Translation of the Preference-Based Amyotrophic Lateral Sclerosis Scale into French.

The objective of this study was to translate the Preference-Based Amyotrophic Lateral Sclerosis Scale to French-Canadian. After the scale underwent forward and back translations, the expert committee examined the translated versions and found minor grammatical errors and suggested idioms to be changed to better represent French-Canadian language. Cognitive debriefing interviews were carried out to assess the pre-final version for clarity, and minor changes were made. Consensus from the expert committee and people with amyotrophic lateral sclerosis on the measure's clarity, word choice, and meaning were achieved, resulting in the final French version of the Preference-Based Amyotrophic Lateral Sclerosis Scale.

Cognitive Interviewing to Develop a New Health-Related Quality of Life Measure for Parkinson's Disease: The Preference-Based Parkinson's Disease Index (PB-PDI).

Preference-based measures (PBM) for health-related quality of life (HRQoL) are essential in assessing the cost-utility of different treatment options. The preference-based Parkinson's disease Index (PB-PDI) is being developed for people with Parkinson's disease (PD). The aim of this study was to refine the PB-PDI through cognitive interviews with people with PD. Cognitive debriefing was conducted to assess patients' interpretation of items, both in English and French. Participants' feedback guided the iterative modification of the PB-PDI and items were accepted for final inclusion if they were endorsed by three consecutive participants. A total of 16 participants provided feedback on the items, refined the response options, and discussed how to clarify questions. They selected a 2-week timeframe for the PB-PDI recall period. At the end of the cognitive interviews, all seven items and their response options were endorsed in both languages. The cognitive interview process allowed us to refine items and ensure that they were clear in terms of instructions and response options from the perspective of people with PD. The next step will be to elicit preference weights to develop a scoring algorithm and assess its measurement properties.

Factors influencing emergency department observation time following anaphylaxis: a systematic review.

OBJECTIVE: Anaphylaxis is a condition that warrants an observation period after symptoms resolution to detect rare but life-threatening delayed complications. There is a need for evidence to identify patients who would benefit from prolonged observation time. The purpose of this review was to identify factors that may influence the need for longer observation in the emergency department. METHODS: PubMed, Embase, EBM Review, and Cochrane Library were searched using controlled vocabulary and keywords to cover all relevant data. Titles, abstract, and full text were reviewed for inclusion and exclusion criteria. Data were extracted from the included articles regarding case definitions, prognosis, treatment and time factors, and recommended observation time. Factors linked to observation time or complications were tabulated and compared between studies. RESULTS: The search retrieved 2443 citations of which 49 were included. Twenty-one were primary studies and were used to identify factors influencing observation time or complications. Biphasic anaphylaxis was the only adverse event that warranted prolonged observation. The five risk factors often associated with biphasic reactions were time to first epinephrine, history of anaphylaxis, symptom severity, number of epinephrine doses, and unknown trigger. Biphasic reactions happened mostly within the first 72 h with most severe reactions occurring earlier than the milder ones. Heterogeneity in the definition of biphasic anaphylaxis made comparisons challenging. CONCLUSIONS: Observation time should be based on the provider's best estimation of the risk of biphasic anaphylaxis, although no single factor can predict their occurrence. The identified factors will allow the development of an early discharge screening tool.

