scholarly journals An integrated behavioural intervention combined with varenicline for heavy-drinking smokers: a randomized pilot study

2020 ◽  
Vol 15 (3) ◽  
pp. 119-127
Author(s):  
Lisa M. Fucito ◽  
Ran Wu ◽  
Stephanie S. O'Malley ◽  
Tess H. Hanrahan ◽  
Jolomi T. Ikomi ◽  
...  
Keyword(s):  
Pilot Study ◽  
Pilot Trial ◽  
Heavy Drinking ◽  
Medium Effect ◽  
Behavioural Intervention ◽  
Open Label ◽  
Academic Medical Centre ◽  
Academic Medical ◽  
Medium Effect Size ◽  
Promote Smoking Cessation

AbstractObjectivesCombined smoking and heavy drinking is a significant health burden. Varenicline, an efficacious tobacco pharmacotherapy that also shows promise for drinking, has yielded mixed results among heavy-drinking smokers. This pilot study investigated integrated tobacco and alcohol counselling plus varenicline for this vulnerable group.DesignTwelve-week parallel, randomized controlled pilot trial of two behavioural interventions in combination with open-label varenicline. Participants were randomized using computer-generated tables, stratified by sex.SettingOutpatient academic medical centre research clinic.ParticipantsVolunteers who reported smoking and heavy drinking and sought tobacco or alcohol treatment (N = 26).Intervention(1) Integrated tobacco + alcohol counselling (INT; n = 13) or (2) counselling focused on their presenting concern (i.e., tobacco or alcohol) (SINGLE; n = 13), plus varenicline (2 mg) for 12 weeks.Main outcomesFeasibility/acceptability, smoking quit rates and heavy drinking.ResultsINT feasibility/acceptability was high among men but not women. More participants quit smoking in INT than SINGLE. This outcome was only in men, not significant, but had a medium effect size. Both conditions yielded significant drinking reductions.ConclusionIntegrated tobacco and alcohol behavioural counselling plus varenicline may be feasible and promote smoking cessation among men who smoke and drink heavily, but a larger sample is needed to replicate this finding.

scholarly journals A Dietary Mobile App for Patients Undergoing Hemodialysis: Prospective Pilot Study to Improve Dietary Intakes

10.2196/17817 ◽  
2020 ◽  
Vol 22 (7) ◽  
pp. e17817
Author(s):  
Cosette Fakih El Khoury ◽  
Rik Crutzen ◽  
Jos M G A Schols ◽  
Ruud J G Halfens ◽  
Mirey Karavetian
Keyword(s):  
Health Care ◽  
Pilot Study ◽  
Effect Size ◽  
Mobile App ◽  
Dietary Guidelines ◽  
Medium Effect ◽  
Dietary Intakes ◽  
Large Effect Size ◽  
Prospective Pilot Study ◽  
Medium Effect Size

