Prospective Non-randomized Controlled Trial Research Articles

Nipple-areolar complex sensory recovery based on incision placement after nipple-sparing mastectomy: a prospective nonrandomized controlled trial.

Nipple-sparing mastectomy (NSM) aims to improve patient satisfaction by preserving the nipple-areola complex (NAC) while ensuring oncologic safety. Different surgical incisions, such as inframammary fold (IMF) and periareolar/radial incisions, are used in NSM; however, their impact on NAC sensory loss remains unclear. In this study, the authors aimed to assess NAC sensation after NSM and compare the results of different incisional approaches, specifically IMF versus periareolar/radial. In this prospective, single-center, nonrandomized controlled trial, 105 post-NSM patients were recruited from October 2019 to November 2021 and followed up at 24-48 months postsurgery. Of these, 97 (IMF: 65; periareolar/radial: 32) were analyzed for sensory assessment. NAC sensation was measured using the pin-prick test, with scores ranging from 0 (no sensation) to 2 (sharp sensation) across five NAC areas. Sensory loss was defined as a total score below 3. The median total score on the pin-prick test for NAC sensation was significantly higher in the IMF incision group than in the periareolar/radial incision group (3.77±3.11 vs. 2.47±2.51; P=0.043). The rate of NAC sensory loss was significantly lower in the IMF group than in the periareolar/radial group (36.9% vs. 62.5%; P=0.017). Multivariable analysis revealed that the incisional approach (95% CI: 0.14-0.97; P=0.044) and radiotherapy (95% CI: 0.05-0.36; P<0.01) were independent determinants of NAC sensory loss. Our study emphasized the importance of incision placement during NSM in preserving NAC sensation and may provide a valuable perspective for clinicians and patients considering this surgical approach.

Orthodontic bracket failure rate after bonding with and without primer – A systematic review and meta-analysis

To compare the difference in failure rates between orthodontic brackets bonded with light-cured primer and those bonded without primer. An electronic search of five databases and additional manual searches were performed until January 2024. Randomized and prospective non-randomized controlled trials directly comparing the bracket failure rate with and without primer. Two authors independently collected study characteristics by extracting outcome data from pre-defined sheets. After evaluating the risk of bias, the odds ratio and 95% confidence intervals (CIs) were calculated with random-effects models. Four studies were evaluated using qualitative and quantitative analysis. The analysis included data from 199 patients (1691 brackets with primer and 1646 brackets without primer). Random effects of pooled meta-analysis demonstrated statistically significant differences in the bracket failure rates (odds ratio=1.50, p=0.010, [95% CI 1.10 to 2.05]). The risk of failure was 1.5 times greater when brackets were bonded without primer. The results should be interpreted in the context of the limited sample size, even though there was a substantial difference in the failure rates of brackets with and without a primer, favouring the use of a primer. Furthermore, the validity of the finding may be limited by potential variables such as patient factors, clinician expertise, and isolation. More extensive research is required to validate these findings (PROSPERO CRD42024593134).

Implementation and outcomes of an enhanced recovery after surgery pathway for laparoscopic cholecystectomy in East and Central Africa: A prospective non-randomized controlled trial in Rwanda's Tertiary Teaching Hospital.

Enhanced recovery after surgery (ERAS) programs have demonstrated efficacy in optimizing perioperative care and improving patient outcomes in various surgeries. However, their implementation and outcomes in resource-limited settings remain underexplored. This study aimed to assess the implementation of an ERAS protocol for laparoscopic cholecystectomy in such a setting. This prospective non-randomized controlled trial involved 100 patients undergoing laparoscopic cholecystectomy at the University Teaching Hospital of Kigali, Rwanda. The first 50 patients on the ERAS pathway were prospectively evaluated and retrospectively compared to the last 50 patients operated on before ERAS implementation. Data on demographics, preoperative information, intraoperative compliance, postoperative events, and patient feedback were collected and analyzed. ERAS implementation resulted in a significant reduction in hospital length of stay (LOS) (p<0.001) without increase in complications. Compliance with ERAS principles, including preoperative education and perioperative management, was more than 90%. ERAS also reduced costs due to quicker recovery and shorter hospital LOS. The implementation of ERAS for laparoscopic cholecystectomy in a limited-resource setting is feasible and safe, suggesting the possibility of its potential adoption in other abdominal procedures. A high level of adherence to the ERAS pathway can be achieved with effective patient education and the dedication of healthcare providers.

