Study reference

Study characteristics

Patient characteristics

Intervention (I)

Comparison / control (C)

Follow-up

Outcome measures and effect size

Comments

Boshuizen, 2017

Type of study:

RCT

Setting: multicenter

Country: the Netherlands

Source of funding:

Nuts-OHRA foundation and the Dutch Cancer Society. Materials were provided by Rocket Medical. This latter company had no role in the design of the study.

Inclusion criteria:

- patients with histologically or cytologically confirmed MPE.

- patients with a progressive malignancy and pleural effusion after exclusion of alternative diagnoses.

Exclusion criteria

- previous treatment with either talc pleurodesis or indwelling pleural catheter for ipsilateral MPE.

- impaired immunity or thrombocytopenia.

N total at baseline

Intervention: 48

Control: 46

Important prognostic factors:

Median age (range):

I: 60 (35-81)

C:64 (30-84)

Sex:

I: 56% M

C: 41% M

Diagnosis:

I:lung 33%, breast 21%

C:lung 33%, breast 22%

Groups comparable at baseline? There were less females in the intervention groups.

Talc pleurodesis. Patients were admitted to the hospital.

Indwelling pleural catheter, inserted on an outpatient basis. Instruction to drain on as-needed basis.

6 weeks, 3 and 6 months. The Modified Borg Scale scores were assessed daily in the first two weeks after randomization.

Registration: n=154

Randomized: n=94

Reasons for loss-to-follow-up according to the consort diagram for the per protocol analysis (talk pleurodeses: n=13 evaluable, IPC: n=18 evaluable).

I: n=35 (72%), reasons:

• Died within 6 weeks (n=19)
• Re-intervention (n=6)
• No or incomplete treatment (n=6)
• IPC (n=1)
• No returned PRO (n=3)

C: n=28 (61%), reasons:

• Died within 6 weeks (n=16)
• Re-intervention (n=4)
• No/incomplete treatment (n=2)
• TP (n=1)
• No returned PRO (n=5)

40 patients were evaluable in de intention to treat analysis (20:20). Per protocol analysis: excludes patients who had no talk instilled or underwent an ipsilateral re-intervention within 6 weeks.

1. Quality of life

Not reported

2. Dyspnea

Modified Borg Scale at rest at 6 weeks

I: 2.2

C:1.6

P=0.25

Modified Borg Scale during exercise at 6 weeks

I: 2.1

C:1.8

P=0.44

“improvement in dyspnea wasn’t different between both treatments at 3 and 6 months”

3. Length of hospital admission

Defined as length of hospital admission during randomized treatment

I: 4

C:0

P<0.0001

Defined as length of total hospitalization

I: 6

C:3

P<0.002

4. Costs

Not reported

5. Adverse events

I: Pain (1), dyspnea (2), infection (2), cardiovascular events (1), general malaise (1)

C: Pain (2), dyspnea (3), infection (2), cardiovascular events (1), general malaise (0).

There were no differences between the groups.

6. Re-interventions

Defined as the mean number of re-interventions, per patient

I: 0.5

C:0.2

P<0.05

Defined as the number of patients with >1 re-intervention

I:15/45

C:7/46

P=0.09

At registration patients were treated with therapeutic thoracentesis. Patients were randomized when fluid recurred within 6 months.

No significant difference between adverse events in the groups were found, but the numbers are very small.

Quality of life among the outcome measures in the trial register, results published.

Demmy, 2012

Type of study: RCT

Setting: multicenter

Country: USA

Source of funding: NCI. The authors have disclosed that they have no financial relationships.

Inclusion criteria:

• Symptomatic patients with malignancy proven by histology or cytology
• Evidence of previously untreated unilateral pleural effusion requiring pleurodesis or ongoing drainage on chest roentgenogram
• ECOG performance status 0-2
• no active pleural infection, talc allergy or other contraindication to talc use.

Exclusion criteria:

• Suspicion of trapped lung
• Anticipated survival <60 days
• Severe comorbid medical conditions

N total at baseline:

Intervention: 33, 28 included in the analyses.

