High-quality Clinical Research Research Articles

Children's Acute Cough-Specific Quality of Life: Revalidation and Development of a Short Form.

Acute cough in children has a significant impact on the child and family. Relevant quality of life (QoL) instruments are essential for high-quality clinical research. This study aimed to (1) revalidate the 16-item Parent-proxy Children's Acute Cough-specific QoL questionnaire (PAC-QoL16) using a different dataset (i.e., different children), (2) confirm the minimally important difference (MID), and (3) develop and validate a short form. Three datasets from two sources were utilized, comprising of 332 children with acute cough (< 2weeks duration); the first dataset (n = 83, 54 boys; median age 2.04years, IQR 1.08-4.06years) was used for revalidation, the second dataset (n = 238, 141 boys; median age 2.17years, IQR 1.21-4.21years) was used to develop the short form, and the third dataset (n = 94, 62 boys; median age, 1.75years, IQR 0.90-3.63years) was used to confirm the short form. Psychometric properties were investigated. Six items were found to account for 96.4% of the variance in the PAC-QoL16. The PAC-QoL16 and short form (PAC-QoL6) scales correlated with cough scores (rs ≤ -0.40, p < 0.001), were internally consistent (Cronbach α = 0.94 and 0.87, respectively) and demonstrated sensitivity to change over time. A MID of 0.71 to 1.11 is recommended. Both the PAC-QoL16 and newly developed short form (PAC-QoL6) are reliable and valid outcome measures that assess children's acute cough-specific QoL at a given time point, are easy to interpret and reflect changes over time. The new short form addresses the need for outcome measures to be as time effective as possible without loss of information.

Building research capacity in India: The Masters in Clinical Research program at the Tata Memorial Centre.

Clinical research is an essential part of evidence-based medicine. The conduct of high-quality clinical research requires the backing of strong infrastructure, especially well-trained clinical research professionals. Tata Memorial Centre is the largest public cancer center in India and has been offering a Masters degree in Clinical Research since 2014. In this article, we look at the need for clinical research training, the evolution of this course and the impact it has had on clinical research capacity in India

Overview of systematic evaluation of efficacy of Tongxie Yaofang in treating diarrhea-predominant irritable bowel syndrome.

Tongxie Yaofang is commonly used in the treatment of IBS-D. Many systematic reviews have confirmed its efficacy and safety, but the methodology and quality of evidence need to be further evaluated. The databases of Chinese National Knowledge Infrastructure (CNKI), Chinese Biomedical Literature (CBM), Wanfang, VIP, Web of Science (SCI), PubMed, Cochrane Library, and Embase were searched to gather systematic evaluations of TXYF in treating IBS-D. The search time was from inception to January 2021. The search was performed independently by 2 researchers who screened the literature and extracted data. Methodological quality of the studies included in the systematic evaluation was evaluated by the A MeaSurement Tool to Assess systematic Reviews-2 (AMSTAR-2) scale. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system was used to categorize the evidence quality of outcome indicators, and the curative effect evaluation was summarized. A total of 10 systematic evaluations were included, and the results of AMSTAR-2 evaluation showed that 6 reports were relatively complete, 4 reports were poor, and the overall quality was not high. It was revealed that TXYF can improve the total clinical effective rate and symptoms of patients with IBS-D, but the GRADE evaluation results showed that the quality of evidence was low to extremely low. It is suggested that further high-quality clinical research should be conducted to provide more reliable evidence-based medical evidence for the application of TXYF in the treatment of irritable bowel syndrome.

A review of psycho-physiological pathological mechanisms and clinical treatments of functional somatic symptoms

<p indent=0mm>As a common clinical problem, functional somatic symptom (FSS) causes significant distress and functional damage to patients, and brings pressure to doctors and the medical system. It challenges the traditional Cartesian mind-body dualism. In light of recent advancements in neuroscience and interdisciplinary findings in FSS, we review the mechanisms of FSS in a central-peripheral order and summarize the current evidence-based treatments of FSS in a clinical process fashion. We provide the following suggestions concerning future research in China: (1) strengthen the continuing education of psychosomatic training for doctors of all medical specialties; (2) carry out high-quality clinical intervention research on FSS; (3) and carry out interdisciplinary and translational research on FSS.

