Addressing the Missing Links in Cardiovascular Aging.

The aim of this manuscript is to provide a review of available options to enhance cardiovascular health and prevent cardiovascular disease (CVD) in the aging population using a systems-biology approach. These include the role of the gut microbiome, the early identification and removal of environmental toxins, and finally age related sex hormones and supplement replacement which all influence aging. Implementing such a comprehensive approach has the potential to facilitate earlier risk assessment, disease prevention, and even improve mortality. Further study in these areas will continue to advance our understanding and refine therapeutic interventions for a healthier cardiovascular aging process.

Does the duration of ambulatory consultations affect the quality of healthcare? A systematic review.

BACKGROUND: The objective is to examine and synthesise the best available experimental evidence about the effect of ambulatory consultation duration on quality of healthcare. METHODS: We included experimental studies manipulating the length of outpatient clinical encounters between adult patients and clinicians (ie, therapists, pharmacists, nurses, physicians) to determine their effect on quality of care (ie, effectiveness, efficiency, timeliness, safety, equity, patient-centredness and patient satisfaction). INFORMATION SOURCES: Using controlled vocabulary and keywords, without restriction by language or year of publication, we searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials and Database of Systematic Reviews and Scopus from inception until 15 May 2023. RISK OF BIAS: Cochrane Risk of Bias instrument. DATA SYNTHESIS: Narrative synthesis. RESULTS: 11 publications of 10 studies explored the relationship between encounter duration and quality. Most took place in the UK's general practice over two decades ago. Study findings based on very sparse and outdated evidence-which suggested that longer consultations improved indicators of patient-centred care, education about prevention and clinical referrals; and that consultation duration was inconsistently related to patient satisfaction and clinical outcomes-warrant low confidence due to limited protections against bias and indirect applicability to current practice. CONCLUSION: Experimental evidence for a minimal or optimal duration of an outpatient consultation is sparse and outdated. To develop evidence-based policies and practices about encounter length, randomised trials of different consultation lengths-in person and virtually, and with electronic health records-are needed. TRIAL REGISTRATION NUMBER: OSF Registration DOI:10.17605/OSF.IO/EUDK8.

Effect of Shared Decision-Making for Stroke Prevention on Treatment Adherence and Safety Outcomes in Patients With Atrial Fibrillation: A Randomized Clinical Trial.

Background Guidelines promote shared decision-making (SDM) for anticoagulation in patients with atrial fibrillation. We recently showed that adding a within-encounter SDM tool to usual care (UC) increases patient involvement in decision-making and clinician satisfaction, without affecting encounter length. We aimed to estimate the extent to which use of an SDM tool changed adherence to the decided care plan and clinical safety end points. Methods and Results We conducted a multicenter, encounter-level, randomized trial assessing the efficacy of UC with versus without an SDM conversation tool for use during the clinical encounter (Anticoagulation Choice) in patients with nonvalvular atrial fibrillation considering starting or reviewing anticoagulation treatment. We conducted a chart and pharmacy review, blinded to randomization status, at 10 months after enrollment to assess primary adherence (proportion of patients who were prescribed an anticoagulant who filled their first prescription) and secondary adherence (estimated using the proportion of days for which treatment was supplied and filled for direct oral anticoagulant, and as time in therapeutic range for warfarin). We also noted any strokes, transient ischemic attacks, major bleeding, or deaths as safety end points. We enrolled 922 evaluable patient encounters (Anticoagulation Choice=463, and UC=459), of which 814 (88%) had pharmacy and clinical follow-up. We found no differences between arms in either primary adherence (78% of patients in the SDM arm filled their first prescription versus 81% in UC arm) or secondary adherence to anticoagulation (percentage days covered of the direct oral anticoagulant was 74.1% in SDM versus 71.6% in UC; time in therapeutic range for warfarin was 66.6% in SDM versus 64.4% in UC). Safety outcomes, mostly bleeds, occurred in 13% of participants in the SDM arm and 14% in the UC arm. Conclusions In this large, randomized trial comparing UC with a tool to promote SDM against UC alone, we found no significant differences between arms in primary or secondary adherence to anticoagulation or in clinical safety outcomes. Registration URL: https://www.clinicaltrials.gov; Unique identifier: clinicaltrials.gov. Identifier: NCT02905032.

Women's Values and Preferences Regarding Osteoporosis Treatments: A Systematic Review.

