Episcissors-60 for Mediolateral Episiotomy: Evaluation of Clinical and Economic Evidence to Inform NICE Medical Technologies Guidance.

Obstetric anal sphincter injury (OASI) occurs in 2.9% of all vaginal births in the UK and can result in faecal incontinence. Where there is a clinical need for episiotomy, OASI can be minimised by accurate selection of the optimum angle of mediolateral episiotomy. Episcissors-60 are adapted surgical scissors incorporating a guide-limb to help achieve an accurate angle of mediolateral episiotomy. The ability of Episcissors-60 to reduce OASI by preventing inaccurate visual estimates of episiotomy angles was considered by the National Institute of Health and Care Excellence (NICE) as part of the Medical Technologies Evaluation Programme (MTEP). NICE concluded that Episcissors-60 shows promise for mediolateral episiotomy both in terms of clinical effectiveness and potential cost savings, but that there was not enough evidence to support routine adoption into the NHS at this time. NICE MTG47 recommends that key gaps in the evidence including patient-reported outcomes and the addition of Episcissors-60 to care bundles be addressed through research with specific focus on potential equality considerations.

The NICE Evidence Standards Framework for digital health and care technologies - Developing and maintaining an innovative evidence framework with global impact.

OBJECTIVE: In 2018, the UK National Institute for Health and Care Excellence (NICE), in partnership with Public Health England, NHS England, NHS Improvement and others, developed an evidence standards framework (ESF) for digital health and care technologies (DHTs). The ESF was designed to provide a standardised approach to guide developers and commissioners on the levels of evidence needed for the clinical and economic evaluation of DHTs by health and care systems. METHODS: The framework was developed using an agile and iterative methodology that included a literature review of existing initiatives and comparison of these against the requirements set by NHS England; iterative consultation with stakeholders through an expert working group and workshops; and questionnaire-based stakeholder input on a publicly available draft document. RESULTS: The evidence standards framework has been well-received and to date the ESF has been viewed online over 55,000 times and downloaded over 19,000 times. CONCLUSIONS: In April 2021 we published an update to the ESF. Here, we summarise the process through which the ESF was developed, reflect on its global impact to date, and describe NICE's ongoing work to maintain and improve the framework in the context for a fast moving, innovative field.

ASSESSING THE VALUE OF INNOVATIVE MEDICAL DEVICES AND DIAGNOSTICS: THE IMPORTANCE OF CLEAR AND RELEVANT CLAIMS OF BENEFIT.

OBJECTIVES: Large numbers of new medical devices and diagnostics are developed and health services need to identify which ones offer real advantages. The National Institute for Health and Care Excellence (NICE) has introduced a system for assessing technologies that are often notified by companies, based on claims made for their benefits to patients, the National Health Service, and the environment. METHODS: Detailed scrutiny of claims made for the benefits of products and the corresponding evidence, seeking associations between these and the selection of products for full evaluation to produce NICE guidance. RESULTS: Between 2009 and 2015 a NICE committee considered 169 technologies, of which it selected 74 (44 percent) for full evaluation, based on the claims of benefit and the evidence available. An average of 7.5 claims were made per technology; the total number did not influence selection but presence of studies supporting all the claims (p < .001) or any of the claims (p < .05) had a positive influence, as did claims for quicker patient recovery (p < .001). A greater number of studies to support the claims made selection more likely (p < .001), as did cohort studies (p < .05) and surveys (p < .05) but, unexpectedly, not randomized trials. The Medical Device Directive class had no influence. CONCLUSIONS: This study presents categories of claims that may be useful to those developing new products and to others engaged in health technology assessment. It illustrates the importance of relevant evidence and of having a clear vision of the place of new products in care pathways from an early stage.

Assessment of Range of Movement, Pain and Disability Following a Whiplash Injury.

BACKGROUND: Whiplash has been suggested to cause chronic symptoms and long term disability. This study was designed to assess long term function after whiplash injury. MATERIAL & METHODS: A random sample of patients in the outpatient clinic was interviewed, questionnaire completed and clinical examination performed. Assessment was made of passive cervical range of movement and Visual Analogue Scale pain scores. One hundred and sixty-four patients were divided into four different groups including patients with no whiplash injury but long-standing neck pain (Group A), previous symptomatic whiplash injury and long-standing neck pain (Group B), previous symptomatic whiplash injury and no neck symptoms (Group C), and a control group of patients with no history of whiplash injury or neck symptoms (Group D). RESULTS: Data was analyzed by performing an Independent samples t-test and ANOVA, with level of significance taken as p<0.05. Comparing the four groups using a one-way ANOVA showed a significant difference between the groups (p<0.001). There were significant differences when comparing mean ranges of movement between Group A and Group D, and between Group B and Group D. There was no significant difference between Group C and Group D. similar differences were also seen in the pain scores. CONCLUSION: We conclude that osteoarthritis in the cervical spine, and whiplash injury with chronic problems cause a significantly decreased cervical range of movement with a higher pain score. Patients with shorter duration of whiplash symptoms appear to do better in the long-term.

A NEW HEALTH TECHNOLOGY ASSESSMENT SYSTEM FOR DEVICES: THE FIRST FIVE YEARS.

