The effectiveness of erector spina plane, quadratus lumborum blocks, and intrathecal morphine for analgesia after cesarean: a randomized study

SUMMARY OBJECTIVE: This prospective randomized study was conducted at Ataturk University Medical Faculty Hospital, Department of Anesthesia and Reanimation, from June 2022 to May 2023. The aim of this study was to compare the effectiveness of ultrasound-guided erector spinae plane block, quadratus lumborum block, and intrathecal morphine to decrease postoperative pain after cesarean section. METHODS: Sixty-term pregnant women who were scheduled for elective cesarean sections with spinal anesthesia were included. Patients were randomly divided into three groups (n=20 for each group): Group 1: Patients were administered intrathecal morphine during spinal anesthesia; Group 2: Patients performed bilateral erector spinae plane block postoperatively; and Group 3: Patients performed bilateral quadratus lumborum block postoperatively. In the postpartum care unit, patients received intravenous Patient-Controlled Analgesia. The Patient-Controlled Analgesia devices were set to administer an intravenous bolus of 25 μg fentanyl, with a lockout interval of 10 min. Opioid consumption and maximum pain score in the 24 postoperative hours were recorded. RESULTS: Patients in Group 1 had a longer time to first analgesic requirement compared to Group 2 (p=0.017). Opioid consumption and resting and moving visual analog score scores in the first 24 h postoperatively were similar between groups. CONCLUSION: All three methods, including intrathecal morphine, erector spinae plane block, and quadratus lumborum block, are efficacious and comparable in providing postoperative analgesia after cesarean under spinal anesthesia.

The effects of favipiravir on hematological parameters of covid-19 patients

SUMMARY INTRODUCTION This study aims to evaluate changes in hematological parameters after the follow-up of patients who received treatment with favipiravir due to COVID-19 infections. METHODS Sixty-two cases receiving favipiravir treatment for at least five days due to COVID-19 infection were evaluated retrospectively. Parameters including age, gender, nasopharyngeal swab positivity, and chronic diseases were analyzed. Hematologic parameters were analyzed before and after the treatment. RESULTS The mean age of the patients receiving treatment with favipiravir was 63.7±12.3 years. Nasopharyngeal swab positivity was detected in 67.7%. The most common comorbid conditions detected in patients were hypertension in 25 cases (40.3%) and diabetes in 16 cases (25.8%). In the statistical analysis of the hematological parameters before and after treatment with favipiravir, WBC, PT-PTT-INR levels were found to be unaffected; the mean RBC was found to have decreased from 4.33 ± 0.58 M/uL to 4.16 ± 0.54 M/uL (p:0.003); the median hemoglobin level was found to have decreased from 12.3 g/dl to 11.9 g/dl (p:0.041); the hematocrit level decreased from 38.1% ± 4.8 to 36.9% ± 4.2 (p:0.026); the median neutrophil count decreased from 4.57 K/uL to 3.85 K/uL (p:0.001); the mean lymphocyte count increased from 1.22 ± 0.53 K/uL to 1.84 ± 1.19 K/uL (p:0.000); and the mean platelet count increased from 244.1 ± 85.1 K/uL to 281.9 ± 103.3 K/uL (p:0.005). CONCLUSION We concluded that the pathological effect of treatment with favipiravir on the hematologic system was the suppression in the erythrocyte series, and there were no adverse effects in other hematologic parameters.

