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P26 Monitoring in a large multicentre international clinical trial: The italian experience in core study
106s
Abstracts
P25 REPRESENTATIVENESS OF CLINICAL TRIAL PARTICIPANTS; THE HEMODIALYSIS STUDY John W. Kusek, Gerald J. Beck, Garabed Eknoyan, Andrew S. Levey, Nathan W. Levin, Daniel B. Ornt, William F. Owen, Gerald Schuhnan and Camille A. Jones from the Hemodiilysis (HEMO) Study National Institutes of Health Bethesda, Maryland Clinical trial results are most useful if the participants are generally representative with respect to the most important prognostic covariates of the general patient population which might be affected by the Bndmgs of the trial. To determine the generaliability of the Hemodiilysis (HEMO) Study, a 2 by 2 factorial randomized clinical trial of treatments impacting adequacy of hemodialysis (HD), a sample of 1170 prevalent HD patients in 15 HEM0 CIinical Centers was surveyed. Characteristics of the randomized participants (n = 353 as of November 1995) were compared to surveyed prevalent HD patients and to HD patients identified by the United States Renal Data System (USRDS), a national database that includes over 90% of the treated end-stage renal disease (ESRD) patients in the U.S. Compared to the prevalent HD patients in the centers, the HEM0 Study participants were similar with respect to mean age (58 vs 57 years), gender (48.8% vs 50.4% women) and the presence of non-insulin dependent diabetes (18.9% vs 21.0%). HEM0 Study participants were less likely to have insulin-dependent diabetes (15.9% vs 23.4%), a history of ischemic heart disease (IHD) (26.9% vs 34.7%) and/or congestive heart failure (CHF) (23.5% vs 31.8%) than prevalent HD patients. HEM0 Study participants were simiir to USRDS HD patients (using similar age range for HEM0 Study entry 18 to 80 years) with respect to mean age (57 yrs vs 57.9 yrs) gender (50.4% vs 48.0% women), and the two most frequent causes of USRD (32.9% vs 28.9% for hypertensive nephrosclerosis, 31.4% vs 32.0% for diabetes). Of patients enrolled in the HEM0 Study, a greater proportion (64.9%) are African American than in the USRDS HI) patient population (39.8%) in 1992. We conclude that randomized HEM0 Study participants to date (the trial will ultimately ‘randomize 1600-1700 patients) are generally representative of surveyed HD patients found in HD units from which they are recruited but include a higher proportion of African Americans than the general U.S. HD patient population, and a lesser proportion with IHD and CHF. P26 MONITORING IN A LARGE MULTICENTRE INTERNATIONAL CLINICAL TRIAL: THE ITALIAN EXPERIENCE IN CORE STUDY E. Bonfanti, E. Gardinale, M.G. Franzosi on behalf of GISSI Investigators ANMCO and Istituto “‘MariaNegri” Milano, Itiy The Collaborative Organization for RheothRx Evaluation (CORE) pilot study evaluated RheothRx in 2948 patients (pts) with Acute Myocardial Infarction (AMI) enrolled by a large number of Coronary Care Units spread aII over the world, foIIowing Good CIinical Practices (GCPs) as required by the Food and Drug Administration (FDA).
107s
Abstracts
Monitoring of the participating centres emerged as one of the main issue, considering the heterogeneity existing among the countries. In Italy monitoring was carried out by the GISSI-Coordinating Centre (CC), which identified some senior cardiologists as monitors of one or two centres each. They were trained by the CC following the Standard Operating Procedures (SOP)s of the study. Monitors had to visit periodically each centre in order to verify the cent& facilities prior the authorization to randomize, and to check the data reported in the study Case Report Forms against source documents (100% of data for the first 3 patients; inclusion, exclusion criteria and a11clinical outcome events for all patients). The presentation will deal with some still open issues of monitoring in clinical trials: . . .
