Prospective Controlled Pilot Study Research Articles

Effectiveness of vaginal probiotics Lactobacillus crispatus chen-01 in women with high-risk HPV infection: a prospective controlled pilot study.

Female genital tract infection with high-risk human papilloma virus (HR-HPV) has the risk of developing into cervical cancer, and there is still a lack of effective therapeutic strategies. Probiotic intervention is considered as a potential intervention for HR-HPV, while exploration into living probiotic preparations for specific diseases remains limited and insufficient. This prospective controlled pilot study was conducted to observe the effect of intravaginal transplantation of a vaginal isolated natural probiotic strain, Lactobacillus crispatus chen-01, on the clearance of high-risk HPV infection. 100 women with high-risk HPV infection were enrolled and randomly divided into placebo group and probiotic treatment group, which received intravaginal transplantation of L. crispatus chen-01. Cervical exfoliated cells were collected 6 months later for detecting DNA load, typing of HPV, and cytological analysis. Our results showed that vaginal transplantation with L. crispatus chen-01 significantly reduced viral load of HPV, ameliorated HPV clearance rate, and improved vaginal inflammation state without causing obvious adverse reactions. Analysis of 16S rRNA sequencing revealed that L. crispatus chen-01 could effectively reconstitute the vaginal microbiota in women with high-risk HPV, which might be one of the underlying mechanisms of the beneficial effect of L. crispatus chen-01 transplantation. Our results suggested that vaginal transplantation of L. crispatus chen-01 might be a promising treatment for patients with high-risk HPV infection.

High dose cholecalciferol supplementation causing morning blood pressure reduction in patients with type 1 diabetes mellitus and cardiovascular autonomic neuropathy

We evaluated the association of cardiovascular autonomic neuropathy (CAN), blood pressure (BP) and Vitamin D (VD) levels before and after high-dose cholecalciferol supplementation (4000/10,000) UI/day) for 12 weeks in patients (N = 67) with type 1 diabetes mellitus (T1DM). Based on this prospective controlled pilot study, patients were divided into group 1 (N = 23 with CAN) and group 2 (N = 44 without CAN). At baseline, group 1 had higher systolic BP (SBP) during sleep (115 ± 14 vs. 107 ± 12 mmHg, p = 0.04) and lower nocturnal dipping (3 ± 5 vs. 8 ± 6%, p = 0.009). Among those with loss of nocturnal dipping, 45.4% (20/44) had CAN, while in normal nocturnal dipping group it occurred only in 13% (3/23) (p = 0.007). Non-dipper group had worse CAN parameters when compared to dipper group [Very low frequency (VLF) (2.5 ± 0.5vs.2.8 ± 0.4 s, p = 0.01), total power (TP) (2.9 ± 0.6 vs. 3.3 ± 0.4 s, p = 0.01), Valsalva coefficient (1.5 ± 0.4 vs. 1.8 ± 0.6, p = 0.06)]. After VD, only group 1 improved CAN parameters [TP (2.5 ± 0.4 vs. 2.8 ± 0.6, p = 0.01) and VLF (2.2 ± 0.4 vs. 2.4 ± 0.5, p = 0.03). Group 1 presented a reduction in morning SBP (120 ± 20 vs. 114 ± 17 mmHg, p = 0.038) and in morning SBP surge (13 ± 13 vs. 5 ± 14, p = 0.04). High-dose VD was associated with improved CAN parameters and reduced awake SBP and morning SBP surge. These findings suggest that VD may benefit patients with cardiovascular autonomic neuropathy. ISRCTN32601947, registration date: 31/07/2017.

Efficacy of a low dose of antivenom for severe neuroparalysis in Bungarus caeruleus (common krait) envenomation: a pilot study.

Despite the widespread use of antivenom for the treatment of snakebite envenoming in the Indian subcontinent, the ideal dose of antivenom has been a point of contention. Low-dose regimens can economize on a scarce resource in low- and middle-income countries. This study assessed the effectiveness of a low-dose (10 vials) antivenom regimen compared to the usual 20 vials in patients with krait bite neuroparalysis requiring mechanical ventilation. This study was a prospective controlled pilot study conducted in a tertiary-care hospital in north India. Participants were eligible if they were ≥12years old, had krait bite neurotoxicity, showed severe paralysis requiring mechanical ventilation, and had access to antivenom therapy within 24h of the bite. The primary outcome was the duration of mechanical ventilation, and the secondary outcomes were the length of hospital stay and in-hospital survival. Fifteen patients received 10 vials of antivenom, and 25 received 20 vials. The two treatment groups had similar baseline demographics, clinical and laboratory features, snakebite severity scores, and median time from snakebite to initiation of antivenom therapy. The low-dose regimen was as effective as the standard dose concerning the median duration of mechanical ventilation (41h vs. 55h, P=0.094), the median length of stay (78h vs. 85.5h, P=0.360), and in-hospital deaths (1 vs. 3, P=1.000). The incidence of ventilator-associated pneumonia was similar between the two groups (1 vs 3, P=1.000). A low dose of antivenom effectively treats patients with severe krait bite neuroparalysis.

