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Lu JH, Wei H, Zhang Y, Fei F, Huang HY, Dong QJ, Chen J, Ao DQ, Chen L, Li TY, Li Y, Dai Y. Effects of remote support courses on parental mental health and child development in autism: A randomized controlled trial. World J Psychiatry 2024; 14:1892-1904. [PMID: 39704371 PMCID: PMC11622010 DOI: 10.5498/wjp.v14.i12.1892] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 08/28/2024] [Revised: 09/22/2024] [Accepted: 10/11/2024] [Indexed: 11/27/2024] Open
Abstract
BACKGROUND Sustaining the mental health of autistic children's parents can be demanding. AIM To determine the effect of remote support courses on the mental health of parents and the development of autistic children. METHODS Parents of 140 autistic children were randomly assigned to two groups receiving a 2-week intervention: The control group received caregiver-mediated intervention (CMI); the experimental group received CMI with remote family psychological support courses (R-FPSC). The Parenting Stress Index-Short Form, Parenting Sense of Competence Scale, Generalized Anxiety Disorder-7, and Patient Health Questionnaire-9 were used to measure parents' mental health. The Childhood Autism Rating Scale and Gesell Developmental Schedules were used to evaluate children's development. RESULTS Improved parenting stress, sense of competence, depression, and anxiety were found in both groups, but improvements in parenting stress (81.10 ± 19.76 vs 92.10 ± 19.26, P < 0.01) and sense of competence (68.83 ± 11.23 vs 63.91 ± 10.86, P < 0.01) were greater in the experimental group, although the experimental group showed no significant reduction in depression or anxiety. Children's development did not differ significantly between the groups at follow-up; however, experimental group parents exhibited a short-term increase in training enthusiasm (12.78 ± 3.16 vs 11.57 ± 3.15, P < 0.05). CONCLUSION Integrating R-FPSC with CMI may be effective in reducing parenting stress, enhancing parents' sense of competence, and increasing parents' training enthusiasm.
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Affiliation(s)
- Jia-Hui Lu
- Growth, Development and Mental Health Center of Children and Adolescents, Children’s Hospital of Chongqing Medical University, Chongqing Key Laboratory of Child Neurodevelopment and Cognitive Disorders, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing 401146, China
| | - Hua Wei
- Growth, Development and Mental Health Center of Children and Adolescents, Children’s Hospital of Chongqing Medical University, Chongqing Key Laboratory of Child Neurodevelopment and Cognitive Disorders, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing 401146, China
| | - Yu Zhang
- Growth, Development and Mental Health Center of Children and Adolescents, Children’s Hospital of Chongqing Medical University, Chongqing Key Laboratory of Child Neurodevelopment and Cognitive Disorders, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing 401146, China
| | - Fan Fei
- Growth, Development and Mental Health Center of Children and Adolescents, Children’s Hospital of Chongqing Medical University, Chongqing Key Laboratory of Child Neurodevelopment and Cognitive Disorders, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing 401146, China
| | - Hai-Yan Huang
- Growth, Development and Mental Health Center of Children and Adolescents, Children’s Hospital of Chongqing Medical University, Chongqing Key Laboratory of Child Neurodevelopment and Cognitive Disorders, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing 401146, China
| | - Qiu-Jun Dong
- Growth, Development and Mental Health Center of Children and Adolescents, Children’s Hospital of Chongqing Medical University, Chongqing Key Laboratory of Child Neurodevelopment and Cognitive Disorders, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing 401146, China
| | - Jing Chen
- Growth, Development and Mental Health Center of Children and Adolescents, Children’s Hospital of Chongqing Medical University, Chongqing Key Laboratory of Child Neurodevelopment and Cognitive Disorders, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing 401146, China
| | - Dong-Qin Ao
- Growth, Development and Mental Health Center of Children and Adolescents, Children’s Hospital of Chongqing Medical University, Chongqing Key Laboratory of Child Neurodevelopment and Cognitive Disorders, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing 401146, China
| | - Li Chen
- Growth, Development and Mental Health Center of Children and Adolescents, Children’s Hospital of Chongqing Medical University, Chongqing Key Laboratory of Child Neurodevelopment and Cognitive Disorders, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing 401146, China
| | - Ting-Yu Li
- Growth, Development and Mental Health Center of Children and Adolescents, Children’s Hospital of Chongqing Medical University, Chongqing Key Laboratory of Child Neurodevelopment and Cognitive Disorders, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing 401146, China
| | - Yan Li
- Growth, Development and Mental Health Center of Children and Adolescents, Children’s Hospital of Chongqing Medical University, Chongqing Key Laboratory of Child Neurodevelopment and Cognitive Disorders, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing 401146, China
| | - Ying Dai
- Growth, Development and Mental Health Center of Children and Adolescents, Children’s Hospital of Chongqing Medical University, Chongqing Key Laboratory of Child Neurodevelopment and Cognitive Disorders, National Clinical Research Center for Child Health and Disorders, Ministry of Education Key Laboratory of Child Development and Disorders, Chongqing 401146, China
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Sansosti LE, Joseph R, Grambart S. Teaching Science to the Next Generation. Clin Podiatr Med Surg 2024; 41:367-377. [PMID: 38388133 DOI: 10.1016/j.cpm.2023.06.014] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 02/24/2024]
Abstract
Teaching science to the next generation begins with foundations laid in podiatric medical school. Interest and immersion in research continues to develop through residency as trainees prepare for cases, participate in journal clubs, present posters and articles, and attend conferences. Having adequate training is essential to production of quality research. Although challenges and barriers exist, numerous resources are available at all levels of practice to guide those who are interested in contributing to the body of literature that supports the profession. Ensuring a robust pipeline of future clinician scientists is critical to the future of the profession.
