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A Mixed Methods Exploration of Homeopathy for Attention Deficit

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A Mixed Methods Exploration of Homeopathy for Attention Deficit A Mixed Methods Exploration of Homeopathy for Attention Deficit Hyperactivity Disorder: Comparing Research Evidence and Clinical Practice Morag K. Heirs Doctor of Philosophy University of York Department of Health Sciences January 2012 Abstract Background: Complementary and alternative medicine is increasingly evaluated from an evidence-based medicine perspective which includes clinical trials. It was unclear to what extent these trials represented clinical practice and assessed treat- ments as given in the real world. Attention deficit hyperactivity disorder (ADHD) and homeopathy were explored as an exemplar comparing clinical trials versus daily practice. Objectives: Evaluate, contrast and compare the homeopathy as practiced within research trials with the approach adopted by practitioners in their daily prac- tice as a treatment for children diagnosed with ADHD. Methods: An explicitly mixed- methods approach based in Grounded Theory spanning quantitative and qualitative research techniques was adopted for this project. Data elements included a sys- tematic review, individual patient data meta-analysis, practitioner survey, in-depth interviews and participant-observation. Each method was rigorously implemented and analysed according to best practice; the results were then synthesised to deve- lop an explanatory model. Results & Conclusions: Although meta-analyses suggest there is little reliable evidence in favour of homeopathy for the treatment of ADHD, the trials conducted to date do not appear to have reflected clinical practice within the UK. The diversity of practice observed presents unique challenges for resear- chers who wish to improve the evidence base. A model of homeopathy as a process of individualisation is offered as a starting point for documenting observational stu- dies and developing realistic evaluations, and an outline of a future comparative trial is provided. Contents 1 Introduction and Background 1 1.1 Evidence-Based Medicine . .1 1.1.1 Origin and definition . .1 1.1.2 Benefits, challenges and implementation . .4 1.1.3 Summary . .6 1.2 Complementary/Alternative Medicine . .6 1.2.1 Defining complementary/alternative medicine . .6 1.2.2 Prevalence of CAM use in general . .8 1.2.3 Reasons for using CAMs . .9 1.2.4 EBM and CAM . 10 1.2.5 Summary . 11 1.3 Homeopathy . 12 1.3.1 Definitions and descriptions . 12 1.3.2 The practice of homeopathy . 13 1.3.3 Prevalence and reasons for homeopathy use . 14 1.3.4 Summary . 16 1.4 Attention Deficit/Hyperactivity Disorder . 16 iii 1.4.1 Diagnosis . 16 1.4.2 Living with ADHD . 18 1.4.3 Treatments for ADHD . 20 1.4.4 Summary . 21 1.5 Complementary medicine and ADHD . 21 1.5.1 Reasons for CAM use . 21 1.5.2 Prevalence and range of treatments used . 22 1.5.3 Summary . 24 1.6 Research Aims and Objectives . 24 2 Methodology Overview 27 2.1 Epistemology . 27 2.2 Grounded Theory . 28 2.2.1 Grounded theory and mixed methods research . 29 2.2.2 Reflexivity and theoretical sensitivity . 31 2.2.3 Sampling . 35 2.2.4 Constant comparison . 36 2.2.5 Memo writing and keeping a research journal . 36 2.3 Choosing the research strategies . 36 2.3.1 Constraints and influences . 36 2.3.2 Systematic Review . 43 2.3.3 Individual Patient Data (IPD) analysis . 44 2.3.4 Mixed-methods . 47 2.4 Summary . 49 iv 3 Systematic Review: Aggregate Data 51 3.1 Research Aims . 51 3.2 Protocol development and registration . 51 3.3 Criteria for considering studies for inclusion . 52 3.3.1 Study design . 52 3.3.2 Population . 52 3.3.3 Interventions . 53 3.3.4 Outcome measures . 53 3.4 Searching the literature and retrieving the studies . 55 3.4.1 Search strategies and limits . 55 3.4.2 Databases and resources searched . 56 3.5 Selection of studies . 57 3.6 Data management and extraction . 58 3.7 Assessing risk of bias . 58 3.8 Data synthesis . 60 3.8.1 Estimates of treatment effect . 60 3.8.2 Sensitivity analyses . 61 3.8.3 Heterogeneity . 61 3.8.4 Publication bias . 62 3.9 Search results . 62 3.9.1 Effectiveness . 62 3.9.2 Safety . 63 3.10 Summary of included studies . 63 v 3.11 Detailed study characteristics . 66 3.12 Assessing the risk of bias in the included studies . 70 3.12.1 Sequence generation and allocation concealment . 70 3.12.2 Blinding . 71 3.12.3 Outcomes data . 71 3.13 Effectiveness results . 72 3.13.1 Parent Rated Outcomes . 73 3.13.2 Teacher Rated Outcomes . 76 3.13.3 Child Completed Outcomes . 77 3.14 Safety results . 78 3.15 Discussion . 79 4 Systematic Review: Individual Patient Data 81 4.1 Research Aims . 81 4.2 Protocol development . 83 4.3 Inclusion criteria . 83 4.4 Data requested . 84 4.4.1 Baseline variables . 84 4.4.2 Outcome variables . 85 4.5 Data Management . 85 4.6 Checking and cleaning procedures . 86 4.6.1 Preliminary checks . 86 4.6.2 Detection of duplicates . 86 4.6.3 Date consistency checks . 87 vi 4.6.4 Verifying integrity of randomisation . 87 4.6.5 Assessment of follow-up . 88 4.6.6 Summary of primary and secondary outcomes . 88 4.6.7 Check for excluded patients . 89 4.6.8 Check against main publication . 89 4.6.9 Verification of data . 89 4.7 Analysis plan . 89 4.7.1 Re-analysing and confirming trial data . 89 4.7.2 Frei - carry-over and period effects . 89 4.7.3 IPD Meta-analysis . 90 4.7.4 Heterogeneity . 91 4.8 Included studies . 91 4.9 Data received . 92 4.9.1 Frei 2005: . 92 4.9.2 Jacobs 2005: . ..
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