Fluid management in patients undergoing neurosurgery

Fluid management is an important component of perioperative care for patients undergoing neurosurgery. The primary goal of fluid management in neurosurgery is the maintenance of normovolemia and prevention of serum osmolarity reduction. To maintain normovolemia, it is important to administer fluids in appropriate amounts following appropriate methods, and to prevent a decrease in serum osmolarity, the choice of fluid is essential. There is considerable debate about the choice and optimal amounts of fluids administered in the perioperative period. However, there is little high-quality clinical research on fluid therapy for patients undergoing neurosurgery. This review will discuss the choice and optimal amounts of fluids in neurosurgical patients based on the literature, recent issues, and perioperative fluid management practices.

Efficacy and safety of Suxiao Jiuxin Pill in the treatment of stable angina (Qi stagnation and blood stasis syndrome): study protocol of a randomized, double-blind, placebo-controlled, multi-center clinical trial

BackgroundCoronary heart disease (CHD) has become one of the biggest health problems in the world. Stable angina is a common clinical type of CHD with poor prognosis and high mortality. Although there are various interventions for stable angina, none of them can significantly reduce mortality. Both basic and clinical research have shown that Suxiao Jiuxin Pill (SJP) can relieve the symptoms of angina pectoris and improve the clinical efficacy, but there is a lack of high-quality clinical research to provide research-based evidence. We design a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of SJP for stable angina.Methods/designThis is a prospective, randomized, double-blind, placebo-controlled, and multicenter trial. The trial will enroll 324 participants with chronic stable angina (Qi Stagnation and Blood Stasis syndrome). All participants will have received the conventional therapy of chronic stable angina. Participants will be randomized into two groups, conventional therapy plus SJP group and conventional therapy plus placebo group. Eligible participants will receive either SJP or placebo (five pills administered orally, three times daily) in addition to conventional treatment for 24 weeks. The primary outcomes are the symptom improvement rate of angina from baseline to 4 weeks after inclusion and major adverse cardiovascular events (MACE). The secondary outcomes are angina classification (CCS), improvement of traditional Chinese medicine (TCM) syndromes, Seattle Angina Scale score, the dosage of emergency drugs and the stopping rate, and electrocardiogram (EKG) efficacy. Adverse events will be monitored throughout the trial.DiscussionIntegrated traditional Chinese and Western Medicine is commonly used for angina in China. This study will evaluate the clinical effectiveness and safety of SJP for angina. The results of the trial will provide high-level clinical research-based evidence for the application of SJP instable angina.Trial registrationThis study protocol was registered on 14 March 2019. The registration number is ChiCTR1900021876 on the Chinese Clinical Trial Registry.

The Society of Thoracic Surgeons General Thoracic Surgery Database: 2021 Update on Outcomes and Research

The Society of Thoracic Surgeons General Thoracic Surgery Database (STS GTSD) remains the largest and most robust thoracic surgical database in the world. Participating sites receive risk-adjusted performance reports for benchmarking and quality improvement initiatives. The GTSD also provides several mechanisms for high-quality clinical research using data from 271 participant sites and nearly 720,000 procedures since its inception in 2002. Participant sites are audited at random annually for completeness and accuracy. During the last year and a half, the GTSD Task Force continued to refine the data collection form, ensuring high-quality data while minimizing data entry burden. In addition, the STS Workforce on National Databases has supported robust GTSD-based research program, which led to 10 scholarly publications in 2020. This report provides an update on outcomes, volume trends, and database improvements as well as a summary of research productivity resulting from the GTSD over the preceding year.

