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EEG for children with complex febrile seizures

  1. Pankaj B Shah1,*,
  2. Saji James2,
  3. S Elayaraja2

Editorial Group: Cochrane Epilepsy Group

Published Online: 24 JAN 2014

Assessed as up-to-date: 17 OCT 2013

DOI: 10.1002/14651858.CD009196.pub2


How to Cite

Shah PB, James S, Elayaraja S. EEG for children with complex febrile seizures. Cochrane Database of Systematic Reviews 2014, Issue 1. Art. No.: CD009196. DOI: 10.1002/14651858.CD009196.pub2.

Author Information

  1. 1

    Sri Ramachandra Medical College and Research Institute, Sri. Ramachandra University, Department of Community Medicine, Chennai, Tamil Nadu, India

  2. 2

    Sri Ramachandra Medical College and Research Institute, Sri. Ramachandra University, Department of Paediatric Medicine, Chennai, Tamil Nadu, India

*Pankaj B Shah, Department of Community Medicine, Sri Ramachandra Medical College and Research Institute, Sri. Ramachandra University, Ramachandra Nagar, Porur, Chennai, Tamil Nadu, 600116, India. drpankajsshah@yahoo.co.in.

Publication History

  1. Publication Status: New
  2. Published Online: 24 JAN 2014

SEARCH

 

Background

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. Contributions of authors
  12. Declarations of interest
  13. Sources of support
  14. Differences between protocol and review
  15. Index terms
 

Description of the condition

According to the National Institutes of Health (NIH) and the International League Against Epilepsy (ILAE), febrile seizures can occur between the ages of one month and five years (Freeman 1980; ILAE 1993) and are associated with fever with no intracranial infection or defined cause (Freeman 1980). Febrile seizures can be classified as simple or complex. Simple febrile seizures are generalised tonic or tonic-clonic convulsions lasting less than 15 minutes that occur only once in a 24-hour period in a neurologically and developmentally normal child. If focal features are present, the seizures last longer than 15 minutes, the child has a pre-existing neurological condition and the seizures occur multiple times (recurrent within 24 hours) or within the same febrile event, the febrile seizures are referred to as complex (Francis 2006; Kevin 2001; Kliegman 1996; Waruiru 2004). The incidence of febrile seizures varies from 2% to 5% in Western Europe and the United States (Joshi 2005; Waruiru 2004) and from 5% to 10% in India and is reported at 8.8% in Japan and 14% in Guam (Waruiru 2004). Data from the developing world are limited (Waruiru 2004).

A child with febrile seizures usually does not need to be hospitalised. However, when the seizure is prolonged or is accompanied by a serious infection, or when the source of the infection cannot be determined, hospitalisation for observation may be recommended. Prolonged daily use of oral antiepileptic drugs to prevent febrile seizures usually is not recommended because of their potential for side effects and their questionable effectiveness in preventing such seizures (Kliegman 1996; Offringa 2012)

 

Description of the intervention

An electroencephalograph (EEG) records brain waves detected by electrodes placed on the scalp. Reporting of paroxysmal EEG abnormalities in children with febrile seizures may vary widely (Panayiotopoulos CP 2005). The reasons may be related to differences in participant selection by different authors, the criteria used in different studies to define paroxysmal discharges or the timing of the EEG.

The American Academy of Pediatrics practice parameter on febrile seizures recommends that an EEG should not be part of a routine investigation after a simple febrile seizure in neurologically normal children because of its lack of usefulness in predicting recurrence risk or future epilepsy (American Academy of Pediatrics 1996; Joshi 2005; Kuturec 1997). The quality standards subcommittees of the American Academy of Neurology, the Child Neurology Society and the American Epilepsy Society recommend an EEG in the initial evaluation of the first afebrile seizure, as an abnormal EEG predicts recurrence (Hirtz 2000; Joshi 2005). The precise role of EEG in the evaluation of patients with complex febrile seizure (CFS) has not been established; however, it is common for both paediatricians and specialists to recommend EEGs on these patients (Joshi 2005; Millichap 1991) in some countries. An EEG taken within the first week after a febrile seizure is termed an 'early EEG', whereas an EEG taken anytime between the first week and one month after the seizure activity is termed a 'late EEG'. Few retrospective studies have tried to assess the use of EEGs in complex febrile seizure (Maytal 2000; Yucel 2004).

 

How the intervention might work

An EEG performed in the evaluation of complex febrile seizures may help identify the nature of the underlying acute or remote cerebral pathology and predict the risk of future seizures.

 

Why it is important to do this review

Much uncertainty remains about the use of an EEG and its timing in children with complex febrile seizures, hence it is necessary to carry out this review.

 

Objectives

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. Contributions of authors
  12. Declarations of interest
  13. Sources of support
  14. Differences between protocol and review
  15. Index terms

To assess the use of EEG and its timing after complex febrile seizures in children younger than five years of age.

 

Methods

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. Contributions of authors
  12. Declarations of interest
  13. Sources of support
  14. Differences between protocol and review
  15. Index terms
 

Criteria for considering studies for this review

 

Types of studies

We planned to include parallel-group randomised controlled trials (RCTs).

