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PURPOSE: The Myelopathy Disability Index and the Neck Disability Index are widely used to assess outcome in cervical spine surgery. Short Form (SF) 36 is a generic measure of health which can be used to measure health gains across a wide variety of conditions. The aim of the current study is to assess long-term outcomes using these measures in a cohort of patients with cervical spondylotic myelopathy (CSM). METHODS: Cohort study with prospective data collection. Patients with CSM being offered decompressive surgery were asked to complete a set of generic and condition-specific outcome measures. This was repeated post-operatively at 3, 12, 24 and 60 months. SF-36 was used as a generic outcome measure and the Myelopathy Index, Neck Disability Score and visual analogue scores for arm, neck and hand pain, paraesthesia and dysthaesia were used as condition-specific outcome measures. RESULTS: Significant improvements in all outcome measures were seen in 70% of the cohort. For SF-36, pre-operative scores were lower than age-matched controls in all domains and significant improvements were seen 3 months following surgery. This improvement in outcome was maintained at 5 years follow-up in approximately two-thirds of those with initial improvement. CONCLUSION: We have used generic and condition-specific outcome measures of health and shown that in patients with CSM treated surgically, up to 70% can expect improvement in their quality of life. These outcome measures are easy to collect and provide objective evidence of changes in quality of life and disability and can help quantify the potential health gains that can be achieved.

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OBJECTIVE: To assess the outcome in patients with syrinx and non-syrinx associated Chiari malformations undergoing Foramen Magnum Decompression (FMD). METHODS: Sixty-one patients undergoing FMD for Chiari malformations were prospectively studied with disease specific, generic (SF 36) and subjective (patient reported) outcomes. Of these, 34 patients had objective outcome data including SF36, visual analogue pain scores, Neck and Myelopathy disability indices and the Hospital anxiety and depression score. SF 36 scores were compared to normative data. Data were collected pre-operatively, at 3 months and during long-term follow up (12-60 months). RESULTS: Patient reported improvements in headache and neck pain post-operatively was reported in both syrinx and non-syrinx associated patients. Visual Analogue scores showed improvements in arm pain, paresthesia and hand tingling at 3 months in the syrinx group only. Non-syrinx patients showed significant improvements post-operatively in the Neck disability index and the SF-36 domains for physical function, role physical and bodily pain. Comparison with SF-36 normative data indicates that patients still have significantly impaired quality of life 12 months post-operatively. CONCLUSION: FMD is able to relieve symptoms and improve quality of life in patients with both syrinx and non-syrinx associated Chiari malformations. In syrinx patients we observed symptomatic improvement in limb symptoms as well as radiological resolution of the syrinx. The use of SF-36 allows the health gain associated with FMD to be quantified. SF 36 is not adequate as a stand alone measure of outcome in this complex disorder and we advocate the concurrent use of disease specific measures and post-operative imaging of the syrinx.

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BACKGROUND: Brain tumours account for <2% of all primary neoplasms but are responsible for 7% of the years of life lost from cancer before age 70 years. The latest survival trends for patients with CNS malignancies have remained largely static. The objective of this study was to evaluate the change in practice as a result of implementing the Improving Outcomes Guidance from the UK National Institute for Health and Clinical Excellence (NICE). METHODS: Patients were identified from the local cancer registry and hospital databases. We compared time from diagnosis to treatment, proportion of patients discussed at multidisciplinary team (MDT) meetings, treatment received, length of inpatient stay and survival. Inpatient and imaging costs were also estimated. RESULTS: Service reconfiguration and implementation of NICE guidance resulted in significantly more patients being discussed by the MDT--increased from 66 to 87%, reduced emergency admission in favour of elective surgery, reduced median hospital stay from 8 to 4.5 days, increased use of post-operative MRI from 17 to 91% facilitating early discharge and treatment planning, and reduced cost of inpatient stay from £2096 in 2006 to £1316 in 2009. Patients treated with optimal surgery followed by radiotherapy with concomitant and adjuvant temozolomide achieved outcomes comparable to those reported in clinical trials: median overall survival 18 months (2-year survival 35%). CONCLUSIONS: Advancing the management of neuro-oncology patients by moving from an emergency-based system of patient referral and management to a more planned elective outpatient-based pattern of care improves patient experience and has the potential to deliver better outcomes and research opportunities.

