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1.
Investigation of The Effects of Oxytocin Administration Timing on Postpartum Hemorrhage during Cesarean Section
Gök S, Kaleli MB
Medicina (Kaunas, Lithuania). 2023;59(2)
Abstract
Background and Objectives: To determine and compare the effects of the timing of oxytocin administration (routinely used for intraoperative uterotonic purposes in cesarean section (CS) deliveries in our clinic) on the severity of postpartum hemorrhage following CS. Materials and Methods: All study participants (n = 216) had previous cesarean deliveries, were 38-40 weeks pregnant, and had CS planned under elective conditions. The cases were randomly divided into two groups: one group (n = 108) receiving oxytocin administration before the removal of the placenta (AOBRP) and another group (n = 108) receiving oxytocin administration after the removal of the placenta (AOARP). In all cases, the placenta was removed using the manual traction method. The standard dose of oxytocin is administered as an intravenous (IV) push of 3 international units (IU); simultaneously, 10 IU of oxytocin is added to 1000 cc isotonic fluid and given as an IV infusion at a rate of 250 cc/h. All methods and procedures applied to both groups were identical, except for the timing of administration of the standard oxytocin dose. Age, body mass index (BMI), parity, gestational week, preoperative hemoglobin (HB) and hematocrit (HTC), postoperative 6th and 24th hour HB-HTC, intraoperative hemorrhage, additional uterotonic need during cesarean section, postoperative hemorrhage (number of pads), need for blood transfusion during or after cesarean section, cesarean section time, and postpartum newborn baby weight were evaluated. Results: Age (year), BMI (kg/m(2)), parity, gestational week, surgical time, and newborn weight (g) did not differ between the groups (p > 0.05). The AOBRP group had significantly higher postoperative 6th hour HB and HTC and postoperative 24th hour HB and HTC values (p < 0.05). The intraoperative hemorrhage level was higher in the AOARP group (p = 0.000). Conclusions: The administration of oxytocin before placenta removal did not change the volume of bleeding in the postoperative period but significantly reduced the volume of bleeding in the intraoperative period. Therefore, in the postoperative period, the HB and HTC values of the AOBRP group were higher than those of the AOARP group.
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2.
The Influence of Industry Affiliation on Randomized Controlled Trials of Platelet-Rich Plasma for Knee Osteoarthritis
Ta CN, Vasudevan R, Mitchell BC, Keller RA, Kent WT
The American journal of sports medicine. 2023;:3635465221140917
Abstract
BACKGROUND Industry funding and corporate sponsorship have played a significant role in the advancement of orthopaedic research and technology. However, this relationship raises concerns for how industry association may bias research findings and influence clinical practice. PURPOSE To determine whether industry affiliation plays a role in the outcomes of randomized controlled trials (RCTs) investigating platelet-rich plasma (PRP). STUDY DESIGN Meta-analysis; Level of evidence, 2. METHODS A search of the PubMed, Cochrane, and MEDLINE databases for RCTs published between 2011 and the present comparing PRP versus hyaluronic acid, corticosteroid, or placebo for the treatment of knee osteoarthritis was performed. To determine industry affiliation, the conflict of interest, funding, and disclosure sections of publications were assessed, and all authors were assessed through the American Academy of Orthopaedic Surgeons disclosure database and the Centers for Medicare & Medicaid Services open payments database. Studies were classified as industry affiliated (IA) or non-industry affiliated (NIA). The outcomes of each study were rated as favorable, analogous, or unfavorable according to predefined criteria. RESULTS A total of 37 studies (6 IA and 31 NIA) were available for analysis. Overall, 19 studies (51.4%) reported PRP as favorable compared with other treatment options, while 18 studies (48.6%) showed no significant differences between PRP and other treatment methods. There was no significant difference in qualitative conclusions between the IA and NIA groups, with the IA group having 3 favorable studies and 3 analogous studies and the NIA group having 16 favorable studies and 15 analogous studies (P = .8881). When comparing IA versus NIA studies using 6- and 12-month Western Ontario and McMaster Universities Arthritis Index and International Knee Documentation Committee scores, there were no significant differences in outcomes. CONCLUSION The results of this study demonstrated that qualitative conclusions and outcome scores were found to not be associated with industry affiliation. Although the results of this study suggest that there is no influence of industry involvement on RCTs examining PRP, it is still necessary to carefully evaluate pertinent commercial affiliations when reviewing recommendations from studies before adopting new treatment approaches, such as the use of PRP for knee osteoarthritis.