Strengthening capacity for clinical research in sub-Saharan Africa: partnerships and networks

Global research collaboration, through partnerships and networks, is an effective way to deliver highly impactful and sustainable research that is collectively owned and promoted for the global good. Many models exist for effective North-South collaborations that are built on trust and balanced benefits. The European & Developing Countries Clinical Trials Partnership (EDCTP) model emphasises capacity development in clinical trials and product-focused implementation research. To ensure effectiveness and sustainability, capacity development requires a long-term perspective, an integrated system-wide approach, and local ownership and leadership from countries experiencing high disease burdens. Guided by these principles, the EDCTP2 programme, established in 2014, has developed and strengthened human capital and institutional capacities in 39 countries in sub-Saharan Africa to undertake high-quality clinical research guided by good clinical and regulatory practices. Projects in these countries have involved 238 African and 163 European institutions. To date, EDCTP has supported 171 Fellows and 232 postgraduate trainees. EDCTP-short-term training activities have equipped 9628 researchers and medical personnel. The EDCTP capacity-building described here includes its Regional Networks of Excellence and its Consortia for public health emergencies which provide the foundation for sustained efforts against emerging and re-emerging global health threats.

Perioperative Management of Von Willebrand Disease: An Institutional Experience

Introduction: Von Willebrand disease (VWD) is the most common inherited bleeding disorder affecting as many as 1% of the population. Mucocutaneous symptoms predominate, and include ecchymosis, menorrhagia, and epistaxis. In addition, perioperative bleeding is common, and often prompts diagnosis; therefore, affected patients require perioperative VWD-specific therapy to prevent surgical related bleeding. VWF-specific therapy includes DDAVP, intravenous and nasal, and VWF concentrates, plasma derived, and more recently, recombinant. Unfortunately, few standard evidence-based guidelines are in place concerning the perioperative management of VWD, in part due to a limited number of high quality clinical research studies addressing the topic. Because of this, treatments vary widely, often based on local practice and physician experience. To evaluate the efficacy and safety of perioperative VWD-specific therapy, we aimed to describe our experience managing VWD patients undergoing surgery. Methods: We performed a retrospective chart review of patients with VWD receiving care at the Hemophilia Center of Western Pennsylvania (HCWP) who underwent surgery at a University of Pittsburgh Medical Center (UPMC) affiliated hospital between January 1, 2015, and May 31, 2017. Surgery was defined as any invasive procedure, including childbirth. Data collected included demographics; VWD subtype; VWD-specific therapy, including type, dose, frequency, and duration; estimate blood loss during surgery; presence of postoperative bleeding; and whether or not thrombosis occurred. Results: A total of64 patients with VWD receiving care at HCWP underwent surgery at an UPMC-affiliated hospital during the time period. The mean age of participants was 32.9 ± 17.5 years (median 33, range 2 to 89). Of these, 86% of patients were female. By type, 80% were type 1 VWD; 17% were type 2 VWD (2A, n=1; 2B, n=5; 2M, n=3; and 2N, n=2); and 2 were type 3 VWD (Table 1). The most common surgeries performed included vaginal delivery, n=7; cesarean section, n=6; dental extraction, n=4; colonoscopy with biopsy, n=3; and breast biopsy, n=3 (Table 1). 83% of patients received VWF concentrates, and the remaining patients received DDAVP (Table 1). Reasons for VWF concentrate use included DDAVP allergy, poor response to DDAVP, type of VWD, and type of surgery. Dosing, frequency, and duration of VWD-specific therapy differed considerably. Estimated blood loss (EBL), intraoperatively, was minimal (defined as less than 100 mL) in all but 12 surgeries, 11 of which involved childbirth with EBL 1000 mL or less in all. The other surgery was a dental extraction of 23 teeth with EBL 270 mL. Postoperative bleeding occurred in 3 patients, and included minor epistaxis following adenoidectomy and minor oral mucosa bleeding following a single dental extraction. 1 patient experienced a large breast hematoma following bilateral breast reduction requiring operative evacuation. No thromboses occurred. Discussion: We describe the perioperative management of 64 patients with VWD at our institution. VWD-specific therapy was both safe and effective, evidenced by minimal bleeding and no adverse events. A large number of patients were pregnant. It is our practice to utilize VWF concentrates in most pregnant VWD patients during childbirth due to the risk of DDAVP induced fluid retention and hyponatremia in the peripartum period. Our findings are indicative of its efficacy and safety in this particular situation. Despite these findings, there were considerable differences in dosing, frequency, and duration of VWD-specific therapy. This parallels the known variation in treatment of VWD among practitioners, in large part, due to the lack of evidence-based guidelines available to help standardize therapy. In conclusion, we describe the safe and effective perioperative management of VWD while acknowledging differences in treatment, which further underscores the need for high quality clinical research studies and evidence-based guidelines to standardize the perioperative management of VWD. Download : Download high-res image (308KB) Download : Download full-size image Disclosures Ragni: Alnylam, CSL Behring, Dimensions, Genetech/Roche,Pfizer, Shire, SPARK: Research Funding; A Anylam,Biomarin,Tecere, Benitec: Honoraria.

