Real-world Prospective Cohort Study Research Articles

Frailty and in-hospital mortality in older patients with acute exacerbation of COPD: A real-world prospective cohort study

BackgroundFew evidence exists for the effect of frailty on the patients admitted with an acute exacerbation of chronic obstructive pulmonary disease (AECOPD). ObjectiveWe explored the link between frailty and in-hospital death in AECOPD, and whether laboratory indicators mediate this association. MethodsThis was a real-world prospective cohort study including older patients with AECOPD, consisting of two cohorts: a training set (n = 1356) and a validation set (n = 478). The independent prognostic factors, including frail status, were determined by multivariate logistic regression analysis. The relationship between frailty and in-hospital mortality was estimated by multivariable Cox regression. A nomogram was developed to provide clinicians with a quantitative tool to predict the risk of in-hospital death. Mediation analyses for frailty and in-hospital death were conducted. ResultsThe training set included 1356 patients (aged 86.7 ± 6.6 years), and 25.0 % of them were frail. A nomogram model was created, including ten independent variables: age, sex, frailty, COPD grades, severity of exacerbation, mean arterial pressure (MAP), Charlson Comorbidity Index (CCI), Interleukin-6 (IL-6), albumin, and troponin T (TPN-T). The area under the receiver operating characteristic curve (ROCs) was 0.862 and 0.845 for the training set and validation set, respectively. Patients with frailty had a higher risk of in-hospital death than those without frailty (HR,1.83, 95%CI: 1.14, 2.94; p = 0.013). Furthermore, CRP and albumin mediated the associations between frailty and in-hospital death. ConclusionsFrailty may be an adverse prognostic factor for older patients admitted with AECOPD. CRP and albumin may be part of the immunoinflammatory mechanism between frailty and in-hospital death.

Safety, effectiveness, and usefulness of higher-dose tablets of generic pirfenidone in patients with IPF: a nationwide observational study in South Korea.

Pirfenidone is an antifibrotic medication approved for idiopathic pulmonary fibrosis (IPF). Fybro®, a generic version of pirfenidone developed in South Korea, gained approval and is available in 200mg and in higher-dose formulations of 400 and 600mg. This real-world prospective cohort study investigated the safety and effectiveness of Fybro®. A nationwide observational study was conducted in patients with IPF. Patients were followed up for 6 months, with a subset of patients being followed up for 12 months. Data on lung function and adverse events were collected. Patient adherence to fewer-pill (400 and/or 600mg tablets) and multiple-pill (200mg tablets) regimens were compared. Of the 359 enrolled patients, 352 received pirfenidone (Fybro®) at least once and were included in the analysis. The mean age was 69.0 years and 82.4% of patients were male. The median treatment duration was 186.0 days. A total of 253 patients (71.9%) experienced adverse events, with decreased appetite being the most common (16.5%). The adjusted decline rates in lung function were -1.5% and -2.2% predicted per year for forced vital capacity and diffusing capacity, respectively. No significant differences were observed based on the pirfenidone dose. For a daily intake of 1,200 or 1800mg of pirfenidone, a significantly longer duration of drug administration was observed with the fewer-pill regimen than with multiple-pill regimen. The safety and effectiveness of Fybro® observed in this real-world cohort study are consistent with previous studies. Using higher-strength tablets to reduce pill burden may improve medication adherence.

Efficacy and Safety of Methylphenidate and Atomoxetine in Medication-Naive Children with Attention-Deficit Hyperactivity Disorder in a Real-World Setting.

