The MOHIP-14PW (Modified Oral Health Impact Profile 14-Item Version for Pregnant Women): A Real-World Study of Its Psychometric Properties and Relationship with Patient-Reported Oral Health.

Background: The 14-item version of the Oral Health Impact Profile (OHIP-14) has been widely used as a measure for oral health-related quality of life (OHQoL) since its publication in 1997. However, few studies have examined its psychometric properties and relationship with patient-reported oral health in pregnant women. Aim: To offer empirical evidence for appropriate use of the OHIP-14 among pregnant women in research and clinical practice. Objectives: (1) to empirically investigate the psychometric properties of the OHIP-14, (2) to modify it into the MOHIP-14PW (modified OHIP-14 for pregnant women), and (3) to compare their relationships with patient-reported oral health in pregnant women. Methods: In this real-world study (RWS) from suburban New York clinics, we collected OHIP-14 data from 291 pregnant women and assessed its psychometric properties at the item-, dimension-, and measure-level, including confirmatory factor analysis (CFA) and exploratory factor analysis (EFA). Accordingly, we modified the OHIP-14 into the MOHIP-14PW. Finally, we compared their correlations with patient-reported oral health scores. Results: All OHIP-14 items had severely skewed distributions, and two had a correlation with the patient-reported oral health < 0.1. All seven pairs of items correlated well (0.47 to 0.62), but the Cronbach's alphas indicated suboptimal reliability, with two below 0.70. CFA results offered suboptimal support to the original structure, and EFA found a three-dimensional structure best fitted the data. Therefore, we modified the OHIP-14 into the MOHIP-14PW. CFA on the MOHIP-14PW offered stronger supports, and the Cronbach's alphas increased to 0.92, 0.72, and 0.71. The MOHIP-14PW's dimensions were more meaningful to pregnant women and had stronger relationships with patient-reported oral health than the OHIP-14; the average correlation coefficients increased by 26% from 0.19 in OHIP-14 to 0.24 in the MOHIP-14PW. Conclusions: The original OHIP-14 required modifications at the item-, dimension-, and measure- level, and the MOHIP-14PW had better psychometric properties, easier interpretation, and stronger correlation with patient-reported oral health in low-income pregnant women. Through an interdisciplinary RWS on a large sample of pregnant women, this study offers concrete empirical evidence for the advantages of the MOHIP-14PW over the original OHIP-14.

Efficacy assessment for low-level laser therapy in the treatment of androgenetic alopecia: a real-world study on 1383 patients.

Low-level laser therapy (LLLT) has been a treatment modality by many androgenetic alopecia (AGA) patients in recent years. It remained unclear as to how long the treatment regime should be maintained, and which characteristics of patients should this be recommended. A real-world study was carried out with an FDA-cleared low-level laser helmet for 1383 patients. Ordinal logistic regression analysis with propensity score matching (PSM) was used to investigate the factors related to efficacy assessment. More than 80% of users were between 18 and 40 years old. The median use times were 133 for mild AGA patients and 142 for moderate-to-severe AGA patients, which equated to 38 weeks and 40 weeks, respectively. The overall clinical effectiveness was nearly 80%. PSM analysis revealed that gender (P = 0.002), use period (P = 0.068), scalp conditions with dandruff, rash, and itchy symptoms were associated with the grading of efficacy assessment. Male users (ordinal OR: 1.35, CI: (1.01, 1.79)); use for more than 180 times or use period for 1 year (ordinal OR: 1.40, CI: (1.11, 1.96)); and those with scalp dandruff (ordinal OR: 1.34, CI: (1.01, 1.87)), rash (ordinal OR: 1.47, CI: (1.04, 2.07)), and itchy symptoms (ordinal OR: 1.51, CI: (1.12, 2.03)) had better efficacy assessments. The recommended treatment regime with low-level laser helmet was more than 1 year or 180 use times. Male patients with dandruff, rash, and itchy symptoms in scalps tended to have a better efficacy assessment.

[Application of real world study and human use experience in research and development of new traditional Chinese medicine drugs].

Real world study(RWS) refers to the process of collecting real world data related to the health of research subjects in the real world environment for pre-set clinical problems and obtaining the status of drug use and potential benefits/risks through analysis. The data are derived from the hospital information system(HIS), medical insurance system, disease registration system, adverse drug reaction monitoring system, etc. Human use experience of traditional Chinese medicine(TCM) is a new concept put forward by experts after summarizing the problems existing in clinical trials of new TCM drugs. The data come partially from the real world, and more importantly, such key elements as the formulated prescriptions of new TCM drugs, principles and methods, and clinical applications should be covered. RWS is mainly used for adverse drug reaction monitoring after marketing, benefit evaluation of listed drugs, decision-making of medical treatment and medical insurance, as well as supervision and approval of special medical devices and special drugs. It is complementary to randomized controlled clinical trials. Human use experience is suitable for the research and development of Chinese medicinal compound preparations and the expansion of functions and indications. There are no special provisions for clinical indications and target population. There exists a sequential relationship between the human use experience and clinical trials. Specifi-cally, the summarization of human use experience provides good support for the design and implementation of clinical trials, which is an important segment in the research and development of new TCM drugs. The correlation between real-world data and research results and their reliability should be ensured in RWS, and the unreality should be avoided. The key to summarizing the human use experience is to identify the clinical orientation, target population, course of treatment, usage and dosage of new TCM drugs, and it should be noted that human use experience does not only mean clinical experience. Experimental clinical trial(PCT), a type of study in the real world, has been commonly employed for the summary of human use experience. RWS and human use experience are different research designs targeting different clinical questions in the research and development of new TCM drugs, which can be flexibly selected depending on the actual situation.