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3.
A Phase 2 Randomized Controlled Trial of Single-Agent Hydroxyurea Versus Thalidomide Among Adult Transfusion Dependent β Thalassemia Patients
Bhattacharjee U, Khadwal A, Shafiq N, Lad D, Sharma P, Das R, Shukla P, Jain A, Prakash G, Malhotra P
Indian journal of hematology & blood transfusion : an official journal of Indian Society of Hematology and Blood Transfusion. 2023;:1-10
Abstract
Hydroxyurea and low dose thalidomide are low-cost, easily accessible Hb F inducing agents that have been found to decrease transfusion dependency among transfusion-dependent thalassemia patients. However, these drugs have not much been explored in a randomized controlled setting. The objective of this study was to determine the efficacy and safety of hydroxyurea and low dose thalidomide in adult transfusion dependent β thalassemia. A total of 39 transfusion dependent β thalassemia patients were randomized into three arms: Arm A (Hydroxyurea 500 mg/day), Arm B (thalidomide 50 mg/day), and Control Arm. The primary outcome was rise in haemoglobin at 24-weeks from the baseline levels. The mean age of the cohort was 26.9 ± 4.7 years. Total 13 patients (33.3%) were splenectomised. The mean rise of haemoglobin at the end of 24 weeks was 0.18 ± 0.645 g/dl, 0.56 ± 1.343 g/dl, and - 0.31 ± 0.942 g/dl in Arm A, Arm B and control arm, respectively, p = 0.127. The mean volume of blood transfused per unit body weight in 24 weeks was significantly less in the thalidomide arm compared with the control arm (p = 0.035). Abdominal pain (Grade 1-2, 23.1%) and pruritus (Grade 1, 15.4%) were the main adverse events in hydroxyurea arm, whereas somnolence was the main side effect noted in the thalidomide arm (Grade 1-2, 78.3%). Single agent hydroxyurea or thalidomide is ineffective in increasing haemoglobin and decreasing transfusion burden among majority of the adult transfusion dependent thalassemia patients. SUPPLEMENTARY INFORMATION The online version contains supplementary material available at 10.1007/s12288-022-01620-3.
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4.
The Optimal Hemostasis Duration After Tooth Extraction: A Randomized Controlled Trial
Yerragudi N, Chawla JG, Kalidoss VK, Polineni S, Jayam C, Kumar C
Cureus. 2023;15(1):e33331
Abstract
Background There is a lack of evidence-based practice regarding the duration of pressure pack placement following tooth extraction. This study aimed to compare the incidence of post-extraction bleeding following 60 minutes versus 10 minutes of pressure pack placement. Methodology A randomized controlled trial was conducted at a tertiary care hospital and included patients requiring intra-alveolar tooth extractions. Patients were randomly allocated into the experimental group or control group by a permuted block randomization method. A blinded observer noted the incidence of post-extraction bleeding. Categorical variables were summarized as frequency and percentage. The chi-square test was used for intergroup statistical analysis. P-values <0.05 were considered statistically significant. Results There were 528 participants, 264 of whom were allocated to each group. The incidence of post-extraction bleeding was 8% and 6.8% in the experimental and control groups, respectively. On bivariate analysis, there was no statistically significant difference between the two groups (p = 0.618; relative risk with 95% confidence interval = 1.0). Conclusions In the majority of cases, hemostasis was achieved in 10 minutes. Therefore, removing the pressure pack after 10 minutes may be advised to ensure hemostasis and, ultimately, save chairside time.