Methylphenidate (MPH) and atomoxetine (ATX) are the most common medications used to treat attention-deficit hyperactivity disorder (ADHD) in China; however, despite this, there is still a paucity of studies comparing their efficacy and safety, particularly for different characteristics. To address the lack of research, a real-world prospective cohort study was conducted to examine these properties of MPH and ATX, and to analyze correlations associated with age, sex, and different ADHD presentation. Children with ADHD meeting the eligibility criteria were recruited from January 2016 to July 2021. Study participants were treated with either MPH or ATX prescribed in the real-world setting, and were followed up for 26 weeks. Clinical efficacy response and adverse events (AEs) were recorded and measured. Subgroup analysis was performed to examine the efficacy response and AEs associated with age, sex, and different ADHD presentation. A total of 1050 children were recruited and 29 children were lost to follow-up. Of the 1021 children remaining, 533 were treated with MPH and 488 were treated with ATX. No significant differences were found in intelligence quotient, age, sex, or ADHD presentation between the MPH- and ATX-treated groups (p>0.05). The response rates were 84.6% in the MPH-treated group and 63.3% in the ATX-treated group. Subgroup analysis of response rate demonstrated that the treatment effect of MPH over ATX was consistent across subgroups except in the girls (odds ratio [OR] 2.09, 95% confidence interval [CI] 0.97-4.7) and the hyperactive/impulsive presentation group (OR 2.88, 95% CI 0.77-12.76). A total of 47.8% of children experienced AEs during MPH treatment, significantly lower than the rate of 56.8% during ATX treatment (p<0.05). The incidence of AEs in the MPH-treated group was higher in young children (<8years: 56.8%; 8-10 years: 47.2%) and lower in children over 10 years of age (29.0%). Overall, MPH was more effective and better tolerated than ATX. The incidence of AEs in children treated with MPH varied with age, and was higher in young children and lower in children over 10 years of age.

A Real-World Prospective Cohort Study of Patients With Newly Diagnosed Crohn's Disease Treated by a Multidisciplinary Team: 1-Year Outcomes.

Real-world data on outcomes of patients with newly diagnosed Crohn's disease (ndCD) is limited. We aimed to assess the achievement of corticosteroid-free clinical remission (CS-free CR) and other therapeutic targets 1 year after diagnosis in a cohort of patients with ndCD treated by a multidisciplinary team (MDT). A prospective observational cohort study was conducted on consecutive treatment-naïve adults with ndCD. Patients received management at the treating physician's discretion, along with a tailored nutritional plan provided by an inflammatory bowel disease (IBD)-oriented dietitian. Patients were guided and educated by an IBD nurse, with flexible communication access to the IBD team. Therapeutic targets were assessed at 1 year. Multivariable logistic regression was used to evaluate predictors of CS-free CR. Seventy-six patients (50% female) with a median age of 27 (22-39) years were eligible. Over 75% of patients were assessed by IBD-oriented dietitians and the IBD nurse. Within a median of 4.3 (2.5-6.7) months from diagnosis 60.5% initiated biologics (96% anti- tumor necrosis factor). Dietary intervention was applied to 77.6% of the cohort, either monotherapy (33.9%) or add-on (66.1%). At 1 year, 64.5% of patients achieved sustained CS-free CR, 56.6% biochemical remission, 55.8% endoscopic response, 44.2% endoscopic remission, 30.8% deep remission, and in 39.5% there was an improvement in health-related quality of life (HRQoL). Predictors for CS-free CR were uncomplicated phenotype (B1/P0), lower body mass index, and lower patient-reported outcome 2 scores at diagnosis. In a real-world setting at a tertiary medical center, a cohort of ndCD patients treated by an MDT resulted in favorable 1-year outcomes. Over 60% achieved CS-free CR, along with significant improvements in biomarkers and HRQoL.

