Is patient self-reporting more accurate than clinician reporting of symptoms for predicting survival in patients with cancer? Meta-analysis of 30 closed EORTC randomized controlled trials

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9597-9597
Author(s):  
A. Bottomley ◽  
C. Coens ◽  
M. King ◽  
D. Osoba ◽  
M. J. Taphoorn ◽  
...  

9597 Background: This study investigated whether patient self-reporting of symptoms improved prediction of survival as compared to clinician reporting or whether it provided an additive value when taken together with clinician assessment of the same symptoms. Methods: Patients with advanced cancer from 30 European Organisation for Research and Treatment of Cancer (EORTC) Randomized Controlled Trials were included in this retrospective pooled analysis. Clinician [Common Toxicity Criteria (CTC)] and patient (EORTC QLQ-C30) symptom assessment were reported at entry into the study. Data were obtained for six symptoms: pain, fatigue, vomiting, nausea, diarrhea and constipation. The prognostic accuracy for survival was assessed by modeling the contrast in reporting using the Harrell's discrimination c-index (c). Results: Data were available from patient and clinician assessment for pain [number of trials (t) =8, number of patients (n) =1214], fatigue [t=5, n=1237], vomiting [t=5, n=824], nausea [t=6, n=1393], diarrhea [t=6, n=815] and constipation [t=4, n=751]. Fatigue (c=0.59 vs 0.55, p<.01) and constipation (c=0.57 vs 0.52, p=0.03) as reported by patients (vs clinicians) were significantly higher in predicting survival. Patient reported pain (c=0.59 vs 0.58, p=0.17), nausea (c=0.54 vs 0.52, p=0.51), vomiting (c=0.55 vs 0.52, p=0.21) and diarrhea (c=0.51 vs 0.52, p=0.49) did not predict survival any more accurately than clinician assessment. Patient and clinician assessment combined (vs clinicians alone) improved the prognostic accuracy for fatigue (c=0.61 vs 0.55, p=0.01), pain (c=0.60 vs 0.58, p<0.01), nausea (c=0.54 vs 0.52, p=0.04), vomiting (c=0.56 vs 0.52, p=0.04) and constipation (c=0.5 vs 0.52, p=0.01), but not for diarrhea (c=0.52 vs 0.52, p=0.44). Conclusions: Our results suggest that patients’ ratings of their own fatigue and constipation have more prognostic value than clinicians’ ratings of these symptoms. Further, the prognostic value of clinicians's ratings can be improved by combining them with patients’ assessments for the symptoms pain, fatigue, constipation, nausea and vomiting. No significant financial relationships to disclose.

2019 ◽  
Vol 161 (3) ◽  
pp. 412-418
Author(s):  
Peter M. Debbaneh ◽  
Anna K. Bareiss ◽  
Sarah K. Wise ◽  
Edward D. McCoul

Objective Combination therapy with intranasal azelastine and fluticasone propionate is an option for treatment of allergic rhinitis. This systematic review and meta-analysis examines existing literature to determine efficacy in treating allergic rhinitis compared to monotherapy. Data Sources The PubMed, EMBASE, Cochrane, and MEDLINE databases were systematically searched for randomized controlled trials using AzeFlu nasal spray. Review Methods Randomized, controlled trials that reported symptom relief of allergic rhinitis in males and females of all ages were included. Results were reported in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standard. Results Systematic review identified 8 articles suitable for review. The risk of bias was generally low. All studies exhibited a greater decrease in patient-reported symptom scores in patients treated with combination therapy compared to monotherapy or placebo. Meta-analysis revealed superiority of combination therapy in reducing Total Nasal Symptom Score compared to placebo (mean change from baseline: −2.41; 95% confidence interval [CI], −2.82 to −1.99; P < .001; I 2 = 60%), azelastine (mean change from baseline: −1.40; 95% CI, −1.82 to −0.98; P < .001; I 2 = 0%), and fluticasone (mean change from baseline: −0.74; 95% CI, −1.17 to −0.31; P < .001; I 2 = 12%). Conclusion Current evidence supports both efficacy and superiority of combination intranasal azelastine and fluticasone in reducing patient-reported symptom scores in patients with allergic rhinitis. Combination nasal spray should be considered as second-line therapy in patients with allergic rhinitis that is not controlled with monotherapy.


