The Spinal Cord Independence Measure (SCIM) version III: reliability and validity in a multi-center international study

PURPOSE: To examine the third version of the Spinal Cord Independence Measure (SCIM III) for reliability and validity in a multi-center cohort study. METHOD: Four hundred and twenty-five patients with spinal cord lesions from 13 spinal cord units in six countries from three continents were assessed with SCIM III and the Functional Independence measure (FIM) on admission to rehabilitation and before discharge. RESULTS: Total agreement between raters was above 80% in most SCIM III tasks, and all kappa coefficients were statistically significant (P<0.001). The coefficients of Pearson correlation between the paired raters were above 0.9, and intraclass correlation coefficients were above 0.94. Cronbach's alpha was above 0.7. The coefficient of Pearson correlation between FIM and SCIM III was 0.790 (P<0.01). SCIM III was more responsive to changes than FIM in the subscales of Respiration and sphincter management and Mobility indoors and outdoors. CONCLUSIONS: The results support the reliability and validity of SCIM III in a multi-cultural setup. Despite several limitations of the study, the results indicate that SCIM III is an efficient measure for functional assessment of SCL patients and can be safely used for clinical and research trials, including international multi-center studies.     

The Spinal Cord Independence Measure (SCIM) version III: Reliability and validity in a multi-center international study

Purpose. To examine the third version of the Spinal Cord Independence Measure (SCIM III) for reliability and validity in a multi-center cohort study.

Method. Four hundred and twenty-five patients with spinal cord lesions from 13 spinal cord units in six countries from three continents were assessed with SCIM III and the Functional Independence measure (FIM) on admission to rehabilitation and before discharge.

Results. Total agreement between raters was above 80% in most SCIM III tasks, and all kappa coefficients were statistically significant (P < 0.001). The coefficients of Pearson correlation between the paired raters were above 0.9, and intraclass correlation coefficients were above 0.94. Cronbach's α was above 0.7. The coefficient of Pearson correlation between FIM and SCIM III was 0.790 (P < 0.01). SCIM III was more responsive to changes than FIM in the subscales of Respiration and sphincter management and Mobility indoors and outdoors.

Conclusions. The results support the reliability and validity of SCIM III in a multi-cultural setup. Despite several limitations of the study, the results indicate that SCIM III is an efficient measure for functional assessment of SCL patients and can be safely used for clinical and research trials, including international multi-center studies.     

The international PROGRESS registry of patients with severe sepsis: drotrecogin alfa (activated) use and patient outcomes

Introduction  

Since the launch of drotrecogin alfa activated (DrotAA), institutions and individual countries have published data on its use in clinical practice, based on audit or registry data. These studies were limited in size and geographic locale and included patients with greater disease severity and higher mortality than those in clinical trials. The purpose of this study was to compare baseline characteristics and clinical outcomes (using appropriate statistical adjustments) of patients treated or not treated with DrotAA from the international PROGRESS (Promoting Global Research Excellence in Severe Sepsis) cohort study of severe sepsis.     

Real-life global survey evaluating patients with atrial fibrillation (REALISE-AF): results of an international observational registry

Despite being one of the most studied arrhythmias, there is paucity of information regarding atrial fibrillation (AF) control in the general population and the treatment strategies utilized by healthcare providers. REALISE-AF is an ongoing international registry investigating the management of AF and its control in nonhospitalized subjects. The registry has enrolled patients in 26 countries worldwide with the primary aim to determine the control of AF. This article presents a review of the initial results from the REALISE-AF registry and compares it to major practice-changing clinical trials conducted in the past. It also gives an overview of the current management strategies, recent updates in treatment and what further developments portend in the future.     

Family Access to a Dentist Study (FADS): A multi-center randomized controlled trial

IntroductionMany low-income parent/caregivers do not understand the importance of cavity-free primary (baby) teeth and the chronic nature of dental caries (tooth decay). As a consequence, dental preventive and treatment utilization is low even when children are screened in schools and referred for care. This study aims to test a referral letter and Dental Information Guide (DIG) designed using the Common-Sense Model of Self-Regulation (CSM) framework to improve caregivers' illness perception of dental caries and increase utilization of care by children with restorative dental needs.MethodsA multi-site randomized controlled trial with caregivers of Kindergarten to 4th grade children in urban Ohio and rural Washington State will compare five arms: (1) CSM referral letter alone; (2) CSM referral letter + DIG; (3) reduced CSM referral letter alone; (4) reduced CSM referral letter + DIG; and (5) standard (control) referral. At baseline, children will be screened at school to determine restorative dental needs. If in need of treatment, caregivers will be randomized to study arms and an intervention packet will be sent home. The primary outcome will be dental care based on a change in oral health status by clinical examination 7 months post-screening (ICDAS sealant codes 1 and 2; restoration codes 3–8; extraction). Enrollment commenced summer 2015 with results in summer 2016.ConclusionThis study uses the CSM framework to develop and test behavioral interventions to increase dental utilization among low-income caregivers. If effective this simple intervention has broad applicability in clinical and community-based settings.     

