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This paper presents preliminary quality and utilization data from a hospitalist system that is being implemented at Kaiser Permanente, a large health maintenance organization with 16 hospitals in northern California. Hospitalist programs, which are staffed by clinicians highly skilled in caring for inpatients, are being launched with the aim of delivering high-quality, efficient medical care in an increasingly competitive health care delivery environment. This paper also describes, in some detail, the process of implementation at one hospital. Challenges to implementation included 1) overcoming the reluctance of clinic physicians to relinquish inpatient care responsibilities, 2) developing sustainable work schedules, 3) creating effective channels of communication between staff in inpatient and outpatient settings, and 4) designing appropriate compensation scales for hospitalists. Mean length of stay, patient-day rates, admission rates, consultation request rates, costs, and readmission rates were examined for patients discharged from adult medicine services at all 16 hospitals between 1 January 1994 and 30 June 1997. These preliminary resource utilization data seem promising, but further analysis is needed to assess how hospitalist programs may affect clinical quality of care, costs, and patient and provider satisfaction. [ABSTRACT FROM AUTHOR]

This study examines the course of patient-reported side effects during the first 4 months of treatment for multiple sclerosis (MS) with interferon beta-1a (IFNβ-1a), and the relationship of those side effects to discontinuation of medication. Flu-like symptoms, muscle aches and chills decreased over the first 2 months of treatment but did not change over the second 2 months. Loss of feeling or numbness, tingling and depression increased over 4 months, however these side effects were generally mild. Loss of feeling or numbness and tingling at 2 month follow-up were significantly related to discontinuation of IFNβ-1a by 4 month follow-up. [ABSTRACT FROM AUTHOR]

Background: Ischemic stroke has no approved treatments to enhance recovery. ALD-401 is an enriched population of aldehyde dehydrogenase-bright stem cells, capable of reducing neurological deficits in animal models. The primary objective of this trial was to determine the safety of internal carotid artery, intra-arterially delivered autologous bone marrow-derived ALD-401 in patients with disabling middle cerebral artery stroke in comparison with sham harvest with sham infusion. Secondary objectives were to determine feasibility and efficacy., Methods: This was a prospective phase 2, industry-funded, randomized, sham-controlled, parallel-group, multicenter study with blinded assessments. One hundred subjects were planned, aged 30 to 83 years, with confirmed first-time middle cerebral artery ischemic stroke with modified Rankin scale ≥3. Study patients were randomly assigned 3:2 to bone marrow harvest at 11 to 17 days after stroke followed 2 days later by intracarotid infusion of ALD-401 versus sham harvest and then sham infusion in the same timeframe. The primary study outcome was safety based on the incidence of a 4-point National Institutes of Health Stroke Scale worsening and the proportion of serious adverse events. Efficacy was based on modified Rankin scale change at 90 days. Other secondary outcomes were the proportions of patients experiencing adverse events, disability by Barthel Index, quality of life using EQ-5D, rehabilitation utilization, disability at 1 year, and MRI evidence of complications., Results: There were no infusional or allergic reactions and no difference in treatment emergent adverse events. Four patients had small areas of asymptomatic restricted diffusion on MRI in the treatment group. There was no significant difference between the ALD-401 and placebo groups on the modified Rankin scale for the intent-to-treat population at day 90 (mean difference, 0.3; 95% CI, -0.3 to 0.8; P=0.330). There were no significant differences between the groups on any of the secondary efficacy measures., Conclusions: Intracarotid infusion of ALD-401 does not lead to clinical adverse events in patients with subacute ischemic stroke, although there was a higher incidence of small lesions on MRI in the treatment group. There was no difference in the primary efficacy end point between the groups. The study provides a framework for the design and conduct of future intra-arterial cell therapy trials in stroke., Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01273337.

