METHODS: ClinicalTrials.gov was searched for all randomized, interventional, phase II-IV trials that were registered between 1 January 2000 and 31 December 2009 and included adults with Alzheimer's disease, motor neurone disease, multiple sclerosis or Parkinson's disease. Publications from these trials were identified by extensive online searching and contact with authors, and multiple logistic regression analysis was performed to identify characteristics associated with trial discontinuation and non-publication.
RESULTS: In all, 362 eligible trials were identified, of which 12% (42/362) were discontinued. 28% (91/320) of completed trials remained unpublished after 5 years. Trial discontinuation was independently associated with number of patients (P = 0.015; more likely in trials with ≤100 patients; odds ratio 2.65, 95% confidence interval 1.21-5.78) and phase of trial (P = 0.009; more likely in phase IV than phase III trials; odds ratio 3.90, 95% confidence interval 1.41-10.83). Trial non-publication was independently associated with blinding status (P = 0.005; more likely in single-blind than double-blind trials; odds ratio 5.63, 95% confidence interval 1.70-18.71), number of centres (P = 0.010; more likely in single-centre than multi-centre trials; odds ratio 2.49, 95% confidence interval 1.25-4.99), phase of trial (P = 0.041; more likely in phase II than phase IV trials; odds ratio 2.88, 95% confidence interval 1.04-7.93) and sponsor category (P = 0.001; more likely in industry-sponsored than university-sponsored trials; odds ratio 5.05, 95% confidence interval 1.87-13.63).
CONCLUSIONS: There is evidence of non-dissemination bias in randomized trials of interventions for neurodegenerative diseases. Associations with trial discontinuation and non-publication were similar to findings in other diseases. These biases may distort the therapeutic information available to inform clinical practice.
METHODS: This study is based on the collective and direct experiences of the founding members of the HTAsiaLink Network. Data were collected from presentations they made at various international forums and additional information was reviewed. Data analysis was done using the framework developed by San Martin-Rodriguez et al.Results and Conclusions:HTAsiaLink is a network of health technology assessment (HTA) agencies in Asia established in 2011 with the aim of strengthening individual and institutional HTA capacity, reducing duplication and optimizing resources, transfer and sharing of HTA-related lessons among members, and beyond. During its 6 years, the network has expanded, initiating several capacity building activities and joint-research projects, raising awareness of the importance of HTA within the region and beyond, and gaining global recognition while establishing relationships with other global networks. The study identifies the determinants of success of the collaboration. The systemic factors include the favorable outlook toward HTA as an approach for healthcare priority setting in countries with UHC mandates. On organizational factors, the number of newly established HTA agencies in the region with similar needs for capacity building and peer-to-peer support was catalytic for the network development. The interactional aspects include ownership, trust, and team spirit among network members. The network, however, faces challenges notably, financial sustainability and management of the expanded network.
DESIGN AND SETTING: Self-administered questionnaires (in English, Malay, or Chinese) were provided to customers at three community pharmacies in Malaysia (Ipoh, Perak). Questionnaire validation and translation validation were performed. A pilot study was conducted before actual questionnaire distribution. Informed consent was obtained from all participants.
RESULTS: Total number of participants was 270 (99 males and 171 females) with majority from the 31-50 age group (41.5%). Among the participants, 45.6% were herbal users. The most commonly used herbal supplements were evening primrose oil (17.9%), ginkgo biloba (13.0%), and milk thistle (8.5%). The participants seemed to have sufficient knowledge regarding herbal supplements including safety, quality, and indication of use from medical literature. Participants obtained information about herbal supplements from pharmacists (26.9%), package inserts (25.2%), friends (20.5%), and the Internet (13.3%) more often than from their doctors (9.8%). Most herbal users did not inform their doctors about their usage of herbal supplements (68.3%) or the side effects (61.5%). Herbal supplement users also tended to be women, >50-year-old, and those with higher monthly household incomes.
CONCLUSIONS: Community pharmacists have a vital role in educating their customers about the safe use of herbal supplements. The participants had sufficient knowledge about herbal supplement usage; therefore, customers of these community pharmacies may have benefitted from the advice of the pharmacists. Further studies could be carried out in future on the knowledge, skills and roles of community pharmacists in the safe use of herbal supplements.