Supplementary Appendix

This appendix has been provided by the authors to give readers additional information about their work.

Supplement to: Brown SGA, Ball EL, Perrin K, et al. Conservative versus interventional treatment for spontaneous
pneumothorax. N Engl J Med 2020;382:405-15. DOI: 10.1056/NEJMoa1910775
 SUPPLEMENTARY APPENDIX

CONSERVATIVE VERSUS INTERVENTIONAL TREATMENT FOR SPONTANEOUS

PNEUMOTHORAX
1,2
Simon GA Brown PhD, 1,3Emma L Ball FRACP, 4,5Kyle Perrin PhD, 6,7Stephen E Asha FACEM,
4
Irene Braithwaite PhD, 8,9Diana Egerton-Warburton MPH, 10Peter G Jones MSc,
11,12,13
Gerben Keijzers PhD, 14,15Frances B Kinnear PhD, 7,16Ben C H Kwan PhD,
17
KV Lam FRANZCR, 18,19YC Gary Lee PhD, 20Mike Nowitz FRANZCR,
1
Catherine A Read BSc(Hons), 21Graham Simpson MD, 22,23Julian A Smith FRACS,
24
Quentin A Summers DM, 4,5Mark Weatherall FRACP, 4,5Richard Beasley DSc

1
Centre for Clinical Research in Emergency Medicine, Harry Perkins Institute of Medical Research,
Royal Perth Hospital and the University of Western Australia, Perth, WA, Australia
2
Aeromedical and Retrieval Services, Ambulance Tasmania, Hobart, Tasmania, Australia
3
Department of Respiratory Medicine, Royal Hobart Hospital, Hobart, Tasmania, Australia
4
Medical Research Institute of New Zealand, Wellington, New Zealand
5
Capital and Coast District Health Board, Wellington, New Zealand
6
Emergency Department, St George Hospital, Kogarah, NSW, Australia
7
St George Clinical School, Faculty of Medicine, University of New South Wales, Kensington, NSW,
Australia
8
Emergency Department, Monash Medical Centre, Clayton, VIC, Australia
9
Department of Medicine, School of Clinical Sciences at Monash Health, Clayton, VIC, Australia
10
Adult Emergency Department, Park Road, Grafton, Auckland 1142, New Zealand
11
Emergency Department, Gold Coast Health Service District, QLD, Australia
12
School of Medicine, Bond University, Gold Coast, QLD, Australia
13
School of Medicine, Griffith University, Gold Coast, QLD, Australia
14
Emergency Medical and Children's Services, The Prince Charles Hospital, QLD, Australia
15
University of Queensland, QLD, Australia
16
Department of Respiratory and Sleep Medicine, The Sutherland Hospital, Sydney, NSW, Australia
17
Royal Perth Hospital Imaging, Royal Perth Hospital, WA, Australia
18
Respiratory Medicine, Sir Charles Gairdner Hospital, Perth, WA, Australia
19
Centre for Respiratory Health, School of Medicine & Pharmacology, University of Western Australia,
Perth, WA, Australia
20
Pacific Radiology, Wellington, New Zealand
21
Department of Respiratory Medicine, The Cairns Hospital, Cairns, QLD, Australia
22
Department of Cardiothoracic Surgery, Monash Health, Clayton, VIC, Australia
23
Department of Surgery, School of Clinical Sciences at Monash Health, Monash University, Clayton,
VIC, Australia
24
Respiratory Department, Royal Perth Hospital, Perth, WA, Australia

[NEJM: PSP OLS Rev #3.1 October 22 2019] 1

Index
List of investigators and sites 3
Section One: Exclusion criteria 5
Section Two: Statistical analysis 5
Section Three: Changes to the statistical analysis plan 6
Figure S1: Graphic of Collins Method for determining the ‘sum of intrapleural distances’, from 8
which pneumothorax size is estimated. %Collins = 4.2 +4.7(A+B+C)
Figure S2: Calculation of pneumothorax size from CXR of participant enrolled into the trial 9
Figure S3: Frequency plot of the days after randomization that the eight week visit occurred in 10
those participants without prior resolution, excluding treatment failures

