Abstract：
PURPOSE:To assess, with all available trial information, whether the assessment of the PRECIS-2 nine domains could provide a clear distinction between medicine masked pragmatic randomized controlled trials (pRCTs) and open-label pRCTs. METHODS:A search was conducted of participant-level pRCTs on medicines published on 25 influential medical journals in July 2018-December 2019. All pre-licensing (phases 1-3) and cluster pRCTs were excluded. All trials' available reports were searched through the published article information, Google Scholar, and trial websites. Instead of providing a score to each PRECIS-2 domain, these were classified as E (explanatory), N (neutral), or P (pragmatic). RESULTS:Of 128 pRCTs, 18 (14%) were participant-level pRCTs on medicines. The full trial protocol was available for 14 trials; 12 had published the protocol and nine had additional reports published. All trials were prospectively registered, and none was funded by industry. Ten and eight were masked and open-label trials, respectively. Masked pRCTS had 34% of pragmatic and 60% of explanatory domains; open-label pRCTS had 45% pragmatic and 45% explanatory domains. Among the 10 masked trials, only one had a majority of five pragmatic domains; among the eight open-label trials, four had a majority of six or five pragmatic domains. "Follow-up" was considered explanatory in the 18 pRCTs; "primary analysis" was pragmatic in 17 pRCTs. CONCLUSION:The PRECIS-2 tool seems not to be sensitive enough to clearly discriminate between medicine masked pRCTs and open-label pRCTs. When conducting systematic reviews, it is suggested that the PRECIS-2 tool should not be used to support placing masked trials in the pragmatic side of the explanatory/pragmatic continuum.
journal_name
Eur J Clin Pharmacoljournal_title
European journal of clinical pharmacologyauthors
Dal-Ré Rdoi
10.1007/s00228-020-03030-8subject
Has Abstractpub_date
2020-10-26 00:00:00eissn
0031-6970issn
1432-1041pii
10.1007/s00228-020-03030-8pub_type
杂志文章abstract：PURPOSE:Treatment with statins requires close monitoring of serum creatine kinase (CK) levels to prevent myopathy, a common and potentially serious dose-dependent adverse effect of these drugs. We have investigated the correlation between elevated CK levels and polymorphisms in the genes encoding transporters involved ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-014-1661-6
更新日期：2014-05-01 00:00:00
abstract：OBJECTIVE:Little is known about patient compliance with oral adjuvant chemotherapy. It is estimated to be poor especially in Japan, where it is still unusual for patients to be directly informed of their diagnosis of malignancy. 5-Fluorouracil (5-FU) was measured in hair samples to assess patient exposure to 5-FU, and ...
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/s002280050077
更新日期：1996-01-01 00:00:00
abstract：PURPOSE:The use of melatonin is increasing among Swedish children and adolescents despite deficient knowledge of usage in these groups. The aim of this study was to investigate the use of melatonin in Swedish children and adolescents according to age, gender, dosage, treatment duration, and use of attention deficit hyp...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-015-1866-3
更新日期：2015-07-01 00:00:00
abstract：PURPOSE:Preparation of parenteral medication in hospitals is a complex process with a risk of microbial contamination of the product, especially when inappropriately prepared. Contaminated parenteral medications can cause severe complications to patients and increase morbidity in hospitals. The aim of this literature r...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,meta分析,评审
doi：10.1007/s00228-019-02631-2
更新日期：2019-05-01 00:00:00
abstract：OBJECTIVE:To examine the impact of medication and medical conditions on the fall risk in older hospitalized patients. DESIGN:Matched case-control study. SETTING:Large regional hospital in a mid-sized German city. SUBJECTS:Four hundred eighty-one inpatients aged ≥ 65 years who fell during hospitalization ("cases") an...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-019-02668-3
更新日期：2019-08-01 00:00:00
abstract：OBJECTIVES:To study the frequency of corticosteroid therapy and the use of inpatient care for preschool children with wheezing in two regions in Finland. METHODS:The Finnish Social Insurance Institution database on refundable asthma medication indicated that 1.18% of children in Tampere and 2.37% in Turku used inhaled...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s002280000199
更新日期：2000-11-01 00:00:00
abstract：:Total beta-adrenoceptor density and beta 1- and beta 2-subtype distribution in right and left atria and in different ventricular regions from 14 failing and seven nonfailing human hearts have been compared. End-stage heart failure was due to idiopathic dilated cardiomyopathy (n = 8) or ischaemic cardiomyopathy (n = 6)...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00265923
更新日期：1992-01-01 00:00:00
abstract：:The pharmacokinetics of 3H-16-epi-gitoxin have been investigated after oral administration: The peak serum level occurred after 30-60 min, and its subsequent decline was in two phases with half-lives of 3.5 and 19.5 h, respectively. Within 3 days 66-70% of the administered radioactivity were eliminated by renal excret...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00562938
更新日期：1977-07-19 00:00:00
abstract：OBJECTIVE:To investigate the effect of grapefruit juice (GJ) on the pharmacokinetics of orally administered verapamil in hypertensive patients. METHODS:Ten hypertensive patients on chronic verapamil treatment participated in a two-day study. On day 1 200 ml of water was given 1 hour before, and together with the morni...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s002280050470
更新日期：1998-06-01 00:00:00
abstract：:We gave 24 healthy elderly volunteers with a perceived sleep onset of at least 30 minutes zolpidem 5 mg, zolpidem 10 mg, or placebo for 7 days in a double-blind, three-way, crossover study. The morning after nocturnal dosing, psychomotor performance and cognitive ability were measured using tests which are sensitive t...
