care consistent with the ACR recommendations; after 2 visits, 34-56% of the MTX monotherapy group received care consistent with the recommendations. In the patients receiving multiple nonbiologic DMARDs, 31-47% of those with moderate or high disease activity received care consistent with the recommendations after 1 visit, and 43-51% received such care after 2 visits. Publication of the recommendations did not significantly change treatment patterns for those with active disease.Substantial numbers of RA patients with active disease did not receive care consistent with the current ACR treatment recommendations. Innovative approaches to improve care are necessary.

This article reports the outcomes of 654 consecutive patients treated during a 4.5-year period. Patients had a microdiscectomy, a laminectomy plus microdiscectomy, or a decompressive laminectomy with a microdiscectomy. The causes of ruptured discs were lifting (31.4%), falls (10.2%), and sports (10.0%). Almost all patients had complained of leg pain (99%), and 79% had radicular pain in a dermatomal distribution. Thirty-three percent of the patients had been involved in industrial accidents, and 6% had legal claims pending during the surgical period. Almost 11% of the patients had complications, and there was one death caused by abdominal arterial bleeding. Patients were also rated according to the Prolo Functional-Economic Outcome Rating Scale to improve the ability to compare series in the future. Almost 80% of the patients had good outcomes as defined by scores on this scale of 8 (16.2%), 9 (33.2%), and 10 (26.9%). Several conclusions can be drawn from the results of this series: 1) most patients had good outcomes; 2) patients with nonindustrial injuries had better outcomes than did patients with industrial injuries; 3) professionals with legal concerns and laborers with industrial insurance had good outcomes; and 4) the Functional-Economic Outcome Rating Scale appears to be a useful tool for comparing different procedures more objectively and for comparing the outcomes across series.