Making it transparent: A worked example of articulating programme theory for a digital health application using Intervention Mapping.

Objective: Digital health interventions for behaviour change are usually complex interventions, and intervention developers should 'articulate programme theory', that is, they should offer detailed descriptions of individual intervention components and their proposed mechanisms of action. However, such detailed descriptions often remain lacking. The objective of this work was to provide a conceptual case study with an applied example of 'articulating programme theory' for a newly developed digital health intervention. Methods: Intervention Mapping methodology was applied to arrive at a detailed description of programme theory for a newly developed digital health intervention that aims to support cardiac rehabilitation patients in establishing heart-healthy physical activity habits. Based on a Predisposing, Reinforcing, and Enabling Constructs in Educational Diagnosis and Evaluation (PRECEDE) logic model of the problem, a logic model of change was developed. The proposed mechanisms of action were visualised in an acyclic behaviour change diagram. Results: Programme theory for this digital health intervention includes 4 sub-behaviours of the main target behaviour (i.e. habitual heart-healthy physical activity), 8 personal determinants and 12 change objectives (i.e. changes needed at the determinant level to achieve the sub-behaviours). These are linked to 12 distinct features of the digital health intervention and 12 underlying behaviour change methods. Conclusions: This case study offers a worked example of articulating programme theory for a digital health intervention using Intervention Mapping. Intervention developers and researchers may draw on this example to replicate the method, or to reflect on most suitable approaches for their own behaviour change interventions.

Use of co-design methodology in the development of cardiovascular disease secondary prevention interventions: A scoping review.

INTRODUCTION: There is growing evidence to support the use of co-design in developing interventions across many disciplines. This scoping review aims to examine how co-design methodology has been used in the development of cardiovascular disease (CVD) secondary prevention interventions within health and community settings. METHODS: We searched four academic databases for studies that used the co-design approach to develop their intervention. Studies were included if consumers (adults with CVD) and key stakeholders (e.g. clinicians, service providers) were involved in the co-design process. The review focused on methodology rather than traditional study outcomes; therefore, co-design processes and activities were extracted and evaluated against a selected co-design framework. RESULTS: Twenty-two studies were included in this review. Studies were implemented across various settings with consumers and stakeholder groups most frequently consisting of patients and healthcare professionals, respectively. Most studies specifically stated that they used a 'co-design' approach (n = 10); others used terms such as participatory action research (n = 3), user-centred design (n = 3) and community-based participatory research (n = 2). Although there was variability in terminology, co-design processes, and participants, all studies adhered to the key principles of consumer engagement. Predominant co-design activities included semistructured interviews, focus groups, co-design/development workshops and advisory group meetings. Intervention effectiveness was assessed in eight studies showing mixed results. CONCLUSIONS: This review provides an overview of how the co-design approach has previously been used in the development of CVD secondary prevention interventions. These findings provide methodological considerations that can guide researchers and healthcare services when implementing co-design to develop feasible and acceptable interventions that can improve outcomes for CVD populations. PATIENT OR PUBLIC CONTRIBUTION: No patients, service users, caregivers, people with lived experience or members of the public were involved in this scoping review. This review article was written by academics who have undertaken a significant amount of co-design work with consumers and stakeholders.

Chin tuck against resistance exercise with feedback to improve swallowing, eating and drinking in frail older people admitted to hospital with pneumonia: protocol for a feasibility randomised controlled study.

BACKGROUND: Swallowing difficulties (dysphagia) and community-acquired pneumonia are common in frail older people and maybe addressed through targeted training of the anterior neck musculature that affects the swallow. We have developed a swallowing exercise rehabilitation intervention (CTAR-SwiFt) by adapting a previously established swallowing exercise to ensure patient safety and ease of execution in the frail elderly population. The CTAR-SwiFt intervention consists of a feedback-enabled exercise ball that can be squeezed under the chin, with real-time feedback provided via a mobile application. The aim of this study is to evaluate the feasibility of assessing the effectiveness of the CTAR-SwiFt intervention in reducing dysphagia and community-acquired pneumonia, prior to a larger-scale multi-centre randomised controlled trial. METHODS: We will recruit 60 medically stable patients over the age of 75 years who have been admitted with a diagnosis of pneumonia to the acute frailty wards at two participating hospitals in the UK. Study participants will be randomised into one of three groups: standard care, low intensity (once daily) CTAR-SwiFt exercise or high intensity (twice daily) CTAR-SwiFt exercises. The intervention period will last for 12 weeks, the final follow-up assessment will be conducted at 24 weeks. We will assess the feasibility outcomes, including rates of participant recruitment and retention, compliance with the exercise regime and adverse incidents. Additionally, we will assess the usability and acceptability of the intervention device and the performance of different clinical outcome measures (e.g. chin tuck strength, Functional Oral Intake Scale, SWAL-QOL, EQ-5D and swallow speed). A sub-sample of study participants will complete videofluoroscopic assessments of swallowing function before and after the intervention to evaluate the physiological changes (e.g. bolus flow rates, laryngeal elevation, base-of-tongue retraction). CONCLUSIONS: By improving the ability to swallow, using our chin tuck exercise intervention, in frail older patients admitted to hospital with pneumonia, it is anticipated that patients' oral intake will improve. It is suggested that this will further impact clinical, patient and healthcare economic outcomes, i.e. reduce the need for supplemental feeding, improve patient satisfaction with oral intake and swallowing-related quality of life, decrease the occurrence of chest infections and reduce hospital admissions and related healthcare costs. TRIAL REGISTRATION: ISRCTN, ISRCTN12813363 . Registered on 20 January 2020.

