Single-centre Randomised Controlled Trial Research Articles

The Role of Tranexamic Acid (TXA) In Spine Surgery for Patients with Comorbidities in Basra/Iraq

Background: Blood loss occurs frequently and remains a challenge in spinal surgery. As significant intra and postoperative hemorrhage negatively affects patient outcomes by increasing coagulopathy, postoperative hematoma, and anemia. The need for allogenic blood transfusions can lead to potential transfusion reactions and infections, in addition to increasing long-term mortality rates. Although there are many randomized control trials and meta-analysis investigating the role of tranexamic acid (TXA), we could not find any study that investigated the role of TXA in patients with medical comorbidities. Therefore, tackling the role of TXA in patients with single or multiple comorbidities is of valuable outcome to our locality as most of the patients have indeed associated comorbidities. Objectives: to investigate the role of tranexamic acid in decreasing perioperative blood loss in patients with multiple comorbidities as compared to otherwise healthy individuals. Patients and methods: A single center randomized control trial. We included patients that were about to undergo simple decompressive surgeries for lumbar canal stenosis and fixation with decompression for spondylolisthesis. Patients were randomly categorized into cases (who received TXA) and controls who received NS. Patients then were subcategorized according to comorbidities and types of surgeries. Intraoperative blood loss was calculated using the suction drain and the gauze while the post operative bleeding was calculated using the drain output. Results: There was 441.84 ml (49.6 %) decrease in intraoperative bleeding for patients who received TXA as compared to controls regardless the type of surgery and regardless the presence or absence of comorbidities. Hypertensive patients had 52.7 % reduction in intraoperative bleeding when received TXA, Diabetic patients showed 44.4 % reduction in bleeding, Obese patients showed 51.1% reduction and patients with multiple comorbidities showed 51% reduction in intraoperative bleeding while healthy individuals showed 38.9% reduction in intraoperative bleeding. Conclusion: TXA was even more effective in decreasing intraoperative bleeding in patients with multiple comorbidities as compared to healthy individuals.

The effectiveness of pharmacist-led educational model in adult patients with allergic rhinitis: a single-center randomized control trial protocol (AR-PRISE RCT)

BackgroundAllergic rhinitis is a chronic respiratory disorder that significantly impacts patients’ quality of life (QoL) and work performance. Pharmacists are recognized as suitable professionals to provide patient education and pharmaceutical care for managing allergic rhinitis patients. However, local clinical practice guidelines, particularly regarding pharmaceutical care in public healthcare institutions, are lacking. This study protocol outlines a randomized controlled trial (RCT) designed to evaluate the effectiveness of a pharmacist-led educational model (AR-PRISE Model) in managing allergic rhinitis in adult patients compared to standard pharmaceutical care. The AR-PRISE model delivers patient educational material and a pharmaceutical care algorithm.MethodThis is a 6-month, single-center, prospective, randomized, two-arm, and parallel-group controlled trial. The trial recruits patients attending the otorhinolaryngology clinics of a tertiary referral hospital. Participants are randomized into control or intervention groups in a 1:1 ratio using permuted block randomization. The total number of participants estimated is 154, with each group requiring 77 participants. The control group receives standard pharmaceutical care, while the intervention group receives pharmacist-led education according to the AR-PRISE model. Both groups are assessed for middle turbinate endoscopy findings, disease severity, knowledge level, symptom control, medication adherence, and QoL at baseline and the end-of-study follow-up (day 180 ± 7). Depending on feasibility, intermediate follow-ups are conducted on days 60 ± 7 and 120 ± 7, either virtually or face-to-face. During intermediate follow-ups, participants are assessed for symptom control, medication adherence, and QoL. The intention-to-treat analysis includes all participants assigned to each group. An independent T-test compares the mean difference in knowledge level between the two groups. A two-way repeated measures ANOVA analysis is employed to determine between-group differences for scores of symptom control, adherence rate, and QoL. A P-value < 0.05 is considered statistically significant.DiscussionThis study protocol will provide a framework for conducting a randomized controlled trial (RCT) to evaluate the effectiveness of pharmacist-led education intervention in managing allergic rhinitis within public healthcare settings. The parameters measured in this trial will quantify outcomes associated with improvements in symptoms and QoL. By systematically assessing these outcomes, we aim to contribute valuable insights into the role of pharmacist-led interventions in enhancing the management of allergic rhinitis in public healthcare settings.Trial registrationClinicalTrials.gov NCT06027736. Registered on 9 July 2023—retrospectively registered.

Enhanced recovery protocols after surgery: A systematic review and meta-analysis of randomized trials in cardiac surgery.

Previous meta-analyses combining randomized and observational evidence in cardiac surgery have shown positive impact of enhanced recovery protocols after surgery (ERAS) on postoperative outcomes. However, definitive data based on randomized studies are missing, and the entirety of the ERAS measures and pathway, as recently systematized in guidelines and consensus statements, have not been captured in the published studies. The available literature actually focuses on "ERAS-like" protocols or only limited number of ERAS measures. This study aims at analyzing all randomized studies applying ERAS-like protocols in cardiac surgery for perioperative outcomes. A meta-analysis of randomized controlled trials (RCTs) comparing ERAS-like with standard protocols of perioperative care was performed (PROSPERO registration CRD42021283765). PRISMA guidelines were used for abstracting and assessing data. Thirteen single center RCTs (N=1704, 850 in ERAS-like protocol and 854 in the standard care group) were selected. The most common procedures were surgical revascularization (66.3%) and valvular surgery (24.9%). No difference was found in the incidence of inhospital mortality between the ERAS and standard treatment group (risk ratio [RR] 0.61 [0.31; 1.20], p=0.15). ERAS was associated with reduced intensive care unit (standardized mean difference [SMD] -0.57, p<0.01) and hospital stay (SMD -0.23, p<0.01) and reduced rates of overall complications when compared to the standard protocol (RR 0.60, p<0.01) driven by the reduction in stroke (RR 0.29 [0.13; 0.62], p<0.01). A significant heterogeneity in terms of the elements of the ERAS protocol included in the studies was observed. ERAS-like protocols have no impact on short-term survival after cardiac surgery but allows for a faster hospital discharge while potentially reducing surgical complications. However, this study highlights a significant nonadherence and heterogeneity to the entirety of ERAS protocols warranting further RCTs in this field including a greater number of elements of the framework.

