Implementation of the Modified Canadian C-Spine Rule by Paramedics.

STUDY OBJECTIVE: The Canadian C-spine rule was modified and validated for use by the paramedics in a multicenter study where patients were assessed with the Canadian C-spine rule yet all transported with immobilization. This study evaluated the clinical impact of the modified Canadian C-spine rule when implemented by paramedics. METHODS: This single-center prospective cohort implementation study took place in Ottawa, Canada (from 2011 to 2015). Advanced and primary care paramedics were trained to use the modified Canadian C-spine rule, collect data on a standardized study form, and selectively transport eligible patients without immobilization. We evaluated all consecutive low-risk adult patients (Glasgow Coma Scale [GCS] 15, stable vital signs) at risk for a neck injury. We followed all patients without initial radiologic evaluation for 30 days. Analyses included descriptive statistics with 95% confidence intervals (CI), sensitivity, specificity, and kappa coefficients. RESULTS: The 4,034 enrolled patients had a mean age of 43 (range 16 to 99), and 53.4% were female. Motor vehicle collisions were the most common mechanism of injury (55.1%), followed by falls (23.9%). There were 11 clinically important injuries. The paramedics classified these injuries with a sensitivity of 90.9% (95% CI, 58.7 to 99.8) and specificity of 66.5% (95% CI, 65.1 to 68.0). There was no adverse event or resulting spinal cord injury. The kappa agreement between paramedics and investigators was 0.94. A total of 2,583 (64.0%) immobilizations were avoided using the modified Canadian C-spine rule. CONCLUSION: Paramedics could accurately apply the modified Canadian C-spine rule to low-risk trauma patients and significantly reduce the need for spinal immobilization during transport. This resulted in no adverse event or any spinal cord injury.

Multi-centre implementation of an Educational program to improve the Cardiac Arrest diagnostic accuracy of ambulance Telecommunicators and survival outcomes for sudden cardiac arrest victims: the EduCATe study design and methodology.

BACKGROUND: Sudden cardiac death remains a leading cause of mortality in Canada, resulting in more than 35,000 deaths annually. Most cardiac arrest victims collapse in their own home (85% of the time) and 50% are witnessed by a family member or bystander. Survivors have a quality of life similar to the general population, but the overall survival rate for out-of-hospital cardiac arrest (OHCA) rarely exceeds 8%. Victims are almost four times more likely to survive when receiving bystander CPR, but bystander CPR rates have remained low in Canada over the past decade, not exceeding 15-25% until recently. Telecommunication-assisted CPR instructions have been shown to significantly increase bystander CPR rates, but agonal breathing may be misinterpreted as a sign of life by 9-1-1 callers and telecommunicators, and is responsible for as much as 50% of missed OHCA diagnoses. We sought to improve the ability and speed with which ambulance telecommunicators can recognize OHCA over the phone, initiate timely CPR instructions, and improve survival. METHODS: In this multi-center national study, we will implement and evaluate an educational program developed for ambulance telecommunicators using a multiple baseline interrupted time-series design. We will compare outcomes 12 months before and after the implementation of a 20-min theory-based educational video addressing barriers to recognition of OHCA while in the presence of agonal breathing. Participating Canadian sites demonstrated prior ability to collect standardized data on OHCA. Data will be collected from eligible 9-1-1 recordings, paramedic documentation and hospital medical records. Eligible cases will include suspected or confirmed OHCA of presumed cardiac origin in patients of any age with attempted resuscitation. DISCUSSION: The ability of telecommunication-assisted CPR instructions to improve bystander CPR and survival rates for OHCA victims is undeniable. The ability of telecommunicators to recognize OHCA over the phone is unequivocally impeded by relative lack of training on agonal breathing, and reluctance to initiate CPR instructions when in doubt. Our pilot data suggests the potential impact of this project will be to increase absolute OHCA recognition and bystander CPR rates by at least 10%, and absolute out-of-hospital cardiac arrest survival by 5% or more. TRIAL REGISTRATION: Prospectively registered on March 28, 2019 at ClinicalTrials.gov identifier: NCT03894059 .

Barriers and facilitators to CPR knowledge transfer in an older population most likely to witness cardiac arrest: a theory-informed interview approach.

