CONSORT-SPI Data ReadMe File 1. Descriptions of files 1.1 ÒCONSORT-SPI Delphi Process Information Leaflets and Consent FormsÓ contains recruitment materials and the informed consent form 1.2 ÒCONSORT-SPI Delphi Process Round 1 QuestionnaireÓ contains the questions asked in Round 1 of the Delphi process 1.3 ÒCONSORT-SPI Delphi Process Round 2 QuestionnaireÓ contains the questions asked in Round 2 of the Delphi process 1.4 ÒCONSORT-SPI Delphi Process Technical ReportÓ contains information on the objective, participant selection process, and study procedures for the Delphi process 1.5 ÒCONSORT-SPI Delphi Round 1 DataÓ contains the data collected in Round 1 of the Delphi process 1.6 ÒCONSORT-SPI Delphi Round 2 DataÓ contains the data collected in Round 2 of the Delphi process 1.7 ÒCONSORT-SPI Consensus Meeting Technical ReportÓ contains information on the objective, participant selection process, and study procedures for the consensus meeting 1.8 ÒCONSORT-SPI Consensus Meeting VotesÓ contains the data collected in the consensus meeting 2. Relationships between the data filesÊ 2.1 The following data files are from the CONSORT-SPI Delphi process: ÒCONSORT-SPI Delphi Process Information Leaflets and Consent FormsÓ, ÒCONSORT-SPI Delphi Process Round 1 QuestionnaireÓ, ÒCONSORT-SPI Delphi Process Round 2 QuestionnaireÓ, ÒCONSORT-SPI Delphi Process Technical ReportÓ, ÒCONSORT-SPI Delphi Round 1 DataÓ, and ÒCONSORT-SPI Delphi Round 2 DataÓ 2.2 The following data files are from the CONSORT-SPI consensus meeting: ÒCONSORT-SPI Consensus Meeting Technical ReportÓ, ÒCONSORT-SPI Consensus Meeting VotesÓ 3. Explanation of ÒCONSORT-SPI Delphi Round 1 DataÓ - Column A provides the anonymous identification numbers for participants. Participant IDs range from P001 to P384. - Column B provides participant ratings for Delphi Round 1, Question 1. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column C provides participant comments for Delphi Round 1, Question 1. - Column D provides participant ratings for Delphi Round 1, Question 2. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column E provides participant comments for Delphi Round 1, Question 2. - Column F provides participant ratings for Delphi Round 1, Question 3. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column G provides participant comments for Delphi Round 1, Question 3. - Column H provides participant ratings for Delphi Round 1, Question 4. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column I provides participant comments for Delphi Round 1, Question 4. - Column J provides participant ratings for Delphi Round 1, Question 5. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column K provides participant comments for Delphi Round 1, Question 5. - Column L provides participant ratings for Delphi Round 1, Question 6. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column M provides participant comments for Delphi Round 1, Question 6. - Column N provides participant ratings for Delphi Round 1, Question 7. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column O provides participant comments for Delphi Round 1, Question 7. - Column P provides participant ratings for Delphi Round 1, Question 8. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column Q provides participant comments for Delphi Round 1, Question 8. - Column R provides participant ratings for Delphi Round 1, Question 9. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column S provides participant comments for Delphi Round 1, Question 9. - Column T provides participant ratings for Delphi Round 1, Question 10. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column U provides participant comments for Delphi Round 1, Question 10. - Column V provides participant ratings for Delphi Round 1, Question 11. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column W provides participant comments for Delphi Round 1, Question 11. - Column X provides participant ratings for Delphi Round 1, Question 12. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column Y provides participant comments for Delphi Round 1, Question 12. - Column Z provides participant ratings for Delphi Round 1, Question 12a. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column AA provides participant comments for Delphi Round 1, Question 12a. - Column AB provides participant ratings for Delphi Round 1, Question 13. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column AC provides participant comments for Delphi Round 1, Question 13. - Column AD provides participant ratings for Delphi Round 1, Question 14. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column AE provides participant comments for Delphi Round 1, Question 14. - Column AF provides participant ratings for Delphi Round 1, Question 15. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column AG provides participant comments for Delphi Round 1, Question 15. - Column AH provides participant ratings for Delphi Round 1, Question 16. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column AI provides participant comments for Delphi Round 1, Question 16. - Column AJ provides participant ratings for Delphi Round 1, Question 17. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column AK provides participant comments for Delphi Round 1, Question 17. - Column AL provides participant ratings for Delphi Round 1, Question 18. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column AM provides participant comments for Delphi Round 1, Question 18. - Column AN provides participant ratings for Delphi Round 1, Question 19. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column AO provides participant comments for Delphi Round 1, Question 19. - Column AP provides participant ratings for Delphi Round 1, Question 20. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column AQ provides participant comments for Delphi Round 1, Question 20. - Column AR provides participant ratings for Delphi Round 1, Question 21. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column AS provides participant comments for Delphi Round 1, Question 21. - Column AT provides participant ratings for Delphi Round 1, Question 22. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column AU provides participant comments for Delphi Round 1, Question 22. - Column AV provides participant ratings for Delphi Round 1, Question 23. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column AW provides participant comments for Delphi Round 1, Question 23. - Column AX provides participant ratings for Delphi Round 1, Question 24. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column AY provides participant comments for Delphi Round 1, Question 24. - Column AZ provides participant ratings for Delphi Round 1, Question 25a. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column BA provides participant comments for Delphi Round 1, Question 25a. - Column BB provides participant ratings for Delphi Round 1, Question 25b. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column BC provides participant comments for Delphi Round 1, Question 25b. - Column BD provides participant ratings for Delphi Round 1, Question 25c. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column BE provides participant comments for Delphi Round 1, Question 25c. - Column BF provides participant ratings for Delphi Round 1, Question 26. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column BG provides participant comments for Delphi Round 1, Question 26. - Column BH provides participant ratings for Delphi Round 1, Question 27. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column BI provides participant comments for Delphi Round 1, Question 27. - Column BJ provides participant ratings for Delphi Round 1, Question 28. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column BK provides participant comments for Delphi Round 1, Question 28. - Column BL provides participant ratings for Delphi Round 1, Question 29. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column BM provides participant comments for Delphi Round 1, Question 29. - Column BN provides participant ratings for Delphi Round 1, Question 30. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column BO provides participant comments for Delphi Round 1, Question 30. - Column BP provides participant ratings for Delphi Round 1, Question 31. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column BQ provides participant comments for Delphi Round 1, Question 31. - Column BR provides participant ratings for Delphi Round 1, Question 32. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column BS provides participant comments for Delphi Round 1, Question 32. - Column BT provides participant ratings for Delphi Round 1, Question 33. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column BU provides participant comments for Delphi Round 1, Question 33. - Column BV provides participant ratings for Delphi Round 1, Question 34. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column BW provides participant comments for Delphi Round 1, Question 34. - Column BX provides participant ratings for Delphi Round 1, Question 35. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column BY provides participant comments for Delphi Round 1, Question 35. - Column BZ provides participant ratings for Delphi Round 1, Question 36. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column CA provides participant comments for Delphi Round 1, Question 36. - Column CB provides participant ratings for Delphi Round 1, Question 37. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column CC provides participant comments for Delphi Round 1, Question 37. - Column CD provides participant ratings for Delphi Round 1, Question 38a. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column CE provides participant comments for Delphi Round 1, Question 38a. - Column CF provides participant ratings for Delphi Round 1, Question 38b. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column CG provides participant comments for Delphi Round 1, Question 38b. - Column CH provides participant ratings for Delphi Round 1, Question 39. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column CI provides participant comments for Delphi Round 1, Question 39. - Column CJ provides participant ratings for Delphi Round 1, Question 40. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column CK provides participant comments for Delphi Round 1, Question 40. - Column CL provides participant ratings for Delphi Round 1, Question 41. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column CM provides participant comments for Delphi Round 1, Question 41. - Column CN provides participant ratings for Delphi Round 1, Question 42. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column CO provides participant comments for Delphi Round 1, Question 42. - Column CP provides participant ratings for Delphi Round 1, Question 43. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column CQ provides participant comments for Delphi Round 1, Question 43. - Column CR provides participant ratings for Delphi Round 1, Question 44. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column CS provides participant comments for Delphi Round 1, Question 44. - Column CT provides participant ratings for Delphi Round 1, Question 45. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column CU provides participant comments for Delphi Round 1, Question 45. - Column CV provides participant ratings for Delphi Round 1, Question 46. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column CW provides participant comments for Delphi Round 1, Question 46. - Column CX provides participant ratings for Delphi Round 1, Question 47a. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column CY provides participant comments for Delphi Round 1, Question 47a. - Column CZ provides participant ratings for Delphi Round 1, Question 47b. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column DA provides participant comments for Delphi Round 1, Question 47b. - Column DB provides participant ratings for Delphi Round 1, Question 47c. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column DC provides participant comments for Delphi Round 1, Question 47c. - Column DD provides participant ratings for Delphi Round 1, Question 48a. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column DE provides participant comments for Delphi Round 1, Question 48a. - Column DF provides participant ratings for Delphi Round 1, Question 48b. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column DG provides participant comments for Delphi Round 1, Question 48b. - Column DH provides participant ratings for Delphi Round 1, Question 49a. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column DI provides participant comments for Delphi Round 1, Question 49a. - Column DJ provides participant ratings for Delphi Round 1, Question 49b. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column DK provides participant comments for Delphi Round 1, Question 49b. - Column DL provides participant ratings for Delphi Round 1, Question 49c. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column DM provides participant comments for Delphi Round 1, Question 49c. - Column DN provides participant ratings for Delphi Round 1, Question 50a. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column DO provides participant comments for Delphi Round 1, Question 50a. - Column DP provides participant ratings for Delphi Round 1, Question 50b. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column DQ provides participant comments for Delphi Round 1, Question 50b. - Column DR provides participant ratings for Delphi Round 1, Question 50c. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column DS provides participant comments for Delphi Round 1, Question 50c. - Column DT provides participant ratings for Delphi Round 1, Question 51. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column DU provides participant comments for Delphi Round 1, Question 51. - Column DV provides participant ratings for Delphi Round 1, Question 52a. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column DW provides participant comments for Delphi Round 1, Question 52a. - Column DX provides participant ratings for Delphi Round 1, Question 52b. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column DY provides participant comments for Delphi Round 1, Question 52b. - Column DZ provides participant ratings for Delphi Round 1, Question 53. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column EA provides participant comments for Delphi Round 1, Question 53. - Column EB provides participant ratings for Delphi Round 1, Question 54. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column EC provides participant comments for Delphi Round 1, Question 54. - Column ED provides participant ratings for Delphi Round 1, Question 55. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column EE provides participant comments for Delphi Round 1, Question 55. - Column EF provides participant ratings for Delphi Round 1, Question 56. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column EG provides participant comments for Delphi Round 1, Question 56. - Column EH provides participant ratings for Delphi Round 1, Question 57. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column EI provides participant comments for Delphi Round 1, Question 57. - Column EJ provides participant ratings for Delphi Round 1, Question 58. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column EK provides participant comments for Delphi Round 1, Question 58. - Column EL provides participant ratings for Delphi Round 1, Question 59. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column EM provides participant comments for Delphi Round 1, Question 59. - Column EN provides participant ratings for Delphi Round 1, Question 60. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column EO provides participant comments for Delphi Round 1, Question 60. - Column EP provides participant ratings for Delphi Round 1, Question 61. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column EQ provides participant comments for Delphi Round 1, Question 61. - Column ER provides participant ratings for Delphi Round 1, Question 62. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column ES provides participant comments for Delphi Round 1, Question 62. - Column ET provides participant ratings for Delphi Round 1, Question 63. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column EU provides participant comments for Delphi Round 1, Question 63. - Column EV provides participant ratings for Delphi Round 1, Question 64. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column EW provides participant comments for Delphi Round 1, Question 64. - Column EX provides participant ratings for Delphi Round 1, Question 65. Ratings range from Ò1Ó (ÒNot ImportantÓ) to Ò10Ó (ÒVery ImportantÓ). - Column EY provides participant comments for Delphi Round 1, Question 65. - Column EZ provides additional items to consider for the CONSORT-SPI checklist provided by Delphi Round 1 participants. - Column FA provides any remaining comments participants had about the Delphi Round 1 questionnaire. - Column FB provides each participantÕs country. - Column FC provides each participantÕs gender. - Column FD provides each participants age: Ò1Ó = Ò<34Ó, Ò2Ó = Ò35-44Ó, Ò3Ó = Ò45-54Ó, Ò4Ó = Ò55-64Ó, and Ò5Ó = Ò>65 yearsÓ 4. Explanation of ÒCONSORT-SPI Delphi Round 2 DataÓ - Column A provides the anonymous identification numbers for participants. Participant IDs range from P001 to P383. - Column B provides participant comments about the items that reached consensus in the Delphi Round 1 questionnaire to be included in the CONSORT-SPI guideline. - Column C provides participant ratings for the Delphi Round 2 Title and Abstract item: ÒThe intervention and the target problem/population should be identified in the titleÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column D provides participant ratings for the Delphi Round 2 Title and Abstract item: ÒThe abstract should identify the population, all intervention and control conditions, outcomes of interest, times of follow-up, and the trial settingÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column E provides participant comments for Delphi Round 2 items proposed for the Title and Abstract. - Column F provides participant ratings for the Delphi Round 2 Introduction item: ÒIdentify any evidence-based interventions for this problem/issue and how the experimental intervention differsÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column G provides participant ratings for the Delphi Round 2 Introduction item: ÒMention current knowledge about the effectiveness of the experimental intervention (e.g., reference previous systematic reviews)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column H provides participant ratings for the Delphi Round 2 Introduction item: ÒProvide a conceptual framework or logic model for how the intervention is hypothesised to lead to changes in outcomesÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column I provides participant ratings for the Delphi Round 2 Introduction item: ÒWhether each objective or hypothesis pertains to the individual participant level and/or cluster level (e.g., family, community)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column J provides participant ratings for the Delphi Round 2 Introduction item: ÒJustification for each objective or hypothesisÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column K provides participant comments for Delphi Round 2 items proposed for the Introduction. - Column L provides participant ratings for the Delphi Round 2 ÒMethods: Trial Design, Randomisation and Blinding ProceduresÓ item: ÒIncentives offered to participants (e.g., to enrol in the trial, use the intervention, complete outcome measures)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column M provides participant ratings for the Delphi Round 2 ÒMethods: Trial Design, Randomisation and Blinding ProceduresÓ item: ÒRationale for choice of the control/comparator intervention(s) in the trialÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column N provides participant ratings for the Delphi Round 2 ÒMethods: Trial Design, Randomisation and Blinding ProceduresÓ item: ÒWhether and how data analysts were blind after assignment to identifying information about participantsÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column O provides participant ratings for the Delphi Round 2 ÒMethods: Trial Design, Randomisation and Blinding ProceduresÓ item: ÒWhether maintenance of blinding data analysts was assessedÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column P provides participant ratings for the Delphi Round 2 ÒMethods: Trial Design, Randomisation and Blinding ProceduresÓ item: ÒDiscuss reasons for lack of blinding at any stage (e.g., impossible to blind participants to their assigned intervention)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column