Local injection of micro-dose anti-interleukin-17A antibody for palmoplantar pustulosis: A real-world study

Palmoplantar pustulosis (PPP), a chronic and stubborn skin disease, is mainly confined to the palms or/and soles, making it possible for localized use of therapeutic antibodies. In this real-world prospective cohort study, 8 patients with PPP received palms/soles injections of ixekizumab (0.8 mg in 0.1 ml) every 2 to 8 weeks due to the COVID-19 pandemic. The treatment endpoint was a 75% improvement from baseline in Palmoplantar Pustulosis/Psoriasis Area and Severity Index (PPPASI 75). At week 8, 75%, 50% and 12.5% of 8 patients reached PPPASI 50, PPPASI 75 and PPPASI 90. At week 12, 100%, 75% and 25% of 8 patients reached PPPASI 50, PPPASI 75 and PPPASI 90. This is the first study to evaluate the efficacy and safety of local injection of micro-dose ixekizumab for PPP in real clinical practice. A high proportion of patients rapidly achieved PPPASI 75, and maintained long-term efficacy with satisfactory safety.

A real-world prospective cohort study of immunogenicity and reactogenicity of ChAdOx1-S[recombinant] among patients with immune-mediated dermatological diseases

Immunogenicity and reactogenicity of COVID-19 vaccines have been established in various groups of immunosuppressed patients; however, studies involving patients with immune-mediated dermatological diseases (IMDDs) are scarce. To investigate the influence of IMDDs on the development of SARS-CoV-2-specific immunity and side-effects following ChAdOx1-S[recombinant] vaccination. This prospective cohort study included 127 patients with IMDDs and 97 participants without immune-mediated diseases who received ChAdOx1-S[recombinant]. SARS-CoV-2-specific immunity and side-effect profiles were assessed at 1 month postvaccination and compared between groups. Immunological (primary) outcomes were the percentages of participants who tested positive for neutralizing antibodies [seroconversion rate (SR)] and those who developed T-cell-mediated immunity demonstrated by an interferon-γ-releasing assay (IGRA) [positive IGRA rate (+IGRA)]. Reactogenicity-related (secondary) outcomes were the unsolicited adverse reactions and worsening of IMDD activity reflected by the uptitration of immunosuppressants during and within 1 month of vaccination. Overall, the SR for the IMDD group was similar to that of participants without immune-mediated conditions (75·6 vs. 84·5, P = 0·101), whereas + IGRA was lower (72·4 vs. 88·7, P = 0·003). Reactogenicity was similar between groups. No severe adverse reaction was reported. By stratifying the participants in the IMDD group according to individual disease, the immunogenicity of the vaccine was lowest in patients with autoimmune bullous diseases (AIBD) (SR 64·5%, +IGRA 62·9%) and highest in patients with psoriasis (SR 87·7%, +IGRA 80·7%). The reverse trend was found for vaccine-related reactions. Immunosuppressants were uptitrated in 15·8% of cases; 75% of these were patients with AIBD. Among participants with IMDDs, ChAdOx1-S[recombinant] showed good immunogenicity among patients with psoriasis, but demonstrated lower levels of immunogenicity for patients with AIBD. Some patients, especially patients with AIBD, should be closely monitored as they may require treatment escalation within 1 month postvaccination.

Robotic-assisted thoracic surgery following neoadjuvant chemoimmunotherapy in patients with stage III non-small cell lung cancer: A real-world prospective cohort study.