The model of care at a leading medical cannabis clinic in Canada

Medical cannabis access has been legalized in more than 30 countries worldwide and popularity among patients is increasing rapidly. Cannabinoid-based treatments have been shown to be beneficial for several symptoms such as chemotherapy-induced nausea and vomiting, spasticity, chronic pain, intractable seizures and insomnia, yet high-quality clinical trials are still limited. As millions of patients now have legal access to medical cannabis, little information is available about the development of best clinical practices and an effective medical cannabis clinic model.A medical cannabis clinic is an innovative and emergent practice model that may be necessary to bridge the gap between patient and healthcare provider interest and existing barriers to the prescription of medical cannabis treatments, such as limited medical education, lack of high-quality clinical research and challenging or evolving regulatory frameworks. In this paper, we describe the model of care and organization of a dedicated medical cannabis clinic operating in Quebec, Canada since 2014. We share the principles of medical cannabis practice, including the structure of its medical and support team, clinic organisation and procedure guidelines. Key clinic statistics and patient demographics are shared with year by year comparison.Operating since 2014, the clinic has endured a rapidly changing regulatory landscape in Canada, overcoming numerous challenges including medical and social stigma, limited funding, resources and institutional support combined with a high demand for services. To support medical cannabis leaders globally, an important knowledge-sharing is required. The clinic has expanded to a network of four clinic sites across Quebec and offers continuing education and preceptorships to health care providers and trainees as well as research services to both academic and industry partners. The description of the clinic offers guidance on medical cannabis treatment and care and discusses possible solutions to associated challenges. The clinic model of care can be adapted to different healthcare settings and regulatory frameworks; it may assist physicians and health care providers in the development of medical cannabis clinics or the implementation of best practices as medical cannabis access continues to evolve.

Immune Axonal Neuropathies Associated With Systemic Autoimmune Rheumatic Diseases.

Immune axonal neuropathies are a particular group of immune-mediated neuropathies that occasionally accompany systemic autoimmune rheumatic diseases such as connective tissue dissorders and primary systemic vasculitides. Apart from vasculitis of vasa nervorum, various other mechanisms are involved in their pathogenesis, with possible therapeutic implications. Immune axonal neuropathies have highly heterogeneous clinical presentation and course, ranging from mild chronic distal sensorimotor polyneuropathy to severe subacute mononeuritis multiplex with rapid progression and constitutional symptoms such as fever, malaise, weight loss and night sweats, underpinning a vasculitic process. Sensory neuronopathy (ganglionopathy), small fiber neuropathy (sensory and/or autonomic), axonal variants of Guillain-Barré syndrome and cranial neuropathies have also been reported. In contrast to demyelinating neuropathies, immune axonal neuropathies show absent or reduced nerve amplitudes with normal latencies and conduction velocities on nerve conduction studies. Diagnosis and initiation of treatment are often delayed, leading to accumulating disability. Considering the lack of validated diagnostic criteria and evidence-based treatment protocols for immune axonal neuropathies, this review offers a comprehensive perspective on etiopathogenesis, clinical and paraclinical findings as well as therapy guidance for assisting the clinician in approaching these patients. High quality clinical research is required in order to provide indications and follow up rules for treatment in immune axonal neuropathies related to systemic autoimmune rheumatic diseases.

