Single Outcome Measure Research Articles

Reporting of Positive Results in Randomized Controlled Trials of Mindfulness-Based Mental Health Interventions.

BackgroundA large proportion of mindfulness-based therapy trials report statistically significant results, even in the context of very low statistical power. The objective of the present study was to characterize the reporting of “positive” results in randomized controlled trials of mindfulness-based therapy. We also assessed mindfulness-based therapy trial registrations for indications of possible reporting bias and reviewed recent systematic reviews and meta-analyses to determine whether reporting biases were identified.MethodsCINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS databases were searched for randomized controlled trials of mindfulness-based therapy. The number of positive trials was described and compared to the number that might be expected if mindfulness-based therapy were similarly effective compared to individual therapy for depression. Trial registries were searched for mindfulness-based therapy registrations. CINAHL, Cochrane CENTRAL, EMBASE, ISI, MEDLINE, PsycInfo, and SCOPUS were also searched for mindfulness-based therapy systematic reviews and meta-analyses.Results108 (87%) of 124 published trials reported ≥1 positive outcome in the abstract, and 109 (88%) concluded that mindfulness-based therapy was effective, 1.6 times greater than the expected number of positive trials based on effect size d = 0.55 (expected number positive trials = 65.7). Of 21 trial registrations, 13 (62%) remained unpublished 30 months post-trial completion. No trial registrations adequately specified a single primary outcome measure with time of assessment. None of 36 systematic reviews and meta-analyses concluded that effect estimates were overestimated due to reporting biases.ConclusionsThe proportion of mindfulness-based therapy trials with statistically significant results may overstate what would occur in practice.

Cost-effectiveness of a Community-based Rehabilitation Programme in Nepal

Purpose: This study aimed to estimate the cost-effectiveness of a community-based rehabilitation (CBR) programme known as Inspire2Care (I2C), implemented in Nepal by Karuna Foundation Nepal. In the absence of any gold standard methodology to measure cost-effectiveness, the authors developed a new methodology to estimate the programme’s achievements and cost-effectiveness. Methods: Financial records were reviewed to determine total expenditure during the period August 2011 - December 2013. Programme records which documented the physical, mental and social status of children and adults with a disability qualitatively before, during and after the intervention were used to determine a starting disability weight and improvement score, which was then converted into a change in disability weight. The disability weight and expected remaining lifespan of each person were used to estimate disability-adjusted life years (DALYs) averted by the intervention. The cost per DALYaverted was estimated by dividing the total programme expenditure by the sum of DALYs averted over that same period. Results : I2C cost 204,823 Euros to implement over the period August 2011 - December 2013. In total, an estimated 1,065 DALYs were averted from the treatment and rehabilitation components. The cost per DALY averted was 192.34 Euros. Conclusions and Implications: The methodology devised for the study was able to successfully estimate the cost-effectiveness of the I2C programme. Using WHO benchmarks, this programme can be considered highly cost-effective. Other organisations can assess the cost-effectiveness of their programmes by using the assessment improvement score and subsequent conversion to DALYs averted. However, while mental, physical and social gains have been captured, other benefits from I2C cannot be captured in the cost per DALY averted statistic. Further research is needed to develop methods for incorporating these harder-to-measure gains in cost-effectiveness studies with a single outcome measure like the DALY.

Outcome measures in older persons with acquired joint contractures: a systematic review and content analysis using the ICF (International Classification of Functioning, Disability and Health) as a reference.

