Abstract:
PURPOSE:This study aimed to test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions. METHODS:A single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test. RESULTS:The proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001). CONCLUSIONS:The present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.
journal_name
Eur J Clin Pharmacoljournal_title
European journal of clinical pharmacologyauthors
Koonrungsesomboon N,Tharavanij T,Phiphatpatthamaamphan K,Vilaichone RK,Manuwong S,Curry P,Siramolpiwat S,Punchaipornpon T,Kanitnate S,Tammachote N,Yamprasert R,Chanvimalueng W,Kaewkumpai R,Netanong S,Kitipawong P,Sritipsukhdoi
10.1007/s00228-016-2159-1subject
Has Abstractpub_date
2017-02-01 00:00:00pages
141-149issue
2eissn
0031-6970issn
1432-1041pii
10.1007/s00228-016-2159-1journal_volume
73pub_type
杂志文章,随机对照试验abstract:OBJECTIVES:Problem-oriented drug information is characterised by health professionals actively seeking drug information through various sources. In this study our objective was to determine the quality and impact of problem-oriented drug information among physicians. METHODS:Evaluation forms accompanying 163 written a...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-001-0386-5
更新日期:2002-02-01 00:00:00
abstract:OBJECTIVES:The study was conducted to investigate whether oral co-administration with citrus juices significantly affects the pharmacokinetics and/or pharmacodynamics of pranidipine, a new 1,4-dihydropyridine calcium antagonist, in healthy male subjects. Grapefruit juice and orange juice, which were both commercially a...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章
doi:10.1007/s002280050547
更新日期:1998-11-01 00:00:00
abstract::The pharmacokinetics of enprofylline, a new potent antiasthmatic, has been studied in 20 healthy, elderly subjects, aged 65 to 81 years, and in 7 young adult controls, aged 23 to 37 years. The dose of 1 mg/kg body weight was given as an i.v. infusion. Plasma levels of enprofylline were followed for about 7 h and urine...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00609959
更新日期:1987-01-01 00:00:00
abstract:OBJECTIVES:Evidence exists to suggest that diclofenac is metabolised by CYP2C9. The present study was undertaken in order to evaluate the effect of the single CYP2C9*3 variant on drug metabolism using diclofenac as a probe drug. METHODS:A single dose of diclofenac was administered orally to 12 healthy subjects in whom...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s002280050722
更新日期:2000-04-01 00:00:00
abstract::The effect of the aminoglycosides amikacin, gentamicin, netilmicin sisomicin and tobramycin on the proximal tubule of the human kidney was investigated in 78 healthy subjects. Fifteen adults were each given gentamicin, sisomicin or tobramycin 3 mg/kg bodyweight, 10 subjects received netilmicin 3 mg/kg or amikacin 15 m...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00609758
更新日期:1978-05-17 00:00:00
abstract:OBJECTIVES:A temporal relationship between the increasing use of antibiotics and the increasing levels of antibiotic resistance has been established for Streptococcus pneumoniae. There are also data that support the presence of a geographic correlation between the level of resistance and the pattern of use among differ...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-003-0724-x
更新日期:2004-04-01 00:00:00
abstract:PURPOSE:The aim of the study was to compare plasma concentrations of rifampicin (RMP), isoniazid (INH) and pyrazinamide (PZA) between tuberculosis (TB) patients with and without diabetes mellitus (DM). METHODS:Two-hour post-dosing concentrations of RMP, INH and PZA were determined in adult TB patients that were studie...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-016-2132-z
更新日期:2017-01-01 00:00:00
abstract::There is conflicting data in the literature as to whether subsensitivity of in-vivo beta 2-adrenoceptor (beta 2-AR) responses in patients with asthma is due to an endogenous defect of beta 2-AR or an effect of exogenous beta 2-agonist therapy. The purpose of the study was to compare in-vitro parameters of lymphocyte b...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00315310
更新日期:1993-01-01 00:00:00
abstract::Pharmacokinetic parameters of prazosin (t1/2, tmax, Cmax and AUC have been studied in 18 hypertensive patients with varying degrees of chronic renal failure (serum creatinine ranging from 1.6 to 11.4 mg/dl). An oral dose of 2 mg of prazosin was added to the preexisting antihypertensive medication. The degree of renal ...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00981133
