Clinical Research Assistants Research Articles

Regional Professionals Network to Support the Renal Epidemiology and Information Registry in Ile-de-France.

We present the regional professional network to support the Renal Epidemiology Information Network (REIN) registry in maintaining high quality data production and information analyses in Ile-De-France region. The network is based on a long term partnership between the nephrologists and a regional methodology support unit. It integrates clinical research assistants for data quality control. We also present organizational methods on maintaining the registry and enhancing information analyses and automating analyses reports.

Using Stakeholder Engagement to Overcome Barriers to Implementing Patient-reported Outcomes (PROs) in Cancer Care Delivery: Approaches From 3 Prospective Studies.

Patient-reported outcome (PRO) measures used during cancer care delivery improve communication about symptoms between patients and clinicians and reduce service utilization for uncontrolled symptoms. However, uptake of PROs in routine cancer care has been slow. In this paper, we describe stakeholder engagement activities used to overcome barriers to implementing PROs. Implementation occurred in 2 study settings: PROs completed in the waiting room and reviewed during clinical visits to guide symptom management for multiple myeloma (visit-based PROs); and weekly PROs completed by cancer patients between chemotherapy visits to monitor symptoms at home (remote PROs). PRO implementation steps across studies included: (1) clinician and patient input on key symptoms, PRO measures, and identifying which PRO responses are clinically concerning to better target nursing actions; (2) developing PRO-based clinical decision support (CDS) for responding to concerning PROs; (3) training clinicians and clinical research assistants to interpret PROs and use software; and (4) describing implementation impact (frequency of concerning PRO responses and nursing actions). Clinician and patient input was critical for identifying key symptoms, PRO measures, and clinically concerning response options. For the visit-based PRO observational study, all symptom scores appeared on a clinician dashboard, and those rated ≥1 by patients (on a 0-4 or 0-10 scale) had PRO-based CDS available for access. For the 2 remote PROs trials, stakeholders recommended that the 2 "worst" response options (eg, PRO responses of "often"/"always" or "severe"/"very severe") would trigger an automated email alert to a nurse along with PRO-based CDS. In each study, PRO-based CDS was tailored based on clinician input. Across studies, the most common nursing response to concerning PROs was counseling patients on (or providing care plans for) self-management of symptoms. In the trials, the percentage of weekly remote PROs generating an alert to a nurse ranged from 13% at an academic center to 36% in community oncology practices. Across 3 prospective studies, PROs implemented into cancer care enabled tailored care based on issues identified on PROs. Stakeholder engagement was critical for successful implementation. This paper assists in addressing important PRO implementation challenges by describing a stakeholder-driven approach.

Evaluation of the approaches and knowledge level of tuberculosis diagnosis and treatment of infectious disease research assistants and specialist physicians

This study aims to evaluate approaches and knowledge level for tuberculosis (TB) diagnosis and treatment among infectious diseases and clinical microbiology research assistants and specialist physicians. This was a descriptive study on the research assistants and specialist physicians. A questionnaire consisting of 24 questions prepared by the researchers was used. Data were analyzed using SPSS, version 22.0. In this study, 116 physicians participated. The average age of participants was 41.07 ± 8.65 years, and 64.7% were female. The proportion of physicians with no pulmonary and non-pulmonary TB experience was calculated as 6.9% and 3.4%, respectively. Acid-fast-bacilli (AFB) tests were most frequently used in the diagnosis of pulmonary TB. On the other hand, the tuberculin skin test (TST) + chest radiography (CR) was most frequently used for latent TB in immunosuppressed subjects (91.4% and 69%, respectively). The most common non-pulmonary TB clinic form encountered was lymphadenitis (88.8%); the most common treatment problem was drug side effects (75%); and the most common drug resistance was to isoniazid (25.9%). It was determined that physicians encountered HIV and TB coinfection in 62.9% of patients, and standard TB treatment was applied for most patients (48.3%). The most frequent yearly TST + CR + AFB trials (69%) were performed in the screenings of health workers who were in contact with TB patients. It was observed that 44% of physicians used a negative pressurized chamber and/or isolation chamber in the institution, and 72.4% used a N95/FFP3 mask during examination. It was determined that the participants were mostly correct about TB. Infectious diseases and clinical microbiology physicians continue to encounter TB patients. This group of physicians often has a good level of knowledge and experience with TB, although special training for this disease is low.

