The transradial approach is increasingly used for percutaneous coronary intervention (PCI), and we therefore aimed to compare the clinical outcomes after transradial intervention (TRI) and transfemoral intervention (TFI) in all patients undergoing PCI. Among 6,973 patients enrolled in a nationwide, prospective, multicenter registry (February 2013 to September 2013), 1,860 underwent TRI (n = 1,445, 77.7%) and TFI (n = 415, 22.3%). Bleeding and major adverse cardiac events (MACE; death, myocardial infarction, revascularization, or stent thrombosis) were compared. Bleeding occurred in 42 patients (2.3%) and was significantly less likely in the TRI versus TFI group (overall cohort: 1.5% vs 4.8%, p = 0.001; propensity score-matched: n = 728, 2.7% vs 5.2%, p = 0.048). Multivariate regression revealed that TRI was negatively associated with bleeding (odds ratio 0.42, 95% CI 0.21 to 0.83, p = 0.013). MACE occurred in 152 patients (8.2%). Kaplan-Meier estimates showed higher MACE-free survival rates in the TRI versus TFI group (overall cohort: 93.3% vs 86.7%, log-rank p = 0.026; propensity score-matched: 91.8% vs 86.5%, log-rank p = 0.04). Cox proportional analysis demonstrated that TRI independently predicted improved MACE (hazard ratio 0.64, 95% CI 0.43 to 0.91, p = 0.024). In conclusion, TRI is associated with reduced bleeding rates and better clinical outcomes than TFI in all patients undergoing PCI.

The objective of the study was to determine growth performance, viscera organ development, economic benefit and sensory characteristics of meat from broilers finished on Acacia anguistissima leaf meal-based diets. One hundred and eighty Cobb 500-day-old chicks were used in the study. Acacia anguistissima was used as a protein source and included in broiler diets at 0, 50 and 100 g/kg. Total feed intake (TFI), average daily gain (ADG), and gain to feed ratio (G:F) and cost benefit analysis were determined. There were no differences in TFI of broilers across treatments diets. Average daily gain and gain to feed (G:F) ratio were low (P < 0.05) for broilers feeding on diet with100 g/kg acacia meal. Highest returns from weight gain were obtained from broiler chickens fed on diet with 50 g/kg inclusion level of A. anguistissima (P < 0.05). Intestinal length increased with inclusion level of A. anguistissima whereas liver and spleen weight decreased with inclusion level of A. anguistissima (P < 0.05). Female consumers gave higher scores for overall flavour intensity than male consumers (P < 0.05). Treatment diets influenced consumer sensory characteristics of broiler meat (P < 0.05). High sensory scores were observed for overall flavour intensity (OFI) for both boiled and deep fried meat from broilers fed 100 g/kg A. anguistissima. It can be concluded that A. anguistissima meal can be used effectively up to 50 g/kg in broiler diets without compromising performance of chickens and can influence a few sensory characteristics.

Testicular lymphangiectasis are described for the first time in a patient with bilateral inguinal cryptorchidism. A great number of irregular lymphatic channels was observed within the parenchyma and the tunica vasculosa in both testes. Large and numerous anastomosis between the lymphatic vessels of these two areas could also be seen. The MTD and the TFI of the left testis were normal. Both parameters were very low in the right testis. The association of this fact with the greater development of the lymphatic vessels in this testis strongly supports the idea that testicular lymphangiectasis interfere mechanically with the testis tubular development.

Proprietà psicometriche della versione italiana del Tinnitus Functional Index (TFI).