RESUMO INTRODUÇÃO Este estudo tem como objetivo avaliar as alterações nos parâmetros hematológicos após o acompanhamento de pacientes que receberam tratamento com favipiravir devido à infecção por Covid-19. MÉTODOS Sessenta e dois casos em tratamento com favipiravir por pelo menos cinco dias devido à infecção por Covid-19 foram avaliados retrospectivamente. Parâmetros como idade, sexo, positividade do swab nasofaríngeo e doenças crônicas foram analisados. Os parâmetros hematológicos foram analisados antes e após o tratamento. RESULTADOS A idade média dos pacientes que receberam tratamento com favipiravir foi de 63,7±12,3 anos. A positividade do swab nasofaríngeo foi detectada em 67,7%. As condições comórbidas mais comuns detectadas nos pacientes foram hipertensão em 25 casos (40,3%) e diabetes em 16 casos (25,8%). Na análise estatística dos parâmetros hematológicos antes e após o tratamento com favipiravir, os níveis de leucócitos, PT-PTT-INR não foram afetados. Verificou-se que o RBC médio diminuiu de 4,33±0,58 M/uL para 4,16±0,54 M/uL (p=0,003); o nível médio de hemoglobina foi reduzido de 12,3 g/dl para 11,9 g/dl (p=0,041); o nível de hematócrito diminuiu de 38,1%±4,8 para 36,9%±4,2 (p=0,026); a contagem mediana de neutrófilos diminuiu de 4,57 K/uL para 3,85 K/uL (p=0,001); a contagem média de linfócitos aumentou de 1,22±0,53 K/uL para 1,84±1,19 K/uL (p=0,000); a contagem média de plaquetas aumentou de 244,1±85,1 K/uL para 281,9±103,3 K/uL (p=0,005). CONCLUSÃO Concluiu-se que o efeito patológico do tratamento com favipiravir no sistema hematológico foi a supressão na série eritrocitária e que não houve efeitos adversos em outros parâmetros hematológicos.

Neutrophil count to albumin ratio as a new predictor of mortality in patients with COVID-19 infection

SUMMARY BACKGROUND Coronavirus Disease 2019 is an acute inflammatory respiratory disease. It causes many changes in hemogram parameters. Low albumin levels are associated with mortality risk in hospitalized patients. The aim of the present study is to reveal the place of neutrophil count to albumin ratio in predicting mortality in patients with COVID-19. METHODS 144 patients, 65 females and 79 males, were included in the study. Patients were divided into 2 groups. Group 1 was the non-severe group (n:85), and Group 2 was severe (n:59). Demographic data, neutrophil, lymphocyte and platelet counts, albumin and C-reactive protein (CRP) levels were recorded. Neutrophil count to albumin ratio (NAR) was calculated by dividing the absolute neutrophil counts by the albumin levels. The NAR and levels of the two groups were then compared. RESULTS There were no significant differences in gender and platelet count (201 vs. 211 K/mL) between the groups (p>0,05). Ages (62.0 ± 14.3 vs 68.6 ± 12.2 years), albumin (33.1 vs 29.9 gr/L), CRP (33 vs 113 mg/l), neutrophil count (4 vs 7.24 K/mL), WBC counts (6.70 vs 8.50 K/mL), NAR values (113.5 vs 267.2) and number of Death (5 vs 33) were found to be statistically higher (p <0.001) in Group 2 than in Group 1. The NAR value of 201.5 showed mortality in all patients with COVID-19 to have 71.1% sensitivity and 71.7% specificity (AUC:0.736, 95% CI: 0.641-0.832, p<0.001) CONCLUSION The present study showed that NAR levels can be a cheap and simple marker for predicting mortality in patients with COVID-19.

RESUMO ANTECEDENTES A doença de coronavírus 2019 é uma doença respiratória inflamatória aguda. Causa muitas alterações nos parâmetros do hemograma. Baixos níveis de albumina estão associados ao risco de mortalidade em pacientes hospitalizados. O objetivo do presente estudo é revelar o local da razão entre contagem de neutrófilos e albumina na predição de mortalidade em pacientes com COVID-19. MÉTODOS Cento e quarenta e quatro pacientes do sexo feminino e 79 do sexo masculino foram incluídos no estudo. Os pacientes foram divididos em dois grupos: Grupo 1 não grave (n: 85), Grupo 2 grave (n: 59). Dados demográficos, contagem de neutrófilos, linfócitos e plaquetas, níveis de albumina e proteína C reativa (PCR) foram registrados. A razão de contagem de neutrófilos para albumina (NAR) foi calculada dividindo-se as contagens absolutas de neutrófilos pelos níveis de albumina. O NAR e os níveis dos dois grupos foram comparados. RESULTADOS Não houve diferenças significativas no sexo e na contagem de plaquetas (201 vs 211 K/mL) entre os grupos (p>0,05). Idade (62,0±14,3 vs 68,6±12,2 anos), albumina (33,1 vs 29,9 gr/L), PCR (33 vs 113 mg/l), contagem de neutrófilos (4 vs 7,24 K/mL), contagem de leucócitos (6,70 vs 8,50 K/mL), valores de NAR (113,5 vs 267,2) e número de óbitos (5 vs 33) foram estatisticamente maiores (p<0,001) no Grupo 2 que no Grupo 1. O valor NAR de 201,5 mostrou mortalidade em todos os pacientes com COVID-19 com sensibilidade de 71,1% e especificidade de 71,7% (AUC: 0,736, IC 95%: 0,641-0,832, p<0,001). CONCLUSÃO O presente estudo mostrou que os níveis de NAR podem ser um marcador barato e simples para predizer mortalidade em pacientes com COVID-19.

