Centralising and optimising decentralised stroke care systems: a simulation study on short-term costs and effects.

BACKGROUND: Centralisation of thrombolysis may offer substantial benefits. The aim of this study was to assess short term costs and effects of centralisation of thrombolysis and optimised care in a decentralised system. METHODS: Using simulation modelling, three scenarios to improve decentralised settings in the North of Netherlands were compared from the perspective of the policy maker and compared to current decentralised care: (1) improving stroke care at nine separate hospitals, (2) centralising and improving thrombolysis treatment to four, and (3) two hospitals. Outcomes were annual mean and incremental costs per patient up to the treatment with thrombolysis, incremental cost-effectiveness ratio (iCER) per 1% increase in thrombolysis rate, and the proportion treated with thrombolysis. RESULTS: Compared to current decentralised care, improving stroke care at individual community hospitals led to mean annual costs per patient of $US 1,834 (95% CI, 1,823-1,843) whereas centralising to four and two hospitals led to $US 1,462 (95% CI, 1,451-1,473) and $US 1,317 (95% CI, 1,306-1,328), respectively (P < 0.001). The iCER of improving community hospitals was $US 113 (95% CI, 91-150) and $US 71 (95% CI, 59-94), $US 56 (95% CI, 44-74) when centralising to four and two hospitals, respectively. Thrombolysis rates decreased from 22.4 to 21.8% and 21.2% (P = 0.120 and P = 0.001) in case of increasing centralisation. CONCLUSIONS: Centralising thrombolysis substantially lowers mean annual costs per patient compared to raising stroke care at community hospitals simultaneously. Small, but negative effects on thrombolysis rates may be expected.

Can Patients With Low Back Pain Be Satisfied With Less Than Expected?

STUDY DESIGN: A prospective cohort study within care as usual. OBJECTIVE: (1) To explore the psychometric properties of a baseline disability questionnaire designed to collect patients' expectation. (2) To analyze relations between satisfaction with care and treatment success in patients with chronic low back pain (CLBP). (3) To determine the chances of being satisfied with the received care in absence of treatment success. SUMMARY OF BACKGROUND DATA: There is a lack of evidence on determinants of treatment satisfaction in patients with CLBP, specifically the role of patient's expectation of disability reduction after treatment. METHODS: Treatment expectation was measured with questions inspired by the Pain Disability Index (PDI) at baseline. Treatment success was considered if disability at the end of therapy was lower than, or equal to pretreatment expectation. An exploratory factor analysis was performed on the new questionnaire. Binary logistic regression models were used to analyze how much variance of satisfaction with care was explained by treatment success, pain disability at baseline, sex, age, duration of complaints, and pain intensity. The odds ratio of being satisfied when treatment was successful was calculated. RESULTS: Six hundred nine patients were included. The factor structure of the PDI-expectancy had optimal fit with a one factor structure. There were low correlations between the expected and baseline disability, pain intensity, and duration of pain. Correlation between treatment success and satisfaction with care was low (χ = 0.13; P < 0.01). Treatment success had a low contribution to satisfaction with care. Of all participating patients, 51.4% were satisfied with care even when treatment was not successful. The odds ratio for being satisfied was 2.42 when treatment was successful compared to when treatment was not successful. CONCLUSION: The PDI-expectancy is internally consistent. Pretreatment expectation contributes uniquely but slightly to satisfaction with care; patients whose treatment was considered successful have 1.38 to 4.24 times higher chance of being satisfied at the end of treatment. Even when treatment was not successful, 51.4% of the patients with CLBP are satisfied with care. LEVEL OF EVIDENCE: 2.

Time to Reperfusion and Treatment Effect for Acute Ischemic Stroke: A Randomized Clinical Trial.