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Affiliation(s)
- Laura E Sansosti
- Department of Surgery, Temple University School of Podiatric Medicine, 148 North 8th Street, Philadelphia, PA 19107, USA; Department of Biomechanics, Temple University School of Podiatric Medicine, 148 North 8th Street, Philadelphia, PA 19107, USA.
| | - Robert Joseph
- Robert Joseph DPM, PHD, FACFAS,D.ABFAS, Gainesville, FL, USA
| | - Sean Grambart
- Des Moines University College of Podiatric Medicine and Surgery, 3200 Grand Avenue, Des Moines, IA 50312, USA
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Thakur V, Mittal S, Tewari S, Kamboj M, Duhan J, Sangwan P, Kumar V, Gupta A. Comparative histological evaluation of two PRF formulations (PRF High and PRF Medium) on quality of life and healing outcome of apicomarginal defects: A randomized clinical trial. J Craniomaxillofac Surg 2023; 51:166-177. [PMID: 36894343 DOI: 10.1016/j.jcms.2023.02.004] [Citation(s) in RCA: 2] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/06/2022] [Revised: 01/28/2023] [Accepted: 02/15/2023] [Indexed: 02/25/2023] Open
Abstract
The objective of this randomized clinical trial was to investigate the effects of two PRF formulations (PRF High and PRF Medium) on quality of life and healing outcome (2D and 3D) of apicomarginal defects. Patients presenting with endodontic lesions and concomitant periodontal communication were randomly allocated to PRF High and PRF Medium groups. The treatment protocol in each group included a periapical surgical procedure with placement of PRF clot and membrane in the bony defect and on the denuded root surface, respectively. Quality of life was assessed for 1 week after surgery following a modified version of the patient's perception questionnaire. Postoperative pain was assessed using a visual analog scale. Clinical and radiographic evaluations were performed using Rud and Molven 2D criteria and Modified PENN 3D criteria. Buccal bone formation was assessed using sagittal and corresponding axial sections in CBCT. Histological analysis was performed using hematoxylin and eosin (H and E) staining and attaching primary antibodies to tissue sections. In total, 40 patients were enrolled in the trial (N = 20 per group). PRF Medium group patients reported significantly less swelling on the 1st (p = 0.036), 2nd (p = 0.034), and 3rd (p = 0.023) days, and average pain on the 2nd (p = 0.031), 3rd (p = 0.03), and 4th (p = 0.04) days postoperatively. The difference in success rate for periapical healing was non-significant between the PRF Medium group (89.5%) and PRF High group (90%), in both 2D and 3D imaging (p = 0.957). The formation of buccal bone was observed in five cases (26.3%) and four cases (20%) in the PRF Medium and PRF High groups, respectively, with a non-significant difference (p = 0.575). PRF Medium clots had a loose fibrin structure with a significantly higher number of neutrophils (473.79 ± 82.89 per mm2) than PRF High clots, which had a dense structure and fewer neutrophils (253.15 ± 63.86 per mm2) (p = 0.001). Autologous platelet concentrates (APCs) promoted satisfactory periapical healing, with no significant difference between the groups. Within the limitations of the study, it seems that PRF Medium should be preferred over PRF High when the patients' quality of life is the priority.
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Affiliation(s)
- Vidhi Thakur
- Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences Rohtak (Haryana), India
| | - Shweta Mittal
- Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences Rohtak (Haryana), India.
| | - Sanjay Tewari
- Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences Rohtak (Haryana), India
| | - Mala Kamboj
- Department of Oral Pathology and Microbiology, Post Graduate Institute of Dental Sciences Rohtak (Haryana), India
| | - Jigyasa Duhan
- Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences Rohtak (Haryana), India
| | - Pankaj Sangwan
- Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences Rohtak (Haryana), India
| | - Vinay Kumar
- Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences Rohtak (Haryana), India
| | - Ambika Gupta
- Department of Oral Medicine and Radiology, Post Graduate Institute of Dental Sciences Rohtak (Haryana), India
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Taladrid D, Zorraquín‐Peña I, Molinero N, Silva M, Manceñido N, Pajares R, Bartolomé B, Moreno‐Arribas MV. Polyphenols and Ulcerative Colitis: An Exploratory Study of the Effects of Red Wine Consumption on Gut and Oral Microbiome in Active-Phase Patients. Mol Nutr Food Res 2022; 66:e2101073. [PMID: 35633101 PMCID: PMC9787944 DOI: 10.1002/mnfr.202101073] [Citation(s) in RCA: 5] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/27/2021] [Revised: 05/09/2022] [Indexed: 12/30/2022]
Abstract
SCOPE This paper explores the effects of moderate red wine consumption on the clinical status and symptomatology of patients with ulcerative colitis (UC), including the study of the oral and intestinal microbiome. METHODS AND RESULTS A case control intervention study in UC patients is designed. Intervention patients (n = 5) consume red wine (250 mL day-1 ) for 4 weeks whereas control patients (n = 5) do not. Moderate wine consumption significantly (p < 0.05) improves some clinical parameters related to serum iron, and alleviates intestinal symptoms as evaluated by the IBDQ-32 questionnaire. 16S rRNA gene sequencing indicate a non-significant (p > 0.05) increase in bacterial alpha diversity after wine intervention in both saliva and fecal microbiota. Additional comparison of taxonomic data between UC patients (n = 10) and healthy subjects (n = 8) confirm intestinal dysbiosis for the UC patients. Finally, analysis of fecal metabolites (i.e., phenolic acids and SCFAs) indicates a non-significant increase (p > 0.05) for the UC patients that consumed wine. CONCLUSIONS Moderate and regular red wine intake seems to improve the clinical status and symptoms of UC patients in the active phase of the disease. However, studies with a greater sample size are required to achieve conclusive results.
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Affiliation(s)
- Diego Taladrid
- Institute of Food Science Research (CIAL)CSIC‐UAM, c/Nicolás Cabrera 9Madrid28049Spain
| | - Irene Zorraquín‐Peña
- Institute of Food Science Research (CIAL)CSIC‐UAM, c/Nicolás Cabrera 9Madrid28049Spain
| | - Natalia Molinero
- Institute of Food Science Research (CIAL)CSIC‐UAM, c/Nicolás Cabrera 9Madrid28049Spain
| | - Mariana Silva
- Institute of Food Science Research (CIAL)CSIC‐UAM, c/Nicolás Cabrera 9Madrid28049Spain
| | - Noemi Manceñido
- Hospital Universitario “Infanta Sofia”, P.° de Europa34, 28703 San Sebastián de los ReyesMadridSpain
| | - Ramón Pajares
- Hospital Universitario “Infanta Sofia”, P.° de Europa34, 28703 San Sebastián de los ReyesMadridSpain
| | - Begoña Bartolomé
- Institute of Food Science Research (CIAL)CSIC‐UAM, c/Nicolás Cabrera 9Madrid28049Spain
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Xavier-Santos D, Scharlack NK, Pena FDL, Antunes AEC. Effects of Lacticaseibacillus rhamnosus GG supplementation, via food and non-food matrices, on children's health promotion: A scoping review. Food Res Int 2022; 158:111518. [PMID: 35840226 DOI: 10.1016/j.foodres.2022.111518] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/26/2022] [Revised: 06/11/2022] [Accepted: 06/13/2022] [Indexed: 11/04/2022]
Abstract
The literature considers children both a risk group for administering probiotic strains and one of the populations that can most benefit from it. Due to the health benefits associated to probiotic supplementation, this scope review sought to formulate a critical evaluation of how Lacticaseibacillus rhamnosus GG, carried in food and non-food matrices, and experimental design may affect the health promotion of infants and children. In this study, a literature search was conducted in three scientific databases: PubMed, Web of Science, and SciELO to retrieve research, published in English or Spanish, which administered L. rhamnosus GG to infants and children with any disease or in eutrophic condition. Three reviewers with an expert supervision screened 540 articles, published between 2001 and 2022, which were retrieved from the databases. The data extracted was compiled and shown in this scoping review. In total, was included, after criteria observation, 44 articles in this review. Intestinal disorders were the most frequent outcome in these studies (36.4%) and capsules, the most common vehicle for administering the probiotic strain (40.9%). Probiotic strain dose ranged from 105 to 1012 cfu/dose of L. rhamnosus GG and intervention length extended from one to more than 6 months. Food matrix showed health effects in 57.1% of the clinical trials and non-food matrix 46.7%, which indicates that the health-promoting effect of the probiotic GG strain may be equivalent between the two forms of delivery. However, the highly heterogeneous experimental designs prevent further analysis and a systematic review and meta-analysis is recommended to address just the outcomes of studies and achieve data homogeneity in order to determine which vehicle is the most suitable for health promoting.
