Discussion

Author(s):  
Patricia Cerrito ◽  
John Cerrito

Now that the data are more readily available for outcomes research and the techniques to analyze that data are available, we need to use the tools to investigate the total complexity of patient care. We should no longer rely upon basic tools while ignoring sequential treatments for patients with chronic diseases or the issue of patient compliance, and we can start investigating treatments from birth to death. It is no longer possible, with these large datasets, to rely on t-tests, chi-square statistics and simple linear regression. Without the luxury of clinical trials and randomizing patients into treatment versus control, there will always be confounding factors that should be considered in the data. In addition, large datasets almost guarantee that the p-value in a standard regression is statistically significant, so other methods of model adequacy must be used. If we do not start using outcomes data, we are missing crucial knowledge that can be used to improve patient outcomes while simultaneously reducing the cost of care. If we continue to use inferential statistical methods that were not designed to work with large datasets, we will not extract the information that is readily available in the outcomes datasets.

2021 ◽  
Vol 11 (7) ◽  
pp. 908
Author(s):  
Spyridon Siafis ◽  
Alessandro Rodolico ◽  
Oğulcan Çıray ◽  
Declan G. Murphy ◽  
Mara Parellada ◽  
...  

Introduction: Response to treatment, according to Clinical Global Impression-Improvement (CGI-I) scale, is an easily interpretable outcome in clinical trials of autism spectrum disorder (ASD). Yet, the CGI-I rating is sometimes reported as a continuous outcome, and converting it to dichotomous would allow meta-analysis to incorporate more evidence. Methods: Clinical trials investigating medications for ASD and presenting both dichotomous and continuous CGI-I data were included. The number of patients with at least much improvement (CGI-I ≤ 2) were imputed from the CGI-I scale, assuming an underlying normal distribution of a latent continuous score using a primary threshold θ = 2.5 instead of θ = 2, which is the original cut-off in the CGI-I scale. The original and imputed values were used to calculate responder rates and odds ratios. The performance of the imputation method was investigated with a concordance correlation coefficient (CCC), linear regression, Bland–Altman plots, and subgroup differences of summary estimates obtained from random-effects meta-analysis. Results: Data from 27 studies, 58 arms, and 1428 participants were used. The imputation method using the primary threshold (θ = 2.5) had good performance for the responder rates (CCC = 0.93 95% confidence intervals [0.86, 0.96]; β of linear regression = 1.04 [0.95, 1.13]; bias and limits of agreements = 4.32% [−8.1%, 16.74%]; no subgroup differences χ2 = 1.24, p-value = 0.266) and odds ratios (CCC = 0.91 [0.86, 0.96]; β = 0.96 [0.78, 1.14]; bias = 0.09 [−0.87, 1.04]; χ2 = 0.02, p-value = 0.894). The imputation method had poorer performance when the secondary threshold (θ = 2) was used. Discussion: Assuming a normal distribution of the CGI-I scale, the number of responders could be imputed from the mean and standard deviation and used in meta-analysis. Due to the wide limits of agreement of the imputation method, sensitivity analysis excluding studies with imputed values should be performed.


2020 ◽  
Vol 11 (1) ◽  
pp. 38-45
Author(s):  
Sara Sara Tania

The number of disorders, anxiety reached 5% of the world’s population. The comparison with anxiety disorders in women and men is 2 to 1. It is estimated that 2%-4% of the world have experienced anxiety disorders. Anxiety to be caused by disease, the cost of treatment, a new environment, diagnostic procedures, treatment and procedures of nursing, including acts of invasive like surgery, the act of taking blood, the installation of a catheter and others. To determine the relationship long the installation of a catheter with the level of anxiety in patients hospitalized in PMI Hospital of Bogor City. This kind of research is analytic with cross sectional desain. The method of taking samples in this study with a Quota Sampling technique with sample of 68 respondents. Collection of data obtainbed through teh distribution of a questinnare and observation. Based on the results of the research that 22 respondents (44,0%) be categorized not long to having too low. The Statistical test result were obtained by using chi square that p value = 0,023, which means p value < 0,05 then Ho is reject and Ha accepted. So that, there is relationship between the installation of a catheter with level anxiety inpatients PMI Hospital Bogor. The researcher expected that this research can provide information to the hospital in the framework of the quality of nursing services, especially in touch with a patient attached the catheter to experience anxiety.