BACKGROUND: We sought to identify perceived barriers and facilitators to cardiopulmonary resuscitation (CPR) training and performing CPR among people above the age of 55 years. METHODS: We conducted semistructured qualitative interviews with a purposive sample of independent-living individuals aged 55 years and older from urban and rural settings. We developed an interview guide based on the constructs of the Theory of Planned Behaviour, which elicits salient attitudes, social influences and control beliefs potentially influencing CPR training and performance. Interviews were recorded, transcribed verbatim and analysed until achieving data saturation. Two independent reviewers performed inductive analyses to identify emerging themes, and ranked them by way of consensus. RESULTS: Demographics for the 24 interviewees: mean age 71.4 years, women 58.3%, urban location 75.0%, single dwelling 58.3%, CPR training 79.2% and prior CPR on real victim 8.3%. Facilitators of CPR training included: (1) classes in a convenient location; (2) more advertisements; and (3) having a spouse. Barriers to taking CPR training included: (1) perception of physical limitations; (2) time commitment; and (3) cost. Facilitators of providing CPR included: (1) 9-1-1 CPR instructions; (2) reminders/pocket cards; and (3) frequent but brief updates. Barriers to providing CPR included: (1) physical limitations; (2) lack of confidence; and (3) ambivalence of duty to act in a large group. CONCLUSIONS: We identified key facilitators and barriers for CPR training and performance in a purposive sample of individuals aged 55 years and older.

Multi-phase implementation of automated external defibrillator use by nurses during in-hospital cardiac arrest and its impact on survival.

OBJECTIVE: We sought to evaluate the impact of a medical directive allowing nurses to use defibrillators in automated external defibrillator-mode (AED) on in-hospital cardiac arrest (IHCA) outcomes. METHODS: We completed a health record review of consecutive IHCA for which resuscitation was attempted using a pragmatic multi-phase before-after cohort design. We report Utstein outcomes before (Jan.2012-Aug.2013;Control) the implementation of the AED medical directive following usual practice (Sept.2013-Aug.2016;Phase 1), and following the addition of a theory-based educational video (Sept.2016-Dec.2017;Phase 2). RESULTS: There were 753 IHCA with the following characteristics (Before n = 195; Phase 1n = 372; Phase 2n = 186): mean age 66, 60.0% male, 79.3% witnessed, 29.1% noncardiac-monitored medical ward, 23.9% cardiac cause, and initial ventricular fibrillation/tachycardia (VF/VT) 27.2%. Comparing the Before, Phase 1 and 2: an AED was used 0 time (0.0%), 21 times (5.7%), 15 times (8.1%); mean times to 1st analysis were 7 min, 3 min and 1 min (p < 0.0001); mean times to 1st shock were 12 min, 10 min and 8 min (p = 0.32); return of spontaneous circulation (ROSC) was 63.6%, 59.4% and 58.1% (p = 0.77); survival was 24.6%, 21.0% and 25.8% (p = 0.37). Among IHCA in VF/VT (n = 165), time to 1st analysis and 1st shock decreased by 5 min (p = 0.01) and 6 min (p = 0.23), and ROSC and survival increased by 3.0% (p = 0.80) and 15.6% (p = 0.31). There was no survival benefit overall (1.2%; p = 0.37) or within noncardiac-monitored areas (-7.2%; p = 0.24). CONCLUSIONS: The implementation of a medical directive allowing for AED use by nurses successfully improved key outcomes for IHCA victims, particularly following the theory-based education video and among the VF/VT group.

Impact of a COVID-19 code blue protocol on resuscitation care and CPR quality during in-hospital cardiac arrest.

OBJECTIVE: We sought to evaluate the impact of a COVID-19 Code Blue policy on in-hospital cardiac arrest (IHCA) processes of care, cardiopulmonary resuscitation (CPR) quality metrics, and survival to hospital discharge. METHODS: We completed a health record review of consecutive IHCA for which resuscitation was attempted. We report Utstein outcomes and CPR quality metrics 33 months before (July,2017-March,2020) and after (April,2020-December,2022) the implementation of a COVID-19 Code Blue policy requiring all team members to don personal protective equipment including gown, gloves, mask, and eye protection for all IHCA. RESULTS: There were 800 IHCA with the following characteristics (Before n = 396; After n = 404): mean age 66, 62.9% male, 81.3% witnessed, 31.3% in the emergency department, 25.6% cardiac cause, and initial shockable rhythm in 16.7%. Among all 404 patients screened for COVID-19, 25 of 288 available test results before IHCA occurred were positive. Comparing the before and after periods: there were relevant time delays (min:sec) in start of chest compressions (0:17vs.0:37;p = 0.005), team arrival (0:43vs.1:21;p = 0.002), 1st rhythm analysis (1:15vs.3:16;p < 0.0001), 1st epinephrine (3:44vs.4:34;p = 0.02), and airway insertion (8:38vs. 10:18;p = 0.02). Resuscitation duration was similar (18:28vs.19:35;p = 0.34). Exception of peri-shock pause which appeared longer (0:06vs.0:14;p = 0.07), chest compression fraction, rate and depth were identical and good. Factors independently associated with survival were age (adjOR 0.98;p < 0.001), male sex (adjOR 1.51;p = 0.048), witnessed (adjOR 2.35;p = 0.02), shockable rhythm (adjOR 3.31;p < 0.0001), hospital location (p = 0.0002), and COVID-19 period (adjOR 0.68;p = 0.052). CONCLUSIONS: The COVID-19 Code Blue policy was associated with delayed processes of care but similarly good CPR quality. The COVID-19 period appeared associated with decreased survival.

