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Patient-reported outcomes (PROs) are used in clinical trials to provide valuable evidence on the impact of disease and treatment on patients' symptoms, function and quality of life. High-quality PRO data from trials can inform shared decision-making, regulatory and economic analyses and health policy. Recent evidence suggests the PRO content of past trial protocols was often incomplete or unclear, leading to research waste. To address this issue, international, consensus-based, PRO-specific guidelines were developed: the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-PRO Extension. The SPIRIT-PRO Extension is a 16-item checklist which aims to improve the content and quality of aspects of clinical trial protocols relating to PRO data collection to minimise research waste, and ultimately better inform patient-centred care. This SPIRIT-PRO explanation and elaboration (E&E) paper provides information to promote understanding and facilitate uptake of the recommended checklist items, including a comprehensive protocol template. For each SPIRIT-PRO item, we provide a detailed description, one or more examples from existing trial protocols and supporting empirical evidence of the item's importance. We recommend this paper and protocol template be used alongside the SPIRIT 2013 and SPIRIT-PRO Extension paper to optimise the transparent development and review of trial protocols with PROs. ispartof: BMJ OPEN vol:11 issue:6 ispartof: location:England status: published

Objectives(a) To adapt the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)-patient-reported outcome (PRO) Extension guidance to a user-friendly format for patient partners and (b) to codesign a web-based tool to support the dissemination and uptake of the SPIRIT-PRO Extension by patient partners.DesignA 1-day patient and public involvement session.ParticipantsSeven patient partners.MethodsA patient partner produced an initial lay summary of the SPIRIT-PRO guideline and a glossary. We held a 1-day PPI session in November 2019 at the University of Birmingham. Five patient partners discussed the draft lay summary, agreed on the final wording, codesigned and agreed the final content for both tools. Two additional patient partners were involved in writing the manuscript. The study compiled with INVOLVE guidelines and was reported according to the Guidance for Reporting Involvement of Patients and the Public 2 checklist.ResultsTwo user-friendly tools were developed to help patients and members of the public be involved in the codesign of clinical trials collecting PROs. The first tool presents a lay version of the SPIRIT-PRO Extension guidance. The second depicts the most relevant points, identified by the patient partners, of the guidance through an interactive flow diagram.ConclusionsThese tools have the potential to support the involvement of patient partners in making informed contributions to the development of PRO aspects of clinical trial protocols, in accordance with the SPIRIT-PRO Extension guidelines. The involvement of patient partners ensured the tools focused on issues most relevant to them.

Rationale & Objective Chronic kidney disease (CKD) can substantially affect patients' health-related quality of life. Electronic patient-reported outcome measures (ePROMs) may capture symptoms and health-related quality of life and assist in the management of CKD. This study explored patient and clinician views on the use of a renal ePROM system. Study Design Qualitative study. Setting & Participants 12 patients with stage 4 or 5 CKD (non–dialysis dependent); 22 clinicians (6 CKD community nurses, 1 clinical psychologist, 10 nephrologists, 3 specialist registrars, and 2 renal surgeons) in the United Kingdom. Analytical Approach Semi-structured interviews and focus group discussion during which patients received paper versions of the Kidney Disease Quality of Life-36 and the Integrated Patient Outcome Scale-Renal to exemplify the type of content that could be included in an ePROM. Thematic analysis of interview transcripts. Results 4 themes were identified: (1) general opinions of PROMs, (2) potential benefits and applications of an ePROM system, (3) practical considerations for the implementation of ePROMs, and (4) concerns, barriers, and facilitators. Patients were willing to complete ePROMs on a regular basis as part of their care despite clinician concerns about patient burden. Patients assessed the questionnaires favorably. Clinicians suggested that the extent of adoption of renal ePROM systems in routine clinical settings should be based on evidence of significant impact on patient outcomes. Clinicians were concerned that an ePROM system may raise patient expectations to unrealistic levels and expose clinicians to the risk for litigation. Patients and clinicians identified potential benefits and highlighted issues and concerns that need to be addressed to ensure the successful implementation of the renal ePROM system. Limitations Transferability of the findings may be limited because only English-speaking participants were recruited to the study. Conclusions A renal ePROM system may play a supportive role in the routine clinical management of patients with advanced CKD if the concerns of clinicians and patients can be sufficiently addressed.