Q provides participant ratings for the Delphi Round 2 ÒMethods: Trial Design, Randomisation and Blinding ProceduresÓ item: ÒAny methods to address lack of blinding (e.g., participants unaware content of comparator to minimise demand characteristics)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column R provides participant ratings for the Delphi Round 2 ÒMethods: Trial Design, Randomisation and Blinding ProceduresÓ item: ÒDescription of similarities and differences in content and delivery between intervention(s) and comparator(s)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column S provides participant comments for Delphi Round 2 items proposed for the ÒMethods: Trial Design, Randomisation and Blinding ProceduresÓ Section. - Column T provides participant ratings for the Delphi Round 2 ÒMethods: SettingsÓ item: ÒDates/timings of study procedures by trial arm (e.g., recruitment, baseline, intervention, and follow-up)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column U provides participant ratings for the Delphi Round 2 ÒMethods: SettingsÓ item: ÒGeographic location of the trial (e.g., rural setting in Southwest US, urban setting in London, UK)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column V provides participant ratings for the Delphi Round 2 ÒMethods: SettingsÓ item: ÒCharacteristics of practice setting(s) directly related to experiences of participants and providers (e.g., provider/participant ratio, physical space to run intervention)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column W provides participant ratings for the Delphi Round 2 ÒMethods: SettingsÓ item: ÒCharacteristics of the larger implementing organisation(s) that shape the practice setting (e.g., private/public school ownership, competing priorities to prison-based intervention)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column X provides participant ratings for the Delphi Round 2 ÒMethods: SettingsÓ item: ÒCharacteristics of the external environment relevant to the trial (e.g., community demographics, health/social care policies)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column Y provides participant comments for Delphi Round 2 items proposed for the ÒMethods: SettingsÓ Section. - Column Z provides participant ratings for the Delphi Round 2 ÒMethods: InterventionsÓ item: ÒDescribe the plan for staff recruitment and selection for the intervention(s) and comparator(s)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AA provides participant ratings for the Delphi Round 2 ÒMethods: InterventionsÓ item: ÒDescribe the plan for staff training and support for the intervention(s) and comparator(s)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AB provides participant ratings for the Delphi Round 2 ÒMethods: InterventionsÓ item: ÒDescribe the planned physical and technical resources for the intervention(s) and comparator(s)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AC provides participant ratings for the Delphi Round 2 ÒMethods: InterventionsÓ item: ÒDescribe any piloting of the intervention(s) with providers and the implementing organisation(s) prior to commencing the trialÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AD provides participant ratings for the Delphi Round 2 ÒMethods: InterventionsÓ item: ÒDescribe how and by whom actual delivery and uptake of the intervention by providers and participants was assessedÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AE provides participant ratings for the Delphi Round 2 ÒMethods: InterventionsÓ item: ÒAny methods to investigate intervention causal mechanisms (qualitative/quantitative exploration of hypothesised mediators)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AF provides participant ratings for the Delphi Round 2 ÒMethods: InterventionsÓ item: ÒAny methods to investigate contextual influences on intervention outcomes (e.g., qualitative/quantitative exploration of the dependence of outcomes on practice setting, implementing organisation, or external environment)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AG provides participant comments for Delphi Round 2 items proposed for the ÒMethods: InterventionsÓ Section. - Column AH provides participant ratings for the Delphi Round 2 ÒMethods: Outcomes and Data AnalysisÓ item: ÒDescribe measures used in all reported analyses, including mode of administration and any modifications to pre-existing measuresÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AI provides participant ratings for the Delphi Round 2 ÒMethods: Outcomes and Data AnalysisÓ item: ÒInformation about each measure's psychometric properties in the trial (e.g., internal consistency of self-report measures)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AJ provides participant ratings for the Delphi Round 2 ÒMethods: Outcomes and Data AnalysisÓ item: ÒReference(s) to any validation studies for each measure, noting comparability of their population(s) and context(s) to the trial'sÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AK provides participant ratings for the Delphi Round 2 ÒMethods: Outcomes and Data AnalysisÓ item: ÒMethods used to enhance the quality of measurements in the trial (e.g., multiple observations, training of