Response-Adapted Ultralow-Dose Radiation Therapy for Orbital Indolent B-Cell Lymphoma

Radiation therapy to doses of 24 to 36 Gy is currently used to treat indolent B-cell lymphoma of the ocular adnexa; however, ocular adverse effects are common. To determine if a response-adapted radiation therapy strategy will result in excellent disease outcomes while reducing orbital morbidity. This single-institution, phase 2 prospective nonrandomized controlled trial of a response-adapted strategy involved 50 evaluable patients with stage I to IV indolent B-cell lymphoma of the ocular adnexa enrolled between July 2015 and January 2021. This treatment approach was also retrospectively evaluated with a separate 55-patient cohort treated between March 2013 and October 2021. All data were analyzed between November 2021 and December 2023. Patients were treated with ultralow-dose radiation therapy to 4 Gy in 2 fractions and assessed for response at 3-month intervals. Patients with persistent orbital lymphoma were offered an additional 20 Gy in 10 fractions to complete the response-adapted treatment. The primary end point was 2-year local orbital control within the irradiated field after response-adapted therapy. Secondary end points included overall survival and complete response rate. The 50 prospective patients were a median (range) of 63 (29-88) years old, and 31 (62%) were female. Among the 50 patients, 32 (64%) had mucosa-associated lymphoid tissue lymphoma, 12 (24%) had follicular lymphoma, and 6 (12%) had unclassifiable low-grade B-cell lymphoma. Thirty-one patients (62%) had stage I disease, and 36 (72%) were newly diagnosed. At a median follow-up of 37.4 (95% CI, 33.7-52.5) months, the 2-year local control rate was 89.4% (95% CI, 81.0%-98.7%), and the 2-year overall survival rate was 98.0% (95% CI, 94.1%-100%); 45 patients (90.0%; 95% CI, 78.2%-96.7%) experienced a complete response to response-adapted radiation, including 44 patients with a complete response to ultralow-dose radiation and 1 patient with a complete response after an additional 20 Gy. No local recurrences were observed among patients with a complete response to response-adapted therapy. No grade 3 or higher toxic effects were observed. In a planned subset analysis of 22 patients with newly diagnosed, untreated stage I mucosa-associated lymphoid tissue lymphoma, the 2-year local control rate was 90.7% (95% CI, 79.2%-100%), and the 2-year freedom from distant relapse rate was 95.2% (95% CI, 86.6%-100%). In this nonrandomized controlled trial, response-adapted ultralow-dose therapy for indolent orbital B-cell lymphoma resulted in reduced radiation exposure, negligible toxic effects, and excellent disease outcomes. ClinicalTrials.gov Identifier: NCT02494700.

Effect of Intrauterine Perfusion of Granulocyte Colony-Stimulating Factor on Endometrium and Blood Flow Parameters in Patients With Thin Endometrium: A Prospective Controlled Clinical Trial

To investigate the effects of intrauterine perfusion with granulocyte colony-stimulating factor (G-CSF) on the endometrial thickness, volume, and blood flow parameters of patients with thin endometrium and their clinical outcomes. We designed a prospective non-randomized synchronous controlled trial and recruited patients with thin endometrium who underwent frozen-thawed embryo transfer (FET) at Mianyang Central Hospital between September 1, 2021 and September 1, 2023. They were divided into two groups, an experimental group of patients who received the experimental treatment of intrauterine perfusion with G-CSF and a control group of patients who did not receive the experimental treatment. The general data and the clinical outcomes of the two groups were analyzed and compared. The endometrial thickness, volume and blood flow parameters of patients in the experimental group before and after intrauterine perfusion with G-CSF were analyzed. The clinical data of 83 patients were included in the study. The experimental group included 51 cases, while the control group included 31 cases. There were no significant differences in the baseline data between the two groups. The clinical pregnancy rate of the experimental group (56.86%) was higher than that of the control group (50.00%) and the rate of spontaneous abortion in the experimental group (27.59%) was lower than that in the control group (37.50%), but the differences were not statistically significant (P>0.05). In the experimental group, the postperfusion endometrial thickness ([0.67±0.1] cm) was greater than the preperfusion endometrial thickness ([0.59±0.09] cm), the postperfusion ([1.84±0.81] cm3) was greater than the preperfusion endometrial volume ([1.54±0.69] cm3), and the postperfusion vascularization flow index (VFI) (1.97±2.82) was greater than the preperfusion VFI (0.99±1.04), with all the differences being statistically significant (P<0.05). Intrauterine perfusion with G-CSF can enhance the endometrial thickness, volume, and some blood flow parameters in patients with thin endometrium.

