Patient-reported Outcomes (PROs): An Approach to Evaluate Treatment Efficacy of Chinese Medicine or Integrative Medicine

Chinese medicine (CM) has been an experience based practice over the past three thousand years. The safety and efficacy of CM has been practised through experience, rather than nowadays’ modern scientific measurements. In this way, the development of CM has not been keeping pace with the advance in science and technology and the progress in orthodox medicine. In order to meet the requirements of modern science and technology, an evidence based approach must be adopted. Reassurance is needed to convince people for safety and efficacy of CM and give confidence to the evidence based demands ——“Tradition is confirmed by Modern Science” (1) .

Voices that matter:The impact of patient-reported outcome measures on clinical decision-making

The critical role of patient-reported outcome measures(PROMs)in enhancing clinical decision-making and promoting patient-centered care has gained a profound significance in scientific research.PROMs encapsulate a patient's health status directly from their perspective,encompassing various domains such as symptom severity,functional status,and overall quality of life.By integrating PROMs into routine clinical practice and research,healthcare providers can achieve a more nuanced understanding of patient experiences and tailor treatments accordingly.The deployment of PROMs supports dynamic patient-provider interactions,fostering better patient engagement and adherence to tre-atment plans.Moreover,PROMs are pivotal in clinical settings for monitoring disease progression and treatment efficacy,particularly in chronic and mental health conditions.However,challenges in implementing PROMs include data collection and management,integration into existing health systems,and acceptance by patients and providers.Overcoming these barriers necessitates technological advancements,policy development,and continuous education to enhance the acceptability and effectiveness of PROMs.The paper concludes with recommendations for future research and policy-making aimed at optimizing the use and impact of PROMs across healthcare settings.

Patient-Reported Outcomes in Prostate Cancer: Prospective Changes Analysis for Prognosis Prediction

Prostate cancer is affecting a higher proportion of male population. Health Related Quality of Life assessment can guide the development of an interdisciplinary and patient-centered care intervention. This study is aimed to assess Health Related Quality of Life in prostate cancer patients. Relationships between socio-demographic, clinical characteristics and patient-reported outcomes have been considered. Consecutive outpatients with prostate cancer, admitted at the Urology Clinic of the Instituto Português de Oncologia do Porto, were studied (n = 300). Health Related Quality of Life was assessed as part of the routine practice. The European Organisation for Research and Treatment of Cancer general questionnaire, QLQ-C30, and its specific module for prostate cancer patients, QLQ-PR25, were used. Evolution along time (elapsed since diagnosis, and up to 5 years) was considered in order to search for a prognosis prediction in prostate cancer patients. This study confirms the feasibility of a systematic Health Related Quality of Life assessment. Global Health Related Quality of Life was found to be higher 6 months after diagnosis, decreasing then until the second year after diagnosis and improving thereafter. A peak with better scores was identified at the fifth year after diagnosis. Social and physical dimensions revealed a similar pattern. Clinical significance was found 6 months and 5 years after diagnosis. The prospective analysis of Health Related Quality of Life changes is able to explore the patients’ outcomes in order to find patterns and relationships for prognosis prediction along the disease course. Such approach might promote patient confidence and thus a better cancer experience.

Insulin therapy in type 2 diabetes: Insights into clinical efficacy, patient-reported outcomes, and adherence challenges

Insulin therapy plays a crucial role in the management of type 2 diabetes as the disease progresses.Over the past century,insulin formulations have undergone significant modifications and bioengineering,resulting in a diverse range of available insulin products.These products show distinct pharmacokinetic and pharmacodynamic profiles.Consequently,various insulin regimens have em-erged for the management of type 2 diabetes,including premixed formulations and combinations of basal and bolus insulins.The utilization of different insulin regimens yields disparate clinical outcomes,adverse events,and,notably,patient-reported outcomes(PROs).PROs provide valuable insights from the patient’s perspective,serving as a valuable mine of information for enhancing healthcare and informing clinical decisions.Adherence to insulin therapy,a critical patient-reported outcome,significantly affects clinical outcomes and is influenced by multiple factors.This review provides insights into the clinical effectiveness of various insulin preparations,PROs,and factors impacting insulin therapy adherence,with the aim of enhancing healthcare practices and informing clinical decisions for individuals with type 2 diabetes.

