Creating a Digital Toolkit to Reduce Fatigue and Promote Quality of Life in Multiple Sclerosis: Participatory Design and Usability Study.

BACKGROUND: Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS), experienced by more than 80% of people with MS. FACETS (Fatigue: Applying Cognitive Behavioral and Energy Effectiveness Techniques to Lifestyle) is an evidence-based, face-to-face, 6-session group fatigue management program for people with MS. Homework tasks are an integral part of FACETS and are currently undertaken in a paper-based form. Feedback from a consultation undertaken with FACETS attendees and health care professionals with experience in delivering the FACETS program suggested that being able to complete the homework tasks digitally would be desirable, potentially enhancing engagement and adherence and enabling on-the-go access to fit into busy lifestyles. Relative to other long-term conditions, there are few apps specifically for MS and, of those available, many have been developed with little or no input from people with MS. OBJECTIVE: The purpose of this mixed methods study was to create a digital toolkit comprising the homework tasks (eg, activity diary, goal planner, thought diary) of the FACETS program for people with MS, considering end users' unique requirements throughout the design, build, prototyping, and testing stages. METHODS: Phase 1 involved the elicitation of detailed user requirements for the toolkit via 2 focus groups with previous attendees of FACETS (n=3 and n=6) and wireframing. Phase 2 involved supervised usability testing with people with MS (n=11) with iterative prototyping. The usability sessions involved going through test scenarios using the FACETS toolkit on an Android test phone with video capture and concurrent think-aloud followed by completion of the System Usability Scale (SUS) and a semistructured interview collecting feedback about design, content, and functionality. RESULTS: The mean SUS score for the digital toolkit was 74.3 (SD 16.8, 95% CI 63.2-85.6; range 37.5-95), which equates to an adjective rating of good and a B grade (70th-79th percentile range) on the Sauro-Lewis curved grading scale. A number of usability and design issues (such as simplifying overall screen flow to better meet users' needs) and suggestions for improvements (such as using location-based services and displaying personalized information and progress via a central dashboard) were addressed and implemented during the usability testing cycle. CONCLUSIONS: This work highlights the importance of the participation of people with MS across the entire development cycle, working to a human-centered design methodology to enable a considered and MS-centered solution to be developed. Continued horizon scanning for emergent technological enhancements will enable us to identify opportunities for further improvements to the FACETS toolkit prior to launch. The toolkit supports self-monitoring and management of fatigue and has potential applicability to other long-term conditions where fatigue is a significant issue.

The effectiveness of peroneal nerve functional electrical simulation for the reduction of bradykinesia in Parkinson's disease: A feasibility study for a randomised control trial.

OBJECTIVES: To assess the feasibility of a multi-site randomised controlled trial to evaluate the effect of functional electrical stimulation on bradykinesia in people with Parkinson's disease. DESIGN: A two-arm assessor blinded randomised controlled trial with an 18 weeks intervention period and 4 weeks post-intervention follow-up. SETTING: Two UK hospitals; a therapy outpatient department in a district general hospital and a specialist neuroscience centre. PARTICIPANTS: A total of 64 participants with idiopathic Parkinson's disease and slow gait <1.25 ms-1. INTERVENTIONS: Functional electrical stimulation delivered to the common peroneal nerve while walking in addition to standard care compared with standard care alone. MAIN MEASURES: Feasibility aims included the determination of sample size, recruitment and retention rates, acceptability of the protocol and confirmation of the primary outcome measure. The outcome measures were 10 m walking speed, Unified Parkinson's Disease Rating Scale (UPDRS), Mini Balance Evaluation Systems Test, Parkinson's Disease Questionnaire-39, EuroQol 5-dimension 5-level, New Freezing of Gait questionnaire, Falls Efficacy Score International and falls diary. Participants opinion on the study design and relevance of outcome measures were evaluated using an embedded qualitative study. RESULTS: There was a mean difference between groups of 0.14 ms-1 (CI 0.03, 0.26) at week 18 in favour of the treatment group, which was maintained at week 22, 0.10 ms-1 (CI -0.05, 0.25). There was a mean difference in UPDRS motor examination score of -3.65 (CI -4.35, 0.54) at week 18 which was lost at week 22 -0.91 (CI -2.19, 2.26). CONCLUSION: The study design and intervention were feasible and supportive for a definitive trial. While both the study protocol and intervention were acceptable, recommendations for modifications are made.

