change to "...recent recommendations from the Association for Respiratory Technology & Physiology (ARTP) (https://www.artp.org.uk/Spirometry-Overview), requiring..."

Please insert this summary underneath the graph, and put the actual values for both cohort in please: Have I interpreted this the right way round?

"The time to COPD diagnosis has increased since the year 2000; after 5 years, the 2000-2004 cohort had a 10% chance of being diagnosed, compared with the 2015-19 cohort that had a xxx% chance of receiving the same diagnosis."

Replace with text from Word document: "Data note: Analysis of the broader definition of lung function was based on valid entries in any of the following indicators: FEV1, FVC, FEV1/FVC, peak expiratory flow."

the appendix should be for the analyses requested by the steering committee, so that everything's in one report. You must already have the coding for it, as you did it for the UKSC. I put the graphs and text for these analyses in the word doc I sent on 14th Jan (page 78 onwards)

check the rows - some of them are shaded or not shaded incorrectly

should be in row above

remove highlight from this row

add highlight from this row

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Delete - the categories now show the % with each event. Matches the group above

Present the mod and severe exacerbations in the same way (for baseline and follow up periods) i.e. mean and then categories, or categories only. Probably present both if it's easy enough

align with the below rows

Need a new heading for this one, to explain this is showing the number of patients within each category. Use the following text as the heading: "Blood eosinophil count (BEC) within 5 years of index date - highest recorded; n (%)"

you were going to swap the order, so it's the same as other tables

Need a new paragraph afterwards saying "Restricting this analysis to patients without a diabetes diagnosis revealed..." . I can't write this until you've done the analysis though.

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change to "...is the number..."

change to: "...for osteoporosis- or diabetes-related steroid..."

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After this, we need a heading "Newly diagnosed patients" following by this sentence: "The denominator was newly diagnosed patients not on triple therapy, with any new therapy between baseline and follow-up periods."

After the graph, insert: "The median time between latest baseline exacerbation and the first additional therapy category decreased between 2000-2012, before rising again over the following seven years."

We discussed with Con about you presenting similar data for the already diagnosed patients. Con's suggestion for the already diagnosed group - within each year cohort, find % with a change and then look for median time for these patients.

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think this was one of the charts where the undiagnosed group were going to be removed

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Please insert "Data note:" in bold after these definitions. After the definitions, please insert: "Patients were categorised based on the highest therapy received in the baseline and follow-up periods e.g. patients in the reliever-only group were not prescribed any higher therapy within that period."

remove line after this para

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This was going to be split into i) 'no change - not on therapy', ii) 'no change - on therapy

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I had suggested inserting the sentence "The 20-year trend [was comparable with/differed from] that of the general UK population aged 40 years or above, which …… " and asked you to look at OPCRD for all adults aged 40-64 and then 65+, to see if trends were similar or not. No graphs/tables needed, it was just to see the patterns. Is there time?

Derek, you were going to look at this in OPCRD for all adult aged 40+. Is there time??

please start the graph y axis at 0%, not 20%

Reference: https://www.nhs.uk/conditions/vaccinations/flu-influenza-vaccine/

This was a comment from the previous edited version I sent you: "need to explain why 24 months when guidelines recommend annually. Possibly to pick up those just outside 12m window, but very imprecise."

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Derek - you were going to look at the general population in OPCRD so that we could write this. Will you have time? We either need to check OPCRD and edit this sentence, or delete the sentence (last resort).

It was suggested to add the following reference here, is this possible?

https://www.nhs.uk/conditions/vaccinations/when-is-pneumococcal-vaccine-needed/

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DP queried this, as undiagnosed are getting referrals which makes no sense. You were going to explore the codes being used for this, to see what was going on. Simply deleting the undiagnosed group from this analysis won't solve the issue if it relates to codes, as data for the already/newly diagnosed groups will be wrong as well.

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this was going to be changed to 'QRISK or cardiac assessment', instead of purely being QRISK. Is this possible?

