Routine provision of feedback from patient-reported outcome measurements to healthcare providers and patients in clinical practice.

BACKGROUND: Patient-reported outcomes measures (PROMs) assess a patient's subjective appraisal of health outcomes from their own perspective. Despite hypothesised benefits that feedback  on PROMs can support decision-making in clinical practice and improve outcomes, there is uncertainty surrounding the effectiveness of PROMs feedback. OBJECTIVES: To assess the effects of PROMs feedback to patients, or healthcare workers, or both on patient-reported health outcomes and processes of care. SEARCH METHODS: We searched MEDLINE, Embase, CENTRAL, two other databases and two clinical trial registries on 5 October 2020. We searched grey literature and consulted experts in the field. SELECTION CRITERIA: Two review authors independently screened and selected studies for inclusion. We included randomised trials directly comparing the effects on outcomes and processes of care of PROMs feedback to healthcare professionals and patients, or both with the impact of not providing such information. DATA COLLECTION AND ANALYSIS: Two groups of two authors independently extracted data from the included studies and evaluated study quality. We followed standard methodological procedures expected by Cochrane and EPOC. We used the GRADE approach to assess the certainty of the evidence. We conducted meta-analyses of the results where possible. MAIN RESULTS: We identified 116 randomised trials which assessed the effectiveness of PROMs feedback in improving processes or outcomes of care, or both in a broad range of disciplines including psychiatry, primary care, and oncology. Studies were conducted across diverse ambulatory primary and secondary care settings in North America, Europe and Australasia. A total of 49,785 patients were included across all the studies. The certainty of the evidence varied between very low and moderate. Many of the studies included in the review were at risk of performance and detection bias. The evidence suggests moderate certainty that PROMs feedback probably improves quality of life (standardised mean difference (SMD) 0.15, 95% confidence interval (CI) 0.05 to 0.26; 11 studies; 2687 participants), and leads to an increase in patient-physician communication (SMD 0.36, 95% CI 0.21 to 0.52; 5 studies; 658 participants), diagnosis and notation (risk ratio (RR) 1.73, 95% CI 1.44 to 2.08; 21 studies; 7223 participants), and disease control (RR 1.25, 95% CI 1.10 to 1.41; 14 studies; 2806 participants). The intervention probably makes little or no difference for general health perceptions (SMD 0.04, 95% CI -0.17 to 0.24; 2 studies, 552 participants; low-certainty evidence), social functioning (SMD 0.02, 95% CI -0.06 to 0.09; 15 studies; 2632 participants; moderate-certainty evidence), and pain (SMD 0.00, 95% CI -0.09 to 0.08; 9 studies; 2386 participants; moderate-certainty evidence). We are uncertain about the effect of PROMs feedback on physical functioning (14 studies; 2788 participants) and mental functioning (34 studies; 7782 participants), as well as fatigue (4 studies; 741 participants), as the certainty of the evidence was very low. We did not find studies reporting on adverse effects defined as distress following or related to PROM completion. AUTHORS' CONCLUSIONS: PROM feedback probably produces moderate improvements in communication between healthcare professionals and patients as well as in diagnosis and notation, and disease control, and small improvements to quality of life. Our confidence in the effects is limited by the risk of bias, heterogeneity and small number of trials conducted to assess outcomes of interest. It is unclear whether   many of these improvements are clinically meaningful or sustainable in the long term. There is a need for more high-quality studies in this area, particularly studies which employ cluster designs and utilise techniques to maintain allocation concealment.

How do team experience and relationships shape new divisions of labour in robot-assisted surgery? A realist investigation.