IMPORTANCE: Intra-arterial treatment (IAT) for acute ischemic stroke caused by intracranial arterial occlusion leads to improved functional outcome in patients treated within 6 hours after onset. The influence of treatment delay on treatment effect is not yet known. OBJECTIVE: To evaluate the influence of time from stroke onset to the start of treatment and from stroke onset to reperfusion on the effect of IAT. DESIGN, SETTING, AND PARTICIPANTS: The Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands (MR CLEAN) was a multicenter, randomized clinical open-label trial of IAT vs no IAT in 500 patients. The time to the start of treatment was defined as the time from onset of symptoms to groin puncture (TOG). The time from onset of treatment to reperfusion (TOR) was defined as the time to reopening the vessel occlusion or the end of the procedure in cases for which reperfusion was not achieved. Data were collected from December 3, 2010, to June 3, 2014, and analyzed (intention to treat) from July 1, 2014, to September 19, 2015. MAIN OUTCOMES AND MEASURES: Main outcome was the modified Rankin Scale (mRS) score for functional outcome (range, 0 [no symptoms] to 6 [death]). Multiple ordinal logistic regression analysis estimated the effect of treatment and tested for the interaction of time to randomization, TOG, and TOR with treatment. The effect of treatment as a risk difference on reaching independence (mRS score, 0-2) was computed as a function of TOG and TOR. Calculations were adjusted for age, National Institutes of Health Stroke Scale score, previous stroke, atrial fibrillation, diabetes mellitus, and intracranial arterial terminus occlusion. RESULTS: Among 500 patients (58% male; median age, 67 years), the median TOG was 260 (interquartile range [IQR], 210-311) minutes; median TOR, 340 (IQR, 274-395) minutes. An interaction between TOR and treatment (P = .04) existed, but not between TOG and treatment (P = .26). The adjusted risk difference (95% CI) was 25.9% (8.3%-44.4%) when reperfusion was reached at 3 hours, 18.8% (6.6%-32.6%) at 4 hours, and 6.7% (0.4%-14.5%) at 6 hours. CONCLUSION AND RELEVANCE: For every hour of reperfusion delay, the initially large benefit of IAT decreases; the absolute risk difference for a good outcome is reduced by 6% per hour of delay. Patients with acute ischemic stroke require immediate diagnostic workup and IAT in case of intracranial arterial vessel occlusion. TRIAL REGISTRATION: trialregister.nl Identifier: NTR1804.

Reference Values of the Pain Disability Index in Patients With Painful Musculoskeletal and Spinal Disorders: A Cross-national Study.

STUDY DESIGN: Cross-sectional study. OBJECTIVE: To examine reference data for the Pain Disability Index (PDI) in Dutch and Canadian patient samples with a variety of musculoskeletal pain disorders and to test which potential factors are independently associated with the PDI score. SUMMARY OF BACKGROUND DATA: The PDI is a widely used generic instrument for measuring disability related to pain. It is unknown whether patients with spinal and other musculoskeletal diagnoses have different levels of disability when scored on the PDI. METHODS: Patients were referred to secondary and tertiary care centers in the Netherlands and Alberta, Canada, between 2009 and 2013. All patients filled out a baseline questionnaire including demographics and the PDI. After first consultation with a medical doctor, diagnoses were set by the medical specialist. Univariate general linear models were used to examine correlations between PDI scores and age, sex, country of residence, diagnosis, and work status. RESULTS: In total 6997 patients were included in this study: 1302 Canadian and 5695 Dutch patients. Mean PDI score of the total group was 37.8 ± 14.2. Reference values are presented and clustered into the following diagnostic groups: spinal nerve and intervertebral disc disorders; nonspecific back pain; rheumatic soft-tissue pain (widespread pain or fibromyalgia); spinal stenosis; and whiplash-associated disorder. The PDI score was significantly and relevantly associated with pain intensity (η explained variance from 20% to 25%), but not relevantly associated with age, sex, country of residence, and diagnostic group (η<3%). In the working subgroup, adding "current sick leave" as covariate increased the explained variance to 34%. CONCLUSION: Reference values of the PDI are presented. Patient ratings of disability on the PDI are relevantly associated with pain intensity and work status, but not with nationality or diagnostic group. Only minimal differences were identified between the various musculoskeletal diagnoses included. LEVEL OF EVIDENCE: N/A.

A randomized trial of intraarterial treatment for acute ischemic stroke.

