scholarly journals Tailored Web-Based Smoking Interventions and Reduced Attrition: Systematic Review and Meta-Analysis (Preprint)

2019 ◽  
Author(s):  
Amika Shah ◽  
Michael Chaiton ◽  
Dolly Baliunas ◽  
Robert Schwartz
Keyword(s):  
Systematic Review ◽  
Smoking Cessation ◽  
Passive Control ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
The Impact

BACKGROUND The increasing number of internet users presents an opportunity to deliver health interventions to large populations. Despite their potential, many web-based interventions, including those for smoking cessation, face high rates of attrition. Further consideration of how intervention features impact attrition is needed. OBJECTIVE The aim of this systematic review is to investigate whether tailored web-based smoking cessation interventions for smokers are associated with reduced rates of attrition compared with active or passive untailored web-based interventions. The outcomes of interest were dropout attrition at 1-, 3-, 6-, and 12-month follow-ups. METHODS Literature searches were conducted in May 2018 and updated in May 2020 on MEDLINE (Medical Literature Analysis and Retrieval System Online), PsycINFO (Psychological Information), EMBASE (Excerpta Medica dataBASE), CINAHL (Cumulated Index to Nursing and Allied Health Literature), Scopus, and the Cochrane Tobacco Addiction Group Specialized Register with the following search terms: smoking cessation, tailored, or web- or internet-based. Included studies were published in English before or in May 2020 using a randomized controlled trial design. Studies were restricted to those with web-based delivery, a tailored intervention group, an untailored control group, and a reported outcome of smoking cessation. Studies were assessed for methodological quality using the Cochrane Risk of Bias tool. Two reviewers independently extracted the study characteristics and the number of participants lost to follow-up for each treatment group. RESULTS A total of 13 studies were included in the systematic review, of which 11 (85%) were included in the meta-analysis. Tailoring had no statistically significant effect on dropout attrition at 1-month (risk ratio [RR]=1.02, 95% CI 0.95-1.09; <i>P</i>=.58; <i>I</i><sup>2</sup>=78%), 3-month (RR=0.99, 95% CI 0.95-1.04; <i>P</i>=.80; <i>I</i><sup>2</sup>=73%), 6-month (RR=1.00, 95% CI 0.95-1.05; <i>P</i>=.90; <i>I</i><sup>2</sup>=43%), or 12-month (RR=0.97, 95% CI 0.92-1.02; <i>P</i>=.26; <i>I</i><sup>2</sup>=28%) follow-ups. Subgroup analyses suggested that there was a statistically significant effect of tailoring between the active and passive subgroups at 1-month (<i>P</i>=.03), 3-month (<i>P</i>&lt;.001), and 6-month <i>(P</i>=.02) follow-ups but not at 12-month follow-up (<i>P</i>=.25). CONCLUSIONS The results suggest that tailoring of web-based smoking cessation interventions may not be associated with reduced rates of dropout attrition at 1-, 3-, 6-, or 12-month follow-ups. Significant differences between studies that include untailored active and passive control groups suggest that the role of tailoring may be more prominent when studies include a passive control group. These findings may be because of variability in the presence of additional features, the definition of smokers used, and the duration of smoking abstinence measured. Future studies should incorporate active web-based controls, compare the impact of different tailoring strategies, and include populations outside of the Western countries.

scholarly journals Tailored Web-Based Smoking Interventions and Reduced Attrition: Systematic Review and Meta-Analysis

10.2196/16255 ◽  
2020 ◽  
Vol 22 (10) ◽  
pp. e16255
Author(s):  
Amika Shah ◽  
Michael Chaiton ◽  
Dolly Baliunas ◽  
Robert Schwartz
Keyword(s):  
Systematic Review ◽  
Smoking Cessation ◽  
Passive Control ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Intervention Group ◽  
Control Group ◽  
Web Based ◽  
The Impact

