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1.  Patient engagement in research: a systematic review 
Background
A compelling ethical rationale supports patient engagement in healthcare research. It is also assumed that patient engagement will lead to research findings that are more pertinent to patients’ concerns and dilemmas. However; it is unclear how to best conduct this process. In this systematic review we aimed to answer 4 key questions: what are the best ways to identify patient representatives? How to engage them in designing and conducting research? What are the observed benefits of patient engagement? What are the harms and barriers of patient engagement?
Methods
We searched MEDLINE, EMBASE, PsycInfo, Cochrane, EBSCO, CINAHL, SCOPUS, Web of Science, Business Search Premier, Academic Search Premier and Google Scholar. Included studies were published in English, of any size or design that described engaging patients or their surrogates in research design. We conducted an environmental scan of the grey literature and consulted with experts and patients. Data were analyzed using a non-quantitative, meta-narrative approach.
Results
We included 142 studies that described a spectrum of engagement. In general, engagement was feasible in most settings and most commonly done in the beginning of research (agenda setting and protocol development) and less commonly during the execution and translation of research. We found no comparative analytic studies to recommend a particular method. Patient engagement increased study enrollment rates and aided researchers in securing funding, designing study protocols and choosing relevant outcomes. The most commonly cited challenges were related to logistics (extra time and funding needed for engagement) and to an overarching worry of a tokenistic engagement.
Conclusions
Patient engagement in healthcare research is likely feasible in many settings. However, this engagement comes at a cost and can become tokenistic. Research dedicated to identifying the best methods to achieve engagement is lacking and clearly needed.
doi:10.1186/1472-6963-14-89
PMCID: PMC3938901  PMID: 24568690
Systematic review; Patient; Engagement; Patient centered outcomes research
2.  A systematic review of patient-reported measures of burden of treatment in three chronic diseases 
Background
Burden of treatment refers to the workload of health care and its impact on patient functioning and well-being. There are a number of patient-reported measures that assess burden of treatment in single diseases or in specific treatment contexts. A review of such measures could help identify content for a general measure of treatment burden that could be used with patients dealing with multiple chronic conditions. We reviewed the content and psychometric properties of patient-reported measures that assess aspects of treatment burden in three chronic diseases, ie, diabetes, chronic kidney disease, and heart failure.
Methods
We searched Ovid MEDLINE, Ovid EMBASE, Ovid PsycINFO, and EBSCO CINAHL through November 2011. Abstracts were independently reviewed by two people, with disagreements adjudicated by a third person. Retrieved articles were reviewed to confirm relevance, with patient-reported measures scrutinized to determine consistency with the definition of burden of treatment. Descriptive information and psychometric properties were extracted.
Results
A total of 5686 abstracts were identified from the database searches. After abstract review, 359 full-text articles were retrieved, of which 76 met our inclusion criteria. An additional 22 articles were identified from the references of included articles. From the 98 studies, 57 patient-reported measures of treatment burden (full measures or components within measures) were identified. Most were multi-item scales (89%) and assessed treatment burden in diabetes (82%). Only 15 measures were developed using direct patient input and had demonstrable evidence of reliability, scale structure, and multiple forms of validity; six of these demonstrated evidence of sensitivity to change. We identified 12 content domains common across measures and disease types.
Conclusion
Available measures of treatment burden in single diseases can inform derivation of a patient-centered measure of the construct in patients with multiple chronic conditions. Patients should take part in developing the measure to ensure salience and relevance.
doi:10.2147/PROM.S44694
PMCID: PMC3699294  PMID: 23833553
patient-reported outcomes; treatment burden; questionnaire; psychometric properties; self-management; patient-centered
3.  Influenza vaccines licensed in the United States in healthy children: a systematic review and network meta-analysis (Protocol) 
Systematic Reviews  2012;1:65.
Background
Influenza is an acute respiratory illness caused by influenza viruses, which occurs in epidemics worldwide every year. Children are an important target for prevention methods, including vaccination. While evidence about the decision on whether to vaccinate healthy children is robust, evidence supporting the decision of which of available vaccines to use remains unclear.