BACKGROUND: In patients with acute ischemic stroke caused by a proximal intracranial arterial occlusion, intraarterial treatment is highly effective for emergency revascularization. However, proof of a beneficial effect on functional outcome is lacking. METHODS: We randomly assigned eligible patients to either intraarterial treatment plus usual care or usual care alone. Eligible patients had a proximal arterial occlusion in the anterior cerebral circulation that was confirmed on vessel imaging and that could be treated intraarterially within 6 hours after symptom onset. The primary outcome was the modified Rankin scale score at 90 days; this categorical scale measures functional outcome, with scores ranging from 0 (no symptoms) to 6 (death). The treatment effect was estimated with ordinal logistic regression as a common odds ratio, adjusted for prespecified prognostic factors. The adjusted common odds ratio measured the likelihood that intraarterial treatment would lead to lower modified Rankin scores, as compared with usual care alone (shift analysis). RESULTS: We enrolled 500 patients at 16 medical centers in The Netherlands (233 assigned to intraarterial treatment and 267 to usual care alone). The mean age was 65 years (range, 23 to 96), and 445 patients (89.0%) were treated with intravenous alteplase before randomization. Retrievable stents were used in 190 of the 233 patients (81.5%) assigned to intraarterial treatment. The adjusted common odds ratio was 1.67 (95% confidence interval [CI], 1.21 to 2.30). There was an absolute difference of 13.5 percentage points (95% CI, 5.9 to 21.2) in the rate of functional independence (modified Rankin score, 0 to 2) in favor of the intervention (32.6% vs. 19.1%). There were no significant differences in mortality or the occurrence of symptomatic intracerebral hemorrhage. CONCLUSIONS: In patients with acute ischemic stroke caused by a proximal intracranial occlusion of the anterior circulation, intraarterial treatment administered within 6 hours after stroke onset was effective and safe. (Funded by the Dutch Heart Foundation and others; MR CLEAN Netherlands Trial Registry number, NTR1804, and Current Controlled Trials number, ISRCTN10888758.).

Prehospital factors determining regional variation in thrombolytic therapy in acute ischemic stroke.

BACKGROUND: Treatment rates with intravenous tissue plasminogen activator vary by region, which can be partially explained by organizational models of stroke care. A recent study demonstrated that prehospital factors determine a higher thrombolysis rate in a centralized vs. decentralized model in the north of the Netherlands. AIM: To investigate prehospital factors that may explain variation in thrombolytic therapy between a centralized and a decentralized model. METHODS: A consecutive case observational study was conducted in the north of the Netherlands comparing patients arriving within 4·5 h in a centralized vs. decentralized stroke care model. Factors investigated were transportation mode, prehospital diagnostic accuracy, and preferential referral of thrombolysis candidates. Potential confounders were adjusted using logistic regression analysis. RESULTS: A total of 172 and 299 arriving within 4·5 h were enrolled in centralized and decentralized settings, respectively. The rate of transportation by emergency medical services was greater in the centralized model (adjusted odds ratio 3·11; 95% confidence interval, 1·59-6·06). Also, more misdiagnoses of stroke occurred in the central model (P = 0·05). In postal code areas with and without potential preferential referral of thrombolysis candidates due to overlapping catchment areas, the odds of hospital arrival within 4·5 h in the central vs. decentral model were 2·15 (95% confidence interval, 1·39-3·32) and 1·44 (95% confidence interval, 1·04-2·00), respectively. CONCLUSIONS: These results suggest that the larger proportion of patients arriving within 4·5 h in the centralized model might be related to a lower threshold to use emergency services to transport stroke patients and partly to preferential referral of thrombolysis candidates.

Thrombolysis in acute ischemic stroke: a simulation study to improve pre- and in-hospital delays in community hospitals.

BACKGROUND: Various studies demonstrate better patient outcome and higher thrombolysis rates achieved by centralized stroke care compared to decentralized care, i.e. community hospitals. It remains largely unclear how to improve thrombolysis rate in decentralized care. The aim of this simulation study was to assess the impact of previously identified success factors in a central model on thrombolysis rates and patient outcome when implemented for a decentral model. METHODS: Based on a prospectively collected dataset of 1084 ischemic stroke patients, simulation was used to replicate current practice and estimate the effect of re-organizing decentralized stroke care to resemble a centralized model. Factors simulated included symptom onset call to help, emergency medical services transportation, and in-hospital diagnostic workup delays. Primary outcome was proportion of patients treated with thrombolysis; secondary endpoints were good functional outcome at 90 days, Onset-Treatment-Time (OTT), and OTT intervals, respectively. RESULTS: Combining all factors might increase thrombolysis rate by 7.9%, of which 6.6% ascribed to pre-hospital and 1.3% to in-hospital factors. Good functional outcome increased by 11.4%, 8.7% ascribed to pre-hospital and 2.7% to in-hospital factors. The OTT decreased 17 minutes, 7 minutes ascribed to pre-hospital and 10 minutes to in-hospital factors. An increase was observed in the proportion thrombolyzed within 1.5 hours; increasing by 14.1%, of which 5.6% ascribed to pre-hospital and 8.5% to in-hospital factors. CONCLUSIONS: Simulation technique may target opportunities for improving thrombolysis rates in acute stroke. Pre-hospital factors proved to be the most promising for improving thrombolysis rates in an implementation study.

