Examining the application of the IDEAL framework in the reporting and evaluation of innovative invasive procedures: secondary qualitative analysis of a systematic review.

OBJECTIVES: The development of new surgical procedures is fundamental to advancing patient care. The Idea, Developments, Exploration, Assessment and Long-term (IDEAL) framework describes study designs for stages of innovation. It can be difficult to apply due to challenges in defining and identifying innovative procedures. This study examined how the IDEAL framework is operationalised in real-world settings; specifically, the types of innovations evaluated using the framework and how authors justify their choice of IDEAL study design. DESIGN: Secondary qualitative analysis of a systematic review. DATA SOURCES: Citation searches (Web of Science and Scopus) identified studies following the IDEAL framework and citing any of the ten key IDEAL/IDEAL_D papers. ELIGIBILITY CRITERIA: Studies of invasive procedures/devices of any design citing any of the ten key IDEAL/IDEAL_D papers. DATA EXTRACTION AND SYNTHESIS: All relevant text was extracted. Three frameworks were developed, namely: (1) type of innovation under evaluation; (2) terminology used to describe stage of innovation and (3) reported rationale for IDEAL stage. RESULTS: 48 articles were included. 19/48 described entirely new procedures, including those used for the first time in a different clinical context (n=15/48), reported as IDEAL stage 2a (n=8, 53%). Terminology describing stage of innovation was varied, inconsistent and ambiguous and was not defined. Authors justified their choice of IDEAL study design based on limitations in published evidence (n=36) and unknown feasibility and safety (n=32) outcomes. CONCLUSION: Identifying stage of innovation is crucial to inform appropriate study design and governance decisions. Authors' rationale for choice of IDEAL stage related to the existing evidence base or lack of sufficient outcome data for procedures. Stage of innovation was poorly defined with inconsistent descriptions. Further work is needed to develop methods to identify innovation to inform practical application of the IDEAL framework. Defining the concept of innovation in terms of uncertainty, risk and degree of evidence may help to inform decision-making.

Qualitative documentary analysis of guidance on information provision and consent for the introduction of innovative invasive procedures including surgeries within NHS organisations' policies in England and Wales.

OBJECTIVE: To review guidance, included in written local UK National Health Service (NHS) organisation policies, on information provision and consent for the introduction of new invasive procedures- including surgeries, and devices (IPs/Ds). DESIGN: A qualitative documentary analysis of data on patient information provision and consent extracted from policies for the introduction of IP/Ds from NHS organisations in England and Wales. SETTING: NHS trusts in England and health boards in Wales, UK. PARTICIPANTS: Between December 2017 and July 2018, 150 acute trusts in England and 7 health boards in Wales were approached for their policies for the introduction of new IP/Ds. In total, 123 policies were received, 11 did not fit the inclusion criteria and a further policy was included from a trust website resulting in 113 policies included for review. RESULTS: From the 113 policies, 22 did not include any statements on informed consent/information provision or lacked guidance on the information to be provided to patients and were hence excluded. Consequently, 91 written local NHS policies were included in the final dataset. Within the guidance obtained, variation existed on disclosure of the procedure's novelty, potential risks, benefits, uncertainties, alternative treatments and surgeon's experience. Few policies stated that clinicians should discuss the existing evidence associated with a procedure. Additionally, while the majority of policies referred to patients needing written information, this was often not mandated and few policies specified the information to be included. CONCLUSIONS: Nearly a fifth of all the policies lacked guidance on information to be provided to patients. There was variability in the policy documents regarding what patients should be told about innovative procedures. Further research is needed to ascertain the information and level of detail appropriate for patients when considering innovative procedures. A core information set including patients' and clinicians' views is required to address variability around information provision/consent for innovative procedures.

Healthcare organization policy recommendations for the governance of surgical innovation: review of NHS policies.

BACKGROUND: The governance for introducing innovative surgical procedures/devices differs from the research requirements needed for new drugs. New invasive procedures/devices may be offered to patients outside of research protocols with local organization oversight alone. Such institutional arrangements exist in many countries and written policies provide guidance for their use, but little is known about their scope or standards. METHODS: One hundred and fifty acute NHS trusts in England and seven health boards in Wales were systematically approached for information about their policies. A modified framework approach was used to analyse when policies considered new procedures/devices to be within local organization remit and/or requiring research ethics committee (REC) approval. RESULTS: Of 113 policies obtained, 109 and 34 described when local organization and REC approval was required, respectively. Procedures/devices being used for the first time in the organization (n = 69) or by a clinician (n = 67) were commonly within local remit, and only 36 stated that evidence was required. Others stated limited evidence as a rationale for needing REC approval (n = 13). External guidance categorizing procedures as 'research only' was the most common reason for gaining REC approval (n = 15). Procedures/devices with uncertain outcomes (n = 28), requiring additional training (n = 26), and not previously used (n = 6) were within the remit of policies, while others recommended REC application in these situations (n = 5, 2 and 7, respectively). CONCLUSION: This study on NHS policies for surgical innovation shows variability in the introduction of procedures/devices in terms of local oversight and/or need for REC approval. Current NHS standards allow untested innovations to occur without the safety of research oversight and thus a standard approach is urgently needed.