RéSUMé: OBJECTIF: L'anaphylaxie est une condition qui mérite une période d'observation après la disparition des symptômes pour détecter des complications retardées rares, mais potentiellement mortelles. Il est nécessaire de trouver des preuves pour identifier les patients qui bénéficieraient d'une période d'observation prolongée. Le but de cet examen était d'identifier les facteurs qui pourraient influencer la nécessité d'une période d'observation plus longue aux urgences. MéTHODES: PubMed, Embase, EBM Review et Cochrane Library ont été recherchés au moyen d'un vocabulaire contrôlé et des mots-clés pour couvrir toutes les données pertinentes. Les titres, le résumé et le texte intégral ont été examinés pour les critères d'inclusion et d'exclusion. Les données concernant les définitions de cas, le pronostic, le traitement et la durée de traitement, et la période d'observation recommandée ont été extraites des articles inclus. Les facteurs liés à la période d'observation ou aux complications ont été présentés sous forme de tableau et comparés entre les études. RéSULTATS: La recherche a permis de récupérer 2443 citations dont 49 ont été incluses. Vingt et un étaient des études primaires et ont été utilisées pour identifier les facteurs influençant la période d'observation ou les complications. L'anaphylaxie biphasique était le seul événement indésirable qui méritait une observation prolongée. Les cinq facteurs de risque souvent associés aux réactions biphasiques étaient le délai de la première épinéphrine, les antécédents d'anaphylaxie, la gravité des symptômes, le nombre de doses d'épinéphrine et le déclencheur inconnu. Les réactions biphasiques se sont produites principalement dans les 72 premières heures avec les réactions les plus graves se présentant plus tôt que les réactions plus légères. L'hétérogénéité de la définition de l'anaphylaxie biphasique a rendu les comparaisons difficiles. CONCLUSIONS: La période d'observation doit être basée sur la meilleure estimation du risque d'anaphylaxie biphasique fournie par le professionnel de la santé, bien qu'aucun facteur unique ne puisse prédire son apparition. Les facteurs identifiés permettront le développement d'un outil de dépistage pour les sorties précoces de l'hôpital.

Web-Based Self-Management Guide for Kidney Transplant Recipients (The Getting on With Your Life With a Transplanted Kidney Study): Protocol for Development and Preliminary Testing.

BACKGROUND: Although it is well known that compared with dialysis, kidney transplantation improves the quality of life (QoL) of patients with end-stage renal disease, posttransplant recovery of physical health and other aspects of QoL remain well below age- and sex-matched norms. In addition, most transplant recipients are not physically active even years after the transplant and face several barriers to engaging in physical activity (PA). This is of concern as low levels of PA in transplant recipients has been associated with increased risk of mortality and poor graft function. Optimization of QoL needs a team approach involving the patients and the members of the health care team. While members of the health care team are focused on optimizing the biological responses to transplant, patients may have few or no tools at their disposal to engage in behaviors that optimize QoL. To accomplish the need of supporting these patients in the self-management of their condition and to facilitate engagement with PA, new tools tailored to this population are required. OBJECTIVE: The aim of this protocol study is to develop a Web-based, patient-centered self-management intervention to promote a healthy lifestyle, increase daily PA, and improve QoL in kidney transplant recipients. METHODS: We will use the Obesity-Related Behavioral Intervention Trials model for developing behavioral treatments for chronic diseases to guide the proposed project. We will follow a modified version of the iterative 10-step process that was used to develop educational material for people with multiple sclerosis. The development of the intervention will occur in partnership with patients and a multidisciplinary team of clinicians and researchers. A comprehensive needs assessment including data from our pilot study, literature review, and focus groups will be conducted. The focus groups will be conducted with 6 to 10 participants for each type of stakeholders: patients and professional experts to identify areas of concerns of kidney transplant recipients that are appropriate to address through self-management. The areas of concern identified through the assessment needs will be included in the website. RESULTS: This study has received funding from the Kidney Foundation of Canada for 2 years (2018-2020) and was recently granted ethics approval. Investigators have begun conducting the needs assessment described in step 1 of the study. The study is expected to be completed by the end of 2020. CONCLUSIONS: This will be the first comprehensive, evidence- and experience-based self-management program for kidney transplant recipients. Once the intervention is developed, we anticipate improvements in patient experience, shared decision making, daily PA, QoL, and, in future studies, improvements in health outcomes and demonstrations of cost savings in posttransplant care. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/13420.

Where have all the pilot studies gone? A follow-up on 30 years of pilot studies in Clinical Rehabilitation.

INTRODUCTION: Pilot studies are meritorious for determining the feasibility of a definitive clinical trial in terms of conduct and potential for efficacy, but their possible applications for planning a future trial are not always fully realized. The purpose of this review was to estimate the extent to which pilot/feasibility studies: (i) addressed needed objectives; (ii) led to definitive trials; and (iii) whether the subsequent undertaking of a definitive trial was influenced by the strength of the evidence of outcome improvement. METHODS: Trials published in the journal Clinical Rehabilitation, since its inception, were eligible if the word 'pilot' or 'feasibility' was specified somewhere in the article. A total of 191 studies were reviewed, results were summarized descriptively, and between-group effect sizes were computed. RESULTS: The specific purposes of piloting were stated in only 58% ( n = 110) of the studies. The most frequent purpose was to estimate the potential for efficacy (85%), followed by testing the feasibility of the intervention (60%). Only 12% of the studies were followed by a definitive trial; <4% of studies had a main study underway or a published study protocol. There was no relationship between observed effect size and follow-up of pilot studies, although the confidence intervals were very wide owing to small number of trials that followed on. DISCUSSION: Labelling and reporting of pilot studies needs to be improved to be concordant with the recently issued CONSORT guidelines. Feasibility needs to be fully tested and demonstrated prior to committing considerable human and monetary resources.