The effect of abo and rh blood group antigens on admission to intensive care unit and mortality in patients with COVID-19 infection

SUMMARY AIM The aim of this study is to analyze the prognostic significance of ABO and Rh blood group antigens along with various parameters in patients followed-up with the diagnosis of COVID-19. METHODS We evaluated 397 patients who were follow-up and treated due to COVID-19 infections. The ages, genders, chronic diseases, ABO and Rh blood group antigens, admission rates to Intensive Care Units (ICU), and mortality rates of the patients were analyzed. FINDINGS The mean age of the 397 patients with COVID-19 was 47±17 years. In the blood group analysis of the patients, A Rh-positive (A +) was the most frequently seen blood type (176 patients, 44.3%) followed by O Rh-positive (0 +) (109 patients, 27,5%); 38 patients were Rh negative (Rh -) (9,6%). 53 of the patients (13,4%) were followed in ICU and 29 patients died (7,3%). Neither mortality nor admission to ICU was seen for Rh - group. The comparison of Rh groups concerning the need for ICU admission revealed a significantly high rate of ICU admission in the Rh + group (p=0,011), while no significant relationship was found between mortality and Rh antigen (p=0,069). CONCLUSION The most frequently seen blood type among COVID-19 patients was A +. The Rh + blood group was found in all cases who were admitted to ICU and had a death outcome. The Rh + blood group was found in a significantly high number of patients who were admitted to ICU, while no significant relationship was found between mortality and Rh blood group.

RESUMO OBJETIVO O objetivo deste estudo é analisar o significado prognóstico dos antígenos do grupo sanguíneo ABO e Rh, juntamente com vários parâmetros em pacientes acompanhados com o diagnóstico de COVID-19. MÉTODOS Foram avaliados 397 pacientes que foram acompanhados e tratados devido à infecção por COVID-19. Foram analisadas as idades, gêneros, doenças crônicas, antígenos do grupo sanguíneo ABO e Rh, taxas de internação em unidades de terapia intensiva (UTI) e taxas de mortalidade dos pacientes. A idade média de 397 pacientes com COVID foi de 47 ± 17 anos. Na análise do grupo sanguíneo dos pacientes, A Rh positivo (A +) foi o tipo sanguíneo mais frequentemente observado (176 dos pacientes, 44,3%), seguido pelo O Rh positivo (0 +) (109 dos pacientes, 27,5%) 38 dos pacientes eram Rh negativos (Rh -) (9,6%). 53 dos pacientes (13,4%) foram acompanhados em UTI e 29 faleceram (7,3%). Não houve mortalidade nem admissão na UTI para o grupo Rh. A comparação dos grupos Rh quanto à necessidade de admissão na UTI revelou uma taxa significativamente alta de admissão na UTI no grupo Rh + (p = 0,011), enquanto não foi encontrada relação significativa entre mortalidade e antígeno Rh (p = 0,069). CONCLUSÃO O tipo sanguíneo mais frequentemente observado foi o A + entre os pacientes com COVID-19. O grupo sanguíneo Rh + foi encontrado em todos os casos admitidos na UTI e com evolução mortal. O grupo sanguíneo Rh + foi encontrado em um número significativamente alto de pacientes internados na UTI, enquanto nenhuma relação significativa foi encontrada entre a mortalidade e o grupo sanguíneo Rh.

Use of vacuum-assisted closure in massive puerperal genital hematoma

Puerperal genital hematomas are rare but life-threatening complications of obstetric emergencies. A pregnant patient (39 weeks) underwent a mediolateral episiotomy during a vaginal delivery. An afterbirth hematoma (approximately 20 cm in diameter) was evacuated, but the use of a vacuum-assisted wound closure system was applied after the sutures opened on the 7th postoperative day. On the 10th day of the vacuum-assisted closure (VAC) application, the wound was completely closed. VAC is an alternative treatment modality that can drain an infection and increase the proportion of granulation tissue in humid and irregular surfaces such as the perineum.