Figure S4: Intention To Treat (ITT) Kaplan-Meier survival plot for time to radiographic 11
pneumothorax resolution.
Figure S5: Intention To Treat (ITT) Kaplan-Meier survival plot for time to symptomatic recovery, i.e. 12
last symptoms or use of medication to treat symptoms related to pneumothorax.
Figure S6: Intention To Treat (ITT) Kaplan-Meier survival plot for pneumothorax recurrence. 13
Table S1. Participant characteristics 14
Table S2. Reasons for conversion to invasive management in the conservative management group 15
Table S3. Agreement between treating clinician and masked radiologists for CXR 16
resolution at 56 days (for CXRs available for masked assessment by radiologists)
Table S4. Study-related procedures by treatment group 17
Table S5. Length of stay in the first eight weeks, by treatment group 18
Table S6. Radiological procedures by treatment group 19
Table S7. Patient-related outcomes and satisfaction at final assessment by treatment group 20
Table S8. Interaction analyses with pre-specified variables 21

[NEJM: PSP OLS Rev #3.1 October 22 2019] 2

List of investigators and sites
Western Australia:
Armadale-Kelmscott Memorial Hospital, Armadale, WA, Australia (David McCutcheon & Stephen
MacDonald); Bunbury Hospital, Bunbury, WA, Australia (Adam Coulson, Hugh Mitenko); Busselton
Hospital, Busselton, WA, Australia (Phil Chapman, Hugh Mitenko, Sandra Rennie); Centre for Clinical
Research in Emergency Medicine, Harry Perkins Institute of Medical Research, University of Western
Australia, Perth (Sophie Damianopoulos, Cathy Read); Fiona Stanley Hospital, Murdoch, WA,
Australia (Glenn Arendts, Yusuf Nagree, Ranjan Shrestha); Fremantle Hospital, Fremantle, WA,
Australia (Emma Ball, Paula Johnston, Peter Kendall, Yusuf Nagree); Kalgoorlie Hospital, Kalgoorlie,
WA, Australia (Vahid Moosavi, Matthew Summerscales); Rockingham Hospital, Rockingham, WA,
Australia (Rod Ellis, Leanne Hartnett); Royal Perth Hospital, Perth, WA, Australia (Emma Ball, Daniel
Fatovich, Miranda Smith, Claire Tobin); Sir Charles Gairdner Hospital, Perth, WA, Australia (Tor
Ercleve, Claire Falzon, Edward Fysh, Gary Lee, David Mountain); St John of God Midland, WA,
Australia (Nicole Ghedina, David Manners, Francesco Piccolo); Swan District Hospital, Middle Swan,
WA, Australia (Susan Mills, Amanda Stafford)

Victoria, Australia:
Box Hill Hospital, Box Hill, Vic, Australia (Paul Buntine, Andrew Maclean, Julia Ng); Casey Hospital,
Berwick, Vic, Australia; Dandenong Hospital, Dandenong; Vic, Australia; Monash Medical Centre,
Clayton, Vic, Australia (Ali Asadpour, Gaby Blecher, Simon Craig, Diana Egerton-Warburton, Andis
Graudins, Barton Jennings, Robert Meek, Alastair Meyer, Kirsty Povey, Rachel Rosler, Julian Smith,
Kathryn Wilson)

Tasmania, Australia:
Royal Hobart Hospital, Hobart, Tasmania, Australia (Emma Ball, Simon Brown, Geoffrey Couser, John
Dewing)

