Future Clinical Practice Guidelines Research Articles

Unlocking equity: assessing for gaps in cardiovascular guidelines for pregnant women

Abstract Introduction Cardiovascular disease is the primary contributor to pregnancy-related fatalities in the United States, displaying a gradual rise over the years. Pregnancy introduces unique physiological changes that can impact pre-existing cardiovascular conditions and trigger new complications. Considerable inequalities in pregnancy-related mortality built on race and ethnicity are unmistakable, with the highest rates observed in black non-Hispanic women. Purpose This study aims to evaluate current gaps in racial/ethnic minority participation in randomized control trials (RCTs) cited in major cardiology guidelines. Methods Citations in the 2018 ESC Guidelines for the Management of Cardiovascular Diseases During Pregnancy were evaluated for RCTs. The American Heart Association and American College of Cardiology guidelines were also examined. Manuscripts and supplementary data were examined for participant-level racial or ethnic data, including age, race, and ethnicity. Results Thirteen RCTs, representing 20,665 participants, spanning the period from 2002 to 2017, were reviewed. European guidelines referenced thirteen of the RCTS, while American guidelines referenced two RCTs. The average age of participants was 31 years old. Most of the trials were conducted in Europe (46%). Forty-six percent of RCTs reported race/ethnicity breakdowns, with pooled participation showing a majority of non-Hispanic white participants (76.7%), with limited representation from other racial groups (table). Eight trials focused on hypertension, two on venous thromboembolism, and one on heart failure. Conclusion Pregnant women are frequently excluded from RCTs due to concerns about potential harm to the developing fetus. Consequently, current guidelines lack robust RCTs tailored to pregnant women with various cardiovascular diseases. The underrepresentation of ethnic minorities in cardiovascular disease trials contributes to a scarcity of evidence-based recommendations for managing these conditions during pregnancy and postpartum. Future clinical practice guidelines should advocate for a more personalized and evidence-based approach to managing cardiovascular diseases in pregnancy.

Collaborative and integrated working between general practice and community pharmacies: A realist review of what works, for whom, and in which contexts.

Collaborative and integrated (C + I) working between general practice and community pharmacies has the potential to increase accessibility to services, improve service efficiency and quality of care, and reduce health care expenditures. Many existing studies report challenges and complexities inherent in establishing effective C + I ways of working. The aim of our review is to understand how, when and why working arrangements between General Practitioners (GP) and Community Pharmacists (CP) can provide the conditions necessary for effective communication, decision-making, and C + I working. We conducted a realist review to explore the key contextual factors and mechanisms through which GP-CP C + I working may be achieved. MEDLINE, Embase, CINAHL, PsycINFO, HMIC, Web of Science, IBSS, ASSIA, Sociological Abstracts, Sociology Database and the King's Fund Library Database were searched for articles and grey literature published between January 2000 and April 2022. A total of 136 documents were included in the final synthesis. Our findings highlight the importance of mutually beneficial remuneration models to support effective integration of services; supportive organisational cultures and values; flexible and agile IT systems/technologies; adequate physical infrastructure and space design to support multidisciplinary teamworking; the importance of establishing patient's trust in collaborative processes between GP-CP; and the need to acknowledge, support and utilise effective triadic relationships. Our research generates new insights regarding how, why and in which contexts C + I working can be achieved between GPs and CPs. The findings of our review can be used to inform future policy, research and clinical practice guidelines for designing and delivering C + I care.

European Journal of Vascular and Endovascular Surgery Publication Standards for Reporting Vascular Surgical Research