Looking forward to the future direction of colorectal surgery in the perspective of clinical research and data collection

Colorectal surgery has been developed rapidly in China because of the advance of minimally invasive surgical techniques, perioperative comprehensive treatment strategies and clinical research in recent years. Comparing the current diagnosis and treatment of colorectal cancer between China and western industrialized countries, it can be found that the specialized construction and standardized diagnosis and treatment of colorectal surgery in western industrialized countries are very mature, and the multidisciplinary diagnosis and treatment model of colorectal cancer has been standardized. Although there is almost no difference between high-level colorectal cancer centers in the eastern coastal areas of China and western countries, due to the vast size and uneven regional development of China, standardized surgery and standardized treatment concepts of colorectal surgery still need to be popularized. Combined with the current diagnosis and treatment of colorectal cancer in China, more high-quality clinical research should be carried out to seek new development and breakthroughs in the field of colorectal surgery. Combined with the experience of international and domestic clinical research that has been participated in or carried out, the author believes that quality control of clinical research should be carried out from the following two points: 1. structured training and quality control of research; 2. establishment and management of databases. In a word, we should not only focus on colon surgery itself, but also complete the transformation to research-oriented doctors and research-oriented disciplines, cultivate the concept of data collection and clinical research, enhance the scientific awareness of clinical research, and integrate high-quality data collection and clinical research into daily clinical practice. Only in this way can we fundamentally improve the comprehensive strength of China's colorectal surgery, effectively carry out surgical-related clinical research based on the current situation colorectal diseases in China, and obtain high-level evidence-based medical evidence based on the research results of the population of patients in China, and form a guide for the diagnosis and treatment of colorectal surgery in China, which will also guide the clinical practice of patients with colorectal diseases in China. This will certainly be a new direction for the development of Chinese colorectal surgery.

Methadone and Ketamine: Boosting Benefits and Still More to Learn.

Methadone and Ketamine: Boosting Benefits and Still More to Learn.

Consensus exercise identifying priorities for research in the field of general surgery of childhood in the UK.

BackgroundThe evidence base underlying clinical practice in children’s general surgery is poor and high-quality collaborative clinical research is required to address current treatment uncertainties. The aim of this study was, through a consensus process, to identify research priorities for clinical research in this field amongst surgeons who treat children.MethodsQuestions were invited in a scoping survey amongst general surgeons and specialist paediatric surgeons. These were refined by the study team and subsequently prioritized in a two-stage modified Delphi process.ResultsIn the scoping survey, a total of 226 questions covering a broad scope of children’s elective and emergency general surgery were submitted by 76 different clinicians. These were refined to 71 research questions for prioritization. A total of 168 clinicians took part in stage one of the prioritization process, and 157 in stage two. A ‘top 10’ list of priority research questions was generated for both elective and emergency general surgery of childhood. These cover a range of conditions and concepts, including inguinal hernia, undescended testis, appendicitis, abdominal trauma and enhanced recovery pathways.ConclusionThrough consensus amongst surgeons who treat children, 10 priority research questions for each of the elective and emergency fields have been identified. These should provide a basis for the development of high-quality multicentre research projects to address these questions, and ultimately improve outcomes for children requiring surgical care.

Anesthesiology and Critical Care Response to COVID-19 in Resource-Limited Settings: Experiences from Nepal.

