Extraction form for project: SGS 2022 POP PROM

Design Details

1. Duplicate?
This question will allow you to skip over redundant questions. If the answer is yes, you may be able to skip the Risk of Bias sheet (unless the subscales etc. were assessed with poorer (or more incomplete) methodology than the main scale.
Is this a secondary extraction for a sub-scale of an already extracted scale?
Single Choice
Yes
No
Is this an extraction for a >=2nd PROM from an already extracted article (and the population etc. is the same)?
Single Choice
Yes
No
2. Population (POP eligibility criteria)
Dependency
  • Question Position: 1
    • - Cell: (Is this a secondary extraction for a sub-scale of an already extracted scale? x )
    • - Option: No
    • - Cell: (Is this an extraction for a >=2nd PROM from an already extracted article (and the population etc. is the same)? x )
    • - Option: No
    3. Country
    Dependency
  • Question Position: 1
    • - Cell: (Is this a secondary extraction for a sub-scale of an already extracted scale? x )
    • - Option: No
    • - Cell: (Is this an extraction for a >=2nd PROM from an already extracted article (and the population etc. is the same)? x )
    • - Option: No
    Multiple Choice
    US
    Australia
    Canada
    France
    Germany
    Israel
    Japan
    New Zealand
    Other(s)
    4. Specific setting or location
    Dependency
  • Question Position: 1
    • - Cell: (Is this a secondary extraction for a sub-scale of an already extracted scale? x )
    • - Option: No
    • - Cell: (Is this an extraction for a >=2nd PROM from an already extracted article (and the population etc. is the same)? x )
    • - Option: No
    5. Specific feature that might affect generalizability
    Dependency
  • Question Position: 1
    • - Cell: (Is this a secondary extraction for a sub-scale of an already extracted scale? x )
    • - Option: No
    • - Cell: (Is this an extraction for a >=2nd PROM from an already extracted article (and the population etc. is the same)? x )
    • - Option: No
    6. No. participants analyzed
    7. Age
    Dependency
  • Question Position: 1
    • - Cell: (Is this a secondary extraction for a sub-scale of an already extracted scale? x )
    • - Option: No
    • - Cell: (Is this an extraction for a >=2nd PROM from an already extracted article (and the population etc. is the same)? x )
    • - Option: No
    Low boundHigh bound
    Mean
    Single Choice
    Not Reported
    SD
    Single Choice

    SE
    Single Choice

    95% CI
    Median
    Single Choice

    Interquartile range (IQR)
    Full range (might come from eligibility criteria)
    8. POP-Q, %
    0-100% (not proportion 0-1)
    Dependency
  • Question Position: 1
    • - Cell: (Is this a secondary extraction for a sub-scale of an already extracted scale? x )
    • - Option: No
    • - Cell: (Is this an extraction for a >=2nd PROM from an already extracted article (and the population etc. is the same)? x )
    • - Option: No
    Low bound
    NR
    Single Choice
    Not reported
    Stage 0
    Stage 1
    Stages 0-1
    Stage 2
    Stage 3
    Stage 4
    Stages 3-4
    Other POP-Q info
    9. PROM evaluated
    Be specific, particularly for subscales, domains, etc.
    Name of full measure
    Subscale name
    10. Reference(s) for original version of PROM
    If the article references the original version of the PROM (or the creation of the PROM), list the references (either PMID(s) or full reference
    11. Reference(s) for other validations of PROM
    If the article references other articles that validate PROM, list the references (either PMID(s) or full reference
    12. PROM description
    For subscales, etc. can skip if this is all identical to the overall (already-extracted) PROM (of if not relevant). For "List of Domains", please copy and paste the names of the domains, separated by commas. Note that the worst score may be the minimum or maximum score (same for best score).
    No. of items
    No. domains
    List of domains
    If domains, can one report at the domain level
    Single Choice
    Yes
    No
    Unclear
    How is PROM scored (e.g., Likert 1-5 per question)
    "Worst" score
    "Best" score
    How to access/where it is available
    Method(s) of administration in the article
    Multiple Choice
    Electronic
    Paper
    Telephone
    In-person verbally
    Other
    Not reported
    13. Average PROM score in study
    Or subscale/domain/etc. score
    Low boundHigh bound
    Mean
    Single Choice
    Not Reported
    SD
    Single Choice

    SE
    Single Choice

    95% CI
    Median
    Single Choice

    Interquartile range (IQR)
    Full range
    14. Length of time to complete
    Dependency
  • Question Position: 1
    • - Cell: (Is this a secondary extraction for a sub-scale of an already extracted scale? x )
    • - Option: No
    • - Cell: (Is this an extraction for a >=2nd PROM from an already extracted article (and the population etc. is the same)? x )
    • - Option: No
    Low boundHigh bound
    Mean
    Single Choice
    Not Reported
    SD
    Single Choice

