Tag: statistics

Medicine (Baltimore). 2022 Sep 2;101(35):e30355. doi: 10.1097/MD.0000000000030355.

ABSTRACT

INTRODUCTION: Low-volume bowel preparation has been developed to increase patient compliance. We compared 1 L of polyethylene glycol/ascorbic acid (PEG/Asc) and oral sodium sulfate (OSS) with respect to bowel preparation efficacy, compliance, and safety.

METHODS: A multicenter, prospective, randomized, single-blinded, non-inferiority trial was conducted in 3 hospitals. Patients were randomized to receive a bowel-cleansing agent. Bowel-cleansing efficacy was evaluated using the Boston Bowel Preparation Scale (BBPS). Satisfaction, feeling, taste of the bowel cleanser, and adverse events after taking the bowel cleanser were investigated through a questionnaire. Additionally, blood samples were analyzed before and after bowel cleansing.

RESULTS: In total, 172 patients were analyzed (85 with 1 L PEG/Asc and 87 with OSS), and the mean BBPS scores were comparable between agents. The 1L PEG/Asc group tended to have a higher BBPS score in the right colon (2.22 vs 2.02; P = .08). The compliance of 1 L of PEG/Asc was comparable to that of OSS. Patients taking 1 L PEG/Asc reported greater thirst and dizziness (P = .04 and P = .047, respectively) than the OSS cohort. On the other hand, gastrointestinal symptoms such as vomiting and abdominal distension were more common in the OSS group, without statistical significance. In terms of laboratory adverse events, elevation of serum creatinine was found in both groups after taking the bowel cleansing agent (P < .001 for the 1L PEG/Asc group; P = .04 for the OSS group). However, most of the increased values were within the normal ranges.

DISCUSSION: The 1L PEG/Asc treatment was comparable to OSS in terms of bowel preparation efficacy, compliance, and safety.

PMID:36107563 | DOI:10.1097/MD.0000000000030355

Medicine (Baltimore). 2022 Sep 2;101(35):e30073. doi: 10.1097/MD.0000000000030073.

ABSTRACT

BACKGROUND: The respiratory system is the first line of defense against outside pollutants. Recently, respiratory health has been receiving increasing attention due to the increase in fine dust, which reduces respiratory function and increases incidence of chronic obstructive pulmonary disease, and in coronavirus pandemic, which can cause severe acute respiratory syndrome.

METHODS: This clinical pilot trial was designed to secure evidence for a main clinical trial and to confirm the efficacy and safety of Liriope platyphylla (LP) extract for improving respiratory function. We conducted a double-blind randomized placebo-controlled trial with 22 participants from June 30, 2021, to August 25, 2021. The primary outcome was Breathlessness, Cough, and Sputum Scale score. Secondary outcomes included forced vital capacity, forced expiratory volume at 1 second (FEV1), forced expiratory volume at 1 s/forced vital capacity ratio, cough assessment test score, chronic obstructive pulmonary disease assessment test score, peripheral blood mononuclear cell counts (white blood cells, eosinophils, T cells, and B cells), high-sensitivity C-reactive protein level, erythrocyte sedimentation rate, cytokine (interleukin-1β, interleukin-4, tumor necrosis factor-α, interleukin-6, interleukin-8, interferon-γ, and immunoglobulin E) levels, antioxidant (glutathione peroxidase and superoxide dismutase) levels, and nitric oxide level.

RESULTS: A total of 22 participants were randomly assigned to 2 groups: the LP group (n = 11), who took 1000 mg of LP extract per day, and the placebo group, who took 1000 mg of dextrin per day. Participants took 1 capsule twice a day for 4 weeks. For the Breathlessness, Cough, and Sputum Scale, the interaction between group and visit was statistically significant in a blend of analyses of variance. interleukin-8, tumor necrosis factor-α, and interferon-γ levels decreased more in the LP group than in the placebo group. The sample size required for large-scale clinical trials in the future was 50. There were no side effects.

CONCLUSION: LP extract can enhance respiratory function. The detailed data we obtained support conducting the future main large-scale clinical trial.

PMID:36107535 | DOI:10.1097/MD.0000000000030073

Medicine (Baltimore). 2022 Sep 2;101(35):e30118. doi: 10.1097/MD.0000000000030118.