It is difficult to predict the future course and length of the ongoing COVID-19 pandemic, which has devastated health care systems in low- and middle-income countries. Anesthesiology and critical care services are hard hit because many hospitals have stopped performing elective surgeries, staff and scarce hospital resources have been diverted to manage COVID-19 patients, and several makeshift COVID-19 units had to be set up. Intensive care units are overwhelmed with critically ill patients. In these difficult times, low- and middle-income countries need to improvise, perform indigenous research, adapt international guidelines to suit local needs, and target attainable clinical goals.

Ultraviolet Induced Skin Inflammation

Abstract Ultraviolet (UV) induced skin inflammation (UISI) is associated with many skin disorders. However, the mechanism by which UV causes skin inflammation remains unclear. Studies evaluating UISI in vivo have mainly been conducted using mouse models. Current investigations indicate that the classic inflammatory pathways involving nuclear factor kappa B and Toll-like receptor contribute to the regulation of UISI. However, more novel signaling factors have been identified as being involved in this process, including interleukin 22 receptor-α, cluster of differentiation 28 and cluster of differentiation 1d, serum amyloid A1, estrogen, melatonin, peroxisome proliferator activated receptors β/δ, isocitrate dehydrogenase 2, and transglutaminase 2. In addition, the gene mutation of fermitin family member 1 and selenium deficiency are reported to affect the phenotype of UISI. Although the actual roles of UISI in UV-related skin diseases need to be clarified, recent studies have reported the potent contribution of UISI to photocarcinogesis. To clarify the process and modulation of UISI, the special profiles of cytokines and inflammatory mediators and the core regulatory pathways should be identified clearly. These investigations would be promoted rapidly, accompanied by the conduction of high-quality clinical research on patients with UV-related skin disease and the construction of precise animal models of UISI.

The Effectiveness and Safety of Cinobufotalin Injection as an Adjunctive Treatment for Lung Cancer: A Meta-Analysis of Randomized Controlled Trials.

Cinobufotalin injection is a water-soluble preparation extracted from the skin secretion of Bufo bufo gargarizans Cantor or B. melanotictus Schneider, which has been widely used as an adjuvant treatment in lung cancer patients. This study aimed to evaluate the clinical efficacy and safety of cinobufotalin (PubChem CID: 259776) injection as an adjunctive treatment for lung cancer. We designed a meta-analysis that performed following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. We aim to include randomized controlled trials by systematically searching the PubMed, EMBASE, CNKI, Wanfang database, VIP, CBM, the Cochrane Central Register of Controlled Trials, and Chinese Clinical Trial Registry from inception to Mar 1, 2020, comparing the difference between the use of cinobufotalin injection as an adjunctive treatment and a control group without cinobufotalin injection. The objective response rate (ORR) and quality of life (QOL) will be defined as the primary outcomes, and the disease control rate (DCR) and adverse events will be defined as the secondary outcomes. We included 21 articles with 1735 cases of lung cancer patients. Comparison results show that combining with cinobufotalin injection can improve ORR (OR = 1.77, 95% CI [1.43, 2.21], P < 0.001), with low heterogeneity (P = 0.94, I2 = 0%); DCR (OR = 2.20, 95% CI [1.70, 2.85], P < 0.001), with low heterogeneity (P = 0.60, I2 = 0%); KPS score (OR = 3.10, 95% CI [2.23, 4.32], P < 0.001), with low heterogeneity (P = 0.85, I2 = 0%); and the effect of pain relief (OR = 2.68, 95% CI [1.30, 5.55], P = 0.008), with low heterogeneity (P = 0.72, I2 = 0%). Low-to-moderate evidence shows that cinobufotalin injection combined with chemotherapy can significantly increase ORR, DCR, QOL, and the effect of pain relief. Meanwhile, cinobufotalin injection did not bring additional adverse events such as hematological toxicity, gastrointestinal toxicity, cardiotoxicity, hepatotoxicity, and nephrotoxicity; however, multicenter, large-sample, high-quality clinical research results are still needed to reveal the therapeutic effect of cinobufotalin injection in small-cell lung cancer (PROSPERO registration number: CRD42020170052).