    SE
    Single Choice

    95% CI
    Median
    Single Choice

    Interquartile range (IQR)
    Full range
    Units
    Single Choice
    Minutes
    Other
    15. Percent of missing PROM scores (or subscale etc. scores)
    0-100% (not 0-1 proportion)
    16. Was CONTENT or FACE VALIDITY assessed?
    You can use the f/up question text box if you have a comment about this question
    Single Choice
    Yes
    No
    17. Content/Face validity, per authors
    Did the authors claim content or face validity? Copy and paste relevant text.
    Dependency
  • Question Position: 16
    • - Option: Yes
    Y/N
    Single Choice
    Yes (claimed structural validity)
    No (claimed no structural validity)
    ? (no claim or unclear)
    Article text
    Note/comment
    18. CONTENT/FACE VALIDITY: Extractor comments
    Dependency
  • Question Position: 16
    • - Option: Yes
    19. Was STRUCTURAL VALIDITY assessed?
    You can use the f/up question text box if you have a comment about this question
    Single Choice
    Yes
    No
    20. Structural Validity, data
    The "COSMIN threshold" column is FYI. Do not enter data here.
    Dependency
  • Question Position: 19
    • - Option: Yes
    Value reportedCOSMIN thresholdCriterion met? (eg, beyond threshold)Other info (eg, what was comparator test or subgroups compared)Note/column
    A: Confirmatory factor analysis (CFA)/Unidimensionality: Comparative fit index (CFI)
    Single Choice
    >0.95
    Single Choice
    Yes
    No
    Not reported
    B: CFA/Unidimensionality: Tucker‐Lewis index (TLI)
    Single Choice
    >0.95
    Single Choice
    Yes
    No
    Not reported
    C: CFA/Unidimensionality: other measure comparable to CFI or TLI (name in COSMIN threshold column)
    Single Choice
    >0.95
    Single Choice
    Yes
    No
    Not reported
    D: CFA/Unidimensionality: Root Mean Square Error of Approximation (RMSEA)
    Single Choice
    <0.06
    Single Choice
    Yes
    No
    Not reported
    E: CFA/Unidimensionality: Standardized Root Mean Residuals (SRMR)
    Single Choice
    <0.08
    Single Choice
    Yes
    No
    Not reported
    F: Local independence: Maximum residual correlations among the items after controlling for the dominant factor
    Single Choice
    <0.20
    Single Choice
    Yes
    No
    Not reported
    G: Local independence: Maximum Q3
    Single Choice
    <0.37
    Single Choice
    Yes
    No
    Not reported
    H: Monotonicity: Adequate looking graphs
    Single Choice

    Single Choice

    Single Choice
    Yes
    No
    No relevant graphs
    I: Monotonicity: Item scalability
    Single Choice
    >0.30
    Single Choice
    Yes
    No
    Not reported
    J: Model fit: χ2
    Single Choice
    >0.01
    Single Choice
    Yes
    No
    Not reported
    K: Model fit: Infit mean squares
    Single Choice
    Between 0.5 and 1.5 (inclusive)
    Single Choice
    Yes
    No
    Not reported
    L: Model fit: Outfit mean squares
    Single Choice
    Between 0.5 and 1.5 (inclusive)
    Single Choice
    Yes
    No
    Not reported
    M: Model fit: Z-standardized value
    Single Choice
    Between ‐2 and <2 (exclusive)
    Single Choice
    Yes
    No
    Not reported
    Other info on structural validity
    Single Choice

    Single Choice

    Single Choice

    Single Choice

    21. Structural validity, per Classical Test Theory (CTT)
    Add comments in the follow-up question, if you'd like
    Dependency
  • Question Position: 19
    • - Option: Yes
    Single Choice
    Yes (Any of A or B or C or D or E true)
    No (None of A to E are true)
    ? (A-E not or incompletely reported)
    22. Structural validity, per Item Response Theory (IRT)/Rasch
    Dependency
  • Question Position: 19
    • - Option: Yes
    Single Choice
    Yes (CTT (A-E) and (F or G) and (H or I) and (J or (K and L) or M))
    No (Criteria for ‘Yes’ not met)
    ? (Model fit not or incompletely reported)
    23. Structural validity, per authors
    Did the authors claim structural validity? Copy and paste relevant text.
    Dependency
  • Question Position: 19
    • - Option: Yes
    Y/N
    Single Choice
    Yes (claimed structural validity)
    No (claimed no structural validity)
    ? (no claim or unclear)
    Article text
    Note/comment
    24. STRUCTURAL VALIDITY: Extractor comments
    Dependency
  • Question Position: 19
    • - Option: Yes
    25. Was INTERNAL CONSISTENCY assessed?
    You can use the f/up question text box if you have a comment about this question
    Single Choice
    Yes
    No
    26. Internal consistency, data
    The "COSMIN threshold" column is FYI. Do not enter data here.
    Dependency
  • Question Position: 25
    • - Option: Yes
    Value reportedCOSMIN thresholdCriterion met? (eg, beyond threshold)Other info (eg, what was comparator test or subgroups compared)Note/column
    N: Sufficient structural validity
    Single Choice

    Single Choice
    Yes (at least low evidence)
    No
    O: Cronbach's alpha(s) (for each unidimensional scale or subscale)
    Single Choice
    ≥0.70
    Single Choice
    Yes
    No
    Not reported
    Other info on internal consistency
    Single Choice