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Affiliation(s)
- Douglas Xavier-Santos
- School of Applied Sciences (FCA), State University of Campinas, 300 Pedro Zaccaria St, 13484-350 Limeira, SP, Brazil
| | - Nayara Kastem Scharlack
- School of Applied Sciences (FCA), State University of Campinas, 300 Pedro Zaccaria St, 13484-350 Limeira, SP, Brazil
| | - Fabíola de Lima Pena
- School of Applied Sciences (FCA), State University of Campinas, 300 Pedro Zaccaria St, 13484-350 Limeira, SP, Brazil
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Wong WCP, Chow SL. Evaluation on the effectiveness on the implementation of WHO caregiver skills training (CST) programme in Hong Kong: a randomised controlled trial protocol. BMJ Open 2022; 12:e054099. [PMID: 35725254 PMCID: PMC9214403 DOI: 10.1136/bmjopen-2021-054099] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/29/2022] Open
Abstract
INTRODUCTION This protocol delineates the research design and analytical framework used to evaluate the effectiveness of the WHO-CST (CST, caregiver skills training) in Hong Kong. The WHO-CST aims to enhance the caregiver skills of parents of children with potential autism spectrum disorders (ASD) and/or developmental delays. METHODS AND ANALYSIS In this study, 130 eligible caregiver-child dyads were recruited and randomly assigned to the experimental and wait-list-control groups. A randomised controlled trial design was adopted to compare the changes between the two groups regarding caregivers' skills, knowledge and practices when interacting with their children with impairments due to ASD. Assessments were conducted before, immediately after and 1 month after the completion of the WHO-CST programme. The primary measurement tool was the joint engagement rating inventory developed by WHO experts to gauge how parents engage their children. A 10-min video recording of their dyadic interaction and behaviours in a defined play setting was used for the measurement. A set of other measurements of caregivers' knowledge, confidence and experience of using the caregiving skills were also measured. ETHICS AND DISSEMINATION Ethics approval was received from the Human Research Ethics Committee (EA1901033), The University of Hong Kong. The final findings of this study will be disseminated through public reports, peer-reviewed publication or at a conference launched for the WHO-CST programme. TRIAL REGISTRATION NUMBER ChiCTR2000034585.
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Affiliation(s)
- Wai-Ching Paul Wong
- Department of Social Work and Social Administration, University of Hong Kong Faculty of Social Sciences, Hong Kong
| | - Siu-Lun Chow
- Department of Social Work and Social Administration, University of Hong Kong Faculty of Social Sciences, Hong Kong
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Alsagheir A, Koziarz A, Belley-Côté EP, Whitlock RP. Expertise-based design in surgical trials: a narrative review. Can J Surg 2021; 64:E594-E602. [PMID: 34759044 PMCID: PMC8592777 DOI: 10.1503/cjs.008520] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Accepted: 11/17/2020] [Indexed: 12/29/2022] Open
Abstract
Randomized controlled trials (RCTs) are the most robust study design for evaluating the safety and efficacy of a therapeutic intervention. However, their internal validity are at risk when evaluating surgical interventions. This review summarizes existing expertise- based trials in surgery and related methodological concepts to guide surgeons performing this work. We provide caseloads required to reach the learning curve for various surgical interventions and report criteria for expertise from published and unpublished expertise-based trials. In addition, we review design and implementation concepts of expertise-based trials, including recruitment of surgeons, crossover, ethics, generalizability, sample size and definitions for learning curve. Several RCTs have used an expertise-based design. We found that the majority of definitions used for expertise were vague, heterogeneous, and inconsistent across trials evaluating the same surgical intervention. Statistical methods exist to adjust for the learning curve; however, there is limited guidance. We developed the following criteria for surgical expertise for future trials: 1) decide on the proxy to be used for the learning curve, and 2) assess eligible surgeons by comparing their performance to the previously defined expertise criteria.
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Affiliation(s)
- Ali Alsagheir
- From the Division of Cardiac Surgery, Department of Surgery, McMaster University, Hamilton, Ont. (Alsagheir, Whitlock); the Faculty of Medicine, University of Toronto, Toronto, Ont. (Kozirarz); the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ont. (Belley-Côté, Whitlock); and the Department of Medicine, McMaster University, Hamilton, Ont. (Belley-Côté)
| | - Alex Koziarz
- From the Division of Cardiac Surgery, Department of Surgery, McMaster University, Hamilton, Ont. (Alsagheir, Whitlock); the Faculty of Medicine, University of Toronto, Toronto, Ont. (Kozirarz); the Population Health Research Institute, McMaster University and Hamilton Health Sciences, Hamilton, Ont. (Belley-Côté, Whitlock); and the Department of Medicine, McMaster University, Hamilton, Ont. (Belley-Côté)
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Domb BG, Sabetian PW. The Blight of the Type II Error: When No Difference Does Not Mean No Difference. Arthroscopy 2021; 37:1353-1356. [PMID: 33581304 DOI: 10.1016/j.arthro.2021.01.057] [Citation(s) in RCA: 11] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/20/2021] [Revised: 01/26/2021] [Accepted: 01/28/2021] [Indexed: 02/02/2023]
Abstract
Much focus in research has been given to minimizing type I errors, where we incorrectly conclude that there is a difference between 2 treatments or populations. In contrast, our standard scientific method and power analysis allows for a much greater rate of type II errors, in which we fail to show a difference when, in fact, one exists (≥20% rate of type II errors vs ≤5% rate of type I errors). Additional factors that can cause type II errors may propel their prevalence to well in excess of 20%. Failure to reject the null hypothesis may be a tolerable outcome in a certain proportion of studies. However, type II errors may become dangerous when the conclusions of a study overreach, incorrectly stating that there is no difference, when, in fact, a difference exists. Type II errors resulting in overreaching conclusions may impede incremental advances in our field, as the advantages of small improvements may go undetected. To avert this danger in studies that fail to meet statistical significance, we as researchers (20% or more, vs 5% for type I errors) be precise in our conclusions stating simply that the null hypothesis could not be rejected.
