-
BMC Medicine May 2022Factors contributing to the lack of understanding of research studies include poor reporting practices, such as selective reporting of statistically significant findings... (Review)
Review
BACKGROUND
Factors contributing to the lack of understanding of research studies include poor reporting practices, such as selective reporting of statistically significant findings or insufficient methodological details. Systematic reviews have shown that prognostic factor studies continue to be poorly reported, even for important aspects, such as the effective sample size. The REMARK reporting guidelines support researchers in reporting key aspects of tumor marker prognostic studies. The REMARK profile was proposed to augment these guidelines to aid in structured reporting with an emphasis on including all aspects of analyses conducted.
METHODS
A systematic search of prognostic factor studies was conducted, and fifteen studies published in 2015 were selected, three from each of five oncology journals. A paper was eligible for selection if it included survival outcomes and multivariable models were used in the statistical analyses. For each study, we summarized the key information in a REMARK profile consisting of details about the patient population with available variables and follow-up data, and a list of all analyses conducted.
RESULTS
Structured profiles allow an easy assessment if reporting of a study only has weaknesses or if it is poor because many relevant details are missing. Studies had incomplete reporting of exclusion of patients, missing information about the number of events, or lacked details about statistical analyses, e.g., subgroup analyses in small populations without any information about the number of events. Profiles exhibit severe weaknesses in the reporting of more than 50% of the studies. The quality of analyses was not assessed, but some profiles exhibit several deficits at a glance.
CONCLUSIONS
A substantial part of prognostic factor studies is poorly reported and analyzed, with severe consequences for related systematic reviews and meta-analyses. We consider inadequate reporting of single studies as one of the most important reasons that the clinical relevance of most markers is still unclear after years of research and dozens of publications. We conclude that structured reporting is an important step to improve the quality of prognostic marker research and discuss its role in the context of selective reporting, meta-analysis, study registration, predefined statistical analysis plans, and improvement of marker research.
Topics: Biomarkers, Tumor; Humans; Prognosis; Research Design
PubMed: 35546237
DOI: 10.1186/s12916-022-02304-5 -
European Neurology 2022Although symptomatic manifestations in encephalitis vary, they typically include seizures, memory deficit(s), and altered consciousness. Psychosis also occurs as an...
INTRODUCTION
Although symptomatic manifestations in encephalitis vary, they typically include seizures, memory deficit(s), and altered consciousness. Psychosis also occurs as an initial manifestation. In clinical practice, clinicians often encounter the question of whether first-episode psychosis (FEP) originates from encephalitis itself or if encephalitis presenting with FEP develops concurrently. The prognosis of FEP among patients with overall encephalitis, including autoimmune encephalitis, remains uncertain.
METHODS
We examined a prognostic factor in patients with encephalitis who had both FEP and CSF pleocytosis. A total of 36 patients who presented with FEP were enrolled. A score of ≥3 and ≤2 on the modified Rankin scale were defined as poor and good outcomes, respectively. A total of 13 independent variables were analyzed by the multivariate logistic regression analysis.
RESULTS
Significant variables on univariate logistic regression analysis included female sex (OR 5.571, 95% CI: 1.297-23.934; p = 0.021) and the use of mechanical ventilation during the acute stage (OR 7.286, 95% CI: 1.508-35.211; p = 0.013). On multivariate logistic regression analysis, the use of mechanical ventilation during the acute stage (OR 5.446, 95% CI: 1.044-28.615; p = 0.044) was significantly associated with poor outcomes.
CONCLUSIONS
The use of mechanical ventilation is a poor prognostic factor of subacute encephalitis with FEP, and female sex may be a risk factor for unfavorable development of the disease.
Topics: Humans; Female; Prognosis; Hashimoto Disease; Encephalitis; Psychotic Disorders; Risk Factors
PubMed: 35671738
DOI: 10.1159/000524975 -
BMC Medical Research Methodology Jun 2020Prognostic research has many important purposes, including (i) describing the natural history and clinical course of health conditions, (ii) investigating variables...
