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1.  Safety and effectiveness of dipeptidyl peptidase-4 inhibitors versus intermediate-acting insulin or placebo for patients with type 2 diabetes failing two oral antihyperglycaemic agents: a systematic review and network meta-analysis 
BMJ Open  2014;4(12):e005752.
To evaluate the effectiveness and safety of dipeptidyl peptidase-4 (DPP-4) inhibitors versus intermediate-acting insulin for adults with type 2 diabetes mellitus (T2DM) and poor glycaemic control despite treatment with two oral agents.
Studies were multicentre and multinational.
Ten studies including 2967 patients with T2DM.
Studies that examined DPP-4 inhibitors compared with each other, intermediate-acting insulin, no treatment or placebo in patients with T2DM.
Primary and secondary outcome measures
Primary outcome was glycosylated haemoglobin (HbA1c). Secondary outcomes were healthcare utilisation, body weight, fractures, quality of life, microvascular complications, macrovascular complications, all-cause mortality, harms, cost and cost-effectiveness.
10 randomised clinical trials with 2967 patients were included after screening 5831 titles and abstracts, and 180 full-text articles. DPP-4 inhibitors significantly reduced HbA1c versus placebo in network meta-analysis (NMA; mean difference (MD) −0.62%, 95% CI −0.93% to −0.33%) and meta-analysis (MD −0.61%, 95% CI −0.81% to −0.41%), respectively. Significant differences in HbA1c were not observed for neutral protamine Hagedorn (NPH) insulin versus placebo and DPP-4 inhibitors versus NPH insulin in NMA. In meta-analysis, no significant differences were observed between DPP-4 inhibitors and placebo for severe hypoglycaemia, weight gain, cardiovascular disease, overall harms, treatment-related harms and mortality, although patients receiving DPP-4 inhibitors experienced less infections (relative risk 0.72, 95% CI 0.57 to 0.91).
DPP-4 inhibitors were superior to placebo in reducing HbA1c levels in adults with T2DM taking at least two oral agents. Compared with placebo, no safety signals were detected with DPP-4 inhibitors and there was a reduced risk of infection. There was no significant difference in HbA1c observed between NPH and placebo or NPH and DPP-4 inhibitors.
Trial registration number
PROSPERO # CRD42013003624.
PMCID: PMC4275675  PMID: 25537781
systematic review; meta-analysis
2.  Effectiveness of knowledge translation tools addressing multiple high-burden chronic diseases affecting older adults: protocol for a systematic review alongside a realist review 
BMJ Open  2015;5(2):e007640.
The burden of chronic disease is a global phenomenon, particularly among people aged 65 years and older. More than half of older adults have more than one chronic disease and their care is not optimal. Chronic disease management (CDM) tools have the potential to meet this challenge but they are primarily focused on a single disease, which fails to address the growing number of seniors with multiple chronic conditions.
Methods and analysis
We will conduct a systematic review alongside a realist review to identify effective CDM tools that integrate one or more high-burden chronic diseases affecting older adults and to better understand for whom, under what circumstances, how and why they produce their outcomes. We will search MEDLINE, EMBASE, CINAHL, AgeLine and the Cochrane Library for experimental, quasi-experimental, observational and qualitative studies in any language investigating CDM tools that facilitate optimal disease management in one or more high-burden chronic diseases affecting adults aged ≥65 years. Study selection will involve calibration of reviewers to ensure reliability of screening and duplicate assessment of articles. Data abstraction and risk of bias assessment will also be performed independently. Analysis will include descriptive summaries of study and appraisal characteristics, effectiveness of each CDM tool (meta-analysis if appropriate); and a realist programme theory will be developed and refined to explain the outcome patterns within the included studies.
Ethics and dissemination
Ethics approval is not required for this study. We anticipate that our findings, pertaining to gaps in care across high-burden chronic diseases affecting seniors and highlighting specific areas that may require more research, will be of interest to a wide range of knowledge users and stakeholders. We will publish and present our findings widely, and also plan more active dissemination strategies such as workshops with our key stakeholders.
Trial registration number
Our protocol is registered with PROSPERO (registration number CRD42014014489).
PMCID: PMC4322198  PMID: 25649215
3.  A usability study of two formats of a shortened systematic review for clinicians 
BMJ Open  2014;4(12):e005919.
The aim of this study was to evaluate the usability of two formats of a shortened systematic review for clinicians.
Materials and methods
Usability of the prototypes was assessed using three cycles of iterative testing. 10 participants were asked to complete tasks of locating information or items within two prototypes and ‘think aloud’ while being audio taped. Interviews were also audio recorded and participants completed a systematic usability scale.
Revisions were made between each iteration in order to address issues identified by participants. Finding information relating to the number of studies in the meta-analysis, and locating the number of studies in the entire systematic review were revealed as areas needing attention during the usability evaluation.
Iterative testing combined with a multifaceted approach to usability testing offered essential insight into aspects of the prototypes that required modifications. Alterations were made in order to create finalised versions of the two shortened systematic review formats.
PMCID: PMC4275680  PMID: 25537782
Review Literature as Topic; PRIMARY CARE; Evidence Based Practice
4.  A web-based intervention to support self-management of patients with type 2 diabetes mellitus: effect on self-efficacy, self-care and diabetes distress 
Management of diabetes mellitus is complex and involves controlling multiple risk factors that may lead to complications. Given that patients provide most of their own diabetes care, patient self-management training is an important strategy for improving quality of care. Web-based interventions have the potential to bridge gaps in diabetes self-care and self-management. The objective of this study was to determine the effect of a web-based patient self-management intervention on psychological (self-efficacy, quality of life, self-care) and clinical (blood pressure, cholesterol, glycemic control, weight) outcomes.
For this cohort study we used repeated-measures modelling and qualitative individual interviews. We invited patients with type 2 diabetes to use a self-management website and asked them to complete questionnaires assessing self-efficacy (primary outcome) every three weeks for nine months before and nine months after they received access to the website. We collected clinical outcomes at three-month intervals over the same period. We conducted in-depth interviews at study conclusion to explore acceptability, strengths and weaknesses, and mediators of use of the website. We analyzed the data using a qualitative descriptive approach and inductive thematic analysis.
Eighty-one participants (mean age 57.2 years, standard deviation 12) were included in the analysis. The self-efficacy score did not improve significantly more than expected after nine months (absolute change 0.12; 95% confidence interval −0.028, 0.263; p = 0.11), nor did clinical outcomes. Website usage was limited (average 0.7 logins/month). Analysis of the interviews (n = 21) revealed four themes: 1) mediators of website use; 2) patterns of website use, including role of the blog in driving site traffic; 3) feedback on website; and 4) potential mechanisms for website effect.