Control: 34, 29 included in the analyses

Important prognostic factors:

age ± SD:

I: 64±NR

C:60±NR

Sex:

I: 61% M

C: 55% M

Diagnosis:

I:lung 68%, breast 11%

C:lung 59%, breast 4%

Groups comparable at baseline? Yes

PleurX Catheter, daily drainage.

Talc pleurodesis.

Length of follow-up: 30 and 60 days

Loss-to-follow-up:

Intervention:5 (15%)

Reasons: not clear

Control: 5 (15%)

Reasons: not clear

In the text it is stated that nine patients were excluded from analysis (n=6 bilateral effusions, n=3 did not start protocol treatment due to other disease complications). However according to figure 1, 10 patients were excluded.

Incomplete outcome data:

See loss-to-follow-up section

1. Quality of life

Data was not reported

2. Dyspnea

I: 8.5

C: 6.1

P=0.047. Analysis adjusted for baseline dyspnea score, initial drainage, gender, inpatient status and patients performance status at baseline.

3. Length of hospital admission

Not reported

4. Costs

Not reported

5. Adverse events

I: one acute respiratory distress syndrome related death (n=1), myocardial infarction (n=1), pain (n=3), leucocytosis (n=1), wound infection (n=1), neutropenia (n=1)

C: fatigue (n=1), dyspnea (n=2, one grade 4).

6. Re-interventions

Defined as the number of patients alive without effusion recurrences within 30 days, n(%)

I: 23 (82)

C: 15 (52)

P=0.0239

Due to slow accrual, the study was closed early. The original aim was to include 530 patients. Patients refused to be randomized.

Not all patients received the allocated therapy:

• Loculation: 1 in C, 2 in I
• Failed lung expansion: 2 in C, 0 in I
• Chest tube/catheter occlusion: 1 each

Davies, 2012;

Penz, 2014

Olfert, 2017

Type of study: RCT, cost-effectiveness study

Setting: multicenter

Country: England

Source of funding: six of the authors of the publication by Davies, 2012 had relations with the pharmaceutical industry. The study was supported by non-commercial grants, the IPC and drainage bottles were provided by Rocket Medical.

Inclusion criteria:

• Adults
• Diagnosis of symptomatic malignant pleural effusion requiring pleurodesis

Exclusion criteria:

• Age<18 years
• Expected survival <3 months
• Chylothorax
• Previous lobectomy or pneumonectomy on the side of the effusion
• Previous attempted pleurodesis
• Pleural infection
• Total white blood cell count <1000/µL
• hypercapnic ventilator failure
• Pregnancy
• Lactating mothers
• Irreversible bleeding diathesis
• Irreversible visual impairment

N total at baseline:

Intervention: 52

Control: 54

Important prognostic factors:

For example

age ± SD:

I: 67 ± 11

C: 67 ± 12

Sex:

I: 44% M

C:43% M

Cancer diagnosis:

I: 31%breast, 17% lung

C: 20% breast, 30% lung

Groups comparable at baseline? Yes, although there were some small differences between the groups in dyspnea (I:62, C:55), chest pain (I:29, C:22) and diagnosis.

Placement of an indwelling pleural catheter, initial large volume drainage and home drainage. The advice was to drain 3x per week, or as required.

Talc slurry pleurodesis

Patients with trapped lung (<50% of lung surface in apposition of the chest wall) did not undergo treatment, but remained in the study.

Length of follow-up:

12 months. Median survival was 200 days in the control group and 153 in the intervention group.

Loss-to-follow-up:

5 patients in the intervention group and 15 patients in the control group died during the first 42 days. 86 patients were alive at 6 weeks follow-up, 69 at 3 months and 54 at 6 months.