A simulation-based approach for improving utilization of thrombolysis in acute brain infarction.

BACKGROUND: Treatment with tissue plasminogen activator (tPA) is the most effective treatment in acute brain infarction. However, estimated worldwide treatment rates are <10%, with many barriers hampering broad implementation. Organization and resource-intense randomized controlled trials cannot address all potential barriers simultaneously. Simulation, however, may provide an efficient research means for testing interventions aimed at resolving barriers along the care pathway. RESEARCH DESIGN: A simulation-based approach reflecting the setup of a regional Dutch acute stroke pathway was used. First, barriers along the overall pathway were identified. Next, solutions to barriers were configured, and subsequently tested using simulation. RESULTS: Barriers along the stroke pathway and possible solutions were identified from the literature and expert consultation. The simulation model closely reproduced actually observed tPA treatment rate and overall process time (21.8% and 129 min for model outcomes vs. 22.1% and 127 min, P=0.89 and 0.64, respectively). Two barriers were overcome: (1) time spent by ambulance personnel on scene by a scoop-and-run protocol (1.4% increase in tPA rate, 7 min decrease in overall process time), and (2) time to laboratory results by introducing a point-of-care diagnostic device (3.2% increase in tPA rate, 20 min decrease in overall process time). CONCLUSIONS: A simulation-based approach is well suited to efficiently assess solutions to barriers along the overall stroke pathway. Substantial improvements in treatment rates and efficacy of thrombolysis may be achieved by implementing a scoop-and-run protocol and point-of-care device.

Incidence, causative mechanisms, and anatomic localization of stroke in pituitary adenoma patients treated with postoperative radiation therapy versus surgery alone.

PURPOSE: To assess and compare the incidence of stroke and stroke subtype in pituitary adenoma patients treated with postoperative radiation therapy (RT) and surgery alone. METHODS AND MATERIALS: A cohort of 462 pituitary adenoma patients treated between 1959 and 2008 at the University Medical Center Groningen in The Netherlands was studied. Radiation therapy was administered in 236 patients. The TOAST (Trial of ORG 10172 in Acute Stroke Treatment) and the Oxfordshire Community Stroke Project classification methods were used to determine causative mechanism and anatomic localization of stroke. Stroke incidences in patients treated with RT were compared with that observed after surgery alone. Risk factors for stroke incidence were studied by log-rank test, without and with stratification for other significant risk factors. In addition, the stroke incidence was compared with the incidence rate in the general Dutch population. RESULTS: Thirteen RT patients were diagnosed with stroke, compared with 12 surgery-alone patients. The relative risk (RR) for stroke in patients treated with postoperative RT was not significantly different compared with surgery-alone patients (univariate RR 0.62, 95% confidence interval [CI] 0.28-1.35, P=.23). Stroke risk factors were coronary or peripheral artery disease (univariate and multivariate RR 10.4, 95% CI 4.7-22.8, P<.001) and hypertension (univariate RR 3.9, 95% CI 1.6-9.8, P=.002). There was no difference in TOAST and Oxfordshire classification of stroke. In this pituitary adenoma cohort 25 strokes were observed, compared with 16.91 expected (standard incidence ratio 1.48, 95% CI 1.00-1.96, P=.049). CONCLUSIONS: In pituitary adenoma patients, an increased incidence of stroke was observed compared with the general population. However, postoperative RT was not associated with an increased incidence of stroke or differences in causative mechanism or anatomic localization of stroke compared with surgery alone. The primary stroke risk factor was pre-existent coronary or peripheral artery disease.