Manuscripts submitted to the European Journal of Vascular and Endovascular Surgery (EJVES) often contain shortcomings in baseline scientific principles and incorrectly applied methodology. Consequently, the editorial team is forced to offer post hoc repair in an attempt to support the authors to improve their manuscripts. This repair could theoretically have been prevented by providing more clear definitions and reporting standards to serve researchers when planning studies and eventually writing their manuscripts. Therefore, here we summarise the general principles for EJVES reporting standards. These reporting standards did not follow a systematic approach but reflect the common opinion of the current senior and section editors team. This team decided to only include recommendations regarding the most common pathologies in vascular surgery in this first edition of reporting standards, namely carotid artery disease, abdominal aortic aneurysm (AAA), peripheral arterial occlusive disease (PAOD), and chronic venous disease. In future editions, we plan to expand the areas of research. We present (1) a common set of minimum but required reporting standards applicable to every report, e.g., patient characteristics, study design, treatment environment, selection criteria, core outcomes of interventions such as 30 day death and morbidity, and measures for completeness of data including outcome information, and (2) a common set of minimum reporting standards for four vascular areas. The editors of the EJVES propose universally accepted definitions and reporting standards for carotid artery disease, AAA, PAOD, and chronic venous disease. This will enable the development of a convincing body of evidence to aid future clinical practice guidelines and drive clinical practice in the right direction. These first ever publication and reporting standards for EJVES aim to improve future research in our journal.

Application of the 2022 American Thoracic/European Respiratory Society/Japanese Respiratory Society/Associatión Latinoamericana de Tórax (ATS/ERS/JRS/ALAT) idiopathic pulmonary fibrosis and progressive pulmonary fibrosis clinical practice guideline to a Canadian population: An opinion piece

In 2022, the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS), and Associatión Latinoamericana de Tórax (ALAT) produced an updated clinical practice guideline on the diagnosis and management of idiopathic pulmonary fibrosis (IPF), also defining and making treatment recommendations for progressive pulmonary fibrosis (PPF). In this review, we summarize and highlight aspects of this guideline that are most relevant to Canadians. New recommendations in IPF include the use of transbronchial lung cryobiopsy as an alternative to surgical lung biopsy and a recommendation against antacid medications in asymptomatic patients. The guideline also recommends treating PPF with nintedanib, an antifibrotic currently approved for IPF. The guideline definition of PPF should be adopted in Canada, although with flexibility in physiologic parameters of the PPF definition and increased support for community respirologists to care for these patients. Although pirfenidone was not recommended in the guideline for the treatment of PPF, there are multiple clinical trials that support its use as a second-line treatment for PPF. It is imperative that Canadian resources continue to support knowledge generation of this complex group of patients and that Canadians continue to have ongoing involvement in the development of future international clinical practice guidelines.

Clinical Practice Guideline on Acupuncture and Moxibustion: Adult Major Depressive Disorder (Mild-Moderate Degree): Determination of clinical questions: 《针灸临床实践指南: 成人轻中度抑郁症》: 临床问题的确定

Determining clinical questions is fundamental to the development of clinical practice guidelines (CPGs), which bridges the initial phases and the final recommendations. It is essential for evidence retrieval and the formulation of recommendations. The scientific rigor and precision in determination of clinical questions directly influence the future implementation and applicability of guidelines. In 2020, the World Federation of Acupuncture-Moxibustion Societies initiated the project of clinical practice guideline on acupuncture and moxibustion for adult major depressive disorder (mild-moderate degree) to address clinical and medical decision-making issues in acupuncture treatment for adult mild to moderate major depressive disorder. This CPG provides systematic recommendations based on clinical evidence, patient values, and other factors, aiding decision-makers, clinicians, and patients in selecting appropriate interventions. This paper discusses and analyzes the determination process of clinical questions, and the related issues during the development of this guideline, aiming to provide a reference for determining clinical questions and developing CPGs in the field of acupuncture and exploring more scientific tools and methods for determining clinical questions in future CPGs.

INFORM-AF II-Phase 1 pilot randomised controlled trial evaluating the effect of an atrial fibrillation digital education programme: study protocol.

