title: Tool for evaluating research implementation challenges: a sense-making protocol for addressing implementation challenges in complex research settings.
abstract: BACKGROUND
  Many challenges arise in complex organizational interventions that threaten research integrity. This article describes a Tool for Evaluating Research Implementation Challenges (TECH), developed using a complexity science framework to assist research teams in assessing and managing these challenges.
  
  
  METHODS
  During the implementation of a multi-site, randomized controlled trial (RCT) of organizational interventions to reduce resident falls in eight nursing homes, we inductively developed, and later codified the TECH. The TECH was developed through processes that emerged from interactions among research team members and nursing home staff participants, including a purposive use of complexity science principles.
  
  
  RESULTS
  The TECH provided a structure to assess challenges systematically, consider their potential impact on intervention feasibility and fidelity, and determine actions to take. We codified the process into an algorithm that can be adopted or adapted for other research projects. We present selected examples of the use of the TECH that are relevant to many complex interventions.
  
  
  CONCLUSIONS
  Complexity theory provides a useful lens through which research procedures can be developed to address implementation challenges that emerge from complex organizations and research designs. Sense-making is a group process in which diverse members interpret challenges when available information is ambiguous; the groups' interpretations provide cues for taking action. Sense-making facilitates the creation of safe environments for generating innovative solutions that balance research integrity and practical issues. The challenges encountered during implementation of complex interventions are often unpredictable; however, adoption of a systematic process will allow investigators to address them in a consistent yet flexible manner, protecting fidelity. Research integrity is also protected by allowing for appropriate adaptations to intervention protocols that preserve the feasibility of 'real world' interventions.
authors.affiliation: Durham Veteran Affairs Medical Center, GRECC, 508 Fulton St., Durham, NC 27705, USA.
authors.forename: Kelly M
authors.initials: KM
authors.lastname: Simpson
authors.forename: Kristie
authors.initials: K
authors.lastname: Porter
authors.forename: Eleanor S
authors.initials: ES
authors.lastname: McConnell
authors.forename: Cathleen
authors.initials: C
authors.lastname: Colón-Emeric
authors.forename: Kathryn A
authors.initials: KA
authors.lastname: Daily
authors.forename: Alyson
authors.initials: A
authors.lastname: Stalzer
authors.forename: Ruth A
authors.initials: RA
authors.lastname: Anderson
mesh_terms: D000058:Accidental Falls / Q000517:prevention & control*; D000465:Algorithms; D002985:Clinical Protocols / Q000592:standards; D057186:Comparative Effectiveness Research; D003657:Decision Making; D004059:Diffusion of Innovation; D005069:Evaluation Studies as Topic; D019317:Evidence-Based Medicine; D006126:Group Processes; D006801:Humans; D007318:Inservice Training / Q000379:methods; D009735:Nursing Homes / Q000458:organization & administration; D009740:Nursing Staff / Q000193:education; D009936:Organizational Innovation; D010865:Pilot Projects; D058996:Quality Improvement / Q000458:organization & administration / Q000592:standards; D012107:Research Design