Use of recombinant activated factor VII (Novoseven) in trauma and surgery: analysis of outcomes reported to an international registry

The objective was to evaluate the efficacy and safety of recombinant activated factor VII in patients with massive bleeding. Forty-five patients with severe massive hemorrhage requiring>or= 14 transfusion units of packed red blood cells received recombinant activated factor VII. Postdrug blood loss and transfusion requirements were assessed, and mortality was compared with predicted outcomes. Blood loss was markedly reduced in 40 of 43 (93.0%) patients, and transfusion requirements decreased after recombinant activated factor VII administration. Mortality rate in trauma patients who had massive hemorrhage was significantly reduced compared with predictions using scoring systems. This may be associated with the use of recombinant activated factor VII. This study failed to demonstrate an improvement in surgical patients. The absence of concurrent controls prevents definitive conclusions regarding actual safety or efficacy of recombinant activated factor VII.     

Outcome measures in major trauma care: a review of current international trauma registry practice

Multiple reports over the past 20 years have criticised the care delivered to major trauma patients in England. The setting up of regional trauma networks is well underway to address these deficiencies. Outcomes currently collected in major trauma are restricted to mortality rates and process measures; however, many patients are left with long-term disabilities and reduced quality of life (QoL), which are not measured at present. Trauma systems need to develop outcome measures that capture this important information to judge the quality of care and influence the development of services. This review aimed to identify the current practice of international trauma registries with regard to outcome measurement and review the literature surrounding these measures. An internet-based search of international trauma registry websites including data dictionaries and annual reports was carried out as well as a literature review to determine what outcome measures are routinely collected by trauma registries. All registries were found to look at mortality and process measures, but only one registry routinely collected morbidity outcome measures for both adults and children. There is a considerable amount of disability and reduced QoL in survivors of major trauma that lasts for years following the injury. At present only the Victorian State Trauma Registry collects outcome measures that evaluate the extent of this. English regional trauma networks and the Trauma Audit and Research Network have the opportunity to learn from this experience and routinely start to collect measures of outcome that can drive service improvement and reduce patient morbidity.     

Coagulometer international sensitivity index (ISI) derivation,a rapid method using the prothrombin time/international normalized ratio (PT/INR) Line: a multicenter study

Summary. Background: The original WHO procedure for prothrombin time (PT) standardization has been almost entirely abandoned because of the universal use of PT coagulometers. These often give different international normalized ratio (INR) results from the manual method, between individual makes of instruments and with instruments from the same manufacture. Method A simple procedure is required to derive local INR with coagulometers. The PT/INR Line method has recently been developed using five European Concerted Action on Anticoagulation (ECAA) certified plasmas to derive local INR. This procedure has been modified to derive a coagulometer PT/INR Line providing International Sensitivity Index (ISI) and mean normal PT (MNPT) for coagulometers and give local INR. Results have been compared with conventional ISI calibrations at the same laboratories. Results: With human thromboplastins, mean ISI by local calibration was 0.93 (range: 0.77–1.16). With the PT/INR Line, mean coagulometer ISI was higher, for example 0.99 (0.84–1.23) but using the PT/INR Line derived MNPT there was no difference in local INR. Between‐centre INR variation of a certified validation plasma was reduced with human and bovine reagents after correction with local ISI calibrations and the PT/INR Line. Conclusion: The PT/INR Line–ISI with its derived MNPT is shown to provide reliable local INR with the 13 different reagent/coagulometer combinations at the 28 centres in this international study.     

Quality management in resuscitation--towards a European cardiac arrest registry (EuReCa)

Background

Knowledge about the epidemiology of cardiac arrest in Europe is inadequate.

Aim

To describe the first attempt to build up a Common European Registry of out-of-hospital cardiac arrest, called EuReCa.

Methods

After approaching key persons in participating countries of the European Resuscitation Council, five countries or areas within countries (Belgium, Germany, Andalusia, North Holland, Sweden) agreed to participate. A standardized questionnaire including 28 items, that identified various aspects of resuscitation, was developed to explore the nature of the regional/national registries. This comprises inclusion criteria, data sources, and core data, as well as technical details of the structure of the databases.

Results

The participating registers represent a population of 35 million inhabitants in Europe. During 2008, 12,446 cardiac arrests were recorded. The structure as well as the level of complexity varied markedly between the 5 regional/national registries. The incidence of attempted resuscitation ranged between registers from 17 to 53 per 100,000 inhabitants each year whilst the number of patients admitted to hospital alive ranged from 5 to 18 per 100,000 inhabitants each year. Bystander CPR varied 3-fold from 20% to 60%.

Conclusion

Five countries agreed to participate in an attempt to build up a common European Registry for out-of-hospital cardiac arrest. These regional/national registries show a marked difference in terms of structure and complexity. A marked variation was found between countries in the number of reported resuscitation attempts, the number of patients brought to hospital alive, and the proportion that received bystander CPR. At present, we are unable to explain the reason for the variability but our first findings could be a ‘wake-up-call’ for building up a high quality registry that could provide answers to this and other key questions in relation to the management of out-of-hospital cardiac arrest.     

New developments in the conduct and management of multi-center trials: an international review of clinical trial units

Summary— There is an urgent need for the performance of more, better designed, and better managed randomized clinical trials. After visits to 43 leading organizations and units involved in clinical trials in Europe and North America during 1993, the way of conducting randomized clinical trials was analyzed. By using a structured questionnaire, information on recent improvements in the way randomized clinical trials are performed was identified. These developments encompass human aspects (better information, collaboration, and communication) as well as non-human aspects (press button phone randomization and data management systems). By employing such developments, randomized clinical trials can run much more efficiently. This facilitates faster and better answers to the questions addressed by randomized clinical trials, thereby also making them more ethical.