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Table 2 Published studies  depicted in Fig. 1 and the postulated SHEET described in the text

From: Establishing the safety of selective digestive decontamination within the ICU population: a bridge too far?

Author, year

Figure 1 symbol

Patients (n)/ICUs

(N)a

Time periods

Mo, months; w, weeks

Intervention

Mortality effect sizeb,c,d

ICC

Informed consent

Community CRTs

 Sur, 2009 [72]

 

60,000/40

24 mo

Typhoid vs hepatitis vaccination

NR

NR

Fever clinic attendees

 Ali, 2005 [75] 

 

74,003/[5 strata]

12 mo

OCV vs placebo vaccine

NR

NR

Post hoc re-analysis of RCCT data

 MORDOR, 2018 [73, 74]

 

190,238/1533

24 mo

Azithromycin vs placebo

IRR 0.82; 0.74–0.90

NR

Oral or written

ICU CRTs

 De Smet, 2009c  [44]

d

5939/13

6 mo × 3 crossover

SDD vs SC

OR; 0.91; 0.79–1.06

Adj OR; 0.81; 0.64–0.94

0.05

Waived

 Oostdijk, 2014c [45]

o

11,997/16

12 mo × 2 crossover

SDD vs SOD

OR; 0.94; 0.82–1.05

Adj OR; 0.87; 0.71–0.99

0.05

Waived

 Wittekamp, 2018d [46]

w

8665/13

6 mo × 4 crossover

SDD vs SC

Adj HR; 0.95; 0.81–1.11

0.001

Waived

 CHORAL, 2021f [69]

c

3260/6

2 mo × 6 steps; Step wedge

SC vs CHLX

OR; 1.13; 0.82–1.54

0.001

Waived

 SuDDICU, 2022 g [47]

s

5982/19

12 mo × 2 crossover

SDD vs SC

OR; 0.92; 0.79–1.08

0.01

Waived

 SHEET (as postulated)h

 

15,600/104

12 mo × 2 crossover

SDD vs SC

TBD

0.001

TBD

  1. CHLX Topical chlorhexidine, SC Standard care, SDD Selective digestive decontamination, NR Not reported, NA Not applicable, RR Risk ratio, IRR Incidence rate ratio, OR Odds ratio, RD Risk difference, Adj Adjusted, TAP Topical antibiotic prophylaxis, PPAP Protocolized parenteral antibiotic prophylaxis, AS Antiseptic, OCV Oral cholera vaccine, TBD To be determined
  2. aThese numbers (‘n’ = number of patients, and ‘N’ = number of clusters or studies) are for the whole study or systematic review, which in some cases include arms which are not shown here
  3. bMortality end-point is ICU mortality in all cases except MORDOR [73, 74] which is annual mortality. The study by Sur did not report mortality
  4. cAdjusted analyses. 28-day mortality effect sizes from a random-effects logistic-regression model adjusted for age, sex, illness severity score and several other variables
  5. dAdjusted analyses. The hazard ratio was estimated in analyses adjusted for age, sex, illness severity score and several other variables
  6. eThe following study arms are not shown here; de Smet study [44] also included SOD (Selective oropharyngeal decontamination) as a third arm versus standard care and the Wittekamp study [46] included SOD intervention as a fourth arm versus chlorhexidine bodywashings and a hand hygiene improvement program as the standard care arm
  7. fThe CHORAL study [69] evaluated the de-adoption of topical chlorhexidine. Note that the control group received topical chlorhexidine and the intervention group did not
  8. gThe ecological study within the SuDDICU study [47] is not shown here
  9. hThe RCCT within the postulated SHEET study is not shown here
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