Analysis of randomized and nonrandomized patients in clinical trials using the comprehensive cohort follow-up study design

1992 ◽  
Vol 13 (3) ◽  
pp. 226-239 ◽  
Author(s):  
Manfred Olschewski ◽  
Martin Schumacher ◽  
Kathryn B. Davis
Keyword(s):  
Clinical Trials ◽  
Study Design ◽  
Follow Up Study

scholarly journals Design of a prospective follow-up study on early parenthood and smoking behaviour during pregnancy in Finnish primary healthcare

2021 ◽  
pp. 140349482110224
Author(s):  
Mikael O. Ekblad ◽  
Hanna P. Wallin ◽  
Marjukka Pajulo ◽  
Päivi E. Korhonen
Keyword(s):  
Pregnant Women ◽  
Study Design ◽  
Primary Healthcare ◽  
Routine Data ◽  
Smoking Behaviour ◽  
Self Report ◽  
Health Clinic ◽  
Follow Up Study ◽  
Study Population

Aims: The primary aim of the study is to explore different factors affecting parents’ smoking behaviour, and especially how smoking may be connected with individual differences in the psychological process of becoming a parent. In the current paper, we present the study design together with basic information on the study population. Methods: The Central Satakunta Maternity and Child Health Clinic (KESALATU) Study is an ongoing prospective follow-up study in primary healthcare of the Satakunta region of southwest Finland. Families were recruited during their first maternity clinic visit between 1 September 2016 and 31 December 2019, and participation will continue until the child is 1.5 years of age. The study combines different sources and types of data: e.g. routine data obtained from primary healthcare clinic records, specific parental self-report data and data from a new exhaled carbon monoxide meter indicating maternal smoking. The data are collected using frequently repeated assessments both during pregnancy and postnatally. The methods cover the following areas of interest: family background factors (including smoking and alcohol use), self-reported parental–foetal/infant attachment and mentalization, self-reported stress, depression and quality of life. Results: 589 pregnant women and their partners were asked to participate in the study during the collection time period. The final study population consisted of 248 (42.1%) pregnant women and 160 (27.1%) partners. Conclusions: The new methods and study design have the potential to increase our understanding about the link between early parenting psychology, prenatal psychosocial risk factors and parental health behaviour.

scholarly journals Intergenerational monitoring in clinical trials of germline gene editing

2019 ◽  
Vol 46 (3) ◽  
pp. 183-187 ◽  
Author(s):  
Bryan Cwik
Keyword(s):  
Clinical Trials ◽  
Gene Editing ◽  
Ethical Issues ◽  
Human Subjects ◽  
Germline Gene ◽  
Ethical Challenges ◽  
Human Subjects Research ◽  
Follow Up Study

Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerning intergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for clinical use thus may require intergenerational monitoring. The aim of this paper is to identify and argue for the significance of a set of ethical issues raised by intergenerational monitoring in future clinical trials of germline gene editing. Though long-term, multigenerational follow-up study of this kind is not without precedent, intergenerational monitoring in this context raises unique ethical challenges, challenges that go beyond existing protocols and standards for human subjects research. These challenges will need to be addressed if clinical trials of germline gene editing are ever pursued.

Experience and Reason: Twenty-Year Follow-Up of Protective Immunity of the Oka Strain Live Varicella Vaccine

PEDIATRICS ◽  
1994 ◽  
Vol 94 (4) ◽  
pp. 524-526
Author(s):  
Yoshizo Asano ◽  
Sadao Suga ◽  
Tetsushi Yoshikawa ◽  
Ikuko Kobayashi ◽  
Takehiko Yazaki ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Protective Immunity ◽  
Protective Efficacy ◽  
Varicella Vaccine ◽  
The United States ◽  
Follow Up Study ◽  
Waning Immunity

Since the first report on the development of a live attenuated varicella vaccine in 1974, the vaccine has been studied extensively, with largely favorable results, in both healthy and leukemic children. It is now licensed in Japan, Korea, and some European countries, and is being considered for licensure in the United States. Although various clinical trials have established the safety, immunogenicity, and the efficacy of the vaccine, concern has been expressed that waning immunity in the vaccine recipients might allow the occurrence of more severe varicella later in life. We show data relevant to this concern on the approximately 20-year follow-up study of the vaccine recipients; this work further extends the experience of a long-term protective efficacy of the vaccine.

Follow-up, study design and outcome parameters

2013 ◽  
Vol 9 (R) ◽  
pp. R96-R100 ◽  
Author(s):  
Massimo Volpe ◽  
Allegra Battistoni ◽  
Giuliano Tocci
Keyword(s):  
Study Design ◽  
Outcome Parameters ◽  
Follow Up Study

Guidelines for publishing papers on cancer clinical trials: responsibilities of editors and authors.

1983 ◽  
Vol 1 (2) ◽  
pp. 164-169 ◽  
Author(s):  
M Zelen
Keyword(s):  
Quality Control ◽  
Clinical Trials ◽  
Study Design ◽  
Journal Editor ◽  
Cancer Clinical Trials ◽  
Journal Editors ◽  
Early Results ◽  
Published Paper ◽  
Statistical Results

Guidelines are proposed for the reporting of clinical trials. These are meant to be used for both authors and journal editors. Specific proposals are made for: reporting the population under study, actual therapy used, describing the study design, accounting of patients, follow-up statistics, and describing the quality control of the data. Nonrandomized studies require special discussion. Such studies potentially have substantial biases which can lead to incorrect conclusions. Six areas of biases arising in nonrandomized studies are pointed out which should require a discussion in an acceptable published paper. The presentation of statistical results and the reporting of early studies present unusually difficult problems. Guidelines are presented for statistical analyses which, although simple to implement in practice, are not generally used. A proposal is made for the publication of early results of a study which require that the authors agree to follow and periodically report on their trial to the journal editor. If the early conclusions change with additional follow-up, the editor should notify its readers. The adoption of these guidelines can be an important force in raising the scientific level of the reporting of clinical trials.

BRAF inhibitor treatment in classic hairy cell leukemia: a long-term follow-up study of patients treated outside clinical trials

Leukemia ◽  
2019 ◽  
Vol 34 (5) ◽  
pp. 1454-1457
Author(s):  
Nora Liebers ◽  
Tobias Roider ◽  
Jan-Paul Bohn ◽  
Isabella Haberbosch ◽  
Andreas Pircher ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Hairy Cell Leukemia ◽  
Braf Inhibitor ◽  
Hairy Cell ◽  
Cell Leukemia ◽  
Follow Up Study ◽  
Long Term Follow Up ◽  
Inhibitor Treatment

SPANISH FAMILIAL HYPERCHOLESTEROLAEMIA (FH) COHORT FOLLOW-UP STUDY. DESIGN AND BASELINE CHARACTERISTICS

2008 ◽  
Vol 9 (1) ◽  
pp. 91
Author(s):  
R. Alonso ◽  
N. Mata ◽  
F. Fuentes ◽  
J. Villar ◽  
R. Figueras ◽  
...  
Keyword(s):  
Study Design ◽  
Familial Hypercholesterolaemia ◽  
Follow Up Study ◽  
Baseline Characteristics
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