Clinical study inpatient-reported outcomes after binocular implantation of aspheric intraocular lens of different negative spherical aberrations

Objective: To compare patient-reported outcomes after implantation of the ZA9003 intraocular lens(IOLs), or the MCX11 ASP IOLs or the spherical IOLs(HQ-201HEP). Methods: Prospective nonrandomized controlled trial was used. A total of 105 patients(210 eyes) were divided into three groups according to the type of IOLs: ZA9003(35 patients, 70 eyes), MCX11 ASP(35 patients, 70 eyes) or HQ-201HEP(35 patients, 70 eyes). The main outcome was scores of Catquest nine-item short-form questionnaire. Additional outcome was best corrected visual acuities, spherical aberration(SA) and total higher-order aberrations(HOAs). Results: The global score was significantly lower in the spherical IOL group than the aspherical IOL group of-020 μm SA(P < 0.05) and the aspherical IOL group of-027 μm SA(P < 0.05), and no significant difference was found in the global score between the aspherical IOL group of-020 μm SA than the aspherical IOL group of-027 μm SA(P > 0.05). Significant differences were also found in question 2, question 5, question 6 and question 8 between the spherical IOLs and the aspherical IOLs. Conclusion: Implantation of an aspherical IOL could improve vision-related quality of life compared with a spherical IOL. However, there were no statistically significant differences in vision-related quality of life between aspheric IOLs with different negative spherical aberrations.

Establishing minimum clinically important difference values for the Patient-Reported Outcomes Measurement Information System Physical Function, hip disability and osteoarthritis outcome score for joint reconstruction, and knee injury and osteoarthritis out

AIM To establish minimum clinically important difference(MCID) for measurements in an orthopaedic patient population with joint disorders.METHODS Adult patients aged 18 years and older seeking care for joint conditions at an orthopaedic clinic took the Patient-Reported Outcomes Measurement Information System Physical Function(PROMIS~? PF) computerized adaptive test(CAT), hip disability and osteoarthritis outcome score for joint reconstruction(HOOS JR), and the knee injury and osteoarthritis outcome score for joint reconstruction(KOOS JR) from February 2014 to April 2017. MCIDs were calculated using anchorbased and distribution-based methods. Patient reports of meaningful change in function since their first clinic encounter were used as an anchor.RESULTS There were 2226 patients who participated with a mean age of 61.16(SD = 12.84) years, 41.6% male, and 89.7% Caucasian. Mean change ranged from 7.29 to 8.41 for the PROMIS~? PF CAT, from 14.81 to 19.68 for the HOOS JR, and from 14.51 to 18.85 for the KOOS JR. ROC cut-offs ranged from 1.97-8.18 for the PF CAT, 6.33-43.36 for the HOOS JR, and 2.21-8.16 for the KOOS JR. Distribution-based methods estimated MCID values ranging from 2.45 to 21.55 for the PROMIS~? PF CAT; from 3.90 to 43.61 for the HOOS JR, and from 3.98 to 40.67 for the KOOS JR. The median MCID value in the range was similar to the mean change score for each measure and was 7.9 for the PF CAT, 18.0 for the HOOS JR, and 15.1 for the KOOS JR.CONCLUSION This is the first comprehensive study providing a wide range of MCIDs for the PROMIS? PF, HOOS JR, and KOOS JR in orthopaedic patients with joint ailments.