2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e22036-e22036
Author(s):  
Elisabetta Rossi ◽  
Antonella Facchinetti ◽  
Angela Grassi ◽  
Carlo Riccardo Rossi ◽  
Silvia Stragliotto ◽  
...  

e22036 Background: The CMC analysis was recently improved by the CellSearch platform that offers an accurate (and reproducible) assessment of tumor burden, to be used as prognosticator and predictor of treatment response.Moreover, not only decreased total circulating cells numbers but also increased fraction of apoptotic cells may represent response-related markers. To monitor changes in the balance between live and apoptotic Circulating Tumor Cells (CTCs) ( Rossi, Basso et al. 2010 ) during therapy, a novel CTCs assay with a companion algorithm (the ΔAUC) was reported to be a pharmacodynamic marker, as documented by consistent radiological findings in MBC and mRCC patients. Methods: Fluorescent anti γ-H2AX mAb (specific for the phosphorylated form of H2AX) was integrated in the standard CMC assay to assess DNA damage and to measure cell viability and apoptosis in spreading melanoma cells. The integrated test was developed using MCF-7 and SK23mel cells line and tested in melanoma patients. From June-2011 till now, basal blood samples from 64 patients (pts) in stage IV were collected; median age 62 (range: 27-85). Both considering the cost of the CMC assay and the little already known about this new method in melanoma, to evaluate the feasibility of CMC retrieval and ΔAUC calculation an interim analysis was specified in the study protocol and conducted at September 2012 on the first 40 pts. Results: At baseline, in Padova’s cohort 72.6% of pts are CMC-positive. The CMC number ranged from 1 to 94. The γ-H2AX-positive CMCs ranged from 0% to 100% (median 67%). Shorter median Progression-free survival PFS was observed for patients who had > 2 CMCs (n=26, 162 days) compared with < 2 CMCs patients (n=14, 203 days, P value = 0.0270). No significant differences were found with the ΔAUC criterion (i.e. exceeding live vs apoptotic CMCs). Furthermore, a significant association was found between CMC-positive status at baseline and disease sites at progression (visceral and CNS, Chi-square = 8,521 with 3 df, P value = 0.036). Conclusions: Accrual is ongoing. Updated data including evaluations on prognostic value of total and apoptotic CMCs and correlation with clinical stage, tumor burden, metastatic sites and survival will be available and presented at the meeting.


2019 ◽  
Vol 4 (2) ◽  
pp. 252
Author(s):  
Sulaiman Sulaiman ◽  
Anggriani Anggriani

<p><em>Good hospital services so far still seem difficult to obtain by the community when they want to seek treatment for services. Good service is a very important thing to improve patient satisfaction especially in poly physiotherapy at Siti Hajar Hospital Medan. This type of research was descriptive with a "cross sectional" design, the population in this research were 150 respondents who came to poly physiotherapy. Samples that meet the criteria in this research are 30 selected respondents. Sampling by means of "systematic sampling techniques. The purpose of this research was to analyze the relationship of factors of reliability, assurance, responsiveness, empathy, and physical evidence to the satisfaction of physiotherapy patient. The results of this research show that the majority of respondents stated that the quality of service in the poly physiotherapy at the Siti Hajar  Hospital in Medan was quite good at 14 people (46.7%). These results indicate there is a relationship between the quality of physiotherapy services and satisfaction, this is evident from the results of chi-square analysis where p-value = 0.004, smaller than 0.005. The conclusion in this resarch is that the hospital gives priority to the development of the quality of physiotherapy services, especially on poly physiotherapy.</em></p><p><em><br /></em></p><p><em><em>Pelayanan rumah sakit yang maksimal selama ini masih terkesan sulit didapatkan masyarakat ketika hendak berobat untuk mendapatkan  pelayanan. Pelayanan yang baik merupakan hal yang sangat penting untuk meningkatkan kepuasan pasien khususnya di poli fisioterapi RSU Siti Hajar Medan. Jenis penelitian ini deskriptif dengan rancangan “cross sectional”, populasi dalam penelitian ini sebanyak 150 orang responden yang datang ke poli fisioterapi. Sampel yang memnuhi kriteria dalam penelitian ini adalah pasien yang terpilih sebanyak 30 orang responden. Pengambilan sampel dengan cara “teknik sampling sistematis. Tujuan penelitian ini adalah untuk menganalisis hubungan faktor kehandalan, jaminan, daya tanggap, empati, dan bukti fisik terhadap kepuasan pasien fisioterapi. Hasil penelitian memperlihatkan bahwa mayoritas responden menyatakan mutu pelayanan di poli fisioterapis RSU Siti Hajar Medan adalah cukup baik yakni sebanyak 14 orang (46.7%). Hasil ini juga menunjukan ada hubungan mutu pelayanan fisioterapi dengan kepuasan, hal ini terbukti dari  hasil analisis chi-square dimana p-value = 0.004, lebih kecil dari 0.005. Kesimpulan dalam Penelitian ini bahwa pihak rumah sakit memberikan prioritas  pengembangan mutu pelayanan Fisioterapi terutama pada poli fisioterapi.</em></em></p>