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Alter title of the graph to: "Proportion of patients with COPD exacerbation history explored"

Add the following text above this heading: "The time frame for these analyses differed depending on the patient group: i) newly diagnosed patients: 12 months either side of the first COPD diagnostic code, ii) already diagnosed/ undiagnosed patients: 12 months either side of the index date i.e. 1st January in each year."

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we need better explanation here - what does a resp referral include i.e. referral to what (can we use the same wording as in 3.1.9 i.e. "A respiratory referral was defined as either a coded referral or being under specialist care according to EMR data.")?

The fact that so few patients in any group had it, suggests it's rarely used? Please check the proposed wording below as well.

Need to include the following text underneath the table: "Less than 10% of already/newly diagnosed patients had a respiratory referral code in their EMR during the 12-month baseline period, irrespective of the year. The discrepancy between these data and those presented in 4.2 (insert cross-ref please), may be explained either by the different patient populations, or that this specific clinicians used alternative codes to indicate respiratory referrals."

missing analyses for BMI and full blood count - they're specified in the protocol

There's meant to be an 'occupation' analysis before the smoking status. Can this be done?

have you done a combined version of this as well e.g spiro or PEF? If so, please put it underneath 3.1.2.

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This sentence should move above the graph, after a similar intro sentence to the other sections. Please delete from here and insert the following above the graph: "Data note: Analysis of maintenance inhaled COPD treatment was based on valid entries in therapies that were categorised into the following: SABA, SAMA, SAMA/SABA, LABA only, LAMA only, ICS only, LABA-ICS, LABA-LAMA, LABA-LAMA-ICS, or none. Patients were categorised based on the highest therapy received e.g. patients in the reliever-only group were not prescribed any higher therapy within the 12 month baseline period."

delete - in the last edit I went through and removed this from all headers for consistency

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lower case 'r' please

We need to put some text underneath this table. Suggest the following: "The proportion of patients with full blood counts recorded in their EMR increased over the 20-year period, from approximately 10% in 2000, to 60% in 2019. The comparable data in all three patient groups, suggests this reflects increased use/recording of blood count data within the general population of adults aged 40 years and above."

In the US/UK pre-meeting with AZ, Brooklyn said she included patients if they had height and weight. Did you do the same, or did you use BMI indicator only?

Ideally these should appear in the left hand pane as navigation, just like the higher level headings. Don't worry if it will take too long though

After the table, put the following from the word doc and please check it is accurate - this was my assumption without seeing the graph: "From 2004 onwards, trends for the broader lung function data were similar to those based on spirometry alone, suggesting that patients did not perform peak expiratory flow (PEF) in isolation and the majority of PEF data was obtained during spirometry. Prior to 2004, the proportion of patients performing either spirometry or PEF was comparable to the analysis of PEF alone (Section 2.2.2); hence that PEF was more commonly used prior during this period, sometimes in combination with spirometry."

Please move the spiro/PEF to here, from the appendix

Change wording as per the word file i.e. "Proportion of high-risk patients receiving a diagnostic COPD assessment during the baseline period"

please move the KM plot here, from the appendix

needs to move after 2.1, so it follows on logically

the patients samples in 1.7 and 1.8 differ from the previous report. Why is this?

Also, David asked for percentages to be added to the tables - is that possible?

Suggest changing this to "Patients meeting the above eligibility criteria, by cohort year"

Sorry but I don't think the table works well in the html - it's a very long table, you can't scroll through years until you get to the bottom and can't see everything all in one screen. I suggest you just include a link to the excel spreadsheet, as it's easier to get a overall view of it that way.

change to "...for Chronic Obstructive..."

change to "..and an international strategy from..." (GOLD call it a strategy, not a guideline

David wanted a reference for this - is it possible in the html format? If so, use the below

Reference - NHS Health Research Authority. Optimum patient care research database. Available from: https://www.hra.nhs.uk/planning-andimproving-research/application-summaries/research-summaries/opti mum-patient-care-research-database/

insert extra line break please

Please use today's date

this seems unnecessary, please delete

please move this underneath the 'patients with COPD diagnosis' row.