BACKGROUND: Several treatments are available to reduce the risk of fragility fractures associated with osteoporosis. The choice of treatment requires knowledge of patients' values and preferences. The aim of the present study was to summarize what is known about the values and preferences relevant to the management of osteoporosis in women. METHODS: We conducted a comprehensive search of several databases for studies reported in any language that had included women who had already started or were about to start any pharmacological therapy for osteoporosis. Pairs of reviewers independently selected the studies and extracted the data. The results were synthesized narratively. RESULTS: We included 26 studies reporting on 15,348 women (mean age, 66 years). The women considered the effectiveness and adverse events equally, followed by the convenience of taking the drug and its effect on daily routine (less frequent dosing was preferred, the oral route was preferred, and the injectable route was preferred over oral if given less frequently). The treatment cost and duration were less important factors for decision making. Fear of breast cancer and fear of resuming uterine bleeding were common reasons for not choosing estrogen therapy. Calcium and vitamin D were viewed as safe and natural. Across the studies, the preferences were not affected by age, previous drug exposure, or employment status. CONCLUSIONS: Women starting osteoporosis medications value effectiveness and side effects equally and prefer medications given less frequently. Injectable drugs appear acceptable if given less frequently. More research on patient values and preferences is needed to guide decision making in osteoporosis.

Developing a Conversation Aid to Support Shared Decision Making: Reflections on Designing Anticoagulation Choice.

Patient-centered care requires that treatments respond to the problematic situation of each patient in a manner that makes intellectual, emotional, and practical sense, an achievement that requires shared decision making (SDM). To implement SDM in practice, tools-sometimes called conversation aids or decision aids-are prepared by collating, curating, and presenting high-quality, comprehensive, and up-to-date evidence. Yet, the literature offers limited guidance for how to make evidence support SDM. Herein, we describe our approach and the challenges encountered during the development of Anticoagulation Choice, a conversation aid to help patients with atrial fibrillation and their clinicians jointly consider the risk of thromboembolic stroke and decide whether and how to respond to this risk with anticoagulation.

Shared decision-making in atrial fibrillation: navigating complex issues in partnership with the patient.

Atrial fibrillation (AF) is an important risk factor for stroke. Although anticoagulation is effective in mitigating this risk, many high-risk patients are not anticoagulated in routine practice. Furthermore, as many as 50% of those who are prescribed an anticoagulant stop treatment within a year. This under treatment may be due, in part, to difficulty in navigating difficult decisions about initiating potentially lifelong therapy with significant costs, potential risks, and impact on daily life. To address these challenges, the most recent American guidelines issued a class I recommendation to use shared decision-making (SDM) to individualize patients' antithrombotic care. The call by the major cardiovascular organizations for SDM is in an effort to improve quality of care by promoting decisions that reflect what is best for an individual patient based on their stroke and bleeding risks, as well as their comorbid conditions and socio-personal context. SDM is readily applicable to current cardiovascular practice, but ongoing work will be needed to determine whether brief, evidence-based, and patient-oriented tools are able to support thoughtful, patient-centered decision-making and, ultimately, improve the rates of appropriate treatment initiation and adherence.

Patients' knowledge about the outcomes of thyroid biopsy: a patient survey.

PURPOSE: Fine-needle aspiration biopsy of the thyroid is an increasingly common outpatient procedure. Patients are counseled about the indications and risks of this procedure and informed consent is obtained. We aimed to assess the extent to which patients acquired necessary knowledge during this process. METHODS: Survey study conducted in a thyroid nodule clinic at a referral center. Adult patients who had just undergone a thyroid biopsy were asked to complete a survey, including eight questions regarding the indications and potential outcomes of thyroid biopsy. The main outcome of the study was to assess the patients' knowledge based on the response to each individual survey question. RESULTS: Two-hundred and ninety-seven patients were eligible, of which 196 (66%) completed the survey: most were women (76%), had adequate reading health literacy (95%) and a mean age of 58 years. Although 86% of patients correctly identified evaluation for thyroid cancer as the main indication for their biopsy, 56% were not aware of the likelihood of this diagnosis. Almost all (>90%) of respondents knew that results could be benign or malignant; fewer were aware of non-diagnostic (71%) or indeterminate (68%) outcomes, or of the need for additional diagnostic testing after the biopsy (33%). CONCLUSIONS: After undergoing thyroid biopsy, a high proportion of well-educated patients remained unaware of their risk for thyroid cancer, potential outcomes, and downstream consequences of their biopsy. This quality gap raises the possibility that informed consent procedures that meet legal standards may leave patients undergoing thyroid biopsy paradoxically uninformed.