ObjectiveStage III non-small cell lung cancer (NSCLC) is a heterogeneous group of diseases. For this subset of patients, clinical management is still under debate and prognosis remains poor so far. In the present study, we aimed to evaluate the feasibility and safety of robotic-assisted thoracic surgery after neoadjuvant chemoimmunotherapy in stage III NSCLC.MethodsA real-world prospective cohort study was performed in a single-center setting from April 2021 to May 2022. Patients who were diagnosed with resectable or potentially resectable stage IIIA–B NSCLC and received neoadjuvant chemoimmunotherapy followed by robotic-assisted thoracic surgery were enrolled. Pathological response to neoadjuvant chemoimmunotherapy, treatment-related adverse events, and surgical outcomes of these patients were evaluated.ResultsA total of 44 patients who underwent robotic-assisted thoracic surgery after three doses of neoadjuvant chemoimmunotherapy were included in this study. Of these, 36 of 44 (81.8%) patients had a major pathological response, and 26 (59.1%) had a pathological complete response based on pathological examination of surgical specimen. Eight patients (18.2%) suffered grade 3 treatment-related adverse events, including neutropenia (n = 4), increased aminotransferases (n = 3), anemia (n = 1), and cutaneous capillary endothelial proliferation (n = 1). Robotic-assisted thoracic surgery was performed subsequently, and R0 resection was achieved in all patients. Only two (4.5%) patients required conversion to thoracotomy. Surgical complications occurred in five (11.4%) patients, including air leak (n = 3), chylothorax (n = 2), and surgical site infection (n = 1). There was no re-surgery or postoperative mortality within 90 days.ConclusionRobotic-assisted thoracic surgery following neoadjuvant chemoimmunotherapy showed good feasibility and safety in stage III NSCLC. It was not associated with unexpected perioperative morbidity or mortality and may be a promising therapeutic option in stage III NSCLC. These results need further confirmation by more large-scale clinical trials.

Effect of metabolic control on recurrent major adverse cardiovascular events and cardiovascular mortality in patients with premature coronary artery disease: Results of the Genetics of Atherosclerotic Disease study

Background and aimsCoronary artery disease (CAD) is the leading cause of death around the world, and its rate of presentation is increasing at young ages. Despite the evidence that secondary prevention in CAD reduces the risk of recurrent major adverse cardiovascular events (MACE), no studies have analyzed the composite control of blood pressure, lipids, and glucose control in premature CAD. Methods and resultsThis was a real-world prospective cohort study of patients with premature CAD. The composite control in blood pressure <140/80 mmHg, LDL-C <70 mg/dL, non-HDL-C <100 mg/dL, and Hemoglobin A1c <8% was considered as metabolic control. The primary endpoint was the occurrence of non-fatal and fatal MACE. The data included 1042 patients with premature CAD. The mean age of the patients was 54.1 ± 8.1 years, 18.5% were women, and had a median follow-up of 59.1 ± 11.8 months. Of them, 7% had non-fatal MACE, and 4% had a fatal MACE. Overall, 21.3% achieved metabolic control, and 3.0% did not achieve any target. Cox regression analysis showed that percutaneous coronary intervention (Hazzard ratio = 1.883 [95% CI, 1.131–3.136]), C-reactive protein (1.046 [1.020–1.073]), blood pressure >140/90 mmHg (2.686 [1.506–4.791]), fibrates (2.032 [1.160–3.562]), calcium channel blockers (2.082 [1.158–3.744]) had greater risk to present a recurrent non-fatal MACE; whereas familial history of premature CAD (2.419 [1.240–4.721]), heart failure (2.139 [1.032–4.433]), LDL-C >70 mg/dL (4.594 [1.401–15.069]), and diuretics (3.328 [1.677–6.605]) were associated with cardiovascular mortality. ConclusionsThe composite goal achievement in lipids, blood pressure and glucose, reduced the risk for recurrent MACE in 80%.

Impact of underrepresented populations on clinical outcomes of chemo-immunotherapy for extensive-stage small cell lung cancer: Real-world prospective cohort study.

