Prospective, randomized study comparing two different regimens of split-dose polyethylene glycol and their effect on endoscopic outcomes.

BACKGROUND: Different split regimens of polyethylene glycol are routinely used and no guidelines are available to select an optimal protocol of ingestion. This study aims to compare the efficacy and side effect profile of two different regimens of polyethylene glycol bowel preparation solution: PEG (3 + 1) vs. PEG (2 + 2). METHODS: 240 patients above the age of 18 years were included in the study between June 1st and November 31st, 2023. Patients were randomly assigned either to Group A, consisting of 115 patients receiving a 3 L of PEG the night before the colonoscopy, and 1 L the same morning of the procedure. Or to group B, where 125 patients ingested 2 L the night before the procedure, and the remaining 2 L the same morning. The cleansing efficacy was evaluated by the attending endoscopist using the Boston Bowel Preparation Scale, through a score assigned for each segment of the colon (0-3). Side effects, tolerability, and willingness to retake the same preparation were listed by an independent investigator using a questionnaire administered before the procedure. RESULTS: A higher percentage of patients had gastric fullness with the 3 + 1 vs. 2 + 2 preparation (58.3% vs. 31.2%; p <.001). A higher Boston bowel preparation score was seen in patients who took the 2 + 2 vs. 3 + 1 preparation (7.87 vs. 7.23). Using the 2 + 2 preparation was significantly associated with higher Boston bowel preparation scores vs. the 3 + 1 preparation (OR = 1.37, p =.001, 95% CI 1.14, 1.64). After adjustment over other variables (age, gender, comorbidities, previous abdominal surgeries, presence of adenoma, and time between last dose and colonoscopy), results remained the same (aOR = 1.34, p =.003, 95% CI 1.10, 1.62). CONCLUSION: While both (2 + 2) and (3 + 1) regimens of polyethylene glycol are a good choice for a successful colonoscopy, we recommend the use of (2 + 2) regimen for its superior efficacy in bowel cleansing.

Intentional Replantation: No Longer a Last Resort for Saving a Natural Tooth.

Intentional replantation (IR) is the intentional extraction of a tooth followed by its replacement back into its socket for the purpose of performing a root-end surgery or other necessary repairs. The procedure may be considered a favorable alternative to conventional microsurgery, especially when surgical access is restricted due to specific anatomical challenges. With advancements in magnification, bioceramics, and instrumentation, IR has become a well-established, scientifically supported treatment modality and is cost-effective when compared to single-implant placement. This article discusses the rationale and indications for IR, describes treatment protocols, and reports on its outcomes.

A standardized treatment protocol for pilonidal disease can influence the health mindset of adolescents.

PURPOSE: Pilonidal disease (PD) significantly impacts patients' quality of life and requires regular maintenance behaviors to achieve cure. Health mindset is a psychological construct which can influence health behaviors and outcomes, with a growth mindset being associated with better outcomes than a fixed. We propose that participation in a standardized treatment protocol can affect the health mindset for adolescents with pilonidal disease. METHODS: PD patients' demographics, recurrence, and comorbidities were prospectively collected from 2019 to 2022. We assessed patients' mindset score at initial presentation using the validated Three-Item Mindset Scale (1-6) then reassessed during follow-up. t-test was used to compare baseline and follow-up mindset scores and stratified by recurrence or comorbidities. p ≤ 0.05 was considered significant. RESULTS: A total of 207 PD patients (108 males, 99 females) with mean age 18.2 ± 3.7 years were followed for 351 ± 327 days. Mean baseline mindset score (4.76 ± 1.27) was significantly lower than mean follow-up mindset score (5.03 ± 1.18, p = 0.049). Baseline mindset score was significantly lower among patients with PD recurrence (4.00 ± 0.66) compared to those without recurrence (4.8 ± 1.29, p = 0.05). Among patients with PD recurrence, mean baseline mindset score (4.00 ± 0.66) was significantly lower than mean follow-up mindset score (5.27 ± 0.93, p = 0.0038). Patient comorbidity did not affect the baseline or follow-up mindset score. CONCLUSIONS: Participation in a standardized treatment protocol is associated with the development of a stronger growth mindset over time for patients with PD. Furthermore, a growth mindset was linked to lower recurrence rate than a fixed mindset. Further investigations into how treatment approaches can work in concert with health mindset are proposed.

Two-Stage Treatment Protocol of Fungal Periprosthetic Hip and Knee Joint Infections: the Clinical Experience from a Single Center Experience.

