Baseline medical data

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... 

The protocol should specify what should be recorded directly into the CRF and what will also be recorded in the medical records. The CRF will contain all the pertinent data associated specifically with the clinical trial but some will be repeated in the medical records, for example, the protocol identification number, date of consent, date of commencement of the study, key baseline medical findings, visit dates, start and finish dates of the study drug/placebo or treatment, concurrent medication, adverse events and key efficacy and any unscheduled or scheduled actions or interventions (such as escape medication). Additional information obtained from biopsy reports, radiographs and similar documents will provide confirmation that the data in the CRF are recorded correctly. Monitors, QA auditors and inspectors need to see all the medical records available to the investigator. It is not appropriate to create copies of data from CRFs or checklists derived from medical records and claim that these are source documents. 

Establishing a common baseline for medical data collection and research, and compatibility or bridging mechanisms for all technologies... 

The considerations so far in this chapter have been on the evaluation of efficacy. For safety we usually define the safety set as the set of subjects who receive at least one dose of study medication. Usually the safety set will coincide with the full analysis set, but not always. There may well be a patient who started on medication, but withdrew immediately because of a side effect. This patient is unlikely to have provided post baseline efficacy data and so could be excluded from the full analysis set. 

Preplacement examination has two major functions (1) determination of an individual s fitness for duty, including the ability to work while wearing protective equipment, and (2) provision of baseline medical surveillance for comparison with future medical data.4 The chemical agent worker must be evaluated to ensure that he is not predisposed to physical, mental, or emotional impairment, which may result in an increased vulnerability to chemical warfare agent exposure. This examination is performed at no cost to the applicant. Abnormalities identified during the course of the... 

Stibine - SbH3, 7803-52-3 flammable, poison by inhalation bp = -17 C [1 F] er = NA sp g = 4.34 OSHA PEL = 0.1 ppm. Odor similar to hydrogen suUrde but data not available as to whether the odor is an adequate warning of the PEL. Toxic hemolytic agent, which causes injury to hver and kidneys. Probable lung irritant. Symptoms of overexposure may be delayed for up to 2 days and would include nausea, headache, vomiting, weakness, and back and abdominal pain. Death would result from renal failure and pulmonary edema. Baseline medical exam should stress blood, hver, and kidneys. Special tests should include complete blood count, urine analysis, and liver panel. 

Verheul et al. (2004) pooled data from seven European acamprosate studies in an effort to identify patient-related predictors of response to the medication. Although they examined a number of potential predictors, including patients level of physiological dependence before treatment, family history of alcoholism, age of onset of alcoholism, baseline anxiety symptom severity, baseline craving, and gender, none was shown to interact with acamprosate treatment. These findings led the authors to conclude that, although the effect size for acamprosate was moderate, the medication can be considered potentially effective for all patients with alcohol dependence. 

Clinical experience suggests that alprazolam can be particularly difficult to taper when lower doses are reached (e.g., tapering from 1 to 0 mg) (Ciraulo et al. 1990). One possible explanation for this is suggested by data from an animal model showing that alprazolam at doses of 0.02—0.05 mg/kg increases benzodiazepine receptor number above baseline (Miller et al. 1987). When difficulty is encountered in tapering the last 1—2 mg of alprazolam, the rate of dose reduction can be decreased to 0.25 mg/week, and/or adjunctive medication may... 

There are several areas of study that will help you understand the research topic. As a first step you will want to read the clinical protocol. The protocol describes the device or medication to be used, the patient populations under study, the statistical plan of the clinical trial, and the details of the disease state. If you want to understand the disease state or indication further, you may want to seek out a clinical investigator of the clinical trial or do some further reading about the disease. Understanding the patient population is a good way to understand the data that you will see and whether there is reason for concern when viewing the data. For example, if you were studying a medication to reduce hypertension, you would not be as worried if patient blood pressure data were elevated at baseline. You would expect to see this because you understand that hypertensive patients have high blood pressure. 

Categorical Data and Why Zero and Missing Results Differ Greatly 102 Performing Many-to-Many Comparisons/Joins 106 Using Medical Dictionaries 108 Other Tricks and Traps in Data Manipulation 112 Common Analysis Data Sets 118 Critical Variables Data Set 118 Change-from-Baseline Data Set 118 Time-to-Event Data Set 121... 

These omissions will not cause bias only under some circumstances. In particular, subjects in each of the treatment groups should receive equal scrutiny for protocol violations and all such violators should be excluded, in relation to the first point. For the second and third points, the fact that patients do not take study medication or do not provide any post-baseline data should be unrelated to the treatments to which such subjects were assigned. Any potential bias arising from these exclusions should be fully investigated. 

After the focus for quality improvement has been chosen, it is important to make sure that it is clear to each team member. This can be accomplished by providing a detailed description of the area chosen for study, the setting in which the focus occurs, the portion of the medication use process affected, and baseline data, if applicable. 

Should describe practice setting, the portion of the medication use process where the focus occurs, and baseline data (if possible). 

Patient data collection is an extremely critical component of a value-added service. The information collected provides pharmacists with important baseline and monitoring parameters for patients. The amount and type of information needed from the patient or other health care providers may differ depending on the service, but nonetheless, this information is the foundation on which the other components of the service are built. Forms can be developed to help pharmacists collect this information (see Figs. 25-2 through 25-4). In addition, some consideration should be given to how this information will be stored (e.g., paper charts or electronic patient database). The information that should be collected from the patient includes demographic information, medical history, family history, and medication history. Since some of the information may need to be collected from other providers and health care institutions, an authorization to release medical information should be signed by the patient and kept as part of the chart (see Fig. 25-5). Lastly, pharmacists should ensure that their site is in compliance with the Health Insurance Portability and Accountability Act (HIPPA) and reinforce to their patients that the information they provide is confidential and secure at the pharmacy. 

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). 

A similar table may be presented for demographic characteristics. Specific characteristics that are important can vary from study to study, but typical ones include gender, age, race, and baseline data of relevance, e.g., weight, blood pressure, and heart rate. Information concerning the use of concomitant or concurrent medications and evaluations of subject adherence or compliance with the trial s treatment schedule is also typically presented. 

The routes of administration should be the same as proposed in the protocol as well as by labeling. This, however, as in some of the studies, requires modifications (e.g., drench in lieu of medicated feeds). In order to minimize autolytic decomposition, necropsy should be performed promptly after death on all animals that die during the study. The necropsy should be performed by a qualified and experienced person. A complete physical examination should be performed, and baseline data should be collected by a qualified and trained worker. Data should be obtained prior to the start of the trial and at reasonable, predetermined intervals thereafter in accordance with the study protocol. 

Epidemiological Clues to a Biological Event. With awareness of the baseline data for their practice setting, nurses should be alert for unusual patterns of disease or health-related indicators. Representative examples of unusual patterns of diseases that might suggest a deliberate bioterrorist act are presented in Table 22.1 (U.S. Army Medical Research Institute of Infectious Diseases [USAMRIID], 2005 U.S. Department of Health and Human Services [USDHHS], 2001). 

Making sure you have baseline vital signs, labs, and other patient data before administering the medication to be compared after the patient receives the medication to determine her or his reaction to the medication. 

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