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Sex hormones play a role in bone density, cardiovascular health, and wellbeing throughout reproductive lifespan. Women with primary ovarian insufficiency (POI) have lower estrogen levels requiring hormone therapy (HT) to manage symptoms and to protect against adverse long-term health outcomes. Yet, the effectiveness of HT in preventing adverse outcomes has not been systematically assessed. We summarize the evidence regarding effects of HT on bone and cardiovascular health in women with POI. A comprehensive search of the electronic databases MEDLINE, EMBASE, and Scopus was conducted by a medical reference librarian from database inception to January 2016. Randomized trials and observational cohort studies with an estrogen-based HT intervention in women with POI under the age of 40 were included. Reviewers worked independently and in duplicate to assess eligibility and risk of bias, and extract data of interest from each study. The search identified 1670 articles; 12 met inclusion criteria. Four randomized clinical trials and eight cohort studies at high risk of bias enrolled 806 women with POI. The most common HT formulations were transdermal estradiol and oral conjugated equine estrogen combined with medroxyprogesterone acetate. Bone mineral density was the most frequent outcome, with three out of eight studies showing HT associated increase benefits. Only one study reported effects on fractures or vasomotor symptoms and none on cardiovascular mortality. Results regarding lipid profiles were inconsistent. Evidence supporting bone and cardiovascular benefits of HT in women with POI is limited by high risk of bias, reliance on surrogate outcomes, and heterogeneity of trials regarding the formulation, dose, route of administration, and regimen of HT. Further research addressing patient important outcomes such as fractures, stroke, and cardiovascular mortality are crucial to optimize benefits of this therapy.

Patients with ankylosing (AS) often do not have a satisfactory response to, or could not tolerate, non-steroidal anti-inflammatory drugs (NSAIDs). Several biologic agents are available for such patients. However, the comparative efficacy of these treatments remains unknown as head-to-head randomized controlled trials (RCTs) are not available. RCTs examining the efficacy of biologic agents in patients with AS who had inadequate response to, or could not tolerate, NSAIDs were identified. If at least two RCTs were available for a given biologic agent, the pooled odds ratio (OR) and 95% confidence interval (CI) of achieving 20% improvement according to the Ankylosing Spondylitis Assessment Study group response criteria 20 (ASAS20) across trials were calculated. The pooled OR for each biologic agent was then compared to each other using the indirect comparison technique. A total of 14 RCTs of older TNF inhibitors, two RCTs of secukinumab, one RCT of certolizumab, and one RCT of tofacitinib were identified. No significant difference in any indirect comparisons was observed with the p values ranging from 0.12 to 0.74. The likelihood of achieving the ASAS20 response in patients AS who failed or could not tolerate NSAIDs was not significantly different between older TNF inhibitors, secukinumab, certolizumab, and tofacitinib. However, the analysis is limited by the small sample size with only one RCT for certolizumab and tofacitinib.

Counseling for patients with primary hyperparathyroidism (PHPT) and mild hypercalcemia without indications for surgical intervention requires accurate estimates of the potential benefits of parathyroidectomy. We aim to summarize the available evidence regarding the benefits of parathyroidectomy that patients with mild PHPT without indications for surgery experience compared to observation. We searched multiple databases from inception to August 2015. We included randomized controlled trials (RCT) and observational studies that evaluated changes in bone health, quality of life or neuropsychiatric symptoms, or in the risk of nephrolithiasis, cardiovascular events, or death between patients undergoing parathyroidectomy or active surveillance. Eight studies were eligible. Risk differences were not significant, in part due to lack of events (fractures, nephrolithiasis, cardiovascular events, or deaths). No significant differences were observed across measures of bone health, quality of life, and neuropsychiatric symptoms. A single RCT evaluating bone mineral density (BMD) changes at 5 years found a small statistically significant effect favoring parathyroidectomy. Patients with mild PHPT without indications for surgery experience a limited number of adverse consequences during short-term follow-up limiting our ability to estimate the benefit of surgery during this timeframe. This information is helpful as these patients consider surgery versus active surveillance. Long-term data is warranted to determine who benefits in the long run from surgical intervention and the extent to which this benefit affects outcomes that matter to patients.