Quality of life amongst patients with diverting umbilical stomas in rectal surgery: a single centre prospective randomized controlled pilot study.

The umbilical stoma (umbistoma) has been proposed as a viable alternative site for a temporary defunctioning stoma. Suggested advantages of the umbistoma include decreased number of surgical incisions required, improved cosmesis and ease of reversal surgery. This study aimed to assess the patient experience of umbilical loop ileostomies in rectal surgery, with the primary outcome being patient reported quality of life (QoL). A total of 20 patients undergoing laparoscopic rectal cancer surgery were randomly allocated to have a defunctioning ileostomy at a conventional site (right iliac fossa) or at the umbilicus. Patient-reported QoL was assessed at 6 weeks using the Stoma-QoL questionnaire. Secondary outcomes were number of stomas reversed, length of time awaiting stoma reversal surgery, duration of operative time for stoma reversal, length of hospital stay following stoma reversal and rate of parastomal or post reversal incisional hernias. Patients who had an umbilical stoma scored significantly lower on the Stoma-QoL questionnaire compared to the conventional group, particularly on questions regarding feelings of tiredness, body insecurity and anxiety. No significant differences were observed between the two groups in relation to secondary outcomes. There may be potential disadvantages to the umbilical stoma with negative impacts on body image and subsequent increased social anxiety. Patient selection and adequate counselling will be important when considering an umbilical stoma. Further larger scale prospective studies are required to further validate the feasibility and longer-term safety of umbilical stomas in both clinical outcomes as well as patient QoL.

Indirect Coagulation of Residual Lesions of Circumferential Piles after Excisional Hemorrhoidectomy; a Prospective Controlled Pilot Study

Indirect Coagulation of Residual Lesions of Circumferential Piles after Excisional Hemorrhoidectomy; a Prospective Controlled Pilot Study

An Augmented Reality-Based Guide for Mechanical Ventilator Setup: Prospective Randomized Pilot Trial.

BackgroundRecently, the demand for mechanical ventilation (MV) has increased with the COVID-19 pandemic; however, the conventional approaches to MV training are resource intensive and require on-site training. Consequently, the need for independent learning platforms with remote assistance in institutions without resources has surged.ObjectiveThis study aimed to determine the feasibility and effectiveness of an augmented reality (AR)–based self-learning platform for novices to set up a ventilator without on-site assistance.MethodsThis prospective randomized controlled pilot study was conducted at Samsung Medical Center, Korea, from January to February 2022. Nurses with no prior experience of MV or AR were enrolled. We randomized the participants into 2 groups: manual and AR groups. Participants in the manual group used a printed manual and made a phone call for assistance, whereas participants in the AR group were guided by AR-based instructions and requested assistance with the head-mounted display. We compared the overall score of the procedure, required level of assistance, and user experience between the groups.ResultsIn total, 30 participants completed the entire procedure with or without remote assistance. Fewer participants requested assistance in the AR group compared to the manual group (7/15, 47.7% vs 14/15, 93.3%; P=.02). The number of steps that required assistance was also lower in the AR group compared to the manual group (n=13 vs n=33; P=.004). The AR group had a higher rating in predeveloped questions for confidence (median 3, IQR 2.50-4.00 vs median 2, IQR 2.00-3.00; P=.01), suitability of method (median 4, IQR 4.00-5.00 vs median 3, IQR 3.00-3.50; P=.01), and whether they intended to recommend AR systems to others (median 4, IQR 3.00-5.00 vs median 3, IQR 2.00-3.00; P=.002).ConclusionsAR-based instructions to set up a mechanical ventilator were feasible for novices who had no prior experience with MV or AR. Additionally, participants in the AR group required less assistance compared with those in the manual group, resulting in higher confidence after training.Trial RegistrationClinicalTrials.gov NCT05446896; https://beta.clinicaltrials.gov/study/NCT05446896

Use of artificial intelligence as a didactic tool to improve ejection fraction assessment in the emergency department: A randomized controlled pilot study.