Queensland, Australia:
Bundaberg Base Hospital, Bundaberg, Qld, Australia (Pradeep Bambery, Michael Chang, Greg
Treston); Gold Coast Health Service District, Southport, Qld, Australia (Gerben Keijzers, Toby Tang);
Ipswich Hospital, Ipswich, Qld, Australia (Kylie Baker, Adel Braasch); Logan Hospital, Meadowbrook,
Qld, Australia (Deepak Doshi); Mater Hospital, South Brisbane, Qld, Australia (Simon Bowler, David
Serisier, Joseph Ting); Nambour General Hospital, Nambour, Qld, Australia (Michael Bint, John Fuller,
Ogilvie Thom, Yusuke Ueno-Dewhirst); Royal Brisbane and Women's Hospital, Herston, Qld, Australia
(Kevin Chu, Duncan McAuley, Christopher Zappala); The Cairns Hospital, Cairns, Qld, Australia (Mark
Little, Graham Simpson, Stephen Vincent); The Prince Charles Hospital, Chermside, Qld, Australia
(Frances Kinnear, Philip Masel); The Townsville Hospital, Douglas, Qld, Australia (Jeremy Furyk,
Huang-Liang Lee, Anthony Matthieson); Toowoomba Hospital, South Toowoomba, Qld, Australia
(Simon Tebbutt, Kathleen Hyland, Ross Sellars)

New South Wales, Australia:

Blacktown Hospital, Blacktown, NSW, Australia; Mount Druitt Hospital, Mount Druitt, NSW, Australia
(Reza Ali, James Kwan); John Hunter Hospital, Lambton Heights, NSW, Australia (David Arnold,
Conrad Loten); Royal North Shore Hospital, St Leonards, NSW, Australia (Mark Gillett, Michael
Hibbert); St George Hospital, Kogarah, NSW, Australia (Stephen Asha, Steven Lindstrom); The

[NEJM: PSP OLS Rev #3.1 October 22 2019] 3

Sutherland Hospital, Sydney, NSW, Australia (Allison Moore, Ben Kwan, David Mah); Westmead
Hospital, Westmead, NSW, Australia (James Kwan)

New Zealand:
Auckland City Hospital, Auckland, NZ (Peter Jones, Margaret Wilsher); Christchurch Hospital,
Christchurch, NZ (Lutz Beckert); Middlemore Hospital, Auckland, NZ (Jeff Garrett, Hamish Read)
Waikato Hospital, Hamilton, NZ (Catherina L Chang, Hollie Ellis, Robert J Hancox); Wellington
Hospital, Wellington, NZ (George Bardsley, Richard Beasley, Kyle Perrin, Sharon Power)

[NEJM: PSP OLS Rev #3.1 October 22 2019] 4

Section One: Exclusion criteria

• Previous PSP on the same side

• Secondary pneumothorax (defined as occurring in the setting of acute trauma or underlying lung
disease including asthma with preventive medications or symptoms in the preceding two years)
• Coexistent hemothorax
• Bilateral pneumothorax
• ‘Tension’ pneumothorax’ (systolic BP <90 mmHg, mean arterial pressure <65 mmHg, or shock
index HR/SBP ≥1)
• Pregnancy at time of enrolment
• Social circumstances (inadequate support after discharge to re-attend hospital if required or
unlikely to present for study follow up)
• Planned air travel within the following 12 weeks

Section Two: Statistical analyses

The primary outcome was assessed by an absolute risk difference and confidence interval with a non-
inferiority bound of -9%. A non-significant P-value implies that the null hypothesis of inferiority is
accepted for conservative compared to interventional therapy. A significant P-value means the null
hypothesis of inferiority is rejected in favor of the alternative hypothesis of non-inferiority.

Interactions between the primary outcome variable by intention to treat were assessed for age,
clinician estimated size, and symptom duration (illustrated by comparison of odds ratio for association
comparing the 25th and 75th percentiles of these variables from the control group data summaries);
and by smoking status. A logistic regression model was used. An interaction P-value that was not
statistically significant means there was no difference in the effect of randomized treatment in relation
to the sub-group.