Riassunto: Diversi questionari sono utilizzati per valutare l’impatto dell’acufene sulla qualità della vita. Il Tinnitus Functional Index (TFI) proposto da Meikle et al, nel 2012, ha dimostrato proprietà eccellenti per misurare la gravità e le modificazioni indotte dal trattamento degli acufeni, sia in ambito clinico che di ricerca. Lo scopo di questo studio è stato valutare le proprietà psicometriche della versione italiana del TFI, in particolare, l’analisi fattoriale, la consistenza interna, l’affidabilità e la validità. La versione originale inglese del TFI è stata tradotta in italiano secondo la procedura translation - back translation; 137 partecipanti con acufeni da almeno 3 mesi (39,4% femmine, età: 18-80 anni, età media: 48,26, SD: 14,08), reclutati presso la Tinnitus Clinic di Milano, hanno completato la versione italiana del TFI, il Tinnitus Handicap Inventory, la Beck Depression Inventory - Versione Primary Care e la scala di valutazione numerica per il fastidio. Una parte del campione, 57 pazienti, ha completato la versione italiana del TFI in una seconda visita, dopo 7-14 giorni, prima di ricevere qualsiasi tipo di trattamento, per ricavare i dati per la valutazione della riproducibilità. Le proprietà psicometriche sono state studiate attraverso un’analisi fattoriale esplorativa ed il calcolo di misure di consistenza interna e affidabilità test-retest. La validità convergente è stata valutata mediante i coefficienti di correlazione con le restanti misure. La versione italiana del TFI ha mostrato una struttura a quattro fattori, parzialmente diversa dalla struttura originale a otto fattori. L’adattamento italiano del TFI ha rivelato buoni livelli di consistenza interna (0,92 ≤ α ≤ 0,96) e affidabilità test-retest (0,79 ≤ α ≤ 0,85). In termini di validità convergente, ha mostrato buone correlazioni con i punteggi del THI (r = 0,77) e della scala del fastidio (r = 0,70) e correlazioni medie con i punteggi del BDI (r = 0,46). Le difficoltà nel riprodurre la struttura originale a otto fattori sono coerenti con altri studi di validazione del TFI nelle lingue europee. Nonostante tali discrepanze, la versione italiana del TFI ha mostrato una struttura fattoriale caratterizzata da alti livelli di affidabilità e validità. Nel complesso, l’adattamento italiano di TFI si è rivelato idoneo a misurare l’impatto degli acufeni sulla vita quotidiana degli individui.

Keywords: convergent validity; exploratory factor analysis; outcome instruments; reliability; tinnitus.

Tetrastichus howardi (Olliff) (Hymenoptera: Eulophidae), a pupal parasitoid of a great number of Lepidoptera pests, has a great potential for biological control. To investigate the olfactory system of this parasitoid, we examined the morphology and ultrastructure of the antennal sensilla of both male and female T. howardi using scanning and transmission electron microscopic techniques. Antennae of male and female T. howardi were geniculate in shape, which consisted of scape, pedicel and flagellum with 5 and 4 flagellomeres, respectively. The sexual differences were recorded in the types, structure, distribution and abundance of antennal sensilla of T. howardi. Fourteen morphologically distinct types of antennal sensilla were found on the female antennae, while seventeen on the male antennae. They were: multiporous plate sensilla (MPS1-4), chaetica sensilla (CH1-3), multiporous trichodea sensilla (MTS), aporous trichodea sensilla (ATS1-5), multiporous grooved peg sensilla (MGPS), coeloconic sensilla (COS), campaniform sensilla (CAS), terminal finger-like hairy sensilla (TFI), cuticular pore (CP), and ventral sensory plaque (VSP). MPS4, ATS (3-5), and VSP only occurred on the male antennae, while MPS2 and MPS3 only on the female antennae. The MPSs, MTS, MGPS, TFI, and CP may function as olfactory sensilla involving in detecting odor stimuli whereas the ATSs, CHs, and CAS may serve as mechanoreceptors. COS were presumed to play a role as chemo-, thermo- or hygro-receptor. The results could facilitate future studies on the biology of olfaction in T. howardi.

Background and objectives: Fluid monitoring is an important management strategy in patients with chronic kidney disease (CKD) and heart failure (HF). The µCor™ Heart Failure and Arrhythmia Management System uses a radiofrequency-based thoracic fluid index (TFI) to track pulmonary edema. During hemodialysis, the acute removal of fluid through ultrafiltration offers a model for measuring a patient's fluid status. The objective of the study was to assess the relationship between the device measured TFI and ultrafiltration volume (UFV).

Design setting participants and measurements: Patients undergoing chronic dialysis with and without heart failure were enrolled in the study. The relationship between TFI and UFV in each individual subject was assessed by calculating the Pearson correlation coefficient (r). The average correlation across all subjects was calculated through the use of the Fisher's z transform. Responder analysis was performed to assess the magnitude of change in TFI before and after dialysis.

Results: Twenty subjects were enrolled in the trial. The mean volume of fluid removal was 3.63 L (SD 0.88 L). The mean correlation based on Fisher's transform was 0.95 CI (0.92-0.99). Responder analysis showed that the mean reduction of TFI after dialysis was 5.5% ± 3.8.