Successful conservative treatment of type 3 injury [ductal injury] developing after ERCP

Although endoscopic retrograde cholangio-pancreatography [ERCP] is considered a safe procedure, it is associated with complications such as pancreatitis, bleeding and perforation of the bile duct, pancreatic duct and duodenum. In recent years, successful conservative treatment in selected patients with complications have increased. We present a case with successful conservative treatment of rare injury [type 3] developing after ERCP

The effect of proximal anastomosis on the expansion rate of a dilated ascending aorta in coronary artery bypass surgery: a prospective study

Background: This study was designed to determine the short- and long-term effects of proximal aortic anastomosis, performed during isolated coronary artery bypass grafting (CABG) in patients with dilatation of the ascending aorta who did not require surgical intervention.Methods: The study was performed on 192 (38 female and 160 male patients; mean age, 62.1 ± 9.2 years; range, 42­80 years) patients with dilatation of the ascending aorta who underwent CABG surgery between 1 June 2006 and 31 May 2014. In group 1 (n = 114), the saphenous vein and left internal mammarian artery grafts were used, and proximal anastomosis was performed on the ascending aorta. In group 2 (n = 78), left and right internal mammarian artery grafts were used, and proximal aortic anastomosis was not performed. Pre-operatively and in the first and third years postoperatively, the ascending aortic diameter was measured and recorded using transthoracic echocardiography at four different regions (annulus, sinus of Valsalva, sinotubular junction and tubular aorta).Results: A statistically significant difference was found between the groups for the number of grafts used and the duration of aortic cross-clamping and cardiopulmonary bypass. No significant intergroup difference was seen for the mean diameter of the ascending aorta (p > 0.05). Annual changes in the aortic diameter were found to be extremely significantly different in both groups (p = 0.0001). Mean values of the aortic diameter at the level of the sinotubular junction and tubular ascending aorta, mean aortic diameters (p = 0.002 and p = 0.0001, respectively), annual increase in diameter (p = 0.0001 and p = 0.0001, respectively), and mean annual difference in diameter (p = 0.0001 and p = 0.0001, respectively) at one and three years postoperatively were statistically significantly different between the groups.Conclusion: In patients with ascending aortic dilatation who did not require surgical intervention and who had proximal anastomosis of the ascending aorta and underwent only CABG, we detected statistically significant increases in the diameter of the sinotubular junction and tubular aorta up to three years postoperatively

Gangrenous Purpura Fulminans Associated with Influenza A Infection.

Background and Purpose: Purpura fulminans (PF) is a rapidly progressive disease of small-vessel thrombosis and hemorrhagic skin infarctions with high mortality and morbidity. Three forms of disease exist; neonatal, idiopathic and infectious. Infectious one usually appears secondary to gram-negative bacteremia and rarely secondary to viral infections. Case Description: In this paper, we present a 27-year-old female patient with diagnosis of purpura fulminans secondary to Influenza A septicemia which is the first case reported in the literature. Discussion: Several kinds of infection may cause purpura fulminans including rare viral infections so the clinician should be alert to diagnose and to treat purpura fulminans in case of purpuric and hemorrhagic lesions in patients with infectious diseases.

Clinical Features and Prognostic Significance of Limited and Diffuse Endobronchial Sarcoidosis.