To evaluate the effect of a novel, co-designed, digital AF educational program, 'INFORM-AF', to reduce re-hospitalisation of people with AF. The secondary aims are to examine the effect of the intervention on: (a) reducing cardiovascular-related hospitalisation, (b) increasing medication adherence, AF-related knowledge, and Atrial fibrillation (AF)-related quality of life and (c) determining the cost-effectiveness of the intervention. AF is an increasingly prevalent cardiac arrythmia that involves complex clinical management. Comprehensive education is essential for successful self-management of AF and is associated with positive health-related outcomes. There has been an increase in technology-based education for AF. However, its effects on hospitalisation, medication adherence and patient-reported outcomes are unclear. A prospective, randomised (1:1), open-label, blinded-endpoint, multicentre clinical trial. Eligible participants are aged 18 years or above, diagnosed with AF, and own a smartphone. The study will be conducted at two metropolitan hospitals. In the intervention group, participants will receive the AF educational program delivered via Qstream®. In the control group, participants will receive the Stroke Foundation 'Living with AF' booklet. The primary outcome is re-hospitalisation within 12 months from an indexed presentation or hospital admission. This clinical trial is part of a developing program of work that will examine mHealth educational-behavioural interventions on cardiovascular outcomes. Findings from this pilot study will inform the development of a digital educational framework for patients living with AF. There remain many gaps in providing high-quality patient education for patients with AF. This trial will test a new theory-driven, smartphone-based education program on important clinical outcomes, including rehospitalisation. This study evaluates a novel, co-designed, digital AF educational program, 'INFORM-AF', to reduce the re-hospitalisation of people with AF. Study results are expected to be reported in 2025. Findings are expected to inform practice recommendations for AF patient education that may be included in future clinical practice guideline recommendations. SPIRIT Checklist. JL is a consumer co-researcher on the project and provided critical input into intervention design, and feedback and input across the study duration.

Comparison of three diagnostic strategies for suspicion of pulmonary embolism: planar ventilation-perfusion scan (V/Q), CT pulmonary angiography (CTPA) and single photon emission CT ventilation-perfusion scan (SPECT V/Q): a protocol of a randomised controlled trial

IntroductionPulmonary embolism (PE) is a challenge to diagnose and when missed, exposes patients to potentially fatal recurrent events. Beyond CT pulmonary angiography (CTPA) and planar ventilation/perfusion (V/Q) scan, single photon...

The association of the STarT Back Screening Tool and type of leg pain with low back pain disability trajectories: a prospective cohort study

BackgroundMultiple factors influence the recovery process of low back pain (LBP). The identification and increased knowledge of prognostic factors might contribute to a better understanding of the course of LBP. The purpose of this study is to investigate the association of the STarT Back Screening Tool (SBST) risk score and the type of leg pain (non-radiating LBP, referred non-radicular, and radicular radiating leg pain) with the disability trajectory (at baseline, the slope, and recovery at one year) in adults with low back pain.MethodsThis is a prospective cohort study in 347 patients with low back pain who sought physiotherapy care at three primary care practices in the Netherlands. Linear mixed models were estimated to describe the association of the SBST risk score and the type of leg pain with disability at baseline, the slope in the disability trajectory, and at twelve months follow-up.ResultsA medium/high risk score on the SBST is associated with higher baseline disability scores on the Oswestry Disability Index (ODI), faster initial recovery, and still a higher disability ODI score at 12 months follow-up. Non-radicular referred and radicular radiating leg pain were associated with worse baseline disability ODI scores in LBP. This association was not present for the initial recovery or at the 12 months follow-up.ConclusionThe SBST is associated with the LBP recovery trajectory. The SBST might be a useful tool to predict the disability trajectory in a heterogeneous group of people with low back pain in primary care and might, therefore, be recommended in future clinical practice guidelines. The type of leg pain was not associated with the recovery trajectory of LBP. Future research might focus on evaluating different types of leg pain.Trial registrationClinicaltrials.gov: 109,643.

Characteristics and Quality of Traditional Chinese Therapies and Integrative Medicine Clinical Practice Guidelines for Musculoskeletal Disorders Published in Mainland China

Background: Musculoskeletal disorders are prevalent in adults. Traditional Chinese medicine (TCM) and integrative medicine (IM) are commonly used treatments which have clinical practice guidelines (CPGs). This study aimed to determine the characteristics and quality of these CPGs.Methods: CPGs which recommended TCM/IM therapies in musculoskeletal conditions/diseases published in Chinese or English between January 2018 to December 2022 in mainland China were retrieved and analyzed for guideline classification, funding source, conflict of interest, and methodology. Appraisal of Guideline for Research and Evaluation Ⅱ including 6 domains, was applied to assess CPG quality.Results: Of the 50 CPGs included, there were 19 TCM, 5 IM, and 26 western conventional medicine (WCM) guidelines of which osteoporosis (13, 26%), osteoarthritis (11, 22%) and rheumatoid arthritis (6, 12%) were the most frequent diseases. The TCM therapies recommended by the CPGs successively were acupuncture and moxibustion, Chinese patent medicine, and TCM decoction based on syndrome differentiation. Nearly half of the CPGs reported funding source (52%) and conflict of interest (48%). Thirty-six CPGs used the Grading of Recommendations, Assessment, Development, and Evaluations method to present summaries of evidence, the remaining did not report the method. Based on Appraisal of Guideline for Research and Evaluation Ⅱ scores, “clarity of presentation” scored the highest (55%), while “applicability” was the lowest (6%). No CPG was recommended without change, and 23 CPGs were not recommended.Conclusion: The quality of CPGs for musculoskeletal conditions/diseases in China is generally low. Future CPGs should pay more attention to standardized developing procedures.