Patient-Reported Outcomes of Surgery of Non-Small Cell Lung Cancer: Evaluation Based on the Questionnaires of Anti-Aging Quality of Life and the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire

Background: Patient-reported outcomes of the quality of life (QOL) after an open thoracotomy have not been studied. To determine the physical and mental changes in surgical patients is very important for medical staffs. The surgical patient’s satisfaction and overall healthy changes were evaluated by the patient-self assessment questionnaires. Materials and Methods: From July 2007 to April 2008, 26 patients with non-small cell lung cancer (NSCLC) underwent surgical resection. The outcome of the QOL was evaluated by using two kinds of questionnaire surveys from the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and the anti-aging QOL assessment (AA-QOL). The EORTC QLQ-C30 consisted of five domains (physical, role, cognitive, emotional, and social functionings) and global QOL. The AA-QOL contained 51 items;30 physical and 21 mental symptoms regarding the elderly and the aging population. The patients replied to the two questionnaires at two different times, i.e., at pre-surgery (baseline) and at post-surgery (2 weeks after the operation). The obtained data of these scores were averaged and compared between the two points of the pre-surgery and post-surgery. Results: Regarding the outcomes of the EORTC QLQ-C30, the physical and social functioning became significantly worse after the surgery. In contrast, the global QOL significantly became better after the surgery. For the symptom at post-surgery, three of which were “nausea and vomiting”, “pain”, and “appetite loss”, became significantly worse compared to those at pre-surgery. Regarding the outcomes of the AA-QOL, the physical symptoms (muscular pain/stiffness, palpitations, dyspnea, no feeling of good health, anorexia, and coughing and sputum) became significantly worse after the surgery. Regarding the mental symptoms, there were no significant differences. Conclusions: Regarding the outcomes based on the changes in the QOL after surgery, the physical symptoms became worse compared to the mental symptoms. To clarify the perioperative healthy changes of the QOL reported by patients with lung cancers is very important for multidisciplinary teamwork, which should play a role in providing the appropriate care and treatment and useful information for a preoperative patient’s decision making of receiving surgical treatment.

Patient-Reported Outcomes of Chemotherapy Involving Non-Small Cell Lung Cancer: Evaluation by Questionnaires of Quality of Life Regarding Anti-Aging and Anti-Cancer Drugs

Background: Patient-reported outcomes (PROs) of quality of life (QOL) during chemotherapy involving lung cancer are very important for the medical staffs. Patients’ satisfaction and healthy changes were evaluated by the patient-self assessment. Materials and Methods: From July 2007 to April 2008, a total of 19 patients received chemotherapy. The QOL data were collected by using the QOL questionnaire for cancer patients treated with anticancer drugs (QOL-ACD) and the anti-aging QOL assessment (AA-QOL). The AA-QOL contained 51 items: 30 of physical and 21 of mental symptoms of the elderly and the aging population. The patients replied to the questions at two different times, i.e., at pre-chemotherapy (baseline) and at post-chemotherapy (2 weeks after the chemotherapy). Results: Regarding the hematological toxicities, for the grade 3/4 toxicities, there were 12 neutropenia (12/19, 63.2%) and 3 thrombocytopenia (3/19, 15.8%). For the grade 3 febrile neutropenia, there were 5 cases (5/19, 26.3%). Regarding the non-hematological toxicities, there was no grade 3 and grade 4 toxicities. Based on the outcomes of the QOL-ACD, the three items (“physical condition”, “social attitude”, and “overall QOL”) at post-chemotherapy became significantly worse compared to the baseline. Regarding the outcomes of the AA-QOL, 4 items of physical symptoms (“thirst”, “anorexia”, “early satiety”, and “diarrhea”) became significantly worse compared to the baseline. Regarding the mental symptoms, 2 items (“nothing to look forward in life” and “a sense of uselessness”) became significantly worse compared to the baseline. Conclusion: Regarding the PROs of the QOL during the chemotherapy term, both the physical and mental symptoms had become worse. To clarify the changes in the QOL during chemotherapy is very important for multidisciplinary teamwork, which should play the role of providing the appropriate cares and treatment as patient-support.