Factors associated with the successful recognition of abnormal breathing and cardiac arrest by ambulance communications officers: a qualitative iterative survey.

OBJECTIVES: We sought to identify barriers and facilitators to ambulance communications officers' (ACOs') recognition of abnormal breathing and administration of cardiopulmonary resuscitation (CPR) instructions. METHODS: We conducted semistructured qualitative interviews based on the constructs of the Theory of Planned Behavior to elicit salient attitudes, social influences, and behavioral controls potentially influencing ACOs' intent to recognize abnormal breathing as a symptom of cardiac arrest and administer CPR instructions over the phone. We conducted interviews until achieving data saturation. We recorded interviews and transcribed them verbatim. Two independent reviewers performed inductive analyses to identify emerging themes. RESULTS: We interviewed 24 ACOs from four Canadian provinces (67% female, median 9.5 years of experience, 33% with paramedic training). We identified eight behavioral, 14 subjective normative, and 22 control beliefs. Important attitudes were as follows: 1) CPR instructions may help the patient and are likely to be beneficial for the caller; 2) abnormal breathing is an early sign of cardiac arrest; and 3) dispatch-assisted CPR instructions can improve survival. The leading social influence was management/quality assurance staff. Behavioral control was the construct most associated with ACOs' ability to recognize abnormal breathing, including 1) adherence to mandatory scripted protocol, 2) poor caller description of breathing pattern, and 3) ACO training on abnormal breathing. CONCLUSIONS: This qualitative study found that control beliefs are most influential on ACOs' intention to recognize abnormal breathing and provide CPR instructions over the phone. Training and policy changes should target these beliefs to increase the frequency of ACO-administered CPR instructions to callers reporting a patient in cardiac arrest.

Evaluation of the safety of C-spine clearance by paramedics: design and methodology.

BACKGROUND: Canadian Emergency Medical Services annually transport 1.3 million patients with potential neck injuries to local emergency departments. Less than 1% of those patients have a c-spine fracture and even less (0.5%) have a spinal cord injury. Most injuries occur before the arrival of paramedics, not during transport to the hospital, yet most patients are transported in ambulances immobilized. They stay fully immobilized until a bed is available, or until physician assessment and/or X-rays are complete. The prolonged immobilization is often unnecessary and adds to the burden of already overtaxed emergency medical services systems and crowded emergency departments. METHODS/DESIGN: The goal of this study is to evaluate the safety and potential impact of an active strategy that allows paramedics to assess very low-risk trauma patients using a validated clinical decision rule, the Canadian C-Spine Rule, in order to determine the need for immobilization during transport to the emergency department.This cohort study will be conducted in Ottawa, Canada with one emergency medical service. Paramedics with this service participated in an earlier validation study of the Canadian C-Spine Rule. Three thousand consecutive, alert, stable adult trauma patients with a potential c-spine injury will be enrolled in the study and evaluated using the Canadian C-Spine Rule to determine the need for immobilization. The outcomes that will be assessed include measures of safety (numbers of missed fractures and serious adverse outcomes), measures of clinical impact (proportion of patients transported without immobilization, key time intervals) and performance of the Rule. DISCUSSION: Approximately 40% of all very low-risk trauma patients could be transported safely, without c-spine immobilization, if paramedics were empowered to make clinical decisions using the Canadian C-Spine Rule. This safety study is an essential step before allowing all paramedics across Canada to selectively immobilize trauma victims before transport. Once safety and potential impact are established, we intend to implement a multi-centre study to study actual impact.

Evaluating the paramedic application of the prehospital Canadian C-Spine Rule in sport-related injuries.

OBJECTIVES: We sought to compare the ability of the prehospital Canadian C-Spine Rule to selectively recommend immobilization in sport-related versus non-sport-related injuries and describe sport-related mechanisms of injury. METHODS: We reviewed data from the prospective paramedic Canadian C-Spine Rule validation and implementation studies in 7 Canadian cities. A trained reviewer further categorized sport-related mechanisms of injury collaboratively with a sport medicine physician using a pilot-tested standardized form. We compared the Canadian C-Spine Rule's recommendation to immobilize sport-related versus non-sport-related patients using Chi-square and relative risk statistics with 95% confidence intervals. RESULTS: There were 201 sport-related patients among the 5,978 included. Sport-related injured patients were younger (mean age 36.2 vs. 42.4) and more predominantly male (60.5% vs. 46.8%) than non-sport-related patients. Paramedics did not miss any C-Spine injury when using the Canadian C-Spine Rule. C-Spine injury rates were similar between sport (2/201; 1.0%) and non-sport-injured patients (47/5,777; 0.8%). The Canadian C-Spine Rule recommended immobilization equally between groups (46.4% vs. 42.5%; RR 1.09 95%CI 0.93-1.28), most commonly resulting from a dangerous mechanism among sport-injured (68.7% vs. 54.5%; RR 1.26 95%CI 1.08-1.47). The most common dangerous mechanism responsible for immobilization in sport was axial load. CONCLUSION: Although equal proportions of sport and non-sport-related injuries were immobilized, a dangerous mechanism was most often responsible for immobilization in sport-related cases. These findings do not address the potential impact of using the Canadian C-Spine Rule to evaluate collegiate or pro athletes assessed by sport medicine physicians. It does support using the Canadian C-Spine Rule as a tool in sport-injured patients assessed by paramedics.

