Minimal Clinical Difference Research Articles

Comparative effects of post isometric relaxation technique and Bowen’s therapy on pain, range of motion and function in patients with temporomandibular joint disorder

BackgroundThe most common cause of mouth and facial pain is a temporomandibular joint disorder, which affects the patient’s quality of life and interferes with their ability to perform daily tasks.ObjectiveThe purpose was to compare the effects of the Post-Isometric Relaxation Technique and Bowen’s Therapy on pain, range of motion and functional activity in patients with temporomandibular joint disorders.MethodsThis study was a randomized clinical trial. A total of 24 participants were randomly allocated into two groups using the lottery method. Baseline treatment was the same (ultrasound and tapping) in both groups. Group 1 (12 participants) was treated with a post-isometric relaxation technique, and Group 2 (12 participants) with Bowen’s therapy for two sessions per week (total duration of 4 weeks). Outcome measures were the Numeric Pain Rating Scale, Maximal mouth opening inter-incisal rural and jaw functional limitation scale-20. SPSS version 25 was used for statistical analysis.ResultsA significant improvement in pain, range of motions and functional activities in the post-isometric group showed significant results (p < 0.05) as compared to Bowen’s group (independent t-test). However, within-group comparison (paired t-test), both groups showed significant results (p < 0.05).ConclusionThis study concluded that post-isometric relaxation was more effective in terms of pain, range of motions for mouth opening, lateral deviations and functional activity of temporomandibular joint disorder patients. However, both groups showed clinical results according to minimal clinical difference values.Trial registry numberThe trial is registered under ClinicalTrials.govt with reference no. ID: NCT05392049 registered on 26/05/2022.

(126) Application of HIFEM Therapy Improves Orgasmic, Urinary and Erectile Function by Stimulation of Pelvic Floor Muscles

Abstract Introduction The weak pelvic floor in men contributes to various urological disorders. Treatment can be accomplished by strengthening the pelvic floor muscles (PFM) through pelvic floor muscle training. Nevertheless, such development of PFM is time-consuming and heavily dependent on the subject's ability to perform selective muscle contractions. An advantageous approach is the targeted stimulation of PFM which can be accomplished via electromagnetic stimulation. Particularly, the pelvic floor muscles can be non-invasively and selectively stimulated via the HIFEM field. This results in the natural development and rehabilitation of PFM, which, among other functions, plays a vital role in facilitating orgasmic, urinary and erectile function. Objective The aim of this study is to assess the safety and efficacy of the HIFEM pelvic procedure for the treatment of erectile dysfunction. Methods In this study, 28 males with a median age of 56 (30-72 years) were enrolled. The treatment was composed of ten weekly 28-minute sessions. Outcome measurements were collected via questionnaires and ultrasound imaging prior to and after the last treatment. To assess changes in erectile and sexual function, and prostate-related symptoms, the International Index of Erectile Function (IIEF) and International Prostate Symptom Score (IPSS) were used. Transverse B-Mode ultrasound video scans were recorded along the long axis of the penile shaft from the tip to the base with the penis in a flaccid state. A linear transducer was used, the depth was set at 2 cm, and the frame rate was approximately 30 frames per second. Separate video recordings of the left and right cavernosum were taken. The ultrasound scans were processed by the Morphometrix cloud-based algorithm. Adverse events were monitored during the study. Results All evaluation methods proved the efficiency of treatment on a statistically significant level. A significant improvement was detected in the majority (4 of 5) of the domains of IIEF, with the overall score improvement from a baseline value of 45.14±2.42 to 48.75±2.86 (+3.61 points). The most exceptional improvement was found in Sexual desire (+18.78%; p=1.06x10-3), Erectile dysfunction (+13.03%; p=5.7x10-4), and Orgasmic function (+10.69%; p=7.04x10-5) domains. The mean difference in the total score of the IPSS questionnaire reached -3.04 points (p=5.1x10-6), exceeding the corresponding minimal clinical difference (MIC=3 points). Overall, subjects, on average, shifted from moderately symptomatic (9.57±1.37 points) to mildly symptomatic (6.54±0.91 points). An increase in vascularity of both cavernosal was measured within 57% of patients who underwent ultrasound examination; specifically, a significant improvement was recorded in tissue segment count (TSC; +104%; p=1.17x10-4) and density (TSD; +81% p=2.20x10-3), pointing to better blood flow and delivery in examined tissues. No adverse event was observed. Conclusions The therapy administering HIFEM technology of the pelvic floor for selective PFM stimulation demonstrated significant improvement of erectile and orgasmic function and urinary symptoms. The questionnaire results corresponded with ultrasound measurements using a novel algorithm, identifying positive changes in the penile vascular system. Overall, the treatment may be considered a safe and a possible first-line solution for male patients suffering from dysfunctions linked to weakened pelvic floor muscles. Further investigation is needed. Disclosure Yes, this is sponsored by industry/sponsor: BTL. Clarification: Industry funding only - investigator initiated and executed study. Any of the authors act as a consultant, employee or shareholder of an industry for: AFFIRM Science.

