[Validation of the short FES-I scale in Spanish population over 70 years]. / Validación de la escala Short FES-I en población española mayor de 70 años.

INTRODUCTION: Falls deteriorate the quality of life of the elderly and the fear of falling has been shown to be an independent risk factor for frailty, so having tools for its evaluation is a priority. The short FES-I scale, short version (7 items) of the FES-I scale (16 items), assesses fear of falling. The objective of this study is to validate the short FES-I scale in the Spanish population over 70 years and to analyze the relationship between fear of falling, risk of falls and frailty. MATERIAL AND METHODS: Cross-sectional observational study. SAMPLE: 227 subjects (50.7% male; mean age 75.8 years). SETTING: northern Spain. VARIABLES: sociodemographic, clinical, short physical performance battery (SPPB) and timed up and go test (TUG) execution tests, FES-I and short FES-I. Analysis of psychometric properties: validity and reliability. RESULTS: The short FES-I scale shows excellent internal consistency (Cronbach's alpha = 0.90, intraclass correlation coefficient = 0.89) and test-retest reliability (rho Spearman = 0.76). It has a high concomitant criterion validity analyzed by its correlation with FES-I (rho Spearman = 0.90). The discriminant construct validity has been confirmed for both SPPB and TUG. Short FES-I presents good capacity for frailty classification (defined by SPPB) with AUC = 0.715. As a cut-off point, a short FES-I value > 8 is proposed for moderate/high fear of falling. CONCLUSIONS: The short FES-I scale is a good instrument to study fear of falling in the Spanish population over 70 years and is valid for clinical and research use.

Immunogenicity of COVID-19 vaccines in lung cancer patients.

OBJECTIVE: Patients with lung cancer are at increased risk of SARS-CoV-2 infection and severe complications from COVID-19, but information on the efficacy of anti-SARS-CoV-2 vaccine in these patients is scarce. We aimed at evaluating the safety and immunogenicity of COVID-19 vaccines in this population. PATIENTS AND METHODS: The prospective, nationwide SOLID substudy, enrolled adults with lung cancer who were fully vaccinated against COVID-19. Serum anti-SARS-CoV-2 IgG antibody levels were quantitatively assessed two weeks and six months after receipt of the last dose using a chemiluminescent microparticle immunoassay. Multivariate odds ratios for the association between demographic and clinical factors and seronegativity after vaccination were estimated. RESULTS: 1973 lung cancer patients were enrolled. Most patients had stage IV disease (66%) and were receiving active cancer treatment (82.7%). No significant differences were found in the probability of being seronegative for anti-SARS-CoV-2 IgG antibodies after full vaccination between patients who were receiving active cancer treatment and those who were not (p = 0.396). The administration of immunotherapy or oral targeted therapy and immunization with mRNA-1273 COVID-19 vaccine were factors independently associated with increased odds of being seropositive after vaccination. From all patients, 1405 received the second dose of vaccine and high levels of antibody titers were observed in 93.6% of patients two weeks after second dose. At six months, multivariate logistic regression analysis showed that performance status ≥ 2 was independently associated with a higher probability of being seronegative after full vaccination with an OR 4.15. On the other hand, received chemotherapy or oral target therapy and vaccination with mRNA-1273 were a factor independently associated with lower odds of being seronegative after full vaccination with an OR 0.52, 0.37 and 0.34, respectively. CONCLUSIONS: Lung cancer patients can safely achieve a strong immune response against SARS-CoV-2 after full vaccination, regardless of the cancer treatment received. TRIAL REGISTRATION: NCT04407143.

Alectinib after failure to crizotinib in patients with ALK-positive non-small cell lung cancer: results from the Spanish early access program.