Patients with Turner syndrome have adverse bone and cardiovascular outcomes from chronic estrogen deficiency. Hence, long-term estrogen replacement therapy is the cornerstone treatment. The estimates of its effect and optimal use, however, remain uncertain. We aimed to summarize the benefits and harms of estrogen replacement therapy on bone, cardiovascular, vasomotor and quality of life outcomes in patients with Turner syndrome. A comprehensive search of four databases was performed from inception through January 2016. Randomized clinical trials and observational cohort studies studying the effect of estrogen replacement therapy in patients with Turner syndrome under the age of 40 were included. Independently and in duplicate reviewers selected studies, extracted data and assessed risk of bias. Subgroup analyses were based on route of administration and type of estrogen formulation. Twenty-five studies at moderate to high risk of bias (12 randomized trials, 13 cohort studies) with 771 patients were included. Using random-effects models, estrogen replacement therapy showed an increase in bone mineral density [weighted mean change from baseline 0.09 g/cm2 (0.04-0.14)] that differed by type of estrogen but not route of administration. Oral estrogen replacement therapy showed a higher increase in high density lipoprotein cholesterol levels when compared to transdermal [weighted mean difference 9.33 mg/dl (4.82-13.85)] with no significant effect on other lipid fractions. The current evidence suggests possible benefit of estrogen replacement therapy on bone mineral density and high density lipoprotein cholesterol. Whether this improvement translates into changes in patient important outcomes (cardiovascular events or fractures) remains uncertain. Larger randomized clinical trials with direct comparisons on patient important outcomes are necessary.

Parathyroidectomy is a definitive treatment for primary hyperparathyroidism. Patients contemplating this intervention will benefit from knowledge regarding the expected outcomes and potential risks of the currently available surgical options. To appraise and summarize the available evidence regarding benefits and harms of minimally invasive parathyroidectomy (MIP) and bilateral neck exploration (BNE). A comprehensive search of multiple databases (MEDLINE, EMBASE, and Scopus) from each database’s inception to September 2014 was performed. Eligible studies evaluated patients with primary hyperparathyroidism undergoing MIP or BNE. Reviewers working independently and in duplicate extracted data and assessed the risk of bias. We identified 82 observational studies and 6 randomized trials at moderate risk of bias. Most of them reported outcomes after MIP (n = 71). Using random-effects models to pool results across studies, the cure rate was 98 % (95 % CI 97–98 %, I 2 = 10 %) with BNE and 97 % (95 % CI 96–98 %, I 2 = 86 %) with MIP. Hypocalcemia occurred in 14 % (95 % CI 10–17 % I 2 = 93 %) of the BNE cases and in 2.3 % (95 % CI 1.6–3.1 %, I 2 = 87 %) with MIP (P

To perform a systematic review and meta-analysis of clinical trials evaluating the efficacy and safety of midodrine in orthostatic hypotension (OH). We searched major databases and related conference proceedings through June 30, 2012. Two reviewers independently selected studies and extracted data. Random-effects meta-analysis was used to pool the outcome measures across studies. Seven trials were included in the efficacy analysis (enrolling 325 patients, mean age 53 years) and two additional trials were included in the safety analysis. Compared to placebo, the mean change in systolic blood pressure was 4.9 mmHg (p = 0.65) and the mean change in mean arterial pressure from supine to standing was −1.7 mmHg (p = 0.45). The change in standing systolic blood pressure before and after giving midodrine was 21.5 mmHg (p