RéSUMé: OBJECTIFS: Nous avons cherché à comparer la capacité préhospitalière de la Canadian C-spine Rule à recommander de façon sélective l'immobilisation dans les blessures liées au sport par rapport aux blessures non liées au sport et à décrire les mécanismes des blessures liés au sport. LES MéTHODES: Nous avons examiné les données des études prospectives de validation et de mise en œuvre de la règle canadienne de la colonne vertébrale dans sept villes canadiennes. Un examinateur qualifié a ensuite classé les mécanismes de blessure liés au sport, en collaboration avec un médecin du sport, à l'aide d'un formulaire standardisé testé dans le cadre d'un projet pilote. Nous avons comparé la recommandation de la Canadian C-Spine Rule d'immobiliser les patients liés au sport par rapport aux patients non liés au sport en utilisant les statistiques du chi carré et du risque relatif avec un intervalle de confiance de 95 %. RéSULTATS: Parmi les 5 978 patients inclus il y avait 201 patients liés au sport. Les patients blessés liés au sport étaient plus jeunes (âge moyen 36,2 ans contre 42,4 ans) et plus majoritairement de sexe masculin (60,5 % contre 46,8 %) que les patients non liés au sport. Les ambulanciers paramédicaux n'ont manqué aucune blessure au rachis cervical lorsqu'ils ont utilisé la Canadian C-spine Rule. Les taux de blessures au rachis cervical étaient semblables chez les patients sportifs (2/201 ; 1,0 %) et non sportifs (47/5 777 ; 0,8 %). La Canadian C-spine Rule recommande l'immobilisation de manière égale entre les groupes (46,4 % contre 42,5 % ; RR 1,09 95 % IC 0,93-1,28), le plus souvent en raison d'un mécanisme dangereux chez les sportifs blessés (68,7 % contre 54,5 % ; RR 1,26 95 % IC 1,08-1,47). Le mécanisme dangereux le plus souvent responsable de l'immobilisation dans le sport était la charge axiale. CONCLUSION: Bien que des proportions égales de blessures sportives et non sportives aient été immobilisées, un mécanisme dangereux était le plus souvent responsable de l'immobilisation dans les cas liés au sport. Ces conclusions n'abordent pas l'impact potentiel de l'utilisation de la Canadian C-spine Rule pour évaluer les athlètes collégiaux ou professionnels évalués par les médecins du sport. Elle est favorable à l'utilisation de la Canadian C-spine Rule comme outil pour les patients blessés par le sport et évalués par les ambulanciers.

Pragmatic Strategy Empowering Paramedics to Assess Low-Risk Trauma Patients With the Canadian C-Spine Rule and Selectively Transport Them Without Immobilization: Protocol for a Stepped-Wedge Cluster Randomized Trial.

BACKGROUND: Each year, half a million patients with a potential neck (c-spine) injury are transported to Ontario emergency departments (EDs). Less than 1.0% (1/100) of these patients have a neck bone fracture. Even less (1/200, 0.5%) have a spinal cord injury or nerve damage. Currently, paramedics transport all trauma victims (with or without an injury) by ambulance using a backboard, cervical collar, and head immobilizers. Importantly, prolonged immobilization is often unnecessary; it causes patient discomfort and pain, decreases community access to paramedics, contributes to ED crowding, and is very costly. We therefore developed the Canadian C-Spine Rule (CCR) for alert and stable trauma patients. This decision rule helps ED physicians and triage nurses to safely and selectively remove immobilization, without x-rays and missed injury. We successfully taught Ottawa paramedics to use the CCR in the field in a single-center study. OBJECTIVE: This study aimed to improve patient care and health system efficiency and outcomes by allowing paramedics to assess eligible low-risk trauma patients with the CCR and selectively transport them without immobilization to the ED. METHODS: We propose a pragmatic stepped-wedge cluster randomized design with health economic evaluation, designed collaboratively with knowledge users. Our 36-month study will consist of a 12-month setup and training period (year 1), followed by the stepped-wedge trial (year 2) and a 12-month period for study completion, analyses, and knowledge translation. A total of 12 Ontario paramedic services of various sizes distributed across the province will be randomly allocated to one of three sequences. Paramedic services in each sequence will cross from the control condition (usual care) to the intervention condition (CCR implementation) at intervals of 3 months until all communities have crossed to the intervention. Data will be collected on all eligible patients in each paramedic service for a total duration of 12 months. A major strength of our design is that each community will have implemented the CCR by the end of the study. RESULTS: Interim results are expected in December 2019 and final results in 2020. If this multicenter trial is successful, we expect the Ontario Ministry of Health will recommend that paramedics evaluate all eligible patients with the CCR in the Province of Ontario. CONCLUSIONS: We conservatively estimate that in Ontario, more than 60% of all eligible trauma patients (300,000 annually) could be transported safely and comfortably, without c-spine immobilization devices. This will significantly reduce patient pain and discomfort, paramedic intervention times, and ED length of stay, thereby improving access to paramedics and ED care. This could be achieved rapidly and with lower health care costs compared with current practices (possible cost saving of Can $36 [US $25] per immobilization or Can $10,656,000 [US $7,335,231] per year). TRIAL REGISTRATION: ClinicalTrials.gov NCT02786966; https://clinicaltrials.gov/ct2/show/NCT02786966. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/16966.

