Paying research participants: a study of current practices in Australia.

OBJECTIVE: To examine current research payment practices and to inform development of clearer guidelines for researchers and ethics committees. DESIGN: Exploratory email based questionnaire study of current research participant reimbursement practices. A diverse sample of organisations and individuals were targeted. SETTING: Australia. PARTICIPANTS: Contacts in 84 key research organisations and select electronic listservers across Australia. A total of 100 completed questionnaires were received with representations from a variety of research areas (for example, market, alcohol and drug, medical, pharmaceutical and social research). MAIN MEASUREMENTS: Open-ended and fixed alternative questions about type of research agency; type of research; type of population under study; whether payment is standard; amounts and mechanisms of payment; factors taken into account when deciding on payment practices; and whether payment policies exist. RESULTS: Reimbursement practice is highly variable. Where it occurs (most commonly for drug dependent rather than health professional or general population samples) it is largely monetary and is for time and out-of-pocket expenses. Ethics committees were reported to be often involved in decision making around reimbursement. CONCLUSIONS: Research subject payment practices vary in Australia. Researchers who do provide payments to research participants generally do so without written policy and procedures. Ethics committees have an important role in developing guidelines in this area. Specific guidelines are needed considering existing local policies and procedures; payment models and their application in diverse settings; case study examples of types and levels of reimbursement; applied definitions of incentive and inducement; and the rationale for diverse payment practices in different settings.

Behavioral components of high-fat diet hyperphagia: meal size and postprandial satiety.

Previously, rats fed a high-fat liquid diet (HF) ad libitum consumed more kilocalories and had greater weight gain than rats fed a liquid high-carbohydrate diet (HC) of equivalent energy density (Warwick, Z. S., and H. P. Weingarten. Am. J. Physiol. Regulatory Integrative Comp. Physiol. 269: R30-R37, 1995). The present series of experiments sought to clarify the behavioral expression of HF hyperphagia by comparing HF and HC with regard to meal size and magnitude of postingestive satiety effect. Meal size of HF was greater than HC at 2.3 kcal/ml and also when diets were formulated at 1.15 kcal/ml. In a preload-test meal paradigm, an orally consumed HF preload was less satiating than a calorically equivalent HC preload across a range of preload volumes and intermeal intervals. Sensory-specific satiety was ruled out as an explanation of the relatively greater intake of test meal after an HF preload meal; an intragastrically delivered HF preload was less satiating than intragastric HC. Furthermore, a fat (corn oil emulsion) preload was less satiating than a carbohydrate (sucrose) preload when an evaporated milk test meal was used. These findings indicate that hyperphagia on an HF diet is expressed in increased meal size and decreased intermeal interval.

Learned suppression of intake based on anticipated calories: cross-nutrient comparisons.

Following training with distinctively flavored solutions which differ in calories and thus in their postingestive effects, rats demonstrate flavor-postingestive consequence learning by preferentially consuming one of the flavors in two-bottle tests (both flavors presented in nutrient-identical solutions). The direction of the preference--for the flavor previously paired with more calories (F-hi) or for the flavor previously paired with fewer calories (F-lo)--depends critically upon the magnitude of postingestive effects experienced during training. The most frequent and more thoroughly investigated observation has been preferential consumption of F-hi (conditioned flavor preference). However, when relatively concentrated solutions (e.g., 5% and 30% sucrose) are used as the training nutrients, F-lo is preferentially consumed in two-bottle tests. This lesser intake of F-hi presumably reflects its previous association with the more potent satiating effect of the highly concentrated nutrient: conditioned satiety. The present series of experiments explored conditioned satiety across nutrient types. In each experiment, rats consumed 30 mL of distinctively flavored nutritive solution per day, alternating between a distinctively flavored high-calorie (1.6 kcal/mL) solution and a lower calorie (0.2 kcal/mL) solution containing a different flavor. Two-bottle testing evaluated whether conditioned satiety was evident. Experiment 1 found that rats trained with sucrose, fructose, glucose, maltodextrin, or saccharin-sweetened medium-chain triglyceride oil emulsion preferentially consumed F-lo in two-bottle tests. In contrast, rats trained with corn oil emulsions tended to preferentially consume F-hi. In Experiment 2, increasing the number of corn oil calories associated with F-hi produced a tendency toward preferential intake of F-lo in two-bottle tests. In Experiment 3, rats consumed a high-fat maintenance diet; sucrose-trained rats again consumed more F-lo than F-hi, whereas rats trained with corn oil emulsions showed a tendency (nonsignificant) to consume more F-lo in two-bottle tests. In Experiment 4, however, adding saccharin to corn oil emulsions did produce conditioned satiety. These findings demonstrate conditioned satiety as a robust phenomenon across various nutrient types; however, corn oil calories entrain conditioned satiety only under certain conditions.