Safe and successful surgery depends on effective teamwork between professional groups, each playing their part in a complex division of labour. This article reports the first empirical examination of how introduction of robot-assisted surgery changes the division of labour within surgical teams and impacts teamwork and patient safety. Data collection and analysis was informed by realist principles. Interviews were conducted with surgical teams across nine UK hospitals and, in a multi-site case study across four hospitals, data were collected using a range of methods, including ethnographic observation, video recording and semi-structured interviews. Our findings reveal that as the robot enables the surgeon to do more, the surgical assistant's role becomes less clearly defined. Robot-assisted surgery also introduces new tasks for the surgical assistant and scrub practitioner, in terms of communicating information to the surgeon. However, the use of robot-assisted surgery does not redistribute work in a uniform way; contextual factors of individual experience and team relationships shape changes to the division of labour. For instance, in some situations, scrub practitioners take on the role of supporting inexperienced surgical assistants. These changes in the division of labour do not persist when team members return to operations that are not robot-assisted. This study contributes to wider literature on divisions of labour in healthcare and how this is impacted by the introduction of new technologies. In particular, we emphasise the need to pay attention to often neglected micro-level contextual factors. This can highlight behaviours that can be promoted to benefit patient care.

Using an implementation science approach to implement and evaluate patient-reported outcome measures (PROM) initiatives in routine care settings.

PURPOSE: Patient-reported outcome and experience measures (PROMs/PREMs) are well established in research for many health conditions, but barriers persist for implementing them in routine care. Implementation science (IS) offers a potential way forward, but its application has been limited for PROMs/PREMs. METHODS: We compare similarities and differences for widely used IS frameworks and their applicability for implementing PROMs/PREMs through case studies. Three case studies implemented PROMs: (1) pain clinics in Canada; (2) oncology clinics in Australia; and (3) pediatric/adult clinics for chronic conditions in the Netherlands. The fourth case study is planning PREMs implementation in Canadian primary care clinics. We compare case studies on barriers, enablers, implementation strategies, and evaluation. RESULTS: Case studies used IS frameworks to systematize barriers, to develop implementation strategies for clinics, and to evaluate implementation effectiveness. Across case studies, consistent PROM/PREM implementation barriers were technology, uncertainty about how or why to use PROMs/PREMs, and competing demands from established clinical workflows. Enabling factors in clinics were context specific. Implementation support strategies changed during pre-implementation, implementation, and post-implementation stages. Evaluation approaches were inconsistent across case studies, and thus, we present example evaluation metrics specific to PROMs/PREMs. CONCLUSION: Multilevel IS frameworks are necessary for PROM/PREM implementation given the complexity. In cross-study comparisons, barriers to PROM/PREM implementation were consistent across patient populations and care settings, but enablers were context specific, suggesting the need for tailored implementation strategies based on clinic resources. Theoretically guided studies are needed to clarify how, why, and in what circumstances IS principles lead to successful PROM/PREM integration and sustainability.

Factors supporting and constraining the implementation of robot-assisted surgery: a realist interview study.

OBJECTIVE: To capture stakeholders' theories concerning how and in what contexts robot-assisted surgery becomes integrated into routine practice. DESIGN: A literature review provided tentative theories that were revised through a realist interview study. Literature-based theories were presented to the interviewees, who were asked to describe to what extent and in what ways those theories reflected their experience. Analysis focused on identifying mechanisms through which robot-assisted surgery becomes integrated into practice and contexts in which those mechanisms are triggered. SETTING: Nine hospitals in England where robot-assisted surgery is used for colorectal operations. PARTICIPANTS: Forty-four theatre staff with experience of robot-assisted colorectal surgery, including surgeons, surgical trainees, theatre nurses, operating department practitioners and anaesthetists. RESULTS: Interviewees emphasised the importance of support from hospital management, team leaders and surgical colleagues. Training together as a team was seen as beneficial, increasing trust in each other's knowledge and supporting team bonding, in turn leading to improved teamwork. When first introducing robot-assisted surgery, it is beneficial to have a handpicked dedicated robotic team who are able to quickly gain experience and confidence. A suitably sized operating theatre can reduce operation duration and the risk of de-sterilisation. Motivation among team members to persist with robot-assisted surgery can be achieved without involvement in the initial decision to purchase a robot, but training that enables team members to feel confident as they take on the new tasks is essential. CONCLUSIONS: We captured accounts of how robot-assisted surgery has been introduced into a range of hospitals. Using a realist approach, we were also able to capture perceptions of the factors that support and constrain the integration of robot-assisted surgery into routine practice. We have translated these into recommendations that can inform future implementations of robot-assisted surgery.

