Participant Recruitment in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

Pressel, Sara L.; Davis, Barry R.; Louis, Gail T.; Adrogué, Horacio J.; Egan, Debra; Farber, Michael A.; Payne, Gerald H.; Probstfield, Jeffrey L.; Ward, Harry J.

doi:10.1016/s0197-2456(01)00177-5

Cited by 35 publications

(32 citation statements)

References 10 publications

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“…Because exposure-monitoring studies tend to be burdensome for participants and offer no therapeutic benefit, the degree to which these activities are successful has a direct bearing on whether a particular exposure-monitoring study achieves its research objectives (Callahan et al, 1995). Although some relevant information related to clinical trials, intervention research, and surveys is available (Pletsch et al, 1995;Fitzgibbon et al, 1998;Julion and Gross, 2000;Janson et al, 2001;Preloran et al, 2001;Pressel et al, 2001;Sorkness et al, 2001), relatively little has been published on recruitment, retention, and compliance results for children's exposure-monitoring studies (Mitchell et al, 1997;Senturia et al, 1998;Adgate et al, 2000;Needham and Sexton, 2000b;Sexton et al, 2000Sexton et al, , 2003.…”

Section: Discussionmentioning

confidence: 99%

“…Children's studies are especially complicated because they involve obtaining consent/assent and cooperation of both the caregiver and the child. Conducting exposure studies among economically disadvantaged groups and people of color is even more challenging because they tend to mistrust investigators; frequently change addresses; lack telephones; and often do not speak English (Pletsch et al, 1995;Fitzgibbon et al, 1998;Julion and Gross, 2000;Janson et al, 2001;Preloran et al, 2001;Pressel et al, 2001;Sorkness et al, 2001;Sexton et al, 2003).…”

Section: Discussionmentioning

confidence: 99%

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Comparison of recruitment, retention, and compliance results for three children's exposure monitoring studies

Sexton

2004

J Expo Sci Environ Epidemiol

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The School Health Initiative: Environment, Learning, Disease (SHIELD) study, the Minnesota Children's Pesticide Exposure Study (MNCPES), and the National Cooperative Inner-City Asthma Study (NCICAS) are three of the most intensive and invasive exposure-monitoring projects ever undertaken in children. An intrinsic facet of each study was the need to recruit children and their families, retain them for the duration of the project, and ensure that they completed monitoring protocols successfully. All of the studies used fiscal incentives to encourage participation, retention, and compliance. Recruitment rates varied from 40% in MNCPES, to 57% in SHIELD, to 64% in NCICAS, while retention rates varied from 85% in SHIELD, to 94% in MNCPES, to 95% in NCICAS. Rates of compliance with exposure sampling procedures were typically 480% for each study. For example, Z85% of the enrolled children provided all requested urine samples (1 for NCICAS, 2 for SHIELD, 3 for MNCPES), and 82% of the children in SHIELD provided two out of two blood samples (optional in MNCPES and NCICAS). However, compliance rates were substantially lower (34% SHIELD, 40% NCICAS, not applicable to MNCPES) for the more complex and time-consuming protocol used to collect peak flow data. Overall, results demonstrate that it is practical and affordable to conduct demanding exposure-monitoring studies in children, including children from poor minority communities.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Comparison of recruitment, retention, and compliance results for three children's exposure monitoring studies

Sexton

2004

J Expo Sci Environ Epidemiol

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“…33 These metaanalyses are heavily weighted by the results of ALLHAT. Octogenarians made up only 6.5% of its participants, 34 but because of its huge size, ALLHAT nearly doubled the number of studied hypertensive patients in this age group. Separate analyses of this age group in ALLHAT Results of a metaanalysis of 1670 hypertensive patients Ͼ80 years of age from 7 clinical trials comparing antihypertensive drug treatment with placebo or no treatment.…”

Section: Should I Start Taking a Drug And If So Which One?mentioning

confidence: 99%

Management of Hypertension in the Very Elderly Patient

Elliott

2004

Hypertension

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Abstract-This Hypertension Grand Rounds discusses pharmacological treatment of hypertension in individuals who have survived 9 decades on earth. This rapidly growing group of relatively active and healthy elderly people is at high risk for hypertension, its treatment, and its adverse consequences, including stroke and heart failure. In this age group, the most common abnormality is elevated systolic blood pressure, which is much more predictive of stroke and heart disease death after 53 years of age. With the possible exception of the Antihypertensive and Lipid Lowering to prevent Heart Attack Trial (ALLHAT), recent clinical trials have emphasized the overriding importance of lowering blood pressure rather than the specific agent chosen to begin therapy. In 1999, a metaanalysis of 7 clinical trials that enrolled 1670 subjects Ͼ80 years of age indicated that active antihypertensive drug therapy significantly reduced stroke by 34% and heart failure by 39% but was associated with a nonsignificant 6% increase in mortality. The HYpertension in the Very Elderly Trial (HYVET) will enroll 2100 patients Ͼ80 years of age and will compare 2 groups randomized to indapamideϮperindopril versus placeboϮplacebo for incident stroke during 5 years of follow-up. This study should answer lingering questions about whether active antihypertensive therapy is associated with a major and significant reduction in cardiovascular morbidity and mortality in this age group as it clearly does in younger hypertensives. Its choice of a diuretic as initial therapy is consistent with other trials, but chlorthalidone is the drug with the most compelling evidence in large US trials that included very elderly patients.

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“…The design of ALLHAT, including the LLT, and its participant and clinical site recruitment and selection have been reported elsewhere. 9,[16][17][18] Briefly, ALLHAT-LLT was a randomized, nonblinded, large simple trial conducted from …”

Section: Study Population and Designmentioning

confidence: 99%

Absence of an interaction between the angiotensin-converting enzyme insertion-deletion polymorphism and pravastatin on cardiovascular disease in high-risk hypertensive patients: The Genetics of Hypertension-Associated Treatment (GenHAT) study

Zee

Boerwinkle

Arnett

et al. 2007

American Heart Journal

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Participant Recruitment in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

Cited by 35 publications

References 10 publications

Comparison of recruitment, retention, and compliance results for three children's exposure monitoring studies

Comparison of recruitment, retention, and compliance results for three children's exposure monitoring studies

Management of Hypertension in the Very Elderly Patient

Absence of an interaction between the angiotensin-converting enzyme insertion-deletion polymorphism and pravastatin on cardiovascular disease in high-risk hypertensive patients: The Genetics of Hypertension-Associated Treatment (GenHAT) study

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