Clinical Assessment and Diagnosis of Germline Predisposition to Hematopoietic Malignancies: The University of Chicago Experience.

With the increasing use of clinical genomics to guide cancer treatment and management, there is a rise in the identification of germline cancer predisposition syndromes and a critical need for patients with germline findings to be referred for surveillance and care. The University of Chicago Hematopoietic Malignancies Cancer Risk Team has established a unique approach to patient care for individuals with hereditary hematologic malignancies through close communication and coordination between our pediatric and adult programs. Dedicated program members, including physicians, nurses, genetic counselors, and clinical research assistants, screen individuals for cancer predisposition at initial diagnosis through survivorship, in addition to testing individuals with an established family history of a cancer predisposition syndrome. Sample procurement, such as a skin biopsy at the time of bone marrow aspirate/biopsy in individuals with a positive screen, has facilitated timely identification of clinical germline findings or has served as a pipeline for translational research. Our integrated translational research program has led to the identification of novel syndromes in collaboration with other investigators, which have been incorporated iteratively into our clinical pipeline. Individuals are referred for clinical assessment based on personal and family history, identification of variants in susceptibility genes via molecular tumor testing, and during evaluation for matched related allogeneic stem cell transplantation. Upon referral, genetic counseling incorporates education with mindfulness of the psychosocial issues surrounding germline testing at different ages. The training and role of genetic counselors continues to grow, with the discovery of new predisposition syndromes, in the age of improved molecular diagnostics and new models for service delivery, such as telemedicine. With the identification of new syndromes that may predispose individuals to hematologic malignancies, surveillance guidelines will continue to evolve and may differ between children and adults. Thus, utilizing a collaborative approach between the pediatric and adult oncology programs facilitates care within families and optimizes the diagnosis and care of individuals with cancer predisposition syndromes.

Using a Medical Intranet of Things System to Prevent Bed Falls in an Acute Care Hospital: A Pilot Study

BackgroundHospitalized patients in the United States experience falls at a rate of 2.6 to 17.1 per 1000 patient-days, with the majority occurring when a patient is moving to, from, and around the bed. Each fall with injury costs an average of US $14,000.ObjectiveThe aim was to conduct a technology evaluation, including feasibility, usability, and user experience, of a medical sensor-based Intranet of things (IoT) system in facilitating nursing response to bed exits in an acute care hospital.MethodsPatients 18 years and older with a Morse fall score of 45 or greater were recruited from a 35-bed medical-surgical ward in a 317-bed Massachusetts teaching hospital. Eligible patients were recruited between August 4, 2015 and July 31, 2016. Participants received a sensor pad placed between the top of their mattress and bed sheet. The sensor pad was positioned to monitor movement from patients’ shoulders to their thighs. The SensableCare System was evaluated for monitoring patient movement and delivering timely alerts to nursing staff via mobile devices when there appeared to be a bed-exit attempt. Sensor pad data were collected automatically from the system. The primary outcomes included number of falls, time to turn off bed-exit alerts, and the number of attempted bed-exit events. Data on patient falls were collected by clinical research assistants and confirmed with the unit nurse manager. Explanatory variables included room locations (zones 1-3), day of the week, nursing shift, and Morse Fall Scale (ie, positive fall history, positive secondary diagnosis, positive ambulatory aid, weak impaired gait/transfer, positive IV/saline lock, mentally forgets limitations). We also assessed user experience via nurse focus groups. Qualitative data regarding staff interactions with the system were collected during two focus groups with 25 total nurses, each lasting approximately 1.5 hours.ResultsA total of 91 patients used the system for 234.0 patient-days and experienced no bed falls during the study period. On average, patients were assisted/returned to bed 46 seconds after the alert system was triggered. Response times were longer during the overnight nursing shift versus day shift (P=.005), but were independent of the patient’s location on the unit. Focus groups revealed that nurses found the system integrated well into the clinical nursing workflow and the alerts were helpful in patient monitoring.ConclusionsA medical IoT system can be integrated into the existing nursing workflow and may reduce patient bed fall risk in acute care hospitals, a high priority but an elusive patient safety challenge. By using an alerting system that sends notifications directly to nurses’ mobile devices, nurses can equally respond to unassisted bed-exit attempts wherever patients are located on the ward. Further study, including a fully powered randomized controlled trial, is needed to assess effectiveness across hospital settings.

