Objective Improvement After Frenotomy for Posterior Tongue-Tie: A Prospective Randomized Trial

2021 ◽  
pp. 019459982110397
Author(s):  
Bobak A. Ghaheri ◽  
Douglas Lincoln ◽  
Tuyet Nhi T. Mai ◽  
Jess C. Mace
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Bottle Feeding ◽  
Control Group ◽  
Feeding System ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
Patient Reported ◽  
Interventional Group ◽  
Posterior Tongue

Objective Infants with posterior tongue-tie (PTT) can have substantial difficulty with breastfeeding and bottle-feeding. This study aimed to address the dearth in investigational objective data surrounding PTT release to better quantify the postoperative impacts of frenotomy for ankyloglossia. Study Design Prospective randomized, controlled trial. Setting Private practice clinic. Methods In a prospective, randomized controlled trial, infants 3 to 16 weeks of age with PTT undergoing frenotomy were examined using a bottle-feeding system capable of objectively measuring tongue function. Validated patient-reported outcome measures were also obtained simultaneously. Results Forty-seven infants with PTT were enrolled into an observational/control arm (n = 23) or interventional/surgical treatment arm (n = 24). The total cohort consisted of 29 (61.7%) male infants with a median age of 39 days. At the day 10 time point, the interventional arm demonstrated statistically significant improvement in 11 objectively obtained feeding metrics, indicating faster tongue speed, more rhythmic and coordinated sucking motions, and a tongue more capable of adapting to varying feeding demands. Significant improvement in breastfeeding self-efficacy was reported in the interventional group while poor self-confidence persisted in the observational group. Infant reflux symptoms improved in the interventional group while not in the control group. Nipple pain also persisted in the control group but improved in the surgical cohort. Conclusions When measured 10 days after frenotomy for PTT, infants improve feeding parameters using an objective bottle-feeding system. Similar improvements are seen with patient-reported outcomes when PTT is released. Posterior tongue-tie is a valid clinical concern, and surgical release can improve infant and maternal symptoms.

scholarly journals Treatment of osteoarthritis with autologous, micro-fragmented adipose tissue: a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Rasmus Kramer Mikkelsen ◽  
Lars Blønd ◽  
Lisbeth Rosenkrantz Hölmich ◽  
Cecilie Mølgaard ◽  
Anders Troelsen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adipose Tissue ◽  
Knee Injury ◽  
Primary Outcome ◽  
Morphological Changes ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Outcome Score ◽  
Patient Reported

Abstract Background Osteoarthritis is a destructive joint disease that leads to degeneration of cartilage and other morphological changes in the joint. No medical treatment currently exists that can reverse these morphological changes. Intra-articular injection with autologous, micro-fragmented adipose tissue has been suggested to relieve symptoms. Methods/Design The study is a blinded randomized controlled trial with patients allocated in a 1:1 ratio to 2 parallel groups. Patients suffering from pain and functional impairment due to osteoarthritis Kellgren-Lawrence grades 2–3 in the tibiofemoral joint are eligible for inclusion. The intervention group is treated with an intra-articular injection with autologous, micro-fragmented adipose tissue prepared using the Lipogems® system. The control group receives an intra-articular injection with isotonic saline. In total, 120 patients are to be included. The primary outcome is The Knee injury and Osteoarthritis Outcome Score (KOOS4) evaluated at 6 months. Secondary outcomes are KOOS at 3, 12 and 24 months; the Tegner activity score; treatment failure; and work status of the patient. The analysis will be conducted both as intention-to-treat and per-protocol analysis. Discussion This trial is the first to investigate the efficacy of autologous, micro-fragmented adipose tissue in a randomized controlled trial. The study uses the patient-reported outcome measure Knee Injury and Osteoarthritis Outcome Score (KOOS4) after 6 months as the primary outcome, as it is believed to be a valid measure to assess the patient’s opinion about their knee and associated problems when suffering from osteoarthritis.

scholarly journals Rapid Intervention of Chlorpromazine and Promethazine for Hibernation-Like Effect in Stroke: Rationale, Design, and Protocol for a Prospective Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Shuyu Lv ◽  
Wenbo Zhao ◽  
Gary B. Rajah ◽  
Chaitu Dandu ◽  
Lipeng Cai ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Intravenous Administration ◽  
Neuroprotective Effect ◽  
Controlled Trial ◽  
Intervention Group ◽  
Intravenous Thrombolysis ◽  
Control Group ◽  
Short Treatment ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial

Background: Following an acute ischemic stroke (AIS), rapidly initiated reperfusion therapies [i. e., intravenous thrombolysis (IVT) and endovascular treatment (EVT)] demonstrate robust clinical efficacy. However, only a subset of these patients can benefit from these therapies due to their short treatment windows and potential complications. In addition, many patients despite successful reperfusion still have unfavorable outcomes. Thus, neuroprotection strategies are urgently needed for AIS patients. Chlorpromazine and promethazine (C+P) have been employed in clinical practice for antipsychotic and sedative purposes. A clinical study has also shown a neuroprotective effect of C+P on patients with cerebral hemorrhage and subarachnoid hemorrhage. The safety, feasibility, and preliminary efficacy of intravenous administration of C+P in AIS patients within 24 h of onset will be elucidated.Methods: A prospective randomized controlled trial is proposed with AIS patients. Participants will be randomly allocated to an intervention group and a control group with a 1:1 ratio (n = 30) and will be treated with standard therapies according to the current stroke guidelines. Participants allocated to the intervention group will receive intravenous administration of C+P (chlorpromazine 50 mg and promethazine 50 mg) within 24 h of symptom onset. The primary outcome is safety (mainly hypotension), while the secondary outcomes include changes in functional outcome and infarction volume.Discussions: This study on Rapid Intervention of Chlorpromazine and Promethazine for Hibernation-like Effect in Stroke (RICHES) will be the first prospective randomized controlled trial to ascertain the safety, feasibility, and preliminary efficacy of intravenous C+P as a neuroprotection strategy in AIS patients. These results will provide parameters for future studies, provide insights into treatment effects, and neuroprotection with phenothiazine in AIS.Clinical Trial Registration:www.chictr.org.cn, identifier: ChiCTR2000038727.

Early outcomes of primary total hip arthroplasty with use of a smartphone-based care platform: a prospective randomized controlled trial

2021 ◽  
Vol 103-B (7 Supple B) ◽  
pp. 91-97 ◽  
Author(s):  
David A. Crawford ◽  
Adolph V. Lombardi ◽  
Keith R. Berend ◽  
James I. Huddleston ◽  
Christopher L. Peters ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Treatment Group ◽  
Total Hip Arthroplasty ◽  
Hip Arthroplasty ◽  
Care Management ◽  
Controlled Trial ◽  
Urgent Care ◽  
Control Group ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial

Aims The purpose of this study is to evaluate early outcomes with the use of a smartphone-based exercise and educational care management system after total hip arthroplasty (THA) and demonstrate decreased use of in-person physiotherapy (PT). Methods A multicentre, prospective randomized controlled trial was conducted to evaluate a smartphone-based care platform for primary THA. Patients randomized to the control group (198) received the institution’s standard of care. Those randomized to the treatment group (167) were provided with a smartwatch and smartphone application. PT use, THA complications, readmissions, emergency department/urgent care visits, and physician office visits were evaluated. Outcome scores include the Hip disability and Osteoarthritis Outcome Score (HOOS, JR), health-related quality-of-life EuroQol five-dimension five-level score (EQ-5D-5L), single leg stance (SLS) test, and the Timed Up and Go (TUG) test. Results The control group was significantly younger by a mean 3.0 years (SD 9.8 for control, 10.4 for treatment group; p = 0.007), but there were no significant differences between groups in BMI, sex, or preoperative diagnosis. Postoperative PT use was significantly lower in the treatment group (34%) than in the control group (55.4%; p = 0.001). There were no statistically significant differences in complications, readmissions, or outpatient visits. The 90-day outcomes showed no significant differences in mean hip flexion between controls (101° (SD 10.8)) and treatment (100° (SD 11.3); p = 0.507) groups. The HOOS, JR scores were not significantly different between control group (73 points (SD 13.8)) and treatment group (73.6 points (SD 13); p = 0.660). Mean 30-day SLS time was 22.9 seconds (SD 19.8) in the control group and 20.7 seconds (SD 19.5) in the treatment group (p = 0.342). Mean TUG time was 11.8 seconds (SD 5.1) for the control group and 11.9 (SD 5) seconds for the treatment group (p = 0.859). Conclusion The use of the smartphone care management system demonstrated similar early outcomes to those achieved using traditional care models, along with a significant decrease in PT use. Noninferiority was demonstrated with regard to complications, readmissions, and ED and urgent care visits. This technology allows patients to rehabilitate on a more flexible schedule and avoid unnecessary healthcare visits, as well as potentially reducing overall healthcare costs. Cite this article: Bone Joint J 2021;103-B(7 Supple B):91–97.