ABSTRACT

Inflammatory bowel disease (IBD) is characterized by many clinical features. Anemia is 1 of the most frequent complications and/or extraintestinal manifestations of IBD. There are conflicting data regarding the relationship between changes in hemoglobin levels and disease prevalence in IBD patients with and without antitumor necrosis factor (antiTNF) therapy. In our study, we aimed to investigate the long-term effect of antiTNF agents on anemia in IBD. The records of IBD patients followed-up in our hospital between January 2011 and January 2021 were reviewed retrospectively. Demographic, clinical, endoscopic, radiological and medical treatment data of the patients were recorded. Complete blood count and laboratory markers of inflammation and disease activation, were recorded at the beginning and at the first year of treatment in all patients. The data of patients with and without antiTNF therapy were analyzed statistically. A total of 240 IBD patients who met the inclusion criteria were enrolled in the study. The number of patients with and without antiTNF therapy was 102 (42.5%) and 138 (57.5%), respectively. The change in all laboratory parameters between the beginning and the first year of treatment was statistically significant (P < .001) in all IBD patients with and without antiTNF therapy. The change in Hb level after 1 year of treatment was significantly different in patients with antiTNF therapy compared to those without therapy (3.00 ± 1.78 g/dL vs 1.19 ± 1.38 g/dL, P < .001). In the multiple regression analysis, male gender, antiTNF therapy, baseline Hb level and iron therapy were independent significant variables of hematopoietic response. This study showed that with appropriate treatment, hemoglobin levels of IBD patients with and without antiTNF therapy increased within 1 year, and the use of antiTNF agents in the treatment of IBD was an independent variable in correcting anemia.

PMID:36107528 | DOI:10.1097/MD.0000000000030118

Medicine (Baltimore). 2022 Sep 2;101(35):e30198. doi: 10.1097/MD.0000000000030198.

ABSTRACT

Secondary lymphedema is a clinically incurable disease that commonly occurs following surgical cancer treatment and/or radiation. One of the most common forms of lymphedema treatment is complete decongestive therapy (CDT). This study aimed to investigate the clinical effects of new compression bandages (Mobiderm® bandages) in patients with secondary lymphedema after cancer treatment. This study included 17 patients with ipsilateral limb lymphedema after cancer treatment (one male and 16 female patients; age, 45-80 years). Patients were divided into the Mobiderm® bandage group (n = 9) and classical bandage group (n = 8). The International Society of Lymphology (ISL) stage was also evaluated. Limb circumference was measured at 5 to 6 sites per limb to identify the maximal circumference difference (MCD) between the affected and unaffected limbs. Pre-and posttreatment MCD were analyzed. After intensive CDT, both the Mobiderm® bandage group (1.2 ± 0.56 cm) and classical bandage group (0.85 ± 0.40 cm) had a significant decrease in MCD compared to pretreatment (P < .05). However, in patients with ISL stage 2, the mean MCD decrease rate was greater in the Mobiderm® bandage group (22.82 ± 10.92 %) than in the classical bandage group (12.18 ± 8.1 1%)(P = .045). Both new bandages (Mobiderm® bandages and classical bandages) reduced the circumference of limb edema in patients with secondary lymphedema after cancer treatment. This study findings suggest that Mobiderm® bandages as an alternative modality for controlling ISL stage 2 lymphedema.

PMID:36107527 | DOI:10.1097/MD.0000000000030198

Medicine (Baltimore). 2022 Sep 2;101(35):e30146. doi: 10.1097/MD.0000000000030146.

ABSTRACT

BACKGROUND: There is currently no objective computed tomography (CT)-defined grading system for coronavirus disease (COVID-19)-related pulmonary fibrosis. We propose a CT-based radiological scale that adapts the histological fibrosis scale to pulmonary fibrosis CT findings, to evaluate possible predictive factors for the degree of fibrosis in these patients.

METHODS: A new radiological fibrosis grading system was created based on existing histological fibrosis scales. One hundred forty-seven COVID-19 patients with any degree of fibrosis on CT were evaluated. Smoking status, the presence of hypertension, the duration of hospital stays, the presence of comorbid diseases, and the levels of prognostic and predictive factors for COVID-19 were evaluated, and how these parameters affected the fibrosis scores was examined.

RESULTS: Of 147 patients, 17.7% had grade 1, 17% had grade 2, 51.7% had grade 3, and 13.6% had grade 4 fibrosis. ANOVA revealed statistically significant relationships between the fibrosis scores and lactate dehydrogenase values, lymphocyte count, C-reactive protein level, and length of hospital stay. Smoking, advanced age, hypertension, and male sex showed significantly higher scores for fibrosis.