PURPOSE OF THE STUDY: To evaluate the clinical results and safety of fungal periprosthetic joint Infections (fPJIs) using two-stage treatment protocol. MATERIAL AND METHODS: 8 patients with fPJIs (3 hips and 5 knees) using two-stage revision were reviewed retrospectively and followed up at least 2 years. The preoperative demographic data, two-stage treatment protocol, results of microbiology and histologic workup and postoperative follow-up results (reimplantation success rate and infection free time) were recorded. RESULTS: 7 patients got successful reimplantation, with a 75% reimplantation success rate. Two patients got knee arthrodesis eventually. All patients were infection free with a median follow-up of 4.0 ± 2.0 years (range, 2-7 years). Of them, Candida species were found in 7 patients, while non-Candida specimen was only isolated in 1 patient with Aspergillus. Only 2 patients had coexisting bacterial infection (Methicillin-resistant coagulase-negative Staphylococci and Proteus mirabilis respectively). The average interval between the initial surgery and diagnosis of fPJIs was 21.50±34.79 months (range, 4-104 months). The mean time of spacer implantation was 7.75±2.77 months (range, 6-14 months). None serious complication or above knee amputation was found. DISCUSSION: fPJIs are very rare and considerable challenge after total hip or knee arthroplasty. The goal of therapy is to eradicate local infection and maintain function. Candida species were the most common pathogen. The duration between spacer placement and staged reimplantation was highly variable, and generally dependent upon the results of joint aspirates and infl ammatory markers. The current study shows that the two-stage treatment protocol is recommended for fungal periprosthetic hip and knee joint infections. CONCLUSIONS: The two-stage treatment protocol is recommended for fungal periprosthetic hip and knee joint infections. The safety and effi cacy of biantibiotical impregnated (antifungal + antibiotics) cement spacer is confi rmed. Further evidence-based work is needed to determine the optimal drug dose and reimplantation time. KEY WORDS: two-stage treatment protocol, fungal periprosthetic infections, hip spacer, knee spacer.

Efficacy of 660 nm Photobiomodulation in Burning Mouth Syndrome Management: A Single-Blind Quasi-Experimental Controlled Clinical Trial.

Background: Burning mouth syndrome (BMS) is characterized by a burning sensation of the oral mucosa without any evidence of clinical signs or underlining condition. Several treatment modalities have been utilized with various results and levels of evidence. Lately, photobiomodulation (PBM) has emerged as a noninvasive effective therapy due to its anti-inflammatory and biostimulatory effects, especially the low-power laser setting of red wavelength. Objective: This single-blind quasi-experimental controlled clinical trial aimed to evaluate the PBM effectiveness at a low level of red laser light in patients with BMS compared with sham control. Materials and methods: Thirty patients diagnosed with BMS were consecutively assigned to intervention (PBM therapy) and control (sham) groups. The protocol for PBM dosimetry was as follows: laser 660 nm; spot size: 0.04 cm2; power output: 100 mW; emission mode: continuous wave; power density: 6 J/cm2; irradiation time: 10 sec per point within 1 cm2 surface area of the symptomatic area. The treatment protocol was based on once a week for a total of 10 sessions. Results: Our results showed no statistically significant difference in reduction of pain intensity between the two groups at all the evaluated timepoints during the course of treatment. However, in both groups, we observed a statistically significant reduction of maximum pain intensity of 50% compared with patient-self reporting before the treatment. Conclusions: Further randomized clinical trials to validate our positive results with a large sample size with a long-term follow-up and understanding further the sham placebo effect are warranted.

Results of a simple treatment protocol for aseptic femoral shaft nonunion in 330 patients.

INTRODUCTION: Our primary aim of the study was to assess the results of a treatment protocol for aseptic femoral shaft nonunion treated by three techniques - Exchange Nailing (EN), Plate Augmentation (PA), and Exchange Nailing combined with Plate augmentation (NP). The secondary objective was to assess the radiological outcome, duration of surgery (DOS) and need for blood transfusion (BT) in all the three groups. MATERIALS AND METHODS: We analyzed 330 patients treated for AFNU between Jan 2007 and Dec 2019. Using a simple treatment algorithm, EN, PA and NP were performed in 24,183 and 123 patients respectively. Patients in all the three groups were assessed for radiological-union (union rate and time to union), DOS and BT. RESULTS: Of these 330 patients, 327 (99 %) patients achieved radiological union at a mean duration of 6.07 months. Union rate is highest with NP followed by PA and EN. The union rate in patients with NP, PA and EN were 100 %, 99.5 % and 91.7 % respectively (p < 0.01). Time to union was lowest for NP followed by PA and EN (p < 0.001).The mean time to union for NP, PA and EN were 3.76, 7.2and 9.21 months respectively (p < 0.001). The mean DOS in minutes for NP, EN and PA was 107, 94 and 82 respectively (p < 0.01). The mean need for BT in the form of packed red blood cells for NP, PA and EN were 1.95, 1.87 and 1.38 units respectively (p < 0.01). CONCLUSION: Following a simple algorithm to decide treatment protocol on a case-to case basis helps to achieve good results in an optimal time period. When compared with EN and PA, NP is associated with 100 % union rate with least time to union making NP a reasonably effective procedure with a very high success rate. LEVEL OF EVIDENCE: IV.

Quantitative bias analysis for external control arms using real-world data in clinical trials: a primer for clinical researchers.

