scholarly journals Breathalyser-Based eHealth Data Suggest That Self-Reporting of Abstinence Is a Poor Outcome Measure for Alcohol Use Disorder Clinical Trials

2020 ◽  
Vol 55 (3) ◽  
pp. 237-245 ◽  
Author(s):  
Markku D Hämäläinen ◽  
Andreas Zetterström ◽  
Maria Winkvist ◽  
Marcus Söderquist ◽  
Patrik Öhagen ◽  
...  

Abstract Aims To evaluate the efficacy and monitoring capabilities of a breathalyser-based eHealth system for patients with alcohol use disorder (AUD) and to investigate the quality and validity of timeline follow-back (TLFB) as outcome measure in clinical trials and treatment. Methods Patients (n = 115) were recruited to clinical trials from a 12-step aftercare programme (12S-ABS) and from hospital care with abstinence (HC-ABS) or controlled drinking (HC-CDR) as goal and randomly divided into an eHealth and a control group. The effect of the eHealth system was analysed with TLFB-derived primary outcomes—change in number of abstinent days (AbsDay) and heavy drinking days (HDDs) compared to baseline—and phosphatidyl ethanol (PEth) measurements. Validity and quality of TLFB were evaluated by comparison with breath alcohol content (BrAC) and eHealth digital biomarkers (DBs): Addiction Monitoring Index (AMI) and Maximum Time Between Tests (MTBT). TLFB reports were compared to eHealth data regarding reported abstinence. Results The primary outcome (TLFB) showed no significant difference between eHealth and control groups, but PEth did show a significant difference especially at months 2 and 3. Self-reported daily abstinence suffered from severe quality issues: of the 28-day TLFB reports showing full abstinence eHealth data falsified 34% (BrAC measurements), 39% (MTBT), 54% (AMI) and 68% (BrAC/MTBT/AMI). 12S-ABS and HC-ABS patients showed severe under-reporting. Conclusions No effect of the eHealth system was measured with TLFB, but a small positive effect was measured with PEth. The eHealth system revealed severe quality problems with TLFB, especially regarding abstinence—should measurement-based eHealth data replace TLFB as outcome measure for AUD?

2013 ◽  
Vol 2 (2) ◽  
pp. 49-53
Author(s):  
Fatemeh Bahramnezhad ◽  
Ahmad Ali Asadi Noughabi ◽  
Pouya Farokhnezhad Afshar ◽  
Simin Marandi

Background: Guidelines recommend that exercise training can beconsidered for medically stable outpatients with heart failure; thus, this study sought to determine the effect of exercise on quality of life in patients with heart failure.Patients and Methods: In this cross sectional study 160 patients were included and divided into 2 groups (n=80). Intervention group performed the exercise (poly striding), 30 minutes three times a week, for 8 weeks. After 8 weeks, the exercises have not been followed for six months; SF36 Questionnaire was filled to assess the quality of life for the individuals in both groups in three steps: before the intervention, and 3 and 6 months after. After completion of questionnaires, quality of life was compared between the two groups and all the data were analyzed using descriptive and inferential statistics.Results: The mean ages of the intervention and control groups were 61.65±17.5 and 64.116±17.4 years, respectively. Control group had significant decrease in quality of life at different stages of the study. Quality of life was significantly better in the intervention group comparing to the control group three months after the intervention despite the lack of significant difference before the intervention and after 6 months.Conclusion: Results showed a positive effect of exercise on quality of life in patients but the failures and lack of continuity did not improve the overall quality of life of patients as compared with their condition before the exercise. Overall, regular exercise is recommended for these patients.


2018 ◽  
Vol 47 (4) ◽  
pp. 462-468 ◽  
Author(s):  
Kurt Jensen ◽  
Charlotte Nielsen ◽  
Claus Thorn Ekstrøm ◽  
Kirsten K. Roessler

Aim: The aim of this study is to compare the effect of exercise training on physical capacity and alcohol consumption in alcohol use disorder (AUD) patients. Methods: One hundred and five AUD patients were randomly assigned to treatment as usual combined with running and brisk walking for 30–45 min twice a week, either in small supervised groups (GR) or individually (IND), or to a control group with no running (C). Assessments were made after 6 and 12 months of training. Results: Training volume was estimated as 36 min per training bout at an intensity of 78% of HRmax with no differences between GR and IND ( p>.05). A highly significant reduction in training frequency was seen in both training groups after the first month ( p<.0001). Only IND increased VO2max, by 5.7% ( p<.05), while no differences were seen between GR, IND and C. Alcohol intake decreased from 219 to 41 units per 30 days as the average for the entire sample with no significant difference of drinking outcomes between groups ( p<.0001). Conclusions: We saw an effect on drinking habits after running in both groups. However, no additional effect was seen when compared with the control group. A drop in the training frequency during the intervention might have resulted in an insignificant training stimulus.