A self-management website for patients with type 2 diabetes did not improve self-efficacy. Website use was limited. Although its perceived reliability, availability of a blog and emailed reminders drew people to the website, participants’ struggles with type 2 diabetes, competing priorities in their lives, and website accessibility were barriers to its use. Future interventions should aim to integrate the intervention seamlessly into the daily routine of end users such that it is not seen as yet another chore.
Electronic supplementary material
The online version of this article (doi:10.1186/s12911-014-0117-3) contains supplementary material, which is available to authorized users.
PMCID: PMC4272538  PMID: 25495847
Diabetes mellitus; Online systems; Patient self-management; Self-efficacy; Repeated measures modelling; Qualitative methods
5.  Efficacy and safety of cognitive enhancers for patients with mild cognitive impairment: a systematic review and meta-analysis  
Cognitive enhancers, including cholinesterase inhibitors and memantine, are used to treat dementia, but their effectiveness for mild cognitive impairment is unclear. We conducted a systematic review to examine the efficacy and safety of cognitive enhancers for mild cognitive impairment.
Our eligibility criteria were studies of the effects of donepezil, rivastigmine, galantamine or memantine on mild cognitive impairment reporting cognition, function, behaviour, global status, and mortality or harms. We identified relevant material by searching electronic databases (e.g., MEDLINE, Embase), the references of included studies, trial registries and conference proceedings, and by contacting experts. Two reviewers independently screened the results of the literature search, abstracted data and appraised risk of bias using the Cochrane risk-of-bias tool.
We screened 15 554 titles and abstracts and 1384 full-text articles. Eight randomized clinical trials and 3 companion reports met our inclusion criteria. We found no significant effects of cognitive enhancers on cognition (Mini–Mental State Examination: 3 randomized clinical trials [RCTs], mean difference [MD] 0.14, 95% confidence interval [CI] −0.22 to 0.50; Alzheimer’s Disease Assessment Scale — cognition subscale: 3 RCTs, standardized MD −0.07, 95% CI−0.16 to 0.01]) or function (Alzheimer’s Disease Cooperative Study activities of daily living inventory: 2 RCTs, MD 0.30, 95% CI −0.26 to 0.86). Cognitive enhancers were associated with higher risks of nausea, diarrhea and vomiting than placebo.
Cognitive enhancers did not improve cognition or function among patients with mild cognitive impairment and were associated with a greater risk of gastrointestinal harms. Our findings do not support the use of cognitive enhancers for mild cognitive impairment.
doi: 10.1503/cmaj.130451
PMCID: PMC3826344  PMID: 24043661
6.  Mapping barriers and intervention activities to behaviour change theory for Mobilization of Vulnerable Elders in Ontario (MOVE ON), a multi-site implementation intervention in acute care hospitals 
As evidence-informed implementation interventions spread, they need to be tailored to address the unique needs of each setting, and this process should be well documented to facilitate replication. To facilitate the spread of the Mobilization of Vulnerable Elders in Ontario (MOVE ON) intervention, the aim of the current study is to develop a mapping guide that links identified barriers and intervention activities to behaviour change theory.
Focus groups were conducted with front line health-care professionals to identify perceived barriers to implementation of an early mobilization intervention targeted to hospitalized older adults. Participating units then used or adapted intervention activities from an existing menu or developed new activities to facilitate early mobilization. A thematic analysis was performed on the focus group data, emphasizing concepts related to barriers to behaviour change. A behaviour change theory, the ‘capability, opportunity, motivation-behaviour (COM-B) system’, was used as a taxonomy to map the identified barriers to their root causes. We also mapped the behaviour constructs and intervention activities to overcome these.
A total of 46 focus groups were conducted across 26 hospital inpatient units in Ontario, Canada, with 261 participants. The barriers were conceptualized at three levels: health-care provider (HCP), patient, and unit. Commonly mentioned barriers were time constraints and workload (HCP), patient clinical acuity and their perceived ‘sick role’ (patient), and lack of proper equipment and human resources (unit level). Thirty intervention activities to facilitate early mobilization of older adults were implemented across hospitals; examples of unit-developed intervention activities include the ‘mobility clock’ communication tool and the use of staff champions. A mapping guide was created with barriers and intervention activities matched though the lens of the COM-B system.
We used a systematic approach to develop a guide, which maps barriers, intervention activities, and behaviour change constructs in order to tailor an implementation intervention to the local context. This approach allows implementers to identify potential strategies to overcome local-level barriers and to document adaptations.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0160-6) contains supplementary material, which is available to authorized users.
PMCID: PMC4225038
Mobilization; Frail; Older adult; Hospital; Adaptations; Barriers; Tailored interventions
7.  Effectiveness of quality improvement strategies for coordination of care to reduce use of health care services: a systematic review and meta-analysis 
Frequent users of health care services are a relatively small group of patients who account for a disproportionately large amount of health care utilization. We conducted a meta-analysis of the effectiveness of interventions to improve the coordination of care to reduce health care utilization in this patient group.
We searched MEDLINE, Embase and the Cochrane Library from inception until May 2014 for randomized clinical trials (RCTs) assessing quality improvement strategies for the coordination of care of frequent users of the health care system. Articles were screened, and data abstracted and appraised for quality by 2 reviewers, independently. Random effects meta-analyses were conducted.
We identified 36 RCTs and 14 companion reports (total 7494 patients). Significantly fewer patients in the intervention group than in the control group were admitted to hospital (relative risk [RR] 0.81, 95% confidence interval [CI] 0.72–0.91). In subgroup analyses, a similar effect was observed among patients with chronic medical conditions other than mental illness, but not among patients with mental illness. In addition, significantly fewer patients 65 years and older in the intervention group than in the control group visited emergency departments (RR 0.69, 95% CI 0.54–0.89).
We found that quality improvement strategies for coordination of care reduced hospital admissions among patients with chronic conditions other than mental illness and reduced emergency department visits among older patients. Our results may help clinicians and policy-makers reduce utilization through the use of strategies that target the system (team changes, case management) and the patient (promotion of self-management).
PMCID: PMC4203622  PMID: 25225226
8.  Views of people with traumatic spinal cord injury about the components of self-management programs and program delivery: a Canadian pilot study 
BMC Neurology  2014;14(1):209.
