scholarly journals What matters to children with CFS/ME? A conceptual model as the first stage in developing a PROM

2015 ◽  
Vol 100 (12) ◽  
pp. 1141-1147 ◽  
Author(s):  
Roxanne Parslow ◽  
Aarti Patel ◽  
Lucy Beasant ◽  
Kirstie Haywood ◽  
Debbie Johnson ◽  
...  
Keyword(s):  
Focus Group ◽  
Conceptual Model ◽  
Well Being ◽  
Chronic Fatigue ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Fatigue Syndrome ◽  
Patient Reported ◽  
The Impact ◽  
The Relationship

BackgroundPaediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) is relatively common and disabling. Research is hampered because current patient-reported outcome measures (PROMs) do not capture outcomes that are important to children with CFS/ME.AimThe aim of this study was to explore the aspects of life and health outcomes that matter to children with CFS/ME.MethodsTwenty-five children with CFS/ME were interviewed (11 males, 14 females; mean age 12.9 years (SD 2.2), range 8–17). Twelve were trial participants interviewed during the trial and 13 were recruited as part of a follow-up qualitative study. Parents were present in 19 interviews with their children. Three mothers participated in a focus group. All the interviews and the focus group were audio-recorded and transcribed. Data were analysed thematically using techniques of constant comparison. NVivo was used to structure and categorise data in a systematic way.ResultsChildren identified four key themes (health outcome domains): ‘symptoms’ that fluctuated, which caused an unpredictable reduction in both ‘physical activity’ and ‘social participation’ all of which impacted on ‘emotional well-being’. These domains were influenced by both ‘management’ and ‘contextual factors’, which could be positive and negative. The relationship between healthcare and school was considered pivotal.ConclusionsChildren's descriptions helped to inform a conceptual model that is necessary to develop a new paediatric CFS/ME PROM. Doctors need to be aware of how children conceptualise CFS/ME; the relationship between healthcare and school is fundamental to ameliorate the impact of CFS/ME.Trial registration numberISRCTN81456207.

scholarly journals AB0051 THE EFFECTS OF NON-INVASIVE VAGUS NERVE STIMULATION ON IMMUNOLOGICAL RESPONSES AND PATIENT REPORTED OUTCOME MEASURES OF FATIGUE IN PATIENTS WITH CHRONIC FATIGUE SYNDROME, FIBROMYALGIA, AND RHEUMATOID ARTHRITIS

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1057.3-1058
Author(s):  
E. Traianos ◽  
B. Dibnah ◽  
D. Lendrem ◽  
Y. Clark ◽  
V. Macrae ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Daytime Sleepiness ◽  
Vagus Nerve Stimulation ◽  
Chronic Fatigue ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Physical Fatigue ◽  
Fatigue Syndrome ◽  
Tnf Α ◽  
Patient Reported