McNemar’s test for paired proportions and estimation of the paired differences for clinician compared
to radiologist for ‘not resolved’ are used for assessment of agreement

[NEJM: PSP OLS Rev #3.1 October 22 2019] 5

Kaplan-Meier survival curves and a Cox Proportional-Hazards estimate of the Hazard ratio (HR) for
time to event were used for: time to radiological resolution (a HR <1 favors the first-named treatment);
time to symptomatic recovery (a HR <1 favors the first-named treatment); and time to ipsilateral
pneumothorax recurrence with all data and based on data to 12 months (a HR less than one favors
the second-named therapy).

Relative risk for an event and absolute risk difference expressed as a percentage were estimated for:
Adverse events, pneumothorax recurrence by 12 months, pneumothorax recurrence overall, use of a
drain for 72 hours or more, use of at least one CT scan, use of at least one invasive procedure, and
complete symptomatic recovery.

The Mann-Whitney test and the Hodges-Lehmann estimator of location shift with 95% CI were used
for Hospital bed-days, count of CT scans, and days off work due to pneumothorax.

A t-test was used to estimate the difference in the mean number of CXRs. Poisson regression was
also used for the rate of use of CXR, CT scans, number of adverse events, and invasive procedures.
Ordinal regression was used to estimate the odds of a higher (better satisfaction) versus lower score
(worse satisfaction) on the satisfaction index. An odds ratio of greater than one favors the second-
named therapy.

SAS version 9.4 (SAS Institute Inc., Cary, NC, USA) was used for all analyses.

Section Three: Changes to the Statistical Analysis Plan

The Statistical Analysis Plan did not specify the window for an eight week visit, nor how missing data
by Day 56 would be handled. Analysis was undertaken on those participants who had data available
by this designated time point. As a result, we undertook a complete-case-analysis in which data from
participants in whom the eight week clinic visit occurred after eight weeks were treated as ‘missing’,
unless a CXR during the eight week window or later demonstrates a persisting pneumothorax thereby
confirming treatment failure. The ‘window’ for an eight week visit outcome was the week up until 56
days; thus any demonstrated resolution prior to 56 days was taken as a primary outcome of resolution,
any persistent pneumothorax after 49 days (including after 56 days) was taken as a primary outcome
of failure, and remaining cases were treated as missing data.

[NEJM: PSP OLS Rev #3.1 October 22 2019] 6

Two sensitivity analyses were undertaken as follows:

In the primary sensitivity analysis the time point was extended to Day 63 (ie eight weeks plus 7 days).
The rationale for this analysis was that the strict 8 week time point for the primary outcome variable
set at day 56 did not allow inclusion of data from participants in whom their eight week clinic was
scheduled for, and/or took place after 56 days. The intent of the study was to establish whether there
was resolution at the time of the week eight visit. The protocol did not specify that the eight week
follow-up must be undertaken before 56 days, and investigators were not advised there was a strict
cut-off for interpretation of the eight week follow-up CXR. Nor did the protocol state a ‘window’ in
which the eight week visit should take place. The frequency plot (Figure S1) provides information of
the distribution of week eight visits around the Day 56 time point.

In the secondary sensitivity analysis, missing data at Day 56 was imputed as ‘failure’ to provide an
estimate of the difference between groups, if all missing data represented actual treatment failures
using a strict Day 56 cut-off.

[NEJM: PSP OLS Rev #3.1 October 22 2019] 7

Figure S1: Graphic of Collins Method for determining the ‘sum of interpleural distances”,
from which pneumothorax size is estimated. %Collins = 4.2 +4.7(A+B+C)

Figure modified from Collins et al. Quantification of Pneumothorax Size on Chest Radiographs Using
lnterpleural Distances: Regression Analysis Based on Volume Measurements from Helical CT.
American Journal of Roentgenology. 1995;165:1127-130.