Given the increasing emphasis on the community management of spinal cord injury (SCI), strategies that could be developed and implemented in order to empower and engage individuals with SCI in promoting their health and minimizing the risk of health conditions are required. A self-management program could be one approach to address these complex needs, including secondary complications. Thus, the objective of this study was to determine the importance attributed to the components of a self-management program by individuals with traumatic SCI and explore their views/opinions about the delivery of such a program.
Individuals with SCI were recruited by email via the Rick Hansen Institute (Vancouver, British Columbia, Canada) as well as an outpatient hospital spinal clinic. Data were collected by self-report using an on-line survey.
The final sample size was 99 individuals with traumatic SCI. The components of a self-management program that were rated as “very important” by the greatest proportion of participants included: exercise (n= 53; 53.5%), nutrition (n= 51; 51.5%), pain management (n= 44; 44.4%), information/education on aging with a SCI (n= 42; 42.4%), communicating with health care professionals (n= 40; 40.4%), problem solving (n= 40; 40.4%), transitioning from rehabilitation to the community (n= 40; 40.4%), and confidence (n= 40; 40.4%). Overall, 74.7% (n= 74) of the sample rated the overall importance of the development of a self-management program for individuals with traumatic SCI as “very important” or “important”. Almost 40% (n= 39) of the sample indicated that an internet-based self-management program would be the best delivery format. The highest proportion of participants indicated that the program should have individuals of a similar level of injury (n= 74; 74.7%); having individuals of a similar age (n= 40; 40.4%) was also noted. Over one-quarter of the sample (n= 24) had a depression score consistent with significant symptoms of depression.
Future research is needed to further evaluate how the views of people with traumatic SCI change over time. Our findings could be used to develop and pilot test a self-management program for individuals with traumatic SCI.
Electronic supplementary material
The online version of this article (doi:10.1186/s12883-014-0209-9) contains supplementary material, which is available to authorized users.
PMCID: PMC4210500  PMID: 25327610
Self-management; Exercise; Nutrition; Depression; Traumatic; Spinal cord injury; Survey
9.  Multiple Interacting Factors Influence Adherence, and Outcomes Associated with Surgical Safety Checklists: A Qualitative Study 
PLoS ONE  2014;9(9):e108585.
The surgical safety checklist (SSC) is meant to enhance patient safety but studies of its impact conflict. This study explored factors that influenced SSC adherence to suggest how its impact could be optimized.
Participants were recruited purposively by profession, region, hospital type and time using the SSC. They were asked to describe how the SSC was adopted, associated challenges, perceived impact, and suggestions for improving its use. Grounded theory and thematic analysis were used to collect and analyse data. Findings were interpreted using an implementation fidelity conceptual framework.
Fifty-one participants were interviewed (29 nurses, 13 surgeons, 9 anaesthetists; 18 small, 14 large and 19 teaching hospitals; 8 regions; 31 had used the SC for ≤12 months, 20 for 13+ months). The SSC was inconsistently reviewed, and often inaccurately documented as complete. Adherence was influenced by multiple issues. Extensive modification to accommodate existing practice patterns eliminated essential interaction at key time points to discuss patient management. Staff were often absent or not paying attention. They did not feel it was relevant to their work given limited evidence of its effectiveness, and because they were not engaged in its implementation. Organizations provided little support for implementation, training, monitoring and feedback, which are needed to overcome these, and other individual and team factors that challenged SSC adherence. Responses were similar across participants with different characteristics.
Multiple processes and factors influenced SSC adherence. This may explain why, in studies evaluating SSC impact, outcomes were variable. Recommendations included continuing education, time for pilot-testing, and engaging all staff in SSC review. Others may use the implementation fidelity framework to plan SSC implementation or evaluate SSC adherence. Further research is needed to establish which SSC components can be modified without compromising its effectiveness.
PMCID: PMC4178177  PMID: 25260030
10.  A knowledge translation tool improved osteoporosis disease management in primary care: an interrupted time series analysis 
Osteoporosis affects over 200 million people worldwide at a high cost to healthcare systems, yet gaps in management still exist. In response, we developed a multi-component osteoporosis knowledge translation (Op-KT) tool involving a patient-initiated risk assessment questionnaire (RAQ), which generates individualized best practice recommendations for physicians and customized education for patients at the point of care. The objective of this study was to evaluate the effectiveness of the Op-KT tool for appropriate disease management by physicians.
The Op-KT tool was evaluated using an interrupted time series design. This involved multiple assessments of the outcomes 12 months before (baseline) and 12 months after tool implementation (52 data points in total). Inclusion criteria were family physicians and their patients at risk for osteoporosis (women aged ≥50 years, men aged ≥65 years). Primary outcomes were the initiation of appropriate osteoporosis screening and treatment. Analyses included segmented linear regression modeling and analysis of variance.
The Op-KT tool was implemented in three family practices in Ontario, Canada representing 5 family physicians with 2840 age eligible patients (mean age 67 years; 76% women). Time series regression models showed an overall increase from baseline in the initiation of screening (3.4%; P < 0.001), any osteoporosis medications (0.5%; P = 0.006), and calcium or vitamin D (1.2%; P = 0.001). Improvements were also observed at site level for all the three sites considered, but these results varied across the sites. Of 351 patients who completed the RAQ unprompted (mean age 64 years, 77% women), the mean time for completing the RAQ was 3.43 minutes, and 56% had any disease management addressed by their physician. Study limitations included the inherent susceptibility of our design compared with a randomized trial.
The multicomponent Op-KT tool significantly increased osteoporosis investigations in three family practices, and highlights its potential to facilitate patient self-management. Next steps include wider implementation and evaluation of the tool in primary care.
Electronic supplementary material
The online version of this article (doi:10.1186/s13012-014-0109-9) contains supplementary material, which is available to authorized users.
PMCID: PMC4182792  PMID: 25252858
Knowledge translation; Clinical decision support; Chronic disease management; Primary care; Risk assessment; Osteoporosis; Interrupted time series analysis
11.  Sustainability of knowledge translation interventions in healthcare decision-making: protocol for a scoping review 
BMJ Open  2013;3(5):e002970.
Knowledge translation (KT also known as research utilisation, translational medicine and implementation science) is a dynamic and iterative process that includes the synthesis, dissemination, exchange and ethically sound application of knowledge to improve health. After the implementation of KT interventions, their impact on relevant outcomes should be monitored. The objectives of this scoping review are to: (1) conduct a systematic search of the literature to identify the impact on healthcare outcomes beyond 1 year, or beyond the termination of funding of the initiative of KT interventions targeting chronic disease management for end-users including patients, clinicians, public health officials, health services managers and policy-makers; (2) identify factors that influence sustainability of effective KT interventions; (3) identify how sustained change from KT interventions should be measured; and (4) develop a framework for assessing sustainability of KT interventions.
