3.2 Dataset description
Required |
Repeatable |
|---|---|
Yes |
No |
Definition:
A description containing easily read and understood information about the data asset. The purpose is to enable users not involved in the original study to find, categorise and evaluate the fitness of a data asset to their needs.
Important: The Dataset Description should not simply be a description of the clinical trial.
The dataset description should include:
The basic descriptives of the sample population
The assessment stage/ time point(s)
Which data types are included
The file format
for that individual data asset.
Metadata fields:
Example DataCite XML
<descriptions>
<description xml:lang="en" descriptionType="Abstract"> Haemoglobin levels observed in blood samples of 100 trial participants ( adolescents aged 12-18 years, 63 males /37 females) in the intervention group of the EXEMPLAR study. Timepoints include 1 hour, 3 hours, and 6 hours post dose. Data includes demographics and family medical history in addition to levels of haemoglobin (g/dl) and hematocrit (millions/mm3). The file type is .XLS. </description> </descriptions>
DataCite 17 Description
Occurrences: 1
Input type: Text
Example input:
Haemoglobin levels observed in blood samples of 100 trial participants ( adolescents aged 12-18 years, 63 males /37 females) in the intervention group of the EXEMPLAR study. Timepoints include 1 hour, 3 hours, and 6 hours post dose. Data includes demographics and family medical history in addition to levels of haemoglobin (g/dl) and hematocrit (millions/mm3). The file type is .XLS.
Controlled vocabulary source: Nil
Notes:
Examples of information to include:
Basic descriptives:
Sample size (i.e. in the dataset, especially if this is different from the total number of trial participants)
Age range
Sex characteristics (e.g. number of females vs males vs other)
Breakdown of disease vs healthy, intervention vs control, etc where applicable
Assessment stage/Timepoints, e.g.:
“Baseline data only”
“Follow-up data collected at 3, 6 and 12 months”
Data types:
For example: “demographics”, “family medical history”, “coronal T1-weighted MRI images”
This should be general in nature (e.g. ‘blood pressure’ rather than systolic BP, diastolic BP). More detailed, variable-level descriptions should be provided via the study protocol and/or data dictionary)
File format:
File type (e.g., CSV, XLS, PDF, XML, DICOM. Note: use file extension or MIME type where possible)
Any other technical or formatting information about the file(s) that may be important to someone when opening or working on the file(s). E.g. “Four DICOM files per subject (620 in total), total size >5TB”
Please ensure that this is the description of the dataset and not the trial. For clarity, please refer to the following comparison:
Comparison 1:
Dataset description ✓
This dataset includes 384 participants (from 18 years old, 190 males / 194 females) receiving in-centre or home-based hemodialysis or peritoneal dialysis recruited into the EXEMPLAR study from six local health districts in the Greater Sydney region, New South Wales, Australia. Baseline data includes demographics, dialysis history, cognitive status, health literacy and self-efficacy scores. Follow-up data was collected at 3, 6 and 12 months and includes patient reported outcomes (quality of life, knowledge, confidence, health behaviour and self-management) and clinical outcomes (symptom burden (Palliative care Outcome Scale) and nutritional status (Patient-generated Subjective Global Assessment). The file type is .XLS.
Trial description ✗
The purpose of this study is to investigate whether the EXEMPLAR App supports adults with chronic kidney disease to make decisions about their health, and helps increase knowledge, skills and quality of life. We developed this smartphone App to support participation in decision-making for adults with stage 5 chronic kidney disease who are currently receiving haemodialysis. It includes information about:
Diet
Fluids
Physical activity
Medicines
Emotional wellbeing
Supportive care
Health literacy skills
The procedure for enrolling a subject includes: Participants dialysis at home will be randomised centrally using simple randomisation. It is not feasible to randomise patients individually when attending in-centre dialysis given likely intervention contamination (where the intervention is experienced by controls as well as those allocated the intervention) when control and intervention participants dialyse in the same room three times each week for several hours. However, in-centre patients always attend on the same days; patients either dialyse on Monday, Wednesday and Friday (MWF) or Tuesday, Thursday and Saturday (TTS). We will therefore use a pragmatic approach by randomising the pattern of attendance, not the patient; by centre, all participants attending MWF would be randomly assigned to the EXEMPLAR intervention, or not.
Comparison 2:
Dataset description ✓
This two-arm, parallel, single-blind RCT with blinded follow-up at 4 and 12 months post study entry, conducted in Sydney, Australia, examined the efficacy of an integrated trauma-focused cognitive-behavioural treatment for traumatic stress and substance use among adolescents (‘EXEMPLAR’), relative to a supportive counselling control condition (Person-Centred Therapy (PCT)).
Participants (100 adolescents aged 12-18 years, both males and females) and their caregivers (caregiver participation is optional) were allocated to undergo either EXEMPLAR or PCT (allocation ratio 1:1) using minimisation. Both therapies were delivered individually by project psychologists over a maximum of 16 sessions of 60-90 min duration and included provision of up to four 30 min optional caregiver sessions. The primary outcome is between-group differences in change in the severity of PTSD symptoms from baseline to 4-month follow-up, as measured by the Clinician-Administered PTSD Scale for Children and Adolescents for DSM-5. In addition to these outcomes, the dataset contains the participants’ demographic data and medication history. The file type is .CSV.
Trial description ✗
EXEMPLAR is an integrated psychological therapy targeting substance use and traumatic stress among adolescents. The therapy will be delivered one-on-one by registered psychologists employed on the project over a maximum of 16 weekly, 60-90 minute, face-to-face sessions. The number of sessions will be based on the psychologist’s professional judgement of progress and participants’ preferences.
The EXEMPLAR program has been adapted from the efficacious adult therapy (John et al., 2012;) to meet the developmental needs of adolescents. EXEMPLAR comprises gold standard cognitive-behavioural techniques (CBT) for traumatic stress and substance use, including imaginal and in vivo exposure.
Adolescent participants will have the option of nominating a caregiver to undertake an optional caregiver component. Nominated caregivers who agree to participate will be offered a maximum of four, 30 minute, individual sessions with the adolescent’s psychologist. over the course of the adolescents’ therapy. The number of sessions will be at the caregivers discretion.
Caregiver sessions will comprise psychoeducation about substance use and trauma responses, a rationale for the adolescent program, information about how the caregiver can best support the adolescent through therapy, progress review, and discussion of relapse prevention strategies and aftercare.
Therapy sessions will be conducted at times and locations convenient to the participant and employ flexible scheduling to minimise logistical barriers to attendance. Participants will also be reminded of scheduled appointments the day prior (e.g., via phone, text message, email). Therapists will keep a log of adolescent and caregiver session attendance.
DataCite 17.a descriptionType
Occurrences: 1
Input type: Text
Example input:
Must be “Abstract”
Controlled vocabulary source:
Abstract
Methods
TableOfContents
TechnicalInfo
Other
Notes: