Childhood eczema and asthma incidence and persistence: A cohort study from childhood to middle age (Cohort Study)

Francisco, Kaycee Allen Z. Gan, James Viktor A. 4CL-Ph

Background: The association between eczema and asthma is well documented, but the temporal sequence of this association has not been closely examined.
Objectives: To examine the association between childhood eczema and asthma incidence from preadolescence to middle age, and between childhood eczema and asthma persisting to middle age. A further aim was to examine any effect modification by nonallergic childhood exposures on the association between childhood eczema and both childhood asthma and later life incident asthma.

Methods: Data were gathered from the 1968, 1974, and 2004 surveys of the Tasmanian Longitudinal Health Study. Multivariable logistic regression examined the association between childhood eczema and childhood asthma. Cox regression examined the association between childhood eczema and asthma incidence in preadolescence, adolescence, and adult life. Binomial regression examined the association between childhood eczema and childhood asthma persisting to age 44 years.

Results: Childhood eczema was significantly associated with childhood asthma and with incident asthma in preadolescence (hazard ratio [HR], 1.70; 95% CI, 1.05-2.75), adolescence (HR, 2.14; 95% CI, 1.33-3.46), and adult life (HR, 1.63; 95% CI, 1.282.09). Although childhood eczema was significantly associated with asthma persisting from childhood to middle age (relative risk, 1.54; 95% CI, 1.17-2.04), this association was no longer evident when adjusted for allergic rhinitis. Conclusion: Childhood eczema increased the likelihood of childhood asthma, of new-onset asthma in later life and of asthma persisting into middle age. (J Allergy Clin Immunol 2008;122:280-5.)

OVERALL ASSESSMENT

Was the article published in a reputable, peerreviewed journal?

Yes

Published in the journal of allergy and clinical immunology (official publication of the American academy of allergy, asthma, and immunology)
Articles cover such topics as allergic and immunologic diseases, the latest therapies and treatment programs, occupational/industrial allergy, and studies of antigens, allergens, and the environment. The journal ranks 1st of 21 in the Allergy category and ranked 8th of 128 in the Immunology category on the 2011 Journal Citation Reports, published by Thomson Reuters.

Were the investigators qualified to conduct the study?

Yes
investigators (professionals and experts in their respective fields) They are affiliated with various reputable institutions such as the Centre for Molecular, Environmental, Genetic and Analytic Epidemiology, University of Melbourne, Carlton, Menzies Research Institute, University of Tasmania, Department of Epidemiology and Preventive Medicine, Monash University, and others.

Did the authors contribute substantially to the research effort?

Yes

The study was started on 1968 to determine the correlation of childhood eczema to the development of asthma.
The investigators continued this research until their latest findings on 2004. In which it took them 3 years to finish this paper in 2007. The entire research took approximately 39 years of monitoring and reviewing to complete. The length of time required to complete this study indicates the involvement of all the authors involved. Their difference in specialization allowed them to delegate their work such as surveying the participants, monitoring for risk of asthma, and statistical treatment of data.

Did the research site have appropriate resources and patients for the study?
Yes Aside from receiving funding from various private and government institutions, the participants that comprises the sample size of this study is 7383 participants during their first survey.

On their most current survey, 6998 out of the original 7383 were still involved which is a sizable number of participants.
This study also employed different statistical methods of analysis such as multivariable logistic regression, cox regression, and binomial regression when appropriate to assess the data obtained.

Was the study funding obtained from unbiased source?

Yes
Funding (National Health and Medical Research Council of Australia, the Victorian and Tasmanian Asthma Foundations, the Clifford Craig Medical Research Trust, and the Royal Hobart Hospital Research Foundation) reputable organizations granting and managing the complementary functions of funding health and medical research, and providing ethical guidance on health and medical research issues on behalf of the Australian Government. It is also supported by a Research Scholarship from the University of Melbourne.

Title/Abstract

Was the title of the article unbiased?

Yes The article provided a clear and simple statement of the concerns of the study which are eczema and asthma from childhood to middle age. The title does not indicate that it favors any kind of outcome that might result from this study.

Did the abstract provide a clear overview of the purpose, methods, results and conclusion of the study?
Yes
Concise details regarding the overview of the purpose, methods, results and conclusion of the study were presented systematically at the beginning of the paper.

Each part was presented clearly by stating briefly the important information regarding the research.

Introduction

Did the authors provide sufficient background information to demonstrate that the study was important and ethical?
Yes The background suggests that there is correlation between having eczema and developing asthma as a child. The authors would like to determine whether this propensity for asthma would still persist even in middle age; thus, the authors aim in finding out whether there is a correlation or not will provide a more comprehensive treatment for asthma in adults to improve their quality of life.

Were the study objectives clearly explained?

Yes The objectives of the study were indicated in the abstract. (to examine the association between childhood eczema and asthma incidence from preadolescence to middle age, and between childhood eczema and asthma persisting to middle age) A further aim was to examine any effect modification by nonallergic childhood exposures on the association between childhood eczema and both childhood asthma and later life incident asthma.

Were planned subgroup or covariate analyses indicated?

Yes
The section for the covariate analyses was indicated in the paper after the definition of terms.

This is to clarify any confusion that might result from the gathering of data.

Were the research and null hypotheses stated?

No

The research and null hypotheses were not stated in the study.

Was the study approved by and institutional review board (IRB)?

Yes
The study passed through the National Health and Medical Research Council of Australia. (a company which served as an independent ethics committee for the approval of the study)

Was the study ethical?

Yes
The study just conducted surveys and kept the records confidential.

No human and even animal subjects were harmed in the research.

Parental consent was solicited in behalf of the participants who were minors when this research began.

Methods

Was an appropriate study design used?

Yes
This research utilized an appropriate study design (providing surveys to its participants as main forms of data gathering). The questions in the survey clearly defined the state or extent of asthma that the participant has and even indicates covariable factors such as smoking, diet, and other lifestyle choices which might have affected the result of the study. The different statistical tests were used at the appropriate age groups to critically assess data.

 Multivariable logistic regression examined the association between childhood eczema and childhood asthma. Cox regression examined the association between childhood eczema and asthma incidence in preadolescence, adolescence, and adult life. Binomial regression examined the association between childhood eczemaand childhood asthma persisting to age 44 years.

Did the inclusion and exclusion criteria represent an appropriate patient population for the study?
No inclusion or exclusion criteria were mentioned in the study.

The only qualification to be a participant is that he/she had to be a child of age 7 when the survey was conducted.
Signs and occurrences of eczema and asthma were measured via surveys in 1968, 1974, and 2004 using the most of the participants originally involved.

Was the sample size large enough to detect a statistically significant difference between treatment groups?
Yes The sample size was approximately 7000 participants which is large enough to detect statistically significant difference between groups.

Was the study sample representative of the patient population to which the study results were intended to be generalized?
No
The participants were just Australians (attending school in Tasmania). Only one nationality was employed in the study which may not be applicable to other races. However, the appropriate age groups were covered but may not be that substantial to generalize the results.

Was the study controlled? Were the controls appropriate?

No controls were implemented in this study as it is inhumane and impossible to restrict the life of the participants for a time interval of years. The research compensated for the lack of controls by providing survey questions that addresses confounders, such as life style habits, so that they may be included in the final analysis of data gathered.

Were outcome variables relevant, clearly defined, objective, and clinically and biologically significant? Was methodology used to measure outcome variables described in detail? Were outcome variables measured at appropriate time intervals?
Yes
The outcome variables were clearly defined in this research and are clinically significant.

The answers of the participants in the survey forms were used to determine the level or degree of asthma which might have resulted from their exposure to childhood eczema.
Data gathering was conducted three times; once for different age groups of the participants. Considering the large number of sample size for this study. The number of times data was gathered is sufficient.

Was the study randomized using an appropriate method? After randomization, were demographics for treatment and control groups similar? There was no randomization involved in this study. The researchers chose a school in Tazmania with a large population and included every child at the age of 7 whose parents would consent to the involvement of their child in this research.

Were subjects, investigators, outcome assessors, and data entry personnel blinded? Were these individuals unable to determine whether treatment or control was administered before the blind was broken?

Blinding is not appropriate in this study as no investigational drug substance was to be tested on human subjects.

Were data collected appropriately?

Yes The data were gathered in a school in Tasmania where the survey was conducted.

The questionnaires completed by parents with details of their childs history of asthma, hay fever, eczema, food or medicine allergy, and urticaria were orderly collected taking into consideration the parents time and responsibilities.

Was patient compliance with the study medication measured?

No

There was no need to measure compliance as medication was not used in the study.

Were patient and investigator compliance with the study protocol monitored?

Were appropriate statistics used to analyze data?

Results

Were dates for study initiation and completion of the study provided? Is the study current and relevant?
Yes The dates from the beginning of the study to its completion were presented in the research methodology.

The research began in 1968 and ended in 2004.

Since the study was published on May 5, 2008, it can be concluded that the research isnt that current anymore.

However, we can consider the study as relevant since it is deemed beneficial to the children who might be encountering the same problem stated in the research. It was proven in the research that the effect of childhood eczema on asthma risk persists well past childhood. With that statement, we can recommend parents to have their children with eczema be treated aggressively to be able to prevent the development of asthma.

Were numbers of patients screened, enrolled, administered study treatment, completing, and withdrawing from the study reported? Were reasons for study withdrawal described? Yes In the research, on the first survey which began in 1964, there were 8,583 participants but only 8,237 completed the questionnaire. On another survey started in 2004, from the 6,998 participants, only 5,729 complied. The reasons for the study withdrawal were not directly stated but it can be assumed that the parents were busy with their responsibilities so they were not able to accomplish the questionnaires provided.

Were demographics for treatment and control subjects similar at baseline?

No treatment and control subjects employed in the study however, the demographics of the participants were clearly stated in the research.

Were data presented in a clear and understandable format? Were data for both efficacy and safety of the treatment clearly reported?
Yes
The data were illustrated in tables with appropriate titles and labels. Legends were also presented below the tables for easy comprehension of the data demonstrated. No data was indicated regarding the efficacy and safety of treatment because the study is just descriptive which aims to examine the association between childhood eczema and asthma incidence from preadolescence to middle age, and between childhood eczema and asthma persisting to middle age.

Was an intent-to-treat analysis conducted?

Were exact p-values or confidence intervals reported?

Yes
The study results presented exact p-values in which the analyses were performed using Stata statistical software version 9.1. In the research, a 2-sided p-value of < 0.05 was taken to indicate statistical significance for all estimates.

Was study power calculated?

Could a type I or type II error have occurred?

Were study results valid?

Can study results be generalized to patients in clinical practice?

No The participants in this study were only Australians in which their genetic make-up and characteristics differ from that of the other races and may be a factor for not having generalized results. The results of this study are applicable for the patients of the same race however, for other races, various factors must be taken into consideration.

Were the results both statistically and clinically significant?

Conclusions/ Discussion

Did the authors compare their study results to those of a systematic review of all previously published data?

Were study conclusions consistent with the results and did they relate to the study conclusion?
Yes
The correlation between childhood eczema and childhood asthma which was presented in the conclusion is just the same with that of the results; though in the results part, the correlation was presented statistically.

Did the study results support the conclusion?

Yes
The results obtained statistically were able to support the stated conclusion. The information presented in the results section was just the statistical explanation of what were being illustrated in the conclusion of the study.

References

Is current literature well represented?