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1.  Explanatory models of adult patients with type 2 diabetes mellitus from urban centers of central Ethiopia 
BMC Research Notes  2016;9(1):441.
Background
Type 2 diabetes, which is increasing as a public health problem in the low resource settings of Africa has been associated with the high prevalence of micro-vascular complications and increasing levels of macro-vascular complications. There is evidence from the developed world that understanding patient perceptions of chronic illness is important to design effective strategies for helping patients manage these conditions. This study utilized Kleinman’s model to explore the illness perceptions of type 2 diabetes patients attending treatment in Addis Ababa and Butajira (Ethiopia) and better understand how they manage their illness.
Design
Qualitative interviews were conducted to elicit the explanatory models of purposively sampled type 2 diabetes patients attending treatment in three hospitals in central Ethiopia until saturation of key emerging themes was achieved. Analysis of interview transcripts was guided by Kleinman’s model.
Results
A total of 39 participants, 24 from Addis Ababa and the rest from Butajira took part in the study. This study revealed that patients’ explanatory models were informed by both the traditional and biomedical models with emotional distress evident in some of the participants. The traditional model seemed to reflect the strong religious and cultural influences for the majority of study participants. The findings also revealed that symptoms played significant roles in how patients viewed their illness including assessment of its severity. Most were uncertain about the cause of their illness, with those expressing certainty citing factors over which they believed they had little or no control. This may have contributed to the perceptions about the use of religious healing and traditional medicines in a complementary or alternative manner to the biomedical regimen which could affect their adherence to recommended regimens and their health outcomes.
Conclusion
This study suggests the need for a strong diabetes care program that is sensitive to patients’ experiences of their illness including emotional distress. Individuals providing the diabetes care should consider local and individual contexts and strive to make their approach patient-centered and engage active participation of patients. There appears to be a need for better training of health providers in different areas including health communications and the fundamentals of mental healthcare.
doi:10.1186/s13104-016-2248-3
PMCID: PMC5022171  PMID: 27623807
Type 2 diabetes; Explanatory models; Kleinman’s model; Ethiopia; Qualitative research; Addis Ababa; Butajira
2.  Systematic review and network meta-analysis of stroke prevention treatments in patients with atrial fibrillation 
Background
In the last 4 years, four novel oral anticoagulants have been developed as alternatives to warfarin and antiplatelet agents for stroke prevention in atrial fibrillation (AF) patients. The objective of this review was to estimate the comparative effectiveness of all antithrombotic treatments for AF patients.
Materials and methods
Data sources were Medline Ovid (1946 to October 2015), Embase Ovid (1980 to October 2015), and the Cochrane Central Register of Controlled Trials (CENTRAL, Issue 9, 2015). Randomized controlled trials of AF patients were selected if they compared at least two of the following: placebo, aspirin, aspirin and clopidogrel combination therapy, adjusted-dose warfarin (target international normalized ratio 2.0–3.0), dabigatran, rivaroxaban, apixaban, and edoxaban. Bayesian network meta-analyses were conducted for outcomes of interest (all stroke, ischemic stroke, myocardial infarction, overall mortality, major bleeding, and intracranial hemorrhage).
Results
Based on 16 randomized controlled trials of 96,826 patients, all oral anticoagulants were more effective than antiplatelet agents at reducing the risk of ischemic stroke and all strokes. Compared to warfarin, dabigatran 150 mg (rate ratio 0.65, 95% credible interval 0.52–0.82) and apixaban (rate ratio 0.82, 95% credible interval 0.69–0.97) reduced the risk of all strokes. Dabigatran 150 mg was also more effective than warfarin at reducing ischemic stroke risk (rate ratio 0.76, 95% credible interval 0.59–0.99). Aspirin, apixaban, dabigatran 110 mg, and edoxaban were associated with less major bleeding than warfarin.
Conclusion
All oral anticoagulants reduce the risk of stroke in AF patients. Some novel oral anticoagulants are associated with a lower stroke and/or major bleeding risk than warfarin. In addition to the safety and effectiveness of drug therapy, as reported in this study, individual treatment recommendations should also consider the patient’s underlying stroke and bleeding risk profile.
doi:10.2147/CPAA.S105165
PMCID: PMC4986689  PMID: 27570467
meta-analysis; cerebrovascular disorders/drug therapy; stroke prevention; platelet-aggregation inhibitors; atrial fibrillation/prevention and control
3.  Exploring approaches to patient safety: the case of spinal manipulation therapy 
Background
The purpose of this study was to gain insight into the current safety culture around the use of spinal manipulation therapy (SMT) by regulated health professionals in Canada and to explore perceptions of readiness for implementing formal mechanisms for tracking associated adverse events.
