Data extraction form and quality assessment methods used

Olga P Nyssen; Stephanie JC Taylor; Geoff Wong; Elizabeth Steed; Liam Bourke; Joanne Lord; Carol A Ross; Sheila Hayman; Victoria Field; Ailish Higgins; Trisha Greenhalgh; Catherine Meads

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Nyssen OP, Taylor SJC, Wong G, et al. Does therapeutic writing help people with long-term conditions? Systematic review, realist synthesis and economic considerations. Southampton (UK): NIHR Journals Library; 2016 Apr. (Health Technology Assessment, No. 20.27.)

Does therapeutic writing help people with long-term conditions? Systematic review, realist synthesis and economic considerations.

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Appendix 4Data extraction form and quality assessment methods used

Systematic review data extraction forms

Baseline data

TABLE 90

Data extraction form template: study overview

# (reference number in the citation manager)
Publication details	Author(s)
	Year
	Title
	Journal
	Volume
	Issue
	Pages
	Format of publication
Study overview	Study name
	Study objectives
	Study overall conclusions
	DID TW WORK?
	Why does it work? Why not? Who do they think it works for?
	Country/region of the study
	Time span of the study
	Number of sites
	Funding	Description of funding (public/private, etc.)
	Funding	Funded? Yes/No
Study moderators and/or mediators	Moderator(s) effect? Including: effect moderators (patients’ characteristics) interacting with the intervention to change outcome – baseline variables that affect outcome but not interact with intervention
Study moderators and/or mediators	Mediator(s) effect? Including: change-in-process factors impacting outcome with or without interaction with intervention

TABLE 91

Data extraction form template: intervention and participant’s characteristics

Study intervention: exposure and comparator	Intervention type(s)
	Definition
	Site of the intervention(s)
	Intervention(s) exposure episode and duration
	Length of the intervention(s)
	Comparator type
	Comparator definition
	Time of assessment
	Concomitant therapies
	Intervention fidelity
	Intervention credibility or subjective essay evaluation or manipulation checks
Participant(s) type	Target population	LTC category
		LTC type and diagnostic criteria
		LTC category
		ITT (and PP) sample size
		ITT sample size by groups (treatment arms)
Participants selection criteria	Main inclusion criteria
	Main exclusion criteria
Participants baseline characteristics	Baseline characteristics	Age
		Gender
		Ethnicity
		Disease status and severity
		Comorbidities
	Other characteristics

: PP, per protocol.

TABLE 92

Data extraction form template: primary studies’ participation and types of outcomes evaluated

Recruitment method(s)
Study flow diagram	Study participation [based on Sohanpal et al., www.systematicreviewsjournal.com/content/1/1/66 (accessed June 2014)]	# participants ELIGIBLE to the study (and # of non-participants)
		# participants RECRUITED (# of study participants willing to take part)
		# study participants NON-ATTENDERS (recruited not willing to attend intervention)
		# study ATTENDERS (attending at least one session of the intervention)
		# study attenders DROPPING OUT (after one session or more)
		# programme COMPLETERS (# participants completing all sessions of the intervention)
		Study DROP-OUTs (# non-attenders or programme dropouts or programme completers that drop out also from the study)
Type(s) of outcome(s) reported (by responding Yes/No)	Outcomes assessed
	Physical health	Physiological
		Haematological/immunological/hormonal
		Disability/handicap
		Pain
	Non-physical health	Psychological
		Social health
		Mental status
		Behavioural
		Performance
	HRQoL
	Costs/resource use
	Safety
	Compliance
	Other