CONCLUSIONS: Using our CT-defined lung fibrosis grading system, we could predict the severity of fibrosis as well as the resultant lung pathology in COVID-19 patients. Thus, disease exacerbation and development of permanent severe fibrosis can be prevented using the appropriate treatment methods in high-risk patients.

PMID:36107526 | DOI:10.1097/MD.0000000000030146

Medicine (Baltimore). 2022 Sep 2;101(35):e30105. doi: 10.1097/MD.0000000000030274.

ABSTRACT

Total knee replacement (TKR) is associated with a large amount of bleeding; therefore, the prevalence of postoperative anemia is high. In particular, patients with chronic kidney disease (CKD) are more vulnerable to postoperative anemia than are healthy individuals. Accordingly, the effect of intraoperative intravenous ferric derisomaltose (FDI) supplementation on postoperative anemia and blood transfusion volume reduction in patients with CKD was studied. Patients who underwent unilateral TKR between January 2019 and December 2020 were retrospectively reviewed. In analyzing the data, the patients fell into the CKD group (n = 85) and the non-CKD group (n = 106). Each group was divided into a group using FDI and a non-FDI group, and classified into 4 groups. The postoperative hemoglobin level for each postoperative day (POD) was determined as the primary outcome. In addition, the patient transfusion rate, volume of transfusion, and length of hospital stay were set as secondary study outcomes during the period from surgery to discharge. There was no statistically significant difference in hemoglobin levels on PODs 0, 1, 2, 7, and 14 in the CKD group. In the CKD group, the transfusion volume of the FDI group was 0.58 ± 0.91 units per person, which was statistically significantly lower than 1.28 ± 1.28 units of the non-FDI group (P = .01). In the CKD group, the transfusion rate of the FDI group was 30.2%, which was statistically significantly lower than that of the non-FDI group, which was 56.3% (P = .02). This study showed that intravenous FDI supplementation after TKR in CKD patients did not reduce postoperative anemia but was an effective and safe treatment to reduce transfusion volume and transfusion rate. There was no statistically significant difference in hemoglobin levels on POD 0, 1, 2, 7, and 14 in the non-CKD group. In the non-CKD group, the transfusion volume of the FDI group was 0.46 ± 0.88 units per person, which was lower than the 0.56 ± 0.91 units of the non-FDI group, but it was not statistically significant (P = .59). In the non-CKD group, the transfusion rate of the FDI group was 23.0%, which was lower than that of the non-FDI group, which was 31.3%, but it was not statistically significant (P = .37).

PMID:36107525 | DOI:10.1097/MD.0000000000030274

Medicine (Baltimore). 2022 Sep 2;101(35):e30162. doi: 10.1097/MD.0000000000030162.

ABSTRACT

A mesh is usually employed to cover defects when performing laparoscopic totally extraperitoneal repair (TEP) of inguinal hernias. However, there is insufficient evidence for an appropriate mesh size. Therefore, we aimed to compare the recurrence rate between large- and medium-mesh laparoscopic TEP. Patients who underwent laparoscopic TEP for primary inguinal hernias from January 2012 to March 2020 were included. We retrospectively reviewed electric medical records. The primary outcome was the difference in recurrence rate between the large and medium meshes. The large mesh was 10.3 × 15.7 cm, and the medium mesh was 7.9 × 13.4 cm or 9 × 13 cm. In total, 446 patients were included in the study. Of these patients, 177 were in the large-mesh group, and 269 were in the medium-mesh group. The average ages of the large- and medium-mesh groups were 58.4 and 56.9 years, respectively (P = .361). In both groups (large vs medium), males were dominant (93.2% vs 93.6%, P = .850), and indirect hernias (87.0% vs 88.1%, P = .740) were dominant. There was no difference in body mass index (P = .883) or hernia side (P = .770). Peritoneal tearing as an intraoperative complication occurred frequently in the large-mesh group (13.6% vs 3.3%, P < .001). During the mean follow-up period of 28 months, recurrence occurred in 3 (1.7%) and 13 (4.8%) patients in the large- and medium-mesh groups, respectively. However, there was no statistical significance (P = .262). Mesh size may not affect recurrence after laparoscopic TEP of primary inguinal hernias.

