Denise Adams

Core Outcome Measures in Effectiveness Trials (COMET) initiative: protocol for an international Delphi study to achieve consensus on how to select outcome measurement instruments for outcomes included in a ‘core outcome set’

BackgroundThe Core Outcome Measures in Effectiveness Trials (COMET) initiative aims to facilitate the development and application of ‘core outcome sets’ (COS). A COS is an agreed minimum set of outcomes that should be measured and reported in all clinical trials of a specific disease or trial population. The overall aim of the Core Outcome Measurement Instrument Selection (COMIS) project is to develop a guideline on how to select outcome measurement instruments for outcomes included in a COS. As part of this project, we describe our current efforts to achieve a consensus on the methods for selecting outcome measurement instruments for outcomes to be included in a COS.Methods/DesignA Delphi study is being performed by a panel of international experts representing diverse stakeholders with the intention that this will result in a guideline for outcome measurement instrument selection. Informed by a literature review, a Delphi questionnaire was developed to identify potentially relevant tasks on instrument selection. The Delphi study takes place in a series of rounds. In the first round, panelists were asked to rate the importance of different tasks in the selection of outcome measurement instruments. They were encouraged to justify their choices and to add other relevant tasks. Consensus was reached if at least 70% of the panelists considered a task ‘highly recommended’ or ‘desirable’ and if no opposing arguments were provided. These tasks will be included in the guideline. Tasks that at least 50% of the panelists considered ‘not relevant’ will be excluded from the guideline. Tasks that were indeterminate will be taken to the second round. All responses of the first round are currently being aggregated and will be fed back to panelists in the second round. A third round will only be performed if the results of the second round require it.DiscussionSince the Delphi method allows a large group of international experts to participate, we consider it to be the preferred consensus-based method for our study. Based upon this consultation process, a guideline will be developed on instrument selection for outcomes to be included in a COS.

Complementary and Alternative Medicine Use by Pediatric Specialty Outpatients

OBJECTIVE: Complementary and alternative medicine (CAM) use is high among children and youth with chronic illnesses. The objective of this study was to assess the prevalence and patterns of CAM use in 10 subspecialty clinics in Canada and to compare CAM use between 2 geographically diverse locations. METHODS: This survey was carried out at 1 Children’s Hospital in western Canada (Edmonton) and 1 Children’s Hospital in central Canada (Ottawa). Questionnaires were completed by parents in either French or English. RESULTS: Although demographic characteristics of the 2 populations were similar, CAM use at the western hospital was 71% (n = 704) compared with 42% (n = 222) at the central hospital (P < .0001). Most respondents agreed or strongly agreed that they feel comfortable discussing CAM in their clinic. The most common CAM products currently used were multivitamins/minerals, herbal products, and homeopathic remedies. The most common CAM practices currently used were massage, chiropractic, relaxation, and aromatherapy. Eighty adverse effects were reported, and 55 (68.8%) of these were self-assessed as minor. CONCLUSIONS: Results of this study indicate that CAM use is high among pediatric specialty clinic outpatients and is much greater in the western than in the central hospital. Most respondents felt that their CAM use was helpful with few or no harms associated. Many patients, using CAM alongside their conventional medicines, are still not discussing their CAM use with their physicians and are increasing the likelihood for potential interactions and preventable harms.

Systematic reviews of TCM trials: how does inclusion of Chinese trials affect outcome?

Aim: Systematic reviews (SRs) are an important tool for the synthesis of research and are used to guide both research and clinical practice. Previous research suggests that changes to standard SR methodology may be warranted. The objectives of this study were to determine the value of adding Chinese‐language databases to conventional systematic review (SR) search strategies, and ii) to determine the importance of methodological validation of TCM RCTs in the conduct of SRs of two health conditions, chronic fatigue syndrome (CFS) and EBV‐infectious mononucleosis (mono).

CAM Use in Pediatric Neurology: An Exploration of Concurrent Use with Conventional Medicine

Background Previous studies have found that up to 60% of children with neurologic conditions have tried complementary and alternative medicine (CAM). Objective To assess the use of CAM among patients presenting to neurology clinics at two academic centers in Canada. Methods A survey instrument was developed to inquire about use of CAM products and therapies, including reasons for use, perceived helpfulness, and concurrent use with conventional medicine, and administered to patients or their parents/guardians at the Stollery Childrens Hospital in Edmonton and the Childrens Hospital of Eastern Ontario (CHEO) in Ottawa. Results Overall CAM use at the Stollery was 78%, compared to 48% at CHEO. The most common CAM products used were multi-vitamins (84%), vitamin C (37%), homeopathic remedies (24%), and fish oil/omega 3 s (22%). The most common CAM practices used were massage (47%), chiropractic (37%), faith healing (18%), aromatherapy (16%), homeopathy (16%), and relaxation (16%). Many patients used CAM products at the same time as conventional medicine but just over half (57%) discussed this concurrent use with their physician. Conclusion CAM use is common in pediatric neurology patients and most respondents felt that it was helpful, with few or no harms associated. However, this use is often undisclosed, increasing possibility of interactions with conventional drugs. We urge clinicians to inquire about CAM use during routine history taking at every patient visit. Parents would clearly like more information about CAM from their specialty clinics; such information would be easier to share if more primary data were available about the safety and effectiveness of commonly used therapies.

