The Functional Assessment of Chronic Illness Therapy (FACIT) Measurement System is a collection of health-related quality of life (HRQOL) questionnaires targeted to the management of chronic illness. ...The measurement system, under development since 1987, began with the creation of a generic CORE questionnaire called the Functional Assessment of Cancer Therapy-General (FACT-G). The FACT-G (now in Version 4) is a 27-item compilation of general questions divided into four primary QOL domains: Physical Well-Being, Social/Family Well-Being, Emotional Well-Being, and Functional Well-Being. It is appropriate for use with patients with any form of cancer, and extensions of it have been used and validated in other chronic illness condition (e.g., HIV/AIDS; multiple sclerosis; Parkinson's disease; rheumatoid arthritis), and in the general population. The FACIT Measurement System now includes over 400 questions, some of which have been translated into more than 45 languages. Assessment of any one patient is tailored so that the most-relevant questions are asked and administration time for any one assessment is usually less than 15 minutes. This is accomplished both by the use of specific subscales for relevant domains of HRQOL, or computerized adaptive testing (CAT) of selected symptoms and functional areas. FACIT questionnaires can be administered by self-report (paper or computer) or interview (face-to-face or telephone). Available scoring, normative data and information on meaningful change now allow one to interpret results in the context of a growing literature base.
Abstract
Study Objectives
To determine whether sleep at baseline (before therapy) predicted improvements in language following either language therapy alone or coupled with transcranial direct ...current stimulation (tDCS) in individuals with primary progressive aphasia (PPA).
Methods
Twenty-three participants with PPA (mean age 68.13 ± 6.21) received written naming/spelling therapy coupled with either anodal tDCS over the left inferior frontal gyrus (IFG) or sham condition in a crossover, sham-controlled, double-blind design (ClinicalTrials.gov identifier: NCT02606422). The outcome measure was percent of letters spelled correctly for trained and untrained words retrieved in a naming/spelling task. Given its particular importance as a sleep parameter in older adults, we calculated sleep efficiency (total sleep time/time in bed x100) based on subjective responses on the Pittsburgh Sleep Quality Index (PSQI). We grouped individuals based on a median split: high versus low sleep efficiency.
Results
Participants with high sleep efficiency benefited more from written naming/spelling therapy than participants with low sleep efficiency in learning therapy materials (trained words). There was no effect of sleep efficiency in generalization of therapy materials to untrained words. Among participants with high sleep efficiency, those who received tDCS benefitted more from therapy than those who received sham condition. There was no additional benefit from tDCS in participants with low sleep efficiency.
Conclusion
Sleep efficiency modified the effects of language therapy and tDCS on language in participants with PPA. These results suggest sleep is a determinant of neuromodulation effects.
Clinical Trial: tDCS Intervention in Primary Progressive Aphasia https://clinicaltrials.gov/ct2/show/NCT02606422
•tDCS over the left IFG improves written naming/spelling more than sham in PPA.•Left AG and left PCC volumes are associated with tDCS effects for trained words.•Left MFG, left SMG, and right PCC ...volumes predict tDCS effect in untrained words.•Lexical/semantic processing in trained items is associated with left AG.•Rule-based generalization in untrained items is associated with left MFG and SMG.
The current study aims to determine the brain areas critical for response to anodal transcranial direct current stimulation (tDCS) in PPA. Anodal tDCS and sham were administered over the left inferior frontal gyrus (IFG), combined with written naming/spelling therapy. Thirty people with PPA were included in this study, and assessed immediately, 2 weeks, and 2 months post-therapy. We identified anatomical areas whose volumes significantly predicted the additional tDCS effects. For trained words, the volumes of the left Angular Gyrus and left Posterior Cingulate Cortex predicted the additional tDCS gain. For untrained words, the volumes of the left Middle Frontal Gyrus, left Supramarginal Gyrus, and right Posterior Cingulate Cortex predicted the additional tDCS gain. These findings show that areas involved in language, attention and working memory contribute to the maintenance and generalization of stimulation effects. The findings highlight that tDCS possibly affects areas anatomically or functionally connected to stimulation targets.
Transcranial direct current stimulation (tDCS), a non-invasive neuromodulation technique, is an effective adjunct to naming treatments in post-stroke aphasia and primary progressive aphasia (PPA). ...Enhanced performance in oral and written naming and spelling of nouns with tDCS has been quantified in detail, but it is not known whether it is effective for verb treatment in PPA. We addressed the question of whether performance in naming and spelling of verbs can be augmented with anodal tDCS over the left inferior frontal gyrus (IFG). We compared tDCS coupled with oral and written verb naming/spelling treatment with oral and written verb naming/spelling treatment alone. In a double-blind, sham-controlled, crossover design, 11 participants with logopenic or non-fluent variant PPA received approximately 15 consecutive sessions of anodal tDCS and sham over the left IFG coupled with oral and written verb-naming + spelling treatment. Written verb-naming performance improved significantly more for trained verbs in the tDCS than the sham condition. Importantly, tDCS effects generalized to untrained items for written verb naming and were significant even at 2 months post-treatment. We conclude that tDCS over the left IFG can improve written verb naming and spelling in PPA.