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5.
The efficacy of non-surgical platelet-rich fibrin application on clinical periodontal parameters and periostin level in periodontitis: Clinical trial
Al-Rihaymee S, Sh Mahmood M
Journal of cellular and molecular medicine. 2023
Abstract
Platelet-rich fibrin (PRF) has been widely used in regenerative dentistry due to many growth factors produced. Periostin, a matricellular protein, is a reliable marker for tissue regeneration. Periostin is part of the cellular matrix and regulates bone homeostasis. This study aims to explore the efficacy of PRF in improvement of the clinical periodontal parameters as an adjunct to the scaling and root planing and to evaluate periostin level in gingival crevicular fluid (GCF) at baseline, 1- and 3-month recall visits. Fourteen periodontitis patients who met the inclusion criteria were recruited in this study. Two contralateral periodontal pockets with 4-6 mm in depth in each patient were selected. The sites in every participant were randomly allocated into control sites or test sites. In control sites, only conventional scaling and root planing was carried out. In test sites, however, scaling and root planing method and PRF were applied. Periostin level in GCF and clinical periodontal parameters were measured. The test sites revealed greater relative attachment gain (2.614 ± 0.606 mm and 3.321 ± 0.668 mm) than control sites (1.285 ± 0.671 mm and 1.839 ± 0.632 mm) and a significant pocket reduction (2.535 ± 0.664 mm and 3.321 ± 0.668 mm) than the control sites (1.21 ± 0.508 mm and 1.892 ± 0.655 mm) at 1- and 3-month recall visits respectively. In the test sites, level of periostin (48.83 ± 9.3 ng/μl and 98.90 ± 24.94 ng/μl) were greater than periostin levels in the control sites (42.65 ± 7.03 ng/μl and 49.29 ± 15.14 ng/μl) at 1- and 3-month recall visits respectively. In conclusion, the non-surgical application of PRF as an adjunct to scaling and root planing significantly improved the clinical periodontal parameters through raising periostin level in GCF.
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6.
The ICaRAS randomised controlled trial: Intravenous iron to treat anaemia in people with advanced cancer - feasibility of recruitment, intervention and delivery
Dickson EA, Ng O, Keeler BD, Wilcock A, Brookes MJ, Acheson AG
Palliative medicine. 2023;:2692163221145604
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Editor's Choice
Abstract
BACKGROUND Anaemia is highly prevalent in people with advanced, palliative cancer yet sufficiently effective and safe treatments are lacking. Oral iron is poorly tolerated, and blood transfusion offers only transient benefits. Intravenous iron has shown promise as an effective treatment for anaemia but its use for people with advanced, palliative cancer lacks evidence. AIMS To assess feasibility of the trial design according to screening, recruitment, and attrition rates. To evaluate the efficacy of intravenous iron to treat anaemia in people with solid tumours, receiving palliative care. DESIGN A multicentre, randomised, double blind, placebo-controlled trial of intravenous iron (ferric derisomaltose, Monofer(®)). Outcomes included trial feasibility, change in blood indices, and change in quality of life via three validated questionnaires (EQ5D5L, QLQC30, and the FACIT-F) over 8 weeks. (ISRCTN; 13370767). SETTING/PARTICIPANTS People with anaemia and advanced solid tumours who were fatigued with a performance status ⩽2 receiving support from a specialist palliative care service. RESULTS 34 participants were randomised over 16 months (17 iron, 17 placebo). Among those eligible 47% of people agreed to participate and total study attrition was 26%. Blinding was successful in all participants. There were no serious adverse reactions. Results indicated that intravenous iron may be efficacious at improving participant haemoglobin, iron stores and select fatigue specific quality of life measures compared to placebo. CONCLUSION The trial was feasible according to recruitment and attrition rates. Intravenous iron increased haemoglobin and may improve fatigue specific quality of life measures compared to placebo. A definitive trial is required for confirmation.