 

Types of participants

Participants in the studies eligible for inclusion were children of either sex younger than five years of age with first episode of complex febrile seizure.

Participants would be included in the review only:

  • if the EEG was performed after the first complex febrile seizure episode; or
  • if recruitment of participants into the study was delayed and the EEG was performed before the participant's second seizure.

We excluded studies in which participants had other neurological disorders (e.g. behavioral disorders, cerebral palsy, mental retardation).

 

Types of interventions

The intervention is EEG investigation (i.e. electroencephalography). Two comparisons are made.

  • Participants without administration of an EEG versus participants with administration of an EEG (early or late or at any time).
  • Participants with administration of an early EEG versus participants with administration of a late EEG.

 

Types of outcome measures

 

Primary outcomes

  • Proportions of participants developing seizures of any type after follow-up periods of one month, six months, twelve months and two years in two comparison groups of EEG versus no EEG and early EEG versus late EEG.

We decided to include any type of seizure in the outcome. We recorded the available outcome measures with respect to a particular time period. We planned additionally to contact the original trial authors to enquire whether outcome measurements had been recorded for other time periods of interest. We believe that the most important clinically relevant time period was two years.

  • Risk of recurrence between no EEG and EEG (early EEG, late EEG or any other time), which will act as a surrogate outcome.
  • Total number of seizure episodes in each group during the two-year follow-up.
  • Time to development of seizures as time to event outcome.
  • Adverse events (although the EEG may not cause any adverse event per se, adverse events may be related to sedation given to participants and may be transient).

 

Search methods for identification of studies

 

Electronic searches

We searched the following databases (Appendix 1).

  • The Cochrane Epilepsy Group Specialised Register (17 October 2013).
  • The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 9, 2013).
  • MEDLINE (17 October 2013).
  • Clinical Trial Registry (ClinicalTrials.gov (17 October 2013).

 

Searching other resources

We searched the references of all studies retrieved in full to identify additional research papers. We contacted authors of relevant articles and experts in the field to ask about additional research papers and unpublished trials. We looked for conference proceedings for trials relevant to our review. We decided not to impose language restrictions.

 

Data collection and analysis

 

Selection of studies

Dr Pankaj B. Shah (methodology expert (PBS)) and Dr Saji James (content expert (SJ)) carried out the searches (Lefebvre 2009). The methodology expert and the content expert independently carried out an initial screening of the titles of research papers. If papers were believed to be relevant, the review authors independently screened the abstracts. For all articles whose abstracts were found to be relevant, we retrieved the full text. When full-text articles were not available, we contacted the study authors and asked them to provide the full text of the article. We decided to also use the above mentioned search methodology during screening of the cross-references of the full-text retrieved articles and articles suggested by authors and experts in the field. PBS and SJ reviewed the full-text articles independently. After reviewing the research papers, we classified each into one of the following groups.

  • Included studies.
  • Excluded studies.
  • Studies pending decision (if required, authors were contacted to provide additional details of the study).

We recorded the information collected during the above review process on the eligibility assessment form included in Appendix 2.

We attempted to identify duplicate publications by assessing similar study types, same place or same authors (maybe with different sequence). We used reference management software (Mozilla with Zotero) to identify and exclude duplicate publications. In cases of doubt, we contacted the study authors to avoid inclusion of duplicate publications in this review.

We agreed to resolve any disagreements by discussion and to reach a final decision by consensus or by consultation with the Cochrane Epilepsy Group. We used standard methodological procedures expected by The Cochrane Collaboration.

 

Data extraction and management

We could not extract the data in the present review, as no study met the inclusion criteria. The data extraction process was decided as follows.

  • PBS and SJ decided to independently extract required data from the full-text articles of the included studies. (We have included the data extraction form in Appendix 3.) The data extraction form had five components.

    • Identification of study.
    • Characteristics of included studies—with a brief description in tabular form of methods, participants, interventions and outcomes and notes on specific issues (if any).
    • Risk of bias table, as per Cochrane Guidelines (Altman 2008).
    • Measurements of treatment effects extracted.
    • Information pertaining to any discrepancy noted in records of the clinical trial registry.

  • We agreed to resolve any disagreements by discussion and to reach a final decision by consensus or by consultation with the Cochrane Epilepsy Group. We agreed to follow guidelines of a quality of reporting meta-analysis, or QUOROM statement, and PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses, (formerly QUOROM) (Moher 2009).

 

Assessment of risk of bias in included studies

We could not assess the risk of bias in the present review, as no study met the inclusion criteria.

We wanted to report the following bias as recommended in the guidelines for risk of bias tables (Altman 2008; Appendix 4). We agreed to fill the description for each domain with the quote from the article or correspondence and then comment with judgement regarding particular bias (yes, no or unclear); we decided to undertake a summary assessment of risk of bias for each outcome (across domains) within and across studies and to make judgements about the risk of bias as low, unclear or high. We planned to report a risk of bias graph and a risk of bias summary figure. PBS and SJ decided to independently assess the risk of bias. We agreed to resolve any disagreements by discussion and to reach a final decision by consensus or by consultation with the Cochrane Epilepsy Group.

Characteristics of excluded studies: We provided a list of excluded studies with reasons for exclusion in tabular form.

