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

Abstract BackgroundThe Bridging the Age Gap in Breast Cancer research programme sought to improve treatment decision-making for older women with breast cancer by developing and testing, in a cluster randomised trial, two decision support interventions (DESIs). One DESI supported the decision to have either primary endocrine therapy (PET) or surgery with adjuvant therapies and the second supported the decision to have adjuvant chemotherapy after surgery or not.MethodsSixteen sites were randomly selected to take part in the process evaluation. Multiple methods of data collection were used. Medical Research Council (MRC) guidelines for the evaluation of complex interventions were used.ResultsEighty-two patients, mean age 75.5, (range 70–93) provided data for the process evaluation. Seventy-three interviews were completed with patients. Ten clinicians from six intervention sites took part in telephone interviews. Dose: Ninety-one members of staff in the intervention arm received intervention training. Reach: The online tool was accessed on 324 occasions by 27 clinicians. Reasons for non-use of the online tool were commonly that the patient had already made a decision or that there was no online access in the clinic. Of the 32 women for whom there were data available, fifteen from the intervention arm and six from the usual care arm were offered a choice of treatment. Fidelity: Clinicians used the online tool in different ways, with some using it during the consultation and others checking the online survival estimates before the consultation. Adaptation: There was evidence of adaptation when using the DESIs. A lack of infrastructure, e.g. internet access, was a barrier to the use of the online tool. The brief decision aid was rarely used. Mediators: Shared decision-making: Most patients felt able to contribute to decision-making and expressed high level of satisfaction with the process. Participants’ responses to intervention: Six patients reported the DESIs to be very useful, one somewhat useful and two moderately useful.ConclusionsClinicians were mainly supportive of the interventions and had attempted some adaptations to make the interventions applicable, but there were practical and engagement barriers that led to sub-optimal adoption in routine practice.Trial Registered11th August 2016 - Retrospectively registered, http://www.isrctn.com/(ISRCTN: 46099296)

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A realist process evaluation of robot-assisted surgery: integration into routine practice and impacts on communication, collaboration and decision-making

Health Services and Delivery Research ◽

10.3310/hsdr05200 ◽

2017 ◽

Vol 5 (20) ◽

pp. 1-140 ◽

Cited By ~ 8

Author(s):

Rebecca Randell ◽

Stephanie Honey ◽

Jon Hindmarsh ◽

Natasha Alvarado ◽

Joanne Greenhalgh ◽

...

Keyword(s):

Decision Making ◽

Process Evaluation ◽

Video Recording ◽

Team Training ◽

Routine Practice ◽

Successful Implementation ◽

Robot Assisted ◽

Cancer Trial ◽

The Impact ◽

Robot Assisted Surgery

BackgroundThe implementation of robot-assisted surgery (RAS) can be challenging, with reports of surgical robots being underused. This raises questions about differences compared with open and laparoscopic surgery and how best to integrate RAS into practice.ObjectivesTo (1) contribute to reporting of the ROLARR (RObotic versus LAparoscopic Resection for Rectal cancer) trial, by investigating how variations in the implementation of RAS and the context impact outcomes; (2) produce guidance on factors likely to facilitate successful implementation; (3) produce guidance on how to ensure effective teamwork; and (4) provide data to inform the development of tools for RAS.DesignRealist process evaluation alongside ROLARR. Phase 1 – a literature review identified theories concerning how RAS becomes embedded into practice and impacts on teamwork and decision-making. These were refined through interviews across nine NHS trusts with theatre teams. Phase 2 – a multisite case study was conducted across four trusts to test the theories. Data were collected using observation, video recording, interviews and questionnaires. Phase 3 – interviews were conducted in other surgical disciplines to assess the generalisability of the findings.FindingsThe introduction of RAS is surgeon led but dependent on support at multiple levels. There is significant variation in the training provided to theatre teams. Contextual factors supporting the integration of RAS include the provision of whole-team training, the presence of handpicked dedicated teams and the availability of suitably sized operating theatres. RAS introduces challenges for teamwork that can impact operation duration, but, over time, teams develop strategies to overcome these challenges. Working with an experienced assistant supports teamwork, but experience of the procedure is insufficient for competence in RAS and experienced scrub practitioners are important in supporting inexperienced assistants. RAS can result in reduced distraction and increased concentration for the surgeon when he or she is supported by an experienced assistant or scrub practitioner.ConclusionsOur research suggests a need to pay greater attention to the training and skill mix of the team. To support effective teamwork, our research suggests that it is beneficial for surgeons to (1) encourage the team to communicate actions and concerns; (2) alert the attention of the assistant before issuing a request; and (3) acknowledge the scrub practitioner’s role in supporting inexperienced assistants. It is beneficial for the team to provide oral responses to the surgeon’s requests.LimitationsThis study started after the trial, limiting impact on analysis of the trial. The small number of operations observed may mean that less frequent impacts of RAS were missed.Future workFuture research should include (1) exploring the transferability of guidance for effective teamwork to other surgical domains in which technology leads to the physical or perceptual separation of surgeon and team; (2) exploring the benefits and challenges of including realist methods in feasibility and pilot studies; (3) assessing the feasibility of using routine data to understand the impact of RAS on rare end points associated with patient safety; (4) developing and evaluating methods for whole-team training; and (5) evaluating the impact of different physical configurations of the robotic console and team members on teamwork.FundingThe National Institute for Health Research Health Services and Delivery Research programme.

