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INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic has accelerated the move towards home spirometry monitoring, including in children. The aim of this study is to determine whether the remote supervision of spirometry by a physiologist improves the technical quality and failure rate of the maneuvers. METHOD: Children with cystic fibrosis who had been provided with NuvoAir home spirometers were randomly allocated to either supervised or unsupervised home spirometry following a detailed training session. Home spirometry was performed every 2 weeks for 12 weeks. Tests were assigned a quality factor (QF) using our laboratory grading system as per American Thoracic Society/European Respiratory Society standards, with tests marked from A to D, or Fail. In our laboratory, we aim for QF A in all spirometry tests, but report results of QF B or C with a cautionary note. QF A was, therefore, the primary outcome, and QF A-C, the secondary outcome. RESULTS: Sixty-one patients were enrolled; 166 measurements were obtained in the supervised group, and 153 in the unsupervised group. Significantly more measurements achieved QF A in the supervised compared to unsupervised group (89% vs. 74%; p =

Purpose To systematically review past studies to determine the effect of various solutions on the color of denture teeth, thus answering the question in regards to which type of denture teeth has the best optical properties after exposure to various solutions. The method of measuring the color of artificial teeth was also evaluated as a secondary outcome. Materials and methods A search of studies that quantitatively investigated the influence of immersion solutions on the color change of denture teeth was conducted. Ovid MEDLINE, PubMed and Scopus databases were searched from 1997 to April 2021. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used during article selection. Data regarding the effect of immersion solutions, accelerated aging and surface treatments on color change were gathered. Methodologies used to assess optical properties were also summarised and compared. The modified CONSORT checklist was used to determine the risk of bias of past studied included in this review. Results 133 studies were identified after removing duplicates. Forty-one studies were selected for full-text analysis, and 35 remaining papers met the inclusion criteria and were therefore included in this systematic review. Thirty-two in vitro studies and 3 in vivo studies were included in the review. All studies reported that immersion in various solutions has a significant influence on the change in color and optical properties of denture teeth. However, the discolouration of denture teeth is still clinically acceptable in most studies. Exposure to various solution also affected the translucency parameter of denture teeth. Most studies also investigated the surface roughness and hardness along with the optical properties, and reported that immersion cycles did not cause changes in surface roughness of denture teeth, while hardness was affected. The optical properties of PMMA denture teeth have been studied extensively, whereas that of CAD/CAM and 3D printed denture teeth is limited. Conclusions Color stability of CAD/CAM milled denture teeth is comparable to conventional PMMA denture teeth. There are contradictory findings in terms of color stability of 3D printed denture teeth as compared to conventional PMMA denture teeth. Staining by coffee is worst among the common beverages and solutions investigated. Denture teeth can show color changes after immersion in staining beverages as early as one week. The degree of discoloration of denture teeth after immersion is time dependent, with the larger extent in the initial phase. This article is protected by copyright. All rights reserved.

OBJECTIVE Previous research indicated that the International Committee of Medical Journal Editors guidelines of prospective trial registration with clearly identified primary and secondary outcome measures are only adhered to in 14.4% of studies published in the top five psychiatry journals between 1 January 2009 and 31 July 2013. This study examined if adherence has improved. METHODS The registration information, article information, primary outcome measures (POMs), participant numbers and funding source were extracted from studies published in the same five psychiatry journals between 1 January 2015 and 31 December 2019. Discrepancies between POMs in the articles and registry were tracked. RESULTS Of the 7268 publications, 268 studies required registration. Three (1.1%) were unregistered, 107 (39.9%) were retrospectively registered, and 158 (58.9%) were prospectively registered. Of the 158 prospectively registered studies, 16 (10.1%) had unclear POMs in the article or registration, 22 (13.9%) had discrepancies between registered and published POMs, and 33 (20.9%) had no POM discrepancies but had retrospectively updated POMs in the registry. Of the 22 studies with discrepancies, nine (40.9%) were determined to favour statistically significant results. Overall, 87 (32.5%) of the 268 studies were prospectively registered with no discrepancies between registered and published POMs and no changes to registered POMs or timeframes. CONCLUSION Although this rate of one third of published articles fully adhering to the guidelines is an improvement compared to previous research, further efforts still need to be made by both authors and journals to ensure full transparency in the reporting of studies in psychiatry.

Aims Intense health‐care service use and high mortality are common in heart failure (HF) patients. This secondary analysis of the MOTIVATE‐HF trial investigates the effectiveness of motivational interviewing (MI) in reducing health‐care service use (e.g. emergency service use and hospitalizations) and all‐cause mortality. Methods and results This study used a randomized controlled trial. Patients and caregivers were randomized to Arm 1 (MI for patients), Arm 2 (MI for patients and caregivers), or Arm 3 (control group). Data were collected at baseline and at 3, 6, 9, and 12 months. Face‐to‐face MI plus three telephone calls were performed in Arms 1 and 2. The sample consisted of 510 patient (median age 74 years, 58% male patients) and caregiver dyads (median age 55 years, 75% female patients). At 12 months, 16.1%, 17%, and 11.2% of patients used health‐care services at least once in Arms 1, 2, and 3, respectively, without significant difference. At 3 months, 1.9%, 0.6%, and 5.1% of patients died in Arms 1, 2, and 3, respectively. Mortality was lower in Arm 2 vs. Arm 3 at 3 months [hazard ratio (HR) = 0.112, 95% CI: 0.014–0.882, P = 0.04]; no difference was found at subsequent follow‐ups. Mortality was lower in Arm 1 vs. Arm 3 at 3 months but did not reach statistical significance (HR = 0.38, 95% CI: 0.104–1.414, P = 0.15). Conclusion This study suggests that MI reduces mortality in patients with HF if caregivers are included in the intervention. Further studies with a stronger intervention and longer follow‐up are needed to clarify the benefits of MI on health‐care service use and mortality.