[NEJM: PSP OLS Rev #3.1 October 22 2019] 8

Figure S2: Calculation of pneumothorax size from CXR of participant enrolled into the trial
Demonstration of the method of assessment of the size of the pneumothorax using the Collin’s method. In this
case, the size of the pneumothorax is 64%, the mean size of pneumothoraces included in the study.
A+B+C = 12.64 Calculated size is: 4.2 +4.7(A+B+C) = 4.2 + (4.7 x 12.64) = 63.6%

[NEJM: PSP OLS Rev #3.1 October 22 2019] 9

Figure S3: Frequency plot of the days after randomization that the eight week visit occurred
in those participants without prior resolution.

Participants with CXRs showing non-resolution of pneumothorax in this time period are considered as
treatment failures in the primary analysis, and not included in this figure.

[NEJM: PSP OLS Rev #3.1 October 22 2019] 10

Figure S4: Kaplan-Meier survival plot for time to radiographic resolution of pneumothorax as
assessed by investigator.

[NEJM: PSP OLS Rev #3.1 October 22 2019] 11

Figure S5: Kaplan-Meier survival plot for time to symptomatic recovery, i.e. last symptoms or
use of medication to treat symptoms related to pneumothorax. Time scale is days.

[NEJM: PSP OLS Rev #3.1 October 22 2019] 12

Figure S6: Kaplan-Meier survival plot for pneumothorax recurrence. Time scale is days.

[NEJM: PSP OLS Rev #3.1 October 22 2019] 13

Table S1: Participant characteristics

Interventional Group Conservative Group

N Median Min to Max N Median Min to Max
(IQR) (IQR)
Age (years) 154 23.5 15 to 49 162 24 14 to 47
(20 to 31) (19 to 33)
BMI (kgm-2) 141 20.9 14.3 to 34.5 153 20.7 14.4 to 32.4
(18.8 to 23.7) (18.7 to 22.8)
BORG 112 1 0 to 5 133 1 0 to 7
(0 to 2) (0.5 to 3)
Height (cm) 141 176 152 to 199 154 180 153 to 202
(171 to 183) (174 to 185)
Heart rate (bpm) 132 73 46 to 112 149 76 50 to 124
(65 to 80) (66 to 86)
Pack year tobacco 138 1 0 to 180 145 0 0 to 48
(0 to 6) (0 to 6)
Pain score 119 2 0 to 9 138 2 0 to 10
(0 to 4) (1 to 3)
Respiratory rate (min) 134 16 10 to 24 144 16 10 to 30
(16 to 18) (15 to 18)
Systolic BP (mmHg) 134 117 95 to 160 148 120 80 to 160
(110 to 125) (110 to 128.5)
Pneumothorax size (%) 154 65.5 32.4 to 100 162 55.9 32.4 to 100
(46.5 to 88.8) (43.2 to 86)
Pneumothorax size (cm) 154 13.1 6 to 58 162 11 6 to 216
(9 to 18) (8.3 to 17.4)
Oxygen saturation (%) 134 98 94 to 100 148 98 91 to 100
(97 to 99) (96 to 99)
Symptom duration (hours) 153 13.1 1.7 to 663.1 160 11.1 2.1 to 541.8
(5.2 to 48) (5 to 34.9)
Weight (kg) 142 65 39 to 112 154 67 41 to 110
(57.5 to 76) (60 to 76)

IQR: Interquartile range

[NEJM: PSP OLS Rev #3.1 October 22 2019] 14

Table S2. Reasons for conversion to interventional management in the conservative

management group

(Participants may have had interventional management for more than one reason)

Reason for conversion to interventional management N

Abnormal physiological observations 8

Intolerable symptoms 8

Difficulty mobilizing 3

Increasing size of pneumothorax 3

Hemothorax 2

Patient anxiety 2

Slow resolution 1

[NEJM: PSP OLS Rev #3.1 October 22 2019] 15

Table S3. Agreement between treating clinician and masked radiologists for CXR

resolution at 56 days (for CXRs available for masked assessment by radiologists)

