scholarly journals Development of a Motility Frailty Index in Patients with Gastroparesis

2021 ◽  
Vol 3 (2) ◽  
pp. 78-83
Author(s):  
Jared Winston ◽  
Patricia Guzman Rojas ◽  
Abigail Stocker ◽  
Prateek Mathur ◽  
Douglas Lorenz ◽  
...  
Keyword(s):  
Pilot Study ◽  
Physical Performance ◽  
Performance Measures ◽  
Frailty Index ◽  
Physical Strength ◽  
Upper Gi ◽  
System A ◽  
Gi Symptoms ◽  
Patient Reported ◽  
Gi Motility

Introduction: Patients with symptoms (Sx) of gastrointestinal (GI) motor disorders have limitations in physical strength and mobility. We hypothesized that physical frailty correlated with severity of GI symptoms, and that a motility frailty index (MFI) could be constructed. Patients: We conducted a prospective pilot study on 40 patients, (38 F, 2 M, mean age 39.9 years) with the following diagnoses: 10 with diabetes mellitus and 30 with non-diabetic/idiopathic disorders. Upper and lower GI Sx were quantified using an FDA-compliant, traditional patient-reported outcomes (PRO) system. Methods: Patients underwent a series of physical performance measures involving standing balance (SB), usual walk speed (UW), and chair sit-and-stands (CS). A GI motility frailty index (MFI) was constructed by fitting several models with a combination of physical performance measures and correlating with PRO. Pearson’s correlation compared the constructed index with the GI Sx PRO to construct a GI MFI. Results: The studied patients collectively showed marked limitations in mobility compared with standard performance values with mean (sd) ratios of SB = 0.87 (0.20), UW = 0.45 (0.13), and CS = 0.38 (0.17). Correlations between physical mobility and GI Sx were noted for upper GI Sx (rho = 0.47, p = 0.002) but not for lower GI Sx. Conclusions: In this pilot study of patients with GI motility disorders, we found increased physical limitations on performance-based testing, which had a statistically significant positive correlation with severity of upper GI motor Sx using a standardized PRO system. A motility frailty index has been constructed that may serve as a basis for better quantifying limitations in patient mobility.

scholarly journals CLINICALLY MEANINGFUL CHANGE FOR PHYSICAL PERFORMANCE: PERSPECTIVES OF THE ICFSR TASK FORCE

2019 ◽  
pp. 1-5
Author(s):  
J. Guralnik ◽  
K. Bandeen-Roche ◽  
S.a.r. Bhasin ◽  
S. Eremenco ◽  
F. Landi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Physical Performance ◽  
Performance Measures ◽  
Patient Reported Outcomes ◽  
Task Force ◽  
Meaningful Change ◽  
Patient Reported ◽  
Research Task ◽  
Definition Of ◽  
Clinical Meaningfulness

For clinical studies of sarcopenia and frailty, clinically meaningful outcome measures are needed to monitor disease progression, evaluate efficacy of interventions, and plan clinical trials. Physical performance measures including measures of gait speed and other aspects of mobility and strength have been used in many studies, although a definition of clinically meaningful change in performance has remained unclear. The International Conference on Frailty and Sarcopenia Research Task Force (ICFSR-TF), a group of academic and industry scientists investigating frailty and sarcopenia, met in Miami Beach, Florida, USA in February 2019 to explore approaches for establishing clinical meaningfulness in a manner aligned with regulatory authorities. They concluded that clinical meaningful change is contextually dependent, and that both anchor- based and distribution-based methods of quantifying physical function are informative and should be evaluated relative to patient-reported outcomes. In addition, they identified additional research needed to enable setting criteria for clinical meaningful change in trials.

Assessment of Disability Related to Femoroacetabular Impingement Syndrome by Use of the Patient-Reported Outcome Measure Information System (PROMIS) and Objective Measures of Physical Performance

2017 ◽  
Vol 45 (11) ◽  
pp. 2476-2482 ◽  
Author(s):  
Andrew J. Sheean ◽  
Matthew R. Schmitz ◽  
Catherine L. Ward ◽  
Aaron E. Barrow ◽  
David J. Tennent ◽  
...  
Keyword(s):  
Physical Performance ◽  
Performance Measures ◽  
Femoroacetabular Impingement ◽  
Patient Reported Outcome ◽  
Step Test ◽  
Harris Hip Score ◽  
Objective Measures ◽  
Level Of Evidence ◽  
Femoroacetabular Impingement Syndrome ◽  
Patient Reported

