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"ABSTRACTDalam ilmu kedokteran, demi tercapai keselamatan pasien maka tindakan medis harus sesuai dengan evidence based medicine (EBM) berdasarkan uji klinik. Namun, kerap kali tenaga medis menerapkan tindakan medis tanpa uji klinik. Penelitian ini bertujuan untuk membahas mengenai pengaturan dan penerapan uji klinik terhadap tindakan medis, serta pertanggungjawaban hukum tenaga medis yang melakukan tindakan medis tanpa uji klinik ditinjau dari hukum kesehatan Indonesia. Penelitian ini menggunankan metode penelitian yuridis-normatif, dimana menitikberatkan pada studi kepustakaan sebagai data utamanya serta wawacara dan studi dokumen yang berfungsi untuk melengkapi serta menunjang data kepustakaan. Hasil penelitian ini bersifat deskriptif analitis. Dalam hukum positif Indonesia, belum ada pengaturan mengenai penerapan uji klinik terhadap tindakan medis secara khusus. Adapun pedoman penerapan uji klinik terhadap tindakan medis ialah International Conference on Harmonization-Good Clinical Practice (ICH-GCP) yang tidak memiliki kekuatan hukum. Tenaga medis yang melakukan tindakan medis tanpa uji klinik, maka ia telah melakukan pelanggaran disiplin karena tidak bertindak sesuai standar profesi kedokteran, pengetahuan, pengalaman, dan  kualifikasinya. Sehingga, diperlukan pengaturan secara khusus mengenai uji klinik terhadap tindakan medis serta diperlukan perubahan atas sifat Majelis Kehormatan Disiplin Kedokteran Indonesia yang sebelumnya bersifat pasif menjadi aktif agar dapat mengusut penerapan tindakan medis tanpa uji klinik sebagai pelanggaran disiplin, meskipun tidak ada pengaduan sebelumnya.

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ABSTRACTIn medical science, in order to achieve patient safety, medical treatment must be in accordance with evidence based medicine (EBM) based on clinical trials. However, often medical personnel apply medical treatment without clinical trials. This study aims to discuss the regulation and application of clinical trials on medical treatment, as well as the legal responsibility of medical personnel who carry out medical treatment without clinical trials in terms of Indonesian health law. This study uses a juridical-normative research method, which focuses on the study of literature as the main data as well as interviews and document studies that serve to supplement and support library data. The results of this study are descriptive analytical. In Indonesian positive law, there are no regulations regarding the application of clinical trials to medical treatment specifically. The guidelines for the implementation of clinical trials on medical measures are the International Conference on Harmonization-Good Clinical Practice (ICH-GCP) which has no legal force. Medical personnel who carry out medical actions without clinical trials, they have committed disciplinary violations because they do not act according to medical professional standards, knowledge, experience, and qualifications. Thus, special regulation are needed regarding clinical trials of medical treatments and changes the trait of the Indonesian Medical Disciplinary Board (MKDKI) are needed from passive to active, in order to be able to investigate the application of medical treatment without clinical trials as disciplinary violations, even though there were no previous complaints."

