Guide Rehab/Consensus Committee – Preparatory project

For more information please email president@sosort.org.

Guide Rehab – A short review

See below for important background literature on this project.

General aims

• Define/describe rehabilitation and complex intervention that is best used to manage the growing child with scoliosis.
• Spread awareness and knowledge of the complexities of this intervention from a clinical and research point of view
• No longer consider single treatment in isolation (Brace is just a plastic orthosis and SSE is not just exercises)
  • The best results is finding the correct combination of CBA, SSE, best possible brace, time in brace and reduce emotional load on patients

Precise Scope of Guide Rehab

• Develop checklist to accurate report intervention studies of comprehensive care for the growing child with scoliosis
• Seeks to ensure that the known or hypothesized active ingredients responsible for target changes are clearly articulated and that, ingredients are linked to the measurable change that they create
• To standardize the reporting of non operative comprehensive interventions in the field of pediatric scoliosis for papers of all study designs

Design: Qualitative study including a Delphi process and consensus

• Directors: Sabrina Donzelli, Dariusz Czaprowski, Stefano Negrini
• Secretary: Prachi Bakarania
• Panel of Experts in alphabetical order and per profession:
  • CPOs: Luke Stikeleather (USA) and Andreas Wuersching (Croatia)
  • SSE specialists: Eric Parent (Canda), Hagit Berdishevsky (Israel), Yavut Yakuz (Turkey)
  • MDs: Benjamin Roye (USA), Calgar Yilgor (Turkey), Angelo Aulisa (Italy)
  • 2 Patients: Joe O’Brien and Alessia Mancini

Inclusion criteria to join expert panel

Expertise	Clinical		Scientific
	Last 15 years		Last 10 years
Prescribers	Minimum 500 patients per year with a prescription of brace + SSE		First/Last/Corresponding author of published papers on braces or SSE
SSE providers	Minimum 100 patients per year treated with SSE and wearing a brace		First/Last/Corresponding author of published papers OR presenter at SOSORT or other international Meetings on SSE
Brace providers	Minimum 500 braced patients per year with minimum 10% performing SSE		First/Last/Corresponding author of published papers OR presenter at SOSORT or other international Meetings on braces
Patients		3 years of treatment with braces and SSE

Delphi Process – Inclusion Criteria

The participants in the delphi rounds and the final consensus must also be experts, with the different that only the clinical criteria from the last 10 years are considered

Expertise	Clinical
	Last 10 years
Prescribers	Minimum 500 patients per year with a prescription of brace and/or SSE
SSE providers	Minimum 100 patients per year treated with SSE
Brace providers	Minimum 500 braced patients per year
Patients	3 years of treatment with braces and SSE

• The Delphi process will be used to establish consensus among experts
• Participants will receive anonymous questionnaires, for 3 rounds and a core group of facilitators will analyze, summarize, and redistribute.
•  In each round, a 5-point Likert scale (“strongly disagree”,
• “disagree”, “neutral”, “agree”, “strongly agree”) used to assess participant agreement on
• each item, and free-text responses will be reviewed by the facilitators for integration into future iterative rounds.

Procedure

Step	Method	Deadlines	Meeting
Definition of the panel	Call	11/1
Definition of the methodology and presentation of GUIDE-Rehab	120’ Meeting	11/1	16/1
Brainstorm to define the preliminary list of targets	90’ Meeting	20/1	23/1
Identification of the targets and collection of other proposals	Delphi	8/2
Presentation of the results Brainstorm to define the ingredients to achieve the first set of identified targets	120’ Meeting	22/2	TBD
Identification of the ingredients of the first set of identified targets and collection of other proposals	Delphi	1/3
Brainstorm to define the ingredients to achieve the second set of identified targets	120’ Meeting	15/3	TBD
Identification of the ingredients of the second set of identified targets and collection of other proposals	Delphi	22/3
Presentation of the results and agreement on elements to discuss at the final Consensus Meeting	120’ Meeting	5/4	TBD
Consensus Conference		29/4	29/4 14-17

Step by Step Procedure

1. Describe the intervention 
2. Definition of the target of each intervention component 
3. What is the underlying intervention theory for each component? (Including published evidence and theories coming from experience)
4. Focus on the targets, ingredients, and components to enhance the description of the intervention theory.
5.  Intervention ingredients and quantity, their tailoring  and quantity changes 

Glossary of terms

Background treatment: All interventions provided to all study participants (intervention and comparison) which are common to both groups..

Intervention type: Classification of the studied intervention, ranging from an intervention component to a complex rehabilitation program. 

Rehabilitation program: A complex intervention that meets all aspects of the definition of rehabilitation for research purposes developed by Cochrane Rehabilitation in collaboration with global stakeholders (A2).

Intervention for rehabilitation: An intervention used in rehabilitation that can be implemented as a stand-alone treatment or a component of a rehabilitation program.

Intervention theory: The biological, psychological and/or social reason(s) why the intervention should work.

Intervention component: The set of active ingredients proposed to change a single intervention target.

Component theory: The biological, psychological and/or social reason(s) why the component should work. 

Intervention target: A measurable aspect of the functioning or contextual factors hypothesized to be directly changed by the active ingredients of the intervention component. It could coincide with one of the intervention outcomes or be an intermediate outcome of the intervention component, allowing for the achievement of the rehabilitation program’s outcome.

Active ingredient: A single constituent of the intervention responsible alone or with other ingredients for the therapeutic action.

Attributes of an active ingredient: Materials, procedures, personnel, mode of delivery, context, and team factors characteristic of intervention delivery.