OBJECTIVES/HYPOTHESIS: Vocal fold movement impairment (VFMI) in infants and children is most commonly evaluated by flexible nasolaryngoscopy (FNL). FNL in this population can be challenging due to movement, floppy supraglottic structures, or secretions. Laryngeal ultrasound (LUS) may be an alternative, less invasive means of evaluating VFMI that also decreases aerosolization during the COVID-19 pandemic. The primary objective was to examine LUS interpretation proficiency for VFMI via an educational module. A secondary outcome was to determine whether quantitative measurements increase interpretation accuracy. STUDY DESIGN: Prospective cohort trial. METHODS: Medical students, residents, fellows, faculty, and staff were recruited to complete the module, composed of a 13-minute teaching video followed by 20 cases. Participants determined both qualitatively (subjective assessment) and then quantitatively (through protractor measurements of the vocal fold to arytenoid angle) whether there was normal versus impaired vocal fold mobility. RESULTS: Thirty participants completed the LUS training module, and about one-third were otolaryngology residents. On average, each participant correctly identified 18 cases. The mean rank percent correct for quantitative measurements was significantly higher than that of qualitative interpretations (P < .0001). Measurements significantly caused participants to change their answer correctly compared to incorrectly (P < .0001). As the module progressed, there was no significant trend of more correct interpretations (P = .30). The sensitivity was higher for quantitative interpretations (89.0% vs. 87.3%) but specificity remained unchanged (92.6%). CONCLUSION: Quantitative measurements may increase LUS interpretation accuracy. There was not a specific number of cases interpreted to achieve learning proficiency. LUS is an easily learned method to evaluate for VFMI across all training levels. LEVEL OF EVIDENCE: 3 (local cohort study nonrandomized) Laryngoscope, 2021.

Aims Female sex and heart failure (HF) are considered poor prognostic factors for surgery. We aimed to investigate the association between sex and surgical outcomes in patients with ischaemic HF undergoing surgical ventricular reconstruction and coronary artery bypass grafting. Methods and results From July 2001 to June 2017, 648 patients [111 women (17%) and 537 men (83%)] were referred to our centre. Follow‐up continued through June 2018. All patients underwent surgical ventricular reconstruction; coronary artery bypass grafting was performed in 582 patients (90%). Primary outcome was defined as all‐cause mortality. Secondary outcome included all‐cause mortality or all‐cause hospitalization. Women were older (70 vs. 65 years, P

To investigate differences in heart rate variability (HRV) during oral glucose tolerance tests (OGTTs) in response to the rate of change in glucose and to different glycaemic ranges in individuals with type 1 diabetes. This was a single‐centre, prospective, secondary outcome analysis in 17 individuals with type 1 diabetes (glycated haemoglobin 53 ± 6.3 mmol/L), who underwent two OGTTs (after 12 and 36 hours of fasting) investigating differences in HRV in response to rapid glucose increases/decreases and different glycaemic ranges during OGTT. Based on the rate of change in glucose level, the variables heart rate (P 50 ms difference (P

Rapid maxillary expansion (RME) is performed on transversely deficient maxilla. As all orthodontic treatments, retention is important in maintaining therapeutic outcomes. Fixed /removable retainers are used post-RME causing hygiene and compliance problems. Given photobiomodulation's positive effects on the quantity and quality of bone regeneration, its effect on post-RME relapse was studied. Thirty Sprague Dawley rats were randomly divided into group R, non-irradiated RME-treated (n = 12), group P, irradiated RME-treated (n = 12) and group C, non-RME non-irradiated (n = 6). A 1.5 mm metal ring inserted between maxillary incisors at days 0 and 15 was expanded until 1.5 mm space was obtained at day 30. In group P, Ga-Al-As diode laser (810 nm, 100 mW, 4J/cm2 , 30 secs) was applied on days 0, 2, 4, 6, 8, 10, 12 and 14 as predictor variable. The relapse was measured as the space lost between incisors for 30 days after appliance removal (primary outcome variable) and compared with t-test. In week 2, space loss in group P was significantly lower (P < 0.05) than all other groups. The relapse during weeks 2 and 3 was significantly lower in group P than group R. However, no significant difference in relapse amount was found between groups during first and fourth week. There was a significant difference (P < 0.05) between groups in relapse rates (secondary outcome variable) but not in total relapse after 4 weeks. Photobiomodulation proved beneficial in resisting relapse in our study, and it is suggested to be continued until the end of expansion.