Conclusion: The µCor system provides radiofrequency-based measurements of thoracic fluid which correlate well with total body fluid removal in a real-world setting. Fluid management based on the radar-derived TFI may provide benefits to dialysis patients and serves as a potential model for pulmonary edema common to the clinical course of heart failure.

Keywords: dialysis; heart failure; total body fluid monitoring; ultrafiltration; wearables.

Background: Nearly 14% of US women report any lifetime infertility which is associated with healthcare costs and psychosocial consequences. Tubal factor infertility (TFI) often occurs as a result of sexually transmitted diseases and subsequent pelvic inflammatory disease. We sought to evaluate for and describe potential racial disparities in TFI and in vitro fertilization (IVF) prevalence.

Methods: Records of women aged 19-42 years in our retrospective cohort from two US infertility clinics were reviewed. We calculated TFI prevalence, IVF initiation prevalence, and prevalence ratios (PR), with 95% confidence intervals for each estimate, overall and by race.

Results: Among 660 infertile women, 110 (16.7%; 95% confidence interval [CI] 13.8-19.5%) had TFI which was higher in black compared to white women (30.3% [33/109] vs. 13.9% [68/489]; PR 2.2 [95% CI 1.5-3.1]). For women with TFI, IVF was offered to similar proportions of women by race (51.5% [17/33] versus 52.9% [36/68] for black versus white women); however, fewer black than white women with TFI started IVF (6.7% [1/15] versus 31.0% [9/29]; PR 0.2 [95% CI 0-1.0]), although the difference was not statistically different.

Conclusions: TFI prevalence was two-fold higher among black than white women seeking care for infertility. Among women with TFI, data suggested a lower likelihood of black women starting IVF than white women. Improved sexually transmitted disease prevention and treatment might ameliorate disparities in TFI.

Introduction: There have been no comprehensive studies that assess the impact of frailty syndrome on quality of life (QoL) of patients with diagnosed type 2 diabetes. The purpose of the study was to assess the impact of frailty syndrome on QoL and depression symptoms of patients with type 2 diabetes.

Methods: The study included 148 consecutive patients (aged ≥ 60y). The patients were divided into two groups according to the prevalence of the frailty syndrome: robust and frailty. For all of the patients that were included in the study, we used the Polish version of validated instruments: ADDQoL, TFI and BDI.

Results: In the study group, 43.2% had been diagnosed with frailty syndrome. An analysis of QoL assessment depending on the prevalence of the frailty syndrome showed that patients who were robust (without recognized frailty syndrome) assessed QoL significantly better than patients with coexisting frailty syndrome. Robust patients did not have any severe depressive symptoms, whereas in the group of patients with the frailty syndrome 43.8% of the patients had a depression. 70.2% of the patients without any depressive symptoms were robust patients, meanwhile only 14% of the patients had frailty syndrome recognized.

Conclusions: Frailty syndrome occurred in 43 percent of the patients with type 2 diabetes. This has a negative impact on QoL of patients. Depression is more common in patients with the frailty syndrome and diabetes.

Keywords: Frailty syndrome; Quality of life; Type 2 diabetes.

Background: In HER2-positive breast cancer, time elapsed between completion of (neo)adjuvant trastuzumab and diagnosis of metastatic disease ('trastuzumab-free interval', TFI) is crucial to choose the optimal first-line treatment. Nevertheless, there is no clear evidence to support its possible prognostic role.

Methods: In the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimisation (ALTTO) trial, patients with HER2-positive early breast cancer were randomised to 1 year of either trastuzumab alone, lapatinib alone, their sequence or their combination. This exploratory analysis included only patients in the trastuzumab alone or trastuzumab plus lapatinib arms who developed a distant disease-free survival (DDFS) event. Overall survival (OS) was defined as time between date of DDFS event and death; age at diagnosis, tumour size and hormone receptor status were the variables included in the multivariate models.

