Development of a core outcome set for orthodontic trials using a mixed-methods approach: Protocol for a multicentre study

© 2017 The Author(s). Background: Orthodontic treatment is commonly undertaken in young people, with over 40% of children in the UK needing treatment and currently one third having treatment, at a cost to the National Health Service in England and Wales of £273 million each year. Most current research about orthodontic care does not consider what patients truly feel about, or want, from treatment, and a diverse range of outcomes is being used with little consistency between studies. This study aims to address these problems, using established methodology to develop a core outcome set for use in future clinical trials of orthodontic interventions in children and young people. Methods/design: This is a mixed-methods study incorporating four distinct stages. The first stage will include a scoping review of the scientific literature to identify primary and secondary outcome measures that have been used in previous orthodontic clinical trials. The second stage will involve qualitative interviews and focus groups with orthodontic patients aged 10 to 16 years to determine what outcomes are important to them. The outcomes elicited from these two stages will inform the third stage of the study in which a long-list of outcomes will be ranked in terms of importance using electronic Delphi surveys involving clinicians and patients. The final stage of the study will involve face-to-face consensus meetings with all stakeholders to discuss and agree on the outcome measures that should be included in the final core outcome set. Discussion: This research will help to inform patients, parents, clinicians and commissioners about outcomes that are important to young people undergoing orthodontic treatment. Adoption of the core outcome set in future clinical trials of orthodontic treatment will make it easier for results to be compared, contrasted and combined. This should translate into improved decision-making by all stakeholders involved. Trial registration: The project has been registered on the Core Outcome Measures in Effectiveness Trials (COMET) website, January 2016

Supporting dentists' health and wellbeing - a qualitative study of coping strategies in 'normal times'

Background Research has highlighted multiple determinants of dentists' health and wellbeing, and has raised concerns over workforce morale and retention. Limited research has been undertaken on possible solutions. Thus, the aim was to explore the coping strategies used or advocated by dentists to protect and support their health and wellbeing. Methods This qualitative study involved a purposive sample of dentists working in England taking account of age, gender, career stage, work sector, geographical area, position and route of entry to registration. Dentists were approached via gatekeepers across England to participate in semi-structured interviews. A topic guide, informed by past research, was used to guide the discourse. Informants' views were audio-recorded and field notes were made. Data were transcribed and analysed using an interpretative phenomenological approach to generate theory with the support of the framework methodology. Results Twenty dentists were interviewed from a range of backgrounds. Self-reported coping strategies included a range of strategies for 'taking control', including 'embracing self-care' and 'seeking professional support', while drawing on 'supportive personal and social networks'. Managing professional careers included diversifying through greater 'mixing' of NHS with private work, privatising, specialising, or combining dentistry with another role. Strengthening job security and facilitating diversity of experience remain important for supporting the health and wellbeing of dentists. Selling practices or, in the extreme, completely leaving the profession were considered practical options. At organisational level, building sustainable teams and transforming culture were advocated as important; while at systems level, reforming the NHS and bridging the gap between the profession and regulatory body were considered vital. Additionally, the need for strong professional leadership and wider societal debate was advocated as part of a whole systems approach to enable job satisfaction in delivering high-quality, patient-centred, evidence-based care in future. Conclusion While dentists demonstrated a range of coping mechanisms, multi-level action was advocated to enhance the health, wellbeing and retention of dentists. Systems reform at macro- and meso-levels is urgently advocated to enable fulfilling careers within dentistry, particularly for those at the front line of primary dental care in the public sector. Personal resilience alone will not suffice and recommendations for action are explored to avert a public health catastrophe. This is a time for reflection, debate and action

Supporting dentists' health and wellbeing - workforce assets under stress:a qualitative study in England

Background Multiple determinants influence dentists' health and wellbeing. In light of recent concerns, the aim of this research was to explore contemporary influences on dentists' health and wellbeing in England, drawing on their lived experience. Methods Semi-structured interviews were conducted with a purposive sample of dentists working in England, taking into account age, gender, career stage, work sector, geographical area, position and route of entry to registration. A topic guide, informed by the literature, was used to guide the discourse. Dentists were approached via gatekeepers, supported by snowball sampling. Interviews were recorded and transcribed for analysis. Framework analysis was used, taking an interpretative phenomenological approach to develop theory. Results Twenty dentists, from a range of backgrounds, participated in this research. While health and wellbeing was reported to be more positive among dentists in their later career, those in their early career and/or with high NHS work commitments shared concerns about their physical, psychological and emotional health. Influences ranged from macro-level issues relating to professional regulation and health systems, through meso-level, notably their workplace and job specification, to micro-level issues relating to their professional careers, relationships and personal life. Dentists highlighted ethical concerns and feeling driven to deliver, together with being demoralised by a survival culture, all leading to perceived lack of control and reduced professional fulfilment. In contrast, being able to deliver quality care, innovate and effect change, as well as being valued for their delivery, were perceived to positively contribute to general health and wellbeing. Conclusion Dentists have a vital role in providing care for patients, so there are serious public health implications if urgent action is not taken to improve and sustain their health and wellbeing. This study confirms that dentists are affected by multiple contemporary influences, and although greater support is needed for individuals, organisational, system and policy changes may be required to fully address the challenges they face. SUPPLEMENTARY INFORMATION: Zusatzmaterial online: Zu diesem Beitrag sind unter 10.1038/s41415-021-3130-9 für autorisierte Leser zusätzliche Dateien abrufbar

Development of a core outcome set for use in routine orthodontic clinical trials

Introduction A diverse range of outcomes is used in orthodontic research with a focus on measuring outcomes important to clinicians and little consistency in outcome selection and measurement. We aimed to develop a core outcome set for use in clinical trials of orthodontic treatment not involving cleft or orthognathic patient groups. Methods A list of outcomes measured in previous orthodontic research was identified through a scoping literature review. Additional outcomes of importance to patients were obtained using qualitative interviews and focus groups with adolescents aged 10-16 years. Rating of outcomes was carried out in a 2-round electronic Delphi process involving health care professionals and patients using a 9-point scale. A face-to-face meeting was subsequently held with stakeholders to discuss the results before refining the core outcome set. Results After triangulation, a final list of 34 outcomes grouped under 10 domains was obtained for rating in the e-Delphi surveys. Fifteen outcomes were voted “in” after the second Delphi round involving 274 participants with a further outcome being included after the consensus meeting. These were subsequently refined into a final set of 7 core outcomes, including the impact of self-perceived esthetics, alignment and/or occlusion, skeletal relationship, stability, patient-related adherence, breakages, and adverse effects on teeth or teeth-supporting structures. Conclusions A bespoke orthodontic core outcome set encompassing both clinician- and patient-focused outcomes was developed. Incorporating this is the first step into providing a more holistic assessment of the impact of treatment while allowing for meaningful comparisons and synthesis of results from individual trials