This review aims to synthesize the evaluation evidence for parent‐engagement programs that focus on reducing juvenile truancy as the primary outcome. Delinquent behavior will be assessed as a secondary outcome when included. This objective is guided by the following research questions: (1) what is the effectiveness of parent‐engagement programs for children in preschool (ages 4–5) through secondary education (ages 13–19) on primarily (a) reducing student truancy (i.e., unexcused or unauthorized absence) and secondarily (and when included) (b) reducing delinquent behaviors? (2) Is there variability in the effectiveness of parent‐engagement programs across moderators such as gender, age, grade levels, settings, and contexts? (3) What factors (e.g., groups, settings, and contexts) explain the variability in the effectiveness of engagement programs in a multivariate framework?

Objective To determine the natural history of vocal fold cysts, by undertaking a retrospective analysis of data from a single clinical institute. Methods All patients diagnosed with vocal fold cysts were identified from January 2006 to June 2018. A total of 87 patients that elected not to have surgery or who had an interval of observation greater than 90 days prior to surgical intervention were further analyzed. The primary outcome was whether the cyst enlarged, reduced in size, resolved or ruptured. The secondary outcome measures were whether cyst characteristics (translucent or opaque by gross appearance and/or the presence of inflammation), voice therapy or duration of follow up (≤/> 300 days) had an impact upon natural history. Results There were 65 females and 22 males (47 years ±17). The mean duration of follow up was 589 days (Range 21 - 4523 days). The majority of cysts did not change (70.11%). The rest enlarged (12.64%), reduced in size (13.79%), resolved (1.15%) or ruptured (1.15%). There was no statistically significant relationship between the presence or absence of clinical signs of inflammation (P = .633) or voice therapy (P = .785) on natural history. There was an equivocal relationship between gross cyst appearance and natural history (P = .054), however there was a statistically significant relationship between the duration of follow up (P = .006) and natural history. Conclusion Most vocal fold cysts appear to remain static in size over time. About 30% change, with half of these enlarging and half shrinking. In addition to some possibility of change in size, there is a small chance of resolution or spontaneous rupture with potentially serious consequences to the voice. Level of evidence 4. Laryngoscope, 130:2202-2207, 2020.

INTRODUCTION Few studies investigate significant perioperative predictors for long-term renal allograft survival after second kidney transplant (SKT). We compared long-term survival following SKT with primary kidney transplant and determined predictors of renal allograft failure after SKT. METHODS Outcomes of all primary or second kidney transplant recipients at a national kidney transplant center between 1993 and 2017 were reviewed. The primary outcomes measurements were renal allograft survival for both first and second kidney transplants. Secondary outcome measurements were incidence of delayed graft function (DGF), incidence of acute rejection (AR), and predictors for renal allograft survival in SKT recipients. RESULTS In total, there were 392 SKTs and 2748 primary kidney transplants performed between 1993 and 2017. The 1-, 5-, and 10-year death-censored graft survival for deceased-donor recipients was 95.3%, 88.7%, and 78.2% for primary kidney transplant and 94.9%, 87.1%, and 74.9% for SKT (P = .0288). Survival of primary renal allograft

Background As many as 89% of people with Parkinson's disease (PD) develop speech disorders. Objectives This randomized controlled trial evaluated two speech treatments for PD matched in intensive dosage and high-effort mode of delivery, differing in subsystem target: voice (respiratory-laryngeal) versus articulation (orofacial-articulatory). Methods PD participants were randomized to 1-month LSVT LOUD (voice), LSVT ARTIC (articulation), or UNTXPD (untreated) groups. Speech clinicians specializing in PD delivered treatment. Primary outcome was sound pressure level (SPL) in reading and spontaneous speech, and secondary outcome was participant-reported Modified Communication Effectiveness Index (CETI-M), evaluated at baseline, 1, and 7 months. Healthy controls were matched by age and sex. Results At baseline, the combined PD group (n = 64) was significantly worse than healthy controls (n = 20) for SPL (P 0.05). For CETI-M, between-group comparisons showed greater improvements for LSVT LOUD and LSVT ARTIC than UNTXPD at 1 month (P = 0.02; P = 0.02). At 7 months, CETI-M between-group differences were not significant (P = 0.08). Within-group CETI-M improvements for LSVT LOUD were maintained through 7 months (P = 0.0011). Conclusions LSVT LOUD showed greater improvements than both LSVT ARTIC and UNTXPD for SPL at 1 and 7 months. For CETI-M, both LSVT LOUD and LSVT ARTIC improved at 1 month relative to UNTXPD. Only LSVT LOUD maintained CETI-M improvements at 7 months. © 2018 The Authors. Movement Disorders published by Wiley Periodicals, Inc. on behalf of International Parkinson and Movement Disorder Society.

Clinical trials are often designed to compare treatments on the basis of multiple outcomes. For the analysis of the treatment comparison from such a trial, in 1999, the Finkelstein-Schoenfeld test was proposed, which was a generalization of the Gehan-Wilcoxon test based on pairwise comparison of patients on a primary outcome when possible but otherwise on a secondary outcome. In 2012, Pocock and colleagues suggested an estimate based on this concept, the Win Ratio, which summarized the ratio of the number of patients who fared better versus worse on the experimental arm. However, in 2016, Oakes noted that the Win Ratio could be a function of the distribution of follow-up times of the trial. The aim of this paper is to propose an approach to representing the Win Ratio graphically in such a way that the effect of time on the estimate would be apparent. In addition, the methods are used to display the contribution of each endpoint to the composite. We apply the methods to clinical trials in cancer, cardiology, and neurology. Software is available named winRatioAnalysis in CRAN.