<strong class="sub-title"> Results: </strong> Out of 8381 patients included in ALTTO, 404 patients in the trastuzumab alone and trastuzumab plus lapatinib arms developed a DDFS event, of which 201 occurred <underline><</underline>12 months (group A) and 203 >12 months (group B) after completion of adjuvant trastuzumab. No significant difference in location of first DDFS event was observed (p=0.073); a numerically higher number of patients in group A than in group B developed brain metastasis (26% vs 15%). Choice of first-line therapy differed between the two groups (p=0.022): in group A, more patients received lapatinib (25% vs 11%) and less pertuzumab (8% vs 17%). Median OS was 29.3 and 18.4 months in groups B and A, respectively (adjusted HR 0.69; 95% CI 0.54-0.89; p=0.004). The longer OS for patients in group B was observed across the analysed subgroups without interaction according to hormone receptor status (p=0.814) nor type of administered adjuvant anti-HER2 treatment (p=0.233).

Conclusions: TFI has prognostic value in patients with HER2-positive early breast cancer treated with adjuvant trastuzumab-based therapy. TFI is a valid tool to better individualise clinical recommendations and to design future first-line treatment trials for metastatic patients.

Keywords: HER2-positive; adjuvant therapy; breast cancer; prognosis; trastuzumab.

The aim of study was to assess prevalence, severity, and associated risk-factors for Dental Fluorosis in Pre-School children (1-6 years) in Fluoride deficient regions (1) Tbilisi (F=0.08-0.22 mg/l) and (2) Akhaltsikhe, (F<0.4 mg/l) Georgia, having different geographic location and socio-economic conditions. A cross-sectional study was carried out on 570 pre-school aged children (1-6 years) attending public kindergartens of Tbilisi and Akhaltsikhe region. Descriptive analysis was performed for Dental Fluorosis prevalence and severity using Thylstrup-Fejerskov Index (TFI). Correlative analysis was done to assess information about possible acquired risk-factors through questionnaire including biological and social variables. To differentiate genuine Dental fluorosis from other non-carious resembling defects ECEL method was introduced. For Fluoride concentration determination in potable water (2) ISO 10359-1:1992 Electrochemical probe as ion-selective electrode method was used. Information about F concentration in Tbilisi tap water (1) was obtained by GWP. (Georgian Water and Power, 2019). The overall Prevalence of Dental Fluorosis in study group was 6.3% (36 Children) (95% CI;(4.3 - 8.3)). There was no statistically significant difference in the level of Dental Fluorosis prevalence between rural and urban residents (P>0.05). Dental Fluorosis prevalence was similar in both gender groups. 6.0% of girls had dental fluorosis (95% CI 2.2% - 8.8%), whereas DF prevalence in boys was 6.5% (95% CI3.7% - 9.3%), respectively. Regular brushing and dentifrices ingestion were not effecting DF prevalence and severity (p>0.05). Indoor coal-burning environment increasing airborne Fluoride absorption during pregnancy was recognized as a risk-factor for dental fluorosis occurrence in children (OR=5.8 (95% CI; 2.1-15.9)). High tea consumption (≥2 cups/day) was increasing Odds of DF occurrence (OR=17.3 (95% CI; 7.4-40.7)). Exposure to diverse fluoride sources like indoor coal-burning and high tea consumption in non-fluoridated areas is a risk-factor of Dental Fluorosis in study community.

Pinellia tuber (PTE, , , , , , , , ) is derived from the tuber of Pinellia ternata Breitenbach (Araceae), which is a crude drug used in traditional Japanese Kampo medicine for the purpose of antiemesis and expectoration. Since the separation of ephedrine from PTE in 1978, it has been listed as a PTE component in textbooks and internet information. Therefore, there are harmful effects on appropriate use in clinical practice because PTE is dealt with as a crude drug for doping target, and traditional Japanese Kampo medicine containing PTE must be carefully administered to the elderly. However, since the 1978 published report, there has not been any report on the isolation of ephedrine from PTE and the interpretation of biosynthesis remains questionable. In the present study, we analyzed the PTE samples in market distribution products by LC-TOF/MS. From the analysis of the result of ephedrine's m/z 148.113 [M + H-H₂O]⁺, PTE was not detected (n = 55, detection limit: 0.5 ppb). Additionally, the tuber of P. tripartite (PTR, ), the tuber of P. pedatisecta (PPE, ), Arisaema Tuber (ART, ), and the tuber of Typhonium flagelliforme (TFI, ) that have a similar description to PTE were also not detected. Moreover, the genetic analysis of experimental samples showed that PTE is derived from P. ternata. Furthermore, our attempt to isolate ephedrine from PTE based on the past literature was unsuccessful. These results suggest that PTE in market distribution products may not contain ephedrine as a component.