Increased survival rates from traumatic injury have resulted in more people living with disability and reduced quality of life. To understand how peoples' quality of life is affected following a traumatic injury and the effects of that injury on their health and well-being, it is important to capture patients' perspectives of their own health. Patient-reported outcome measures (PROMs) are questionnaires, completed by patients, which can be used to measure the symptom burden associated with trauma and its treatment, and impact on quality of life. Patient-reported outcome measures have a wide variety of uses that are relevant to trauma. In a research setting, PROMs can be used to assess the effectiveness of treatment and burden of disease. In a clinical setting, PROMs have the potential to inform and guide patient-centered care and clinical decision making. Collected as part of trauma registries, PROMs can be used at an aggregate level to inform improvements and uphold the quality of trauma care. This literature review explores and summarizes the key current and potential future uses of PROMs in trauma research, routine clinical practice, and registries.

BackgroundPatient-reported outcomes (PROs) are used in clinical trials to assess the effectiveness and tolerability of interventions. Inclusion of participants from different ethnic backgrounds is essential for generalisability of cancer trial results. PRO data collection should include appropriately translated patient-reported outcome measures (PROMs) to minimise missing data and sample attrition.MethodsProtocols and/or publications from cancer clinical trials using a PRO endpoint and registered on the National Institute for Health Research Portfolio were systematically reviewed for information on recruitment, inclusion of ethnicity data, and use of appropriately translated PROMs. Semi-structured interviews were conducted with key stakeholders to explore barriers and facilitators for optimal PRO trial design, diverse recruitment and reporting, and use of appropriately translated PROMs.ResultsEighty-four trials met the inclusion criteria, only 14 (17%) (n = 4754) reported ethnic group data, and ethnic group recruitment was low, 611 (13%). Although 8 (57%) studies were multi-centred and multi-national, none reported using translated PROMs, although available for 7 (88%) of the studies.Interviews with 44 international stakeholders identified a number of perceived barriers to ethnically diverse recruitment including diverse participant engagement, relevance of ethnicity to research question, prominence of PROs, and need to minimise investigator burden. Stakeholders had differing opinions on the use of translated PROMs, the impact of trial designs, and recruitment strategies on diverse recruitment. Facilitators of inclusive research were described and examples of good practice identified.ConclusionsGreater transparency is required when PROs are used as primary or secondary outcomes in clinical trials. Protocols and publications should demonstrate that recruitment was accessible to diverse populations and facilitated by trial design, recruitment strategies, and appropriate PROM usage. The use of translated PROMs should be made explicit when used in cancer clinical trials.

Background Patient-reported outcome measures (PROMs) can provide valuable insights on the impact of a disease or treatment on a patient’s health-related quality of life. In ophthalmology, particularly in dry eye disease (DED) and ocular surface disease (OSD), it is unclear whether the available PROMs were developed using comprehensive guidelines. To address this, we evaluated the methodological quality of studies assessing the psychometric properties of PROMs in DED and OSD [PROSPERO registration number CRD42019142328]. Methods Four databases were searched; reference list and citation searching of included studies was also conducted. The COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist was used to appraise the quality of the studies evaluating the psychometric properties of PROMs used in DED and OSD. Results The search strategy (S3 Table) retrieved 5,761 records, 573 duplicates were removed, 5,188 abstracts were screened and 127 full-text articles were retrieved for further review. Of these, 118 full-text articles did not meet the eligibility criteria and were excluded. Reference list and citation searching, identified an additional 8 articles bringing the total numbers of papers reviewed to 17. In general, psychometric properties such as content validity, measurement error and structural validity were not assessed by the studies included in this review. Studies reviewing The Impact of Dry Eye on Everyday Life (IDEEL) presented with the highest quality scores together with the Ocular Surface Disease Index (OSDI) questionnaire. Conclusions The quality of studies evaluating PROMs in DED and OSD was considered using the COSMIN standards. The majority of the studies evaluating PROMs included in this review did not meet the recommended COSMIN criteria and the quality of the PROMs evaluated is not assured. Further evaluation of their psychometric properties is required if these are going to be used in clinical practice or research.

To (a) identify residual symptoms and deficits resulting from a traumatic brain injury (TBI) and impact on patients' and their families' quality of life; (b) explore views and experience of care providers, researchers, patients, and carers of using PROMs; and (c) explore their attitudes toward reporting symptoms and impacts on an electronic platform. Methods: Qualitative semi-structured interviews with people with TBI and their carers; health-care professionals, researchers, and third sector staff members working with people with TBI. Results: Symptoms and long-term impacts of TBI included cognitive problems, difficulties functioning, anxiety, and depression. PROMs were seen as improving knowledge of residual symptoms and their impact post-TBI but not always accurately reflecting patients' residual problems. Challenges to completing PROMs were cognitive impairment and lack of insight into condition. Perceived advantages of an electronic platform included easy data collection; flexibility; improving workflow; and the ability to send/ receive feedback and reminders easily. Suggested features of an electronic platform included simple layout, lay language, short questions, few items on the screen, and capability to send/receive feedback and additional information. Conclusion: There is a demand for reporting symptoms and their impact electronically, providing the layout is kept simple and feedback from clinicians is provided.

