J.1(c)_QIN-QIO_Squire_Guidelines_for_Reporting_Intervention_Trials.docx

Attachment J.1(c) - QIN-QIO Squire Guidelines for Reporting Interventions Trials

HHSM-500-2014-RFP-QIN-QIO

SQUIRE Guidelines (Standards for Quality Improvement Reporting Excellence)

1. These guidelines are intended to provide a framework for writing and publishing reports of studies that formally assess the nature and effectiveness of interventions carried out to improve the quality and safety of care. (Guidelines for informal reports of experiences with QI interventions can be found at: [URL for QSHC/BMJ QI reporting guidelines])

1. Although each major section (i.e., Introduction, Methods, Results, and Discussion) of published reports of original studies generally contains at least some information about all the numbered items included in the corresponding guideline section, some information about individual items from one section (for example, the Introduction) is often also needed in other sections (for example, the Discussion).

Front matter

What did you do to help with finding, indexing, and scanning your report?

Introduction

Why did you undertake the intervention, and why did you decide to study it?

3. Background Knowledge

1. Provides a brief, balanced summary of current knowledge of care problem being addressed, and characteristics of organizations in which it occurs

1. Specifies who (champions, supporters) and what (events, observations) triggered the decision to make changes, and why now (timing)

1. Indicates the factors contributing to choice of the specific improvement intervention (e.g., analysis of causes of the dysfunction; prior studies of relevant improvement strategies)

5. Intended improvement

1. Describes the specific aim (changes/improvements in care processes and patient outcomes) of the proposed intervention

9. Planning the intervention

1. Characterizes in detail how the intervention was initially planned: i.e., what was to be done (initial steps; functions to be accomplished by those steps; how tests of change would be used to modify the intervention), and by whom (intended roles, qualifications, and training of staff)

10. Planning the study

1. Outlines plans made for assessing how well the intervention was implemented (dose or intensity of exposure)

1. Describes the mechanisms (theories) by which intervention components were expected to cause changes, and approaches planned for testing whether those mechanisms were effective

1. Identifies the experimental or quasi-experimental design chosen for measuring impact of the intervention on primary and secondary outcomes, if applicable

1. Explains efforts planned for implementing the essential aspects of chosen study design, as described in appropriate study design publication guidelines (see, for example, www.equator-network.org)

1. Describes specific plans made for maximizing internal and external validity

11. Methods of evaluation

1. Describes instruments (qualitative, quantitative, or mixed) used to assess a) effectiveness of implementation, b) contributions of intervention components and context factors to effectiveness of the intervention, and c) primary and secondary outcomes

1. Reports efforts to validate and test reliability of assessment instruments

1. Explains methods used to assure data quality (e.g., blinding, repeating measurements and data extraction; training in data collection)

1. Aligns unit of analysis with level at which the intervention was applied (if applicable)

1. Specifies degree of variability expected in implementation, change expected in primary outcome (effect size), and ability of study design (including size) to detect such effects

1. Describes analytic methods used to demonstrate effects of time as a variable (e.g., statistical process control)

1. Characterizes relevant elements of setting or settings (e.g., geography, physical resources, organizational culture, history of change efforts), and structures and patterns of care (e.g., staffing, leadership) that provided context for the intervention

1. Explains the actual course of the intervention (e.g., sequence of steps, events or phases; type and number of participants at key points), preferably using a time-line diagram or flow chart

1. Documents degree of success in implementing intervention components

1. Describes how and why the initial plan evolved, and the most important lessons learned from that evolution, particularly the effects of internal feedback from tests of change (reflexiveness)

b) Changes in processes of care and patient outcomes associated with the intervention

1. Presents data on changes observed in the care delivery process

1. Presents data on changes observed in measures of patient outcome (e.g., morbidity, mortality, function, patient/staff satisfaction, service utilization, cost, care disparities)

1. Presents evidence on strength of the association between observed changes in outcomes and intervention components and context factors

1. Includes summary of missing data for intervention and outcomes

15. Relation to other evidence

1. Compares and contrasts study results with relevant findings of others, drawing on broad and balanced review of the literature; use of a summary table may be helpful in building on existing evidence

1. Explores factors affecting generalizability (external validity), particularly features of local settings and implementation of the intervention

1. Addresses likelihood that observed gains may weaken over time, and describes plans, if any, for monitoring and maintaining improvement; explicitly states if such planning was not done

1. Reviews efforts made to minimize and adjust for study limitations

1. Assesses the effect of study limitations on interpretation and application of results

1. Draws inferences consistent with the strength of the data about causal mechanisms and size of observed changes, paying particular attention to components of the intervention and context factors that helped determine the intervention’s effectiveness (or lack thereof)

1. Suggests steps that might be modified to improve future performance

1. Reviews issues of opportunity cost and actual financial cost of the intervention

1. Suggests implications of this report for further studies of improvement interventions