Keywords: Anti-doping; Ephedrine; LC-TOF/MS; Pinellia ternata; Pinellia tuber.

Prognostic factors of patients with metastatic lung tumors were evaluated on 72 patients who were treated with pulmonary resection (49 via lateral thoracotomy and 23 via median sternotomy). The 5-year survival rate of these patients was 41.3%. Two factors, i.e., tumor free interval (TFI) and tumor size, significantly affected the survival after surgery. Patients with a longer TFI and smaller tumor(s) were associated with a favorable prognosis. The prognosis, however, was neither affected by the number of metastatic lung tumors nor whether they were unilateral or bilateral. The prognosis of lung metastases from colorectal cancer was the most favorable (61.4% at 5-year). On the other hand, patients with lung metastases from renal cell carcinoma and breast carcinoma showed poor prognosis respectively. As for testicular tumors and bone or soft tissue sarcomas, chemo-sensitivity is the most important prognostic factor. Good responders to prior chemotherapy showed a better prognosis than poor responders. These results urge the reappraisal of the role of surgery in the treatment of metastatic lung tumors and demonstrate that aggressive surgery can be indicated even for multiple or bilateral lung metastases. Nature of metastatic tumors, i.e., their origin and chemo-sensitivity, must be taken into consideration when the indication for surgery is decided.

OBJECTIVE

To assess drinking occasions (volume and type) according to consumption with food in or outside meals, and location, for six countries.

METHODS

A total of 10,521 participants aged 4-65 years from Argentina, Brazil, China, Indonesia, Mexico and Uruguay completed a validated 7-day fluid intake record. For each drinking event, the volume consumed, the fluid type, the location of intake, and whether the drink was accompanied by food (meal or snack) or not, was recorded.

RESULTS

Similar drinking behaviors were found in Mexico and Argentina; fluid intake during meals was 48 and 45% of total fluid intake (TFI), respectively. In Brazil (55%), Indonesia (58%) and China (66%) most fluid was consumed without food. In Uruguay, 34% of TFI was with a main meal, 31% with food between meals and 35% without food. Indonesia had the highest median (25-75th percentile) TFI; 2520 (1750-3347) mL/day, and China the lowest 1138 (818-3347) mL/day. Water was consumed with meals for 37% of Chinese and 87% of Indonesian participants, while the four Latin-American American countries showed a preference for sweet drinks; 54% in Mexico, 67% in Brazil, 55% in Argentina and 59% in Uruguay. Diversity in fluid type was noted when drinking with food between meals. Apart from China, most drinking occasions >> 75%) occurred at home.

CONCLUSIONS

Three distinct drinking behaviors were identified, namely, drinking with meals, drinking as a stand-alone activity, and a type of 'grazing' (i.e., frequent drinks throughout the day) behavior. Most drinking occasions occurred at home.

OBJECTIVE

The primary aim of this survey was to report total fluid intake (TFI) and different fluid types for children (4-9 years) and adolescents (10-17 years) in Mexico, Brazil, Argentina and Uruguay. The second aim was to compare TFI with the adequate intake (AI) of water from fluids as recommended by the USA Institute of Medicine.

METHODS

Data were collected using a validated liquid intake 7-day record (Liq.In 7 ). Participants' characteristics, including age, sex and anthropometric measurements were recorded.

RESULTS

A total of 733 children and 933 adolescents were recruited. Over 75% of children in Uruguay met the IOM's recommended intake. Fewer children in Argentina (64-72%) and Brazil (41-50%) obtained AI and the lowest values were recorded in Mexico (33-44%), where 16% of boys and 14% girls drank 50% or less of the AI. More adolescents in Argentina (42%) met the AIs than other countries; the lowest was in Mexico (28%). Children and adolescents in Mexico and Argentina drank more sugar sweetened beverages than water.

CONCLUSIONS

Large numbers of children and adolescents did not meet AI recommendations for TFI, raising concerns about their hydration status and potential effects on mental and physical well-being. Given the negative effects on children's health, the levels of SSB consumption are worrying.

