Contribution of lymphoscintigraphy to intraoperative sentinel lymph node detection in early cervical cancer: Analysis of the prospective multicenter SENTICOL cohort.

PURPOSE: To evaluate the contribution of preoperative lymphoscintigraphy to intraoperative lymphatic mapping (ILM) in early cervical cancer METHODS: We conducted an ancillary analysis of the multicenter prospective SENTICOL study in early cervical cancer. Radiocolloid was injected intracervically on the day before (long protocol) or morning of (short protocol) surgery, lymphoscintigraphy was performed, and the results of a centralized image review were communicated to the surgeons. ILM was performed on combined radioactivity/patent blue detection. Sentinel lymph nodes (SLNs) were electively sampled before routine bilateral pelvic lymphadenectomy by laparoscopy. RESULTS: Of 139 patients in the modified intention-to-diagnose analysis, 114 had centrally reviewed lymphoscintigrams, which showed 352 SLNs in 100 patients. Lymphoscintigraphy and ILM detection rates were 87.8% and 97.8%, respectively. Agreement between lymphoscintigraphy and ILM was low for the number of SLNs (κ=0.23; -0.04; 0.49) and bilateral SLNs (κ=0.36; 0.2; 0.52). No patient without SLNs by ILM had SLNs by lymphoscintigraphy. Lymphoscintigraphy identified substantial proportions of unusual drainage pathways. No patients with metastatic nodes had SLNs by lymphoscintigraphy but not by ILM in the relevant territory. In 1 of the 2 patients with false-negative SLN results, SLNs were bilateral by lymphoscintigraphy and unilateral by ILM. CONCLUSION: Although the detection rate was lower by lymphoscintigraphy than by ILM, the substantial proportions of SLNs in unusual territories provided valuable guidance for the surgical exploration. Awareness of the limited agreement between lymphoscintigraphic and surgical detection might help surgeons decrease the false-negative rate.

Long-term follow-up of patients undergoing capsule and double-balloon enteroscopy for identification and treatment of small-bowel vascular lesions: a prospective, multicenter study.

BACKGROUND AND STUDY AIMS: Few data are available concerning the long-term outcome of patients treated endoscopically for bleeding small-bowel vascular lesions (SBVL). The aim of this study was to evaluate the risk of rebleeding after endoscopic therapy for SBVLs detected by video capsule enteroscopy (VCE). The secondary aim was to assess risk factors for rebleeding. PATIENTS AND METHODS: A prospective, multicenter study (15 centers) was conducted, involving patients with obscure gastrointestinal bleeding and SBVL on VCE who were treated during double-balloon enteroscopy (DBE). The likelihood of bleeding was defined according to VCE findings, as high or low. RESULTS: A total of 183 patients underwent endotherapy during DBE, and 64 (35 %) had rebleeding during the 1 year follow-up period. Multivariate analysis indicated that cardiac disease (hazard ratio [HR] 2.04, 95 % confidence interval [CI] 1.20 - 3.48; P < 0.01) and the presence of overt bleeding (HR 1.78, 95 %CI 1.07 - 2.97; P = 0.03) at presentation were associated with the risk of rebleeding. The association between chronic renal failure and the risk of rebleeding was close to statistical significance (HR 1.77, 95 %CI 0.94 - 3.33; P = 0.08). Kaplan-Meier analysis suggested that patients treated during DBE for a lesion with low likelihood of bleeding on VCE had higher rebleeding rates than those with a high likelihood of bleeding (HR 1.87, 95 %CI 0.94 - 3.37; P = 0.07). CONCLUSION: Despite long-term remission in most patients, about one-third had rebleeding at 1 year. Independent risk factors for rebleeding were cardiac disease and overt bleeding at original presentation. The lesion characteristics on VCE may be useful to evaluate the bleeding potential of the lesion and may be used for better selection of patients for DBE.

Diagnostic yield of capsule endoscopy in refractory celiac disease.

