SBIR-STTR Award

Longitudinal trials are trials in which researchers track outcomes over a period of time. These trials play a prominent role in many fields including drug abuse, aging, medicine, social science, and education. Longitudinal studies, by their nature, often address issues that have important implications for long-term health and development. Also, because these studies are often seen as definitive, their results may have a substantial impact on policy. There have been more than 50,000 of these studies published, and the use of this design has been increasing in recent years. The statistical procedures required to plan and to analyze a longitudinal trial are substantially more complex than those used for simple randomized trials. Popular software packages such as SPSS, SAS, and Stata include modules for the analysis of longitudinal trials, and the vast majority of these trials are analyzed using these kinds of modules. By contrast, there is no commercial software to compute power for these trials, and the use of proper techniques to compute power when these studies are being planned is extremely rare. In most cases researchers compute power by ignoring the longitudinal aspect of the study and using techniques intended for simple randomized trials. This is a serious problem because this approach can yield estimates of power that are substantially in error. The goal of this project is to develop software to compute power for longitudinal studies. The program will work with an array of study designs, and it will incorporate a sophisticated user interface to address the kinds of real-world issues that must be addressed in a power analysis. On the input side, it will allow users to enter the kinds of data that they are likely to have, and to do so using a clear and intuitive interface. On the output side the program will create tables and graphs that allow the user to quickly assess the impact of all assumptions, and to determine how changes in the design would affect power and costs.

Public Health Relevance:
Longitudinal trials are trials in which researchers track outcomes over a period of time. These kinds of trials play a prominent role in medicine, health, and social policy research, with more than a thousand such trials being planned each year. The goal of this project is to develop software to compute power for longitudinal studies and other studies that use repeated-measures designs. The program will enable researchers to design these trials to yield the highest possible power within the limitations set by financial and other practical constraints.

Thesaurus Terms:
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Longitudinal trials are trials in which researchers track outcomes over a period of time. These trials play a prominent role in many fields including drug abuse, aging, medicine, social science, and education. Longitudinal studies, by their nature, often address issues that have important implications for long-term health and development. Also, because these studies are often seen as definitive, their results may have a substantial impact on policy. There have been more than 50,000 of these studies published, and the use of this design has been increasing in recent years. The statistical procedures required to plan and to analyze a longitudinal trial are substantially more complex than those used for simple randomized trials. Popular software packages such as SPSS, SAS, and Stata include modules for the analysis of longitudinal trials, and the vast majority of these trials are analyzed using these kinds of modules. By contrast, there is no commercial software to compute power for these trials, and the use of proper techniques to compute power when these studies are being planned is extremely rare. In most cases researchers compute power by ignoring the longitudinal aspect of the study and using techniques intended for simple randomized trials. This is a serious problem because this approach can yield estimates of power that are substantially in error. The goal of this project is to develop software to compute power for longitudinal studies. The program will work with an array of study designs, and it will incorporate a sophisticated user interface to address the kinds of real-world issues that must be addressed in a power analysis. On the input side, it will allow users to enter the kinds of data that they are likely to have, and to do so using a clear and intuitive interface. On the output side the program will create tables and graphs that allow the user to quickly assess the impact of all assumptions, and to determine how changes in the design would affect power and costs.

Thesaurus Terms:
0-11 Years Old;21 Year Old;Anova;Accounting;Address;Adolescent;Adolescent Youth;Advocate;Affect;Age;Aging;Analysis Of Variance;Applications Grants;Behavior;Bibliography;Biological Factors;Birth;Cerebral Palsy;Child;Child Development;Child Youth;Child Health Care;Children (0-21);Clinical Trials Design;Cognitive;Communities;Complex;Computer Programs;Computer Software;Data;Data Banks;Data Bases;Databank, Electronic;Databanks;Database, Electronic;Databases;Development;Dimensions;Disease Progression;Drug Abuse;Drug Usage;Education;Educational Aspects;Emotional;Ensure;Environmental Factor;Environmental Risk Factor;Equilibrium;Event;Flr;Factor, Biologic;Failure (Biologic Function);Family;Feedback;Funding;Funding Agency;Funding Source;Gerontology;Gestation;Goals;Grant;Grant Proposals;Grants, Applications;Graph;Grips;Health;Health Sciences;Health, Child;Human, Child;Infant And Child Development;Intervention;Intervention Strategies;Intuition;Investigators;Investments;Justice;Kidney Diseases;Longitudinal Studies;Measurement;Measures;Medicine;Methods And Techniques;Methods, Other;Mining;Minings;Modeling;Mortality;Mortality Vital Statistics;Nimh;National Children's Study;National Institute Of Mental Health;National Institute Of Mental Health (U.S.);National Institute Of Neurological Disorders And Stroke;National Institute On Aging;Natural Products;Nature;Needs Assessment;Negative Finding;Nephropathy;Observational Study;Outcome;Output;Paper;Parturition;Patients;Pattern;Perinatal;Persons;Play;Policies;Policy Research;Population;Pregnancy;Prevention;Procedures;Process;Programs (Pt);Programs [publication Type];Psychosocial Factor;Pubmed;Publications;Publishing;Randomized;Renal Disease;Reporting;Research;Research Design;Research Personnel;Researchers;Risk;Role;Running;Sbir;Sbirs (R43/44);Sched;Sampling;Sampling Errors;Schedule;Schools;Science Of Medicine;Scientific Publication;Senescence;Series;Side;Small Business Innovation Research;Small Business Innovation Research Grant;Social Policies;Social Sciences;Software;Structure;Study Type;Substance Of Abuse;Sum;Survival Analyses;Survival Analysis;Techniques;Testing;Time;Time Study;United States National Institute Of Mental Health;Variance Analyses;Violence;Woman;Work;Youth;Youth 10-21;Abuse Of Drugs;Abuses Drugs;Aged;Anti Social;Antisocial;Balance;Balance Function;Base;Biogerontology;Children;Clinical Data Repository;Clinical Data Warehouse;Commercialization;Community;Computer Program /Software;Computer Program/Software;Cost;Data Repository;Data Structure;Design;Designing;Develop Software;Developing Computer Software;Drug Use;Environmental Risk;Failure;Falls;Grasp;Healthy Aging;Improved;Interventional Strategy;Juvenile;Juvenile Human;Kidney Disorder;Long-Term Study;Longitudinal Analysis;Longitudinal Design;Model;Peer;Programs;Psychosocial Variables;Randomisation;Randomization;Randomized Trial;Randomly Assigned;Relational Database;Renal Disorder;Science Education;Senescent;Simulation;Social Role;Software Development;Study Design;Substances Of Abuse;Trend;Twenty-One Year Old;Violent;Violent Behavior;Wasting;Web Site;Working Group;Youngster