Incomplete outcome data:

For the primary outcome (VAS dyspnea) in the first 42 days

Intervention: n=3 (5.8%)

Reasons: no recorded VAS scores

Control: n=7 (12.9%)

Reasons: no recorded VAS scores

The VAS scores for dyspnea was available for 62 patients at 6 weeks, 57 at 3 months and 43 at six months

Data concerning the length of hospital admission was available for

I: 51 patients (n=1 lack of information)

C: 48 patients (n=3 lack of information, n=3 died while being hospitalized_

Data concerning QOL was available in 69 patients at 6 weeks, 56 at 3 months and 41 at 6 months.

Costs data were missing for 10 patients (18.5%) in the control group and 23 patients (44%) in the intervention group.

EQ-5D-3L utility scores were missing in:

I:

Baseline: 2%

14 weeks:11%

26 weeks:24%

1 year:28%

C:

Baseline: 2%

14 weeks:22%

26 weeks:25%

1 year:41%

All analyses were adjusted for performance status and mesothelioma.

1. Quality of life

Assessed using the EORTC QLQ-C30 global health status scale, mean (SD), at 6 weeks:

I: 59.0 (95%CI=51.8;66.3)

C: 48.3 (95%CI=50.1;56.5)

Difference: 4.8 (95%CI=-1.6;11.2, p=0.14)

“there was no significant difference in the quality of life at any time point”

2. Dyspnea

Assessed using a 100 mm VAS. 0= no breathlessness, 100=maximal breathlessness

First 42 days, mean:

I: 24.7 (95%CI=19.3-30.1)

C: 24.4 (95%CI=19.4-29.4)

Difference, also adjusted for baseline VAS: 0.16 (95%CI=-6.82;7.15, p=0.96).

Difference at 3 months: -8.9 (95%CI=1.7;-19.4)

Difference at 6 months: -14.0 (95%CI=-25.2;-2.8)

3. Length of hospital admission

Measured as the nights spend in the hospital from randomisation to discharge, median (OQR)

I: 0 (0;1)

C: 4 (2;6)

Difference: -3.5 (95%CI:-4.8;-. 1.5, p<0.001)

Measured as the length of the hospital admission for

 drainage or drain related complications over 12 months, median (QOR):

I: 1 (0;3)

C: 4.5 (2.5;7.5)

Difference: p<0.01

4. Costs

Total mean costs (SD):

I: $4993 (5529)

C:$4581 (4359)

Difference: +$401 (95%CI=-1387;2261)

Mean costs for patients who survived >14 weeks:

I: $5705 (1122)

C:$4625 (1085)

Difference: +$1098 (95%CI=-1418;4010)

Mean costs for patients who survived <14 weeks:

I: $2944 (656)

C:$4671 (642)

Difference: -$1719 (95%CI=-3376;-85)

If it is assumed that IPC requires 2h nursing care per week, the costs are:

I: $6807 (6225)

C:$4638 (4411)

Difference: +$2130 (95%CI=-205;4184)

Cost-effectiveness

Utility scores

Baseline, mean (SD):

I: 0.59 (0.17)

C: 0.61 (0.17)

P=0.65

Follow-up, mean (SD):

I: 0.79 (0.16)

C: 0.67 (0.32)

P=0.30

1 year, mean QUALY gained (SD):

I: 0.35 (0.296)

C: 0.33 (0.303)

Difference: 0.026 (95%CI:-0.09;0.13), p=0.64

Mean ICER for IPC: $10870/QUALY

Survival <14 weeks

QUALY gained

I: 0.064 (0.052)

C: 0.04 (0.039)

Difference: 0.024 (95%CI:-0.005;0.05), p=0.13

Mean ICER for IPC: $ -79303/QUALY

Survival >14 weeks

QUALY gained

I: 0.495 (0.261)

C: 0.539 (0.226)

Difference: 0.044 (95%CI:-0.159;0.076), p=0.48

Mean ICER for IPC: $ -22299/QUALY

Nursing care 2 h per week

I: 0.354 (0.296)

C: 0.328 (0.303)

Difference: 0.026 (95%CI:-0.085;0.134), p=0.64

Mean ICER for IPC: $ 77213/QUALY

5. Adverse events

Measured as the number of patients with AE’s

I: 21 (40%)