Predicting physical activity and quality of life in coronary heart disease patients: An 18-month path analysis of motivational and emotional factors.

Investigating factors that promote cardiovascular health outcomes is essential for secondary prevention. In a sample of coronary heart disease patients, we examined the direct and indirect effects of selected psychological factors on physical activity behavior and health-related quality of life (HRQoL) over 18 months. Patient-reported data were collected over three time points. Through structured equation modeling, a longitudinal path analysis was conducted to estimate the indirect effects of baseline HRQoL and cardiac self-efficacy on reported physical activity behavior and HRQoL (evaluated at 18 months) through the mediation of anxiety and depression symptoms, patients' reported intention to change the behavior, and emotions regulation strategies (evaluated at 9 months). A total of 410 patients were included. Significant indirect effects of baseline HRQoL (β = .05, 95% CI [-0.001, 0.111]) and cardiac self-efficacy (β = .105, 95% CI [0.06, 0.16]) on physical activity behavior were found, with anxiety symptoms and emotions regulation strategies as significant mediators. Additionally, the mediation of reported intention in the association between cardiac self-efficacy and physical activity levels was estimated. At the final follow-up, we also found a significant direct association between physical activity behavior and HRQoL (β = .12, p < .01), which was indirectly impacted by baseline HRQoL (β = .006, 95% CI [0.000, 0.017]) and cardiac self-efficacy (β = .012, 95% CI [0.003, 0.027]). This study underlines the significance of addressing stress management, anxiety symptoms reduction, and cardiac self-efficacy enhancement when targeting better cardiovascular health outcomes. Identifying cardiovascular risk profiles based on these findings may benefit future clinical practice and further inform secondary prevention policy guidelines. (PsycInfo Database Record (c) 2024 APA, all rights reserved).

Informing Clinical Practice Guidelines for Children and Youth With Down Syndrome: A Survey of Key Partners.

The purpose of this work was to describe input from key partners to inform the scope and priorities for a clinical practice guideline (CPG) pertaining to physical therapy services provided to children and youth with Down syndrome (DS). A 68-item survey was completed by interventionists and parents (n = 296) of children and youth with DS. The most prevalent physical therapy interventions currently being performed included tummy time, postural control activities, activity-based interventions, and play-based interventions. Key partners agreed on the importance of specific clinical outcomes, needing guidance on frequency and dosage of interventions, common barriers to physical therapy intervention, and needing information for discharge criteria in a future CPG. The results of this survey have given the CPG committee the necessary information to inform the CPG process for children and youth with DS.

A systematic review of clinical practice guidelines and recommendations for the management of pain, sedation, delirium and iatrogenic withdrawal syndrome in pediatric intensive care.