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Affiliation(s)
- Benjamin G Domb
- American Hip Institute, Chicago, Illinois, U.S.A.; American Hip Institute Research Foundation, Chicago, Illinois, U.S.A.; AMITA Health St. Alexius Medical Center, Hoffman Estates, Illinois, U.S.A..
| | - Payam W Sabetian
- American Hip Institute Research Foundation, Chicago, Illinois, U.S.A
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Al-Mekhlafi A, Becker T, Klawonn F. Sample size and performance estimation for biomarker combinations based on pilot studies with small sample sizes. COMMUN STAT-THEOR M 2020. [DOI: 10.1080/03610926.2020.1843053] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.2] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/16/2022]
Affiliation(s)
- Amani Al-Mekhlafi
- Department of Biostatistics, Helmholtz Centre for Infection Research, Braunschweig, Germany
| | | | - Frank Klawonn
- Department of Biostatistics, Helmholtz Centre for Infection Research, Braunschweig, Germany
- Department of Computer Science, Ostfalia University of Applied Sciences, Wolfenbuttel, Germany
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Arya S, Duhan J, Tewari S, Sangwan P, Ghalaut V, Aggarwal S. Healing of Apical Periodontitis after Nonsurgical Treatment in Patients with Type 2 Diabetes. J Endod 2017; 43:1623-1627. [PMID: 28803674 DOI: 10.1016/j.joen.2017.05.013] [Citation(s) in RCA: 46] [Impact Index Per Article: 5.8] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/06/2016] [Revised: 04/20/2017] [Accepted: 05/26/2017] [Indexed: 12/15/2022]
Abstract
INTRODUCTION The purpose of this prospective study was to compare the success of primary root canal treatment between type 2 diabetic and nondiabetic patients and to investigate the effect of periapical healing on glycated hemoglobin (HbA1c) in type 2 diabetic patients with apical periodontitis. METHODS Sixty mandibular molars with necrotic pulps and apical radiolucency (size ≥ 2 mm × 2 mm) were included in the study. Based on the HbA1c levels, patients were divided into 2 groups: type 2 diabetic (HbA1c ≥6.5%) and nondiabetic (HbA1c <6.5%). Forty-six teeth were evaluated at the 12-month follow-up time period. The primary outcome measure was the change in apical bone density as determined by the periapical index. RESULTS Both the diabetic and nondiabetic group depicted a significant reduction in the periapical score after endodontic treatment at the 12-month follow-up (P < .05). Significantly less periapical healing was observed in the diabetic group (43%) compared with the nondiabetic group (80%) at the 12-month follow-up (P < .05). HbA1c levels in the diabetic group increased at each follow-up after endodontic treatment. CONCLUSIONS Diabetes mellitus may have a negative impact on the outcome of endodontic treatment in terms of periapical healing. Nonsurgical endodontic treatment did not improve HbA1c levels in patients with type 2 diabetes.
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Affiliation(s)
- Suman Arya
- Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak, India
| | - Jigyasa Duhan
- Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak, India.
| | - Sanjay Tewari
- Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak, India
| | - Pankaj Sangwan
- Department of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak, India
| | - Veena Ghalaut
- Department of Biochemistry, Post Graduate Institute of Medical Sciences, Rohtak, India
| | - Sameer Aggarwal
- Department of Medicine/Endocrinology, Post Graduate Institute of Medical Sciences, Rohtak, India
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Mohd Sharif NA, Goh SL, Usman J, Wan Safwani WKZ. Biomechanical and functional efficacy of knee sleeves: A literature review. Phys Ther Sport 2017; 28:44-52. [PMID: 28673759 DOI: 10.1016/j.ptsp.2017.05.001] [Citation(s) in RCA: 9] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/22/2016] [Revised: 04/26/2017] [Accepted: 05/06/2017] [Indexed: 12/18/2022]
Abstract
BACKGROUND Knee sleeves are widely used for the symptomatic relief and subjective improvements of knee problems. To date, however, their biomechanical effects have not been well understood. OBJECTIVE To determine whether knee sleeves can significantly improve the biomechanical variables for knee problems. METHOD Systematic literature search was conducted on four online databases - PubMed, Web of Science, ScienceDirect and Springer Link - to find peer-reviewed and relevant scientific papers on knee sleeves published from January 2005 to January 2015. Study quality was assessed using the Structured Effectiveness Quality Evaluation Scale (SEQES). RESULTS Twenty studies on knee sleeves usage identified from the search were included in the review because of their heterogeneous scope of coverage. Twelve studies found significant improvement in gait parameters (3) and functional parameters (9), while eight studies did not find any significant effects of knee sleeves usage. CONCLUSION Most improvements were observed in: proprioception for healthy knees, gait and balance for osteoarthritic knees, and functional improvement of injured knees. This review suggests that knee sleeves can effect functional improvements to knee problems. However, further work is needed to confirm this hypothesis, due to the lack of homogeneity and rigor of existing studies.
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Affiliation(s)
- Nahdatul Aishah Mohd Sharif
- Department of Biomedical Engineering, Faculty of Engineering, University of Malaya, 50603, Kuala Lumpur, Malaysia
| | - Siew-Li Goh
- Sports Medicine Unit, Faculty of Medicine, University of Malaya, 50603, Kuala Lumpur, Malaysia
| | - Juliana Usman
- Department of Biomedical Engineering, Faculty of Engineering, University of Malaya, 50603, Kuala Lumpur, Malaysia; Centre for Applied Biomechanics, Faculty of Engineering, University of Malaya, 50603, Kuala Lumpur, Malaysia.