Methods and analysis
Comprehensive searches of relevant electronic databases (eg, MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials), websites of funding agencies and websites of healthcare provider organisations will be conducted to identify relevant material. We will include experimental, quasi-experimental and observational studies providing information on the sustainability of KT interventions targeting chronic disease management in adults and focusing on end-users including patients, clinicians, public health officials, health services managers and policy-makers. Two reviewers will pilot-test the screening criteria and data abstraction form. They will then screen all citations, full articles and abstract data in duplicate independently. The results of the scoping review will be synthesised descriptively and used to develop a framework to assess the sustainability of KT interventions.
Discussion and dissemination
Our results will help inform end-users (ie, patients, clinicians, public health officials, health services managers and policy-makers) regarding the sustainability of KT interventions. Our dissemination plan includes publications, presentations, website posting and a stakeholder meeting.
PMCID: PMC3657660  PMID: 23674448
knowledge translation; sustainability; implementation; research utilization; fidelity
12.  Seeing the forests and the trees—innovative approaches to exploring heterogeneity in systematic reviews of complex interventions to enhance health system decision-making: a protocol 
Systematic Reviews  2014;3:88.
To improve quality of care and patient outcomes, health system decision-makers need to identify and implement effective interventions. An increasing number of systematic reviews document the effects of quality improvement programs to assist decision-makers in developing new initiatives. However, limitations in the reporting of primary studies and current meta-analysis methods (including approaches for exploring heterogeneity) reduce the utility of existing syntheses for health system decision-makers. This study will explore the role of innovative meta-analysis approaches and the added value of enriched and updated data for increasing the utility of systematic reviews of complex interventions.
We will use the dataset from our recent systematic review of 142 randomized trials of diabetes quality improvement programs to evaluate novel approaches for exploring heterogeneity. These will include exploratory methods, such as multivariate meta-regression analyses and all-subsets combinatorial meta-analysis. We will then update our systematic review to include new trials and enrich the dataset by surveying authors of all included trials. In doing so, we will explore the impact of variables not, reported in previous publications, such as details of study context, on the effectiveness of the intervention. We will use innovative analytical methods on the enriched and updated dataset to identify key success factors in the implementation of quality improvement interventions for diabetes. Decision-makers will be involved throughout to help identify and prioritize variables to be explored and to aid in the interpretation and dissemination of results.
This study will inform future systematic reviews of complex interventions and describe the value of enriching and updating data for exploring heterogeneity in meta-analysis. It will also result in an updated comprehensive systematic review of diabetes quality improvement interventions that will be useful to health system decision-makers in developing interventions to improve outcomes for people with diabetes.
Systematic review registration
PROSPERO registration no. CRD42013005165
PMCID: PMC4174390  PMID: 25115289
Diabetes care; Knowledge translation; Quality improvement interventions; Complex Interventions; Health system decision-makers; Systematic review; Meta-analysis; Implementation science; Heterogeneity; Hierarchical modeling
13.  User-centered design of a web-based self-management site for individuals with type 2 diabetes – providing a sense of control and community 
To design and test a web-based self-management tool for patients with type 2 diabetes for its usability and feasibility.
An evidence-based, theory-driven website was created for patients with type 2 diabetes. Twenty-three patients with type 2 diabetes aged ≥ 25 years were recruited from 2 diabetes care centers in Toronto, Canada. We employed focus group methodology to assess acceptability, sustainability, strengths and weaknesses of the self-management website. Based on these results, revisions were made to the website. Three cycles of individual usability testing sessions using cognitive task analysis were conducted with patients with type 2 diabetes. Revisions to the website were made based on results from this testing.
We identified five themes concerning participants’ experiences of health care and related unmet needs: 1) Desire for information and for greater access to timely and personalized care to gain a sense of control of their disease; 2) Desire for community (sharing experiences with others) to fulfill practical and emotional needs; 3) Potential roles of an online self-management website in self-empowerment, behavior change, self-management and health care delivery; 4) Importance of a patient-centered perspective in presenting content (e.g. common assumptions, medical nomenclature, language, messaging, sociocultural context); 5) Barriers and facilitators to use of a self-management website (including perceived relevance of content, incorporation into usual routine, availability for goal-directed use, usability issues).
Participants outlined a series of unmet health care needs, and stated that they wanted timely access to tailored knowledge about their condition, mechanisms to control and track their disease, and opportunities to share experiences with other patients. These findings have implications for patients with type 2 diabetes of diverse ages, socioeconomic backgrounds, and disease severity, as well as to the design of other computer-based resources for chronic disease management.
PMCID: PMC4222757  PMID: 25056379
Diabetes mellitus; Self-efficacy; Intervention development; User-Computer Interface; Qualitative methods
14.  Histamine H2 receptor antagonists for decreasing gastrointestinal harms in adults using acetylsalicylic acid: systematic review and meta-analysis 
Open Medicine  2012;6(3):e109-e117.
It is unclear if histamine H2 receptor antagonists (H2 blockers) prevent a variety of gastrointestinal harms among patients taking acetylsalicylic acid (ASA) over long periods.
Electronic databases (e.g., MEDLINE, Embase and Cochrane Central Register of Controlled Trials; from inception to November 2010) and reference lists of retrieved articles were searched. Randomized placebo-controlled trials (RCTs) assessing the efficacy of H2 blockers in reducing gastrointestinal harms (bleeding, ulcers) among adults taking ASA for 2 weeks or longer were included. Two reviewers independently abstracted study and patient characteristics and appraised study quality using the Cochrane risk-of-bias tool. Peto odds ratio (OR) meta-analysis was performed, 95% confidence intervals (CIs) were calculated, and statistical heterogeneity was assessed using the I2 and χ2 statistics.
Six RCTs (4 major publications and 2 companion reports) with a total of 498 participants (healthy volunteers or patients with arthritis, cardiovascular or cerebrovascular disease, or diabetes mellitus) were included. One trial adequately reported allocation concealment and sequence generation, with the other 3 trials being judged as unclear for both aspects. In one RCT, no statistically significant differences for gastrointestinal hemorrhage requiring admission to hospital (p = 0.14) or blood transfusion (p = 0.29) were observed between the group receiving concomitant famotidine and ASA and the group receiving concomitant placebo and ASA. After a median of 8 weeks’ follow-up, H2 blockers were more effective than placebo in reducing gastrointestinal hemorrhage (2 RCTs, total of 447 patients, OR 0.07, 95% CI 0.02–0.23) and peptic ulcers (3 RCTs, total of 465 patients, OR 0.21, 95% CI 0.12–0.36) among patients taking ASA for 2 weeks or longer. Despite substantial clinical heterogeneity across the studies, including types of H2 blockers, dosing of ASA and underlying conditions, no statistical heterogeneity was observed.