This systematic review aimed to evaluate the quality of clinical practice guidelines (CPGs) and recommendations for managing pain, sedation, delirium, and iatrogenic withdrawal syndrome in pediatric intensive care (PICU). The objectives included evaluating the quality of recommendations, synthesizing recommendations, harmonizing the strength of the recommendation (SoR) and the certainty of evidence (CoE), and assessing the relevance of supporting evidence. A comprehensive search in four electronic databases (Medline, Embase.com, CINAHL and JBI EBP Database), 9 guideline repositories, and 13 professional societies was conducted to identify CPGs published from January 2010 to the end of May 2023 in any language. The quality of CPGs and recommendations was assessed using the AGREE II and AGREE-REX instruments. Thematic analysis was used to synthesize recommendations, and the GRADE SoR and CoE harmonization method was used to interpret the credibility of summary recommendations. A total of 18 CPGs and 170 recommendations were identified. Most CPGs were of medium-quality, and three were classified as high. A total of 30 summary recommendations were synthesized across each condition, focused on common management approaches. There was inconsistency in the SoRs and CoE for summary recommendations, those for assessment showed the highest consistency, the remaining were conditional, inconsistent, inconclusive, and lacked support from evidence. This systematic review provides an overview of the quality of CPGs for these four conditions in the PICU. While three CPGs achieved high-quality ratings, the overall findings reveal gaps in the evidence base of recommendations, patient and family involvement, and resources for implementation. The findings highlight the need for more rigorous and evidence-based approaches in the development and reporting of CPGs to enhance their trustworthiness. Further research is necessary to enhance the quality of recommendations for this setting. The results of this review can provide a valuable foundation for future CPG development. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=274364, PROSPERO (CRD42021274364).

SAT447 Gaps In Care: Endocrine-disrupting Chemicals And Metabolic Disease Management Guidelines

Abstract Disclosure: M. Obeid: None. A. Majid: None. R.M. Sargis: None. In recent decades, global rates of obesity, diabetes, and non-alcoholic fatty liver disease have increased substantially, imposing significant morbidity and mortality on patients and severe economic strain on healthcare systems. Discussions of modifiable risk factors responsible for metabolic dysfunction have classically centered upon the role of excess energy intake and insufficient energy expenditure. Consequently, clinical practice guidelines have largely focused upon these factors when addressing disease risk and treatment. In recent years, however, new metabolic risk factors have emerged, including exposure to endocrine-disrupting chemicals (EDCs). Because exposure to EDCs is potentially modifiable through individual action and/or public policy, we sought to understand how practice guidelines for metabolic disorders have incorporated this new knowledge into clinical care. To accomplish this, we searched PubMed for the years 2007 to 2022 for European, Asian, and American clinical practice guidelines related to obesity, diabetes, non-alcoholic fatty, dyslipidemia, chronic kidney disease, and cardiovascular disease. Each guideline was then searched by two reviewers for 83 terms related to environmental factors linked to metabolic dysfunction. Environment-related statements were then adjudicated by three reviewers for relevance. Select guidelines for non-metabolic disorders linked to environmental factors were similarly reviewed for comparison, including asthma, chronic obstructive pulmonary disease (COPD), and obstetrics/gynecology guidelines. In total, 68 guidelines and statements were systematically reviewed. While environmental risk reduction was partially addressed in COPD, asthma, and cardiovascular guidelines, those focused on obesity, diabetes, and non-alcoholic fatty liver disease did not address the contribution of EDCs or other ambient environmental factors. Across all guidelines only air pollution received substantive attention, leaving other EDCs nearly entirely neglected. A clear but inadequately considered component of the social and structural determinants of health, environmental exposures have emerged as modifiable risk factors for multiple metabolic disorders. While further work is needed, future clinical practice guidelines should incorporate clinical interventions, research initiatives, and policy recommendations to address the impact of poor environments on human metabolic health. Presentation: Saturday, June 17, 2023

The Effects of Complementary Therapies on Patient-Reported Outcomes: An Overview of Recent Systematic Reviews in Oncology.

Many patients with cancer make use of complementary medicine alongside conventional medicine, but clinicians in oncology often lack the knowledge to adequately advise patients on the evidence base for complementary therapies. This study aims to provide an overview of recently published systematic reviews that assess the effects of complementary therapies on patient-reported health outcomes in patients with cancer. Systematic reviews, including a meta-analysis of at least two randomized controlled trials, were identified from the PubMed, Embase, Cochrane Library, CINAHL and PsycINFO databases. The methodological quality was assessed with AMSTAR 2. One hundred systematic reviews were included. The results suggest that several complementary therapies can improve health outcomes reported by patients with cancer, such as acupuncture to relieve pain, music interventions to reduce anxiety and yoga to improve cancer-related fatigue. The side effects related to complementary therapy use are generally mild. The results remain inconclusive for some intervention-outcome combinations. Many of the included systematic reviews insufficiently assessed the causes and impact of bias in their interpretation of the results. This overview of systematic reviews can support clinicians in counselling their patients on this topic and provide directions for future research and clinical practice guidelines in the field of complementary medicine.