Performance of the 20-minute whole blood clotting test in detecting venom induced consumption coagulopathy from Russell's viper (Daboia russelii) bites.

The 20-minute whole blood clotting test (WBCT20) is used as a bedside diagnostic test for coagulopathic snake envenoming. We aimed to assess the performance of the WBCT20 in diagnosis of venom induced consumption coagulopathy (VICC) in Russell's viper envenoming. Adult patients admitted with suspected snake bites were recruited from two hospitals. WBCT20 and prothrombin time (PT) test were performed on admission. WBCT20 was done by trained clinical research assistants using 1 ml whole blood in a 5 ml borosilicate glass tube with a 10 mm internal diameter. The PT was measured by a semi-automated coagulation system and international normalised ratio (INR) calculated. VICC was defined as present if the INR was >1.4. The diagnostic utility of WBCT20 was determined by calculating the sensitivity and specificity of the WBCT20 on admission for detecting VICC. There were 987 snake bites where both WBCT20 and PT were done on admission samples. This included 79 patients (8 %) with VICC. The WBCT20 was positive in 65/79 patients with VICC (sensitivity 82 %; 95 % confidence interval [CI]: 72-90 %) and was falsely positive in 13/908 with no coagulopathy. The WBCT20 was negative in 895/908 snake bites with no coagulopathy (specificity: 98 % 95 % CI: 97-99 %) and was falsely negative in 14/79 with VICC. Using trained clinical staff, the WBCT20 test had a relatively good sensitivity for the detection of VICC, but still missed almost one fifth of cases where antivenom was potentially indicated.

The Non-Dialysis Chronic Renal Insufficiency study (ND-CRIS): an open prospective hospital-based cohort study in France.

BackgroundChronic kidney disease (CKD) amounts to a heavy burden for health services. There is no long-running epidemiological tool for CKD before dialysis. We here present the protocol for a cohort of patients with “non-dialysis” CKD receiving care in the Bourgogne-Franche-Comté region of France. The aim of this cohort was to periodically describe the characteristics of patients included and their care provision, to analyse evolution in care and patients’ kidney function outcomes.MethodsThe ND-CRIS cohort is prevalent and incident. Patients are included in the cohort if over 18, with a glomerula filtration rate (GFR) <60 ml/min/1.73 m2, non-dialysed, informed on the research and not having opposed it, and followed by a nephrologist in one of the 9 centres in the region, (3 pilot centres joined by 6 others in 2015). All the patients are followed up, with varying time lapses according to the degree of GFR deterioration. Data is collected by clinical research assistants (CRAs) using a dedicated computerised case-report form (CRF). Professional practices are assessed using indicators defined by the French Health Authority. The follow-up of patients included should enable assessment of the evolution of their GFR and co-morbidities. The periodic descriptions should give insight into evolution in epidemiological terms.DiscussionThe ND-CRIS meets a need in epidemiological tools in France for CKD. The cohort does claim to be representative, of ND-CKD patients receiving care from nephrologists. The open and incident nature of the cohort and the number of patients included in the ND-CRIS should provide answers to questions that cannot be answered by smaller solely prevalent cohorts. The numbers of patients included over the study period (2391 patients in 3 centres in 3 years) suggests that the figure of 5000 patients should be reached by 2017. The participation of nephrologists and the rate of inclusions point to the feasibility of the implementation of this cohort. Beyond the information to be found in the CRFs, this cohort should also enable ad hoc studies, in particular in the area of pharmaco-epidemiology, and it could later serve as a research platform and as a public health surveillance tool.