C: 7 (13%)

OR=4.7, 95%CI=1.75;12.6, p=0.002

Number of patients with SAE’s

I: 9 (17%)

C: 5 (9%)

OR=2.1, 95%CI=0.57;7.71, p=0.26

Serious pleural infections

I: n=5

C: n=1

Serious cellulitis

I: 1

C: 0

Chest pain requiring admission

I: 1

C: 0

Symptomatic fluid loculation requiring fibronolytics

I: 1

C: 1

Catheter blockage:

I: 1

C:1

Other:

I:0

C:2

6. Re-interventions

Defined as the further pleural procedures:

I: n=3 (6%)

C: n=12 (22%)

OR =0.21 (95%CI=0.04;0.86, p=0.03)

Outcomes on the VAS scales were analysed using a mixed-effects linear regression model.

Costs (Penz, 2014)

Costs were calculated from a health-care payer perspective. The following categories were included: initial intervention procedures and hospital length of stay, resources related to ongoing drainage, and adverse events. Costs were inflated to 2013 values.

Missing data was imputed.

Cost-effectiveness (Olfert, 2017)

Cost-effective analysis was performed from a healthcare payer perspective using costs and utility scores derived from the EQ-5D-3L data. QUALYs were determined using the survival and utility scores. Costs were inflated to 2014 values.

Cost-effectiveness = difference in costs between the groups/difference in QUALYs between the groups. A willingness to pay threshold of $50000 was used.

There seems a small error in the article: the mean QLQ-C30 score for the control condition is situated the 95%CI.

Putman, 1999

Type of study: RCT

Setting: multicenter

Country: USA

Source of funding: Denver Biomaterials

Inclusion criteria:

• Malignancy
• At least moderate sized pleural effusion
• Relieve of dyspnea after thoracentesis.

Exclusion criteria:

• Chylothorax
• Previous lobectomy or pneumonectomy on the affected side
• Previous pleurodesis attempts
• Autoimmunodeficiency syndrome
• Karnofsky performance status score < 50
• Bilateral moderate or larger pleural effusions
• Multiple loculations
• Mediastinal shift toward the side of the effusion
• Pleural infection
• Abnormal coagulation profile

Patients could receive systemic chemotherapy or mediastinal radiation, but no intrapleural chemotherapy or radiation therapy to the ipsilateral chest.

N total at baseline:

Intervention: 99

Control: 45

Important prognostic factors:

age ± SD:

I: 60.3 ±13.6

C:63.4±13.6

Sex:

I: 42% M

C:42% M

Cancer diagnosis:

I: lung: 39%, breast: 25%

C:lung: 42%, breast: 31%

Groups comparable at baseline? Yes, although there were more right-sided effusions (61% vs 39%) in the intervention group and the initial size of the effusion was larger in the intervention group (p=0.031)

Placement of an Indwelling pleural catheter and initial drainage of 1500mL. Hereafter 1000mL was drained every 8h until drainage was completed. Patients were instructed to perform the drainage every other day.

Doxycycline pleurodesis via tube thoracostomy

Length of follow-up: 12 weeks. Median survival was 90 days for the patients in the control group and 87 days in de intervention group.

Loss-to-follow-up:

Intervention: 5 patients were withdrawn after randomisation.

Reasons: Radiographs were misinterpreted (n=2), loculated effusion (n=1), protocol violations (n=2),

Control: 4 patients were withdrawn after randomisation

Reasons: Patient treated with radiotherapy instead of a chest tube (n=1), patient withdrew from the study after being randomized to the control condition (n=1), patient mistakenly given talc (n=1), patient received second administration of doxycycline before justified (n=1). One patient died 3 days after chest tube insertion.

