Outcome Index Research Articles

Behavioral and health outcomes from the NRG Oncology/NSABP B-36 trial comparing two different adjuvant therapy regimens for early-stage node-negative breast cancer.

The NSABP B-36 compared four cycles of doxorubicin and cyclophosphamide (AC) with six cycles of 5-fluorouracil, epirubicin, and cyclophosphamide (FEC-100) in node-negative early-stage breast cancer. A sub-study within B-36, focusing on symptoms, quality of life (QOL), menstrual history (MH), and cardiac function (CF) was conducted. Patients completed the QOL questionnaire at baseline, during treatment, and every 6months through 36months. FACT-B Trial Outcome Index (TOI), symptom severity, and SF-36 Vitality and Physical Functioning (PF) scales scores were compared between the two groups using a mixed model for repeated measures analysis. MH was collected at baseline and subsequently assessed if menstrual bleeding occurred within 12months prior to randomization. Post-chemotherapy amenorrhea outcome was examined at 18months and was defined as lack of menses in the preceding year. Logistic regression was used to test for association of amenorrhea and treatment. CF assessment was done at baseline and 12months. Correlation analysis was used to address associations between changes in baseline and 12-month PF and concurrent CF changes measured by LVEF. FEC-100 patients had statistically significantly lower TOI scores during chemotherapy (P = 0.02) and at 6months (P < 0.001); lower Vitality score at 6months (P < 0.01), and lower PF score during the first year than AC patients. There were no statistically significant QOL score differences between the two groups beyond 12months. No significant differences in symptom severity between the two groups were observed. Rates of amenorrhea were significantly different between FEC-100 and AC (67.4% vs. 59.1%, P < 0.001). There was no association between changes in LVEF and PF (P = 0.38). Statistically significant QOL differences between the two groups favored AC; however, the magnitude was small and unlikely to be clinically meaningful. There was a clinical and statistically significant difference in risk for amenorrhea, favoring AC. NCT00087178; Date of registration: 07/08/2004.

Prognostic effects of health-related quality of life at baseline and early change in health-related quality of life on response to treatment and survival in patients with advanced lung cancer: a prospective observational study in China

ObjectivesTo investigate the relationship among baseline health-related quality of life (HRQoL), early changes in HRQoL from baseline to completion of the first cycle of chemotherapy, and prognosis in patients with...

Hearing outcome after tympanoplasty type III

PurposeWe assessed overall hearing outcome after tympanoplasty type III in chronically infected ears with cholesteatoma (CH) and without cholesteatoma: otitis media chronica mesotympanalis, tympanosclerosis, and adhesive process (COM_T_AP).Methods303 surgeries were evaluated: 229 CH-group and 74 COM_T_AP-group. Air-bone gaps (PTA-ABG) with pure-tone averages (PTA-4) at four frequencies (0.5, 1, 2 and 4 kHz) were compared preoperatively, early postoperatively (< 40 days) and late postoperatively (40–400 days). Hearing outcome was compared in various types of middle-ear reconstruction and in smokers and non-smokers. Correlations between hearing outcome and predictive staging indices were evaluated: Middle Ear Risk-Index (MER-I) and Ossiculoplasty Outcome Parameter Staging-Index (OOPS-I).ResultsMean PTA-ABG in the CH-group increased from 20.9 ± 11.3 dB to 22.3 ± 10.4 dB early postoperatively and decreased significantly to 19.2 ± 10.1 dB late postoperatively. Mean PTA-ABG in the COM_T_AP-group decreased significantly from 27.3 ± 10.9 dB to 20.6 ± 10.9 dB early postoperatively and decreased to 20.0 ± 12.2 dB late postoperatively. No significant difference was seen between PTA-ABG-closures of partial or total ossicular replacement prosthesis (PORP/TORP) and cartilage ossiculoplasty in the CH-group. Patients receiving TORP showed a significantly higher preoperative PTA-ABG. All reconstruction types exhibited postoperative PTA-ABG around 20 dB. In the COM_T_AP-group, smokers had a significantly higher mean PTA-ABG early postoperatively; this equalized with that of non-smokers late postoperatively. PTA-ABG-closures and MER-I or OOPS-I were not significantly correlated.ConclusionTympanoplasty type III maintains hearing in patients with cholesteatoma and significantly improves hearing in chronically inflamed ears without cholesteatoma. All investigated ossicular replacement prostheses are equally beneficial. Healing postoperatively takes longer in smokers, but they eventually catch up with non-smokers.