Is basal cisternostomy in traumatic brain injury a need of hour or white elephant - A randomized trial to answer.

Basal cisternostomy (BC) recently emerged as an adjuvant/alternative procedure to decompressive craniectomy (DC) in traumatic brain injuries (TBIs) with its potential to effectively reduce both intracranial pressure (ICP) and brain edema. However, its role in TBI is not yet established in the true sense and with clarity. The objective of the present study was to evaluate the effect of adjuvant BC on ICP, mortality, and clinicoradiological outcome. A single-center randomized control trial was conducted. Fifty patients were assigned to each DC-group and DC+BC-group. Randomization was done using the sealed envelope method. Both groups were followed in the postoperative period to compare the impact of surgery on ICP, radiological changes, and clinical outcome (mortality, days on ventilator/in intensive care unit (ICU), and Glasgow outcome scale-extended (GOS-E) at 12 weeks). Both groups were comparable in terms of preoperative clinicoradiological characteristics. On postoperative days 1, 2, and 3, mean ICP was significantly low in the DC+BC-group (P < 0.0001). The decline in ICP in the DC+BC-group was significant in both moderate and severe TBI patients. In comparison, DC+BC-group has a shorter duration of mechanical ventilation/ICU stay and significantly better GOS-E score at 12 weeks (P < 0.0001*). The mortality rate was less in the DC+BC-group (48%) as compared to the DC-group (64%). Among radiological features, mean midline shift and mean outward brain herniation were significantly less in the DC+BC group. Bone-flap replacement was possible in ten patients of DC+BC-group at the time of primary surgery. Results of our study indicated that BC is beneficial in reducing both ICP and brain edema, which translates into favorable clinicoradiological outcomes.

Pars plana vitrectomy with internal limiting membrane flap versus pars plana vitrectomy with conventional internal limiting membrane peeling for large macular hole.

Macular hole (MH) is a full-thickness defect in the central portion of the retina that causes loss of central vision. According to the usual definition, a large MH has a diameter greater than 400 µm at the narrowest point. For closure of MH, there is evidence that pars plana vitrectomy (PPV) with internal limiting membrane (ILM) peeling achieves better anatomical outcomes than standard PPV. PPV with ILM peeling is currently the standard of care for MH management; however, the failure rate of this technique is higher for large MHs than for smaller MHs. Some studies have shown that the inverted ILM flap technique is superior to conventional ILM peeling for the management of large MHs. To evaluate the clinical effectiveness and safety of pars plana vitrectomy with the inverted internal limiting membrane flap technique versus pars plana vitrectomy with conventional internal limiting membrane peeling for treating large macular holes, including idiopathic, traumatic, and myopic macular holes. The Cochrane Eyes and Vision Information Specialist searched CENTRAL, MEDLINE, Embase, two other databases, and two trials registries on 12 December 2022. We included randomized controlled trials (RCTs) that evaluated PPV with ILM peeling versus PPV with inverted ILM flap for treatment of large MHs (with a basal diameter greater than 400 µm at the narrowest point measured by optical coherence tomography) of any type (idiopathic, traumatic, or myopic). We used standard methodological procedures expected by Cochrane and assessed the certainty of the body of evidence using GRADE. We included four RCTs (285 eyes of 275 participants; range per study 24 to 91 eyes). Most participants were women (63%), and of older age (range of means 59.4 to 66 years). Three RCTs were single-center trials, and the same surgeon performed all surgeries in two RCTs (the third single-center RCT did not report the number of surgeons). One RCT was a multicenter trial (three sites), and four surgeons performed all surgeries. Two RCTs took place in India, one in Poland, and one in Mexico. Maximum follow-up ranged from three months (2 RCTs) to 12 months (1 RCT). No RCTs reported conflicts of interest or disclosed financial support. All four RCTs enrolled people with large idiopathic MHs and compared conventional PPV with ILM peeling versus PPV with inverted ILM flap techniques. Variations in technique across the four RCTs were minimal. There was some heterogeneity in interventions: in two RCTs, all participants underwent combined cataract-PPV surgery, whereas in one RCT, some participants underwent cataract surgery after PPV (the fourth RCT did not mention cataract surgery). The critical outcomes for this review were mean best-corrected visual acuity (BCVA) and MH closure rates. All four RCTs provided data for meta-analyses of both critical outcomes. We assessed the risk of bias for both outcomes using the Cochrane risk of bias tool (RoB 2); there were some concerns for risk of bias associated with lack of masking of outcome assessors and selective reporting of outcomes in all RCTs. All RCTs reported postoperative BCVA values; only one RCT reported the change in BCVA from baseline. Based on evidence from the four RCTs, it is unclear if the inverted ILM flap technique compared with ILM peeling reduces (improves) postoperative BCVA measured on a logarithm of the minimum angle of resolution (logMAR) chart at one month (mean difference [MD] -0.08 logMAR, 95% confidence interval [CI] -0.20 to 0.05; P = 0.23, I2 = 65%; 4 studies, 254 eyes; very low-certainty evidence), but it may improve BCVA at three months or more (MD -0.17 logMAR, 95% CI -0.23 to -0.10; P < 0.001, I2 = 0%; 4 studies, 276 eyes; low-certainty evidence). PPV with an inverted ILM flap compared to PPV with ILM peeling probably increases the proportion of eyes achieving MH closure (risk ratio [RR] 1.10, 95% CI 1.02 to 1.18; P = 0.01, I2 = 0%; 4 studies, 276 eyes; moderate-certainty evidence) and type 1 MH closure (RR 1.31, 95% CI 1.03 to 1.66; P = 0.03, I² = 69%; 4 studies, 276 eyes; moderate-certainty evidence). One study reported that none of the 38 participants experienced postoperative retinal detachment. We found low-certainty evidence from four small RCTs that PPV with the inverted ILM flap technique is superior to PPV with ILM peeling with respect to BCVA gains at three or more months after surgery. We also found moderate-certainty evidence that the inverted ILM flap technique achieves more overall and type 1 MH closures. There is a need for high-quality multicenter RCTs to ascertain whether the inverted ILM flap technique is superior to ILM peeling with regard to anatomical and functional outcomes. Investigators should use the standard logMAR charts when measuring BCVA to facilitate comparison across trials.