Open tibial plateau fractures: Infection rate and functional outcomes

IntroductionOpen tibial plateau fractures are complex injuries that require specialized management to prevent complications. The objective of this study was to compare the infection risk and functional outcomes between open and closed tibial plateau fractures. Materials and methodsIn this multicenter cohort study the propensity score matching was used to pair participants according to age, sex, and Schatzker classification. 190 patients were followed for 1 year postoperatively. The Fracture-Related Infection (FRI) Consensus Group criteria was used to diagnose infection. Knee functionality was measured using the Oxford Knee Score scale (OKS). ResultsThe proportion of open fractures was 5.1%, and the overall incidence rate of FRI was 8% with 14% of them represented by open fractures and 4% for closed fractures (p = 0.014). Open fractures were found to be a risk factor associated with FRI, with a 5.48 times higher probability of FRI than closed fractures (odds ratio 5.41, 95% confidence interval [CI] 1.55–18.85). Among the study population, 50% had satisfactory functional outcomes of the knee (median OKS 45, IQR = 3). The median OKS was 44 (IQR = 11) in open fractures and 46 (IQR = 7) in closed ones (p = 0.03). Multivariate analysis showed that the OKS was 3 points lower for open fractures (95% CI -5.530–-0.478) than closed ones, and the score was 9.7 points lower for FRI. ConclusionOpen TPF is a risk factor that increases the probability of fracture related infections. Functional outcomes were excellent for both open and closed TPF, with a slight difference numerical that was under the minimal clinical difference (MCID). The presence of FRI significantly decreases the functional outcome.

Accuracy of Femoral Tunnel Placement between Anteromedial and Anterolateral Visualisation Portals in Anterior Cruciate Ligament Reconstruction - Outcomes of a CT based Cross-Sectional Study.

Anatomical femoral tunnel placement is critical for anterior cruciate ligament reconstruction (ACLR). Tunnel placement may vary with different surgical techniques. The aim of this study was to compare the accuracy of femoral tunnel placement between the Anteromedial (AM) and Anterolateral (AL) visualisation portals on post-operative CT scans among a cohort of ACLR patients. This cross-sectional study was conducted from January 2018 to March 2020 after obtaining ethics clearance. Patients who went for arthroscopic ACLR in our institute were divided into an AM (group 1) and an AL (group 2) based on the visualisation portal for creating the femoral tunnel and a 3D CT scan was done. The femoral tunnel position was calculated in deep to shallow and high to low direction using the Bernard Hertel grid. Femoral tunnel angle was measured in the 2D coronal image. Statistical analysis was done with the data collected. Fifty patients with an average age of 26.36 (18-55) years ±7.216 SD were enrolled in the study. In this study, the AM technique was significantly more accurate (p<0.01) than the AL technique in terms of femoral tunnel angle. Furthermore, the deep to the shallow position was significantly (p= 0.018) closer to normative values, as determined by the chi-square test. The chances of error in tunnel angle in femoral condyle are 2.6 times greater in the AL technique (minimal clinical difference). To conclude, in ACLR the anteromedial visualisation portal can facilitate accurate femoral tunnel placement compared to the anterolateral visualisation portal.

Observational study of survival outcomes of people referred for ‘fast-track’ end-of-life care funding in a district general hospital: too little too late?

BackgroundEnd-of-life care requires support for people to die where they feel safe and well-cared for. End-of-life care may require funding to support dying outside of hospital. In England, funding is...

A study on the IOS application "uHear" as a screening tool for hearing loss in Bangkok.