Background: The National Institutes of Health (NIH)–sponsored Patient-Reported Outcomes Measurement System (PROMIS) has been described as a valuable tool for characterizing outcomes among patients with specific musculoskeletal conditions. Additionally, previously proposed objective measures of physical performance among patients with nonarthritic hip abnormalities are costly and not practically incorporated into routine clinical practice. Purpose: (1) To determine the ability of the PROMIS to differentiate between patients with femoroacetabular impingement (FAI) and asymptomatic controls, (2) to determine the effect of FAI on subjects’ completion of timed physical performance measures, and (3) to determine whether associations exist between established patient-reported outcome (PRO) measures and subjects’ completion of physical performance measures. Study Design: Cross-sectional study; Level of evidence, 3. Methods: Twenty-two asymptomatic controls (CON group) and 20 patients with FAI completed multiple activities to assess physical ability: self-selected walking velocity (SSWV), timed stair ascent (TSA), four-square step test (FSST), and sit-to-stand five times test (STS5). All subjects also underwent a battery of PRO questionnaires: Visual Analog Scale for Pain (VAS), Modified Harris Hip Score (mHHS), International Hip Outcome Tool (iHOT-33), Hip Disability and Osteoarthritis Outcome Score (HOOS), and PROMIS. Descriptive analyses were performed and comparisons between groups were made by use of paired t tests with Bonferroni-Holm correction. Spearman’s rank correlation coefficients were used to determine associations between physical performance measures and PRO. The magnitude of differences between groups for each measured variable was calculated by use of Cohen’s d. Results: Significant differences between CON and FAI groups were observed for all hip-specific PRO measures (CON vs FAI for all; HOOS 99.2 vs 42.8, P < .001, iHOT-33 99.0 vs 26.6, P < .001, mHHS 99.6 vs 62.2, P < .001). Similarly, PROMIS scores were significantly different between groups for 8 of 9 tested domains. Patients with FAI demonstrated significant decrements in performance of all tested physical measures compared with asymptomatic controls (CON vs FAI, SSWV: 1.51 vs 1.32 m/s, P = .002; TSA: 3.05 vs 5.92 s, P = .017; FSST: 4.83 vs 8.89 s, P = .006; STS5: CON 5.53 vs FAI 10.75 s, P = .005.) Deficits in activities involving hip flexion—TSA, STS5—were strongly associated ( r < –0.7, P < .001) with increased reports of disability. Conclusion: FAI has a negative effect on patient-reported and objectively measured function. Hip-specific and general measures such as PROMIS, FSST, TSA, and STS5 are responsive to FAI-associated debility and may be used to objectively assess surgical or rehabilitative outcomes.

scholarly journals 62 Is Weight Loss Alone an Appropriate Indication for Urgent Gastroscopy?

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
C Pickard ◽  
S Komolafe
Keyword(s):  
Weight Loss ◽  
Pilot Study ◽  
Positive Finding ◽  
Nice Guidelines ◽  
Endoscopic Findings ◽  
Upper Gi ◽  
Gi Symptoms ◽  
Significant Pathology

Abstract Aim To assess if patients with weight loss alone have significant pathology identified at gastroscopy. Method 94 consecutive Urgent Suspicion of Cancer (USOC) referrals undergoing gastroscopy were studied over a 6-month period. General, and specific upper GI symptoms, as well as endoscopic findings, were recorded. Results 68% of patients were female. 98% of referrals mentioned weight loss, 94.5% of these patients had concurrent symptoms. 77.5% of patients had a positive finding. 5% (n = 5) had a diagnosis of malignancy. Of the 5 diagnosed with malignancy, none had presented with symptoms of weight loss alone. Conclusions Our practice is in accordance with NICE guidelines. Despite perception, OGD for weight loss alone does not occur commonly. In the current COVID-19 pandemic, it is even more important to vet patients appropriately to prevent unnecessary aerosol generating procedures. We cannot extrapolate from this pilot study whether weight loss alone, is a good indicator for detecting upper GI malignancies, though all cases of malignancy had other specific alarm symptoms.

Enterogastric Reflux: an Uncommon Diagnosis Analyzed by Hepatobiliary Imaging

2019 ◽  
Vol 8 (2) ◽  
Author(s):  
Peter Wang
Keyword(s):  
Abdominal Pain ◽  
Digestive Enzymes ◽  
Gallbladder Disease ◽  
Hepatobiliary Scintigraphy ◽  
Hepatobiliary Imaging ◽  
Upper Gi ◽  
Gi Symptoms ◽  
Upper Abdominal ◽  
Enterogastric Reflux

Enterogastric reflux (EGR) is the reflux of bile and digestive enzymes from the small bowel into the stomach. While it is a normal physiologic process in small amounts, excessive reflux and chronic EGR can cause upper GI symptoms often mimicking more common diseases such as gallbladder disease and GERD that often leads to its underdiagnosis. Identifying EGR is significant as it has been associated with the development of gastroesophogeal pathology including gastritis, esophagitis, ulcers, and mucosal metaplasia. This article presents a 22-year-old male with enterogastric reflux causing upper abdominal pain and will discuss the role of hepatobiliary scintigraphy in its diagnosis.