This retrospective observational study analyzed the clinical characteristics, treatment patterns and outcomes of 120 patients with advanced ALK-positive non-small-cell lung cancer (ALK+ NSCLC) according to data collected between November 2019 and October 2020 in 38 Spanish hospitals. Patients had progressed after 1-5 prior treatment lines (which included crizotinib in any prior line) and received subsequent therapy with alectinib in a local expanded access program. Median age was 58.7 years, 50% of patients were female, 64.1% had ECOG PS of 0-1, 85% presented stage IV, 95% had adenocarcinoma histology and 20.8% had brain metastases. After a median 9.6 months of alectinib treatment, objective response rate (ORR) was 54.5%, disease control rate (DCR) was 80%, median progression-free survival (PFS) was 9.4 months and median overall survival (OS) was 24.1 months. Patients with brain metastases achieved an intracranial DCR of 71.4%. Adverse events (AEs) were reported in 35.8% of patients (14.2% of AEs were grade ≥3). Over 40% of patients received some treatment after alectinib, most frequently lorlatinib (65.2%) and brigatinib (32.6%). This study provides information on real-world treatment patterns and confirms the tolerability and prolonged PFS and OS observed with alectinib in clinical trials, in unselected pretreated patients with advanced ALK+ NSCLC.

Lung cancer patients with COVID-19 in Spain: GRAVID study.

INTRODUCTION: Patients with cancer may be at increased risk of more severe COVID-19 disease; however, prognostic factors are not yet clearly identified. The GRAVID study aimed to describe clinical characteristics, outcomes, and predictors of poor outcome in patients with lung cancer and COVID-19. METHODS: Prospective observational study that included medical records of patients with lung cancer and PCR-confirmed COVID-19 diagnosis across 65 Spanish hospitals. The primary endpoint was all-cause mortality; secondary endpoints were hospitalization and admission to intensive care units (ICU). RESULTS: A total of 447 patients with a mean age of 67.1 ± 9.8 years were analysed. The majority were men (74.3 %) and current/former smokers (85.7 %). NSCLC was the most frequent type of cancer (84.5 %), mainly as adenocarcinoma (51.0 %), and stage III metastatic or unresectable disease (79.2 %). Nearly 60 % of patients were receiving anticancer treatment, mostly first-line chemotherapy. Overall, 350 (78.3 %) patients were hospitalized for a mean of 13.4 ± 11.4 days, 9 (2.0 %) were admitted to ICU and 146 (32.7 %) died. Advanced disease and the use of corticosteroids to treat COVID-19 during hospitalization were predictors of mortality. Hospitalized, non-end-of-life stage patients with lymphocytopenia and high LDH had an increased risk of death. Severity of COVID-19 correlated to higher mortality, ICU admission, and mechanical ventilation rates. CONCLUSIONS: Mortality rate was higher among patients treated with corticosteroids during hospitalization, while anticancer therapy was not associated with an increased risk of hospitalization or death. Tailored approaches are warranted to ensure effective cancer management while minimizing the risk of exposure to SARS-CoV-2.

Osimertinib in advanced EGFR-T790M mutation-positive non-small cell lung cancer patients treated within the Special Use Medication Program in Spain: OSIREX-Spanish Lung Cancer Group.

BACKGROUND: AURA study reported 61% objective response rate and progression-free survival of 9.6 months with osimertinib in patients with EGFR/T790M+ non-small cell lung cancer. Due to lack of real-world data, we proposed this study to describe the experience with osimertinib in Spain. METHODS: Post-authorization, non-interventional Special Use Medication Program, multicenter, retrospective study in advanced EGFR/T790M+ non-small cell lung cancer. One hundred-fifty five patients were enrolled (August 2016-December 2018) from 30 sites. PRIMARY OBJECTIVE: progression-free survival. Secondary objectives: toxicity profile, objective response rate, and use of health service resources. RESULTS: 70% women, median age 66. 63.9% were non-smokers and 99% had adenocarcinoma. Most patients had received at least one prior treatment (97%), 91.7% had received previous EGFR-tyrosine kinase inhibitors and 2.8% osimertinib as first-line treatment. At data cutoff, median follow-up was 11.8 months. One hundred-fifty five patients were evaluable for response, 1.3% complete response, 40.6% partial response, 31% stable disease and 11.6% disease progression. Objective response rate was 42%. Median progression-free survival was 9.4 months. Of the 155 patients who received treatment, 76 (49%) did not reported any adverse event, 51% presented some adverse event, most of which were grade 1 or 2. The resource cost study indicates early use is warranted. CONCLUSION: This study to assess the real-world clinical impact of osimertinib showed high drug activity in pretreated advanced EGFR/T790M+ non-small cell lung cancer, with manageable adverse events. TRIAL REGISTRATION: Clinical trial registration number: NCT03790397 .

