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"This book will examine current issues and controversies in the design of clinical trials, including topics in adaptive and sequential designs, the design of correlative genomic studies, the design of studies in which missing data is anticipated. Each chapter will be written by an expert conducting research in the topic of that chapter. As a collection, the chapters would be intended to serve as a guidance for statisticians designing trials."

"In the past few years the authors of this 5th edition, as teachers and research supervisors in academic and top-clinical facilities, have been able to closely observe the latest developments in the field of clinical data analysis, and they have been able to assess their performance. The novel methods are explained using practical examples and step-by-step analyses readily accessible for non-mathematicians. All of the novel chapters have been internationally published by the authors in peer-reviewed journal, including the American Journal of Therapeutics, the European Journal of Clinical Investigation, The International journal of Clinical Pharmacology and therapeutics, and other journals, and permission is granted by all of them to use this material in the current book. They firmly believe that any reader can benefit from this clinical approach to statistical data analysis."

"Summary:Critical appraisal is now accepted as central to the development of rational health care and evidence-based medicine, by applying it to questions of aetiology, clinical therapy, and health care management. The reader will learn how to assess the strengths and weaknesses of new studies, and how to conduct their own studies"

"Pendahuluan: Enhanced Recovery After Surgery (ERAS) bertujuan untuk menstandardisasi manajemen perioperatif dan meningkatkan luaran klinis. Implementasi ERAS pada total knee replacement (TKR) mengurangi mortalitas, transfusi, komplikasi, dan length of stay (LOS) tanpa mempengaruhi readmisi. Studi ini bertujuan mengevaluasi ERAS pada pasien TKR unilateral di Indonesia.Metode: Penelitian ini menggunakan desain klinis acak tersamar tunggal di RSUPN Dr. Cipto Mangunkusumo dan RS Fatmawati, Jakarta, dengan 55 pasien TKR unilateral berusia 60-70 tahun dengan OA grade III-IV sebagai subjek. Metode analisis data melibatkan SPSS dengan uji normalitas, Chi-square, T tidak berpasangan, dan Mann Whitney untuk menilai efektivitas ERAS dibandingkan dengan protokol konvensional.Hasil: Hasil menunjukkan bahwa protokol ERAS meningkatkan skor Knee Special Score (KSS) (p=0,001, mean difference=4,09) dan Oxford Knee Score (OKS) (p<0,001, mean difference=4,98), serta mengurangi durasi rawat inap (p<0,001, mean difference=-2,15 hari) dan nyeri pascaoperasi (p<0,001, mean difference=-2,01) dibandingkan protokol konvensional. Faktor pre-operatif dan post-operatif seperti usia, komorbiditas, dan mobilisasi dini memberikan pengaruh terhadap durasi lama rawat inap. ERAS efektif menurunkan nyeri pascaoperasi dan meningkatkan skor KSS serta OKS. Integrasi edukasi praoperatif, manajemen nyeri, mobilisasi dini, dan perawatan perioperatif komprehensif meningkatkan hasil fungsional.Kesimpulan: Program ERAS secara signifikan memperbaiki skor KSS, OKS, mengurangi durasi rawat inap, dan menurunkan nyeri pascaoperasi pada pasien TKR unilateral dibandingkan protokol konvensional.

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Introduction: Enhanced Recovery After Surgery (ERAS) aims to standardize perioperative management and improve clinical outcomes. ERAS implementation in total knee replacement (TKR) reduces mortality, transfusions, complications, and length of stay (LOS) without affecting readmissions. This study aims to evaluate ERAS in unilateral TKR patients in Indonesia.

Methods: This study utilized a single-blind randomized clinical trial design at RSUPN Dr. Cipto Mangunkusumo and RS Fatmawati, Jakarta, involving 55 unilateral TKR patients aged 60-70 years with grade III-IV OA. Data analysis methods included SPSS, normality tests, Chi-square, independent T-tests, and Mann Whitney tests to evaluate the effectiveness of ERAS compared to conventional protocols.

Result: The results show that the ERAS protocol improves Knee Society Score (KSS) (p=0.001, mean difference=4.09) and Oxford Knee Score (OKS) (p<0.001, mean difference=4.98) scores, reduces length of stay (p<0.001, mean difference=-2.15 days), and decreases postoperative pain (p<0.001, mean difference=-2.01) compared to conventional protocols.

Discussion: Pre-operative and post-operative factors such as age, comorbidities, and early mobilization influence the length of stay. ERAS effectively reduces postoperative pain and improves KSS and OKS scores. Integrating preoperative education, pain management, early mobilization, and comprehensive perioperative care enhances functional outcomes.

Conclusion: The ERAS program significantly improves KSS, OKS scores, reduces length of stay, and decreases postoperative pain in unilateral TKR patients compared to conventional protocols."

"This is the fifth edition of a very successful textbook on clinical trials methodology, written by recognized leaders who have long and extensive experience in all areas of clinical trials. The three authors of the first four editions have been joined by two others who add great expertise. Most chapters have been revised considerably from the fourth edition. A chapter on regulatory issues has been included and the chapter on data monitoring has been split into two and expanded. Many contemporary clinical trial examples have been added. There is much new material on adverse events, adherence, issues in analysis, electronic data, data sharing, and international trials. This book is intended for the clinical researcher who is interested in designing a clinical trial and developing a protocol. It is also of value to researchers and practitioners who must critically evaluate the literature of published clinical trials and assess the merits of each trial and the implications for the care and treatment of patients. The authors use numerous examples of published clinical trials to illustrate the fundamentals.The text is organized sequentially from defining the question to trial closeout. One chapter is devoted to each of the critical areas to aid the clinical trial researcher. These areas include pre-specifying the scientific questions to be tested and appropriate outcome measures, determining the organizational structure, estimating an adequate sample size, specifying the randomization procedure, implementing the intervention and visit schedules for participant evaluation, establishing an interim data and safety monitoring plan, detailing the final analysis plan, and reporting the trial results according to the pre-specified objectives."