Transcutaneous posterior tibial nerve stimulation in children and adolescents with functional constipation

Supplemental Digital Content is available in the text


Assessment of Quality of Life in Children and Adolescents with
Fecal Incontinence (AQLCAFI).
- Tannuri  Strategies to improve adherence to intervention protocols, and any procedures for monitoring adherence (eg, drug tablet return, laboratory tests)

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11d Relevant concomitant care and interventions that are permitted or prohibited during the trial ______6,7____ Outcomes 12 Primary, secondary, and other outcomes, including the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome. Explanation of the clinical relevance of chosen efficacy and harm outcomes is strongly recommended ______8______ Participant timeline 13 Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for participants. A schematic diagram is highly recommended (see Figure) _6,7,8, Figure 3_ Sample size 14 Estimated number of participants needed to achieve study objectives and how it was determined, including clinical and statistical assumptions supporting any sample size calculations _______6____ Recruitment 15 Strategies for achieving adequate participant enrolment to reach target sample size _______6,7___

Methods: Assignment of interventions (for controlled trials)
Allocation: Sequence generation 16a Method of generating the allocation sequence (eg, computer-generated random numbers), and list of any factors for stratification. To reduce predictability of a random sequence, details of any planned restriction (eg, blocking) should be provided in a separate document that is unavailable to those who enrol participants or assign interventions How personal information about potential and enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial _______5_____

Declaration of interests 28
Financial and other competing interests for principal investigators for the overall trial and each study site _______1_____ Access to data 29 Statement of who will have access to the final trial dataset, and disclosure of contractual agreements that limit such access for investigators _______9_____ Ancillary and posttrial care 30 Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm from trial participation ______N/A_____ Dissemination policy 31a Plans for investigators and sponsor to communicate trial results to participants, healthcare professionals, the public, and other relevant groups (eg, via publication, reporting in results databases, or other data sharing arrangements), including any publication restrictions ______9______ 31b Authorship eligibility guidelines and any intended use of professional writers ______1,9______ 31c Plans, if any, for granting public access to the full protocol, participant-level dataset, and statistical code ______9_______

Informed consent materials 32
Model consent form and other related documentation given to participants and authorised surrogates __supplemental digital content 2 and 3______ Biological specimens 33 Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in the current trial and for future use in ancillary studies, if applicable ___N/A_______ *It is strongly recommended that this checklist be read in conjunction with the SPIRIT 2013 Explanation & Elaboration for important clarification on the items. Amendments to the protocol should be tracked and dated. The SPIRIT checklist is copyrighted by the SPIRIT Group under the Creative Commons "Attribution-NonCommercial-NoDerivs 3.0 Unported" license.