Path to Illness Intrusiveness: What Symptoms Affect the Life of People Living With Multiple Sclerosis?

OBJECTIVE: To determine the direct and indirect effects of physical, emotional, and cognitive impairments on illness intrusiveness in people with multiple sclerosis (MS). DESIGN: Secondary analysis of a cross-sectional data set collected in 2008 to identify sex differences in people living with MS. SETTING: Three MS clinics. PARTICIPANTS: A random sample (N=189) of women and men diagnosed with MS after 1995 were recruited and evaluated in 2008. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURE: Illness Intrusiveness Rating Scale (updated version using Rasch analysis). RESULTS: Path analysis yielded a model that was significant (nonnormed fit index, .9913; normed fit index, .9846) with adequate fit of the data to the model (goodness of fit index, .9781; χ2=21.41; P=.2084). The model explained 55% of the variance of illness intrusiveness. Only emotional and physical aspects were represented in the model because no cognitive impairment stayed after variable reduction. The model showed the complete mediation effect of fatigue on the physical function variables. CONCLUSIONS: This project brings new evidence toward the conceptualization of illness intrusiveness as a construct allowing future interventions that wish to target illness intrusiveness or disease impact to be designed. It also presented statistical evidence of the importance of treating fatigue not only as a symptom but also as a consequence of other impairments.

Enrolling and keeping participants in multiple sclerosis self-management interventions: a systematic review and meta-analysis.

OBJECTIVES: The objectives were to provide an estimate of expected enrolment and attrition rates based on published studies of existing self-management interventions for people with multiple sclerosis, and to identify contributing factors and impact on outcomes. REVIEW METHODS: A systematic literature search was conducted using Ovid MEDLINE, PsychINFO, EMBASE, AMED, CINAHL, OT Seeker, PubMed, and the Cochrane Database of Systematic Reviews databases. Controlled trials with or without randomization using either a between-group or within-person design were included if they met specified criteria. A random-effect meta-regression analysis was conducted to estimate the overall enrolment and attrition proportions, effect of person- and study-related factors, and impact on outcomes. RESULTS: A total of 48 studies, comprising 4446 persons were identified. The estimated enrolment rate was 50.3% (95% confidence interval (CI): 49.6 to 51.1) and the estimated attrition rates in the intervention and control groups were 16.8% (95% CI: 16.2 to 17.3) and 14.4% (95% CI: 13.8 to 14.9), respectively. The main reported reason for refusing to participate was lack of interest (70.6%), while the reported reasons for dropping out were mainly owing to medical issues (26.1%) and disliking the intervention (17.9%). Trial, programme, and patient-related variables were found to influence the enrolment and/or attrition rates. Studies that had a 10% higher attrition rate had an effect size that was larger by 0.19 (95% CI: 0.17 to 0.24). CONCLUSION: Greater understanding of the factors associated with enrolment and attrition rates would help in planning and developing a more appealing self-management intervention that patients can easily accept and incorporate into their everyday lives.

How have research questions and methods used in clinical trials published in Clinical Rehabilitation changed over the last 30 years?

