The financial and quality of life impact of urgent dental presentations: A cross-sectional study.

AIM: This study aimed to: (i) calculate personal financial costs associated with urgent dental attendance; and (ii) investigate the pain-related disability and quality of life impact of dental conditions which result in urgent dental attendance. METHODOLOGY: Data were collected from those presenting with urgent dental conditions to an out-of-hours dental service, a dental emergency clinic (DEC) and five primary care general dental practices across North-East England. A pre-operative questionnaire explored the impact of urgent dental conditions on oral health-related quality of life (OHRQoL) using Oral Health Impact Profile-14 (OHIP-14) and a modified Graded Chronic Pain Scale (GCPS). OHIP-14 yields a maximum score of 56, with a higher score indicating a lower OHRQoL. Personal financial costs were summed to provide a total. These included travel, appointment fees, childcare costs, medication use and time away from work. Data were analysed using one-way anova and multivariable modelling. RESULTS: In total, 714 participants were recruited. The mean OHIP-14 score was 25.73; 95% CI [24.67, 26.79], GCPS CPI was 71.69; 95% CI [70.09, 73.28] and GCPS interference was 49.56; 95% CI [47.24, 51.87]. Symptomatic irreversible pulpitis was the most frequently managed dental emergency and was associated with the highest mean OHIP-14 score (31.67; 95% CI [30.20, 33.15]). The mean personal financial cost of urgent dental care (UDC) was £85.81; 95% CI [73.29, 98.33]. Differences in travel time (F[2, 691] = 10.24, p < .001), transport costs (F[2, 698] = 4.92, p = .004), and appointment time (F[2, 74] = 9.40, p < .001) were significant between patients attending an out-of-hours dental service, DEC and dental practices for emergency care, with a DEC being associated with the highest costs and dental practices the lowest. CONCLUSIONS: Diseases of the pulp and associated periapical disease were the most common reason for patients to present for UDC and were the most impactful in terms of OHRQoL and pain in the present sample. Personal financial costs are significant from urgent dental conditions, with centralized services increasing the burden to patients of attending appointments.

Photodynamic versus white-light-guided resection of first-diagnosis non-muscle-invasive bladder cancer: PHOTO RCT.

BACKGROUND: Around 7500 people are diagnosed with non-muscle-invasive bladder cancer in the UK annually. Recurrence following transurethral resection of bladder tumour is common, and the intensive monitoring schedule required after initial treatment has associated costs for patients and the NHS. In photodynamic diagnosis, before transurethral resection of bladder tumour, a photosensitiser that is preferentially absorbed by tumour cells is instilled intravesically. Transurethral resection of bladder tumour is then conducted under blue light, causing the photosensitiser to fluoresce. Photodynamic diagnosis-guided transurethral resection of bladder tumour offers better diagnostic accuracy than standard white-light-guided transurethral resection of bladder tumour, potentially reducing the chance of subsequent recurrence. OBJECTIVE: The objective was to assess the clinical effectiveness and cost-effectiveness of photodynamic diagnosis-guided transurethral resection of bladder tumour. DESIGN: This was a multicentre, pragmatic, open-label, parallel-group, non-masked, superiority randomised controlled trial. Allocation was by remote web-based service, using a 1 : 1 ratio and a minimisation algorithm balanced by centre and sex. SETTING: The setting was 22 NHS hospitals. PARTICIPANTS: Patients aged ≥ 16 years with a suspected first diagnosis of high-risk non-muscle-invasive bladder cancer, no contraindications to photodynamic diagnosis and written informed consent were eligible. INTERVENTIONS: Photodynamic diagnosis-guided transurethral resection of bladder tumour and standard white-light cystoscopy transurethral resection of bladder tumour. MAIN OUTCOME MEASURES: The primary clinical outcome measure was the time to recurrence from the date of randomisation to the date of pathologically proven first recurrence (or intercurrent bladder cancer death). The primary health economic outcome was the incremental cost per quality-adjusted life-year gained at 3 years. RESULTS: We enrolled 538 participants from 22 UK hospitals between 11 November 2014 and 6 February 2018. Of these, 269 were allocated to photodynamic diagnosis and 269 were allocated to white light. A total of 112 participants were excluded from the analysis because of ineligibility (n = 5), lack of non-muscle-invasive bladder cancer diagnosis following transurethral resection of bladder tumour (n = 89) or early cystectomy (n = 18). In total, 209 photodynamic diagnosis and 217 white-light participants were included in the clinical end-point analysis population. All randomised participants were included in the cost-effectiveness analysis. Over a median follow-up period of 21 months for the photodynamic diagnosis group and 22 months for the white-light group, there were 86 recurrences (3-year recurrence-free survival rate 57.8%, 95% confidence interval 50.7% to 64.2%) in the photodynamic diagnosis group and 84 recurrences (3-year recurrence-free survival rate 61.6%, 95% confidence interval 54.7% to 67.8%) in the white-light group (hazard ratio 0.94, 95% confidence interval 0.69 to 1.28; p = 0.70). Adverse event frequency was low and similar in both groups [12 (5.7%) in the photodynamic diagnosis group vs. 12 (5.5%) in the white-light group]. At 3 years, the total cost was £12,881 for photodynamic diagnosis-guided transurethral resection of bladder tumour and £12,005 for white light. There was no evidence of differences in the use of health services or total cost at 3 years. At 3 years, the quality-adjusted life-years gain was 2.094 in the photodynamic diagnosis transurethral resection of bladder tumour group and 2.087 in the white light group. The probability that photodynamic diagnosis-guided transurethral resection of bladder tumour was cost-effective was never > 30% over the range of society's cost-effectiveness thresholds. LIMITATIONS: Fewer patients than anticipated were correctly diagnosed with intermediate- to high-risk non-muscle-invasive bladder cancer before transurethral resection of bladder tumour and the ratio of intermediate- to high-risk non-muscle-invasive bladder cancer was higher than expected, reducing the number of observed recurrences and the statistical power. CONCLUSIONS: Photodynamic diagnosis-guided transurethral resection of bladder tumour did not reduce recurrences, nor was it likely to be cost-effective compared with white light at 3 years. Photodynamic diagnosis-guided transurethral resection of bladder tumour is not supported in the management of primary intermediate- to high-risk non-muscle-invasive bladder cancer. FUTURE WORK: Further work should include the modelling of appropriate surveillance schedules and exploring predictive and prognostic biomarkers. TRIAL REGISTRATION: This trial is registered as ISRCTN84013636. FUNDING: This project was funded by the National Institute for Health and Care Research ( NIHR ) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 40. See the NIHR Journals Library website for further project information.