Background The increasing number of internet users presents an opportunity to deliver health interventions to large populations. Despite their potential, many web-based interventions, including those for smoking cessation, face high rates of attrition. Further consideration of how intervention features impact attrition is needed. Objective The aim of this systematic review is to investigate whether tailored web-based smoking cessation interventions for smokers are associated with reduced rates of attrition compared with active or passive untailored web-based interventions. The outcomes of interest were dropout attrition at 1-, 3-, 6-, and 12-month follow-ups. Methods Literature searches were conducted in May 2018 and updated in May 2020 on MEDLINE (Medical Literature Analysis and Retrieval System Online), PsycINFO (Psychological Information), EMBASE (Excerpta Medica dataBASE), CINAHL (Cumulated Index to Nursing and Allied Health Literature), Scopus, and the Cochrane Tobacco Addiction Group Specialized Register with the following search terms: smoking cessation, tailored, or web- or internet-based. Included studies were published in English before or in May 2020 using a randomized controlled trial design. Studies were restricted to those with web-based delivery, a tailored intervention group, an untailored control group, and a reported outcome of smoking cessation. Studies were assessed for methodological quality using the Cochrane Risk of Bias tool. Two reviewers independently extracted the study characteristics and the number of participants lost to follow-up for each treatment group. Results A total of 13 studies were included in the systematic review, of which 11 (85%) were included in the meta-analysis. Tailoring had no statistically significant effect on dropout attrition at 1-month (risk ratio [RR]=1.02, 95% CI 0.95-1.09; P=.58; I2=78%), 3-month (RR=0.99, 95% CI 0.95-1.04; P=.80; I2=73%), 6-month (RR=1.00, 95% CI 0.95-1.05; P=.90; I2=43%), or 12-month (RR=0.97, 95% CI 0.92-1.02; P=.26; I2=28%) follow-ups. Subgroup analyses suggested that there was a statistically significant effect of tailoring between the active and passive subgroups at 1-month (P=.03), 3-month (P<.001), and 6-month (P=.02) follow-ups but not at 12-month follow-up (P=.25). Conclusions The results suggest that tailoring of web-based smoking cessation interventions may not be associated with reduced rates of dropout attrition at 1-, 3-, 6-, or 12-month follow-ups. Significant differences between studies that include untailored active and passive control groups suggest that the role of tailoring may be more prominent when studies include a passive control group. These findings may be because of variability in the presence of additional features, the definition of smokers used, and the duration of smoking abstinence measured. Future studies should incorporate active web-based controls, compare the impact of different tailoring strategies, and include populations outside of the Western countries.

scholarly journals Sofosbuvir with daclatasvir and the outcomes of patients with COVID-19: a systematic review and meta-analysis with GRADE assessment

2021 ◽  
pp. postgradmedj-2021-140287
Author(s):  
Ahmad Fariz Malvi Zamzam Zein ◽  
Catur Setiya Sulistiyana ◽  
Wilson Matthew Raffaello ◽  
Arief Wibowo ◽  
Raymond Pranata
Keyword(s):  
Systematic Review ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Invasive Mechanical Ventilation ◽  
Intervention Group ◽  
Control Group ◽  
Reduce Mortality Rate ◽  
Icu Admission ◽  
Clinical Recovery