BACKGROUND
Prognostic research has many important purposes, including (i) describing the natural history and clinical course of health conditions, (ii) investigating variables associated with health outcomes of interest, (iii) estimating an individual's probability of developing different outcomes, (iv) investigating the clinical application of prediction models, and (v) investigating determinants of recovery that can inform the development of interventions to improve patient outcomes. But much prognostic research has been poorly conducted and interpreted, indicating that a number of conceptual areas are often misunderstood. Recent initiatives to improve this include the Prognosis Research Strategy (PROGRESS) and the Transparent Reporting of a multivariable prediction model for Individual Prognosis or Diagnosis (TRIPOD) Statement. In this paper, we aim to show how different categories of prognostic research relate to each other, to differentiate exploratory and confirmatory studies, discuss moderators and mediators, and to show how important it is to understand study designs and the differences between prediction and causation.
MAIN TEXT
We propose that there are four main objectives of prognostic studies - description, association, prediction and causation. By causation, we mean the effect of prediction and decision rules on outcomes as determined by intervention studies and the investigation of whether a prognostic factor is a determinant of outcome (on the causal pathway). These either fall under the umbrella of exploratory (description, association, and prediction model development) or confirmatory (prediction model external validation and investigation of causation). Including considerations of causation within a prognostic framework provides a more comprehensive roadmap of how different types of studies conceptually relate to each other, and better clarity about appropriate model performance measures and the inferences that can be drawn from different types of prognostic studies. We also propose definitions of 'candidate prognostic factors', 'prognostic factors', 'prognostic determinants (causal)' and 'prognostic markers (non-causal)'. Furthermore, we address common conceptual misunderstandings related to study design, analysis, and interpretation of multivariable models from the perspectives of association, prediction and causation.
CONCLUSION
This paper uses a framework to clarify some concepts in prognostic research that remain poorly understood and implemented, to stimulate discussion about how prognostic studies can be strengthened and appropriately interpreted.
Topics: Humans; Probability; Prognosis; Research Design
PubMed: 32600262
DOI: 10.1186/s12874-020-01050-7 -
Cancer Control : Journal of the Moffitt... Oct 2015Prognosis is a key driver of clinical decision-making. However, available prognostication tools have limited accuracy and variable levels of validation. (Review)
Review
BACKGROUND
Prognosis is a key driver of clinical decision-making. However, available prognostication tools have limited accuracy and variable levels of validation.
METHODS
Principles of survival prediction and literature on clinician prediction of survival, prognostic factors, and prognostic models were reviewed, with a focus on patients with advanced cancer and a survival rate of a few months or less.
RESULTS
The 4 principles of survival prediction are (a) prognostication is a process instead of an event, (b) prognostic factors may evolve over the course of the disease, (c) prognostic accuracy for a given prognostic factor/ tool varies by the definition of accuracy, the patient population, and the time frame of prediction, and (d) the exact timing of death cannot be predicted with certainty. Clinician prediction of survival is the most commonly used approach to formulate prognosis. However, clinicians often overestimate survival rates with the temporal question. Other clinician prediction of survival approaches, such as surprise and probabilistic questions, have higher rates of accuracy. Established prognostic factors in the advanced cancer setting include decreased performance status, delirium, dysphagia, cancer anorexia-cachexia, dyspnea, inflammation, and malnutrition. Novel prognostic factors, such as phase angle, may improve rates of accuracy. Many prognostic models are available, including the Palliative Prognostic Score, the Palliative Prognostic Index, and the Glasgow Prognostic Score.
CONCLUSIONS
Despite the uncertainty in survival prediction, existing prognostic tools can facilitate clinical decision-making by providing approximated time frames (months, weeks, or days). Future research should focus on clarifying and comparing the rates of accuracy for existing prognostic tools, identifying and validating novel prognostic factors, and linking prognostication to decision-making.
Topics: Decision Making; Humans; Neoplasms; Palliative Care; Prognosis
PubMed: 26678976
DOI: 10.1177/107327481502200415 -
Digestion 2021Multiple primary malignancies (MPMs) are likely to develop in patients with colorectal cancer (CRC); however, their prognoses are unclear. This study aims to investigate...