Overview of systematic reviews of acupuncture for vascular cognitive impairment

To overview the methodological quality, report quality and evidence quality of the systematic review (SR) of acupuncture for vascular cognitive impairment ( VCI ). The SRs regarding acupuncture for VCI were searched in PubMed, Cochrane Library, EMbase, CNKI, SinoMed, Wanfang and VIP databases. The retrieval period was from the establishment of the database to September 24, 2020. The report quality, methodological quality and evidence quality of the included SRs were evaluated by PRISMA statement, the AMSTAR 2 tool and the GRADE system. A total of 22 SRs were included, including 102 outcome indexes. The methodological quality was generally low, with low scores on items 2, 5, 7, 10, 14, 15 and 16. The report quality was good, with scores ranging from 19 points to 24.5 points. The problems of report quality were mainly reflected in the aspects of structural abstract, program and registration, other analysis and funding sources. The level of outcome indexes of SRs was mostly low or very low, and the main leading factor was limitation, followed by inconsistency and inaccuracy. Acupuncture for VCI is supported by low quality evidence of evidence-based medicine, but the methodological quality and evidence body quality of relevant SRs are poor, and the standardization is needed to be improved.

Manual Lymph Drainage With Progressive Arm Exercises for Axillary Web Syndrome After Breast Cancer Surgery: A Randomized Controlled Trial.

This study aimed to determine the effectiveness of a physical therapist-designed program tailored to axillary web syndrome (AWS) in women after breast cancer surgery. A prospective, single-center, assessor-blinded, randomized controlled trial was conducted at the Physiotherapy in Women's Health Research Unit of the Alcalá University (Madrid, Spain). Ninety-six women with AWS were assigned to the physical therapy group (manual lymph drainage [MLD] using resorption strokes and arm exercises as if performing median nerve neurodynamic glide exercises with no neural loading; n = 48) or the control group (standard arm exercises; n = 48), with both groups receiving treatment 3 times a week for 3weeks. Both interventions included an educational component. Compared with the control group, the physical therapy group showed significant and clinically relevant improvements in the primary outcome (self-reported pain intensity) at the primary and 3-month follow-ups. Significant and clinically relevant differences between groups were also found in the secondary outcomes (shoulder active range of motion, shoulder disability, and physical and functional aspects of health-related quality of life) at the primary follow-up and in the secondary outcomes as well as the trial outcome index at the 3-month follow-up. No significant differences were found at the 6-month follow-up in either primary or secondary outcomes. The physical therapy program tailored to AWS was found to be effective for AWS symptoms in women after breast cancer surgery, both immediately after the program and after 3months. To our knowledge, this is the first appropriately designed study to demonstrate the effectiveness of MLD with progressive arm exercises for AWS. Clinicians and health service providers should consider how to provide survivors of breast cancer with AWS the opportunity to participate in physical therapy programs, including MLD with progressive arm exercises. For axillary web syndrome following breast cancer surgery, a physical therapist can design a treatment program including manual lymph drainage and progressive arm exercises, which has been shown to result in reduced pain and improved motion compared with standard arm exercises.