PurposeThis systematic review and meta-analysis aimed to evaluate the effect of sofosbuvir/daclatasvir (SOF/DCV) on mortality, the need for intensive care unit (ICU) admission or invasive mechanical ventilation (IMV) and clinical recovery in patients with COVID-19.MethodsWe performed a systematic literature search through the PubMed, Scopus and Embase from the inception of databases until 6 April 2021. The intervention group was SOF/DCV, and the control group was standard of care. The primary outcome was mortality, defined as clinically validated death. The secondary outcomes were (1) the need for ICU admission or IMV and (2) clinical recovery. The pooled effect estimates were reported as risk ratios (RRs).ResultsThere were four studies with a total of 231 patients in this meta-analysis. Three studies were randomised controlled trial, and one study was non-randomised. SOF/DCV was associated with lower mortality (RR: 0.31 (0.12, 0.78); p=0.013; I2: 0%) and reduced need for ICU admission or IMV (RR: 0.35 (0.18, 0.69); p=0.002; I2: 0%). Clinical recovery was achieved more frequently in the SOF/DCV (RR: 1.20 (1.04, 1.37); p=0.011; I2: 21.1%). There was a moderate certainty of evidence for mortality and need for ICU/IMV outcome, and a low certainty of evidence for clinical recovery. The absolute risk reductions were 140 fewer per 1000 for mortality and 186 fewer per 1000 for the need for ICU/IMV. The increase in clinical recovery was 146 more per 1000.ConclusionSOF/DCV may reduce mortality rate and need for ICU/IMV in patients with COVID-19 while increasing the chance for clinical recovery.Protocol registrationPROSPERO: CRD42021247510.

Abstract P186: A Randomized Preschool Trial To Promote Cardiovascular Health In Colombia: 18 Month Follow Up.

Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Jaime Céspedes ◽  
German Briceño ◽  
Michael Farkouh ◽  
Rajesh Vedanthan ◽  
Martha Leal ◽  
...  
Keyword(s):  
Educational Intervention ◽  
Cardiovascular Health ◽  
Controlled Trial ◽  
Intervention Group ◽  
Educational Programs ◽  
Control Group ◽  
Active Lifestyle ◽  
And Control ◽  
The Impact

Introduction: Educational programs for children can increase uptake of healthy lifestyle behaviors. However, the impact of educational programs in preschool-aged children in low- and middle-income countries is not known. We conducted a five month educational intervention in preschool facilities (PF) in Bogota, Colombia, to assess changes in preschooler’s knowledge, attitudes and habits (KAH) towards healthy eating and living an active lifestyle. Methods: We conducted a cluster, randomized, controlled trial, and randomly assigned 14 PF in Bogota to a five-month educational intervention (7 PF) or to usual curriculum (7 PF). The intervention included classroom activities and use of printed material and videos. A total of 1216 pre-school children, 928 parents, and 120 teachers participated. A structured survey was used to evaluate changes in KAH with a weighted total score (WTS). The primary outcome was change in children's WTS, and the secondary outcomes were change in parents’ and teachers' WTS. The control PF were provided the intervention after the initial evaluation. To assess sustainability, we evaluated both intervention and control groups at 18 months. Results: At 6 months, children in the intervention group showed 10.9% increase in WTS vs. 5.3% in controls, p<0.001, after adjustment for cluster, sex, age and teachers' educational level. Among parents, the equivalent results were 8.9% and 3.1%, respectively, p< 0.001, and among teachers 9.4% and 2.5%, p=0.06. At the 18-month extended follow-up, both the intervention and control children showed a significant further increase in WTS, p<0.001 (Figure 1). In parents and teachers in the intervened group, there was no significant increase in WTS, p=0.7417, and p=0.1197. In the control group, there was an increase in WTS in teachers but not in parents, p=0.001, and p=0.4239. Conclusion: A preschool based intervention, aimed at changing KAH related to healthy diet and active lifestyle, is feasible, efficacious and sustainable up to 18 months in very young children in Colombia.

scholarly journals Impact of Epley manoeuvre on self-perceived disability: A randomised controlled trial in primary care

2020 ◽  
Author(s):  
Ricard Carrillo Muñoz ◽  
Jose Luis Ballve Moreno ◽  
Ivan Villar Balboa ◽  
Yolanda Rando Matos ◽  
Oriol Cunillera Puertolas ◽  
...  
Keyword(s):  
Primary Care ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Perceived Disability ◽  
Randomised Controlled ◽  
The Impact

