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 pati...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.展开更多
Objective:To develop a patient-reported traditional Chinese medicine kidney deficiency pattern(TCMKDP)scale for colorectal cancer(CRC)patients and evaluate its reliability and validity.Methods:We administered the TCM-...Objective:To develop a patient-reported traditional Chinese medicine kidney deficiency pattern(TCMKDP)scale for colorectal cancer(CRC)patients and evaluate its reliability and validity.Methods:We administered the TCM-KDP questionnaire to postoperative patients with stage II and III CRC as part of a multicenter randomized controlled trial(RCT)conducted in China from December 2018 to September 2021.The TCM-KDP scale consists of eight items on patient-reported symptoms and is scored on a five-point Likert scale.The scale’s reliability was assessed using Cronbach’s a and test-retest reliability,while content validity was evaluated with the content validity index.We compared the differences in serum cytokine levels and other clinical factors between patients with higher and lower KDP scores.Results:Of the 378 patients analyzed in the original RCT,352(93.2%)completed the TCM-KDP questionnaire.The Cronbach’s a of the eight-item TCM-KDP scale was 0.734,and the test-retest reliability was 0.745.Our exploratory factor analysis yielded eight factors that explained the variance of 50.34%.The mean TCM-KDP score was 2.80±0.92.Compared with patients with stage II CRC,those with stage III CRC had significantly higher TCM-KDP scores(2.25 vs.2.50,P=.026).We categorized all patients into highor low-KDP score groups(the cut-off score was 2.8).Patients with lower TCM-KDP scores had significantly higher serum interleukin-1b expression levels(P=.04).Conclusion:The patient-reported TCM-KDP scale demonstrated relatively good feasibility,internal consistency,and test-retest reliability among patients with CRC.Future studies could apply this scale to other cancer types and diseases.展开更多
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...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.展开更多
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 w...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.展开更多
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 measurement...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) .展开更多
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 ...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.展开更多
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 condition...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.展开更多
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 procedur...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.展开更多
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 staff...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.展开更多
Objective: To investigate patient-reported factors those promote or inhibit food intake in older people after discharge from hospital. Background: Disease-related malnutrition leads to poor appetite, decreased food in...Objective: To investigate patient-reported factors those promote or inhibit food intake in older people after discharge from hospital. Background: Disease-related malnutrition leads to poor appetite, decreased food intake and affects convalescence negatively. Design: Secondary analysis of two intervention groups from an RCT. Methods: 111 older adults received nutritional follow-up one, two and four weeks after discharge. Self-reported food intake was classified as adequate (AQ) or inadequate (IAQ) energy intake two weeks after discharge. Data on inhibitory and promoting factors, body weight, ADL-function, readmission and mortality were analysed and comparison made between AQ and IAQ groups. Results: More IAQ participants reported fatigue and eating all meals alone. All participants lost body weight, but more IAQ participants lost body weight. More IAQ participants were readmitted to hospital 30 days after discharge. Conclusion: “Fatigue” and “eating all meals alone” affect food intake negatively, leading to loss of body weight and readmission to hospital.展开更多
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 ai...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.展开更多
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 ...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.展开更多
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(cons...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.展开更多
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 t...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.展开更多
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 lu...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.展开更多
BACKGROUND Thermal ablation(TA)has been proved to be effective and safe as minimally invasive treatment method for thyroid nodules.However,patients'experience during the procedures and quality of life varies among...BACKGROUND Thermal ablation(TA)has been proved to be effective and safe as minimally invasive treatment method for thyroid nodules.However,patients'experience during the procedures and quality of life varies among operators.AIM To explore strategy to improve quality of life and subjective experiences during TA for papillary thyroid carcinoma(PTC)based on thermal field management(TFM).METHODS This retrospective propensity-matched cohort study was conducted in a single center.A total of 490 patients with PTC treated with TA from September 2023 to August 2024 were studied and divided into two groups(TFM group and non-TFM group)according to treatment strategies.Propensity score matching(PSM)was used to control for confounding factors.Complications,side effect and com-plaints of patients were compared between the two groups.RESULTS A total of 113 patients(41.7±10.6;31 men,82 women)were assigned to the TFM group,and 377 patients(mean age,41.1±10.7 year;116 men,261 women)were assigned to the non-TFM group.After PSM,a total of 108 patients were included in the TFM group,and 216 patients were included in the non-TFM group.The median follow-up was 10 months(range from 4-15 months).The incidence of voice change in the TFM group was significantly lower than that in the non-TFM group(0.9%vs 6.5%;P=0.049).Although there was no statistically significant difference in rate of pain between the two groups,the proportion of complaining of pain in the TFM group was numerically lower than that in the non-TFM group(3.7%vs 9.7%,P=0.090).CONCLUSION TFM,as a novel procedural optimization technique,can effectively improve quality of life and subjective expe-riences of patients during TA for PTC.展开更多