ObjectivesIncorporating artificial intelligence (AI) into echocardiography operated by clinicians working in the emergency department to accurately assess left‐ventricular ejection fraction (LVEF) may lead to better diagnostic decisions. This randomized controlled pilot study aimed to evaluate AI use as a didactic tool to improve noncardiologist clinicians’ assessment of LVEF from the apical 4‐chamber (A4ch) view.MethodsThis prospective randomized controlled pilot study tested the feasibility and acceptability of the incorporation of AI as a didactic tool by comparing the ability of 16 clinicians who work in the emergency department to assess LVEF before and after the introduction of an AI‐based ultrasound application. Following a brief didactic course, participants were randomly equally divided into an intervention and a control group. In each of the first and second sessions, both groups were shown 10 echocardiography A4ch clips and asked to assess LVEF. Following each clip assessment, only the intervention group was shown the results of the AI‐based tool. For the final session, both groups were presented with a new set of 40 clips and asked to evaluate the LVEF.ResultsIn the “normal‐abnormal” category evaluation, as related to own baseline accuracy assessment, the intervention group had an improvement in accuracy on 50 consecutive clip assessments compared with a decline in the control group (0.10 vs. −0.12, respectively, p = 0.038). In the “significantly reduced LVEF” category, the intervention group showed significantly less decline in clip assessment as compared to the control group (−0.03 vs. −0.12, respectively, p = 0.050).ConclusionsA study involving AI incorporation as a didactic tool for clinicians working in the emergency department appears feasible and acceptable. The introduction of an AI‐based tool to clinicians working in the emergency department improved the assessment accuracy of LVEF as compared to the control group.

Feasibility of simple exercise interventions for men with osteoporosis – A prospective randomized controlled pilot study

BackgroundAging is associated with progressive loss of musculoskeletal performance. Exercise interventions can improve physical function in the elderly but there is a paucity of comparative assessments in order to understand what specific goals can be achieved particularly with less demanding exercise interventions readily accessible for untrained men. MethodsProspective randomized, controlled, single center exploratory trial to compare four distinct exercise interventions, i.e. Resistance Training (RT), Whole Body Vibration Exercise (WBV), Qi Gong (QG) and wearing a Spinal orthosis (SO) for 6 months in men at risk for osteoporosis aged 65–90 years. Primary endpoint was change in isometric one repetition maximum force trunk strength for extension (TSE) and flexion (TSF) compared to baseline, secondary endpoints covered key parameters of geriatric functional assessment, including Handgrip Strength (HS), Chair-Rise-Test (CRT), Usual Gait Speed (UGS) and Timed-Up-and-Go (TUG). ResultsAltogether 47 men (mean age 77 ±6.1 years) were randomized to RT, (n = 11) WBV (n = 13), QG (n = 10) and SO(n = 13). RT, defined as reference exercise intervention, lead to significant improvements for TSE (p = 0.009) and TSF (p = 0.013) and was significantly superior in the between-group analysis for TSE (p = 0.038). Vibration exercise caused sign. Improvements in TSE (p = 0.014) and CRT (p = 0.005), the Spinal orthosis improved CRT (p = 0.003) and Gait Speed (p = 0.027), while the QG intervention did not attain any sig. Developments.Subgroup analyses revealed most pronounced musculoskeletal progress in vulnerable patients (age ≥ 80 years, pre-sarcopenia, multimorbidity ≥3chronic diseases). Irrespective of the type of exercise, participants ≥80 years experienced significant gains in TSE (p = 0.029) and CRT (p = 0.017). Presarcopenic subjects (Skeletal muscle Index (SMI) ≤10.75 kg/m2) improved in TSE (p = 0.003), CRT (p = 0.001) and UGS (p = 0.016). Multimorbid participants achieved sig. Gains in TSE (p < 0.001), TSF (p = 0.002), UGS (p = 0.036) and HS (p = 0.046). ConclusionsIn this exploratory trial we found that simple exercise interventions are feasible in elderly men eliciting specific benefits, i.e. improvements are attained in those tasks addressed with the respective exercise modality. While targeted resistance training is superior in increasing TSE, alternative simple exercise interventions also appear to elicit beneficial effects, even in vulnerable patients, i.e. those with low muscle mass, above 80 years of age or multimorbidity.