BackgroundJoint contractures are a common health problem in older persons with significant impact on activities of daily living. We aimed to retrieve outcome measures applied in studies on older persons with joint contractures and to identify and categorise the concepts contained in these outcome measures using the ICF (International Classification of Functioning, Disability and Health) as a reference.MethodsElectronic searches of Medline, EMBASE, CINAHL, Pedro and the Cochrane Library were conducted (1/2002-8/2012). We included studies in the geriatric rehabilitation and nursing home settings with participants aged ≥ 65 years and with acquired joint contractures. Two independent reviewers extracted the outcome measures and transferred them to concepts using predefined conceptual frameworks. Concepts were subsequently linked to the ICF categories.ResultsFrom the 1057 abstracts retrieved, 60 studies met the inclusion criteria. We identified 52 single outcome measures and 24 standardised assessment instruments. A total of 1353 concepts were revealed from the outcome measures; 96.2 % could be linked to 50 ICF categories in the 2nd level; 3.8 % were not categorised. Fourteen of the 50 categories (28 %) belonged to the component Body Functions, 4 (8 %) to the component Body Structures, 26 (52 %) to the component Activities and Participation, and 6 (12 %) to the component Environmental Factors.ConclusionsThe ICF is a valuable reference for identifying and quantifying the concepts of outcome measures on joint contractures in older people. The revealed ICF categories remain to be validated in populations with joint contractures in terms of clinical relevance and personal impact.Electronic supplementary materialThe online version of this article (doi:10.1186/s12877-016-0213-6) contains supplementary material, which is available to authorized users.

Non-invasive Assessment and Symptomatic Improvement of the Obstructed Nose (NASION): a physiology-based patient-centred approach to treatment selection and outcomes assessment in nasal obstruction.

To evaluate the impact of selecting treatment for nasal obstruction on the basis of a structured physiology-based assessment protocol on patient outcomes. Prospective longitudinal study. District general hospital. A population of 71 patients with a mean age of 33 years, containing 36 males, presented with nasal obstruction for consideration of nasal surgery. All patients underwent a structured clinical assessment, skin prick allergy testing and oral-nasal flow-volume loop examination. Fifty-one patients completed the follow-up, and mean follow-up was 11 months. NOSE, SNOT-22 and NASION scales. Of the 51 patients who completed follow-up, six had conservative treatment, 28 had septal/turbinate surgery, and 17 underwent nasal valve surgery. Mean NOSE score fell from 68 ± 18 to 39 ± 31 following the treatment. Mean SNOT-22 score fell from 47 ± 20 to 29 ± 26 following the treatment. The difference between pre-treatment and post-treatment NOSE and SNOT-22 scores were statistically significant. Success rate of septal/turbinate surgery in patients without nasal allergy was 88%, and this fell to 42% in patients undergoing septal/turbinate surgery who also had nasal allergy. Presence of nasal allergy was the only independent predictor of treatment failure. Patients with nasal valve surgery reported significantly greater symptomatic improvement following surgery. The newly formed NASION scale demonstrated internal consistency with a Cronbach α of 0.9 and excellent change-responsiveness and convergent validity with correlation coefficients of 0.64 and 0.77 against treatment-related changes in SNOT-22 and NOSE scales, respectively. Successful surgical outcomes can be achieved with the use of a structured history, clinical evaluation and physiological testing. Flow-volume loops can help elucidate the cause of nasal obstruction. The newly formed NASION scale is a validated retrospective single time-point patient outcome measure.

Relation between Multiple Markers of Work-Related Fatigue.

BackgroundWork-related fatigue has a strong impact on performance and safety but so far, no agreed upon method exists to detect and quantify it. It has been suggested that work-related fatigue cannot be quantified with just one test alone, possibly because fatigue is not a uniform construct. The purpose of this study is therefore to measure work-related fatigue with multiple tests and then to determine the underlying factorial structure.MethodsTwenty-eight employees (mean: 36.11; standard deviation 13.17) participated in five common fatigue tests, namely, posturography, heart rate variability, distributed attention, simple reaction time, and subjective fatigue before and after work. To evaluate changes from morning to afternoon, t tests were conducted. For further data analysis, the differences between afternoon and morning scores for each outcome measure and participant (Δ scores) were submitted to factor analysis with varimax rotation and each factor with the highest-loading outcome measure was selected. The Δ scores from tests with single and multiple outcome measures were submitted for a further factor analysis with varimax rotation.ResultsThe statistical analysis of the multiple tests determine a factorial structure with three factors: The first factor is best represented by center of pressure (COP) path length, COP confidence area, and simple reaction time. The second factor is associated with root mean square of successive difference and useful field of view (UFOV). The third factor is represented by the single Δ score of subjective fatigue.ConclusionWork-related fatigue is a multidimensional phenomenon that should be assessed by multiple tests. Based on data structure and practicability, we recommend carrying out further studies to assess work-related fatigue with manual reaction time and UFOV Subtest 2.