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Understanding the implementation and effectiveness of a group-based early parenting intervention: a process evaluation protocol

BMC Health Services Research ◽

10.1186/s12913-016-1737-3 ◽

2016 ◽

Vol 16 (1) ◽

Cited By ~ 7

Author(s):

Grainne Hickey ◽

Sinead McGilloway ◽

Mairead Furlong ◽

Yvonne Leckey ◽

Tracey Bywater ◽

...

Keyword(s):

Process Evaluation ◽

Parenting Intervention ◽

Early Parenting ◽

Evaluation Protocol

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Robotic surgery for renal cell carcinoma with inferior vena cava thrombosis: balancing feasibility and safety toward individualized decision-making

Minerva Urology and Nephrology ◽

10.23736/s2724-6051.21.04606-1 ◽

2021 ◽

Vol 73 (4) ◽

Author(s):

Riccardo CAMPI ◽

Michele MARCHIONI ◽

Riccardo BERTOLO ◽

Selcuk ERDEM ◽

Onder KARA ◽

...

Keyword(s):

Decision Making ◽

Renal Cell Carcinoma ◽

Robotic Surgery ◽

Inferior Vena Cava ◽

Renal Cell ◽

Inferior Vena ◽

Vena Cava ◽

Vena Cava Thrombosis ◽

Inferior Vena Cava Thrombosis ◽

Individualized Decision

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What makes it so difficult for nurses to coach patients in shared decision making? A process evaluation

International Journal of Nursing Studies ◽

10.1016/j.ijnurstu.2017.12.005 ◽

2018 ◽

Vol 80 ◽

pp. 1-11 ◽

Cited By ~ 9

Author(s):

Stephanie Anna Lenzen ◽

Ramon Daniëls ◽

Marloes Amantia van Bokhoven ◽

Trudy van der Weijden ◽

Anna Beurskens

Keyword(s):

Decision Making ◽

Shared Decision Making ◽

Process Evaluation ◽

Shared Decision

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Assessing patients’ participation and quality of decision-making: insights from a study of routine practice in diverse settings

Patient Education and Counseling ◽

10.1016/j.pec.2003.08.005 ◽

2004 ◽

Vol 55 (1) ◽

pp. 105-113 ◽

Cited By ~ 49

Author(s):

Vikki A. Entwistle ◽

Ian S. Watt ◽

Ken Gilhooly ◽

Carol Bugge ◽

Neva Haites ◽

...

Keyword(s):

Decision Making ◽

Routine Practice

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Factors affecting the embedding of integrated primary–secondary care into a health district

Australian Journal of Primary Health ◽

10.1071/py18177 ◽

2020 ◽

Vol 26 (3) ◽

pp. 216 ◽

Cited By ~ 1

Author(s):

Geoffrey K. Mitchell ◽

Charlotte E. Young ◽

Tina Janamian ◽

Kylie M. Beaver ◽

Joanne L. K. Johnson ◽

...

Keyword(s):

Health Service ◽

Integrated Care ◽

Process Evaluation ◽

Information Exchange ◽

Secondary Care ◽

Advisory Group ◽

Routine Practice ◽

Care Providers ◽

Specialist Care ◽

Structured Interviews

With the aging population, the tide of chronic disease is rising with attendant increases in health service need. Integrated care and patient-centred approaches, which established partnerships between a regional Hospital and health service (HHS), the local primary health network and local general practitioners (GPs), were identified as exemplars of an approach needed to support growing community health needs. This paper summarises the findings from a process evaluation of four GP–specialist care integration programs with the aim of identifying recommendations for embedding integrated GP–specialist care into routine practice within the HHS. The process evaluation of the integration programs drew on input from a multidisciplinary expert advisory group and data collected through face-to-face semi-structured interviews with key stakeholders, as well as surveys of participating GPs and patients. Overarching findings were identified and grouped under six themes: interdisciplinary teamwork; communication and information exchange; the use of shared care guidelines or pathways; training and education; access and accessibility; and funding. Within each theme, key challenges and enablers emerged. The findings of this study highlight benefits and challenges associated with the establishment of integrated care between primary and secondary care providers, leading to the development of key recommendations for routine integration.

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The potential of circulating tumor DNA (ctDNA) to guide adjuvant chemotherapy decision making in locally advanced rectal cancer (LARC).

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.3521 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. 3521-3521 ◽

Cited By ~ 6

Author(s):

Jeanne Tie ◽

Joshua Cohen ◽

Yuxuan Wang ◽

Lu Li ◽

Isaac Kinde ◽

...