The effect of touch on pain, anxiety, and the patient experience during bone marrow biopsies.

e24131 Background: Many patients report severe pain and anxiety during bone marrow biopsies (BMBx), but there is no formal consensus on the best approach to managing these symptoms during the procedure. The aims of this study were to evaluate the effect of simple foot touch on pain and anxiety during BMBx, and to describe the patients’ experience during the procedure. Methods: A single-center randomized control trial using permuted block randomization was conducted at a rural academic cancer center. Nursing assistants without specialized massage training performed simple foot touch on patients in the intervention arm, while the BMBx was performed by advanced practice registered nurses. The patients in the control arm received usual care. Patients rated pain and anxiety levels before and after BMBx using the Visual Analog Scale (VAS) and Spielberger State-Trait Anxiety Inventory (STAI) scales, respectively. All participants completed a post-intervention survey about their experience. Results: 46 patients were enrolled in the study; 21 in the intervention arm (median age 64.1 years) and 25 in the control arm (median age 64.4 years). There was no difference in the use of anxiolytics (p = 0.51) or opioids (p = 0.48) during the procedure between the two arms. There were no statistically significant differences on the VAS (p = 0.37) or STAI (p = 0.40) between the intervention and control arms. Participants in the intervention arm reported more positive feedback and had fewer suggestions for improving the patient experience compared to the control arm (table 1). Conclusions: This is the first study to use an interprofessional team approach to evaluate the impact of touch on pain, anxiety, and the patient experience during BMBx. While the intervention did not impact pain or anxiety scores, it may be a feasible, minimal-risk, and no-cost intervention to improve patients’ overall experience during BMBx. Clinical trial information: NCT04935775 . [Table: see text]

Digital technology for early identification of exacerbations in people with cystic fibrosis.

Cystic fibrosis (CF) is a life-limiting genetic condition affecting various organ systems including the gastrointestinal tract, endocrine system and especially the respiratory tract. Pulmonary exacerbations in CF result in increased symptoms, an acceleration in the rate of lung decline and an increased need for treatment. Early detection of infections or clinical worsening provides an opportunity for proactive treatment that may affect clinical outcomes. To evaluate whether digital technology can effectively predict pulmonary exacerbations to allow earlier intervention and improved health outcomes without increasing the burden of treatment in people with CF. We used standard, extensive Cochrane search methods. We searched the Cochrane Cystic Fibrosis Trials Register and the reference lists of relevant articles and reviews on 13 October 2022. We searched Embase and the clinical trial registries on 3 January 2023. We included randomised controlled trials (RCTs) or quasi-RCTs in people with CF looking at whether digital technology can effectively predict pulmonary exacerbations to allow earlier intervention and improved health outcomes without increasing the burden of treatment. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were 1. pulmonary exacerbations and 2. quality of life (QoL). Our secondary outcomes were 3. lung function, 4. hospitalisations, 5. intravenous (IV) antibiotics, 6. microbiology, 7. cost-effectiveness and 8. We used GRADE to assess certainty of evidence. We included three studies (415 participants) in people with CF aged 15 to 41 years over a 12-month period. One was a multicentre RCT, whilst two were single-centre RCTs. The three studies were mostly similar in their risk of bias, having low or unclear risk of selection bias but a high risk of detection bias, due to the unblinded design of these studies. The studies used a variety of digital technologies to monitor symptoms such as a digital symptom diary either with or without home spirometry monitoring. As the trials only included adults and older children, we are not certain that the results would apply to younger children. One of our primary outcomes was to assess time to detection of pulmonary exacerbation and number of pulmonary exacerbations identified between the intervention and routine care groups. We were largely unable to pool results in a meta-analysis due to the variety of methodologies and ways of reporting data. Two studies noted a shorter time to detection of exacerbations in the intervention group and one of these also reported that the intervention group had a shorter time to first exacerbation (hazard ratio for time to first exacerbation 1.45, 95% confidence interval (CI) 1.09 to 1.93), whilst a further study reported a shorter time to detection of exacerbations in the intervention group requiring oral or IV antibiotics compared to the control group (median: 70 (interquartile range (IQR) 123) days with intervention versus 141 (IQR 140) days with control; P = 0.02). However, all three studies were concordant in finding no probable effect on spirometry in the intervention groups when compared with their routine care groups over a 12-month period. We found that there is probably no difference between groups with regard to QoL scores across most domains except for Weight and Body Image, which favoured the usual care group. There is also probably no difference in the number of days of additional IV antibiotics needed or newly detected pathogens. No studies reported serious adverse events directly linked to the intervention and one study reported their smartphone application was generally well received. Pulmonary exacerbations are universally accepted to be detrimental to progression of CF-related lung disease, therefore, it is intuitive that early detection and intervention would help to improve outcomes. Digital technology provides an opportunity to detect physiological and symptomatic changes to identify exacerbations early. Our review found that digital technologies based on recording physiological change (spirometry) and symptoms probably allow earlier identification of exacerbations as a group. However, this may not reduce the number of exacerbations warranting IV antibiotics and there is probably no effect on lung function. This may be partly due to inconsistent definitions of pulmonary exacerbations and discrepancy in the management strategies for pulmonary exacerbations. Overall, the intervention may make little or no difference to QoL scores. The adherence to and uptake of digital technologies, especially those which include physiological measurements, are not well sustained and the costs of these need to be balanced against the clinical efficacy.