A - 26 AMPAR as a Sports Concussion Biomarker and Its Relationship to Neurocognitive Functioning in Collegiate Athletes

Abstract Objective This prospective controlled observational cohort pilot study investigated a potential blood-based biomarker [α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid receptor (AMPAR)] and relationship to neurocognitive testing in collegiate athletes. Methods A multisport sample of 60 collegiate athletes (53% female; 44 contact, 16 non-contact controls) completed ImPACT testing and provided blood samples at a pre-season baseline and within 4 weeks post-season. Plasma and serum samples were processed for AMPAR peptides and antibodies. Twelve athletes did not complete all procedures and were excluded from the final analysis (final n = 48; 36 contact; 12 controls). Results Contact athletes demonstrated greater increases in serum AMPAR antibodies compared to controls (t(46) = 3.24;p &amp;lt; 0.01). On neurocognitive testing, controls had a faster reaction time than contact athletes at baseline (p &amp;lt; 0.05); however, this increased post season (p &amp;lt; 0.01), with the mean change in reaction time (contact: M = 0.06, SD = 0.19; control: M = 0.00, SD = 0.04) approaching significance (t(37.23) = 1.54; p &amp;lt; 0.15). Additionally, ImPACT reaction time was correlated (r = 0.37;p &amp;lt; 0.05) with serum AMPAR antibodies, with slowed reaction time related to increased AMPAR in contact athletes only and only post-season. Conclusions Serum AMPAR antibody levels significantly increased in the contact group and were correlated with reaction time on contact athlete neurocognitive testing at post-season only, with contact athletes showing both slower reaction time and increased levels of AMPAR antibodies compared to controls. No findings were identified in plasma AMPAR peptides, possibly related to sample processing which could not be done immediately in this pilot study. Future research and replication is needed; however, AMPAR may represent a blood-based concussion biomarker, with potential for clinical utility in athletes.

Effects of a 90-min educational intervention for patients with insect venom allergy: a prospective controlled pilot study

BackgroundAnaphylactic sting reactions need a prompt management. A structured educational intervention for patients with insect sting allergy has not been implemented so far. The purpose of this study was to analyze the effects of a structured 90-min educational intervention for patients with insect sting allergy.MethodsPatients with an insect venom allergy were offered to participate in a structured 90-min group education (intervention group (IG)) or to attend a control group (CG). The patients’ subjective self-assurance in using the emergency medication, the willingness to always carry the emergency medication, the mental health status, absolute one-time willingness-to-pay (WTP) for complete cure, a disease knowledge assessment and a simulation test to examine the ability to manage an acute sting reaction were estimated at baseline (t0) and at follow-up (t1) as outcome parameters.Results55 patients participated in the IG (n = 25, 52.0% female, mean age 55.9 years) or the CG (n = 30, 56.7% female, mean age 52.0 years). Both arms showed a significant gain in self-assurance in using the emergency medication (IG: 6.1 at t0 vs. 8.6 at t1, p < 0.0001 and CG: 7.1 vs. 8.0, p = 0.0062) and ability to manage an acute sting reaction (IG: 6.7 vs. 11.4, p < 0.0001 and CG: 9.0 vs. 10.5, p = 0.0002) at t1. However, trained participants showed a significantly higher gain in the respective parameters. There were no significant changes regarding the remaining examined outcome parameters.ConclusionsPatients who are willing to invest 90 min in a patient education intervention benefit significantly by an increased subjective and objective empowerment to manage an acute sting reaction.

P044 A prospective randomised controlled mixed-methods pilot study of home monitoring in adults with cystic fibrosis (HOME-CF)

P044 A prospective randomised controlled mixed-methods pilot study of home monitoring in adults with cystic fibrosis (HOME-CF)

The relationship of Serum Histone H3.3 and H4 with chronic Hepatitis B.

