Logistic regression analysis is a statistical technique to evaluate the relationship between various predictor variables (either categorical or continuous) and an outcome which is binary ...(dichotomous). In this article, we discuss logistic regression analysis and the limitations of this technique.
Agreement between measurements refers to the degree of concordance between two (or more) sets of measurements. Statistical methods to test agreement are used to assess inter-rater variability or to ...decide whether one technique for measuring a variable can substitute another. In this article, we look at statistical measures of agreement for different types of data and discuss the differences between these and those for assessing correlation.
Cancer Management in India during Covid-19 Pramesh, C.S; Badwe, Rajendra A
New England journal of medicine/The New England journal of medicine,
05/2020, Letnik:
382, Številka:
20
Journal Article
Recenzirano
Odprti dostop
India’s largest cancer center adopts a proactive, multipronged approach to providing treatment, while facing the reality that some services must be scaled back during a nationwide lockdown. ...Prioritization criteria guide treatment decisions.
Introduction
Enhanced recovery after surgery (ERAS) programs provide a format for multidisciplinary care and has been shown to predictably improve short term outcomes associated with surgical ...procedures. Esophagectomy has historically been associated with significant levels of morbidity and mortality and as a result routine application and audit of ERAS guidelines specifically designed for esophageal resection has significant potential to improve outcomes associated with this complex procedure.
Methods
A team of international experts in the surgical management of esophageal cancer was assembled and the existing literature was identified and reviewed prior to the production of the guidelines. Well established procedure specific components of ERAS were reviewed and updated with changes relevant to esophagectomy. Procedure specific, operative and technical sections were produced utilizing the best current level of evidence. All sections were rated regarding the level of evidence and overall recommendation according to the evaluation (GRADE) system.
Results
Thirty-nine sections were ultimately produced and assessed for quality of evidence and recommendations. Some sections were completely new to ERAS programs due to the fact that esophagectomy is the first guideline with a thoracic component to the procedure.
Conclusions
The current ERAS society guidelines should be reviewed and applied in all centers looking to improve outcomes and quality associated with esophageal resection.
Esophageal cancer surgery, comprising esophagectomy with radical lymphadenectomy, is a complex procedure associated with considerable morbidity and mortality. The enhanced recovery after surgery ...(ERAS) protocol which aims to improve perioperative care, minimize complications, and accelerate recovery is showing promise for achieving better perioperative outcomes. ERAS is a multimodal approach that has been reported to shorten the length of hospital stay, reduce surgical stress response, decrease morbidity, and expedite recovery. While ERAS components straddle preoperative, intraoperative, and postoperative periods, they need to be seen in continuum and not as isolated elements. In this review, we elaborate on the components of an ERAS protocol after esophagectomy including preoperative nutrition, prehabilitation, counselling, smoking and alcohol cessation, cardiopulmonary evaluation, surgical technique, anaesthetic management, intra- and postoperative fluid management and pain relief, mobilization and physiotherapy, enteral and oral feeding, removal of drains, and several other components. We also share our own institutional protocol for ERAS following esophageal resections.
Virtual clinical trials refer to clinical trials that take advantage of digital technologies, including computer and mobile device apps, web-based tools, and remote monitoring devices, for one or ...more of the trial processes, such as participant recruitment, counseling, informed consent, measurement of endpoints, and/or adverse event monitoring, to obviate or reduce the need for participant visits to the trial site. The advantages of such trials may include higher recruitment rates, better compliance, lower dropout rates, reduction in time for trial completion, and lower costs. The use of such trials increased manifold during the COVID-19 pandemic and is likely to continue in the future.
