scholarly journals Chemotherapy-induced peripheral neuropathy detection via smartphone app in a cross-sectional pilot study (Preprint)

2021 ◽  
Author(s):  
Ciao-Sin Chen ◽  
Judy Kim ◽  
Harsha Guntupalli ◽  
Noemi Garg ◽  
Reshma Jagsi ◽  
...  

BACKGROUND Severe chemotherapy-induced peripheral neuropathy (CIPN) can cause long-term dysfunction of the hands and feet, interfere with activities of daily living, and diminish quality of life. Monitoring to identify CIPN before it progresses to life-altering severity relies on patients self-reporting subjective symptoms to their clinical team. Objective assessment is not a standard component of CIPN monitoring due to the requirement for specially trained healthcare professionals and equipment. Smartphone apps have the potential to conveniently collect both subjective and objective CIPN data directly from patients, which could improve CIPN monitoring. OBJECTIVE The objective of this cross-sectional pilot study was to assess the feasibility of functional CIPN assessment via smartphone app. METHODS Twenty-six patients who had completed neurotoxic chemotherapy were enrolled and classified as CIPN cases (n=16) or controls (n=10) based on self-report symptoms. All participants completed CIPN assessments within the NeuroDetect app a single time including patient-reported surveys (CIPN20 and PRO-CTCAE) and functional assessments (Gait and Balance and 9 Hole Peg Test). RESULTS Exploratory comparisons between CIPN cases and controls indicate CIPN cases had shorter step length (P=.003), unique swaying acceleration patterns during a walking task, and shorter hand moving distance during a manual dexterity task. CONCLUSIONS Our results confirm that remote CIPN assessment via a smartphone app is feasible and suggest that functional data may be indicative of CIPN manifestations in the hands and feet. Additional work is needed to determine which functional assessments are most indicative of CIPN and could be used for CIPN monitoring within clinical care.

10.2196/27502 ◽  
2021 ◽  
Author(s):  
Ciao-Sin Chen ◽  
Judy Kim ◽  
Harsha Guntupalli ◽  
Noemi Garg ◽  
Reshma Jagsi ◽  
...  

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 176-176
Author(s):  
Daniel Louis Hertz ◽  
Ciao-Sin Chelsea Chen ◽  
Judith Louis Kim ◽  
Harsha Guntupalli ◽  
Michael Dorsch ◽  
...  

176 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a common side effect that manifests in the hands or feet primarily as numbness or tingling but can also have motor or painful components. CIPN monitoring is typically conducted by patients self-reporting symptoms during appointments or via questionnaires. Objective CIPN testing may improve early detection but is not typical during treatment, perhaps due to the need for specialized equipment and personnel. The objective of this pilot study was to conduct initial testing of a smartphone app that collects patient-reported and objective CIPN data. Methods: NeuroDetect V1.0 (available in iOS app store) includes a patient-reported CIPN questionnaire (EORTC CIPN20) and two functional assessments available within ResearchKit, the Gat and Balance and 9-Hole Peg tests. Patients who had completed neurotoxic chemotherapy were enrolled to complete NeuroDetect assessments one time. Study participants were classified as CIPN cases if they answered ≥ 3 for at least one of the first four CIPN20 questions, which ask about numbness or tingling in the hands or feet on a 1-4 scale. User acceleration data features were extracted with two open source tools, mhealthtools and pdkit. The results of the functional assessments were compared between CIPN cases and controls in principal component analysis and partial least squares discriminant analysis. Results: Twenty-four patients who had completed neurotoxic chemotherapy enrolled and completed the NeuroDetect assessments. Integration across all 87 features measured in the gait and balance test explained 42% of the difference between CIPN cases (n = 14) and controls (n = 10) and 9 individual features were significantly different between cases and controls (all p < 0.05). In the 9-hole Peg Test, hand speed explained 77% of the difference between CIPN cases and controls. CIPN cases took longer to complete the 9-hole peg test though the difference was not statistically significant (dominant hand mean 407.3 vs. 406.2 ms, p = 0.075). Conclusions: App-based functional assessment may detect evidence of CIPN. We are developing additional CIPN functional assessments for NeuroDetect V2.0 to test CIPN detection in a longitudinal study of patients undergoing neurotoxic chemotherapy.