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 prol...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)展开更多
Objective： To evaluate a scale of patient-reported outcomes for the assessment of myasthenia gravis patients （MG-PRO） in China. Methods： A total of 100 MG patients were interviewed for the field testing. Another 5...Objective： To evaluate a scale of patient-reported outcomes for the assessment of myasthenia gravis patients （MG-PRO） in China. Methods： A total of 100 MG patients were interviewed for the field testing. Another 56 MG patients were selected and assessed with the MG-PRO scale before treatment and at 1, 2 and 4 weeks after treatment. The classical test theory and item response theory （IRT） were used to assess the psychometric characteristics of the MG-PRO scale, Results： The MG-PRO scale included 4 dimensions： physical, psychological, social environment, and treatment. Confirmatory factor analysis showed that each dimension was consistent with the theoretical construct. The scores of the physical and psychological dimensions increased significantly at 1 week after treatment （P〈0.05）. All the dimension scores and the MG-PRO score increased significantly at 2 and 4 weeks after treatment （P〈0.05）. IRT showed that person separation indices were greater than 0.8, most of the item fit residual statistics were within ＋ 2.5, and no item had uniform or non-uniform differential item functioning （DIF） between gender and age （〈40, 〉140）. Conclusions： The MG-PRO scale is valid for measuring the quality of life （QOL） of MG patients, with good reliability, validity, responsiveness, and good psychometric characteristics from IRT. It can be applied to evaluate the QOL of MG patients and to assess treatment effects in clinical trials.展开更多
The uremic symptoms of advanced chronic kidney disease(CKD)can severely impair physical function,psychological health and social life.Some patients,especially for the older,chose conservative kidney management(CKM)and...The uremic symptoms of advanced chronic kidney disease(CKD)can severely impair physical function,psychological health and social life.Some patients,especially for the older,chose conservative kidney management(CKM)and Traditional Chinese medicine(TCM)but not dialysis in this stage.To measure the patients-reported outcome(PRO)from these people,Advanced Chronic Kidney展开更多
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 ...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.展开更多
文摘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.
基金supported by Scientific and Technological Innovation Project of China Academy of Chinese Medical Sciences,Youth Program(C12021A01819)China National Key R&D Plan Special Program for Modernization of Traditional Chinese Medicine,Ministry of Science and Technology of the People’s Republic of China,2017YFC1700604+1 种基金Scientific and Technological Innovation Project of China Academy of Chinese Medical Sciences(CI2021B009)Innovation Team and Talents Cultivation Program of National Administration of Traditional Chinese Medicine(ZYYCXTD-C-202205).
文摘Objective:To develop a patient-reported traditional Chinese medicine kidney deficiency pattern(TCMKDP)scale for colorectal cancer(CRC)patients and evaluate its reliability and validity.Methods:We administered the TCM-KDP questionnaire to postoperative patients with stage II and III CRC as part of a multicenter randomized controlled trial(RCT)conducted in China from December 2018 to September 2021.The TCM-KDP scale consists of eight items on patient-reported symptoms and is scored on a five-point Likert scale.The scale’s reliability was assessed using Cronbach’s a and test-retest reliability,while content validity was evaluated with the content validity index.We compared the differences in serum cytokine levels and other clinical factors between patients with higher and lower KDP scores.Results:Of the 378 patients analyzed in the original RCT,352(93.2%)completed the TCM-KDP questionnaire.The Cronbach’s a of the eight-item TCM-KDP scale was 0.734,and the test-retest reliability was 0.745.Our exploratory factor analysis yielded eight factors that explained the variance of 50.34%.The mean TCM-KDP score was 2.80±0.92.Compared with patients with stage II CRC,those with stage III CRC had significantly higher TCM-KDP scores(2.25 vs.2.50,P=.026).We categorized all patients into highor low-KDP score groups(the cut-off score was 2.8).Patients with lower TCM-KDP scores had significantly higher serum interleukin-1b expression levels(P=.04).Conclusion:The patient-reported TCM-KDP scale demonstrated relatively good feasibility,internal consistency,and test-retest reliability among patients with CRC.Future studies could apply this scale to other cancer types and diseases.
文摘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.
文摘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.
文摘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) .
基金supported by the Health Bureau of Shanghai City(201440029)
文摘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.
基金National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health,No.U01AR067138.
文摘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.
文摘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.
文摘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.