I don't understand the figures in this row - as I understand it, the denominator should be the mean number of COPD patients i.e. for 2000-2004, the numerator for the high risk COPD patients should be smaller than the mean number of COPD patients.

change to "12 months"

Please explain data i.e. presume this is mean (SD)?

Change to "Undiagnosed patients with..."

very wordy - this will now be directly under the demoninator for this, so please change to "Undiagnosed patients with potential COPD that meet high-risk criteria (2+ moderate or 1+ severe exacerbation in baseline period); n (%)"

insert '(duration or pack years)'

suggest moving the IMD rows to the bottom of the table. Keeping all the rows about patients together will improve the readability of the table.

The numbers suggest approx 310 practices are in the analysis, but I thought it was all practices in OPCRD. Am I forgetting something?

insert comma please

presume this should be 'mean (SD)' at the end?

Can you remove the header row and then put 'mean (SD)' after the labels for the 'all patients' and 'patients with COPD diagnosis' rows? On first glance I assumed the data in the 'patients with COPD diagnosis' row were meant to be a subgroup of the 'all patients' row (which it isn't), but I think different formatting would stop others making the same assumption

Even though there is complete data for age, is it worth inserting a 'missing age' row to reflect the protocol and readers can easily see there is no missing data?

Do you know when you will be able to produce these time periods?

figs don't make sense - assume there should be a decimal place?

"...12m, mean (SD)"

"...12m, mean (SD)"

this should be "follow-up".

For consistency, change whole label to "Number of…. 12m, mean (SD)"

For consistency, change to "Number of.... 12m, mean (SD)"

Same comments as per previous moderate exacerbations label, and same for antibiotic label

change to "...12m, mean (SD)"

change to "...12m, mean (SD)"

change to "...baseline 12m, mean (SD)"

Also, need to define moderate exacerbations e.g. "(prescription of oral corticosteroid or antibiotic)". Without this, the next 2 rows don't really make sense. Did you use the

I know the first para is taken straight from the protocol, but I think my edits improve clarity.

add "with respiratory consultation ± 3 days"

change to "(after removal of duplicates in same..."

sane comment as for BMI

Label cut points aren't quite right and need to include unit of measurement. Please alter to: <18.5kg/m2, 18.5 - 24.9kg/m2, 25.0 - 29.9kg/m2, 30.0kg/m2 or above (all squared symbols need superscript

meaning? 5yrs before index? 5yrs after index? 5yrs around index?

Typical ordering of categories is: current / ex / never. Is is possible to re-order this?

Is there a way of populating the undiagnosed cell for this row, with "0 (0.0)" or "-"? Just to make clear there's no data

Suggest using 1 decimal place throughout. No need to 2dp level of accuracy

Please change this and all subsequent 'N' to "n". Convention is that 'N' = denominator, and 'n' = numerator

Change to "Sex, n (%) female"

change this and next row to "Age at index..."

Suggest changing to "...described by patient cohort (undiagnosed...)"

Suggest ordering in the same way as rest of report e.g. already / newly / undiagnosed

Need to add apostrophe: Patients'

For the undiagnosed group, have you excluded meds with 3mth duration? (David Halpin's comment from last UK steering committee)

We discussed including extra data on this graph, resulting in 4 lines in total. The extra data needed were:

• % undiagnosed patients that had spiro
• % undiagnosed patients with spiro that had normal lung function

Also, are you able to increase the time period as per David's suggestion (3mths pre-diagnosis and 12mths after diagnosis)?

When will you be able to add this extra data?

I'm not sure how to 'pin' the comments so they don't get minimised each time I click on the report itself. Is this possible?

My new comment - can you see it?