Design considerations for a multiple sclerosis fatigue mobile app MS Energize: A pragmatic iterative approach using usability testing and resonance checks.

Multiple sclerosis (MS) is a chronic neurological condition affecting around 2.2 million people worldwide. The illness includes a range of symptoms, with fatigue considered to be one of the most disabling. This paper describes how a pragmatic and iterative approach, supported by usability and resonance testing, was used to build a minimum viable product of MS Energize-or MS Energise in UK English regions. MS Energise is a mobile application focused on self-management of fatigue for people with MS. The iterative approach included various stages of testing, during which user feedback including comments about interface, navigation and content, was sought to inform incremental app development and continual improvement. Usability testing was conducted with 11 people with longstanding multiple sclerosis in New Zealand and the United Kingdom, and focused on particular sections of the app as well as the accessibility of the app to users with MS. Two participants contributed to further resonance testing post-release to ensure the app was perceived as relevant and useful to the user. The usability testing and resonance testing phases suggested that user experience of MS Energise was mostly positive. Participants provided a number of suggestions for improvements to aspects of content and design; some of which we implemented during our app development process. Findings will also contribute to future planning and design iteration to enhance the user experience. The next step is further improvement of MS Energise prior to a trial of its clinical and cost effectiveness.

Digital Health Rehabilitation Can Improve Access to Care in Spinal Cord Injury in the UK: A Proposed Solution.

Lack of specialist beds, inadequate finance and shortage of skilled staff make it difficult for Spinal Cord Injury Centres (SCICs) in the United Kingdom (UK) to admit all newly injured individuals. Length of stay of those admitted can be too brief. At discharge, follow-up care is sparse and inadequate. We therefore propose that specialist spinal units redefine their roles and act as catalysts to build capacity by enhancing expertise in the wider community. SCICs can devolve certain tasks locally to less specialised units with their support, training, and guidance. This Commentary further proposes that use of Digital Health Technologies, (i.e., to deploy telemedicine, telehealth, and telerehabilitation), can enhance rehabilitation opportunities. The authors set-forth their vision for a comprehensive web portal that will serve as a primary resource for evidence-based practice, information on guidelines, care pathways, and protocols of SCI management. At any stage during the acute management of SCI and following discharge, rehabilitation specialists could conduct remote consultation with persons with SCI and acute care specialists via the web portal, allowing timely access to specialist input and better clinical outcomes. The proposed portal would also provide information, advice and support to persons with SCI and their family members. The strategic use of digital health technologies has been shown to result in cost and time savings and increase positive outcomes.

Feasibility and Accuracy of Different Methods for Collecting Data on Falls Among Older People With Dementia.

This study compared different methods for collecting data on falls among people with dementia to identify which is most feasible and accurate. Eighty-three dyads, comprised of a community-dwelling person with dementia and their informal carer, participated in the TAi ChI for people with demenTia (TACIT) trial. Falls were collected prospectively over 6 months using monthly calendars, weekly and monthly telephone interviews, and 3-monthly telephone interviews with the carer. Unique falls identified across the reporting methods were combined, and this total was compared against each reporting method in isolation and combinations. A higher frequency of falls indicated greater accuracy. Falls data collection was most feasible with weekly telephone interviews (84%), and most accurate with the combination of weekly telephone interviews with monthly calendars (96%). For the greatest completeness and accuracy of falls data with community-dwelling people with dementia, researchers should use both weekly telephone interviews and monthly calendars.

Randomised Controlled Trial Of The Effect Of Tai Chi On Postural Balance Of People With Dementia.

PURPOSE: To investigate the effect of Tai Chi exercise on postural balance among people with dementia (PWD) and the feasibility of a definitive trial on falls prevention. PATIENTS AND METHODS: Dyads, comprising community-dwelling PWD and their informal carer (N=85), were randomised to usual care (n=43) or usual care plus weekly Tai Chi classes and home practice for 20 weeks (n=42). The primary outcome was the timed up and go test. All outcomes for PWD and their carers were assessed six months post-baseline, except for falls, which were collected prospectively over the six-month follow-up period. RESULTS: For PWD, there was no significant difference at follow-up on the timed up and go test (mean difference [MD] = 0.82, 95% confidence interval [CI] = -2.17, 3.81). At follow-up, PWD in the Tai Chi group had significantly higher quality of life (MD = 0.051, 95% CI = 0.002, 0.100, standardised effect size [ES] = 0.51) and a significantly lower rate of falls (rate ratio = 0.35, 95% CI =0.15, 0.81), which was no longer significant when an outlier was removed. Carers in the Tai Chi group at follow-up were significantly worse on the timed up and go test (MD = 1.83, 95% CI = 0.12, 3.53, ES = 0.61). The remaining secondary outcomes were not significant. No serious adverse events were related to participation in Tai Chi. CONCLUSION: With refinement, this Tai Chi intervention has potential to reduce the incidence of falls and improve quality of life among community-dwelling PWD [Trial registration: NCT02864056].