2020 ◽  
Vol 47 (2) ◽  
pp. 107-115
Author(s):  
Elizabeth Bradley ◽  
Andrew Shelton ◽  
Trevor Hodge ◽  
David Morris ◽  
Hilary Bekker ◽  
...  

Objective: To measure patient-reported impact of orthodontic treatment in terms of pre-treatment concerns, treatment experience and treatment outcome. Setting: Four sites in Yorkshire, including two secondary care settings (Leeds Dental Institute and St Luke’s Hospital, Bradford) and two specialist orthodontic practices. Design: Cross-sectional survey. Participants: NHS orthodontic patients (aged 12+ years) who have completed comprehensive orthodontic treatment, excluding orthognathic surgery and craniofacial anomalies. Methods: Participants were opportunistically identified by the direct clinical care team during scheduled appointments and those eligible were invited to participate. Data were collected using the Orthodontic Patient Treatment Impact Questionnaire (OPTIQ), a validated 12-item measure with questions relating to pre-treatment experience, impact of treatment and outcome from treatment. Results: Completed questionnaires for analysis included 120 from primary care and 83 from secondary care. The most common pre-treatment concerns were alignment (89%) and being embarrassed to smile (63%). The most common expectations from orthodontic treatment were improved confidence to eat (87%) and smile (72%) in front of others, improved appearance of teeth (85%) and reduced teasing/bullying (63%). Only 67% respondents recalled receiving written information and the lowest recall related to retainer type and length of retention. The most commonly reported complications were sore mouth (68%), fixed appliance breakage (61%) and gingivitis (39%). Treatment caused greatest impact in relation to pain, limitations in eating and effect on speech. Overall satisfaction with orthodontic treatment was reported by 96% of respondents, 87% would have orthodontic treatment again (if needed) and 91% would recommend treatment to a friend. Conclusions: The OPTIQ is a useful patient-reported tool to identify pre-treatment concerns and expectations, treatment experience and outcome. Orthodontic treatment leads to high levels of satisfaction.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 5541-5541
Author(s):  
Ainhoa Madariaga ◽  
Sandra A. Mitchell ◽  
Tyler Pittman ◽  
Lisa Wang ◽  
Valerie Bowering ◽  
...  

5541 Background: A 4 month improvement in OS was demonstrated when Wee1 inhibitor adavosertib (Ad) and gemcitabine (G; arm A) was compared to G and placebo (P; arm B) in a phase 2 trial in recurrent ovarian cancer (NCT02151292). The patient reported outcome version of the CTCAE (PRO-CTCAE) was used to capture self-report of the frequency, severity and/or interference (scored 0-4; higher scores indicating worse symptomatic adverse events [syAEs]). Methods: Ad/P was given orally on D1-2, D8-9, D15-16 with G D1, D8, D15 in a 28-day cycle. English speaking pts in 2 centres completed PRO-CTCAE items electronically in clinic at baseline, D1 and D15 of each cycle and off treatment. An exploratory objective was to characterize syAEs in the first 3 months of therapy. We calculated 12-week area under the curve (AUC12w) as a measure of syAE over time and incremental AUC12w (iAUC12w) for adjustment to baseline syAEs and compared arms A and B using an independent samples t-test. We assessed proportion of scores 3-4 at 6 time-points and compared them using Fisher’s Exact Test at each survey. Results: 51 pts were enrolled and completed ≥1 survey, 47 were evaluable for primary outcome (arm A: 28, B: 19). ECOG status was ≤1 in 44/47 pts. Median number of cycles of therapy were 5 (1-16) in arm A, and 2 (1-16) in B. Survey completion rates were high (arm A 93%, B 95%). Mean AUC12w fatigue severity (A 152 [standard error 9] vs B 112 [10]; p = 0.005) and interference (A 144 [11] vs 98 [15]; p = 0.018), diarrhea frequency (A 70 [12] vs B 33 [9]; p = 0.014), mucositis (A 23 [6] vs B 6 [3]; p = 0.012) and difficulty swallowing severity (A 10 [3] vs B 2 [2]; p = 0.023) were higher in arm A (any grade). There were no statistically significant between-arm differences in abdominal pain, bloating, nausea, vomiting and anxiety. The iAUC12w was significantly higher in arm A vs B for difficulty swallowing severity (A 10.1 [3] vs B -2.7 [4.7]; p = 0.02), mucositis severity (A 19.9 [6.6] vs B -3.1 [6.9]; p = 0.02) and fatigue severity (A 35.2 [8.2] vs B -3.1 [9.8]; p = 0.005). Proportions with high scores (3-4) were only significantly higher at C1D15 for fatigue severity in arm A (A 55% vs B 19%, p = 0.044). No significant differences were seen in other 3-4 scores per survey time. Conclusions: This is the first study evaluating pts self-reported toxicity with adavosertib in a randomized setting, allowing pts self-evaluation of toxicity in the context of improved PFS and OS. Greater fatigue, diarrhea, mucositis and difficulty swallowing were experienced by pts receiving adavosertib and gemcitabine, but score 3-4 reached significance on C1D15 fatigue only. No significant differences were detected in syAE profile for nausea, vomiting, abdominal pain, bloating and anxiety. This approach allows objective assessment of pts perception of toxicity with complex therapy. Clinical trial information: NCT02151292.