Analysis of outcome indexes in randomized controlled trials of traditional Chinese medicine for rheumatic heart disease

The present study analyzed the efficacy evaluation indexes of the randomized controlled trials(RCTs) of Chinese medi-cine in the treatment of rheumatic heart disease to lay the foundation for the construction of the corresponding core outcome index set. Clinical RCTs with a definite diagnosis of rheumatic heart disease were retrieved from CNKI, Wanfang, VIP, Sino Med, Pub Med, EMbase, and Cochrane Library from January 1, 2010, to December 31, 2020. Thirty-five RCTs were included, involving 3 314 patients and 41 efficacy evaluation indexes, which covered seven domains [traditional Chinese medicine(TCM) symptoms/syndromes, symp-toms/signs, physical and chemical examination, quality of life, long-term prognosis, economic evaluation, and safety events]. Physi-cal and chemical examination(56. 91%) and symptoms/signs(29. 27%) were the more frequently applied. The number of indexes used in a single trial ranged from 1 to 15, with an average of 4. The measurement time points of the top five indexes in the frequency of use were as follows: total response rate was reported at five measurement time points, ranging from 14 days to 6 months; left ventri-cular ejection fraction was measured at eight time points ranging from 5 days to 6 months; left ventricular end systolic diameter was measured at six time points, ranging from 5 days to 6 months; interleukin-2(IL-2) and tumor necrosis factor-α(TNF-α) were repor-ted 28 days after treatment. At present, there are many problems in the efficacy outcome indexes of RCTs in the treatment of rheumatic heart disease with TCM, such as large difference in quantity, unclear primary and secondary indexes, unreasonable selection of &quot; surro-gate indexes&quot;, insufficient attention to long-term prognostic indexes and safety event indexes, non-standard application of composite in-dexes, long measurement period, and lack of TCM characteristics. It is urgent to establish the core outcome set for TCM treatment of rheumatic heart disease.

Mobile application evaluation of the orthodontic treatment success and the degree of change based on the index of complexity, outcome, and need (ICON)

Aim: To evaluate the success of orthodontic treatment and the degree of change using the mobile application-based Index of Complexity, Outcome and Need (ICON) score calculation and also inquired the difference of ICON score in time calculation in the results of orthodontic treatment estimated using the mobile application-based method compared with the manual method. Materials and Methods: The present analytic observational study with a cross-sectional approach with a total sampling was performed using 31 pairs of study models in patients treated at the Orthodontic Department of Nala Husada Dental and Oral Hospital, Hang Tuah University, Surabaya, in 2020. The components calculated consisted of the treatment need, complexity assessment, treatment outcome, and the degree of change. The study model was estimated objectively alternating from employing the mobile application to the manual calculation; thus, the results of the calculation time were balanced. The data were analyzed by the independent t-test and Mann–Whitney test (P < 0.05). Results: The results revealed that the independent t-test significance values were P = 0.780 for care needs, P = 0.880 for the assessment of complexity, P = 0.745; P > 0.05 for the treatment outcome, and P = 0.903 for the degree of change. There was a significant difference between manual and mobile application calculation to examine ICON (P = 0.001). Conclusions: The calculation of ICON in the mobile application showed faster performance than the manual method that can be used to evaluate the orthodontics treatment need, complexity assessment, orthodontic treatment outcome, and the degree of change.

Research on Clinical Effectiveness of Aspirin for Treating Breast Cancer and Cell Protein Biomarkers on Aspirin Treatment in Drug-Resistant Estrogen Receptor-Positive Breast Cancer Cells

Background: Aspirin (ASA) has been reported to have an antitumor effect but the role of ASA in the prevention and treatment of breast cancer (BC) is still controversial. This study aimed to identify clinical effectiveness of ASA in the treatment of BC and explore the antitumor target proteins of ASA that may be involved in overcoming tamoxifen resistance in estrogen receptor (ER)-positive BC cells. Materials and Methods: Randomized controlled trials (RCTs) of ASA in the treatment of BC were queried from the databases, including PubMed, Web of Science, Cochrane Library, WanFang, and Chinese National Knowledge Infrastructure. According to the quality standard recommended in the Newcastle-Ottawa Scale (NOS), the outcome indexes were analyzed by RevMan 5.3 and Stata 12.0 software. Cell culture experiments were performed to explore the effect of tamoxifen combined with ASA on the proliferation of ER-positive BC cell lines MCF-7 and MCF-7/TAM. Cell cytotoxicity was determined by the 3-(4, 5-di-2-yl)-2, 5-ditetrazolium bromide (MTT) assay. A quantitative proteomic analysis was conducted between the control and experimental groups to identify differentially expressed proteins (DEPs). Subsequently, Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment analyses were used for bioinformatic analysis of DEPs. The protein expression in patients of ER-positive BC was analyzed by immunochemistry (IHC). Results: Nine RCTs including 162,381 patients were selected for this study. The meta-analysis revealed that daily ASA use, as compared with its non-use, was associated with a decreased risk of BC death: relative risk (RR) = 0.83%, 95% CI [0.73, 0.94], Z = 2.89, P = 0.004 (P