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Kurzweil PR. Editorial Commentary: Should I Order Prophylactic Antibiotics for My Next Knee Scope? Arthroscopy 2017; 33:163-164. [PMID: 28003070 DOI: 10.1016/j.arthro.2016.10.012] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/18/2016] [Accepted: 10/18/2016] [Indexed: 02/02/2023]
Abstract
Postoperative infections are going to happen. The question of whether prophylactic antibiotics can lower the infection rate in routine knee arthroscopy is investigated. Although a large number of cases were included in the study, the results did not reach statistical significance. Nevertheless, a significant trend toward a lower incidence of deep infection was seen when antibiotics were given.
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Abstract
Determining the appropriate sample size for a study, whatever be its type, is a fundamental aspect of biomedical research. An adequate sample ensures that the study will yield reliable information, regardless of whether the data ultimately suggests a clinically important difference between the interventions or elements being studied. The probability of Type 1 and Type 2 errors, the expected variance in the sample and the effect size are the essential determinants of sample size in interventional studies. Any method for deriving a conclusion from experimental data carries with it some risk of drawing a false conclusion. Two types of false conclusion may occur, called Type 1 and Type 2 errors, whose probabilities are denoted by the symbols σ and β. A Type 1 error occurs when one concludes that a difference exists between the groups being compared when, in reality, it does not. This is akin to a false positive result. A Type 2 error occurs when one concludes that difference does not exist when, in reality, a difference does exist, and it is equal to or larger than the effect size defined by the alternative to the null hypothesis. This may be viewed as a false negative result. When considering the risk of Type 2 error, it is more intuitive to think in terms of power of the study or (1 - β). Power denotes the probability of detecting a difference when a difference does exist between the groups being compared. Smaller α or larger power will increase sample size. Conventional acceptable values for power and α are 80% or above and 5% or below, respectively, when calculating sample size. Increasing variance in the sample tends to increase the sample size required to achieve a given power level. The effect size is the smallest clinically important difference that is sought to be detected and, rather than statistical convention, is a matter of past experience and clinical judgment. Larger samples are required if smaller differences are to be detected. Although the principles are long known, historically, sample size determination has been difficult, because of relatively complex mathematical considerations and numerous different formulas. However, of late, there has been remarkable improvement in the availability, capability, and user-friendliness of power and sample size determination software. Many can execute routines for determination of sample size and power for a wide variety of research designs and statistical tests. With the drudgery of mathematical calculation gone, researchers must now concentrate on determining appropriate sample size and achieving these targets, so that study conclusions can be accepted as meaningful.
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Affiliation(s)
- Avijit Hazra
- Department of Pharmacology, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, India
| | - Nithya Gogtay
- Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Mumbai, Maharashtra, India
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Bajwa SJS. Basics, common errors and essentials of statistical tools and techniques in anesthesiology research. J Anaesthesiol Clin Pharmacol 2015; 31:547-53. [PMID: 26702217 PMCID: PMC4676249 DOI: 10.4103/0970-9185.169087] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/26/2022] Open
Abstract
The statistical portion is a vital component of any research study. The research methodology and the application of statistical tools and techniques have evolved over the years and have significantly helped the research activities throughout the globe. The results and inferences are not accurately possible without proper validation with various statistical tools and tests. The evidencebased anesthesia research and practice has to incorporate statistical tools in the methodology right from the planning stage of the study itself. Though the medical fraternity is well acquainted with the significance of statistics in research, there is a lack of in-depth knowledge about the various statistical concepts and principles among majority of the researchers. The clinical impact and consequences can be serious as the incorrect analysis, conclusions, and false results may construct an artificial platform on which future research activities are replicated. The present tutorial is an attempt to make anesthesiologists aware of the various aspects of statistical methods used in evidence-based research and also to highlight the common areas where maximum number of statistical errors are committed so as to adopt better statistical practices.
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Affiliation(s)
- Sukhminder Jit Singh Bajwa
- Department of Anaesthesiology and Intensive Care, Gian Sagar Medical College and Hospital, Banur, Patiala, Punjab, India
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Raheja J, Tewari S, Tewari S, Duhan J. Evaluation of efficacy of chlorhexidine intracanal medicament on the periodontal healing of concomitant endodontic-periodontal lesions without communication: an interventional study. J Periodontol 2014; 85:1019-26. [PMID: 24835418 DOI: 10.1902/jop.2014.130430] [Citation(s) in RCA: 11] [Impact Index Per Article: 1.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/13/2022]
Abstract
BACKGROUND Treatment of concomitant endodontic-periodontal lesions remains a challenge in clinical practice and requires effective endodontic and regenerative periodontal therapy. Among other factors, cross seeding and recolonization of flora may affect the outcome of periodontal therapy. Intracanal medicaments have been shown to exert antimicrobial activity on the external root surface, and local delivery of antimicrobials has been suggested to be a complementary approach in the management of periodontitis. Therefore, the objective of this study is to determine the influence of chlorhexidine (CHX) intracanal medicament on the clinical outcomes of therapy. METHODS Thirty-one patients were divided into two treatment groups: 1) open flap debridement (OFD) in endodontically treated teeth (control); and 2) OFD in endodontically treated teeth with CHX placed in the coronal space (test). The clinical variables evaluated were probing depth (PD), clinical attachment level (CAL), and percentage of sites with PD ≥5 mm. Reevaluation was performed at 3 and 6 months post-surgery. RESULTS Both treatments resulted in improvement in all the clinical variables evaluated. Postoperative measurements from test and control groups showed reductions in mean PD of 2.22 ± 1.27 and 0.91 ± 0.81 mm, mean CAL gains of 2.16 ± 1.12 and 0.60 ± 0.93 mm, and 43.33% ± 31.37% and 17.71% ± 14.23% reduction in sites with PD ≥5 mm. Significantly more PD reduction, CAL gain, and percentage reduction in sites with PD ≥5 mm were observed in the test group at 6 months (P <0.05). CONCLUSION CHX may be used as an effective intracanal medicament for promoting periodontal healing in concomitant endodontic-periodontal lesions.