HeART of Stroke: randomised controlled, parallel-arm, feasibility study of a community-based arts and health intervention plus usual care compared with usual care to increase psychological well-being in people following a stroke.

INTRODUCTION: People often experience distress following stroke due to fundamental challenges to their identity. OBJECTIVES: To evaluate (1) the acceptability of 'HeART of Stroke' (HoS), a community-based arts and health group intervention, to increase psychological well-being; and (2) the feasibility of a definitive randomised controlled trial (RCT). DESIGN: Two-centre, 24-month, parallel-arm RCT with qualitative and economic components. Randomisation was stratified by centre and stroke severity. Participant blinding was not possible. Outcome assessment blinding was attempted. SETTING: Community. PARTICIPANTS: Community-dwelling adults ≤2 years poststroke recruited via hospital clinical teams/databases or community stroke/rehabilitation teams. INTERVENTIONS: Artist-facilitated arts and health group intervention (HoS) (ten 2-hour sessions over 14 weeks) plus usual care (UC) versus UC. OUTCOMES: The outcomes were self-reported measures of well-being, mood, capability, health-related quality of life, self-esteem and self-concept (baseline and 5 months postrandomisation). Key feasibility parameters were gathered, data collection methods were piloted, and participant interviews (n=24) explored the acceptability of the intervention and study processes. RESULTS: Despite a low recruitment rate (14%; 95% CI 11% to 18%), 88% of the recruitment target was met, with 29 participants randomised to HoS and 27 to UC (57% male; mean (SD) age=70 (12.1) years; time since stroke=9 (6.1) months). Follow-up data were available for 47 of 56 (84%; 95% CI 72% to 91%). Completion rates for a study-specific resource use questionnaire were 79% and 68% (National Health Service and societal perspectives). Five people declined HoS postrandomisation; of the remaining 24 who attended, 83% attended ≥6 sessions. Preliminary effect sizes for candidate primary outcomes were in the direction of benefit for the HoS arm. Participants found study processes acceptable. The intervention cost an estimated £456 per person and was well-received (no intervention-related serious adverse events were reported). CONCLUSIONS: Findings from this first community-based study of an arts and health intervention for people poststroke suggest a definitive RCT is feasible. Recruitment methods will be revised. TRIAL REGISTRATION NUMBER: ISRCTN99728983.

First Do No Harm: An Opinion on Bundled Care for Stroke Patients.

The Center for Medicare and Medicaid Innovation under the Centers for Medicare and Medicaid Services has invited institutions to demonstrate ways to bundle services into a 90-day episode of acute care that will lower costs and hospital re-admission rates. While these goals are laudable, they overlook the need for and value attained in postacute treatment. This article argues for elimination of the diagnosis of stroke from the proposed demonstration project due to misaligned financial incentives that will severely compromise patient outcomes.

Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii) to increase activity levels, vitality and well-being in people with multiple sclerosis.