Characteristics of ongoing studies: We could not report in tabular form the details of any ongoing studies in terms of methods, interventions and outcomes or trial registration numbers.

 

Measures of treatment effect

We could not measure the treatment effect in the present review, as no study met the inclusion criteria. The process of measurement of treatment effect was decided as follows.

We planned to calculate proportions of participants developing seizure after follow-up periods of one month, six months, 12 months and two years. We also planned to calculate risk of recurrence between no EEG and EEG (early EEG, late EEG or any other time), total number of seizure episodes in each group during the two-year follow-up, time to development of seizures as time to event outcome and adverse events (if any). We agreed to use odds ratio for dichotomous outcomes and mean difference for continuous data. We decided to convert extracted data to the above measures for treatment effects, if they were given in other forms. We would extract or calculate 95% confidence intervals for all data. In the case of insufficient information, we would contact study authors to ask for additional details.

 

Unit of analysis issues

We did not anticipate any unit of analysis issues.

 

Dealing with missing data

We contacted study authors to ask for missing data such as method of randomisation not stated in the paper or whether the outcome of interest was not reported but has been analysed. The reasons for missing data if found would have helped us with imputation of missing data.

 

Assessment of heterogeneity

We could not assess the heterogeneity in the present review, as no study met the inclusion criteria. The process of assessment of heterogeneity was decided as follows.

We decided to assess clinical heterogeneity by comparing participant factors, interventional factors, outcome factors and methodological heterogeneity by study methods. We also planned to assess statistical heterogeneity by measuring variability in interventional effects by visually comparing the overlap of confidence intervals on forest plots. If confidence intervals for the results of individual studies had poor overlap, this might have indicated the presence of statistical heterogeneity. We also planned to measure statistical heterogeneity by using the I2 statistic and interpreting it as follows (Deeks 2008).

  • 0% to 40%: might not be important.
  • 30% to 60%: may represent moderate heterogeneity.
  • 50% to 90%: may represent substantial heterogeneity.
  • 75% to 100%: might represent considerable heterogeneity.

 

Assessment of reporting biases

During this stage, the review authors were to try to find out primary and secondary outcomes of the included studies from the clinical trial registry (if possible) to assess any discrepancy in reporting. If we found any, we were to report them. We agreed to assess funnel plot asymmetry if we identified more than 10 studies. Reasons for asymmetry include publication bias, outcome reporting bias and heterogeneity.

 

Data synthesis

We could not attempt data synthesis in the present review, as no study met the inclusion criteria. The process of data synthesis was decided as follows.

We planned to analyse each trial and record data on the data extraction form. Review authors decided to enter the results of each study independently using The Cochrane Collaboration's Review Manager software (RevMan 2008). We planned to carry out a meta-analysis according to Cochrane guidelines; the most common method available using RevMan is the Mantel-Haenszel (MH) method. If RCTs were clustered, we would have used the inverse method (IV). In case of heterogeneity, we planned to carry out a thorough assessment (Assessment of heterogeneity).

 

Subgroup analysis and investigation of heterogeneity

We could not attempt the above in the present review, as no study met the inclusion criteria. The process agreed upon was as follows.

We planned to carry out subgroup analyses on the basis of sex, duration of disease, duration of hospitalisation and length of follow-up period. In cases of significant heterogeneity, we might have followed the steps outlined below.

  • Recheck extraction and recording of data.
  • Change from random-effects model to fixed-effect model.
  • Perform sensitivity analysis (Sensitivity analysis).
  • Explore heterogeneity by subgroup analysis.
  • Present systematic review without meta-analysis.

 

Sensitivity analysis

Sensitivity analysis is a repeat primary analysis in which alternative decisions and ranges of values are substituted for decision making related to assessment of the robustness of conclusions.

We could not attempt sensitivity analysis in the present review, as no study met the inclusion criteria.

We planned to carry out the following steps in a sensitivity analysis.

  • Some studies have larger effects than others because
    • Random error means that multiple replications of the same study will produce different effect estimates because of sampling variation, even if replications would yield the right answer on average. The results of smaller studies are subject to greater sampling variation and hence are less precise. Imprecision is reflected in the confidence interval around the intervention effect estimate from each study and in the weight given to the results of each study in a meta-analysis. More precise results are given more weight.
  • In cases of missing values, use of following imputation methods are suggested.
    • Many methods for imputation techniques have been proposed. In cases of dichotomous data, best case-worst case analysis is done, so it is possible to find out how the risk factor or the result value may vary in different situations. For continuous data, the last value takes the role of the missing value. These imputations are important because RCTs have to be analysed as intention-to-treat analyses.
  • Use the random-effects instead of the fixed-effect model.

The above sensitivity analyses were prespecified, but it was not possible to specify all sensitivity analyses, as many potential issues might develop only in the course of completing the review. In case sensitivity analysis had an influence on the robustness of the conclusion, we decided to attempt to resolve the uncertainty by contacting trial authors and consulting the Cochrane Epilepsy Group. As it might not be possible to report all sensitivity analyses in detail, we planned to provide a summary table. Sensitivity analysis would have helped us to explore the influence of various factors.