Comprehensive cross-platform comparison of methods for non-invasive EGFR mutation testing: results of the RING observational trial.

Several platforms for noninvasive EGFR testing are currently used in the clinical setting with sensitivities ranging from 30% to 100%. Prospective studies evaluating agreement and sources for discordant results remain lacking. Herein, seven methodologies including two next-generation sequencing (NGS)-based methods, three high-sensitivity PCR-based platforms, and two FDA-approved methods were compared using 72 plasma samples, from EGFR-mutant non-small-cell lung cancer (NSCLC) patients progressing on a first-line tyrosine kinase inhibitor (TKI). NGS platforms as well as high-sensitivity PCR-based methodologies showed excellent agreement for EGFR-sensitizing mutations (K = 0.80-0.89) and substantial agreement for T790M testing (K = 0.77 and 0.68, respectively). Mutant allele frequencies (MAFs) obtained by different quantitative methods showed an excellent reproducibility (intraclass correlation coefficients 0.86-0.98). Among other technical factors, discordant calls mostly occurred at mutant allele frequencies (MAFs) ≤ 0.5%. Agreement significantly improved when discarding samples with MAF ≤ 0.5%. EGFR mutations were detected at significantly lower MAFs in patients with brain metastases, suggesting that these patients risk for a false-positive result. Our results support the use of liquid biopsies for noninvasive EGFR testing and highlight the need to systematically report MAFs.

ASTRIS, a large real-world study to evaluate the efficacy of osimertinib in epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer patients: Clinical characteristics and genotyping methods in a Spanish cohort.

PURPOSE: Osimertinib has proven efficacy in EGFR T790M mutation-positive non-small cell lung cancer (NSCLC) patients; however, its benefits have not been evaluated in a real-world setting. METHODS: ASTRIS is a single-arm, open-label, multinational study to evaluate the efficacy and safety of osimertinib for the treatment of EGFR T790M mutation-positive NSCLC. We present the study design and preliminary cut-off analysis results (as of October 2017) describing the baseline characteristics and methodology for T790M mutation detection in the Spanish cohort. RESULTS: The Spanish cohort included 131 patients from a total 3014 patients. Forty patients (28.1%) were still undergoing therapy at the time of cut-off; 68.7% were women and 97.7% were Caucasian, with a mean age of 64.8 (SD 11.7) years. The most common type of sample for evaluating T790M mutations was tissue (55.0%), and samples were obtained from the primary tumor in 61.1% of cases. Mutation analysis was performed by the local laboratory in 60.3% of cases and using the Roche Cobas® EGFR assay in 43.5% of cases. CONCLUSIONS: ASTRIS is expected to confirm the benefits of osimertinib in a real-world setting. Data on real-world practices for the detection of the EGFR T790M mutation may provide additional information for the designing of guidelines for best practices.

Prognostic factors that modify outcomes of vestibular rehabilitation in elderly patients with falls.

BACKGROUND: Our previous study has shown that vestibular rehabilitation (VR) is an effective technique to reduce falls in elderly patients. It would be interesting to establish patients' clinical characteristics in which vestibular rehabilitation is expected to be more effective. AIMS: Evaluate factors that could modify rehabilitation outcomes in elderly patients with previous falls. METHODS: Fifty-seven patients randomized to one of the intervention group (computerized dynamic posturography-CDP-training, optokinetic stimulus or exercise at home) and with previous falls were analyzed. Patients were assessed with objective outcome measures (sensorial organization test and limits of stability-LOS-of CDP, modified timed up and go test-TUG-and number of falls) and with subjective outcome measures (dizziness handicap inventory and Short falls efficacy scale-international-Short FES-I) during a 12-month follow-up period. RESULTS: In the logistic regression model, a worse score in the maximum excursion (MXM), and a shorter time in the TUG significantly associated with a reduction > 50% of falls. Also, association with a higher score in the Short FES-I was close to a statistical significance. There was no statistical significance association with other covariables. DISCUSSION: In patients with reduced limits of stability, VR seems to be more effective and they should be encouraged to perform it. But on the other hand, patients with longer time in the TUG show worse outcomes and may benefit more with gait training. CONCLUSIONS: VR in elderly people with previous falls is effective regardless of their age and gender.