INTRODUCTION
Multiple primary malignancies (MPMs) are likely to develop in patients with colorectal cancer (CRC); however, their prognoses are unclear. This study aims to investigate the prognostic impacts and clinicopathological features of multiple CRCs and extracolorectal malignancies (EMs) with CRC.
METHODS
We retrospectively evaluated a total of 22,628 patients with stage I-III CRC who underwent curative resection at 24 referral institutes in Japan between January 2004 and December 2012. MPMs were classified as synchronous CRCs (SCRCs), metachronous CRCs, synchronous EMs (SEMs), and metachronous EMs.
RESULTS
The presence of SCRCs (odds ratio 1.54, p < 0.001) was independently associated with SEMs in the multivariate analyses. SEMs were the strongest poor prognostic factor for OS (hazard ratio [HR] 2.21, p < 0.001) and RFS (HR 1.69, p < 0.001) compared with age, sex, and primary T and N factors. The incidence of stomach cancer was the highest in EMs, followed by lung, breast, and prostate cancers. Multiple CRCs were evenly distributed throughout the right-side colon to the rectum.
DISCUSSION/CONCLUSION
SEMs were a strong poor prognostic factor for patients with stage I-III CRC. Patients with CRC, particularly those with SCRCs, should be surveyed for SEMs, especially for stomach and lung cancers.
Topics: Colorectal Neoplasms; Humans; Incidence; Male; Neoplasm Staging; Neoplasms, Multiple Primary; Prognosis; Retrospective Studies
PubMed: 34261059
DOI: 10.1159/000517271 -
World Journal of Surgical Oncology Mar 2023The aims of this study were to establish and validate a nomogram model for predicting the survival of patients with early-onset stage I-II colon cancer (CC). (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
The aims of this study were to establish and validate a nomogram model for predicting the survival of patients with early-onset stage I-II colon cancer (CC).
METHODS
Data of eligible patients enrolled from 2012 to 2015 were extracted from the Surveillance, Epidemiology, and End Results (SEER) database. Patients were randomly allocated to training and validation groups in a 7:3 ratio. Significant prognostic factors were identified by univariate and multivariate analysis and a nomogram model constructed. The predictive performance of the nomogram was evaluated by the concordance index (C-index), calibration plots, and decision curve analysis.
RESULTS
Our study cohort comprised 3528 early-onset CC patients with stage I-II disease, 2469 of whom were allocated to the training cohort and 1059 to the validation cohort. Race, age, marital status, tumor grade, tumor size, tumor stage (T stage), and chemotherapy were considered the significant predictor by univariate analysis. Race, marital status, and T stage were found to be independent prognostic factors by multivariate analysis. The C-indexes of the nomogram were 0.724 and 0.692 in the training and validation cohorts, respectively. Likewise, the calibration plots showed good agreement regarding the probability of 3- and 5-year observed and nomogram-predicted overall survival in the training group. Decision curve analysis showed that the nomogram model was clinically practical and effective. Moreover, applying the nomogram enabled dividing of the patients into two cohorts with different risk scores. The low-risk group thus created had a better survival than the high-risk group.
CONCLUSIONS
We developed and validated a meaningful prognostic nomogram model for patients with early-onset stage I-II CC that clinicians can use to make better decisions for individual patients.