Aim Cardiopulmonary resuscitation (CPR) training in schools can increase the rate of bystander CPR. We assessed whether a “Quality CPR (QCPR) Classroom” can support CPR performance by students trained by a teacher who is not a CPR instructor. Methods A cluster randomized trial was undertaken to assess the effectiveness of a 50‐min Practice While Watch CPR training program enhanced by QCPR Classroom, which used 42 manikins connected by Bluetooth to real‐time feedback monitoring. Fifty‐seven students were divided into Group 1, taught by a non‐CPR‐instructor, and Group 2, taught by a CPR instructor. Psychomotor and cognitive tests were administered before and after training. Primary outcomes were post‐training compression depth and rate and percent of improvement in adequate depth, recoil, and overall score. The secondary outcome was risk improvement. Results Post‐training, Group 1 achieved 62.1 ± 7.7 mm and 118.0 ± 3.6 compressions/min whereas Group 2 achieved 57.4 ± 9.8 mm and 119.8 ± 5.4 compressions/min. The overall score improvement in percentage points was 36.4 ± 25.9% and 27.0 ± 27.7%, respectively (P ≤ 0.001 for both). The adequate depth improvement in percentage points was 22.4 ± 35.4% and 32.5 ± 40.0%, respectively (P = 0.33). Teaching by a non‐CPR instructor improved student cognitive knowledge. Conclusions Using a QCPR Classroom to enhance CPR teaching by a non‐CPR‐instructor results in similar or better outcomes compared to using a CPR instructor. Use of a Practice While Watch QCPR Classroom will provide adequate quality in preparing students for CPR., In this study, we assessed whether a “Quality CPR (QCPR) Classroom”, a cardiopulmonary resuscitation (CPR) feedback device for use in classrooms, can support CPR performance among students trained by a teacher who is not a CPR instructor. We compared CPR skills and cognitive knowledge between the group led by an experienced teacher who was not a CPR instructor and the group led by an experienced CPR teacher. The groups did not differ in improvement.

While pathologists have always played a pivotal role in clinical trials ensuring accurate diagnosis and staging, pathology data from prognostic and predictive tests are increasingly being used to enrol, stratify and randomise patients to experimental treatments. The use of pathological parameters as primary and secondary outcome measures, either as standalone classifiers or in combination with clinical data, is also becoming more common. Moreover, reporting of estimates of residual disease, termed ‘pathological complete response’, have been incorporated into neoadjuvant clinical trials. Pathologists have the expertise to deliver this essential information and they also understand the requirements and limitations of laboratory testing. Quality assurance of pathology‐derived data builds confidence around trial‐specific findings and is necessarily focused on the reproducibility of pathological data, including ‘estimates of uncertainty of measurement’, emphasising the importance of pathologist education, training, calibration and demonstration of satisfactory inter‐observer agreement. There are also opportunities to validate objective image analysis tools alongside conventional histological assessments. The ever‐expanding portfolio of clinical trials will demand more pathologist engagement to deliver the reliable evidence‐base required for new treatments. We provide guidance for quality assurance of pathology scoring and reporting in clinical trials.

Objectives This study aimed to describe how canine diabetes mellitus (CDM) is monitored in primary care practice (PCP) and to report outcomes. Design Retrospective case review. Setting PCP. Participants 40 dogs of 22 different pedigrees and five crossbreeds. Median age at diagnosis was nine years and six months (eight years six months to 10 years five months). Dogs were diagnosed with CDM between January 1, 2008 and December 30, 2012 and remained with the practice to the study end or until death. Primary and secondary outcome measures Stability achievement and death or euthanasia. Consultations for each dog were identified and recorded through records collected from the PCP (January 1, 2008 to December 30, 2012). Results A median of three consultations per dog occurred in the first month, subsequently falling to a median of one consultation every 19 days thereafter. After the first month postdiagnosis, weight and single blood glucose concentrations were most frequently recorded at 66.8 and 42 per cent of consultations respectively and a blood glucose curve was performed infrequently (17.4 per cent). Serum biochemistry was measured at 8 per cent of consultations and urine culture at only 0.8 per cent. Median survival time (MST) for all dogs was eight months (2–21 months). Eighteen dogs stabilised within three months of diagnosis and their MST was 20.5 months, (10.25–25.75 months), significantly longer than the 22 dogs not achieving stability within three months (MST 2.5 months, 0–5.5 months) (P