PICO Summary
Population
People with anaemia and advanced solid tumours, enrolled in the Intravenous Iron for Cancer Related Anaemia Symptoms (ICaRAS) trial (n= 34).
Intervention
Intravenous iron (n= 17).
Comparison
Placebo: sodium chloride (n= 17).
Outcome
Outcomes included trial feasibility, change in blood indices, and change in quality of life via three validated questionnaires over 8 weeks. Among those eligible, 47% of people agreed to participate and total study attrition was 26%. Blinding was successful in all participants. There were no serious adverse reactions. Compared to baseline, there was a significant rise in haemoglobin, ferritin, and transferrin saturation % at weeks 4 and 8 for participants in the iron group but not the placebo group. Anaemia resolution was achieved in 39% of intravenous iron participants by week 8 compared to 8% of the placebo group.
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The Effectiveness of Student-Led Ward Round Training on Knowledge Acquisition, Critical Thinking Ability, and Self-Confidence of Acute Upper Gastrointestinal Bleeding for Nursing Students
Liu N, Zheng Z, Liao J, Li J, Yang Z, Lai X
Advances in medical education and practice. 2023;14:21-30
Abstract
INTRODUCTION Nursing knowledge, critical thinking ability, and self-perceived confidence are imperative to nursing skills in professional nursing practice. Therefore, nurse educators are required to use teaching strategies that will help promote their knowledge, critical thinking, and self-confidence in complex contents such as the nursing of acute upper gastrointestinal bleeding (AUGIB). PURPOSE This study compares the effect of student-led and instructor-led ward-round training methods on knowledge acquisition, critical thinking ability, and self-perceived confidence during AUGIB sessions. METHODS Forty nursing students in the first year of the Emergency Nursing Residency Program were randomly divided into a student-led ward round training group (SG) and an instructor-led ward round training group (IG) with a ratio of 1:1. A knowledge quiz, critical thinking ability test, and self-perceived confidence questionnaire were performed before and after the ward round training to assess both groups of students for their knowledge acquisition, critical thinking ability, and self-perceived confidence improvement. Feedback questionnaires were conducted after the training to evaluate students' perspectives and interests concerning the teaching module. RESULTS The scores of the post-training quiz were significantly higher than that of the pre-training quiz in both the SG (44.10±2.92 vs 31.10±4.27, p<0.001) and IG (32.35±2.21 vs 30.55±2.24, p=0.01). In the post-training quiz, scores achieved by the students from the SG (44.10±2.92) were significantly higher than those achieved by the students from the IG (32.35±2.21, p< 0.001). The level of self-perceived confidence improved significantly after ward round training in the SG (p< 0.001). However, there was no statistically significant difference in the IG with respect to the change from pre- to post-training (p=0.43).The students' critical thinking ability improved significantly in the SG (14.95±2.58 vs 7.10±1.79, p<0.001), while no significant improvement was found in the IG (7.91±2.28 vs 6.52±2.21, p=0.07) after ward round training. CONCLUSION The teaching method of SWRT improves nursing students' knowledge acquisition, critical thinking ability, and self-perceived confidence in AUGIB.