Topics: Humans; Nomograms; Prognosis; Colonic Neoplasms; Databases, Factual; Multivariate Analysis; SEER Program
PubMed: 36964525
DOI: 10.1186/s12957-023-02988-w -
Asian Journal of Surgery Dec 2022The association between NSM and prognosis of esophageal cancer remains controversial, though several studies have been conducted drawing their own conclusion. Therefore,... (Meta-Analysis)
Meta-Analysis Review
The association between NSM and prognosis of esophageal cancer remains controversial, though several studies have been conducted drawing their own conclusion. Therefore, we firstly carried out this meta-analysis aiming to explore the association. We performed a comprehensive literature search online, including PubMed, Embase and Web of Science. We selected deaths at 5 years and hazard ratio (HR) with 95% (CI) to perform the meta-analysis with Review Manager 5.3, predicting value of clinic-pathological features in NSM also been analyzed. A total of 7 studies were finally enrolled in this study. NSM, defined by either JSED criterion or anatomical compartment criterion, neither showed significant prognostic value on OS of esophageal cancer (P = 0.64), (P = 0.24). Subgroup analysis of JSED criterion, NSM was not a prognostic factor in solitary node metastasis patients (P = 0.39), whereas NSM demonstrated a poor prognostic factor (P = 0.01) for ESCC. Subgroup analysis according to anatomical criterion, NSM was a favorable factor for OS in middle thoracic ESCC (P = 0.003). Pathological N1 status was found to be a risk factor for NSM (P < 0.00001) according to JSED criterion and middle thoracic ESCC was identified as a predictor for NSM (P = 0.0003) according to anatomical compartment criterion. According to JSED criterion, NSM demonstrated poor prognosis on ESCC and N1 status was a risk factor for NSM. Concerning the anatomical compartment criterion, a favorable prognosis of NSM was found in middle thoracic ESCC and NSM was prone to occur in middle thoracic ESCC. CRD42021219333.
Topics: Humans; Prognosis; Esophageal Neoplasms; Carcinoma, Squamous Cell; Risk Factors; Proportional Hazards Models
PubMed: 35221181
DOI: 10.1016/j.asjsur.2021.12.071 -
Breast (Edinburgh, Scotland) Apr 2022The prognostic factors and optimal choice of treatment for primary neuroendocrine neoplasms of the breast (BNEN) remain to be defined. (Review)
Review
BACKGROUND
The prognostic factors and optimal choice of treatment for primary neuroendocrine neoplasms of the breast (BNEN) remain to be defined.
METHODS
Patients diagnosed with BNEN in China were retrospectively reviewed from the literature following the systematic search of China National Knowledge Infrastructure (CNKI), Chinese biomedical literature service system (sinomed), wanfang medical network, and Pubmed database. The clinical characteristics and different treatment modalities of patients with BNEN were evaluated.
RESULTS
A total of 209 cases with BNEN were enrolled. There were 204 female and 5 male patients. The median age was 51 years old (range, 17-82). Out of 209 patients with BNEN, 208 (99.5%) patients were treated with surgery (SG), 44 patients (21.1%) had received radiotherapy (RT), 173 patients (82.8%) experienced chemotherapy (CT). A total of 158 patients with hormone receptor (HR) positive (87.8%, 158/180) were treated with endocrine treatment (ET). The median follow-up time was 52.4 months (range, 6-144). The 3-year overall survival (OS) rate and 3-year disease-free survival (DFS) rate for the whole group were 93.7% and 85.3%, respectively. In univariate analyses, Ki67 expression ≥20%, HR negative, neuroendocrine carcinomas (NECs) were associated with decreased OS and DFS (P < 0.05). Patients treated with anthracycline/taxane-containing CT regimens, or taxane-containing CT regimens had superior OS and DFS than patients without those (P < 0.05). Among 69 patients with stage I who received CT had no significant differences in OS or DFS compared to those without CT. Multivariate Cox regression analysis showed that gender, HR expression, pathologic subtype, and CT were independent prognostic factors for DFS but not OS (P > 0.05).
CONCLUSIONS
The best selection of patients to get the most benefit from different treatment modalities warrant further exploration. The clinicopathological parameters including gender, HR expression, ki67 expression, pathologic type, stage, tumor size, and lymph node status may serve as both indicators of diagnosis and prognosis, and guide treatment decisions for BNEN.
Topics: Breast Neoplasms; Chemotherapy, Adjuvant; Disease-Free Survival; Female; Humans; Male; Middle Aged; Neoadjuvant Therapy; Neoplasm Staging; Prognosis; Retrospective Studies
PubMed: 35134665
DOI: 10.1016/j.breast.2022.01.013 -
Cancer Medicine Oct 2023Tumor regression grade (TRG) is a measure of histopathological response to neoadjuvant therapy (NAT). Post-therapy lymph node (ypN) metastasis was reported as a...