Clinical Practice Guideline Recommendations in Pediatric Orthopaedic Injury: A Systematic Review.

Lack of adherence to recommendations on pediatric orthopaedic injury care may be driven by lack of knowledge of clinical practice guidelines (CPGs), heterogeneity in recommendations or concerns about their quality. We aimed to identify CPGs for pediatric orthopaedic injury care, appraise their quality, and synthesize the quality of evidence and the strength of associated recommendations. We searched Medline, Embase, Cochrane CENTRAL, Web of Science and websites of clinical organizations. CPGs including at least one recommendation targeting pediatric orthopaedic injury populations on any diagnostic or therapeutic intervention developed in the last 15 years were eligible. Pairs of reviewers independently extracted data and evaluated CPG quality using the Appraisal of Guidelines Research and Evaluation (AGREE) II tool. We synthesized recommendations from high-quality CPGs using a recommendations matrix based on the GRADE Evidence-to-Decision framework. We included 13 eligible CPGs, of which 7 were rated high quality. Lack of stakeholder involvement and applicability (i.e., implementation strategies) were identified as weaknesses. We extracted 53 recommendations of which 19 were based on moderate or high-quality evidence. We provide a synthesis of recommendations from high-quality CPGs that can be used by clinicians to guide treatment decisions. Future CPGs should aim to use a partnership approach with all key stakeholders and provide strategies to facilitate implementation. This study also highlights the need for more rigorous research on pediatric orthopaedic trauma. Level II-therapeutic study.

Analysis of Conservative Treatment Trends for Lumbar Disc Herniation with Radiculopathy in Korea: A Population-Based Cross-Sectional Study.

This study aimed to analyze the trends in conservative treatment and associated medical costs for lumbar intervertebral disc disorders with radiculopathy in Korea. This population-based cross-sectional study included patients aged ≥ 20 years with at least one "intervertebral disc disorder with radiculopathy" claim (Korean Standard Classification of Diseases (KCD)-7 code: M511) who sought treatment from tertiary, general, or Korean Medicine hospitals or clinics between 2010 and 2019 and whose data were extracted from the Korean Health Insurance Review and Assessment Service National Patients Sample database. Intervention frequency, ratio, and medical costs, including medication, were analyzed. The number of patients with lumbar intervertebral disc disorders and radiculopathy undergoing conservative treatment increased by >30%, and medical costs increased from USD 3,342,907 to USD 5,600,456 during the 10-year period. The non-surgical treatments mainly used were medication and physiotherapy, and the most commonly prescribed medication was non-opioid analgesics. Meanwhile, the number of patients who used nerve plexus and root and ganglion nerve blocks showed the most significant increase. In conclusion, the number of patients with radiculopathy who received nerve blocks, particularly nerve plexus and root and ganglion nerve blocks, and related expenditure increased, implying a gradual shift in medical decisions from systemic pain reduction to specific and targeted pain treatments. Future studies and clinical practice guidelines may require further inspection of real-world practice to advise optimal treatment choices for an effective treatment plan.

Defining ruxolitinib failure and transition to next-line therapy for patients with myelofibrosis: a modified Delphi panel consensus study.

Aim: To define ruxolitinib failure and develop parameters to guide transition to next-line therapy for patients with myelofibrosis. Methods: A modified Delphi panel with 14 hematologists-oncologists. Survey concepts included defining primary refractory status, loss of response, disease progression, intolerance and transition to next-line therapy. Results: Ruxolitinib failure may be defined as no improvement in symptoms or spleen size, progressive disease or ruxolitinib intolerance, following a maximally tolerated dose for ≥3months. Loss of spleen response 1month after initial response may prompt discontinuation. Lack of evidence to inform transition to next-line therapy was noted; tapering ruxolitinib should be considered according to ruxolitinib dose and patient characteristics. Conclusion: Expert consensus was provided on defining ruxolitinib failure and transition to next-line therapy as summarized in this position paper, which may support considerations in the development of future clinical practice guidelines.

Diagnostic and Therapeutic Strategies for Stable Coronary Artery Disease Following the ISCHEMIA Trial.

