Evaluating complementary and alternative medicine interventions: in search of appropriate patient-centered outcome measures

BACKGROUND: Central to the development of a sound evidence base for Complementary and Alternative Medicine (CAM) interventions is the need for valid, reliable and relevant outcome measures to assess whether the interventions work. We assessed the specific needs for a database that would cover a wide range of outcomes measures for CAM research and considered a framework for such a database. METHODS: The study was a survey of CAM researchers, practitioners and students. An online questionnaire was emailed to the members of the Canadian Interdisciplinary Network for CAM Research (IN-CAM) and the CAM Education and Research Network of Alberta (CAMera). The majority of survey questions were open-ended and asked about outcome measures currently used, outcome measures' assessment criteria, sources of information, perceived barriers to finding outcome measures and outcome domains of importance. Descriptive quantitative analysis and qualitative content analysis were used. RESULTS: One hundred and sixty-four completed surveys were received. Of these, 62 respondents reported using outcome measures in their CAM research and identified 92 different specific outcomes. The most important barriers were the fact that, for many health concepts, outcome measures do not yet exist, as well as issues related to accessibility of instruments. Important outcome domains identified included physical, psychological, social, spiritual, quality of life and holistic measures. Participants also mentioned the importance of individualized measures that assess unique patient-centered outcomes for each research participant, and measures to assess the context of healing and the process of healing. CONCLUSION: We have developed a preliminary framework that includes all components of health-related outcomes. The framework provides a foundation for a larger, comprehensive collection of CAM outcomes. It fits very well in a whole systems perspective, which requires an expanded set of outcome measures, such as individualized and holistic measures, with attention to issues of process and context

The age of anxiety? It depends where you look: changes in STAI trait anxiety, 1970–2010

Purpose Population-level surveys suggest that anxiety has been increasing in several nations, including the USA and UK. We sought to verify the apparent anxiety increases by looking for systematic changes in mean anxiety questionnaire scores from research publications. Methods We analyzed all available mean State–Trait Anxiety Inventory scores published between 1970 and 2010. We collected 1703 samples, representing more than 205,000 participants from 57 nations. Results Results showed a significant anxiety increase worldwide, but the pattern was less clear in many individual nations. Our analyses suggest that any increase in anxiety in the USA and Canada may be limited to students, anxiety has decreased in the UK, and has remained stable in Australia. Conclusions Although anxiety may have increased worldwide, it might not be increasing as dramatically as previously thought, except in specific populations, such as North American students. Our results seem to contradict survey results from the USA and UK in particular. We do not claim that our results are more reliable than those of large population surveys. However, we do suggest that mental health surveys and other governmental sources of disorder prevalence data may be partially biased by changing attitudes toward mental health: if respondents are more aware and less ashamed of their anxiety, they are more likely to report it to survey takers. Analyses such as ours provide a useful means of double-checking apparent trends in large population surveys

How Experiences Become Data: The Process of Eliciting Adverse Event, Medical History and Concomitant Medication Reports in Antimalarial and Antiretroviral Interaction Trials.

Accurately characterizing a drug's safety profile is essential. Trial harm and tolerability assessments rely, in part, on participants' reports of medical histories, adverse events (AEs), and concomitant medications. Optimal methods for questioning participants are unclear, but different methods giving different results can undermine meta-analyses. This study compared methods for eliciting such data and explored reasons for dissimilar participant responses. Participants from open-label antimalarial and antiretroviral interaction trials in two distinct sites (South Africa, n = 18 [all HIV positive]; Tanzania, n = 80 [86% HIV positive]) were asked about ill health and treatment use by sequential use of (1) general enquiries without reference to particular conditions, body systems or treatments, (2) checklists of potential health issues and treatments, (3) in-depth interviews. Participants' experiences of illness and treatment and their reporting behaviour were explored qualitatively, as were trial clinicians' experiences with obtaining participant reports. Outcomes were the number and nature of data by questioning method, themes from qualitative analyses and a theoretical interpretation of participants' experiences. There was an overall cumulative increase in the number of reports from general enquiry through checklists to in-depth interview; in South Africa, an additional 12 medical histories, 21 AEs and 27 medications; in Tanzania an additional 260 medical histories, 1 AE and 11 medications. Checklists and interviews facilitated recognition of health issues and treatments, and consideration of what to report. Information was sometimes not reported because participants forgot, it was considered irrelevant or insignificant, or they feared reporting. Some medicine names were not known and answers to questions were considered inferior to blood tests for detecting ill health. South African inpatient volunteers exhibited a "trial citizenship", working to achieve researchers' goals, while Tanzanian outpatients sometimes deferred responsibility for identifying items to report to trial clinicians. Questioning methods and trial contexts influence the detection of adverse events, medical histories and concomitant medications. There should be further methodological work to investigate these influences and find appropriate questioning methods

Rural Australian community pharmacists' views on complementary and alternative medicine: a pilot study

<p>Abstract</p> <p>Background</p> <p>Complementary and alternative medicines (CAMs) are being used increasingly across the world. In Australia, community pharmacists are a major supplier of these products but knowledge of the products and interactions with other medicines is poor. Information regarding the use of CAMs by metropolitan pharmacists has been documented by the National Prescribing Service (NPS) in Australia but the views of rural/regional community pharmacists have not been explored. The aim of this pilot study was to explore the knowledge, attitudes and information seeking of a cohort of rural community pharmacists towards CAMs and to compare the findings to the larger NPS study.</p> <p>Methods</p> <p>A cross sectional self-administered postal questionnaire was mailed to all community pharmacists in one rural/regional area of Australia. Using a range of scales, data was collected regarding attitudes, knowledge, information seeking behaviour and demographics.</p> <p>Results</p> <p>Eighty eligible questionnaires were returned. Most pharmacists reported knowing that they should regularly ask consumers if they are using CAMs but many lacked the confidence to do so. Pharmacists surveyed for this study were more knowledgeable in regards to side effects and interactions of CAMs than those in the NPS survey. Over three quarters of pharmacists surveyed reported sourcing CAM information at least several times a month. The most frequently sought information was drug interactions, dose, contraindications and adverse effects. A variety of resources were used to source information, the most popular source was the internet but the most useful resource was CAM text books.</p> <p>Conclusions</p> <p>Pharmacists have varied opinions on the use of CAMs and many lack awareness of or access to good quality CAMs information. Therefore, there is a need to provide pharmacists with opportunities for further education. The data is valuable in assisting interested stakeholders with the development of initiatives to address the gaps in attitudes, knowledge and to improve effectiveness of information seeking behaviour.</p