Joyce Craig

Epithelium-Off Photochemical Corneal Collagen Cross-Linkage Using Riboflavin and Ultraviolet A for Keratoconus and Keratectasia: A Systematic Review and Meta-Analysis

This report presents the results of a systematic review and meta-analyses of studies on epithelium-off photochemical corneal collagen cross-linkage for the management of keratoconus and secondary ectasia. The literature search identified 3,400 records of which 49 were considered for inclusion in the meta-analyses. Eight papers reported 4 unique randomized controlled trials, 29 studies were prospective, and 12 were retrospective studies. The majority of the studies (39/49) were graded as very low quality evidence. Twenty-six studies described adverse events and were included in the safety analysis. Meta-analyses are presented for changes in four outcomes: visual acuity, topography, refraction and astigmatism, and central corneal thickness. Statistically significant improvements were found in all efficacy outcomes at 12 months after the operation. Common side effects were pain, corneal edema, and corneal haze, which resolved usually within a few days after the procedure. The remaining uncertainty is duration of benefit to establish the procedures potential benefit in avoiding or delaying disease progression and possibly reducing the need for corneal transplantation.

Nutrition economic evaluation of a probiotic in the prevention of antibiotic-associated diarrhea.

Introduction: Antibiotic-associated diarrhea (AAD) is common and frequently more severe in hospitalized elderly adults. It can lead to increased use of healthcare resources. We estimated the cost-effectiveness of a fermented milk (FM) with probiotic in preventing AAD and in particular Clostridium difficile-associated diarrhea (CDAD). Methods: Clinical effectiveness data and cost information were incorporated in a model to estimate the cost impact of administering a FM containing the probiotic Lactobacillus paracasei ssp paracasei CNCM I-1518 in a hospital setting. Preventing AAD by the consumption of the probiotic was compared to no preventive strategy. Results: The probiotic intervention to prevent AAD generated estimated mean cost savings of £339 per hospitalized patient over the age of 65 years and treated with antibiotics, compared to no preventive probiotic. Estimated cost savings were sensitive to variation in the incidence of AAD, and to the proportion of patients who develop non-severe/severe AAD. However, probiotics remained cost saving in all sensitivity analyses. Conclusion: Use of the fermented dairy drink containing the probiotic L. paracasei CNCM I-1518 to prevent AAD in older hospitalized patients treated with antibiotics could lead to substantial cost savings.

The high cost to health and social care of managing falls in older adults living in the community in Scotland

Background and aims Estimate costs for health and social care services in managing older people in the community who fall. Method and results Analyses of predominantly national databases using cost of illness methodologies. In Scotland, 294,000 (34%) of people over 65 years and living in the community fall at least once a year. Of these 20%, almost 60,000 people contacted a medical service for assistance. There were almost 30,000 attendances at GP practices, over 36,100 calls to the Scottish Ambulance Service and 46,816 people presenting at A&E, with 16,549 admitted, 30% with a hip fracture. Mortality was high, 7% during the hospital stay, rising to over 12% at 1 year. Over 20% of patients were unable to return to their homes. Associated costs were over £470 million, with 60% incurred by social services, mainly providing long-term care. Cost per person falling was over £1720, rising to over £8600 for those seeking medical assistance. A hip fracture admission cost £39,490, compared with £21,960 for other falls-related admissions. Conclusions Transparent, robust cost information demonstrates the substantial burden of falls for health and social care services and should be a driver for implementing evidence-based interventions to reduce falls.

A review of the economic tools for assessing new medical devices.

Whereas the economic evaluation of pharmaceuticals is an established practice within international health technology assessment (HTA) and is often produced with the support of comprehensive methodological guidance, the equivalent procedure for medical devices is less developed. Medical devices, including diagnostic products, are a rapidly growing market in healthcare, with over 10,000 medical technology patent applications filed in Europe in 2012—nearly double the number filed for pharmaceuticals. This increase in the market place, in combination with the limited, or constricting, budgets that healthcare decision makers face, has led to a greater level of examination with respect to the economic evaluation of medical devices. However, methodological questions that arise due to the unique characteristics of medical devices have yet to be addressed fully. This review of journal publications and HTA guidance identified these characteristics and the challenges they may subsequently pose from an economic evaluation perspective. These unique features of devices can be grouped into four categories: (1) data quality issues; (2) learning curve; (3) measuring long-term outcomes from diagnostic devices; and (4) wider impact from organisational change. We review the current evaluation toolbox available to researchers and explore potential future approaches to improve the economic evaluation of medical devices.