Preliminary clinical observation and analysis of structural changes of optic nerve head in glaucoma patients after visual training

Objective: To investigate the effect of virtual reality visual training on remodeling optic nerve structures of glaucoma patients and analyze the influencing factors of visual training effect. Methods: A prospective non-randomized controlled trial was conducted. Glaucoma patients who presented to the Department of Ophthalmology, Beijing Shijitan Hospital between October 2021 and October 2022 were collected and divided into the training group or the control group according to their intentions. The training group accepted 3 months of visual training, while the control group did not. Optical coherence tomography was used to examine the disc edge area, cup volume, disc area, cup-to-disc ratio, and other parameters of the optic disc of both eyes of the patients at enrollment and after 3 months, and the changes of each parameter in the two groups were analyzed. Multivariate analysis was performed in the training group to investigate the effects of sex, age, visual field index, and mean defect on visual disc structure changes during visual training. Results: A total of 53 glaucoma patients (101 eyes) were included in the final analysis, among which the training group consisted of 27 cases (51 eyes), with 19 males and 8 females, and the age range was 48.0 (40.0, 61.0) years old. The control group comprised 26 cases (50 eyes), with 26 males and 11 females, and the age range was 54.0 (38.0, 63.0) years old. Compared with the control group, the deviation of cup volume was -0.006(-0.050, 0.015)mm3 (P<0.05), and the deviation of disc edge area was 0.00(-0.04, 0.05)mm2 (P<0. 05)in the visual training group after 3 months of visual training. The gender (OR=4.217, 95%CI=1.188-14.966) may be the influence factor of rim area. While,the mean defect (OR=1.526, 95%CI=0.245-9.491) was not that influential on rim area change. Conclusions: Visual training can increase the disc area and decrease the optic cup volume of the optic nerve in glaucoma patients. The rim area may be increased more easily after visual training in male glaucoma patients.

Intravitreal Aflibercept vs Laser Therapy for Retinopathy of Prematurity

Prospective long-term data after retinopathy of prematurity (ROP) treatment with anti-vascular endothelial growth factor injections vs laser therapy are scarce. The FIREFLEYE (Aflibercept for ROP IVT Injection vs Laser Therapy) next trial is prospectively evaluating the long-term efficacy and safety outcomes following ROP treatment with intravitreal aflibercept vs laser therapy. To evaluate 2-year ophthalmic and safety outcomes after 0.4-mg aflibercept injection or laser therapy in the 24-week randomized (2:1) FIREFLEYE trial (FIREFLEYE outcomes previously reported). This prospective nonrandomized controlled trial performed in 24 countries in Asia, Europe, and South America (2020-2025) follows up participants treated in the FIREFLEYE randomized clinical trial (2019-2021) through 5 years of age. Participants included children born very or extremely preterm (gestational age ≤32 weeks) or with very or extremely low birth weight (≤1500 g) who were previously treated with a 0.4-mg injection of aflibercept compared with laser therapy for severe acute-phase ROP. Data for the present interim analysis were acquired from March 18, 2020, to July 25, 2022. Complications of ROP treated at investigator discretion (no study treatment). Efficacy end points included ROP status, unfavorable structural outcomes, ROP recurrence, treatment for ROP complications, completion of vascularization, and visual function. Safety end points included adverse events and growth and neurodevelopmental outcomes. Overall, 100 children were enrolled (median gestational age, 26 [range, 23-31] weeks; 53 boys and 47 girls). Of these, 21 were Asian, 2 were Black, 75 were White, and 2 were of more than 1 race. At 2 years of age, 61 of 63 children (96.8%) in the aflibercept group vs 30 of 32 (93.8%) in the laser group had no ROP. Through 2 years of age, 62 of 66 (93.9%) in the aflibercept group and 32 of 34 (94.1%) in the laser group had no unfavorable structural outcomes. No new retinal detachment occurred during the study. Four children in the aflibercept group (6.1%) were treated for ROP complications before 1 year of age (2 had preexisting end-stage disease and total retinal detachment; 1 had reactivated plus disease; and 1 had recurrent retinal neovascularization not further specified). Most children were able to fix and follow a 5-cm toy (aflibercept group, 118 of 122 eyes [96.7%] among 63 children; laser group, 62 of 63 eyes [98.4%] among 33 children). High myopia was present in 9 of 115 eyes (7.8%) among 5 children in the aflibercept group and 13 of 60 eyes (21.7%) among 9 children in the laser group. No relevant differences in growth and neurodevelopmental outcomes by Bayley Scales of Infant and Toddler Development, Third Edition and Vineland Adaptive Behavior Scales, Second Edition were identified. In this nonrandomized follow-up of a randomized clinical trial comparing treatment of severe acute-phase ROP with 0.4-mg injection of aflibercept and laser, disease control was stable and visual function was appropriate in children through 2 years of age. No adverse effects on safety, including growth and neurodevelopment, were identified. These findings provide clinically relevant long-term information on intravitreal aflibercept injection therapy for ROP. ClinicalTrials.gov Identifier: NCT04015180.

