Hospitalisations and comorbidities

Record

Hospitalisation period         reference period 

Hospitalisation occurred

Specifies whether the individual has been admitted to hospital as an inpatient (that is, with an overnight stay) for any reason (irrespective of circumstances or connection to their SMA) and for any duration, sometime during the period from Begin date to End date. Note that these dates do not specify the begin and end of a hospitalisation; they only define the period to which this item applies. An inpatient stay in a rehabilitation hospital is to be included in this item and in the record Hospitalisation. If the value of this item is Yes, the details of all hospitalisations must be collected in instances of the record Hospitalisation.

Item type: yes/no
Related items in previous version: 16.01
Usage in other datasets: SMA
Record

Hospitalisation          

Hospitalisation type

Type of hospitalisation.

The quoted definition of acute care is taken from Hirshon 2013.

Item type: single selection
Related items in previous version: 16.02
Usage in other datasets: SMA
Value ID Description
Planned

Planned (admission was scheduled in advance, e.g. planned surgery, scan, or administration of treatment)

Acute

Acute (admission was in response to a “sudden, often unexpected, urgent or emergent episode of injury and illness that can lead to death or disability without rapid intervention”)

Hospitalisation admission date

Admission date of this hospitalisation.

Item type: date
Related items in previous version: 16.06, 16.12
Usage in other datasets: SMA
Hospitalisation nights

Number of nights the individual spent in hospital during this hospitalisation.

Item type: integer
Consistency rules:

Value must be positive

Related items in previous version: 16.07, 16.13
Usage in other datasets: SMA
Hospitalisation acute reason code

Main reason for this hospitalisation as a code in the classification specified in Hospitalisation acute reason classification. This item is intended mainly for acute hospitalisations and must be collected if Hospitalisation type is Acute. However, it may also be provided if Hospitalisation type is Planned, if an emergency occurred during the planned hospitalisation which would otherwise have required an acute hospitalisation.

Registries, in particular patient-reported ones, may provide users with a list of predefined reasons which are mapped to their respective codes.

Item type: restricted text
Related items in previous version: 16.10, 16.11
Usage in other datasets: SMA
Hospitalisation acute reason classification

Classification used for the value of Hospitalisation acute reason code. If a registry collects codes using a fixed classification, it is not required to collect the classification explicitly from the user; in this case, a fixed value for this item may be used instead.

Item type: single selection
Consistency rules:

Must be provided in case Hospitalisation acute reason code is provided.

Related items in previous version: 16.10
Usage in other datasets: SMA
Value ID Description
ICD-10

ICD-10

ICD-11

ICD-11

MedDRA

MedDRA

Hospitalisation planned reason

Main reason for this hospitalisation. This item is only applicable to planned hospitalisations and must be collected only if Hospitalisation type is Planned.

In addition to the values listed for this item, registries may add further options in their data collection forms if relevant locally, and/or provide a free text field. However, additional options not specified in this dataset must not be provided in a data submission for a TREAT-NMD enquiry. Future revisions of this dataset may include additional values, and these can be suggested (along with justification) by using the “Report an issue with this item” function.

Item type: single selection
Related items in previous version: 16.03
Usage in other datasets: SMA
Value ID Description
G-tube placement

Placement of g-tube

Sleep study

Sleep study

Scoliosis surgery

Scoliosis surgery

Hip surgery

Hip surgery

Contracture surgery

Surgical treatment of contractures

Disease-modifying therapy

Administration of disease-modifying therapy

Checkup

Routine checkup

Hospitalisation SAE

Specifies whether the reason for the hospitalisation specified in Hospitalisation acute reason code was classed as a serious adverse event (SAE) in relation to a disease-modifying therapy.

Registries should clearly inform the data provider that completing this data item does not replace the need to report SAEs immediately via their local reporting mechanisms.

SAE = Serious Adverse Event. “Any untoward medical occurrence that at any dose:

  • results in death,
  • is life-threatening (NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.
  • requires inpatient hospitalisation or prolongation of existing hospitalisation,
  • results in persistent or significant disability/incapacity, or
  • is a congenital anomaly/birth defect.”