Background Life and healthcare demand work from patients, more so from patients living with multimorbidity. Patients must respond by mobilizing available abilities and resources, their so-called capacity. We sought to summarize accounts of challenges that reduce patient capacity to access or use healthcare or to enact self-care while carrying out their lives. Methods We conducted a systematic review and synthesis of the qualitative literature published since 2000 identifying from MEDLINE, EMBASE, Psychinfo, and CINAHL and retrieving selected abstracts for full text assessment for inclusion. After assessing their methodological rigor, we coded their results using a thematic synthesis approach. Results The 110 reports selected, when synthesized, showed that patient capacity is an accomplishment of interaction with (1) the process of rewriting their biographies and making meaningful lives in the face of chronic condition(s); (2) the mobilization of resources; (3) healthcare and self-care tasks, particularly, the cognitive, emotional, and experiential results of accomplishing these tasks despite competing priorities; (4) their social networks; and (5) their environment, particularly when they encountered kindness or empathy about their condition and a feasible treatment plan. Conclusion Patient capacity is a complex and dynamic construct that exceeds “resources” alone. Additional work needs to translate this emerging theory into useful practice for which we propose a clinical mnemonic (BREWS) and the ICAN Discussion Aid. Electronic supplementary material The online version of this article (doi:10.1186/s12875-016-0525-9) contains supplementary material, which is available to authorized users.

BACKGROUND: Learner feedback is the primary method for evaluating clinical faculty, despite few existing standards for measuring learner assessments. OBJECTIVE: To review the published literature on instruments for evaluating clinical teachers and to summarize themes that will aid in developing universally appealing tools. DESIGN: Searching 5 electronic databases revealed over 330 articles. Excluded were reviews, editorials, and qualitative studies. Twenty-one articles describing instruments designed for evaluating clinical faculty by learners were found. Three investigators studied these papers and tabulated characteristics of the learning environments and validation methods. Salient themes among the evaluation studies were determined. MAIN RESULTS: Many studies combined evaluations from both outpatient and inpatient settings and some authors combined evaluations from different learner levels. Wide ranges in numbers of teachers, evaluators, evaluations, and scale items were observed. The most frequently encountered statistical methods were factor analysis and determining internal consistency reliability with Cronbach’s α. Less common methods were the use of test-retest reliability, interrater reliability, and convergent validity between validated instruments. Fourteen domains of teaching were identified and the most frequently studied domains were interpersonal and clinical-teaching skills. CONCLUSIONS: Characteristics of teacher evaluations vary between educational settings and between different learner levels, indicating that future studies should utilize more narrowly defined study populations. A variety of validation methods including temporal stability, interrater reliability, and convergent validity should be considered. Finally, existing data support the validation of instruments comprised solely of interpersonal and clinical-teaching domains.

Background Chronic conditions are a major source of morbidity, mortality and cost worldwide. Shared decision making is one way to improve care for patients with chronic conditions. Although it has been widely studied, the effect of shared decision making in the context of chronic conditions is unknown. Methods/Design We will perform a systematic review with the objective of determining the effectiveness of shared decision making interventions for persons diagnosed with chronic conditions. We will search the following databases for relevant articles: PubMed, Scopus, Ovid MEDLINE, Ovid EMBASE, Ovid EBM Reviews CENTRAL, CINAHL, and Ovid PsycInfo. We will also search clinical trial registries and contact experts in the field to identify additional studies. We will include randomized controlled trials studying shared decision making interventions in patients with chronic conditions who are facing an actual decision. Shared decision making interventions will be defined as any intervention aiming to facilitate or improve patient and/or clinician engagement in a decision making process. We will describe all studies and assess their quality. After adjusting for missing data, we will analyze the effect of shared decision making interventions on outcomes in chronic conditions overall and stratified by condition. We will evaluate outcomes according to an importance ranking informed by a variety of stakeholders. We will perform several exploratory analyses including the effect of author contact on the estimates of effect. Discussion We anticipate that this systematic review may have some limitations such as heterogeneity and imprecision; however, the results will contribute to improving the quality of care for individuals with chronic conditions and facilitate a process that allows decision making that is most consistent with their own values and preferences. Trial registration PROSPERO Registration Number: CRD42013005784