assessors)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AL provides participant ratings for the Delphi Round 2 ÒMethods: Outcomes and Data AnalysisÓ item: ÒIdentify all outcome measures in the trial, and if these match the trial registration/protocolÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AM provides participant ratings for the Delphi Round 2 ÒMethods: Outcomes and Data AnalysisÓ item: ÒIf done, what variables were used for imputationÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AN provides participant ratings for the Delphi Round 2 ÒMethods: Outcomes and Data AnalysisÓ item: ÒIf done, the number of imputations performedÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AO provides participant ratings for the Delphi Round 2 ÒMethods: Outcomes and Data AnalysisÓ item: ÒAny transformations or changes to raw quantitative data, with reasonsÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AP provides participant comments for Delphi Round 2 items proposed for the ÒMethods: Outcomes and Data AnalysisÓ Section. - Column AQ provides participant ratings for the Delphi Round 2 ÒResults: Baseline and Outcomes DataÓ item: ÒData for demographic, socioeconomic, and other participant characteristics measured at baseline per trial armÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AR provides participant ratings for the Delphi Round 2 ÒResults: Baseline and Outcomes DataÓ item: ÒDescribe whether and how the study completers differ from the original sample on baseline characteristics per trial armÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AS provides participant ratings for the Delphi Round 2 ÒResults: Baseline and Outcomes DataÓ item: ÒReport or refer readers to documents reporting analyses additional to main effects (e.g., subgroups; adjusted analyses)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AT provides participant ratings for the Delphi Round 2 ÒResults: Baseline and Outcomes DataÓ item: ÒDistinguish pre-specified from exploratory analysesÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AU provides participant ratings for the Delphi Round 2 ÒResults: Baseline and Outcomes DataÓ item: ÒProvide raw data set needed for replicating analyses (either in online supplement or indicate how to obtain data on request)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AV provides participant ratings for the Delphi Round 2 ÒResults: Baseline and Outcomes DataÓ item: ÒAny adverse psychological events or unanticipated social disadvantage to individuals or clusters (e.g., families, communities)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AW provides participant comments for Delphi Round 2 items proposed for the ÒMethods: Baseline and Outcomes DataÓ Section. - Column AX provides participant ratings for the Delphi Round 2 ÒResults: Process EvaluationÓ item: ÒActual professional qualifications of providers (rather than per the study protocol)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AY provides participant ratings for the Delphi Round 2 ÒResults: Process EvaluationÓ item: ÒActual training to deliver the intervention(s) (rather than per the study protocol)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column AZ provides participant ratings for the Delphi Round 2 ÒResults: Process EvaluationÓ item: ÒActual supervision of providers across groups (rather than per the study protocol)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BA provides participant ratings for the Delphi Round 2 ÒResults: Process EvaluationÓ item: ÒDetails of any other identified barriers and facilitators of implementing the intervention(s)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BB provides participant ratings for the Delphi Round 2 ÒResults: Process EvaluationÓ item: ÒDescribe any information about the acceptability or perceived value of the intervention(s) and comparator(s) by participantsÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BC provides participant ratings for the Delphi Round 2 ÒResults: Process EvaluationÓ item: ÒResults of any investigations of causal mechanisms of the interventionÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BD provides participant ratings for the Delphi Round 2 ÒResults: Process EvaluationÓ item: ÒResults of any investigations of contextual influences on intervention outcomesÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BE provides participant comments for Delphi Round 2 items proposed for the ÒResults: Process EvaluationÓ Section. - Column BF provides participant ratings for the Delphi Round 2 ÒDiscussionÓ item: ÒInterpretation of the results, considering pre-specified and alternative hypothesesÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BG provides participant ratings for the Delphi Round 2 ÒDiscussionÓ item: ÒPopulation(s) to whom the results may apply, considering sample characteristics, the intended population, recruitment procedures, and related studiesÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BH provides participant ratings for the Delphi Round 2 ÒDiscussionÓ item: ÒSetting(s) to which the results may apply, considering intervention implementation, choice of comparator, trial context, and related studiesÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BI provides