"Pasien anak memiliki risiko untuk mengalami penurunan kondisi klinis secara tiba-tiba hingga berakhir pada kematian. Perburukan klinis dapat dideteksi beberapa jam sebelum terjadinya kondisi serius yang mengancam jiwa sehingga dibutuhan suatu startegi untuk mendeteksi kegawatdaruratan penerapan sistem peringatan dini. Sejak tahun 2014, Rumah Sakit Cipto Mangunkusumo (RSCM) Jakarta menerapkan system skor nursing early warning scoring system(NEWSS) yang disusun berdasarkan modifikasi dari sistem skor serupa pada orang dewasa. Namun beberapa penelitian telah mengembangkan dan memvalidasi suatu sistem skor dengan tujuan yang sama yang digunakan sepsifik untuk pasien bayi dan anak, yakni pediatric early warning score(PEWS). Penelitian ini bertujuan untuk membandingkan PEWS dan NEWSS dalam mengidentifikasi deteriorasi klnis pasien anak yang dirawat di rumah sakit. Penelitian ini dilakukan pada 81 anak yang datang ke instalasi gawat darurat (IGD), diukur skor PEWS dan NEWSS secara bersamaan, kemudian diamati selama 6 jam atau sampai terjadinya deteriorasi klinis. Sebanyak 51 anak mengalami deteriorasi klinis berupa rawat PICU (31 anak), intubasi (14 anak), resusitasi jantung paru (2), dan meninggal (4 anak).Kedua sistem skor, baik NEWSS dan PEWS dapat menilai dan memprediksi kejadian deteriorasi klinis pada anak (NEWSS AUC 0,77; 95% CI 0,68-0,88; p < 0,001 dan PEWS AUC 0,87; 95% CI 0,80-0,95; p < 0,001), serta memiliki spesifisitas yang sama baiknya pada nilai cutt-off5 (0,93; 95% CI 0,77-0,99 vs 0,96; 95% CI 0,82-0,99). Namun, skor PEWS memiliki sensitivitas yang lebih tinggi (0,80; 95% CI 0,66-0,90) dibandingkan dengan NEWSS (0,58; 95% CI 0,44-0,72). Oleh karena itu, sistem skor PEWS lebih baik dibandingkan NEWSS dalam mengidentifikasi deteriorasi klinis pasien anak yang di rawat di rumah sakit.

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Pediatric patients have a risk of experiencing a sudden decrease in clinical condition until death. Clinical deterioration can be detected several hours before the occurrence of serious life-threatening conditions so that a strategy is needed to detect the emergence of an early warning system. Since 2014, Cipto Mangunkusumo Hospital Jakarta has implemented a nursing early warning scoring system (NEWSS) that was compiled based on a modification of a similar scoring system for adults. However, several studies have developed and validated a score system with the same purpose that is used specifically for infant and pediatric patients, namely pediatric early warning score (PEWS). This study aims to compare PEWS and NEWSS in identifying the clinical deterioration of pediatric patients who are hospitalized. The study was conducted on 81 children who came to the emergency department, measured PEWS and NEWSS scores simultaneously, then observed for 6 hours or until clinical deterioration occurred. A total of 51 children underwent clinical deterioration such as tranfser to pediatric intensive care (31 children), intubation (14 children), cardiac pulmonary resuscitation (2), and death (4 children). Both score systems, NEWSS and PEWS, can assess and predict the incidence of clinical deterioration in children (NEWSS AUC 0.77; 95% CI 0.68-0.88; p <0.001 and PEWS AUC 0.87; 95% CI 0, 80-0.95; p <0.001), and have the same good specificity at a cut-off value of 5 (0.93; 95% CI 0.77-0.99 vs. 0.96; 95% CI 0.82- 0.99). However, the PEWS score has a higher sensitivity (0.80; 95% CI 0.66-0.90) compared to NEWSS (0.58; 95% CI 0.44-0.72). Therefore, the PEWS score system is better than NEWSS in identifying clinical deterioration of pediatric patients treated in hospitals."

"Dewasa ini keberhasilan rumah saldt diukur dalam memberikan pelayanan yang bermutu. Mum pelayanan pada alchimya dihubungkan dengan kepuasan kepada pasien_ Kepuasan pasien dilihat dari harapan dan kebutuhan terhadap pelayanan yang mereka terima. Penulisan tesis ini bertujuan untuk mendapakan informasi tentang mutu pelayanan, dengan indikator kepuasan pasien dalam hubungannya dengan aspek pelayanan dokter, pelayanan perawat, administrasi keuangan dan kenyamanan. selain itu ditinjau pengaruh karakteristik pasien yaitu usia, jenis kelamin, pendidikan, pekeijaan, pengetahuan, ternpat tinggal (iarak tempuh), penghasilan, pengalaman di RS lain dan penanggung biaya. Adanya berbagai keluhan maupun kritikan terhadap pelayanan yang mendasari penelitian ini, Penclitian ini bcrsifat deskriptifanalitik kuantitatif cross sectional. Data primer didapat dari melalui kuosioner kepada 206 responden melalui wawancara, selama 25 hari kerja pada minggu ke 2 bulan mei sampai minggu kc 2 bulan juni 2008. Dari hasil penelitian didapat responden yang menyatakan puas terhadap selumh aspek pelayanan yang diteliti sebanyak 59.7% Dari aspck pelayanan dan karakteristik pasien temyata aspek kebersihan - kenyamanan, jarak tempuh, penghasilan dan pengalaman di RS lain mempunyai pengaruh terhadap kepuasan pasien.