A survey of factors associated with the successful recognition of agonal breathing and cardiac arrest by 9-1-1 call takers: design and methodology.

BACKGROUND: Cardiac arrest victims most often collapse at home, where only a modest proportion receives life-saving bystander cardiopulmonary resuscitation. As many as 40% of all sudden cardiac arrest victims have agonal or abnormal breathing in the first minutes following cardiac arrest. 9-1-1 call takers may wrongly interpret agonal breathing as a sign of life, and not initiate telephone cardiopulmonary resuscitation instructions. Improving 9-1-1 call takers' ability to recognize agonal breathing as a sign of cardiac arrest could result in improved bystander cardiopulmonary resuscitation and survival rates for out-of-hospital cardiac arrest victims. METHODS/DESIGN: The overall goal of this study is to design and conduct a survey of 9-1-1 call takers in the province of Ontario to better understand the factors associated with the successful identification of cardiac arrest (including patients with agonal breathing) over the phone, and subsequent administration of cardiopulmonary resuscitation instructions to callers. This study will be conducted in three phases using the Theory of Planned Behaviour. In Phase One, we will conduct semi-structured qualitative interviews with a purposeful selection of 9-1-1 call takers from Ontario, and identify common themes and belief categories. In Phase Two, we will use the qualitative interview results to design and pilot a quantitative survey. In Phase Three, a final version of the quantitative survey will be administered via an electronic medium to all registered call takers in the province of Ontario. We will perform qualitative thematic analysis (Phase One) and regression modelling (Phases Two and Three), to determine direct and indirect relationship of behavioural constructs with intentions to provide cardiopulmonary resuscitation instructions. DISCUSSION: The results of this study will provide valuable insight into the factors associated with the successful recognition of agonal breathing and cardiac arrest by 9-1-1 call takers. This will guide future interventional studies, which may include continuing education and protocol changes, in order to help increase the number of callers appropriately receiving cardiopulmonary resuscitation instructions, and save the lives of more cardiac arrest victims.

Biochemotherapy for the treatment of metastatic malignant melanoma: a systematic review.

BACKGROUND: The incidence of malignant melanoma has increased in recent years. Current therapies for metastatic melanoma include chemotherapy and a variety of immunotherapeutic choices. With no established standard treatment option, the evaluation of biochemotherapy is warranted. METHODS: A systematic review of the literature was conducted to locate randomized controlled trials, meta-analyses, systematic reviews, and evidence-based practice guidelines published up to April 2007. RESULTS: Nine eligible randomized controlled trials were identified, including six comparing chemotherapy alone to biochemotherapy (chemotherapy combined with interleukin-2 and interferon). Response rates were significantly higher with biochemotherapy in only two trials, although when data were pooled, biochemotherapy was superior to chemotherapy on response (relative risk, 1.52; 95% confidence interval, 1.24-1.87; p<0.0001) but did not delay time to progression (Hazard ratio, 0.80; 95% confidence interval, 0.63-1.01; p=0.06). Biochemotherapy was not associated with a statistically significant survival benefit in any of the individual trials or in a pooled analysis (Hazard ratio, 0.95; 95% confidence interval, 0.78-1.17; p=0.64). Biochemotherapy is a toxic therapy, and patients are likely to experience serious hematologic, gastrointestinal, cutaneous, and constitutional toxicities, although when conducted in the correct setting, grade 3 and 4 effects appear to be manageable, and treatment-related death can be minimized. CONCLUSION: The results of available studies are inconsistent with regard to benefit (response, time-to-progression, and survival) and show consistently high toxicity rates. Therefore, biochemotherapy is not recommended for the treatment of metastatic malignant melanoma in adults.