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/BF02284957
更新日期：1992-01-01 00:00:00
abstract：PURPOSE:To assess the influence of the P450 oxidoreductase 28 SNP (POR 28) on tacrolimus pharmacokinetics in the Chinese population. METHODS:Seventy-one healthy Chinese volunteers enrolled in the study received an oral dose of 2 mg of tacrolimus after providing written informed consent. CYP3A5 3 was genotyped by polym...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s00228-012-1432-1
更新日期：2013-04-01 00:00:00
abstract：:The pharmacokinetics of fluocortolone and its effect on the circadian rhythm of plasma cortisol and ACTH have been studied during different schedules of oral administration. Groups of 6 healthy male adults were given a single daily dose of fluocortolone 5, 10 and 20 mg, and another group received 20 mg every second da...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00609249
更新日期：1988-01-01 00:00:00
abstract：PURPOSE:Ticagrelor is a reversibly binding P2Y12 receptor antagonist for the prevention of atherothrombotic events in patients with acute coronary syndrome. Previous in vitro studies showed that ticagrelor is a substrate and inhibitor of P-glycoprotein (ABCB1). Therefore, we examined the potential interaction between d...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,随机对照试验
doi：10.1007/s00228-013-1543-3
更新日期：2013-10-01 00:00:00
abstract：:The effect of spironolactone on cardiac contractility indices was studied by externally recording systolic time intervals in four digitalized and four non-digitalized patients with ischaemic heart disease. A negative inotropic effect was found after spironolactone 100mg b.i.d. in all eight patients, as measured by an ...
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/BF00637612
更新日期：1982-01-01 00:00:00
abstract：PURPOSE:The aims of this study were to quantify the behavioural determinants of health professional reporting of medication errors in the United Arab Emirates (UAE) and to explore any differences between respondents. METHODS:A cross-sectional survey of patient-facing doctors, nurses and pharmacists within three major ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-016-2124-z
更新日期：2016-11-01 00:00:00
abstract：:The immediate haemodynamic and metabolic effects of acute dose of diazoxide 300 mg i.v. were studied in six healthy subjects at rest and during dynamic forearm exercise. Control periods of rest, exercise and recovery were compared with corresponding periods after drug administration. Resting forearm blood flow was alm...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00542454
更新日期：1982-01-01 00:00:00
abstract：:A randomised, placebo controlled clinical trial was conducted to examine the efficacy of a homeopathic after-bite gel in the symptomatic relief of mosquito bites. Sixty eight healthy volunteers were bitten under laboratory conditions by Aedes aegypti mosquitoes at three spots, on the ventral aspect of the forearm. One...
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/BF00192367
更新日期：1995-01-01 00:00:00
abstract：:The use of bioelectrical impedance (BI) analysis as a non-invasive approach for individualizing gentamicin therapy in newborn infants has been investigated in a two phase study. In Phase I, 1/impedance and length were identified as statistically significant predictors of the distribution volume of gentamicin (Adj R2 =...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00271367
更新日期：1993-01-01 00:00:00
abstract：:Seventeen normotensive, premenopausal women were treated with the 5-hydroxytryptamine-reuptake inhibitor dexfenfluramine 30 mg per day, for 4 days in a randomised double-blind, cross-over, placebo controlled trial. Energy intake was held constant during the study as the aim was to study the endocrine and metabolic eff...