Methods
Fifty-six semi-structured telephone interviews were conducted with professional leaders and frontline practitioners in chiropractic, physiotherapy, naturopathy and medicine, all professions regulated to perform SMT in the provinces of Alberta and Ontario Canada. Interviews were digitally audio-recorded for verbatim transcription. Transcripts were entered into HyperResearch software for qualitative data analysis and were coded for both anticipated and emergent themes using the constant comparative method. A thematic, descriptive analysis was produced.
Results
The safety culture around SMT is characterized by substantial disagreement about its actual rather than putative risks. Competing intra- and inter-professional narratives further cloud the safety picture. Participants felt that safety talk is sometimes conflated with competition for business in the context of fee-for-service healthcare delivery by several professions with overlapping scopes of practice. Both professional leaders and frontline practitioners perceived multiple barriers to the implementation of an incident reporting system for SMT.
Conclusions
The established ‘measure and manage’ approach to patient safety is difficult to apply to care which is geographically dispersed and delivered by practitioners in multiple professions with overlapping scopes of practice, primarily in a fee-for-service model. Collaboration across professions on models that allow practitioners to share information anonymously and help practitioners learn from the reported incidents is needed.
doi:10.1186/s12906-016-1149-2
PMCID: PMC4890537  PMID: 27251398
Safety culture; Spinal manipulation; Chiropractic; Physiotherapy
4.  Making sense of “alternative”, “complementary”, “unconventional” and “integrative” medicine: exploring the terms and meanings through a textual analysis 
Background
Medical pluralism has flourished throughout the Western world in spite of efforts to legitimize Western biomedical healthcare as “conventional medicine” and thereby relegate all non-physician-related forms of healthcare to an “other” category. These “other” practitioners have been referred to as “unconventional”, “alternative” and “complementary”, among other terms throughout the past half century.
Methods
This study investigates the discourses surrounding the changes in the terms, and their meanings, used to describe unconventional medicine in North America. Terms identified by the literature as synonymous to unconventional medicine were searched using the Scopus database. A textual analysis following the method described by Kripendorff 2013 was subsequently performed on the five most highly-cited unconventional medicine-related peer-reviewed literature published between 1970 and 2013.
Results
Five commonly-used, unconventional medicine-related terms were identified. Authors using “complementary and alternative”, “complementary”, “alternative”, or “unconventional” tended to define them by what they are not (e.g., therapies not taught/used in conventional medicine, therapy demands not met by conventional medicine, and therapies that lack research on safety, efficacy and effectiveness). Authors defined “integrated/integrative” medicine by what it is (e.g., a new model of healthcare, the combining of both conventional and unconventional therapies, accounting for the whole person, and preventative maintenance of health). Authors who defined terms by “what is not” stressed that the purpose of conducting research in this area was solely to create knowledge. Comparatively, authors who defined terms by “what is” sought to advocate for the evidence-based combination of unconventional and conventional medicines. Both author groups used scientific rhetoric to define unconventional medical practices.
Conclusions
This emergence of two groups of authors who used two different sets of terms to refer to the concept of “unconventional medicine” may explain why some journals, practitioner associations and research/practice centres may choose to use both “what is not” and “what is” terms in their discourse to attract interest from both groups. Since each of the two groups of terms (and authors who use them) has different meanings and goals, the evolution of this discourse will continue to be an interesting phenomenon to explore in the future.
doi:10.1186/s12906-016-1111-3
PMCID: PMC4875612  PMID: 27206976
5.  Development and Preliminary Face and Content Validation of the “Which Health Approaches and Treatments Are You Using?” (WHAT) Questionnaires Assessing Complementary and Alternative Medicine Use in Pediatric Rheumatology 
PLoS ONE  2016;11(3):e0149809.
Objective
Complementary and alternative medicine (CAM) is commonly used by children with juvenile idiopathic arthritis (JIA), yet no validated questionnaires assess that use. The objective of this study was to develop child self- and parent proxy-report questionnaires assessing CAM use and to determine the face and content validity of the “Which Health Approaches and Treatments are you using?” (WHAT) questionnaires in pediatric rheumatology.
Methods
A sequential phased mixed methods approach was used to develop the questionnaires. A Delphi Survey of 126 experts followed by an interdisciplinary consensus conference of 14 stakeholders in CAM, general pediatrics and pediatric rheumatology was held to develop consensus on the content of the questionnaires using a nominal group technique. To determine face and content validity of the questionnaires, two groups, including (a) a purposive sample of 22 children with JIA 8 to 18 years and their parents from the Children’s Hospital of Eastern Ontario and the Hospital for Sick Children, and (b) 21 Canadian pediatric rheumatology experts, participated in interviews. Participants were independently asked about the goal, understandability and comprehensiveness of the WHAT questionnaires, as well as the relevance of items.
Results
Consensus was reached on 17 items of the WHAT questionnaires. The domains found to be relevant were child’s CAM use, factors associated with CAM use, perceived impact of CAM use, and communication about CAM. A total of 15 items in the parent proxy-report questionnaire and 13 items in the child report questionnaire showed adequate content validity.