Abstract Background: Posterior canal benign paroxysmal positional vertigo (pc-BPPV) causes physical, functional, and emotional impairment. The treatment of choice is the Epley manoeuvre (EM). The purpose of the study was to compare the impact of the EM and a sham manoeuvre in primary care on self-perceived disability.Method: Randomised, double-blind, sham-controlled clinical trial conducted in primary care with a follow-up of 1 year. Patients aged ≥18 years old diagnosed with pc-BPPV according to the Dix-Hallpike test (DHT) were randomised to an intervention (EM) group or a control (sham manoeuvre) group. The main study covariables were age, sex, history of depression and anxiety, presence of nystagmus in the DHT, patient-perceived disability assessed with the Dizziness Handicap Inventory-screening version (DHI-S). Data were analyzed using bivariate and multivariate mixed Tobit analyses. Results: Overall, 134 patients were studied: 66 in the intervention group and 68 in the control group. Median age was 52 years (interquartile range [IQR], 38.25–68.00 years) and 76.12% of the patients were women. The DHT triggered nystagmus in 40.30% of patients. The median total DHI-S score for the overall sample at baseline was 16 (IQR, 8.00–22.00); 16 [IQR, 10.5–24.0] vs 10 [6.0–14.0] for women vs men (P<0.001) and 16 [IQR, 10.0-24.0] vs 12 [IQR, 8.0–18.0] for patients without nystagmus vs those with nystagmus (P=0.033).Patients treated with the EM experienced a mean reduction of 2.03 points in DHI-S score over the follow-up period compared with patients in the sham group. Conclusion: Pc-BPPV affects the quality of life of primary care patients. A single EM can improve self-perceptions of disability by around 2 points on the DHI-S scale, Trial registration: ClinicalTrials.gov Identifier: NCT01969513. Retrospectively registered. First Posted: October 25, 2013. https://clinicaltrials.gov/ct2/show/NCT01969513

scholarly journals Effects of reflexology on premenstrual syndrome: a systematic review and meta-analysis

2019 ◽  
Vol 13 (1) ◽  
Author(s):  
Marzieh Hasanpour ◽  
Mohammad Mehdi Mohammadi ◽  
Habib Shareinia
Keyword(s):  
Systematic Review ◽  
Premenstrual Syndrome ◽  
Treatment Time ◽  
Psychological Symptoms ◽  
Meta Analysis ◽  
Intervention Group ◽  
Care Program ◽  
Cochrane Library ◽  
Control Group ◽  
The Impact

Abstract Background Premenstrual syndrome (PMS) refers to a set of somatic and psychological symptoms that occur cyclically in the luteal phase of a menstrual cycle. There is no report of final result of reflexology on PMS. Therefore, the present study aimed to determine the effect of reflexology on PMS through a systematic review and meta-analysis study. Method The present study was a systematic review and meta-analysis that was conducted by searching in 8 electronic databases including PubMed, EMBASE, Cochrane Library, Web of Science, ProQuest, Scopus, Google Scholar, and SID until December 28, 2018. In this regard, interventional studies, which examined the impact of reflexology on women with premenstrual syndrome, were included. These studies were published during 1993 to 2018. The Cochrane Collaboration’s Risk of Bias Tool was used to assess the quality of studies. Meta-analysis was performed by the help of CMA 2 software. Results Nine out of 407 studies finally remained after screening, and quantitative and quantitative analyses were performed on them. The total number of research samples was 475. The mean treatment time with reflexology was 40.55 min per session that was performed in 6 to 10 sessions of treatment in 66.67% of studies. According to the meta-analysis and based on the random effects model, the reflexology could decrease the severity of PMS in the intervention group compared to the control group (SMD = − 2.717, 95% CI: − 3.722 to − 1.712). Meta-regression results indicated that the duration of intervention sessions (β = − 0.1124, 95% CI − 0.142 to − 0.084, p < 0.001) had a significant impact on the severity of PMS. Reflexology could also significantly affect somatic (SMD = − 1.142, 95% CI: − 1.481 to − 0.803) and psychological (SMD = − 1.380, 95% CI: − 2.082 to − 0.677) symptoms arising from PMS. Conclusion In general, results of the present study indicated that the reflexology could relieve PMS symptoms, so that overall scores, somatic and psychological symptoms of PMS decreased by applying the reflexology intervention. Furthermore, an increase in the length of reflexology time in each session increased its efficiency. Reflexology can be used as an effective intervention in a patient care program by nurses and its efficiency can be enhanced by increasing intervention time in each reflexology treatment session.