scholarly journals Protocol for a feasibility study of smoking cessation in the surgical pathway before major lung surgery: Project MURRAY

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e036568
Author(s):  
Sebastian T Lugg ◽  
Amy Kerr ◽  
Salma Kadiri ◽  
Alina-Maria Budacan ◽  
Amanda Farley ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Pilot Study ◽  
Thoracic Surgery ◽  
Elective Surgery ◽  
Primary Objective ◽  
Pulmonary Complications ◽  
University Hospitals ◽  
Patient Reported ◽  
Ethical Approval ◽  
Surgical Pathway

IntroductionSmoking prior to major thoracic surgery is the biggest risk factor for development of postoperative pulmonary complications, with one in five patients continuing to smoke before surgery. Current guidance is that all patients should stop smoking before elective surgery yet very few are offered specialist smoking cessation support. Patients would prefer support within the thoracic surgical pathway. No study has addressed the effectiveness of such an intervention in this setting on cessation. The overall aim is to determine in patients who undergo major elective thoracic surgery whether an intervention integrated (INT) into the surgical pathway improves smoking cessation rates compared with usual care (UC) of standard community/hospital based NHS smoking support. This pilot study will evaluate feasibility of a substantive trial.Methods and analysisProject MURRAY is a trial comparing the effectiveness of INT and UC on smoking cessation. INT is pharmacotherapy and a hybrid of behavioural support delivered by the trained healthcare practitioners (HCPs) in the thoracic surgical pathway and a complimentary web-based application. This pilot study will evaluate the feasibility of a substantive trial and study processes in five adult thoracic centres including the University Hospitals Birmingham NHS Foundation Trust. The primary objective is to establish the proportion of those eligible who agree to participate. Secondary objectives include evaluation of study processes. Analyses of feasibility and patient-reported outcomes will take the form of simple descriptive statistics and where appropriate, point estimates of effects sizes and associated 95% CIs.Ethics and disseminationThe study has obtained ethical approval from NHS Research Ethics Committee (REC number 19/WM/0097). Dissemination plan includes informing patients and HCPs; engaging multidisciplinary professionals to support a proposal of a definitive trial and submission for a full application dependent on the success of the study.Trial registration numberNCT04190966.

scholarly journals Malignant Pleural Effusions Impact on Fatigue (IMPE-F): A Prospective Observational Cohort Pilot Study

2021 ◽  
Vol 1 (2) ◽  
pp. 98-104
Author(s):  
Avinash Aujayeb ◽  
Donna Wakefield
Keyword(s):  
Pilot Study ◽  
Health Research ◽  
Patient Reported Outcome ◽  
Pleural Effusions ◽  
Inclusion Criteria ◽  
Malignant Pleural Effusions ◽  
Cancer Related Fatigue ◽  
Patient Reported ◽  
Observational Cohort ◽  
Respondent Fatigue

Introduction: Cancer-related fatigue is well described. Fatigue in patients with a malignant pleural effusion (MPE) has not been directly studied. Methods: A prospective observational cohort pilot study ‘Do Interventions for Malignant Pleural Effusions (MPE) impact on patient reported fatigue levels (IMPE-F study)’ is planned to determine whether pleural interventions reduce fatigue in MPE. Fatigue will be assessed with a validated patient reported outcome measure, FACIT-F. Discussion: MPE-F has funding from Rocket Medical Plc, and is part of a Masters in Clinical Research at Newcastle University. Respondent fatigue will be addressed by the investigators going through the questionnaire with the participants. Inclusion criteria are all patients above 18 years of age with a presumed MPE undergoing a procedure and able to consent. The expected number of participants is 50. Trial registration: The IMPE-F study has Research Ethics Committee (REC) [20/YH/0224] and Health Research Authority (HRA) and Health and Care Research Wales (HCRW) approvals [IRAS project ID: 276451]. The study has been adopted on National Institute for Health Research portfolio [CPMS ID 46430].

scholarly journals 83 A Medication Self-Management Intervention to Improve Medication Adherence For Older People with Multimorbidity: A Pilot Study

2021 ◽  
Vol 50 (Supplement_1) ◽  
pp. i12-i42
Author(s):  
C Yang ◽  
Z Hui ◽  
S Zhu ◽  
X Wang ◽  
G Tang ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Pilot Study ◽  
Older People ◽  
Intervention Group ◽  
Self Management ◽  
Control Group ◽  
Medication Knowledge ◽  
Management Intervention ◽  
Patient Reported

