Quality: broadly defined to include the safety, effectiveness, patientcenteredness,timeliness, efficiency, and equity of care
Study method: the specific, structured approach for collecting and analyzing data, for example: "A qualitative study," or "A randomized cluster trial"

Care problem: the characteristics of both the failure or dysfunction itself, and the organizations or settings in which it occurs

The dimensions or scale of the problem/opportunity,or the ways the problem was locally recognizable

Specific aim: the changes/improvements in both processes of care and patient (clinical) outcomes expected from the planned intervention
Who: the champions, leaders, supporters, and owners of the intervention process
What: the events and observations that triggered the decision to intervene
Why now: the factors that determined the timing of the decision to intervene

Primary question: the central focus of the evaluation, usually did the intervention work, and if so, for whom, by what mechanism, and under what circumstances?
Secondary question: related and interesting but more peripheral foci of the Evaluation

Ethical aspects: these generally include privacy concerns and protection of participants' physical well-being; potential author conflicts of interest; the question whether a specific project is improvement or research; and the question of need for independent, prior ethics review

Local care environment: local factors:  for example, physical resources, staffing, organizational mission, structure and culture, finances, leadership, history of change - that influence both the way improvements are implemented and their degree of effectiveness; these are the main determinants of generalizability (external validity)

Choice of the intervention: contributing factors could include analysis of specific nature and causes of the dysfunction; suitability of the intervention for the specific setting; strength of published evidence for effectiveness; feasibility; "trialability;" visibility
What was to be done: specific initial steps that were planned for putting the changes into place; what those steps were designed to accomplish; how results from tests of change would be used to modify intervention
By whom: intended roles, qualifications, and training of staff involved in implementing the improvement

How well: the dose or intensity of exposure to the intervention
Mechanisms: drivers of performance change, for example, reminders (clinical guidelines, order sets); incentives (financial, public recognition); social conformity (public disclosure of performance); power (control of information, resources); convenience (simplification), and the like
Testing mechanisms: approaches for gathering evidence on why an intervention worked - for example, case studies and narrative techniques to determine the populations and settings in which the intervention does or doesn't work); studying the effects of leaving out a specific intervention component; dose effects
Study design: the structure of the specific method(s) chosen for gathering evidence on whether an intervention was effective
Essential aspects of study design: some elements of study design are more critical than others; guidance on the essential aspects of various designs is available in publication guidelines (see http://www.equator-network.org)
Internal validity: the degree to which study results can be attributed to the variable of interest, by minimizing bias, confounding, or other sources of distortion in the data
External validity: the extent to which the study results provide a correct and proper basis for generalization to a larger target population

Instruments and procedures: includes qualitative, quantitative, or mixed methods for collecting data
Validation of instruments: determination of accuracy (reflection of true values), precision (repeatability)
Assuring data quality and adequacy: methods might include blinding of observers and participants; repeating measurements and data extraction; training in data collection; collection of sufficient baseline measurements

Analytic methods: Ways of detecting presence and size of effects, degree of uncertainty in assessment
Power: the ability of the study to detect changes in process and outcome that actually result from the intervention (sensitivity), largely a function of study size, and measurement precision
Time as a variable: techniques for recording, analyzing, and presenting these effects might include time series and statistical process control

Elements of the setting(s): description of the relevant local context factors actually found
Structures and patterns of care: initial organization (staffing, leadership), care processes and procedures
Actual course of the intervention: the sequence of steps, events, or phases involved in implementing the intervention, and the type and number of participants at key points; a time-line diagram, time-ordered table, or flow chart can be helpful in presenting this information
Important lessons: how and why the initial plan changed over time, particularly what was learned through internal feedback from tests of change (reflexiveness)

Processes of care: new sequences and patterns of care, organizational structures, staffing patterns, clinical tools resulting from the intervention; performance measures for these new processes might include reliability/dependablity, failure rate, timeliness, resource cost, re-work requirements
Patient outcomes: these might include morbidity, mortality, function, patient/staff satisfaction, service utilization, cost, care disparities

Findings of others: implies the need to draw on broad review of the literature; use of a summary table may be helpful in building on existing evidence

Confounding: misinterpretation of the effects of one factor by confusing it with the effects of another
Bias: psychological factors (for example, preconceptions, conflicts of interest) that impair impartial interpretations; technical factors (for example, improper sampling ) that skew quantitative results from their true value
Imprecision: mechanical and technical inaccuracies in definition, collection, or analysis of data