P062: Impact of pharmacist-led medication review in the emergency department on downstream health services utilization

Introduction: Adverse drug events are a leading cause of Emergency Department (ED) visits and unplanned admissions. Up to 50% are misdiagnosed in the ED and on hospital wards leading to treatment delays. Our main objective was to evaluate the effect of pharmacist-led medication review in high-risk ED patients on the number of days in-hospital. Our hypothesis was that early pharmacist-led medication review may reduce the number of days spent in-hospital. Methods: We evaluated a quality improvement program that was implemented in three British Columbian EDs. During a 12-month period, nurses identified consecutive patients at high-risk for adverse drug events using a clinical decision rule integrated into triage algorithms. Clinical pharmacist research assistants enrolled consecutive eligible high-risk patients, and systematically allocated them to medication review or control. In the intervention group, pharmacists collected best possible medication histories, reviewed medications for appropriateness and adverse drug events, and communicated review results to patients and physicians. In the control group, nurses collected best-possible medication histories, and physicians referred patients to the ED pharmacist as needed. Ongoing care was determined by physicians who were not blinded to group allocation, but were unaware of the evaluation. We assessed outcomes using administrative health databases. The primary outcome was the number of days spent in-hospital over 30 days. We used inverse propensity score weighted regression modeling to assess the relationship between medication review and health outcomes. The sample size was limited by the duration of the quality improvement program. Results: Among 10,807 patients 6,416 received medication review in the ED and 4,391 usual care. The groups were balanced in terms of baseline characteristics. The median number of hospital days was 0.48 days (95% confidence interval [CI] 0.00-0.96) less in the medication review group compared to usual care (p=0.058). The difference was 0.60 days (95% CI 0.06-1.17; p=0.03) less among patients under 80 years old. There was no effect on ED revisits, number of admissions and readmissions, or mortality. Conclusion: Medication review was associated with a trend in reduced hospital-bed utilization. While limited by lack of randomization, our evaluation suggests that ED pharmacists may impact subsequent resource utilization.

Early results from a multi-component French public-private partnership initiative to improve participation in clinical research - CeNGEPS: a prospective before-after study.

BackgroundA public-private (51/49 %) partnership was initiated in 2007 in France to improve the attractiveness of French sites in industry-sponsored international clinical trials. This initiative developed and implemented a combination of structuring actions and support actions. Here we report the assessment of the impact after 6 years on participation of French study sites in industry-sponsored clinical trials.MethodsWe performed a prospective before-after study of clinical research activities in French public hospitals to assess the impact of actions developed and implemented by CeNGEPS. The programme involved a combination of structuring actions (establishment of sites of excellence, national networks and dedicated clinical research assistants (CRAs)), support actions (tools, templates and training) and competitive budget allocation for sites or networks based on performance. The impact was assessed using the following performance criteria: 1) reduction of the delay to contract signature to ≤ 60 days for 80 % of the trial sites; 2) inclusion of ≥80 % of the planned number of patients by at least 80 % of trial sites; 3) closure of <15 % of trials sites without patients enrolled.ResultsIn 2013, the median delay to contract signature was: 55 days, compared with 76 days in 2008 (27.6 % reduction), 50.5 % of all sites and 58 % of sites with a dedicated CRA included ≥80 % of the planned number of patients compared with 44.8 % in 2008 (12.7 % increase) and 21.3 % of all sites and 9 % of sites with a dedicated CRA closed with no patients included, compared with 26.4 % in 2008 (19.3 and 65.9 %, respectively).ConclusionsThese results provide evidence that it is possible to improve a country’s attractiveness for industry-sponsored clinical research. The two main actions, i.e. establishing sites of excellence throughout the country with well-trained, dedicated staff and establishing a national network of clinical investigators, could be adapted to other countries in Western Europe to improve Europe’s attractiveness to industry-funded trials.