OBJECTIVES: Capsule endoscopy (CE) allows for the assessment of the small bowel in numerous intestinal diseases, including celiac disease (CD). The main advantage of CE is the complete visualization of the intestinal mucosal surface. The objective of this study was to investigate whether CE can predict the severity of CD and detect complications. METHODS: We retrospectively studied the medical files of 9 patients with symptomatic CD, 11 patients with refractory celiac disease type I (RCDI) and 18 patients with refractory celiac disease type II (RCDII), and 45 patients without CD who were investigated both CE and upper endoscopy or enteroscopy. The type of CD was diagnosed on the basis of a centralized histological review, flow cytometry analysis of intraepithelial lymphocytes, and the analysis of T-cell receptor rearrangement by multiplex polymerase chain reaction. RESULTS: A total of 47 CEs (10, 11, and 26 CEs in the symptomatic CD, RCDI, and RCDII groups, respectively) from the 38 celiac patients and 47 CEs from the 45 nonceliac patients were retrospectively reviewed. Villous atrophy, numerous, or distally located ulcers were more frequent in celiac patients than in controls. Among celiac patients, CE was of acceptable quality in 96% of cases and was complete in 62% of cases. The concordance of CE with histology for villous atrophy was better than that of optic endoscopy (κ coefficient =0.45 vs. 0.24, P<0.001). Extensive mucosal damage on CE was associated with low serum albumin (P=0.003) and the RCDII form (P=0.02). Three cases of overt lymphoma were detected by CE during the follow-up. CONCLUSIONS: CE findings have a satisfactory concordance with histology and nutritional status in patients with symptomatic or refractory CD. Moreover, CE may predict the type of RCD and allows for the early detection of overt lymphoma.

Treatment intensity, age and outcome in medical ICU patients: results of a French administrative database.

BACKGROUND: Intensive care unit (ICU) patients are aging, and older age has been associated with higher mortality in ICU. As previous studies have reported that older age was also associated with less intensive treatment, we investigated the relationship between age, treatment intensity and mortality in medical ICU patients. METHODS: Data were extracted from the administrative database of 18 medical ICUs. Patients with a unique medical ICU stay and a Simplified Acute Physiology Score II (without age-related points) >15 were included. Treatment intensity was described with a novel indicator, which is a four-group classification based upon the most frequent ICU procedures. The relationship between age, treatment intensity and hospital mortality was analyzed with the estimation of standardized mortality ratio in the four groups of treatment intensity. RESULTS: A total of 23,578 patients, including 3203 patients aged ≥80 years, were analyzed. Hospital mortality increased from 13 % for the younger patients (age < 40 years) to 38 % for the older patients (age ≥ 80 years), while Simplified Acute Physiology Score II (without age-related points) increased only from 36 (age < 40 years) to 43 (age ≥ 80). Hospital mortality increased with age in the four groups of treatment intensity. Standardized mortality ratio increased with age among the patients with less intensive treatment but was not associated with age among the patients with the highest treatment intensity. CONCLUSION: Our results support the fact that the increase in mortality with age among ICU patients is not related to an increase in severity. Using a new tool to estimate ICU treatment intensity, our study suggests that mortality of ICU patients increases with age whatever the treatment intensity is. Further investigations are required to determinate whether this increase in mortality among older ICU patients is related to undertreatment or to a lower efficiency of organ support treatment.

Nurse workload and inexperienced medical staff members are associated with seasonal peaks in severe adverse events in the adult medical intensive care unit: A seven-year prospective study.