OBJECTIVES: While the health and well-being benefits of physical activity are recognised, people with multiple sclerosis (MS) often face greater barriers than the general population. The Nintendo Wii potentially offers a fun, convenient way of overcoming some of these. The aim was to test the feasibility of conducting a definitive trial of the effectiveness and cost-effectiveness of Mii-vitaliSe; a home-based, physiotherapist-supported Nintendo Wii intervention. DESIGN: A single-centre wait-list randomised controlled study. SETTING: MS service in secondary care. PARTICIPANTS: Ambulatory, relatively inactive people with clinically confirmed MS. INTERVENTION: Thirty participants were randomised to receive Mii-vitaliSe either immediately (for 12 months) or after a 6-month wait (for 6 months). Mii-vitaliSe consisted of two supervised Nintendo Wii familiarisation sessions in the hospital followed by home use (Wii Sports, Sports Resort and Fit Plus software) with physiotherapist support and personalised resources. OUTCOMES: Included self-reported physical activity levels, quality of life, mood, self-efficacy, fatigue and assessments of balance, gait, mobility and hand dexterity at baseline, 6 and 12 months. Interviews (n=25) explored participants' experiences and, at study end, the two Mii-vitaliSe facilitators' experiences of intervention delivery (main qualitative findings reported separately). RESULTS: Mean (SD) age was 49.3 (8.7) years, 90% female, with 47% diagnosed with MS <6 years ago and 60% new to active gaming. The recruitment rate was 31% (95% CI 20% to 44%). Outcome data were available for 29 (97%) at 6 months and 28 (93%) at 12 months. No serious adverse events were reported during the study. Qualitative data indicated that Mii-vitaliSe was well-received. Mean Wii use across both groups over the initial 6-month intervention period was twice a week for 27 min/day. Mean cost of delivering Mii-vitaliSe was £684 per person. DISCUSSION: Mii-vitaliSe appears acceptable and a future trial feasible and warranted. These findings will inform its design. TRIAL REGISTRATION: ISRCTN49286846.

MotivATE: A Pretreatment Web-Based Program to Improve Attendance at UK Outpatient Services Among Adults With Eating Disorders.

BACKGROUND: In the UK, eating disorders affect upward of 725,000 people per year, and early assessment and treatment are important for patient outcomes. Around a third of adult outpatients in the UK who are referred to specialist eating disorder services do not attend, which could be related to patient factors related to ambivalence, fear, and a lack of confidence about change. This lack of engagement has a negative impact on the quality of life of patients and has implications for service costs. OBJECTIVE: To describe the development of a Web-based program ("MotivATE") designed for delivery at the point of referral to an eating disorder service, with the aim of increasing service attendance. METHODS: We used intervention mapping and a person-based approach to design the MotivATE program and conducted a needs assessment to determine the current impact of service nonattendance on patients (via a review of the qualitative evidence) and services (through a service provision survey to understand current issues in UK services). Following the needs assessment, we followed the five steps of program development outlined by Bartholomew et al (1998): (1) creating a matrix of proximal program objectives; (2) selecting theory-based intervention methods and strategies; (3) designing and organizing the program; (4) specifying adoption and implementation plans; and (5) generating program evaluation plans. RESULTS: The needs assessment identified current nonattendance rates of 10%-32%. We defined the objective of MotivATE as increasing attendance rates at an eating disorder service and considered four key determinants of poor attendance: patient ambivalence about change, low patient self-efficacy, recognition of the need to change, and expectations about assessment. We chose aspects of motivational interviewing, self-determination theory, and the use of patient stories as the most appropriate ways to enable change. Think-aloud piloting with people with lived experience of an eating disorder resulted in positive feedback on the MotivATE program. Participants related well to the stories used. Nonetheless, because of feedback, we further modified the program in line with patients' stage of change and addressed issues with the language used. A consultation with service staff meant that we could make clear implementation plans. Finally, a randomized controlled trial is currently underway to evaluate the MotivATE program. CONCLUSIONS: Using intervention mapping, we have developed a novel pretreatment Web-based program that is acceptable to people with eating disorders. To our knowledge, this is the first such program. The model of development described here could be a useful template for designing further programs for other difficult-to-engage populations.

Anxiety, emotional processing and depression in people with multiple sclerosis.

BACKGROUND: Despite the high comorbidity of anxiety and depression in people with multiple sclerosis (MS), little is known about their inter-relationships. Both involve emotional perturbations and the way in which emotions are processed is likely central to both. The aim of the current study was to explore relationships between the domains of mood, emotional processing and coping and to analyse how anxiety affects coping, emotional processing, emotional balance and depression in people with MS. METHODS: A cross-sectional questionnaire study involving 189 people with MS with a confirmed diagnosis of MS recruited from three French hospitals. Study participants completed a battery of questionnaires encompassing the following domains: i. anxiety and depression (Hospital Anxiety and Depression Scale (HADS)); ii. emotional processing (Emotional Processing Scale (EPS-25)); iii. positive and negative emotions (Positive and Negative Emotionality Scale (EPN-31)); iv. alexithymia (Bermond-Vorst Alexithymia Questionnaire) and v. coping (Coping with Health Injuries and Problems-Neuro (CHIP-Neuro) questionnaire. Relationships between these domains were explored using path analysis. RESULTS: Anxiety was a strong predictor of depression, in both a direct and indirect way, and our model explained 48% of the variance of depression. Gender and functional status (measured by the Expanded Disability Status Scale) played a modest role. Non-depressed people with MS reported high levels of negative emotions and low levels of positive emotions. Anxiety also had an indirect impact on depression via one of the subscales of the Emotional Processing Scale ("Unregulated Emotion") and via negative emotions (EPN-31). CONCLUSIONS: This research confirms that anxiety is a vulnerability factor for depression via both direct and indirect pathways. Anxiety symptoms should therefore be assessed systematically and treated in order to lessen the likelihood of depression symptoms.

