Patient data collection

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. 

The basic format of the history interview will apply to all settings, including acute care, long-term care, ambulatory care, and retail, and can be adjusted to the specific needs of that setting. Utilization of patient data collection forms may be useful for documentation purposes and for guiding the flow and consistency of the interview. There are many sources for the format of data collection forms, which are discussed in a later section. 

Many sources have good examples of patient data collection forms.An example of a patient history form is given in Fig. 1. The format of the form will require modification for the specific care setting and goals of the individual practitioner. 

Rovers, J.P. Currie, J.D. Hagel, H.P., McDonough, R.P. Sobotka, J.L. Patient Data Collection. In A Practical Guide to Pharmaceutical Care American Pharmaceutical Association Washington, DC, 1998 26-55. 

UAAC> 2i To evaluate impact of clinical pharmacy interventions on cost and quality of patient care COD None Personnel costs Physician acceptance, DCA, various quality indicators Annual extrapolated cost savings 19,076 Documented cost and quality using daily patient data collection forms... 

Careful documenfation is always very important since the report on a trial is usually written a long time, sometimes years, after the first patient is entered. The study protocol therefore serves not only as a basis of decisions made during the trial but also as the source of those decisions. The protocol is also important since clinical investigators may change or new ones join the study. In fact, a protocol should be written clearly in order to help researchers to repeat the trial elsewhere. All documents (including patient data collecting forms) should be kept for a long time to provide the possibility to reanalyze the trial if needed. 

Assessments are both initial and ongoing. An initial assessment is made based on objective and subjective data collected when the patient is first seen in a hospital, outpatient clinic, health care provider s office, or other type of health care facility. The initial assessment usually is more thorough and provides a database (sometimes called baseline) from which later data can be compared and decisions made The initial assessment provides information that is analyzed to identify... 

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. 

Prospective sources include encounter data, which may or may not be contained in EHRs patient data input and randomized, prospective clinical trials. Advantages of prospective sources to inform interactive software include the ability to control and monitor the circumstances of data collection reduction (as a result of randomization) of sources of bias potential minimization of missing data potential to modify design of data collection ability to verify data accuracy and ability to validate and further test assumptions and modify existing programs. 

Integrated systems using multiple technologies in the areas of communications, data collection, and management have been developed that allow patients to perform and report critical tests at home (Jones et al. [4]). 

The use of wireless computer systems has gain popularity in data collection for clinical trials. They have been used as a substitute for normal paper-based patient diaries (Koop et al. [19]) to increase data quality and shorten the time needed to close the database. They have also been used for mobile interviewing [20] and for bedside data collection [21]. In patient-directed data entry, subjects are given handheld computers to answer the trial s questions (Clarke et al. [22]). 

There has been a push for direct data collection (DDC) as an alternative to remote data capture (RDC). In this approach most of the required clinical data are acquired directly from existing patient record systems such as MRI machines, ECG, EEG, TTM, laboratories, and other measurement equipment. This approach eliminates the need for paper transcription and reentry to another system. It promises error-free and resource-efficient data capture, which allows early locking of the database and therefore potentially earlier product launch [30]. 

The use of electronic-based data collection and management systems allows the easy tracking of patient progress in the trial. Patient, visit, and form status are tracked. Patient status can be in screening, excluded, randomized, withdrew, or completed study. Similarly, status codes can be assigned to protocol scheduled visits to indicate whether the visit occurs or not. Form status depends on the type of the data collection system. For example a form in a distributed data collection system can be incomplete, filled, completed, altered, or transmitted. ... 

What other patient data should be collected to help formulate a PN prescription ... 

Sometimes you may also see quality-of-life (QOL) data collected for your clinical trial. Quality-of-life data are collected to measure the overall physical and mental well-being of a patient. These data are usually collected with a multiple-question patient questionnaire and may be summed up into an aggregate patient score for analysis. Some commonly used quality-of-life questionnaires are the SF-36 and SF-12 Health Survey, but there are quite a few disease-specific QOL questionnaires available to clinical researchers. 

The strengths of observational cohort studies are the depth and quality of data that may be collected. Even though these studies are imstruc-tured in the sense that there are no limiting criteria in respect of patient, drug or dosage, they are defined in size and duration and data collection methods, whether on paper forms or on computer screens, and they can draw the attention of the participating doctor to particular pieces of information that are highly desirable. Should data be deficient or inconsistent then it is a relatively simple matter to go back to the doctor for clarification. 

Selective COX-2 inhibitors have also been shown to prevent early and late forms of colorectal neoplasia in rat models. Reddy et al. showed that administration of celecoxib inhibited aberrant colonic crypt foci (ACF) induction and multiplicity by about 40-49% in an azoxymethane-induced ACF rat model (81). Later the same investigators also showed that dietary administration of celecoxib can inhibit both the incidence and multiplicity of colon tumors by about 93 % and 97 %, respectively in the same rat model (82). Other researchers reported similar results with the Min mouse model (52). There is little data on human clinical trials with selective COX-2 inhibitors for colorectal tumor prevention. Recently Steinbach et al. conducted a double-blind, placebo-controlled study with 77 patients with FAP, and reported that treatment with celecoxib, a selective COX-2 inhibitor, for 6 mo led to a significant reduction (28%) in the number of colorectal polyps in these patients (50). Collectively, COX-2 nonspecific or specific NSAIDs appear to have chemopreventive activity against colorectal cancer development. Selective... 

Peripheral artery disease (PAD) patients usually feel leg pain when walking, which is caused by insufficient blood flow to keep up with energy demand. The P MRS data collected in a PAD patient group showed prolonged PCr recovery rate (or time constants) in the calf muscle after exhaustive exercise, suggesting the transition from anaerobic to aerobic energy metabolism is delayed due to impaired oxygen supply or mitochondria fimction caused by atherosclerosis. ... 

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