OBJECTIVE: Our purpose was to identify potential organizational factors that contributed to life-threatening adverse events in adult intensive care unit. METHODS: A prospective, observational, dynamic cohort study was carried out from January 2006 to December 2013 in a 20-bed adult medical intensive care unit. All patients admitted to the intensive care unit and who experienced one or more selected life-threatening adverse events (mainly unexpected cardiac arrest, unplanned extubation, reintubation after planned extubation, and readmission within 48h of intensive care unit discharge) were included in the analysis. Negative binomial regression was used to model how human resources, work organization, and intensive care activity influenced the monthly rate of selected severe adverse events. Data were collected from local and national databases. RESULTS: Overall, 638 severe adverse events involving 498 patients were recorded. Adverse events increased seasonally in May, November and December (p<.001 vs other months). The proportion of inexperienced nurses and doctors' working hours could not explain these seasonal peaks of adverse events. Multivariate analysis identified bed-to-nurse ratio and the arrival of inexperienced residents or senior registrars as being independently associated with the rate of adverse events (incidence risk ratio=1.36 (95% confidence interval, 1.05-1.75), and 1.07 (95% confidence interval, 1.01-1.13), respectively; p=.01 in both cases). According to this model, a one-unit increase in the day-night shifts carried out by each nurse per month tended to reduce the rate of adverse events (incidence risk ratio=0.60 (95% confidence interval, 0.36-1.01), p=.05). Severity at intensive care unit admission did not influence the rate of adverse events (incidence risk ratio=1.02 (95% confidence interval, 1.00-1.04), p=.12). CONCLUSIONS: Results identify nurse workload and the arrival of inexperienced residents or senior registrars as risk factors for the occurrence of life-threatening adverse events in the adult medical intensive care unit. Limiting fluctuations in bed-to-nurse ratio and providing inexperienced medical staff members with sufficient supervision may decrease severe adverse events in critically ill patients.

A simulation study of the interception of prescribing errors by clinical pharmacists in an acute hospital setting.

RATIONALE, AIMS AND OBJECTIVES: To evaluate the performance of several pharmacists in the same department who analysed the same prescriptions in a simulation study. METHODS: One hundred prescriptions were retrospectively extracted from the prospective database of our hospital. Five clinical pharmacists working in the same department were asked to analyse individually the order lines of each prescription as if it were part of their routine daily practice. Afterward, an independent committee of five other clinical pharmacists reviewed the same 100 prescriptions. We calculated the sensitivity and the specificity of error detection in a line order by using the results of the committee as the gold standard. RESULTS: A total of 908 order lines were analysed (mean 9 ± 3 order lines per prescription). Fifty-one medication errors were identified by the committee (5.6%), including 23 related to laboratory test results: renal failure, or therapeutic concentrations being too low or too high. The sensitivity of the five pharmacists ranged between 19.6% and 56.9% and the specificity between 92.8% and 98.7%. The rates of agreement between each pharmacist and the committee, assessed using kappa coefficient, were between 0.20 and 0.39. The main factors affecting sensitivity and/or specificity in univariate analysis were the number of drugs per prescription, type of drug prescribed (ATC classification) and the glomerular filtration rate. CONCLUSION: Discrepancies between the performances of pharmacists exist, as there are between other health care professionals. Pharmacist training, standardization of the pharmaceutical analysis of drug prescription, and implementation of a clinical decision support system allowing biological values to be linked to drug prescriptions could improve individual performance.

How Drug Use by French Elderly Patients Has Changed During the Last Decade.

BACKGROUND: In France the most recent data on drug use by the elderly living at home were published in 2000. Since then the available drugs and their use have changed. OBJECTIVE: We compared data collected in 2011 with the 2000 data to evaluate how drug use has changed in France. METHODS: The study analysed retrospectively the 2011 data collected prospectively in France from a sample of 600,000 people representative (1/97th) of the French population. All prescribed drugs reimbursed by the French national health insurance were recorded. Due to the reimbursement procedure the unit of analysis was the trimester. The drugs were coded using the Anatomical Therapeutic Chemical (ATC) Classification System. RESULTS: Data from 580,989 patients were analysed (133,411 (23.0 %) aged ≥60 years, 32,314 (5.6 %) ≥80 years). The percentage of patients who used medication increased from 55.9 % for patients in their fourth decade to 88.6 % for patients in their eighth decade, remained stable till 90 years of age and decreased to 26.3 % in centenarians. The median number of drugs prescribed was five (IQR: 3-8) in those aged under 80 years and ten (IQR: 7-14) in those aged over 80 years. Cardiovascular drugs were the most used, by 70.9, 78.1, and 69.6 % of patients aged 70-79, 80-89, and 90-99 years, respectively. Analgesics, non-steroidal anti-inflammatory drugs, and antibiotics were prescribed in almost half of the patients. CONCLUSION: Polypharmacy is common among the elderly in France. Although this may be explained by the multiple co-morbidities, our results suggest an overuse of drugs for which the risk-benefit ratio is unknown in these age ranges. Consequently, numerous elderly patients are exposed to iatrogenic risks without the certainty of therapeutic benefits.