    Single Choice

    Single Choice

    Single Choice

    27. Internal consistency
    Dependency
  • Question Position: 25
    • - Option: Yes
    Single Choice
    Yes (Both N and O met)
    No (Neither N nor O met)
    ? (only O met)
    28. Internal consistency, per authors
    Did the authors claim internal consistency? Copy and paste relevant text.
    Dependency
  • Question Position: 25
    • - Option: Yes
    Y/N
    Single Choice
    Yes (claimed internal consistency)
    No (claimed no internal consistency)
    ? (no claim or unclear)
    Article text
    Note/comment
    29. INTERNAL CONSISTENCY: Extractor comments
    Dependency
  • Question Position: 25
    • - Option: Yes
    30. Was RELIABILITY assessed?
    You can use the f/up question text box if you have a comment about this question
    Single Choice
    Yes
    No
    31. Reliability, data
    The "COSMIN threshold" column is FYI. Do not enter data here.
    Dependency
  • Question Position: 30
    • - Option: Yes
    Value reportedCOSMIN thresholdCriterion met? (eg, beyond threshold)Other info (eg, what was comparator test or subgroups compared)Note/column
    Type
    Multiple Choice
    Internal consistency
    Test-retest
    Inter-rater
    Intra-rater
    Single Choice

    Single Choice

    Single Choice

    Single Choice

    P: Intraclass correlation coefficient (ICC)
    Single Choice
    ≥0.70
    Single Choice
    Yes
    No
    Not reported
    Q: Weighted kappa
    Single Choice
    ≥0.70
    Single Choice
    Yes
    No
    Not reported
    Other info on reliability
    Single Choice

    Single Choice

    Single Choice

    Single Choice

    32. Reliability
    Dependency
  • Question Position: 30
    • - Option: Yes
    Single Choice
    Yes (Either P or Q met)
    No (Neither P not Q met)
    ? (P and Q not reported)
    33. Reliability, per authors
    Did the authors claim reliability? Copy and paste relevant text.
    Dependency
  • Question Position: 30
    • - Option: Yes
    Y/N
    Single Choice
    Yes (claimed reliability)
    No (claimed no reliability)
    ? (no claim or unclear)
    Article text
    Note/comment
    34. RELIABILITY: Extractor comments
    Dependency
  • Question Position: 30
    • - Option: Yes
    35. Was MEASUREMENT ERROR assessed?
    You can use the f/up question text box if you have a comment about this question
    Single Choice
    Yes
    No
    36. Measurement error, data
    ENTER MIC IN COSMIN COLUMN FOLLOW-UP QUESTION (select the <MIC text first)
    Dependency
  • Question Position: 35
    • - Option: Yes
    Value reportedCOSMIN thresholdCriterion met? (eg, beyond threshold)Other info (eg, what was comparator test or subgroups compared)Note/column
    R: Smallest detectable change (SDC)
    Single Choice
    <MIC (minimal important change)
    Single Choice
    Yes
    No
    Not reported
    S: Limits of agreement (LoA)
    Single Choice
    <MIC (minimal important change)
    Single Choice
    Yes
    No
    Not reported
    Time interval
    Single Choice

    Single Choice

    Single Choice

    Single Choice

    Other info on measurement error
    37. Measurement error
    Dependency
  • Question Position: 35
    • - Option: Yes
    Single Choice
    Yes (Either R or S met)
    No (Neither R nor S met)
    ? (MIC not defined or reliability not reported)
    38. Measurement error, per authors
    Did the authors claim small measurement error? Copy and paste relevant text.
    Dependency
  • Question Position: 35
    • - Option: Yes
    Y/N
    Single Choice
    Yes (claimed small measurement error)
    No (claimed too large measurement error)
    ? (no claim or unclear)
    Article text
    Note/comment
    39. MEASUREMENT ERROR: Extractor comments
    Dependency
  • Question Position: 35
    • - Option: Yes
    40. Was CONSTRUCT VALIDITY assessed?
    You can use the f/up question text box if you have a comment about this question
    Single Choice
    Yes
    No
    41. Construct validity
    Dependency
  • Question Position: 40
    • - Option: Yes
    What is the hypothesis (eg, measure will be lower with improvement in symptoms)
    Type, which comparators? (in f/up Q)
    Multiple Choice
    Convergent (vs. PROM with similar constructs)
    Discriminative (between subgroups)
    Other/unclear
    Construct validity?
    Single Choice
    Yes (The result is in accordance with the hypothesis)
    No (The result is not in accordance with the hypothesis)
    ? (No hypothesis evaluated)
    Supporting data
    42. Construct validity, per authors
    Did the authors claim construct validity? Copy and paste relevant text.
    Dependency
  • Question Position: 40
    • - Option: Yes
    Y/N
    Single Choice
    Yes (claimed construct validity)
    No (claimed no construct validity)
    ? (no claim or unclear)
    Article text
    Note/comment
    43. CONSTRUCT VALIDITY: Extractor comments
    Dependency
  • Question Position: 40
    • - Option: Yes
    44. Was CROSS-CULTURAL VALIDITY/MEASUREMENT INVARIANCE assessed?
    You can use the f/up question text box if you have a comment about this question
    Single Choice
    Yes
    No
    45. Cross‐cultural validity\measurement invariance, data
    The "COSMIN threshold" column is FYI. Do not enter data here.
    Dependency
  • Question Position: 44
    • - Option: Yes
    Value reportedCOSMIN thresholdCriterion met? (eg, beyond threshold)Other info (eg, what was comparator test or subgroups compared)Note/column
    Groups compared/evaluated
    Single Choice