Development of medicines in rare oncologic patient populations are growing, but well-powered randomized controlled trials are typically extremely challenging or unethical to conduct in such settings. External control arms using real-world data are increasingly used to supplement clinical trial evidence where no or little control arm data exists. The construction of an external control arm should always aim to match the population, treatment settings and outcome measurements of the corresponding treatment arm. Yet, external real-world data is typically fraught with limitations including missing data, measurement error and the potential for unmeasured confounding given a nonrandomized comparison. Quantitative bias analysis (QBA) comprises a collection of approaches for modelling the magnitude of systematic errors in data which cannot be addressed with conventional statistical adjustment. Their applications can range from simple deterministic equations to complex hierarchical models. QBA applied to external control arm represent an opportunity for evaluating the validity of the corresponding comparative efficacy estimates. We provide a brief overview of available QBA approaches and explore their application in practice. Using a motivating example of a comparison between pralsetinib single-arm trial data versus pembrolizumab alone or combined with chemotherapy real-world data for RET fusion-positive advanced non-small cell lung cancer (aNSCLC) patients (1-2% among all NSCLC), we illustrate how QBA can be applied to external control arms. We illustrate how QBA is used to ascertain robustness of results despite a large proportion of missing data on baseline ECOG performance status and suspicion of unknown confounding. The robustness of findings is illustrated by showing that no meaningful change to the comparative effect was observed across several 'tipping-point' scenario analyses, and by showing that suspicion of unknown confounding was ruled out by use of E-values. Full R code is also provided.

Long-Term Results of Oral Propranolol Treatment Protocol for Periocular Infantile Hemangioma: Should There Be Any Contraindication?

PURPOSE: The authors report long-term results of the oral propranolol treatment protocol for periocular infantile hemangioma regardless of conventional indications. METHODS: This is a retrospective study (2008-2018) on children with propranolol treatment protocol for periocular infantile hemangioma and last follow-up (FU) of ≥4 months after treatment and age of >24 months. After systemic evaluation, it was started with 0.5 and increased by 0.5 every 3 days to reach 2 mg/kg/day. If there was no good response, it would be gradually increased up to 3 mg/kg/day. Tapering (0.5 mg/kg/day every 4 weeks) was started when patients were on treatment for ≥6 months and ≥12 months old and there was no change in the infantile hemangioma size for ≥3 months. Rebound growth was based on the parents' report and would be treated by increasing the dose to at least 2 mg/kg/day for 3 months. FU was either in-person or via social media. Change in periocular infantile hemangioma size on the photos was scored by 3 masked observers (visual analog scale) and presented as excellent (≥50% reduction), good (1%-49%), fair (no change), and failure (enlarged). RESULTS: Forty-three patients were included. Orbital involvement was in 49%, ptosis in 58%, and risk of amblyopia in 63%. Mean treatment, tapering, and FU duration were 37, 13, and 74 months, respectively. Mean age at presentation, start of propranolol treatment protocol, tapering, stop, and last FU were 1.5, 5, 29, 42, and 78 months, respectively. Twenty-seven patients received 2, seven 2.5, and nine 3 mg/kg/day. Mean visual analog scale significantly increased from 43% (FU1) to 92% (last FU) when 97.6% of patients showed an excellent response. The remaining skin lesions were observed in 35%. No side effect was reported. CONCLUSIONS: Long-term results of the propranolol treatment protocol for periocular infantile hemangioma showed an excellent response in 97.6% of patients with no side effects. A residual skin lesion was observed in 1/3 of the patient.

Influence of prior treatment protocol on intravitreal dexamethasone implant behavior in patients with diabetic macular edema in real-world practice.

BACKGROUND AND OBJECTIVE: Intravitreal dexamethasone implant (DEXI) has been placed as an effective option to treat diabetic macular edema (DME). However, there is no consensus on the best time to introduce it. We conducted a study to evaluate anatomical and functional behavior after the first DEXI according to previous treatment. RESEARCH DESIGN AND METHODS: This retrospective, real-world study between 2013 and 2020 investigated changes in best-corrected visual acuity (BCVA) and central macular thickness (CMT at months 2 and 6 after the first DEXI in DME. Patients were divided into naive, early switch (≤3 anti-VEGF injections), or late switch (>3 anti-VEGF injections) groups. RESULTS: Among 112 consecutive eyes, mean BCVA and CMT improved significantly in all groups at month 2, with no difference between them. However, this improvement was not maintained at 6 months. The Naíve group presented better BCVA all over the study period. The previously treated groups, which started with worse initial visual acuity, showed more visual gain without reaching the BCVA of the naive group. CMT performance was similar between groups. CONCLUSIONS: There was similar anatomical and functional behavior in all groups. Poorer visual acuity at baseline was associated with worse functional outcome despite good anatomic response.

A real-world study of the effectiveness and safety of apatinib-based regimens in metastatic triple-negative breast cancer.