'HeART of Stroke (HoS)', a community-based Arts for Health group intervention to support self-confidence and psychological well-being following a stroke: protocol for a randomised controlled feasibility study.

INTRODUCTION: Over 152,000 people in the UK have strokes annually and a third experience residual disability. Low mood also affects a third of stroke survivors; yet psychological support is poor. While Arts for Health interventions have been shown to improve well-being in people with mild-to-moderate depression post-stroke, their role in helping people regain sense of self, well-being and confidence has yet to be evaluated. The main aim of this study is to explore the feasibility of conducting a pragmatic multicentre randomised controlled trial to assess the effectiveness and cost-effectiveness of an Arts for Health group intervention ('HeART of Stroke' (HoS)) for stroke survivors. HoS is a 10-session artist-facilitated group intervention held in the community over 14 weeks. It offers a non-judgemental, supportive environment for people to explore sense of self, potentially enhancing well-being and confidence. METHODS AND ANALYSIS: Sixty-four people, up to 2 years post-stroke, recruited via secondary care research staff or community stroke/rehabilitation teams in two UK centres will be randomised to either HoS plus usual care or usual care only. Self-reported outcomes, measured at baseline and approximately 5 months postrandomisation, will include stroke-related, well-being, mood, self-esteem, quality of life and process measures. Analyses will focus on estimating key feasibility parameters (eg, rates of recruitment, retention, intervention attendance). We will develop outcome and resource use data collection methods to inform an effectiveness and cost-effectiveness analysis in the future trial. Interviews, with a sample of participants, will explore the acceptability of the intervention and study processes, as well as experiences of the HoS group. ETHICS AND DISSEMINATION: National Health Service (NHS), Research and Development and University ethical approvals have been obtained. Two peer-reviewed journal publications are planned plus one service user led publication. Findings will be disseminated at key national conferences, local stakeholder events and via institutional websites. TRIAL REGISTRATION NUMBER: ISRCTN99728983.

The Multiple Sclerosis-Fatigue Self- Efficacy (MS-FSE) scale: initial validation.

OBJECTIVE: To examine the validity and sensitivity to change of the Multiple Sclerosis-Fatigue Self-Efficacy scale. DESIGN: A validation study nested within a randomized controlled trial. SETTING: Community setting. PARTICIPANTS: Adults with a clinically definite diagnosis of multiple sclerosis and significant fatigue taking part in a randomized controlled trial evaluating a group-based fatigue management programme (FACETS) for people with multiple sclerosis (N=164). MAIN MEASURES: The 9-item Multiple Sclerosis-Fatigue Self-Efficacy scale was completed at baseline, 1-, 4- and 12 months post intervention. Validity, internal consistency and sensitivity to change were examined using classical test theory and Rasch analysis. RESULTS: Item 3 was unanswered by 6% of respondents as they did not know any other people with multiple sclerosis; remaining analyses were carried out with this item deleted. All response choices were utilised, no floor or ceiling effects were evident and there were few missing responses. Cronbach's alphas were high (baseline, 0.89; follow-up 1, 0.93; follow-up 2, 0.94; follow-up 3, 0.90). The Multiple Sclerosis-Fatigue Self-Efficacy scale (8-item) demonstrated good sensitivity to change following attendance of the FACETS programme (within participant effect sizes 0.66 and 0.69 and 0.54 at 1, 4, and 12 months follow-up). Principal Components Analysis yielded one component. In the Rasch analysis two items with disordered thresholds were rescored. Item 8 displayed differential item functioning by disability and was combined into a testlet with item 4, resulting in a unidimensional scale. The sample was well targeted to the scale. CONCLUSION: At a scale level the Multiple Sclerosis-Fatigue Self-Efficacy scale is internally valid and has good sensitivity to change.

One year follow-up of a pragmatic multi-centre randomised controlled trial of a group-based fatigue management programme (FACETS) for people with multiple sclerosis.