Doing nothing? An ethnography of patients' (In)activity on an acute stroke unit.

Health research has begun to pay increasing attention to inactivity in its broadest sense as lack of meaningful activity and boredom. Few studies however have taken a critical look at this phenomenon. We explore (in)activity drawing on ethnographic data from observations in an acute stroke unit and post-discharge interviews with stroke survivors and their families. Four themes emerged that explain patients' (in)activity: (i) planned activities; (ii) 'doing nothing', (iii) the material environment of the unit; (iv) interactions with staff. Considering these themes, we seek to problematise received conceptual and methodological approaches to understanding (in)activity. We argue that (in)activity is best conceived not as lack of action or meaning, but as a situated practice encompassing both bodily and mental activities that reflect and reproduce the way in which life is collectively organised within a specific healthcare setting.

Effects of Finding the Speech-Language Pathologist Likeable on Postlaryngectomy Speech Intelligibility Outcomes.

INTRODUCTION: Speech-language pathologists (SLPs) work with patients after total laryngectomy (TL) to regain verbal communication. The influence of the quality of the therapeutic relationship on the success of TL voice rehabilitation in terms of speech intelligibility is not known. Finding each other likeable is an important factor in establishing and maintaining interpersonal relationships in everyday life. The fit of therapist and client is relevant to the therapeutic relationship. The purpose of this study therefore was to assess the association between the degree of SLPs' likeability ratings and postlaryngectomy speech intelligibility. METHODS: In a multicentre prospective cohort study, participants rated their SLPs' likeability after finishing TL rehabilitation. Speech intelligibility was measured objectively with the Post-Laryngectomy Telephone Intelligibility Test and subjectively with the Questionnaire for Adjustment after Laryngectomy. The association of SLPs' likeability with speech intelligibility was analysed using hierarchical logistic regression, expressed with odds ratios (OR) with corresponding 95% confidence intervals (CI). RESULTS: Altogether 124 patients from 13 institutions participated. The degree of finding the SLP likeable was not significantly associated with objective speech intelligibility (OR 1.30; 95% CI 0.78-2.18; p = 0.32) or subjective speech intelligibility (OR 1.01; 95% CI 0.60-1.72; p = 0.96) after controlling for age, sex and education factors. DISCUSSION/CONCLUSION: In this patient cohort, there was no evidence for an association between ratings of SLPs' likeability and speech intelligibility outcomes after rehabilitation. Future studies could consider the use of alternative instruments for measuring likeability.

A qualitative study of views on disability and expectations from community rehabilitation service users.

Conceptualisations of disability influence perspectives in clinical rehabilitation. The individual model and the social model framing of disability offer differing interpretations of the causality of problems and suggested actions to achieve improvement. Current rehabilitation practice centres on a problem-solving goal-oriented approach. How clients and professionals think about disability will invariably influence reasoning and suggestions for action. We explored these issues in a convenience sample of 10 community rehabilitation service users in London, United Kingdom. We took a phenomenological approach, aiming to discover interviewees' individual experiences and conceptualisations of disability, and expectations from community rehabilitation. Semi-structured qualitative interviews were conducted from June to August 2011. Interview transcripts were analysed through open coding, constant comparison and thematic analysis. Participants constituted a group of older adults with acquired impairments and diverse medical background. Participants generally understood disability according to the individual model. There was a lack of self-identification as disabled and of explicit socio-political views on disability. This seemed to correlate with participants' life course and the experience of impairments and increasing vulnerability with old age. However, accounts of interviewees' current difficulties in life provided examples of the applicability and relevance of social model thinking. Participants' expectations from community rehabilitation ranged from those who had no clear expectations and took a passive service user role to those who had concrete wishes and were actively engaged with the service. Our interpretation of these findings is that it may be necessary to raise the public profile of community rehabilitation as a service; and that there is scope for conceptual work to actively develop and incorporate alternative ways of looking at disability into clinical rehabilitation practice.