Effectivity and safety of trifocal intraocular lenses and capsular tension rings implantation for cataract patients with axial high myopia.

To assess effectivity and safety of trifocal intraocular lenses (IOLs) and capsular tension rings in treating cataract patients with axial high myopia. A prospective nonrandomized controlled clinical trial was conducted. Totally 98 eyes (74 patients) who underwent femtosecond laser-assisted cataract surgery (FLACS) with trifocal IOLs were enrolled in the study and followed up for 2y after surgery: 46 eyes (33 patients) with capsular tension ring implantation in the long axial lengths (AL) group (26<AL<29 mm) and 52 eyes (41 patients) in the normal AL group (22<AL<24.5 mm). Postoperative outcomes about effectivity and safety, including the subjective and objective visual quality, and postoperative complications were assessed. Uncorrected distance visual acuity at 5 m and uncorrected intermediate visual acuity at 60 and 80 cm in the long AL group were significantly worse than those in the normal AL group at 3mo postoperatively (P<0.05). The differences in reading speed, spectacle independence and potential visual complaints between the two groups were not statistically significant (P>0.05). The dysfunctional lens index and total modulation transfer function (MTF) average height were similar between the two groups. The postoperative internal coma aberrations in the axial high myopia eyes were significantly higher than that in the normal AL group (P<0.05). The total satisfaction score in the long AL group (91.32±2.76) was slightly higher than that in the normal AL group (90.36±3.47), but there was no difference (P=0.136). A statistically negative correlation was found between corrected distance visual acuity (CDVA) and dysfunctional lens index (r=-0.382, P=0.009), and between CDVA and the total MTF average height (r=-0.374, P=0.01). But there was no significant correlation between CDVA and total satisfaction score (r=0.059, P=0.696). Postoperative complications mainly presented as posterior capsular opacity (PCO), retinal detachment and cystoid macular edema. There was no difference in the incidence of fundus disease (6.5% vs 3.8%, P=0.663) or PCO (17.4% vs 7.7%, P=0.217) between the two groups at two years. The utilization of trifocal IOL and capsular tension ring implantation is beneficial for cataract patients with axial high myopia undergoing FLACS. This approach not only ensures excellent subjective feelings and objective visual quality, but also does not increase the incidence of postoperative complications.

Patient values in patient-provider communication about participation in early phase clinical cancer trials: a qualitative analysis before and after implementation of an online value clarification tool intervention