Accuracy of the Adverse Outcome Index: An Obstetrical Quality Measure

In obstetrics, a nationally accepted set of quality indicators for patient safety was not available in the United States until the development of a set of 10 adverse outcome measures-the Adverse Outcome Index (AOI). The National Perinatal Information Center (NPIC) developed hospital discharge data-based algorithms combined with a small set of supplemental patient data for calculation of the AOI. A study was conducted to determine the specificity, sensitivity, positive predictive value (PPV), and negative predictive value (NPV) of the AOI by using the National Perinatal Information Center (NPIC) algorithm. A retrospective chart review of 4,252 obstetrical and neonatal charts from 2003 through 2007 was performed. NPIC definitions were compared with the "gold standard"-chart review. A total of 229 deliveries among the 4,000 randomly selected charts had at least one adverse outcome, reflecting an AOI of 5.7%. For detection of the 10 adverse outcomes within the AOI, the overall sensitivity of the AOI was 81.7%, specificity was 98.2%, PPV was 86.3%, and NPV was 97.4%. The Kappa value for agreement between the coded charts and the chart review was 0.82 (standard deviation=0.01, 95% confidence interval [CI]=0.80-0.85), which is considered very good. The AOI is highly reliant on accurate coding and provider documentation and requires validation with manual chart review. Concurrent chart review improves the accuracy of the AOI. Caution is advised when using the AOI as an exclusive measure of assessing obstetric quality because it may be heavily influenced by a single outcome measure; perineal laceration rates represented twice the frequency of all other outcomes combined. The AOI should be modified to better measure preventable adverse events and include a means of accounting for preexisting conditions.

Perspectives from health, social care and policy stakeholders on the value of a single self-report outcome measure across long-term conditions: a qualitative study

ObjectivesTo explore the views of a range of stakeholders regarding whether patient-reported outcome measures (PROMs) can be developed to measure key attributes of long-term conditions (LTCs) care in England, and...

A 12 month randomised comparative efficacy trial into the treatment of calcaneal apophysitis

Method This is the world’s largest randomised comparative efficacy trial with one, two, six and 12-month follow-up. Children with clinically diagnosed calcaneal apophysitis (n = 124) were recruited. There were two treatment factors within the study. Factor 1 was two different types of in-shoe orthoses: a heel raise or prefabricated orthoses. Treatment factor 2 was footwear replacement. The alternate condition in this factor was no footwear replacement. These interventions were also representative for different hypothesized causative mechanism of calcaneal apophysitis. The primary outcome was pain/disability measured using the Oxford ankle foot questionnaire. The secondary outcomes were pain measured using the Faces pain scale and ankle range of motion measured using the weightbearing lunge test. At the six-month and 12 month follow up point the Oxford ankle foot questionnaire was completed as the single outcome measure. The intervention factors were examined over time on the primary and secondary outcome measures using a generalized estimating equation. Results The children within this study experienced pain for a mean 10.87 (0.61) months prior to intervention. There was no main effect of shoe insert (heel raise v’s prefabricated orthoses), or footwear (usual footwear v’s athletic footwear), nor an insert by footwear interaction effect for three of the four domains of the primary outcome measure. There was a difference in the footwear domain between footwear intervention groups (usual footwear vs. athletic footwear) however the direction of this difference was opposite for children (p=0.02, favouring usual footwear) than for their parent (p=0.017, favouring athletic footwear).

Using Transcranial Magnetic Stimulation as a valid tool to evaluate sports concussion. A systematic review with preliminary results.

Event Abstract Back to Event Using Transcranial Magnetic Stimulation as a valid tool to evaluate sports concussion. A systematic review with preliminary results. Brendan P. Major1*, Mark Rogers1* and Alan Pearce1* 1 Deakin University, Australia This systematic review analysed cortical excitability and inhibition, via transcranial magnetic stimulation (TMS), following sports concussion. The following electronic databases were searched between January and March 2014: PsycINFO, MEDLINE Complete, Psycarticles, Pubmed, Sport Discus, Web of Science, Science Direct, and Cochrane Library using the following inclusion criteria; human, peer reviewed articles published between years 1995 to 2014 in English, age range of 18-60 years, sustained a mild to moderate sports concussion, single pulse TMS outcome measures of motor evoked potentials (MEPs) amplitude and latency, cortical silent period (cSP), short-interval intracortical inhibition (SICI) and long-interval intracortical inhibition. Of the 667 search results 17 studies met the inclusion criteria. For short term (<12 days) 3 studies reported immediate increases in MEP threshold, amplitude and latency following concussion or mild traumatic brain injury. In one study, shortening of cSP was reported 10 days post concussion matched with one reporting and immediate increase following injury. These measures were associated with changes in cognitive performance. For long term investigations (>3 years) 3 studies reported MEP and cSP threshold changes, 4 studies reported lengthening in cSP duration, with one study reporting a reduction. Similarly, cognitive changes were associated with alterations in cSP duration. These results demonstrate the validity of TMS as an investigative tool in elucidating the neurophysiological consequences of a sports concussion and can be used alongside standardised cognitive testing batteries. Keywords: Motor Cortex, Transcranial Magnetic Stimulation, concussion, review, motor evoked potential, Silent Period Conference: XII International Conference on Cognitive Neuroscience (ICON-XII), Brisbane, Queensland, Australia, 27 Jul - 31 Jul, 2014. Presentation Type: Poster Topic: Motor Behaviour Citation: Major BP, Rogers M and Pearce A (2015). Using Transcranial Magnetic Stimulation as a valid tool to evaluate sports concussion. A systematic review with preliminary results.. Conference Abstract: XII International Conference on Cognitive Neuroscience (ICON-XII). doi: 10.3389/conf.fnhum.2015.217.00237 Copyright: The abstracts in this collection have not been subject to any Frontiers peer review or checks, and are not endorsed by Frontiers. They are made available through the Frontiers publishing platform as a service to conference organizers and presenters. The copyright in the individual abstracts is owned by the author of each abstract or his/her employer unless otherwise stated. Each abstract, as well as the collection of abstracts, are published under a Creative Commons CC-BY 4.0 (attribution) licence (https://creativecommons.org/licenses/by/4.0/) and may thus be reproduced, translated, adapted and be the subject of derivative works provided the authors and Frontiers are attributed. For Frontiers’ terms and conditions please see https://www.frontiersin.org/legal/terms-and-conditions. Received: 19 Feb 2015; Published Online: 24 Apr 2015. * Correspondence: Dr. Brendan P Major, Deakin University, Melbourne, Australia, Brendan.major@monash.edu Dr. Mark Rogers, Deakin University, Melbourne, Australia, mark.rogers@deakin.edu.au Dr. Alan Pearce, Deakin University, Melbourne, Australia, alan.pearce@latrobe.edu.au Login Required This action requires you to be registered with Frontiers and logged in. To register or login click here. Abstract Info Abstract The Authors in Frontiers Brendan P Major Mark Rogers Alan Pearce Google Brendan P Major Mark Rogers Alan Pearce Google Scholar Brendan P Major Mark Rogers Alan Pearce PubMed Brendan P Major Mark Rogers Alan Pearce Related Article in Frontiers Google Scholar PubMed Abstract Close Back to top Javascript is disabled. Please enable Javascript in your browser settings in order to see all the content on this page.

Oncology Section EDGE Task Force on Prostate Cancer Outcomes: A Systematic Review of Clinical Measures of Strength and Muscular Endurance

Background: Strength deficits are a common morbidity following treatment for prostate cancer. Accurate assessment of strength and muscular endurance following prostate cancer treatments is essential to identify deficits and plan rehabilitation. Purpose: To identify strength and muscular endurance outcome measures that possess strong psychometric properties and are clinically useful for examination of men treated for prostate cancer. Methods: Multiple electronic databases were searched for articles published after 1995. Studies of tools used to assess strength and muscular endurance were included if they reported psychometric properties, were clinically feasible methods, performed on adults, and published in the English language. Each outcome measure was independently reviewed and rated by two reviewers. A single Cancer EDGE Task Force Outcome Measure Rating Form was completed for each category of strength or endurance assessment, and a recommendation was made using the 4-point Cancer EDGE Task Force Rating Scale. Results: Of the original 683 articles found, 30 were included in this review. Hand-grip strength and hand-held dynamometry were rated 3, recommended for clinical use. One repetition maximum was rated 2A, unable to recommend at this time but the measure has been used in research on individuals with prostate cancer. Manual muscle testing was rated 2B, unable to recommend at this time due to lack of psychometric support, and muscular endurance testing was not recommended (1). Conclusions: Utilizing objective dynamometry for hand grip and muscle strength testing provides precise measurement to assess baseline status and monitor change among men treated for prostate cancer.

Oncology Section EDGE Task Force on Breast Cancer Outcomes: A Systematic Review of Outcome Measures for Functional Mobility

Background: Breast cancer treatments in women with breast cancer often result in physical impairments that lead to activity limitations and participation restrictions. These limitations and restrictions manifest in impaired functional mobility skills that may impact survivorship. Thus, evaluation of functional mobility is an important part of survivorship care. Purpose: To identify functional mobility outcome measures that possess strong psychometric properties and are clinically useful for examination of women treated for breast cancer. Methods: Multiple electronic databases were searched for articles published after 1995. Studies were included if they reported psychometric properties, used clinically feasible methods, were performed on adults, and published in the English language. Each outcome measure was independently evaluated and rated by two reviewers. A single Cancer EDGE Task Force Outcome Measure Rating Form was completed for each category of functional mobility, and a recommendation was made using the 4-point Cancer EDGE Task Force Rating Scale. Results: Of the original 819 articles found, 211 were included in this review. A total of 11 measures are recommended for clinical use: the Timed Up and Go; the 2-Minute, 6-Minute, and 12-Minute Walk Tests; 10-Meter Walk; 5 Times Sit to Stand; Short Performance Physical Battery; Physical Battery for Patients with Cancer; Functional Independence Measure (FIM); Assessment of Life Habits; and Activity Measure for Post-acute Care. Conclusions: Many tools are available to assess upper extremity and overall functional mobility skills in women treated for breast cancer. There are currently no tools recommended that assess community participation.

Evaluating recovery following hip fracture: a qualitative interview study of what is important to patients

ObjectiveTo explore what patients consider important when evaluating their recovery from hip fracture and to consider how these priorities could be used in the evaluation of the quality of hip...

Strength, Multijoint Coordination, and Sensorimotor Processing Are Independent Contributors to Overall Balance Ability.

For young adults, balance is essential for participation in physical activities but is often disrupted following lower extremity injury. Clinical outcome measures such as single limb balance (SLB), Y-balance (YBT), and the single limb hop and balance (SLHB) tests are commonly used to quantify balance ability following injury. Given the varying demands across tasks, it is likely that such outcome measures provide useful, although task-specific, information. But the extent to which they are independent and contribute to understanding the multiple contributors to balance is not clear. Therefore, the purpose of this study was to investigate the associations among these measures as they relate to the different contributors to balance. Thirty-seven recreationally active young adults completed measures including Vertical Jump, YBT, SLB, SLHB, and the new Lower Extremity Dexterity test. Principal components analysis revealed that these outcome measures could be thought of as quantifying the strength, multijoint coordination, and sensorimotor processing contributors to balance. Our results challenge the practice of using a single outcome measure to quantify the naturally multidimensional mechanisms for everyday functions such as balance. This multidimensional approach to, and interpretation of, multiple contributors to balance may lead to more effective, specialized training and rehabilitation regimens.

Acute ischemic stroke prognostication, comparison between Glasgow Coma Score, NIHS Scale and Full Outline of UnResponsiveness Score in intensive care unit

BackgroundStroke is the second most common cause of death worldwide and a frequent cause of adult disability in developed countries. No single outcome measure can describe or predict all dimensions of recovery and disability after acute stroke. Several scales have proven reliability and validity in stroke trials. ObjectivesThe aim of the work was to evaluate the FOUR score predictability for outcome of patients with acute ischemic stroke in comparison with the NIHSS and the GCS. Methods127 adult patients with acute ischemic stroke were enrolled. NIHSS, GCS, and FOUR score were collected at 24 and 72h. Patients were prospectively followed up for the following outcomes; In-hospital or 30days mortality and Modified Rankin Scale (mRS) at 3months. The areas under receiver operating characteristic curve (AUC) were compared between the three scores. ResultsTwenty-five (19.7%) patients died, and seventy-two (56.7%) had unfavourable outcome. The NIHSS, the GCS, and the FOUR score were not different in predicting in-hospital mortality (AUC: 0.783, 0.779, 0.796 at 24-h and 0.973, 0.975, 0.977 at 72-h). The NIHSS, the GCS, and the FOUR score done at 24-h were not different in predicting unfavourable outcome (AUC: 0.893, 0.868, and 0.865, respectively). However, the NIHSS done at 72-h showed significantly higher AUC than the GCS score (0.958 versus 0.931, p=0.041), and higher than the Four score (0.958 versus 0.909, p=0.011). ConclusionsThe GCS and the FOUR score are accurate predictors of mortality after acute ischemic stroke, and are equal in prediction to the NIHSS. The NIHSS is more accurate than the GCS and the FOUR score in predicting poor neurologic outcome.

SAT0356 Discriminant Capacity of Clinical Efficacy Measures, Alone or in Combination with NSAID Intake, in Detecting Anti-TNF Treatment Effect in Spondyloarthritis

BackgroundIn placebo (PBO)-controlled trials of anti-TNF therapy in spondyloarthritis (SpA), background NSAIDs are maintained at stable levels to facilitate demonstration of the anti-TNF treatment effect. In daily practice, most patients...

Using the Bayley-III to assess neurodevelopmental delay: which cut-off should be used?

As the latest edition of the Bayley Scales (Bayley-III) produces higher scores than its predecessor (BSID-II), there is uncertainty about how to classify moderate-severe neurodevelopmental delay. We have investigated agreement between classifications of delay made using the BSID-II and Bayley-III. BSID-II Mental Development Index (MDI) and Bayley-III cognitive and language scales were administered in 185 extremely preterm (<27 wk) children. A combined Bayley-III score (CB-III) was computed. Agreement between delay classified using MDI scores <70 and various Bayley-III cut-offs was assessed. Bayley-III cognitive and language scores were close to the normative mean and were higher than BSID-II MDI scores. Nineteen (10.2%) children had MDI <70. Bayley-III scores <70 significantly underestimated the proportion with MDI <70. Bayley-III cognitive and language scores <85 had 99% agreement with MDI <70 and underestimated delay by 1.1%. CB-III scores <80 had 98% agreement and produced the same proportion with delay. Bayley-III cognitive and language scores <85 or CB-III scores <80 provide the best definition of moderate-severe neurodevelopmental delay for equivalence with MDI <70. CB-III scores have the advantage of producing a single continuous outcome measure but require further validation. The relative accuracy of both tests for predicting long-term outcomes requires investigation.