    Single Choice

    Single Choice

    Single Choice

    T: No important differences found between group factors (such as age, gender, language) in multiple group factor analysis
    Single Choice

    Single Choice
    Yes
    No
    Not reported
    U: McFadden's R^2, differential item functioning (DIF) group factors
    Single Choice
    <0.02
    Single Choice
    Yes
    No
    Not reported
    Other info on measurement invariance
    Single Choice

    Single Choice

    Single Choice

    Single Choice

    46. Cross‐cultural validity\measurement invariance
    Dependency
  • Question Position: 44
    • - Option: Yes
    Measurement invariance?
    Single Choice
    Yes (Either T or U met)
    No (Neither T nor U met)
    ? (T and U not reported/evaluated)
    47. Cross‐cultural validity\measurement invariance, per authors
    Did the authors claim measurement invariance? Copy and paste relevant text.
    Dependency
  • Question Position: 44
    • - Option: Yes
    Y/N
    Single Choice
    Yes (claimed measurement invariance)
    No (claimed no measurement invariance)
    ? (no claim or unclear)
    Article text
    Note/comment
    48. CROSS-CULTURAL VALIDITY/MEASUREMENT INVARIANCE: Extractor comments
    Dependency
  • Question Position: 44
    • - Option: Yes
    49. Was CRITERION VALIDITY assessed?
    You can use the f/up question text box if you have a comment about this question
    Single Choice
    Yes
    No
    50. Criterion validity, data
    The "COSMIN threshold" column is FYI. Do not enter data here.
    Dependency
  • Question Position: 49
    • - Option: Yes
    Value reportedCOSMIN thresholdCriterion met? (eg, beyond threshold)Other info (eg, what was comparator test or subgroups compared)Note/column
    Gold standard
    Single Choice

    Single Choice

    Single Choice

    Single Choice

    V: Correlation with gold standard
    Single Choice
    ≥0.70
    Single Choice
    Yes
    No
    Not reported
    W: Area under curve (AUC)
    Single Choice
    ≥0.70
    Single Choice
    Yes
    No
    Not reported
    Other info on criterion validity
    Single Choice

    Single Choice

    Single Choice

    Single Choice

    51. Criterion validity
    Dependency
  • Question Position: 49
    • - Option: Yes
    Measurement invariance?
    Single Choice
    Yes (Either V or W met)
    No (Neither V nor W met)
    ? (V and W not reported/evaluated)
    52. Criterion validity, per authors
    Did the authors claim criterion validity? Copy and paste relevant text.
    Dependency
  • Question Position: 49
    • - Option: Yes
    Y/N
    Single Choice
    Yes (claimed criterion validity)
    No (claimed no criterion validity)
    ? (no claim or unclear)
    Article text
    Note/comment
    53. CRITERION VALIDITY: Extractor comments
    Dependency
  • Question Position: 49
    • - Option: Yes
    54. Was RESPONSIVENESS assessed?
    You can use the f/up question text box if you have a comment about this question
    Single Choice
    Yes
    No
    55. Responsiveness, data
    The "COSMIN threshold" column is FYI. Do not enter data here.
    Dependency
  • Question Position: 54
    • - Option: Yes
    Value reportedCOSMIN thresholdCriterion met? (eg, beyond threshold)Other info (eg, what was comparator test or subgroups compared)Note/column
    Other measures, or treatment, or time period
    Single Choice

    Single Choice

    Single Choice

    Single Choice

    X: The result is in accordance with the hypothesis
    Single Choice

    Single Choice

    Single Choice
    Yes
    No
    Not reported
    Y: Area under curve (AUC)
    Single Choice
    ≥0.70
    Single Choice
    Yes
    No
    Not reported
    Other info on reliability
    Single Choice

    Single Choice

    Single Choice

    Single Choice

    56. Responsiveness
    Dependency
  • Question Position: 54
    • - Option: Yes
    Measurement invariance?
    Single Choice
    Yes (Either X or Y met)
    No (Neither X nor Y met)
    ? (no hypothesis defined)
    57. Responsiveness, per authors
    Did the authors claim criterion validity? Copy and paste relevant text.
    Dependency
  • Question Position: 54
    • - Option: Yes
    Y/N
    Single Choice
    Yes (claimed responsiveness)
    No (claimed no responsiveness)
    ? (no claim or unclear)
    Article text
    Note/comment
    58. RESPONSIVENESS: Extractor comments
    Dependency
  • Question Position: 54
    • - Option: Yes
    59. Was FLOOR/CEILING EFFECT assessed?
    You can use the f/up question text box if you have a comment about this question
    Single Choice
    Yes
    No
    60. Floor/Ceiling effect
    0-100% (not 0-1 proportion)
    Dependency
  • Question Position: 59
    • - Option: Yes
    % with floor value
    % with ceiling value
    NR
    Multiple Choice
    NR
    61. FLOOR/CEILING EFFECT: Extractor comments
    Dependency
  • Question Position: 59
    • - Option: Yes
    62. Was MCID assessed?
    You can use the f/up question text box if you have a comment about this question
    Single Choice
    Yes
    No
    63. MCID reported
    Dependency
  • Question Position: 62
    • - Option: Yes
    MCID value
    How determined?
    64. MCID: Extractor comments
    Dependency
  • Question Position: 62
    • - Option: Yes
    65. Other information about validity, reliability, measurement error, etc.?
    66. Other comments/notes
    67. 2nd review done?
    Add your name when you've completed the second review. Add comments or questions or notes, if necessary
    Name
    Comments