Resilience has been defined as the ability of individuals to manage and adapt to stress and life challenges. Training programs that develop and/or enhance resilience may have efficacy in improving health, well-being, and quality of life. Because patients with chronic conditions must reliably self-manage their health, strategies to bolster resilience in this population may be of particular value. The objectives of this systematic review are to synthesize the evidence of resilience training program efficacy in improving outcomes related to quality of life, self-efficacy and activation, and resilience and coping ability in: 1) diverse adult populations; and 2) patients with chronic conditions. We will conduct a systematic review of randomized controlled trials assessing the efficacy of any program designed to enhance resilience in adults that measure any outcome against any comparator. We will search multiple electronic databases, trial registries, bibliographies, and will contact authors and experts to identify studies. We will use systematic review software to independently and in duplicate screen reports and extract data. We will extract characteristics of the study populations, interventions, comparators, outcomes, and quality/risk of bias. Primary, patient reported outcomes will be categorized into domains of quality of life, self-efficacy, and resilience. Secondary outcomes will be considered based on findings of the review. We will attempt meta-analysis by pooling standardized mean differences and minimally important differences (MIDs), when possible. Planned trial subgroup analyses are: 1) studies of patients with chronic conditions; 2) studies with placebo controls; 3) studies with similar intervention characteristics; and 4) studies with common lengths of follow-up. This study is intended to accumulate the evidence for resilience training programs in improving quality of life, resilience, and self-efficacy for care management, particularly among adult patients with chronic conditions. Its findings will be valuable to policy-makers, funding agencies, clinicians, and patients seeking innovative and effective ways to achieve patient-centered care. PROSPERO registration number: CRD42014007185 .

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.

Background Obtaining informed consent is a cornerstone of biomedical research, yet participants comprehension of presented information is often low. The most effective interventions to improve understanding rates have not been identified. Purpose To systematically analyze the random controlled trials testing interventions to research informed consent process. The primary outcome of interest was quantitative rates of participant understanding; secondary outcomes were rates of information retention, satisfaction, and accrual. Interventional categories included multimedia, enhanced consent documents, extended discussions, test/feedback quizzes, and miscellaneous methods. Methods The search spanned from database inception through September 2010. It was run on Ovid MEDLINE, Ovid EMBASE, Ovid CINAHL, Ovid PsycInfo and Cochrane CENTRAL, ISI Web of Science and Scopus. Five reviewers working independently and in duplicate screened full abstract text to determine eligibility. We included only RCTs. 39 out of 1523 articles fulfilled review criteria (2.6%), with a total of 54 interventions. A data extraction form was created in Distiller, an online reference management system, through an iterative process. One author collected data on study design, population, demographics, intervention, and analytical technique. Results Meta-analysis was possible on 22 interventions: multimedia, enhanced form, and extended discussion categories; all 54 interventions were assessed by review. Meta-analysis of multimedia approaches was associated with a non-significant increase in understanding scores (SMD 0.30, 95% CI, -0.23 to 0.84); enhanced consent form, with significant increase (SMD 1.73, 95% CI, 0.99 to 2.47); and extended discussion, with significant increase (SMD 0.53, 95% CI, 0.21 to 0.84). By review, 31% of multimedia interventions showed significant improvement in understanding; 41% for enhanced consent form; 50% for extended discussion; 33% for test/feedback; and 29% for miscellaneous.Multiple sources of variation existed between included studies: control processes, the presence of a human proctor, real vs. simulated protocol, and assessment formats. Conclusions Enhanced consent forms and extended discussions were most effective in improving participant understanding. Interventions of all categories had no negative impact on participant satisfaction or study accrual. Identification of best practices for studies of informed consent interventions would aid future systematic comparisons.