Identification of subgroup effect with an individual participant data meta-analysis of randomised controlled trials of three different types of therapist-delivered care in low back pain

Background: Proven treatments for low back pain, at best, only provide modest overall benefits. Matching people to treatments that are likely to be most effective for them may improve clinical outcomes and makes better use of health care resources. Methods: We conducted an individual participant data meta-analysis of randomised controlled trials of three types of therapist delivered interventions for low back pain (active physical, passive physical and psychological treatments). We applied two statistical methods (recursive partitioning and adaptive risk group refinement) to identify potential subgroups who might gain greater benefits from different treatments from our individual participant data meta-analysis. Results: We pooled data from 19 randomised controlled trials, totalling 9328 participants. There were 5349 (57%) females with similar ratios of females in control and intervention arms. The average age was 49 years (standard deviation, SD, 14). Participants: with greater psychological distress and physical disability gained most benefit in improving on the mental component scale (MCS) of SF-12/36 from passive physical treatment than non-active usual care (treatment effects, 4.3; 95% confidence interval, CI, 3.39 to 5.15). Recursive partitioning method found that participants with worse disability at baseline gained most benefit in improving the disability (Roland Morris Disability Questionnaire) outcome from psychological treatment than non-active usual care (treatment effects, 1.7; 95% CI, 1.1 to 2.31). Adaptive risk group refinement did not find any subgroup that would gain much treatment effect between psychological and non-active usual care. Neither statistical method identified any subgroups who would gain an additional benefit from active physical treatment compared to non-active usual care. Conclusions: Our methodological approaches worked well and may have applicability in other clinical areas. Passive physical treatments were most likely to help people who were younger with higher levels of disability and low levels of psychological distress. Psychological treatments were more likely to help those with severe disability. Despite this, the clinical importance of identifying these subgroups is limited. The sizes of sub-groups more likely to benefit and the additional effect sizes observed are small. Our analyses provide no evidence to support the use of sub-grouping for people with low back pain

sj-docx-2-inc-10.1177_17511437231169193 – Supplemental material for biomArker-guided Duration of Antibiotic treatment in hospitalised Patients with suspecTed Sepsis (ADAPT-Sepsis): A protocol for a multicentre randomised controlled trial

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</p

sj-docx-1-inc-10.1177_17511437231169193 – Supplemental material for biomArker-guided Duration of Antibiotic treatment in hospitalised Patients with suspecTed Sepsis (ADAPT-Sepsis): A protocol for a multicentre randomised controlled trial

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</p