The primary objective is to report long-term hearing outcomes (2 years) after titanium ossiculoplasty in patients with chronic otitis media.Case series with chart review.Tertiary care hospital.In total, 156 patients with chronic otitis media undergoing titanium ossiculoplasty were included. The primary outcome measure was the long-term postoperative ABG. The stability of hearing over time was determined by comparing short-term and long-term postoperative air-bone gap (ABG). Secondary outcome measures included ΔABG, postoperative speech reception thresholds, air-conduction pure-tone average (AC PTA), word recognition scores, and percentage of patients achieving ABG ≤20 dB. Revision and extrusion rates were examined.At short-term follow-up (6 months), mean postoperative ABG was 18.4 ± 10.6 dB and AC PTA was 31.7 ± 15.2 dB; 67% of patients achieved ABG ≤20 dB. At long-term follow-up (2 years), mean ABG was 20.0 dB ± 15.4 and AC PTA was 35.3 ± 16.1 dB; 60% of patients achieved ABG ≤20. At both short- and long-term follow-up, ABG and AC PTA were significantly improved compared with preoperative values. No difference in hearing outcomes was observed when comparing partial titanium ossicular prostheses (PORPs) to total titanium ossicular prostheses (TORPs) at either short- or long-term follow-ups. In patients with both short- and long-term follow-up (n = 50), deterioration in hearing was noted (3.4 dB, P = .04). When analyzed by type of prosthesis, PORPs demonstrated statistically significant deterioration in ABG over time (4.9 dB, P = .02), while TORPs did not (2.5 dB, P = .50). The long-term extrusion rate was 3.2%.With a minimum follow-up of 2 years, titanium ossiculoplasty provides good long-term hearing results. Modest deterioration in hearing is noted over time.

The aim of this systematic literature review was to investigate whether the incorporation of antimicrobial agents into dental restorative materials truly exerts an antimicrobial effect against common cariogenic bacteria (primary outcome), and whether the inclusion of antimicrobial agents is able to prevent caries around restorations (secondary outcome). MEDLINE, via PubMed, was searched for papers published between 1980 and 30 November 2014. A total of 1126 articles were retrieved. After inclusion/exclusion assessment, 147 full text articles were read and included in the review, comprising 130 in vitro, 1 in situ, and 4 in vivo studies, as well as 12 literature reviews. In about 78% of in vitro studies, and in all identified in situ and in vivo studies, a positive antimicrobial effect had been found. However, the anticaries effect had not been tested in any of the selected studies. It was concluded that there is indeed evidence that restorative dental materials containing antimicrobial agents exert an antimicrobial effect, both in laboratory and in clinical studies. However, no evidence has been found regarding the role of these agents in preventing or controlling dental caries, or in preventing caries around restorations.

Subthalamic nucleus deep brain stimulation (STN-DBS) has revolutionized the management of disabling motor complications in Parkinson's disease. The EARLYSTIM trial applied this treatment to patients who had been experiencing motor complications for less than three years. STN-DBS significantly improved all primary and secondary outcome measures while best medical therapy failed to provide any improvement at the two-year follow-up time point. On face value these results strongly favor the application of STN-DBS far earlier than is currently applied, when patients are just beginning to experience problems with motor complications. Here we review the application of early DBS and the EARLYSTIM trial from the perspectives of clinical issues, health economics and study design and patient expectation of benefit. We conclude that the most relevant issue is not when to operate but on whom and that early is not always better. © 2014 International Parkinson and Movement Disorder Society.

Aim To evaluate the effectiveness of a stress management program to enhance the ability to cope with stress in perimenopausal women. Methods In this quasi-experimental design, a stress management program was provided to an experimental group (n = 55), while a control group (n = 42) was given an informational pamphlet. The stress management program included a short lecture, group discussion, and hands-on training in 2 h sessions once a week for 3 weeks. Participants were recruited through a public announcement. Data were collected before and after the intervention, and 1 month following the intervention. The ability to cope with stress was the primary outcome, while psychological well-being and relief of symptoms were the secondary outcomes. The primary purpose of this program is to enhance the ability to cope with stress. Therefore, the aspects of knowledge, coping flexibility, and manageability were measured in the resultant ability to cope with stress. Results Compared to the control group, knowledge in the experimental group improved positively as the primary outcome (P

Aim Many countries have guidelines recommending the use of oral zinc in acute dehydrating diarrhoea in children aged 2 months to 5 years of age, but no guidelines exist for older children. This study tested how effective existing recommendations are in children from 5 to 12 years of age. Methods Children hospitalised with acute dehydrating diarrhoea (n = 134) were randomised to receive 40 mg of oral zinc sulphate tablets or a placebo for 14 days. The primary outcome variable was the time taken for diarrhoea to stop. Secondary outcome variables included time taken for rehydration, duration of hospitalisation and recurrence of diarrhoea in the next 3 months. Results The median time for resolution of diarrhoea was 60 h in both groups. The zinc group was marginally better, but not statistically significant, for resolution (hazard ratio = 0.89, 95% CI 0.63–1.24), rehydration (hazard ratio = 0.93, 95% CI 0.66–1.32) and hospitalisation (hazard ratio = 0.94, 95% CI 0.67–1.34). The risk ratio of recurrence for zinc versus placebo (95% CI) was 0.65 [0.37–1.23] [p = 0.11]. Conclusion Daily zinc supplements (40 mg for 14 days) in children aged 5–12 years with acute dehydrating diarrhoea did not shorten the duration of diarrhoea or reduce subsequent episodes. Further adequately sized, community-based trials are needed.