BackgroundPatients with advanced cancer who no longer have standard treatment options available may decide to participate in early phase clinical trials (i.e. experimental treatments with uncertain outcomes). Shared decision-making (SDM) models help to understand considerations that influence patients’ decision. Discussion of patient values is essential to SDM, but such communication is often limited in this context and may require new interventions. The OnVaCT intervention, consisting of a preparatory online value clarification tool (OnVaCT) for patients and communication training for oncologists, was previously developed to support SDM. This study aimed to qualitatively explore associations between patient values that are discussed between patients and oncologists during consultations about potential participation in early phase clinical trials before and after implementation of the OnVaCT intervention.MethodsThis study is part of a prospective multicentre nonrandomized controlled clinical trial and had a between-subjects design: pre-intervention patients received usual care, while post-intervention patients additionally received the OnVaCT. Oncologists participated in the communication training between study phases. Patients’ initial consultation on potential early phase clinical trial participation was recorded and transcribed verbatim. Applying a directed approach, two independent coders analysed the transcripts using an initial codebook based on previous studies. Steps of continuous evaluation and revision were repeated until data saturation was reached.ResultsData saturation was reached after 32 patient-oncologist consultations (i.e. 17 pre-intervention and 15 post-intervention). The analysis revealed the values: hope, perseverance, quality or quantity of life, risk tolerance, trust in the healthcare system/professionals, autonomy, social adherence, altruism, corporeality, acceptance of one’s fate, and humanity. Patients in the pre-intervention phase tended to express values briefly and spontaneously. Oncologists acknowledged the importance of patients’ values, but generally only gave ‘contrasting’ examples of why some accept and others refuse to participate in trials. In the post-intervention phase, many oncologists referred to the OnVaCT and/or asked follow-up questions, while patients used longer phrases that combined multiple values, sometimes clearly indicating their weighing.ConclusionsWhile all values were recognized in both study phases, our results have highlighted the different communication patterns around patient values in SDM for potential early phase clinical trial participation before and after implementation of the OnVaCT intervention. This study therefore provides a first (qualitative) indication that the OnVaCT intervention may support patients and oncologists in discussing their values.Trial registrationNetherlands Trial Registry: NL7335, registered on July 17, 2018.

Effectiveness of a coordinated ambulatory care program for patients with mental disorders or multiple sclerosis: results of a prospective non-randomized controlled trial in South Germany.

The Psychiatry, Neurology, Psychosomatics and Psychotherapy (PNP) program of the German statutory health insurance AOK BW promotes coordinated and evidence-based specialist care with the aim of providing individualized, guideline-based outpatient care, strengthening the collaboration between health care providers, as well as reducing care costs. The purpose of this study was to evaluate its effectiveness regarding patient-reported outcomes compared to the less specialized general practitioner program (GP) and usual care (UC). AOK insured patients, who were on sick leave due to a mental disorder (affective disorder, anxiety disorder, adjustment disorder, somatoform disorder, alcohol abuse disorder, schizophrenia) or multiple sclerosis were included in the prospective non-randomized controlled study. All patients either participated in the PNP program (intervention group, IG-PNP), the general practitioner program (control group, CG-GP) or usual care (control group, CG-UC). Entropy balancing was used to adjust for baseline imbalance between groups. Primary outcome was health-related quality of life, assessed by the Short-form health survey (SF-36) 12 months after diagnosis. Secondary outcomes included symptom severity, functional health, and treatment satisfaction. Of the 14,483 insured patients who were contacted, 1,104 patients participated at baseline and 725 at follow-up. The adjusted mean differences of SF-36 sum score did not significantly differ between groups: -1.89 (95%-CI = -4.60; 0.81, p = 0.170) between IG-PNP and CG-GP, and -1.42 (95%-CI = -4.05; 1.22, p = 0.293) between PNP and CG-UC. The adjusted mean differences of secondary outcomes did not differ between groups, except for a slightly higher increase of functional health in CG-UC. We found no evidence that the PNP program is superior to the GP program or to usual care in terms of patient-reported outcomes or treatment satisfaction. The results are limited by the low response rate. Accordingly, future studies should strive for more representative samples. To improve the program, an integration of further collaborative care elements and guideline recommendations might be useful. DRKS (German Clinical Trials Register https://drks.de/search/en); identifier (DRKS00013114).