Conclusions
Consensus was reached by experts on the content of a pediatric CAM questionnaire. Face and content validity testing and modifications made to the WHAT questionnaires have helped ensure adequate preliminary validity for use in pediatric rheumatology. This constitutes the basis for further testing of these questionnaires in pediatric rheumatology and for adaptation to other chronic diseases.
doi:10.1371/journal.pone.0149809
PMCID: PMC4786318  PMID: 26964088
7.  State-Space Grid Analysis: Applications for Clinical Whole Systems Complementary and Alternative Medicine Research 
Summary
This paper presents state space grids (SSGs) as a mathematically less intensive methodology for process-oriented research beyond traditional qualitative and quantitative approaches in whole systems of complementary and alternative medicine (WS-CAM). SSGs, originally applied in developmental psychology research, offer a logical, flexible, and accessible tool for capturing emergent changes in the temporal dynamics of patient behaviors, manifestations of resilience, and outcomes. The SSG method generates a two-dimensional visualization and quantification of the inter-relationships between variables on a moment-to-moment basis. SSGs can describe dyadic interactive behavior in real time and, followed longitudinally, allow evaluation of how change occurs over extended time periods. Practice theories of WS-CAM encompass the holistic health concept of whole-person outcomes, including nonlinear pathways to complex, multidimensional changes. Understanding how the patient as a living system arrives at these outcomes requires studying the process of healing, e.g., sudden abrupt worsening and/or improvements, ‘healing crises’, and ‘unstuckness’, from which the multiple inter-personal and intra-personal outcomes emerge. SSGs can document the indirect, emergent dynamic effects of interventions, transitional phases, and the mutual interaction of patient and environment that underlie the healing process. Two WS-CAM research exemplars are provided to demonstrate the feasibility of using SSGs in both dyadic and within-patient contexts, and to illustrate the possibilities for clinically relevant, process-focused hypotheses. This type of research has the potential to help clinicians select, modify and optimize treatment plans earlier in the course of care and produce more successful outcomes for more patients.
doi:10.1159/000335187
PMCID: PMC4720125  PMID: 22327549
State space grids; Dynamic systems; Interpersonal dynamics; Intrapersonal dynamics; Complementary and alternative medicine; Complex adaptive systems
8.  Supportive but “worried”: perceptions of naturopaths, homeopaths and Chinese medicine practitioners through a regulatory transition in Ontario, Canada 
Background
In line with recent World Health Organization recommendations, many jurisdictions are taking steps to regulate practitioners of traditional, complementary and alternative medicine (TCAM). Previous studies have examined TCAM practitioners’ generally-supportive views about professional regulation; however, little research has been conducted on TCAM practitioners’ experiences and perspectives amidst an active regulatory process. In 2006 and 2007, the province of Ontario, Canada announced it would grant self-regulatory status to three TCAM practitioner groups - homeopaths, naturopaths and Chinese medicine practitioners/acupuncturists.
Methods
In 2011 and 2012, part-way through each group’s regulatory process, we surveyed all practitioners from these three groups (n = 1047) that could be identified from public registries and professional associations. The data presented here are derived from the sub-sample of homeopaths (n = 234), naturopaths (n = 273) and Chinese medicine practitioners/acupuncturists (n = 181) who provided answers to an open-ended question about their opinions of the regulatory process at the end of the survey. An inductive, thematic analysis of qualitative survey responses was conducted.
Results
Survey responses affirmed a pro-regulatory stance across all groups, but revealed considerable ‘worry’ amongst practitioners as to how the regulations might be implemented. Four primary ‘worry-related’ themes emerged: a) regulation’s potential administrative and financial burden on practitioners; b) scope-related concerns; c) implementation of fair registration standards; and d) whether regulation might erode the groups’ distinctive worldviews. Some occupationally-specific concerns appeared related to each group’s particular stage of professionalization. Other ‘worries’ may be related to the relative marginality of TCAM practitioner groups within biomedically-dominant national health care systems, and the possibility that inter-professional hierarchies may be emerging between particular TCAM groups. Specific concerns around overlapping practice scopes between TCAM and other professions raised questions about the implementation of non-monopolistic regulatory models such as Ontario’s.
Conclusions
Overall, this study will help inform regulators and TCAM practitioner groups to navigate the unique challenge of regulating health care providers long excluded from national health care systems, who frequently work from within paradigms distinct from mainstream biomedicine.
doi:10.1186/s12906-015-0846-6
PMCID: PMC4561449  PMID: 26347222
Traditional complementary and alternative medicine regulation health practitioner professions
9.  Negotiating Consent: Exploring Ethical Issues when Therapeutic Massage Bodywork Practitioners Are Trained in Multiple Therapies 
Introduction
Obtaining informed consent from competent patients is essential to the ethical delivery of health care, including therapeutic massage and bodywork (TMB). The informed consent process used by TMB practitioners has not been previously studied. Little information is available about the practice of informed consent in a treatment-focused environment that may involve multiple decision points, use of multiple TMB therapies, or both.
