This is a reference period record: For each record instance, the following dates (consisting of month and year) must be captured:
Begin date specifies the begin of the period to which
the question refers
End date specifies the end of the period to which the
question refers
At baseline, the period should range over the last 12 months before the date of entry; at follow-ups, it should range from the last update to the date of entry. See the introduction for more information.
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: | 12.00 |
| Usage in other datasets: | DMD |
This record contains details for the hospitalisations that match the criteria specified in Hospitalisation occurred (inpatient treatments with an overnight stay).
At baseline, details for all hospitalisations in the past 12 months should collected. At subsequent updates, all hospitalisations since the last entry should be collected, while keeping any previously entered data.
The time period for this record must match the time period in the record Hospitalisation period. In case a different time period is used in the record Hospitalisation period (for example, if it is asked whether there have been any hospitalisations in the 24 months before the baseline entry, instead of only 12), all hospitalisations during that period must be collected.
Since version 2.1 this record is longer longitudinal and the item Hospitalisation admission date was added instead.
Type of hospitalisation.
The quoted definition of acute care is taken from Hirshon 2013.
| Item type: | single selection |
| Related items in previous version: | 12.01 |
| Usage in other datasets: | DMD |
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: | 12.03 |
| Usage in other datasets: | DMD |
This item was specified as “Number of days in hospital” in version 1. Due to the ambiguity, it has been changed in version 2.0 to designate the number of nights spent in hospital. In a registry that had previously collected this information in way that is related to the number of nights in a predictable way (for example, if a form asks for the number of started days, this would consistently be the number of nights plus one), the data should be converted accordingly.
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: | 12.04 |
| Usage in other datasets: | DMD |
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 |
| Related items in previous version: | 12.04 |
| Usage in other datasets: | DMD |
| Value ID | Description |
|---|---|
| ICD-10 | ICD-10 |
| ICD-11 | ICD-11 |
| MedDRA | MedDRA |
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: | 12.05 |
| Usage in other datasets: | DMD |
The values Other orthopaedic surgery and Other reason and the related free-text fields were removed from the dataset in version 2.0. However, registries may include them in their data collection forms as noted above. Furthermore, the values Administration of Spinraza and Administration of other disease-modifying treatment for SMA (specify, free text) were removed in version 2.0 and replaced by Disease-modifying therapy as the type of therapy is already collected in the record DMT episode. Moreover, the values Surgical treatment of contractures and Checkup were added.
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:
| Item type: | yes/no |
| Related items in previous version: | 12.06 |
| Usage in other datasets: | DMD |
Disease-modifying therapy to which this SAE was related.
| Item type: | single selection |
| Related items in previous version: | 12.06 |
| Usage in other datasets: | DMDDMD |
| Value ID | Description |
|---|---|
| Nusinersen | Spinraza (nusinersen) |
| Onasemnogene abeparvovec | Zolgensma (AVXS-101) |
| Risdiplam | Evrysdi (risdiplam) |
In version 2.0, the option “Other (specify, free text)” was removed because additional disease-modifying therapies will be added in future versions of the dataset when they become available.
This is a reference period record: For each record instance, the following dates (consisting of month and year) must be captured:
Begin date specifies the begin of the period to which
the question refers
End date specifies the end of the period to which the
question refers
At baseline, the period should range over the last 12 months before the date of entry; at follow-ups, it should range from the last update to the date of entry. See the introduction for more information.
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.
This item applies only to comorbidities that have not been recorded in Hospitalisation acute reason code as the reason for a hospitalisation.
If the value of this item is Yes, details on each comorbidity during that period must be specified in instances of the record Comorbidity.
| Item type: | yes/no |
| Related items in previous version: | 12.10 |
| Usage in other datasets: | DMDLGMD |
This is an episode record: For each record instance, the following dates must be captured:
Start date: The month and year when the condition
described by the record started to hold, if known
Stop date: The month and year when the condition
ceased to hold, if applicable and known
Ongoing date: The month and year on which the
condition was known to hold, if applicable
See the introduction for more information.
This record contains details for comorbidities that held during the reference periods specified in Comorbidities period.
The start date of the episode must be the date of the diagnosis of the comorbidity specified in Comorbidity code, if known. The stop date of the episode must be the end of the symptoms of the comorbidity.
Note that the start and stop dates of comorbidity episodes may extend over multiple reference periods. For example, a comorbidity that held during the 12 months before the baseline entry may have been diagnosed many years earlier. Furthermore, a comorbidity that was entered at baseline may still hold at follow up; in this case, the Ongoing date of the episode already entered should be updated to the date of the follow up.
| Related items in previous version: | 12.12, 12.13 |
In version 2.1, it was clarified that the collection of details of all comorbidities that held during the reference periods specified in Comorbidities period is also mandatory for patient-reported registries.
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.
| Item type: | restricted text |
| Related items in previous version: | 12.11 |
| Usage in other datasets: | DMDLGMD |
As of version 2.0, it is no longer possible to use the ICD-10 chapter headings instead of specific codes. However, registries are free to offer common comorbidities in their data collection form which are automatically mapped to their respective codes.
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: | 12.11 |
| Usage in other datasets: | DMDLGMD |
| Value ID | Description |
|---|---|
| ICD-10 | ICD-10 |
| ICD-11 | ICD-11 |
| MedDRA | MedDRA |
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:
| Item type: | yes/no |
| Related items in previous version: | 12.14 |
| Usage in other datasets: | DMD |
Disease-modifying therapy to which this SAE was related.
| Item type: | single selection |
| Related items in previous version: | 12.15 |
| Usage in other datasets: | DMDDMD |
| Value ID | Description |
|---|---|
| Nusinersen | Spinraza (nusinersen) |
| Onasemnogene abeparvovec | Zolgensma (AVXS-101) |
| Risdiplam | Evrysdi (risdiplam) |
In version 2.0, the option “Other (specify, free text)” was removed because additional disease-modifying therapies will be added in future versions of the dataset when they become available.