Five-year follow-up study of multi-domain cognitive training for healthy elderly community members.

BackgroundCognitive training, a safe non-pharmacological intervention, may help mitigate cognitive decline and prevent the development of dementia in elderly individuals.ObjectiveEvaluate the long-term effects of cognitive training among healthy elderly community members.MethodsHealthy individuals 70 years of age or older from one urban community in Shanghai were screened and the 151 individuals who met inclusion criteria were assigned either to an intervention group (n=90) or a control group (n=61). The intervention involved twice-weekly training in reasoning, memory, and strategy that continued for 12 weeks (a total of 24 sessions). Participants were assessed at baseline and at 12 weeks, and 5 years after enrollment using the Chinese versions of the Neuropsychological Test Battery for Elderly persons (NTBE), the Stroop Color-Word Test, and a general health questionnaire.ResultsForty-nine (54%) intervention group subjects and 33 (54%) control group subjects completed the 5-year follow-up. There were few differences in the baseline neurocognitive measures of those who did and did not complete the 5-year follow-up, and there were few differences between those who dropped out of the intervention group compared to those who dropped out of the control group. At the 5-year follow-up, individuals in the intervention group performed better than those in the control group on only 5 measures (in the Trails Making A Test and the Cancellation Test 3) of the 61 measures assessed by NTBE and the Stroop tests, but none of these differences met the pre-determined required level of statistical significance (p=0.0008).ConclusionWe do not confirm the results of previous studies that report long-term benefits of brief cognitive training courses for elderly community residents. Our failure to identify differences in cognitive functioning five years after cognitive training is not likely due to differential dropout between the intervention and control groups but may be related to the relatively small sample and the large number of measures being assessed. Future intervention studies for cognitive training in the elderly should be hypothesis driven (i.e., focused on a single outcome measure of interest), use much larger samples, and include regular booster sessions as part of the cognitive training package.

Outcome Measures for Wheelchair and Seating Provision: A Critical Appraisal

Introduction: Every aspect of the wheelchair and seating provision process has an impact on overall outcomes for service users. This critical appraisal sought to identify outcome measures suitable for evaluation of wheelchair and seating provision, considering activity, participation, and impact of the service delivery on quality of life. Method: Outcome measures were identified using databases: Medline, CINHAL, PsychInfo, and Google Scholar. An evaluation was conducted to establish those that were particularly useful and a critical appraisal was completed. Findings: Five outcome measures identified as relevant for critical appraisal included: Wheelchair Outcome Measure; Functioning Every day in a Wheelchair; Goal Attainment Scale; Psychosocial Impact of Assistive Devices Scales; and the Quebec User Evaluation of Satisfaction with Assistive Technology. The strengths and limitations of each were identified. Conclusion: No single outcome measure captures all necessary information; trade-offs are inevitable. When choosing an outcome measure, the specific goals of the service evaluation and the resources available need to be considered within context. Critical appraisal of five outcome measures deemed appropriate for the evaluation highlighted some areas for consideration to inform decision making. A move towards sustainability indicators is suggested to monitor, measure, and respond to the provision processes and outcomes required to meet this primary need.

Methodological shortcomings make conclusion highly sensitive to relevant changes in review protocol