Outcome Indices for Evidence Production About Elementary School English Education:

Outcome Indices for Evidence Production About Elementary School English Education:

Efficacy of Manual Lymphatic Drainage for Breast Cancer-Related Lymphedema

Purpose: The effect of manual lymphatic drainage in patients with breast cancer is controversial. The purpose of this study is to evaluate the role of manual lymphatic drainage (MLD) in breast cancer-related lymphedema treatment. Methods: The electronic databases of EMBASE, PubMed, Web of Science, and The Cochrane Library were searched to find English articles on MLD which were published before January 2020. After two evaluators selected the studies and independently evaluated literature quality, meta-analysis was carried out with RevMan 5.3 software. The outcome index of lymphedema treatment changed in edema volume. Results: The study included six RCTs of 364 patients and the meta-analysis showed no significant difference in the effect of MLD for BCRL compared with other treatments (mean difference, 3.76; 95% confidence interval, -35.09 to 42.62; Z, 0.19; p = 0.850). Conclusion: MLD can relieve the body tissue, rapidly improve local condition, and enhance complete decongestive therapy (CDT) efficacy. MLD can prevent BCRL and improve the symptoms of stage I lymphedema. It should be widely applied to prevent BCRL from entering an irreversible state.

Heavy metal pollution of soils and risk assessment in Houston, Texas following Hurricane Harvey

In August 2017, after Hurricane Harvey made landfall, almost 52 inches of rain fell during a three-day period along the Gulf Coast Region of Texas, including Harris County, where Houston is located. Harris County was heavily impacted with over 177,000 homes and buildings (approximately 12 percent of all buildings in the county) experiencing flooding. The objective of this study was to measure 13 heavy metals in soil in residential areas and to assess cancer and non-cancer risk for children and adults after floodwaters receded. Between September and November 2017, we collected 174 surface soil samples in 10 communities, which were classified as “High Environmental Impact” or “Low Environmental Impact” communities, based on a composite metric of six environmental parameters. A second campaign was conducted between May 2019 and July 2019 when additional 204 soil samples were collected. Concentrations of metals at both sampling campaigns were higher in High Environmental Impact communities than in Low Environmental Impact communities and there was little change in metal levels between the two sampling periods. The Pollution Indices of lead (Pb), zinc, copper, nickel, and manganese in High Environmental Impact communities were significantly higher than those in Low Environmental Impact communities. Further, cancer risk estimates in three communities for arsenic through soil ingestion were greater than 1 in 1,000,000. Although average soil Pb was lower than the benchmark of the United States Environmental Protection Agency, the hazard indices for non-cancer outcomes in three communities, mostly attributed to Pb, were greater than 1. Health risk estimates for children living in these communities were greater than those for adults.

Methodological approach to assessing the quality of strategic planning activities

Subject. The article addresses a methodological approach to determining the feasibility of including an event that ensures the achievement of strategic targets in the implementation plan of a strategic planning document (i.e., a national project or a government program). Objectives. The purpose is to develop a methodological approach to create a balanced list of measures, which, if implemented, will have a positive effect on achieving strategic guidelines for sustainable socio-economic development and strengthening the economic security. Methods. The study rests on expert estimates for calculating the index of activities quality. The calculation of the index is based on the assessment of the index of incoming resources, the index of process, the index of outcome. The approach enables to consider elements associated with the initiation of a particular event, its successful implementation, and achievement of a specific outcome. Results. The study creates an approach to defining the degree of elaboration of the event and the feasibility of including it in the implementation plan of the strategic planning document. The method of expert estimates enables to neutralize some uncertainties and costs caused by initial data quality, empirical estimates of the degree of obtained results’ accuracy, and allocated resources. Conclusions. The working out of organizational, legal, and regulatory measures is only one element of strategizing. Further research should develop methodological approaches to the definition of targeted and critical values of the strategy system to implement a high-quality and operational monitoring.