2021 ◽  
pp. 1-12
Author(s):  
Conor Farren ◽  
Aoife Farrell ◽  
Aisling Hagerty ◽  
Cliodhna McHugh

<b><i>Background and Aims:</i></b> Alcohol use disorder (AUD) is a substantial problem, causing early death and great economic burden. Research has highlighted the potential positive impact of technological interventions, such as smartphone applications (app) in treatment of AUD. The aim of this study was to explore the effectiveness of a smartphone app, incorporating computerized cognitive behavioural therapy and text messaging support, on alcohol outcomes over 6 months in a post-rehabilitation setting. <b><i>Methods:</i></b> A total of 111 participants with AUD were recruited into this randomized controlled trial, following completion of a 30-day rehabilitation programme. The intervention group (<i>n</i> = 54) used the smartphone app “UControlDrink” (UCD) over 6 months with treatment as usual (TAU), and the control group (<i>n</i> = 57) received TAU. All subjects suffered from AUD as the primary disorder, with other major psychiatric disorders excluded. All intervention subjects used the UCD smartphone app in the treatment trial, and all subjects underwent TAU consisting of outpatient weekly support groups. Drinking history in the previous 90 days was measured at baseline and at 3- and 6-month follow-ups. Additional measurements were made to assess mood, anxiety, craving, and motivation. Results were analysed using intention-to-treat analyses. <b><i>Results:</i></b> Retention in the study was 72% at 3 months and 52% at 6 months. There was a significant reduction in heavy drinking days in the intervention group relative to TAU over the 6 months, <i>p</i> &#x3c; 0.02. <b><i>Conclusions:</i></b> The UCD smartphone app demonstrates a significant benefit to reducing heavy drinking days over a 6-month post-rehabilitation period in AUD.


2004 ◽  
Vol 122 (6) ◽  
pp. 252-258 ◽  
Author(s):  
Tathiana Pagano ◽  
Luciana Akemi Matsutani ◽  
Elisabeth Alves Gonçalves Ferreira ◽  
Amélia Pasqual Marques ◽  
Carlos Alberto de Bragança Pereira

CONTEXT: Fibromyalgia is a syndrome characterized by chronic, diffuse musculoskeletal pain, and by a low pain threshold at specific anatomical points. The syndrome is associated with other symptoms such as fatigue, sleep disturbance, morning stiffness and anxiety. Because of its chronic nature, it often has a negative impact on patients' quality of life. OBJECTIVE: To assess the quality of life and anxiety level of patients with fibromyalgia. TYPE Of STUDY: Cross-sectional. SETTING: Rheumatology outpatient service of Hospital das Clínicas (Medical School, Universidade de São Paulo). METHODS: This study evaluated 80 individuals, divided between test and control groups. The test group included 40 women with a confirmed diagnosis of fibromyalgia. The control group was composed of 40 healthy women. Three questionnaires were used: two to assess quality of life (FIQ and SF-36) and one to assess anxiety (STAI). They were applied to the individuals in both groups in a single face-to-face interview. The statistical analysis used Student's t test and Pearson's correlation test (r), with a significance level of 95%. Also, the Pearson chi-squared statistics test for homogeneity, with Yates correction, was used for comparing schooling between test and control groups. RESULTS: There was a statistically significant difference between the groups (p = 0.000), thus indicating that fibromyalgia patients have a worse quality of life and higher levels of anxiety. The correlations between the three questionnaires were high (r = 0.9). DISCUSSION: This study has confirmed the efficacy of FIQ for evaluating the impact of fibromyalgia on the quality of life. SF-36 is less specific than FIQ, although statistically significant values were obtained when analyzed separately, STAI showed lower efficacy for discriminating the test group from the control group. The test group showed worse quality of life than did the control group, which was demonstrated by both FIQ and SF-36. Even though STAI was a less efficient instrument, it presented significant results, showing that fibromyalgia patients presented higher levels of anxiety, both on the state and trait scales. Thus, patients with fibromyalgia had higher levels of tension, nervousness, preoccupation and apprehension, and higher propensity towards anxiety. CONCLUSION: The three instruments utilized showed efficiency in evaluating fibromyalgia patients. FIQ was found to be the most efficient instrument for discriminating and assessing the impact of fibromyalgia on their quality of life. It can be concluded that such patients have a worse quality of life and higher levels of anxiety.