Comparison of pain intensity and impacts on oral health-related quality of life between orthodontic patients treated with clear aligners and fixed appliances: a systematic review and meta-analysis

ObjectiveThis study aimed to compare the pain intensity and impacts on oral health-related quality of life (OHRQoL) between orthodontic patients treated with clear aligners (CAs) and fixed appliances (FAs).MethodsA systematic search was conducted up to December 2022 using PubMed, Web of Science, Cochrane Central Register of Controlled Trials, and Embase. Randomized controlled trials (RCTs) and prospective non-randomized controlled trials (non-RCTs) comparing pain intensity or OHRQoL between patients treated with CAs and FAs were included. The risk of bias (RoB) of individual studies was evaluated using the Cochrane RoB tool 2.0 and ROBINS-I tool for RCTs and non-RCTs, respectively. Further, meta-analyses were separately conducted for each included study using the total oral health impact profile (OHIP)-14 and visual analog scale (VAS) scores to evaluate OHRQoL and pain intensity, respectively.ResultsOverall, 12 studies (5 RCTs and 7 non-RCTs) were included in the study. Subgroup analyses conducted according to the total OHIP-14 scores revealed that patients treated with CAs had higher OHRQoL at 1 week, 1 month, and 6 months of the treatment. Meanwhile, subgroup analyses conducted according to the VAS scores revealed that pain levels were lower in the CA group only at 3 and 4 days of the treatment.ConclusionsPatients treated with clear aligners had higher OHRQoL than those treated with fixed appliances during orthodontic treatment. However, OHRQoL appeared to be similar between the two groups at the end of the treatment. Moreover, patients treated with clear aligners experienced lesser pain than those treated with fixed appliances on the third and fourth day after the initial treatment. The difference in pain intensity between the two treatment modalities was not noted at other time points.

Muscle Strength and Efficiency of Muscle Activities Recovery Using Single-Joint Type Hybrid Assistive Limb in Knee Rehabilitation after Anterior Cruciate Ligament Reconstruction.

Decreased muscle strength often occurs after anterior cruciate ligament (ACL) reconstruction; this can include muscle atrophy, neuromuscular dysfunction, and reduced force generation efficiency. Hybrid assistive limb (HAL) technology, which integrates an interactive biofeedback system connecting the musculoskeletal system to the brain and spinal motor nerves, offers a potential intervention. Our study, conducted from March 2018 to August 2023 using knee HAL single-joint technology, was a prospective non-randomized controlled trial involving 27 patients who had undergone arthroscopic ACL reconstruction. They were split into two groups: HAL (18 patients) and control (nine patients). Beginning 18 weeks after their surgery, the HAL group participated in three weekly sessions of knee HAL-assisted exercises. Both the HAL and control groups underwent isokinetic muscle strength tests at postoperative weeks 17 and 21. Testing utilized an isokinetic dynamometer at 60°/s, 180°/s, and 300°/s. The Limb Symmetry Index (LSI) was employed to measure side-to-side differences. The HAL group showed significant LSI improvements in peak extension torque across all testing velocities and for peak flexion torque at 60°/s and 300°/s. The rate of change in LSI for peak flexion torque at 300°/s was significantly higher post-measurements (p = 0.036; effect size = 1.089). The change rate for LSI in peak extension torque at 300°/s and all peak flexion torques showed medium to large effect sizes in Cohen's d. In conclusion, knee HAL single-joint training positively influenced muscle strength recovery and efficiency. The HAL training group exhibited superior muscle strength at various isokinetic testing velocities compared to the control group.

Stereotactic radiosurgery versus whole-brain radiotherapy in patients with 4–10 brain metastases: A nonrandomized controlled trial

Background and PurposeThere is no randomized evidence comparing whole-brain radiotherapy (WBRT) and stereotactic radiosurgery (SRS) in the treatment of multiple brain metastases. This prospective nonrandomized controlled single arm trial attempts to reduce the gap until prospective randomized controlled trial results are available. Material and MethodsWe included patients with 4–10 brain metastases and ECOG performance status ≤ 2 from all histologies except small-cell lung cancer, germ cell tumors, and lymphoma. The retrospective WBRT-cohort was selected 2:1 from consecutive patients treated within 2012–2017. Propensity-score matching was performed to adjust for confounding factors such as sex, age, primary tumor histology, dsGPA score, and systemic therapy. SRS was performed using a LINAC-based single-isocenter technique employing prescription doses from 15-20Gyx1 at the 80% isodose line. The historical control consisted of equivalent WBRT dose regimens of either 3Gyx10 or 2.5Gyx14. ResultsPatients were recruited from 2017–2020, end of follow-up was July 1st, 2021. 40 patients were recruited to the SRS-cohort and 70 patients were eligible as controls in the WBRT-cohort. Median OS, and iPFS were 10.4 months (95%-CI 9.3-NA) and 7.1 months (95%-CI 3.9–14.2) for the SRS-cohort, and 6.5 months (95%-CI 4.9–10.4), and 5.9 months (95%-CI 4.1–8.8) for the WBRT-cohort, respectively. Differences were non-significant for OS (HR: 0.65; 95%-CI 0.40–1.05; P =.074) and iPFS (P =.28). No grade III toxicities were observed in the SRS-cohort. ConclusionThis trial did not meet its primary endpoint as the OS-improvement of SRS compared to WBRT was non-significant and thus superiority could not be proven. Prospective randomized trials in the era of immunotherapy and targeted therapies are warranted.