A Comparison of Tissue Adhesive Material and Suture as Wound-Closure Techniques following Carpal Tunnel Decompression: A Single-Center Randomized Control Trial.

Carpal tunnel syndrome (CTS) is the most common peripheral neuropathy caused by compression of the median nerve in the carpal tunnel. The presented study aimed to evaluate clinical outcomes by comparing two techniques of wound closure following carpal tunnel surgery in subjects randomized to the application of tissue adhesive or sutures. From April 2022 to December 2022, a single-center randomized prospective trial was conducted at the University Hospital of Split in Croatia. The study participants consisted of 100 patients (70 females) aged 61.56 ± 12.03 years, randomly assigned to suture-based wound closure (n = 50) or tissue adhesive-based wound closure (n = 50) with two-component skin adhesive Glubran Tiss 2®. The outcomes were assessed postoperatively during the follow-up period at intervals of 2, 6, and 12 weeks. A scar assessment was performed using the POSAS (Patient and Observer Scar Assessment Scale) and cosmetic VAS (Visual Analog Scale). The VNRS (Verbal Number Rating Scale) was used to assess pain. There were significant differences between glue-based wound closure and suture-based wound closure at 2-week and 6-week intervals after the surgery on the POSAS and cosmetic-VAS scales (better aesthetic effect with glue-based wound closure technique where noticed), with less postoperative pain at the same intervals. With the 12-week interval, differences in outcomes were insignificant. This trial demonstrated that cyanoacrylate-based adhesion mixtures might be possibly superior in the short term in terms of cosmetic appearance and discomfort compared to conventional skin suturing techniques for the closing of surgical wounds following open CTS decompression, but there was no difference between both procedures in the long term.

POSTOPERATIVE USE OF GAME READYTM CRYOCOMPRESSION SYSTEM FOLLOWING TOTAL KNEE ARTHROPLASTY: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL

Cryocompression therapy is a non-invasive and non-pharmacological modality used in managing acute post-operative inflammation and pain. A prospective, randomised controlled trial (RCT) was undertaken to evaluate the effectiveness of a post-operative cryocompression protocol using the Game ReadyTM (GR) device versus usual care on recovery following total knee arthroplasty (TKA).A single centre RCT was conducted with 70 TKAs (68 patients) randomised to a 2-week intervention period consisting of treatment with GR cryocompression (n=33, 33.3% males) or a usual care protocol of ice with static compression using tubigrip (n=35, 54.3% males). Knee range of movement (ROM) (flexion and extension), a visual analogue pain score (VAS) and limb circumference were documented at day 1, 2 and 14, as well as 6 and 12 weeks post-surgery. ROM was also recorded at day 90, while medication use and length of hospital stay were documented. Patient reported outcome measures (PROMs) including the KOOS and patient satisfaction questionnaire were employed.The GR group demonstrated 2.3° more (p=0.05) knee extension ROM overall, as well as 2. 8° more at day 1 (p=0.048), 3.8° at day 14 (p=0.007) and 5.4° at 3 months (p=0.017). There were no group differences (p&gt;0.05) observed in pain (VAS), flexion ROM, limb circumference, opioid use or other PROMs. Across the full cohort, higher pain levels resulted in increased opioid intake (p=0.002), older patients used significantly less opioids (p&lt;0.001) and males reported significantly less pain (VAS) than females (p=0.048).Using GR following TKA is a safe, non-invasive tool that can be used to aid in the post-operative recovery period.Patients using the GR cryocompression device gained significantly more extension ROM compared to the conventional ice with compression group, despite no other group differences.

The effect of 12 weeks of combined training on hepatic fat content and metabolic flexibility of individuals with non-alcoholic fatty liver disease: Protocol of an open-label, single-center randomized control trial.

Metabolic flexibility (MetF) is the capacity of an organism to oxidate substrate according to substrate availability or demand. The mismatch of substrate availability and oxidation may cause ectopic fat accumulation in the muscle and the liver. The objectives of the study are to examine the effect of 12 weeks of combined exercise on hepatic fat reduction and investigate metabolites related to MetF before and after the high-fat diet between individuals with NAFLD and healthy control with an active lifestyle. This study is an open-label, single-center trial randomized controlled clinical study plus a cross-sectional comparison between individuals with NAFLD and healthy control. Individuals with NAFLD were allocated into two groups receiving resistance training (RT) combined with high-intensity interval training (HIIT) or moderate-intensity continuous training (MICT). Anthropometric indicators, clinical blood markers about glucose, lipid metabolism, and hepatic fat content (HFC) were assessed before and after the intervention. The metabolomics was also used to investigate the discrepant metabolites and mechanisms related to MetF. Metabolic flexibility reflects the capacity of an organism to switch the oxidation substrates flexibly, which is associated with ectopic fat accumulation. Our study aimed to explore the discrepant metabolites related to MetF before and after a high-fat diet between individuals with NAFLD and healthy control. In addition, the study also examined the effectiveness of RT combined with HIIT or MICT on hepatic fat reduction and quantificationally analyzed the metabolites related to MetF before and after the intervention. Our results provided a perspective on fatty liver-associated metabolic inactivity. ClinicalTrials.gov: ChiCTR2200055110; Registered 31 December 2021, http://www.chictr.org.cn/index.aspx.