PMID:36107522 | DOI:10.1097/MD.0000000000030162

Diabetes. 2022 Sep 15:db220264. doi: 10.2337/db22-0264. Online ahead of print.

ABSTRACT

Reports indicate that COVID-19 may impact pancreatic function and increase type 2 diabetes (T2D) risk, although real-world COVID-19 impacts on HbA1c and T2D are unknown. We tested whether COVID-19 increased HbA1c, risk of T2D, or diabetic ketoacidosis (DKA). We compared pre- and post-COVID-19 HbA1c, and T2D risk in a large real-world clinical cohort of 8,755 COVID-19(+) patients and 11,998 COVID-19(-) matched controls. We investigated if DKA risk was modified in COVID-19(+) patients with type 1 diabetes (T1D) (N=701) or T2D (N=21,830), or by race and sex. We observed a statistically significant, albeit clinically insignificant, HbA1c increase post-COVID-19 (all patients △HbA1c=0.06%; with T2D △HbA1c=0.1%), and no increase among COVID-19(-) patients. COVID-19(+) patients were 40% more likely to be diagnosed with T2D compared to COVID-19(-) patients and 28% more likely for the same HbA1c change as COVID-19(-) patients, indicating that COVID-19 attributed T2D risk may be due to increased recognition during COVID-19 management. DKA in COVID-19(+) patients with T1D was not increased. COVID-19(+) Black patients with T2D displayed disproportionately increased DKA risk (HR:2.46[1.48-6.09], P=0.004) compared to White patients, suggesting a need for further clinical awareness and investigation.

PMID:36107493 | DOI:10.2337/db22-0264

Occup Ther Health Care. 2022 Sep 15:1-14. doi: 10.1080/07380577.2022.2121992. Online ahead of print.

ABSTRACT

Satisfaction of 81 patients was evaluated before and after receiving occupational therapy services. There was a statistically significant difference between patients’ scores before and after receiving occupational therapy services (p < .05). Over 85% indicated a high satisfaction in relation to quality and health outcomes attributed to occupational therapy services, 44% reported barriers related to limited availability, accessibility, and knowledge of occupational therapy services, and 35% made suggestions for improvements. Patient-therapist communication and easy access to occupational therapy services can enhance occupational therapy knowledge, lead to positive patient experience and quality health outcomes, and higher patient satisfaction.

PMID:36107489 | DOI:10.1080/07380577.2022.2121992

Nephrol Dial Transplant. 2022 Sep 15:gfac271. doi: 10.1093/ndt/gfac271. Online ahead of print.

ABSTRACT

BACKGROUND: Calciprotein particles (CPP), colloidal mineral-protein nanoparticles, have emerged as potential mediators of phosphate toxicity in dialysis patients, with putative links to vascular calcification, endothelial dysfunction, and inflammation. We hypothesized that phosphate binder therapy with sucroferric oxyhydroxide (SO) would reduce endogenous CPP levels, and attenuate pro-calcific and pro-inflammatory effects of patient serum towards human vascular cells in vitro.

METHODS: This secondary analysis of a randomized, controlled cross-over study compared the effect of two-week phosphate binder washout with high-dose (2000 mg/d) and low-dose (250 mg/d) SO therapy in 28 hemodialysis patients on serum CPP levels, inflammatory cytokine/chemokine arrays, and human aortic smooth muscle cell (HASMC) and coronary artery endothelial cell (HCAEC) bioassays.

RESULTS: In our cohort (75% male, 62 ± 12 years) high-dose SO reduced primary (amorphous) and secondary (crystalline) CPP levels [-62 (-76 to -44)%, P < 0.0001 and -38 (-62 to -0.14)%, P < 0.001, respectively] compared with washout. Nine of 14 plasma cytokines/chemokines significantly decreased with high-dose SO, with consistent reductions in Interleukin-6 (IL-6) and IL-8. Exposure of HASMC and HCAEC cultures to serum of SO-treated patients reduced calcification and markers of activation (IL-6, IL-8, and vascular cell adhesion protein 1) compared with washout. Serum-induced HASMC calcification and HCAEC activation was ameliorated by removal of the CPP-containing fraction from patient sera. Effects of CPP removal were confirmed in an independent cohort of chronic kidney disease patients.

CONCLUSIONS: High-dose SO reduced endogenous CPP formation in dialysis patients and yielded serum with attenuated pro-calcific and inflammatory effects in vitro.

PMID:36107466 | DOI:10.1093/ndt/gfac271