This review will summarize the evidence about the efficacy and safety of the available vaccines for seasonal influenza licensed in the United States for use in healthy children.
Methods/design
An umbrella systematic review (SR) and network meta-analysis will be conducted of randomized controlled trials (RCTs). We will search for SRs to identify parallel RCTs evaluating inactive and/or live attenuated influenza vaccines licensed in the United States for use in healthy children to prevent influenza. Subsequently, we will update the literature search of the selected SRs to the present time to capture recent controlled studies. To complement the work focused on harms, we will also select observational studies focusing on post marketing retrospective studies. Inclusion will not be limited by language, publication date or publication status. To identify additional candidate studies, we will review the reference lists of the eligible primary studies and narrative reviews; we will query the expert members of the Advisory Committee on Immunization Practices and review references from their previous statement. Additionally, we will review the reports from the Institute of Medicine on the adverse effects of vaccines. Two reviewers will independently determine study eligibility and will extract descriptive, methodological (using the Cochrane risk of bias tool for RCTs and the Newcastle–Ottawa scale for observational studies) and efficacy data. When possible, we will conduct meta-analyses and network meta-analyses by combining indirect and direct comparisons.
We will evaluate heterogeneity using the I2 statistic and the agreement of indirect comparisons and direct evidence. We will report the Cochrane Q test to determine the statistical significance of heterogeneity.
The overall quality of evidence will be assessed following the GRADE (Grading of Recommendation, Assessment, Development and Evaluation) approach.
Discussion
Our systematic review will allow patients, clinicians, guideline developers and policy makers to make evidence-based choices between the two available vaccine options, by providing information regarding benefits and harms of these types of vaccines.
doi:10.1186/2046-4053-1-65
PMCID: PMC3537683  PMID: 23272706
Influenza; Influenza vaccine; Children; Systematic review
4.  Drugs commonly associated with weight change: umbrella systematic review and meta-analysis (Protocol) 
Systematic Reviews  2012;1:44.
Background
Many drugs and treatments given to patients for various reasons affect their weight. This side effect is of great importance to patients and is also a concern for the treating physician because weight change may lead to the emergence or worsening of other health conditions.
Objective
The aim of this study is to summarize the evidence about commonly prescribed drugs and their association with weight change.
Methods/Design
Umbrella systematic review and meta-analysis of randomized controlled trials.
We will use an umbrella approach to identify eligible randomized controlled trials (RCTs). We will search for systematic reviews of RCTs that compare any of the drugs that have been associated with weight gain (obesogenic) or weight loss (leptogenic); these have been summarized by our experts’ panel in a predefined list. Two reviewers will independently determine RCT eligibility. Disagreement will be solved by consensus and arbitrated by a third reviewer. We will extract descriptive, methodological, and efficacy data in duplicate. Our primary continuous outcomes will be weight loss or gain expressed as a mean difference (MD) for weight (kg) or BMI (kg/m2). We will calculate the MD considering the mean difference in weight or BMI between baseline and the last available follow-up in both study arms (drugs and placebo). Our primary dichotomous outcome, presented as a relative risk, will compare the ratio of the incidence of weight change in each trial arm. When possible, results will be pooled using classic random-effects meta-analyses and a summary estimate with 95% confidence interval will provided. We will use the I2 statistic and Cochran’s Q test to assess heterogeneity. The risk of bias will be assessed using the Cochrane risk of bias tool. Publication bias, if appropriate, will be evaluated, as well as overall strength of the evidence.
Discussion
This systematic review will offer the opportunity to generate a ranking of commonly prescribed drugs in terms of their effect on weight, allowing guideline developers and patient-physician dyad to choose between available therapies.
doi:10.1186/2046-4053-1-44
PMCID: PMC3582551  PMID: 23020969
Drug; Adults; Obesogenic; Leptogenic; Weight loss; Weight gain; Weight change; Systematic review
5.  Treatment of hyperprolactinemia: a systematic review and meta-analysis 
Systematic Reviews  2012;1:33.