To determine the role of serum histone H3.3 and H4 in patients with chronic hepatitis B to explore any relationship between the two. The prospective controlled clinical pilot study was conducted in the Gastroenterology Clinic of Bezmialem Vakif University, Istanbul, Turkey, from January to October 2017, and comprised biopsy-proven patients with chronic hepatitis B and healthy controls. Demographics, hepatitis B virus deoxyribonucleic acid quantity, hepatitis B e-antigen, aspartate aminotransferase, alanine transaminase, international normalized ratio, total/direct bilirubin, albumin and thrombocyte counts as well as histological activity index and fibrosis scores were noted. Data was analysed using SPSS 22. Of the 140 subjects, 70(50%) each were cases and controls. The overall mean age of the sample was 43.38±15.07 years (range: 18-70 years). There was positive correlation of histone H3.3 with hepatitis B virus deoxyribonucleic acid, aspartate aminotransferase, alanine transaminase and international normalized ratio levels. Histone H4 levels only correlated with hepatitis B virus deoxyribonucleic acid and international normalized ratio. Hepatitis B e-antigen positivity was present in 14(20%) of the cases. Histone H3.3 levels appeared to be associated with pathophysiological changes in chronic hepatitis B patients, suggesting that future treatments should target H3.3.

Analyzing the value of an educational program for psoriasis patients: a prospective controlled pilot study

BackgroundPsoriasis is a chronic inflammatory skin disease associated with a reduced life-quality. Severe disease forms put the patients at risk for life-treating cardiovascular events, metabolic, and other immune-mediated disorders. Psoriasis patients are often not sufficiently informed about their condition leading to suboptimal treatment adherence and, consequently, worse patient outcome. We investigated the value of an educational program on knowledge and self-expertise about the disease in psoriasis patients in general and dependent on age and disease duration.MethodsRegular visit psoriasis-patients were asked to participate and choose to receive an additional educational program or not. Participating patients (n = 53) filled out two questionnaires: one at study inclusion and one at the next regular visit or after the absolved educational program. Surveys included disease knowledge assessment and numeric rating scales (0–10) for self-expertise about the disease, therapy adherence, and therapy satisfaction. The Dermatology Life Quality Index (DLQI) was used to investigate the quality of life.All continuous parameters were examined for statistically significant differences by paired t-test or unpaired t-test. Continuous parameters without Gaussian distribution were analyzed with the Wilcoxon matched pairs test or the Mann-Whitney test. For all categorical parameters, Fisher’s exact test was used.ResultsPatients who chose to be educated (n = 24) showed a significant increase in knowledge, self-expertise about the disease and amelioration of general health. No positive short-term effects were seen on the quality of life and therapy adherence. Analyzing the effect of age and disease duration, the educational program led to significant improvement of the emotional well-being in older patients (≥50 years) and with a longer disease duration as well as significant amelioration of the self-expertise about psoriasis in younger patients (< 50 years).ConclusionsPatients who chose to participate in an educational program show a higher gain in knowledge and self-expertise about the psoriatic disease. Educational program thus might have a positive effect on the long-term management of psoriasis. Further long-term studies are needed to provide evidence for the influence educational programs have on outcome, quality of life, and treatment adherence of psoriatic patients.Trial registrationDeutsches Register Klinischer Studien DRKS00017318 (09.10.2019), retrospectively registered.

Hypnotic Glove Anesthesia Induces Skin Temperature Changes in Adult Volunteers: A Prospective Controlled Pilot Study

This study assessed whether a focal glove hypnotic hand anesthesia induced thermal changes within the area of hypnotic protection. Skin temperature of hands, wrists, and forearms was continuously recorded bilaterally using infrared thermography in 30 volunteers. Thermal recordings were obtained prior to, after glove building, and after its withdrawal, with the contralateral upper limb serving as control side. Analgesic glove induced a statistically significant difference in temperature variation within the hand, wrist, and distal forearm on the glove side, compared with proximal forearm and control side. Hypnotic glove analgesia provides significant changes in skin temperature within protected areas. Further research is required to determine the mechanisms of these objective changes induced by hypnosis.

Safety and Efficacy of Regional Citrate Anticoagulation during Plasma Adsorption Plus Plasma Exchange Therapy for Patients with Acute-on-Chronic Liver Failure: A Pilot Study