846: IS TRANSTRACHEAL POCUS HELPFUL IN DETERMINING ENDOTRACHEAL TUBE POSITION? A RANDOMIZED CONTROL TRIAL

Introduction: Endotracheal tube (ETT) malposition is associated with adverse events. Chest x-ray (CXR) is the gold standard modality for determining ETT position and depth in the trachea. However, Point-of-Care Ultrasound (POCUS) has emerged as a novel non-invasive alternative. We aimed to determine if an integrated protocol employing both transtracheal ultrasound and CXR for identifying ETT malposition in the trachea, compared to CXR alone, would result in fewer adverse events. Methods: We performed a single-center randomized control trial of intubated patients in a multidisciplinary intensive care unit at an academic hospital. Intubated patients were randomized into two arms: POCUS integrated or CXR alone daily ETT monitoring. In both arms, trained sonographers assessed for ETT position and related adverse events: migration into bronchus, herniation into vocal cords, balloon rupture, unplanned extubation, and aspiration pneumonia. In the POCUS integrated arm, the ICU rounding team was provided with the sonographer’s findings to aid in clinical decision making. A Pearson’s Chi-Squared test was used to compare the results between the two arms. Results: A total of 76 patients amounting to 187 ventilator days were randomized to receive either POCUS integrated (91 ventilator days) or CXR alone (96 ventilator days) daily ETT monitoring. The average patient age was 57.8 years +/- 17.0 years. Most patients were intubated for airway protection (46.1%) and hypoxic respiratory failure (40.8%). There were 10 adverse events recorded (7 aspiration pneumonias, 1 herniation through the vocal cords, 2 migration into a bronchus) out of 187 ventilator days. There was a trend toward lower adverse events in the POCUS integrated group compared to the CXR alone group (2.2% vs. 8.3%; p=0.062, respectively). Furthermore, the ETT depth was adjusted more frequently in the POCUS integrated group compared to the CXR alone group; however, this was not statistically significant (7.7% vs. 3.1%; p=0.165, respectively). Conclusions: Based on our data, the integrated protocol employing transtracheal ultrasound and CXR did not result in fewer adverse events than CXR alone. However, there was a trend toward less adverse events with the integrated protocol, and further investigations with larger sample sizes are needed.

Announcing the winner of the John J. Sciarra IJGO Prize Paper Award for 2021

The editors of the International Journal of Gynecology & Obstetrics (IJGO) are pleased to announce the winner of the prize paper award for the best clinical research paper from a low- or middle-income country published in IJGO during 2021. The winning paper is: Tang X, Guo C, Liu S, Guo J, Hua K and Qiu J. A novel prognostic nomogram utilizing the 2018 FIGO staging system for cervical cancer: A large multicenter study. Int J Gynecol Obstet 2021;155:86–94. https://doi.org/10.1002/ijgo.13644. It was published in the October 2021 issue of IJGO. This award brings with it a stipend of £800, a certificate of recognition, and complimentary access to IJGO for a period of 1 year from the date the prize is awarded. All clinical research articles submitted to the IJGO from low- and middle-income countries that were published in 2021 were considered for this prize. The paper was chosen from 95 qualifying articles. Selection and review were undertaken by the editors, and the Editorial Board of IJGO endorsed the decision. The winning paper by Tang et al. evaluated the prognostic performance of the revised 2018 FIGO staging system for cervical cancer in a multicentre study across four sites. In 3238 patients with cervical cancer, 1841 (almost 60%) were re-staged. Almost one third of these were re-staged due to tumor size, approximately 30% due to lymph node metastasis, and one third due to the inconsistency between the pre-operative and post-operative assessments. They concluded that the 2018 FIGO staging system was a better reflection of the survival of cervical cancer patients. This very important work also allowed the group to establish a nomogram that allowed them to predict the prognosis of cervical cancer more accurately. Additional papers that are worthy of special recognition are awarded an honorable mention. While the honorable mention recognition does not include a financial award, each author receives a certificate of recognition and a letter of commendation from the editors of IJGO. The IJGO Prize Paper Award was established in 1998 for the purpose of encouraging investigators, especially young scientists, from low- and middle-income countries to submit their best clinical research articles for publication in the journal. IJGO is the official publication of FIGO (International Federation of Gynecology and Obstetrics), the primary international organization for the specialty of obstetrics and gynecology. FIGO is dedicated to enhancing the health care of women worldwide. HONORABLE MENTIONS 2021 The following 11 papers receive an honorable mention: China Li Y, Wang H, Zhang Y, et al. Correlation between multi-type human papillomavirus infections and viral loads and the cervical pathological grade. Int J Gynecol Obstet. 2020;152:96–102. https://doi.org/10.1002/ijgo.13406 Wang X, Zhang C, Li X, Qi H, Liu Q, Lei J. Safety and efficacy of titrated oral misoprostol solution versus vaginal dinoprostone for induction of labor: a single-center randomized control trial. Int J Gynecol Obstet. 2021;154:436–443. https://doi.org/10.1002/ijgo.13546 Brazil Laporte M, Becerra A, Castro L, Veiga N Jr, Espejo-Arce X, Bahamondes L. Evaluation of clinical performance when intrauterine devices are inserted by different categories of healthcare professional. Int J Gynecol Obstet. 2021;152:196–201. https://doi.org/10.1002/ijgo.13396 Barbieri MM, Herculano TB, Dantas Silva A, Bahamondes L, Juliato CRT, Surita FG. Acceptability of ENG-releasing subdermal implants among postpartum Brazilian young women during the COVID-19 pandemic. Int J Gynecol Obstet. 2021;154:106–112. https://doi.org/10.1002/ijgo.13663 Turkey Karakas LA, Atilgan AO, Akilli H, Kuscu UE, Haberal A, Ayhan A. Nulliparity and postmenopausal status are independent factors of malignancy potential of endometrial intraepithelial neoplasia in polyps. Int J Gynecol Obstet. 2021;152:433–438. https://doi.org/10.1002/ijgo.13448 Iran Ghotbizadeh Vhdani F, Nasiri Khormoji N, Eftekhar N, et al. A double-blind randomized trial on subendometrial injection of vasopressin to control bleeding in postpartum hysterectomy due to abnormally invasive placenta. Int J Gynecol Obstet. 2021;153:228–233. https://doi.org/10.1002/ijgo.13440 South Africa Budhram S, Vannevel V, Botha T, et al. Maternal characteristics and pregnancy outcomes of hospitalized pregnant women with SARS-CoV-2 infection in South Africa: An International Network of Obstetric Survey Systems-based cohort study. Int J Gynecol Obstet. 2021;155:455–465. https://doi.org/10.1002/ijgo.13917 Goldman B, Naidoo T. Formal training in cardiotocograph interpretation of healthcare practitioners improves interpretation: a prospective descriptive analytical study in a resource constrained setting. Int J Gynecol Obstet. 2021;153:527–532. https://doi.org/10.1002/ijgo.13513 Kenya Gwako GN, Obimbo MM, Gichangi PB, Kinuthia J, Gachuno OW, Were F. Association between obstetric and medical risk factors and stillbirths in a low-income urban setting. Int J Gynecol Obstet. 2021;154:331–336. https://doi.org/10.1002/ijgo.13528 Egypt Abdallah A, Khairy M, Tawfik M, et al. Role of first-trimester three-dimensional (3D) power Doppler of placental blood flow and 3D placental volume in early prediction of pre-eclampsia. Int J Gynecol Obstet. 2021;154:466–473. https://doi.org/10.1002/ijgo.13572 Malaysia Goh YP, Tan PC, Hong JGS, Sulaiman S, Omar, SZ. Combined massage and warm compress to the perineum during active second stage of labor in nulliparas: a randomized trial. Int J Gynecol Obstet. 2021;155:532–538. https://doi.org/10.1002/ijgo.13613