Methods
As part of a larger study on the process of providing TMB therapy, 19 practitioners were asked about obtaining informed consent during practice. Qualitative description was used to analyze discussions of the consent process generally, and about its application when practitioners use multiple TMB therapies.
Results
Two main consent approaches emerged, one based on a general consent early in the treatment process, and a second ongoing consent process undertaken throughout the course of treatment. Both processes are constrained by how engaged a patient wants to be, and the amount of information and time needed to develop a truly informed consent.
Conclusions
An understanding-based consent process that accommodates an acknowledged information differential between the patient and practitioner, and that is guided by clearly delineated goals within a trust-based relationship, may be the most effective consent process under the conditions of real practice conditions.
PMCID: PMC4240696  PMID: 25452820
complementary therapies/methods; massage; musculoskeletal manipulations; consent; decision-making; qualitative research; clinical practice
10.  Pharmacy study of natural health product adverse reactions (SONAR): a cross-sectional study using active surveillance in community pharmacies to detect adverse events associated with natural health products and assess causality 
BMJ Open  2014;4(3):e003431.
Objectives
To investigate the rates and causality of adverse event(s) (AE) associated with natural health product (NHP) use, prescription drug use and concurrent NHP-drug use through active surveillance in community pharmacies.
Design
Cross-sectional study of screened patients.
Setting
10 community pharmacies across Alberta and British Columbia, Canada from 14 January to 30 July 2011.
Participants
The participating pharmacy staff screened consecutive patients, or agents of patients, who were dropping or picking up prescription medications.
Primary outcome measures
Patients were screened to determine the proportions of them using prescription drugs and/or NHPs, as well as their respective AE rates. All AEs reported by the screened patients who took a NHP, consented to, and were available for, a detailed telephone interview (14%) were adjudicated fully to assess for causality.
Results
Over a total of 105 pharmacy weeks and 1118 patients screened, 410 patients reported taking prescription drugs only (36.7%; 95% CI 33.9% to 39.5%), 37 reported taking NHPs only (3.3%; 95% CI 2.4% to 4.5%) and 657 reported taking prescription drugs and NHPs concurrently (58.8%; 95% CI 55.9% to 61.6%). In total, 54 patients reported an AE, representing 1.2% (95% CI 0.51% to 2.9%), 2.7% (95% CI 0.4% to 16.9%) and 7.3% (95% CI 5.6% to 9.6%) of each population, respectively. Compared with patients who reported using prescription drugs, the patients who reported using prescription drugs and NHPs concurrently were 6.4 times more likely to experience an AE (OR; 95% CI 2.52 to 16.17; p<0.001). Combined with data from Ontario, Canada, a national proportion was calculated, which found that 45.4% (95% CI 43.8% to 47.0%) of Canadians who visit community pharmacies take NHPs and prescription drugs concurrently, and of those, 7.4% (95% CI 6.3% to 8.8%) report an AE.
Conclusions
A substantial proportion of community pharmacy patients use prescription drugs and NHPs concurrently; these patients are at a greater risk of experiencing an AE. Active surveillance provides a means of detecting such AEs and collecting high-quality data on which causality assessment can be based.
doi:10.1136/bmjopen-2013-003431
PMCID: PMC3975764  PMID: 24682573
Complementary Medicine; Toxicology
11.  The role of natural health products (NHPs) in dietetic practice: results from a survey of Canadian dietitians 
Background
Registered dietitians (RDs) play a key role in disseminating information about nutrition and intervening in nutrition-related disorders in the Canadian context. Natural health products (NHPs) are increasingly associated with nutrition in patient and health professional discussions. For this study, NHPs were divided into three categories: nutritional supplements (NS); functional foods/nutraceuticals (FF/N); and herbal preparations (HP). The objective was to explore RDs’ perceptions about their professional roles and responsibilities with respect to three categories of natural health products (NHPs).
Methods
This research consisted of an on-line survey of registered dietitians (RDs) in Ontario.
Surveys were distributed electronically to all practicing RDs in Ontario by the College of Dietitians of Ontario. There were 558 survey respondents, a response rate of 20%.
Results
The vast majority of RDs reported being consulted by clients about all product categories (98% for NS; 94% for FF/N; 91% for HP), with RDs receiving the most frequent questions about NS and the least frequent about HP. 74% of RDs believed that NS are included within the current scope of practice, compared to 59% for FF/N and 14% for HP. Even higher numbers believed that these products should be included: 97% for NS, 91% for FF/N and 47% for HP. RDs who report personally ingesting FF/N and HP were significantly more likely to report that these products should be in the dietetic scope of practice. In contrast, RDs who provide one-on-one counselling services or group-level counselling/workshops were significantly less likely to believe HP should be in the dietetic scope of practice.
