San Juan Capistrano, CA: I\u2019m in some club. I\u2019m backstage and I have my hands full of two babies. Dads still have to Dad and I have two hands and kids like me, so I\u2019m in the driver\u2019s seat. Some one keeps bringing me Mandarin vodka on the rocks. The kiddos are the most interesting part of the night. I slosh back to my hotel down the street and go to sleep.
In clinical trials, we ask patients to self-report data relating to a number of areas including efficacy, side effects, quality of life, health economics, medication adherence, and treatment satisfaction. Recent draft guidance from the FDA defines a patient reported outcome (PRO) as a measurement of any aspect of a patient's health status that comes directly from the patient, without interpretation of the patient's responses by a physician or anyone else.1 Electronic solutions present significant advantages in the collection of PRO data compared to paper and pencil. In particular, electronic patient diaries can eliminate conflicting or ambiguous data inherent in paper diaries and, importantly, can measure and maintain the required diary reporting schedule so that trialists can demonstrate the contemporaneous nature of their PRO data. In fact, studies in paper diary completion have shown that many patients complete their diaries retrospectively, often just prior to a clinic visit; some even complete their diaries ahead of time.2 Both these behaviors put into question the validity of PRO data collected using paper and are cited as a concern in the draft FDA guidance.1
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Arianna Huffington faced tough questioning from the BBC's Richard Bacon at a debate to launch the London bureau of the Huffington Post, her online community of bloggers. Bacon wanted to know why the Greek millionaire isn't giving her 9,000 bloggers any of the $315m (200m) she is receiving from the sale of HuffPo to AOL. Arianna waffled on about it not being that kind of model. Also disgracing himself was Alastair Campbell, Tony Blair's former spin-doctor, who never tires of promoting himself (a new volume of diaries is out). As he began pronouncing on the phone-hacking, he was asked if Rebekah Brooks wasn't a friend. To which he replied, "She was."
Timothy Spall was visibly enjoying himself at the Harry Potter premier on Thursday, staying late at the after-party at Old Billingsgate. While he didn't join Helena Bonham Carter and Emma Watson for air-punching on the dance floor, he was in high spirits as the champagne and vodka cocktails flowed. Nevertheless, he maintained his discretion when asked about his new status as the Queen's favourite entertainer. It was recently reported that the monarch, a fan of Spall's series on travelling by barge, asked for the DVDs. "I would be greatly honoured if the Queen is watching," says Spall. "I couldn't hope for a higher endorsement. But who knows if it's true?" No BBC producer, surely, would invent this claim?
We investigated the prospective associations between alcohol intake on overall and site- and sex-specific CRC risk. Analyses were conducted on 579 CRC cases and 1996 matched controls nested within the UK Dietary Cohort Consortium using standardised data obtained from food diaries as a main nutritional method and repeated using data from food frequency questionnaire (FFQ).
Many epidemiological studies which investigated an effect of alcohol on health have relied on self-reports of alcohol intakes. Owing to its simplicity in use and convenience in administration, food frequency questionnaires (FFQs) have been mostly used in alcohol intake assessment (Feunekes et al, 1999). However, as a nutritional instrument, FFQs may have both large random and systematic measurement errors (Bingham et al, 2003; Prentice, 2003; Schatzkin et al, 2003), and for a number of nutrients, food diaries have been shown to provide measurements that are more strongly associated with biomarker data (Bingham et al, 1997, 2008; Day et al, 2001). Furthermore, it has been suggested that food diaries can capture a more complicated individual dietary intake more accurately (Bingham et al, 2003). However, less is known about whether food diaries provide a superior measure of food intake for infrequently or episodically consumed items, such as alcoholic drinks, compared with the FFQs. Therefore, it is important to compare the effects of alcohol intake on CRC risk using food diaries and FFQs.
For the food diaries completed by all centres, beer (stout, bitter, lager; keg, draught, bottled, canned; low alcohol, strong, home-made; number of pints, bottles, cans), cider (sweet, dry, vintage, low alcohol; number of pints, bottles, cans), spirits (what sort: e.g., whisky, gin, vodka, rum; at home or in a pub; single measures as in pub), wine, sherry, port (white, red; sweet, medium, dry; low alcohol; glasses) were assessed for alcohol intake.
Table 5 and Figure 1 show a comparison of the results from using FFQ and food diary to obtain measurements of alcohol intake. Analyses using FFQ resulted in a similar pattern of associations to those using food diaries. The association between alcohol intake and CRC risk remains statistically non-significant using FFQ, although suggests an increasing trend in the OR estimates with increasing alcohol intake (P for trend=0.09 among drinkers in multivariable model 1). The distribution of participants across the categories of alcohol intake differed in the FFQ and food diary data. Among the subset of participants with both measurements (n=2305), out of 646 individuals who reported zero intake on the food diary, 305 (47%) reported being non-drinkers on the FFQ. Approximately 95% of individuals (n=613) reporting zero alcohol intake on the food diary consumed 0 alcohol intake on the food diary.
Our study has several strengths. Its prospective study design precluded bias attributable to differential recall of intake of alcohol by case status. We were able to examine the influence of alcohol intake on site- and sex-specific CRC risk. Furthermore, different types of alcoholic beverages from food diaries were assessed in association with CRC risk.
This study provided the measure of alcohol intake by using both food diaries and FFQs, whereas previous studies on alcohol and CRC risk have relied only on FFQs. The use of food diaries and FFQs for habitually consumed food items have been discussed (Bingham et al, 1997, 2003, 2008). However, there have been few direct attempts to compare those two different nutritional instruments prospectively for episodically consumed food items, including alcohol. Previous studies have shown that FFQs were not inferior in measuring alcohol intake relative to prospective food diaries (Feunekes et al, 1999), and FFQs showed a high level of reproducibility and validity compared with diet records as a reference method (Ferraroni et al, 1996). Our study, which has information both from food diaries and FFQs, found that although FFQs and food diaries cover different durations and measurements may differ between the two instruments, using well-constructed food diaries for measurement of infrequently consumed food items can provide results that do not differ substantially from those using FFQs. be457b7860
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