An evaluation of the impact of the key information summary on GPs and out-of-hours clinicians in NHS Scotland:

Background and aims Key information summary is one of the first national shared electronic patient records enabling GPs to share clinical information with unscheduled care providers, including out-of-hours. Implemented during 2013, over 90,000 patient records have been created. This evaluation identified the impact of key information summary on healthcare services. Methods Evidence was collected using online questionnaires and structured telephone interviews. Opinions providing a numerical estimate of value were analysed using statistical methods, while qualitative responses were synthesised using thematic analysis. Results The vast majority of respondents from 441 GP practices and 33 out-of-hours clinicians show that key information summary enhances patient safety, improves clinical management, reduces hospital admissions, empowers clinicians, aids communication across services and enables decisions to be responsive to patients’ wishes. Conclusions Patients willingly consent to share data with unscheduled care clinicians. Patients benefitting include those with palliative, complex or multiple conditions, at high risk of using emergency services. Out-of-hours clinicians would welcome more key information summaries, all well-completed and including social care information. Improvements include software enhancements and wider sharing of information with all unscheduled care services.

Warfarin monitoring economic evaluation of point of care self-monitoring compared to clinic settings.

Abstract Objective: To determine the cost-effectiveness of home-based point-of-care self-monitoring compared to clinic-based care for patients managed on long-term warfarin medication. Current evidence is inconsistent; results should reduce uncertainty and inform service delivery. Methods: A Markov model compared self-testing and self-management, using point-of-care devices to usual care in patients with atrial fibrillation and mechanical heart valves. The primary clinical end-points were stroke and mortality avoided; costs and utilities were associated with these events. The costs of warfarin monitoring were included in the model. Results: Over 10 years, self-monitoring saved £1187 per person compared to usual care. Patients who self-monitored had notably fewer strokes and deaths. The results were sensitive to life-years gained and cost of the device. If the NHS purchased the device, financial break-even was achieved at the end of the second year; if the patient bought the device the NHS saved money every year. If 10% of the current 950,000 patients switched to point-of-care devices for 10 years, the NHS could save over £112million. Limitations: Clinical studies had a relatively short duration and only data on composite end-points were reported. Conclusions: With training, self-testing and self-management are safe, reliable, and cost-effective for a sizable proportion of patients receiving long-term warfarin. Compared to clinic-based services, self-monitoring offers the NHS the potential to make cost savings and release bed-days by reducing the number of strokes experienced by these high-risk patients.

Collaborating with front-line healthcare professionals: the clinical and cost effectiveness of a theory based approach to the implementation of a national guideline

BackgroundClinical guidelines are an integral part of healthcare. Whilst much progress has been made in ensuring that guidelines are well developed and disseminated, the gap between routine clinical practice and current guidelines often remains wide. A key reason for this gap is that implementation of guidelines typically requires a change in the behaviour of healthcare professionals – but the behaviour change component is often overlooked. We adopted the Theoretical Domains Framework Implementation (TDFI) approach for supporting behaviour change required for the uptake of a national patient safety guideline to reduce the risk of feeding through misplaced nasogastric tubes.MethodsThe TDFI approach was used in a pre-post study in three NHS hospitals with a fourth acting as a control (with usual care and no TDFI). The target behavior identified for change was to increase the use of pH testing as the first line method for checking the position of a nasogastric tube. Repeat audits were undertaken in each hospital following intervention implementation. We used Zou’s modified Poisson regression approach with robust standard errors to estimate risk ratios for the use of pH testing. The projected return on investment (ROI) was also calculated.ResultsFollowing intervention implementation, the use of pH first line increased significantly across intervention hospitals [risk ratio (95% CI) ranged from 3.1 (1.14 to8.43) p < .05, to 8.14 (3.06 to21.67) p < .001] compared to the control hospital, which remained unchanged [risk ratio (CI) = .77 (.47-1.26) p = .296]. The estimated savings and costs in the first year were £2.56 million and £1.41 respectively, giving an ROI of 82%, and this was projected to increase to 270% over five years.ConclusionThe TDFI approach improved the uptake of a patient safety guideline across three hospitals. The TDFI approach is clinically and cost effective in comparison to the usual practice.