PURPOSE: This investigation sought to examine the efficacy and safety of low-dose apatinib used alongside chemotherapy in the clinical management of patients with metastatic triple-negative breast cancer (TNBC) within a real-world setting, whilst comparing the outcomes with those treated solely with chemotherapy. METHODS: This case series study analyzed clinical data and treatment outcomes of 163 patients with metastatic TNBC who underwent rescue treatment at the Medical Oncology Department of Clinical Oncology, Fujian Cancer Hospital, School of Fujian Medical University, China, between October 2011 and January 2023. All the patients underwent rescue treatment with either chemotherapy alone or apatinib (250 mg/day) combined with chemotherapy. The study's primary outcome was progression-free survival (PFS), whereas the secondary outcomes included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety profiles. RESULTS: The study was designed to compare two groups [1]. Out of the 163 TNBC patients who participated in the study, 107 individuals (65.6%) received treatment based on chemotherapy, whereas 56 patients (34.4%) were given treatment based on a combination of low-dose apatinib (250 mg/day) and other treatments, including chemotherapy. After propensity score matching (PSM), the objective response rate (ORR) and disease control rate (DCR) of patients with advanced triple-negative breast cancer (TNBC) who received apatinib-based treatment were 50.0 and 90.0%, respectively, while they were 6.7 and 20.0%, respectively, for the chemotherapy-based group (P < 0.001). The group that received apatinib-based treatment showed superior results in both PFS and OS compared to the group that received chemotherapy. The median PFS and OS for the apatinib-based group were 7.8 and 20.3 months, respectively, while they were only 2.2 months and 9.0 months, respectively, for the chemotherapy-based group (P < 0.001) [2]. Patients who were administered combo therapies, including PD-1 inhibitors, were excluded. In total, 97 patients received chemotherapy alone, while 34 patients were treated with apatinib in combination with chemotherapy. After propensity score matching (PSM), the ORR and DCR for the total group who received combo therapies were 44.4 and 81.5%, respectively, while they were 11.1 and 22.2%, respectively, for the chemotherapy alone group (P < 0.001). The group receiving both apatinib and chemotherapy displayed notable advantages over the group solely receiving chemotherapy in regards to PFS and OS for the entirety of the population. The PFS was found to be 7.8 months in comparison to 2.1 months (P < 0.001) and the OS was 21.1 months in contrast to 9.0 months (P < 0.001). Apatinib combined with chemotherapy induced grade 3/4 hematological toxicities, including neutropenia (8.8%) and thrombocytopenia (2.9%). Additionally, non-hematological toxicities were commonly observed, such as Hand-foot syndrome (35.3%), proteinuria (26.5%), hypertension (61.8%), higher alanine aminotransferase levels (26.5%), and fatigue (35.3%). The most frequent non-hematological grade 3/4 toxicities were Hand-foot syndrome (2.9%) and hypertension (5.9%). The study did not report any fatal adverse effects. CONCLUSIONS: The combination of low-dose apatinib with chemotherapy has proven to be more effective than chemotherapy alone in treating metastatic triple-negative breast cancer (TNBC). Additionally, the occurrence of grade 3/4 non-hematologic toxicities was significantly lower compared to the recommended dose of apatinib.

Late Cardiac Toxic Effects Associated With Treatment Protocols for Hodgkin Lymphoma in Children.

Importance: Contemporary North American trials for children with Hodgkin lymphoma (HL) have decreased radiation therapy (RT) use and increased pharmacologic cardioprotection but also increased the cumulative doxorubicin dose, making overall treatment consequences for late cardiac toxic effects uncertain. Objective: To estimate the risk of cardiac toxic effects associated with treatments used in modern pediatric HL clinical trials. Design, Setting, and Participants: For this cohort study, Fine and Gray models were fitted using survivors in the Childhood Cancer Survivor Study who were diagnosed with HL between January 1, 1970, and December 31, 1999, and were followed for a median of 23.5 (range, 5.0-46.3) years. These models were applied to the exposures in the study population to estimate the 30-year cumulative incidence of cardiac disease. The study population comprised patients with intermediate-risk or high-risk HL treated in 4 consecutive Children's Oncology Group clinical trials from September 2002 to October 2022: AHOD0031, AHOD0831, AHOD1331, and S1826. Data analysis was performed from April 2020 to February 2023. Exposures: All patients received chemotherapy including doxorubicin, and some patients received mediastinal RT, dexrazoxane, or mediastinal RT and dexrazoxane. Main Outcomes and Measures: Estimated 30-year cumulative incidence of grade 3 to 5 cardiac disease. Results: The study cohort comprised 2563 patients, with a median age at diagnosis of 15 (range, 1-22) years. More than half of the patients were male (1357 [52.9%]). All 2563 patients received doxorubicin, 1362 patients (53.1%) received mediastinal RT, and 307 patients (12.0%) received dexrazoxane. Radiation therapy use and the median mean heart dose among patients receiving RT decreased, whereas the planned cumulative dose of doxorubicin and use of dexrazoxane cardioprotection increased. For patients treated at age 15 years, the estimated 30-year cumulative incidence of severe or fatal cardiac disease was 9.6% (95% CI, 4.2%-16.4%) in the AHOD0031 standard treatment group (enrolled 2002-2009), 8.6% (95% CI, 3.8%-14.9%) in the AHOD0831 trial (enrolled 2009-2012), 8.2% (95% CI, 3.6%-14.3%) in the AHOD1331 trial (enrolled 2015-2019), and 6.2% (95% CI, 2.7%-10.9%) in the S1826 trial (enrolled 2019-2022), whereas the expected rate in an untreated population was 5.0% (95% CI, 2.1%-9.3%). Despite the estimated reduction in late cardiac morbidity, the frequency of recommended echocardiographic screening among survivors will increase based on current guidelines. Conclusions and Relevance: In this cohort study of sequential HL trials, reductions in the proportion of children receiving mediastinal RT and increases in dexrazoxane use were estimated to offset the increased doxorubicin dose and produce a net reduction in late cardiac disease. Further studies on dexrazoxane are warranted to confirm whether its role in reducing cardiac toxic effects is maintained long term. These findings suggest that survivorship follow-up guidelines should be refined to align with the risks associated with treatment.