This study was designed to compare the results of hearing tests performed using the uHear application with those of standard audiometry in Thai people in Bangkok. From December 2018 to November 2019, a prospective observational study was conducted involving Thai participants aged between 18 and 80 years. All participants were tested using standard audiometry and the uHear application in a soundproof booth and in a typical hearing environment. This study included 52 participants (12 males and 40 females). The Bland-Altman plot with the Minimal Clinical Meaningful Difference of 10dB between standard audiometry and the uHear in a soundproof booth found agreement at 2000 Hz. The uHear in a soundproof booth showed high sensitivity at all frequencies (82.5%-98.9%) and high specificity at 500 and 1000 Hz (85.7%-100%). uHear in a typical hearing environment showed high sensitivity at 4000 and 6000 Hz (97.6%) and high specificity at 500 and 1000 Hz (100%). When considering the pure-tone average, uHear in a soundproof booth showed high sensitivity (94.7%) and specificity (90.7%), whereas, in a typical hearing environment, uHear showed poor sensitivity (34%) and high specificity (100%). uHear was accurate for hearing loss screening at 2000 Hz in a soundproof booth. However, uHear in a typical hearing environment lacked accuracy. The uHear application in a soundproof booth can be used to screen hearing loss in some situations where standard audiometry is impossible. II.

A novel GnRH antagonist protocol based on LH levels versus traditional flexible GnRH antagonist protocol in PCOS patients undergoing in vitro fertilization: study protocol for a randomized controlled, non-inferiority trial

BackgroundThe gonadotropin-releasing hormone (GnRH) antagonist protocol is advantageous given that it can avoid severe ovarian hyperstimulation syndrome (OHSS), especially for patients with polycystic ovary syndrome (PCOS). Basic and clinical evidence has shown that a threshold of luteinizing hormone (LH) stimulation is required for adequate follicular development and oocyte maturation. Ultra-low or high levels of LH are detrimental to pregnancy outcomes. We previously demonstrated that LH could be an indicator for the timing and dosage of antagonist administration in a retrospective study.Methods/designIn this randomized, single-center, non-inferiority trial, we aim to test the hypothesis that there is no significant difference in cumulative ongoing pregnancy rates between PCOS patients stimulated with LH-based flexible protocol versus traditional flexible GnRH antagonist protocol. The primary efficacy endpoint will be the cumulative ongoing pregnancy rate per cycle. The secondary outcomes will be clinical pregnancy rate, cancelation rate, serious OHSS rate, and cost-efficiency. The cumulative ongoing pregnancy rate per cycle in PCOS women was 80%. Considering that a non-inferiority threshold should retain 80% of the clinical effect of a control treatment, a minimal clinical difference of 16% (two-sided: α, 2.5%; β, 20%) and a total of 196 patients were needed. Anticipating a 10% dropout rate, the total number of patients required was 216.DiscussionThe results of this study will provide evidence for the efficacy and safety of the LH-based flexible GnRH antagonist protocol in PCOS patients. Moreover, it evaluates the cost-efficiency of both protocols.Trial registrationChinese Clinical Trial Registry ChiCTR1800018129. Date assigned: 31 August 2018. Protocol version: 1.0 (18 July 2017)

Minimum 2-Year Radiographic and Clinical Outcomes of Unrestricted Kinematic Alignment Total Knee Arthroplasty in Patients with Excessive Varus of the Tibia Component.

Kinematic alignment (KA) total knee arthroplasty (TKA) has gained much attention in recent years. However, debate remains on whether restrictions should be made on the tibia cut. The purpose of this study was to assess the safety and functional outcomes of excessive varus cuts. A single-center, retrospective analysis of consecutive patients undergoing TKA between 2018 and 2020 who had a minimum 2-year follow-up was conducted. EOS™ imaging conducted before and after surgery was analyzed for overall alignment, as well as for tibia and femur component positioning on the coronal planes. Patients were interviewed and asked to fill several questionnaires, including the visual analog score, Oxford knee score, and knee injury and osteoarthritis outcome score. Overall, 243 patients (71.9%) had a coronal tibial plate angle under 5° (moderate) and 95 patients (28.1%) had an angle above 5° (excessive). There were no significant differences between the moderate and excessive groups in patient-reported outcomes, nor were there differences in the number of patients achieving the minimal clinical difference. There were no cases of catastrophic failure or loosening. Unrestricted KA and excessive varus of the tibial component appears to be safe and efficient in relieving pain and restoring function for a minimum of 2 years following surgery.

Combined Artificial Intelligence Approaches Analyzing 1000 Conservative Patients with Back Pain-A Methodological Pathway to Predicting Treatment Efficacy and Diagnostic Groups.

Patients with back pain are common and present a challenge in everyday medical practice due to the multitude of possible causes and the individual effects of treatments. Predicting causes and therapy efficien cy with the help of artificial intelligence could improve and simplify the treatment. In an exemplary collective of 1000 conservatively treated back pain patients, it was investigated whether the prediction of therapy efficiency and the underlying diagnosis is possible by combining different artificial intelligence approaches. For this purpose, supervised and unsupervised artificial intelligence methods were analyzed and a methodology for combining the predictions was developed. Supervised AI is suitable for predicting therapy efficiency at the borderline of minimal clinical difference. Non-supervised AI can show patterns in the dataset. We can show that the identification of the underlying diagnostic groups only becomes possible through a combination of different AI approaches and the baseline data. The presented methodology for the combined application of artificial intelligence algorithms shows a transferable path to establish correlations in heterogeneous data sets when individual AI approaches only provide weak results.

