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Supplemental material, sj-docx-1-inc-10.1177_17511437231169193 for biomArker-guided Duration of Antibiotic treatment in hospitalised Patients with suspecTed Sepsis (ADAPT-Sepsis): A protocol for a multicentre randomised controlled trial by Paul Dark, Gavin D Perkins, Ronan McMullan, Danny McAuley, Anthony C Gordon, Jonathan Clayton, Dipesh Mistry, Keith Young, Scott Regan, Nicola McGowan, Matt Stevenson, Simon Gates, Gordon L Carlson, Tim Walsh, Nazir I Lone, Paul R Mouncey, Mervyn Singer, Peter Wilson, Tim Felton, Kay Marshall, Anower M. Hossain and Ranjit Lall in Journal of the Intensive Care Society

Supplemental material, sj-docx-2-inc-10.1177_17511437231169193 for biomArker-guided Duration of Antibiotic treatment in hospitalised Patients with suspecTed Sepsis (ADAPT-Sepsis): A protocol for a multicentre randomised controlled trial by Paul Dark, Gavin D Perkins, Ronan McMullan, Danny McAuley, Anthony C Gordon, Jonathan Clayton, Dipesh Mistry, Keith Young, Scott Regan, Nicola McGowan, Matt Stevenson, Simon Gates, Gordon L Carlson, Tim Walsh, Nazir I Lone, Paul R Mouncey, Mervyn Singer, Peter Wilson, Tim Felton, Kay Marshall, Anower M. Hossain and Ranjit Lall in Journal of the Intensive Care Society

Supplemental material, sj-docx-2-inc-10.1177_17511437231169193 for biomArker-guided Duration of Antibiotic treatment in hospitalised Patients with suspecTed Sepsis (ADAPT-Sepsis): A protocol for a multicentre randomised controlled trial by Paul Dark, Gavin D Perkins, Ronan McMullan, Danny McAuley, Anthony C Gordon, Jonathan Clayton, Dipesh Mistry, Keith Young, Scott Regan, Nicola McGowan, Matt Stevenson, Simon Gates, Gordon L Carlson, Tim Walsh, Nazir I Lone, Paul R Mouncey, Mervyn Singer, Peter Wilson, Tim Felton, Kay Marshall, Anower M. Hossain and Ranjit Lall in Journal of the Intensive Care Society

ImportanceOpioid use for chronic nonmalignant pain can be harmful.ObjectiveTo test whether a multicomponent, group-based, self-management intervention reduced opioid use and improved pain-related disability compared with usual care.Design, Setting, and ParticipantsMulticentered, randomized clinical trial of 608 adults taking strong opioids (buprenorphine, dipipanone, morphine, diamorphine, fentanyl, hydromorphone, methadone, oxycodone, papaveretum, pentazocine, pethidine, tapentadol, and tramadol) to treat chronic nonmalignant pain. The study was conducted in 191 primary care centers in England between May 17, 2017, and January 30, 2019. Final follow-up occurred March 18, 2020.InterventionParticipants were randomized 1:1 to either usual care or 3-day–long group sessions that emphasized skill-based learning and education, supplemented by 1-on-1 support delivered by a nurse and lay person for 12 months.Main Outcomes and MeasuresThe 2 primary outcomes were Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS-PI-SF-8a) score (T-score range, 40.7-77; 77 indicates worst pain interference; minimal clinically important difference, 3.5) and the proportion of participants who discontinued opioids at 12 months, measured by self-report.ResultsOf 608 participants randomized (mean age, 61 years; 362 female [60%]; median daily morphine equivalent dose, 46 mg [IQR, 25 to 79]), 440 (72%) completed 12-month follow-up. There was no statistically significant difference in PROMIS-PI-SF-8a scores between the 2 groups at 12-month follow-up (−4.1 in the intervention and −3.17 in the usual care groups; between-group difference: mean difference, −0.52 [95% CI, −1.94 to 0.89]; P = .15). At 12 months, opioid discontinuation occurred in 65 of 225 participants (29%) in the intervention group and 15 of 208 participants (7%) in the usual care group (odds ratio, 5.55 [95% CI, 2.80 to 10.99]; absolute difference, 21.7% [95% CI, 14.8% to 28.6%]; P Conclusions and RelevanceIn people with chronic pain due to nonmalignant causes, compared with usual care, a group-based educational intervention that included group and individual support and skill-based learning significantly reduced patient-reported use of opioids, but had no effect on perceived pain interference with daily life activities.Trial Registrationisrctn.org Identifier: ISRCTN49470934

Additional file 3: Table S2. Moderator analysis for short-term outcomes (overall comparison).

Additional file 3. Risk of bias assessment within studies included in quantitative synthesis

Additional file 5. 1076 studies were excluded considering the title, while 58 after reading the abstract or full text. The table summarize the reason for exclusion of the 58 papers

Additional file 7. Results of two-stage IPD-MA. Occurrence of reintubation (p value=0.83)

Additional file 2: Table S1. One-step meta-analysis: Estimated difference between control (non-active usual care and sham) and all intervention treatments for each outcome adjusted by its baseline value for short-, mid-, and long-term follow-up.

Additional file 4. Extended methods: secondary outcomes, search strategy, data collection process, and risk of bias (quality) assessment

Additional file 1. Search strategies

Additional file 2. Letters sent to the authors

Additional file 6. Criteria for readiness to wean and spontaneous breathing trails performed before randomization

Additional file 1: Appendix 1. Clinical characteristics at baseline by treatment arms. Data are m, number of trials, and n, number of participants. Appendix 2. Summary of the number of trials (m), number of participants (n) and covariates used to identify subgroup in overall comparison for each short-term outcome with recursive partitioning (RP) and adaptive refinement by directed peeling (ARDP) methods. Appendix 3. Summary of the number of trials (m), number of participants (n) and covariates used to identify subgroup for different pairwise comparisons for each short-term outcome with recursive partitioning (RP) and adaptive refinement by directed peeling (ARDP) methods. Appendix 4. Subgroups identified by the recursive partitioning (RP) method for the passive physical vs non-active usual care comparison. Appendix 5. Subgroups identified by the recursive partitioning (RP) method for the psychological vs non-active usual care comparison. Appendix 6. Subgroups identified by the recursive partitioning (RP) method for the sham vs non-active usual care comparison. Appendix 7. Trajectory plot for the treatment effect against the size of the constructed region for short-term (a) Hannover functional ability questionnaire for measuring back-pain related functional limitations, FFbHR, (b) Roland Morris disability questionnaire, RMDQ, (c) Pain, (d) physical component scale of SF-12/36, (e) mental component scale of SF-12/36, and (f) EQ-5D. The number of trials, m, and number of patients, n, in each of the subgroup identification analyses. Appendix 8. Thresholds for selected sizes of the subgroup for the short-term SF-12/36 MCS as seen in Additional file 1: Appendix 7, figure (e). Appendix 9. Thresholds for selected sizes of the subgroup for the short-term EQ-5D as seen in Additional file 1: Appendix 7, figure (f).