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/BF00315204
更新日期：1991-01-01 00:00:00
abstract：PURPOSE:To gain insight into the experiences and handling of adverse drug reactions (ADRs) by the staffs of public primary healthcare (PHC) clinics in Eastern Cape Province, South Africa, as well as their perceptions of related adherence challenges in the treatment and follow-up of human immunodeficiency virus (HIV)-po...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-012-1254-1
更新日期：2012-09-01 00:00:00
abstract：AIM:To analyse the consumption of a number of medicines with a known potential for increasing the risk of road traffic accidents in the general population of Europe. METHODS:Questionnaires were distributed through the European Drug Utilization Research Group (EuroDURG) and Post-Innovation Learning through Life-events ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-009-0695-7
更新日期：2009-11-01 00:00:00
abstract：:The duration and extent of cardiac beta-blockade and their relationship to propranolol pharmacokinetics were assessed in nine healthy volunteers. Each subject received 160 mg of regular propranolol (R), 160 mg of sustained-release propranolol (SR) and no drug (control), both as single doses and once daily for 7 days. ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00637569
更新日期：1987-01-01 00:00:00
abstract：OBJECTIVE:The aim of our study was to investigate the effects of carbamazepine (CBZ) and oxcarbazepine (OXCBZ) on aminothiol levels, including homocysteine (Hcy), cysteine, and cysteinylglycine, in chronically treated patients. METHODS:Epileptic patients receiving CBZ or OXCBZ were recruited as part of routine clinica...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-007-0388-z
更新日期：2008-01-01 00:00:00
abstract：PURPOSE:Clomipramine is one of the drugs for depression during pregnancy; however, pharmacokinetic data of clomipramine and its active metabolite desmethylclomipramine in this vulnerable period are lacking. In this study, we describe clomipramine and desmethylclomipramine concentrations including their ratios during pr...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-015-1944-6
更新日期：2015-12-01 00:00:00
abstract：OBJECTIVE:The aim of this study was to define the pharmacokinetic profile of free carbamazepine (F-CBZ) in adult Omani epileptic patients in order to improve on dosing schedules through population pharmacokinetic analysis using the NONMEM program. METHOD:Steady-state trough F-CBZ serum concentrations, carbamazepine (C...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/s002280100300
更新日期：2001-06-01 00:00:00
abstract：PURPOSE:Persistence to statins is low, in part due to lack of perception of cardiovascular (CV) risk. High values of low-density lipoprotein cholesterol (LDL-C) might increase the motivation for patients to be persistent. We investigated whether the baseline LDL-C value influences the discontinuation of statin treatmen...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-015-1996-7
更新日期：2016-03-01 00:00:00
abstract：:The pharmacokinetics of oral L-threo-3,4-dihydroxyphenylserine (L-threo-DOPS) was studied in 7 normal subjects and 7 patients with familial amyloid polyneuropathy. Each person swallowed a single 300 mg dose in the fasting state, and L-threo-DOPS in plasma and urine was determined by high performance liquid chromatogra...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00605999
更新日期：1982-01-01 00:00:00
abstract：PURPOSE:Our aim was to observe the impact of CYP3A4*1G genetic polymorphism on lipid-lowering efficacy of statins. METHODS:We studied 217 unrelated hyperlipidemic patients who prospectively received atorvastatin and 199 patients who received simvastatin as a single-agent therapy (20 mg day(-1) p.o.) for 4 weeks. Genot...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-008-0502-x
更新日期：2008-09-01 00:00:00
abstract：:In 6 normal volunteers given single oral doses of 250,500 and 1000 mg ticlopidine (T), the peak plasma level of unchanged drug was reached after about 2 h. There was no correlation between the plasma T level and its inhibitory effect on platelet function, expressed as % inhibition of ADP-induced aggregation. By means ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00626364
更新日期：1991-01-01 00:00:00
abstract：OBJECTIVE:To determine the pharmacokinetics and organ distribution of i.v. and oral methylene blue, which is used to prevent ifosfamide-induced encephalopathy in oncology. METHODS:The concentration of methylene blue in whole blood was measured using high-performance liquid chromatography in seven volunteers after i.v....
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s002280000124
更新日期：2000-06-01 00:00:00