Background: Up to 30% of acute stroke evaluations are deemed stroke mimics (SM). As telestroke consultation expands across the world, increasing numbers of SM patients are likely being evaluated via Telestroke. We developed a model to prospectively identify ischemic SMs during Telestroke evaluation., Methods and Results: We analyzed 829 consecutive patients from January 2004 to April 2013 in our internal New England-based Partners TeleStroke Network for a derivation cohort, and 332 cases for internal validation. External validation was performed on 226 cases from January 2008 to August 2012 in the Partners National TeleStroke Network. A predictive score was developed using stepwise logistic regression, and its performance was assessed using receiver-operating characteristic (ROC) curve analysis. There were 23% SM in the derivation, 24% in the internal, and 22% in external validation cohorts based on final clinical diagnosis. Compared to those with ischemic cerebrovascular disease (iCVD), SM had lower mean age, fewer vascular risk factors, more frequent prior seizure, and a different profile of presenting symptoms. The TeleStroke Mimic Score (TM-Score) was based on factors independently associated with SM status including age, medical history (atrial fibrillation, hypertension, seizures), facial weakness, and National Institutes of Health Stroke Scale >14. The TM-Score performed well on ROC curve analysis (derivation cohort AUC=0.75, internal validation AUC=0.71, external validation AUC=0.77)., Conclusions: SMs differ substantially from their iCVD counterparts in their vascular risk profiles and other characteristics. Decision-support tools based on predictive models, such as our TM Score, may help clinicians consider alternate diagnosis and potentially detect SMs during complex, time-critical telestroke evaluations., (© 2014 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Background: Several case reports of the onset or exacerbation of multiple sclerosis or other demyelinating conditions shortly after vaccination have suggested that vaccines may increase the risk of demyelinating diseases., Objective: To evaluate the association between vaccination and onset of multiple sclerosis or optic neuritis., Design: Case-control study involving cases of multiple sclerosis or optic neuritis among adults 18 to 49 years of age. Data on vaccinations and other risk factors were obtained from computerized and paper medical records and from telephone interviews., Setting: Three health maintenance organizations., Participants: Four hundred forty case subjects and 950 control subjects matched on health maintenance organization, sex, and date of birth., Interventions: None., Main Outcome Measures: Onset of first symptoms of demyelinating disease at any time after vaccination and during specified intervals after vaccination (<1 year, 1-5 years, and >5 years)., Results: Cases and controls had similar vaccination histories. The odds ratios (95% confidence intervals), adjusted for potential confounding variables, of the associations between ever having been vaccinated and risk of demyelinating disease (multiple sclerosis and optic neuritis combined) were 0.9 (0.6-1.5) for hepatitis B vaccine; 0.6 (0.4-0.8) for tetanus vaccination; 0.8 (0.6-1.2) for influenza vaccine; 0.8 (0.5-1.5) for measles, mumps, rubella vaccine; 0.9 (0.5-1.4) for measles vaccine; and 0.7 (0.4-1.0) for rubella vaccine. The results were similar when multiple sclerosis and optic neuritis were analyzed separately. There was no increased risk according to timing of vaccination., Conclusion: Vaccination against hepatitis B, influenza, tetanus, measles, or rubella is not associated with an increased risk of multiple sclerosis or optic neuritis.

The management of many chronic illnesses involves medications that must be injected on a frequent basis. With fewer support resources available, patients are increasingly being obliged to manage injectable medications themselves. Interferon beta-1a (IFNbeta-1a), recommended for the treatment of multiple sclerosis (MS), must be injected intramuscularly on a weekly basis. Patients are generally advised and taught to self-inject, if possible. This longitudinal study examined cognitive and affective contributions to the ability to self-inject and adherence to IFNbeta-1a over 6 months following initiation of medication. Participants were 101 patients with a relapsing form of MS. Injection self-efficacy expectations, injection anxiety, adherence expectations, method of injection administration, and 6-month adherence to IFNbeta-1a were fitted to a path analytic model. Pretreatment injection self-efficacy expectations were significantly related to 6-month adherence. This relation was mediated by the patient's ability to self-inject. Patients 'experienced level of injection anxiety was related to adherence but not to method of injection.