scholarly journals Evaluating the use of the EORTC patient-reported outcome measures for improving inter-rater reliability of CTCAE ratings in a mixed population of cancer patients: study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Lisa M. Wintner ◽  
◽  
Johannes M. Giesinger ◽  
Monika Sztankay ◽  
Andrew Bottomley ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Adverse Event ◽  
Adverse Events ◽  
Controlled Trial ◽  
Control Group ◽  
Rater Reliability ◽  
Randomized Controlled ◽  
Patient Reported ◽  
The Impact

Abstract Background In oncology, detection and tracking of adverse events are of top priority and rely mostly on the Common Terminology Criteria for Adverse Events (CTCAE). Besides, clinical trials use as well patient-reported outcomes (PROs) to assess those adverse events, which are only accessible through patient self-reporting, such as fatigue, pain, and sleep disorders. Especially those issues that are not visible from the outside are often misinterpreted and underestimated by mere provider ratings. This trial aims at evaluating the impact of providing PRO data to providers on the accuracy of adverse event assessment in terms of inter-rater reliability of CTCAE ratings. Methods The trial uses a cross-sectional, unblinded, randomized controlled trial design with two trial arms and a single assessment time point. Eligible patients (aged 18 and above, any cancer diagnosis, currently under treatment, inpatient or day clinic setting, present symptom burden, no psychiatric or mental problems, written informed consent) complete an electronic version of the EORTC QLQ-C30 and 16 additional questions taken from the EORTC Item Library. PRO data is immediately processed and made available to CTCAE rating providers for conducting their ratings during the medical encounter. Patients are randomly assigned 1:1 to the intervention group (providers see PRO results on the same screen as the CTCAE rating) and the control group (no access to PRO data during the CTCAE rating). A superiority analysis will compare the inter-rater reliability (using intra-class correlation (ICC) coefficients) between the control and the intervention groups for each adverse event evaluated. Discussion The presented trial will demonstrate potential benefits of using PRO measures to improve the reliability of CTCAE ratings in cancer trials and the identification of adverse events. The new insights gained may lead to a new strategy for evaluating adverse events in clinical trials by combining patient and provider ratings. This might also have implications for daily clinical practice and cancer registries. Trial registration ClinicalTrials.gov NCT04066868. Registered on August 26, 2019. Competence Center for Clinical Trials of the Medical University of Innsbruck 20190513-2007. Registered on May 14, 2019. (version 6.0, March 18, 2019)

scholarly journals A Brief Mindfulness-Based Intervention for Primary Care Physicians: A Pilot Randomized Controlled Trial

2016 ◽  
Vol 12 (1) ◽  
pp. 83-91 ◽  
Author(s):  
David A. Schroeder ◽  
Elizabeth Stephens ◽  
Dharmakaya Colgan ◽  
Matthew Hunsinger ◽  
Dan Rubin ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Primary Care Physicians ◽  
Controlled Trial ◽  
Well Being ◽  
Control Group ◽  
Randomized Controlled ◽  
Patient Reported ◽  
The Impact

Primary care physicians experience high rates of burnout, which results in diminished quality of life, poorer quality of care, and workforce attrition. In this randomized controlled trial, our primary aim was to examine the impact of a brief mindfulness-based intervention (MBI) on burnout, stress, mindfulness, compassion, and resilience among physicians. A total of 33 physicians completed the baseline assessment and were randomized to the Mindful Medicine Curriculum (MMC; n = 17) or waitlist control group (n = 16). Participants completed self-report measures at baseline, post-MBI, and 3-month follow-up. We also analyzed satisfaction with doctor communication (DCC) and overall doctor rating (ODR) data from patients of the physicians in our sample. Participants in the MMC group reported significant improvements in stress (P < .001), mindfulness (P = .05), emotional exhaustion (P = .004), and depersonalization (P = .01) whereas in the control group, there were no improvements on these outcomes. Although the MMC had no impact on patient-reported DCC or ODR, among the entire sample at baseline, DCC and ODR were significantly correlated with several physician outcomes, including resilience and personal achievement. Overall, these findings suggest that a brief MBI can have a positive impact on physician well-being and potentially enhance patient care.

