The Tip and Torque adjustable bracket as a new concept in design.

OBJECTIVES: To test a new concept in bracket design-the tip and torque adjustable bracket (TTAB)-to identify its integral ability to change both tip and torque. MATERIALS AND METHODS: The newly designed TTAB underwent independent testing using the orthodontic measurement and simulation system. The TTAB incorporated Roth tip and torque prescription values, with the unique quality of the bracket to enhance or reduce the innate prescribed values of tip (by either +10° or -10°) and torque (by either +7.5° or -7.5°). The TTAB was tested using both the incorporated standard Roth prescription on the rate of canine retraction (sliding mechanics), using 0.018-inch stainless-steel (SS) arch wire, and with alteration of tip values (-10° and +10°). Similarly, frictional measurements and torque evaluations using 0.019 × 0.025-inch SS arch wire were undertaken with the standard prescription and altered torque (+7.5° and -7.5°). In addition, a number of control investigations were performed. Differences were analyzed using analysis of variance. RESULTS: The rate of observed tooth movement for the TTAB with its prescribed baseline values was comparable to that of the control brackets. Importantly, the alteration of TTAB tip to -10° and +10° significantly (P < .001) increased and reduced, respectively, the rates of canine retraction. In the alteration of torque, at +7.5° and -7.5°, the bracket delivered a moment of +9.3 (2.8) Nmm and -11.9 (3.8) Nmm, respectively, to the lateral incisor (P < .001). CONCLUSIONS: This in vitro study demonstrates a new concept in preadjusted edgewise bracket design, offering adjustable tip and torque, with the potential for expanded clinical scope.

Understanding the Influences of COPD Patient's Capability on the Uptake of Pulmonary Rehabilitation in the UK Through an Inclusive Design Approach.

Background: Pulmonary rehabilitation (PR) is recommended for patients with COPD to improve their symptoms and quality of life. However, in the UK, only one in ten of those who need PR receive it and this might be inaccessible to people with disabilities. This study aims to inform improvements to PR service by identifying barriers to the uptake of PR in the COPD care journey in relation to patients' capabilities that can affect their access to PR. Methods: An Inclusive Design approach with mixed methods was undertaken. Firstly, patients and healthcare professionals were interviewed to gather insight into their experiences of COPD care and map patients' care journey. Secondly, an Exclusion Calculator was used to estimate service demand on patients' capability and the proportion of population excluded from the service. Thirdly, a framework analysis was applied to guide data analysis to identify the challenges of accessing PR. Finally, proposed recommendations were refined with patients and healthcare professionals. Results: The overall capability-related exclusion number was very high (62.5%), and exclusion caused by limited mobility was the highest (50%) among the interviewees and even higher based on the population database. This suggests the importance of considering COPD patients' capability-related needs to improve their access to care. Capability-related challenges for patients accessing PR such as poor mobility to transport and low vision impairing ability to read inhaler instructions were identified, as well as non-capability-related challenges such as patients' perception about COPD and inability to access proper information. Recommendations were proposed to help patients to self-manage their COPD and access to PR. Conclusion: Lack of attention to COPD patients' capability level in the delivery of PR may affect its uptake. Considering the capability-related needs of COPD patients and providing patients with reassurance, information, and support on their care journey could improve the uptake of PR.

Systems approach to health service design, delivery and improvement: a systematic review and meta-analysis.

OBJECTIVES: To systematically review the evidence base for a systems approach to healthcare design, delivery or improvement. DESIGN: Systematic review with meta-analyses. METHODS: Included were studies in any patients, in any healthcare setting where a systems approach was compared with usual care which reported quantitative results for any outcomes for both groups. We searched Medline, Embase, HMIC, Health Business Elite, Web of Science, Scopus, PsycINFO and CINAHL from inception to 28 May 2019 for relevant studies. These were screened, and data extracted independently and in duplicate. Study outcomes were stratified by study design and whether they reported patient and/or service outcomes. Meta-analysis was conducted with Revman software V.5.3 using ORs-heterogeneity was assessed using I2 statistics. RESULTS: Of 11 405 records 35 studies were included, of which 28 (80%) were before-and-after design only, five were both before-and-after and concurrent design, and two were randomised controlled trials (RCTs). There was heterogeneity of interventions and wide variation in reported outcome types. Almost all results showed health improvement where systems approaches were used. Study quality varied widely. Exploratory meta-analysis of these suggested favourable effects on both patient outcomes (n=14, OR=0.52 (95% CI 0.38 to 0.71) I2=91%), and service outcomes (n=18, OR=0.40 (95% CI 0.31 to 0.52) I2=97%). CONCLUSIONS: This study suggests that a systems approaches to healthcare design and delivery results in a statistically significant improvement to both patient and service outcomes. However, better quality studies, particularly RCTs are needed.PROSPERO registration numberCRD42017065920.

Improving people's access to community-based back pain treatment through an inclusive design approach.

Back pain is a very common health problem and affects people across the world. This study applies an Inclusive Design approach to a community-based back pain service to understand the challenges, in relation to patients' capabilities, that can affect their access to the service. It consisted of three steps: i) online surveys and interviews with physiotherapists and collected patients' personal online care stories to gather insight into their experiences within the back pain care journeys; ii) estimated services' demands made on patients when they access the service and identified the related challenges and iii) proposed recommendations that could address the challenges for patients to access the service. The study suggests an Inclusive Design approach could help identify capability-related challenges such as vision and memory which could affect people's access to back pain treatment. In addition, the application of the approach also uncovered some non-capability-related challenges.

