Development of a quality of life measure for left ventricular assist device recipients using a mixed methods approach.

BACKGROUND: Left ventricular assist device (LVAD) recipients report symptom improvement but find adjusting to life with the LVAD challenging. These challenges are unique, and existing patient-reported outcome measures (PROMs) do not reflect their experiences. This study aimed to develop a culturally relevant quality of life PROM for use with LVAD recipients in future research, design evolutions and clinical practice. METHODS: A three-stage mixed-methods approach was used to develop a PROM: stage 1 included group concept mapping (GCM); stage 2 semi-structured qualitative interviews were conducted with 11 LVAD recipients and 10 clinicians, and a questionnaire was developed using a conceptual framework; and stage 3 used exploratory psychometric analysis of the PROM data using Rasch measurement theory. This paper presents stages 2 and 3. RESULTS: The conceptual framework consisted of four key concepts, including general health, life with the LVAD, equipment and clothing and emotional impact. Statements from interviews and GCM were used to create items for the LVAD quality of life (LVAD-QoL). Cognitive interviews tested face validity and participant comprehension. Forty-nine participants were recruited from three UK transplant centres. PROM data were collected and analysed using Rasch analysis. Four items displayed misfit; dependency between item sets was the biggest issue (57/485 pairwise differences). After restructuring and dealing with item misfit, the LVAD-QoL conformed to the Rasch model, supporting the psychometric properties and quality of the LVAD-QoL. CONCLUSIONS: Using a mixed-methods approach ensured the development of a robust and psychometrically sound tool for research, design evolution and clinical practice with LVAD recipients.

Identifying patient-valued outcomes for use in early phase trials of ocular surface disease interventions.

BACKGROUND: Patient-reported outcomes (PROs) can be used to evaluate the impact of dry eye symptoms (DES) on daily life. Early-phase clinical trials provide an opportunity to evaluate PRO strategies. Existing measures identified through systematic review omitted important concepts that mattered to patients. The aim of our work was to develop a conceptual map of DES and assess the relative importance of identified concepts. METHODS: Web-based group concept mapping software was used to develop a conceptual map. This semi-quantitative mixed-methods approach consists of three stages 1) statement generation, 2) thematic sorting, 3) rating of statements for importance [1 (not important), 2 (important), 3 (very important)] and relevance [1 (not my experience), 2 (sometimes my experience); 3 (definitely my experience)]. Thirty-nine participants were recruited from two UK-based patient support groups (British Sjögren's Syndrome Association, PemFriends). Three withdrew, two for health reasons and one struggled with the web-based format. RESULTS: 125 statements and six thematic clusters were generated. The Environmental Impacts cluster scored highest for importance (2.45), followed by Pain and Discomfort (2.35), Eye Treatments (2.32), Daily Impact (2.07), Psychosocial Issues (1.78) and Miscellaneous (1.78). Mapping statements against existing PRO measures confirmed a number of important missing issues including the impact of 'UV levels' (2.50), hot dry weather (2.33), the temporal aspects of pain (2.64), and issues with night-driving (2.59). CONCLUSIONS: Group concept mapping identified important issues for people living with DES not currently captured by existing PROs, highlighting the need for additional PRO items to be considered for use in clinical trials.

Living with a left ventricular assist device: Capturing recipients experiences using group concept mapping software.

BACKGROUND: Left ventricular assist device (LVAD) implantation significantly impacts on a recipient's symptoms and quality of life. Capturing their experiences and post implant journey is an important part of clinical practice, research and device design evolution. Patient reported outcome measures (PROMs) are a useful tool for capturing that experience. However, patient reported outcome measures need to reflect recipients' experiences. Discussions with a patient partner group found that none of the frequently used cardiology PROMs captured their unique experiences. AIMS: To capture the experiences and important issues for LVAD recipients. Develop a conceptual map of domains and items that should be reflected in patient reported outcomes. METHODS: Group concept mapping (GCM) web-based software was used to remotely capture and structure recipients' experiences across a wide geographical area. GCM is a semi-quantitative mixed method consisting of 3 stages: item generation, item sorting and rating (importance, relevance and frequency). Patient partners were involved in all aspects of the study design and development. RESULTS: 18 LVAD recipients consented to take part. 101 statements were generated and multi-dimensional scaling, and hierarchical cluster analysis identified 9 clusters. Cluster themes included: Activities, Partner/family support, Travel, Mental wellbeing, Equipment and clothing, Physical and cognitive limitations, LVAD Restrictions, LVAD Challenges and positive impact of the LVAD (LVAD Positives). LVAD Positives were scored highest across all the rating variables, e.g., frequency (2.85), relevance (2.44) and importance (2.21). Other domains rated high for importance included physical and cognitive limitations (2.19), LVAD restrictions (2.11), Partner/family support (2.02), and Equipment and clothing (2.01). CONCLUSION: Online GCM software facilitated the inclusion of geographically dispersed recipients and provided useful insights into the experiences of LVAD recipients. The conceptual framework identifies important domains and items that should be prioritised and included in patient reported outcomes in future research, LVAD design evolution, and clinical practice.