8567 Background: Chemo-immunotherapy is the standard 1st-line therapy for patients with extensive-stage small cell lung cancer (ES-SCLC). Prospective data about underrepresented populations outside the clinical trial such as elderly or poor risk has not been revealed. Methods: We conducted a 32-hospitals prospective cohort study of consecutive patients with ES-SCLC who received carboplatin and etoposide with atezolizumab as 1st-line therapy between September 2019 and September 2020. The primary outcome was 6-months progression-free survival (PFS) probability of all patients. The secondary outcomes were overall survival (OS), PFS, time to treatment failure, objective response rate, safety, and differences in efficacy and safety depending on whether or not the key eligible study criteria of previous trials are met. Results: In total, 207 patients with ES-SCLC were analyzed. The median age was 72 years, and 64 patients (31%) were elderly (≥75 years). Most patients (89%) had a performance status (PS) of 0 or 1. As a result, 132 (64%) was categorized as eligible patients. The 6-months PFS probability of all patients was 38.8 % (95%CI:32.4-45.7%). Between eligible and ineligible patients, there was significant difference of patients who attained disease control (93% versus 77%, p = 0.002). Median PFS was significantly longer in eligible patients than ineligible patients (5.1 vs. 4.7 months; P =.03, HR 0.72 (95% CI 0.53–0.97)), and median OS was longer in eligible patients than ineligible patients, without any significant difference (15.8 vs. 13.1 months; P =.10, HR 0.73 (95% CI 0.51–1.07)). Survival analysis identified a PS score of 0-1 (HR: 0.60, 95% CI: 0.39-0.97, p = 0.03) as a significant predictor of better PFS, while PS score of 0-1 (HR: 0.51, 95% CI: 0.31-0.89, p = 0.01) and younger patients ( &lt; 75 years) (HR: 0.66, 95% CI: 0.45-0.97, p = 0.03) as significant-good predictor of OS. The rate of severe AEs was higher in ineligible patients than in eligible (39% vs. 27%, respectively; p = 0.07), although the difference was not significant. Older age was significantly associated with severe AEs (p = 0.049). Conclusions: The real-world efficacy of chemo-immunotherapy for ES-SCLC was similar to that of pivotal clinical trials. However, trial-ineligible patients with ES-SCLC had poor treatment outcome and the higher rates of severe adverse events in this prospective cohort study. Our study suggests that positive results among the trial eligible patients may not translate to ineligible patients. Clinical trial information: UMIN000038064.

Effective and Safe Treatment of Psoriatic Disease with the Anti-IL-23p19 Biologic Tildrakizumab: Results of a Real-World Prospective Cohort Study in Nonselected Patients

Background: After registration of drugs, evidence about efficacy and safety is solely based on data of phase 2/3 clinical trial programs. A major drawback is the selection of patients following inclusion/exclusion criteria. There is a considerable time and knowledge gap between study and registry data that evaluate real-world evidence (RWE). To close this gap, prospective cohort data are helpful. Objectives: Soon after tildrakizumab, an interleukin 23p19-inhibitor, was registered for moderate-to-severe plaque psoriasis, a prospective single-center cohort study was established to evaluate efficacy and safety of tildrakizumab in daily practice. Methods: Following approval of tildrakizumab, patients with moderate-to-severe plaque psoriasis eligible for systemic treatment were included into the Kiel Tildra Cohort (KTC) and followed using routine assessments of efficacy, psoriasis area and severity index (PASI), body surface area (BSA), dermatology life quality index (DLQI), itch (visual analog scale), and safety. Data of the KTC were compared to the respective phase 3 clinical trials. Results: The KTC included 150 patients differing substantially from those in the trial program. There was a high rate of previous systemic (87.3%) and biologic (31.8%) therapy and of comorbidity in the KTC as compared to the phase 3 studies. Due to the best practice approach, baseline PASI was lower in the KTC, but DLQI was similar in both groups. At the time of this analysis, 126 patients completed week 28, 92 patients week 52, and 58 patients week 76, respectively. There was a constant improvement in PASI, BSA, DLQI, and itch from baseline until week 76. There was no clinically meaningful laboratory abnormality. Conclusions: Patients treated in routine practice with tildrakizumab differed substantially from the phase 3 studies. Despite systemic pre-treatment and increased comorbidity, tildrakizumab showed comparable efficacy and safety in the KTC. Prospective cohort studies are a suitable tool to generate RWE before registry data become available.

Protocol for the Acute Myocardial Infarction Study in Northeastern China (AMINoC): a real-world prospective cohort study.