Hepatic Resection Versus Transarterial Chemoembolization for Intermediate-Stage Hepatocellular Carcinoma: A Cohort Study.

BACKGROUND: The selection criteria for hepatic resection (HR) in intermediate-stage (IM) hepatocellular carcinoma (HCC) are still controversial. We used real-world data to evaluate the overall survival (OS) in treatment with HR or transarterial chemoembolization (TACE). METHODS: In total, 942 patients with IM-HCC were categorized into the HR group and the TACE group. OS was analyzed using the Kaplan-Meier method, log-rank test, Cox proportional hazards models, and propensity score-matched (PSM) analysis. Curve smoothing was performed through the generalized additive model. The interaction test was performed to evaluate the impact of HR on OS concerning risk factors. Also, we used multiple imputation to deal with missing data. RESULTS: In total, 23.0% (n = 225) of patients received HR. At a median OS of 23.7 months, HR was associated with improved OS in the multivariate analysis [hazard ratio (HzR) = 0.45, 95%CI = 0.35-0.58; after PSM: HzR = 0.56, 95%CI = 0.41-0.77]. Landmark analyses limited to long-term survivors of ≥6 months, ≥1 year, and ≥2 years demonstrated better OS with HR in all subsets (all p < 0.05). After PSM analysis, however, HR increased the risk of death by 20% (HzR = 1.20, 95%CI = 0.67-2.15) in the subgroup of patients with lactate dehydrogenase (LDH) ≤192 U/L (p for interaction = 0.037). Furthermore, the significant interaction was robust between the LDH and HR with respect to the 1-, 3-, and 5-year observed survival rates (all p < 0.05). CONCLUSION: HR was superior to TACE for intermediate-stage HCC in patients with LDH levels >192 U/L. Moreover, TACE might be suitable for patients with LDH levels ≤192 U/L.

Application of real world study and human use experience in research and development of new traditional Chinese medicine drugs / 中国中药杂志

Real world study(RWS) refers to the process of collecting real world data related to the health of research subjects in the real world environment for pre-set clinical problems and obtaining the status of drug use and potential benefits/risks through analysis. The data are derived from the hospital information system(HIS), medical insurance system, disease registration system, adverse drug reaction monitoring system, etc. Human use experience of traditional Chinese medicine(TCM) is a new concept put forward by experts after summarizing the problems existing in clinical trials of new TCM drugs. The data come partially from the real world, and more importantly, such key elements as the formulated prescriptions of new TCM drugs, principles and methods, and clinical applications should be covered. RWS is mainly used for adverse drug reaction monitoring after marketing, benefit evaluation of listed drugs, decision-making of medical treatment and medical insurance, as well as supervision and approval of special medical devices and special drugs. It is complementary to randomized controlled clinical trials. Human use experience is suitable for the research and development of Chinese medicinal compound preparations and the expansion of functions and indications. There are no special provisions for clinical indications and target population. There exists a sequential relationship between the human use experience and clinical trials. Specifi-cally, the summarization of human use experience provides good support for the design and implementation of clinical trials, which is an important segment in the research and development of new TCM drugs. The correlation between real-world data and research results and their reliability should be ensured in RWS, and the unreality should be avoided. The key to summarizing the human use experience is to identify the clinical orientation, target population, course of treatment, usage and dosage of new TCM drugs, and it should be noted that human use experience does not only mean clinical experience. Experimental clinical trial(PCT), a type of study in the real world, has been commonly employed for the summary of human use experience. RWS and human use experience are different research designs targeting different clinical questions in the research and development of new TCM drugs, which can be flexibly selected depending on the actual situation.

Immune checkpoint inhibitors for non-small cell lung cancer: Research progress of real-world studies / 中国肿瘤临床

Several immune checkpoint inhibitors (ICIs) have been approved for use in patients with advanced non-small cell lung cancer (NSCLC) based on the results of randomized controlled trials (RCTs), bringing new hope to patients with such disease. However, the applicability of the RCT results is limited due to their strict inclusion criteria and specific clinical settings. Real-world studies (RWS) can integrate data from real-life practice with long-term clinical observations and follow-up, therefore building up the real-world evidence to complement that provided by conventional clinical trials. ICIs have been used in clinical practice in multiple countries and areas for several years. Here, we aim to provide an overview of the efficacy and safety of ICIs in patients with NSCLC included in the large expanded access program and multicenter retrospective observational studies and review the impact of different populations to provide a reference for ICIs use in China.