User-perceived effectiveness and safety of paediatric complementary and alternative medicines: perspectives from international, British and local Scottish outcomes studies.
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NDU, O.O. 2015. User-perceived effectiveness and safety of paediatric complementary and alternative medicines: perspectives from international, British and local Scottish outcomes studies. Robert Gordon University, PhD thesis.
In the light of the current patient-centred approach to healthcare delivery, this research investigated the effectiveness and safety of paediatric complementary and alternative medicines (CAMs) from the users' perspective in order to generate suitable data to inform healthcare policy and planning. The research was in three parts: a systematic review (SR), a database analysis and a survey. The SR of papers published on the topic from 2000 to July 2011 identified 46 eligible studies conducted predominantly in the USA (14; 30%); with only 5 UK studies (11%), of which 2 were Scottish. Generally, their findings indicated a high report of positive health outcomes by CAM users, and a low report of adverse outcomes. Critical appraisal, however, highlighted the low methodological quality of most studies; with an overall quality rating of 45%, and only 9 studies (20%) possessing up to 8 of 12 quality indices. A tendency towards selective outcome reporting bias was also observed. The database research explored the suspected adverse reactions (ADRs) associated with paediatric use of natural health products (NHPs) as reported on the Yellow Card Scheme (YCS) from its inception until July 2012. The YCS data was mined to estimate the frequency and seriousness of the ADRs reported. NHPs were found to have contributed <1% of ADR reports within the period, with paediatric subjects contributing 8.6% of NHP reports (192 reports). These profiled 332 specific ADRs, 30% of which were described as serious. Female subjects contributed marginally more ADRs than males (51.5%). Rash and other skin and subcutaneous disorders were the most common ADRs. Herb-drug combination products were found to generate the most ADRs, with the senna-piperazine combination being the most frequently reported (89 ADRs). The product most associated with fatalities was soybean oil (5 reports). Generally, however, NHP-related ADRs reported for paediatric subjects in the YCS were found to be relatively few, and of low severity (6%) and fatality (2%); with over 75% resolution, and mostly within 3 days (68%). The survey component of the research was a bi-modal analytic cross-sectional survey of parents in Aberdeen, and aimed to determine the nature and demography of the use and user-reported outcomes of CAM among children in Aberdeen. Consenting parents recruited from the general population were invited to complete online or paper versions of a validated questionnaire. 212 parents of 391 children completed the survey, of which 143 reported CAM use in their children (67.5%). Participants were mainly mothers (73.6%); Caucasian (84.4%); aged 30-44 years (59.7%); and educated beyond secondary level (85.3%). 213 children had ever used CAM, 64.3% of which had always used CAM; while 21.1% had only used CAM within the last 12 months, and 14.6% had used it only previously. 53.1% of child CAM users were female. Parental self CAM use was found to be the strongest predictor of paediatric CAM use. 102 of the 123 parents that rated their children's CAM use (82.9%) perceived them as helpful; 76 of which said they helped 'a lot'. Finding personal CAM use helpful was the only factor found to significantly predict perceived effectiveness for paediatric CAM use. 9 parents reported adverse outcomes, mainly allergic skin reactions. In all, this research featured the first SR of user-perceived effectiveness and safety outcomes of paediatric CAMs; the first analysis of NHP-associated ADR reports on the YCS; and the first population-based Scottish study of paediatric CAM use. A triangulation of the results from these three strands validated the key finding that CAM is used widely among children, with high perceived effectiveness and safety outcomes. The implications of this finding for healthcare policy and planning were highlighted.