Abstract Introduction Medication self-management support has been recognised as an essential element in primary health care to promote medication adherence and health outcomes for older people with chronic conditions. A patient-centred intervention empowering patients and supporting medication self-management activities could benefit older people. This pilot study tested a newly developed medication self-management intervention for improving medication adherence among older people with multimorbidity. Method This was a two-arm randomised controlled trial. Older people with multimorbidity were recruited from a community healthcare centre in Changsha, China. Participants were randomly allocated to either a control group receiving usual care (n = 14), or to an intervention group receiving three face-to-face medication self-management sessions and two follow-up phone calls over six weeks, targeting behavioural determinants of adherence from the Information-Motivation-Behavioural skills model (n = 14). Feasibility was assessed through recruitment and retention rates, outcome measures collection, and intervention implementation. Follow-up data were measured at six weeks after baseline using patient-reported outcomes including medication adherence, medication self-management capabilities, treatment experiences, and quality of life. Preliminary effectiveness of the intervention was explored using generalised estimating equations. Results Of the 72 approached participants, 28 (38.89%) were eligible for study participation. In the intervention group, 13 participants (92.86%) completed follow-up and 10 (71.42%) completed all intervention sessions. Ten participants (71.42%) in the control group completed follow-up. The intervention was found to be acceptable by participants and the intervention nurse. Comparing with the control group, participants in the intervention group showed significant improvements in medication adherence (β = 0.26, 95%CI 0.12, 0.40, P &lt; 0.001), medication knowledge (β = 4.43, 95%CI 1.11, 7.75, P = 0.009), and perceived necessity of medications (β = −2.84, 95%CI -5.67, −0.01, P = 0.049) at follow-up. Conclusions The nurse-led medication self-management intervention is feasible and acceptable among older people with multimorbidity. Preliminary results showed that the intervention may improve patients’ medication knowledge and beliefs and thus lead to improved adherence.

scholarly journals Safety and efficacy of faecal microbiota transplantation by Anaerobic Cultivated Human Intestinal Microbiome (ACHIM) in patients with systemic sclerosis: study protocol for the randomised controlled phase II ReSScue trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e048541
Author(s):  
Anna-Maria Hoffmann-Vold ◽  
Håvard H Fretheim ◽  
Vikas K Sarna ◽  
Imon Barua ◽  
Maylen N Carstens ◽  
...  
Keyword(s):  
Systemic Sclerosis ◽  
Pilot Study ◽  
Phase Ii ◽  
Intestinal Microbiome ◽  
Induction Phase ◽  
Inflammatory Disorder ◽  
Faecal Microbiota ◽  
Safety And Efficacy ◽  
Faecal Microbiota Transplantation ◽  
Patient Reported

IntroductionIn the multisystem inflammatory disorder systemic sclerosis (SSc), gastrointestinal tract (GIT) affliction is highly prevalent. There are no known disease modifying therapies and the negative impact is substantial. Aiming for a new therapeutic principle, and inspired by recent work showing associations between gut microbiota changes and GIT symptoms in SSc, we performed a pilot study on faecal microbiota transplantation (FMT) with the single-donor bacterial culture ‘Anaerobic Cultivated Human Intestinal Microbiome (ACHIM)’. Motivated by positive pilot study signals, we designed the ReSScue trial as a phase II multicentre, placebo-controlled, randomised 20-week trial to evaluate safety and efficacy on lower GIT symptoms of FMT by ACHIM in SSc.Methods and analysesWe aim to include 70 SSc participants with moderate to severe lower GIT symptoms, defined by the validated patient-reported University of California Los Angeles Scleroderma Clinical Trial Consortium GIT 2.0 2.0 questionnaire. The trial includes three parts. In part A1 (induction phase) lasting from week 0 to week 12, participants will be randomised 1:1 to repeat infusions of 30 mL ACHIM or placebo at week 0 and 2 by gastroduodenoscopy. In part A2, which is an 8-week subsequent maintenance phase, all study participants will receive 30 mL ACHIM at week 12 and followed until week 20 on continued blind. In part B, which will last until the last participant completes part A2, the participants will be followed through a maximum 16-week extended monitoring period, for longer-term data on safety and intervention effects. Primary endpoint is change from baseline to week 12 in UCLA GIT subscale scores of diarrhoea or bloating, depending on the worst symptom at baseline evaluated separately for each patient. Secondary endpoints are safety measures and changes in UCLA GIT scores (total, diarrhoea and bloating).Ethics and disseminationThis protocol was approved by the Northern Norwegian Committee for Medical Ethics. Study findings will be published.Trial registration numberNCT04300426; Pre-results.Protocol versionV.3.1.

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