Research Application of Patient-Reported Outcomes in Assessing the Nutritional Status of Patients with Gastrointestinal Tumors

Objective:To investigate and analyze the changes of nutritional status in patients undergoing postoperative adjuvant chemotherapy for gastrointestinal tumors based on patient-reported outcomes.Methods:From July 2020 to March 2021,60 patients with gastrointestinal tumor who received adjuvant chemotherapy for the first time after surgery under the oncology department of a third-level,first-class hospital in Shaanxi Province were recruited by convenience sampling.The patient-reported nutritional evaluation outcomes within 24 hours after admission and during the fourth chemotherapy cycle incorporated nutritional risk screening 2002(NRS2002),Functional Assessment of Anorexia/Cachexia Therapy(FAACT),psychological pain screening,Generalized Anxiety Disorder Assessment(GAD-7),Patient Health Questionnaire-9(PHQ-9)to screen for depression,dietary self-assessment,health index scale(EQ-5D),and nutrition supervisor overall assessment scale.Results:The self-reported nutritional evaluation outcomes by adjuvant chemotherapy patients showed an upward trend along with their chemotherapy cycle.Their PG-SGA score,FAACT score,psychological pain score,and EQ-5D score during the fourth cycle were better than those during the first chemotherapy cycle(p<0.05)・Conclusion:Based on the patient・reported nutritional evaluation outcomes,the nutritional status and quality of life of patients with gastrointestinal tumors during chemotherapy did not worsen.Medical staff should timely evaluate the nutritional status of patients with gastrointestinal tumors during chemotherapy and implement reasonable nutritional intervention to improve the quality of life of patients.In the future,patient-reported outcomes should be considered for integration into clinical practice in order to facilitate patient participation in decision-making and improve their medical experience.

Unveiling hidden outcomes in malignant gastric outlet obstruction research–insights from a"Pancreas 2000"review

Malignant gastric outlet obstruction(mGOO)is a major condition affecting patients with periampullary tumors,including pancreatic cancer.The current treatment options include surgical gastroenterostomy,endoscopic stenting and more recently EUS-guided gastroenterostomy.Most studies comparing the outcomes of the three procedures focus on technical success,clinical success and safety.Several“occult”outcomes relevant to the patient’s viewpoints and perspective may ultimately impact on cancer-related and overall survival,such as body mass composition,nutritional biomarkers,chemotherapy tolerance and patient-reported quality of life.The aim of this review is to provide an overview of potential key outcomes that should be explored in future comparative research around mGOO treatment options.

Mid-term outcomes of a kinematically designed cruciate retaining total knee arthroplasty

