Additional Instructions That Must Be Followed for This Funding Opportunity

Appendix B: Data Abstraction Forms

FORM I. GENERAL INFORMATION 1 Study ID 2 Reviewers’  Avrahami  Coomes  Malik . . Last name  Brunarski  Connell  Ngo  Bruno  Ebrahim  Riva  Burnie  Kirmayr  Steenstra  Busse  LeBlanc  Torrance  Bala  Jankowski  Lesniak  Alexander  Faulhaber 9 Last 1 Publication status  Peer-reviewed publication . name of 0.  Conference abstract first  Other, specify: author  Unpublished 1 Full 1 Year 1 Language  English 1 Journal 2. 3.  Non-English , . Name specify: ______1 Funding  Exclusively industry-  No industry  Not reported 4 funded funding  Explicit statement-no .  Partially industry-funded  Funding funding unspecified 1 Conflict  Yes, one or more of the  No conflicts of  Not reported 5 of authors are employees of a interest . Interest company with a vested interest in the trial Type of  Prolonged follow 1  Main report 6 report up  Other, specify: .  Report of subgroup  Report of . secondary outcome 16.1. If this is not main report, please specify the study ID of the main report associated with this study, and the reference citation of the main report 17. Did the trial start enrolment after July 1, 2005?  Yes  No  Not reported 17. If so, is the trial registered?  Yes, provide  No/not reported 1. details:_____

Comment – Form I

1 FORM II. STUDY CHARACTERISTICS 18. Where was this study conducted  Canada  United States Check all that apply  United Kingdom  Other Europe  Japan  Other Asia  Africa  Australia  New Zealand  South America  Not reported 19. Number of sites  Single site  2-5 sites  6-10 sites  > 10 sites  Not reported 20. Study design  Parallel trial  Cross-over trial  Factorial trial  N-of-1 trial  Cluster trial 21. Primary outcome(s)  Specified: ______ Not specified 22. Number of applicable arms  2  3  4  Other, specify 23. Number of individual approached to take part in the  Reported, specify: ______study who chose not to participate  Not reported 24. Did the trial authors implement a pre-randomization  Yes period?  No 24. If so, what reason was provided?  To establish severity and variability of pain 1.  To identify and exclude patients with high responses to placebo (placebo run-in period)  To identify and exclude patients with intolerable side effects to study treatment (active treatment run-in period)  To treat all patients with the active therapy, and then only randomize responders  To identify and exclude on-adherent patients  Other reason (specify)

2 FORM II. STUDY CHARACTERISTICS - continued 25. Was involvement in litigation reported?  Yes  No  Unclear 25. If so, was involvement in litigation used as exclusion  Yes 1. criteria?  No

26. Was receipt of disability benefits or other wage  Yes replacement benefits reported?  No  Unclear 26. If so, was receipt of disability benefits or other wage  Yes 1. replacement benefits used as exclusion criteria?  No

27. Duration of treatment (check 1 only)  Days:______ Weeks: ______ Months: ______ Years: ______28. Frequency of treatment (check 1 only)  Not applicable  Times per day: ______ Times per week: ______ Times per month: ______29. Duration of the individual treatment unit (check 1  Not applicable only)  Minutes: ______ Hours: ______ Other, specify: ______30. Length of follow up from randomization  Fixed period → (expand if selected)  Variable period (complete all the following as appropriate) → Minimum (expand if selected) → Maximum (expand if selected) → Median (expand if selected) → Mean (expand if selected) → Person years .

Comment – Form II

3 FORM III. RISK OF BIAS

4 3 How was the  Computer generated randomization scheme 2 randomization sequence  Random number table . generated?  Tossing coin  Rolling of a dice  Picking allocation from a hat/box  Minimization/dynamic allocation  Other, specify .  Not reported 3 Was allocation adequately  Definitely yes 3 concealed?  Probably yes .  Probably no  Definitely no 3 How was allocation  Sequentially numbered, opaque, sealed envelope 4 concealed?  Sequentially coded medication containers .  Central randomization (including telephone, web-based and pharmacy-controlled randomization);  Open random allocation schedule(open-label)  “Concealed”, no method described  Other, specify : ______ Not concealed  Not reported 3 Blinding of patients 5  Definitely yes  Probably yes  Probably no  Definitely no . 3 Blinding of health Care 6 providers  Definitely yes  Probably yes  Probably no  Definitely no . 3 Blinding of data collectors 7  Definitely yes  Probably yes  Probably no  Definitely no . 3 Blinding of outcome 8 assessors  Definitely yes  Probably yes  Probably no  Definitely no . 3 Blinding of data analysts 9  Definitely yes  Probably yes  Probably no  Definitely no . 4 Study stopped early for  Yes  No  No clear statement 0 benefit . 4 Study stopped early for  Yes  No  No clear statement 1 harm . 4 Whether patients were 2 analyzed in the groups to  Yes  No  Not reported . which they were randomized?