BACKGROUND: Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS). The aim was to evaluate the effectiveness at 1-year follow-up of a manualised group-based programme ('FACETS') for managing MS-fatigue. METHODS: One-year follow-up of a pragmatic multi-centre randomised controlled trial. People with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcome measures were fatigue severity (Global Fatigue Severity subscale of the Fatigue Assessment Instrument), self-efficacy (MS-Fatigue Self-Efficacy) and disease-specific quality of life (MS Impact Scale). RESULTS: Between May 2008 and November 2009, 164 participants were randomised. Primary outcome data were available at 1 year for 131 (80%). The benefits demonstrated at 4-months in the FACETS arm for fatigue severity and self-efficacy largely persisted, with a slight reduction in standardised effect sizes (SES) (-0.29, p = 0.06 and 0.34, p = 0.09, respectively). There was a significant difference on the MS Impact Scale favouring FACETS that had not been present at 4-months (SES -0.24, p = 0.046). No adverse events were reported. CONCLUSIONS: Improvements in fatigue severity and self-efficacy at 4-months follow-up following attendance of FACETS were mostly sustained at 1 year with additional improvements in MS impact. The FACETS programme provides modest long-term benefits to people with MS-fatigue. TRIAL REGISTRATION: ISRCTN76517470.

Testing the feasibility and acceptability of using the Nintendo Wii in the home to increase activity levels, vitality and well-being in people with multiple sclerosis (Mii-vitaliSe): protocol for a pilot randomised controlled study.

INTRODUCTION: The benefits of physical activity for people with multiple sclerosis (pwMS) have been recognised. However, exercise regimens can be difficult to maintain over the longer term and pwMS may face unique barriers to physical activity engagement. Pilot research suggests the Nintendo Wii can be used safely at home by pwMS with minimal mobility/balance issues and may confer benefits. We have developed a home-based physiotherapist supported Wii intervention ('Mii-vitaliSe') for pwMS that uses commercial software. This is a pilot study to explore the feasibility of conducting a full scale clinical and cost-effectiveness trial of Mii-vitaliSe. METHODS AND ANALYSIS: 30 ambulatory, relatively inactive pwMS will be randomised to receive Mii-vitaliSe immediately, or after 6 months. Outcomes, measured at baseline and 6 and 12 months later, will include balance, gait, mobility, hand dexterity and self-reported physical activity levels, fatigue, self-efficacy, mood and quality of life. Interviews conducted on a purposive sample of participants will explore experiences of participation in the study and barriers and facilitators to using the Wii. Mean recruitment, adherence rate and standard deviations (SDs) of potential primary outcomes for the full trial will be estimated and precision summarised using 95% confidence intervals (CIs). Interview transcripts will be thematically analysed using a generic qualitative approach. ETHICS AND DISSEMINATION: National Health Service (NHS; ref 12/SC/0420) and university ethical approvals have been obtained as has NHS Research and Development permission from the relevant trust. A home risk assessment will be undertaken for all potential participants. All adverse events will be closely monitored, documented and reported to the study Safety Monitoring Committee. At least one publication in a peer reviewed journal will be produced and research findings presented at a national and international conference. With service users, we will coproduce a summary of the findings for dissemination on our research unit's website and elsewhere. TRIAL REGISTRATION NUMBER: ISRCTN 49286846.

Proportional lumbar spine inter-vertebral motion patterns: a comparison of patients with chronic, non-specific low back pain and healthy controls.

