oxford-pharmacoepi / bsshstudyathon2021 Goto Github PK

for all collaborators, it would be great to be able to introduce you in the European morning and to explain who you are!

Pre-index characteristics
These features will be described as assessed in two different time windows: the last 30 days (-1 to -30 days) and the year (-1 to -365 days) pre-index:
Demographics:

• Age: calculated as year of cohort start date – year of birth and with 5 year groupings
• Sex
• Race
  -Measures of comorbidity (such as Charlson comorbidity index or isolated comorbidities of interest)
  Concept-based:
• Condition groups (SNOMED + descendants), >=1 occurrence during the interval
• Drug era groups (ATC/RxNorm + descendants), >=1 day during the interval which overlaps with at least 1 drug era
  Cohort-based: (to be added if relevant from lists)

Persons in secondary target cohorts:
For cohorts by disease aetiology: Idiopathic
● have a record of a first surgery for wrist arthritis (index event)
● have a record of Kienbocks or Preisers disease any time prior to and including the date of the index event

• Initial draft of cohort
• Run on sites
• Modifications per site or clinical input

what would bring the most interesting discussion after Dr Graham's presentation:

Is the question appropriate?
How we show that we're not interested in data mining?
Statistical significance?
How do we confirm this is clinically relevant work?
How do we best discuss limitations?

Going forward, what data would be most useful in order to augment routinely collected data

Persons in secondary target cohorts:
For cohorts by disease aetiology: Crystalline deposition (gout, pseudogout)
● have a record of a first surgery for wrist arthritis (index event)
● have a record of gout or pseudogout any time prior to and including the date of the index event

• Initial draft of cohort
• Run on sites
• Modifications per site or clinical input

• UCSF (Rohit)
• JHMI (Mary Grace/Paul)
• Columbia (Thomas)
• CPRD (Jenny)
• IQVIA (TBD)

Persons in secondary target cohorts:
For cohorts by surgical intervention: Wrist (AIN/ PIN) denervation
● have a record of a first wrist denervation (index event)

• Initial draft of cohort
• Run on sites
• Modifications per site or clinical input

• UCSF (Rohit)
• JHMI (Mary Grace/Paul)
• Columbia (Thomas)
• CPRD (Jenny)
• IQVIA (TBD)

Persons in secondary target cohorts:
For cohorts by surgical intervention: Total Wrist fusion
● have a record of a first wrist fusion (index event)

• Initial draft of cohort
• Run on sites
• Modifications per site or clinical input

Persons in secondary target cohorts:
For cohorts by surgical intervention: PWA – partial wrist arthrodesis (will capture RSL, RL, other midcarpal fusions)
● have a record of a first partial wrist arthrodesis (index event)

• Initial draft of cohort
• Run on sites
• Modifications per site or clinical input

Persons in secondary target cohorts:
For cohorts by disease aetiology: SNAC
● have a record of a first surgery for wrist arthritis (index event)
● have a record of SNAC any time prior to and including the date of the index event

• Initial draft of cohort
• Run on sites
• Modifications per site or clinical input

Create a cohort definitions for:

• Wound infection requiring antibiotics
• Wound infection requiring surgical management
• Deep surgical site infection including septic arthritis
• Neurovascular injury
• Tendon injury
• Fracture
• Prominent metalwork
• Reoperation
• Non-union

• one long meeting 0900-1700 to enable observers?
  if so- need to generate this and then send to faculty to ensure they know how to join

Persons in secondary target cohorts:
For cohorts by disease aetiology: SLAC
● have a record of a first surgery for wrist arthritis (index event)
● have a record of SLAC any time prior to and including the date of the index event

• Initial draft of cohort
• Run on sites
• Modifications per site or clinical input

Persons in the main target cohort for all surgically managed wrist arthritis will:
● have a record of a first surgery for wrist arthritis (index event)

• Initial draft of cohort
• Run on sites
• Modifications per site or clinical input

