Usability of an Automated System for Real-Time Monitoring of Shared Decision-Making for Surgery: Mixed Methods Evaluation.

BACKGROUND: Improving shared decision-making (SDM) for patients has become a health policy priority in many countries. Achieving high-quality SDM is particularly important for approximately 313 million surgical treatment decisions patients make globally every year. Large-scale monitoring of surgical patients' experience of SDM in real time is needed to identify the failings of SDM before surgery is performed. We developed a novel approach to automating real-time data collection using an electronic measurement system to address this. Examining usability will facilitate its optimization and wider implementation to inform interventions aimed at improving SDM. OBJECTIVE: This study examined the usability of an electronic real-time measurement system to monitor surgical patients' experience of SDM. We aimed to evaluate the metrics and indicators relevant to system effectiveness, system efficiency, and user satisfaction. METHODS: We performed a mixed methods usability evaluation using multiple participant cohorts. The measurement system was implemented in a large UK hospital to measure patients' experience of SDM electronically before surgery using 2 validated measures (CollaboRATE and SDM-Q-9). Quantitative data (collected between April 1 and December 31, 2021) provided measurement system metrics to assess system effectiveness and efficiency. We included adult patients booked for urgent and elective surgery across 7 specialties and excluded patients without the capacity to consent for medical procedures, those without access to an internet-enabled device, and those undergoing emergency or endoscopic procedures. Additional groups of service users (group 1: public members who had not engaged with the system; group 2: a subset of patients who completed the measurement system) completed user-testing sessions and semistructured interviews to assess system effectiveness and user satisfaction. We conducted quantitative data analysis using descriptive statistics and calculated the task completion rate and survey response rate (system effectiveness) as well as the task completion time, task efficiency, and relative efficiency (system efficiency). Qualitative thematic analysis identified indicators of and barriers to good usability (user satisfaction). RESULTS: A total of 2254 completed surveys were returned to the measurement system. A total of 25 service users (group 1: n=9; group 2: n=16) participated in user-testing sessions and interviews. The task completion rate was high (169/171, 98.8%) and the survey response rate was good (2254/5794, 38.9%). The median task completion time was 3 (IQR 2-13) minutes, suggesting good system efficiency and effectiveness. The qualitative findings emphasized good user satisfaction. The identified themes suggested that the measurement system is acceptable, easy to use, and easy to access. Service users identified potential barriers and solutions to acceptability and ease of access. CONCLUSIONS: A mixed methods evaluation of an electronic measurement system for automated, real-time monitoring of patients' experience of SDM showed that usability among patients was high. Future pilot work will optimize the system for wider implementation to ultimately inform intervention development to improve SDM. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1136/bmjopen-2023-079155.

Clinical outcome measures and their evidence base in degenerative cervical myelopathy: a systematic review to inform a core measurement set (AO Spine RECODE-DCM).

OBJECTIVES: To evaluate the measurement properties of outcome measures currently used in the assessment of degenerative cervical myelopathy (DCM) for clinical research. DESIGN: Systematic review DATA SOURCES: MEDLINE and EMBASE were searched through 4 August 2020. ELIGIBILITY CRITERIA: Primary clinical research published in English and whose primary purpose was to evaluate the measurement properties or clinically important differences of instruments used in DCM. DATA EXTRACTION AND SYNTHESIS: Psychometric properties and clinically important differences were both extracted from each study, assessed for risk of bias and presented in accordance with the Consensus-based Standards for the selection of health Measurement Instruments criteria. RESULTS: Twenty-nine outcome instruments were identified from 52 studies published between 1999 and 2020. They measured neuromuscular function (16 instruments), life impact (five instruments), pain (five instruments) and radiological scoring (five instruments). No instrument had evaluations for all 10 measurement properties and <50% had assessments for all three domains (ie, reliability, validity and responsiveness). There was a paucity of high-quality evidence. Notably, there were no studies that reported on structural validity and no high-quality evidence that discussed content validity. In this context, we identified nine instruments that are interpretable by clinicians: the arm and neck pain scores; the 12-item and 36-item short form health surveys; the Japanese Orthopaedic Association (JOA) score, modified JOA and JOA Cervical Myelopathy Evaluation Questionnaire; the neck disability index; and the visual analogue scale for pain. These include six scores with barriers to application and one score with insufficient criterion and construct validity. CONCLUSIONS: This review aggregates studies evaluating outcome measures used to assess patients with DCM. Overall, there is a need for a set of agreed tools to measure outcomes in DCM. These findings will be used to inform the development of a core measurement set as part of AO Spine RECODE-DCM.

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.

Prevailing Outcome Themes Reported by People With Degenerative Cervical Myelopathy: Focus Group Study.