2020 ◽  
Vol 3 (11) ◽  
pp. 352-354
Author(s):  
Pooja Gaur

Defined as a rare type I acrocephalosyndactyly syndrome which is clinically characterized by dysmorphic facial features, craniosynostosis, and severe syndactyly of the hands and feet, Apert Syndrome represents an autosomal dominant inheritance which occurs due to the gene mutations in the receptors of the fibroblast growth factor. Oral lesions include tooth crowding, reduction in the size of the maxilla, impacted teeth, anterior open-bite, ectopic eruption, delayed eruption, thick gingiva and supernumerary teeth. The present case report describes a 58 year old female patient reported with the features of Apert’s syndrome such as dysmorphic facial features, occular anomalies, syndactyly and oral features. The case was referred to a specialized centre of clinical care for further treatment.


2019 ◽  
Vol 19 (1) ◽  
Author(s):  
J. H. Fisher ◽  
M. Kolb ◽  
M. Algamdi ◽  
J. Morisset ◽  
K. A. Johannson ◽  
...  

Abstract Background The CAnadian REgistry for Pulmonary Fibrosis (CARE-PF) is a multi-center, prospective registry designed to study the natural history of fibrotic interstitial lung disease (ILD) in adults. The aim of this cross-sectional sub-study was to describe the baseline characteristics, risk factors, and comorbidities of patients enrolled in CARE-PF to date. Methods Patients completed study questionnaires and clinical measurements at enrollment and each follow-up visit. Environmental exposures were assessed by patient self-report and comorbidities by the Charlson Comorbidity Index (CCI). Baseline characteristics, exposures, and comorbidities were described for the overall study population and for incident cases, and were compared across ILD subtypes. Results The full cohort included 1285 patients with ILD (961 incident cases (74.8%)). Diagnoses included connective tissue disease-associated ILD (33.3%), idiopathic pulmonary fibrosis (IPF) (24.7%), unclassifiable ILD (22.3%), chronic hypersensitivity pneumonitis (HP) (7.5%), sarcoidosis (3.2%), non-IPF idiopathic interstitial pneumonias (3.0%, including idiopathic nonspecific interstitial pneumonia (NSIP) in 0.9%), and other ILDs (6.0%). Patient-reported exposures were most frequent amongst chronic HP, but common across all ILD subtypes. The CCI was ≤2 in 81% of patients, with a narrow distribution and range of values. Conclusions CTD-ILD, IPF, and unclassifiable ILD made up 80% of ILD diagnoses at ILD referral centers in Canada, while idiopathic NSIP was rare when adhering to recommended diagnostic criteria. CCI had a very narrow distribution across our cohort suggesting it may be a poor discriminator in assessing the impact of comorbidities on patients with ILD.


2021 ◽  
Author(s):  
Yusuke Takasaki ◽  
Toshio Fujisawa ◽  
Mako Ushio ◽  
Sho Takahashi ◽  
Wataru Yamagata ◽  
...  