250. The association between patient activation and patient reported outcomes (PROs) for patients undergoing elective spine surgery

<h3>BACKGROUND CONTEXT</h3> Patient activation refers to the extent with which patients play an active, engaged role in their own health care. An increasing number of studies in spine and broader orthopedic literature have found patient activation to be both modifiable and an independent predictor of clinical outcomes, including satisfaction. No prior studies, however, have explored the impact of patient activation on whether patients achieve minimal clinical improvement difference (MCID) for PROMIS pain and physical function at 1-year follow-up. <h3>PURPOSE</h3> To determine whether patient activation, a modifiable risk factor, predicts MCID for PROMIS pain and physical function for patients undergoing elective cervical or thoracolumbar spine surgery. <h3>STUDY DESIGN/SETTING</h3> Retrospective review of single, academic institution database. <h3>PATIENT SAMPLE</h3> A total of 430 patients were identified who had undergone elective spine surgery and had minimum 1-year follow-up. <h3>OUTCOME MEASURES</h3> The primary outcome measure was whether patients achieved MCID for PROMIS pain and physical function at 1-year follow-up. <h3>METHODS</h3> We retrospectively reviewed a single-institution, academic database of patients undergoing elective cervical or thoracolumbar spine surgery. Inclusion criteria was (1) age 18 or older, and (2) minimum 1-year follow-up. We assessed patient activation using the validated Patient Activation Measures-13 (PAM-13) survey. Using the PAM-13 survey, we can numerically quantify patient activation and stratify patients into one of four stages of activation (I, II, III, IV), with a higher stage indicating greater activation. Primary outcome variable was achieving MCID at 1-year follow-up for PROMIS pain and physical function. Multivariable logistic regression analysis was used to determine impact of patient activation on MCID for PROMIS pain and physical function while controlling for demographics (age, sex), income and education. <h3>RESULTS</h3> Of the 430 patients meeting inclusion criteria, 210 (49%) were female with a mean age of 58.2 ± 16.8. Preoperatively, 34 (8%) were in activation stage 1, 45 (10%) in stage 2, 98 (23%) in stage 3, and 253 (59%) in stage 4. At 1-year postoperative follow up, 248 (58%) achieved MCID for PROMIS function and 256 (60%) achieved MCID for PROMIS pain. Using multivariable logistic regression, patients at higher stages of activation were more likely to achieve MCID for both PROMIS pain and physical function, compared to patients at stage 1 activation. With regards to PROMIS physical function, when compared to patients at stage 1 activation, patients at stage 2 (aOR:3.40, 95% CI: 1.25, 9.30), stage 3 (aOR:3.39, 95% CI: 1.34, 8.56) and stage 4 (aOR:7.63, 95% CI: 3.19, 18.3) were far more likely to achieve MCID. With regards to PROMIS pain, when compared against patients at stage 1, patients at stage 3 (aOR:2.78, 95% CI: 1.17, 6.63) and stage 4 (aOR:5.49, 95% CI: 2.43, 12.4) were far more likely to achieve MCID. Of note, for PROMIS pain, no difference in achieving MCID were observed between patients at stage 1 and 2. <h3>CONCLUSIONS</h3> We found patient activation to be an independent predictor of MCID for both PROMIS pain and physical function for patients undergoing elective spine surgery. Given our findings, we recommend routine assessment of patient activation. And, for patients found to be at the lowest stage of activation, they should be counseled regarding the increased risk of poor outcomes, and interventions to increase activation should be considered. <h3>FDA DEVICE/DRUG STATUS</h3> This abstract does not discuss or include any applicable devices or drugs.

Direct to Thrombectomy.

Direct to Thrombectomy.