2002 ◽  
Vol 23 (4) ◽  
pp. 177-182 ◽  
Author(s):  
Christopher S. Hollenbeak ◽  
Denise Murphy ◽  
William C. Dunagan ◽  
Victoria J. Fraser

Objective:To study the extent to which selection bias poses problems for estimating the attributable cost of deep chest surgical-site infection (SSI) following coronary artery bypass graft (CABG) surgery.Design:Reanalysis of a prospective case–control study.Setting:A large, Midwestern community medical center.Patients:Cases were all patients who had an SSI (N = 41) following CABG and CABG and valve surgery between April 1996 and March 1998. Controls were every tenth uninfected patient (N = 160).Methods:Estimates of the attributable cost of deep chest SSI were computed using unmatched comparison, matched comparison, linear regression, and Heckman's two-stage approach.Results:The attributable cost of deep chest SSI was estimated to be $20,012 by unmatched comparison, $19,579 by matched comparison, $20,103 by linear regression, and $14,211 by Heckman's two-stage method. Controlling for selection bias substantially reduced the cost estimate, but the coefficient capturing selection bias was not statistically significant.Conclusions:Deep chest SSI significantly increases the cost of care for patients who undergo CABG surgery. Unmatched comparison, matched comparison, and linear regression estimated the attributable cost to be approximately $20,000. Although controlling for selection bias with Heckman's two-stage method resulted in a substantially smaller estimate, the coefficient for selection bias was not statistically significant, suggesting that the estimates derived from the other models should be acceptable. However, the magnitude of the difference between the models shows that the effect of selection bias can be substantial. Some exploration for selection bias is recommended when estimating the attributable cost of SSIs.


2021 ◽  
Vol 10 (16) ◽  
pp. 3578
Author(s):  
Hansol Kang ◽  
Ryan M. Thomas

The microbiome is the metagenome of all microbes that live on and within every individual, and evidence for its role in the pathogenesis of a variety of diseases has been increasing over the past several decades. While there are various causes of sepsis, defined as the abnormal host response to infection, the host microbiome may provide a unifying explanation for discrepancies that are seen in septic patient survival based on age, sex, and other confounding factors. As has been the case for other human diseases, evidence exists for the microbiome to control patient outcomes after sepsis. In this review, associative data for the microbiome and sepsis survival are presented with causative mechanisms that may be at play. Finally, clinical trials to manipulate the microbiome in order to improve patient outcomes after sepsis are presented as well as areas of potential future research in order to aid in the clinical treatment of these patients.


2011 ◽  
Vol 67 (1) ◽  
Author(s):  
A. Basson

Low back pain (LBP) is an increasingly debilitating and costly problem. One of the research focuses in LBP is an attempt to improve patient outcomes. It is believed that the promotion of evidence based practice (EBP) should improve patient outcomes and also reduce the cost of care. There seems to be a need to establish how physiotherapists manage LBP and whether management is in accordance with best practice based on published research evidence. The aim of this study was to determine what management strategies physiotherapists employ in the management of LBP by performing a review of the literature and to compare this with recent guidelines Fourteen studies were included for the review.  The treatments most frequently reported as being used for the management of LBP were education/ advice, exercise, spinal mobilisation and electrotherapy. Over a 14 year period there were no major changes in the way physiotherapists manage LBP. Physiotherapist use interventions that are evidence based as well as interventions with little evidence in the management of LBP.


2020 ◽  
Vol 9 (2) ◽  
pp. 726-732
Author(s):  
Riqqah Nadhira ◽  
Irwan Saputra ◽  
Said Usman ◽  
Bakhtiar Bakhtiar ◽  
Nurjannah Nurjannah

This study was an observational analytic study conducted in the Hemodialysis unit of Zainal Abidin Hospital (RSUDZA), Banda Aceh, Indonesia. Data collection was carried out by taking secondary data from CKD patient visits in January-December 2019. The study population was all CKD patients in the registry of 2019 in the hospital, with a total of 406 patients enrolled. The highest unit cost of care based on real costs was the cost of surgical procedures, and the cost difference between INA-CBG’s and hospital tariffs in the treatment of patients with CKD is significantly different (p-value = 0.014, with gap difference of IDR 2,146,086). It is suggested  an urgent evaluation and scrutinization for the management of CKD patients with hemodialysis to prevent the different treatment costs in the service