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Nowadays the hospital success is measured in present ate quality service. The quality service is related to the patient satisfaction. The Patient satisfaction is seen on expectation and the need to service that they accept.

The put-posed of this thesis to find out the information about the quality service, with patients satisfactory indicator in its relationship with nursing aspect as doctor, nurse service, financial administration and convenience. besides to measure influence on patient characteristic which is age, gender, education, occupation, knowledge, address (distance), welfare, experience at any other hospital and the insurer cost.

The research performed basely by various complaint and also criticism to musing service. This research was analytic descriptive and cross sectional quantitative. Primary data collected through by questioner to 206 respondents through interviews, up to 25 working days on the second week on May until the second week on June 2008.

The research result found the respondent declares for feeling pleasant to all service aspect which is analyzed as 59.7%. From service aspect and patient characteristic apparently hygiene - convenience aspect, distance, welfare and experience at any other hospital have influence to patient satisfaction. Experience aspect at any other hospital most dominant regard influence patient satisfaction (OR = 4,0l3)."

"Tesis ini membahas pengaruh kepuasan pasien terhadap kunjungan ulang secara analitik kuantitatif dengan desain prospective cohort dilengkapi pendekatan kualitatif. Pengambilan sampel dengan consecutive sampling. Informan terdiri dari Direktur, kepala instalasi, dokter spesialis paru, perawat, dan pasien, Tingkat kepuasan pasien sebesar 88,59% clan kunjungan ulang 75,5%. Dimensi Reliability, Responsiveness, dan kepuasan total berhubungan signifikan dengan kunjugan ulang. Pada analisis multivariat tidak ada variabel perancu hubungan kepuasan dengan kunjungan ulang. Disarankan melengkapi penunjuk arah, optimalisasi Poliklinik DOTS, penyusunan SOP informasi dan komunikasi, penyimpanan berkas rekam medik disatukan dengan foto rontgent, alat komunikasi supaya bisa langsung terhubung ke semua bagian tanpa melalui operator.

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This thesis discusses the influence of patient satisfaction to re-visit with the quantitative and qualitative analytical approach, prospective cohort design. Sampling with consecutive sampling. Informants consisted of Director, head of the installation, tuberculosis specialist doctors, nurses, and patients. Level of patient satisfaction of 88.59% and 75.5% re-visit. Dimensions of Reliability, Responsiveness, and total satisfaction have significant associated with re-visit. In the multivariate analysis does not have confounding variable relationship satisfaction with the re-visit. Recommended a complete way, optimaliz.ation Clinic DOTS, SOP preparation of information and communication, medical record storage file together with image rontgent, means of communication that can be directly connected to all parts without going through the operator. "

"The Third Edition is one of two companion books on improving communication in medicine which together provide a comprehensive approach to teaching and learning communication skills throughout all levels of medical education in both specialist and family medicine. Since their publication, the first edition of this book and its companion, Teaching and Learning Communication Skills in Medicine, have become texts in communication skills teaching. This substantially expanded third edition has been fully updated in relation to the current literature and revised to reflect the explosion of research on healthcare communication since the second edition was published in 2004. It incorporates considerable evidence in support of the skills of the Calgary-Cambridge Guides, offering a comprehensive and now even more evidence-based delineation of the skills that make a difference when communicating with patients. It explores the specific skills of doctor-patient communication and provides wide-ranging evidence of the improvement that those skills can make to health outcome and everyday clinical practice. It is unique in providing a secure platform of core skills which represent the foundations of doctor-patient communication"

"This compendium of case studies on patient safety - told from the perspective of the patient and family - illustrates 24 stories of preventable health care errors that led to irreparable patient harm. The reader is guided through a structured analysis of the events, eliciting lessons learned and strategies for preventing similar events in the future. Learning objectives for each case facilitate the reader's development of a set of core competencies related to improving safety and quality of health care.Contents"