Evidence, Belief, and Action: The Failure of Equipoise to Resolve the Ethical Tension in the Randomized Clinical Trial

2002 ◽  
Vol 30 (3) ◽  
pp. 375-380 ◽  
Author(s):  
Deborah Hellman

Clinical research employing the randomized clinical trial has, traditionally, been understood to pose an ethical dilemma. On the one hand, each patient ought to get the treatment that best meets her needs, as judged by the patient in consultation with her doctor. On the other hand, the method most helpful to advancing our understanding about what treatments are indeed best able to meet patient needs is the randomized trial, which necessitates that each patient's care is decided not by physician judgment or patient choice but instead by random assignment. The tension can be described as a conflict between the interests of individual patients who are sick today, and the interests of the group of people who will become sick in the future and would benefit from advances in medical understanding. How one ought to balance these important and often competing interests is an important ethical question that resists easy resolution.

Author(s):  
Santa Maria ◽  
Heriyadi Manan ◽  
Adenan Abadi ◽  
Theodorus Theodorus

Abstract Objective: To find out the comparison of the effect of one-rod and two-rod levonorgestrel implants on FSH, estradiol levels and increase in acceptor lipid profile after a 3-month evaluation in the Mother Hospital of Rika Amelia Palembang.Methods: This study was a phase III clinical trial, "Open" (Open Randomized Clinical Trial), carried out randomization by comparing two types of implant KB, namely levonorgestrel implants, one rod with two rods. This research was conducted at the RSAB Rika Amelia Palembang. Research time is 6 months from November 2018 - April 2019 or until the number of samples is fulfilled.Results: Based on the installation time, the average installation time using one rods LNG was 1.54 ± 0.11 minutes and the LNG for the two rods was 2.49 ± 0.26 minutes. Majority of patients having a normal blood pressure of 89.5% in one rod LNG and 68.4% in two rod LNG. The mean body mass index (BMI) of respondents using LNG implants one rod was 24.19 ± 3.93 kg / m2 and LNG for two rods was 25.09 ± 6.11 kg / m2. Based on the menstrual pattern, it was found that 84.2% of the subjects had regular menstrual patterns in the one-rod LNG group, while there were 63.2 % of subjects who have irregular menstrual patterns. From the statistical test, it was found that there were no differences in cholesterol levels (p = 0.919), HDL (p = 0.793), LDL (p = 0.851) and triglycerides (p = 0.679). There were no differences in FSH levels between respondents using one rod and two rod LNG implants (p = 0.849) and also on estradiol (p = 0.099)Conclusion: There is no difference between the use of one-rod and two-rodlevonorgestrel implants against FSH, Estradiol levels and increased lipid profile after 3 months of implant installation. The unpleasant effect in this study was the decline in HDL, but this was accompanied by a decrease in body weight, total cholesterol, LDL, HDL due to a decrease in all aspects.Keyword: estradiol, FSH, implant contraception, lenovorgestrel, lipid profile, one-rod, two-rod   Abstrak Tujuan:Untuk mengetahui perbandingan efek implanlevonorgestrel satu-batang dan dua-batang pada FSH, kadar estradiol dan peningkatan profil lipid akseptor setelah evaluasi 3 bulan di Rumah Sakit Ibu Rika Amelia Palembang.Metode: Penelitian ini adalah uji klinis fase III, "Open" (Open Randomized Clinical Trial), yang dilakukan secara acak dengan membandingkan dua jenis KB implan, yaitu levonorgestrel implan, satu batang dengan dua batang. Penelitian ini dilakukan di RSAB Rika Amelia Palembang. Waktu penelitian adalah 6 bulan dari November 2018 - April 2019 atau hingga jumlah sampel terpenuhi.Hasil :Berdasarkan waktu pemasangan didapatkan rerata waktu pemasangan yang menggunakan LNG satubatangadalah 1,54±0,11 menitdanpada LNG dua batang adalah 2,49±0,26 menit. Mayoritas pasien memiliki tekanan darah yang normal 89.5% pada LNG satu batang dan 68.4% pada LNG dua batang. Rerata indeks massa tubuh (IMT) responden yang menggunakan implan LNG satu batang sebesar 24,19 ± 3,93 kg/m2 dan LNG dua batang sebesar 25,09 ± 6,11 kg/m2. Berdasarkan pola haid, didapatkan sebanyak 84,2% subjek yang memiliki pola haid teratur pada kelompok LNG satu batang, sedangkan terdapat sebanyak 63,2% subjek yang memiliki pola haid tidak teratur. Dari uji statistik didapatkan bahwa tidak terdapat perbedaan kadar kolesterol (p = 0,919), HDL (p = 0,793), LDL (p = 0,851) dan trigliserida (p = 0,679). Tidak terdapat perbedaan kadar FSH antara responden yang menggunakan implan LNG satu batang dan dua batang (p = 0,849) dan juga pada estradiol (p=0.099)Kesimpulan: Tidak terdapat perbedaan antara penggunaan implan levonorgestrel satu batang dan dua batang terhadap kadar FSH, Estradiol serta peningkatan profil lipid setelah 3 bulan pemasangan implan. Efek yang tidak menyenangkan dalam penelitian ini adalah terjaidnya penurunan HDL, namun hal ini disertai dengan penurunan berat badan, kolesterol total, LDL, HDL dikarenakan terjadi penurunan pada seluruh aspek.Kata Kunci: dua batang, estradiol, FSH, kontrasepsi implan, lenovorgestrel, profil lipid, satu  batang.  


2021 ◽  
Author(s):  
Nader Nassiri ◽  
Mansoor Shahriari ◽  
Mansoor Azemati ◽  
Arvin Porkar rezaeyeh ◽  
Ali Azemati ◽  
...  

Abstract Purpose: Trans- photorefractive keratectomy (tPRK) technique using the Amaris laser is an alternative and modified method for PRK in correction of mild to moderate myopia. We assessed and compare the clinical sequels of the two techniques. Methods: This randomized clinical trial was conducted on 60 consecutive suffering moderate grades of myopia patients referred to Vanak Ophthalmology Clinic in 2020. The patients were randomly assigned to operate as both eyes of one patient by tPRK method (using Wong baker scale) and both eyes of another patient were by PRK method. Results: The change in patients' vision (UCVA, BCVA) in one and three months of follow-up in both groups was significant compared to preoperative values, but the rate of vision improvement was significantly better than before surgery in the tPRK group. There was no statistically significant difference between the two groups in terms of average refraction score, except for the sphere difference in one month follow-up. The mean Spherical Equivalent change in the PRK group in the one-month follow-up was 1.68 ± 1.00 and in the opposite group was 4.12 ± 0.92, indicating a better improvement in the tPRK group. There was less haziness in patients in the tPRK group than those in the PRK group. The patients undergoing tPRK experienced significantly less pain than another group. There is no difference between the two groups after surgery regarding intraocular pressure. Conclusion: The results of our study showed the superiority of the tPRK method over the PRK in correcting mild to moderate myopia


2002 ◽  
Vol 89 (2) ◽  
pp. 154-157 ◽  
Author(s):  
F. F Palazzo ◽  
D. L Francis ◽  
M. A Clifton

2001 ◽  
Vol 120 (5) ◽  
pp. A453-A453 ◽  
Author(s):  
B SHEN ◽  
J ACHKAR ◽  
B LASHNER ◽  
A ORMSBY ◽  
F REMZI ◽  
...  

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