Transcranial direct current stimulation (tDCS) is an innovative technique recently shown to improve language outcomes even in neurodegenerative conditions such as primary progressive aphasia (PPA), ...but the underlying brain mechanisms are not known. The present study tested whether the additional language gains with repetitive tDCS (over sham) in PPA are caused by changes in functional connectivity between the stimulated area (the left inferior frontal gyrus (IFG)) and the rest of the language network.
We scanned 24 PPA participants (11 female) before and after language intervention (written naming/spelling) with a resting-state fMRI sequence and compared changes before and after three weeks of tDCS or sham coupled with language therapy. We correlated changes in the language network as well as in the default mode network (DMN) with language therapy outcome measures (letter accuracy in written naming).
Significant tDCS effects in functional connectivity were observed between the stimulated area and other language network areas and between the language network and the DMN. TDCS over the left IFG lowered the connectivity between the above pairs. Changes in functional connectivity correlated with improvement in language scores (letter accuracy as a proxy for written naming) evaluated before and after therapy.
These results suggest that one mechanism for anodal tDCS over the left IFG in PPA is a decrease in functional connectivity (compared to sham) between the stimulated site and other posterior areas of the language network. These results are in line with similar decreases in connectivity observed after tDCS over the left IFG in aging and other neurodegenerative conditions.
•A brain mechanism for tDCS over the left IFG in PPA is proposed.•Functional connectivity changes only between the stimulated and temporal areas.•Changes in functional connectivity correlate with language therapy outcomes.•This is the first study providing evidence for tDCS mechanisms in PPA.
Transcranial direct current stimulation (tDCS) over the left inferior frontal gyrus (IFG) was found to improve oral and written naming in post-stroke and primary progressive aphasia (PPA), speech ...fluency in stuttering, a developmental speech-motor disorder, and apraxia of speech (AOS) symptoms in post-stroke aphasia. This paper addressed the question of whether tDCS over the left IFG coupled with speech therapy may improve sound duration in patients with apraxia of speech (AOS) symptoms in non-fluent PPA (nfvPPA/AOS) more than sham. Eight patients with non-fluent PPA/AOS received either active or sham tDCS, along with speech therapy for 15 sessions. Speech therapy involved repeating words of increasing syllable-length. Evaluations took place before, immediately after, and two months post-intervention. Words were segmented into vowels and consonants and the duration of each vowel and consonant was measured. Segmental duration was significantly shorter after tDCS compared to sham and tDCS gains generalized to untrained words. The effects of tDCS sustained over two months post-treatment in trained and untrained sounds. Taken together, these results demonstrate that tDCS over the left IFG may facilitate speech production by reducing segmental duration. The results provide preliminary evidence that tDCS may maximize efficacy of speech therapy in patients with nfvPPA/AOS.
IntroductionCancer symptom monitoring and management interventions can address concerns that may otherwise go undertreated. However, such programmes and their evaluations remain largely limited to ...trials versus healthcare systemwide applications. We previously developed and piloted an electronic patient-reported symptom and need assessment (‘cPRO’ for cancer patient-reported outcomes) within the electronic health record (EHR). This study will expand cPRO implementation to medical oncology clinics across a large healthcare system. We will conduct a formal evaluation via a stepped wedge trial with a type 2 hybrid effectiveness-implementation design.Methods and analysisAim 1 comprises a mixed method evaluation of cPRO implementation. Adult outpatients will complete cPRO assessments (pain, fatigue, physical function, depression, anxiety and supportive care needs) before medical oncology visits. Results are available in the EHR; severe symptoms and endorsed needs trigger clinician notifications. We will track implementation strategies using the Longitudinal Implementation Strategy Tracking System. Aim 2 will evaluate cPRO’s impact on patient and system outcomes over 12 months via (a) a quality improvement study (n=4000 cases) and (b) a human subjects substudy (n=1000 patients). Aim 2a will evaluate EHR-documented healthcare usage and patient satisfaction. In aim 2b, participating patients will complete patient-reported healthcare utilisation and quality, symptoms and health-related quality of life measures at baseline, 6 and 12 months. We will analyse data using generalised linear mixed models and estimate individual trajectories of patient-reported symptom scores at baseline, 6 and 12 months. Using growth mixture modelling, we will characterise the overall trajectories of each symptom. Aim 3 will identify cPRO implementation facilitators and barriers via mixed methods research gathering feedback from stakeholders. Patients (n=50) will participate in focus groups or interviews. Clinicians and administrators (n=40) will complete surveys to evaluate implementation. We will graphically depict longitudinal implementation survey results and code qualitative data using directed content analysis.Ethics and disseminationThis study was approved by the Northwestern University Institutional Review Board (STU00207807). Findings will be disseminated via local and conference presentations and peer-reviewed journals.Trial registration numberNCT04014751; ClinicalTrials.gov.
