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Buscemi N, Vandermeer B, Friesen C, et al. Manifestations and Management of Chronic Insomnia in Adults. Rockville (MD): Agency for Healthcare Research and Quality (US); 2005 Jun. (Evidence Reports/Technology Assessments, No. 125.)

  • This publication is provided for historical reference only and the information may be out of date.

This publication is provided for historical reference only and the information may be out of date.

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Manifestations and Management of Chronic Insomnia in Adults.

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Appendix B: Data Extraction and Quality Assessment Forms

Form B-1: Data extraction form for studies on manifestations of chronic insomnia in adults

Form B-2: Data extraction form for studies on management of chronic insomnia in adults

Form B-3: Quality assessment form for studies on prevalence or incidence of chronic insomnia in adults

Form B-4: Quality assessment form for cohort studies on manifestations of chronic insomnia in adults

Form B-5: Quality assessment form for case-control studies on manifestations of chronic Insomnia in adults

Form B-6: Quality assessment form for studies on management of chronic insomnia in adults

Form B-1: Data extraction form for studies on manifestations of chronic insomnia in adults

To be extracted from all studies, except where indicated.
Record ID Indicate if Relevant to Prevalence Indicate if Relevant to Natural History Indicate if Relevant to Incidence Indicate if Relevant to Associated Factors Reviewer/Date First Author
Year of Publication Study Site Study Setting (if relevant to prevalence) Objective(s) Study Design Sampling Frame and Method of Sampling (if relevant to prevalence) Time Frame for the Study
Intended Sample Size Response/Follow-up Rate Method of Data Collection (if relevant to prevalence) Type of Participants Definition of Cases and Comparison Groups, if applicable Gender Distribution of Population Age Distribution of Population
Ethnicity of Population Co-morbid Conditions of Population at Entry Prevalence of Chronic Insomnia (if relevant to prevalence) Incidence of Chronic Insomnia (if relevant to incidence) Natural History of Chronic Insomnia (if relevant to natural history) Associated Factors of Chronic Insomnia (if relevant to associated factors) Qualitative Summary of Findings (if relevant to associated factors)

Form B-2: Data extraction form for studies on management of chronic insomnia in adults

Study ID: Reviewer Initials: Verifier Initials:
First Author:
Title:
Year of Publication: Language of Publication: Country of Corresponding Author:
Funding:
Private Industry __Not Specified __
Government __
Foundation __
Internal __
Other __
Role of Funding Organization:
Study Design: Parallel __Crossover __Unclear __
Intent to Treat Analysis: Yes ___No ___Unclear ___N/A ___
Quality Score:
Number of Participants Enrolled:
Number of Males Enrolled: Number of Females Enrolled:
Age of Participants:
Withdrawals/Dropouts: Yes ___No ___Unclear ___
If yes, state number of withdrawals/ group and reasons for withdrawal: Overall:
Treatment Group(s):
Control Group:
Criteria for Insomnia:
Length of Insomnia:
Primary Chronic Insomnia: Yes ___No ___
If primary chronic insomnia, list any co-morbid conditions:
Secondary Chronic Insomnia: Yes ___No ___
If secondary chronic insomnia, secondary to what condition (if psychiatric, see below)?
Psychiatric Illness: Yes ___No ___
If Yes, specify:
Method used to Assess Outcomes:
PSG: ___
Actigraphy: ___
Diary: ___
If different methods were used for different outcomes OR more than one method was used for one or more outcomes, please specify:
Treatment GroupInterventionFrequency and Duration of TreatmentTimingRoute of DeliveryNumber of Participants Allocated/ AnalyzedLength of Follow-up
1
2
3
4
Did participants have a treatment preference? If so, indicate which treatment was preferred and related information.
Treatment Group 1Treatment Group 2Treatment Group 3Treatment Group 4
Interventions
Sleep Onset Latency (SOL)
Definition of SOL:
Wakefulness after Sleep Onset (WASO)
Definition of WASO:
Sleep Efficiency (SE)
Definition of SE:
Total Sleep Time(TST)
Definition of TST:
Sleep Quality (SQ)
Definition of SQ:
Quality of Life (QOL)
Definition of QOL:
Adverse Effects/Events

Form B-3: Quality assessment form for studies on prevalence or incidence of chronic insomnia in adults

The criteria used to rate studies relevant to the prevalence or incidence of chronic insomnia in adults is outlined below (Loney PL, 1998). One point was assigned for each criterion that was satisfied. The maximum score was eight.

