Study specific questionnaire

We suspect that the magnitude of most of the associations noted between meat or coffee and specific fatal diseases are somewhat underestimated because Adventists may tend to underreport the amount of meat or coffee they use. If a substantial number of subjects actually use more meat and coffee than they reported on the Initial questionnaire, it would tend to make it harder to find the real associations, and the observed associations would tend to be weaker. Furthermore, we may have missed associations because subjects changed their habits during the 21-year follow-up period. All observed associations are based on meat and coffee use at the time subjects completed the baseline questionnaire (1960). Subsequent changes in these habits would tend to reduce or eliminate the possibility of finding disease associations with these habits. Failure to find associations, or detection of weak associations, could also result from the fact that our study population contains relatively few subjects who are very heavy users of meat or coffee, while it contains an abundance of subjects who have no exposure to these items. 

Prospective, multisite, uncontrolled clinical studies were conducted to study the effectiveness of the formulations and the acceptability of the polym ethane delivery system. The formulation was imbibed into 2.5-in. hydrophilic polyurethane foam discs (LMI, St. Charles, MI). Each disc contained 2.4 g of the formulation. The method of application was developed in tests that limited the active ingredient to the same amount or less than the monograph specifications for the formulation ingredients. Fourteen volunteers were given boxes containing 42 individually wrapped foam pads impregnated with the fonnulation and were asked to complete the questionnaire weekly. 

Decarli A, Franceschi S, Ferraroni M, Gnagnarella P, Parpinel MT, La Vecchia C, Negri E, Salvini S, Falcini F, Giacosa A. 1996. Validation of a food-frequency questionnaire to assess dietary intakes in cancer studies in Italy. Results for specific nutrients. Ann Epidemiol 6 110-118. 

Franceschi S, Negri E, Salvini S, Decarli A, Ferraroni M, Filiberti R, Giacosa A, Talamini R, Nanni O, Panarello G, et al. 1993. Reproducibility of an Italian food frequency questionnaire for cancer studies Results for specific food items. Eur J Cancer 29A 2298-2305. 

To evaluate aspects of HRQL that are specific to a particular disease or condition, specific measures also may be used. Specific measures include only important aspects of HRQL that are relevant to the patients being studied, such as the loss of function patients experience from asthma or the amount of pain they have from arthritis. Disadvantages of using specific measures are that they are not comprehensive and cannot be used to compare across conditions. They also cannot measure unforeseen side effects or conditions. Examples of specific instruments for heart failure are the Minnesota Living with Heart Failure Questionnaire and the Chronic Heart Failure Questionnaire (Guyatt et al., 1989 Rector, Kubo, and Cohn, 1987). 

Most of the problems associated with the questionnaire were due to a lack of explicit hypotheses as to potential long-term effects of the drugs studied. Questions of general interest were included, but specific hypotheses were not assessed with questions. Furthermore, the survey instrument was a questionnaire, not an interview. The questions therefore had to be simple, easily understood, and able to be answered quickly. Such constraints limit the specificity and detail of the information to be collected. 

Example 3. Butler et al. (2003) conducted a population-based case-control study that evaluated levels of HCAs, meat intake according to doneness and cooking method, and the risk of colon cancer. The study population consisted of participants selected from 33 counties in North Carolina who were part of the North Carolina Colon Cancer Study. Cases included 274 blacks and 346 whites, between the ages of 40 and 84 with invasive adenocarcinoma of the colon diagnosed from 1996 to 2000. Controls, 426 blacks and 611 whites, were randomly selected from the North Carolina Division of Motor Vehicles (under 65) and the Center for Medicare and Medicaid services (over 65). Exposure was assessed using a food-frequency questionnaire. Meat intake frequency data, cooking method, and level of doneness was used to estimate exposure values for three specific HCAs. (Results of this study are discussed in Section 26.2.2b.). Source Butler et al. (2003). 

Other data sets, with a broader coverage of jobs throughout the population, are likely to be needed for estimation of pesticide exposures in case-control studies. For example, Stewart and co-workers (Stewart and Stewart, 1994 Stewart et al, 1998) have used detailed occupational questionnaires with job-specific modules, together with data from the US Occupational Safety and Health Administration (OSHA) Integrated Management Information System to aid in assigning study subjects exposures to multiple chemicals, including pesticides. 

Besides the paucity of historic data, another difficnlty associated with mental health studies of disaster victims is the lack of standardization of criteria used for case definitions of mental health disorders following mass trauma, such as post-traumatic stress disorder (PTSD) (6,7). Diagnostic criteria for PTSD, as noted in the fourth edition of the diagnostic and statistical manual (DSM-IV), should go beyond specified combinations of symptoms to include requirements for symptom duration and the patient s ability to function (6,7). Specifically, for a PTSD diagnosis, the patient must have symptoms for more than 1 month, and the symptoms must cause clinically significant distress or impair the patient s ability to function (6,7). In addition, the symptoms must occur after the traumatic event and could not have existed before the event. Unfortunately, many studies have used questionnaires that fail to distinguish new symptoms following traumatic events from previous prevalent symptoms such as sleeplessness that many people have at various times (6). The consequence is that many studies tend to inflate the prevalence of PTSD. 

More than 5 million (estimated range 4 to 7 million) adults age 40 years or more have PAD and 95% of individuals with PAD have at least one cardiovascular risk factor the majority of patients have multiple risk factors for CVD. Based on the PAD Awareness, Risk, and Treatment New Resources for Survival (PARTNERS) program, the prevalence of PAD in primary care practices is high, yet physician awareness of the PAD diagnosis is relatively low. In this cross-sectional study, PAD was detected in 29% of 6979 patients and 83% of the patients were aware of their diagnosis but only 49% of their patients physicians were aware. The reason for this observation is that patient self-report of symptoms and the use of questionnaires to detect PAD are not sufficiently sensitive and specific to reproducibly diagnosis PAD and the cardinal symptom of PAD, intermittent claudication, is present in the minority of patients (1 to 27%). A simple ABI measurement wiU identify a large number of patients with previously... 

Unfortunately, most treatments for COPD have not been shown to improve survival or to slow the progressive dechne in lung function. However, many therapies do improve pulmonary function and quality of hfe and reduce exacerbations and duration of hospitalization. Several disease-specific quahty-of-life measures are available to assess the overah efficacies of therapies for COPD, including the Chronic Respiratory Questionnaire (CRQ) and the St. George s Respiratory Questioimaire (SGRQ). These questionnaires measure the impact of various therapies on such disease variables as severity of dyspnea and level of activity they do not measure impact of therapies on survival. While early studies of COPD therapies focused primarily on... 

In addition to the briefing, study volunteers were asked to complete a questionnaire designed to obtain information on specific criteria that could disqualify them from participating in the study. Exclusion criteria consisted of conditions that would impact the validity of either study effects or exposure measures. Those criteria were as follows ... 

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