Aims To evaluate the self-perceived preparedness of final year dental undergraduate students in the United Kingdom.Methods Dental undergraduate students in their final year were invited by email through the Dental Schools Council (DSC) to provide their responses to an online preparedness assessment scale. The data analysis was carried out using the RUMM2030 software which is specifically designed for Rasch analysis, a measurement model based on item response theory.Results Students felt adequately prepared to carry out simple clinical procedures and communication skills. However, low scores were reported on ability to assess orthodontic treatment needs, treatment planning, crowns, endodontics, research skills, referral for suspected oral cancer and raising concerns regarding inappropriate behaviour of colleagues.Conclusions The scale used in this study explored the self-perceived preparedness on a range of cognitive, clinical and behavioural attributes. The data show that the students felt prepared for the majority of the attributes expected from dentists. However, a number of areas were identified where students may benefit from further training and consolidation.

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.

Background The numbers of major trauma and traumatic brain injury (TBI) survivors are increasing. Finding efficient ways to capture the impact of symptoms on their quality of life, and optimise patients’ outcomes and clinical shared decision-making is a priority. Patient Reported Outcome Measures (PROMs) are used in healthcare to understand the impact of symptoms on people’s quality of life. Electronic capture of PROM data (e-PROMS) are an efficient way of collecting PROM data and can minimise patients’ burden. Aim This study aims to establish the impact of trauma on patients’ quality of life and to explore views on using e-PROMs to support clinical care and research. Methods In-depth semi-structured one-to-one interviews were conducted with (i) TBI survivors and family members/carers; (ii) healthcare professionals/researchers working in trauma related clinical areas; and (iii) members from third sector organisations who support trauma patients and their families/carers. Results Preliminary results from 19 participants show using PROMs contributed to focus clinical consultations on issues deemed important to patients, including memory loss, anxiety, and lack of concentration. E-PROMS were considered flexible and timesaving and a valuable way of evaluating ongoing symptoms and their impact on quality of life when consulting with clinicians. Patients’ mental health, type of injury, physical impairments, and changes in personality were considered as key features for inclusion in e-PROMs. Over and under-reporting, lack of insight, cognitive and communication problems and lack of internet access, (especially among older patients), were considered barriers to using e-PROMs. Suggested features to facilitate use, included: easy to use, short length, conciseness, and lay language easily understood by trauma patients. Conclusion The electronic capture of PROMs was found to be an acceptable way of reporting patients’ symptoms. Particular attention should be paid to the inclusion of specific measures in future e-PROMs system, such as patients’ ongoing mental health.

Background. Tenancy sustainment—maintenance of a tenancy to avoid a premature end of tenure—is fundamental to prevention of homelessness. Understanding what enables a successful tenancy is essential in informing interventions designed to support people in leaving homelessness. Objectives. To conduct a systematic review identifying determinants associated with tenancy sustainment following homelessness. Search Methods. A detailed search of 12 electronic databases, as well as gray literature sources, was conducted in 2015 and updated in 2016. Selection Criteria. We included all study designs with a population of homeless or formerly homeless individuals in which tenancy sustainment was the primary outcome. Two reviewers independently carried out abstract and full-text reviews. QualSyst, a validated quality appraisal tool, was used in assessing the methodological quality of articles. Data Collection and Analysis. A data extraction form was developed for the review and was completed by a pair of reviewers to ensure accuracy. The heterogeneity of the studies included indicated that a narrative overview of the results was most appropriate. Main Results. Forty-three articles reporting 38 studies were included. Determinants were categorized at 4 levels: individual, interpersonal, community, and structural. Participation in specific programs (e.g., Housing First), receipt of social support, and older age were identified as positive determinants of tenancy sustainment. Conclusions. This systematic review is the first, to our knowledge, to focus solely on tenancy sustainment as a primary outcome. Although a range of determinants associated with tenancy sustainment were identified, it was difficult to draw strong conclusions owing to the heterogeneity of the studies. Despite being a fundamental concept in homelessness research, tenancy sustainment is poorly defined and conceptualized. A deeper understanding of tenancy sustainment will inform the development and evaluation of interventions that support people in leaving homelessness and maintaining tenancies. Public Health Implications. Housing stability is central to preventing homelessness and addressing the numerous public health concerns that can co-occur with homelessness. Our review highlights that a standardized approach to measuring housing stability and more high-quality intervention studies are essential.