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Affiliation(s)
- Jyoti Raheja
- Department of Conservative Dentistry & Endodontics, Post Graduate Institute of Dental Sciences, Rohtak, Haryana, India
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Mundi R, Chaudhry H, Mundi S, Godin K, Bhandari M. Design and execution of clinical trials in orthopaedic surgery. Bone Joint Res 2014; 3:161-8. [PMID: 24869465 PMCID: PMC4097861 DOI: 10.1302/2046-3758.35.2000280] [Citation(s) in RCA: 25] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/09/2014] [Accepted: 02/04/2014] [Indexed: 01/13/2023] Open
Abstract
High-quality randomised controlled trials (RCTs) evaluating surgical therapies are fundamental to the delivery of evidence-based orthopaedics. Orthopaedic clinical trials have unique challenges; however, when these challenges are overcome, evidence from trials can be definitive in its impact on surgical practice. In this review, we highlight several issues that pose potential challenges to orthopaedic investigators aiming to perform surgical randomised controlled trials. We begin with a discussion on trial design issues, including the ethics of sham surgery, the importance of sample size, the need for patient-important outcomes, and overcoming expertise bias. We then explore features surrounding the execution of surgical randomised trials, including ethics review boards, the importance of organisational frameworks, and obtaining adequate funding. Cite this article: Bone Joint Res 2014;3:161-8.
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Affiliation(s)
- R. Mundi
- McMaster University, 293 Wellington Street North, Suite 110, Hamilton,
ON L8L 8E7, Canada
| | - H. Chaudhry
- McMaster University, 293 Wellington Street North, Suite 110, Hamilton,
ON L8L 8E7, Canada
| | - S. Mundi
- McMaster University, 293 Wellington Street North, Suite 110, Hamilton,
ON L8L 8E7, Canada
| | - K. Godin
- McMaster University, 293 Wellington Street North, Suite 110, Hamilton,
ON L8L 8E7, Canada
| | - M. Bhandari
- McMaster University, 293 Wellington Street North, Suite 110, Hamilton,
ON L8L 8E7, Canada
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Giuffrida MA. Type II error and statistical power in reports of small animal clinical trials. J Am Vet Med Assoc 2014; 244:1075-80. [DOI: 10.2460/javma.244.9.1075] [Citation(s) in RCA: 33] [Impact Index Per Article: 3.0] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/20/2022]
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Dahi-Taleghani M, Fazli B, Ghasemi M, Vosoughian M, Dabbagh A. Effect of intravenous patient controlled ketamine analgesiaon postoperative pain in opium abusers. Anesth Pain Med 2014; 4:e14129. [PMID: 24701419 PMCID: PMC3961031 DOI: 10.5812/aapm.14129] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 08/10/2013] [Revised: 11/22/2013] [Accepted: 12/01/2013] [Indexed: 12/29/2022] Open
Abstract
Background: Acutepostoperative pain is among the worst experience that patient scan undergo, and many analgesics have been used to suppress it; especially in chronic opium abusers. Ketamine is an N-methyl-D-aspartate antagonist analgesic, having both anesthetic and analgesic properties, which are not affected to the same extent in chronic opium abusers. Objectives: In this study, we assessed the analgesic effects of ketamine added to morphine as a patient-controlled analgesia method for acute pain management, compared with a placebo, inchronic maleopium abusers. Patients and Methods: After institutional review board approval for ethical considerations, a randomized double-blinded placebo controlled clinical trial was conducted. A total of 140 male patients aged 18-65 years, undergoing orthopedic surgery, were entered into the study after matching inclusion and exclusion criteria. All patients received the same anesthesia method; while the first group received ketamine (1mg/mL) and morphine (0.5 mg/mL) as a patient-controlled analgesia (70 patients), the second group received morphine (0.5 mg/mL) plus normal saline (70 patients). P value less than 0.05 was considered statistically significant. Results: The ketamine and morphine group of patients experienced less postoperative pain and required less postoperative rescue analgesia. However, the unwanted postoperative side effects were nearly the same; although increased levels of postoperative nausea and vomiting were observed in the ketamine and morphine group Conclusions: This study demonstrated improved analgesic effects after using intravenous patient controlled analgesia with ketamine on postoperative pain in opium abusers.
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Affiliation(s)
- Mastane Dahi-Taleghani
- Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Benjamin Fazli
- Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Mahshid Ghasemi
- Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Maryam Vosoughian
- Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
| | - Ali Dabbagh
- Anesthesiology Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran
- Corresponding author: Ali Dabbagh, Anesthesiology Research Center, ShahidBeheshti University of Medical Sciences, Tehran, Iran. Tel: +98-989121972368, Fax: +98-982122432572, E-mail: ,
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Mazlyn MM, Nagarajah LHL, Fatimah A, Norimah AK, Goh KL. Effects of a probiotic fermented milk on functional constipation: a randomized, double-blind, placebo-controlled study. J Gastroenterol Hepatol 2013; 28:1141-7. [PMID: 23432408 DOI: 10.1111/jgh.12168] [Citation(s) in RCA: 54] [Impact Index Per Article: 4.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Accepted: 02/04/2013] [Indexed: 12/20/2022]
Abstract
BACKGROUND AND AIM Evidence suggests that probiotics reduce certain constipation-related symptoms. Lactobacillus casei strain Shirota has never been tested as treatment for functional constipation in otherwise-healthy subjects. To evaluate the efficacy of this probiotic among adults with functional constipation was aimed. METHODS Subjects with functional constipation (Rome II-defined) were randomized to intake L. casei strain Shirota fermented milk or placebo once daily for 4 weeks under double-blind condition. Primary outcomes were constipation severity and stool frequency; secondary outcomes were stool consistency and quantity. RESULTS In intent-to-treat population, compared with baseline, constipation severity and stool frequency improved in both probiotic (n = 47) and control groups (n = 43), but improvements were comparable in both groups at week 4 (α = 5% level). In probiotic group, stool consistency and quantity at week 4 improved significantly versus baseline but not versus control. Considering that the study agent is non-pharmaceutical and the purpose of supplementation is for long-term effect, re-evaluation at α = 10% was conducted, which showed significant improvement in constipation severity at week 4 (P = 0.058). Magnitude of the probiotic effect on stool consistency was small but grew over time, d = 0.19, 95% confidence interval 0.00-0.35 (Week 4), d = 0.29, 95% confidence interval 0.11-0.52 (postintervention). Post-hoc exploratory analysis suggests incomplete evacuation may decrease with probiotic intake. CONCLUSIONS Four-week administration of L. casei strain Shirota did not alleviate constipation severity or stool frequency, consistency, and quantity when compared with control. With re-evaluation at α = 10% level, improvement in constipation severity was significant at week 4. To obtain conclusive results, further studies with longer intervention are warranted.
