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Хирургическое лечение эмпиемы плевры в сравнении с нехирургическим

Appendices

Appendix 1. Glossary of terms

Decortication: surgical removal of fibrous tissue in the pleural space.

Dyspnoea: symptom of breathlessness.

Fibropurulent: also known as fibrinopurulent. It pertains to pus or suppurative exudate that contains a relatively large amount of fibrin.

Intrapleural fibrinolytics: therapy involving administration of fibrinolytics (streptokinase or urokinase) through a chest tube drain to facilitate breakdown of any fibrous loculations and improve the drainage of the pleural collections.

Lactate dehydrogenase (LDH): an enzyme that functions in anaerobic glucose metabolism and glucose synthesis.

Mediastinum: a group of structures in the middle of the thorax, including the heart and its surrounding structures.

Open thoracotomy: surgical procedure to open up the chest cavity (typically a posterolateral incision in an intercostal space), which is widened by rib spreaders (retractors) to gain direct visualisation and access to the pleural space.

Thoracentesis: bedside procedure involving a fine needle (usually 12 to 14 G cannula) connected to a syringe that is inserted into the pleural space to drain any fluid for therapeutic or diagnostic purposes.

Thoracostomy: bedside procedure involving a small incision between two ribs and the insertion of a flexible plastic tube into the pleural space to drain pleural collections.

Video‐assisted thoracoscopic surgery (VATS): surgical procedure involving the insertion of a small video camera along with other surgical instruments through three to four small incision ports into the patient's chest, enabling the chest cavity to be visualised for the performance of surgical procedures.

Appendix 2. MEDLINE search strategy

MEDLINE (Ovid)

1 empyema/ or empyema, pleural/ (5754)
2 Pleural Effusion/ (13675)
3 empyema*.tw. (7147)
4 (pleur* adj3 (effus* or exud* or purulent* or suppurat* or pus)).tw. (18190)
5 pyothora*.tw. (539)
6 ((parapneumon* or para‐pneumon* or para pneumon*) adj3 effus*).tw. (530)
7 or/1‐6 (32019)

We combined the MEDLINE search strategy with the Cochrane Highly Sensitive Search Strategy for identifying randomised trials in MEDLINE (Lefebvre 2011).

Appendix 3. Embase (Elsevier) search strategy

#9 #7 AND #8 1572
#8 798343
#8.8 #8.3 NOT #8.7 798343
#8.7 #8.4 NOT #8.6
#8.6 #8.4 AND #8.5
#8.5 'human'/de
#8.4 'animal'/de OR 'nonhuman'/de OR 'animal experiment'/de
#8.3 #8.1 OR #8.2
#8.2 random*:ab,ti OR placebo*:ab,ti OR crossover*:ab,ti OR 'cross over':ab,ti OR allocat*:ab,ti OR trial:ti OR (doubl* NEXT/1 blind*):ab,ti
#8.1 'randomized controlled trial'/exp OR 'single blind procedure'/exp OR 'double blind procedure'/exp OR 'crossover procedure'/exp
#7 #1 OR #2 OR #3 OR #4 OR #5 OR #6 37679
#6 ((parapneumon* OR 'para‐pneumonia' OR 'para pneumonia') NEAR/3 effus*):ab,ti 650
#5 pyothora*:ab,ti 398
#4 (pleur* NEAR/3 (effus* OR exud* OR purulent* OR suppurat* OR pus)):ab,ti 18502
#3 empyema*:ab,ti 6015
#2 'pleura effusion'/de 26464
#1 'empyema'/de OR 'pleura empyema'/de 6876

Appendix 4. CINAHL (Ebsco) search strategy

S18 S7 AND S17 143
S17 S8 OR S9 OR S10 OR S11 OR S12 OR S13 OR S14 OR S15 OR S16 194,657
S16 (MH "Quantitative Studies") 8,886
S15 TI placebo* OR AB placebo* 20,650
S14 (MH "Placebos") 6,726
S13 (MH "Random Assignment") 29,577
S12 TI random* OR AB random* 103,219
S11 TI ( (singl* or doubl* or tripl* or trebl*) W1 (blind* or mask*) ) OR AB ( (singl* or doubl* or tripl* or trebl*) W1 (blind* or mask*) ) 14,983
S10 TI clinic* trial* OR AB clinic* trial* 31,567
S9 PT 50,578
S8 (MH "Clinical Trials+") 116,013
S7 S1 OR S2 OR S3 OR S4 OR S5 OR S6 1,693
S6 TI ( (parapneumon* or para‐pneumon* or para pneumon*) N3 effus* ) OR AB ( (parapneumon* or para‐pneumon* or para pneumon*) N3 effus* ) 54
S5 TI pyothora* OR AB pyothora* 5
S4 TI ( pleur* N3 (effus* or exud* or purulent* or suppurat* or pus) ) OR
AB ( pleur* N3 (effus* or exud* or purulent* or suppurat* or pus) ) 974
S3 TI empyema* OR AB empyema* 311
S2 (MH "Pleural Effusion") 943
S1 (MH "Empyema") 267

Appendix 5. LILACS (BIREME) search strategy

mh:empyema OR empiema OR mh:"Empyema, Pleural" OR pyothorax OR piotórax OR mh:"Pleural Effusion" OR "Derrame Pleural" OR "pleural effusion" OR "empyema thoracis" OR "para‐pneumonic effusion" OR "para‐pneumonic effusions" AND db:("LILACS") AND type_of_study:("clinical_trials")

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 1 Mortality.
Figuras y tablas -
Analysis 1.1

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 1 Mortality.