Research progression in clinical treatment of gastric cancer in 2020

Gastric cancer is a common type of malignant tumors, but its clinical prognosis remains unsatisfactory. Up to 2020, a growing number of high-quality clinical researches has provided reliable evidence for clinical practice. Evidences from surgery, perioperative treatment and immunotherapy, such as changes in surgical methods, improvement of perioperative chemotherapy and combination of immune and chemotherapy strategy, provided the possibility to improve the clinical efficacy of gastric cancer. In our clinical practice, gastrointestinal surgeons need to integrate the current research progression and develop individualized strategy for different patients, which is expected to further improve the prognosis and quality of life for patients with gastric cancer.

Gender Affirming Surgery: A Comprehensive, Systematic Review of All Peer-reviewed Literature and Methods of Assessing Patient-centered Outcomes (Part 1: Breast/Chest, Face, and Voice).

To perform the first systematic review of all available gender-affirming surgery (GAS) publications across all procedures to assess both outcomes reported in the literature and the methods used for outcome assessment. Rapidly increasing clinical volumes of gender-affirming surgeries have stimulated a growing need for high-quality clinical research. Although some procedures have been performed for decades, each individual procedure has limited data, necessitating synthesis of the entire literature to understand current knowledge and guide future research. A systematic review was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines to identify all outcomes measures in GAS cohorts, including PCOs, complications, and functional outcomes. Outcome data were pooled to assess currently reported complication, satisfaction, and other outcome rates. Overall, 15,186 references were identified, 4162 papers advanced to abstract review, and 1826 underwent full-text review. After review, there were 406 GAS cohort publications. Of non-genitoplasty titles, 35 were mastectomy, 6 mammoplasty, 21 facial feminization, and 31 voice/cartilage. Although 59.1% of non-genitoplasty papers addressed PCOs in some form, only 4.3% used instruments partially-validated in transgender patients. Overall, data were reported heterogeneously and were biased towards high-volume centers. This study represents the most comprehensive review of GAS literature. By aggregating all previously utilized measurement instruments, this study offers a foundation for discussions about current methodologic limitations and what dimensions must be included in assessing surgical success. We have assembled a comprehensive list of outcome instruments; this offers an ideal starting basis for emerging discussions between patients and providers about deficiencies which new, better instruments and metrics must address. The lack of consistent use of the same outcome measures and validated GAS-specific instruments represent the 2 primary barriers to high-quality research where improvement efforts should be focused.

Integrating Academic and Community Cancer Care and Research through Multidisciplinary Oncology Pathways for Value-Based Care: A Review and the City of Hope Experience.

As the US transitions from volume- to value-based cancer care, many cancer centers and community groups have joined to share resources to deliver measurable, high-quality cancer care and clinical research with the associated high patient satisfaction, provider satisfaction, and practice health at optimal costs that are the hallmarks of value-based care. Multidisciplinary oncology care pathways are essential components of value-based care and their payment metrics. Oncology pathways are evidence-based, standardized but personalizable care plans to guide cancer care. Pathways have been developed and studied for the major medical, surgical, radiation, and supportive oncology disciplines to support decision-making, streamline care, and optimize outcomes. Implementing multidisciplinary oncology pathways can facilitate comprehensive care plans for each cancer patient throughout their cancer journey and across large multisite delivery systems. Outcomes from the delivered pathway-based care can then be evaluated against individual and population benchmarks. The complexity of adoption, implementation, and assessment of multidisciplinary oncology pathways, however, presents many challenges. We review the development and components of value-based cancer care and detail City of Hope’s (COH) academic and community-team-based approaches for implementing multidisciplinary pathways. We also describe supportive components with available results towards enterprise-wide value-based care delivery.