Developing an intervention to increase REferral and uptake TO pulmonary REhabilitation in primary care in patients with chronic obstructive pulmonary disease (the REsTORE study): mixed methods study protocol.

INTRODUCTION: Chronic obstructive pulmonary disease (COPD) is a progressive lung disease associated with breathlessness, inability to exercise, frequent infections, hospitalisation and reduced quality of life. Pulmonary rehabilitation (PR), providing supervised exercise and education, is an effective and cost-effective treatment for COPD but is significantly underused. Interventions to improve referral and uptake have been tested and some positive results reported. However, interventions are diverse and no clear recommendations for practice can be made. This study aims to understand the challenges to referral and uptake in primary care, where most referrals originate, and to develop a flexible toolkit of resources to support referral and uptake to PR in primary care in the UK. METHODS AND ANALYSIS: This is a mixed methods study informed by normalisation process theory and burden of treatment theory. In the first phase, general practitioners, practice nurses and PR providers will be invited to complete an online survey to inform a broad exploration of the topic areas. In phase 2 interviews and focus groups will be conducted with patients, healthcare professionals (HCP) in primary care, PR providers and commissioners to gain an in-depth understanding of the issues and needs. Toolkit development in phase 3 will draw together the learning from phases 1 and 2 and employ an iterative development process to build the toolkit jointly with patients and HCPs. It will be tested in primary care for usability and acceptability. ETHICS AND DISSEMINATION: The study has ethical and Health Research Authority approval (Research Ethics Committee reference number 17/EE/0136). It is registered with the International Standard Registered Clinical/Social Study Number (ISRCTN) registry (trial ID: ISRCTN20669629, assignment date 20 March 2018, trial start date 1 April 2016). Dissemination will be aimed at patients, carers/families, service providers, commissioners and national interest groups. Methods will include conferences, presentations, academic publications and plain English reports and will be supported by the British Lung Foundation. TRIAL REGISTRATION NUMBER: ISRCTN20669629 ; Pre-results.

Understanding influences on the uptake of pulmonary rehabilitation in the East of England: an Inclusive Design/mixed-methods study protocol.

INTRODUCTION: 1.2 million people in the UK have chronic obstructive pulmonary disease (COPD) that causes breathlessness, difficulty with daily activities, infections and hospitalisation. Pulmonary rehabilitation (PR), a programme of supervised exercise and education, is recommended for patients with COPD. However, only 1 in 10 of those who need it receive PR. Also, the UK National COPD Audit Programme concluded that the COPD treatment might not be accessible to people with disabilities. This paper applies an Inclusive Design approach to community-based PR service provisions. It aims to inform improvements to the PR service by identifying barriers to the uptake of PR in the COPD care journey in relation to patients' capabilities that can affect their access to PR. METHODS AND ANALYSIS: The protocol includes four steps. Step 1 will involve interviews with healthcare professionals and patients to gather insight into their experiences and produce a hierarchical task analysis of the COPD care journeys. Step 2 will estimate the service exclusion: the demand of every task on patients' capabilities will be rated by predefined scales, and the proportion of the population excluded from the service will be estimated by an exclusion calculator. Step 3 will identify the challenges of the PR service; a framework analysis will guide the data analysis of the interviews and care journey. Step 4 will propose recommendations to help patients manage their COPD care informed by the challenges identified in step 3 and refine recommendations through interviews and focus groups. ETHICS AND DISSEMINATION: The Cambridge Central Research Ethics Committee gave the study protocol a positive ethical opinion (17/EE/0136). Study results will be disseminated through peer-reviewed journals, conferences and the British Lung Foundation networks. They will also be fed into a Research for Patient Benefit project on increasing the referral and uptake of PR.

Stakeholder challenges in purchasing medical devices for patient safety.

OBJECTIVE: This study identifies the stakeholders who have a role in medical device purchasing within the wider system of health-care delivery and reports on their particular challenges to promote patient safety during purchasing decisions. METHODS: Data was collected through observational work, participatory workshops, and semi-structured qualitative interviews, which were analyzed and coded. The study takes a systems-based and engineering design approach to the study. Five hospitals took part in this study, and the participants included maintenance, training, clinical end-users, finance, and risk departments. RESULTS: The main stakeholders for purchasing were identified to be staff from clinical engineering (Maintenance), device users (Clinical), device trainers (Training), and clinical governance for analyzing incidents involving devices (Risk). These stakeholders display varied characteristics in terms of interpretation of their own roles, competencies for selecting devices, awareness and use of resources for purchasing devices, and attitudes toward the purchasing process. The role of "clinical engineering" is seen by these stakeholders to be critical in mediating between training, technical, and financial stakeholders but not always recognized in practice. CONCLUSIONS: The findings show that many device purchasing decisions are tackled in isolation, which is not optimal for decisions requiring knowledge that is currently distributed among different people within different departments. The challenges expressed relate to the wider system of care and equipment management, calling for a more systemic view of purchasing for medical devices.