Correlation between tea consumption and prevalence of hypertension among Singaporean Chinese residents aged ⩾40 years

By a cross-sectional epidemiology study, we attempted to correlate the consumption of tea and/or health supplements, living habits and socio-demographic factors to the prevalence of hypertension among Singaporean Chinese residents. Singaporean Chinese residents aged ⩾40 years were randomly selected and interviewed face-to-face by clinical research assistants. Hypertension was defined as measured systolic blood pressure at least 140 mm Hg and/or diastolic blood pressure at least 90 mmHg or self-reported history/treatment for hypertension. The prevalence of hypertension among the whole investigated population (N=1184, 58.27% females) was 49.73% and the prevalence increased to 66.47% in the sub-population aged ⩾60 years. High risk of hypertension was associated with age ⩾60 years (odds ratio (OR): 4.15-4.19, P<0.01), obesity (body mass index >25 kg m(-2), OR: 2.10-2.11, P<0.01), family history of hypertension (OR: 2.69-2.76, P<0.01), diabetes history (OR: 2.29-2.33, P<0.01), hyperlipidemia history (OR: 1.79-1.80, P<0.01), male (OR: 1.56-1.59, P<0.01) and coffee intake (OR: 1.44-1.46, P<0.05). In contrast, drinking green tea at least 150 ml per week was associated with lower hypertension risk (OR: 0.63, 95% confidence interval (CI): 0.43-0.91, P<0.05). Drinking combination of green tea and British tea was associated with higher reduction in the risk of hypertension (OR: 0.58, 95% CI: 0.39-0.85, P<0.05). This cross-sectional study suggests that consumption of tea, especially green tea and British tea, was associated with lowering the risk of hypertension. On the other hand, consumption of coffee could be a risk factor of hypertension. These findings may provide useful information for health promotion to reduce risk of hypertension and warrant further study to confirm and elucidate such association.

High Response Rate and Low Toxicity of Rituximab, Vinorelbine, Ifosfamide, Mitoxantrone and Prednisone Combination for the Treatment of Diffuse Large B Cell Lymphoma In First Relapse: Early Results of the R-NIMP GOELAMS Study.

AbstractAbstract 2796 Background:Diffuse large B-cell lymphoma (DLBCL) relapse prognosis is poor, and the optimal salvage treatment is not known. In a previous pilot study, vinorelbine, ifosfamide, mitoxantrone, and prednisone (NIMP) without rituximab has shown a promising efficacy in the setting of relapsed DLBCL. Aims:To evaluate the efficacy and tolerability of the combination of rituximab and NIMP in the treatment of DLBCL in first relapse. Methods:This multicentric, single-arm phase II study included patients 18 to 75 years old, with CD20-positive DLBCL in first relapse (defined as having obtained at least a PR of more than 50% to an anthracycline-based front-line regimen) occurring more than 30 days after the last chemotherapy cycle or more than one year after an autologous stem cell transplantation (ASCT) in first line. Other inclusion criteria were a performance status ≤ 2, absence of CNS involvement, and having signed an informed consent form. Patients with evidence of transformation from indolent lymphoma, primary refractory disease, or positive HIV tests were excluded. Initial and relapse biopsies were centrally reviewed. Patients received intravenous (IV) rituximab 375 mg/m2 D1, ifosfamide 1000 mg/m2 as a continuous infusion from D1 to D5, IV vinorelbine 25 mg/m2 D1 and D15, IV mitoxantrone 10 mg/m2 D1, and oral prednisone 1 mg/kg D1 to D5, repeated every 28 days for three cycles. Pegfilgrastim support (6 mg at D7) was recommended. The primary endpoint was CR/CRu after 3 cycles, and was assessed by computed tomography according to the IWG criteria. Mobilization, consolidation or subsequent salvage therapy was decided at the discretion of the investigator. All the monitoring and data management were performed by the GOELAMS clinical research assistants, with a database lock on July 27, 2010. Results:Fifty patients (21[42%] women and 29[58%] men) were included in 18 centers between December 2004 and accrual closure in April 2010. All patients received at least 1 cycle of R-NIMP. Forty-five patients were available for central pathology review, toxicity and response. The central review of all patient samples confirmed DLBCL histology. Median age at study entry was 62.9 years (range: 34.8–75.6). Median time between first diagnosis of DLBCL and relapse was 18.0 months (range: 2.4–208). The following tumor responses were observed: 67.9 % overall response rate with 20 CR/CRu (43.5%), 11 PR (24.4%), 2 SD (4.4%), and 12 (26.7%) progressed under therapy. Toxicity information was available for 109/120 (91 %) of the first 3 cycles of R-NIMP administered. The following toxicities were observed (all grades, ≥ grade 3 for all cycles): anemia (87%, 8%), neutropenia (66%; 46%), thrombopenia (65%, 14%), elevated liver tests (39%, 0%), constipation (25%, 0%), kidney failure (7%, 0%), nausea (14%, 0%), vomiting (6%, 0%), allergic reactions (5%, 0%), and mucositis (5%, 0%). Twenty-nine infectious events (27%) were observed needing hospitalization in 9 cases. Twenty-nine patients received consolidation therapy at the discretion of the investigator. Of the 11 patients who received 3 additional cycles of R-NIMP, 3 remained in CR/CRu, 1 remained in PR, 4 converted from PR to CR/CRu, and 3 progressed. Among the 11 patients who underwent ASCT, 9 were in CR at the end of the procedure, one patient died of toxicity and 1 progressed. For the 12 patients mobilized after a R-NIMP cycle, a median of 1 apheresis (range 1–4) was necessary to harvest a median of 3.85 × 106 CD34+ cells/kg. The median time to second progression or relapse (TTP2) was 11.4 months, and the median survival of 55.5 months. On multivariate analysis, the variable associated with a longer TTP2 was the achievement of CR/Cru (RR: 0,12; CI95%: 0.03–0,39; p=0.0006). Within the subgroup of patients having received a consolidation treatment, having received an ASCT was associated with a longer TTP2 (RR: 0.20; CI95%: 0.04–0.98; p=0.047). Time to first relapse or previous rituximab exposure did not affect TTP2 nor OS, whereas relapse-IPI (as a continuous variable, by 1 additional risk factor) was associated with a poor survival (RR: 2.59; CI95%: 1.25–4.45; p=0.008). Conclusions:R-NIMP is a well-tolerated regimen, yields a high complete response rate, and allows for successful mobilization of CD34+ cells. This regimen is a suitable salvage treatment for relapsed DLBCL prior to appropriate consolidation. Further investigation is warranted. ClinicalTrials.gov number: NCT00842595 Disclosures:Off Label Use: Vinorelbine in Non-Hodgkin's Lymphoma (Off-label in France).

