Setefilla Luengo-Matos

Background: Robotic surgery (RS) may offer benefits compared with freehand/conventional surgery (FS) in the treatment of patients with spinal disease. The aim of this study was to evaluate the efficacy and safety of RS versus FS in spinal fusion. Methods: A systematic review and meta-analysis was performed. Data analysis and risk of bias assessment were analysed using REVMAN V5.3. Results: We found 11 randomised clinical trials involving 817 patients (FS: 408, RS: 409). The main diagnosis was degenerative spine disease. SpineAssist, Renaissance (Mazor Robotics), Tianji Robot and TiRobot robots (TINAVI Medical Technologies) were used. Pedicle screw placement within the safety zone (grades A + B according to the Gertzbein and Robbins scale) ranged from 93% to 100% in FS versus 85–100% in RS (relative risk 1.01, 95% CI 1.00–1.03, p = 0.14). Regarding intervention time, the meta-analysis showed a mean difference (MD) of 6.45 min (95% CI −13.59 to 26.49, p = 0.53). Mean hospital stay was MD of −0.36 days (95% CI −1.03 to 0.31, p = 0.30) with no differences between groups. Contradictory results were found regarding fluoroscopy time, although there seems to be a lower radiation dose in RS versus FS (p < 0.05). Regarding safety, the studies included surgical revision frequency. Conclusions: No conclusive results were found suggesting that there are benefits in using RS over FS for spinal fusion. Further research with adequate patient selection, robot type and quality-of-life variables is needed. Level of evidence: level 1.

Introduction Robotic surgery (RS) can offer benefits compared to freehand surgery (FS) in the treatment of patients with spinal diseases. The aim of this study was to assess efficacy and safety of RS versus FS in spinal fusion. The outcomes considered were accuracy in the placement of pedicle screws, surgical times, hospital stay, exposure to radiation, and complications. Methods A systematic review and meta-analysis were performed by researchers at the Instituto de Salud Carlos III (ISCIII). Studies published until June 2019 in the English, Spanish, or French languages were retrieved. The data analyses and risk of bias assessments were undertaken using RevMan 5.3. Results Eight randomized controlled trials including 610 patients (RS: 308, FS: 302) were found. The mean age of the patients ranged from 56 to 68 years in the FS group and from 55 to 68 years in the RS group. The percentage of women included ranged from 46 to 73 percent undergoing FS and from 33 to 70 percent undergoing RS. The main diagnosis was degenerative spine disease. The number of screws implanted ranged from 22 to 584 for FS and 23 to 532 for RS. The robots used were the SpineAssist and Renaissance Guidance System (Mazor Robotics, Ltd) and the TiRobot® Orthopaedic Robotic System (Beijing Tinavi Medical Technologies Co., Ltd). Pedicle screw placement within the safety zone (Grades A and B on the Gertzbein and Robbins scale) ranged from 93 to 100 percent in FS and from 85 to 100 percent in RS (relative risk 1.0, 95% confidence interval [CI] 0.99–1.03; p = 0.36) (I2=75%; p = 0.0005). Regarding intervention time, the meta-analysis showed a mean difference (MD) of 15.2 minutes (95% CI 5.35–25.05; p = 0.002) (I2 = 0%; p = 0.39) in favor of FS. The MD in hospital stay was 0.36 days (95% CI -1.03–0.31; p = 0.30) (I2 = 62%; p = 0.07), which was not statistically significant. Contradictory results were found for fluoroscopy time, although RS was associated with a lower radiation dose than FS (p < 0.05). In relation to safety, studies only reported on rates of surgical revision, which ranged from 0 to 2 after FS and from 0 to 10 after RS. The risk or bias was unclear in most studies. Conclusions We found no conclusive results suggesting benefits for spinal fusion using RS compared with FS. Further research with adequate selection of patients, type of robot, and comparator is needed.

Introduction Lung cancer is a leading cause of morbidity and mortality, and early diagnosis is essential for patient survival. Epigenetics is an innovative discipline that provides biomarkers to aid in early diagnosis, patient risk classification, or outcome prediction. Each type of tumor may present specific patterns of gene methylation, the analysis of which may be useful as a diagnostic tool. The aim of this study was to conduct an early assessment of novel in vitro diagnostic (IVD) tests based on the identification of DNA hypermethylation epigenetic signatures developed for the early detection of lung cancer. Methods We identified this technology through the Early Awareness and Alert System “SINTESIS-new technologies” of the Agencia de Evaluación de Tecnologías Sanitarias - Instituto de Salud Carlos III. A literature search of PubMed, the Trip Medical Database, the International Clinical Trials Registry Platform, ClinicalTrials.gov, and the Cochrane Central Register of Controlled Trials was conducted. Studies published up to November 2019 were reviewed. Results Three tests were identified. Epi proLung® analyzes the hypermethylation status of SHOX2/PTGER4 genes in blood samples using polymerase chain reaction (PCR) and showed good discrimination capacity with respect to healthy controls (area under the curve [AUC] = 0.91) and patients with non-malignant lung diseases (AUC = 0.86). The Epi proLung BL Reflex Assay® for determining the hypermethylation state of the SHOX2 gene in bronchoalveolar lavage samples by PCR had modest sensitivity (69%, 95% confidence interval [CI]: 64–75) and high specificity (96%, 95% CI: 97–100). A test in development for determining the hypermethylation state of BCAT1/CDO1/TRIM58/ZNF177 genes in aspirated or bronchoalveolar lavage samples by pyrosequencing yielded a sensitivity of 85 percent and a specificity of 81 percent, with an AUC of 0.91 at the optimal cutoff point. Conclusions The evidence for the three tests showed promising results in terms of diagnostic validity. However, although personalized medicine is becoming increasingly widespread in the field of cancer diagnosis, more studies are needed to evaluate the clinical utility of these diagnostic tests, either as a complementary or a screening test, and the economic impact of their use.