Background:Fatigue is reported as a common symptom among autoimmune and other chronic diseases such as fibromyalgia (FM), a long-term condition with uncertain pathophysiology. Previous studies from our group suggest that non-invasive vagus nerve stimulation (nVNS) may contribute to the improvement of patient reported outcome measures (PROMs) of fatigue in patients with primary Sjögren’s Syndrome (1).Objectives:This follow-up study uses the gammaCore device (electroCore) to assess the effect of nVNS on PROMs of fatigue and immune responses in chronic fatigue syndrome (CFS), FM and rheumatoid arthritis (RA).Methods:The study included thirteen CFS, fourteen FM and fifteen RA patients who used the gammaCore nVNS device twice daily over a 26-day period. Pre- and post- nVNS bloods were drawn at baseline and final visits. Whole blood samples were stimulated with 2 ng/mL lipopolysaccharide (LPS) and the IL-6 and TNF-α cytokine concentrations were quantified at 24 hours. In addition, the epidermal growth factor (EGF), IFN-γ, IL-6, IP-10, MIP-1α, and TNF-α levels were measured in ‘pre-nVNS’ serum and flow cytometric profiles of whole blood immune cells were analysed. The patient reported outcome measures (PROMs) recorded at each visit were the Visual Analogue Scale (VAS) (0-100 cm) of abnormal fatigue, Hospital Anxiety and Depression (HAD) Scale, Orthostatic Grading Scale, Epworth Sleepiness Scale (daytime sleepiness), and Profile of fatigue (PRO-F) for Physical and Mental fatigue. Paired t-tests were performed to assess for changes in PROMs, cytokine levels, and cell subset distribution and associations of cytokine response with PROMs were investigated by correlation analyses.Results:Eleven CFS, twelve FM and fourteen RA patients completed the study. There was a significant reduction in daytime sleepiness in CFS (p =0.0321) and FM (p =0.0294) patients between the final and baseline visits and a significant reduction in HAD depression (p =0.0413) in FM (Fig.1). Improvement in VAS for abnormal fatigue, HAD-Anxiety, HAD-Depression, PRO-F Physical and Mental fatigue was observed in all three groups over the study period with a reduction in VAS fatigue in 64% of CFS, 67% of FM and 62% of RA patients. There were no significant changes in the immune cell subsets or in cytokine response. Finally, higher baseline pre-nVNS supernatant IL-6 levels were predictive of an improvement in VAS fatigue (p =0.0006), Daytime Sleepiness (p =0.0466) and PRO-F Physical fatigue (p =0.0196) in RA, while higher baseline TNF-α levels were predictive of an improvement in VAS fatigue (p =0.0003), Daytime Sleepiness (p =0.0380), Orthostatic (p =0.0281) and PRO-F Physical fatigue (p =0.0007) in FM.Conclusion:Our findings suggest that nVNS may contribute to the improvement of PROMs of fatigue in CFS, FM and RA. NVNS led to significant reductions in daytime sleepiness in CFS and FM, and depression in FM. Further studies and a larger sample size are needed to investigate the potential effects of nVNS on diseases characterised by persistent fatigue.References:[1]Tarn J, Legg S, Mitchell S, Simon B, Ng WF. The Effects of Noninvasive Vagus Nerve Stimulation on Fatigue and Immune Responses in Patients With Primary Sjögren’s Syndrome. Neuromodulation Technol Neural Interface. 2018;22(5):580–5.Figure 1.VAS for abnormal fatigue and PROMs recorded at baseline and final visits in patients with chronic fatigue syndrome (CFS), fibromyalgia (FM) and rheumatoid arthritis (RA). Boxplots show the median, upper, and lower quartiles for PROMs at visit 1 and visit 3 in each disease group. Paired-t tests revealed a significant reduction in daytime sleepiness in CFS and FM (B), and a significant reduction in HAD depression in FM (E). Improvement trends were observed in VAS for abnormal fatigue, HAD-Anxiety, HAD-Depression, PRO-F Physical fatigue and PRO-F Mental fatigue in all three groups over the 26-day study period.Acknowledgements:This study received infrastructural support from the National Institute of Health Research (NIHR) Newcastle Biomedical Research Centre at Newcastle Hospitals Foundation Trust and Newcastle University.Disclosure of Interests:Emmanuella Traianos: None declared, Bethany Dibnah: None declared, Dennis Lendrem: None declared, Yasmin Clark: None declared, Victoria Macrae: None declared, Victoria Slater: None declared, Karl Wood: None declared, David Storey: None declared, Bruce Simon Shareholder of: Bruce Simon is an employee and shareholder of electroCore., Employee of: electroCore, Inc., Justyna Blake Shareholder of: Justyna Blake is an employee of electroCore, and receives stock ownership., Employee of: electroCore, Inc., Jessica Tarn: None declared, Wan Fai Ng: None declared

A Pilot Study of Olfactory Training in Older Hyposmic Adults

2019 ◽  
Vol 33 (6) ◽  
pp. 650-656 ◽  
Author(s):  
Jensine M. Lamira ◽  
Zachary M. Soler ◽  
Rodney J. Schlosser
Keyword(s):  
Well Being ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Neural Regeneration ◽  
Subjective Well Being ◽  
Olfactory Loss ◽  
Patient Reported ◽  
Baseline Factors ◽  
The Impact ◽  
Olfactory Training