Summary Background The American Society of Clinical Oncology (ASCO) and the European Society for Medical Oncology (ESMO) have developed frameworks that quantify survival gains in light of toxicity ...and quality of life to assess the benefits of cancer therapies. We applied these frameworks to a cohort of contemporary randomised controlled trials to explore agreement between the two approaches and to assess the relation between treatment benefit and cost. Methods We identified all randomised controlled trials of systemic therapies in non-small-cell lung cancer, breast cancer, colorectal cancer, and pancreatic cancer published between Jan 1, 2011, and Dec 31, 2015, and assessed their abstracts and methods. Trials were eligible for inclusion in our cohort if significant differences favouring the experimental group in a prespecified primary or secondary outcome were reported (secondary outcomes were assessed only if primary outcomes were not significant). We assessed trial endpoints with the ASCO and ESMO frameworks at two timepoints 3 months apart to confirm intra-rater reliability. Cohen's κ statistic was calculated to establish agreement between the two frameworks on the basis of the median ASCO score, which was used as an arbitrary threshold of benefit, and the framework-recommended ESMO threshold. Differences in monthly drug cost between the experimental and control groups of each randomised controlled trial (ie, incremental drug cost) were derived from 2016 average wholesale prices. Findings 109 randomised controlled trials were eligible for inclusion, 42 (39%) in non-small-cell lung cancer, 36 (33%) in breast cancer, 25 (23%) in colorectal cancer, and six (6%) in pancreatic cancer. ASCO scores ranged from 2 to 77; median score was 25 (IQR 16–35). 41 (38%) trials met the benefit thresholds in the ESMO framework. Agreement between the two frameworks was fair (κ=0·326). Among the 100 randomised controlled trials for which drug costing data were available, ASCO benefit score and monthly incremental drug costs were negatively correlated (ρ=–0·207; p=0·039). Treatments that met ESMO benefit thresholds had a lower median incremental drug cost than did those that did not meet benefit thresholds (US$2981 IQR 320–9059 vs $8621 1174–13 930; p=0·018). Interpretation There is only fair correlation between these two major value care frameworks, and negative correlations between framework outputs and drug costs. Delivery of optimal cancer care in a sustainable health system will necessitate future oncologists, investigators, and policy makers to reconcile the disconnect between drug cost and clinical benefit. Funding None.
The burden of cancer falls disproportionally on low-middle-income countries (LMICs). It is not well known how novel therapies are tested in current clinical trials and the extent to which they match ...global disease burden.
To describe the design, results, and publication of oncology randomized clinical trials (RCTs) and examine the extent to which trials match global disease burden and how trial methods and results differ across economic settings.
In this retrospective cohort study, a literature search identified all phase 3 RCTs evaluating anticancer therapies published from 2014 to 2017. Randomized clinical trials were classified based on World Bank economic classification. Descriptive statistics were used to compare RCT design and results from high-income countries (HICs) and low/middle-income countries (LMICs). Statistical analysis was conducted in January 2020.
Differences in the design, results, and output of RCTs between HICs and LMICs.
The study cohort included 694 RCTs: 636 (92%) led by HICs and 58 (8%) led by LMICs. A total of 601 RCTs (87%) tested systemic therapy and 88 RCTs (13%) tested radiotherapy or surgery. The proportion of RCTs relative to global deaths was higher for breast cancer (121 RCTs 17% and 7% of deaths) but lower for gastroesophageal cancer (38 RCTs 6% and 14% of deaths), liver cancer (14 RCTs 2% and 8% of deaths), pancreas cancer (14 RCTs 2% and 5% of deaths), and cervical cancer (9 RCTs 1% and 3% of deaths). Randomized clinical trials in HICs were more likely than those in LMICs to be funded by industry (464 73% vs 24 41%; P < .001). Studies in LMICs were smaller than those in HICs (median, 219 interquartile range, 137-363 vs 474 interquartile range, 262-743 participants; P < .001) and more likely to meet their primary end points (39 of 58 67% vs 286 of 636 45%; P = .001). The observed median effect size among superiority trials was larger in LMICs compared with HICs (hazard ratio, 0.62 interquartile range, 0.54-0.76 vs 0.84 interquartile range, 0.67-0.97; P < .001). Studies from LMICs were published in journals with lower median impact factors than studies from HICs (7 interquartile range, 4-21 vs 21 interquartile range, 7-34; P < .001). Publication bias persisted when adjusted for whether a trial was positive or negative (median impact factor: LMIC negative trial, 5 interquartile range, 4-6 vs HIC negative trial, 18 interquartile range, 6-26; LMIC positive trial, 9 interquartile range, 5-25 vs HIC positive trial, 25 interquartile range, 10-48; P < .001).
This study suggests that oncology RCTs are conducted predominantly by HICs and do not match the global burden of cancer. Randomized clinical trials from LMICs are more likely to identify effective therapies and have a larger effect size than RCTs from HICs. This study suggests that there is a funding and publication bias against RCTs led by LMICs. Policy makers, research funders, and journals need to address this issue with a range of measures including building capacity and capability in RCTs.
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