2017 ◽  
Vol 35 (7_suppl) ◽  
pp. 93-93
Author(s):  
Neil Thomas Mason ◽  
Nikhil I. Khushalani ◽  
Scott Joseph Antonia ◽  
Howard L. McLeod

93 Background: Recently approved PD-1 inhibitors such as nivolumab have demonstrated clear efficacy in metastatic melanoma and other cancers, but also come at a high cost and with the potential for severe side effects. However, most of the data available comes from clinical trials rather than patients treated in clinical practice as standard-of-care. This study reports the incidence of severe toxicities in a number of cancer types and estimates the per patient cost of managing these toxicities. Methods: Patients with metastatic melanoma, non-small cell lung cancer, renal cell carcinoma, and Hodgkin’s lymphoma treated with nivolumab between January 1, 2014 through April 30, 2016 were identified at Moffitt Cancer Center (N=74). Toxicities occurring during treatment or within 2 months of stopping treatment were identified by a chart review and each toxicity graded using the CTCAE 4.0 criteria. A cost of care analysis was performed to estimate the cost of serious toxicities (Grade 3-5) compared to a control group who experienced no or minor adverse events (Grade 0-2). Billing data was used to estimate the mean cost of care for each group. Costs were subcategorized by service line, e.g., pharmacy costs, radiology, laboratory services. Results: The most common severe toxicities were anemia, dyspnea, renal failure, colitis, fatigue, and pneumonitis (Table 1). The average cost of care for patients experiencing grade 3-5 toxicities was $2,036 higher than those without toxicity. Conclusions: The incidence of toxicity in our population was similar to that reported in clinical trials. Costs were higher for patients with toxicities, driven by additional outpatient care (19% higher cost per patient) as well as additional pharmacy costs (22% higher per patient). Though small in comparison to the cost of nivolumab, over $6,000 per dose, these costs should not be dismissed, particularly when performing cost effectiveness and value research. [Table: see text]


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19406-e19406
Author(s):  
Cole Friedes ◽  
Sarah Hazell ◽  
Wei Fu ◽  
Chen Hu ◽  
Beverly Lee ◽  
...  

e19406 Background: Financial toxicity (FT), or the cost-related side effect of cancer therapy, has been linked to poor clinical outcomes, greater symptom burden, and worse quality of life. While the repercussions of FT have been thoroughly explored, the longitudinal patient relationship with FT in the initial course of therapy is unknown. Methods: Patients with stage II – IV lung cancer were recruited in a prospective longitudinal non-interventional study between July 2018 and January 2020. FT was measured via the COST score, a validated questionnaire for benchmarking FT, at a) the time of cancer diagnosis and then later at b) 6-month follow up (6MFU). In this model, a lower COST score indicates increased financial hardship. Completed 6MFU data was compared to corresponding baseline data for each patient. Linear regression analysis was used to compare patient characteristics with baseline COST (COSTbase) and 6-month COST (COST6M) scores. Results: At the time of analysis, 209 patients were screened and 194 (95.1%) patients agreed to participate and complete the baseline survey. Subsequently, 93 patients completed the 6MFU survey, 32 patients had died, and 7 patients were lost to follow up. The remaining 62 patients have not met the study end point to date. Of the 93 patients that completed the 6MFU and baseline survey, the median age was 65 (range 35-89), 50.5% were male, and 76.3% were Caucasian. Over the first six months of therapy 36.5% overestimated OOP expenses by > $1000 and 22.5% reported a decrease in total monetary savings, but only 4.3% of patients made decisions about health care based on cost of care. FT was present at both time points but was worse at diagnosis than at 6MFU (median COSTbase 25 [range 1-44] vs. median COST6M 27 [range 0-44]; p = 0.04). Linear regression correlated risk factors with FT at baseline ( < 1 month monetary savings, employed but on sick leave, and inability to afford basic necessities; all p < 0.001) that were different from risk factors at 6MFU (paying much more than expected OOP and sacrificing spending to meet medical costs; p < 0.001). There was no significant difference between estimated OOP costs at baseline (median $2550 [range $0 - $500,000]) and actual OOP costs (median $2496 [range $0 – 25,900]; p = 0.25). Conclusions: FT toxicity is pervasive at both diagnosis and at 6-month follow up, however, the magnitude of toxicity changes with time. Few patients are willing to sacrifice medical care regardless of the cost. Risk factors for FT evolve, suggesting that different groups may benefit from financial intervention at diagnosis versus 6MFU.


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