Postal surveys — a view from the other side

Objectives — To explore the reasons why elderly people with arthritis choose to participate in a reliability study conducted by postal survey, and their views of the process of taking part. Methods — Twenty elderly people suffering from arthritis were interviewed in depth. They were chosen on the basis of how they had completed postal questionnaires about their arthritis, on two separate occasions to assess reliability, two weeks apart. Interviews were taped, with permission, and transcribed verbatim. Content analysis of the interview data, and any telephone calls, comments or letters received from all survey recipients, was conducted using NUD‐IST. Key findings — Many respondents thought that such surveys only involved the worst sufferers and that anyone else was “a fraud”. Part of the motivation for individuals to participate was the desire to help the researcher, others with arthritis or, for some respondents, themselves. The details of the questionnaires were used by the respondents as clues to develop their theories of the survey's purpose. There was commonly a failure to perceive the need to complete the questionnaires twice, regardless of whether there had been a change in their health. Some respondents did not see the point of the second questionnaires, some apologised for their unchanged health, and others actively sought to find further information to put into the second set. Conclusion — These results have implications for researchers, by identifying the range of detail required by potential survey respondents to reduce response bias. If the purpose of the survey is not clearly communicated, participants will impose their own, probably different, interpretation, with unexpected consequences.     

Lessons from the other side of the Atlantic

In the United States, bevacizumab was approved for use in combination with paclitaxel for the treatment of metastatic breast cancer on the basis of a single trial showing a beneficial impact on progression-free survival, a surrogate endpoint. The indication in breast cancer was withdrawn in 2011 when a new review of the data showed no increase in overall survival. In the European Union, bevacizumab was approved for use in combination with paclitaxel or docetaxel, again based on an improvement in progression-free survival. Following a review of clinical trials using this same endpoint, the indication for combination with paclitaxel was maintained while the indication for combination with docetaxel was withdrawn in 2011. Furthermore, bevacizumab was approved for use in combination with capecitabine on the basis of progression-free survival data.     

Amiodarone neurotoxicity: the other side of the medal

The efficacy of amiodarone is tempered by its toxicity, with 50% of long-term users discontinuing the drug. The non-cardiac side effects of amiodarone may involve central and peripheral nervous system. We studied two patients treated with amiodarone for 46 and 15 months respectively. Both patients exhibited progressive distal extremity weakness, impaired perception, loss of deep reflexes. Electrophysiology identified a widespread, sensorimotor polyneuropathy with features of axonal loss and demyelination. Visual evoked potentials (VEPs) showed prolonged P₁₀₀ latency bilaterally in absence of visual symptoms or brain magnetic resonance imaging (MRI) abnormalities. Extensive laboratory examinations excluded known causes of peripheral neuropathies. At 21 months after amiodarone withdrawal, P₁₀₀ latency of case 1 VEPs returned to normal, whereas polyneuropathy continued to progress. In the second patient neuropathy has worsened similarly over 2 years whereas P₁₀₀ latency of VEPs recovered to normal within 7 months after withdrawal of amiodarone. These findings may suggest different mechanisms of toxicity, which could be due to amiodarone pharmacokinetic and its metabolite effects on the peripheral nerves, as opposed to the optic nerve. We emphasize that use of amiodarone needs monitoring of patients at risk of development side effects.     

Good laboratory practices and other regulatory issues: A European view

Safety pharmacology studies provide information on the effects of new chemical entities on physiological function in experimental animals and complement classical toxicology studies which assess effects on bodily structure. Data from these studies help to predict possible adverse effects of a compound that might be seen during administration to man, and should therefore be classified as safety studies. It is a regulatory requirement in most areas of the world that safety studies be carried out in compliance with the principles of Good Laboratory Practice. The way in which United Kingdom pharmaceutical companies approach safety pharmacology has been surveyed, and a comparison has been made with practices in the United States. © 1995 Wiley-Liss, Inc.