Multicenter Outcomes After Primary Hip Arthroscopy: A Comparative Analysis of Two-Year Outcomes After Labral Repair, Segmental Labral Reconstruction, or Circumferential Labral Reconstruction

(1) To report minimum 2-year follow-up patient-reported outcome measures in patients undergoing labral repair (LR), segmental labral reconstruction (SLR), or circumferential labral reconstruction (CLR) in the primary setting; and (2) to compare minimum 2-year follow-up patient-reported outcome measures among these groups. A retrospective review of a prospectively maintained multicenter database of patients undergoing hip arthroscopy was performed. Inclusion criteria were patients undergoing hip arthroscopy for treatment of labral tear and femoroacetabular impingement syndrome between January 2014 and October 2017, and completion of minimum 2-year postoperative outcome scores. Exclusion criteria were patients undergoing revision hip surgery, labral treatment limited to debridement, lateral center-edge angle <20°, osteoarthritis (Tönnis grade > 1), slipped capital femoral epiphysis, workers compensation status, and patients undergoing concomitant gluteus medius and/or minimus repair. Labral reconstruction patients were matched (1:3) with labral repair patients on age, sex, and body mass index. The labral reconstruction group was further stratified into SLR, and CLR groups. Patient demographic characteristics and clinical outcomes including Hip Outcome Score - Activities of Daily Living, Hip Outcome Score - Sport Subscale, modified Harris Hip Score, international Hip Outcome Tool, and visual analog scale for pain were analyzed, as well as achievement of the minimal clinical improvement difference (MCID). A P-value less than .05 indicated statistical significance. A total of 416 patients were included (LR, n= 312; SLR, n= 53; CLR, n= 51). The age, body mass index, and sex of the matched cohort were 42.3 ± 11.2 years, 24.7 ± 3.7, and 55.0% female. At a minimum of 2-year after hip arthroscopic surgery, no differences were found in preoperative, postoperative, or the delta visual analog scale for pain, modified Harris Hip Score, Hip Outcome Score - Activities of Daily Living, Hip Outcome Score - Sport Subscale, or international Hip Outcome Tool. Subsequently, the proportion of patients achieving the MCID and the PASS at latest follow-up were analyzed. This analysis revealed that no significant differences in the rate of MCID or PASS achievement for any outcome measure existed based on labral treatment. In this multicenter study on labral treatment in the primary setting, patients undergoing LR, SLR, and CLR demonstrated no difference in preoperative or postoperative scores, nor the proportion of patients achieving clinically significant outcome improvement. III; therapeutic outcome study with controls.

Rice flour fermented with Lactobacillus paracasei CBA L74 in the treatment of atopic dermatitis in infants: A randomized, double- blind, placebo- controlled trial

To assess the effect of a fermented rice-flour obtained from Lactobacillus paracasei CBA L74 in managing infants with moderate to severe atopic dermatitis. Infants with moderate to severe atopic dermatitis, aged 6–36 months, were randomly assigned to receive once-daily consumption of rice flour containing heat-killed probiotic Lactobacillus paracasei CBA L74 or placebo for 12 weeks as supplementary approach to topical treatment. Primary outcome was SCORAD index change from baseline to 12 weeks; secondary outcomes were gut microbiota composition, as evaluated by the analysis of fecal samples, and serum cytokines at baseline and at the end of the intervention period in both groups, and steroid usage over the treatment period and one month after stopping it. V3–V4 region of the 16S ribosomal RNA gene was sequenced to evaluate changes in the gut microbiota. SCORAD index decreased over the treatment period in both groups. The difference in the SCORAD change was -2.1 (-5.5 to 1.3; p = 0.223) for the experimental vs. the placebo group, not reaching the minimal clinical difference of 8.7 units. The use of topical steroids, measured as finger tips units, decreased from 4 to 16 weeks, in both groups; the reduction was significantly higher in experimental than in placebo group (p value from Wilcoxon rank sum test = 0.031). No significant differences were observed for cytokines levels between groups. The composition of gut microbiota at the phylum and class taxonomic levels resulted very similar, at baseline and after intervention, in both groups. Similarly, no significant differences were observed in the relative abundance of bacterial genera between groups. In conclusion, though the heat-killed Lactobacillus paracaseiwas not proved to be effective in reducing the severity of atopic dermatitis, it showed a steroid sparing effect the value of which needs to be further investigated.

Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events and Quality-of-Life Linear Analogue Self-Assessment in Breast Cancer Patients Receiving Radiation Therapy: Single-Institution Prospective Registry