  1. Random sample or whole population
  2. Unbiased sampling frame (i.e. census data)
  3. Adequate sample size
  4. Measures were the standard
  5. Outcomes measured by unbiased assessors
  6. Adequate response rate (70 percent), refusers described
  7. Confidence intervals, subgroup analysis
  8. Study subjects described

>Form B-4: Quality assessment form for cohort studies on manifestations of chronic insomnia in adults (Newcastle-Ottawa scale)

Note: A study could be awarded a maximum of one star for each numbered item within the Selection and Outcome categories. A maximum of two stars could be awarded for Comparability. Each star was equivalent to one point. The maximum score was nine.

Selection

  1. Representativeness of the exposed cohort
    1. truly representative of the average _______________ (describe) in the community *
    2. somewhat representative of the average ______________ in the community *
    3. selected group of users e.g. nurses, volunteers
    4. no description of the derivation of the cohort
  2. Selection of the non exposed cohort
    1. drawn from the same community as the exposed cohort *
    2. drawn from a different source
    3. no description of the derivation of the non exposed cohort
  3. Ascertainment of exposure
    1. secure record (e.g. surgical records) *
    2. structured interview *
    3. written self report
    4. no description
  4. Demonstration that outcome of interest was not present at start of study
    1. yes *
    2. no

Comparability

  1. Comparability of cohorts on the basis of the design or analysis
    1. study controls for _____________ (select the most important factor) *
    2. study controls for any additional factor * (This criteria could be modified to indicate specific control for a second important factor.)

Outcome

  1. Assessment of outcome
    1. independent blind assessment *
    2. record linkage *
    3. self report
    4. no description
  2. Was follow-up long enough for outcomes to occur
    1. yes (select an adequate follow up period for outcome of interest) *
    2. no
  3. Adequacy of follow up of cohorts
    1. complete follow up - all subjects accounted for *
    2. subjects lost to follow up unlikely to introduce bias - small number lost - > ____ % (select an adequate percent) follow up, or description provided of those lost) *
    3. follow up rate < ____% (select an adequate percent) and no description of those lost
    4. no statement

Form B-5: Quality assessment form for case-control studies on manifestations of chronic insomnia in adults (Newcastle-Ottawa scale)

Note: A study could be awarded a maximum of one star for each numbered item within the Selection and Exposure categories. A maximum of two stars could be awarded for Comparability. Each star was equivalent to one point. The maximum score was nine.

Selection

  1. Is the case definition adequate?
    1. yes, with independent validation *
    2. yes, e.g. record linkage or based on self reports
    3. no description
  2. Representativeness of the cases
    1. consecutive or obviously representative series of cases *
    2. potential for selection biases or not stated
  3. Selection of Controls
    1. community controls *
    2. hospital controls
    3. no description
  4. Definition of Controls
    1. no history of disease (endpoint) *
    2. no description of source

Comparability

  1. Comparability of cases and controls on the basis of the design or analysis
    1. study controls for _______________ (Select the most important factor.) *
    2. study controls for any additional factor * (This criteria could be modified to indicate specific control for a second important factor.)

Exposure

  1. Ascertainment of exposure
    1. secure record (e.g. surgical records) *
    2. structured interview where blind to case/control status *
    3. interview not blinded to case/control status
    4. written self report or medical record only
    5. no description
  2. Same method of ascertainment for cases and controls
    1. yes *
    2. no
  3. Non-Response rate
    1. same rate for both groups *
    2. non respondents described
    3. rate different and no designation

Form B-6: Quality assessment form for studies on management of chronic insomnia in adults (Jadad scale and allocation concealment for quality assessment of RCTs)

Study # _______________Initials of Assessor: _____
Part 1 (from Jadad - Controlled Clin Trials 1996; 17:1–12)Score
1. Was the study described as randomized (this includes the use of words such as randomly, random and randomization)?
Yes = 1No = 0______
2. Was the study described as double-blind?
Yes = 1No = 0______
3. Was there a description of withdrawals and drop-outs?
Yes = 1No = 0______
Additional points: Add 1 point if:
Method to generate the sequence of randomization was described and was appropriate (e.g. table of random numbers, computer generated, coin tossing, etc.)______
Method of double-blinding described and appropriate (identical placebo, active placebo, dummy)______
Point deduction: Subtract 1 point if:
Method of randomization described and it was inappropriate (allocated alternately, according to date of birth, hospital number, etc.)______
Method of double-blinding described but it was inappropriate (comparison of tablet vs. injection with no double dummy)_____
OVERALL SCORE (Maximum 5) _____
Part 2 (from Schulz - JAMA 1995; 273:408–12)
Concealment of treatment allocation:□ Adequate
□ Inadequate
□ Unclear
Adequate:e.g. central randomization; numbered/coded containers; drugs prepared by pharmacy; serially numbered, opaque, sealed envelopes
Inadequate:e.g. alternation, use of case record numbers, dates of birth or day of week; open lists
Unclear:Allocation concealment approach not reported or fits neither above category

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