Association between autologous transfusion and recurrence-free survival in patients with hepatocellular carcinoma after resection: A prospective nonrandomized controlled trial.

e16206 Background: To investigate whether preoperative stored autologous transfusion has a significant effect on recurrence-free survival of patients with primary hepatocellular carcinoma (HCC). Methods: Recurrence-free survival (RFS), overall survival, and perioperative morbidity were compared among patients with or without autologous transfusion at our medical center between January 2019 and December 2021. Patients who received autologous transfusion were matched based on propensity scores to patients who did not, in order to reduce confounding due to baseline differences. This study was registered on ClinicalTrials.gov (NCT02654028). Results: Of the 618 patients in the analysis, 399 (64.6%) received autologous transfusion and 219 (35.4%) did not receive autologous transfusion. By 30 July 2022, the median RFS time had been achieved. Patients with or without autologous transfusion had similar RFS before (hazard ratio 1.01, 95%CI 0.82-1.24) or after propensity score analysis (hazard ratio 1.04, 95%CI 0.82-1.31). However, the median overall survival was not achieved. Patients with or without autologous transfusion also had similar overall survival before (hazard ratio 1.15, 95%CI 0.84-1.56) or after propensity score analysis (hazard ratio 1.26, 95%CI 0.88-1.79). Moreover, subgroup analyses found that patients with or without autologous transfusion had similar RFS or overall survival among those with early, intermediate, or advanced stage disease. The two groups also had similar rates of perioperative mortality and morbidity. Conclusions: Preoperative stored autotransfusion had no significant effect on survival in patients with HCC who underwent liver resection. Clinical trial information: NCT02654028 .

Reduced humoral immune response after mRNA vaccination correlates with breakthrough SARS-CoV-2 infection in ocrelizumab-treated multiple sclerosis patients (P12-3.005)

Reduced humoral immune response after mRNA vaccination correlates with breakthrough SARS-CoV-2 infection in ocrelizumab-treated multiple sclerosis patients (P12-3.005)

A non-randomized controlled trial to assess the protective effect of SMC in the context of high parasite resistance in Uganda

BackgroundUntil recently, due to widespread prevalence of molecular markers associated with sulfadoxine-pyrimethamine (SP) and amodiaquine (AQ) resistance in east and southern Africa, seasonal malaria chemoprevention (SMC) has not been used at scale in this region. This study assessed the protective effectiveness of monthly administration of SP + AQ (SPAQ) to children aged 3–59 months in Karamoja sub-region, Uganda, where parasite resistance is assumed to be high and malaria transmission is seasonal.MethodsA two-arm quasi-experimental, open-label prospective non-randomized control trial (nRCT) was conducted in three districts. In two intervention districts, 85,000 children aged 3–59 months were targeted to receive monthly courses of SMC using SPAQ during the peak transmission season (May to September) 2021. A third district served as a control, where SMC was not implemented. Communities with comparable malaria attack rates were selected from the three districts, and households with at least one SMC-eligible child were purposively selected. A total cohort of 600 children (200 children per district) were selected and followed using passive surveillance for breakthrough confirmed malaria episodes during the five-month peak transmission season. Malaria incidence rate per person-months and number of malaria episodes among children in the two arms were compared. Kaplan–Meier failure estimates were used to compare the probability of a positive malaria test. Other factors that may influence malaria transmission and infection among children in the two arms were also assessed using multivariable cox proportional hazards regression model.ResultsThe malaria incidence rate was 3.0 and 38.8 per 100 person-months in the intervention and control groups, respectively. In the intervention areas 90.0% (361/400) of children did not experience any malaria episodes during the study period, compared to 15% (29/200) in the control area. The incidence rate ratio was 0.078 (95% CI 0.063–0.096), which corresponds to a protective effectiveness of 92% (95% CI 90.0–94.0) among children in the intervention area.ConclusionSMC using SPAQ provided high protective effect against malaria during the peak transmission season in children aged 3–59 months in the Karamoja sub-region of Uganda.