to what extent does auditing allow the identification of errors and fraud; how much on-site record auditing should be performed; what kind of background (clinical or regulatory) is more appropriate to the role of monitor. P27 PREDICTORS OF MISSED FOLLOW-UP INTERVIEWS IN A STUDY OF ASTHMA AMONG INNER-CITY CHILDREN Shaheen U. Islam, Elizabeth C. Wright and Herman E. Mitchell for the NIAID/NIH National Cooperative Inner-City Asthma Study (NCICAS) New England Research Institutes Watertown, Massachuselts
The NCICAS recruited 1528, 4 to 9 year old children from emergency departments and clinics in eight asthma research sites in major cities to evaluate the factors that contribute to asthma morbidity. All study participants completed an extensive baseline interview including demographics, medical history, psychological status, adherence, access to care, spirometry and allergen test. By telephone interview with the caretaker, follow-up information regarding the child’s symptoms and utilization was obtained at 3, 6 and 9 months following the completion of the baseline visit. Of those who completed baseline, 8.9%, 7.7% and 5.4% missed the 3,6 and 9 month followup interviews, respectively. One or more interviews were missed by 13.9%, two or more by 5.5%, and all three follow-up interviews by 2.6%. Of those who missed 3 and 6 month follow-up, 66% also missed the 9 month follow-up interview. The range of the percent who missed two or more follow-up interviews was from 1.3% to 11.0% among the study sites. Those who missed two or more follow-up interviews did not differ on baseline demographic factors of the child or caretaker, such as, sex, race, age, marital status, education or income. Similarly, medication use, peak-flow rate, number of unscheduled visits or hospitalizations of the child did not differ. However, children of caretakers who missed follow-up interviews were more likely to slow down play activities because of their asthma (p < 0.01) and had fewer people who assisted with their asthma care (p c 0.01). Their caretakers had less social support (p < 0.091) and perceived more diffmulty keeping medical appointments for childs’ asthma (p < 0.001). It is clear from these findings that caretakers who have less help and less social support, especially for more symptomatic children, are at greater risk of missing follow-up interviews. Additionally, because of the rather long recruitment period (approximately 10 months), the asthma study sites were still performing baseline visits during the beginning of the follow-up phase. This heavy work load during the start up phase may help explain why the follow-up improved over time.
Abstracts
P25 REPRESENTATIVENESS OF CLINICAL TRIAL PARTICIPANTS; THE HEMODIALYSIS STUDY John W. Kusek, Gerald J. Beck, Garabed Eknoyan, Andrew S. Levey, Nathan W. Levin, Daniel B. Ornt, William F. Owen, Gerald Schuhnan and Camille A. Jones from the Hemodiilysis (HEMO) Study National Institutes of Health Bethesda, Maryland Clinical trial results are most useful if the participants are generally representative with respect to the most important prognostic covariates of the general patient population which might be affected by the Bndmgs of the trial. To determine the generaliability of the Hemodiilysis (HEMO) Study, a 2 by 2 factorial randomized clinical trial of treatments impacting adequacy of hemodialysis (HD), a sample of 1170 prevalent HD patients in 15 HEM0 CIinical Centers was surveyed. Characteristics of the randomized participants (n = 353 as of November 1995) were compared to surveyed prevalent HD patients and to HD patients identified by the United States Renal Data System (USRDS), a national database that includes over 90% of the treated end-stage renal disease (ESRD) patients in the U.S. Compared to the prevalent HD patients in the centers, the HEM0 Study participants were similar with respect to mean age (58 vs 57 years), gender (48.8% vs 50.4% women) and the presence of non-insulin dependent diabetes (18.9% vs 21.0%). HEM0 Study participants were less likely to have insulin-dependent diabetes (15.9% vs 23.4%), a history of ischemic heart disease (IHD) (26.9% vs 34.7%) and/or congestive heart failure (CHF) (23.5% vs 31.8%) than prevalent HD patients. HEM0 Study participants were simiir to USRDS HD patients (using similar age range for HEM0 Study entry 18 to 80 years) with respect to mean age (57 yrs vs 57.9 yrs) gender (50.4% vs 48.0% women), and the two most frequent causes of USRD (32.9% vs 28.9% for hypertensive nephrosclerosis, 31.4% vs 32.0% for diabetes). Of patients enrolled in the HEM0 Study, a greater proportion (64.9%) are African American than in the USRDS HI) patient population (39.8%) in 1992. We conclude that randomized HEM0 Study participants to date (the trial will ultimately ‘randomize 1600-1700 patients) are generally representative of surveyed HD patients found in HD units from which they are recruited but include a higher proportion of African Americans than the general U.S. HD patient population, and a lesser proportion with IHD and CHF. P26 MONITORING IN A LARGE MULTICENTRE INTERNATIONAL CLINICAL TRIAL: THE ITALIAN EXPERIENCE IN CORE STUDY E. Bonfanti, E. Gardinale, M.G. Franzosi on behalf of GISSI Investigators ANMCO and Istituto “‘MariaNegri” Milano, Itiy The Collaborative Organization for RheothRx Evaluation (CORE) pilot study evaluated RheothRx in 2948 patients (pts) with Acute Myocardial Infarction (AMI) enrolled by a large number of Coronary Care Units spread aII over the world, foIIowing Good CIinical Practices (GCPs) as required by the Food and Drug Administration (FDA).