Higher cough flow is associated with lower risk of pneumonia in acute stroke.

UNLABELLED: There is little available evidence to demonstrate how cough strength mediates the risk of aspiration-related pneumonia in acute stroke. Our secondary analysis of trial data indicates that risk of pneumonia reduces with increasing peak cough flow (PCF) of voluntary cough (OR 0.994 for each 1 L/min increase in PCF, 95% CI 0.988 to 1.0, p=0.035); and to a lesser degree with increasing PCF of reflex cough (OR 0.998 for each 1 L/min increase in PCF, 95% CI 0.992 to 1.004, p=0.475). These data serve hypothesis generation. Further studies are needed to confirm these findings and validate their clinical utility. CLINICAL TRIAL REGISTRATION NUMBER: ISRCTN40298220 (post-results).

Cough frequency monitors: can they discriminate patient from environmental coughs?

BACKGROUND: Objective cough frequency measurements are increasingly applied in clinical research. Technological advances enable automated detection and counting of cough events from sound recordings of many hours' duration. A possible limitation of sound-based cough frequency measurement is the contamination of recordings by environmental coughs (coughs from persons other than the patient). This study aimed to investigate the accuracy of a sound-based cough monitor for detecting and discriminating patient cough from environmental cough. METHODS: As part of a stroke trial (ISRCTN40298220), patients on a hospital ward underwent 15-minute recordings using the Leicester Cough Monitor (LCM), a sound-based cough monitor ('semi-automated counts'). Participants and other persons in the environment were prompted to cough. An observer present in the room recorded the number of patient and environmental coughs ('live counts'). LCM counts were also compared against a manual cough count, the most commonly used gold standard to determine accuracy ('manual sound counts' from listening to recordings), by a blinded assessor who cross-referenced timed cough events from the respective methods. Data for automated, manual and live cough counts were analyzed using agreement statistics. RESULTS: On sound recordings from five patients, there were 65 patient coughs and 78 environmental coughs (manual counts). Absolute agreement for patient cough count between all three measurement methods (LCM automated, live, and manual sound counts) was high, with intra-class correlation coefficient of 0.94 [95% confidence intervals (CI): 0.74, 0.99]. The proportion of exact agreements for patient cough between LCM and manual count was 0.92, and kappa was 0.84 (95% CI: 0.75, 0.93). The LCM showed sensitivity of 0.94 (95% CI: 0.84, 0.98), specificity of 0.91 (95% CI: 0.82, 0.96), positive predictive value of 0.90 (95% CI: 0.79, 0.95) and negative predictive value of 0.95 (95% CI: 0.86, 0.98) for detecting patient coughs. CONCLUSIONS: This preliminary study supports the validity of the cough monitor for detecting and discriminating patient from environmental cough. Further validation is recommended, to describe the level of accuracy with greater precision.

WHODAS 2.0 in community rehabilitation: a qualitative investigation into the validity of a generic patient-reported measure of disability.

PURPOSE: The World Health Organization Disability Assessment Schedule (WHODAS 2.0) was considered as a potentially appropriate patient-reported outcome measure (PROM) for community rehabilitation services in the UK. The study explored qualitative aspects of the measure's content and content and construct validity. METHOD: A convenience sample of 10 community rehabilitation service users participated in semi-structured interviews and completed the WHODAS 2.0. Content analysis and a constant comparative method of analysis were applied. Participants' accounts were compared with the measure's content and its underlying construct of disability. RESULTS: Participants' reports of current difficulties were rich with accounts of bodily impairments and activity and participation limitations. WHODAS 2.0 content largely covered those activities that interviewees found difficult. Participants tended to conceptualize disability according to the medical model. The wording of the questionnaire allowed for ambiguity with respect to social perspectives on disability, which resulted in variability of scores. CONCLUSIONS: While WHODAS 2.0 content coverage appears comprehensive, the questionnaire in its current form tends to favor a medical construct of disability. We recommend caution when applying WHODAS 2.0 in contexts such as community rehabilitation, where social aspects of disability may be considered important. Further investigation of the measure's construct validity might be warranted.