Suitability of three indicators measuring the quality of coordination within hospitals

BackgroundCoordination within hospitals is a major attribute of medical care and influences quality of care. This study tested the validity of 3 indicators covering two key aspects of coordination: the transfer of written information between professionals (medical record content, radiology exam order) and the holding of multidisciplinary team meetings during treatment planning.MethodsThe study was supervised by the French health authorities (COMPAQH project). Data for the three indicators were collected in a panel of 30 to 60 volunteer hospitals by 6 Clinical Research Assistants. The metrological qualities of the indicators were assessed: (i) Feasibility was assessed using a grid of 19 potential problems, (ii) Inter-observer reliability was given by the kappa coefficient () and internal consistency by Cronbach's alpha test, (iii) Discriminatory power was given by an analysis of inter-hospital variability using the Gini coefficient as a measure of dispersion.ResultsOverall, 19281 data items were collected and analyzed. All three indicators presented acceptable feasibility and reliability (, 0.59 to 0.97) and showed wide differences among hospitals (Gini, 0.08 to 0.11), indicating that they are suitable for making comparisons among hospitals.ConclusionThis set of 3 indicators provides a proxy measurement of coordination. Further research on the indicators is needed to find out how they can generate a learning process. The medical record indicator has been included in the French national accreditation procedure for healthcare organisations. The two other indicators are currently being assessed for inclusion.

