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"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."

"Bone mineral content at old age is dependent upon the peak bone mass achieved in youth and subsequent adult bone loss (Matkovic, 1992). Adequate calcium consumption during childhood is beneficial for the acquisition of peak bone mass and density. It is therefore, calcium has been considered to play important role in the pathogenesis of osteoporosis (NIH, 1994), and osteoporosis has been described as a pediatric disease that manifests itself in old age (Lysen and Walker, 1997). If children fail to take in enough calcium, they are more likely to develop osteoporosis later in life (Insel et al., 2002). Nevertheless, calcium is one of the nutrients that most likely to be low or deficient in children's diets (Krause's, 2000). Recently, calcium has been suspected to have a positive effect in preventing some disorders, including diarrhea. Bovee et al., (2003) indicated that low calcium intake has been shown to impair host resistance to food-borne intestinal infections. Because of childhood morbidity and mortality due to infectious diarrhea is very high in developing countries, adequate dietary calcium intakes of the children will likely improve their bone as well as intestinal health (Bovee et al., 2003). Dairy products are always regarded as primary source of calcium. It is difficult to meet the RDA for calcium without milk or milk products (Krause, 1992). Unfortunately, the general Indonesian population does not commonly consume milk.

The results of 1997 national survey on households' food consumption pattern across provinces in Indonesia reveal that milk consumption was zero, or milk product was never consumed in the last three months at the time of survey (Sumarno at al., 1997). In line with the 1997 national survey, Ariani et al., (1997) reported that the level of milk consumption was lower than that of other animal products across the provinces in Indonesia, and in general, milk consumption of Indonesian population was below the standard of adequacy of milk consumption according to Widyakarya National Pangan dan Gizi 1998 (4.6 kg/cap/year). The above facts indicate that many Indonesians may consume calcium-deficient diet."

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Latar belakang: Heterogenitas pasien endometriosis terkait presentasi fenotip klinisnya memerlukan standar pengambilan data. Saat ini belum ada standardisasi pengambilan data fenotip klinis pasien endometriosis di Indonesia. Translasi kuesioner klinis WERF-EPHect Clinical Questionnaire (Standard) (EPQ-S) ke dalam Bahasa Indonesia dan validasi kuesioner ini diperlukan untuk mengetahui apakah alat ini dapat digunakan di Indonesia sebagaimana telah digunakan di negara lain dan memastikan bahwa data yang dihasilkan akurat dan andal.

 

Tujuan: Untuk membuat sebuah standar pengambilan data fenotip klinis pasien endometriosis di Indonesia dan untuk mengetahui hasil terjemahan dan validitas kuesioner klinis WERF-EPHect Clinical Questionnaire (Standard) (EPQ-S) yang telah diterjemahkan ke dalam Bahasa Indonesia

 

Metode: Penelitian ini dilakukan dengan metode transkultural adaptasi. Uji validasi ini kuesioner EPHect EPQ-S dilakukan melalui proses forward-backward translation, harmonisasi oleh para expert, cognitive debriefing kepada target kuesoioner serta proofreading dan finalisasi oleh para expert. Penelitian dilakukan di RSCM selama 6 bulan yaitu Januari 2019 sampai Juli 2019.

 

Hasil: Translasi dan validasi isi kuesioner WERF-EPHect Clinical Questionnaire (Standard) Versi Indonesia memiliki 10 tahap termasuk proses persiapan, Forward Translation (translasi maju), proses rekonsiliasi, Backward Translation (translasi balik), review translasi balik, Proses Harmonisasi, proses Cognitive Debriefing, review hasil cognitive debriefing dan finalisasi, proses Proofreading dan laporan Final. Terdapat perbedaan budaya dari negara kuesioner asal termasuk obat-obatan yang tersedia di Indonesia, istilah-istilah medis yang lumrah di Negara asal namun asing di populasi Indonesia, dan penyajian suku ras yang tidak menggambarkan varian suku ras Indonesia.

 

Kesimpulan: Didapatkan kuesioner klinis WERF-EPHect Clinical Questionnaire (Standard) (EPQ-S) versi Bahasa Indonesia dengan isi sesuai kebutuhan pengguna di Indonesia dan dapat diaplikasikan di RSCM, dari 116 butir pertanyaan terdapat 21 butir pertanyaan dalam kuesioner yang harus terpimpin.

 

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Background: The heterogeneity of endometriosis patients related to the presentation of clinical phenotypes requires standard data collection. At present there is no standardization of clinical phenotype data for endometriosis patients in Indonesia. Translation of the WERF-EPHect Clinical Questionnaire (Standard) clinical questionnaire (EPQ-S) into Indonesian language and the validation of this questionnaire is needed to find out whether this tool can be used in Indonesia as it has been used in other countries and ensure that the resulting data is accurate and reliable.

 

Objective: To create a standard for taking clinical phenotype data for endometriosis patients in Indonesia and to find out the translation results and the validity of the WERF-EPHect Clinical Questionnaire (Standard) clinical questionnaire (EPQ-S) that has been translated into Indonesian and has been accurate and reliable.

 

Method: This research was conducted with the transcultural adaptation method. This validation test EPHect EPQ-S questionnaire was carried out through a process of forward-backward translation, harmonization by experts, cognitive debriefing to questionnaire targets and proofreading and finalization by experts. The study was conducted at the RSCM for 6 months, namely January 2019 to July 2019.

 

Results: Translation and validation of the contents of the Indonesian version of the WERF-EPHect Clinical Questionnaire (Standard) questionnaire have 10 stages including the preparation process, Forward Translation, forward reconciliation process, Backward Translation, back translational review, Harmonization Process, Cognitive Debriefing process, reviewing cognitive debriefing and finalization results, Proofreading process and Final report. There are cultural differences from the country of origin of the questionnaire including medicines available in Indonesia, medical terms that are common in the country of origin but unfamiliar in Indonesian population, and the presentation of racial tribes that do not describe variants of Indonesian racial tribes.

 

Conclusion: The WERF-EPHect Clinical Questionnaire (Standard) (EPQ-S) Indonesian version was obtained with contents according to the needs of users in Indonesia and can be applied at the RSCM, out of 116 questions there are 21 questions in the questionnaire that must be guided.

 

Keywords: Translation, Validation, WERF-EPHect Clinical Questionnaire (Standard), Clinical Phenotype, Endometriosis, Indonesia

 

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"The pace of therapeutic advances in the treatment of cardiovascular diseases is rapid, and new clinically–relevant information appears with such frequency that it can be extremely challenging for clinicians to keep up. Still, knowledge and interpretation of major clinical trials is crucial for the range of clinicians who manage cardiovascular patients, especially since important trial evidence often needs to be implemented soon after it is published. Confidently apply gold standard treatment for 10 of the most critical areas of cardiology Written by an international team of experts, Cardiovascular clinical trials : putting the evidence into practice, provides a succinct overview of recent major clinical trials, the gold standard for all medical treatment, across all the major cardiovascular subspecialties, to ensure you’re up–to–date on the most critical findings Guides cardiology trainees and clinicians on how cardiovascular clinical trials are designed and conducted, including statistical methodology."

"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."

"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"