Dental considerations for a Glanzmann's thrombasthenia patient: case report.

Glanzmann's thrombasthenia is a qualitative platelet disorder characterized by a deficiency in the platelet membrane glycoproteins (GP) IIb-IIIa. It belongs to a group of hereditary platelet disorders typified by normal platelet numbers and a prolonged bleeding time. The bleeding seen in Glanzmann's thrombasthenia usually includes bruising, epistaxis, gingival hemorrhage, and menorrhagia. Spontaneous, unprovoked bleeding is unusual. The severity of bleeding is unpredictable in thrombasthenia and does not correlate with the severity of the platelet GP IIb-IIIa abnormality. The present case report describes the dental treatment of a patient with Glanzmann's thrombasthenia. A 39-year-old female with a history of Glanzmann's thrombasthenia presented for periodontal therapy for spontaneous gingival hemorrhage. The patient had been sporadically seen in the past and had a record of only returning for appointments on an "emergency" basis. The periodontal findings revealed a diagnosis of moderate to advanced adult periodontitis in all quadrants. After all dental options had been discussed, the treatment of choice was determined to be extraction of the remaining dentition and fabrication of immediate dentures. The patient received a loading dose of 5 grams of aminocaproic acid (EACA) intravenously 3 hours prior to the surgery. At the beginning of the extractions 1 gram of EACA per hour continuous infusion and a 6 pack of platelets was administered. The patient tolerated the extractions well. All sites healed normally. The patient has had no difficulty in adjusting to the dentures. The case report discusses a possible treatment option in a noncompliant patient having Glanzmann's thrombasthenia and briefly discusses other hereditary bleeding disorders with similar presentations.

A randomized phase I trial of chronic oral etoposide with or without granulocyte-macrophage colony-stimulating factor in patients with advanced malignancies.

Data from an in vitro human tumor-cloning assay suggested synergistic cytotoxicity when etoposide (VP16) and granulocyte-macrophage colony-stimulating factor (GM-CSF) were combined. To explore this potential, we undertook a prospectively randomized three-arm trial in a phase I setting with various schedules of VP16 and GM-CSF. Thirty-one patients were enrolled in the three-arm trial. Arm A consisted of oral VP16 daily for up to 21 days with cycles repeated every 35 days. Arm B included oral VP16 daily for up to 21 days plus concomitant GM-CSF at 5 micrograms/kg/day s.c. days 1-10. Arm C included oral VP16 daily for up to 21 days plus pretreatment with GM-CSF at the same dose for 5 days (days -6 to -2). VP16 was begun at 25 mg/m2/day on level 1 and increased to 50 mg/m2/day on level 2. Twenty-seven patients were evaluable for toxicity, nine on each arm (six patients on each arm on level 1, three patients on each arm on level 2). Neutropenia on arm B (concomitant VP16 and GM-CSF) was earlier and more profound than on arm A or C. The median absolute neutrophil count and day of nadir for arms A, B, and C were 3295, 988, and 1600/mm3 and days 23, 15, and 26, respectively. Thrombocytopenia was generally uncommon except on arm C level 2, where the median platelet count was 26,000/mm3. One partial response (arm B) in a patient with non-small cell lung cancer was seen. Dose intensity favored arm A. Neither concomitant therapy with VP16 and GM-CSF (arm B) nor pretreatment with GM-CSF (arm C) improved dose intensity over VP16 alone (arm A), and arms B and C were complicated by increased neutropenia and thrombocytopenia.

Hypercoagulable states. Their causes and management.

Recognition of patients who should be evaluated for either hereditary or acquired hypercoagulable states is important so that treatment may be instituted if necessary to prevent thrombosis. Close attention to the medical history, medications, family history, and circumstantial risk factors can help identify patients at risk so that morbidity and mortality may be reduced. Patients with hereditary thrombosis should receive lifelong anticoagulation.