 

Summary of findings tables

We were to provide Summary of findings tables, prepared with the help of GRADEPro software. We planned to report a rating of overall quality of evidence for each outcome, as well as conclusions, and implications for practice and research (Appendix 5). PBS and SJ agreed to prepare independently the summary of findings. We agreed to resolve any disagreements by discussion and to reach final decisions by consensus or by consultation with the Cochrane Epilepsy Group.

We conducted the review according to the recommendations of the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2008).

 

Results

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. Contributions of authors
  12. Declarations of interest
  13. Sources of support
  14. Differences between protocol and review
  15. Index terms
 

Description of studies

 

Results of the search

With the help of the Trials Search Co-ordinator of the Cochrane Epilepsy Group, 33 potentially eligible studies were identified for this review on 17 October 2013. The summary of the results of the search is included in Appendix 6. After assessing the titles and abstracts, the review authors found no studies for possible inclusion in the review.

 

Included studies

None of the studies met the inclusion criteria; thus we did not include any study in the present review.

 

Excluded studies

All studies were excluded because the study design and the intervention were not of interest for this review (Excluded studies).

 

Risk of bias in included studies

No studies were included in this review, hence the risk of bias is not applicable.

 

Effects of interventions

In the absence of any suitable studies for this review, analyses were not possible. Although we could not attempt the data collection and analysis as it was decided in the protocol, we decided to describe the process of different aspects of data collection and analysis, as the review will be updated regularly and the full protocol may not be easily accessible to all users of this evidence.

We could provide no summary of findings table in the present review, as no study met the inclusion criteria.

 

Discussion

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. Contributions of authors
  12. Declarations of interest
  13. Sources of support
  14. Differences between protocol and review
  15. Index terms
 

Summary of main results

We did not find any randomised controlled trials of EEG for children with complex febrile seizures. Hence currently no randomised high-quality evidence can be reported for an EEG and its timing after complex febrile seizures in children younger than five years of age.

 

Overall completeness and applicability of evidence

A comprehensive search of the literature was done as described in Appendix 6, and a number of studies that may be relevant to the review were assessed. No randomised controlled trials were identified.

 

Quality of the evidence

It is very difficult to comment on the quality of evidence, as none of the studies met the inclusion criteria.

 

Potential biases in the review process

None.

 

Agreements and disagreements with other studies or reviews

No other similar review has been conducted. However, a few published non-randomised studies to date have looked specifically at CFS and the role of EEG in its evaluation (Joshi 2005; Maytal 2000; Yucel 2004). In a retrospective review of 33 neurologically normal participants with EEGs within one week of CFS, Maytal et al found none with abnormalities, but Yucel et al reported abnormalities in 71 of 159 children with CFS analysed retrospectively over seven years. In the latter group, 16 were noted to have abnormal EEG records in the first week. Of 71 participants with abnormal EEG records, 51 were diagnosed with epilepsy on follow-up. One other study by Joshi et al showed that children with CFS are approximately 3.5 times more likely to display an abnormal EEG within seven days post ictus in comparison with children with CFS in whom the EEG was performed beyond the seven-day period post ictus. Hence, conflicting reports describe the utility of EEG and its timing after complex febrile seizures among children.

 

Authors' conclusions

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. Contributions of authors
  12. Declarations of interest
  13. Sources of support
  14. Differences between protocol and review
  15. Index terms

 

Implications for practice

Although it is common for both paediatricians and specialists, in some countries, to recommend EEGs for children with complex febrile seizures (Joshi 2005; Millichap 1991), evidence to support or refute the use of EEG and its timing after complex febrile seizures among children is lacking.

 
Implications for research

This review has highlighted the absence of randomised controlled trials investigating the utility of EEG and its timing after complex febrile seizures in children. We found no RCT as evidence to support or refute the utility of EEG and its timing after complex febrile seizures among children. A randomised controlled trial can be planned in such a way that participants are randomly assigned to an EEG group and a non-EEG group with sufficient sample size. Hence well-designed randomised controlled trials are required to confirm the same. These clinical trials should follow good clinical practice (GCP) guidelines with important stress on methodological issues such as randomisation, blinding of outcome assessment, intention-to-treat analysis and scientific means to reduce the bias.

Updating the review: In accordance with Cochrane policy, we plan to update the review every two years (or sooner, should we find any important study that fulfils the inclusion criteria).

 

Acknowledgements

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. Contributions of authors
  12. Declarations of interest
  13. Sources of support
  14. Differences between protocol and review
  15. Index terms

We would like to thank the following.

  • The Cochrane Epilepsy Group for valuable guidance provided.
  • The Indian Council of Medical Research and the South Asian Cochrane Network and Centre, Prof BV Moses and the ICMR Centre for Advanced Research and Training in Evidence-Based Healthcare and CMC Vellore for supporting the training program and makingThe Cochrane Library free for India.
  • Prof Prathap Tharyan, Director, South Asian Cochrane Network and Centre, Prof BV Moses and the ICMR Centre for Advanced Research and Training in Evidence-Based Healthcare and CMC Vellore for guidance provided during the training workshop.
  • Management, Vice Chancellor, Deans, HOD and Faculty members of our departments of SRU for continuous inspiration and support.
  • Family members for continuous inspiration and support.

