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

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*

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

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*

PURPOSE: Upfront systemic chemotherapy with target agents has been recommended for patients with stage IV colon cancer. Some with partial response are considered for curative resection. There is high risk of developing postoperative complications following upfront systemic chemotherapy. We aimed to evaluate short-term perioperative outcomes of curative surgery after upfront chemotherapy in comparison with upfront surgery in patients with metastatic colon cancer.METHODS: Between January 2010 and October 2015, 146 patients (80 in the surgery first group, 66 in the upfront chemotherapy group) who underwent surgical resection before or after systemic chemotherapy for metastatic colon cancer were included in the present study. All decisions for treatment were made through a multidisciplinary team. Postoperative clinical outcomes and complications were analyzed to compare the groups.RESULTS: There was no difference between the 2 groups in terms of postoperative clinical outcomes. Overall complication rates were not different between the groups (surgery first group: 46.3% vs. upfront chemotherapy group: 60.6%; P = 0.084). When classified according to the Clavien-Dindo method, there was no difference between the 2 groups in terms of major complications (grade 3 or more) (surgery first group: 18.9% vs. upfront chemotherapy group: 27.5%; P = 0.374).CONCLUSION: There was no significant increase in major postoperative complications in metastatic colon cancer patients who received upfront chemotherapy followed by curative surgery. Careful patient selection and treatment planning are important.
Antineoplastic Agents ; Colon ; Colonic Neoplasms ; Drug Therapy ; Humans ; Methods ; Neoplasm Metastasis ; Patient Selection ; Postoperative Complications

There has been controversy regarding the first-line treatment modality for the patients who have small solitary hepatocellular carcinoma (HCC); radiofrequency ablation (RFA) or percutaneous ethanol injection (PEI), surgical hepatic resection (HR) and liver transplantation (LT). For selection of treatment modality of HCC, it should be considered of hepatic reservoir function as well as the tumor stage. If the liver function is good enough, HR may be the first choice regardless of the tumor size. However, recent studies comparing RFA with resection showed comparable outcome and similar survival rates. RFA, HR and LT provide good outcome for patients who have small HCCs. RFA would be desired in patients who have below 3.0 cm in size and low alpha-fetoprotein (<200 ng/mL). However, in small HCC with high tumor marker, HR should be considered. Better patient selection for the ‘resection first’ approach and early detection of recurrence can achieve better outcomes of the salvage LT strategy. Another benefit of resection first strategy is that it make possible to do enlist of LT for patients before recurrence at high risk of HCC recurrence after resection on the basis of pathologic aggressiveness, microvascular invasion and/or satellites nodule. They should be applied appropriately according to the tumor size, location, tumor markers and underlying liver parenchymal disease.
alpha-Fetoproteins ; Biomarkers, Tumor ; Carcinoma, Hepatocellular ; Catheter Ablation ; Ethanol ; Hepatectomy ; Humans ; Liver ; Liver Transplantation ; Patient Selection ; Recurrence ; Survival Rate

BACKGROUND AND OBJECTIVE: Since the introduction of hospital pharmacy residency programs in 1983, hospital pharmacists in South Korea have been expected to expand their roles. However, their services and the outcomes have not been fully understood. In this study, we conducted a systematic review of Korean hospital pharmacist-provided interventions with regard to intervention type, intervention consequences, and target patient groups. METHODS: A literature search of the following databases was performed: Embase, PubMed, Medline, KoreaMed, RISS, KMbase, KISS, NDSL, and KISTI. The search words were “hospital pharmacist”, “clinical pharmacist”, and “Korea”. Articles reporting clinical or economic outcome measures that resulted from hospital pharmacist interventions were considered. Numeric measures for the acceptance rate of pharmacist recommendations were subjected to meta-analysis. RESULTS: Of the 1,683 articles searched, 44 met the inclusion selection criteria. Most articles were published after 2000 (81.8%) and focused on clinical outcomes. Economic outcomes had been published since 2011. The interventions were classified as patient education, multidisciplinary team work, medication assessment, and guideline development. The outcome measures were physicians’ prescription changes, clinical outcomes, patient adherence, economic outcomes, and quality of life. The acceptance rate was 80.5% (p < 0.005). CONCLUSION: Studies on pharmacist interventions have increased and showed increased patient health benefits and reduced medical costs at Korean hospital sites. Because pharmacists' professional competency would be recognized if the economic outcomes of their work were confirmed and justified, studies on their clinical performance should also include their economic impact.
Humans ; Insurance Benefits ; Korea ; Outcome Assessment (Health Care) ; Patient Compliance ; Patient Education as Topic ; Patient Selection ; Pharmacists ; Pharmacy Residencies ; Prescriptions ; Quality of Life