2020 ◽  
Author(s):  
Ying Zhang ◽  
Yuting Wang ◽  
Youfa Zhou ◽  
Jian Li ◽  
Haiyan Zhou

Abstract Background: Despite widely use of recombinant factor VIIa (rFVIIa) for bleeding in patients without haemophilia, its efficiency and safety remain unclear. Therefore, we carried out a meta-analysis on this topic. Methods: We searched Cochrane Library, Web of Science, PubMed and Embase, from January 2008 to July 2019 for randomized controlled trials on the topic. The results of this work are synthesized and reported in accordance with the PRISMA statement. Results: Twelve trials met our inclusion criteria. rFVIIa over 200ug/kg reduced red blood cell (RBC) transfusions within 24 h by 232.34ml (95% confidence interval [CI]; -410.31 to -54.37). rFVIIa did not significantly reduce 30-day mortality (relative risk [RR], 1.00; 95%CI, 0.82-1.21), total thromboembolic events (RR, 1.13; 95%CI, 0.94-1.36), myocardial infarction (RR, 1.37; 95%CI, 0.92-2.05), deep vein thrombosis (RR, 0.83; 95%CI, 0.52–1.33), ICU staying (RR, 0.40; 95%CI, -1.28 to 2.07) and number of patients transfused RBC (RR, 0.94; 95%CI, 0.83-1.08). However, rFVIIa may increase the incidence of arterial thrombotic events (RR, 1.38; 95%CI, 1.08–1.77). Conclusion: rFVIIa over 200ug/kg reduced RBC transfusions for bleeding in patients without haemophilia. However, it may increase the risk of arterial thrombotic events.


2021 ◽  
pp. 106002802110412
Author(s):  
Waranee Bunchuailua ◽  
Nathapol Samprasit ◽  
Surachai Kotirum ◽  
Nattiya Kapol

Background Depression is a substantial health burden. Pharmacist activities may help improve health outcomes of patients with depression when comparing to current practice with no pharmacist-involved intervention. Objective To systematically review and analyze randomized controlled trials assessing the impact of pharmacist services on patients with depression compared to usual care using a meta-analysis approach Methods Four international and 3 domestic electronic databases were systematically searched. Data from database inception to December 2019 were included. Studies were selected using predefined inclusion criteria, and quality was assessed using the risk-of-bias criteria. Pooled estimation was analyzed to report the relative risk (RR) and standard mean difference (SMD). The meta-analysis used the random-effect model when heterogeneity was observed between studies. Results A total of 12 eligible studies with 2133 patients with depression were included in the analysis. The relevant pharmacist interventions included medication therapy management, adherence counseling, and educational advice about depression and antidepressants. Pooled data in the meta-analysis showed a significantly increased number of patients with good adherence (RR = 1.39; 95% CI = 1.11 to 1.75) and improved medication adherence score (SMD = 0.32; 95% CI = 0.07 to 0.56) associated with pharmacist activities compared to usual care. No significant differences were detected in clinical rating scales (SMD = −0.03; 95% CI = −0.16 to 0.10) and quality of life (SMD = 0.10; 95% CI = −0.04 to 0.25) Conclusion and Relevance This review suggests that the role of pharmacists in patients with depression has a positive impact on medication adherence.


2020 ◽  
Vol 26 (25) ◽  
pp. 3026-3038 ◽  
Author(s):  
Wuttapon Sadaeng ◽  
Katalin Márta ◽  
Péter Mátrai ◽  
Péter Hegyi ◽  
Barbara Tóth ◽  
...  

Herpes zoster (HZ) causes considerable pain and distress, and &#947;-Aminobutyric acid (GABA) and its derivatives are assumed to control this, but the available data are inconsistent. This meta-analysis and systematic review aimed to assess the effectiveness of GABA derivatives in the prevention of acute herpetic pain. The metaanalysis was conducted following the PRISMA guidelines using PICO format, registered in PROSPERO number CRD42018095758. PubMed, Web of Science, Ovid, Scopus, and EMBASE databases were searched. Records were included if they were randomized controlled trials of patients undergoing HZ infection, investigating the effect of GABA derivatives versus placebo in the treatment of HZ pain. Eligible trials were evaluated for the risk of bias. Then data were extracted and analysed. The number of patients with observed presence of pain after treatment was used to calculate odds ratio in a random effect model with the DerSimonian-Laird estimator. The I2 statistic was analysed for heterogeneity. The potential risk of bias was measured using Egger’s regression test. The meta-analysis included three randomized controlled trials with a total of 297 patients. The incidence of acute HZ pain events for GABA group was significantly lower compared to placebo group,18/148 vs 44/149, respectively (OR = 0.36; 95% CI = 0.14 to 0.93; Z = 2.11; P = 0.035), Egger’s test yielded P = 0.308. In conclusion, the present meta-analysis demonstrates that GABA derivatives reduce the incidence of acute herpetic pain. However, additional, well-designed randomized clinical trials are needed to determine their dose- and time-dependency regarding this symptom.