 

Data and analyses

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. Contributions of authors
  12. Declarations of interest
  13. Sources of support
  14. Differences between protocol and review
  15. Index terms

This review has no analyses.

 

Appendices

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. Contributions of authors
  12. Declarations of interest
  13. Sources of support
  14. Differences between protocol and review
  15. Index terms
 

Appendix 1. Search strategy

 

EEG for children with complex febrile seizures

1 Epilepsy Specialised Register 17 October 2013

#1 MeSH DESCRIPTOR Seizures, Febrile Explode All WITH BL CF CI CL CO CN DI DH DT EC EM EN EP EH ET GE HI IM ME MI MO NU PS PA PP PC PX RA RI RT RH SU TH US UR VE VI

#2 (febrile seizure*) or (febrile convulsion*) or (pyrexial seizure*) or (pyrexial convulsion*) or (fever seizure*) or (fever convulsion*)

#3 #1 OR #2

#4 MeSH DESCRIPTOR Electroencephalography Explode All WITH AE CL CT DE EC ES HI IS MT MO NU PX RE ST SN TD UT VE

#5 electroencephalograph* or EEG

#6 #4 OR #5

#7 #3 AND #6

#8 #3 AND #6 AND INREGISTER AND >2011:YR

2 CENTRAL, Issue 9, The Cochrane Library, September 2013

#1 MeSH descriptor: [Seizures, Febrile] explode all trees

#2 (febrile seizure*) or (febrile convulsion*) or (pyrexial seizure*) or (pyrexial convulsion*) or (fever seizure*) or (fever convulsion*)

#3 #1 or #2

#4 MeSH descriptor: [Electroencephalography] explode all trees

#5 electroencephalograph* or EEG

#6 #4 or #5

#7 #3 and #6 from 2012, in Trials

3 MEDLINE (Ovid) 1946 to 17 October 2013

1. (randomized controlled trial or controlled clinical trial).pt. or (randomized or placebo or randomly).ab.

2. clinical trials as topic.sh.

3. trial.ti.

4. 1 or 2 or 3

5. exp animals/ not humans.sh.

6. 4 not 5

7. exp Seizures, Febrile/

8. febrile seizure*.tw.

9. febrile convulsion*.tw.

10. pyrexial seizure*.tw.

11. pyrexial convulsion*.tw.

12. fever seizure*.tw.

13. fever convulsion*.tw.

14. 7 or 8 or 9 or 10 or 11 or 12 or 13

15. exp Electroencephalography/

16. (electroencephalograph* or EEG).tw.

17. 15 or 16

18. 6 and 14 and 17

19. limit 18 to ed=20121001-20131017

 

Appendix 2. Eligibility assessment form

Name of the review author:                                                 Date:

 

Title of the study:                                                                   Study ID:

 

Name of the authors of the study:

 

Name of the journal with year of publication:

 

 

Questions:

 


No.Questions Remark

   

1.       Is the study a randomised clinical trial or a quasi-experimental study?    

 
Yes      No    Unclear

2Did participants in the study have complex febrile seizures with first episode?Yes      No    Unclear

3Is a comparison made of no EEG and EEG (early EEG, late EEG or any time) among children having complex febrile seizures with first episode?Yes      No    Unclear

4Did the study report better epileptic management or assess risk of occurrence? Yes      No    Unclear



 

Final decision:  Include                      Exclude                       Unclear              Pending

Note:

1.      Reasons for excluding the study:

2.      In case study is labelled as “unclear”- Contact the authors __________ date:

3.      In case study is labelled as “pending”- Contact the authors ___________date:

4.      Response of the author: ___________________   date:

5.      Opinion of Cochrane Epilepsy Group sought:___________________ date:

6.      Opinion of Cochrane Epilepsy Group: _________________________ date:

Final decision:

 

Appendix 3. Data extraction form


Date 


Name of the review author 


Title of included study 


Authors  


Journal  


Year of publication 


Sponsor of the study 


Conflict of Interest


Participants

Inclusion criteria 


Exclusion criteria 


Age range 


Ethnicity 


Any other comorbid condition 


Notes 


Intervention

No EEG and EEG (early, late EEG or any other time)(with exact details of days of seizure attack) 


Notes 


  


Outcome for no EEG or EEG (early EEG, late EEG or any other time)

                                                     No EEG   EEG (early, late or any other time)

List of outcomes  

  

Notes  

Brief description of methodology

  


  


  


  


  


  


  


  


  


  


Risk of bias tool

  


Sequence generationQuote:

 

Comment:

 

Judgement :   Yes              No                 Unclear

 


Allocation concealment Quote:

 

Comment:

 

Judgement :   Yes              No                 Unclear

 


Blinding of participants, personnel and outcome

assessors
Quote:

 

Comment:

 

Judgement :   Yes              No                 Unclear

 


Incomplete outcome dataQuote:

 

Comment:

 

Judgement :   Yes              No                 Unclear

 


Selective outcome

reporting
Quote:

 

Comment:

 

Judgement :   Yes              No                 Unclear

 


Free of other biases Quote:

 

Comment:

 

Judgement :   Yes              No                 Unclear

 