Comparison of treatment outcomes as assessed by 3 indexes in subjects with Class I malocclusion treated by 3 different methods: A cross-sectional study

Various treatment modalities exist to improve and correct Class I malocclusion. This study was conducted to evaluate the outcomes of nonextraction (NE), premolar extraction (PME), and mandibular incisor extraction (MIE) treatment modalities in subjects presenting with Class I malocclusion. A cross-sectional study was conducted at a tertiary care hospital using pretreatment and posttreatment dental casts along with intraoral photographs of 90 orthodontic subjects. These subjects were divided equally into NE, PME, and MIE groups and scored using the Index of Orthodontic Treatment Need, Index of Complexity, Outcome, and Need (ICON), and peer assessment rating (PAR) indexes. Nonparametric tests were run to compare pretreatment and posttreatment scores and to evaluate the percentage and categorical changes for the treatment modalities. Pairwise comparisons were performed using the Mann-Whitney U test. Statistically significant differences (P≤0.001) were seen between the pretreatment and posttreatment scores for all modalities. Statistically significant improvements were seen between the 3 treatment modalities for the PAR (P= 0.010) and ICON (P= 0.003) indexes. Significant categorical improvements were found for the Aesthetic Component (AC) (P= 0.012) among the 3 groups. Pairwise comparison revealed significant differences between the NE and MIE groups (ICON, P= 0.001; AC, P= 0.018) and PME and MIE groups (PAR, P= 0.002; ICON, P= 0.007; AC, P= 0.007). Posttreatment scores of all indexes were reduced, with significant differences found among the treatment modalities for all except the Dental Health Component index. The pairwise comparison revealed suboptimal occlusal results with the MIE group. Good occlusal and esthetic treatment outcomes were achieved with the PME and NE groups.

Population-based incidence and clinico-radiological characteristics of tumefactive demyelination in Olmsted County, Minnesota, United States.

Tumefactive demyelination (TD) presents with large inflammatory lesions mimicking tumors or other space-occupying lesions. Limited epidemiological, clinical and radiological data exist for TD. We aimed to report the incidence rate, and clinical and radiological features of TD in Olmsted County, Minnesota. We retrospectively reviewed patients with central nervous system inflammatory demyelination-related diagnostic codes (January 1, 1998 to December 31, 2018) in the Rochester Epidemiology Project database, and adjusted incidence rates by age and sex to the 2010 US total population. We used the Expanded Disability Status Scale (EDSS) to assess outcomes (index attack and last follow-up). Of 792 multiple sclerosis (MS) patients, 15 (eight males, seven females) had tumefactive MS, representing 1.9% of the MS population. The median (range) age at attack onset was 34.2(2-61) years. Tumefactive lesion was the first clinical MS attack in 8/16 patients. Cerebrospinal fluid oligoclonal bands (OCBs) were present in 8/12 patients and 11/16 patients met the Barkhof criteria for dissemination in space. Most patients remained fully ambulatory (EDSS score ≤4 in 13/16 patients [81%]) after a median (range) follow-up duration of 10.5(1-20.5) years. Age-adjusted annual incidence rates were 0.46/100,000 (95% confidence interval [CI] 0.12-0.81) for female patients, 0.66/100,000 (95% CI 0.23-1.02) for male patients, and 0.56/100,000 [95% CI 0.28-0.83] overall. When age- and sex-adjusted to the 2010 US total population, the overall annual incidence rate was 0.57 (95% CI 0.28-0.84). Despite aggressive clinical presentation at disease onset, most patients remained fully ambulatory (EDSS score ≤4 in 13/16 patients) with a relapsing-remitting course. Although incidence is rare, TD should be suspected in patients presenting with subacutely progressive neurological deficits associated with magnetic resonance imaging findings of ring enhancement, apparent diffusion coefficient restriction, and OCB on spinal fluid analysis.