Shared decision making for stroke prevention in atrial fibrillation: study protocol for a randomized controlled trial.

BACKGROUND: Nonvalvular atrial fibrillation (AF) is a common ongoing health problem that places patients at risk of stroke. Whether and how a patient addresses this risk depends on each patient's goals, context, and values. Consequently, leading cardiovascular societies recommend using shared decision making (SDM) to individualize antithrombotic treatment in patients with AF. The aim of this study is to assess the extent to which the ANTICOAGULATION CHOICE conversation tool promotes high-quality SDM and influences anticoagulation uptake and adherence in patients with AF at risk of strokes. METHODS: This study protocol describes a multicenter, encounter-level, randomized trial to assess the effect of using the ANTICOAGULATION CHOICE conversation tool in the clinical encounter, compared to usual care. The participating centers include an academic hospital system, a suburban community group practice, and an urban safety net hospital, all in Minnesota, USA. Patients with ongoing nonvalvular AF at risk of strokes (CHA2DS2-VASc score ≥ 1 in men, or ≥ 2 in women) will be eligible for participation. We aim to include 999 patients and their clinicians. The primary outcome is the quality of SDM as perceived by participants, and as assessed by a post-encounter survey that ascertains (a) knowledge transfer, (b) concordance of the decision made, (c) quality of communication, and (d) satisfaction with the decision-making process. Recordings of encounters will be reviewed to assess the extent of patient involvement and how participants use the tool (fidelity). Anticoagulant use, choice of agent, and adherence will be drawn from patients' medical and pharmacy records. Strokes and bleeding events will be drawn from patient records. DISCUSSION: This study will provide a valid and precise measure of the effect of the ANTICOAGULATION CHOICE conversation tool on SDM quality and processes, and on the treatment choices and adherence to therapy among AF patients at risk of stroke. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02905032 . Registered on 9 September 2016.

Perspectives, Decision Making, and Final Mode of Delivery in Pregnant Women With a Previous C-Section in a General Hospital in Peru: Prospective Analysis.

Objective: Explore the perspectives, decision-making process, and final mode of delivery among pregnant women with a previous C-section (Cesarean section) in a general public sector hospital in Lima, Peru. Methods: A qualitative prospective study using semistructured interviews at two time points in the outpatient obstetrics and gynecology clinic of a public sector, university-affiliated reference hospital in Lima, Peru. Seventeen adult pregnant women with a prior C-section who were deemed by their attending obstetrician to be candidates for a trial of labor were interviewed. The first interview was between 37 and 38 weeks of pregnancy, and the second interview was 24 to 48 hours after delivery. MAIN OUTCOME MEASURES: Predelivery decision-making process and final mode of delivery. Results: Among the 17 participants, about half (9) of the participants stated that the physician explained that they had two approaches for delivery, a trial of labor after C-section (TOLAC) or elective repeated C-section (ERCD). Two women stated that their respective providers explained only one option, either an ERCD or TOLAC. However, 6 women did not receive any information from their providers about their delivery options. Of the 10 participants that decided TOLAC, 8 ended up having a C-section, and of the 7 patients that had planned an ERCD, 1 ended up having a vaginal delivery. Conclusion: Many participants affirmed that they made the decision about their approach of delivery. However, most of the participants that decided a TOLAC ended up having a C-section because of complications during the final weeks of pregnancy or during labor.

PCI Choice Decision Aid for Stable Coronary Artery Disease: A Randomized Trial.

BACKGROUND: Percutaneous coronary intervention (PCI) for stable coronary artery disease does not reduce the risk of death and myocardial infarction compared with optimal medical therapy (OMT), but many patients think otherwise. PCI Choice, a decision aid (DA), was designed for use during the clinical visit and includes information on quality of life and mortality outcomes for PCI with OMT versus OMT alone for stable coronary artery disease. METHODS AND RESULTS: We conducted a randomized trial to assess the impact of the PCI Choice DA compared with usual care when there is a choice between PCI and optimal medical therapy. Primary outcomes were patient knowledge and decisional conflict, and the secondary outcome was an objective measure of shared decision making. A total of 124 patients were eligible for final analysis. Knowledge was higher among patients receiving the DA compared with usual care (60% DA; 40% usual care; P=0.034), and patients felt more informed (P=0.043). Other measures of decisional quality were not improved, and engagement of the patient by the clinician in shared decision making did not change with use of the DA. There was evidence that clinicians used the DA as an educational tool. CONCLUSIONS: The PCI Choice DA improved patient knowledge but did not significantly impact decisional quality. Further work is needed to effectively address clinician knowledge gaps in shared decision-making skills, even in the context of carefully designed DAs. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT01771536.