H2 blockers reduced gastrointestinal harm among patients taking ASA for 2 weeks or longer. These results should be interpreted with caution, because of the small number of studies identified for inclusion.
PMCID: PMC3654505  PMID: 23687524
15.  Efficacy of turmeric in the treatment of digestive disorders: a systematic review and meta-analysis protocol 
Systematic Reviews  2014;3:71.
Digestive disorders pose significant burdens to millions of people worldwide in terms of morbidity, mortality and healthcare costs. Turmeric has been traditionally used for conditions associated with the digestive system, and its therapeutic benefits were also confirmed in clinical studies. However, rigorous systematic review on this topic is severely limited. Our study aims to systematically review the therapeutic and adverse effects of turmeric and its compounds on digestive disorders, including dyspepsia, peptic ulcer, irritable bowel disease, Crohn’s disease, ulcerative colitis, and gastroesophageal reflux disease.
This study will include both randomized controlled trials and non-randomized controlled trials assessing the efficacy and safety of turmeric or its compounds in comparison to a placebo or any other active interventions for digestive disorders without any restrictions on participant age or language of publication. The primary outcome is the proportion of patients that have experienced treatment success. Secondary outcomes are the prevalence of an individual symptom of digestive disorders, the proportion of patients who experienced relapse, the number of physician visits/hospitalization due to digestive disorders, health-related quality of life and the proportion of patients who experienced adverse events. Relevant studies will be identified through MEDLINE, EMBASE, AMED, Dissertations & Theses Database and the Cochrane Central Register of Control Trials from their inception to August 31, 2013. In addition, grey literature such as information published on drug regulatory agencies websites and abstracts/proceedings from conferences will also be reviewed. A calibration exercise will be conducted in a process of study screening, whereby two reviewers will independently screen titles and abstracts from the literature search. Any conflicts will be resolved through a subsequent team discussion. The same process will be adopted in data abstraction and methodological quality appraisal by the Cochrane Risk of Bias Tool and the Newcastle-Ottawa Scale. We will describe study and patient characteristics, risk of bias/methodological quality results, and outcomes of the included studies. If we have sufficient data and homogeneity, a random effects meta-analysis will be performed.
Our results will help patients and healthcare practitioners to make informed decisions when considering turmeric as an alternative therapy for digestive disorders.
Trial registration
PROSPERO registry number: CRD42013005739.
PMCID: PMC4080703  PMID: 24973984
16.  Comparative safety of anti-epileptic drugs among infants and children exposed in utero or during breastfeeding: protocol for a systematic review and network meta-analysis 
Systematic Reviews  2014;3:68.
Epilepsy affects about 1% of the general population. Anti-epileptic drugs (AEDs) prevent or terminate seizures in individuals with epilepsy. Pregnant women with epilepsy may continue taking AEDs. Many of these agents cross the placenta and increase the risk of major congenital malformations, early cognitive and developmental delays, and infant mortality. We aim to evaluate the comparative safety of AEDs approved for chronic use in Canada when administered to pregnant and breastfeeding women and the effects on their infants and children through a systematic review and network meta-analysis.
Studies examining the effects of AEDs administered to pregnant and breastfeeding women regardless of indication (e.g., epilepsy, migraine, pain, psychiatric disorders) on their infants and children will be included. We will include randomized clinical trials (RCTs), quasi-RCTs, non-RCTs, controlled before-after, interrupted time series, cohort, registry, and case-control studies. The main literature search will be executed in MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials. We will seek unpublished literature through searches of trial protocol registries and conference abstracts. The literature search results screening, data abstraction, and risk of bias appraisal will be performed by two individuals, independently. Conflicts will be resolved through discussion. The risk of bias of experimental and quasi-experimental studies will be appraised using the Cochrane Effective Practice and Organization of Care Risk-of-Bias tool, methodological quality of observational studies will be appraised using the Newcastle-Ottawa Scale, and quality of reporting of safety outcomes will be conducted using the McMaster Quality Assessment Scale of Harms (McHarm) tool. If feasible and appropriate, we will conduct random effects meta-analysis. Network meta-analysis will be considered for outcomes that fulfill network meta-analysis assumptions.
The primary outcome is major congenital malformations (overall and by specific types), while secondary outcomes include fetal loss/miscarriage, minor congenital malformations (overall and by specific types), cognitive development, psychomotor development, small for gestational age, preterm delivery, and neonatal seizures.
Our systematic review will address safety concerns regarding the use of AEDs during pregnancy and breastfeeding. Our results will be useful to healthcare providers, policy-makers, and women of childbearing age who are taking anti-epileptic medications.
Systematic review registration
PROSPERO CRD42014008925.
PMCID: PMC4086277  PMID: 24964932
Anti-epileptic drug; Breastfeeding; Comparative safety; Congenital malformation; Epilepsy; Fetus; Infant; Network meta-analysis; Pregnancy; Systematic review
17.  Hospital at home: home-based end of life care 
The policy in a number of countries is to provide people with a terminal illness the choice of dying at home. This policy is supported by surveys indicating that the general public and patients with a terminal illness would prefer to receive end of life care at home.
To determine if providing home-based end of life care reduces the likelihood of dying in hospital and what effect this has on patients’ symptoms, quality of life, health service costs and care givers compared with inpatient hospital or hospice care.
Search methods
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library) to October 2009, Ovid MED-LINE(R) 1950 to March 2011, EMBASE 1980 to October 2009, CINAHL 1982 to October 2009 and EconLit to October 2009. We checked the reference lists of articles identified for potentially relevant articles.
Selection criteria
Randomised controlled trials, interrupted time series or controlled before and after studies evaluating the effectiveness of home-based end of life care with inpatient hospital or hospice care for people aged 18 years and older.
Data collection and analysis
Two authors independently extracted data and assessed study quality. We combined the published data for dichotomous outcomes using fixed-effect Mantel-Haenszel meta-analysis. When combining outcome data was not possible we presented the data in narrative summary tables.