Conclusions
Opinions of RDs indicated that NS and FF/N (and possibly HP) fall within, or should fall within, RDs’ scope of practice. Opportunity exists for RDs to undertake a professional role with respect to NHPs. Policy clarification regarding RD roles is needed.
doi:10.1186/1472-6882-13-156
PMCID: PMC3703453  PMID: 23819488
Dietitians; Professional roles and responsibilities; Natural health products; Dietary supplements; Nutritional supplements; Functional foods; Nutraceuticals; Herbal preparations
13.  Exploring the Nature of Therapeutic Massage Bodywork Practice 
Background
Research on therapeutic massage bodywork (TMB) continues to expand, but few studies consider how research or knowledge translation may be affected by the lack of uniformly standardized competencies for most TMB therapies, by practitioner variability from training in different forms of TMB, or from the effects of experience on practice.
Purpose
This study explores and describes how TMB practitioners practice, for the purpose of improving TMB training, practice, and research.
Participants & Setting
19 TMB practitioners trained in multiple TMB therapies, in Alberta, Canada.
Research Design
Qualitative descriptive sub-analysis of interviews from a comprehensive project on the training and practice of TMB, focused on the delivery of TMB therapies in practice.
Results
Two broad themes emerged from the data: (1) every treatment is individualized, and (2) each practitioner’s practice of TMB therapies evolves. Individualization involves adapting treatment to the needs of the patient in the moment, based on deliberate and unconscious responses to verbal and nonverbal cues. Individualization starts with initial assessment and continues throughout the treatment encounter. Expertise is depicted as more nuanced and skilful individualization and treatment, evolved through experience, ongoing training, and spontaneous technique exploration. Practitioners consider such individualization and development of experience desirable. Furthermore, ongoing training and experience result in therapy application unique to each practitioner. Most practitioners believed they could not apply a TMB therapy without influence from other TMB therapies they had learned.
Conclusions
There are ramifications for research design, knowledge translation, and education. Few practitioners are likely able to administer treatments in the same way, and most would not like to practice without being able to individualize treatment. TMB clinical studies need to employ research methods that accommodate the complexity of clinical practice. TMB education should facilitate the maturation of practice skills and self-reflection, including the mindful integration of multiple TMB therapies.
PMCID: PMC3577637  PMID: 23481609
complementary therapies/methods; massage; musculoskeletal manipulations; clinical competence; decision-making; qualitative research; clinical practice
15.  Prescribing gabapentin off label: Perspectives from psychiatry, pain and neurology specialists 
Canadian Pharmacists Journal : CPJ  2012;145(6):280-284.e1.
Objective: The objective of the study was to explore the experiences of physicians prescribing gabapentin off label.
Methods: We used a case study approach to explore the experiences of physicians prescribing gabapentin for off-label indications. Semi-structured interviews were conducted with 10 physicians (psychiatry, pain and neurology specialists) in the Greater Toronto Area. Data were collected to the point of saturation of key themes and analyzed using interpretive content analysis.
Key findings: Key informants appeared to rely primarily on informal information from colleagues and meetings, putting into question the accuracy of their information about the potential off-label uses of gabapentin. Our findings suggest the need for more evidence-based information on off-label drug use.
Conclusion: There is a need for greater understanding of off-label prescribing practices as an important step toward improving rational prescribing and ultimately toward improving patient safety and health outcomes.
doi:10.3821/145.6.cpj280
PMCID: PMC3567599  PMID: 23509590
16.  Understanding the role of scientific evidence in consumer evaluation of natural health products for osteoarthritis an application of the means end chain approach 
Background
Over 30% of individuals use natural health products (NHPs) for osteoarthritis-related pain. The Deficit Model for the Public Understanding of Science suggests that if individuals are given more information (especially about scientific evidence) they will make better health-related decisions. In contrast, the Contextual Model argues that scientific evidence is one of many factors that explain how consumers make health-related decisions. The primary objective was to investigate how the level of scientific evidence supporting the efficacy of NHPs impacts consumer decision-making in the self-selection of NHPs by individuals with osteoarthritis.
Methods
The means-end chain approach to product evaluation was used to compare laddering interviews with two groups of community-dwelling Canadian seniors who had used NHPs to treat their osteoarthritis. Group 1 (n=13) had used only NHPs (glucosamine and/or chondroitin) with “high” scientific evidence of efficacy. Group 2 (n=12) had used NHPs (methylsulfonylmethane (MSM) and/or bromelain) with little or no scientific evidence supporting efficacy. Content analysis and generation of hierarchical value maps facilitated the identification of similarities and differences between the two groups.
Results
The dominant decision-making chains for participants in the two scientific evidence categories were similar. Scientific evidence was an important decision-making factor but not as important as the advice from health care providers, friends and family. Most participants learned about scientific evidence via indirect sources from health care providers and the media.