How to limit the burden of data collection for Quality Indicators based on medical records? The COMPAQH experience

BackgroundOur objective was to limit the burden of data collection for Quality Indicators (QIs) based on medical records.MethodsThe study was supervised by the COMPAQH project. Four QIs based on medical records were tested: medical record conformity; traceability of pain assessment; screening for nutritional disorders; time elapsed before sending copy of discharge letter to the general practitioner. Data were collected by 6 Clinical Research Assistants (CRAs) in a panel of 36 volunteer hospitals and analyzed by COMPAQH. To limit the burden of data collection, we used the same sample of medical records for all 4 QIs, limited sample size to 80 medical records, and built a composite score of only 10 items to assess medical record completeness. We assessed QI feasibility by completing a grid of 19 potential problems and evaluating time spent. We assessed reliability (κ coefficient) as well as internal consistency (Cronbach α coefficient) in an inter-observer study, and discriminatory power by analysing QI variability among hospitals.ResultsOverall, 23 115 data items were collected for the 4 QIs and analyzed. The average time spent on data collection was 8.5 days per hospital. The most common feasibility problem was misunderstanding of the item by hospital staff. QI reliability was good (κ: 0.59–0.97 according to QI). The hospitals differed widely in their ability to meet the quality criteria (mean value: 19–85%).ConclusionThese 4 QIs based on medical records can be used to compare the quality of record keeping among hospitals while limiting the burden of data collection, and can therefore be used for benchmarking purposes. The French National Health Directorate has included them in the new 2009 version of the accreditation procedure for healthcare organizations.

L’organisation de la recherche clinique en France : les nouvelles missions des délégations inter-régionales à la recherche clinique

The organisation of clinical research in French teaching hospitals has been profoundly modified over the past 15 years. The first call for clinical research projects was made by the Ministry of Health in 1993. This Hospital Program for Clinical Research was created by the public welfare system, a situation unique in Europe and the USA at the time. Every year since 1993, new clinical research projects have been supported through this program. In 2007, more than 14 million euros was provided for clinical research in oncology more than 21 million euros for clinical research in other fields, and more than 11 million euros through interregional grants. Overall, more than 50 million euros will be provided in 2008 to support clinical research with public sponsorship in French teaching hospitals. Major organisational changes were made to support this unprecedented financial effort in favor of clinical research. In each of the 29 French teaching hospitals, a Delegation for Clinical Research (DRC) was created to promote public sponsorship of clinical trials, to monitor these trials, to guarantee that Good Clinical Practices are respected, and to control the financial aspects of research projects. Clinical Research Assistants were recruited by DRC to monitor clinical trials. Clinical Investigation Centers (CIC) were organized in conjunction with teaching hospitals and with the French biomedical research council (INSERM). Today, there are 54 CICs located in 23 teaching hospitals, conducting clinical trials and other research in epidemiology and biotechnology. In May 2005, seven interregional delegations for clinical research (DIRC) were created to coordinate these activities on a regional basis. The aim was to improve scientific collaboration between teaching hospitals in a given region, to organize the training of clinical investigators and technicians, and to support the development of clinical trial monitoring, quality assurance, and pharmacovigilance. A 2006 survey of clinical trials sponsored by the drug industry in France showed that, by comparison to 2004, the number of patients enrolled had fallen. The mean rate of enrolments per investigator was lower than the European average (1.4 patients per month versus 1.7 in Europe as a whole), and the time necessary to organize hospital-based clinical trials was excessive (140 days). Given the globalisation of clinical trials and the increasing competition among countries, these weaknesses could have had deleterious consequences for French investigators and patients. Thus, in 2007, a joint public-private working party created a public interest group called CENGEPS (Centre national de gestion des essais des produits de santé) to provide financial support for DIRC (10 million euros per year for 4 years), derived from a special tax on drugs industry revenue. The objectives were to promote the development of clinical trials of drugs with industrial sponsors in France, to help clinical investigators to participate in these trials, and to increase the patient accrual rate. After a call for projects from each DIRC, grants were distributed to regional offices charged with managing relations with drug companies. Funds were also provided for the recruitment of 150 clinical trial technicians responsible for speeding patient enrolment and for providing clinicians with logistic backup for patient follow-up. National networks of clinical investigators will be created to develop clinical trials in fields such as Alzheimer's disease, other mental illnesses, pediatric drugs, vaccines, AIDS, thromboembolism, etc. Thus, over the last 15 years, the organization of clinical research in France has been completely overhauled. The creation of DIRC will boost interregional cooperation among teaching hospitals and increase the number of clinical trials with both public and private sponsorship. Quality and efficiency will be improved by the increased professionalism of all those involved in clinical trials.