Main results
We included four trials in this review. Those receiving home-based end of life care were statistically significantly more likely to die at home compared with those receiving usual care (RR 1.33, 95% CI 1.14 to 1.55, P = 0.0002; Chi 2 = 1.72, df = 2, P = 0.42, I2 = 0% (three trials; N=652)). We detected no statistically significant differences for functional status (measured by the Barthel Index), psychological well-being or cognitive status, between patients receiving home-based end of life care compared with those receiving standard care (which included inpatient care). Admission to hospital while receiving home-based end of life care varied between trials and this was reflected by high levels of statistically significant heterogeneity in this analysis. There was some evidence of increased patient satisfaction with home-based end of life care, and little evidence of the impact this form of care has on care givers.
Authors’ conclusions
The evidence included in this review supports the use of end of life home-care programmes for increasing the number of patients who will die at home, although the numbers of patients being admitted to hospital while receiving end of life care should be monitored. Future research should also systematically assess the impact of end of life home care on care givers.
PMCID: PMC4033790  PMID: 21735440
*Attitude to Death; *Home Care Services; Hospice Care [*psychology]; Patient Preference [*psychology]; Randomized Controlled Trials as Topic; Adult; Humans
18.  Safety and effectiveness of antiretroviral therapies for HIV-infected women and their infants and children: protocol for a systematic review and network meta-analysis 
Systematic Reviews  2014;3:51.
Antiretroviral therapy reduces mother-to-child transmission of human immunodeficiency virus (HIV) during pregnancy, delivery, and breastfeeding. However, these agents have been associated with preterm birth, anemia and low birth weight. We aim to evaluate the comparative safety and effectiveness of the use of antiretroviral drugs among HIV-infected women and the effects on their infants and children through a systematic review and network meta-analysis.
Studies examining the effects of six antiretroviral drug classes (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, protease inhibitors, integrase inhibitors, fusion inhibitors, co-receptor inhibitors) administered to HIV-infected pregnant women will be included. We will include randomized clinical trials (RCTs), quasi-RCTs, non-RCTs, controlled before-after, interrupted time series, cohort, registry, and case–control studies. No limitations will be imposed on publication status (that is, unpublished studies are eligible for inclusion), duration of follow-up, study conduct period, and language of dissemination. Comprehensive literature searches will be conducted in major electronic databases, including MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trials. Gray literature will be identified through searching dissertation databases, trial protocol registries, and conference abstracts.
Two team members will independently screen all citations, full-text articles, and abstract data; conflicts will be resolved through discussion. The risk of bias and methodological quality will be appraised using appropriate tools (for example, Cochrane Collaboration’s tool for assessing risk of bias, Newcastle-Ottawa Scale, and McMaster Quality Assessment Scale of Harms). If feasible and appropriate, we will conduct random effects meta-analysis. Network meta-analysis will be considered for outcomes with the greatest number of treatment comparisons available that fulfill network meta-analysis assumptions (for example, consistency of evidence between direct and indirect data, and low statistical heterogeneity between included studies).
The primary effectiveness outcome is mother-to-child transmission of HIV, and the primary safety outcome is major congenital malformation (overall and specific types) among newborns of HIV-infected women. Secondary safety outcomes include stillbirths, infant/child death, preterm delivery, overall and specific minor congenital malformations, and small for gestational age infants.
Our systematic review will be of utility to healthcare providers, policy-makers, and HIV-positive women regarding the use of antiretroviral drugs.
Trial registration
PROSPERO registry number: CRD42014009071.
PMCID: PMC4039063  PMID: 24887455
antiretroviral therapy; breastfeeding; congenital malformation; human immunodeficiency virus; fetus; mother-to-child-transmission; pregnancy
19.  WikiBuild: A New Online Collaboration Process For Multistakeholder Tool Development and Consensus Building 
Production of media such as patient education tools requires methods that can integrate multiple stakeholder perspectives. Existing consensus techniques are poorly suited to design of visual media, can be expensive and logistically demanding, and are subject to caveats arising from group dynamics such as participant hierarchies.
Our objective was to develop a method that enables multistakeholder tool building while averting these difficulties.
We developed a wiki-inspired method and tested this through the collaborative design of an asthma action plan (AAP). In the development stage, we developed the Web-based tool by (1) establishing AAP content and format options, (2) building a Web-based application capable of representing each content and format permutation, (3) testing this tool among stakeholders, and (4) revising this tool based on stakeholder feedback. In the wiki stage, groups of participants used the revised tool in three separate 1-week “wiki” periods during which each group collaboratively authored an AAP by making multiple online selections.
In the development stage, we recruited 16 participants (9/16 male) (4 pulmonologists, 4 primary care physicians, 3 certified asthma educators, and 5 patients) for system testing. The mean System Usability Scale (SUS) score for the tool used in testing was 72.2 (SD 10.2). In the wiki stage, we recruited 41 participants (15/41 male) (9 pulmonologists, 6 primary care physicians, 5 certified asthma educators, and 21 patients) from diverse locations. The mean SUS score for the revised tool was 75.9 (SD 19.6). Users made 872, 466, and 599 successful changes to the AAP in weeks 1, 2, and 3, respectively. The site was used actively for a mean of 32.0 hours per week, of which 3.1 hours per week (9.7%) constituted synchronous multiuser use (2–4 users at the same time). Participants averaged 23 (SD 33) minutes of login time and made 7.7 (SD 15) changes to the AAP per day. Among participants, 28/35 (80%) were satisfied with the final AAP, and only 3/34 (9%) perceived interstakeholder group hierarchies.
Use of a wiki-inspired method allowed for effective collaborative design of content and format aspects of an AAP while minimizing logistical requirements, maximizing geographical representation, and mitigating hierarchical group dynamics. Our method faced unique software and hardware challenges, and raises certain questions regarding its effect on group functioning. Potential uses of our method are broad, and further studies are required.
PMCID: PMC3278094  PMID: 22155694
Consensus; focus groups; user-computer interface; Web 2.0; asthma; self-care
21.  The development of an online decision support tool for organizational readiness for change 
Much importance has been placed on assessing readiness for change as one of the earliest steps of implementation, but measuring it can be a complex and daunting task. Organizations and individuals struggle with how to reliably and accurately measure readiness for change. Several measures have been developed to help organizations assess readiness, but these are often underused due to the difficulty of selecting the right measure. In response to this challenge, we will develop and test a prototype of a decision support tool that is designed to guide individuals interested in implementation in the selection of an appropriate readiness assessment measure for their setting.
A multi-phase approach will be used to develop the decision support tool. First, we will identify key measures for assessing organizational readiness for change from a recently completed systematic review. Included measures will be those developed for healthcare settings (e.g., acute care, public health, mental health) and that have been deemed valid and reliable. Second, study investigators and field experts will engage in a mapping exercise to categorize individual items of included measures according to key readiness constructs from an existing framework. Third, a stakeholder panel will be recruited and consulted to determine the feasibility and relevance of the selected measures using a modified Delphi process. Fourth, findings from the mapping exercise and stakeholder consultation will inform the development of a decision support tool that will guide users in appropriately selecting change readiness measures. Fifth, the tool will undergo usability testing.
