Randomized controlled trial(RCT) is considered to represent the gold standard for evaluating the efficacy of interventions and has been widely used to evaluate the clinical efficacy of traditional Chinese medicine(TCM). However, there are unique challenges in implementing RCT in TCM. Patients seeking TCM treatment often have preferences for TCM due to the unsatisfactory therapeutic effect of western medicine, their personal intolerance, and their rejection of certain drugs, medical devices, or surgery. Patients are generally reluctant to be randomly assigned to a group, making it challenging to enroll patients in the control group of western medicine during the implementation of RCT in TCM. This has become a prominent problem restricting the implementation of RCT in TCM and needs to be solved urgently. Therefore, this paper introduced commonly used research designs used in solving the problem of enrolling patients in control group during the implementation of RCT in TCM, including Zelen design, partially randomized patient preference trial(PRPP), single-arm objective performance criteria(OPC), cohort studies, single-arm clinical trials using real world data(RWD) alone as the external control group, and the design method based on RWD-augmented control group samples in RCT. The paper outlined the definitions and principles of these methods, evaluated their advantages, disadvantages, and applicable scenarios, and explored their applications in the TCM field, so as to offer insights for solving the difficulty in enrolling patients in the control group during the implementation of RCT in TCM.
Humans ; Medicine, Chinese Traditional/methods* ; Randomized Controlled Trials as Topic/methods* ; Research Design ; Patient Selection ; Drugs, Chinese Herbal/therapeutic use* ; Control Groups

Colpotomy ; Disease-Free Survival ; Gynecology ; Humans ; Hysterectomy ; Magnetic Resonance Imaging ; Minimally Invasive Surgical Procedures ; Obstetrics ; Patient Selection ; Recurrence ; Uterine Cervical Neoplasms

patient recruitment, we surveyed whether the hospitals were using 2-mSv CT in usual practice.RESULTS: The analyses included responses from 579 participants (203 attendings and 376 trainees; 221 radiologists, 196 emergency physicians, and 162 surgeons). Regarding the willingness to immediately change their standard practice to 2-mSv CT, 158 (27.3%), 375 (64.8%), and 46 (7.9%) participants responded as “yes” (consistently), “partly” (selectively), and “no”, respectively. Willingness varied considerably across the hospitals, but only slightly across the participants' departments or job titles. Willingness was significantly associated with attendings (p = 0.004), intention to maintain the dedicated appendiceal CT protocol (p < 0.001), belief in compelling evidence on the carcinogenic risk of conventional-dose CT radiation (p = 0.028), and hospitals having more than 1000 beds (p = 0.031). Fourteen of the 20 hospitals kept using 2-mSv appendiceal CT in usual practice after the trial.CONCLUSION: Despite the extensive efforts over the years of this clinical trial, many care providers were willing to use 2-mSv CT selectively or not willing to use.]]>
Adolescent ; Appendicitis ; Emergencies ; Humans ; Intention ; Logistic Models ; Patient Selection ; Pragmatic Clinical Trial ; Prospective Studies ; Radiation Dosage ; Surgeons ; Surveys and Questionnaires ; Young Adult

Immune checkpoint inhibitors (ICIs) have shown remarkable benefit in the treatment of patients with non-small-cell lung cancer (NSCLC) and have emerged as an effective treatment option even in the first-line setting. ICIs can block inhibitory pathways that restrain the immune response against cancer, restoring and sustaining antitumor immunity. Currently, there are 4 PD-1/PD-L1 blocking agents available in clinics, and immunotherapy-based regimen alone or in combination with chemotherapy is now preferred option. Combination trials assessing combination of ICIs with chemotherapy, targeted therapy and other immunotherapy are ongoing. Controversies remain regarding the use of ICIs in targetable oncogene-addicted subpopulations, but their initial treatment recommendations remained unchanged, with specific tyrosine kinase inhibitors as the choice. For the majority of patients without targetable driver oncogenes, deciding between therapeutic options can be difficult due to lack of direct cross-comparison studies. There are continuous efforts to find predictive biomarkers to find those who respond better to ICIs. PD-L1 protein expressions by immunohistochemistry and tumor mutational burden have emerged as most well-validated biomarkers in multiple clinical trials. However, there still is a need to improve patient selection, and to establish the most effective concurrent or sequential combination therapies in different NSCLC clinical settings. In this review, we will introduce currently used ICIs in NSCLC and analyze most recent trials, and finally discuss how, when and for whom ICIs can be used to provide promising avenues for lung cancer treatment.
Biomarkers ; Carcinoma, Non-Small-Cell Lung ; Drug Therapy ; Humans ; Immunohistochemistry ; Immunotherapy ; Lung Neoplasms ; Oncogenes ; Patient Selection ; Protein-Tyrosine Kinases

Allergy and Immunology ; Ambulatory Care ; Autoimmune Diseases/therapy* ; COVID-19 ; Communicable Disease Control ; Connective Tissue Diseases/therapy* ; Delivery of Health Care/methods* ; Dermatology ; Humans ; Immunosuppressive Agents/therapeutic use* ; Patient Selection ; SARS-CoV-2 ; Singapore ; Skin Diseases, Vesiculobullous/therapy* ; Telemedicine/methods* ; Tertiary Care Centers ; Vasculitis/therapy*