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Affiliation(s)
- Mena Mustapha Mazlyn
- Department of Nutrition and Dietetics, School of Pharmacy and Health Sciences, International Medical University, Kuala Lumpur, Malaysia
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Ahmed Ali U, Issa Y, Bruno MJ, van Goor H, van Santvoort H, Busch ORC, Dejong CHC, Nieuwenhuijs VB, van Eijck CH, van Dullemen HM, Fockens P, Siersema PD, Gouma DJ, van Hooft JE, Keulemans Y, Poley JW, Timmer R, Besselink MG, Vleggaar FP, Wilder-Smith OH, Gooszen HG, Dijkgraaf MGW, Boermeester MA. Early surgery versus optimal current step-up practice for chronic pancreatitis (ESCAPE): design and rationale of a randomized trial. BMC Gastroenterol 2013; 13:49. [PMID: 23506415 PMCID: PMC3610165 DOI: 10.1186/1471-230x-13-49] [Citation(s) in RCA: 60] [Impact Index Per Article: 5.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 02/18/2013] [Accepted: 03/07/2013] [Indexed: 12/11/2022] Open
Abstract
Background In current practice, patients with chronic pancreatitis undergo surgical intervention in a late stage of the disease, when conservative treatment and endoscopic interventions have failed. Recent evidence suggests that surgical intervention early on in the disease benefits patients in terms of better pain control and preservation of pancreatic function. Therefore, we designed a randomized controlled trial to evaluate the benefits, risks and costs of early surgical intervention compared to the current stepwise practice for chronic pancreatitis. Methods/design The ESCAPE trial is a randomized controlled, parallel, superiority multicenter trial. Patients with chronic pancreatitis, a dilated pancreatic duct (≥ 5 mm) and moderate pain and/or frequent flare-ups will be registered and followed monthly as potential candidates for the trial. When a registered patient meets the randomization criteria (i.e. need for opioid analgesics) the patient will be randomized to either early surgical intervention (group A) or optimal current step-up practice (group B). An expert panel of chronic pancreatitis specialists will oversee the assessment of eligibility and ensure that allocation to either treatment arm is possible. Patients in group A will undergo pancreaticojejunostomy or a Frey-procedure in case of an enlarged pancreatic head (≥ 4 cm). Patients in group B will undergo a step-up practice of optimal medical treatment, if needed followed by endoscopic interventions, and if needed followed by surgery, according to predefined criteria. Primary outcome is pain assessed with the Izbicki pain score during a follow-up of 18 months. Secondary outcomes include complications, mortality, total direct and indirect costs, quality of life, pancreatic insufficiency, alternative pain scales, length of hospital admission, number of interventions and pancreatitis flare-ups. For the sample size calculation we defined a minimal clinically relevant difference in the primary endpoint as a difference of at least 15 points on the Izbicki pain score during follow-up. To detect this difference a total of 88 patients will be randomized (alpha 0.05, power 90%, drop-out 10%). Discussion The ESCAPE trial will investigate whether early surgery in chronic pancreatitis is beneficial in terms of pain relief, pancreatic function and quality of life, compared with current step-up practice. Trial registration ISRCTN: ISRCTN45877994
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Affiliation(s)
- Usama Ahmed Ali
- Department of Surgery, Academic Medical Center Amsterdam, PO 22660, 1100 DD, Amsterdam, the Netherlands
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Saini HR, Tewari S, Sangwan P, Duhan J, Gupta A. Effect of Different Apical Preparation Sizes on Outcome of Primary Endodontic Treatment: A Randomized Controlled Trial. J Endod 2012; 38:1309-15. [DOI: 10.1016/j.joen.2012.06.024] [Citation(s) in RCA: 84] [Impact Index Per Article: 6.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 03/31/2012] [Revised: 06/14/2012] [Accepted: 06/20/2012] [Indexed: 11/26/2022]
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Longo UG, Loppini M, Berton A, Marinozzi A, Maffulli N, Denaro V. The FIFA 11+ program is effective in preventing injuries in elite male basketball players: a cluster randomized controlled trial. Am J Sports Med 2012; 40:996-1005. [PMID: 22415208 DOI: 10.1177/0363546512438761] [Citation(s) in RCA: 149] [Impact Index Per Article: 11.5] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 01/31/2023]
Abstract
BACKGROUND Recently, structured training programs for sports injury prevention ("The 11" and "The 11+") have been validated in soccer. The FIFA 11+ program has not been evaluated in basketball. HYPOTHESIS The FIFA 11+ program is effective in reducing the rates of injury in male basketball players. STUDY DESIGN Randomized controlled trial; Level of evidence, 1. METHODS The authors randomized 11 teams of the same club. Seven teams were allocated to the intervention group (80 players; mean [SD] age 13.5 [2.3] years), and 4 teams were allocated to the control group (41 players; mean [SD] age 15.2 [4.6] years). The authors conducted an injury surveillance program during a 9-month season. The primary outcome was any injury to the athletes. The secondary outcome was any injury to the lower extremity (foot, ankle, lower leg, knee, thigh, groin, and hip). They included an analysis of the type of exposure (match or training), injury location in the body, and type of injury (acute or overuse). RESULTS During the 9-month season, 23 (19%) of the 121 players included in the study sustained a total of 31 injuries (14 in the intervention group and 17 in the control group). In the intervention group, injury rates per 1000 athlete-exposures were lower than those in the control group, with statistical significance, for overall injuries (0.95 vs 2.16; P = .0004), training injuries (0.14 vs 0.76; P = .007), lower extremity injuries (0.68 vs 1.4; P = .022), acute injuries (0.61 vs 1.91; P < .0001), and severe injuries (0 vs 0.51; P = .004). The intervention group also had statistically significant lower injury rates for trunk (0.07 vs 0.51; P = .013), leg (0 vs 0.38; P = .007), and hip and groin (0 vs 0.25; P = .023) compared with the control group. There was no statistically significant difference in match injuries, knee injuries, ankle injuries, and overuse injuries between 2 groups. The most frequent acute injury diagnoses were ligament sprains (0.41 and 0.38 in the intervention and control groups, respectively; P < .006) and contractures (0.76 and 0.07 in the control and intervention groups, respectively; P < .003). CONCLUSION The FIFA 11+ warm-up program is effective in reducing the rates of injuries in elite male basketball players.
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Affiliation(s)
- Umile Giuseppe Longo
- Department of Trauma and Orthopaedic Surgery, UniversityCampus Bio-Medico of Rome, Italy
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Abstract
In most areas in life, it is difficult to work with populations and hence researchers work with samples. The calculation of the sample size needed depends on the data type and distribution. Elements include consideration of the alpha error, beta error, clinically meaningful difference, and the variability or standard deviation. The final number arrived at should be increased to include a safety margin and the dropout rate. Over and above this, sample size calculations must take into account all available data, funding, support facilities, and ethics of subjecting patients to research.