Around 7500 people are diagnosed with early-stage bladder cancer in the UK each year. Early bladder cancer is contained within the bladder and has not yet invaded the bladder's muscle wall or spread elsewhere in the body. The cancer will return (recur) in around half of people after initial treatment and they have to attend hospital for regular check-ups, with costs to both them and the NHS. The first step in treating early bladder cancer is surgery to remove the tumour. This surgery is normally performed under white light. Photodynamic diagnosis is a new technique in which a liquid is put into the patient's bladder before surgery and a blue light is used during the operation. This causes the bladder cancer to fluoresce so that it can be seen more easily by the surgeon. The Photodynamic versus white-light-guided resection of first diagnosis non-muscle-invasive bladder cancer ( PHOTO ) trial aimed to find out whether or not using photodynamic diagnosis at initial surgery would reduce how often the cancer recurred and whether or not this could reduce the cost of treating early bladder cancer. A total of 538 people with early bladder cancer who had a medium to high chance of their cancer returning after treatment were enrolled in the PHOTO trial. They were included in one of two treatment groups, at random: 269 had photodynamic surgery and 269 had standard white-light surgery. People in both groups were monitored regularly for any recurrences, with further treatment as appropriate. After 3 years, 4 out of 10 people in each group had a recurrence of their bladder cancer. We found no difference between the treatment groups in the number of people with recurrences. We found no evidence of a benefit to patients, and the total costs of photodynamic surgery were higher than those of standard white light. We therefore recommend that it is no longer used in the treatment of this group of patients.

Rationing care by frailty during the COVID-19 pandemic.

The coronavirus disease 2019 (COVID-19) pandemic is disproportionately affecting older people and those with underlying comorbidities. Guidelines are needed to help clinicians make decisions regarding appropriate use of limited NHS critical care resources. In response to the pandemic, the National Institute for Health and Care Excellence published guidance that employs the Clinical Frailty Scale (CFS) in a decision-making flowchart to assist clinicians in assessing older individuals' suitability for critical care. This commentary raises some important limitations to this use of the CFS and cautions against the potential for unintended impacts. The COVID-19 pandemic has allowed the widespread implementation of the CFS with limited training or expert oversight. The CFS is primarily being used to assess older individuals' risk of adverse outcome in critical care, and to ration access to care on this basis. While some form of resource allocation strategy is necessary for emergencies, the implementation of this guideline in the absence of significant pressure on resources may reduce the likelihood of older people with frailty, who wish to be considered for critical care, being appropriately considered, and has the potential to reinforce the socio-economic gradient in health. Our incomplete understanding of this novel disease means that there is a need for research investigating the short-term predictive abilities of the CFS on critical care outcomes in COVID-19. Additionally, a review of the impact of stratifying older people by CFS score as a rationing strategy is necessary in order to assess its acceptability to older people as well as its potential for disparate impacts.

Challenges in the clinical implementation of a biopsychosocial model for assessment and management of orofacial pain.

Distress, suffering and care-seeking behaviour are characteristics of pain-related disease and illness. Pain that transitions from an acute to a chronic phase carries with it the potential of further effects: these include a worsening of the disease or illness; high-impact chronic pain; and substantial personal, societal and economic burden. The biopsychosocial model directly addresses these multiple processes, yet clinical frameworks supporting this model are not universally implemented. This paper explores barriers to clinical implementation of a full biopsychosocial framework for temporomandibular disorders (TMD) and other oro-facial pain (OFP) conditions. In June 2016, INfORM invited OFP researchers to a workshop designed to optimise the DC/TMD Axis-II. Workshop groups identified five sources of implementation barriers: (1) cultures and societies, (2) levels-of-care settings, (3) health services, (4) cross-cultural validity of self-report instruments and (5) provider and patient health literacy. Three core problems emerged: (A) mental health aspects are seldom fully considered, thus impairing the recognition of illness, (B) training in use of validated multi-axial assessment protocols is under-rated and insufficiently used, and (C) clinical assessment often fails to recognise that sensory and emotional dimensions are fundamental aspects of pain. To improve patient care, these barriers and problems require action. Most importantly, TMD/OFP educators and researchers need to coordinate globally and (i) be educated in the biopsychosocial model, (ii) implement evidence-based biopsychosocial guidelines for assessment and management of OFP conditions at their institutions, (iii) incorporate this model in undergraduate and postgraduate dental curricula and (iv) be responsive to stakeholders, including regulatory authorities and practitioners.

Conducting a Time Trade-Off Study Alongside a Clinical Trial: A Case Study and Recommendations.

Time trade-off (TTO) is an established method in health economics to elicit and value individuals' preferences for different health states. These preferences are expressed in the form of health-state utilities that are typically used to measure health-related quality of life and calculate quality-adjusted life-years in an economic evaluation. The TTO approach to directly elicit health-state utilities is particularly valuable when generic instruments (e.g. EQ-5D) may not fully capture changes in utility in a clinical trial. However, there is limited guidance on how a TTO study should be conducted alongside a clinical trial despite it being a valuable tool. We present an account of the design and development of a TTO study within a clinical trial as a case study. We describe the development of materials needed for the TTO interviews, the piloting of the TTO materials and interview process, and recommendations for future TTO studies. This paper provides a practical guide and reference for future applications of the TTO method alongside a clinical trial.

Developing Effective and Efficient care pathways in chronic Pain: DEEP study protocol.

BACKGROUND: Pain affecting the face or mouth and lasting longer than three months ("chronic orofacial pain", COFP) is relatively common in the UK. This study aims to describe and model current care pathways for COFP patients, identify areas where current pathways could be modified, and model whether these changes would improve outcomes for patients and use resources more efficiently. METHODS/DESIGN: The study takes a prospective operations research approach. A cohort of primary and secondary care COFP patients (n = 240) will be recruited at differing stages of their care in order to follow and analyse their journey through care. The cohort will be followed for two years with data collected at baseline 6, 12, 18, and 24 months on: 1) experiences of the care pathway and its impacts; 2) quality of life; 3) pain; 4) use of health services and costs incurred; 5) illness perceptions. Qualitative in-depth interviews will be used to collect data on patient experiences from a purposive sub-sample of the total cohort (n = 30) at baseline, 12 and 24 months. Four separate appraisal groups (public, patient, clincian, service manager/commissioning) will then be given data from the pathway analysis and asked to determine their priority areas for change. The proposals from appraisal groups will inform an economic modelling exercise. Findings from the economic modelling will be presented as incremental costs, Quality Adjusted Life Years (QALYs), and the incremental cost per QALY gained. At the end of the modelling a series of recommendations for service change will be available for implementation or further trial if necessary. DISCUSSION: The recent white paper on health and the report from the NHS Forum identified chronic conditions as priority areas and whilst technology can improve outcomes, so can simple, appropriate and well-defined clinical care pathways. Understanding the opportunity cost related to care pathways benefits the wider NHS. This research develops a method to help design efficient systems built around one condition (COFP), but the principles should be applicable to a wide range of other chronic and long-term conditions.