2016 ◽  
Vol 8 (11) ◽  
pp. 11 ◽  
Author(s):  
Mahbobeh Sajadi ◽  
Mozhgan Bagheri ◽  
Davood Hekmatpou ◽  
Hamid Borsi

<p><strong>INTRODUCTION:</strong> Asthma is a prevalent disease with a multitude of complication. The present research was aimed at investigating the effects of implementing sensitization care model on medication adherence in asthmatic patients.</p><p><strong>METHODS &amp; MATERIALS:</strong> In this interventional study, 74 subjects were selected using accessibility sampling method and were randomly classified into 2 separate groups, intervention (37 subjects) and control group (37 subjects). Data were collected with questionnaire. A month later, the subjects in both groups (control and intervention) completed questionnaire again. The collected data were analyzed using SPSS software, Independent t-test, Paired t-test and Chi-Square.</p><p><strong>RESULTS:</strong> Data analysis showed that the average age of participants was 41 years (range 21-83). The most and lowest frequencies of marital status in both sexes were 66.2% married and 33.8% single, respectively. There was no significant difference before intervention between two groups. However, after the intervention, there was a significant difference between the two groups (P=0.0001).</p><p><strong>DISCUSSION:</strong> The results of the present study showed that implementing sensitization care model had a positive effect on medication adherence among asthmatic patients. Therefore, application of this model is recommended to care and treatment asthmatic patients.</p>


2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 90-90
Author(s):  
Shadan Pedramrazi

90 Background: Breast cancer is one the most prevalent cancers among Iranian women. One of the complementary therapies is reflexology. The extant paper has been provided with the objective of determining the effect of reflexology on quality of life of patients with breast cancer undergoing chemotherapy in the breast disease center. Methods: This study is a randomized clinical trial which has been applied to 60 patients suffering from breast cancer under chemotherapy in breast diseases center, in 2012. The patients were selected randomly in three test, control and placebo groups. In test group, reflexology was implemented for 3 weeks and each session lasted half an hour. In placebo group, only relaxation techniques were implemented for 3 weeks, each session lasted 20-30 minutes. Control group received the routine therapies of breast cancer center. Results: Data were collected by standard questionnaires of EORTIC QLQ-C30.V.3 and EORTIC QLQ-BR23.V.3. The questionnaires were filled before intervention and two weeks after applying study. There was no significant difference in demographic characteristics or quality of life score of three groups, before intervention. Total score of quality of life was higher in interventional group compared to placebo group before and two weeks after intervention (p < 0.001) Results also indicated a significant difference in total score of quality of life between three test, placebo, and control groups after intervention (p < 0.001). A considerable improvement was noticed in the different aspects of quality of life in the test group compared to two other placebo and control groups. Conclusions: Reduction of pain, anxiety, nausea, and other symptoms related to cancer in patients suffering from cancer are assumed as the important cases of nursing cares focus, and precise nursing may diminish these symptoms considerably. Using reflexology in patients suffering from breast cancer may improve the quality of life as an effective method, and can be recommended for use in patients with breast cancer if it is supervised by health system personnel.


2019 ◽  
Author(s):  
Lauren A. Maggio ◽  
Todd C. Leroux ◽  
Anthony R. Artino

AbstractMany medical education journals use Twitter to garner attention for their articles. The purpose of this study was to test the effects of tweeting on article page views and downloads.The authors conducted a randomized trial usingAcademic Medicinearticles published in 2015. Beginning in February through May 2018, one article per day was randomly assigned to a Twitter (case) or control group. Daily, an individual tweet was generated for each article in the Twitter group that included the title, #MedEd, and a link to the article. The link delivered users to the article’s landing page, which included immediate access to the HTML full text and a PDF link. The authors extracted HTML page views and PDF downloads from the publisher. To assess differences in page views and downloads between cases and controls, a time-centered approach was used, with outcomes measured at 1, 7, and 30 days.In total, 189 articles (94 cases, 95 controls) were analyzed. After days 1 and 7, there were no statistically significant differences between cases and controls on any metric. On day 30, HTML page views exhibited a 63% increase for cases (M=14.72, SD=63.68) when compared to controls (M=9.01, SD=14.34; incident rate ratio=1.63, p=0.01). There were no differences between cases and controls for PDF downloads on day 30.Contrary to the authors’ hypothesis, only one statistically significant difference in page views between the Twitter and control groups was found. These findings provide preliminary evidence that after 30 days a tweet can have a small positive effect on article page views.