BACKGROUND Advances in implant material and design have allowed for improvements in total knee arthroplasty(TKA)outcomes.A cruciate retaining(CR)TKA provides the least constraint of TKA designs by preserving the native posterior cruciate ligament.Limited research exists that has examined clinical outcomes or patient reported outcome measures(PROMs)of a large cohort of patients undergoing a CR TKA utilizing a kinematically designed implant.It was hypothesized that the studied CR Knee System would demonstrate favorable outcomes and a clinically significant improvement in pain and functional scores.AIM To assess both short-term and mid-term clinical outcomes and PROMs of a novel CR TKA design.METHODS A retrospective,multi-surgeon study identified 255 knees undergoing a TKA utilizing a kinematically designed CR Knee System(JOURNEY™II CR;Smith and Nephew,Inc.,Memphis,TN)at an urban,academic medical institution between March 2015 and July 2021 with a minimum of two-years of clinical follow-up with an orthopedic surgeon.Patient demographics,surgical information,clinical outcomes,and PROMs data were collected via query of electronic medical records.The PROMs collected in the present study included the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement(KOOS JR)and Patient-Reported Outcomes Measurement Information System(PROMIS■)scores.The significance of improvements in mean PROM scores from preoperative scores to scores collected at six months and two-years postoperatively was analyzed using Independent Samples t-tests.RESULTS Of the 255 patients,65.5%were female,43.8%were White,and patients had an average age of 60.6 years.Primary osteoarthritis(96.9%)was the most common primary diagnosis.The mean surgical time was 105.3 minutes and mean length of stay was 2.1 d with most patients discharged home(92.5%).There were 18 emergency department(ED)visits within 90 d of surgery resulting in a 90 d ED visit rate of 7.1%,including a 2.4%orthopedic-related ED visit rate and a 4.7%non-orthopedic-related ED visit rate.There were three(1.2%)hospital readmissions within 90 d postoperatively.With a mean time to latest follow-up of 3.3 years,four patients(1.6%)required revision,two for arthrofibrosis,one for aseptic femoral loosening,and one for peri-prosthetic joint infection.There were significant improvements in KOOS JR,PROMIS Pain Intensity,PROMIS Pain Interference,PROMIS Mobility,and PROMIS Physical Health from preoperative scores to six month and two-year postoperative scores.CONCLUSION The evaluated implant is an effective,novel design offering excellent outcomes and low complication rates.At a mean follow up of 3.3 years,four patients required revisions,three aseptic and one septic,resulting in an overall implant survival rate of 98.4%and an aseptic survival rate of 98.8%.The results of our study demonstrate the utility of this kinematically designed implant in the setting of primary TKA.

Variations in quantifying patient reported outcome measures to estimate treatment effect

In the practice of healthcare,patient-reported outcomes(PROs)and PRO measures(PROMs)are used as an attempt to observe the changes in complex clinical situations.They guide us in making decisions based on the evidence regarding patient care by recording the change in outcomes for a particular treatment to a given condition and finally to understand whether a patient will benefit from a particular treatment and to quantify the treatment effect.For any PROM to be usable in health care,we need it to be reliable,encapsulating the points of interest with the potential to detect any real change.Using structured outcome measures routinely in clinical practice helps the physician to understand the functional limitation of a patient that would otherwise not be clear in an office interview,and this allows the physician and patient to have a meaningful conver-sation as well as a customized plan for each patient.Having mentioned the rationale and the benefits of PROMs,understanding the quantification process is crucial before embarking on management decisions.A better interpretation of change needs to identify the treatment effect based on clinical relevance for a given condition.There are a multiple set of measurement indices to serve this effect and most of them are used interchangeably without clear demarcation on their differences.This article details the various quantification metrics used to evaluate the treatment effect using PROMs,their limitations and the scope of usage and implementation in clinical practice.

Influence of the Different Prosthesis Designs on Subjective Functional Evaluation after TKA: Medium-Term Outcome Using the 2011 Knee Society Score

Background: Patient-reported outcome (PRO) has become the focus of increased attention in the assessment of total knee arthroplasty (TKA). The purpose of this study was to investigate whether different prosthesis designs affected postoperative patient-reported performance. Materials and Methods: We reviewed 216 patients (234 knees) implanted with the Press-Fit Condylar Sigma prosthesis at our institution between January 2009 and December 2011. This study included 76 knees with fixed-bearing cruciate-retaining (FB-CR), 78 knees with fixed-bearing posterior-stabilized (FB-PS), and 80 knees with mobile-bearing posterior-stabilized (MB-PS) designs. The mean follow-up was 8.0 ± 0.74 years. Preoperative and follow-up ratings according to the 2011 Knee Society Score (2011 KSS), range of motion (ROM), and standing femoro-tibial angle (FTA) were obtained for all patients. Additionally, Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores were collected at last follow-up. Results: Three separate subscales of the 2011 KSS of the three cohorts were significantly improved post-operatively compared to the pre-operative values (p < 0.05), except for expectation scores. At the time of follow-up, significantly higher the 2011 Knee Society Functional Scores <2011 KSFS> (P = 0.016) were found in the PS group. In particular, there were significant differences in advanced activities of the 2011 KSFS among the three groups (P = 0.017). Satisfaction scores showed no difference among the three groups (P = 0.251). On the other hand, WOMAC and expectation scores were significantly better in the PS groups. (P = 0.003, P = 0.004). ROM in the MB-PS group (124.0°) was better than that in FB-PS (119.4°) and FB-CR (118.9°) (P = 0.005). On the other hand, additional surgery was needed in five PS knees. Conclusion: The PS prostheses had superior 2011 KSFS, expectation scores, WOMAC scores and ROM than the CR prostheses. In contrast, the postoperative prosthesis-related complication rates were lower with CR prostheses. Further detailed evaluation is necessary to determine whether the characteristics of the different prostheses affect PRO.

