Data Extraction Form for all full text included articles
Study Description
Authors and Year:
Title:
Location:
Peer reviewed (y/n):
State research question:
Sleep is primary are of interest/outcome for the study (y/n):
Population
AS or nr-axSpA:
Method for classification of AS/nr-axSpA:
Sleep Data
Sleep measure utilised (JSEQ, MOS):
Baseline sleep data collected (y/n):
Subjective / Objective sleep data:
Is the scale of measurement validated in a relevant clinical population (y/n):
Is description of methodology clear? (y/n):
Comments:
Study Design
Experimental design type (RCT, Cohort etc):
Appropriate design? (y/n):
Transparency/clarity (y/n):
Group randomisation (y/n):
Blind assessment (y/n):
Groups treated equally (other than intervention) (y/n):
Intervention adherence:
Sample size (N):
Description of any intervention:
Groups (1 : 2 : 3):
N (group 1), male : female (group 1), recruitment (group 1)
N (group 2), male : female (group 2), recruitment (group 2):
N (group 3), male : female (group 3), recruitment (group 3):
Attrition:
Setting:
Follow up on patients:
Selection bias?:
Exclusions:
Ethics noted:
Conflict of interest / author affiliations stated:
Comments on benefit/harm:
Comments on validity, reliability, bias:
limitations noted:
Confidence in results / fit with other findings?:
Comments:
Participant Characteristics
Age (whole cohort):
Age (experimental group):
Disease duration (whole cohort):
Co-morbidities noted:
Medications of participants noted:
Confounding factors noted including: smoking, education, occupation, exercise habit:
Other factors: genetic, environmental, socioeconomic:
Differences between groups in baseline characteristics:
Main findings
All outcomes measured:
Summary of main findings:
Evidence for selective reporting of findings:
Mean/Median, Standard Deviation/IQ Range stated
Statistical analysis used:
Correlation CO-efficient, p value, effect size:
Other stats reported (e.g. multiple regression analysis):
Clinical significance/implications for practice:
Critical Appraisal Questions followed for RCT STUDIES
Does the study address a clearly focused issue:
1.Has the diagnosis of AS or nr-axSpA been confirmed by a clinically acceptable method?
2.Is sleep the primary focus of interest for the study?
Quality of data:
3.Is the quantity and quality of sleep data sufficient for inclusion? For example, is there more than one questionnaire question relating to sleep and is this data relevant for the research question? (Personal opinion)
4.Has the measure of sleep used been validated in a relevant population (rheumatic/arthritic conditions or chronic pain)?
Study design:
5.Were the participants and study personnel blinded?
6.Were the groups similar at the start of the trial?
7.Were the groups treated equally (except for intervention)?
8.Were all participants who started the trial properly accounted for at its conclusion?
Variables and Independent differences:
9.Did the study state clear exclusion criteria?
10.Did the study design control for any other variables (such as exercise, medication, psychological status) other than co-morbidities?
Outcomes:
11.Were the benefits worth the costs? (Personal opinion)
12.Were clinically important outcomes considered? (Personal opinion)
13.Are the results obtained reliable, do you have confidence in their conclusions? (Personal opinion)
14.Does the trial have external validity? Can the results be applied to the wider population of patients with nr-SpA / AS? (Personal opinion)
Critical Appraisal Questions followed for CASE CONTROL and COHORT STUDIES:
Does the study address a clearly focused issue:
1.Has the diagnosis of AS or nr-axSpA been confirmed by a clinically acceptable method?
2.Is sleep the primary focus of interest for the study?
Quality of data:
3.Is the quantity and quality of sleep data sufficient for inclusion? For example, is there more than one questionnaire question relating to sleep and is this data relevant for the research question?(Personal opinion)
4.Has the measure of sleep used been validated in a relevant population (rheumatic/arthritic conditions or chronic pain)?
Study design:
5.Were participants / control subjects recruited in an acceptable way that avoids selection bias?
6.Does the study design include an appropriate control or reference group?
7.Was the study longitudinal, involving the collection of suitable baseline and/or follow up sleep data?
8.Were all participants who started the trial properly accounted for at its conclusion?
Variables and Independent differences:
9.Did the study state clear exclusion criteria?
10.Did the study design control for any other variables (such as exercise, medication, psychological status) other than co-morbidities?
Outcomes:
11.Were the benefits worth the costs? (Personal opinion)
12.Were clinically important outcomes considered? (Personal opinion)
13.Are the results obtained reliable, do you have confidence in their conclusions? (Personal opinion)
14.Does the trial have external validity? Can the results be applied to the wider population of patients with nr-SpA / AS? (Personal opinion)
Critical Appraisal Questions for QUALITATIVE STUDIES:
Does the study address a clearly focused issue:
1.Has the diagnosis of AS or nr-axSpA been confirmed by a clinically acceptable method?
2.Is sleep the primary focus of interest for the study?
Quality of data:
3.Is the quantity and quality of sleep data sufficient for inclusion? For example, is there more than one questionnaire question relating to sleep and is this data relevant for the research question? (Personal opinion)
4.Has the measure of sleep used been validated in a relevant population (rheumatic/arthritic conditions or chronic pain)?
Study design:
5.Were participants recruited in an acceptable way that avoids selection bias?
6.Is qualitative methodology appropriate for this study? (Personal opinion)
7.Was there a suitable method/structure for collecting the data? (Personal opinion)
8.Was the setting and/or relationship with the researcher considered in the study?
9.Is there clear description of qualitative analysis of data?
Variables and Independent differences:
10.Did the study design control for any other variables (such as exercise, medication, psychological status) other than co-morbidities?
Outcomes:
11.Were the benefits worth the costs? (Personal opinion)
12.Were clinically important outcomes considered? (Personal opinion)
13.Are the results obtained reliable, do you have confidence in their conclusions? (Personal opinion)
14.Does the trial have external validity? Can the results be applied to the wider population of patients with nr-SpA / AS? (Personal opinion)