Background Mobile technology has an impact on the health care sector, also within dietetics. Mobile health (mHealth) apps may be used for dietary assessment and self-monitoring, allowing for real-time reporting of food intakes. Changing eating behaviors is quite challenging, and patients undergoing hemodialysis, particularly, struggle to meet the target intakes set by dietary guidelines. Usage of mobile apps that are developed in a person-centered approach and in line with recommendations may support both patients and health care practitioners. Objective This study is a pilot that aims at estimating the potential efficacy of a dietary intervention using a theory-based, person-centered smartphone app. Results will be used to improve both the app and a planned large-scale trial intended to assess app efficacy thoroughly. Methods A prospective pilot study was performed at the hemodialysis unit of Al Qassimi Hospital (The Emirate of Sharjah). All patients that fulfilled the study inclusion criteria were considered eligible to be enrolled in the pilot study. Upon successful installation of the app, users met with a dietitian once a week. Outcomes were measured at baseline (T0) and 2 weeks post app usage (T1). This pilot is reported as per guidelines for nonrandomized pilot and feasibility studies and in line with the CONSORT 2010 checklist for reporting pilot or feasibility trials. Results A total of 23 patients completed the pilot intervention. Mean energy intakes increased from 24.4 kcal/kg/day (SD 8.0) to 29.1 kcal/kg/day (SD 7.8) with a medium effect size (d=0.6, 95% CI 0.0-1.2). Mean protein intakes increased from 0.9 g/kg/day (SD 0.3) to 1.3 g/kg/day (SD 0.5) with a large effect size (d=1.0, 95% CI 0.4-1.6); mean intake of high biological value (%HBV) proteins also increased from 58.6% (SD 10.1) to 70.1% (SD 10.7) with a large effect size (d=1.1, 95% CI 0.5-1.7). Dietary intakes of minerals did not change, apart from sodium which decreased from a mean intake of 2218.8 mg/day (SD 631.6) to 1895.3 mg/day (SD 581.0) with a medium effect size (d=0.5, 95% CI 0.1-1.1). Mean serum phosphorus, potassium, and albumin levels did not change relevantly. Mean serum iron increased from 7.9 mg/dL (SD 2.8) to 11.5 mg/dL (SD 7.9) postintervention with a medium effect size (d=0.6, 95% CI 0.0-1.2). Conclusions This pilot study showed that the KELA.AE app has the potential to improve dietary intakes. Processes related to procedure, resources, tools, and app improvement for a future trial were assessed. A more extended intervention using a randomized controlled trial is required to estimate parameters concerning app efficacy accurately.

scholarly journals P492 The UC Diet and Antibiotics for Treatment of Mild to Moderate Pediatric Ulcerative Colitis: A prospective open label pilot study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S476-S477
Author(s):  
C Sarbagili Shabat ◽  
L Albenberg ◽  
J Van Limbergen ◽  
A Otley ◽  
M Yaakov ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Pilot Study ◽  
Clinical Remission ◽  
Activity Index ◽  
Pilot Trial ◽  
Open Label ◽  
Intention To Treat ◽  
Alternative Therapeutic Approach ◽  
Stable Maintenance ◽  
Steroid Sparing

Abstract Background Strategies that target the microbiome may offer an alternative therapeutic approach for Ulcerative Colitis (UC). The goal of the pilot trial was to evaluate the efficacy of a novel microbe-directed UC diet (UCD) for clinical remission, as well as use of antibiotics for dietary refractory patients as an alternative strategy for remission. Methods This was a prospective, single arm, open label, pilot study in patients aged 8–19, with a pediatric UC activity index (PUCAI) scores >10 on stable maintenance therapy. Patients failing to enter remission (PUCAI<10) on diet could receive a 14-day course of Amoxycillin, Metronidazole and Doxycycline (AMD), and were re-assessed on day 21. The primary endpoint was intention to treat (ITT) remission at week 6 with UCD. Results Twenty-four UCD treatment courses were given to 23 eligible children (mean age 15.3±2.9 years). Median PUCAI decreased from baseline 35 (30–40) to 12.5 (5–27.5) week 6 (P=0.001). Clinical remission with UCD alone was achieved in 9/24 (37.5%). Median calprotectin declined from baseline 818 (630.0–1880.0) to 592.0 (140.7–902.4) week 6. Eight patients received treatment with antibiotics after failing diet, 4/8 (50.0%) subsequently entered remission 3 weeks later. Conclusion The UC Diet appears to be effective for induction of remission in children with mild to moderate UC suggesting that diet could play a role in the disease. Sequential use of UCD followed by antibiotic therapy needs to be evaluated as a microbiome targeted steroid sparing strategy.

scholarly journals Using objective clinical metrics to understand the relationship between the electronic health record and physician well-being: observational pilot study

BJPsych Open ◽  
2021 ◽  
Vol 7 (5) ◽  
Author(s):  
Matthew J. Mosquera ◽  
Heather Burrell Ward ◽  
Christopher Holland ◽  
Robert Boland ◽  
John Torous
Keyword(s):  
Pilot Study ◽  
Maslach Burnout Inventory ◽  
Well Being ◽  
Psychiatry Residents ◽  
Academic Medical Centre ◽  
Academic Medical ◽  
Electronic Health ◽  
Survey Responses ◽  
Attending Physicians