The authors have studied the sequential changes in hemodynamic responses and Atrial Natriuretic Peptide (ANP) levels following bicarbonate hemodialysis with fluid removal followed by an infusion of saline and then ultrafiltration of the added fluid. Cardiac output, stroke volume, and thoracic fluid index (TFI) were measured by transthoracic impedence cardiography. Left cardiac work index (LCWI) was derived using these hemodynamic and mean arterial pressure (MAP) measurements. MAP was lower following dialysis when compared to pure ultrafiltration of a similar fluid loss. LCWI decreased during both dialysis and ultrafiltration. TFI, which is inversely related to intrathoracic fluid, increased following dialysis and ultrafiltration. ANP levels fell following fluid removal but remained elevated above normal control levels. The authors conclude that ANP levels are related to fluid not cardiac status in dialysis patients and that impedence cardiography is of value in determining hemodynamic and fluid changes during dialysis.

OBJECTIVE

The purpose of this study is to evaluate the in-hospital clinical outcome of patients with coronary artery disease who underwent transradial intervention (TRI) and analyze the predictors of clinical outcome.

METHODS

From May 2004 to May 2009, there were 16 281 patients who underwent transradial intervention, as well as 5388 patients who underwent transfemoral intervention (TFI) at our institution. The clinical characteristics, procedural characteristics, and in-hospital clinical adverse events were compared between TRI and TFI groups. Multivariable logistic regression analysis was performed to determine predictors of in-hospital major adverse cardiac events (composite of death, myocardial infarction, or target lesion revascularization) of TRI.

RESULTS

The annulations time was significantly longer for TRI than TFI (P < 0.01), fluoroscopy time, amount of contrast agent and procedural success rate (95.5% for TRI and 96.2% for TFI) were similar between the two groups. However, the rates of vascular complications (0.1% for TRI group and 1.3% for TFI group, P < 0.01), incidence of in-hospital major adverse cardiac events (1.6% vs. 3.8%, P < 0.01) and in-hospital death (0.2% vs. 0.4%, P < 0.01) were all significantly lower in TRI group compared with TFI group. The following characteristics were identified as independent multivariate predictors of in-hospital major adverse cardiac events of TRI: age ≥ 65 (OR: 1.98, 95%CI: 1.50 - 2.61, P < 0.01), prior myocardial infarction (OR: 2.14, 95%CI: 1.63 - 2.82, P < 0.01), use of drug-eluting stent (DES) (OR: 0.68, 95%CI: 0.47 - 0.98, P = 0.04), dissection during procedure (OR: 4.08, 95%CI: 2.28 - 7.33, P < 0.01), left main lesion (OR: 2.12, 95%CI: 1.09 - 4.13, P = 0.03), number of implanted stents (OR: 1.25, 95%CI: 1.09 - 1.43, P < 0.01), and total stented length (OR: 1.01, 95%CI: 1.00 - 1.02, P = 0.03).

CONCLUSIONS

In this large single-centre patient cohort, the transradial intervention is superior to transfemoral intervention in terms of in-hospital safety and efficacy. Age ≥ 65, prior myocardial infarction, use of DES, dissection during procedure, left main lesion, number of implanted stents and total stented length were identified as independent multivariate predictors of in-hospital major adverse cardiac events of TRI.

Optical coherence tomography (OCT) angiography (OCTA) is a non-invasive tool for the in-vivo study of the intraretinal vascular network. It is based on the analysis of motion particles within the retina to reconstruct the paths followed by the erythrocytes, i.e. retinal capillaries. To date, qualitative and quantitative information are based on the morphological features disclosed by retinal capillaries. In the present study, we proposed new quantitative functional metrics, named Total Flow Intensity (TFI), Active Flow Intensity (AFI), and Volume-related Flow Intensity (VFI), based on the processing of the blood flow signal detected by OCTA. We studied these metrics in a cohort of healthy subjects, and we assessed their clinical utility by including a cohort of age-matched patients affected by Stargardt disease. Moreover, we compared TFI, AFI, and VFI to the widely used vessel density (VD) parameter. TFI, AFI, and VFI were able to describe in detail the different properties of the retinal vascular compartment. In particular, TFI was intended as the overall amount of volumetric retinal blood flow. AFI represented a selective measure of voxels disclosing blood flow signal. VFI was developed to put in relationship the volumetric blood flow information with the not vascularized retinal volume. In conclusion, TFI, AFI, and VFI were proposed as feasible functional OCTA biomarkers based on the analysis of retinal blood flow signal.