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 2 Length of hospital stay (days).
Figuras y tablas -
Analysis 1.2

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 2 Length of hospital stay (days).

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 3 Procedural complications.
Figuras y tablas -
Analysis 1.3

Comparison 1 Open thoracotomy versus thoracostomy drainage, Outcome 3 Procedural complications.

Comparison 2 VATS versus thoracostomy drainage, Outcome 1 Mortality.
Figuras y tablas -
Analysis 2.1

Comparison 2 VATS versus thoracostomy drainage, Outcome 1 Mortality.

Comparison 2 VATS versus thoracostomy drainage, Outcome 2 Length of hospital stay (days).
Figuras y tablas -
Analysis 2.2

Comparison 2 VATS versus thoracostomy drainage, Outcome 2 Length of hospital stay (days).

Comparison 2 VATS versus thoracostomy drainage, Outcome 3 Procedural complications.
Figuras y tablas -
Analysis 2.3

Comparison 2 VATS versus thoracostomy drainage, Outcome 3 Procedural complications.

Summary of findings for the main comparison. Open thoracotomy compared to thoracostomy drainage for pleural empyema

Open thoracotomy compared to thoracostomy drainage for pleural empyema

Patient or population: children with pleural empyema
Intervention: open thoracotomy
Comparison: thoracostomy drainage

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Thoracostomy drainage

Open thoracotomy

Mortality

Follow‐up: up to 3 months after discharge

Risk in study population

Not estimable

30
(1 RCT)

⊕⊕⊕⊝
MODERATE 1

No deaths occurred in either group.

Length of hospital stay (days)

Follow‐up: up to 3 months after discharge

The mean length of hospital stay in the control group was 15.4 days.

The mean length of hospital stay in the intervention group was 5.9 days fewer (7.29 fewer to 4.51 fewer).

30
(1 RCT)

⊕⊕⊕⊝
MODERATE1

Procedural complications

Follow‐up: up to 3 months after discharge

Risk in study population

OR 0.10
(0.02 to 0.63)

30
(1 RCT)

⊕⊕⊕⊝
MODERATE 1

600 per 1000

130 per 1000
(29 to 486)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; OR: odds ratio; RCT: randomised controlled trial

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect.
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

1Downgraded one level due to small sample size and only one study.

Figuras y tablas -
Summary of findings for the main comparison. Open thoracotomy compared to thoracostomy drainage for pleural empyema
Summary of findings 2. VATS compared to thoracostomy drainage for pleural empyema

VATS compared to thoracostomy drainage for pleural empyema

Patient or population: children and adults with pleural empyema
Intervention: VATS
Comparison: thoracostomy drainage

Outcomes

Anticipated absolute effects* (95% CI)

Relative effect
(95% CI)

№ of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Thoracostomy drainage

VATS

Mortality

Risk in study population

OR 0.80
(0.04 to 14.89)

361
(7 RCTs)

⊕⊕⊝⊝
LOW1

Data only for adults

6 per 1000

5 per 1000
(0 to 78)

Mortality: children

Risk in study population

Not estimable

271
(5 RCTs)

⊕⊕⊕⊝
MODERATE 2

No deaths occurred in either group.

Not pooled

Not pooled

Mortality: adults

Follow‐up: not reported

Risk in study population

OR 0.80
(0.04 to 14.89)

90
(2 RCTs)

⊕⊕⊕⊝
MODERATE 3

No deaths occurred in Bilgin 2006. Data based on Wait 1997

23 per 1000

18 per 1000
(1 to 257)

Length of hospital stay (days)

Follow‐up: 1 year in Cobanoglu 2011 and 3 months in Marhuenda 2014

Control group

The mean length of hospital stay in the intervention group was 2.52 days fewer (4.26 fewer to 0.77 fewer).

231
(5 RCTs)

⊕⊕⊕⊝
MODERATE4

Note: Follow‐up period not reported in Kurt 2006; Peter 2009; Wait 1997.