Clinical trial registration details Registration no.:

Website link:     

Access date:

Primary outcome:

Secondary outcome:

Any discrepancy with respect to outcome (compare with report):

Any other discrepancy:

 



 

 

Note:

1.      Response of the author sought: ___________________   date:                  

2.      Response of the author: ___________________  date: _________________________

3.      Opinion of Cochrane Epilepsy Group sought:___________________ date:______________

4.      Opinion of Cochrane Epilepsy Group: _________________________ date:___________________

Final comments:

 

Appendix 4. Risk of bias tool

 


No.Name of the biasDescriptionDomains in the “risk of bias” table

1Selection biasSystematic differences between baseline characteristics of the groups that are compared
  • Sequence generation


  • Allocation concealment

2Performance biasSystematic differences between groups in the care that is provided, or in exposure to factors other than the interventions of interestBlinding of participant,

personnel and outcome

assessors

 

3Attrition biasSystematic differences between groups in withdrawals from study
  • Incomplete outcome data


  • Blinding

4Detection biasSystematic differences between groups in how outcomes are determinedBlinding of participants,

personnel and outcome

assessors

 

5Reporting biasSystematic differences between reported and unreported findingsSelective outcome

reporting



 

 

Appendix 5. Summary of findings table

The GRADE approach describes levels of quality of a body of evidence as follows.


No.Underlying methodology qualityRating

1Randomised trials or double-upgraded observational studiesHigh

2Downgraded randomised trials or upgraded observational studiesModerate

3Double-downgraded randomised trials or observational studiesLow

4Triple-downgraded randomised trials, downgraded observational
studies or case series/case reports
Very low



 

Factors that would have reduced the quality of the evidence include the following.


No.FactorConsequence

1Limitations in study design or execution (risk of

bias)

 
One or two levels

 

2Inconsistency of resultsOne or two levels

3Indirectness of evidenceOne or two levels

4ImprecisionOne or two levels

5Publication biasOne or two levels



Factors that would have increased the quality of the evidence include the following.


NoFactorConsequence

1Large magnitude of effect

 
One or two levels

2Dose-response gradient

 
One level

 



For example, if we would have found that the results were precise, we would have chosen 'no' in GRADEPro software. If serious imprecision was present, we would have chosen four and downgraded by one level in the GRADEPro software. If very serious imprecision was present, we would have chosen 'very serious', and this might have led to downgrading of the quality of evidence for the particular outcome by two levels. A footnote in the summary of findings table would have documented this.

 

Appendix 6. Summary of the results of the search

The following table describes the summary of the results of the search for the review.


DatabaseDate searched Number of ‘hits’*Total no. of hits after duplicates removed*Total no. of hits after irrelevant reports removed*

Cochrane Epilepsy Group Specialised Register18 October 2012 and 17 October 20137 (2012) and 0 (2013)25

 

 
0

CENTRAL, Issue 9, The Cochrane Library, September 201318 October 2012 and 17 October 201313 (2012) and 0 (2013)

MEDLINE (Ovid)

1946 to 17 October 2013
18 October 2012 and 17 October 201321 (2012) and 0 (2013)

ClinicalTrials.gov18 October 2012 and 17 October 20133 (2012) and 5 (2013)8



 

 

Contributions of authors

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. Contributions of authors
  12. Declarations of interest
  13. Sources of support
  14. Differences between protocol and review
  15. Index terms

Develop search strategy: PBS, SJ with Trials Search Co-ordinator.
Search for trials: PBS, SJ with Trials Search Co-ordinator.
Obtain copies of trials: PBS, SJ and SE with Trials Search Co-ordinator.
Select trials to include: PBS, SJ and SE.
Draft the final review: PBS, SJ and SE.

 

Declarations of interest

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. Contributions of authors
  12. Declarations of interest
  13. Sources of support
  14. Differences between protocol and review
  15. Index terms

None known.

 

Sources of support

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. Contributions of authors
  12. Declarations of interest
  13. Sources of support
  14. Differences between protocol and review
  15. Index terms
 

Internal sources

  • None, Not specified.

 

External sources

  • None, Not specified.

 

Differences between protocol and review

  1. Top of page
  2. Background
  3. Objectives
  4. Methods
  5. Results
  6. Discussion
  7. Authors' conclusions
  8. Acknowledgements
  9. Data and analyses
  10. Appendices
  11. Contributions of authors
  12. Declarations of interest
  13. Sources of support
  14. Differences between protocol and review
  15. Index terms

We could not attempt the data collection analysis and summary of findings table, as no study met the inclusion criteria. We decided to describe the process of different aspects of data collection and analysis in the present review, as the review will be updated regularly and the full protocol may not be easily accessible to all users of this evidence.