Our proposed decision support tool will address current challenges in the field of organizational change readiness by aiding individuals in selecting a valid and reliable assessment measure that is relevant to user needs and practice settings. We anticipate that implementers and researchers who use our tool will be more likely to conduct readiness for change assessments in their settings when planning for implementation. This, in turn, may contribute to more successful implementation outcomes. We will test this tool in a future study to determine its efficacy and impact on implementation processes.
PMCID: PMC4030031  PMID: 24886072
Readiness for change; Readiness assessment; Decision support tool; Implementation; Implementation support; Implementation planning
22.  Perceived facilitators and barriers to self-management in individuals with traumatic spinal cord injury: a qualitative descriptive study 
BMC Neurology  2014;14:48.
Current evidence has suggested the need for increased self-management support efforts in spinal cord injury (SCI) to reduce secondary complications. However, current self-management programs may not be suitable for the unique needs of individuals with SCI, including reduced mobility and the importance of attendant care. There is a need for greater understanding of the self-management strategies adopted by individuals with SCI and the potential need for a tailored self-management program. Thus, the purpose of the current study was to understand the perceived facilitators and barriers to self-management to prevent secondary complications.
A descriptive qualitative approach was used and involved telephone interviews. Semi-structured interviews were conducted with individuals with traumatic SCI, their family members/caregivers, and managers from acute care/trauma and rehabilitation centres. Participants were recruited between September 2011 and May 2012. Analysis was conducted using inductive thematic analysis to understand the perceived facilitators and barriers to self-management to prevent secondary complications.
A total of 26 interviews were conducted and they included 7 individuals with traumatic SCI, 7 family/caregivers (i.e., 7 SCI-caregiver dyads), and 12 acute care/rehabilitation managers from across the province of Ontario. The following five facilitators to self-management were identified: physical support from the caregiver, emotional support from the caregiver, peer support and feedback, importance of positive outlook and acceptance, and maintaining independence/control over care. The following five barriers to self-management were identified: caregiver burnout, funding and funding policies, lack of accessibility, physical limitations and secondary complications, and difficulties achieving positive outlook or mood.
This study demonstrated that the caregiver and the individual’s own mood/outlook, among other facilitators and barriers, make significant contributions to the self-management of individuals with traumatic SCI. The issues of timing/readiness and comorbidities and aging were observed across many of these themes. As such, the development of a tailored self-management program for individuals with traumatic SCI and their caregivers should incorporate these considerations.
PMCID: PMC4007626  PMID: 24624961
Facilitators; Barriers; Self-management; Traumatic; Spinal cord injury; Qualitative
23.  Chronic disease and falls in community-dwelling Canadians over 65 years old: a population-based study exploring associations with number and pattern of chronic conditions 
BMC Geriatrics  2014;14:22.
Falls and chronic disease are both important health issues in older adults. The objectives of this study were to quantify the prevalence of falls and multi-morbidity (≥2 chronic conditions) in Canadian older adults; examine associations between falls and number of chronic conditions; and explore whether certain patterns of chronic disease were associated with a greater risk of falling.
Data were derived from the Canadian Community Health Survey- Healthy Aging. Primary outcomes from 16,357 community-dwelling adults aged 65 years and over were self-reported falls in the previous 12 months and presence of 13 chronic conditions. Prevalence estimates were calculated with normalized sampling weights, and hierarchical cluster analysis was used to identify clusters based on chronic condition patterns, and tested for association to falls with logistic regression.
Overall prevalence of falling and multi-morbidity were 19.8% and 62.0% respectively. Fall risk was significantly greater in individuals with one, two, four, five and six or more chronic conditions relative to those with none (all p < 0.05). A seven-cluster model was selected, including groups with low prevalence of chronic disease, or high prevalence of hypertension and arthritis, visual impairment, hypertension, chronic obstructive pulmonary disease (COPD), diabetes, or heart disease and hypertension. Only the hypertension cluster (Odds Ratio [OR] = 1.2) and COPD cluster (OR = 1.6) were significantly associated with increased falls relative to the low prevalence group.
Both the number and pattern of chronic conditions were related to falls. COPD emerged as a significant predictor of falls despite affecting a smaller proportion of respondents. Continued study is warranted to verify this association and determine how to incorporate consideration of chronic disease and multi-morbidity into fall risk assessments.
PMCID: PMC3928582  PMID: 24529293
24.  Effect of an Educational Toolkit on Quality of Care: A Pragmatic Cluster Randomized Trial 
PLoS Medicine  2014;11(2):e1001588.
In a pragmatic cluster-randomized trial, Baiju Shah and colleagues evaluated the effectiveness of printed educational materials for clinician education focusing on cardiovascular disease screening and risk reduction in people with diabetes.
Please see later in the article for the Editors' Summary
Printed educational materials for clinician education are one of the most commonly used approaches for quality improvement. The objective of this pragmatic cluster randomized trial was to evaluate the effectiveness of an educational toolkit focusing on cardiovascular disease screening and risk reduction in people with diabetes.
Methods and Findings
All 933,789 people aged ≥40 years with diagnosed diabetes in Ontario, Canada were studied using population-level administrative databases, with additional clinical outcome data collected from a random sample of 1,592 high risk patients. Family practices were randomly assigned to receive the educational toolkit in June 2009 (intervention group) or May 2010 (control group). The primary outcome in the administrative data study, death or non-fatal myocardial infarction, occurred in 11,736 (2.5%) patients in the intervention group and 11,536 (2.5%) in the control group (p = 0.77). The primary outcome in the clinical data study, use of a statin, occurred in 700 (88.1%) patients in the intervention group and 725 (90.1%) in the control group (p = 0.26). Pre-specified secondary outcomes, including other clinical events, processes of care, and measures of risk factor control, were also not improved by the intervention. A limitation is the high baseline rate of statin prescribing in this population.
The educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Despite being relatively easy and inexpensive to implement, printed educational materials were not effective. The study highlights the need for a rigorous and scientifically based approach to the development, dissemination, and evaluation of quality improvement interventions.