IntroductionAcute myocardial infarction (AMI) has become one of the major causes of mortality and morbidity in China. However, little is known about the characteristics, medical care and outcomes of patients with AMI in Northeastern China. The Acute Myocardial Infarction Study in Northeastern China (AMINoC) is aimed at obtaining timely real-world knowledge in terms of characteristics, clinical care and outcomes of patients with AMI and at providing care-quality improvement efforts in Northeastern China.Methods and analysisThe AMINoC is a real-world, prospective, multicentre cohort study. The study selected 20 hospitals using stratified cluster sampling from different levels of hospitals among nine districts throughout Jilin Province. Hospitalised patients with a primary diagnosis of AMI in each site are consecutively enrolled for 1 year. Demographic characteristics, clinical data, treatments, outcomes and cost are collected by local investigators. Patient follow-up after discharge is planned for up to 2 years.Ethics and disseminationThe protocol has been approved by the ethics committee at the Second Hospital of Jilin University. The findings of this study will be published in peer-reviewed journals and medical conferences.Trial registration NCT04451967.

A real-world prospective cohort study to examine the relationship between simple physical functioning tests and complications following abdominal surgery

BACKGROUND: The relationship between physical function and the development of complications in people after abdominal surgery is not well known. The objective of this study was to prospectively examine the relationship between simple physical functioning tests and complications following abdominal surgery. METHODS: Participants were recruited from an elective surgery waiting list. The following variables were measured pre-surgery; functional capacity (Six Minute Walk Test, 30 Second Sit to Stand Test), grip strength (hand dynamometer), self-report physical activity [International Physical Activity Questionnaire, (IPAQ)]. At 30 and 60 days post-operatively IPAQ and self-reported recovery were collected by telephone. Data related to complications and length of stay was extracted from the medical chart. RESULTS: Forty-nine participants (25M/18F) were recruited with a mean (SD) age of 59.5 (14.7) years. The complication rate was 41.9% (n = 18). Factors which differed between the complications and no complications groups were; longer operating time (p = 0.05),&gt;2 co-morbidities (p = 0.033), body mass index &gt;30 (p = 0.005), lower activity levels (p = 0.02), VO2 Peak (p = 0.017) and 6-minute walk distance (p = 0.019). There was an increased length of stay (p &lt; 0.001) and sedentary time (p = 0.007) in the complications group. Activity levels reduced in the whole group (p &lt; 0.001) even though self-report physical activity and recovery were high. CONCLUSION: A number of potentially modifiable physical functioning factors differed in the complication versus no complication groups. Future studies should evaluate whether optimizing physical functioning pre-operatively could alter complication rates and recovery in patients undergoing abdominal surgery.

PMS16 Longitudinal Analyses of Health-Related Quality of Life and Daily Activities Function Among HIP Fracture Population: A Real-World Prospective Cohort Study

PMS16 Longitudinal Analyses of Health-Related Quality of Life and Daily Activities Function Among HIP Fracture Population: A Real-World Prospective Cohort Study

Clinical and Patient-Reported Outcomes of Direct-Acting Antivirals for the Treatment of Chronic Hepatitis C Among Patients on Opioid Agonist Treatment: A Real-world Prospective Cohort Study.