American Association for the Surgery of Trauma/American College of Surgeons Committee on Trauma: Clinical protocol for damage-control resuscitation for the adult trauma patient.

ABSTRACT: Damage-control resuscitation in the care of critically injured trauma patients aims to limit blood loss and prevent and treat coagulopathy by combining early definitive hemorrhage control, hypotensive resuscitation, and early and balanced use of blood products (hemostatic resuscitation) and the use of other hemostatic agents. This clinical protocol has been developed to provide evidence-based recommendations for optimal damage-control resuscitation in the care of trauma patients with hemorrhage.

Retained fragmented needle in intravenous drug users: An institutional experience and treatment protocol.

Retained needle fragments can occur in intravenous drug user (IVDU), which can lead to significant morbidity and mortality. The aim of present study is to give an overview of our institutional experience and treatment protocol followed for such patients. IVDU with retained fragment of fractured needle were taken from the patient presenting in Emergency, Medicine and CTVS departments with history of IVDU, from January 2019 to December 2020. Six patients were found with retained broken needles. Detailed history, examination and investigations were done. The needle was removed under local anaesthesia successfully in all patients. IVDU with retained broken needle poses risk for catastrophic complications along with possibility of local complications. A systematic approach in managing such patients is required. These broken needles can be successfully retrieved as day care procedure. Lastly, IVDUs with fractured needles pose threat to the caregivers who should take caution to avoid iatrogenic injury.

Prospective study to assess the efficacy and safety of a noninvasive electro-muscular stimulation for improvement of muscle strength and muscle toning of the extremities.

OBJECTIVE: We sought to evaluate the safety and efficacy of an electrical muscle stimulation (EMS) device in the improvement of muscle strength and toning of the upper extremities. This device, which is FDA-cleared as a two-channel muscle stimulator, provides up to eight electrodes with waveforms inducing muscle stimulation. Although a prior study demonstrated it is safe and effective for use in the abdomen, this system, which has electrodes specifically designed for the extremities, has not previously been evaluated in the upper extremities. METHODS: Forty-five subjects enrolled in the study to assess improvement in arm (i.e., bicep and tricep muscle) strength, and appearance following a protocol of treatments with this bioelectric muscle activation (BMA) device. All subjects received four 30-min EMS treatment sessions in Arm mode-twice weekly for 2 weeks and at least 48 h apart. Follow up visits were also scheduled 30- and 90-days after treatment. Strength was measured with a dynamometer device at baseline, at the final treatment session, and at the posttreatment 30- and 90-day assessment. Subject satisfaction was assessed gauging overall comfort of the treatment and satisfaction including willingness to recommend to others. The changes in strength between initial treatment and final treatment, as well as 30 and 90-day assessment were evaluated. Clinical photography at these visits was also assessed for each patient. Patients were instructed to not modify their normal exercise routine while participating in this study. RESULTS: All 45 subjects completed the treatment protocol. Most patients showed an improvement in muscle strength from the initial to final treatment (i.e., the fourth treatment). Specifically, the maximum bicep strength increased by a mean of 7.5 lbs (22.83%, p = 0.006), while the average increased by a mean of 8.2 lbs (25.76%, p = 0.001) during this period. Similarly, the maximum tricep strength from initial to final treatment increased by a mean of 10.0 lbs (23.16%, p = 0.000), while the average increased by a mean of 9.6 lbs (27.12%, p = 0.000). Thirty days after the last treatment, the maximum bicep strength increased by a mean of 13.3 lbs (34.13%, p = 0.001) while the average increased by a mean of 13.6 lbs (37.05%, p = 0.000) during this period. Similarly, the maximum tricep strength from initial to 30 days postfinal treatment increased by a mean of 10.9 lbs (24.37%, p = 0.000), while the average increased by a mean of 10.5 lbs (29.37%, p = 0.000). Finally, 90 days after the last treatment, the maximum bicep strength increased by a mean of 19.4 lbs (48.4%, p = 0.000), while the average increased by a mean of 17.4 lbs (46.53%, p = 0.000) during this period. Similarly, the maximum tricep strength from initial to 90 days postfinal treatment increased by a mean of 10.8 lbs (27.12%, p = 0.000), while the average increased by a mean of 10.0 lbs (30.94%, p = 0.001). CONCLUSION: This device was well tolerated and resulted in increased strength measurements in the upper extremities, as assessed by a dynamometer, which were sustained at 30 and 90 days.

Long-term follow-up results of a pilot study for nodular basal cell carcinoma with PDT using partial home treatment protocol.