References

References to studies excluded from this review

  1. Top of page
  2. AbstractRésumé
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Contributions of authors
  13. Declarations of interest
  14. Sources of support
  15. Differences between protocol and review
  16. Characteristics of studies
  17. References to studies excluded from this review
  18. Additional references
  19. References to other published versions of this review
Aksu 2011 {published data only}
Berg 2008 {published data only}
Bernasconi 1998 {published data only}
  • Bernasconi A, Andermann F, Cendes F, Dubeau F, Andermann E, Olivier A. Nocturnal temporal lobe epilepsy. Neurology 1998;50(6):1772-7.
Burneo 2005 {published data only}
Drayer 1982 {published data only}
  • Drayer B, Suslavich F, Luther J, Rommel A, Allen S, Dubois P, et al. Clinical trial of iopamidol for lumbosacral myelography. Electroencephalography 1982;3(1):59-64.
Fallah 2007 {published data only}
  • Fallah R, Gofrani M. Comparison of intravenous lidocaine and midazolam infusion for refractory convulsive status epilepticus in children. Journal of Pediatric Neurology 2007;5(4):287-90.
Grigsby 1998 {published data only}
Heijbel 1980 {published data only}
Huang 2007 {published data only}
  • HuangY, Yang L, Wang S, Wang G. Alterative application of five anticonvulsants according to the half life for the treatment of status epilepticus in children with severe viral encephalitis. Neural Regeneration Research 2007;2(9):561-4.
Kaminska 1999 {published data only}
  • Kaminska A, Ickowicz A, Plouin P, Bru MF, Dellatolas G, Dulac O. Delineation of cryptogenic Lennox-Gastaut syndrome and myoclonic astatic epilepsy using multiple correspondence analysis. Epilepsy Research 1999;36(1):15-29.
Knudsen 1985 {published data only}
Mackintosh 1970 {published data only}
  • Mackintosh TF. Studies on prophylactic treatment of febrile convulsions in children. Is it feasible to inhibit attacks by giving drugs at the first sign of fever or infection?. Clinical Pediatrics 1970;9(5):283-6.
Mahmoudian 2004 {published data only}
Mamelle 1982 {published data only}
  • Mamelle JC, Mamelle N, Plasse JC, Revol M, Gilly R. The efficacy of sodium valproate compared with that of phenobarbitone and placebo in the prophylaxis of febrile convulsions. Pediatrics 1982;37(6):433-45.
Mamelle 1984 {published data only}
  • Mamelle N, Mamelle JC, Plasse JC, Revol M, Gilly R. Prevention of recurrent febrile convulsions: a randomized therapeutic assay: sodium valproate, phenobarbital and placebo. Neuropediatrics 1984;15(1):37-42.
Natriashvili 2005 {published data only}
  • Natriashvili G, Natriashvili S, Kapanadze N. Mexidol in treatment of children with generalized epilepsy and febrile seizures. Georgian Medical News 2005;122:40-4.
NCT01370044 {published data only}
  • NCT01370044. Carbon Dioxide (Carbogen) for the Treatment of Febrile Seizures (CARDIF). http://clinicaltrials.gov/show/NCT01370044 (accessed 17 October 2013).
NCT01694524 {published data only}
  • NCT01694524. Nervous System Infections Among Patients With Febrile Seizure. http://clinicaltrials.gov/show/NCT01694524 (accessed 17 October 2013).
NCT01738841 {published data only}
  • NCT01738841. Safety Study of Measles-Mumps-Rubella-Varicella (MMRV) Vaccine, Priorix-Tetra™ in Children Living in the Philippines. http://ClinicalTrials.gov/show/NCT01738841 (accessed 17 October 2013).
NCT01884766 {published data only}
  • NCT01884766. Copeptin in Childhood Epilepsy. http://ClinicalTrials.gov/show/NCT01884766 (accessed 17 October 2013).
NCT01906619 {published data only}
  • NCT01906619. Respiratory Physiology in Children With Febrile Seizures. http://clinicaltrials.gov/show/NCT01906619 (accessed 17 October 2013).
NCT01931813 {published data only}
  • NCT01931813. METHORIVAC - Vaccinal Pharmacoepidemiologic. http://ClinicalTrials.gov/show/NCT01931813 (accessed 17 October 2013).
NCT01946594 {published data only}
  • NCT01946594. Clinical Immunization Safety Assessment (CISA) Project: Pilot Study to Assess the Effect of Prophylactic Antipyretics on Immune Responses and Fever After IIV. http://ClinicalTrials.gov/show/NCT01946594 (accessed 17 October 2013).
Novotny 2010 {published data only}
  • Novotny E, Renfroe B, Yardi N, Nordli D, Ness S, Wang S, et al. Randomized trial of adjunctive topiramate therapy in infants with refractory partial seizures. Neurology 2010;74(9):714-20.
O'Brien 2008 {published data only}
  • O'Brien TJ, Mosewich RK, Britton JW, Cascino GD, So EL. History and seizure semiology in distinguishing frontal lobe seizures and temporal lobe seizures. Epilepsy Research 2008;82(2-3):177-82.
Pavlidou 2006 {published data only}
  • Pavlidou E, Tzitiridou M, Panteliadis C. Effectiveness of intermittent diazepam prophylaxis in febrile seizures: long-term prospective controlled study. Journal of Child Neurology 2006;21(12):1036-40.
Pina-Garza 2005 {published data only}
  • Pina-Garza JE, Espinoza R, Nordli D, Bennett DA, Spirito S, Stites TE, et al. Oxcarbazepine adjunctive therapy in infants and young children with partial seizures. Neurology 2005;65(9):1370-5.
Reijs 2007 {published data only}
  • Reijs RP, van Mil SG, Arends JB, van HMH, Weber JW, Renier WO, et al. Cryptogenic localization related epilepsy in children from a tertiary outpatient clinic: is neurological and neuropsychological outcome predictable?. Clinical Neurology and Neurosurgery 2007;109(5):422-30.
Rosati 2003 {published data only}
  • Rosati A, Aghakhani Y, Bernasconi A, Olivier A, Andermann F, Gotman J, et al. Intractable temporal lobe epilepsy with rare spikes is less severe than with frequent spikes. Neurology 2003;60(8):1290-5.
Rose 2005 {published data only}
  • Rose W, Kirubakaran C, Scott JX. Intermittent clobazam therapy in febrile seizures. Indian Journal of Pediatrics 2005;72(1):31-3.
Rosman 1987 {published data only}
  • Rosman NP. Febrile seizures. Emergency Medicine Clinics of North America 1987;5(4):719-37.
Strengell T 2009 {published data only}
  • Strengell T,  Uhari M,  Tarkka R,  Uusimaa J,  Alen R,  Lautala P, et al. Antipyretic agents for preventing recurrences of febrile seizures: randomized controlled trial. Archives of Pediatrics and Adolescent Medicine 2009;163(9):799-804.
Tsuboi 1988 {published data only}