Patterns of utilization of complementary and alternative medicine in 2 pediatric gastroenterology clinics.

Objectives: The aim of the present study was to assess the prevalence and patterns of complementary and alternative medicine (CAM) use among pediatric patients with gastrointestinal (GI) disorders at academic clinics in Canada. Methods: The survey was carried out at 2 hospital-based gastroenterology clinics: the Stollery Childrens Hospital in Edmonton and the Childrens Hospital of Eastern Ontario (CHEO) in Ottawa. Results: CAM use at the Stollery was 83% compared with 36% at CHEO (P < 0.001). The most common reason for not using CAM was lack of knowledge about it. Most respondents felt comfortable discussing CAM in their clinic and wanted more information on CAM. The most common CAM products being taken were multivitamins (91%), calcium (35%), vitamin C (32%), probiotics (14%), and fish oil/omega-3 fatty acids (13%). The most common CAM practices being used were massage (43%), chiropractic (27%), faith healing (25%), and relaxation (18%). Most respondents believed that CAM was helpful, and most of the 23 reported adverse effects were minor. Seven were reported as moderate, and 3 were reported as severe. Many (42%) patients used CAM at the same time as prescription medicines, and of these patients, concurrent use was discussed with their physician (76%) or pharmacist (52%). Conclusions: CAM use is high among pediatric patients with GI disorders and is much greater among those in Edmonton than in Ottawa. Most respondents reported their CAM use as helpful, with little or no associated harm. Many patients fail to disclose their concurrent use of CAM and conventional medicines to their doctors, increasing the likelihood of interactions.

Complementary, Holistic, and Integrative Medicine: Autism Spectrum Disorder and Gluten- and Casein-Free Diet

On the basis of review of the published literature,limitations in current data do not support the use ofa gluten-free and casein-free diet (gfcf-d) asa primary autism spectrum disorder (ASD) treatment.(13)(25)(26)(36) On the basis of clinical opinion, given the popularity of parents seeking a gfcf-d for their children with ASD, clinicians should acknowledge family’s concerns and provide appropriate information about a gfcf-d toguide them and prevent possible harm.

CAM and Pediatric Oncology: Where Are All the Best Cases?

Background. Use of complementary and alternative medicine (CAM) by children with cancer is high; however, pediatric best cases are rare. Objectives. To investigate whether best cases exist in pediatric oncology using a three-phase approach and to compare our methods with other such programs. Methods. In phase I, Childrens Oncology Group (COG) oncologists were approached via email and asked to recall patients who were (i) under 18 when diagnosed with cancer, (ii) diagnosed between 1990 and 2006, (iii) had unexpectedly positive clinical outcome, and (iv) reported using CAM during or after cancer treatment. Phase II involved partnering with CAM research networks; patients who were self-identified as best cases were asked to submit reports completed in conjunction with their oncologists. Phase III extended this partnership to 200 CAM associations and training organizations. Results. In phase I, ten cases from three COG sites were submitted, and most involved use of traditional Chinese medicine to improve quality of life. Phases II and III did not yield further cases. Conclusion. Identification of best cases has been suggested as an important step in guiding CAM research. The CARE Best Case Series Program had limited success in identifying pediatric cases despite the three approaches we used.

Complementary, holistic, and integrative medicine: music for procedural pain.

1. Jaden Wright, MD* 2. Denise Adams, PhD* 3. Sunita Vohra, MD, MSc* 1. *University of Alberta, Edmonton, Alberta, Canada. Although potentially important for a patient’s well-being, many medical procedures, including routine immunizations, are painful. Insufficient pain control during procedures can produce long-term negative effects, especially in the very young. (1) Pharmacotherapy is used commonly to treat pediatric pain; however, because of concerns about adverse effects, (2,3,4) many health care professionals and patients are interested in using nonpharmacologic options as well as or in place of medications. One potential option is the use of music or music therapy during a painful procedure. The formal definition of music therapy is “the skillful use of music and musical elements by an accredited music therapist to promote, maintain, and restore mental, physical, emotional, and spiritual health.” (5) Pediatric research has investigated the effects of both music therapy, in which a music therapist administers the intervention (active music therapy), and simply playing prerecorded music for the participant (passive music therapy). This review summarizes the evidence from randomized controlled trials (RCTs) of the use of music to reduce procedural pain in pediatric patients. Because pain is closely related to anxiety and distress, these measures are included when provided. We will look first at older children and then at neonates subject to procedural pain. The use of music for alleviating pain and anxiety in children (excluding neonates younger than 1 month) was summarized in a 2008 systematic review of 19 RCTs (5 trials of active and 14 trials of passive music therapy) that included a total of 1513 participants, ages 8 months to 20 years, who were undergoing procedures, including oral surgery, venipuncture, elective surgery, intramuscular injections, magnetic resonance imaging, general anesthesia, colposcopy, bone …

P02.17. Building a database of validated pediatric outcomes: an investigation of compliance with established reporting standards

Purpose Many pediatric trials are published annually, but criticism exists regarding outcome measures used and their reporting. Reporting standards set out by the Consolidated Standards of Reporting Trials (CONSORT) group require accurately defined outcomes, and apply equally to studies of conventional or complementary and alternative medicine (CAM). The objective of this study was to conduct a systematic review to identify gaps in outcome reporting in pediatric randomized controlled trials (RCTs).