Extensive validation of the pain disability index in 3 groups of patients with musculoskeletal pain.

STUDY DESIGN: A cross-sectional study design was performed. OBJECTIVE: To validate the pain disability index (PDI) extensively in 3 groups of patients with musculoskeletal pain. SUMMARY OF BACKGROUND DATA: The PDI is a widely used and studied instrument for disability related to various pain syndromes, although there is conflicting evidence concerning factor structure, test-retest reliability, and missing items. Additionally, an official translation of the Dutch language version has never been performed. METHODS: For reliability, internal consistency, factor structure, test-retest reliability and measurement error were calculated. Validity was tested with hypothesized correlations with pain intensity, kinesiophobia, Rand-36 subscales, Depression, Roland-Morris Disability Questionnaire, Quality of Life, and Work Status. Structural validity was tested with independent backward translation and approval from the original authors. RESULTS: One hundred seventy-eight patients with acute back pain, 425 patients with chronic low back pain and 365 with widespread pain were included. Internal consistency of the PDI was good. One factor was identified with factor analyses. Test-retest reliability was good for the PDI (intraclass correlation coefficient, 0.76). Standard error of measurement was 6.5 points and smallest detectable change was 17.9 points. Little correlations between the PDI were observed with kinesiophobia and depression, fair correlations with pain intensity, work status, and vitality and moderate correlations with the Rand-36 subscales and the Roland-Morris Disability Questionnaire. CONCLUSION: The PDI-Dutch language version is internally consistent as a 1-factor structure, and test-retest reliable. Missing items seem high in sexual and professional items. Using the PDI as a 2-factor questionnaire has no additional value and is unreliable.

[Measuring cerebral vasoregulation--the possible clinical implications]. / Het meten van de cerebrale vasoregulatie--mogelijke klinische implicaties.

Cerebral vessels can keep cerebral perfusion more or less constant. This process is called cerebral vasoregulation and can be measured using different neuromonitoring techniques, which will be discussed in this overview. Cerebral perfusion deficits after brain damage caused by a cerebrovascular accident (CVA), subarachnoid haemorrhage (SAH) or severe traumatic skull and brain injury (TSBI) can be detected early and better understood by using these techniques. In current clinical guidelines on the treatment of CVA, SAB and TSBI, impaired cerebral vasoregulation is often assumed. However, there is a need to measure cerebral vasoregulation status at the individual level, with follow-up over time. Some vasoregulation techniques inform the clinician about subtle local regulation disorders ('snapshot' assessment). Other techniques are suitable for the global long-term monitoring of vasoregulation ('monitoring' assessment) where the results could serve as feedback for treatment interventions. Appropriate use of the techniques in daily clinical practice requires standardisation of the methods available for the monitoring of cerebral vasoregulation. Presently, use is mostly restricted to the research setting.

The chain of care enabling tPA treatment in acute ischemic stroke: a comprehensive review of organisational models.

Protracted and partial implementation of treatment with intravenous tissue plasminogen activator (tPA) within 4.5 h after acute stroke onset results in potentially eligible patients not receiving optimal treatment. The goal of this study was to review the performance of various organisational models of acute stroke care delivery, and subsequent attempts to improve implementation of tPA treatment. Publications comprehensively reporting on organisational models to improve implementation of i.v. tPA treatment of acute ischemic stroke patients were selected. The efficacy of organisational models was assessed using process outcome measures: thrombolysis rates, time-dependent operational endpoints (time delays), functional outcomes: safety (rate of symptomatic intracranial hemorrhage, mortality rates) and clinical outcome at 90 days (modified Rankin Scale). Fifty-eight published studies assessing organisational models were identified. Four dominant models of acute stroke care delivery were discerned, i.e., primary and comprehensive stroke centres, telemedicine, and the mobile stroke unit. Performance reported for these models suggest a large variation in administration of thrombolytic therapy (0.7-30 %). Time delays and functional outcomes found varied considerably, just like safety and mortality (0.0-11.5 %, and 3.4-31.9 %, respectively). These findings suggest that improving organisational models for tPA treatment may improve acute stroke care. However, implementation may be hampered by regional variation in acute stroke care capacity, expertise, and a fragmented approach towards organising stroke care.

Clinimetric properties of the EuroQol-5D in patients with chronic low back pain.

