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.

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.

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.

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.

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.

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.

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.

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.