Shared decision making in senior medical students: results from a national survey.

PURPOSE: To explore perceptions and experiences of Peruvian medical students about observed, preferred, and feasible decision-making approaches. METHODS: We surveyed senior medical students from 19 teaching hospitals in 4 major cities in Peru. The self-administered questionnaire collected demographic information, current approach, exposure to role models for and training in shared decision making, and perceptions of the pertinence and feasibility of the different decision-making approaches in general as well as in challenging scenarios. RESULTS: A total of 327 senior medical students (51% female) were included. The mean age was 25 years. Among all respondents, 2% reported receiving both theoretical and practical training in shared decision making. While 46% of students identified their current decision-making approach as clinician-as-perfect-agent, 50% of students identified their teachers with the paternalistic approach. Remarkably, 53% of students thought shared decision making should be the preferred approach and 50% considered it feasible in Peru. Among the 10 challenging scenarios, shared decision making reached a plurality (40%) in only one scenario (terminally ill patients). CONCLUSION: Despite limited exposure and training, Peruvian medical students aspire to practice shared decision making but their current attitude reflects the less participatory approaches they see role modeled by their teachers.

The incremental benefit of functional imaging in pheochromocytoma/paraganglioma: a systematic review.

Computed tomography (CT) and magnetic resonance imaging (MRI) are the major imaging modalities used for the localization of catecholamine-producing tumors (pheochromocytoma and paraganglioma). Functional imaging (FI) offers an alternative approach to localize, evaluate, and stage these tumors. Our objective was to describe the additive benefit of FI studies for patients with pheochromocytoma and paraganglioma (PPG) who have undergone MRI or CT scan evaluation. We searched MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews, and Scopus from database inception through June 2012 for studies that included patients with biochemically proven PPGs who underwent CT or MRI and additional FI for the localization of PPGs. We included 32 studies enrolling a total of 1,264 patients with a mean age of 43-years old. The studies were uncontrolled and evaluated six FI modalities. FI tests provided small additive value to CT/MRI, aiding in the localization of only 24/1,445 primary cases (1.4 %) and 28/805 metastatic cases (3.5 %). In metastatic cases, 6-[F-18]fluoro-L-dihydroxyphenylalanine (DOPA) and fluorodopamine-PET (FDA) were the FI tests most successful at identifying disease missed by CT/MRI, providing additional benefit in 6/60 (10 %) and 5/78 (6.4 %) cases, respectively. No clinically significant findings were observed in any of the predefined subgroups. No study evaluated the impact of FI on the completeness of surgical resection or other patient-important outcomes. Observational evidence suggests that FI tests have a limited additional role in patients with PPGs who have undergone CT/MRI evaluation. However, the role of FI tests in specific subgroups of patients with atypical presentations (metastatic, extra-adrenal) as well as the use of hybrid FI tests should be explored. Further research should also evaluate the impact of FI tests on patient-important outcomes.

Testing for germline mutations in sporadic pheochromocytoma/paraganglioma: a systematic review.

BACKGROUND: The presence of germline mutations in sporadic pheochromocytomas and paragangliomas (SPPs) may change the clinical management of both index patients and their family members. However, the frequency of germline mutations in SPPs is unknown. OBJECTIVE: To describe the frequency of germline mutations in SPPs and to determine the value of testing index patients and their family members for these mutations. METHODS: We searched databases through June 2012 for observational studies of patients with SPPs who underwent germline genetic testing. The criteria used to define sporadic tumours were (i) the absence of a family history of PCC/PG, (ii) the absence of syndromic features, (iii) the absence of bilateral disease and (iv) the absence of metastatic disease. RESULTS: We included 31 studies including 5031 patients (mean age 44). These patients received tests for any of these ten mutations: SDHAF2, RET, SDHD, SDHB, SDHC, VHL, TMEM127, MAX, Isocitrate Dehydrogenase Mutation (IDH) and NF1. The overall frequency of germline mutation in SPP was 551 of 5031 or 11%; when studies with patients fulfilling four criteria for sporadic tumours were used, the frequency was 171 of 1332 or 13%. The most common germline mutation was SDHB 167 of 3611 (4·6%). Little outcome data were available to assess the benefits of genetic testing in index cases and family members. CONCLUSIONS: The frequency of germline mutations in SPPs is approximately 11-13% and the most common mutations affect less than 1 in 20 patients. The value of testing for germline mutations in patients with SPPs and their family members is unknown, as the balance of potential benefits and harms remains unclear.