This study examined the efficacy of an 8-week telephone-administered cognitive-behavioral therapy (CBT) for the treatment of depressive symptomatology in multiple sclerosis (MS) patients. The treatment, Coping with MS (CMS), included a patient workbook designed to structure the treatment, provide visual aids, and help with homework assignments. Thirty-two patients with MS, who scored at least 15 on the Profile of Mood States Depression-Dejection scale, were randomly assigned to either the telephone CMS or to a usual-care control (UCC) condition. Depressive symptomatology decreased significantly in the CMS condition compared with the UCC condition. Furthermore, adherence to interferon beta-1a, a disease-modifying medication for the treatment of MS, was significantly better at the 4-month follow-up among patients who received CMS as compared with those in the UCC condition.

Objective: To examine the hypothesis that increases in depression after initiation of treatment with interferon beta-1a for multiple sclerosis can be explained as representing a return to pretreatment levels of depression., Design: Level of depression in patients with multiple sclerosis was assessed at 3 time points: 2 weeks before initiation of interferon beta-la treatment, at initiation of treatment, and at 2-month follow-up., Setting: A health maintenance organization., Patients: Fifty-six patients with confirmed relapsing forms of multiple sclerosis., Main Outcome Measure: The depression-dejection scale of the Profile of Mood States., Results: Patients who scored high on the depression measure 2 weeks before the initiation of interferon beta-1a treatment showed significant reduction in depression at the initiation of treatment. However, depression returned nearly to initial levels within 2 months., Conclusions: These findings suggest that increases in depression after initiation of interferon beta-1a treatment are related to level of depression 2 weeks before initiation of treatment. Physicians should assess history of depression for all patients in whom interferon beta-1a treatment is initiated. Patients with a recent history of depression are at risk for increased depression within 2 months after starting interferon beta-1a treatment, even though they may not be depressed at the time of treatment initiation.

This study examined subjective patient experiences of the psychosocial consequences of multiple sclerosis (MS). Fifty patients were interviewed regarding the effects MS had on their lives and interpersonal relationships. These statements were collated and administered with a 5-point Likert scale to 94 MS patients. The responses were subjected to factor analysis. Three areas of subjective patient experience of the psychosocial consequences of MS emerged: demoralization, benefit-finding, and deteriorated relationships. Of particular interest was benefit-finding, which included a deepening of relationships, enhanced appreciation of life, and an increase in spiritual interests. Although benefit-finding was related to adaptive coping strategies such as positive reappraisal and seeking social support, it was unrelated to depression and was related to higher levels of anxiety and anger. These findings indicate that benefit-finding is a substantial and poorly understood part of the illness experience for MS patients.

The percentage contribution of each item on the Beck Depression Inventory (BDI) to the total BDI score was compared across patients with multiple sclerosis (MS), patients diagnosed with major depressive disorder, and normal college students. We considered an item to be confounded by MS-related symptoms if its percentage contribution to the total BDI score was significantly greater in the MS group than the major depression and control groups. Items measuring work difficulty, fatigue, and concerns about health met this criterion. These items accounted for 34, 17, and 19% of the total BDI score in the MS, major depression, and control groups, respectively. Using the 18-item BDI (BDI-18) which resulted from excluding the 3 confounded items, MS patients found to be were more depressed than controls but less depressed than the major depression group. The identification of signs of depression not confounded with MS which could be substituted for confounded signs was also discussed.

This study, conducted in three separate outpatient health care delivery settings, examined the therapeutic expectations of patients with multiple sclerosis (MS) before they initiated interferon beta-1b therapy, the results of current educational procedures to correct unrealistic expectations, and the relationship between post-education expectations and discontinuing therapy. Ninety-nine consecutive patients were seen in a university based outpatient MS clinic, an academic group practice outpatient MS clinic, or a health maintenance organization outpatient neurology clinic. Before the educational sessions, 57% of the patients expressed unrealistically optimistic expectations regarding reduction in attack rate and 34% expressed unrealistically optimistic expectations regarding improvement in functional status. Educational procedures significantly altered unrealistic expectations but the results were sub-optimal since 33% of the patients maintained overly optimistic expectations regarding reduction in attack rate. Post-education unrealistic expectations of improvement in functional status were significantly related to discontinuing therapy within 6 months. Three adverse effects of therapy also were related independently to adherence to treatment: depression and flu-like symptoms were related to discontinuing therapy while soreness at injection site was related to continuing therapy.

