• Two auditors: one to ask open questions, the other as witness and scribe. • Interview staff individually, establishing their knowledge of trial procedures and incident. Note conflicting information. • Establish key facts: 1. Were participants real and eligible? 2. Did they consent? 3. Are test/clinical measurements/data valid? 4. Was appropriate treatment/intervention given? 5. Was follow-up ...

It is difficult to draw up a list of medicines that are essential for infants and children. It is clear, however, that many of the medicines used appropriately to treat infants and children are not licensed for such use.1 The medicines concerned may be used outside the terms of their product license, ie, used off-label, or unlicensed for use in children at any age.2 Off-label use appears to be ...

We diagnosed 50 patients (58 shoulders) with a mean age at presentation of 17.3 years, as having involuntary positional instability of the shoulder. They were managed by a programme consisting of a careful explanation, analysis of abnormal muscle couples and then muscle retraining carried out by a specialist physiotherapist. The mean follow-up was two years. Six shoulders had a poor result, but...

BACKGROUND Public opinion polls indicate that a majority of Canadians are in favour of euthanasia. However, there have been many criticisms of the validity of these findings. The objective of this study was to assess public opinion towards euthanasia while controlling for possible threats to validity indicated in the literature review. METHODS A telephone public opinion poll was conducted in ...

BACKGROUND Medications are frequently prescribed outside their regulatory approval (off-label) by physicians particularly where appropriate therapies are not available. However, the risk/benefit ratio of drugs in off-label use needs to be critically appraised because it may differ from approved on-label usage. Therefore, an extensive exploration of current evidence on clinical data is well-advi...

The concept of hormesis, or low-dose U-shaped responses, is now well established in toxicology and pharmacology but requires development in medicine and therapeutics. In doing so, care must be taken to not confuse metaphorical and chemical uses of the term hormesis. Low dose, continuous adaptive responses are fundamentally different than conventional pharmacology, and they may improve the scien...

Introduction Despite their limited licensed indications, anti-IL1 agents are often used in real-life practice for an increasing number of diseases. A national survey to record the off-label use of this class of therapeutics in France was started in January 2011. The survey is coordinated by the French National Reference Centre for Auto-inflammatory Diseases, under the aegis of the “Club Rhumati...

Introduction A factual account of the wounds received by a soldier during one of the land battles in the Falklands Campaign is presented together with an account of his initial (first and second line) and subsequent (third and fourth line) treatment_ Comments and suggestions are offered on aspects of treatment given in the first and second line medical facilities as they existed during the Falk...

Background and Objective: This study assessed price differences by comparing annual treatment costs of similarly available orphan drugs in France, Germany, Italy, Norway, Spain, Sweden, and UK. Methods: Annual treatment costs per drug were calculated using ex-factory prices from IHS POLI and country price databases. The treatment cost in the comparator country was compared to the UK and ratios ...