Oral vinorelbine versus etoposide with cisplatin and chemo-radiation as treatment in patients with stage III non-small cell lung cancer: A randomized phase II (RENO study).

OBJECTIVES: Concomitant chemo-radiation is the standard treatment for unresectable stage III non-small cell lung cancer (LA-NSCLC). The aim of this study was to assess the safety and efficacy of oral vinorelbine and cisplatin (OVP) compared with etoposide and cisplatin (EP), both in combination with radiotherapy, in this setting. MATERIAL AND METHODS: An open-label, randomized phase II trial was undertaken including 23 hospitals in Spain. Adults with untreated unresectable stage III NSCLC were randomized1:1 to receive: oral vinorelbine (days 1 and 8 with cisplatin on day 1 in 3-week cycles; 2 cycles of induction, 2 cycles in concomitance) or etoposide (days 1-5 and 29-32 with cisplatin on days 1 and 8 in 4-week cycles; 2 cycles in concomitance). Both groups received concomitant radiotherapy 2 Gy/day (66 Gy). The primary endpoint was progression free survival (PFS). RESULTS: One hundred and forty patients were enrolled. Sixty-nine patients received OVP and 71 received EP. Globally adverse events grade 3/4 per cycle were fewer in the vinorelbine arm (19.4%) than in the etoposide arm (62.6%) (p < 0.001). One patient (1.5%) in the OVP arm and 12 pts (17.6%) in the EP arm presented esophagitis grade 3/4 (p = 0.002). Median PFS was similar in both groups (10.8 [95% CI 7.7-13.8] and 9.6 months [95% CI 4.4-14.8]; p = 0.457, respectively). Preliminary median overall survival was 30 months in the OVP arm and 31.9 months in the EP arm (p = 0.688). CONCLUSIONS: Our findings show that OVP could be considered a standard combination with similar efficacy and better safety profile for the treatment of LA-NSCLC patients.

Optimising costs in reducing rate of falls in older people with the improvement of balance by means of vestibular rehabilitation (ReFOVeRe study): a randomized controlled trial comparing computerised dynamic posturography vs mobile vibrotactile posturography system.

BACKGROUND: Accidental falls, especially for the elderly, are a major health issue. Balance disorders are one of their main causes. Vestibular rehabilitation (VR) has proven to be useful in improving balance of elderly patients with instability. Its major handicap is probably its cost, which has prevented its generalisation. So, we have designed a clinical trial with posturographic VR, to assess the optimum number of sessions necessary for a substantial improvement and to compare computerised dynamic posturography (CDP) (visual feedback) and mobile posturography (vibrotactile feedback). METHODS: Design: randomized controlled trial. It is an experimental study, single-center, open, randomized (balanced blocks of patients) in four branches in parallel, in 220 elderly patients with high risk of falls; follow-up period: twelve months. SETTING: Department of Otorhinolaryngology of a tertiary referral hospital. PARTICIPANTS: people over 65 years, fulfilling two or more of the following requirements: a) at least one fall in the last twelve months. b) take at least 16 s or require some support in perform the "timed up and go" test. c) a percentage of average balance in the sensory organization test (SOT) of the CDP < 68%. d) at least one fall in any of the conditions in SOT-CDP. e) a score in Vertiguard's gSBDT > 60%. INTERVENTION: Four differents protocols of vestibular rehabilitation (randomization of the patients). MAIN OUTCOME MEASURE: The percentage of average balance in the SOT-CDP. Secondary measures: time and supports in the "timed up and go" test, scores of the CDP and Vertiguard, and rate of falls. DISCUSSION: Posturographic VR has been proven to be useful for improving balance and reducing the number of falls among the aged. However, its elevated cost has limited its use. It is possible to implement two strategies that improve the cost-benefit of posturography. The first involves optimising the number of rehabilitation sessions; the second is based on the use of cheaper posturography systems. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03034655. Registered on 25 January 2017.

Vestibular rehabilitation in elderly patients with postural instability: reducing the number of falls-a randomized clinical trial.