scholarly journals High-Intensity Interval Training for Heart Failure Patients With Preserved Ejection Fraction (HIT-HF)-Rational and Design of a Prospective, Randomized, Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Benedikt A. Gasser ◽  
Maria Boesing ◽  
Raphael Schoch ◽  
Stefanie Brighenti-Zogg ◽  
Julia M. Kröpfl ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Ejection Fraction ◽  
Exercise Capacity ◽  
Controlled Trial ◽  
Control Group ◽  
Preserved Ejection Fraction ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial ◽  
High Intensity Interval ◽  
Disease Specific

Background: The pathophysiology of HF with preserved ejection fraction (HFpEF) has not yet been fully understood and HFpEF is often misdiagnosed. Remodeling and fibrosis stimulated by inflammation appear to be main factors for the progression of HFpEF. In contrast to patients with HF with reduced ejection fraction, medical treatment in HFpEF is limited to relieving HF symptoms. Since mortality in HFpEF patients remains unacceptably high with a 5-year survival rate of only 30%, new treatment strategies are urgently needed. Exercise seems to be a valid option. However, the optimal training regime still has to be elucidated. Therefore, the aim of the study is to investigate the effects of a high-intensity interval (HIT) training vs. a moderate continuous training (MCT) on exercise capacity and disease-specific mechanisms in a cohort of patients with HFpEF.Methods: The proposed study will be a prospective, randomized controlled trial in a primary care setting including 86 patients with stable HFpEF. Patients will undergo measurements of exercise capacity, disease-specific blood biomarkers, cardiac and arterial vessel structure and function, total hemoglobin mass, metabolic requirements, habitual physical activity, and quality of life (QoL) at baseline and follow-up. After the baseline visit, patients will be randomized to the intervention or control group. The intervention group (n = 43) will attend a supervised 12-week HIT on a bicycle ergometer combined with strength training. The control group (n = 43) will receive an isocaloric supervised MCT combined with strength training. After 12 weeks, study measurements will be repeated in all patients to quantify the effects of the intervention. In addition, telephone interviews will be performed at 6 months, 1, 2, and 3 years after the last visit to assess clinical outcomes and QoL.Discussion: We anticipate clinically significant changes in exercise capacity, expressed as VO2peak, as well as in disease-specific mechanisms following HIT compared to MCT. Moreover, the study is expected to add important knowledge on the pathophysiology of HFpEF and the clinical benefits of a training intervention as a novel treatment strategy in HFpEF patients, which may help to improve both QoL and functional status in affected patients.Trial registration:ClinicalTrials.gov, identifier: NCT03184311, Registered 9 June 2017.

scholarly journals Preventing Adverse Events of Chemotherapy for Gastrointestinal Cancer by Educating Patients about the Nocebo Effect: A Randomized-controlled Trial

2021 ◽  
Author(s):  
Twyla L. Michnevich ◽  
Yiqi Pan ◽  
Armin Hendi ◽  
Karin Oechsle ◽  
Alexander Stein ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Adverse Events ◽  
Gastrointestinal Cancer ◽  
Controlled Trial ◽  
Mean Difference ◽  
Control Group ◽  
Nocebo Effect ◽  
Randomized Controlled ◽  
Education Group ◽  
Patient Reported