Radiologist resolved

Clinician resolved No Yes Total

No 2 0 2 (0.8%)

Yes 14 223

Total 16 (6.7%) 239

Chi-square DF P

McNemar's test 14.0 1 <0.001

Estimate % (95% CI)

Clinician minus -5.9 (-8.8 to -2.9) <0.001

radiologist not
resolved

[NEJM: PSP OLS Rev #3.1 October 22 2019] 16

 Table S4. Study-related procedures by treatment group

Intervention Group Conservative Group

Count of procedures per participant N/N (%) N/N (%)
Underwater Drain applied 145/154 (94.2) 25/162 (15.4)
Underwater Drain ≥72 hours 78/144 (54.2) 15/25 (60.0)
Suction applied 52/145 (35.8) 12/25 (48.0)
N/N (%) Mean Median Min to Max N/N (%) Mean Median Min to Max
(SD) (IQR) (SD) (IQR)
One or more procedures 145/154 1.7 1 (1 to 2) 0 to 5 25/162 0.3 0 (0 to 0) 0 to 5
(94.2) (1.2) (15.4) (0.8)

- One or more non-Seldinger 34/154 0.3 0 (0 to 0) 0 to 3 10/162 0.1 0 (0 to 0) 0 to 2

intercostal chest tube (22.1) (0.6) (5.2) (0.3)
- Needle Aspiration 1/154 0 0 (0 to 0) 0 to 1 1/162 0 0 (0 to 0) 0 to 1
(0.7) (0.1) (0.6) (0.1)
- One or more Seldinger intercostal 142/154 1.1 1 (1 to 1) 0 to 4 19/162 0.1 0 (0 to 0) 0 to 4
chest tube (92.2) (0.6) (11.7) (0.5)
- Thoracotomy 6/154 0 0 (0 to 0) 0 to 1 0/162 0 (0) 0 (0 to 0) 0 to 0
(3.9) (0.2) (0)
- One or more VATS procedures 33/154 0.2 0 (0 to 0) 0 to 2 10/162 0.1 0 (0 to 0) 0 to 1
(21.4) (0.4) (6.2) (0.2)

144* 6.1 3.6 0 to 66.6 161* 1 0 (0 to 0) 0 to 51.6

Drain insertion duration (Days)
(8.6) (0.8 to 8.1) (4.6)
- Drain insertion duration only for 6.1 3.6 6.9 4.4
144* 0 to 66.6 24* 0.3 to 51.6
those who received a drain (Days) (8.6) (0.8 to 8.1) (10.3) (1.6 to 7.5)

Suction application only in those who 51* 6.5 5 0 to 18.6 11* 4.7 3.9 0.2 to 10.7
received suction (Days) (5) (2.1 to 10.6) (3.3) (1.8 to 7.7)
* Drain end time not available for one participant in each group, suction end time not available for one participant in each group
VATS: Video-assisted thoracic surgery

[NEJM: PSP OLS Rev #3.1 October 22 2019] 17

Table S5. Length of stay in the first eight weeks, by treatment group

Intervention Group Conservative Group

Analyzed Mean Median Min to Analyzed Mean Median Min to Max

N (SD) (IQR) Max N (SD) (IQR)

Total Length of stay (Days) 154 6.1 3.8 0 to 47.7 162 1.6 0.2 0 to 28.2
(7.6) (0.8 to 9.3) (3.5) (0.2 to 0.8)
- Initial Length of stay 149 4.6 3 0 to 39 161 1 0.2 0 to 28.2
(Days) (5.7) (0.7 to 6.1) (2.8) (0.2 to 0.6)

- Readmission Length of 154 1.7 0 0 to 34.8 160 0.6 0 0 to 17

stay (Days) (4.5) (0 to 0.1) (2.1) (0 to 0)