Persons in secondary target cohorts:
For cohorts by surgical intervention: wrist arthroplasty
● have a record of any form of wrist arthroplasty (including total wrist and pyrocarbon interposition if identifiable) (index event)

• Initial draft of cohort
• Run on sites
• Modifications per site or clinical input

Persons in secondary target cohorts:
For cohorts by disease aetiology: Rheumatoid arthritis
● have a record of a first surgery for wrist arthritis (index event)
● have a record of rheumatoid arthritis any time prior to and including the date of the index event

• Initial draft of cohort
• Run on sites
• Modifications per site or clinical input

Persons in secondary target cohorts:
For cohorts by surgical intervention: Radial styloidectomy
● have a record of a first Radial styloidectomy (index event)

• Initial draft of cohort
• Run on sites
• Modifications per site or clinical input

Cohort-based Medical outcomes:
● Acute kidney injury (AKI) diagnosis during hospitalization
● Acute kidney injury (AKI) using diagnosis codes and change in measurements during hospitalization
● Acute myocardial infarction events
● Angina during hospitalization
● Bleeding during hospitalization
● Bradycardia or heart block during hospitalization
● Cardiac arrhythmia during hospitalization
● Cardiovascular-related mortality
● Death
● Deep vein thrombosis events
● Renal/Dialysis during hospitalization
● Heart failure during hospitalization
● Hemorrhagic stroke (intracerebral bleeding) events
● Hospitalization episodes
● Intensive services during hospitalization
● Ischemic stroke events
● Mechanical ventilation during hospitalization
● Persons with chest pain or angina
● Pneumonia during hospitalization
● Pneumonia episodes
● Pulmonary Embolism events
● Sepsis during hospitalization
● Stroke (ischemic or hemorrhagic) events
● Supraventricular arrythymia during hospitalization
● Total cardiovascular disease events
● Transient ischemic attack events
● Venous thromboembolic (pulmonary embolism and deep vein thrombosis) events
● Ventricular arrhythmia or cardiac arrest during hospitalization

Persons in secondary target cohorts:
For cohorts by surgical intervention: PRC (proximal row carpectomy)
● have a record of a first proximal row carpectomy (index event)

• Initial draft of cohort
• Run on sites
• Modifications per site or clinical input

Persons in secondary target cohorts:
For cohorts by surgical intervention: wrist arthroscopy
● have a record of wrist arthroscopy (index event)
● have a record of SLAC, SNAC, Kienbocks disease, Preisers disease, Rheumatoid arthritis or crystalline deposition any time prior to and including the date of index event

• Initial draft of cohort
• Run on sites
• Modifications per site or clinical input

for Janssen
for JHU (data)
for JHU (surgery)
for CUIMC?
for Univ Cal

Each target cohort will be analysed in full and stratified on factors based on the following pre-index characteristics, all stratum are pending meeting minimum reportable cell counts (as specified by data owners) and where possible, may include:
● Follow-up time: overall, with full 30 days follow-up, without full 30 days follow-up
● Sex (Male vs. Female)
● Those with another type of specified hand surgery prior to index procedure (eg denervation prior to arthrodesis)
● All reportable age groups as well as specifically:
○ Young age ( Age >=35)
○ Elderly (Age >= 65). If sample size allows, results will be reported stratified in the following age categories: 65-84 years, and >=85 years, or in finer age strata (65-69, 70-74, 75-79, 80-84, >=85 years)

Post-index characteristics
These features will be described in two different time windows: at index date (day 0) and in the 30 days from index date (0 to 30 days). As time elapses, additional windows of time will be investigated (eg. in the 90 days from index date [0 to 90 days]) and where possible for some surgical outcomes up to 1 and 5 years following surgery. The characteristics will include:

Concept-based:
● Condition groups (SNOMED + descendants), >=1 occurrence during the interval
● Drug era start groups (ATC/RxNorm + descendants), >=1 drug era start during the interval

Cohort-based Medical outcomes: (See #17)
Cohort-based Surgical outcomes: (See #18)