文摘Objective: To investigate patient-reported factors those promote or inhibit food intake in older people after discharge from hospital. Background: Disease-related malnutrition leads to poor appetite, decreased food intake and affects convalescence negatively. Design: Secondary analysis of two intervention groups from an RCT. Methods: 111 older adults received nutritional follow-up one, two and four weeks after discharge. Self-reported food intake was classified as adequate (AQ) or inadequate (IAQ) energy intake two weeks after discharge. Data on inhibitory and promoting factors, body weight, ADL-function, readmission and mortality were analysed and comparison made between AQ and IAQ groups. Results: More IAQ participants reported fatigue and eating all meals alone. All participants lost body weight, but more IAQ participants lost body weight. More IAQ participants were readmitted to hospital 30 days after discharge. Conclusion: “Fatigue” and “eating all meals alone” affect food intake negatively, leading to loss of body weight and readmission to hospital.
文摘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.
文摘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.
文摘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.
文摘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.
基金Supported by the Project BEBPC-TCM2019XZZX-ZJ0011Shanghai Clinical Research Center for Acupuncture and Moxibustion Accelerating20MC1920500Clinical Key Specialty Construction Foundation of Shanghaishslczdzk04701。
文摘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.
基金Supported by National High Level Hospital Clinical Research Funding,No.2022-NHLHCRF-PY-07National Natural Science Foundation of China,No.62176268.
文摘BACKGROUND Thermal ablation(TA)has been proved to be effective and safe as minimally invasive treatment method for thyroid nodules.However,patients'experience during the procedures and quality of life varies among operators.AIM To explore strategy to improve quality of life and subjective experiences during TA for papillary thyroid carcinoma(PTC)based on thermal field management(TFM).METHODS This retrospective propensity-matched cohort study was conducted in a single center.A total of 490 patients with PTC treated with TA from September 2023 to August 2024 were studied and divided into two groups(TFM group and non-TFM group)according to treatment strategies.Propensity score matching(PSM)was used to control for confounding factors.Complications,side effect and com-plaints of patients were compared between the two groups.RESULTS A total of 113 patients(41.7±10.6;31 men,82 women)were assigned to the TFM group,and 377 patients(mean age,41.1±10.7 year;116 men,261 women)were assigned to the non-TFM group.After PSM,a total of 108 patients were included in the TFM group,and 216 patients were included in the non-TFM group.The median follow-up was 10 months(range from 4-15 months).The incidence of voice change in the TFM group was significantly lower than that in the non-TFM group(0.9%vs 6.5%;P=0.049).Although there was no statistically significant difference in rate of pain between the two groups,the proportion of complaining of pain in the TFM group was numerically lower than that in the non-TFM group(3.7%vs 9.7%,P=0.090).CONCLUSION TFM,as a novel procedural optimization technique,can effectively improve quality of life and subjective expe-riences of patients during TA for PTC.
基金Supported by Project of Shanghai Municipal Commission of Science and Technology(Nos.16401970700 and 22Y31920400)。
文摘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)
基金Supported by the Major State Basic Research Development Program of China(973 Program,No.2005CB523500)the Key Project of the National 11th Five Year Research Program of China(No.2006BAI04A12)
文摘Objective： To evaluate a scale of patient-reported outcomes for the assessment of myasthenia gravis patients （MG-PRO） in China. Methods： A total of 100 MG patients were interviewed for the field testing. Another 56 MG patients were selected and assessed with the MG-PRO scale before treatment and at 1, 2 and 4 weeks after treatment. The classical test theory and item response theory （IRT） were used to assess the psychometric characteristics of the MG-PRO scale, Results： The MG-PRO scale included 4 dimensions： physical, psychological, social environment, and treatment. Confirmatory factor analysis showed that each dimension was consistent with the theoretical construct. The scores of the physical and psychological dimensions increased significantly at 1 week after treatment （P〈0.05）. All the dimension scores and the MG-PRO score increased significantly at 2 and 4 weeks after treatment （P〈0.05）. IRT showed that person separation indices were greater than 0.8, most of the item fit residual statistics were within ＋ 2.5, and no item had uniform or non-uniform differential item functioning （DIF） between gender and age （〈40, 〉140）. Conclusions： The MG-PRO scale is valid for measuring the quality of life （QOL） of MG patients, with good reliability, validity, responsiveness, and good psychometric characteristics from IRT. It can be applied to evaluate the QOL of MG patients and to assess treatment effects in clinical trials.
基金supported by MOST/SATCM of the People's Republic of China grant2013BAI02B04
文摘The uremic symptoms of advanced chronic kidney disease(CKD)can severely impair physical function,psychological health and social life.Some patients,especially for the older,chose conservative kidney management(CKM)and Traditional Chinese medicine(TCM)but not dialysis in this stage.To measure the patients-reported outcome(PRO)from these people,Advanced Chronic Kidney
文摘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.