Number of readmissions per 154 0.4 0 0 to 3 162 0.2 0 0 to 3

participant (N) (0.8) (0 to 1) (0.5) (0 to 0)

- Length of stay only in 41 6.3 4 0.1 to 34.8 24 4.1 3.55 0.1 to 17

those readmitted (Days) (7) (1.1 to 9.8) (4.1) (0.6 to 5.9)

[NEJM: PSP OLS Rev #3.1 October 22 2019] 18

Table S6. Radiological procedures by treatment group

Intervention Group Conservative Group

Analyzed Mean Median Min to Analyzed Mean Median Min to
N (SD) (IQR) Max N (SD) (IQR) Max

Number of Chest X-rays (N) 148 10.9 9 2 to 40 154 6.4 5 (4 to 7) 1 to 30

(7.1) (6 to 14) (3.9)

Number of CT scans 146 0.2 0 0 to 2 154 0.1 0 (0 to 0) 0 to 6

(0.4) (0 to 0) (0.6)

Count CT scans per participant N/N (%) N/N (%)

- At least 1 CT scan 28/146 (19.2) 12/154 (7.8)

- 0 118/146 (80.8) 142/154 (92.2)

- 1 27/146 (18.5) 9/154 (5.8)

- 2 1/146 (0.7) 2/154 (1.3)

- 6 0 (0) 1/154 (0.7)

[NEJM: PSP OLS Rev #3.1 October 22 2019] 19

Table S7. Patient-related outcomes and satisfaction at final assessment by treatment group

Intervention Group Conservative Group

Analyzed Mean Median Min to Analyzed Mean Median Min to
N (SD) (IQR) Max N (SD) (IQR) Max

Duration of symptoms and/or 137 21.9 15 -1 to 84 147 20.2 14 0 to 89

analgesia use (Days) (20.3) (5 to 34) (17.6) (8 to 28)

Days off work (Days) 125 10.9 6 0 to 59 142 6 3 0 to 33

(12.7) (2 to 14) (7.3) (1 to 8)

Satisfaction score 140 5.3 5.5 1 to 6 150 5.4 6 1 to 6

(1.1) (5 to 6) (1) (5 to 6)
Patient satisfaction score at N/N (%) N/N (%)
final assessment

- (1) Very dissatisfied 5/140 (3.6) 4/150 (2.7)

- (2) Dissatisfied 1/140 (0.7) 0/150 (0)
- (3) Slightly dissatisfied 3/140 (2.1) 3/150 (2.0)
- (4) Slightly satisfied 6/140 (4.3) 2/150 (1.3)
- (5) Satisfied 55/140 (39.3) 53/150 (35.3)
- (6) Very satisfied 70/140 (50.0) 88/150 (58.7)

[NEJM: PSP OLS Rev #3.1 October 22 2019] 20

Table S8. Interaction analyses with pre-specified variables

Interventional versus Conservative

56 day resolution P
Odds ratio (95% CI)

Randomised treatment alone 3.86 (0.79 to 18.9) 0.096

P
Comparison levels of interacting variable
Interaction
Age (per decade older) 19 years (25th 33 years (75th
percentile percentile
conservative) conservative)
2.77 (0.38 to 20.3) 5.43 (0.57 to 51.7) 0.63

Clinician estimated size (per 8.3 cm (25th percentile 17.4 cm (75th

10 cm larger) control) percentile control)
5.36 (0.68 to 42.0) 3.71 (0.75 to 18.5) 0.52

Symptom duration (per hour 5 hours (25th 34.9 hours (75th

longer) percentile control) percentile control)
3.42 (0.56 to 20.9) 3.48 (0.65 to 18.8) 0.92

Smoking Current Never Ex

NA 3.28 2.70 0.99
(0.36 to 30.3) (0.24 to 30.6)

[NEJM: PSP OLS Rev #3.1 October 22 2019] 21