scholarly journals A Wearable Technology Delivering a Web-Based Diabetes Prevention Program to People at High Risk of Type 2 Diabetes: Randomized Controlled Trial

10.2196/15448 ◽  
2020 ◽  
Vol 8 (7) ◽  
pp. e15448
Author(s):  
Emily Staite ◽  
Adam Bayley ◽  
Ebaa Al-Ozairi ◽  
Kurtis Stewart ◽  
David Hopkins ◽  
...  
Keyword(s):  
Physical Activity ◽  
Controlled Trial ◽  
Intervention Group ◽  
Diabetes Prevention Program ◽  
Mean Difference ◽  
Control Group ◽  
Web Based ◽  
The Mean

Background Intensive lifestyle interventions are effective in reducing the risk of type 2 diabetes, but the implementation of learnings from landmark studies is expensive and time consuming. The availability of digital lifestyle interventions is increasing, but evidence of their effectiveness is limited. Objective This randomized controlled trial (RCT) aimed to test the feasibility of a web-based diabetes prevention program (DPP) with step-dependent feedback messages versus a standard web-based DPP in people with prediabetes. Methods We employed a two-arm, parallel, single-blind RCT for people at high risk of developing diabetes. Patients with a hemoglobin A1c (HbA1c) level of 39-47 mmol/mol were recruited from 21 general practices in London. The intervention integrated a smartphone app delivering a web-based DPP course with SMS texts incorporating motivational interviewing techniques and step-dependent feedback messages delivered via a wearable device over 12 months. The control group received the wearable technology and access to the web-based DDP but not the SMS texts. As this was a feasibility study, the primary aim was to estimate potential sample size at different stages of the study, including the size of the target study population and the proportion of participants who consented, were randomized, and completed follow-up. We also measured the main outcomes for a full-scale RCT, namely, change in weight and physical activity at 6- and 12-month follow-ups, and secondary outcomes, including changes in the HbA1c level, blood pressure, waist circumference, waist-to-hip ratio, and lipid levels. Results We enrolled 200 participants: 98 were randomized to the intervention and 102 were randomized to the control group. The follow-up rate was higher in the control group (87/102, 85.3%) than in the intervention group (69/98, 70%) at 12 months. There was no treatment effect on weight at 6 months (mean difference 0.15; 95% CI −0.93 to 1.23) or 12 months (mean difference 0.07 kg; 95% CI −1.29 to 1.44) or for physical activity levels at 6 months (mean difference −382.90 steps; 95% CI −860.65 to 94.85) or 12 months (mean difference 92.64 steps; 95% CI −380.92 to 566.20). We did not observe a treatment effect on the secondary outcomes measured at the 6-month or 12-month follow-up. For the intervention group, the mean weight was 92.33 (SD 15.67) kg at baseline, 91.34 (SD 16.04) kg at 6 months, and 89.41 (SD 14.93) kg at 12 months. For the control group, the mean weight was 92.59 (SD 17.43) kg at baseline, 91.71 (SD 16.48) kg at 6 months, and 91.10 (SD 15.82) kg at 12 months. In the intervention group, the mean physical activity was 7308.40 (SD 4911.93) steps at baseline, 5008.76 (SD 2733.22) steps at 6 months, and 4814.66 (SD 3419.65) steps at 12 months. In the control group, the mean physical activity was 7599.28 (SD 3881.04) steps at baseline, 6148.83 (SD 3433.77) steps at 6 months, and 5006.30 (SD 3681.1) steps at 12 months. Conclusions This study demonstrates that it is feasible to successfully recruit and retain patients in an RCT of a web-based DPP. Trial Registration ClinicalTrials.gov NCT02919397; http://clinicaltrials.gov/ct2/show/NCT02919397