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Affiliation(s)
- Nithya J Gogtay
- Department of Clinical Pharmacology, Seth GS Medical College and KEM Hospital, Parel, Mumbai, Maharashtra, India.
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Grasso A, Milano G, Salvatore M, Falcone G, Deriu L, Fabbriciani C. Single-row versus double-row arthroscopic rotator cuff repair: a prospective randomized clinical study. Arthroscopy 2009; 25:4-12. [PMID: 19111212 DOI: 10.1016/j.arthro.2008.09.018] [Citation(s) in RCA: 166] [Impact Index Per Article: 10.4] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/18/2008] [Revised: 08/29/2008] [Accepted: 09/18/2008] [Indexed: 02/08/2023]
Abstract
PURPOSE The purpose of this study was to compare the clinical outcome of arthroscopic rotator cuff repair with single-row and double-row techniques. METHODS Eighty patients with a full-thickness rotator cuff tear underwent arthroscopic repair with suture anchors. They were divided into 2 groups of 40 patients according to repair technique: single row (group 1) or double row (group 2). Results were evaluated by use of the Disabilities of the Arm, Shoulder and Hand (DASH) and Work-DASH self-administered questionnaires, normalized Constant score, and muscle strength measurement. On analyzing the results at a 2-year follow-up, we considered the following independent variables: baseline scores; age; gender; dominance; location, shape, and area of cuff tear; tendon retraction; fatty degeneration; treatment of biceps tendon; and rotator cuff repair technique (anchors or anchors and side to side). Univariate and multivariate statistical analyses were performed to determine which variables were independently associated with the outcome. Significance was set at P < .05. RESULTS Of the patients, 8 (10%) were lost to follow-up. Comparison between groups did not show significant differences for each variable considered. Overall, according to the results, the mean DASH scores were 15.4 +/- 15.6 points in group 1 and 12.7 +/- 10.1 points in group 2; the mean Work-DASH scores were 16.0 +/- 22.0 points and 9.6 +/- 13.3 points, respectively; and the mean Constant scores were 100.5 +/- 17.8 points and 104.9 +/- 21.8 points, respectively. Muscle strength was 12.7 +/- 5.7 lb in group 1 and 12.9 +/- 7.0 lb in group 2. Univariate and multivariate analysis showed that only age, gender, and baseline strength significantly and independently influenced the outcome. Differences between groups 1 and 2 were not significant. CONCLUSIONS At short-term follow-up, arthroscopic rotator cuff repair with the double-row technique showed no significant difference in clinical outcome compared with single-row repair. LEVEL OF EVIDENCE Level I, high-quality randomized controlled trial with no statistically significant differences but narrow confidence intervals.
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Kim YS, Lee JY, Yang SC, Song JH, Koh HS, Park WK. Comparative study of the influence of room-temperature and warmed fluid irrigation on body temperature in arthroscopic shoulder surgery. Arthroscopy 2009; 25:24-9. [PMID: 19111215 DOI: 10.1016/j.arthro.2008.08.005] [Citation(s) in RCA: 35] [Impact Index Per Article: 2.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/23/2008] [Revised: 06/29/2008] [Accepted: 08/16/2008] [Indexed: 02/02/2023]
Abstract
PURPOSE The purpose of this study was to evaluate the effect of irrigation fluid temperature on body temperature and other variables, and to determine their correlations. METHODS A prospective randomized study was performed of 50 patients undergoing arthroscopic shoulder surgery who received irrigation fluid either with room temperature or warmed to 37 degrees C to 39 degrees C. Core body temperature was checked at regular intervals, and additional variables, such as length of anesthesia and surgery, amount of irrigation fluid and intravenous fluid used, amount of bleeding, weight gain, and postoperative pain were collected during surgery and postoperatively. RESULTS The final core body temperature was 35.5 +/- 0.3 degrees C in the room-temperature fluid group and 36.2 +/- 0.3 degrees C in the warmed fluid group (P < .001). The temperature drop was 0.86 +/- 0.2 degrees C in the room-temperature fluid group and 0.28 +/- 0.2 degrees C in the warmed fluid group (P < .001). Hypothermia occurred in 91.3% of patients in the room-temperature fluid group; the incidence of hypothermia was much lower in the warmed fluid group (17.4%; P < .001). Of the variables measured, the patient's age and amount of irrigation fluid used correlated with core body temperature in the room-temperature fluid group. No variables correlated with core body temperature in the warmed fluid group. CONCLUSIONS Hypothermia occurred more often in shoulder arthroscopic surgery with room-temperature fluid irrigation than with warmed fluid irrigation. The patient's age and amount of irrigation fluid used correlate with core body temperature when using room-temperature irrigation fluid. The use of warm irrigation fluid during arthroscopic shoulder surgery decreases perioperative hypothermia, especially in elderly patients. LEVEL OF EVIDENCE Level I, therapeutic randomized controlled trial.
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Affiliation(s)
- Yong-Shin Kim
- Department of Anesthesiology, College of Medicine, the Catholic University of Korea, Seoul, Korea
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Longo UG, King JB, Denaro V, Maffulli N. Double-bundle arthroscopic reconstruction of the anterior cruciate ligament. ACTA ACUST UNITED AC 2008; 90:995-9. [DOI: 10.1302/0301-620x.90b8.20083] [Citation(s) in RCA: 47] [Impact Index Per Article: 2.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 01/29/2023]
Abstract
There is a trend towards the use of double-bundle techniques for the reconstruction of the anterior cruciate ligament. This has not been substantiated scientifically. The functional outcome of these techniques is equivalent to that of single-bundle methods. The main advantage of a double-bundle rather than a single-bundle reconstruction should be a better rotational stability, but the validity and accuracy of systems for the measurement of rotational stability have not been confirmed. Despite the enthusiasm of surgeons for the double-bundle technique, reconstruction with a single-bundle should remain the standard method for managing deficiency of the anterior cruciate ligament until strong evidence in favour of the use of the double-bundle method is available.
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Affiliation(s)
- U. G. Longo
- Department of Orthopaedic and Trauma Surgery, Campus Biomedico University, Via Alvaro del Portillo 200, 00128 Trigoria, Rome, Italy
| | - J. B. King
- London Independent Hospital, Stepney Green, London E1 4NL, UK
| | - V. Denaro
- Department of Orthopaedic and Trauma Surgery, Campus Biomedico University, Via Alvaro del Portillo 200, 00128 Trigoria, Rome, Italy
| | - N. Maffulli
- Department of Orthopaedic and Trauma Surgery, University Hospital of North Staffordshire, Keele University School of Medicine, Stoke on Trent ST4 7LN, UK
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