Additional references

  1. Top of page
  2. AbstractRésumé
  3. Background
  4. Objectives
  5. Methods
  6. Results
  7. Discussion
  8. Authors' conclusions
  9. Acknowledgements
  10. Data and analyses
  11. Appendices
  12. Contributions of authors
  13. Declarations of interest
  14. Sources of support
  15. Differences between protocol and review
  16. Characteristics of studies
  17. References to studies excluded from this review
  18. Additional references
  19. References to other published versions of this review
Altman 2008
  • Higgins JPT, Altman DG. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated September 2008]. The Cochrane Collaboration, 2008. www.cochrane-handbook.org.
American Academy of Pediatrics 1996
  • American Academy of Pediatrics. Practice parameter: the neurodiagnostic evaluation of the child with a first simple febrile seizure. American Academy of Pediatrics. Provisional Committee on Quality Improvement, Subcommittee on Febrile Seizures. Pediatrics 1996;97:769-72.
Deeks 2008
  • Deeks JJ, Higgins JPT, Altman DG. Chapter 9: Analysing data and undertaking meta-analyses. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.1 [updated September 2008]. The Cochrane Collaboration, 2008. www.cochrane-handbook.org.
Francis 2006
  • Francis J, DiMario MD Jr. Children presenting with complex febrile seizures do not routinely need computed tomography scanning in the emergency department. Pediatrics 2006;117(2):528-30.
Freeman 1980
Higgins 2008
  • Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.2 [updated September 2009]. The Cochrane Collaboration, 2009. www.cochrane-handbook.org.
Hirtz 2000
  • Hirtz D, Ashwal S, Berg A, Bettis D, Camfield C, Camfield P, et al. Practice parameter: evaluating a first nonfebrile seizure in children: report of the quality standards subcommittee of the American Academy of Neurology, The Child Neurology Society, and The American Epilepsy Society. Neurology 2000;55:616-23.
ILAE 1993
  • ILAE. Guidelines for epidemiologic studies on epilepsy. Epilepsia 1993;34:592-6.
Joshi 2005
Kevin 2001
  • Gordon KE, Dooley JM, Camfield PR, Camfield CS, MacSween J. Treatment of febrile seizures: the influence of treatment efficacy and side-effect profile on value to parents. Pediatrics 2001;108(5):1080-8.
Kliegman 1996
  • Kliegman R. Seizures. Nelson Essentials of Pediatrics. 5th Edition. Philadelphia: Saunders, 1996:833-5; 838.
Kuturec 1997
  • Kuturec M, Emoto SE, Sofijanov N, Dukovski M, Duma F, Ellenberg JH, et al. Febrile seizures: is the EEG a useful predictor of recurrences?. Clinical Pediatrics 1997;36(1):31-6. [PUBMED: 9007345]
Lefebvre 2009
  • Lefebvre C, Manheimer E, Glanville J. Chapter 6: Searching for studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions Version 5.0.2 [updated September 2009]. The Cochrane Collaboration, 2009. www.cochrane-handbook.org.
Maytal 2000
Millichap 1991
  • Millichap JG. Management of febrile seizures: current concepts and recommendations for phenobarbital and the electroencephalogram. Clinical Electroencephalography 1991;22(1):5-12. [PUBMED: 1991413 ]
Moher 2009
Offringa 2012
Panayiotopoulos CP 2005
  • Panayiotopoulos CP. Chapter 2, Optimal use of the EEG in the diagnosis and management of epilepsies. The Epilepsies: Seizures, Syndromes and Management. Oxfordshire (UK): Bladon Medical Publishing, 2005.
RevMan 2008
  • The Nordic Cochrane Centre, The Cochrane Collaboration. Review Manager (RevMan). 5.0. Copenhagen: The Nordic Cochrane Centre, The Cochrane Collaboration, 2008.
Waruiru 2004
Yucel 2004