BACKGROUND: Our previous study had shown the effectiveness of vestibular rehabilitation (VR) in improving balance in elderly patients, assessed immediately afterwards. AIMS: The main goal of the present study is to consider whether this improvement in balance assessment turns out in a reduction of the number of falls. METHODS: 139 elderly patients with high risk of falls were included and randomized to one of the following study arms: computerized dynamic posturography (CDP) training, optokinetic stimulus, exercises at home or control group. Patients were assessed with objective outcome measures (sensorial organization test and limits of stability of CDP, number of falls and number of hospital admissions due to falls) and subjective outcome measures (dizziness handicap inventory and short falls efficacy scale-international) during a 12-month follow-up period. RESULTS: Average number of falls significantly declined from 10.96 (before VR) to 3.03 (12-month follow-up) in the intervention group (p < 0.001); meanwhile, in the control group, the average number of falls changed from 3.36 to 2.61 during a 12-month follow-up period (p = 0.166). DISCUSSION: The present study provides evidence that VR can decisively improve balance in elderly patients with instability, which can lead in turn to a significant reduction of falls. CONCLUSION: We recommend performing VR in any older person with high risk of falls.

Clinical management and outcome of patients with advanced NSCLC carrying EGFR mutations in Spain.

BACKGROUND: Although the benefit of first-line epidermal growth factor receptor (EGFR) tyrosine-kinase inhibitors (TKIs) over chemotherapy has been demonstrated in several clinical trials, data from clinical practice is lacking and the optimal EGFR TKI to be used remains unclear. This study aims to assess the real-life diagnostic and clinical management and outcome of patients with advanced non-small-cell lung cancer (NSCLC) carrying EGFR mutations in Spain. METHODS: All consecutive patients recently diagnosed with advanced or metastatic NSCLC from April 2010 to December 2011 in 18 Spanish hospitals and carrying EGFR mutations were retrospectively evaluated. RESULTS: Between March and November 2013, a total of 187 patients were enrolled (98.3% Caucasian, 61.9% female, 54.9% never-smokers, 89.0% adenocarcinoma). Mutation testing was mainly performed on biopsy tumour tissue specimens (69.0%) using a qPCR-based test (90%) (47.0% Therascreen EGFR PCR Kit). Common sensitising mutations were detected in 79.8% of patients: 57.1% had exon 19 deletions and 22.6% exon 21 L858R point mutations. The vast majority of patients received first-line therapy (n = 168; 92.8%). EGFR TKIs were the most commonly used first-line treatment (81.5%), while chemotherapy was more frequently administered as a second- and third-line option (51.9% and 56.0%, respectively). Of 141 patients who experienced disease progression, 79 (56.0%) received second-line treatment. After disease progression on first-line TKIs (n = 112), 33.9% received chemotherapy, 8.9% chemotherapy and a TKI, and 9.8% continued TKI therapy. Most patients received first-line gefitinib (83.0%), while erlotinib was more frequently used in the second-line setting (83.0%). Progression-free survival (PFS) and overall survival (OS) in patients harbouring common mutations were 11.1 months and 20.1 months respectively (exon 19 deletions: 12.4 and 21.4 months; L858R: 8.3 and 14.5 months), and 3.9 months and 11.1 months respectively for those with rare mutations. CONCLUSION: EGFR TKIs (gefitinib and erlotinib) are used as the preferred first-line treatment while chemotherapy is more frequently administered as a second- and third-line option in routine clinical practice in Spain. In addition, efficacy data obtained in the real-life setting seem to concur with data from EGFR TKI phase III pivotal studies in NSCLC.

Short-term effectiveness of vestibular rehabilitation in elderly patients with postural instability: a randomized clinical trial.

Balance becomes more precarious with age, and even without pathological disorders, the physiological decline in balance that occurs with age is a factor that also favors falls. So the aim of the present study is to assess the short-term effectiveness of three different methods of vestibular rehabilitation, compared to a control group, in improving balance in elderly patients with postural instability. 139 elderly patients with high risk of falls were included and randomized to one of the following study arms: computer dynamic posturography (CDP) training, optokinetic stimulus, exercises at home, or control group. Patients were assessed with objective and subjective outcome measures. The individuals that trained using CDP improved significantly more than the control group on the average balance score (p < 0.001) and reducing the number of falls in the sensorial organization test (p < 0.001). In addition, the analysis showed a statistically significant effect in the limits of stability only with the CDP training in comparison with the control group (p < 0.001). In our present study, supervised and customized exercises with CDP were more effective than the control group in the posturographic short-term assessment. An increased age did not affect the potential for improvement after training. So we conclude that elderly patients with high risk of falling should begin vestibular rehabilitation as soon as possible in order to avoid the potential harm of falls, mainly injuries and psychological consequences due to fear of falling again.