Background: Chlamydial infection is associated with tubal factor infertility (TFI); however, assessment of prior chlamydial infection and TFI is imperfect. We previously evaluated a combination of serological assays for association with TFI. We now describe the chlamydial contribution to TFI using a newer Chlamydia trachomatis Pgp3 enhanced serological (Pgp3) assay.

Methods: In our case-control study of women 19-42 years old with hysterosalpingogram-diagnosed TFI (cases) and non-TFI (controls) in two U.S. infertility clinics, we assessed possible associations and effect modifiers between Pgp3 seropositivity and TFI using adjusted odds ratios (aOR) with 95% confidence intervals (CI) stratified by race. We then estimated the adjusted chlamydia population attributable fraction (aPAF) with 95% CI of TFI.

Results: All black (n=107) and 618 of 620 non-black women had Pgp3 results. Pgp3 seropositivity was 25.9% (19.3-33.8%) for non-black cases, 15.2% (12.3-18.7%) for non-black controls, 66.0% (95% CI 51.7-77.8%) for black cases, and 71.7% (59.2-81.5%) for black controls. Among 476 non-black women without endometriosis (n=476), Pgp3 was associated with TFI (aOR 2.6 [1.5-4.4]), adjusting for clinic, age, and income; chlamydia TFI aPAF was 19.8% (95% CI 7.7-32.2%) in these women. Pgp3 positivity was not associated with TFI among non-black women with endometriosis nor among black women (regardless of endometriosis).

Conclusions: Among non-black infertile women without endometriosis in these clinics, 20% of TFI was attributed to chlamydia. Better biomarkers are needed to estimate chlamydia TFI PAF, especially in black women.

Objectives: Frailty marks an increased risk for adverse health outcomes. Since childhood trauma is associated with the onset of physical and mental health diseases during the lifespan, we examined the link between childhood trauma and multidimensional frailty.

Method: A cross-sectional study embedded in a clinical cohort study (ROM-GPS) of older (≥60 years) patients (n=182) with a unipolar depressive-, anxiety- and/or somatic symptom disorder according to DSM-criteria referred to specialized geriatric mental health care. Frailty was assessed with the Tilburg Frailty Indicator (TFI), comprising a physical, psychological, and social dimension. Physical, sexual and psychological abuse and emotional neglect before the age of 16 years was measured with a structured interview.

Results: Of 182 patients, 103 (56.6%) had experienced any childhood trauma and 154 (84.6%) were frail (TFI sum score ≥5). Linear regression analyses, adjusted for lifestyle, psychological and physical-health factors, showed that the presence of any type of childhood trauma was not associated with the TFI sum score, however when considered separately, physical abuse was (ß=0.16, p=.037). Regarding the specific frailty dimensions, any childhood trauma was associated with social frailty (ß=0.18, p=.019), with emotional neglect as main contributor.

Conclusion: These findings demonstrate a complex link between different types of childhood trauma and multidimensional frailty among older psychiatric patients. Regarding the three dimensions of frailty, social frailty seems most affected by childhood trauma. This may have been underestimated until now and should receive more attention in clinical care and future research.

Keywords: Adverse childhood experiences; Affective disorders; Aged; Child abuse; Frail elderly; Frailty; Mental health; Mood disorders.

Introduction: Tinnitus is the perception of sound without an external stimulus, often experienced as a ringing or buzzing sound. Subjective tinnitus is assumed to origin from changes in neural activity caused by reduced or lack of auditory input, for instance due to hearing loss. Since auditory deprivation is thought to be one of the causes of tinnitus, increasing the auditory input by cochlear implantation might be a possible treatment. In studies assessing cochlear implantation for patients with hearing loss, tinnitus relief was seen as a secondary outcome. Therefore, we will assess the effect of cochlear implantation in patients with primarily tinnitus complaints.

Method and analysis: In this randomised controlled trial starting in January 2021 at the ENT department of the UMC Utrecht (the Netherlands), patients with a primary complaint of tinnitus will be included. Fifty patients (Tinnitus Functional Index (TFI)>TFI. Outcomes of interest are tinnitus severity, hearing performances (tinnitus pitch and loudness, speech perception), quality of life, depression and patient-related changes. Outcomes will be evaluated prior to implantation and at 3 and 6 months after the surgery. The control group will receive questionnaires at 3 and 6 months after randomisation. We expect a significant difference between the cochlear implant recipients and the control group for tinnitus burden.