SIGNIFICANCE: Evaluate a photodynamic therapy (PDT) protocol for low-risk basal cell carcinoma (BCC) treatment that requires less time spent at the hospital and is less painful. APPROACH: Eight BCCs were selected, debulked, and received 20 % methyl aminolevulinate cream. After 3 h, the first irradiation was performed at the hospital (20 min, 150 J/cm2). Then, the cream was re-applied, and a portable irradiation prototype was fixed to the skin around the lesion. After 1.5 h, the patients turned on the prototype for irradiation at home (for 2 h, totalizing 312 J/cm2). Disease-free survival rate and pain score during irradiations were evaluated. RESULTS: The clearance at 30 days after PDT was 87.5 % by histological analysis. The mean follow-up was 21.5 months and the recurrence-free survival at 22 months was 75 %. The pain score was significantly lower at home. CONCLUSIONS: A potentially less painful and more comfortable PDT treatment protocol with proven long-term efficiency is presented. A randomized clinical trial has been conducted to confirm these results.

Standardized treatment protocols for hypertension: global availability, characteristics, and alignment with the hypertension guideline recommendations.

BACKGROUND: Hypertension control is suboptimal globally. Implementing evidence-based, simple, standardized treatment protocols (STPs) has been instrumental in effectively and efficiently improving treatment and control of hypertension. We aimed to identify, characterize, and critically appraise hypertension STPs. METHODS: We defined STP as a series of steps for the pharmacological treatment of primary hypertension, with information on target population, BP threshold for treatment initiation, target BP, specific drugs/classes/doses, and follow-up frequency. STPs for adult patients were identified from the websites of relevant health organizations, Google search, and through expert consultations (until July 2023). STPs for secondary, gestational, or malignant hypertension or those that were templates/samples were excluded. Included STPs were critically appraised using HEARTS in the Americas Checklist for hypertension management in primary care and compared with the 2021 WHO hypertension management guideline recommendations. RESULTS: Fifty STPs were identified. All STPs had a stepwise treatment approach, involved guideline-recommended first-line drugs, and 98% consisted of at least four steps. Majority (54%) recommended monotherapy with calcium channel blockers as first-line treatment. Only 44% STPs recommended treatment initiation with combination therapy, and 16% recommended single-pill combinations. Most (62%) had dose-intensification as the second step. Most (74%) STPs did not provide complete dosing information. Only one STP mentioned a target time for achieving BP control. On average, STPs scored a performance of 68% on the HEARTS Checklist. CONCLUSION: Several STPs are available globally; however, most of them have enormous scope for improvement through interventions aimed at alignment with the latest evidence-based guidelines and multistakeholder engagement.

Effect of the enhanced recovery protocol in patients with brain tumors undergoing elective craniotomies: a systematic review and meta-analysis.

OBJECTIVE: Enhanced recovery after surgery, or the enhanced recovery protocol (ERP), introduces a contemporary concept for perioperative care within neurosurgery. In recent years, mounting evidence has highlighted the significant impact of this approach on brain tumor surgery. The authors conducted a systematic review and meta-analysis of current publications, with a primary focus on assessing the efficiency and safety of implementing ERP in the management of patients undergoing elective craniotomies for brain tumor resection. METHODS: This study followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines and was registered in the PROSPERO database. A comprehensive search of the MEDLINE, Cochrane, Scopus, and Embase databases was performed, and two independent reviewers extracted the data, assessed bias, and resolved disagreements through discussion. Primary outcomes included hospital length of stay (LOS) and hospitalization cost. The secondary outcomes were complications, including death, reoperation, readmission, intracerebral hemorrhage, CNS infection, and deep vein thrombosis. A random-effects model was used to evaluate the effects of implementing the ERP using the mean difference (MD) for primary outcomes. Heterogeneity was assessed using I2 statistics, and statistical significance was defined as p < 0.05. RESULTS: Eight studies, including 3 randomized controlled trials, 3 prospective studies, and 2 retrospective studies, were included in this meta-analysis. The ERP group had significantly shorter LOS (MD -2.69, 95% CI -3.65 to -1.73; p < 0.00001, I2 = 87%) and lower hospitalization cost (MD -$1188 [US dollars] 95% CI -$1726 to -$650; p = 0.0008, I2 = 71%) than the non-ERP group. There were no significant differences in the incidence of perioperative complications between the two groups. CONCLUSIONS: This study demonstrated the effectiveness of the ERP in improving postoperative outcomes for patients undergoing elective craniotomies for brain tumors. This protocol has demonstrated the ability to reduce hospital stays and costs while maintaining a low complication rate. However, the study acknowledges the presence of clinical and statistical heterogeneity among the included articles, limiting the scope of its conclusions. Further high-quality comparative studies are necessary to substantiate these findings and establish their reliability.