Background Electronic health records (EHRs) are a significant contributor to physicians’ low satisfaction, reduced engagement and increased burnout. Yet the majority of evidence around EHR and physician harms is based on self-reported screen time, which may both over- and underreport actual exposure. Aims The purpose of this study was to examine how objective EHR use correlates with physician well-being and to develop preliminary recommendations for well-being-based EHR interventions. Method Prior to the onset of COVID-19, psychiatry residents and attending physicians working in an out-patient clinic at an academic medical centre provided consent for access to EHR-usage logs and completed a well-being assessment made up of three scales: the Maslach Burnout Inventory, the Urecht Work Engagement Scale and the Professional Quality of Life Measure. Survey responses and objective EHR data were analysed with descriptive statistics. Results Responses were obtained from 20 psychiatry residents (total eligible residents n = 27; 74% participation) and 16 clinical faculty members (total eligible faculty n = 24; 67% participation) with an overall response rate of 71% (total eligible residents and faculty n = 51 and total residents and faculty who completed survey n = 36). Moderate correlations for multiple well-being domains emerged in analysis for all participants, especially around the time spent per note and patient visits closed the same day. Conclusions EHR-usage logs represent an objective tool in the evaluation and enhancement of physician well-being. Results from our pilot study suggest that metrics for note writing efficiency and closing patient visits the same day are associated with physician well-being. These metrics will be important to study in ongoing efforts involving well-being-based EHR interventions.

scholarly journals Additional Therapy with a Mistletoe Product during Adjuvant Chemotherapy of Breast Cancer Patients Improves Quality of Life: An Open Randomized Clinical Pilot Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-9 ◽  
Author(s):  
Wilfried Tröger ◽  
Zdravko Ždrale ◽  
Nevena Tišma ◽  
Miodrag Matijašević
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Pilot Study ◽  
Adjuvant Chemotherapy ◽  
Cancer Patients ◽  
Pilot Trial ◽  
Control Group ◽  
Breast Cancer Patients ◽  
Open Label

Background. Breast cancer patients receiving adjuvant chemotherapy often experience a loss of quality of life. Moreover chemotherapy may induce neutropenia. Patients report a better quality of life when additionally treated with mistletoe products during chemotherapy.Methods. In this prospective randomized open-label pilot study 95 patients were randomized into three groups. All patients were treated with an adjuvant chemotherapy. The primary objective of the study was quality of life, the secondary objective was neutropenia. Here we report the comparison of HxA (n= 34) versus untreated control (n= 31).Results. In the explorative analysis ten of 15 scores of the EORTC QLQ-C30 showed a better quality of life in the HxA group compared to the control group (P<0.001toP=0.038in Dunnett-T3 test). The difference was clinically relevant (difference of at least 5 points, range 5.4–12.2) in eight of the ten scores. Neutropenia occurred in 7/34 HxA patients and in 8/31 control patients (P= 0.628).Conclusions. This pilot study showed an improvement of quality of life by treating breast cancer patients with HxA additionally to CAF. Although the open design may be a limitation, the findings show the feasibility of a confirmatory study using the methods described here.

scholarly journals A Novel UC Exclusion Diet and Antibiotics for Treatment of Mild to Moderate Pediatric Ulcerative Colitis: A Prospective Open-Label Pilot Study

Nutrients ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 3736
Author(s):  
Chen Sarbagili-Shabat ◽  
Lindsey Albenberg ◽  
Johan Van Limbergen ◽  
Naomi Pressman ◽  
Anthony Otley ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Pilot Study ◽  
Clinical Remission ◽  
Activity Index ◽  
Pilot Trial ◽  
Fecal Calprotectin ◽  
Open Label ◽  
Intention To Treat ◽  
Exclusion Diet ◽  
Stable Maintenance

