Methodologic Standards for Controlled Clinical Trials of Early Contact and Maternal-Infant Behavior

PEDIATRICS ◽  
1984 ◽  
Vol 73 (3) ◽  
pp. 294-300
Author(s):  
Mary Ellen Thomson ◽  
Michael S. Kramer

To provide an objective evaluation of published studies on the effect of early contact on subsequent maternal-infant behavior, a set of 11 methodologic standards generally applicable to controlled clinical trials of perinatal care was developed. Sixteen reports of early contact trials were assessed and seven of the 11 standards were found to be satisfactorily fulfilled. The four "problem" standards were: adequate definition of subjects, randomization, subject bias, and treatment contamination (care giver) bias. Of the five best trials fulfilling eight or more of the standards, three reported a beneficial effect of early contact, while two demonstrated no effect. The evidence that early contact improves subsequent maternal-infant behavior thus remains inconclusive. It is urged that for future research in this domain more attention be given to adequate subject definition, strict randomization procedures, and safeguards against bias by the subjects or their care givers.

1986 ◽  
Vol 7 (S2) ◽  
pp. 113-117 ◽  
Author(s):  
Dennis G. Maki

Whereas infections of the skin per se comprise only a fraction of all institutionally-acquired infections, the skin has become one of the most important reservoirs of nosocomial pathogens in the hospital. Professor Noble has provided a scholarly review of the increasing importance of the major constituents of the cutaneous microflora as nosocomial pathogens and what we know of their epidemiology. Unfortunately, the empiricism and limited scientific data which underlie essential infection control measures in this area, particularly in regard to cutaneous antisepsis and handwashing, is almost incongruous in an era in which controlled clinical trials have dominated most other areas of medicine. The numerous outbreaks traced to contaminated antiseptics and disinfectants over the past two decades, stand as mute testimony to the inadequate investigative attention this area has received.


Cephalalgia ◽  
2019 ◽  
Vol 39 (8) ◽  
pp. 1058-1066 ◽  
Author(s):  
Marie Deen ◽  
Daniele Martinelli ◽  
Judith Pijpers ◽  
Hans-Christoph Diener ◽  
Stephen Silberstein ◽  
...  

Introduction Since the definition of chronic migraine as a new disease entity in 2004, numerous clinical trials have examined the efficacy of preventive treatments in chronic migraine. Our aim was to assess the adherence of these trials to the Guidelines of the International Headache Society published in 2008. Methods We searched PubMed for controlled clinical trials investigating preventive treatment for chronic migraine in adults designed after the release of the Guidelines and published until December 2017. Trial quality was evaluated with a 13-item scoring system enlisting essential recommendations adapted from the Guidelines. Results Out of 3352 retrieved records, we included 16 papers in the analysis dealing with pharmacological treatment of chronic migraine. The median score was 6.5 (range 2–13). All trials were randomized, the large majority (81.25%) were placebo-controlled and double-blinded (87.5%). Adherence was lowest on i) a priori definition of outcomes (31.25%), ii) primary endpoint definition (37.5%%) and iii) trial registration (37.5%). Discussion Most clinical trials adhered to the recommendations of the IHS, whereas adherence to migraine-specific recommendations was lower. Greater awareness and adherence to the guidelines are essential to improve the quality of clinical trials, validity of publications and the generalizability of the results.


1996 ◽  
Vol 26 (5) ◽  
pp. 899-912 ◽  
Author(s):  
M. A. L. Van Tilburg ◽  
A. J. J. M. Vingerhoets ◽  
G. L. Van Heck

SynopsisHomesickness has not received due attention from psychological researchers, in spite of the fact that it is of considerable interest to counsellors and care-givers of those who have migrated or moved temporarily or permanently (e.g. immigrants, refugees, students, soldiers). First, this review addresses the definition of homesickness, the possible different kinds of homesickness, its prevalence rate, and symptomatology, Secondly, an overview is given of the theories that account for psychological distress following leaving home. These theories link homesickness with separation-anxiety and loss, the interruption of lifestyle, reduced control, role change, and internal conflict. In addition, the review focuses on: (i) studies that show that subjects reporting homesickness differ from non-homesick persons in terms of personality; (ii) the analyses of environmental characteristics that may play a crucial role in the onset and course of homesickness. Thirdly, Fisher's (1989) composite model of homesickness, which summarizes key findings of the major studies on homesickness is discussed. Fourthly, methodological issues are addressed. Finally, suggestions for future research are presented and possibilities for interventions are proposed.