Smiles and Tears

ABSTRACTBackground: Admission into medical schools or other health-related professional schools has become increasingly competitive. As a result, many undergraduate students aspiring to become health care professionals volunteer or work in a health care setting to better equip themselves for the challenge. While there have been a number of papers written about the experiences of medical and nursing students, there is limited amount of literature regarding the experience of undergraduate students in clinical practice environments. Insight into their perspectives and roles could promote patient care and research.Goal: The purpose of the present qualitative study was to explore and describe the experience of being a clinical research student in an outpatient palliative radiotherapy clinic.Methods: Students who have worked as clinical research assistants at the palliative radiotherapy clinic were first asked to write responses to two open ended questions that were qualitatively analyzed for general themes. Su...

Baseline results of the Depiscan study: A French randomized pilot trial of lung cancer screening comparing low dose CT scan (LDCT) and chest X-ray (CXR)

Lung cancer has the highest mortality-rate per cancer, with an overall 5-year survival <15%. Several non-randomized studies pointed out the high sensitivity of low dose computed tomography (LDCT) to detect early stage lung cancer. In France, Depiscan, a pilot RCT of LDCT versus chest X-ray (CXR), started on October 2002 to determine the feasibility of enrollment by general practitioners (GPs), investigations and diagnostic procedures by university hospital radiologists and multidisciplinary teams, data management by centralized clinical research assistants, and anticipate the future management of a large national trial. GPs and occupational physicians (OPs) selected and enrolled 1000 subjects in 1 year. Eligible subjects were asymptomatic males or females aged 50-75 years with a current or former cigarette smoking history of >/=15 cigarettes per day for at least 20 years (former smokers having quit <15 years prior to enrollment). Based to randomization, annual LDCT or CXR screenings were planned at baseline and annually for 2 years. Between October 2002 and December 2004, 765 subjects were enrolled by 89 out of the 232 participating GPs and OPs. Complete clinical and imaging baseline data were available for 621 individuals out of the 765 enrolled, due to 144 noncompliant subjects who withdrew their consent. At least one nodule was detected in 152 out of 336 subjects (45.2%) in the LDCT screening, versus 21 out of 285 subjects (7.4%) in the CXR screening arm. Eight lung cancers were detected in the LDCT arm and one in the CXR arm. This pilot trial allows estimating that non-calcified nodules are 10 [6.36-17.07] times more often detected from LDCT than from CXR. However enrollment by GPs was more difficult than expected with 41% active investigators and a high rate (19%) of noncompliant patients. This experience speaks to the need for a high level of GPs formation and a large, coordinated clinical research team in such a trial. 02526.

Apathy in Dementia: An Examination of the Psychometric Properties of the Apathy Evaluation Scale

Apathy in Dementia: An Examination of the Psychometric Properties of the Apathy Evaluation Scale

Smiles and Tears

Background: Admission into medical schools or other health-related professional schools has become increasingly competitive. As a result, many undergraduate students aspiring to become health care professionals volunteer or work in a health care setting to better equip themselves for the challenge. While there have been a number of papers written about the experiences of medical and nursing students, there is limited amount of literature regarding the experience of undergraduate students in clinical practice environments. Insight into their perspectives and roles could promote patient care and research.Goal: The purpose of the present qualitative study was to explore and describe the experience of being a clinical research student in an outpatient palliative radiotherapy clinic.Methods: Students who have worked as clinical research assistants at the palliative radiotherapy clinic were first asked to write responses to two open ended questions that were qualitatively analyzed for general themes. Su...

LAMP. A data management and analysis system for patient registries and clinical studies.

A computer system for the management and analysis of clinical data is described. The system is implemented in the ANSI standard MUMPS language and runs on popular minicomputers. The system is designed to allow clinical investigators or research assistants to define a data base, enter and edit data, produce patient-specific reports, and perform a variety of analyses on user-specified groups of subjects. Programmer intervention is not required at any stage of the management or analysis process, and on-line documentation provides a friendly environment for inexperienced users.