scholarly journals Exploring Efficacy of a Serious Game (Tobbstop) for Smoking Cessation During Pregnancy: Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Francesc X Marin-Gomez ◽  
Rocio Garcia-Moreno Marchán ◽  
Anabel Mayos-Fernandez ◽  
Gemma Flores-Mateo ◽  
Esther Granado-Font ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Tobacco Use ◽  
Controlled Trial ◽  
Intervention Group ◽  
Serious Game ◽  
Control Group ◽  
Randomized Controlled ◽  
Pregnant Smokers

BACKGROUND Tobacco use during pregnancy entails a serious risk to the mother and harmful effects on the development of the child. Europe has the highest tobacco smoking prevalence (19.3%) compared with the 6.8% global mean. Between 20% to 30% of pregnant women used tobacco during pregnancy worldwide. These data emphasize the urgent need for community education and implementation of prevention strategies focused on the risks associated with tobacco use during pregnancy. OBJECTIVE The aim of this study was to investigate the efficacy of an intervention that incorporates a serious game (Tobbstop) to help pregnant smokers quit smoking. METHODS A two-arm randomized controlled trial enrolled 42 women who visited 2 primary care centers in Catalonia, Spain, between March 2015 and November 2016. All participants were pregnant smokers, above 18 years old, attending consultation with a midwife during the first trimester of pregnancy, and had expressed their desire to stop smoking. Participants were randomized to the intervention (n=21) or control group (n=21). The intervention group was instructed to install the game on their mobile phone or tablet and use it for 3 months. Until delivery, all the participants were assessed on their stage of smoking cessation during their follow-up midwife consultations. The primary outcome was continuous tobacco abstinence until delivery confirmed by the amount of carbon monoxide at each visit, measured with a carboxymeter. RESULTS Continuous abstinence until delivery outcome was 57% (12/21) in the intervention group versus 14% (3/21) in the control group (hazard ratio=4.31; 95% CI 1.87-9.97; P=.001). The mean of total days without smoking until delivery was higher in the intervention group (mean 139.75, SD 21.76) compared with the control group (mean 33.28, SD 13.27; P<.001). In addition, a Kapplan-Meier survival analysis showed that intervention group has a higher abstinence rate compared with the control group (log-rank test, χ21=13.91; P<.001). CONCLUSIONS Serious game use is associated with an increased likelihood to maintain abstinence during the intervention period if compared with those not using the game. Pregnancy is an ideal opportunity to intervene and control tobacco use among future mothers. On the other hand, serious games are an emerging technology, growing in importance, which are shown to be a good tool to help quitting smoking during pregnancy and also to maintain this abstinent behavior. However, because of the study design limitations, these outcomes should be interpreted with caution. More research, using larger samples and longer follow-up periods, is needed to replicate the findings of this study. CLINICALTRIAL ClinicalTrials.gov NCT01734421; https://clinicaltrials.gov/ct2/show/NCT01734421 (Archived by WebCite at http://www.webcitation.org/75ISc59pB)

Impact of convex ostomy appliances on leakage frequency, peristomal skin health and stomal protrusion

2021 ◽  
Vol 19 (Sup9) ◽  
pp. S30-S37
Author(s):  
Eugenia Rodriguez González ◽  
Carmen del Pino Zurita ◽  
Gemma Arrontes Caballero ◽  
Araceli Hoyo Rodríguez ◽  
Eugenia Zapatero Rodríguez ◽  
...  
Keyword(s):  
Patient Satisfaction ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Anova Analysis ◽  
Independent Variables ◽  
Peristomal Skin ◽  
Randomised Controlled ◽  
The Impact