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We describe a technique for accurate localisation of the biopsy-site following image-guided biopsy of an intracranial lesion. The injection of 0.1 ml of air through the biopsy needle, allows the exact location of the biopsy to be visualised on post-operative CT scans performed within 24 hours of the procedure. Knowledge of the location of the biopsy can be useful in resolving ambiguous histological findings and the possibility of sampling error. Injection of 0.1 ml air is a safe and effective method for verifying the location of intracranial biopsies and is recommended as a routine part of image-guided biopsy procedures.

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Establishing standardized methods to assess outcome is needed to measure the effectiveness of surgery in relieving symptoms and improving quality of life. We prospectively studied 203 patients undergoing primary lumbar discectomy. Data was collected before surgery, at 3 months postoperatively and at long-term follow-up (12-60 months, median 24) using both disease-specific (visual analogue scores, Roland-Morris disability scales, and Hospital Anxiety and Depression scales) and generic (SF-36) instruments. Continued significant symptomatic benefit was observed to long-term assessment and the health gains in this patient group compared favourably with other elective surgical procedures. We have used this data to validate the SF-36 for use in this context and we recommend that SF36 should be used as a sole measure of outcome in routine practice, as well as in future studies.

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A multicenter, randomized, open-label, parallel-group study was conducted to compare the safety and efficacy of perioperative recombinant human erythropoietin (Epoetin alfa) with the safety and efficacy of preoperative autologous donation (PAD) in total joint arthroplasty. A total of 490 patients scheduled for total joint (i.e., hip or knee) surgery and having hemoglobin (Hb) levels > or = 11 to < or = 13 g/dL were randomized to receive weekly doses of subcutaneous Epoetin alfa on preoperative Days -21, -14, and -7, and on the day of surgery, or to participate in a PAD program. The mean baseline Hb level in both groups was 12.3+/-0.6 g/dL, increasing to 13.8 g/dL in the Epoetin alfa-treated group and decreasing to 11.1 g/dL in the PAD group before or on the day of surgery. In the PAD group, 156/219 (71.2%) patients were transfused with autologous blood, and 42/219 (19.2%) patients were transfused with allogeneic blood. A smaller proportion, 27/209 (12.9%) patients, in the Epoetin alfa-treated group were transfused with allogeneic blood (P = .078 compared with the PAD group). Moreover, patients in the PAD group received a total of 325 units of blood (79 allogeneic units and 246 autologous units) compared with patients in the Epoetin alfa group who received a total of 54 units of blood. The mean postoperative Hb level was 11.0 g/dL in the Epoetin alfa-treated group and 9.2 g/dL in the PAD group. Compared with the PAD arm, mean Hb levels measured preoperatively, postoperatively on Day 1, and at discharge visits were significantly greater in the Epoetin alfa-treated arm (P < .0001 ).

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Data from four prospective, multicenter, randomized studies involving 869 major, elective orthopedic surgery patients were examined by means of a retrospective integrated analysis to evaluate whether perioperative Epoetin alfa use was associated with the occurrence of thrombotic/vascular events. The incidence of thrombotic/vascular events was similar between 619 patients treated with Epoetin alfa and 250 patients receiving placebo (7.4% versus 8.0%, respectively). Regression analyses identified age, cardiac history, hypertension, and cardiac medications, but not Epoetin alfa, as risk factors for thrombotic/vascular events. The analysis did not implicate an increase in the rate of rise in hematocrit or maximum hematocrit obtained prior to surgery as contributors to thrombotic events. Thus, Epoetin alfa, which enhances preoperative erythropoiesis and increases hematocrit, did not affect the probability of thrombotic/vascular events.