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Efficacy of COVID convalescent plasma therapy in hospitalized moderate coronavirus disease 2019 patients
Irawan C, Rumende CM, Sukrisman L, Pitoyo CW, Suwarto S, Susilo A, Mulansari NA, Harahap AT, Priantono D, Syafitri R, et al
Journal of infection in developing countries. 2023;17(1):43-51
Abstract
INTRODUCTION Covid Convalescent Plasma (CCP) failed to demonstrate its efficacy in severe and life-threatening coronavirus disease 2019 (COVID-19) cases. However, the role of CCP in hospitalized moderate cases is unclear. This study aims to examine the efficacy of administering CCP to hospitalized moderate coronavirus disease 2019 patients. METHODOLOGY An open-label randomized controlled clinical trial design was used from November 2020 - August 2021 at two referral hospitals in Jakarta, Indonesia, and the primary outcome was mortality at 14 days. The secondary outcomes were mortality at 28 days, the time-to-discontinuation of supplemental oxygen, and the time-to-hospital discharge. RESULTS This study recruited 44 subjects, and the intervention arm consisted of 21 respondents who received CCP. The control arm consisted of 23 subjects who received standard-of-care treatment. All subjects survived during the fourteen-day follow-up period, and the 28-day mortality rate in the intervention group was lower than the control (4.8% vs 13.0%; p = 0.16, HR = 4.39 (95% CI = 0.45-42.71). There was no statistically significant difference in the time-to-discontinuation of supplemental oxygen and time-to-hospital discharge. During the total follow-up period (41 days), the mortality rate in the intervention group was also lower than the control (4.8% vs 17.4%, p = 0.13, HR = 5.47, 95% CI = 0.60-49.55). CONCLUSIONS This study concluded that in hospitalized moderate COVID-19 patients, CCP did not reduce 14-day mortality compared to the control. Mortality during 28 days and total length of stay (41 days) were lower in the CCP group compared to the control, although they did not reach statistical significance.
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9.
Comparative study between platelet-rich plasma (PRP) and mechanically emulsified fat grafts in management of chronic wounds
Nagy Mohamed E, Elsherbeny KM, Elshahat A, Setta HS
Asian journal of surgery. 2023
Abstract
BACKGROUND chronic wounds represent a challenge in treatment, due to diverse pathogenesis, resistance to ordinary treatment complex and lack of direct methods of treatment In this study, the aim is to compare the effect of Platelet -rich plasma (PRP) and mechanically emulsified fat grafts on the outcome of the healing process of chronic wounds. PATIENTS AND METHODS In the current study, 30 patients with chronic wounds were divided into two groups (Group I, 15 patients had application of PRP on chronic wounds). Whereas (Group II, 15 patients had application of mechanically emulsified fat on chronic wounds). In both groups assessment of the healing rates and histopathological changes that were determined by observing the parameters of wound healing, including peri-lesional skin quality, observation of the wound size and depth, assessment of the pain indicated by Visual analog scale score. RESULTS Patient were followed up for 6 months. Group II showed a better healing rate 64% in comparison to Group I 55%. Wound parameters and pain score were recorded in both groups with no statistically significant difference. CONCLUSION Both PRP and mechanically emulsified fat grafts were found to be efficient treatment modalities in management of chronic "non-healing" wounds. But mechanically emulsified fat grafts represent a better treatment method for chronic wounds.
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10.
Dorsal Wrist Ganglion: Pilot for Randomized Control Trial Comparing Aspiration Alone or Combined with Injection of Platelet-Rich Plasma
Hamlin K, Haddon A, Khan Y, Miller C, Lawrie D
Journal of wrist surgery. 2023;12(1):18-22
Abstract
This pilot study assessed the feasibility of performing a randomized control trial (RCT) investigating injection with platelet-rich plasma (PRP) for dorsal wrist ganglion (DWG). Aspiration alone was compared with aspiration plus injection of PRP. Seventeen patients were enrolled. Nine patients received PRP and eight aspiration alone. Patients were followed up at 6 weeks and 1 year; recurrence of the ganglion and Patient Evaluation Measure scores were measured. At 6 weeks seven patients in the aspiration group had a recurrence and five in the PRP group, but by 1 year, this has increased to seven out of eight in the PRP group whereas in the aspiration group four had resolved leaving three out of eight patients with a ganglion still present. From the basis of our work an RCT would require a minimum of 46 patients per group; however, it is unlikely that PRP will be a panacea for ganglia. This is a Level II study.