BackgroundPatient-reported outcomes (PROs) can help to reduce uncertainties about hepatitis C virus (HCV) treatment with direct-acting antivirals (DAAs) among people who inject drugs and increase treatment uptake in this high-risk group. Besides clinical data, this study analyzed for the first time PROs in a real-world sample of patients on opioid agonist treatment (OAT) and HCV treatment with DAAs.MethodsHCV treatment data including virological response, adherence, safety, and PROs of 328 German patients on OAT were analyzed in a pragmatic prospective cohort study conducted from 2016 to 2018. Clinical effectiveness was defined as sustained virological response (SVR) at week 12 after end of treatment and calculated in per-protocol (PP) and intention-to-treat (ITT) analyses. Changes over time in PROs on health-related quality of life, physical and mental health, functioning, medication tolerability, fatigue, concentration, and memory were analyzed by repeated-measures analyses of variances (ANOVAs).ResultsWe found high adherence and treatment completion rates, a low number of mainly mild adverse events, and high SVR rates (PP: 97.5% [n = 285]; ITT: 84.5% [n = 328]). Missing SVR data in the ITT sample were mainly caused by patients lost to follow-up after treatment completion. Most PROs showed statistically significant but modest improvements over time, with more pronounced improvements in highly impaired patients.ConclusionsThis real-world study confirms that DAA treatment among OAT patients is feasible, safe, and effective. PROs show that all patients, but particularly those with higher somatic, mental, and social burden, benefit from DAA treatment.

Evaluating the impact of dose reductions and delays on progression-free survival in women with ovarian cancer treated with either three-weekly or dose-dense carboplatin and paclitaxel regimens in the national prospective OPAL cohort study

ObjectivesTo determine the impact of chemotherapy dose reductions and dose delays on progression-free survival (PFS) in women with ovarian cancer receiving first line chemotherapy in a real world prospective cohort study. MethodsPatients with newly diagnosed epithelial ovarian (or peritoneal, fallopian tube) cancer enrolled in a national Australian prospective study, OPAL, who commenced three-weekly carboplatin (AUC 5 or 6) and paclitaxel 175 mg/m2 (CP) or carboplatin (AUC 5 or 6) and dose-dense weekly paclitaxel 80 mg/m2 (DD-CP) were eligible. Primary endpoint was PFS. Results634 evaluable patients, 309 commenced CP and 325 DD-CP. Patient's age was similar in the two groups (median 62 years, range 21–79). All planned chemotherapy doses were completed by 66% vs 40% (p < 0.001) in the CP and DD-CP groups respectively. There was at least one treatment delay in 28% vs 58% (p < 0.001) in the CP and DD-CP groups, respectively, and 29% vs 49% (p < 0.001), respectively, required at least a 15% dose reduction for either carboplatin or paclitaxel. Median PFS was 29.2 [22.9, 43.8] and 21.5 [19.4, 23.1] months in the CP and DD-CP groups respectively. Adjusting for age, histology and FIGO stage PFS did not differ between treatment groups. Median PFS was similar in patients irrespective of dose reduction or dose delay. ConclusionPatients receiving DD-CP required more dose reductions and delays due to haematological toxicities and lower completion rates than CP without significant difference in median PFS between CP and DD-CP. Median PFS was similar in patients irrespective of dose reduction or dose delay.

Effects of teriparatide versus percutaneous vertebroplasty on pain relief, quality of life and cost-effectiveness in postmenopausal females with acute osteoporotic vertebral compression fracture: A prospective cohort study.

Osteoporotic vertebral compression fracture (OVCF) is a common disease in senior patients. Conservative treatments (usual care) and percutaneous vertebroplasty (PVP) are typically applied to treat OVCFs; however, their efficacies are not fully satisfactory. While Teriparatide (TPTD) is effective in both anti-osteoporosis and bone healing, whether TPTD could be applied as a conservative treatment for acute OVCFs remains unclear. This investigation represents a real-world prospective cohort study, where 60 postmenopausal women (≥55 years old) with acute OVCFs were equally assigned to a TPTD conservative group or PVP (plus alendronate) group based on the patient's choice. TPTD (20 μg, s.c., once daily) or alendronate (70 mg, p.o., once weekly) were administrated together with 0.6 mg Caltrate and 500 iu Vitamin D3 per day. A health survey (SF-36) was conducted at 0-, 1- and 3-months post-treatment. Back pain and the Oswestry Disability Index (ODI) were measured at 0-week, 1-week, 1-month and 3-months after treatment, while the direct medical cost was analyzed at the end of the third month. Both treatments with TPTD and PVP significantly and similarly improved the patients' health quality, with reduced visual analogue and ODI scores at the end of the first and third months. PVP was more effective in reducing pain at the early time point (1 week, p < 0.05). 24 of 27 patients who were rescanned with magnetic resonance imaging in the TPTD group showed bone healing. The mid-vertebral height was increased by PVP (p < 0.05) but not by TPTD. The cost of TPTD treatment was 21,868.61 ± 167.05 RMB per capita, while the cost for PVP treatment was 33,265.95 ± 1491.11 RMB per capita (p < 0.05). TPTD conservative treatment obtained similar therapeutic effects but cost less than PVP in terms of treating acute OVCF.