    Risk of Bias Assessment

    1. Constructs assessed
    You need to answer this question to get to the appropriate RoB questions
    Multiple Choice
    Structural validity
    Internal consistency
    Cross-cultural validity/measurement invariance
    Reliability
    Measurement error
    Criterion validity
    Construct validity
    Responsiveness
    MCID
    2. Structural validity/Classical Test Theory: Was exploratory or confirmatory factor analysis performed?
    Dependency
  • Question Position: 1
    • - Option: Structural validity
    Adequacy
    Single Choice
    Very good (Confirmatory factor analysis performed)
    Adequate (Exploratory factor analysis performed)
    Inadequate (No exploratory or confirmatory factor analysis performed)
    N/A (Structural validity/Classical Test Theory not assessed)
    Extractor comment
    3. Structural validity/Item Response Theory/Rasch: Does the chosen model fit to the research question?
    Dependency
  • Question Position: 1
    • - Option: Structural validity
    Adequacy
    Single Choice
    Very good (Chosen model fits well to the research question)
    Adequate (Assumable that the chosen model fits well to the research question)
    Doubtful (Doubtful if the chosen model fits well to the research question)
    Inadequate (Chosen model does not fit to the research question)
    N/A (Structural validity/Item Response Theory/Rasch not assessed)
    Extractor comment
    4. Structural validity: Was the sample size included in the analysis adequate?
    *VERY GOOD*: FA: N≥7 times the number of items, and N≥100 Rasch/1PL models: N≥200 2PL parametric IRT models OR Mokken scale analysis: N≥1000 *ADEQUATE* FA: N at least 5 times the number of items, and N≥100; OR at least 6 times the number of items (if N<100) Rasch/1PL models: N 100‐199 2PL parametric IRT models OR Mokken scale analysis: N 500‐999 *DOUBTFUL* FA: N 5 times the number of items, but N<100 Rasch/1PL models: N 50‐99 2PL parametric IRT models OR Mokken scale analysis: N 250‐499 *INADEQUATE* FA: N<5 times the number of items Rasch/1PL models: N< 50 2PL parametric IRT models OR Mokken scale analysis: N<250
    Dependency
  • Question Position: 1
    • - Option: Structural validity
    Adequacy
    Single Choice
    Very good
    Adequate
    Doubtful
    Inadequate
    N/A (Structural validity not assessed)
    Extractor comment
    5. Structural validity: Were there any other important flaws in the design or statistical methods of the study?
    Describe other flaws
    Dependency
  • Question Position: 1
    • - Option: Structural validity
    Adequacy
    Single Choice
    Very good (No other flaws)
    Doubtful (Other minor flaws)
    Inadequate (Other important flaws)
    N/A (Structural validity not assessed)
    Extractor comment
    6. Internal consistency: Was an internal consistency statistic calculated for each unidimensional scale or subscale separately?
    Dependency
  • Question Position: 1
    • - Option: Internal consistency
    Adequacy
    Single Choice
    Very good (yes)
    Doubtful (unclear if unidimensional)
    Inadequate (no, not calculated on a unidimensional scale)
    N/A (Internal consistency not assessed)
    Extractor comment
    7. Internal consistency/continuous scores: Was Cronbach’s alpha or omega calculated?
    Dependency
  • Question Position: 1
    • - Option: Internal consistency
    Adequacy
    Single Choice
    Very good (yes)
    Doubtful (only item-total correlations calculated)
    Inadequate (no)
    N/A (Internal consistency/continuous scores not assessed)
    Extractor comment
    8. Internal consistency/dichotomous scores: Was Cronbach’s alpha or KR‐20 calculated?
    Dependency
  • Question Position: 1
    • - Option: Internal consistency
    Adequacy
    Single Choice
    Very good (yes)
    Doubtful (Only item-total correlations calculated)
    Inadequate (no)
    N/A (Internal consistency/dichotomous scores not assessed)
    Extractor comment
    9. Internal consistency/IRT‐based scores: Was standard error of the theta (SE (θ)) OR reliability coefficient of estimated latent trait value (index of (subject or item) separation) calculated?
    Dependency
  • Question Position: 1
    • - Option: Internal consistency
    Adequacy
    Single Choice
    Very good (yes)
    Inadequate (no)
    N/A (Internal consistency/IRT-based scores not assessed)
    Extractor comment
    10. Cross‐cultural validity/measurement invariance: Were the samples similar for relevant characteristics except for the group variable?
    Dependency
  • Question Position: 1
    • - Option: Cross-cultural validity/measurement invariance
    Adequacy
    Single Choice
    Very good (yes, evidence of similarity provided)
    Adequate (stated yes, but no evidence provided)
    Doubtful (unclear)
    Inadequate (no, not similar)
    N/A (Cross‐cultural validity/measurement invariance not assessed)
    Extractor comment
    11. Cross‐cultural validity\Measurement invariance: Was an appropriate approach used to analyze the data?
    Dependency
  • Question Position: 1
    • - Option: Cross-cultural validity/measurement invariance
    Adequacy
    Single Choice
    Very good (a widely recognized or well justified approach was used)
    Adequate (assumable yes, but not clearly described)