Balance Disorders in the Elderly: Does Instability Increase Over Time?

OBJECTIVES: To analyze the equilibriometric differences between 2 populations of elderly patients (young elderly and very elderly) with instability induced solely by age. METHODS: Cross-sectional study, with 2 study groups classified according to patient age (cut-points in twenty-fifth and seventy-fifth percentiles of the age of the sample). POPULATION: 64 patients aged 65 years or more. Two groups of 32 subjects were established: group A (people 65 years of age or older but less than 72.6, twenty-fifth percentile) and group B (patients 82.5 years, seventh-fifth percentile, or older). Main analyzed variables: timed up-and-go test, sensory organization test of the computerized dynamic posturography, Dizziness Handicap Inventory (DHI), and Short Falls Efficacy Scale-International (FES-I) questionnaires. Student's t test or the Mann-Whitney test were used. RESULTS: The older patients obtain poorer scores in the equilibriometric tests but not in all of them. In the sensory organization test, the older patients make poorer use of visual and vestibular information; they also require more time and steps for the timed up-and-go. With regards to the questionnaires, fear of falling is greater (higher Short FES-I scores) but not subjective perception of disability (DHI scores without differences). CONCLUSIONS: There is a need to establish aged subgroups of elderly patients with instability, adapting therapeutic strategies.

Is there a relationship between short FES-I test scores and objective assessment of balance in the older people with age-induced instability?

Fear of falling (FOF) is a common problem among the elderly. The purpose of this study is to evaluate whether there is a correlation between FOF, estimated via the short FES-I test, and objective evaluation of balance in a group of elderly patients with age-related instability. The balance of 139 subjects of more than 65 years of age is evaluated by the timed up and go test and the computerised dynamic posturography (CDP). Different groups of elderly patients were established according to the number of falls in the previous 12 months, and the correlation with short FES-I test scores was evaluated. Based on the results, ROC curves were calculated. The short FES-I test presents a good capacity to distinguish between subjects with ≤ 3 falls/year and subjects with ≥ 4 falls/year (AUC 0.719, 95%CI 0.627-0.810). A test score of 14.5 is the best cut-off point (74% sensitivity, 51% specificity). Using this cut-off point, the study sample comprises two groups: subjects with test scores of 7-14 vs 15-28, with the first group obtaining best results with statistical significance (Student's t-test and the Mann-Whitney test) in most of the balance tests. The short FES-I is an excellent instrument that measures FOF in the elderly, and it is correlated with their number of falls both in real life and on the CDP. It is simple and fast, and so can be considered an extraordinary screening test relative to real risk of falls in the elderly.

Impact of obesity in elderly patients with postural instability.

OBJECTIVE: The aim of the study is to assess whether obesity affects balance in elderly patients with postural instability. STUDY DESIGN: It is a case-control study, with cases defined by BMI ≥30 kg/m(2), and developed in a third level university hospital. METHODS: We included 135 patients aged 65 years old or more who presented postural instability. Balance assessment was through the sensory organisation test (SOT), limits of stability (LOS) and rhythmic weight shift (RWS) of computerised dynamic posturography (CDP) and the modified timed up-and-go (TUG) test. The patients also completed the Dizziness Handicap Inventory and short Falls Efficacy Scale-International questionnaire. RESULTS: Patients with obesity took longer to perform the modified TUG and required more steps. Also these patients had poorer scores in the subjective tests. In the CDP there were no significant differences in the SOT nor the LOS, and only there was a statistical significant difference in the anterior-posterior directional control of the RWS. Obese patients have a higher risk of fallings compared to non-obese patients. CONCLUSION: In essence, our results indicate that obesity interferes in the balance of elderly patients with postural instability, putting them at a greater risk of fallings, performing worse dynamic tasks and feeling more disabled. Although continued education on training balance may be useful in older population, since the obese group shows more rate of fallers, rehabilitation programmes focus on dynamic tasks in these patients could be useful to reduce their fall risk and improve their quality of life.