(EMA ICH E2A)

Item type: yes/no
Related items in previous version: 16.14
Usage in other datasets: SMA
Hospitalisation SAE DMT

Disease-modifying therapy to which this SAE was related.

Item type: single selection
Related items in previous version: 16.15
Usage in other datasets: SMASMA
Value ID Description
Ataluren

Ataluren (Translarna)

Casimersen

Casimersen (Amondys 45)

Eteplirsen

Eteplirsen (Exondys 51)

Golodirsen

Golodirsen (Vyondys 53)

Viltolarsen

Viltolarsen (Viltepso)

Record

Comorbidities period CR  PR      reference period 

Comorbidities diagnosed CR  PR 

Specifies whether the individual has been diagnosed with other comorbidities during the period from Begin date to End date. This includes any comorbidities diagnosed earlier than Begin date which still held during this period. In this context comorbidities are defined as any additional medical conditions occurring alongside the neuromuscular condition.

Item type: yes/no
Related items in previous version: 16.19
Usage in other datasets: SMALGMD
Record

Comorbidity CR      episode   

Related items in previous version: 16.20
Comorbidity code CR 

Comorbidity as code of the classification specified in Comorbidity classification. Registries, in particular patient-reported registries, may provide common comorbidities as a list in their data collection forms or have users enter the diagnosis in a free-text field which is then coded by a curator.

It is recommended that registries use a dropdown menu or radio buttons containing at least the following diagnoses:

Diagnosis ICD-10 code
Steroid-related comorbidities:
Cataract H26.3
Obesity E66.1
Hypertension I15.8
Delayed puberty E30.0
Diabetes E14
DMD-related comorbidities:
Autism F84.0
ADHD F90.0

If any of these options is selected, the value of this item must then be the respective ICD-10 code given above (and Comorbidity classification must have the value ICD-10). Additional or more specific pre-selected diagnoses may be provided. In order to collect other unlisted diagnoses, registries should allow entering an ICD-10 code (for clinician-reported registries) or offer a free-text field that is manually mapped to an ICD-10 code by a curator (for patient-reported registries).

Item type: restricted text
Related items in previous version: 16.20, 16.21
Usage in other datasets: SMALGMD
Comorbidity classification CR 

Classification used in the item Comorbidity code. The list of possible values may be amended in future versions of the dataset to enable the use of codes present only in local ICD-10 modifications.

Item type: single selection
Related items in previous version: 16.20, 16.21
Usage in other datasets: SMALGMD
Value ID Description
ICD-10

ICD-10

ICD-11

ICD-11

MedDRA

MedDRA

Comorbidity SAE

Specifies whether this comorbidity was classed as a serious adverse event (SAE) in relation to a disease-modifying therapy.

Registries should clearly inform the data provider that completing this data item does not replace the need to report SAEs immediately via their local reporting mechanisms.

SAE = Serious Adverse Event. “Any untoward medical occurrence that at any dose:

  • results in death,
  • is life-threatening (NOTE: The term "life-threatening" in the definition of "serious" refers to an event in which the patient was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe.
  • requires inpatient hospitalisation or prolongation of existing hospitalisation,
  • results in persistent or significant disability/incapacity, or
  • is a congenital anomaly/birth defect.”

(EMA ICH E2A)

Item type: yes/no
Related items in previous version: 16.22
Usage in other datasets: SMA
Comorbidity SAE DMT

Disease-modifying therapy to which this SAE was related.

Item type: single selection
Related items in previous version: 16.23
Usage in other datasets: SMASMA
Value ID Description
Ataluren

Ataluren (Translarna)

Casimersen

Casimersen (Amondys 45)

Eteplirsen

Eteplirsen (Exondys 51)

Golodirsen

Golodirsen (Vyondys 53)

Viltolarsen

Viltolarsen (Viltepso)