Analysis of patients' narratives posted on social media websites on benfluorex's (Mediator® ) withdrawal in France.

WHAT IS KNOWN AND OBJECTIVE: Websites and discussion lists on health issues are among the most popular resources on the Web. Use experience reported on social media websites may provide useful information on drugs and their adverse reactions (ADRs). Clear communication on the benefit/harm balance of drugs is important to inform proper use of drugs. Some data have shown that communication (advisories or warnings) is difficult. This study aimed to explore the Internet as a source of data on patients' perception of risk associated with benfluorex and the impact of wider media coverage. METHODS: Three French websites were selected: Doctissimo, Atoute.org considered the best-known and visited website in France for health questions and Vivelesrondes (Long live the Tubbies) for overweight people. Three periods were chosen: (1) before November 2009 (i.e. before benfluorex withdrawal), (2) between November 2009 and November 2010 (when the risk of valvulopathy with benfluorex appeared in social media) and (3) after November 2010. RESULTS AND DISCUSSION: Two hundred twenty initial postings were analysed. These lead to 660 secondary postings which were analysed separately. In period 1, 114 initial postings were analysed, mostly concerning efficacy of the drug (72%). In period 2, 42 initial postings were analysed involving mainly ADRs or warnings (73%). In period 3, 64 initial postings were analysed; most frequent expressing anger directed at the healthcare system (58%) and anxiety about cardiovascular ADRs (30%). Online consumer postings showed that there were drastic changes in consumers' perceptions following media coverage. WHAT IS NEW AND CONCLUSION: This study suggests that analysis of website data can inform on drug ADRs. Social media are important for communicating information on drug ADRs and for assessing consumer behaviour and their risk perception.

What people close to death say about euthanasia and assisted suicide: a qualitative study.

OBJECTIVE: To explore the experiences of people with a "terminal illness", focusing on the patients' perspective of euthanasia and assisted suicide. METHOD: A qualitative study using narrative interviews was conducted throughout the UK. The views of the 18 people who discussed euthanasia and assisted suicide were explored. These were drawn from a maximum variation sample, who said that they had a "terminal" illness, malignant or non-malignant. RESULTS: That UK law should be changed to allow assisted suicide or voluntary euthanasia was felt strongly by most people. Those who had seen others die were particularly convinced that this should be a right. Some had multiple reasons, including pain and anticipated pain, fear of indignity, loss of control and cognitive impairment. Those who did not want to be a burden also had other reasons for wanting euthanasia. Suicide was contemplated by a few, who would have preferred a change in the law to allow them to end their lives with medical help and in the company of family or friends. The few who opposed a change in UK law, or who felt ambivalent, focused on involuntary euthanasia, cited religious reasons or worried that new legislation might be open to abuse. CONCLUSION: Qualitative research conducted on people who know they are nearing death is an important addition to the international debate on euthanasia and assisted suicide. Those who had seen others die were particularly convinced that the law should be changed to allow assisted death.

Is 'watchful waiting' a real choice for men with prostate cancer? A qualitative study.

OBJECTIVE: To understand what leads men to choose 'watchful waiting' rather than active treatment for cancer of the prostate. PATIENTS AND METHODS: Fifty men with confirmed prostate cancer in England, Wales and Scotland were interviewed about all aspects of their illness, for a Database of Individual Patients' Experience of illness. The sample included men at different stages of diagnosis and with experience of a wide range of treatments. We report here only what men said about their choice of treatment and the decision-making process. RESULTS: Watchful waiting would have been clinically inappropriate for almost half of the men (those with serious urinary symptoms and those with metastatic disease). However, few of the men who might have chosen watchful-waiting remembered this being presented as a serious option. Most in this group chose radical prostatectomy, radiotherapy, brachytherapy or cryosurgery. The few who chose watchful waiting had found doctors who supported their decision, had assessed the evidence from Internet sites, and were concerned about the side-effects and uncertain outcome of treatment. Men who chose watchful waiting, as well as those who opted for treatment, described considerable pressure from family members, doctors or support groups, to seek active treatment. CONCLUSION: This study helps to explain why some men will not contemplate watchful waiting, and why others may find it difficult to pursue that option. Understanding men's concerns may help clinicians to support men's treatment decisions. Treatment for prostate cancer is highly controversial because no randomized, controlled trials have shown whether or not active intervention increases survival. If trials are not completed it cannot be determined whether active treatments are the best course of action for men with prostate cancer.

Melatonin for the prevention and treatment of jet lag.