We sought to investigate the impact of Patient Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) on overall quality-of-life (QOL) employing Linear Analogue Self-Assessment (LASA) in breast cancer (BC) patients undergoing radiation therapy (RT) in a single-institution prospective registry. All patients treated with RT for BC with curative intent from 2015 to 2019 at our institution were eligible for this analysis. Breast specific PRO-CTCAE and overall LASA QOL questionnaires were administered at baseline, end-of-treatment, 3, 6, 12 months, and then annually. A patient was considered to have patient-reported treatment-related symptomatic AEs (PAE) at each time-point, if she had a score of 3 or higher (“severe” or worse) for any breast specific PRO-CTCAE item that was higher than baseline. Minimal clinical difference in overall QOL was considered to be a 10-point change in LASA score. Hypofractionation was defined as any treatment >2 Gy per fraction. Repeated measures mixed models were used to determine the effect PRO-CTCAE had on overall QOL based on LASA. Three-hundred and two (392) patients with a median follow-up of 2.3 years (range, 0.4–3.9) were included for analysis. Patient and treatment characteristics included: 8% pT0, 15% pTis, 50% pT1, 21% pT2, 6% pT3, 63% pN0, 17% pN1, 6% pN2, 3% pN3, 11% pN not reported, 81% ER+, 77% PR+, 11% HER2+, 65% ECOG 0, and median body mass index (BMI) 27.3 (range, 16.4 – 53.8). Treatment characteristics included: median dose 40.05 Gy (range, 40–50.4 Gy), 74% treated with hypofractionation, 42% received a boost (median 10 Gy, range 5.4–12 Gy), 86% treated with photons, 14% treated with proton beam therapy, 76% underwent lumpectomy, and 41% received chemotherapy. Average overall QOL LASA scores for all patients were 78.5 at baseline, 79.8 at end of treatment, 79.8 at 3 months, 77.1 at 6 months, 79.4 at 12 months, and 79.7 at 24 months. On univariate analysis, patients who reported a PAE had, on average, a 9.8-point reduction in overall LASA QOL (p<.0001). On multivariate analysis, not being treated with hypofractionation and higher BMI were predictive for worse overall LASA QOL with a 9.5-point reduction in LASA for patients who reported a PAE (p<.0001). While average overall QOL according to LASA did not change during follow-up for all patients treated with curative intend RT for BC, patients who reported a worsening breast-specific PRO-CTCAE item to “severe” or worse experienced statistically significant and clinically meaningful deterioration in overall QOL based on LASA scale. The use of hypofractionation significantly improved overall QOL while higher BMI predicted for worse QOL. These results contribute to the understanding of PRO-CTCAE for breast cancer patients and promote the value of integration of PRO-CTCAE items into future clinical trials.

Intraoperative aberrometry vs modern preoperative formulas in predicting intraocular lens power.

To compare the outcomes of an intraoperative aberrometer (ORA) to the Barrett Universal II (Barrett II) and Hill-RBF 2.0 (Hill-RBF) intraocular lens (IOL) power calculation formulas. Duke University Eye Center, Durham, North Carolina, USA. Retrospective study. Patients without history of refractive corneal surgery who had an uneventful cataract surgery from April 2016 to June 2018 were enrolled. Refractive prediction error was calculated with the Barrett II formula, the Hill-RBF formula, and the ORA intraoperative aberrometer (OIA) and was stratified by axial length, IOL type, and the percentage of eyes within a diopteric range of target refraction. Nine-hundred forty-nine eyes were included. The mean and median absolute predictive errors were 0.29 diopters (D) and 0.23 D (Barrett II), 0.31 D and 0.24 D (Hill-RBF), and 0.31 D and 0.25 D (intraoperative aberrometry), respectively (P > .05). Axial length stratification did not influence statistical difference in the IOL prediction methods. Barrett II outperformed the OIA toric multifocal (P = .011) group. Postoperative refraction was within 0.50 D of target in 84% (Barrett II), 83% (Hill-RBF), and 82% (OIA) of eyes (P > .05). Comparing the OIA to the Barrett II and Hill-RBF calculators, there was minimal clinical difference in the toric multifocal group. Regarding postoperative predicted spherical equivalent, for patients without a history of refractive surgery and good potential visual acuity, refractive outcome was not improved by utilizing the OIA.

Psychological therapies for people with borderline personality disorder.

Psychological therapies for people with borderline personality disorder.

Cross-cultural adaptation and validation of the RhinAsthma Patient Perspective (RAPP) in Spanish

Objectivethe RhinAsthma Patient Perspective (RAPP) is the only available tool to assess HRQoL in daily practice. The aim of this study is to cross-culturally validate the RAPP in Spanish. MethodsThe RAPP was translated into Spanish. Adult patients receiving usual care for asthma and allergic rhinitis (AR) were recruited consecutively and assessed twice with a four-week interval between visits to test the psychometric properties of the questionnaire. Results149 patients (62.8% female) with a mean age of 37.7 years completed the study. Exploratory and confirmatory factor analysis confirmed the uni-dimensional structure of the questionnaire. Internal consistency (0.73 at visit 1; 0.87 at visit 2), convergent and discriminant validity (p<.05 at both visits) were satisfactory. Reliability was confirmed by an ICC of 0.69 and a CCC of 0.74. Responsiveness was supported by a significant association with VAS (r=0.28, p<0.003) and ACT (r=−0.35, p<0.01). The minimal clinical difference (MID) value in the analyzed population was 2. ConclusionsThe Spanish version of RAPP was demonstrated to have satisfactory psychometric properties and is a valid, reliable and responsive tool for the assessment of asthma and AR HRQoL in clinical practice.