The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis.

BACKGROUND: Patient-reported outcomes (PROs) are commonly collected in clinical trials and should provide impactful evidence on the effect of interventions on patient symptoms and quality of life. However, it is unclear how PRO impact is currently realised in practice. In addition, the different types of impact associated with PRO trial results, their barriers and facilitators, and appropriate impact metrics are not well defined. Therefore, our objectives were: i) to determine the range of potential impacts from PRO clinical trial data, ii) identify potential PRO impact metrics and iii) identify barriers/facilitators to maximising PRO impact; and iv) to examine real-world evidence of PRO trial data impact based on Research Excellence Framework (REF) impact case studies. METHODS: Two independent investigators searched MEDLINE, EMBASE, CINAHL+, HMIC databases from inception until December 2018. Articles were eligible if they discussed research impact in the context of PRO clinical trial data. In addition, the REF 2014 database was systematically searched. REF impact case studies were included if they incorporated PRO data in a clinical trial. RESULTS: Thirty-nine publications of eleven thousand four hundred eighty screened met the inclusion criteria. Nine types of PRO trial impact were identified; the most frequent of which centred around PRO data informing clinical decision-making. The included publications identified several barriers and facilitators around PRO trial design, conduct, analysis and report that can hinder or promote the impact of PRO trial data. Sixty-nine out of two hundred nine screened REF 2014 case studies were included. 12 (17%) REF case studies led to demonstrable impact including changes to international guidelines; national guidelines; influencing cost-effectiveness analysis; and influencing drug approvals. CONCLUSIONS: PRO trial data may potentially lead to a range of benefits for patients and society, which can be measured through appropriate impact metrics. However, in practice there is relatively limited evidence demonstrating directly attributable and indirect real world PRO-related research impact. In part, this is due to the wider challenges of measuring the impact of research and PRO-specific issues around design, conduct, analysis and reporting. Adherence to guidelines and multi-stakeholder collaboration is essential to maximise the use of PRO trial data, facilitate impact and minimise research waste. TRIAL REGISTRATION: Systematic Review registration PROSPERO CRD42017067799.

1000 fieldwork hours: analysis of multi-site evidence.

BACKGROUND: Internationally, the World Federation of Occupational Therapists has established a minimum of 1,000 hours as the fieldwork standard. PURPOSE: To examine student development in fieldwork across placements to determine if students achieve entry-level competence after completion of 1,000 hours of fieldwork. METHODS: Archival data (N=400) from six occupational therapy programs were analyzed to examine the acquisition of fieldwork competency over time as measured by the Competency Based Fieldwork Evaluation Scale. FINDINGS: Competency scores increased with each fieldwork placement, the majority of students achieved entry-level scores upon completion of their final fieldwork placement. While, on average, some competency scores exceeded entry level by 1,000 hours, Practice Knowledge, Clinical Reasoning, and Facilitating Change fell just short. IMPLICATIONS: The identification of a plan for addressing the lower ratings in these three competencies should be considered.

Evaluation of the psychometric properties of the upper limb subscales of the Motor Assessment Scale using a Rasch analysis model.

OBJECTIVES: To apply Rasch analysis to evaluate the psychometric properties of the composite score of the 3 upper limb subscales of the Motor Assessment Scale (UL-MAS) when administered in the acute/subacute phase post-stroke. DESIGN: Prospective data collection of UL-MAS scores. PARTICIPANTS: Eighty Eighty individuals a mean of 64.8 days (standard deviation 53.3; range 4-193 days) following the onset of unilateral stroke. METHODS: All UL-MAS test items were administered in 30 participants assessed longitudinally over 3 occasions, and in 50 participants assessed on a single occasion. These 140 observations were pooled to be evaluated using Rasch analysis. RESULTS: With the elimination of the wrist radial deviation test item, the UL-MAS demonstrated uni-dimensionality with no significant test item response bias. The test item difficulty hierarchy was validated in the Upper Arm and Hand Movements subscales, but not in the Advanced Hand Activities subscale. The acceptable floor (14%) and ceiling (9%) effects and the high Person Separation Reliability Index (0.96) indicated that the scale was appropriately targeted to discriminate statistically between groups of acute/subacute stroke participants with differing upper limb motor recovery. CONCLUSION: The findings support the psychometric properties of the composite UL-MAS score in this clinical population.