Background: Patients with acute-on-chronic liver failure (ACLF) might be at risk for citrate accumulation during plasma adsorption plus plasma exchange (PE) therapy with regional citrate anticoagulation (RCA). Objectives: To assess the safety and efficacy of RCA during double plasma molecular adsorption system (DPMAS) plus PE therapy for patients with ACLF. Method: A prospective nonrandomized controlled pilot study was conducted at West China Hospital of Sichuan University. Patients with ACLF were enrolled to heparin anticoagulation (HA) group and RCA group. Serial blood samples were taken. Patients were followed up for 3 months. Results: Twenty-four patients with 94 sessions of HA and 28 patients with 106 sessions of RCA were enrolled. RCA method did not affect the therapeutic efficacy, the function of extracorporeal circulation, and the prognosis of these patients. The occurrences of citrate accumulation in RCA group were 0.0, 67.0, 100.0, 34.0, and 0.0% before DPMAS therapy, at the end of DPMAS therapy, immediately after PE therapy, 2 h after PE therapy, and the next morning, while that in HA group were 0.0, 0.0, 100.0, 7.4, and 0.0%, respectively. The occurrences of citrate accumulation at the end of DPMAS therapy and at 2 h after PE therapy in RCA group were much higher than that in HA group (67.0 vs. 0.0%, p = 0.000; 34.0 vs. 7.4%, p = 0.000, respectively). Although the trend of citrate accumulation in RCA group was much more obvious than that in HA group during and after DPMAS plus PE therapy (p = 0.000), the values on the next morning were similar between the 2 groups (p > 0.05). The main alteration of acid–base status was metabolic alkalosis with no difference between the 2 groups. Conclusions: RCA might be safe and effective in patients with ACLF receiving plasma adsorption plus PE therapy. RCA method might offer an alternative anticoagulation method for them.

Essentials in Minimally Invasive Gynecology Manual Skills Pilot Validation Trial

To evaluate the Essentials in Minimally Invasive Gynecology (EMIG)- Fundamentals of Laparoscopic Surgery Laparoscopic Simulation System and the EMIG Hysteroscopy Simulation System for face validity and functionality in a pilot testing environment. A prospective controlled pilot study. Three teaching institutions in the US Southwest. Twenty-seven residents and gynecologists, with 22 fitting who fit 1 of 4 categories of exposure to hysteroscopic and laparoscopic surgery and surgical simulation. Eleven were postgraduate year 1 and 5 postgraduate year 3, 1 was American Board of Obstetrics & Gynecology certified, and 5 were either fellows in-training or had completed a fellowship in minimally invasive gynecologic surgery. After completing a screening survey, each subject was exposed to a structured orientation to the 2 simulation systems and then tested with proctor supervision on the 5 laparoscopic and 2 hysteroscopic exercises. A short 5-point Likert questionnaire designed to determine face validation and question clarity was administered to each subject at sites 2 and 3. Face validity was high for each of the 7 exercises (means ranged from 4.8 to 4.9 of 5), and subjects considered instructions to be clear (means from 4.7 to 4.9). The recorded exercise times generally reduced with increasing levels of training, although the sample sizes were not designed to determine significance given the pilot design. Similarly, exercise errors were generally less frequent with increasing experience. The systems, including the devices and recording mechanisms, performed well, and proctor evaluation and training were satisfactory. The EMIG laparoscopic and hysteroscopic simulations systems were considered to have good face validity and appear to be suitable for a construct validation trial to confirm their utility in distinguishing among trainees and practitioners with a wide spectrum of endoscopic surgical experience. The recording and specimen storage mechanisms will allow for multiple proctors to rate a candidate's performance, thereby enhancing evaluation consistency and quality.

Influence of Timing on the Horizontal Stability of Connective Tissue Grafts for Buccal Soft Tissue Augmentation at Single Implants: A Prospective Controlled Pilot Study

The timing for soft tissue augmentation during implant therapy is still debated. Therefore, the present study clinically evaluated whether immediate versus delayed soft tissue augmentation procedures had an impact on the stability of peri-implant mucosal thickness (PMT). Patients requiring a single implant posterior to the canines in association with soft tissue augmentation procedures at the buccal aspect of single implants using a connective tissue graft (CTG) were enrolled. Patients were randomly allocated to 2 different timing protocols: simultaneous implant and CTG placement (test group) or implant placement and then CTG placement after 3months (control group). PMT was measured clinically at the mid-buccal aspect of the implant site by bone sounding with an endodontic K-file using customized acrylic stents. PMT measurements were recorded before and after implant placement and at 1, 2, 3, 4, 6, 9, and 12months after implant insertion. Parametric statistical tests were used to compare PMT between the test and control groups at each study period and to evaluate changes in PMT over time. The level of significance was set at a P value less than .05. Fourteen implants placed in 14 patients were available for statistical comparison. At 12months, the difference in PMT between the test and control groups was 0.12±0.51mm. This difference was not statistically significant (P=.54). A significant increase in PMT was observed from baseline to 12months after implantation in the test (P=.004) and control (P<.001) groups. The present study indicated that changes in PMT after CTG placement were not influenced by the timing of soft tissue augmentation and remained stable up to 1year after implant insertion.