Until recently, coronary revascularization with coronary artery bypass grafting or percutaneous coronary intervention has been regarded as the standard choice for stable coronary artery disease (CAD), particularly for patients with a significant burden of ischemia. However, in conjunction with remarkable advances in adjunctive medical therapy and a deeper understanding of its long-term prognosis from recent large-scale clinical trials, including ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches), the approach to stable CAD has changed drastically. Although the updated evidence from recent randomized clinical trials will likely modify the recommendations for future clinical practice guidelines, there are still unresolved and unmet issues in Asia, where prevalence and practice patterns are markedly different from those in Western countries. Herein, the authors discuss perspectives on: 1) assessing the diagnostic probability of patients with stable CAD; 2) application of noninvasive imaging tests; 3) initiation and titration of medical therapy; and 4) evolution of revascularization procedures in the modern era.

Effectiveness of an mHealth App as an add-on for Smoking Cessation in One year: A multicenter and randomized Trial (The MASCOT study)

Introduction: Smoking accounts for 480,000 deaths per year in the United States. Traditional pharmacotherapeutic interventions for smoking cessation continue to fail, urging the implementation of new therapies to prevent further harm. Mobile Health apps have appeared to support smoking cessation; their low cost, wide availability, absence of side effects, and drug-to-drug interaction make them useful adjuncts in some populations. Despite promising results, only a small number of smoking cessation apps have been formally researched as an add-on therapy. Therefore, we hypothesize that using a mobile health app (PIVOT) as an add-on to the current standard therapy (varenicline plus cognitive-behavioral therapy) could increase the smoking cessation rate. Methods: We propose a Phase III, multicenter, randomized, parallel-group, open-label, superiority trial. The control group will receive varenicline 1mg/daily for 3 months plus 10 sessions of cognitive-behavioral therapies. The intervention group will receive the same treatment plus the addition of the PIVOT® app for one year. Participants will be 21 to 60 years old who meet the Tobacco Use Disorder criteria. The primary outcome will be smoking abstinence at 1 year of follow-up. Secondary outcomes will be lapses and relapses, cotinine hair drug testing at the end of follow-up, and the impact on Quality of Life measured through the WHO Quality of Life Scale-Brief questionnaire.&nbsp; Discussion: mobile Health Apps are widely available and extensively used by smokers to aid smoking cessation; however, their effectiveness as an add-on is unproven. This study will provide evidence on this matter to advise future clinical practice guidelines and decrease the morbidity and mortality attributable to tobacco use.

Exploring the lived experience of renal cachexia for individuals with end-stage renal disease and the interrelated experience of their carers: Study protocol.

Renal cachexia is an important consideration in the person-centred care that is needed in end-stage renal disease (ESRD). However, given that clinical guidelines relating to renal cachexia are largely absent, this is an unmet care need. To inform guidelines and future renal service planning, there is an urgency to understand individuals' experiences of renal cachexia and the interrelated experiences of the carers in their lives. We report here the protocol for an interpretative phenomenological study which will explore this lived experience. A purposive sampling strategy will recruit individuals living with ESRD who have cachexia and their carers. A maximum of 30 participants (15 per group) dependent on saturation will be recruited across two nephrology directorates, within two healthcare trusts in the United Kingdom. Individuals with renal cachexia undergoing haemodialysis will be recruited via clinical gatekeepers and their carers will subsequently be invited to participate in the study. Participants will be offered the opportunity to have a face-to-face, virtual or telephone interview. Interviews will be audio-recorded, transcribed verbatim and analysed using interpretative phenomenological analysis. NVivo, will be used for data management. Ethical approval for this study was granted by the Office for Research Ethics Committees Northern Ireland (REC Reference: 22/NI/0107). Scientific evidence tends to focus on measurable psychological, social and quality of life outcomes but there is limited research providing in-depth meaning and understanding of the views of individuals with renal disease who are experiencing renal cachexia. This information is urgently needed to better prepare healthcare providers and in turn support individuals with ESRD and their carers. This study will help healthcare providers understand what challenges individuals with ESRD, and their carers face in relation to cachexia and aims to inform future clinical practice guidelines and develop supportive interventions which recognise and respond to the needs of this population.