Background Olfactory loss is a common problem that significantly impacts quality of life. Olfactory training (OT) has been used most commonly for viral and traumatic olfactory dysfunction (OD) in younger subjects with hopes of neural regeneration, improved olfactory function, and subjective well-being. The objective of this study was to investigate the impact of a novel form of OT using 12 odors in participants over 45 years of age with objective OD. Methods Twenty-nine participants underwent OT using 12 standardized odor pens for a duration of 6 months. Objective OT of Threshold, Discrimination, and Identification and patient-reported outcomes were assessed at baseline and after 6 months of OT. Results Of the 29 participants who entered the protocol, only 16 subjects completed all 6 months of OT. Significant improvements were seen in overall Threshold Discrimination Identification (TDI; mean 4.40 points, P = .007), Discrimination (mean 1.44 points, P = .019), and Identification (mean 2.02 points, P = .011). Forty-four percent of subjects who completed OT achieved a mean clinically important difference of at least 5.5 points on TDI. Conclusion There was no significant change in patient-reported outcome measures, and no baseline factors were associated with change in olfaction. In this study, OT with 12 odors improves objective olfaction in nearly half of the older adults with OD. Further investigation is necessary to determine the impact of improved olfaction on overall health outcomes.

scholarly journals Practices and pitfalls in medication adherence in hemodialysis settings – a focus-group study of health care professionals

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Trine Mechta Nielsen ◽  
Nina Schjerning ◽  
Gudrun Kaldan ◽  
Mads Hornum ◽  
Bo Feldt-Rasmussen ◽  
...  
Keyword(s):  
Health Care ◽  
Medication Adherence ◽  
Focus Group ◽  
Health Care Professionals ◽  
Patient Adherence ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Focus Group Study ◽  
Patient Reported ◽  
The Impact

Abstract Background Medication nonadherence is common among patients with hemodialysis, leading to poorer patient outcomes. Health care professionals have an important role in assessing risk of nonadherence and intervening to support adherence. The aim of this study was to explore physicians’ and nurses’ current medication adherence practices in hemodialysis settings. Method A generic qualitative design with inductive content analysis and focus group methodology. Focus groups with health care professionals were conducted in four Nephrology Centers, representing three different regions of Denmark. An interview guide was developed in collaboration with 3 patient representatives. Results Six focus group interviews involving a total of forty-two health care professionals were conducted. Five main categories were identified; Laboratory tests are the “gold standard” for assessing adherence, suggesting that abnormal results motivated investigation of adherence, Varying practices for supporting adherence, alluding to the impact of individual clinician priority and preference on choice of adherence interventions, Unclear allocation of roles and responsibility, specifically referring to uncertainty in the delegation of roles between physicians and nurses, Navigating time and resource limitations, intimating the resources needed to support medication adherence and Suggestions for future strategies. Conclusions We suggest implementing systematic use of validated patient-reported outcome measures for assessing adherence and deprescribing tools to support adherence, as these instruments might identify the patients who are in most need of support and promote patient adherence to their prescribed medications. The findings also point to a need for interdisciplinary clarification of roles and responsibilities regarding medication adherence, with the aim of building a strong collaborative partnership between professions.

scholarly journals The utility of patient-reported outcome measures among patients with myalgic encephalomyelitis/chronic fatigue syndrome

2016 ◽  
Vol 26 (4) ◽  
pp. 913-921 ◽  
Author(s):  
Kyle W. Murdock ◽  
Xin Shelley Wang ◽  
Qiuling Shi ◽  
Charles S. Cleeland ◽  
Christopher P. Fagundes ◽  
...  
Keyword(s):  
Chronic Fatigue Syndrome ◽  
Outcome Measures ◽  
Chronic Fatigue ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Myalgic Encephalomyelitis ◽  
Fatigue Syndrome ◽  
Patient Reported

scholarly journals Patients' perceptions and patient-reported outcomes in progressive-fibrosing interstitial lung diseases

2018 ◽  
Vol 27 (150) ◽  
pp. 180075 ◽  
Author(s):  
Jeffrey J. Swigris ◽  
Kevin K. Brown ◽  
Rayid Abdulqawi ◽  
Ketan Buch ◽  
Daniel F. Dilling ◽  
...  
Keyword(s):  
Treatment Options ◽  
Well Being ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Interstitial Lung Diseases ◽  
Therapeutic Interventions ◽  
Patient Reported ◽  
Significant Burden ◽  
And Function ◽  
The Impact

The effects of interstitial lung disease (ILD) create a significant burden on patients, unsettling almost every domain of their lives, disrupting their physical and emotional well-being and impairing their quality of life (QoL). Because many ILDs are incurable, and there are limited reliably-effective, life-prolonging treatment options available, the focus of many therapeutic interventions has been on improving or maintaining how patients with ILD feel and function, and by extension, their QoL. Such patient-centred outcomes are best assessed by patients themselves through tools that capture their perceptions, which inherently incorporate their values and judgements. These patient-reported outcome measures (PROs) can be used to assess an array of constructs affected by a disease or the interventions implemented to treat it. Here, we review the impact of ILD that may present with a progressive-fibrosing phenotype on patients' lives and examine how PROs have been used to measure that impact and the effectiveness of therapeutic interventions.