BACKGROUND: : Jet-lag commonly affects air travellers who cross several time zones. It results from the body's internal rhythms being out of step with the day-night cycle at the destination. Melatonin is a pineal hormone that plays a central part in regulating bodily rhythms and has been used as a drug to re-align them with the outside world. OBJECTIVES: : To assess the effectiveness of oral melatonin taken in different dosage regimens for alleviating jet-lag after air travel across several time zones. SEARCH STRATEGY: : We searched the Cochrane Controlled Trials Register, MEDLINE, EMBASE, PsychLit and Science Citation Index electronically, and the journals 'Aviation, Space and Environmental Medicine' and 'Sleep' by hand. We searched citation lists of relevant studies for other relevant trials. We asked principal authors of relevant studies to tell us about unpublished trials. Reports of adverse events linked to melatonin use outside randomised trials were searched for systematically in 'Side Effects of Drugs' (SED) and SED Annuals, 'Reactions Weekly', MEDLINE, and the adverse drug reactions databases of the WHO Uppsala Monitoring Centre (UMC) and the US Food & Drug Administration. SELECTION CRITERIA: : Randomised trials in airline passengers, airline staff or military personnel given oral melatonin, compared with placebo or other medication. Outcome measures should consist of subjective rating of jet-lag or related components, such as subjective wellbeing, daytime tiredness, onset and quality of sleep, psychological functioning, duration of return to normal, or indicators of circadian rhythms. DATA COLLECTION AND ANALYSIS: : Ten trials met the inclusion criteria. All compared melatonin with placebo; one in addition compared it with a hypnotic, zolpidem. Nine of the trials were of adequate quality to contribute to the assessment, one had a design fault and could not be used in the assessment. Reports of adverse events outside trials were found through MEDLINE, 'Reactions Weekly', and in the WHO UMC database. MAIN RESULTS: : Nine of the ten trials found that melatonin, taken close to the target bedtime at the destination (10pm to midnight), decreased jet-lag from flights crossing five or more time zones. Daily doses of melatonin between 0.5 and 5mg are similarly effective, except that people fall asleep faster and sleep better after 5mg than 0.5mg. Doses above 5mg appear to be no more effective. The relative ineffectiveness of 2mg slow-release melatonin suggests that a short-lived higher peak concentration of melatonin works better. Based on the review, the number needed to treat (NNT) is 2. The benefit is likely to be greater the more time zones are crossed, and less for westward flights. The timing of the melatonin dose is important: if it is taken at the wrong time, early in the day, it is liable to cause sleepiness and delay adaptation to local time. The incidence of other side effects is low. Case reports suggest that people with epilepsy, and patients taking warfarin may come to harm from melatonin. REVIEWER'S CONCLUSIONS: : Melatonin is remarkably effective in preventing or reducing jet-lag, and occasional short-term use appears to be safe. It should be recommended to adult travellers flying across five or more time zones, particularly in an easterly direction, and especially if they have experienced jet-lag on previous journeys. Travellers crossing 2-4 time zones can also use it if need be. The pharmacology and toxicology of melatonin needs systematic study, and routine pharmaceutical quality control of melatonin products must be established. The effects of melatonin in people with epilepsy, and a possible interaction with warfarin, need investigation.

Quality of Cochrane reviews: assessment of sample from 1998.

OBJECTIVE: To assess the quality of Cochrane reviews. DESIGN: Ten methodologists affiliated with the Cochrane Collaboration independently examined, in a semistructured way, the quality of reviews first published in 1998. Each review was assessed by two people; if one of them noted any major problems, they agreed on a common assessment. Predominant types of problem were categorised. SETTING: Cyberspace collaboration coordinated from the Nordic Cochrane Centre. STUDIES: All 53 reviews first published in issue 4 of the Cochrane Library in 1998. MAIN OUTCOME MEASURE: Proportion of reviews with various types of major problem. RESULTS: No problems or only minor ones were found in most reviews. Major problems were identified in 15 reviews (29%). The evidence did not fully support the conclusion in nine reviews (17%), the conduct or reporting was unsatisfactory in 12 reviews (23%), and stylistic problems were identified in 12 reviews (23%). The problematic conclusions all gave too favourable a picture of the experimental intervention. CONCLUSIONS: Cochrane reviews have previously been shown to be of higher quality and less biased on average than other systematic reviews, but improvement is always possible. The Cochrane Collaboration has taken steps to improve editorial processes and the quality of its reviews. Meanwhile, the Cochrane Library remains a key source of evidence about the effects of healthcare interventions. Its users should interpret reviews cautiously, particularly those with conclusions favouring experimental interventions and those with many typographical errors.

Melatonin for preventing and treating jet lag.