Impact of depression and/or anxiety on patients with percutaneous coronary interventions after acute coronary syndrome: a protocol for a real-world prospective cohort study

IntroductionAcute coronary syndrome (ACS) is one of the leading causes of death. Depression and/or anxiety after ACS is common. Studies from developed countries have reported that the occurrence of anxiety...

Does everyone who quit smoking gain weight? A real-world prospective cohort study.

ABSTRACTObjective:To evaluate weight changes after 12 months of biochemically confirmed smoking abstinence, comparing patients who lost weight or maintained their baseline weight with those who gained weight. Methods:This was a real-world prospective cohort study conducted at the Outpatient Smoking Cessation Clinic of São Lucas Hospital, in the city of Porto Alegre, Brazil, between 2010 and 2016. The patients evaluated received intensive smoking cessation counseling, focused especially on weight issues, together with pharmacotherapy, and were followed for 12 months. The baseline and final weights were measured. Continuous abstinence was confirmed by determining the concentration of exhaled carbon monoxide (eCO). Results:Of a total of 348 patients evaluated, 161 (46.2%) achieved continuous abstinence (eCO < 10 ppm) over the 12-month follow-up period. Of those 161 patients, 104 (64.6%) maintained their initial weight or had a weight change of no more than 5% in relation to their baseline weight, whereas the remaining 57 (35.4%) had a weight gain of more than 5%, 18 of those patients showing a > 10% increase over their baseline weight. The number needed to harm (i.e., the number of patients required in order to detect one patient with a weight increase) was calculated to be 3.6 (95% CI: 2.8-5.4). Conclusions:Weight gain is not necessarily associated with smoking cessation, and smokers who are motivated to quit should be informed of that fact. This information could also be useful for addressing smokers who are still undecided because of possibility of weight gain.

Clinical course and perinatal transmission of chronic hepatitis B during pregnancy: A real-world prospective cohort study

To determine the clinical course and perinatal transmission of chronic hepatitis B during pregnancy in a real life setting. A total of 221 singleton pregnant women with detectable HBV-DNA levels (≥103 copies/mL) were enrolled during January 2011 to June 2015. Forty-three high viraemic patients (≥106 copies/mL) received telbivudine in the 2nd or 3rd trimester according to their intention, while 89 high viraemic and 79 low viraemic (≥103 and <106 copies/mL) patients were the control cohorts. Primary endpoint was the pregnancy outcomes and secondary endpoint the perinatal transmission including intrauterine infection, immunoprophylaxis failure and occult infection. In all, 209 patients completed pregnancy with 209 infants, while 2 in telbivudine-treated cohort had unexplained late stillbirths. Twenty-nine (70.7%) of telbivudine-treated patients and 3 (3.4%) of untreated high viraemic controls achieved undetectable HBV-DNA levels prior delivery. At 7 months postpartum, immunoprophylaxis failure was significantly lower (2.4%) in telbivudine-treated cohort, compared with 16.9% and 10.1% in untreated high and low viraemic cohorts, respectively. Low viraemic patients may also need antiviral therapy since they bear moderate risk for perinatal transmission of HBV. However, more multicenter, large-scale studies are required before antepartum antiviral therapy is routinely recommended in patients with detectable viral loads.