An evaluation of 9-1-1 calls to assess the effectiveness of dispatch-assisted cardiopulmonary resuscitation (CPR) instructions: design and methodology.

BACKGROUND: Cardiac arrest is the leading cause of mortality in Canada, and the overall survival rate for out-of-hospital cardiac arrest rarely exceeds 5%. Bystander cardiopulmonary resuscitation (CPR) has been shown to increase survival for cardiac arrest victims. However, bystander CPR rates remain low in Canada, rarely exceeding 15%, despite various attempts to improve them. Dispatch-assisted CPR instructions have the potential to improve rates of bystander CPR and many Canadian urban communities now offer instructions to callers reporting a victim in cardiac arrest. Dispatch-assisted CPR instructions are recommended by the International Guidelines on Emergency Cardiovascular Care, but their ability to improve cardiac arrest survival remains unclear. METHODS/DESIGN: The overall goal of this study is to better understand the factors leading to successful dispatch-assisted CPR instructions and to ultimately save the lives of more cardiac arrest patients. The study will utilize a before-after, prospective cohort design to specifically: 1) Determine the ability of 9-1-1 dispatchers to correctly diagnose cardiac arrest; 2) Quantify the frequency and impact of perceived agonal breathing on cardiac arrest diagnosis; 3) Measure the frequency with which dispatch-assisted CPR instructions can be successfully completed; and 4) Measure the impact of dispatch-assisted CPR instructions on bystander CPR and survival rates.The study will be conducted in 19 urban communities in Ontario, Canada. All 9-1-1 calls occurring in the study communities reporting out-of-hospital cardiac arrest in victims 16 years of age or older for which resuscitation was attempted will be eligible. Information will be obtained from 9-1-1 call recordings, paramedic patient care reports, base hospital records, fire medical records and hospital medical records. Victim, caller and system characteristics will be measured in the study communities before the introduction of dispatch-assisted CPR instructions (before group), during the introduction (run-in phase), and following the introduction (after group). DISCUSSION: The study will obtain information essential to the development of clinical trials that will test a variety of educational approaches and delivery methods for telephone cardiopulmonary resuscitation instructions. This will be the first study in the world to clearly quantify the impact of dispatch-assisted CPR instructions on survival to hospital discharge for out-of-hospital cardiac arrest victims. TRIAL REGISTRATION: ClinicalTrials.gov NCT00664443.

A survey of attitudes and factors associated with successful cardiopulmonary resuscitation (CPR) knowledge transfer in an older population most likely to witness cardiac arrest: design and methodology.

BACKGROUND: Overall survival rates for out-of-hospital cardiac arrest rarely exceed 5%. While bystander cardiopulmonary resuscitation (CPR) can increase survival for cardiac arrest victims by up to four times, bystander CPR rates remain low in Canada (15%). Most cardiac arrest victims are men in their sixties, they usually collapse in their own home (85%) and the event is witnessed 50% of the time. These statistics would appear to support a strategy of targeted CPR training for an older population that is most likely to witness a cardiac arrest event. However, interest in CPR training appears to decrease with advancing age. Behaviour surrounding CPR training and performance has never been studied using well validated behavioural theories. METHODS/DESIGN: The overall goal of this study is to conduct a survey to better understand the behavioural factors influencing CPR training and performance in men and women 55 years of age and older. The study will proceed in three phases. In phase one, semi-structured qualitative interviews will be conducted and recorded to identify common categories and themes regarding seeking CPR training and providing CPR to a cardiac arrest victim. The themes identified in the first phase will be used in phase two to develop, pilot-test, and refine a survey instrument based upon the Theory of Planned Behaviour. In the third phase of the project, the final survey will be administered to a sample of the study population over the telephone. Analyses will include measures of sampling bias, reliability of the measures, construct validity, as well as multiple regression analyses to identify constructs and beliefs most salient to seniors' decisions about whether to attend CPR classes or perform CPR on a cardiac arrest victim. DISCUSSION: The results of this survey will provide valuable insight into factors influencing the interest in CPR training and performance among a targeted group of individuals most susceptible to witnessing a victim in cardiac arrest. The findings can then be applied to the design of trials of various interventions designed to promote attendance at CPR classes and improve CPR performance. TRIAL REGISTRATION: ClinicalTrials.gov NCT00665288.

Factors influencing the intentions of nurses and respiratory therapists to use automated external defibrillators during in-hospital cardiac arrest: a qualitative interview study.