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Over a 10-yr. period 11.6% of the 3738 patients referred to a general hospital's psychological clinic in South Africa did not attend their first appointments. Patients who had engaged in suicidal behaviours and those with somatoform symptoms were the predominant nonattenders, while those with depressive symptoms had the lowest nonattendance rate.

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OBJECTIVES: To understand the pharmacokinetic and pharmacodynamic properties of recombinant human erythropoietin (epoetin alfa) and to continue to optimize dosing regimens by determining whether administration of single high doses of epoetin alfa is as effective as repeated administration. METHODS: Epoetin alfa was administered as single subcutaneous doses of 300, 450, 600, 900, 1200, 1350, 1800, and 2400 IU/kg and in multiple subcutaneous dose regimens: 150 IU/kg 3 times a week for 4 weeks and 600 IU/kg once per week for 4 weeks in 2 open-label, randomized placebo-controlled studies in healthy volunteers. RESULTS: The absorption rate of epoetin alfa after subcutaneous administration was independent of dose, whereas clearance was dose-dependent in that it decreased with increasing dose. There was a linear relationship between response measured as percentage of reticulocytes area under the curve (AUC) and erythropoietin AUC for single doses up to 1800 IU/kg. Beyond the 1800 IU/kg dose, there was a saturation of response. The mean percentage of reticulocytes after single-dose regimens began to increase by days 3 to 4, reached their maximum at days 8 to 11, and returned to baseline values by day 22. In contrast, the mean percentage of reticulocytes after both multiple-dose regimens were maintained above baseline values through day 22 as both regimens stimulated modest but sustained increases in percentage of reticulocytes (1% to 2%). The mean percentage of reticulocytes AUC for 600 IU/kg epoetin alfa given once a week for 4 weeks was apparently greater than the mean percentage of reticulocytes AUC for 150 IU/kg 3 times a week for 4 weeks. Although daily oral iron supplementation was given, mean serum ferritin levels declined by approximately 75% through day 22 in subjects treated with multiple doses of epoetin alfa. CONCLUSIONS: These findings show that the pharmacologic response to epoetin alfa is a function of dose and dosing regimen. Repeated administration of epoetin alfa was more effective in stimulating a reticulocyte response than single-dose administration of the same total amount of epoetin alfa.

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BACKGROUND: This article describes the development and psychometric evaluation of the Pulmonary Functional Status Scale (PFSS). The PFSS was developed to address the need for a self-administered, disease-specific, functional status outcome measure that was conceptually based, relatively short, and comprehensively assessed the psychosocial domains affected by chronic pulmonary disease. METHODS: Content validity of the PFSS was established by a panel of experts. Construct validity was determined by principal components factor analysis using data from 365 subjects derived from several studies that used the PFSS. The sample was predominantly white (80%), married (36%), and male (56%) with a mean age of 68.1 years, mean forced expiratory volume in one second of 1.18 L and mean forced vital capacity of 2.31 L. Test-retest reliability was evaluated in 17 outpatients with chronic obstructive pulmonary disease. Concurrent validity was assessed by correlating responses on the total PFSS with the Sickness Impact Profile (SIP) score (n = 39), and the 12-minute walk test (n = 104). RESULTS: The factor structure solution used 35 of the 50 submitted items, explained 48.7% of the variance, and yielded three factors: Daily Activities/Social Functioning, Psychological Functioning, and Sexual Functioning. Cronbach's alpha coefficients for the total PFSS was 0.93 and the test-retest correlation coefficient was rho = 0.75 (P = 0.001). The correlation between the total PFSS score and the SIP and 12-minute walk test were r = -0.54 (P < 0.001) and r = 0.62 (P < 0.001), respectively. CONCLUSION: The PFSS has solid psychometric properties that make it acceptable for use in clinical practice as well as research.

