Using Smartphone Sensors for Ataxia Trials: Consensus Guidance by the Ataxia Global Initiative Working Group on Digital-Motor Biomarkers.

Smartphone sensors are used increasingly in the assessment of ataxias. To date, there is no specific consensus guidance regarding a priority set of smartphone sensor measurements, or standard assessment criteria that are appropriate for clinical trials. As part of the Ataxia Global Initiative Digital-Motor Biomarkers Working Group (AGI WG4), aimed at evaluating key ataxia clinical domains (gait/posture, upper limb, speech and oculomotor assessments), we provide consensus guidance for use of internal smartphone sensors to assess key domains. Guidance was developed by means of a literature review and a two stage Delphi study conducted by an Expert panel, which surveyed members of AGI WG4, representing clinical, research, industry and patient-led experts, and consensus meetings by the Expert panel to agree on standard criteria and map current literature to these criteria. Seven publications were identified that investigated ataxias using internal smartphone sensors. The Delphi 1 survey ascertained current practice, and systems in use or under development. Wide variations in smartphones sensor use for assessing ataxia were identified. The Delphi 2 survey identified seven measures that were strongly endorsed as priorities in assessing 3/4 domains, namely gait/posture, upper limb, and speech performance. The Expert panel recommended 15 standard criteria to be fulfilled in studies. Evaluation of current literature revealed that none of the studies met all criteria, with most being early-phase validation studies. Our guidance highlights the importance of consensus, identifies priority measures and standard criteria, and will encourage further research into the use of internal smartphone sensors to measure ataxia digital-motor biomarkers.

Assessing Barriers and Facilitators for Implementing Clinical Practice Guidelines in Middle Eastern and North African Region: Delphi Study.

BACKGROUND: Clinical practice guidelines (CPGs) improve clinical decision making and patient outcomes, but CPG implementation is poor. The success of CPGs is influenced by several factors related to barriers and facilitators. For this reason, it can be extremely useful to explore key barriers and facilitators of CPG implementation in the Middle East and North Africa (MENA). METHODS: A three-round Delphi study was performed using the input of 30 experts involved in the clinical practice guidelines. In the first two rounds, participants were asked to score each statement relevant to barriers or facilitators for CPG implementation on a five-point Likert scale. These statements were identified from existing systematic reviews and expert input. In round three, participants ranked the most important barriers and facilitators identified from rounds one and two. A descriptive analysis was conducted on the barrier and facilitators statements using frequencies, percentages, and medians to summarize the variables collected. RESULTS: We identified 10 unique barriers and 13 unique facilitators to CPG implementation within the MENA region. The two highest-ranked barriers related to communications and available research and skills. The most important facilitator was the availability of training courses for healthcare professionals. CONCLUSIONS: Key barriers and facilitators to the implementation of clinical practice guidelines seem to exist in professional, organizational, and external contexts, which should all be taken into account in order to increase implementation success within MENA region. The results of this study are useful in the design of future implementation strategies aimed at overcoming the barriers and leveraging the facilitators.

Exploring the factors that influence stakeholders' expectations and subsequent perception of lower limb orthopaedic surgical outcomes for ambulant children with cerebral palsy - a qualitative study.

PURPOSE: To explore the perspectives of children with CP, their parents or carers, and health professionals on factors affecting expectations and perceptions of surgical outcomes for lower limb orthopaedic surgery. MATERIALS AND METHODS: Semi-structured interviews were conducted with 10 healthcare professionals, 10 children and young people with CP, and 8 parents. Interview data were analysed by content analysis supported by the Framework Approach using the International Classification of Functioning, Disability, and Health (ICF-CY). RESULTS: A comprehensive list of 10 factors including facilitators, barriers, motivational and demotivational factors were identified and categorized into two overreaching themes (Environmental and Personal factors): interdisciplinary collaboration, communication and information resources, holistic care, and shared goal setting are reported as environment facilitators of outcomes expectations. In contrast, reported barriers include lack of time and resources and divergent expectations. Personal motivators include family encouragement, patient's self-determination, and previous experiences, whereas personal demotivators include fear of a new environment. CONCLUSION: The recognition of potential factors influencing expectations and perceptions of surgical outcomes could assist clinical reasoning when planning surgical interventions for ambulant children with CP. If these factors are integrated into the healthcare practice, it will most likely enhance the positive stakeholders' experiences postoperatively.IMPLICATION FOR REHABILITATIONUnderstanding relevant stakeholders' experiences offer a positive contribution to holistic and person-centred approaches in healthcare.People with cerebral palsy and their caregivers require adequate information on surgery and post-surgical rehabilitation regime in order to reach informed decisions.Previous experiences can influence surgical expectations and subsequent perceptions of the outcome.

A core outcome set for lower limb orthopaedic surgery for children with cerebral palsy: An international multi-stakeholder consensus study.

