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

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*

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

Oral squamous cell carcinoma (OSCC) is the most common oral malignancy and an increasing global public health problem. OSCC frequently invades the jaw bone. OSCC-induced bone invasion has a significant impact on tumor stage, treatment selection, patient outcome, and quality of life. A number of studies have shown that osteoclast-mediated bone resorption is a major step in the progression of bone invasion by OSCC; however, the molecular mechanisms involved in OSCC bone invasion are not yet clear. In this review, we present the clinical types of OSCC bone invasion and summarize the role of key molecules, including proteases, cytokines, and growth factors, in the sequential process of bone invasion. A better understanding of bone invasion will facilitate the discovery of molecular targets for early detection and treatment of OSCC bone invasion.
Bone Resorption ; Carcinoma, Squamous Cell ; Cytokines ; Epithelial Cells ; Intercellular Signaling Peptides and Proteins ; Jaw ; Patient Selection ; Peptide Hydrolases ; Public Health ; Quality of Life

BACKGROUND/AIMS: Ustekinumab is effective in active Crohn's disease. In a retrospective study, we assessed the clinical outcome in nonresponders to anti-tumor necrosis factor therapy, and/or conventional therapy and/or the α4β7-integrin inhibitor vedolizumab. As approval study populations do not always reflect the average “real world” patient cohort, we assessed weather patients who would not have qualified for approval studies show similar outcomes. METHODS: Forty-one patients with mild to severe active Crohn's disease were treated with ustekinumab (intravenous 6 mg per kg/body weight) followed by subcutaneous ustekinumab (90 mg) at week 8. Depending on the clinical response maintenance therapy was chosen every 8 or 12 weeks. Clinical response was defined by Crohn's Disease Activity Index (CDAI) decline, decline of stool frequency or clinical improvement. Inclusion criteria for approval studies were assessed. RESULTS: The 58.5% (24/41) showed clinical response to ustekinumab. The 58.3% of this group (14/24) achieved clinical remission. Clinical response correlated significantly with drop of stool frequency and improvement of CDAI score. The 39 out of 41 patients had no side effects and we observed no serious infections. About a third of our patients would not have met ustekinumab approval study criteria. However, patients who did not meet study criteria showed clinical improvement numerically in the same range compared to patients who would have qualified for approval studies. CONCLUSIONS: Ustekinumab is effective, safe and well tolerated in a highly therapy refractory patient cohort. Even though a reasonable number of patients did not meet ustekinumab approval study criteria, approval study results seem to be representative to the overall patient cohort.
Biological Therapy ; Cohort Studies ; Crohn Disease ; Humans ; Necrosis ; Patient Selection ; Retrospective Studies ; Ustekinumab ; Weather

PURPOSE: Poor physiological reserve for withstanding major cancer surgery in older adults is an important concern in the selection of patients for oncologic gastrectomy. The present study aimed to analyze mortality patterns among patients who underwent gastrectomy for cancer according to age groups. The primary outcomes of this study were early- and middle-term results: 30-day and 3-, 6-, 12-, and 36-month mortality rates. MATERIALS AND METHODS: A retrospective review of 288 patients who underwent surgical resection for gastric cancer in two centers was carried out. Patients were stratified into four groups according to age: 29–50 years (group I, n=27), 51–65 years (group II, n=117), 66–75 years (group III, n=81), and 76–92 years (group IV, n=58). Statistical calculations focused on the differences in the survival rates between groups I and II as well as between groups II and IV. RESULTS: The middle-aged patients (group II) had significantly better 3-year survival than either the youngest (group I) or the oldest patients (group IV). The 6-month mortality rates were 16.9% in group III and 29.3% in group IV. Two-thirds of the patients from groups III and IV who died between 2 and 6 months after surgery had an uneventful postoperative course. CONCLUSIONS: Age is an important prognostic factor of middle-term survival after gastrectomy for cancer. Geriatric assessment and better patient selection for major surgery for cancer are required to improve the outcome of gastrectomy for cancer in patients aged over 75 years.
Adult ; Gastrectomy ; Geriatric Assessment ; Geriatrics ; Humans ; Mortality ; Patient Selection ; Retrospective Studies ; Stomach Neoplasms ; Survival Rate