ABSTRACT
BACKGROUND: Despite recommendations for adherence reporting in clinical trials involving an oral anticancer agent, the frequency and methods of adherence reporting are inconsistent. The purpose of this systematic review is to determine the frequency and type of adherence measures used in oncology and hematology clinical trials of oral anticancer agents and their association with study characteristics including quality, cancer type, stage and treatment type. DESIGN: PubMed was searched of all randomized controlled clinical trials assessing self-administered pharmacological interventions in patients with cancer and published over two years, between 1 January 2011 and 31 December 2012 were evaluated. RESULTS: We identified 70 publications in the PubMed database, comprising 45,118 total patients. Adherence reporting was present in 14 of 70 trials (20%); quantitative reporting was present in three of 70 trials (4%). Method of adherence assessment varied and included medication count, medication diaries and patient self-report. There was no association between adherence reporting and study quality or other study characteristics, although there was a trend towards increased reporting in breast cancer studies, with 46% of the studies reporting adherence (p = 0.0621). In a preliminary analysis, hematology studies (mean Jadad score 2.19 ± 1.47) were found to have significantly lower quality when compared to non-hematology trials (mean Jadad score 3.39 ± 1.37, p = 0.0034). CONCLUSION: This systematic review demonstrates adherence reporting in clinical trials of oral anticancer agents is infrequent. When reported, adherence was not associated with overall study quality or other study characteristics. Given the potential effects of non-adherence on study power and validity, adherence reporting should be encouraged in oncology and hematology clinical trials.
Subject(s)
Antineoplastic Agents/therapeutic use , Neoplasms/diet therapy , Adult , Aged , Female , Humans , Male , Medication Adherence , Middle Aged , Randomized Controlled Trials as TopicABSTRACT
Three hundred and forty-nine breakfast and infant cereal samples were collected at retail level across Canada from 2002 to 2005. They included rice-, soy-, barley-based and mixed-grain infant cereals, corn-, wheat-, rice-based and mixed-grain breakfast cereals, and were analysed for aflatoxins B1, B2, G1 and G2 using a modified AOAC International official method. An immunoaffinity column was used for the cleanup and purification of extracts. Determination of aflatoxins was by LC using post-column derivatization with pyridinium hydrobromide perbromide and fluorescence detection. Results indicated that 50% of both breakfast and infant cereals had detectable levels (limit of detection = 0.002 ng g-1) of aflatoxin B1, which is the most toxic of the four toxins. The levels found varied from 0.002 to 1.00 ng g-1 for aflatoxin B1, from 0.002 to 0.14 ng g-1 for aflatoxin B2, from 0.008 to 0.27 ng g-1 for aflatoxin G1, and from 0.008 to 0.048 ng g-1 for aflatoxin G2. Only 4% of the breakfast cereals and 1% of the infant cereals had aflatoxin B1 levels exceeding 0.1 ng g-1, which is the European Union maximum limit for aflatoxin B1 in baby foods and processed cereal-based foods for infants and young children.
Subject(s)
Aflatoxins/analysis , Edible Grain/chemistry , Food Contamination/analysis , Infant Food/analysis , Aflatoxin B1/analysis , Chromatography, Affinity/methods , Food Analysis/methods , Humans , InfantABSTRACT
Between March 1998 and March 2002, 304 samples of domestic (Canadian) and imported beers from 36 countries were picked up for the determination of aflatoxins B1, B2, G1 and G2. Twelve samples were positive with aflatoxins greater than the limit of quantitation (LOQ) (aflatoxin B1, 4.4 ng l(-1); aflatoxin B2, 3.4 ng l(-1); aflatoxin G1, 11.2 ng l(-1); and aflatoxin G2, 6.2 ng l(-1)). Five samples from Mexico, two samples from Spain and one from Portugal contained aflatoxin B1. Four samples from India contained aflatoxins B1 and B2. The remaining samples contained less than the LOQ for aflatoxins B1, B2, G1 and G2. The analytical method for this survey was based on that of Scott and Lawrence (Scott PM, Lawrence GA. 1997. Determination of aflatoxins in beer. Journal of AOAC International 80:1229-1234.). Aflatoxins B1, B2, G1 and G2 were determined at parts per trillion (ng l(-1)) levels in beer by immunoaffinity column cleanup followed by derivatization with trifluoroacetic acid and reversed-phase liquid chromatography with fluorescence detection.
Subject(s)
Aflatoxins/analysis , Beer/analysis , Poisons/analysis , Aflatoxin B1/analysis , Canada , Chromatography, Liquid/methods , Diet Surveys , Food Contamination/analysis , Quality ControlABSTRACT
Results are reported for a collaborative study of a method for the extraction of light filth from spirulina (a blue-green alga) powder and tablets. A 50 g portion of either powder or tablets is dispersed in water, and then boiled with dilute HCI solution. Hairs and insect fragments are isolated by wet sieving on a No. 230 sieve, flotation with mineral oil, and washings of the mineral oil in a percolator. Average recoveries by 12 collaborators for tablets and powders were 70.6 and 70.2%, respectively, for 10 rat hair spikes and 68.3 and 84.4%, respectively, for 20 insect fragment spikes. The method has been approved interim official first action.