Importance Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. Objective To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). Design, Setting, and Participants The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network’s methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. Results The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n = 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed on at a consensus meeting (n = 29 participants) and reviewed by external group of experts during a consultation period. Eleven extensions and 5 elaborations to the SPIRIT 2013 checklist were recommended for inclusion in clinical trial protocols in which PROs are a primary or key secondary outcome. Extension items focused on PRO-specific issues relating to the trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care. Conclusions and Relevance The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.

Aims The aims of this study were to explore the transition of new dental graduates to gain a deeper understanding of the merits and challenges of a mentored year for new graduates in general dental practice settings. Methods The study was conducted in the south-west region of England. Qualitative methods were used to engage a range of stakeholders in dental education including dental students, academics, general dental practitioners, new graduates, specialists and representatives of the postgraduate dental deanery. Purposive sampling was employed, and after ethical approval, participants were contacted through professional channels. All interview transcripts were transcribed verbatim. The data were imported into NVivo 10 (QSR International Pty Ltd) and analysed thematically. Results Sixteen participants representing a variety of stakeholder groups were interviewed. The participants shared their perceptions and experiences regarding the transition new dental graduates into dental practice. The challenges and benefits are discussed along with strategies to facilitate a smooth transition. Conclusions This study provides an insight into experience of a mentored year for new dental graduates in general practice settings. Foundation training provides a structured introduction into general practice and serves as a safety net before new graduates gain further independence in clinical practice.

Objective Multiple sclerosis (MS) is associated with chronic symptoms, including muscle stiffness, spasms, pain and insomnia. Here we report the results of the Multiple Sclerosis and Extract of Cannabis (MUSEC) study that aimed to substantiate the patient based findings of previous studies. Patients and methods Patients with stable MS at 22 UK centres were randomised to oral cannabis extract (CE) (N¼144) or placebo (N¼135), stratified by centre, walking ability and use of antispastic medication. This double blind, placebo controlled, phase III study had a screening period, a 2 week dose titration phase from 5 mg to a maximum of 25 mg of tetrahydrocannabinol daily and a 10 week maintenance phase. The primary outcome measure was a category rating scale (CRS) measuring patient reported change in muscle stiffness from baseline. Further CRSs assessed body pain, spasms and sleep quality. Three validated MS specific patient reported outcome measures assessed aspects of spasticity, physical and psychological impact, and walking ability. Results The rate of relief from muscle stiffness after 12 weeks was almost twice as high with CE than with placebo (29.4% vs 15.7%; OR 2.26; 95% CI 1.24 to 4.13; p¼0.004, one sided). Similar results were found after 4 weeks and 8 weeks, and also for all further CRSs. Results from the MS scales supported these findings. Conclusion The study met its primary objective to demonstrate the superiority of CE over placebo in the treatment of muscle stiffness in MS. This was supported by results for secondary efficacy variables. Adverse events in participants treated with CE were consistent with the known side effects of cannabinoids. No new safety concerns were observed. Trial registration number NCT00552604.

Introduction: In response to growing interest in leisure in occupational therapy and the importance of understanding how occupations maintain, enhance and promote health and wellbeing, a qualitative phenomenological study was conducted to explore the experiences of walking for leisure. Method: Six healthy student participants, identified as regular walkers, were interviewed using a semi-structured format. Data were analysed following interpretative phenomenological analysis methodology. Findings: Participants expressed how and why walking was meaningful to them; the four main themes were social connectedness, wellbeing, connection to nature and achievement from a challenge. Findings suggest that occupational therapists could use walking and leisure occupations in intervention, and that there is scope for an occupational therapy perspective in health promotion. Conclusion: Determining the subjective meaning of engaging in walking as a leisure occupation has implications for occupational science and health promotion in helping to explain why people do what they do.

