Search

Abstract Background Early interventions proved to be able to improve prognosis in acute stroke patients. Prompt identification of symptoms, organised timely and efficient transportation towards appropriate facilities, become essential part of effective treatment. The implementation of an evidence based pre-hospital stroke care pathway may be a method for achieving the organizational standards required to grant appropriate care. We performed a systematic search for studies evaluating the effect of pre-hospital and emergency interventions for suspected stroke patients and we found that there seems to be only a few studies on the emergency field and none about implementation of clinical pathways. We will test the hypothesis that the adoption of emergency clinical pathway improves early diagnosis and referral in suspected stroke patients. We designed a cluster randomised controlled trial (C-RCT), the most powerful study design to assess the impact of complex interventions. The study was registered in the Current Controlled Trials Register: ISRCTN41456865 – Implementation of pre-hospital emergency pathway for stroke – a cluster randomised trial. Methods/design Two-arm cluster-randomised trial (C-RCT). 16 emergency services and 14 emergency rooms were randomised either to arm 1 (comprising a training module and administration of the guideline), or to arm 2 (no intervention, current practice). Arm 1 participants (152 physicians, 280 nurses, 50 drivers) attended an interactive two sessions course with continuous medical education CME credits on the contents of the clinical pathway. We estimated that around 750 patients will be met by the services in the 6 months of observation. This duration allows recruiting a sample of patients sufficient to observe a 30% improvement in the proportion of appropriate diagnoses. Data collection will be performed using current information systems. Process outcomes will be measured at the cluster level six months after the intervention. We will assess the guideline recommendations for emergency and pre-hospital stroke management relative to: 1) promptness of interventions for hyperacute ischaemic stroke; 2) promptness of interventions for hyperacute haemorrhagic stroke 3) appropriate diagnosis. Outcomes will be expressed as proportions of patients with a positive CT for ischaemic stroke and symptoms onset Discussion The fields in which this trial will play are usually neglected by Randomised Controlled Trial (RCT). We have chosen the Cluster-randomised Controlled Trial (C-RCT) to address the issues of contamination, adherence to real practice, and community dimension of the intervention, with a complex definition of clusters and an extensive use of routine data to collect the outcomes.

Background Timely and appropriate hospital treatment of acute cerebrovascular diseases (stroke and Transient Ischemic Attacks - TIA) improves patient outcomes. Emergency Medical Service (EMS) dispatchers who can identify cerebrovascular disease symptoms during telephone requests for emergency service also contribute to these improved outcomes. The Italian Ministry of Health issued guidelines on the management of AC patients in pre-hospital emergency service, including Cincinnati Prehospital Stroke Scale (CPSS) use. We measured the sensitivity and Positive Predictive Value (PPV) of EMS dispatchers' ability to recognize stroke/TIA symptoms and evaluated whether the CPSS improves accuracy. Methods A cross-sectional multicentre study was conducted to collect data from 38 Italian emergency operative centres on all cases identified with stroke/TIA symptoms at the time of dispatch and all cases with stroke/TIA symptoms identified on the scene by the ambulance personnel from November 2010 to May 2011. Results The study included 21760 cases: 18231 with stroke/TIA symptoms at dispatch and 9791 with symptoms confirmed on the scene. The PPV of the dispatch stroke/TIA symptoms identification was 34.3% (95% CI 33.7-35.0; 6262/18231) and the sensitivity was 64.0% (95% CI 63.0-64.9; 6262/9791). Centres using CPSS more often (>10% of cases) had both higher PPV (56%; CI 95% 57-60 vs 18%; CI 95% 17-19) and higher sensitivity (71%; CI 95% 87-89 vs 52%; CI 95% 51-54). In the multivariate regression a centre's CPSS use was associated with PPV (beta 0.48 p = 0.014) and negatively associated with sensitivity (beta ?0.36; p = 0.063); centre sensitivity was associated with CPSS (beta 0.32; p = 0.002), adjusting for PPV. Conclusions Centres that use CPSS more frequently during phone dispatch showed greater agreement with on-the-scene prehospital assessments, both in correctly identifying more cases with stroke/TIA symptoms and in giving fewer false positives for non-stroke/TIA cases. Our study shows an extreme variability in the performance among OCs, highlighting that form many centres there is room for improvement in both sensitivity and positive predictive value of the dispatch. Our results should be used for benchmarking proposals in the effort to identify best practices across the country. [ABSTRACT FROM AUTHOR]