BACKGROUND CONTEXT: Clinimetric properties of the EuroQol-5D (EQ-5D) in patients with nonspecific chronic low back pain (CLBP) are largely unknown. PURPOSE: To study the criterion validity, responsiveness, and minimal clinically important change (MCIC) of EQ-5D in patients with CLBP. STUDY DESIGN: Prospective study design carried out in a multispecialist Spine Center in The Netherlands. PATIENT SAMPLE: One hundred fifty-one patients with CLBP. OUTCOME MEASURES: Quality of life (QOL) was measured with EQ-5D, consisting of two scales: one scale measuring QOL with five categorical questions and the other measuring health state on a visual analog scale (0-100). Criterion measures were disability, measured with the Pain Disability Index (PDI) and the Roland Morris Disability Questionnaire (RMDQ), and pain intensity, measured with a numeric rating scale (NRS). METHODS: Pearson correlation coefficients between the EQ-5D and RMDQ, PDI, and NRS were calculated to test the criterion validity. Correlations were interpreted based on predefined criteria. Responsiveness of the EQ-5D was calculated with area under the receiver operating characteristics (ROC) curve. Minimal clinically important change was calculated with the optimal cutoff point under the ROC curve, and sensitivity and specificity were also calculated. RESULTS: Correlations between EQ-5D and criterion measures ranged between 0.39 and 0.59 and were considered moderate to good. Areas under the ROC curve ranged from 0.59 to 0.72 depending on the external criterion and EQ-5D subscale. The MCIC was 0.03 points for the categorical scales of the EQ-5D and 10.5 points for the EQ-5D visual analog scale. CONCLUSIONS: The EQ-5D is a valid and responsive QOL scale in patients with CLBP.

Designing an implementation strategy to improve interprofessional shared decision making in sciatica: study protocol of the DISC study.

BACKGROUND: Sciatica is a common condition worldwide that is characterized by radiating leg pain and regularly caused by a herniated disc with nerve root compression. Sciatica patients with persisting leg pain after six to eight weeks were found to have similar clinical outcomes and associated costs after prolonged conservative treatment or surgery at one year follow-up. Guidelines recommend that the team of professionals involved in sciatica care and patients jointly decide about treatment options, so-called interprofessional shared decision making (SDM). However, there are strong indications that SDM for sciatica patients is not integrated in daily practice. We designed a study aiming to explore the barriers and facilitators associated with the everyday embedding of SDM for sciatica patients. All related relevant professionals and patients are involved to develop a tailored strategy to implement SDM for sciatica patients. METHODS: The study consists of two phases: identification of barriers and facilitators and development of an implementation strategy. First, barriers and facilitators are explored using semi-structured interviews among eight professionals of each (para)medical discipline involved in sciatica care (general practitioners, physical therapists, neurologists, neurosurgeons, and orthopedic surgeons). In addition, three focus groups will be conducted among patients. Second, the identified barriers and facilitators will be ranked using a questionnaire among a representative Dutch sample of 200 GPs, 200 physical therapists, 200 neurologists, all 124 neurosurgeons, 200 orthopedic surgeons, and 100 patients. A tailored team-based implementation strategy will be developed based on the results of the first phase using the principles of intervention mapping and an expert panel. DISCUSSION: Little is known about effective strategies to increase the uptake of SDM. Most implementation strategies only target a single discipline, whereas multiple disciplines are involved in SDM among sciatica patients. The results of this study can be used as an example for implementing SDM in other patient groups receiving multidisciplinary complex care (e.g., elderly) and can be generalized to other countries with similar context, thereby contributing to a worldwide increase of SDM in preference sensitive choices.

Proportion of patients treated with thrombolysis in a centralized versus a decentralized acute stroke care setting.