Keyword(s):

Decision Making ◽

Rectal Cancer ◽

Adjuvant Chemotherapy ◽

Clinical Decision Making ◽

Locally Advanced ◽

Recurrence Risk ◽

Routine Practice ◽

Plasma Samples ◽

Multi Centre Study ◽

Ctdna Analysis

3521 Background: The optimal approach to adjuvant chemotherapy for rectal cancer is keenly debated. Routine practice and clinical guidelines vary widely. After pre-operative chemoradiation (CRT), a pathologic complete response (pCR) or nodal involvement (pN+) are prognostic markers that can guide clinical decision-making, but markers that better define the patients (pts) that are likely or unlikely to benefit from chemotherapy are urgently needed. We investigated the potential role of ctDNA as a biomarker to guide therapy. Methods: We conducted a prospective, multi-centre study in pts with LARC (T3/T4 and/or N+) planned for CRT and curative resection. Serial plasma samples were collected pre-CRT, post-CRT, and 4-10 weeks after surgery. Somatic mutations in individual pts’ tumor were identified via sequencing of 15 genes commonly mutated in colorectal cancers. We then designed personalized assays to quantify ctDNA in plasma samples. Pts received adjuvant therapy at clinician discretion. Results: 200 pts were enrolled between Apr-2012 and Dec-2015. Median age was 62 years (range 28-86), 67% were male and 159 pts had pre-CRT and post-op ctDNA samples available for analysis. Of these, 122 (77%) pts had detectable ctDNA prior to therapy. After surgery, 19 pts had detectable ctDNA and 11 of these 19 (58%) have recurred during a median follow up of 22 months. Recurrence occurred in only 12 of 140 (8.6%) with negative ctDNA (HR 12, p < 0.001). One hundred and two (64%) pts received adjuvant chemotherapy. Post-op ctDNA detection was predictive of recurrence irrespective of adjuvant chemotherapy (chemo: HR 10, p < 0.001; no chemo: HR 16, p < 0.001). Thirty-four pts (21%) achieved a pCR, 43 (27%) had pN+ disease. pCR (vs non-pCR) was associated with a trend for lower recurrence risk (HR 0.31, p = 0.089) and pN+ (vs pN0) with a higher recurrence risk (HR 4.2, p < 0.001). ctDNA detection remained predictive of recurrence among pts with a pCR (HR 14, p = 0.014) or with pN+ disease (HR 11, p < 0.001). Conclusions: Post-op ctDNA analysis stratifies pts with LARC into very high and low risk groups. ctDNA analysis remains strongly predictive of recurrence among pts with both lower risk (pCR) and higher risk (pN+) disease.

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Implementing a Goal-Directed Care Bundle after Acute Intracerebral Haemorrhage: Process Evaluation for the Third INTEnsive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial Study in China

Cerebrovascular Diseases ◽

10.1159/000520669 ◽

2021 ◽

pp. 1-11

Author(s):

Menglu Ouyang ◽

Craig S. Anderson ◽

Lili Song ◽

Stephen Jan ◽

Lingli Sun ◽

...

Keyword(s):

Blood Pressure ◽

Intensive Care ◽

Process Evaluation ◽

Blood Pressure Reduction ◽

Cerebral Haemorrhage ◽

Care Bundle ◽

Routine Practice ◽

Pressure Reduction ◽

Group Discussions ◽

The Third

Background: The third INTEnsive care bundle with blood pressure Reduction in Acute Cerebral Haemorrhage Trial is an ongoing international, multicentre, stepped wedge, cluster-randomized trial to determine the effectiveness of a goal-directed care bundle (early intensive blood pressure [BP] lowering, glycaemic control, treatment of pyrexia, and reversal of anticoagulation), as compared to standard of care, on patient-centred outcomes after acute intracerebral haemorrhage (ICH). An embedded process evaluation aims to identify factors related to the uptake and implementation of the intervention. Herein, we present the process evaluation results for hospital sites in China. Methods/Design: A mixed methods approach, including surveys, focused group discussions and interviews with clinicians, routine monitoring, and recruitment logs were used to collect data across purposively sampled hospitals. Medical Research Council guidance and normalization process theory were used as theoretical frameworks for design, data analysis, and synthesis. Results: Twenty quantitative surveys were completed with clinicians, and 26 interviews and 2 focus group discussions were conducted during 2019–2020. The care bundle was generally delivered as planned and acceptable by doctors and nurses, but difficulties were reported in achieving the protocol-defined target levels of BP and glycaemic control. Resistance to implementing the care bundle occurred for patients perceived to be at high risk of adverse effects. Common organizational contextual factors that impeded implementation included delayed processes and limited medication supply, while established background care procedures, expertise, and capacity influenced its integration into routine practice. Areas to facilitate implementation included optimizing workflow within available resources, having a dedicated team, and recognizing the potential benefits of the intervention. Conclusions: Varied established care protocols across sites, different levels of background expertise, and lack of staff capacity impeded the integration of goal-directed care bundle into routine practice for ICH patients in China. Ready identification, and efforts to address, these barriers could facilitate uptake of future guideline-recommended interventions for the management of patients with ICH.

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