Background: Emergency Clinical Pathways (ECP) for stroke have never been tested in randomizedcontrolled trials (RCTs). Objective: To evaluate the effectiveness of an ECP for stroke patients in Latium (Italy) emergency system. Methods: cluster-RCT designed to compare stroke patient referrals by Emergency Medical Service (EMS) and Emergency Room (ER) health professionals trained in the ECP, with those of non-trained EMS and ER controls. Primary outcome measure was the proportion of eligible (aged = 80 and symptom onset = 6 hours) stroke patients referred to a stroke unit (SU). Intention to treat (ITT) and per-protocol (PP) analyses were performed, and risk ratios (RR) adjusted by age, gender and area, were calculated. Results: 2656 patients in the intervention arm and 2239 in the control arm required assistance; 78.3% of the former and 80.6% of the latter were admitted to hospitals, and respectively 74.8% and 78.3% were confirmed strokes. Of the eligible confirmed strokes, 106/434 (24.4%) in the intervention arm and 43/328 (13.1%) in the control arm were referred to the SU in the ITT analysis (RR = 2.01; 95% CI: 0.79-4.00), and respectively 105/243 (43.2%) and 43/311 (13.8%) in the PP analysis (RR = 3.21; 95%CI: 1.62-4.98). Of patients suitable for i.v. thrombolysis, 15/175 (8.6%) in the intervention arm and 2/115 (1.7%) in the control arm received thrombolysis (p = 0.02) in the ITT analysis, and respectively 15/99 (15.1%) and 2/107 (1.9%)(p = 0.001) in the PP analysis. Conclusion: Our data suggest potenti efficiency and feasibility of an ECP. The integration of EMS and ERs with SU networks for organised acute stroke care is feasible and may ameliorate the quality of care for stroke patients. Trial registration: Current Controlled Trials (ISRCTN41456865). [ABSTRACT FROM AUTHOR]

Background: The cytological screening programme of Viterbo has completed the second round of invitations to the entire target population (age 25-64). From a public health perspective, it is important to know the Pap-test coverage rate and the use of opportunistic screening. The most commonly used study design is the survey, but the validity of self-reports and the assumptions made about non respondents are often questioned. Methods: From the target population, 940 women were sampled, and responded to a telephone interview about Pap-test utilisation. The answers were compared with the screening program registry; comparing the dates of Pap-tests reported by both sources. Sensitivity analyses were performed for coverage over a 36-month period, according to various assumptions regarding non respondents. Results: The response rate was 68%. The coverage over 36 months was 86.4% if we assume that non respondents had the same coverage as respondents, 66% if we assume they were not covered at all, and 74.6% if we adjust for screening compliance in the non respondents. The sensitivity and specificity of the question, "have you ever had a Pap test with the screening programme" were 84.5% and 82.2% respectively. The test dates reported in the interview tended to be more recent than those reported in the registry, but 68% were within 12 months of each other. Conclusion: Surveys are useful tools to understand the effectiveness of a screening programme and women's self-report was sufficiently reliable in our setting, but the coverage estimates were strongly influenced by the assumptions we made regarding non respondents. [ABSTRACT FROM AUTHOR]

Abstract Background Emergency Clinical Pathways (ECP) for stroke have never been tested in randomized controlled trials (RCTs). Objective To evaluate the effectiveness of an ECP for stroke patients in Latium (Italy) emergency system. Methods cluster-RCT designed to compare stroke patient referrals by Emergency Medical Service (EMS) and Emergency Room (ER) health professionals trained in the ECP, with those of non-trained EMS and ER controls. Primary outcome measure was the proportion of eligible (aged ≤ 80 and symptom onset ≤ 6 hours) stroke patients referred to a stroke unit (SU). Intention to treat (ITT) and per-protocol (PP) analyses were performed, and risk ratios (RR) adjusted by age, gender and area, were calculated. Results 2656 patients in the intervention arm and 2239 in the control arm required assistance; 78.3% of the former and 80.6% of the latter were admitted to hospitals, and respectively 74.8% and 78.3% were confirmed strokes. Of the eligible confirmed strokes, 106/434 (24.4%) in the intervention arm and 43/328 (13.1%) in the control arm were referred to the SU in the ITT analysis (RR = 2.01; 95% CI: 0.79–4.00), and respectively 105/243 (43.2%) and 43/311 (13.8%) in the PP analysis (RR = 3.21; 95%CI: 1.62–4.98). Of patients suitable for i.v. thrombolysis, 15/175 (8.6%) in the intervention arm and 2/115 (1.7%) in the control arm received thrombolysis (p = 0.02) in the ITT analysis, and respectively 15/99 (15.1%) and 2/107 (1.9%)(p = 0.001) in the PP analysis. Conclusion Our data suggest potenti efficiency and feasibility of an ECP. The integration of EMS and ERs with SU networks for organised acute stroke care is feasible and may ameliorate the quality of care for stroke patients. Trial registration Current Controlled Trials (ISRCTN41456865).