Trial Registration NCT01411865 and NCT01026688
Please see later in the article for the Editors' Summary
Editors' Summary
Clinical practice guidelines help health care providers deliver the best care to patients by combining all the evidence on disease management into specific recommendations for care. However, the implementation of evidence-based guidelines is often far from perfect. Take the example of diabetes. This common chronic disease, which is characterized by high levels of sugar (glucose) in the blood, impairs the quality of life of patients and shortens life expectancy by increasing the risk of cardiovascular diseases (conditions that affect the heart and circulation) and other life-threatening conditions. Patients need complex care to manage the multiple risk factors (high blood sugar, high blood pressure, high levels of fat in the blood) that are associated with the long-term complications of diabetes, and they need to be regularly screened and treated for these complications. Clinical practice guidelines for diabetes provide recommendations on screening and diagnosis, drug treatment, and cardiovascular disease risk reduction, and on helping patients self-manage their disease. Unfortunately, the care delivered to patients with diabetes frequently fails to meet the standards laid down in these guidelines.
Why Was This Study Done?
How can guideline adherence and the quality of care provided to patients be improved? A common approach is to send printed educational materials to clinicians. For example, when the Canadian Diabetes Association (CDA) updated its clinical practice guidelines in 2008, it mailed educational toolkits that contained brochures and other printed materials targeting key themes from the guidelines to family physicians. In this pragmatic cluster randomized trial, the researchers investigate the effect of the CDA educational toolkit that targeted cardiovascular disease screening and treatment on the quality of care of people with diabetes. A pragmatic trial asks whether an intervention works under real-life conditions and whether it works in terms that matter to the patient; a cluster randomized trial randomly assigns groups of people to receive alternative interventions and compares outcomes in the differently treated “clusters.”
What Did the Researchers Do and Find?
The researchers randomly assigned family practices in Ontario, Canada to receive the educational toolkit in June 2009 (intervention group) or in May 2010 (control group). They examined outcomes between July 2009 and April 2010 in all patients with diabetes in Ontario aged over 40 years (933,789 people) using population-level administrative data. In Canada, administrative databases record the personal details of people registered with provincial health plans, information on hospital visits and prescriptions, and physician service claims for consultations, assessments, and diagnostic and therapeutic procedures. They also examined clinical outcome data from a random sample of 1,592 patients at high risk of cardiovascular complications. In the administrative data study, death or non-fatal heart attack (the primary outcome) occurred in about 11,500 patients in both the intervention and control group. In the clinical data study, the primary outcome―use of a statin to lower blood fat levels―occurred in about 700 patients in both study groups. Secondary outcomes, including other clinical events, processes of care, and measures of risk factor control were also not improved by the intervention. Indeed, in the administrative data study, some processes of care outcomes related to screening for heart disease were statistically significantly worse in the intervention group than in the control group, and in the clinical data study, fewer patients in the intervention group reached blood pressure targets than in the control group.
What Do These Findings Mean?
These findings suggest that the CDA cardiovascular diseases educational toolkit did not improve quality of care or cardiovascular outcomes in a population with diabetes. Indeed, the toolkit may have led to worsening in some secondary outcomes although, because numerous secondary outcomes were examined, this may be a chance finding. Limitations of the study include its length, which may have been too short to see an effect of the intervention on clinical outcomes, and the possibility of a ceiling effect—the control group in the clinical data study generally had good care, which left little room for improvement of the quality of care in the intervention group. Overall, however, these findings suggest that printed educational materials may not be an effective way to improve the quality of care for patients with diabetes and other complex conditions and highlight the need for a rigorous, scientific approach to the development, dissemination, and evaluation of quality improvement interventions.
Additional Information
Please access these websites via the online version of this summary at
The US National Diabetes Information Clearinghouse provides information about diabetes for patients, health care professionals, and the general public (in English and Spanish)
The UK National Health Service Choices website provides information (including some personal stories) for patients and carers about type 2 diabetes, the commonest form of diabetes
The Canadian Diabetes Association also provides information about diabetes for patients (including some personal stories about living with diabetes) and health care professionals; its latest clinical practice guidelines are available on its website
The UK National Institute for Health and Care Excellence provides general information about clinical guidelines and about health care quality standards in the UK
The US Agency for Healthcare Research and Quality aims to improve the quality, safety, efficiency, and effectiveness of health care for all Americans (information in English and Spanish); the US National Guideline Clearinghouse is a searchable database of clinical practice guidelines
The International Diabetes Federation provides information about diabetes for patients and health care professionals, along with international statistics on the burden of diabetes
PMCID: PMC3913553  PMID: 24505216
25.  Designing and evaluating an interprofessional shared decision-making and goal-setting decision aid for patients with diabetes in clinical care - systematic decision aid development and study protocol 
Care of patients with diabetes often occurs in the context of other chronic illness. Competing disease priorities and competing patient-physician priorities present challenges in the provision of care for the complex patient. Guideline implementation interventions to date do not acknowledge these intricacies of clinical practice. As a result, patients and providers are left overwhelmed and paralyzed by the sheer volume of recommendations and tasks. An individualized approach to the patient with diabetes and multiple comorbid conditions using shared decision-making (SDM) and goal setting has been advocated as a patient-centred approach that may facilitate prioritization of treatment options. Furthermore, incorporating interprofessional integration into practice may overcome barriers to implementation. However, these strategies have not been taken up extensively in clinical practice.
To systematically develop and test an interprofessional SDM and goal-setting toolkit for patients with diabetes and other chronic diseases, following the Knowledge to Action framework.
1. Feasibility study: Individual interviews with primary care physicians, nurses, dietitians, pharmacists, and patients with diabetes will be conducted, exploring their experiences with shared decision-making and priority-setting, including facilitators and barriers, the relevance of a decision aid and toolkit for priority-setting, and how best to integrate it into practice.
2. Toolkit development: Based on this data, an evidence-based multi-component SDM toolkit will be developed. The toolkit will be reviewed by content experts (primary care, endocrinology, geriatricians, nurses, dietitians, pharmacists, patients) for accuracy and comprehensiveness.
3. Heuristic evaluation: A human factors engineer will review the toolkit and identify, list and categorize usability issues by severity.
4. Usability testing: This will be done using cognitive task analysis.
5. Iterative refinement: Throughout the development process, the toolkit will be refined through several iterative cycles of feedback and redesign.
Interprofessional shared decision-making regarding priority-setting with the use of a decision aid toolkit may help prioritize care of individuals with multiple comorbid conditions. Adhering to principles of user-centered design, we will develop and refine a toolkit to assess the feasibility of this approach.
PMCID: PMC3937124  PMID: 24450385
Shared decision-making; Priority setting; Patient decision aid; Interprofessional care; Diabetes mellitus; Patient education; Medical informatics; Toolkit development; Study protocol; User-centred design; Qualitative methods

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