Conclusions
The Contextual Model of the public understanding of science helps to explain why our participants believed scientific evidence is not the most important factor in their decision to use NHPs to help manage their osteoarthritis.
doi:10.1186/1472-6882-12-198
PMCID: PMC3517436  PMID: 23107559
Natural health products; Decision-making; Means ends chain analysis; Osteoarthritis
18.  Study of Natural Health Product Adverse Reactions (SONAR): Active Surveillance of Adverse Events Following Concurrent Natural Health Product and Prescription Drug Use in Community Pharmacies 
PLoS ONE  2012;7(9):e45196.
Background
Many consumers use natural health products (NHPs) concurrently with prescription medications. As NHP-related harms are under-reported through passive surveillance, the safety of concurrent NHP-drug use remains unknown. To conduct active surveillance in participating community pharmacies to identify adverse events related to concurrent NHP-prescription drug use.
Methodology/Principal Findings
Participating pharmacists asked individuals collecting prescription medications about (i) concurrent NHP/drug use in the previous three months and (ii) experiences of adverse events. If an adverse event was identified and if the patient provided written consent, a research pharmacist conducted a guided telephone interview to gather additional information after obtaining additional verbal consent and documenting so within the interview form. Over a total of 112 pharmacy weeks, 2615 patients were screened, of which 1037 (39.7%; 95% CI: 37.8% to 41.5%) reported concurrent NHP and prescription medication use. A total of 77 patients reported a possible AE (2.94%; 95% CI: 2.4% to 3.7%), which represents 7.4% of those using NHPs and prescription medications concurrently (95%CI: 6.0% to 9.2%). Of 15 patients available for an interview, 4 (26.7%: 95% CI: 4.3% to 49.0%) reported an AE that was determined to be “probably” due to NHP use.
Conclusions/Significance
Active surveillance markedly improves identification and reporting of adverse events associated with concurrent NHP-drug use. Although not without challenges, active surveillance is feasible and can generate adverse event data of sufficient quality to allow for meaningful adjudication to assess potential harms.
doi:10.1371/journal.pone.0045196
PMCID: PMC3461007  PMID: 23028841
19.  Investigating clinical heterogeneity in systematic reviews: a methodologic review of guidance in the literature 
Background
While there is some consensus on methods for investigating statistical and methodological heterogeneity, little attention has been paid to clinical aspects of heterogeneity. The objective of this study is to summarize and collate suggested methods for investigating clinical heterogeneity in systematic reviews.
Methods
We searched databases (Medline, EMBASE, CINAHL, Cochrane Library, and CONSORT, to December 2010) and reference lists and contacted experts to identify resources providing suggestions for investigating clinical heterogeneity between controlled clinical trials included in systematic reviews. We extracted recommendations, assessed resources for risk of bias, and collated the recommendations.
Results
One hundred and one resources were collected, including narrative reviews, methodological reviews, statistical methods papers, and textbooks. These resources generally had a low risk of bias, but there was minimal consensus among them. Resources suggested that planned investigations of clinical heterogeneity should be made explicit in the protocol of the review; clinical experts should be included on the review team; a set of clinical covariates should be chosen considering variables from the participant level, intervention level, outcome level, research setting, or others unique to the research question; covariates should have a clear scientific rationale; there should be a sufficient number of trials per covariate; and results of any such investigations should be interpreted with caution.
Conclusions
Though the consensus was minimal, there were many recommendations in the literature for investigating clinical heterogeneity in systematic reviews. Formal recommendations for investigating clinical heterogeneity in systematic reviews of controlled trials are required.
doi:10.1186/1471-2288-12-111
PMCID: PMC3564789  PMID: 22846171
20.  Measurement Properties of Questionnaires Assessing Complementary and Alternative Medicine Use in Pediatrics: A Systematic Review 
PLoS ONE  2012;7(6):e39611.
Objective
Complementary and alternative medicine (CAM) is commonly used by children, but estimates of that use vary widely partly due to the range of questionnaires used to assess CAM use. However, no studies have attempted to appraise measurement properties of these questionnaires. The aim of this systematic review was to critically appraise and summarize measurement properties of questionnaires of CAM use in pediatrics.
Study design
A search strategy was implemented in major electronic databases in March 2011 and conference websites, scientific journals and experts were consulted. Studies were included if they mentioned a questionnaire assessing the prevalence of CAM use in pediatrics. Members of the team independently rated the methodological quality of the studies (using the COSMIN checklist) and measurement properties of the questionnaires (using the Terwee and Cohen criteria).
Results
A total of 96 CAM questionnaires were found in 104 publications. The COSMIN checklist showed that no studies reported adequate methodological quality. The Terwee criteria showed that all included CAM questionnaires had indeterminate measurement properties. According to the Cohen score, none were considered to be a well-established assessment, two approached the level of a well-established assessment, seven were promising assessments and the remainder (n = 87) did not reach the score’s minimum standards.