Protocol for a Global Burns Research Priority Setting Partnership to agree the most important unanswered questions in international burns care.

INTRODUCTION: Burns affect 11 million people globally and can result in long-term disability with substantial associated healthcare costs. There is limited research funding to support trials to provide evidence for clinical decision-making. Research prioritisation ensures that research focuses on the topics most important to stakeholders, addressing issues of research waste and evidence gaps. The aim of this project is to agree the global top 10 research priorities important to international patients, carers and clinicians from all income status countries. METHODS AND ANALYSIS: The Global Burns Research Priority Setting Partnership will use James Lind Alliance methods to establish the top 10 research priorities in global burns care. An initial international online multilingual survey will collect candidate research priorities from stakeholders. To increase equity in participation, the survey will also be available via the social media app WhatsApp. Additionally, interviews will be conducted. Data will be analysed to identify and collate research questions and to verify that the priorities are true clinical uncertainties. This list will then be ranked by stakeholders in order of importance via a second online survey. Finally, a consensus meeting will identify the top 10 research priorities. ETHICS AND DISSEMINATION: The University of Bristol Medical School Faculty Ethical Committee has approved this project. Research into burn care should be prioritised to ensure that funding is focused where most needed. This should be undertaken internationally, to ensure inclusion of the views of professionals and patients from lower income countries, where the incidence of thermal burns is highest. The involvement of the James Lind Alliance will ensure that the methodology is robust and that the patient voice is heard. The final top 10 priorities will be disseminated to funders, governments and researchers internationally to inform future global burns research.

Using qualitative research methods to understand how surgical procedures and devices are introduced into NHS hospitals: the Lotus study protocol.

INTRODUCTION: The development of innovative invasive procedures and devices are essential to improving outcomes in healthcare. However, how these are introduced into practice has not been studied in detail. The Lotus study will follow a wide range of 'case studies' of new procedures and/or devices being introduced into NHS trusts to explore what information is communicated to patients, how procedures are modified over time and how outcomes are selected and reported. METHODS AND ANALYSIS: This qualitative study will use ethnographic approaches to investigate how new invasive procedures and/or devices are introduced. Consultations in which the innovation is discussed will be audio-recorded to understand information provision practice. To understand if and how procedures evolve, they will be video recorded and non-participant observations will be conducted. Post-operative interviews will be conducted with the innovating team and patients who are eligible for the intervention. Audio-recordings will be audio-recorded, transcribed verbatim and analysed thematically using constant comparison techniques. Video-recordings will be reviewed to deconstruct procedures into key components and document how the procedure evolves. Comparisons will be made between the different data sources. ETHICS AND DISSEMINATION: The study protocol has Health Research Authority (HRA) and Health and Care Research Wales approval (Ref 18/SW/0277). Results will be disseminated at appropriate conferences and will be published in peer-reviewed journals. The findings of this study will provide a better understanding of how innovative invasive procedures and/or devices are introduced into practice.

Introduction and adoption of innovative invasive procedures and devices in the NHS: an in-depth analysis of written policies and qualitative interviews (the INTRODUCE study protocol).

INTRODUCTION: Innovation is key to improving outcomes in healthcare. Innovative pharmaceutical products undergo rigorous phased research evaluation before they are introduced into practice. The introduction of innovative invasive procedures and devices is much less rigorous and phased research, including randomised controlled trials, is not always undertaken. While the innovator (usually a surgeon) may introduce a new or modified procedure/device within the context of formal research, they may also be introduced by applying for local National Health Service (NHS) organisation approval alone. Written policies for the introduction of new procedures and/or devices often form part of this local clinical governance infrastructure; however, little is known about their content or use in practice. This study aims to systematically investigate how new invasive procedures and devices are introduced in NHS England and Wales. METHODS AND ANALYSIS: An in-depth analysis of written policies will be undertaken. This will be supplemented with interviews with key stakeholders. All acute NHS trusts in England and Health Boards in Wales will be systematically approached and asked to provide written policies for the introduction of new invasive procedures and devices. Information on the following will be captured: (1) policy scope, including when new procedures should be introduced within a formal research framework; (2) requirements for patient information provision; (3) outcome reporting and/or monitoring. Data will be extracted using a standardised form developed iteratively within the study team. Semistructured interviews with medical directors, audit and governance leads, and surgeons will explore views regarding the introduction of new invasive procedures into practice, including knowledge of and implementation of current policies. ETHICS AND DISSEMINATION: In-depth analysis of written policies does not require ethics approval. The University of Bristol Ethics Committee (56522) approved the interview component of the study. Findings from this work will be presented at appropriate conferences and will be published in peer-reviewed journals.