Representation of Women in Atrial Fibrillation Clinical Practice Guidelines.

Atrial fibrillation (AF) is the most common arrhythmia in men and women worldwide, and its prevalence is increasing. Management of AF is guided by evidence-based clinical practice guidelines which provide recommendations based on available evidence. The extent of sex-specific data in the AF literature used to provide guideline recommendations has not been investigated. Therefore, using the 2020 Canadian Cardiovascular Society (CCS) AF management guidelines as an example, the purpose of this study was to review female representation and the reporting of sex-disaggregated data in the studies referenced in AF guidelines. Randomised controlled trials (RCTs) and prospective and retrospective cohorts were screened to calculate the proportion of study participants who were female and to establish whether studies provided sex-disaggregated analyses. The participant-prevalence ratio (PPR), a quotient of the female participant rate and the prevalence of women in the AF population, was calculated for each study. A total of 885 studies included in the CCS guidelines were considered. Of those, 467 met the inclusion criteria. Overall, women represented 39.1% of the population over all of the studies and RCTs had the lowest proportions of women (33.8%, PPR 0.70). Of studies with sex-disaggregated analyses (n= 140; 29.9%), single-centre RCTs and retrospective cohorts had the lowest and highest rates of sex-specific analyses, respectively (11.5% and 32.5%). The evidence used to derive guideline recommendations may be inadequate for sex-specific recommendations. Until enough data can support women-specific guidelines, increased inclusion of females in AF studies, may aid in the precision of recommendations.

Prospective Randomized Trial of Continuous Passive Motion Versus Physical Therapy After Arthroscopic Release of Elbow Contracture.

Continuous passive motion (CPM) has been used for decades, but we are not aware of any randomized controlled trials (RCTs) in which CPM has been compared with physical therapy (PT) for rehabilitation following release of elbow contracture. In this single-blinded, single-center RCT, we randomly assigned patients undergoing arthroscopic release of elbow contracture to a rehabilitation protocol involving either CPM or PT. The primary outcomes were the rate of recovery and the arc of elbow motion (range of motion) at 1 year. The rate of recovery was evaluated by measuring range of motion at 6 weeks and 3 months. The secondary outcomes included other range-of-motion-related outcomes, patient-reported outcome measures (PROMs), flexion strength and endurance, grip strength, and forearm circumference at multiple time points. A total of 24 patients were assigned to receive CPM, and 27 were assigned to receive PT. At 1 year, CPM was superior to PT with regard to the range of motion, with an estimated treatment difference of 9° (95% confidence interval [CI], 3° to 16°; p = 0.007). Similarly, the use of CPM led to a greater range of motion at 6 weeks and 3 months than PT. The percentage of lost motion recovered at 1 year was higher in the CPM group (51%) than in the PT group (36%) (p = 0.01). The probability of restoring a functional range of motion at 1 year was 62% higher in the CPM group than in the PT group (risk ratio for functional range of motion, 1.62; 95% CI, 1.01 to 2.61; p = 0.04). PROM scores were similar in the 2 groups at all time points, except for a difference in the American Shoulder and Elbow Surgeons (ASES) elbow function subscale, in favor of CPM, at 6 weeks. The use of CPM decreased swelling and reduced the loss of flexion strength, flexion endurance, and grip strength on day 3, with no between-group differences thereafter. Among patients undergoing arthroscopic release of elbow contracture, those who received CPM obtained a faster recovery and a greater range of motion at 1 year, with a higher chance of restoration of functional elbow motion than those who underwent routine PT. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Open Radical Cystectomy versus Robot-Assisted Radical Cystectomy with Intracorporeal Urinary Diversion: Early Outcomes of a Single-Center Randomized Controlled Trial.