Impact of a clinical pharmacist on optimising the quality use of medicines according to the acute coronary syndrome (ACS) secondary prevention guidelines and medication adherence following discharge in patients with ACS in Sri Lanka: a prospective non-randomised controlled trial study protocol

ObjectivesEnsuring quality use of medicines (QUM) through clinical pharmacy services can improve therapeutic outcomes of patients diagnosed with acute coronary syndrome (ACS). The major objective of this study is to...

Symptoms-triggered approach versus fixed-scheduled approach of benzodiazepines for management of alcohol withdrawal syndrome: Non-randomized controlled trial.

Alcohol withdrawal syndrome, if untreated, can lead to potentially life-threatening complications. Benzodiazepines are the drugs of choice for the treatment of alcohol withdrawal syndrome. We aimed to compare the symptoms-triggered approach and fixed-dose approach of benzodiazepine administration for treatment of alcohol withdrawal syndrome in regard to the health care utilization measured by the total dose of benzodiazepines, length of hospital stays, and 90-day readmissions rate. A single-center prospective non-randomized controlled trial included all patients diagnosed with alcohol withdrawal syndrome. The group of patients admitted between October 1, 2019, and September 30, 2020, were treated with the fixed-scheduled approach (n=150), while all patients admitted between November 1, 2020, to October 31, 2021, were treated with the symptoms-trigger approach (n=50). The fixed-dose approach group showed a significant higher 90-day readmissions rate (HR: 2.61; 95% CI=1.18, 6.84; p=0.01). Kaplan-Meier survival analysis showed a significantly shorter duration to the first readmission in the fixed-scheduled approach group (HR: 2.3; 95% CI=5.6, 1.16; p=0.02). The symptoms-triggered approach group required a significantly lower dose of diazepam (40mg vs. 10mg; p<0.01) and a higher dose of thiamine (800mg vs. 600mg; p<0.01). Length of hospital stay was significantly increased in the symptoms-triggered approach group (3.9 vs. 2.2 days; p<0.01). The use of a symptoms-triggered approach to treat alcohol withdrawal syndrome was associated with a lower 90-day readmission rate, prolonged period to the first readmission, and reduced total dose of benzodiazepines, but longer length of hospital stays. The symptoms-triggered approach is safe, cost-effective, and associated with reduced alcohol dependence relapse.

P-50952666-374 - Is autologous periosteum a better alternative to commercially available xenogeneic membranes? A preliminary prospective non-randomized controlled trial.

P-50952666-374 - Is autologous periosteum a better alternative to commercially available xenogeneic membranes? A preliminary prospective non-randomized controlled trial.

Evaluation of Postoperative Warming Care Protocol for Thermal Comfort and Temperature Management Immediately After Surgery: Nonrandomized Controlled Trial

PurposeThis study aimed to determine the effects of a warming care protocol (WCM) on temperature control and thermal comfort perception in hypothermia following major abdominal surgery. DesignA prospective nonrandomized controlled trial. MethodsA total of 54 patients undergoing major abdominal surgery were assigned to receive routine care (control group, 27 patients) or the WCM (intervention group, 27 patients). The body temperature (core and peripheral) was measured, and physical symptoms were monitored every hour for 4 hours after arriving at the ward and then every 4 hours for up to 12 hours. FindingsThe temperature gap, calculated as the difference between the core and skin temperatures, was similar between the control and intervention groups at the end of surgery. However, the temperature gap in the intervention group decreased within 3 hours after arrival at the ward and remained lower than that in the control group. The visual analog scale score for postoperative thermal discomfort was significantly lower in the intervention group than in the control group, indicating achievement of higher comfort with the warming intervention. ConclusionsPatients were warmed using active warming methods under the WCM, which in turn increased the thermal comfort perception with the body temperature. Postoperative patients often require warming care for thermal comfort, which may be improved by proper observation and management within 1 to 2 hours postoperatively. Our results indicate that nurses could effectively warm the patient to maintain normal body temperature following surgery not only to improve thermal comfort, but also to prevent shivering and possibly various postoperative complications.