Prior medication data

Concomitant medications and prior medications are collected in one of two forms a list-type free-text format where the medications get coded later by data management, or a pre-categorized data format. Here is the free-text CRF format  

Protocol Name Patient Number - Visit Identifier 

Medication Yes No Start Date Stop Date Reason 

ACE Inhibitor Anticonvulsant Beta Blocker Psychoactive Medication etc. — / / / /  

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Demographics and Trial-Specific Baseline Data 27 Concomitant or Prior Medication Data 27 Medical History Data 29 Investigational Therapy Drug Log 30 Laboratory Data 31 Adverse Event Data 32 Endpoint/Event Assessment Data 35 Clinical Endpoint Committee (CEC) Data 36 Study Termination Data 37 Treatment Randomization Data 38 Quality-of-Life Data 40... 

An essential detail for the statistical programmer to watch for in prior or concomitant medications data is whether or not the start and stop dates are important for analyses. Unfortunately, it is often the case that the importance of the timing of prior or concomitant medications is not determined until after much of the data have been entered or even after the database is closed to entry. For instance, it may be decided later that a specific concomitant medication has to be watched carefully for interaction with a medication used in the study. If insufficient attention was placed on the quality of the medication start and stop dates, then determining whether there is overlap with study medication is difficult if not impossible. 

A Caution Hydrogen fluoride and fluorine are dangerous materials. Exposure to them will cause severe, painful, and perhaps fatal injury. Exposure may not be evident for several hours. The procedures described here pose the risk of exposure to hydrogen fluoride and to elemental fluorine and should only be carried out by, or under the direct supervision of, qualified professionals. Qualified first aid treatment and professional medical resources must be established prior to working in the area. Prompt treatment is necessary to reduce the severity of damage from exposure and should be sought immediately following exposure or suspected exposure. Material safety data sheets are available from HF and fluorine suppliers. Their recommendations should be followed scrupulously. 

To compare the epidemiological, clinical, and economic impacts of the HIV epidemic in Italy prior to and after the introduction of HAART, Tramarin et al. (2004) conducted a prospective and observational study with a multi-center design. They used data collected on an AIDS cohort from 1994 and updated data from a comparable cohort in 1998. Mortality and medical costs of 251 patients were measured in 1994 and in 1998, respectively. A considerable difference was observed in mortality (33.9% in 1994 vs. 3.9% in 1998). The cost per patient per year was US 15,515 in 1994 and US 10,312 in 1998. Based on the comparison of the two cohorts between both years, the authors concluded that after the introduction of HAART, hospital-based provision shifted from an inpatient-based to an outpatient-based service, with major focus on pharmaceutical care. 

The Parties agree to adhere to the principles of medical confidentiality in relation to Clinical Trial Subjects involved in the Clinical Trial. Personal data shall not be disclosed to the Sponsor by the NHS Trust save where this is required directly or indirectly to satisfy the requirements of the Protocol or for the purpose of monitoring or adverse event reporting. The Sponsor shall not disclose the identity of Clinical Trial Subjects to third parties without prior written consent of the Clinical Trial Subject, in accordance with the requirements of the Data Protection Act 1998 and the principles set out in the Report of the Caldicott Committee on the review of patient identifiable information dated December 1997, a copy of which the NHS Trust shall supply to the Sponsor on request. 

Crossover designs have a number of problems that can invalidate their results. The chief difficulty concerns carryover, that is, the residual influence of treatments in subsequent treatment periods... When the crossover design is used it is therefore important to avoid carryover. This is best done by selective and careful use of the design on the basis of adequate knowledge of both the disease area and the new medication. The disease understudy should be chronic and stable. The relevant effects of the medication should develop fully within the treatment period. The washout periods should be sufficiently long for complete reversibility of drug effect. The fact that these conditions are likely to be met should be established in advance of the trial by means of prior information and data. ... 

Consolidated Diesel of Whitakers, N.C., uses material safety data sheets to screen all hazardous materials coming into the plant (Kohl 1984). The company routes MSDSs through hazardous material and medical personnel during the requisition process. The approval of these individuals is required before a substance is allowed onto the plant site. This ensures that each substance is properly documented and evaluated in terms of its hazardous characteristics prior to its use. This can reduce hazardous waste generation by preventing the use of some materials which would require regulated disposal. 

Cynthia is using a secondary data source to conduct her cost-benefit analysis. After she has identified her variables of interest, she asks the HMO to provide her with baseline information on all heart failure patients prior to implementing her service. The HMO is able to stratify the data by diagnosis, so Cynthiaasks for annual numbers and costs of hospitalizations, emergency room visits, and medications for their heart failure patients (see Table 27-3). 

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