Radical cystectomy (RC) with urinary diversion (UD) is still considered a complex surgery associated with significant morbidity. Open RC (ORC) remains the reference option of treatment, even if adoption of robot-assisted RC (RARC) is rapidly increasing. To date, all the available randomized controlled trials were characterized by an extracorporeal approach in performing UD, undermining potential benefits of a totally minimally invasive procedure. In this study, we aimed to report perioperative and 6-month outcomes from the first RCT comparing ORC and RARC with totally intracorporeal UD. Patients were eligible for randomization if they had a diagnostic transurethral resection of bladder tumor with cT2-4, cN0, cM0 or recurrent high-grade nonmuscle-invasive bladder cancer and no anesthesiological contraindications to robotic surgery. Patients were enrolled with a covariate adaptive randomization process based on the following variables: body mass index, American Society of Anesthesiologists® score, baseline hemoglobin, planned UD, neoadjuvant chemotherapy and cT stage. The primary end point was to demonstrate the superiority of RARC with intracorporeal UD in terms of a 50% transfusion rate reduction. Overall, 116 consecutive patients (58 RARC, 58 ORC) were enrolled. Among primary endpoint, overall perioperative transfusion rates were significantly lower in the RARC cohort (RARC: 22% vs ORC: 41%; p=0.046). This prospective randomized trial observed 22% and 41% overall perioperative transfusion rates in patients treated by RARC and ORC, respectively, confirming a significant benefit in favor of RARC with intracorporeal UD. However, perioperative complications, hospital stay and 6-month health-related quality of life were largely comparable between groups. Oncologic and functional outcomes will be assessed at longer followup to observe potential differences between arms.

Perinatal Outcomes after Fetal Endoscopic Tracheal Occlusion for Isolated Congenital Diaphragmatic Hernia: Rapid Review.

To compare the perinatal outcomes of fetuses with isolated congenital diaphragmatic hernia after fetal endoscopic tracheal occlusion (FETO) and antenatal expectant management. In this rapid review, searches were conducted in the MEDLINE, PMC, EMBASE and CENTRAL databases between August 10th and September 4th, 2020. Randomized controlled trials (RCTs), quasi-RCTs or cluster-RCTs published in English in the past ten years were included. We retrieved 203 publications; 180 studies were screened by abstract. Full-text selection was performed for eight studies, and 1 single center RCT met the inclusion criteria (41 randomized women; 20 in the FETO group, and 21 in the control group). Data collection was performed independently, by both authors, in two steps (title and abstract and full-text reading). There were no cases of maternal mortality. The mean gestational age at delivery was of 35.6 ± 2.4 weeks in the intervention group, and of 37.4 ± 1.9 weeks among the controls (p < 0.01). Survival until 6 months of age was reported in 50% of the intervention group, and in 5.8% of the controls (p < 0.01; relative risk: 10.5; 95% confidence interval [95%CI]: 1.5-74.7). Severe postnatal pulmonary hypertension was found in 50% of the infants in the intervention group, and in 85.7% of controls (p = 0.02; relative risk: 0.6; 95%CI: 0.4-0.9). An analysis of the study indicated some concerns of risk of bias. The quality of evidence was considered moderate to low. Current evidence is limited but suggests that FETO may be an effective intervention to improve perinatal outcomes.

Does the use of ultrasound guidance during percutaneous Achilles tendon tenotomy improve outcomes of clubfoot management? A randomized controlled trial.

Achilles tenotomy is a crucial aspect in the non-operative management of clubfoot as per Ponseti's casting protocol. Achilles tenotomy is routinely carried out percutaneously in a blind manner without any image guidance. This study aimed to determine the role of ultrasound-guided percutaneous Achilles tenotomy (PAT) in improving outcomes in clubfoot management. There are no previous studies that have explored the role of image guidance in PAT. This prospective, single-center randomized control trial included 50 clubfoot cases (74 feet) planned for PAT at a mean age of 30.2 months. A single experienced senior surgeon performed tenotomies. Patients were randomized to two groups, with the tenotomies performed under ultrasound guidance in one group (test group) and PAT carried out without image guidance in the other (control) group. Outcome measures assessed included rate of complications, immediate postoperative FLACC score for pain severity and Pirani score at a minimum follow-up of 12 months. There were no significant differences in the complication rates between the test and control groups regarding bleeding, nerve injury and incomplete tenotomies. The mean pain FLACC score was significantly higher in the control group (PAT without image guidance) (P = 0.03), suggesting that the child would better tolerate the ultrasound-guided procedure. All patients in both groups had a Pirani score of zero and plantigrade feet at final follow up, with no relapses. Ultrasound-guided PAT does not have any added advantage over PAT with clinical examination without image guidance in terms of long-term outcomes. Level of evidence: Therapeutic level II.

84 A Randomized Control Trial of a Multiplex Gastrointestinal PCR Panel versus Usual Testing to Assess Use of Antibiotics for Patients With Infectious Diarrhea in the Emergency Department