We will deal with the most serious issue first. KadhimSaleh et al. excluded a study from one of our investigating team stating that “We further excluded Chow et al. [3] because it most likely included the same cohort as Chow et al. [4]”. this serious error would not have occurred if the reviewers were diligent in their processes. the published trial reports clearly stated that one cohort was recruited in 1998 and 1999, and the other cohort recruited in 2002–2003. Rather than contacting the trial authors to resolve uncertainty about the cohorts, which is normal practice for systematic reviewers Kadhim-Saleh et al. decided to base their decision on guess work, clearly not stringent reviewing practice. the hopefully unintentional insinuation that Chow and colleagues duplicated a cohort and included these duplicates as if they were separate cohorts in a subsequent meta-analysis published in the Lancet should be retracted. Kadhim-Saleh et al. criticize our previous meta-analysis because “... investigators included trials that used different and more subjective tools for assessing the primary pain outcome measure. p2494”. In fact we included studies that used several well-recognized and validated scales for pain assessment. this included calculating weighted mean difference for continuous data from visual analogues scale (VAS) scores for pain intensity, relative risk for dichotomized data for global improvement, and standardized mean difference to combine different validated scales of disability including the Neck Disability Index, Neck Disability Scale and the Northwick Park Questionnaire. this enabled us to conduct a comprehensive analysis of the available evidence and we believe that our finding that the results were consistent across the different measurement tools strengthened the robustness of our conclusion. Kadhim-Saleh et al. used a single outcome measure at a single time-point as their only outcome measure of success. We are concerned Dear editor,

Outcome measures in multiple sclerosis.

The acquisition of a reliable and valid outcome measure in multiple sclerosis (MS) is one of the holy grails for clinician researchers working in the field. The current standard for measuring MS-related disability is the Expanded Disability Status Scale (EDSS), a nonlinear scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) [1]. Widely incorporated into MS clinical trials, the EDSS has provided a critical framework for quantifying the toll that MS takes on those who suffer from it and has been considered the “gold standard” for measuring MS-related disability. Because the science to do so was not advanced enough at the time the EDSS was initially developed, however, its measurement properties were never properly evaluated at the time of its creation [2]. Practitioners who see patients with MS can attest to limitations in the neurologic examination, which essentially serves as the basis for the EDSS, in capturing the current clinical status of a patient. For example, a patient diagnosed by one of the editors with primary progressive MS who had an initial EDSS score of 2.0 due to foot drop returned a few months later with resolution of the foot drop (EDSS 1.0), which brought into question whether the course was truly progressive. However, the patient reported continued progression in difficulty functioning, noting that the disease had eliminated the capacity to jog, a favorite pastime. Further, when confronted with the puzzling improvement in the neurologic exam, the patient revealed that while at the previous visit, they had arrived at the office exhausted after walking several miles to get there; they had been dropped off in front of the clinical building for the follow-up visit. This story illustrates some of the problems with the use of the EDSS as a solitary outcome measure in MS. First, it brings the reliability of the scale into question. That a person with MS, particularly with a progressive course, could have such marked fluctuations and indeed even improvements in the score makes the interpretation of the scores difficult. While the EDSS has been shown to be a valid measure of physical disability in adults, there are problems with its reliability, capacity to discriminate between patients or groups thereof, and responsiveness [2]. Further, while the patient in this illustrative case reported worsening physical functioning that greatly impacted subjective quality of life at the second visit, the EDSS score was 1.0, indicating minimal disability. By design, the EDSS was not intended to be a comprehensive measure of the total impact MS has on the life of someone with the disease [2]. These limitations have prompted the search for better outcome measures for use by regulatory agencies approving new medications and for clinicians caring for patients with MS [3]. In this special edition of Multiple Sclerosis International, we sought to include papers that focused on outcome measures for MS. The articles herein range in scope from evaluations of the measurement properties of currently employed definitions of “sustained progression” using the EDSS to the development of a new relapse assessment measure and to measuring specific aspects of MS-related problems, including imbalance, walking impairment, and reduced quality of life. Studies of paraclinical outcomes, including optical coherence tomography and diffusion tensor imaging, and their relation to disability are also included. The reader will appreciate that no single outcome measure is likely to fulfill all needs. Clinical measures that most closely capture the patient's current level of performance or functioning are subject to fluctuations and may be temporally or physiologically disconnected from the disease pathology targeted by treatment. Imaging outcomes may capture features that are more proximate to the pathophysiology of MS but may not reflect findings that will become clinically meaningful. The body of work featured here adds to the dialogue that will inform the development and refinement of outcome measures that more fully capture and quantify the patient experience of MS. Robert Bermel Amy Waldman Ellen M. Mowry