PATIENTS AND METHODS Sample Clauses
The "Patients and Methods" clause defines the criteria for selecting study participants and outlines the procedures and methodologies used in a clinical or research study. It typically details the inclusion and exclusion criteria for patients, describes how data will be collected, and specifies the interventions or assessments to be performed. By clearly stating these elements, the clause ensures transparency and reproducibility in research, allowing others to understand how the study was conducted and to assess the validity of its results.
PATIENTS AND METHODS. The PiKo-1 (Ferraris Cardiorespiratory, Louisville, CO, USA) is a lightweight, small, inexpensive electronic sensing device that can measure PEF and FEV1. The device can store 96 readings and report errors in the procedure. The reading itself is displayed along with a corresponding color zone, which can be adjusted according to the reference values. Data stored in the device can also be transferred to a computer or transmitted to other units1 (Figure 1). The Masterlab pneumotachograph (▇▇▇▇▇▇ ▇▇, Würzburg, Germany) is a device that is widely used in clinical practice for measuring spirometric variables. However, the size of the device is a hindrance, and personnel with specific training are required. For these reasons, other devices, such as the PiKo-1 are under development. The aim is to make these devices easier to operate so that, once their readings have been shown to agree with those of the pneumotachograph, physicians can use them in the clinical practice. In clinical research, the reliability of a device is usually assessed by comparing the results with those of another one widely used in clinical practice for agreement or discrepancies. If a more practical alternative to the reference device becomes available, the agreement between systems should be determined. When a variable in a comparative analysis is continuous and quantitative, the intraclass correlation coefficient (ICC) is more appropriate than the ▇▇▇▇▇▇▇ correlation coefficient (r), as it can indicate general agreement between 2 or more methods of measurement or different observations.8 Another simple and visual method is the so-called ▇▇▇▇▇-▇▇▇▇▇▇ analysis to assess agreement between 2 systems of measurement.9 We have undertaken a randomized, single-blind, cross- sectional study of agreement between 2 measurement devices in a specialist care setting—the lung function testing laboratory of the Hospital General Yagüe in Burgos, Spain, at 867 m above sea level. Patients were recruited from those attending our specialist laboratory between March 15 and April 24, 2004 for lung function testing. Patients aged between 20 years and 80 years were included, and those who did not understand the technique after a brief explanation were excluded in order to avoid procedural errors. A table of random numbers was used to select patients from among those who attended the lung function testing laboratory and who met the inclusion criteria. A sample size of 40 patients was calculated to be sufficient to d...
PATIENTS AND METHODS. This randomized, single-blind study included 40 patients who attended the clinic for lung function testing. The 2 measurement devices were the Masterlab pneumotachograph and the PiKo-1. A correction factor estimated by the manufacturer was applied to the measurements taken with the PiKo-1.