更新日期:1986-01-01 00:00:00
abstract:PURPOSE:Tolcapone is an efficacious catechol-O-methyltransferase inhibitor for Parkinson's disease (PD). However, safety issues hampered its use in clinical practice. We aimed to provide evidence of safety and efficacy of tolcapone by a systematic literature review to support clinicians' choices in the use of an enlarg...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章,评审
doi:10.1007/s00228-020-03081-x
更新日期:2021-01-07 00:00:00
abstract::In a multicentre, double-blind, crossover, placebo-controlled study, the antihypertensive effect of labetalol 100 mg and chlorthalidone 10 mg, given alone or in combination, has been assessed in 32 hypertensive patients. The combination had a greater effect in reducing blood pressure than did its separate components. ...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/BF00548395
更新日期:1982-01-01 00:00:00
abstract:CONTEXT:Adverse drug reactions (ADRs) are responsible for 5 % of hospital admissions, but hospital re-admission induced by ADRs remains poorly documented. OBJECTIVE:The aim of this study was to estimate the rate of hospital re-admission and the factors associated with re-admission in the patients over the age of 65 ye...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-016-2022-4
更新日期:2016-05-01 00:00:00
abstract:PURPOSE:The study aimed to describe the dispensing of benzodiazepines and benzodiazepine-related drugs (z-hypnotics) to pregnant women and to study the characteristics of these women and the extent of co-medication. METHODS:A population-based cohort study was conducted based on the linkage of nationwide registries: th...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-014-1744-4
更新日期:2014-11-01 00:00:00
abstract::The pharmacokinetics of metoclopramide has been studied after acute IV administration to 12 patients with hepatic cirrhosis (6 with and 6 without ascites) and 6 control subjects. The elimination half-life was significantly longer in patients (11.4 h and 9.9 h in those with and without ascites, respectively, vs 6.4 h i...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00265857
更新日期:1991-01-01 00:00:00
abstract:PURPOSE:We previously reported that chronic heart failure (CHF) treatments reduce the duration of hospitalisation, even in elderly patients. The present study aimed to determine whether CHF treatment also provides long-term benefits in terms of reduced mortality at 8 years. METHODS:A cohort of 281 patients who were ad...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-012-1400-9
更新日期:2013-04-01 00:00:00
abstract:OBJECTIVE:To assess the initial uptake in use and co-prescribing patterns of sildenafil. METHODS:We examined prescription details of the Eastern Health Board Region (including Dublin) of the General Medical Services (GMS) in Ireland, which provides detail on prescriptions dispensed in primary care for this population ...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s002280000255
更新日期:2001-03-01 00:00:00
abstract:OBJECTIVE:To investigate whether an association between the use of selective serotonin reuptake inhibitor (SSRI) antidepressants and abnormal bleeding is demonstrated in a large population study. METHODS:An observational cohort study using cohorts from the Drug Safety Research Unit's prescription event monitoring data...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s002280100263
更新日期:2001-05-01 00:00:00
abstract:OBJECTIVE:We investigated the effects of treatment with Saint John's wort (hypericum perforatum) extract on the urinary excretion of D-glucaric acid, 6beta-hydroxycortisol, and free cortisol in order to assess the effect of this extract on the activity of hepatic xenobiotic metabolizing enzymes. METHODS:Forty-eight he...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章
doi:10.1007/s00228-002-0527-5
更新日期:2002-12-01 00:00:00
abstract::The pharmacokinetics of a single 2 mg IV dose of chlordesmethyldiazepam has been studied in 11 patients with renal failure on regular haemodialysis and in 11 age-matched healthy controls. The kinetics was also examined after a single 2 mg oral dose in 6 of the 11 renal failure patients. After intravenous administratio...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00280109
更新日期:1991-01-01 00:00:00
abstract::The effects of a beta-blocker, carvedilol, on peripheral hemodynamics and hemorheologic parameters were evaluated in 11 geriatric patients with essential hypertension [3 men and 8 women aged 62-79 years (mean, 68.6 years)]. Carvedilol was given orally after breakfast at a dose of 10 or 20 mg daily for 8 weeks. Periphe...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF01409478