Tumor regression grade combined with post-therapy lymph node status: A novel independent prognostic factor for patients treated with neoadjuvant therapy followed by surgery in locally advanced gastroesophageal junction and gastric carcinoma.
BACKGROUND
Tumor regression grade (TRG) is a measure of histopathological response to neoadjuvant therapy (NAT). Post-therapy lymph node (ypN) metastasis was reported as a prognostic factor. However, the evaluation of the treatment effectiveness of NAT has not been well studied. Here, we explored whether TRG combined with ypN status could be a prognostic factor for gastroesophageal junction (GEJ) and gastric cancer (GC). Besides, we aimed at making clear the association of different neoadjuvant regimens with different TRG and ypN status.
METHODS
376 patients with GEJ or GC accepting NAT in Peking University Cancer Hospital were retrospectively collected from January 1, 2003 to June 30, 2021. According to TRG and ypN status, patients were innovatively categorized into four groups: TRG0N0, TRG1-3N0, TRG0-1N+, and TRG2-3N+. We applied Kaplan-Meier method and log-rank test to testify the differences in disease free survival (DFS) and overall survival (OS) among four groups. Univariate and multivariate analyses were performed to examine the relationships between TRG combined with ypN status and prognosis.
RESULTS
We observed significant survival differences among the four groups (p < 0.001, respectively). Median DFS and OS of patients with TRG0N0, TRG1-3N0, and TRG0-1N+ were not reached, whereas these of patients with TRG2-3N+ were 17.37 months (95% CI, 14.14-20.60 months) and 39.97 months (95% CI, 27.05-52.89 months). TRG combined with ypN status was still an independent predictor for both DFS (p < 0.001) and OS (p < 0.001) in multivariate analysis. Chi-squared test showed TRG combined with ypN status was significantly associated with different preoperative treatments (p < 0.001). Patients receiving immunotherapy achieved the highest TRG0N0 rate (31.9%).
CONCLUSION
Our results demonstrate that TRG combined with ypN status is a novel independent predictor of both DFS and OS in resectable, locally advanced GEJ and GC. Neoadjuvant immunotherapy achieved the highest TRG0N0 rate.
Topics: Humans; Prognosis; Stomach Neoplasms; Neoadjuvant Therapy; Retrospective Studies; Lymph Nodes; Carcinoma; Esophagogastric Junction; Neoplasm Staging
PubMed: 37749981
DOI: 10.1002/cam4.6597 -
Journal of Thoracic Oncology : Official... Oct 2010Thirty years have gone by since the Masaoka staging system of thymoma was proposed in 1981. Although the Masaoka staging system has been accepted by many surgeons and... (Review)
Review
INTRODUCTION
Thirty years have gone by since the Masaoka staging system of thymoma was proposed in 1981. Although the Masaoka staging system has been accepted by many surgeons and pathologists, some proposals of revision and improvements have been suggested. At this time, I reinvestigated the Masaoka staging system based on the recent follow-up study of the thymomas resected at Nagoya City University.
METHODS
Using the follow-up results of 211 thymomas in Nagoya, I analyzed the following aspects: (1) evaluation of the Masaoka staging system as a prognostic factor in the Nagoya series and (2) critical assessment of the proposals of revision to the Masaoka staging system.
RESULTS
(1) Univariate analysis showed that Masaoka stages were significantly prognostic for overall survival (p < 0.0001). (2) The difference of survivals between stage I and II was not significant, but progression-free survival of stage I was 100% for up to 20 years, whereas one tumor death case in stage II was found. (3) Differences of survival between the cases with and without great vessel invasion in stage III were not significant. (4) Prognosis of N tumors was yet better defined.
CONCLUSION
(1) The Masaoka staging system remains a valuable prognostic factor. (2) Combination of stage I with II and separation of stage III into subgroups are not recommended. (3) At the moment, it is better to include N tumors in stage IVb.
Topics: Humans; Neoplasm Staging; Prognosis; Thymoma; Thymus Neoplasms
PubMed: 20859124
DOI: 10.1097/JTO.0b013e3181f20c05