OBJECTIVES: Nurses and respiratory therapists are seldom allowed to use automated external defibrillators (AED) during in-hospital cardiac arrest. This can result in significant time delays before defibrillation occurs and lower survival for cardiac arrest victims. We sought to identify barriers and facilitators to AED use by nurses and respiratory therapists. METHODS: We conducted semi-structured qualitative interviews with a purposeful sample of nurses and respiratory therapists. We developed the interview guide based on the constructs of the theory of planned behaviour, which elicits salient attitudes, social influences, and control beliefs potentially influencing the intent to use an AED. Interviews were recorded, transcribed verbatim, and analysed until achieving data saturation. Two independent reviewers performed inductive analyses to identify emerging categories and themes, and ranked them by frequency of the number of participants stating the topic. RESULTS: Demographics for the 24 interviewees include mean age 40.5, 79.2% female, 87.5% performed cardiopulmonary resuscitation (CPR), 29.2% defibrillated a patient. Identified attitudes pertained to the timeliness of defibrillation, patient survival, simplicity of AED use, accuracy of rhythm recognition, and harm to self or others. Social influences consisted of physician and hospital administration support of AED use. Control beliefs included training on AED use, policy allowing AED use, familiarity with AED, and task burden during resuscitation. CONCLUSIONS: Most nurses and respiratory therapists intended to use an AED if permitted to do so by a medical directive. Successful implementation would require educational initiatives focusing on safety and efficacy of AEDs, support from physicians and hospital administrators, and additional training on AED use.

Single-agent interleukin-2 in the treatment of metastatic melanoma: a systematic review.

BACKGROUND: The aim of this systematic review was to determine the role of single-agent interleukin-2 in the treatment of adults with metastatic melanoma. Outcomes of interest include objective and complete response rates, duration of response, toxicity and quality of life. METHODS: A systematic review of the literature was conducted to locate randomized controlled trials, meta-analyses, and systematic reviews published between 1985 and 2006. RESULTS: Data from three randomized controlled trials demonstrate that single-agent interleukin-2, when given in high-doses, elicited objective response rates of 5-27% with complete responses in 0-4% of patients. High-dose interleukin-2, administered as a single-agent or in combination with lymphokine-activated killer cells, demonstrates complete response rates ranging from 0% to 11% and has shown consistent observations of long-term responses that range from 6 to 66+ months (median 27 months). Non-comparative phase II trials of high-dose single-agent interleukin-2 have consistently reported objective response rates of 10-33% with complete response rates ranging from 0% to 15%. Complete responders in those trials also demonstrate long-term responses ranging from 1.5 to 148 months (median 70 months). No other therapy for metastatic melanoma offers the possibility for a durable complete remission. CONCLUSION: This systematic review suggests that patients with a good performance status (ECOG 0-1), a normal lactate dehydrogenase level, less than three organs involved or cutaneous and/or subcutaneous metastases, have the highest probability of responding and achieving a durable complete response. This carefully selected group of patients should be considered for treatment with high-dose interleukin-2.

Adjuvant therapy for stage II colon cancer: a systematic review from the Cancer Care Ontario Program in evidence-based care's gastrointestinal cancer disease site group.

PURPOSE: To develop a systematic review that would address the following question: Should patients with stage II colon cancer receive adjuvant therapy? METHODS: A systematic review was undertaken to locate randomized controlled trials comparing adjuvant therapy to observation. RESULTS: Thirty-seven trials and 11 meta-analyses were included. The evidence for stage II colon cancer comes primarily from a trial of fluorouracil plus levamisole and a meta-analysis of 1,016 patients comparing fluorouracil plus folinic acid versus observation. Neither detected an improvement in disease-free or overall survival for adjuvant therapy. A recent pooled analysis of data from seven trials observed a benefit for adjuvant therapy in a multivariate analysis for both disease-free and overall survival. The disease-free survival benefits appeared to extend to stage II patients; however, no P values were provided. A meta-analysis of chemotherapy by portal vein infusion has also shown a benefit in disease-free and overall survival for stage II patients. A meta-analysis was conducted using data on stage II patients where data were available (n = 4,187). The mortality risk ratio was 0.87 (95% CI, 0.75 to 1.01; P =.07). CONCLUSION: There is preliminary evidence indicating that adjuvant therapy is associated with a disease-free survival benefit for patients with stage II colon cancer. These benefits are small and not necessarily associated with improved overall survival. Patients should be made aware of these results and encouraged to participate in active clinical trials. Additional investigation of newer therapies and more mature data from the presently available trials should be pursued.

American Society of Clinical Oncology recommendations on adjuvant chemotherapy for stage II colon cancer.