更新日期:1990-01-01 00:00:00
abstract:PURPOSE:To investigate adherence rates to hospital drug formularies (HDFs) and cost of drugs in hospitals. METHODS:Data on drugs used during 2010 were analyzed for ten hospitals (two hospitals from each of the five regions), constituting 30 % of hospitals and 45 % of hospital beds in Denmark. Drug use data from indivi...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-013-1540-6
更新日期:2013-10-01 00:00:00
abstract::The pharmacokinetic behaviour of cefadroxil was dose-dependent in healthy male volunteers following the oral administration of single doses of 5, 15, and 30 mg.kg-1. As the dose of cefadroxil increased from 5 to 15 and 30 mg.kg-1, the peak plasma concentrations, normalized to 5 mg.kg-1, decreased significantly from 15...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/BF00265914
更新日期:1991-01-01 00:00:00
abstract:PURPOSE:The antihypertensive effect of angiotensin-converting enzyme inhibitors (ACEi) is attributed partially to increased nitric oxide bioavailability. It is possible that functional polymorphisms in endothelial nitric oxide synthase (eNOS) and bradykinin receptor B2 (BDKRB2) genes may affect the antihypertensive res...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章
doi:10.1007/s00228-012-1326-2
更新日期:2013-02-01 00:00:00
abstract:OBJECTIVE:To develop quality prescribing indicators for general practitioners (GPs) who are non-monitored and not included in pay-for-performance programs, and to determine compliance with incentivized and non-incentivized indicators. STUDY DESIGN:Descriptive cross sectional study. SETTING:Aljarafe Primary Health Car...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-013-1542-4
更新日期:2013-10-01 00:00:00
abstract:OBJECTIVE:To describe the quantitative and qualitative changes in the utilization of oral antihyperglycemic drugs (OAHDs) between 1998 and 2004 and to analyze patients' adherence to OAHD therapy. METHODS:We conducted a retrospective analysis of the electronic database of the Hungarian National Health Fund Administrati...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-005-0031-9
更新日期:2005-12-01 00:00:00
abstract::We have given 12 healthy subjects the H1-antihistamine ebastine (20 mg) or placebo in a double-blind, crossover study for one week each. The subjects were tested for drug effects on Day 6 of each period, and for interactions of ebastine with ethanol (0.8 g.kg-1) on Day 7. On both days, the testing runs were done at ba...
journal_title:European journal of clinical pharmacology
pub_type: 临床试验,杂志文章
doi:10.1007/BF01740667
更新日期:1992-01-01 00:00:00
abstract::We have studied the transfer of the analgesic ketorolac tromethamine into breast milk in ten women aged between 22 and 35 years. Ketorolac administration was started between 2 and 6 days after delivery. The breast milk was not fed to the infant because of maternal antibiotic use (6 patients) or because of jaundice of ...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00558080
更新日期:1989-01-01 00:00:00
abstract:OBJECTIVE:To analyse whether first-time use of antidepressants (incidence) and selection of TCAs (tricyclic antidepressants) versus new-generation drugs are associated with socio-economic status and psychiatric history. METHOD:We conducted a population-based cohort study using registry data covering Funen County, Denm...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/s00228-003-0723-y
更新日期:2004-03-01 00:00:00
abstract:AIMS:Thiazolidinediones administration is assumed to be related with an improvement of endothelial dysfunction (ED); nevertheless, previous studies have been inconsistent. For this reason, the present meta-analysis was directed to estimate if thiazolidinediones were related to endothelial dysfunction improvement by usi...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章,meta分析,评审
doi:10.1007/s00228-015-1999-4
更新日期:2016-04-01 00:00:00
abstract::The relationship between the serum protein binding of carbamazepine (CBZ) and carbamazepine-10,11 epoxide (CBZ-E) and the concentration of alpha 1-acid glycoprotein (AAG) and albumin (HSA) was examined in 39 CBZ-treated epileptic children aged 4 months to 12 years. A significant inverse correlation was found between t...
journal_title:European journal of clinical pharmacology
pub_type: 杂志文章
doi:10.1007/BF00547424
更新日期:1985-01-01 00:00:00