Aprendizaje en investigación clínica: experiencia de enseñanza híbrida con estudiantes de medicina / Learning in Clinical Research: Hybrid Teaching Experience with Medical Students

Introducción: la pandemia de COVID-19 indujo un cambio en nuestro sistema de salud y de educación. Los programas formativos también tuvieron que adaptarse y exigieron un cambio rápido. Objetivos: describir una experiencia educativa de enseñanza virtual/híbrida en investigación clínica, entre docentes del Servicio de Clínica de un hospital universitario y estudiantes de Medicina de una institución privada, que participaron del Programa ESIN (EStudiantes en INvestigación). Metodología: los contenidos y las estrategias educativas incluyeron las clases teóricas audiograbadas o videograbadas (asincrónicas y autoadministradas), el aprendizaje basado en proyectos, los talleres prácticos (encuentros sincrónicos virtuales y grupales), mediante la adopción de modelos de aprendizaje como el aula invertida, y la tutoría individual entre docente-estudiante. Los datos se recopilaron mediante la observación en contextos académicos, y basándonos en elementos de encuestas anónimas de satisfacción, previo consentimiento informado de los participantes. Resultados: participaron 14 estudiantes, 6 durante el año 2021 y 8 durante 2022. Todas mujeres y estudiantes de medicina (50% de cuarto año, 35% de sexto año y 15% de quinto año). Las técnicas implementadas favorecieron la participación y promovieron el aprendizaje activo, basado en proyectos. Mencionaron aspectos positivos como el enfoque académico práctico, la disponibilidad del equipo docente para atender cualquier duda, el tiempo y el entusiasmo por enseñar y fomentar la participación. Los videos teóricos resultaron útiles como herramientas de repaso, y los encuentros grupales fueron especialmente valorados, si bien los encuentros individuales fueron destacados como ayuda y apoyo previo a los congresos científicos. En general, manifestaron que fue una experiencia enriquecedora que demostró que se puede lograr lo que se creía imposible. Todas participaron activamente de al menos un congreso científico, y el 50% resultó coautora de una publicación académica. Conclusión: los estudiantes asumieron compromisos y responsabilidades, e incorporaron competencias y habilidades en la implementación y en la difusión de los proyectos. Esta experiencia educativa facilitó que el tiempo de clase pudiera optimizarse para intercambio, discusión y dudas. Los recursos producidos, las actividades desarrolladas y los contenidos abordados quedan disponibles a nivel institución. (AU)

Introduction: the COVID-19 pandemic brought about a change in our health and education system. Training programs also had to adapt and required rapid change. Objectives: to describe an educational experience of virtual/hybrid teaching in clinical research between teachers of the Clinical Service of a university hospital and medical students of a private institution who participated in the ESIN Program (Students in Research). Methodology: the contents and educational strategies included audio or videotaped lectures (asynchronous and self-administered), project-based learning, practical workshops (virtual and group synchronous meetings) by adopting learning models such as the inverted classroom, and individual tutoring between teacher and student. We gathered the data through observation in academic contexts and based on elements of anonymous satisfaction surveys, with prior informed consent of participants. Results: fourteen students participated, six in 2021 and eight in 2022. All were women and medical students (50% fourth year, 35% sixth year, and 15% fifth year). The techniques implemented favored participation and promoted active, project-based learning. They mentioned positive aspects such as the practical academic approach, the availability of the teaching team for any doubts, the time and enthusiasm for teaching, and encouraging participation. The theory videos were a valuable review tool, and team meetings received high praise even if the one-on-one meetings received much attention as help and support before the scientific congresses. In general, they stated that it was an enriching experience that showed that you can achieve what you thought impossible. All of them actively participated in at least one scientific congress, and 50% were co-authors of an academic publication. Conclusion: the students assumed commitments and responsibilities and incorporated competencies and skills in project implementation and dissemination. This educational experience helped to optimize class time for exchange, discussion, and doubts. The resources produced, the activities developed, and the contents addressed are now available at the institutional level. (AU)

Elaboración e implementación de un protocolo para la Hora Dorada de recién nacidos prematuros utilizando ciencia de la implementación / Elaboration and implementation of a protocol for the Golden Hour of premature newborns using an Implementation Science lens / Elaboração e implementação de protocolo para Hora Ouro do recém-nascido prematuro utilizando ciência da implementação

Objetivo: describir el proceso de diseño e implementación de un protocolo de atención para la primera hora de vida del recién nacido prematuro. Método: investigación participativa, que utilizó el marco de la ciencia de la implementación y los dominios del Consolidated Framework for Implementation Research. Estudio realizado en un hospital escuela del sureste de Brasil, con la participación del equipo multidisciplinario y de los gestores. El estudio se organizó en seis etapas, mediante del ciclo de mejora continua (Plan, Do, Check, Act): diagnóstico situacional; elaboración del protocolo; capacitaciones; implementación del protocolo; relevamiento de barreras y facilitadores; seguimiento y revisión del protocolo. Los datos fueron analizados mediante estadística descriptiva y análisis de contenido. Resultados: el primer protocolo de la Hora Dorada de la institución fue organizado por el equipo multidisciplinario a partir de un enfoque colectivo y dialógico. El protocolo priorizó la estabilidad cardiorrespiratoria, la prevención de hipotermia, hipoglucemia e infección. Después de cuatro meses de capacitación e implementación, el protocolo fue evaluado como una intervención de calidad, necesaria para el servicio, de bajo costo y de poca complejidad. La principal sugerencia de mejora fue realizar actividades educativas frecuentes. Conclusión: la implementación generó cambios e inició un proceso de mejora de la calidad de la atención neonatal, es necesario que la capacitación sea continua para lograr mayor adherencia y mejores resultados.