How do patient reported outcome measures (PROMs) support clinician-patient communication and patient care? A realist synthesis.

BACKGROUND: In this paper, we report the findings of a realist synthesis that aimed to understand how and in what circumstances patient reported outcome measures (PROMs) support patient-clinician communication and subsequent care processes and outcomes in clinical care. We tested two overarching programme theories: (1) PROMs completion prompts a process of self-reflection and supports patients to raise issues with clinicians and (2) PROMs scores raise clinicians' awareness of patients' problems and prompts discussion and action. We examined how the structure of the PROM and care context shaped the ways in which PROMs support clinician-patient communication and subsequent care processes. RESULTS: PROMs completion prompts patients to reflect on their health and gives them permission to raise issues with clinicians. However, clinicians found standardised PROMs completion during patient assessments sometimes constrained rather than supported communication. In response, clinicians adapted their use of PROMs to render them compatible with the ongoing management of patient relationships. Individualised PROMs supported dialogue by enabling the patient to tell their story. In oncology, PROMs completion outside of the consultation enabled clinicians to identify problematic symptoms when the PROM acted as a substitute rather than addition to the clinical encounter and when the PROM focused on symptoms and side effects, rather than health related quality of life (HRQoL). Patients did not always feel it was appropriate to discuss emotional, functional or HRQoL issues with doctors and doctors did not perceive this was within their remit. CONCLUSIONS: This paper makes two important contributions to the literature. First, our findings show that PROMs completion is not a neutral act of information retrieval but can change how patients think about their condition. Second, our findings reveal that the ways in which clinicians use PROMs is shaped by their relationships with patients and professional roles and boundaries. Future research should examine how PROMs completion and feedback shapes and is influenced by the process of building relationships with patients, rather than just their impact on information exchange and decision making.

What's in a mechanism? Development of a key concept in realist evaluation.

BACKGROUND: The idea that underlying, generative mechanisms give rise to causal regularities has become a guiding principle across many social and natural science disciplines. A specific form of this enquiry, realist evaluation is gaining momentum in the evaluation of complex social interventions. It focuses on 'what works, how, in which conditions and for whom' using context, mechanism and outcome configurations as opposed to asking whether an intervention 'works'. Realist evaluation can be difficult to codify and requires considerable researcher reflection and creativity. As such there is often confusion when operationalising the method in practice. This article aims to clarify and further develop the concept of mechanism in realist evaluation and in doing so aid the learning of those operationalising the methodology. DISCUSSION: Using a social science illustration, we argue that disaggregating the concept of mechanism into its constituent parts helps to understand the difference between the resources offered by the intervention and the ways in which this changes the reasoning of participants. This in turn helps to distinguish between a context and mechanism. The notion of mechanisms 'firing' in social science research is explored, with discussions surrounding how this may stifle researchers' realist thinking. We underline the importance of conceptualising mechanisms as operating on a continuum, rather than as an 'on/off' switch. The discussions in this article will hopefully progress and operationalise realist methods. This development is likely to occur due to the infancy of the methodology and its recent increased profile and use in social science research. The arguments we present have been tested and are explained throughout the article using a social science illustration, evidencing their usability and value.

Impact of Robotic Surgery on Decision Making: Perspectives of Surgical Teams.