Does Home-Based Progressive Resistance or High-Intensity Circuit Training Improve Strength, Function, Activity or Participation in Children With Cerebral Palsy?

ObjectiveDoes home-based progressive resistance or high-intensity circuit training improve strength, function, activity, or participation in children with cerebral palsy (CP)? DesignThis was the first study on high-intensity circuit training for children with CP. This study was conducted as a randomized prospective controlled pilot study. SettingEvaluation took place at the gait laboratory of the university hospital, training sessions were performed at home. ParticipantsChildren (N=22) with CP (average age: 12y, 10mo, 19 Gross Motor Function Classification System level I, 3 level II) were randomly assigned either to progressive resistance training (PRT) or high-intensity circuit training (HICT). InterventionsThe PRT group trained with progressive overload, while the HICT group performed as many repetitions as possible within 30-second intervals (8wk, 3 times weekly in both groups). Main Outcome MeasuresOutcome measures stretched over all domains of the International Classification of Functioning, Disability and Health and included muscle strength, muscle power sprint test (MPST), timed stairs test (TST), 6-minute walking test, Gait Profile Score (GPS), timed Up and Go test (TUGT) and participation questionnaires. ResultsOnly the HICT group was able to improve strength. Furthermore, the HICT group scored better in the MPST, while PRT participants improved in the TST and TUGT. The HICT-group was able to show improvement in the subscores of the parent-reported participation questionnaire. Other measures of mobility or participation did not change. ConclusionsBoth programs improved function specific to intervention. However, only the HICT group showed significant strength and participation improvements. Compliance was decent in both groups, but the average training unit was shorter in the HICT group. Both exercise programs showed functional benefits, but HICT might be the preferable option for strengthening in highly functional children with CP.

Randomized Controlled Pilot Study of Video Self-assessment for Resident Mastoidectomy Training.

A prospective randomized controlled pilot study was performed to determine if video self-assessment improves competency in mastoidectomy and to assess interrater agreement between expert and resident evaluations of recorded mastoidectomy. Sixteen otolaryngology residents were recorded while performing cadaveric mastoidectomy and randomized into video self-assessment and control groups. All residents performed a second recorded mastoidectomy. Performance was evaluated by blinded experts with a validated assessment scale. Video self-assessment did not lead to greater skill improvement between the first and second mastoidectomy. Interrater agreement was fair to substantial between the expert evaluators and between resident self-evaluations by recall and video review. Agreement between experts and residents was only slight to fair; residents consistently rated their performance higher than experts (P < .05). In conclusion, 1 session of video self-review did not lead to improved competence in mastoidectomy over standard practice. While experts agree on assessments, residents may overestimate their competency in performing cadaveric mastoidectomy.

The HAPI 'Hip Arthroscopy Pre-habilitation Intervention' study: does pre-habilitation affect outcomes in patients undergoing hip arthroscopy for femoro-acetabular impingement?

The purpose of this randomized prospective comparative controlled pilot study was to determine whether specific patient exercises done pre-hip arthroscopy surgery for femoro-acetabular impingement affected post-operative recovery. Between October 2013 and June 2014, 6 males and twelve females over the age of eighteen, who were listed for hip arthroscopy for femoro-acetabular impingement, were randomized into two groups. A hip-specific, 8-week home exercise programme was given to the experimental group before their surgery. The control group was given no instruction on exercise before surgery. All participants followed the same rehabilitation programme after surgery. Outcome measures were assessed at set time intervals. Hand held dynamometry was used to assess muscle strength, and the EQ-5D-5 L Score and the Non-Arthritic Hip Score were utilized. Sixteen participants completed the study (eight controls: mean age 41.75 years and eight intervention: mean age 37.5 years). A mixed ANCOVA analysis compared the treatment groups taking baseline values into account. A statistically significant difference was found between the treatment groups for knee extension strength on both operative (P = 0.05) and non-operative sides (P = 0.002), hip flexor strength operative side (P = 0.02) and for EQ-5D-5 L health (P = 0.03), in favour of the intervention group. There was no significant difference between the treatment groups for the other measures, although some tended towards significance. This small pilot study has been designed to aid the further research and the differences between the groups found in these results may inform future larger scale studies.