2020 ◽  
Author(s):  
Wu Ye ◽  
Xia Wu ◽  
Xue Zheng ◽  
Yuping Gong

Abstract Background The meta-analysis compared the efficacy and safety of momelotinib, ruxolitinib and pacitinib in patients with myeloproliferative neoplasms(MPN), which includes essential thrombocythemia, polycythemia vera and primary myelofibrosis. Methods We searched multiple databases and collected relevant studies before Dec. 20,2019. According to predefined criteria, we included eight qualified phase 3 randomized controlled trials with 2125 patients in the meta-analysis. Statistical analysis used StataMP14 and Indirect Treatment Comparisons software. The meta-analysis is registered with PROSPERO, number CRD42020164271. Results The relative risk (95%confidence interval) of momelotinib vs ruxolitinib, ruxolitinib vs pacritinib and momelotinib vs pacritinib by indirect-comparison are as follows: The RR(95%CI) for ≥ 35% reduction in spleen volume from baseline at week 24/32 as determined by magnetic resonance imaging or computed tomography were 0.93(95%CI0.69-1.25), 10.87(95%CI2.52-46.79) and 10.09(95%CI2.27- 44.74); The RR(95%CI) for ≥ 50% reduction in total symptom score from baseline at week 24–32 assessed using the modified Myelofibrosis Symptom Assessment Form were 1.61(95%CI0.25-10.15), 4.40(95%CI2.13-9.09) and 7.12 (95%CI0.91-55.41); The RR(95%CI) for the risk of anemia were 0.60(95%CI0.20-1.85), 0.80(95%CI0.56-1.14) and 0.48 (95%CI0.15-1.56); The RR(95%CI) for thrombocytopenia were 0.69(95%CI0.50-0.96), 1.33(95%CI0.77-2.30) and 0.92(95%CI0.48-1.74); The RR (95%CI) for the risk of fatigue were 1.07(95%CI0.71-1.59), 0.82(95%CI0.49-1.37) and 0.88(95%CI0.46-1.68); The RR(95%CI) for the risk of diarrhea were 1.32(95%CI0.58-3.01), 0.11(95%CI0.03-0.46) and 0.39(95%CI0.15-1.02); The RR(95%CI) for abdominal pain were 0.95(95%CI0.61-1.48), 0.83(95%CI0.30-2.25) and 0.78(95%CI0.26-2.35). The RR(95CI) for the improvement of transfusion-independent of pacritinib vs ruxolitinib was 6.36 (95%CI0.79-50.98). Conclusions Excluding the improvement of transfusion-independent and the risk of thrombocytopenia, pacritinib had relatively poorer efficacy and higher risk of adverse events compared with momelotinib or ruxolitinib. Momelotinib had similar or better efficacy and similar or lower risk of adverse events than ruxolitinib while excluding the risk of diarrhea. In general, momelotinib has the best potential therapeutic value in patients with MPN among the three drugs, but further clinical studies are needed to prove it.


2020 ◽  
Vol 13 (3) ◽  
pp. 268-273 ◽  
Author(s):  
Ji-Sun Kim ◽  
Sun Hong Kim ◽  
Hyesook Lee ◽  
Byung Guk Kim ◽  
Se Hwan Hwang

Objectives. Although osteotomy is an important part of rhinoplasty, it is known to be closely related to postoperative eyelid edema and ecchymosis. We aimed to evaluate the effects of periosteal elevation prior to osteotomy on eyelid edema and ecchymosis.Methods. Two authors reviewed studies in the Medline, Scopus, and Cochrane databases published through May 2019. Randomized controlled trials comparing periosteal elevation (subperiosteal tunneling) with periosteal preservation that reported eyelid edema or ecchymosis or subconjunctival hemorrhage as outcomes of interest were included. From each study, the baseline characteristics of the study subjects, the quality of the study, the number of patients in the treatment and control groups, and outcomes were extracted.Results. Data for meta-analysis were identified in six studies with a total of 208 patients. Eyelid ecchymosis and edema within 3 days postoperatively were significantly more common in the periosteal elevation group than in the preservation group, although such an association was not found for edema on postoperative day 7 (standardized mean difference [SMD], 0.21; 95% confidence interval [CI], –0.09 to 0.50; I<sup>2</sup> =0%). There was no significant difference in subconjunctival hemorrhage on day 1 (SMD, 0.31; 95% CI, –0.09 to 0.72; I<sup>2</sup> =0%).Conclusion. Periosteal preservation during lateral osteotomy may reduce eyelid edema and ecchymosis compared to periosteal elevation. Further studies with rigorous research methods should be carried out to determine the effectiveness of different techniques in lateral osteotomy.