Aim Enhanced recovery after surgery (ERAS) programmes have been shown to reduce length of stay and peri-operative morbidity. However, there are comparatively few data on their cost effectiveness. The object of this systematic review was to appraise the current literature to determine the cost effectiveness of ERAS and to characterize how cost is reported and evaluated. Method An electronic database search identified studies comparing ERAS with standard peri-operative care in colorectal surgery where an evaluation of cost effectiveness was a primary or secondary outcome. Cost data were converted to euros to enable a more standardized comparison of the studies. There were no limits on study design. Results Seven articles were included in the analysis. The reporting and evaluation of cost data were inconsistent. Reported cost for ERAS ranged from €1989 to €12 805 per patient. Although not all statistically significant, all studies demonstrated cost reductions with ERAS compared with non-ERAS although they were highly variable, ranging from €153 to €6537 per patient. Conclusion Although the review has shown ERAS to be cost effective, there are some important inconsistencies and deficiencies regarding the reporting of data. Authors should therefore be encouraged to report cost data to supplement the literature detailing clinical efficacy.

Treatment of intrabony defects is an important therapeutic goal of periodontal therapy. The goal of this consensus report was to critically appraise the evidence for the available approaches for promoting periodontal regeneration in intrabony defects. In addition to evaluating the effectiveness of new regenerative approaches for intrabony defects, recommendations for future research were defined for this area.A systematic review was conducted using computerized searches of PubMed and Cochrane databases, supplemented with screening of references in original reports, review articles, and a hand search in selected journals. All searches were focused on regenerative approaches with histologic evidence of periodontal regeneration (proof of principle), clinical trials, and case reports. For purposes of analysis, change in intrabony defect fill was considered the primary outcome variable, with change in clinical attachment as a secondary outcome. The SORT (Strength of Recommendation Taxonomy) grade was used to evaluate the quality and strength of the evidence. During the consensus meeting, the group agreed on the outcomes of the systematic review, pertinent sources of evidence, clinical recommendations, and areas requiring future research.The systematic review, which was conducted for the consensus conference, evaluated the effectiveness of the use of biologics for the treatment of intrabony defects. Enamel matrix derivative (EMD) and recombinant human platelet-derived growth factor-BB (rhPDGF-BB) with β-tricalcium phosphate were shown to be efficacious in regenerating intrabony defects. The level of evidence is supported by multiple studies documenting effectiveness. The clinical application of biologics supports improvements in clinical parameters comparable with selected bone replacement grafts and guided tissue regeneration (GTR). Factors negatively affecting regeneration included smoking and excessive tooth mobility.Periodontal regeneration in intrabony defects is possible on previously diseased root surfaces, as evidenced by a gain in clinical attachment, decreased pocket probing depth, gain in radiographic bone height, and overall improvement in periodontal health. These clinical findings are consistent with available histologic evidence. Clinical improvements can be maintained over long periods (10 years). Although bone replacement grafts have been the most commonly investigated modality, GTR, biologics, and combination therapies have also been shown to be effective. Future research should emphasize patient-reported outcomes, individual response differences, and emerging technologies to enhance treatment results.Early management of intrabony defects with regenerative therapies offers the greatest potential for successful periodontal regeneration. The clinical selection and application of a regenerative therapy or combination of therapies for periodontal regeneration should be based on the clinician's experiences and understanding of the regenerative biology and technology. This decision-making process should take into consideration the potential adverse influence of factors, such as smoking, poor oral hygiene, tooth mobility, and defect morphology, on regeneration. Management should be coupled with an effective maintenance program for long-term success.

Aim Patients with Alzheimer's disease (AD) and cerebrovascular disease (CVD) show greater attentional deficits compared with AD patients without CVD. The aim of the present study was to investigate the effect of galantamine on attention in AD patients with CVD. Methods In this open trial, 1512 patients with AD and CVD were recruited from 71 nationwide hospitals. The patients were given galantamine for 16 weeks. The primary outcome measure was the score on the Attention Questionnaire Scale (AQS), which measures the patients’ attention in their daily lives. The secondary outcome measures were the scores on the Korean Mini-Mental State Examination, the Clinical Dementia Rating scale and the Global Deterioration Scale. Efficacy measures were calculated both at baseline and at the end of the treatment (week 16). Results The responders rate on the AQS (change of the AQS from baseline >0) was 60.6% in AD patients with CVD. At the end of the treatment, both the AQS (15.0 ± 5.7 vs 16.3 ± 5.8, P

objectives Bihar, the poorest state in India, concentrates most of the visceral leishmaniasis (VL) cases in the country. A large proportion of the poor rural communities where VL is endemic are marginalized by their socio-economic status, intrinsically related to the caste system. In this study, we evaluated whether people from low socio-economic strata had difficulties accessing VL treatment in Bihar. As a secondary outcome, we evaluated whether people delaying their VL treatment had poorer clinical indicators at admission. methods Data on 2187 patients with VL treated by Medecins Sans Frontieres (MSF) in Vaishali district from July 2007 to December 2008 were analysed. Patients who reported having onset of symptoms ‡8 weeks before admission were defined as 'late presenters'. Logistic regression models were used to evaluate whether low castes had higher risk to be 'late presenters' compared to the rest of castes and whether 'late presenters' had poorer indicators at admission (i.e. haemoglobin level, spleen size). results After adjusting for age, gender and distance to VL treatment facility, Mushars (the lowest caste in Bihar) had twice the odds to be 'late presenters' compared to the rest of castes (OR 2.05, 95% CI: 1.24-2.38). Subjects that had VL symptoms for ‡8 weeks had a larger spleen and lower haemoglobin level than those that were treated earlier. conclusion Low castes have poor access to VL treatment in Bihar, and late presenters have poorer clinical indicators at admission. These findings have implications at individual and community levels and should stimulate targeted VL control programmes to ensure that marginalized communities in Bihar are properly treated.