    Doubtful (unclear or doubtful that was appropriate)
    Inadequate (approach not appropriate)
    N/A (Cross‐cultural validity/measurement invariance not assessed)
    Extractor comment
    12. Cross‐cultural validity\Measurement invariance: Was the sample size included in the analysis adequate?
    *VERY GOOD*: Regression analyses or IRT/Rasch based analyses: N 200/group MGCFA: N 7 times the number of items, and N≥100 *ADEQUATE* Regression analyses or IRT/Rasch based analyses: N 150/group MGCFA: N 5 times the number of items, and N≥100 OR 5‐7 times the number of items, but N<100 *DOUBTFUL* Regression analyses or IRT/Rasch based analyses: N 100/group MGCFA: N 5 times the number of items, but N<100 *INADEQUATE* Regression analyses or IRT/Rasch based analyses: N<100/group MGCFA: N <5 times the number of items
    Dependency
  • Question Position: 1
    • - Option: Cross-cultural validity/measurement invariance
    Adequacy
    Single Choice
    Very good
    Adequate
    Doubtful
    Inadequate
    N/A (Cross‐cultural validity/measurement invariance not assessed)
    Extractor comment
    13. Reliability: Were patients stable in the interim period on the construct to be measured?
    Dependency
  • Question Position: 1
    • - Option: Reliability
    Adequacy
    Single Choice
    Very good (Evidence provided that patients were stable)
    Adequate (Assumable that patients were stable)
    Doubtful (Unclear if patients were stable)
    Inadequate (Patients were not stable)
    N/A (Reliability not assessed)
    Extractor comment
    14. Reliability: Was the time interval appropriate?
    Dependency
  • Question Position: 1
    • - Option: Reliability
    Adequacy
    Single Choice
    Very good (yes)
    Doubtful (doubtful or not stated)
    Inadequate (no)
    N/A (Reliability not assessed)
    Extractor comment
    15. Reliability: Were the test conditions similar for the measurements?
    E.g. type of administration, environment, instructions
    Dependency
  • Question Position: 1
    • - Option: Reliability
    Adequacy
    Single Choice
    Very good (Test conditions were similar, evidence provided)
    Adequate (Assumable that test conditions were similar)
    Doubtful (unclear)
    Inadequate (not similar)
    N/A (Reliability not assessed)
    Extractor comment
    16. Reliability/continuous scores: Was an intraclass correlation coefficient (ICC) calculated?
    *VERY GOOD* ICC calculated and model or formula of the ICC is described *ADEQUATE* ICC calculated but model or formula of the ICC not described or not optimalOR Pearson or Spearman correlation coefficient calculated with evidence provided that no systematic change has occurred *DOUBTFUL* Pearson or Spearman correlation coefficient calculated WITHOUT evidence provided that no systematic change has occurred or WITH evidence that systematic change has occurred *INADEQUATE* No ICC or Pearson or Spearman correlations calculated
    Dependency
  • Question Position: 1
    • - Option: Reliability
    Adequacy
    Single Choice
    Very good
    Adequate
    Doubtful
    Inadequate
    N/A (Reliability/continuous scores not assessed)
    Extractor comment
    17. Reliability/Dichotomous, nominal, ordinal scores: Was kappa calculated?
    Dependency
  • Question Position: 1
    • - Option: Reliability
    Adequacy
    Single Choice
    Very good (yes)
    Inadequate (no)
    N/A (Reliability/Dichotomous, nominal, ordinal scores not assessed)
    Extractor comment
    18. Reliability/ordinal scores: Was a weighted kappa calculated?
    Dependency
  • Question Position: 1
    • - Option: Reliability
    Adequacy
    Single Choice
    Very good (yes)
    Doubtful (unweighted kappa or not described)
    N/A (Reliability/ordinal scores not assessed)
    Extractor comment
    19. Reliability/ordinal scores: Was the weighting scheme described?
    E.g. linear, quadratic
    Dependency
  • Question Position: 1
    • - Option: Reliability
    Adequacy
    Single Choice
    Very good (yes)
    Adequate (no)
    N/A (Reliability/ordinal scores not assessed)
    Extractor comment
    20. Reliability: Were there any other important flaws in the design or statistical methods of the study?
    Describe other flaws
    Dependency
  • Question Position: 1
    • - Option: Reliability
    Adequacy
    Single Choice
    Very good (No other flaws)
    Doubtful (Other minor flaws)
    Inadequate (Other important flaws)
    N/A (Reliability not assessed)
    Extractor comment
    21. Measurement error: Were patients stable in the interim period on the construct to be measured?
    Dependency
  • Question Position: 1
    • - Option: Measurement error
    Adequacy
    Single Choice
    Very good (yes, evidence provided)
    Adequate (assumable that stable)
    Doubtful (unclear if stable)
    Inadequate (no, not stable)
    N/A (Measurement error not assessed)
    Extractor comment
    22. Measurement error: Was the time interval appropriate?
    Dependency
  • Question Position: 1
    • - Option: Measurement error
    Adequacy
    Single Choice
    Very good (yes)
    Doubtful (doubtful or time interval not stated)
    Inadequate (no, not appropriate)
    N/A (Measurement error not assessed)
    Extractor comment
    23. Measurement error: Were the test conditions similar for the measurements?