2014 ◽  
Vol 94 (12) ◽  
pp. 1697-1708 ◽  
Author(s):  
Ron Clijsen ◽  
Janine Fuchs ◽  
Jan Taeymans

Background and Purpose This systematic review and meta-analysis was accomplished to determine whether exercise therapy is an effective intervention to reduce pain and patient-reported measures of activity limitations and participation restrictions (PRMALP) in patients with patellofemoral pain. Data Sources and Study Selection Randomized controlled trials in English and German languages published in the MEDLINE, Physiotherapy Evidence Database (PEDro), International Clinical Trials Registry Platform, and Cochrane databases were searched. Eligibility was assessed in 2 stages. The methodological quality of the studies was rated using the PEDro scale. Data were pooled using random-effects meta-analysis, allowing for variability among studies. For clinical use, overall estimates were re-expressed in the original visual analog scale scores. Significance was set at 5%. Data Extraction and Data Synthesis Fifteen studies, with a total of 748 participants, were included and pooled for the meta-analysis. Six studies compared the effect of exercise therapy with a control group receiving neither exercise therapy nor another intervention. Four studies compared the effect of exercise therapy versus additive therapy, and 5 studies compared different exercise interventions. In both comparisons, exercise therapy resulted in strong pain reduction and improvement of PRMALP effects. Significant short-term effects (≤12 weeks) of exercise therapy were found for pain and PRMALP, whereas long-term effects (≥26 weeks) were observed for PRMALP only. Limitations and Conclusion The 15 studies included in this analysis were of variable quality. Large-scale, high-quality randomized controlled trials are needed to further the evaluation of the possible effects of different exercise therapy modalities on patellofemoral pain. This meta-analysis presents evidence that exercise therapy has a strong pain-reducing effect and decreases PRMALP in patients with patellofemoral pain. However, the question of which exercise modality yields the strongest reducing effect on pain and PRMALP remains unanswered.


2019 ◽  
Author(s):  
Bzeizi Khalid ◽  
Smith Richard ◽  
Benmousa Ali ◽  
Dama Madhukar M.V.SC ◽  
Aba-Alkhail Faisal ◽  
...  

ABSTRACTBackgroundRisk of nephrotoxicity in liver transplant patients on calcineurin inhibitors (CnIs) is a concern. Several controlled trials reported benefit of Everolimus (EVR) in minimizing this risk when combined with a reduced CnIs dose.ObjectiveTo systematically review the efficacy and safety of EVR, alone or with reduced CnI dose, as compared to CnI alone post liver transplantation.MethodsWe searched MEDLINE, Scopus and the Cochrane Library for randomized controlled trials (RCTs) comparing EVR and CnI based regimens post liver transplanation. Assessment of studies and data extraction was undertaken independently.ResultsEight studies were selected describing 769 patients. Cockcroft-Gault GFR (CG-GFR) was significantly higher at one (p=0.05), 3 & 5 years (p=0.030) in patients receiving EVR as compared to those receiving CnI therapy. The composite end point of efficacy failure was similar between the two arms after 1, 3 & 5 years of study. Higher number of patients discontinued EVR due to adverse effects in one year, however no difference was noted after 3 & 5 years. A higher rates of proteinuria, peripheral edema and incisional hernia were noted in patients on EVR.ConclusionThe analysis confirms non-inferiority of EVR and reduced CnI combination. Patients on the combination regimen had better renal function compared to standard CnI therapy.


2019 ◽  
Vol 18 (1) ◽  
Author(s):  
Xiaoyu Liu ◽  
Wei Zhang ◽  
Ming Zhao ◽  
Guowei Jia ◽  
Rongguo Sun

Abstract Background Influences of atorvastatin on atherosclerosis and glycemic metabolism may be related to its potential impact on circulating adiponectin, an adipocyte that exerts anti-inflammatory, ant-atherosclerotic, and anti-oxidative effects. However, results of previous randomized controlled trials (RCTs) were not consistent. We performed a meta-analysis of RCTs to systematic evaluate the influence of atorvastatin on circulating adiponectin. Methods Relevant studies were identified via search of electronic databases of PubMed, Embase, and Cochrane’s Library. A random-effect model was applied to pool the results via incorporating the potential heterogeneity. Predefined meta-regression and subgroup analyses were used to evaluate the influences of study characteristics on the outcome. Results Fourteen datasets from ten RCTs including 931 patients were included. Pooled results showed that atorvastatin did not significantly affect circulating adiponectin as compared with controls (weighed mean difference = − 0.27 μg/mL, 95% confidence interval: − 0.89 to 0.35 μg/mL, p = 0.39). Results of univariate meta-regression analyses showed that study characteristics including number of patients, mean age, proportion of male patients, body mass index, dose of atorvastatin, or treatment duration did not significantly affect the outcome (p all > 0.05). Moreover, subgroup analyses showed that atorvastatin did not significantly affect circulating adiponectin in studies stratified according to these study characteristics (p all > 0.05). Conclusions Atorvastatin treatment does not significantly affect circulating adiponectin. Influences of atorvastatin on atherosclerosis and glycemic metabolism are not likely to be mediated by modulation of circulating adiponectin.


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