Feasibility and performance of lymphoscintigraphy in sentinel lymph node biopsy for early cervical cancer: results of the prospective multicenter SENTICOL study.

OBJECTIVE: To evaluate feasibility, SLN detection rate, and SLN location of lymphoscintigraphy in sentinel lymph node (SLN) biopsy for early cervical cancer. METHODS: Ancillary analysis of data from the multicenter prospective SENTICOL study (January 2005-June 2007) of patients with early cervical cancer (FIGO stage IA with emboli to IB1) was conducted. Preoperative lymphoscintigraphy was performed after intracervical administration of 60 or 120 MBq of (99m)Tc-labeled radiocolloid on the day before (long protocol) or morning of (short protocol) surgery. SLNs were identified intraoperatively using combined radioactivity/patent blue detection. SLNs were sampled electively and routine bilateral pelvic lymphadenectomy was performed by laparoscopy. A centralized review of lymphoscintigraphies was performed to assess feasibility, detection rates, and anatomic SLN location. RESULTS: Of 139 patients included in the SENTICOL study, 133 received radiocolloid injection, and 131 (98.5 %) underwent preoperative lymphoscintigraphy, with the long protocol in three-fourths of cases. The lymphoscintigraphic detection rate was 87.8 %, with a median of 2 (1-4) SLNs per patient. By multivariate analysis, factors independently associated with lymphoscintigraphic SLN detection were age [odds ratio (OR) 0.91, 95 % confidence interval (95 % CI) 0.87-0.96; P < 0.001], and protocol (long vs. short; OR 8.23, 95 % CI 1.87-36.25; P = 0.005). Bilateral SLN identification by lymphoscintigraphy occurred in 67 % of cases and was independently influenced by age (OR 0.95, 95 % CI 0.92-0.98, P < 0.001) and protocol (OR 5.42, 95 % CI 2.21-13.27; P < 0.001). Although 60.5 % of preoperative SLNs were in the external iliac territory, unusual drainage patterns included the common iliac (19.6 %), para-aortic (10.8 %), and parametrial (6 %) basins. CONCLUSIONS: Our study demonstrates the feasibility and good detection rate of preoperative lymphoscintigraphy, with better detection in younger patients and with the long protocol. The high proportion of SLN basins in unexpected territories is of interest to guide intraoperative detection. Further studies are needed to better evaluate preoperative detection and to assess the contribution of lymphoscintigraphy to intraoperative detection.

Validation of a French version of the 8-item Morisky medication adherence scale in hypertensive adults.

The aim of this study was to validate a French translation of the structured self-report 8-item Morisky Medication Adherence Scale (MMAS-8) and determine its psychometric properties in patients taking antihypertensive medication. An observational cross-sectional study was conducted in the hypertensive unit of a French university hospital. The MMAS-8 was translated according to international guidelines. Internal consistency was assessed using Cronbach α coefficient, construct validity using principal component and confirmatory factor analyses, and the test-retest reliability at 1-month interval using the intraclass correlation coefficient (ICC). Three levels of adherence were considered (low: scores of 0 to <6; medium: 6 to <8; high: 8) and risk factors were explored in ordinal logistic regression models. A total of 199 patients were included: mean age, 55.7±14.6 years, 57.3% men (114 of 199), and 39.5% (66 of 167) had uncontrolled blood pressure. The French MMAS was moderately reliable (α=0.54), one-dimensional, and reproducible (ICC=0.68). The mean score was 6.96 (standard deviation 1.25) and 17.6% (35 of 199), 37.7% (75 of 199), and 43.7% (87 of 199) of patients had low, medium, and high adherence, respectively. The only factor significantly associated with adherence was age. The French MMAS has acceptable psychometric effects to measure medication adherence in hypertensive patients and may be useful in detecting nonadherent hypertensive patients.