PATIENTS AND METHODS. Participants
PATIENTS AND METHODS. Patients The study was approved by the hospital ethics committee and was conducted according to the principles stated in the Helsinki convention. Written informed consent was obtained the day before surgery. Fifteen patients (11 men and 4 women, mean age 73 years) scheduled to undergo elective cardiac surgery on cardiopulmonary bypass (11 patients with CAGB and 4 patients with mitral valve annuloplasty) were included in the study. Patients with significant valvular regurgitation and/or atrial fibrillation, aneurismal deformities to the aorta or symptomatic peripheral vascular disease were excluded. Patients were pre-medicated with sublingual lorazepam (0.05mg/kg). Radial arterial blood pressure was monitored via a 20 Gauge, 3.8 ▇▇ ▇▇▇▇ radial catheter inserted by Seldinger technique and connected to a pressure Data analysis
PATIENTS AND METHODS. Drug formulation Study design Eligibility criteria
PATIENTS AND METHODS. This study is approved by the Local Ethics Committee (Approval number: 4/2023). Between 2020 and 2023, a total of 64 needle liver biopsies were included in this study. Biopsy reports were retrieved from the electronic archive. These biopsies had been reported by seven pathologists working in our department who received specialized training from different centers. Ten reports from each of six pathologists were included in the study. The seventh pathologist, who had recently joined the study, had only four biopsies meeting the criteria and was not evaluated individually. All biopsies had received a diagnosis of chronic hepatitis and were scored according to the Modified Ishak Histological Activity Index (MHAİ) (Table 1). Sections stained with hematoxylin-eosin, silver, and trichrome were retrieved from the archives and re-evaluated by the researcher (İÇ) under a light microscope. They were then rescored according to the MHAİ. The data were compared with the values from the previously prepared reports. In the initial evaluation, the researcher scores were compared to all other biopsies (n=64) (Table 2). Subsequently, the scores from the researcher and those from the six pathologists were compared individually (n=10) (Table 3). Statistical analysis was performed using SPSS 21.0, applying ▇▇▇▇▇'▇ kappa statistic. The results were evaluated by categorizing them into standard categories as follows (6). ▇▇▇▇▇’▇ Kappa İnterpretation <0 poor 00-0.20 slight 0.21-0.40 fair 0.41-0.60 moderate 0.61-0.80 substantial 0.81- 1.00 almost perfect In the statistical evaluation, considering all cases, the kappa value for the MAI degree was 0.02 (slight), and for the stage, it was 0.38 (fair). When considering individual parameters, the lowest kappa value was found for B (confluent necrosis), while the highest kappa value was observed in the D (portal inflammation) category (Table 3). When evaluating the researcher's agreement with other pathologists separately, the kappa values for grading were quite low, indicating poor agreement. For staging, there were relatively higher values (ranging from 0.12 to 0.49), indicating fair to moderate agreement. Substantial agreement (0.72) was observed with one observer (P4). Among the parameters, the highest agreement was found in the assessment of portal inflammation (D), while the weakest agreement was observed in the assessment of confluent necrosis. The MHAİ grading was also evaluated as diagnostic categories. In this case (score 1-3 min...
PATIENTS AND METHODS. To investigate agreement between indirect calorimetry and several REE estimating equations in 38 ESRD patients on peritoneal dialysis, we performed indirect calorimetry and compared the results with ▇▇▇▇ estimated using 5 equations [▇▇▇▇▇▇-▇▇▇▇▇▇▇▇ (HBE), Mifflin, WHO, ▇▇▇▇▇▇▇▇▇, and ▇▇▇▇▇▇▇▇▇▇]. Results: ▇▇▇▇▇▇▇▇ ▇▇▇ was 1393.2 ± 238.7 kcal/day. There were no significant differences between measured and estimated ▇▇▇▇ except Mifflin (1264.9 ± 224.8 kcal/day). Root mean square errors were smallest for HBE, followed by ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, and WHO, and largest for Mifflin (171.3, 171.9, 174.6, 175.3, and 224.6, respectively). In ▇▇▇▇▇-▇▇▇▇▇▇ plot, correlation coefficients between mean values and differences were significant for HBE (r = 0.412, p = 0.012) and tended to be significant for ▇▇▇▇▇▇▇▇▇▇ (r = 0.283, p = 0.086). In DM patients and patients with overhydration, HBE showed signi- ficant underestimation when REE increased.