Spectra Optia(®) for Automated Red Blood Cell Exchange in Patients with Sickle Cell Disease: A NICE Medical Technology Guidance.

The Spectra Optia® automated apheresis system, indicated for red blood cell exchange in people with sickle cell disease, underwent evaluation by the National Institute for Health and Care Excellence, which uses its Medical Technologies Advisory Committee to make recommendations. The company (Terumo Medical Corporation) produced a submission making a case for adoption of its technology, which was critiqued by the Newcastle and York external assessment centre. Thirty retrospective observational studies were identified in their clinical submission. The external assessment centre considered these were of low methodological and reporting quality. Most were single-armed studies, with only six studies providing comparative data. The available data showed that, compared with manual red blood cell exchange, Spectra Optia reduces the frequency of exchange procedures as well as their duration, but increases the requirement for donor blood. However, other clinical and patient benefits were equivocal because of an absence of robust clinical evidence. The company provided a de novo model to support the economic proposition of the technology, and reported that in most scenarios Spectra Optia was cost saving, primarily through reduced requirement of chelation therapy to manage iron overload. The external assessment centre considered that although the cost-saving potential of Spectra Optia was plausible, the model and its clinical inputs were not sufficiently robust to demonstrate this. However, taking the evidence together with expert and patient advice, the Medical Technologies Advisory Committee considered Spectra Optia was likely to save costs, provide important patient benefits, and reduce inequality, and gave the technology a positive recommendation in Medical Technology Guidance 28.

Use of Expert Judgement Across NICE Guidance-Making Programmes: A Review of Current Processes and Suitability of Existing Tools to Support the Use of Expert Elicitation

ObjectivesThis study aimed to review current use of experts within National Institute for Health and Care Excellence (NICE) guidance-making programmes, identify improvements in use of expert judgement, and to assess tools and protocols to support the elicitation of information from experts for use by NICE.MethodsThe study comprised a review of NICE process guides; semi-structured interviews with individuals representing each NICE guidance-making programme and a comparison of the suitability of currently available tools and protocols for expert elicitation to the requirements of NICE programmes.ResultsInformation elicited from experts and the way in which it is used varies across NICE guidance-making programmes. Experts’ involvement can be as intensive as being a member of a committee and thus having direct influence on recommendations or limited one-off consultations on specific parameters. We identified 16 tools for expert elicitation that were potentially relevant. None fully met the requirements of NICE, although an existing tool could be potentially adapted. Ongoing research to develop a reference protocol for expert elicitation in healthcare decision making may be of use in future.ConclusionsNICE uses expert judgement across all its guidance-making programmes, but its uses vary considerably. There is no currently available tool for expert elicitation suitable for use by NICE. However, adaptation of an existing tool or ongoing research in the area could address this in the future.

The XprESS Multi-Sinus Dilation System for the Treatment of Chronic Sinusitis: A NICE Medical Technology Guidance

The XprESS multi-sinus dilation system (XprESS) is a minimally invasive alternative to functional endoscopic sinus surgery (FESS) used in the treatment of people with chronic or recurrent acute sinusitis refractory to medical treatment. The manufacturer of XprESS, Entellus Medical, claims the technology is as effective as FESS in improving quality of life and is associated with quicker recovery times and reduced costs. The Medical Technologies Advisory Committee (MTAC) at the National Institute for Health and Care Excellence (NICE) selected XprESS for evaluation. Nine trials published in 13 papers were correctly identified by the company as relevant to the decision problem, including one randomised controlled trial (REMODEL study). From this evidence, the company concluded that XprESS is as beneficial as FESS for a range of clinical endpoints. The External Assessment Centre (EAC) agreed with the company’s conclusion in a subgroup of patients, but judged that the evidence did not generalise to patients within the NHS fully. The company constructed a de novo costing model. XprESS generated cost-savings of £1302 per patient compared with FESS. The EAC critiqued and updated the model’s inputs, with differences in results driven by changes in assumptions on procedure duration, length of hospital stay and the proportion of procedures undertaken in an outpatient setting under local anaesthetic. Although cost-incurring in the base case, XprESS generated cost savings under certain scenarios. The MTAC reviewed the evidence and supported the case for adoption, issuing positive draft recommendations. After public consultation NICE published this as Medical Technologies Guidance 30.