participant ratings for the Delphi Round 2 ÒDiscussionÓ item: ÒInterpretation of any results about moderators and mediators, considering other relevant evidence and study limitationsÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BJ provides participant ratings for the Delphi Round 2 ÒDiscussionÓ item: ÒLimitations due to sources of potential bias and imprecisionÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BK provides participant ratings for the Delphi Round 2 ÒDiscussionÓ item: ÒLimitations due to heterogeneity (e.g., variability in the participants, intervention implementation, and outcomes)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BL provides participant ratings for the Delphi Round 2 ÒDiscussionÓ item: ÒLimitations of methods to investigate intervention implementation (e.g., provider delivery and participant uptake)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BM provides participant ratings for the Delphi Round 2 ÒDiscussionÓ item: ÒImplications of trial findings to future research, policy, and practice, commensurate with strengths and limitations of the studyÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BN provides participant comments for Delphi Round 2 items proposed for the ÒDiscussionÓ Section. - Column BO provides participant ratings for the Delphi Round 2 ÒOther InformationÓ item: ÒRegistration number and name of trial registry, or reasons why trial was not registeredÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BP provides participant ratings for the Delphi Round 2 ÒOther InformationÓ item: ÒDetails about ethical approval (body giving approval/study identification number, informed consent procedures, any important ethical considerations)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BQ provides participant ratings for the Delphi Round 2 ÒOther InformationÓ item: ÒReferences to external sources with information about the methods and outcomes of this trial, such as the full trial protocol and other papers/reports about the trialÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BR provides participant ratings for the Delphi Round 2 ÒOther InformationÓ item: ÒReport any involvement of the intervention developer in the design, conduct, analysis, and reporting of the trialÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BS provides participant ratings for the Delphi Round 2 ÒOther InformationÓ item: ÒAny potential conflicts of interestÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BT provides participant ratings for the Delphi Round 2 ÒOther InformationÓ item: ÒHow any identified potential conflicts of interest were handledÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BU provides participant comments for Delphi Round 2 items proposed for the ÒOther InformationÓ Section. - Column BV provides participant ratings for the Delphi Round 2 ÒAdditional Items Proposed in Round 1Ó item: ÒDirect costs of implementing the intervention (e.g., provider salary, necessary material resources, training and supervision)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BW provides participant ratings for the Delphi Round 2 ÒAdditional Items Proposed in Round 1Ó item: ÒPresent results of power analyses (i.e., power for outcome analyses at each follow-up)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BX provides participant ratings for the Delphi Round 2 ÒAdditional Items Proposed in Round 1Ó item: ÒAny methods to avoid or minimise contamination or spillover effects in the trial (e.g., participants in a comparator group receiving the experimental intervention)Ó. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BY provides participant ratings for the Delphi Round 2 ÒAdditional Items Proposed in Round 1Ó item: ÒStakeholder involvement in trial design, conduct, and/or analyses (e.g., practitioners, policy-makers, participant representativesÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column BZ provides participant ratings for the Delphi Round 2 ÒAdditional Items Proposed in Round 1Ó item: ÒAcknowledgements of those who contributed substantially to the project but did not meet authorship requirementsÓ. Participants had three rating options: Ò1Ó = ÒIncludeÓ, Ò2Ó = ÒExcludeÓ, and Ò3Ó = Unsure. - Column CA provides participant comments for Delphi Round 2 items proposed for the ÒAdditional Items Proposed in Round 1Ó Section. - Column CB provides participant comments for the Delphi Round 2 questionnaire generally. 5. Explanation of ÒCONSORT-SPI Consensus Meeting VotesÓ - Column A indicates the day of the 3-day consensus meeting on which the vote to include the proposed item was conducted. Votes took place on either Day 2 or Day 3 of the consensus meeting. - Column B indicates the voted on items. - Column C indicates the percentage of participants who voted to include the item in the CONSORT-SPI checklist. - Column D indicates the percentage of participants who voted to exclude the item in the CONSORT-SPI checklist. - Column E indicates the percentage of participants who voted that they were unsure as to whether the item should be included or excluded in the CONSORT-SPI checklist. - Column E indicates the percentage of participants who did not provide a vote on including or excluding the item in the CONSORT-SPI checklist.