Procedural complications

Follow‐up: 6 months in Bilgin 2006 and not reported in Wait 1997

Risk in study population

OR 0.46
(0.08 to 2.75)

271
(5 RCTs)

⊕⊕⊕⊝
MODERATE 5

23 per 1000

11 per 1000
(2 to 60)

*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: confidence interval; OR: odds ratio; RCT: randomised controlled trial; VATS: video‐assisted thoracoscopic surgery

GRADE Working Group grades of evidence
High quality: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect.
Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

1Downgraded two levels due to wide confidence intervals (data from only one study) and indirectness (data only available for adults).
2Downgraded one level as data not available due to small sample size and no events occurring in the studies.
3Downgraded one level due to small sample size (imprecision) as data available from only one study.
4Downgraded one level due to heterogeneity.
5Downgraded one level due to wide confidence intervals.

Figuras y tablas -
Summary of findings 2. VATS compared to thoracostomy drainage for pleural empyema
Table 1. Total cost of treatment

Trial

Total treatment cost (USD):
thoracostomy arm

Total treatment cost (USD):
VATS arm

P value

Cobanoglu 2011

Mean 386.672 ± 72.06

Mean 957.487 ± 137.238

< 0.001

Kurt 2006

Median (IQR) 21,947 (17,895 to 37,458)

Median (IQR) 19,714 (17,325 to 23,000)

0.315

Sonnappa 2006

Mean 9127

Mean 11,379

< 0.001

Peter 2009

Mean 7600 ± 5400

Mean 11,700 ± 2900

0.02

Wait 1997

Mean 24,052 ± 3466

Mean 16,642 ± 2841

0.11

IQR: interquartile range

Figuras y tablas -
Table 1. Total cost of treatment
Table 2. Duration of chest tube drainage

Trial

Duration of chest tube
drainage: thoracostomy arm (days)

Duration of chest tube drainage:
surgical arm (days)

P value

Cobanoglu 2011

Mean 9.48 ± 2.50

Mean 6.56 ± 1.55

< 0.001

Karaman 2004

Mean 13.8 ± 2.3

Mean 7.5 ± 1.1

< 0.05

Kurt 2006

Mean 9.63 ± 5.45

Mean 2.80 ± 0.63

< 0.001

Marhuenda 2014

Median (IQR) 5 (4 to 6)

Median (IQR) 4 (3 to 5)

< 0.001

Wait 1997

Mean 9.8 ± 1.3

Mean 5.8 ± 1.1

0.03

IQR: interquartile range

Figuras y tablas -
Table 2. Duration of chest tube drainage
Table 3. Postintervention fever duration

Trial

Postintervention fever duration:
thoracostomy arm (days)

Postintervention fever
duration: surgical arm (days)

P value

Cobanoglu 2011

Mean 3.9 ± 2.1

Mean 3.4 ± 2.4

0.782

Kurt 2006

Mean 6.25 ± 4.10

Mean 3.60 ± 2.95

0.146

Marhuenda 2014

Median (IQR) 6 (3 to 7)

Median (IQR) 4 (2 to 7)

0.62

Sonnappa 2006

Median (range) 2.5 (0 to 25)

Median (range) 2.5 (0 to 10)

0.635

Peter 2009

Mean 3.8 ± 2.9

Mean 3.1 ± 2.7

0.46

IQR: interquartile range

Figuras y tablas -
Table 3. Postintervention fever duration
Comparison 1. Open thoracotomy versus thoracostomy drainage

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

1

30

Odds Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

2 Length of hospital stay (days) Show forest plot

1

30

Mean Difference (IV, Random, 95% CI)

‐5.9 [‐7.29, ‐4.51]

3 Procedural complications Show forest plot

1

30

Odds Ratio (M‐H, Random, 95% CI)

0.10 [0.02, 0.63]

Figuras y tablas -
Comparison 1. Open thoracotomy versus thoracostomy drainage
Comparison 2. VATS versus thoracostomy drainage

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Mortality Show forest plot

7

361

Odds Ratio (M‐H, Random, 95% CI)

0.8 [0.04, 14.89]

1.1 Children

5

271

Odds Ratio (M‐H, Random, 95% CI)

0.0 [0.0, 0.0]

1.2 Adults

2

90

Odds Ratio (M‐H, Random, 95% CI)

0.8 [0.04, 14.89]

2 Length of hospital stay (days) Show forest plot

5

231

Mean Difference (IV, Random, 95% CI)

‐2.52 [‐4.26, ‐0.77]

2.1 Children

4

211

Mean Difference (IV, Random, 95% CI)

‐1.99 [‐4.36, 0.39]

2.2 Adults

1

20

Mean Difference (IV, Random, 95% CI)

‐4.10 [‐4.99, ‐3.21]

3 Procedural complications Show forest plot

5

271

Odds Ratio (M‐H, Random, 95% CI)

0.46 [0.08, 2.75]

3.1 Children

3

181

Odds Ratio (M‐H, Random, 95% CI)

0.94 [0.06, 15.48]

3.2 Adults

2

90

Odds Ratio (M‐H, Random, 95% CI)

0.28 [0.03, 2.88]

Figuras y tablas -
Comparison 2. VATS versus thoracostomy drainage