Incomplete outcome data:

See outcome measure

1. Quality of life

Assessed with Dyspnea component of the Guyatt Chronic Respiratory Questionnaire (mean change from baseline, (SD), (number of patients evaluated)

I:

30 days: 5.2 (7.5) (59)

60 days: 6.5 (8.5) (44)

90 days: 7.2 (7.1) (33)

C:

30 days: 5.5 (8.7) (27)

60 days: 7.8 (7.1) (20)

90 days: 6.3 (8.2) (21)

The improvements were similar in both groups.

2. Dyspnea

Assessed with the Modified Borg scale score for dyspnea (0-10) at rest and after walking 100 feet

At rest, mean (SD), (number of patients evaluated)

I:

30 days: 0.9 (1.8) (62)

60 days: 1.3 (1.2) (49)

90 days: 0.4 (2.1) (35)

C:

30 days: 0.5 (2.1) (28)

60 days: 1.3 (1.4) (20)

90 days: 0.4 (1.9) (21)

No significant differences between the groups were found.

 After exercise (mean (SD))

I:

30 days: 2.2 (2.4) (60)

60 days: 2.3 (2.5) (46)

90 days: 2.2 (2.3) (34)

C:

30 days: 1.0 (2.4) (26)

60 days: 1.6 (2.3) (20)

90 days: 1.3 (2.3) (20)

There was a significant greater improvement in the indwelling catheter group at 30 days (p=0.05). No significant differences were found between the groups on the other time points.

3. Length of hospital

Admission, median, days

I: 1.0

C: 6.5

P<0.001

4. Costs

Not reported

5. Adverse events

During follow-up

Pleural infection, n (%)

I: 1 (1)

C: 0 (0)

Cellulitis, n (%)

I: 6 (7)

C: 0 (0)

Tumor seeding of catheter, tract, n(%)

I: 3 (3)

C: 0 (0)

Pain, n

I: 7

C: 1

In-hospital morbidity

I: fever (n=3), pneumothorax (n=3), re-expansion pulmonary edema (n=1), misplacement of catheter (n=2), re-expansion pulmonary edema (n=1), hypercapnic respiratory failure secondary to over-sedation (n=1)

C: fever (n=2), severe pain requiring PCA (n=2), hydropneumothorax (n=1), occluded chest tube requiring replacement (n=1)

6. Re-interventions

Defined as the number of late failures: Recurrence of effusion after an initially successful pleurodesis /recurrence of effusion after initial successful control (intervention group), n (%)

I: 12 (13%)

C: 6 (21%)

P=0.631

The patients in the control group had a minimum hospitalization of 3 days, while patients in the intervention group could be discharged within 16-24h.

Multiple imputation of the missing data in QoL and dyspnea outcomes did not change the outcome of the study.

The authors conclude that the difference in hospitalization was of uncertain clinical importance.

The authors did not proceed with the cost-effectiveness analysis, as these costs vary worldwide, and also within the participating centers.

Thomas, 2017

Type of study: RCT

Setting: multicenter

Country: Australia, New Zealand, Singapore, and Hong Kong

Source of funding: likely non-commercial. “The funders had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication”

Some of the authors served on advisory boards of pharmaceutical companies or medical technology companies

Inclusion criteria:

- adults with malignant pleural effusions with histocytological confirmation of pleural malignancy or recurrent exudative pleural effusions with no alternative cause in the setting of histocytologically proven extrapleural cancer.

Exclusion criteria:

- age younger than 18 years

- effusion less than 2 cm at maximum depth on imaging,

- expected survival of less than 3 months

- chylotholrax

- previous lobectomy or pneumonectomy on the side of effusion

- previous attempted pleurodesis

- pleurodesis

- pleural infection

- hypercapnic ventilatory failure

- blood leukocyte count less than 1000/µL

- pregnant or lactating women

- irreversible bleeding diathesis

- visual impairment

N total at baseline:

Intervention: 74

Control: 72

Important prognostic factors²:

age (range):

I: 71.0 (38-92)

C:70.5 (43-90)

Sex:

I: 53% M

C: 60% M

Cancer diagnosis:

I: lung: 26%, breast: 19%, mesothelioma: 27%

C:lung: 40%, breast: 6%, mesothelioma: 25%

Groups comparable at baseline? Some difference in % lung and breast cancer, but overall fairly similar.