Abstract Purpose: Gemcitabine/nab-paclitaxel (GnP) therapy is widely used to treat pancreatic cancer (PC), but chemotherapy-induced peripheral neuropathy (CIPN) is common. Mirogabalin is a novel drug for treating peripheral neuropathy. We investigated the effects of mirogabalin on CIPN due to GnP therapy in PC patients.Methods: This was a single-center retrospective pilot study. Patients who had previously received or were currently receiving GnP for PC and had taken mirogabalin for at least 2 weeks for CIPN, were included. Patients completed a questionnaire about their symptoms before and after taking mirogabalin. The primary outcome was the change in numbness and tingling scores on the patient-reported outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). Secondary outcomes were the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire–Chemotherapy-Induced Peripheral Neuropathy (QLQ-CIPN20) (Japanese version) score, numerical rating scale (NRS) pain score, and adverse events (AEs).Results: Increased numbness and tingling severity (1.84 vs. 1.76; P=0.63) and interference with daily life (1.42 vs. 1.44; P=0.80) were not seen in any of the 25 enrolled patients. The scores on the sensory subscale of the QLQ-CIPN improved significantly after treatment (17.5 vs. 15.7; P=0.02). AEs occurred in 22 patients (88%), but there were no serious AEs (≥ grade 3).Conclusions: Mirogabalin may control the progression of CIPN caused by GnP therapy in PC patients, and improved sensory neuropathy significantly in our patients. However, since the incidence of AEs is high, mirogabalin should be used with caution.


BMJ Open ◽  
2018 ◽  
Vol 8 (8) ◽  
pp. e021900 ◽  
Author(s):  
Chatree Chai-Adisaksopha ◽  
Mark W Skinner ◽  
Randall Curtis ◽  
Neil Frick ◽  
Michael B Nichol ◽  
...  

ObjectiveTo assess the psychometric properties of the Patient Reported Outcomes, Burdens and Experiences (PROBE) questionnaire.MethodsThis study was a cross-sectional, multinational study. Participants were enrolled if they were more than 10 years old and people with haemophilia A or B or people without a bleeding disorder. Participants were invited through non-governmental patient organisations in 21 countries between 01/27/2016 and 02/23/2017. The following psychometric properties: missing data, floor and ceiling effects, exploratory factor analysis and internal consistency reliability were examined. A PROBE Score was derived and assessed for its convergent and known groups validity.ResultsThe study analysed the data on 916 participants with median age of 37.0 (IQR 27.0 to 48.0) years, 74.8% male. In the domain assessing patient-reported outcomes (PROs), more than 15% of participants presented a ceiling effect for all items but two, and a floor effect for one item. Factor analysis identified three factors explaining the majority of the variance. Cronbach’s alpha coefficient indicated good internal consistency reliability (0.84). PROBE items showed moderate to strong correlations with corresponding EuroQol five dimension 5-level instrument (EQ-5D-5L) domains. The PROBE Score has a strong correlation (r=0.67) with EQ-5D-5L utility index score. The PROBE Score has a known groups validity among various groups.ConclusionsThe results of this study suggest that PROBE is a valid questionnaire for evaluating PROs in people with haemophilia as well as control population. The known-group property of PROBE will allow its use in future clinical trials, longitudinal studies, health technology assessment studies, routine clinical care or registries. Additional studies are needed to test responsiveness and sensitivity to change.Trial registration numberNCT02439710; Results.


2021 ◽  
Author(s):  
Nida Rattanakrong ◽  
Noppawan Promma ◽  
Chanatsupang Saraboon ◽  
Pooriput Waongenngarm

Abstract ObjectiveThe present study examined the objective and patient-reported measures of physical impairments, sensory disturbance and functional ability between cancer patients with and without chemotherapy-induced peripheral neuropathy (CIPN) symptoms.Methods41 cancer survivors exposed to neurotoxic chemotherapies were conveniently recruited and completed a single cross-sectional assessment of patient-reported outcomes (VAS for pain intensity and ABC scale) and objective assessments (SWM test, TUG test, 5xSTS test, Romberg test with eyes open and eyes closed, 6MWT, and FAB scale).ResultsCancer patients who had undergone chemotherapy with CIPN symptoms did significantly worse in the SWM test, TUG test, 5xSTS test, Romberg test with eyes closed, 6MWT, FAB scale, and ABC scale (p<0.05) when compared with cancer survivors without CIPN symptoms.ConclusionCancer survivors with CIPN symptoms have lower physical performance, sensory perception, and functional ability, which may increase the risk of falling and disability. These findings further emphasize the need for effective rehabilitation and interventions to treat CIPN symptoms and related physical impairment and functional deficits.


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