Objective: To analyse cross-cultural validity of the Functional Independence Measure (FIM) in patients with stroke using the Rasch model. Settings: Thirty-one rehabilitation facilities within 6 different countries in Europe. Participants: A total of 2546 in-patients at admission, median age 63 years. Methods: Data from the FIM were evaluated with the Rasch model, using the Rasch analysis package RUMM2020. A detailed analysis of scoring functions of the 7 categories of the FIM items was undertaken prior to testing fit to the model. Categories were re-scored where necessary. Analysis of Differential Item Functioning was undertaken in pooled data for each of the FIM motor and social-cognitive scales, respectively. Results: Disordered thresholds were found on most items when using 7 categories. Fit to the Rasch model varied between countries. Differential Item Functioning was found by country for most items. Adequate fit to the Rasch model was achieved when items were treated as unique for each country and after a few country-specific items were removed. Conclusion: Clinical collected data from FIM for patients with stroke cannot be pooled in its raw form, or compared across countries. Comparisons can be made after adjusting for country-specific Differential Item Functioning, though the adjustments for Differential Item Functioning and rating scales may not generalize to other samples.

Discharge from hospital to a nursing home represents a major event in the life of an older person and should follow the most comprehensive functional and medical assessment. This article aimed to identify factors that influence placement and specifically test which widely used standardized instruments of health status may be useful in an assessment. A cohort study was undertaken of 549 patients admitted to three acute ‘medicine for the elderly’ wards in an NHS Trust in Northern England. Outcome measures were a variety of health status measures in current use. Results showed that baseline assessment using generic self-completed measures of health status failed to predict future placement. However, four measures used routinely within a clinical setting – the Northwick Park Dependency Scale, the Abbreviated Mental Test Score, the Modified Barthel Index and the Caregiver Strain Index – did discriminate across outcomes.

A health needs assessment of people with multiple sclerosis (MS) in Leeds identified the need for information as a priority. An information pack was developed using focus groups and individual interviews undertaken with people with MS, carers and health-care professionals. A second group of people with MS participated in a 6-month evaluation, recording symptoms, quality of life and health status at baseline and follow-up. Usage of the information pack and its suitability was recorded. Fatigue and muscle stiffness were the most commonly reported symptoms (79%). Although quality of life was relatively good at baseline, the progressive group became worse (P

Aims The aims of this study were to articulate the concept of preparedness of dental graduates for foundation training programme in the United Kingdom and identify the essential attributes of preparedness. Methods A qualitative approach using semi-structured interviews was used to explore the concept of preparedness. The study was carried out in the South West region of England. Participants were recruited from a range of stakeholders in dental education and foundation training using purposive sampling. Participants were recruited using email through appropriate professional channels. Stakeholders included dental students (DS), dental academics (DA), foundation dental practitioners (FDP), foundation trainers (FT), general dental practitioners (GDP) and a postgraduate dental deanery representative (DDR). Interviews were transcribed verbatim and data were imported into NVivo 9 and analysed thematically. Results Sixteen interviews were carried out with representation from all stakeholder groups. Participants expressed their views on a range of issues related to the preparedness of dental graduates. Conclusions This study provides useful insights into the concept of preparedness as perceived by the stakeholders. The findings of this study may offer clarity on the essential attributes required by dental graduates upon entry into foundation training.

Background and objectives: Determining responsiveness of measures across different samples and settings is important for selecting measures of mobility and understanding multiple sclerosis (MS) study results. Currently such information is limited. Methods: This exploratory study examined the relative responsiveness of four mobility measures (walking velocity, 6-minute walk distance, Rivermead Mobility Index and MS Walking Scale) in a community sample ( n = 70), after three annual assessments. Distribution based estimates and anchor-based methods (comparison against transition questions) determined responsiveness. A head-to-head comparison was made. Results: While variations in individuals occurred, the group mean change scores for all measures was small, suggesting that there was minimal deterioration in the total sample. Consistent with this, total sample Effect Size (ES) was negligible to small (ES −0.32 to +0.03) for all measures. Differentiation between sub-groups, defined by the participants’ perception of change in mobility over the past year (transition questions), showed that some instruments could detect clinically significant changes (small sample sizes limited this interpretation). Correlation analyses between change scores demonstrated that these measures captured related, but different information ( r < 0.364). Conclusions: The measures were broadly comparable in detecting mobility changes in this community sample. These correlations highlight that in selection of measures, one should also consider the discrete mobility dimension that the intervention intends to impact.