Ethics and dissemination: This research protocol was approved by the Institutional Review Board of the University Medical Center (UMC) Utrecht (NL70319.041.19, V5.0, January 2021). The trial results will be made accessible to the public in a peer-review journal.

Trial registration number: Trial registration number NL8693; Pre-results.

Keywords: adult otolaryngology; audiology; otolaryngology.

Objectives: Chronic tinnitus negatively impacts daily functioning. To specifically assess this impairment, the Tinnitus Functional Index (TFI) was developed. The current study investigated the hierarchical, eight-factorial structure for the German TFI and examined its psychometric properties.

Design: In an online assessment, the TFI and other validated health-related measurements were completed. Confirmatory factor analysis (CFA) was conducted to investigate the factorial structure by testing two competing models: (1) a general factor model, and (2) a hierarchical second-order factor model.

Study sample: 316 research volunteers (59.8% female) with low to moderate tinnitus distress were included.

Results: CFA revealed an insufficient fit of the data to the general factor model. For the hierarchical second-order factor model, an acceptable model fit was shown (χ²/df ratio = 2.74, RMSEA = 0.07, SRMR = 0.05, CFI = 0.95, TLI = 0.95). Correlational analyses between the TFI and measures assessing tinnitus distress, depression, sleeping difficulties, subjective well-being, and personality dimensions indicated high convergent and moderate discriminant validity. Internal consistency reliability was excellent.

Conclusions: The results confirm the hierarchical, eight-factorial structure of the German TFI. The TFI is a promising inventory that should be used on a regular basis.HighlightsThe results of our study confirm the hierarchical eight-factorial structure of the German TFI.Confirmatory factor analysis revealed an acceptable model fit of the data.Convergent validity of the German TFI was high.Discriminant validity of the German TFI was moderate.The German TFI is a reliable questionnaire to assess tinnitus functional impairment.

Keywords: Tinnitus functional impairment; confirmatory factor analysis; convergent validity; discriminant validity; reliability; tinnitus questionnaire.

Background: Laterally extended endopelvic resection (LEER) has been introduced for treatment of pelvic sidewall recurrence of cervical cancer (PSRCC), which occurs in only 8% of patients with relapsed cervical cancer. LEER can only be performed by a proficient surgeon due to the high risk of surgical morbidity and mortality, but there is no evidence as to whether LEER is may be more effective than chemo or targeted therapy alone for PSRCC. Thus, we aimed to compare the efficacy and safety between LEER and chemo or targeted therapy alone for treatment of PSRCC.

Methods: We prospectively recruited patients with PSRCC who underwent LEER between December 2016 and December 2019. Moreover, we retrospectively collected data on patients with PSRCC who received chemo or targeted therapy alone between January 2000 and December 2019. We compared treatment-free interval (TFI), progression-free survival (PFS), treatment-free survival (TFS), overall survival (OS), tumor response, neurologic disturbance of the low extremities, and pelvic pain severity in the different patient groups.

Results: Among 1295 patients with cervical cancer, we included 28 (2.2%) and 31 (2.4%) in the prospective and retrospective cohorts, respectively. When we subdivided all patients into two groups based on the median value of prior TFI (PTFI, 9.2 months), LEER improved TFI, PFS, TRS and OS compared to chemo or targeted therapy alone (median, 2.8 vs. 0.9; 7.4 vs. 4.1; 30.1 vs. 16.9 months; P ≤ 0.05) in patients with PTFI < 9.2 months despite no difference in survival in those with PTFI ≥ 9.2 months, suggesting that LEER may lead to better TFI, PFS, TRS and OS in patients with PTFI < 9.2 months (adjusted hazard ratios, 0.28, 0.27, 0.44 and 0.37; 95% confidence intervals, 0.12-0.68, 0.11-0.66, 0.18-0.83 and 0.15-0.88). Furthermore, LEER markedly reduced the number of morphine milligram equivalents necessary to reduce pelvic pain when compared with chemo or targeted therapy alone.

Conclusion: Compared to chemo or targeted therapy alone, LEER improved survival in patients with PSRCC and PTFI < 9.2 months, and it was effective at controlling the pelvic pain associated with PSRCC.

Trial registration: ClinicalTrials.gov, identifier NCT02986568.

Keywords: cervical cancer; laterally extended endopelvic resection; pain; pelvic sidewall recurrence; survival.