Does ICP-monitor-based management influence outcome in TBI?

Reference	# of Patients	Design	Grade crit.	Results	Caveats
Saul and Ducker, 1982 [37]	233 (106 pre, 127 post)	Single-centre, retrospective, sequential case series’ comparing two protocols	Low	Lower mortality (46 vs. 28 %) associated with a stricter ICP Tx protocol (with lower threshold)	Concomitant change in ICP treatment threshold; many uncontrolled changes associated with protocol
Vukic et al. 1999 [61]	28 (11 pre, 18 post)	Single-centre, prospective, sequential case series comparing no protocol/no monitoring to BTF protocol with ICP monitoring	Low	14 % lower mortality and 50 % more favourable GOS outcome in group managed via monitoring/protocol	Role of ICP monitoring in protocol effects unclear. No statistical analysis
Clayton et al., 2004 [63]	843 (391 pre, 452 post)	Single centre, retrospective, sequential case series examining effect of an ICP management protocol	Low	Reduction in ICU mortality (19.95–13.5 %; OR 0.47; 95 % CI 0.29–0.75), and hospital mortality (24.55–20.8 %; OR 0.48; 95 % CI 0.31–0.74)	Primary change was in CPP management; role of ICP monitoring unclear
Fakhry et al. 2004 [64]	820 (219 preprotocol, 188 low compliance, 423 high compliance)	Single-centre retrospective case series from prospective registry of implementing BTF-based management protocol	Low	No significant change in mortality (17.8, 18.6, 13.7). Compliance-related improvement in discharge GOS 4–5 (43.3, 50.3, 61.5 %) and appropriate response on RLA (43.9, 44.0 %, 56.6 %). Shorter ICU and hospital LOS	No ICP data or analysis of ICP-monitoring-specific effects
Spain et al. 1998 [65]	133 (49 pre, 84 post)	Single-centre prospective case series with clinical pathway versus retrospective control prepathway	Low	Significant improvement in process variables unrelated to ICP monitoring; increase in hospital mortality associated with pathway (12.2–21.4 %) attributable to withdrawal of care. No difference in functional outcome	Strong confounding by general effects of clinical pathway (became point of paper)
Arabi et al. 2010 [66]	434 (74 pre, 362 post)	Single-centre retrospective case series’ from prospective database comparing protocol to pre-protocol period	Low	Protocol use independently associated with reduced hospital mortality (OR 0.45; 95 % CI 0.24–0.86; p = .02) and ICU mortality (OR 0.47; 95 % CI 0.23–0.96; p = .04)	Small, retrospective control group
Haddad et al. 2011 [67]	477	Single-centre retrospective case series from prospective database examining role of ICP in protocol-related improvements	Low	ICP monitoring not associated with significant independent difference in hospital (OR 1.71, 95 % CI 0.79–3.70, p = 0.17) or ICU mortality OR 1.01, 95 % CI 0.41–2.45, p = 0.99)	Associated decrease in ICP monitoring frequency not explained. No control for choice to monitor
Bulger et al. 2002 [68]	182	Multi-centre retrospective cohort study from prospective database examining outcome based on ‘‘aggressiveness’’ of TBI care	Low–Mod	Adjusted hazard ratio for death of 0.43 (95 % CI 0.27–0.66) for management at an ‘‘aggressive’’ center compared to a ‘‘nonaggressive’’ center. No significant difference in discharge functional status of survivors	General trauma database lacked important demographic information. ICP as marker, causality not assessed
Cremer et al. 2005 [69]	333	Two-centre retrospective cohort study comparing a centre monitoring ICP versus on not monitoring ICP	Low–Mod	No difference in hospital mortality for ICP group (33 %) versus noICP group (34 %; p = 0.87). No difference in functional outcome at ≥12 months (OR 0.95; 95 %CI 0.62–1.44)	No description of management approaches. Only 67 % monitored at monitoring centre. Excluded deaths ≤24 h
Lane et al. 2000 [76]	5,507	Multi-centre retrospective cohort study from prospective database examining correlation of ICP monitoring and outcome	Low–Mod	ICP monitoring independently associated with improved survival (p < 0.015)	General trauma database lacked important demographic information. No control for centre differences or choice to monitor
Shafi et al. 2008 [77]	1,646	Multi-centre retrospective cohort study from prospective database examining correlation of ICP monitoring and outcome	Low–Mod	Higher adjusted hospital mortality for monitored patients (OR 0.55; 95 % CI 0.39–0.76; p < 0.001)	General trauma database lacked important demographic information. No control for centre differences or choice to monitor. Excluded deaths ≤48 h
Mauritz et al. 2008 [73]	1,856	Multi-centre retrospective cohort study from prospective database examining correlation of ICP monitoring and outcome	Low	No significant association of ICP monitoring with hospital outcome as a single factor nor in interaction with SAPS II	Significant, unexplained centre differences in ICP monitoring and outcome
Farahvar et al. 2012 [17]	1,446	Multi-centre retrospective cohort study from prospective database examining correlation of ICP monitoring and outcome	Low–Mod	Trend toward reduced 2-week mortality for monitored patients by multivariate logistic regression modeling (OR 0.64; 95 % CI 0.41–1.00; p = 0.05)	No control for decision to monitor or to treat unmonitored patients for intracranial hypertension
Stein et al. 2010 [78]	127 studies containing >125,000 patients	Meta-analysis of mortality data from 127 studies containing ≥90 patients, examining influence of treatment intensity (based on prevalence of ICP monitoring) on 6 month mortality	Low–Mod	‘‘High-intensity’’ treatment associated with a approximately 12 % lower adjusted mortality rate (p < 0.001) and a 6 % higher pooled mean rate of favorable outcomes (p < 0.001)	Did not access original data. Ad hoc definition of and threshold for treatment intensity
Chesnut et al. 2012 [79]	324	RCT comparing BTF-based protocol based on ICP monitoring to protocol based on imaging and clinical exam without monitoring	Mod–high	Primary outcome = no significant difference in 6-month composite outcome measure (OR 1.09; 95 % CI 0.74–1.58; p = 0.49). Secondary outcome = no significant difference in 14 day mortality (OR 1.36; 95 % CI 0.87–2.11; p = 0.18), cumulative 6-month mortality OR 1.10; 95 % CI 0.77–1.57; p = 0.60), or 6-month GOS-E (OR 1.23; 95 % CI 0.77–1.96)	Generalizability limited by issues surrounding prehospital care, choice of primary outcome measure, and management protocols
Smith et al. 1986 [80]	77	Prospective randomized trial of patients treated based on ICP versus scheduled treatment	Low	No significant difference in 1 year GOS by univariate analysis. Mean ICP 5.5 mmHg higher in monitor-based-treatment group	Small sample size. Investigation not designed to study ICP monitor utility