Indwelling pleural catheter insertion, same day or overnight-stay procedure unless there were other medical reasons necessitating continual hospitalization. Drainage were performed by caregivers or nurses, guided by symptoms of patients.

Tube thoracostomy and instillation of talc slurry as per routine practice.

12 months

Two patients withdraw before receiving the allocated intervention, one in each group. Data of 144 patients were included in the intention-to-treat analyses.

The hospital admission data was complete (no missings).

19% of the data was missing in QoL and breathlessness scores.

1. Quality of life

Assessed using the EQ5D

Baseline, estimated mean (95%CI)

I: 31.2 (26.7;35.7)

C: 32.3 (27.8;36.8)

30d after intervention

estimated mean (95%CI)

I: 35.2 (30.6;39.8)

C: 34.5 (29.8;39.2)

“No significant differences were found in the magnitude of QoL improvement derived from indwelling pleural catheter treatment or pleurodesis”.

Assessed using a 100mm VAS

Baseline, estimated mean (95%CI)

I: 52.4 (43.4;61.4)

C: 56.7 (47.5;65.9)

30d after intervention, estimated mean (95%CI)

I: 61.5 (52.2;70.8)

C: 67.3 (57.6;77.0)

2. Dyspnea (breathlessness)

Assessed using a VAS scale

Baseline, estimated mean (95%CI)

I: 50.0 (37.2;62.7)

C: 52.2 (39.3;63.1)

30 days after procedure, estimated mean (95%CI)

I: 69.7 (56.7;82.6)

C:72.2 (59.0;85.5)

“No significant differences were found in the magnitude of symptom benefits derived from indwelling pleural catheter treatment or pleurodesis”

3. Length of hospital

Admission

Defined as the total number of days spent in hospital from trial intervention to death or up to the 12-month follow-up visit, median (IRQ)

I: 10 (3-17)

C: 12 (7-21)

Estimated difference: 2.92, 95%CI=0.43;5.84)

“The difference in total hospitalization days remained consistent after adjustment for minimization variables and days in trial and fitting center as a random effect during intention-to-treat and per-protocol analyses (Table 2).”

Defined as the total number of days and episodes of hospitalization from pleural effusion-related causes, median (IQR)

I: 1 (1-3)

C: 4 (3-6)

Estimated difference: 2.06, 95%CI=1.53;2.58)

This remained significant when adjusted for minimization variables and days in trial (p<0.001).

The median (IQR) days in hospital for the initial admission (for indwelling pleural catheter insertion or pleurodesis) was shorter for the indwelling pleural catheter group than the pleurodesis group.

I:1 (1-2)

C: 3 (3-4)

Estimated difference: 2.09, 95%CI=1.78;2.39)

“There was no subsequent number of effusion-related hospital days in the indwelling pleural catheter group until death (or 12 months follow-up) (median, 0 days (IQR, 0-1) vs 0 days (IQR, 0-5) for talc group; P=.08; HL estimate, -0.18 days; 95%CI, -0.41 to 0.01).”

4. Costs

Not reported

5. Adverse events

number of patients experiencing a serious adverse event, n(%)

I: 1 (1)

C: 3 (4)

Number of patients that experienced at least one adverse event, n(%)

I: 22 (30)

C: 13 (18)

6. Re-interventions

Defined as the number of patients that required further pleural interventions for ipsilateral fluid, n(%)

I: 3 (4.1)

C: 16 (22.5)

P=0.001, difference in proportions: 0.18, 95%CI=0.08;0.29.

Study reference

(first author, publication year)

Describe method of randomisation

Bias due to inadequate concealment of allocation?

(unlikely/likely/unclear)

Bias due to inadequate blinding of participants to treatment allocation?

(unlikely/likely/unclear)

Bias due to inadequate blinding of care providers to treatment allocation?

(unlikely/likely/unclear)

Bias due to inadequate blinding of outcome assessors to treatment allocation?