Aims: Airway involvement is a common feature of sarcoidosis and mucosal abnormalities may be evident in the respiratory tract. However, firm data establishing the clinical features and prognosis of sarcoidosis in these patients is lacking although the incidence of endobronchial disease is high. The purpose of this study was to evaluate the clinical features of the patients with limited, diffuse and no endobronchial involvement. Another aim was to investigate the prognostic differences between these patients. Methods: We conducted a retrospective study to evaluate the clinical and laboratory findings of 48 patients with endobronchial sarcoidosis and 50 patients without endobronchial involvement seen at our institution. The patients fulfilled the clinical, radiologic or both features of sarcoidosis supported by the histopathologic evidence of noncaseiting granulomas. Six to ten bronchial biopsies were taken from each patient. The sample was considered positive if it demonstrated noncaseiting granulomas with negative fungal and mycobacterial cultures. The patients were classified into three groups according to the histopathologic biopsy results: 1) No endobronchial involvement, 2) Limited endobronchial involvement: One biopsy site positive and 3) Diffuse endobronchial involvement: Two or more biopsy sites positive for noncaseaiting granulomas. Results: Bronchial biopsy was positive in 82% of the abnormal appearing airways while it was diagnostic in 36% of the normal appearing mucosa. The most frequent bronchoscopic appearence was miliary infiltration. Nodular, erythematous lesions and edematous mucosal swelling were other bronchoscopic findings. There were no significant differences between the three groups for FEV1, FVC, TLC, DLCO/VA serum and 24 h urinary calcium levels. Serum ACE levels were significantly higher (p<0.001) in patients with limited and diffuse bronchial involvement compared to patients with no endobronchial disease. The extrapulmonary organ involvement (p<0.001) and progressive disease incidence was more frequent (p<0.001) in patients with limited and diffuse endobronchial disease. Conclusions: Endobronchial involvement in sarcoidosis appears to be a significant predictive risk factor for progressive disease. Patients with limited or diffuse endobronchial disease have more severe extrapulmonary organ involvement and a worse prognosis than patients without endobronchial disease. Bronchoscopy may identify such patients carrying a risk factor for progressive sarcoidosis.

Clinical Features and Prognostic Significance of Endobronchial Sarcoidosis.

Aims: Endobronchial involvement may occur in patients with sarcoidosis. Although the prevalence of bronchial abnormalities is high, there are no firm data establishing the clinical features and prognosis of sarcoidosis in these patients. The aim of our study was to define the clinical characteristics and prognosis of patients with endobronchial sarcoidosis. Methods: Clinical and laboratory findings of 44 patients with endobronchial sarcoidosis and 46 patients without endobronchial involvement seen at our institution, were evaluated retrospectively. The patients fulfilled clinical, radiologic or both features of sarcoidosis supported by the histopathologic evidence of noncaseating granulomas. Six to ten bronchial biopsies were taken from each patient. The sample was considered positive if it demonstrated noncaseiting granulomas with negative bacterial, fungal and mycobacterial cultures. Results: Bronchial biopsy was more positive in 84% of the abnormal appearing airways, biopsy provided diagnostic tissue in 32% of the normal appearing mucosa. The most frequent bronchoscopic finding was miliary infiltration followed by nodular and erythematous lesions. Serum ACE, serum and urinary Ca levels were higher (51.4±14.3 IU/L vs 37.3±15.1 IU/L, p<0.01; 8.42±3.6 mg/dL vs 10.8±2.9 mg/dL, p<0.01; 244.9±32.4 mg/day vs 379.6±36.8 mg/day, p<0.01) in patients with endobronchial involvement. There was no significant difference between FEV1, FVC, TLC and DLCO/VA. The extrapulmonary organ involvement (p<0.02) and progressive disease (p<0.03) was more frequent in patients with endobronchial disease. Conclusion: Endobronchial involvement in sarcoidosis appears to be a significant predictive risk factor for progressive disease. Extrapulmonary organ involvement was also higher in these patients contributing to a worse prognosis.

Left Atrial Thrombus in a Patient with Mitral Bioprosthetic Valve

No abstract available.

Presenting clinical features and outcome in intussusception.