Background: As the microbiome plays an important role in instigating inflammation in ulcerative colitis (UC), strategies targeting the microbiome may offer an alternative therapeutic approach. The goal of the pilot trial was to evaluate the potential efficacy and feasibility of a novel UC exclusion diet (UCED) for clinical remission, as well as the potential of sequential antibiotics for diet-refractory patients to achieve remission without steroids. Methods: This was a prospective, single-arm, multicenter, open-label pilot study in patients aged 8–19, with pediatric UC activity index (PUCAI) scores >10 on stable maintenance therapy. Patients failing to enter remission (PUCAI < 10) on the diet could receive a 14-day course of amoxycillin, metronidazole and doxycycline (AMD), and were re-assessed on day 21. The primary endpoint was intention-to-treat (ITT) remission at week 6, with UCED as the only intervention. Results: Twenty-four UCED treatment courses were given to 23 eligible children (mean age: 15.3 ± 2.9 years). The median PUCAI decreased from 35 (30–40) at baseline to 12.5 (5–30) at week 6 (p = 0.001). Clinical remission with UCED alone was achieved in 9/24 (37.5%). The median fecal calprotectin declined from 818 (630.0–1880.0) μg/g at baseline to 592.0 (140.7–1555.0) μg/g at week 6 (p > 0.05). Eight patients received treatment with antibiotics after failing on the diet; 4/8 (50.0%) subsequently entered remission 3 weeks later. Conclusion: The UCED appears to be effective and feasible for the induction of remission in children with mild to moderate UC. The sequential use of UCED followed by antibiotic therapy needs to be evaluated as a microbiome-targeted, steroid-sparing strategy.

scholarly journals A Dietary Mobile App for Patients Undergoing Hemodialysis: Prospective Pilot Study to Improve Dietary Intakes (Preprint)

2020 ◽  
Author(s):  
Cosette Fakih El Khoury ◽  
Rik Crutzen ◽  
Jos M G A Schols ◽  
Ruud J G Halfens ◽  
Mirey Karavetian
Keyword(s):  
Health Care ◽  
Pilot Study ◽  
Effect Size ◽  
Mobile App ◽  
Dietary Guidelines ◽  
Medium Effect ◽  
Dietary Intakes ◽  
Large Effect Size ◽  
Prospective Pilot Study ◽  
Medium Effect Size

BACKGROUND Mobile technology has an impact on the health care sector, also within dietetics. Mobile health (mHealth) apps may be used for dietary assessment and self-monitoring, allowing for real-time reporting of food intakes. Changing eating behaviors is quite challenging, and patients undergoing hemodialysis, particularly, struggle to meet the target intakes set by dietary guidelines. Usage of mobile apps that are developed in a person-centered approach and in line with recommendations may support both patients and health care practitioners. OBJECTIVE This study is a pilot that aims at estimating the potential efficacy of a dietary intervention using a theory-based, person-centered smartphone app. Results will be used to improve both the app and a planned large-scale trial intended to assess app efficacy thoroughly. METHODS A prospective pilot study was performed at the hemodialysis unit of Al Qassimi Hospital (The Emirate of Sharjah). All patients that fulfilled the study inclusion criteria were considered eligible to be enrolled in the pilot study. Upon successful installation of the app, users met with a dietitian once a week. Outcomes were measured at baseline (T0) and 2 weeks post app usage (T1). This pilot is reported as per guidelines for nonrandomized pilot and feasibility studies and in line with the CONSORT 2010 checklist for reporting pilot or feasibility trials. RESULTS A total of 23 patients completed the pilot intervention. Mean energy intakes increased from 24.4 kcal/kg/day (SD 8.0) to 29.1 kcal/kg/day (SD 7.8) with a medium effect size (<i>d</i>=0.6, 95% CI 0.0-1.2). Mean protein intakes increased from 0.9 g/kg/day (SD 0.3) to 1.3 g/kg/day (SD 0.5) with a large effect size (<i>d</i>=1.0, 95% CI 0.4-1.6); mean intake of high biological value (%HBV) proteins also increased from 58.6% (SD 10.1) to 70.1% (SD 10.7) with a large effect size (<i>d</i>=1.1, 95% CI 0.5-1.7). Dietary intakes of minerals did not change, apart from sodium which decreased from a mean intake of 2218.8 mg/day (SD 631.6) to 1895.3 mg/day (SD 581.0) with a medium effect size (<i>d</i>=0.5, 95% CI 0.1-1.1). Mean serum phosphorus, potassium, and albumin levels did not change relevantly. Mean serum iron increased from 7.9 mg/dL (SD 2.8) to 11.5 mg/dL (SD 7.9) postintervention with a medium effect size (<i>d</i>=0.6, 95% CI 0.0-1.2). CONCLUSIONS This pilot study showed that the KELA.AE app has the potential to improve dietary intakes. Processes related to procedure, resources, tools, and app improvement for a future trial were assessed. A more extended intervention using a randomized controlled trial is required to estimate parameters concerning app efficacy accurately.