Transcranial direct current stimulation (tDCS) has been recently shown to improve language outcomes in primary progressive aphasia (PPA) but most studies are small and the influence of PPA variant is ...unknown.
Thirty-six patients with PPA participated in a randomized, sham-controlled, double-blind, within-subject crossover design for 15 daily sessions of stimulation coupled with written naming/spelling therapy. Outcome measures were letter accuracy of treated and untreated words immediately after and at 2 weeks and 2 months posttreatment.
tDCS treatment was more effective than sham: gains for treated words were maintained 2 months posttreatment; gains from tDCS also generalized to untreated words and were sustained 2 months posttreatment. Different effects were obtained for each PPA variant, with no tDCS advantage for semantic variant PPA.
The study supports using tDCS as an adjunct to written language interventions in individuals with logopenic or nonfluent/agrammatic PPA seeking compensatory treatments in clinical settings.
•Anodal tDCS over the left IFG enhances effects of written naming therapy in PPA.•tDCS helps written naming benefits generalize in logopenic and nonfluent PPA.•No generalization occurs for semantic variant PPA with left IFG tDCS.•Behavioral gains sustain for 2 months after tDCS but rescind after sham.•tDCS is a potentially useful adjunct to language therapy in PPA.
Background
The NFLymSI-18 is a patient-reported outcome measure comprised of the highest priority symptoms, emotional concerns, treatment side effects, and other concerns identified by lymphoma ...patients and oncologists. This study assessed the content validity of the NFLymSI-18 for patients with indolent B-cell non-Hodgkin’s lymphoma (iNHL), with a focus on the Disease-Related Symptoms Physical (DRS-P) subscale.
Methods
Patients with a confirmed iNHL diagnosis who had received one or more lines of treatment were recruited during clinic visits. Patients described their symptoms, treatment side effects, and emotional concerns related to iNHL in a semi-structured interview. Qualitative data were analyzed using NVivo10.
Results
Data saturation was obtained by the 18th interview. Most participants (67%) had follicular lymphoma. 28% of participants had marginal zone lymphoma, and one participant had lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia. Mean age of the 18 participants was 67 years. 56% of the sample was male. Most participants (67%) had a college or advanced degree. When asked to describe their iNHL symptoms, patients most often discussed swelling (
n
= 14), fatigue (
n
= 11), and pain (
n
= 8). The following symptoms were mentioned by three patients each: anxiety, appetite loss, rash, sleep disruption, trouble breathing, and malaise. Mapping of NFLymSI-18 content to these concerns showed the instrument includes all those most frequently mentioned symptoms.
Conclusions
This study supports the content validity of the NFLymSI-18, including its DRS-P Subscale, for patients with iNHL. The instrument shows strong validity for the most referenced symptoms of swelling, fatigue, and pain. The diversity of additional symptoms reported by patients is consistent with the heterogeneous symptomology of iNHL.
Longitudinal tracking of implementation strategies is critical in accurately reporting when and why they are used, for promoting rigor and reproducibility in implementation research, and could ...facilitate generalizable knowledge if similar methods are used across research projects. This article focuses on tracking dynamic changes in the use of implementation strategies over time within a hybrid type 2 effectiveness-implementation trial of an evidence-based electronic patient-reported oncology symptom assessment for cancer patient-reported outcomes in a single large healthcare system.
The Longitudinal Implementation Strategies Tracking System (LISTS), a timeline follow-back procedure for documenting strategy use and modifications, was applied to the multiyear study. The research team used observation, study records, and reports from implementers to complete LISTS in an electronic data entry system. Types of modifications and reasons were categorized. Determinants associated with each strategy were collected as a justification for strategy use and a potential explanation for strategy modifications.
Thirty-four discrete implementation strategies were used and at least one strategy was used from each of the nine strategy categories from the Expert Recommendations for Implementing Change (ERIC) taxonomy. Most of the strategies were introduced, used, and continued or discontinued according to a prospective implementation plan. Relatedly, a small number of strategies were introduced, the majority unplanned, because of the changing healthcare landscape, or to address an emergent barrier. Despite changing implementation context, there were relatively few modifications to the way strategies were enacted, such as a change in the actor, action, or dose. Few differences were noted between the trial's three regional units under investigation.
This study occurred within the ambulatory oncology clinics of a large, academic medical center and was supported by the Quality team of the health system to ensure greater uptake, uniformity, and implementation within established practice change processes. The centralized nature of the implementation likely contributed to the relatively low proportion of modified strategies and the high degree of uniformity across regions. These results demonstrate the potential of LISTS in gathering the level of data needed to understand the impact of the many implementation strategies used to support adoption and delivery of a multilevel innovation.
https://clinicaltrials.gov/ct2/show/NCT04014751, identifier: NCT04014751.
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