OBJECTIVE: To evaluate if a correlation exists between the clinical and radiologic characteristics at presentation; and the success of conservative management, morbidity and outcome of patients with intussusception. METHODS: All patients (total 179) treated for intussusception in our unit between 1993 and 2003, were retrospectively reviewed to find out the effects of physical examination (general appearance, consciousness, body temperature, abdominal distention and tenderness, blood on rectal examination), laborat (leukocyte count) and radiologic (air-fluid level on X-ray, free abdominal fluid on ultrasonography) findings on selection of first step therapeutic modality, conservative management (reduction with barium or air) success rate and surgical complication (serosal defect, intestinal perforation) rate. Additionally, the patients were subdivided into three subgroups as group A (patients for whom surgical management was performed primarily), group B (the ones who were operated after failure of reduction attempt with barium or air), group C (patients who had successful conservative reduction). These groups were compared within each other with regard to duration of nasogastric suction, antibiotic therapy; onset of oral feeding and duration of hospitalization. The chi-square, Kruskal-Wallis and ANOVA tests were used for the statistical analysis and p value less than 0.05 was considered to be significant. RESULTS: Incidence of selecting conservative treatment primarily was lower in patients with toxic appearance (p=0.02) and with free fluid on ultrasonography (p=0.007). Success rate of conservative treatment was lower in patients with moderate general appearance (p=0.000), lethargy (p=0.011), blood on rectal examination (p=0.004), air-fluid level on X-ray (p=0.039), free fluid on ultrasonography (p=0.001). Surgical complication rate was higher in patients with moderate general appearance (p=0.000), lethargy (p=0.007), air-fluid level on radiograph (p=0.009). In group A; the duration of N/G suction, antibiotic therapy and hospitalization was longer; the onset of oral feeding was later than the other two groups (p=0.000). In group B; the duration of N/G suction, antibiotic therapy and hospitalization was longer; the onset of oral feeding was later than group C (p=0.000). CONCLUSION: Toxic appearance, lethargy and air-fluid level on radiograph not only decrease the success rate of conservative management, but increase the surgical complication rate as well. Thus, these parameters deserve more importance in the management scheme. Reduction with conservative management is the most important factor which decreases the morbidity. Morbidity is lower in cases who are operated after failure of conservative management than the ones for whom surgery is performed primarily. Thus, conservative management should be tried for all patients unless there is a clear cut contraindication such as peritonitis and/or pneumoperitoneum.

How do different presenting and therapeutic modalities change the outcome in intussusception.

OBJECTIVE: To evaluate if a correlation exists between the clinical and radiologic characteristics at presentation; and the success of conservative management, morbidity and outcome of patients with intussusception. METHODS: All patients (total 179) treated for intussusception in our unit between 1993 and 2003, were retrospectively reviewed to find out the effects of physical examination (general appearence, consciousness, body temperature, abdominal distention and tenderness, blood on rectal examination), laborat (leukocyte count) and radiologic (air-fluid level on X-ray, free abdominal fluid on ultrasonography) findings on selection of first step therapeutic modality, conservative management (reduction with barium or air) success rate and surgical complication (serosal defect, intestinal perforation) rate. Additionally, the patients were subdivided into three subgroups as group A (patients for whom surgical management was performed primarily), group B (the ones who were operated after failure of reduction attempt with barium or air), group C (patients who had successful conservative reduction). These groups were compared within each other with regard to duration of nasogastric suction, antibiotic therapy; onset of oral feeding and duration of hospitalization. The chi-square, Kruskal-Wallis and ANOVA tests were used for the statistical analysis and p value less than 0.05 was considered to be significant. RESULTS: Incidence of selecting conservative treatment primarily was lower in patients with moderate general appearence (p=0.02) and with free fluid on ultrasonography (p=0.007). Success rate of conservative treatment was lower in patients with moderate general appearence (p=0.000), lethargy (p=0.011), blood on rectal examination (p=0.004), air-fluid level on X-ray (p=0.039), free fluid on ultrasonography (p=0.001). Surgical complication rate was higher in patients with moderate general appearence (p=0.000), lethargy (p=0.007), air-fluid level on X-ray (p=0.009). In group A; the duration of N/G suction, antibiotic therapy and hospitalization was longer; the onset of oral feeding was later than the other two groups (p=0.000). In group B; the duration of N/G suction, antibiotic therapy and hospitalization was longer; the onset of oral feeding was later than group C (p=0.000). CONCLUSION: Moderate general appearence, lethargy and air-fluid level on X-ray not only decrease the success rate of conservative management, but increase the surgical complication rate as well. Thus, these parameters deserve more importance in the management scheme. Reduction with conservative management is the most important factor which decreases the morbidity. Morbidity is lower in cases who are operated after failure of conservative management than the ones for whom surgery is performed primarily. Thus, conservative management should be tried for all patients unless there is a clear cut contraindication such as peritonitis and/or pneumoperitoneum.

