The Fate of Patients with Solitary Pulmonary Nodules: Clinical Management and Radiation Exposure Associated.

BACKGROUND: The appropriate management of the large number of lung nodules detected during the course of routine medical care presents a challenge. We aimed to evaluate the usual clinical practice in solitary pulmonary nodule (SPN) management and associated radiation exposure. METHODS: We examined 893 radiology reports of consecutive patients undergoing chest computed tomography (CT) and radiography at two public hospitals in Spain. Information on diagnostic procedures from SPN detection and lung cancer diagnosis was collected prospectively for 18 months. RESULTS: More than 20% of patients with SPN detected on either chest radiograph (19.8%) or CT (26.1%) underwent no additional interventions and none developed lung cancer (100% negative predictive value). 346 (72.0%) patients with SPN detected on chest radiograph and 254 (61.5%) patients with SPN detected on CT had additional diagnostic tests and were not diagnosed with lung cancer. In patients undergoing follow-up imaging for SPNs detected on CT median number of additional imaging tests was 3.5 and the mean cumulative effective dose was 24.4 mSv; for those detected on chest radiograph the median number of additional imaging tests was 2.8 and the mean cumulative effective dose was 10.3 mSv. CONCLUSIONS: Patients who did not have additional interventions were not diagnosed of lung cancer. There was an excessive amount of interventions in a high percentage of patients presenting SPN, which was associated with an excess of radiation exposure.

Lung cancer risk and cancer-specific mortality in subjects undergoing routine imaging test when stratified with and without identified lung nodule on imaging study.

OBJECTIVES: To assess the risk of lung cancer and specific mortality rate in patients with and without solitary pulmonary nodules (SPN) on chest radiograph and CT. METHODS: This prospective study included 16,078 patients ≥35 years old (893 of them had an SPN detected with either chest radiograph or CT) and 15,185 without SPN. Patients were followed up for 18 months or until being diagnosed with lung cancer. Risk and mortality lung cancer were calculated in both groups with Poisson regression. RESULTS: In patients with SPN, incidence of lung cancer was 8.3 % (95 % CI 6.0-11.2) on radiograph and 12.4 % (95 % CI 9.3-15.9) on CT. A chronic obstructive pulmonary disease in patients with radiographs (odds ratio 2.62; 95 % CI 1.03, 6.67) and smoking habit (odds ratio 20.63; 95 % CI 3.84, 110.77) in patients with CT were associated with a higher probability of lung cancer. Large nodule size and spiculated edge were associated with lung cancer on both CT and radiograph. Lung cancer-specific mortality was lower in patients with SPN than in those without SPN (1.73/1000 person-years, 95 % CI 1.08-2.88 vs. 2.15/1000 person-years, 95 % CI 1.25-3.96). CONCLUSIONS: The risk of lung cancer for patients with SPN is higher in clinical populations than in screening studies. Moreover, patients with SPN showed lower mortality than those without SPN. KEY POINTS: • Lung cancer risk is 8 % for SPN detected on routine radiographs. • Lung cancer risk is 12.4 % for SPN detected in routine chest CT. • Smoking, COPD, SPN diameter and edge were predictors of malignancy. • Lung cancer risk of SPN in routine practice seems higher than in screening.

Management of patients with incidental findings in imaging tests: a large prospective single-center study.

We prospectively followed up patients with an incidental finding detected in an image test to assess the additional interventions carried out and the clinical implications of the incidental findings detected. Out of 474 patients with an incidental finding, 63 (13.3%) were further evaluated, and of these patients, 25 (39.7%) had clinical implications. Patients who had an X-ray (24/76, 31.6%), with a preoperative examination (19/77 24.7%), and with an incidental finding in the thoracic cavity (34/117, 29.1%) or in the head/neck (6/28, 21.4%) were more likely to have additional evaluations.

Methodological deficits in diagnostic research using '-omics' technologies: evaluation of the QUADOMICS tool and quality of recently published studies.

BACKGROUND: QUADOMICS is an adaptation of QUADAS (a quality assessment tool for use in systematic reviews of diagnostic accuracy studies), which takes into account the particular challenges presented by '-omics' based technologies. Our primary objective was to evaluate the applicability and consistency of QUADOMICS. Subsequently we evaluated and describe the methodological quality of a sample of recently published studies using the tool. METHODOLOGY/PRINCIPAL FINDINGS: 45'-omics'-based diagnostic studies were identified by systematic search of Pubmed using suitable MeSH terms ("Genomics", "Sensitivity and specificity", "Diagnosis"). Three investigators independently assessed the quality of the articles using QUADOMICS and met to compare observations and generate a consensus. Consistency and applicability was assessed by comparing each reviewer's original rating with the consensus. Methodological quality was described using the consensus rating. Agreement was above 80% for all three reviewers. Four items presented difficulties with application, mostly due to the lack of a clearly defined gold standard. Methodological quality of our sample was poor; studies met roughly half of the applied criteria (mean +/- sd, 54.7+/-18.4%). Few studies were carried out in a population that mirrored the clinical situation in which the test would be used in practice, (6, 13.3%); none described patient recruitment sufficiently; and less than half described clinical and physiological factors that might influence the biomarker profile (20, 44.4%). CONCLUSIONS: The QUADOMICS tool can consistently be applied to diagnostic '-omics' studies presently published in biomedical journals. A substantial proportion of reports in this research field fail to address design issues that are fundamental to make inferences relevant for patient care.

Estudio observacional: evaluación de la calidad metodológica de la investigación diagnóstica en España tras la publicación de la guía STARD / Observacional study: Evaluation of the diagnostic research methodology in Spain after STARD publication

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