A Systematic Review of Patient-Reported Outcome Measurement for Psoriasis in Chinese Population

Objective To review the development of patient-reported outcome measurement(PROM)for patients with psoriasis in China,and to analyze the main results and methodology.Methods The systematic review method of COSMIN(consensus-based standards for the selection of health measurement instruments)was adopted,and the domestic and foreign databases were searched to find the patient-reported outcome scales based on Chinese psoriasis patients.Then,the included studies were evaluated by using COSMIN risk of bias checklist.Results and Conclusion A total of 3 studies were included,involving 3 scales.We found that the quality evaluation of the development process of the 3 scales was not high,and there were large methodological loopholes in the whole cycle of scale development and verification.The included studies have many problems such as low extrapolation,poor quality,and lack of validation,which can provide more insights for the quality control requirements of the whole cycle of scale development in the future.

Literature review and analysis of the development of health outcomes assessment instruments in Chinese medicine

OBJECTIVE： To evaluate the development of health outcomes assessment instruments in Chinese medicine. METHODS： A comprehensive literature search for all published articles in China National Knowledge Infrastructure Database, Chongqing VIP Database and WANFANG Data was conducted. The studies that met the inclusion and exclusion criteria were used to extract information according to a predesigned assessment instrument. RESULTS： A total of 97 instruments for health outcome assessment in Chinese medicine were identified. Of these questionnaires, 7 were generic, 12 were condition-specific and 78 were disease-specific. All instruments were suitable for adults, children, and both men and women. These instruments aimed to evaluate the health-related quality of life, signs and symptoms as well as patient satisfaction and doctor-reported outcome. However, the descriptions were poorly constructed for some of the most basic parameters, such as the domains and items, administrative mode, response options, memory recall periods, burden evaluation, format, copyright, content validity, and other properties. CONCLUSION： The instrument development for health outcomes assessment in Chinese medicine is increasing rapidly; however, there are many limitations in current methodologies and standards, and further studies are needed.

Patient-reported dissatisfaction following second side in staged bilateral total knee arthroplasty: A systematic review

BACKGROUND Around one third of patients who undergo total knee arthroplasty(TKA)will eventually have the contralateral knee replaced.Overall patient satisfaction after staged bilateral total knee arthroplasty procedures performed on different days is reportedly similar to unilateral TKA.Nevertheless,in our anecdotal experience patients often report less satisfying outcomes following the second side.A cursory review of available literature tended to confirm that observation.We sought therefore to consolidate all of the available data on this issue to further investigate this phenomenon.AIM To consolidate available published data revealing satisfaction scores among patients following staged bilateral TKA,and to evaluate the phenomenon of less satisfying results following TKA2.METHODS A systematic review of available literature reporting on satisfaction with TKA1 and TKA2 after staged bilateral knee arthroplasty was undertaken using PubMed,Google Scholar,and Embase.From 427 records,five full-length articles met criteria for inclusion in the meta-analysis.The data were then extracted and assessed on the basis of the Reference Citation Analysis(https://www.referencecitationanalysis.com/).RESULTS A total of 1889 patients with an average age of 68(range:38–92)underwent staged bilateral TKA with outcomes reported at 1 year following each TKA with a mean 21.9 mo between surgeries(range:2 d to 14.5 years).Overall satisfaction with both knees was 83.70%(1581)and dissatisfaction with both knees was 2.75%(52).In the remaining 13.56%(256)who were dissatisfied with one side,61.0%were dissatisfied with TKA2,and 39.0%were dissatisfied with TKA1.Patient-reported outcome scores for TKA2 were frequently lower than TKA1 even in patients reporting overall satisfaction with both knees.CONCLUSION At 1-year follow-up,there was a 50%greater risk of dissatisfaction with TKA2 among the 13.56%of patients reporting dissatisfaction in one knee after staged bilateral TKA.Whether the interval between procedures or long-term follow-up changes these results requires further investigation.