The aim of this study was to measure the use of mammography and the factors associated with testing among Spanish women, after the introduction of screening programmes in Spain. We conducted a cross-sectional population survey of a representative sample of women aged 40-70 (2409 women). Data collection took place in October 2000, using a questionnaire addressing the dependent variable (mammography use) and the independent variables (socio-demographic and socio-health factors, and women's knowledge and attitudes). Mammography use was defined as having received at least one screening test in the previous 2 years. Data analysis consisted of univariate and multivariate analyses. 48.1% (95% confidence interval (CI) 46.0-50.2) of women had received screening mammography. The main factors associated with testing were: mammography invitation from the screening programme (odds ratio (OR) 4.81; 95% CI 3.85-6.01); gynaecologist visit (OR 4.32; 95% CI 3.45-5.41); and intention to have a mammogram (OR 2.94; 95% CI 2.00-4.32). Other test-related factors were: not rejecting test for discomfort or fear of cancer; mammography perceived as necessary; age 56-65; upper/upper-middle socio-economic status. In conclusion, after the introduction of screening programmes, almost half of Spanish women aged 40-70 had received mammography. Invitation to screening, gynaecologist visit and women's attitudes are the main reasons for undergoing testing. Women over 65 years of age and/or those in a lower socio-economic level warrant special attention.

The screening mammography is the most highly effective procedure for early breast cancer detection. This study is aimed at ascertaining the differences in the factors related to Spanish women 40-70 years of age having had mammograms in 1994 and 2000 and among those having had at least one mammogram within the two years prior. Comparison of the results of two surveys conducted in 1994 and 2000, each on samples of women representative of Spanish women 40-70 years of age (3,218 in 1994 and 2,409 in 2000). An analysis was made of sociodemographic, sociosanitary and the women's attitude and awareness-related variables. Statistically significant differences were found between 1994 and 2000, the intention of having a mammogram in the future (96% in 2000 vs. 79% in 1994) (p<0.0001). A total of 59% of the 51-65 age group had a mammogram in 2000, as compared to the 50% who had one in 1994. The profile of Spanish women has undergone a change from 1994 to 2000, although those women who had had a mammogram were of similar sociodemographic and sociosanitary characteristics. However, the screening is being done to a greater extent on the age 51-65 age group in 2000, and the women are showing more positive attitudes toward having a mammogram.

The objective of this study was to measure use of mammography and associated factors among women living in Spanish provinces with breast cancer screening programmes. From a cross-sectional population survey in a representative sample of Spanish women aged 40–70 years, we selected all women aged 45–65 living in provinces with breast cancer screening programmes (336 women). The programmes invited women in this age group to have a mammogram every 2 years. Data were collected by oral interviews in 1994. Use of mammography was defined as having received at least one test in the previous 2 years. Factors associated with mammography were studied using a logistic regression model. In the three autonomous communities (totalling 11 provinces) with programmes, the percentage of women receiving the test was 41.1% in Castille-Leon, 41.7% in Castille-La Mancha and 87.6% in Navarre (mean: 55.4%). The programmes began in 1990 in Navarre and between 1992 and 1993 in the other two communities. The most important factors affecting mammography use in the multivariate analysis were: intention to have a mammogram [odds ratio (OR) = 5.52; 95% confidence interval (CI) = 3.17–9.63]; not rejecting the test for fear of cancer diagnosis (OR = 4.23; 95% CI = 1.64–10.9); and physician recommendation of the test (OR = 3.43; 95% CI = 1.88–6.24). In conclusion, although the more established screening programmes have higher mammography use than those more recently implemented, programmes alone may not guarantee that women receive the test. Women's attitudes about mammography, and the role of the physician, are fundamental factors in the use of mammography.

We studied availability to mammography among Spanish women aged 40 to 70 years, variation in use of the mammography by autonomous community, and the situation and importance of breast cancer screening programs among other factors, in the access to mammography. A cross-sectional population survey was conducted in 1994 in a sample of 3,218 women. A questionnaire was used to collect data on the variable access (receipt of at least one mammogram in the last 2 years) as well as different access-related variables. Information on breast cancer screening programs was collected by contacting the responsible institutions. We considered that a program had total coverage if it included all the municipalities in the province and partial if it did not include all municipalities. Twenty-eight percent of women had performed a mammogram. This proportion varied among autonomous communities (AACC) from 11.5 to 73.8%. Breast cancer screening programs existed in 8 AACC. The multivariant analysis revealed an association between access to mammography and the existence of a screening program, especially when the later had total coverage (OR = 7.64; 95% CI = 5.24-11.10). An association was also found between access to mammography and physician-related factors, place of residence and attitudes of women toward mammography. Less than one third of women aged 40-70 have performed a mammography in the last 2 years, and this proportion varies among AACC. Gynecologist visits and the existence of breast cancer screening programs are fundamental factors in the access to mammography in Spain.