107s
Abstracts
Monitoring of the participating centres emerged as one of the main issue, considering the heterogeneity existing among the countries. In Italy monitoring was carried out by the GISSI-Coordinating Centre (CC), which identified some senior cardiologists as monitors of one or two centres each. They were trained by the CC following the Standard Operating Procedures (SOP)s of the study. Monitors had to visit periodically each centre in order to verify the cent& facilities prior the authorization to randomize, and to check the data reported in the study Case Report Forms against source documents (100% of data for the first 3 patients; inclusion, exclusion criteria and a11clinical outcome events for all patients). The presentation will deal with some still open issues of monitoring in clinical trials: . . .
to what extent does auditing allow the identification of errors and fraud; how much on-site record auditing should be performed; what kind of background (clinical or regulatory) is more appropriate to the role of monitor. P27 PREDICTORS OF MISSED FOLLOW-UP INTERVIEWS IN A STUDY OF ASTHMA AMONG INNER-CITY CHILDREN Shaheen U. Islam, Elizabeth C. Wright and Herman E. Mitchell for the NIAID/NIH National Cooperative Inner-City Asthma Study (NCICAS) New England Research Institutes Watertown, Massachuselts
The NCICAS recruited 1528, 4 to 9 year old children from emergency departments and clinics in eight asthma research sites in major cities to evaluate the factors that contribute to asthma morbidity. All study participants completed an extensive baseline interview including demographics, medical history, psychological status, adherence, access to care, spirometry and allergen test. By telephone interview with the caretaker, follow-up information regarding the child’s symptoms and utilization was obtained at 3, 6 and 9 months following the completion of the baseline visit. Of those who completed baseline, 8.9%, 7.7% and 5.4% missed the 3,6 and 9 month followup interviews, respectively. One or more interviews were missed by 13.9%, two or more by 5.5%, and all three follow-up interviews by 2.6%. Of those who missed 3 and 6 month follow-up, 66% also missed the 9 month follow-up interview. The range of the percent who missed two or more follow-up interviews was from 1.3% to 11.0% among the study sites. Those who missed two or more follow-up interviews did not differ on baseline demographic factors of the child or caretaker, such as, sex, race, age, marital status, education or income. Similarly, medication use, peak-flow rate, number of unscheduled visits or hospitalizations of the child did not differ. However, children of caretakers who missed follow-up interviews were more likely to slow down play activities because of their asthma (p < 0.01) and had fewer people who assisted with their asthma care (p c 0.01). Their caretakers had less social support (p < 0.091) and perceived more diffmulty keeping medical appointments for childs’ asthma (p < 0.001). It is clear from these findings that caretakers who have less help and less social support, especially for more symptomatic children, are at greater risk of missing follow-up interviews. Additionally, because of the rather long recruitment period (approximately 10 months), the asthma study sites were still performing baseline visits during the beginning of the follow-up phase. This heavy work load during the start up phase may help explain why the follow-up improved over time.