BACKGROUND: Degenerative cervical myelopathy (DCM) arises when arthritic changes of the cervical spine cause compression and a progressive injury to the spinal cord. It is common and potentially disabling. People with DCM have among the lowest quality of life scores (Short Form Health Survey-36 item [SF-36]) of chronic disease, although the drivers of the imapact of DCM are not entirely understood. DCM research faces a number of challenges, including the heterogeneous reporting of study data. The AO Spine Research Objectives and Common Data Elements for Degenerative Cervical Myelopathy (RECODE-DCM) project is an international consensus process that aims to improve research efficiency through formation of a core outcome set (COS). A key part of COS development process is organizing outcomes into domains that represent key aspects of the disease. To facilitate this, we sought to qualitatively explore the context and impact of patient-reported outcomes in DCM on study participants. OBJECTIVE: The goal of the research was to qualitatively explore the patient-reported outcomes in DCM to improve understanding of patient perspective and assist the organization of outcomes into domains for the consensus process. METHODS: Focus group sessions were hosted in collaboration with Myelopathy.org, a charity and support group for people with DCM. A 40-minute session was audiorecorded and transcribed verbatim. Two authors familiarized themselves with the data and then performed data coding independently. Codes were grouped into themes and a thematic analysis was performed guided by Braun and Clarke's 6-phase approach. The themes were subsequently reviewed with an independent stakeholder with DCM, assisting in the process of capturing the true context and importance of themes. RESULTS: Five people with DCM (3 men and 2 women) participated in the focus group session. The median age was 53 years, and the median score on the modified Japanese Orthopaedic Association scale was 11 (interquartile range 9.5-11.5), indicating the participants had moderate to severe DCM. A total of 54 codes were reviewed and grouped into 10 potential themes that captured the impact of the disability on people with DCM: acceptance of symptoms, anticipatory anxiety, coping mechanisms/resilience, feelings of helplessness, financial consequences, lack of recognition, mental health impact, loss of life control, social reclusiveness and isolation, and social stigma. CONCLUSIONS: This qualitative analysis of the perspectives of people with DCM has highlighted a number of prevailing themes currently unmeasured in clinical research or care. The determinants of low quality of life in DCM are currently unknown, and these findings provide a novel and so far, unique perspective. Continued inclusion of online communities and use of targeted digital software will be important in establishing a consensus-based COS for patients with DCM that is inclusive of all relevant stakeholders including people with DCM.

Investigating the collection and assessment of patient-reported outcome data amongst unplanned surgical hospital admissions: a feasibility study.

BACKGROUND: Randomised controlled trials (RCTs) in surgery can be challenging to conduct, and trials in the emergency surgical setting when patients have unplanned hospital admissions are particularly difficult. One area of challenge is capturing baseline patient-reported outcome (PRO) data. This study examined the feasibility and optimal methods for the collection of baseline and follow-up PRO data in the setting of unplanned surgical hospital admissions. METHODS: Clinically stable adult patients with unplanned admissions through the day and night under the care of general surgeons at two acute NHS trusts were approached during working week days and asked to complete validated PRO measures (European Quality of Life-5 Dimension, Short Form-12, and Gastrointestinal Quality of Life Index) on admission and 6 weeks following discharge. Feasibility of PRO data collection was determined by the proportions of admitted patients eligible and recruited and by questionnaire-response rates at baseline and follow up. Reasons for non-recruitment and non-completion of questionnaires were sought and recorded. RESULTS: There were 276 admissions, of whom 235 (85.1 %) were eligible. Reasons for ineligibility were the following: age under 18 years old (n = 5, 1.8 %), non-surgical presenting complaint (n = 6, 2.2 %) and clinical instability (n = 30, 10.9 %). One hundred and sixty-six patients (70.6 %) were recruited (98 female, 59.0 %); median age 53, range 19-100). Common reasons for non-recruitment included patients being discharged home before approached by researchers (n = 29, 12.3 %) or declining participation because they felt unwell (n = 15, 6.4 %). The most common reason for admission to the hospital was abdominal pain (n = 120, 72.3 % recruited patients), of whom 50 (30.1 %) required operative intervention. Baseline PRO data was obtained from 153 patients (93.3 %), and 74 (48.4 %) returned follow-up questionnaires. CONCLUSIONS: Collection of baseline PRO data amongst unplanned admissions in general surgery is feasible. Methods for optimising retention and follow up are needed.

Health-related quality-of-life assessment in GI cancer randomized trials: improving the impact on clinical practice.

Despite increasing interest in assessing health-related quality of life (HRQoL) in randomized trials in gastrointestinal cancer, there remains uncertainty regarding the added value of this data to clinical decision-making. Reasons for this observation may relate to inadequacies in trial design and reporting, and difficulties in understanding and interpreting HRQoL data in a clinical context. It is essential to design trials to capture the relevant changes in HRQoL and for clinicians to be able to understand and communicate the results to patients. Even if HRQoL data are discussed routinely in clinical consultations, there are challenges in facilitating patients' understanding of such outcomes. A range of methods, including narrative descriptions and graphs, may represent the optimal option to discuss HRQoL data with patients in the context of shared decision-making. This review considers these issues in detail and future areas for applied HRQoL research.