Research in rehabilitation has grown from a rare phenomenon to a mature science and clinical trials are now common. The purpose of this study is to estimate the extent to which questions posed and methods applied in clinical trials published in Clinical Rehabilitation have evolved over three decades with respect to accepted standards of scientific rigour. Studies were identified by journal, database, and hand searching for the years 1986 to 2016.A total of 390 articles whose titles suggested a clinical trial of an intervention, with or without randomization to form groups, were reviewed. Questions often still focused on methods to be used (57%) rather than what knowledge was to be gained. Less than half (43%) of the studies delineated between primary and secondary outcomes; multiple outcomes were common; and sample sizes were relatively small (mean 83, range 5 to 3312). Blinding of assessors was common (72%); blinding of study subjects was rare (19%). In less than one-third of studies was intention-to-treat analysis done correctly; power was reported in 43%. There is evidence of publication bias as 83% of studies reported either a between-group or a within-group effect. Over time, there was an increase in the use of parameter estimation rather than hypothesis testing and there was evidence that methodological rigour improved.Rehabilitation trialists are answering important questions about their interventions. Outcomes need to be more patient-centred and a measurement framework needs to be explicit. More advanced statistical methods are needed as interventions are complex. Suggestions for moving forward over the next decades are given.

Development of a Bilingual MS-Specific Health Classification System: The Preference-Based Multiple Sclerosis Index.

OBJECTIVE: The global aim of this study was to contribute to the development of the Preference-Based Multiple Sclerosis Index (PBMSI). The specific objective of this foundational work was to qualitatively review the items selected for inclusion in the PBMSI using expert and patient feedback. METHODS: Cognitive interviews were conducted with patients with multiple sclerosis (MS) in English and French. The verbal probing method was used to conduct the interviews. For each PBMSI item, the interviewer probed for specific information on what types of difficulty participants had with the item and the basis for their response for each item. Furthermore, respondents were asked to provide information on the clarity of the item, the meaning of the item, the appropriateness of the response options, and the recall period. All interviews were recorded using a digital voice recorder and were transcribed onto a computer. RESULTS: The mean age of the 22 respondents was 52 years, and 82% were women. Mean time since diagnosis was 12 years, and the highest level of education completed was university or college for 86% of the sample. Modifications were made to each item in terms of recall period, instructions, and phrasing. CONCLUSIONS: Patient and expert feedback allowed us to clarify items, simplify language, and make items more uniform in terms of their instructions and response options. This qualitative review process will increase accuracy of reporting and reduce measurement error for the PBMSI.

Predictors of persistent psychotic symptoms in persons with methamphetamine abuse receiving psychiatric treatment.

The objective of this study was to identify predictors of sustained psychotic symptoms after methamphetamine (MA) abuse during the course of 6 months from patterns of MA and other substance use, depressive symptoms, family history of psychosis, antisocial personality disorder, and trauma history. A total of 295 individuals with MA abuse and psychotic symptoms seeking psychiatric services were assessed at baseline and then monthly on symptoms and substance use for 6 months. Trajectory analyses revealed two trajectories of the individuals with positive symptoms, with one group presenting with persistent psychotic symptoms (30% of the sample). Those with persistent psychosis were significantly older, had more severe psychotic symptoms, misused MA for more years, had more antisocial personality traits, and had more sustained depressive symptoms. The strongest predictors of belonging to the persistent psychosis group, via logistic regressions, were more severe psychotic symptoms, longer use of MA, and sustained depressive symptoms. Our results highlight the important comorbidities, especially regarding depressive symptoms and persistent psychosis, in individuals seeking psychiatric help after MA abuse. This study also highlights the importance of identifying people with persistent psychosis within MA users to facilitate rapid and effective treatment of co-occurring psychotic disorder.

Mindfulness-based therapy: a comprehensive meta-analysis.

BACKGROUND: Mindfulness-based therapy (MBT) has become a popular form of intervention. However, the existing reviews report inconsistent findings. OBJECTIVE: To clarify these inconsistencies in the literature, we conducted a comprehensive effect-size analysis to evaluate the efficacy of MBT. DATA SOURCES: A systematic review of studies published in journals or in dissertations in PubMED or PsycINFO from the first available date until May 10, 2013. REVIEW METHODS: A total of 209 studies (n=12,145) were included. RESULTS: Effect-size estimates suggested that MBT is moderately effective in pre-post comparisons (n=72; Hedge's g=.55), in comparisons with waitlist controls (n=67; Hedge's g=.53), and when compared with other active treatments (n=68; Hedge's g=.33), including other psychological treatments (n=35; Hedge's g=.22). MBT did not differ from traditional CBT or behavioral therapies (n=9; Hedge's g=-.07) or pharmacological treatments (n=3; Hedge's g=.13). CONCLUSION: MBT is an effective treatment for a variety of psychological problems, and is especially effective for reducing anxiety, depression, and stress.