Assessing the quality of randomized controlled trials from two leading cancer journals using the CONSORT statement

No study has been conducted on the scientific quality of randomized controlled trials [RCTs] in the cancer field. Our objective was to determine whether adherence to the Consolidated Standards for Reporting Trials [CONSORT] statement is associated with scientific properties of RCT reports from two leading cancer journals. We conducted an observational study of RCTs published between 2002 and 2004 in two leading cancer journals that did not endorse the CONSORT statement during that period. We determined the adherence rates with confidence intervals of 33 RCTs according to the 19 methodological items of the CONSORT statement. Each RCT was blindly assessed by three independent evaluators; then the evaluators examined all judgments sequentially and obtained a consensus regarding each methodological item of the CONSORT statement. The average adherence of these 33 RCTs to the 19 methodological items of the CONSORT statement was 79.3% [95% CI, 75.3-83.4%]. Most descriptors from the checklist were determined to be methodologically adequate except sequence generation [56.1%; 95% CI, 40.9-71.3%], allocation concealment [27.3%; 95% CI, 13.2-41.4%], implementation [7.6%; 95% CI, 0.0-15.4%], blinding [30.3%; 95% CI, 14.4-46.3%] and sample size [74.2%; 95% CI, 59.5-89.0%]. Of all CONSORT checklist items, randomization implementation was the most often omitted. Some key methodological items of the CONSORT statement seem poorly addressed in RCTs from these leading cancer journals. Thus researchers should be urged to conform to the CONSORT statement when reporting on RCTs, and the poorly addressed items of the CONSORT statement should be reevaluated for RCTs already reported

Evaluating "superiority", "equivalence" and "non-inferiority" in clinical trials

Clinical studies are usually performed with the aim of justifying that a new treatment approach is "superior" to the common standard approach [active control] with respect to benefits. In a general sense, this justification is carried out on the basis of the "null hypothesis significance test" with the P value based on this test used for justification. Today, new drugs differ so little from existing ones that factors such as cost and side effects affect the choice of therapy, when the bioavailability of treatment methods are found equivalent. Therefore, the aim of comparative clinical trials has extended beyond showing that a treatment is "superior" and now attempts to show that new treatments are "equal" and "non-inferior" to existing treatments. New approaches have become necessary since the classical null hypothesis approach is insufficient to justify the use of new agents, especially in cases of "equivalence" and "non-inferiority". This new approach to justification makes use of the "clinical equivalence interval", which determines the limits of the differences between specific endpoints that can be regarded as clinically "equal" to the value that was pre-specified based on studies of established therapies. It also makes use of the quantitative-based "confidence intervals" as the criteria for statistical justification. Many analyses can be done confidently when these tools are applied and the data are interpreted correctly

prevalence and the age at the onest of menopause in Turkish women in rural aera

To find out the prevalence of natural menopause among Turkish women according to age and certain demographic variables in a specific rural area. This cross sectional study was carried out in Silivri district of Istanbul, Turkey between January and May 2000. Included in the study were 845 women between the ages of 30-60 years, not undergoing any hormonal replacement, living in the villages of Silivri district, Istanbul, Turkey. The participants were asked for their ages, level of education, number of pregnancies, age at menarche, presence of menstruation, age at the onset of menopause, physical activity outside home and the use of oral contraceptives. Females declaring at least one year of amenorrhea were accepted as being in menopause. The median age for menopause was 47 years. Of the total 845 participants, 326 women were found to be in natural menopause. The prevalence of menopause was estimated as 8.6% for females younger than 40 years, 31.8% for females between the ages 40-45 years and 80.9% among females older than 45 years. Any of the variables questioned in our study have an effect on premature onset of menopause, but we found that never been pregnant [p=0.037, odd ratio [OR]=2.221, 95% confidence interval [CI]=1.048, 4.707] reduces the reproductive period, and the age at menarche younger than 13 prevents early menopause [p=0.000, OR=0.336, 95% CI=0.195, 0.579]. Furthermore, both lead to early onset of menopause. Hazard ratios of the variables that have an effect on the onset of early menopause are calculated as 2:10 [95% CI=1.01, 4.39] for those who were never been pregnant and 1:10 for those with the menarche ages over 13 years [95% CI=0.68, 1.78]. There was a noticeably high percentage of females [8.6%] younger than 40 years who were entering menopause. On the other hand, an early onset of natural menopause among Turkish women living in this rural area was found to be associated with never been pregnant and their age of menarche