5 FORM III. RISK OF BIAS - continued 1 Lost to follow up (LTFU) explicitly  Explicit  Explicit statement:  No explicit . reported statement: LTFU LTFU did not occur statement about occurred LTFU 2 LTFU reported separately for  Yes  No  No explicit . each study arm statement about LTFU 3 LTFU reported relative to each  Yes  No  N/A (only one . planned follow-up planned)  N/A (no LTFU) 4 Implications of LTFU discussed  Yes  No  N/A . 5 Method of dealing with LTFU  Yes (open table  No  N/A . explicitly described below)

Comment – Form III

FORM IV. INTERVENTIONS 4 Treatment Arm 1  Analgesic: code ______3. (check all that apply)  Anesthetic: code ______ Anticonvulsant: code ______ Anti-Depressant: code ______ Anti-Emetic: code ______

 Anti-hypertensive: code ______ Anti-Inflammatory: code ______ Anti-Viral: code ______

 Bone Growth Stimulant: code ______ Complementary & Alternative Therapy: code ______ Dopamine Agonist: code ______ Exercise: code ______ Hormone Therapy: code ______ Immunological Modifier: code ______ Lifestyle Modification: code ______ Muscle Relaxant: code ______ Nutrition & Supplements: code ______ Psychotherapy: code ______ Sedative: code ______ Serotonin Antagonist: code ______ Stimulant: code ______

6 FORM IV. INTERVENTIONS 6 Treatment Arm 2  Analgesic: code ______4. (check all that apply)  Anesthetic: code ______ Anticonvulsant: code ______ Anti-Depressant: code ______ Anti-Emetic: code ______

7 FORM IV. INTERVENTIONS 8 Treatment Arm 3  Analgesic: code ______5. (check all that apply)  Anesthetic: code ______ Anticonvulsant: code ______ Anti-Depressant: code ______ Anti-Emetic: code ______

8 FORM IV. INTERVENTIONS 1 Control Arm  Analgesic: code ______0 (check all that apply)  6. Anesthetic: code ______ Anticonvulsant: code ______ Anti-Depressant: code ______ Anti-Emetic: code ______

 Bone Growth Stimulant: code ______ Complementary & Alternative Therapy: code ______ Dopamine Agonist: code ______ Exercise: code ______ Hormone Therapy: code ______ Immunological Modifier: code ______ Lifestyle Modification: code ______ Muscle Relaxant: code ______ Nutrition & Supplements: code ______ Placebo  Psychotherapy: code ______ Sedative: code ______ Serotonin Antagonist: code ______ Stimulant: code ______ Waiting List

Comment – Form IV

9 Form V: PATIENT CHARACTERISTICS

1 What clinical conditions were studied?  Fibromyalgia 2  Generalized myofascial pain syndrome 9  Fibrositis .  Muscular rheumatism  Chronic, generalized pain syndrome 1 Were explicit criteria used to identify participants?  Unequivocal clear and explicit criteria 3  Some criteria, but not as clear or explicit as desirable 0  Uncertain .  Not reported  Reported in a prior publication 1 Did ≥50% of participants clearly meet the diagnostic  Yes 3 criteria for fibromyalgia according to the American  No 1 College of Rheumatology [ACR] criteria, 1990?  Uncertain . Measure Tx Group 1 Tx Group 2 Tx Group 3 Control Arm Total

10 1 Duration of chronic pain condition , , , , , 3 before randomization (in years) Mean, SD . . . . . 2  Not reported , , , , , . Median, IQR . . . . . 1 Age (year) , , , , , 3  Not reported Mean, SD . . . . . 4 , , , , , . Median, IQR . . . . . 1 Number of female participants 3  Not reported 6 . Raw number 1 Involved in litigation 3  Not reported 7 . Raw number 1 Receiving disability or other wage 3 replacement benefits 8  Not reported . Raw number 1 Intensity of required participation 3 9  High  High  High  High  High .  Low  Low  Low  Low  Low 1 Compliance with treatment 4  Not reported 0 . Percentage

Comment – Form V

11 FORM VI: PARTICIPANT FLOW THROUGH STUDY Tx Group 1 Tx Group 2 Tx Group 3 Control arm Total 14 Patients randomized (raw number) 1.  Not reported

14 Patients mistakenly randomized, appropriately 2. excluded (raw number)  Not reported 14 Patients mistakenly randomized, 3. inappropriately excluded (raw number)  Not reported 14 Lost to follow-up: withdrew consent (raw 4. number)  Not reported 14 Lost to follow-up: withdrew due to adverse 5. effects (raw number)  Not reported 14 Lost to follow-up: withdrew due to lack of 6. improvement (raw number)  Not reported 14 Lost to follow-up: withdrew due to loss of 7. contact or migration (raw number)  Not reported 14 Lost to follow-up: withdrew due to Other 8. Reasons (raw number)  Not reported

12 FORM VII: OUTCOMES

149. Binary Outcome Number of events / total (denominator)  Reported Tx Group 1 Tx Group 2 Tx Group 3 Control Arm  Not reported → skip this table Events Total Person- Events Total Person- Events Total Person- Events Total Person- years years years years Total Outcome Code Is the Endpoint a threshold?  Yes (describe)  No Is a higher risk better or worse?  Higher risk is better  Higher risk is worse Follow-up time  Days: ______ Weeks: ______ Months: ______ Years: ______Effect estimates  Reported  Not reported → skip to next outcome Effect measure  RR  OR  HR  ARR/RD Effect estimates Point estimate (95% CI) Unadjusted analyses Adjusted analyses Group 1 vs. Group 2 Group 1 vs. Group 3 Group 1 vs. Control Arm Group 2 vs. Group 3 Group 2 vs. Control Arm Group 3 vs. Control Arm

13 150. Continuous Score Outcome Tx Group 1 Tx Group 2 Tx Group 3 Control Arm  Reported  Not reported → skip this table Unit of measure  Unitless  Specific unit of measure: ______Measure of central  Mean  Median  Mode tendency Measure of variance Unit of variance measure  SD  SE  95%  IQR  range CI Outcome Code Is a higher score better or  Higher score is better  Higher score is worse worse? Follow-up time  Days:  Weeks:  Months:  Years: ______Number of patients available for analysis

Comment – Form VI