Conclusion
None of the identified CAM questionnaires have been thoroughly validated. This systematic review highlights the need for proper validation of CAM questionnaires in pediatrics, which may in turn lead to improved research and knowledge translation about CAM in clinical practice.
doi:10.1371/journal.pone.0039611
PMCID: PMC3387262  PMID: 22768098
21.  An empirical study using permutation-based resampling in meta-regression 
Systematic Reviews  2012;1:18.
Background
In meta-regression, as the number of trials in the analyses decreases, the risk of false positives or false negatives increases. This is partly due to the assumption of normality that may not hold in small samples. Creation of a distribution from the observed trials using permutation methods to calculate P values may allow for less spurious findings. Permutation has not been empirically tested in meta-regression. The objective of this study was to perform an empirical investigation to explore the differences in results for meta-analyses on a small number of trials using standard large sample approaches verses permutation-based methods for meta-regression.
Methods
We isolated a sample of randomized controlled clinical trials (RCTs) for interventions that have a small number of trials (herbal medicine trials). Trials were then grouped by herbal species and condition and assessed for methodological quality using the Jadad scale, and data were extracted for each outcome. Finally, we performed meta-analyses on the primary outcome of each group of trials and meta-regression for methodological quality subgroups within each meta-analysis. We used large sample methods and permutation methods in our meta-regression modeling. We then compared final models and final P values between methods.
Results
We collected 110 trials across 5 intervention/outcome pairings and 5 to 10 trials per covariate. When applying large sample methods and permutation-based methods in our backwards stepwise regression the covariates in the final models were identical in all cases. The P values for the covariates in the final model were larger in 78% (7/9) of the cases for permutation and identical for 22% (2/9) of the cases.
Conclusions
We present empirical evidence that permutation-based resampling may not change final models when using backwards stepwise regression, but may increase P values in meta-regression of multiple covariates for relatively small amount of trials.
doi:10.1186/2046-4053-1-18
PMCID: PMC3351721  PMID: 22587815
22.  Pharmacists and Natural Health Products: A systematic analysis of professional responsibilities in Canada 
Pharmacy practice  2008;6(1):33-42.
PURPOSE
Natural health products (natural health products) such as herbs, vitamins and homeopathic medicines are widely available in Canadian pharmacies. The purpose of this paper was to conduct a systematic analysis of Canadian pharmacy policies and guidelines to explore pharmacists’ professional responsibilities with respect to natural health products.
METHODS
Legislation, codes of ethics, standards of practice and guidance documents that apply to the practice of pharmacy in each Canadian jurisdiction were systematically collected and examined to identify if, and how, these instruments establish professional duties in regard to natural health products.
RESULTS
The majority of Canadian jurisdictions now include some explicit reference to natural health products in standards of practice policy or guideline documents. Often natural health products are simply assumed to be included in the over-the-counter (OTC) product category and thus professional responsibilities for OTCs are relevant for natural health products. A minority of provinces have specific policies on natural health products, herbals or homeopathy. In addition, the National Association of Pharmacy Regulatory Authorities’ Model Standards of Practice specifically refers to natural health products. Most policy documents indicate that pharmacists should inquire about natural health product use when counselling patients and, when asked, should provide accurate information regarding the efficacy, toxicity, side effects or interactions of natural health products. Public messaging also indicates that pharmacists are knowledgeable professionals who can provide evidence-based information about natural health products.
CONCLUSIONS
Explicit policies or guidelines regarding pharmacists’ professional responsibilities with respect to natural health products currently exist in the majority of Canadian jurisdictions.
PMCID: PMC3265537  PMID: 22282720 CAMSID: cams1356
pharmacist; legal responsibilities; natural health products; dietary supplements
23.  Meaning and challenges in the practice of multiple therapeutic massage modalities: a combined methods study 
Background
Therapeutic massage and bodywork (TMB) practitioners are predominantly trained in programs that are not uniformly standardized, and in variable combinations of therapies. To date no studies have explored this variability in training and how this affects clinical practice.
Methods
Combined methods, consisting of a quantitative, population-based survey and qualitative interviews with practitioners trained in multiple therapies, were used to explore the training and practice of TMB practitioners in Alberta, Canada.
Results
Of the 5242 distributed surveys, 791 were returned (15.1%). Practitioners were predominantly female (91.7%), worked in a range of environments, primarily private (44.4%) and home clinics (35.4%), and were not significantly different from other surveyed massage therapist populations. Seventy-seven distinct TMB therapies were identified. Most practitioners were trained in two or more therapies (94.4%), with a median of 8 and range of 40 therapies. Training programs varied widely in number and type of TMB components, training length, or both. Nineteen interviews were conducted. Participants described highly variable training backgrounds, resulting in practitioners learning unique combinations of therapy techniques. All practitioners reported providing individualized patient treatment based on a responsive feedback process throughout practice that they described as being critical to appropriately address the needs of patients. They also felt that research treatment protocols were different from clinical practice because researchers do not usually sufficiently acknowledge the individualized nature of TMB care provision.