Social skills training for attention deficit hyperactivity disorder (ADHD) in children aged 5 to 18 years.

Attention deficit hyperactivity disorder (ADHD) in children is associated with hyperactivity and impulsivity, attention problems, and difficulties with social interactions. Pharmacological treatment may alleviate the symptoms of ADHD but this rarely solves difficulties with social interactions. Children with ADHD may benefit from interventions designed to improve their social skills. We examined the benefits and harms of social skills training on social skills, emotional competencies, general behaviour, ADHD symptoms, performance in school of children with ADHD, and adverse events. To assess the beneficial and harmful effects of social skills training in children and adolescents with ADHD. In July 2018, we searched CENTRAL, MEDLINE, Embase, PsycINFO, 4 other databases and two trials registers.We also searched online conference abstracts, and contacted experts in the field for information about unpublished or ongoing randomised clinical trials. We did not limit our searches by language, year of publication, or type or status of publication, and we sought translation of the relevant sections of non-English language articles. Randomised clinical trials investigating social skills training versus either no intervention or waiting-list control, with or without pharmacological treatment of both comparison groups of children and adolescents with ADHD. We conducted the review in accordance with the Cochrane Handbook for Systematic Reviews of Intervention. We performed the analyses using Review Manager 5 software and Trial Sequential Analysis. We assessed bias according to domains for systematic errors. We assessed the certainty of the evidence with the GRADE approach. We included 25 randomised clinical trials described in 45 reports. The trials included a total of 2690 participants aged between five and 17 years. In 17 trials, participants were also diagnosed with various comorbidities.The social skills interventions were described as: 1) social skills training, 2) cognitive behavioural therapy, 3) multimodal behavioural/psychosocial therapy, 4) child life and attention skills treatment, 5) life skills training, 6) the "challenging horizon programme", 7) verbal self-instruction, 8) meta-cognitive training, 9) behavioural therapy, 10) behavioural and social skills treatment, and 11) psychosocial treatment. The control interventions were no intervention or waiting list.The duration of the interventions ranged from five weeks to two years. We considered the content of the social skills interventionsto be comparable and based on a cognitive-behavioural model.Most of the trials compared child social skills training or parent training combined with medication versus medication alone. Some of the experimental interventions also included teacher consultations.More than half of the trials were at high risk of bias for generation of the allocation sequence and allocation concealment. No trial reported on blinding of participants and personnel. Most of the trials did not report on differences between groups in medication for comorbid disorders. We used all eligible trials in the meta-analyses, but downgraded the certainty of the evidence to low or very low.We found no clinically relevant treatment effect of social skills interventions on the primary outcome measures: teacher-rated social skills at end of treatment (standardised mean difference (SMD) 0.11, 95% confidence interval (CI) 0.00 to 0.22; 11 trials, 1271 participants; I2 = 0%; P = 0.05); teacher-rated emotional competencies at end of treatment (SMD -0.02, 95% CI -0.72 to 0.68; two trials, 129 participants; I2 = 74%; P = 0.96); or on teacher-rated general behaviour (SMD -0.06 (negative value better), 95% CI -0.19 to 0.06; eight trials, 1002 participants; I2 = 0%; P = 0.33). The effect on the primary outcome, teacher-rated social skills at end of treatment, corresponds to a MD of 1.22 points on the social skills rating system (SSRS) scale (95% CI 0.09 to 2.36). The minimal clinical relevant difference (10%) on the SSRS is 10.0 points (range 0 to 102 points on SSRS).We found evidence in favour of social skills training on teacher-rated core ADHD symptoms at end of treatment for all eligible trials (SMD -0.26, 95% CI -0.47 to -0.05; 14 trials, 1379 participants; I2= 69%; P = 0.02), but the finding is questionable due to lack of support from sensitivity analyses, high risk of bias, lack of clinical significance, high heterogeneity, and low certainty.The studies did not report any serious or non-serious adverse events. The review suggests that there is little evidence to support or refute social skills training for children and adolescents with ADHD. We may need more trials that are at low risk of bias and a sufficient number of participants to determine the efficacy of social skills training versus no training for ADHD. The evidence base regarding adolescents is especially weak.

