- How to conduct well-designed clinical research
-
Da Jung Kim, Song Yi Kil, Jongwon Son, Ho Sup Lee
-
Kosin Med J. 2022;37(3):187-191. Published online September 27, 2022
-
DOI: https://doi.org/10.7180/kmj.22.122
-
-
3,627
View
-
91
Download
-
7
Citations
-
Abstract
PDFPubReader ePub
- Clinicians and healthcare decision-makers conduct their clinical practice based on the results of clinical trials. However, some health problems remain unresolved; in such cases, further research is required. To ensure reliable research results, it is important to understand the study design and conduct well-designed clinical trials. Many study designs can be chosen within the two broad categories of observational and interventional. Clinical studies have a variety of designs, including case series, case-control, cross-sectional, and prospective and retrospective cohort studies. Well-designed clinical studies can clarify important differences between treatment options and provide data on long-term drug efficacy and safety. Interpreting the results of clinical trials can be difficult because weaknesses in research design, data collection methods, analytic methods, and reporting can compromise their value and usefulness. However, although randomized controlled trials are limited owing to ethical and practical issues, they are optimal for investigating the effects of therapy and establishing causality. Here we present an overview of different clinical research designs and review their advantages and limitations.
-
Citations
Citations to this article as recorded by
- Gastric cancer and metabolic syndrome
Hyeong Ho Jo Kosin Medical Journal.2024; 39(1): 26. CrossRef - Clinical efficacy and safety of autologous serum intramuscular injection in patients with mild-to-moderate atopic dermatitis: a prospective, open-label, uncontrolled study
Gil-Soon Choi, Jong Bin Park, Young-Ho Kim, Hee-Kyoo Kim Kosin Medical Journal.2024; 39(1): 51. CrossRef - Changes in parents’ health concerns by post-preterm birth period in South Korea: a cross-sectional study
Yu Jin Jung, Hun Ha Cho Child Health Nursing Research.2024; 30(2): 118. CrossRef - Current understanding of modulated electro-hyperthermia in cancer treatment
Sungmin Kim, Jesang Yu, Jihun Kang, Yunkyung Kim, Taek Yong Ko Kosin Medical Journal.2024; 39(3): 160. CrossRef - Basic knowledge of endoscopic retrograde cholangiopancreatography
Jung Wook Lee Kosin Medical Journal.2023; 38(4): 241. CrossRef - Evaluation of automated calibration and quality control processes using the Aptio total laboratory automation system
Namhee Kim, Yein Kim, Jeongeun Park, Jungsoo Choi, Hyunyong Hwang Kosin Medical Journal.2022; 37(4): 342. CrossRef - The effects of rebamipide, sucralfate, and rifaximin against inflammation and apoptosis in radiation-induced murine intestinal injury
Won Moon, Sangwook Lim, Yeonsoon Jung, Yuk Moon Heo, Seun Ja Park, Moo In Park, Sung Eun Kim, Jae Hyun Kim, Kyoungwon Jung Kosin Medical Journal.2022; 37(4): 320. CrossRef
- Retrospective analysis on the clinical efficacy of bevacizumab combined with FOLFOX4 in the first line treatment of metastatic colorectal cancer
-
Eun Mi Lee, Lee Chun Park, Ho Sup Lee, Seong Hoon Shin, Yang Soo Kim
-
Kosin Med J. 2017;32(2):170-178. Published online January 19, 2017
-
DOI: https://doi.org/10.7180/kmj.2017.32.2.170
-
-
Abstract
PDFPubReader ePub
- Objectives
The addition of bevacizumab to standard chemotherapy has been improved survival outcomes in patients with metastatic colorectal cancer. However, the combination of bevacizumab with oxaliplatin-based chemotherapy as first-line treatment showed limited survival benefit. The purpose of this study was to investigate the clinical efficacy and toxicity of the combination of bevacizumab to oxaliplatin and leucovorin (FOLFOX4) in the first-line treatment of patient with metastatic colorectal cancer.
MethodsBetween December 2004 and September 2009, medical records of patients who were diagnosed with metastatic colorectal cancer and received the first line chemotherapy with bevacizumab and FOLFOX4, were retrospectively reviewed.
ResultsA total of forty patients were analyzed. The median age of the patients was 55 years (range, 33-80), and 55% was male. The patients received a total of 206 cycles of therapy (median 4 cycles per patient; range 1 – 15 cycles). Of these 40 patients, none achieved complete response (CR) and 15 achieved a partial response (PR), for the overall response rate (ORR) 37.5% (95% CI, 22.5-52.5). Median progression free survival (PFS) was 6.9 months (95% CI, 3.4-10.5) and median overall survival (OS) was 22.6 months (95% CI, 17.3-27.8The most common grade 3 or 4 hematologic toxicity and non-hematologic toxicity were neutropenia (10.0%) and diarrhea (10.0%), respectively. Two patients experienced gastrointestinal perforation.
ConclusionsIn this study, the combination bevacizumab with FOLFOX4 was associated with favorable OS, but did not showed favorable PFS and ORR.