Conclusions
The training received, the number of therapies trained in, and the practice descriptors of TMB practitioners are all highly variable. In addition, clinical experience and continuing education may further alter or enhance treatment techniques. Practitioners individualize each patient's treatment through a highly adaptive process. Therefore, treatment provision is likely unique to each practitioner. These results may be of interest to researchers considering similar practice issues in other professions. The use of a combined-methods design effectively captured this complexity of TMB practice. TMB research needs to consider research approaches that can capture or adapt to the individualized nature of practice.
doi:10.1186/1472-6882-11-75
PMCID: PMC3187727  PMID: 21929823
24.  Mothers’ beliefs about analgesia during childhood immunization 
Paediatrics & Child Health  2010;15(5):289-293.
BACKGROUND:
Immunization injections are the most common painful medical procedures experienced during childhood, yet there is a discrepancy between recommendations for the effective use of topical anesthetics to reduce vaccine injection pain and actual practice.
OBJECTIVE:
To improve our understanding of mothers’ experiences and practices regarding their children’s routine immunizations.
METHOD:
Adopting an interpretive, naturalistic paradigm, semi-structured interviews were conducted with 15 mothers to examine their perceptions and experiences of their children’s immunization pain and pain management.
RESULTS:
The findings demonstrated three main themes: attitudes toward immunization pain, immunization pain management and physicians as sources of information. Participants described feeling distressed while their children were being immunized, but most managed these difficulties by focusing on the benefits of immunization and by minimizing or justifying the pain. All of the participants used non-pharmacological techniques to manage immunization injection pain. Few mothers were aware of the availability of topical anesthetics. When participants did use pharmacological analgesic approaches, oral analgesics were most likely to be used for prophylaxis and treatment of fever, and participants were unaware of evidence-based approaches to managing pain. Participants viewed their physicians as trusted sources of information, and the majority said that they would likely use a topical anesthetic in the future if recommended or approved by their physician.
CONCLUSION:
The present findings provide direction for future knowledge translation activities to enhance the knowledge of mothers and clinicians regarding pain during immunization injections and its effective management.
PMCID: PMC2912630  PMID: 21532793
Child; Immunization; Infant; Pain management; Qualitative research; Topical anesthetics
25.  Ginkgo biloba for the treatment of vitilgo vulgaris: an open label pilot clinical trial 
Background
Vitiligo is a common hypopigmentation disorder with significant psychological impact if occurring before adulthood. A pilot clinical trial to determine the feasibility of an RCT was conducted and is reported here.
Methods
12 participants 12 to 35 years old were recruited to a prospective open-label pilot trial and treated with 60 mg of standardized G. biloba two times per day for 12 weeks. The criteria for feasibility included successful recruitment, 75% or greater retention, effectiveness and lack of serious adverse reactions. Effectiveness was assessed using the Vitiligo Area Scoring Index (VASI) and the Vitiligo European Task Force (VETF), which are validated outcome measures evaluating the area and intensity of depigmentation of vitiligo lesions. Other outcomes included photographs and adverse reactions. Safety was assessed by serum coagulation factors (platelets, PTT, INR) at baseline and week 12.
Results
After 2 months of recruitment, the eligible upper age limit was raised from 18 to 35 years of age in order to facilitate recruitment of the required sample size. Eleven participants completed the trial with 85% or greater adherence to the protocol. The total VASI score improved by 0.5 (P = 0.021) from 5.0 to 4.5, range of scale 0 (no depigmentation) to 100 (completely depigmented). The progression of vitiligo stopped in all participants; the total VASI indicated an average repigmentation of vitiligo lesions of 15%. VETF total vitiligo lesion area decreased 0.4% (P = 0.102) from 5.9 to 5.6 from baseline to week 12. VETF staging score improved by 0.7 (P = 0.101) from 6.6 to 5.8, and the VETF spreading score improved by 3.9 (P < 0.001)) from 2.7 to -1.2. There were no statistically significant changes in platelet count, PTT, or INR.
Conclusions
The criteria for feasibility were met after increasing the maximum age limit of the successful recruitment criterion; participant retention, safety and effectiveness criteria were also met. Ingestion of 60 mg of Ginkgo biloba BID was associated with a significant improvement in total VASI vitiligo measures and VETF spread, and a trend towards improvement on VETF measures of vitiligo lesion area and staging. Larger, randomized double-blind clinical studies are warranted and appear feasible.
Trial Registration
Clinical trials.gov registration number NCT00907062
doi:10.1186/1472-6882-11-21
PMCID: PMC3065445  PMID: 21406109

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