Aim: The Convexity in Ostomy (ECOS) study measured the impact of soft convex ostomy appliances on leakage frequency, peristomal skin health, and patient satisfaction, as well as stomal protrusion and body profile. Methods: This prospective non-randomised controlled trial included people with a stoma, divided into a control group using a convex appliance throughout (Alterna Confort Convex or Easiflex Confort Convex Light, Coloplast A/S, Humlebæk, Denmark), and an intervention group who were using a flat appliance at baseline before switching to a convex appliance for the rest of the study. Leakage frequency was counted within the past 2 weeks; peristomal skin health was assessed using the discolouration, erosion and tissue overgrowth (DET) Ostomy Skin Tool; and patient satisfaction was measured with a 0-10 Likert scale of self-reported satisfaction with the appliance. Measurements were taken at three visits: baseline (V1), 2-8 weeks (V2) and 6 months (V3). The Kruskal-Wallis and analysis of variance (ANOVA) tests were used for comparison. Multiple regression analysis was used to evaluate the effect of independent variables on the change in leakage frequency and DET score between baseline and 6 months. Findings: Of 253 participants screened, 245 completed the follow-up, with 151 in the intervention group and 94 in the control group. Mean leakage frequency period went from 5.85 ± 5.55 (V1) to 0.63 ± 1.42 (V2) and 0.23 ± 0.75 (V3) (p<.0001). Mean DET score changed from 4.8 ± 3.47 (V1) to 1.41 ± 2.17 (V2) and 0.54 ± 1.57 (V3) (p<.0001). Mean satisfaction changed from 6.0 ± 2.25 (V1) to 8.6 ± 1.14 (V2) and 9.17 ± 0.93 (V3) (p<.0001). From V1 to V3, the proportion of patients with a depressed peristomal area went from 45.7% to 31.4%, a normal peristomal area went from 45.3% to 65.3%, stoma protrusion went from 31.4% to 47.3% and stoma retraction went from 28.6% to 15.5%. By group, mean leakage frequency decreased in the intervention group by 7.65, from 7.57 to 0.11, and in the control group by 2.37, from 2.94 to 0.46 (p<0.0001). Multiple ANOVA analysis confirmed independent variables in reducing leakage to be initiating convexity and appliance coupling. By group, mean DET score decreased in the intervention group by 4.82, from 5.24 to 0.42, and in the control group by 3.52, from 4.34 to 0.76. Multiple ANOVA analysis showed independent variables for DET score to be initiating convexity, emergency surgery and stoma siting. Conclusion: People with a stoma experiencing repeated leakage benefitted from shifting from a flat to a soft convex appliance in terms of leakage frequency, peristomal skin health, stomal protrusion and body profile.

scholarly journals A Randomised Controlled Trial Evaluating the Effectiveness and Tolerability of Step-up and Step-down Varenicline Therapy for Smoking Cessation: A Study Protocol

2017 ◽  
Vol 13 (3) ◽  
pp. 179-185
Author(s):  
Aaron D. Drovandi ◽  
Peta-Ann Teague ◽  
Beverley D. Glass ◽  
Bunmi Malau-Aduli
Keyword(s):  
Smoking Cessation ◽  
Adverse Events ◽  
Outcome Measures ◽  
Controlled Trial ◽  
Intervention Group ◽  
Withdrawal Symptoms ◽  
Secondary Outcome ◽  
Control Group ◽  
Step Down