Background Reports on controlled trials on the efficacy and tolerability of sulfonated shale oils in atopic eczema are not available so far. The aim of this study was to investigate whether topically applied, specially prepared pale sulfonated shale oil (PSSO) cream is capable of improving symptoms/signs of mild to moderate atopic eczema in children more efficaciously than a corresponding vehicle cream. Patients and methods A total of 99 children suffering from mild to moderate atopic eczema were enrolled in this multicentre, randomized, vehicle-controlled study. Verum or vehicle cream was applied to the affected skin area three times a day over 4 weeks. As the primary outcome parameter served the reduction of the total score after 4 weeks of treatment, compared with the initial examination. Secondary outcome parameters were addressed as well. Tolerability was judged by investigators and patients/parents, and adverse events were documented. Results After 4 weeks of treatment, the total score declined from 13.4 ± 3.7 to 4.5 ± 7.4 score points in the verum group and from 13.0 ± 3.1 to 11.7 ± 8.6 score points in the vehicle group (P

To compare postoperative pain between monopolar cautery tonsillectomy and harmonic scalpel tonsillectomy (HST).Randomized controlled trial using paired organs.Community hospital with academic affiliation.One hundred and fourteen consecutive patients six years of age or older undergoing tonsillectomy for indications of hypertrophy or recurrent infection.For each subject, monopolar cautery tonsillectomy was performed by four senior surgeons on one side and HST was performed on the other side. Allocation of technique to side was randomized and revealed to the surgeon at the start of the operation. Validated visual analog pain scales were used to quantify pain at rest and with swallowing for each side and were completed daily for 14 days. All subjects were prescribed weight-equivalent doses of analgesics. Secondary outcome measures included postoperative complications (hemorrhage and readmission).Pairwise comparisons of pain scores revealed no significant difference between monopolar cautery tonsillectomy and HST (P0.05).Subjects undergoing monopolar cautery tonsillectomy do not experience increased postoperative pain in comparison to HST.

The central research question addressed in this paper is 'How do companies and their auditors resolve important audit issues?' In-depth interviews are conducted with the audit partners and finance directors of a varied group of six major UK listed companies who had recently experienced audit interactions involving 22 significant accounting issues. A grounded theory model is developed of the negotiation process and the factors that influence the nature of the outcome of interactions. This model identifies, as principal analytical categories, a range of general relationship factors and specific accounting issue factors that influence aspects of the negotiation process. These aspects include the parties involved, the strategies adopted, the quality of the financial reporting outcome and the ease with which it is achieved. A secondary outcome of the research is that distinct categories of audit engagement partner are identified, termed the crusader, the safe pair of hands, the accommodator and the truster.

Background: Increasingly, biomarkers are being incorporated into the research design of clinical trials on medications to reduce drinking in alcoholics. To date, however, there has been little analysis of the unique roles that biomarkers can play in such investigations or of the practical and conceptual considerations that surround their best use in this context. Methods: Clinical trials of alcoholism medications published between 1985 and the present were abstracted to determine how biomarkers were used and how changes in them related to self-report measures of drinking. Results: Six uses of biomarkers were identified: determination of subjects to be included or excluded in the trial; description of baseline sample characteristics; primary and secondary outcome assessment; corroboration of self-reports of drinking status; specification of patients likely to respond to the medication; and evaluation of drug safety. Conclusion: Use of biomarkers in such studies appears warranted, particularly as an objective source of information on treatment efficacy that can be considered with patient self-report measures of drinking status. Biomarkers related to liver functioning also can assist in determination of drug safety for medications metabolized by the liver.

Objectives/Hypothesis In 1998 Eavey described a new inlay technique for tympanoplasty in the pediatric age group using a cartilage graft through a transcanal approach. This technique was found to be effective and comfortable (no external canal incisions or ear packing). This study evaluated the efficacy of modified-inlay cartilage tympanoplasty compared with the conventional underlay tympanoplasty. Study Design Randomized clinical trial. Methods Patients were enrolled from December 1998 to March 2000. Seventy tympanoplasties were done in adults with medium-sized tympanic membrane (TM) perforations: 34 inlay tympanoplasties and 36 underlay tympanoplasties (control group). The main outcome measures were the “take rate” on the 30th postoperative day and the audiometric result at the second postoperative month. Secondary outcome measures include subjective postoperative hearing, postoperative pain, duration of surgery, and cost of the procedures. Results The “take rate” did not differ between groups on the 30th postoperative day (88.2% in the inlay tympanoplasty group vs 86.1% in the underlay tympanoplasty group;P = .8). After a mean follow-up of 7.5 ± 3.8 months (range, 3–16 mo), the “take rate” was 85.3% in the inlay tympanoplasty group and 83.3% in the underlay tympanoplasty group (P = .8). In the inlay tympanoplasty group there was closure of the air–bone gap (ABG) to within 10 dB in 64.7% and to within 20 dB in 94.1%. The corresponding numbers to underlay tympanoplasty were 75% and 97.2%. In only 2 cases (5.9%) in the inlay tympanoplasty group and in 1 case (2.8%) in the underlay tympanoplasty group the ABG was greater than 20 dB. No audiometric difference was observed between groups (P = .6). Most patients in the inlay tympanoplasty group reported immediate improvement in their hearing (P