    E.g., type of administration, environment, instructions
    Dependency
  • Question Position: 1
    • - Option: Measurement error
    Adequacy
    Single Choice
    Very good (yes, evidence of similarity provided)
    Adequate (assumable were similar)
    Doubtful (unclear)
    Inadequate (no, not similar)
    N/A (Measurement error not assessed)
    Extractor comment
    24. Measurement error/continuous scores: Were the Standard Error of Measurement (SEM), Smallest Detectable Change (SDC) or Limits of Agreement (LoA) calculated?
    Dependency
  • Question Position: 1
    • - Option: Measurement error
    Adequacy
    Single Choice
    Very good (yes)
    Adequate (Possible to calculate LoA from the data presented)
    Inadequate (SEM calculated based on Cronbach’s alpha, or on SD from another population)
    N/A (Measurement error/continuous scores not assessed)
    Extractor comment
    25. Measurement error/Dichotomous, nominal, ordinal scores: Was the percentage (positive and negative) agreement calculated?
    Dependency
  • Question Position: 1
    • - Option: Measurement error
    Adequacy
    Single Choice
    Very good (yes, both)
    Adequate (% agreement calculated)
    Inadequate (not calculated)
    N/A (Measurement error/Dichotomous, nominal, ordinal scores not assessed)
    Extractor comment
    26. Criterion validity/continuous scores: Were correlations, or the area under the receiver operating curve calculated?
    Dependency
  • Question Position: 1
    • - Option: Criterion validity
    Adequacy
    Single Choice
    Very good (yes)
    Inadequate (no)
    N/A (Criterion validity/continuous scores not assessed)
    Extractor comment
    27. Criterion validity/dichotomous scores: Were sensitivity and specificity determined?
    Dependency
  • Question Position: 1
    • - Option: Criterion validity
    Adequacy
    Single Choice
    Very good (yes)
    Inadequate (no)
    N/A (Criterion validity/dichotomous scores not assessed)
    Extractor comment
    28. Criterion validity: Were there any other important flaws in the design or statistical methods of the study?
    Describe other flaws
    Dependency
  • Question Position: 1
    • - Option: Criterion validity
    Adequacy
    Single Choice
    Very good (No other flaws)
    Doubtful (Other minor flaws)
    Inadequate (Other important flaws)
    N/A (Criterion validity not assessed)
    Extractor comment
    29. Construct validity/Convergent: Is it clear what the comparator instrument(s) measure(s)?
    Comparison with other outcome measurement instruments
    Dependency
  • Question Position: 1
    • - Option: Construct validity
    Adequacy
    Single Choice
    Very good (yes)
    Inadequate (no)
    N/A (Construct validity/Convergent not assessed)
    Extractor comment
    30. Construct validity/Convergent: Were the measurement properties of the comparator instrument(s) sufficient?
    Comparison with other outcome measurement instruments *VERY GOOD* Sufficient measurement properties of the comparator instrument(s) in a population similar to the study population *ADEQUATE* Sufficient measurement properties of the comparator instrument(s) but not sure if these apply to the study population *DOUBTFUL* Some information on measurement properties of the comparator instrument(s) in any study population *INADEQUATE* No information on the measurement properties of the comparator instrument(s), OR evidence of insufficient measurement properties of the comparator instrument(s)
    Dependency
  • Question Position: 1
    • - Option: Construct validity
    Adequacy
    Single Choice
    Very good
    Adequate
    Doubtful
    Inadequate
    N/A (Construct validity/Convergent not assessed)
    Extractor comment
    31. Construct validity/Convergent: Were design and statistical methods adequate for the hypotheses to be tested?
    Comparison with other outcome measurement instruments
    Dependency
  • Question Position: 1
    • - Option: Construct validity
    Adequacy
    Single Choice
    Very good (appropriate)
    Adequate (assumable appropriate)
    Doubtful (Not optimal)
    Inadequate (Not appropriate)
    N/A (Construct validity/Convergent not assessed)
    Extractor comment
    32. Construct validity/Discriminative or known-groups: Was an adequate description provided of important characteristics of the subgroups?
    Comparison between subgroups
    Dependency
  • Question Position: 1
    • - Option: Construct validity
    Adequacy
    Single Choice
    Very good (adequate for all important characteristics)
    Adequate (adequate for most important characteristics)
    Doubtful (Poor to no description)
    N/A (Construct validity/Discriminative or known-groups not assessed)
    Extractor comment
    33. Construct validity/Discriminative or known-groups: Were design and statistical methods adequate for the hypotheses to be tested?
    Comparison between subgroups
    Dependency
  • Question Position: 1
    • - Option: Construct validity
    Adequacy
    Single Choice
    Very good (yes)
    Adequate (assumable yes)
    Doubtful (not optimal)
    Inadequate (not appropriate)
    N/A (Construct validity/Discriminative or known-groups not assessed)
    Extractor comment
    34. Responsiveness/Criterion approach/Continuous: Were correlations between change scores, or the area under the Receiver Operator Curve (ROC) curve calculated?