Remote, proactive, telephone based management of toxicity in outpatients during adjuvant or neoadjuvant chemotherapy for early stage breast cancer: pragmatic, cluster randomised trial

ObjectiveTo evaluate the effectiveness of remote proactive management of toxicities during chemotherapy for early stage breast cancer.DesignPragmatic, cluster randomised trial.Setting20 cancer centres in Ontario, Canada, allocated by covariate constrained randomisation...

Risk factors of early periprosthetic femoral fracture after total knee arthroplasty

BackgroundPeriprosthetic femoral fracture (PFF) is a serious complication after total knee arthroplasty (TKA). However, the risk factors of PFF in the early postoperative setting are not well documented. This study determines the risk factors of early PFF after primary TKA.MethodsThis study recruited 24 patients who had early PFF within postoperative 3 months and 96 control patients. Demographic data (age, gender, weight, height, body mass index, Deyo-Charlson comorbidity index, diagnosis, operated side, underlying diseases and history of steroid usage intraoperative outcomes), intraoperative outcomes (operative time, surgical approach, type and brand of the prosthesis), and radiographic outcomes (distal femoral width; DFW, prosthesis-distal femoral width ratio; PDFW ratio, anatomical lateral distal femoral angle; LDFA, the change of LDFA, femoral component flexion angle; FCFA and anterior femoral notching; AFN) were recorded and compared between groups. Details of PFF, including fracture pattern, preoperative deformity, and time to PFF were also documented.ResultsIn univariate analysis, the PFF group had significantly older, right side injury, rheumatoid, dyslipidemia, Parkinson patients than the control group (p < 0.05). No cruciate-retaining design was used in PFF group (p = 0.004). Differences between the prosthetic brand used were found in this study (p = 0.049). For radiographic outcomes, PFF group had significantly lower DFW but higher PDFW ratio and postoperative LDFA than the control group (p < 0.05). While the change of LDFA, FCFA and AFN were similar between groups. The fracture patterns were medial condylar (45.8%), lateral condylar (25.0%) and supracondylar fracture (29.2%). The mean overall time to PFF was 37.2 ± 20.6 days (range 8–87 days). Preoperative deformity was significantly different among the three patterns (p < 0.05). When performed multivariate analysis using the logistic regression model, age was only an independent risk factor for early PFF. The cut-off point of age was > = 75 years, with a sensitivity of 75.0% and specificity of 78.1%.ConclusionThis study determined that age was the independent risk factors for early PFF. However, further well-controlled studies with a larger sample size were needed to address this issue.

Impact on quality of life after vagus nerve and phrenic nerve guided systematic nodal dissection for non-small cell lung cancer patients: a prospective, single-arm clinical trial

BackgroundPatients with non-small cell lung cancer (NSCLC) suffer a decrease in quality of life (QOL) after receiving curative lobectomy and mediastinal lymph node dissection via video-assisted thoracoscopic surgery (VATS). We aimed to explore the preliminary influence of our modified approach called the duo-nerve-guided systematic nodal dissection (SND) on patients’ QOL.MethodsBetween October 2018 and March 2019, 21 patients were enrolled from the First Affiliated Hospital of Sun Yat-sen University and received curative lobectomy and duo-nerve-guided SND for clinical stage I to IIIA NSCLC. Participants’ QOL was evaluated by Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire before operation and at 1- and 3-month postoperatively.ResultsThe overall QOL scores at 1 month after surgery were significantly lower than those before surgery (116.13 vs. 126.63, P=0.001), while there was no significant difference in the overall QOL score between preoperative and 3 months after surgery. In particular, among the 5 subscales, physical well-being (PWB), functional well-being (FWB), and trial outcome index (TOI) significantly declined at 1 month after surgery. However, each subscale showed significant improvement at 3 months after operation compared with that at 1 month and basically returned to the level at baseline. In addition, there was a significant improvement in the emotional well-being (EWB) domain 3 months after surgery (23.00 vs. 18.00, P=0.001).ConclusionsAs evidenced by patients’ QOL at 3 months after receiving duo-nerve-guided SND being not significantly different from that at baseline, the improved SND procedure has positive effects on the fast recovery of NSCLC patients.

Systematic review and meta-analysis: the value of MRI chemical-shift imaging in the evaluation of bone quality in patients with osteoporosis.

Osteoporosis is a systemic skeletal disease with no obvious symptoms in its early stages. The decreases in bone density and bone mass are associated with the deterioration of bony microstructure in the body, due to a variety of reasons. The current assessment criteria for osteoporosis are still not perfect. MRI chemical-shift imaging shows potential to be a valuable technique in the bone quality assessment of osteoporotic patients. Randomized controlled studies on osteoporosis assessment were searched for in English-language databases, including PubMed, Web of Science, Embase, and The Cochrane Library. Inclusion criteria were: (I) literature focused on the assessment of osteoporosis by chemical displacement imaging; (II) studies evaluating the bone quality of osteoporosis; (III) studies with at least 15 samples; (IV) studies concerned with the evaluation of osteoporosis by chemical shift encoded magnetic resonance imaging (CSE-MRI); and (V) studies with outcome indexes for bone mineral density (BMD), body mass index (BMI), and bone marrow fat fraction (BMFF). The Jadad tool was used to evaluate the quality of the included studies, and the Review Manager v. 5.3 software was used to conduct the meta-analysis of the experimental data. A total of 7 suitable articles were selected. According to the results of the meta-analysis, for the osteoporosis group and normal group: BMD: MD =41.91 [95% confidence interval (CI): 40.15 to 43.66], Z=46.82 (P<0.00001); BMI: MD =-1.43 (95% CI: -2.02 to -0.84), Z=4.76 (P<0.00001); BMFF: MD =-18.34 (95% CI: -20.32 to -16.36), Z=18.15 (P<0.00001). MRI chemical-shift imaging can effectively measure BMD and bone mass, including in osteoporotic patients. However, the outcome indicators included in this study are not sufficient to assess the utility of MRI chemical shift imaging for evaluating bone mass in osteoporotic patients, and further expansion of the sample size and outcome indicators is needed.

Association Between Physician- and Patient-Reported Symptoms in Patients Treated With Definitive Radiation Therapy for Locally Advanced Lung Cancer in a Statewide Consortium

Little data have been reported about the patient experience during curative radiation therapy (RT) for lung cancer in routine clinical practice or how this relates to treatment toxicity as reported by clinicians. The purpose of this study was to compare clinician-reported adverse events (AEs) with patient-reported outcomes (PROs), including both specific symptoms/side effects, as well as overall quality of life (QoL) during and after definitive RT for locally advanced lung cancer (LALC) in a large statewide cohort. PROs were prospectively collected from patients treated with definitive RT for LALC at 24 institutions within the Michigan Radiation Oncology Quality Consortium between 2012 and 2018 using the Functional Assessment of Cancer Therapy trial outcome index. Physicians prospectively recorded AEs using the Common Terminology Criteria for Adverse Events, version 4.0. Patient-reported QoL changes from baseline were assessed during and after RT using the Functional Assessment of Cancer Therapy trial outcome index. Spearman correlation coefficients were calculated for AEs and similar PROs, and a multivariable analysis was used to assess associations with QoL. A total 1361 patients were included in the study, and 53% of respondents reported clinically meaningful declines in QoL at the end of RT. The correlation between clinician-reported esophagitis and patient-reported trouble swallowing was moderate (R=.67), but correlations between clinician-reported pneumonitis and patient-reported shortness of breath (R=.13) and cough (R=.09) were weak. Clinician-reported AEs were significantly associated with clinically meaningful declines in patient-reported QoL (R=- .46 for summary AE score). QoL was more strongly associated with fatigue (R=- .41) than lung-specific AEs. AEs are associated with clinically meaningful declines in QoL during and after RT for LALC, but associations between AEs and QoL are only modest. This highlights the importance of PRO data, and future research should assess whether earlier detection of PRO changes could allow for interventions that reduce the frequency of treatment-related clinically meaningful declines in QoL.