Objective To determine the noun for ‘women who attend antenatal clinics’ that is most accepted by the women themselves. Design Cross sectional study. Setting Consultant-led antenatal clinics in Cornwall. Population All women attending consultant-led antenatal clinics over a two-month period. Methods The women were surveyed by written questionnaire. Main outcome measures The first, second and third choices of descriptions offered to women attending antenatal clinics. Secondary outcome measures include the relation of maternal age, gestation, civil status, occupation and obstetric history to the individual's choice of description. Results Questionnaires were received from 446 women, constituting 13% of the antenatal population of Cornwall. Their median age was 28 years and median gestation 22 weeks; 255 (57%) had one or more children and 289 (65%) were married. The most popular choice of description was ‘patient’ (39% of first choices made), whereas the most accepted description was ‘pregnant woman’ (26% of totalled second and third choices). While women who selected ‘patient’ as first choice were slightly younger (mean 27.5 years) than the remaining women (mean 28.4 years), the choice of ‘pregnant woman’ was not related to any of the other recorded characteristics of the respondents. Commercial terms that consistently were selected least included ‘client’, ‘consumer’ and ‘customer’. Conclusion Some professional bodies and government organisations have criticised the use of the term ‘patient’ to describe antenatal women. In this, the largest study to investigate what the women themselves would choose, ‘patient’ is the most favoured term.

Purpose To investigate the safety and efficacy of Ologen (OLO) implant (Kestrel Medical Ltd, Broadstone, Dorset) for trabeculectomy revision surgery versus trabeculectomy revision with Mitomycin C 0.3mg/ml. Methods This study was a prospective pilot trial with 6-months follow-up. Fourteen glaucoma patients underwent trabeculectomy revision with OLO. Primary outcome measures included postoperative target intraocular pressure (IOP), with or without medications. Secondary outcome measures included bleb evaluation, OCT imaging, number of medications, number of postoperative interventions and adverse events. All patients were reviewed postoperatively at day 1, 7, week 3, 7, 12 and 24. Results The mean pre-operative IOP was 22.3 (±4.1 mmHg), mean postoperative IOP was 14 (±5.8 mmHg). IOP reduction from baseline was statistically significant (p

I WOULD like to congratulate the authors of the paper on whole-flock metaphylactic treatment of contagious ovine digital dermatitis (CODD) with tilmicosin (Angell and others 2016) for performing what must have been a vast and complex undertaking. However, there are a couple of issues that the study brings up which are skated over in the published paper. First, and highly commendably, the authors undertook a prestudy power analysis. However, this was not a power analysis for their primary outcome – elimination; it was for a secondary outcome – reduction in prevalence (an outcome for which results weren't detailed in the abstract). While under some circumstances elimination per se may not suit a power analysis (although in this case comparing proportions of farms with disease at study end …

Purpose To compare the efficacy of neovascular AMD(NAMD) treatment options by monthly Lucentis(L)(monotherapy), combination therapy utilizing RF-PDT(P), and Lucentis combined with Kenalog(LK). Methods IRB-approved retrospective chart review of therapies administered only as-needed over 20 months. Inclusion criteria: active primary/recurrent subfoveal or juxtafoveal CNV (all types); Snellen BCVA ≥20/400. Exclusion criteria: f/u LK>PK, occurring 91%, 80%, 75%, 60%, respectively. 14% L gained ≥30 letters. 20% PK lost ≥30 letters. Leakage resolved greater for L>PA±K>LK>PK, occurring 86%, 80%, 69%, 40%, respectively. Conclusion At intermediate-term f/u, Lucentis monotherapy administered only as-needed had results similar to larger studies and was the most effective in maintaining or improving VA in NAMD. Lucentis monotherapy had the greatest leakage resolution and treatment-free interval. RF-PDT with Avastin was more effective than with Kenalog alone. Kenalog supplementation to Lucentis unlikely provided added benefit.

ObjectiveSurgiSIS is a new bioactive material derived from porcine small intestinal mucosa (SIS). This acellular, easily absorbable collagen matrix promotes early and new vessel growth, and provides scaffolding for the remodeling tissues. This is an inexpensive and ready-to-use alternative to autologous grafts. We evaluated the efficacy, safety, and surgery time of SIS myringoplasty, and compared clinical outcomes with patient's temporalis fascia (PTF) repair in children.MethodsProspective, 2-group (SIS, and PTF) randomized, blinded study in a tertiary-care pediatric institution. 82 children for whom tympanic membrane (TM) repair was indicated were randomly assigned to receive either SIS or PTF myringoplasty. Patients and examining physician were blinded to surgical modality. Primary outcomes were the healing of the TM and surgical time; secondary outcome was presence of any reaction or inflammation of the TM. 2-year follow-up was obtained in all enrolled children.ResultsA total of 82 TM (43 in the SIS an...