The efficacy of resiliency training programs: a systematic review and meta-analysis of randomized trials.

IMPORTANCE: Poor mental health places a burden on individuals and populations. Resilient persons are able to adapt to life's challenges and maintain high quality of life and function. Finding effective strategies to bolster resilience in individuals and populations is of interest to many stakeholders. OBJECTIVES: To synthesize the evidence for resiliency training programs in improving mental health and capacity in 1) diverse adult populations and 2) persons with chronic diseases. DATA SOURCES: Electronic databases, clinical trial registries, and bibliographies. We also contacted study authors and field experts. STUDY SELECTION: Randomized trials assessing the efficacy of any program intended to enhance resilience in adults and published after 1990. No restrictions were made based on outcome measured or comparator used. DATA EXTRACTION AND SYNTHESIS: Reviewers worked independently and in duplicate to extract study characteristics and data. These were confirmed with authors. We conducted a random effects meta-analysis on available data and tested for interaction in planned subgroups. MAIN OUTCOMES: The standardized mean difference (SMD) effect of resiliency training programs on 1) resilience/hardiness, 2) quality of life/well-being, 3) self-efficacy/activation, 4) depression, 5) stress, and 6) anxiety. RESULTS: We found 25 small trials at moderate to high risk of bias. Interventions varied in format and theoretical approach. Random effects meta-analysis showed a moderate effect of generalized stress-directed programs on enhancing resilience [pooled SMD 0.37 (95% CI 0.18, 0.57) p = .0002; I2 = 41%] within 3 months of follow up. Improvement in other outcomes was favorable to the interventions and reached statistical significance after removing two studies at high risk of bias. Trauma-induced stress-directed programs significantly improved stress [-0.53 (-1.04, -0.03) p = .03; I2 = 73%] and depression [-0.51 (-0.92, -0.10) p = .04; I2 = 61%]. CONCLUSIONS: We found evidence warranting low confidence that resiliency training programs have a small to moderate effect at improving resilience and other mental health outcomes. Further study is needed to better define the resilience construct and to design interventions specific to it. REGISTRATION NUMBER: PROSPERO #CRD42014007185.

[Shared decision making and minimal disruptive medicine in the management of chronic diseases]. / Toma de decisiones compartidas y medicina mínimamente impertinente en el manejo de las enfermedades crónicas.

Chronic diseases are the leading cause of morbidity and mortality worldwide. These conditions require considerable time investment and resources from the health system in Peru, as well as from patients and their families. Paradoxically, the developed medical strategies for managing these conditions generate a constant and increasing burden for the patient and their environment, which affects quality of life and therapeutic results. In this article, the role of shared decision making and minimal disruptive medicine will be described as strategies to address these problems.

A systematic review of shared decision making interventions in chronic conditions: a review protocol.

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.

The efficacy of resilience training programs: a systematic review protocol.

BACKGROUND: 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. METHODS/DESIGN: 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. DISCUSSION: 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. TRIAL REGISTRATION: PROSPERO registration number: CRD42014007185.

Toma de decisiones compartidas y medicina mínimamente impertinente en el manejo de las enfermedades crónicas / Shared decision making and minimal disruptive medicine in the management of chronic diseases

Las enfermedades crónicas son la causa más importante de morbilidad y mortalidad a nivel mundial. Estas condiciones requieren considerable inversión de tiempo y recursos por parte del sistema de salud en el Perú, así como de los pacientes y sus familiares. Paradójicamente, las estrategias médicas desarrolladas para el manejo de estas condiciones generan una carga constante y creciente para el paciente y su entorno, que repercute en la calidad de vida del paciente y en los resultados terapéuticos. En este artículo describimos el rol de la toma de decisiones compartidas y de la medicina mínimamente impertinente como estrategias para abordar estos problemas.

Chronic diseases are the leading cause of morbidity and mortality worldwide. These conditions require considerable time investment and resources from the health system in Peru, as well as from patients and their families. Paradoxically, the developed medical strategies for managing these conditions generate a constant and increasing burden for the patient and their environment, which affects quality of life and therapeutic results. In this article, the role of shared decision making and minimal disruptive medicine will be described as strategies to address these problems.