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BACKGROUND: Patients having a cardiac operation frequently require allogeneic blood transfusions despite surgical blood-conservation techniques. Recombinant human erythropoietin (Epoetin alfa) may augment this conservation by stimulating erythropoiesis. The safety and efficacy of perioperative use of Epoetin alfa to reduce the need of allogeneic transfusion was studied. METHODS: A multicenter double-blind, placebo-controlled, parallel-group study involved 182 patients having coronary artery bypass grafting and randomized to receive Epoetin alfa (300 or 150 IU/kg) or placebo subcutaneously for 5 days before, on the day of, and for 2 days after operation. RESULTS: Perioperative Epoetin alfa resulted in greater increases in baseline to preoperative hemoglobin levels and hematocrit (300 IU/kg) and in presurgery to postsurgical day 1 reticulocyte counts versus placebo (p < or = 0.05). However, there was no significant difference in transfusion requirements. Incidences of adverse events were similar in all study groups. CONCLUSIONS: Lower incidences of allogeneic blood exposure were observed in both Epoetin alfa-treated groups; however, the differences between all treatment groups were not significant. This was probably due to the relatively short 5-day preoperative course of Epoetin alfa therapy. There were no significant differences between the three groups relative to safety. Epoetin alfa was well tolerated in this population.

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A multicenter, double-blind, placebo-controlled, parallel-group study was undertaken to determine whether Epoetin alfa can reduce perioperative transfusion requirements. Twenty-six medical centers enrolled 316 patients who were scheduled for major orthopedic surgery and were expected to require > or = 2 units of blood. Patients were stratified according to baseline hemoglobin levels and randomly assigned to receive either Epoetin alfa (300 IU/kg or 100 IU/kg) or placebo for 15 consecutive days starting 10 days prior to, on the day of, and for 4 days after surgery. Epoetin alfa (300 IU/kg) resulted in significantly less exposure to allogeneic blood transfusion compared with placebo (16%) versus 45%) in patients whose baseline hemoglobin level was > 10 to < or = 13 g/dL (P = 0.024). Mean number of units transfused per patient was also lower among those treated with Epoetin alfa (overall, P = 0.027). Epoetin alfa was safe and well tolerated in this population.

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Previous studies have demonstrated the efficacy of perioperative Epoetin alfa in decreasing allogeneic transfusion exposure in patients undergoing orthopedic surgery. A randomized, multicenter trial was conducted comparing the safety and efficacy of a weekly Epoetin alfa dosing regimen in patients with hemoglobin levels > or = 10 to < or = 13 g/dL scheduled to undergo major elective orthopedic arthroplasty, with a daily regimen previously shown to be effective. patients on the weekly regimen showed a greater baseline-to-presurgery hemoglobin increase versus the daily regimen group (1.44 +/- 1.029 g/dL versus 0.73 +/- 0.867 g/dL). Moreover, the weekly 600 IU/kg regimen was similar to the daily 300 IU/kg regimen with respect to safety and the avoidance of allogeneic transfusion. These data showed the weekly Epoetin alfa regimen to be at least as efficacious as the daily regimen and more convenient.

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The number of Medicare-certified home health agencies nearly doubled from 1980 to 1990. Using Health Care Financing Administration data, this study documented national and regional patterns of entry and exist by Medicare home health providers from 1980 to 1990. Nationally, agency origination rates accelerated during the early 1980s and then dropped abruptly in the second half of the decade. The proprietary sector, accounting for approximately 42% of agencies in existence during the period of the study, exhibited the greatest volatility. Regional differences are also evident. Both expansion and contraction in Medicare home health services appear to be a response to the incentives of legislation implemented during this period.

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Using Health Care Financing Administration (HCFA) data, this study documents national and regional patterns of market entry and exit in the home health industry from 1980 to 1990. Nationally, agency origination rates accelerated during the early 1980's, then dropped abruptly in the second half of the decade. The for-profit sector exhibited the greatest volatility. Of the 3,620 proprietary agencies in existence during the decade, 3,284 (90.7%) were new entrants, and 1,551 exited the market by 1990. Regional differences in growth rates and the timing of market entry are also evident. Both growth and decline in the home health industry appear to be a response to the incentives of legislation implemented during this period.

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