Penile prosthesis implantation is the gold standard of surgical therapy for patients with medication-refractory erectile dysfunction. However, this umbrella definition includes significant heterogeneity and associated risk profiles that should be candidly discussed and addressed perioperatively. Factors associated with operative success and patient satisfaction are often surgery specific; however, risk profiling via patient selection, preoperative optimization, proper device selection, and intraoperative consideration are highly correlated. Some examples of common risk profiles include comorbidity(ies) such as cardiovascular disease, diabetes mellitus, prior abdominal surgery, Peyronie's disease, and psychological risk factors. Similarly, integration of surgeon- and patient-amenable characteristics is key to decreasing risk of infection, complication, and need for revision. Finally, patient risk profiling provides a unique context for proper device selection and evidence-based intraoperative considerations.
Cardiovascular Diseases/epidemiology* ; Comorbidity ; Diabetes Mellitus/epidemiology* ; Erectile Dysfunction/surgery* ; Humans ; Male ; Mental Disorders/epidemiology* ; Patient Satisfaction ; Patient Selection ; Penile Implantation/methods* ; Penile Induration/epidemiology* ; Penile Prosthesis ; Postoperative Complications/prevention & control* ; Prosthesis-Related Infections/prevention & control* ; Reoperation ; Risk Assessment ; Surgical Wound Infection/prevention & control*

The testicular prosthesis can be an afterthought for providers when performing an orchiectomy for testicular cancer, torsion, atrophic testis, or trauma. However, data suggest that patients find the offer of a testicular prosthesis and counseling regarding placement to be extremely important from both a pragmatic and a psychosocial perspective. Only two-thirds of men undergoing orchiectomy are offered an implant at the time of orchiectomy and of those offered about one-third move forward with prosthesis placement. The relatively low acceptance rate is in stark contrast with high patient satisfaction and low complication rates for those who undergo the procedure. The most common postoperative patient concerns are minor and involve implant positioning, size, and weight. Herein, we provide an up-to-date review of modern preoperative evaluation, patient selection, expectation management, surgical technique, and expected outcomes for testicular prostheses.
Counseling ; Gonadal Dysgenesis, 46,XY/surgery* ; Humans ; Male ; Orchiectomy ; Patient Satisfaction ; Patient Selection ; Postoperative Complications/epidemiology* ; Prosthesis Implantation/methods* ; Spermatic Cord Torsion/surgery* ; Testicular Diseases/surgery* ; Testicular Neoplasms/surgery* ; Testis/surgery* ; Urologic Surgical Procedures, Male/methods*

OBJECTIVES: Jeju Province is well known as the region showing the highest incidence of severe fever with thrombocytopenia syndrome (SFTS) in South Korea. The aim of this study was to evaluate the epidemiological and clinical characteristics of SFTS patients in Jeju Province. METHODS: The primary data for this study were obtained from the Integrated Diseases and Health Control System of the Korea Centers for Disease Control and Prevention (KCDCIS). The selection criteria were confirmed cases of SFTS with a residence listed in Jeju Province at the time of diagnosis, reported to the KCDCIS between July 16, 2014 and November 30, 2018. RESULTS: Of 55 confirmed cases of SFTS, the case fatality rate was 10.9% (95% confidence interval [CI], 4.1 to 22.2). The most common presenting symptoms at diagnosis of severe fever, myalgia, and diarrhea had incidences of 83.6% (95% Cl, 71.2 to 92.2), 45.5% (95% Cl, 32.0 to 59.5), and 40.0% (95% CI, 27.0 to 54.1), respectively. CONCLUSIONS: Compared to SFTS patients nationwide in 2013-2015, the subjects of this study exhibited a lower case fatality rate and had a lower incidence of severe fever, myalgia, and confusion.
Bunyaviridae Infections ; Centers for Disease Control and Prevention (U.S.) ; Diagnosis ; Diarrhea ; Fever ; Humans ; Incidence ; Korea ; Mortality ; Myalgia ; Patient Selection ; Thrombocytopenia ; Tick-Borne Diseases

OBJECTIVE: Neuroimaging in headache patients identifies clinically significant neurological abnormalities and plays an important role in excluding secondary headache diagnoses. We performed a systematic review and meta-analysis of the existing guidelines and studies surrounding neuroimaging in headache patients. METHODS: The research question involved determining the prevalence of detecting clinically significant neurological abnormalities using neuroimaging in patients suspected of primary headache. Searches of the PubMed and Embase databases were conducted on English-language studies published from 1991 to 2016, and the reference lists of the retrieved articles were also checked manually. All headache subtypes and patients aged ≥15 years were included in the analysis. RESULTS: Ten studies met the selection criteria. The pooled prevalence of detecting clinically significant abnormalities in the neuroimaging of headache patients was 8.86% (95% confidence interval: 5.12–15.33%). Subsequently, diverse subgroup analyses were performed based on the detection method, headache type, study type, study region, age group, and disease type. CONCLUSION: The present findings indicate that limited neuroimaging methods should be carefully considered for headache diagnostic purposes when there are red flag symptoms. Limitations and suggested directions for future studies on neuroimaging in headache patients are described.
Diagnosis ; Headache ; Humans ; Magnetic Resonance Imaging ; Methods ; Neuroimaging ; Patient Selection ; Prevalence ; Tomography, X-Ray Computed

Long-standing persistent atrial fibrillation (L-PeAF) is a category in which rhythm control is attempted while atrial fibrillation (AF) is maintained for more than 1 year. Because AF is a progressive disease and L-PeAF accompanies significant electrical and structural remodeling of atria, it is difficult to restore and maintain sinus rhythm in patients with L-PeAF. Nonetheless, the rhythm outcome is being increasingly improved by the development of sophisticated mapping devices, highly efficient catheters, and evidence-based ablation strategies, and the rational choice of patient selection criteria. This review discusses the evolution of the rhythm control outcome of L-PeAF and its future direction of development.
Atrial Fibrillation ; Catheter Ablation ; Catheters ; Humans ; Patient Selection ; Pulmonary Veins