Background: Varenicline remains the most effective medication for smoking cessation; however, discontinuation as a result of adverse events negatively impacts medication adherence, and the likelihood of a quit attempt being successful. Post-treatment cravings and withdrawal symptoms may also occur, increasing the likelihood of treatment failure, due to lapse and relapse after achieving initial abstinence. This protocol details a trial investigating changes in the effectiveness and tolerability of varenicline, when an extended step-up and step-down regimen are used.Methods: A phase four, randomised, double-blinded, placebo-controlled single-centre study with a treatment period of 16 weeks, and follow-up period of 12 weeks will be conducted. Up to 201 participants will be enrolled and allocated in a 1:1:1 ratio to a placebo-matching control group, step-up, or step-down intervention group, all receiving behavioural counselling and quitting advice. Participants will be contacted weekly during treatment and fortnightly during follow-up. Eligible participants are smokers over 18 years old, willing to quit smoking, are able to attend clinic visits, and have no uncontrolled or serious medical issues. Primary outcome measures are comparisons of biochemically confirmed continuous abstinence rates, 7-day point prevalence abstinence rates, and the frequency, severity and duration of adverse events, cravings and withdrawal symptoms. Secondary outcome measures are participant adherence to the study medication throughout treatment, and comparisons of changes in smoking satisfaction and reward. Effects of each regimen on smoking cessation will be assessed by logistic regression, with survival analyses used for a more precise estimate of when cessation occurs. Primary endpoints will then be compared using a general linear model. Australian New Zealand Clinical Trials Registry: ACTRN12616000802404p

scholarly journals Engagement Strategies to Improve Adherence and Retention in Web-Based Mindfulness Programs: Systematic Review (Preprint)

2021 ◽  
Author(s):  
Natalie Winter ◽  
Lahiru Russell ◽  
Anna Ugalde ◽  
Victoria White ◽  
Patricia Livingston
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trial ◽  
Trial Design ◽  
Controlled Trial ◽  
Health Conditions ◽  
Web Based ◽  
Randomized Controlled ◽  
Engagement Strategies ◽  
The Impact

BACKGROUND Web-based mindfulness programs may be beneficial in improving the well-being outcomes of those living with chronic illnesses. Adherence to programs is a key indicator in improving outcomes; however, with the digitization of programs, it is necessary to enhance engagement and encourage people to return to digital health platforms. More information is needed on how engagement strategies have been used in web-based mindfulness programs to encourage adherence. OBJECTIVE The aim of this study is to develop a list of engagement strategies for web-based mindfulness programs and evaluate the impact of engagement strategies on adherence. METHODS A narrative systematic review was conducted across the MEDLINE Complete, CINAHL Complete, APA PsycINFO, and Embase databases and followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) guidelines. Articles were screened using the population, intervention, comparator, and outcome framework. Adults aged &gt;18 years with chronic health conditions were included in the study. Mindfulness interventions, including those in combination with mindfulness-based cognitive therapy, delivered on the web through the internet or smartphone technology were included. Interventions lasted at least 2 weeks. Studies with a randomized controlled trial design or a pilot randomized controlled trial design were included. Engagement strategies, including web-based program features and facilitator-led strategies, adherence, and retention, were included. RESULTS A total of 1265 articles were screened, of which 19 were relevant and were included in the review. On average, 70.98% (2258/3181) of the study participants were women with a mean age of 46 (SD 13) years. Most commonly, mindfulness programs were delivered to people living with mental health conditions (8/19, 42%). Of the 19 studies, 8 (42%) used only program features to encourage adherence, 5 (26%) used facilitator-led strategies, and 6 (32%) used a combination of the two. Encouraging program adherence was the most common engagement strategy used, which was used in 77% (10/13) of the facilitator-led studies and 57% (8/14) of the program feature studies. Nearly two-thirds (63%) of the studies provided a definition of adherence, which varied between 50% and 100% completion across studies. The overall mean participant compliance to the mindfulness programs was 56% (SD 15%). Most studies (10/19, 53%) had a long-term follow-up, with the most common follow-up period being 12 weeks after intervention (3/10, 30%). After the intervention, the mean retention was 78% (SD 15%). CONCLUSIONS Engagement strategies in web-based mindfulness programs comprise reminders to use the program. Other features may be suitable for encouraging adherence to interventions, and a facilitator-led component may result in higher retention. There is variance in the way adherence is measured, and intervention lengths and follow-up periods are inconsistent. More thorough reporting and a standardized framework for measuring adherence are needed to more accurately assess adherence and engagement strategies.

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