The quality of life in neoadjuvant versus adjuvant therapy of esophageal cancer treatment trial (QUINTETT).

4052 Background: We compared the health-related quality-of-life (HRQOL) of standard neoadjuvant cisplatin and 5-FU chemotherapy plus radiotherapy (N) followed by surgical resection to adjuvant cisplatin, 5-FU, and epirubicin chemotherapy with concurrent extended volume radiotherapy (A) following surgical resection for resectable esophageal carcinoma. Methods: 96 patients with stage I to III resectable cancer of the esophagus were enrolled into a prospective randomized trial (NCT00907543) from April 2009 to November 2016. Patients were randomized into 2 groups: N (47 cases) and A (49 cases). The primary end point was HRQOL using the FACT-E at one year. The secondary endpoints included other HRQOL measures, overall survival (OS), disease-free survival (DFS), and adverse events. Results: The median follow-up was 5.0 years [95% CI :4.6 to 5.5]. The majority of patients had adenocarcinomas of the distal esophagus/gastroesophageal junction (80.9% vs 87.8%). The stage distribution was: I 9%; II 22%; III 58%; TxN0-1 10%. Using an intention-to-treat analysis there was no significant difference in the FACT-E total scores between arms at one year (p = 0.759), with 35.5% vs. 41.2% respectively showing an increase of ≥ 15 points ( a priori minimal clinical difference) compared to pre-treatment (p = 0.638). The HRQOL was temporarily significantly inferior at 2 months in the N arm for FACT-E, EORTC OG25, and EQ-5D-3L in the dysphagia, reflux, pain, taste, and coughing domains (p &lt; 0.05). There were no 30-day mortalities but 2.1% vs. 10.2% 90-day mortalities (p = 0.204). There were no significant differences in either 5-year OS (37.9% vs 28.9%, p = 0.321) or DFS (34.0% vs 25.5%, p = 0.551. 48.9% of patients required chemotherapy to be modified or stopped in the N arm compared to 57.1% in the A arm (p = 0.421). 51.1% of patients were able to complete the prescribed N arm chemotherapy without modification compared to only 14.3% in the A arm (p &lt; 0.001). Chemotherapy related adverse events significantly more frequent in the neoadjuvant arm (p &lt; 0.05). Surgery related adverse events were significantly more frequent in the neoadjuvant arm (p &lt; 0.05). Conclusions: Trimodality therapy is challenging for patients with resectable esophageal cancer regardless if it is given before or after surgery. Less toxic protocols are needed. Clinical trial information: 00907543.

Manual therapy for chronic migraine: a pragmatic randomised controlled trial study protocol

IntroductionChronic migraine is a largely refractory condition affecting between 1 and 2.2% of the overall population worldwide, with females more affected than males. There are also high health and socioeconomic costs associated both for the individual and society. The mainstay of chronic migraine management is pharmacological, but the options available have limited efficacy and there are often unwanted side effects. There is some evidence for manual therapy as a treatment option for migraine, but its effectiveness for chronic migraine is unknown. Therefore, we have designed a pragmatic randomised control trial to investigate whether adding manual therapy to the tertiary specialist treatment of chronic migraine improves patient-reported outcomes.MethodsA pragmatic, randomised controlled trial in a hospital tertiary headache clinic. Participants will be randomised into one of two groups: treatment as usual or treatment as usual plus manual therapy. The primary outcome measure will be a change in the Headache Impact Test score. Secondary outcomes will also be measured over the 12-week study period including changes in headache frequency, migraine specific quality of life and reductions in relevant medicine consumption. The manual therapy group will have five treatment sessions each lasting 30 min. The recruitment target of 64 participants will allow power at 80% with p = 0.05 using minimal clinical difference for Headache Impact Test of 3.7 and includes provision for a 10% dropout rate. Recruitment will take place between August 2018 and February 2019. The results will form part of a doctoral study and be published in peer-reviewed journals and presented at national/international conferences.DiscussionCurrent pharmacological approaches have limited effects in the management of chronic migraine and there is a requirement to improve treatment options and reduce the health and economic burden of the condition. Manual therapy has been shown to be effective in other chronic pain conditions as well as other primary headaches. This study will explore the effectiveness of manual therapy as an adjunctive approach to the management of chronic migraine.Trial registrationThe trial has received a favourable opinion from the UK Health Research Authority (IRAS 228901) and is registered at ClinicalTrials.gov.number NCT03395457. Registered 1st March 2018.