There has been rapid growth in the purchase of surgical robots in both North America and Europe in recent years. Whilst this technology promises many benefits for patients, the introduction of such a complex interactive system into healthcare practice often results in unintended consequences that are difficult to predict. Decision making by surgeons during an operation is affected by variables including tactile perception, visual perception, motor skill, and instrument complexity, all of which are changed by robotic surgery, yet the impact of robotic surgery on decision making has not been previously studied. Drawing on the approach of realist evaluation, we conducted a multi-site interview study across nine hospitals, interviewing 44 operating room personnel with experience of robotic surgery to gather their perspectives on how robotic surgery impacts surgeon decision making. The findings reveal both potential benefits and challenges of robotic surgery for decision making.

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

BACKGROUND: Robotic 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 DESIGN: We 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.

Surgeon's experiences of receiving peer benchmarked feedback using patient-reported outcome measures: a qualitative study.

BACKGROUND: The use of patient-reported outcome measures (PROMs) to provide healthcare professionals with peer benchmarked feedback is growing. However, there is little evidence on the opinions of professionals on the value of this information in practice. The purpose of this research is to explore surgeon's experiences of receiving peer benchmarked PROMs feedback and to examine whether this information led to changes in their practice. METHODS: This qualitative research employed a Framework approach. Semi-structured interviews were undertaken with surgeons who received peer benchmarked PROMs feedback. The participants included eleven consultant orthopaedic surgeons in the Republic of Ireland. RESULTS: Five themes were identified: conceptual, methodological, practical, attitudinal, and impact. A typology was developed based on the attitudinal and impact themes from which three distinct groups emerged. 'Advocates' had positive attitudes towards PROMs and confirmed that the information promoted a self-reflective process. 'Converts' were uncertain about the value of PROMs, which reduced their inclination to use the data. 'Sceptics' had negative attitudes towards PROMs and claimed that the information had no impact on their behaviour. The conceptual, methodological and practical factors were linked to the typology. CONCLUSION: Surgeons had mixed opinions on the value of peer benchmarked PROMs data. Many appreciated the feedback as it reassured them that their practice was similar to their peers. However, PROMs information alone was considered insufficient to help identify opportunities for quality improvements. The reasons for the observed reluctance of participants to embrace PROMs can be categorised into conceptual, methodological, and practical factors. Policy makers and researchers need to increase professionals' awareness of the numerous purposes and benefits of using PROMs, challenge the current methods to measure performance using PROMs, and reduce the burden of data collection and information dissemination on routine practice.

How do doctors refer to patient-reported outcome measures (PROMS) in oncology consultations?

PURPOSE: We conducted a secondary qualitative analysis of consultations between oncologists and their patients to explore how patient-reported outcome measures (PROMs) data were referred to in the process of (1) eliciting and exploring patients' concerns; (2) making decisions about supportive treatment and (3) making decisions about chemotherapy and other systemic treatments. METHODS: We purposively sampled audio recordings of 18 consultations from the intervention arm and 4 from the attention control arm of a previous UK randomised controlled trial of the feedback of PROMs data to doctors (Velikova et al. in J Clin Oncol 22(4):714-724 [1]). We used a combination of content and conversation analysis to examine how opportunities for discussion of health-related quality of life issues are opened up or closed down within the consultation and explore why this may or may not lead to changes in patient management. FINDINGS: Explicit reference to the PROMs data provided an opportunity for the patient to clarify and further elaborate on the side effects of chemotherapy. High scores on the PROMs data were not explored further if the patient indicated they were not a problem or were not related to the cancer or chemotherapy. Symptomatic treatment was more often offered for problems like nausea, constipation, pain and depression but much less so for fatigue. Doctors discussed fatigue by providing a cause for the fatigue (e.g. the chemotherapy), presenting this as 'something to be expected', minimising its impact or moving on to another topic. Chemotherapy regimens were not changed on the basis of the PROMs data alone, but PROMs data were sometimes used to legitimise changes. CONCLUSIONS: Explicit mention of PROMs data in the consultation may strengthen opportunities for patients to elaborate on their problems, but doctors may not always know how to do this. Our findings have informed the development of a training package to enable doctors to optimise their use of PROMs data within the consultation.