2016 ◽  
Vol 9 (2) ◽  
pp. 112 ◽  
Author(s):  
Fereydoon Laal ◽  
Mohammad Jafari Modrek ◽  
Davoud Balarak ◽  
Mahdi Mohammadi ◽  
Mahdieh Rakhshani ◽  
...  

<p>With the development of science and technology, occupational accidents, as one of the most important problems in the world, result in negative effects on physical and psychological health, and also the quality of life of workers. The aim of this study was to compare the quality of life among workers with and without accident. In a cross-sectional study, 93 workers were selected, 31 who experienced accident and 62 as control group. To gather the data, a researcher-made questionnaire for demographic characteristics and the quality of life questionnaire (SF-36) were used. Mann-Whitney and Chi-square tests were used for data analysis. The mean and standard deviation of age was 30.81±7.29 and 30.56±7.19 in workers with accident (case group) and control group, respectively. Homogeneity was ensured in terms of age and work experience and the two groups had no significant difference in this regard (p&gt;0.05). Most of the participants were high school graduates (67.7%). The majority of accidents (68.8%) had occurred in the manufacturing sections. The most common accident type was sprayed chemical substances (19.4%) and the less frequent was electrocution (3.2%). The mean total score for the quality of life was 37.61±14.29 and 74.92±12.95 in the case and control groups with a statistical significance difference (p&lt;0.001). The results of this study indicate that the incident could affect the quality of life of workers. Therefore, promoting the safety culture can help to reduce the occupational accidents.</p>


2018 ◽  
Vol 9 (3) ◽  
pp. 182-184
Author(s):  
Najmeh Amani Babadi ◽  
Masoomeh Kheirkhah ◽  
Faraz Mojab ◽  
Hamid Haghani

Episiotomy is one of the most common midwifery interventions method for preventing injuries to the pelvic floor during the delivery process. Traditional medicine has a special place in improving the quality of postpartum care. Sesame is one of the herbs with anti-inflammatory, anti-bacterial and antioxidant activity.  This study was evaluate the effect of sesame ointment on episiotomy healing. Methods: This randomized control clinical trial was performed on 104 eligible women. The samples were block randomly assigned to one of the groups Intervention and control. Samples were used sesame and placebo ointment for epizootics from 4 hours after delivery for ten days every 8 hours. Clinical evaluation of episiotomy ulcer was performed 4 hours, 7 and 10 days after delivery with using REEDA tool. SPSS software version 16 was used for data analysis. P value less than 0.05 was considered significant. Results: The average of wound healing rate was 7 days after episiotomy in the intervention group 0.09 ± 0.29 and in the control group was 0.73 ± 0.44. Independent t-test showed that the two groups had a significant difference (p <0.001).Healing of the wound 10 days after episiotomy showed that the mean scores in the control group (0.4 ± 0.49) and in the intervention group (0.02 ± 0.13), healing in the intervention group significantly decreased from the control group (p <0.001). Conclusion: Sesame ointment can be used as a pain relief and accelerator for episiotomy healing.  


2020 ◽  
Vol 2020 ◽  
pp. 1-7 ◽  
Author(s):  
Sahar Hamzeh ◽  
Roya Safari-Faramani ◽  
Alireza Khatony

One of the problems of cancer patients is sleep disorder. Given the absence of studies on comparing the effect of inhalation aromatherapy with lavender and peppermint on the sleep quality of the cancer patients, this study was performed to compare the effect of inhalation aromatherapy with lavender and peppermint essential oils on the sleep quality of cancer patients. For this purpose, 120 patients were randomly allocated to three groups of lavender, peppermint, and control. The intervention groups received three drops of the essential oil for 7 days. In the control group, aromatic distilled water was used instead. Pittsburgh Sleep Quality Inventory (PSQI) was used. Before the intervention, no significant difference was observed between the mean PSQI scores of three groups, while the difference was statistically significant after the intervention. The mean PSQI scores were lower in lavender and peppermint groups than in the control group. Aromatherapy can improve the sleep quality of cancer patients. To confirm the findings, more studies should be done.


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