Understanding the complexity of surgical procedures in RCTs: a pilot study to test the application of the MRC framework for evaluating complex healthcare interventions in the operating theatre

Eveleigh, Mark; Blencowe, Natalie S; Mills, Nicola; Blazeby, Jane M

doi:10.1186/1745-6215-12-s1-a148

Cited by 3 publications

(1 citation statement)

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“…There has been much work in recent years on methods for evaluating complex interventions [ 9 , 10 , 31 , 59 , 60 ]. At the same time, there has been work on methods for assessing surgical innovations, on the basis of their inherently complex nature [ 61 , 62 ], with some arguing for the inclusion of qualitative data collection alongside RCTs of surgical procedures [ 63 ]. Process evaluations are recommended when evaluating complex interventions because, although the RCT design remains as the most reliable method of determining effectiveness [ 9 ], it is necessary to understand the mechanisms through which the intervention achieves its outcomes [ 59 ].…”

Section: Discussionmentioning

confidence: 99%

Integration of robotic surgery into routine practice and impacts on communication, collaboration, and decision making: a realist process evaluation protocol

et al. 2014

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BackgroundRobotic surgery offers many potential benefits for patients. While an increasing number of healthcare providers are purchasing surgical robots, there are reports that the technology is failing to be introduced into routine practice. Additionally, in robotic surgery, the surgeon is physically separated from the patient and the rest of the team, with the potential to negatively impact teamwork in the operating theatre. The aim of this study is to ascertain: how and under what circumstances robotic surgery is effectively introduced into routine practice; and how and under what circumstances robotic surgery impacts teamwork, communication and decision making, and subsequent patient outcomes.Methods and designWe will undertake a process evaluation alongside a randomised controlled trial comparing laparoscopic and robotic surgery for the curative treatment of rectal cancer. Realist evaluation provides an overall framework for the study. The study will be in three phases. In Phase I, grey literature will be reviewed to identify stakeholders’ theories concerning how robotic surgery becomes embedded into surgical practice and its impacts. These theories will be refined and added to through interviews conducted across English hospitals that are using robotic surgery for rectal cancer resection with staff at different levels of the organisation, along with a review of documentation associated with the introduction of robotic surgery. In Phase II, a multi-site case study will be conducted across four English hospitals to test and refine the candidate theories. Data will be collected using multiple methods: the structured observation tool OTAS (Observational Teamwork Assessment for Surgery); video recordings of operations; ethnographic observation; and interviews. In Phase III, interviews will be conducted at the four case sites with staff representing a range of surgical disciplines, to assess the extent to which the results of Phase II are generalisable and to refine the resulting theories to reflect the experience of a broader range of surgical disciplines. The study will provide (i) guidance to healthcare organisations on factors likely to facilitate successful implementation and integration of robotic surgery, and (ii) guidance on how to ensure effective communication and teamwork when undertaking robotic surgery.

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Section: Discussionmentioning

confidence: 99%

Integration of robotic surgery into routine practice and impacts on communication, collaboration, and decision making: a realist process evaluation protocol

et al. 2014

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From Bricks to Buildings

Haji

Silva

Daigle

et al. 2014

Simulation in Healthcare: The Journal of the Society for Simulation in Healthcare

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Presently, health care simulation research is largely conducted on a study-by-study basis. Although such "project-based" research generates a plethora of evidence, it can be chaotic and contradictory. A move toward sustained, thematic, theory-based programs of research is necessary to advance knowledge in the field. Recognizing that simulation is a complex intervention, we present a framework for developing research programs in simulation-based education adapted from the Medical Research Council (MRC) guidance. This framework calls for an iterative approach to developing, refining, evaluating, and implementing simulation interventions. The adapted framework guidance emphasizes: (1) identification of theory and existing evidence; (2) modeling and piloting interventions to clarify active ingredients and identify mechanisms linking the context, intervention, and outcomes; and (3) evaluation of intervention processes and outcomes in both the laboratory and real-world setting. The proposed framework will aid simulation researchers in developing more robust interventions that optimize simulation-based education and advance our understanding of simulation pedagogy.

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A cross-sectional retrospective analysis of the regionalization of complex surgery

Studnicki¹,

Craver

Blanchette³

et al. 2014

BMC Surg

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BackgroundThe Veterans Health Administration (VHA) system has assigned a surgical complexity level to each of its medical centers by specifying requirements to perform standard, intermediate or complex surgical procedures. No study to similarly describe the patterns of relative surgical complexity among a population of United States (U.S) civilian hospitals has been completed.MethodsDesign: single year, retrospective, cross-sectional.Setting/Participants: the study used Florida Inpatient Discharge Data from short-term acute hospitals for calendar year 2009. Two hundred hospitals with 2,542,920 discharges were organized into four quartiles (Q 1, 2, 3, 4) based on the number of complex procedures per hospital. The VHA surgical complexity matrix was applied to assign relative complexity to each procedure. The Clinical Classification Software (CCS) system assigned complex procedures to clinically meaningful groups. For outcome comparisons, propensity score matching methods adjusted for the surgical procedure, age, gender, race, comorbidities, mechanical ventilator use and type of admission.Main Outcome Measures: in-hospital mortality and length-of-stay (LOS).ResultsOnly 5.2% of all inpatient discharges involve a complex procedure. The highest volume complex procedure hospitals (Q4) have 49.8% of all discharges but 70.1% of all complex procedures. In the 133,436 discharges with a primary complex procedure, 374 separate specific procedures are identified, only about one third of which are performed in the lowest volume complex procedure (Q1) hospitals. Complex operations of the digestive, respiratory, integumentary and musculoskeletal systems are the least concentrated and proportionately more likely to occur in the lower volume hospitals. Operations of the cardiovascular system and certain technology dependent miscellaneous diagnostic and therapeutic procedures are the most concentrated in high volume hospitals. Organ transplants are only done in Q4 hospitals. There were no significant differences in in-hospital mortality rates and the longest lengths of stay were found in higher volume hospitals.ConclusionsComplex surgery in Florida is effectively regionalized so that small volume hospitals operating within the range of complex procedures appropriate to their capabilities provide no increased risk of post surgical mortality.

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Understanding the complexity of surgical procedures in RCTs: a pilot study to test the application of the MRC framework for evaluating complex healthcare interventions in the operating theatre

Cited by 3 publications

References 1 publication

Integration of robotic surgery into routine practice and impacts on communication, collaboration, and decision making: a realist process evaluation protocol

Integration of robotic surgery into routine practice and impacts on communication, collaboration, and decision making: a realist process evaluation protocol

From Bricks to Buildings

A cross-sectional retrospective analysis of the regionalization of complex surgery

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