AIM: To develop a core set of outcome domains to be measured in clinical studies on lower limb orthopaedic surgery for ambulant children with cerebral palsy (CP) that represents the priorities of an international multi-stakeholder group (children, parent/carers, and health professionals). METHOD: Potential outcome domains were identified through literature review and qualitative interviews with key stakeholders. These were scored in an international two-round Delphi survey, using a 9-point Likert scale. A final consensus meeting with key stakeholders agreed on the most important outcome domains and refined the core outcome set (COS). RESULTS: One hundred and sixty-one health professionals and 36 individuals with CP and their parents/carers rated 21 of 41 outcomes as important in the Delphi survey. The final consensus group agreed 19 outcomes within eight domains to be included in the final COS: pain and fatigue, lower limb structure, motor function, mobility (daily life activities), gait-related outcomes, physical activity, independence, and quality of life. INTERPRETATION: A COS for lower limb orthopaedic surgery for children with CP was developed. Incorporating this in the design of future clinical studies will provide a more holistic assessment of the impact of treatment while allowing meaningful comparisons and future synthesis of results from primary studies. WHAT THIS PAPER ADDS: Eight core outcome domains were identified as important to measure in future clinical research. Key stakeholders perceived pain, balance and fall, and independence as very important outcomes. Six contextual factors were identified as essential in surgical decision-making.

Outcomes of importance to children and young adults with cerebral palsy, their parents and health professionals following lower limb orthopaedic surgery: A qualitative study to inform a Core Outcome Set.

INTRODUCTION: Although several outcomes are commonly measured to assess the effect of surgery for young people with cerebral palsy (CP), these are selected mainly by health professionals and researchers. Including the perspectives of a broader range of stakeholders is an essential step towards determining important outcomes for assessment. This qualitative study involves the development of a core outcome set (COS) for lower limb orthopaedic surgery for ambulant children with CP. OBJECTIVE: This study aimed to identify outcomes that matter to children and young people with CP, their parents and healthcare professionals following lower limb orthopaedic surgery. METHODS: Semi-structured interviews were conducted with 10 healthcare professionals, 10 children and young people with CP and 8 parents. Interview data were analysed by content analysis supported by the International Classification of Functioning, Disability and Health (ICF-CY) supplemented by thematic analysis. FINDINGS: Thirty-one outcomes were identified in total, which were linked to eleven second-level ICF-CY categories. There were differences between stakeholder groups in preferences and expectations from surgical outcomes. Healthcare professionals and children with their parents identified 31 and 25 outcomes, respectively. Health outcomes valued by participants were lower limb alignment and symmetry, flexibility and muscle strength, mental health, fatigue, pain, function in life, mobility, participation, being independent, quality of life and adverse events. Compared to previous published trials, 10 new outcomes were revealed by this study. CONCLUSION: The researchers identified outcomes that are important to all stakeholders following lower limb orthopaedic surgery for ambulant CP. Including these outcomes in future studies would promote patient-centred care for children and young adults with CP. Findings will be used to inform an international Delphi survey and develop a COS in this field. PATIENT AND PUBLIC CONTRIBUTION: This study was informed by an advisory group including a young adult with CP and a parent of a child with CP. This group engaged in the design of the study and the information material to support the interview (information sheet and interview topic guide).

An exploration of occupational choices in adolescence: A constructivist grounded theory study.

BACKGROUND: Adolescence is a critical period within the life course, for developing adult occupational competencies and health behaviours. Few studies have considered how 16-17 year olds choose activities and behaviours from an occupational perspective. AIM AND OBJECTIVES: To explore how adolescents aged 16-17 years old make choices about their daily occupations to inform a theoretical model of occupational choice. MATERIALS AND METHODS: About 27 secondary school students aged 16-17 years attended one of six focus groups. Transcripts were analyzed using constructivist grounded theory, informing the iterative development of a theoretical model of occupational choice. RESULTS: Adolescent occupational choice occurred in response to experiencing needs, and was characterized by 'weighing up' and 'juggling' the following four key domains: 'Appraising values and priorities', 'Interacting with the situational context', 'Exploring skills and occupational repertoire' and 'Considering time factors'. A developing sense of responsibility and autonomy for occupational choices was described, leading to the development of the future occupational self. CONCLUSIONS AND SIGNIFICANCE: A theory illuminating how adolescents make choices was developed. The theory aligns with existing developmental literature and provides unique insights, from an occupational science perspective, on the conscious process by which adolescents make, develop and adapt choices about the occupations they do considering contextual and individual opportunities and constraints.

Patients' and parents' views about lower limb orthopaedic surgery for ambulant children and young people with cerebral palsy: a qualitative evidence synthesis.