INTRODUCTION: Identifying biomechanical subgroups in chronic, non-specific low back pain (CNSLBP) populations from inter-vertebral displacements has proven elusive. Quantitative fluoroscopy (QF) has excellent repeatability and provides continuous standardised inter-vertebral kinematic data from fluoroscopic sequences allowing assessment of mid-range motion. The aim of this study was to determine whether proportional continuous IV rotational patterns were different in patients and controls. A secondary aim was to update the repeatability of QF measurement of range of motion (RoM) for inter-vertebral (IV) rotation. METHODS AND MATERIALS: Fluoroscopic sequences were recorded of passive, recumbent coronal and sagittal motion, which was controlled for range and velocity. Segments L2-5 in 40 primary care CNSLBP patients and 40 matched controls were compared. Patients also completed the von Korff Chronic Pain Grade and Roland and Morris Disability Questionnaire. Sequences were processed using automated image tracking algorithms to extract continuous inter-vertebral rotation data. These were converted to continuous proportional ranges of rotation (PR). The continuous proportional range variances were calculated for each direction and combined to produce a single variable representing their fluctuation (CPRV). Inter- and intra-rater repeatability were also calculated for the maximum IV-RoM measurements obtained during controlled trunk motion to provide an updated indication of the reliability and agreement of QF for measuring spine kinematics. RESULTS: CPRV was significantly higher in patients (0.011 vs. 0.008, Mann-Whitney two-sided p = 0.008), implying a mechanical subgroup. Receiver operating characteristic curve analysis found its sensitivity and specificity to be 0.78 % (60-90) and 0.55 % (37-73), respectively (area under the curve 0.672). CPRV was not correlated with pain severity or disability. The repeatability of maximum inter-vertebral range was excellent, but range was only significantly greater in patients at L4-5 in right side bending (p = 0.03). CONCLUSION: The variation in proportional motion between lumbar vertebrae during passive recumbent trunk motion was greater in patients with CNSLBP than in matched healthy controls, indicating that biomechanical factors in passive structures play a part.

Clinical risk factors for underlying gastrointestinal malignancy in iron deficiency anaemia: the IDIOM study.

OBJECTIVE: Ten percent of adults presenting with iron deficiency anaemia (IDA) have underlying cancer. This analysis - the Iron Deficiency as an Indicator Of Malignancy (IDIOM) study - was undertaken to assess whether five simple clinical parameters can usefully predict the likelihood of gastrointestinal (GI) malignancy on subsequent investigation of patients with IDA. DESIGN: Retrospective observational study, with multivariable analysis of the predictive value of sex, age, haemoglobin concentration (Hb), mean red cell volume (MCV) and iron studies for the risk of underlying GI malignancy. SETTING: District General Hospital IDA clinic. PATIENTS: 720 adults with confirmed IDA. RESULTS: Sex, age and Hb were strongly associated with the risk of GI malignancy-the parsimonious model including only these variables yielded ORs of 4.0 (95% CI 2.3 to 7.0) for males compared with females; 3.3 (95% CI 1.7 to 6.4) for age >70 years compared with ≤70 years; and 5.3 (95% CI 2.4 to 11.7) for a Hb of ≤91.4 g/L compared with ≥111.5 g/L. Combining these risk factors identified a subgroup (12% of the study population) at particularly low risk (<2% likelihood), and a second subgroup (16% of the study population) at especially high risk (>20% likelihood) of underlying GI malignancy. CONCLUSIONS: Three simple and objective clinical parameters can be combined to provide a clinically useful cancer risk stratification model for subjects with IDA. This may assist with patient counselling and the prioritisation of investigational resources.

Perineal Assessment and Repair Longitudinal Study (PEARLS): a matched-pair cluster randomized trial.

BACKGROUND: Perineal trauma during childbirth affects millions of women worldwide every year. The aim of the Perineal Assessment and Repair Longitudinal Study (PEARLS) was to improve maternal clinical outcomes following childbirth through an enhanced cascaded multiprofessional training program to support implementation of evidence-based perineal management. METHODS: This was a pragmatic matched-pair cluster randomized controlled trial (RCT) that enrolled women (n = 3681) sustaining a second-degree perineal tear in one of 22 UK maternity units (clusters), organized in 11 matched pairs. Units in each matched pair were randomized to receive the training intervention either early (group A) or late (group B). Outcomes within each cluster were assessed prior to any training intervention (phase 1), and then after the training intervention was given to group A (phase 2) and group B (phase 3). Focusing on phase 2, the primary outcome was the percentage of women who had pain on sitting or walking at 10 to 12 days post-natal. Secondary outcomes included use of pain relief at 10 to 12 days post-natal, need for suture removal, uptake and duration of exclusive breastfeeding, and perineal wound infection. Practice-based measures included implementation of evidence into practice to promote effective clinical management of perineal trauma. Cluster-level paired t-tests were used to compare groups A and B. RESULTS: There was no significant difference between the clusters in phase 2 of the study in the average percentage of women reporting perineal pain on sitting and walking at 10 to 12 days (mean difference 0.7%; 95% CI -10.1% to 11.4%; P = 0.89). The intervention significantly improved overall use of evidence-based practice in the clinical management of perineal trauma. Following the training intervention, group A clusters had a significant reduction in mean percentages of women reporting perineal wound infections and of women needing sutures removed. CONCLUSION: PEARLS is the first RCT to assess the effects of a 'training package on implementation of evidence-based perineal trauma management. The intervention did not significantly improve the primary outcome but did significantly improve evidence-based practice and some of the relevant secondary clinical outcomes for women. TRIAL REGISTRATIONS: ISRCTN28960026 NIHR UKCRN portfolio no: 4785.