BACKGROUND AND PURPOSE: Today, treatment of acute stroke consists of tissue-type plasminogen activator (tPA), admission to a stroke unit, and aspirin. Although tPA treatment is the most effective, there is substantial undertreatment. Centralized care may affect rate, timing, and outcome of thrombolysis compared to decentralized treatment in community hospitals. The present study aimed to assess the impact of organizational models on the proportion of patients undergoing tPA treatment. METHODS: A prospective, multicenter, observational study among 13 hospitals in the North of the Netherlands was conducted. In the centralized model, tPA treatment for 4 hospitals was administered in 1 stroke center. The decentralized model comprised 9 community hospitals. Primary outcome was the proportion of patients treated with tPA. Secondary outcome measures were proportion of patients arriving within 4.5 hours, safety, 90-day functional outcome, and onset-to-door, door-to-needle, and onset-to-needle times. Potential confounders were adjusted using logistic regression analysis. RESULTS: Two hundred eighty-three and 801 ischemic stroke patients were enrolled in the centralized and decentralized settings. Numbers of patients treated with tPA were 62 (21.9%) and 113 (14.1%) (OR, 1.72; 95% CI, 1.22-2.43). Adjusting for potential confounders did not alter results (OR, 2.03; 95% CI, 1.39-2.96). In the centralized setting, significantly more patients arrived at the hospital within the 4.5-hour time window (P<0.01), and shorter door-to-needle times were reached (35 versus 47 minutes). Other secondary outcome measures did not differ across setting. CONCLUSIONS: In a centralized setting, the results demonstrate a 50% increased likelihood of treatment. Prehospital factors seem to contribute to this result.

Variations of blood pressure in stroke unit patients may result from alternating body positions.

BACKGROUND: Blood pressure (BP) is one of the major vital parameters monitored in the stroke unit. The accuracy of indirect BP measurement is strongly influenced by the position of both patient and arm during the measurement. Acute stroke patients are often nursed in lateral decubitus positions. The effect of these alternating body positions in relation to affected body side on the outcome and reliability of BP readings in acute stroke patients is unknown. METHODS: An automatic oscillometric BP device was used. BP was measured in both arms in the (back) supine and both lateral decubitus positions. RESULTS: In total, 54 consecutive acute stroke patients were included. Thirty-five patients had right-sided deficits and 19 patients had left-sided deficits. Supine BP readings were similar in the right and left arms regardless of side of deficit. Measurements of BP in the lateral decubitus positions resulted in significantly lower BP readings in the uppermost arm (around 12 mm Hg in both arms) and significantly higher readings in the right lowermost arm (around 6 mm Hg) compared to the supine position. This effect seemed less pronounced when the left lowermost arm was measured. There was no relation between change of BP readings in various lateral positions and side of stroke. CONCLUSIONS: Alternating lateral decubitus positions according to nursing standards in acute stroke patients lead to a mean 18 mm Hg BP fluctuation. This may largely be explained by hydrostatic pressure effects, partly by anatomic factors in the left lowermost arm, but not by the side of stroke.

Responsiveness and minimal clinically important change of the Pain Disability Index in patients with chronic back pain.

STUDY DESIGN: Prospective cohort study. OBJECTIVE: The objective of this study was to test the responsiveness and minimal clinically important change (MCIC) of the Pain Disability Index (PDI) in patients with chronic back pain (CBP). SUMMARY OF BACKGROUND DATA: Treatment of patients with CBP is primarily focused on reduction of disability. For disability measurement, the PDI is a widely used questionnaire. There are, however, no data available on responsiveness and MCIC. METHODS: Two hundred forty-two patients with CBP were included in this study. Patients filled in the PDI at baseline and at discharge. The PDI consists of 2 subscales: 1 measuring voluntary activities and 1 measuring obligatory activities. PDI was anchored at 2 self-reported global perceived effect (GPE) scales for complaints and self-care, respectively. Responsiveness was considered sufficient when Area Under the Receiver Operating Characteristics (ROC) Curve (AUC) was higher than 0.70. To test interpretability, change scores and MCIC were calculated. MCIC was tested by determination of optimal cut-off point of the ROC curve and determination of specificity and sensitivity of the optimal cut-off point. RESULTS: AUCs were 0.76 and 0.77 depending on the external criterion. The subscale obligatory activities did not meet the criteria for responsiveness (AUC: 0.63-0.69). MCIC of the PDI was 9.5 points for GPE "complaints" and 8.5 for GPE "self-care." CONCLUSION: The total score of the PDI as well as the subscale of voluntary activities is responsive. Partly because of floor effects, the subscale obligatory activities are not sufficiently responsive in patients with CBP. However, the responsiveness of this subscale in other patient groups should be further tested. In patients with CBP, change can be considered clinically important when PDI score has decreased 8.5 to 9.5 points.