Abstract Background: Adverse events of chemotherapy may be caused by pharmacodynamics or psychological factors such as negative expectations, which constitute nocebo effects. In a randomized controlled trial, we examined whether educating patients about the nocebo effect is efficacious in reducing the intensity of self-reported adverse events. Methods: N = 49 and n = 51 patients (mean age: 60.2 years, 65% male, 54% UICC tumour stage IV) with newly-diagnosed gastrointestinal cancer were allocated to a nocebo education and attention control group, respectively.Results: GLM with adjustments for tumour staging and distress indicated that intensity of adverse events differed at 12-weeks after onset of chemotherapy (mean difference: 4.04, 95% CI [0.72, 7.36], p = .02, d = 0.48), with lower levels in the nocebo education group. Of these,). This was attributable to less non-specific adverse events (mean difference: 0.39, 95% CI [0.04, 0.73], p = .03, d = 0.44) and a trend towards less specific adverse events in the nocebo education group (mean difference: 0.36, 95% CI [-0.02, 0.74], p = .07, d = 0.37). We found no difference in adverse events at 10-days follow-up, perceived control of adverse events, or tendency to misattribute non-specific symptoms to the chemotherapy. Conclusions: This study provides first proof-of-concept evidence for the efficacy of a brief information session in preventing adverse events of chemotherapy. However, results regarding patient-reported outcomes cannot rule out response biases. Informing patients about the nocebo effect may be an innovative and clinically feasible intervention for reducing the burden of adverse events.Trial registration: retrospectively registered on March 27, 2018 to the German Clinical Trial Register (ID: DRKS00009501).

scholarly journals Preemptive Treatment of Nausea and Vomiting of Pregnancy: Results of a Randomized Controlled Trial

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Caroline Maltepe ◽  
Gideon Koren
Keyword(s):  
Randomized Controlled Trial ◽  
High Risk ◽  
Controlled Trial ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Preemptive Therapy ◽  
Previous Pregnancy ◽  
Preemptive Treatment ◽  
Randomized Controlled ◽  
Prospective Randomized Controlled Trial

Objectives. To determine whether the initiation of treatment (preemptive treatment) before the symptoms of nausea and vomiting of pregnancy (NVP) versus when the symptoms begin can improve the outcome in patients at a high risk for recurrence of severe NVP.Study Design. Prospective, randomized controlled trial.Results. Preemptive therapy conferred a significant reduction in HG as compared to the previous pregnancy (P=0.047). In the preemptive arm, there were 2.5-fold fewer cases of moderate-severe cases of NVP than those in the control group (15.4% versus 39.13%) in the first 3 weeks of NVP (P=0.05). In the preemptive group, significantly more women had their NVP resolved before giving birth (78.2% versus 50%) (P<0.002).Conclusions. Preemptive treatment with antiemetics is superior to the treatment that starts only when the symptoms have already occurred in decreasing the risk of severe forms of NVP.

scholarly journals A novel self-assembling peptide for hemostasis during endoscopic submucosal dissection: a randomized controlled trial

Endoscopy ◽  
2020 ◽  
Vol 53 (01) ◽  
pp. 27-35
Author(s):  
Sharmila Subramaniam ◽  
Kesavan Kandiah ◽  
Fergus Chedgy ◽  
Carole Fogg ◽  
Sreedhari Thayalasekaran ◽  
...  
Keyword(s):  
Wound Healing ◽  
Randomized Controlled Trial ◽  
Endoscopic Submucosal Dissection ◽  
Controlled Trial ◽  
Control Group ◽  
Bleeding Rate ◽  
Delayed Bleeding ◽  
Randomized Controlled ◽  
Heat Therapy ◽  
Interventional Group

Abstract Background Endoscopic submucosal dissection (ESD) is associated with a risk of bleeding. Bleeding is usually treated with diathermy, although this does carry a risk of mucosal thermal injury. Purastat is a topical hemostat that may be effective in controlling bleeding during ESD, thereby reducing the use of heat therapy. The aim of this study was to assess the reduction in heat therapy used in the interventional group (Purastat) compared with the control group. The secondary aims were to compare the procedure length, time for hemostasis, delayed bleeding rate, adverse events, and wound healing between the groups. Methods This was a single-center randomized controlled trial of 101 patients undergoing ESD. Participants were randomized to a control group where diathermy was used to control bleeding or an interventional group where Purastat could be used. Follow-up endoscopy was performed at 4 weeks to assess wound healing. Results There was a significant reduction in the use of heat therapy for intraprocedural hemostasis in the interventional group compared with controls (49.3 % vs. 99.6 %, P < 0.001). There were no significant differences in the procedure length, time for hemostasis, and delayed bleeding rate between the groups. Complete wound healing at 4 weeks was noted in 48.8 % of patients in the interventional group compared with 25.0 % of controls (P = 0.02). Conclusions This study has demonstrated that Purastat is an effective hemostat that can reduce the need for heat therapy for bleeding during ESD. It may also have a role in improving post-resection wound healing.

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