OBJECTIVES: The aim of this study was to review 5 years of activity from a new system devised by the National Institute for Health and Care Excellence (NICE), for assessing medical devices and diagnostics aimed at identifying and speeding adoption of technologies with clinical and cost advantages, compared with current practice in the United Kingdom healthcare system. METHODS: All eligible notified technologies were classified using the Food and Drug Administration and Global Medical Device Nomenclature nomenclatures. Decisions about selecting technologies for full assessment to produce NICE recommendations were reviewed, along with the reasons given to companies for not selecting products. RESULTS: Between 2009 and 2014, 186 technologies were notified (46 percent therapeutic and 54 percent diagnostic). Thirty-nine were judged ineligible (no regulatory approval), and 147 were considered by an independent committee. Of these, eighty (54 percent) were not selected for full assessment, most commonly because of insufficient evidence (86 percent): there were uncertainties specifically about benefits to the health service (54 percent), to patients (39 percent), and about cost (24 percent). The remaining 67 were selected and assessed for Medical Technology guidance (52 percent) (noninferior and/or lower cost consequences than current practice), for Diagnostics guidance (43 percent) or other NICE recommendations about adoption and use. Classifying technologies by two different systems showed no selection bias for any technology type or disease area. CONCLUSIONS: Identifying new or under-used devices and diagnostics with potential benefits and promoting their adoption is important to health services in the United Kingdom and worldwide. This new system offers a means of fostering both uptake and further research. Lack of research data on new products is a major obstacle to evaluation.

The validity, reliability, responsiveness, and bias of the Manchester-Modified Disability of the Arm, Shoulder, and Hand score in hand injuries.

The Manchester-Modified Disability of Arm, Shoulder and Hand questionnaire (M(2) DASH) was developed by the authors as a modification to the original DASH questionnaire. In this study, we assessed the validity, reliability, responsiveness, and bias of the M(2) DASH questionnaire for hand injuries using completed M(2) DASH, Patient Evaluation Measure, and Michigan Hand Outcome questionnaires from 40 patients. The M(2) DASH scores showed significant positive correlations with the Patient Evaluation Measure and Michigan Hand Outcome scores suggesting validity. There was also no evidence of a statistical difference in the M(2) DASH scores when the condition had stabilized suggesting good test-retest reproducibility and reliability. The effect size and the standardized response mean for the M(2) DASH score were greater than those for the Patient Evaluation Measure and Michigan Hand Outcome scores establishing that the M(2) DASH is highly responsive. There was no gender, hand dominance, or dominant side injured bias for the M(2) DASH score. There was, however, a relatively weak association between age and the M(2) DASH score at presentation. We conclude that the M(2) DASH questionnaire is a robust region-specific outcome measure. It is a valid and responsive questionnaire with test-retest reliability proven for hand injuries in this study. Gender, handedness, and side injured did not cause bias in the responses.

The 'M2 DASH'-Manchester-modified Disabilities of Arm Shoulder and Hand score.

The Disability of the Arm, Shoulder, and Hand (DASH) questionnaire was originally designed as a measure of disability in patients with disorders of the upper limb, but the DASH score is also affected by disability because of lower limb disorders. The aim of this study was to investigate the construct validity of the DASH questionnaire and to create a revised DASH questionnaire, the Manchester-modified or M2 DASH, with fewer questions that is more specific to the upper limb. Patients were asked to fill in the DASH questionnaire in a fracture clinic after ethical approval. This included 79 patients with upper limb injuries, 61 patients with lower limb injuries, and 52 control subjects. The mean DASH scores for the three groups varied significantly, and the lower limb group had a mean score of 16. The M2 DASH questionnaire was developed using questions more specific to the upper limb and included questions 1-4, 6, 13-17, 21-23, and 26-30 from the original questionnaire. The mean M2 DASH score for the lower limb group was 9 and, unlike the original DASH score, was not statistically different from the control group. The M2 DASH scores were then calculated for the upper limb group and a correlation study showed highly significant correlation between the original DASH scores and the M(2) DASH scores. Our study shows that the original DASH questionnaire is not specific for the upper limb. The M2 DASH questionnaire has the advantage of being more specific for the upper limb than the DASH questionnaire, and it correlates well with the original DASH questionnaire when looking at isolated upper limb injuries.

An analysis of hospital trauma care performance evaluation.

OBJECTIVE: The purpose of this article was to report on a study on the hospital trauma care performance evaluation based on a database of trauma events of participating UK and European hospitals. METHODS: Performance evaluation has become increasingly important in the quality assessment of health care in general and trauma care in particular. For many years, attempts to quantifying the performance of trauma care systems on a numerical scale have been developed and applied, including the use of Ws statistic. The Trauma Audit and Research Network collected and managed the data. We first investigated the currently used approaches in the evaluation of trauma care systems, and then proposed an alternative using a statistical control based approach for the comparison of different hospitals at one time. Different control charts and types of calculations were also proposed for the chronologic outcome chart, which plots the variation of trauma care within one hospital over time. RESULTS: New graphical methods for hospital trauma care performance evaluation based on statistical process plots were developed and tested on the project database. CONCLUSION: A control chart approach to the presentation of the outcome charts for hospital trauma care performance evaluation is presented in this article. The charts are more meaningful than the "caterpillar" plot traditionally used, and avoid the ranking of institutions into "league tables".