Technological developments enable measuring and using patientreported outcomes data in orthopaedic clinical practice

Patient-reported outcomes measures form the backbone of outcomes evaluation in orthopaedics,with most of the literature now relying on these scoring tools to measure change in patient health status.This patient-reported information is increasingly collected routinely by orthopaedic providers but use of the data is typically restricted to academic research.Developments in electronic data capture and the outcome tools themselves now allow use of this data as part of the clinical consultation.This review evaluates the role of patient reported outcomes data as a tool to enhance daily orthopaedic clinical practice,and documents how developments in electronic outcome measures,computer-adaptive questionnaire design and instant graphical display of questionnaire can facilitate enhanced patientclinician shared decision making.

Patient-Reported Outcomes of Postoperative NSCLC Patients with or without Staged Chinese Herb Medicine Therapy during Adjuvant Chemotherapy (NALLC 2): A Randomized, Double-Blind, Placebo-Controlled Trial

Objective:To investigate whether the combination of chemotherapy with staged Chinese herbal medicine(CHM) therapy could enhance health-related quality of life(QoL) in non-small-cell lung cancer(NSCLC)patients and prolong the time before deterioration of lung cancer symptoms,in comparison to chemotherapy alone.Methods:A prospective,double-blind,randomized,controlled trial was conducted from December 14,2017 to August 28,2020.A total of 180 patients with stage ⅠB-ⅢA NSCLC from 5 hospitals in Shanghai were randomly divided into chemotherapy combined with CHM(chemo+CHM) group(120 cases) or chemotherapy combined with placebo(chemo+placebo) group(60 cases) using stratified blocking randomization.The European Organization for Research and Treatment of Cancer(EORTC) Quality-of-Life-Core 30 Scale(QLQ-C30) was used to evaluate the patient-reported outcomes(PROs) during postoperative adjuvant chemotherapy in patients with early-stage NSCLC.Adverse events(AEs) were assessed in the safety analysis.Results:Out of the total 180 patients,173 patients(116in the chemo+CHM group and 57 in the chemo+placebo group) were included in the PRO analyses.The initial mean QLQ-C30 Global Health Status(GHS)/QoL scores at baseline were 57.16±1.64 and 57.67±2.25 for the two respective groups(P>0.05).Compared with baseline,the chemo+CHM group had an improvement in QLQ-C30GHS/QoL score at week 18 [least squares mean(LSM) change 17.83,95% confidence interval(CI) 14.29 to 21.38].Conversely,the chemo+placebo group had a decrease in the score(LSM change-13.67,95% CI-22.70 to-4.63).A significant between-group difference in the LSM GHS/QoL score was observed,amounting to 31.63 points(95% CI25.61 to 37.64,P<0.001).The similar trends were observed in physical functioning,fatigue and appetite loss.At week 18,patients in the chemo+CHM group had a higher proportion of improvement or stabilization in GHS/QoL functional and symptom scores compared to chemo+placebo group(P<0.001).The median time to deterioration was longer in the chemo+CHM group for GHS/QoL score [hazard ratio(HR)=0.33,95% CI 0.23 to 0.48,P<0.0010],physical functioning(HR=0.43,95% CI 0.25 to 0.75,P=0.0005),fatigue(HR=0.47,95% CI 0.30 to 0.72,P<0.0001) and appetite loss(HR=0.65,95% CI 0.42to 1.00,P=0.0215).The incidence of AEs was lower in the chemo+CHM group than in the chemo+placebo group(9.83% vs.15.79%,P=0.52).Conclusion:The staged CHM therapy could help improve the PROs of postoperative patients with early-stage NSCLC during adjuvant chemotherapy,which is worthy of further clinical research.(Registry No.NCT03372694)