Background
Hyperprolactinemia is a common endocrine disorder that can be associated with significant morbidity. We conducted a systematic review and meta-analyses of outcomes of hyperprolactinemic patients, including microadenomas and macroadenomas, to provide evidence-based recommendations for practitioners. Through this review, we aimed to compare efficacy and adverse effects of medications, surgery and radiotherapy in the treatment of hyperprolactinemia.
Methods
We searched electronic databases, reviewed bibliographies of included articles, and contacted experts in the field. Eligible studies provided longitudinal follow-up of patients with hyperprolactinemia and evaluated outcomes of interest. We collected descriptive, quality and outcome data (tumor growth, visual field defects, infertility, sexual dysfunction, amenorrhea/oligomenorrhea and prolactin levels).
Results
After review, 8 randomized and 178 nonrandomized studies (over 3,000 patients) met inclusion criteria. Compared to no treatment, dopamine agonists significantly reduced prolactin level (weighted mean difference, -45; 95% confidence interval, -77 to −11) and the likelihood of persistent hyperprolactinemia (relative risk, 0.90; 95% confidence interval, 0.81 to 0.99). Cabergoline was more effective than bromocriptine in reducing persistent hyperprolactinemia, amenorrhea/oligomenorrhea, and galactorrhea. A large body of noncomparative literature showed dopamine agonists improved other patient-important outcomes. Low-to-moderate quality evidence supports improved outcomes with surgery and radiotherapy compared to no treatment in patients who were resistant to or intolerant of dopamine agonists.
Conclusion
Our results provide evidence to support the use of dopamine agonists in reducing prolactin levels and persistent hyperprolactinemia, with cabergoline proving more efficacious than bromocriptine. Radiotherapy and surgery are useful in patients with resistance or intolerance to dopamine agonists.
doi:10.1186/2046-4053-1-33
PMCID: PMC3483691  PMID: 22828169
Treatment; Hyperprolactinemia; Macroprolactinoma; Microprolactinoma
6.  The association of hypertriglyceridemia with cardiovascular events and pancreatitis: a systematic review and meta-analysis 
Background
Hypertriglyceridemia may be associated with important complications. The aim of this study is to estimate the magnitude of association and quality of supporting evidence linking hypertriglyceridemia to cardiovascular events and pancreatitis.
Methods
We conducted a systematic review of multiple electronic bibliographic databases and subsequent meta-analysis using a random effects model. Studies eligible for this review followed patients longitudinally and evaluated quantitatively the association of fasting hypertriglyceridemia with the outcomes of interest. Reviewers working independently and in duplicate reviewed studies and extracted data.
Results
35 studies provided data sufficient for meta-analysis. The quality of these observational studies was moderate to low with fair level of multivariable adjustments and adequate exposure and outcome ascertainment. Fasting hypertriglyceridemia was significantly associated with cardiovascular death (odds ratios (OR) 1.80; 95% confidence interval (CI) 1.31-2.49), cardiovascular events (OR, 1.37; 95% CI, 1.23-1.53), myocardial infarction (OR, 1.31; 95% CI, 1.15-1.49), and pancreatitis (OR, 3.96; 95% CI, 1.27-12.34, in one study only). The association with all-cause mortality was not statistically significant.
Conclusions
The current evidence suggests that fasting hypertriglyceridemia is associated with increased risk of cardiovascular death, MI, cardiovascular events, and possibly acute pancreatitis.
Précis: hypertriglyceridemia is associated with increased risk of cardiovascular death, MI, cardiovascular events, and possibly acute pancreatitis
doi:10.1186/1472-6823-12-2
PMCID: PMC3342117  PMID: 22463676
Hypertriglyceridemia; Cardiovascular disease; Pancreatitis; Systematic reviews and meta-analysis

Results 1-6 (6)