    Comparison to a gold standard
    Dependency
  • Question Position: 1
    • - Option: Responsiveness
    Adequacy
    Single Choice
    Very good (yes)
    Inadequate (no)
    N/A (Responsiveness/Criterion approach/Continuous not assessed)
    Extractor comment
    35. Responsiveness/Criterion approach/Dichotomous: Were sensitivity and specificity (changed versus not changed) determined?
    Comparison to a gold standard
    Dependency
  • Question Position: 1
    • - Option: Responsiveness
    Adequacy
    Single Choice
    Very good (yes)
    Inadequate (no)
    N/A (Responsiveness/Criterion approach/Dichotomous not assessed)
    Extractor comment
    36. Responsiveness/Construct approach (other PROM): Is it clear what the comparator instrument(s) measure(s)?
    hypotheses testing; comparison with other outcome measurement instruments
    Dependency
  • Question Position: 1
    • - Option: Responsiveness
    Adequacy
    Single Choice
    Very good (yes)
    Inadequate (no)
    N/A (Responsiveness/Construct approach not assessed)
    Extractor comment
    37. Responsiveness/Construct approach (other PROM): Were the measurement properties of the comparator instrument(s) sufficient?
    Hypotheses testing; comparison with other outcome measurement instruments *VERY GOOD* Sufficient measurement properties of the comparator instrument(s) in a population similar to the study population *ADEQUATE* Sufficient measurement properties of the comparator instrument(s) but not sure if these apply to the study population *DOUBTFUL* Some information on measurement properties of the comparator instrument(s) in any study population *INADEQUATE* NO information on the measurement properties of the comparator instrument(s) OR evidence of insufficient quality of comparator instrument(s)
    Dependency
  • Question Position: 1
    • - Option: Responsiveness
    Adequacy
    Single Choice
    Very good
    Adequate
    Doubtful
    Inadequate
    N/A (Responsiveness/Construct approach not assessed)
    Extractor comment
    38. Responsiveness/Construct approach (other PROM): Were design and statistical methods adequate for the hypotheses to be tested?
    Hypotheses testing; comparison with other outcome measurement instruments
    Dependency
  • Question Position: 1
    • - Option: Responsiveness
    Adequacy
    Single Choice
    Very good (yes, appropriate)
    Adequate (assumable appropriate)
    Doubtful (not optimal)
    Inadequate (not appropriate)
    N/A (Responsiveness/Construct approach not assessed)
    Extractor comment
    39. Responsiveness/Construct approach (other PROM): Were there any other important flaws in the design or statistical methods of the study?
    Describe other flaws
    Dependency
  • Question Position: 1
    • - Option: Responsiveness
    Adequacy
    Single Choice
    Very good (No other flaws)
    Doubtful (Other minor flaws)
    Inadequate (Other important flaws)
    N/A (Responsiveness/Construct approach not assessed)
    Extractor comment
    40. Responsiveness/Construct (subgroups): Was an adequate description provided of important characteristics of the subgroups?'
    Comparison between subgroups
    Dependency
  • Question Position: 1
    • - Option: Responsiveness
    Adequacy
    Single Choice
    Very good (adequate for all important characteristics)
    Adequate (adequate for most important characteristics)
    Doubtful (Poor to no description)
    N/A (Responsiveness/Construct (subgroups) not assessed)
    Extractor comment
    41. Responsiveness/Construct (subgroups): Were design and statistical methods adequate for the hypotheses to be tested?'
    Comparison between subgroups
    Dependency
  • Question Position: 1
    • - Option: Responsiveness
    Adequacy
    Single Choice
    Very good (appropriate)
    Adequate (assumable appropriate)
    Doubtful (Not optimal)
    Inadequate (Not appropriate)
    N/A (Responsiveness/Construct (subgroups) not assessed)
    Extractor comment
    42. Responsiveness/Construct (before-after):Was an adequate description provided of the intervention given?
    Dependency
  • Question Position: 1
    • - Option: Responsiveness
    Adequacy
    Single Choice
    Very good (yes)
    Doubtful (poor description)
    Inadequate (no description)
    N/A (Responsiveness/Construct (before-after) not assessed)
    Extractor comment
    43. Responsiveness/Construct (before-after): Were design and statistical methods adequate for the hypotheses to be tested?'
    Before and after intervention
    Dependency
  • Question Position: 1
    • - Option: Responsiveness
    Adequacy
    Single Choice
    Very good (yes, appropriate)
    Adequate (assumable appropriate)
    Doubtful (not optimal)
    Inadequate (not appropriate)
    N/A (Responsiveness/Construct (before-after) not assessed)
    Extractor comment
    44. MCID: Was the method to define MCID appropriate?
    NOTE: THIS QUESTION IS NOT IN COSMIN
    Dependency
  • Question Position: 1
    • - Option: MCID
    Adequacy
    Single Choice
    Very good (yes, appropriate)
    Adequate (assumable appropriate)
    Doubtful (not optimal)
    Inadequate (not appropriate)
    N/A (Responsiveness/Construct (before-after) not assessed)
    Extractor comment