Optimizing electronic capture of patient-reported outcome measures in oncology clinical trials: lessons learned from a qualitative study

2020 ◽  
Vol 9 (17) ◽  
pp. 1195-1204
Author(s):  
Florence D Mowlem ◽  
Brad Sanderson ◽  
Jill V Platko ◽  
Bill Byrom
Keyword(s):  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Lessons Learned ◽  
Structured Interviews ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Anticancer Treatment ◽  
Fit For Purpose ◽  
The Impact ◽  
Electronic Implementation

Aim: To understand the impact of anticancer treatment on oncology patients’ ability to use electronic solutions for completing patient-reported outcomes (ePRO). Materials & methods: Semi-structured interviews were conducted with seven individuals who had experienced a cancer diagnosis and treatment. Results: Participants reported that the following would impact the ability to interact with an ePRO solution: peripheral neuropathy of the hands (4/7), fatigue and/or concentration and memory issues (6/7), where they are in a treatment cycle (5/7). Approaches to improve usability included: larger, well-spaced buttons to deal with finger numbness, the ability to pause a survey and complete at a later point and presenting the recall period with every question to reduce reliance on memory. Conclusion: Symptoms associated with cancers and anticancer treatments can impact the use of technologies. The recommendations for optimizing the electronic implementation of patient-reported outcome instruments in this population provides the potential to improve data quality in oncology trials and places patient needs at the forefront to ensure ‘fit-for-purpose’ solutions.

scholarly journals Exploratory study into the relationship between the symptoms of chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) and fibromyalgia (FM) using a quasiexperimental design

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e041947
Author(s):  
Pamela G Mckay ◽  
Helen Walker ◽  
Colin R Martin ◽  
Mick Fleming
Keyword(s):  
Quality Of Life ◽  
Chronic Fatigue Syndrome ◽  
Chronic Fatigue ◽  
Myalgic Encephalomyelitis ◽  
Anxiety And Depression ◽  
Symptom Experience ◽  
Fatigue Syndrome ◽  
The Impact ◽  
The Relationship

ObjectiveTo explore the relationship between symptoms of chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME) and fibromyalgia (FM). The hypothesis predicated that there would be no significant differences between the group’s symptom experience.DesignA quasiexperimental design. Structural equation modelling (SEM) and invariance testing.ParticipantsMales (M) and females (F) >16 with a confirmed diagnosis of CFS/ME or FM by a general practitioner or specialist. CFS/ME (n=101, F: n=86, M: n=15, mean (M) age M=45.5 years). FM (n=107, F: n=95, M: n=12, M=47.2 years).Outcome measuresDiagnostic criteria: the American Centers for Disease Control and Prevention (CDC) for CFS/ME and the American College of Rheumatology (ACR) criteria for FM. Additional symptom questionnaires measuring: pain, sleep quality, fatigue, quality of life, anxiety and depression, locus of control and self-esteem.ResultsInvariance was confirmed with the exception of the American CDC Symptom Inventory, Fibromyalgia Impact Questionnaire and Hospital Anxiety and Depression Scale (p<0.05) based on five questions. Consequently, it was erroneous to conclude differences. Therefore, the Syndrome Model was created. SEM could not have tested the ACR previously, as it comprised a single data point. Thus, it was combined with these three questionnaires, increasing the data points, to create this new measurable model. Results confirmed no significant differences between groups (p=0.07 (p<0.05)).ConclusionParticipants responded in a similar manner to the questionnaire, confirming the same symptom experience. It is important to consider this in context with differing criteria and management guidelines, as this may influence diagnosis and the trajectory of patient’s management. With the biomedical cause currently unclear, it is the symptom experience and the impact on quality of life that is important. These findings are meaningful for patients, clinicians and policy development and support the requirement for future research.

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