PURPOSE: The article identifies the aspects of health and outcomes that are considered important from the perspective of ambulatory children with cerebral palsy (CP) and their parents regarding lower limb orthopaedic surgery and explores how they experience surgical interventions. METHODS: Four databases (Embase, MEDLINE (Ovid), CINAHL and PsycINFO) were searched from inception to 11 April 2020. Studies were included if they: 1) they involved children or young adults diagnosed with ambulant CP or their family, 2) participants had experience with lower limb orthopaedic surgery and 3) studies employed qualitative research methods. The Critical Appraisal Skills Programme was used to appraise identified studies. The 'Best-fit framework' synthesis approach was used by applying the International Classification of Functioning-Children and Youth (ICF-CY) linking rules and thematic synthesis. The review process was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. RESULTS: Six studies were included. Four themes were generated which were linked to the ICF-CY framework: Body function and structure, Activity and participation, Environmental factors, Personal factors, as well as non-ICF-CY themes including Emotional well-being and Goal setting. Important surgical outcomes identified were pain, fatigue, movement-related function, mobility, walking ability, community life, emotional well-being, and adequate provision of public and health services. CONCLUSION: These findings are important for understanding patient-centred outcomes in lower limb ortho-paedics surgery and providing focus for future interventional studies aimed at improving outcomes of importance to children with CP. These findings highlight the importance of long-term support to help people negotiate the challenge of surgical regimes and to achieve good outcomes after orthopaedic surgery. The outcomes identified will contribute to the development of a core outcome set in this field. LEVEL OF EVIDENCE: III.

Outcome domains and measures after lower limb orthopaedic surgery for ambulant children with cerebral palsy: an updated scoping review.

AIM: To determine the reported outcome domains and measures used to assess lower limb orthopaedic surgery of ambulant children and young people with cerebral palsy (CP) and map these outcomes to the International Classification of Functioning, Disability and Health - Children and Youth (ICF-CY) framework. METHOD: This updated scoping review included studies published between January 2016 and July 2019 in five databases: MEDLINE, PubMed, EMBASE, CINAHL, and the Cochrane Central Register of Controlled Trials. Studies were included if participants were ambulant individuals with CP aged between 0 and 20 years who had undergone lower limb orthopaedic surgery. Health outcome domains and measures were identified and classified using the ICF-CY framework. RESULTS: Forty-four eligible studies were identified with a total of 40 different outcome domains recorded. Among eligible studies, 44 (100%) measured body function and structural impairment and seven (16%) measured activity limitation and participation restriction. The most frequently reported outcome was gait pattern (n=37, 84%). Few studies reported adverse effects of surgery (n=13, 30%). Twenty-nine different outcome measures were identified. Patient-reported outcomes measures were used in 10 studies (23%). INTERPRETATION: The review highlights a heterogeneity in the reported outcome domains and measures used in CP studies. The majority of the reported outcomes focus on the ICF-CY domain of body function and structure. The review also highlights a notable shift towards patient-reported outcomes in recent years. Development of a core outcome set for lower limb orthopaedic surgery would guide researchers to use more consistent and complete measurement sets.

Development of a core outcome set for lower limb orthopaedic surgical interventions in ambulant children and young people with cerebral palsy: a study protocol.

INTRODUCTION: Musculoskeletal deformities and gait deviations are common features in ambulatory cerebral palsy (CP). Deformity correction through lower limb orthopaedic surgery is the standard form of care aimed at improving or preserving motor function. Current research on CP care does not always take into account individual patients' expectations and needs. There is a wide range of outcome domains and outcome measures used to assess outcome from treatment. This can lead to reporting bias and make it difficult to compare and contrast studies. A core outcome set (COS) would enhance the efficiency, relevance and overall quality of CP orthopaedic surgery research. The aim of this study is to establish a standardised COS for use in evaluating lower limb orthopaedic surgery for ambulatory children and young people with CP. METHODS/ANALYSIS: A set of outcomes domains and outcome measures will be developed as follows: (1) a qualitative evidence synthesis to identify relevant outcomes from children and young people and family perspective; (2) a scoping review to identify relevant outcomes and outcome measures; (3) qualitative research to explore the experience of key stakeholders; (4) prioritisation of outcome domains will be achieved through a two-round Delphi process with key stakeholders; (5) a final COS will be developed at a consensus meeting with representation from key stakeholder groups. ETHICS AND DISSEMINATION: Ethical approval for this study was granted in the UK by the Oxfordshire Research Ethics Committee B (REC reference 19/SC/0357). Informed consent will be obtained from participants taking part in the qualitative research and Delphi process. Study findings will be published in an open access journal and presented at relevant national and international conferences. Charities and associations will be engaged to promote awareness of the project COS results. TRIAL REGISTRATION NUMBER: COMET registration: 1236. PROSPERO REGISTRATION NUMBER: CRD42018089538.