BACKGROUND: Jet-lag commonly affects air travellers who cross several time zones. It results from the body's internal rhythms being out of step with the day-night cycle at the destination. Melatonin is a pineal hormone that plays a central part in regulating bodily rhythms and has been used as a drug to re-align them with the outside world. OBJECTIVES: To assess the effectiveness of oral melatonin taken in different dosage regimens for alleviating jet-lag after air travel across several time zones. SEARCH STRATEGY: We searched the Cochrane Controlled Trials Register, MEDLINE, EMBASE, PsychLit and Science Citation Index electronically, and the journals 'Aviation, Space and Environmental Medicine' and 'Sleep' by hand. We searched citation lists of relevant studies for other relevant trials. We asked principal authors of relevant studies to tell us about unpublished trials. Reports of adverse events linked to melatonin use outside randomised trials were searched for systematically in 'Side Effects of Drugs' (SED) and SED Annuals, 'Reactions Weekly', MEDLINE, and the adverse drug reactions databases of the WHO Uppsala Monitoring Centre (UMC) and the US Food & Drug Administration. SELECTION CRITERIA: Randomised trials in airline passengers, airline staff or military personnel given oral melatonin, compared with placebo or other medication. Outcome measures should consist of subjective rating of jet-lag or related components, such as subjective wellbeing, daytime tiredness, onset and quality of sleep, psychological functioning, duration of return to normal, or indicators of circadian rhythms. DATA COLLECTION AND ANALYSIS: : Ten trials met the inclusion criteria. All compared melatonin with placebo; one in addition compared it with a hypnotic, zolpidem. Nine of the trials were of adequate quality to contribute to the assessment, one had a design fault and could not be used in the assessment. Reports of adverse events outside trials were found through MEDLINE, 'Reactions Weekly', and in the WHO UMC database. MAIN RESULTS: : Nine of the ten trials found that melatonin, taken close to the target bedtime at the destination (10pm to midnight), decreased jet-lag from flights crossing five or more time zones. Daily doses of melatonin between 0.5 and 5mg are similarly effective, except that people fall asleep faster and sleep better after 5mg than 0.5mg. Doses above 5mg appear to be no more effective. The relative ineffectiveness of 2mg slow-release melatonin suggests that a short-lived higher peak concentration of melatonin works better. Based on the review, the number needed to treat (NNT) is 2. The benefit is likely to be greater the more time zones are crossed, and less for westward flights. The timing of the melatonin dose is important: if it is taken at the wrong time, early in the day, it is liable to cause sleepiness and delay adaptation to local time. The incidence of other side effects is low. Case reports suggest that people with epilepsy, and patients taking warfarin may come to harm from melatonin. REVIEWER'S CONCLUSIONS: Melatonin is remarkably effective in preventing or reducing jet-lag, and occasional short-term use appears to be safe. It should be recommended to adult travellers flying across five or more time zones, particularly in an easterly direction, and especially if they have experienced jet-lag on previous journeys. Travellers crossing 2-4 time zones can also use it if need be. The pharmacology and toxicology of melatonin needs systematic study, and routine pharmaceutical quality control of melatonin products must be established. The effects of melatonin in people with epilepsy, and a possible interaction with warfarin, need investigation.

Oestrogens and progestogens for preventing and treating postnatal depression.

BACKGROUND: Postnatal depression, with a prevalence of at least 10%, is probably the most common complication of the puerperium. A deficiency or imbalance of sex hormones has repeatedly been suggested as a cause. OBJECTIVES: The objective of this review was to evaluate the role of oestrogens and progestogens in the prevention and treatment of postnatal depression. SEARCH STRATEGY: The register of clinical trials maintained and updated by the Cochrane Pregnancy and Childbirth Group. SELECTION CRITERIA: All trials were considered in which pregnant or postpartum women (up to 18 months) were randomised to receive postpartum oestrogen or progestogen or placebo for the treatment or prevention of postnatal depression. DATA COLLECTION AND ANALYSIS: Two published randomised placebo controlled trials were identified for inclusion in the analyses for this review. One study was excluded. MAIN RESULTS: Depot norethisterone enanthate given within 48 hours of delivery and lasting 8-12 weeks was associated with significantly higher postpartum depression scores than placebo. Oestrogen therapy in severely depressed women was associated with a greater improvement in depression scores than placebo. REVIEWER'S CONCLUSIONS: There is no place for synthetic progestogens in the prevention of treatment of postnatal depression. Long-acting norethisterone enanthate is associated with an increased risk of postnatal depression. It and other long-acting progestogen contraceptives should be used with caution in the postnatal period, especially in women with a history of depression. The role of progesterone in the prevention and treatment of postnatal depression has yet to be evaluated in a randomised placebo-controlled trial. Oestrogen therapy may be of modest value at a late stage of severe postnatal depression. Its role in the prevention of recurrent postnatal depression has not been evaluated. Further research on its value is unlikely for ethical reasons.

Database of patients' experiences (DIPEx): a multi-media approach to sharing experiences and information.

The Database of Individual Patients' Experience of illness (DIPEx) is a multimedia website and CD-ROM that links patients' experiences with evidence-based information about treatments and the illness itself and with a range of other resources that may be useful, including support groups and links to other websites. DIPEx aims to identify the questions that matter to people when they are ill and it has potential for informing patients, educating healthcare professionals, and providing a patient-centred perspective to researchers and those who manage health services.

Towards a broader agenda for training in critical appraisal.

Much progress has been made in recent years towards an evidence-based approach to health care, i.e. the routine framing of an explicit decision sequence in the clinical encounter, the systematic search for published evidence, and the appraisal of relevant research articles. We argue that this is a commendable but limited milestone, and that training in evidence-based health care, particularly the use of critical appraisal techniques, is in need of a broader agenda. We outline a proposal through which the skills and attitudes needed for the critical appraisal of published articles may be applied to all other aspects of clinical practice, from planning research projects to presenting results and guidelines and peer review of articles submitted for publication.