Epidemiological, clinical, and CSF data were collected on 87 patients with clinically definite multiple sclerosis (MS) and 50 with probable MS. As part of a study of immunologic reactivity to viral antigens, a control group separated into 26 patients with probable inflammatory neural disease and 140 with noninflammatory neural disease was similarly studied. Among the groups with MS, females predominated and both Oriental and Spanish surnamed patients were under-represented. The spinal cord, optic nerves, and brainstem were the most common sites of initial disease and more than 20% of the patients had only cord symptoms after several years of disease activity. Of several CSF assays used, determination of oligoclonal IgG bands by agarose electrophoresis was most useful diagnostically.

The CSF from 279 patients with multiple sclerosis (MS), probable MS, or controls was examined by radioimmunoassay (RIA) for antibodies to measles, rubella, mumps, parainfluenza 1 (Sendai) (strain 6/94), herpes simplex (HSV), varicella, and vaccinia viruses. Significantly more patients with MS than noninflammatory control patients had antibody to measles, rubella and varicella viruses, of which antibody to measles was the most prevalent. The percentage of patients with MS with two or more CSF antibodies was significantly greater than that in the controls. There was no tendency for certain antibodies to be associated. There was a general relationship between presence of CSF antibodies and severity of MS. The data support the hypothesis of local CNS antibody synthesis of several viral antibodies; however, such local synthesis may be a random event, possibly dependent on the number and specificity of peripheral virus antibody-forming lymphocytes available for ingress into the CNS.

Sera and CSFs of 85 patients with multiple sclerosis (MS), 49 patients with probable MS, and 165 control patients with other neurologic diseases were assayed for antibodies to rubella, mumps, measles, parainfluenza I (strain 6/94), herpes simplex, cytomegalovirus, varicella-zoster, and vaccinia viruses. Methods included complement fixation (CF), hemagglutination inhibition (HI), and complement-dependent plaque reduction (CPR). Significant differences between the groups with MS and the control groups were higher serum antibody titers to measles virus in the groups with MS, higher proportion of patients with MS with CSF antibodies to measles, rubella, and vaccinia viruses, and greater percentage of patients with MS with more than one CSF viral antibody. Duration and severity of disease in the patients with MS were associated with presence of multiple CSF antibodies. Presence of CSF antibody was positively correlated with the height of the correspnding serum titer, yet a high serum titer did not ensure the presence of CSF antibody. Oligoclonal bands were present in the CSFs of equal proportions of patients with MS with and without CSF viral antibody. Our data support the hypothesis of local antibody synthesis within the CNS. However, we favor the view that preprogrammed antibody-forming lymphocytes enter the CNS and then produce antibody either because of nonspecific polyclonal activation in situ or because of failure of normal regulation.

The EP is well demonstrated as a useful indicator of subclinical demyelinating disease. Our study performed on patients well defined as MS and monitored closely for clinical exacerbations demonstrated an unexpectedly high occurrence of significant worsening in EP parameters. These changes occurred in the presence or absence of clinical worsening. The parameter changes may represent new demyelination or other pathologic or neurophysiologic changes in neuropathologically static lesions.

Neurologists in the Kaiser-Permanente Medical Care Program recently designed a study to evaluate the utility of intensive immunosuppression with cyclophosphamide compared with folic acid in 44 patients with chronic progressive multiple sclerosis (MS). Although preliminary results based on incomplete data suggest cyclophosphamide may be safely administered in an outpatient clinic setting and modest benefits cannot be ruled out, it is doubtful that there are very substantial benefits to that therapy. Although several other studies have been cited as evidence of cyclophosphamide's favorable effect on the clinical course of patients with MS, many of these studies have had design shortcomings. If these flaws are considered, the hypothesis that cyclophosphamide has a favorable effect on the course of MS must be considered weak.