Developing a real-time electronic symptom monitoring system for patients after discharge following cancer-related surgery.

BACKGROUND: Patients undergoing major cancer surgery frequently require post-acute care for complications and adverse effects. Enhanced recovery after surgery programmes mean that patients are increasingly discharged home earlier. Symptom/complication detection post-discharge is sub-optimal. Systematic patient monitoring post-discharge following surgery may be optimally achieved through routine electronic patient-reported outcome (ePRO) data capture. ePRO systems that employ clinical algorithms to guide management of patients and automatically alert clinicians of clinically-concerning symptoms can improve patient outcomes and decrease hospital admissions. ePRO systems that provide individually-tailored self-management advice and integrate live ePRO data into electronic health records (EHR) may also advance personalised health and patient-centred care. This study aims to develop a hospital EHR-integrated ePRO system to improve detection and management of complications post-discharge following cancer-related surgery. METHODS: The ePRO system was developed in two phases: (1) Development of a web-based ePRO symptom-report from validated European Organisation for Research and Treatment of Cancer (EORTC) questionnaires, clinical opinion and patient interviews, followed by hospital EHR integration; (2) Development of clinical algorithms triggering symptom severity-dependent patient advice and clinician alerts from: (i) prospectively-collected patient-completed ePRO symptom-report data; (ii) stakeholder meetings; (iii) patient interviews. Patient advice was developed from: (i) clinician-patient telephone consultations and patient interviews; (ii) review of hospital patient information leaflets (PIL) and patient support websites. RESULTS: Phase 1, including interviews with 18 patients, identified 35 symptom-report items. In phase 2, 130/300 (43%) screened patients were eligible. 61 (47%) consented to participate and 59 (97%) provided 444 complete self-reports. Stakeholder meetings (9 clinicians, 1 patient/public representative) and patient interviews (n = 66) refined advice/alert accuracy. 15 telephone consultations, 7 patient interviews and review of 28 PILs and 3 patient support websites identified 4 themes to inform self-management advice. Comparisons between ePRO symptom-report data, telephone consultations and clinical events/outcomes (n = 27 patients) further refined clinical algorithms. CONCLUSIONS: A hospital EHR-integrated ePRO system that alerts clinicians and provides patient self-management advice has been developed to improve the detection and management of problems and complications after discharge following surgery. An ongoing pilot study will inform a multicentre randomised trial to evaluate the effectiveness of the ePRO system compared to usual care.

Pre-operative experiences and post-operative benefits of ptosis surgery: A qualitative study.

This qualitative study sought to explore the experiences of patients who had undergone successful ptosis correction surgery. Participants were recruited from Bristol Eye Hospital. Nine participants were interviewed using a semi-structured interview schedule and open ended questions. Data were analysed using inductive thematic analysis. Four major themes were identified from patient accounts. Patients described the psychosocial and functional difficulties they experienced living with ptosis, and the subsequent benefits of surgery. Patients reported experiencing appearance related anxiety pre-operatively due to their condition and engaging in behaviours to avoid social encounters. Gender differences were noted in the internalization of perceived negative reactions from others, with men describing fewer adverse impacts. Patients described perceived barriers to seeking surgery including a lack of awareness of ptosis as a treatable condition, the perception that being concerned with their appearance could be seen as vain and the view that ptosis surgery is synonymous with cosmetic surgery. Following successful surgery patients outlined positive impacts on their vision, appearance and psychosocial well-being after successful surgery. This qualitative study highlights the complexities of the factors and processes contributing to the psychosocial impacts of ptosis and the potential benefits of surgery and/or psychosocial support. An increased awareness amongst people with ptosis of the potential positive impacts of surgery and an enhanced understanding of the reasons why patients may not seek treatment amongst health care professionals are likely to benefit this often overlooked patient group.

The psychosocial impact of ptosis as a symptom of Myasthenia Gravis: a qualitative study.

The aim of this qualitative study was to investigate the psychosocial impact of ptosis as a symptom of Myasthenia Gravis (MG). Participants were recruited from a MG patient group on Facebook. 166 participants answered a series of open ended questions examining the impact of ptosis, and responses were analysed using Inductive Thematic Analysis, which revealed four main themes. The first highlighted the extent to which ptosis impacted negatively on psychosocial functioning. The second related to ways in which ptosis can be framed in a positive way, eg, as a believable symptom. The final two themes revealed the complex inter-relationships between functional and appearance-related impacts, and a desire from many participants for health care professionals to provide more support directly related to their ptosis. This study suggests that ptosis impacts in ways not currently recognized in literature and practice.