(unlikely/likely/unclear)

Bias due to selective outcome reporting on basis of the results?

(unlikely/likely/unclear)

Bias due to loss to follow-up?

(unlikely/likely/unclear)

Bias due to violation of

intention to treat analysis?

(unlikely/likely/unclear)

Boshuizen, 2017

Randomization software, 1:1 ratio, stratified for tumor type and WHO performance status.

unlikely

Likely

Likely

Likely

Unclear/likely, results for quality of life not published (were mentioned in trial register). Furthermore, no standard deviations provided, which hampers pooling of the results.

Unclear, loss of follow-up is high, reasons for loss-to-follow up for the per protocol analyses provided.

unlikely

Demmy, 2012

Permuted block randomization, stratified for inpatient status, disease type and current systematic chemotherapy treatment.

Unlikely

Likely

likely

Likely

Likely, the results of the QOL questionnaires are not reported.

Unclear, the reasons for loss-to-follow-up are not reported per groups. Furthermore, only information about survival provided.

Unclear, not stated

Davies, 2012

Minimization, criteria were the tissue type (mesothelioma vs nonmesothelioma) and WHO performance status. Randomisation was carried out by a central telephone randomisation service

unlikely

Likely

Likely

Likely for PRO’s. Unlikely for SAE’s and costs (blinded independent reviewer)

Unlikely

Likely, loss to follow-up is quite high. Mortality rate was high, reasons for loss-to-follow up not further provided.

Unlikely:

“data were analysed on an intention-to-treat basis and all randomized patients in whom an outcome was available were included in the analysis.”

Putnam, 1999

Consecutively numbered envelops. Distribution indwelling catheter: doxycycline pleurodese = 2:1

Unclear, not clear whether the envelopes were sealed and opaque.

Likely

Likely

Likely

Unlikely

Likely. Loss to follow-up was quite high, probably due to a high mortality rate, but the reasons have not been provided. Furthermore, loss to follow-up is higher in the intervention group (65% vs 53%)

Unclear.

“…Only patients who received the appropriate treatment without protocol violation were included”

Thomas, 2017

Computer randomization (1:1; in real time). A balance between kept between key prognostic factors (mesothelioma vs nonmesothelioma, known trapped lung vs not) and Australia/New Zealand vs Asian.

Unlikely

Likely

Likely

Likely

Unlikely

Unlikely

unlikely

Auteur en jaartal

Redenen van exclusie

Wahidi, 2016

Maakt een vergelijking tussen agressieve, dagelijkse drainage via IPC en standaard (om de dag) drainage. Geen pleurodese

Patil, 2016

Abstract

Kheir, 2016

Systematische review, voldoet op zich aan de inclusiecriteria, maar kijkt alleen naar de uitkomstmaten success rate, reinterventies en complicaties. De geïncludeerde artikelen zijn afzonderlijk geïncludeerd in deze literatuursamenvatting

Clive, 2016

Netwerkanalyse, ook veel vergelijkingen geïncludeerd die niet interessant voor de PICO. De twee RCT’s die de PICO beantwoorden zijn afzonderlijk geïncludeerd in deze literatuursamenvatting.

Puri, 2012

Kijkt naar de kosteneffectiviteit, maar gaat uit van de resultaten van prospectieve en retrospectieve, waarschijnlijk geen vergelijkende studies. Amerikaanse kostprijzen

Fysh, 2014

Geen RCT: “Patients were not randomized but were allowed to choose, in consultation with the attending physician, between IPC and pleurodesis”

Beyea, 2012

Lijkt narratieve review, wel search uitgevoerd

Michaud, 2011

Abstract

Olden, 2010

Kijkt naar de kosteneffectiviteit, maar gebaseerd op voornamelijk retrospectieve studies. Amerikaanse kostprijzen

Walker, 2016

Geen RCT “the major limitation of this study is the lack of randomisation”

Freeman, 2013

Geen RCT

Putnam, 2000

Geen RCT

Thomas, 2017

Abstract