- Prognostic Significance of Neutrophil Lymphocyte Ratio and Platelet Lymphocyte Ratio in Diffuse Large B-Cell Lymphoma Patients Treated with R-CHOP
-
Lee Chun Park, Ho Sup Lee, Eun Mi Lee, Seong Hoon Shin, Yang Soo Kim
-
Kosin Med J. 2016;31(2):122-133. Published online January 20, 2016
-
DOI: https://doi.org/10.7180/kmj.2016.31.2.122
-
-
1,382
View
-
2
Download
-
2
Citations
-
Abstract
PDFPubReader ePub
- Abstract
Objectives
The both values of neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR) were reported as indexes of systemic inflammation and readily available and inexpensive prognostic markers in patients with solid cancer. The objective of this study was to clarify whether the NLR and PLR were significant prognostic markers in Korean diffuse large B-cell lymphoma (DLBCL) patients treated with R-CHOP as a first line therapy.
Methods
: We retrospectively collected the clinical data of ninety nine DLBCL patients treated with R-CHOP from 2004 to 2012 and analyzed. NLR and PLR were calculated from complete blood count (CBC) and differential leukocyte count.
Results
: In univariate analysis, NLR was significantly associated with 5-year progression free survival(PFS) rate (P= 0.039), but not significantly associated with 5-year overal survival (OS) rate (P= 0.276). PLR was not significantly associated with 5-year PFS (P= 0.632) and OS rate (P= 0.855). In multivariate analysis, NLR was not a significant independent prognostic factor for 5-year PFS (P= 0.415) and OS rate (P= 0.991).
Conclusion
: The NLR can be considered a useful predictor of survival outcome. The PLR is not a valid predictor of survival outcome.
-
Citations
Citations to this article as recorded by
- Prognostic Role of Neutrophil to Lymphocyte Ratio at Diagnosis in Patients with Diffuse Large B-Cell Lymphoma
G Korkmaz, F Ceran, S Dağdaş, AK Güneş, C Sunu, MS Pepeler, M Pamukçuoğlu, G Özet Nigerian Journal of Clinical Practice.2024; 27(8): 1012. CrossRef - Prognostic role of neutrophil-to-lymphocyte ratio in diffuse large B cell lymphoma patients: an updated dose–response meta-analysis
Shidai Mu, Lisha Ai, Fengjuan Fan, You Qin, Chunyan Sun, Yu Hu Cancer Cell International.2018;[Epub] CrossRef
- Therapeutic comparison of Surgery combined with chemotherapy and chemotherapy alone for Primary Gastrointestinal Lymphoma: A single center study
-
Je Hun Kim, Ho Sup Lee, Jun Seop Lee, Jin Young Lee, Su Young Kim, Cheol Su Kim, Joung Wook Yang, Ga In You
-
Kosin Med J. 2015;30(1):29-39. Published online January 20, 2015
-
DOI: https://doi.org/10.7180/kmj.2015.30.1.29
-
-
Abstract
PDFPubReader ePub
- Abstract
Objectives
There is still no consensus on the optimal treatment for primary gastrointestinal lymphoma (PGIL). The aim of this study was to compare surgery combined with chemotherapy and chemotherapy alone in PGIL.
Methods
We retrospectively reviewed and analyzed the treatment outcomes of 107 patients with primary gastrointestinal lymphoma diagnosed between March 1999 and December 2009 at Kosin University Gospel Hospital. Patients were divided into two groups: 35 patients who underwent surgery combined with chemotherapy (group A) and 72 patients who were treated with chemotherapy alone (group B). And we analyzed prognostic factors associated with short survival.
Results
The 5-year progression free survival rates (PFS) of group A and B were 86.7% and 66.1%, respectively (P = 0.037), while the 5-year overall survival rates (OS) were 86.8% and 68.4%, respectively (P = 0.129). In multivariate analysis, Both PFS and OS were not changed by treatment strategies (surgery combined with chemotherapy or chemotherapy only). The international prognostic index (IPI) was the only independent predictive factor for PFS.
Conclusions
In our study, surgery combined with chemotherapy and chemotherapy only make no difference of survival rate. And further randomized prospective studies are needed to confirm a treatment strategies at improving survival outcomes in PGIL patients.
- Herpesviridae Viral Infections Following Stem Cell Transplantation in Hematologic Malignancy
-
Ho Sup Lee, Hee Sang Tag, Seong Hoon Shin, Yang Soo Kim, Sung Jin Nam, Hye Soo Kim, Jin Hee Park, Su Hyeon Jeong, Sung Bin Kim, Ye Na Kim
-
Kosin Med J. 2010;25(1):20-26. Published online June 30, 2010
-
-
-
PDF
- A Case of Acute Myeloid Leukemia with BCR-ABL Fusion Gene
-
Jung Min Choi, Sung Eun Song, Gyu Jin Lee, Gyu Won Lee, Ho Sup Lee
-
Kosin Med J. 2009;24(1):161-163. Published online June 30, 2009
-
-
-
PDF
|