Disability perception in Menière's disease: when, how much and why?

The purpose of the study was to evaluate self-perceived handicap in patients with definite Menière's disease (MD). A cross-sectional study was conducted. To examine the self-perception of disability, participants completed a DHI (Dizziness Handicap Inventory). Parameters compared with DHI scores: sex, age, unilateral/bilateral affectation, time elapsed since the onset of symptoms, pure-tone average (PTA), stages of MD, audiometric change (last 6 months), PTA in low frequencies (PTAl) and audiometric change in PTAl, subjective perception of fluctuating hearing threshold, tinnitus between attacks, number of vertiginous episodes (last 6 months), time elapsed since last attack, subjective perception of instability intercrises and Tumarkin attacks. 90 patients were included; they completed a total of 104 questionnaires. DHI scores ranged from 2 to 100 (average: 47.08, SD 24.45). In 29 cases (27.9 %) the disability perception was mild, in 43 (41.3 %) moderate, and in 32 (30.8 %) severe. Correlation between disability perception and some vestibular symptoms was found: number of typical attacks (last 6 months), time elapsed since last attack, instability intercrises and Tumarkin attacks. No relationship was found with the rest of variables. Disability perception in patients with MD depends primarily on vestibular symptoms (particularly, instability and frequency of attacks). So, we suggest to design a new staging system of MD taking into account both auditory criteria and also vestibular symptoms.

Assessment of morbidity in gynaecologic oncology laparoscopy and identification of possible risk factors.

BACKGROUND: The aim of this study was to ascertain the incidence of and the risk factors associated with morbidity in laparoscopy performed on patients with cervical cancer and endometrial cancer. METHODS: This was an observational study of a cohort of 128 women, 89 with endometrial cancer and 39 with cervical cancer from January 2000 to December 2011. We used the Student's t-test or the Mann-Whitney U test for continuous variables, and the Chi-square or Fisher's exact test for categorical variables. RESULTS: Complications were found in 44 patients (34.4%). After a multivariate analysis, among the risk factors associated with the presence of complications as the only type of surgery was found to be statistically significant (p = 0.043), more frequent in the most complex procedures such as Wertheim operation, trachelectomy, and para-aortic lymphadenectomy. Type of surgery (p = 0.003) and tumour type (p = 0.003) were risk factors associated with conversion to laparotomy. It was more frequent among the most complex procedures and cervical cancer cases. Regarding the need for transfusion, significant differences were observed in terms of surgery duration (p < 0.001), more frequent in longer surgery. CONCLUSION: Morbidity in laparoscopic surgical oncology is related to the surgery complexity, where the basal characteristics of the patient are not a factor of influence in the development of complications.

Reduction of falls in older people by improving balance with vestibular rehabilitation (ReFOVeRe study): design and methods.

MAIN OBJECTIVE: Evaluate the effectiveness of vestibular rehabilitation (VR) to improve the balance in older people, assessed immediately afterwards. SECONDARY OBJECTIVES: (a) To verify the maintenance of improvement of the balance achieved in the medium term (6-12 months). (b) To consider whether this improvement results in a reduction in the number of falls. (c) To compare among themselves the effectiveness of three different methods of VR in improving balance and to explore whether there are differences to achieve a reduction in the number of falls. DESIGN: Experimental study, single-centre, open, randomised (balanced blocks of patients) in four branches in parallel, in 220 elderly patients (over 64 years) with high risk of falls and a follow-up period of 12 months. SETTING: Department of Otolaryngology of the University Hospital of Santiago. PARTICIPANTS: People over 64 years, fulfilling one of the following requirements: (a) At least one fall in the last year. (b) Take at least 16 s or require some support in perform the test "timed up and go". (c) A percentage of average balance in the sensory organisation test (SOT) in the dynamic posturography (CDP) <68%. (d) At least one fall in any of the conditions in the SOT of CDP. INTERVENTION: Three different protocols of VR. MAIN OUTCOME MEASURE: The percentage of average balance in the SOT in CDP. Secondary measures: time and supports in the test of "timed up and go", scores of the dynamic posturography and SwayStar system, and rate of falls.