A Mixed Methods Exploration of Homeopathy for Attention Deficit Hyperactivity Disorder: Comparing Research Evidence and Clinical Practice

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 treatments 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 practice 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 systematic 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 develop 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 researchers 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 studies and developing realistic evaluations, and an outline of a future comparative trial is provided

Scaling the Tower of Babel. The impact of including foreign language articles in a large scale systematic review

Ideally systematic reviews should include all relevant evidence to answer a given research question. However, in practice there is a trade-off between budgetary and time constraints and the inclusion of studies in languages other than English (LOE). 1 Current guidance recommends identifying papers in LOE and giving consideration as to whether language restrictions may bias the results of the review. 1 An issue which does not appear to have been fully considered is how excluding papers in LOE from systematic reviews might impact on the credibility of the review in the eyes of stakeholders. We were commissioned to conduct a systematic review of photodynamic therapy (PDT) for the treatment of pre-cancerous skin conditions, Barrett’s oesophagus and cancers of the biliary tract, brain, head and neck, lung, oesophagus and skin. 2 PDT is a controversial topic area, often generating polarised opinions. The team needed to demonstrate their commitment to an objective, thorough, unbiased review of all the relevant evidence

Reporting of industry funded study outcome data:comparison of confidential and published data on the safety and effectiveness of rhBMP-2 for spinal fusion

Objective To investigate whether published results of industry funded trials of recombinant human bone morphogenetic protein 2 (rhBMP-2) in spinal fusion match underlying trial data by comparing three different data sources: individual participant data, internal industry reports, and publicly available journal publications and conference abstracts. Data collection and synthesis The manufacturer of rhBMP-2 products (Medtronic; Minneapolis, MN) provided complete individual participant data and internal reports for all its studies of rhMBP-2 in spinal fusion. We identified publications and conference abstracts through comprehensive literature searches. We compared outcomes provided in the individual participant data against outcomes reported in publications. For effectiveness outcomes, we compared meta-analyses of randomised controlled trials based on each of the three data sources. For adverse events, meta-analysis of the published aggregate data was not possible and we compared the number and type of adverse events reported between data sources. Results 32 publications reported outcomes from 11 of the 17 existing manufacturer sponsored studies. For individual randomised controlled trials, 56% (9/16) to 88% (15/17) of effectiveness outcomes known to have been collected were reported in the published literature. Meta-analyses of effectiveness data were almost identical for pain outcomes and similar for fusion across the three data sources. A minority of adverse event data known to have been collected were reported in the published literature. Several journal articles reported only “serious,” “related,” or “unanticipated” adverse events, without defining these terms. Others reported a small proportion of the collected adverse event categories. Around 23% (533/2302) of the total adverse events collected in published randomised controlled trials have been reported in the literature, with randomised controlled trials evaluating the licensed preparation (Infuse) reporting around 11% (122/1108) of collected adverse events. Conclusions The published literature only partially represents the total data known to have been collected on the effects of rhBMP-2. This did not lead to substantially different results for meta-analysis of effectiveness outcomes. In contrast, reporting of adverse event data in trial publications was inadequate and inconsistent to the extent that any systematic review based solely on the publicly available data would not be able to properly evaluate the safety of rhBMP-2. Analysis of individual participant data enabled the most complete, detailed, and in-depth analysis and was not more resource intensive than extracting, collating, and analysing aggregate data from multiple trial publications and conference abstracts. Confidential internal reports presented considerably more adverse event data than publications, and in the absence of individual participant data access to these reports would support more accurate and reliable investigation, with less time and effort than relying on incomplete published data

Defining Terms Used for Animals Working in Support Roles for People with Support Needs.

The nomenclature used to describe animals working in roles supporting people can be confusing. The same term may be used to describe different roles, or two terms may mean the same thing. This confusion is evident among researchers, practitioners, and end users. Because certain animal roles are provided with legal protections and/or government-funding support in some jurisdictions, it is necessary to clearly define the existing terms to avoid confusion. The aim of this paper is to provide operationalized definitions for nine terms, which would be useful in many world regions: "assistance animal", "companion animal", "educational/school support animal", "emotional support animal", "facility animal", "service animal", "skilled companion animal", "therapy animal", and "visiting/visitation animal". At the International Society for Anthrozoology (ISAZ) conferences in 2018 and 2020, over 100 delegates participated in workshops to define these terms, many of whom co-authored this paper. Through an iterative process, we have defined the nine terms and explained how they differ from each other. We recommend phasing out two terms (i.e., "skilled companion animal" and "service animal") due to overlap with other terms that could potentially exacerbate confusion. The implications for several regions of the world are discussed

Defining Terms Used for Animals Working in Support Roles for People with Support Needs

The nomenclature used to describe animals working in roles supporting people can be confusing. The same term may be used to describe different roles, or two terms may mean the same thing. This confusion is evident among researchers, practitioners, and end users. Because certain animal roles are provided with legal protections and/or government-funding support in some jurisdictions, it is necessary to clearly define the existing terms to avoid confusion. The aim of this paper is to provide operationalized definitions for nine terms, which would be useful in many world regions: “assistance animal”, “companion animal”, “educational/school support animal”, “emotional support animal”, “facility animal”, “service animal”, “skilled companion animal”, “therapy animal”, and “visiting/visitation animal”. At the International Society for Anthrozoology (ISAZ) conferences in 2018 and 2020, over 100 delegates participated in workshops to define these terms, many of whom co-authored this paper. Through an iterative process, we have defined the nine terms and explained how they differ from each other. We recommend phasing out two terms (i.e., “skilled companion animal” and “service animal”) due to overlap with other terms that could potentially exacerbate confusion. The implications for several regions of the world are discussed