Results section

TABLE 93

Data extraction form template: outcomes reported

Physiological outcomes	Description	Selected end point(s)
		Definition(s) and type of outcome
		Time of assessment(s) and overall outcome follow-up
		Type of analysis
	Results	Values
		Summary of the impact of intervention(s) on patient-reported outcomes
Haematological/immunological outcomes	Description	Selected end point(s)
		Definition(s)
		Time of assessment(s) and overall outcome follow-up
		Type of analysis
	Results	Values
		Summary of the impact of intervention(s) on patient-reported outcomes
Physical disability/handicap assessment	Description	Selected end point(s)
		Definition(s)
		Time of assessment(s) and overall outcome follow-up
		Type of analysis
	Results	Values
		Summary of the impact of the intervention
Pain measurement	Description	Selected end point(s)
		Definition(s)
		Time of assessment(s) and overall outcome follow-up
		Type of analysis
	Results	Values
		Summary of the impact of intervention(s) on patient-reported outcomes
Psychological assessment	Description	Selected end point(s)
		Definition(s)
		Time of assessment(s) and overall outcome follow-up
		Type of analysis
	Results	Values
		Summary of the impact of intervention(s) on patient-reported outcomes
Social health assessment	Description	Selected end point(s)
		Definition(s)
		Time of assessment(s) and overall outcome follow-up
		Type of analysis
	Results	Values
		Summary of the impact of intervention(s) on patient-reported outcomes
Mental status assessment	Description	Selected end point(s)
		Definition(s)
		Time of assessment(s) and overall outcome follow-up
		Type of analysis
	Results	Values
		Summary of the impact of intervention(s) on patient-reported outcomes
Behavioural assessment	Description	Selected end point(s)
		Definition(s)
		Time of assessment(s) and overall outcome follow-up
		Type of analysis
	Results	Values
		Summary of the impact of intervention(s) on patient-reported outcomes
Performance assessment	Description	Selected end point(s)
		Definition(s)
		Time of assessment(s) and overall outcome follow-up
		Type of analysis
	Results	Values
		Summary of the impact of intervention(s) on patient-reported outcomes
General health status and quality of life	Description	Instrument(s) type
		Definition
		Time of assessment(s) and overall outcome follow-up
		Type of analysis
	Results	Values
		Summary of the impact of intervention(s) on patient-reported outcomes
Assessment of adverse events due to intervention (and not related to concomitant therapy)	Description and identification of AEs	Selected end point(s)
		Definition(s)/reported categories of AEs
		Time of assessment(s)
		Type of analysis
	Results
Assessment of compliance (adherence)	Description	Selected end point(s)
		Definition(s)
		Time of assessment
	Results
Costs and levels of resource use (related to specific intervention)	Resource use	Type
		Analysis
		Levels of resource used
		Summary of the impact of intervention(s) on resource used
	Perspective
	Currency	Currency
		Price year
		If inflated, inflator
	Time period to which costs relate
	Unit cost
	Total costs
Specific findings helping programme theory	Theories or mechanisms postulated by study’s authors to explain the success of the intervention
	Process factors identified by study authors helping the successful theory
	Theories or mechanisms postulated by study’s authors to explain the failure(s) of the intervention
	Process factors identified by study authors helping the failure of the theory
	How study contributes to realist review
Summary of the impact of intervention(s) on patient-reported outcomes
Additional comments to the study (does the study support previous research?)
Correspondence required with authors for missing data?
References not captured by the review (cross-referencing)
Notes

: AE, adverse event.

Realist synthesis data extraction forms

TABLE 94

Tabular summary for data collection in realist synthesis

First author, date

Data to support programme theory included in the systematic review

Primary study author’s explanation for how TW works

TABLE 95

Questions formulated for practitioner experts during programme theory development

Recruitment/suitability	Intervention process/aspects of the intervention	Outcomes impact
Who is it suitable for and why?	What do you do and why?	What do you hope to achieve and why?

Quality assessment tools

Clinical trials: Cochrane Handbook for Systematic Reviews of Interventions

TABLE 96

Data extraction form template: quality of the methods used in clinical trials

Study design	Trial design
Study quality checklist (based on the checklist in the Cochrane Handbook)	Randomisation	Sequence generation (selection bias)
	Randomisation	Allocation concealment (selection bias)
	Blinding	Outcome
	Blinding	Performance
	ITT analysis? (Yes/No)
	Description of outcomes differences between groups (selective reporting)
	Description of withdrawals (attrition bias)
	Pre-specified criteria for eligibility of patients
	Similarity of groups at baseline regarding prognostic factors
	Statement supporting the quality of the methods used

Observational studies: Newcastle–Ottawa checklist

TABLE 97

Data extraction form template: quality of the methods used in observational studies

Study quality checklist	Case–control studies	Selection	Is the case definition adequate?
			Representativeness of the cases
			Selection of controls
			Definition of controls
		Comparability	Comparability of cases and controls on the basis of the design or analysis
			Factor(s)
		Exposure	Ascertainment of exposure
			Same method of ascertainment for cases and controls
			Non-response rate
	Cohort (and cross-sectional) studies	Selection	Representativeness of the exposed cohort
			Selection of the non-exposed cohort
			Ascertainment of exposure
			Demonstration that outcome of interest was not present at start of study
		Comparability	Comparability of exposed and unexposed (design or analysis)
			Factor(s)
		Outcome	Assessment of outcome
			Was follow-up long enough for outcome to occur
			Adequacy of follow-up

Copyright © Queen’s Printer and Controller of HMSO 2016. This work was produced by Nyssen et al. under the terms of a commissioning contract issued by the Secretary of State for Health. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

Included under terms of UK Non-commercial Government License.

Bookshelf ID: NBK355732

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Nyssen OP, Taylor SJC, Wong G, et al. Does therapeutic writing help people with long-term conditions? Systematic review, realist synthesis and economic considerations. Southampton (UK): NIHR Journals Library; 2016 Apr. (Health Technology Assessment, No. 20.27.) Appendix 4, Data extraction form and quality assessment methods used.
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