Purpose of the study This qualitative study explored Slovenian older people's experiences of transition into a care home and the influence on their everyday engagement in meaningful occupations. Design and methods A longitudinal, phenomenological approach was employed. Semistructured interviews with six Slovenian older adults were conducted at three time intervals: before the relocation, 1 month after, and 6 months after the relocation into a care home. Interpretative Phenomenological Analysis was used for the study design and analysis. Results One overarching theme from the research findings Holding on to what I do is presented in depth. Although the participants' everyday occupations were challenged throughout the transition, they tried to maintain their most meaningful occupations that were an important part of their identity. Three superordinate themes underpinned this overarching theme: This is who I am, Adjusting my daily occupations, and The value of health. Implications The study indicated the need to develop programs and services for older adults transitioning from home into a care home environment. Focusing on enabling older people to maintain their engagement in meaningful occupations as an important part of their identity is imperative. This study brings a better understanding of older people's experiences of transition into a care home from an occupational perspective. It has the potential to influence how elder care is planned and implemented in Slovenia and further afield.

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.

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 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 proper ties of the composite UL-MAS score in this clinical population.

To analyse cross-culture validity of the Functional Independence Measure (FIM) in patients with a spinal cord injury using a modern psychometric approach.A total of 19 rehabilitation facilities from four countries in Europe.A total of 647 patients at admission, median age 46 years, 69% male.Data from the FIM, collected on inpatient admission, was fitted to the Rasch model. A detailed analysis of scoring functions of the seven categories of the FIM items was undertaken before to testing fit to the model. Categories were rescored where necessary. Fit to the model was assessed initially within country, and then in the pooled data. Analysis of differential item functioning (DIF) was undertaken in the pooled data for each of the FIM motor and social cognitive scales, respectively. Final fit to the model was tested for breach of local independence by principle components analysis (PCA).The present scoring system for the FIM motor and cognitive scales, that is a seven category scale, was found to be invalid, necessitating extensive rescoring. Following this, DIF was found in a number of items within the motor scale, requiring a complex solution of splitting items by country to allow for the valid pooling of data. Five country-specific items could not be retained within this solution. The FIM cognitive scale fitted the Rasch model after rescoring, but there was a substantial ceiling effect.Data from the FIM motor scale for patients with spinal cord injury should not be pooled in its raw form, or compared from country to country. Only after fit to the Rasch model and necessary adjustments could such a comparison be made, but with a loss of clinical important items. The FIM cognitive scale works well following rescoring, and data may be pooled, but many patients were at the maximum score.

Objective To develop a new foot impact scale to assess foot status in rheumatoid arthritis (RA) using established qualitative methodology and the latest item response techniques (Rasch analysis). Methods Foot problems in RA were explored by conducting qualitative interviews that were then used to generate items for a new foot impact scale. Further validation was undertaken following postal surveys and Rasch analysis. Results Analysis of the first postal survey (n = 192 responses) produced a 63-item binary response, 4-subscale instrument. The 4 subscales covered the domains impairment, activities, participation, and footwear. Following test–retest postal surveys and additional analysis, the instrument was reduced to a 2 subscale, 51-item questionnaire covering the domains of impairments/shoes and activities/participation. Initial results of these subscales indicate good psychometric properties, external validity, and test–retest reliability. Conclusion A foot impact scale to assess the impact of RA and to measure the effect of interventions has been developed. The 2 scales comprising the instrument demonstrate good psychometric properties.

A randomised single-blind controlled trial was designed to determine whether intensity of therapy (physiotherapy and occupational therapy) shortened length of stay for patients in a rehabilitation unit. Patients were under 65, primarily with stroke, but also with other conditions such as traumatic brain injury, and multiple sclerosis. The experimental group were timetabled to receive 67% more therapy in any given week, than the control group. After controlling for confounders and case mix (as expressed by type of therapy required) patients in the experimental group showed a significant 14-day reduction in length of stay (

The aim of this study was to explore the perceptions of stakeholders regarding a newly established dental school with a problem-based, student-led, patient-centered curriculum in a community setting. Qualitative methods using 16 semistructured interviews and two focus groups were used to engage a range of stakeholders from students to faculty members to practitioners. Purposive sampling was employed with participants contacted through professional channels. Interview and focus group transcripts were transcribed verbatim. The data were analyzed thematically using an inductive approach. Themes related to preparedness of dental graduates were identified during data analyses. Early clinical exposure with patients in the first year of the course, holistic care using a patient-centered approach, and the acquisition of communication skills, professionalism, team-working skills, reflective practice, and evidence-informed clinical practice were perceived to be key strengths of the curriculum. The participants also expressed the need to strengthen teaching of life sciences and provide additional clinical experience in simulated general dental practice clinics. This study provides insight into the perceptions of a wide range of stakeholders and provides a deeper understanding of the merits and challenges of an innovative undergraduate dental curriculum.