Optimal Antithrombotic Therapy after Implantation of a Transcatheter Aortic Valve: Warfarin, Aspirin, or Non-Vitamin K Antagonist Oral Anticoagulants? A Systematic Review and Meta-Analysis

Abstract Objective: Diverse antithrombotic strategies were applied to patients undergoing aortic valve replacement. However, the optimal therapeutic regimen for patients undergoing transcatheter aortic valve implantation/replacement (TAVI/TAVR) remains unclear. The purpose of this study was to compare the efficacy and safety of various antithrombotic therapies following TAVI/TAVR. Methods: Relevant clinical trials evaluating the effect of anticoagulation or antiplatelet regimens on patients after TAVI/TAVR from inception to September 2020 were identified using the PubMed, EMBASE, and the Cochrane Library databases. The inclusion criteria including (1) all patients underwent TAVI/TAVR; (2) the interventions were antithrombotic strategies that prevent the occurrence of thrombotic events in patients; (3) randomized controlled trials or prospective observational studies; and (4) investigation of at least 1 outcome with a follow-up period of ≥3 months. The exclusion criteria including (1) research content was identical or irrelevant to the purpose of the present study; (2) lack of the required outcome index or availability of fragmentary original information; and (3) the full text is not available. The major outcomes were all-cause mortality, thromboembolic complications, and bleeding events. The Cochrane Collaboration's tool and the Newcastle-Ottawa Scale were used for assessing the risk of bias in included studies. Results: Thirteen studies (3 randomized controlled trials and 10 non-randomized studies) were identified, with a total of 23,497 patients. Four studies compared direct oral anticoagulants (DOACs) with warfarin, 1 study compared aspirin with warfarin, 6 studies compared aspirin plus clopidogrel (dual antiplatelet therapy (DAPT)) with aspirin monotherapy, and 2 studies compared DAPT and aspirin monotherapy with warfarin concurrently. There were no significant differences found between the DOAC and warfarin groups regarding all-cause mortality (risk ratio (RR): 1.03; 95% confidence interval (CI): 0.65–1.64; P = 0.909; P het = 0.105), clinical adverse events (RR: 1.59; 95% CI: 0.99–2.58; P = 0.057; P het = 0.738), or bleeding events (RR: 0.93; 95% CI: 0.78–1.11; P = 0.437; P het = 0.338). The rates of all-cause mortality (RR: 0.71; 95% CI: 0.54–0.93; P = 0.012; P het = 0.845) and bleeding events (RR: 0.43; 95% CI: 0.22–0.83; P = 0.012; P het = 0.569) were lower in the aspirin group versus the warfarin group; however, there was no difference in the rate of clinical adverse events (RR: 0.38; 95% CI: 0.14–1.07; P = 0.068; P het = 0.593). The DAPT group had an advantage versus the aspirin group in all-cause mortality (RR: 0.89; 95% CI: 0.82–0.98; P = 0.013; P het = 0.299); however, the incidence of bleeding events (RR: 2.06; 95% CI: 1.39–3.07; P &lt; 0.001; P het = 0.001) exhibited an increasing trend. Notably, there was a slight decrease in the incidence of clinical adverse events (RR: 1.09; 95% CI: 0.94–1.26; P = 0.268; P het = 0.554). Conclusion: The present meta-analysis integrates the latest published results on antithrombotic strategies in patients after TAVI/TAVR. Aspirin showed a favorable risk-benefit profile versus warfarin, with lower rates of all-cause mortality and bleeding events. Although DAPT was also associated with a significantly lower rate of all-cause mortality, it was linked to a higher incidence of bleeding events. The DOACs did not show significant benefits compared with warfarin. Some certain limitations should be noted, such as different types of trails produce heterogeneity and finite inclusion of TAVI/TAVR patients increased selection bias.