PATIENTS AND METHODS. From 1996, in the IJsselland hospital, a referral centre for TEM, 88 consecutive patients under- went TEM for pT1 rectal cancer and were followed as part of a prospective, comparative study. As described previously all patients were screened according to a standard protocol.21 The initial TEM procedure was performed by two surgeons. A full-thickness excision was performed in all lesions, and in all tumors a microscopic negative excision margin of 2 millimetres or more was obtained (R0), as shown by protocollized pathology. None of the patients received any form of (neo-) adjuvant treatment. Follow-up was according to the Dutch guidelines on rectal cancer with additional rigid rectoscopy and endorectal ultrasound (ERUS) every 3 months the first 2 years, and every 6 months thereafter for the detection of local recurrences. During the last two years of the study period magnetic resonance imaging (MRI) of the lesser pelvis was introduced as a part of the follow-up as well, and nowadays is routinely performed at 12, 24 and 36 months. A local recurrence was defined as recurrent tumorous tissue within the lesser pelvis and endoluminal, if present, within the proximity of the scar tissue of the initial operation. All recurrences were histologically proven and when appropriate, salvage surgery was performed. Initially patients were treated without neo-adjuvant treatment (five patients), later on with preoperative short-course radiotherapy (six patients) and nowadays with preoperative long- course chemoradiotherapy (five patients). Following salvage surgery, patients were followed according to the Dutch guidelines for rectal cancer. Patient data were collected in a central, digital database. Patient survival was assessed using the ▇▇▇▇▇▇–▇▇▇▇▇ life-table method. Out of 88 patients followed, in 18 patients a local recurrence occurred. Patient and primary tumor characteristics are depicted in Table 1 and 2. Only three tumors primarily harboured accepted high-risk features, which are poor differentiation and/or (lymph-) vessel invasion. All others were so-called low-risk tumors. Besides these features, of 16 tumors with known submu- cosal invasion depth, six invaded the deep part of the submucosa (Sm3).
PATIENTS AND METHODS. Patients Thirty-seven patients were enrolled to this study, of whom 35 had participated in the previous study (5). The initial diagnosis of acromegaly was based on the characteristic clinical features and confirmed by insufficient suppression of GH during a glucose tolerance test (normal response: GH nadir <0.5 μg/L), an elevated age- and gender-adjusted IGF-I, and the presence of a pituitary adenoma on radiological imaging. Patients were classified at study entry as having active or inactive acromegaly. Active acromegaly (n=18) was defined as: mean fasting GH concentration (measured every 30 minutes for 3 hours) >2.5 μg/L, and an elevated age- and gender-adjusted IGF-I concentra- tion. This study was performed before the introduction of GH receptor blockade drugs. Nineteen patients were classified as inactive acromegaly which was defined in medically well-controlled acromegaly (n=13) as mean fasting GH concentration (measured for 3 hours with an interval of 30 minutes) <2.5 μg/L, and normal age- and gender-adjusted IGF-I concentrations during treatment with depot octreotide acetate (n=13, Novartis Pharma AG, Basel, Switzerland) and in surgically cured acromegaly (n=6) as glucose-suppressed GH <0.5 μg/L, and normal age- and gender-adjusted IGF-I concentration without medical treatment. None of the patients had hemodynamic instability, previous myocardial infarction, thy- reotoxicosis, rheumatic fever, endocarditis, or connective tissue disease. None of the female patients became pregnant during the study period. The local institutional ethics committee approved the study, and written informed consent was obtained from all subjects.
PATIENTS AND METHODS. Preoperative MRIs of 40 consecutive patients with LRRC scheduled for curative treatment between October 2003 and November 2006 were analyzed retrospectively. Four observers with different experience in reading pelvic MRI assessed tumor invasion into the following structures: bladder, uterus/seminal vesicles, vagina/prostate, left and right pelvic walls and sacrum. Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) were calculated and a ROC curve was constructed. Surgical and/or histopathological findings were used as reference standard. Interobserver agreement was measured using kappa statistics. Results: Preoperative MRI was accurate for the prediction of tumor invasion into structures with NPVs of 93 - 100% and AUCs of 0.79 - 1.00 for all structures and observers. PPVs were 53 - 100%. Overstaging occurred in 11 (observer 1), 22 (observer Conclusion: Preoperative MRI is accurate for the prediction of tumor invasion into pelvic structures. MRI may be useful as preoperative road map for the surgical procedure and may thus increase the chance of a complete resection. Interpretation of diffuse fibrosis remains difficult.