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.

Type of hospitalisation.

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

Admission date of this hospitalisation.

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

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.

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.

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.

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)

Disease-modifying therapy to which this SAE was related.

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.

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:

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).

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.

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)

Disease-modifying therapy to which this SAE was related.