NT-proBNP、Hcy联合BPV对子痫前期孕妇不良妊娠结局的预测价值

目的探讨N末端B型脑钠肽前体(NT-proBNP)、同型半胱氨酸(Hcy)联合动态血压变异性(BPV)对子痫前期(PE)孕妇妊娠结局的预测价值。方法选取2020年10月至2023年10月广东省中山市小榄人民医院收治的PE孕妇203例为研究对象,根据妊娠结局分为结局良好组(n=129)和结局不良组(n=74)。比较2组的临床特征,分析影响PE孕妇不良妊娠结局的危险因素,以及NT-proBNP、Hcy联合BPV对PE孕妇不良妊娠结局的预测价值。结果结局良好组的血小板计数高于结局不良组,NT-proBNP、Hcy水平低于结局不良组(P<0.05)。结局良好组的收缩压变异性(SBPV)、舒张压变异性(DBPV)小于结局不良组(P<0.05)。Logistic回归分析显示,NT-proBNP、Hcy、SBPV、DBPV为PE孕妇不良妊娠结局的独立危险因素(P<0.05),血小板计数是PE孕妇不良妊娠结局的保护因素。受试者工作特征(ROC)曲线分析显示,NT-proBNP、Hcy、SBPV、DBPV预测PE患者不良妊娠结局的曲线下面积(AUC)分别为0.719、0.851、0.864、0.923,联合预测的AUC为0.962,敏感度为0.973,特异度为0.946。结论NT-proBNP、Hcy水平升高和BPV增大是PE孕妇不良妊娠结局的影响因素,NT-proBNP、Hcy联合BPV对PE孕妇妊娠结局具有良好的预测价值。

Transperineal prostate biopsies for diagnosis of prostate cancer are well tolerated： a prospective study using patient-reported outcome measures

We aimed to determine short-term patient-reported outcomes in men having general anesthetic transperineal （TP） prostate biopsies. A prospective cohort study was performed in men having a diagnostic TP biopsy. This was done using a validated and adapted questionnaire immediately post-biopsy and at follow-up of between 7 and 14 days across three tertiary referral hospitals with a response rate of 51.6%. Immediately after biopsy 43/201 （21.4%） of men felt light-headed, syncopal, or suffered syncope. Fifty-three percent of men felt discomfort after biopsy （with 95% scoring 〈5 in a 0-10 scale）. Twelve out of 196 men （6.1%） felt pain immediately after the procedure. Despite a high incidence of symptoms （e.g., up to 75% had some hematuria, 47% suffered some pain）, it was not a moderate or serious problem for most, apart from hemoejaculate which 31 men suffered. Eleven men needed catheterization （5.5%）. There were no inpatient admissions due to complications （hematuria, sepsis）. On repeat questioning at a later time point, only 25/199 （12.6%） of men said repeat biopsy would be a significant problem despite a significant and marked reduction in erectile function after the procedure. From this study, we conclude that TP biopsy is well tolerated with similar side effect profiles and attitudes of men to repeat biopsy to men having TRUS biopsies. These data allow informed counseling of men prior to TP biopsy and a benchmark for tolerability with local anesthetic TP biopsies being developed for clinical use.