Afifah Machlaurin

The letter from Mc Bride 1961 about congenital abnormalities In 1962 Frances Oldham Kelsey (FDA) blocked the marketing of thalidomide

Antibiotics were administered to the patient even before an infectious cause of fever was identified.

Why?????

The potential risk of complications from

delayed antibiotic treatment outweighed the likelihood of harm from treatment administered before the cause of the fever was determined.

every treatment decision involves a counterbalancing of risks and benefits how epidemiologic measures can be used to assess outcomes and thereby guide decision making

Risk the likelihood that an individual will contract a disease prevalence the amount of disease already present in a population incidence rate how fast new occurrences of disease arise. In addition, these measures can be used to assess the prognosis and mortality of patients with disease.

risk is the proportion of unaffected individuals who, on average, will contract the disease of interest over a specified period of time.

This study began in 1995 and concluded in 2004. Patient A was enrolled in 1995, was diagnosed with the disease just prior to 1997, and was followed up until death in 2002. Patient B was enrolled in 1997, was followed up until 1999 without developing the disease, and then discontinued participation in the study. Patient C was enrolled in 1999, was diagnosed with the disease just prior to 2002, and survived through the end of the observation period in 2004. Patients D, E, and F entered the study in 1997, 2002, and 1998, respectively; each patient was followed through 2004 without developing the disease.

The 2-year risk of disease, therefore, is estimated by

to estimate a cancer patient's risk of acquiring an infection in the hospital (a nosocomial infection), a study was conducted of 5031 patients admitted to a comprehensive cancer center. The investigators carefully defined a nosocomial infection as an infection that (1) is documented by cultures, (2) was not incubating at admission, (3) occurred at least 48 hours after admission, and (4) occurred no more than 48 hours following discharge (somewhat longer for surgical wound infections). Of the 5031 patients, 596 developed an infection that met these criteria.

1022 cancer patients with fever and granulocytopenia were studied according to a defined protocol. Of these patients, 530 had a clinically or microbiologically documented bacterial infection. Thus, the risk of infection in granulocytopenic, febrile cancer patients is estimated to be

This result suggests that patients similar to the one described in the Patient Profile have a very high risk of a bacterial infection, thus supporting the decision to treat the patient with antibiotics even before an infection is diagnosed.

Prevalence indicates the number of existing cases of the disease of interest in a population

cases (C), the number of persons in the population (N)

Prevalence in 1995

96 people attending an outpatient clinic for the first time. Patients with skin infections were excluded from the study. S aureus was cultured from specimens from 62 patients. The prevalence of colonization with S aureus in this group was

incidence rate measures the rapidity with which newly diagnosed cases of the disease of interest develop

Patient A developed the disease 2 years after entry into the study. Because subjects contribute person-time only while eligible to develop the disease, the person-time for Patient A was 2 years. Similarly, Patients B, C, D, E, and F contributed 2, 3, 7, 2, and 6 years, respectively. Patients A and C developed disease

Thus, A (the number of new cases of disease in the population) = 2, the total PT = 2 + 2 + 3 + 7 + 2 + 6 = 22 personyears,

Returning to the study cited in Example 1, the incidence rate of nosocomial infections can be calculated from additional data reported in that investigation. The 5031 patients remained under observation for a total of 127,859 patientdays (or an average length of stay of 127,859/5031 = 25.4 days). Since 596 patients developed an infection that met the definition for a hospital-acquired infection, the incidence rate can be estimated as

In the United States, the National Cancer Institute maintains a network of registries that collect information on all new occurrences of cancer within populations residing in specific geographic areas. Collectively, these registries cover about 14% of the population of the United States, and between 1996 and 2000, 2957 females were newly diagnosed with acute myelocytic leukemia in these areas. An estimated 19,185,836 females lived in these combined areas on average during this 5-year period. Calculate the IR !

The use of an antibiotic, norfloxacin, was studied for prevention of gram-negative bacterial infections in patients with acute leukemia who had treatment-related low neutrophil counts. All 35 patients who received norfloxacin developed fever. The 35 patients were observed for a total of 220.5 person-days before first developing fever; each day, on average, about 28% of the patients had a fever. Calculate the R, P, and IR !

Survival is the probability of remaining alive for a specific length of time.

S = Survival A = the number of newly diagnosed patients under observation D = the number of newly diagnosed patients under observation

the 2-year survival is

When studying survival and risk, problems may arise if the investigator cannot follow some subjects for the entire risk period Statisticians have developed special techniques called survival analyses,

The horizontal axis plots time in years since diagnosis (0 = time of diagnosis) and the vertical axis plots the percentage of patients who are alive. The survival curve begins at the time of diagnosis, when 100% of patients are alive. During the first year following diagnosis, 32% of the patients die (or equivalently, 100% 32% = 68% survive). During the next year, another 10% of patients die (cumulative survival = 68% 10% = 58%). The process of attrition to death continues each year through the end of the 5-year observation period.

The

percentage of 5 years survivors (47%) is then read from the vertical axis

median survival time = 3 tahun

The propensity of a disease to cause the death of affected patients

Penelitian ini dimulai pada tahun 1995 dan menyimpulkan pada tahun 2004. Seorang pasien yang terdaftar pada tahun 1995, didiagnosa menderita penyakit ini hanya sebelum 1997, dan diikuti sampai meninggal pada tahun 2002. B Pasien terdaftar pada tahun 1997, dilanjutkan hingga 1999 tanpa penyakit, dan kemudian dihentikan partisipasi dalam studi. C Pasien terdaftar pada tahun 1999, didiagnosa menderita penyakit ini hanya sebelum 2002, dan bertahan sampai akhir periode observasi pada tahun 2004. Pasien D, E, dan F memasuki studi pada tahun 1997, 2002, dan 1998, masing-masing; setiap pasien diikuti sampai 2004 tanpa terserang penyakit itu.