A pragmatic parallel arm multi-centre randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based fatigue management programme (FACETS) for people with multiple sclerosis.

BACKGROUND: Fatigue is a common and troubling symptom for people with multiple sclerosis (MS). AIM: To evaluate the effectiveness and cost-effectiveness of a six-session group-based programme for managing MS-fatigue (Fatigue: Applying Cognitive behavioural and Energy effectiveness Techniques to lifeStyle (FACETS)). METHODS: Three-centre parallel arm randomised controlled trial with economic evaluation. Patients with MS and significant fatigue were randomised to FACETS plus current local practice (FACETS) or current local practice alone (CLP), using concealed computer-generated randomisation. Participant blinding was not possible. Primary outcomes were fatigue severity (Fatigue Assessment Instrument), self-efficacy (Multiple Sclerosis-Fatigue Self-Efficacy) and disease-specific quality of life (Multiple Sclerosis Impact Scale (MSIS-29)) at 1 and 4 months postintervention (follow-up 1 and 2). Quality adjusted life years (QALYs) were calculated (EuroQoL 5-Dimensions questionnaire and the Short-form 6-Dimensions questionnaire). RESULTS: Between May 2008 and November 2009, 164 patients were randomised; primary outcome data were available for 146 (89%). Statistically significant differences favour the intervention group on fatigue self-efficacy at follow-up 1 (mean difference (MD) 9, 95% CI (4 to 14), standardised effect size (SES) 0.54, p=0.001) and follow-up 2 (MD 6, 95% CI (0 to 12), SES 0.36, p=0.05) and fatigue severity at follow-up 2 (MD -0.36, 95% CI (-0.63 to -0.08), SES -0.35, p=0.01) but no differences for MSIS-29 or QALYs. No adverse events reported. Estimated cost per person for FACETS is £453; findings suggest an incremental cost-effectiveness ratio of £2157 per additional person with a clinically significant improvement in fatigue. CONCLUSIONS: FACETS is effective in reducing fatigue severity and increasing fatigue self-efficacy. However, it is difficult to assess the additional cost in terms of cost-effectiveness (ie, cost per QALY) as improvements in fatigue are not reflected in the QALY outcomes, with no significant differences between FACETS and CLP. The strengths of this trial are its pragmatic nature and high external validity. TRIAL REGISTRATION: Current Controlled Trials ISRCTN76517470.

The Person-Centered Dermatology Self-Care Index: a tool to measure education and support needs of patients with long-term skin conditions.

OBJECTIVE: To validate the Person-Centered Dermatology Self-Care Index (PeDeSI) as a tool for clinical assessment and for potential use in research evaluation. DESIGN: To date, no validated assessment measures exist to identify the education and support needs of patients living with long-term dermatological conditions and to enable them to self-manage as effectively as possible. The PeDeSI assessment tool was developed to meet this need using the self-efficacy construct and a model of concordance within prescribing practice. In total, 200 copies of the PeDeSI were distributed for validation, and 145 (72.5%) were returned completed. Data were analyzed using statistical software. Frequency distributions of all items were examined, and internal consistency was summarized using Cronbach α. Exploratory factor analysis was used to disclose any underlying structure among the data items. SETTING Three specialist dermatology centers in acute care hospitals. PARTICIPANTS: Dermatology specialist nurses treating patients with chronic dermatoses. INTERVENTION: A PeDeSI was completed with each patient during his or her usual outpatient consultation. MAIN OUTCOME MEASURE: Cronbach α. RESULTS: Cronbach α was 0.90, indicating good internal consistency. Eliminating individual items in turn made little difference in Cronbach α (range, 0.89-0.90). Item total correlations ranged from 0.44 to 0.76 (median, 0.68). Exploratory factor analysis extracted just one factor (eigenvalue, 5.37), with no other factors having eigenvalues exceeding 1.00. Factor loadings on individual items ranged from 0.47 to 0.80. CONCLUSION The PeDeSI is a valid, reliable, and clinically practical tool to systematically assess the education and support needs of patients with long-term dermatological conditions and to promote treatment concordance.