scholarly journals Electronic cigarettes as a harm reduction strategy among patients with COPD: protocol for an open-label two arm randomized controlled pilot trial

2022 ◽  
Vol 17 (1) ◽  
Author(s):  
Elizabeth R. Stevens ◽  
Lei Lei ◽  
Charles M. Cleland ◽  
Mahathi Vojjala ◽  
Omar El-Shahawy ◽  
...  
Keyword(s):  
Smoking Cessation ◽  
Pilot Study ◽  
Harm Reduction ◽  
Electronic Cigarettes ◽  
Pilot Trial ◽  
Unmet Need ◽  
Open Label ◽  
Reduction Strategy ◽  
Randomized Controlled ◽  
Harm Reduction Strategy

Abstract Background Smoking cessation is the most effective means of slowing the decline of lung function associated with chronic obstructive pulmonary disease (COPD). While effective smoking cessation treatments are available, they are underutilized and nearly half of people with COPD continue to smoke. By addressing both nicotine and behavioral dependence, electronic cigarettes (EC) could help people with COPD reduce the harm of combustible cigarettes (CC) through reductions in number of Cigarettes per Day (CPD) or quitting CC completely. The purpose of this pilot study is to identify barriers and facilitators to the use of and assess the preliminary effectiveness of EC as a harm reduction strategy among people with COPD. Methods In an open-label two-arm randomized controlled trial pilot study, 60 patients identified as smokers with a COPD diagnosis via electronic health records from a large urban health center are randomized in a 1:1 ratio to either standard care [counseling + nicotine replacement therapy (NRT)] or counseling + EC. The NRT arm will receive nicotine patches and nicotine lozenges for 12 weeks. The EC arm will receive EC for 12 weeks. Both cohorts will receive counseling from a licensed mental health counselor. Using ecological momentary assessment, participants will report their use of CC in both arms and EC use in the EC arm daily via text message. Primary outcomes will be feasibility and acceptability of intervention, and secondary outcomes will be reduction in CPD and change in COPD symptoms as measured by COPD Assessment Tool (CAT) score at 12-weeks. EC displacement of CC. To explore attitudes towards the use of EC as a harm-reduction strategy for patients with COPD, interviews will be performed with a sample of participants from both study arms. Discussion Despite decades of availability of smoking cessation medications, nearly half of people with COPD still smoke. This study aims to address the unmet need for feasible and effective strategies for reducing CC use among those with COPD, which has the potential to significantly improve the health of people with COPD who smoke. Trial Registration ClinicalTrials.gov Identifier: NCT04465318.

Role of GERD in chronic resistant sinusitis (CRS): Results of a prospective, open-label pilot trial

2001 ◽  
Vol 120 (5) ◽  
pp. A425-A425
Author(s):  
B OLUSOLA ◽  
J DIBAISE ◽  
J HUERTER ◽  
E QUIGLEY
Keyword(s):  
Pilot Trial ◽  
Open Label
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