Intervention Protocol

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Dietary interventions for recurrent abdominal pain in childhood

  1. Alice E Martin1,*,
  2. Tamsin V Newlove-Delgado2,
  3. Rebecca A Abbott2,
  4. Alison Bethel2,
  5. Joanna Thompson-Coon2,
  6. Vasilis Nikolaou3,
  7. Stuart Logan2

Editorial Group: Cochrane Developmental, Psychosocial and Learning Problems Group

Published Online: 14 FEB 2014

DOI: 10.1002/14651858.CD010972


How to Cite

Martin AE, Newlove-Delgado TV, Abbott RA, Bethel A, Thompson-Coon J, Nikolaou V, Logan S. Dietary interventions for recurrent abdominal pain in childhood (Protocol). Cochrane Database of Systematic Reviews 2014, Issue 2. Art. No.: CD010972. DOI: 10.1002/14651858.CD010972.

Author Information

  1. 1

    Royal Devon and Exeter Hospital, Paediatrics, Exeter, England, UK

  2. 2

    University of Exeter, Peninsula CLAHRC, University of Exeter Medical School, Exeter, England, UK

  3. 3

    University of Exeter, Institute of Health Research, University of Exeter Medical School, Exeter, Devon, UK

*Alice E Martin, Paediatrics, Royal Devon and Exeter Hospital, Barrack Road, Exeter, England, EX2 5DW, UK. alice.martin@doctors.org.uk.

Publication History

  1. Publication Status: New
  2. Published Online: 14 FEB 2014

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Table 1. Assessment of risk of bias in included studies

DomainRisk of bias judgement

LowHighUnclear

Selection bias 

Random sequence generationIf the study details any of the following methods: simple randomisation (such as coin-tossing, throwing dice or dealing previously shuffled cards, a list of random numbers, or computer generated random numbers) or restricted randomisation: blocked, ideally with varying block sizes or stratified groups, provided that within groups randomisation is not affected.If the study details no randomisation or other inadequate method such as alternation, assignment based on date of birth, case record number, and date of presentation. These may be referred to as ‘quasi-random’.If there is not sufficient detail to judge the risk of bias.

 

Allocation concealmentIf the study details concealed allocation sequence in sufficient detail to determine that allocations could not have been foreseen in advance of or during enrolment.If the study details a method where the allocation is known prior to assignment.If there is not sufficient detail to judge the risk of bias. 

Performance bias 

Blinding of participants and personnelIf the study details a method of blinding the participants and personnel. This requires sufficient detail to show they were unable to identify the therapeutic intervention from control intervention.Considering the nature of the interventions, the participants and therapists may not be able to be blinded. The effect of this will be addressed in the discussion.If there is not sufficient detail to judge the risk of bias.

Detection bias 

Blinding of outcome assessmentIf the study details a blinded outcome assessment. This may only be possible for outcomes that are externally assessed.If the outcome assessment is not blinded. We expect this may be unavoidable for self-rated outcomes of unblinded interventions.If there is not sufficient detail to judge the risk of bias.

 

Attrition bias

Incomplete outcome data If the study reports attrition and exclusions, including the numbers in each intervention group (compared with total randomised participants), reasons for attrition or exclusions, and any re-inclusions. And the impact of missing data is not felt to alter the conclusions, and there are acceptable reasons for the missing data.We may judge the risk of attrition bias to be high due to the amount, nature or handling (such as per-protocol analysis) of incomplete outcome data.If there is not sufficient detail to judge the risk of bias. For example, if the number of people randomised to each treatment is not reported.

Reporting bias

Selective reportingIf there is judged to be complete reporting, this will be found on comparison of the protocol and published study, if available.If the reporting is selective, so some outcome data is not reported.If there is not sufficient detail to judge the risk of bias, such as protocols not available.