Objective: describe the process of designing and implementing a care protocol for the first hour of life of premature newborns. Method: a participatory research study using an implementation science framework, the Consolidated Framework for Implementation Research (CFIR) was employed to determine drivers and facilitators of implementation success of the Golden Hour protocol for newborns at a large university hospital in southeastern Brazil. A multi-professional team, including first line providers and managers participated in six stages of quality improvement: situational diagnosis; protocol elaboration; training protocol implementation; barrier and facilitator assessment; and protocol monitoring and review. Qualitative and monitoring data collected across these six stages were analyzed using descriptive statistics and content analysis. Results: the institution's Golden Hour protocol was organized by the multi-professional team based on a collective and dialogical approach. The protocol prioritized the infant's cardiopulmonary stability, as well as prevention of hypothermia, hypoglycemia and infection. After four months of implementation, the care team was evaluated the protocol as a good quality intervention, necessary for the service, low-cost and not very complex. One suggested improvement recommended was to carry out refresher training to address staff turnover. Conclusion: implementation of the Golden Hour protocol introduced an appropriate and feasible neonatal care quality improvement process, which requires periodic refresher training to ensure greater adherence and better neonatal results.

Objetivo: descrever o processo de elaboração e implementação de protocolo assistencial para a primeira hora de vida do recém-nascido prematuro. Método: pesquisa participativa, que utilizou referencial da ciência da implementação e os domínios do Consolidated Framework for Implementation Research. Estudo realizado em hospital universitário no sudeste do Brasil, com participação da equipe multiprofissional e gestores. O estudo foi organizado em seis etapas, por meio do ciclo de melhoria contínua (Plan, Do, Check, Act): diagnóstico situacional; elaboração do protocolo; treinamentos; implementação do protocolo; levantamento de barreiras e facilitadores; monitoramento e revisão do protocolo. Os dados foram analisados por estatística descritiva e análise de conteúdo. Resultados: o primeiro protocolo Hora Ouro da instituição foi organizado pela equipe multiprofissional a partir de uma abordagem coletiva e dialógica. O protocolo priorizou a estabilidade cardiorrespiratória, prevenção de hipotermia, de hipoglicemia e de infecção. Após treinamento e implementação por quatro meses, o protocolo foi avaliado como uma intervenção de qualidade, necessária ao serviço, de baixo custo e pouco complexa. A principal sugestão de melhoria foi realizar ações educativas frequentes. Conclusão: a implementação provocou mudanças e iniciou um processo de melhoria da qualidade da assistência neonatal, sendo necessária a manutenção dos treinamentos para maior adesão e melhores resultados.

Protocolo de intervenções nutricionais para o manejo da obesidade infantil na Atenção Primária à Saúde / Protocol to implement nutritional interventions for the management of childhood obesity in Primary Health Care

Objetivo: Construir e validar um protocolo de intervenções nutricionais para o manejo da obesidade infantil no âmbito da Atenção Primária à Saúde. Métodos: Trata-se de um estudo metodológico, organizado em três fases: elaboração de uma revisão sistemática do tipo overview, com uso das recomendações PRISMA, construção do protocolo clínico e validação do conteúdo com uso dos instrumentos AGREE II e AGREE-REX. Resultados: Foram incluídos 17 estudos para a construção do protocolo, indicando efetividade em intervenções com desfechos na redução significativa do IMC, mudança no comportamento e hábitos alimentares, aumento no nível de conhecimento sobre alimentação saudável. A avaliação do protocolo clínico obteve uma pontuação >70% e, conforme o parâmetro utilizado (≥50% qualidade alta), foi considerado adequado para implementação no campo da saúde da criança, mais especificamente no manejo da obesidade infantil. Conclusão: Um protocolo assistencial para o manejo da obesidade infantil no âmbito da Atenção Primária à Saúde representa de forma positiva uma estratégia sustentável e flexível com atuação de diversos atores sociais como profissionais da saúde e familiares, dentre outros, contribuindo para a redução de riscos de comorbidades associadas à obesidade e custos de saúde, bem como para promover comportamentos mais saudáveis na população pediátrica. Descritores: Atenção Primária à Saúde; Obesidade Infantil; Manejo da Obesidade; Protocolos Clínicos.

Objective: To create and validate a protocol to implement nutritional interventions for the management of childhood obesity in the Primary Health Care scope.Methods: This is a methodological study organized into three phases: elaboration of a systematic review of the "overview" type using the PRISMA recommendations; preparation of the clinical protocol; and content validation using the AGREE II and AGREE-REX instruments.Results: A total of 17 studies were included to create the protocol, indicating effectiveness in interventions with outcomes in a significant BMI reduction, change in eating behaviors and habits, and increase in the knowledge level about healthy eating. The clinical protocol assessment obtained a score >70% and, according to the parameter used (≥50% high quality), it was considered adequate for implementation in the children's health field, more specifically in the management of childhood obesity.Conclusion: A care protocol for the management of childhood obesity in the Primary Health Care scope positively represents a sustainable and flexible strategy with performance of several social actors such as health professionals and family members, among others, contributing to reducing risks of comorbidities associated with obesity and health costs, as well as to promoting healthier behaviors in the pediatric population. Descriptors: Primary Health Care; Pediatric Obesity; Obesity Management; Clinical Protocols.