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.

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) .

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.

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.

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.

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.

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.

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.

出入院NT-proBNP比值与非选择危重症患者住院结局的关系分析

目的 观察出院与入院氨基末端脑钠肽前体(NT-proBNP)比值与非选择危重症患者住院结局的关系。方法 选取2013年1月至2018年12月我院重症监护室收治的非选择危重症住院患者108例,记录基线NT-proBNP、肌钙蛋白I、肌酸激酶、肌红蛋白、肌酐、尿素氮、钠离子、钾离子、白蛋白、血色素、心率、血压等,计算出院与入院NT-proBNP比值,分析与非选择危重症患者住院结局的关系。结果 共纳入非选择危重症患者108例,其中男74例(68%)。临床结局出现恶化的患者67例(62%),在调整了年龄、性别、收缩压和血色素后,多远逻辑回归分析结果显示NT-proBNP比值是为非选择重症患者住院结局恶化的独立危险因素(OR=1.27,95%CI 1.07~1.51,P=0.006),NT-proBNP比值增高患者住院结局恶化风险为NT-proBNP比值降低患者的8.34倍(95%CI 3.31~21.02,P<0.001)。结论 出院与入院NTproBNP比值增高与危重症患者的不良住院结局相关。

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.

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.

Acupuncture-moxibustion for lung cancer patient-reported outcomes:A systematic review and meta-analysis protocol

Background:Lung cancer is one of the most common cancers globally with high incidence and mortality rate.Acupuncture and moxibustion have been used as adjuvant therapies to relieve the symptoms and complications of lung cancer.At present,acupuncture and moxibustion can partially improve the quality of life(QOL)of cancer patients.However,the evidence that acupuncture and moxibustion can improve patient-reported outcomes(PROs)in patients with lung cancer is still insufficient.We aimed to conduct a systematic review and meta-analysis of published randomized controlled trials(RCTs)to determine whether acupuncture and moxibustion can improve PROs among patients with lung cancer,providing a support basis for acupuncture and moxibustion inclusion in relevant guidelines.Methods:We will search the following electronic databases:PubMed,Embase,Cochrane Library,Web of Science,CNKI,CQVIP,Wanfang Data,Sinomed,and gray literature including the ClinicalTrials.gov Database(clinicaltrials.gov)and Chinese Clinical Trial Register(chictr.org.cn).All English and Chinese articles will be searched until July 1,2021.Two researchers independently extracted data.Any disagreement was resolved by discussion until consensus was reached or by consulting a third researcher.The primary outcomes mainly included the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire(EORTC QLQ-C30),functional assessment of cancer therapy-lung(FACT-L),and Karnofsky Performance Status(KPS).The secondary outcomes included improvement of individual lung cancerrelated symptoms and the safety of acupuncture intervention.Discussion:Our study is the first to focus on the PROs of acupuncture and moxibustion for lung cancer treatment.The results will contribute to a deeper understanding of the evidence distribution of acupuncture and moxibustion in PROs,which may support the use of acupuncture and moxibustion in lung cancer patients.

脑卒中PRO量表的信度效度分析

目的考察自行研制的用于临床疗效评价和新药临床试验的脑卒中患者报告的临床结局(PRO)评价量表的科学性。方法采用脑卒中PRO量表对595例样本(485例脑卒中患者、110例"健康人")进行自评量表式调查,对量表进行信度、效度和可行性的考核,并针对性别可能产生的量表选填差异进行项目功能差异分析。结果总量表的克朗巴赫系数为0.905。结构效度结果显示量表多维度的测量满足专业上的预期构想。项目功能差异(DIF)结果提示,仅PHD9和PSD3两个条目存在跨性别DIF。抽样调查脑卒中患者,量表回收率为99.2%,有效率为98.8%,平均作答时间为8.9分钟。结论本课题研制的脑卒中PRO量表具有较好的信度、效度、公平性和可行性。

慢性心衰PRO量表条目的初步筛选

目的研制适合国人的基于心力衰竭患者报告的临床结局评价量表。方法按照国际PRO量表的研制规范,通过询问患者主要和最期待改善的症状,查阅大量相关文献形成条目池;再通过各领域的专家和患者对形成的条目池和语言表达进行修正,形成初始量表。用初始量表分别在太原不同区的八所医院发放155份问卷进行预调查,回收后利用经典测量理论和项目反应理论(IRT)进行条目筛选和维度调整形成初量表;然后再在上述的八所医院进行大规模的正式调查,利用大规模调查的信息数据再一次进行条目筛选,形成终选量表。结果终选量表共有57个条目,分为生理领域、心理领域、社会领域、治疗领域4个领域,共计12个维度。结论形成的终选量表基本符合理论框架,较好的反映了慢性心衰患者生命质量的内涵。

基于多量表对乳腺癌患者自体乳房重建与植入物乳房重建术后患者报告结局的量化研究

目的对乳腺癌患者行自体乳房重建与植入物乳房重建术后患者报告结局(patient-reported outcome,PRO)进行评估。方法选取2020年1月至2021年6月在复旦大学附属肿瘤医院乳腺外科行乳房重建手术的患者,其中行自体乳房重建111例,行植入物乳房重建108例。应用中文版Breast-Q 2.0量表、乳腺癌特异性量表QLQ-BR23、EORTC生命质量测定量表QLQ-C30,通过问卷形式调查两组患者术后18个月的PRO。结果自体重建组中Ⅲ期乳腺癌高于植入物重建组(64.9%vs.44.4%,P<0.001),自体重建组在术前行新辅助治疗、术后放疗方面高于植入物重建(P<0.001),自体重建组术后行化疗、内分泌治疗低于植入物重建组(P<0.05)。基于BreastQ 2.0量表的研究显示自体重建组对乳房满意度高于植入物重建组(59.28±17.20 vs.54.94±14.48,P<0.05)。基于QLQ-BR23量表的研究显示在上肢症状领域自体重建组高于植入物重建组(20.02±20.80 vs.12.65±16.18,P<0.05)。基于QLQ-C30量表的研究显示患者在各功能领域及症状领域对比差异均无统计学意义。两组患者在术后社会回归人数与回归时间的差异无统计学意义。结论乳房重建可提高乳腺癌患者PRO,肿瘤学因素会影响乳腺癌重建方式的选择,自体乳房重建患者对乳房外形满意度更高,但是上肢症状(如肿胀、疼痛)较植入物重建组明显,这与自体重建患者行腋窝淋巴结清扫比例较高有关。两组患者在生活质量和社会回归方面差异不明显。