Infectious diarrhea is a common complaint in US emergency departments (EDs). While the most common causes of infectious diarrhea are viral, the most serious are usually due to bacterial or protozoal sources. In the ED, the provider has limited ability to evaluate for these more serious causes using traditional testing such as stool culture due to its low sensitivity and long processing time. Despite the fact that many cases of infectious diarrhea are self-limited, appropriate antibiotic therapy for most bacterial and protozoal causes of infectious diarrhea has been shown to lead to a shorter duration of symptoms and decreased spread of disease in close contacts. Multiplex gastrointestinal polymerase chain reaction (GI-PCR) panels test the stool for multiple microbiological sources and the results are available in about an hour. These tests allow the ED provider to start targeted treatment of diarrhea during the same visit thus avoiding the conundrum of empiric therapy. The objective of this study was to compare the use of a multiplex GI-PCR test to usual testing (ie, standard testing or no testing) in ED patients with suspected acute infectious diarrhea to determine if there is a change in appropriate antibiotic management. A prospective single center randomized control trial was designed to investigate antibiotic use in ED patients with moderate to severe suspected infectious diarrhea, comparing those that received GI-PCR to those that received usual testing. ED patients with signs of dehydration, inflammation or persistent symptoms were randomized to one of two treatment arms: (1) an experimental arm consisting of the multiplex GI-PCR (GIP) versus (2) a control arm which included usual testing or no testing. Mann-Whitney U test was used to compare the group differences for the continuous variables. A chi-square test or Fisher’s exact test was performed to test the group differences for categorical variables. For the purposes of our primary outcome, antibiotic usage, Farrington & Mannington score was used to calculate the confidence interval for the proportion difference between the experimental and control groups, and for each individual arm’s exact clopper-pearson confidence intervals was calculated. A total of 74 patients provided diarrheal stool samples and were randomized to either the experimental GIP arm or to the control arm consisting of usual testing. The treatment groups were well balanced with respect to characteristics at baseline. Participants in the GIP arm received antibiotics in 87% of bacterial or protozoal diarrheal infections (13/15) while those in the control arm received antibiotics in 46% of bacterial or protozoal infections (6/13) (p-value 0.042). The two-proportion difference was 0.41 with 95% CI of 00.07 and 0.68. ED use of multiplex PCR leads to an increase in antibiotic use for bacterial and protozoal causes of infectious diarrhea compared to usual testing. This increase in antibiotics appears to be appropriate given patients’ moderate to severe symptoms and a definitive identification of a likely bacterial or protozoal cause of symptoms. Results should be interpreted with caution due to the risk of side effects and antibiotic resistance associated with increased antibiotic use.

Changing knowledge, attitudes and behaviours towards cytomegalovirus in pregnancy through film-based antenatal education: a feasibility randomised controlled trial of a digital educational intervention

BackgroundCongenital cytomegalovirus (CMV) is the most common congenital infection globally, however information about CMV is not routinely included in antenatal education in the United Kingdom. This feasibility study aimed to gather the essential data needed to design and power a large randomised controlled trial (RCT) to investigate the efficacy of a digital intervention in reducing the risk of CMV acquisition in pregnancy. In order to do this, we carried out a single-centre RCT, which explored the knowledge, attitudes and risk reduction behaviours in women in the intervention and treatment as usual groups, pre- and post-intervention.MethodsCMV seronegative women living with a child less than four years old, receiving antenatal care at a single UK tertiary centre, were randomised to the digital intervention or ‘treatment as usual’ groups. Participants completed questionnaires before the digital intervention and after and at 34 gestational weeks, and responses within groups and between groups were compared using tailored randomisation tests. CMV serology was tested in the first trimester and at the end of pregnancy.ResultsOf the 878 women screened, 865 samples were analysed with 43% (n = 372) being CMV seronegative and therefore eligible to take part in the RCT; of these, 103 (27.7%) women were enrolled and 87 (84%) of these completed the study. Most participants (n = 66; 64%) were unfamiliar with CMV at enrolment, however at 34 gestational weeks, women in the intervention group (n = 51) were more knowledgeable about CMV compared to the treatment as usual group (n = 52) and reported engaging in activities that may increase the risk of CMV transmission less frequently. The digital intervention was highly acceptable to pregnant women. Overall, four participants seroconverted over the course of the study: two from each study group.ConclusionsA large multi-centre RCT investigating the efficacy of a CMV digital intervention is feasible in the United Kingdom; this study has generated essential data upon which to power such a study. This single-centre feasibility RCT demonstrates that a digital educational intervention is associated with increase in knowledge about CMV and can result in behaviour change which may reduce the risk of CMV acquisition in pregnancy.Trial registrationClinicaltrials.gov, NCT03511274, Registered 27.04.18, http://www.Clinicaltrials.gov

Airway Pressure Release Ventilation Mode Improves Circulatory and Respiratory Function in Patients After Cardiopulmonary Bypass, a Randomized Trial.

ImportancePostoperative pulmonary complications and cardiovascular complications are major causes of morbidity, mortality, and resource utilization in cardiac surgery patients.ObjectivesTo investigate the effects of airway pressure release ventilation (APRV) on respiration and hemodynamics in post cardiac surgery patients.Main Outcomes and MeasuresA single-center randomized control trial was performed. In total, 138 patients undergoing cardiopulmonary bypass were prospectively screened. Ultimately 39 patients met the inclusion criteria and were randomized into two groups: 19 patients were managed with pressure control ventilation (PCV) and 20 patients were managed with APRV. Respiratory mechanics after 4 h, hemodynamics within the first day, and Chest radiograph score (CRS) and blood gasses within the first three days were recorded and compared.ResultsA higher cardiac index (3.1 ± 0.7 vs. 2.8 ± 0.8 L⋅min–1⋅m2; p < 0.05), and shock volume index (35.4 ± 9.2 vs. 33.1 ± 9.7 ml m–2; p < 0.05) were also observed in the APRV group after 4 h as well as within the first day (p < 0.05). Compared to the PCV group, the PaO2/FiO2 was significantly higher after 4 h in patients of APRV group (340 ± 97 vs. 301 ± 82, p < 0.05) and within the first three days (p < 0.05) in the APRV group. CRS revealed less overall lung injury in the APRV group (p < 0.001). The duration of mechanical ventilation and ICU length of stay were not significantly (p = 0.248 and 0.424, respectively).Conclusions and RelevanceCompared to PCV, APRV may be associated with increased cardiac output improved oxygenation, and decreased lung injury in postoperative cardiac surgery patients.