Cephalalgia ◽  
1997 ◽  
Vol 17 (20_suppl) ◽  
pp. 35-38 ◽  
Author(s):  
F Granella ◽  
G Sances ◽  
G Messa ◽  
M De Marinis ◽  
Gc Manzoni

Because of its pathophysiological and clinical peculiarities, true menstrual migraine (MM) (i.e. migraine starting exclusively between the days immediately before and immediately after the first day of the menstrual cycle) requires an ad hoc management different from that of other migraines. The paucity of well-conducted, controlled clinical trials and the lack of a universally accepted definition of MM have meant that the treatment of MM is still largely empirical. In our clinical practice, we adopt a sequential therapeutic approach, including the following steps: (i) acute attack drugs (sumatriptan, ergot derivatives, NSAIDs); (ii) intermittent prophylaxis with ergot derivatives or NSAIDs; (iii) oestrogen supplementation with percutaneous or transdermal oestradiol (100 Lig patches); (iv) antioestrogen agents (danazol, tamoxifen).


Cephalalgia ◽  
1997 ◽  
Vol 17 (2) ◽  
pp. 113-118 ◽  
Author(s):  
C Keith Haddock ◽  
AB Rowan ◽  
F Andrasik ◽  
PG Wilson ◽  
G Wayne Talcott ◽  
...  

Controlled clinical trials have consistently demonstrated that behavioral treatments for chronic benign headache produce clinically beneficial outcomes both post-treatment and at follow-up. Given these results there is interest in cost-reduction and redesign of these treatments to improve their accessibility. One promising approach in this regard is home-based headache treatment. These treatments seek to provide the same amount of treatment as clinic-based treatments; however, some of the material typically presented to the patient by a clinician is presented through home-study materials (e.g., manuals, audiotapes). To date, the published literature contains 20 controlled clinical trials which have examined the outcomes produced by home-based treatments. This article presents the first comprehensive meta-analysis of these clinical outcome studies. Results of the quantitative analyses suggest that home-based treatments produce comparable, or with certain outcome measures, superior results to clinic-based treatments. Moreover, cost-effectiveness scores of home-based treatments were found to be more than five times larger than those of clinic-based therapies. Methodological analyses are also presented along with suggestions for future research.


2021 ◽  
Author(s):  
Diego Romario-Silva ◽  
Otavio Akira Souza Sakaguchi ◽  
Andrea Cristina Barbosa da Silva ◽  
Janaína Orlandi Sardi ◽  
Rafaela Parolina de Carvalho ◽  
...  

Probiotics are microorganisms that live in symbiosis with the human body. The intake of probiotics in adequate amounts can improve biological functions bringing improvements in the health of the host. Many studies have demonstrated the indisputable antimicrobial activity of probiotics and their potential for an alternative treatment of infections. Nevertheless, the forms of encapsulation, as well as clinical trials on the clinical use of these microorganisms as a recognized and well-established protocol, are still incipient. In this chapter, we provide a general approach to the topic and point to future directions in the probiotics field for this purpose. Moreover, microbial resistance is a current public health problem and the search for new therapeutic alternatives is urgent. Probiotics and other natural therapies have been considered very promising. The approaches of future research should focus mainly on the isolation of new probiotic microorganisms, the definition of inoculum, forms of encapsulation for controlled delivery, and clinical trials for the definition of doses and mechanism of action in the fight against infections.


2019 ◽  
Vol 29 (1) ◽  
pp. 74-102 ◽  
Author(s):  
Julia Hiemer ◽  
Maike Andresen

Socioeconomic panel data indicate that numerous employees would prefer to work less, i.e. that they are overemployed. However, due to inconsistent definitions and divergent operationalizations of overemployment, integrating existing research results is challenging and implications for research and practice are difficult to draw. To advance research in this field, we present an analysis of the concept and measurement of overemployment. To analyze the concept, we proceed in two steps. In step 1, we present the range of overemployment definitions in the literature and systematize the similarities and differences in these previous conceptualizations with the aim of arriving at an adequate definition of “overemployment.” In step 2, in view of the partial overlap between existing definitions of overemployment and other concepts used in past research, we demarcate overemployment from related concepts, identify conceptual distinctions between overemployment and other concepts and explore connections between concepts. To analyze the measurement of overemployment, we look at the bandwidth of content, measurement levels and question wording in overemployment measures and discuss the consequences of the different measures used for the overemployment rates found. We then present a consistent approach towards conceptualizing and measuring overemployment which aids future research on overemployment and similar concepts.


1987 ◽  
Vol 42 (12) ◽  
pp. 1132-1133
Author(s):  
Stanley D. Imber ◽  
Lawrence M. Glanz ◽  
Irene Elkin ◽  
Stuart M. Sotsky ◽  
Jenny L. Boyer ◽  
...  

Sign in / Sign up

Export Citation Format

Share Document