PURPOSE: To address whether all medically fit patients with curatively resected stage II colon cancer should be offered adjuvant chemotherapy as part of routine clinical practice, to identify patients with poor prognosis characteristics, and to describe strategies for oncologists to use to discuss adjuvant chemotherapy in practice. METHODS: An American Society of Clinical Oncology Panel, in collaboration with the Cancer Care Ontario Practice Guideline Initiative, reviewed pertinent information from the literature through May 2003. RESULTS: A literature-based meta-analysis found no evidence of a statistically significant survival benefit of adjuvant chemotherapy for stage II patients. Recommendations The routine use of adjuvant chemotherapy for medically fit patients with stage II colon cancer is not recommended. However, there are populations of patients with stage II disease that could be considered for adjuvant therapy, including patients with inadequately sampled nodes, T4 lesions, perforation, or poorly differentiated histology. CONCLUSION: Direct evidence from randomized controlled trials does not support the routine use of adjuvant chemotherapy for patients with stage II colon cancer. Patients and oncologists who accept the relative benefit in stage III disease as adequate indirect evidence of benefit for stage II disease are justified in considering the use of adjuvant chemotherapy, particularly for those patients with high-risk stage II disease. The ultimate clinical decision should be based on discussions with the patient about the nature of the evidence supporting treatment, the anticipated morbidity of treatment, the presence of high-risk prognostic features on individual prognosis, and patient preferences. Patients with stage II disease should be encouraged to participate in randomized trials.

Radiopharmaceuticals for the palliation of painful bone metastasis-a systemic review.

BACKGROUND AND PURPOSE: The purpose was to develop a systematic review that would address the following question: what is the role of radiopharmaceuticals in the palliation of metastatic bone pain in adults with uncomplicated, multifocal painful bone metastases whose pain is not controlled with conventional analgesic regimens? The outcomes of interest are pain response, analgesic consumption, overall survival, adverse effects and quality of life. MATERIALS AND METHODS: A systematic review of the English published literature was undertaken to provide evidence relevant to the above outcomes. RESULTS: Six randomized phase III trials, two randomized phase II trials and one randomized crossover trial of strontium-89 were reviewed. A randomized phase III trial comparing strontium-89 plus cisplatin with strontium-89 plus placebo reported a significantly higher proportion of patients experiencing pain relief for a significantly longer duration with strontium-89 plus cisplatin. A randomized phase III trial comparing adjuvant strontium-89 with placebo following radiotherapy reported a higher proportion of pain-free patients with strontium-89. Patients who received strontium-89 also experienced fewer new sites of bone pain. A second, but underpowered study failed to confirm these results. In one randomized trial of strontium-89 versus radiotherapy (hemibody or local), patients treated with strontium-89 developed fewer new sites of pain. In a second trial comparing strontium-89 versus local radiotherapy, median overall survival was improved with radiotherapy, while pain response and time-to-progression were similar in the two groups. One randomized phase III trial reported no difference in pain relief between strontium-89 and placebo. Three randomized phase III trials and two randomized phase II trials investigating samarium-153 were reviewed. In a randomized phase III trial of three different doses of samarium-153, the pain responses were similar for all three doses. In a randomized phase III trial of two different doses of samarium-153 versus placebo, the complete pain response rate was significantly higher with the higher dose of samarium-153 compared with placebo. In a randomized phase III trial comparing samarium-153 with placebo, significant differences favouring samarium-153 were reported for pain and opiate use. In addition, one randomized phase III trial, two randomized phase II trials, one randomized crossover trial and 13 phase II or phase I trials of rhenium, one phase I trial of tin-117 m and one phase II trial of phosphorus-32 were reviewed. The majority of patients treated in trials of radiopharmaceuticals where histology was specified had metastatic breast cancer (approximately 5-10% of patients reported), metastatic hormone-refractory prostate cancer (80-90% of patients reported) or metastatic lung cancer (5-10% of patients reported). Information on histologic subtype was not available for a significant proportion of patients treated on trials (30-40% of patients reported). CONCLUSIONS: Use of single-agent radiopharmaceuticals (strontium-89 and samarium-153) should be considered as a possible option for the palliation of multiple sites of bone pain from metastatic cancer where pain control with conventional analgesic regimens is unsatisfactory and where activity on a bone scan of the painful lesions is demonstrated. Ongoing clinical research should seek to establish the benefit of newer radiopharmaceuticals and radiopharmaceuticals in combination with other systemic therapies.

Evaluating the role of quality assessment of primary studies in systematic reviews of cancer practice guidelines.

BACKGROUND: The purpose of this study was to evaluate the role of study quality assessment of primary studies in cancer practice guidelines. METHODS: Reliable and valid study quality assessment scales were sought and applied to published reports of trials included in systematic reviews of cancer guidelines. Sensitivity analyses were performed to evaluate the relationship between quality scores and pooled odds ratios (OR) for mortality and need for blood transfusion. RESULTS: Results found that that whether trials were classified as high or low quality depended on the scale used to assess them. Although the results of the sensitivity analyses found some variation in the ORs observed, the confidence intervals (CIs) of the pooled effects from each of the analyses of high quality trials overlapped with the CI of the pooled odds of all trials. Quality score was not predictive of pooled ORs studied here. CONCLUSIONS: Had sensitivity analyses based on study quality been conducted prospectively, it is highly unlikely that different conclusions would have been found or that different clinical recommendations would have emerged in the guidelines.